[ { "Text": "AbbVie Global Enterprises Ltd
Thistle House
4 Burnaby Street
Hamilton HM11, Bermuda", "": "" }, { "Text": "24-May-23", "": "" }, { "Text": "AbCellera Biologics Inc.
Attn: Chief Legal Officer
2215 Yukon Street
Vancouver, BC V5Y 0A1
legal@abcellera.com", "": "" }, { "Text": "To Whom it May Concern:", "": "" }, { "Text": "Re: CD200R1 Research Target Substitution Notice", "": "" }, { "Text": "We refer to the Collaboration and Option Agreement between AbCellera and AbbVie dated December 14, 2022, pursuant to which AbCellera (i) assigned all rights, title, and interest in and to the Collaboration Program Assets and (ii) granted AbbVie an option to acquire all rights, title, and interest in and to applicable Option Program Assets which includes the Initial Option Program (the \"Agreement\"). Each capitalized term set forth in this letter (the \"CD200R1 Substitution Notice\") shall have the meaning given to it in the Agreement, unless otherwise defined herein.", "": "" }, { "Text": "As agreed at the previous JGC meeting (Collaboration launch meeting, 22 March 2023), the target selected for the Initial Option Program, CD200R1, no longer warrants further research. Pursuant to Section 2.3 of the Agreement, AbbVie hereby notifies AbCellera of its desire to nominate CD5/PD-1 agonism (bispecific) as the Nominated Target for substitution. In the case of (a) AbCellera providing AbbVie notice of a positive Feasibility Assessment with respect to CD5/PD-1 bispecific Research Target, or (b) AbbVie providing AbCellera notice of its desire to proceed with CD5/PD-1 bispecific Research Target despite a negative Feasibility Assessment, and in either case (a) or (b), the date on which such notice is delivered shall be deemed the \"CD5/PD-1 Confirmation Date\". Upon the CD5/PD-1 Confirmation Date, (i) the Substitute Target (CD5/PD-1 bispecific) will be deemed the \"Research Target\" with respect to the Initial Option Program; (ii) the replaced Research Target (CD200R1) will no longer be deemed to be a \"Research Target\" and AbCellera's exclusivity obligations under Section 8.1.1(b) shall no longer apply to CD200R1; and (iii) for clarity, with respect to the CD5/PD-1 bispecific Research Target, the exclusivity obligations set forth in Section 8.1.1 shall apply.", "": "" }, { "Text": "Pursuant to Section 7.3(a), the Substitution Fee to replace CD200R1 is Five Hundred Thousand Dollars ($500,000) based upon the substitution occurring before initiation of Antibody Discovery. AbbVie shall pay such Substitution Fee in accordance with Section 7.3 after the completion of all relevant activities described in Section 2.3 of the Agreement.", "": "" }, { "Text": "Notwithstanding anything to the contrary stated in Section 2.3, such substitution under this CD200R1 Substitution Notice (i.e., replacing CD200R1 with CD5/PD-1) shall not count against AbbVie's one (1) time right under Section 2.3 to substitute a Research Target for the Initial Option Program with a different target(s). For clarity, notwithstanding such substitution hereunder, AbbVie shall retain its right to make one (1) Research Target substitution with respect to the Initial Option Program in accordance with the terms of Section 2.3.", "": "" }, { "Text": "Further, it is agreed by the Parties that (i) a new Research Plan for CD5/PD-1 agonism (bispecific) shall be drafted in accordance with the last sentence set forth in Section 2.4.2, and (ii) separate Antibody Discovery campaigns and Antibody Validation and Characterization activities may be necessary to generate the bispecific antibodies. In both cases (i) and (ii) above, AbbVie shall not be responsible for any additional or increased costs.", "": "" }, { "Text": "In addition, as a result of the substitution, the Parties will now use the OrthoMab Platform Technology in the Initial Option Program, and AbbVie shall not have any additional cost or expense as a result of such use. It is hereby agreed by the Parties that the last two sentences of Section 4.1.4 of the Agreement are hereby deleted in their entirety and replaced as follows:

\"For clarity, the Collaboration Program will not require the use of the OrthoMab License. The OrthoMab License is hereby granted for use in the Initial Option Program and potential use in an Additional Option Program.", "": "" }, { "Text": "Upon execution and delivery of this CD200R1 Substitution Notice by the Parties, the amendments set forth above will become effective as of the date of this CD200R1 Substitution Notice (the \"CD200R1 Substitution Notice Effective Date\"). There are no further changes to the terms of the Agreement. Except as specifically modified or amended by the terms above, the Agreement shall remain unamended and in full force in its entirety and is hereby ratified and confirmed and constitutes the legal, valid, binding, and enforceable obligations of the Parties. All section references contained herein refer to the Agreement. References to the \"Agreement\" in the Agreement shall be deemed to include the provisions of this CD200R1 Substitution Notice.", "": "" }, { "Text": "The following provisions of the Agreement are incorporated by reference into this CD200R1 Substitution Notice, mutatis mutandis: Sections 14.1.1 (Governing Law), 14.2 (Dispute Resolution), 14.3 (Assignment), 14.7 (Waiver; Non-Exclusion of Remedies), 14.8 (Further Assurance), 14.9 (Severability), 14.12 (Entire Agreement; Amendments), 14.16 (English Language), 14.18 (Counterparts).", "": "" }, { "Text": "If this CD200R1 Substitution Notice is acceptable, please indicate your acceptance by executing this CD200R1 Substitution Notice below.", "": "" }, { "Text": "ABCELLERA BIOLOGICS INC.

By: ______________________________

Name: ______________________________

Title: ______________________________", "": "" }, { "Text": "ABBVIE GLOBAL ENTERPRISES LTD.

By: ______________________________

Name: ______________________________

Title: ______________________________

Jonathan C. Clipper

Director", "": "" }, { "Text": "Execution VersionConfidentialConfidential

AMENDMENT NO. 1 
TO

COLLABORATION AND OPTION TO LICENSE AGREEMENT", "": "" }, { "Text": "Amendment August 1, 2022 First Amendment Effective Date Heptares Therapeutics Limited, a company registered in England having its principal place of business at Steinmetz Building, Granta Park, Great Abington, Cambridge, Cambridgeshire, CB21 6DG, UK, part of the Sosei Group", "": "" }, { "Text": "Heptares AbbVie Global Enterprises Ltd. (as assignee of AbbVie Ireland Unlimited Company), a Bermuda corporation AbbVie House, Street, Hamilton HM11, Bermuda. Heptares and AbbVie are Party Parties", "": "" }, { "Text": "RECITALS 

WHEREAS, the Parties entered into that certain Collaboration and Option to License Agreement dated June 24 Agreement", "": "" }, { "Text": "WHEREAS, the Parties desire to add three (3) additional research programs in addition to the Option Programs (as defined in the Agreement) in existence prior to the First Amendment Effective Date; and", "": "" }, { "Text": "WHEREAS, the Parties acknowledge and agree that: (a) none of the amendments to the Agreement as of the First Amendment Effective Date alter or amend any of the Programs (meaning the FPR2 Program, GPR65 Program and GPR132 Program) which were the subject of the Agreement in effect as of the Effective Date; and (b) as of immediately prior to the First Amendment Effective Date), only the GPR65 Program remains in effect (subject to any Additional Option Program pursuant to Section 3.6) and that the Reserved Option Program Pre-Option Period has expired as contemplated by the letter between the Parties dated as of June 22, 2021; and (c) the purpose of the amendments to the Agreement as of the First Amendment Effective Date are because Heptares wishes to grant, and AbbVie wishes to take, exclusive options to take one or more Exclusive Licenses under certain intellectual property rights to Exploit Licensed Products in the Territory for Neurology Programs, in each case in accordance with the terms and conditions set forth below.", "": "" }, { "Text": "NOW, THEREFORE, in consideration of the premises and the mutual promises and conditions hereinafter set forth, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, do hereby agree as follows.", "": "" }, { "Text": "1. Definitions. All capitalized terms used but not otherwise defined herein shall have the meaning set forth in the Agreement.", "": "" }, { "Text": "2. Amendments to the Agreement.", "": "" }, { "Text": "2.1. The following sentence is hereby added to the end of Section 1.33 of the Agreement: 

Subject to Section 6.9.1, each Non-Selected Neurology Target shall be deemed to be an Available Target during the period of exclusivity applicable to such Target pursuant to Section 6.9.1", "": "" }, { "Text": "2.2. Section 1.145 of the Agreement is hereby deleted in its entirety and replaced as follows: 

Material Research Plan Amendment Plan that materially changes the course, scope, budget, timing, or personnel and resource requirements of the Development activities set forth therein; without limiting the foregoing, it being understood and agreed that any change to Appendix A1 or A2 of the Neurology Research Plan", "": "" }, { "Text": "2.3. Section 1.147-1 of the Agreement is hereby added after Section 1.147 of the Agreement: 

Neurology Designated Pharmacology Target arising from a Neurology Program, a small molecule antagonist, inverse agonist or negative allosteric modulator (i) that binds to an Option Target, (ii) whose primary mode of action is the inhibition of an Option Target, and (iii) for which such primary mode of action is not the inhibition of calcitonin gene related peptide receptor ( CGRP Receptor ); in each case (ii) and (iii), (x) with primary mode of action based upon the selectivity criteria set forth in the Neurology Research Plan, (y) as CGRP Receptor is defined in the Neurology Research Plan, and (z) as such Option Targets are defined in Schedule 1.147-2.", "": "" }, { "Text": "2.4. Section 1.147-2 of the Agreement is hereby added after Section 1.147-1 of the Agreement: 

Neurology Program s each of the three (3) programs for therapeutic agents specifically directed at (i) prior to the Neurology Target Selection Date, each of the Neurology Targets set forth on Schedule 1.147-2 that comprise such program or an applicable Neurology Substitute Target, and (ii) on or after the Neurology Target Selection Date, the applicable Selected Neurology Target(s), in each case (i) and (ii), in the Neurology Designated Pharmacology, including all therapeutic agents specifically directed at such Target(s) that are identified or discovered by Heptares or its Affiliates as of the First Amendment Effective Date and during the Term.", "": "" }, { "Text": "2.5. Section 1.147-3 of the Agreement is hereby added after Section 1.147-2 of the Agreement: 

Neurology Program Technical Failure Program, Heptares fails to produce at least one (1) Screening Enabled Stabilized Receptor which corresponds to at least one (1) Neurology Target comprising such", "": "" }, { "Text": "2.6. Section 1.147-4 of the Agreement is hereby added after Section 1.147-3 of the Agreement: 

Neurology Substitute Target Target included in a Neurology Program pursuant to Section 3.7-1, including Neurology Program Technical Failure Substitute Targets and Alternate Selected Neurology Targets.", "": "" }, { "Text": "2.7. Section 1.147-5 of the Agreement is hereby added after Section 1.147-4 of the Agreement: 

Neurology Target Combinations) listed in Schedule 1.147-2 and any Neurology Substitute Target, in each case, in the Neurology Designated Pharmacology", "": "" }, { "Text": "2.8. Section 1.147-6 of the Agreement is hereby added after Section 1.147-5 of the Agreement: 

Neurology Target Combinations Targets within an applicable Neurology Program in the Neurology Designated", "": "" }, { "Text": "2.9. Section 1.147-7 of the Agreement is hereby added after Section 1.147-6 of the Agreement: 

Neurology Target Selection Date Program, the date on which the JGC determines the Selected Neurology Target as set forth in Section 2.1.6-1", "": "" }, { "Text": "2.10. Section 1.147-8 of the Agreement is hereby added after Section 1.147-7 of the Agreement: 

Neurology Target Selection Period Program, the period commencing on the First Amendment Effective Date and expiring forty-five (45) Business Days following the date on which the JGC determines that all activities supporting the criteria set forth in Appendix A1 of the Neurology Research Plan have been completed for all applicable targets in such", "": "" }, { "Text": "2.11. Section 1.149-1 of the Agreement is hereby added after Section 1.149 of the Agreement: 

Non-Selected Neurology Target Program, after expiration of the applicable Neurology Target Selection Period, any", "": "" }, { "Text": "2.12. Section 1.152 of the Agreement is hereby deleted in its entirety and replaced as follows: 

Option Period the Effective Date, (ii) the Neurology Programs, the period commencing on the First Amendment Effective Date, (iii) a Reserved Option Program, the period rved Option Program Activation Notice, and (iv) for the Additional Option Program, the period commencing on Additional Option Target is an Available Target pursuant to Section 3.6.1, and, in all cases, expiring on the earlier of (a) the License Option Effective Date for an applicable Option Program, (b) ninety (90) calendar days after acceptance by AbbVie of an applicable Option Data Package, and (c) with respect to (1) Option Programs that are not Neurology Programs, a Technical Failure or failure to achieve a Validated Hit of the last Substitute Option Target for an applicable Option Program, or (2) Option Programs that are Neurology Programs, failure to achieve a Validated Hit of the last Alternate Selected Neurology Target.", "": "" }, { "Text": "2.13. Section 1.154 of the Agreement is hereby deleted in its entirety and replaced as follows: 

Option Program the GPR132 Program and/or the FPR2 Program, upon delivery of an applicable Reserved Option Program Activation Notice pursuant to Section 3.5, (iii) each Neurology Program, as of the First Amendment Effective Date, (iv) the Additional Option Program, follow Section 3.6.1, (v) an Alternate Pharmacology Option Program, upon exercise of Section 3.8, and (vi) in the case of a Technical Failure, or Neurology Program Technical Failure, as applicable, with respect to any of the foregoing pursuant to Section 3.7 or Section 3.7-1, any Substitute Option Program or Neurology Program comprising a Neurology Substitute Target, together with all applicable Option Compounds and Option Products. For clarity, terminated Programs shall not be Option Programs.", "": "" }, { "Text": "2.14. Section 1.155 of the Agreement is hereby deleted in its entirety and replaced as follows: 

Option Target means (a) GPR65, (b) with respect to each Neurology Program, (i) prior to the Neurology Target Selection Date, the Neurology Targets, and (ii) on and after the Neurology Target Selection Date, the Selected Neurology Target(s), (c) to the extent that AbbVie selects other Option Programs or Targets pursuant to its rights set forth in Sections 3.5, 3.6.1, 3.7.1, 3.7-1.1, or 3.8 ̧ the Additional Option Target, Neurology Substitute Target, Neurology Target Combination and any Substitute Option Target, as applicable.", "": "" }, { "Text": "2.15. Section 1.180 of the Agreement is hereby deleted in its entirety and replaced as follows: 

Research Plan forth (i) Development activities to be performed by AbbVie and Heptares with respect to such Option Program, and (ii) all Information that is required to be in the Option Data Package. The Research Plan for the GPR65 Program and the Reserved Option Programs shall be attached to this Agreement as Schedule 1.180 and the Research Plans for all other Option Programs shall be attached to this Agreement in the form as the Parties shall agree (subject to Sections 3.6, 3.7, 3.8.3(ii) and other applicable provisions of this Agreement). The Research Plan for the Neurology Programs shall also be attached to this Agreement in the form attached hereto as Schedule 1.180 Neurology Research Plan.", "": "" }, { "Text": "2.16. Section 1.195-1 of the Agreement is hereby added after Section 1.195 of the Agreement: 

Selected Neurology Target , subject to Sections 2.1.6-1, 2.2.3 and 3.7-1, (i) the Neurology Target(s) that are selected by the JGC for continued Development in accordance with the Neurology Research Plan prior to the expiration of the Neurology Target Selection Period, or (ii) subject to Section 3.7-1.2, an applicable Alternate Selected Neurology Target.", "": "" }, { "Text": "2.17. Section 1.205 of the Agreement is hereby deleted in its entirety and replaced as follows: 

Technical Failure for an applicable Option Target that is not a Neurology Target, Heptares fails to produce a completed Screening Enabled Stabilized Receptor which corresponds to the Option Target.", "": "" }, { "Text": "2.18. Section 2.1.6-1 of the Agreement is hereby added after Section 2.1.6 of the Agreement: 

with respect to each Neurology Program, prior to the expiration of the applicable Neurology Target Selection Period, determine the Neurology Target(s) that are Selected Neurology Targets for such Neurology Program; provided that the Selected Neurology Target(s) may comprise (i) a single Neurology Target, or (ii) Neurology Target Combination, in either case (i) or (ii), as a single Option Target; it being understood and agreed that, notwithstanding anything to the contrary contained herein, AbbVie shall only be entitled to select a maximum of three (3) Neurology Targets in the aggregate at any time during the Neurology Target Selection Period subject to Section 3.7-1", "": "" }, { "Text": "2.19. Section 2.2.3(a)(i) of the Agreement is hereby deleted in its entirety and replaced as follows: 

Neurology Target(s) or Neurology Target Combination(s) that are Selected Neurology Targets, (x) which Option Compound(s) or Option Product(s) shall become the subject of a Toxicology Study, (y) the duration of the Toxicology Study for an Option Program up to a maximum of thirteen (13) weeks, and (z) strategy, content, topics for discussion and questions to be posed with FDA at any Pre-", "": "" }, { "Text": "2.20. Section 2.2.3(a)(ii) of the Agreement is hereby deleted in its entirety and replaced as follows: 

(y) all Material Research Plan Amendments shall, in each case, be agreed upon in writing by the Parties and (z) the determination that all activities supporting the criteria set forth in Appendix A1 of the Neurology Research Plan have been completed for all applicable targets for a Neurology Program shall, in each case, be agreed upon in writing by the Parties; provided further that any Disputes that arise in connection with a Material Research Plan Amendment or the criteria set forth in Appendix A1 of the Neurology Research Plan shall be resolved pursuant to Section 13.7, and", "": "" }, { "Text": "2.21. The parties agree that the existing Section 3.7 of the Agreement shall apply solely to Option Programs that are not Neurology Programs, and that Neurology Programs shall be governed by the provisions of the new Section 3.7-1 set forth in this Amendment.", "": "" }, { "Text": "2.22. Section 3.7-1 is hereby added after Section 3.7 of the Agreement: 

-1 Failed Neurology Programs; Neurology Substitute Targets.

3.7-1.1 Neurology Program Technical Failure

(a) In the event a Neurology Program reaches Neurology Program Technical Failure, then (i) Heptares shall promptly notify AbbVie within ten (10) Business Days regarding its determination of such Neurology Program Technical Failure, and (ii) AbbVie shall, upon receipt of the foregoing notice from Heptares and subject to Section 3.7-1.1(b), have the one (1) time right, with respect to each Neurology Program in which Neurology Program Technical Failure has been notified, to add one (1) new Target in a Designated Pharmacology to the applicable Neurology Program by providing written notice of the proposed Target and Pharmacology to Heptares Neurology Program Technical Failure Substitute Target.", "": "" }, { "Text": "(b) If the Neurology Program Technical Failure Substitute Target is the Alternate Pharmacology of one of the Neurology Targets comprising the applicable Neurology Program, AbbVie shall not be obligated to pay the Alternate notice from AbbVie pursuant to Section 3.7-1.1(a), Heptares shall confirm whether the Target selected by AbbVie is an Available Target (in all Pharmacologies), and if such Target is not an Available Target in the desired Pharmacology, then AbbVie may select another Pharmacology for such Target or AbbVie may select another Target, in each case, to be a Neurology Program Technical Failure Substitute Target in accordance with the foregoing terms and conditions. Notwithstanding anything to the contrary contained herein, AbbVie only shall be entitled to select a maximum of three (3) Neurology Program Technical Failure Substitute Targets in the aggregate at any time during the Neurology Target Selection Period. In the event that Heptares considers the proposed Neurology Program Technical Failure Substitute Target to be intractable or subject to other technical constraints, Heptares and AbbVie will discuss such concerns in good faith, and AbbVie will reasonably take into account such matters raised by Heptares in determining whether it wishes to select an Available Target. If such Target is an Available Target, the Parties agree to use reasonable efforts to agree on a modification of the Research Plan for the applicable Neurology Program for each Neurology Program Substitute Neurology Research Plan the date that Heptares confirms that such Target is an Available Target or as otherwise agreed upon by the Parties, by making mutually agreeable revisions to such Research Plan, in respect of such Neurology Program Technical Failure Substitute Target; provided that such revisions are consistent with Section 3.1 and this Agreement; provided further that Heptares may not withhold agreement to a Substitute Neurology Research Plan if it is materially similar to an agreed Research Plan for a Neurology Program. The Parties covenant and agree that any Neurology Program Technical Failure Substitute Target shall be added to Schedule 1.147-2.", "": "" }, { "Text": "3.7-1.2 Failure to achieve a Validated Hit for a Selected Neurology Target

(a) In the event a Neurology Program fails to achieve a Validated Hit with respect to the Neurology Designated Pharmacology for the Selected Neurology Target for such Neurology Program as set forth in the Neurology Research Plan Selected Neurology Target Validated Hit Failure, then (i) Heptares shall promptly notify AbbVie within ten (10) Business Days regarding its determination of the occurrence of a Selected Neurology Target Validated Hit Failure, and shall include in such notification the costs that AbbVie would be responsible for paying in accordance with Section 3.7-1.2(c) upon substitution of a Neurology Target as set forth in this section, and (ii) AbbVie shall, upon receipt of the foregoing notice from Heptares and subject to Section 3.7-1.2(b), have the one (1) time right with respect to each Neurology Program, to substitute in place of such Selected Neurology Target one of the Non-Selected Neurology Targets for such Neurology Program that are listed in Schedule 1.147-2 in the Neurology Designated Pharmacology Alternate Selected Neurology Target", "": "" }, { "Text": "(b) In the event that Heptares considers the proposed Alternate Selected Neurology Target to be intractable or subject to other technical constraints, Heptares and AbbVie will discuss such concerns in good faith, and AbbVie will reasonably take into account such matters raised by Heptares. The Parties agree to use reasonable efforts to agree on a modification of the Research Plan for the applicable Neurology Program for such Alternate Selected Neurology Target (each, an Alternate Neurology Research Plan date that Heptares confirms that such Target is an Available Target or as otherwise agreed upon by the Parties, by making mutually agreeable revisions to such Research Plan, in respect of such Alternate Selected Neurology Target; provided that such revisions are consistent with Section 3.1 and this Agreement; provided further that Heptares may not withhold agreement to an Alternate Neurology Research Plan if it is materially similar to an agreed Research Plan for a Neurology Program.", "": "" }, { "Text": "(c) If a Selected Neurology Target Validated Hit Failure occurs (i) solely due to a failure to achieve the criteria set forth in Appendix A1 of the Neurology Research Plan Target Validation Criteria for an applicable Selected Neurology Target, or (ii) in cases where AbbVie has waived the Target Validation Criteria in writing, solely due to a failure to achieve Research Plan for an applicable Selected Neurology Target, in each case (i) and (ii), AbbVie will reimburse to Heptares all documented FTE Costs and Out-of-Pocket Costs incurred by Heptares and its Affiliates in carrying out the Development activities for such failed Selected Neurology Target in accordance with the then current Research Plan, such costs being those incurred in, or in respect of, the period from the selection of such failed Selected Neurology Target by the JGC up to the date on which the last of the Research Plan activities for such failed Selected Neurology Target can reasonably be wound down, and including any documented, ongoing committed costs which cannot be cancelled. Heptares shall invoice AbbVie for such costs in accordance with Section 7.9.", "": "" }, { "Text": "3.7-1.3 The Parties shall perform the Research Plan Activities in the Neurology Designated Pharmacology, as set out in the Substitute Neurology Research Plan or Alternate Neurology Research Plan, as applicable, in accordance with Section 3.2, and Heptares shall deliver to AbbVie an Option Data Package upon completion of such Research Plan Activities in accordance with Section 3.10.

3.7-1.4 Other than as set forth in Section 3.7-1.2(c), no additional c activities under any Substitute Neurology Research Plan or Alternate Neurology Research Plan under this Section 3.7-1.", "": "" }, { "Text": "2.23. Section 3.8.1 of the Agreement is hereby deleted in its entirety and replaced as follows: 

Designated Pharmacologies. The Designated Pharmacology for (i) the GPR65 Program and the Reserved Option Programs are set forth in the applicable Research Plans, and (ii) the Neurology Programs is the Neurology Designated Pharmacology, except to the extent a Neurology Program reaches Neurology Program Technical Failure pursuant to Section 3.7-1 (in which case such specific Neurology Designated Pharmacology shall no longer be in effect for purposes of this Agreement). With respect to each Option Target, the relevant Research Plan for each such Target shall provide for a program to Develop Option Compounds and Licensed Compounds directed to such Target in the Designated", "": "" }, { "Text": "2.24. Section 6.9.1 of the Agreement is hereby deleted in its entirety and replaced with the following:  

Heptares Exclusivity. In addition to the restrictions set forth in Sections 3.5 and 3.8, on a Program-by-Program basis, beginning on the Effective Date and ending on the earlier of (i) expiration of the Option Period; provided that AbbVie did not exercise the License Option, (ii) termination of a Licensed Program, and (iii) expiration or termination of this Agreement in its entirety, Heptares shall not, itself or with or through any Affiliate or Third Party, directly or indirectly, Exploit, or license, authorize, appoint or otherwise enable any Third Party to Exploit in the Designated Pharmacology (a) any Compound or Product for any purpose other than performance of the Research Plan Activities or any other express obligations pursuant to this Agreement, (b) any Competing Product for any purpose, or (c) solely during the Option Period, any molecule, compound or other therapeutic that is specifically directed to any Non-Selected Neurology Target.", "": "" }, { "Text": "2.25. Section 7.1.1 of the Agreement is hereby deleted in its entirety and replaced as follows: 

Upfront Payment. No later than ten (10) days following the Effective Date, AbbVie shall pay Heptares a one-time upfront amount equal to Ten Million Dollars ($10,000,000) in consideration of a License Option to the GPR65 Program. No later than ten (10) days following the First Amendment Effective Date, AbbVie shall pay Heptares a one-time upfront payment equal to Forty Million Dollars ($40,000,000) in consideration of a License Option to the Neurology Programs.", "": "" }, { "Text": "2.26. The last sentence of Section 7.1.5 of the Agreement is hereby deleted in its entirety and replaced as follows: 

The maximum aggregate amount payable by AbbVie pursuant to this Section 7.1.5 is One-Hundred and Five Million Dollars ($105,000,000).", "": "" }, { "Text": "2.27. Section 7.1-1 is hereby added to the Agreement after Section 7.1 of the Agreement: 

Neurology Research Milestones. In partial consideration of the rights granted by Heptares to AbbVie hereunder and subject to the terms and conditions set forth in this Agreement, AbbVie shall pay to Heptares within sixty (60) days after (i) achievement of the corresponding milestone event for the Neurology Programs and accordance with Section 3.5, each of the following milestones, calculated as follows:", "": "" }, { "Text": "No. Milestone Event Milestone Payment
1 Delivery of five (5) different, completed Stabilized Receptors which correspond to five (5) different Neurology Targets in any of the Neurology Programs - Ten Million Dollars ($10,000,000)
2a The occurrence of the first Validated Hit in the Neurology Designated Pharmacology which corresponds to a Neurology Target - Ten Million Dollars ($10,000,000)
2b The occurrence of the second Validated Hit in the Neurology Designated Pharmacology in a different Neurology Program than the Neurology Program described in Milestone Event No. 2a; it being understood that if AbbVie selects two (2) Neurology Targets in one (1) Neurology Program, the occurrence of the second Validated Hit may be in any Neurology Program - Ten Million Dollars ($10,000,000)
2c The occurrence of the third Validated Hit in the Neurology Designated Pharmacology in any Neurology Program - Ten Million Dollars ($10,000,000)", "": "" }, { "Text": "Each milestone payment in this Section 7.1-1 shall be payable only once in connection with this Agreement and (except as provided in the immediately succeeding sentence) only after first achievement of the corresponding milestone event and no amounts shall be due for subsequent or repeated achievements of such milestone event whether for the same Neurology Program or a different Neurology Program, including with respect to any Substitute Option Programs or Alternate Pharmacology Option Programs. Notwithstanding anything to the contrary contained herein, on a Neurology Program by Neurology Program basis, in the event (i) Milestone Payment No. 2 in Section 7.2 Lead Optimization becomes due and payable for an applicable Option Target in the Neurology Designated Pharmacology and (ii) a Milestone Payment set forth in this Section 7.1-1 has not yet been paid for such applicable Option Target, then such unpaid Milestone Payment shall then become due and payable at the same time; provided, a single occurrence of Milestone Payment No. 2 in Section 7.2 shall not cause more than one of Milestone Payment 2a, 2b and 2c to become due or payable. The maximum aggregate amount payable by AbbVie pursuant to this Section 7.1-1 is Forty Million Dollars ($40,000,000).", "": "" }, { "Text": "2.28. Row 1 of the Table in Section 7.2 of the Agreement is hereby deleted in its entirety and replaced as follows:", "": "" }, { "Text": "No. Milestone Event Milestone Payment

1 Delivery of a completed Stabilized Receptor which corresponds to the Option Target (not including any Stabilized Receptors which correspond to Neurology Targets) - Two Million Five Hundred Thousand Dollars ($2,500,000)", "": "" }, { "Text": "2.29. Clauses (i) and (ii) in the second sentence after the table set forth in Section 7.2 of the Agreement is hereby deleted in its entirety and replaced as follows: 

Section 7.2 is (i) (A) with respect to Option Programs that are not Neurology Programs, Twenty Two Million Five Hundred Thousand Dollars ($22,500,000), and (B) with respect to Neurology Programs Twenty Million Dollars ($20,000,000), plus, in each case (A) and (B) to the extent applicable in accordance with Section 3.9, the Incremental Manufacturing Cost Amount and the Second Toxicology Study Cost Amount in connection with an applicable Option Program, and (ii) One Hundred Fifty Million Dollars ($150,000,000) plus, to the extent applicable in accordance with Section 3.9, the Incremental Manufacturing Cost Amount and the Second Toxicology Study Cost Amount in connection with all of the Option Programs under this Agreement.", "": "" }, { "Text": "2.30. Clause (ii) in the second sentence after the table set forth in Section 7.3 of the Agreement is hereby deleted in its entirety and replaced as follows: 

Four Hundred Fifty-Five Million Dollars ($455,000,000) in connection with all of the Licensed Programs under this Agreement", "": "" }, { "Text": "2.31. Clause (ii) in the second sentence after the table set forth in Section 7.4 of the Agreement is hereby deleted in its entirety and replaced as follows: 

Six Hundred Eighty-Two Million Five Hundred Thousand Dollars ($682,500,000) in connection with all of the Licensed Programs under this", "": "" }, { "Text": "2.32. Clause (ii) in the second sentence after the table set forth in Section 7.5.1 of the Agreement is hereby deleted in its entirety and replaced as follows: 

Four Hundred Million Dollars ($1,400,000,000) in connection", "": "" }, { "Text": "2.33. Section 13.8.2 of the Agreement is hereby modified as follows: 

If to AbbVie, to: 4th Floor, Washington House
16 Church Street
Hamilton HM 11, Bermuda
Attention: AbbVie Global Enterprises Ltd.", "": "" }, { "Text": "If to Heptares, to: 

Heptares Therapeutics Ltd, 
Steinmetz Building, Granta Park
Great Abington, Cambridge
Cambridgeshire, 
CB21 6DG, 
UK 
Attention: Chief Executive Officer
Email: Chris.Cargill@soseiheptares.com 
Telephone: +44 (0) 1223 949 100  

With a copy (which shall not constitute notice) to the same address, 

Heptares Therapeutics Ltd, 
Steinmetz Building, Granta Park
Great Abington, Cambridge
Cambridgeshire, 
CB21 6DG, 
UK 
Attention: Company Secretary 
Email: Mariko.Nakafuji@soseiheptares.com", "": "" }, { "Text": "2.34. Schedule 1.147-2 (Neurology Programs), attached hereto as Attachment 1, is hereby attached to the Agreement.", "": "" }, { "Text": "2.35. Schedule 1.180 (Research Plans) to the Agreement is amended to include attached Attachment 2.", "": "" }, { "Text": "3. Representations and Warranties.", "": "" }, { "Text": "3.1. Heptares and AbbVie each represents and warrants to the other, as of the First Amendment Effective Date, solely with respect to this Amendment, each of the representations and warranties set forth in Section 10.1 of the Agreement, mutatis mutandis.", "": "" }, { "Text": "3.2. Heptares further represents and warrants to AbbVie, as of the First Amendment Effective Date, it is not under any obligation, contractual or otherwise, to any Person that conflicts with or is inconsistent in any material respect with the terms of the Agreement as amended by this Amendment, or that would impede the diligent and complete fulfillment of its obligations under the Agreement or this Amendment.", "": "" }, { "Text": "3.3. Heptares further represents and warrants to AbbVie, as of the First Amendment Effective Date, solely with respect to the Neurology Programs, each of the representations and warranties set forth in Section 10.2 of the Agreement, mutatis mutandis, except as set forth in the corresponding section of Schedule 10.2 delivered prior to or on the Effective Date.", "": "" }, { "Text": "4. Effect of this Amendment. This Amendment shall become effective as of the First Amendment Effective Date. There are no further changes to the terms of the Agreement. References to the ment shall be deemed to include the provisions of this Amendment. Except as would be inconsistent with the terms of this Amendment, all other terms and conditions of the Agreement shall remain in full force and effect and be unaffected by this Amendment.", "": "" }, { "Text": "5. Incorporation by Reference. The following provisions of the Agreement are incorporated by reference into this Amendment, mutatis mutandis: Sections 13.5 (Severability), 13.6 (Governing Law, Jurisdiction and Service), 13.7 (Dispute Resolution), 13.8 (Notices), 13.9 (Entire Agreement; Amendments), 13.10 (English Language), 13.11 (Equitable Relief), 13.12 (Waiver and Non-Exclusion of Remedies), 13.13 (No Benefit to Third Parties, 13.14 (Further Assurances), 13.15 (Relationship of the Parties), 13.17 (Counterparts; Execution), 13.19 (Schedules), and 13.20 (Construction).", "": "" }, { "Text": "[Signature Page to Follow]", "": "" }, { "Text": "THIS AMENDMENT NO. 1 IS EXECUTED by the duly authorized representatives of the Parties as of the First Amendment Effective Date.", "": "" }, { "Text": "HEPTARES THERAPEUTICS LIMITED ABBVIE GLOBAL ENTERPRISES LTD.

By: ___________________________

Name:  

Title:  



By: ___________________________

Name:  

Title:  

Director, Heptares Therapeutics Limited

Chris Cargill", "": "" }, { "Text": "THIS AMENDMENT NO. 1 IS EXECUTED by the duly authorized representatives of the Parties as of the First Amendment Effective Date.

HEPTARES THERAPEUTICS LIMITED ABBVIE GLOBAL ENTERPRISES LTD.

By: ___________________________ By: ___________________________

Name: Name: 

Title: Title:", "": "" }, { "Text": "ATTACHMENT 1 

Schedule 1.147-2 

Neurology Programs 

As of the First Amendment Effective Date, the Parties understand and agree that the three (3) Neurology Programs referred to in this Agreement shall be as follows: the Adrenomedullin Target Group, the Amylin Target Group and the PACAP Target Group (and as may be otherwise amended to include Available Targets in accordance with Sections 2.1.6, 2.2.3 and 3.7).", "": "" }, { "Text": "PACAP Target Group consists of (i) the pituitary adenylate cyclase-activating peptide 1 receptor PAC1 ; (ii) the vasoactive intestinal peptide 1 receptor VPAC1 ; and (iii) the vasoactive intestinal peptide 2 receptor VPAC2", "": "" }, { "Text": "Adrenomedullin Target Group consists of (i) the adrenomedullin 1 AM1 also CLR/RAMP2 complex of CLR (calcitonin receptor-like receptor) and RAMP2 (receptor activity modifying protein 2) and (ii) the adrenomedullin 2 AM2 CLR/RAMP3 R (calcitonin receptor-like receptor) and RAMP3 (receptor activity modifying protein 3).", "": "" }, { "Text": "Amylin Target Group consists of (i) the amylin 1 AMY1 also known as CTR/RAMP1 CTR (calcitonin receptor) and RAMP1 (receptor activity modifying protein 1); (ii) the amylin 2 re AMY2 also known CTR/RAMP2 CTR (calcitonin receptor) and RAMP2 (receptor activity modifying protein 2); and (iii) the amylin 3 AMY3 also CTR/RAMP3 CTR (calcitonin receptor) and RAMP3 (receptor activity modifying protein 3).", "": "" }, { "Text": "ATTACHMENT 2 

Schedule 1.180 

Research Plan", "": "" }, { "Text": "PROJECT NEU HIGHLAND 

Neurology Research Plan 

Adrenomedullin (AM), Amylin (AMY) and Pituitary Adenylate Cyclase-Activating Peptide (PACAP) Receptor Targets for the treatment of Migraine", "": "" }, { "Text": "OBJECTIVE 

The overall goal of this collaboration is the advancement of novel therapeutic targets for the treatment of migraine, with potentially transformative efficacy compared to standard of care. The initial phase (Stage I & II) will focus on the evaluation and generation of key datasets with three target groups of neuropeptide receptors viz., adrenomedullin (AM), amylin (AMY) and Pituitary adenylate cyclase-activating peptide (PACAP) so as to determine which target(s) can be prioritized for advancement into the second phase of the collaboration. During the second phase of the collaboration (Stage III), selected target profiles from AM, AMY and PACAP receptor groups will be further advanced through the lead generation and lead optimization process to identify IND candidate(s).", "": "" }, { "Text": "The projected duration of the initial phase of the collaboration is expected to be approximately 3 years. The PACAP target group will be accelerated, with the selected target within the target group advanced to lead generation activities by the end of year 2. The additional 2 groups will take an additional year to reach lead generation.", "": "" }, { "Text": "Human studies demonstrated that infusion of AM, AMY and PACAP neuropeptides cause migraine in migraineurs (Ghanizada et al., Cephalalgia 2020; Ashina et al., Cephallalgia 2017; Ashina et al., Brain 2009; Ghanizada et al, Ann Neurol. 2021; Irimia et al., Cephalalgia 2020), and the blood levels are increased for these neuropeptides during a migraine attack (Hanci et al., Cephalalgia 2021; Irimia et al., Cephalalgia 2020). The hypothesis is modulation of one or more of receptors for these neuropeptides can prevent migraine attack in patients. Importantly, such approaches may offer the potential for migraine freedom- achieving higher efficacy levels or higher response rates compared to standard of care.", "": "" }, { "Text": "The known receptors for AM, AMY and PACAP neuropeptides belong to GPCR class. Sosei Heptares has industry-leading GPCR-targeted Stabilized Receptor (StaR®) technology expertise and Structure-Based Drug Design platform capabilities with established track record in drugging GPCRs. Moreover, Sosei Heptares has already established / have access to capabilities in migraine discovery including several relevant in vitro and in vivo assays for targets/mechanisms of interests.", "": "" }, { "Text": "The initial stage of the collaboration will focus on target progression activities, including tool generation, expression/structural studies, assay development and preclinical validation studies in vivo and in vitro. Currently contemplated activities and estimates of timelines are depicted on Figure 1 and 2. Upon completion of Stage I and II and selection of candidate target(s) / target profile, the program(s) would advance to Lead Generation / Optimization towards the intended goal of Candidate Nomination. Up to three Selected Neurology Target(s) will be nominated after the completion of activities listed in Appendix A1 and Validated Hit(s) will be achieved upon completion of the activities listed in Appendix A2. The Selected Neurology Target could be an inhibitor for one receptor or combination of receptors from the same target group.", "": "" }, { "Text": "During the first phase of the collaboration, the team will strive to address the following questions:
What is the efficacy profile achieved via respective modulation of AMY/AM/PACAP receptors in relevant models of migraine? 
 What is the contribution of receptor subtypes (AM1, AM2 / AMY1, AMY2, AMY3 / PAC1R, VPAC1, VPCA2) to the efficacy profile? Related, what is the understanding of any target-based safety issues, especially GI and cardiovascular effects? 
 Which receptor subtype(s) would need to be targeted/prioritized? What is the required target profile of small molecules? In particular with PACAP, which target(s) (e.g. PAC-1, VPAC1, VPAC2 or pan) would need to be prioritized, especially in the light of available / pending clinical data with antibody-based approaches?
 Would a combination of CGRP antagonism and AM/AMY/PACAP receptor modulation confer superior efficacy profile vs. just CGRP-based approaches alone?", "": "" }, { "Text": "As noted previously, the overall research plan may be roughly divided into 3 Stages, as outlined below:

Stage I (8 receptors)
 Assay Development
 StaR generation
 Tool generation
 Target validation (in vitro & in vivo with literature tools and peptidic tools that Heptares generated)

Stage II ( receptors or receptor combinations)
 Structure determination
 Hit ID
 Target validation (in vitro & in vivo)

Stage III (1-3 programs for Validated Hit(s)) 
 Lead Generation 
 Lead Optimization 
 Candidate Nomination to Candidate Selection
 Candidate Selection to IND", "": "" }, { "Text": "I) Outline of research plan 

Key deliverables are indicated. In Year 1, in vivo model validation (with tool compounds) will be initiated.

Research Plan Details

Initial focus of the research will be to enable tool generation, structural enablement and target validation of the superfamily of receptors in order to identify the most compelling target(s) both in terms of efficacy and safety to advance into lead optimisation. It is anticipated that the initial target validation/profile definition will be performed with peptides as tools, or with literature tool compounds where appropriate. Some optimisation and refinement of peptide profiles will likely be required, with associated peptide synthesis. 

-house work will concentrate on computational chemistry, medicinal chemistry, in vitro pharmacology, DMPK, stabilised GPCR (StaR) generation and structural biology to enable the generation of one or more Clinical Candidates. Literature tool compounds to be accessed or synthesized for in vitro / in in vivo evaluation, as appropriate. 

Primary screening (native conformation GPCR expressed by a cell, StaR binding and functional assays) and appropriate secondary screening (selectivity assays, etc.) will be performed by Sosei Heptares.

Other activities outlined in this research plan will be outsourced through existing vendors or identification of new vendors. Activities specifically performed by AbbVie will be described in the research proposal.", "": "" }, { "Text": "Stage I: Target enablement and initial validation

Figure 1: GANTT for PACAP target group accelerated stage 1 and 2", "": "" }, { "Text": "Figure 2: GANTT for Amylin and Adrenomedullin receptor groups", "": "" }, { "Text": "Deliverables for Stage I & II:", "": "" }, { "Text": "Figure 3: Initial target validation funnel for Stage I & II:", "": "" }, { "Text": "Target Enablement:

1. Assay development
Primary screening assays will be established in house in order to be able to support generation or selection of appropriate tool compounds (and all subsequent screening strategies during later phases of the programs i.e. during Hit ID, lead generation and lead optimisation). Rodent orthologue receptor cell lines will need to be generated to support target validation as required.", "": "" }, { "Text": "2. Tool generation
To establish validity of each of the individual receptors within the superfamilies of Adrenomedullin, Amylin and PACAP receptors, selective peptidic tools are required (for each of the subfamilies as well as within a subfamily). 

Some of these tools exist within the literature and will be synthesised or purchased by Heptares. Where there are no available tools, a peptide design and synthesis campaign of modification of the parent peptide will enable selective tools to be generated. Heptares has significant previous expertise in this area. 

Full length agonist peptides can be truncated, guided by pre-existing structural biology insights from peptide-receptor complexes, to deliver inhibitors. There is a significant body of literature already supporting this area for the overall target groups being studied. A comprehensive literature analysis will be undertaken to select peptides for synthesis (or acquisition) as potential tools for each receptor subtype and then depending on the pharmacological profile further modifications to the sequences may be undertaken. Prototype tools will be further characterised to understand their suitability for use in animal models and the peptide sequence may need additional modifications to allow appropriate target cover via IV or SC administration. For example, addition of lipid side chain modifications may be required to extend half-life to ensure utility in vivo. 

Design and synthesis of peptide chemical biology probes (e.g. fluorescent ligands) will also be considered to enable more detailed protein detection and potential target engagement studies as part of the validation process.

For some of the receptor subtypes there is a limited body of literature on small molecule tools. The most promising compounds will be synthesised and characterised in addition to the focused program of work on peptides above. In all likelihood, Small Molecule Entities (SMEs) may not be optimal and may require significant optimisation to deliver useful selective tools and a peptide-based approach is likely preferable in most cases. Nonetheless, a similar detailed literature analysis on SMEs will be undertaken for each receptor subtype and potential tools synthesised and characterised. See Appendix A1 for definition of suitable tool for in vitro and in vivo validation.", "": "" }, { "Text": "3. Structural Biology 
Structural biology activities will involve stabilisation, expression, purification, structure determination and biophysical analysis of the adrenomedullin receptors and amylin receptor isoforms, together with the PAC1, VPAC1 and VPAC2 receptors. 
The adrenomedullin and amylin receptors are composed of the calcitonin receptor (CTR) or calcitonin receptor-like receptor (CLR), which are Family B GPCRs, and receptor activity-modifying proteins (RAMPs). The combination of CTR or CLR with different RAMPs forms receptors for amylin, CGRP, and adrenomedullin as indicated in the table below:

Receptor Base RAMP Receptor Ligand
CTR RAMP1 AMY1 AMY
CTR RAMP2 AMY2 AMY
CTR RAMP3 AMY3 AMY
CLR RAMP1 CGRP CGRP
CLR RAMP2 AM1 AM
CLR RAMP3 AM2 AM

Sosei Heptares has previously generated novel ligands for the CGRP receptor. To accomplish this, the structure of the extracellular domains of CLR and RAMP1 were solved and used for structure-based drug design (SBDD) (Bucknell et al., J. Med. Chem. 2020, 63, 14, 7906 7). 

The PAC1 receptor is also a member of the Family B of GPCRs, and in common with the VPAC1 and VPAC2 receptors, bind the PACAP peptide. Sosei Heptares also has prior experience in stabilising and determining the structure of Family B receptors in the antagonist conformation, namely CRF1 (Hollenstein et al., Nature, 2013, 499, 438 443; Kean et al., Sci Rep, 2015, 5, 11954) and the glucagon receptor (Jazayeri et al., Nature, 2016, 533, 274-7).", "": "" }, { "Text": "a. Extracellular domains of AM and AMY receptors

Initial work on the AM and AMY receptors will involve expression and purification of the extracellular domains of CLR or CTR and the corresponding RAMP, using the same approach as was utilised for the CGRP receptor. The extracellular domains will be expressed in mammalian cells. The expressed protein will be purified via fused tags, utilising the optimised protocols that were established for the CGRP receptor. The structure of the purified proteins will be solved using X-Ray crystallography. This will be carried with the extracellular domains of the receptor and associated RAMP bound to small molecule or peptide inhibitors, to map the binding site of these molecules. The purified extracellular domains will also be used for identifying novel hit matter by screening in-house compound libraries via Surface Plasmon Resonance (SPR) or by using a DNA-encoded library (DEL).", "": "" }, { "Text": "b. StaR generation 

In addition to utilising the isolated extracellular domains of the AM and AMY receptors, the full-length receptor-RAMP complexes will also be analysed. This will allow the identification of non-orthosteric binding sites, or potentially changes to the extracellular orthosteric site that are only evident in the context of the full-length protein. To accomplish this, these receptor-RAMP complexes will have to be stabilised using the Sosei Heptares proprietary StaR and SaBRE technology. Stabilisation will also be required to purify the PAC-1, VPAC1 and VPAC2 receptors. 
Thermostability assays will be established for each receptor, consistent with their use for inhibitor discovery, using small molecule or peptide inhibitors, or ligand-free fluorescence-based assays. Nanobodies or other specific, high affinity binders targeting these receptors will be generated, as these would be of utility in stabilisation of these receptors, and for downstream structure determination. 

mutagenesis protocols and by utilising information from the literature together with in-house stability and structural data from related receptors. Stabilising mutations identified in the thermostability assays, will be combined to shift the receptor gradually to an inactive (antagonist) conformation and increase its thermostability. Once the receptor has been stabilised to the point that sufficient quantities can be purified to homogeneity in detergent micelles, attempts to carry out biophysical techniques such as SPR will be initiated to try to map ligand binding sites and to start screening in-house compound libraries. In addition, DEL screening can be utilised to support hit identification. 

Initial analysis by Cryo-EM or X-ray crystallography may be carried out with these initial StaR proteins, however further stabilisation may be required for structural studies, in particular where co-structures of weakly binding ligands are required. 

Deliverable: The sequences of stabilised receptors with increased thermostability, suitable for biophysical screening and structure determination.", "": "" }, { "Text": "c. StaR expression and purification

StaRs will be expressed in insect or mammalian cells using the baculovirus system. A variety of approaches, such as a range of tags, codon optimisation, additives, enzyme cleavage and further mutagenesis, will be investigated to optimise the levels of receptor expression and to obtain homogeneous protein. For crystallisation, multiple constructs including truncations of flexible extra-helical regions of the protein and fusion proteins will be evaluated. Optimised purification and solubilisation protocols will be established for each StaR.

Deliverable: Stabilised receptors (>90% purity) suitable for biophysical screening and structure determination. QC by SDS PAGE, gel filtration, and mass spectrometry.", "": "" }, { "Text": "d. Biophysics

The primary platform for biophysical studies at Sosei Heptares will be SPR, in which the StaR is immobilised to a sensor chip, usually through a decahistidine tag. The affinities and kinetics of binding of tool inhibitors, or inhibitors generated by the project, can then be monitored. This information will be combined with binding and functional data from in vitro pharmacology to provide a comprehensive characterisation of the behaviour of the inhibitor molecules. If necessary, binding site poses can be assessed by SPR analysis of receptor mutants. SPR on the immobilised StaR will also be used for screening of in-house compound libraries. The purified receptors should also be suitable for screening DNA-encoded libraries. 

Deliverable: Information on the affinities, kinetics and binding poses of compounds will be used to refine models of binding to the receptor and assist with compound optimisation along with homology models used to propose experiments and interpret results. Screening of in-house compound libraries or DNA-encoded libraries.", "": "" }, { "Text": "4. In vitro Target Validation:

Target validation will demonstrate that the target is directly involved in a disease/mechanism process, and that engagement of the target will modulate its function and is likely to have a therapeutic effect. The following criteria are described to provide a framework for a multi-validation approach. Not all the following criteria described are necessary/critical for target validation, they serve as guidelines to achieve the criteria outlined for Selected Neurology Targets listed under Appendix A1 and depicted in Figure 4.", "": "" }, { "Text": "In vitro / ex- vivo utilising tool compounds

a. Establish receptor localisation in human and rodent trigeminal system for all 8 of the receptors under study (including RAMPs) as well as CGRP. Look for evidence of colocalization which may be indicative of synergy with CGRP or other target group members.
Critical for addressing the relative role for each receptor in the initiation and propagation of migraine is confirming localisation in the human trigeminal system (TG). This system comprises afferent fibres, cell bodies and satellite cells. We will establish localisation of each of the receptors following the methodology of Edvinsson et al., (2020). Thus, we will employ single or double immunohistochemistry and / or multicolor RNAscope to sections of human TG using primary antibodies against RAMP1/2/3, CLR, CTR, PAC1, VPAC1 and VPAC2. We will also run expression studies in the rodent. If it is possible to access tissue of sufficient quality, we will also evaluate receptor expression in the TG system of a chronic migraine rodent model (e.g. Oshinsky Model). The outcome of these studies will inform probability of efficacy in rodent pain models in addition to providing increased confidence of a potential role of one or more of these receptors in migraine.", "": "" }, { "Text": "b. Confirm in vitro properties of tool compounds on various signaling pathways (e.g., cAMP, Ca, IP etc.) in transfected cells or native systems (e.g., trigeminal neurons as needed)
As part of the target enablement, we will generate human and rodent orthologue cell lines for all the target receptors to ensure tool activity and selectivity. We will also confirm signalling in these cells, although for routine screening we will focus on a single marker of cell activation which provides the most robust signal. Importantly, for target validation we will evaluate effect of agonists and tool inhibitors directed against those receptors confirmed in expression studies to be present on TG neurones, or other cell types identified in 4a from rat. These studies will use either dynamic mass redistribution (DMR), GTPgS, cAMP or Ca2+ signalling as a measure of activation. iPSC derived trigeminal neurones have been described in the literature (Simmer et al., 2018). We will explore feasibility of this work to model cell types identified in 4.a. to endogenously express receptors, and if achievable we will also evaluate selected tools on these cells.", "": "" }, { "Text": "c. Address / confirm species differences (if any)
Both the studies in part a and part b above are aimed specifically to understand whether there are any differences in either distribution and or function between human and rodent receptors. Clearly if there is expression in human but not rodent TG then we will need to explore alternative models of the receptor function in our rodent studies, focussing on a system that expresses the receptor in question. However, targets which demonstrate conserved expression may represent a more attractive target to pursue.", "": "" }, { "Text": "d. Mechanistic studies
Functional activation of receptors that are expressed on satellite cells will not be able to be studied using isolated TG neurons but may be studied using slower calcium waves (e.g., via Fura-2 AM). Moreover, even neuronally expressed receptors may be involved in additional roles beyond just cell excitability. Therefore, we will evaluate the effect of application of an inflammatory soup on isolated trigeminal ganglia and measure neuropeptide release (via mass spec analysis) and cellular excitation via DMR / GTPgS or Ca2+ signalling.", "": "" }, { "Text": "e. Confirm vaso-activity (if applicable)
Infusion of endogenous neuropeptides such as PACAP and VIP induce significant vasodilation in humans and may be partly responsible for the induction of symptoms of migraine. Effects of these peptides and corresponding selective tool inhibitors will be evaluated on isolated rodent cerebral blood vessels. There is also the potential to confirm receptor expression on human cerebral vasculature via in situ hybridization, scRNA-seq published datasets, or immunohistochemistry. Additionally, an effect of a compound can be evaluated in isolated human peripheral blood vessels in vitro. 

Following completion of the in vitro validation, it is possible that we may have identified a potential role for all 8 receptors or more likely narrowed down the targets of interest. In the latter case, only those where in vitro validation justifies further exploration will be the target(s) that will be progressed into the in vivo validation described below (Stage II).", "": "" }, { "Text": "Stage II: Structure determination, Hit ID and in vivo target validation

1. Structure determination

Structure determination will be carried out by X-ray crystallography or cryo-electron microscopy. Crystallisation trials will be set up for several constructs using a wide range of detergent conditions. These will include standard crystallisation screens as well as proprietary Sosei Heptares screens designed for GPCR crystallisation. Crystallisation in both vapour diffusion and lipidic cubic phase will be attempted. Co-crystallisation with multiple ligands may also be carried out, including, where possible, screening hits. During the lead optimisation phase, co-crystallisation experiments with program compounds may also be attempted, if they are considered to have sufficient potency and solubility. The StaR will also be subjected to evaluation for structure determination by Cryo-EM. Once suitable samples are obtained, EM grids will be vitrified and screened in-house using a 200keV Glacios microscope and grids of suitable quality will be taken for high resolution data collection using a 300keV Titan Krios microscope at the Cambridge Pharmaceutical Cryo-EM Consortium (CPCC).", "": "" }, { "Text": "A crystal structure of the receptor, suitable for structure-based drug design, should meet the following criteria: 

Data Statistics/Resolution: Maximum resolution of greater than, or equivalent to, 3.5 Å; where this is determined by STARANISO but in general should correspond to a CC1/2 of not less than shell. Overall, the final dataset should have an associated Rpim of not more than 0.40, and a CC1/2 value equal to or greater than 0.8 with an overall completeness equal to, or greater than, 80%.", "": "" }, { "Text": "Model Building and Refinement: The final statistically validated atomic model for the target molecule should have associated and appropriate Rwork / Rfree values and ratios for the Resolution of the diffraction data as defined by: Rfree and the Rfree ratio according to: Derivation of expected values of cross-validation residuals used in macromolecular least-squares refinement; Tickle I.J., Laskowski R.A. & Moss D.S. Acta. Cryst., Vol. D54, (1998), 547-557 and Rfree and the Rfree ratio. Calculation of the expected values and variances of cross-validation statistics in macromolecular least squares refinement; Tickle I.J., Laskowski R.A. & Moss D.S. Acta. Cryst., Vol. D56, (2000), 442-450. The Molprobity score shall be above average for structures of equivalent resolution (Williams et al., Protein Science, 27, (2018), 293-315). Local measures of model quality in the ligand binding region, such as low B-factors, RSR, and RSCC (Jones T.A. et al., Acta Cryst. Vol. A47, (1991), 110-119), should be sufficient to ensure confidence in ligand and side chain placement, as well as identifying locations of uncertainty in the model. RSCC of relevant regions should correspond to omit density and not refined density. The STARANISO program from Global Phasing (Tickle, I.J., Flensburg, C., Keller, P., Paciorek, W., Sharff, A., Vonrhein, C., Bricogne, G. (2018). STARANISO (http://staraniso.globalphasing.org/cgi-bin/staraniso.cgi ), Cambridge, United Kingdom: Global Phasing Ltd.) there refinement and subsequent reflection weighting with ellipsoidal truncation is the preferred processing suite for generating final crystallographic data statistics.", "": "" }, { "Text": "A Cryo-EM structure of the receptor should meet the following criteria:

Resolution in the region of the ligand binding site of at least 3.80 Å at an FSC figure of 0.143, in line with the principles described in Rosenthal P.B. & Henderson, R. J. Mol. Biol. (2003), 333: 721-745. The structure maps should be as good or better than an X-ray structure of the same resolution, with good definition of the ligand(s) and surrounding protein residues and be of sufficient quality to enable drug discovery activities.

Deliverable: Merged diffraction images, motion corrected Cryo-EM movies, coordinates (pdb), reflection files (mtz), electron potential maps (mrc) (x-ray and Cryo-EM).", "": "" }, { "Text": "2. In vivo Validation

a. Migraine efficacy (behavior)
For assessing migraine efficacy, the nitroglycerine-induced (NTG) model will be the primary choice, and secondary models (such as inflammatory soup-induced migraine) may be considered if warranted. The sequence of activities is outlined in Figure 3 and 4. Both the acute and sub-chronic NTG model will be considered for throughput purposes, evaluation of preventative vs treatment dosing, and max efficacy over time (after steady state established). Models will be validated with standard clinical benchmarks (e.g., gepant, triptans), and with a demonstration of a sufficient disease window on critical endpoints (e.g., facial allodynia, rearing behaviors). Specific pharmacology will only be assessed if shown to have human and rat cross reactivity in in vitro assays. Efficacy of full dose-response curves will be evaluated for target validation and for comparison across targets. At the conclusion of the study relevant tissue and fluids may be collected for histological (IHC) or biomarker analysis to further evaluate MOA, PK/PD, and/or target engagement.", "": "" }, { "Text": "b. PD models 
 We will use acute models to define PK and efficacy of tool compounds as needed. These will be bespoke dependent upon the target. Thus, for PACAP and adrenomedullin receptors we will exploit the cardiovascular effects. For amylin receptors we will evaluate effect on blood glucose/ glucagon / and or GI motility. 

The in vivo activities may be conducted using a CRO (TBD). A list of CROs to be chosen from is in Appendix I. In addition to the models available via a CRO, the AbbVie Discovery Pain Therapeutics team is establishing selected models (e.g. NTG nitroglycerine-induced and inflammatory soup-induced migraine) in house. Once validated, these models could be used to provide more detailed assessment and provide extra supportive data for the targets of interest. In addition, these models will be used for combination assessment (Neurology Target Combinations) and mechanistic work as outlined in Figure 4.

c. Target Safety / Tolerability
1. Preliminary target safety assessment using in silico/literature review of target and known/predicted safety considerations
2. Cardiovascular safety, GI and tolerability studies (as needed) to better interpret efficacy studies

Deliverable: Selection of 1-3 prioritised programs [Validated Hit(s)] for progression to lead generation.", "": "" }, { "Text": "3. Hit ID
a) Computational Chemistry: Modelling of receptor structures

The receptor homology models will be evaluated, prioritised, challenged, and optimised in an iterative manner based on:
1. Their ability to rationalise and predict ligand SAR (e.g. explain importance of specific chemical groups, conformational properties, enable the discrimination of active/inactive molecules), and/or other pharmacological/biophysical experimental data (e.g. effects of mutations ligand binding/pharmacology should be consistent with the predicted ligand binding mode).
2. Their applicability for the prospective identification (virtual screening), structure-based design and optimisation of novel ligands

Models of the antagonist form of the receptor will be used to perform in silico screens of compound databases. Hits from screening will be docked into the models to help guide medicinal chemistry to elaborate hits. Sosei Heptares has developed and successfully applied combined energy-based and structural interaction fingerprint (IFP) scoring approaches for virtual GPCR ligands screening (de Graaf et al., Curr Opin Pharmacol, 30, 59 2016).

Molecular interaction field (GRID) and water interaction network (waterFLAP, waterMAP) based binding site analysis methods, Free Energy Perturbation (FEP+), and advanced MD methods/MetaMD have been developed at Sosei Heptares (in collaboration with Molecular Discovery and Schrodinger) to identify and prioritise druggable ligand binding (sub)pockets and guide structure-based ligand design (Mason et al. Tr Pharmacol Sci 2012, 33. Congreve et al. J Med Chem 2012, 55; Bortolato et al. J Chem Info Model 2013, 53).

Deliverable: including lead compounds bound consistent with known SAR,WaterMaps and MD trajectories.", "": "" }, { "Text": "b) Hit identification

Note that the description below applies to each of the selected receptor subtypes prioritised for resource commitment based on the outcome of target validation results, according to decisions made by the JSC.

The aim of the hit identification phase will be to use models and/or structural data of the selected targets from the TV activities to generate new chemical matter and to identify structurally distinct hit series with the potential for subtype selectivity. For each program (target / target profile), -risk off target associated toxicity. Sosei Heptares will evaluate hits in functional wild-type assay(s) and in binding assays (when available) outlined in Appendix A2.

1. Work-up and evaluation of current hits/tools reported from previous screening campaigns, utilising further compound design, synthesis and compound acquisition. 

Computational chemistry approaches, coupled with SDM, will provide information on likely binding site(s) and binding mode hypothesis to drive SAR optimisation and support hit confirmation via further file mining (internal and external) and/or early hit-to-lead chemistry. The ligands may act as an orthosteric antagonists or negative modulators that can be used to block the orthosteric agonist and facilitate the identification of other ligands targeting other orthosteric/allosteric binding pockets. Information from the binding modes of truncated and/or cyclic peptides may be particularly valuable to help hit ID strategy.", "": "" }, { "Text": "2. Scaffold hopping from existing compounds, using structural information / de novo design approaches from the refined model.

Validated ligand binding mode models in approach 1 (including from peptides) can serve as templates for ligand and structure-based hit ID approaches in addition to virtual screening inspired (approach 3) to identify new scaffolds/ligands targeting the same binding site. Furthermore, biophysical mapping and crystallographic data can be used to further refine the model and inspire further rounds of ideas.
Based on our relevant GPCR experience and in particular CGRP, privileged scaffold/pharmacophores have been identified for different orthosteric and allosteric Family B GPCR binding pockets (see approach 3) that can be used as an additional source for ligand design. For example, small (macrocyclic) peptide ligands based on class B GPCR experience may furthermore be used to derive additional SAR and/or starting points for such ligand design efforts for these targeted receptors (as noted earlier). in addition, work undertaken on SMEs to provide potential tools may lead to insights that could allow derivation on novel hit series, particularly once a binding mode / binding site has been characterised and would be an attractive option for commitment of chemical optimisation / SAR development.", "": "" }, { "Text": "3. Virtual screening based on the binding site(s) in an active (or inactive) state model of the receptor. 

Sosei Heptares will screen a database of commercially available compounds which are suitable starting points for drug discovery, selecting a subset of virtual hits for testing in assays. Complementary ligand-based and protein-based virtual screening approaches will be used including:
- Ligand-based approaches will include 2D fingerprint (e.g. ECFP with Arthor, GPUsim) and 3D shape/pharmacophore (e.g. ROCS, FLAP) similarity searches of large commercially available, in-house and/or virtual libraries against known ligand/pharmacophore references.
- Complementary ligand-based chemogenomics (ensemble) approaches (e.g. SEA, machine learning NB models) will be used to identify potential GPCR ligand repurposing opportunities.
- Based on Family B GPCR experience, agonist and antagonist conformation specific receptor-ligand interaction features have been identified in orthosteric and allosteric class B GPCR binding sites. These pharmacophoric features will be transformed into receptor customised protein structure-based and sequence-based virtual screening models (molecular docking, structural pharmacophore, interaction fingerprint-based models) to identify novel small molecule orthosteric antagonists. We may furthermore propose putative (cryptic) allosteric (in antagonist bound) homology models using customised binding site analysis approaches and exploit structural insights into different class B GPCR specific conformational changes associated with receptor activation states.

GPCR structure/sequence analysis based chemogenomics approaches facilitated by Sosei enabled GPCR structural databases combining public and proprietary GPCR structural information and bio/chemoinformatics tools (including ss-Tea, BioGPS, and customised GPCR structural cheminformatics workflows) will be used to identify potential GPCR ligand repurposing opportunities.", "": "" }, { "Text": "4. Screening of Sosei Heptares proprietary GPCR diversified libraries generated through a combination of chemoinformatic data mining and manual curation techniques

Customised screening libraries designed to cover the GPCRome to enable early hit identification and establish target tractability. These will be profiled in a developed wild-type receptor inhibitor assay in vitro and/or via SPR (when receptor inhibitor StaR is available). Combinations of complementary chemical libraries, carefully curated to balance appropriate physchem properties and prioritised based on pharmacophoric features of known ligands, binding sites and ligand binding mode hypotheses will be screened, including:
- chemogenomics library, enriched in chemical diversity across different GPCR modalities and binding sites (orthosteric, allosteric).
- Fragment libraries covering diverse pharmacophore and (3D) shape space and size, balancing different polar/ionic features compatible with anionic and cationic interaction sites in the receptor with sufficient lipophilicity essential to efficiently target druggable binding sites.  

Single concentration hits from any of the approaches outlined above will be confirmed by re-testing in the same assay by profiling in concentration response to generate a pIC50/pKi result and checked with orthogonal assays if feasible.", "": "" }, { "Text": "Additional Hit ID utilising StaR proteins

Note that the description below applies to each of the selected receptor subtypes prioritised for resource commitment according to decisions made by the JSC.

The aim of this phase will be to use receptor StaR protein to generate new chemical matter via enablement of the following potential approaches:

1. StaR protein will be characterised to confirm retainment of inhibitor binding to support hit identification using the thermostabilised receptor. Stabilised receptor will be purified in detergent to provide soluble protein and enable the potential application of DNA-encoded library screening. Receptor affinity binders identified as specific for the antagonist conformation of the receptor against a negative control will be synthesised off DNA and pharmacologically characterised in both functional and binding assays outlined in Appendix A1.

2. Fragment screening will be employed when a suitable biophysical assay format has been established for the receptor using a focused fragment library. Based on experience of Family B targets we might expect acidic fragments (which are well represented in the Heptares fragment library) to bind different orthosteric and allosteric binding sites (possibly facilitated with e.g. the identified DEL ligand). Comparative fragment-based chemogenomics analysis of hit sets (using previous fragment screening data against other GPCR targets) will allow hit prioritisation and definition of initial fragment binding site/mode analysis.

fails to deliver a completed Stabilized Receptor (StaR) which is subsequently demonstrated to enable compound screening in e.g. SPR or DNA-encoded library platforms as described", "": "" }, { "Text": "Stage II (Hit ID) Deliverable: Identification of target potency <10uM in an overexpressing cell line and less than 3x standard deviation of vehicle control in parental cell line (consistent with the criteria in Appendix A2). Chemical series as defined in this", "": "" }, { "Text": "Figure 4: Decision Tree for Prioritisation of AM/AMY/PACAP Target Group(s) Through Target Validation to declare Selected Neurology Target(s):

Goal is to identify optimum profile within each target group", "": "" }, { "Text": "Required Activities for Selected Neurology Targets

The activities and criteria listed below and depicted in Figure 4 will serve as the completion criteria for stage I & II and mark the end of initial target validation to enable progression to Lead Gen Completion of initial target validation for each Neurology Target shall mean that:  
 Target expression confirmed in TG (RNA, protein; rat & human) implications of species/splice specific considerations understood
 The screening funnel to support lead generation activities has been established.
o Validated in vitro assays in place, in vivo plans in place
o Tool molecules (literature, in house peptidic tools) characterized (criteria in appendix A1).
 Druggability is established: 
o StaR activities; suitable for structure-based drug design
o Hit ID activities leading to tseries completed to initiate Lead Gen efforts
 Selected models evaluated for utility (receptor expression, protocols estd, positive controls etc.)
 In vivo activity alone or in combination with other target group members in AM/AMY/PACAP Target group (using either literature or in-house tools) is established.
o Efficacy in a model of migraine determined in a dose-response manner
o Supplemental vasodilation / other pharmacodynamic models including involvement of central vs peripheral mechanisms in the efficacy profile.
 Potential target specific safety / toxicity liabilities plans established (in vitro or in vivo study) to de-risk target and increase likelihood of adequate therapeutic index.", "": "" }, { "Text": "A Selected Neurology Target will be nominated for each AM/AMY/PACAP Target group amongst the Neurology Target(s) and Neurology Target Combinations completing Criteria For Selected Neurology Targets listed above.  

Summary plan for stage I & II:

8 Neurology Targets assessed structurally, through target validation and safety assessment resulting in up to 3 Neurology Programs entering into stage III that satisfies the Completion Criteria above and after review by the JGC.", "": "" }, { "Text": "Stage III: Drug Discovery 

Figure 5: GANTT for Stage 3 for selected PACAP program", "": "" }, { "Text": "Figure 6: GANTT for Stage 3 for additional programs 2 & 3", "": "" }, { "Text": "a) Lead Generation 

Note that the description below applies to each of the selected receptor subtypes prioritised for resource commitment according to decisions made by the JGC.

Aim: To identify lead candidates from 2 distinct chemical series and demonstrate in vitro and acute in vivo activity 
 To identify potent inhibitors of receptor using SAR/SBDD medicinal chemistry efforts
 To evaluate ADME/PK properties of selected hits
 To demonstrate efficacy in an in vivo model of migraine with proprietary compound(s)

Once hits are confirmed and concentration response curves obtained, the most promising examples for further elaboration will be selected based on several factors, including molecular efficiencies, synthetic tractability, confidence in modelled binding modes, and prioritising chemotypes based on developability. 

Complementary 2D/topology based (fast GPU similarity, orthogonal molecular fingerprints) and 3D based similarity search methods (shape/pharmacophore search, protein docking-structural interaction fingerprint scoring protocols) against purchasable, synthesisable (e.g. Enamine REAL), and de novo virtual library design approaches are available for hit elaboration. Small library designs will be structural ligand binding mode hypothesis driven (including established SAR, SDM, binding mode/chemogenomics analysis) and will use appropriate molecule generation approaches (e.g. R-group, molecular matched pair analysis/machine learning driven, in-house MedChem Ideas generator tool) and scoring functions (ligand/structure-based, multi-property Pareto scoring).

Complementary medicinal chemistry ligand design strategies will be used in conjunction with above hit elaboration approaches, including structure-based bio-isosteric replacement strategies based on comparative analyses of combined public and in-house GPCR structures and models. Physiochemical property assessment in combination with early in vitro ADME and in vivo PK of hit series will also be used to prioritise chemotypes with the highest potential to deliver suitable orally active profiles.", "": "" }, { "Text": "Binding poses for key molecules will be obtained from docking into models, enhanced with Biophysical Mapping data if feasible, or, if possible, from X-ray structures. Molecule design will be part guided by docking poses, and part empirically to build up SAR of the series. As more SAR is established, and confidence increases in the binding poses, compound optimisation will become more structure-based. Physicochemical property assessments will also guide medicinal chemistry design (in combination with SBDD) and will be further utilised to measure molecular efficiencies and ADME endpoints to guide further design iterations. Medicinal chemistry for these activities may be resourced at Sosei Heptares or at one of the service providers used by Sosei Heptares. GPCR customised binding site analysis approaches and advanced biomolecular simulation methods (see Hit Identification section) are available to guide structure-based ligand design efforts. 

Experimentally enhanced receptor models accommodating different orthosteric and allosteric ligand binding sites and agonist/antagonist conformations are available based on public and proprietary insights into class B GPCR structure, biophysical (e.g. HDX), and pharmacological (mutation mapping) data. Insights into Family B GPCR structure-activity/selectivity relationships provide a framework for efficient receptor focused ligand library design. 

The in vitro pharmacology of compounds will be tested in primary functional assays to determine potency/efficacy and competition binding if available for affinity measurements. Activity at orthologue receptors will also be examined to understand cross species activity in addition to other off-target GPCR selectivity assessment.  

Molecules with appropriate pharmacology and in vitro ADME properties will be selected for rodent PK profiling to establish IV Cl correlation and oral bioavailability determination. Molecules with sufficient free exposure cover over primary pharmacology will be further selected as tools for in vivo efficacy profiling to aid target validation and establish PK/PD relationship.", "": "" }, { "Text": "(Lead Generation) Deliverable: To identify lead molecules from two (2) prioritised and distinct chemical series with appropriate pharmacology, ADME, PK and in vivo acute PK/PD consistent with the criteria in Appendix B. Translational biomarker strategy will be generated to outline clinically feasible biomarker assays. Strategy will contain assays in order to provide early proof of pharmacology (i.e. receptor occupancy or receptor signalling induction) and proof of biology (i.e. gene signature, cytokine modulation, or cellular composition/activation).", "": "" }, { "Text": "b) Lead optimisation

Note that the description below applies to each of the selected receptor subtypes prioritised for resource commitment according to decisions made by the JSC. For the avoidance of doubt this would likely be one, two or three LO campaigns (either single target, or target profile of > 1 target) in total, selected from a total of 8 targets evaluated under this research plan. 

Aim: To optimize candidates from two (2) distinct chemical series and demonstrate in vivo activity in a relevant chronic disease model(s) and acceptable safety profile
 To demonstrate efficacy in appropriate in vivo disease model(s) chemical series", "": "" }, { "Text": "The prioritised and elaborated two (2) lead chemical series will be subjected to further optimisation. Both binding affinity and functional activity of compounds will be monitored, with the emphasis on relevant assay(s) that correlate to PK/PD understanding. Parameters such as residence time on the receptor may also be monitored if considered to be important. In addition to functional activity at the human receptor, activity at orthologue receptors (e.g. rat, dog) will be closely monitored as all necessary orthologue assays become available. Furthermore, assessment of compound potency on a target relevant cell-based assay endogenously expressing the receptor via access to existing network of Sosei Heptares collaborators will be included. 

At this stage, it is anticipated that X-ray structures with compounds bound will be available to guide the design of compounds for synthesis. Well-established medicinal chemistry considerations will be used to ensure good developability properties of compounds, consistent with oral delivery. Physiochemical property consideration will play a key factor in the molecule design process to ensure compound profiles are suitably aligned to the desired target product profile. Molecular efficiencies will be closely monitored and used to assess progress and molecule selection for key studies. Medicinal chemistry will be resourced at Sosei Heptares or at one of the service providers used by Sosei Heptares.", "": "" }, { "Text": "The DMPK properties of promising compounds will be continually measured and optimised to support further progression toward Candidate Selection. Properties such as solubility, lipophilicity, metabolic stability, clearance, volume of distribution and brain penetration will be measured at Sosei Heptares CROs. Advanced leads will be selected for second species PK profiling to build confidence in human PK predictions and rodent toxicokinetic studies to assess exposures upon repeat dosing.

The front-runner molecules from each chemical series will be tested in relevant in vitro and in vivo studies to confirm target engagement (biomarker), drug distribution profile and efficacy in in vivo animal model studies. Studies and endpoints will be aligned to an agreed Target Product Profile and will form key components to guide the human dose selection for FTIM studies. As stated in the Introduction, the overarching goal is to identify whether the selected profile has the potential for (i) higher efficacy levels compared to stand of care and/or (ii) higher response rates compared to standard of care.  

a) In vitro evaluation
 Confirm pharmacology in relevant human cell / tissue-based assays and demonstrate evidence of in vitro target engagement and pathway modulation. 
 Identify target-engagement biomarkers (e.g. gene transcription / phosphorylation profiles) suitable for future clinical validation/development. It is envisaged that biomarker development and validation work will progress beyond the end of candidate selection. Biomarkers may be anticipated to be reproducible, dose-dependent, and have both temporal and spatial sensitivity.

b) In vivo evaluation
The in vivo strategy will be planned/agreed jointly by AbbVie and Sosei Heptares and ratified by the JGC. 
 Confirm distribution of drug to the target site of action. 
 Confirm PD activity and efficacy of lead molecule(s) in a relevant acute/ subchronic in vivo migraine model(s).  
 Demonstrate in vivo target engagement / modulation of pathway specific biomarkers as needed.
 Determine a PK:PD relationship between unbound and/or bound drug concentrations at the target and/or plasma/whole blood and relevant acute/sub-acute/chronic efficacy endpoints to support human dose predictions.
 Develop a PB:PK model to support human PK prediction.
 Determine brain to plasma distribution, as appropriate.", "": "" }, { "Text": "The preferred compounds will undergo additional in vitro and in vivo toxicological profiling

1. In vitro safety assessment
 The lead molecules will be evaluated in assays to assess hERG inhibition and other off-target pharmacology, HepG2 cytotoxicity and mitotoxicity (Glu/Gal), BSEP inhibition, 5-strain AMES and in vitro micronucleus (Sosei Heptares).

2. In vivo safety 
 In vivo safety will be assessed in rodent and non-rodent MTD studies to understand acute tolerability and high dose TK (Sosei Heptares). The non-rodent MTD species selection will incorporate cross-species pharmacology and metabolic profiling data (Sosei Heptares). Endpoints relevant to the endogenous ligand/receptor will be evaluated (e.g., lung, stomach, spleen, brainstem, hypothalamus for AMY receptors). 

3. Mechanistic safety
 An assessment of mechanistic safety will be undertaken (Sosei Heptares) and any proposed de-risking studies will be performed (Sosei Heptares) as agreed by JGC.", "": "" }, { "Text": "CMC 
1. Fit-for-purpose route selection/development will be conducted at Sosei Heptares to provide a batch to support pre-clinical studies including high dose oral PK studies, additional mechanistic safety/PD studies and solid form characterisation. 
2. Initial solid form characterisation (XRPD, TGA, DSC, DVS, microscopy), biopharmaceutics screening (to include biorelevant solubility and chemical stability) as well as preclinical formulation development (for early in-vivo and toxicology studies) will be conducted on this batch (Sosei Heptares).

(Lead Optimization) Deliverable: Prioritised 2-4 optimised leads from each of two (2) distinct chemical series (for clarity, each chemical series to produce 2-4 optimised lead molecules) fulfilling the desired in vitro pharmacology, target engagement in relevant human cell/tissue assays, in vivo efficacy, DMPK and safety profile (consistent with Appendix C) as mutually agreed by the JGC during the research phase and approved by AbbVie internal governance processes. Optimization of additional compounds from each chemical series will be done in parallel with the goal of identifying additional chemical matter fulfilling criteria outlined in Appendix C. In this stage, initiation of proof of concept experiments demonstrating the correlation of translational biomarkers with PK and efficacy in animal models will occur. Proof of concept experiments in human model systems/primary cells (in vitro/ex vivo systems) will also be conducted to demonstrate human translatability of biomarkers. In addition, PKPD modelling and human dose prediction will be performed and intermediate API provision to support high dose oral PK studies and further translational/safety studies will be generated.", "": "" }, { "Text": "Preclinical Development 

Note that the description below applies to each of the selected receptor subtypes prioritised for resource commitment according to decisions made by the JSC. For the avoidance of doubt, this would likely be one, two or three campaigns in total, selected from a total of 8 targets evaluated under this research plan.", "": "" }, { "Text": "c) Candidate Nomination to Candidate Selection

Aim: To further optimize and select a minimum of 2 candidates in total (at any given time) to take through to candidate nomination phase and which would be suitable for advancement into preclinical development; likely that a frontrunner from one series and a back-up from a distinct chemical series would initially be prioritised from the Stage 3 deliverables compound set 
 To generate PK and PKPD data and interpretation supporting optimum therapeutic profile. 
 To evaluate cardiovascular safety and secondary pharmacodynamics studies in the context of predicted human efficacy and PKPD. 
 To identify and select the most promising lead candidates for GLP-toxicology studies.

Lead molecules (Stage 3 Deliverables) from each chemical series will be tested in relevant in vitro and in vivo studies outlined below to support candidate nomination and candidate selection (Appendix C & D). It is expected that these studies will continue post-candidate selection to support PKPD and human dose predictions for regulatory submission. Final candidate selection compound from each series will ultimately be decided by AbbVie.", "": "" }, { "Text": "Conduct mechanistic PK and metabolism studies as needed, as described in Appendix D, to support 1) toxicology evaluation(s) such as potential of metabolite(s) to induce toxicity, 2) to support refinement of human PK predictions including comparison of primary metabolic pathways and kinetics in animals and human in vitro and 3) determine major metabolising enzymes and/or transporters contributing to clearance and DDI potential of each candidate as perpetrator and victim.  
 A salt screen (if appropriate) and polymorph screen will typically be carried out prior to manufacture of the non-GMP batch to support GLP tox studies. This non-GMP batch will also support initial ICH stability studies, and formulation development activities including Tech batch stability. Details of the CMC deliverables are described in Appendix G.", "": "" }, { "Text": "Provision of non-GMP material for 2 species DRF will be coordinated by Sosei Heptares. Both AbbVie and Sosei Heptares will contribute to the CMC strategy of DRF bulk delivery and enabling GMP manufacture, and strategy will be mutually agreed / ratified by the JGC (Appendix F). 

Final agreement for the GMP API manufacture, as well as the GMP API and DP CROs, will be mutually agreed / ratified by the JGC. It is expected that these activities will be initiated following Candidate Nomination and following provision of non-GMP material for the DRF and GLP studies. 

In parallel with detailed preclinical candidate selection studies with the most advanced current leads from each chemical series, a backup program will identify additional candidate quality molecules for each chemical series, if required. Detailed profiling of existing advanced ligands in combination with new molecule designs will be prosecuted to ensure suitable back-up options are identified that are differentiated from the most advanced lead molecule. The selection of the back-up compound by AbbVie will be focused on de-risking the liabilities confirmed to be associated with the lead compound but not limited to structural diversity, toxicity profile, ADME/ DDI potential.", "": "" }, { "Text": "(Preclinical Candidate Selection) Deliverables: 

 Two chemically differentiated compounds (one from each chemical series) selected fulfilling criteria outlined in Appendix D including rodent and non-rodent 14d DRF and dog CV molecule with acceptable safety profiles and defined therapeutic margins to progress to pre-FTIH GLP toxicology studies (Sosei Heptares).
 Understanding of potential on-target safety risks (Sosei Heptares).
 Full translational biomarker packages (discovered in Stage 3: Lead Optimization) will be generated for lead candidates (Sosei Heptares). Delivery of candidate pharmacodynamic biomarkers with pre-clinical validation and evidence to support clinical proof of mechanism/pharmacology studies (expectation that these will require further validation in preparation for use in early clinical studies that will be performed as part of the Pre-Clinical Development and Phase1 Set Up phases of the program)
 Non-GMP API provision for 2 species DRF studies to support further progression of candidates (Sosei Heptares).", "": "" }, { "Text": "d) Candidate Selection to IND

1. GLP toxicology studies in rodent and non-rodent
Following selection of a leading candidate at Candidate Selection, planning for rodent and non-rodent GLP toxicology studies will be initiated and conducted (Appendices D&H). It is anticipated that a 1-month GLP toxicology study will be the default duration of study. However, if AbbVie decides a 3-month duration is needed in one or both of the toxicology species, then this study plan will be developed. Safety pharmacology and non-clinical toxicological studies will be managed by Sosei Heptares related to running specialised in vitro studies as outlined below. All activities will be agreed in collaboration between both parties, in accordance with the regulatory requirements of AbbVie and with JGC ratification. Development and validation of GLP bioanalytical methods will be undertaken for detection of parent compound in plasma as default; need for parent compound detection in another matrix and/or detection of circulating metabolite to be ratified by joint decision via the JGC.", "": "" }, { "Text": "2. Provision of IND-ready package
Preparation of the IND-ready package will be the responsibility of Sosei Heptares to include: 1) transfer of data in suitable format including SEND-ready format for GLP toxicology and toxicokinetic data; 2) provision of study reports for GLP Toxicology, Toxicokinetics, Pharmacology/Safety Pharmacology, DMPK and CMC (Drug Substance and Drug Product) as outlined in Appendix F.", "": "" }, { "Text": "3. Non-GMP and GMP material synthesis
Following selection of a leading candidate and the duration of GLP toxicology study at Candidate Selection, manufacture of sufficient non-GMP material will be initiated along with supporting studies on stability, impurity profile, etc as described in Appendix E&F. (Sosei-Heptares)

Suitable formulation will be developed for GLP toxicology studies. (Sosei-Heptares)

If needed, synthesis of metabolite standards will be conducted for detection of metabolite(s) in GLP toxicology studies and, if appropriate, in clinical studies. (Sosei-Heptares)

If needed, synthesis of radiolabelled material (14C or 3H) will be conducted to support mechanistic ADME-Tox studies pre-FTIH. The requirement for this, or otherwise, will be ratified at the JGC. (Sosei-Heptares)

Subsequently GMP material will be manufactured to support Phase 1 studies with supporting studies as described in Appendix E&F. (Sosei-Heptares)", "": "" }, { "Text": "To support the wide dose range typically studied in the first time in human single ascending dose study, a simple oral dosing suspension/solution or powder in capsule formulation will likely be used dependent upon emergent information about systemic absorption from the upper small intestine and safety margins from systemic toxicity/tolerance. 

Deliverables:
 FTIH enabling GLP toxicology package in rodent and non-rodent species as outlined in Appendix D (Sosei Heptares).
 Development and validation of GLP bioanalytical methods for detection of parent compound in plasma as default; need for parent compound detection in another matrix and/or detection of circulating metabolite(s) to be ratified by joint agreement at the JGC (Sosei Heptares).
 Manufacture of sufficient non-GMP and GMP material, as described in Appendix E (Sosei Heptares).", "": "" }, { "Text": "e) Phase 1 Set Up 

Preparation for FTIH study will be managed by Sosei Heptares and AbbVie as outlined below:

1. Bioanalytical Method and Pharmacodynamic Biomarkers
Development and validation of bioanalytical methods for use in the FTIH study are the responsibility of AbbVie. Development of potential pharmacodynamic markers with relevant pre-clinical validation for use in the FTIH study are the responsibility of Sosei Heptares (see also deliverables in pre-clinical candidate selection section). Clinical validation of PD biomarkers will be the responsibility of AbbVie.", "": "" }, { "Text": "2. General Investigational Plan and FTIH study 
The Target Product Profile and General Investigational Plan to deliver on the profile are the responsibility of AbbVie. Details will be shared through the JGC.  
After opt-in by AbbVie, AbbVie will be responsible for design and conduct of the FTIH study.

3. Preparation for submission of IND/CTA 
After opt-in by AbbVie, AbbVie will be responsible for submission of an IND or CTA for the FTIH study.

Stage III research plan:
Deliverable up to 3 selective pharmacological candidates IND ready", "": "" }, { "Text": "Appendix A. Hit Identification & Target Validation Criteria (For Stage I & II)

The activities and criteria listed below in Appendix A1 and A2 will serve as the completion criteria for stage I & II and mark the end of initial target validation to enable progression to Lead Generation.", "": "" }, { "Text": "Appendix A1. Criteria for Selected Neurology Target

A Selected Neurology Target will be nominated for each AM/AMY/PACAP Target group amongst the Neurology Target(s) and Neurology Target Combinations completing Criteria For Selected Neurology Targets listed below.", "": "" }, { "Text": "Activity / Assay Criteria Comments
Project enablement
Target Expression Target expression confirmed in TG (RNA, protein; rat & human) -Implications of species/splice-specific considerations understood


Selected models evaluated for utility (receptor expression, protocols and positive controls are established.) - Required


Guidelines only
Screening funnel to support lead generation in place - Validated in vitro assays

Tool molecules (literature and in house peptidic tools) characterised - Required

STAR activities Suitable for structure-based drug design - Required 
Tool criteria for in vitro and in vivo target validation
Goal: To enable in vitro and in vivo target validation

Peptide tool suitable for in vitro validation 
Receptor Potency IC50 <100nM - Required
Orthologue Potency <10 fold difference c.f. human - Required
Off target activity at the remaining 7 receptors - 30 fold selectivity - Required

Tool suitable for in vivo validation criteria as above plus:
In vivo pharmacokinetics Exposure should enable coverage of target upon dosing at pharmacologically acceptable doses (up to 100mg/kg) for 2 hours. - Required

Target Validation as depicted in Figure 4
In vitro target validation covered in stage 1 above Efficacy in model systems defined in target validation / MoA section (Stage 1. Section 4) - Target Selectivity understood


In vivo validation; covered in stage 1 and 2 above - Demonstrate efficacy in a relevant model of migraine e.g. NTG or inflammatory soup-induced migraine model, as appropriate). [Understand dose-response relationship and central vs peripheral effects.] 

In vivo activity alone or in combination with other target group members in AM/AMY/PACAP Target group (using literature tools and /or peptidic tools Heptares generated) is established - Required

Understand potential target specific safety / toxicity liabilities plans established (in vitro or in vivo study) to de-risk target and increase likelihood of adequate therapeutic index

Supplemental vasodilation / other pharmacodynamic models - Supplemental", "": "" }, { "Text": "Appendix A2. Criteria for Validated Hit 

Activity / Assay Criteria Comments
Chemistry
Goal: Hit ID activities completed to initiate Lead Gen efforts

Chemical Series Chemical structures that are synthetically tractable for further SAR exploration. - Required

Structure Activity Relationships Evidence of SAR based on hit confirmation work (file mining &/or wet work) - Required

SBDD Binding mode established from structural work or binding hypothesis from homology models to guide future chemistry campaign - Established

Physicochemical Properties MW <600
 clogP <5
TPSA 40-140 - Guidelines only

Intellectual Property No insurmountable issues with prior art searches based on Markush searches on each chemotype - Required

Pharmacology & Biophysics
On Target GPCR Small molecule 
potency (IC50) <10 uM 

- Required

Neurology Designated Pharmacology for Neurology Targets are antagonist, inverse agonist or negative allosteric modulator.

Off Target effects





Specificity confirmed in parental cell assays; less than 3x standard deviation vehicle control, up to 10uM tested; no cytotoxicity at IC50 concentration 

CGRP counterscreen 10-fold difference; CGRP means the calcitonin gene related peptide receptor, also the complex of CLR (calcitonin receptor-like receptor) and RAMP1 (receptor activity modifying protein 1).


- Required

Target Validation as depicted in Figure 4 (in the case of skipping Target Validation in A1) 
In vitro target validation covered in stage 1 above Efficacy in model systems defined in target validation / MoA section (Stage 1. Section 4) - Target Selectivity understood


In vivo validation; covered in stage 1 and 2 above - Demonstrate efficacy in a relevant model of migraine e.g. NTG or inflammatory soup-induced migraine model, as appropriate). [Understand dose-response relationship and central vs peripheral effects.] 

In vivo activity alone or in combination with other target group members in AM/AMY/PACAP Target group (using literature tools and /or peptidic tools Heptares generated) is established - Required

Understand potential target specific safety / toxicity liabilities and establish plans to de-risk target and increase likelihood of adequate therapeutic index

Supplemental vasodilation / other pharmacodynamic models - Supplemental", "": "" }, { "Text": "Appendix B: Lead Generation Criteria

Activity / Assay Criteria Comments
Chemical Series and SAR  
Chemical Series Lead compounds in each series that are distinct based on shape, lipophilicity and electrostatics. - Required

Structure Activity Relationships Interpretable across 2-3 log potency range against other GPCR - Understood in context of molecular modelling or structural data 

Structural Biology Established, or proximal - As required to advance the med-chem program

Physicochemical Properties MW <600 
 Measured logD 1.5-3.5 
 clogP<5
 tPSA 70-140
Kinetic solubility (>50uM) (Stock solution DMSO followed by dilution in PBS or water) - Guidelines only
Operating in property space that increases the likelihood of achieving favourable oral PK attributes in humans is preferred to avoid significant timeline slippage. Rationale should be provided to support operating in non-traditional property space Heptares will also generate chromlogD on every molecule and use this to rate efficiency (e.g. LLE)

Intellectual Property No insurmountable issues with prior art searches based on Markush searches on each chemotype - Required
Liaison with AbbVie IP attorneys to align on searches and conclusions

In Vitro  
Target GPCR <100nM & <10-fold shift in cross species - Human required, cross species desirable

Off Target GPCR >100x selective versus other GPCR or - Data to be generated and flags understood / considered tractable to optimisation

Binding assays Binding (via StaR or radioligand assay) and function measurable and correlation established - target engagement demonstrated - Required

Cell based assays Based on the selected GPCR relevant cell type - Required

In vitro ADME  
r/mu/hu microsomal &/or hepatocyte stability Clp,u assessed and starting to build an understanding of the IVIVc - Data to be generated and flags understood / considered tractable to optimisation

CYP Inhibition Panel CYP inhibition assessed and starting to build an understanding of DDI risk - Data to be generated and flags understood / considered tractable to optimisation

Thermodynamic Solubility (pH 7.4) Solubility risk assessment for projected clinically relevant doses conducted and any flags raised. High dose rodent PK to assess exposure cover in tox studies (as appropriate) - Data to be generated and flags understood / considered tractable to optimisation

Cellular Permeability Assess Papp and determine efflux properties - Data to be generated and flags understood / considered tractable to optimisation

In Vivo Pharmacokinetics 
Rodent PK In vivo rodent PK of selected analogs: including brain to plasma distribution and oral bioavailability ( 10%) - Exposure should enable coverage of target upon oral dosing at pharmacologically acceptable doses. 

In vitro Safety Pharmacology  
hERG IC50 >100x primary pharmacology in patch clamp - Data to be generated and flags understood / considered tractable to optimisation

In Vivo Efficacy  
Acute / Sub-chronic efficacy
Rodent PK/PD relationship Target occupancy sustained sufficiently to deliver desired pharmacological response in in vivo models via any route of administration. Interpretable occupancy-exposure relationship. - Required", "": "" }, { "Text": "Appendix C: Candidate Nomination Criteria

Activity / Assay Criteria Comments
All of the requirements of Stage 2
In vitro/in vivo
 
 
Acute and chronic model in vivo efficacy  

Efficacy ED50 <10mg/kg in model defined in target validation / MoA section. Dose responsive with understanding of target occupancy (PK-PD) - Data to be generated and understood, and drug series considered tractable to optimisation in mouse or rat as PK properties dictate.  

Translational Biomarkers  
Proof of Pharmacology Demonstrate a dose dependent induction of biomarkers with in vivo animal systems that tracks with PK. Demonstrate the ability to induce the biomarker in in vitro human correlate. - Assays need to be clinically feasible. Examples of clinically feasible assays consist of interrogation of serum, plasma, whole blood or feces. When aligned with clinical design may also include tissue biopsies.

Proof of Biology Demonstrate dose dependent induction of biomarkers that tracks with efficacy in animal models. Demonstrate same proof of biology biomarkers in human systems or using cyno in vivo models if appropriate. - Assays need to be clinically feasible. Examples of clinically feasible assays consist of interrogation of serum, plasma, whole blood or feces. When aligned with clinical design may also include tissue biopsies.

PK and Pharmaceutics  
Physicochemical Properties MW <500
 Measured logD 1.5-3.5
 clogP<5
 tPSA 70-120
 Kinetic solubility >100 M (Stock solution DMSO followed by dilution in PBS or water) - Guidelines only
Operating in property space that increases the likelihood of achieving favorable oral PK attributes in humans is preferred to avoid significant timeline slippage. Rationale should be provided to support operating in non-traditional property space. Heptares will also generate chromlogD on every molecule and use this to rate efficiency (e.g. LLE)

Intellectual Property No insurmountable issues with prior art searches based on Markush searches on each chemotype - Required
Liaison with AbbVie IP attorneys to align on searches and conclusions

r/mu/hu microsomal stability > 70% parent at 25 mins - Required

CYP Inhibition Panel IC50 >10 M versus 2D6, 3A4, 2C9, 2C19, 1A2
SimCYP modelling if outside desired criteria demonstrating no DDI risk - Data to be generated and understood, series considered tractable to optimisation 


Cellular Permeability Papp >10 x 10-6 cm/sec; no efflux issues as judged by AB/BA ratio; not a PGP substrate (unless designing for peripheral restriction) - Guideline only
Data to be generated and understood, series considered tractable to optimisation 

Rodent PK In vivo rodent PK of selected analogs: including brain to plasma levels, oral bioavailability (>30%); Clp < 1L/hr/kg; t1/2 > 2.5hrs; low-medium Vss 

PK commensurate with required human dose prediction using allometric scaling. If rodent specific route of clearance then adequate exposure in efficacy and safety studies. - Exposure should enable coverage of target upon oral dosing at pharmacologically acceptable doses defined as target coverage over IC50 or EC50 (inhibitor or agonist)
Propose pre-clinical PK is used to guide efficacy and safety doses and human PK predictions. Rigid cut offs may be too stringent many known drugs have rat Clp>20 mL/min/Kg", "": "" }, { "Text": "Escalating dose rodent PK Understanding of Cmax, AUC dose response; exposure at higher doses to support design of rodent tox species; achieve multiples of efficacious AUC consistent with at least 30X therapeutic index - Data to be generated and understood, series considered tractable to optimisation 


Non-rodent PK In vivo PK of selected analogs: oral bioavailability >30%; Clp < 1L/hr/kg; t1/2 > 2.5hrs; low-medium Vss

PK commensurate with required human dose prediction using allometric scaling. If 2nd sp. specific route of clearance, then adequate exposure in efficacy and safety studies. - Data to be generated and understood, series considered tractable to optimisation 
Pre-clinical PK is used to guide efficacy and safety doses and human PK predictions. Rigid cut offs should not be applied 


CYP phenotyping and induction and possible need to detect non-CYP metabolism and/or active transport Determine which CYP(s) are responsible for metabolism; assess potential for CYP induction - Data to be generated and understood, series considered tractable to optimisation 


Human PK predictions QD or BID (minimally); F >30% - Data to be generated and understood, series considered tractable to optimisation 


Solubility, LogD Any risks at clinically relevant doses discharged & clear path forward for exposure cover in tox studies - Data to be generated and understood, series considered tractable to optimisation 


 

Safety Pharmacology and Toxicology
hERG IC50 >1000x primary pharmacology in patch clamp - Data to be generated and understood, series considered tractable to optimisation 


Rat CV >30X window between projected human efficacious Cmax and any hemodynamic effect in rat - Data to be generated and understood, series considered tractable to optimisation 


Receptor selectivity panel (eg CEREP) No insurmountable issues - Data to be generated and understood, series considered tractable to optimisation

Mini AMES Negative (+/- S9) - Required

Micronucleus Negative - Required

Rodent 7- day toxicity (dose range finding) NOAEL (at least) 30x exposures multiple between predicted human efficacious AUC and adverse event. Plasma exposures. Endpoints include a) clinical observations (b) body weight (c) food consumption (d) gross necropsy observations (e) organ weights (f) hematology (g) serum chemistry (h) histopathology - Required.
Conduct 7 day early toxicity study in rodent at this stage (often 1 sex only, broad dosage range) to get a sense of the high dosage toxicity liabilities.  

Bulk Drug Synthesis and Formulation See CMC appendix E", "": "" }, { "Text": "Appendix D: Candidate Selection & GLP Toxicology Criteria 


 Activity / Assay Criteria Comments
Stage 4a Prior to Candidate Selection :- All of the requirements of Stage 3 plus:
Dog CV and Secondary pharmacodynamics >30X window between projected human efficacious unbound Cmax and any hemodynamic effect in dog (perform one study to GLP standards) - Data interpretable and support progression

In vitro ADME study in microsomes and hepatocytes Determine in vitro biotransformation primary pathway of metabolism to inform IVIVE of clearance and inform choice of tox species; use radiolabel if available - Data interpretable and support progression

De-risk circulating metabolites identified for either pharmacological activity and/or bioactivation Where circulating metabolite(s) suspected from PK, PKPD and/or Tox studies, conduct follow-up studies for relevance to human regarding potential pharmacological activity or bioactivation potential. Use in vitro systems with human-relevant translation and/or in vivo animal data to understand concentration-effect relationship
- Study conducted if a specific requirement identified  


Rodent and non-rodent 14 day dose range finding toxicity study) NOAEL of at least 30x exposures multiple between predicted human efficacious AUC and the exposure at the NOAEL dosage. Endpoints will include clinical observations, body weight, food consumption, gross necropsy observations, organ weights, hematology, serum chemistry, histopathology. JGC to review dosages, exposures achieved, toxicity characterization, declaration of the NOAEL and multiple of the exposure seen at the NOAEL dosage and the predicted human efficacious exposure. AbbVie to decide whether GLP toxicity studies should be 4 weeks duration of dosing or a longer period such as 13 weeks. - Required
If the NOAEL is based on a toxicity liability that is known to increase in severity with increasing duration of dosing, or is known to be seen at lower exposures with increased duration of dosing, then longer duration of dosing IND-enabling GLP toxicology studies (13 weeks) should be conducted to fully appreciate the toxicity liability of the molecule prior to the decision to submit an IND. EG: hepatobiliary toxicity generally increases in severity with increasing duration of dosing, and is seen at lower exposures with increasing duration of dosing. Conducting 13-week toxicity studies will increase the understanding of the NOAEL exposure with clinically relevant (PoC) duration of dosing.  


PK and metabolism Conduct in vitro and in vivo metabolism studies using radiolabel compound. 
Identify metabolites
Complete analysis of PK parameter (half-life, %F, clearance, volume of distribution, Cmax, AUC) across species (eg rodents, dog, monkeys) iv and oral administration
Based on a compilation of the above data sets, further refine human predictions of PK profile that would enable BID/QD dosing - Data interpretable and support progression






.", "": "" }, { "Text": "Determine that interaction with major CYP isoforms and transporters; assess the probability of drug-drug interaction liabilities (CYP victim, CYP inhibition inhibition/ induction, transporters)
Stage 4b Post Candidate Selection :- All of the requirements of Stage 3 and 4a plus:
GLP bioanalytical assay Development and validation of GLP bioanalytical method for detection of parent compound in plasma as default for both rodent and non-rodent tox species; need for parent compound detection in other matrix and/or detection of circulating metabolite to be ratified by joint JSC - Provision of analytical standards for parent compound, internal standard and possibly metabolite(s) needed

GLP toxicology studies Criteria for success would include successful generation of a NOAEL exposure (compared to the predicted human efficacious exposure) at least a) 30x for 4-week toxicology study or b)15x for 13-week toxicology study. NOAEL optimally based on a toxicity finding that can be detected with a readily available biomarker (eg. Clinical Chemistry, Hematology) which has been shown to increase/decrease prior to the onset of irreversible histologic alterations. Endpoints will include clinical observations, body weight, food consumption, gross necropsy observations, organ weights, hematology, serum chemistry, histopathology. Findings from these studies should show absence of any significant findings precluding compound progression to FTIH studies - Required

Bulk Drug Synthesis and Formulation See CMC appendix E", "": "" }, { "Text": "Appendix E: CMC Workplan (at time of initiation of collaboration)

Sosei Heptares/AbbVie CMC Workplan
(Pre-IND Activities/Deliverables)
Deliverable Responsible Party
Pre-OPT-IN Activity Description (Heptares or AbbVie)
 
Stage 3 Support 
 Drug substance solid form selection/characterization, including assessment of salts, solubility, crystallinity, polymorphism) and make an initial recommendation on preferred API form, - Heptares

 Assess thermal and oxidative stability in solid and solution state - Heptares

 Assessment from AbbVie process chemistry group on tractability of medicinal chemistry route - AbbVie

 AbbVie will collaborate to complete advanced pharmaceutics characterization preclinical candidate salt form selection, stability (chemical, light, solution etc), excipient compatibility, solid state characteristics, formulation, impurity profile, formulation for DRF and GLP tox - AbbVie

 Manufacture of drug substance for PK - Heptares
Stage 4a support 
AbbVie will collaborate to complete salt form selection - AbbVie
 Develop enabling chemistry and synthetic process - Heptares
 Manufacture of drug substance for DRF Tox studies and formulation development - Heptares
 Drug substance analytical release testing - Heptares

Stage 4b support 
 AbbVie will collaborate to complete, stability (chemical, light, solution etc) excipient compatibility, solid state characteristics, formulation, impurity profile, formulation plans for FTIH studies - Abbvie

 Manufacture of drug substance for GLP Tox, - Heptares
 Drug substance analytical release testing - Heptares
 Synthesis of metabolite standards as needed for de-risking circulating metabolites - Heptares
 Synthesis of 14C and/or 3H radiolabel as needed for ADME-Tox investigation - Heptares
Produce and characterize stable label internal standard (SLIS) - Heptares
 Select and manage drug substance CDMOs (SM, DS, Analytical) - Heptares/AbbVie (JGC)
1. Develop/Validate drug substance analytical methods (SM, INT, IPC, final API) - Heptares
 Mutagenic assessment of the DS synthesis and appropriate control strategy - Heptares
 Produce and characterize a suitable reference standard - Heptares
 Manufacture of GMP drug substance for Phase 1 clinical supplies - Heptares
 Quality release of drug substance against established specifications - Heptares
 Drug substance stability program under typical ICH storage conditions - Heptares
 Select and manage drug product CDMOs (DP, Pkg, Analytical) - Heptares/AbbVie (JGC)
 Develop Phase 1 clinical formulation - Heptares
 Drug product excipient compatibility/stress degradation assessment - Heptares
 Develop pilot-scale drug product manufacturing process - Heptares
2. Develop/Validate drug product analytical methods for Phase1 formulation - Heptares
 Manufacture/Packaging of GMP Phase 1 clinical supplies - Heptares
 Quality release of drug product against established specifications - Heptares
 Drug product stability program under typical ICH storage conditions - Heptares
", "": "" }, { "Text": "Deliverable
Responsible Party
OPT-IN Activity Description (Heptares or AbbVie)
Documentation of drug substance and drug product development in respective development reports [identification, structural confirmation, process development, analytical development, control strategy, reference standard, stability] - Heptares

Transfer DS/DP analytical methods by:
 Providing written methods for all analytical release and stability assays for non-USP methods which support regulatory filings
 Formal transfer methods of product specific methods are required
Provide consultation to answer questions regarding analytic methods - Heptares

Setup contracts with DS/DP CDMOs conducting stability studies to transfer control of studies to AbbVie - AbbVie

Continue to provide storage of DS/DP GMP stability samples and regulatory retains or coordinate transfer to site determined by AbbVie - Heptares

Provide DS/DP release and stability testing of new GMP/clinical lots until transfer of stability studies is complete - Heptares

Assume control and costs for DS/DP stability studies and storage of materials - AbbVie

Heptares DS/DP materials to be shipped to site TBD by AbbVie at the completion of tech transfer, except for materials needed to complete tech transfer, such as reference standards:
 List materials
 DS/DP inventory (SM, INT, DS, DP) 
 Reference standards
Samples in support of tech transfer or manufacturing 
Note: Inventory may remain at current suppliers until contracts with AbbVie are in place. Material requests will be facilitated by the Heptares team. - Heptares

Provide DS/DP reports which support technology transfer including:
 developmental history reports
 technical development reports
 Executed batch records
 
 Reports that support CMC section of the IND/CTD 
 GMP CDMO audit reports and quality agreements - Heptares

Provide documentation/communications with Regulatory Agencies - Heptares
DS/DP Tech transfer Process
 Coordinate 3-way CDAs with mfg. vendors
 Setup F2F meetings at mfg. sites
 - Heptares

", "": "" }, { "Text": "Appendix F: Stage 4a&b - CMC & Toxicology Workflow", "": "" }, { "Text": "Appendix G: Nonclinical and CMC reports and documents to be included for an IND submission

Nonclinical reports for an IND (small molecule) should cover, but not limited to, the following topics:

Pharmacology

 Primary Pharmacology: in vitro, in vivo

 Secondary Pharmacology: off target binding assays for receptors, ion channels, enzymes and transporters

Safety Pharmacology: CV (hERG, in vivo), CNS, respiratory

Pharmacokinetics

 Bioanalytical method validation

 Absorption: cellular permeability, pharmacokinetics in nonclinical species, dose response, formulation effects (if necessary)

 Distribution: protein binding across species and concentration, red blood cell distribution, tissue distribution (optional)

 Metabolism: in vitro stability in liver microsomes/hepatocytes across species, CYP phenotyping, metabolite ID with proposed biotransformation pathway, in vivo metabolite profiles

 Excretion: definition of major clearance routes

 Drug-Drug Interaction Potential: CYP inhibition (including TDI), CYP induction, interactions with transporters (inhibitor, substrate)

 Human pharmacokinetics predictions, including DDI potential at projected efficacious exposures

Toxicology

 Single dose toxicity (optional)

 Repeat dose toxicity in rodent and non-rodent

 Genotoxicity package: In vitro mutagenicity, in vitro chromosomal aberration, in vivo micronucleus


CMC reports and documents for an IND (small molecule) should cover, but not limited to, the following topics:", "": "" }, { "Text": "CMC
Drug Substance 

 Properties of the drug substance: Optical Isomerism, Physical State/Description, Melting Point, pKa, Solubility (specify conditions - temp./pH), Hygroscopicity, Polymorphism 

 Names and addresses of sites performing drug substance manufacture and testing (release and stability)

 Drug substance batch records which should include any testing done in-process and at intermediates; ChemDraw file of synthetic scheme for GMP steps

 Any reports or batch records for manufacture of starting materials and CoAs for the starting materials (these are informational only)

 Documentation on how the GLP tox batch was manufactured (e.g., synthetic scheme or development report) so that a high-level comparison can be made with the GMP batch

Confirmation of structure: Information associated with Mass Spec, IR, NMR (H1 and C13), X-Ray, UV (including specta)

 PGI assessment reports; Summaries of control strategies for Class 1-2 impurities from starting materials and GMP synthesis steps; Option 4 control strategies for Class 1-2 impurities; structures of any identified drug substance impurities if different from those specified in the drug substance

 Specifications

 Methods

 Validation information - acceptance criteria, results, chromatgram overlays, linearity plots

 CoAs / results for clinical and non-clinical lots

 Justification for each specification

 Reference Standard CoA or summary of results

 If details are not provided in the batch records, documentation describing all components of the drug substance package

 Stability Protocol(s) and details of study (e.g. packaging used for stability samples); Stability Data

 
Drug Product

 

 List of all of the excipients used in the manufacture of the drug product; include quality of standard (e.g. USP/JP/Ph. Eu.), function and amount", "": "" }, { "Text": "High level description of the manufacturing process.

 Names and addresses of sites performing drug product manufacture and testing (release and stability)

 Excipient amounts for an exemplary batch of drug product

 Detailed description of each step in the manufacturing process (including a flow diagram); diagram should include material inputs, process steps and process controls

 A list of all the critical steps in the manufacturing process

 Specification for each non-compendial excipient, if applicable.

 Methods for evaluating each non-compendial excipient, if applicable

Method validation for each method for non-compendial excipient, if applicable

 CoA for non-compendial excipient, if applicable

 Attestation that there are not excipients of human or animal origin

 Listing of any novel excipients

 Drug Product Specifications

 Drug Product Methods

 Validation information - acceptance criteria, results, chromatogram overlays, linearity plots

 CoAs / results for clinical and non-clinical lots

 Characterization of impurities that are unique to the drug product; under what conditions are they formed

 Justification for each specification

 Reference Standard CoA or summary of results

 If details are not provided in the batch records, documentation describing all components of the drug product package

 Stability Protocol(s) and details of study (e.g. packaging used for stability samples); Stability Data", "": "" }, { "Text": "APPENDIX H: Literature tools

PACAP Receptor Target Group Literature Tools: 

Below are examples of tool compounds identified from the literature: 


 PAC-1 
o PA-8 small molecule for PAC-1 (Takasaki et al., 2018); IC50 in cAMP assay: 2 nM
o Reduced inflammatory pain in mice (Takasaki et al., 2019)


 VPAC-1 
o PG97-269 (low nM; >2000-fold selectivity vs. VPAC-2 & PAC-1)
 Reduced PACAP-38 or VIP vasodilation (Boni et al., 2009; Baun et al., 2011; Chan et al., 2010)
 VPAC-2 
o PG99-465 (2 nM; partial agonist at VPAC-1 with 100-fold selectivity)
 Reduced vasodilation by VIP (Erdling et al., 2013; Baun et al., 2011) 


 Non-selective VPAC-1 & VPAC-2: VIP 6-28
o rKi = 11 nM/96 nM for VPAC1/2; 62-545-fold selectivity vs. PAC1
o Reduced pain readouts in OA models (McDougall et al., 2006; Schuelert and McDougall, 2006)
o Reduced PACAP-27 or VIP vasodilation (Erdling et al., 2013; Chan et al., 2011)


 Non-selective VPAC-2 & PAC-1: PACAP 6-38
o PAC1 30nM; VPAC-2 40nM; VPAC-1 600 nM
o Intrathecally reduced inflammatory/neuropathic allodynia (Davis-Taber et al., 2008) 
o Both peptide antagonists have evidence for partial agonism see Saghy et al., 2015", "": "" }, { "Text": "AMY Receptor Target Group Literature Tools: 

AMY1 and AMY3 have several nonselective peptide antagonists (AC187; salmon CT8-32; human alphaCGRP8-37). No known AMY2 tool compounds are available. 


 AC187 
 Commercially available 
 IC50 = 0.48 nM; displays 38-fold and 400-fold selectivity over calcitonin and CGRP receptors respectively. 
 Amylin and AC187 in rat pain model: Amylin s.c. administration 20min prior to a formalin-induced pain model. Bidirectional stimulation by Amylin vs. antagonist AC187. Whereas CGRP receptor antagonist did not act at these same spinal circuits. (Potes et al., 2016)


 Salmon CT8-32 
 In mouse pain model: / Bidirectional nociceptive or antinociceptive effects of amylin in the acetic acid-induced writhing test. Pretreatment of mice with CT8-32 either i.p. or i.t. antagonized effect of amylin. (Huang et al., 2010)", "": "" }, { "Text": "AM Receptor Target Group Literature Tools: 

AM target group have several non-selective peptide antagonists (AM1, AM2 & CGRP). No known selective AM tool compounds are available. Some of the promising non-selective tool compounds are: 
 AM-22-52 
 Compound 8 (dual CGRP/AM2 antagonist)
 AM neutralizing ligand Ab (Enibarcimab by Adrenomed AG-Ph3 and others CT-M & CT-H listed in Struck et al., 2013) 




", "": "" }, { "Text": "Appendix I. LIST OF CROs (in addition to those outlined in schedule 3.2.3 of existing agreement)


Company Location Support
Melior Discovery Exton PA, USA In vivo models
Charles River Wilmington, MA, USA In vivo models
Neurosolutions Warwick, UK In vitro models
Anabios San Diego, CA, USA Human In vitro models
Precision Medicine Royston, UK Human distribution
StembanCC Oxford, UK iPSC trigeminal neurones
BioAscent Motherwell, UK Compound management / compound screening
Sygnature Discovery Nottingham, IK Primary screening", "": "" }, { "Text": "138468604_13", "": "" }, { "Text": "ESCROW AGREEMENT", "": "" }, { "Text": "THIS ESCROW AGREEMENT (this \"Agreement\") is entered into as of October 4, 2023, by and among Mitokinin, Inc., (the \"Company\"), Shareholder Representative Services LLC, solely in its capacity as representative of the Indemnifying Stockholders (\"Representative\", and together with the Company, sometimes referred to individually as \"Party\" and collectively as the \"Parties\"), and JPMorgan Chase Bank, N.A. (\"Escrow Agent\").", "": "" }, { "Text": "WHEREAS, Sapphire Merger Sub, Inc. (\"Purchaser\"), the Company and Abbvie Inc. have entered into an Agreement to Purchase Class H Common Stock and Warrant to Purchase Class H Common Stock, dated February 25, 2021 (the \"Warrant\");", "": "" }, { "Text": "WHEREAS, capitalized terms used but not otherwise defined herein shall have the meanings ascribed to such terms in the Warrant; provided, however, that Escrow Agent shall not be responsible for determining the meaning of any capitalized term not entirely defined herein;", "": "" }, { "Text": "WHEREAS, the Warrant provides for the appointment by the Parties of an escrow agent to receive, hold and distribute the Escrow Deposit (as such term is hereafter defined); and", "": "" }, { "Text": "WHEREAS, the Parties desire to appoint Escrow Agent to serve as Escrow Agent, and Escrow Agent desires to agree to such appointment pursuant to the terms and conditions set forth in this Agreement.", "": "" }, { "Text": "WHEREAS, simultaneously with the execution of this Agreement, the Company, the Representative and JPMorgan Chase Bank, N.A., in its capacity as paying agent (the \"Paying Agent\"), have entered into that certain Paying Agent Agreement pursuant to which the Paying Agent has established an account for the purpose of receiving funds disbursed pursuant to this Agreement.", "": "" }, { "Text": "NOW, THEREFORE, in consideration of the promises and agreements contained herein and other good and valuable considerations, the receipt and sufficiency of which are hereby acknowledged, the Parties and the Escrow Agent, intending to be legally bound, hereby agree as follows:", "": "" }, { "Text": "1. Appointment. The Parties hereby appoint Escrow Agent to serve as escrow agent for the purposes set forth herein, and Escrow Agent hereby accepts such appointment under the terms and conditions set forth herein.", "": "" }, { "Text": "2. Fund; Investment.", "": "" }, { "Text": "(a) Pursuant to Section 2.7(b)(ii) of the Warrant, on the date hereof, promptly following receipt by the Company of the Warrant Exercise Payment, the Company shall deposit, in the demand deposit account designated by Escrow Agent (the \"Escrow Account\"), by wire transfer of immediately available funds, the sum of Eleven Million U.S. Dollars ($11,000,000) (the \"Escrow Deposit\") to be held in escrow in accordance with the terms of this Agreement. Escrow Agent shall hold the Escrow Deposit in the Escrow Account and shall invest and reinvest the Escrow Deposit and all interest or other income thereof (the \"Fund\") in a Money Market Deposit Account (\"MMDA\"), or a successor investment offered by Escrow Agent. MMDA have rates of compensation that may vary from time to time as determined by Escrow Agent. No other investment of the Escrow Deposit will be permitted during the term of this Agreement.", "": "" }, { "Text": "(b) Escrow Agent will not provide supervision, recommendations or advice relating to either the investment of moneys held in the Escrow Account or the purchase, sale, retention or other disposition of any investment described herein, and each Party acknowledges that it was not offered any investment, tax or accounting advice or recommendation by Escrow Agent with regard to any investment and has made an independent assessment of the suitability and appropriateness of any investment selected hereunder for purposes of this Agreement. Escrow Agent shall not have any liability for any loss sustained as a result of any investment made pursuant to the terms of this Agreement or as a result of any liquidation of any investment prior to its maturity or for the failure of an Authorized Representative of the Parties to give Escrow Agent instructions to invest or reinvest the Fund. Escrow Agent shall have the right to liquidate any investments held in order to provide funds necessary to make required payments under this Agreement.", "": "" }, { "Text": "(c) All interest or other income earned under this Agreement shall be allocated to the Company and reported, by Escrow Agent to the IRS, or any other taxing authority, on IRS Form 1099 or 1042/1042-S (or other appropriate form) as income earned from the Escrow Deposit by the Company whether or not said income has been distributed during such year. Escrow Agent shall withhold any taxes it deems appropriate in the absence of proper tax documentation or as required by law, and shall remit such taxes to the appropriate authorities. The Company hereby represents to Escrow Agent that no other tax withholding or information reporting of any kind is required by Escrow Agent.", "": "" }, { "Text": "3. Disposition of Fund.", "": "" }, { "Text": "(a) Escrow Agent shall release the Fund within (i) three (3) Business Days following its receipt of and in accordance with joint written instructions executed by an Authorized Representative (as defined below) of each Party in substantially the form of Exhibit A annexed hereto (\"Joint Written Instructions\") or (ii) within five (5) Business Days following receipt of a final, non-appealable court order or determination by a court of competent jurisdiction or an arbitrator directing the release of all or a portion of the Fund together with (A) a written certification from counsel for the instructing Party attesting that such order or determination is final and not subject to further proceedings or appeal and from a court of competent jurisdiction (as applicable) along with (B) a written instruction from an Authorized Representative of the instructing Party given to effectuate such order or determination (collectively, a \"Final Determination\"). Escrow Agent shall review the Final Determination to which such certification and instruction refers, shall be entitled to rely upon any such certification and instruction and shall have no responsibility to review the order or determination or to make any determination as to whether such order or determination is final, not appealable and from a court of competent jurisdiction (as applicable). Notwithstanding anything to the contrary, any Joint Written Instructions or Final Determination in any way related to the transfer or distribution of the Fund must, in order to be deemed delivered and effective, be in writing and executed by the appropriate Party or Parties as evidenced by the signatures of the person or persons signing this Agreement or one of the designated persons as set forth on the Designation of Authorized Representatives attached hereto as Schedule 1-A and 1-B (each an \"Authorized Representative\"), and delivered to Escrow Agent only as a Portable Document Format (\"PDF\") attached to an email only at the email address set forth in Section 8 below or through an online platform offered by Escrow Agent's escrow services business. Escrow Agent shall not be liable to any Party or other person for refraining from acting upon any instruction for or related to the transfer or distribution of the Fund that does not satisfy the requirements herein. Escrow Agent may rely and act in good faith upon the confirmation of anyone purporting to be an Authorized Representative in connection with any of Escrow Agent's verifying callbacks or email confirmations. Notwithstanding anything to the contrary, the Parties acknowledge and agree that Escrow Agent (i) shall have no obligation to take any action in connection with this Agreement on a non-Business Day and any action Escrow Agent may otherwise be required to perform on a non-Business Day may be performed by Escrow Agent on the following Business Day and (ii) may not transfer or distribute the Fund until Escrow Agent has completed its security procedures.", "": "" }, { "Text": "(b) Negative Post-Closing Adjustment. In accordance with Section 3(b)(iv)(B) of the Equityholder Representation and Indemnity Agreement dated on or around the date hereof by and between the Company and Representative (the \"ERIA\"), within ten (10) Business Days following the final determination of the Post-Closing Adjustment in accordance with the terms of the Warrant, if the Post-Closing Adjustment is a negative amount, then each of the Company and Representative will execute Joint Written Instructions to Escrow Agent instructing Escrow Agent to disburse to the Company (or the Company's designee) an amount in cash equal to the absolute value of the Post-Closing Adjustment, and within three (3) Business Days following the receipt by Escrow Agent of such Joint Written Instructions, Escrow Agent will pay that amount (or, if the funds in the Escrow Account are insufficient to satisfy the payment of such Post-Closing Adjustment in full, the remainder of the funds in the Escrow Account) to the Company (or the Company's designee), by wire transfer of immediately available funds, out of the Escrow Account.", "": "" }, { "Text": "(c) Indemnification Escrow Payment – Initial Release Date. In accordance with Section 3(c)(i) of the ERIA, on or prior to the eighteen (18) month anniversary of the date hereof (the \"Initial Escrow Release Date\"), the Company and Representative will provide Joint Written Instructions to Escrow Agent instructing Escrow Agent to release a payment (which the Parties agree, as between themselves, will be an Indemnification Escrow Payment as defined in the ERIA) from the Fund to the Paying Agent for the benefit of the Indemnifying Stockholders in an amount calculated by the Parties to be equal to (i) $11,000,000, minus (ii) the aggregate amount paid from the Fund to the Company Indemnified Parties prior to the Initial Escrow Release Date, minus (iii) the aggregate amount set forth in (1) all Claim Notices that are pending resolution pursuant to Section 6 of the Warrant and (2) notices relating to Tax Claims pursuant to Section 7(d) of the Warrant (\"Pending Claim Amount\") as of the Initial Escrow Release Date, minus (iv) $4,000,000; provided, that if the amount resulting from clauses (i)-(iv) would result in a negative number, no amount shall be directed by the Parties to be released from the Fund pursuant to this Section 3(c).", "": "" }, { "Text": "(d) Indemnification Escrow Payment – Subsequent Release Date. In accordance with Section 3(c)(ii) of the ERIA, on or prior to the thirty-six (36) month anniversary of the date hereof (the \"Subsequent Escrow Release Date\"), the Company and Representative will provide Joint Written Instruction to Escrow Agent instructing Escrow Agent to release a payment (which the Parties agree, as between themselves, will be an Indemnification Escrow Payment) from the Fund to the Paying Agent for the benefit of the Indemnifying Stockholders in an amount calculated by the Parties to be equal to (A) the amount then remaining in the Fund minus (B) the Pending Claim Amount as of the Subsequent Escrow Release Date.", "": "" }, { "Text": "(e) Each Party authorizes Escrow Agent to use the funds transfer instructions (\"Standing Instructions\") specified for it in Schedule 3 attached hereto (as may be supplemented from time to time as described below) to disburse any funds due to such Party, without a verifying callback or email confirmation as set forth below.", "": "" }, { "Text": "(f) If any funds transfer instructions other than Standing Instructions are set forth in a permitted instruction from a Party or the Parties in accordance with this Agreement, Escrow Agent may confirm such funds transfer instructions by a telephone callback or email confirmation to an Authorized Representative of such Party or Parties and thereafter, such funds transfer instructions shall also be considered the applicable Party's Standing Instructions hereunder. To the extent a callback or email confirmation is undertaken, no funds will be disbursed until such confirmation occurs. If multiple disbursements are provided for under this Agreement pursuant to any Standing Instructions, only the date, amount and/or description of payments may change without requiring a telephone callback or email confirmation.", "": "" }, { "Text": "(g) The persons designated as Authorized Representatives and telephone numbers and email addresses for same may be changed only in a writing executed by an Authorized Representative or other duly authorized person of the applicable Party setting forth such changes and actually received by Escrow Agent via facsimile or as a PDF attached to an email or through an online platform offered by Escrow Agent's escrow services business. Escrow Agent may confirm any such change in Authorized Representatives by a telephone callback or email confirmation according to its security procedures.", "": "" }, { "Text": "(h) Escrow Agent and other financial institutions, including any intermediary bank and the beneficiary's bank, may rely upon the identifying number of the beneficiary, the beneficiary's bank or any intermediary bank included in a funds transfer instruction, even if it identifies a person different from the beneficiary, the beneficiary's bank or intermediary bank identified by name. It is understood that the purpose of Escrow Agent's security procedures is to verify the authenticity of, and not to detect errors in, instructions.", "": "" }, { "Text": "(e) As used in this Agreement, \"Business Day\" shall mean a day other than a Saturday, Sunday or other day on which Escrow Agent located at the notice address set forth below is authorized or required by law to close. The Parties acknowledge that the security procedures set forth in this Section 3 are commercially reasonable.", "": "" }, { "Text": "4. Escrow Agent. Escrow Agent shall have only those duties as are specifically and expressly provided herein, which shall be deemed purely ministerial in nature, and no other duties, including but not limited to any fiduciary duty, shall be implied. Notwithstanding anything to the contrary contained herein, Escrow Agent has no knowledge of, nor any obligation to comply with, the terms and conditions of any other agreement, including between the Parties, Escrow Agent shall not be responsible for determining the meaning of any capitalized term not entirely defined herein, nor shall Escrow Agent be required to determine if any Party has complied with any other agreement. Notwithstanding the terms of any other agreement, the terms and conditions of this Agreement shall control the actions of Escrow Agent. Escrow Agent may conclusively rely upon any written notice, document, instruction or request delivered by the Parties believed in good faith by it to be genuine and to have been signed by an Authorized Representative(s), as applicable, without inquiry and without requiring substantiating evidence of any kind and Escrow Agent shall be under no duty to inquire into or investigate the validity, accuracy or content of any such document, notice, instruction or request. Any notice, document, instruction or request delivered by a Party but not required or contemplated under this Agreement may be disregarded by Escrow Agent. ESCROW AGENT SHALL NOT BE LIABLE FOR ANY ACTION TAKEN, SUFFERED OR OMITTED TO BE TAKEN BY IT IN GOOD FAITH EXCEPT TO THE EXTENT THAT DIRECT DAMAGES TO A PARTY RESULT FROM ESCROW AGENT'S BAD FAITH, GROSS NEGLIGENCE, FRAUD, WILLFUL MISCONDUCT OR MATERIAL VIOLATION OF ANY FEDERAL OR STATE LAW. Escrow Agent may execute any of its powers and perform any of its duties hereunder directly or through affiliates or agents. In the event that Escrow Agent shall be uncertain, or believes there is some ambiguity, as to its duties or rights hereunder or receives instructions, claims or demands from any Party hereto which in Escrow Agent's judgment conflict with the provisions of this Agreement, or if Escrow Agent receives conflicting instructions from the Parties, Escrow Agent shall be entitled to either (a) refrain from taking any action, and its sole obligation shall be to keep safely all property held in deposit, until it shall be given (i) a joint written direction executed by Authorized Representatives of the Parties which eliminates such ambiguity or conflict or (ii) a Final Determination or (b) file an action in interpleader. Escrow Agent shall have no duty to solicit any payments which may be due it or any accounts governed by this Agreement, including, without limitation, the Escrow Deposit nor shall Escrow Agent have any duty or obligation to confirm or verify the accuracy or correctness of any amounts deposited with it hereunder. The Parties grant to Escrow Agent a lien and security interest in the Fund in order to secure any indemnification obligations of the Parties or obligation for fees or expenses owed to Escrow Agent hereunder. NOTWITHSTANDING ANYTHING IN THIS AGREEMENT TO THE CONTRARY, IN NO EVENT SHALL ESCROW AGENT BE LIABLE FOR SPECIAL, INCIDENTAL, PUNITIVE, INDIRECT OR CONSEQUENTIAL LOSS OR DAMAGE OF ANY KIND WHATSOEVER (INCLUDING BUT NOT LIMITED TO LOST PROFITS), EVEN IF ESCROW AGENT HAS BEEN ADVISED OF THE LIKELIHOOD OF SUCH LOSS OR DAMAGE AND REGARDLESS OF THE FORM OF ACTION.", "": "" }, { "Text": "5. Succession. Escrow Agent may resign and be discharged from its duties or obligations hereunder by giving no less than sixty (60) days advance notice in writing of such resignation to the Parties or may be removed, with or without cause, by the Parties at any time after giving not less than sixty (60) days advance joint written notice to Escrow Agent executed by an Authorized Representative of each Party. Such resignation or removal shall take effect upon the appointment of a successor escrow agent by the Parties. Escrow Agent's sole responsibility after such sixty (60) day notice period expires shall be to hold the Fund (without any obligation to reinvest the same) and to deliver the same to a designated substitute escrow agent, if any, appointed by the Parties, or such other person designated by the Parties, or in accordance with the directions of a final court order, at which time of delivery, Escrow Agent's obligations hereunder shall cease and terminate; provided, that Escrow Agent shall not be discharged from any liability as described in Section 4 for actions taken as Escrow Agent under this Agreement prior to such succession. Escrow Agent shall provide all assistance to the successor agent to ensure that such transition is handled in a non-disruptive manner. If prior to the effective resignation or removal date, the Parties have failed to appoint a successor escrow agent, or to instruct Escrow Agent to deliver the Fund to another person as provided above, or if such delivery is contrary to applicable law, at any time on or after the effective resignation date, Escrow Agent may either (a) interplead the Fund with a court located in the State of Delaware and the costs, expenses and reasonable attorney's fees which are incurred in connection with such proceeding may be charged against and withdrawn from the Fund, or (b) appoint a successor escrow agent of its own choice. Any appointment of a successor escrow agent shall be binding upon the Parties and no appointed successor escrow agent shall be deemed to be an agent of Escrow Agent. Escrow Agent shall deliver the Fund to any appointed successor escrow agent, at which time Escrow Agent's obligations under this Agreement shall cease and terminate. Any entity into which Escrow Agent may be merged or converted or with which it may be consolidated, or any entity to which all or substantially all the escrow business may be transferred, shall be Escrow Agent under this Agreement without further act.", "": "" }, { "Text": "6. Compensation; Acknowledgment. The Parties agree jointly and severally to pay Escrow Agent upon execution of this Agreement and from time to time thereafter reasonable compensation for the services to be rendered hereunder, which unless otherwise agreed in writing, shall be as described in Schedule 2. The Parties agree that, notwithstanding anything to the contrary, to the extent any Party deposits such compensation into an account governed by this Agreement, Escrow Agent shall have the right to withdraw such compensation from such account. Each of the Parties further agrees to the disclosures and agreements set forth in Schedule 2. The Company and Representative agree that irrespective of any joint and several liability that either may have to Escrow Agent under this Agreement, as between them, the Company and Representative (on behalf of the Indemnifying Stockholders) will each only be liable for 50% of any compensation owed to Escrow Agent under this Section 6. As between the Company and Representative, if either the Company or Representative (on behalf of the Indemnifying Stockholders) incurs greater than 50% of any such compensation, the Company or Representative (on behalf of the Indemnifying Stockholders), as applicable, will promptly make payment to the other Party such that each of the Company and Representative (on behalf of the Indemnifying Stockholders) has borne 50% of all amounts which are due to Agent under this Section 6.", "": "" }, { "Text": "7. Indemnification and Reimbursement. The Parties agree jointly and severally to indemnify, defend, hold harmless, pay or reimburse Escrow Agent and its affiliates and their respective successors, assigns, directors, agents and employees (the \"Indemnitees\") from and against any and all losses, damages, claims, liabilities, taxes (other than taxes on income earned by Indemnitee in connection herewith) and reasonable and documented costs or expenses (including attorney's fees) (collectively \"Losses\"), arising out of or in connection with (directly or indirectly) (a) Escrow Agent's good faith performance of its obligations under this Agreement, except to the extent that such Losses are finally determined by a court of competent jurisdiction to have been caused by the fraud, gross negligence, willful misconduct, or bad faith of such Indemnitee; and (b) Escrow Agent's following, accepting or acting upon any instructions or directions, whether joint or singular, from the Parties received in accordance with this Agreement. For the avoidance of doubt, it is understood and agreed that the intent of the clause \"solely in its capacity as representative of the Indemnifying Stockholders\" in this Agreement, is to clarify that the Company and Indemnifying Stockholders are the parties with economic interests in the Warrant, and the Indemnifying Stockholders shall ultimately be responsible to the Representative for any indemnification obligations or liabilities that the Representative has to the Escrow Agent hereunder. Accordingly, such clause clarifies the Representative's recourse to the Indemnifying Stockholders and are not meant to limit the Representative's capacity or liability as between itself and the Escrow Agent under the Indemnity in this Section 7 or under any other provision in this Agreement. The Parties hereby grant Escrow Agent a right of set-off against the Fund for the payment of any claim for indemnification, fees, expenses and amounts due to Escrow Agent or an Indemnity. If any such action, claim, suit, demand or proceeding shall be brought or asserted against any Indemnitee, Escrow Agent shall promptly notify the Company and Representative in writing, after receipt of which notice each of the Company or Representative may participate in the Indemnitee's defense thereof and shall have the discretion to approve any settlement offers prior to Indemnitee's acceptance of such offer (which shall not be unreasonably withheld, conditioned or delayed). The obligations set forth in this Section 7 shall survive the resignation, replacement or removal of Escrow Agent or the termination of this Agreement. As between the Parties, the Company and Representative agree that irrespective of any joint and several liability that any obligation for indemnification shall be borne by the Party (and in the case of Representative, on behalf of the Indemnifying Stockholders) determined by a court of competent jurisdiction to be responsible for causing the Losses against which the Indemnitees are entitled to indemnification or, if no such determination is made, the Company and Representative (on behalf of the Indemnifying Stockholders) will each be liable for no more than 50% of any Losses incurred by Escrow Agent and the Indemnitees which result in reimbursement or indemnification under this Section 7. As between the Parties, if either the Company or Representative (on behalf of the Indemnifying Stockholders) incurs greater than 50% of any such Losses, the Company or Representative (on behalf of the Indemnifying Stockholders), as applicable, will promptly make payment to the other Party such that each of the Company and Representative (on behalf of the Indemnifying Stockholders) has borne 50% of all amounts which are due to the Indemnitees under this Section 7.", "": "" }, { "Text": "8. Notices. Except as otherwise provided in Section 3, all communications hereunder shall be in writing (which may be a PDF attached to an email) and shall be delivered by email or overnight courier only to the appropriate email address or notice address set forth for each party as follows:", "": "" }, { "Text": "If to Company: Mitokinin, Inc. c/o AbbVie Inc. Dept. V312, Bldg. AP34 1 North Waukegan Rd. North Chicago, IL 60064 Attention: Treasury Ops, Wayne Klintworth, VP, Assistant Treasurer wayne.klintworth@abbvie.com  and treasury.support@abbvie.com", "": "" }, { "Text": "and", "": "" }, { "Text": "AbbVie Inc. Dept. V312, Bldg. AP34 1 North Waukegan Rd. North Chicago, IL 60064 Attention: Vice Chairman, External Affairs, Chief Legal Officer, and Corporate Secretary Facsimile: 847-935-3294", "": "" }, { "Text": "with a copy (which will not constitute notice) to:", "": "" }, { "Text": "Ropes & Gray LLP Prudential Tower 800 Boylston Street Boston, MA 02199-3600 Attention: Marc Rubenstein and Michael Connolly E mail: marc.rubenstein@ropesgray.com  and michael.connolly@ropesgray.com", "": "" }, { "Text": "If to Representative: Shareholder Representative Services LLC 950 17th Street, Suite 1400 Denver, CO 80202 Attention: Managing Director Email: deals@srsacquiom.com", "": "" }, { "Text": "with a copy (which will not constitute notice) to:", "": "" }, { "Text": "Goodwin Procter LLP 100 Northern Avenue Boston, MA 02110 Attention: Eric Carlson E mail: ecarlson@goodwinlaw.com", "": "" }, { "Text": "If to Escrow Agent: JPMorgan Chase Bank, N.A. Escrow Services 10 South Dearborn Street; Mail Code IL1-0113 Chicago, IL 60603 Attention: Cindy Reis Fax No.: (312) 954-0430 Email Address: mw.escrow@jpmorgan.com", "": "" }, { "Text": "Any Party and Escrow Agent may change the address to which notices are to be delivered by giving the Escrow Agent and the other Party, as applicable, notice in the manner provided in this Section 8. Notwithstanding the above and except as set forth in Section 3, in the case of communications delivered to the Escrow Agent pursuant to this Section 8, such written communication must be executed by an Authorized Representative of the applicable Party and delivered to the Escrow Agent and the other Party.", "": "" }, { "Text": "9. Compliance with Directives. In the event that a legal garnishment, attachment, levy, restraining notice, court order or other governmental order (a \"Directive\") is served with respect to any of the Fund, or the delivery thereof shall be stayed or enjoined by a Directive, Escrow Agent is hereby expressly authorized, in its sole discretion, to obey and comply with all such Directives so entered or issued, and in the event that Escrow Agent obeys or complies with any such Directive it shall not be liable to any of the Parties hereto or to any other person by reason of such compliance notwithstanding such Directive be subsequently reversed, modified, annulled, set aside or vacated.", "": "" }, { "Text": "10. Termination of Agreement. This Agreement may be terminated by the written agreement of the Parties and Escrow Agent and shall automatically terminate upon delivery of the Fund in full by Escrow Agent, and all the related account(s) shall be closed subject to the provisions of Sections 6 and 7.", "": "" }, { "Text": "11. Miscellaneous.", "": "" }, { "Text": "(a) The provisions of this Agreement may be waived, altered, amended or supplemented only by a writing signed by Escrow Agent and the Parties (or their respective successors in interest, if applicable). Neither this Agreement nor any right or interest hereunder may be assigned in whole or in part by any Party hereto without the prior consent of Escrow Agent and the other Party and any assignment in violation of this Agreement shall be ineffective and void and of no effect ab initio. This Agreement shall be governed by and construed under the laws of the State of Delaware without giving effect to any principles of conflicts or choice of law that may result in the application of the laws of another jurisdiction. Each Party and Escrow Agent irrevocably waives any objection on the grounds of venue, forum non-conveniens or any similar grounds and irrevocably consents to service of process by mail or in any other manner permitted by applicable law and consents to the jurisdiction of the courts located in the State of Delaware. To the extent that in any jurisdiction either Party may now or hereafter be entitled to claim for itself or its assets, immunity from suit, execution, attachment (before or after judgment) or other legal process or immunity from liability, such Party shall not claim, and hereby irrevocably waives, such immunity. Escrow Agent and the Parties further hereby knowingly, voluntarily and intentionally irrevocably waive, to the fullest extent permitted by applicable law, any right to a trial by jury with respect to any lawsuit or judicial proceeding arising or relating to this Agreement. Escrow Agent hereby agrees with each of the Parties that it shall perform all of its obligations under this Agreement and shall not deliver custody or possession of any of the Fund to any except pursuant to the express terms of this Agreement or as otherwise required by applicable law. Following the date hereof, each Party shall deliver to the other Party such further information and documents and shall execute and deliver to the other Party such further instruments and agreement as any other Party shall reasonably request to consummate or confirm the transactions provided for herein, to accomplish the purpose hereof or to assure any other Party the benefits hereof.", "": "" }, { "Text": "(b) No party to this Agreement shall be liable to any other party for losses due to, or if it is unable to perform its obligations under the terms of this Agreement because of, acts of God, fire, war, terrorism, floods, strikes, public health emergencies, electrical outages, equipment or transmission failure, or other causes reasonably beyond its control. This Agreement and any joint instructions from the Parties may be executed in one or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument or instruction, as applicable. This Agreement may be executed and transmitted as a PDF attached to an email and each such execution shall be of the same legal effect, validity and enforceability as a manually executed original, wet-inked signature. If any provision of this Agreement is held to be illegal, invalid or unenforceable by reason of any applicable law of a jurisdiction, then such provision shall, as to such jurisdiction, be ineffective to the extent of such prohibition or unenforceability without invalidating the remaining provisions hereof, and any such prohibition or unenforceability in such jurisdiction shall not invalidate or render unenforceable such provisions in any other jurisdiction. The Parties each represent, warrant and covenant on behalf of itself that (i) each document, notice, instruction or request provided by such Party to Escrow Agent shall comply with applicable laws and regulations; (ii) such Party has full power and authority (in the case of the Representative, limited liability company power and authority) to enter into this Agreement and to perform all of the duties and obligations to be performed by it hereunder; and (iii) the person(s) executing this Agreement on such Party's behalf and certifying Authorized Representatives in the applicable Schedule 1 has been duly and properly authorized to do so, and each Authorized Representative of such Party has been duly and properly authorized to take actions specified for such person in the applicable Schedule 1. Except as expressly provided in Section 7 above, nothing in this Agreement, whether express or implied, shall be construed to give to any person or entity other than Escrow Agent and the Parties any legal or equitable right, remedy, interest or claim under or in respect of the Fund or this Agreement.", "": "" }, { "Text": "[Signature Page Follows.]", "": "" }, { "Text": "IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the date first set forth above.", "": "" }, { "Text": "COMPANY", "": "" }, { "Text": "MITOKININ, INC.", "": "" }, { "Text": "By: Daniel de Roulet Jr. Name: Daniel de Roulet Jr. Title: Chief Executive Officer Phone: +1(347)668-8061 Email: dderoulet@mitokinin.com", "": "" }, { "Text": "REPRESENTATIVE", "": "" }, { "Text": "ESCROW AGENT", "": "" }, { "Text": "JPMORGAN CHASE BANK, N.A.", "": "" }, { "Text": "By: Name: Title:", "": "" }, { "Text": "SHAREHOLDER REPRESENTATIVE SERVICES LLC", "": "" }, { "Text": "By: Name: Title: Phone: Email:", "": "" }, { "Text": "[Signature Page to Escrow Agreement]", "": "" }, { "Text": "IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the date first set forth above.", "": "" }, { "Text": "COMPANY ESCROW AGENT", "": "" }, { "Text": "MITOKININ, INC. JPMORGAN CHASE BANK, N.A.", "": "" }, { "Text": "By: ___________________________ By: ___________________________ Name: Daniel de Roulet Jr. Name: ___________________________ Title: Chief Executive Officer Title: ___________________________ Phone: ___________________________ Email: ___________________________", "": "" }, { "Text": "REPRESENTATIVE", "": "" }, { "Text": "SHAREHOLDER REPRESENTATIVE SERVICES LLC", "": "" }, { "Text": "By: ___________________________ Name: Sam Riffe Title: Managing Director Phone: ___________________________ Email: ___________________________", "": "" }, { "Text": "[Signature Page to Escrow Agreement]", "": "" }, { "Text": "IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the date first set forth above.", "": "" }, { "Text": "COMPANY ESCROW AGENT", "": "" }, { "Text": "MITOKININ, INC. JPMORGAN CHASE BANK, N.A.", "": "" }, { "Text": "By: ___________________________ By: ___________________________ Name: Daniel de Roulet Jr. Name: ___________________________ Title: Chief Executive Officer Title: ___________________________ Phone: ___________________________ Email: ___________________________", "": "" }, { "Text": "REPRESENTATIVE", "": "" }, { "Text": "SHAREHOLDER REPRESENTATIVE SERVICES LLC", "": "" }, { "Text": "By: ___________________________ Name: ___________________________ Title: ___________________________ Phone: ___________________________ Email: ___________________________", "": "" }, { "Text": "Robert W. Hardy Vice President", "": "" }, { "Text": "EXHIBIT A-1", "": "" }, { "Text": "FORM OF ESCROW RELEASE NOTICE – JOINT WRITTEN INSTRUCTIONS", "": "" }, { "Text": "JPMorgan Chase Bank, N.A. Escrow Services 10 South Dearborn Street; Mail Code IL1-0113 Chicago, IL 60603 Attention: Cindy Reis Fax No.: (312) 954-0430 Email Address: mw.escrow@jpmorgan.com", "": "" }, { "Text": "[Date]", "": "" }, { "Text": "Re: Mitokinin, Inc. and Shareholder Representative Services LLC – Escrow Agreement dated October 4, 2023 Escrow Account no. [ ]", "": "" }, { "Text": "Dear Sir/Madam:", "": "" }, { "Text": "We refer to an escrow agreement, dated October 4, 2023 (the \"Escrow Agreement\"), among Mitokinin, Inc. (the \"Company\"), Shareholder Representative Services LLC, as representative of the Indemnifying Stockholders (as defined in the Escrow Agreement), and JPMorgan Chase Bank, N.A., as Escrow Agent.", "": "" }, { "Text": "Capitalized terms in this letter that are not otherwise defined shall have the same meaning given to them in the Escrow Agreement.", "": "" }, { "Text": "Pursuant to Section 3 of the Escrow Agreement, the Parties instruct Escrow Agent to release [the entirety of the Fund] [the portion of the Fund specified below] to the specified party as instructed below.", "": "" }, { "Text": "[Amount (In writing): [INSERT ONLY IF LESS THAN THE ENTIRE FUND IS BEING DISBURSED]] Beneficiary: City: Country:", "": "" }, { "Text": "US Instructions: Bank Name: Bank Address: ABA Number: Credit A/C Name: Credit A/C #: Credit A/C Address: If Applicable:", "": "" }, { "Text": "FFC A/C Name: FFC A/C #: FFC A/C Address:", "": "" }, { "Text": "International Instructions: Bank Name: Bank Address SWIFT Code: US Pay Through ABA: Credit A/C Name: Credit A/C # (IBAN #): Credit A/C Address: If Applicable:", "": "" }, { "Text": "FFC A/C Name: FFC A/C # (IBAN #): FFC A/C Address:", "": "" }, { "Text": "EXHIBIT A-2", "": "" }, { "Text": "FORM OF INDEMNIFICATION CLAIM NOTICE", "": "" }, { "Text": "JPMorgan Chase Bank, N.A. Escrow Services 10 South Dearborn Street; Mail Code IL1-0113 Chicago, IL 60603 Attention: Cindy Reis Fax No.: (312) 954-0430 Email Address: mw.escrow@jpmorgan.com", "": "" }, { "Text": "Shareholder Representative Services LLC [address] [city, state, zip (postal code)] Attention: Email Address:", "": "" }, { "Text": "[Date]", "": "" }, { "Text": "Re: Mitokinin, Inc. and Shareholder Representative Services LLC – Escrow Agreement dated October 4, 2023 Escrow Account no. [ ]", "": "" }, { "Text": "Dear Sir/Madam:", "": "" }, { "Text": "This notice is being delivered pursuant to Section 3 of the Escrow Agreement, dated October 4, 2023 (the \"Escrow Agreement\"), among Mitokinin, Inc. (the \"Company\"), Shareholder Representative Services LLC, as representative of the Indemnifying Stockholders (as defined in the Escrow Agreement) (\"Representative\"), and JPMorgan Chase Bank, N.A., as Escrow Agent. Capitalized terms in this letter that are not otherwise defined shall have their meanings set forth in the Escrow Agreement.", "": "" }, { "Text": "The Company hereby gives notice pursuant to Section 3 of the Escrow Agreement, of a claim for indemnification made under [underlying agreement]. The amount of the claim is $______________.", "": "" }, { "Text": "The summary for the basis of such claim is as follows:", "": "" }, { "Text": "[Insert details]", "": "" }, { "Text": "The Company hereby certifies to Escrow Agent that this notice was delivered to Representative.", "": "" }, { "Text": "COMPANY", "": "" }, { "Text": "MITOKININ, INC.", "": "" }, { "Text": "By: ________________________ Name: Title:", "": "" }, { "Text": "EXHIBIT A-3", "": "" }, { "Text": "FORM OF INDEMNIFICATION CLAIM OBJECTION NOTICE", "": "" }, { "Text": "JPMorgan Chase Bank, N.A. Escrow Services 10 South Dearborn Street; Mail Code IL1-0113 Chicago, IL 60603 Attention: Cindy Reis Fax No.: (312) 954-0430 Email Address: mw.escrow@jpmorgan.com", "": "" }, { "Text": "Mitokinin, Inc. c/o AbbVie Inc. 1 North Waukegan Road North Chicago, IL 60064 Attention: Vice Chairman, External Affairs, Chief Legal Officer and Corporate", "": "" }, { "Text": "[Date]", "": "" }, { "Text": "Re: Mitokinin, Inc. and Shareholder Representative Services LLC – Escrow Agreement dated October 4, 2023 Escrow Account no. [ ]", "": "" }, { "Text": "Dear Sir/Madam:", "": "" }, { "Text": "This notice is being delivered pursuant to Section ___ of the Escrow Agreement, dated October 4, 2023 (the \"Escrow Agreement\"), among Mitokinin, Inc. (the \"Company\"), Shareholder Representative Services LLC, as representative of the Indemnifying Stockholders (as defined in the Escrow Agreement) (\"Representative\"), and JPMorgan Chase Bank, N.A., as Escrow Agent. Capitalized terms in this letter that are not otherwise defined shall have their meanings set forth in the Escrow Agreement.", "": "" }, { "Text": "Representative (on behalf of the Indemnifying Stockholders) hereby objects to the claim for indemnification filed by the Company, as described in the notice delivered by the Company to Escrow Agent dated ___________________, and requests that the amount of such claim not be disbursed to Representative.", "": "" }, { "Text": "Representative hereby certifies to Escrow Agent that this notice was delivered to the Company.", "": "" }, { "Text": "REPRESENTATIVE", "": "" }, { "Text": "SHAREHOLDER REPRESENTATIVE SERVICES LLC", "": "" }, { "Text": "By: ________________________ Name: Title:", "": "" }, { "Text": "Schedule 1-A", "": "" }, { "Text": "MITOKININ, INC.", "": "" }, { "Text": "DESIGNATION OF AUTHORIZED REPRESENTATIVES", "": "" }, { "Text": "The undersigned, Daniel de Roulet Jr., being the duly elected, qualified and acting Chief Executive Officer of Mitokinin, Inc. (the \"Company\"), does hereby certify:", "": "" }, { "Text": "1. That each of the following representatives is at the date hereof an Authorized Representative, as such term is defined in the Escrow Agreement, by and among the Company, Shareholder Representative Services LLC, as representative of the Indemnifying Stockholders (as defined in the Escrow Agreement), and Escrow Agent, to which this Schedule is attached, that the signature appearing opposite each Authorized Representative's name is the true and genuine signature of such Authorized Representative, and that each Authorized Representative's contact information is current and up-to-date at the date hereof. Each of the Authorized Representatives is authorized to issue instructions, confirm funds transfer instructions by callback or email confirmation and effect changes in Authorized Representatives, all in accordance with the terms of the Escrow Agreement. Callbacks or emails confirming an instruction shall be made to an Authorized Representative other than the Authorized Representative who issued the instruction unless (a) only a single Authorized Representative is designated below, (b) the information set forth below changes and is not updated by the Company such that only the Authorized Representative who issued the instruction is available to receive a callback or email confirmation, or (c) the Company is an individual. The Company acknowledges that pursuant to this Schedule, Escrow Agent is offering an option for callback or email confirmation to a different Authorized Representative, and if the Company nevertheless names only a single Authorized Representative or fails to update Authorized Representative information, the Company agrees to be bound by any instruction, whether or not authorized, confirmed by callback or email confirmation to the issuer of the instruction.", "": "" }, { "Text": "NAME SIGNATURE DIRECT TELEPHONE, CELL NUMBER and EMAIL ADDRESS", "": "" }, { "Text": "Timothy Kolenda _________________________ (ph) 847-935-1585 (cell) 847-393-6432 (email) timothy.kolenda@abbvie.com", "": "" }, { "Text": "Wayne Klintworth _________________________ (ph) 847-938-9286 (cell) 847-323-0036 (email) wayne.klintworth@abbvie.com", "": "" }, { "Text": "Stefan Geldmeyer _________________________ (ph) 847-937-3088 (cell) 408-718-8418 (email) stefan.geldmeyer@abbvie.com", "": "" }, { "Text": "Lindsey Bristow _________________________ (ph) 847-938-7626 (cell) 224-280-3305 (email) lindsey.bristow@abbvie.com", "": "" }, { "Text": "2. Email confirmation not accompanied by other means of authentication (such as DocuSign initiated by Escrow Agent) approved by Escrow Agent is permitted only to a business email address (and not a personal email address) for purposes of this Schedule.", "": "" }, { "Text": "3. This Schedule may be signed in counterparts and the undersigned certifies that any signature set forth on an attachment to this Schedule is the true and genuine signature of an Authorized Representative and that each such Authorized Representative's contact information is current and up-to-date at the date hereof.", "": "" }, { "Text": "4. That pursuant to the Company's governing documents, as amended, the undersigned has the power and authority to execute this Designation on behalf of the Company.", "": "" }, { "Text": "Schedule 1-B", "": "" }, { "Text": "SHAREHOLDER REPRESENTATIVE SERVICES LLC", "": "" }, { "Text": "DESIGNATION OF AUTHORIZED REPRESENTATIVES", "": "" }, { "Text": "The undersigned, Sam Riffe, being the duly elected, qualified and acting Managing Director of Shareholder Representative Services LLC (\"Representative\"), does hereby certify:", "": "" }, { "Text": "1. That each of the following representatives is at the date hereof an Authorized Representative, as such term is defined in the Escrow Agreement, by and among Mitokinin, Inc., Representative, as the representative of the Indemnifying Stockholders (as defined in the Escrow Agreement), and Escrow Agent to which this Schedule is attached, that the signature appearing opposite each Authorized Representative's name is the true and genuine signature of such Authorized Representative, and that each Authorized Representative's contact information is current and up-to-date at the date hereof. Each of the Authorized Representatives is authorized to issue instructions, confirm funds transfer instructions by callback or email confirmation and effect changes in Authorized Representatives, all in accordance with the terms of the Escrow Agreement. Callbacks or emails confirming an instruction shall be made to an Authorized Representative other than the Authorized Representative who issued the instruction unless (a) only a single Authorized Representative is designated below, (b) the information set forth below changes and is not updated by Representative such that only the Authorized Representative who issued the instruction is available to receive a callback or email confirmation, or (c) Representative is an individual. Representative acknowledges that pursuant to this Schedule, Escrow Agent is offering an option for callback or email confirmation to a different Authorized Representative, and if Representative nevertheless names only a single Authorized Representative or fails to update Authorized Representative information, Representative agrees to be bound by any instruction, whether or not authorized, confirmed by callback or email confirmation to the issuer of the instruction.", "": "" }, { "Text": "NAME SIGNATURE DIRECT TELEPHONE, CELL NUMBER and EMAIL ADDRESS", "": "" }, { "Text": "Casey McTigue ____________________________ (ph) (415) 363-6081 (email) cmctigue@srsacquiom.com", "": "" }, { "Text": "Michelle Kirkpatrick ____________________________ (ph) (720) 799-8614 (email) mkirkpatrick@srsacquiom.com", "": "" }, { "Text": "Lon LeClair ____________________________ (ph) (303) 222-2078 (email) lleclair@srsacquiom.com", "": "" }, { "Text": "Paul Koenig ____________________________ (ph) (303) 957-2850 (email) pkoenig@srsacquiom.com", "": "" }, { "Text": "The below individuals are authorized to perform a confirmation via telephone callback (in the order listed below):", "": "" }, { "Text": "NAME TELEPHONE", "": "" }, { "Text": "Greg Johnson (ph) (720) 681-6638", "": "" }, { "Text": "Lynn Curtin (ph) (720) 966-1820", "": "" }, { "Text": "Casey McTigue (ph) (415) 363-6081", "": "" }, { "Text": "Michelle Kirkpatrick (ph) (720) 799-8614", "": "" }, { "Text": "Lon LeClair (ph) (303) 222-2078", "": "" }, { "Text": "Paul Koenig (ph) (303) 957-2850", "": "" }, { "Text": "2. Email confirmation not accompanied by other means of authentication (such as DocuSign initiated by Escrow Agent) approved by Escrow Agent is permitted only to a business email address (and not a personal email address) for purposes of this Schedule.", "": "" }, { "Text": "3. This Schedule may be signed in counterparts and the undersigned certifies that any signature set forth on an attachment to this Schedule is the true and genuine signature of an Authorized Representative and that each such Authorized Representative's contact information is current and up-to-date at the date hereof.", "": "" }, { "Text": "4. That pursuant to Representative's governing documents, as amended, the undersigned has the power and authority to execute this Designation on behalf of Representative.", "": "" }, { "Text": "Signature: _____________________________ Name: Sam Riffe Title: Managing Director", "": "" }, { "Text": "FOR YOUR SECURITY, PLEASE CROSS OUT ALL UNUSED SIGNATURE LINES ON THIS SCHEDULE 1-B", "": "" }, { "Text": "All instructions, including but not limited to funds transfer instructions, whether set forth in a PDF attached to an email or through an online platform offered by Escrow Agent's escrow services business, must include the signature (or electronic signature subject to the conditions set forth in the Escrow Agreement) of the Authorized Representative authorizing said funds transfer on behalf of such Party.", "": "" }, { "Text": "SCHEDULE 2", "": "" }, { "Text": "Schedule of Fees for Escrow Agent Services", "": "" }, { "Text": "Account Acceptance Fee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Waived Encompassing review, negotiation and execution of governing documentation, opening of the account, and completion of all due diligence documentation. Payable upon closing.", "": "" }, { "Text": "Annual Administration Fee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $3,000 The Administration Fee covers our usual and customary ministerial duties, including record keeping, distributions, document compliance and such other duties and responsibilities expressly set forth in the governing documents for each transaction. Payable upon closing and annually in advance thereafter, without pro-ration for partial years.", "": "" }, { "Text": "Extraordinary Services and Out-of-Pocket Expenses: Escrow Agent or any of its affiliates may receive compensation with respect to any investment directed hereunder including without limitation charging any applicable agency fee or trade execution fee in connection with each transaction. Any additional services beyond our standard services as specified above, and all reasonable out-of-pocket expenses including attorney's or accountant's fees and expenses will be considered extraordinary services for which related costs, transaction charges, and additional fees will be billed at Escrow Agent's then standard rate. Escrow Agent may impose, charge, debit, pass-through and modify fees and/or charges for any account established and services provided by Escrow Agent, including but not limited to, transaction, maintenance, balance-deficiency, and service fees, agency or trade execution fees, and other charges, including those levied by any governmental authority.", "": "" }, { "Text": "Fee Disclosure & Assumptions: Please note that the fees quoted are based on a review of the transaction documents provided and an internal due diligence review, and assumes the escrow deposit will be continuously invested in a MMDA at JPMorgan Chase Bank, N.A. Escrow Agent reserves the right to revise, modify, change and supplement the fees quoted herein if the assumptions underlying the activity in the account, level of balances, market volatility or other factors change from those used to set the fees described herein.", "": "" }, { "Text": "Payment of the invoice is due upon receipt.", "": "" }, { "Text": "Disclosures and Agreements:", "": "" }, { "Text": "Taxes. The Company shall duly complete such tax documentation or other procedural formalities necessary for Escrow Agent to complete required tax reporting and for the Company or the Indemnifying Stockholders to receive interest or other income without withholding or deduction of tax in any jurisdiction. Should any information supplied in such tax documentation change, the Company shall promptly notify Escrow Agent. Escrow Agent shall withhold any taxes required to be withheld by applicable law in the absence of proper tax documentation, including without limitation, the Foreign Account Tax Compliance Act (\"FATCA\"), and shall remit such taxes to the appropriate authorities.", "": "" }, { "Text": "Know Your Customer. To assist in the prevention of the funding of terrorism and money laundering activities, applicable law may require financial institutions to obtain, verify, and record information that identifies each person who opens an account. What this means for the Parties: when the Parties open an account, Escrow Agent may ask for each Party's name, address, date of birth (for natural persons), and/or other information and documents that will allow Escrow Agent to identify such Party. Escrow Agent may also request and obtain certain information from third party vendors regarding any Party. To fulfill Escrow Agent's \"know your customer\" responsibilities and in connection with its performance of this Agreement, Escrow Agent may request information and/or documentation from each Party from time to time, including, without limitation, regarding such Party's organization, business and, to the extent applicable, beneficial owner(s) of such Party, including relevant natural or legal persons, and such Party shall procure and furnish the same to Escrow Agent in a timely manner. Any information and/or documentation furnished by any Party is the sole responsibility of such Party and Escrow Agent is entitled to rely on the information and/or documentation without making any verification whatsoever (except for the authentication under the security procedures, as applicable). Each Party represents and warrants that all such information and/or documentation is true, correct and not misleading and shall advise Escrow Agent promptly of any changes and, except as prohibited by applicable law, such Party agrees to provide complete responses to Escrow Agent's requests within the timeframes specified. If any Party fails to provide or consent to the provision of any information required by this paragraph, Escrow Agent may suspend or discontinue providing any service hereunder and resign pursuant to this Agreement.", "": "" }, { "Text": "OFAC Disclosure. Escrow Agent is required to act in accordance with the laws and regulations of various jurisdictions relating to the prevention of money laundering and the implementation of sanctions, including but not limited to regulations issued by the U.S. Office of Foreign Assets Control. Escrow Agent is not obligated to execute payment orders or effect any other transaction where the beneficiary or other payee is a person or entity with whom Escrow Agent is prohibited from doing business by any law or regulation applicable to Escrow Agent, or in any case where compliance would, in Escrow Agent's opinion, conflict with applicable law or banking practice or its own policies and procedures. Where Escrow Agent does not execute a payment order or effect a transaction for such reasons, Escrow Agent may take any action required by any law or regulation applicable to Escrow Agent including, without limitation, freezing or blocking funds. Transaction screening may result in delays in the posting of transactions.", "": "" }, { "Text": "Abandoned Property. Escrow Agent is required to act in accordance with the laws and regulations of various states relating to abandoned property, escheatment or similar law and, accordingly, shall be entitled to remit dormant funds to any state as abandoned property in Schedule of Fees and Disclosures for Escrow Agent Services", "": "" }, { "Text": "accordance with such laws and regulations. Without limitation of the foregoing, notwithstanding any instruction to the contrary, Escrow Agent shall not be liable to any Party for any amount disbursed from an account maintained under this Agreement to a governmental entity or public official in compliance with any applicable abandoned property, escheatment or similar law.", "": "" }, { "Text": "Information. Escrow Agent agrees to take customary and reasonable measures to maintain the confidentiality of each Party's confidential information. Confidential information shall not include information that (a) is publicly available other than as a result of Escrow Agent's breach of this Agreement, (b) was obtained from a third party not known by Escrow Agent to be under an obligation of confidentiality with respect to such information or (c) was independently developed by Escrow Agent. The Parties authorize Escrow Agent to disclose information with respect to this Agreement and the account(s) established hereunder, the Parties, or any transaction hereunder if such disclosure is: (i) necessary in Escrow Agent's opinion, for the purpose of allowing Escrow Agent to perform its duties and to exercise its powers and rights hereunder or for operational or risk management purposes or compliance with legal, tax and regulatory requirements, including, without limitation, FATCA; (ii) to a proposed assignee of the rights of Escrow Agent; (iii) to a branch, affiliate, subsidiary, employee or agent of Escrow Agent or to their auditors, regulators or legal advisers or to any competent court; (iv) to the auditors of any of the Parties; or (v) required by applicable law, regardless of whether the disclosure is made in the country in which each Party resides, in which the escrow account is maintained, or in which the transaction is conducted. The Parties agree that such disclosures by Escrow Agent and its affiliates may be transmitted across national boundaries and through networks, including those owned by third parties.", "": "" }, { "Text": "Acknowledgment of Compensation and Multiple Roles. Escrow Agent is authorized to act under this Agreement notwithstanding that Escrow Agent or any of its subsidiaries or affiliates (such subsidiaries and affiliates hereafter individually called an \"Affiliate\" and collectively called \"Affiliates\") may (A) receive fees or derive earnings (float) as a result of providing an investment product or account on the books of Escrow Agent pursuant to this Agreement or for providing services or referrals with respect to investment products, or (B) (i) act in the same transaction in multiple capacities, (ii) engage in other transactions or relationships with the same entities to which Escrow Agent may be providing escrow or other services under this Agreement, (iii) refer clients to an Affiliate for services or (iv) enter into agreements under which referrals of escrow or related transactions are provided to Escrow Agent. JPMorgan Chase Bank, N.A. may earn compensation from any of these activities in addition to the fees charged for services under this Agreement.", "": "" }, { "Text": "FDIC Disclosure. In the event Escrow Agent becomes insolvent or enters into receivership, Escrow Agent may provide to the Federal Deposit Insurance Corporation (\"FDIC\") account balance information for any account governed by this Agreement, as reflected on Escrow Agent's end-of-day ledger balance, and the customer name and tax identification number associated with such accounts for the purposes of determining the appropriate deposit insurance coverage. Funds held in such accounts will be insured by the FDIC under its applicable rules and limits.", "": "" }, { "Text": "THE FOLLOWING DISCLOSURES ARE REQUIRED TO BE PROVIDED UNDER APPLICABLE U.S. REGULATIONS, INCLUDING, BUT NOT LIMITED TO, FEDERAL RESERVE REGULATION D. WHERE SPECIFIC INVESTMENTS ARE NOTED BELOW, THE DISCLOSURES APPLY ONLY TO THOSE INVESTMENTS AND NOT TO ANY OTHER INVESTMENT.", "": "" }, { "Text": "Demand Deposit Account Disclosure. Escrow Agent is authorized, for regulatory reporting and internal accounting purposes, to divide an escrow demand deposit account maintained in the U.S. in which the Fund is held into a demand deposit internal account and a savings internal account, and to transfer funds on a daily basis between these internal accounts on Escrow Agent's general ledger in accordance with U.S. law at no cost to the Parties. Escrow Agent will record the internal accounts and any transfers between them on Escrow Agent's books and records only. The internal accounts and any transfers between them will not affect the Fund, any investment or disposition of the Fund, use of the escrow demand deposit account or any other activities under this Agreement, except as described herein. Escrow Agent will establish a target balance for the demand deposit internal account, which may change at any time. To the extent funds in the demand deposit internal account exceed the target balance, the excess will be transferred to the savings internal account, unless the maximum number of transfers from the savings internal account for that calendar month or statement cycle has already occurred. If withdrawals from the demand deposit internal account exceeds the available balance in the demand deposit internal account, funds from the savings internal account will be transferred to the demand deposit internal account up to the entire balance of available funds in the savings internal account to cover the shortfall and to replenish any target balance that Escrow Agent has established for the demand deposit internal account. If a sixth transfer is needed during a calendar month or statement cycle, it will be for the entire balance in the savings internal account, and such funds will remain in the demand deposit internal account for the remainder of the calendar month or statement cycle.", "": "" }, { "Text": "MMDA Disclosure and Agreement. Escrow Agent is required by U.S. law to reserve the right to require at least seven (7) days' notice prior to a withdrawal from a money market deposit account.", "": "" }, { "Text": "Account Use. The Parties acknowledge and agree that the Fund may not be deposited or withdrawn by the Parties unless pursuant to the terms of this Agreement and consistent with the underlying purpose of this Agreement as communicated to Escrow Agent by the Parties, and the Fund will not be used for the general operating needs of the Parties while the Fund is held in any accounts governed by this Agreement.", "": "" }, { "Text": "Unlawful Internet Gambling. The use of any account to conduct transactions (including, without limitation, the acceptance or receipt of funds through an electronic funds transfer, or by check, draft or similar instrument, or the proceeds of any of the foregoing) that are related, directly or indirectly, to unlawful Internet gambling is strictly prohibited.", "": "" }, { "Text": "Recordings. Each Party and Escrow Agent consent to the other party or parties making and retaining recordings of telephone conversations between any Party or Parties on one hand and Escrow Agent on the other hand in connection with Escrow Agent's security procedures.", "": "" }, { "Text": "Use of Electronic Records and Signatures. As used in this Agreement, the terms \"writing\" and \"written\" include electronic records, and the terms \"execute\", \"signed\" and \"signature\" include the use of electronic signatures. Notwithstanding any other provision of this Agreement or the attached Exhibits and Schedules, any electronic signature that is presented as the signature of the purported signer, regardless of the appearance or form of such electronic signature, may be deemed genuine by Escrow Agent in Escrow Agent's sole discretion, and such electronic signature shall be of the same legal effect, validity and enforceability as a manually executed, original, wet-inked signature. Any electronically signed agreement shall be an \"electronic record\" established in the ordinary course of business and any copy shall constitute an original for all purposes. The terms \"electronic signature\" and \"electronic record\" shall have the meanings ascribed to them in 15 USC § 7006. This Agreement and any instruction or other document furnished hereunder may be transmitted as a PDF file attached to an email.", "": "" }, { "Text": "SCHEDULE 3", "": "" }, { "Text": "STANDING INSTRUCTIONS", "": "" }, { "Text": "Company: Paying Agent:", "": "" }, { "Text": "Bank Name: Bank Name: JPMorgan Chase Bank, N.A.", "": "" }, { "Text": "Bank Address: Bank Address: 10 S. Dearborn St. Chicago, IL 60603", "": "" }, { "Text": "ABA number: ABA number: 021000021", "": "" }, { "Text": "Credit A/C Name: Credit A/C Name: TBD", "": "" }, { "Text": "Credit A/C # Credit A/C # TBD", "": "" }, { "Text": "If Applicable: If Applicable:", "": "" }, { "Text": "FFC A/C Name: FFC A/C Name:", "": "" }, { "Text": "FFC A/C #: FFC A/C #:", "": "" }, { "Text": "FFC A/C Address: FFC A/C Address:", "": "" }, { "Text": "SCHEDULE 4", "": "" }, { "Text": "ESCROW DIRECT (ONLINE PLATFORM) – ADDITIONAL USERS", "": "" }, { "Text": "Please list the names and email addresses of any additional contacts other than Authorized Representatives and contacts with email addresses listed in the Notice Section who shall have access for this transaction in Escrow Direct. Note that Authorized Representatives will be entitled to full access to Escrow Direct and contacts with email addresses in the notice section will automatically be added as additional users.", "": "" }, { "Text": "Company:", "": "" }, { "Text": "Name: Email Address:", "": "" }, { "Text": "Name: Email Address:", "": "" }, { "Text": "Confidential Execution Copy", "": "" }, { "Text": "LICENSE AND COLLABORATION AGREEMENT", "": "" }, { "Text": "THIS LICENSE AND COLLABORATION AGREEMENT (this \"Agreement\"), entered into as of May 14, 2021 (the \"Effective Date\"), is entered into by and between LianBio Respiratory Limited, a company limited by shares organized and existing under the laws of Hong Kong Special Administrative Region of the People's Republic of China (\"Lian\"), and Landos BioPharma, Inc., a Delaware corporation (\"Landos\").", "": "" }, { "Text": "INTRODUCTION", "": "" }, { "Text": "WHEREAS, Lian wishes to obtain from Landos and Landos wishes to grant to Lian certain rights and licenses under intellectual property owned or controlled by Landos to Develop, Manufacture, and Commercialize Licensed Products in the Field in the Territory (each as defined below), subject to the terms and conditions set forth herein.", "": "" }, { "Text": "NOW, THEREFORE, the Parties hereby agree as follows:", "": "" }, { "Text": "ARTICLE 1 DEFINITIONS", "": "" }, { "Text": "Unless the context clearly indicates otherwise, the following terms used in this Agreement will have the meanings set forth in this Article 1 (Definitions):", "": "" }, { "Text": "1.1 \"Accounting Standards\" means, with respect to a Person, generally accepted accounting principles (\"GAAP\") as practiced in the United States or applicable international standards followed by such Person.", "": "" }, { "Text": "1.2 \"Acquired Party\" has the meaning set forth in Section 2.9(c) (Business Combinations).", "": "" }, { "Text": "1.3 \"Acquirer\" means, collectively, the Third Party referenced in the definition of Change of Control and such Third Party's Affiliates, other than the applicable Party in the definition of Change of Control and such Party's Affiliates, determined as of immediately prior to the closing of such Change of Control.", "": "" }, { "Text": "1.4 \"Action\" means any claim, action, cause of action, or suit (whether in contract or tort or otherwise), litigation (whether at law or in equity, whether civil or criminal), assessment, arbitration, investigation, hearing, charge, complaint, demand, notice or proceeding of, to, from, by or before any Governmental Authority.", "": "" }, { "Text": "1.5 \"Active Ingredient\" means those active materials that provide pharmacological activity in a pharmaceutical or biologic product (excluding formulation components such as coatings, stabilizers, excipients or solvents, adjuvants, or controlled release technologies).", "": "" }, { "Text": "1.6 \"Additional Product\" means any pharmaceutical compound or product, other than a Compound or Licensed Product, that has the same mechanism of action as any Compound and is being Developed by Landos for use outside the Territory.", "": "" }, { "Text": "1.7 \"Additional Product License\" has the meaning set forth in Section 2.10 (Right of Negotiation).", "": "" }, { "Text": "1.8 \"Adverse Event\" or \"AE\" means any untoward medical occurrence associated with the use of a product in human subjects, whether or not considered related to such product. An AE does not necessarily have a causal relationship with a product, that is, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of such product.", "": "" }, { "Text": "1.9 \"Affiliate\" means, with respect to any Person, any entity controlling, controlled by or under common control with such first Person, at the time that the determination of affiliation is made and for as long as such control exists. For purposes of this definition, \"control\" means (i) direct or indirect ownership of more than 50% of the stock or shares having the right to vote for the election of directors of such Person (or if the jurisdiction where such Person is domiciled prohibits foreign ownership of such entity, the maximum foreign ownership interest permitted under such Laws; provided, however, that such ownership interest provides actual control over such Person), (ii) status as a general partner in any partnership, or (iii) the possession, directly or indirectly, of the power to direct, or cause the direction of, the management or policies of such Person, whether through the ownership of voting securities, by contract or otherwise. Affiliates of a Party exclude Persons who are financial investors of such Party or under common control of such financial investors other than such Party and its subsidiary entities.", "": "" }, { "Text": "1.10 \"Agreement\" has the meaning set forth in the Preamble.", "": "" }, { "Text": "1.11 \"Alliance Manager\" has the meaning set forth in Section 5.7(a) (Appointment).", "": "" }, { "Text": "1.12 \"Anti-Corruption Laws\" means laws, regulations, or orders prohibiting the provision of a financial or other advantage for a corrupt purpose or otherwise in connection with the improper performance of a relevant function, including, to the extent applicable, the Corruption of Foreign Public Officials Act (CFPOA), the US Foreign Corrupt Practices Act (FCPA), the UK Bribery Act 2010, and similar laws governing corruption and bribery, whether public, commercial or both.", "": "" }, { "Text": "1.13 \"Average Cost Per Patient\" means the direct per patient cost in the Territory for a particular Global Phase III Trial, as reasonably estimated by Lian or its then-current CRO at the time of commencement of such Global Phase III Trial.", "": "" }, { "Text": "1.14 \"Breaching Party\" has the meaning set forth in Section 12.3(a) (Termination of Material Breach).", "": "" }, { "Text": "1.15 \"Business Day\" means any day, other than a Saturday or a Sunday, on which the banks in New York, Beijing, Hong Kong, and Cayman Islands are open for business.", "": "" }, { "Text": "1.16 \"Calendar Quarter\" means each of the three month periods ending on March 31, June 30, September 30, and December 31 of any Calendar Year.", "": "" }, { "Text": "1.17 \"Calendar Year\" means, for the first Calendar Year, the period beginning on the Effective Date and ending on December 31, 2020, and for each Calendar Year thereafter each 12-month period commencing on January 1, and ending on December 31, except that the last Calendar Year will commence on January 1 of the year in which this Agreement expires or terminates and end on the effective date of such expiration or termination.", "": "" }, { "Text": "1.18 \"CDE\" means the Center for Drug Evaluation of the NMPA.", "": "" }, { "Text": "1.19 \"Change of Control\" means, with respect to a Party, (a) a merger or consolidation of such Party with a Third Party that results in the voting securities of such Party outstanding immediately prior thereto, or any securities into which such voting securities have been converted or exchanged, ceasing to represent more than 50% of the combined voting power of the surviving entity or the parent of the surviving entity immediately after such merger or consolidation, (b) a transaction or series of related transactions in which a Third Party, together with its Affiliates, becomes the direct or indirect beneficial owner of more than 50% of the combined voting power of the outstanding securities of such Party, or (c) the sale or other transfer to a Third Party of all or substantially all of such Party's and its controlled Affiliates' assets. Notwithstanding the foregoing, any transaction or series of transactions effected for the primary purpose of financing the operations of the applicable Party (including the issuance or sale of securities for financing purposes) or changing the form or jurisdiction of organization of such Party will not be deemed a \"Change of Control\" for purposes of this Agreement.", "": "" }, { "Text": "1.20 \"Clinical Trial\" means a trial in which human subjects or patients are dosed with a drug, whether approved or investigational.", "": "" }, { "Text": "1.21 \"Clinical Supply Agreement\" has the meaning set forth in Section 4.1 (Supply Agreement).", "": "" }, { "Text": "1.22 \"CMC\" means the Chemistry, Manufacturing, and Controls portion of any Regulatory Filing.", "": "" }, { "Text": "1.23 \"CMC Data\" means any data included in the CMC portion of a Regulatory Filing or in any supporting development reports thereto, in each case, with respect to any Licensed Product in any country in the world.", "": "" }, { "Text": "1.24 \"Combination Product\" means a Licensed Product that (a) contains or comprises both (i) the Compound and (ii) at least one additional Active Ingredient other than a Compound, whether packaged together or in a single finished dosage form, (b) sold for a single invoice price together with any (i) delivery device or component therefor, (ii) companion diagnostic related to any Licensed Product, or (iii) product, process, service, or therapy other than the Licensed Product (such additional Active Ingredient and each of (i) – (iii), an \"Other Component\") or (c) that is defined as a \"combination product\" by the FDA pursuant to 21 C.F.R. §3.2(e) or its foreign equivalent.", "": "" }, { "Text": "1.25 \"Commercial Supply Agreement\" has the meaning set forth in Section 4.1 (Supply Agreement).", "": "" }, { "Text": "1.26 \"Commercialization\" means any and all activities related to the pre-marketing, launching, marketing, promotion (including advertising and detailing), labeling, bidding and listing, pricing and reimbursement, distribution, storage, handling, offering for sale, selling, having sold, importing and exporting for sale, having imported and exported for sale, distribution, having distributed, customer service and support, and post-marketing safety surveillance and reporting of a product (including the Licensed Product), but not including Development activities or Manufacturing. \"Commercializing\" or \"Commercialize\" will be construed accordingly.", "": "" }, { "Text": "1.27 \"Commercially Reasonable Efforts\" means, in respect of a Party, the level of efforts and resources (measured as of the time that such efforts and resources are required to be used under this Agreement) that are commonly used by a company in the industry of a similar size and profile as such Party to Develop, Manufacture, or Commercialize, as the case may be, a product owned by such company or to which it has rights, which product is at a similar stage in its development or product life and is of a similar market and profitability potential to the Licensed Product and taking into account all relevant factors, including the intellectual property protection of the product, product labeling or anticipated labeling, market potential, profitability and financial return, medical and clinical considerations, regulatory environments and competitive market conditions, market exclusivity, and other technical legal, scientific, medical, or commercial factors that such a company would reasonably deem to be relevant.", "": "" }, { "Text": "1.28 \"Competitive Product\" means any pharmaceutical compound or product, other than a Compound or Licensed Product, that has the same mechanism of action as any Compound.", "": "" }, { "Text": "1.29 \"Compound\" means (a) Landos' proprietary compounds known as BT-11 and NX-13, the chemical structure of which is set forth on Schedule 1.29 (Licensed Compounds), and (b) any salt, ester, hydrate, solvate, enantiomer, free acid form, free base form, crystalline form, co-crystalline form, amorphous form, pro-drug (including ester pro-drug) form, racemate, polymorph, chelate, stereoisomer, tautomer, or optically active form of any of the foregoing.", "": "" }, { "Text": "1.30 \"Confidential Information\" means (a) all trade secrets or confidential or proprietary information (including any tangible materials embodying any of the foregoing) of the disclosing Party or its Affiliates provided or disclosed to the other Party or any of its Affiliates in connection with this Agreement or disclosed in connection with the Term Sheet, and (b) the terms and conditions of this Agreement; provided, however, that Confidential Information will not include information that: (i) is published by a Third Party or otherwise is or hereafter becomes part of the public domain by public use, publication, general knowledge, or the like through no breach of this Agreement on the part of the receiving Party; (ii) is in the receiving Party's possession prior to disclosure by the disclosing Party hereunder, and not through a prior disclosure by the disclosing Party, without any obligation of confidentiality with respect to such information; (iii) is subsequently received by the receiving Party from a Third Party who is not known by the receiving Party to be under an obligation of confidentiality to the disclosing Party; or (iv) is independently developed by or for the receiving Party without reference to, or use or disclosure of, the disclosing Party's Confidential Information.", "": "" }, { "Text": "1.31 \"Contract Manufacturing Organization\" or \"CMO\" means any Third Party contract manufacturing organization.", "": "" }, { "Text": "1.32 \"Control\" or \"Controlled\" means the possession by a Party (whether by ownership, license, or otherwise other than pursuant to this Agreement) of, (a) with respect to any tangible Know-How, the legal authority or right to physical possession of such tangible Know-How, with the right to provide such tangible Know-How to the other Party on the terms set forth herein, or (b) with respect to Patent Rights, Regulatory Approvals, Regulatory Filings, intangible Know-How, or other Intellectual Property, the legal authority or right to grant a license, sublicense, access, or right to use (as applicable) to the other Party under such Patent Rights, Regulatory Approvals, Regulatory Filings, intangible Know-How, or other Intellectual Property on the terms set forth herein, in each case ((a) and (b)), without breaching or otherwise violating the terms of any arrangement or agreement with a Third Party in existence as of the time such Party or its Affiliates would first be required hereunder to grant the other Party such access, right to use, licenses, or sublicense. Notwithstanding anything in this Agreement to the contrary, a Party will be deemed not to Control any Patent Rights, Know-How, Regulatory Filing, Regulatory Approval, or other property right that are owned or in-licensed by an Acquirer except (i) with respect to any such Patent Rights, Know-How, Regulatory Filing, Regulatory Approval, or other property right arising from active participation by employees or consultants of the Acquirer in the Development, Manufacture, or Commercialization of Licensed Products in the Field after such Change of Control, or (ii) to the extent that any such Patent Rights, Know-How, Regulatory Filing, Regulatory Approval, or other property right are included in or used in furtherance of the Development, Manufacture, or Commercialization of Licensed Products in the Field by the Acquirer after such Change of Control.", "": "" }, { "Text": "1.33 \"Cover,\" \"Covering,\" or \"Covered\" means, when referring to the Licensed Product: (a) with respect to an issued Patent Right, that, in the absence of a license granted to a Person under an issued claim included in such Patent Right, the manufacture, use, sale, offer for sale or import by such Person of a specified activity with respect to such Licensed Product would infringe such claim, or (b) with respect to an application for Patent Rights, that, in the absence of a license granted to a Person under a claim included in such application, the manufacture, use, sale, offer for sale or import by such Person of such Licensed Product would infringe such claim if such patent application were to issue as a patent.", "": "" }, { "Text": "1.34 \"CRO\" means a Third Party contract research organization.", "": "" }, { "Text": "1.35 \"Development\" means all internal and external research, development, and regulatory activities related to pharmaceutical or biologic products, including (a) research, non-clinical testing, toxicology, testing and studies, non-clinical and preclinical activities, and Clinical Trials, and (b) preparation, submission, review, and development of data or information for the purpose of submission to a Regulatory Authority to obtain authorization to conduct Clinical Trials and to obtain, support, or maintain Regulatory Approval of a pharmaceutical or biologic product and interacting with Regulatory Authorities following receipt of Regulatory Approval in the applicable country or region for such pharmaceutical or biologic product regarding the foregoing, but excluding activities directed to Manufacturing or Commercialization. Development will include development and regulatory activities for additional forms, formulations, or indications for a pharmaceutical or biologic product after receipt of Regulatory Approval of such product (including label expansion), including Clinical Trials initiated following receipt of Regulatory Approval or any Clinical Trial to be conducted after receipt of Regulatory Approval that was mandated by the applicable Regulatory Authority as a condition of such Regulatory Approval with respect to an approved formulation or indication (such as post-marketing studies, observational studies, implementation and management of registries and analysis thereof, in each case, if required by any Regulatory Authority in any region in the Territory to support or maintain Regulatory Approval for a pharmaceutical or biologic product in such region). \"Develop,\" \"Developing,\" and \"Developed\" will be construed accordingly.", "": "" }, { "Text": "1.36 \"Development Milestone Event\" has the meaning set forth in Section 6.1(b) (Development Milestone Payment).", "": "" }, { "Text": "1.37 \"Development Milestone Payment\" has the meaning set forth in Section 6.1(b) (Development Milestone Payment).", "": "" }, { "Text": "1.38 \"Development Plan\" means the Territory-Specific Development Plan and the Global Development Plan, collectively.", "": "" }, { "Text": "1.39 \"Dollars\" or \"US$\" means United States dollars.", "": "" }, { "Text": "1.40 \"Effective Date\" has the meaning set forth in the Preamble.", "": "" }, { "Text": "1.41 \"FDA\" means the United States Food and Drug Administration or any successor agency thereto.", "": "" }, { "Text": "1.42 \"Field\" means all uses or indications.", "": "" }, { "Text": "1.43 \"First Commercial Sale\" means with respect to the Licensed Product in any Region in the Territory, the first sale for monetary value for use or consumption by the end user of such Licensed Product in such Region after the Marketing Authorization for such Licensed Product has been obtained in such Region and where the sale results in a recordable Net Sale. First Commercial Sale excludes transfers of Licensed Product to Third Parties as bona fide samples, for the performance of Clinical Trials or other Development purposes, or for any expanded access program, or any compassionate sales or use program in accordance with applicable Law.", "": "" }, { "Text": "1.44 \"Force Majeure\" has the meaning set forth in Section 14.9 (Force Majeure).", "": "" }, { "Text": "1.45 \"Fully Burdened Manufacturing Cost\" means, with respect to any Licensed Product (or the Compound contained therein) supplied by or on behalf of Landos to Lian: (a) if such Licensed Product (or the Compound contained therein) (or any precursor or intermediate thereof) is Manufactured by a CMO, the actual CMO costs of such Manufacturing incurred by or on behalf of Landos, including the costs of raw materials, intermediates and components, reference materials or standards required for release testing, materials necessary to support stability studies (including methods, reference materials and consumables), drug substance and drug product manufacturing, quality assurance and stability testing, characterization testing, quality control, release testing of drug substance and drug product, quality assurance, batch record review and release of product, and storage; or (b) if such Licensed Product (or the Compound contained therein) (or any precursor or intermediate thereof) is manufactured by Landos or its Affiliate, the actual, fully burdened cost of such manufacturing, including the cost of raw materials, direct labor and benefits, and freight to Landos or its Affiliate and sales and excise taxes imposed thereon, customs and duty and charges levied by government authorities, and all costs of packaging and all other reasonable and customary manufacturing-related costs specifically identifiable to the manufacture of such Licensed Product (or the Compound contained therein), but excluding the costs of idle plant capacity reserved specifically for such Licensed Product (or the Compound contained therein) based on anticipated product volumes and failed lots.", "": "" }, { "Text": "1.46 \"GCP\" or \"Good Clinical Practice\" means all applicable then-current standards for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of Clinical Trials, including, as applicable, (a) as set forth in the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Harmonised Tripartite Guideline for Good Clinical Practice (CPMP/ICH/135/95) and any other guidelines for good clinical practice for trials on medicinal products, (b) the Declaration of Helsinki (2013) as last amended at the 64th World Medical Association in October 2013 and any further amendments or clarifications thereto, (c) as set forth in the PRC Good Clinical Practice for Pharmaceuticals effective as of September 1, 2003 and its subsequent amendments, (d) U.S. Code of Federal Regulations Title 21, Parts 50 (Protection of Human Subjects), 56 (Institutional Review Boards) and 312 (Investigational New Drug Application), and (e) the equivalent applicable Laws in any relevant Region, each as may be amended and applicable from time to time and in each case, that provide for, among other things, assurance that the clinical data and reported results are credible and accurate and protect the rights, integrity, and confidentiality of trial subjects.", "": "" }, { "Text": "1.47 \"Generic Product\" means, with respect to a particular Licensed Product in a Region, any product that (a) has Regulatory Approval for use in such Region pursuant to a regulatory process governing approval of generic or interchangeable pharmaceutical products based on the then-current standards for Regulatory Approval in such Region, where such Regulatory Approval relied on or incorporated clinical data generated by either Party to this Agreement or their Affiliates or Sublicensees, or was obtained using an abbreviated, expedited or similar process, (b) during the Royalty Term is not owned or licensed by Lian under this Agreement; and (c) is sold in the same Region as the relevant Licensed Product by a Third Party that is not a Sublicensee or Affiliate of Lian and that did not purchase such product in a chain of distribution that included Lian or its Affiliates or its or their Sublicensees.", "": "" }, { "Text": "1.48 \"Global Development Plan\" has the meaning set forth in Section 3.2(b) (Global Development Plan).", "": "" }, { "Text": "1.49 \"Global Phase III Trial\" means a global registrational Phase III Trial that is included under the Global Development Plan.", "": "" }, { "Text": "1.50 \"Global Trial\" has the meaning set forth in Section 3.3(a) (Global Phase III Trial Participation).", "": "" }, { "Text": "1.51 \"GLP\" or \"Good Laboratory Practice\" means all applicable then-current standards for laboratory activities for pharmaceuticals, as set forth in the FDA's Good Laboratory Practice regulations as defined in 21 C.F.R. Part 58, the PRC Good Clinical Practice effective as of September 1, 2003, or the Good Laboratory Practice principles of the Organization for Economic Co-Operation and Development (OECD), and such standards of good laboratory practice as are required by the equivalent applicable Laws in the relevant Region and other organizations and governmental agencies in countries in which the Licensed Product is intended to be sold by the Party that is subject to such standards.", "": "" }, { "Text": "1.52 \"GMP\" or \"Good Manufacturing Practice\" means all applicable then-current standards for Manufacturing, including, as applicable, (a) the principles detailed in the U.S. Current Good Manufacturing Practices, 21 C.F.R. §§ 201, 211, 600 and 610 and all applicable FDA guidelines and requirements, (b) European Directive 2003/94/EC for medicines and investigational medicines for human use and the applicable guidelines stated in the Eudralex guidelines, (c) Pharmaceutical Good Manufacturing Practice of the PRC effective as of March 1, 2011 and its appendices, (d) the principles detailed in the applicable ICH guidelines, (e) the conduct of an inspection by a Qualified Person (as defined therein) and the execution by such Qualified Person of an appropriate certification of inspection and (f) the equivalent applicable Laws in any relevant Region, each as may be amended and applicable from time to time.", "": "" }, { "Text": "1.53 \"Governmental Authority\" means any multinational, federal, national, state, provincial, local or other entity, office, commission, bureau, agency, political subdivision, instrumentality, branch, department, authority, board, court, arbitral or other tribunal, official or officer, exercising executive, judicial, legislative, police, regulatory, administrative, or taxing authority or functions of any nature pertaining to government.", "": "" }, { "Text": "1.54 \"ICH\" means the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use.", "": "" }, { "Text": "1.55 \"Indemnified Party\" means a Person entitled to indemnification under Article 10 (Indemnification; Damages).", "": "" }, { "Text": "1.56 \"Indemnifying Party\" means a Party from whom indemnification is sought under Article 10 (Indemnification; Damages).", "": "" }, { "Text": "1.57 \"Indication\" means each separate and distinct disease, disorder, illness, health condition, or interruption, cessation or disruption of a bodily function, system, tissue type or organ, for which a separate Regulatory Approval Application is required to be filed to obtain Regulatory Approval.", "": "" }, { "Text": "1.58 \"Infringement\" has the meaning set forth in Section 7.3 (Third Party Infringement).", "": "" }, { "Text": "1.59 \"Infringement Action\" has the meaning set forth in Section 7.3(b) (Lian First Right).", "": "" }, { "Text": "1.60 \"Infringement Claim\" has the meaning set forth in Section 7.4 (Claimed Infringement).", "": "" }, { "Text": "1.61 \"Intellectual Property\" means all Patent Rights, rights to Inventions, copyrights, design rights, trademarks, trade secrets, Know-How, materials, and all other intellectual property rights (whether registered or unregistered), and all applications and rights to apply for any of the foregoing anywhere in the world.", "": "" }, { "Text": "1.62 \"Invention\" has the meaning set forth in Section 7.1(a) (Assignment Obligation).", "": "" }, { "Text": "1.63 \"Joint Know-How\" means Know-How developed or invented jointly by a Party's or its Affiliates', licensees', Sublicensees', or subcontractors' employees, agents, or independent contractors, or any persons contractually required to assign or license such Know-How to such Party or any Affiliate of such Party, on the one hand, and the other Party's or its Affiliates', licensees', Sublicensees', or subcontractors' employees, agents, or independent contractors, or any Persons contractually required to assign or license such Know-How to such Party or any Affiliate of such Party, on the other hand, in the performance of activities under this Agreement during the Term.", "": "" }, { "Text": "1.64 \"Joint Patent Right\" means any Patent Right claiming any Invention conceived jointly by employees, contractors, or agents of Lian or its Affiliates, on the one hand, and employees, contractors, or agents of Landos or its Affiliates, on the other hand.", "": "" }, { "Text": "1.65 \"JSC\" has the meaning set forth in Section 5.1 (Formation; Purposes and Principles).", "": "" }, { "Text": "1.66 \"Know-How\" means all proprietary chemical and biological materials and other tangible materials, inventions, practices, methods, protocols, formulae, knowledge, know-how, trade secrets, processes, procedures, assays, skills, experience, techniques, information, data and results of experimentation and testing, including pharmacological, toxicological and pre-clinical and clinical test data and analytical and quality control data, whether patentable or otherwise.", "": "" }, { "Text": "1.67 \"Landos\" has the meaning set forth in the Preamble.", "": "" }, { "Text": "1.68 \"Landos Indemnified Party\" has the meaning set forth in Section 10.2 (Indemnification by Lian).", "": "" }, { "Text": "1.69 \"Law\" or \"Laws\" means all laws, statutes, rules, codes, regulations, orders, decrees, judgments or ordinances of any Governmental Authority, or any license, permit or similar right granted under any of the foregoing, or any similar provision having the force or effect of law.", "": "" }, { "Text": "1.70 \"Lian\" has the meaning set forth in the Preamble.", "": "" }, { "Text": "1.71 \"Lian Indemnified Party\" has the meaning set forth in Section 10.1 (Indemnification by Landos).", "": "" }, { "Text": "1.72 \"Lian Technology\" means the Patent Rights and Know-How Controlled by Lian, its Affiliates or Sublicensees as of the effective date of termination of this Agreement, that (a) Cover any Inventions and (b) are used or applied as of the date of such termination in the Development, Manufacture or Commercialization of the Compounds or Licensed Products in the Field.", "": "" }, { "Text": "1.73 \"Lian Trademark\" has the meaning set forth in Section 4.4(c) (Trademarks).", "": "" }, { "Text": "1.74 \"Licensed Know-How\" means any and all Know-How owned or Controlled by Landos or any of its Affiliates as of the Effective Date or during the Term that is necessary or reasonably useful for the Development, Manufacture, or Commercialization of any Compound or Licensed Product in the Territory, but excluding any Joint Know-How.", "": "" }, { "Text": "1.75 \"Licensed Mark(s)\" means any Trademark(s) that Landos or its Affiliates registers with a Governmental Authority in any Region in the Territory to be used in connection with the Commercialization of a Licensed Product.", "": "" }, { "Text": "1.76 \"Licensed Patent Rights\" means any and all Patent Rights that are owned or Controlled by Landos or any of its Affiliates as of the Effective Date or at any time during the Term that (a) Cover the Licensed Know-How or (b) are otherwise necessary or reasonably useful for the Development, Manufacture, or Commercialization of any Compound or Licensed Product in the Field in the Territory. The Licensed Patent Rights as of the Effective Date are listed in Schedule 1.76 (Licensed Patents). The Licensed Patent Rights (i) include any Patent Rights claiming Product Inventions that are Controlled by Landos or its Affiliates, and (ii) exclude any Joint Patent Rights.", "": "" }, { "Text": "1.77 \"Licensed Product\" means any product containing the Compound in any formulation or dosage form, or as part of any combination that has been or is being Developed by Landos outside the Territory. For clarity, no rights or licenses are granted under this Agreement by Landos to Lian with respect to any Active Ingredient Controlled by Landos or its Affiliates included in a combination product that is not a Compound.", "": "" }, { "Text": "1.78 \"Licensed Technology\" means collectively Licensed Patent Rights, Licensed Know-How and Landos or its Affiliates' interests in the Joint Know-How and Joint Patent Rights.", "": "" }, { "Text": "1.79 \"Losses\" means damages, losses, liabilities, costs (including costs of investigation, defense), fines, penalties, taxes, expenses, or amounts paid in settlement (in each case, including reasonable attorneys' and experts' fees and expenses), in each case, resulting from an Action.", "": "" }, { "Text": "1.80 \"Manufacture\" means activities directed to manufacturing, processing, packaging, labeling, filling, finishing, assembly, quality assurance, quality control, testing, and release, shipping, or storage of any pharmaceutical or biologic product (or any components or process steps involving any product or any companion diagnostic), placebo, or comparator agent, as the case may be, including process development, qualification, and validation, scale-up, pre-clinical, clinical, and commercial manufacture and analytic development, product characterization, and stability testing, but excluding activities directed to Development or Commercialization. \"Manufacturing\" or \"Manufactured\" will be construed accordingly.", "": "" }, { "Text": "1.81 \"Marketing Authorization\" means the grant of all necessary final or conditional permits, registrations, authorizations, licenses, and approvals (or waivers) required for the Commercialization of the Licensed Product for use in the Field and in the Territory, including any Regulatory Approval for sale or marketing, and, where applicable, Pricing and Reimbursement Approvals.", "": "" }, { "Text": "1.82 \"Milestone Payments\" means Development Milestone Payments and Sales Milestone Payments.", "": "" }, { "Text": "1.83 \"Negotiation Period\" has the meaning set forth in Section 2.10 (Right of Negotiation).", "": "" }, { "Text": "1.84 \"Net Sales\" means the net sales recorded by Lian or any of its Affiliates or Sublicensees (for the purpose of this definition, \"Sublicensees\" will not include any distributors or wholesalers) (each of the foregoing Persons, a \"Selling Party\") for any Licensed Product sold to Third Parties other than Sublicensees, less the following deductions calculated in accordance with the Accounting Standards, consistently applied throughout the Territory by the relevant Selling Party to the extent allocated to such Licensed Product and actually taken, paid, accrued, allowed, included, or allocated, based on good faith estimates, in the gross sales price with respect to such sales, as set forth below: (a) cash, trade or quantity discounts, charge-back payments, and rebates actually granted to trade customers, managed health care organizations, pharmaceutical benefit managers, group purchasing organizations, and national, state, or local governments; (b) credits, rebates, or allowances actually allowed upon prompt payment or on account of claims, damaged goods, rejections, or returns of such Licensed Product, including in connection with recalls and retroactive price reductions; (c) the actual amount of any write-offs for bad debt; provided that any amount subsequently recovered will be treated as Net Sales; (d) packaging, freight, postage, shipping, transportation, warehousing, handling and insurance charges, in each case, actually allowed or paid for delivery of such Licensed Product, and any customary payments with respect to such Licensed Product actually made to wholesalers or other distributors, in each case, actually allowed or paid for distribution and delivery of Licensed Product, to the extent billed or recognized; and (e) taxes (other than income taxes), duties, tariffs, mandated contribution, or other governmental charges levied on the sale of such Licensed Product, including VAT (net of reimbursement of any value-added taxes actually received), excise taxes, and sales taxes, that the Selling Party allocates to sales of such Licensed Product in accordance with its standard policies and procedures consistently applied across its products, as applicable.", "": "" }, { "Text": "Net Sales will be calculated only once for the first bona fide arm's length sale of the Licensed Product to a Third Party that is not a Selling Party. Net Sales does not include (a) any sale of such Licensed Product to or between Lian, its Affiliates or its or their Sublicensees for further sale by such entity (but includes the subsequent sale by such entity to a Third Party that is not a Selling Party), (b) samples of Licensed Product used to promote additional Net Sales, in amounts consistent with normal business practices of a Selling Party, or (c) any use of such Licensed Product as bona fide samples, as donations, for Clinical Trials or other Development purposes, or for any expanded access program or compassionate sales or use program in accordance with applicable Law (provided, that, in each case such sales are at or below cost).", "": "" }, { "Text": "In the event that a Licensed Product is sold as a Combination Product, Net Sales, for the purposes of determining royalty payments on the Combination Product, shall mean the gross amount collected for the Combination Product less the deductions set forth in clauses (a) - (f) above, multiplied by a proration factor that is determined as follows: (i) If all Other Components of the Combination Product were sold separately during the same or immediately preceding Calendar Quarter, the proration factor shall be determined by the formula [A / (A+B)], where A is the average gross sales price of all Licensed Product components containing only the Compound as its Active Ingredient during such period when sold separately from the other component(s), and B is the average gross sales price of the Other Components during such period when sold separately from the Compound (as applicable); (ii) If the Licensed Product components containing only the Compound as its Active Ingredient are sold separately from the Other Components, but the Other Components in such Combination Product are not sold separately, then the proration factor shall be determined by the formula [A / C], where A is the average gross sales price of all Licensed Product components containing only the Compound as its Active Ingredient during such period when sold separately from the Other Components, and C is the average gross sales price of the Combination Product during such period; (iii) If the Licensed Product components containing only the Compound as its Active Ingredient are not sold separately from the Other Components, but the Other Components in such Combination Product are sold separately, then the proration factor shall be determined by the formula [( C- B) / C], where B is the average gross sales price of the Other Components included in such Combination Product if sold separately from the other component(s), and C is the average gross sales price of the Combination Product during such period; or (iv) If neither the Compound nor the Other Components included in the Combination Product were sold or provided separately during the relevant period, then the proration factor shall be agreed upon by the Parties in good faith based on the relative value contributed by each component.", "": "" }, { "Text": "1.85 \"NMPA\" means the National Medical Product Administrations of the PRC, or its successor.", "": "" }, { "Text": "1.86 \"Non-Breaching Party\" has the meaning set forth in Section 12.3(a) (Termination by Material Breach).", "": "" }, { "Text": "1.87 \"Offer\" has the meaning set forth in Section 2.10 (Right of Negotiation).", "": "" }, { "Text": "1.88 \"Offer Period\" has the meaning set forth in Section 2.10 (Right of Negotiation).", "": "" }, { "Text": "1.89 \"Other Component\" has the meaning set forth in Section 1.24 (Combination Product).", "": "" }, { "Text": "1.90 \"Party\" means either Landos or Lian; \"Parties\" means Landos and Lian, collectively.", "": "" }, { "Text": "1.91 \"Party Vote\" has the meaning set forth in Section 5.5 (Decision-Making; Escalation to Senior Officers).", "": "" }, { "Text": "1.92 \"Patent Challenge\" has the meaning set forth in Section 12.3(b) (Termination for Patent Challenge).", "": "" }, { "Text": "1.93 \"Patent Rights\" means the rights and interests in and to (a) all patents and patent applications (including provisional applications), including all divisionals, continuations, substitutions, continuations-in-part, re-examinations, re-issues, additions, renewals, extensions, confirmations, registrations, any other pre- or post-grant forms of any of the foregoing, (b) any confirmation patent or registration patent or patent of addition, utility models, patent term extensions, and supplemental protection certificates or requests for continued examinations, foreign counterparts, and the like of any of the foregoing, and (c) any and all patents that have issued or in the future issue from the foregoing patent applications, including author certificates, utility models, petty patents, innovation patents and design patents and certificates of invention.", "": "" }, { "Text": "1.94 \"Patient Commitment\" has the meaning set forth in Section 3.3(a) (Global Phase III Trial Participation).", "": "" }, { "Text": "1.95 \"Patient Shortfall\" has the meaning set forth in Section 3.3(a) (Global Phase III Trial Participation).", "": "" }, { "Text": "1.96 \"Person\" means any natural person, corporation, general partnership, limited partnership, joint venture, proprietorship or other business organization or a Governmental Authority.", "": "" }, { "Text": "1.97 \"Pharmacovigilance Agreement\" has the meaning set forth in Section 3.9 (Pharmacovigilance).", "": "" }, { "Text": "1.98 \"Phase III Trial\" means a Clinical Trial of an investigational product in subjects that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to generate data and results that can be submitted to obtain Regulatory Approval as described in 21 C.F.R. 312.21(c), or a comparable Clinical Trial prescribed by the relevant Regulatory Authority in a country other than the United States.", "": "" }, { "Text": "1.99 \"PRC\" means the People's Republic of China, which for the purposes of this Agreement, excludes Hong Kong, Macau and Taiwan.", "": "" }, { "Text": "1.100 \"Pricing and Reimbursement Approval\" means, with respect to the Licensed Product, the governmental approval, agreement, determination or decision establishing the price or level of reimbursement for such Licensed Product in a given Region in the Territory in such jurisdiction in the Field in the Territory.", "": "" }, { "Text": "1.101 \"Product Inventions\" means any Inventions that are necessary or reasonably useful for the Development, Manufacture, or Commercialization of the Compound or Licensed Products in the Field.", "": "" }, { "Text": "1.102 \"Prosecution\" or \"Prosecute\" means, with respect to a particular Patent Right, all activities associated with the preparation, filing, defense, prosecution and maintenance of such Patent Right, as well as supplemental examinations, re-examinations, reissues, applications for patent term adjustments and extensions, supplementary protection certificates and the like with respect to such Patent Right, together with the conduct of interferences, derivation proceedings, inter partes review, post-grant review, the defense of oppositions and other similar proceedings with respect to such Patent Right.", "": "" }, { "Text": "1.103 \"Region\" means each of the PRC, Macau, Hong Kong, Taiwan, Thailand, Singapore, South Korea, Cambodia, Indonesia, Myanmar, Philippines, Thailand, and Vietnam.", "": "" }, { "Text": "1.104 \"Regulatory Approval\" means the final or conditional approval of the applicable Regulatory Authority necessary for the marketing and sale of a Licensed Product in the Field in a country(ies) or Region(s), excluding separate Pricing and Reimbursement Approval that may be applicable in a Region.", "": "" }, { "Text": "1.105 \"Regulatory Approval Application\" means an application to seek regular or expedited Regulatory Approval of the Licensed Product for sale or marketing in any country(ies) or Region(s) in the Territory, as defined in the applicable Laws and filed with the Regulatory Authority of such country(ies) or Region(s).", "": "" }, { "Text": "1.106 \"Regulatory Authority\" means any multinational, federal, national, state, provincial or local regulatory agency, department, bureau or other Governmental Authority with authority over the clinical development, Manufacture, marketing or sale of the Licensed Product in a Region, including the NMPA.", "": "" }, { "Text": "1.107 \"Regulatory Exclusivity\" means, with respect to a Licensed Product in a Region, the period of time during which: (a) a Party or its Affiliates or its or their Sublicensees has been granted the exclusive legal right by a Regulatory Authority in such Region to market and sell such Licensed Product; or (b) the data and information submitted by a Party or its Affiliates or its or their sublicensees to the relevant Regulatory Authority in such Region for purposes of obtaining Regulatory Approval of such Licensed Product in such Region may not be disclosed, referenced, or relied upon in any way by a Third Party or such Regulatory Authority (including by relying upon the Regulatory Authority's previous findings regarding the safety or effectiveness of the Licensed Product) to support the Regulatory Approval of any product of a Third Party in such Region.", "": "" }, { "Text": "1.108 \"Regulatory Filing\" means any documentation comprising or relating to or supporting any filing or application with any Regulatory Authority with respect to the Licensed Product, including any documents submitted to any Regulatory Authority, including INDs, Regulatory Approval Applications, and all correspondence with any Regulatory Authority with respect to any Licensed Product (including minutes of any meetings, telephone conferences, or discussions with any Regulatory Authority).", "": "" }, { "Text": "1.109 \"Reversion License\" has the meaning set forth in Section 12.4(a) (Effects of Termination Generally).", "": "" }, { "Text": "1.110 \"Royalty Term\" has the meaning set forth in Section 6.2(b) (Royalty Term).", "": "" }, { "Text": "1.111 \"Rules\" has the meaning set forth in Section 13.2 (Arbitration).", "": "" }, { "Text": "1.112 \"Safety Data\" means any Adverse Event information from Clinical Trials and all results from non-clinical safety studies, including toxicology and carcinogenicity data (if any), with respect to the Licensed Product required by one or more Regulatory Authorities to be collected or to be reported to such Regulatory Authorities under applicable Laws, but excluding any information related to the efficacy of the Licensed Product.", "": "" }, { "Text": "1.113 \"Sales Milestone Event\" has the meaning set forth in Section 6.1(c) (Sales Milestone Payments).", "": "" }, { "Text": "1.114 \"Sales Milestone Payment\" has the meaning set forth in Section 6.1(c) (Sales Milestone Payments).", "": "" }, { "Text": "1.115 \"Sell-Off Period\" has the meaning set forth in Section 12.4(g) (Inventory).", "": "" }, { "Text": "1.116 \"Senior Officers\" means the Chief Executive Officer of each Party. If the position of any of the Senior Officers identified in this definition no longer exists due to a corporate reorganization, corporate restructuring or the like that results in the elimination of the identified position, then the applicable title of the Senior Officer set forth herein will be replaced with the title of another executive officer with responsibilities and seniority comparable to the eliminated Senior Officer, and the relevant Party will promptly provide notice of such replacement title to the other Party.", "": "" }, { "Text": "1.117 \"Sublicense\" means a grant of rights from Lian to a Sublicensee or an Affiliate under any of the rights licensed to Lian by Landos under Section 2.1 (License Grants; Right of Reference).", "": "" }, { "Text": "1.118 \"Sublicensee\" means a Third Party sublicensee to which a Party or its Affiliates has granted rights under this Agreement or a Third Party licensee of rights with respect to the Licensed Product, which rights are retained by a Party under this Agreement with respect to such Licensed Product, or any further sublicensee of such rights (regardless of the number of tiers, layers, or levels of sublicenses of such rights).", "": "" }, { "Text": "1.119 \"Supply Agreement\" has the meaning set forth in Section 4.1 (Supply Agreement).", "": "" }, { "Text": "1.120 \"Supply Failure\" means, for a given Calendar Year, that Landos has failed to supply or cause to be supplied to Lian those quantities of Licensed Product forecasted and ordered in accordance with the terms of the applicable Supply Agreement, and the cumulative shortfall of Licensed Product for such Calendar Year attributable to such failure is at least 20% of the aggregate amount so forecast to (or, if greater, ordered from) Landos for delivery in such Calendar Year.", "": "" }, { "Text": "1.121 \"Tax Withholdings\" has the meaning set forth in Section 6.5(Tax Withholding).", "": "" }, { "Text": "1.122 \"Term\" has the meaning set forth in Section 12.1 (Term).", "": "" }, { "Text": "1.123 \"Term Sheet\" means that certain non-binding (except with respect to confidentiality obligations therein) term sheet by and between Lian and Landos, dated as of March 4, 2021.", "": "" }, { "Text": "1.124 \"Terminated Product\" has the meaning set forth in Section 12.4(a) (Effects of Termination Generally).", "": "" }, { "Text": "1.125 \"Terminated Region\" has the meaning set forth in Section 12.4(a) (Effects of Termination Generally).", "": "" }, { "Text": "1.126 \"Territory\" means the PRC, Hong Kong, Macau, Taiwan, Cambodia, Indonesia, Myanmar, Philippines, Singapore, South Korea, Thailand, and Vietnam.", "": "" }, { "Text": "1.127 \"Territory-Specific Development Plan\" has the meaning set forth in Section 3.2(a) (Territory-Specific Development Plan).", "": "" }, { "Text": "1.128 \"Third Party\" means any Person other than a Party or any of its Affiliates.", "": "" }, { "Text": "1.129 \"Third Party Claim\" has the meaning set forth in Section 10.3(a) (Notice).", "": "" }, { "Text": "1.130 \"Third Party Losses\" means Losses resulting from an Action by a Third Party.", "": "" }, { "Text": "1.131 \"Trademark\" means all registered and unregistered trademarks, service marks, trade dress, trade names, logos, insignias, domain names, symbols, designs, and combinations thereof.", "": "" }, { "Text": "1.132 \"Transfer\" has the meaning set forth in Section 6.5 (Tax Withholding).", "": "" }, { "Text": "1.133 \"Trigger Notice\" has the meaning set forth in Section 2.10 (Right of Negotiation).", "": "" }, { "Text": "1.134 \"Two-Invoice Policy\" means the policy described in \"the Opinion on the Implementation of the 'Two-Invoices' System in the Procurement of Pharmaceutical Products by Public Medical Institutions (trial)\" (Guoyigaibanfa [2016] No. 4), officially released on 9 January 2017 and in any other applicable Laws that mandates public hospitals or any other purchaser of drugs in mainland China to purchase drugs from the distributor that purchases the drugs directly from the drug manufacturer, limiting the total number of invoices to two.", "": "" }, { "Text": "1.135 \"United States\" or \"U.S.\" or \"US\" means the United States and its territories, possessions and commonwealths.", "": "" }, { "Text": "1.136 \"Upstream License(s)\" means an agreement between Landos or any of its Affiliates, on the one hand, and any Third Party, on the other hand, pursuant to which Landos has (a) in-licensed any Patent Rights or Know-How owned or Controlled by such Third Party that are included as part of the Licensed Patent Rights or Licensed Know-How (to the extent necessary or useful for Lian's Development, Manufacture and Commercialization of any Licensed Product in the Territory) or (b) agreed to provisions that would require Lian to make any payments (including royalties) to any Third Party or to undertake or observe any restrictions or obligations with respect to the Development, Manufacture or Commercialization of Licensed Products in the Field.", "": "" }, { "Text": "1.137 \"Valid Claim\" means either: (a) a claim of an issued and unexpired patent that (i) has not been irrevocably or unappealably disclaimed or abandoned, or been held unenforceable, unpatentable or invalid by a decision of a court or other Governmental Authority of competent jurisdiction; and (ii) has not been admitted to be invalid or unenforceable through reissue, disclaimer, or otherwise, or (b) a claim included in a patent application that has not been cancelled, withdrawn, or abandoned, nor been pending for more than seven years from the earliest filing date to which such patent application or claim is entitled.", "": "" }, { "Text": "ARTICLE 2 LICENSE GRANTS", "": "" }, { "Text": "2.1 License Grants; Right of Reference.", "": "" }, { "Text": "(a) License Grants to Lian. Subject to the terms and conditions of this Agreement, Landos hereby grants to Lian: (i) an exclusive (even with respect to Landos and its Affiliates, subject to this Section 2.1(a) (License Grants to Lian) and Section 2.5) (Landos Right of Access and Reference), sublicensable (solely as permitted under Section 2.2(a) (Lian Right to Sublicense)), non-transferable (except as provided Section 14.1 (Assignment)), royalty-bearing license under the Licensed Technology to Develop, Manufacture, and Commercialize and otherwise, make, have made, use, offer for sale, sell, have sold, and import the Compounds and Licensed Products in the Field in the Territory; and (ii) a non-exclusive, non-transferable (except as provided Section 14.1 (Assignment)), sublicensable (solely as permitted under Section 2.2(a) (Lian Right to Sublicense)) license under the Licensed Technology to Manufacture Compounds and Licensed Products outside the Territory solely for (A) Development solely for purposes of obtaining Regulatory Approval of Licensed Products in the Field in the Territory; and (B) Commercialization of Licensed Products in the Field in the Territory. (iii) Notwithstanding the foregoing license grant under this Section 2.1(a) (License Grants to Lian), Landos retains the right under the Licensed Technology to Manufacture (or have Manufactured) Compounds and Licensed Products in the Territory solely for Development or Commercialization of Licensed Products in the Field outside the Territory.", "": "" }, { "Text": "(b) Lian Right of Access and Reference. Landos hereby grants Lian and its Affiliates and Sublicensees access to, and a right of reference with respect to, (i) the Regulatory Filings, Regulatory Approvals, Marketing Authorizations, and all corresponding documentation Controlled by Landos or its Affiliates as of the Effective Date or at any time during the Term, and (ii) all data generated by or on behalf of Landos or its Affiliates relating to the Licensed Products, including clinical and preclinical data (including any such data generated from any Clinical Trial performed by or be on behalf of Landos or its Affiliates), Safety Data and CMC Data contained or referenced in any Regulatory Filings, and all corresponding documentation Controlled by Landos or its Affiliates as of the Effective Date or at any time during the Term, in each case ((i) and (ii)) to the extent reasonably useful or necessary for Developing, seeking, and securing Regulatory Approval and Marketing Authorization for the Development, Manufacture, or Commercialization of the Licensed Products in the Field in the Territory. The foregoing rights include the right for Lian and, to the extent permitted under this Agreement, its Affiliates and Sublicensees, to make copies of and reproduce such documentation and information for the purposes set forth in this Section 2.1(b) (Lian Right of Access and Reference). Landos will promptly provide to Lian all data generated by or on behalf of it or its Affiliates from any Clinical Trial for a Licensed Product that is necessary or reasonably useful to Lian or its Affiliates or Sublicensees for securing Regulatory Approval and Marketing Authorization for the Development, Manufacture, or Commercialization of the Compound or Licensed Products in Field and in the Territory.", "": "" }, { "Text": "2.2 Sublicensing and Subcontracting.", "": "" }, { "Text": "(a) Lian Right to Sublicense. Lian will have the right to grant Sublicenses (through multiple tiers) to (i) its Affiliates and to independent contractors engaged pursuant to Section 2.3 (Performance by Independent Contractors) and to its Third Party collaboration partners, in each case, of any and all rights granted to Lian by Landos pursuant to Section 2.1 (License Grants; Right of Reference) without consent or approval of Landos, and (ii) to other Third Parties, with the prior written consent of Landos (not to be unreasonably withheld, conditioned, or delayed), but in each case ((i) and (ii)), subject to the requirements of Section 2.2(b) (Sublicense Requirements).", "": "" }, { "Text": "(b) Sublicense Requirements. Each Sublicense granted by Lian to a Third Party pursuant to Section 2.2(a) (Lian Right to Sublicense) will be in writing and will be consistent with the relevant terms and conditions set forth in this Agreement. No Sublicense will diminish, reduce or eliminate any obligation of either Party under this Agreement. Lian will be liable for any act or omission of its Sublicensees as if such Sublicensees were Lian hereunder. Without limiting the foregoing, each Sublicense granted by Lian or its Affiliates to a Sublicensee will contain (i) confidentiality and non-use provisions at least as restrictive or protective as those set forth in Section 8.1 (Confidential Information) with respect to Landos' Confidential Information, and (ii) invention ownership and assignment provisions consistent with those set forth in Section 7.1 (Ownership of Inventions).", "": "" }, { "Text": "(c) Sublicense Survival. Upon the termination of this Agreement, at the written request of any Sublicensee who is not then (i) in breach of its sublicense agreement, (ii) debarred or disqualified under applicable Laws, or (iii) engaged in any Action against Landos, Landos will enter into a direct license agreement with such Sublicensee on the same terms as this Agreement, taking into account any difference in license scope, territory and duration of sublicense grant (each a \"New License Agreement\"). Under any New License Agreement between Landos and a former Sublicensee, such Sublicensee will be required to pay to Landos the same amounts in consideration for such direct grant as Landos would have otherwise received from Lian pursuant to this Agreement on account of such Sublicensee's exploitation of the relevant Licensed Products had this Agreement not been terminated. Under such New License Agreement, Landos will not be bound by any grant of rights broader than, and will not be required to perform any obligation other than those rights and obligations contained in, this Agreement and all applicable rights of Landos set forth in this Agreement will be included in such New License Agreement. Each Sublicensee will be an intended Third Party beneficiary of this Section 2.2(c) with the right to enforce the same against Landos. At the request of Lian, Landos will issue a comfort letter directly to any potential Sublicensee confirming the terms of this Section 2.2(c).", "": "" }, { "Text": "2.3 Performance by Independent Contractors. Lian may contract or delegate any portion of its obligations hereunder to a contractor subject to the terms and condition of Section 14.8 (Affiliates, Sublicensees, and Contractors).", "": "" }, { "Text": "2.4 License Grant to Landos. Lian hereby grants Landos and its Affiliates a non-exclusive, sublicensable (through multiple tiers), royalty-free, fully paid up, perpetual, and irrevocable license under any Product Inventions invented or otherwise developed or generated during the Term by or on behalf of Lian (including its Affiliates, or any of its or their employees, Sublicensees, independent contractors, or agents) to Develop, Manufacture, and Commercialize and otherwise, make, have made, use, offer for sale, sell, have sold, and import the Compounds and Licensed Products in the Field outside the Territory.", "": "" }, { "Text": "2.5 Landos Right of Access and Reference. Lian hereby grants Landos, its Affiliates, and Sublicensees access to, and a right of reference with respect to, (a) the Regulatory Filings, Regulatory Approvals, Marketing Authorizations and all corresponding documentation Controlled by Lian, its Affiliates, or Sublicensees as of the Effective Date or at any time during the Term, and (b) all data generated by Lian or its Affiliates relating to the Licensed Products, including clinical and preclinical data, Safety Data and CMC Data contained or referenced in any Regulatory Filings, and all corresponding documentation Controlled by Lian, its Affiliates or Sublicensees as of the Effective Date or at any time during the Term. The foregoing rights include the right for Landos and, to the extent permitted under this Agreement, its Affiliates, and Sublicensees, to make copies of and reproduce such documentation and information for the purposes set forth in this Section 2.4 (License Grant to Landos). Lian will promptly provide to Landos all data generated by or on behalf of it or its Affiliates from any Clinical Trial for a Licensed Product that is necessary or reasonably useful to Landos or its Affiliates or licensees for securing Regulatory Approval and Marketing Authorization for the Development, Manufacture, or Commercialization of the Compound or Licensed Products in Field outside the Territory.", "": "" }, { "Text": "2.6 Rights in Bankruptcy.", "": "" }, { "Text": "(a) All rights and licenses now or hereafter granted by Landos to Lian under or pursuant to this Agreement, including, for the avoidance of doubt, the licenses granted to Lian pursuant to Section 2.1 (License Grants; Right of Reference) are, for all purposes of Section 365(n) of the U.S. Bankruptcy Code, licenses of rights to \"intellectual property\" as defined in the U.S. Bankruptcy Code. Upon any filing or institution of bankruptcy, reorganization, liquidation or receivership proceedings, upon the appointment of a receiver or trustee over all or substantially all property, or upon an assignment of a substantial portion of the assets for the benefit of creditors by Landos, Landos agrees that the Lian, as licensee of such rights under this Agreement, will retain and may fully exercise all of its rights and elections under the U.S. Bankruptcy Code. Without limiting the generality of the foregoing, Landos and Lian intend and agree that any sale of Landos' assets under Section 363 of the Bankruptcy Code shall be subject to Lian's rights under Section 365(n), that Lian cannot be compelled to accept a money satisfaction of its interests in the intellectual property licensed pursuant to this Agreement, and that any such sale therefore may not be made to a purchaser \"free and clear\" of Lian's rights under this Agreement and Section 365(n) without the express, contemporaneous consent of Lian. Landos acknowledges and agrees that \"embodiments\" of Intellectual Property within the meaning of Section 365(n) include laboratory notebooks, cell lines, product samples and inventory, research studies and data, all Regulatory Approvals (and all applications for Regulatory Approval) and rights of reference therein, the Licensed Know-How, Licensed Patent Rights, and all information related to the Licensed Know-How or Licensed Patent Rights. If (A) a case under the U.S. Bankruptcy Code is commenced by or against Landos, (B) this Agreement is rejected as provided in the U.S. Bankruptcy Code and (C) Lian elects to retain its rights hereunder as provided in Section 365(n) of the U.S. Bankruptcy Code, Landos (in any capacity, including debtor-in-possession) and its successors and assigns (including a trustee) will: (1) provide Lian with all such Intellectual Property (including all embodiments thereof) held by Landos and such successors and assigns, or otherwise available to them, immediately upon Lian's written request. Whenever Landos or any of its successors or assigns provides to Lian any of the Intellectual Property licensed hereunder (or any embodiment thereof) pursuant to this Section 2.6(a) (Rights in Bankruptcy), Lian will have the right to perform Landos' obligations hereunder with respect to such Intellectual Property, but neither such provision nor such performance by Lian will release Landos from liability resulting from rejection of the license or the failure to perform such obligations; and (2) not interfere with Lian's rights under this Agreement, or any agreement supplemental hereto, to such Intellectual Property (including such embodiments), including any right to obtain such Intellectual Property (or such embodiments) from another entity, to the extent provided in Section 365(n) of the U.S. Bankruptcy Code.", "": "" }, { "Text": "(b) All rights, powers and remedies of Lian provided in this Section 2.6 (Rights in Bankruptcy) are in addition to and not in substitution for any other rights, powers, and remedies now or hereafter existing at law or in equity (including the U.S. Bankruptcy Code) in the event of the commencement of a case under the U.S. Bankruptcy Code with respect to Landos. The Parties intend the following rights to extend to the maximum extent permitted by applicable Law, and to be enforceable under U.S. Bankruptcy Code Section 365(n): (A) the right of access to any Intellectual Property (and all embodiments thereof) of Landos or any Third Party that is licensed or sublicensed to Lian under this Agreement; and (B) the right to contract directly with any Third Party to complete the contracted work.", "": "" }, { "Text": "2.7 No Implied Licenses; Reservation of Rights. No rights, other than those expressly set forth in this Agreement, are granted to either Party under this Agreement, and no additional rights will be deemed granted to either Party by implication, estoppel, or otherwise, with respect to any intellectual property rights. All rights not expressly granted by either Party, or its Affiliates to the other Party under this Agreement are reserved.", "": "" }, { "Text": "2.8 Transfer of Know-How. As promptly as is reasonably practicable after the Effective Date, Landos will transfer to Lian the Licensed Know-How that exists as of the Effective Date, in the manner and pursuant to the timelines set forth in Schedule 2.8 (Know-How Transfer) attached hereto. In addition, each Party will provide updates throughout the Term, in a manner established by the JSC, to the other Party of any Know-How that such Party or its Affiliates comes to Control that is necessary or reasonably useful for the Development, Manufacture or Commercialization of Compounds and Licensed Products in the Field (such updates to be made reasonably promptly after any Calendar Quarter in which such Know-How comes into Control of the applicable Party or its respective Affiliates). Additionally, for a period of 12 months after the initial Licensed Know-How transfer, Landos will provide Lian with reasonable assistance to facilitate the successful transfer of such Licensed Know-How, such assistance to be at Lian's cost and not to exceed ten (10) hours of support per week or sixty (60) hours in the aggregate.", "": "" }, { "Text": "2.9 Exclusivity.", "": "" }, { "Text": "(a) Lian Exclusivity. Subject to the terms of this Agreement, neither Lian will, nor any of its Affiliates will, directly or indirectly, Develop, Manufacture, or Commercialize any Competitive Product anywhere in the Territory, nor collaborate with, enable, or otherwise authorize, license or grant any right to any Third Party to Develop, Manufacture, or Commercialize any Competitive Product anywhere in the Territory.", "": "" }, { "Text": "(b) Landos Exclusivity. Subject to the terms of this Agreement, neither Landos will, nor any of its Affiliates will, directly or indirectly, Develop, Manufacture, or Commercialize any Competitive Product anywhere in the Territory, nor collaborate with, enable, or otherwise authorize, license or grant any right to any Third Party to Develop, Manufacture, or Commercialize any Competitive Product anywhere in the Territory.", "": "" }, { "Text": "(c) Business Combinations. Neither Landos or its Affiliates, nor Lian or its Affiliates, will be in breach of the restrictions set forth in this Section 2.9 (Exclusivity) if such Person undergoes a Change of Control with a Third Party (together with such Third Party and its Affiliates following the closing of the applicable Change of Control transaction, the \"Acquired Party\") that is (either directly or through an Affiliate, or in collaboration with the Third Party) Developing, Manufacturing, or Commercializing one or more Competitive Products (i) at the closing of the Change of Control transaction or (ii) commences the Development, Manufacture, or Commercialization of a Competitive Product after the closing of the Change of Control transaction; and such Acquired Party may continue to Develop, Manufacture, and Commercialize such Competitive Products as long as (A) no Licensed Technology or Lian Technology is used by or on behalf of such Acquired Party or its Affiliates in connection with any subsequent Development, Manufacture, or Commercialization of such Competitive Products, and (B) such Acquired Party institutes commercially reasonable technical and administrative safeguards to ensure the requirements set forth in the foregoing clause (A) are met, including by creating \"firewalls\" between the personnel working on such Competitive Products and the personnel teams charged with working on any Compound or Licensed Product or having access to data from activities performed under this Agreement or Confidential Information of the Parties.", "": "" }, { "Text": "(d) Acquisition of a Competitive Product. Neither Landos nor Lian will be in breach of the restrictions set forth in this Section 2.9 (Exclusivity) if such Party or any of its Affiliates acquires a Competitive Product through an acquisition of, or a merger with, the whole or substantially the whole of a business or assets of another Person, so long as such Party (or its Affiliate) (i) enters into a definitive agreement with a Third Party to divest (whether by exclusive out-license or otherwise) such Competitive Product within 12 months after the closing of such acquisition or merger or (ii) terminates the further Development, Manufacture or Commercialization of such Competitive Product within 180 days after the closing of such acquisition or merger as long as, until the completion of such divestiture or termination, (A) no Licensed Technology or Lian Technology is used by or on behalf of such Party or its Affiliates in connection with any subsequent Development, Manufacture or Commercialization of such Competitive Products, and (B) such Party institutes commercially reasonable technical and administrative safeguards to ensure the requirements set forth in the foregoing clause (A) are met, including by creating \"firewalls\" between the personnel working on such Competitive Products and the personnel teams charged with working on any Compound or Licensed Product or having access to data from activities performed under this Agreement or Confidential Information of the Parties.", "": "" }, { "Text": "2.10 Right of Negotiation. During the Term, Landos grants to Lian an exclusive right of negotiation to obtain an exclusive license, under the applicable Patent Rights and Know-How Controlled by Landos, to Develop, Manufacture, and Commercialize and otherwise, make, have made, use, offer for sale, sell, have sold, and import Additional Products in the Field in the Territory (an \"Additional Product License\"), subject to the remainder of this Section 2.10 (Right of Negotiation). From time to time, Landos may present Lian with information regarding Additional Products and offer Lian an opportunity to negotiate an Additional Product License (a \"Trigger Notice\"). Licensee may exercise its exclusive negotiation right by submitting to Landos a written offer for the proposed terms of such Additional Product License, including the material financial terms and a high-level development plan for the development and commercialization of the applicable Additional Product in the Territory in one or more of the applicable indications (an \"Offer\") within ninety (90) days after receiving the Trigger Notice (the \"Offer Period\"). If Lian submits an Offer to Landos during the Offer Period, then Landos and Lian shall enter into exclusive good faith negotiations regarding the terms for such Additional Product License for a period of ninety (90) days following Landos' receipt of such Offer (the \"Negotiation Period\"). If the Parties agree on the terms for such Additional Products, then the Parties may amend this Agreement to include such Additional Product License or may enter in a separate written agreement with respect to such Additional Product License. If Lian does not submit an Offer for such Additional Product License during the Offer Period or the Parties are unable to agree on the terms of such Additional Product License or enter into an agreement with respect thereto during the Negotiation Period, then Licensee's negotiation right under this Section 2.10 (Right of Negotiation) for such Additional Product shall automatically expire, provided, however, that the restrictions under Section 2.9(b) (Landos Exclusivity) shall survive such expiration.", "": "" }, { "Text": "ARTICLE 3 DEVELOPMENT", "": "" }, { "Text": "3.1 Development Responsibilities in General.", "": "" }, { "Text": "(a) Development Diligence. Lian (directly, or through its Affiliates, Sublicensees and contractors) will use Commercially Reasonable Efforts to Develop and seek Regulatory Approval for the Licensed Products in the Territory, and Landos (directly, or through its respective Affiliates, Sublicensees and contractors) will use Commercially Reasonable Efforts to Develop and seek Regulatory Approval for the Licensed Products outside of the Territory. Without limiting the foregoing, Lian will use Commercially Reasonable Efforts to carry out any Development activities in the Territory assigned to Lian under the Territory-Specific Development Plan. Notwithstanding any provision to the contrary set forth in this Agreement, if Landos terminates this Agreement in accordance with Section 12.3(a) (Termination for Material Breach) as a result of a breach of Lian's diligence obligations under this Section 3.1(a) (Development Diligence), then such termination will be Landos' sole and exclusive remedy with respect to such breach.", "": "" }, { "Text": "(b) Development Responsibilities. Subject to the terms and conditions of this Agreement, including this Article 3 (Development) and Section 5.5 (Decision-Making; Escalation to Senior Officers), Lian will have sole authority to, at its own expense, Develop the Licensed Product for the purpose of obtaining Regulatory Approval in the Field in the Territory. Lian will be responsible for the day-to-day implementation of any Development activities for which it (or any of its Affiliates) is assigned responsibility under this Agreement (including the Development Plans).", "": "" }, { "Text": "3.2 Development Plans.", "": "" }, { "Text": "(a) Territory-Specific Development Plan. Except for the activities allocated to Lian under a Global Development Plan, all Development of Compounds and Licensed Products in the Territory will be conducted pursuant to a written a plan (the \"Territory-Specific Development Plan\"), the initial draft of which will be prepared by Lian and submitted to the JSC to review, discuss, and determine whether to approve. The Territory-Specific Development Plan will contain in reasonable detail (i) all major Development activities for the Compounds and Licensed Products (including all non-clinical studies, pre-clinical studies and Clinical Trials to be conducted in the Territory and the trial design thereof) to be conducted solely in furtherance of obtaining or maintaining Regulatory Approval of Licensed Products in the Territory, (ii) the estimated timelines for achieving such activities, and (iii) an outline of the key elements involved in obtaining Regulatory Approval of Licensed Products from all applicable Regulatory Authorities throughout the Territory. Lian will update the Territory-Specific Development Plan not less than once per Calendar Year, and either Party may propose modifications to the Territory-Specific Development Plan at any time, subject in each case to approval by the JSC. Once approved by the JSC, each update to the Territory-Specific Development Plan will become effective and supersede the then-current Territory-Specific Development Plan. In the event of any proposed change to the Development Plan as a result of any interaction with any Regulatory Authority, the JSC will meet as promptly as practicable to review and discuss any such proposed changes and determine an appropriate revision (if any) to the Territory-Specific Development Plan. If Lian is delayed in performing (or fails to perform) an obligation assigned to Lian in the Territory-Specific Development Plan as a result of Landos' failure to timely perform any of its obligations under this Agreement or the Development Plan, then the timelines for the performance of Lian's obligations under the Territory-Specific Development Plan will be extended commensurate with the delay caused by Landos.", "": "" }, { "Text": "(b) Global Development Plan. Landos' global Development of the Compounds and Licensed Products inside and outside of the Territory will be conducted pursuant to a written plan (the \"Global Development Plan\"). Prior to the first Global Trial for any Licensed Product, Landos will provide to the JSC for its review and discussion the initial Global Development Plan. The Global Development Plan will include (i) an outline of all major Development activities for the Compounds and Licensed Products to be conducted throughout the world by Landos, (ii) details and estimated timelines of the Development activities in the Territory in which Lian may participate to support each Global Phase III Trial, in accordance with Section 3.3(a) (Global Phase III Trial Participation), and (iii) details and estimated timelines of the Development activities in the Territory in which Lian may participate to support each Other Global Trial in which Lian participates, in accordance with Section 3.3(b) (Other Global Trial Participation). From time to time, Landos may propose updates to the then-current Global Development Plan for the Licensed Products to the JSC to review and discuss and, to the extent relating to activities to be conducted in the Territory, to determine whether to approve.", "": "" }, { "Text": "3.3 Global Trial Participation.", "": "" }, { "Text": "(a) Global Phase III Trial Participation. In the event that Landos decides to conduct a Global Phase III Trial for a Licensed Product, Lian will participate in such Global Phase III Trial and include Clinical Trial sites for such Global Phase III Trial in the Territory, subject to Lian obtaining priority review status from the CDE for such Global Phase III Trial and Lian's agreement to the study design and study protocol for such Global Trial in accordance with Section 3.3(c) (Study Design and Protocol). In the event that Lian participates in such Global Trial, subject to this Section 3.3(a) (Global Phase III Trial Participation) and Section 3.3(c) (Study Design and Protocol), such activities to be conducted by Lian in support of such Global Phase III Trial will be included in the Global Development Plan, and Lian will support Landos on such global development for such Global Trial by (i) including Clinical Trial sites in the Territory (with Lian having the right to determine after considering in good faith Landos' suggestions the Regions in the Territory where the Clinical Trial sites will be located), (ii) being responsible for any costs and expenses incurred by or on behalf of Lian for its participation in such Global Trial conducted in the Territory, and (iii) using Commercially Reasonable Efforts to enroll patients in the Territory equal to a minimum of 25% of the total patients in such Global Phase III Trial (the \"Patient Commitment\"). In the event that Lian participates in such a Global Phase III Trial and fails to enroll sufficient patients in the Territory to meet the Patient Commitment (the \"Patient Shortfall\"), and Landos instead enrolls patients in such Global Phase III Trial in lieu of Lian in order to meet the Patient Commitment, then Lian will reimburse Landos for the number of patients representing the Patient Shortfall that Landos so enrolls in such Global Phase III Trial (up to the Patient Commitment) based on the Average Cost Per Patient in the Territory. If Lian does not participate in a Global Phase III Trial for either of Crohn's disease or ulcerative colitis, then Lian will conduct a Clinical Trial in the Territory intended to support the Regulatory Approval for the use of the Licensed Product in the applicable disease in the Territory, and such Clinical Trial will be included in the Territory-Specific Development Plan. Additionally, in such event, Lian shall use good faith efforts to design the protocol for such Clinical Trial in a manner that would permit Landos to use clinical data generated from such Clinical Trial to support the Regulatory Approval for the use of the Licensed Product in the applicable disease in the U.S.", "": "" }, { "Text": "(b) Other Global Trial Participation. In the event that Landos decides to conduct a Global Trial for a Licensed Product, other than a Global Phase III Trial, that is primarily intended to support the Development or Regulatory Approval of any Compound or Licensed Product in the Field outside the Territory (each, an \"Other Global Trial\"), to the extent the Parties agree to Lian's participation in such Other Global Trial, then Lian will participate in such Other Global Trial and include Clinical Trial sites in the Territory, subject to (i) Lian obtaining CDE approval for the applicable activities to be conducted by Lian within the Territory under such Other Global Trial, (ii) Lian's agreement to the study design and study protocol of such Other Global Trial in accordance with Section 3.3(a) (Global Phase III Trial Participation), and (iii) Lian's approval of the endpoints of the previous phase for such Global Trial. For any Other Global Trial in which Lian agrees to participate, the Parties will prepare an update to the Global Development Plan to include the Development activities to be conducted by Lian in the Territory in support of such Other Global Trial, including the Clinical Trial sites in the Territory for such Other Global Trial, to be determined by Lian after considering in good faith Landos' suggestions thereon.", "": "" }, { "Text": "(c) Study Design and Protocol. Landos will determine the study design and study protocol for any Global Phase III Trial or Other Global Trial, and Lian will have the right to determine which patient types to enroll in the Territory for such Global Phase III Trial or Other Global Trial. Notwithstanding any provision to the contrary set forth in this Agreement, to the extent that Lian participates in any such Global Phase III Trial or Other Global Trial, Lian's obligation to participate in such Global Phase III Trial or Other Global Trial is subject to the Parties' agreement on such study design and study protocol (such approval of Lian not to be unreasonably withheld or delayed).", "": "" }, { "Text": "3.4 Development Records and Reporting.", "": "" }, { "Text": "(a) Records. Lian will maintain complete and accurate records of all work conducted by Lian in furtherance of seeking Regulatory Approval for the Licensed Product in the Field in the Territory. Such records will be maintained in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes and in accordance with applicable Laws. Lian will document all non-clinical studies and Clinical Trials for Licensed Products in formal written study records according to applicable Laws, including applicable national and international guidelines such as ICH, GCP and GLP, and shall, at Landos' written request, provide Landos English translations thereof (to the extent prepared and originated in a language other than English and subject to reimbursement by Landos of any cost of translation thereof). To the extent permissible, Landos shall have the right to review and copy such records at reasonable times and to obtain access to the original to the extent necessary or useful for regulatory or patent purposes in accordance with this Agreement.", "": "" }, { "Text": "(b) Reporting. Lian will provide a written report to the JSC for review and discussion, at least once each Calendar Quarter, in English, summarizing Lian's activities and progress related to the pursuit of Regulatory Approval for the Licensed Product in the Field in the Territory.", "": "" }, { "Text": "3.5 Development Costs. Except as set forth in Section 3.3 (Global Trial Preparation) and this Section 3.5 (Development Costs), each Party will bear 100% of the costs and expenses it incurs in connection with the Development activities conducted under the Development Plans.", "": "" }, { "Text": "3.6 Regulatory Submissions and Approvals; Communications; Meetings.", "": "" }, { "Text": "(a) Regulatory Filings and Approvals. Lian, or its relevant Affiliates or Sublicensees, will have the sole and exclusive right to file and hold all Regulatory Filings, and to apply for and maintain all Regulatory Approvals and Pricing and Reimbursement Approvals, in each case, for all Licensed Products in the Field in the Territory at Lian's cost and expense in the name of Lian or any of its Affiliates and Sublicensees. The Parties will use good faith efforts to cooperate to effectuate this Section 3.6(a) (Regulatory Filings and Approvals), and if, after the Parties' use of good faith efforts, Lian, or its Affiliate or Sublicensee is unable to become the legal and beneficial owner of the Regulatory Approvals for the Licensed Products in the Field in the Territory in order to exercise its rights and perform its obligations under this Agreement, then (i) Landos will be the legal and beneficial owner of the Regulatory Approvals for Licensed Products in the Field in the Territory, (ii) Landos will and hereby does designate Lian or its Affiliates or Sublicensees as Landos' regulatory agent and exclusive general distributor for the Licensed Products in the Field in the Territory, and (iii) to the extent later permitted by applicable Laws, Landos will promptly cooperate with Lian and its Affiliates and Sublicensees, including transferring and assigning all Regulatory Approvals and Regulatory Filings to Lian or its Affiliates or Sublicensees, to allow Lian or its Affiliates or Sublicensees to be the legal and beneficial owner of all Regulatory Approvals for Licensed Products in the Field in the Territory. Subject to the terms and conditions of this Agreement, Lian will be responsible, at its sole cost and expense, for all regulatory activities leading up to and including the obtaining of Regulatory Approvals and any Pricing and Reimbursement Approvals, as applicable, for Licensed Products in the Field from Regulatory Authorities or Governmental Authorities in the Territory. Lian will conduct such activities (and any and all regulatory activities delegated to Lian in this Agreement) (A) in its own name, if Lian is the legal and beneficial owner of the Regulatory Approvals for the Licensed Products in the Field in the Territory, or (B) as the express and authorized regulatory agent of record for Landos in the Field in the Territory, if Landos is the legal and beneficial owner of the Regulatory Approvals for the Licensed Products in the Field in the Territory, under which situation such actions will be taken on behalf of Landos and for the benefit of Lian in the Field in the Territory.", "": "" }, { "Text": "(b) Regulatory Communications. Subject to applicable Law and this Section 3.5 (Development Costs), Lian will oversee, monitor, and manage all interactions and communications with Regulatory Authorities with respect to the Licensed Products in the Field in the Territory. Lian will have final decision-making authority regarding all regulatory activities for the Licensed Products in the Field in the Territory, including the labeling strategy and the content of Regulatory Filings for Licensed Products.", "": "" }, { "Text": "(c) Regulatory Meetings. Until such time as Lian obtains Regulatory Approval for the Licensed Product in the Field in the Territory, to the extent legally permissible and practicable, Lian will provide Landos with reasonable prior written notice of all substantive meetings with Regulatory Authorities regarding the Licensed Product if permitted by applicable Law or the Regulatory Authority. Landos will have the right to request to be present as an observer at (but not to participate in, unless requested by Lian or the Regulatory Authority) all such meetings with Regulatory Authorities to the extent permitted under applicable Law, at Landos' sole cost and expense, and Lian will consider any such request in good faith.", "": "" }, { "Text": "3.7 Termination or Suspension of Clinical Trials. Notwithstanding any provision to the contrary set forth in this Agreement or the Pharmacovigilance Agreement, the Parties hereby agree that Lian may terminate or suspend any Clinical Trial relating to the Licensed Products in the Field in the Territory, and Landos may terminate or suspend any Global Trial, without the approval or consent of the JSC or the other Party, if (i) a Regulatory Authority, institutional review board or safety data review board for such Clinical Trial has required or recommended such termination or suspension or (ii) following review and discussion with the JSC, the Party seeking such termination believes in good faith that such termination or suspension is warranted because of observed safety risks to the study subjects. In either case, such Party will promptly notify the other Party in writing of such termination or suspension.", "": "" }, { "Text": "3.8 No Harmful Actions. Each Party will promptly notify the other Party of all material communications or correspondence with Regulatory Authorities with respect to any Licensed Product in such Party's territory that are (a) received by such Party or its Affiliates, Sublicensees, or other licensees (to the extent that such Party has the right to disclose such material communications or correspondence of other licensees and provided that such Party uses commercially reasonable efforts to obtain such right from such other licensees) from any Regulatory Authority or submitted by such Party, its Affiliates or other licensees to any Regulatory Authority and (b) would reasonably be expected to impact the other Party's Development, Manufacture, or Commercialization of the Licensed Products in the Field in the other Party's territory. If either Party believes that the other Party is taking or intends to take any action with respect to a Licensed Product in such other Party's territory that could have a material adverse impact upon the regulatory status of any Licensed Product in such Party's territory, then such Party will have the right to bring the matter to the attention of the JSC and the JSC will discuss in good faith a resolution to such concern.", "": "" }, { "Text": "3.9 Pharmacovigilance. Within 120 days after the Effective Date, the Parties will negotiate in good faith and finalize the actions that the Parties will employ with respect to the Licensed Products to protect patients and promote their well-being in a written pharmacovigilance agreement (the \"Pharmacovigilance Agreement\"). These responsibilities will include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as between the Parties) of Adverse Event reports and any other information concerning the safety of any Licensed Product, including recall and withdrawal responsibilities, processes and procedures. Such guidelines and procedures will be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations under applicable Law. Furthermore, such agreed procedure will be consistent with relevant ICH guidelines, except where such guidelines may conflict with existing local regulatory reporting safety reporting requirements, in which case local reporting requirement will prevail. Lian will be responsible for reporting quality complaints, Adverse Events, and safety data related to the Licensed Products in the Field to applicable Regulatory Authorities in the Territory, as well as responding to safety issues and to all requests of Regulatory Authorities relating to Licensed Products in the Field in the Territory. Landos will be responsible for reporting quality complaints, Adverse Events, and safety data related to Licensed Product to applicable Regulatory Authorities outside the Territory, as well as responding to safety issues and to all requests of Regulatory Authorities relating to Licensed Product outside the Territory. The Pharmacovigilance Agreement will also provide for a worldwide safety database to be maintained by Landos at its sole cost and expense, which worldwide safety database will be accessible by Lian and its Affiliates, Sublicensees and contractors to the full extent necessary for Lian to exercise its rights under this Agreement, comply with its obligations under this Agreement and comply with all applicable Law. Each Party will comply with its respective obligations under such Pharmacovigilance Agreement and will cause its Affiliates and Sublicensees and contractors to comply with such obligations.", "": "" }, { "Text": "ARTICLE 4 MANUFACTURE, SUPPLY, AND COMMERCIALIZATION", "": "" }, { "Text": "4.1 Supply Agreement. Within 180 days following the JSC's approval of the Territory-Specific Development Plan, the Parties will negotiate in good faith and enter into a supply agreement for the Manufacture and supply of clinical quantities of Licensed Products by Landos to Lian for use solely in connection with Clinical Trials and other Development of Licensed Products in the Field in the Territory (the \"Clinical Supply Agreement\") and, no later than 18 months prior to the date Lian anticipates its First Commercial Sale of the Licensed Products in the Territory, a supply agreement for the Manufacture and supply of commercial quantities of Licensed Products by Landos to Lian for the commercial sale and distribution of Licensed Products in the Field in the Territory (the \"Commercial Supply Agreement\" and, together with the Clinical Supply Agreement, the \"Supply Agreements\"). Unless otherwise agreed or required by applicable Laws, the Supply Agreements will specify that (a) Landos will (or will cause its Affiliates to) Manufacture and supply, and Lian will purchase from Landos, all of Lian's, its Affiliates' and Sublicensees' requirements for the Licensed Products for the Development or Commercialization (as applicable) in the Field in the Territory in their finished form and at a price equal to (a) under the Clinical Supply Agreement, 105% of the Landos' Fully Burdened Manufacturing Cost and (b) under the Commercial Supply Agreement, 110% of Landos' Fully Burdened Manufacturing Cost.", "": "" }, { "Text": "4.2 Two-Invoice Policy. The Parties agree that in the event, under the Two-Invoice Policy and tendering policies and applicable Laws in a given province in the PRC, neither Lian nor any of its Affiliates can, based on their existing qualifications, distribute the Licensed Products for such province directly or indirectly to its distributors for the PRC, then, the Parties will use reasonable efforts to discuss in good faith alternative arrangements for the distribution of the Licensed Product in such province that complies with the Two-Invoice Policy as implemented in such province and that maintains the economic interests of the Parties as agreed under this Agreement.", "": "" }, { "Text": "4.3 Manufacture Technology Transfer Option. At any time after the Effective Date, upon Lian's written request to Landos, and Landos' written consent (such consent not to be unreasonably withheld or delayed) or, in the event of a Supply Failure, upon Lian's written notice to Landos, (a) the Parties will discuss in good faith and prepare a technology transfer plan pursuant to which Landos will (i) provide access, and transfer, to Lian or its designated CMO, at Lian's sole cost (other than in the event that such transfer is following the occurrence of a Supply Failure, in which case the Parties will each bear their respective costs for such transfer) the Licensed Know-How Controlled by Landos or its Affiliates that is necessary or reasonably useful for Lian or such CMO to Manufacture the Compounds and the Licensed Products in the Field in the Territory, and (ii) provide all other reasonably necessary assistance and services to Lian (at Lian's sole cost) to enable Lian or its designated CMO to Manufacture the Compounds and Licensed Products in substantially the same manner as Landos or its Affiliates or CMOs (as applicable) Manufactures the Compounds and the Licensed Product for Lian; and (b) following agreement on such plan, Landos will perform and execute the technology transfer plan in accordance with its terms.", "": "" }, { "Text": "4.4 Commercialization.", "": "" }, { "Text": "(a) Commercialization Diligence. Upon receipt of the Marketing Authorization for a Licensed Product in the Field in a given Region in the Territory, Lian (directly, or through its Affiliates, Sublicensees or contractors) will use Commercially Reasonable Efforts to Commercialize such Licensed Product in the Field in such Region in the Territory. Lian will have sole decision-making authority and discretion with respect to Commercializing the Licensed Product in the Field in the Territory. Notwithstanding any provision to the contrary set forth in this Agreement, if Landos terminates this Agreement in accordance with Section 12.3(a) (Termination for Material Breach) as a result of a breach of Lian's diligence obligations under this Section 4.4(a) (Commercialization Diligence), then such termination will be Landos's sole and exclusive remedy with respect to such breach.", "": "" }, { "Text": "(b) Reporting Obligations. Lian will report to Landos in writing, on a quarterly basis, beginning with the Calendar Year following the first Regulatory Approval of a Licensed Product in the Field in the Territory (for the period ending December 31 of the prior Calendar Year), a summary of Lian's material Commercialization activities for such Licensed Product performed to date (or updating such report for activities performed since the last such report was given hereunder, as applicable).", "": "" }, { "Text": "(c) Trademarks.", "": "" }, { "Text": "(i) Lian will have the right to brand the Licensed Products in the Field in the Territory using Lian related Trademarks and any other Trademarks and trade names (the \"Lian Trademarks\") it determines appropriate for the Licensed Products, which branding may vary by Region or within a Region. Lian will own all rights in the Lian Trademarks and register and maintain such Lian Trademarks in the countries and regions within the Territory, where and how it determines appropriate.", "": "" }, { "Text": "(ii) Lian will also have the right to brand the Licensed Products in the Field and in the Territory using the Licensed Marks, and Lian will comply with Landos' reasonable trademark usage guidelines and quality control guidelines in effect from time to time as provided by Landos. Landos will own and retain all rights to the Licensed Marks (together with all goodwill associated therewith) in the Territory, and will prepare, file, prosecute, and maintain all Licensed Marks in the Territory at its own expense; provided, however, Landos will provide to Lian copies of all applications, submissions, communications, and correspondence intended to be sent to, sent to or received by Governmental Authorities or Third Parties in connection with such filing, prosecution, and maintenance of the Licensed Marks in the Territory so that Lian may review and comment thereon (which will be provided with sufficient advanced notice so that Lian may meaningfully review and comment, to the extent practicable), and will incorporate any reasonable comments provided by Lian with respect to such applications, submissions, communications, or correspondence. Subject to terms and conditions of this Agreement, Landos will grant and hereby grants an exclusive, sublicensable (subject to Section 2.2) (Sublicensing and Subcontracting), fully paid-up, royalty free, non-transferrable (subject to Section 14.1 (Assignment)) license under the Licensed Marks for Lian to Commercialize the Licensed Products in the Field in the Territory.", "": "" }, { "Text": "(iii) Diversion. Subject to applicable Law, each Party hereby covenants and agrees that (A) it and its Affiliates will not, and it will contractually obligate (and use Commercially Reasonable Efforts to enforce such contractual obligation) its licensees, Sublicensees and contractors not to, directly or indirectly, actively promote, market, distribute, import, sell or have sold any Licensed Product, including via the Internet or mail order, to any Third Party or to any address or Internet Protocol address or the like, in the other Party's territory, and (B) neither Party will engage, nor permit its Affiliates, Sublicensees, or contractors to engage, in any advertising or promotional activities relating to any Licensed Product for use directed primarily to customers or other buyers or users of such product located in any country, Region or jurisdiction in the other Party's territory, or solicit orders from any prospective purchaser located in any country, Region or jurisdiction in the other Party's territory.", "": "" }, { "Text": "(d) No Violation. Notwithstanding anything to the contrary contained herein, Lian (including its Affiliates, Sublicensees and contractors) will not be obligated to undertake or continue any Commercialization activities with respect to Licensed Products if Lian (or its Affiliates, Sublicensees or contractors, as applicable) reasonably determines that performance of such Commercialization activity would violate applicable Laws or infringe any Third Party Patent Rights.", "": "" }, { "Text": "ARTICLE 5 GOVERNANCE; JOINT STEERING COMMITTEE", "": "" }, { "Text": "5.1 Formation; Purposes and Principles. As soon as practicable following the Effective Date (but in no event later than 30 days after the Effective Date), Landos and Lian will form a joint steering committee (the \"JSC\") to provide oversight and to facilitate information sharing between the Parties with respect to the activities of the Parties under this Agreement.", "": "" }, { "Text": "5.2 Specific Responsibilities. In addition to its overall responsibility to provide strategic oversight and to facilitate information sharing between the Parties with respect to the activities of the Parties under this Agreement, the JSC will:", "": "" }, { "Text": "(a) share information with respect to the Development and Commercialization of the Licensed Products by Lian in the Territory and by Landos outside the Territory;", "": "" }, { "Text": "(b) coordinate and share information with respect to the Manufacture of the Licensed Products by Landos, for so long as Landos is supplying Licensed Products to Lian;", "": "" }, { "Text": "(c) keep each Party reasonably informed of the other Party's Development and Commercialization activities and interactions with Regulatory Authorities in the other Party's territory, by receiving updates from the Party conducting such activities to the extent that such activities materially impact or would reasonably be expected to materially impact the other Party's Development, Manufacture or Commercialization of the Licensed Products in the Territory; attempt to resolve in the first instance all matters between the Parties that are in dispute, in accordance with Section 5.5 (Decision-Making; Escalation to Senior Officer) and Section 13.1 (Dispute Resolution; Escalation);", "": "" }, { "Text": "(d) review, discuss, and determine whether to approve the Territory-Specific Development Plan and any proposed amendments thereto, as described in Section 3.2(a) (Territory-Specific Development Plan);", "": "" }, { "Text": "(e) review and discuss the initial Global Development Plan, and each update thereto, as described in Section 3.2(b) (Global Development Plan);", "": "" }, { "Text": "(f) review, discuss, and determine whether to approve any activities to be conducted by Lian in the Territory under the Global Development Plan, as described in Section 3.2(b) (Global Development Plan);", "": "" }, { "Text": "(g) review, discuss, and determine matters that may have a material adverse impact upon the regulatory status of the Licensed Products, as described in Section 3.9 (Pharmacovigilance); and", "": "" }, { "Text": "(h) perform such other functions as are assigned to it in this Agreement or as appropriate to further the purposes of this Agreement to the extent agreed to in writing by the Parties.", "": "" }, { "Text": "5.3 Membership. The JSC will be composed of a total of two representatives of each Party, which will be appointed by each of Landos and Lian, respectively. Each individual appointed by a Party as a representative to the JSC will be an employee of such Party with sufficient seniority and decision-making authority within the applicable Party to provide meaningful input and make decisions arising within the scope of the JSC's responsibilities, and have knowledge and expertise in the Development and Commercialization of compounds and products similar to the Compound and Licensed Products under this Agreement. The JSC may change its size from time to time by consent of its members, provided that the JSC will consist at all times of an equal number of representatives of each Party, unless otherwise agreed by the Parties in writing. Each Party may replace any of its JSC representatives at any time upon written notice to the other Party, which notice may be given by e-mail, sent to the other Party's co-chairperson. The JSC will be co-chaired by one designated representative of each Party. The co-chairperson of the JSC will cast its Party's vote on the JSC and such designee will have the authority to make decisions on behalf of such Party. Each co-chairperson will alternate being responsible for each meeting for (a) calling and conducting meetings, (b) preparing and circulating an agenda in advance of each meeting; provided, however, that the applicable co-chairperson will include any agenda items proposed by either Party on such agenda, (c) preparing minutes of each meeting that reflect the material decisions made and action items identified at such meetings promptly thereafter, and (d) sending draft meeting minutes to each member of the JSC for review and approval within 30 days after each JSC meeting. Meeting minutes issued in accordance with clause (d) of this Section 5.3 (Membership) will be deemed approved unless one or more members of the JSC objects to the accuracy of such minutes within five Business Days of receipt. The Alliance Managers will work with the chairpersons to prepare and circulate agendas and to ensure the preparation and approval of minutes. Each JSC representative will be subject to confidentiality obligations no less stringent than those in Article 8 (Confidentiality and Publicity).", "": "" }, { "Text": "5.4 Meetings; Reports. The JSC will hold meetings at least once per Calendar Quarter during the Term for so long as the JSC exists, unless the Parties agree in writing to a different frequency. No later than five Business Days prior to any meeting of the JSC (or such shorter time period as the Parties may agree), the applicable co-chairperson will prepare and circulate an agenda for such meeting. Either Party may also call a special meeting of the JSC by providing at least five Business Days prior written notice to the other Party if such Party reasonably believes that a significant matter must be addressed prior to the next scheduled meeting, in which event such Party will work with the applicable co-chairperson of the JSC and the Alliance Managers to provide the members of the JSC no later than two Business Day prior to the special meeting with an agenda for the meeting and materials reasonably adequate to enable an informed decision on the matters to be considered. The JSC may meet in person or by audio or video conference as its representatives may agree. Other representatives of the Parties, their Affiliates, or Third Parties involved in the Development, Manufacture, or Commercialization of Licensed Products may be invited by the members of the JSC to attend meetings as non-voting observers if such representatives are subject to confidentiality obligations no less stringent than those set forth in Article 8 (Confidentiality and Publicity). No action taken at a meeting will be effective unless at least one representative of each Party (which representative is not such Party's Alliance Manager) is present or participating. Neither Party will unreasonably withhold attendance of at least one representative of such Party at any meeting of the JSC for which reasonable advance notice was provided.", "": "" }, { "Text": "5.5 Decision-Making; Escalation to Senior Officers. The Parties will endeavor to reach unanimous agreement with respect to all matters within the JSC's authority. Each Party's representatives on the JSC will collectively have one vote, (the \"Party Vote\") and no action or decision will be taken by the JSC without unanimous Party Vote (i.e., the affirmative Party Vote of each Party). If the JSC is not be able to reach agreement with respect to a matter at a duly called meeting of the JSC, then either Party may refer such matter to the Senior Officers for resolution, and the Senior Officers will attempt to resolve the matter in good faith. If the Senior Officers fail to resolve such matter within 10 Business Days after the date on which the matter is referred to the Senior Officers (unless a longer period is agreed to by the Parties), then Lian will have the final decision-making authority as to (a) determining when to commence Development or Commercialization activities for the Licensed Products in a particular Region in the Territory and (b) all other matters relating to the Development, Manufacture, or Commercialization of Licensed Products in the Territory, except (with respect to sub-clause (b) only) for (i) any matter that would reasonably be expected to materially negatively impact the Development, Manufacture, or Commercialization of any Compound or Licensed Product outside the Territory, or (ii) any matter relating to Development of the Licensed Products in the Territory in relation to any Global Phase III Trial or Other Global Trial that Lian participates in that would reasonably be expected to materially negatively impact the Development, Manufacture, or Commercialization of any Compound or Licensed Product outside the Territory, in such cases ((i) – (ii)), Landos will have the final decision-making authority with respect to such matter. Subject to the foregoing sentence, Landos will have final decision-making authority over all matters relating to the Development, Manufacture, Commercialization, or other exploitation of the Compounds and Licensed Products outside the Territory. The status quo with respect to any matter that is not subject to a Party's final decision-making authority, and is not resolved at the JSC or by escalation to the Senior Officers as described above, will remain in effect until the Parties otherwise agree or exercise their respective right to submit the dispute for final resolution in accordance with Section 13.1 (Dispute Resolution; Escalation).", "": "" }, { "Text": "5.6 Limitations. Notwithstanding anything to the contrary, neither Party will have the final decision-making authority on amending or updating the Development Plan in any way that would materially alter the scope of the other Party's obligations hereunder, increase the other Party's financial obligations hereunder, or result in the disclosure of the Confidential Information of the other Party, in each case, without the other Party's prior written consent. Notwithstanding any provision of this Article 5 (Governance; Joint Steering Committee) to the contrary, the JSC will not have the authority to amend the terms or conditions of this Agreement.", "": "" }, { "Text": "5.7 Alliance Managers.", "": "" }, { "Text": "(a) Appointment. Each Party will appoint a person to oversee interactions between the Parties for all matters related to the Development and Commercialization of Licensed Products between meetings of the JSC (each, an \"Alliance Manager\"). The Alliance Managers will have the right to attend all meetings of the committees as non-voting participants and may bring to the attention of the JSC any matters or issues either Alliance Manager reasonably believes should be discussed and will have such other responsibilities as the Parties may agree in writing. Each Party may replace its Alliance Manager at any time or may designate different Alliance Managers with respect to Development and Commercialization matters, respectively, by notice in writing to the other Party.", "": "" }, { "Text": "(b) Responsibility. The Alliance Managers will have the responsibility of creating and maintaining a constructive work environment within the JSC and between the Parties for all matters related to this Agreement. Without limiting the generality of the foregoing, each Alliance Manager will: (i) provide a single point of communication within the Parties' respective organizations and between the Parties with respect to this Agreement; (ii) coordinate cooperative efforts, internal communications and external communications between the Parties with respect to this Agreement; and (iii) take such other steps as may be required to ensure that meetings of the JSC occur as set forth in this Agreement, that procedures are followed with respect to such meetings (including working with the co-chairpersons with respect to the giving of proper notice and the preparation and approval of minutes) and that relevant action items resulting from such meetings are appropriately carried out or otherwise addressed.", "": "" }, { "Text": "ARTICLE 6 FINANCIAL PROVISIONS", "": "" }, { "Text": "6.1 Upfront Payment; Milestone Payments.", "": "" }, { "Text": "(a) Upfront Payment. Subject to the terms and conditions of this Agreement, Lian will pay Landos a payment in the amount of Eighteen Million U.S. Dollars (US$ 18,000,000), which upfront payment will be due and payable to Landos within five (5) Business Days following the Effective Date.", "": "" }, { "Text": "(b) Development Milestone Payment. During the Term, Lian will notify Landos in writing of the achievement by or on behalf of Lian or its Affiliates or Sublicensees of any milestone event set forth in Table Section 6.1(b) (Development Milestone Payment) (each, a \"Development Milestone Event\") for the applicable Licensed Product promptly after the occurrence thereof, and Lian will pay Landos the milestone payment set forth in the table below (each, a \"Development Milestone Payment\") no later than 45 days after the achievement of such milestone event by Lian or its Affiliates or any Sublicensees. Each of the milestone payments set forth in Table 6.1(b) (Development Milestone Payment) is payable only upon the first achievement of such milestone by the first applicable Licensed Product to achieve such Development Milestone Event, and none of the Development Milestone Payments will be payable more than once regardless of how many times such Development Milestone Event is achieved.", "": "" }, { "Text": "Development Milestone Event", "": "" }, { "Text": "1. Dosing of first patient in the first Phase III Trial in the PRC for BT-11 in Ulcerative Colitis in the PRC", "": "" }, { "Text": "2. Dosing of first patient in the first Phase III Trial in the PRC for BT-11 in Crohn's Disease in the PRC", "": "" }, { "Text": "3. Dosing of first patient in the first Phase III Trial in the PRC for NX-13 in the PRC", "": "" }, { "Text": "4. Receipt of Marketing Authorization in the PRC for BT-11 in Ulcerative Colitis.", "": "" }, { "Text": "5. Receipt of Marketing Authorization in the PRC for BT-11 in Crohn's Disease", "": "" }, { "Text": "6. Receipt of Marketing Authorization in the PRC for NX-13 in the first Indication", "": "" }, { "Text": "Total", "": "" }, { "Text": "(c) Sales Milestone Payments. During the Term, Lian will notify Landos in writing of its achievement of each of the sales milestones below within 45 days after the end of the Calendar Quarter in which the cumulative Net Sales of all Licensed Products in the Territory first exceed the indicated Dollar value (each, a \"Sales Milestone Event\"). Lian will pay to Landos each of the milestone payments set forth below within 45 calendar days of providing notice of each Sales Milestone Event (each, a \"Sales Milestone Payment\"). Each of the milestone payments set forth in Table 6.1(c) (Sales Milestone Payments) is payable only upon the first achievement of such Sales Milestone Event and none of the Sales Milestone Payments will be payable more than once regardless of how many times such Sales Milestone Event is achieved.", "": "" }, { "Text": "Sales Milestone Event", "": "" }, { "Text": "1. Aggregate annual Net Sales of all Licensed Products in the Territory first achieves US$100 million", "": "" }, { "Text": "2. Aggregate annual Net Sales of all Licensed Products in the Territory first achieves US$200 million", "": "" }, { "Text": "3. Aggregate annual Net Sales of all Licensed Products in the Territory first achieves US$300 million", "": "" }, { "Text": "4. Aggregate annual Net Sales of all Licensed Products in the Territory first achieves US$500 million", "": "" }, { "Text": "5. Aggregate annual Net Sales of all Licensed Products in the Territory first achieves US$1 billion", "": "" }, { "Text": "Total", "": "" }, { "Text": "6.2 Royalties.", "": "" }, { "Text": "(a) Royalty Rate. Subject to the terms and conditions of this Agreement, during the applicable Royalty Term, Lian will pay to Landos a royalty on the Net Sales of all Licensed Products in the Territory that is the product of the aggregate annual Net Sales of all Licensed Products in the Territory and the applicable royalty rate in the following table, subject to the provisions of Section 6.3 (Payment Adjustments).", "": "" }, { "Text": "Portion of the Annual Net Sales of the Licensed Products in the Territory", "": "" }, { "Text": "1. The portion of aggregate annual Net Sales in the Territory less than or equal to US$100 million.", "": "" }, { "Text": "2. The portion of aggregate annual Net Sales in the Territory greater than US$100 million but less than or equal to US$200 million;", "": "" }, { "Text": "3. The portion of aggregate annual Net Sales in the Territory greater than US$200 million but less than or equal to US$300 million;", "": "" }, { "Text": "4. The portion of aggregate annual Net Sales in the Territory greater than US$300 million;", "": "" }, { "Text": "(b) Royalty Term. Royalties will be due under this Section 6.2 (Royalties) with respect to a given Licensed Product in a given Region in the Territory during the period commencing upon the First Commercial Sale of such Licensed Product in a specified Region and ending upon the latest of (i) the expiration of the last-to-expire Valid Claim of a Licensed Patent Right Covering any composition of matter (excluding formulations) of such Licensed Product that would be infringed by the sale of such Licensed Product in such Region, (ii) the expiry of the applicable Regulatory Exclusivity for such Licensed Product in such Region; or (iii) the 10th anniversary of the First Commercial Sale of such Licensed Product in such Region (such period, the \"Royalty Term\").", "": "" }, { "Text": "(c) Royalty Payments and Reports. Within 45 days following the end of each Calendar Quarter following the First Commercial Sale of a Licensed Product, Lian shall furnish to Landos a written report for the Calendar Quarter showing the Net Sales of Licensed Product sold by Lian and its Affiliates and Sublicensees in the Territory during such Calendar Quarter and the royalties payable under this Agreement for such Calendar Quarter. Lian shall pay Landos the royalty due for such Calendar Quarter calculated in accordance with this Agreement within 45 days of delivery of the written report to Landos.", "": "" }, { "Text": "6.3 Payment Adjustments. The following will apply to all royalties paid pursuant to Section 6.2(a) (Royalty Rate):", "": "" }, { "Text": "(a) Expiration of Valid Claims. On a Licensed Product-by-Licensed Product and Region by Region basis, if at any time during the Royalty Term in a given Region in the Territory, there is no Valid Claim of a Licensed Patent Right Covering a composition of matter (excluding formulation) of such Licensed Product that would be infringed by the sale of such Licensed Product in such Region, then the applicable royalty rate in effect with respect to such Licensed Product in such Region as specified in Section 6.2(a) (Royalty Rate) will be reduced by 50% for the remainder of the Royalty Term for such Licensed Product in such Region.", "": "" }, { "Text": "(b) Generic Entry. If, at any time during the Royalty Term, a Generic Product of a Licensed Product receives Regulatory Approval in any Region in the Territory in which a Licensed Product is then being sold by Lian or an Affiliate or Sublicensee, then the applicable royalty rates in effect with respect to such Licensed Product in such Region as specified in Section 6.2(a) (Royalty Rate) will be reduced by 50% for the remainder of the Royalty Term for such Licensed Product in such Region.", "": "" }, { "Text": "(c) Third Party Payments. If Lian makes a payment under any agreement with a Third Party pursuant to which Lian obtains a license or other rights under a Patent Right or other Intellectual Property owned or controlled by such Third Party in a given Region (whether by acquisition or license) that is necessary or reasonably useful to Develop, Manufacture, or Commercialize one or more Licensed Products in such Region, then Lian may offset against the Milestone Payments or royalties due to Landos for the Development and Commercialization of the Licensed Products in such Region covered by such license or rights an amount equal to 50% of the amounts paid to such Third Party under such agreement (including any upfront payments, milestone payments, and royalties), in all cases, subject to Section 6.4(d) (Cumulative Deductions).", "": "" }, { "Text": "(d) Cumulative Deductions. Notwithstanding the foregoing, in no event will the deductions set forth in Section 6.3(a) (Expiration of Valid Claims) through Section 6.3(c) (Third Party Payments) reduce (i) the royalties otherwise payable to Landos as specified in Section 6.2(a) (Expiration of Valid Claims) or (ii) with respect to the deductions set forth in Section 6.3(c) (Third Party Payments), the Milestone Payments otherwise payable to Landos as specified in Section 6.1(b) (Development Milestone Payment) and Section 6.1(c) (Sales Milestone Payments), in each case, by more than 50%. To the extent the foregoing limitation limits the reduction Lian is permitted to take during a Calendar Quarter, Lian will be entitled to carryforward the amount of the reduction Lian was unable to take during such Calendar Quarter and apply such amounts to royalties or Milestone Payments, as applicable, payable to Landos in future Calendar Quarters until such amount is applied by Lian in full.", "": "" }, { "Text": "6.4 Audits. Each Party will maintain and will cause its Affiliates and all Sublicensees to maintain, complete and accurate records in sufficient detail to permit the other Party to confirm the accuracy of the calculation of royalties, Milestone Payments, Fully Burdened Manufacturing Cost calculations, and other payments under this Agreement. Upon reasonable prior notice, but not more than once per Calendar Year and not more than once with respect to any records, such records will be available during regular business hours for a period of three years from the end of the Calendar Year to which they pertain for examination at the expense of the requesting Party by an independent certified public accountant selected by the requesting Party and reasonably acceptable to the other Party, for the sole purpose of verifying the accuracy of the financial reports and correctness of the payments furnished by the other Party pursuant to this Agreement. Any such auditor will not disclose the other Party's Confidential Information, except to the extent such disclosure is necessary to verify the accuracy of the financial reports furnished by the other Party or the amount of payments due by the other Party under this Agreement. The accountant's report will be disclosed simultaneously to both Parties, and such report will be the Confidential Information of each Party and subject to the terms of Article 8 (Confidentiality and Publicity). Any amounts shown to be owed but unpaid will be paid within 90 days from the accountant's report. Any amounts shown to have been overpaid will be refunded within 90 days from the accountant's report. The requesting Party will bear the full cost of such audit unless such audit discloses an underpayment by the other Party of more than 5% of the amount due, in which case the other Party will bear the full cost of such audit. The audit rights in this Section 6.4 (Audits) will survive the Term for three years following the effective date of any termination or expiration of this Agreement.", "": "" }, { "Text": "6.5 Tax Withholding.", "": "" }, { "Text": "(a) In the event any withholding, value added, or other tax (including any tax based on income to Landos) (\"Tax Withholdings\") is required to be withheld and deducted from payments by Lian (or its Affiliate paying on behalf of Lian) pursuant to this Agreement under applicable Laws, notwithstanding any provision to the contrary set forth under this Agreement, Lian (or its Affiliate paying on behalf of Lian) will make such deduction and withholding and will pay the remainder to Landos, and any amounts so withheld and deducted will be remitted by Lian (or its Affiliate paying on behalf of Lian) on a timely basis to the appropriate Governmental Authority for the account of Landos and Lian (or its Affiliate paying on behalf of Lian) will provide Landos reasonable evidence of the remittance within 30 days thereof and for the purposes of this Agreement, Lian will be deemed to have fulfilled all of its payment obligations to Landos with respect to such payments paid to the such Governmental Authority. Lian may satisfy its withholding, value added or other tax obligations under this Section 6.6 (Currency of Payments) through its Affiliates.", "": "" }, { "Text": "(b) If as a result of any assignment, transfer by operation of law or other transfer (A) of this Agreement by Lian to an Affiliate or Third Party, or (B) some or all of the rights and obligations under this Agreement to an Affiliate or Third Party (in each case of (A) and (B), a \"Transfer\"), then the Tax Withholdings exceeds the Tax Withholdings that would have resulted in the absence of a Transfer, then Lian shall pay to Landos such additional amounts that are necessary so that Landos receives the amounts it would have received if there were no such Transfer.", "": "" }, { "Text": "(c) Without limiting Section 6.6(a), the Parties agree to cooperate with one another and use reasonable efforts to reduce or eliminate Tax Withholdings or similar obligations in respect of payments made by Lian to Landos under this Agreement. Landos shall provide Lian any tax forms that may be reasonably necessary in order for Lian or its Affiliates not to withhold tax or to withhold tax at a reduced rate under an applicable bilateral income tax treaty. Each Party shall provide the other Party and its Affiliates with reasonable assistance to enable the recovery, as permitted by applicable Laws, of withholding taxes, VAT or similar obligations resulting from payments made under this Agreement, such recovery to be for the benefit of the Party bearing such withholding tax or VAT. Specifically, in the event that any tax has been withheld upon a payment made under this Agreement and been remitted by Lian to a Governmental Authority, if requested by Landos and if, and for so long as, the Parties acting in good faith mutually agree that there is a reasonable prospect of successfully obtaining a refund of such tax, then Lian shall, at Landos' sole cost and expense, seek a refund of such tax from the proper Governmental Authority. Landos agrees to reasonably cooperate with Lian and its Affiliates in the pursuit of such tax refund (including, if required by applicable Laws or by the applicable Governmental Authority, permitting Lian to seek such tax refund in Landos' name and participating in any application or appeal that requires that Landos be the party applying for such tax refund, solely with Landos 'prior written consent); provided that, Landos agrees to assume responsibility for direct payment of lawyers' and other advisors' fees and any other costs associated with seeking such refund.", "": "" }, { "Text": "6.6 Manner of Payment; Currency of Payments. All payments owed by Lian under this Agreement will be made by wire transfer in immediately available funds to a bank and account designated in writing by Landos. All amounts payable and calculations under this Agreement will be in Dollars. As applicable, Net Sales and any royalty reductions will be translated into Dollars using the average of the applicable daily foreign exchange rates published in the Wall Street Journal (or any other qualified source that is acceptable to both Parties) for the last day of each month of the Calendar Quarter in which such Net Sales occurred.", "": "" }, { "Text": "6.7 Late Payments. Without limiting any other rights or remedies available to Landos hereunder, any late payment by Lian will bear interest, to the extent permitted by Laws, at an annual rate of two percent above the prime rate set by the Wall Street Journal on the date payment was due or the highest rate permitted by applicable Law (whichever is lower), computed from the dated such payment was due until the date Lian makes the payment, with such interest compounded quarterly.", "": "" }, { "Text": "ARTICLE 7 INTELLECTUAL PROPERTY OWNERSHIP, PROTECTION AND RELATED MATTERS", "": "" }, { "Text": "7.1 Ownership of Inventions.", "": "" }, { "Text": "(a) Ownership of Inventions; Cross License of Product Inventions. Ownership will follow inventorship for any and all inventions, Know-How, developments, or discoveries, whether patentable or non-patentable, invented or otherwise developed or generated by either Party alone (including its Affiliates, or any of its or their employees, Sublicensees, independent contractors, or agents) or jointly by both Parties (including jointly by their Affiliates, or any of its or their employees, Sublicensees, independent contractors, or agents) in the performance of a Party's obligations or exercise of its rights under this Agreement (collectively, \"Inventions\") and such ownership will be determined based on the principles of inventorship in accordance with United States patent Laws.", "": "" }, { "Text": "(b) Assignment Obligation. Each Party will assign, and will cause its Affiliates to assign, its rights, and cause all employees of such Party or Affiliate who perform activities for such Party or Affiliate under this Agreement to be under an obligation to assign their rights, in any Patent Rights and Know-How, whether or not patentable, resulting therefrom to such Party or Affiliate to effectuate the terms and conditions set forth in Section 7.1(a) (Assignment Obligation). With respect to any activities of a Party or its Affiliate or exercise of its or their rights under this Agreement that are subcontracted to a Person that is not an employee, the Party or such Affiliate retaining such subcontractor will include in the applicable subcontract an assignment to such Party or such Affiliate of all rights in Patent Rights and Know-How made by such subcontractor resulting from such activities or exercise of its rights, and in any event will include in the applicable subcontract a license to such Party or Affiliate that is sublicensable (through multiple tiers) to the other Party under this Agreement, of any Patent Rights and Know-How made by such contractor or subcontractor resulting from such activities.", "": "" }, { "Text": "7.2 Prosecution and Maintenance of the Licensed Patent Rights and Joint Patent Rights.", "": "" }, { "Text": "(a) In the Territory. As between the Parties, Landos will have the first right, at its expense, to Prosecute the Licensed Patent Rights and Joint Patent Rights in all Regions in the Territory, at Landos' sole cost and expense. Landos will keep Lian reasonably informed of all steps with regard to and the status of such Prosecution of such Patent Rights, including by providing Lian with (i) copies of all correspondence and material communications it sends to or receives from any patent office or agency in the Territory relating to such Patent Rights, (ii) a draft copy of all applications, in each case ((i) and (ii)), sufficiently in advance of filing or response to permit reasonable review and comment by Lian, and (iii) a copy of applications as filed, together with notice of its filing date and serial number. Before Landos submits any material filing, including a new patent application, or response to such patent authorities with respect to any Licensed Patent Rights or Joint Patent Rights, Landos will provide Lian with a reasonable opportunity to review and comment on such filing or response and will incorporate any reasonable comments or suggestions provided by Lian regarding the Prosecution of such Licensed Patent Rights or Joint Patent Rights under this Section 7.2(a) (In the Territory).", "": "" }, { "Text": "(b) Step-In Right. If Landos elects not to continue to Prosecute a given Patent Right within the Licensed Patent Rights or Joint Patent Rights in the Territory pursuant to Section 7.2(a) (In the Territory), then Landos will give Lian notice thereof within a reasonable period (but not less than 90 days) prior to allowing such Patent Rights to lapse or become abandoned or unenforceable, and Lian will have the right, but not the obligation, to assume the Prosecution of such Patent Rights in such Region, including paying any required fees to maintain such Patent Rights in such Region, all at Lian's sole expense and through patent counsel or agents of its choice. Upon transfer of Landos' responsibility for Prosecuting any of the Patent Rights to Lian under this Section 7.2(b) (Step-In Right), (i) Landos will promptly deliver to Lian copies of all necessary files related to the Patent Rights with respect to which responsibility has been transferred and will take all actions and execute all documents reasonably necessary for Lian to assume such Prosecution, and (ii) such Patent Right shall no longer extend the Royalty Term pursuant to Section 6.2(b) (Royalty Term). Thereafter, Lian will keep Landos reasonably informed of the status of such Prosecution of such Patent Rights.", "": "" }, { "Text": "(c) Cooperation. Each Party will, and will cause its Affiliates to, reasonably cooperate, with the other Party with respect to the Prosecution of Licensed Patent Rights and Joint Patent Rights pursuant to this Section 7.2 (Prosecution and Maintenance of the Licensed Patent Rights and Joint Patent Rights), including with respect to obtaining patent term restoration, supplemental protection certificates or their equivalents, and patent terms extension with respect to the Licensed Patent Rights and Joint Patent Rights in any Region where applicable.", "": "" }, { "Text": "7.3 Third Party Infringement.", "": "" }, { "Text": "(a) Notice. Each Party will promptly notify the other in writing if such Party becomes aware of any suspected, threatened or actual infringement by any Third Party of any Licensed Technology or Joint Patent Right arising from the making, using, offering to sell, selling, or importing of a product in the Field in the Territory that could be competitive with a Licensed Product, and, in each case, will provide the other Party with all evidence in such Party's possession or control supporting such infringement or unauthorized use or misappropriation (each, an \"Infringement\").", "": "" }, { "Text": "(b) Lian First Right. As between the Parties, Lian will have the first right, but not the obligation, using counsel of its choosing and at its sole expense, to institute any infringement, misappropriation, or other appropriate Action against any Infringement of the Licensed Technology or Joint Patent Rights (any such Action, an \"Infringement Action\") in the Field in the Territory. Landos shall have the right, at its own cost and expense, to be represented in any Infringement Action by counsel of its own choice. Lian will notify Landos of its decision to commence an Infringement Action, will keep Landos apprised in writing of any such Infringement Action, and will consider Landos' reasonable interests and requests regarding such Infringement Action.", "": "" }, { "Text": "(c) Landos Right. If Lian fails to commence a suit to enforce the Licensed Technology or Joint Patent Rights against such Infringement (or to settle or otherwise secure the abatement of such Infringement) within (i) 180 days after its receipt or delivery of notice under Section 7.3 (Third Party Infringement), or (ii) 30 days before the time limit, if any, set forth in the appropriate Laws for the filing of such actions, whichever comes first, or ceases to diligently pursue such Infringement Action, then Landos will have the right, but not the obligation, at its own expense to institute such Infringement Action against the applicable Third Party infringer(s).", "": "" }, { "Text": "(d) Cooperation. In any Infringement Action brought under the Licensed Technology or Joint Patent Rights pursuant to Section 7.3(b) (Lian First Right) and Section 7.3(c) (Landos Right), each Party will, and will cause its Affiliates to, reasonably cooperate with each other, in good faith, relative to the other Party's efforts to protect the Licensed Technology and Joint Patent Rights, and will join such suit as a party, if requested by the other Party. Furthermore, the Party initiating any Infringement Action pursuant to Section 7.3(b) (Lian First Right) or Section 7.3(c) (Landos Right) will consider in good faith all reasonable and timely comments from the other Party on any proposed arguments asserted or to be asserted in litigation related to the enforcement or defense of any such Patent Rights. Neither Party will have the right to settle any Infringement Action under this Section 7.3 (Third Party Infringement) in a manner that diminishes the rights or interests of the other Party under this Agreement without the consent of such other Party, which consent will not be unreasonably withheld.", "": "" }, { "Text": "(e) Allocation of Recoveries. Any settlements, damages or monetary awards recovered by either Party pursuant to any Infringement Action will (i) first be allocated to reimbursing the Parties for their reasonable out-of-pocket expenses in making such recovery (which amounts will be allocated pro rata if insufficient to cover the totality of such expenses), and (ii) (A) if Lian initiated such Infringement Action, any remaining recoveries will be retained by Lian and will be deemed to be Net Sales of the applicable Licensed Product(s) in the applicable Calendar Quarter or (B) if Landos initiated such Infringement Action, then any remaining recoveries will be shared sixty percent (60%) to Landos and forty percent (40%) to Lian.", "": "" }, { "Text": "7.4 Claimed Infringement. Each Party will promptly notify the other Party if a Third Party brings any Action alleging patent infringement by Lian or Landos or any of their respective Affiliates or Sublicensees with respect to the Development, Manufacture or Commercialization of any Licensed Product or Joint Patent Rights (any such Action, an \"Infringement Claim\") in the Territory. Lian will have the right, but not the obligation, to control the defense and response to any such Infringement Claim in the Territory with respect to Lian's activities, at Lian's sole cost and expense, and Landos will have the right, at its own expense, to be represented in any such Infringement Claim in the Territory by counsel of its own choice. Landos will have the sole right, but not the obligation, to control the defense and response to any such Infringement Claim with respect to Landos' activities, including any such Infringement Claim in the Territory or outside of the Territory. Upon the request of the Party controlling the response to the Infringement Claim, the other Party will reasonably cooperate with the controlling Party in the reasonable defense of such Infringement Claim. The other Party will have the right to consult with the controlling Party concerning any Infringement Claim and to participate in and be represented by independent counsel in any associated litigation. If the Infringement Claim is brought against both Parties, then each Party will have the right to defend against the Infringement Claim. The Party defending an Infringement Claim under this Section 7.4 (Claimed Infringement) will (a) consult with the other Party as to the strategy for the prosecution of such defense, (b) consider in good faith any comments from the other Party with respect thereto and (c) keep the other Party reasonably informed of any material steps taken and provide copies of all material documents filed, in connection with such defense. The Party controlling the defense against an Infringement Claim will have the right to settle such Infringement Claim on terms deemed reasonably appropriate by such Party, provided, that, neither Party will have the right to settle any Infringement Claim under this Section 7.4 (Claimed Infringement) in a manner that diminishes the rights or interests of the other Party under this Agreement without the consent of such other Party, which consent will not be unreasonably withheld.", "": "" }, { "Text": "7.5 Common Interest. All information exchanged between the Parties regarding the Prosecution, enforcement, and defense, of Licensed Patent Rights and Joint Patent Rights under this Article 7 (Intellectual Property Ownership, Protection and Related Matters) will be deemed Confidential Information of the disclosing Party. In addition, the Parties acknowledge and agree that, with regard to such Prosecution, enforcement, and defense, the interests of the Parties as collaborators and licensor and licensee are to obtain the strongest patent protection possible, and as such, are aligned and are legal in nature. The Parties agree and acknowledge that they have not waived, and nothing in this Agreement constitutes a waiver of, any legal privilege concerning the Patent Rights under this Article 7 (Intellectual Property Ownership, Protection and Related Matters), including privilege under the common interest doctrine and similar or related doctrines. Notwithstanding any provision to the contrary set forth in this Agreement, to the extent a Party has a good faith belief that any information required to be disclosed by such Party to the other Party under this Article 7 (Intellectual Property Ownership, Protection and Related Matters) is protected by attorney-client privilege or any other applicable legal privilege or immunity, such Party will not be required to disclose such information, and the Parties will in good faith cooperate to agree upon a procedure (including entering into a specific common interest agreement, disclosing such information on a \"for counsel eyes only\" basis or similar procedure) under which such information may be disclosed without waiving or breaching such privilege or immunity.", "": "" }, { "Text": "ARTICLE 8 CONFIDENTIALITY AND PUBLICITY", "": "" }, { "Text": "8.1 Confidential Information.", "": "" }, { "Text": "(a) Confidentiality Obligation. During the Term and for a period of 10 years after any termination or expiration of this Agreement, each Party agrees to, and will cause its Affiliates and Sublicensees and contractors to, keep in confidence and not to disclose to any Third Party, or use for any purpose, except to exercise its rights or perform its obligations under this Agreement, any Confidential Information of the other Party, without the prior written consent of such disclosing Party. The existence and terms of this Agreement are the Confidential Information of each Party.", "": "" }, { "Text": "(b) Permitted Disclosures. Each Party agrees that it and its Affiliates will provide or permit access to the other Party's Confidential Information only to the receiving Party's employees, consultants, advisors, licensees, collaboration partners, and Sublicensees, and to the employees, consultants and advisors of the receiving Party's Affiliates, in each case on a need to know basis who are subject to obligations of confidentiality and non-use with respect to such Confidential Information no less stringent than the obligations of confidentiality and non-use of the receiving Party pursuant to this Section 8.1 (Confidential Information). Each Party will remain responsible for any failure by its Affiliates, licensees, collaboration partners, or Sublicensees, and its and its Affiliates' respective employees, consultants and advisors, to treat such Confidential Information as required under this Section 8.1 (Confidential Information) as if such Affiliates, employees, consultants, advisors, licensees, collaboration partners, and Sublicensees were parties directly bound to the requirements of this Section 8.1 (Confidential Information).", "": "" }, { "Text": "(c) Confidentiality Limitation. Notwithstanding any provision to the contrary set forth in this Agreement, each Party may use and disclose the other Party's Confidential Information as follows: (i) under appropriate written confidentiality and non-use obligations no less stringent than those in this Agreement, to its Affiliates, bona fide potential or actual collaboration partners, licensors, Sublicensees, licensees, or strategic partners and to employees, directors, agents, consultants, and advisers of any other Third Parties, (ii) to its financial advisors, attorneys and accountants, bona fide actual or potential acquisition partners, financing sources or investors and underwriters on a need to know basis, in each case under appropriate confidentiality and non-use obligations (which may include professional ethical obligations) no less stringent than those in this Agreement; provided, however, that each Party will remain responsible for any failure by any of the foregoing individuals to treat such Confidential Information as required under Section 8.1 (Confidential Information) as if such individuals were parties directly bound to the requirements of this Section 8.1 (Confidential Information), or (iii) as required by any court or other governmental body or as otherwise required by applicable Laws (including any such disclosures as are required by a Regulatory Authority in connection with seeking Regulatory Approval, Pricing and Reimbursement Approval, import authorization for any Licensed Product in the Territory, or the rules or regulations of the United States Securities and Exchange Commission or similar Regulatory Authority in a country other than the United States or of any stock exchange or listing entity (including in connection with the public sale of securities)); provided, that, notice is promptly given to the other Party and the disclosing Party cooperates with reasonable requests from the other Party to seek a protective order or other appropriate remedy to protect the Confidential Information. Notwithstanding any provision to the contrary contained in this Article 8 (Confidentiality and Publicity), Confidential Information that is permitted or required to be disclosed will remain otherwise subject to the confidentiality and non-use provisions of Section 8.1(b) (Permitted Disclosures) and this Section 8.1(c) (Confidentiality Limitation). If either Party concludes that a copy of this Agreement must be filed with the United States Securities and Exchange Commission or similar Governmental Authority in a country other than the United States, then such Party will, a reasonable time prior to any such filing, provide the other Party with a copy of such agreement showing any provisions hereof as to which the Party proposes to request confidential treatment, will provide the other Party with an opportunity to comment on any such proposed redactions and to suggest additional redactions, and will take such Party's reasonable comments into consideration before filing such agreement and use reasonable efforts to have terms identified by such other Party afforded confidential treatment by the applicable Regulatory Authority.", "": "" }, { "Text": "(d) Secrecy of Licensed Know-How. Without limiting the generality of Section 8.1(a) (Confidentiality Obligation), during the Term the receiving Party will protect, and will cause, to the extent applicable, its Affiliates and Sublicensees, and its and their respective officers, directors, employees, and agents to protect, the secrecy and confidentiality of the Licensed Know-How and unpublished Patent Rights using at least the same degree of care as it uses to prevent the disclosure of its own other confidential information of like importance and in any event a reasonable duty of care.", "": "" }, { "Text": "(e) Residual Knowledge. The Parties acknowledge the practical difficulty of policing the use of information inadvertently retained in the unaided memory of a receiving Party or its Affiliates and its and their officers, directors, employees, and agents who have had rightful access to the Confidential Information of the disclosing Party (\"Residual Knowledge\"), and as such each Party agrees that the receiving Party will not be liable for the inadvertent use (without reference to any Confidential Information of the disclosing Party) by any of its or its Affiliates' officers, directors, employees, or agents of the Residual Knowledge that is inadvertently retained in the unaided memory of such officer, director, employee, or agent; provided that such officer, director, employee, or agent has not been directed to or otherwise intentionally memorized or retained such Residual Knowledge for use other than as explicitly permitted under this Agreement. The receiving Party acknowledges and agrees that any use made by the receiving Party of any such Residual Knowledge is on an \"as is, where is\" basis and at its sole risk, with all faults and all representations and warranties disclaimed by the disclosing Party.", "": "" }, { "Text": "8.2 Publicity. The Parties acknowledge the importance of supporting each other's efforts to publicly disclose results and significant developments regarding the Licensed Product in the Field in the Territory, and each Party may make such disclosures from time to time, subject to the terms and conditions of this Agreement, including this Section 8.2 (Publicity). Such disclosures may include achievement of milestones, significant events in the Development process with respect to Licensed Products, or Commercialization activities with respect to Licensed Products.", "": "" }, { "Text": "(a) On a date to be agreed by the Parties, the Parties will jointly issue a press release regarding the signing of this Agreement. Except as set forth in the preceding sentence and for disclosures permitted in accordance with Section 8.1(b) (Permitted Disclosures), whenever either Party elects to make any public disclosure regarding milestones or other significant events in the Development or Commercialization of the Licensed Products in the Field in the Territory, it will first notify the other Party of such planned press release or public announcement and provide a draft for review no less than five days in advance of issuing such press release or making such public announcement (or, with respect to press releases and public announcements that are required by applicable Laws, with as much advance notice as possible under the circumstances if it is not possible to provide notice at least five days in advance). Each Party will have the right to review and approve any such planned press release or public announcement proposed by the other Party with respect to Licensed Products in the Field in the Territory, or that includes Confidential Information of the other Party. In such case, (i) the reviewing Party will attempt to provide such approval as soon as reasonably possible and will not unreasonably withhold such approval; (ii) the reviewing Party will provide explanations of its disapproval of such press release; and (iii) a Party desiring to make such public disclosure may issue such press release or public announcement without such prior review by the other Party if (A) the contents of such press release or public announcement have previously been made public other than through a breach of this Agreement by such Party, and (B) such press release or public announcement is consistent with the previously issued press release or other publicly available information. The Party reviewing a press release provided under this clause (i) of this Section 8.2(a) (Publicity) will review and approve or disapprove such press release within two Business Days after its receipt thereof.", "": "" }, { "Text": "(b) In the event that either Party proposes to publish or present the results of Development or Commercialization carried out on the Licensed Product, including any oral presentation or abstract that contain clinical data or pertain to results of Clinical Trials or other studies, such publication or presentation will be subject to the prior review by the other Party for protection of such other Party's Confidential Information. Each Party will provide to the other Party the opportunity to review a draft of any proposed publication that covers the results of Development or Commercialization of Licensed Products during the Term, and the submitting Party will remove from such proposed publication any Confidential Information of the other Party as reasonably requested by the other Party.", "": "" }, { "Text": "ARTICLE 9 REPRESENTATIONS AND WARRANTIES; CERTAIN COVENANTS", "": "" }, { "Text": "9.1 Mutual Representations and Warranties. Each Party represents and warrants to the other Party that, as of the Effective Date:", "": "" }, { "Text": "(a) Organization. It is a corporation duly organized, validly existing, and in good standing under the Laws of the jurisdiction of its organization, and has all requisite power and authority, corporate or otherwise, to execute, deliver, and perform this Agreement.", "": "" }, { "Text": "(b) Authority. It has full right, power and authority to enter into this Agreement and to perform its respective obligations under this Agreement, it has the right to grant to the other the licenses and sublicenses granted pursuant to this Agreement, and this Agreement and the performance by such Party of this Agreement do not violate such Party's charter documents, bylaws or other organizational documents.", "": "" }, { "Text": "(c) Consents. Except for any Marketing Authorizations, Regulatory Approvals, Regulatory Filings, Manufacturing approvals or similar approvals necessary for the Development, Manufacture or Commercialization of Licensed Products, all necessary consents, approvals and authorizations of all Governmental Authorities and other Persons required to be obtained by it in connection with the execution, delivery and performance of this Agreement have been obtained.", "": "" }, { "Text": "(d) No Conflict. It is not under any obligation, contractual or otherwise, to any Person that would affect the diligent and complete fulfillment of obligations under this Agreement and the execution and delivery of this Agreement by such Party, and the performance of such Party's obligations under this Agreement (as contemplated as of the Effective Date) and the licenses and sublicenses to be granted by such Party pursuant to this Agreement (i) do not conflict with or violate any requirement of Laws applicable to such Party, (ii) do not conflict with or violate any order, writ, judgment, injunction, decree, determination, or award of any court or governmental agency presently in effect applicable to such Party, and (iii) do not conflict with, violate, breach or constitute a default under, or give rise to any right of termination, cancellation or acceleration of, any contractual obligations of such Party or any of its Affiliates.", "": "" }, { "Text": "(e) Enforceability. This Agreement is a legal and valid obligation binding upon it and is enforceable against it in accordance with its terms, subject to the general principles of equity and subject to bankruptcy, insolvency, moratorium, judicial principles affecting the availability of specific performance and other similar Laws affecting the enforcement of creditors' rights generally.", "": "" }, { "Text": "9.2 Additional Representations and Warranties of Landos. Landos represents and warrants to Lian that, as of the Effective Date:", "": "" }, { "Text": "(a) Licensed Patent Rights. All Licensed Patent Rights as of the Effective Date are listed in Schedule 1.76 (Licensed Patents). Landos is the sole and exclusive owner of the Licensed Patent Rights, all of which are free and clear of any claims, liens, charges or encumbrances. Except as otherwise noted in Schedule 1.76 (Licensed Patents), all Licensed Patent Rights owned or Controlled by Landos have been filed and Prosecuted in good faith in the patent offices in accordance with applicable Laws, and all applicable fees have been paid on or before the due date for payment. All issued Licensed Patent Rights are valid, subsisting, and enforceable. Landos does not own or hold any Patent Rights that would be necessary or reasonably useful for the Development, Manufacture, or Commercialization of the Licensed Products in the Territory other than the Licensed Patent Rights.", "": "" }, { "Text": "(b) Licensed Know-How. Landos owns or Controls the Licensed Know-How, and has the right to grant the licenses under the Licensed Know-How to Lian on and the terms set forth in this Agreement. Landos has the right to use and disclose (in each case, under appropriate circumstances of confidentiality) the Licensed Know-How free and clear of any claims, liens, charges or encumbrances.", "": "" }, { "Text": "(c) Licensed Technology. Landos has not granted to any Third Party, including any academic organization or agency, any license, option or other rights to research, Develop, Manufacture, use or Commercialize the Compounds or the Licensed Products in the Territory. No Third Party has any license, option or other rights or interest in or to the Licensed Technology other than the rights that are expressly reserved or contingent under this Agreement.", "": "" }, { "Text": "(d) Licensed Marks. Landos owns or Controls the Licensed Marks, and has the right to grant the licenses under the Licensed Marks to Lian on the terms set forth in this Agreement.", "": "" }, { "Text": "(e) Delivery of Documentation. Prior to the Effective Date, Landos has made available to Lian true, complete, and correct copies of: (i) all existing material Regulatory Filings in its possession and control relating to Licensed Products, (ii) all material adverse information with respect to the safety and efficacy of the Licensed Products in Landos' or its Affiliates' (to the extent applicable, in accordance with Section 2.1(b) (Lian Right of Access and Reference)) possession and control, and (iii) all material data and results relating to the Development of the Licensed Products in Landos' or its Affiliates' (to the extent applicable, in accordance with Section 2.1(b)) (Lian Right of Access and Reference).", "": "" }, { "Text": "(f) Third Party Challenges. There are no claims, judgments, or settlements against, or amounts with respect thereto, made against Landos or any of its Affiliates relating to the Licensed Patent Rights or the Licensed Know-How, and no written claim or litigation has been received by Landos or its Affiliates or, to Landos' knowledge, threatened by any Person (i) alleging that the Licensed Patent Rights are invalid or unenforceable, (ii) asserting the misuse of any of the Licensed Patent Rights, (iii) challenging Landos' Control of the Licensed Patent Rights (i.e., alleging that a Third Party has a right or interest in or to the Licensed Technology), or (iv) alleging misappropriation of the Know-How of any Third Party used in the Development, Manufacture or Commercialization of Licensed Products by or on behalf of Landos prior to the Effective Date.", "": "" }, { "Text": "(g) Non-Infringement of Third Party IP. To Landos' knowledge, the Development, Manufacture, or Commercialization of the Licensed Product in the Territory does not infringe any Patent Right or misappropriate or otherwise violate or misappropriate any Know-How of any Person (in the case of pending Patent Rights, evaluating them as if issued). No written claim of infringement of the Patent Rights or misappropriation of the Know-How of any Third Party has been received by Landos, or to Landos' knowledge, threatened, against Landos, any of its Affiliates or its or their Sublicensees with respect to the Development, Manufacture or Commercialization of Licensed Products. To Landos' knowledge, the practice by Lian under the Licensed Technology or the Development, Manufacture, or Commercialization of the Compounds or Licensed Products as contemplated under this Agreement will not infringe, misappropriate or otherwise violate any Intellectual Property of any Third Party.", "": "" }, { "Text": "(h) Absence of Litigation. There are no judgments or settlements against or owed by Landos or its Affiliates or Sublicensees, or, to Landos' knowledge, pending litigation against Landos or its Affiliates or Sublicensees, or litigation threatened against Landos or its Affiliates or Sublicensees, in each case, related to Compounds or Licensed Products, including any such litigation any relating to any Regulatory Filings, Regulatory Approvals, or Marketing Authorizations Controlled by Landos, its Affiliates or its Sublicensees.", "": "" }, { "Text": "(i) Maintenance of Regulatory Filings, Good Laboratory, and Clinical Practices. Landos maintains control over all Regulatory Filings pertaining to the Licensed Products in the Field in the Territory. Landos and its Affiliates and Sublicensees have generated, prepared, maintained, and retained all Regulatory Filings and Marketing Authorizations in its control that are required to be maintained or retained pursuant to and in material compliance with applicable Laws, and have conducted in material compliance with applicable Laws, including GLP and GCP all Development of Licensed Products in the Field conducted prior to the Effective Date.", "": "" }, { "Text": "(j) Confidentiality of Know-How. Landos has taken commercially reasonable measures consistent with industry practices to protect the secrecy, confidentiality, and value of all Licensed Know-How. To Landos' knowledge, the Licensed Know-How existing as of the Effective Date has been kept confidential or has been disclosed to Third Parties only under terms of confidentiality.", "": "" }, { "Text": "(k) Assignment of Third Party Rights; Third Party Consents.", "": "" }, { "Text": "(i) Landos has obtained from each of its employees and agents, and from the employees and agents of its Affiliates, who are performing Development activities under the Global Development Plan for Licensed Products, rights to any and all Know-How created by such employees and agents in the course of such activities that relates to Licensed Products, such that Lian will, by virtue of this Agreement, receive from Landos, without payments beyond those required by Article 6 (Financial Provisions), all licenses and other rights granted to Lian under this Agreement.", "": "" }, { "Text": "(ii) Each Person who has or has had any ownership rights in or to any Licensed Patent Rights purported to be owned solely by Landos, has assigned and has executed an agreement assigning its entire rights, title, and interests in and to such Licensed Patent Rights to Landos, and to Landos' knowledge, no current officer, employee, agent, or consultant of Landos or any of its Affiliates is in violation of any term of any assignment or other agreement, in each case, regarding the protection of the Licensed Patent Rights.", "": "" }, { "Text": "(iii) Prior to the Effective Date, Landos has obtained all consents from Third Parties necessary to grant Lian the licenses and rights Landos purports to grant to Lian under this Agreement.", "": "" }, { "Text": "(l) Statements to Regulatory Authorities. Neither Landos nor any of its Affiliates, nor, to Landos' knowledge, its Sublicensees nor any of its or their respective officers, employees, or agents has made an untrue statement of material fact or fraudulent statement to any Regulatory Authority with respect to the Development or Commercialization of Licensed Products, or failed to disclose a material fact required under applicable Laws to be disclosed to any Regulatory Authority with respect to the Development or Commercialization of Licensed Products.", "": "" }, { "Text": "(m) Compliance with Laws. All of the studies, tests, and pre-clinical and Clinical Trials of Licensed Products conducted prior to, or being conducted as of, the Effective Date by or on behalf of Landos have been and are being conducted in all material respects in accordance with applicable Laws.", "": "" }, { "Text": "(n) Upstream Licenses. As of the Effective Date, Landos owns all Licensed Technology and does not Control any such Licensed Technology pursuant to any Upstream License.", "": "" }, { "Text": "(o) No Other Disclosures. To Landos' knowledge, there is no material information, including regarding any safety, efficacy, or regulatory issues, within Landos' Control that has not been disclosed to Lian and that would materially adversely affect the acceptance, or the subsequent approval, by any Regulatory Authority of any Regulatory Filing for a Licensed Product in the Field and in the Territory.", "": "" }, { "Text": "9.3 No Conflict. During the Term, Landos and its Affiliates will not grant any interest in the Licensed Technology that is inconsistent with the terms and conditions of this Agreement.", "": "" }, { "Text": "(a) Additional Representations, Warranties and Covenants of Lian. Lian hereby covenants to Landos that neither Lian nor any of its Affiliates or Sublicensees, will employ or use the services of any Person who is debarred or disqualified under laws in the Territory comparable with the United States Federal Food, Drug and Cosmetic Act, 21 U.S.C. §§301 et seq., or the Public Health Service Act, 42 U.S.C. §§262 et seq. in connection with activities relating to any Licensed Product; and in the event that Lian becomes aware of the debarment or disqualification or threatened debarment or disqualification of any Person providing services to Lian or any of its Affiliates with respect to any activities relating to any Licensed Product, Lian will immediately (but in any event no later than two (2) Business Days) notify Landos in writing and Lian will cease, or cause its Affiliate to cease (as applicable), employing, contracting with, or retaining any such Person to perform any services relating to any Licensed Product.", "": "" }, { "Text": "9.4 Compliance with Laws. Each Party shall, and shall ensure that its Affiliates and their respective Sublicensees will, comply in all respects with all applicable Laws (including Anti-Corruption Laws), including in the Development, Manufacturing, and Commercialization of Licensed Products and performance of its obligations under this Agreement, including the ICH, GCP, GLP and any Regulatory Authority and Governmental Authority health care programs having jurisdiction in such Party's respective territory, each as may be amended from time to time.", "": "" }, { "Text": "9.5 NO OTHER WARRANTIES. EXCEPT AS EXPRESSLY STATED IN SECTION 9.1 (MUTUAL REPRESENTATIONS AND WARRANTIES) AND SECTION 9.2 (ADDITIONAL REPRESENTATIONS AND WARRANTIES OF LANDOS), NEITHER PARTY MAKES ANY REPRESENTATIONS OR EXTENDS ANY WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, STATUTORY OR OTHERWISE, INCLUDING WARRANTIES OF TITLE, NON-INFRINGEMENT OR NON-MISAPPROPRIATION OF THIRD PARTY INTELLECTUAL PROPERTY WITH RESPECT TO THE LICENSED PRODUCT, VALIDITY, ENFORCEABILITY, MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.", "": "" }, { "Text": "ARTICLE 10 INDEMNIFICATION; DAMAGES", "": "" }, { "Text": "10.1 Indemnification by Landos. Landos will defend, indemnify and hold harmless Lian, its Affiliates and their respective directors, officers, employees and agents (each, a \"Lian Indemnified Party\"), from, against and in respect of any and all Third Party Losses incurred or suffered by any Lian Indemnified Party to the extent arising from or relating to: (a) any breach of any representation or warranty made by Landos in this Agreement, or any breach by Landos of any obligation, covenant, or agreement in this Agreement; (b) the gross negligence or intentional misconduct of Landos or any of its Affiliates, (sub)licensees (other than Lian), or contractors, or any of their respective directors, officers, employees, or agents, in performing Landos' obligations or exercising Landos' rights under this Agreement; (c) activities conducted by or on behalf of Landos or its Affiliates or Sublicensees or contractors related to the Development, Manufacture, or Commercialization of Licensed Products anywhere in the world prior to the Effective Date; and (d) the Development, Manufacture, or Commercialization of the Licensed Products by or on behalf of Landos, any of its Affiliates, Sublicensees (other than Lian), or contractors outside the Territory; provided, however, that Landos' obligations pursuant to this Section 10.1 (Indemnification by Landos) will not apply to the extent such Third Party Losses result from Third Party Losses for which Lian has an obligation to indemnify Landos pursuant to Section 10.2 (Indemnification by Lian).", "": "" }, { "Text": "10.2 Indemnification by Lian. Lian will defend, indemnify and hold harmless Landos, its Affiliates, and each of their respective directors, officers, employees and agents (each, a \"Landos Indemnified Party\") from, against and in respect of any and all Third Party Losses incurred or suffered by any Landos Indemnified Party to the extent arising from or relating to: (a) any breach of any representation or warranty made by Lian in this Agreement, or any breach by Lian of any obligation, covenant, or agreement in this Agreement, (b) the gross negligence or intentional misconduct of, or violation of Laws by, Lian, any of its Affiliates, Sublicensees, or contractors, or any of their respective directors, officers, employees, or agents, in performing Lian's obligations or exercising Lian's rights under this Agreement, or (c) the Development, Manufacture, or Commercialization of the Licensed Product by or on behalf of Lian or its Affiliates or Sublicensees (other than Landos) or contractors; provided, however, that Lian's obligations pursuant to this Section 10.2 (Indemnification by Lian) will not apply to the extent such Third Party Losses result from Third Party Losses for which Landos has an obligation to indemnify Lian pursuant to Section 10.1 (Indemnification by Landos).", "": "" }, { "Text": "10.3 Claims for Indemnification.", "": "" }, { "Text": "(a) Notice. An Indemnified Party entitled to indemnification under Section 10.1 (Indemnification by Landos) or Section 10.2 (Indemnification by Lian) will give prompt written notification to the Indemnifying Party from whom indemnification is sought of the commencement of any Action by a Third Party for which indemnification may be sought (a \"Third Party Claim\") or, if earlier, upon the assertion of such Third Party Claim by a Third Party; provided, however, that failure by an Indemnified Party to give notice of a Third Party Claim as provided in this Section 10.3(a) (Notice) will not relieve the Indemnifying Party of its indemnification obligation under this Agreement, except and only to the extent that such Indemnifying Party is materially prejudiced as a result of such failure to give notice.", "": "" }, { "Text": "(b) Defense. Within 30 days after delivery of a notice of any Third Party Claim in accordance with Section 10.3(a) (Notice), the Indemnifying Party may, upon written notice thereof to the Indemnified Party, assume control of the defense of such Third Party Claim with counsel reasonably satisfactory to the Indemnified Party. If the Indemnifying Party does not assume control of such defense, then the Indemnified Party may control such defense (with counsel reasonably selected by the Indemnified Party and approved by the Indemnifying Party, such approval not to be unreasonably withheld). The Party not controlling such defense may participate therein at its own expense.", "": "" }, { "Text": "(c) Cooperation. The Party controlling the defense of any Third Party Claim will keep the other Party advised of the status and material developments of such Third Party Claim and the defense thereof and will reasonably consider recommendations made by the other Party with respect thereto. The other Party will reasonably cooperate with the Party controlling such defense and its Affiliates and agents in defense of the Third Party Claim, with all out-of-pocket costs of such cooperation to be borne by the Party controlling such defense.", "": "" }, { "Text": "(d) Settlement. The Indemnified Party will not agree to any settlement of such Third Party Claim without the prior written consent of the Indemnifying Party, which consent will not be unreasonably withheld. The Indemnifying Party will not agree to any settlement of such Third Party Claim or consent to any judgment in respect thereof that does not include a complete and unconditional release of the Indemnified Party from all liability with respect thereto or that imposes any liability or obligation on the Indemnified Party (other than a monetary obligation on the Indemnifying Party), without the prior written consent of the Indemnified Party, which will not be unreasonably withheld (unless such compromise or settlement involves (i) any admission of legal wrongdoing by the Indemnified Party, (ii) any payment by the Indemnified Party that is not indemnified under this Agreement, or (iii) the imposition of any equitable relief against the Indemnified Party (in which case, (i) through (iii), the Indemnified Party may withhold its consent to such settlement in its sole discretion)).", "": "" }, { "Text": "(e) Mitigation of Loss. Each Indemnified Party will take and will procure that its Affiliates and Sublicensees take all such reasonable steps and actions as are necessary or as the Indemnifying Party may reasonably require in order to mitigate any Third Party Claims (or potential losses or damages) under this Article 10 (Indemnification; Damages). Nothing in this Agreement will or will be deemed to relieve any Party of any common law or other duty to mitigate any losses incurred by it.", "": "" }, { "Text": "10.4 Insurance. Each Party, at its own expense, will maintain liability insurance (or self-insure) with respect to its activities under this Agreement in an amount consistent with industry standards. Each Party will provide a certificate of insurance (or evidence of self-insurance) evidencing such coverage to the other Party upon request. Without limiting the foregoing, during the Term and thereafter for the period of time required below, each Party will maintain on an ongoing basis comprehensive general liability insurance policies which are consistent with normal business practices of prudent companies similar situated in such Party's territory. Not later than 30 days following receipt of written request from a Party, the other Party will provide to the requesting Party a certificate of insurance evidencing such insurance policies. Each Party will maintain such insurance or self-insurance coverage without interruption during the Term and for a period of three years thereafter, and, if applicable, will provide certificates or letters evidencing such insurance coverage without interruption as reasonably requested during the period of time for which such coverage must be maintained. Each Party will be provided at least 30 days' prior written notice of any cancellation or material decrease in the other Party's insurance coverage limits described above. Notwithstanding the foregoing, either Party's failure to maintain adequate insurance will not relieve that Party of its obligations set forth in this Agreement.", "": "" }, { "Text": "ARTICLE 11 LIMITATION OF LIABILITY", "": "" }, { "Text": "11.1 NO CONSEQUENTIAL OR PUNITIVE DAMAGES. EXCEPT AS SET FORTH IN SECTION 11.2 (EXCLUSION FROM LIABILITY LIMITATION), NEITHER PARTY NOR ANY OF ITS AFFILIATES OR AFFILIATED ENTITIES WILL BE LIABLE FOR INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL, EXEMPLARY, OR PUNITIVE DAMAGES ARISING OUT OF THIS AGREEMENT OR THE EXERCISE OF ITS RIGHTS OR THE PERFORMANCE OF ITS OBLIGATIONS HEREUNDER, OR ANY LOST PROFITS ARISING OUT OF THIS AGREEMENT, IN EACH CASE, HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, WHETHER IN CONTRACT, TORT, NEGLIGENCE, BREACH OF STATUTORY DUTY, OR OTHERWISE, REGARDLESS OF ANY NOTICE OF SUCH DAMAGES.", "": "" }, { "Text": "11.2 EXCLUSION FROM LIABILITY LIMITATION. THE LIMITATIONS AND DISCLAIMER SET FORTH IN SECTION 11.1 (NO CONSEQUENTIAL OR PUNITIVE DAMAGES) WILL NOT APPLY TO A CLAIM: (A) FOR GROSS NEGLIGENCE OR WILLFUL MISCONDUCT; (B) FOR A BREACH OF SECTION 2.9 (EXCLUSIVITY), SECTION 9.2(a) (LICENSED PATENT RIGHTS), ARTICLE 8 (CONFIDENTIALITY AND PUBLICITY); OR (C) FOR INDEMNIFIABLE LOSSES PURSUANT TO SECTION 10.1 (INDEMNIFICATION BY LANDOS) OR SECTION 10.2 (INDEMNIFICATION BY LIAN), AS APPLICABLE.", "": "" }, { "Text": "ARTICLE 12 TERM AND TERMINATION", "": "" }, { "Text": "12.1 Term. Unless terminated earlier in accordance with this Article 12 (Term and Termination), this Agreement will become effective as of the Effective Date and will continue in full force, on a Licensed Product-by-Licensed and Region-by-Region basis, until the expiration of the Royalty Term applicable to such Licensed Product and such Region (the \"Term\").", "": "" }, { "Text": "12.2 Paid-Up License Upon End of Royalty Term. Upon the expiration of the Royalty Term for a given Licensed Product in a given Region in the Territory, the licenses and rights of reference granted to Lian pursuant to Section 2.1 (License Grants; Rights of Reference) will become perpetual, irrevocable, fully paid-up, royalty free, fully sublicensable, and transferable with respect to such Licensed Product in such Region.", "": "" }, { "Text": "12.3 Early Termination.", "": "" }, { "Text": "(a) Termination for Material Breach. Upon (i) any material breach of this Agreement by Landos or (ii) any material breach of this Agreement by Lian (the Party so allegedly breaching being the \"Breaching Party\"), the other Party (the \"Non-Breaching Party\") will have the right, but not the obligation, to terminate this Agreement by providing written notice to the Breaching Party within 30 days' in the case of a payment breach, or 90 days' in the case of any other material breach, which notice will, in each case (A) expressly reference this Section 12.3(a) (Termination for Material Breach), (B) reasonably describe the alleged breach that is the basis of such termination, and (C) clearly state the Non-Breaching Party's intent to terminate this Agreement if the alleged breach is not cured within the applicable cure period. If such breach relates solely to one or more Licensed Products or Regions of the Territory, then the non-breaching Party will have the right to terminate this Agreement solely with respect to such Licensed Product(s) or Region(s), as applicable. Notwithstanding the foregoing, if such material breach, by its nature, is curable, but is not reasonably curable within the applicable cure period, then such cure period will be extended by up to an additional 90 days if the Breaching Party provides a reasonable written plan for curing such breach to the Non-Breaching Party and uses reasonable efforts to cure such breach in accordance with such written plan. In addition, if the Breaching Party disputes (A) whether it has materially breached this Agreement, (B) whether such material breach is reasonably curable within the applicable cure period, or (C) whether it has cured such material breach within the applicable cure period, then the dispute will be resolved pursuant to Article 13 (Dispute Resolution), and the applicable cure period will be tolled during the pendency of such dispute resolution procedure.", "": "" }, { "Text": "(b) Termination for Patent Challenge. Except to the extent the following is unenforceable under the Laws of a particular jurisdiction in the Territory or as otherwise provided in this Section 12.3(b) (Termination for Patent Challenge), Landos may terminate this Agreement upon written notice to Lian if Lian, its Affiliates, or Sublicensees, individually or in association with any other person or entity, commences a legal action challenging the validity, enforceability, or scope of any Licensed Patent Rights in a court or other governmental agency of competent jurisdiction in the Territory, including a reexamination or opposition proceeding (a \"Patent Challenge\"); provided that, if Lian or its Affiliate or Sublicensee withdraws (or causes to be withdrawn) such Patent Challenge within 60 days after being requested to do so by Landos in writing (which termination notice will be deemed a request), then Landos will have no right to terminate this Agreement pursuant to this Section 12.3(b) (Termination for Patent Challenge). In addition, and notwithstanding any provision to the contrary set forth in this Agreement, Landos may not terminate this Agreement pursuant to this Section 12.3(b) (Termination for Patent Challenge) (i) if Lian or its Affiliate or Sublicensee is required by legal process to be joined as a party in any Patent Challenge by a Third Party, or (ii) with respect to: (A) any affirmative defense or other validity, enforceability, or non-infringement challenge, whether in the same action or in any other agency or forum of competent jurisdiction, advanced by Lian, or any of its Affiliates or Sublicensees in response to any claim or action brought in the first instance by, or on behalf of, Landos, (B) any Patent Challenge to the extent commenced by a Third Party that after the Effective Date acquires or is acquired by Lian or any of its Affiliates or its or their business or assets, whether by stock purchase, merger, asset purchase, or otherwise; provided that such proceeding commenced prior to the closing of such acquisition, or (C) any Patent Challenge that is commenced by a Sublicensee; provided that Lian demands that such Sublicensee withdraw such Patent Challenge promptly after Lian becomes aware of such Patent Challenge and terminates the sublicense agreement with the applicable Sublicensee if such Sublicensee does not withdraw such Patent Challenge within 60 days after receipt of notice from Lian.", "": "" }, { "Text": "(c) Termination for Insolvency. Subject to Section 2.6 (Rights in Bankruptcy), either Party may terminate this Agreement upon delivery of written notice to the other Party if (i) such other Party files in any court or agency pursuant to any statute or regulation of any jurisdiction a petition in bankruptcy or insolvency or for reorganization or similar arrangement for the benefit of creditors or for the appointment of a receiver or trustee of such other Party or its assets, (ii) such other Party is served with an involuntary petition against it in any insolvency proceeding and such involuntary petition has not been stayed or dismissed within 90 days of its filing, or (iii) such other Party makes an assignment of substantially all of its assets for the benefit of its creditors.", "": "" }, { "Text": "(d) Termination by Lian for Convenience. Lian may, upon 180 days' prior written notice to Landos, terminate this Agreement for convenience, without cause, and for any or no reason, on a Licensed Product-by-Licensed Product basis.", "": "" }, { "Text": "12.4 Effects of Termination.", "": "" }, { "Text": "(a) Effects of Termination Generally. Upon any termination of this Agreement with respect to one or more Licensed Products (a \"Terminated Product\") or Regions (a \"Terminated Region\"), then the Parties' rights, licenses and obligations under this Agreement will terminate with respect to the applicable Terminated Product or Terminated Region and neither Party will have any further rights or obligations under this Agreement from and after the effective date of termination with respect to the applicable Terminated Product or Terminated Region, except as set forth in this Section 12.4 (Effects of Termination).", "": "" }, { "Text": "(b) Winding Down of Activities. If there are any on-going Development or Commercialization activities with respect to a Terminated Product or Terminated Region at termination or expiration of this Agreement, then the Parties will negotiate in good faith and adopt a plan to wind-down such activities in an orderly fashion or, at Landos' election and unless prohibited by any Regulatory Authority or applicable Law, promptly transition such activities from Lian to Landos or its designee, with due regard for patient safety and the rights of any subjects that are participants in any Clinical Trials of the Licensed Products, and take any actions it deems reasonably necessary or appropriate to avoid any human health or safety problems and, with respect to any Clinical Trial transitioned to Landos or its designee, to minimize any disruption to such Clinical Trial, and in compliance with all applicable Law.", "": "" }, { "Text": "(c) License Grant to Landos.", "": "" }, { "Text": "(i) Upon termination of this Agreement, Lian, on behalf of itself and its Affiliates hereby grants (effective on delivery of the notice of termination) to Landos a worldwide, irrevocable, perpetual, transferable, exclusive license under the Product Inventions and Patent Rights controlled by Lian that cover any such Product Inventions, in each case, in existence as of the applicable effective date of termination, to Develop, Manufacture, and Commercialize Compounds and Licensed Products in the Field in the Territory (the \"Reversion License\"). If any rights granted by Lian under the Reversion License are Controlled by Lian or its Affiliates or Sublicensees pursuant to an agreement with a Third Party, then Landos will pay all amounts due under any such agreement to the extent reasonably allocable to Landos' exercise of the rights granted thereunder.", "": "" }, { "Text": "(ii) Effective upon any termination of this Agreement in all Regions of the Territory, if, as of the effective date of termination, the Terminated Product has achieved First Commercial Sale in any Region in the Territory, then Lian will assign and transfer (and if unable to assign and transfer, exclusively license) to Landos any Trademarks owned or Controlled by Lian that are specific to such Terminated Product for the purpose of Commercializing such Terminated Product, together with all goodwill associated with the specific Trademarks. If this Agreement is terminated with respect to one or more, but not all, Regions in the Territory, then Lian will grant an exclusive license to Landos under any Trademarks in the Terminated Region owned or Controlled by Lian or its Affiliates that are specific to such Terminated Product for the purpose of Commercializing such Terminated Product in the Terminated Region.", "": "" }, { "Text": "(iii) If Landos or its or their Affiliates or Sublicensees exercises the Reversion License or the rights granted pursuant to Section 12.4(h) (Transfer of Regulatory Filings and Regulatory Approvals) and this Agreement has been terminated by Lian pursuant to Section 12.3(a) (Termination for Material Breach), then Landos will pay to Lian, in consideration of the rights granted to Landos, an amount to be negotiated by the Parties, taking into account the relative contribution of the Parties to the Development of the Licensed Product(s) and the potential commercial value of the Licensed Product(s) given its or their state of development.", "": "" }, { "Text": "(d) Discontinuation of JSC. Upon termination of this Agreement in its entirety, the JSC will cease to exist; provided, however, that if this Agreement is terminated with respect to one or more Terminated Products or Terminated Regions only, then the JSC will continue with respect to the non-terminated Licensed Products or Regions only.", "": "" }, { "Text": "(e) Accrued Obligations. Expiration or termination of this Agreement for any reason will not release either Party from any obligation or liability that, on the effective date of such expiration or termination, has already accrued to the other Party or that is attributable to a period prior to such expiration or termination.", "": "" }, { "Text": "(f) Survival. This Section 12.4(f) (Survival), the provisions set forth in the following Sections, as well as, to the extent applicable, any other Sections or defined terms referred to in such Sections or Articles or necessary to give them effect, will survive any expiration or termination of this Agreement in its entirety: Articles 6 (solely to the extent any payment obligations have accrued prior to expiration or termination), 8, 10, 11, 13 and 14 and Sections 2.4, 2.5, 2.6, 2.7, 3.4(a), 7.1, 9.5, 12.2 and 12.4. Furthermore, any other provisions required to interpret the Parties' rights and obligations under this Agreement, including applicable definitions in Article 1 (Definitions), will survive to the extent required. Except as otherwise expressly provided in this Agreement, including this Section 12.4(f) (Survival), any licenses granted under this Agreement will terminate upon expiration or termination of this Agreement in its entirety or solely with respect to a Terminated Product or Terminated Region, as the case may be, for any reason.", "": "" }, { "Text": "(g) Inventory.", "": "" }, { "Text": "(i) Sell-Off Period. Lian will have the right, for a period of 180 days following termination of this Agreement in any Region, to sell or otherwise dispose of any Licensed Products in such terminated Regions, as applicable, on hand at the time of such termination or in the process of Manufacturing (the \"Sell-Off Period\").", "": "" }, { "Text": "(ii) Landos Buy-Back. Upon expiration of any Sell-Off Period in any Region, Landos will have the right to purchase all of Lian's and its Affiliates' remaining inventory of Licensed Products held as of the effective date of expiration of such Sell-Off Period at a price equal to (A) the price paid by Lian to Landos for such inventory of Licensed Products, if supplied by Landos or (B) if Manufactured by Lian, Lian's fully burdened manufacturing cost, with such cost calculated as described in the definition of \"Fully Burdened Manufacturing Cost\" set forth in Section 1.45 (Fully Burdened Manufacturing Cost) (mutatis mutandis).", "": "" }, { "Text": "(h) Transfer of Regulatory Filings and Regulatory Approvals. Following the effectiveness of any termination of this Agreement pursuant to Section 12.3 (Early Termination), after Landos' written request, Lian will, to the extent permitted under applicable Laws, and at Landos' sole cost and expense (unless the applicable termination giving rise to Landos' rights under this Section 12.4(h) (Transfer of Regulatory Filings and Regulatory Approvals) was initiated by Landos pursuant to Section 12.3 (Early Termination), in which case such transfer will be at Lian's sole cost and expense), assign and transfer to Landos all Regulatory Filings, filings for Pricing and Reimbursement Approval and Marketing Authorizations for Licensed Products that are held by or owned by Lian or its Affiliates or Sublicensees as of the effective date of termination, with respect to the terminated Region, as the case may be.", "": "" }, { "Text": "(i) Return of Confidential Information. Within 30 days after the effective date of termination (but not expiration) of this Agreement in its entirety, each Party will, and cause its Affiliates to (i) destroy, all tangible items solely comprising, bearing or containing any Confidential Information of the other Party that are in such first Party's or its Affiliates' possession or Control, and provide written certification of such destruction, or (ii) prepare such tangible items of the other Party's Confidential Information for shipment to such other Party, as such other Party may direct, at the first Party's expense; provided, however, that, in any event, (A) each Party may retain copies of the Confidential Information of the other Party to the extent necessary to perform its obligations or exercise its rights that survive expiration or termination of this Agreement; and (B) each Party may retain copies of the Confidential Information of the other Party for its legal archives.", "": "" }, { "Text": "ARTICLE 13 DISPUTE RESOLUTION", "": "" }, { "Text": "13.1 Dispute Resolution; Escalation. The Parties recognize that disputes as to certain matters arising out of or in connection with this Agreement may arise from time to time. It is the objective of the Parties to establish procedures to facilitate the resolution of disputes arising out of or in connection with this Agreement in an expedited manner by mutual cooperation. To accomplish this objective, any and all disputes between the Parties arising out of or in connection with this Agreement (other than matters within the purview of the JSC, which will be resolved in accordance with Section 5.5 (Decision-Making; Escalation to Senior Officers)), will first be referred to the Senior Officers for resolution. The Senior Officers will attempt to resolve the matter in good faith. If the Senior Officers fail to resolve such matter within 15 Business Days after the date on which the matter is referred to the Senior Officers (unless a longer period is agreed to by the Parties), then either Party may submit the dispute for final resolution by binding arbitration in accordance with Section 13.2 (Arbitration).", "": "" }, { "Text": "13.2 Arbitration. Except as set forth in Section 12.4(c) (License Grant to Landos) and this Section 13.2 (Arbitration), each dispute, difference, controversy or claim arising in connection with or related or incidental to, or question occurring under, this Agreement or the subject matter hereof that cannot be resolved pursuant to Section 13.1 (Dispute Resolution; Escalation) will be referred to and finally resolved by arbitration in accordance with the International Chamber of Commerce (the \"Rules\") by an arbitral tribunal composed of three arbitrators, all of whom will have previous judicial experience and significant experience in the biopharmaceutical industry, with each Party appointing one arbitrator and the third arbitrator to be selected by agreement of the two arbitrators appointed by the Parties. If the two initial arbitrators are unable to select a third arbitrator within 30 days, then the third arbitrator will be appointed in accordance with ICC rules. The foregoing arbitration proceedings may be commenced by either Party by notice to the other Party. Unless otherwise agreed by the Parties, all such arbitration proceedings will be held in New York, New York. All arbitration proceedings will be conducted in the English language. The arbitrators will consider grants of equitable relief and orders for specific performance as co-equal remedies along with awards of monetary damages. The arbitrators will have no authority to award punitive damages. The allocation of expenses of the arbitration, including reasonable attorney's fees, will be determined by the arbitrators, or, in the absence of such determination, each Party will pay its own expenses. The Parties hereby agree that the arbitrators have authority to issue rulings and orders regarding all procedural and evidentiary matters that the arbitrators deem reasonable and necessary with or without petition therefore by the Parties as well as the final ruling and judgment. All rulings by the arbitrators will be final. Notwithstanding any provision to the contrary set forth in this Agreement, any Party may seek equitable measures of protection in the form of attachment of assets or injunctive relief (including specific performance and injunctive relief) in any matter relating to the proprietary rights and interests of either Party from any court of competent jurisdiction, pending a decision by the arbitral tribunal in accordance with this Section 13.2 (Arbitration). The Parties hereby exclude any right of appeal to any court on the merits of such matter. The provisions of this Section 13.2 (Arbitration) may be enforced and judgment on the award (including equitable remedies) granted in any arbitration hereunder may be entered in any court having jurisdiction over the award or any of the Parties or any of their respective assets. Except to the extent necessary to confirm an award or as may be required by Laws, neither a Party nor an arbitrator may disclose the existence, content, or results of an arbitration without the prior written consent of both Parties. The Parties agree that, in the event of a dispute over the nature or quality of performance under this Agreement, neither Party may terminate this Agreement until final resolution of the dispute through arbitration or other judicial determination. Nothing in this Section 13.2 (Arbitration) will preclude either Party from seeking interim or provisional relief from a court of competent jurisdiction, including a temporary restraining order, preliminary injunction or other interim equitable relief, concerning a dispute either prior to or during any arbitration if necessary to protect the interests of such Party or to preserve the status quo pending the arbitration proceeding. Notwithstanding the Parties' agreement to arbitrate, unless the Parties agree in writing in any particular case, claims and disputes between the Parties relating to or arising out of, or for which resolution depends in whole or in part on a determination of the interpretation, scope, validity, enforceability or infringement of, Patent Rights or of any Trademark rights relating to any Licensed Products will not be subject to arbitration under this Agreement, and the Parties may pursue whatever rights and remedies may be available to them under law or equity, including litigation in a court of competent jurisdiction, with respect to such claims and disputes.", "": "" }, { "Text": "13.3 JURY WAIVER. EACH PARTY, TO THE EXTENT PERMITTED BY LAW, KNOWINGLY, VOLUNTARILY, AND INTENTIONALLY WAIVES ITS RIGHT TO A TRIAL BY JURY IN ANY ACTION OR OTHER LEGAL PROCEEDING ARISING OUT OF OR RELATING TO THIS AGREEMENT AND THE TRANSACTIONS IT CONTEMPLATES TO ARBITRATE AS SET FORTH IN SECTION 13.2 (ARBITRATION). THIS WAIVER APPLIES TO ANY ACTION OR LEGAL PROCEEDING, WHETHER SOUNDING IN CONTRACT, TORT OR OTHERWISE.", "": "" }, { "Text": "ARTICLE 14 MISCELLANEOUS", "": "" }, { "Text": "14.1 Assignment. This Agreement and the rights and obligations of each Party under this Agreement will not be assignable, delegable, transferable, pledged or otherwise disposed of by either Party without the prior written consent of the other Party; provided, however, that either Party may assign or transfer this Agreement together with all of its rights and obligations hereunder, without such consent (but with written notice to the other Party), (A) to an Affiliate or (B) to a successor in interest in connection with the transfer or sale of all or substantially all of its business or assets to which this Agreement relates, or in the event of its merger or consolidation, reorganization or similar transaction. Any permitted assignment of the rights and obligations of a Party under this Agreement will be binding on, and inure to the benefit of and be enforceable by and against, the successors and permitted assigns of the assigning Party. Any assignment in violation of this Section 14.1 (Assignment) will be null and void.", "": "" }, { "Text": "14.2 Choice of Laws. This Agreement will be governed by and interpreted under the Laws of the State of New York, without regard to the conflicts of law principles thereof. Any dispute, controversy, claim or difference of any kind whatsoever arising out of or in connection with this Agreement will be resolved exclusively in accordance with Section 13.2 (Arbitration); provided, however, that all questions concerning (a) inventorship of Patent Rights under this Agreement will be determined in accordance with Section 7.1 (Ownership of Inventions) and (b) the construction or effect of Patent Rights will be determined in accordance with the Laws of the country, Region or other jurisdiction in which the particular patent within such Patent Rights has been filed or granted, as the case may be. Any communication or proceedings resulting from disputes under this Agreement will be in English language. The Parties agree to exclude the application to this Agreement of the United Nations Conventions on Contracts for the International Sale of Goods (1980).", "": "" }, { "Text": "14.3 Notices. All notices that are required or permitted hereunder will be in writing and sufficient if delivered by internationally-recognized overnight courier or sent by registered or certified mail, postage prepaid, return receipt requested, and in each case, addressed as follows (with a courtesy copy sent by email, which will not constitute notice):", "": "" }, { "Text": "If to Landos: Landos Biopharma Inc 1800 Kraft Drive, Suite 216 Blacksburg, VA 24060 Attention: Dr. Josep Bassaganya-Riera Email: jbr@landosbiopharma.com", "": "" }, { "Text": "With copies to: Cooley LLP 55 Hudson Yards New York, New York 10001 Attention: Eric Blanchard Email: eblanchard@cooley.com", "": "" }, { "Text": "Cooley LLP 500 Boylston Street Boston, Massachusetts 02116 Attention: Geoffrey Spolyar Email: gspolyar@cooley.com", "": "" }, { "Text": "If to Lian: LianBio c/o Ogier Global (Cayman) Limited 89 Nexus Way Camana Bay Grand Cayman Cayman Islands KY1-9009 Attention: Brianne Jahn, Head of Operations and Finance, US Email: brianne.jahn@lianbio.com", "": "" }, { "Text": "With copies to: Ropes & Gray LLP 36F Park Place 1601 Nanjing Road West Shanghai, China 200040 Attention: Eric Wu and David R. Chen Fax: 86-21-6157-5299 Email: Eric.Wu@ropesgray.com  and David.Chen@ropesgray.com", "": "" }, { "Text": "or to such other address as the Party to whom notice is to be given may have furnished to the other Party in writing in accordance herewith. Any such notice will be deemed to have been given: (a) on the Business Day after dispatch if sent by internationally-recognized overnight courier; or (b) on the fifth Business Day after dispatch if sent by registered or certified mail, postage prepaid, return receipt requested.", "": "" }, { "Text": "14.4 Severability. In the event that one or more provisions of this Agreement is held invalid, illegal or unenforceable in any respect, then such provision will not render any other provision of this Agreement invalid or unenforceable, and all other provisions will remain in full force and effect and will be enforceable, unless the provisions that have been found to be invalid or unenforceable will substantially affect the remaining rights or obligations granted or undertaken by either Party. The Parties agree to attempt to substitute for any invalid or unenforceable provision a provision which achieves to the greatest extent possible the economic objectives of the invalid or unenforceable provision.", "": "" }, { "Text": "14.5 Integration. This Agreement, together with all schedules attached hereto, constitutes the entire agreement between the Parties with respect to the subject matter of this Agreement and supersedes all previous arrangements between the Parties with respect to the subject matter hereof, whether written or oral, including, effective as of the Effective Date, the Term Sheet (provided that all information disclosed or exchanged under such agreement will be treated as Confidential Information hereunder). In the event of a conflict between the Development Plan or any schedules or attachments to this Agreement, on the one hand, and this Agreement, on the other hand, the terms of this Agreement will govern. Each Party confirms that it is not relying on any representations or warranties of the other Party except as specifically set forth in this Agreement.", "": "" }, { "Text": "14.6 Waivers and Amendments. The failure of any Party to assert a right under this Agreement or to insist upon compliance with any term or condition of this Agreement will not constitute a waiver of that right or excuse a similar subsequent failure to perform any such term or condition by the other Party. The exercise by any Party of any right or election under the terms or covenants herein will not preclude or prejudice any Party from exercising the same or any other right it may have under this Agreement, irrespective of any previous action or proceeding taken by the Parties hereunder. Notwithstanding the authority granted to the JSC under this Agreement, (a) no waiver will be effective unless it has been given in writing and signed by the Party giving such waiver, and (b) no provision of this Agreement may be amended or modified other than by a written document signed by authorized representatives of each Party.", "": "" }, { "Text": "14.7 Independent Contractors; No Agency. Neither Party will have any responsibility for the hiring, firing or compensation of the other Party's or such other Party's Affiliates' employees or for any employee benefits with respect thereto. No employee or representative of a Party or its Affiliates will have any authority to bind or obligate the other Party for any sum or in any manner whatsoever, or to create or impose any contractual or other liability on such other Party, without such other Party's written approval. For all purposes, and notwithstanding any other provision to the contrary set forth in this Agreement, each Party's legal relationship under this Agreement to the other Party will be that of independent contractor, and the relationship between the two Parties will not constitute a partnership, joint venture, or agency, including for all tax purposes, except as otherwise required by applicable Law.", "": "" }, { "Text": "14.8 Affiliates, Sublicensees, and Contractors. To the extent that this Agreement imposes obligations on Affiliates, Sublicensees, or contractors of a Party, such Party will cause its Affiliates and its Sublicensees and contractors to perform such obligations, as applicable. Either Party may use one or more of its Affiliates, Sublicensees, or contractors to perform its obligations and duties or exercise its rights under this Agreement, solely to the extent permitted and as specified in this Agreement; provided that (a) each such Affiliate, Sublicensee, or contractor will perform any such obligations delegated to it in compliance with the applicable terms and conditions of this Agreement as if such Affiliate, Sublicensee, or contractor were a party hereto, (b) the performance of any obligations of a Party's by its Affiliates, Sublicensees, or contractors will not diminish, reduce, or eliminate any obligation of such Party under this Agreement, and (c) subject to such Party's assignment to an Affiliate pursuant to Section 14.1 (Assignment), such Party will remain liable under this Agreement for the prompt payment and performance of all of its obligations under this Agreement. Subject to this Section 14.8 (Affiliates, Sublicensees, and Contractors), if a Party exercises its rights and performs its obligations under this Agreement through one or more of its Affiliates, \"Landos\" will be interpreted to mean \"Landos or its Affiliates\" and \"Lian\" will be interpreted to mean \"Lian or its Affiliates\" where necessary to give each Party's Affiliates the benefit of the rights provided to such Party in this Agreement and the ability to perform its obligations under this Agreement.", "": "" }, { "Text": "14.9 Force Majeure. Neither Party will be held liable to the other Party nor be deemed to have defaulted under or breached this Agreement for failure or delay in achieving any objective, satisfying any condition, or performing any obligation under this Agreement to the extent that such failure or delay is caused by or results from acts or events beyond the reasonable control of such Party, including, without limitation, acts of God, embargoes, war, acts of war (whether war be declared or not), terrorism, insurrections, riots, civil commotions, strikes, lockouts, or other labor disturbances, government actions, unavailability of supplies, materials or transportation, fire, earthquakes, floods, epidemics, pandemics, the spread of infectious diseases, and quarantines (\"Force Majeure\"). The Parties agree the effects of the COVID-19 pandemic that is ongoing as of the Effective Date (including related government orders) may be invoked as a Force Majeure for the purposes of this Agreement even though the pandemic is ongoing and those effects may be reasonably foreseeable as of the Effective Date. In addition, a Force Majeure may include reasonable measures affirmatively taken by a Party or its Affiliates to respond to any epidemic, pandemic, or spread of infectious disease (including the COVID-19 pandemic), or other Force Majeure event, such as requiring employees to stay home, closures of facilities, delays of Clinical Trials, or cessation of activities in response to an epidemic or other Force Majeure event. Notwithstanding the foregoing, a Party will not be excused from making payments owed hereunder due to any such Force Majeure circumstances affecting such Party. The affected Party will notify the other Party in writing of any Force Majeure circumstances as soon as reasonably practical, and will provide a good faith estimate of the period for which its failure or delay in performance under the Agreement is expected to continue based on currently available information. The affected Party shall promptly undertake all reasonable efforts necessary to cure such Force Majeure circumstances.", "": "" }, { "Text": "14.10 No Third Party Beneficiary Rights. The representations, warranties, covenants and agreements set forth in this Agreement are for the sole benefit of the Parties and their successors and permitted assigns, and they will not be construed as conferring any rights on any other Third Party. This Agreement is not intended to and will not be construed to give any Third Party any interest or rights (including any Third Party beneficiary rights) with respect to or in connection with any agreement or provision contained herein or contemplated hereby, other than, to the extent provided in Article 10 (Indemnification; Damages), the Indemnified Parties.", "": "" }, { "Text": "14.11 Non-exclusive Remedy. Except as expressly provided herein, the rights and remedies provided herein are cumulative and each Party retains all remedies at law or in equity, including the Parties' ability to receive legal damages or equitable relief, with respect to any breach of this Agreement.", "": "" }, { "Text": "14.12 Interpretation. The Article and Section headings used herein are for reference and convenience only, and will not enter into the interpretation of this Agreement. Except as otherwise explicitly specified to the contrary, (a) references to an Article, Section or Schedule means an Article or Section of, or a Schedule to this Agreement and all subsections thereof, unless another agreement is specified; (b) references in any Section to any clause are references to such clause of such Section; (c) references to any agreement, instrument, or other document in this Agreement refer to such agreement, instrument, or other document as originally executed or, if subsequently amended, replaced, or supplemented from time to time, as so amended, replaced, or supplemented and in effect at the relevant time of reference thereto; (d) references to particular Laws mean such Laws as in effect as of the relevant time, including all rules and regulations thereunder and any successor Laws in effect as of the relevant time, and including the then-current amendments thereto; (e) words in the singular or plural form include the plural and singular form, respectively; (f) unless the context requires a different interpretation, the word \"or\" has the inclusive meaning that is typically associated with the phrase \"and/or\"; (g) the terms \"including,\" \"include(s),\" \"such as,\" \"e.g.\" and \"for example\" mean including the generality of any description preceding such term and will be deemed to be followed by \"without limitation\"; (h) whenever this Agreement refers to a number of days, such number will refer to calendar days unless Business Days are specified, and if a period of time is specified and dates from a given day or Business Day, or the day or Business Day of an act or event, it is to be calculated exclusive of that day or Business Day; (i) \"monthly\" means on a calendar month basis, (j) \"quarter\" or \"quarterly\" means on a Calendar Quarter basis; (k) \"annual\" or \"annually\" means on a Calendar Year basis; (l) \"year\" means a 365-day period unless Calendar Year is specified; (m) references to a particular Person include such Person's successors and assigns to the extent not prohibited by this Agreement; (n) the use of any gender herein will be deemed to encompass references to either or both genders, and the use of the singular will be deemed to include the plural (and vice versa); (o) a capitalized term not defined herein but reflecting a different part of speech than a capitalized term which is defined herein will be interpreted in a correlative manner; (p) any definition of or reference to any agreement, instrument or other document herein will be construed as referring to such agreement, instrument or other document as from time to time amended, supplemented or otherwise modified (subject to any restrictions on such amendments, supplements or modifications set forth herein); (q) the words \"hereof,\" \"herein,\" \"hereby\" and derivative or similar words refer to this Agreement (including any Schedules); (r) neither Party or its Affiliates will be deemed to be acting \"on behalf of\" the other Party under this Agreement, except to the extent expressly otherwise provided; (s) provisions that require that a Party, or the JSC hereunder \"agree\", \"consent\" or \"approve\" or the like will be deemed to require that such agreement, consent or approval be specific and in writing in a written agreement, letter or approved minutes, but, except as expressly provided herein, excluding e-mail and instant messaging; and (t) the word \"will\" will be construed to have the same meaning and effect as the word \"shall.", "": "" }, { "Text": "14.13 Further Assurances. Each Party will duly execute and deliver, or cause to be duly executed and delivered, such further instruments and do and cause to be done such further acts and things, including the filing of such assignments, agreements, documents, and instruments, as may be necessary or as the other Party may reasonably request in connection with this Agreement or to carry out more effectively the provisions and purposes hereof, or to better assure and confirm unto such other Party its rights and remedies under this Agreement (including working collaboratively to correct and clerical, typographical, or other similar errors in this Agreement).", "": "" }, { "Text": "14.14 Ambiguities; No Presumption. Each of the Parties acknowledges and agrees that this Agreement has been diligently reviewed by and negotiated by and between them, that in such negotiations each of them has been represented by competent counsel and that the final agreement contained herein, including the language whereby it has been expressed, represents the joint efforts of the Parties hereto and their counsel. Accordingly, in interpreting this Agreement or any provision hereof, no presumption will apply against any Party as being responsible for the wording or drafting of this Agreement or any such provision, and ambiguities, if any, in this Agreement will not be construed against any Party under the rule of construction, irrespective of which Party may be deemed to have authored the ambiguous provision.", "": "" }, { "Text": "14.15 Export Control. This Agreement is made subject to any restrictions required by applicable Laws concerning the export of products or technical information from the U.S. or other countries which may be imposed upon or related to the Parties from time to time. Each Party agrees that it will not export, directly or indirectly, any technology licensed to it or other technical information acquired from the other Party under this Agreement or any products using such technical information to a location or in a manner that at the time of export requires an export license or other governmental approval, except in compliance with U.S. export Laws and regulations.", "": "" }, { "Text": "14.16 Execution in Counterparts; Electronic Signatures. This Agreement may be executed in counterparts, each of which counterparts, when so executed and delivered, will be deemed to be an original, and all of which counterparts, taken together, will constitute one and the same instrument even if both Parties have not executed the same counterpart. Signatures provided by facsimile transmission or in Adobe™ Portable Document Format (PDF) sent by electronic mail will be deemed to be original signatures.", "": "" }, { "Text": "[Remainder of this page intentionally blank.]", "": "" }, { "Text": "IN WITNESS WHEREOF, each Party has caused this Agreement to be duly executed by its authorized representative under seal, in duplicate on the Effective Date.", "": "" }, { "Text": "LANDOS BIOPHARMA, INC.", "": "" }, { "Text": "__________________________________ Name: Title:", "": "" }, { "Text": "LIANBIO RESPIRATORY LIMITED", "": "" }, { "Text": "____________________________________ Name: Title:", "": "" }, { "Text": "SCHEDULE 1.29", "": "" }, { "Text": "LICENSED COMPOUNDS", "": "" }, { "Text": "BT-11 Piperazine-1,4-diylbis((6-(1H-benzo[d]imidazol-2-yl)pyridin-2-yl)methanone) (C30H24N8O2):", "": "" }, { "Text": "An exemplary BT-11 salt is piperazine-1,4-diylbis((6-(1H-benzo[d]imidazol-2-yl)pyridin-2-yl)methanone) dihydrochloride (C30H26Cl2N8O2):", "": "" }, { "Text": "NX-13 1,3,5-tris(6-methylpyridin-2-yloxy)benzene (C24H21N3O3):", "": "" }, { "Text": "SCHEDULE 1.76", "": "" }, { "Text": "LICENSED PATENTS", "": "" }, { "Text": "Patent Rights licensed by Landos", "": "" }, { "Text": "CN Patent 107108573, entitled \"Lanthionine Synthetase C-Like 2-Based Therapeutics,\" issued 16 June 2020, filed as CN Application 201580070262.8 on 22 June 2017.", "": "" }, { "Text": "HK Patent 1240921, entitled \"Lanthionine Synthetase C-Like 2-Based Therapeutics,\" issued 29 January 2021, filed as HK Application 18100276.5 on 9 January 2018, designated from CN Patent 107108573.", "": "" }, { "Text": "KR Patent 10-2026342, entitled \"Lanthionine Synthetase C-Like 2-Based Therapeutics,\" issued 23 September 2019, filed as KR Application 10-2017-7014045 on 24 May 2017.", "": "" }, { "Text": "KR Application 10-2020-7019853, entitled \"Lanthionine Synthetase C-Like 2-Based Therapeutics,\" filed 9 July 2020.", "": "" }, { "Text": "CN Application 201880083726.2, entitled \"Therapies with Lanthionine C-Like Protein 2 Ligands and Cells Prepared Therewith,\" filed 24 June 2020 from PCT/US18/61588.", "": "" }, { "Text": "HK Application 62020017841.1, entitled \"Therapies with Lanthionine C-Like Protein 2 Ligands and Cells Prepared Therewith,\" filed 14 October 2020 from EP 18816385.1.", "": "" }, { "Text": "KR Application 10-2020-7018225, entitled \"Therapies with Lanthionine C-Like Protein 2 Ligands and Cells Prepared Therewith,\" filed 24 June 2020 from PCT/US18/61588.", "": "" }, { "Text": "CN Application (not yet filed), intended to be filed via PCT from US Provisional Application 63/108,958, entitled \"Crystalline Forms of Piperazine-1,4-diylbis((6-(1H-benzo[d]imidazo-2-yl)pyridine-2-yl)methanone),\" filed 3 November, 2020.", "": "" }, { "Text": "HK Application (not yet filed), intended to be filed via PCT national phase from US Provisional Application 63/108,958, entitled \"Crystalline Forms of Piperazine-1,4-diylbis((6-(1H-benzo[d]imidazo-2-yl)pyridine-2-yl)methanone),\" filed 3 November, 2020.", "": "" }, { "Text": "KR Application (not yet filed), intended to be filed via PCT from US Provisional Application 63/108,958, entitled \"Crystalline Forms of Piperazine-1,4-diylbis((6-(1H-benzo[d]imidazo-2-yl)pyridine-2-yl)methanone),\" filed 3 November, 2020.", "": "" }, { "Text": "CN Application (not yet filed), intended to be filed via PCT from US Provisional Application 63/115,814, entitled \"Topical Administration of LANCL2 Agonists for Therapeutic Treatment of Surface Tissues,\" filed 19 November, 2020.", "": "" }, { "Text": "HK Application (not yet filed), intended to be filed via PCT national phase from US Provisional Application 63/115,814, entitled \"Topical Administration of LANCL2 Agonists for Therapeutic Treatment of Surface Tissues,\" filed 19 November, 2020.", "": "" }, { "Text": "KR Application (not yet filed), intended to be filed via PCT from US Provisional Application 63/115,814, entitled \"Topical Administration of LANCL2 Agonists for Therapeutic Treatment of Surface Tissues,\" filed 19 November, 2020.", "": "" }, { "Text": "CN Application 201980045394.3, entitled \"1,3,5-Tris(6-methylpyridin-2-yloxy)benzene Derivatives and Related Compounds as NLRX1 Ligands for Treating Inflammatory Diseases,\" filed 5 January 2021 from PCT/US19/040386.", "": "" }, { "Text": "HK Application (not yet filed), entitled \"1,3,5-Tris(6-methylpyridin-2-yloxy)benzene Derivatives and Related Compounds as NLRX1 Ligands for Treating Inflammatory Diseases,\" to be filed from EP 19745019.0.", "": "" }, { "Text": "KR Application 10-2021-7000175, entitled \"1,3,5-Tris(6-methylpyridin-2-yloxy)benzene Derivatives and Related Compounds as NLRX1 Ligands for Treating Inflammatory Diseases,\" filed 5 January 2021 from PCT/US19/040386.", "": "" }, { "Text": "SCHEDULE 2.8", "": "" }, { "Text": "KNOW-HOW TRANSFER", "": "" }, { "Text": "Landos to provide the files from the data room as indicated in the attached index thereto.", "": "" }, { "Text": "NOTICE OF EXERCISE", "": "" }, { "Text": "TO: The Secretary, DJS Antibodies Ltd (the \"Company\").", "": "" }, { "Text": "I, being the holder of the option granted in the Option Deed (as defined below) (the \"Option\"):", "": "" }, { "Text": "hereby exercise the Option to acquire [ ] [B] ordinary shares of £0.01 each in the capital of the Company (the \"Shares\") at a price of [ ] per Share (the \"Aggregate Exercise Price\"), subject to the provisions contained in the Option Deed dated [ ] (the \"Option Deed\") made pursuant to the DJS Antibodies Ltd EMI Share Option Scheme (the \"Plan\"), such exercise to take effect immediately prior to completion of the sale of the entire issued share capital of the Company to Pioneer Subsidiary LLC (the \"Purchaser\") (the \"Sale\");", "": "" }, { "Text": "authorise and request you to enter my name in the Company's register of members as the holder of the Shares, subject to the Company's memorandum and articles of association;", "": "" }, { "Text": "understand and accept that I am entitled to exercise my Option(s) by reason of the Sale, and that the exercise of my Option(s) shall take effect immediately prior to the Sale completing and if, for any reason, the Sale does not complete, I understand and accept that my Option(s) will continue to exist in accordance with the original terms;", "": "" }, { "Text": "understand that I will be entitled to borrow from the Company an amount equal to the Aggregate Exercise Price pursuant to the terms of a loan agreement to be entered into between me and the Company on or about the date of this agreement (the \"Loan Agreement\") and, if I enter into the Loan Agreement, hereby direct the Company to retain such monies in discharge of my obligation to pay the Aggregate Exercise Price;", "": "" }, { "Text": "hereby request that the Company irrevocably and unconditionally directs the Purchaser (on my behalf) to deduct an amount equal to the monies lent under the Loan Agreement (if any) and pay such amount to the Company on my behalf in satisfaction of my obligation to repay the loan pursuant to the terms of the Loan Agreement (in order to satisfy the payment of the Aggregate Exercise Price) to the extent that I have not already paid such amount to the Company;", "": "" }, { "Text": "hereby request that the Company will deduct from the consideration payable to me under the Sale an amount that the Company reasonably considers satisfies any income tax and social security contributions or their equivalent in any jurisdiction (including both employee and (to the extent lawful) employer National Insurance contributions, or equivalent)) due on or arising in connection with the exercise of my Option(s) for which the Company or the Purchaser are responsible and liable for paying to the relevant tax authorities;", "": "" }, { "Text": "hereby covenant to pay the Company the amount of any Tax Liability which may arise as a consequence of or in connection with this exercise of the Option(s) in accordance with Rules 14 and 15 of the Plan and which shall continue to have effect for the purposes of this Notice of Exercise notwithstanding that the Plan may be terminated (and, for the purposes of this Notice of Exercise, the expression \"Tax Liability\" has the same meaning as it has in the Plan);", "": "" }, { "Text": "hereby confirm that, subject to the exercise of my Option(s) in accordance with this Notice of Exercise, I have no right, title or interest in the Option Deed and I shall not bring, commence, continue or prosecute any claim, legal action or proceeding under, in relation to, arising out of or in connection with the Option Deed against the Company, any of its affiliates and any successor entities thereto.", "": "" }, { "Text": "in order to give effect to this covenant, I hereby authorise and appoint the Company as my attorney in my name and on my behalf:", "": "" }, { "Text": "to sell such number (but no more) of the Shares registered in my name as will enable the Company (after payment of all necessary selling expenses and commissions) to recover and retain for itself from the sale proceeds an amount equal to such Tax Liability and then account to me for any cash balance remaining, provided that the Company may sell that number of shares at such price or prices as it shall, in its absolute discretion, consider fair and reasonable, and", "": "" }, { "Text": "generally to sign any stock transfer form or other document or documents which may be required and to do any other thing which the Company shall consider necessary or expedient for carrying out the acts hereby authorised in the same manner and as fully in all respects as I could have done personally and I hereby undertake to ratify everything which the Company shall do or purport to do by virtue of this power of attorney; and", "": "" }, { "Text": "request you to send a share certificate in respect of the Shares not sold pursuant to the authority given above (and, if appropriate, a balance option certificate) to me at the address given below.", "": "" }, { "Text": "[footnote: Note to Goodwin: is this clause necessary since 1.6 deals with the same point. Goodwin note: Whilst it looks similar to 1.6, we do not consider that the provisions cover the same matter.]", "": "" }, { "Text": "SIGNED AND DELIVERED as a DEED by DAVID LLEWELLYN acting under a power of attorney for and on behalf of [●] in the presence of:", "": "" }, { "Text": "……………………………………………………….", "": "" }, { "Text": "Witness: Signature: Name: Address: Occupation:", "": "" }, { "Text": "………………………………………………………………. ………………………………………………………………. ………………………………………………………………. ……………………………………………………………….", "": "" }, { "Text": "Date:…………………………………………….", "": "" }, { "Text": "EXECUTION VERSION
CONTINGENT VALUE RIGHTS AGREEMENT
DATED OCTOBER 4, 2023
BY AND BETWEEN
MITOKININ, INC.,
SHAREHOLDER REPRESENTATIVE SERVICES LLC, solely in its capacity as the representative, agent and attorney-in-fact of the Indemnifying Stockholders
AND
SAPPHIRE MERGER SUB, INC. solely with respect to Section 4.2, Section 4.3 and Section 5", "": "" }, { "Text": "TABLE OF CONTENTS
Page
-i-
SECTION 1 DEFINITIONS.........................................................................................................................1
1.1 Definitions ..........................................................................................................................1
SECTION 2 CONTINGENT VALUE RIGHTS..........................................................................................7
2.1 CVRs ..................................................................................................................................7
2.2 Register...............................................................................................................................7
2.3 Transfer Taxes; Tax Documentation ..................................................................................9
2.4 Contingent Payments After Special Redemption. ..............................................................9
2.5 Ability To Abandon The CVR .........................................................................................14
SECTION 3 [Intentionally omitted] ...........................................................................................................14
SECTION 4 COVENANTS .......................................................................................................................14
4.1 Review and Audit of Net Sales Future Payments.............................................................14
4.2 Obligations Upon Sale of the Company ...........................................................................15
4.3 Post-Warrant Exercise Closing Development ..................................................................15
4.4 AbbVie Obligations..........................................................................................................16
SECTION 5 MISCELLANEOUS PROVISIONS......................................................................................17
5.1 Entire Agreement; Amendments and Waivers .................................................................17
5.2 Notices ..............................................................................................................................17
5.3 Assignment .......................................................................................................................18
5.4 Specific Enforcement .......................................................................................................18
5.5 Third-Party Beneficiaries .................................................................................................18
5.6 Governing Law; Specific Performance; Dispute Resolution; Waiver of Jury Trial.........18
5.7 Severability.......................................................................................................................19
5.8 Counterparts......................................................................................................................19
5.9 Termination ......................................................................................................................19
5.10 Interpretation ....................................................................................................................20", "": "" }, { "Text": "CONTINGENT VALUE RIGHTS AGREEMENT

THIS CONTINGENT VALUE RIGHTS AGREEMENT, dated as of October 4, 2023 (this \"Agreement\"), is entered into by and among Mitokinin, Inc., a Delaware corporation (the \"Company\"), Shareholder Representative Services LLC, a Colorado limited liability company, solely in its capacity as the representative, agent and attorney-in-fact of the Indemnifying Stockholders (the \"Equityholders' Representative\"), and, solely with respect to Section 4.2, Section 4.3, and Section 5, Sapphire Merger Sub, Inc. a Delaware corporation (\"AbbVie\").

RECITALS

WHEREAS, the Company issued to AbbVie, in exchange for an aggregate cash payment of $26 million, one Class H Share and a warrant to acquire one hundred shares of Class H Common Stock of the Company (the \"Warrant Shares\") pursuant to that certain Agreement to Purchase Class H Common Stock and Warrant to Purchase Class H Common Stock of the Company, dated February 25, 2021 (as amended at any time prior to the Warrant Exercise Closing, the \"Warrant\").

WHEREAS, on February 25, 2021 the requisite stockholders of the Company approved that certain Third Amended and Restated Certificate of Incorporation of the Company (as amended at any time prior to the Warrant Exercise Closing, the \"Certificate of Incorporation\") pursuant to Part C of Article FOURTH of which, inter alia, upon AbbVie exercising the warrant to purchase the Warrant Shares (the \"Warrant Exercise\"), the Company is required to automatically and mandatorily redeem all Company Capital Stock (other than Warrant Shares) that are outstanding immediately prior to the Special Redemption Time (as defined in the Certificate of Incorporation), in exchange for the Initial Redemption Payment and the CVRs created by this Agreement (the \"Special Redemption\").

WHEREAS, it is a condition to the Warrant Exercise Closing for the parties hereto to execute and deliver this Agreement to the other parties hereto.

WHEREAS, pursuant to the Certificate of Incorporation, the CVRs are to be allocated to the Indemnifying Stockholders in connection with the Special Redemption.

AGREEMENT

The parties to this Agreement, for and in consideration of the premises and the consummation of the transactions referred to above, intending to be legally bound, hereby mutually covenant and agree, for the equal and proportionate benefit of all Indemnifying Stockholders, as follows:", "": "" }, { "Text": "SECTION 1 DEFINITIONS

1.1 Definitions. Capitalized terms used but not otherwise defined herein shall have the meanings ascribed thereto in the Warrant. The following terms shall have the meanings ascribed to them below:", "": "" }, { "Text": "Accounting Standards\" means, with respect to a Party, that such Party shall maintain records and books of accounts in accordance with (a) Generally Accepted Accounting Principles as applied in the country of such Person's jurisdiction or (b) to the extent applicable, International Financial Reporting Standards as issued by the International Accounting Standards Board, in each case, consistently applied.", "": "" }, { "Text": "Contingent Milestone\" means each of (a) the Development Milestones, (b) the Commercialization Milestones and (c) the Net Sales Threshold Milestones.", "": "" }, { "Text": "Contingent Milestone Payment\" means any payment that becomes due in accordance with the terms hereof as a result of the achievement of a Contingent Milestone.", "": "" }, { "Text": "Contingent Payment\" means (a) each of the Contingent Milestone Payments that becomes due in accordance with the terms hereof and (b) each of the Net Sales Annual Payments that becomes due in accordance with the terms hereof.", "": "" }, { "Text": "Contingent Payment Notice\" means any of a Contingent Milestone Payment Notice or a Net Sales Payment Notice.", "": "" }, { "Text": "CVR\" means the right of an Indemnifying Stockholder to receive a portion of the Contingent Payments, if any.", "": "" }, { "Text": "Development Milestone\" means either of (a) the Phase II Development Milestone or (b) the Phase III Development Milestone.", "": "" }, { "Text": "Dispute Settlement Licensee\" means any Licensee that is granted a license in order to settle a litigation or dispute related to any Company Patents in connection with a Company Product or a Generic Product, including any such litigation or dispute with any third party that has submitted an application to a Governmental Authority to market a Generic Product; provided, however, that any cash consideration received by AbbVie from a Dispute Settlement Licensee solely after AbbVie has recovered all costs incurred by AbbVie or its Affiliates in connection with the applicable dispute settlement from such Licensee, will be deemed to be Net Sales of AbbVie solely for the purpose of calculating AbbVie's Net Sales Annual Payment under Section 2.1(b)", "": "" }, { "Text": "EU\" means the European Union.", "": "" }, { "Text": "European Commercialization Milestone\" means the earliest First Commercial Sale in any European Major Market.", "": "" }, { "Text": "European Major Market\" means each of (a) France, (b) Germany, (c) Spain, (d) Italy or (e) the United Kingdom.", "": "" }, { "Text": "First Commercial Sale\" means, with respect to a PINK1 Product and a country, the first sale for monetary value for use or consumption by the end user of such PINK1 Product in such country after all Regulatory Approvals for such PINK1 Product have been obtained in such country. Sales prior to receipt of all Regulatory Approvals for such PINK1 Product, such as so-called \"treatment IND sales,\" \"named patient sales,\" and \"compassionate use sales,\" shall not be construed as a First Commercial Sale.", "": "" }, { "Text": "Generic Product\" means, with respect to a PINK1 Product, any product that (a) contains a PINK1 Activator as an active ingredient and (b) (I) is the subject of a Regulatory Approval for use in such country and may be substituted for such PINK1 Product without the intervention of the prescribing HCP or (II) is approved in reliance, in whole or in part, on the prior approval (or on safety or efficacy data submitted in support of the prior approval) of such PINK1 Product as determined by the applicable Governmental Authority, including any product authorized for sale (i) in the U.S. pursuant to Section 505(b)(2) or Section 505(j) of the FDCA (21 U.S.C. 355(b)(2) and 21 U.S.C. 355(j), respectively), (ii) in the EU pursuant to a provision of Articles 10, 10a or 10b of Parliament and Council Directive 2001/83/EC as amended (including an application under Article 6.1 of Parliament and Council Regulation (EC) No 726/2004 that relies for its content on any such provision), or (iii) in any other country or jurisdiction, including in the United Kingdom after the end of the transition period as such period is defined at Art. 126 of the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community, pursuant to all equivalents of such provisions, including any amendments and successor statutes with respect to the subsections (i) through (iii) thereto. A product licensed or produced by AbbVie or any of its Affiliates under the same Drug Approval Application as a PINK1 Product (i.e., an authorized generic product) will not constitute a Generic Product with respect to that PINK1 Product.", "": "" }, { "Text": "Japan Commercialization Milestone\" means the First Commercial Sale in Japan.", "": "" }, { "Text": "Joinder Agreement\" has the meaning set forth in the Equityholder Representation and Indemnity Agreement.", "": "" }, { "Text": "Letter of Transmittal\" has the meaning set forth in the Equityholder Representation and Indemnity Agreement.", "": "" }, { "Text": "Net Sales\" means, with respect to a PINK1 Product for any period, the total amount billed or invoiced on sales of such PINK1 Product during such period by the Company, its Affiliates, or Licensees (other than Dispute Settlement Licensees) to third parties (including wholesalers or Distributors), in bona fide arm's length transactions, less the following deductions, in each case related specifically to such PINK1 Product and actually allowed and taken by such third parties and not otherwise recovered by or reimbursed to the Company, its Affiliates, or Licensees:

(a) trade, cash and quantity discounts;

(b) price reductions or rebates, retroactive or otherwise, imposed by, negotiated with or otherwise paid to governmental authorities or other payees;

(c) taxes on sales (such as sales, value added, or use taxes) to the extent added to the sale price and set forth separately as such in the total amount invoiced;

(d) amounts repaid or credited by reason of rejections, defects, return goods allowance, recalls or returns, or because of retroactive price reductions, including rebates or wholesaler charge backs;

(e) the portion of administrative fees paid during the relevant time period to group purchasing organizations, pharmaceutical benefit managers or Medicare Prescription Drug Plans relating to such PINK1 Product;

(f) any invoiced amounts from a prior period which are not collected and are written off by the Company or its Affiliates, including bad debts;

(g) that portion of the annual fee on prescription drug manufacturers imposed by the PPACA and reasonably allocable to sales of the PINK1 Products;

(h) freight, insurance, import/export, and other transportation charges to the extent added to the sale price and set forth separately as such in the total amount invoiced, as well as any fees for services provided by wholesalers and warehousing chains related to the distribution of such PINK1 Product; and

(i) any other similar and customary deductions that are consistent with Accounting Standards, but which may not be duplicative of the deductions specified in (a) – (h) above.", "": "" }, { "Text": "ACTIVE/115553369.1 Privileged and Confidential AMENDMENT AGREEMENT dated February 25, 2022 to the LICENSE AGREEMENT dated December 18, 2017 (as amended on March 8, 2021) by and among: SYNDESI THERAPEUTICS SA and UCB BIOPHARMA SRL", "": "" }, { "Text": "This AMENDMENT AGREEMENT (the \"Amendment Agreement\") is made on February 25, 2022 BETWEEN:", "": "" }, { "Text": "(1) SYNDESI THERAPEUTICS SA, a Belgian limited liability company (\"société anonyme\") having its registered office at Chemin du Cyclotron 6, 1348 Ottignies-Louvain-la-Neuve, Belgium, and registered with the Crossroads Bank for Enterprises under number 0686.599.355 (the \"Company\"); and", "": "" }, { "Text": "(2) UCB BIOPHARMA SRL, a Belgian limited liability company (\"société à responsabilité limitée\") having its registered office at Allée de la Recherche 60, 1070 Anderlecht, Belgium, and registered with the Crossroads Bank for Enterprises under number 0543.573.053 (\"UCB\").", "": "" }, { "Text": "The Company and UCB are together referred to as the \"Parties\" and may each be referred to as a \"Party\".", "": "" }, { "Text": "WHEREAS:", "": "" }, { "Text": "(A) UCB and the Company have entered into a license agreement on December 18, 2017 which has been amended through an addendum dated March 8, 2021 (the license agreement as amended, the \"License Agreement\") relating to the grant by UCB to the Company of an exclusive worldwide license under the UCB Licensed IP (as defined in the License Agreement) for the research, development and commercialization of the UCB Licensed Compounds and the Licensed Products (each as defined in the License Agreement).", "": "" }, { "Text": "(B) On or about the date hereof, UCB and the other shareholders of the Company have entered into an agreement with AbbVie Central Finance B.V., a Dutch private limited liability company (\"besloten vennootschap\") (\"AbbVie\") for the sale and purchase of all shares in the Company (the \"SPA\"). One of the actions to be performed by UCB prior to Completion (as defined in the SPA) is the delivery to AbbVie of a duly executed copy of this Amendment Agreement.", "": "" }, { "Text": "(C) In this context, the Parties wish to (i) make certain amendments to the License Agreement, (ii) replace the labelling of the defined terms \"SV2A Negative Modulator\" and \"SV2A Positive Modulator\" by \"Syndesi SV2A Modulator\" and \"UCB SV2A Modulator\" respectively, for semantic purpose (and for clarity, without modifying, save for the clarification set out in Clause 2.8, last sentence below, the definition of said defined terms nor the scope of the license rights granted under the License Agreement) and (iii) confirm certain undertakings vis-à-vis each other in connection to the License Agreement, in accordance with the terms and conditions set forth in this Amendment Agreement, it being understood that the License Agreement shall remain in full force and effect, save to the extent amended by this Amended Agreement.", "": "" }, { "Text": "THE PARTIES HAVE AGREED AS FOLLOWS:", "": "" }, { "Text": "1. DEFINITIONS Capitalized terms and expressions used, but not otherwise defined, herein will have the meaning ascribed to them in the License Agreement, unless explicitly provided otherwise.", "": "" }, { "Text": "2. AMENDMENTS TO THE LICENSE AGREEMENT", "": "" }, { "Text": "The following amendments are made to the License Agreement with immediate effect:", "": "" }, { "Text": "Definitions", "": "" }, { "Text": "2.1. A new definition of \"AbbVie\" is added, reading as follows: \"means AbbVie Central Finance B.V., a private limited liability company (\"besloten vennootschap\") organized and existing under the laws of the Netherlands with company number 69571627 and whose registered office is at 53 Zuiderlaan, 8017JV Zwolle, the Netherlands;", "": "" }, { "Text": "2.2. The definition of \"Commercially Reasonable Efforts\" is replaced as follows: \"means, with respect to activities which are subject to a Commercially Reasonable Efforts obligation pursuant to this Agreement, the carrying out of such activities using efforts and resources comparable to the efforts and resources that a company in the pharmaceutical industry with similar resources as the Company would reasonably be expected to devote to products of similar market potential at a similar stage in development or product life, taking into account any all scientific, commercial or other factors that such company would typically take into account, including issues of patent coverage, safety and efficacy, expected and actual cost and time to develop, the nature and extent of expected and actual market exclusivity (including patent coverage and regulatory exclusivity), expected and actual competitiveness of alternative third party products (including generic) in the marketplace, the proprietary position of the Licensed Product, the expected likelihood of regulatory approval, the expected and actual reimbursability and pricing, and the expected and actual amounts of marketing and promotional expenditures required and the profitability of the applicable Licensed Product.", "": "" }, { "Text": "2.3. A new definition of \"Development Activities\" is added, reading as follows: \"means any actions with respect to the research and development of the UCB Licensed Compounds and the Licensed Products, including clinical trials, chemistry, manufacturing, and controls (CMC), as well as the actions with respect to applying for, pursuing, accepting, obtaining or maintaining any Marketing Authorizations, permits, approvals, or other regulatory entitlements from any governmental or other regulatory entities in respect thereof; and CMC compound and product updates will include development status of formulation, manufacturing process, analytical methodology and controls, stability and GMP batches;", "": "" }, { "Text": "2.4. The definition of \"Development Plan\" is deleted in its entirety and all references throughout the License Agreement to \"Development Plan\" are to be understood as references to \"Development Activities\".", "": "" }, { "Text": "2.5. A new definition of \"Encumbrance\" is added, reading as follows: \"any Third Party interest or equity (and, for avoidance of doubt, the licenses granted to the Company in Clause 2.1 of this Agreement are not in themselves a Third Party interest or equity), such as an option, right to acquire, right of pre-emption, mortgage, charge, pledge, lien, security interest, hypothecation, title retention or other form of security or encumbrance that creates any of the foregoing, excluding (i) any rights or obligations under the Walloon Region Agreements (for as long as and to the extent those remain in effect) and (ii) a non-exclusive license granted to F. Hoffmann - La Roche Ltd under the Roche MTA to use the MTA Results solely for F. Hoffmann - La Roche Ltd's internal research and development purposes (and not including any rights to market, sell or otherwise commercially exploit any products or services which incorporate the MTA Results). \"Encumber\" shall have a correlative meaning;", "": "" }, { "Text": "2.6. The definition of \"Licensed Product\" is replaced as follows: \"means any pharmaceutical or diagnostic product containing (i) a UCB Licensed Compound or (ii) any other compound (including any racemates, salts, metabolites, esters, diastereomers, tautomers, enantiomers, prodrug forms, hydrates, solvates, intermediates, polymorphs and degradants thereof, that have substantially the same pharmacological effect, in crystal, powder or other form) which is covered by a UCB Licensed Patent, in each case ((i) and (ii)) excluding any UCB SV2A Modulators;", "": "" }, { "Text": "2.7. A new definition of \"SPA\" is added, reading as follows: \"means the agreement for the Sale and Purchase of Syndesi Therapeutics SA, dated February 25, 2022, by and among the Persons listed in Schedule One of the SPA as Sellers, AbbVie as Buyer and Shareholder Representative Services LLC, as Sellers' Representative;", "": "" }, { "Text": "2.8. A new definition of \"Syndesi SV2A Modulator\" is added, reading as follows: \"means small molecule compounds that: (i) are within the Chemical Space; (ii) show a binding affinity to SV2A of pIC50 > 6; (iii) demonstrate in the audiogenic seizure model in mice a protective effect ≤ 30 % against clonic convulsions at 320 µMol/kg (administered i.p., 30 min before testing in the audiogenic chamber; the experimental procedure for which is described in the UCB Pharma SA – Scientific and Technical Report – January – December 2010, which is listed in Part C of Schedule 2); and (iv) demonstrate antagonistic activity to levetiracetam in the audiogenic seizure model in mice, achieving at least a displacement factor of 2 (where the displacement factor is defined as the ratio of levetiracetam's ED50 values in a combination study in the presence versus the absence of 320 µmol/kg of the SV2A compound. The ED50 value is calculated as the dose of levetiracetam inducing 50% protection against clonic convulsions relative to the control group in in the mouse audiogenic seizure model (the experimental procedure for which is described in the UCB Pharma SA – Scientific and Technical Report – January-December 2010, which is listed in Part C of Schedule 2)).", "": "" }, { "Text": "For clarity, (4R)-1-[(5-chloro-1H-1,2,4-triazol-1-yl)methyl)]-4-(3,4,5-trifluoro-phenyl) pyrrolidin-2-one), also known by UCB code UCB0255, and any racemates, salts, metabolites, esters, diastereomers, tautomers, enantiomers, prodrug forms, hydrates, solvates, intermediates, polymorphs and degradants thereof, in each case, that have substantially the same pharmacological effect, in crystal, powder or other form falls within this definition of Syndesi SV2A Modulator;", "": "" }, { "Text": "2.9. A new definition of \"UCB SV2A Modulator\" is added, reading as follows: \"means small molecule compounds that (i) are within the Chemical Space; (ii) show a binding affinity to SV2A of pIC50 > 6; and (iii) are not an Syndesi SV2A Modulator;", "": "" }, { "Text": "2.10. The definition of \"SV2A Negative Modulator\" is deleted in its entirety and all references throughout the License Agreement to \"SV2A Negative Modulator\" are to be understood as references to \"Syndesi SV2A Modulator\" as defined in Clause 2.8 of this Amendment Agreement.", "": "" }, { "Text": "2.11. The definition of \"SV2A Positive Modulator\" is deleted in its entirety and all references throughout the License Agreement to \"SV2A Positive Modulator\" are to be understood as references to \"UCB SV2A Modulator\" as defined in Clause 2.9 of this Amendment Agreement.", "": "" }, { "Text": "2.12. For clarity, although references to \"SV2A Negative Modulator\" are to be understood as references to \"Syndesi SV2A Modulator\" and all references to \"SV2A Positive Modulator\" are to be understood as references to \"UCB SV2A Modulator\", UCB shall not be expected to formally amend the terminology of any documents or references included in Schedule 1 (Follow-On Compounds) and/or Schedule 2 - Part C (UCB Compound Know-How) which refer to \"SV2A Negative Modulator\" or \"SV2A Positive Modulator\". The new terminology provided under this Amendment does not amend the scope of Follow-On Compounds or UCB Compound Know-How which was originally defined in said schedules.", "": "" }, { "Text": "License", "": "" }, { "Text": "2.13. At the end of Clause 2.1 (License Grant), a new paragraph is added reading as follows: \"All rights and licenses granted to the Company under this Agreement shall also automatically be for the benefit of any of the Company's Affiliates (from time to time) if and to the extent any such Affiliate is sub-licensed (including through multiple tiers) such rights and licenses, save that the second sentence of Clause 2.2.1 and the last two sentences of Clause 2.2.2 shall not apply to the Company's Affiliates (from time to time), provided that the Company shall at all times remain fully responsible for the obligations under this Agreement. For the avoidance of doubt, if an entity ceases to be an Affiliate of the Company, it shall also automatically cease to benefit from the rights and licenses granted to the Company under this Agreement.", "": "" }, { "Text": "2.14. In Clause 2.5.2 (Non-compete), the words \"its sub-licensees\" are replaced by \"its licensees\".", "": "" }, { "Text": "Diligence and Reporting", "": "" }, { "Text": "2.15. Clause 3.1 (Diligence) is replaced as follows: \"The Company shall use Commercially Reasonable Efforts to develop, obtain Marketing Authorization for, and Exploit one Licensed Product in the United States and three of the Major European Markets. UCB acknowledges and agrees that the Company shall have the right to satisfy its diligence obligations under this Clause 3.1 through its Affiliates or Sub-licensees.", "": "" }, { "Text": "2.16. In Clause 3.2.2, the words \"six (6) month period\" are each time replaced by the words \"twelve (12) month period\" and the words \"six (6) months\" are replaced by the words \"twelve (12) months\".", "": "" }, { "Text": "2.17. Clause 3.2.3 is replaced as follows: \"Notwithstanding anything to the contrary in this Agreement and without prejudice to Clause 3.1 (Diligence), Company shall notify UCB in writing promptly in case the development and/or Exploitation of the Licensed Product is suspended for a period exceeding eleven (11) consecutive months with indication of the reason(s) of such suspension.", "": "" }, { "Text": "2.18. In Clause 3.2.4, the word \"twice\" is replaced by the word \"once\".", "": "" }, { "Text": "Payment Terms", "": "" }, { "Text": "2.19. Clause 5.3 is replaced as follows: \"If Products are sold or supplied by the Company, its Sub-licensees or its or their Affiliates in a currency other than Euros, the Royalties payable in respect of such sales under this Agreement shall be first determined in the currency of the country in which such sales took place and then converted into Euros at the average exchange rate (between the currency other than Euros and Euros) over the Quarter in which the relevant sales took place as made available on Bloomberg, (or an equivalent resource generally accepted in the pharma industry allowing independent verification of the relevant average exchange rates).", "": "" }, { "Text": "Records and Inspections", "": "" }, { "Text": "2.20. At the end of Clause 6.3.1, the following sentence is added: \"provided that the independent professional accountant that may be appointed by UCB shall disclose to UCB only its opinion on the amount of Royalties or other sums due to UCB under this Agreement (including the amount of any inaccuracy of any statement provided by the Company in relation to Royalties and/or sales (if any)), and no other information shall be shared with UCB (including, without limitation, the books and records that have been accessed).", "": "" }, { "Text": "Covenants", "": "" }, { "Text": "2.21. A new Clause 9 (Covenants) is added, causing the existing Clauses 9 (Limitation of Liability and Indemnity) to 17 (General) to be renumbered accordingly (and causing all references to such renumbered clauses to be updated accordingly).", "": "" }, { "Text": "2.22. A new Clause 9.1 is added, reading as follows: \"UCB shall not assign or otherwise transfer the UCB Licensed IP to a Third Party, unless the Third Party assignee (i) expressly covenants to be bound and abide by the terms of this Agreement, and receive the assignment of the UCB Licensed IP subject to the licenses granted under the terms of this Agreement and (ii) expressly identifies the Company as a Third Party beneficiary with the right to enforce directly against such Third Party assignee the covenant in this Clause 9.1 and the terms of this Agreement. UCB may not individually assign certain of the UCB Licensed Patents or UCB Licensed IP and shall only be allowed to assign the UCB Licensed IP collectively to a single assignee (or assignees who are Affiliates within the same group of Affiliates acting together in the course of a single transaction), to which this Agreement is then also assigned in accordance with Clause 18.4 (Assignment), unless an individual assignment of certain UCB Licensed Patents or UCB Licensed IP is made with Company prior written consent which shall not be unreasonably withheld, delayed or conditioned.", "": "" }, { "Text": "2.23. A new Clause 9.2 is added, reading as follows: \"UCB shall not otherwise Encumber the UCB Licensed IP or grant any license or any other rights to any Third Party that conflict with the rights granted to the Company under this Agreement.", "": "" }, { "Text": "2.24. A new Clause 9.3 is added, reading as follows: \"The Parties mutually agree that the Company shall have the exclusive right to opt-in or opt-out of the EU Unitary Patent System for all UCB Licensed IP. UCB shall (a) provide to the Company all information, including a correct and complete list of UCB Licensed IP covering any UCB Licensed Compounds, compounds falling within the Chemical Space or Licensed Product or otherwise necessary or reasonably useful to enable the Company to evaluate, make decisions and take action regarding whether to opt-in or opt-out of the EU Unitary Patent System, and (b) cooperate with the Company's reasonable requests in connection therewith, including meeting any submission deadlines, in each case ((a) and (b)), to the extent required or permitted by Applicable Law. In the event that any submission necessary to affect the Company's decision to opt-in or opt-out of the EU Unitary Patent System requires UCB's consent, the filing or submission of any documents by UCB, the execution of any documents by UCB, or otherwise requires UCB's cooperation, UCB shall consent and cooperate, including making any necessary submissions under the Company's direction.", "": "" }, { "Text": "2.25. A new Clause 9.4 is added, reading as follows: \"UCB shall use best efforts to, and if necessary to cause \"UCB Pharma, S.A.\" to, file (or have filed) a corrective patent assignment (in the form agreed as Exhibit A to this Amendment Agreement) and any other appropriate official document (as reasonably determined by UCB's patent attorneys) as necessary to remediate the clerical error in the name of \"UCB Pharma S.A.\" (without the foregoing comma) such that all rights in US patent 9,630,948 are duly recorded in the name of UCB Biopharma SRL without any defect (if any) in the chain of title, as soon as practically possible after the effective date of this Amendment Agreement\".", "": "" }, { "Text": "Intellectual Property Ownership, License and Publications", "": "" }, { "Text": "2.26. A new Clause 11.4.3 is added, reading as follows: \"to any UCB SV2A Modulators that either (i) the Company or its Affiliates may obtain through an acquisition of an entity that has identified, developed, discovered or conceived such UCB SV2A Modulators independently prior to the acquisition of such entity by the Company or one of its Affiliates or (ii) an Acquirer has identified, developed, discovered or conceived at any time independently without use of the UCB Licensed IP.", "": "" }, { "Text": "Patent Prosecution and Maintenance", "": "" }, { "Text": "2.27. Clause 12.1.1(c) (former) / Clause 13.1.1(c) (new) is replaced as follows: \"provide UCB with copies of all substantive correspondence to or from a patent office with respect to the Selection Patent Rights that are to be filed with patent authorities in the Territory, at least thirty (30) days in advance of the Company's anticipated filing date or any relevant deadline therefor.", "": "" }, { "Text": "2.28. Clause 12.1.1(e) (former) / Clause 13.1.1(e) (new) is deleted in its entirety.", "": "" }, { "Text": "Revocation Proceedings", "": "" }, { "Text": "2.29. At the end of Clause 13.1.4 (former) / Clause 14.1.4 (new), the following sentence is added: \"for clarity, no such information or consultation shall be necessary and no such comments shall need to be incorporated to the extent the proceedings concern Company Arising Patent Rights or other Patent Rights covering inventions independently created by the Company or the Company's Affiliates after the Effective Date (including where Selection Patent Rights or Pyrrolidine Patent Rights are also implicated in the proceedings, provided in such case however that the settlement negotiations only concern, or that a settlement is only entered into with respect to, the Company Arising Patent Rights or the Patent Rights covering inventions independently created by the Company or the Company's Affiliates after the Effective Date).", "": "" }, { "Text": "Infringement of the UCB Licensed IP", "": "" }, { "Text": "2.30. At the end of Clause 14.3.3 (former) / Clause 15.3.3 (new), the following sentence is added: \"for clarity, no such collaboration or consultation shall be necessary and no such advice or comments shall need to be taken into account and no such approval shall be required to the extent the proceedings concern Company Arising Patent Rights or other Patent Rights covering inventions independently created by the Company or the Company's Affiliates after the Effective Date (including where Selection Patent Rights or Pyrrolidine Patent Rights are also implicated in the proceedings, provided however that the settlement negotiations only concern, or that a settlement is only entered into with respect to, the Company Arising Patent Rights or the Patent Rights covering inventions independently created by the Company or the Company's Affiliates after the Effective Date).", "": "" }, { "Text": "2.31. Clause 14.5.2 (former) / Clause 15.5.2 (new) is replaced as follows: \"If the Company has control of the infringement proceedings, it shall have the right, but not the obligation, to defend the Revocation Counterclaim to the extent that it is in the Field, in UCB's name and at its own cost. The Company may negotiate settlements in respect of the Revocation Counterclaim provided that the Company keeps UCB informed of and consults with and obtains UCB's prior written approval of the terms of any settlement. For clarity, no such information or consultation or prior written approval shall be required to the extent the proceedings concern Company Arising Patent Rights or other Patent Rights covering inventions independently created by the Company or the Company's Affiliates after the Effective Date (including where Selection Patent Rights or Pyrrolidine Patent Rights are also implicated in the proceedings, provided however that the settlement negotiations only concern, or that a settlement is only entered into with respect to, the Company Arising Patent Rights or the Patent Rights covering inventions independently created by the Company or the Company's Affiliates after the Effective Date). UCB shall provide such assistance as the Company may from time to time reasonably request in connection with such proceedings including making available to the Company such records, information and evidence in UCB's possession or control which may be of assistance to the Company.", "": "" }, { "Text": "Consequences of Expiry or Termination", "": "" }, { "Text": "2.32. Clause 16.1.4 (former) / Clause 17.1.4 (new) is replaced as follows: \"If the Company terminates this Agreement pursuant to Clause 16.3 (termination at will) or if UCB terminates this Agreement pursuant to Clause 16.2.1 (material breach), 16.2.2 (challenge to IP), 16.2.3 (insolvency) or 16.2.4 (failure to pay), then UCB shall have the option, in its absolute discretion, to request the novation to it of any Sub-license that solely relates to one or more Licensed Products and if such option is exercised, the Company shall use commercially reasonable efforts to effect the novation of such Sub-license to UCB.", "": "" }, { "Text": "2.33. Clause 16.2.1 (former) / Clause 17.2.1 (new), is replaced as follows: \"The Company shall, at UCB's election made in writing within thirty (30) days after the effective date of termination of this Agreement (such election to be made in UCB's sole discretion), and hereby does, effective as of the date UCB provides such written election to the Company, grant UCB an exclusive, royalty-bearing (to the extent provided in Clause 17.2.2), irrevocable, perpetual, sub-licensable (through multiple tiers), transferable license under all Company Arising IP Controlled by the Company at the time of termination of this Agreement claiming or covering, technology or Know How actually used in connection with, or integrated into and is necessary for, the development, manufacture or commercialization of the UCB Licensed Compounds or Licensed Products but in each case solely with respect to such UCB Licensed Compounds or Licensed Products as they exist on the date of termination of this Agreement, and in each case excluding, and in each case excluding any license or rights under any (i) Company Arising IP with respect to any active ingredient that is not a UCB Licensed Compound and that is covered by Patents Controlled by the Company or any of its Affiliates (from time to time), and (ii) Intellectual Property Controlled by AbbVie and its Affiliates (specifically excluding the Company for purposes of this sub-paragraph (ii)) prior to the date of completion of the transaction set forth in the SPA, regardless of whether such Intellectual Property is used by AbbVie or its Affiliates to Exploit a UCB Licensed Compound or a Licensed Product or whether such Intellectual Property otherwise may meet the definition of Company Arising IP.", "": "" }, { "Text": "2.34. A new Clause 17.2 is added, causing the existing Clauses 16.2 (former) / 17.2 (new) to 16.5 (former) / Clause 17.5 (new) to be renumbered accordingly (and causing all references to such renumbered clauses to be updated accordingly): \"For clarity, if this Agreement expires in accordance with Clause 16.1.1, Clauses 17.1.1, 17.1.2 and 17.1.4 shall not apply and the licenses granted pursuant to Clause 2.1 shall become (and remain in full force and effect thereafter as) fully paid-up, perpetual and irrevocable.", "": "" }, { "Text": "2.35. Clause 16.3 (former) / Clause 17.4 (new), is replaced as follows: \"If UCB terminates this Agreement pursuant to Clause 16.2.1 (material breach), 16.2.2 (challenge to IP), 16.2.3 (insolvency) or 16.2.4 (failure to pay), then the Company shall and hereby does, effective as of the effective date of termination of this Agreement, grant UCB an exclusive, irrevocable, perpetual, royalty-free, sub-licensable (through multiple tiers), transferable license under all Company Arising IP Controlled by the Company at the time of termination of this Agreement claiming or covering, technology or Know How actually used in connection with, or integrated into and is necessary for, the development, manufacture or commercialization of the UCB Licensed Compounds or Licensed Products but in each case solely with respect to such UCB Licensed Compounds or Licensed Products as they exist on the date of termination of this Agreement, and in each case excluding any license or rights under any (i) Company Arising IP with respect to any active ingredient that is not a UCB Licensed Compound and that is covered by Patents Controlled by the Company or any of its Affiliates (from time to time), and (ii) Intellectual Property Controlled by AbbVie and its Affiliates (specifically excluding the Company for purposes of this sub-paragraph (ii)) prior to the date of completion of the transaction set forth in the SPA, regardless of whether such Intellectual Property is used by AbbVie or its Affiliates to Exploit a UCB Licensed Compound or a Licensed Product or whether such Intellectual Property otherwise may meet the definition of Company Arising IP\".", "": "" }, { "Text": "2.36. A new Clause 17.7 is added, reading as follows: \"If the Company has the right to terminate this Agreement pursuant to Clause 16.2.1 or Clause 16.2.3, in lieu of termination, the Company may elect, in its sole discretion, to continue this Agreement with the following modifications (i) all rights and licenses granted by UCB under this Agreement shall become perpetual, irrevocable and unrestricted and (ii) the Company's diligence obligations shall terminate.", "": "" }, { "Text": "General", "": "" }, { "Text": "2.37. Clause 17.4 (former) / Clause 18.4 (new) (Assignment) is replaced as follows: \"Subject to the below, neither Party (the \"Assigning Party\") shall assign or transfer this Agreement as a whole, or any of its rights or obligations under it, without first obtaining the written consent of the other Party (the \"Non-Assigning Party\"). Each Party may assign or transfer this Agreement as a whole: 18.4.1 to any of its Affiliates; or 18.4.2 to any Third Party acquirer in relation to the acquisition of all or substantially all of such Assigning Party's business and assets or in relation to the acquisition or transfer of all such Assigning Party's assets contemplated by this Agreement, provided that any such assignee agrees to be subject to the terms and conditions of this Agreement (as notified in writing by such assignee to the Non-Assigning Party, either in advance of the assignment or as soon as possible afterwards, but in any case no later than 30 days after the assignment). The assignment shall be valid whether or not such written notification has been made, provided that in accordance with Article 1690, §1, second paragraph of the Old Belgian Civil Code (\"Oud Burgerlijk Wetboek\" / \"Ancien Code Civil\"), the assignment shall only be enforceable against the Non-Assigning Party once it has received the written notification.", "": "" }, { "Text": "Schedule 3 – Royalties", "": "" }, { "Text": "2.38. Paragraph 1.10 of Schedule 3 (Royalties) is replaced as follows: \"If it is necessary for Company (or its Affiliate that is a Sub-licensee) to in-license Third Party technology in order to Exploit a Lead Compound or any Follow-On Compound and Company (or its Affiliate that is a Sub-licensee) is required to make and does make royalty payments in respect of such in-licensed technology in any country to one or more Third Parties then Company (or its Affiliate that is a Sub-licensee) may deduct from the Royalties that are otherwise due to UCB in respect of a Licensed Product containing such Lead Compound or Follow-On Compound in such country, 50% of the royalty payments paid to such Third Party up to a maximum of 50% of the Royalty payments that are otherwise due to UCB in respect of that Licensed Product in that country (\"Third Party Royalty\"), provided that the Royalty payable in respect of a Licensed Product containing a Lead Compound or any Follow-on Compound is not reduced to below 1% of Net Sales.", "": "" }, { "Text": "2.39. Paragraph 1.11 of Schedule 3 (Royalties) is replaced as follows: \"Company shall make a deduction from the Royalties due in respect of a Licensed Product in accordance with Paragraph 1.10 of this Schedule 3 from the first Royalty payment that becomes due following the payment by Company of the Third Party Royalty in respect of such Licensed Product, provided that if either cap on deductions provided in paragraph 1.10 of Schedule 3 (Royalties) is met, the difference that has not been deducted shall be carried forward to be deducted from the next Royalty payment becoming due to UCB (the \"Next Royalty Payment\") and each subsequent Next Royalty Payment, always subject to the 1% of Net Sales floor below which each such Next Royalty Payment cannot be reduced. For clarity, in case a deduction is carried forward to any of the Next Royalty Payments pursuant to the foregoing, said deduction shall be limited so that each Next Royalty Payment never drops below the 1% of the Net Sales reported with regards to the period covered by such Next Royalty Payment.", "": "" }, { "Text": "Schedule 6 – Royalty Statement", "": "" }, { "Text": "2.40. Paragraph 2.2 of Schedule 6 (Royalty Statement) is replaced as follows: \"the amount of any reductions or deductions made pursuant to Schedule 3 (Royalties), Paragraphs 1.9, 1.10 or 1.11\".", "": "" }, { "Text": "2.41. In Paragraph 4, first sentence of Schedule 6 (Royalty Statement), the reference to \"Paragraph 1.4 of Schedule 2\" is replaced by a reference to \"Paragraph 1.3 of Schedule 3 (Royalties)\".", "": "" }, { "Text": "Schedule 7 – Development Plan", "": "" }, { "Text": "2.42. Schedule 7 and Schedule 8 are deleted in their entirety.", "": "" }, { "Text": "Miscellaneous", "": "" }, { "Text": "2.43. Any reference to the \"Agreement\" in the License Agreement shall be construed as a reference to the License Agreement as amended pursuant to this Amendment Agreement.", "": "" }, { "Text": "3. REGISTRATION OF THE UCB LICENSE AGREEMENT", "": "" }, { "Text": "3.1. UCB agrees and acknowledges that the Company is entitled to register and/or record the License Agreement (as amended pursuant to this Amendment Agreement) with any and all relevant patent offices (including with the European Patent Office (EPO), the UK Intellectual Property Office and the United States Patent and Trademark Office (USPTO)) and shall provide all necessary assistance and take all steps required by the Company to enable the Company to complete such registration and/or recordation.", "": "" }, { "Text": "3.2. Without prejudice to UCB's obligations pursuant to Clause 3.1 above, UCB hereby delegates all powers to the Company, with the power to sub-delegate, to represent UCB in front of any and all patent offices for the purposes of registration of the License Agreement.", "": "" }, { "Text": "4. REPRESENTATIONS AND WARRANTIES", "": "" }, { "Text": "4.1. UCB represents and warrants that as of the date hereof:", "": "" }, { "Text": "4.1.1. UCB is not aware of any material breach of the License Agreement by the Company or other breaches which would lead to a termination right for UCB pursuant to Clauses 15.2.1, 15.2.2 and/or 15.2.4 (former) / Clauses 16.2.1, 16.2.2 and/or 16.2.4 (new) (Termination for Cause or Insolvency) of the License Agreement;", "": "" }, { "Text": "4.1.2. it has not (i) assigned or otherwise transferred the UCB Licensed IP to a Third Party, or (ii) otherwise Encumbered the UCB Licensed IP or granted any license or any other right that conflicts with the rights granted to the Company under the License Agreement; and", "": "" }, { "Text": "4.1.3. no licenses have been granted or received under, respectively, article 11.4 and article 11.6 of the License Agreement.", "": "" }, { "Text": "5. MISCELLANEOUS PROVISIONS", "": "" }, { "Text": "5.1. Incorporation by reference", "": "" }, { "Text": "The provisions of Clauses 17.1 and 17.2 (Notices), 17.5 (Illegal/unenforceable provisions), 17.8 (Costs and Expense), Clause 17.9 (Entire Agreement), Clause 17.10 (Formalities), Clause 17.11 (Amendments), Clause 17.12 (Third Parties) and Clause 17.13 (Counterparts) of the License Agreement are hereby incorporated by reference into this Agreement as if such provisions were set forth herein in full.", "": "" }, { "Text": "5.2. Governing law", "": "" }, { "Text": "This Amendment Agreement (including any dispute, controversy, proceedings or claim of whatever nature arising out of or in any way relation to it, including any non-contractual obligations) shall be governed by and construed in accordance with the laws of Belgium (excluding any conflicts or choice of law rule or principle that might otherwise refer construction or interpretation of the agreement to the substantive law of another jurisdiction).", "": "" }, { "Text": "5.3. Jurisdiction", "": "" }, { "Text": "The Parties irrevocably agree that the courts of Brussels, Belgium shall have exclusive jurisdiction to settle any dispute or claim (including non-contractual disputes or claims) arising out of or in connection with this Amendment Agreement or its subject matter or formation.", "": "" }, { "Text": "EXHIBIT A Agreed Form of Corrective Patent Assignment", "": "" }, { "Text": "IN WITNESS WHEREOF, this Amendment Agreement has been executed on behalf of the Parties.", "": "" }, { "Text": "Syndesi Therapeutics SA", "": "" }, { "Text": "Name: Jean Combalbert", "": "" }, { "Text": "Title: Chairman", "": "" }, { "Text": "Name: Morten Graugaard Døssing", "": "" }, { "Text": "Title: Partner", "": "" }, { "Text": "UCB Biopharma SRL", "": "" }, { "Text": "Name: Dhaval Patel", "": "" }, { "Text": "Title: CSO", "": "" }, { "Text": "AbbVie Global Enterprises Ltd.
4th Floor, Washington House
16 Church Street
Hamilton HM11, Bermuda
abbvie.com", "": "" }, { "Text": "20-Dec-23", "": "" }, { "Text": "Alpine Immune Sciences Inc.
188 E Blaine St Suite 200
Seattle, WA 98102
United States
Attention: Paul Rickey, CFO", "": "" }, { "Text": "Re: The Option and License Agreement between Alpine Immune Sciences Inc. (\"Alpine\" or \"Licensor\") and AbbVie Global Enterprises Ltd. (as assignee of AbbVie Ireland Unlimited Company) (\"AbbVie\"), made and entered into as of June 17, 2020, as amended by that certain letter dated April 12, 2022 (the \"Agreement\")", "": "" }, { "Text": "To Whom it May Concern:", "": "" }, { "Text": "This letter serves to memorialize the amendment of certain terms of the Agreement as set forth herein.", "": "" }, { "Text": "1. Modification of the Option Exercise Fee. The Parties agree that Section 6.4 (Option Exercise Fee) is hereby deleted and replaced in its entirety with the following:

Option Exercise Fee. Within thirty (30) days after the Option Effective Date, AbbVie shall pay Licensor a one-time payment of Ten Million Dollars ($10,000,000) (the \"Option Exercise Fee\").", "": "" }, { "Text": "2. Modification of Certain Payments. The Parties agree that, notwithstanding anything to the contrary in the Agreement:
a. the amount of each payment payable by AbbVie to Licensor under each of Section 6.2 (Development Milestones by Licensor), Section 6.3 (Development Milestones by AbbVie), Section 6.5 (Sales-Based Milestones) or Section 6.6 (Royalties) is hereby reduced to seventy-five percent (75%) of the amount written in Section 6.2 (Development Milestones by Licensor), Section 6.3 (Development Milestones by AbbVie), Section 6.5 (Sales-Based Milestones) or Section 6.6 (Royalties), as applicable;", "": "" }, { "Text": "accordingly, for purposes of example, the amount payable by AbbVie to Licensor under Section 6.3 (Development Milestones by AbbVie) for the occurrence of the first development milestone (i.e., Initiation of the first Phase III for a Licensed Product for an Indication other than aGVHD) shall be $30,000,000 not $40,000,000 as written; and", "": "" }, { "Text": "b. the third development milestone in Section 6.2 (Development Milestones by Licensor) is in its entirety hereby deleted from the Agreement in its entirety and will not be payable by AbbVie.", "": "" }, { "Text": "3. New Analysis. Alpine will stop enrollment of any new patients in the Phase II SLE Clinical Study within thirty (30) days of the date of this letter and will conduct a final analysis after the last patient enrolled in the Phase II SLE Clinical Study as of the date of this letter has completed the study protocol (the \"New Analysis\"). An approximate timeline for the New Analysis is set forth in Exhibit B. Alpine agrees to perform a test or preliminary analysis prior to performing the New Analysis, no later than 4 months before planned final analysis.", "": "" }, { "Text": "4. Data Package. Based on the New Analysis, Alpine agrees to provide AbbVie with a data package containing at least the elements set forth in Exhibit B to this letter, including without limitation all patient level data in a format reasonably acceptable to AbbVie New Analysis Data Package. a complete New Analysis Data Package New Analysis Data Package Delivery Date Data Package, request access to all Information previously generated in the performance of the activities set forth in the Development Plan (which Alpine shall provide to AbbVie as soon as practicable following such request), and to ask questions of and receive timely answers from Alpine related thereto. Alpine agrees that its provision o", "": "" }, { "Text": "5. AbbVie Review. AbbVie may, in its sole discretion, exercise the Option by providing written notice of such to Alpine no later than ninety (90) days after the New Analysis Data Package Delivery Date (such period, New Analysis Review Period notice to Alpine that it does not believe the New Analysis Data Package provided contains the required information then (a) the New Analysis Review Period shall be tolled, (b) Alpine shall provide to AbbVie an updated New Analysis Data Package containing the required information as promptly as practicable, and (c) the New Analysis Review Period shall continue following the date of delivery of the updated New Analysis Data Package containing the required information; provided that if Licensor in good faith believes that the New Analysis Data Package is complete after the first extension, then the dispute shall be handled as set forth in Section 13.7 (Dispute Resolution). If the resolution of such dispute is that the New Analysis Data Package is complete, the New Analysis Data Package shall be deemed to be complete, and the New Analysis Review Period shall expire on the later of: (i) the expiration date of the original New Analysis Review Period, as tolled under clause (a) of this Paragraph 5 above, and (ii) sixty (60) days following the date that the Parties receive written notice of such decision.", "": "" }, { "Text": "6. Non-Exercise of Option. In the event that AbbVie does not exercise the Option during the New Analysis Review Period, the Agreement will terminate without any action of either Party on the first day following the New Analysis Review Period pursuant to Section 12.1(a), with consequences as set forth in the Agreement.", "": "" }, { "Text": "7. Public Announcements. Notwithstanding Section 9.5 of the Agreement, Alpine shall not issue any other written co Applicable Law or the rules of a stock exchange on which its securities are listed.", "": "" }, { "Text": "8. Miscellaneous. The Agreement shall remain in full force and effect except as expressly modified by this letter. This letter constitutes the entire understanding between the Parties with respect to the amendment of the Agreement, and supersedes all prior understandings, both written and oral, between the Parties with respect thereto.", "": "" }, { "Text": "Capitalized terms used in this letter have the meanings set forth in the Agreement. Unless otherwise specified, section references in this letter refer to the applicable section in the Agreement. This letter will be effective upon execution by each of the parties.", "": "" }, { "Text": "Please countersign this letter below and return a copy to AbbVie. If you have any questions regarding this letter, please contact John Larson, Senior Director, Alliance Management, at (847) 935-8190.", "": "" }, { "Text": "Sincerely,", "": "" }, { "Text": "AbbVie Global Enterprises Ltd.
Name:
Title:", "": "" }, { "Text": "Agreed:

Alpine Immune Sciences Inc.
Name: Paul Rickey
Title: CFO", "": "" }, { "Text": "Exhibit A

Illustrative Timeline for Final Analysis", "": "" }, { "Text": "Exhibit B

New Analysis Data Package", "": "" }, { "Text": "The New Analysis Data Package shall include all Clinical Data, including: ALPN-101 Clinical Data, Regulatory Documentation and other Information resulting from the Development Activities or the aGVHD Clinical Study conducted on or prior to (i) in the case of Clinical Information (as defined below), the New Analysis Data Package Trigger Event and (ii) in the case of all other Information, the delivery of the New Analysis Data Package, including the following:", "": "" }, { "Text": "Clinical Studies:
All the clinical information for Clinical Study AO3 and AO3a conducted under the Development Plan and the Clinical Information
• Protocol and all amendments
o CRF/aCRF, SAP
o All SDTM datasets and specs
o All ADaM datasets and specs, production SAS programs, QC documentation and SAS programs
o All TFLs, production SAS programs, QC documentation and SAS programs
• Dose recommendation along with the justification, if applicable
• Aggregate safety data, safety reports and any safety monitoring committee minutes, recommendations, and charters
• Study conduct metrics (including patient enrollment data, site activation, data collection & cleaning metrics, site monitoring plan) CSR (after opt-in)", "": "" }, { "Text": "Clinical PK, Immunogenicity, and Biomarker data:
Summary and individual subject-level data for PK, PD (including target engagement and downstream PD biomarkers as indicated below), anti-drug antibodies, and neutralizing antibodies.

• Target Saturation (combined CD28/ICOS)
• Change in SLE biomarkers (e.g., total IgM and IgG, Complement C3/C4, ANA and anti-dsDNA)
• Change in peripheral blood numbers and frequencies of T cells, B cells, NK cells and Monocytes (Trucount TBNKMo assay)
• Change in peripheral blood numbers and/or frequency of peripheral blood T and B cell subpopulations by immunophenotyping
• Change in soluble CD28 and ICOS and their ligands
• Additional exploratory biomarker analysis to inform on PD and MOA as deemed necessary by the Joint Governance Committee
• Biomarker methods reports and summaries, including validation reports", "": "" }, { "Text": "Non-Clinical:

Nonclinical and Bioanalytical reports
• Bioanalytical methods reports and summaries, including validation reports for quantitation of ALPN-101, ADA and nAb (as appropriate)
• Standard for Exchange of Nonclinical Data (SEND)-compliant toxicology reports and data sets for 6M toxicity study, resulting from the Initial Development Activities conducted in accordance with Good Laboratory Practice", "": "" }, { "Text": "CMC:

Development reports (Cell line, Formulation, Process) for both Process A and Process B:
• Reports for completed activities for cell line development to include: Cell line development including plasmid construction and history of the parental cell line, Clonal cell line generation, Cell line screening and selection, MCB production and characterization, MCB Certificate of Analysis, Executed batch record for MCB
• Viral clearance study report (or study data collected to date if report is not fully generated)
• Reports from DS/DP manufacturing process development experiments demonstrating conditions/resins/parameter evaluation leading to the Phase I/IIGMP process
• Reports from manufacture and testing of Non-GMP batches (including, but not limited to, scale up batches, small scale engineering batches, at scale engineering batches, and GLP toxicology batches)
• Reports from DS/DP hold-time studies to support at-scale process holds and excursions
• Reports covering reference standard manufacture
• Reports from DS and DP formulation development experiments including studies at stressed storage conditions that led to the selected Phase IIa/IIb DS and DP formulation and container closure
• Manufacturing campaign reports, summaries, and investigations/deviations; to include release data, stability, and CofAs for each DS and DP GMP batch
• Comparability reports to cover manufacturing/formulation/tox material changes", "": "" }, { "Text": "Analytical reports for both Process A and Process B materials:
• Reports including identification and qualification of impurities (process-related or product-related impurities)
• Reports covering reference standard characterization, qualification and stability
• Completed report(s) documenting characterization results to include physicochemical, biophysical, and biological tests sufficient to characterize the primary structure, secondary structure, tertiary structure, aggregates and fragments, other degradation pathways (e.g., oxidation, deamination), post-translational modifications, purity, product variants, product-related impurities, glycosylation profile, CD28-ICOS binding activity, CD28-ICOS inhibition activity, and Fc receptor binding properties of ALPN-101.
• SOPs and reports for establishment of QC test methods, to include: test method SOPs, test method development reports, test method validation reports, method robustness assessment
• Product-specific Host Cell Protein (HCP) method development and/or qualification reports
• Reports and documentation supporting establishment of the cell-based bioassay (process A and B), to include: method development and validation reports of the cell-based bioassay
• Reports and documentation supporting establishment of the validated, stability-indicating CD28-ICOS inhibition assay for potency measurement, to include: Method development and validation reports
• Stability study reports", "": "" }, { "Text": "All CRO agreements, data and reports and GxP quality agreements and audits.

• Regulatory Documentation
o Pre-IND FDA Briefing Package, preliminary comments, minutes
o Briefing packages, preliminary comments, minutes for all other FDA consultations
o Briefing Packages, presentations, preliminary queries, minutes of consultations with global health authorities.
o IND/ CTA submissions and approvals
o All IND module 3 documentation and all Quality IMPD documentation submitted to health authorities in support of clinical trials
o FDA and global health authority correspondences
o Ad-hoc Pre-clinical, Clinical, CMC submissions including CSRs, SAP, module 3 updates", "": "" }, { "Text": "Execution Copy
Confidential

1

RESEARCH COLLABORATION AND LICENSE AGREEMENT

between

BIGHAT BIOSCIENCES, INC.

and

ABBVIE MANUFACTURING MANAGEMENT UNLIMITED COMPANY

Dated as of December 1, 2023", "": "" }, { "Text": "TABLE OF CONTENTS

ARTICLE 1 DEFINITIONS ........................................................................................................ 1
ARTICLE 2 RESEARCH COLLABORATION MANAGEMENT ......................................... 25
2.1 Joint Research Committees ................................................................................... 25
2.2 Working Groups.................................................................................................... 27
2.3 General Provisions Applicable to each JRC and Working Group ........................ 27
2.4 Discontinuation of a JRC or Working Group ....................................................... 30
2.5 Interactions Between a JRC and Internal Teams .................................................. 30
2.6 Expenses ............................................................................................................... 31
...", "": "" }, { "Text": "ARTICLE 1 DEFINITIONS", "": "" }, { "Text": "1.1 \"AbbVie\" has the meaning set forth in the preamble hereto.", "": "" }, { "Text": "1.2 \"AbbVie Antibody\" means any of the AbbVie APTA Antibodies and the AbbVie CD3 Antibody Constructs.", "": "" }, { "Text": "1.3 \"AbbVie Antigen Target\" means any of the: (a) initial Antigen Targets set forth on Schedule 1.3, and (b) additional Antigen Targets selected by AbbVie pursuant to Section 4.2.2(f).", "": "" }, { "Text": "1.4 \"AbbVie APTA Antibody\" means any Antibody that: (a) contains or constitutes: (i) an APTA Collaboration Antibody or an APTA Starter Antibody or (ii) any derivative, variant, fragment or altered, modified or improved form of such APTA Collaboration Antibody or APTA Starter Antibody; and (b) is Directed to Phospho-Tau, alone or in combination with one (1) or more other Targets.", "": "" }, { "Text": "1.5 \"AbbVie APTA Collaboration Product\" means any AbbVie APTA Product that contains an APTA Collaboration Antibody.", "": "" }, { "Text": "[Continuing through the remaining definitions in Article 1]", "": "" }, { "Text": "ARTICLE 2 RESEARCH COLLABORATION MANAGEMENT", "": "" }, { "Text": "2.1 Joint Research Committees.
2.1.1 APTA Joint Research Committee. Within thirty (30) days after the Effective Date, the Parties shall establish a joint research committee with respect to the APTA Research Program (the \"APTA JRC\") to serve as the oversight and decision-making body for the activities to be performed by the Parties pursuant to the APTA Research Plan and Sections 4.1 and 4.3.2 of this Agreement, as more fully described in this ARTICLE 2...", "": "" }, { "Text": "[Continuing through the remaining sections of the Agreement]", "": "" }, { "Text": "AbbVie Antigen Targets
1. TMPRSS4 (UniProt ID: Q9NRS4)
2. NaPi2B (UniProt ID: O95436)
3. TROP2 (UniProt ID: P09758)
...[Additional targets listed]", "": "" }, { "Text": "BigHat Antigen Targets
1. CDH17 (UniProt ID: Q12864)
2. CEACAM6 (UniProt ID: P40199)
...[Additional targets listed]", "": "" }, { "Text": "Excluded Antigen Targets
1. CELSR3 (UniProt ID: Q9NYQ7)
2. EGFR (UniProt ID: P00533)
...[Additional targets listed]", "": "" }, { "Text": "APTA Research Plan
Generating High Affinity and Selective Anti Pathological Tau Antibodies

SCOPE OF THE COLLABORATION
The scope of this collaboration is to generate optimized Anti Pathological Tau Antibodies (APTA) with high affinity and selectivity for specific Tau phosphosites and excellent biophysical properties as well as an ability to interfere with the cell-to-cell propagation of pathological Tau in in vivo models...", "": "" }, { "Text": "CD3 Research Plan
Discovery and Optimization of Novel anti-CD3 Antibodies for Next Generation T-Cell Engagers

SCOPE OF THE COLLABORATION
The scope of this collaboration is to discover and develop a diverse panel of fully-human anti-CD3 IgG and VHH domain antibodies with a >1,000-fold range of affinities from low nM KD and up...", "": "" }, { "Text": "Form of Press Release
AbbVie and BigHat Biosciences Announce Research Collaboration to Leverage AI/ML to Discover Next-Generation Therapeutic Antibodies
December 5, 2023
- Collaboration to leverage BigHat's AI/ML (Artificial Intelligence / Machine Learning) guided Milliner™ platform and AbbVie's expertise in Oncology and Neuroscience, to develop high quality next-generation antibodies...", "": "" }, { "Text": "Existing Patents
[Patent application details listed]", "": "" }, { "Text": "ADR Procedures
Any Dispute referred to ADR under this Agreement shall be resolved as follows:
1. To begin an ADR proceeding, a Party shall provide written notice to the other Party of the Dispute to be resolved by ADR...", "": "" }, { "Text": "Confidential Execution Version onfidentia TRANSITION AGREEMENT This Transition Agreement (this \"Transition Agreement\"), dated as of August 1, 2022 (the \"Transition Effective Date\"), is by and among AbbVie Global Enterprises Ltd., a Bermuda corporation (\"AbbVie\"), and BioArctic AB, a Swedish limited liability company with corporate reg, no 556601- 2679 (\"BioArctic\"), AbbVie and BioArctic may each be referred to herein individually as a \"Party\" and collectively as the \"Parties\".", "": "" }, { "Text": "WHEREAS, AbbVie's Affiliate AbbVie Ireland Unlimited Company and BioArctic previously entered into that certain Research, Development, Option and License Agreement, dated as of September 15, 2016 (the \"Collaboration Agreement\"), pursuant to which (i) AbbVie and BioArctic established an alliance to discover, develop, and commercialize novel medicines for ncurodegencrative diseases, and (ii) BioAretic granted AbbVie an exclusive option to obtain an exclusive license to develop and commercialize Licensed Products;", "": "" }, { "Text": "WHEREAS, AbbVie [reland Unlimited Company assigned and transferred the Collaboration Agreement to AbbVie pursuant to Section 13.5.1 of the Collaboration Agreement;", "": "" }, { "Text": "WHEREAS, AbbVie exercised its Option under the Collaboration Agreement on October 30, 2018 to Exploit the Licensed Compounds and Licensed Products;", "": "" }, { "Text": "WHEREAS, AbbVic issued notice to BioArctic of its desire to terminate the Collaboration Agreement in its entirety effective on July 19, 2022 pursuant to Section 12.3.2 of the Collaboration Agreement;", "": "" }, { "Text": "WHEREAS, on 22 April, 2022, BioArctic issued notice to AbbVie of its desire to exercise the Grantback Option pursuant to Section 12.6.1 of the Collaboration Agreement;", "": "" }, { "Text": "WHEREAS, the Partics now desire to enter into this written transition agreement pursuant to Section 12.8 of the Collaboration Agreement, and settle all rights and obligations resulting from, and in connection with, the Collaboration Agreement under the terms and conditions of this Transition Agreement; and", "": "" }, { "Text": "NOW, THEREFORE, in consideration of the mutual covenants, conditions and agreements contained herein, including the recitals set forth above, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:", "": "" }, { "Text": "I. Definitions.", "": "" }, { "Text": "1.1. Capitalized terms used herein that are not otherwise defined herein shall have the meanings ascribed to such terms in the Collaboration Agreement. Unless specifically provided herein, the following terms shall have the following meanings:", "": "" }, { "Text": "1.2, \"AbbVie Grantback Know-How\" means that certain AbbVic Know-How that (i) is Controlled by AbbVic or any of its Affiliates as of the Transition Effective Date, (ii) is not generally known, (iii) is solely directed to the composition or formulation of, or the method of using, or otherwise solely and directly related to a Grantback Product, (iv) is transferred by AbbVie to BioArctic pursuant to Section 4 herein, and (v) has actually been used by AbbVie or its Affiliates or Sublicensees in the Development or Manufacture of a Licensed Product which contains a Licensed Compound as the sole active ingredient pursuant to the Collaboration Agreement as such Licensed Product exists as of the Transition Effective Date.", "": "" }, { "Text": "1.3. \"First Commercial Sale\" means with respect to a Grantback Product and a country, the first sale for monetary value for use or consumption by the end user of such Granthack Product in such country after Regulatory Approval for such Grantback Product has been obtained in such country. Sales prior to receipt of Regulatory Approval for such Grantback Product, such as or including so-called \"treatment IND sales,\" \"named patient sales,\" and \"compassionate uscr sales,\" shall not be construed as First Commercial Sale.", "": "" }, { "Text": "1.4, \"Grantback Compound\" means (i) the compound known as BAN0805, a humanized monoclonal antibody targeting a-synuclein protofibrils that has the amino acid sequence set forth on Schedule 1.98 of the Collaboration Agreement, and (ii) any variant or derivative made from the foregoing that targets a-synuclein, including chimeric, humanized, or fully human antibodies and antigen-binding fragments, bispecific antibodies and antibodies of a different class or subclass, or any antigen-binding fragment or functional domain of such variant or derivative that targets a-synuclein; provided that in the case of (ii) above, either (y) as such Grantback Compound exists as of the Transition Effective Date, or (z) to the extent any variant or derivative of the foregoing incorporates, or its Development makes use of, any of the AbbVie Grantback Know-How.", "": "" }, { "Text": "1.5. \"Grantback Product\" means any product, or portion thereof, containing a Grantback Compound. Grantback Product includes any and all finished forms, presentations, delivery systems, strength, dosages, and formulations.", "": "" }, { "Text": "1.6. \"Grantback Royalty Term\" means, with respect to each Grantback Praduct and each country or other jurisdiction in the Territory, the period beginning on the date of First Commercial Sale of such Grantback Product in such country or other jurisdiction, and ending on the tenth (10\") anniversary of the First Commercial Sale of such Grantback Product in such country or other jurisdiction; provided that such period shall not continue beyond the Grantback Royalty Term Expiration.", "": "" }, { "Text": "1.7. \"Grantback Royalty Term Expiration\" means the fifteenth (15\") anniversary of First Commercial Sale of the first Grantback Product.", "": "" }, { "Text": "1.8. \"Term\" shall have the meaning set forth in Section 6.1.", "": "" }, { "Text": "2. Termination; Release of Claims.", "": "" }, { "Text": "2.1. Termination; Surviving Rights. The Parties hereby terminate the Collaboration Agreement in its entirety with immediate effect. Termination of the Collaboration Agreement as sct forth in this Section 2.1 shall be without prejudice to any rights that shall have accrued to the benefit of a Party prior to such termination, and such termination shal! not relieve a Party from any obligations that are expressly indicated to survive termination of the Collaboration Agreement, including pursuant to Section 12.11 thereof. In addition to the rights and obligations set forth herein, all provisions in the Collaboration Agreement that are intended to survive termination of the Collaboration Agreement, whether expressly or by reasonable implication from their nature, or that are necessary for the interpretation or cnfarcement of this Transition Agreement, shall survive mutatis mutandis in accordance with the terms thereof, except for Sections 3.7.1(v), 3.9.3. 7.7, 9.1, 12.1-12.10 and 13.2 of the Collaboration Agreement.", "": "" }, { "Text": "2.2. Mutual Release of Claims.", "": "" }, { "Text": "2.2.1 The Parties and their respective Affiliates and representatives hereby acquit. remit, discharge and forever release the respective other Party and their past, present or future successors. Affiliates, agents. representatives, shareholders, officers, directors, managers. agents and employees from any and all Released Liabilities. For the purposes of this Transition Agreement, \"Released Liabilities\" shall mean any and all claims, dues, debts, bonds, bills, sums of money, suits, reckonings, contracts, obligations, Third Party costs and expenses, controversies, covenants, agreements, promises, variances, trespasses, judgments, executions, damages, losses, remedies, responsibilities. indemnities, guarantees and accounts of whatever kind, nature or description, direct or indirect, in contract, or in tort, or otherwise, whether known or unknown, arising under or in connection with the Collaboration Agreement on or before the Transition Effective Date, including, without limitation, the termination thereof.", "": "" }, { "Text": "2.2.2. In connection with the foregoing waiver, each Party acknowledges that it is aware that it, or its attorneys or others, may hereafter discover claims or facts in addition to or different from those it now knows or believes to exist with respect to the subject matter of this release but that it is nevertheless such Parties' intention to fully, finally and forever settle, release, waive and discharge all of the Released Liabilities. The release granted herein shall remain in effect as a full and complete general release, notwithstanding the discovery or existence of any such additional or different claims or facts.", "": "" }, { "Text": "3. License Grant and Royalty,", "": "" }, { "Text": "3.1. Grantback License. AbbVie shall, and hercby does effective as of the Transition Effective Date, grant BioArctic an exclusive (including with regard to AbbVic and its Affiliates), royalty-bearing license, with the right to grant multiple ticrs of sublicenses, under the AbbVic Grantback Know-How to Exploit any Grantback Product in the Territory.", "": "" }, { "Text": "3.2. No AbbVie Grantback Patents. As of the Transition Effective Date, the Parties acknowledge that neither AbbVie nor its Affiliates Control any Abb Vie Grantback Patents.", "": "" }, { "Text": "3.3. Royalty. In consideration of the licenses granted to BioArctlic pursuant to Section 3.1 and any other promise made by AbbVie pursuant to this Transition Agreement, subject to Section 3.7 below and Section 6.4.3 of the Collaboration Agreement, BioArctic shall pay to Abb Vie, on a Grantback Product-by-Grantback Product basis, a royalty on Net Sales of such Grantback Product in the Territory (excluding Net Sales of each such Grantback Product in any country or other jurisdiction in the Territory for which the Grantback Royalty Term for such Grantback Product in such country or other jurisdiction has expired) at a rate of two percent (2%) of Net Sales.", "": "" }, { "Text": "3.4. Grantback Royalty Term. Notwithstanding anything to the contrary in this Transition Agreement, BioArctic shall have no obligation to pay any royalty with respect to Net Sales of any Grantback Product in any country or other jurisdiction after the Grantback Royalty Term.", "": "" }, { "Text": "3.5. Royalty Payments and Reports. BioArctic shall calculate all amounts payable to AbbVic pursuant to Section 3.3 at the end of each Calendar Quarter, which amounts shall be converted to Dollars in accordance with Section 6.6 of the Collaboration Agreement. BioArctic shall pay to AbbVic the royalty amounts duc with respect to a given Calendar Quarter within ninety (90) days after the end of such Calendar Quarter. Each payment of royalties due to AbbVie shall be accompanied by a statement of the amount of Net Sales of the Grantback Product in each country or other jurisdiction of the Territory during the applicable Calendar Quarter (inchiding such amounts expressed in local currency and as converted to Dollars), the quantity of Grantback Product sold, and a calculation of the amount of royalty payment due on such Net Sales for such Calendar Quarter.", "": "" }, { "Text": "3.6. Interest. on Late Payments, If any payment due to either Party under this Transition Agreement is not paid when due, then such paying Party shall pay interest thereon (before and after any judgment) at an annual rate (but with interest accruing on a daily basis) of one hundred (100) basis points above Secured Overnight Financing Rate (SOFR), such interest to run from the date on which payment of such sum became due until payment thercof in full together with such interest.", "": "" }, { "Text": "3.7. In General. For purposes of this Section 3, the definitions of \"Combination Product\" and \"Net Sales\", and Sections 6.4.3, 6.5-6.8, and 6.10-6.14 of the Collaboration Agreement shall survive and apply statis mutandis to the calculation, reductions, payment, recording, and auditing of BioArctic's obligations to pay royalties under this Section 3 as they applied to AbbVie prior to the Transition Effective Date and. solely for such purpose, each reference in each such Section (and any related definitions) to (i) Licensed Compound shall be deemed to be a reference to Grantback Compound, (ii) Licensed Product shall be deemed to be a reference to Grantback Product, (iii) Royalty Term shall be deemed to be a reference to Grantback Royalty Term, (iv) AbbVie shall be deemed to be a reference to BioArctic, and vice versa, and (v) a Sublicensee shall be deemed to be a reference to a licensee or sublicensee of BioArctic or its Affiliates.", "": "" }, { "Text": "4 'Transition Assistance,", "": "" }, { "Text": "41 Transition Period. During the one hundred eighty (180) day period following the Transition Effective Date ('The Transition Period\"), and within the timelines set forth below, Abb Vie shall use reasonable efforts to promptly perform those activities set forth in this Section 4. Except where explicitly stated otherwise herein, AbbVie shail have no obligation to perform activities pursuant to this Section 4 after the Transition Period.", "": "" }, { "Text": "4.2 FTE Hours, AbbVie shall invoice BioArctic monthly for the documented costs of providing any assistance in connection with this Section 4, including the FTE costs (the rates for which will be AbbVie's standard FTE rates for the personnel providing such assistance) and documented out-of-pocket costs payable to Third Parties; provided that the first five-hundred (500) hours of aggregate FTE assistance will be provided at no cost to BioArctic, BioArctie shall pay AbbVie the amount set forth in such invoice in United States Dollars within thirty (30) days of receipt thereof.", "": "" }, { "Text": "4.3 Transfer of Regulatory Documentation. Where permitted by Applicable Law, AbbVie shall transfer to BioArctic all of its right, title and interest in all Clinical Data and Regulatory Documentation sct forth on Schedule 4,3, to the extent such Clinical Data and Regulatory Documentation is (i) Controlled by Abb Vie or its Affiliates and (ii) applicable to a Grantback Product. The transfer of all Clinical Data and Regulatory Documentation set forth on Schedule 4.3 shall commence promptly upon the Transition Effective Date.", "": "" }, { "Text": "44 Transfer of IND. Without prejudice to the generality of AbbVie's obligations under Section 4.3, AbbVie shall promptly notify the applicable Regulatory Authorities and take any other action reasonably necessary to effectuate such transfer, including the submission of a letter to the FDA, with a copy to BioArctic, stating that all rights to the United States IND 140404 have been transferred to BioArctic.", "": "" }, { "Text": "45 Regulatory. AbbVie shall reasonably cooperate with BioArctic in the event of an inquiry from a Regulatory Authority solely and directly related to a Grantback Product and make appropriate employecs and representatives available for meetings with BioArctic (or its Affiliates or its designee, as applicable) as required for responding to such inquiry; at BioArctic's sole cost and expense. Notwithstanding anything to the contrary contained in this Section 4, the obligations set forth in this Section 4.5 shall remain in effect for up to three (3) years unless this Transition Agreement is terminated earlier in accardance with Section 7.", "": "" }, { "Text": "4.6 Manufacturing. With respect to assisting BioArctic's efforts to oblain a continued supply of Grantback Compound and Grantback Product for the conduct of Development, Manufacturing and Commercialization activities, upon BioArctic's written request:", "": "" }, { "Text": "4.6.1 AbbVie shall make available to BioArctic (or its Affiliate or designee, as applicable) from time to time as BioArctic may reasonably request, Manufacturing-related AbbVic Grantback Know-How and related materials solely and directly relating to the process (as it exists on Transition Effective Date) for the Manufacture of Grantback Compound and Grantback Product (the \"Grantback Manufacturing Process').", "": "" }, { "Text": "4.6.2 AbbVie shall (i) make appropriate employees and representatives available for meetings with BioArctic (or its Affiliates or its designee, as applicable), and (ii) provide advisement that is reasonably necessary or useful to enable BioArctic (or its Affiliate or designee, as applicable) to use and practice the Grantback Manufacturing Process; in each case ({i)-(ii)) at BioArctic's sole cost and expense.", "": "" }, { "Text": "4.6.3 The Parties agree to enter into any quality agreements required by AbbVic to perform its obligations set forth in this Section 4 and as required by BioArctic for Exploitation of the Inventory (as defined in Section 4.8 below), on reasonable and customary terms for those types of agreements,", "": "" }, { "Text": "4.6.4 Notwithstanding anything to the contrary contained in this Section 4, (i) the obligations set forth in Section 4.6.2 shall remain in effect for up to three (3) years unless this Transition Agreement is terminated earlier in accordance with Section 7, and (ii) AbbVie shall not be required to Manufacture or have Manufactured any Grantback Compound or Grantback Produet by or on behalf of BioArctic as part of the transition assistance pursuant to this Transition Agreement.", "": "" }, { "Text": "4,7 Pharmacokinetic and Toxicology Transfer. AbbVie shall promptly transfer to BioArctic all the pharmacokinetic and toxicalogy information set forth on Schedule 4.7 that is the subject of the license grant in Section 3.1; provided that, AbbVie shall be entitled to retain copies of such items to the extent required under Applicable Law for legal archival and regulatory purposes.", "": "" }, { "Text": "4.8 Inventory and Supporting Documentation Transfer. Abb Vie shall transfer to BioArctic or its designee existing inventories of the Grantback Compound and Grantback Product, including portions thereof, (the \"Inventory\") as sct forth on Schedule 4.8; provided that AbbVie shall have no obligation to tanster any Inventory that is identified on Schedule 4.8 as being the possession of any Third Party as of the Transition Effective Date until the necessary approvals from such Third Party to transter such Inventory to BioArctic have been received. Notwithstanding anything to the contrary in' this Transition Agrcement, the title of the Inventory set forth on Schedule 4.8 will be transferred from AbbVie to BioArctic as of the date when such Inventory is delivered to BioArctic or its designee in accordance with this Section 4.8. The above transfer of the Inventory shall be free of charge, and be delivered to BioArctic or its designee DDP (Incoterms 2020).", "": "" }, { "Text": "4.9 Transfer of BioArctic Patent Files. ete. After the Transition Effective Date, AbbVie shall (i) cooperate with BioArctic to transfer responsibility for filing, prosecution, and maintenance of the BtoArctic Patents to the law firm(s) and lawyer(s) specified by BioArctic, and (ii) provide a copy of those documents in AbbVie's possession that relatc to the filing, prosecution, maintenance of the BioArctic Patents, to the extent not already disclosed in accordance with clause (i) above.", "": "" }, { "Text": "4.10 Final Invoice. AbbVie shall within ninety (90) days following the expiry of the Transition Period, submit its final invoice to BioArctic for matters related to the filing, prosecution, and maintenance of BioArclic Patents and the assistance provided by AbbVie or its Affiliates under this Section 4 during the Transition Period (the \"Final Invoice Date\"). Except where explicitly stated otherwise herein, BioArctic is not liable for, and AbbVie may not make any claim for payment in respect of costs related to filing, prosecution, and maintenance of BioArctic Patents and the assistance provided by AbbVie or its Affiliates under this Section 4 after the Final Invoice Date unless otherwise specifically agreed in writing between the Parties.", "": "" }, { "Text": "5 Clinical Study Reports.", "": "" }, { "Text": "5.1 BioArctic Responsibilities. Promptly after the Transition Effective Date, BioArctic shall use reasonable efforts to @) complete a Clinical Study Report for the M19-034 Phase", "": "" }, { "Text": "5.2 AbbVic, being the sponsor of the Phase", "": "" }, { "Text": "5.3 AbbVie Assistance. AbbVie shall provide reasonable assistance required to enable BioArctic to fulfill its obligations set forth in Section 5.1, including providing the necessary Clinical Data and additional information which is reasonably requested by BioArctic; provided that (i) such additional information is the subject of the license grant in Section 3.1 and (ii) such assistance will be subject to the terms and conditions outlined in Section 4.2.", "": "" }, { "Text": "6 Term,", "": "" }, { "Text": "6.1 Term, The terms of this Transition Agreement shall commence upon the Transition Effective Date and shall continue until the Grantback Royalty Term Expiration.", "": "" }, { "Text": "6.2 Effect of Expiration, After the expiration this Transition Agreement pursuant to Section 6.1, BioArctic's rights and licenses with respect to such Grantback Product in such country shall survive as a perpetual, fully-paid up, non-royalty bearing, right and license.", "": "" }, { "Text": "7 'Termination.", "": "" }, { "Text": "TL Material Breach. The Non-Breaching Party may terminate this Transition Agreement for material breach if within thirty (30) days after the Breaching Party's receipt of a Default Notice, the Breaching Party has failed to commence compliance or has failed to use diligent efforts to achieve full compliance as soon thereafter as is reasonably possible.", "": "" }, { "Text": "7.2 Termination for Bankruptcy, Insolvency or Similar Event. In the event that cither Party (i) becomes the subject, whether voluntarily or involuntarily, of any bankruptcy, insolvency, receivership or similar proceeding, (ii) makes an assignment for the benefit of creditors, (iii) appoints or suffers appointment of a receiver or trustee over substantially all of its property, (iv) proposes a written agreement of composition, arrangement, readjustment or extension of its debts, (v) proposes or is a party lo any dissolution or liquidation or otherwise ceases to do business or winds up its affairs, (vi) admits in writing its inability to meet its obligations as they fall due in the general course, or (vii) becomes subject to a warrant of attachment, execution, or distraint or similar process against substantially all of its property, then the ather Party may terminate this Transition Agreement, in whole or in part and in its sole discretion, effective immediately upon written notice to such other Party.", "": "" }, { "Text": "713 Rights in Bankruptcy.", "": "" }, { "Text": "73.1 Applicability of 11 U.S.C. § 365(n). All rights and licenses (collectively, the \"Intellectual Property\") granted by AbbVie to BioArctic under or pursuant to this Transition Agreement, are intended to be, and shall otherwise be deemed to be, for purposes of Section 365(n) of the United States Bankruptcy Code (the \"Bankruptcy Code\") or any analogous provisions in any other country or jurisdiction, licenses of rights to \"intellectual property\" as defined under Section 101(35A) of the Bankruptcy Code. The Parties agree that BioArctic, being the licensee of such Intellectual Property under this Transition Agreement. shall retain and may fully exercise all of its rights and elections under the Bankruptcy Code, including Section 365(n) of the Bankruptcy Code, or any analogous provisions in any other country or jurisdiction. All of the rights granted to BioArctic under this Transition Agrecment shall be deemed to exist immediately before the occurrence of any bankruptcy case in which AbbVie is the debtor. All payments required to be made under Section 3.3 shall be deemed \"royalties\" under the Bankruptcy Code.", "": "" }, { "Text": "7.3.2 Rights of BioArctic in Bankruptcy. If a bankruptcy proceeding is commenced by or against AbbVie under the Bankruptcy Code or any analogous provisions in any other country or jurisdiction, BioArctic shall be entitled to a complete duplicate of (or complete access to, as appropriate) any Intellectual Property and all embodiments of such Intellectual Property, which, if not already in BioArctic's possession, shall be delivered to BioArctic within five (5) Business Days of such request; provided that AbbVie is excused from its obligation to deliver the Intellectual Property to the extent AbbVie continues to perform all of its obligations under this Transition Agreement and this Transition Agreement has not been rejected pursuant to the Bankruptcy Code or any analogous provision in any other country or jurisdiction.", "": "" }, { "Text": "8 Confidentiality.", "": "" }, { "Text": "8.1 Confidentiality Obligations. At all times during the Term and for a period of ten (10) years following termination or expiration hereof in its entirety, each Party shall, and shall cause its Affiliates, or any ofits or their respective officers, directors, employees and agents to, keep confidential and not publish or otherwise disclose to a Third Party and not use, directly or indirectly, for any purpose, any Confidential Information furnished or otherwise made known to it, directly or indirectly, by the other Party, except to the extent such disclosure or use is expressly permitted by the terms of this Transition Agreement or is reasonably necessary or uscful for the performance of, or the exercise of such Party's rights under, this Transition Agreement. Notwithstanding ihe foregoing, the Parties acknowledge the practical difficulty of policing the use of information in the unaided memory of the receiving Party or its Affiliates and its and their officers, directors, employees, and agents, and as such each Party agrees that the receiving Party shall not be liable for the use by any of its or its Affiliates' officers, directors, employees, or agents of specific Confidential Information of the disclosing Party that is retained in the unaided memory of such officer, director, employee or agent; provided that (a) such officer, director, employee, or agent is not aware that such Confidential Information is the confidential information of disclosing Party at the time of such use; (b} the foregoing is not intended to grant, and shall not be deemed to grant, the receiving Party, its Affiliates, or its officers, directors, employees, and agents a right to disclose the disclosing Party's Confidential Information; and (c) such officer, director, employee, or agent has not intentionally memorized such Confidential Information for use outside this Transition Agreement. Notwithstanding the foregoing, to the extent the receiving Party can demonstrate by documentation or other competent proof, the confidentiality and non-use obligations under this Section 8.1 with respect to any Confidential Information shall not include any information that:", "": "" }, { "Text": "8.1.1 has been published by a Third Party or otherwise is or hereafter becomes part of the public domain by public use, publication, general knowledge or the like through no wrongful act, fault or negligence on the part of the receiving Party:", "": "" }, { "Text": "8.1.2 has been in the receiving Party's possession prior to disclosure by the disclosing Party without any obligation of confidentiality with respect to such information;", "": "" }, { "Text": "8.1.3 is subsequently received by the receiving Party from a Third Party without restriction and without breach of any agreement between such Third Party and the disclosing Party:", "": "" }, { "Text": "8.1.4 is generally made available to Third Parties by the disclosing Party without restriction on disclosure; or", "": "" }, { "Text": "8.1.5 has been independently developed by or for the receiving Party without reference to, or use or disclosure of, the disclosing Party's Confidential Information,", "": "" }, { "Text": "8.2 Permitted Disclosures. The receiving Party may disclose the disclosing Party's Confidential Information 1o the extent that such disclosure is:", "": "" }, { "Text": "8.2.1 in the reasonable opinion of the receiving Party's legal counsel, required to be disclosed pursuant to law, regulation or a valid order of a court of competent jurisdiction or other supra-national, federal, national, regional, state, provincial and local governmental body of competent jurisdiction, (including by reason of filing with securities regulators); provided that the receiving Party shall first have given prompt written notice (and to the extent possible, at least five (5) Business Days' notice) to the disclosing Party and given the disclosing Party a reasonable opportunity, at its own cost and expense, to take whatever action it deems necessary to protect its Confidential Information (for example, quash such order or to obtain a protective order or confidential treatment requiring that the Confidential Information and documents that are the subject of such order be held in confidence by such court or governmental body or, if disclosed, be used only for the purposes for which the order was issued). If no protective order or other remedy is obtained, or the disclosing Party waives compliance with the terms of this Transition Agreement, receiving Party shall furnish only that portion of Confidential Information which the receiving Party is advised by counsel is legally required to be disclosed;", "": "" }, { "Text": "8.2.2. made by or on behalf of the receiving Party to the Regulatory Authorities as required in connection with any filing, application or request for Regulatory Approval in accordance with the terms of this Transition Agreement; provided that reasonable measures shall be taken to assure confidential treatment of such Confidential Information to the extent practicable and consistent with Applicable Law;", "": "" }, { "Text": "8.2.3 made by or on behalf of the receiving Party to a patent authority as may be reasonably necessary or useful for purposes of obtaining, defending or enforcing a Patent in accordance with the terms of this Transition Agreement; provided that reasonable measures shall be taken to assure confidential treatment of such Confidential Information, to the extent such protection is available;", "": "" }, { "Text": "8.2.4 made to its or its Affiliates' financial and legal advisors who have a need to know such disclosing Party's Confidential Information and are either under professional codes of conduct giving rise to expectations of confidentiality and non-use or under written agreements of confidentiality and non-use, in each case, at least as restrictive as those set forth in this Transition Agreement; provided that the receiving Party shall remain responsible for any failure by such financial and Icgal advisors, to treat such Confidential Information as required under this Section:", "": "" }, { "Text": "8.2.5 made by AbbVie or its Alfiliates or Sublicensees to its or their advisors, consultants, clinicians, vendors, service providers or contractors as may be necessary or useful in connection with the activitics contemplated by this Transition Agreement; provided that such Persons shall be subject to obligations of confidentiality and non-use with respect to such Confidential Information substantially similar to the obligations of confidentiality and non-use of the receiving Party pursuant to this Section 8 (with a duration of confidentiality and non-use obligations as appropriate that is no less than five (5) years from the date of disclosure); or", "": "" }, { "Text": "8.2.6 made by BioArctic or its Affiliates to its or their advisors, consultants, clinicians, vendors, service providers, contractors, existing or prospective collaboration partners, licensees, sublicensees, or other Third Parties, in connection with the Exploitation of the Grantback Compound, the Grantback Products, or otherwise in connection with the performance or its rights and obligations contemplated by this Transition Agreement; provided that such Persons shall be subject to obligations of confidentiality and non-use with respect to such Confidential Information of AbbVie substantially similar to the obligations of confidentiality and non-use of BioArctic pursuant to this Section 8 (with a duration of confidentiality and non-use obligations as appropriate that is no less than five (5) years from the date of disclosure for advisors, consultants, clinicians, vendors, service providers or contractors).", "": "" }, { "Text": "8.3 It is agreed that, notwithstanding Section 1,43 of the Collaboration Agreement, all Clinical Data, Regulatory Documentation and other tangible Abb Vie Grantback Know-How transferred to and owned by or licensed to BioArctic pursuant to Section 4 shall be deemed to be the Confidential Information of BioArctic, and BioArctic shall be deemed to be the disclosing Party and AbbVie shall be deemed to be the receiving Party with respect thereto.", "": "" }, { "Text": "8.4 In General, For purposes of this Scction 8, the Sections 9.4, 9.5, 9.7, and 9.8 of the Collaboration Agreement shall survive and apply auttatis mutandis to the use of names, public announcements, disclosure of this Transition Agreement, and return of Confidential Information obligations of the Parties under this Section 8 as they applied to the Parties prior to the Transition Effective Date and, solely for such purpose, each reference in each such Section (and any related definitions) to the Collaboration Agreement shall be deemed to be this Transition Agreement.", "": "" }, { "Text": "9 Liability; Indemnity", "": "" }, { "Text": "91 No Responsibility for Prior Clinical Studies. BioArctic shall under no circumstances assume any responsibility or liability under the Collaboration Agreement or this Transition Agreement for any Clinical Studics conducted by AbbVie, its Affiliates or Sublicensecs on or before the Transition Effective Date, including for any injury to or death of any person participating in such Clinical Studies.", "": "" }, { "Text": "9.2 Indemnification of AbbVie. BioArctic shall indemnify AbbVie, its Affiliates and their respective directors, officers, employees, and agents (the \"AbbVie Indemnitces\") and shall defend and save each of them harmless, from and against any and all losses, damages, liabilities, penalties, costs, and expenses (including reasonable attorneys' fees and expenses) (collectively, \"Losses\") in connection with any and all suits, investigations, claims, or demands of Third Parties (collectively, \"Third Party Claims\") incurred by or rendered against the Abb Vie Indemnitees arising from or occurring as a result of:", "": "" }, { "Text": "(i) the breach by BioArctic or its Affiliates of this Transition Agreement; (ii) the negligence, reckless conduct or willful misconduct on the part of BioArctic, its Affiliates or its Sublicensees or their respective directors, officers. employees, and agents in performing its or their material obligations under this Transition Agreement; (iii} the Development, Commercialization, Manufacture, or other Exploitation of the Grantback Product or any Grantback Compound anywhere in the world by BioArctic, its Affiliates or Sublicensees, in each case, after the Transition Effective Date and during the Term thereafter, including any products liability claims and any claims for infringement, misappropriation or other violation of any Patent or other intellectual property rights; and (iv) the infringement of any Patent or other intellectual property or other proprietary rights of any Third Party arising from BioArctic's or any of its Affiliates' Development, Commercialization, Manufacture or other Exploitation of the Grantback Product or any Grantback Compound, whether prior to or after the Transition Effective Date; except in the case of clauses (i) through (iii), for those Losses for which AbbVie, in whole or in part, has an obligation to indemnify BioArctic pursuant to Section 9.3 hereof or Section 11.2 of the Collaboration Agreement, as to which Losses each Party shall indemnify the other to the extent of their respective liability for such Losses.", "": "" }, { "Text": "93 Indemnification of BioArctic. AbbVie shall indemnify BioArctic, its Affiliates and their respective directors, officers, employees, and agents (the \"BioArctic Indemmnitees\"), and defend and save each of them harmless, from and against any and all Losses in connection with any and all Third Party Claims incurred by or rendered against the BioArctic Indemnitees arising from or occurring as a result of:", "": "" }, { "Text": "(i) the breach by AbbVie or its Affiliates of this Transition Agreement; (ii) the negligence, reckless conduct or willful misconduct on the part of AbbVie, its Affiliates or its Sublicensees or their respective directors, officers, employees, and agents in performing its or their material obligations under this Transition Agreement: and except in the case of clauses (1), and (ii) for those Losses for which BioArctic, in whole or in part, has an obligation to indemnify AbbVie pursuant to Section 9.2 hereof or Section 11.1 of tbe Collaboration Agreement, as to which Losses each Party shall indemnify the other to the extent of their respective liability for such Losses,", "": "" }, { "Text": "9.4 Indemnification under the Collaboration Agreement. For the avoidance of doubt: the Parties' respective indemnification obligations in Sections 9.2 and 9.3 above are in addition to the Parties' respective surviving indemnification obligations in Sections 11.1 and 11.2 of the Collaboration Agreement.", "": "" }, { "Text": "9,5 In General. For purposes of this Section 9, the Sections 11.3, 11.4, 11.5, and 11.6 of the Collaboration Agreement shall survive and apply mutatis mutandis to the notice of claim, control of defense, calculation of Losses, and insurance obligations of the Parties under this Section 9 as they applied to the Parties prior to the Transition Effective Date and, solely for such purpose, each reference in each such Section (and any related definitions) to (7) Agreement shall be deemed to be this Transition Agreement.", "": "" }, { "Text": "10 Representations and Warranties,", "": "" }, { "Text": "Each Party represents and warrants to the other Party that (i) it has the legal right and authority to enter into this Transition Agreement and to perform all duties and obligations under, or in connection with, this Transition Agreement, (ii) the entering into and the performance of this Transition Agreement does not and will not infringe any law, regulation, license or authority to which such Party is subject and (iii) the persons signing this Transition Agreement for and on behalf of such Party are properly authorized to do so.", "": "" }, { "Text": "lJ Miscellaneous Provisions.", "": "" }, { "Text": "11.1 Severability. If any provision of this Transition Agreement is held to be illegal, invalid or unenforceable under any present or future law, and if the rights or obligations of cither Party under this Transition Agreement will not be materially and adversely affected thereby, (i) such provision shall be fully severable, (ii) this Transition Agreement shall be construed and enforced as if such illegal, invalid or unenforceable provision had never comprised a part hereof, (iii) the remaining provisions of this Transition Agreement shall remain in full force and effect and shall not be affected by the illegal, invalid or unenforceable provision or by its severance herefrom and (iv) in lieu of such illegal, invalid or unenforceable provision, there shall be added automatically as a part of this Transition Agreement a legal, valid and enforceable provision as similar in terms to such illegal, invalid, or unenforceable provision as may be possible and reasonably acceptable to the Parties. To the fullest extent permitted by Applicable Law, each Party hereby waives any provision of law that would render any provision hereof illegal, invalid, or unenforceable in any respect.", "": "" }, { "Text": "11.2 Assignment, Without the prior written consent of the other Party, neither Party shall sell, transfer, assign, delegate, pledge, or otherwise dispose of, whether voluntarily, involuntarily, by operation of law or otherwise, this Transition Agreement or any of its rights or duties hereunder; provided that either Party may make such an assignment in whole or in part without the other Party's consent to its Affiliate or to a successor, whether in a merger, sale of stock, sale of assets or any other transaction, of the busincss to which this Transition Agreement relates. With respect to an assignment to an Affiliate, the assigning Party shall remain responsible for the performance by such Affiliate of the rights and obligations hereunder. Any attempted assignment or delegation in violation of this Section 411.2 shall be void and of no effect. All validly assigned and delegated rights and obligations of the Parties hereunder shall be binding upon and inure to the benefit of and be enforceable by and against the successors and permitted assigns of BioArctic or AbbVie, as the case may be. The permitted assignee or transferee shall assume all obligations of its assignor or transferor under this Transition Agreement, Without limiting the foregoing, the grant of rights set forth in this Transition Agreement shall be binding upon any successor or permitted assignee of AbbVie, and the obligations of BioArctic, including the payment obligations, shall run in favor of any such successor or permitted assignee of AbbVic's benefits under this Transition Agreement.", "": "" }, { "Text": "11.3 Further Assurance. Each Party shall duly execute and deliver, or cause to be duly executed and delivered, such further instruments and do and cause to be done such further acts and things, including the filing of such assignments, agreements, documents and instruments, as may be necessary or as the other Party may reasonably request in connection with this Transition Agreement or to carry out more effectively the provisions and purposes hereof, or to better assure and confirm unto such other Party its rights and remedies under this Transition Agreement.", "": "" }, { "Text": "11.4 Governing Law. This Transition Agreement or the performance, enforcement, breach or termination hereof shall be interpreted, governed by and construed in accordance with the laws of the State of Delaware, United States, excluding any conflicts or choice of law rule or principle that might otherwise refer construction or interpretation of this Transition Agreement to the substantive law of another jurisdiction; provided that the construction or effect of Patents shall be determined in accordance with the laws of the country or other jurisdiction in which the particular Patent has been filed or granted, as the case may be. The Parties agree to exclude the application to this Transition Agreement of the United Nations Convention on Contracts for the International Sale of Goods.", "": "" }, { "Text": "14.5 Dispute Resolution, Any dispute arising out of, or in connection with, this Transition Agreement shall be settled by alternative dispute resolution pursuant to the terms set forth in Section 13.8 of the Collaboration Agreement.", "": "" }, { "Text": "11.6 References. Unless otherwise specified, (i) references in this Transition Agreement to any Section or Schedule shall mean references to such Section or Schedule of this Transition Agreement, (ii) references in any Scction to any clause are references to such clause of such Section and (iii) references to any agreement, instrument or other document in this Transition Agreement refer to such agreement, instrument or other document as originally executed or, if subsequently amended, replaced or supplemented from time lo lime, as so amended, replaced, or supplemented and in effect at the relevant time of reference thereto.", "": "" }, { "Text": "11.7. Entire Agreement; Amendments. This Transition Agreement, together with the Schedules attached hereto, sets forth and constitutes the entire agreement and understanding between the Parties with respect to the subject malter hereof and all prior agreements, understandings, promises, and representations, whether written or oral, with respect thereto are superseded hereby. Each Party confirms that it is not relying on any representations or warrantics of the other Party except as specifically set forth in this Transition Agreement. No amendment, modification, release, or discharge will be binding upon the Parties unless in writing and duly executed by authorized representatives of both Parties.", "": "" }, { "Text": "11.8 English Language; Construction: Rules of Interpretation. This Transition Agreement shail be written and executed in, and all other communications under or in connection with this Transition Agreement shall be in, the English language. Any translation into any other language shall not be an official version thereof, and in the event of any conflict in interpretation between the English version and such translation, the English version shall control. Except where the context otherwise requires, wherever used, the singular shall include the plural, the plural the singular, the use of any gender shall be applicable to all genders and the word \"or\" is used in the inclusive sense (and/or). Whenever this Transition Agreement refers to a number of days, unless otherwise specified, such number refers to calendar days. The headings of this Transition Agreement are for convenience of reference only and in no way define, describe, extend, or limit the scope or intent of this Transition Agreement or the intent of any provision contained in this Transition Agreement, The term \"including,\" \"include,\" or \"includes\" as used herein shall mean \"including, but not limited ta,\" and shall not limit the generality of any description preceding such term. The language of this Transition Agreement shall be deemed to be the language mutually chosen by the Parties and no rule of strict construction shall be applied against either Party hereto. Each Party represents that it has been represented by legal counsel in connection with this Transition Agreement and acknowledges that it has participated in the drafting hereof. In interpreting and applying the terms and provisions of this Transition Agreement, the Parties agree that no presumption will apply against the Party which drafted such terms and provisions,", "": "" }, { "Text": "11.9 Counterparts. This Transition Agreement may be executed via electronic transmission in any number of counterparts and by each Party in separate counterparts, each of which shall be deemed to constitute an original, and all of which shall be deemed to constitute one and the same instrument and may be altered or amended only in writing and if duly signed by both Parties.", "": "" }, { "Text": "[Signature Pages Follow]", "": "" }, { "Text": "IN WITNESS WHEREOF, the duly nominated representatives of each of the Parties hereto have executed this Transition Agreement as of the Transition Effective Date.", "": "" }, { "Text": "ABBVIE GLOBAL ENTERPRISES LTD.", "": "" }, { "Text": "be By: Arthur C. Price (Aug 8, 2022 15:22 ADT) Arthur C. Price Name: Title: Director", "": "" }, { "Text": "BIQARCTIC AB (publ ) . BX Sh EE. ' X \\ Name. EUgeN Steiner /vo ; Ver er Board member . Title: Depurh L Ie 17 tAC", "": "" }, { "Text": "Schedule 4.3 Transferred Regulatory Documentation e FDA correspondence and meeting minutes ¢ PMDA correspondence and mecting minutes ¢ EMA correspondence and meeting minutes « MAD withdrawal letter * M19-035 (phase 2) study protocol © Type C meeting documentation « EMA correspondence regarding phase 2 « IND 140404 e Fast Track submission e INN feedback ¢ = Clinical Study Documents o MI19-034 Database (eTMF) o MI19-465 Database (eTMF), including CSR o TMF Index File (V16.1)", "": "" }, { "Text": "Schedule 4.7 Pharmacokinetic and Toxicology Information * alpha-synuclein RT-QuiC assay protocol e Information summary for M19-035 Ph2 dose selection * NCA analysis of M19-034 and M19-465 reports e 4-week GLP SC Injection Toxicity and Toxicokinetic Study Report in Cynomolgus Monkeys * Non-GLP IV DRF Study Report on Embryo-Fetal Development in Rabbits", "": "" }, { "Text": "Schedule 4.8 Inventory & Supporting Documentation * Cell lines expressing anti-idiotypic antibodies directed to ABBV-0805 e Anti-idiotypic antibodies directed to ABBV-0805 and any existing labeled forms * Plasmids used to make anti-idiatypie antibodies directed to ABBV-0805 ¢ Licensed Compound (ABBV-0805 clinical material) © Drug product: o 45 trays with 7141 vials total o Dimensions of one tray (container) with 159 vials are as follows: o 38cm length x 24 cm wide x 5 em height * Drug substance & samples (~6.6 kg protein for GMP): o 4 liter bottles with a dimension of 33 cm height x 15 em wide (26 bottles) - GMP o", "": "" }, { "Text": "AbbVie Ireland NL B.V.
Zuiderzeelaan 53
Zwolle 8017 JV
Netherlands
abbvie.com", "": "" }, { "Text": "21-Apr-22", "": "" }, { "Text": "Dragonfly Therapeutics, Inc.
35 Gatehouse Dr.
Waltham, MA 02451", "": "" }, { "Text": "Re: Materials supplied for use pursuant to the Research Collaboration and Option Agreement between Dragonfly Therapeutics, Inc. and AbbVie Ireland NL BV, dated as of November 19, 2019", "": "" }, { "Text": "Dear Brian Fairchild:", "": "" }, { "Text": "This letter sets out the agreements between AbbVie and Dragonfly Therapeutics, Inc. Dragonfly to the provision of certain materials.", "": "" }, { "Text": "AbbVie agrees to receive from Dragonfly quantities of 719-muIgG2a, 719-muIgG2a-F0, 719-muIgG2a-F4, 514-muIgG2a, 514-muIgG2a-F0, 514-muIgG2a-F4, Pali-muIgG2a-F0 and Pali-muIgG2a-F4 Compounds use as described in Exhibit A attached to this letter Study in the support of activities pursuant to the Research Plan for the Collaboration Target DC-SIGN.", "": "" }, { "Text": "AbbVie agrees to use the Provided Compound only for the performance of the Study under the terms of this letter and the Agreement. Provided Compound is not to be used in humans, nor shall any of the Provided Compound, or any derivatives, analogs, modifications or components thereof be transferred, delivered or disclosed to any Third Party without the prior written approval of Dragonfly. Any unused Provided Compound and any derivatives, analogs, modifications or components thereof shall be, at Dragonfly Dragonfly, or destroyed in accordance with instructions by Dragonfly. For purposes of clarity, AbbVie receives no right, title or interest in such Provided Compound (including any Dragonfly Platform IP contained therein) other than as expressly set forth herein.", "": "" }, { "Text": "Capitalized terms used in this letter but not defined herein have the meanings provided in the Agreement. The parties agree that disputes related to this letter will be governed by the provisions of Section 10.7 of the Agreement.", "": "" }, { "Text": "If Dragonfly agrees to the terms and conditions set forth in this letter, please return a countersigned copy to AbbVie. If you have any questions regarding this letter, please contact Amanda McAlister (Amanda.mcallister@abbvie.com ).", "": "" }, { "Text": "Sincerely,", "": "" }, { "Text": "AbbVie Ireland NL BV
By:Calum Park-Director", "": "" }, { "Text": "Agreed:

DRAGONFLY THERAPEUTICS, INC.
By: [signature]
Name: Brian Fairchild
Title: SVP, Legal", "": "" }, { "Text": "EXHIBIT A

Study", "": "" }, { "Text": "In vitro/Ex vivo characterization studies
Binding to Tg huDC-SIGN+ cells
Activation of murine NK cells in co-culture with Tg huDC-SIGN+ cells
Killing assays with murine NK cells co-cultured with Tg huDC-SIGN+ cells
TriNKET treated DC mediated Treg production", "": "" }, { "Text": "In vivo PK study
Serum stability, aggregation, LBA assays (includes assay development)
4 week Single dose PK study", "": "" }, { "Text": "In vivo study/studies to assess depletion of Tg huDC-SIGN+ cells
In-vivo killing assay
In-vivo Tcell profiling", "": "" }, { "Text": "In vivo study/studies to assess TriNKET efficacy in an autoimmune colitis disease model using Tg huDC-SIGN mice", "": "" }, { "Text": "BIOARCTIC", "": "" }, { "Text": "Stockholm, 6\" of May, 2022", "": "" }, { "Text": "AbbVie Global Enterprises Ltd. c/o Codan Services Limited Clarendon House 2 Church Street Hamilton HM11 Bermuda", "": "" }, { "Text": "Dear Sirs,", "": "" }, { "Text": "Consent to disclosure of Confidential Information and furtherance of Development work", "": "" }, { "Text": "Referring to the Research, Development, Option and License Agreement between BioArctic and AbbVie dated as of September 15, 2016 (the \"Agreement').", "": "" }, { "Text": "AbbVie has on 20 April, 2022 (the \"Notice Date\") served BioArctic notice of its termination of the Agreement, which in accordance with the terms of the Agreement will terminate on 19 July, 2022 (the \"Termination Date\").", "": "" }, { "Text": "As a consequence of AbbVie's termination of the Agreement, BioArctic desires to (i) immediately initiate discussions and negotiations with potential business parties to find one or more alternative licensees for (w) the compound known as BANO805, a humanized monoclonal antibody targeting a-synuclein protofibrils that has the amino acid sequence set forth on Schedule 1.98 of the Agreement, (x) any antibody targeting a-synuclein discovered or Developed in connection with the performance of the Initial Development Activities, (y) any antibody targeting a-synuclein discovered or Developed by BioArctic or its Affiliates as a backup to BANQ805, including those murine antibodies set forth on schedule 1.98 of the Agreement, and (z) products containing the foregoing ((w)-(y)), ((w)-(z) collectively, \"O805\"); and (ii) start work related to research, pre-clinical and other non-clinical testing, test method development and stability testing, toxicology, formulation, statistical analysis and report writing using 0805 (the \"Research Activities\") ((i) and (ii) collectively, the \"Purpose\").", "": "" }, { "Text": "It may be necessary for BioArctic to disclose certain Confidential Information that is solely and directly related to 0805 (the \"0805 Summary\") to existing or prospective collaboration partners, licensees, sublicensees, or other Third Parties in connection with the Purpose. Additionally, BioArctic must perform the Research Activities in respect of which AbbVie currently has the benefit of exclusivity under the Agreement.", "": "" }, { "Text": "Therefore AbbVie consents to BioArctic, during a period from the Notice Date until revocation of such consent by AbbVie in writing (such revocation not to occur before the Termination Date):", "": "" }, { "Text": "(a) disclosing the 0805 Summary to Third Parties; provided that (i) such disclosures are made only for the Purpose, and (ii) such Third Parties are held to written confidentiality obligations substantially similar to those set forth in the Agreement; and", "": "" }, { "Text": "(b) performing Research Activities, at its own cost and expense, either itself or through contractors; provided such contractors are held to written confidentiality obligations substantially similar to those set forth in the Agreement.", "": "" }, { "Text": "Notwithstanding anything contrary in this letter, AbbVie shall have no obligation to provide any assistance or supply any information to BioArctic in carrying out the Purpose of this letter agreement.", "": "" }, { "Text": "All Information and inventions that arise from the Research Activities will be treated in accordance with Section 7.1.1 of the Agreement.", "": "" }, { "Text": "Except as explicitly set forth above, nothing in this letter amends or modifies the Agreement. Capitalized terms not defined herein shall have the meaning defined in the Agreement.", "": "" }, { "Text": "This letter agreement may be executed in any number of counterparts (including pdf counterparts), each of which shall be deemed an original and all of which taken together shall be deemed to constitute one and the same instrument.", "": "" }, { "Text": "This letter is not intended to constitute a binding expression of the mutual intent of the Parties regarding the Transition Agreement. It is understood and agreed that a definitive Transition Agreement will contain other terms and conditions which will have been negotiated and finalized that will supersede the terms of this letter. Please confirm your agreement to the terms of this letter by signing below.", "": "" }, { "Text": "For and on behalf of BioArctic AB (publ)", "": "" }, { "Text": "Gunilla Osswald, CEO", "": "" }, { "Text": "Acknowledged and accepted for and on behalf of AbbVie Global Enterprises Ltd. (successor in interest to AbbVie Ireland Unlimited Company)", "": "" }, { "Text": "Electronically Signed: Arthur C. Price", "": "" }, { "Text": "Name: Arthur C. Price", "": "" }, { "Text": "Title. Director", "": "" }, { "Text": "AbbVie Global Enterprises Ltd. (Bermuda) — BioArtic Side Letter Final Audit Report 2022-05-06", "": "" }, { "Text": "Created: 2022-05-06 By: Li Ling Ong (li.ong@abbvie.com ) Status: Signed Transaction ID: CBJCHBCAABAAZ-yHn6Ur_HotyWxx78VtwiF UWqWRigzw", "": "" }, { "Text": "AbbVie Global Enterprises Ltd. (Bermuda) — BioArtic Side Letter \" History", "": "" }, { "Text": "Document created by Li Ling Ong (li.ong@abbvie.com ) 2022-05-06 - 3:28:04 PM GMT- IP address: 159.180.140.142", "": "" }, { "Text": "Document emailed to Arthur C. Price (pellp@bedfordmgt.bm ) for signature 2022-05-06 - 3:29:50 PM GMT", "": "" }, { "Text": "Email viewed by Arthur C. Price (pellp@bedfordmgt.bm ) 2022-05-06 - 5:19:33 PM GMT", "": "" }, { "Text": "Arthur C. Price (pellp@bedfordmgt.bm ) verified identity with Adobe Acrobat Sign authentication 2022-05-06 - 5:24:29 PM GMT", "": "" }, { "Text": "Document e-signed by Arthur C. Price (pellp@bedfordmgt.bm ) Signature Date: 2022-05-06 - 5:24:29 PM GMT - Time Source: server", "": "" }, { "Text": "Agreement completed. 2022-05-06 - 5:24:29 PM GMT", "": "" }, { "Text": "CO-DEVELOPMENT AND OPTION AGREEMENT between ALECTOR, INC. and ABBVIE BIOTECHNOLOGY, LTD. Dated as of October 16, 2017", "": "" }, { "Text": "This Co-Development and Option Agreement (this \"Agreement\") is made and entered into effective as of October 16, 2017 (the \"Execution Date\") by and between Alector, Inc. (f/k/a Alector LLC), a Delaware corporation (\"Licensor\"), and AbbVie Biotechnology, Ltd., a Bermuda limited company (\"AbbVie\"). Licensor and AbbVie are sometimes referred to herein individually as a \"Party\" and collectively as the \"Parties.", "": "" }, { "Text": "WHEREAS, Licensor has developed certain Licensed Antibodies (as defined herein) and Controls (as defined herein) certain intellectual property and other rights with respect to such Licensed Antibodies in the Territory (as defined herein); and", "": "" }, { "Text": "WHEREAS, Licensor wishes to grant an option to a license to AbbVie, and AbbVie wishes to take, such option to a license with respect to Licensed Antibodies under Licensor's intellectual property and other rights therein, for purposes of developing and commercializing Licensed Products (as defined herein) in the Territory, in each case in accordance with the terms and conditions set forth below.", "": "" }, { "Text": "NOW, THEREFORE, in consideration of the premises and the mutual promises and conditions hereinafter set forth, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, do hereby agree as follows:", "": "" }, { "Text": "ARTICLE 1. DEFINITIONS", "": "" }, { "Text": "1.1 \"AbbVie\" has the meaning set forth in the preamble hereto.", "": "" }, { "Text": "1.2 \"AbbVie Background Know-How\" means all Information that is (a) Controlled by AbbVie or any of its Affiliates on the Execution Date or at any time during the Term, (b) not generally known, (c) developed or invented outside the scope of this Agreement, and (d) either used by AbbVie or provided by AbbVie for use in the Development, Manufacture, or Commercialization of a Licensed Antibody or a Licensed Product.", "": "" }, { "Text": "1.3 \"AbbVie Background Patents\" means all Patents that are (a) Controlled by AbbVie or any of its Affiliates on the Execution Date or at any time during the Term, (b) developed or invented outside the scope of this Agreement, and (c) covering subject matter either used by AbbVie or provided by AbbVie for use in the Development, Manufacture, or Commercialization of a Licensed Antibody or a Licensed Product.", "": "" }, { "Text": "1.4 \"AbbVie Competing Product\" has the meaning set forth in Section 5.10.2(a).", "": "" }, { "Text": "1.5 \"AbbVie Grantback Know-How\" means, as used in connection with any grant back license provided in Section 12.8.1(c), AbbVie Program Know-How and Joint Program Know-How that (a) is Controlled by AbbVie as of the effective date of the applicable termination of this Agreement (either in its entirety or with respect to a Collaboration Program) or the grant of a license under Section 12.8.1(c), (b) is not generally known and (c) was used by either Party in the Development or Commercialization of a Licensed Product or Licensed Antibody as of or prior to the date of such termination, where the Licensed Product or Licensed Antibody is subject to such termination.", "": "" }, { "Text": "1.6 \"AbbVie Grantback Patents\" means, as used in connection with any grant back license provided in Section 12.8.1(c), AbbVie Program Patents and Joint Program Patents that (a) are Controlled by AbbVie as of the effective date of the applicable termination of this Agreement (either in its entirety or with respect to a Collaboration Program or the grant of a license under Section 12.8.1(c), and (b) claim a Licensed Product or Licensed Antibody or the use thereof, where the Licensed Product or Licensed Antibody is subject to such termination.", "": "" }, { "Text": "1.7 \"AbbVie Incorporated Background Know-How\" has the meaning set forth in Section 12.8.1(d).", "": "" }, { "Text": "1.8 \"AbbVie Indemnitees\" has the meaning set forth in Section 11.2.", "": "" }, { "Text": "1.9 \"AbbVie Independent New Technology\" means New Technology which AbbVie or its Affiliates has either acquired from a Third Party or developed outside the Collaboration Program without use or reference to the Confidential Information of Licensor, and which the Parties agree in writing will be applied to a Licensed Product as part of the Development Program (which writing specifically references this Section 1.9).", "": "" }, { "Text": "EXECUTION VERSION", "": "" }, { "Text": "COLLABORATION AND OPTION AGREEMENT", "": "" }, { "Text": "by and between", "": "" }, { "Text": "ANIMA BIOTECH INC.", "": "" }, { "Text": "AND", "": "" }, { "Text": "ABBVIE GLOBAL ENTERPRISES LTD.", "": "" }, { "Text": "TABLE OF CONTENTS", "": "" }, { "Text": "Page", "": "" }, { "Text": "ARTICLE 1 DEFINITIONS ......................................................................................................................... 1", "": "" }, { "Text": "ARTICLE 2 DEVELOPMENT; LICENSE OPTION ................................................................................ 20", "": "" }, { "Text": "2.1 Overview .............................................................................................................................. 20", "": "" }, { "Text": "2.2 Target Program Slots............................................................................................................ 20", "": "" }, { "Text": "2.3 Collaboration Target Substitution ........................................................................................ 20", "": "" }, { "Text": "2.4 Gatekeeper ........................................................................................................................... 21", "": "" }, { "Text": "2.5 Selection of Available Targets ............................................................................................. 21", "": "" }, { "Text": "2.6 Collaboration Plans .............................................................................................................. 22", "": "" }, { "Text": "2.7 Conduct of Collaboration Activities .................................................................................... 22", "": "" }, { "Text": "2.8 IP Assignment Obligation .................................................................................................... 24", "": "" }, { "Text": "2.9 License Option ..................................................................................................................... 24", "": "" }, { "Text": "2.10 Conduct of Post-License Option Exercise Activities ........................................................... 25", "": "" }, { "Text": "2.11 HSR. ..................................................................................................................................... 25", "": "" }, { "Text": "2.12 No Exercise of License Option ............................................................................................ 26", "": "" }, { "Text": "ARTICLE 3 MANAGEMENT OF THE COLLABORATION ................................................................. 26", "": "" }, { "Text": "3.1 Joint Governance Committee ............................................................................................... 26", "": "" }, { "Text": "3.2 Responsibilities .................................................................................................................... 27", "": "" }, { "Text": "3.3 Meetings and Minutes .......................................................................................................... 27", "": "" }, { "Text": "3.4 Procedural Rules .................................................................................................................. 28", "": "" }, { "Text": "3.5 Decision-Making .................................................................................................................. 28", "": "" }, { "Text": "3.6 Limits on Decision-Making ................................................................................................. 29", "": "" }, { "Text": "3.7 Alliance Managers ............................................................................................................... 29", "": "" }, { "Text": "3.8 Discontinuation of Committees ............................................................................................ 29", "": "" }, { "Text": "3.9 Interactions Between a Committee and Internal Teams ....................................................... 30", "": "" }, { "Text": "3.10 Subcommittees ..................................................................................................................... 30", "": "" }, { "Text": "3.11 Expenses ............................................................................................................................... 30", "": "" }, { "Text": "3.12 Authority .............................................................................................................................. 30", "": "" }, { "Text": "ARTICLE 4 GRANT OF LICENSES ........................................................................................................ 30", "": "" }, { "Text": "4.1 Licenses to AbbVie .............................................................................................................. 30", "": "" }, { "Text": "4.2 Sublicensing Rights .............................................................................................................. 31", "": "" }, { "Text": "4.3 UPenn Rights ....................................................................................................................... 31", "": "" }, { "Text": "4.4 No Other Rights ................................................................................................................... 32", "": "" }, { "Text": "4.5 Confirmatory Patent License ................................................................................................ 32", "": "" }, { "Text": "4.6 In-License Agreements ........................................................................................................ 32", "": "" }, { "Text": "4.7 Rights in Bankruptcy............................................................................................................ 32", "": "" }, { "Text": "ARTICLE 5 POST-LICENSE OPTION EXERCISE ACTIVITIES .......................................................... 33", "": "" }, { "Text": "5.1 Anima Transition Obligation Upon License Option Exercise ............................................. 33", "": "" }, { "Text": "5.2 AbbVie Development and Commercialization .................................................................... 33", "": "" }, { "Text": "5.3 AbbVie Diligence Obligation .............................................................................................. 33", "": "" }, { "Text": "ARTICLE 6 GENERAL PROVISIONS RELATING TO ACTIVITIES .................................................. 34", "": "" }, { "Text": "6.1 Compliance .......................................................................................................................... 34", "": "" }, { "Text": "6.2 Regulatory Activities ........................................................................................................... 34", "": "" }, { "Text": "6.3 Performance by Affiliates and Sublicensees ........................................................................ 34", "": "" }, { "Text": "6.4 Subcontracting ..................................................................................................................... 34", "": "" }, { "Text": "6.5 Records and Audits .............................................................................................................. 35", "": "" }, { "Text": "ARTICLE 7 UPFRONT FEE; MILESTONES AND ROYALTIES; PAYMENTS .................................. 35", "": "" }, { "Text": "7.1 Upfront Fee .......................................................................................................................... 35", "": "" }, { "Text": "7.2 Additional Target Program Fee ............................................................................................ 35", "": "" }, { "Text": "7.3 Collaboration Target Substitution Fee ................................................................................. 35", "": "" }, { "Text": "7.4 License Option Period Extension Fee .................................................................................. 37", "": "" }, { "Text": "7.5 License Option Exercise Fee ................................................................................................ 38", "": "" }, { "Text": "7.6 Development and Regulatory Milestone Payments ............................................................. 38", "": "" }, { "Text": "7.7 Sales-Based Milestone Payments ......................................................................................... 40", "": "" }, { "Text": "7.8 Royalties ............................................................................................................................... 41", "": "" }, { "Text": "7.9 Royalty Term ....................................................................................................................... 42", "": "" }, { "Text": "7.10 Royalty and Milestone Adjustments .................................................................................... 42", "": "" }, { "Text": "7.11 Estimated Sales Levels ......................................................................................................... 43", "": "" }, { "Text": "7.12 Reports; Payment of Royalty ............................................................................................... 44", "": "" }, { "Text": "7.13 Financial Records ................................................................................................................. 44", "": "" }, { "Text": "7.14 Audit; Audit Dispute. ........................................................................................................... 44", "": "" }, { "Text": "7.15 Methods of Payments; Offsets ............................................................................................. 44", "": "" }, { "Text": "7.16 Taxes .................................................................................................................................... 45", "": "" }, { "Text": "7.17 Late Payments ...................................................................................................................... 46", "": "" }, { "Text": "7.18 Financial Obligations under In-License Agreements ........................................................... 46", "": "" }, { "Text": "ARTICLE 8 EXCLUSIVITY; CHANGE OF CONTROL ......................................................................... 46", "": "" }, { "Text": "8.1 Exclusivity ........................................................................................................................... 46", "": "" }, { "Text": "8.2 Change of Control of Anima ................................................................................................ 51", "": "" }, { "Text": "ARTICLE 9 INTELLECTUAL PROPERTY RIGHTS ............................................................................. 52", "": "" }, { "Text": "9.1 Ownership of Intellectual Property; Disclosure ................................................................... 52", "": "" }, { "Text": "9.2 AbbVie Patents .................................................................................................................... 52", "": "" }, { "Text": "9.3 Patent Prosecution and Maintenance ................................................................................... 53", "": "" }, { "Text": "9.4 Enforcement of Licensed IP ................................................................................................. 54", "": "" }, { "Text": "9.5 Infringement Claims by Third Parties .................................................................................. 54", "": "" }, { "Text": "9.6 Invalidity or Unenforceability Defenses or Actions ............................................................ 55", "": "" }, { "Text": "9.7 Third Party Licenses ............................................................................................................ 55", "": "" }, { "Text": "9.8 Product Trademarks ............................................................................................................. 56", "": "" }, { "Text": "9.9 Inventor's Remuneration ...................................................................................................... 56", "": "" }, { "Text": "9.10 International Nonproprietary Name ..................................................................................... 56", "": "" }, { "Text": "ARTICLE 10 CONFIDENTIALITY .......................................................................................................... 56", "": "" }, { "Text": "10.1 Product Information ............................................................................................................. 56", "": "" }, { "Text": "10.2 Confidentiality Obligations .................................................................................................. 57", "": "" }, { "Text": "10.3 Permitted Disclosures........................................................................................................... 58", "": "" }, { "Text": "10.4 Use of Name ......................................................................................................................... 59", "": "" }, { "Text": "10.5 Public Announcements......................................................................................................... 59", "": "" }, { "Text": "10.6 Publications .......................................................................................................................... 60", "": "" }, { "Text": "10.7 Return of Confidential Information ..................................................................................... 60", "": "" }, { "Text": "10.8 Survival ................................................................................................................................ 60", "": "" }, { "Text": "ARTICLE 11 REPRESENTATIONS AND WARRANTIES .................................................................... 60", "": "" }, { "Text": "11.1 Representations and Warranties of Both Parties .................................................................. 60", "": "" }, { "Text": "11.2 Representations, Warranties, and Covenants, as applicable, of Anima ............................... 61", "": "" }, { "Text": "11.3 Compliance with Applicable Law ........................................................................................ 66", "": "" }, { "Text": "11.4 Additional Covenants of Anima ........................................................................................... 66", "": "" }, { "Text": "11.5 Anti-Bribery and Anti-Corruption Compliance ................................................................... 66", "": "" }, { "Text": "11.6 Disclaimer ............................................................................................................................ 66", "": "" }, { "Text": "ARTICLE 12 INDEMNIFICATION; INSURANCE ................................................................................. 66", "": "" }, { "Text": "12.1 Indemnification by AbbVie .................................................................................................. 66", "": "" }, { "Text": "12.2 Indemnification by Anima ................................................................................................... 67", "": "" }, { "Text": "12.3 Procedure ............................................................................................................................. 68", "": "" }, { "Text": "12.4 Insurance .............................................................................................................................. 69", "": "" }, { "Text": "12.5 Limitation of Liability .......................................................................................................... 70", "": "" }, { "Text": "ARTICLE 13 TERM AND TERMINATION ............................................................................................ 70", "": "" }, { "Text": "13.1 Term ..................................................................................................................................... 70", "": "" }, { "Text": "13.2 Termination .......................................................................................................................... 71", "": "" }, { "Text": "13.3 Modification in Lieu of Termination ................................................................................... 72", "": "" }, { "Text": "13.4 Effects of Termination ......................................................................................................... 73", "": "" }, { "Text": "13.5 Effects of Termination in Terminated Territory .................................................................. 74", "": "" }, { "Text": "13.6 Accrued Rights; Surviving Provisions of the Agreement .................................................... 74", "": "" }, { "Text": "ARTICLE 14 MISCELLANEOUS ............................................................................................................ 75", "": "" }, { "Text": "14.1 Governing Law; Service ...................................................................................................... 75", "": "" }, { "Text": "14.2 Dispute Resolution ............................................................................................................... 75", "": "" }, { "Text": "14.3 Assignment ........................................................................................................................... 76", "": "" }, { "Text": "14.4 Force Majeure ...................................................................................................................... 77", "": "" }, { "Text": "14.5 Notices ................................................................................................................................. 77", "": "" }, { "Text": "14.6 Export Clause ....................................................................................................................... 78", "": "" }, { "Text": "14.7 Waiver; Non-Exclusion of Remedies ................................................................................... 78", "": "" }, { "Text": "14.8 Further Assurance ................................................................................................................ 78", "": "" }, { "Text": "14.9 Severability .......................................................................................................................... 78", "": "" }, { "Text": "14.10 Equitable Relief .................................................................................................................... 79", "": "" }, { "Text": "14.11 Entire Agreement; Amendments .......................................................................................... 79", "": "" }, { "Text": "14.12 Relationship of the Parties ................................................................................................... 79", "": "" }, { "Text": "14.13 Headings; Construction; Interpretation ................................................................................ 80", "": "" }, { "Text": "14.14 Books and Records ............................................................................................................... 80", "": "" }, { "Text": "14.15 English Language ................................................................................................................. 80", "": "" }, { "Text": "14.16 Parties in Interest .................................................................................................................. 80", "": "" }, { "Text": "14.17 Counterparts ......................................................................................................................... 80", "": "" }, { "Text": "EXHIBITS AND SCHEDULES", "": "" }, { "Text": "Exhibit A-1 Initial Collaboration Targets", "": "" }, { "Text": "Exhibit A-2 Reserved Targets", "": "" }, { "Text": "Exhibit B-1 Initial Collaboration Plan", "": "" }, { "Text": "Exhibit B-2 Cost of Activities for Collaboration Plans", "": "" }, { "Text": "Exhibit C-1 Success Criteria for Option Exercise Data Package Prior to Payment of License Option Period Extension Fee", "": "" }, { "Text": "Exhibit C-2 Success Criteria for Option Exercise Data Package Following Payment of License Option Period Extension Fee", "": "" }, { "Text": "Schedule 1.13 Existing Patents", "": "" }, { "Text": "Schedule 1.72 Existing In-License Agreements", "": "" }, { "Text": "Schedule 10.5 Public Announcement", "": "" }, { "Text": "Schedule 11.2 Anima Disclosure Schedule", "": "" }, { "Text": "Schedule 14.2.2 ADR Procedures", "": "" }, { "Text": "COLLABORATION AND OPTION AGREEMENT", "": "" }, { "Text": "This COLLABORATION AND OPTION AGREEMENT (this \"Agreement\") is entered into and made effective as of January 9, 2023 (the \"Effective Date\"), by and between Anima Biotech Inc., a Delaware corporation, having its principal place of business at 75 Claremont Road, Suite 102, Bernardsville, NJ 07924, USA (\"Anima\"), and AbbVie Global Enterprises Ltd., a Bermuda limited company, having its principal place of business at Thistle House, 4 Burnaby Street, Hamilton Pembroke HM 11, Bermuda (\"AbbVie\"). Anima and AbbVie shall be referred to herein individually as a \"Party\" and collectively as the \"Parties.", "": "" }, { "Text": "RECITALS", "": "" }, { "Text": "WHEREAS, Anima is a biotechnology company focused on the research and development of selective small molecule mRNA drugs and their mechanisms of action;", "": "" }, { "Text": "WHEREAS, AbbVie possesses expertise in the research, development, manufacturing, and commercialization of human pharmaceuticals; and", "": "" }, { "Text": "WHEREAS, Anima and AbbVie desire to engage in a collaborative effort pursuant to which Anima will carry out certain preclinical research activities set forth in each Collaboration Plan and pursuant to which AbbVie will have an option to develop and commercialize Royalty-Bearing Products worldwide, in each case as set forth in, and subject to the terms of, this Agreement.", "": "" }, { "Text": "NOW, THEREFORE, in consideration of the premises and mutual covenants herein contained, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:", "": "" }, { "Text": "ARTICLE 1 DEFINITIONS", "": "" }, { "Text": "As used in this Agreement, the following terms will have the meanings set forth in this ARTICLE 1 (Definitions) unless context dictates otherwise:", "": "" }, { "Text": "1.1 \"AbbVie Collaboration Activities License\" has the meaning set forth in Section 4.1.2 (Collaboration Activities License).", "": "" }, { "Text": "1.2 \"AbbVie License\" has the meaning set forth in Section 4.1.1 (Commercial License).", "": "" }, { "Text": "1.3 \"Accounting Standards\" means, with respect to a Party or its Affiliates or its or their (sub)licensees/Sublicensees, United States generally accepted accounting principles or International Financial Reporting Standards as issued by the International Accounting Standards Board, as applicable, in each case consistently applied.", "": "" }, { "Text": "1.4 \"ADC Inclusion Date\" has the meaning set forth in Section 2.7.5 (Anima Discovered Compounds).", "": "" }, { "Text": "1.5 \"Additional Target Program Fee\" has the meaning set forth in Section 7.2 (Additional Target Program Fee).", "": "" }, { "Text": "1.6 \"Additional Target Program Slot\" has the meaning set forth in Section 2.2.2 (Additional Target Program Slots).", "": "" }, { "Text": "1.7 \"Additional Target Program Slot Designation Date\" has the meaning set forth in Section 7.2 (Additional Target Program Fee).", "": "" }, { "Text": "1.8 \"ADR\" has the meaning set forth in Section 14.2.1 (General).", "": "" }, { "Text": "1.9 \"Adverse Ruling\" has the meaning set forth in Section 13.2.1(a) (Material Breach).", "": "" }, { "Text": "1.10 \"Affiliate\" means, with respect to a Person, any Person that, directly or indirectly through one (1) or more intermediaries, controls, is controlled by, or is under common control with such first Person for so long as such Person controls, is controlled by, or is under common control with such first Person, regardless of whether such Affiliate is or becomes an Affiliate on or after the Effective Date. A Person shall be deemed to \"control\" another Person if it (a) owns, directly or indirectly, beneficially or legally, more than fifty percent (50%) of the outstanding voting securities or capital stock of such other Person, or has other comparable ownership interests with respect to any Person other than a corporation; or (b) has the power, whether pursuant to contract, ownership of securities, or otherwise, to direct the management and policies of such other Person.", "": "" }, { "Text": "1.11 \"Anima Acquirer\" has the meaning set forth in Section 8.1.2 (Effect of Change of Control of Anima).", "": "" }, { "Text": "1.12 \"Anima Background Know-How\" means (a) all Know-How that is Anima Platform Technology and (b) all other Know-How other than Collaboration Know-How that is Controlled by Anima or any of its Affiliates as of the Effective Date or at any time during the Term and that, in each case ((a) and (b)) is: (i) not generally known and (ii) necessary or reasonably useful for (A) the conduct of activities allocated to either Party under any Collaboration Plan or Anima's conduct of any Post-License Option Exercise Activities, or (B) the use of any License Option Exercise Data Package (including any component thereof); but in each case ((a) and (b)) excluding: (y) any such Know-How disclosed by published Anima Background Patents and (z) any Know-How independently generated by or on behalf of Anima or its Affiliates alone or with a Third Party in activities unrelated to the Collaboration Targets and conducted without breaching Anima's exclusivity obligations in Section 8.1.1 (Anima Exclusivity Obligation). \"Anima Background Know-How\" excludes all UPenn Technology.", "": "" }, { "Text": "1.13 \"Anima Background Patents\" means all Patent Rights, other than Collaboration Patents, that (a) are Controlled by Anima or any of its Affiliates as of the Effective Date or at any time during the Term and (b) (i) are necessary or reasonably useful for the conduct of activities allocated to either Party under any Collaboration Plan or Anima's conduct of any Post-License Option Exercise Activities or (ii) claim any Anima Background Know-How. Anima Background Patents include all Patent Rights set forth on Schedule 1.13 (Existing Patents). \"Anima Background Patents\" excludes all UPenn Technology.", "": "" }, { "Text": "1.14 \"Anima Collaboration Patent\" means any Collaboration Patent that claims Collaboration Know-How that is conceived, reduced to practice, generated, discovered, developed, or otherwise made solely by or on behalf of Anima or its Affiliates, except to the extent such Collaboration Patent claims any Anima Improvement.", "": "" }, { "Text": "1.15 \"Anima Compound Library\" means the collection of compounds assembled by Anima or its Affiliates from commercially available sources to be used in the conduct of activities under a Collaboration Plan.", "": "" }, { "Text": "1.16 \"Anima Developed Compound\" or \"ADC\" means, with respect to a Collaboration Target, any compound that (a) was discovered, developed, designed, or synthesized by or on behalf of Anima or its Affiliates during the conduct of activities under a Collaboration Plan, and (b) is Directed To the applicable Collaboration Target.", "": "" }, { "Text": "1.17 \"Anima Improvement\" means: (a) all Know-How that: (i) constitutes an improvement to the Anima Platform Technology, Anima Background Patents, or Anima Background Know-How; (ii) is conceived, reduced to practice, generated, discovered, developed, or otherwise made solely by or on behalf of Anima in the conduct of activities under any Collaboration Plan; (iii) does not include any Confidential Information of AbbVie; and (iv) does not directly or specifically relate to any License Option Exercise Data Package or to a Collaboration Target, provided that Know-How described in clauses (i) through (iii) will not be deemed to directly or specifically relate to a License Option Exercise Data Package or a Collaboration Target for purposes of this clause (iv) as a result of the fact that the Anima Platform Technology was used to generate the License Option Exercise Data Package or to discover compounds that bind to, inhibit, activate, or modulate the activity, translation, expression, or mRNA of a Collaboration Target; and (b) all Patent Rights that claim such Know-How described in the foregoing clause (a) (such Patent Rights, the \"Anima Improvement Patents\").", "": "" }, { "Text": "1.18 \"Anima Improvement Patents\" has the meaning set forth in Section 1.17 (\"Anima Improvement\").", "": "" }, { "Text": "1.19 \"Anima Platform Technology\" means Anima's proprietary platform and related Know-How for discovery of small molecule compounds that control mRNA or protein biology (including bioinformatics, screening technologies and assays, image analysis, activity and selectivity analysis, mechanism of action and target ID elucidation, and all related software).", "": "" }, { "Text": "1.20 \"Anima Severe Material Breach\" means, where AbbVie has the right to terminate this Agreement pursuant to Section 13.2.1 (Termination for Cause) for an uncured material breach by Anima of a material obligation, solely for the purpose of determining whether the modifications set forth in Sections 13.3.1 through 13.3.4 will apply with respect to all Collaboration Targets and Royalty-Bearing Products under this Agreement or solely with respect to the Collaboration Target(s) to which such material breach applies, an uncured material breach by Anima that relates to Section 2.7.5 (Anima Discovered Compounds); Section 2.8 (IP Assignment Obligation); Section 2.9.1 (Grant of License Option); ARTICLE 4 (Grant of Licenses); Section 6.1 (Compliance); ARTICLE 8 (Exclusivity; Change of Control); Section 9.1.4 (Control of Intellectual Property); ARTICLE 10 (Confidentiality); Section 11.1 (Representations and Warranties of Both Parties); Sections 11.2.2, 11.2.3, 11.2.4, 11.2.6, 11.2.8, 11.2.10, 11.2.19, 11.2.20, 11.2.26, 11.2.27, 11.2.28, 11.2.30, and 11.2.32 (Representations, Warranties, and Covenants, as applicable, of Anima); any representation, warranty, or covenant in this Agreement related to the UPenn Agreement or the Ramot Agreement; Section 11.3 (Compliance with Applicable Law); Section 11.4 (Additional Covenants of Anima); Section 11.5 (Anti-Bribery and Anti-Corruption Compliance); and Section 14.3 (Assignment).", "": "" }, { "Text": "1.21 \"Annual Net Sales\" means, with respect to a Royalty-Bearing Product, the total Net Sales of such Royalty-Bearing Product in the Territory in a particular Calendar Year.", "": "" }, { "Text": "1.22 \"Annual Net Sales Milestone Threshold\" has the meaning set forth in Section 7.7 (Sales-Based Milestone Payments).", "": "" }, { "Text": "1.23 \"Annual Net Sales-Based Milestone Payment\" has the meaning set forth in Section 7.7 (Sales-Based Milestone Payments).", "": "" }, { "Text": "1.24 \"Annual Net Sales-Based Milestone Table\" has the meaning set forth in Section 7.7 (Sales-Based Milestone Payments).", "": "" }, { "Text": "1.25 \"Audit Arbitrator\" has the meaning set forth in Section 7.14.2 (Audit Dispute).", "": "" }, { "Text": "1.26 \"Available Target\" means any target, other than a Collaboration Target, that is (a) a Reserved Target or (b) otherwise deemed to be an Available Target under Section 2.5 (Selection of Available Targets).", "": "" }, { "Text": "1.27 \"Bankruptcy Code Intellectual Property\" has the meaning set forth in Section 4.7.1 (Section 365(n) of the Bankruptcy Code).", "": "" }, { "Text": "1.28 \"Board of Directors\" has the meaning set forth in Section 1.34.1 (\"Change of Control\").", "": "" }, { "Text": "1.29 \"Breaching Party\" has the meaning set forth in Section 13.2.1(a) (Material Breach).", "": "" }, { "Text": "1.30 \"Business Day\" means a day other than a Saturday or Sunday on which banking institutions in Chicago, Illinois are open for business.", "": "" }, { "Text": "1.31 \"Calendar Quarter\" means a period of three (3) consecutive months ending on the last day of March, June, September, or December, respectively, except that the first Calendar Quarter of the Term shall commence on the Effective Date and end on the day immediately prior to the first to occur of January 1, April 1, July 1, or October 1 after the Effective Date and the last Calendar Quarter shall end on the last day of the Term.", "": "" }, { "Text": "1.32 \"Calendar Year\" means a period of twelve (12) consecutive months beginning on January 1 and ending on December 31, except that the first Calendar Year of the Term shall commence on the Effective Date and end on December 31 of the year in which the Effective Date occurs and the last Calendar Year of the Term shall commence on January 1 of the year in which the Term ends and end on the last day of the Term.", "": "" }, { "Text": "1.33 \"CDA\" has the meaning set forth in Section 14.11 (Entire Agreement; Amendments).", "": "" }, { "Text": "1.34 \"Change of Control\" with respect to a Party, shall be deemed to have occurred if any of the following occurs after the Effective Date:", "": "" }, { "Text": "1.34.1 any \"person\" or \"group\" (as such terms are defined below): (a) is or becomes the \"beneficial owner\" (as defined below), directly or indirectly, of shares of capital stock or other interests (including partnership interests) of such Party then outstanding and normally entitled (without regard to the occurrence of any contingency) to vote in the election of the directors, managers, or similar supervisory positions (\"Voting Stock\") of such Party representing fifty percent (50%) or more of the total voting power of all outstanding classes of Voting Stock of such Party; or (b) has the power, directly or indirectly, to elect a majority of the members of the Party's board of directors, or similar governing body (\"Board of Directors\"); the Parties acknowledge that in the case of certain entities organized under the laws of certain countries outside of the United States, the maximum percentage ownership permitted by law for a foreign investor may be less than fifty percent (50%), and that in such case such lower percentage shall be substituted in the preceding sentence, provided that such foreign investor has the power to direct the management or policies of such entity; or", "": "" }, { "Text": "1.34.2 such Party enters into a merger, consolidation, or similar transaction with another Person (whether or not such Party is the surviving entity) and as a result of such merger, consolidation, or similar transaction: (a) the members of the Board of Directors of such Party immediately prior to such transaction constitute less than a majority of the members of the Board of Directors of such Party or such surviving Person immediately following such transaction; or (b) the Persons that beneficially owned, directly or indirectly, the shares of Voting Stock of such Party immediately prior to such transaction cease to beneficially own, directly or indirectly, shares of Voting Stock of such Party representing at least a majority of the total voting power of all outstanding classes of Voting Stock of the surviving Person in substantially the same proportions as their ownership of Voting Stock of such Party immediately prior to such transaction; or", "": "" }, { "Text": "1.34.3 the holders of capital stock of such Party approve a plan or proposal for the liquidation or dissolution of such Party.", "": "" }, { "Text": "For the purpose of this definition of Change of Control: (a) \"person\" and \"group\" have the meanings given such terms under Section 13(d) and 14(d) of the United States Securities Exchange Act of 1934 and the term \"group\" includes any group acting for the purpose of acquiring, holding, or disposing of securities within the meaning of Rule 13d-5(b)(1) under the said Act; (b) a \"beneficial owner\" shall be determined in accordance with Rule 13d-3 under the aforesaid Act; and (c) the terms \"beneficially owned\" and \"beneficially own\" shall have meanings correlative to that of \"beneficial owner.", "": "" }, { "Text": "1.35 \"Clinical Data\" means all information with respect to any Royalty-Bearing Compound or Royalty-Bearing Product, which information is made, collected, or otherwise generated under or in connection with Clinical Trials (including Phase 4 Clinical Trials), including any data (including raw data), reports, and results with respect thereto.", "": "" }, { "Text": "1.36 \"Clinical Trial\" means a Phase 1 Clinical Trial, Phase 2 Clinical Trial, Phase 3 Clinical Trial, Phase 4 Clinical Trial, Registrational Clinical Trial, or any other study in which human subjects or patients are dosed with a drug, whether approved or investigational.", "": "" }, { "Text": "1.37 \"Collaboration Know-How\" means all information (including regulatory data, files, approvals, and other documentation) and other Know-How that is not generally known and is conceived, reduced to practice, generated, discovered, developed, or otherwise made (a) solely or jointly by or on behalf of either Party or its Affiliates in the conduct of activities under a Collaboration Plan or (b) by or on behalf of Anima or its Affiliates in the conduct of Post-License Option Exercise Activities, including each License Option Exercise Data Package and all contents thereof. Collaboration Know-How excludes Anima Improvements.", "": "" }, { "Text": "1.38 \"Collaboration Patent\" means any Patent Right that claims Collaboration Know-How.", "": "" }, { "Text": "1.39 \"Collaboration Plan\" means, with respect to any Target Program Slot, a research and development plan for such Target Program Slot that (a) is approved by the JGC in accordance with the terms of this Agreement and (b) includes at least those elements set forth in Exhibit B-1, as may be amended from time to time in accordance with the terms of this Agreement.", "": "" }, { "Text": "1.40 \"Collaboration Target\" means: (a) those \"Initial Collaboration Targets\" identified in Exhibit A-1 attached hereto; and (b) any other target that is designated a Collaboration Target in accordance with the terms of this Agreement.", "": "" }, { "Text": "1.41 \"Collaboration Target Substitution Fee\" has the meaning set forth in Section 7.3 (Collaboration Target Substitution Fee).", "": "" }, { "Text": "1.42 \"Collaboration Target Substitution Notice\" has the meaning set forth in Section 2.3 (Collaboration Target Substitution).", "": "" }, { "Text": "1.43 \"Collaboration Term\" means, with respect to each Target Program Slot, the period commencing on the Effective Date and ending upon: (a) if AbbVie does not exercise the License Option with respect to such Target Program Slot during the applicable License Option Period, the end date of such License Option Period; or (b) if AbbVie exercises the License Option with respect to such Target Program Slot during the applicable License Option Period, the earlier of (i) the date that the JGC determines will be the end date of such Collaboration Term or (ii) the date of the first IND acceptance of a Royalty-Bearing Product with respect to such Target Program Slot.", "": "" }, { "Text": "1.44 \"Combination Product\" means a Royalty-Bearing Product that contains a Royalty-Bearing Compound as an active ingredient, together with one (1) or more other active ingredients that are not Royalty-Bearing Compounds, and is sold either as a fixed dose/unit or as separate doses/units in a single package or for a single price.", "": "" }, { "Text": "1.45 \"Commercialization\" and \"Commercialize\" means any and all activities related to the preparation for sale of, offering for sale of, or sale of a Royalty-Bearing Compound or Royalty-Bearing Product, including activities related to marketing, promoting, distributing, importing, and exporting such Royalty-Bearing Compound or Royalty-Bearing Product, and, for purposes of setting forth the rights and obligations of the Parties under this Agreement, shall be deemed to include conducting Medical Affairs Activities and conducting Phase 4 Clinical Trials, and interacting with Regulatory Authorities or other Governmental Authorities regarding any of the foregoing. When used as a verb, \"to Commercialize\" means to engage in Commercialization, and \"Commercialized\" has a corresponding meaning.", "": "" }, { "Text": "1.46 \"Commercially Reasonable Efforts\" means, (a) with respect to the efforts and resources to be expended by AbbVie with respect to any objective, activity, or decision to be undertaken, such reasonable efforts and resources to accomplish such objective, activity, or decision that would be comparable with the efforts and resources that AbbVie would normally use in the exercise of its reasonable business discretion to accomplish a similar objective, activity, or decision with respect to a compound or product that is at a similar stage in its development or product life, is in a similar therapeutic and disease area, and is of similar market potential taking into account all relevant factors (including legal, medical, scientific, technical, and commercial factors), including issues of safety and efficacy, expected and actual cost and time to develop, expected and actual profitability, expected and actual competitiveness of alternative products (including generic or biosimilar products) in the marketplace, the nature and extent of expected and actual market exclusivity (including patent coverage and regulatory exclusivity), the expected likelihood of Regulatory Approval, the expected and actual reimbursability and pricing, and the expected and actual amounts of marketing and promotional expenditures required; and (b) with respect to the efforts and resources to be expended by Anima with respect to any objective, activity, or decision to be undertaken, such reasonable, diligent, and good faith efforts that would be comparable with the efforts and resources normally used in the biotechnology industry for comparable research and development of novel biopharmaceutical products. In addition, with regard to AbbVie's obligations relating to the Exploitation of Royalty-Bearing Compound(s) and Royalty-Bearing Product(s) hereunder, \"Commercially Reasonable Efforts\" shall be determined on a country-by-country or market-by-market basis (as most applicable) for a particular product, and it is anticipated that the level of effort will change over time, including to reflect changes in the status of the product and the countries (or markets) involved. For clarity, where a Party has an obligation to use Commercially Reasonable Efforts, the efforts of such Party and its Affiliates, subcontractors and (sub)licensees/Sublicensees (other than Dispute Settlement Sublicensees) shall be considered in determining whether such Party has satisfied such obligation. To the extent that the performance of a Party's obligations hereunder is adversely affected by the other Party's failure to perform its obligations hereunder, the impact of such performance failure shall be taken into account in determining whether such Party has used its Commercially Reasonable Efforts to perform any such affected obligations.", "": "" }, { "Text": "1.47 \"Committee\" has the meaning set forth in Section 3.2(f) (Responsibilities).", "": "" }, { "Text": "1.48 \"Confidential Information\" means any information or data provided orally, visually, in writing, or in any other form by or on behalf of one (1) Party (or an Affiliate or representative of such Party) to the other Party (or to an Affiliate or representative of such Party) in connection with this Agreement, whether prior to, on, or after the Effective Date, including: information relating to the terms of this Agreement, a Royalty-Bearing Compound, a Royalty-Bearing Product (including Regulatory Filings), or any Exploitation of a Royalty-Bearing Compound or Royalty-Bearing Product; any Know-How with respect thereto developed by or on behalf of the disclosing Party or its Affiliates; or the scientific, regulatory, or business affairs or other activities of either Party. In addition, each Party's confidential information under the CDA will be deemed to be such Party's Confidential Information under this Agreement. Notwithstanding the foregoing: (a) the existence and terms of this Agreement shall be deemed to be the Confidential Information of both Parties, and both Parties shall be deemed to be the receiving Party and the disclosing Party with respect thereto; (b) on a Target Program Slot-by-Target Program Slot basis, before the License Option Effective Date with respect to such Target Program Slot, the License Option Exercise Data Package with respect to such Target Program Slot shall be deemed to be the Confidential Information of both Parties, and both Parties shall be deemed to be the receiving Party and the disclosing Party with respect thereto; (c) on a Target Program Slot-by-Target Program Slot basis, after the License Option Effective Date with respect to such Target Program Slot, the License Option Exercise Data Package will be deemed to be the Confidential Information of AbbVie, and AbbVie shall be deemed to be the disclosing Party and Anima shall be deemed to be the receiving Party with respect thereto; (d) all reports provided by AbbVie to Anima under Section 7.12 (Reports; Payment of Royalty) shall be deemed to be the Confidential Information of AbbVie, and AbbVie shall be deemed to be the disclosing Party and Anima shall be deemed to be the receiving Party with respect thereto; and (e) the fact that the Anima Compound Library and any compound therein were used in the collaboration under this Agreement shall be deemed to be the Confidential Information of AbbVie, and AbbVie shall be deemed to be the disclosing Party and Anima shall be deemed to be the receiving Party with respect thereto.", "": "" }, { "Text": "1.49 \"Control\" means, subject to Section 14.3.2 (Assignment), with respect to a Person and any Regulatory Filings, material, Know-How, Patent Right, or other intellectual property right, the possession by such Person or any of its Affiliates of the right, whether through ownership or license (other than by a license under this Agreement), to grant the licenses, sublicenses, or other rights as provided herein without violating the terms of any agreement or other arrangement with any Third Party.", "": "" }, { "Text": "1.50 \"Convicted Individual\" or \"Convicted Entity\" means an individual or entity, as applicable, who has been convicted of a criminal offense that falls within the ambit of 21 U.S.C. §335a (a) or 42 U.S.C. §1320a - 7(a), but has not yet been excluded, debarred, suspended, or otherwise declared ineligible.", "": "" }, { "Text": "1.51 \"Credentialed MoA Target\" means a mechanism of action target identified in the License Option Exercise Data Package that satisfies the success criteria set forth in the \"Lead Generation – Mode of action and target ID\" section of Exhibit C-2.", "": "" }, { "Text": "1.52 \"Data Security and Privacy Laws\" means all applicable Laws relating to the privacy, Processing, or security of Personal Data.", "": "" }, { "Text": "1.53 \"Debarred Entity\" means a corporation, partnership, or association that has been debarred by the FDA pursuant to 21 U.S.C. §335a (a) or (b) from submitting or assisting in the submission of any abbreviated drug application, or a subsidiary or Affiliate of a Debarred Entity.", "": "" }, { "Text": "1.54 \"Debarred Individual\" means an individual who has been debarred by the FDA pursuant to 21 U.S.C. §335a (a) or (b) from providing services in any capacity to a Person that has an approved or pending drug or biological product application.", "": "" }, { "Text": "1.55 \"Default Notice\" has the meaning set forth in Section 13.2.1(a) (Material Breach).", "": "" }, { "Text": "1.56 \"Development\" means all activities related to research, pre-clinical and other non-clinical testing, test method development and stability testing, toxicology, formulation, process development, manufacturing scale-up, qualification and validation, quality assurance/quality control, Clinical Trials (other than Phase 4 Clinical Trials), including Manufacturing in support thereof, statistical analysis and report writing, the preparation and submission of Regulatory Approval Applications, regulatory affairs with respect to the foregoing, and all other activities necessary or reasonably useful or otherwise requested or required by a Regulatory Authority as a condition or in support of obtaining or maintaining a Regulatory Approval. When used as a verb, \"Develop\" means to engage in Development and \"Developed\" means to have engaged in Development. Notwithstanding the foregoing, Development does not include any Commercialization activities.", "": "" }, { "Text": "1.57 \"Development Milestone Event\" has the meaning set forth in Section 7.6 (Development and Regulatory Milestone Payments).", "": "" }, { "Text": "1.58 \"Development Milestone Payment\" has the meaning set forth in Section 7.6 (Development and Regulatory Milestone Payments).", "": "" }, { "Text": "1.59 \"Directed To\" means, (a) with respect to a Collaboration Target and a compound, that such compound binds to, inhibits, activates, or modulates the activity, translation, expression, or mRNA of such Collaboration Target to a level that meets the Hit Confirmation criteria of Exhibit C-1, and (b) with respect to a Reserved Target and a compound, that such compound binds to, inhibits, activates, or modulates the activity, translation, expression, or mRNA of such Reserved Target to a level that meets the Hit Confirmation criteria of Exhibit C-1.", "": "" }, { "Text": "1.60 \"Dispute\" has the meaning set forth in Section 14.2 (Dispute Resolution).", "": "" }, { "Text": "1.61 \"Dispute Settlement Sublicensee\" means any Sublicensee that is granted a sublicense under the rights granted to AbbVie under Section 4.1 (Licenses to AbbVie) (a) in order to settle a litigation or dispute related to any Patent Rights in connection with a Royalty-Bearing Product or a Generic Product thereof, including any such litigation or dispute with any Third Party that has submitted an application to a Regulatory Authority to market a Generic Product with respect to a Royalty-Bearing Product or (b) pursuant to a compulsory license or otherwise as a result of the actions of any Governmental Authority.", "": "" }, { "Text": "1.62 \"Distracting Product\" has the meaning set forth in Section 8.1.2 (Effect of Change of Control of Anima).", "": "" }, { "Text": "1.63 \"Distributor\" means any Person appointed by AbbVie or any of its Affiliates or its or their Sublicensees (other than Dispute Settlement Sublicensees) to distribute, market, and sell a Royalty-Bearing Product with or without packaging rights, in one (1) or more countries in the Territory, in circumstances where such Person purchases its requirements of such Royalty-Bearing Product from AbbVie or its Affiliates or its or their Sublicensees (other than Dispute Settlement Sublicensees).", "": "" }, { "Text": "1.64 \"DOJ\" means the Antitrust Division of the United States Department of Justice, and any successor entity thereto.", "": "" }, { "Text": "1.65 \"Dollars\" or \"$\" means the legal tender of the U.S.", "": "" }, { "Text": "1.66 \"EMA\" means the European Medicines Agency, and any successor entity thereto.", "": "" }, { "Text": "1.67 \"EU\" means the European Union as constituted as of the Effective Date and any other country or countries admitted to the European Union from time to time.", "": "" }, { "Text": "1.68 \"Excluded ADC\" means any compound for which the applicable ADC Inclusion Date occurs prior to the initiation of hit validation activities under the applicable Collaboration Plan and that is (a) independently developed by Anima prior to the applicable ADC Inclusion Date pursuant to a definitive agreement between Anima and a Third Party executed prior to the ADC Inclusion Date, wherein Anima granted such Third Party exclusive rights to exploit such compound, (b) independently developed by Anima prior to the ADC Inclusion Date pursuant to a bona fide internal research program where such research program has completed hit confirmation and characterization (as such terms are defined in Exhibit B-1) prior to the ADC Inclusion Date, or (c) acquired or exclusively licensed by Anima from a Third Party prior to the applicable ADC Inclusion Date, provided that (i) the purpose of such acquisition or exclusive license was to obtain rights to such specific compound and not to obtain rights to a compound library or any other collection of compounds, (ii) as of the ADC Inclusion Date such compound is not the subject of any definitive agreement between Anima and a Third Party (other than the Third Party with whom the agreement to acquire or exclusively license such compound has been signed) or any internal research program, and (iii) as of the effective date of the definitive agreement for such acquisition or exclusive license, the compound was not known to Anima or its Affiliate to bind to, inhibit, activate, or modulate the activity, translation, expression, or mRNA of a Collaboration Target, in each case (a)-(c) without breaching Anima's exclusivity obligations in Section 8.1.1 (Anima Exclusivity Obligation).", "": "" }, { "Text": "1.69 \"Excluded Individual\" or \"Excluded Entity\" means: (a) an individual or entity, as applicable, who has been excluded, debarred, suspended, or is otherwise ineligible to participate in federal health care programs such as Medicare or Medicaid by the Office of the Inspector General (OIG/HHS) of the U.S. Department of Health and Human Services; or (b) is an individual or entity, as applicable, who has been excluded, debarred, suspended, or is otherwise ineligible to participate in federal procurement and non-procurement programs, including those produced by the U.S. General Services Administration (GSA).", "": "" }, { "Text": "1.70 \"Excluded Target\" has the meaning set forth in Section 2.5.1 (Available Targets and Excluded Targets).", "": "" }, { "Text": "1.71 \"Executive Officers\" means the Chief Executive Officer, or his or her designee, in the case of Anima, and the Vice President and Global Head Discovery Research, or his or her designee, in the case of AbbVie.", "": "" }, { "Text": "1.72 \"Existing In-License Agreements\" means the licenses and other agreements between Anima or any of its Affiliates and a Third Party existing as of the Effective Date under which Anima or its Affiliates is granted a (sub)license or other right to be used or practiced in the conduct of activities allocated to Anima under this Agreement (including under any Collaboration Plan), as amended from time to time in accordance with this Agreement. Schedule 1.72 (Existing In-License Agreements) sets forth all Existing In-License Agreements as of the Effective Date. For the avoidance of doubt, the inclusion of an agreement in Schedule 1.72 (Existing In-License Agreements) shall in no way be interpreted to mean that AbbVie has received a sublicense to such an agreement.", "": "" }, { "Text": "1.73 \"Existing Patent Rights\" has the meaning set forth in Section 11.2 (Representations, Warranties, and Covenants, as applicable, of Anima).", "": "" }, { "Text": "1.74 \"Exploit,\" \"Exploiting,\" or \"Exploitation\" means to make, have made, import, export, use, have used, sell, have sold, or offer for sale, including to research, Develop, Commercialize, register, modify, enhance, improve, Manufacture, have Manufactured, hold, or keep (whether for disposal or otherwise), formulate, optimize, have used, export, transport, distribute, promote, market, have sold, or otherwise dispose of.", "": "" }, { "Text": "1.75 \"FDA\" means the United States Food and Drug Administration, and any successor entity thereto.", "": "" }, { "Text": "1.76 \"FDA's Disqualified/Restricted List\" means the list of clinical investigators restricted from receiving investigational drugs, biologics, or devices if the FDA has determined that the investigators have repeatedly or deliberately failed to comply with regulatory requirements for studies or have submitted false information to the study sponsor or the FDA.", "": "" }, { "Text": "1.77 \"FFDCA\" means the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., as amended from time to time, together with any rules, regulations, and requirements promulgated thereunder (including all additions, supplements, extensions, and modifications thereto).", "": "" }, { "Text": "1.78 \"Field\" means all human and non-human diagnostic, prophylactic, and therapeutic uses.", "": "" }, { "Text": "1.79 \"First Commercial Sale\" means, with respect to a Royalty-Bearing Product and a country in the Territory, the first sale for monetary value and for end use or consumption of such Royalty-Bearing Product in such country after all Regulatory Approvals for the sale of such Royalty-Bearing Product in such country have been granted by the applicable Regulatory Authority or Governmental Authority of such country. Sales prior to receipt of all Regulatory Approvals for such Royalty-Bearing Product in such country, such as so-called \"treatment IND sales,\" \"named patient sales,\" and \"compassionate use sales,\" shall not be construed as a First Commercial Sale.", "": "" }, { "Text": "1.80 \"FTC\" means the United States Federal Trade Commission, and any successor entity thereto.", "": "" }, { "Text": "1.81 \"Gatekeeper\" has the meaning set forth in Section 2.4 (Gatekeeper).", "": "" }, { "Text": "1.82 \"Gatekeeping Term\" has the meaning set forth in Section 2.5.1 (Available Target Selection).", "": "" }, { "Text": "1.83 \"Generic Product\" means, with respect to a Royalty-Bearing Product, any product sold by a Third Party that is approved, or sought to be approved, by a Regulatory Authority in reliance, in whole or in part, on the prior approval (or on safety or efficacy data submitted in support of the prior approval) of such Royalty-Bearing Product as determined by the applicable Regulatory Authority, including any product authorized for sale (a) in the U.S. pursuant to Section 505(b)(2) or Section 505(j) of the FFDCA (21 U.S.C. 355(b)(2) and 21 U.S.C. 355(j), respectively), (b) in the EU pursuant to a provision of Articles 10, 10a, or 10b of Parliament and Council Directive 2001/83/EC as amended (including an application under Article 6.1 of Parliament and Council Regulation (EC) No 726/2004 that relies for its content on any such provision), or (c) in any other country or jurisdiction pursuant to all equivalents of such provisions, including any amendments and successor statutes with respect to the subsections (a) through (c) thereto. For clarity, a product licensed, marketed, sold, manufactured, or produced by AbbVie, its Affiliates, or Sublicensees under the same NDA as the Royalty-Bearing Product will not constitute a Generic Product.", "": "" }, { "Text": "1.84 \"Governmental Authority\" means any multinational, federal, national, state, provincial, local, or other entity, office, commission, bureau, agency, political subdivision, instrumentality, branch, department, authority, board, court, arbitral, or other tribunal exercising executive, judicial, legislative, police, regulatory, administrative, or taxing authority, or functions of any nature pertaining to government.", "": "" }, { "Text": "1.85 \"Hit Validation Data Package\" has the meaning set forth in Section 1.105 (\"License Option Exercise Data Package\").", "": "" }, { "Text": "1.86 \"HSR Act\" means the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended.", "": "" }, { "Text": "1.87 \"HSR Clearance\" means the earlier of (a) notification to the Parties from the FTC or DOJ of early termination of the applicable waiting period under the HSR Act with respect to the HSR Filings, or (b) expiration of the applicable waiting period under the HSR Act with respect to the HSR Filings; provided, however, that if the FTC or DOJ commences any investigation by means of a Second Request or otherwise, HSR Clearance means the termination of such investigation, without action to prevent the Parties from implementing the transactions contemplated by this Agreement with respect to the United States.", "": "" }, { "Text": "1.88 \"HSR Extension Period\" has the meaning set forth in Section 2.11.1 (HSR).", "": "" }, { "Text": "1.89 \"HSR Filings\" means the filings by Anima and AbbVie with the FTC and the DOJ of a Notification and Report Form for Certain Mergers and Acquisitions (as that term is defined in the HSR Act) with respect to the matters set forth in this Agreement, together with all required documentary attachments thereto.", "": "" }, { "Text": "1.90 \"In-License Agreement\" means (a) any Existing In-License Agreement, and (b) any other agreement between Anima or its Affiliate, on one hand, and a Third Party, on the other hand, under which (i) AbbVie is granted a sublicense or other right under this Agreement as provided in Section 4.6 (In-License Agreements), or (ii) Anima or its Affiliates is granted a (sub)license or other right to be used or practiced in the conduct of activities allocated to Anima under this Agreement.", "": "" }, { "Text": "1.91 \"In-License Agreement Notification Period\" has the meaning set forth in Section 4.6 (In-License Agreements).", "": "" }, { "Text": "1.92 \"IND\" means an application filed with a Regulatory Authority for authorization to commence Clinical Trials, including (a) an Investigational New Drug Application as defined in the FFDCA or any successor application or procedure filed with the FDA, (b) any equivalent of a United States IND in other countries or regulatory jurisdictions, (i.e., a clinical trial application (CTA)), and (c) all supplements, amendments, variations, extensions, and renewals thereof that may be filed with respect to the foregoing.", "": "" }, { "Text": "1.93 \"IND-Enabling Studies\" means, with respect to a Royalty-Bearing Product that has achieved candidate selection in accordance with AbbVie's internal policies and procedures, those studies contemplated to be conducted by AbbVie in Section 8 of Exhibit B-1.", "": "" }, { "Text": "1.94 \"Independent Affiliate\" has the meaning set forth in Section 14.3.2 (Assignment).", "": "" }, { "Text": "1.95 \"Inflation Reduction Act\" means P.L. 117-169 (Aug. 16, 2022), as codified at 42 U.S.C. § 1320f, 42 U.S.C. § 1395w-3a and 42 U.S.C. § 1395w-114a (inter alia), and as it may be amended from time to time, together with any rules, regulations, and requirements promulgated thereunder (including all additions, supplements, extensions, and modifications thereto).", "": "" }, { "Text": "1.96 \"Initial Target Program Slot\" has the meaning set forth in Section 2.2.1 (Initial Target Program Slots).", "": "" }, { "Text": "1.97 \"Intellectual Property\" means all copyrights, Patents Rights, Trademarks, service marks, goodwill, moral rights, Know-How, and any and all other intellectual property or proprietary rights (including applications relating thereto), whether or not now known or hereafter recognized in any jurisdiction.", "": "" }, { "Text": "1.98 \"Japan PMDA\" means Japan's Pharmaceuticals and Medical Devices Agency and any successor agency or authority having substantially the same function.", "": "" }, { "Text": "1.99 \"Know-How\" means all knowledge, materials, and information of a technical, scientific, business, and other nature, including: inventions, know-how, technology, means, methods, processes, practices, formulae, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings, assembly procedures, computer programs, apparatuses, specifications, data, results and other material, Regulatory Filings, and other biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical, pre-clinical, clinical, safety, manufacturing, and quality control data and information, including study designs and protocols, reagents (e.g., plasmids, proteins, cell lines, assays, and compounds), and biological methodology; in each case (whether or not confidential, proprietary, patented, or patentable, of commercial advantage or not) in written, electronic, or any other form now known or hereafter developed.", "": "" }, { "Text": "1.100 \"Knowledge\" means, with respect to Anima, the knowledge of the chief executive officer, chief business officer, chief scientific officer, chief operating officer, and each vice president of Anima or any of its Affiliates or any personnel holding positions equivalent to such job titles (but only to the extent such positions exist at such entity) after performing a diligent investigation (including consulting any direct reports and consulting Anima's external legal counsel, including Anima's external intellectual property counsel) with respect to the applicable facts and information.", "": "" }, { "Text": "1.101 \"Law\" means federal, state, local, national, and supra-national laws, statutes, rules, and regulations, including any rules, regulations, regulatory guidelines, or other requirements of the Regulatory Authorities, major national securities exchanges, or major securities listing organizations, that may be in effect from time to time during the Term and applicable to a particular activity or country or other jurisdiction hereunder.", "": "" }, { "Text": "1.102 \"Lead Optimization Data Package\" has the meaning set forth in Section 1.105 (\"License Option Exercise Data Package\").", "": "" }, { "Text": "1.103 \"License Option\" has the meaning set forth in Section 2.9.1 (Grant of License Option).", "": "" }, { "Text": "1.104 \"License Option Effective Date\" means, with respect to each Target Program Slot, the date upon which AbbVie delivers to Anima the License Option Exercise Notice with respect to such Target Program Slot in accordance with Section 14.5 (Notices); provided that, if AbbVie determines in its sole discretion prior to the delivery of any License Option Exercise Notice that the transactions to be consummated upon the exercise of the applicable License Option require HSR Filings, then the applicable License Option Effective Date shall mean the Business Day following the date on which the applicable HSR Clearance occurs.", "": "" }, { "Text": "1.105 \"License Option Exercise Data Package\" means, with respect to each Target Program Slot:", "": "" }, { "Text": "1.105.1 prior to AbbVie's payment of the License Option Period Extension Fee for the then-current Collaboration Target for such Target Program Slot, a data package containing all data (including raw data), findings, results, and information demonstrating the achievement of the success criteria set forth in Exhibit C-1 attached hereto with respect to the then-current Collaboration Target for such Target Program Slot (the \"Hit Validation Data Package\"); and", "": "" }, { "Text": "1.105.2 following AbbVie's payment of the License Option Period Extension Fee for the then-current Collaboration Target for such Target Program Slot, a data package containing all data (including raw data), findings, results, and information demonstrating the achievement of the success criteria set forth in Exhibit C-2 attached hereto with respect to the then-current Collaboration Target for such Target Program Slot (the \"Lead Optimization Data Package\").", "": "" }, { "Text": "1.106 \"License Option Exercise Fee\" has the meaning set forth in Section 7.5 (License Option Exercise Fee).", "": "" }, { "Text": "1.107 \"License Option Exercise Notice\" has the meaning set forth in Section 2.9.3(a) (Exercise of License Option).", "": "" }, { "Text": "1.108 \"License Option Period\" means, with respect to each Target Program Slot, the time period commencing on the Effective Date (or, with respect to any Additional Target Program Slot, the date on which such Additional Target Program Slot is selected) and terminating as follows:", "": "" }, { "Text": "1.108.1 prior to AbbVie's payment of the License Option Period Extension Fee for the then-current Collaboration Target for such Target Program Slot, and subject to extension pursuant to Section 2.11 (HSR), sixty (60) days after AbbVie's acceptance of a Hit Validation Data Package provided by Anima for the then-current Collaboration Target for such Target Program Slot, which data package contains all of the information required to be in such data package; and", "": "" }, { "Text": "1.108.2 following AbbVie's payment of the License Option Period Extension Fee for the then-current Collaboration Target for such Target Program Slot, and subject to extension pursuant to Section 2.11 (HSR), one hundred and eighty (180) days after AbbVie's acceptance of a Lead Optimization Data Package provided by Anima for the then-current Collaboration Target for such Target Program Slot, which data package contains all of the information required to be in such data package.", "": "" }, { "Text": "1.109 \"License Option Period Extension Fee\" has the meaning set forth in Section 7.4 (License Option Period Extension Fee).", "": "" }, { "Text": "1.110 \"Licensed IP\" means Anima's and its Affiliates' rights, title, and interests in and to the Collaboration Patents and the Collaboration Know-How (including, for clarity, the ADC Royalty-Bearing Compounds). For clarity, Licensed IP excludes Anima Platform Technology, Anima Background Patents, Anima Background Know-How, and Anima Improvements.", "": "" }, { "Text": "1.111 \"Major European Market\" means each of France, Germany, Italy, Spain, or the UK.", "": "" }, { "Text": "1.112 \"Manufacture\" and \"Manufacturing\" means all activities related to the synthesis, making, production, processing, purifying, formulating, filling, finishing, packaging, labeling, shipping, and holding of Royalty-Bearing Compounds, any Royalty-Bearing Products, or any intermediates thereof, including process development, process qualification and validation, scale-up, pre-clinical, clinical, and commercial production and analytic development, product characterization, stability testing, quality assurance, and quality control. When used as a verb, \"Manufactured\" means to have engaged in Manufacturing.", "": "" }, { "Text": "1.113 \"Medical Affairs Activities\" means, with respect to any country or other jurisdiction in the Territory, the coordination of medical information requests and field based medical scientific liaisons with respect to Royalty-Bearing Compounds or Royalty-Bearing Products, including activities of medical scientific liaisons and the provision of medical information services with respect to a Royalty-Bearing Compound or Royalty-Bearing Product.", "": "" }, { "Text": "1.114 \"Mono Product\" has the meaning set forth in Section 1.116(a) (\"Net Sales\").", "": "" }, { "Text": "1.115 \"NDA\" means a New Drug Application, as defined in the FFDCA, or any corresponding foreign application in the Territory, including, with respect to the EU, a Regulatory Approval Application filed with the EMA pursuant to the Centralized Approval Procedure or with the applicable Regulatory Authority of a country in Europe with respect to the mutual recognition or any other national approval procedure.", "": "" }, { "Text": "1.116 \"Net Sales\" means with respect to any Royalty-Bearing Product, the gross amount invoiced by AbbVie, any of its Affiliates, or any Sublicensee (other than a Dispute Settlement Sublicensee) (each, a \"Selling Party\") to a Third Party (including a customer, Distributor, wholesaler, or end user) in bona fide arm's length transactions, less the following deductions, in each case related specifically to the Royalty-Bearing Product and actually allowed and taken by such Third Parties and not otherwise recovered by or reimbursed to AbbVie, its Affiliates, or Sublicensees (other than Dispute Settlement Sublicensees):", "": "" }, { "Text": "1.116.1 trade, cash, and quantity discounts;", "": "" }, { "Text": "1.116.2 price reductions or rebates, retroactive or otherwise, imposed by, negotiated with, or otherwise paid to Governmental Authorities or other payees;", "": "" }, { "Text": "1.116.3 taxes on sales (such as sales, value added, or use taxes) to the extent added to the sale price and set forth separately as such in the total amount invoiced;", "": "" }, { "Text": "1.116.4 amounts repaid or credited by reason of rejections, defects, return goods allowance, recalls, or returns, or because of retroactive price reductions, including rebates or wholesaler charge backs;", "": "" }, { "Text": "1.116.5 the portion of administrative fees paid during the relevant time period to group purchasing organizations, pharmaceutical benefit managers, or Medicare Prescription Drug Plans relating to such Royalty-Bearing Product;", "": "" }, { "Text": "1.116.6 any invoiced amounts from a prior period which are not collected and are written off by AbbVie or its Affiliates, including bad debts;", "": "" }, { "Text": "1.116.7 that portion of the annual fee on prescription drug manufacturers imposed by the Patient Protection and Affordable Care Act, Pub. L. No. 111-148 (as amended) and reasonably allocable to sales of the Royalty-Bearing Products;", "": "" }, { "Text": "1.116.8 freight, insurance, import/export, and other transportation charges to the extent added to the sale price and set forth separately as such in the total amount invoiced, as well as any fees for services provided by wholesalers and warehousing chains related to the distribution of such Royalty-Bearing Product; and", "": "" }, { "Text": "1.116.9 any other similar and customary deductions that are consistent with the Accounting Standards, but which may not be duplicative of the deductions specified in Sections 1.116.1-1.116.8 above.", "": "" }, { "Text": "Net Sales shall not include transfers or dispositions for charitable, promotional, pre-clinical, clinical, regulatory, or governmental purposes. Net Sales shall include the amount or fair market value of all other consideration received by AbbVie, its Affiliates, or applicable Sublicensees (other than Dispute Settlement Sublicensees) in respect of the Royalty-Bearing Product, whether such consideration is in cash, payment in kind, exchange, or other form. Net Sales shall not include sales between or among AbbVie, its Affiliates, or Sublicensees.", "": "" }, { "Text": "Subject to the above, Net Sales shall be calculated in accordance with the standard internal policies and procedures of AbbVie, its Affiliates, or applicable Sublicensees (other than Dispute Settlement Sublicensees), which must be in accordance with Accounting Standards.", "": "" }, { "Text": "For purposes of calculating Net Sales, all Net Sales shall be converted into Dollars in accordance with Section 7.15 (Methods of Payments; Offsets).", "": "" }, { "Text": "In the event a Royalty-Bearing Product is a Combination Product, the Net Sales for such Combination Product shall be calculated as follows:", "": "" }, { "Text": "(a) If a Selling Party separately sells in such country or other jurisdiction, (i) a product containing as its sole active ingredient(s) the Royalty-Bearing Compound(s) contained in such Combination Product (the \"Mono Product\") and (ii) products containing as their sole active ingredient(s) the other active ingredient(s) in such Combination Product, then the Net Sales attributable to such Combination Product shall be calculated by multiplying actual Net Sales of such Combination Product by the fraction A/(A+B) where: \"A\" is such Selling Party's average Net Sales price during the period to which the Net Sales calculation applies for the Mono Product in such country or other jurisdiction and \"B\" is the Selling Party's average net sales price (determined in the same manner as \"Net Sales\") during the period to which the Net Sales calculation applies in such country or other jurisdiction, for products that contain as their sole active ingredient(s) the other active ingredient(s) in such Combination Product.", "": "" }, { "Text": "(b) If a Selling Party separately sells in such country or other jurisdiction the Mono Product but does not separately sell in such country or other jurisdiction products containing as their sole active ingredient(s) the other active ingredients in such Combination Product, then the Net Sales attributable to such Combination Product shall be calculated by multiplying the Net Sales of such Combination Product by the fraction A/C where: \"A\" is such Selling Party's average Net Sales price during the period to which the Net Sales calculation applies for the Mono Product in such country or other jurisdiction, and \"C\" is the Selling Party's average Net Sales price in such country or other jurisdiction during the period to which the Net Sales calculation applies for such Combination Product.", "": "" }, { "Text": "(c) If a Selling Party does not separately sell in such country or other jurisdiction the Mono Product but does separately sell products containing as their sole active ingredient(s) the other active ingredients contained in such Combination Product, then the Net Sales attributable to such Combination Product shall be calculated by multiplying the Net Sales of such Combination Product by the fraction (D-E)/D where: \"D\" is the average Net Sales price during the period to which the Net Sales calculation applies for such Combination Product in such country or other jurisdiction and \"E\" is the average net sales price (determined in the same manner as \"Net Sales\") during the period to which the Net Sales calculation applies for products that contain as their sole active ingredient(s) the other active ingredient(s) in such Combination Product.", "": "" }, { "Text": "(d) If a Selling Party does not separately sell in such country or other jurisdiction both the Mono Product and the other active ingredient(s) in such Combination Product, then the Net Sales attributable to such Combination Product shall be determined by the Parties in good faith based on the relative fair market value of such Mono Product and such other active ingredient(s). If the Parties cannot agree on such relative fair market value, then the dispute shall be resolved pursuant to Section 14.2 (Dispute Resolution).", "": "" }, { "Text": "1.117 \"Non-Breaching Party\" has the meaning set forth in Section 13.2.1(a) (Material Breach).", "": "" }, { "Text": "1.118 \"Patent Right\" means: (a) all national, regional, and international patents and patent applications, including provisional patent applications and rights to claim priority from any of these patents or applications; (b) all patent applications filed either from such patents, patent applications, or provisional applications or from an application claiming priority from either of these, including divisionals, continuations, continuations-in-part, provisionals, converted provisionals, and continued prosecution applications; (c) any and all patents that have issued or in the future issue from the foregoing patent applications ((a) and (b)), including utility models, petty patents and design patents, and certificates of invention; (d) any and all extensions or restorations by existing or future extension or restoration mechanisms, including revalidations, reissues, re-examinations, and extensions (including any patent term extensions, supplementary protection certificates, pediatric exclusivity periods, and the like) of the foregoing patents or patent applications ((a), (b), and (c)); and (e) any similar rights, including so-called pipeline protection or any importation, revalidation, confirmation, or introduction patent or registration patent or patent of additions to any of such foregoing patent applications and patents.", "": "" }, { "Text": "1.119 \"Person\" means any individual, partnership, joint venture, limited liability company, corporation, firm, trust, association, unincorporated organization, Governmental Authority, or any other entity not specifically listed in this Section 1.119 (\"Person\").", "": "" }, { "Text": "1.120 \"Personal Data\" means: (a) all information identifying, or in combination with other information, identifiable to an individual, including pseudonymized (key-coded) Clinical Data containing such information; and (b) any other information that is governed, regulated, or protected by one (1) or more Data Security and Privacy Laws.", "": "" }, { "Text": "1.121 \"Phase 1 Clinical Trial\" means a human clinical trial of a Royalty-Bearing Compound or Royalty-Bearing Product, the principal purpose of which is a preliminary determination of safety, tolerability, pharmacological activity, or pharmacokinetics in healthy individuals or patients, or a similar clinical study prescribed by the applicable Regulatory Authorities, from time to time, pursuant to applicable Law or otherwise, including the trials referred to in 21 C.F.R. §312.21(a), as amended.", "": "" }, { "Text": "1.122 \"Phase 2 Clinical Trial\" means a human clinical trial of a Royalty-Bearing Compound or Royalty-Bearing Product, the principal purpose of which is a determination of safety and efficacy in the target patient population, which is prospectively designed to generate sufficient data that may permit commencement of a Phase 3 Clinical Trial, or a similar clinical study prescribed by the applicable Regulatory Authorities, from time to time, pursuant to applicable Law or otherwise, including the trials referred to in 21 C.F.R. §312.21(b), as amended.", "": "" }, { "Text": "1.123 \"Phase 3 Clinical Trial\" means a human clinical trial of a Royalty-Bearing Compound or Royalty-Bearing Product on a sufficient number of subjects in an indicated patient population that is designed to establish that a Royalty-Bearing Compound or Royalty-Bearing Product is safe and efficacious for its intended use and to determine the benefit/risk relationship, warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support marketing approval of such Royalty-Bearing Compound or Royalty-Bearing Product, including all tests and studies that are required by the applicable Regulatory Authorities from time to time, pursuant to applicable Law or otherwise, including the trials referred to in 21 C.F.R. §312.21(c), as amended.", "": "" }, { "Text": "1.124 \"Phase 4 Clinical Trial\" means a post-marketing human clinical study for a Royalty-Bearing Product with respect to any indication as to which Regulatory Approval has been received or for a use that is the subject of an investigator-initiated study program.", "": "" }, { "Text": "1.125 \"Post-License Option Exercise Activities\" has the meaning set forth in Section 2.10.2 (Post-License Option Exercise Activities).", "": "" }, { "Text": "1.126 \"Pricing Approval\" means such approval, agreement, determination, or decision establishing prices for a Royalty-Bearing Product that can be charged to consumers or will be reimbursed by Governmental Authorities in a country in the Territory where Governmental Authorities of such country approve or determine pricing for pharmaceutical or biological products for reimbursement or otherwise.", "": "" }, { "Text": "1.127 \"Processing\" (or its conjugates) means any operation or set of operations that is performed upon Personal Data, whether or not by automatic means, such as collection, recording, organization, storage, adaptation or alternation, retrieval, consultation, use, disclosure by transmission, dissemination or otherwise making available, alignment or combination, blocking, erasure, or destruction.", "": "" }, { "Text": "1.128 \"Product Information\" has the meaning set forth in Section 10.1 (Product Information).", "": "" }, { "Text": "1.129 \"Product Infringement\" has the meaning set forth in Section 9.4.1 (Enforcement).", "": "" }, { "Text": "1.130 \"Product Labeling\" means, with respect to a Royalty-Bearing Product in a country or other jurisdiction in the Territory, (a) the Regulatory Authority approved full prescribing information for such Royalty-Bearing Product for such country or other jurisdiction, including any required patient information, and (b) all labels and other written, printed, or graphic matter upon a container, wrapper, or any package insert utilized with or for such Royalty-Bearing Product in such country or other jurisdiction.", "": "" }, { "Text": "1.131 \"Proposed In-License Agreement\" has the meaning set forth in Section 4.6 (In-License Agreements).", "": "" }, { "Text": "1.132 \"Proposed In-Licensed Rights\" has the meaning set forth in Section 4.6 (In-License Agreements).", "": "" }, { "Text": "1.133 \"Proposed Target\" has the meaning set forth in Section 2.5.1 (Available Target Selection).", "": "" }, { "Text": "1.134 \"Ramot Agreement\" means the Settlement Agreement between Anima Biotech Inc. and Ramot at Tel Aviv University Ltd., dated February 27, 2019.", "": "" }, { "Text": "1.135 \"Registrational Clinical Trial\" means a human clinical trial of a Royalty-Bearing Product for which the applicable Regulatory Authorities have provided guidance that the design of such clinical trial and results of such clinical trial, together with prior data and information concerning such Royalty-Bearing Product, (a) are sufficient to establish that such Royalty-Bearing Product is safe and effective for its intended use and (b) forms the primary basis of an effectiveness claim in support of a Regulatory Approval for such Royalty-Bearing Product; provided that any Phase 2 Clinical Trial designed to obtain, or that obtains, an accelerated or conditional Regulatory Approval (such as an Accelerated Approval (with respect to the FDA) or Conditional Marketing Authorization (with respect to the EMA)) will not be considered a \"Registrational Clinical Trial\" for purposes of this Agreement.", "": "" }, { "Text": "1.136 \"Regulatory Approval\" means, with respect to a country or other jurisdiction in the Territory, the approvals (including Regulatory Approval Applications), licenses, registrations, or authorizations of any Regulatory Authority necessary to Commercialize a Royalty-Bearing Compound or Royalty-Bearing Product in such country or other jurisdiction, including, where applicable, (a) Pricing Approval in such country or other jurisdiction, (b) pre- and post-approval marketing authorizations (including any prerequisite Manufacturing approval or authorization related thereto), and (c) approval of Product Labeling.", "": "" }, { "Text": "1.137 \"Regulatory Approval Application\" means (a) an NDA, or (b) any other corresponding foreign application in the Territory to seek Regulatory Approval of a product in any country or multinational jurisdiction, as defined in applicable Laws and filed with the relevant Regulatory Authorities of such country or jurisdiction.", "": "" }, { "Text": "1.138 \"Regulatory Authority\" means any applicable supra-national, federal, national, regional, state, provincial, or local governmental or regulatory authority, agency, department, bureau, commission, council, or other entities (e.g., the FDA, EMA, and Japan PMDA) regulating or otherwise exercising authority with respect to activities contemplated in this Agreement, including the Exploitation of the Royalty-Bearing Compounds or Royalty-Bearing Products in the Territory.", "": "" }, { "Text": "1.139 \"Regulatory Filing\" means all: (a) applications (including all INDs and Regulatory Approval Applications), registrations, licenses, authorizations, and approvals (including Regulatory Approvals); (b) correspondence and reports submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority) and all supporting documents with respect thereto, including all regulatory drug lists, advertising and promotion documents, adverse event files, and complaint files; and (c) Clinical Data and data contained or relied upon in any of the foregoing, in each case ((a), (b), and (c)) relating to a Royalty-Bearing Compound or Royalty-Bearing Product.", "": "" }, { "Text": "1.140 \"Reserved Target\" means each target identified as a \"Reserved Target\" on Exhibit A-2.", "": "" }, { "Text": "1.141 \"Royalty-Bearing Compound\" means, with respect to a Collaboration Target for which AbbVie has exercised the License Option, any compound that is: (a) an ADC that is (i) included in the applicable License Option Exercise Data Package and (ii) not generally known to bind to, inhibit, activate, or modulate the activity or expression of a Credentialed MoA Target included in the applicable License Option Exercise Data Package (each compound described in this clause (a), a \"ADC Royalty-Bearing Compound\") or (b) Developed during the Term by or on behalf of AbbVie or its Affiliates that (i) binds to, inhibits, activates, or modulates the activity or expression of any Credentialed MoA Target included in the applicable License Option Exercise Data Package in a manner that satisfies the success criteria set forth in the \"Lead Optimization – In vitro and in vivo efficacy studies in commercially available disease models\" section of Exhibit C-2, and (ii) could not have been Developed during the Term by or on behalf of AbbVie or any of its Affiliates except through the use of Confidential Information provided by Anima to AbbVie that is (A) included in the applicable License Option Exercise Data Package and (B) specifically related to a Credentialed MoA Target included in a License Option Exercise Data Package, provided that such Confidential Information does not fall within any of the exceptions set forth in Sections 10.2.1 through 10.2.5 (each compound described in this clause (b), a \"Non-ADC Royalty-Bearing Compound\"). For clarity, AbbVie or its Affiliates may develop a compound that binds to, inhibits, activates, or modulates the activity or expression of a Credentialed MoA Target identified in a License Option Exercise Data Package through independent development that is not a Non-ADC Royalty-Bearing Compound.", "": "" }, { "Text": "1.142 \"Royalty-Bearing Product\" means any product for use in the Field comprising or containing a Royalty-Bearing Compound, alone or in combination with one (1) or more other active ingredient(s) that may or may not be Royalty-Bearing Compounds, in any form, in current and future formulations, dosage forms and strengths, and delivery modes.", "": "" }, { "Text": "1.143 \"Royalty Term\" has the meaning set forth in Section 7.9 (Royalty Term).", "": "" }, { "Text": "1.144 \"Second Request\" means a request for additional information or documentary material, as described in 16 C.F.R. 803.20.", "": "" }, { "Text": "1.145 \"Subcommittee\" has the meaning set forth in Section 3.2(f) (Responsibilities).", "": "" }, { "Text": "1.146 \"Sublicensee\" has the meaning set forth in Section 4.2 (Sublicensing Rights).", "": "" }, { "Text": "1.147 \"Target Program Slot\" means a collaboration program for the conduct of discovery, research, and development activities pursuant to a Collaboration Plan. Each Target Program Slot will correspond to a single Collaboration Plan and, at any given time, a single Collaboration Target. Target Program Slot includes the Initial Target Program Slots and the Additional Target Program Slots.", "": "" }, { "Text": "1.148 \"Term\" has the meaning set forth in Section 13.1 (Term).", "": "" }, { "Text": "1.149 \"Terminated Product\" means each Royalty-Bearing Product that is the subject of termination under this Agreement. If the Agreement is terminated in its entirety, then all Royalty-Bearing Products shall be Terminated Products.", "": "" }, { "Text": "1.150 \"Terminated Target\" means each Collaboration Target that is the subject of termination under this Agreement. If the Agreement is terminated in its entirety, then all Collaboration Targets shall be Terminated Targets.", "": "" }, { "Text": "1.151 \"Terminated Territory\" has the meaning set forth in Section 13.5 (Effects of Termination in Terminated Territory).", "": "" }, { "Text": "1.152 \"Territory\" means worldwide.", "": "" }, { "Text": "1.153 \"Third Party\" means any Person that is neither a Party nor an Affiliate of a Party.", "": "" }, { "Text": "1.154 \"Third Party Infringement Claim\" has the meaning set forth in Section 9.5 (Infringement Claims by Third Parties).", "": "" }, { "Text": "1.155 \"Third Party Right\" means any Patent Right, Know-How, or other intellectual property right of a Third Party in any country in the Territory.", "": "" }, { "Text": "1.156 \"Trademark\" means any word, name, symbol, color, shape, designation, or any combination thereof, including any trademark, service mark, trade name, brand name, sub-brand name, trade dress, product configuration, program name, delivery form name, certification mark, collective mark, logo, tagline, slogan, design, or business symbol, that functions as an identifier of source or origin, whether or not registered, and all statutory and common law rights therein, and all registrations and applications therefor, together with all goodwill associated with, or symbolized by, any of the foregoing.", "": "" }, { "Text": "1.157 \"UK\" means the United Kingdom of Great Britain and Northern Ireland.", "": "" }, { "Text": "1.158 \"United States\" or \"U.S.\" means the United States of America and all of its territories and possessions.", "": "" }, { "Text": "1.159 \"UPenn\" has the meaning set forth in Section 1.161 (\"UPenn Technology\").", "": "" }, { "Text": "1.160 \"UPenn Agreement\" has the meaning set forth in Section 1.161 (\"UPenn Technology\").", "": "" }, { "Text": "1.161 \"UPenn Technology\" means \"Penn Patent Rights,\" \"Technical Information,\" and \"Know-How,\" in each case as defined in the Patent License Agreement between Anima Biotech Inc. and The Trustees of the University of Pennsylvania (\"UPenn\"), dated June 25, 2010, as amended by that certain First Amendment to Patent License Agreement dated September 13, 2011, in the form such agreement exists as of the Effective Date (the \"UPenn Agreement\").", "": "" }, { "Text": "1.162 \"Voting Stock\" has the meaning set forth in Section 1.34.1 (\"Change of Control\").", "": "" }, { "Text": "1.163 \"Withholding Amount\" has the meaning set forth in Section 7.16.2 (Withholding Taxes).", "": "" }, { "Text": "ARTICLE 2 DEVELOPMENT; LICENSE OPTION", "": "" }, { "Text": "2.1 Overview. On a Target Program Slot-by-Target Program Slot basis, during the applicable Collaboration Term for such Target Program Slot, Anima will perform and complete certain discovery, research, and development activities in accordance with the terms of this Agreement and the applicable Collaboration Plan to generate and develop small molecule post transcriptional modulating compounds that are Directed To Collaboration Targets corresponding to each of the Target Program Slots.", "": "" }, { "Text": "2.2 Target Program Slots.", "": "" }, { "Text": "2.2.1 Initial Target Program Slots. The initial Collaboration Targets for the first three (3) Target Program Slots as of the Effective Date (each, an \"Initial Target Program Slot\") are identified as \"Initial Collaboration Targets\" in Exhibit A-1 attached hereto.", "": "" }, { "Text": "2.2.2 Additional Target Program Slots. At any time following the Effective Date and until the five- (5-) year anniversary thereof, AbbVie will have the right to select up to three (3) additional Target Program Slots (each, an \"Additional Target Program Slot\") in accordance with the terms of this Section 2.2.2 (Additional Target Program Slots). For each Additional Target Program Slot, AbbVie will provide a written notice to Anima that will identify the Available Target that AbbVie has selected as the Collaboration Target with respect to such Additional Target Program Slot (each, an \"Additional Target Program Notice\"). Upon Anima's receipt of an Additional Target Program Notice: (a) an Additional Target Program Slot will be established and will be deemed to be a new \"Target Program Slot\" and the Available Target identified in such Additional Target Program Notice will be deemed to be the \"Collaboration Target\" with respect to such Target Program Slot; (b) the Parties shall enter into a Collaboration Plan for such Target Program Slot in accordance with the terms of Section 2.6.1 (Initial Collaboration Plans); and (c) following the JGC's approval of a Collaboration Plan for such Target Program Slot, AbbVie will pay to Anima the Additional Target Program Fee in accordance with the terms of Section 7.2 (Additional Target Program Fee).", "": "" }, { "Text": "2.3 Collaboration Target Substitution. On a Target Program Slot-by-Target Program Slot basis, AbbVie will have the right to substitute the Collaboration Target with respect to each Target Program Slot with an Available Target up to a total of two (2) times per Target Program Slot (i.e., replace the original Collaboration Target with an Available Target and then replace such target again with a different Available Target) without cause in accordance with the terms of this Section 2.3 (Collaboration Target Substitution). For each proposed substitution, AbbVie will provide a written notice to Anima that will identify (a) the Collaboration Target that AbbVie intends to replace and (b) the Available Target that will replace such Collaboration Target (each, a \"Collaboration Target Substitution Notice\"). Upon Anima's receipt of a Collaboration Target Substitution Notice: (i) the Available Target identified in such Collaboration Target Substitution Notice will be deemed to be a \"Collaboration Target\" with respect to the applicable Target Program Slot; (ii) the replaced Collaboration Target will no longer be deemed to be a \"Collaboration Target\"; (iii) the Parties will amend the Collaboration Plan for the applicable Target Program Slot to account for such substitution in accordance with the terms of Section 2.6.2 (Amendments to Collaboration Plans); and (iv) solely if applicable, AbbVie will pay to Anima the Collaboration Target Substitution Fee in accordance with the terms of Section 7.3 (Collaboration Target Substitution Fee).", "": "" }, { "Text": "2.4 Gatekeeper. Within thirty (30) days after the Effective Date, the Parties will appoint an independent Third Party legal counsel reasonably acceptable to both Parties (the \"Gatekeeper\") to carry out the functions of the Gatekeeper as set out in this Agreement, provided that Anima will not unreasonably withhold, delay, or condition its consent to the appointment of a Gatekeeper and will not withhold its consent to the appointment of Honigman LLP as Gatekeeper in the event AbbVie reasonably determines that Honigman LLP has the appropriate expertise to act as the Gatekeeper. The fees of the Gatekeeper will be shared equally by the Parties. The Parties shall require that the Gatekeeper keep the identity of any Proposed Target and any potential Excluded ADC confidential and the Gatekeeper shall not disclose the identity of any Proposed Target to Anima or its Affiliates or any potential Excluded ADC to AbbVie.", "": "" }, { "Text": "2.5 Selection of Available Targets. All Reserved Targets shall be deemed to be Available Targets. A target that is not a Reserved Target may only be deemed to be an Available Target in accordance with the terms of this Section 2.5 (Selection of Available Targets), unless the Parties otherwise mutually agree that such target is an Available Target.", "": "" }, { "Text": "2.5.1 Available Targets and Excluded Targets. If, during the period when AbbVie has the right to select an Additional Target Program Slot pursuant to Section 2.2.2 (Additional Target Program Slots) or substitute a Collaboration Target pursuant to Section 2.3 (Collaboration Target Substitution) (the \"Gatekeeping Term\"), AbbVie wishes to select an Additional Target Program Slot pursuant to Section 2.2.2 (Additional Target Program Slots) or to substitute a Collaboration Target pursuant to Section 2.3 (Collaboration Target Substitution), then AbbVie shall provide the Gatekeeper in writing with the name of the proposed target for such Additional Target Program Slot or substitution (each a \"Proposed Target\"), together with any known alternative names or synonyms of such target. Within five (5) Business Days of receiving AbbVie's aforementioned notice, the Gatekeeper shall request that Anima provide the Gatekeeper with a list of all Excluded Targets as of such date together with proof that such targets are Excluded Targets, and Anima shall provide the foregoing information to the Gatekeeper within ten (10) Business Days of receiving such request. With respect to each Proposed Target, if Anima has included such Proposed Target on its list of Excluded Targets and provided proof to the satisfaction of the Gatekeeper that: (a) Anima has entered into a definitive agreement, received a bona fide proposal for a non-binding term sheet on material terms for a definitive agreement, or executed a bona fide non-binding term sheet on material terms for a definitive agreement, in each case with respect to a transaction with a Third Party pursuant to which Anima has granted, or would be obliged to grant, such Third Party the right to Exploit compounds directed to such Proposed Target, or (b) Anima has commenced a bona fide internal research program to Exploit compounds directed to such Proposed Target where such research program has completed high throughput screening or otherwise has generated molecules with hit confirmation level activity against such Proposed Target (any such Proposed Target, an \"Excluded Target\"), then the Gatekeeper shall conclude that such Proposed Target is an Excluded Target and inform AbbVie of the same within five (5) Business Days of receiving Anima's list of Excluded Targets. Otherwise, the Gatekeeper shall inform AbbVie that such Proposed Target is an Available Target.", "": "" }, { "Text": "2.5.2 Available Target Selection. After the Gatekeeper has determined that a Proposed Target is an Available Target, upon AbbVie's request, Anima will perform in silico target feasibility analysis with respect to such Proposed Target (to the extent not already performed by Anima), at Anima's expense, and provide AbbVie with the results of such analysis. For each Target Program Slot or proposed Additional Target Program Slot, AbbVie shall have the right to propose up to ten (10) targets for such analysis. Each Proposed Target will continue to be deemed to be an \"Available Target\" for a period of sixty (60) days following AbbVie's receipt of results of such in silico target feasibility analysis for such Proposed Target, and AbbVie may, during such sixty- (60-) day period, identify such Proposed Target as an \"Available Target\" in any Additional Target Program Notice or in any Collaboration Target Substitution Notice submitted to Anima.", "": "" }, { "Text": "2.6 Collaboration Plans.", "": "" }, { "Text": "2.6.1 Initial Collaboration Plans. The initial Collaboration Plan for each of the three (3) Initial Target Program Slots is attached as Exhibit B-1 hereto. For each Additional Target Program Slot, the Parties will, within thirty (30) days after the designation of the corresponding Collaboration Target pursuant to Section 2.2.2 (Additional Target Program Slots), and acting through a Subcommittee, prepare and submit to the JGC for approval a collaboration plan for such Additional Target Program Slot that (a) includes at least those elements set forth in Exhibit B-1, (b) includes at least those elements and approximate timelines set forth in an existing Collaboration Plan that are scientifically applicable to the activities under such new collaboration plan, and (c) is substantially similar in scientific detail and rigor to an existing Collaboration Plan, and such collaboration plan will be deemed to be a Collaboration Plan with respect to the applicable Additional Target Program Slot upon the approval of such plan by the JGC. The JGC will determine whether to approve such proposed Collaboration Plan within ten (10) Business Days after such submission to the JGC.", "": "" }, { "Text": "2.6.2 Amendments to Collaboration Plans. Either Party may propose an amendment to a Collaboration Plan by submitting (through a Subcommittee) such proposed amendment in writing to the JGC for review and approval. Upon approval of such proposed amendment in writing by the JGC, the applicable Collaboration Plan will be deemed to be amended by such amendment. Without limiting the foregoing, in the event that AbbVie substitutes a Collaboration Target with respect to a Target Program Slot, the Parties will, within thirty (30) days after the designation of the substitute Collaboration Target pursuant to Section 2.3 (Collaboration Target Substitution), and acting through a Subcommittee, prepare an amendment to the applicable Collaboration Plan to account for such substitution and submit such amendment to the JGC for review and approval.", "": "" }, { "Text": "2.7 Conduct of Collaboration Activities.", "": "" }, { "Text": "2.7.1 Responsibility. Anima will have sole responsibility for the conduct of all activities under each Collaboration Plan, except for any activities specifically allocated to AbbVie under a Collaboration Plan. Anima will bear all costs and expenses incurred by or on behalf of it in the performance of its activities under each Collaboration Plan.", "": "" }, { "Text": "2.7.2 Diligence; Data Package Submission. Anima will (a) perform and complete all activities under each Collaboration Plan in accordance with Section 2.7.3 (Timeline; Delays) and (b) use Commercially Reasonable Efforts to achieve the objectives set forth in each Collaboration Plan. Without limiting the foregoing, for each Collaboration Target, Anima will submit to AbbVie a Hit Validation Data Package and a Lead Optimization Data Package within thirty (30) days following the completion of the applicable activities under the applicable Collaboration Plan. Following AbbVie's receipt of any such License Option Exercise Data Package, AbbVie will, within thirty (30) days, either notify Anima (i) that AbbVie has accepted the applicable License Option Exercise Data Package or (ii) that such License Option Exercise Data Package is incomplete or otherwise inconsistent with the requirements of this Agreement, in which case Anima will address AbbVie's concerns and deliver to AbbVie a revised version of such License Option Exercise Data Package as promptly as practicable addressing such concerns. If AbbVie fails to notify Anima within such thirty (30) day period, or within thirty (30) days following receipt of Anima's revised License Option Exercise Data Package, that such License Option Exercise Data Package is incomplete or otherwise inconsistent with the requirements of this Agreement, then such License Option Exercise Data Package will be deemed to have been accepted by AbbVie.", "": "" }, { "Text": "2.7.3 Timeline; Delays. Anima will perform and complete all activities under each Collaboration Plan in accordance with the timelines set forth therein. If Anima fails to meet the timelines set forth in a Collaboration Plan, then Anima will not be deemed to be in breach of the obligation in the immediately preceding sentence solely to the extent such delay (a) does not have a material impact on achieving the objectives set forth in the Collaboration Plan, or (b) is caused by a bona fide technical failure beyond the reasonable control of Anima, and in each case ((a) and (b)) Anima used Commercially Reasonable Efforts to avoid and ameliorate such delay. Anima will notify AbbVie of any delay (even if remedied) at the next report to the JGC or the next JGC meeting, and the JGC will review and discuss. Anima will use Commercially Reasonable Efforts to remedy the root cause of any delay and its inability to meet the timeline set forth in the Collaboration Plan, and will implement AbbVie's reasonable suggestions with respect thereto.", "": "" }, { "Text": "2.7.4 Information and Reports. On a Target Program Slot-by-Target Program Slot basis, within thirty (30) days following the end of each Calendar Quarter during the applicable Collaboration Term for such Target Program Slot, Anima will provide to AbbVie (a) a detailed, written progress report on the status of Anima's activities under each Collaboration Plan, (b) the data resulting from Anima's activities under each Collaboration Plan, and (c) access to or copies of written reports of activities performed by or on behalf of Anima under each Collaboration Plan as may be prepared by Anima or as may be reasonably requested by AbbVie to enable AbbVie to assess Anima's progress under and compliance with this Agreement and the applicable Collaboration Plan, as applicable. On a Target Program Slot-by-Target Program Slot basis, within thirty (30) days following the end of each Calendar Year during the applicable Collaboration Term for such Target Program Slot, Anima will provide to AbbVie a report of Anima's activities performed to date under the Collaboration Plan with respect to such Target Program Slot and their costs according to the budgeted costs for the applicable activities as set forth in Exhibit B-2.", "": "" }, { "Text": "2.7.5 Anima Discovered Compounds. On a Target Program Slot-by-Target Program Slot and License Option Exercise Data Package-by-License Option Exercise Data Package basis, prior to Anima's submission of a License Option Exercise Data Package to AbbVie with respect to a Target Program Slot, Anima will update its in-process draft of such data package on a monthly basis to include in such data package, no later than the end of the calendar month which follows the month during which a compound is discovered, developed, designed, or synthesized (the last day of such calendar month, the \"ADC Inclusion Date\"), any compound that is discovered, developed, designed, or synthesized by or on behalf of Anima or its Affiliates during the conduct of activities under the applicable Collaboration Plan for such Target Program Slot; provided that, on a compound-by-compound basis, if (a) the applicable ADC Inclusion Date occurs prior to the initiation of hit validation activities under the applicable Collaboration Plan and (b) prior to the applicable ADC Inclusion Date, Anima believes that any such compound may be an Excluded ADC, then Anima will promptly provide the Gatekeeper with information on the identity (including the name (IUPAC nomenclature)) and a structural formula of such compound and supporting contemporaneous evidence that such compound is an Excluded ADC. Within ten (10) Business Days after receiving such information (and in any event, prior to the ADC Inclusion Date for such compound), the Gatekeeper will notify Anima as to whether such compound is an Excluded ADC. If the Gatekeeper determines that such compound is an Excluded ADC prior to the applicable ADC Inclusion Date, then such Excluded ADC shall not be included in any License Option Exercise Data Package, and Anima shall not be obligated to share information and reports specifically or directly related to such Excluded ADC pursuant to Section 2.7.4 (Information and Reports). If the Gatekeeper does not determine that such compound is an Excluded ADC prior to the applicable ADC Inclusion Date, then such compound will not be considered an \"Excluded ADC\" and will be included in the applicable License Option Exercise Data Package, and Anima will not have the right to subsequently remove such ADC from the applicable License Option Exercise Data Package or repeat the process set forth in this Section 2.7.5 (Anima Discovered Compounds) with respect to such compound. For clarity, no compound may be submitted to the gatekeeping process described in this Section 2.7.5 (Anima Discovered Compounds) or designated an Excluded ADC (i) after the ADC Inclusion Date for such compound or (ii) after initiation of hit validation activities under the applicable Collaboration Plan.", "": "" }, { "Text": "2.8 IP Assignment Obligation. Except where applicable Law requires otherwise: (a) Anima shall cause all Persons (including any Affiliate or Third Party subcontractor) who perform activities for Anima or its Affiliates under this Agreement or who conceive, reduce to practice, generate, discover, develop, or otherwise make any inventions on behalf of Anima or its Affiliates under this Agreement to assign their rights, title, and interest in and to any inventions resulting therefrom to Anima; (b) if Anima does not obtain such an assignment from any such Person, then Anima shall cause such Person to be contractually obligated to assign their rights in any such inventions to Anima; and (c) if Anima does not obtain such a contractual obligation from any such Person, then Anima shall cause such Person to grant to Anima an exclusive, freely sublicensable, fully paid-up, and royalty-free worldwide license under their rights in any such inventions.", "": "" }, { "Text": "2.9 License Option.", "": "" }, { "Text": "2.9.1 Grant of License Option. On a Target Program Slot-by-Target Program Slot basis, Anima hereby grants to AbbVie an exclusive first option, exercisable by AbbVie in its sole discretion during the applicable License Option Period, to obtain the AbbVie License with respect to the License Option Exercise Data Package and Collaboration Target corresponding to such Target Program Slot (each such option, a \"License Option\").", "": "" }, { "Text": "2.9.2 License Option Period Extension. On a Target Program Slot-by-Target Program Slot basis, AbbVie may extend the end date of the License Option Period with respect to any Target Program Slot by paying to Anima the License Option Period Extension Fee for the then-current Collaboration Target for such Target Program Slot at any time during the then-applicable License Option Period with respect to such Target Program Slot. For clarity, if AbbVie substitutes the Collaboration Target for a Target Program Slot, then, subject to extension pursuant to Section 2.11 (HSR), the License Option Period with respect to such Target Program Slot will end sixty (60) days after AbbVie's receipt of a Hit Validation Data Package from Anima for the substitute Collaboration Target unless AbbVie pays Anima the License Option Period Extension Fee for such substitute Collaboration Target during such License Option Period (regardless of whether AbbVie has already paid a License Option Period Extension Fee for the replaced Collaboration Target), upon which payment the License Option Period with respect to such Target Program Slot will end, subject to extension pursuant to Section 2.11 (HSR), one hundred and eighty (180) days after AbbVie's receipt of a Lead Optimization Data Package from Anima for the substitute Collaboration Target.", "": "" }, { "Text": "2.9.3 Exercise of License Option.", "": "" }, { "Text": "(a) On a Target Program Slot-by-Target Program Slot basis, AbbVie may exercise a License Option during the applicable License Option Period by, subject to Section 2.11 (HSR), providing written notice thereof to Anima (each such notice, a \"License Option Exercise Notice\").", "": "" }, { "Text": "(b) Prior to AbbVie's exercise of a License Option during the applicable License Option Period, promptly upon AbbVie's request, Anima will provide to AbbVie (i) an updated disclosure schedule with respect to Anima's representations and warranties set forth in Section 11.2 (Representations, Warranties, and Covenants, as applicable, of Anima) and (ii) copies of any in-licenses that would be In-License Agreements if AbbVie accepted a sublicense under such in-license under Section 4.6 (In-License Agreements), provided that Anima shall have the right to redact any confidential and commercially sensitive information in such In-License Agreements that is not relevant for AbbVie to assess its rights and obligations as a sublicensee thereunder.", "": "" }, { "Text": "(c) If AbbVie exercises a License Option in accordance with Section 2.9.3(a) but AbbVie does not pay to Anima the License Option Exercise Fee in accordance with Section 7.5 (License Option Exercise Fee) on or before the due date of such payment, then Anima shall deliver notice of such payment default to AbbVie and if AbbVie fails to pay to Anima the License Option Exercise Fee within ten (10) days following the date AbbVie received such notice, then as its sole remedy, Anima will have the right to revoke the AbbVie License in its entirety with immediate effect and the Collaboration Target corresponding to such Target Program Slot shall be deemed to no longer be a Collaboration Target under this Agreement.", "": "" }, { "Text": "2.10 Conduct of Post-License Option Exercise Activities.", "": "" }, { "Text": "2.10.1 Activities under Collaboration Plan. If AbbVie exercises a License Option prior to the completion of activities under the applicable Collaboration Plan, then, unless otherwise requested by AbbVie in writing, Anima will remain responsible for completing all remaining activities under such Collaboration Plan during the applicable Collaboration Term in accordance with the terms of Section 2.7 (Conduct of Collaboration Activities).", "": "" }, { "Text": "2.10.2 Post-License Option Exercise Activities. On a Target Program Slot-by-Target Program Slot basis, following AbbVie's exercise of the License Option with respect to a Target Program Slot, AbbVie may request during the applicable Collaboration Term that Anima conduct certain activities proposed by AbbVie with respect to the applicable Collaboration Target in addition to those activities allocated to Anima in the applicable Collaboration Plan (\"Post-License Option Exercise Activities\"). Anima will conduct all Post-License Option Exercise Activities upon AbbVie's request and at Anima's own cost and expense. Notwithstanding the foregoing, on a Target Program Slot-by-Target Program Slot basis, Anima will not be responsible for conducting any Post-License Option Exercise Activities beyond one thousand six hundred (1600) FTE hours per Target Program Slot, provided that Anima shall not be required to perform any Post-License Option Exercise Activities for a Target Program Slot after the date of the first IND acceptance of a Royalty-Bearing Product with respect to such Target Program Slot.", "": "" }, { "Text": "2.11 HSR.", "": "" }, { "Text": "2.11.1 If AbbVie determines in its sole discretion prior to the delivery of the License Option Exercise Notice for a License Option that the transactions to be consummated upon the exercise of the License Option require HSR Filings, then AbbVie may provide the License Option Exercise Notice for the License Option to Anima prior to the end of the applicable License Option Period, which notice shall include AbbVie's irrevocable binding commitment to complete the exercise of the License Option, subject only to HSR Clearance and the terms of this Section 2.11, and the applicable License Option Period shall automatically be extended for so long as is necessary for AbbVie to obtain HSR Clearance (the \"HSR Extension Period\").", "": "" }, { "Text": "2.11.2 In connection with the Parties' activities under this Section 2.11 (HSR), AbbVie and Anima shall each use Commercially Reasonable Efforts to resolve as promptly as practicable any objections that may be asserted by the FTC or the DOJ with respect to the transactions notified in the HSR Filings. Nothing in this Section 2.11 (HSR) or otherwise in this Agreement shall require either Party to (a) offer, accept or agree to sell, divest (including through a license or a reversion of licensed or assigned rights), hold separate, transfer, or dispose of any assets, operations, rights, product lines, or businesses, or interests therein, of itself or any of its Affiliates (or consent to any of the foregoing actions), (b) offer, accept or agree to any restraint, prohibition or limitation on the ownership, operation, or conduct of all or any portion of the businesses or assets of itself or any of its Affiliates in any part of the world, or (c) litigate or otherwise formally oppose any determination (whether judicial or administrative in nature) by a Governmental Authority seeking to impose any of the restrictions referenced in clause (a) or (b) above; provided that neither Party shall agree to or effectuate any remedy without the prior written consent of the other Party.", "": "" }, { "Text": "2.11.3 AbbVie shall be responsible for all filing fees in connection with the filing of submissions to the FTC and DOJ under the HSR Act, and each Party shall be responsible for its costs and expenses, including attorneys' fees, incurred by it in preparing submissions or responses or responding to any Second Request or other action by the FTC or DOJ under the HSR Act. If HSR Filings are required, then each Party shall use Commercially Reasonable Efforts to prepare and file its respective HSR Filing as promptly as is practicable and advisable, with the goal of filing the HSR Filings within twenty (20) Business Days after Anima receiving the License Option Exercise Notice for the applicable License Option. In connection with obtaining HSR Clearance, each of AbbVie and Anima shall (a) cooperate with each other in connection with any investigation or other inquiry relating to an HSR Filing and the transactions contemplated by this Agreement; (b) keep the other Party or its counsel informed of any material communication received from or given to the FTC or DOJ relating to the HSR Filings and the transactions contemplated by this Agreement (and provide a copy to the other Party if such material communication is in writing); and (c) permit the other Party or its counsel to review in advance, and in good faith consider the views of the other Party or its counsel concerning, any submission, filing, or communication (and documents submitted therewith) intended to be given to the FTC or DOJ.", "": "" }, { "Text": "2.11.4 Tolling of Obligations. If the exercise by AbbVie of a License Option under Section 2.9.3 (Exercise of License Option) requires the making of filings under the HSR Act, then all rights and obligations related to the exercise of the License Option (including payment of any License Option Exercise Fee) and the granting of the AbbVie License shall be tolled until the HSR Clearance.", "": "" }, { "Text": "2.12 No Exercise of License Option. On a Target Program Slot-by-Target Program Slot basis, if AbbVie does not exercise a License Option with respect to a Target Program Slot in accordance with Section 2.9.3 (Exercise of License Option) during the applicable License Option Period (including, for clarity, if not extended pursuant Section 2.9.2 (License Option Period Extension)), then, upon the earlier of (a) the expiration of the License Option Period with respect to such Target Program Slot and (b) AbbVie's written notice to Anima that it declines to exercise a License Option with respect to such Target Program Slot, AbbVie shall have no further license under this Agreement with respect to the Licensed IP, Anima Background Patents, Anima Background Know-How, and Anima Improvements with respect to such Target Program Slot, and the Collaboration Target corresponding to such Target Program Slot shall be deemed to no longer be a Collaboration Target under this Agreement.", "": "" }, { "Text": "ARTICLE 3 MANAGEMENT OF THE COLLABORATION", "": "" }, { "Text": "3.1 Joint Governance Committee. Within fifteen (15) days after the Effective Date, the Parties shall establish a joint governance committee (the \"JGC\") to serve as the oversight and decision-making body for the activities to be conducted by the Parties pursuant to this Agreement, as more fully described in this ARTICLE 3 (Management of the Collaboration). The JGC shall consist of three (3) representatives from each Party, each of whom shall be an employee of such Party and shall have the requisite experience and seniority to enable such person to make decisions on behalf of the Parties with respect to the issues falling within the jurisdiction of the JGC. From time to time, each Party may substitute one (1) or more of its employee representatives to the JGC on written notice to the other Party. The JGC will be co-chaired by a JGC representative of Anima and a JGC representative of AbbVie. From time to time, either Party may change the employee representative who will serve as such Party's JGC co-chairperson on written notice to the other Party.", "": "" }, { "Text": "3.2 Responsibilities. The JGC shall perform the following functions, subject to the final decision-making authority of the respective Parties as set forth in Section 3.5 (Decision-Making):", "": "" }, { "Text": "(a) review and decide whether to approve (and if so decided, approve in writing) each proposed Collaboration Plan and any proposed amendment to a Collaboration Plan;", "": "" }, { "Text": "(b) review the progress reports submitted by Anima under Section 2.7.4 (Information and Reports);", "": "" }, { "Text": "(c) serve as an initial forum for discussion of any issues or disputes arising from the conduct of the activities under each Collaboration Plan;", "": "" }, { "Text": "(d) review and discuss any delay, as described in Section 2.7.3 (Timeline; Delays);", "": "" }, { "Text": "(e) determine the end date of the Collaboration Term with respect to a Target Program Slot;", "": "" }, { "Text": "(f) form working groups, subcommittees, or directed teams as the JGC deems necessary to oversee particular projects or activities or otherwise to achieve the objective and intent of this Agreement (each, a \"Subcommittee\", and the JGC and any Subcommittee, a \"Committee\");", "": "" }, { "Text": "(g) review and resolve any reports, recommendations, or disputes of any Subcommittee;", "": "" }, { "Text": "(h) assign responsibilities that may fall within the purview of more than one (1) Subcommittee to a particular Subcommittee; and", "": "" }, { "Text": "(i) perform such other responsibilities as may be assigned to the JGC pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time.", "": "" }, { "Text": "For clarity, the JGC shall not have any authority beyond the specific matters set forth in this Section 3.2 (Responsibilities) and, further, the JGC's authority shall be subject to the limitations set forth in Section 3.5.3 (Escalation to the Parties; Limitations on Authority).", "": "" }, { "Text": "3.3 Meetings and Minutes. The JGC shall meet quarterly or as otherwise agreed to by the Parties (including on an ad hoc basis), but in any event shall have at least two (2) in-person or video conference meetings per Calendar Year. Each other Committee shall meet quarterly, or more frequently as agreed to by the Parties, by in-person or video conference meetings. The location of any such in-person meetings shall alternate between locations designated by Anima and locations designated by AbbVie. The co-chairpersons of the Committee shall be responsible for calling meetings on no less than ten (10) Business Days' notice. Each Party shall make all proposals for agenda items and shall provide all appropriate information with respect to such proposed items at least five (5) Business Days in advance of the applicable meeting; provided that under exigent circumstances requiring input by a Committee, a Party may provide its agenda items to the other Party within a shorter period of time in advance of the meeting, or may propose that there not be a specific agenda for a particular meeting, so long as the other Party consents to such later addition of such agenda items or the absence of a specific agenda for such meeting, such consent not to be unreasonably withheld, conditioned, or delayed. The co-chairpersons of each Committee shall prepare and circulate for review and approval of the Parties minutes of each meeting of such Committee within thirty (30) days after the meeting. The Parties shall agree on the minutes of each meeting promptly, but in no event later than the next meeting of the relevant Committee.", "": "" }, { "Text": "3.4 Procedural Rules. The JGC shall have the right to adopt such standing rules as shall be necessary for its work and the work of each Subcommittee, to the extent that such rules are not inconsistent with this Agreement. A quorum of a Committee shall exist whenever there is present at a meeting at least one (1) representative appointed by each Party. Representatives of the Parties on a Committee may attend a meeting either in-person or by telephone or video conference. Representation by proxy shall be allowed. Each Committee shall take action by consensus of the representatives present at a meeting at which a quorum exists, with each Party having a single vote irrespective of the number of representatives of such Party in attendance, or by a written resolution signed by at least one (1) representative appointed by each Party. Employees or consultants of either Party who are not representatives of the Parties on a Committee may attend meetings of such Committee; provided that such attendees (a) shall not vote or otherwise participate in the decision-making process of the JGC and (b) are bound by obligations of confidentiality and non-disclosure equivalent to those set forth in ARTICLE 10 (Confidentiality).", "": "" }, { "Text": "3.5 Decision-Making.", "": "" }, { "Text": "3.5.1 Escalation to JGC. Except as otherwise provided herein, all decisions of a Committee shall be made by consensus, with all of a Party's voting members collectively having one (1) vote. Decisions of a Committee shall be made by unanimous vote. If a Subcommittee is incapable of reaching unanimous agreement on a matter before it within ten (10) Business Days (or such other time period as mutually agreed by the Parties), then the matter shall be referred to the JGC for resolution. If the JGC is incapable of reaching unanimous agreement on a matter before it within ten (10) Business Days (or such other time period as mutually agreed by the Parties), then the matter shall be resolved in accordance with Section 3.5.2 (Escalation to the Executive Officers).", "": "" }, { "Text": "3.5.2 Escalation to the Executive Officers. If the JGC cannot agree on a matter within ten (10) Business Days (or such other time period as mutually agreed by the Parties) after it has met and attempted to reach such decision, then either Party may, by written notice to the other, refer such issue to the Executive Officers for resolution. The Parties' respective Executive Officers shall meet within ten (10) Business Days (or such other time period as mutually agreed by the Parties) after such matter is referred to them and shall negotiate in good faith to resolve the matter.", "": "" }, { "Text": "3.5.3 Escalation to the Parties; Limitations on Authority. If the Executive Officers are unable to resolve the matter within ten (10) Business Days after the matter is referred to them (or such other time period as mutually agreed by the Parties), then:", "": "" }, { "Text": "(a) Neither Party will have final decision-making authority with respect to the approval of an initial Collaboration Plan with respect to any Additional Target Program Slot or the approval of an amendment to any existing Collaboration Plan in a Target Program Slot; provided that, notwithstanding any provision to the contrary in this Agreement, Anima will not unreasonably withhold, delay, or condition its approval of a proposed new Collaboration Plan for an Additional Target Program Slot or a proposed amendment to an existing Collaboration Plan in the applicable Target Program Slot, if such new Collaboration Plan or such as-amended Collaboration Plan, as applicable:", "": "" }, { "Text": "(i) includes at least those elements and approximate timelines set forth in an existing Collaboration Plan that are scientifically applicable to the activities under such new or as-amended Collaboration Plan;", "": "" }, { "Text": "(ii) is substantially similar in scientific detail and rigor to an existing Collaboration Plan; and", "": "" }, { "Text": "(iii) solely with respect to any proposed amendment to an existing Collaboration Plan: (A) does not increase Anima's overall expenditure for the applicable Target Program Slot, as determined by Anima and as compared to the original Collaboration Plan for such Target Program Slot, by more than Five Hundred Thousand Dollars ($500,000) in the aggregate for such Target Program Slot or (B) does not increase Anima's overall expenditure for the applicable Target Program Slot, as determined by Anima and as compared to the original Collaboration Plan for such Target Program Slot, by more than One Million Two Hundred Thousand Dollars ($1,200,000) in the aggregate for such Target Program Slot if AbbVie agrees to reimburse Anima for any such excess costs above Five Hundred Thousand Dollars ($500,000) and below One Million Two Hundred Thousand Dollars ($1,200,000).", "": "" }, { "Text": "(b) AbbVie will have final decision-making authority with respect to any JGC determination of the end date of a Collaboration Term.", "": "" }, { "Text": "(c) Except as provided in clauses (a)-(b), neither Party shall have final decision-making authority with respect to the applicable matter, the status quo will prevail, and either Party may propose to resolve the applicable matter by an ADR proceeding pursuant to the procedures set forth in Schedule 14.2.2 (ADR Procedures).", "": "" }, { "Text": "Any decision made by the Executive Officers in accordance with Section 3.5.2 (Escalation to the Executive Officers) or by a Party in accordance with this Section 3.5.3 (Escalation to the Parties; Limitations on Authority) shall be considered a decision made by the JGC.", "": "" }, { "Text": "3.6 Limits on Decision-Making. Notwithstanding anything to the contrary in this Agreement, including Section 3.5 (Decision-Making), in no event shall either Party alone have the power or authority to:", "": "" }, { "Text": "(a) make any determination that such Party has fulfilled its obligations under this Agreement or that the other Party has breached this Agreement;", "": "" }, { "Text": "(b) make any decision that is expressly stated to require the mutual agreement of the Parties or approval of the other Party; or", "": "" }, { "Text": "(c) impose any requirement on the other Party to perform any act that the other Party reasonably believes to be inconsistent with any applicable Law.", "": "" }, { "Text": "3.7 Alliance Managers. Promptly after the formation of the JGC, each Party shall appoint an employee (who may not be a then-current member of the JGC) to act as alliance manager for such Party (each, an \"Alliance Manager\"). Each Alliance Manager shall thereafter be permitted to attend meetings of the JGC as a nonvoting observer. The Alliance Managers shall be the primary point of contact for the Parties regarding the activities contemplated by this Agreement. The Alliance Managers shall also be responsible for assisting the JGC in performing its oversight responsibilities. The name and contact information for each Party's Alliance Manager, as well as any replacement chosen by such Party, in its sole discretion, from time to time, shall be promptly provided to the other Party in accordance with Section 14.5 (Notices). Any disagreement between the Alliance Managers of AbbVie and Anima shall be referred to the JGC for resolution.", "": "" }, { "Text": "3.8 Discontinuation of Committees. Unless otherwise agreed by the Parties, on a Target Program Slot-by-Target Program Slot basis:", "": "" }, { "Text": "3.8.1 Upon AbbVie's exercise of the License Option with respect to a Target Program Slot, no Committee shall have any decision-making role with respect to the applicable Target Program Slot, except that the JGC may determine (a) the end date of the Collaboration Term with respect to such Target Program Slot provided that AbbVie will have final decision-making authority under Section 3.5 (Decision-Making) with respect to such decision and (b) any amendments to the Collaboration Plan for such Target Program Slot as and to the extent such amendment affects Anima.", "": "" }, { "Text": "3.8.2 Upon the end of the Collaboration Term with respect to a Target Program Slot, the role of any Committee with respect to the Target Program Slot shall be automatically disbanded and the Alliance Manager roles with respect to such Target Program Slot shall be automatically terminated, and for clarity, following the applicable License Option Effective Date, AbbVie will have sole and exclusive control over, and as between the Parties, sole and exclusive decision-making authority with respect to, such Target Program Slot under this Agreement.", "": "" }, { "Text": "3.9 Interactions Between a Committee and Internal Teams. The Parties recognize that each Party possesses an internal structure (including various committees, teams, and review boards) that will be involved in administering such Party's activities under this Agreement. Nothing contained in this ARTICLE 3 (Management of the Collaboration) shall prevent a Party from making routine day-to-day decisions relating to the conduct of those activities for which it has a performance or other obligations hereunder, in each case in a manner consistent with the then-current applicable Collaboration Plan and the terms and conditions of this Agreement.", "": "" }, { "Text": "3.10 Subcommittees. Subject to the terms of this Agreement, each Subcommittee shall be constituted and shall operate as the JGC determines; provided that each Subcommittee shall have equal representation from each Party, unless otherwise mutually agreed. Each Subcommittee and its activities shall be subject to the oversight, review, and approval of, and shall report to, the JGC. In no event shall the authority of the Subcommittee exceed that specified for the JGC.", "": "" }, { "Text": "3.11 Expenses. Each Party shall be responsible for all travel and related costs and expenses for its members and other representatives to attend meetings of, and otherwise participate on, a Committee.", "": "" }, { "Text": "3.12 Authority. Each Party will retain the rights, powers, and discretion granted to it under this Agreement and no such rights, powers, or discretion will be delegated to or vested in a Committee unless such delegation or vesting of rights is expressly provided for in this Agreement or the Parties expressly so agree in writing.", "": "" }, { "Text": "ARTICLE 4 GRANT OF LICENSES", "": "" }, { "Text": "4.1 Licenses to AbbVie.", "": "" }, { "Text": "4.1.1 Commercial Licenses. Subject to the terms and conditions of this Agreement, on a Target Program Slot-by-Target Program Slot basis, upon AbbVie's exercise of a License Option with respect to a Target Program Slot in accordance with Section 2.9.3 (Exercise of License Option), and subject to Section 2.11.4 (Tolling of Obligations), Anima (on behalf of itself and its Affiliates) hereby grants to AbbVie and its Affiliates: (a) an exclusive (even as to Anima and its Affiliates), non-transferable (except in accordance with Section 14.3 (Assignment)), sublicensable (subject to Section 4.2 (Sublicensing Rights)) license (or sublicense as applicable) under the Licensed IP to (i) Exploit ADC Royalty-Bearing Compounds and Royalty-Bearing Products containing ADC Royalty-Bearing Compounds in the Field in the Territory and (ii) use the Licensed IP, including the License Option Exercise Data Package and any Know-How set forth therein, for any purpose in the Field in the Territory, including to generate, research, and develop molecules, compounds, products, or other therapeutic agents (including Non-ADC Royalty-Bearing Compounds) and (b) a non-exclusive, non-transferable (except in accordance with Section 14.3 (Assignment)), sublicensable (subject to Section 4.2 (Sublicensing Rights)) license (or sublicense as applicable) under the Anima Background Patents, Anima Background Know-How, and Anima Improvements, in each case solely to the extent necessary for AbbVie and its Affiliates to Exploit Royalty-Bearing Compounds and Royalty-Bearing Products in the Field in the Territory (such licenses, the \"AbbVie License\"). Notwithstanding any provision to the contrary in this Agreement, the AbbVie License does not permit (A) AbbVie to use the (x) Anima Background Know-How that is Anima Platform Technology, or (y) Anima Improvements to the extent they constitute or claim improvements to Anima Platform Technology, or (z) Anima Background Patents to the extent they claim Anima Platform Technology, in each case ((x)-(z)) for the discovery or research of any molecule, compound, product, or other therapeutic agent, or (B) AbbVie to Exploit an active ingredient in a Royalty-Bearing Product other than a Royalty-Bearing Compound.", "": "" }, { "Text": "4.1.2 Collaboration Activities License. Subject to the terms and conditions of this Agreement, Anima (on behalf of itself and its Affiliates), hereby grants to AbbVie and its Affiliates during the Collaboration Term, a non-exclusive, royalty-free, non-transferable (except in accordance with Section 14.3 (Assignment)), sublicensable (subject to Section 4.2 (Sublicensing Rights)) license (or sublicense, as applicable) under the Licensed IP, Anima Background Patents, Anima Background Know-How, and Anima Improvements to perform the activities allocated to AbbVie under any Collaboration Plan (the \"AbbVie Collaboration Activities License\"), which license, for clarity, does not permit AbbVie to use the Anima Background Know-How, Anima Background Patents, or Anima Improvements for discovery or research of any molecule, compound, product, or other therapeutic agent.", "": "" }, { "Text": "4.2 Sublicensing Rights. AbbVie shall have the right to grant and authorize sublicenses under the rights granted to it under Section 4.1 (Licenses to AbbVie) to any Third Parties through multiple tiers (each such Third Party, a \"Sublicensee\"). Each Sublicensee shall be subject to a written agreement that is consistent with all applicable requirements of this Agreement. AbbVie shall contractually require its Sublicensees to comply with the applicable terms and conditions of this Agreement and shall remain directly responsible for fulfillment of all of its obligations under this Agreement, regardless of whether any such obligation is sublicensed to any Third Party.", "": "" }, { "Text": "4.3 UPenn Rights. Notwithstanding any provision to the contrary in this Agreement, the AbbVie License and the AbbVie Collaboration Activities License shall not include a license or sublicense under the UPenn Technology and Anima shall not, and shall ensure that its Affiliates and subcontractors do not, disclose any UPenn Technology to AbbVie or to any of AbbVie's Affiliates or Sublicensees. The Parties will act in good faith toward the engagement of Marshal, Gerstein & Borun LLP or, if Marshal, Gerstein & Borun LLP is not amenable to being so engaged, another independent Third Party legal counsel with expertise in biotechnology licensing and collaborations and reasonably acceptable to AbbVie and Anima, in either case (as applicable), within a reasonable time following the Effective Date to review this Agreement for the sole purpose of confirming to UPenn that this Agreement does not include a license or sublicense under the UPenn Technology, provided that (a) as between the Parties, Anima will be solely responsible for the fees of such Third Party legal counsel, (b) such Third Party legal counsel will act in the capacity of a neutral Third Party gatekeeper and will not represent any of AbbVie, Anima, or UPenn as its client in such review, and (c) the engagement of such Third Party legal counsel for the above purpose will be subject a gatekeeping or other similar written agreement, which written agreement shall (i) include obligations of confidentiality and non-use with respect to the Confidential Information of AbbVie that are no less restrictive than the obligations of confidentiality and non-use of Anima pursuant to ARTICLE 10 (Confidentiality), (ii) provide that such Third Party legal counsel shall in no event disclose this Agreement or any term thereof, or otherwise provide any information with respect to the transactions contemplated under this Agreement, to UPenn other than a confirmation that this Agreement does not include a license or sublicense under the UPenn Technology, and (iii) provide that such review will be completed within a reasonable time, not to exceed thirty (30) days following signing of the applicable written agreement.", "": "" }, { "Text": "4.4 No Other Rights. Except as otherwise expressly provided in this Agreement, under no circumstances shall a Party, as a result of this Agreement, obtain any ownership interest, license right, or other right in any Know-How, Patent Rights, or other intellectual property rights of the other Party or any of its Affiliates, including items owned, controlled, developed, or acquired by the other Party or any of its Affiliates, or provided by the other Party to the first Party at any time pursuant to this Agreement.", "": "" }, { "Text": "4.5 Confirmatory Patent License. Anima shall, if requested to do so by AbbVie, immediately enter into confirmatory license agreements in such form as may be reasonably requested by AbbVie for purposes of recording the licenses granted under this Agreement with such patent offices in the Territory as AbbVie considers appropriate. Until the execution of any such confirmatory licenses, so far as may be legally possible, Anima and AbbVie shall have the same rights in respect of the applicable intellectual property and be under the same obligations to each other in all respects as if the said confirmatory licenses had been executed.", "": "" }, { "Text": "4.6 In-License Agreements. On a Target Program Slot-by-Target Program Slot basis, if at any time during the applicable In-License Agreement Notification Period Anima or any of its Affiliates enters into an agreement with a Third Party pursuant to which Anima or its Affiliate in-licenses or otherwise acquires rights that, if owned by Anima, would be included within the Anima Background Know-How or Anima Background Patents (\"Proposed In-Licensed Rights\"), then Anima shall notify AbbVie thereof and provide AbbVie with a copy of such Third Party agreement promptly following execution of such agreement (each such agreement, a \"Proposed In-License Agreement\"), provided that Anima shall have the right to redact any confidential and commercially sensitive information in such In-License Agreements that is not relevant for AbbVie to assess its rights and obligations as a sublicensee thereunder. If AbbVie notifies Anima in writing that, subject to Section 7.18 (Financial Obligations under In-License Agreements), AbbVie wishes to be bound by or assume the rights and obligations of a Proposed In-License Agreement as they apply to AbbVie as a sublicensee under this Agreement, then: (a) the applicable Proposed In-Licensed Rights will automatically be included in the Anima Background Know-How or Anima Background Patents (as applicable) hereunder; (b) following the exercise of the applicable License Option for such Target Program Slot (if not already exercised), AbbVie agrees to abide by all applicable terms and conditions of such Proposed In-License Agreement that Anima has disclosed to AbbVie as such terms and conditions relate to AbbVie as a sublicensee under this Agreement; and (c) such Proposed In-License Agreement shall be an \"In-License Agreement\" hereunder. Otherwise, notwithstanding any provision to the contrary in this Agreement, the Proposed In-Licensed Rights will not be included within the Anima Background Know-How or Anima Background Patents and AbbVie will not be a sublicensee under such Proposed In-License Agreement. For the purposes of this Agreement, \"In-License Agreement Notification Period\" shall mean, with respect to a Target Program Slot, (i) the duration of the License Option Period with respect to such Target Program Slot and (ii) solely if AbbVie exercises the License Option with respect to such Target Program Slot during the applicable License Option Period, the duration of the Term.", "": "" }, { "Text": "4.7 Rights in Bankruptcy.", "": "" }, { "Text": "4.7.1 Section 365(n) of the Bankruptcy Code. All rights and licenses granted under or pursuant to this Agreement by Anima to AbbVie, including those set forth in Section 4.1 (Licenses to AbbVie) (collectively, the \"Bankruptcy Code Intellectual Property\") are and shall otherwise be deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code, licenses of rights to \"intellectual property\" as defined under Section 101 of the U.S. Bankruptcy Code. The Parties agree that AbbVie shall retain and may fully exercise all of its rights and elections under the U.S. Bankruptcy Code and any foreign counterpart thereto. The Parties acknowledge and agree that only the payments made under Section 7.8 (Royalties) shall constitute royalties within the meaning of Section 365(n) of the U.S. Bankruptcy Code or any analogous provisions in any other country or jurisdiction.", "": "" }, { "Text": "4.7.2 Rights of Non-Debtor Party in Bankruptcy. If a bankruptcy proceeding is commenced by or against Anima under the U.S. Bankruptcy Code or any analogous provisions in any other country or jurisdiction, then AbbVie shall be entitled to a complete duplicate of (or complete access to, as appropriate) any Bankruptcy Code Intellectual Property and all embodiments of such Bankruptcy Code Intellectual Property, which, if not already in AbbVie's possession, shall be delivered to AbbVie within five (5) Business Days of such request; provided that Anima shall excused from its obligation to deliver the Bankruptcy Code Intellectual Property to the extent Anima continues to perform all of its obligations under this Agreement and the Agreement has not been rejected pursuant to the Bankruptcy Code or any analogous provision in any other country or jurisdiction.", "": "" }, { "Text": "ARTICLE 5 POST-LICENSE OPTION EXERCISE ACTIVITIES", "": "" }, { "Text": "5.1 Anima Transition Obligation Upon License Option Exercise. On a Target Program Slot-by-Target Program Slot basis, upon AbbVie's request following the exercise of a License Option by AbbVie with respect to a Target Program Slot, without additional consideration to Anima:", "": "" }, { "Text": "5.1.1 within thirty (30) days after the applicable License Option Effective Date, Anima shall transfer to AbbVie: (a) copies of all data, reports, records, materials, and other information within the Licensed IP and (b) the file wrappers and other documents and materials relating to the prosecution, defense, maintenance, validity, and enforceability of the Anima Collaboration Patents;", "": "" }, { "Text": "5.1.2 without limiting Section 5.1.1(b), Anima shall assist and cooperate with AbbVie, as AbbVie may reasonably request, in the transition of the prosecution, maintenance, enforcement, and defense of the applicable Anima Collaboration Patents; and", "": "" }, { "Text": "5.1.3 Anima shall duly execute and deliver or cause to be duly executed and delivered, such instruments and shall do and cause to be done such acts and things, including the filing of such assignments, agreements, documents, and instruments, as may be necessary under or as AbbVie may reasonably request in connection with or to carry out more effectively the purpose of, or to better assure and confirm unto AbbVie its rights to Exploit the applicable Royalty-Bearing Compounds and Royalty-Bearing Products in accordance with, this Agreement.", "": "" }, { "Text": "5.2 AbbVie Development and Commercialization. On a Target Program Slot-by-Target Program Slot basis, following the applicable License Option Effective Date with respect to such Target Program Slot, other than any remaining activities allocated to Anima under the applicable Collaboration Plan or any applicable Post-License Option Exercise Activities, as between the Parties, AbbVie shall have the sole right to conduct (and have sole and exclusive decision-making authority with respect to) all Development, Manufacturing, and Commercialization activities in connection with the applicable Royalty-Bearing Compounds and the Royalty-Bearing Products with respect to such Target Program Slot in the Field in the Territory, which activities shall be conducted in accordance with this Agreement, and AbbVie shall be responsible for all costs and expenses incurred by or on behalf of AbbVie with respect to such activities.", "": "" }, { "Text": "5.3 AbbVie Diligence Obligation. Following initiation of IND-Enabling Studies for the first Royalty-Bearing Product under this Agreement, AbbVie shall use Commercially Reasonable Efforts to Develop and obtain Regulatory Approval for such first Royalty-Bearing Product in the Field in the United States and three (3) Major European Markets. Notwithstanding any provision to the contrary set forth in this Agreement, if Anima terminates this Agreement with respect to such Royalty-Bearing Product in accordance with Section 13.2.1 (Termination for Cause) as a result of a breach of AbbVie's diligence obligations under this Section 5.3 (AbbVie Diligence Obligation), then such termination shall be Anima's sole and exclusive remedy with respect to such breach.", "": "" }, { "Text": "ARTICLE 6 GENERAL PROVISIONS RELATING TO ACTIVITIES", "": "" }, { "Text": "6.1 Compliance. All activities to be conducted by a Party under this Agreement shall be conducted in compliance with applicable Laws, including all applicable good laboratory practice requirements and good clinical practice requirements.", "": "" }, { "Text": "6.2 Regulatory Activities.", "": "" }, { "Text": "6.2.1 From and after the exercise by AbbVie of a License Option, AbbVie shall, as between the Parties, have the sole right to prepare, obtain, and maintain all INDs, Regulatory Approval Applications (including the setting of the overall regulatory strategy therefor), other Regulatory Approvals, and other submissions for, and to conduct communications with the Regulatory Authorities and Governmental Authorities in the Territory for, the applicable Royalty-Bearing Products, including, as between the Parties, the sole and exclusive final decision-making authority with respect to each of the foregoing. Anima shall support AbbVie, as may be reasonably requested by AbbVie, in preparing and filing INDs and obtaining Regulatory Approvals for such Royalty-Bearing Products and in the activities in support thereof, including providing all documents or other materials in the possession or control of Anima or any of its Affiliates as may be necessary or useful for AbbVie or any of its Affiliates or Sublicensees to prepare and file INDs and obtain Regulatory Approvals for such Royalty-Bearing Products.", "": "" }, { "Text": "6.2.2 From and after the exercise by AbbVie of a License Option, all Regulatory Filings (including all Regulatory Approvals) in the Territory relating to the applicable Royalty-Bearing Products shall be owned by, and shall be the sole property and held in the name of, AbbVie or its designated Affiliate, Sublicensee, or designee.", "": "" }, { "Text": "6.3 Performance by Affiliates and Sublicensees. Notwithstanding any provision to the contrary set forth in this Agreement, AbbVie shall have the right to perform any or all of its obligations and exercise any or all of its rights under this Agreement through any Affiliate or Sublicensee (subject to Section 4.2 (Sublicensing Rights)); provided that AbbVie shall remain directly responsible for fulfillment of all of its obligations under this Agreement.", "": "" }, { "Text": "6.4 Subcontracting.", "": "" }, { "Text": "6.4.1 AbbVie shall have the right to engage Third Party subcontractors (including by appointing one (1) or more contract sales forces, co-promotion partners, or Distributors) to perform any of its activities under this Agreement.", "": "" }, { "Text": "6.4.2 Anima and its Affiliates shall have the right to subcontract its activities under this Agreement to any Affiliate or Third Party subcontractor to the extent expressly provided for in a Collaboration Plan or otherwise with the prior written approval of AbbVie, such approval not to be unreasonably withheld; provided that Anima shall remain directly responsible for fulfillment of all of its obligations under this Agreement. Any Affiliate or Third Party subcontractor engaged by Anima to perform Anima's obligations set forth in this Agreement shall meet (a) any qualification requirements provided by AbbVie and (b) the qualifications typically required by Anima for the performance of work similar in scope and complexity to the subcontracted activity.", "": "" }, { "Text": "6.5 Records and Audits. Each Party shall, and shall require its Affiliates and permitted subcontractors to, maintain materially complete, current, and accurate hard and electronic (as applicable) copies of records of all work conducted pursuant to its Development, Manufacturing, and Commercialization activities under this Agreement, and all results, data, developments, and Know-How made in conducting such activities. Such records shall accurately reflect all such work done and results achieved in sufficient detail to verify compliance with such Party's obligations under this Agreement and shall be in good scientific manner appropriate for applicable patent and regulatory purposes. With respect to Anima, such books and records shall record only its Development activities performed pursuant to this Agreement and shall not include or be commingled with records of Development activities outside the scope of this Agreement or include any financial records. AbbVie shall have the right, during normal business hours and upon reasonable notice but not more frequently than twice per Calendar Year, to inspect and copy all records of Anima maintained pursuant to this Section 6.5 (Records and Audits); provided that AbbVie shall maintain any Confidential Information of Anima in such records in confidence in accordance with ARTICLE 10 (Confidentiality).", "": "" }, { "Text": "ARTICLE 7 UPFRONT FEE; MILESTONES AND ROYALTIES; PAYMENTS", "": "" }, { "Text": "7.1 Upfront Fee. No later than ten (10) days following the Effective Date, AbbVie shall pay Anima a one-time non-refundable, non-creditable upfront payment of Forty-Two Million Dollars ($42,000,000).", "": "" }, { "Text": "7.2 Additional Target Program Fee. On an Additional Target Program Slot-by-Additional Target Program Slot basis, AbbVie shall pay to Anima a one-time non-refundable, non creditable payment corresponding to the period during which the Additional Target Program Slot Designation Date occurs, as set forth in the table below (the \"Additional Target Program Fee\") within thirty (30) days after the later of (a) Anima's receipt of the Additional Target Program Notice for such Additional Target Program Slot pursuant to Section 2.2.2 (Additional Target Program Slots) and (b) the JGC's approval of a Collaboration Plan for such Additional Target Program Slot (the \"Additional Target Program Slot Designation Date\").", "": "" }, { "Text": "Time Period During Which Additional Target Program Slot Designation Date Occurs", "": "" }, { "Text": "Before or on two- (2-) year anniversary of the Effective Date", "": "" }, { "Text": "After two- (2-) year anniversary of the Effective Date and before or on three- (3-) year anniversary of the Effective Date", "": "" }, { "Text": "After three- (3-) year anniversary of the Effective Date and before or on four- (4-) year anniversary of the Effective Date", "": "" }, { "Text": "After four- (4-) year anniversary of the Effective Date", "": "" }, { "Text": "7.3 Collaboration Target Substitution Fee. Within thirty (30) days of Anima's receipt of a Collaboration Target Substitution Notice for each Collaboration Target substitution pursuant to Section 2.3 (Collaboration Target Substitution):", "": "" }, { "Text": "7.3.1 Solely if Anima receives the applicable Collaboration Target Substitution Notice prior to AbbVie's payment of the License Option Period Extension Fee for the replaced Collaboration Target, then AbbVie shall pay to Anima the non-refundable, non-creditable fee corresponding to the period during which such substitution occurs, as set forth in the table below, provided, however, that if Anima has not at that time performed all activities required to be performed by Anima as of such time under the applicable Collaboration Plan (as may be amended by the JGC from time to time), then AbbVie shall be entitled to deduct the budgeted cost of such unperformed activities set forth on Exhibit B-2 from the applicable Collaboration Target Substitution Fee:", "": "" }, { "Text": "As of the date of the applicable Collaboration Target Substitution Notice, number of Months following (a) for Collaboration Targets Selected as of the Effective Date, the Effective Date, or (b) for any Other Collaboration Target, the Commencement of Activities with respect to such Collaboration Target under the Applicable Collaboration Plan", "": "" }, { "Text": "Less than three (3) months", "": "" }, { "Text": "Three (3) – six (6) months", "": "" }, { "Text": "Six (6) – nine (9) months", "": "" }, { "Text": "Nine (9) – twelve (12) months", "": "" }, { "Text": "Twelve (12) – fifteen (15) months", "": "" }, { "Text": "More than fifteen (15) months", "": "" }, { "Text": "7.3.2 Solely if Anima receives the applicable Collaboration Target Substitution Notice after (a) AbbVie had paid a License Option Period Extension Fee for the replaced Collaboration Target and (b) Anima has completed lead generation activities under the applicable Collaboration Plan (as may be amended by the JGC from time to time) with respect to the replaced Collaboration Target, then AbbVie shall pay to Anima the non-refundable, non-creditable fee corresponding to the period during which such substitution occurs, as set forth in the table below, provided, however, that if Anima has not at that time performed all activities required to be performed by Anima as of such time under the applicable Collaboration Plan, then AbbVie will be entitled to deduct the budgeted cost of such unperformed activities as set forth on Exhibit B-2 from the applicable Collaboration Target Substitution Fee:", "": "" }, { "Text": "As of the date of the applicable Collaboration Target Substitution Notice, number of Months following Completion of Lead Generation Activities under Applicable Collaboration Plan", "": "" }, { "Text": "Less than three (3) months", "": "" }, { "Text": "Three (3) – six (6) months", "": "" }, { "Text": "Six (6) – nine (9) months", "": "" }, { "Text": "Nine (9) – twelve (12) months", "": "" }, { "Text": "Twelve (12) – fifteen (15) months", "": "" }, { "Text": "More than fifteen (15) months", "": "" }, { "Text": "7.3.3 Any fee payable under the foregoing Section 7.3.1 (Collaboration Target Substitution Fee) or Section 7.3.2 (Collaboration Target Substitution Fee) is a \"Collaboration Target Substitution Fee.\" For clarity, AbbVie will have no obligation to pay a Collaboration Target Substitution Fee or make any other payment under this Agreement in connection with any substitution of a Collaboration Target if Anima receives the applicable Collaboration Target Substitution Notice (a) after AbbVie has paid a License Option Period Extension Fee for the applicable replaced Collaboration Target and (b) before Anima has completed lead generation activities under the applicable Collaboration Plan (as may be amended by the JGC from time to time) with respect to the applicable replaced Collaboration Target. Further, for clarity, AbbVie will have no obligation to pay a Collaboration Target Substitution Fee in the event that AbbVie terminates this Agreement with respect to a certain existing Target Program Slot and selects an Additional Target Program Slot.", "": "" }, { "Text": "7.4 License Option Period Extension Fee. On a Target Program Slot-by-Target Program Slot basis, AbbVie may extend the end date of the License Option Period with respect to a Target Program Slot by paying to Anima a non-refundable, non-creditable license option period extension fee of (a) for a Target Program Slot that is not an Additional Target Program Slot, Ten Million Dollars ($10,000,000) or (b) for an Additional Target Program Slot, the fee set forth in the table below corresponding to the period during which AbbVie pays such fee, in each case ((a) and (b)) with respect to the then-current Collaboration Target for the Target Program Slot (each such fee, a \"License Option Period Extension Fee\"). For clarity, the License Option Period Extension Fee will be payable for any replaced Collaboration Target in addition to the Collaboration Target Substitution Fee for the replaced Collaboration Target.", "": "" }, { "Text": "Time Period During Which AbbVie Pays the License Option Period Extension Fee", "": "" }, { "Text": "Before or on two- (2-) year anniversary of the Effective Date", "": "" }, { "Text": "After two- (2-) year anniversary of the Effective Date and before or on three- (3-) year anniversary of the Effective Date", "": "" }, { "Text": "After three- (3-) year anniversary of the Effective Date and before or on four- (4-) year anniversary of the Effective Date", "": "" }, { "Text": "After four- (4-) year anniversary of the Effective Date", "": "" }, { "Text": "7.5 License Option Exercise Fee. On a Target Program Slot-by-Target Program Slot basis, if AbbVie exercises a License Option with respect to a Target Program Slot, then AbbVie shall pay to Anima a one-time non-refundable, non-creditable payment of Five Million Dollars ($5,000,000) (the \"License Option Exercise Fee\") within thirty (30) days after submitting the License Option Exercise Notice with respect to such License Option. Notwithstanding any provision to the contrary in this Agreement, if AbbVie exercises a License Option with respect to a Target Program Slot prior to paying the License Option Period Extension Fee with respect to the then-current Collaboration Target for such Target Program Slot, then AbbVie shall pay Anima an amount equal to the License Option Period Extension Fee simultaneously with the payment of the applicable License Option Exercise Fee, and Anima shall complete the remaining activities under the applicable Collaboration Plan pursuant to Section 2.10.1 (Activities under Collaboration Plan).", "": "" }, { "Text": "7.6 Development and Regulatory Milestone Payments. In partial consideration for the rights and licenses granted to AbbVie hereunder, and subject to Section 7.10 (Royalty and Milestone Adjustments), within ninety (90) days after the first achievement of each milestone event set forth in this Section 7.6 (Development and Regulatory Milestone Payments) with respect to a Target Program Slot (each, a \"Development Milestone Event\") by or on behalf of AbbVie, any of its Affiliates, or any Sublicensee (other than any Dispute Settlement Sublicensee), AbbVie shall make a non-refundable, non- creditable milestone payment to Anima in the amount set forth in this Section 7.6 (Development and Regulatory Milestone Payments) corresponding to such Development Milestone Event (each, a \"Development Milestone Payment\"). Each Development Milestone Payment shall be payable on a Target Program Slot-by-Target Program Slot basis, only upon the first achievement of the corresponding Development Milestone Event by a Royalty-Bearing Product with respect to a Target Program Slot, and no amounts shall be due for subsequent or repeated achievements of such Development Milestone Event with respect to the same Target Program Slot. For purposes of this Section 7.6 (Development and Regulatory Milestone Payments), \"Acceptance\" means, with respect to a Regulatory Approval Application for a Royalty-Bearing Product, the date upon which the FDA or EMA, as applicable, notifies or otherwise confirms to a Party, its Affiliate, or its Sublicensee that it has accepted such Regulatory Approval Application for review of whether to grant Regulatory Approval.", "": "" }, { "Text": "Development Milestone Event", "": "" }, { "Text": "(1) Initiation of first (1st) IND-Enabling Studies for a Royalty-Bearing Product with respect to a Target Program Slot", "": "" }, { "Text": "(2) Dosing of third (3rd) patient in the first Phase 1 Clinical Trial of a Royalty-Bearing Product with respect to a Target Program Slot", "": "" }, { "Text": "(3) Dosing of first (1st) patient in the first Phase 2 Clinical Trial of a Royalty-Bearing Product with respect to a Target Program Slot", "": "" }, { "Text": "(4) Dosing of first (1st) patient in the first Registrational Clinical Trial of a Royalty-Bearing Product with respect to a Target Program Slot", "": "" }, { "Text": "(5) Acceptance by the FDA of the first Regulatory Approval Application of a Royalty-Bearing Product with respect to a Target Program Slot", "": "" }, { "Text": "(6) Acceptance by the EMA of the first Regulatory Approval Application of a Royalty-Bearing Product with respect to a Target Program Slot", "": "" }, { "Text": "On a Target Program Slot-by-Target Program Slot basis, if for any reason a Development Milestone Event does not occur prior to the occurrence of the next Development Milestone Event listed in the table above, then such prior non-occurring Development Milestone Event shall be deemed to occur concurrently with the occurrence of such next Development Milestone Event, so that for example, a Royalty-Bearing Product with respect to a Target Program Slot that achieves Development Milestone Event number five (#5) or six (#6) in the table above will be deemed to have successfully achieved all of the preceding Development Milestone Events number one (#1) through four (#4) with respect to such Target Program Slot, provided, however, (a) if the Regulatory Approval Application in Development Milestone Event number five (#5) or six (#6) is for Accelerated Approval (with respect to the FDA) or Conditional Marketing Authorization (with respect to the EMA), as applicable, then Development Milestone Event number four (#4) shall not be deemed to have occurred concurrently and shall instead be deemed to occur (i) when the dosing of the first (1st) patient in the first Registrational Clinical Trial of a Royalty-Bearing Product with respect to the applicable Target Program Slot actually occurs or (ii) if and when both the FDA and EMA provide written notice to AbbVie or its Affiliate or Sublicensee, as applicable, that such party will not be required to conduct a Registrational Clinical Trial for the first Royalty-Bearing Product with respect to the applicable Target Program Slot in order to obtain Regulatory Approval other than Accelerated Approval (with respect to the FDA) or Conditional Marketing Authorization (with respect to the EMA) for such Royalty-Bearing Product in the United States or EU, as applicable, whichever ((i) or (ii)) is earlier and (b) if Development Milestone Event number six (#6) is achieved before Development Milestone Event number five (#5), then Development Milestone Event number five (#5) shall not be deemed to have occurred concurrently and shall instead be deemed to occur when it actually occurs. Additionally, for avoidance of doubt, Development Milestone Events number one (#1) through four (#4) shall all be deemed to have occurred with respect to a Target Program Slot if AbbVie is obligated to make any Annual Net Sales-Based Milestone Payment with respect to such Target Program Slot pursuant to Section 7.7 (Sales-Based Milestone Payments); provided that if the achievement of the applicable Annual Net Sales milestone threshold was based on sales made pursuant to an Accelerated Approval (with respect to the FDA), Conditional Marketing Authorization (with respect to the EMA), or similar accelerated or conditional Regulatory Approval in other countries or jurisdictions in the Territory, as applicable, then Development Milestone Event number four (#4) shall not be deemed to have occurred concurrently and shall instead be deemed to occur when (A) the dosing of the first (1st) patient in the first Registrational Clinical Trial of a Royalty-Bearing Product with respect to the applicable Target Program Slot actually occurs or (B) if and when both the FDA and EMA provide written notice to AbbVie or its Affiliate or Sublicensee, as applicable, that such party will not be required to conduct a Registrational Clinical Trial for the first Royalty-Bearing Product with respect to the applicable Target Program Slot in order to obtain Regulatory Approval other than Accelerated Approval (with respect to the FDA) or Conditional Marketing Authorization (with respect to the EMA) for such Royalty-Bearing Product in the United States or EU, as applicable, whichever ((A) or (B)) is earlier.", "": "" }, { "Text": "7.7 Sales-Based Milestone Payments. In partial consideration for the rights and licenses granted to AbbVie hereunder, and subject to Section 7.10 (Royalty and Milestone Adjustments), in the event that the aggregate Annual Net Sales of all Royalty-Bearing Products with respect to a Target Program Slot by AbbVie or any of its Affiliates or Sublicensees (other than Dispute Settlement Sublicensees) in a given Calendar Year exceeds a threshold (each, an \"Annual Net Sales Milestone Threshold\") set forth in the left-hand column of the table in this Section 7.7 (Sales-Based Milestone Payments) (the \"Annual Net Sales-Based Milestone Table\"), AbbVie shall pay to Anima a one-time non-refundable, non-creditable milestone payment (each, an \"Annual Net Sales-Based Milestone Payment\") in the corresponding amount set forth in the right-hand column of the Annual Net Sales-Based Milestone table below. In the event that in a given Calendar Year more than one (1) Annual Net Sales Milestone Threshold is exceeded, AbbVie shall pay to Anima a separate Annual Net Sales-Based Milestone Payment with respect to each Annual Net Sales Milestone Threshold that is exceeded in such Calendar Year. Each such milestone payment shall be due within ninety (90) days after the end of the Calendar Year in which such milestone was achieved. Each Annual Net Sales-Based Milestone Payment shall be payable on a Target Program Slot-by-Target Program Slot basis, only upon the first achievement of such milestone with respect to a Target Program Slot, and no amounts shall be due for subsequent or repeated achievements of such milestone with respect to the same Target Program Slot.", "": "" }, { "Text": "Annual Net Sales Milestone Threshold", "": "" }, { "Text": "Aggregate Annual Net Sales of all Royalty-Bearing Products with respect to a Target Program Slot greater than or equal to One Billion Dollars ($1,000,000,000)", "": "" }, { "Text": "Aggregate Annual Net Sales of all Royalty-Bearing Products with respect to a Target Program Slot greater than or equal to Two Billion Dollars ($2,000,000,000)", "": "" }, { "Text": "Aggregate Annual Net Sales of all Royalty-Bearing Products with respect to a Target Program Slot greater than or equal to Three Billion Dollars ($3,000,000,000)", "": "" }, { "Text": "7.8 Royalties.", "": "" }, { "Text": "7.8.1 Royalty Rates. Subject to the terms and conditions of this Agreement, including Section 7.9 (Royalty Term) and Section 7.10 (Royalty and Milestone Adjustments), commencing upon the First Commercial Sale of a Royalty-Bearing Product in a country in the Territory, on a Target Program Slot-by-Target Program Slot and country-by-country basis, AbbVie shall pay to Anima royalties on the Net Sales of each Royalty-Bearing Product in each country in the Territory during the applicable Royalty Term at the following rates, which are based on the aggregate Annual Net Sales of all Royalty-Bearing Products with respect to the same Target Program Slot:", "": "" }, { "Text": "Aggregate Annual Net Sales of all Royalty-Bearing Products with respect to a Target Program Slot", "": "" }, { "Text": "For that portion of aggregate Annual Net Sales of all Royalty-Bearing Products with respect to a Target Program Slot less than or equal to Five Hundred Million Dollars ($500,000,000)", "": "" }, { "Text": "For that portion of aggregate Annual Net Sales of all Royalty-Bearing Products respect to a Target Program Slot greater than Five Hundred Million Dollars ($500,000,000) and less than or equal to One Billion Dollars ($1,000,000,000)", "": "" }, { "Text": "For that portion of aggregate Annual Net Sales of all Royalty-Bearing Products with respect to a Target Program Slot greater than One Billion Dollars ($1,000,000,000) and less than or equal to Two Billion Dollars ($2,000,000,000)", "": "" }, { "Text": "For that portion of aggregate Annual Net Sales of all Royalty-Bearing Products respect to a Target Program Slot greater than Two Billion Dollars ($2,000,000,000)", "": "" }, { "Text": "With respect to a given Royalty-Bearing Product in a given country in the Territory, from and after the expiration of the Royalty Term for the applicable Royalty-Bearing Product in such country, Net Sales of such Royalty-Bearing Product in such country will be excluded for purposes of calculating the Net Sales thresholds and ceilings set forth in this Section 7.8.1 (Royalty Rates).", "": "" }, { "Text": "7.8.2 Calculation of Royalties. With respect to each Royalty-Bearing Product with respect to a Target Program Slot, royalties on Net Sales of such Royalty-Bearing Product shall be paid at the rate applicable to that portion of aggregate Annual Net Sales of all such Royalty-Bearing Products with respect to such Target Program Slot within each of the Net Sales tiers set forth in Section 7.8.1 (Royalty Rates) during the applicable Calendar Year. For example, if, during a Calendar Year, aggregate Annual Net Sales of all of the Royalty-Bearing Products with respect to a Target Program Slot are equal to One Billion Five Hundred Million Dollars ($1,500,000,000), then, absent any adjustment to such royalty payments in accordance with the terms of this Agreement, the aggregate royalties payable by AbbVie with respect to all such Royalty-Bearing Products with respect to such Target Program Slot for such Calendar Year would be calculated by adding (a) the royalties with respect to the first Five Hundred Million Dollars ($500,000,000) at the first-level percentage of five percent (5%) ($500,000,000 x 0.05 = $25,000,000), (b) the royalties with respect to the next Five Hundred Million Dollars ($500,000,000) at the second-level percentage of six percent (6%) ($500,000,000 x 0.06 = $30,000,000), and (c) the royalties with respect to the final Five Hundred Million Dollars ($500,000,000) at the third-level percentage of seven percent (7%) ($500,000,000 x 0.07 = $35,000,000), for a total of Ninety Million Dollars ($90,000,000).", "": "" }, { "Text": "7.9 Royalty Term. On a country-by-country and Royalty-Bearing Product-by-Royalty-Bearing Product basis, royalty payments on Net Sales of each Royalty-Bearing Product in a country in the Territory shall commence upon the First Commercial Sale of such Royalty-Bearing Product in such country and shall terminate on the ten- (10-) year anniversary of the date of such First Commercial Sale (the applicable \"Royalty Term\"); provided that, on a Target Program Slot-by-Target Program Slot basis, in no event shall AbbVie owe any royalties under this Agreement with respect to any Target Program Slot after the fifteen- (15-) year anniversary of the date of the First Commercial Sale of the first Royalty-Bearing Product with respect to such Target Program Slot, and the Royalty Term shall be deemed to have expired with respect to all countries and Royalty-Bearing Products with respect to such Target Program Slot as of such date.", "": "" }, { "Text": "7.10 Royalty and Milestone Adjustments. Notwithstanding Section 7.6 (Development and Regulatory Milestone Payments), Section 7.7 (Sales-Based Milestone Payments) or Section 7.8.1 (Royalty Rates), but subject to Section 7.10.4 (Mechanics of Adjustments to Royalties and Milestones):", "": "" }, { "Text": "7.10.1 Generic Products. If, in any country in the Territory during the Royalty Term in such country for a Royalty-Bearing Product, a Generic Product with respect to such Royalty-Bearing Product is launched in such country, then (a) Net Sales of such Royalty-Bearing Product in such country shall thereafter be excluded for the purposes of calculating the Net Sales thresholds and ceilings pursuant to Section 7.7 (Sales-Based Milestone Payments) and (b) the royalty rate for such Royalty-Bearing Product with respect to such country shall thereafter be reduced by fifty percent (50%) from the applicable rate(s) set forth in Section 7.8.1 (Royalty Rates).", "": "" }, { "Text": "7.10.2 Stacking. If AbbVie or any of its Affiliates determines in good faith that, in order to avoid infringement or misappropriation of any Third Party Right, it is necessary or reasonably useful to obtain a license from a Third Party in order for AbbVie, its Affiliates, or its Sublicensees to Exploit a Royalty-Bearing Product in the Field in a country in the Territory, and AbbVie or any of its Affiliates actually enters into any such license, then AbbVie shall be entitled to deduct from AbbVie's milestone payments under Section 7.6 (Development and Regulatory Milestone Payments) or Section 7.7 (Sales-Based Milestone Payments) or AbbVie's royalty payments under Section 7.8.1 (Royalty Rates), in each case, for such Royalty-Bearing Product in a Calendar Quarter, fifty percent (50%) of the royalties, milestones, and other amounts actually paid by AbbVie or any of its Affiliates to such Third Party to the extent applicable to such Royalty-Bearing Product during such Calendar Quarter, up to the maximum permitted deduction set forth in Section 7.10.4 (Mechanics of Adjustments to Royalties and Milestones).", "": "" }, { "Text": "7.10.3 Intellectual Property Expense Offsets. AbbVie shall be entitled to deduct from AbbVie's milestone payments under Section 7.6 (Development and Regulatory Milestone Payments) or Section 7.7 (Sales-Based Milestone Payments) or AbbVie's royalty payments under Section 7.8.1 (Royalty Rates): (a) up to fifty percent (50%) of the reasonable out-of-pocket costs of defending a Third Party Infringement Claim under Section 9.5 (Infringement Claims by Third Parties) in accordance with the terms of Section 9.5 (Infringement Claims by Third Parties) and (b) up to fifty percent (50%) of the reasonable out-of-pocket costs of defending a claim, suit, or proceeding under Section 9.6 (Invalidity or Unenforceability Defense or Actions) in accordance with the terms of Section 9.6.4 (Costs and Expenses), in each case ((a) and (b)) up to the maximum permitted deduction set forth in Section 7.10.4 (Mechanics of Adjustments to Royalties and Milestones).", "": "" }, { "Text": "7.10.4 Mechanics of Adjustments to Royalties and Milestones. Any reductions set forth in this Section 7.10 (Royalty and Milestone Adjustments) shall be applied to the milestone payment or royalty rate payable to Anima under Section 7.6 (Development and Regulatory Milestone Payments), Section 7.7 (Sales-Based Milestone Payments), or Section 7.8.1 (Royalty Rates), as applicable, in the order in which the event triggering such reduction occurs; provided that (a) the deductions made pursuant to Section 7.10.2 (Stacking) shall not reduce by more than fifty percent (50%) the milestone payments that would otherwise be owed under Section 7.6 (Development and Regulatory Milestone Payments) or Section 7.7 (Sales-Based Milestone Payments), (b) the adjustments made pursuant to Section 7.10.1 (Generic Products) and Section 7.10.2 (Stacking) shall not cumulatively reduce by more than fifty percent (50%) the royalties that would otherwise be owed under Section 7.8.1 (Royalty Rates), and (c) notwithstanding the foregoing clauses (a) and (b), the adjustments made pursuant to Section 7.10.1 (Generic Products), Section 7.10.2 (Stacking), and Section 7.10.3 (Intellectual Property Expense Offsets) shall in no case reduce by more than sixty percent (60%) the milestone payments that would otherwise be owed under Section 7.6 (Development and Regulatory Milestone Payments) or Section 7.7 (Sales-Based Milestone Payments) or the royalties that would otherwise have been owed under Section 7.8.1 (Royalty Rates). Credits for reductions pursuant to this Section 7.10 (Royalty and Milestone Adjustments) not exhausted in any Calendar Quarter may be carried into future Calendar Quarters, subject to the preceding sentence. Any adjustments pursuant to Section 7.10 (Royalty and Milestone Adjustments) shall be allocated pro rata across each of the royalty tiers in the relevant Calendar Quarter.", "": "" }, { "Text": "7.10.5 Inflation Reduction Act Royalty Adjustments. In addition to any reductions set forth in Sections 7.10.1 (Generic Products), 7.10.2 (Stacking), and 7.10.3 (Intellectual Property Expense Offsets), if, during the Royalty Term for a Royalty-Bearing Product, such Royalty-Bearing Product is designated as a \"selected drug\" by the Secretary of the U.S. Department of Health and Human Services, and AbbVie or its Affiliate or Sublicensee is required to negotiate a maximum fair price that shall apply to sales of such Royalty-Bearing Product during the price applicability period as specified in the Inflation Reduction Act, then the applicable royalty rates set forth in Section 7.8.1 (Royalty Rates) payable to Anima for the Net Sales of such Royalty-Bearing Product in the United States shall be reduced pro rata by a percentage equal to the percentage by which the price of such Royalty-Bearing Product is decreased as a result of such selection and the ensuing price negotiation pursuant to the Inflation Reduction Act. Any adjustment of royalties pursuant to this Section 7.10.5 (Inflation Reduction Act Royalty Adjustments) shall apply after and in addition to any adjustments to royalties pursuant to Section 7.10.4 (Mechanics of Adjustments to Royalties and Milestones). By way of example, if the price of a Royalty-Bearing Product is decreased by ten percent (10%) and the royalty rate initially payable to Anima is five percent (5%), then the royalty rate payable to Anima would be reduced by ten percent (10%), to a final royalty rate of four and one-half percent (4.5%).", "": "" }, { "Text": "7.11 Estimated Sales Levels. Anima acknowledges and agrees that the sales levels set forth in Section 7.7 (Sales-Based Milestone Payments) and Section 7.8.1 (Royalty Rates) shall not be construed as representing an estimate or projection of anticipated sales of the Royalty-Bearing Products, or implying any level of diligence or Commercially Reasonable Efforts, in the Territory, and that the sales levels set forth in such Sections are merely intended to define AbbVie's milestone payment or royalty obligations, as applicable, in the event such sales levels are achieved.", "": "" }, { "Text": "7.12 Reports; Payment of Royalty. During the Term, following the First Commercial Sale of any Royalty-Bearing Product in any country in the Territory, AbbVie shall furnish to Anima a written report within sixty (60) days after the end of each Calendar Quarter showing, on a Royalty-Bearing Product-by-Royalty-Bearing Product and country-by-country basis, the Net Sales of each Royalty-Bearing Product in each country of the Territory and the royalties payable under this Agreement. Royalties with respect to Net Sales of Royalty-Bearing Products shall be due and payable on the date such royalty report is due.", "": "" }, { "Text": "7.13 Financial Records. AbbVie shall, and shall cause its Affiliates and its and their Sublicensees (other than Dispute Settlement Sublicensees) to, keep full, clear, and accurate records pertaining to Net Sales for a minimum period of three (3) years after the relevant payment is owed pursuant to this Agreement, in sufficient detail to enable royalties and compensation payable to Anima hereunder to be calculated and verified.", "": "" }, { "Text": "7.14 Audit; Audit Dispute.", "": "" }, { "Text": "7.14.1 Audit. At the request of Anima, AbbVie shall, and shall cause its Affiliates to, permit an independent public accounting firm of nationally recognized standing designated by Anima and reasonably acceptable to AbbVie, at reasonable times during normal business hours and upon reasonable notice, to audit the books and records of AbbVie maintained pursuant to Section 7.13 (Financial Records) to ensure the accuracy of all reports of Net Sales and related payments made hereunder. Such examinations may not, (a) be conducted for any Calendar Quarter more than three (3) years after the end of such quarter, (b) be conducted more than once in any twelve (12) month period, or (c) be repeated for any Calendar Quarter. The accounting firm shall disclose only whether the reports are correct or not, and the specific details concerning any discrepancies. No other information shall be shared. Except as provided below, the cost of such audit shall be borne by Anima, unless the audit reveals a variance of more than the greater of ten percent (10%) or Five Hundred Thousand Dollars ($500,000) from the reported amounts, in which case AbbVie shall bear the cost of the audit. Unless disputed pursuant to Section 7.14.2 (Audit Dispute) below, if such audit concludes that (i) additional amounts were owed by AbbVie, then AbbVie shall pay the additional amounts, with interest from the date originally due as provided in Section 7.17 (Late Payments), or (ii) excess payments were made by AbbVie, then Anima shall reimburse such excess payments, in either case ((i) or (ii)), within ninety (90) days after the date on which such audit is completed by Anima.", "": "" }, { "Text": "7.14.2 Audit Dispute. In the event of a dispute with respect to any audit under Section 7.14.1 (Audit), Anima and AbbVie shall work in good faith to resolve the disagreement. If the Parties are unable to reach a mutually acceptable resolution of any such dispute within thirty (30) days, then the dispute shall be submitted for resolution to a certified public accounting firm jointly selected by each Party's certified public accountants or to such other Person as the Parties shall mutually agree (the \"Audit Arbitrator\"). The decision of the Audit Arbitrator shall be final and the costs of such arbitration as well as the initial audit shall be borne between the Parties in such manner as the Audit Arbitrator shall determine. Not later than thirty (30) days after such decision and in accordance with such decision, AbbVie shall pay the additional amounts, with interest from the date originally due as provided in Section 7.17 (Late Payments), or Anima shall reimburse the excess payments, as applicable.", "": "" }, { "Text": "7.15 Methods of Payments; Offsets. All payments to either Party under this Agreement shall be made by deposit of Dollars in the requisite amount to such bank account as the receiving Party may from time to time designate by notice to the paying Party. For the purpose of calculating any sums due under, or otherwise reimbursable pursuant to, this Agreement (including the calculation of Net Sales expressed in currencies other than Dollars), a Party shall convert any amount expressed in a foreign currency into Dollar equivalents using its, its Affiliate's, or its applicable Sublicensee's standard conversion methodology consistent with Accounting Standards. AbbVie shall have the right to offset any undisputed or finally adjudicated payment that is owed by Anima against any payments owed by AbbVie, if any, under this Agreement.", "": "" }, { "Text": "7.16 Taxes.", "": "" }, { "Text": "7.16.1 Income Taxes. Each Party shall be solely responsible for the payment of all taxes imposed on its share of income arising directly or indirectly from the activities of the Parties under this Agreement.", "": "" }, { "Text": "7.16.2 Withholding Taxes. If any sum due to be paid to either Party hereunder is subject to any withholding or similar tax, then the Parties shall use their Commercially Reasonable Efforts to do all such acts and things and to sign all such documents as will enable them to secure any available exemption from, reduction in, or refund of such tax, including by taking advantage of any applicable double taxation agreement or treaty. In the event there is no applicable double taxation agreement or treaty, or if an applicable double taxation agreement or treaty reduces but does not eliminate such withholding or similar tax, the payor shall remit such withholding or similar tax to the appropriate Governmental Authority, deduct the amount paid from the amount due to payee and secure and send to payee the best available evidence of the payment of such withholding or similar tax. Any such amounts deducted by the payor in respect of such withholding or similar tax shall be treated as having been paid by the payor for purposes of this Agreement. In the event that a Governmental Authority retroactively determines that a payment made by a Party to the other Party pursuant to this Agreement should have been subject to withholding or similar (or to additional withholding or similar) taxes, and such Party (the \"Withholding Party\") remits such withholding or similar taxes to the Governmental Authority, including any interest and penalties that may be imposed thereon (together with the tax paid, the \"Withholding Amount\"), the Withholding Party will have the right (a) to offset the Withholding Amount against future payment obligations of the Withholding Party under this Agreement, (b) to invoice the other Party for the Withholding Amount (which shall be payable by the other Party within sixty (60) days of its receipt of such invoice), or (c) to pursue reimbursement of the Withholding Amount by any other available remedy.", "": "" }, { "Text": "7.16.3 Indirect Taxes. All payments under this Agreement are exclusive of value added taxes, sales taxes, consumption taxes, and other similar taxes (the \"Indirect Taxes\"). If any Indirect Taxes are chargeable in respect of any payment under this Agreement, then the paying Party shall pay such Indirect Taxes at the applicable rate in respect of such payment following receipt, where applicable, of an Indirect Taxes invoice in the appropriate form issued by the receiving Party in respect of those payments. The Parties shall issue invoices for all amounts payable under this Agreement consistent with Indirect Tax requirements and irrespective of whether the sums may be netted for settlement purposes. If the Indirect Taxes originally paid or otherwise borne by the paying Party are in whole or in part subsequently determined not to have been chargeable, then the receiving Party shall use Commercially Reasonable Efforts to take all necessary steps to receive a refund of these undue Indirect Taxes from the applicable Governmental Authority or other fiscal authority and any amount of undue Indirect Taxes repaid by such authority to the receiving Party will be transferred to the paying Party within forty-five (45) days of receipt by the receiving Party.", "": "" }, { "Text": "7.16.4 Tax Domicile. If, following the Effective Date, as a result of AbbVie assigning this Agreement or changing its domicile to a domicile other than the jurisdiction of AbbVie's domicile as of the Effective Date, AbbVie is required by applicable Law to withhold additional taxes with respect to the payments under this Agreement and such withholding taxes exceed the amount of withholding taxes that would have been applicable if such action had not occurred, AbbVie shall be responsible for all such additional taxes and shall pay Anima such amounts as are necessary to ensure that Anima receives the same amount as it would have received had no such assignment or change in domicile been made by AbbVie; provided, however, AbbVie will have no obligation to pay any additional amount under the immediately preceding clause (a) to the extent Anima obtains a refund or exemption of such additional amounts, (b) if Anima has the ability to offset such withheld amounts against other tax liabilities Anima has in the applicable jurisdiction and such amounts are actually so offset, or (c) if such increased withholding tax would not have been imposed but for Anima assigning this Agreement or changing its domicile to a domicile other than the jurisdiction of Anima's domicile as of the Effective Date.", "": "" }, { "Text": "7.17 Late Payments. Any undisputed amount owed by AbbVie to Anima under this Agreement that is not paid on or before the date such payment is due shall bear interest at an annual rate (but with interest accruing on a daily basis) of the lesser of (a) one hundred (100) basis points above the Secured Overnight Financing Rate for a thirty- (30-) day term published by the U.S. Federal Reserve Bank of New York, as adjusted from time to time on the first New York business day of each month, or (b) the maximum interest rate allowed under applicable Law, such interest to run from the date on which payment of such sum became due until payment thereof in full together with such interest.", "": "" }, { "Text": "7.18 Financial Obligations under In-License Agreements. As between the Parties, Anima shall be solely responsible for any financial obligations, including royalties, due to any Third Party as consideration for obtaining a license or other rights under any Patent Right or Know-How that is owned by a Third Party and is necessary or reasonably useful for (a) Anima to conduct its activities under this Agreement or (b) AbbVie or its Affiliates or Sublicensees to exercise AbbVie's rights under the Licensed IP, Anima Background Patents, or Anima Background Know-How in accordance with the terms of this Agreement, in each case ((a) and (b)) without infringing or misappropriating the intellectual property rights of a Third Party. If Anima or any of its Affiliates breaches or defaults under any of its payment obligations any such Third Party, then Anima shall promptly notify AbbVie in writing of any such payment breach or default and AbbVie and its Affiliates and Sublicensees shall have the right (but not the obligation), in its sole discretion, to cure any such payment breach or default (including by paying such amounts directed to such Third Party). In the event that AbbVie or an Affiliate or Sublicensee of AbbVie pays any such amount due to any such Third Party, Anima shall reimburse AbbVie or such Affiliate or Sublicensee for such amount within ninety (90) days following its receipt of an invoice therefor.", "": "" }, { "Text": "ARTICLE 8 EXCLUSIVITY; CHANGE OF CONTROL", "": "" }, { "Text": "8.1 Exclusivity.", "": "" }, { "Text": "8.1.1 Anima Exclusivity Obligation.", "": "" }, { "Text": "(a) Reserved Targets. During the period beginning on the Effective Date and ending on the earlier of (i) the five- (5-) year anniversary thereof or (ii) if AbbVie does not exercise its License Option with respect to any Collaboration Target during the applicable License Option Period, the date of expiration of the last-to-expire License Option Period for a Collaboration Target, with respect to each Reserved Target that is not designated as a Collaboration Target in accordance with the terms of this Agreement, neither Anima nor its Affiliates shall, directly or indirectly: (A) conduct any screening or other research activities with respect to such Reserved Target; (B) intentionally generate data with respect to such Reserved Target; (C) conduct activities to Exploit any molecule, compound, product, or other therapeutic agent that is known to Anima or its Affiliate to be Directed To such Reserved Target; or (D) license, authorize, appoint, or otherwise enable any Third Party to conduct any activities described in the foregoing (A) through (C), in each case ((A) through (D)) anywhere in the Territory except to conduct activities expressly permitted under this Agreement on AbbVie's behalf or to conduct activities expressly permitted under Section 8.1.1(f). For clarity, a target shall not be a \"Reserved Target\" under this Agreement following expiration of the exclusivity period set forth in this Section 8.1.1(a) (Reserved Targets) or following expiration or termination of this Agreement in its entirety.", "": "" }, { "Text": "(b) Collaboration Targets for which License Option has not been Exercised. On a Collaboration Target-by-Collaboration Target basis, during the period beginning on the Effective Date and ending on the expiration of the applicable License Option Period with respect to each Collaboration Target for which AbbVie does not exercise its License Option during the applicable License Option Period in accordance with the terms of this Agreement, neither Anima nor its Affiliates shall, directly or indirectly: (i) conduct any screening or other research activities with respect to such Collaboration Target; (ii) intentionally generate data with respect to such Collaboration Target; (iii) conduct activities to Exploit any molecule, compound, product, or other therapeutic agent that is known to Anima or its Affiliate to be Directed To such Collaboration Target; or (iv) license, authorize, appoint, or otherwise enable any Third Party to conduct any activities described in the foregoing (i) through (iii), in each case ((i) through (iv)) anywhere in the Territory except to conduct activities expressly permitted under this Agreement on AbbVie's behalf or to conduct activities expressly permitted under Section 8.1.1(f). For clarity, a target shall not be a \"Collaboration Target\" under this Agreement (and as such shall not be subject to the exclusivity provisions set forth in this Section 8.1.1(b) (Collaboration Targets for Which License Option is Not Exercised)) following (A) replacement of such target with another target pursuant to Section 2.3 (Collaboration Target Substitution), (B) termination of this Agreement with respect to such target, or (C) expiration or termination of this Agreement in its entirety, in which case ((A)-(C)) such target will be deemed to not be a Collaboration Target.", "": "" }, { "Text": "(c) Collaboration Targets for which License Option is Exercised.", "": "" }, { "Text": "(i) Solely in the U.S., on a Collaboration Target-by-Collaboration Target basis, during the period beginning on the Effective Date and ending on the five- (5-) year anniversary of the expiration or termination of this Agreement in its entirety, with respect to each Collaboration Target for which AbbVie exercises its License Option during the applicable License Option Period in accordance with the terms of this Agreement, neither Anima or its Affiliates shall, directly or indirectly: (A) conduct any screening or other research activities with respect to such Collaboration Target; (B) intentionally generate data with respect to such Collaboration Target; (C) conduct activities to Exploit any molecule, compound, product, or other therapeutic agent that is known to Anima or its Affiliate to be Directed To such Collaboration Target; or (D) license, authorize, appoint, or otherwise enable any Third Party to conduct any activities described in the foregoing (A) through (C), in each case ((A) through (D)), in the U.S. except to conduct activities expressly permitted under this Agreement on AbbVie's behalf or to conduct activities expressly permitted under Section 8.1.1(f).", "": "" }, { "Text": "(ii) Anywhere in the Territory other than the U.S., the following terms shall apply to each Collaboration Target for which AbbVie exercises its License Option during the applicable License Option Period in accordance with the terms of this Agreement:", "": "" }, { "Text": "A. Development Exclusivity Obligation. On a Collaboration Target-by-Collaboration Target basis, neither Anima nor its Affiliates shall, directly or indirectly: (w) conduct any screening or other research activities with respect to such Collaboration Target; (x) intentionally generate data with respect to such Collaboration Target; (y) conduct any research or pre-clinical or clinical development activities (or any manufacturing activities therefor) with respect to any molecule, compound, product, or other therapeutic agent that is known to Anima or its Affiliate to be Directed To such Collaboration Target, or (z) license, authorize, appoint, or otherwise enable any Third Party to conduct any activities described in the foregoing (w) through (y), in each case ((w) through (z)) anywhere in the Territory other than the U.S. during the period beginning on the Effective Date and ending, on a Collaboration Target-by-Collaboration Target and country-by-country basis, on the earliest to occur of the following: (1) the date of the first Regulatory Approval of a Royalty-Bearing Product Directed To such Collaboration Target in the applicable country in the Territory other than the U.S. or (2) the date the Parties agree in writing, and with specific reference to this Section, to terminate all Development activities under this Agreement with respect to all Royalty-Bearing Products Directed To such Collaboration Target in the applicable country in the Territory other than the U.S., and in each case ((w) through (z)) except to conduct activities expressly permitted under this Agreement on AbbVie's behalf or to conduct activities expressly permitted under Section 8.1.1(f).", "": "" }, { "Text": "B. Commercialization Exclusivity Obligation. On a Collaboration Target-by-Collaboration Target basis, during the period beginning on the date of the first Regulatory Approval of a Royalty-Bearing Product Directed To such Collaboration Target anywhere in the Territory other than the U.S. and ending on the five- (5)- year anniversary of the effective date of the expiration or termination of this Agreement in its entirety, neither Anima nor its Affiliates shall: (y) directly or indirectly conduct any commercialization activities (or any manufacturing activities therefor) with respect to any molecule, compound, product, or other therapeutic agent that is known to Anima or its Affiliate to be Directed To such Collaboration Target, or (z) license, authorize, appoint, or otherwise enable any Third Party to conduct any commercialization activities (or any manufacturing activities therefor) with respect to any molecule, compound, product, or other therapeutic agent that is known to Anima or its Affiliate to be Directed To such Collaboration Target, in each case ((y) and (z)) anywhere in the Territory other than the U.S. except to conduct activities expressly permitted under this Agreement on AbbVie's behalf or to conduct activities expressly permitted under Section 8.1.1(f); provided that, on a Collaboration Target-by-Collaboration Target and country-by-country basis, this Section 8.1.1(c)(ii)B (Commercialization Exclusivity Obligation) shall not prohibit Anima from conducting the activities set forth in the foregoing clauses (y) and (z) after the seven- (7-) year anniversary of the first Regulatory Approval of a Royalty-Bearing Product Directed To such Collaboration Target in the applicable country in the Territory other than the U.S. unless AbbVie determines in writing prior to such seven- (7-) year anniversary and annually thereafter that the restriction under this Section 8.1.1(c)(ii)B (Commercialization Exclusivity Obligation) remains permissible under applicable Law. For clarity, the restriction in this Section 8.1.1(c)(ii)B (Commercialization Exclusivity Obligation) shall continue in relation to each applicable Collaboration Target for so long as AbbVie determines it remains permissible under applicable Law.", "": "" }, { "Text": "(d) Compound Library. In screening activities outside and independent of its collaboration with AbbVie under this Agreement, Anima and its Affiliates shall exclude from compound libraries of Anima and any un-blinded compound library of a Third Party all compounds that immediately prior to starting such screen are included in any License Option Exercise Data Package (including, for clarity, any in-process draft thereof). For clarity the obligation of this Section 8.1.1(d) (Compound Library) will not apply to blinded compound libraries of Anima's Third Party collaboration partners.", "": "" }, { "Text": "(e) ADCs. Anima shall not, and shall cause its Affiliates not to, conduct activities with respect to any ADC included in any License Option Exercise Data Package (including, for clarity, any in-process draft thereof) outside this Agreement, including in connection with Anima's or its Affiliate's independent research or any collaboration with a Third Party. Anima shall not, and shall cause its Affiliates not to, disclose any ADC included in any License Option Exercise Data Package (including, for clarity, any in-process draft thereof) to any Third Party except (i) to its approved subcontractors in accordance with Section 10.3.3 and solely as required to perform its activities under a Collaboration Plan or (ii) to a Third Party collaboration partner through a gatekeeping process reasonably acceptable to AbbVie solely to the extent (A) required by an agreement between Anima and such Third Party collaboration partner and (B) necessary for Anima to cause such Third Party collaboration partner to exclude such compounds from an un-blinded compound library of such Third Party pursuant to Section 8.1.1(d) (Compound Library), provided that such gatekeeper shall be subject to obligations of confidentiality and non-use with respect to such Confidential Information of AbbVie that are no less restrictive than the obligations of confidentiality and non-use of Anima pursuant to ARTICLE 10 (Confidentiality).", "": "" }, { "Text": "(f) The provisions of this Section 8.1.1 (Anima Exclusivity Obligation) and Section 4.1.1(b) (Commercial Licenses) shall not restrict:", "": "" }, { "Text": "(i) Anima or its Affiliates (A) from directly or indirectly conducting activities with respect to a molecule, compound, product, or other therapeutic agent (other than any ADC included in any License Option Exercise Data Package (including, for clarity, any in-process draft thereof)) pursuant to an agreement with a Third Party, where both such activities and such Third Party agreement are not related to a target that is a Collaboration Target or Reserved Target, or (B) from licensing, authorizing, appointing, or otherwise enabling any Third Party to Exploit a molecule, compound, product, or other therapeutic agent (other than any ADC included in any License Option Exercise Data Package (including, for clarity, any in-process draft thereof)), in each case ((A) and (B)) provided that such molecule, compound, product, or other therapeutic agent is not known to Anima or its Affiliates as of the signing of an agreement with a Third Party for such Exploitation to be Directed To a Reserved Target or Collaboration Target, as applicable;", "": "" }, { "Text": "(ii) Anima or its Affiliates from directly or indirectly conducting, under an independent internal research program (i.e., not a program pursuant to an agreement with a Third Party, which is covered by the foregoing Section 8.1.1(f)(i)) not related to a target that is a Collaboration Target or Reserved Target, activities with respect to the Exploitation of a molecule, compound, product, or other therapeutic agent (other than any ADC included in any License Option Exercise Data Package (including, for clarity, any in-process draft thereof)) that is not known to Anima or its Affiliate, at the time of Anima conducting such activities, to be Directed To a Reserved Target or Collaboration Target, as applicable; provided that, as soon as Anima or any of its Affiliates generates data demonstrating that such molecule, compound, product, or other therapeutic agent is Directed To a Reserved Target or Collaboration Target, as applicable, Anima and its Affiliates will cease any further activities with respect to such molecule, compound, product, or other therapeutic agent to the extent Anima or any such Affiliate is conducting such activities under an independent internal research program;", "": "" }, { "Text": "(iii) Anima or its Affiliates from granting licenses (including exclusive licenses for any purpose) to a Third Party under any Intellectual Property rights relating to any molecule, compound, product, or other therapeutic agent (other than any ADC included in any License Option Exercise Data Package (including, for clarity, any in-process draft thereof)) independently generated in the course of the activities permitted under Section 8.1.1(f)(i) or Section 8.1.1(f)(ii) above; and", "": "" }, { "Text": "(iv) the manner in which Anima's or its Affiliates' Third Party collaboration partners Exploit any molecule, compound, product, or other therapeutic agent (other than any ADC included in any License Option Exercise Data Package (including, for clarity, any in-process draft thereof)) independently generated in the course of the activities permitted under Section 8.1.1(f)(i) or Section 8.1.1(f)(ii) above and the Intellectual Property rights therein provided to them by Anima.", "": "" }, { "Text": "(g) For clarity, a target shall not be a \"Collaboration Target\" under this Agreement (and as such shall not be subject to the exclusivity set forth in Section 8.1.1(b) (Collaboration Targets for which License Option has not been Exercised)) following expiration or termination of this Agreement with respect to such target, or expiration or termination of this Agreement in its entirety; provided that, notwithstanding the foregoing, a target will continue to be a \"Collaboration Target\" subject to the exclusivity set forth in Section 8.1.1(c) (Collaboration Targets for Which License Option is Exercised) following expiration or termination of this Agreement for the period of time set forth in Section 8.1.1(c) (Collaboration Targets for which License Option is Exercised).", "": "" }, { "Text": "8.1.2 Effect of Change of Control of Anima. Notwithstanding the provisions of Section 8.1.1 (Anima Exclusivity Obligation), if Anima undergoes a Change of Control during the Term and, as of immediately prior to the closing of such Change of Control, any Person that becomes an Independent Affiliate of Anima upon such Change of Control (the \"Anima Acquirer\") is Exploiting any product, the Exploitation of which product in the Territory would, but for the provisions of this Section 8.1.2 (Effect of Change of Control of Anima) constitute a breach of Section 8.1.1 (Anima Exclusivity Obligation) (such product, a \"Distracting Product\"), then Anima or the Anima Acquirer, as applicable, will, within ten (10) days after the closing of such Change of Control notify AbbVie in writing of such Distracting Product and Anima and the Anima Acquirer, as applicable, and their Affiliates will reasonably segregate all research, development, and commercialization activities relating to the Distracting Product from the research, Development, and Commercialization with respect to compounds or products under this Agreement, including by ensuring that: (a) no personnel involved in performing research, development, or commercialization activities with respect to such Distracting Product have access to non-public plans or information relating to the research, Development, or Commercialization of compounds or products under this Agreement, any Patent Rights or Know-How exclusively licensed or to be exclusively licensed by Anima to AbbVie under this Agreement, or any Confidential Information of AbbVie; (b) no personnel involved in performing research, Development, or Commercialization activities with respect to compounds or products under this Agreement have access to non-public plans or information relating to the research, development, or commercialization of such Distracting Product, provided that, for clarity, this clause (b) shall not apply to personnel managing or overseeing general business strategy and product pipeline; (c) no Patent Rights or Know-How exclusively licensed or to be exclusively licensed by Anima to AbbVie under this Agreement, or Confidential Information of AbbVie, is used in the research, development, or commercialization of the Distracting Product; and (d) commercially reasonable technical and administrative safeguards are in place to ensure that the requirements set forth in the foregoing clauses (a) through (c) are met. For avoidance of doubt, subject to compliance with the foregoing, an Anima Acquirer shall not be restricted under this Agreement from Exploiting a Distracting Product.", "": "" }, { "Text": "8.2 Change of Control of Anima. If Anima undergoes a Change of Control during the Term, then:", "": "" }, { "Text": "(a) Anima shall notify AbbVie thereof immediately upon the closing of the Change of Control;", "": "" }, { "Text": "(b) Anima shall comply with the terms of Section 8.1.2 (Effect of Change of Control of Anima);", "": "" }, { "Text": "(c) AbbVie shall have the right, in its sole and absolute discretion, by written notice delivered to Anima (or its successor) at any time within one hundred eighty (180) days following the written notice contemplated by the foregoing clause (a), to: (i) terminate any or all provisions of this Agreement providing for any delivery by AbbVie to Anima of Confidential Information of AbbVie relating to activities contemplated by this Agreement, save only for the provisions of ARTICLE 7 (Upfront Fee; Milestones and Royalties; Payments); and (ii) require Anima and the Anima Acquirer to adopt reasonable procedures, proposed by AbbVie and to be agreed upon by the Parties in writing, to prevent disclosure of Confidential Information of AbbVie to the Anima Acquirer; and", "": "" }, { "Text": "(d) Anima covenants that, subject to the foregoing clause (c), there shall be no material change in the level or nature of efforts or resources expended by Anima and its Affiliates or the qualifications and experience of Anima's assigned personnel (including with respect to the allocation of their time), in each case, which material change would reasonably be expected to adversely impact (i) Anima's ability to perform its obligations under this Agreement or (ii) the Exploitation of any Royalty-Bearing Compound or Royalty-Bearing Product by AbbVie, its Affiliates, or its Sublicensees. Without limiting the foregoing, Anima shall ensure that, if such Change of Control occurs prior to the expiration of the last-to-expire Collaboration Term, the efforts and resources expended by Anima and its Affiliates with respect to the performance of activities under any Collaboration Plan will not decline following such Change of Control, and without limiting the foregoing, (A) the number and qualification of the employees and consultants of Anima or any of its Affiliates tasked with carrying out activities under any Collaboration Plan will be substantially equivalent to the number and qualification of those employed or engaged prior to such Change of Control, and (B) each employee or consultant of Anima or any of its Affiliates tasked with performing activities under any Collaboration Plan during the six- (6-) month period immediately prior to such Change of Control or who would reasonably be expected to perform activities under such Collaboration Plan after such Change of Control, shall continue to conduct the applicable activities under such Collaboration Plan after such Change of Control until the date the applicable activities that such employee or consultant is tasked with performing are completed in accordance with the terms of this Agreement, for so long as such Person remains an employee or consultant of Anima or any of its Affiliates and solely to the extent that performing such activities remains within the scope of the employee's or consultant's employment or engagement.", "": "" }, { "Text": "ARTICLE 9 INTELLECTUAL PROPERTY RIGHTS", "": "" }, { "Text": "9.1 Ownership of Intellectual Property; Disclosure.", "": "" }, { "Text": "9.1.1 Ownership. Subject to the license grants and other rights herein, as between the Parties: (a) all right, title, and interest in and to all (i) Know-How that is conceived, reduced to practice, generated, discovered, developed, or otherwise made solely by or on behalf of Anima (or its Affiliates) in the course of activities conducted pursuant to this Agreement, and any and all Patent Rights and other intellectual property rights with respect thereto, and (ii) Anima Improvements, in each case ((i) and (ii)) shall be owned by Anima; and (b) all right, title, and interest in and to all Know-How that is conceived, reduced to practice, generated, discovered, developed, or otherwise made solely by or on behalf of AbbVie (or its Affiliates) in the course of activities conducted pursuant to this Agreement, and any and all Patent Rights and other intellectual property rights with respect thereto, shall be owned by AbbVie (for clarity, including its designated Affiliates).", "": "" }, { "Text": "9.1.2 United States Law. The determination of whether Know-How is conceived, reduced to practice, generated, discovered, developed, or otherwise made by or on behalf of a Party or its Affiliates for the purpose of allocating proprietary rights (including patent, copyright, or other intellectual property rights) therein, shall, for purposes of this Agreement, be made in accordance with United States patent law and other applicable Law in the United States without regard to conflict of law, irrespective of where or when such conception, reduction to practice, generation, discovery, development, or making occurs. In the event that United States law otherwise would not apply to the conception, reduction to practice, generation, discovery, development, or making of any Know-How hereunder, each Party shall, and does hereby, assign, and shall cause its Affiliates to so assign, to the other Party, without additional compensation, such right, title, and interest in and to any Know-How as well as any intellectual property rights with respect thereto, as is necessary to fully effect the applicable sole ownership provided for in Section 9.1.1 (Ownership).", "": "" }, { "Text": "9.1.3 Disclosure of Inventions. During the Term, Anima shall, and shall cause its Affiliates, subcontractors, and (sub)licensees to, promptly disclose in writing to AbbVie the conception, reduction to practice, generation, discovery, development, or making of any Collaboration Know-How by Anima or any of its Affiliates, subcontractors, or (sub)licensees.", "": "" }, { "Text": "9.1.4 Control of Intellectual Property. Anima and its Affiliates shall not enter into or amend any agreement with a Third Party, or include in any such agreement or amendment any restrictive provisions, that limit its Control of any Licensed IP that would be subject to the license grants in Section 4.1 (Licenses to AbbVie) in the absence of such agreement, amendment, or restrictive provisions. Further, when entering into any agreement or amendment with a Third Party relating to any Licensed IP that, if Controlled by Anima, would be subject to the license Anima grants in Section 4.1 (Licenses to AbbVie), and without limiting Section 2.8 (IP Assignment Obligation), Anima shall use Commercially Reasonable Efforts to obtain Control of such Know-How, Patent Rights, and other intellectual property rights.", "": "" }, { "Text": "9.2 AbbVie Patents. AbbVie shall have the sole right, but not the obligation, to prepare, file, prosecute, defend, maintain, and enforce any Patent Right which covers, among other matters, Know-How owned or otherwise controlled by AbbVie or its Affiliates pertaining to Royalty-Bearing Compounds, Royalty-Bearing Products, or the Exploitation thereof, including Patent Rights which relate to the composition of matter, manufacture, use, formulation, dosing, and dosing regimens of Royalty-Bearing Compounds or Royalty-Bearing Products.", "": "" }, { "Text": "9.3 Patent Prosecution and Maintenance.", "": "" }, { "Text": "9.3.1 Anima Prosecution of Collaboration Patents. During the Term, neither Anima nor its Affiliates will, or will enable any Third Party without AbbVie's prior written approval to, prepare, file, or prosecute any patent application within the Collaboration Patents or otherwise relating to Collaboration Know-How, other than Patent Rights to the extent they claim Anima Improvements.", "": "" }, { "Text": "9.3.2 AbbVie Prosecution of Anima Collaboration Patents. Promptly following the License Option Effective Date with respect to a Target Program Slot: (a) Anima shall provide AbbVie with all reasonable assistance and cooperation for AbbVie to assume responsibility for and control over the preparation, filing, prosecution, defense, and maintenance of the Anima Collaboration Patents that are subject to the applicable AbbVie License worldwide (including any Anima Collaboration Patent that claims any Know-How in the License Option Exercise Data Package, any Royalty-Bearing Compound, any Royalty-Bearing Product, any composition containing a Royalty-Bearing Compound, or Exploitation of any of the foregoing); and (b) AbbVie shall have the sole and exclusive right, but not the obligation, to prepare, file, prosecute, defend, and maintain such Anima Collaboration Patents worldwide, at AbbVie's sole cost and expense, in accordance with the terms of this Section 9.3.2 (AbbVie Prosecution of Anima Collaboration Patents).", "": "" }, { "Text": "9.3.3 Anima Improvement Patents. Anima shall have the sole and exclusive right, but not the obligation, to prepare, file, prosecute, defend, and maintain the Anima Improvement Patents worldwide, at Anima's sole cost and expense.", "": "" }, { "Text": "9.3.4 Cooperation. Anima agrees to cooperate fully with AbbVie in the preparation, filing, prosecution, defense, and maintenance of the Anima Collaboration Patents, at its own cost and expense. Such cooperation shall include:", "": "" }, { "Text": "(a) executing all papers and instruments, or requiring its employees or contractors to execute such papers and instruments, as applicable, so as to: (i) effectuate the ownership of intellectual property set forth in Section 9.1 (Ownership of Intellectual Property; Disclosure); (ii) enable AbbVie to apply for and to prosecute patent applications in the Territory; and (iii) enable AbbVie to obtain and maintain any patent extensions, supplementary protection certificates, and the like with respect to the Anima Collaboration Patents in the Territory, in each case ((i), (ii), and (iii)) to the extent provided for in this Agreement;", "": "" }, { "Text": "(b) consistent with this Agreement, assisting in any license registration processes with applicable Governmental Authorities that may be available in the Territory for the protection of a Party's interests in this Agreement; and", "": "" }, { "Text": "(c) promptly informing AbbVie of any matters coming to Anima's attention that may materially affect the preparation, filing, prosecution, defense, or maintenance of any such Anima Collaboration Patents in the Territory.", "": "" }, { "Text": "9.3.5 Patent Term Extension and Supplementary Protection Certificate. AbbVie shall have the sole right to make decisions regarding, and AbbVie shall have the sole right to apply for, patent term extensions in the Territory, including in the United States with respect to extensions pursuant to 35 U.S.C. § 156 et. seq. and in other jurisdictions pursuant to supplementary protection certificates, and in all jurisdictions with respect to any other extensions (including pediatric extensions) that are now or become available in the future, wherever applicable, for Anima Collaboration Patents, in each case including whether or not to so apply.", "": "" }, { "Text": "9.3.6 Patent Listings. AbbVie shall have the sole right to determine and make all patent listings and filings with Governmental Authorities in the Territory with respect to the Anima Collaboration Patents.", "": "" }, { "Text": "9.4 Enforcement of Licensed IP.", "": "" }, { "Text": "9.4.1 Enforcement. Each Party shall promptly notify the other Party in writing of any alleged or threatened infringement of the Licensed IP by a Third Party in the Territory of which such Party becomes aware based on the development, commercialization, or other exploitation of, or an application to register or market, a product containing a Royalty-Bearing Compound or any Royalty-Bearing Product (including a Generic Product) in the Territory (\"Product Infringement\"). Following the License Option Effective Date with respect to a Target Program Slot, AbbVie (as used in this Section 9.4 (Enforcement of Licensed IP), including its designated Affiliate, if applicable) shall have the sole and exclusive right, but not the obligation, to prosecute or settle any Product Infringement, at AbbVie's sole cost and expense, using counsel of its own choice. Anima shall where necessary, join in, or be named as a necessary party to, such action, at its own expense; provided that AbbVie shall retain control of the prosecution and settlement of such claim, suit, or proceeding.", "": "" }, { "Text": "9.4.2 Recovery. Unless otherwise agreed by the Parties in writing, the amount of any recovery from a proceeding brought under Section 9.4.1 (Enforcement) (whether by way of settlement or otherwise) shall first be applied to the internal and out-of-pocket costs and expenses of the Parties with respect to such action (which amounts shall be allocated first to AbbVie if insufficient to cover the totality of such expenses), and any remaining recovery amount shall thereafter be retained by AbbVie; provided, however, that to the extent that any amount in an award or settlement (whether by judgment or otherwise) is attributable to loss of sales or profits with respect to a Royalty-Bearing Product, such amount shall be paid to or retained by AbbVie and after deduction of the Parties' internal and out-of-pocket costs and expenses with respect to such action treated as \"Net Sales\" in the Calendar Year in which the money is actually received and any royalties pursuant to Section 7.8 (Royalties) shall be payable by AbbVie to Anima with respect thereto.", "": "" }, { "Text": "9.5 Infringement Claims by Third Parties. If the Manufacture, sale, or use of a Royalty-Bearing Compound or Royalty-Bearing Product in the Territory pursuant to this Agreement results in, or may result in, any claim, suit, or proceeding by a Third Party alleging infringement by a Party (or its Affiliates) (a \"Third Party Infringement Claim\"), then such Party shall promptly notify the other Party thereof in writing. Unless the Party against whom a Third Party Infringement Claim is filed seeks indemnification for such Third Party Infringement Claim that is covered pursuant to ARTICLE 12 (Indemnification; Insurance), as between the Parties, the alleged infringing Party shall have the right, but not the obligation, at its sole cost and expense, using counsel of its own choice, to control the defense and settlement of any Third Party Infringement Claim. Where a Party controls such an action, the other Party shall, and shall cause its Affiliates to, assist and cooperate with the controlling Party, as such controlling Party may reasonably request from time to time, in connection with its activities set forth in this Section 9.5 (Infringement Claims by Third Parties), including: executing legal papers and cooperating in the defense; furnishing a power of attorney solely for such purpose; joining in, or being named as a necessary party to, such action; providing access to relevant documents and other evidence; and, in the case of Anima, making available its employees as well as inventors, applicable records, and documents (including laboratory notebooks) with respect to the relevant Licensed IP; provided that the controlling Party shall reimburse such other Party for its reasonable and verifiable out-of-pocket costs and expenses incurred in connection therewith. Where Anima is the controlling Party, Anima shall keep AbbVie reasonably informed of all material developments in connection with any such claim, suit, or proceeding. Any recoveries by a Party of any sanctions awarded to such Party and against a Third Party asserting a Third Party Infringement Claim shall be applied as follows: such recovery shall be applied first to reimburse each Party for its reasonable out-of-pocket costs and expenses of defending such claim, suit, or proceeding (which amounts shall be allocated first to the controlling Party if insufficient to cover the totality of such expenses), and the balance shall be retained by the Party controlling the defense of such Third Party Infringement Claim. AbbVie shall be entitled to offset up to fifty percent (50%) of the reasonable out-of-pocket costs of defending a claim, suit, or proceeding under this Section 9.5 (Infringement Claims by Third Parties) in a given Calendar Quarter from any of (a) AbbVie's milestone payments under Section 7.6 (Development and Regulatory Milestone Payments) or Section 7.7 (Sales-Based Milestone Payments) or (b) AbbVie's royalty payments under Section 7.8.1 (Royalty Rates), in each case for such Calendar Quarter, with the balance then remaining to be carried over to milestone payments and royalties due with respect to subsequent Calendar Quarters.", "": "" }, { "Text": "9.6 Invalidity or Unenforceability Defenses or Actions.", "": "" }, { "Text": "9.6.1 Notice. Each Party shall promptly notify the other Party in writing of any alleged or threatened assertion of invalidity or unenforceability of any of the Anima Collaboration Patents by a Third Party, in each case in the Territory and of which such Party becomes aware.", "": "" }, { "Text": "9.6.2 Anima Collaboration Patents. Following the License Option Effective Date with respect to a Target Program Slot, AbbVie shall have the sole and exclusive right, but not the obligation, to defend and control the defense of the validity, patentability, and enforceability of all Anima Collaboration Patents at its own cost and expense in the Territory.", "": "" }, { "Text": "9.6.3 Cooperation. Anima shall assist and cooperate with AbbVie as AbbVie may reasonably request from time to time in connection with its activities set forth in this Section 9.6 (Invalidity or Unenforceability Defenses or Actions), including by providing access to relevant documents and other evidence, and making its employees available at reasonable business hours.", "": "" }, { "Text": "9.6.4 Costs and Expenses. AbbVie shall be entitled to offset up to fifty percent (50%) of the reasonable out-of-pocket costs of defending a claim, suit, or proceeding under this Section 9.6 (Invalidity or Unenforceability Defenses or Actions) in a given Calendar Quarter from any of (a) AbbVie's milestone payments under Section 7.6 (Development and Regulatory Milestone Payments) or Section 7.7 (Sales-Based Milestone Payments) or (b) AbbVie's royalty payments under Section 7.8 (Royalties), in each case for such Calendar Quarter, with the balance then remaining to be carried over to milestone payments and royalties due with respect to subsequent Calendar Quarters.", "": "" }, { "Text": "9.7 Third Party Licenses. If in the reasonable opinion of AbbVie, the Development, Manufacture, Commercialization, or other Exploitation of any Royalty-Bearing Compound or Royalty-Bearing Product by AbbVie, any of its Affiliates, or any of its or their Sublicensees infringes or misappropriates any Patent Right, trade secret, or other intellectual property right of a Third Party in any country or other jurisdiction in the Territory, such that AbbVie, any of its Affiliates, or any of its or their Sublicensees cannot Develop, Manufacture, Commercialize, or otherwise Exploit such Royalty-Bearing Compound or Royalty-Bearing Product in such country or other jurisdiction without infringing or misappropriating such Patent Right, trade secret, or other intellectual property right of such Third Party, then, unless otherwise mutually agreed by the Parties in writing, AbbVie shall have the sole right, but not the obligation, to negotiate and obtain a license from such Third Party as necessary for AbbVie and its Affiliates, and its and their Sublicensees to Develop, Manufacture, Commercialize, and Exploit such Royalty-Bearing Compound and Royalty-Bearing Product in such country or other jurisdiction. In the event that AbbVie negotiates and obtains any such license from a Third Party, AbbVie shall be entitled to deduct amounts payable to such Third Parties from the milestone payments and royalties payable to Anima under this Agreement in accordance with Section 7.10.2 (Stacking) and Section 7.10.4 (Mechanics of Adjustment to Royalties and Milestones).", "": "" }, { "Text": "9.8 Product Trademarks. Following AbbVie's exercise of the applicable License Option, as between the Parties, AbbVie shall have the sole and exclusive right to determine and shall own all right, title, and interest in and to the Trademarks that are used in connection with any Royalty-Bearing Product anywhere in the world.", "": "" }, { "Text": "9.9 Inventor's Remuneration. Each Party shall be solely responsible for any remuneration that may be due such Party's inventors under any applicable inventor remuneration laws, including under Section 134 of the Israeli Patent Law-1967.", "": "" }, { "Text": "9.10 International Nonproprietary Name. As between the Parties, AbbVie shall have the sole right and responsibility to select the International Nonproprietary Name or other name or identifier for any Royalty-Bearing Compound or Royalty-Bearing Product. AbbVie shall have the sole right and responsibility to apply for submission to the World Health Organization for the International Nonproprietary Name, and submission to the United States Adopted Names Council for the United States Adopted Name.", "": "" }, { "Text": "ARTICLE 10 CONFIDENTIALITY", "": "" }, { "Text": "10.1 Product Information. Anima recognizes that by reason of AbbVie's rights under this Agreement, AbbVie has an interest in Anima's maintaining the confidentiality of certain information of Anima. Accordingly, during the Term, Anima shall, and shall cause its Affiliates and its and their respective officers, directors, employees, and agents to, keep completely confidential, and not publish or otherwise disclose, and not use directly or indirectly for any purpose other than to fulfill Anima's obligations hereunder, any Confidential Information or Know-How owned or Controlled by Anima or any of its Affiliates relating to (a) the Licensed IP, provided that the Anima Platform Technology, Anima Background Know-How, and Anima Improvements will not be deemed to be Confidential Information or Know-How relating to the Licensed IP, (b) any License Option Exercise Data Package and information therein related to ADCs (other than any ADCs that were designated Excluded ADCs in accordance with Section 2.7.5 (Anima Discovered Compounds)) or Credentialed MoA Targets, (c) any Collaboration Target or Reserved Target (with respect to Reserved Targets, solely for the duration of Anima's exclusivity obligation with respect to such Reserved Targets as set forth in Section 8.1.1(a) (Reserved Targets)), or (d) to the extent disclosed by AbbVie to Anima, any Royalty-Bearing Compound or Royalty-Bearing Product, or the Exploitation of any of the foregoing ((a)-(d), the \"Product Information\"); except to the extent (i) the Product Information is in the public domain through no fault of Anima, its Affiliates, or any of its or their respective officers, directors, employees, or agents; (ii) such disclosure or use is expressly permitted under Section 10.3 (Permitted Disclosures); or (iii) such disclosure or use is otherwise expressly permitted by the terms of this Agreement. For purposes of the confidentiality and non-use obligations under this ARTICLE 10 (Confidentiality), AbbVie shall be deemed to be the disclosing Party with respect to Product Information and Anima shall be deemed to be the receiving Party with respect thereto. Without limiting this Section 10.1 (Product Information), to the extent Product Information is disclosed by Anima to AbbVie pursuant to this Agreement, such information shall, subject to the other terms and conditions of this ARTICLE 10 (Confidentiality), (A) before the License Option Effective Date with respect to such Product Information, also constitute Confidential Information of Anima with respect to the use and disclosure of such Product Information by Anima (and Anima shall be deemed to be the disclosing Party and AbbVie shall be deemed to be the receiving Party with respect thereto) and (B) after the License Option Effective Date with respect to such Product Information, such Product Information shall constitute the Confidential Information solely of AbbVie with respect to the use and disclosure of such information (and Anima shall be deemed to be the receiving Party and AbbVie shall be deemed to be the disclosing party with respect thereto). The disclosure by Anima to AbbVie of Product Information shall not cause such information to cease to be subject to the provisions of this Section 10.1 (Product Information) with respect to the use and disclosure of such Confidential Information by Anima. In the event this Agreement is terminated in its entirety or with respect to a Royalty-Bearing Product, country, or Collaboration Target, this Section 10.1 (Product Information) shall have no continuing force or effect with respect to the use or disclosure of such information solely in connection with (x) the Exploitation of the terminated Royalty-Bearing Product, (y) the Exploitation of the Royalty-Bearing Compounds or Royalty-Bearing Products with respect to the Terminated Target, or (z) the Exploitation of all Royalty-Bearing Compounds or Royalty-Bearing Products for the benefit of the Terminated Territory, as applicable, but the Product Information, to the extent disclosed by AbbVie to Anima hereunder, shall continue to be Confidential Information of AbbVie, subject to the terms of Sections 10.2 (Confidentiality Obligations), 10.3 (Permitted Disclosures), and 10.6 (Publications) for purposes of the surviving provisions of this Agreement.", "": "" }, { "Text": "10.2 Confidentiality Obligations. At all times during the Term and for a period of ten (10) years following termination or expiration of this Agreement in its entirety, each Party shall, and shall cause its officers, directors, employees, and agents to, keep confidential and not publish or otherwise disclose to a Third Party and not use, directly or indirectly, for any purpose, the Confidential Information furnished or otherwise made known to it, directly or indirectly, by the other Party, except to the extent such disclosure or use is expressly permitted by the terms of this Agreement or is necessary or reasonably useful for the performance of, or the exercise of such Party's rights under, this Agreement. Notwithstanding the foregoing, to the extent the receiving Party can demonstrate by documentation or other competent proof, the confidentiality and non-use obligations under this Section 10.2 (Confidentiality Obligations) with respect to any Confidential Information shall not include any information that:", "": "" }, { "Text": "10.2.1 has been published by a Third Party or otherwise is or hereafter becomes part of the public domain by public use, publication, general knowledge, or the like through no wrongful act, fault, or negligence on the part of the receiving Party;", "": "" }, { "Text": "10.2.2 had been in the receiving Party's possession prior to disclosure by the disclosing Party without any obligation of confidentiality with respect to such information; provided that the foregoing exception shall not apply with respect to Regulatory Filings;", "": "" }, { "Text": "10.2.3 is subsequently received by the receiving Party from a Third Party without restriction and without breach of any agreement between such Third Party and the disclosing Party;", "": "" }, { "Text": "10.2.4 is generally made available to Third Parties by the disclosing Party without restriction on disclosure; or", "": "" }, { "Text": "10.2.5 has been independently developed by or for the receiving Party without reference to, or use or disclosure of, the disclosing Party's Confidential Information; provided that the foregoing exception shall not apply with respect to Regulatory Filings.", "": "" }, { "Text": "Specific aspects or details of Confidential Information shall not be deemed to be within the public domain or in the possession of the receiving Party merely because the Confidential Information is embraced by more general information in the public domain or in the possession of the receiving Party. Further, any combination of Confidential Information shall not be considered in the public domain or in the possession of the receiving Party merely because individual elements of such Confidential Information are in the public domain or in the possession of the receiving Party unless the combination is in the public domain or in the possession of the receiving Party.", "": "" }, { "Text": "10.3 Permitted Disclosures.", "": "" }, { "Text": "10.3.1 Each Party may disclose the Confidential Information of the other Party to the extent that such disclosure is:", "": "" }, { "Text": "(a) in the reasonable opinion of the receiving Party's legal counsel, required to be disclosed pursuant to law, regulation, or a valid order of a court of competent jurisdiction or other supra-national, federal, national, regional, state, provincial, and local governmental body of competent jurisdiction (including by reason of filing with securities regulators, but subject to Section 10.5 (Public Announcements)); provided that the receiving Party shall first have given prompt written notice (and to the extent possible, at least five (5) Business Days' notice) to the disclosing Party and given the disclosing Party a reasonable opportunity to take whatever action it deems necessary to protect its Confidential Information (for example, to quash such order or to obtain a protective order or confidential treatment requiring that the Confidential Information and documents that are the subject of such order be held in confidence by such court or governmental body or, if disclosed, be used only for the purposes for which the order was issued). In the event that no protective order or other remedy is obtained, or the disclosing Party waives compliance with the terms of this Agreement, the receiving Party shall furnish only that portion of Confidential Information that the receiving Party is advised by counsel is legally required to be disclosed;", "": "" }, { "Text": "(b) made by or on behalf of the receiving Party to the Regulatory Authorities as required in connection with any filing, application, or request for any Regulatory Approval in accordance with the terms of this Agreement; provided that the receiving Party shall take reasonable measures to assure confidential treatment of such Confidential Information to the extent practicable and consistent with applicable Law; or", "": "" }, { "Text": "(c) made by or on behalf of the receiving Party to a patent authority as may be necessary or reasonably useful for purposes of preparing, obtaining, defending, or enforcing a Patent Right in accordance with the terms of this Agreement; provided that the receiving Party shall take reasonable measures to assure confidential treatment of such Confidential Information, to the extent such protection is available.", "": "" }, { "Text": "10.3.2 AbbVie or its Affiliates or Sublicensees may disclose the Confidential Information of Anima to its or their advisors, consultants, clinicians, vendors, service providers, contractors, existing or prospective collaboration partners, licensees, sublicensees, or other Third Parties as may be necessary or useful in connection with the Exploitation of the Royalty-Bearing Compounds or Royalty-Bearing Products, or otherwise in connection with the performance of its obligations or exercise of its rights as contemplated by this Agreement; provided that such Persons shall be subject to obligations of confidentiality and non-use with respect to such Confidential Information that are no less restrictive than the obligations of confidentiality and non-use of the receiving Party pursuant to this ARTICLE 10 (Confidentiality); provided, however, that the duration of confidentiality and non-use obligations shall be no less than five (5) years from the date of disclosure for advisors, consultants, clinicians, vendors, service providers, and contractors.", "": "" }, { "Text": "10.3.3 Anima or its Affiliates may, after receiving advance approval from AbbVie, such approval not to be unreasonably withheld, conditioned, or delayed, disclose the Confidential Information of AbbVie to its advisors, consultants, clinicians, vendors, service providers, contractors, and the like to the extent necessary for the performance of Anima's activities contemplated by this Agreement; provided that such Persons shall be subject to obligations of confidentiality and non-use with respect to such Confidential Information of AbbVie that are no less restrictive than the obligations of confidentiality and non-use of Anima pursuant to this ARTICLE 10 (Confidentiality).", "": "" }, { "Text": "10.3.4 Each Party may disclose the existence and terms of this Agreement to the extent that such disclosure is:", "": "" }, { "Text": "(a) made by the receiving Party (and where the receiving Party is AbbVie, its Affiliates) to their respective financial and external legal advisors who have a need to know the existence and terms of this Agreement and are either under professional codes of conduct giving rise to expectations of confidentiality and non-use or under written agreements of confidentiality and non-use, in each case, no less restrictive than the obligations of confidentiality and non-use of the receiving Party pursuant to this ARTICLE 10 (Confidentiality); provided that the receiving Party shall remain responsible for any failure by such financial and external legal advisors to treat such Confidential Information as required under this ARTICLE 10 (Confidentiality); or", "": "" }, { "Text": "(b) made by the receiving Party (and where the receiving Party is AbbVie, its Affiliates) to potential or actual investors or acquirers as may be necessary in connection with their evaluation of a potential or actual investment or acquisition; provided that such Persons shall be subject to obligations of confidentiality and non-use with respect to such Confidential Information that are no less restrictive than the obligations of confidentiality and non-use of the receiving Party pursuant to this ARTICLE 10 (Confidentiality).", "": "" }, { "Text": "10.3.5 Notwithstanding any provision to the contrary in this Agreement, Anima shall not, and shall cause its Affiliates not to, disclose any Collaboration Target or Reserved Target to any Third Party except (a) to a Third Party subcontractor of Anima solely for the purpose of performing activities under this Agreement or (b) through a gatekeeping process substantially similar to the gatekeeping process set forth in Sections 2.4 (Gatekeeper) and 2.5 (Selection of Available Targets) and otherwise reasonably acceptable to AbbVie, solely to the extent necessary for Anima to comply with its obligations under this Agreement. Notwithstanding any provision to the contrary in this Agreement, Anima shall not, and shall cause its Affiliates not to, disclose to any Third Party that any Collaboration Target or Reserved Target was evaluated pursuant to a collaboration with AbbVie.", "": "" }, { "Text": "10.4 Use of Name. Except as expressly provided herein, neither Party shall mention or otherwise use the name, logo, or Trademark of the other Party or any of its Affiliates (or any abbreviation or adaptation thereof) in any publication, press release, marketing and promotional material, or other form of publicity without the prior written approval of such other Party in each instance. The restrictions imposed by this Section 10.4 (Use of Name) shall not prohibit either Party from making any disclosure identifying the other Party that, in the opinion of the disclosing Party's counsel, is required by applicable Law; provided that such Party shall submit the proposed disclosure identifying the other Party in writing to the other Party as far in advance as reasonably practicable so as to provide a reasonable opportunity to comment thereon.", "": "" }, { "Text": "10.5 Public Announcements. The Parties have agreed upon the content of a press release which shall be issued substantially in the form attached hereto as Schedule 10.5 (Public Announcement), the release of which the Parties shall coordinate in order to accomplish such release at a time mutually agreed by the Parties. Neither Party shall issue any other public announcement, press release, or other public disclosure regarding this Agreement or its subject matter without the other Party's prior written consent, except for any such disclosure by AbbVie that is, in the opinion of its counsel, required by applicable Law or the rules of a stock exchange on which the securities of AbbVie are listed. In the event that AbbVie is, in the opinion of its counsel, required by applicable Law or the rules of a stock exchange on which its securities are listed to make such a public disclosure, AbbVie shall submit the proposed disclosure (together with the reasons for the disclosure requirement and notification of the time and place where the disclosure shall be made) in writing to Anima as far in advance as reasonably practicable so as to provide a reasonable opportunity for Anima to review and comment thereon. In the event that Anima becomes a publicly traded company, then commencing with Anima's initial application to become a listed company on a stock exchange, the foregoing rights in this Section 10.5 (Public Announcements) of AbbVie regarding disclosure required by applicable Law or the rules of a stock exchange on which its securities are listed shall also apply to Anima, mutatis mutandis. Notwithstanding the foregoing, AbbVie and its Affiliates and Sublicensees, shall have the right to publicly disclose research, development, and commercial information (including with respect to regulatory matters) regarding the Royalty-Bearing Compounds and Royalty-Bearing Products; provided that (a) such disclosure shall be subject to the provisions of ARTICLE 10 (Confidentiality) with respect to Anima's Confidential Information and (b) AbbVie shall not use the name of Anima (or insignia, or any contraction, abbreviation, or adaptation thereof) without Anima's prior written permission.", "": "" }, { "Text": "10.6 Publications. Anima shall not publish, present, or otherwise disclose, and shall cause its Affiliates and any Third Party subcontractors and its and their employees and agents not to disclose any information relating to (a) any activities under a Collaboration Plan (including, for clarity, any lead generation activities under any Collaboration Plan), (b) any Reserved Target (solely for the duration of Anima's exclusivity obligation with respect to such Reserved Targets as set forth in Section 8.1.1(a) (Reserved Targets)), (c) any Collaboration Target, (d) any mechanism of action with respect to the biology of any Collaboration Target, or (e) any Royalty-Bearing Compound or Royalty-Bearing Product, in each case without the prior written consent of AbbVie. Following any License Option Effective Date, AbbVie shall have the right to freely publish, present, or otherwise disclose any material related to the applicable Collaboration Plan (including the License Option Exercise Data Package) or the Exploitation of Royalty-Bearing Compounds or Royalty-Bearing Products.", "": "" }, { "Text": "10.7 Return of Confidential Information. Upon the effective date of the termination of this Agreement for any reason, either Party may request in writing, and the other Party shall either, with respect to Confidential Information (in the event of termination of this Agreement with respect to one (1) or more Terminated Territories, Terminated Products, or Terminated Targets but not in its entirety, solely to the extent relating specifically and exclusively to such Terminated Territories, Terminated Products, or Terminated Targets) to which such first Party does not retain rights under the surviving provisions of this Agreement: (a) as soon as reasonably practicable, destroy all copies of such Confidential Information in the possession of the other Party and confirm such destruction in writing to the requesting Party; or (b) as soon as reasonably practicable, deliver to the requesting Party, at the other Party's expense, all copies of such Confidential Information in the possession of the other Party; provided that the other Party shall be permitted to retain one (1) copy of such Confidential Information for the sole purpose of performing any continuing obligations hereunder, as required by applicable Law, or for archival purposes. Notwithstanding the foregoing, such other Party also shall be permitted to retain such additional copies of or any computer records or files containing such Confidential Information that have been created solely by such Party's automatic archiving and back-up procedures, to the extent created and retained in a manner consistent with such other Party's standard archiving and back-up procedures, but not for any other use or purpose.", "": "" }, { "Text": "10.8 Survival. All Confidential Information shall continue to be subject to the terms of this Agreement for the period set forth in Section 10.2 (Confidentiality Obligations).", "": "" }, { "Text": "ARTICLE 11 REPRESENTATIONS AND WARRANTIES", "": "" }, { "Text": "11.1 Representations and Warranties of Both Parties. Each Party hereby represents and warrants to the other Party, as of the Effective Date, that:", "": "" }, { "Text": "11.1.1 such Party is duly organized, validly existing, and in good standing under the Laws of the jurisdiction of its incorporation and has full corporate power and authority to enter into this Agreement and to carry out the provisions hereof;", "": "" }, { "Text": "11.1.2 such Party has taken all necessary action on its part to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder;", "": "" }, { "Text": "11.1.3 this Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, and binding obligation, enforceable against it in accordance with the terms hereof, subject to the effects of bankruptcy, insolvency, or other laws of general application affecting the enforcement of creditor rights, judicial principles affecting the availability of specific performance, and general principles of equity (whether enforceability is considered a proceeding at law or equity);", "": "" }, { "Text": "11.1.4 the execution, delivery, and performance of this Agreement by such Party do not conflict with and do not violate: (a) such Party's charter documents, bylaws, or other organizational documents; (b) in any material respect, any agreement or any provision thereof, or any instrument or understanding, oral or written, to which it is a party or by which it is bound; (c) any applicable Law; or (d) any order, writ, judgment, injunction decree, determination, or award of any court, governmental body, or administrative or other agency having jurisdiction over such Party; and", "": "" }, { "Text": "11.1.5 it is not under any obligation, contractual or otherwise, to any Person that conflicts with or is inconsistent in any material respect with the terms of this Agreement or that would impede the diligent and complete fulfillment of its obligations hereunder.", "": "" }, { "Text": "11.2 Representations, Warranties, and Covenants, as applicable, of Anima. Anima hereby represents, warrants, and covenants, as applicable, to AbbVie, as of (a) the Effective Date, and (b) the date(s) on which AbbVie exercises a License Option, except in each case ((a) and (b)) as set forth in the corresponding section of Schedule 11.2 (Anima Disclosure Schedule) or the updated disclosure schedule delivered by Anima to AbbVie under Section 2.9.3(b) (Exercise of License Option):", "": "" }, { "Text": "11.2.1 Other than (a) Anima Biotech Ltd., a company incorporated in Israel and, (b) Anima Biotech DMCC, a company incorporated in the United Arab Emirates and (c) Anima Biotech UK Limited, a company incorporated in the United Kingdom, Anima has never had and does not as of such date have any Affiliates. True, complete, and correct copies (with appropriate redactions) of all agreements between Anima and its Affiliates have been provided to AbbVie. Anima has written agreements with each of its Affiliates that automatically assign to Anima all of such Affiliate's rights, title, and interest in and to any inventions and discoveries made, developed, or conceived by such Affiliates during the course of performing services for Anima;", "": "" }, { "Text": "11.2.2 Anima (a) has the right to grant the licenses specified herein and (b) has the right to use all Anima Background Know-How and Anima Background Patents necessary for Anima to fulfill its obligations hereunder;", "": "" }, { "Text": "11.2.3 Anima solely owns the Anima Background Know-How and Anima Background Patents. As of the Effective Date, there are no licenses or other agreements between Anima or its Affiliate, on one hand, and a Third Party, on the other hand, under which AbbVie is granted a sublicense or other right under this Agreement, including under any Anima Background Patents and Anima Background Know-How.", "": "" }, { "Text": "11.2.4 The In-License Agreements do not and will not create any obligation upon AbbVie to any Third Party. No license or agreement to which Anima or any of its Affiliates is a party creates or imposes any financial obligation upon AbbVie to a Third Party. There are no amounts that will be required to be paid to a Third Party by AbbVie or any of its Affiliates as a result of the Exploitation of any Royalty-Bearing Compound or Royalty-Bearing Product that arise out of any agreement to which Anima or any of its Affiliates is a party.", "": "" }, { "Text": "11.2.5 All Anima Background Patents existing as of such date (the \"Existing Patent Rights\") are listed on Schedule 1.13 (Existing Patents), and all issued patents included in the Existing Patent Rights are (a) subsisting and are not invalid or unenforceable, in whole or in part, (b) solely and exclusively owned or licensed by Anima or one of its Affiliates, free of any encumbrance, lien, or claim of ownership by any Third Party, and (c) filed and maintained properly and correctly and all applicable fees have been paid on or before the due date for payment. The pending applications included in the Existing Patent Rights are being diligently prosecuted in the respective patent offices in the Territory in accordance with applicable Law and solely to the extent required under applicable Law (including applicable rules of a patent office), Anima and its Affiliates have presented all relevant references, documents, and information of which it and the inventors are aware to the relevant patent examiner at the relevant patent office;", "": "" }, { "Text": "11.2.6 To Anima's Knowledge, no compound in the Anima Compound Library has been included in any unblinded compound library screened by or on behalf of Anima or its Affiliates prior to the Effective Date;", "": "" }, { "Text": "11.2.7 True, complete, and correct copies of all In-License Agreements (subject to redaction of confidential and commercially sensitive information that is not relevant for AbbVie to determine its rights and obligations hereunder) have been provided to AbbVie;", "": "" }, { "Text": "11.2.8 All of the Existing In-License Agreements existing as of the Effective Date are listed on Schedule 1.72 (Existing In-License Agreements) and (a) the licenses granted to Anima or its Affiliates in the In-License Agreements are in full force and effect, (b) to Anima's Knowledge, there are no challenges to or violation of the rights granted to Anima or its Affiliates thereunder by any Third Party, (c) Anima or its Affiliate, if applicable, is not in breach under any of the In-License Agreements, nor, to Anima's Knowledge, is any counterparty thereto, (d) neither Anima nor any of its Affiliates has received any written notice of breach under any of the In-License Agreements from the counterparty thereto, (e) to Anima's Knowledge, no facts or circumstances exist that would reasonably be expected by Anima to give rise to an such challenge, violation, or breach, and (f) this Agreement is fully consistent with and does not constitute a breach of any In-License Agreement. During the Term, Anima shall not, and shall cause its Affiliates not to, encumber or diminish the rights granted to AbbVie hereunder with respect to any of Anima's Patent Rights that are the subject of the AbbVie License, including by amending or terminating any In-License Agreement. During the Term, Anima shall not, and shall cause its Affiliates not to, commit any acts or permit the occurrence of any omissions that would cause breach or termination of any In-License Agreement that would modify AbbVie's rights (including through affecting Anima's ability to conduct its obligations) hereunder as of the time of such act, failure to act, breach, or termination. Anima shall promptly provide AbbVie with notice of any alleged, threatened, or actual breach of any In-License Agreement that would modify AbbVie's rights (including through affecting Anima's ability to conduct its obligations) hereunder as of the time of such alleged, threatened, or actual breach. All In-License Agreements under which AbbVie receives or is to receive rights under this Agreement do, and shall, contain a provision requiring Anima's grant of rights to AbbVie under the relevant intellectual property pursuant to this Agreement to survive on the terms of this Agreement to the extent such terms are applicable to such rights;", "": "" }, { "Text": "11.2.9 The Existing Patent Rights represent all Patent Rights that Anima or its Affiliates own or Control that claim any Anima Background Know-How that Anima intends to use in conducting its obligations under this Agreement;", "": "" }, { "Text": "11.2.10 Neither Anima nor any of its Affiliates has entered into any agreement, whether written or oral, (excluding agreements described in Section 11.2 (Representations, Warranties, and Covenants, as applicable, of Anima) and excluding confidentiality and non-disclosure agreements entered into in the normal course) that (a) grants any Third Party any rights that are inconsistent with the rights granted to AbbVie hereunder or (b) expressly pertains to the Exploitation of the Licensed IP, in each case ((a) and (b)) that assigned, transferred, licensed, conveyed, or otherwise encumbered Anima's right, title, or interest in or to any of the foregoing;", "": "" }, { "Text": "11.2.11 No claim or litigation has been brought or asserted (and Anima has no Knowledge of any claim, whether or not brought or asserted) by any Person alleging that the Existing Patent Rights are invalid or unenforceable or the conception, development, reduction to practice, disclosing, copying, making, assigning, or licensing of the Existing Patent Rights or the Anima Background Know-How violates, infringes, or otherwise conflicts or interferes with, any intellectual property or proprietary right of any Person, nor, to Anima's Knowledge, do any facts or circumstances exist that would be reasonably expected to give rise to any such claims;", "": "" }, { "Text": "11.2.12 To Anima's Knowledge, no Person is infringing or threatening to infringe, or misappropriating or threatening to misappropriate, the Existing Patent Rights or the Anima Background Know-How;", "": "" }, { "Text": "11.2.13 To Anima's Knowledge, each of the Existing Patent Rights properly identifies each and every inventor of the claims thereof as determined in accordance with the laws of the jurisdiction in which such Existing Patent Right is issued or such application is pending;", "": "" }, { "Text": "11.2.14 There are no pending or, to Anima's Knowledge, alleged or threatened, (a) inter partes reviews, post-grant reviews, interferences, re-examinations, or oppositions involving the Existing Patent Rights that are in or before any patent authority (or other Governmental Authority performing similar functions) or (b) any inventorship challenges involving the Existing Patent Rights that are in or before any patent or other Governmental Authority;", "": "" }, { "Text": "11.2.15 Each Person who has or has had any rights in or to any Existing Patent Rights or any Anima Background Know-How has assigned and has executed an agreement assigning its entire right, title, and interest in and to such Existing Patent Rights or Anima Background Know-How to Anima or its Affiliate;", "": "" }, { "Text": "11.2.16 All works of authorship and all other materials subject to copyright protection included in Anima Background Know-How are original and were either created by employees of Anima or its Affiliates within the scope of their employment or are otherwise works made for hire, or all right, title, and interest in and to such materials have been legally and fully assigned and transferred to Anima or such Affiliate, and all rights in all inventions and discoveries made, developed, or conceived by an employee or independent contractor of Anima or any of its Affiliates during the course of their employment (or other retention) by Anima or such Affiliate, and included in Anima Background Know-How have been or will be assigned in writing to Anima or such Affiliate. All current and former employees and current and former independent contractors of Anima or its Affiliates have no right to receive additional compensation for any of the Anima Background Patents, Anima Background Know-How, Anima Improvements, or Licensed IP, including (as applicable) any right to receive compensation in connection with \"Service Inventions\" under Section 134 of the Israeli Patent Law-1967 or any other similar provision under any applicable Laws of any applicable jurisdiction;", "": "" }, { "Text": "11.2.17 Except as set forth in Schedule 11.2 (Anima Disclosure Schedule), to Anima's Knowledge, the inventions claimed by the Existing Patent Rights are not the subject of any licenses, options, or other rights of any Governmental Authority, within or outside the United States, due to such Governmental Authority's funding of research and development or otherwise (other than any right to receive payments or any law of general application that applies to personal property generally, e.g. takings laws). Without limiting the generality of the foregoing, the inventions claimed by the Existing Patent Rights (a) were not conceived, discovered, developed, or otherwise made in connection with any research activities funded, in whole or in part, by the federal government of the United States or Israel or any agency thereof (including the Israel Innovation Authority), (b) are not a \"subject invention\" as that term is described in 35 U.S.C. Section 201(e) and (c) are not otherwise subject to the provisions of the Patent and Trademark Law Amendments Act of 1980, as amended, codified at 35 U.S.C. §§ 200-212, as amended, as well as any regulations promulgated pursuant thereto, including in 37 C.F.R. part 401;", "": "" }, { "Text": "11.2.18 The confidential Anima Background Know-How has been kept confidential or has been disclosed to Third Parties only under terms of confidentiality. To the Knowledge of Anima and its Affiliates, no breach of such confidentiality has been committed by any Third Party;", "": "" }, { "Text": "11.2.19 None of the Anima Platform Technology, the UPenn Technology, or any other Patent Right or Know-How to which Anima or its Affiliates has rights but is not licensed to AbbVie hereunder is or will be, necessary to Exploit the data, information, or compounds to be provided in any License Option Exercise Data Package, including any compounds that are Developed by or on behalf of Anima or its Affiliates on or after the Effective Date in the conduct of activities under any Collaboration Plan;", "": "" }, { "Text": "11.2.20 Anima and its Affiliates and their respective subcontractors have not disclosed and will not disclose any UPenn Technology to AbbVie or to any of AbbVie's Affiliates or Sublicensees, in any form, including in any License Option Exercise Data Package (including any Hit Validation Data Package or Lead Optimization Data Package);", "": "" }, { "Text": "11.2.21 Neither Anima nor its Affiliates is a party to any agreement with the Israel Innovation Authority or any other Governmental Authority in Israel that refers or relates to the Anima Background Patents, Anima Background Know-How, Anima Improvements, Licensed IP, any Collaboration Target, or any activity contemplated hereunder;", "": "" }, { "Text": "11.2.22 To Anima's Knowledge, none of the Anima Background Patents and Anima Background Know-How is subject to any restriction that would require any Development, Manufacturing, or Commercialization activities under this Agreement to occur in a certain location or otherwise restrict the conduct of such activities with respect to location or the Person conducting such activities;", "": "" }, { "Text": "11.2.23 Anima and its Affiliates have conducted and will conduct, and their respective contractors and consultants have conducted and will conduct, all Development activities allocated to Anima hereunder in accordance with applicable Law in all material respects. Anima and its Affiliates have employed (and, with respect to such tests and studies that Anima will perform, will employ) Persons with appropriate education, knowledge, and experience to conduct and to oversee the conduct of such activities;", "": "" }, { "Text": "11.2.24 Anima and its Affiliates have not, and shall not during the Term of this Agreement, Process or provide to AbbVie or any of its Affiliates any Personal Data in connection with the activities under this Agreement;", "": "" }, { "Text": "11.2.25 In the last five (5) years, Anima has not received written notice of any alleged material violation from a Governmental Authority or other Third Party of any Data Security and Privacy Laws and has no Knowledge of facts that would give rise to such a violation. Anima is not under investigation by any Governmental Authority for a violation of Data Security and Privacy Laws;", "": "" }, { "Text": "11.2.26 The execution, delivery, and performance of this Agreement and the other agreements and instruments contemplated hereby, and the consummation of the transactions contemplated hereunder, complies with Data Security and Privacy Laws;", "": "" }, { "Text": "11.2.27 Except as set forth on Schedule 11.2 (Anima Disclosure Schedule), (a) patient information or patient-derived materials were not used in the development, invention, or generation of Anima Background Know-How or Anima Background Patents, (b) neither patient information nor patient-derived materials will be used in the conduct of activities under this Agreement by or on behalf of Anima, including in the Anima Compound Library or under the Collaboration Plan, and (c) Anima and its Affiliates and subcontractors have complied and will comply with all applicable Laws (including Data Security and Privacy Laws and laws regarding patient consent) related to the handling, storage, or use of patient information or patient-derived materials used in the conduct of activities under this Agreement. Neither Anima nor any of its Affiliates will enter into any agreement with a Third Party subcontractor pursuant to which Anima or its Affiliate or such subcontractor will use patient information or patient-derived materials in the conduct of activities under this Agreement, without AbbVie's prior written consent.", "": "" }, { "Text": "11.2.28 Neither Anima nor any of its Affiliates, nor any of its or their respective officers, employees, or agents has (a) committed an act, (b) made a statement, or (c) failed to act or make a statement that, in any case ((a), (b), and (c)), (i) would be or create an untrue statement of material fact or fraudulent statement to the FDA or any other Governmental Authority with respect to the Exploitation of the Royalty-Bearing Compounds or the Royalty-Bearing Products or (ii) could reasonably be expected to provide a basis for the FDA to invoke its policy respecting \"Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities,\" set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto or any analogous laws or policies in the Territory;", "": "" }, { "Text": "11.2.29 Anima shall cause all Persons who perform Development activities (including regulatory activities) for Anima under this Agreement or who conceive, discover, develop, or otherwise make any Know-How or Patent Rights by or on behalf of Anima or its Affiliates or its or their (sub)licensees under or in connection with this Agreement to be under an obligation to assign (or, if Anima is unable to cause such Person to agree to such assignment obligation despite using commercially reasonable efforts to negotiate such assignment obligation, provide an exclusive license under) their rights in any Know-How or Patent Rights resulting therefrom to Anima, except where applicable Law requires otherwise and except in the case of governmental, not-for-profit, and public institutions that have standard policies against such an assignment (in which case a suitable license, or right to obtain such a license, shall be obtained);", "": "" }, { "Text": "11.2.30 Anima will not grant any license relating to the Licensed IP, Anima Background Patents, Anima Background Know-How, or Anima Improvements that would conflict with the rights or licenses granted to AbbVie hereunder;", "": "" }, { "Text": "11.2.31 To Anima's Knowledge, no government authorization, consent, approval, license, exemption of, or filing or registration with any court or governmental department, commission, board, bureau, agency, or instrumentality, domestic or foreign, under any applicable Laws currently in effect, is or will be necessary for, or in connection with, the transaction contemplated by this Agreement or any other agreement or instrument executed in connection herewith, or for the performance by Anima of its obligations under this Agreement and such other agreements, except as may be required to obtain HSR Clearance; and", "": "" }, { "Text": "11.2.32 Anima and its Affiliates have not ever been and are not currently the subject of a proceeding that could lead to it or its Affiliates becoming a Debarred Entity, Excluded Entity, or Convicted Entity and Anima and its Affiliates will not use in any capacity, in connection with the obligations to be performed under this Agreement, any person who is a Debarred Individual, Excluded Individual or a Convicted Individual. Anima further covenants that if, during the Term, Anima or an Affiliate of Anima becomes a Debarred Entity, Excluded Entity, or Convicted Entity, or is listed on the FDA's Disqualified/Restricted List or if any of their respective employees or agents performing any of Anima's obligations hereunder becomes a Debarred Individual, an Excluded Individual, or a Convicted Individual, or is added to the FDA's Disqualified/Restricted List, then Anima shall immediately notify AbbVie and AbbVie shall have the option, at its sole discretion, to either: (a) prohibit such Person from performing work under this Agreement, (b) terminate all work being performed or to be performed by Anima pursuant to this Agreement, or (c) terminate this Agreement. This provision shall survive termination or expiration of this Agreement.", "": "" }, { "Text": "11.3 Compliance with Applicable Law. Each Party hereby covenants to the other Party that in performing its obligations or exercising its rights under this Agreement, such Party, its Affiliates, and its and their (sub)licensees/Sublicensees (other than Dispute Settlement Sublicensees), shall comply with all applicable Law.", "": "" }, { "Text": "11.4 Additional Covenants of Anima. During the Term, Anima shall not, and shall cause its Affiliates not to, (a) knowingly misappropriate or willfully infringe any valid and enforceable intellectual property rights of a Third Party in connection with the activities allocated to Anima under this Agreement, (b) enter into any agreement, whether written or oral, with respect to, or otherwise assign, transfer, license, convey, or otherwise encumber (including by granting any covenant not to sue) any Licensed IP, Anima Background Patents, Anima Background Know-How, Anima Improvements, Royalty-Bearing Compound, or Royalty-Bearing Product that is inconsistent with or otherwise diminishes the rights and licenses granted to AbbVie and its Affiliates hereunder, or (c) until the exercise of the applicable License Option, otherwise commit any act or permit the occurrence of any omission that, if such action had been committed or such omission had occurred prior to the Effective Date, would have caused any of the representations and warranties set forth in Section 11.2 (Representations, Warranties, and Covenants, as applicable, of Anima) to be untrue or materially misleading as of the Effective Date.", "": "" }, { "Text": "11.5 Anti-Bribery and Anti-Corruption Compliance. Each Party represents, warrants, and covenants to the other Party in connection with this Agreement that it and its Affiliates (a) have complied and will comply with all applicable Laws, rules, regulations, and industry codes governing bribery, money laundering, and other corrupt practices and behavior (including, as applicable, the U.S. Foreign Corrupt Practices Act, UK Bribery Act, Sections 290-297 of the Israeli Penal Law 1977 (Bribery Transactions) and the Israeli Prohibition on Money Laundering Law, 2000), and (b) will not, directly or indirectly, offer, give, pay, promise to pay, or authorize the payment of any bribes, kickbacks, influence payments, or other unlawful or improper inducements to any Person in whatever form (including gifts, travel, entertainment, contributions, or anything else of value). AbbVie may terminate this Agreement in its entirety, immediately on notice to Anima in the event that AbbVie receives any information which it in good faith determines, in its sole discretion, to be evidence of an actual, alleged, possible, or potential breach by Anima or its Affiliates of any representation, warranty, or covenant provided in this Section 11.5 (Anti-Bribery and Anti-Corruption Compliance). In the event of such termination, AbbVie shall have no liability to Anima for any charges, fees, reimbursements, or other compensation or claims under this Agreement, including for services previously performed.", "": "" }, { "Text": "11.6 Disclaimer. Except as otherwise expressly set forth in this Agreement, NEITHER PARTY MAKES ANY REPRESENTATION OR EXTENDS ANY WARRANTY OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY THAT ANY PATENT RIGHTS ARE VALID OR ENFORCEABLE, AND EXPRESSLY DISCLAIMS ALL IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND NONINFRINGEMENT.", "": "" }, { "Text": "ARTICLE 12 INDEMNIFICATION; INSURANCE", "": "" }, { "Text": "12.1 Indemnification by Abb", "": "" }, { "Text": "CONFIDENTIAL Execution Version", "": "" }, { "Text": "CONFIDENTIAL", "": "" }, { "Text": 1, "": "" }, { "Text": "31354/00100/FW/10099126.1", "": "" }, { "Text": "AMENDMENT NO. 3 TO MASTER COLLABORATION AGREEMENT", "": "" }, { "Text": "This Amendment No. 3 to the Master Collaboration Agreement (this \"Amendment\" or \"Amendment No. 3\") effective as of July 26, 2021 (the \"Third Amendment Date\"), is entered into by and among Calico Life Sciences LLC, a Delaware limited liability company with a place of business at 1170 Veterans Blvd., South San Francisco, CA 94080, and Calico LLC, a Delaware limited liability company with a place of business at 1170 Veterans Blvd., South San Francisco, CA 94080 (together with Calico Life Sciences LLC, \"Calico\"), AbbVie Biotechnology Limited, a Bermuda corporation with its registered office at Clarendon House, 2 Church Street, Hamilton HM 11 Bermuda (\"AbbVie\") and, solely for purposes of Section 17.13 of the Agreement, AbbVie Inc., a Delaware corporation with a place of business at 1 N. Waukegan Road, North Chicago, IL 60064.", "": "" }, { "Text": "WHEREAS, the Parties previously entered into that certain Master Collaboration Agreement dated as of September 3, 2014, amended by Amendment No. 1 dated March 13, 2017 and Amendment No. 2 dated June 20, 2018 (the \"Agreement\");", "": "" }, { "Text": "WHEREAS, the Parties desire to extend certain phases of the Collaboration and amend certain terms of the Agreement in connection therewith as set forth herein.", "": "" }, { "Text": "NOW THEREFORE, the Parties hereby agree as follows:", "": "" }, { "Text": "1. Amendments.", "": "" }, { "Text": "a. Section 1 of the Agreement is hereby amended by adding the following new Sections 1.165 - 1.169 immediately following the end of Section 1.164:", "": "" }, { "Text": "1.165 \"Funding Commitment Amount\" means an amount equal to the sum of the Initial Funding Amount, the Additional Funding Amount, and the Second Additional Funding Amount.", "": "" }, { "Text": "1.166 \"Second Additional Funding Amount\" means an amount equal to two times the Second Additional Payment Amount.", "": "" }, { "Text": "1.167 \"Second Additional Payment Amount\" means five hundred million dollars ($500,000,000), subject to adjustment pursuant to Section 4.5.4.", "": "" }, { "Text": "1.168 \"Second Calico Equity Contribution\" shall have the meaning set forth in Section 4.5.2.", "": "" }, { "Text": "1.169 \"Second Extension Funding Notice\" shall have the meaning set forth in Section 4.5.2.", "": "" }, { "Text": "b. Section 1.55 of the Agreement is hereby amended and restated in its entirety as follows:", "": "" }, { "Text": "1.55 \"Discovery Phase\" means the period of time commencing on the Effective Date and continuing until the sixteenth (16th) anniversary of the Effective Date.", "": "" }, { "Text": "c. Section 1.80 of the Agreement is hereby amended and restated in its entirety as follows:", "": "" }, { "Text": "1.80 \"Initial Phase\" means the period commencing on the Effective Date and ending on the earlier of (a) the eleventh (11th) anniversary thereof and (b) the date that the aggregate Collaboration Costs equal the Funding Commitment Amount.", "": "" }, { "Text": "d. The first sentence of Section 2.3.1 of the Agreement is hereby amended and restated in its entirety as follows:", "": "" }, { "Text": "Upon the earlier of (a) the date that is thirty (30) days after Calico determines that the aggregate Collaboration Costs will likely exceed the Funding Commitment Amount within the subsequent six (6)-month period of such determination and (b) the date that is six (6)-months prior to the eleventh (11th) anniversary of the Effective Date, Calico shall promptly provide AbbVie a written list of the then-current Research and Development Projects, including a high-level description of each such Research and Development Project and the compounds and molecules that are subject to each such Research and Development Project (the \"Projects List,\" and each Research and Development Project so listed, a \"Listed Project\" and each compound or molecule so listed, a \"Listed Product\").", "": "" }, { "Text": "e. Section 2.10.4 of the Agreement is hereby amended and restated in its entirety as follows:", "": "" }, { "Text": "2.10.4 During the Initial Phase, Calico shall ensure that (a) its efforts under the Excluded Projects will not materially detract from the effectiveness of, or interfere with, Calico's responsibilities under the Research and Development Projects or have a significant impact on Calico's ability to fund its obligations under this Agreement, (b) Calico does not exceed a total expense for such Excluded Projects of more than fifteen million dollars ($15,000,000) annually in each of the first three (3) years of the Initial Phase; more than twenty-five million dollars ($25,000,000) annually in each of the fourth and fifth years of the Initial Phase; more than one hundred and fifty million dollars ($150,000,000) in the aggregate during the sixth, seventh and eighth years of the Initial Phase; or more than one hundred and fifty million dollars ($150,000,000) in the aggregate during the ninth, tenth and eleventh years of the Initial Phase, (c) the total expenditure made by any collaborators of the Excluded Projects will not exceed Calico's expenditures for the Excluded Projects, and (d) Calico will not reallocate personnel from Research and Development Projects to the Excluded Projects; provided, that the foregoing will not restrict Arthur D. Levinson or any other officers or senior scientists of Calico from devoting a portion of their time to an Excluded Project to the extent such efforts with respect to all Excluded Projects in the aggregate do not materially detract from the effectiveness of, or interfere with, Calico's responsibilities under the Research and Development Projects.", "": "" }, { "Text": "f. Section 2.10 of the Agreement is hereby amended by adding the following new Section 2.10.6 immediately after the end of Section 2.10.5:", "": "" }, { "Text": "2.10.6 Calico represents and warrants to AbbVie that as of the Third Amendment Date Calico has not performed and is not performing any activities with respect to any Excluded Project.", "": "" }, { "Text": "g. Section 4.1 of the Agreement is hereby amended and restated in its entirety as follows:", "": "" }, { "Text": "4.1 Cost Sharing. During the Discovery Phase, all of the Collaboration Costs shall be shared equally by the Parties (fifty percent (50%) by each Party), subject to the provisions of this Section 4 and the Financial Appendix, including as concerns overspends pursuant to Section 6.2 of the Financial Appendix. AbbVie's share of Collaboration Costs shall initially be credited against the Upfront Payment Amount and, after the aggregate Collaboration Costs equal the Initial Funding Amount, the Additional Payment Amount and, after the aggregate Collaboration Costs equal the sum of the Initial Funding Amount and the Additional Funding Amount, the Second Additional Payment Amount. The Parties anticipate that the Collaboration Costs with respect to the Research Plan shall be approximately equal to the Funding Commitment Amount. If at any time after the Initial Phase AbbVie's share of Collaboration Costs exceeds the sum of the Upfront Payment Amount, Additional Payment Amount and the Second Additional Payment Amount, AbbVie shall then pay its share of Collaboration Costs to Calico on a calendar quarter basis in arrears in accordance with the Financial Appendix. Additional terms regarding determining the Collaboration Costs, and associated financial planning, accounting policies and procedures are set forth in the Financial Appendix. If the aggregate Collaboration Costs incurred during the Initial Phase are less than the Funding Commitment Amount, then the remaining amount of the Funding Commitment Amount shall be used to offset Collaboration Costs incurred during the remainder of the Discovery Phase and if the aggregate Collaboration Costs incurred during the entire Discovery Phase are less than the Funding Commitment Amount, then the remaining amount of the Funding Commitment Amount shall be used to offset Shared Costs related to the post-POC development, manufacture, commercialization or other exploitation of Licensed Products, unless another use for the remaining amount is agreed to in writing by the Parties.", "": "" }, { "Text": "h. Section 4.2.2(e) of the Agreement is hereby amended and restated in its entirety as follows:", "": "" }, { "Text": "(e) Subject to the last two sentences of Section 4.1, Calico shall use the Upfront Payment Amount, Additional Payment Amount and Second Additional Payment Amount solely to fund fifty percent (50%) of the Collaboration Costs and for no other purpose.", "": "" }, { "Text": "i. The first sentence of Section 4.4.2 of the Agreement is hereby amended and restated in its entirety as follows:", "": "" }, { "Text": "Calico shall have the right to raise up to fifty percent (50%) of the five hundred million dollar ($500,000,000) commitment set forth in Section 4.4.1 through the sale of equity to Third Party investors through one or more rounds; provided that (i) prior to September 3, 2024, with respect to the sale of equity to raise such fifty percent (50%) of incremental matching funding, Calico shall not sell any such equity to any Person (other than an individual) that is, or is a Subsidiary of, a biotechnology, biopharmaceutical, or pharmaceutical company, and (ii) Calico shall promptly notify AbbVie of any proposed sale of such equity to Third Party investors upon entering into any term sheet therefor.", "": "" }, { "Text": "j. Section 4.4 of the Agreement is hereby amended by adding the following new Section 4.4.5 immediately after the end of Section 4.4.4:", "": "" }, { "Text": "4.4.5 Calico represents and warrants to AbbVie that as of the Third Amendment Date Calico has not sold equity to any Third Party (other than to Alphabet Inc.) as set forth in Section 4.4.2.", "": "" }, { "Text": "k. Section 4 of the Agreement is hereby amended by adding the following new Section 4.5 immediately after the end of Section 4.4:", "": "" }, { "Text": "4.5 AbbVie Second Additional Payment.", "": "" }, { "Text": "4.5.1 Timing of AbbVie Payments", "": "" }, { "Text": "4.5.1.1 Within thirty (30) days following September 3, 2023, provided that Calico has delivered to AbbVie the Second Extension Funding Notice, AbbVie shall pay to Calico an amount equal to one-half of the Second Additional Payment Amount.", "": "" }, { "Text": "4.5.1.2 Within thirty (30) days following September 3, 2024, provided that Calico has delivered to AbbVie the Second Extension Funding Notice, AbbVie shall pay to Calico an amount equal to one-half of the Second Additional Payment Amount. If Calico reasonably anticipates that aggregate Collaboration Costs will exceed three billion dollars ($3,000,000,000) prior to September 3, 2024, Calico shall provide notice to AbbVie, and AbbVie shall instead make the payment contemplated by this Section 4.5.1.2 prior to the later of (i) thirty (30) days following September 3, 2023, and (ii) one-hundred eighty (180) days after the date AbbVie receives such notice.", "": "" }, { "Text": "4.5.1.3 AbbVie's payments pursuant to Sections 4.5.1.1 and 4.5.1.2 shall be AbbVie's share of the Second Additional Funding Amount.", "": "" }, { "Text": "4.5.2 The \"Second Extension Funding Notice\" shall consist of a certificate signed by an officer of Alphabet, in substantially the form attached hereto as Exhibit B, certifying that the Alphabet board of directors has approved a contribution to Calico of five hundred million dollars ($500,000,000) in addition to the previously approved contributions in the amount of the sum of the Upfront Payment Amount and the Additional Payment Amount (as described in such certificate), which additional funding amount may be reduced by up to two hundred and fifty million dollars ($250,000,000) for any amount raised by the sale of equity by Calico after the Third Amendment Date in accordance with Section 4.5.3 (such reduced portion to be raised by Calico, the \"Second Calico Equity Contribution\"); provided that, for any amount of the Second Calico Equity Contribution that Calico is unable to raise prior to the calendar quarter in which aggregate Collaboration Costs exceed three billion dollars ($3,000,000,000), Alphabet shall provide to Calico such unraised amount such that the sum of the amount contributed to Calico by Alphabet and the amount raised by Calico through the sale of equity after the Third Amendment Date equals five hundred million dollars ($500,000,000). In the event that the Alphabet board of directors does not approve Alphabet providing Calico additional funding as provided in this Section 4.5.2, Calico shall not provide the Second Extension Funding Notice, and Section 4.5.4 shall apply.", "": "" }, { "Text": "4.5.3 Calico shall have the right to raise up to fifty percent (50%) of the five hundred million dollar ($500,000,000) commitment set forth in Section 4.5.2 through the sale of equity to Third Party investors after the Third Amendment Date through one or more rounds; provided that (i) prior to September 3, 2024, with respect to the sale of equity to raise such fifty percent (50%) of incremental matching funding, Calico shall not sell any such equity to any Person (other than an individual) that is, or is a Subsidiary of, a biotechnology, biopharmaceutical, or pharmaceutical company, and (ii) Calico shall promptly notify AbbVie of any proposed sale of such equity to Third Party investors upon entering into any term sheet therefor. As a condition to the closing of any sale of any such equity, Calico shall issue to AbbVie or, at AbbVie's sole discretion, to an Affiliate of AbbVie, at no additional cost (other than any applicable tax withholdings, transfer or similar taxes or charges or pro rata costs resulting from or relating to the issuance of such equity consistent with the costs paid by the Third Party investors, which shall be for AbbVie's account), an amount of such equity equal to the aggregate amount of such equity sold to Third Party investors, and AbbVie shall be entitled to all of the same preferences, rights and other entitlements as such Third Party investors. Calico agrees to enter into such agreements with AbbVie and its Affiliates as are necessary to effect the purpose of this provision. Calico shall ensure that any such sale of equity does not limit or reduce Calico's right to access the intellectual property, services and other resources of Alphabet or its Affiliates and shall not enter into any agreement that would do so.", "": "" }, { "Text": "4.5.4 If AbbVie has not received the Second Extension Funding Notice by 11:59pm CST on September 3, 2022, then the Second Additional Payment Amount shall automatically be amended to be zero dollars ($0).", "": "" }, { "Text": "4.5.5 Calico shall use the Initial Funding Amount to fund the Collaboration Costs prior to using the Additional Funding Amount and shall use the Additional Funding Amount to fund Collaboration Costs prior to using the Second Additional Funding Amount. Calico shall use the Second Calico Equity Contribution solely to fund Collaboration Costs, subject to the terms of Section 4.1 regarding use of any surplus amounts after expiration of the Discovery Phase.", "": "" }, { "Text": "l. Sections 2.1(c) and 2.1(d) of the Financial Appendix of the Agreement are hereby amended and restated in their entirety as follows:", "": "" }, { "Text": "(c) if the sum of the Upfront Payment Amount, Additional Payment Amount, and Second Additional Payment Amount has not yet been credited against AbbVie's share of the Collaboration Costs, (i) the amount of AbbVie's share of the Collaboration Costs for the relevant calendar quarter to be credited against the Upfront Payment Amount, Additional Payment Amount, or the Second Additional Payment Amount, as applicable, and (ii) the remaining amount of the Upfront Payment Amount, Additional Payment Amount, and the Second Additional Payment, as applicable, that has not yet been credited against AbbVie's share of the Collaboration Costs; and", "": "" }, { "Text": "(d) if the sum of the Upfront Payment Amount, Additional Payment Amount, and Second Additional Payment Amount has been credited against AbbVie's share of the Collaboration Costs, (i) AbbVie's payment for its share of Collaboration Costs in accordance with Section 4.1 of the Agreement due for the relevant calendar quarter and (ii) calculations showing how such amount was determined;", "": "" }, { "Text": "m. The last sentence of Section 6.2 of the Financial Appendix of the Agreement is hereby amended and restated in its entirety as follows:", "": "" }, { "Text": "To the extent that any such overspend is not included in Collaboration Costs or Shared Costs, as applicable, as provided in the foregoing sentence, unless otherwise approved by the JSC, the Party that has exceeded the applicable Budget shall be solely responsible for the overspend and none of the Funding Commitment Amount shall be applied to any such overspend.", "": "" }, { "Text": "2. Miscellaneous. This Amendment shall be effective for all purposes as of the Second Amendment Date. Except as expressly modified herein, the Agreement shall continue to remain in full force and effect in accordance with its terms. This Amendment may be executed in counterparts, each of which shall be deemed to be an original and together shall be deemed to be one and the same document. In construing or interpreting this Amendment, (x) the word \"or\" shall not be construed as exclusive, (y) the word \"including\" shall not be limiting (irrespective of whether \"without limitation\" or other similar words are used to modify \"including\") and (z) the words \"shall\" and \"will\" have interchangeable meaning.", "": "" }, { "Text": "[Signatures on next page]", "": "" }, { "Text": "IN WITNESS WHEREOF, the parties have caused this Amendment to be executed by their respective duly authorized representatives effective as of the Second Amendment Date.", "": "" }, { "Text": "CALICO LIFE SCIENCES LLC", "": "" }, { "Text": "By: __________________________", "": "" }, { "Text": "Name: ________________________", "": "" }, { "Text": "Title: _________________________", "": "" }, { "Text": "CALICO LLC", "": "" }, { "Text": "By: __________________________", "": "" }, { "Text": "Name: ________________________", "": "" }, { "Text": "Title: _________________________", "": "" }, { "Text": "ABBVIE BIOTECHNOLOGY LIMITED", "": "" }, { "Text": "By: __________________________", "": "" }, { "Text": "Name: ________________________", "": "" }, { "Text": "Title: _________________________", "": "" }, { "Text": "Solely for purposes of Section 17.13 of the Agreement: ABBVIE INC.", "": "" }, { "Text": "By: __________________________", "": "" }, { "Text": "Name: ________________________", "": "" }, { "Text": "Title: _________________________", "": "" }, { "Text": "EXECUTION VERSION", "": "" }, { "Text": "SERVICES AGREEMENT", "": "" }, { "Text": "This Services Agreement (this \"Agreement\") is made and entered into effective as of September 3, 2014 (the \"Effective Date\"), by and among AbbVie Biotechnology Limited, a Bermuda corporation (\"AbbVie\"), solely for purposes of Section 11.14, AbbVie Inc., a Delaware corporation (\"Parent\"), and Calico Life Sciences LLC, a Delaware limited liability company and Calico LLC, a Delaware limited liability company (coilectively, \"Calico\"). AbbVie and Calico are each sometimes referred to herein individually as a \"Party\" and collectively as the \"Parties.", "": "" }, { "Text": "RECIFALS", "": "" }, { "Text": "WHEREAS, Calico, AbbVie and, solely for the purposes of Section 17.13 thereof, AbbVie, Inc. are parties to that certain Master Collaboration Agreement, dated as of September 3, 2014 (as may be amended from time to time, the \"Collaboration Agreement\"), pursuant to which, among other things, Calico and AbbVie will jointly fund the research, development and commercialization of Research Products and Licensed Products, all upon the terms and subject to the conditions set forth therein; and", "": "" }, { "Text": "WHEREAS, AbbVie desires to provide to Calico, and Calico desires to receive from AbbVie, the services described herein on the terms and conditions set forth herein.", "": "" }, { "Text": "NOW, THEREFORE, in consideration of the premises and the mutual promises and conditions set forth herein and in the Collaboration Agreement, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, do hereby agree as follows:", "": "" }, { "Text": "ARTICLE 1 DEFINITIONS", "": "" }, { "Text": "The following terms shall have the meanings ascribed to them in this Article 1, All other capitalized terms used but not defined in this Agreement shall have the respective meanings ascribed to them in the Collaboration Agreement.", "": "" }, { "Text": "1.1. \"AbbVie Indemnitee\" shall have the meaning set forth in Section 7.2.", "": "" }, { "Text": "12 \"Actual Quarterly R&D Expenditures\" means, with respect to a Calendar Quarter, the actual aggregate amount of Collaboration Costs for all Research and Development Projects during such Calendar Quarter.", "": "" }, { "Text": "13 \"Background Know-How\" means AbbVie Controlled Know-How that exists prior to the performance of the applicable Services by AbbVie, its Affiliates or subcontractors.", "": "" }, { "Text": "14 \"Background Patents\" means AbbVie Controlled Patents that exist prior to the performance of the applicable Services by AbbVic, its Affiliates or subcontractors.", "": "" }, { "Text": "1.5 \"Calendar Quarter\" means each successive period of three (3) calendar months commencing on January 1, April 1, July 1 and October 1, except that the first Calendar Quarter of the Term shall commence on the Effective Date and end on the day immediately prior to the first to occur of January 1, April 1, July", "": "" }, { "Text": "1.6 \"Calico Indemnitee\" shall have the meaning set forth in Section 7.1.", "": "" }, { "Text": "1.7 \"Claims\" shall have the meaning set forth in Section 7.1.", "": "" }, { "Text": "1.8 \"Estimated Quarterly R&D Expenditures\" means, with respect to a Calendar Quarter, the estimated aggregate amount of Collaboration Costs for all Research and Development Projects during such Calendar Quarter as set forth in the then- current Research Plan.", "": "" }, { "Text": "1.9 \"Identified Background IP\" means the Background Know-How or Background Patents, as applicable, for which AbbVie provides notification to Calico pursuant to Section 4.3.2.", "": "" }, { "Text": "1.10 \"Initial Services Forecast\" shali have the meaning set forth in Section 2.2.1.", "": "" }, { "Text": "1.11 \"Liability\" or \"Liabilities\" shall have the meaning set forth in Section 7.1.", "": "" }, { "Text": "1.12 \"Services\" shall have the meaning set forth in Section 2.1.", "": "" }, { "Text": "1.13 \"Services Costs\" means all of the actual costs incurred by AbbVie or its Affiliates to perform the Services under and in accordance with an applicable SOW determined based on the principles set forth m the Financial Appendix.", "": "" }, { "Text": "1.14 \"Services Forecast\" means the Initial Services Forecast or a Subsequent Services Forecast, as applicable.", "": "" }, { "Text": "1.15 \"SOW?\" shali have the meaning set forth in Section 2.2.4.", "": "" }, { "Text": "1.16 \"Subsequent Services Forecast\" shall have the meaning set forth in Section 2.2.1,", "": "" }, { "Text": "1.17 \"Term\" shall have the meaning set forth in Section 8.1.", "": "" }, { "Text": "ARTICLE 2 SERVICES", "": "" }, { "Text": "2.1 Services. Subject to the terms of this Agreement, AbbVie shall provide Calico services to support Calico in the Research and Development Projects under the Collaboration Agreement, including, as applicable, Medicinal Chemistry, Biology/Crystallography, Animal Pharmacology, DMPK, Phase I Unit, biologic capabilities, imaging capabilities, target engagement capabilities, pilot plants for small biologic molecules, technology platforms such as dual-variable domains and antibody-drug conjugates, and building engineering/construction/project management capabilities (he \"Services\") as and to the extent set forth in one or more mutually agreed upon SOWs executed and delivered by the Parties. The Services may include scientists, technicians and support staff, as well as facilities and equipment.", "": "" }, { "Text": "2.2 Forecasts and Statements of Work.", "": "" }, { "Text": "2.2.1 Attached hereto as Schedule 2.2.1 is the initial forecast of Services, on a Research and Development Project-by-Research and Development Project basis, that Calico desires to receive during the four (4) Calendar Quarters following the Effective Date (the \"Initial Services Forecast\"). No later than the fifteenth (15th) day of each Calendar Quarter following the Effective Date, Calico shall provide an updated Initial Services Forecast including the anticipated needs of Calico with respect to the Services to be provided under this Agreement, on a Research and Development Project-by-Research and Development Project basis, for the four (4) Calendar Quarters following the then current Calendar Quarter, not counting such Calendar Quarter (each, a \"Subsequent Services Forecast\").", "": "" }, { "Text": "2.2.2 During the first four (4) Calendar Quarters following the Effective Date (a) Calico shall use commercially reasonable efforts to appropriately forecast the Services needed, (b) AbbVie shall use commercially reasonable efforts to provide the requested Services, and (c} the Parties, in good faith, shall agree to amend the Initial Services Forecast and each Subsequent Services Forecast to reflect the necessary resources needed to provide the Services in the event the anticipated Service requirements change between preparation of the Subsequent Services Forecast.", "": "" }, { "Text": "2.2.3 Commencing with each Subsequent Services Forecast provided after the first four (4) Calendar Quarters following the Effective Date: (a) the scope of Services in the first Calendar Quarter of cach Subsequent Services Forecast may not materially change from the prior Subsequent Services Forecasts for such Calendar Quarter without AbbVie's prior written consent, provided that Calico may, without such consent, change the allocation of resources among the Research and Development Projects, (b) the second through fourth Calendar Quarters of each Subsequent Services Forecast will be for planning purposes only; provided, that Calico shall use commercially reasonable efforts to appropriately forecast the Services needed for such Calendar Quarters. Without AbbVie's prior consent, Calico will not provide a Subsequent Services Forecast in which the estimated Services Costs with respect to the Services for a Calendar Quarter would reasonably be expected to exceed fifty percent (50%) of the Estimated Quarterly R&D Expenditures with respect to such Calendar Quarter. If Calico requests that AbbVie provide Services with respect to a Research and Development Project that are not reflected in the then current Services Forecast, then the Parties shall use good faith efforts to negotiate an amendment to the then current Services Forecast to accommodate such request, subject to the limitation that AbbVie shall not be obligated to provide Services for which the estimated Services Costs for a Calendar Quarter would reasonably be expected to exceed fifty percent (50%) of the Estimated Quarterly R&D Expenditures for such Calendar Quarter.", "": "" }, { "Text": "2.2.4 AbbVie shall provide the Services, and Calico shall utilize and be obligated to pay for the Services, that is set forth in the first Calendar Quarter of each Subsequent Services Forecast. The Parties shall execute a separate statement of work (\"SOW\") for the Services for each Research and Development Project prior to AbbVie commencing the Services.", "": "" }, { "Text": "2.2.5 Each SOW shall be substantially in the form of Schedule 2.2.5 hereto and shall set forth: (a) the particular type and amount of Services to be provided by AbbVie under such SOW (including reports and other deliverables to be provided to Calico); (b) an anticipated timeline for the provision of such Services; and (c) additional provisions mutually agreed to by the Parties applicable to such Services to be provided pursuant to such SOW that are not otherwise set forth in this Agreement.", "": "" }, { "Text": "2.2.6 The Parties shall use good faith efforts to negotiate and execute the SOW and any necessary amendments to any SOW executed and delivered under this Agreement. If the Parties are unable to reach agreement on a SOW after twenty-five (25) days of negotiation (or less time for time sensitive matters), then the matter shall be escalated to the Parties' Senior Officers for resolution. If the Parties' Senior Officers are unable to agree on such matter within ten (10) days after the date of escalation, then upon a Party's request the Parties shall submit the matter to arbitration in accordance with Article 9.", "": "" }, { "Text": "2.2.7 To the extent any terms and conditions of this Agreement conflict with the terms and conditions of any SOW executed and delivered by the Parties, the terms and conditions of this Agreement shall control unless such SOW expressly and specifically states an intent to supersede this Agreement on a specific matter (and in such event, this Agreement shall be superseded only with respect to such SOW and only with respect to such matter). Unless the context otherwise requires, each reference to this \"Agreement,\" including each such reference in Article 11, shall include each SOW executed and delivered under this Agreement.", "": "" }, { "Text": "2.3. Performance by Affiliates or Third Parties.", "": "" }, { "Text": "2.3.1 The Parties shall consult regularly regarding the prioritization of the Services to be provided by AbbVie under this Agreement and the allocation of activities between AbbVie and its Third Party subcontractors to ensure that Calico is not resource constrained, and AbbVie shail consider in good faith Calico's comments in respect thereof.", "": "" }, { "Text": "2.3.2 Subject to the remainder of this Section 2.3.2, AbbVie shall, itself or through one or more of its Affiliates, provide Services whose estimated Services Costs account for at least the first twenty-five percent (25%) of the Estimated Quarterly R&D Expenditures for a Calendar Quarter. If (a) the estimated Services Costs with respect to Services set forth in SOWs executed and delivered by the Parties exceed twenty-five percent (25%) of the Estimated Quarterly R&D Expenditures for a Calendar Quarter, then AbbVie shall have the right to subcontract such excess utilization or (b) any Service set forth in a mutually agreed upon SOW executed and delivered by the Parties is of the type that AbbVie or its Affiliates would typically (sub)contract to a Third Party, then AbbVie shal! have the right to subcontract such Service; provided, that the (sub)contracted portion of the Services will not count towards the twenty-five percent (25%) threshold under clause (a).", "": "" }, { "Text": "2.3.3 If AbbVie desires to (sub)contract any of the Services in accordance with Section 2.3.2, AbbVie will (a) first consult with Calico and give Calico the option to contract for such Services directly with a Third Party, (b) ensure that the Third Party is subject to all applicable terms and conditions that AbbVie is subject to under this Agreement and the Collaboration Agreement (including ownership of intellectual property rights and confidentiality), and (c) remain responsible for Services to be performed by the Third Party. In no event shall AbbVie, either itself or through its Affiliates and any Third Parties, be obligated to perform in any Calendar Quarter Services whose estimated Services Costs account for more than fifty percent (50%) of the Estimated Quarterly R&D Expenditures for such Calendar Quarter.", "": "" }, { "Text": "2.3.4 If either (a) AbbVie (itself or through its Affiliates and any Third Parties} provides Services whose Services Costs account for more than fifty-five percent (55%) of the Actual Quarterly R&D Expenditures for a given Calendar Quarter or (b) AbbVie (itself or through its Affiliates) provides Services whose Services Costs account for more than twenty-seven-and-one-half percent (27.5%) of the Actual Quarterly R&D Expenditures for a given Calendar Quarter, then, in either case (a) or (b)), AbbVie shall have the option to proportionately reduce its obligation under Section 2.3.2 in future Calendar Quarters; provided, that (i) any credit may only be applied in the immediately succeeding three (3) Calendar Quarters, and (ii) such credit cannot exceed twenty-five (25)% of the Actual Quarterly R&D Expenditures in a single Calendar Quarter. For example, if in the first Calendar Quarter the Services Costs accounted for one hundred percent (100%) of the Actual Quarterly R&D Expenditures, then AbbVie would be entitled to reduce the Services by twenty-five percent (25%) in the second Calendar Quarter and by twenty percent (20%) in the third Calendar Quarter. Notwithstanding the foregoing, in the event that AbbVie does not notify Calico prior to commencement of the applicable Calendar Quarter that AbbVie will be exercising such credit for Services in excess of the percentage thresholds set forth in subsections (a) and (b) for such Calendar Quarter, then the ability of AbbVie to proportionately reduce its obligation pursuant to this Section 2.3.4 will not be applicable for such Calendar Quarter.", "": "" }, { "Text": "2.4 Performance Standard. AbbVie shall provide the Services in a manner such that they are considered a \"priority\" within the AbbVie organization. Without limiting Section 2.2.4, in the event of AbbVie's inability (or a delay in AbbVie's ability) to provide the Services under an SOW in accordance with the terms of this Agreement (including the applicable SOW), whether due to force majeure or otherwise, AbbVie shall promptly notify Calico of such event and the Parties will discuss in good faith how to proceed with respect to the provision of such Services.", "": "" }, { "Text": "2.5 Exclusions. Notwithstanding anything herein to the contrary, in no event shail AbbVie be obligated te provide any Services that would be (a) unlawful for AbbVie to provide or that would require AbbVie to violate any Applicable Law, or (b) inconsistent or conflict with a (i) Third Party contractual obligation or restriction, or (11) Third Party obligation or restriction that is in the process of being negotiated in good faith by AbbVie, in each case, where such obligation or restriction existed prior to Calico's request for performance of the applicable Services.", "": "" }, { "Text": "2.6 Material and Technology Transfer. In connection with the provision of the Services, Calico may from time to time transfer (or have a Third Party transfer) to AbbVie materials or other technology (the \"Materials\"). AbbVie shall use the Materials, and any information provided with the Materials, solely to perform the Services and in accordance with any Third Party restrictions that Calico provides with the Materials or the terms of any Third Party material transfer agreement covering the Materials shouid AbbVie execute such an agreement with a Third Party regarding the Materials (each a \"Third Party MTA\"). AbbVie shall not use the Materials, or any information provided with the Materials, for any other purpose. Except as set forth below with respect to AbbVie Affiliates and subcontractors, AbbVie shall not transfer the Materials, or any information provided with the Materials, to any Third Party without the prior express written consent of Calico. AbbVie shall limit transfer and disclosure of the Materials, and any information provided with the Materials, to its employees who are bound by written agreements with AbbVie to hold in confidence and not make use of the Materials for any purpose other than the Services. AbbVie shall notify Calico promptly upon discovery of any unauthorized use or disclosure of the Materials. Notwithstanding the foregoing, and subject to the terms of any applicable Third Party MTA, AbbVie shall be permitted to transfer Materials to its Affiliates and subcontractors solely in connection with the performance of the Services; provided, that such Affiliates and subcontractors shall be, mutatis mutandis, subject to the obligations set forth in this Section 2.6.", "": "" }, { "Text": "ARTICLE 3 COMPENSATION", "": "" }, { "Text": "3.1 Costs. Calico shall pay AbbVie the Services Costs for the Services provided pursuant to this Agreement.", "": "" }, { "Text": "3.2 AbbVie Invoicing. Within forty-five (45) days after the end of each Calendar Quarter, AbbVie shall deliver to Calico an invoice, with a true and accurate written report setting out in reasonable detail the aggregate amount of Services Costs for such Calendar Quarter.", "": "" }, { "Text": "3.3 Discussion and Timing of Payments. Within fifteen (15) days following the receipt of the invoice provided under Section 3.2, the Parties will discuss any questions that Calico may have thereon, and within forty-five (45) days following the receipt of such invoice, Calico shall make the payment owed to AbbVie for Services Costs for such Calendar Quarter.", "": "" }, { "Text": "3.4 Manner of Payment. All payments to be made under this Agreement shall be made in United States dollars and by bank wire transfer in immediately available funds to such bank account as may be designated in writing by AbbVie from time to time.", "": "" }, { "Text": "3.5 Taxes. In the event that Applicable Law requires Calico to withhold taxes with respect to any payment to be made by Calico to AbbVie pursuant to this Agreement, Calico shall withhold such taxes from the amount due and furnish AbbVie with proof of payment of such taxes within thirty (30) days of such payment, and except to the extent such withholding is required under Applicable Law, all payments from Calico to AbbVie under this Agreement shall be made without deduction or withholding of taxes. Any such tax required to be withheld will be an expense of and borne by AbbVie. Calico shall provide reasonable assistance to AbbVie in AbbVie's efforts to claim an exemption from withholding of such taxes, obtain a refund ef any such taxes withheld, or obtain a credit with respect to such taxes withheld. In order for AbbVie to secure an exemption from, or a reduction in, any withholding of taxes, Calico shali provide to AbbVie such forms as are reasonably required for each type of payment to be made pursuant to this Agreement for which an exemption from, or a reduction in, any withholding of taxes is sought, and in the event that a required form previously furnished by AbbVie expires, is incorrect, or is inapplicable to the type of payment to be made, due to a change in circumstances or otherwise, the Parties acknowledge that AbbVie may need to furnish new forms to Calico in order to secure an exemption from, or a reduction in, any withholding of taxes with respect to such payment. In the event that the governing tax authority retroactively determines that a payment made by Calico pursuant to this Agreement should have been subject to withholding (or to additional withholding) for taxes, and Calico remits such withholding tax to the tax authority, Calico will have the right to offset such amount (but not interest and penalties that may be imposed thereon) against future payment obligations of Calico under this Agreement; provided, that if no further payments or insufficient further payments are available against which offset may be pursued, Calico may pursue reimbursement by any remedy (at law or in equity) available to it.", "": "" }, { "Text": "3.6 Audit Rights.", "": "" }, { "Text": "3.6.1 Upon the written request of Calico, and not more than once in each calendar year, AbbVie shall permit an independent certified public accounting firm of nationally recognized standing reasonably acceptable to AbbVie, at Calico's expense, to have access during normal business hours to such of the financial records of AbbVie as may be reasonably necessary to verify the accuracy of the calculation of Services Costs for the twelve (12) Calendar Quarters immediately prior to the date of such request (other than records for which Calico has already conducted an audit under this Section).", "": "" }, { "Text": "3.6.2 If such accounting firm concludes that a discrepancy exists with respect to the calculation of Services Costs during the audited period, the Party benefiting from such discrepancy shall, as applicable, appropriately credit the discrepancy in the next accounting or pay to the other Party such additional amounts within thirty (30) days after the date Calico delivers to AbbVie such accounting firm's written report so concluding. The fees charged by such accounting firm shall be paid by Calico, unless a discrepancy larger than five percent (5%) was discovered in favor of AbbVie, in which case AbbVie shall pay such fees.", "": "" }, { "Text": "3.6.3 Calico shall cause its accounting firm to retain all financial information subject to review under this Section in strict confidence; provided, that AbbVie shall have the right to require that such accounting firm, prior to conducting such audit, enter into an appropriate non-disclosure agreement with AbbVie regarding such financial information. The accounting firm shall disclose to Calico only whether the calculation of Services Costs are correct or not and the amount of any discrepancy. No other information shall be shared.", "": "" }, { "Text": "ARTICLE 4 OWNERSHIP OF ASSETS AND INTELLECTUAL PROPERTY", "": "" }, { "Text": "4.1 Ownership.", "": "" }, { "Text": "4.1.1 In accordance with Section 9.1.2 of the Collaboration Agreement, and except as provided in Section 4.1.2, as between the Parties, the Parties shall each own an equal, undivided interest in any and all (a) Know-How, inventions and other intellectual property that are conceived, discovered, developed or otherwise made by AbbVie or its Affiliates or its or their licensees or sublicensees or (sub)contractors under this Agreement (whether solely or jointly with Calico or its Affiliates or its or their licensees or sublicensees), and {b} Patents and other inteliectual property rights with respect to the Know-How, inventions and other intellectual property described in clause (a) (collectively, the \"Developed IP\"). Except as provided in the foregoing sentence, this Agreement and the performance of the Services hereunder shall not affect the ownership of any assets or intellectual property rights of the Parties or their respective Affiliates.", "": "" }, { "Text": "4.1.2 In some instances, Calico may be obligated by a licensor or collaborator (\"Counterparty\") to grant ownership to (or have joint ownership with) such Counterparty, or to flow-through other obligations or restrictions with respect to any Know-How, inventions or other intellectual property that is developed through the use of such Counterparty's material or technology ('Counterparty Assets\"). In such case if Calico desires to utilize such Counterparty Assets in connection with the Services, then Calico shall promptly provide AbbVie notice of any relevant contractual requirements, including the nature and scope of intellectual property to be developed pursuant to the arrangement with the Counterparty, and provide any additional information related to such intellectual property, subject to any contractual confidentiality obligations, that AbbVie may reasonably request. Upon receipt of all relevant information from Calico, AbbVie shall, in its sole discretion, determine whether to consent to the assignment of AbbVie's interest in any Developed IP resulting from the use of such Counterparty Assets to Calico or to otherwise be subject to such obligations and restrictions; provided, that AbbVie's consent hereunder shall not be unreasonably withheld or delayed. Notwithstanding the foregoing, Calico shall use commercialiy reasonable efforts to limit any grants of ownership rights to the Counterparty or other flow-through obligations or restrictions with respect to such intellectual property developed using the Counterparty Assets.", "": "" }, { "Text": "4.2 Limited License. Calico, on behalf of itself and its Affiliates, hereby grants to AbbVie and its Affiliates a non-exclusive, royalty-free, non-transferable (except as provided in Section 10.1) (a) license, with the right to grant further licenses and sublicenses, to all Patents, Know-How and other intellectual property rights Controlled by Calico or any of its Affiliates that are necessary or useful for providing the Services and (b) right of reference and use, with the right to grant further rights of reference and use, under any Regulatory Documentation Controlled by Calico or any of its Affiliates that are necessary or useful for providing the Services, in each case ((a) and (b)), for the sole purpose of providing the Services.", "": "" }, { "Text": "4.3 Background Know-How License; Identified Background IP.", "": "" }, { "Text": "4.3.1 If AbbVie does not provide prior notice to Calico of the use or incorporation of Background Know-How in connection with the performance of Services for a Research and Development Project, then AbbVie and its Affiliates, as applicable, hereby grants to Calico a perpetual, non-exclusive, royalty-free, worldwide, fully paid-up license (with rights to sublicense through multiple tiers of sublicensees) to practice and use such Background Know-How solely in connection with the development and commercialization of any products resulting from such Research and Development Project.", "": "" }, { "Text": "4.3.2 If AbbVie provides prior notice to Calico of the potential use or incorporation of Identified Background IP in connection with the performance of Services for a Research and Development Project, then (a) the Parties shall discuss in good faith the use of such Identified Background IP for a Research and Development Project, and (b) if AbbVie and Calico are unabie to obtain written agreement regarding the use of such Identified Background IP, then AbbVie shall not use or incorporate such Identified Background IP in the performance of such Services and Calico shall have no rights in or to such Identified Background IP,", "": "" }, { "Text": "4.4 Joint Research Agreement. The Parties agree that this Agreement shall constitute a joint research agreement under 35 U.S.C. 102(c).", "": "" }, { "Text": "4.5 Use of Developed IP. Notwithstanding Section 9.1.2 of the Collaboration Agreement, with respect to any Developed IP that results from a Research and Development Project, (a) AbbVie shall not use, practice or disclose the Developed IP resulting from such Research and Development Project that directly or indirectly enables the research, development or commercialization of a product or service that would reasonably be expected to be competitive with a product resulting from a Research and Development Project (i) during the Initial Phase, or (ii) after AbbVie (A) fails to exercise an Option with respect to a Research and Development Project (including any AbbVie Unexercised Projects), (B) exercises its Option but subsequently provides an Opt-Out Notice with respect to the Research and Development Project, or (C) exercises an AbbVie Exclusion Option; and (b) Calico shall not use, practice or disclose the Developed IP resulting from such Research and Development Project that directly or indirectly enables the research, development or commercialization of a product or service that would be reasonably expected to be competitive with a product resulting from a Research and Development Project after Abb Vie exercises an Option and for so long as AbbVie has not provided an Opt-Out Notice with respect to the Research and Development Project.", "": "" }, { "Text": "ARTICLE 5 CONFIDENTIALITY", "": "" }, { "Text": "All proprietary or confidential data, information or Know-How, including Background IP, of whatever kind and in whatever form or medium, that is disclosed by or on behalf of a Party to the other Party in connection with this Agreement shall be considered Confidential Information under the Collaboration Apreement and subject to the terms of Section 13 of the Collaboration Agreement. For clarity, information that AbbVie or its Affiliates or (sub)contractors obtain from a Third Party at the direction of Calico (including from a Calico in- licensor or consultant) and information that Calico might provide to AbbVie or its Affiliates or (sub)contractors in advance of utilizing the Services for a particular Research and Development Project (including when no Services are ultimately used for the given Research and Development Project or the Research and Development Project becomes an Excluded Project) shall in each case be considered Calico's Confidential Information under the Collaboration Agreement and subject to the terms of Section 13 of the Collaboration Agreement.", "": "" }, { "Text": "ARTICLE 6 REPRESENTATIONS AND WARRANTIES; DISCLAIMER", "": "" }, { "Text": "6.1 Mutual Representations and Warranties, Each Party hereby represents and warrants fo the other Party as of the Effective Date that: (a) it is duly organized, validly existing, and in good standing under Applicable Law; (b) it has obtained all necessary consents, approvals and authorizations of all governmental authorities and other Persons required to be obtained by if in connection with this Agreement; (c) the execution, delivery and performance of this Agreement have been duly authorized by all necessary corporate or similar action on its part; and (d) it has the right to grant the applicable rights and licenses provided for under this Agreement.", "": "" }, { "Text": "6.2 Disclaimers. EXCEPT AS OTHERWISE EXPRESSLY STATED IN THIS AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATION OR WARRANTY OF ANY KIND WITH RESPECT TO SERVICES TO BE PROVIDED HEREUNDER, AND EACH PARTY HEREBY EXPRESSLY DISCLAIMS ANY AND ALL IMPLIED WARRANTIES = OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE WITH RESPECT THERETO.", "": "" }, { "Text": "ARTICLE 7 INDEMNIFICATION", "": "" }, { "Text": "7.1 Indemnification by AbbVie. AbbVie will indemnify, defend, and hold each of Calico, its Affiliates, Google and its and their respective directors, officers, employees and agents, together with the successors and assigns of any of the foregoing (each, a \"Calico Indemnitee\"), harmless from and against any and all liabilities, damages, settlements, penalties, fines, costs or expenses (including reasonable attorneys' fees and other expenses of litigation) (individually, a \"Liability\" and collectively, \"Liabilities\") arising, directly or indirectly, out of or in connection with any and all Third Party claims, suits, actions, demands or judgments (collectively, \"Claims\") to the extent resulting from the (a) negligence or willful misconduct of any AbbVie Indemnitee or (b) breach by AbbVie of any of its representations, warranties or covenants under this Agreement.", "": "" }, { "Text": "7.2 Indemnification by Calico. Calico will indemnify, defend, and hold each of AbbVie, its Affiliates, and its and their respective directors, officers, employees and agents, together with the successors and assigns of any of the foregoing (each, an \"AbbVie Indemnitee\"), harmless from and against any and all Liabilities arising, directly or indirectly, out of or in connection with any and all Claims to the extent resulting from the (a) negligence or willful misconduct of any Calico Indemnitee, (b) breach by Calico of any of its representations, warranties or covenants under this Agreement, (c) deliverables, including materials, information and technology, provided by Calico to AbbVie that are necessary for the performance of Services, and (d) the performance of Services where Calico specifies the nature and scope of such Services, without meaningful consultation or input from AbbVie, except in each case ((a) - (d)), to the extent such Liabilities result from the (x) negligence or willful misconduct of any AbbVie Indemnitee or (y) breach by AbbVie of any of its representations, warranties or covenants under this Agreement.", "": "" }, { "Text": "7.3 Procedure. Ali indemnification claims of any Calico Indemnitee or AbbVie Indemnitee shall be made in accordance with the procedures of Section 12.4 of the Collaboration Agreement.", "": "" }, { "Text": "7.4 Limitation of Damages. EXCEPT IN THE EVENT OF A PARTY'S BREACH OF ITS OBLIGATIONS UNDER ARTICLE 5, NEITHER PARTY WILL BE LIABLE TO THE OTHER FOR ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL, EXEMPLARY, PUNITIVE OR OTHER SIMILAR DAMAGES (INCLUDING ANY CLAIMS FOR LOST PROFITS OR REVENUES) ARISING FROM OR RELATING TO THIS AGREEMENT OR PERFORMANCE UNDER, AND REGARDLESS OF ANY NOTICE OF SUCH DAMAGES; PROVIDED, THAT THE FOREGOING IS NOT INTENDED TO LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF EITHER PARTY WITH RESPECT TO ANY THIRD PARTY CLAIMS. NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS AGREEMENT, EXCEPT FOR THE PERFORMANCE OF SERVICES WHERE ABBVIE HAS PROVIDED MEANINGFUL CONSULTATION OR INPUT TO CALICO REGARDING THE NATURE AND SCOPE OF SUCH SERVICES, AND WITHOUT LIMITING OR REDUCING ABBVIE'S OBLIGATION TO PROVIDE THE SERVICES UNDER THIS AGREEMENT AND THE COLLABORATION AGREEMENT, OR ABBVIE'S OBLIGATIONS UNDER SECTIONS 4 OR 7, IN NO EVENT SHALL ABBVIE'S LIABILITY UNDER THIS AGREEMENT IN ANY CALENDAR YEAR EXCEED THE AMOUNT OF THE SERVICES COSTS PAYABLE BY CALICO TO ABBVIE HEREUNDER WITH RESPECT TO SUCH CALENDAR YEAR.", "": "" }, { "Text": "ARTICLE 8 TERM AND TERMINATION", "": "" }, { "Text": "8.1 Term. This Agreement shall commence on the Effective Date and continue until the earliest of (such period, the \"Term\"): (a) the end of the Initial Phase (and Discovery Phase, as mutually agreed); (b) termination of this Agreement pursuant to Section 8.2; and (c)the expiration or termination of the Collaboration Agreement.", "": "" }, { "Text": "8.2 Termination by Mutual Agreement. This Agreement may be terminated at any time by mutual written agreement of the Parties. Neither Party shall have the right to unilaterally terminate this Agreement, in part or in its entirety, for any reason. It is the Parties' intent to provide relief or compensation to either Party hereunder in the event of the other Party's material breach of any material provision of this Agreement, not through the termination of this Agreement but through remedies in law or equity, such as injunctive relief, specific performance and monetary damages.", "": "" }, { "Text": "8.3 Effects of Termination. The expiration or earlier termination of this Agreement, for any reason, shall not affect any rights or obligations that have already accrued as of the date of such expiration or termination, nor preclude either Party from pursuing any rights and remedies it may have under this Agreement or at law or in equity which accrued or are based upon any event occurring before expiration or termination.", "": "" }, { "Text": "8.4 Survival. Articles 5, 7, 9, and 11 and Sections 4.1, 4.3, 4.4, 4.5 and this Section 8.4 and the definitions for any defined terms contained within this Agreement or incorporated by reference to the Collaboration Agreement shall survive expiration or termination of this Agreement.", "": "" }, { "Text": "ARTICLE 9 ARBITRATION", "": "" }, { "Text": "Subject to Section 11.11, any dispute, controversy or claim initiated by either Party arising out of, resulting from or relating to this Agreement, or the performance by either Party of its obligations under this Agreement, whether before or after termination of this Agreement, shall be finally resolved by binding arbitration in accordance with this Article 9. The decision of the arbitrator shall be final and binding on the Parties. The arbitration will be conducted in San Francisco, California in accordance with the terms set forth in this Article and such other terms as are set forth in the commercial arbitration rules of the American Arbitration Association (AAA). The arbitration shall be conducted by one (1) arbitrator mutually agreed upon by the Parties. If the Parties are not able to mutually agree on an arbitrator within twenty (20) days after the date that a Party requests arbitration as provided in this Article, then the arbitrator will be selected as provided in the AAA rules within ten (10) days thereafter. The arbitrator will have expertise and experience with arbitration in the nature described in this Article. Within fifteen (15) business days after appointment of the arbitrator each Party shall deliver to the arbitrator and the other Party its proposal regarding the dispute. The arbitrator shall give each Party the opportunity to explain to the arbitrator why its proposal is more appropriate than the other Party's proposal, which may include conducting an oral argument or an evidentiary hearing if the arbitrator determines that it would assist the arbitrator's decision of which proposal to select. The arbitrator shall, within fifteen (15) business days after receipt of the two proposals and having heard each Party's rationale for its proposal, select one of the proposals from the two submitted. The proposal selected by the arbitrator shall be binding on the Parties as if mutually agreed by the Parties. THE ARBITRATOR MAY NOT MODIFY OR ALTER THE TERMS IN EITHER PARTY'S PROPOSAL. The cost of the arbitration shall be borne by the Party whose proposal was not accepted by the arbitrator. Notwithstanding the foregoing, either Party shall have the right, without waiving any right or remedy available to such Party under this Agreement or otherwise, to seek and obtain from any court of competent jurisdiction any interim or provisional relief that is necessary or desirable to protect the rights or property of such Party, pending the selection of the arbitrators hereunder or pending the arbitrators' determination of any dispute, controversy or claim hereunder.", "": "" }, { "Text": "ARTICLE 10 ASSIGNMENT", "": "" }, { "Text": "10.1 Assignment. Neither Party is permitted to assign this Agreement (whether by operation of law or otherwise) without the express prior written consent of the other Party; provided, that (a) a Party shall have the right, without such consent, to assign this Agreement, in whole or in part, to any of its Affiliates; provided, further, that a Party shall provide written notice to the other Party within thirty (30) days after such assignment or delegation to any of its Affiliates; and (b) either Party may assign this Agreement, without such consent, in connection with a Change of Control of such Party, so long as the entity to which this Agreement is assigned expressly agrees in writing to assume and be bound by all obligations of the assigning Party under (i) this Agreement and (ii) the Collaboration Agreement. Any permitted successor of a Party or any permitted assignee of all of a Party's rights under this Agreement that has also assumed all of such Party's obligations hereunder in writing shall, upon any such succession or assignment and assumption, be deemed to be a party to this Agreement as though named herein in substitution for the assigning Party, whereupon the assigning Party shall cease to be a party fo this Agreement and shall cease to have any rights or obligations under this Agreement.", "": "" }, { "Text": "10.2 Miscellaneous. Any purported assignment without a required consent is null and void. No assignment will relieve any Party of responsibility for the performance of any obligation that accrued before the effective date of assignment. This Agreement is binding upon the permitted successors and assigns of the Parties.", "": "" }, { "Text": "ARTICLE 11 MISCELLANEOUS", "": "" }, { "Text": "11.1 Governing Law. This Agreement is governed by and is construed in accordance with the laws of the State of California, without reference to principles of conflicts of laws and the patent laws of the applicable jurisdiction, except for inventorship which shall be determined under the patent law of the United States of America.", "": "" }, { "Text": "11.2 Independent Contractors. Nothing in this Agreement is intended or will be deemed to constitute a partnership, agency, distributorship, employer-employee relationship or joint venture relationship between the Parties, including for all tax purposes. No Party is permitted or shall have any authority to bind or make any commitments for or on behalf of the other Party, except to the extent expressly provided in this Agreement. All persons employed by a Party shall be employees of such Party and not of the other Party and, except as otherwise expressly set forth herein, all costs and obligations incurred by reason of any such empioyment shall be for the account and expense of such first Party.", "": "" }, { "Text": "11.3 Performance by Affiliates. Each Party is responsible for its Affiliates' performance of any activities under this Agreement, and will cause its Affiliates to comply with the provisions of this Agreement in connection with such performance.", "": "" }, { "Text": "11.4 No Strict Construction; Headings; Interpretation. This Agreement has been prepared jointly and will not be strictly construed against either Party. Ambiguities, if any, in this Agreement will not be construed against any Party, irrespective of which Party may be deemed to have authored the ambiguous provision. The headings of each Section and Article in this Agreement have been inserted for convenience of reference only and are not intended to limit or expand the meaning of the language contained in the Section or Article. In construing or interpreting this Agreement, unless the context of this Agreement requires otherwise, (a) the word \"or\" shall not be construed as exclusive, and the word \"including\" shall not be limiting, (b) the use of the singular or plural form shall include the other form, (c) the use of the masculine, feminine, or neuter gender shall include the other genders, (d) words such as \"in this Agreement\", \"hereof\", and \"hereunder\" refer to this Agreement as a whole and not merely to the particular provision in which such words appear, and (e) the terms \"shall\" and \"will\" have interchangeable meaning.", "": "" }, { "Text": "11.5 Further Actions. Each Party will execute, acknowledge and deliver such further instruments, and to do all such other acts, as may be necessary or appropriate in order to carry out the purposes and intent of this Agreement.", "": "" }, { "Text": "11.6 Notices and Deliveries. Except as otherwise expressly provided in the Agreement, any notice required under this Agreement will be in writing and will specifically refer to this Agreement. Notices will be sent via one of the following means and will be effective: (a) on the date of delivery, if delivered in person; or (b) on the date of receipt, if sent by internationally recognized private express courier with signature required upon delivery. Notices will be sent to the other Party at the addresses set forth below. Either Party may change its addresses for purposes of this Section 11.6 by sending written notice to the other Party.", "": "" }, { "Text": "If to AbbVie: AbbVie Inc. 1 North Waukegan Road North Chicago, Illinois 60064 U.S. Attention: Executive Vice President, Chief Scientific Officer Facsimile: (847) 938-6336 With a copy (which shall not constitute notice) to: AbbVie Inc. 1 North Waukegan Road North Chicago, Illinois 60064 U.S. Attention: Executive Vice President, Business Development, External Affairs and General Counsel Facsimile: (847) 935-3294", "": "" }, { "Text": "If to Calico: Calico 1170 Veterans Blvd. South San Francisco, CA 94080 Attention: President of Research and Development Facsimile: (650) 583-1003 With a copy (which shail not constitute notice) to: Fenwick & West LLP Silicon Valley Center 801 California Street Mountain View, CA 94041 Attention: Gordon K. Davidson Facsimile: (650) 938-5200", "": "" }, { "Text": "11.7 Force Majeure. Neither Party will lose any rights hereunder or be liable to the other Party for damages or losses (except for payment obligations) on account of failure of performance by the nonperforming Party if the failure is occasioned by war, strike, fire, Act of God, earthquake, flood, lockout, embargo, governmental acts or orders or restrictions, failure of suppliers, prevention from or hindrance in obtaining energy or other utilities, or any other reason where failure to perform is beyond the reasonable control and not caused by the negligence, intentional conduct, or misconduct of the nonperforming Party and the nonperforming Party has exerted all reasonable efforts fo avoid or remedy such force majeure; but, in no event will a Party be required to settle any labor dispute or disturbance.", "": "" }, { "Text": "11.8 Severability; Waiver. If any one or more of the provisions of this Agreement should for any reason be held by any court or authority having jurisdiction over this Agreement or either of the Parties to be invalid, iilegal or unenforceable, such provision or provisions will be validly reformed to as nearly as possible approximate the intent of the Parties and, if it cannot be reformed, will be divisible and deleted. Any delay in enforcing a Party's rights under this Agreement or any waiver as to a particular default or other matter will not constitute a waiver of such Party's rights to the future enforcement of its rights under this Agreement, except with respect to an express written and signed waiver relating to a particular matter for a particular period of time.", "": "" }, { "Text": "11.9 Entire Agreement; Modification. This Agreement, together with the Collaboration Agreement, constitutes the entire understanding and agreement of the Parties with respect to the subject matter hereof and supersedes any and all pricr negotiations, correspondence, understandings and agreements, whether verbal or written, between the Parties. No modification or amendment of any provision of this Agreement is valid or effective unless made in writing and signed by a duly authorized officer of each of the Parties.", "": "" }, { "Text": "11.10 Counterparts, This Agreement may be executed in two (2) or more counterparts, each of which will be deemed an original, but all of which together will constitute one and the same instrument. This Agreement may be executed by facsimile, PDF format via email or other electronically transmitted signatures and such signatures shall be deemed to bind each Party as if they were original signatures.", "": "" }, { "Text": "11.11 Equitable Relief. Each Party acknowledges and agrees that the restrictions set forth in Article 4 and Article 5 are reasonable and necessary to protect the legitimate interests of the other Party and that such other Party would not have entered into this Agreement in the absence of such restrictions and that any breach or threatened breach of any provision of such Articles may result in irreparable injury to such other Party for which there will be no adequate remedy at law. Notwithstanding Article 9, in the event of a breach or threatened breach of any provision of such Articles, the non-breaching Party shall be authorized and entitled to seek from any court of competent jurisdiction injunctive relief, whether preliminary or permanent, specific performance and an equitable accounting of ail earnings, profits and other benefits arising from such breach, which rights shall be cumulative and in addition to any other rights or remedies to which such non- breaching Party may be entitled in law or equity. Both Parties agree to waive any requirement that the other (a) post a bond or other security as a condition for obtaining any such relief and (b) show irreparable harm, balancing of harms, consideration of the public interest or inadequacy of monetary damages as a remedy, Nothing in this Section 11.11 is intended or should be construed, to limit either Party's right to equitable relief or any other remedy for a breach of any other provision of this Agreement under the last sentence of Article 9.", "": "" }, { "Text": "11.12 No Benefit to Third Parties. The covenants and agreements set forth in this Agreement are for the sole benefit of the Parties hereto and their successors and permitted assigns and they shall not be construed as conferring any rights on any other Person.", "": "" }, { "Text": "11.13 Priority of this Agreement. In the event of any inconsistency between this Agreement and the Collaboration Agreement, the terms of the Collaboration Agreement shall prevail. In the event of any inconsistency between a SOW and the Collaboration Agreement, the terms of the Collaboration Agreement shal! prevail unless such SOW expressly and specifically states an intent to supersede the Collaboration Agreement on a specific matter (and in such event, the Collaboration Agreement shall be superseded only with respect to such SOW and only with respect to such matter),", "": "" }, { "Text": "11.14 AbbVie Parent Guaranty. Parent unconditionally and irrevocably guarantees the due and punctual performance by AbbVie of each obligation, duty, warranty and undertaking contained in this Agreement on the part of AbbVie (the \"Obligations\"). Upon any failure of AbbVie to satisfy any Obligation, Parent shall, promptly upon written notice by Calico alleging any such failure or default thereof, perform (or cause the performance of) such Obligations in AbbVie's stead. Following any such failure of AbbVie to satisfy any such Obligation, Calico may enforce Parent's obligations under this Section 11.14 without first (a) suing AbbVie, (b) joining AbbVie in a suit against Parent or (c) enforcing any other rights and remedies against AbbVie. However, each of the rights, defenses, limitations, conditions and qualifications on and with respect to the obligations of AbbVie hereunder (other than any such defense based upon or relating to the bankruptcy or insolvency of AbbVie) shall apply with equal force and effect to the obligations of Parent in respect of this guaranty. In addition, any uses of \"AbbVie\" that should by their application include Parent, shall be deemed to include Parent. By way of example, and without limitation, obligations on AbbVie to perform the Services would include the use of employees and resources of Parent.", "": "" }, { "Text": "[Signature page follows]", "": "" }, { "Text": "IN WITNESS WHEREOF, the Parties have executed this Agreement as of the Effective Date.", "": "" }, { "Text": "CALICO LIFE SCIENCES LLC", "": "" }, { "Text": "By: Dhaad Ae", "": "" }, { "Text": "Name: AyHawre Dp. Lewes MESy)", "": "" }, { "Text": "Title: CEO", "": "" }, { "Text": "Date: Seplember 3, Zale", "": "" }, { "Text": "CALI LLC", "": "" }, { "Text": "by in kk", "": "" }, { "Text": "Name: A VAC D:", "": "" }, { "Text": "Title: (ED", "": "" }, { "Text": "Date: Seplember 5, ZH", "": "" }, { "Text": "ABBVIE BIOTECHNOLOGY LIMITED", "": "" }, { "Text": "By: —S ; LALA WeanbeO", "": "" }, { "Text": "Name: = EPKEM Maye dey yol", "": "" }, { "Text": "rite UC Ma rl salt act cov bo preeey", "": "" }, { "Text": "Date: & plenber § 20 -", "": "" }, { "Text": "Solely for purposes of Section 11.14:", "": "" }, { "Text": "ABBYIE INC.", "": "" }, { "Text": "By: The —_—", "": "" }, { "Text": "Name: Michael Severina", "": "" }, { "Text": "Title: E UP, AndChiet S ouenficl pe, Ked", "": "" }, { "Text": "Date: _Soptleenber 3 2014", "": "" }, { "Text": "[Signature page to Services Agreement]", "": "" }, { "Text": "Schedule 2.2.1", "": "" }, { "Text": "Initial Forecast of Services", "": "" }, { "Text": "See Attached", "": "" }, { "Text": "Schedule 2.2.5", "": "" }, { "Text": "Form of Statement of Work", "": "" }, { "Text": "Statement of Work No.: [nsert SOW#", "": "" }, { "Text": "This SOW is issued under the Services Agreement, dated as of (the \"Agreement\") by and between AbbVie Biotechnology Limited, a Bermuda corporation (\"AbbVie\"), and Calico Life Sciences LLC, a Delaware limited liability company and Calico LLC, a Delaware limited liability company (collectively, \"Calico\"). This SOW includes the terms and conditions of the Agreement, which are hereby incorporated by this reference as though the same was set forth in their entirety. All capitalized terms which are not defined herein shall have the same meanings as set forth in the Agreement.", "": "" }, { "Text": "1. Contacts. [Insert special contacts for this SOW, if applicable]", "": "" }, { "Text": "For AbbVie:", "": "" }, { "Text": "For Calico:", "": "" }, { "Text": "2. Term. This SOW shall become effective upon the execution hereof by both Parties (the \"SOW Effective Date\"), and shall terminate on the earlier of: (a) the date of completion of all of the obligations of the Parties under this SOW; and (b) expiration or termination of the Agreement.", "": "" }, { "Text": "3. Scope of Services (detailed description of type and amount of Services to be performed):", "": "" }, { "Text": "4. Deliverables/Estimated Timelines:", "": "" }, { "Text": "Services to be Performed", "": "" }, { "Text": "5. Additional Provisions. [Insert additional provisions applicable to SOW, if any]", "": "" }, { "Text": "IN WITNESS WHEREOF, each of the Parties has caused this SOW to be executed by its authorized representative in its name and on its behalf as of the date written beneath its representative's name below.", "": "" }, { "Text": "CALICO LIFE SCIENCES LLC", "": "" }, { "Text": "By:", "": "" }, { "Text": "Name:", "": "" }, { "Text": "Title:", "": "" }, { "Text": "Date:", "": "" }, { "Text": "CALICO LLC", "": "" }, { "Text": "By:", "": "" }, { "Text": "Name:", "": "" }, { "Text": "Title:", "": "" }, { "Text": "Date:", "": "" }, { "Text": "ABBVIE BIOTECHNOLOGY LIMITED", "": "" }, { "Text": "By:", "": "" }, { "Text": "Name:", "": "" }, { "Text": "Title:", "": "" }, { "Text": "Date:", "": "" }, { "Text": "99450416_50", "": "" }, { "Text": "Execution Version", "": "" }, { "Text": "CO-DEVELOPMENT AND LICENSE AGREEMENT", "": "" }, { "Text": "Between", "": "" }, { "Text": "GEDEON RICHTER PLC.", "": "" }, { "Text": "and", "": "" }, { "Text": "ABBVIE GLOBAL ENTERPRISES LTD.", "": "" }, { "Text": "Dated as of March 10, 2022", "": "" }, { "Text": "Confidential Confidential", "": "" }, { "Text": "TABLE OF CONTENTS", "": "" }, { "Text": "ARTICLE 1 DEFINITIONS ........................................................................................................... 1", "": "" }, { "Text": "ARTICLE 2 COLLABORATION MANAGEMENT .................................................................. 28", "": "" }, { "Text": "2.1 Joint Steering Committee ............................................................................................... 28", "": "" }, { "Text": "2.2 General Provisions of the JSC ....................................................................................... 30", "": "" }, { "Text": "2.3 Discontinuation of Participation on a Committee .......................................................... 33", "": "" }, { "Text": "2.4 Interactions Between a Joint Committee and Internal Teams ....................................... 33", "": "" }, { "Text": "2.5 Working Groups............................................................................................................. 33", "": "" }, { "Text": "2.6 Expenses ........................................................................................................................ 33", "": "" }, { "Text": "ARTICLE 3 DEVELOPMENT AND REGULATORY .............................................................. 33", "": "" }, { "Text": "3.1 Discovery Programs ....................................................................................................... 33", "": "" }, { "Text": "3.2 IND-Enabling Studies .................................................................................................... 35", "": "" }, { "Text": "3.3 Clinical Development Activities .................................................................................... 36", "": "" }, { "Text": "3.4 Required Richter Territory Development Activities...................................................... 38", "": "" }, { "Text": "3.5 Development and Regulatory Diligence ........................................................................ 39", "": "" }, { "Text": "3.6 Pre-Clinical and Clinical Supply of Licensed Compounds or Licensed Products; Subcontracting ............................................................................................................... 39", "": "" }, { "Text": "3.7 Subcontracting ............................................................................................................... 41", "": "" }, { "Text": "3.8 Supply of Technology for Development Purposes ........................................................ 41", "": "" }, { "Text": "3.9 Development Costs ........................................................................................................ 42", "": "" }, { "Text": "3.10 Regulatory Matters......................................................................................................... 46", "": "" }, { "Text": "ARTICLE 4 COMMERCIALIZATION ...................................................................................... 49", "": "" }, { "Text": "4.1 In General....................................................................................................................... 49", "": "" }, { "Text": "4.2 Diligence ........................................................................................................................ 50", "": "" }, { "Text": "4.3 Booking of Sales; Distribution ...................................................................................... 50", "": "" }, { "Text": "4.4 Coordination of Commercialization Activities .............................................................. 50", "": "" }, { "Text": "4.5 Pricing; Reimbursement Approvals ............................................................................... 50", "": "" }, { "Text": "4.6 Diversion ........................................................................................................................ 51", "": "" }, { "Text": "4.7 Product Trademarks ....................................................................................................... 51", "": "" }, { "Text": "4.8 Markings ........................................................................................................................ 51", "": "" }, { "Text": "4.9 Manufacturing ................................................................................................................ 52", "": "" }, { "Text": "4.10 Compliance .................................................................................................................... 57", "": "" }, { "Text": "ARTICLE 5 GRANT OF RIGHTS .............................................................................................. 58", "": "" }, { "Text": "5.1 Grants to AbbVie ........................................................................................................... 58", "": "" }, { "Text": "5.2 Grants to Richter ............................................................................................................ 58", "": "" }, { "Text": "5.3 Sublicenses ..................................................................................................................... 59", "": "" }, { "Text": "5.4 Distributorships .............................................................................................................. 60", "": "" }, { "Text": "5.5 Retention of Rights ........................................................................................................ 61", "": "" }, { "Text": "5.6 Confirmatory Patent License ......................................................................................... 61", "": "" }, { "Text": "5.7 Richter Activities in the Territory .................................................................................. 61", "": "" }, { "Text": "5.8 Exclusivity ..................................................................................................................... 61", "": "" }, { "Text": "5.9 In-License Agreements .................................................................................................. 65", "": "" }, { "Text": "5.10 Existing Collaboration Agreement ................................................................................ 67", "": "" }, { "Text": "ARTICLE 6 PAYMENTS AND RECORDS ............................................................................... 67", "": "" }, { "Text": "6.1 Upfront Payment ............................................................................................................ 67", "": "" }, { "Text": "6.2 Development and Regulatory Milestones ...................................................................... 67", "": "" }, { "Text": "6.3 Sales-Based Milestones ................................................................................................. 68", "": "" }, { "Text": "6.4 Royalties ........................................................................................................................ 69", "": "" }, { "Text": "6.5 Royalty Payments and Reports ...................................................................................... 72", "": "" }, { "Text": "6.6 Mode of Payment; Offsets ............................................................................................. 72", "": "" }, { "Text": "6.7 Accounting Procedures .................................................................................................. 72", "": "" }, { "Text": "6.8 Withholding Taxes ......................................................................................................... 72", "": "" }, { "Text": "6.9 Indirect Taxes................................................................................................................. 73", "": "" }, { "Text": "6.10 Interest on Late Payments .............................................................................................. 73", "": "" }, { "Text": "6.11 Financial Records........................................................................................................... 73", "": "" }, { "Text": "6.12 Audit .............................................................................................................................. 74", "": "" }, { "Text": "6.13 Audit Dispute ................................................................................................................. 74", "": "" }, { "Text": "6.14 Confidentiality ............................................................................................................... 74", "": "" }, { "Text": "6.15 Diagnostic or Veterinary Products ................................................................................. 75", "": "" }, { "Text": "6.16 No Other Compensation ................................................................................................ 75", "": "" }, { "Text": "6.17 No Limitation ................................................................................................................. 75", "": "" }, { "Text": "ARTICLE 7 INTELLECTUAL PROPERTY .............................................................................. 75", "": "" }, { "Text": "7.1 Ownership of Intellectual Property ................................................................................ 75", "": "" }, { "Text": "7.2 Maintenance and Prosecution of Patents ....................................................................... 76", "": "" }, { "Text": "7.3 Enforcement of Patents .................................................................................................. 79", "": "" }, { "Text": "7.4 Infringement Claims by Third Parties ............................................................................ 82", "": "" }, { "Text": "7.5 Invalidity or Unenforceability Defenses or Actions ...................................................... 83", "": "" }, { "Text": "7.6 Product Trademarks ....................................................................................................... 84", "": "" }, { "Text": "7.7 Inventor's Remuneration ............................................................................................... 85", "": "" }, { "Text": "7.8 Nonproprietary Name .................................................................................................... 85", "": "" }, { "Text": "7.9 Common Interest ............................................................................................................ 86", "": "" }, { "Text": "ARTICLE 8 PHARMACOVIGILANCE AND SAFETY ........................................................... 86", "": "" }, { "Text": "8.1 Pharmacovigilance ......................................................................................................... 86", "": "" }, { "Text": "8.2 Global Safety Database .................................................................................................. 86", "": "" }, { "Text": "8.3 Data Privacy and Security .............................................................................................. 87", "": "" }, { "Text": "ARTICLE 9 CONFIDENTIALITY AND NON-DISCLOSURE ................................................ 87", "": "" }, { "Text": "9.1 Product Information ....................................................................................................... 87", "": "" }, { "Text": "9.2 Confidentiality Obligations ............................................................................................ 87", "": "" }, { "Text": "9.3 Permitted Disclosures .................................................................................................... 88", "": "" }, { "Text": "9.4 Use of Name .................................................................................................................. 90", "": "" }, { "Text": "9.5 Public Announcements .................................................................................................. 90", "": "" }, { "Text": "9.6 Publications .................................................................................................................... 91", "": "" }, { "Text": "9.7 Return of Confidential Information ............................................................................... 91", "": "" }, { "Text": "9.8 Survival .......................................................................................................................... 92", "": "" }, { "Text": "ARTICLE 10 REPRESENTATIONS AND WARRANTIES ...................................................... 92", "": "" }, { "Text": "10.1 Mutual Representations and Warranties ........................................................................ 92", "": "" }, { "Text": "10.2 Additional Representations and Warranties of Richter ................................................. 93", "": "" }, { "Text": "10.3 Additional Representations and Warranties of AbbVie................................................. 98", "": "" }, { "Text": "10.4 DISCLAIMER OF WARRANTIES .............................................................................. 99", "": "" }, { "Text": "ARTICLE 11 INDEMNITY ......................................................................................................... 99", "": "" }, { "Text": "11.1 Indemnification of Richter ............................................................................................. 99", "": "" }, { "Text": "11.2 Indemnification of AbbVie .......................................................................................... 100", "": "" }, { "Text": "11.3 Certain Losses .............................................................................................................. 101", "": "" }, { "Text": "11.4 Notice of Claim ............................................................................................................ 101", "": "" }, { "Text": "11.5 Control of Defense ....................................................................................................... 101", "": "" }, { "Text": "11.6 Special, Indirect, and Other Losses.............................................................................. 103", "": "" }, { "Text": "11.7 Insurance ...................................................................................................................... 103", "": "" }, { "Text": "ARTICLE 12 TERM AND TERMINATION ............................................................................ 103", "": "" }, { "Text": "12.1 HSR and Other Governmental Filings ......................................................................... 103", "": "" }, { "Text": "12.2 Term ............................................................................................................................. 104", "": "" }, { "Text": "12.3 Termination for Material Breach ................................................................................. 104", "": "" }, { "Text": "12.4 Additional Termination Rights by AbbVie.................................................................. 106", "": "" }, { "Text": "12.5 Termination for Insolvency .......................................................................................... 106", "": "" }, { "Text": "12.6 Rights in Bankruptcy ................................................................................................... 106", "": "" }, { "Text": "12.7 Effect of Termination in its Entirety ............................................................................ 107", "": "" }, { "Text": "12.8 Termination of Terminated Territory; Discovery Program; or Licensed Product ....... 108", "": "" }, { "Text": "12.9 Reversion Royalty. ....................................................................................................... 109", "": "" }, { "Text": "12.10 Transition Agreement .................................................................................................. 110", "": "" }, { "Text": "12.11 Remedies ...................................................................................................................... 111", "": "" }, { "Text": "12.12 Accrued Rights; Surviving Obligations ....................................................................... 111", "": "" }, { "Text": "ARTICLE 13 MISCELLANEOUS ............................................................................................ 113", "": "" }, { "Text": "13.1 Force Majeure .............................................................................................................. 113", "": "" }, { "Text": "13.2 Change in Control ........................................................................................................ 113", "": "" }, { "Text": "13.3 Export Control ............................................................................................................. 114", "": "" }, { "Text": "13.4 Assignment .................................................................................................................. 114", "": "" }, { "Text": "13.5 Severability .................................................................................................................. 114", "": "" }, { "Text": "13.6 Governing Law, Jurisdiction and Service .................................................................... 115", "": "" }, { "Text": "13.7 Dispute Resolution ....................................................................................................... 115", "": "" }, { "Text": "13.8 Notices ......................................................................................................................... 116", "": "" }, { "Text": "13.9 Entire Agreement; Amendments.................................................................................. 117", "": "" }, { "Text": "13.10 English Language......................................................................................................... 117", "": "" }, { "Text": "13.11 Equitable Relief ........................................................................................................... 118", "": "" }, { "Text": "13.12 Waiver and Non-Exclusion of Remedies ..................................................................... 118", "": "" }, { "Text": "13.13 No Benefit to Third Parties .......................................................................................... 118", "": "" }, { "Text": "13.14 Further Assurance ........................................................................................................ 118", "": "" }, { "Text": "13.15 Relationship of the Parties ........................................................................................... 118", "": "" }, { "Text": "13.16 Performance by Affiliates ............................................................................................ 119", "": "" }, { "Text": "13.17 Counterparts; Facsimile Execution .............................................................................. 119", "": "" }, { "Text": "13.18 References .................................................................................................................... 119", "": "" }, { "Text": "13.19 Schedules ..................................................................................................................... 119", "": "" }, { "Text": "13.20 Construction ................................................................................................................. 119", "": "" }, { "Text": "SCHEDULES", "": "" }, { "Text": "Schedule 1.54 Corporate Names", "": "" }, { "Text": "Schedule 1.56 D3 Receptor Compound", "": "" }, { "Text": "Schedule 1.59 D3 Receptor Discovery Program Plan", "": "" }, { "Text": "Schedule 1.106 Identified Indications", "": "" }, { "Text": "Schedule 1.134 Manufacturing Cost", "": "" }, { "Text": "Schedule 1.164 Pro-metabolite Compounds", "": "" }, { "Text": "Schedule 1.167 Pro-metabolite Discovery Program Plan", "": "" }, { "Text": "Schedule 1.197 Richter Territory", "": "" }, { "Text": "Schedule 3.6.1 Draft Development Manufacturing Plan", "": "" }, { "Text": "Schedule 3.9.5 FTE Rates", "": "" }, { "Text": "Schedule 4.9.1(a) Principal Terms of Richter Supply Agreement", "": "" }, { "Text": "Schedule 4.9.2(a) Principal Terms of AbbVie Supply Agreement", "": "" }, { "Text": "Schedule 9.5 Form of Press Release", "": "" }, { "Text": "Schedule 10.2.1 Existing Patents", "": "" }, { "Text": "Schedule 12.9.1 Reversion Royalties Dispute Resolution", "": "" }, { "Text": "Schedule 13.7.3 ADR Procedures", "": "" }, { "Text": "CO-DEVELOPMENT AND LICENSE AGREEMENT", "": "" }, { "Text": "This Co-Development and License Agreement (the \"Agreement\") is made and entered into effective as of March 10, 2022 (the \"Execution Date\") by and between Gedeon Richter Plc., a public limited company organized under the laws of Hungary located at Gyömrői út 19-21, Budapest, 1103, Hungary (\"Richter\"), AbbVie Global Enterprises Ltd., a Bermuda company located at 16 Church Street, Hamilton HM 11 Bermuda (\"AbbVie\"), and, for purposes of Section 5.10 only, (a) Gedeon Richter USA, Inc. a wholly owned subsidiary of Richter, organized under the laws of the State of Delaware, USA and having its principal offices at 119 Cherry Hill Road, Suite 325 Parsippany, New Jersey 07054, USA and (b) Allergan Pharmaceuticals International Limited, a company incorporated and registered in Ireland, with a business address of Clonshaugh Business & Technology Park, Dublin 17, Ireland and with company number 334821. Richter and AbbVie are sometimes referred to herein individually as a \"Party\" and collectively as the \"Parties.", "": "" }, { "Text": "RECITALS", "": "" }, { "Text": "WHEREAS, The Parties wish to collaborate with respect to the discovery and development of Licensed Compounds (as defined herein) and Licensed Products (as defined herein);", "": "" }, { "Text": "WHEREAS, Richter Controls (as defined herein) certain intellectual property rights with respect to the Licensed Compounds; and", "": "" }, { "Text": "WHEREAS, Richter wishes to grant, and AbbVie wishes to take, a license under such intellectual property rights to develop and commercialize Licensed Products in the Territory, in each case in accordance with the terms and conditions set forth below.", "": "" }, { "Text": "NOW, THEREFORE, in consideration of the premises and the mutual promises and conditions hereinafter set forth, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, do hereby agree as follows:", "": "" }, { "Text": "ARTICLE 1 DEFINITIONS", "": "" }, { "Text": "Unless otherwise specifically provided herein, the following terms shall have the following meanings:", "": "" }, { "Text": "1.1 \"AbbVie\" has the meaning set forth in the preamble hereto.", "": "" }, { "Text": "1.2 \"AbbVie Formulation Manufacturing Process\" has the meaning set forth in Section 4.9.3(b).", "": "" }, { "Text": "1.3 \"AbbVie Formulation Manufacturing Technology Transfer\" has the meaning set forth in Section 4.9.3(b).", "": "" }, { "Text": "1.4 \"AbbVie Grantback License\" has the meaning set forth in Section 12.12.1.", "": "" }, { "Text": "1.5 \"AbbVie Grantback Technology\" has the meaning set forth in Section 12.7.1(c).", "": "" }, { "Text": "1.6 \"AbbVie Indemnitees\" has the meaning set forth in Section 11.2.", "": "" }, { "Text": "1.7 \"AbbVie Know-How\" means all Information that is (a) Controlled by AbbVie or any of its Affiliates during the Term, (b) developed or acquired under this Agreement by AbbVie or any of its Affiliates or Sublicensees after the Effective Date and during the Term, (c) not generally known and (d) reasonably necessary or useful for the Development, Manufacture, or Commercialization of a Licensed Compound or a Licensed Product, but excluding any Joint Know-How or any Information published in AbbVie Patents or Joint Patents.", "": "" }, { "Text": "1.8 \"AbbVie Patents\" means all of the Patents that (a) are Controlled by AbbVie or any of its Affiliates during the Term, (b) claim inventions made or conceived under this Agreement by or on behalf of AbbVie or any of its Affiliates after the Effective Date and during the Term, and (c) are reasonably necessary or useful (or, with respect to patent applications, would be reasonably necessary or useful if such patent applications were to issue as patents) for the Development, Manufacture, or Commercialization of a Licensed Compound or a Licensed Product, but excluding any Joint Patents.", "": "" }, { "Text": "1.9 \"AbbVie Product Trademarks\" means (a) the Trademark(s) to be owned and used by AbbVie or its Affiliates or its or their respective Sublicensees for the Development or Commercialization of Licensed Products in the AbbVie Territory and (b) any registrations thereof or any pending applications relating thereto in the AbbVie Territory (excluding, in any event, any trademarks, service marks, names or logos that include any corporate name or logo of the Parties or their Affiliates).", "": "" }, { "Text": "1.10 \"AbbVie Proprietary Manufacturing Information\" has the meaning set forth in Section 4.9.3(c).", "": "" }, { "Text": "1.11 \"AbbVie Prosecuted Infringements\" has the meaning set forth in Section 7.3.1(b).", "": "" }, { "Text": "1.12 \"AbbVie Supply Agreement\" has the meaning set forth in Section 4.9.2(a).", "": "" }, { "Text": "1.13 \"AbbVie Territory\" means worldwide, except for the Richter Territory.", "": "" }, { "Text": "1.14 \"Accounting Standards\" means, with respect to a Party, that such Party shall maintain records and books of accounts in accordance with (a) United States Generally Accepted Accounting Principles or (b) to the extent applicable International Financial Reporting Standards as issued by the International Accounting Standards Board, in each case, consistently applied.", "": "" }, { "Text": "1.15 \"ADR\" has the meaning set forth in Section 13.7.1.", "": "" }, { "Text": "1.16 \"Adverse Ruling\" has the meaning set forth in Section 12.3.1.", "": "" }, { "Text": "1.17 \"Affiliate\" means, with respect to a Party, any Person that, directly or indirectly, through one (1) or more intermediaries, controls, is controlled by or is under common control with such Party. For purposes of this definition, \"control\" and, with correlative meanings, the terms \"controlled by\" and \"under common control with\" means (a) the possession, directly or indirectly, of the power to direct the management or policies of a Person, whether through the ownership of voting securities, by contract relating to voting rights or corporate governance, or otherwise; or (b) the ownership, directly or indirectly, of at least fifty percent (50%) of the voting securities or other ownership interest of a Person (or, with respect to a limited partnership or other similar entity, its general partner or controlling entity). The Parties acknowledge that in the case of certain entities organized under the laws of certain countries outside of the United States, the maximum percentage ownership permitted by law for a foreign investor may be less than fifty percent (50%), and that solely in such cases, such lower percentage shall be substituted in the preceding sentence, provided that such foreign investor has the power to direct the management or policies of such entity.", "": "" }, { "Text": "1.18 \"Agreement\" has the meaning set forth in the preamble hereto.", "": "" }, { "Text": "1.19 \"Alliance Manager\" has the meaning set forth in Section 2.2.5.", "": "" }, { "Text": "1.20 \"ANDA Act\" has the meaning set forth in Section 7.3.3.", "": "" }, { "Text": "1.21 \"Annual Net Sales Milestone Threshold\" has the meaning set forth in Section 6.3.1.", "": "" }, { "Text": "1.22 \"Annual Net Sales-Based Milestone Payment\" has the meaning set forth in Section 6.3.1.", "": "" }, { "Text": "1.23 \"Annual Net Sales-Based Milestone Payment Date\" has the meaning set forth in Section 6.3.1.", "": "" }, { "Text": "1.24 \"Annual Net Sales-Based Milestone Table\" has the meaning set forth in Section 6.3.1.", "": "" }, { "Text": "1.25 \"API\" means, in respect of a Licensed Compound or Licensed Product, the active pharmaceutical ingredient for that Licensed Compound or Licensed Product.", "": "" }, { "Text": "1.26 \"Applicable Law\" means federal, state, local, national and supra-national laws, statutes, rules, and regulations, including any rules, regulations, guidelines, or other requirements of the Regulatory Authorities, major national securities exchanges or major securities listing organizations, that may be in effect from time to time during the Term and applicable to a particular activity or country or other jurisdiction hereunder.", "": "" }, { "Text": "1.27 \"Applicable Territory\" means (a) with respect to AbbVie, the AbbVie Territory and (b) with respect to Richter, the Richter Territory.", "": "" }, { "Text": "1.28 \"Audit Arbitrator\" has the meaning set forth in Section 6.13.", "": "" }, { "Text": "1.29 \"Backup Compound\" has the meaning set forth in Section 3.1.1(c).", "": "" }, { "Text": "1.30 \"Bankruptcy Code\" has the meaning set forth in Section 12.6.1.", "": "" }, { "Text": "1.31 \"Bayh-Dole Act\" means the Patent and Trademark Law Amendments Act of 1980, as amended, codified at 35 U.S.C. §§ 200-212, as amended, as well as any regulations promulgated pursuant thereto, including in 37 C.F.R. Part 401.", "": "" }, { "Text": "1.32 \"Bioequivalence Study\" means a Clinical Study to establish the bioequivalence of (a) a new formulation of a Licensed Product to (b) an existing formulation of such Licensed Product, which Clinical Study meets the requirements of Title 21 CFR Part 320 or foreign equivalent thereof.", "": "" }, { "Text": "1.33 \"Board of Directors\" has the meaning set forth in the definition of \"Change in Control.", "": "" }, { "Text": "1.34 \"Breaching Party\" has the meaning set forth in Section 12.3.1.", "": "" }, { "Text": "1.35 \"Business Day\" means a day other than a Saturday or Sunday on which banking institutions in Chicago, Illinois and Budapest, Hungary are open for business.", "": "" }, { "Text": "1.36 \"Calendar Quarter\" means each successive period of three (3) calendar months commencing on January 1, April 1, July 1 and October 1, except that the first Calendar Quarter of the Term shall commence on the Effective Date and end on the day immediately prior to the first to occur of January 1, April 1, July 1 or October 1 after the Effective Date, and the last Calendar Quarter shall end on the last day of the Term.", "": "" }, { "Text": "1.37 \"Calendar Year\" means each successive period of twelve (12) calendar months commencing on January 1 and ending on December 31, except that the first Calendar Year of the Term shall commence on the Effective Date and end on December 31 of the year in which the Effective Date occurs and the last Calendar Year of the Term shall commence on January 1 of the year in which the Term ends and end on the last day of the Term.", "": "" }, { "Text": "1.38 \"Change in Control\" with respect to a Party, shall be deemed to have occurred if any of the following occurs after the Effective Date:", "": "" }, { "Text": "1.38.1 any Third Party \"person\" or \"group\" (as such terms are defined below) acquires or becomes the \"beneficial owner\" (as defined below), directly or indirectly, of (a) shares of capital stock or other interests (including partnership interests) of such Party then outstanding and normally entitled (without regard to the occurrence of any contingency) to vote in the election of the directors, managers or similar supervisory positions (\"Voting Stock\") of such Party representing fifty percent (50%) or more of the total voting power of all outstanding classes of Voting Stock of such Party or (b) the power to elect a majority of the members of the Party's board of directors, or similar governing body (\"Board of Directors\"); the Parties acknowledge that in the case of certain entities organized under the laws of certain countries outside of the United States, the maximum percentage ownership permitted by law for a foreign investor may be less than fifty percent (50%), and that, solely in such cases, such lower percentage shall be substituted in the preceding sentence, provided that such foreign investor has the power to direct the management or policies of such entity; or", "": "" }, { "Text": "1.38.2 such Party enters into a merger, consolidation or similar transaction with a Third Party (whether or not such Party is the surviving entity) and as a result of such merger, consolidation or similar transaction (a) the members of the Board of Directors of such Party immediately prior to such transaction constitute less than a majority of the members of the Board of Directors of such Party or such surviving Person immediately following such transaction or (b) the Persons that beneficially owned, directly or indirectly, the shares of Voting Stock of such Party immediately prior to such transaction cease to beneficially own, directly or indirectly, shares of Voting Stock of such Party representing at least a majority of the total voting power of all outstanding classes of Voting Stock of the surviving Person in substantially the same proportions as their ownership of Voting Stock of such Party immediately prior to such transaction; or", "": "" }, { "Text": "1.38.3 such Party sells or transfers to any Third Party, in one (1) or more related transactions, properties or assets representing all or substantially all of such Party's consolidated total assets to which this Agreement relates; or", "": "" }, { "Text": "1.38.4 the holders of capital stock of such Party approve a plan or proposal for the liquidation or dissolution of such Party.", "": "" }, { "Text": "For the purpose of this definition of Change in Control, (a) \"person\" and \"group\" have the meanings given such terms under Section 13(d) and 14(d) of the United States Securities Exchange Act of 1934 and the term \"group\" includes any group acting for the purpose of acquiring, holding or disposing of securities within the meaning of Rule 13d-5(b)(1) under the said Act; (b) a \"beneficial owner\" shall be determined in accordance with Rule 13d-3 under the aforesaid Act; and (c) the terms \"beneficially owned\" and \"beneficially own\" shall have meanings correlative to that of \"beneficial owner.", "": "" }, { "Text": "1.39 \"Clinical Data\" means all Information with respect to any Licensed Compound or Licensed Product and made, collected, or otherwise generated under or in connection with the Clinical Studies, Clinical Development Activities, or PAC Studies, including any data (including raw data), reports, and results with respect thereto.", "": "" }, { "Text": "1.40 \"Clinical Development Activities\" has the meaning set forth in Section 3.3.1.", "": "" }, { "Text": "1.41 \"Clinical Development Plan\" means a development plan setting forth in reasonable detail specific Clinical Studies and other Party Development Activities to be performed by AbbVie with respect to any Licensed Product.", "": "" }, { "Text": "1.42 \"Clinical Studies\" means Phase 0 Studies, Phase I Studies, Phase II Studies, Phase III Studies, PAC Studies and such other tests and studies in human subjects that are required by Applicable Law, or otherwise recommended by the Regulatory Authorities, to obtain or maintain any Regulatory Approval for a Licensed Product for one (1) or more indications, including tests or studies that are intended to expand the Product Labeling for such Licensed Product with respect to such indication.", "": "" }, { "Text": "1.43 \"Combination Product\" means a Licensed Product that is comprised of or contains one (1) or more Licensed Compounds as an active ingredient together with one (1) or more other active ingredients, whether in the same or different formulations, and is sold either as a fixed dose or as separate doses as one (1) product.", "": "" }, { "Text": "1.44 \"Commercialization\" means any and all activities related to the preparation for sale of, offering for sale of, or sale of a Licensed Compound or Licensed Product, including activities related to marketing, promoting, distributing, importing and exporting such Licensed Compound or Licensed Product, and, for purposes of setting forth the rights and obligations of the Parties under this Agreement, shall be deemed to include conducting Medical Affairs Activities, and interacting with Regulatory Authorities or other Governmental Authorities regarding any of the foregoing. When used as a verb, \"to Commercialize\" and \"Commercializing\" means to engage in Commercialization, and \"Commercialized\" has a corresponding meaning.", "": "" }, { "Text": "1.45 \"Commercially Reasonable Efforts\" means, with respect to the performance of Development, Commercialization, or Manufacturing activities with respect to a Licensed Compound or Licensed Product by a Party, the carrying out of such activities using efforts and resources comparable to the efforts and resources that such Party would typically devote to compounds or products of similar market potential at a similar stage in development or product life, taking into account all scientific, commercial, and other factors that the Party would take into account, including issues of safety and efficacy, expected and actual cost and time to develop, expected and actual profitability (including royalties and other payments required hereunder), expected and actual competitiveness of alternative products (including generic or biosimilar products), the nature and extent of expected and actual market exclusivity (including patent coverage and regulatory exclusivity), the expected likelihood of regulatory approval, the expected and actual reimbursability and pricing, and the expected and actual amounts of marketing and promotional expenditures required. \"Commercially Reasonable Efforts\" shall be determined on a country-by-country (or region-by-region, where applicable) and Indication-by-Indication basis, except that the Party may consider the impact of its efforts and resources expended with respect to any country (or region) on any other country (or region). To the extent that the performance of a Party's obligations hereunder is adversely affected by the other Party's failure to perform its obligations hereunder, the impact of such performance failure will be taken into account in determining whether such Party has used its Commercially Reasonable Efforts to perform any such affected obligation.", "": "" }, { "Text": "1.46 \"Competing Generic Product\" means, with respect to a Competing Product that is sold by a Third Party under a Drug Approval Application granted to such Third Party by a Regulatory Authority in a country or jurisdiction, any product that; (a) contains a compound, molecule or other therapeutic that is or that generates a D3 Receptor Modulator, other than cariprazine, as an active ingredient; and (b) is approved for sale in such country or jurisdiction in reliance, in whole or in part, on the prior approval (or on safety or efficacy data submitted in support of the prior approval) of such Competing Product as determined by such Regulatory Authority, including any product authorized for sale (i) in the EU pursuant to a provision of Articles 10, 10a or 10b of Parliament and Council Directive 2001/83/EC as amended (including an application under Article 6.1 of Parliament and Council Regulation (EC) No 726/2004 that relies for its content on any such provision), or (ii) in any other country or jurisdiction, pursuant to all equivalents of such provisions or of Section 505(b)(2) or Section 505(j) of the FFDCA (21 U.S.C. 355(b)(2) and 21 U.S.C. 355(j)), including any amendments and successor statutes with respect to the subsections (i) through (ii) thereto.", "": "" }, { "Text": "1.47 \"Competing Product\" means any D3 Receptor Modulator Competing Product or Pro-Metabolite Competing Product.", "": "" }, { "Text": "1.48 \"Competitive Acquisition\" means a transaction in which a Party acquires a Third Party (whether such acquisition occurs by way of a purchase of assets, merger, consolidation, change of control, or otherwise), other than by way of a Change in Control of such Party, where such Third Party, as of immediately prior to the consummation of such acquisition, is researching, developing or commercializing any product in the anti-psychotic field (other than a Competing Generic Product or other generic product acquired by Richter for research, development or commercialization in the Richter Territory).", "": "" }, { "Text": "1.49 \"Conduct\" means, with respect to any Clinical Study or PAC Study, to (a) sponsor, support or perform, directly or indirectly through a Third Party, such Clinical Study or PAC Study; or (b) provide to a Third Party funding for, or clinical supplies (including placebos) for use in, such Clinical Study or PAC Study.", "": "" }, { "Text": "1.50 \"Confidential Information\" means any Information or data provided orally, visually, in writing or other form by or on behalf of one (1) Party (or an Affiliate or representative of such Party) to the other Party (or to an Affiliate or representative of such Party) in connection with this Agreement, whether prior to, on, or after the Effective Date, including Information relating to the terms of this Agreement, any Licensed Compound or Licensed Product (including the Regulatory Documentation and Regulatory Data), any Exploitation of any Licensed Compound or Licensed Product, any know-how with respect thereto developed by or on behalf of the disclosing Party or its Affiliates (including AbbVie Know-How and Richter Know-How, as applicable), or the scientific, regulatory or business affairs or other activities of either Party. In addition, each Party's \"Confidential Information,\" as such term is defined under the Existing Confidentiality Agreement will be deemed to be such Party's Confidential Information under this Agreement. Notwithstanding the foregoing, (a) Joint Know-How shall be deemed to be the Confidential Information of both Parties, and both Parties shall be deemed to be the receiving Party and the disclosing Party with respect thereto, and (b) all Regulatory Documentation owned by AbbVie pursuant to Section 3.10.1 shall be deemed to be the Confidential Information of AbbVie, and AbbVie shall be deemed to be the disclosing Party and Richter shall be deemed to be the receiving Party with respect thereto.", "": "" }, { "Text": "1.51 \"Control\" means, with respect to any item of Information, Regulatory Documentation, material, Patent, or other property right, the possession of the right, whether directly or indirectly, and whether by ownership, license, covenant not to sue or otherwise (other than by operation of the license and other grants in Section 5.1 or Section 5.2), to grant a license, sublicense or other right (including the right to reference Regulatory Documentation) to or under such Information, Regulatory Documentation, material, Patent, or other property right as provided for herein without violating the terms of any agreement or other arrangement with any Third Party.", "": "" }, { "Text": "1.52 \"Convicted Entity\" has the meaning set forth in Section 10.2.21(d).", "": "" }, { "Text": "1.53 \"Convicted Individual\" has the meaning set forth in Section 10.2.21(d).", "": "" }, { "Text": "1.54 \"Corporate Names\" means (a) with respect to Richter, the Trademarks and logos identified on Schedule 1.54(a) and such other names and logos as Richter may designate in writing from time to time and (b) with respect to AbbVie, the Trademarks and logos identified on Schedule 1.54(b) and such other names and logos as AbbVie may designate in writing from time to time.", "": "" }, { "Text": "1.55 \"D3 Receptor\" means all forms of the polypeptide designated as dopamine receptor 3, corresponding to the human dopamine 3 receptor protein (as exemplified in National Center for Biotechnology Information also identified as UniProtKB:P35462, X5D2G4, E9PCM4, A1A4V4, Q13167, Q9BXX6, X5DP70, Q9NY31, A8K8E4, Q16045; HGNC: HGNC:3024; Entrez Gene: Gene ID: 1814; Ensembl: ENSG00000151577 etc.), and all forms of the protein (including isoforms, mutations, conformations, post-translational modifications or other forms thereof) in human and other species, encoded by the dopamine receptor 3 gene (as exemplified by Entrez gene ID Mus musculus: 13490; Rattus norvegicus: 29238, Ensembl Transcript ID Homo sapiens: DRD3-202: ENST00000383673.5, DRD3-203: ENST00000460779.5, DRD3-204: ENST00000467632.5, DRD3-201: ENST00000295881.9) including all transcript variants.", "": "" }, { "Text": "1.56 \"D3 Receptor Compound\" means any D3 Receptor Modulator Controlled by Richter or any of its Affiliates as of the Effective Date or at any time during the Discovery Program Term, including (a) the compounds set forth on Schedule 1.56 and (b) any compounds identified by Richter during the Discovery Program Term under the D3 Receptor Discovery Program that meet the D3 Receptor Compound Criteria set forth in the D3 Receptor Discovery Program Plan, that is not (i) a compound generated from a Pro-metabolite Compound or (ii) cariprazine, and any metabolite, salt, ester, hydrate, solvate, isomer, enantiomer, free acid form, free base form, crystalline form, co-crystalline form, amorphous form, pro-drug (including ester pro-drug) form, racemate, polymorph, chelate, stereoisomer, tautomer, or optically active form of any of the foregoing.", "": "" }, { "Text": "1.57 \"D3 Receptor Compound Criteria\" means the criteria agreed upon by the Parties for the compound, molecule or other therapeutic identified during the conduct of the D3 Receptor Discovery Program, as set forth in the D3 Receptor Discovery Program Plan.", "": "" }, { "Text": "1.58 \"D3 Receptor Discovery Program\" means the program of discovery and pre-clinical activities for novel D3 Receptor Modulators undertaken as set forth in Section 3.1 and the D3 Receptor Discovery Program Plan.", "": "" }, { "Text": "1.59 \"D3 Receptor Discovery Program Plan\" means the written summary attached hereto as Schedule 1.59 including any amendments thereto, of the specific research activities to be conducted by Richter under the D3 Receptor Discovery Program, the timelines for completion of such activities, and the corresponding D3 Receptor Compound Criteria.", "": "" }, { "Text": "1.60 \"D3 Receptor Modulator\" means any compound, molecule or other therapeutic that binds, agonizes, antagonizes or otherwise modulates the D3 Receptor with a Ki/EC50/IC50/KB value less than 1 micromolar.", "": "" }, { "Text": "1.61 \"D3 Receptor Modulator Competing Product\" means any product that is or contains a compound, molecule or other therapeutic that is a D3 Receptor Modulator, other than cariprazine as exploited pursuant to the Existing Collaboration Agreement.", "": "" }, { "Text": "1.62 \"D3 Receptor Product\" any product containing a D3 Receptor Compound, alone or in combination with one (1) or more other active ingredients, in any and all forms, presentations, delivery systems, dosages, and formulations.", "": "" }, { "Text": "1.63 \"Data Security and Privacy Laws\" means all Applicable Laws relating to the privacy, Processing and security of Personal Data.", "": "" }, { "Text": "1.64 \"Debarred Entity\" has the meaning set forth in Section 10.2.21(d).", "": "" }, { "Text": "1.65 \"Debarred Individual\" has the meaning set forth in Section 10.2.21(a).", "": "" }, { "Text": "1.66 \"Default Notice\" has the meaning set forth in Section 12.3.1.", "": "" }, { "Text": "1.67 \"Development\" means all activities related to research, pre-clinical and other non-clinical testing, test method development and stability testing, toxicology, formulation, process development, manufacturing scale-up, qualification and validation, quality assurance/quality control, Clinical Studies (excluding Phase IV Studies), Bioequivalence Study, including Manufacturing in support thereof, statistical analysis and report writing, the preparation and submission of Drug Approval Applications, regulatory affairs with respect to the foregoing and all other activities necessary or reasonably useful or otherwise requested or required by a Regulatory Authority as a condition or in support of obtaining or maintaining a Regulatory Approval. When used as a verb, \"Develop\" means to engage in Development. Development shall include PAC Studies. For purposes of clarity, Development shall include any submissions and activities required in support thereof, including as required by Applicable Laws or a Regulatory Authority as a condition or in support of obtaining a pricing or reimbursement approval for an approved Licensed Product.", "": "" }, { "Text": "1.68 \"Development Costs\" means the FTE Costs (charged in accordance with Section 3.9) incurred, and the direct out-of-pocket costs recorded as an expense in accordance with Accounting Standards, by or on behalf of a Party or any of its Affiliates after the Execution Date and during the Term that are specifically identifiable or reasonably allocable to Discovery Program Activities, IND-Enabling Activities, or Clinical Development Activities, as the case may be, in accordance with the applicable Discovery Program Plan, IND-Enabling Studies Plan and Budget, or Clinical Development Plan, excluding any Manufacturing Costs. Except in the case of Development Costs incurred in accordance with clause (d) below, Development Costs shall be limited to Discovery Program Activities, IND-Enabling Activities, or Clinical Development Activities, as the case may be, that are specifically identified in the applicable Discovery Program Plan, IND-Enabling Studies Plan and Budget, or Clinical Development Plan; provided, that with respect to costs incurred with respect to IND-Enabling Activities, such costs shall be included in \"Development Costs\" only to the extent less than or equal to the amounts set forth in the applicable IND-Enabling Studies Plan and Budget for such IND-Enabling Activities (subject to permitted overruns pursuant to Section 3.9.2). Subject to the foregoing, Development Costs shall include such costs in connection with the following activities, as applicable:", "": "" }, { "Text": "(a) pre-clinical and non-clinical activities such as toxicology and formulation development, test method development, stability testing, quality assurance, quality control development and statistical analysis;", "": "" }, { "Text": "(b) Clinical Studies for a Licensed Compound or Licensed Product, including (i) the preparation for and Conduct of such clinical trials; (ii) data collection and analysis and report writing; (iii) clinical laboratory work; (iv) regulatory activities in connection with such clinical trials, including adverse event recordation and reporting; and (v) advisory meetings in connection with a Licensed Compound or Licensed Product;", "": "" }, { "Text": "(c) all activities necessary to obtain any Regulatory Approval for a Licensed Product in the AbbVie Territory and filing fees in connection with the filing of applications for any Regulatory Approval in the AbbVie Territory;", "": "" }, { "Text": "(d) Losses incurred in connection with Third Party Claims described in Section 11.3 to the extent such Losses are to be included in Development Costs in accordance with Section 11.3; and", "": "" }, { "Text": "(e) any other activities set forth in the Discovery Program Plan, IND-Enabling Studies Plan and Budget, or Clinical Development Plan.", "": "" }, { "Text": "1.69 \"Development Manufacturing Activities\" has the meaning set forth in Section 3.6.1.", "": "" }, { "Text": "1.70 \"Development Manufacturing Plan\" has the meaning set forth in Section 3.6.1.", "": "" }, { "Text": "1.71 \"Discovery Program Activities\" means the Party Development Activities set forth in the D3 Receptor Discovery Program Plan and Pro-metabolite Discovery Program Plan to be performed by Richter (or, pursuant to Section 3.1.1, AbbVie) in order to attempt to identify at least one (1) Lead Compound and (1) Backup Compound with respect to each Discovery Program.", "": "" }, { "Text": "1.72 \"Discovery Program Cap\" has the meaning set forth in Section 3.9.3(b).", "": "" }, { "Text": "1.73 \"Discovery Program Plan\" means the D3 Receptor Discovery Program Plan and the Pro-metabolite Discovery Program Plan.", "": "" }, { "Text": "1.74 \"Discovery Program Term\" has the meaning set forth in Section 3.1.3.", "": "" }, { "Text": "1.75 \"Discovery Programs\" means the D3 Receptor Discovery Program and the Pro-metabolite Discovery Program.", "": "" }, { "Text": "1.76 \"Dispute\" has the meaning set forth in Section 13.7.", "": "" }, { "Text": "1.77 \"Distributor\" has the meaning set forth in Section 5.3.2.", "": "" }, { "Text": "1.78 \"Divestiture\" means, with respect to a Competing Product, the sale, exclusive license or other transfer by Richter and its Affiliates of all of their development and commercialization rights with respect to such Competing Product to a Third Party without the retention or reservation of any development or commercialization obligation, interest or participation rights (other than solely an economic interest or the right to enforce customary terms and conditions contained in the relevant agreements effectuating such transaction). When used as a verb, \"Divest\" means to engage in a Divestiture.", "": "" }, { "Text": "1.79 \"Dollars\" or \"$\" means United States Dollars.", "": "" }, { "Text": "1.80 \"Drug Approval Application\" means a New Drug Application as defined in the FFDCA, or any corresponding foreign application in the Territory.", "": "" }, { "Text": "1.81 \"Effective Date\" has the meaning set forth in Section 12.2.", "": "" }, { "Text": "1.82 \"Employee Invention\" has the meaning set forth in Section 7.1.5.", "": "" }, { "Text": "1.83 \"European Union\" or \"EU\" means the economic, scientific, and political organization of member states known as the European Union, as its membership may be altered from time to time, and any successor thereto.", "": "" }, { "Text": "1.84 \"Excluded Entity\" has the meaning set forth in Section 10.2.21(c).", "": "" }, { "Text": "1.85 \"Excluded Individual\" has the meaning set forth in Section 10.2.21(c).", "": "" }, { "Text": "1.86 \"Execution Date\" means the date of execution of this Agreement as set forth in the preamble hereto.", "": "" }, { "Text": "1.87 \"Existing Collaboration Agreement\" means that certain (a) License and Cooperation Agreement between Gedeon Richter Plc, Gedeon Richter USA, Inc. and Forest Laboratories Ireland Limited dated November 22, 2004, as amended on February 26, 2009, November 12, 2010, April 28, 2017, June 3, 2019 and June 1, 2021; (b) Letter Agreement, dated October 20, 2006; (c) Letter of Confirmation dated March 17, 2010; (d) Letter Agreement dated June 3, 2010, (e) Letter Agreement dated June 29, 2010, and (f) Letter Agreement dated April 4, 2011.", "": "" }, { "Text": "1.88 \"Existing Confidentiality Agreement\" means that certain Confidential Disclosure Agreement between the Parties or their respective Affiliates dated August 27, 2020.", "": "" }, { "Text": "1.89 \"Existing Patents\" has the meaning set forth in Section 10.2.1.", "": "" }, { "Text": "1.90 \"Existing Regulatory Documentation\" means the Regulatory Documentation Controlled by Richter or any of its Affiliates as of the Effective Date.", "": "" }, { "Text": "1.91 \"Exploit\" or \"Exploitation\" means to make, have made, import, export, use, have used, sell, have sold, or offer for sale, including to Develop, Commercialize, register, modify, enhance, improve, Manufacture, have Manufactured, hold, or keep (whether for disposal or otherwise), or otherwise dispose of.", "": "" }, { "Text": "1.92 \"FDA\" means the United States Food and Drug Administration and any successor agency(ies) or authority having substantially the same function.", "": "" }, { "Text": "1.93 \"FDA's Disqualified/Restricted List\" has the meaning set forth in Section 10.2.21(e).", "": "" }, { "Text": "1.94 \"FFDCA\" means the United States Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., as amended from time to time, together with any rules, regulations and requirements promulgated thereunder (including all additions, supplements, extensions, and modifications thereto).", "": "" }, { "Text": "1.95 \"Field\" means all human and non-human diagnostic, prophylactic, and therapeutic uses.", "": "" }, { "Text": "1.96 \"First Commercial Sale\" means, with respect to a Licensed Product and a country, the first sale for monetary value for use or consumption by the end user of such Licensed Product in such country after all Regulatory Approval for such Licensed Product has been obtained in such country. Sales prior to receipt of all Regulatory Approval for such Licensed Product, such as so-called \"treatment IND sales,\" \"named patient sales,\" and \"compassionate use sales,\" shall not be construed as a First Commercial Sale.", "": "" }, { "Text": "1.97 \"FTE\" means the equivalent of the work of one (1) employee full time for one (1) Calendar Year (consisting of at least a total of eighteen hundred (1800) hours per Calendar Year) of work performing Development or Manufacturing activities for a Licensed Compound or Licensed Product. No additional payment shall be made with respect to any person who works more than eighteen hundred (1800) hours per Calendar Year and any person who devotes less than eighteen hundred (1800) hours per Calendar Year (or such other number as may be agreed by the JSC) shall be treated as an FTE on a pro rata basis based upon the actual number of hours worked divided by eighteen hundred (1800).", "": "" }, { "Text": "1.98 \"FTE Costs\" means, with respect to a Party for any period, the applicable FTE Rate multiplied by the applicable number of FTEs of such Party performing Development or Manufacturing activities during such period in accordance with the applicable Discovery Program Plan, IND-Enabling Studies Plan and Budget, or Clinical Development Plan.", "": "" }, { "Text": "1.99 \"FTE Rate\" means the applicable FTE rate set forth on Schedule 3.9.5 as adjusted pursuant to Section 3.9.5.", "": "" }, { "Text": "1.100 \"Generic Product\" means, with respect to a Licensed Product, any product that (a) is sold by a Third Party under a Drug Approval Application granted by a Regulatory Authority to a Third Party; (b) contains a Licensed Compound as an active ingredient; and (c) is approved in reliance, in whole or in part, on the prior approval (or on safety or efficacy data submitted in support of the prior approval) of such Licensed Product as determined by the applicable Regulatory Authority, including any product authorized for sale (i) in the U.S. pursuant to Section 505(b)(2) or Section 505(j) of the FFDCA (21 U.S.C. 355(b)(2) and 21 U.S.C. 355(j), respectively), or (ii) in any other country or jurisdiction pursuant to all equivalents of such provisions, including any amendments and successor statutes with respect to the subsections (i) through (ii) thereto. A Licensed Product licensed or produced by AbbVie or any of its Affiliates under the same Drug Approval Application owned by AbbVie or any of its Affiliates (i.e., an authorized generic product) will not constitute a Generic Product.", "": "" }, { "Text": "1.101 \"Global Commercialization Plan\" has the meaning set forth in Section 4.1.1.", "": "" }, { "Text": "1.102 \"Good Manufacturing Practice\" or \"GMP\" means all Applicable Laws to the Manufacture of Product, including the current good manufacturing practices as specified in (a) the U.S. Code of Federal Regulations and FDA's guidance documents, and all successor applicable regulations and guidance documents thereto, (b) the EUDRALEX Vol. 4 \"Medicinals for Human and Veterinary Use: Good Manufacturing Practice\", in particular Part II \"Basic Requirements for Active Substances used as Starting Materials\" (03 October 2005), and applicable Annexes to Vol.4, and (c) the ICH (International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use) guidelines, including without limitation, ICH Q7A \"ICH Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients\".", "": "" }, { "Text": "1.103 \"Governmental Authority\" means any multi-national, federal, national, state, provincial, local, municipal or other government authority of any nature (including any governmental division, subdivision, commission, department, bureau, prefecture, agency, branch, office, governmental arbitrator or arbitral body, council, court or other tribunal entitled to exercise any administrative, executive, judicial, legislative, police, regulatory or taxing authority or power).", "": "" }, { "Text": "1.104 \"HSR Act\" means the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended.", "": "" }, { "Text": "1.105 \"HSR Filing\" has the meaning set forth in Section 12.1.", "": "" }, { "Text": "1.106 \"Identified Indications\" means, with respect to a Licensed Product, the Indications set forth on Schedule 1.106.", "": "" }, { "Text": "1.107 \"IND\" means an application filed with a Regulatory Authority for authorization to commence Clinical Studies, including (a) an Investigational New Drug Application as defined in the FFDCA or any successor application or procedure filed with the FDA, (b) any equivalent of a United States IND in other countries or regulatory jurisdictions, (i.e., clinical trial application (CTA)) and (c) all supplements, amendments, variations, extensions and renewals thereof that may be filed with respect to the foregoing.", "": "" }, { "Text": "1.108 \"IND-Enabling Activities\" has the meaning set forth in Section 3.2.1(a).", "": "" }, { "Text": "1.109 \"IND-Enabling Studies\" means all activities for a compound following designation by the JSC as a Lead Compound or Backup Compound pursuant to Section 3.2.2 that are required to select a Licensed Compound or Licensed Product to advance to Clinical Studies, including GLP toxicology studies, API characterization, communications with Regulatory Authorities regarding an IND filing and other activities necessary to support the filing of an IND.", "": "" }, { "Text": "1.110 \"IND-Enabling Studies Criteria\" means the criteria agreed upon by the Parties for determining whether a Lead Compound should progress beyond IND-Enabling Activities to Clinical Studies, as set forth in the IND-Enabling Studies Plan and Budget.", "": "" }, { "Text": "1.111 \"IND-Enabling Studies Plan and Budget\" means a development plan setting forth in reasonable detail specific IND-Enabling Studies to be performed by Richter with respect to the applicable Lead Compound and the budget for such Development activities.", "": "" }, { "Text": "1.112 \"Indemnification Claim Notice\" has the meaning set forth in Section 11.4.", "": "" }, { "Text": "1.113 \"Indemnified Party\" has the meaning set forth in Section 11.4.", "": "" }, { "Text": "1.114 \"Indication\" means, with respect to a Licensed Product, the intended use of such Licensed Product (a) for the treatment, control, mitigation, prevention or cure of a distinct recognized human disease or condition, or of a manifestation of a recognized human disease or condition, or (b) for the relief of symptoms associated with a recognized human disease or condition, and which, in each case ((a) and (b)), if approved in the U.S., would be reflected in the \"Indications and Usage\" section of labeling pursuant to 21 C.F.R. §201.57(c)(2) or, to the extent applicable, any comparable labeling section outside the U.S. Notwithstanding the foregoing, each of the following will be treated as the same Indication and not a distinct Indication: (a) the treatment of a disease, disorder or condition in a particular patient population and the treatment of the same disease, disorder or condition in another population (e.g., adult population and pediatric population), (b) different subtypes or lines of therapy for the same disease, disorder or condition, and (c) label expansions or label changes (including dose, dosing schedule, use in the same Indication in combination with various other agents, etc.) for a given Indication.", "": "" }, { "Text": "1.115 \"Indication Cap\" has the meaning set forth in Section 3.9.2(b).", "": "" }, { "Text": "1.116 \"Indirect Taxes\" has the meaning set forth in Section 6.9.", "": "" }, { "Text": "1.117 \"Information\" means all knowledge of a technical, scientific, business and other nature, including know-how, technology, means, methods, processes, practices, formulae, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings, assembly procedures, computer programs, apparatuses, specifications, data, results, documents and other material, Regulatory Data, and other biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical, pre-clinical, clinical, safety, manufacturing and quality control data and information, including study designs and protocols, reagents (e.g., plasmids, proteins, cell lines, assays and compounds) and biological methodology; in each case (whether or not confidential, proprietary, patented or patentable, of commercial advantage or not) in written, electronic or any other form now known or hereafter developed.", "": "" }, { "Text": "1.118 \"Initiation\" or \"Initiate\" means, with respect to a Clinical Study, the first dosing of the first human subject in such Clinical Study.", "": "" }, { "Text": "1.119 \"In-License Agreement\" means any agreement between Richter and a Third Party under which Richter has in-licensed or otherwise obtained rights in or to any of the Intellectual Property licensed to AbbVie under this Agreement, including such agreements under which AbbVie is granted a sublicense or other right as provided in Section 5.9.2.", "": "" }, { "Text": "1.120 \"In-Licensed Patents\" has the meaning set forth in Section 10.2.3.", "": "" }, { "Text": "1.121 \"Intellectual Property\" has the meaning set forth in Section 12.6.1.", "": "" }, { "Text": "1.122 \"Joint Committees\" has the meaning set forth in Section 2.1.2(t).", "": "" }, { "Text": "1.123 \"Joint Intellectual Property Rights\" has the meaning set forth in Section 7.1.2.", "": "" }, { "Text": "1.124 \"Joint Know-How\" has the meaning set forth in Section 7.1.2.", "": "" }, { "Text": "1.125 \"Joint Patents\" has the meaning set forth in Section 7.1.2.", "": "" }, { "Text": "1.126 \"Joint Steering Committee\" has the meaning set forth in Section 2.1.1.", "": "" }, { "Text": "1.127 \"Knowledge\" means the good faith understanding of the facts and information after reasonable investigation with respect to the relevant facts and information of the Research Director, Director of Regulatory Science Affairs, and Head of Intellectual Property or any personnel holding positions equivalent to such job titles (but only to the extent such positions exist at such Party).", "": "" }, { "Text": "1.128 \"Lead Compound\" means has the meaning set forth in Section 3.1.1(c).", "": "" }, { "Text": "1.129 \"Lead Compound Criteria\" means, with respect to each Discovery Program, the criteria agreed upon by the Parties for the designation of a Licensed Compound as the lead compound, as set forth in the applicable Discovery Program Plan.", "": "" }, { "Text": "1.130 \"Licensed Compound\" means any D3 Receptor Compound or Pro-metabolite Compound that is Developed or Commercialized under this Agreement.", "": "" }, { "Text": "1.131 \"Licensed Product\" means any D3 Receptor Product or Pro-metabolite Product that is Developed or Commercialized under this Agreement.", "": "" }, { "Text": "1.132 \"Losses\" has the meaning set forth in Section 11.1.", "": "" }, { "Text": "1.133 \"Manufacture\" and \"Manufacturing\" means all activities related to the synthesis, making, production, processing, purifying, formulating, filling, finishing, packaging, labeling, shipping, and holding of any Licensed Compound, any Licensed Product, or any intermediate thereof, including process development, process qualification and validation, scale-up, pre-clinical, clinical and commercial production and analytic development, product characterization, stability testing, quality assurance, and quality control.", "": "" }, { "Text": "1.134 \"Manufacturing Cost\" with respect to a Licensed Compound or Licensed Product has the meaning set forth on Schedule 1.134.", "": "" }, { "Text": "1.135 \"Manufacturing Process\" means, as applicable, the AbbVie Formulation Manufacturing Process or the Richter Manufacturing Process.", "": "" }, { "Text": "1.136 \"Manufacturing Technology Transfer\" means, as applicable, the AbbVie Formulation Manufacturing Technology Transfer or the Richter Manufacturing Technology Transfer.", "": "" }, { "Text": "1.137 \"Medical Affairs Activities\" means, with respect to any country or other jurisdiction in the Territory, the coordination of medical information requests and field based medical scientific liaisons with respect to Licensed Compounds or Licensed Products, including activities of medical scientific liaisons and the provision of medical information services with respect to a Licensed Compound or Licensed Product.", "": "" }, { "Text": "1.138 \"Minimum Safety Stock\" has the meaning set forth in Section 4.9.1(b).", "": "" }, { "Text": "1.139 \"Mono Product\" has the meaning set forth in the definition of \"Net Sales.", "": "" }, { "Text": "1.140 \"Necessary Third Party IP\" has the meaning set forth in Section 5.9.1.", "": "" }, { "Text": "1.141 \"Necessary Third Party License\" has the meaning set forth in Section 5.9.1.", "": "" }, { "Text": "1.142 \"Net Sales\" means, with respect to a Licensed Product for any period, the total amount billed or invoiced on sales of such Licensed Product during such period by AbbVie, its Affiliates, or Sublicensees in the AbbVie Territory to Third Parties (including wholesalers or Distributors), in bona fide arm's length transactions, less the following deductions, in each case related specifically to the Licensed Product and actually allowed and taken by such Third Parties and not otherwise recovered by or reimbursed to AbbVie, its Affiliates, or Sublicensees:", "": "" }, { "Text": "(a) trade, cash and quantity discounts;", "": "" }, { "Text": "(b) price reductions or rebates, retroactive or otherwise, imposed by, negotiated with or otherwise paid to governmental authorities or other payees;", "": "" }, { "Text": "(c) taxes on sales (such as sales, value added, or use taxes) to the extent added to the sale price and set forth separately as such in the total amount invoiced;", "": "" }, { "Text": "(d) amounts repaid or credited by reason of rejections, defects, return goods allowance, recalls or returns, or because of retroactive price reductions, including rebates or wholesaler charge backs;", "": "" }, { "Text": "(e) the portion of administrative fees paid during the relevant time period to group purchasing organizations, pharmaceutical benefit managers or Medicare Prescription Drug Plans relating to such Licensed Product;", "": "" }, { "Text": "(f) any invoiced amounts from a prior period which are not collected and are written off by AbbVie or its Affiliates, including bad debts; provided that if such amounts are subsequently collected by AbbVie or its Affiliates then such collected amounts will be subsequently included in Net Sales;", "": "" }, { "Text": "(g) that portion of the annual fee on prescription drug manufacturers imposed by the Patient Protection and Affordable Care Act, Pub. L. No. 111-148 (as amended) and reasonably allocable to sales of the Licensed Products;", "": "" }, { "Text": "(h) freight, insurance, import/export, and other transportation charges to the extent added to the sale price and set forth separately as such in the total amount invoiced, as well as any fees for services provided by wholesalers and warehousing chains related to the distribution of such Licensed Product; and", "": "" }, { "Text": "(i) any other similar and customary deductions that are consistent with Accounting Standards, but which may not be duplicative of the deductions specified in (a) – (h) above.", "": "" }, { "Text": "Net Sales shall not include transfers or dispositions for charitable, compassionate, promotional, pre-clinical, clinical, or regulatory purposes. Net Sales shall include the amount or fair market value of all other consideration received by AbbVie, its Affiliates or Sublicensees in respect of the Licensed Product, whether such consideration is in cash, payment in kind, exchange or other form. Net Sales shall not include sales between or among AbbVie, its Affiliates, or Sublicensees.", "": "" }, { "Text": "Subject to the above, Net Sales shall be calculated in accordance with the standard internal policies and procedures of AbbVie, its Affiliates, or Sublicensees, which must be in accordance with Accounting Standards.", "": "" }, { "Text": "For purposes of calculating Net Sales, all Net Sales shall be converted into Dollars in accordance with Section 6.6.", "": "" }, { "Text": "In the event a Licensed Product is a Combination Product, the Net Sales for such Combination Product shall be calculated as follows:", "": "" }, { "Text": "(i) If AbbVie, its Affiliate, or Sublicensee separately sells in such country or other jurisdiction, (A) a product containing as its sole active ingredient a Licensed Compound contained in such Combination Product (the \"Mono Product\") and (B) products containing as their sole active ingredients the other active ingredients in such Combination Product, the Net Sales attributable to such Combination Product shall be calculated by multiplying actual Net Sales of such Combination Product by the fraction A/(A+B) where: \"A\" is AbbVie's (or its Affiliate's or Sublicensee's, as applicable) average Net Sales price during the period to which the Net Sales calculation applies for the Mono Product in such country or other jurisdiction and \"B\" is AbbVie's (or its Affiliate's or Sublicensee's, as applicable) average Net Sales price during the period to which the Net Sales calculation applies in such country or other jurisdiction, for products that contain as their sole active ingredients the other active ingredients in such Combination Product.", "": "" }, { "Text": "(ii) If AbbVie, its Affiliate, or Sublicensee separately sells in such country or other jurisdiction the Mono Product but does not separately sell in such country or other jurisdiction products containing as their sole active ingredients the other active ingredients in such Combination Product, the Net Sales attributable to such Combination Product shall be calculated by multiplying the Net Sales of such Combination Product by the fraction A/C where: \"A\" is AbbVie's (or its Affiliate's or Sublicensee's, as applicable) average Net Sales price during the period to which the Net Sales calculation applies for the Mono Product in such country or other jurisdiction, and \"C\" is AbbVie's (or its Affiliate's or Sublicensee's, as applicable) average Net Sales price in such country or other jurisdiction during the period to which the Net Sales calculation applies for such Combination Product.", "": "" }, { "Text": "(iii) If AbbVie, its Affiliates, and Sublicensees do not separately sell in such country or other jurisdiction the Mono Product but do separately sell products containing as their sole active ingredients the other active ingredients contained in such Combination Product, the Net Sales attributable to such Combination Product shall be calculated by multiplying the Net Sales of such Combination Product by the fraction (D-E)/D where: \"D\" is the average Net Sales price during the period to which the Net Sales calculation applies for such Combination Product in such country or other jurisdiction and \"E\" is the average Net Sales price during the period to which the Net Sales calculation applies for products that contain as their sole active ingredients the other active ingredients in such Combination Product.", "": "" }, { "Text": "(iv) If AbbVie, its Affiliates, and Sublicensees do not separately sell in such country or other jurisdiction both the Mono Product and the other active ingredient or ingredients in such Combination Product, the Net Sales attributable to such Combination Product shall be calculated by multiplying the Net Sales of such Combination Product by the fraction 1/(1+F) where: \"F\" is the number of other active ingredients (other than a Licensed Compound) in such Combination Product. If the Parties cannot agree on such relative value, the Dispute shall be resolved pursuant to Section 13.7.", "": "" }, { "Text": "1.143 \"Neutral\" has the meaning set forth in Schedule 13.7.3.", "": "" }, { "Text": "1.144 \"New Indication\" means, with respect to a Licensed Product, an Indication that is not an Identified Indication for such Licensed Product.", "": "" }, { "Text": "1.145 \"Non-Breaching Party\" has the meaning set forth in Section 12.3.1.", "": "" }, { "Text": "1.146 \"Non-Vraylar Indication\" means (a) with respect to milestone payments triggered by events in the United States, an Indication for which cariprazine does not have Regulatory Approval for in the United States at the time the applicable regulatory milestone event is achieved pursuant to Section 6.2 and (b) with respect to the milestone payment for the First Commercial Sale in Japan, an Indication for which cariprazine does not have Regulatory Approval for in Japan at the time the applicable regulatory milestone event is achieved pursuant to Section 6.2.", "": "" }, { "Text": "1.147 \"Owned Patents\" has the meaning set forth in Section 10.2.3.", "": "" }, { "Text": "1.148 \"PAC Study\" or \"Post Authorization Commitment Study\" means any non-human study, human clinical trial, or other commitment with respect to a Licensed Compound or Licensed Product initiated after completion of a Phase III Study (including after receipt of Regulatory Approval) for such Licensed Product in a country or territory, the completion of which is recommended or required by the Regulatory Authority to obtain further information on such Licensed Product's safety or to measure the effectiveness of risk-management measures, including drug-drug interaction studies.", "": "" }, { "Text": "1.149 \"Party\" and \"Parties\" has the meaning set forth in the preamble hereto.", "": "" }, { "Text": "1.150 \"Party Development Activities\" means Development activities to be conducted by or on behalf of a Party pursuant to a Discovery Program Plan, IND-Enabling Study Plan and Budget, or Clinical Development Plan.", "": "" }, { "Text": "1.151 \"Patents\" means (a) all national, regional and international patents and patent applications, including provisional patent applications, (b) all patent applications filed either from such patents, patent applications or provisional applications or from an application claiming priority from either of these, including divisionals, continuations, continuations-in-part, provisionals, converted provisionals and continued prosecution applications, (c) any and all patents that have issued or in the future issue from the foregoing patent applications ((a) and (b)), including utility models, petty patents and design patents and certificates of invention, (d) any and all extensions or restorations by existing or future extension or restoration mechanisms, including revalidations, reissues, re-examinations and extensions (including any supplementary protection certificates and the like) of the foregoing patents or patent applications ((a), (b), and (c)), and (e) any similar rights, including so-called pipeline protection or any importation, revalidation, confirmation or introduction patent or registration patent or patent of additions to any of such foregoing patent applications and patents.", "": "" }, { "Text": "1.152 \"Payment\" has the meaning set forth in Section 6.8.", "": "" }, { "Text": "1.153 \"Person\" means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, unincorporated association, joint venture or other similar entity or organization, including a government or political subdivision, department or agency of a government.", "": "" }, { "Text": "1.154 \"Personal Data\" means (a) all information identifying, or in combination with other information, identifiable to an individual, including pseudonymized (key-coded) Clinical Data containing such information; and (b) any other information that is governed, regulated or protected by one or more Data Security and Privacy Laws.", "": "" }, { "Text": "1.155 \"Phase 0 Study\" means an exploratory, first-in-human trial conducted in accordance with the FDA 2006 Guidance on Exploratory Investigational New Drug Studies (or the equivalent in any country or other jurisdiction outside of the United States) and designed to expedite the development of therapeutic or imaging agents by establishing very early on whether the agent behaves in human subjects as was anticipated from pre-clinical studies.", "": "" }, { "Text": "1.156 \"Phase I Study\" means a human clinical trial of a Licensed Compound or Licensed Product, the principal purpose of which is a preliminary determination of safety, tolerability, pharmacological activity or pharmacokinetics in healthy individuals or patients or similar clinical study prescribed by the Regulatory Authorities, including the trials referred to in 21 C.F.R. §312.21(a), as amended.", "": "" }, { "Text": "1.157 \"Phase II Study\" means a human clinical trial of a Licensed Compound or Licensed Product, the principal purpose of which is a determination of safety and efficacy in the target patient population, which is prospectively designed to generate sufficient data that may permit commencement of pivotal clinical trials, or a similar clinical study prescribed by the Regulatory Authorities, from time to time, pursuant to Applicable Law or otherwise, including the trials referred to in 21 C.F.R. §312.21(b), as amended.", "": "" }, { "Text": "1.158 \"Phase IIa Study\" means a human clinical trial of a Licensed Compound or Licensed Product, as described in 21 CFR 312.21(b) (as hereafter modified or amended), whose primary objective is to explore safety and tolerability, pharmacokinetic and/or pharmacodynamics effects in selected populations of patients (including an equivalent clinical trial conducted in any country other than the United States). For clarity, a \"Phase IIa Study\" would include the Phase IIa Study portion of a Phase I/II human clinical trial involving a Licensed Compound or Licensed Product in which the Phase IIa portion of such clinical trial is continued to be conducted in patients with the disease being studied after the point in time at which more than a specified minimum number of human subjects (as described in the clinical trial protocol for such clinical trial) have been dosed in the portion of such clinical trial that constitutes a Phase I Study.", "": "" }, { "Text": "1.159 \"Phase IIb Study\" means a human clinical trial that utilizes the pharmacokinetic and/or pharmacodynamics information obtained from one or more previously conducted human clinical trial(s) and which is designed to provide a preliminary determination of efficacy of such Licensed Compound or Licensed Product in a target patient population over a range of doses or dose regimens, as further described in 21 CFR 312.21(b) (as hereafter modified or amended) (including an equivalent clinical trial conducted in any country other than the United States).", "": "" }, { "Text": "1.160 \"Phase III Study\" means a human clinical trial of a Licensed Compound or Licensed Product on a sufficient number of subjects in an indicated patient population that is designed to establish that a Licensed Compound or Licensed Product is safe and efficacious for its intended use and to determine the benefit/risk relationship, warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support marketing approval of such Licensed Compound or Licensed Product, including all tests and studies that are required by the FDA from time to time, pursuant to Applicable Law or otherwise, including the trials referred to in 21 C.F.R. §312.21(c), as amended.", "": "" }, { "Text": "1.161 \"Phase IV Study\" means any non-human study, human clinical trial, or other commitment with respect to a Licensed Compound or a Licensed Product with respect to any indication that is commenced after the receipt of Regulatory Approval for such indication or for a use that is the subject of an investigator-initiated study program, including the trials referred to in 21 C.F.R. § 312.85, as amended, but excluding any PAC Studies.", "": "" }, { "Text": "1.162 \"PMDA\" means Japan's Pharmaceuticals and Medical Devices Agency and any successor agency(ies) or authority having substantially the same function.", "": "" }, { "Text": "1.163 \"Pro-Metabolite Competing Product\" means any product that is or contains a compound, molecule or other therapeutic that generates desmethyl cariprazine or di-desmethyl cariprazine and related analogs including isotopic modifications, other than cariprazine as exploited pursuant to the Existing Collaboration Agreement.", "": "" }, { "Text": "1.164 \"Pro-metabolite Compound\" means (a) the compounds set forth on Schedule 1.164 together with any other compound capable of generating desmethyl cariprazine or di-desmethyl cariprazine that is Controlled by Richter or any of its Affiliates as of the Effective Date or at any time during the Discovery Program Term, and (b) any compounds identified by Richter during the Discovery Program Term under the Pro-metabolite Discovery Program that meet the Pro-metabolite Compound Criteria set forth in the Pro-metabolite Discovery Program Plan, and any metabolite, salt, ester, hydrate, solvate, isomer, enantiomer, free acid form, free base form, crystalline form, co-crystalline form, amorphous form, pro-drug (including ester pro-drug) form, racemate, polymorph, chelate, stereoisomer, tautomer, or optically active form of any of the foregoing.", "": "" }, { "Text": "1.165 \"Pro-metabolite Compound Criteria\" means the criteria agreed upon by the Parties for the compound, molecule or other therapeutic identified during the conduct of the Pro-metabolite Discovery Program, as set forth in the Pro-metabolite Discovery Program Plan.", "": "" }, { "Text": "1.166 \"Pro-metabolite Discovery Program\" means the program of discovery and pre-clinical activities for Pro-metabolites of desmethyl or di-desmethyl cariprazine undertaken as set forth in Section 3.1 and the Pro-metabolite Discovery Program Plan.", "": "" }, { "Text": "1.167 \"Pro-metabolite Discovery Program Plan\" means the written summary attached hereto as Schedule 1.167, including any amendments thereto, of the specific research activities to be conducted by Richter under the Pro-metabolite Discovery Program, the timelines for completion of such activities, and the corresponding Pro-metabolite Compound Criteria.", "": "" }, { "Text": "1.168 \"Pro-metabolite Product\" any product containing a Pro-metabolite Compound, alone or in combination with one (1) or more other active ingredients, in any and all forms, presentations, delivery systems, dosages, and formulations.", "": "" }, { "Text": "1.169 \"Processing\" (or its conjugates) means any operation or set of operations that is performed upon Personal Data, whether or not by automatic means, such as collection, recording, organization, storage, adaptation or alternation, retrieval, consultation, use, disclosure by transmission, dissemination or otherwise making available, alignment or combination, blocking, erasure or destruction.", "": "" }, { "Text": "1.170 \"Product Information\" has the meaning set forth in Section 9.1.", "": "" }, { "Text": "1.171 \"Product Infringement\" has the meaning set forth in Section 7.3.1(a).", "": "" }, { "Text": "1.172 \"Product Labeling\" means, with respect to a Licensed Product in a country or other jurisdiction in the Territory, (a) the Regulatory Authority-approved full prescribing information for such Licensed Product for such country or other jurisdiction, including any required patient information, and (b) all labels and other written, printed, or graphic matter upon a container, wrapper, or any package insert, instructions, websites, and other promotional materials utilized with or for such Licensed Product in such country or other jurisdiction.", "": "" }, { "Text": "1.173 \"Proposed Future In-Licensed Rights\" has the meaning set forth in Section 5.9.2(b).", "": "" }, { "Text": "1.174 \"Proposed Sublicense\" has the meaning set forth in Section 5.3.1.", "": "" }, { "Text": "1.175 \"Publication Policies\" has the meaning set forth in Section 9.6.", "": "" }, { "Text": "1.176 \"Quarterly Royalty Report\" has the meaning set forth in Section 6.5(a).", "": "" }, { "Text": "1.177 \"Regulatory Approval\" means, with respect to a country or other jurisdiction in the Territory, the approvals (including Drug Approval Applications), licenses, registrations, or authorizations of any Regulatory Authority necessary to Commercialize a Licensed Compound or Licensed Product in such country or other jurisdiction, including, where applicable, (a) pricing or reimbursement approval in such country or other jurisdiction, (b) pre- and post-approval marketing authorizations (including any prerequisite Manufacturing approval or authorization related thereto), and (c) approval of Product Labeling.", "": "" }, { "Text": "1.178 \"Regulatory Authority\" means any applicable supra-national, federal, national, regional, state, provincial, or local governmental or regulatory authority, agency, department, bureau, commission, council, or other entities (e.g., the FDA and PMDA) regulating or otherwise exercising authority with respect to activities contemplated in this Agreement, including the Exploitation of the Licensed Compounds or Licensed Products in the Territory.", "": "" }, { "Text": "1.179 \"Regulatory Data\" has the meaning set forth in Section 3.10.6.", "": "" }, { "Text": "1.180 \"Regulatory Documentation\" means all (a) applications (including all INDs and Drug Approval Applications and other regulatory filings), registrations, licenses, authorizations, and approvals (including Regulatory Approvals), (b) correspondence and reports submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority) and all supporting documents with respect thereto, including all regulatory drug lists, advertising and promotion documents, adverse event files, and complaint files, and (c) Clinical Data and data contained or relied upon in any of the foregoing, in each case ((a), (b), and (c)) relating to a Licensed Compound or Licensed Product.", "": "" }, { "Text": "1.181 \"Regulatory Exclusivity\" means, with respect to any country or other jurisdiction in the Territory, an additional market protection, other than Patent-related protection, granted by a Regulatory Authority in such country or other jurisdiction which confers an exclusive Commercialization period during which AbbVie or its Affiliates or Sublicensees have the exclusive right to market and sell (such that any Third Party is prevented from marketing and selling) a Licensed Compound or Licensed Product in such country or other jurisdiction through a regulatory exclusivity right.", "": "" }, { "Text": "1.182 \"Required Richter Territory Development Activities\" has the meaning set forth in Section 3.4.1.", "": "" }, { "Text": "1.183 \"Reverse Royalty Term\" means, with respect to each Licensed Product and each country or other jurisdiction in the Terminated Territory, the period beginning on the date of the first sale of such Licensed Product by Richter, its Affiliates or Sublicensees in such country or other jurisdiction after the effective date of the applicable termination (in whole or in part) of this Agreement with respect to such country or other jurisdiction and ending on the later to occur of (a) the expiration, invalidation or abandonment date of the last-to-expire AbbVie Patent or Joint Patent included in the AbbVie Grantback Technology that includes a Valid Claim that claims such Licensed Product in such country or other jurisdiction, (b) the expiration of Regulatory Exclusivity in such country or other jurisdiction for such Licensed Product and (c) the tenth (10th) anniversary of the first sale of such Licensed Product in such country or other jurisdiction after the effective date of the applicable termination (in whole or in part) of this Agreement with respect to such country or other jurisdiction. Solely for purposes of this Section 1.183, each reference in the definitions of \"Regulatory Exclusivity\" and \"Sublicensee\" to AbbVie shall be deemed to be a reference to Richter.", "": "" }, { "Text": "1.184 \"Reverted Country\" has the meaning set forth in Section 12.3.4.", "": "" }, { "Text": "1.185 \"Richter\" has the meaning set forth in the preamble hereto.", "": "" }, { "Text": "1.186 \"Richter Acquiree\" has the meaning set forth in Section 5.8.4.", "": "" }, { "Text": "1.187 \"Richter Acquirer\" has the meaning set forth in Section 5.8.3.", "": "" }, { "Text": "1.188 \"Richter Indemnitees\" has the meaning set forth in Section 11.1.", "": "" }, { "Text": "1.189 \"Richter Know-How\" means all Information that is (a) Controlled or Developed by Richter or any of its Affiliates as of the Effective Date or at any time during the Term, (b) not generally known and (c) reasonably necessary or useful for the Development, Manufacture, or Commercialization of a Licensed Compound or Licensed Product, but excluding any Joint Know-How or any Information disclosed in published Richter Patents or Joint Patents.", "": "" }, { "Text": "1.190 \"Richter Manufacturing Process\" has the meaning set forth in Section 4.9.3(a).", "": "" }, { "Text": "1.191 \"Richter Manufacturing Technology Transfer\" has the meaning set forth in Section 4.9.3(a).", "": "" }, { "Text": "1.192 \"Richter Patents\" means all of the Patents that are (a) Controlled or Developed by Richter or any of its Affiliates as of the Effective Date or at any time during the Term and (b) reasonably necessary or useful (or, with respect to patent applications, would be reasonably necessary or useful if such patent applications were to issue as patents) for the Development, Manufacture, or Commercialization of a Licensed Compound or Licensed Product, but excluding any Joint Patents. The Richter Patents include the Existing Patents.", "": "" }, { "Text": "1.193 \"Richter Product Trademarks\" means (a) the Trademark(s) to be owned and used by Richter or its Affiliates for the Development or Commercialization of Licensed Products in the Richter Territory and (b) any registrations thereof or any pending applications relating thereto in the Richter Territory (excluding, in any event, any trademarks, service marks, names or logos that include any corporate name or logo of the Parties or their Affiliates).", "": "" }, { "Text": "1.194 \"Richter Proprietary Manufacturing Information\" has the meaning set forth in Section 4.9.3(c).", "": "" }, { "Text": "1.195 \"Richter Prosecuted Infringements\" has the meaning set forth in Section 7.3.1(c).", "": "" }, { "Text": "1.196 \"Richter Supply Agreement\" has the meaning set forth in Section 4.9.1.", "": "" }, { "Text": "1.197 \"Richter Territory\" means the countries listed in Schedule 1.197.", "": "" }, { "Text": "1.198 \"Richter Territory Development Plan\" has the meaning set forth in Section 3.4.1.", "": "" }, { "Text": "1.199 \"ROFN Exercise Notice\" has the meaning set forth in Section 5.3.1.", "": "" }, { "Text": "1.200 \"Royalty Dispute\" has the meaning set forth in Schedule 12.9.1.", "": "" }, { "Text": "1.201 \"Royalty Term\" means, with respect to each Licensed Product and each country or other jurisdiction in the Territory, the period beginning on the date of the First Commercial Sale of such Licensed Product in such country or other jurisdiction, and ending on the later to occur of (a) the expiration, invalidation or abandonment date of the last Richter Patent or Joint Patent that includes one or more Valid Claims that (i) claim a Licensed Compound contained in such Licensed Product in such country or other jurisdiction or (ii) claim all Indications for which Regulatory Approval has been received for such Licensed Products in such country or other jurisdiction; (b) the expiration of Regulatory Exclusivity in such country or other jurisdiction for such Licensed Product; and (c) the tenth (10th) anniversary of the First Commercial Sale of such Licensed Product in such country or other jurisdiction.", "": "" }, { "Text": "1.202 \"Senior Officer\" means, with respect to Richter, its Chief Executive Officer or his/her designee, and with respect to AbbVie, its Chief Scientific Officer or his/her designee, with respect to Development matters and its Chief Commercial Officer or his/her designee, with respect to Commercialization matters.", "": "" }, { "Text": "1.203 \"SOFR\" means the Secured Overnight Financing Rate for a thirty (30)-day term published by US Federal Reserve Bank of New York, as adjusted from time to time on the first New York business day of each month.", "": "" }, { "Text": "1.204 \"Subcommittee\" has the meaning set forth in Section 2.1.2(r).", "": "" }, { "Text": "1.205 \"Sublicensee\" means a Person, other than an Affiliate or a Distributor, that is (a) with respect to AbbVie, granted a sublicense by AbbVie under the grants in Section 5.1 as provided in Section 5.3.1, excluding any Person to which AbbVie has granted such sublicense as a result of a settlement of a dispute involving any Richter Patents and (b) with respect to Richter, granted a sublicense by Richter under the grants in Section 5.2 as provided in Section 5.3.2.", "": "" }, { "Text": "1.206 \"Term\" has the meaning set forth in Section 12.2.", "": "" }, { "Text": "1.207 \"Terminated Discovery Program\" means each Discovery Program with respect to which this Agreement is terminated by AbbVie pursuant to Section 12.4.1. If this Agreement is terminated in its entirety, then both Discovery Programs will be considered Terminated Discovery Programs.", "": "" }, { "Text": "1.208 \"Terminated Product\" means each Licensed Product with respect to which this Agreement is terminated by Richter pursuant to Section 12.3.2 and each Licensed Product with respect to which this Agreement is terminated by AbbVie pursuant to Section 12.4.1. If this Agreement is terminated with respect to a Discovery Program, then all Licensed Products that are subject to such Discovery Program will be considered Terminated Products and if this Agreement is terminated in its entirety, then all Licensed Products will be considered Terminated Products.", "": "" }, { "Text": "1.209 \"Terminated Territory\" means (a) each country or jurisdiction with respect to which this Agreement is terminated by Richter pursuant to Section 12.3.2, (b) each country or jurisdiction with respect to which this Agreement is terminated by AbbVie pursuant to Section 12.4.1 and (c) each Reverted Country that is included in the Non-Breaching Party's territory pursuant to Section 12.3.4. If this Agreement is terminated in its entirety, then the entire Territory will be considered the Terminated Territory.", "": "" }, { "Text": "1.210 \"Territory\" means the entire world.", "": "" }, { "Text": "1.211 \"Third Party\" means any Person other than Richter, AbbVie and their respective Affiliates.", "": "" }, { "Text": "1.212 \"Third Party Claims\" has the meaning set forth in Section 11.1.", "": "" }, { "Text": "1.213 \"Third Party Payments\" has the meaning set forth in Section 6.4.2(b).", "": "" }, { "Text": "1.214 \"Third Party Provider\" has the meaning set forth in Section 3.7.", "": "" }, { "Text": "1.215 \"Trademark\" means any word, name, symbol, color, designation or device or any combination thereof that functions as a source identifier, including any trademark, trade dress, brand mark, service mark, trade name, brand name, logo, business symbol or domain names, whether or not registered.", "": "" }, { "Text": "1.216 \"Transferee Party\" has the meaning set forth in Section 4.9.3(c).", "": "" }, { "Text": "1.217 \"Transferor Party\" has the meaning set forth in Section 4.9.3(c).", "": "" }, { "Text": "1.218 \"Transition Agreement\" has the meaning set forth in Section 12.10.1.", "": "" }, { "Text": "1.219 \"United States\" or \"U.S.\" means the United States of America and its territories and possessions (including the District of Columbia and Puerto Rico).", "": "" }, { "Text": "1.220 \"Valid Claim\" means a claim of any issued and unexpired Patent whose validity, enforceability, or patentability has not been affected by any of the following: (a) irretrievable lapse, abandonment, revocation, cancellation, dedication to the public, or disclaimer; or (b) a holding, finding, or decision of invalidity, unenforceability, or non-patentability by a court, governmental agency, national or regional patent office, or other appropriate body that has competent jurisdiction, such holding, finding, or decision being final and unappealable or unappealed within the time allowed for appeal. For clarity, a holding, finding or decision that is final and unappealable or unappealed means a holding, finding or decision from which no appeal (other than a petition to the United States Supreme Court for a writ of certiorari or a similar appeal the consideration of which is subject to the discretion of the higher court) can be or has been taken.", "": "" }, { "Text": "1.221 \"Valuation Expert\" has the meaning set forth in Schedule 12.9.1.", "": "" }, { "Text": "1.222 \"Valuation Notice\" has the meaning set forth in Schedule 12.9.1.", "": "" }, { "Text": "1.223 \"Voting Stock\" has the meaning set forth in the definition of \"Change in Control.", "": "" }, { "Text": "1.224 \"Vraylar Indication\" means (a) with respect to milestone payments triggered by events in the United States, an Indication for which cariprazine has Regulatory Approval for in the United States at the time the applicable regulatory milestone event is achieved pursuant to Section 6.2 and (b) with respect to the milestone payment for the First Commercial Sale in Japan, an Indication for which cariprazine has Regulatory Approval for in Japan at the time the applicable regulatory milestone event is achieved pursuant to Section 6.2.", "": "" }, { "Text": "1.225 \"Withholding Amount\" has the meaning set forth in Section 6.8.", "": "" }, { "Text": "1.226 \"Withholding Party\" has the meaning set forth in Section 6.8.", "": "" }, { "Text": "1.227 \"Working Group\" has the meaning set forth in Section 2.5.", "": "" }, { "Text": "-5-", "": "" }, { "Text": "Schedule 1.59", "": "" }, { "Text": "D3 Receptor Discovery Program Plan", "": "" }, { "Text": "Program Overview and Objectives", "": "" }, { "Text": "There is a growing body of evidence, including clinical observations with Vraylar® that suggest the dopamine D3 receptor (D3R) plays a critical role in several brain disorders. To date, however, there has been a lack of highly selective D3R compounds that can be used to explore the significance of D3R signaling and the consequences of modulating receptor function in clinical and non-clinical settings. Consequently, targeting the D3R has emerged as a potential treatment of major neurological disorders such as Schizophrenia, Bipolar Disorder, Major Depressive Disorder, Parkinson's Disease (PD), Attention Deficit Hyperactivity Disorder, Autism Spectrum disorder and Substance Use Disorder (addiction). Recent preclinical studies also implicate D3R antagonism in the treatment of Post-Traumatic Stress Disorder (PTSD).", "": "" }, { "Text": "The aim of this program is to identify and develop CNS-penetrant dopamine D3R selective compounds that can be used to clinically test the role of D3R in neuropsychiatric diseases. Using novel medicinal chemistry approaches, i.e., computational docking and free energy perturbation analysis as well as the crystal structures of the D3 and D2Rs, the goal is to identify new chemical structures that are highly selective for the D3R, as compared with compounds that emerged from traditional drug discovery approaches.", "": "" }, { "Text": "Status", "": "" }, { "Text": "The initial chemical strategy for this program relied on the literature of D3 receptor ligands, experience from previous in-house D3 receptor programs and a pharmacophore model. Approximately 400 compounds (listed in Schedule 1.56) have thus far been synthesized based on this 'modular' approach (i.e., combination of head, linker and tail moieties considering the structure of dopamine D2 and D3 receptor modulators, including that of cariprazine). Moreover, the use of 3D computer modeling has identified two important protein-ligand interactions that differ between the D3 and D2Rs which may contribute to compound selectivity. Using this approach, early work identified a spiro-indolinone head group that was both novel and had enhanced receptor selectivity. When this head group was combined with various linker and tail groups, the antagonist 70022302 was identified, a compound that is ~100-fold selective for the human D3R vs D2R and has low affinity for 5-HT1A and 5-HT2B receptors as well as other receptors of interest. Subsequent lead optimization/ SAR studies identified 70024303 a highly selective D3R antagonist with a unique pharmacological and / or physiological profile.", "": "" }, { "Text": "Further optimization of 70022302 is focused on selection of analogues with improved brain to plasma (B/P) ratio while maintaining or exceeding in vitro hD3R binding affinity, functional potency and selectivity vs hD2R and other targets. Compound 70024303 emerged as one the promising compounds in the spiro-indolinone series that meets all these criteria. Further characterization of 70024303 along with synthesis of new compounds is ongoing.", "": "" }, { "Text": "In addition to these activities, efforts to identify D3R partial agonists have progressed based on the use of dichlorophenylpiperazine and other head groups that appear to have partial agonistic attributes. The screening of novel head groups suitable for further derivatization towards the synthesis of partial agonists is in progress, using the modular approach and computational methods described above to predict D3R affinity.", "": "" }, { "Text": "The Discovery Program Plan to identify D3 Receptor Compounds comprises the following key activities:", "": "" }, { "Text": "1. Compound screening and evaluation", "": "" }, { "Text": "2. Preclinical characterization of compounds", "": "" }, { "Text": "3. Selection and characterization of Lead Compounds and Backup compounds for candidate nomination", "": "" }, { "Text": "4. IND enabling studies", "": "" }, { "Text": "The studies conducted to support this D3 Receptor Discovery Program Plan will be conducted, with AbbVie's prior written consent (not to be unreasonably withheld, delayed or conditioned), at mutually-agreed-upon vendors, service provides, CROs or CMOs. Gedeon Richter will be responsible for managing day-to-day project management with contracted service providers in accordance with the terms and conditions of the Agreement.", "": "" }, { "Text": "Screening & Identification", "": "" }, { "Text": "Gedeon Richter Activities and Deliverables", "": "" }, { "Text": "Preclinical Characterization of D3R Modulators", "": "" }, { "Text": "Gedeon Richter Activities and Deliverables", "": "" }, { "Text": "AbbVie Activities", "": "" }, { "Text": "Estimated Time- lines", "": "" }, { "Text": "Selection & Characterization of Lead Compounds for Candidate Nomination", "": "" }, { "Text": "Gedeon Richter Activities and Deliverables", "": "" }, { "Text": "AbbVie Activities", "": "" }, { "Text": "Estimated Timelines", "": "" }, { "Text": "Discovery and preclinical activities described above are expected to yield compounds that satisfy the following Lead Compound Criteria", "": "" }, { "Text": "Table I. Lead Compound Criteria", "": "" }, { "Text": "Category", "": "" }, { "Text": "In-vitro Pharmacology", "": "" }, { "Text": "In-vivo Pharmacology", "": "" }, { "Text": "Target tissue (brain) penetration", "": "" }, { "Text": "Preclinical Safety / Safety Pharmacology", "": "" }, { "Text": "CMC / DS", "": "" }, { "Text": "IND-Enabling Studies Plan and Budget", "": "" }, { "Text": "Phase 1 enabling studies", "": "" }, { "Text": "Gedeon Richter Activities and Deliverables", "": "" }, { "Text": "AbbVie Activities", "": "" }, { "Text": "Estimated Timelines", "": "" }, { "Text": "IND-Enabling Studies Criteria (for development candidate): The IND Enabling Studies Plan and Budget is expected to generate data sets to determine whether a Lead Compound should further progress to clinical studies as a development candidate.", "": "" }, { "Text": "The overall goal of the IND-Enabling Studies Plan and Budget with the Lead Compound is to develop a data package that meets the general criteria outlined below and acceptable to regulatory authorities to authorize initiation of first-in-human (FIH) clinical studies.", "": "" }, { "Text": "IND-Enabling Studies (Development Candidate): General Criteria", "": "" }, { "Text": "Category", "": "" }, { "Text": "In-vitro Pharmacology", "": "" }, { "Text": "In-vivo Pharmacology", "": "" }, { "Text": "Target tissue (brain) penetration", "": "" }, { "Text": "Preclinical Safety / Secondary Pharmacology", "": "" }, { "Text": "PK-ADME", "": "" }, { "Text": "GLP toxicology Studies", "": "" }, { "Text": "API", "": "" }, { "Text": "IP", "": "" }, { "Text": "Budget for the IND-Enabling Activities", "": "" }, { "Text": "Activities", "": "" }, { "Text": "Preclinical characterization", "": "" }, { "Text": "", "": "" }, { "Text": "IND enabling preclinical GLP studies", "": "" }, { "Text": "", "": "" }, { "Text": "Materials for Pre IND meeting(s) / IND ready documents", "": "" }, { "Text": "* 1 employee working full day (8h / day) in the given period; ** including but not limited to: study monitoring activity, TK method development and TK measurements, data evaluation, reporting", "": "" }, { "Text": "Figure 1.", "": "" }, { "Text": "Current Status for Preclinical Activities with D3 Compound – 70024303", "": "" }, { "Text": "Schedule 1.106", "": "" }, { "Text": "Identified Indications", "": "" }, { "Text": "• Bipolar Mania / Mixed", "": "" }, { "Text": "• Bipolar Depression", "": "" }, { "Text": "• Major Depressive Disorder (Adjunct or Monotherapy)", "": "" }, { "Text": "• Autism Spectrum Disorder (irritability, core symptoms)", "": "" }, { "Text": "• Agitation or Psychosis associated with Alzheimer's Disease, Parkinson's Disease, or Frontotemporal Dementia", "": "" }, { "Text": "• General Anxiety Disorder (Adjunct or Monotherapy)", "": "" }, { "Text": "• Posttraumatic stress disorder", "": "" }, { "Text": "• Schizophrenia Negative Symptoms; Cognitive Impairment Associated with Schizophrenia", "": "" }, { "Text": "• Cognitive impairment associated with MDD, Bipolar Disorder, Alzheimer's Disease or Parkinson's Disease", "": "" }, { "Text": "• Obsessive Compulsive Disorder", "": "" }, { "Text": "• Attention deficit hyperactivity disorder", "": "" }, { "Text": "Schedule 1.134", "": "" }, { "Text": "Manufacturing Costs", "": "" }, { "Text": "For purposes of the Agreement, \"Manufacturing Costs\" means:", "": "" }, { "Text": "(a) with respect to a Licensed Compound Manufactured by Richter, Richter's internal and external costs, calculated by Richter in a manner that is consistent with the Accounting Standards used by Richter to determine the manufacturing cost (direct manufacturing and manufacturing support costs) of other compounds manufactured by Richter at its facilities, incurred in manufacturing, acquiring, packaging, transporting or storing such Licensed Compound (including the costs of direct materials, direct labour, factory overhead, quality control and quality assurance costs, regulatory compliance and other support costs in relation to Manufacturing), in each case, to the extent directly related and allocable to the Licensed Compound supplied to AbbVie hereunder. Manufacturing Costs shall not include any underutilized capacity at any manufacturing site or facility where the Licensed Compound is Manufactured or any cost attributable to general corporate activities, including, by way of example, executive management, investor relations, business development, legal affairs and finance; and", "": "" }, { "Text": "(b) with respect to Licensed Product Manufactured by AbbVie, AbbVie's internal and external costs, calculated by AbbVie in a manner that is consistent with the Accounting Standards used by AbbVie to determine the manufacturing cost (direct manufacturing and manufacturing support costs) of other products manufactured by AbbVie at its facilities, incurred in manufacturing, acquiring, packaging, transporting or storing such Licensed Product (including the costs of direct materials, direct labour, factory overhead, quality control and quality assurance costs, regulatory compliance and other support costs in relation to Manufacturing), in each case, to the extent directly related and allocable to the Licensed Product supplied to Richter hereunder. Manufacturing Costs shall not include any underutilized capacity at any manufacturing site or facility where the Licensed Product is Manufactured or any cost attributable to general corporate activities, including, by way of example, executive management, investor relations, business development, legal affairs and finance.", "": "" }, { "Text": "Schedule 1.167", "": "" }, { "Text": "Pro-metabolite Discovery Program Plan", "": "" }, { "Text": "Program Overview and Objectives", "": "" }, { "Text": "Cariprazine (Vraylar®), a D3R preferring compound, is thought to confer a distinct and unique clinical profile vs. other atypical antipsychotic agents. In particular, the higher D3R vs. D2R occupancy seen at lower doses (≤ 3 mg/d) may underlie clinical efficacy in unipolar depression, both poles of bipolar disorder, negative symptoms of schizophrenia, anxiety and improvements of cognitive tasks. These benefits are not typically seen at higher doses where the preferential binding to D3R is lost or there may be excessive D2R antagonism interfering with D3R effects. Since cariprazine's active metabolites (desmethyl-cariprazine, DCAR and didesmethyl-cariprazine, DDCAR) have a relatively higher D3R/D2R selectivity, the goal of the Pro-metabolite Discovery Program is to develop compounds that are directly converted to DCAR or DDCAR without the formation of cariprazine.", "": "" }, { "Text": "The goal of the Pro-metabolite Discovery Program is to identify molecules that are rapidly converted in vivo to DCAR and/or DDCAR. Pro-metabolite compounds are expected to satisfy the criteria outlined below:", "": "" }, { "Text": "Prometabolite Compound Criteria:", "": "" }, { "Text": "• In vitro dopamine D3/D2 receptor binding, with D3 preference for the pro-drug • Rapid in vivo bioconversion to DCAR and / or DDCAR, with little to no detectable cariprazine • Acceptable brain exposure of DCAR and/or DDCAR to achieve efficacy in relevant preclinical models within the range of that observed with cariprazine after oral dosing • The bioconversion to DCAR and/or DDCAR should be species independent • Total brain and plasma exposure (DCAR and/or DDCAR) should be similar to or higher than dosing with equimolar cariprazine. • Dose-independent conversion in wide dose range • Safety/ tolerability profile should be equivalent to or better than cariprazine.", "": "" }, { "Text": "Program Status", "": "" }, { "Text": "To date, this program has generated several chemical analogues (listed in Schedule 1.164) that are rapidly converted to DCAR and/or DDCAR after oral administration, without significant transformation to cariprazine. These chemical analogues include leads from the hemiaminal-ether, dipeptide, cyclic carbamide and sulfenamide series (see Figure 1). Compounds from these series were screened via in vitro and in vivo models to determine their D3R/D2R selectivity and metabolic profile. From the set of analogs thus far synthesized, 70023351 (also known as RGH-932), a hemiaminal-ether DCAR derivative has emerged as a promising compound that is being further characterized and advanced as the current Lead. In addition, two compounds, RGH-289 and RGH-556 are being evaluated as potential back-up compounds (see Figure 2).", "": "" }, { "Text": "Studies have shown that RGH-932 preferentially binds to the D3R versus D2R, is stable at neutral pH, readily converts to DCAR at acidic pH and is subsequently metabolized to DDCAR. Pharmacokinetic investigations in rats (po, iv, ip, or sc), dogs (po) and rhesus monkeys (po) have revealed that both DCAR and DDCAR were present in blood after dosing with RGH-932, while little to no transformation of RGH-932 to cariprazine has been detected, based on initial evaluation. Behavioral studies in rodents, have also shown efficacy in rodent models of acute psychosis after dosing with RGH-932. Additional characterization including behavioral, toxicology and cardiovascular studies are ongoing.", "": "" }, { "Text": "Due to the low number of functional groups, only two sites appear to be available for chemical modification; the urea site which can be modified in several ways at both the nitrogen and oxygen atom and the more nucleophilic tertiary alkyl N-atom of the piperazine which can also be quaternarized. Thus far, several additional chemical analogues have been identified, including 70023586 and 70023604 from the hemiaminal-ether series, 70024113 and 70024948 from the sulfonamide series, 70023182 from the peptide series and 70023528 from the cyclic carbamide series. These compounds will be characterized by additional preclinical activities described in this Research Program Plan as potential back-up compounds.", "": "" }, { "Text": "The research plan for the Pro-metabolite Discovery Program comprises the following key activities:", "": "" }, { "Text": "1. Compound screening and evaluation", "": "" }, { "Text": "2. Preclinical characterization of selected compounds", "": "" }, { "Text": "3. Selection and characterization of Lead Compound and Backup compound for Candidate Nomination", "": "" }, { "Text": "4. IND enabling studies", "": "" }, { "Text": "Studies conducted to support this Pro-metabolite Discovery Program will be conducted at Gedeon Richter labs or with AbbVie's prior written consent (not to be reasonably withheld, delayed or conditioned) at mutually-agreed-upon vendors, service providers, CROs or CMOs. Gedeon Richter will be responsible for managing day-to-day project management with contracted service providers in accordance with the terms and conditions of the Agreement.", "": "" }, { "Text": "Compound Screening and Evaluation", "": "" }, { "Text": "Gedeon Richter Activities and Deliverables", "": "" }, { "Text": "Preclinical Characterization of Selected Compounds", "": "" }, { "Text": "", "": "" }, { "Text": "Estimated Timelines", "": "" }, { "Text": "AbbVie Activities", "": "" }, { "Text": "At the conclusion of the above activities, the team should have identified promising candidate compound(s) for advancement to GLP toxicology and other IND enabling studies.", "": "" }, { "Text": "Discovery and preclinical activities described above are expected to yield compounds that satisfy the following Lead Compound Criteria", "": "" }, { "Text": "Pro-Metabolite Lead Compound Criteria:", "": "" }, { "Text": "Category", "": "" }, { "Text": "In-vitro Pharmacology", "": "" }, { "Text": "In-vivo Pharmacology", "": "" }, { "Text": "Target tissue (brain) Exposure", "": "" }, { "Text": "Preclinical Safety / Safety Pharmacology", "": "" }, { "Text": "CMC / API", "": "" }, { "Text": "IND Enabling Studies Plan & Budget", "": "" }, { "Text": "Phase 1 Enabling", "": "" }, { "Text": "Gedeon Richter Activities and Deliverables", "": "" }, { "Text": "AbbVie Activities", "": "" }, { "Text": "Estimated Timelines", "": "" }, { "Text": "IND-Enabling Studies Criteria (for development candidate): The IND Enabling Studies Plan and Budget is expected to generate data sets to determine whether a Lead Compound should further progress to clinical studies.", "": "" }, { "Text": "The overall goal of the IND-Enabling Studies Plan and Budget with the Lead Compound is to develop a data package that meets the general criteria outlined below and acceptable to regulatory authorities to authorize initiation of first-in-human (FIH) clinical studies.", "": "" }, { "Text": "IND-Enabling Studies (for development candidate): General Criteria", "": "" }, { "Text": "Category", "": "" }, { "Text": "In-vitro Pharmacology", "": "" }, { "Text": "In-vivo Pharmacology", "": "" }, { "Text": "Preclinical Safety / Secondary Pharmacology", "": "" }, { "Text": "Target tissue (brain) exposure", "": "" }, { "Text": "PK-ADME", "": "" }, { "Text": "GLP toxicology studies", "": "" }, { "Text": "API", "": "" }, { "Text": "IP", "": "" }, { "Text": "Estimated Budget for the IND-Enabling Activities for RGH-932 (Richter internal & CRO)", "": "" }, { "Text": "Activities", "": "" }, { "Text": "IND enabling preclinical studies", "": "" }, { "Text": "", "": "" }, { "Text": "Materials for Pre IND meeting(s) / IND ready documents", "": "" }, { "Text": "13w GLP Tox and reprotox", "": "" }, { "Text": "", "": "" }, { "Text": "Chronic Tox, Carcinogenicity", "": "" }, { "Text": "", "": "" }, { "Text": "* including but not limited to: study monitoring activity, TK method development and TK measurements, data evaluation, reporting etc. ** = 1 employee working full day (8h / day) in the given period", "": "" }, { "Text": "Estimated Budget for the IND-Enabling Activities for RGH-932 back-up compounds", "": "" }, { "Text": "Activities", "": "" }, { "Text": "IND enabling preclinical studies", "": "" }, { "Text": "", "": "" }, { "Text": "* including but not limited to: study monitoring activity, TK method development and TK measurements, data evaluation, reporting etc. ** = 1 employee working full day (8h / day) in the given period", "": "" }, { "Text": "Figure 2: Structures of RGH-932", "": "" }, { "Text": "(and potential back-up compounds RGH-289 and RGH-556)", "": "" }, { "Text": "RGH-932 (70023351)", "": "" }, { "Text": "RGH-289 (70023528)", "": "" }, { "Text": "RGH-556 (70024948)", "": "" }, { "Text": "Schedule 1.197", "": "" }, { "Text": "Richter Territory", "": "" }, { "Text": "• Albania", "": "" }, { "Text": "• Andorra", "": "" }, { "Text": "• Armenia", "": "" }, { "Text": "• Austria", "": "" }, { "Text": "• Azerbaijan", "": "" }, { "Text": "• Belarus", "": "" }, { "Text": "• Belgium", "": "" }, { "Text": "• Bosnia and Herzegovina", "": "" }, { "Text": "• Bulgaria", "": "" }, { "Text": "• Croatia", "": "" }, { "Text": "• Cyprus", "": "" }, { "Text": "• Czechia", "": "" }, { "Text": "• Denmark", "": "" }, { "Text": "• Estonia", "": "" }, { "Text": "• Finland", "": "" }, { "Text": "• France", "": "" }, { "Text": "• Georgia", "": "" }, { "Text": "• Germany", "": "" }, { "Text": "• Greece", "": "" }, { "Text": "• Hungary", "": "" }, { "Text": "• Iceland", "": "" }, { "Text": "• Ireland", "": "" }, { "Text": "• Italy", "": "" }, { "Text": "• Kazakhstan", "": "" }, { "Text": "• Kyrgyzstan", "": "" }, { "Text": "• Latvia", "": "" }, { "Text": "• Lithuania", "": "" }, { "Text": "• Luxembourg", "": "" }, { "Text": "• Malta", "": "" }, { "Text": "• Monaco", "": "" }, { "Text": "• Montenegro", "": "" }, { "Text": "• Netherlands", "": "" }, { "Text": "• North Macedonia", "": "" }, { "Text": "• Norway", "": "" }, { "Text": "• Poland", "": "" }, { "Text": "• Portugal", "": "" }, { "Text": "• Republic of Moldova", "": "" }, { "Text": "• Romania", "": "" }, { "Text": "• Russian Federation", "": "" }, { "Text": "• San Marino", "": "" }, { "Text": "• Serbia", "": "" }, { "Text": "• Slovakia", "": "" }, { "Text": "• Slovenia", "": "" }, { "Text": "• Spain", "": "" }, { "Text": "• Sweden", "": "" }, { "Text": "• Switzerland", "": "" }, { "Text": "• Tajikistan", "": "" }, { "Text": "• Turkmenistan", "": "" }, { "Text": "• Ukraine", "": "" }, { "Text": "• United Kingdom of Great Britain and Northern Ireland", "": "" }, { "Text": "• Uzbekistan", "": "" }, { "Text": "• Vietnam", "": "" }, { "Text": "-39-", "": "" }, { "Text": "99450416_50", "": "" }, { "Text": "Schedule 3.6.1", "": "" }, { "Text": "Draft Development Manufacturing Plan", "": "" }, { "Text": "GENERAL CONSIDERATIONS This draft document is a general guide to the Development Manufacturing Plan – for both IND API Development & API supply and for Late-Stage API Development & API Supply. Specifics will be finalized by JSC during the collaboration phase depending on the profile of Lead Compound and Back-up Compound(s) that will be progressed.", "": "" }, { "Text": "Should there be a need to support activities by Gedeon Richter, AbbVie will provide relevant drug product regulatory submission documents, as appropriate.", "": "" }, { "Text": "IND API Development & API Supply AbbVie will provide guidance and technical / scientific input for the API Development activities as part of the Joint Steering Committee (JSC) and associated working team meetings. As part of the collaboration, there will be designated individuals for API and API supply-related support from AbbVie. Outlined below are the major API activities and deliverables to enable IND submission.", "": "" }, { "Text": "This IND-Enabling Studies Plan and Budget (INDPB) summarizes the anticipated IND-enabling studies that will be conducted once the JSC nominates a Lead Compound (LC). The goal of the INDBP will be to robustly characterize the safety profile of the nominated LC in accordance with the regulatory guidelines provided by FDA, with the goal of filing an IND application following completion of the studies.", "": "" }, { "Text": "This document is meant to serve as a high-level guideline of standard IND-enabling studies. The actual studies run once a LC is nominated will be agreed upon by the JSC, with AbbVie providing input on strategic study decisions, study protocol review and study report review. For clarity, initial drug substance and tox formulation work are to be conducted by Gedeon Richter whereas clinical formulation and drug product analytical development are to be conducted by AbbVie.", "": "" }, { "Text": "The first step to conducting IND enabling studies is the robust characterization of the LC including solubility (salt, polymorph, etc.) screening, process familiarization, analytical method development. Following initial studies, it is expected that batches of both non-GMP and GMP will be produced and characterized.", "": "" }, { "Text": "At the initiation of IND enabling studies, it is expected that Gedeon Richter will manufacture a suitable quantity (~50g) of non-GMP API for use in salt and polymorph screening, tox formulation and analytical development. [Given that some of the analytical method development may already be in progress, it is expected that Gedeon Richter will share with AbbVie any results generated to characterize the identity, structure, purity, solid form, water/solvent content, etc.]. Salt/polymorph screening and formulation development will commence immediately, with the goal of determining the manner in which the API will be dosed in the toxicology and safety pharmacology studies, and also in future human trials. The required exact material quantity and the detailed manufacturing project schedule for each of the INDBP will be provided to meet project needs and timelines.", "": "" }, { "Text": "Coincident with the above, it is expected that Gedeon Richter will initiate a process development effort for larger-scale synthesis of the chosen API, and a non-GMP demonstration batch of sufficient quantity to support GLP tox and formulation/process development studies. The non-GMP batch will be analyzed for impurities and various physiochemical characterizations will be conducted. It is expected that compound stability will be evaluated on samples from the non-GMP batch over time periods ranging from 1 month to 6 months at temperatures ranging from 5°C to 40°C. As deemed necessary by GR for preclinical studies, a suitable amount of stable label (SLIS) of the API will also be prepared.", "": "" }, { "Text": "At a time determined by the JSC, Gedeon Richter will initiate production of a cGMP batch of sufficient quantity to support early-phase clinical studies, and the resulting API will be formulated into a first-in-human study ready drug product by AbbVie. A second stability study will be initiated on the cGMP API with timepoints extending out to 24 months.", "": "" }, { "Text": "In summary, API synthesis, formulation to support GLP toxicology / other IND enabling studies and preliminary pharmaceutics studies for the LC will be conducted by Gedeon Richter.", "": "" }, { "Text": "API", "": "" }, { "Text": "• API manufacturing including procurement of raw materials • API process development activities • Conduct polymorphic and salt screening to discover solid-state landscape and to choose optimal solid form for development • Long term and accelerated ICH stability studies for drug substance in solid-state • Conduct physicochemical properties evaluation including calculated and experimental observations for molecular weight, Log P and pKa", "": "" }, { "Text": "Analytical: Development of phase-appropriate analytical methods and validation", "": "" }, { "Text": "GLP/Tox Formulation Development: Develop and manufacture a suitable GLP tox formulation and conduct supportive analytical testing", "": "" }, { "Text": "Reports: Prepare required reports and documents to support Pre-IND Meeting and submission of IND", "": "" }, { "Text": "API IND Reports Reports anticipated to be required by AbbVie for an IND include but are not limited to the following documents.", "": "" }, { "Text": "● Properties of the API: optical isomerism, physical state/description, melting point, pKa, solubility (specify conditions - temp./pH), hygroscopicity, polymorphism", "": "" }, { "Text": "● Names and addresses of sites performing API manufacture and testing (release and stability)", "": "" }, { "Text": "● API batch records which should include any testing done in-process and at intermediates and a summary of deviations/non-conformances", "": "" }, { "Text": "● ChemDraw (or suitable equivalent) file of synthetic scheme for GMP steps", "": "" }, { "Text": "● Any reports or batch records for manufacture of starting materials and CoAs for the starting materials (these are informational only)", "": "" }, { "Text": "● Documentation on how the GLP tox batch was manufactured (e.g., synthetic scheme or development report) so that a high-level comparison can be made with the GMP batch", "": "" }, { "Text": "● Confirmation of structure: information associated with mass spec, IR, NMR (H1 and C13), X-ray, UV (including spectra)", "": "" }, { "Text": "● PMI assessment reports; summaries of control strategies for class 1-2 impurities from starting materials and GMP synthesis steps; Option 4 control strategies for Class 1-2 impurities; structures of any identified drug substance impurities if different from those specified in the drug substance", "": "" }, { "Text": "● Validation information - acceptance criteria, results, chromatogram overlays, linearity plots", "": "" }, { "Text": "● CoAs / results for clinical and non-clinical lots; BSE/TSE and cGMP statements should also be available for clinical material as required for regulatory shipment or other purposes.", "": "" }, { "Text": "● Batch specifications, along with justification for each specification", "": "" }, { "Text": "● Reference standard CoA or summary of results", "": "" }, { "Text": "● If details are not provided in the batch records, documentation describing all components of the API package", "": "" }, { "Text": "● Stability protocol(s) and details of study (e.g. packaging used for stability samples); stability data", "": "" }, { "Text": "Late-Stage API Development & API Supply It is expected that Gedeon Richter will continue API development of a larger-scale process suitable for late-phase clinical supplies and intended commercialization and provide support of ongoing and initiation of future clinical studies by manufacturing GMP API in support of Phase 1b and Phase 2 Trials. It is expected that Gedeon Richter will also manufacture GMP DS for Phase 3 Trial and long-term ICH compliant DS stability. Outlined below are the potential high-level API activities and deliverables to support late-stage clinical and NDA submission.", "": "" }, { "Text": "• Deliveries o API for Ph 1b, 2 and 3 clinical studies and carcinogenicity studies (using the proposed commercial process) o Others as needed – API reference standard, impurity (enantiomer, regio-isomers, etc.) standards, stable labeled API, radiolabeled API • API process development o Commercial route assessment – assess current route for scale-up/commercial liabilities (COGs, challenging reaction conditions, persistent impurities (including potential mutagenic impurities) o Evaluation of alternate routes to address liabilities o Demonstration of the chosen route on an appropriate scale o Regulatory starting material assessment of the chosen commercial route (AbbVie has an RSM committee and will provide guidance) o Mutagenic impurity assessment and control strategy for the chosen commercial route (AbbVie has an MI committee and will provide guidance) • Polymorph screen of the API and isolated intermediates (AbbVie has a tiered approach to this activity and will provide guidance) • Salt screen (if beneficial to commercial formulation) • Other solid-state studies of the API, including a thorough assessment of API isomerization risk • EHS assessment – OEL/EEL assessment, handling/containment requirements (AbbVie Drug Handling Committee will provide guidance) • Selection of appropriate packaging for API • Commercial supplier selection for regulatory starting materials, intermediates, API (AbbVie has an established process, including preferred suppliers, and will provide guidance) • Development and stage-appropriate validation of analytical methods • Development and justification of specifications/acceptance criteria • Release testing of API batches • ICH stability on API batches • R&D stability on regulatory starting materials and isolated intermediates • Stress degradation studies on API", "": "" }, { "Text": "-43-", "": "" }, { "Text": "99450416_50", "": "" }, { "Text": "Schedule 3.9.5", "": "" }, { "Text": "FTE Rates", "": "" }, { "Text": "With respect to activities performed under this Agreement in the United States, the FTE Rate shall be $375,000 per one full FTE per full 12-month Calendar Year, which rate includes all direct and indirect costs of the performing Party's FTE, including personnel and travel expenses. Such rate is subject to adjustment pursuant to Section 3.9.5.", "": "" }, { "Text": "With respect to activities performed under this Agreement outside the United States, the FTE Rate shall be $255,000 per one full FTE per full 12-month Calendar Year, which rate includes all direct and indirect costs of the performing Party's FTE, including personnel and travel expenses. Such rate is subject to adjustment pursuant to Section 3.9.5.", "": "" }, { "Text": "-44-", "": "" }, { "Text": "99450416_50", "": "" }, { "Text": "Schedule 4.9.1(a)", "": "" }, { "Text": "Principal Terms of Richter Supply Agreement", "": "" }, { "Text": "1. Purpose and Scope of the Supply Agreement", "": "" }, { "Text": "2. Purchase Price", "": "" }, { "Text": "3. Delivery Terms", "": "" }, { "Text": "4. Payment Terms", "": "" }, { "Text": "5. Supply Terms", "": "" }, { "Text": "6. Quality Agreement", "": "" }, { "Text": "7. Representations and Warranties", "": "" }, { "Text": "8. Indemnification", "": "" }, { "Text": "9. Term and Termination", "": "" }, { "Text": "10. Assignment", "": "" }, { "Text": "11. Choice of Law and Dispute Resolution", "": "" }, { "Text": "12. Additional Terms", "": "" }, { "Text": "-48-", "": "" }, { "Text": "99450416_50", "": "" }, { "Text": "Schedule 4.9.2(a)", "": "" }, { "Text": "Principal Terms of AbbVie Supply Agreement", "": "" }, { "Text": "1 Purpose and Scope of the Supply Agreement", "": "" }, { "Text": "2. Purchase Price", "": "" }, { "Text": "3. Delivery Terms", "": "" }, { "Text": "4. Payment Terms", "": "" }, { "Text": "5. Supply Terms", "": "" }, { "Text": "6. Quality Agreement", "": "" }, { "Text": "7. Representations and Warranties", "": "" }, { "Text": "8. Indemnification", "": "" }, { "Text": "9. Term and Termination", "": "" }, { "Text": "10. Assignment", "": "" }, { "Text": "11. Choice of Law and Dispute Resolution", "": "" }, { "Text": "12. Additional Terms", "": "" }, { "Text": "-52-", "": "" }, { "Text": "99450416_50", "": "" }, { "Text": "Schedule 9.5", "": "" }, { "Text": "Form of Press Release", "": "" }, { "Text": "PRESS RELEASE AbbVie and Gedeon Richter Announce Collaboration in Neuropsychiatric Diseases", "": "" }, { "Text": "– Companies will research, develop and commercialize novel dopamine receptor modulators for potential treatment of neuropsychiatric conditions – Agreement builds on 15 years of successful collaboration between AbbVie and Richter, including globally launched cariprazine products (VRAYLAR® / REAGILA®)", "": "" }, { "Text": "NORTH CHICAGO, Ill. and BUDAPEST, Hungary, March 11, 2022 – AbbVie (NYSE: ABBV) and Gedeon Richter Plc. ('Richter') today announced a new co-development and license agreement to research, develop and commercialize novel dopamine receptor modulators for the potential treatment of neuropsychiatric diseases. The collaboration is based on the results of preclinical research carried out by Richter and includes several new chemical entities selected for development. AbbVie and Richter have collaborated for 15 years on Central Nervous System (CNS) projects, including globally launched products such as cariprazine (VRAYLAR® / REAGILA®).", "": "" }, { "Text": "In collaboration with Richter, we will continue to build on our research that seeks to provide additional insights into our understanding of cariprazine's clinical pharmacology and explore novel chemistry to identify new dopamine receptor modulators,\" said Tom Hudson, MD, senior vice president, R&D, chief scientific officer, AbbVie. \"AbbVie is committed to driving progress and finding solutions for patients living with complex neuropsychiatric conditions.", "": "" }, { "Text": "I am very pleased to extend our existing co-operation under this new collaboration with AbbVie as it opens the way towards new products that could help alleviate the debilitating psychiatric and cognitive symptoms of many neuropsychiatric conditions, leading to an improved quality of life for patients suffering from these conditions around the world,\" said Gábor Orbán, CEO of Richter. \"I greatly value AbbVie's capabilities in the field of development and commercialization of drugs acting on the Central Nervous System and we are looking forward to entering this collaboration on new therapeutic options for patients and doctors.", "": "" }, { "Text": "Under the terms of the agreement, the collaboration includes both preclinical and clinical R&D activities with shared financing by the parties. Richter will receive an upfront cash payment, along with potential future development, regulatory and commercialization milestones. In addition, Richter may also receive sales-based royalties. AbbVie will have worldwide commercialization rights except for traditional markets of Richter, such as geographic Europe, Russia, other CIS countries and Vietnam.", "": "" }, { "Text": "The transaction is expected to close in the second quarter of 2022, subject to the satisfaction of customary closing conditions, including applicable regulatory approvals.", "": "" }, { "Text": "About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.", "": "" }, { "Text": "About Richter Gedeon Richter Plc. (www.gedeonrichter.com ), headquartered in Budapest/Hungary, is a major pharmaceutical company in Central Eastern Europe, with an expanding direct presence in Western Europe, in China and in Latin America. Having reached a market capitalization of EUR 4.4 billion (USD 5.0 billion) by the end of 2021, Richter's consolidated sales were approximately EUR 1.8 billion (USD 2.1 billion) during the same year. The product portfolio of Richter covers many important therapeutic areas, including Women's Healthcare, Central Nervous System and Cardiovascular areas. Having the largest R&D unit in Central Eastern Europe, Richter's original research activity focuses on CNS disorders. With its widely acknowledged steroid chemistry expertise, Richter is a significant player in the Women's Healthcare field worldwide. Richter is also active in biosimilar product development.", "": "" }, { "Text": "VRAYLAR (cariprazine) U.S. Uses and Important Safety Information1", "": "" }, { "Text": "INDICATIONS AND USAGE", "": "" }, { "Text": "VRAYLAR is a prescription medicine used in adults: • to treat schizophrenia • for short-term (acute) treatment of manic or mixed episodes that happen with bipolar I disorder • to treat depressive episodes that happen with bipolar I disorder (bipolar depression)", "": "" }, { "Text": "It is not known if VRAYLAR is safe and effective in children.", "": "" }, { "Text": "What is the most important information I should know about VRAYLAR?", "": "" }, { "Text": "Elderly people with dementia-related psychosis (having lost touch with reality due to confusion and memory loss) taking medicines like VRAYLAR are at an increased risk of death. VRAYLAR is not approved for treating patients with dementia-related psychosis.", "": "" }, { "Text": "Antidepressants may increase suicidal thoughts or actions in some children and young adults within the first few months of treatment and when the dose is changed. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Patients on antidepressants and their families or caregivers should watch for new or worsening depression symptoms, especially sudden changes in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant is started or when the dose is changed. Report any change in these symptoms immediately to the doctor.", "": "" }, { "Text": "VRAYLAR may cause serious side effects, including:", "": "" }, { "Text": "• Stroke (cerebrovascular problems) in elderly people with dementia-related psychosis that can lead to death", "": "" }, { "Text": "• Neuroleptic malignant syndrome (NMS): Call your healthcare provider or go to the nearest hospital emergency room right away if you have high fever, stiff muscles, confusion, increased sweating, or changes in breathing, heart rate, and blood pressure. These can be symptoms of a rare but potentially fatal side effect called NMS. VRAYLAR should be stopped if you have NMS", "": "" }, { "Text": "• Uncontrolled body movements (tardive dyskinesia or TD): VRAYLAR may cause movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop taking VRAYLAR. Tardive dyskinesia may also start after you stop taking VRAYLAR", "": "" }, { "Text": "• Late-occurring side effects: VRAYLAR stays in your body for a long time. Some side effects may not happen right away and can start a few weeks after starting VRAYLAR, or if your dose increases. Your healthcare provider should monitor you for side effects for several weeks after starting or increasing dose of VRAYLAR", "": "" }, { "Text": "• Problems with your metabolism, such as: ▪ High blood sugar and diabetes: Increases in blood sugar can happen in some people who take VRAYLAR. Extremely high blood sugar can lead to coma or death. Your healthcare provider should check your blood sugar before or soon after starting VRAYLAR and regularly during treatment. Tell your healthcare provider if you have symptoms such as feeling very thirsty, very hungry, or sick to your stomach, urinating more than usual, feeling weak, tired, confused, or your breath smells fruity ▪ Increased fat levels (cholesterol and triglycerides) in your blood: Your healthcare provider should check fat levels in your blood before or soon after starting VRAYLAR and during treatment ▪ Weight gain: Weight gain has been reported with VRAYLAR. You and your healthcare provider should check your weight before and regularly during treatment", "": "" }, { "Text": "• Low white blood cell count: Low white blood cell counts have been reported with antipsychotic drugs, including VRAYLAR. This may increase your risk of infection. Very low white blood cell counts, which can be fatal, have been reported with other antipsychotics. Your healthcare provider may do blood tests during the first few months of treatment with VRAYLAR", "": "" }, { "Text": "• Decreased blood pressure (orthostatic hypotension): You may feel lightheaded or faint when you rise too quickly from a sitting or lying position", "": "" }, { "Text": "• Falls: VRAYLAR may make you sleepy or dizzy, may cause a decrease in blood pressure when changing position (orthostatic hypotension), and can slow thinking and motor skills, which may lead to falls that can cause fractures or other injuries", "": "" }, { "Text": "• Seizures (convulsions)", "": "" }, { "Text": "• Impaired judgment, thinking, and motor skills: Do NOT drive, operate machinery, or do other dangerous activities until you know how VRAYLAR affects you. VRAYLAR may make you drowsy", "": "" }, { "Text": "• Increased body temperature: Do not become too hot or dehydrated during VRAYLAR treatment. Do not exercise too much. In hot weather, stay inside in a cool place if possible. Stay out of the sun. Do not wear too much clothing or heavy clothing. Drink plenty of water", "": "" }, { "Text": "• Difficulty swallowing that can cause food or liquid to get into your lungs", "": "" }, { "Text": "Who should not take VRAYLAR? Do not take VRAYLAR if you are allergic to any of its ingredients. Get emergency medical help if you are having an allergic reaction (eg, rash, itching, hives, swelling of the tongue, lip, face or throat).", "": "" }, { "Text": "What should I tell my healthcare provider before taking VRAYLAR? Tell your healthcare provider about any medical conditions and if you: • have or have had heart problems or a stroke • have or have had low or high blood pressure • have or have had diabetes or high blood sugar in you or your family • have or have had high levels of total cholesterol, LDL-cholesterol, or triglycerides; or low levels of HDL-cholesterol • have or have had seizures (convulsions) • have or have had kidney or liver problems • have or have had low white blood cell count • are pregnant or plan to become pregnant. VRAYLAR may harm your unborn baby. Talk to your healthcare provider about the risk to your unborn baby if you take VRAYLAR during pregnancy. If you become pregnant or think you are pregnant during treatment, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or http://www.womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/  • are breastfeeding or plan to breastfeed. It is not known if VRAYLAR passes into breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with VRAYLAR", "": "" }, { "Text": "Tell your healthcare provider about all medicines that you take, including prescriptions, over-the-counter medicines, vitamins, and supplements. VRAYLAR may affect the way other medicines work, and other medicines may affect how VRAYLAR works. Do not start or stop any medicines while taking VRAYLAR without talking to your healthcare provider.", "": "" }, { "Text": "What are the most common side effects of VRAYLAR? The most common side effects were difficulty moving or slow movements, tremors, uncontrolled body movements, restlessness and feeling like you need to move around, sleepiness, nausea, vomiting, and indigestion.", "": "" }, { "Text": "These are not all possible side effects of VRAYLAR.", "": "" }, { "Text": "You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch  or call 1-800-FDA-1088.", "": "" }, { "Text": "If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more.", "": "" }, { "Text": "Please click here for Full Prescribing Information and Medication Guide for VRAYLAR.", "": "" }, { "Text": "Globally, prescribing information varies; refer to the individual country product label for complete information.", "": "" }, { "Text": "References:", "": "" }, { "Text": "1. VRAYLAR (cariprazine) [package insert]. Madison, NJ: Allergan USA, Inc.", "": "" }, { "Text": "Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words \"believe,\" \"expect,\" \"anticipate,\" \"project\" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits from AbbVie's acquisition of Allergan plc (\"Allergan\"), failure to promptly and effectively integrate Allergan's businesses, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, \"Risk Factors,\" of AbbVie's 2021 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.", "": "" }, { "Text": "###", "": "" }, { "Text": "AbbVie Media: Frank Benenati +1 (847) 938-8745 Frank.Benenati@abbvie.com", "": "" }, { "Text": "Richter Media: Zsuzsa Beke +36 1 431 4888 zs.beke@richter.hu", "": "" }, { "Text": "AbbVie Investors: Liz Shea +1 (847) 935-2211 Liz.Shea@abbvie.com", "": "" }, { "Text": "Richter Investors: Katalin Ördög +36 1 431 5680 k.ordog@richter.hu", "": "" }, { "Text": "-57-", "": "" }, { "Text": "99450416_50", "": "" }, { "Text": "Schedule 10.2.1", "": "" }, { "Text": "Existing Patents", "": "" }, { "Text": "None.", "": "" }, { "Text": "Part A: Owned Patents", "": "" }, { "Text": "None.", "": "" }, { "Text": "Part B: In-Licensed Patents", "": "" }, { "Text": "None.", "": "" }, { "Text": "-58-", "": "" }, { "Text": "99450416_50", "": "" }, { "Text": "Schedule 12.9.1", "": "" }, { "Text": "Reversion Royalties Dispute Resolution", "": "" }, { "Text": "Royalty Dispute\" means any dispute regarding the royalty rates for the licenses granted to Richter by AbbVie in Section 12.7.1(c) or Section 12.8(b) that have not been resolved by good faith negotiation and consultation between the Parties and have been referred for resolution under this Schedule 12.9.1 as set forth in Section 12.9.1.", "": "" }, { "Text": "1. Referral to Executive Officers. All Royalty Disputes will first be referred to the Executive Officers for attempted resolution by good faith negotiation within thirty (30) days after receiving written notification of referral of such Royalty Dispute or such longer period of time as the Executive Officers may agree in writing. Any final decision agreed to by the Executive Officers with respect to such Royalty Dispute and set forth in writing will be conclusive and binding on the Parties.", "": "" }, { "Text": "2. Final Offer. If the Executive Officers are unable to resolve a Royalty Dispute in accordance with paragraph 1, then each Party will (a) prepare a proposal of the royalty rates for the licenses granted to AbbVie to Richter under in Section 12.7.1(c) or Section 12.8(b), as applicable, to be considered by a Valuation Expert (each, an \"Final Offer\") and (b) submit its Final Offer to the other Party. Within fifteen (15) days of such submissions, the Parties will meet to determine whether they agree to enter into either Party's Final Offer or a modified version thereof as the financial terms of the applicable licenses granted to AbbVie to Richter.", "": "" }, { "Text": "3. Valuation Expert. If the Parties are unable to agree within the fifteen (15)-day period set forth above in paragraph 2 of this Schedule 12.9.1, then, upon written notice of a Party (a \"Valuation Notice\"), the Parties will engage one (1) independent, impartial and neutral Third Party valuation expert (a \"Valuation Expert\") to determine the commercially reasonable royalty rate at issue in such Royalty Dispute. The Valuation Expert shall be mutually agreed to by the Parties; provided that if the Parties are unable to agree on one (1) Valuation Expert within fifteen (15) Business Days after the date of the Valuation Notice, then each Party shall select one (1) Valuation Expert and those two (2) Valuation Experts will select the one (1) Valuation Expert within fifteen (15) Business Days thereafter, which one (1) Valuation Expert selected shall determine the commercially reasonably royalty; provided further that such selected Valuation Expert shall not be a current or former employee, officer, director, consultant or subcontractor of either Party or any of its Affiliates. The Parties shall use their best efforts to cause the one (1) Valuation Expert to be selected and retained within sixty (60) days after the date of the Valuation Notice.", "": "" }, { "Text": "4. Selection of One Final Offer. Within thirty (30) days after appointment of the Valuation Expert, each Party will deliver to the Valuation Expert and the other Party a copy of such Party's Final Offer for the applicable Royalty Dispute, which Final Offer will be identical to the Final Offer previously shared with the other Party as set forth in paragraph 2 and a summary explaining why its Final Offer is appropriate. The Valuation Expert will be instructed to review each Final Offer and summary proposed by each of the Parties within sixty (60) days following the receipt of the latter of such Final Offers and to select without modification the Final Offer that they determine most accurately reflects the fair market value of Richter's license to the AbbVie Grantback Technology taking into account, among other things, (a) the stage of Development or Commercialization of the Licensed Products at the time of termination, (b) AbbVie's financial contribution to the Exploitation of the Licensed Products after the Effective Date and prior to the effective date of termination, and (c) the nature of the AbbVie Grantback Technology.", "": "" }, { "Text": "5. Fees for Arbitration. The fees for the Valuation Expert will be borne by the Party whose Final Offer is not selected by the Valuation Expert.", "": "" }, { "Text": "6. Confidentiality of Proceedings. Except as set forth below, the Parties will keep confidential the engagement of the Valuation Expert, the dispute being resolved, and the decision of the Valuation Expert. Notwithstanding the foregoing, the Parties may disclose information about the proceeding to persons who have a need to know, such as directors, trustees, management employees, witnesses, experts, attorneys, lenders, insurers, and others who may be directly affected by the outcome of the applicable Royalty Dispute. Additionally, a Party may make such disclosures as are required by Applicable Law or, if such Party is publicly traded, regulations of any stock exchange upon which securities are traded or listed, but will use reasonable efforts to seek confidential treatment for such disclosure.", "": "" }, { "Text": "-60-", "": "" }, { "Text": "99450416_50", "": "" }, { "Text": "Schedule 13.7.3", "": "" }, { "Text": "ADR Procedures", "": "" }, { "Text": "Any Dispute referred to ADR under this Agreement shall be resolved as follows:", "": "" }, { "Text": "1. To begin an ADR proceeding, a Party shall provide written notice to the other Party of the Dispute to be resolved by ADR. Within fourteen (14) days after such notice is given, the other Party may, by written notice to the Party initiating the arbitration, add additional issues to be resolved within the same ADR.", "": "" }, { "Text": "2. Within twenty-one (21) days following the initiation of the ADR proceeding, the Parties shall select a mutually acceptable independent, impartial and conflicts-free neutral to preside in the resolution of all issues in this ADR proceeding. If the Parties are unable to agree on a mutually acceptable neutral within such period, each Party will select one (1) independent, impartial and conflicts-free neutral and those two (2) neutrals will select a third independent, impartial and conflicts-free neutral within ten (10) days thereafter (such neutral(s), the \"Neutral\"). None of the neutrals selected may be current or former employees, contractors, advisors, counsel, officers or directors of either Party or its Affiliates.", "": "" }, { "Text": "3. No earlier than twenty-eight (28) days or later than fifty-six (56) days after selection, the Neutral shall hold a hearing to resolve each of the issues identified by the Parties. The ADR proceeding shall take place at a location agreed upon by the Parties. If the Parties cannot agree, the Neutral shall designate a location other than the principal place of business of either Party or any of their Affiliates.", "": "" }, { "Text": "4. At least seven (7) days prior to the hearing, each Party shall submit the following to the other Party and the Neutral:", "": "" }, { "Text": "(a) a copy of all exhibits on which such Party intends to rely in any oral or written presentation to the Neutral;", "": "" }, { "Text": "(b) a list of any witnesses such Party intends to call at the hearing, and a short summary of the anticipated testimony of each witness;", "": "" }, { "Text": "(c) a proposed ruling on each issue to be resolved, together with a request for a specific damage award, set of actions to be taken to cure the other Party's breach, or other remedy for each issue; such remedies being cumulative and not exclusive. The proposed ruling shall not contain any recitation of the facts, and the proposed remedy shall not include any punitive damages. The proposed ruling and the proposed remedy collectively shall not exceed one (1) page per issue; and", "": "" }, { "Text": "(d) a brief in support of such Party's proposed rulings and remedies; provided, that the brief shall not exceed thirty (30) pages. This page limitation shall apply regardless of the number of issues raised in the ADR proceeding.", "": "" }, { "Text": "Except as expressly set forth in subparagraphs 4(a) - 4(d), no discovery shall be required or permitted by any means, including depositions, interrogatories, requests for admissions, or production of documents.", "": "" }, { "Text": "5. The hearing shall be conducted on two (2) consecutive days and shall be governed by the following rules:", "": "" }, { "Text": "(a) Each Party shall be entitled to five (5) hours of hearing time to present its case. The Neutral shall determine whether each Party has had the five (5) hours to which it is entitled.", "": "" }, { "Text": "(b) Each Party shall be entitled, but not required, to make an opening statement, to present regular and rebuttal testimony, documents, or other evidence, to cross-examine witnesses, and to make a closing argument. Cross-examination of witnesses shall occur immediately after their direct testimony, and cross-examination time shall be charged against the Party conducting the cross-examination.", "": "" }, { "Text": "(c) The Party initiating the ADR shall begin the hearing and, if it chooses to make an opening statement, shall address therein not only issues it raised but also any issues raised by the responding Party. The responding Party, if it chooses to make an opening statement, also shall address all issues raised in the ADR. Thereafter, the presentation of regular and rebuttal testimony and documents, other evidence, and closing arguments shall proceed in the same sequence.", "": "" }, { "Text": "(d) Except when testifying, witnesses shall be excluded from the hearing until closing arguments.", "": "" }, { "Text": "(e) Settlement negotiations, including any statements made therein, shall not be admissible under any circumstances. Affidavits prepared for purposes of the ADR hearing shall be admissible. As to all other matters, the Neutral shall follow the Federal Rules of Evidence then-applicable in the United States of America.", "": "" }, { "Text": "6. Within seven (7) days following completion of the hearing, each Party may submit to the other Party and the Neutral a post-hearing brief in support of its proposed rulings and remedies, including without limitation actions to be taken to cure the breach; provided, that such brief shall not contain or discuss any new evidence and shall not exceed fifteen (15) pages. This page limitation shall apply regardless of the number of issues raised in the ADR proceeding.", "": "" }, { "Text": "7. The Neutral shall rule on each disputed issue within fourteen (14) days following completion of the hearing. Such ruling shall adopt in its entirety the proposed ruling and remedy of one (1) of the Parties on each disputed issue but may adopt one (1) Party's proposed rulings and remedies on some issues and the other Party's proposed rulings and remedies on other issues. The Neutral shall not issue any written opinion or otherwise explain the basis of the ruling.", "": "" }, { "Text": "8. The Neutral shall be paid a reasonable fee plus expenses. These fees and expenses, along with the reasonable legal fees and expenses of the prevailing Party (including all expert witness fees and expenses), the fees and expenses of a court reporter, and any expenses for a hearing room, shall be paid as follows:", "": "" }, { "Text": "(a) If the Neutral rules in favor of one (1) Party on all disputed issues in the ADR, the losing Party shall pay one hundred percent (100%) of such fees and expenses.", "": "" }, { "Text": "(b) If the Neutral rules in favor of one (1) Party on some issues and the other Party on other issues, the Neutral shall issue with the rulings a written determination as to how such fees and expenses shall be allocated between the Parties. The Neutral shall allocate fees and expenses in a way that bears a reasonable relationship to the outcome of the ADR, with the Party prevailing on more issues, or on issues of greater value or gravity, recovering a relatively larger share of its legal fees and expenses.", "": "" }, { "Text": "9. The rulings of the Neutral and the allocation of fees and expenses shall be binding, non-reviewable, and non-appealable, and may be entered as a final judgment in the Courts of the State of New York, New York County, or, if it has or may acquire subject matter jurisdiction, the United States District Court for the Southern District of New York, or in any other court of competent jurisdiction.", "": "" }, { "Text": "10. Except as provided in paragraph 9 or as required by law, the existence of the Dispute, any settlement negotiations, the ADR proceeding, any submissions (including exhibits, testimony, proposed rulings, and briefs), and the rulings shall be deemed to be Confidential Information of both Parties. The Neutral shall have the authority to impose sanctions for unauthorized disclosure of Confidential Information.", "": "" }, { "Text": "11. All ADR proceedings shall be conducted in the English language.", "": "" }, { "Text": "12. Each Party shall have the right to be represented by counsel in all aspects of any ADR proceeding.", "": "" }, { "Text": "EXECUTION VERSION", "": "" }, { "Text": "AMENDED AND RESTATED COLLABORATION AND OPTION AGREEMENT", "": "" }, { "Text": "between", "": "" }, { "Text": "CAPSIDA BIOTHERAPEUTICS, INC.", "": "" }, { "Text": "and", "": "" }, { "Text": "ABBVIE GLOBAL ENTERPRISES LTD.", "": "" }, { "Text": "Dated as of February 17, 2023", "": "" }, { "Text": "TABLE OF CONTENTS", "": "" }, { "Text": "Page", "": "" }, { "Text": "ARTICLE 1 DEFINITIONS ........................................................................................................... 2", "": "" }, { "Text": "ARTICLE 2 RESEARCH PROGRAM ........................................................................................ 42", "": "" }, { "Text": "2.1 General. ................................................................................................................. 42", "": "" }, { "Text": "2.2 Research Plans. ..................................................................................................... 43", "": "" }, { "Text": "2.3 Capsid Generation, Optimization and Screening. ................................................. 44", "": "" }, { "Text": "2.4 AbbVie Materials. ................................................................................................. 50", "": "" }, { "Text": "2.5 Program Activities and Efforts. ............................................................................ 50", "": "" }, { "Text": "2.6 Performance of Research Program and other Activities. ...................................... 51", "": "" }, { "Text": "2.7 Research Program Costs. ...................................................................................... 52", "": "" }, { "Text": "2.8 Transferred Materials. ........................................................................................... 53", "": "" }, { "Text": "2.9 No Guarantee. ....................................................................................................... 53", "": "" }, { "Text": "2.10 Specific Performance. ........................................................................................... 53", "": "" }, { "Text": "ARTICLE 2A OPHTHALMOLOGY RESEARCH PROGRAM ................................................ 53", "": "" }, { "Text": "2.11 General. ................................................................................................................. 53", "": "" }, { "Text": "2.12 Ophthalmology Research Plan. ............................................................................. 55", "": "" }, { "Text": "2.13 Ophthalmology Research Program Activities. ..................................................... 56", "": "" }, { "Text": "2.14 Target Selection. ................................................................................................... 64", "": "" }, { "Text": "2.15 AbbVie Materials. ................................................................................................. 66", "": "" }, { "Text": "2.16 Program Activities and Efforts. ............................................................................ 67", "": "" }, { "Text": "2.17 Performance of Research Program and other Activities. ...................................... 67", "": "" }, { "Text": "2.18 Ophthalmology Research Program Costs. ............................................................ 69", "": "" }, { "Text": "2.19 Transferred Materials. ........................................................................................... 69", "": "" }, { "Text": "2.20 No Guarantee. ....................................................................................................... 69", "": "" }, { "Text": "2.21 Specific Performance. ........................................................................................... 70", "": "" }, { "Text": "ARTICLE 3 EXCLUSIVE OPTIONS.......................................................................................... 70", "": "" }, { "Text": "3.1 Option Grants. ....................................................................................................... 70", "": "" }, { "Text": "3.2 Delivery of Final Data Packages. .......................................................................... 70", "": "" }, { "Text": "3.3 Option Exercise. .................................................................................................... 71", "": "" }, { "Text": "3.4 Capsida Transition Obligations on Option Exercise. ............................................ 71", "": "" }, { "Text": "3.5 Allocation of Rights with Respect to Transferred Contracts. ............................... 73", "": "" }, { "Text": "3.6 HSR. ...................................................................................................................... 74", "": "" }, { "Text": "3.7 Non-Exercise of Options....................................................................................... 75", "": "" }, { "Text": "ARTICLE 4 DEVELOPMENT .................................................................................................... 77", "": "" }, { "Text": "4.1 Licensed Capsid Products and Licensed Ophthalmology Products. ..................... 77", "": "" }, { "Text": "4.2 ALS Product.......................................................................................................... 78", "": "" }, { "Text": "4.3 ALS Product Regulatory Activities. ..................................................................... 81", "": "" }, { "Text": "4.4 ALS Reversion Product. ....................................................................................... 82", "": "" }, { "Text": "4.5 Regulatory Support. .............................................................................................. 84", "": "" }, { "Text": "4.6 Shared Capsid Safety Information and Use. ......................................................... 84", "": "" }, { "Text": "4.7 Additional Disclosures to AbbVie. ....................................................................... 84", "": "" }, { "Text": "ARTICLE 5 MANUFACTURING............................................................................................... 84", "": "" }, { "Text": "5.1 Manufacturing Responsibilities Prior to Option Exercise. ................................... 84", "": "" }, { "Text": "5.2 Manufacturing After Option Exercise. ................................................................. 86", "": "" }, { "Text": "5.3 Manufacturing Technology Transfer and Continued Improvement. .................... 86", "": "" }, { "Text": "ARTICLE 6 COMMERCIALIZATION ...................................................................................... 90", "": "" }, { "Text": "6.1 General. ................................................................................................................. 90", "": "" }, { "Text": "6.2 Booking of Sales; Distribution. ............................................................................ 90", "": "" }, { "Text": "6.3 Commercialization of ALS Products. ................................................................... 90", "": "" }, { "Text": "6.4 Commercialization Reports. ................................................................................. 93", "": "" }, { "Text": "ARTICLE 7 MANAGEMENT OF THE COLLABORATION ................................................... 93", "": "" }, { "Text": "7.1 Joint Governance Committee. ............................................................................... 93", "": "" }, { "Text": "7.2 General Provisions Applicable to the JGCs. ......................................................... 95", "": "" }, { "Text": "7.3 Working Groups.................................................................................................... 98", "": "" }, { "Text": "7.4 Alliance Managers. ............................................................................................. 100", "": "" }, { "Text": "ARTICLE 8 GRANT OF RIGHTS; EXCLUSIVITY ................................................................ 100", "": "" }, { "Text": "8.1 Grants to AbbVie. ............................................................................................... 100", "": "" }, { "Text": "8.2 Grants to Capsida. ............................................................................................... 102", "": "" }, { "Text": "8.3 Sublicenses. ......................................................................................................... 103", "": "" }, { "Text": "8.4 In-License Agreements. ...................................................................................... 103", "": "" }, { "Text": "8.5 Section intentionally left blank. .......................................................................... 106", "": "" }, { "Text": "8.6 Retention of Rights. ............................................................................................ 106", "": "" }, { "Text": "8.7 Confirmatory Patent License. ............................................................................. 106", "": "" }, { "Text": "8.8 Exclusivity. ......................................................................................................... 106", "": "" }, { "Text": "ARTICLE 9 PAYMENTS AND RECORDS ............................................................................. 109", "": "" }, { "Text": "9.1 Upfront Payment and First Final Ophthalmology Data Package Payment......... 109", "": "" }, { "Text": "9.2 Equity Investment. .............................................................................................. 110", "": "" }, { "Text": "9.3 Option Exercise and Additional Capsid Program Payments. ............................. 110", "": "" }, { "Text": "9.4 α-syn and Tau Milestones. .................................................................................. 111", "": "" }, { "Text": "9.5 Final Selected Ophthalmology Target Milestones. ............................................. 114", "": "" }, { "Text": "9.6 AbbVie Royalties. ............................................................................................... 116", "": "" }, { "Text": "9.7 Third Party Payments. ......................................................................................... 118", "": "" }, { "Text": "9.8 Estimated Sales Levels. ...................................................................................... 119", "": "" }, { "Text": "9.9 Royalty Payments and Reports. .......................................................................... 119", "": "" }, { "Text": "9.10 Capsida ALS Reversion Product Milestones. ..................................................... 119", "": "" }, { "Text": "9.11 Capsida ALS Reversion Product Royalties. ....................................................... 120", "": "" }, { "Text": "9.12 Capsida ALS Reversion Product Third Party Payments..................................... 122", "": "" }, { "Text": "9.13 Profit Share for ALS Products in the Territory. .................................................. 123", "": "" }, { "Text": "9.14 Calculation and Payment of Co-Development Cost Share and Net Profit or Net Loss Share. ................................................................................................... 123", "": "" }, { "Text": "9.15 FTE Costs............................................................................................................ 124", "": "" }, { "Text": "9.16 Other Invoiced Amounts. .................................................................................... 124", "": "" }, { "Text": "9.17 Nonrefundability; Mode of Payment. ................................................................. 125", "": "" }, { "Text": "9.18 Taxes. .................................................................................................................. 125", "": "" }, { "Text": "9.19 Interest on Late Payments. .................................................................................. 126", "": "" }, { "Text": "9.20 Financial Records................................................................................................ 126", "": "" }, { "Text": "9.21 Audit. .................................................................................................................. 126", "": "" }, { "Text": "9.22 Right to Offset..................................................................................................... 127", "": "" }, { "Text": "9.23 Diagnostic or Veterinary Products. ..................................................................... 127", "": "" }, { "Text": "ARTICLE 10 INTELLECTUAL PROPERTY .......................................................................... 127", "": "" }, { "Text": "10.1 Ownership of Intellectual Property. .................................................................... 127", "": "" }, { "Text": "10.2 Maintenance and Prosecution of Patents. ........................................................... 130", "": "" }, { "Text": "10.3 Enforcement of Patents. ...................................................................................... 133", "": "" }, { "Text": "10.4 Invalidity or Unenforceability Defense or Actions. ............................................ 136", "": "" }, { "Text": "10.5 Infringement Claimed by Third Parties. ............................................................. 137", "": "" }, { "Text": "10.6 Third Party Licenses and Patents. ....................................................................... 138", "": "" }, { "Text": "10.7 Inventor's Remuneration. ................................................................................... 138", "": "" }, { "Text": "10.8 International Nonproprietary Name. ................................................................... 139", "": "" }, { "Text": "10.9 Common Interest. ................................................................................................ 139", "": "" }, { "Text": "10.10 Product Trademarks. ........................................................................................... 139", "": "" }, { "Text": "ARTICLE 11 CONFIDENTIALITY AND NON-DISCLOSURE ............................................ 140", "": "" }, { "Text": "11.1 Confidentiality Obligations. ................................................................................ 140", "": "" }, { "Text": "11.2 Permitted Disclosures. ........................................................................................ 142", "": "" }, { "Text": "11.3 Additional Permitted Disclosures. ...................................................................... 143", "": "" }, { "Text": "11.4 Use of Name. ...................................................................................................... 144", "": "" }, { "Text": "11.5 Public Announcements. ...................................................................................... 144", "": "" }, { "Text": "11.6 Publications. ........................................................................................................ 145", "": "" }, { "Text": "ARTICLE 12 REPRESENTATIONS AND WARRANTIES .................................................... 146", "": "" }, { "Text": "12.1 Mutual Representations and Warranties. ............................................................ 146", "": "" }, { "Text": "12.2 Representations, and Warranties of Capsida for the Neurology Program. ......... 147", "": "" }, { "Text": "12.3 Representations, and Warranties of Capsida for the Ophthalmology Program. .............................................................................................................. 151", "": "" }, { "Text": "12.4 Additional Representations and Warranties of Capsida as of the Option Bringdown Date. ................................................................................................. 156", "": "" }, { "Text": "12.5 Updated Disclosure Schedule and Bringdown. .................................................. 157", "": "" }, { "Text": "12.6 Mutual Covenants. .............................................................................................. 157", "": "" }, { "Text": "12.7 Additional Covenants of Capsida. ...................................................................... 158", "": "" }, { "Text": "12.8 Additional Representations and Warranties with respect to ALS Cargo and AbbVie Ophthalmology Cargo and AbbVie Obligations; Additional Acknowledgements. ............................................................................................ 160", "": "" }, { "Text": "12.9 Data Privacy and Security. .................................................................................. 161", "": "" }, { "Text": "12.10 DISCLAIMER OF WARRANTIES. .................................................................. 162", "": "" }, { "Text": "12.11 Anti-Bribery and Anti-Corruption Compliance. ................................................. 162", "": "" }, { "Text": "ARTICLE 13 INDEMNITY ....................................................................................................... 163", "": "" }, { "Text": "13.1 Indemnification of Capsida. ................................................................................ 163", "": "" }, { "Text": "13.2 Indemnification of AbbVie. ................................................................................ 163", "": "" }, { "Text": "13.3 Certain Losses. .................................................................................................... 164", "": "" }, { "Text": "13.4 Indemnification Procedures. ............................................................................... 165", "": "" }, { "Text": "13.5 Insurance. ............................................................................................................ 167", "": "" }, { "Text": "13.6 Limitation of Liability......................................................................................... 167", "": "" }, { "Text": "ARTICLE 14 TERM AND TERMINATION ............................................................................ 167", "": "" }, { "Text": "14.1 Term and Expiration. .......................................................................................... 167", "": "" }, { "Text": "14.2 Termination. ........................................................................................................ 168", "": "" }, { "Text": "14.3 Rights in Bankruptcy. ......................................................................................... 169", "": "" }, { "Text": "14.4 Modification In Lieu of Termination. ................................................................. 170", "": "" }, { "Text": "14.5 Consequences of Termination............................................................................. 171", "": "" }, { "Text": "14.6 Remedies. ............................................................................................................ 175", "": "" }, { "Text": "14.7 Accrued Rights; Surviving Obligations. ............................................................. 175", "": "" }, { "Text": "ARTICLE 15 MISCELLANEOUS ............................................................................................ 175", "": "" }, { "Text": "15.1 Force Majeure. .................................................................................................... 176", "": "" }, { "Text": "15.2 Export Control. ................................................................................................... 176", "": "" }, { "Text": "15.3 Assignment. ........................................................................................................ 176", "": "" }, { "Text": "15.4 Certain Strategic Transactions. ........................................................................... 178", "": "" }, { "Text": "15.5 Severability. ........................................................................................................ 179", "": "" }, { "Text": "15.6 Dispute Resolution. ............................................................................................. 179", "": "" }, { "Text": "15.7 Governing Law, Jurisdiction and Service. .......................................................... 180", "": "" }, { "Text": "15.8 Notices. ............................................................................................................... 180", "": "" }, { "Text": "15.9 Entire Agreement; Amendments......................................................................... 181", "": "" }, { "Text": "15.10 English Language................................................................................................ 181", "": "" }, { "Text": "15.11 Equitable Relief. ................................................................................................. 182", "": "" }, { "Text": "15.12 Waiver and Non-Exclusion of Remedies. ........................................................... 182", "": "" }, { "Text": "15.13 No Benefit to Third Parties. ................................................................................ 182", "": "" }, { "Text": "15.14 Further Assurance. .............................................................................................. 182", "": "" }, { "Text": "15.15 Relationship of the Parties. ................................................................................. 182", "": "" }, { "Text": "15.16 References. .......................................................................................................... 183", "": "" }, { "Text": "15.17 Construction. ....................................................................................................... 183", "": "" }, { "Text": "15.18 Counterparts. ....................................................................................................... 183", "": "" }, { "Text": "ARTICLE 16 AMENDMENT AND RESTATEMENT ............................................................ 183", "": "" }, { "Text": "16.1 Amendment and Restatement. ............................................................................ 183", "": "" }, { "Text": "SCHEDULES AND EXHIBITS", "": "" }, { "Text": "Exhibit A Capsid Program Research Plan", "": "" }, { "Text": "Exhibit B Collaboration Program Research Plan", "": "" }, { "Text": "Exhibit C POC Plan", "": "" }, { "Text": "Exhibit D Ophthalmology Research Plan", "": "" }, { "Text": "Exhibit E Initial Target List", "": "" }, { "Text": "Schedule 1.56 Trademarks and logos", "": "" }, { "Text": "Schedule 1.1.75 Existing Capsids", "": "" }, { "Text": "Schedule 1.88 FTE Rate", "": "" }, { "Text": "Schedule 5.1.2 Existing CMO Agreements", "": "" }, { "Text": "Schedule 6.3.3 Co-Promotion Readiness Plan", "": "" }, { "Text": "Schedule 11.5A Press Release for Neurology Program", "": "" }, { "Text": "Schedule 11.5B Press Release for Ophthalmology Program", "": "" }, { "Text": "Schedule 12.2 Initial Neurology Disclosure Schedule", "": "" }, { "Text": "Schedule 12.2.1 Existing In-License Agreements for Neurology Program", "": "" }, { "Text": "Schedule 12.2.4 Existing NP Patents", "": "" }, { "Text": "Schedule 12.3.1 Existing In-License Agreements for Ophthalmology Program", "": "" }, { "Text": "Schedule 12.3.4 Existing OP Patents", "": "" }, { "Text": "Schedule 15.6.3 ADR Procedures", "": "" }, { "Text": "AMENDED AND RESTATED COLLABORATION AND OPTION AGREEMENT", "": "" }, { "Text": "This Amended and Restated Collaboration and Option Agreement (this \"Agreement\") is made and entered into as of February 17, 2023 (the \"Effective Date\") by and between Capsida Biotherapeutics, Inc., a Delaware corporation (\"Capsida\") and AbbVie Global Enterprises Ltd., a Bermuda corporation (\"AbbVie\"). Capsida and AbbVie are sometimes referred to herein individually as a \"Party\" and collectively as the \"Parties.", "": "" }, { "Text": "RECITALS", "": "" }, { "Text": "WHEREAS, Capsida owns and controls certain intellectual property rights with respect to the Capsida Platform (as defined below) in the Territory (as defined below);", "": "" }, { "Text": "WHEREAS, AbbVie controls certain intellectual property rights relating to the AbbVie Cargo (as defined below);", "": "" }, { "Text": "WHEREAS, Capsida and AbbVie entered into that certain Collaboration and Option Agreement, dated April 26, 2021 (such agreement the \"Original Agreement\" and such date the \"Original Agreement Effective Date\"), pursuant to which (i) the Parties agreed to collaborate on research activities aimed at identifying and optimizing capsids using the Capsida Platform for delivery of AbbVie Cargo directed to the Targets (as defined below) in the brain or spinal cord in accordance with the terms set forth below, and (ii) Capsida granted to AbbVie options to take exclusive licenses under such intellectual property rights to Exploit (as defined below) Licensed Products (as defined below) in the Territory, in accordance with the terms and conditions set forth below (the \"Original Neurology Rights\").", "": "" }, { "Text": "WHEREAS, the Parties now desire to amend and restate the Original Agreement as of the Effective Date (i) to include an Ophthalmology Research Program (as defined below) under which the Parties desire to collaborate on research activities aimed at identifying and optimizing capsids using the Capsida Platform for delivery of AbbVie Cargo in the eye, in accordance with the terms set forth below, and (ii) under which Capsida wishes to grant, and AbbVie wishes to obtain, options to take exclusive licenses under such intellectual property rights to Exploit Licensed Ophthalmology Capsids and Licensed Ophthalmology Products (as each term is defined below) (the \"Ophthalmology Rights\").", "": "" }, { "Text": "WHEREAS, the Parties have agreed to amend and restate the Original Agreement as set out in this Agreement and effective as of the Effective Date, to replace and supersede the Original Agreement with this Agreement.", "": "" }, { "Text": "NOW, THEREFORE, in consideration of the premises and the mutual promises and conditions set forth herein and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, do hereby agree as follows:", "": "" }, { "Text": "ARTICLE 1 DEFINITIONS", "": "" }, { "Text": "Unless otherwise specifically provided herein, the following terms shall have the following meanings:", "": "" }, { "Text": "1.1 \"α-syn\" means the alpha synuclein gene designated SNCA (as exemplified by NCBI Reference Sequence Database record NM_000345) including all DNA haplotypes, gene duplications, polymorphisms, mutations or allelic variants of the SNCA locus, all mRNA products derived from the complete or partial SNCA gene (e.g., splice variants, missense mutations, truncations) and all forms of the α-synuclein protein (e.g., isoforms, fragments, mutations, conformations, posttranslational modifications, aggregate forms, intrinsically disordered proteins or other forms thereof) in human and other species.", "": "" }, { "Text": "1.2 \"AbbVie Background IP\" means the AbbVie Background Know-How and the AbbVie Background Patents.", "": "" }, { "Text": "1.3 \"AbbVie Background Know-How\" means all information (including regulatory data, Know-How relating to Manufacture of Capsids, files, approvals and other documentation) and other Know-How that (a) with respect to the Research Program, (i) is owned or Controlled by AbbVie or any of its Affiliates as of the Original Agreement Effective Date or is conceived, discovered, generated, created, developed, acquired or otherwise made outside of the Research Program, the POC Plan or the Ophthalmology Research Program, (ii) is not generally known and (iii) is necessary or reasonably useful to use AbbVie Cargo or other AbbVie Material for Permitted Uses under the Research Program (\"AbbVie Background Know-How for Research Program\") or to Research, Develop and Commercialize ALS Products in the Field in the Territory under the POC Plan, the ALS Development Plan and Budget or the ALS Commercialization Plan (\"AbbVie Background Know-How for ALS\"), or (b) with respect to the Ophthalmology Research Program, (i) is owned or Controlled by AbbVie or any of its Affiliates as of the Effective Date or is conceived, discovered, generated, created, developed, acquired or otherwise made outside of the Ophthalmology Research Program, the Research Program or the POC Plan, (ii) is not generally known and (iii) is necessary or reasonably useful to use AbbVie Ophthalmology Cargo or other AbbVie Material for Permitted Uses under the Ophthalmology Research Program (\"AbbVie Background Know-How for Ophthalmology Research Program\") as applicable, but excluding, in each case ((a) and (b)), any Know-How within the Capsida Platform Know-How, Cargo Know-How or Program Know-How.", "": "" }, { "Text": "1.4 \"AbbVie Background Patents\" means all Patents owned or Controlled by AbbVie or its Affiliates and issued or filed (a) with respect to the Research Program, (i) as of the Original Agreement Effective Date or (ii) that is conceived, discovered, generated, created, developed, acquired or otherwise made outside of the Research Program, the POC Plan or the Ophthalmology Research Program during the Term in each case ((i) and (ii)) that cover the use of AbbVie Cargo or other AbbVie Materials and that are necessary or reasonably useful (or, with respect to patent applications, would be necessary or reasonably useful if such patent applications were to issue as patents) for Permitted Uses under the Research Program (\"AbbVie Background Patents for Research Program\") or the Research, Development and Commercialization of ALS Products in the Field in the Territory under the POC Plan, the ALS Development Plan and Budget or the ALS Commercialization Plan, as applicable, (\"AbbVie Background Patents for ALS\"), or (b) with respect to the Ophthalmology Research Program, (i) as of the Effective Date or (ii) that is conceived, discovered, generated, created, developed, acquired or otherwise made outside of the Ophthalmology Research Program, the Research Program or the POC Plan during the Term in each case ((i) and (ii)) that cover the use of AbbVie Ophthalmology Cargo or other AbbVie Materials and that are necessary or reasonably useful (or, with respect to patent applications, would be necessary or reasonably useful if such patent applications were to issue as patents) for Permitted Uses under the Ophthalmology Research Program (\"AbbVie Background Patents for Ophthalmology Research Program\"), but excluding, in each case ((a) and (b)), any Cargo Patents, Capsida Platform Patents or the Program Patents.", "": "" }, { "Text": "1.5 \"AbbVie Cargo\" means (a) any compound, molecule, biologic or other moiety directed to α-syn, Tau or TDP-43 made available by AbbVie for use in the Research Program, or otherwise included by or on behalf of AbbVie in a Licensed Product during the Term, and any polynucleotide or other genetic material that encodes such compound, molecule, biologic or moiety, (b) any polynucleotide or other genetic material that is directed to α-syn, Tau or TDP-43 made available by AbbVie for use in the Research Program, or otherwise included by or on behalf of AbbVie in a Licensed Product during the Term and any compound, molecule, biologic or moiety expressed thereby, and (c) any modifications, enhancements, improvements or derivatives of any of the foregoing.", "": "" }, { "Text": "1.6 \"AbbVie Indications\" means collectively dAMD, GA, wAMD, DME, DR, and Glaucoma, each of which individually is an \"AbbVie Indication\".", "": "" }, { "Text": "1.7 \"AbbVie Ophthalmology Cargo\" means any (a) compound, molecule, biologic or other moiety directed to an Ophthalmology Target that is made available by AbbVie for use in the Ophthalmology Research Program or otherwise included by or on behalf of AbbVie in a Licensed Ophthalmology Product during the Term, and any polynucleotide or other genetic material that encodes such compound, molecule, biologic or moiety, (b) any polynucleotide or other genetic material that is directed to an Ophthalmology Target that is made available by AbbVie for use in the Ophthalmology Research Program or otherwise included by or on behalf of AbbVie in a Licensed Ophthalmology Product during the Term and any compound, molecule, biologic or moiety expressed thereby, and (c) any modifications, enhancements, improvements or derivatives of any of the foregoing.", "": "" }, { "Text": "1.8 \"Accounting Standards\" means, with respect to a Party or any of its Affiliates or its or their Sublicensees, United States generally accepted accounting principles, consistently applied.", "": "" }, { "Text": "1.9 \"Acquirer\" has the meaning set forth in the definition of Change of Control.", "": "" }, { "Text": "1.10 \"AD/PD Indication\" means, with respect to a product, an indication for the treatment, prevention, mitigation, cure of, or for the relief of symptoms associated with, Alzheimer's disease or Parkinson's disease.", "": "" }, { "Text": "1.11 \"Adaptive Trial\" means a Clinical Trial that does not meet the criteria for a Registrational Trial at the time such Clinical Trial is initiated and includes a prospectively planned opportunity for such Clinical Trial to be modified based on interim analyses to change to a Registrational Trial following an analysis of interim data from subjects in such Clinical Trial.", "": "" }, { "Text": "1.12 \"Additional Capsid Program Option Period\" means, with respect to each of α-syn and Tau, the time period commencing on AbbVie's exercise of the Initial Capsid Program Option with respect to α-syn or Tau, respectively, and ending the later of (a) sixty (60) days following the delivery by Capsida to AbbVie of the Final Data Package for Research Stage Two for α-syn or Tau, respectively and (b) fifty (50) days after AbbVie's receipt of such other information and Know-How (excluding any Highly Sensitive Know-How) in Capsida's Possession as AbbVie may reasonably request within fifteen (15) Business Days after its receipt of such Final Data Package that is reasonably necessary to inform its decision regarding whether to exercise the Additional Capsid Program Option for α-syn or Tau, respectively.", "": "" }, { "Text": "1.13 \"Affiliate\" means, with respect to a Party, any Person that, directly or indirectly, through one (1) or more intermediaries, controls, is controlled by or is under common control with such Party at any time for so long as such Person controls, is controlled by or is under common control with such Party. For purposes of this definition, \"control\" and, with correlative meanings, the terms \"controlled by\" and \"under common control with\" means: (a) the possession, directly or indirectly, of the power to direct the management or policies of a business entity, whether through the ownership of voting securities, by contract relating to voting rights or corporate governance or otherwise; or (b) the ownership, directly or indirectly, of more than fifty percent (50%) of the voting securities or other ownership interest of a business entity (or, with respect to a limited partnership or other similar entity, its general partner or controlling entity).", "": "" }, { "Text": "1.14 \"Allowable Expenses\" means, subject to the other provisions of this Agreement, the FTE Costs (charged in accordance with Section 9.15) and the Out-of-Pocket Costs that are specifically identifiable or reasonably allocable to the Commercialization of the ALS Product (including a Co-Promotion Product) in the Territory during the Profit Share Term for such ALS Product incurred by AbbVie or any of its Affiliates, including the following, or, solely pursuant to clause (j) (with respect to Patent Costs), Capsida or its Affiliates:", "": "" }, { "Text": "(a) Sales and Marketing Costs;", "": "" }, { "Text": "(b) Distribution Costs;", "": "" }, { "Text": "(c) Manufacturing Costs for an ALS Product (including any components thereof) Manufactured for sale or distribution in the Territory (including manufacturing start-up in advance of launch of the applicable ALS Product and Manufacturing of samples of the applicable ALS Product distributed for use in the Territory, inventory write-off, obsolescence and disposal), and, if applicable, subject to the terms of any commercial supply agreement between the Parties executed at the time the expense is incurred;", "": "" }, { "Text": "(d) Medical Affairs Costs;", "": "" }, { "Text": "(e) Costs associated with patient assistance programs in the Territory;", "": "" }, { "Text": "(f) Product liability insurance with respect to the ALS Products in the Territory in the event the Parties obtain a joint policy;", "": "" }, { "Text": "(g) Third Party Payments specifically identifiable or reasonably allocable to the ALS Products in the Territory;", "": "" }, { "Text": "(h) Costs associated with recall, withdrawal or field corrections of an ALS Product in the Territory, except to the extent such costs arise from either Party's (i) gross negligence, recklessness, willful misconduct or (ii) breach of this Agreement, the Co-Promotion Agreement, the clinical supply agreement entered into by the Parties pursuant to Section 5.2 or the quality agreement entered into by the Parties pursuant to Section 3.4.3;", "": "" }, { "Text": "(i) Losses specifically identifiable or reasonably allocable to the Commercialization of the ALS Product in the Territory, or the Manufacture of the ALS Product in support thereof, to the extent treated as Allowable Expenses pursuant to Section 13.3;", "": "" }, { "Text": "(j) Patent Costs and Trademark Costs to the extent related to the ALS Product in the Territory (to the extent not otherwise reimbursed through recoveries obtained in connection with any litigation or otherwise reimbursed as contemplated under Article 10 and, in the case of either Party, to the extent such Patent Costs do not arise as a result of or in connection with any breach by such Party of this Agreement); and", "": "" }, { "Text": "(k) Regulatory Expenses (except to the extent included in Development Costs);", "": "" }, { "Text": "in each case, to the extent not deducted from Net Sales of ALS Products in the Territory, and provided, that except as provided above, Allowable Expenses (i) shall exclude Development Costs, with respect to which Capsida shall bear its fifty percent (50%) share pursuant to Section 4.2.5(a) and (ii) shall be calculated in the case of any component of Allowable Expenses in accordance with the applicable definition thereof, Accounting Standards and the applicable terms of this Agreement and (iii) shall be allocated in accordance with such Party's customary allocation methodology consistently applied across its product portfolio.", "": "" }, { "Text": "1.15 \"ALS Product\" means a product containing a Collaboration Program Capsid and the ALS Cargo (including any such product that becomes a Licensed Product).", "": "" }, { "Text": "1.16 \"ALS Reversion Product\" means, with respect to an ALS Reversion Triggering Event, the ALS Product for which final individual Capsid-cargo characterization is conducted pursuant to Section 2.3.8 and a Final Data Package is delivered to AbbVie, in the forms, formulations and therapeutic regimens and for the uses that were under Research or Development at the time of such ALS Reversion Triggering Event.", "": "" }, { "Text": "1.17 \"ALS Reversion Triggering Event\" means (a) failure to exercise the Collaboration Program Option during the Collaboration Program Option Period other than for Good Reason, (b) termination of this Agreement by AbbVie pursuant to Section 14.2.2 with respect to the Collaboration Research Program other than for Good Reason, or (c) termination of this Agreement by Capsida pursuant to Section 14.2.1; provided, that in each case ((a)-(c)) all of the following conditions are also met: AbbVie has at the applicable time already exercised an Initial Capsid Program Option for either or both of α-syn or Tau and Capsida has completed the activities under the Collaboration Research Program and delivered a Final Data Package to AbbVie (whether for a Primary Capsid or Back-up Capsid) irrespective of whether the ALS Product that is the subject of final individual Capsid-cargo characterization conducted pursuant to Section 2.3.8 achieves the applicable Target Product Profile.", "": "" }, { "Text": "1.18 \"Applicable Law\" means applicable laws, rules and regulations, including any rules, regulations, guidelines or other requirements of Regulatory Authorities, that may be in effect from time to time, which, with respect to each Research, Development or Manufacturing activity that will or would reasonably be expected to be submitted to a Regulatory Authority in support of a Regulatory Approval Application or a Regulatory Approval, shall be deemed to include the applicable regulations and guidances of the FDA, the United Kingdom, and European Union (and national implementations thereof) that constitute good laboratory practices, cGMP and good clinical practices (and, if and as appropriate under the circumstances, International Conference on Harmonization (ICH) guidance or other comparable regulation and guidance of any applicable Regulatory Authority in the Territory).", "": "" }, { "Text": "1.19 \"Biosimilar Product\" means, with respect to a particular Licensed Product or a particular Licensed Ophthalmology Product, as applicable, in a particular country in the Territory, any pharmaceutical product that is claimed to be biosimilar to or interchangeable with such Licensed Product or such Licensed Ophthalmology Product, or that is the subject of an application submitted under Section 351(k) of the PHSA citing such Licensed Product or such Licensed Ophthalmology Product as the reference product or on an application referencing or relying on such Licensed Product or such Licensed Ophthalmology Product or its prior approval or marketing authorization, or any corresponding foreign application in the Territory, including, with respect to the European Union, a Marketing Authorization Application filed with the EMA pursuant to the centralized approval procedure or with the applicable Regulatory Authority of a country in Europe with respect to the mutual recognition procedure or any other national approval.", "": "" }, { "Text": "1.20 \"BLA\" means a Biologics License Application as described in 21 C.F.R. §601.2, or equivalent application in any applicable foreign jurisdiction in the Territory.", "": "" }, { "Text": "1.21 \"BPCI Act\" means the Biologics Price Competition and Innovation Act of 2009, as may be amended from time to time, together with any rules, regulations and requirements promulgated thereunder (including all additions, supplements, extensions and modifications thereto).", "": "" }, { "Text": "1.22 \"Business Day\" means a day other than a Saturday or Sunday or a day on which banking institutions in Chicago, Illinois or Los Angeles, California are permitted or required to be closed.", "": "" }, { "Text": "1.23 \"Calendar Quarter\" means each successive period of three (3) calendar months commencing on January 1, April 1, July 1 or October 1, except that the first Calendar Quarter of the Term shall commence on the Effective Date and end on the day immediately prior to the first to occur of January 1, April 1, July 1 or October 1 after the Effective Date and the last Calendar Quarter shall end on the last day of the Term.", "": "" }, { "Text": "1.24 \"Calendar Year\" means each successive period of twelve (12) calendar months commencing on January 1 and ending on December 31, except that the first Calendar Year of the Term shall commence on the Effective Date and end on December 31 of the year in which the Effective Date occurs and the last Calendar Year of the Term shall commence on January 1 of the year in which the Term ends and end on the last day of the Term.", "": "" }, { "Text": "1.25 \"CalTech License Agreement\" means the License Agreement between Capsida and the California Institute of Technology effective as of August 5, 2019 and as amended effective September 1, 2020.", "": "" }, { "Text": "1.26 \"Capsid\" means an engineered or naturally occurring adeno-associated virus (AAV)-based capsid protein or proteins (or the encoding nucleic acid sequence(s) thereof), that is capable of encapsulating one or more polynucleotides, whether single stranded (ss) or self-complementary (sc), and delivering such polynucleotide(s) to a desired tissue or action site. For purposes of this Agreement, Capsids that contain the same amino acid sequence shall be considered the same Capsid irrespective of any post-translational modifications or variations between such Capsids.", "": "" }, { "Text": "1.27 \"Capsid Program Capsid\" means any of the Capsids that AbbVie selects as Selected Capsids for α-syn or Tau pursuant to Section 2.3.8.", "": "" }, { "Text": "1.28 \"Capsid Program Option\" means the Initial Capsid Program Option and, if any, the Additional Capsid Program Option.", "": "" }, { "Text": "1.29 \"Capsid Program Option Period\" means the Initial Capsid Option Period(s) and, if any, the Additional Capsid Program Option Period.", "": "" }, { "Text": "1.30 \"Capsid Research Program\" means all activities to be conducted by the Parties under the Capsid Program Research Plan and, if applicable, the RP2 Plan.", "": "" }, { "Text": "1.31 \"Capsida Background IP\" means Capsida Background Know-How and Capsida Background Patents.", "": "" }, { "Text": "1.32 \"Capsida Background Know-How\" means all information (including regulatory data, Know-How relating to Manufacture of Capsids, files, approvals and other documentation) and other Know-How owned or Controlled by Capsida or any of its Affiliates (a) as of the Original Agreement Effective Date or (b) after the Original Agreement Effective Date and that was or is conceived, discovered, generated, created, developed, acquired or otherwise made outside of the Research Program, the POC Plan or the Ophthalmology Research Program, in each case ((a) and (b)) that is not generally known and is necessary or reasonably useful (i) with respect to the Research Program, for the conduct of the Research Program or the POC Plan in accordance with the applicable Plans or the Exploitation of the Licensed Products, or (ii) with respect to the Ophthalmology Research Program, for the conduct of the Ophthalmology Research Program in accordance with the Ophthalmology Research Plan or the Exploitation of Licensed Ophthalmology Products, in each case ((i) and (ii)), excluding Cargo Know-How and Program Know-How.", "": "" }, { "Text": "1.33 \"Capsida Background Patents\" means all Patents owned or Controlled by Capsida or any of its Affiliates and issued or filed (a) on or before the Original Agreement Effective Date or (b) after the Original Agreement Effective Date, in each case ((a) and (b)), that are necessary or reasonably useful (or, with respect to patent applications, would be necessary or reasonably useful if such patent applications were to issue as patents) (i) with respect to the Research Program, for the conduct of the Research Program or the POC Plan in accordance with the applicable Plans or the Exploitation of any Licensed Product in the Field in the Territory; or (ii) with respect to the Ophthalmology Research Program, for the conduct of the Ophthalmology Research Program in accordance with the Ophthalmology Research Plan or the Exploitation of any Licensed Ophthalmology Product in the Field in the Territory, in each case ((i) and (ii)), including the Existing NP Patents and Existing OP Patents that are not Capsida Platform Patents. Capsida Background Patents shall include Patents covering the Capsida Background Know-How and exclude any Cargo Patents and any Program Patents.", "": "" }, { "Text": "1.34 \"Capsida Managed Patents\" means Existing NP Patents or Existing OP Patents, as applicable, for which Capsida or any of its Affiliates has the first right to control Prosecution and Maintenance as of the Original Agreement Effective Date.", "": "" }, { "Text": "1.35 \"Capsida Platform\" means (a) Capsida's proprietary processes for the design and genetic engineering of Capsids to, among other things, (i) selectively deliver polynucleotides across the blood-brain barrier or to the central nervous system or to the spinal cord following delivery, (ii) express such polynucleotides in select brain or spinal cord regions for use in the Field and (iii) enhance delivery of polynucleotides to tissues of the eye following IVT, IC, or SCS administration and express such polynucleotides in select eye tissues for use in the Field, which processes, in each case ((i)-(iii)), include iterative Capsid engineering by high-throughput screening of variants directly in non-human primates and prioritizing variants for further assessment of indication-specific criteria with desired tissue tropism and de-targeting aimed at achieving low doses and improved efficacy-safety profiles in humans and (b) any modifications, enhancements, improvements or derivatives of any of the foregoing.", "": "" }, { "Text": "1.36 \"Capsida Platform IP\" means Capsida Platform Know-How and Capsida Platform Patents.", "": "" }, { "Text": "1.37 \"Capsida Platform Know-How\" means any Know-How specifically directed to the Capsida Platform and that is conceived, discovered, generated, created, developed or otherwise made by or on behalf of a Party or any of its Affiliates, either alone or jointly with the other Party or any of its Affiliates or any other Person, under the Research Program or the POC Plan or the Ophthalmology Research Program or otherwise owned or Controlled by Capsida or its Affiliates as of the Original Agreement Effective Date or the Effective Date or during the Term; provided, however, (a) Capsida Platform Know-How shall include any deselected Capsid as described in Article 2 or Article 2A, as applicable, and (b) Capsida Platform Know-How shall not include any Know-How that is specifically directed to (i) AbbVie Cargo or AbbVie Ophthalmology Cargo (whether or not in combination with a Capsid or another molecule(s) or the Capsida Platform), (ii) proteins, peptides or polynucleotides implicated in neurodegenerative diseases such as α-syn, Tau, or TDP-43 (or any target that is a component thereof), (iii) proteins, peptides or polynucleotides implicated in ophthalmological diseases (including the AbbVie Indications), including Ophthalmology Targets, (iv) one (1) or more Reserved Capsids or Reserved Ophthalmology Capsids (until such time as a Reserved Capsid or a Reserved Ophthalmology Capsid becomes a deselected Capsid as defined in Article 2 or Article 2A, as applicable), Selected Capsids, Selected Ophthalmology Capsids, Research Products, Ophthalmology Research Products, Licensed Capsids, Licensed Ophthalmology Capsids, Licensed Products or Licensed Ophthalmology Products or (v) the Exploitation of any of the foregoing; or (vi) any Cargo Know-How or Manufacturing Know-How.", "": "" }, { "Text": "1.38 \"Capsida Platform Patent\" means any Patents Controlled by Capsida or any of its Affiliates as of the Original Agreement Effective Date or the Effective Date or at any time during the Term that specifically claim Capsida Platform Know-How; provided, however, Capsida Platform Patents shall not include any Patent that specifically claims (a) AbbVie Cargo or AbbVie Ophthalmology Cargo (whether or not in combination with a capsid or another molecule(s)), (b) proteins, peptides or polynucleotides implicated in neurodegenerative diseases such as α-syn, Tau, or TDP-43 (or any target that is a component thereof), (c) proteins, peptides or polynucleotides implicated in ophthalmological diseases (including the AbbVie Indications), including Ophthalmology Targets, (d) one (1) or more Reserved Capsids or Reserved Ophthalmology Capsids (until such time as a Reserved Capsid or a Reserved Ophthalmology Capsid becomes a deselected Capsid as defined in Article 2 or Article 2A, as applicable), Selected Capsids, Selected Ophthalmology Capsids, Research Products, Ophthalmology Research Products, Licensed Capsids, Licensed Ophthalmology Capsids, Licensed Products or Licensed Ophthalmology Products, (e) the Exploitation of any of the foregoing or (f) Cargo Patents or Manufacturing Patents.", "": "" }, { "Text": "1.39 \"Capsida Sales\" means, with respect to the ALS Reversion Product for any period, the total amount billed or invoiced on sales of such ALS Reversion Product during such period by Capsida, its Affiliates, or Sublicensees in the Territory to Third Parties (including wholesalers and Distributors), in bona fide arm's length transactions, less the following deductions, and in each case related specifically to the ALS Reversion Product and actually allowed and taken by such Third Parties and not otherwise recovered by or reimbursed to Capsida, its Affiliates, or Sublicensees:", "": "" }, { "Text": "(a) trade, cash and quantity discounts;", "": "" }, { "Text": "(b) price reductions or rebates, retroactive or otherwise, imposed by, negotiated with or otherwise paid to governmental authorities or other payees;", "": "" }, { "Text": "(c) taxes on sales (such as sales, value added, or use taxes) to the extent added to the sale price and set forth separately as such in the total amount invoiced;", "": "" }, { "Text": "(d) amounts repaid or credited by reason of rejections, defects, return goods allowance, recalls or returns, or because of retroactive price reductions, including rebates or wholesaler charge backs;", "": "" }, { "Text": "(e) the portion of administrative fees paid during the relevant time period to group purchasing organizations, pharmaceutical benefit managers or Medicare Prescription Drug Plans relating to such ALS Reversion Product;", "": "" }, { "Text": "(f) any consideration actually paid or payable by Capsida, its Affiliates or their respective Sublicensees for any Delivery System related to a billed or invoiced sale of such ALS Reversion Product, where for purposes of this Capsida Sales definition, a \"Delivery System\" means any delivery system comprising equipment, instrumentation, one (1) or more devices, or other mechanical components (such as a syringe or infusion bag) designed to assist in the administration of such ALS Reversion Product;", "": "" }, { "Text": "(g) any invoiced amounts from a prior period which are not collected and are written off by Capsida, its Affiliates or Sublicensees, including bad debts;", "": "" }, { "Text": "(h) that portion of the annual fee on prescription drug manufacturers imposed by the Patient Protection and Affordable Care Act, Pub. L. No. 111-148 (as amended) to the extent reasonably allocable to sales of such ALS Reversion Product;", "": "" }, { "Text": "(i) freight, insurance, import/export, and other transportation charges to the extent added to the sale price and set forth separately as such in the total amount invoiced, as well as any fees for services provided by wholesalers and warehousing chains related to the distribution of such ALS Reversion Product; and", "": "" }, { "Text": "(j) any other similar and customary deductions that are consistent with Accounting Standards, but which are not duplicative of the above deductions.", "": "" }, { "Text": "Capsida Sales shall not include transfers or dispositions for charitable, promotional, pre-clinical, clinical or regulatory purposes. Capsida Sales shall include the amount or fair market value of all other consideration received by Capsida, its Affiliates or Sublicensees in respect of such ALS Reversion Product, whether such consideration is in cash, payment in kind, exchange or other form. Capsida Sales shall not include sales between or among Capsida, its Affiliates, or Sublicensees.", "": "" }, { "Text": "Subject to the above, Capsida Sales shall be calculated in accordance with the standard internal policies and procedures of Capsida, its Affiliates or its or their Sublicensees, which must be in accordance with Accounting Standards.", "": "" }, { "Text": "For purposes of calculating Capsida Sales, all Capsida Sales shall be converted into Dollars in accordance with Section 9.17.", "": "" }, { "Text": "In the event the ALS Reversion Product is a Combination Product, the Capsida Sales for such Combination Product shall be calculated as follows:", "": "" }, { "Text": "(i) If Capsida, its Affiliate, or Sublicensee separately sells in such country or other jurisdiction (A) a Mono Product and (B) gene therapy products containing as their sole active ingredients the other active moiety(ies) in such Combination Product, the Capsida Sales attributable to such Combination Product shall be calculated by multiplying actual Capsida Sales of such Combination Product by the fraction A/(A+B) where: \"A\" is Capsida's (or its Affiliate's or Sublicensee's, as applicable) average Capsida Sales price during the period to which the Capsida Sales calculation applies for the Mono Product in such country or other jurisdiction and \"B\" is Capsida's (or its Affiliate's or Sublicensee's, as applicable) average Capsida Sales price during the period to which the Capsida Sales calculation applies in such country or other jurisdiction, for gene therapy products that contain as their sole active ingredients the other active moiety(ies) in such Combination Product.", "": "" }, { "Text": "(ii) If Capsida, its Affiliates, and Sublicensees do not separately sell in such country or other jurisdiction both the Mono Product and gene therapy products containing the other active moiety(ies) in such Combination Product, the Capsida Sales attributable to such Combination Product shall be determined by the Parties in good faith based on the relative fair market value of such Mono Product and such other active moiety(ies). If the Parties cannot agree on such relative value, the Dispute shall be resolved pursuant to Section 15.6.", "": "" }, { "Text": "1.40 \"Cargo IP\" means Cargo Know-How and Cargo Patents.", "": "" }, { "Text": "1.41 \"Cargo Know-How\" means any Know-How that is specifically directed to any (a) AbbVie platform for the generation of AbbVie Cargo or AbbVie Ophthalmology Cargo, (b) AbbVie Cargo, AbbVie Ophthalmology Cargo or Exploitation thereof (subject to the last sentence of this definition), (c) α-syn, Tau, or TDP-43 (or any target that is component of the foregoing) or any Selected Ophthalmology Target, (d) any (i) physical administration of Licensed Ophthalmology Products, including any devices used in connection therewith or (ii) formulation for ophthalmology-specific routes of administration, including for use with devices, or (e) other proprietary information, materials or technology (including regulatory data, Know-How relating to Manufacture of AbbVie Cargo, AbbVie Ophthalmology Cargo, files, approvals and other documentation) that is made available by AbbVie, and in each case ((a), (b), (c), (d) and (e)), that is conceived, discovered, generated, created, developed or otherwise made by or on behalf of a Party or any of its Affiliates, alone or jointly with the other Party or any of its Affiliates or any other Person, under or in connection with this Agreement or otherwise owned or Controlled by AbbVie or its Affiliates during the Term, including any such Know-How that relates to the use of AbbVie Cargo or AbbVie Ophthalmology Cargo in viral vectors, the expression of AbbVie Cargo or AbbVie Ophthalmology Cargo in particular cell types (through the use of promoters, enhancers or other viral vector modifications but not such promoters, enhancers or other post-transcriptional regulatory elements themselves) for diagnostic or therapeutic effect, the optimal binding regions of AbbVie Cargo or AbbVie Ophthalmology Cargo (for expression in viral vectors or otherwise), any change to the sequence of AbbVie Cargo or AbbVie Ophthalmology Cargo or the Manufacturing of any AbbVie Cargo or AbbVie Ophthalmology Cargo; provided, however, Cargo Know-How shall not include any Know-How that is specifically directed to (w) the Capsida Platform (whether or not in combination with AbbVie Cargo, AbbVie Ophthalmology Cargo or another molecule(s)), (x) one (1) or more Licensed Products, (y) one (1) or more Licensed Ophthalmology Products or (z) the Exploitation of any of the foregoing. Cargo Know-How shall not include any Capsida Platform Know-How or Manufacturing Know-How.", "": "" }, { "Text": "1.42 \"Cargo Patent\" means any Patent that specifically claims Cargo Know-How. Cargo Patents shall not include any Patent that specifically claims (a) the Capsida Platform (whether or not in combination with AbbVie Cargo, the AbbVie Ophthalmology Cargo or another molecule(s)), (b) one (1) or more Licensed Products, (c) one (1) or more Licensed Ophthalmology Products or (d) the Exploitation of any of the foregoing. Cargo Patents shall not include any Capsida Platform Patents or Manufacturing Patents.", "": "" }, { "Text": "1.43 \"cGMP\" means the current Good Manufacturing Practices as provided for (and as amended from time to time) in the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Harmonized Tripartite Guideline, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, Q7 (ICH Q7), the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use in Volume 4 of the European Commission's Rules governing medicinal products in the European Union and any analogous guidelines in the United Kingdom, and the United States Code of Federal Regulations 21 C.F.R. Parts 210 and 211, in each case, as applicable.", "": "" }, { "Text": "1.44 \"Change of Control\" means, with respect to a Party (a) the acquisition of beneficial ownership, directly or indirectly, by any Third Party of securities or other voting interest of such Party (or, if applicable, a parent of such Party) representing a majority or more of the combined voting power of such Party's (or, if applicable, a parent of such Party) then outstanding securities or other voting interests, (b) any merger, reorganization, consolidation or business combination involving such Party (or, if applicable, a parent of such Party) with a Third Party that results in the holders of beneficial ownership of the voting securities or other voting interests of such Party (or, if applicable, a parent of such Party) immediately prior to such merger, reorganization, consolidation or business combination ceasing to hold beneficial ownership of more than fifty percent (50%) of the combined voting power of the surviving entity immediately after such merger, reorganization, consolidation or business combination, or (c) any sale, lease, exchange, contribution or other transfer to a Third Party (in one transaction or a series of related transactions) of all or substantially all of the consolidated assets of such Party to which this Agreement relates. The acquiring or combining Third Party in any of clause (a), (b) or (c), is referred to herein as the \"Acquirer\".", "": "" }, { "Text": "1.45 \"Clinical Trial\" means any human clinical trial of a Licensed Product or of a Licensed Ophthalmology Product.", "": "" }, { "Text": "1.46 \"CMC Activities\" means the chemistry, manufacturing and controls activities required or otherwise conducted under or in connection with the Agreement.", "": "" }, { "Text": "1.47 \"Co-Promotion Option Period\" means, with respect to an ALS Product, the ninety (90)-day period commencing upon delivery by AbbVie of notice of the anticipated submission date for a BLA for such ALS Product in the United States pursuant to Section 6.3.3, during which period Capsida shall have the right to exercise the Co-Promotion Option with respect to such ALS Product.", "": "" }, { "Text": "1.48 \"Collaboration Program Capsid\" means any of the Capsids that AbbVie selects as Selected Capsids for TDP-43 pursuant to Section 2.3.8.", "": "" }, { "Text": "1.49 \"Collaboration Program Option Period\" means the time period commencing on the Effective Date and ending the later of (a) sixty (60) days following delivery by Capsida to AbbVie of the Final Data Package for the Collaboration Program Research Plan and (b) fifty (50) days after AbbVie's receipt of such other information and Know-How (excluding any Highly Sensitive Know-How) in Capsida's Possession as AbbVie may reasonably request within fifteen (15) Business Days after its receipt of such Final Data Package that is reasonably necessary to inform its decision regarding whether to exercise the Collaboration Program Option.", "": "" }, { "Text": "1.50 \"Collaboration Research Program\" means all activities to be conducted by the Parties under the Collaboration Program Research Plan.", "": "" }, { "Text": "1.51 \"Combination Product\" means (a) a Licensed Product that is sold with one (1) or more other active moieties in addition to the applicable Licensed Capsid and any AbbVie Cargo, or (b) a Licensed Ophthalmology Product that is sold with one (1) or more other active moieties in addition to the applicable Licensed Ophthalmology Capsid and any AbbVie Ophthalmology Cargo, in each case ((a) and (b)), either as a fixed dose/unit or as separate doses/units in a single package for a single price.", "": "" }, { "Text": "1.52 \"Commercialization\" means any and all activities related to the preparation for sale of, offering for sale of or sale of a Licensed Product or a Licensed Ophthalmology Product, including activities related to marketing, promoting, distributing and importing such Licensed Product or Licensed Ophthalmology Product, and interacting with Regulatory Authorities regarding any of the foregoing. When used as a verb, \"to Commercialize\" and \"Commercializing\" mean to engage in Commercialization and \"Commercialized\" has a corresponding meaning.", "": "" }, { "Text": "1.53 \"Commercially Reasonable Efforts\" means (a) with respect to the efforts and resources to be expended, or considerations to be undertaken, by AbbVie with respect to any objective, activity or decision to be undertaken with respect to the Research, Development, Manufacture or Commercialization of a Licensed Product or a Licensed Ophthalmology Product, the reasonable efforts and resources to accomplish such objective, activity or decision that would be comparable with the efforts and resources that AbbVie and its Affiliates would normally use in the exercise of its reasonable business discretion to accomplish a similar objective, activity or decision; it being understood and agreed that with respect to the Research, Development, Manufacture or Commercialization of a Licensed Product or a Licensed Ophthalmology Product, such efforts and resources shall be consistent with those efforts and resources commonly used by AbbVie and its Affiliates under similar circumstances with respect to a compound or product controlled by it, which compound or product is at a similar stage in its development or product life, is in a similar therapeutic and disease area and is of similar market potential taking into account: (i) expected and actual issues of efficacy, safety and manufacturing, and expected and actual approved labeling, including the discovery of unanticipated toxicity or any material adverse event or condition relating to the safety or efficacy of such Licensed Product or such Licensed Ophthalmology Product; (ii) the expected and actual competitiveness of alternative products (including generic or biosimilar products) under development or sold in the marketplace; (iii) adverse changes in the market conditions that affect the market potential of such Licensed Product or such Licensed Ophthalmology Product generally or any particular indication of such Licensed Product or such Licensed Ophthalmology Product; (iv) the expected and actual profile of such Licensed Product or such Licensed Ophthalmology Product, taking into account the results of, including the existence of failed or inconclusive, clinical studies; (v) the nature and extent of expected and actual market exclusivity (including patent coverage, regulatory and other exclusivity) of such Licensed Product or such Licensed Ophthalmology Product; (vi) the likelihood and expected scope of Regulatory Approval given the regulatory structure involved, including regulatory or data exclusivity and pricing and reimbursement approval by governmental and private payors, including formulary positioning; (vii) changes in clinical or regulatory strategy justified by compliance with the requirements of regulatory feedback from any Regulatory Authority; (viii) the expected and actual profitability and return on investment of such Licensed Product or such Licensed Ophthalmology Product; and (ix) other relevant factors, including legal, medical, scientific, technical and commercial factors; and (b) with respect to the efforts and resources to be expended, or considerations to be undertaken, by Capsida with respect to any objective, activity or decision under the Research Program or the Ophthalmology Research Program, as applicable, or the Research, Development or Manufacturing of a Program Capsid, Capsid Program Capsid, Collaboration Program Capsid, Ophthalmology Program Capsid, Reserved Capsid, Selected Capsid, Research Product, Licensed Capsid, Licensed Product, Reserved Ophthalmology Capsid, Selected Ophthalmology Capsid, Ophthalmology Research Product, Licensed Ophthalmology Capsid, Licensed Ophthalmology Product or, if applicable, the ALS Reversion Product, such reasonable and good faith efforts and resources to accomplish such objective, activity or decision that would be comparable with the efforts and resources Capsida and its Affiliates would normally use in the exercise of its reasonable business discretion (but in no event less than the efforts that would normally be used by a company in the biotechnology industry of comparable size and resources to Capsida and its Affiliates) for research and development of novel biopharmaceutical products at a similar stage in development, but in no event less than the efforts and resources used by Capsida and its Affiliates for any of its solely owned products. In addition, (x) with regard to AbbVie's obligations relating to the Research, Development and Commercialization of Licensed Product(s) or Licensed Ophthalmology Product(s) hereunder, \"Commercially Reasonable Efforts\" shall be determined on a country-by-country or market-by-market basis (as most applicable) for a particular product, and it is anticipated that the level of effort will change over time, including to reflect changes in the status of the product and the countries (or markets) involved and (y) with regard to Capsida's obligations relating to the Research Program or the Ophthalmology Research Program, in determining whether Capsida has used \"Commercially Reasonable Efforts\", no overrun with respect to the amounts set forth in the budget included in a Research Plan or in the Ophthalmology Research Plan shall be a factor weighed (that is, Capsida may not apply lesser resources or efforts in support of any objective, activity or decision under the Research Program or the Ophthalmology Research Program because it would result in an overrun of the budget in a Research Plan or the Ophthalmology Research Plan).", "": "" }, { "Text": "1.54 \"Control\" means, with respect to any item of Know-How, Regulatory Documentation, material, Patent or other intellectual property right, possession of the right, whether directly or indirectly and whether by ownership, license or otherwise (other than by operation of the license and other grants in Section 8.1 or Section 8.2), to grant a license, sublicense or other right (including the right to reference Regulatory Documentation) to or under such Know-How, Regulatory Documentation, material, Patent or other intellectual property right as provided for herein without violating the terms of any agreement with any Third Party.", "": "" }, { "Text": "1.55 \"Converted Trial\" means an Adaptive Trial that is modified to meet and otherwise satisfies the criteria for a Registrational Trial based on pre-specified analyses following an analysis of interim data from subjects in such Adaptive Trial. For clarity, an Adaptive Trial shall only constitute a Converted Trial if, from and after the date following such modification or analysis, such Adaptive Trial is continued as a Registrational Trial (such date with respect to such Converted Trial, the \"Conversion Date\").", "": "" }, { "Text": "1.56 \"Corporate Names\" means the Trademarks and logos identified on Schedule 1.56 and such other names and logos as Capsida may designate in writing from time to time.", "": "" }, { "Text": "1.57 \"CPI\" means (a) with respect to FTEs in the United States the Consumer Price Index – All Urban Consumers, 1982-84=100, by the United States Department of Labor, Bureau of Statistics (or its successor equivalent index), or (b) an equivalent index in a foreign country applicable to FTEs in such country, accounting if possible for the area in such country where the personnel are located.", "": "" }, { "Text": "1.58 \"CPI Adjustment\" means the percentage increase or decrease, if any, in the CPI applicable to such personnel for the twelve (12) months ending June 30 of the Calendar Year prior to the Calendar Year for which the adjustment is being made.", "": "" }, { "Text": "1.59 \"dAMD\" means dry age-related macular degeneration of early, intermediate or advanced classification.", "": "" }, { "Text": "1.60 \"Data Package\" means, with respect to an activity pursuant to the applicable Plan, upon the completion of such activity, the delivery of (a) a data package that includes the Results (excluding raw sequence data except for Selected Capsids or Selected Ophthalmology Capsids, as applicable) from such activity and (b) such other information, Know-How and materials as may be required pursuant to, and in the amount or form and meeting the specifications, as applicable, set forth in, the applicable Plan.", "": "" }, { "Text": "1.61 \"Data Protection Laws\" means any law, statute, declaration, decree, directive, legislative enactment, order, ordinance, regulation, rule or other binding restriction (as amended, consolidated or re-enacted from time to time) which relates to the protection of individuals with regards to the Processing of Personal Data to which a Party is subject.", "": "" }, { "Text": "1.62 \"Detail\" means, with respect to a Co-Promotion Product in the United States, a contact between a sales representative and a physician or other medical professional licensed to prescribe drugs, as will be further defined in the Co-Promotion Agreement and as measured by each Party's internal recording of such activity in accordance with the Co-Promotion Agreement. When used as a verb, \"Detail\" means to engage in a Detail.", "": "" }, { "Text": "1.63 \"Development\" means any research and development activities, including, as applicable, biodistribution and transduction studies and tissue distribution across species, translational (target engagement, biomarker) studies, toxicology and tolerability studies, additional pharmacology (efficacy) studies, statistical analysis and report writing, formulation, formulation development and optimization, process development, methods development, clinical trials, regulatory affairs (including preparation for a Regulatory Approval Application submission and other submission-related activities), product approval and registration activities, Manufacturing (including validation activities) in support of the foregoing, and all other activities necessary to conduct IND-enabling studies or seek, obtain and maintain Regulatory Approval. \"Development\" shall not include Research or Commercialization, but may include Manufacturing to the extent applicable to the activities described in the preceding sentence.", "": "" }, { "Text": "1.64 \"Development Costs\" means the FTE Costs (charged in accordance with Section 9.15) and the Out-of-Pocket Costs incurred by or on behalf of AbbVie or any of its Affiliates, or by Capsida or any of its Affiliates that are specifically identifiable or reasonably allocable to Development activities with respect to any ALS Product during the Profit Share Term and allocated in accordance with such Party's customary allocation methodology consistently applied across its product portfolio, including regulatory activities in connection therewith, but excluding in all cases (x) any activities performed by Capsida under or in connection with the POC Plan (including the costs and expenses associated with any ongoing monitoring and patient follow-up activities with respect to Clinical Trials conducted under the POC Plan) and (y) Regulatory Expenses, calculated in accordance with Accounting Standards other than as expressly listed below. Subject to the foregoing, Development Costs shall include such costs in connection with the following activities, as applicable:", "": "" }, { "Text": "(a) pre-clinical and non-clinical activities such as biodistribution, toxicology and formulation development, test method development, stability testing, quality assurance, quality control development and statistical analysis;", "": "" }, { "Text": "(b) Clinical Trials (including aspects of such Clinical Trials involving any comparator product or co-administered agent), including (i) the preparation for and conduct of clinical studies including follow-up and long-term extension studies as required for gene therapy products by Regulatory Authorities or Applicable Law; (ii) data collection and analysis and report writing; (iii) clinical laboratory work; and (iv) regulatory activities in direct connection with such studies, including obtaining and maintaining INDs, adverse event recordation and reporting and other Regulatory Filings;", "": "" }, { "Text": "(c) the preparation of a regulatory dossier to support obtaining or maintaining any Regulatory Approval (including any label expansion) for any Licensed Product in the Territory, but excluding the preparation of any Regulatory Approval Application and any filing fees in connection with the filing of applications for any Regulatory Approval;", "": "" }, { "Text": "(d) (i) Manufacturing Costs for any ALS Product for use in clinical studies or other Development activities for such ALS Product; (ii) the manufacture, purchase or packaging of comparator products, co administered agents or placebos for use in clinical studies for any ALS Product (with the manufacturing costs for comparator products, co-administered agents or placebos to be determined in the same manner as Manufacturing Costs are determined for such ALS Product); and (iii) costs and expenses of disposal of drugs and other supplies used in such clinical studies or other Development activities, in each case unless otherwise agreed by the Parties in a supply agreement;", "": "" }, { "Text": "(e) Costs for the development of the Manufacturing process for an ALS Product, scale-up, manufacturing process validation, including validation batches, manufacturing improvements, and qualification and validation of Third Party contract manufacturers, in each case unless otherwise agreed by the Parties in a supply agreement; and", "": "" }, { "Text": "(f) Costs associated with recall, withdrawal or field corrections of an ALS Product in connection with the Development of such ALS Product, except to the extent such costs arise from either Party's (i) gross negligence, recklessness, willful misconduct or (ii) breach of this Agreement, the Co-Promotion Agreement, the clinical supply agreement entered into by the Parties pursuant to Section 5.2 or the quality agreement entered into by the Parties pursuant to Section 3.4.3.", "": "" }, { "Text": "1.65 \"Distributor\" means any Person appointed by AbbVie or Capsida, as applicable, or any of its Affiliates or its or their Sublicensees to distribute, market and sell Licensed Product, Licensed Ophthalmology Product or the ALS Reversion Product, as applicable, with or without packaging rights, in one or more countries in the Territory, in circumstances where such Person purchases its requirements of Licensed Product or Licensed Ophthalmology Product from AbbVie or its Affiliates or its or their Sublicensees or ALS Reversion Product from Capsida or its Affiliates or its or their Sublicensees, as applicable, but does not otherwise make any royalty or other payment to AbbVie or Capsida, as applicable, or its Affiliates or its or their Sublicensees with respect to its intellectual property rights with respect to, or that is based on sales of, such Licensed Product, Licensed Ophthalmology Product or ALS Reversion Product.", "": "" }, { "Text": "1.66 \"Distribution Costs\" means, to the extent not included in Manufacturing Costs, the FTE Costs (charged in accordance with Section 9.15) incurred, and the direct Out-of-Pocket Costs incurred by AbbVie or any of its respective Affiliates during the Term and pursuant to this Agreement that are specifically identifiable or reasonably allocable to the commercial distribution of an ALS Product to a Third Party in the Territory during the Profit Share Term, and calculated in accordance with Accounting Standards, including:", "": "" }, { "Text": "(a) handling and transportation to fulfill orders (excluding such costs, if any, treated as a deduction in the definition of Net Sales);", "": "" }, { "Text": "(b) customer services, including order entry, billing and adjustments, inquiry and credit and collection; and", "": "" }, { "Text": "(c) direct costs of storage and distribution of such ALS Product.", "": "" }, { "Text": "The Parties may, if appropriate, agree in writing that Distribution Costs be determined on the basis of a specified annual charge or as a percentage of Net Sales.", "": "" }, { "Text": "1.67 \"DME\" means diabetic macular edema.", "": "" }, { "Text": "1.68 \"DOJ\" has the meaning set forth in the definition of \"HSR Filing\".", "": "" }, { "Text": "1.69 \"Dollars\" or \"$\" means United States Dollars.", "": "" }, { "Text": "1.70 \"DR\" means diabetic retinopathy inclusive of background diabetic retinopathy and proliferative diabetic retinopathy.", "": "" }, { "Text": "1.71 \"EEA\" means the European Economic Area.", "": "" }, { "Text": "1.72 \"EMA\" means the European Medicines Agency and any successor agency thereto.", "": "" }, { "Text": "1.73 \"European Union\" means the economic, scientific and political organization of member states as it may be constituted from time to time.", "": "" }, { "Text": "1.74 \"Exercise Notice\" means written notice by AbbVie to Capsida exercising any Initial Capsid Program Option, the Additional Capsid Program Option, the Collaboration Program Option or any Ophthalmology Program Option.", "": "" }, { "Text": "1.75 \"Existing Capsids\" means the Capsids set forth on Schedule 1.75.", "": "" }, { "Text": "1.76 \"Existing In-License Agreement\" means any license or other agreement between Capsida or any of its Affiliates, on the one hand, and a Third Party, on the other hand, existing as of the Original Agreement Effective Date regarding any Third Party intellectual property rights licensed to AbbVie hereunder, including those in-license agreements set forth on Schedule 12.2.1. For purposes of Section 12.2 and Section 12.3, Existing In-License Agreements shall not include any license or other agreement that was not disclosed to AbbVie at least ten (10) Business Days prior to the Original Agreement Effective Date.", "": "" }, { "Text": "1.77 \"Exploit\" means to make, have made, import, use, sell or offer for sale, including to Research, Develop, Commercialize, register, modify, enhance, improve, Manufacture, have Manufactured, hold or keep (whether for disposal or otherwise), formulate, optimize, have used, export, transport, distribute, promote, market or have sold or otherwise dispose of. \"Exploitation\" means the act of Exploiting a compound, product or process.", "": "" }, { "Text": "1.78 \"Expression Elements\" means (a) a gene expression cassette comprising one or more regulatory elements associated with the targeting, transduction or expression of a protein, peptide or polynucleotide, which may include one (1) or more promoters, enhancers, introns, or other transcriptional or post-transcriptional regulatory elements and may further include a peptide encoding sequence directed to an in vivo selection marker, but excluding the AbbVie Cargo, or (b) any portion of such gene expression cassette.", "": "" }, { "Text": "1.79 \"FDA\" means the United States Food and Drug Administration and any successor agency thereto.", "": "" }, { "Text": "1.80 \"FFDCA\" means the United States Federal Food, Drug, and Cosmetic Act, as set forth at 21 U.S.C. ch. 9 §301 et seq., as may be amended from time to time, together with any rules, regulations and requirements promulgated thereunder (including all additions, supplements, extensions and modifications thereto).", "": "" }, { "Text": "1.81 \"Field\" means all human and non-human diagnostic, prophylactic and therapeutic uses.", "": "" }, { "Text": "1.82 \"Final Data Package\" means, with respect to each Research Stage and each Target that is included in such Research Stage, upon completion of the Research Program and the associated CMC Activities and either: (i) the JGC's determination that a Research Product from such Research Stage directed to such Target meets the applicable Target Product Profile, or (ii) as otherwise agreed by the JGC, the delivery of (a) the Results from the Research Program for such Research Product and the Selected Capsids for such Target for such Research Stage and any other Selected Capsid for which Capsida has previously delivered a Final Data Package but for which AbbVie has not yet exercised its Option and (b) such other information, Know-How and materials as may be required pursuant to, and in the amount or form and meeting the specifications, as applicable, set forth in, the applicable Plan.", "": "" }, { "Text": "1.83 \"Final Ophthalmology Data Package\" means, with respect to each Route of Administration, upon completion of the Ophthalmology Research Plan for such Route of Administration and the applicable activities thereunder (including completion resulting from the expiration of the seventy-five (75) month period in clause (c)(ii) of the definition of \"Screening Period\") and either (a) the JGC's determination that an Ophthalmology Program Capsid for such Route of Administration meets the applicable Ophthalmology Target Capsid Profile or (b) as otherwise agreed by the JGC, the delivery of (i) a data package that includes all data specified in the applicable section of the Ophthalmology Research Plan for such Route of Administration, and all other Results generated from the Ophthalmology Research Program as set forth in the Ophthalmology Research Plan for such Ophthalmology Program Capsid and any other Selected Ophthalmology Capsid for which Capsida has previously delivered a Final Ophthalmology Data Package but for which AbbVie has not yet exercised its applicable Ophthalmology Program Option, and (ii) such other information, Know-How, and materials as may be required pursuant to, and in the amount or form and meeting the specifications, as applicable, set forth in, the Ophthalmology Research Plan.", "": "" }, { "Text": "1.84 \"First Commercial Sale\" means, with respect to a (a) Licensed Product or ALS Reversion Product and a country, the first sale for monetary value of such Licensed Product or ALS Reversion Product, as applicable, in such country by AbbVie, its Affiliates or its or their Sublicensees to a Third Party after all Regulatory Approvals (other than pricing and reimbursement approval) for such Licensed Product or ALS Reversion Product have been obtained in such country and (b) Licensed Ophthalmology Product and a country, the first sale for monetary value of such Licensed Ophthalmology Product in such country by AbbVie, its Affiliates or its or their Sublicensees to a Third Party after all Regulatory Approvals, including pricing and reimbursement approvals, for such Licensed Ophthalmology Product have been obtained in such country. Sales prior to receipt of all Regulatory Approvals for such Licensed Product or ALS Reversion Product or Licensed Ophthalmology Product in such country, such as so-called \"treatment IND sales,\" \"named patient sales,\" and \"compassionate use sales,\" shall not be construed as a First Commercial Sale.", "": "" }, { "Text": "1.85 \"FTC\" has the meaning set forth in the definition of \"HSR Filing\".", "": "" }, { "Text": "1.86 \"FTE\" means the equivalent of the work of one (1) employee full time for one (1) Calendar Year (consisting of at least a total of one thousand eight hundred (1800) hours per Calendar Year) of work performing applicable Exploitation activities. Any person who devotes less than one thousand eight hundred (1800) hours per Calendar Year (or such other number as may be agreed by the JGC, as applicable) shall be treated as an FTE on a pro rata basis based upon the actual number of hours worked divided by one thousand eight hundred (1800).", "": "" }, { "Text": "1.87 \"FTE Costs\" means, with respect to a Party and an activity for any period, the applicable FTE Rate multiplied by the applicable number of FTEs of such Party performing such activity during such period.", "": "" }, { "Text": "1.88 \"FTE Rate\" means the applicable rate(s) set forth on Schedule 1.88, such rates to be adjusted annually (with the first of such adjustments to be made as of January 1, 2022 and each subsequent Calendar Year thereafter, but such adjustment determined no later than the preceding September 30) with respect to the FTEs in a particular location, by the applicable CPI Adjustment, which represents the fully burdened rate for such FTE and includes all Included FTE Costs and Expenses for such FTE.", "": "" }, { "Text": "1.89 \"Future Capsida In-License Agreement\" means any license or other agreement between Capsida or any of its Affiliates, on the one hand, and a Third Party, on the other hand, that after the Effective Date is entered into pursuant to (a) Section 8.4.2(a)(i) or (b) Section 8.4.2(b) only from and after the date that such license or other agreement is consistent with the terms and conditions of this Agreement in all material respects (or the date on which AbbVie agrees to such license or other agreement in writing).", "": "" }, { "Text": "1.90 \"GA\" means geographic atrophy secondary to age-related macular degeneration.", "": "" }, { "Text": "1.91 \"Glaucoma\" means open-angle, angle-closure glaucoma, high tension glaucoma, normal-tension glaucoma, secondary glaucoma, pigmentary glaucoma, neovascular glaucoma, childhood glaucoma, pseudoexfoliation syndrome, and irido corneal endothelial syndrome.", "": "" }, { "Text": "1.92 \"Good Reason\" means, with respect to a decision by AbbVie to not exercise the Collaboration Program Option or to terminate the Agreement with respect to the Collaboration Research Program or the ALS Product, that such decision was based on AbbVie's bona fide, good faith determination in accordance with AbbVie's standard policies and procedures, that the applicable Research Product(s) or the ALS Product, as applicable, (a) would not reasonably be expected to exhibit a therapeutic index acceptable to proceed to IND-enabling studies after good faith consideration of Capsida's scientific input and objective evidence or (b) cannot be safely Developed or Commercialized for human use in the Field for which such Licensed Product is reasonably likely to be efficacious.", "": "" }, { "Text": "1.93 \"Government Official\" means (a) any Person employed by or acting on behalf of a government, government-controlled agency or entity or public international organization, (b) any political party, party official or candidate, (c) any Person who holds or performs the duties of an appointment, office or position created by custom or convention or (d) any Person who holds himself out to be the authorized intermediary of any of the foregoing.", "": "" }, { "Text": "1.94 \"Highly Sensitive Know-How\" means, to the extent not generally in the public domain (e.g., via publications, patents), (a) Capsida's proprietary processes for the design and genetic engineering of Capsids to, among other things, selectively deliver polynucleotides across the blood-brain barrier or to the central nervous system or to the spinal cord following delivery and express such polynucleotides in select brain or spinal cord regions, or enhance delivery of polynucleotides to tissues of the eye following IVT, IC, or SCS administration, which processes include iterative Capsid engineering by high-throughput screening of variants directly in non-human primates and in connection with the Ophthalmology Research Program, potentially other animals as contemplated in the Ophthalmology Research Plan, and (b) general Manufacturing process development or steps for generation of Capsids that are not specifically related to a Research Product Candidate, Research Product, Ophthalmology Research Product, Licensed Capsid, Licensed Ophthalmology Capsid, Licensed Product or Licensed Ophthalmology Product. For clarity, Highly Sensitive Know-How, does not include (1) the output of such proprietary processes for example, scientific data or results related to the evolution of capsids or capsids families, factors that govern tropism, immunogenicity, and other aspects of the Target Capsid Profile or (2) selection methodology for how Capsids are prioritized.", "": "" }, { "Text": "1.95 \"HSR Act\" means the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as codified at 15 U.S.C. §18a, as may be amended from time to time, and the rules and regulations promulgated thereunder, or foreign equivalent thereof under Applicable Law (including all additions, supplements, extensions and modifications thereto).", "": "" }, { "Text": "1.96 \"HSR Clearance\" means, with respect to this Agreement, the expiration or termination of all applicable waiting periods and requests for information (and any extensions thereof) under the HSR Act.", "": "" }, { "Text": "1.97 \"HSR Filing\" means (a) filings by Capsida and AbbVie with the United States Federal Trade Commission (the \"FTC\") and the Antitrust Division of the United States Department of Justice (the \"DOJ\") of a Notification and Report Form for Certain Mergers and Acquisitions (as that term is defined in the HSR Act) with respect to the matters set forth in this Agreement, together with all required documentary attachments thereto, or (b) equivalent filings, if any, with applicable governmental authorities where such filings are required.", "": "" }, { "Text": "1.98 \"IC\" means intracameral administration.", "": "" }, { "Text": "1.99 \"In-License Agreement\" means any Existing In-License Agreement and any Future Capsida In-License Agreement, in each case, as amended from time to time to the extent permitted under this Agreement.", "": "" }, { "Text": "1.100 \"Included FTE Costs and Expenses\" means the sum of (a) all costs and expenses for the employee performing any Research, Development or Manufacturing, as applicable, activities hereunder, including salaries, wages, bonuses, commissions, benefits, profit sharing, stock option grants, FICA costs and other similar ex-U.S. costs, travel, meals and entertainment, training, recruiting, relocation, operating supplies, and equipment and other disposable goods to the extent required for the performance of the applicable Research, Development or Manufacturing activities, (b) a pro rata allocation of equipment maintenance costs, utilities, general, administrative and facilities expenses, including allocated building operating costs and depreciation and repairs and maintenance and (c) other overhead, including costs and expense for information technology, human resources, finance and legal, in any case ((a), (b) or (c)), whether internal costs and expenses or amounts paid to Third Parties and allocated in accordance with such Party's customary allocation methodology consistently applied across its product portfolio.", "": "" }, { "Text": "1.101 \"IND\" means (a) an investigational new drug application filed with the FDA for authorization to commence clinical studies and its equivalent in other countries or regulatory jurisdictions and (b) all supplements and amendments that may be filed with respect to the foregoing.", "": "" }, { "Text": "1.102 \"Independent IP\" means any intellectual property or proprietary right of an Acquiring Entity conceived, discovered, generated, created, developed, or acquired after the Change of Control or Acquirer IP, provided that such Acquirer IP or other intellectual property or proprietary right: (a) is not conceived, discovered, generated, created, developed, acquired or otherwise made, or used, under or in connection with this Agreement; (b) (i) is not conceived, discovered, generated, created, developed, acquired or otherwise made using, and is not based on and does not incorporate, any Program Know-How, Capsida Background Know-How, Capsida Platform Know-How or Cargo Know-How or any part of the Capsida Platform, (ii) is not covered by or otherwise related to and does not incorporate or reference the Program Patents, Capsida Background Patents, Capsida Platform Patents or Cargo Patents (or any Know-How or inventions disclosed in any of the foregoing), and (iii) such conception, discovery, generation, creation, development, acquisition or making is kept separate from the activities performed under or in connection with this Agreement, and the Acquiring Entity has established reasonable internal safeguards designed to prevent any Program Know-How, Capsida Background Know-How, Capsida Platform Know-How, Cargo Know-How or the Confidential Information of the other Party from being disclosed to, or otherwise utilized by, the Acquiring Entity (other than Pre-Existing Affiliates); provided further that references to Capsida Background Know-How, Capsida Platform Know-How, Capsida Platform Patents and Capsida Background Patents in this definition shall not include any Capsida Background Know-How regarding, or Capsida Background Patents covering or claiming, the Manufacture of Capsids that is not specific to one (1) or more AbbVie Cargo, AbbVie Ophthalmology Cargo, Licensed Capsids, Licensed Ophthalmology Capsids, Licensed Product(s) or Licensed Ophthalmology Product(s); (c) is not Included IP; and (d) is not the Capsida Platform or Capsida Platform IP.", "": "" }, { "Text": "1.103 \"Inflation Reduction Act\" means 42 U.S.C. §§ 1320f et seq. and all its subsequent amendments and replacements.", "": "" }, { "Text": "1.104 \"Initial Capsid Option Period\" means, with respect to each of α-syn and Tau, the time period commencing on the Original Agreement Effective Date and ending the later of (a) sixty (60) days following the delivery by Capsida to AbbVie of the Final Data Package for Research Stage One for such Target and (b) fifty (50) days after AbbVie's receipt of such other information and Know-How (excluding any Highly Sensitive Know-How) in Capsida's Possession as AbbVie may reasonably request within fifteen (15) Business Days after its receipt of such Final Data Package that is reasonably necessary to inform its decision regarding whether to exercise the Initial Capsid Program Option.", "": "" }, { "Text": "1.105 \"Initial Capsid Program Option\" means the α-syn Program Option or Tau Program Option.", "": "" }, { "Text": "1.106 \"Initial Target Capsid Profile\" means, with respect to each Target, the initial target capsid profile for such Target set forth in the applicable Research Plan.", "": "" }, { "Text": "1.107 \"Initial Target Product Profile\" means, with respect to each Target, the initial target product profile for such Target set forth in the applicable Research Plan.", "": "" }, { "Text": "1.108 \"IVT\" means intravitreal administration.", "": "" }, { "Text": "1.109 \"Joint Governance Committee\" or \"JGC\" has the meaning set forth in Section 7.1.", "": "" }, { "Text": "1.110 \"Know-How\" means all inventions and technical, scientific and other know-how and information, trade secrets, knowledge, technology, means, methods, processes, practices, formulae, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings, assembly procedures, computer programs, apparatuses, specifications, data, results and other material, including: biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical, pre-clinical, clinical, safety, regulatory, manufacturing and quality control data and information, including study designs and protocols, assays and biological methodology, in each case (whether or not confidential, proprietary, patented or patentable) in written, electronic or any other form now known or hereafter developed.", "": "" }, { "Text": "1.111 \"Knowledge\" means, with respect to Capsida, the knowledge of the Chief Business Officer, VP of Technology, VP of Research and Chief Manufacturing Officer or internal legal counsel of Capsida or any of its Affiliates or any personnel holding positions equivalent to such job titles after performing a reasonably diligent investigation with respect to the applicable facts and information, which shall include a reasonable inquiry of, with respect to Patent-related matters, Capsida's outside patent counsel with respect to applicable facts and information.", "": "" }, { "Text": "1.112 \"Legal Dispute\" means any dispute, controversy or claim related to compliance with this Agreement or the validity, breach, termination or interpretation of this Agreement.", "": "" }, { "Text": "1.113 \"Licensed Capsid\" means any Licensed Capsid Program Capsid or any Licensed Collaboration Program Capsid.", "": "" }, { "Text": "1.114 \"Licensed Capsid Product\" means any Licensed Product containing a Licensed Capsid Program Capsid.", "": "" }, { "Text": "1.115 \"Licensed IP\" means the Capsida Background IP, the Capsida Platform IP, and Capsida's interest in any Program IP, Joint IP and Manufacturing IP.", "": "" }, { "Text": "1.116 \"Licensed Ophthalmology Capsid\" means each Selected Ophthalmology Capsid for a Route of Administration for which AbbVie has issued an Exercise Notice for such Route of Administration.", "": "" }, { "Text": "1.117 \"Licensed Ophthalmology Product\" means any product containing a Licensed Ophthalmology Capsid and one (1) or more AbbVie Ophthalmology Cargo directed to any Final Selected Ophthalmology Target. For clarity, a Licensed Ophthalmology Product that contains both the same Licensed Ophthalmology Capsid and AbbVie Ophthalmology Cargo, but in a different form, formulation, dosage form/strength or delivery mode (including Route of Administration), whether or not in combination with active moieties, shall be considered the same Licensed Ophthalmology Product. For further clarity, (a) a product containing the same AbbVie Ophthalmology Cargo as another Licensed Ophthalmology Product but which contains a different Licensed Ophthalmology Capsid shall be considered a different Licensed Ophthalmology Product, (b) a product containing the same Licensed Ophthalmology Capsid as another Licensed Ophthalmology Product but which contains a different AbbVie Ophthalmology Cargo directed to the same Final Selected Ophthalmology Target as such other Licensed Ophthalmology Product shall be considered the same Licensed Ophthalmology Product, and (c) a product containing the same Licensed Ophthalmology Capsid as another Licensed Ophthalmology Product but which contains a different AbbVie Ophthalmology Cargo directed to a different Final Selected Ophthalmology Target than such other Licensed Ophthalmology Product shall be considered a different Licensed Ophthalmology Product.", "": "" }, { "Text": "1.118 \"Licensed Product\" means any product containing a Licensed Capsid and one or more AbbVie Cargo directed to a Licensed Target. For clarity, a Licensed Product that contains both the same Licensed Capsid and AbbVie Cargo, but in a different form, formulation, dosage form/strength or delivery mode, whether or not in combination with active moieties, would be considered the same Licensed Product.", "": "" }, { "Text": "1.119 \"Major European Market\" means the United Kingdom, Germany, France, Italy and Spain.", "": "" }, { "Text": "1.120 \"Major Market\" means the United States and each Major European Market.", "": "" }, { "Text": "1.121 \"Manufacture\" and \"Manufacturing\" means all activities related to the making, having made, production, manufacture, processing, filling, finishing, packaging, labeling, shipping and holding of any product (including a Licensed Product or a Licensed Ophthalmology Product) or any intermediate of any of the foregoing, including formulation, process development, process qualification and validation, scale-up, pre-clinical, clinical and commercial manufacture and analytic development, product characterization, stability testing, quality assurance and quality control.", "": "" }, { "Text": "1.122 \"Manufacturing Cost\" means, to the extent specifically identifiable or reasonably allocable to any Licensed Product or Licensed Ophthalmology Product, the fully burdened manufacturing cost (including as applicable, Manufacturing, indirect labor (including allocations of costs for supervisory services, occupancy and similar functions and activities customarily treated as manufacturing plant overhead in accordance with GAAP) quality testing/review, project management, distribution, logistics, and any customs costs and expenses) without any markup or premium unless otherwise agreed, incurred by AbbVie or any of its Affiliates or incurred by Capsida or any of its Affiliates pursuant to Article 5, as determined in accordance with Accounting Standards, after the Effective Date and during the Term.", "": "" }, { "Text": "1.123 \"Manufacturing IP\" means Manufacturing Know-How and Manufacturing Patents.", "": "" }, { "Text": "1.124 \"Manufacturing Know-How\" means all Know-How specifically related to the Manufacture of Capsids that is conceived, discovered, generated, created, developed or otherwise made by or on behalf of a Party or any of its Affiliates, alone or jointly with the other Party or any of its Affiliates or any other Person, in performing its Manufacturing activities under or in connection with this Agreement. Manufacturing Know-How excludes Cargo Know-How and Capsida Platform Know-How.", "": "" }, { "Text": "1.125 \"Manufacturing Patents\" means any Patents that specifically claim Manufacturing Know-How. Manufacturing Patents exclude any Cargo Patents and any Capsida Platform Patents.", "": "" }, { "Text": "1.126 \"Marketing Authorization Application\" has the meaning set forth in the definition of \"Regulatory Approval Application\".", "": "" }, { "Text": "1.127 \"Medical Affairs Costs\" means those FTE Costs (charged in accordance with Section 9.15) incurred and the Out-of-Pocket Costs incurred by AbbVie or any of its Affiliates in accordance with Accounting Standards after the Effective Date and during the Term and pursuant to this Agreement that are specifically identifiable or reasonably allocable to medical affairs activities with respect to any ALS Product sold in the Territory.", "": "" }, { "Text": "1.128 \"Net Profits\" and, with correlative meaning, \"Net Losses\", means, with respect to the ALS Product for a given period during the Profit Share Term, Net Sales of such ALS Product in the Territory in such period less Allowable Expenses with respect to such ALS Product related to such period in the Territory.", "": "" }, { "Text": "1.129 \"Net Sales\" means, with respect to a Royalty Product for any period, the total amount billed or invoiced on sales of such Royalty Product during such period by AbbVie, its Affiliates, or Sublicensees in the Territory to Third Parties (including wholesalers and Distributors), in bona fide arm's length transactions, less the following deductions, and in each case related specifically to the Royalty Product and actually allowed and taken by such Third Parties and not otherwise recovered by or reimbursed to AbbVie, its Affiliates or Sublicensees:", "": "" }, { "Text": "(a) trade, cash and quantity discounts;", "": "" }, { "Text": "(b) price reductions or rebates, retroactive or otherwise, imposed by, negotiated with or otherwise paid to governmental authorities or other payees;", "": "" }, { "Text": "(c) taxes on sales (such as sales, value added, or use taxes) to the extent added to the sale price and set forth separately as such in the total amount invoiced;", "": "" }, { "Text": "(d) amounts repaid or credited by reason of rejections, defects, return goods allowance, recalls or returns, or because of retroactive price reductions, including rebates or wholesaler charge backs;", "": "" }, { "Text": "(e) the portion of administrative fees paid during the relevant time period to group purchasing organizations, pharmaceutical benefit managers or Medicare Prescription Drug Plans relating to such Royalty Product;", "": "" }, { "Text": "(f) any consideration actually paid or payable by AbbVie, its Affiliates or their respective Sublicensees for any Delivery System related to a billed or invoiced sale of such Royalty Product, where for purposes of this Net Sales definition, a \"Delivery System\" means any delivery system comprising equipment, instrumentation, one (1) or more devices, or other mechanical components (such as a syringe or infusion bag) designed to assist in the administration of such Royalty Product;", "": "" }, { "Text": "(g) any invoiced amounts from a prior period which are not collected and are written off by AbbVie, its Affiliates or Sublicensees, including bad debts;", "": "" }, { "Text": "(h) that portion of the annual fee on prescription drug manufacturers imposed by the Patient Protection and Affordable Care Act, Pub. L. No. 111-148 (as amended) to the extent reasonably allocable to sales of such Royalty Product;", "": "" }, { "Text": "(i) freight, insurance, import/export, and other transportation charges to the extent added to the sale price and set forth separately as such in the total amount invoiced, as well as any fees for services provided by wholesalers and warehousing chains related to the distribution of such Royalty Product; and", "": "" }, { "Text": "(j) any other similar and customary deductions that are consistent with Accounting Standards, but which are not duplicative of the above deductions.", "": "" }, { "Text": "Net Sales shall not include transfers or dispositions for charitable, promotional, pre-clinical, clinical or regulatory purposes. Net Sales shall include the amount or fair market value of all other consideration received by AbbVie, its Affiliates or Sublicensees in respect of such Royalty Product, whether such consideration is in cash, payment in kind, exchange or other form. Net Sales shall not include sales between or among AbbVie, its Affiliates, or Sublicensees.", "": "" }, { "Text": "Subject to the above, Net Sales shall be calculated in accordance with the standard internal policies and procedures of AbbVie, its Affiliates, or its or their Sublicensees, which must be in accordance with Accounting Standards.", "": "" }, { "Text": "For purposes of calculating Net Sales, all Net Sales shall be converted into Dollars in accordance with Section 9.17.", "": "" }, { "Text": "In the event a Royalty Product is a Combination Product, the Net Sales for such Combination Product shall be calculated as follows:", "": "" }, { "Text": "(i) If AbbVie, its Affiliate, or Sublicensee separately sells in such country or other jurisdiction, (A) a gene therapy product containing as its sole active ingredient, (x) with respect to a Licensed Product, the Licensed Capsid and AbbVie Cargo contained in such Combination Product, or (y) with respect to a Licensed Ophthalmology Product, the Licensed Ophthalmology Capsid and AbbVie Ophthalmology Cargo contained in such Combination Product (in each case, as applicable, the \"Mono Product\") and (B) gene therapy products containing as their sole active ingredients the other active moiety(ies) in such Combination Product, the Net Sales attributable to such Combination Product shall be calculated by multiplying actual Net Sales of such Combination Product by the fraction A/(A+B) where: \"A\" is AbbVie's (or its Affiliate's or Sublicensee's, as applicable) average Net Sales price during the period to which the Net Sales calculation applies for the Mono Product in such country or other jurisdiction and \"B\" is AbbVie's (or its Affiliate's or Sublicensee's, as applicable) average Net Sales price during the period to which the Net Sales calculation applies in such country or other jurisdiction, for gene therapy products that contain as their sole active ingredients the other active moiety(ies) in such Combination Product.", "": "" }, { "Text": "(ii) If AbbVie, its Affiliates, and Sublicensees do not separately sell in such country or other jurisdiction both the Mono Product and gene therapy products containing the other active moiety(ies) in such Combination Product, the Net Sales attributable to such Combination Product shall be determined by the Parties in good faith based on the relative fair market value of such Mono Product and such other active moiety(ies). If the Parties cannot agree on such relative value, the Dispute shall be resolved pursuant to Section 15.6.", "": "" }, { "Text": "1.130 \"Ophthalmology Program Capsid\" means any Capsid screened, generated, developed, engineered, optimized or used by or on behalf of Capsida under or in connection with the Ophthalmology Research Program.", "": "" }, { "Text": "1.131 \"Ophthalmology Program Option\" means each of the IVT Option, the SCS Option and the IC Option.", "": "" }, { "Text": "1.132 \"Ophthalmology Program Option Period\" means, in respect of the applicable Ophthalmology Program Option, the time period commencing on the Effective Date and ending on the later of (a) ninety (90) days following the delivery by Capsida to AbbVie of the Final Ophthalmology Data Package for the relevant Route of Administration and (b) fifty (50) days after AbbVie's receipt of such other information and Know-How (excluding any Highly Sensitive Know-How) in Capsida's Possession as AbbVie may reasonably request within fifteen (15) Business Days after its receipt of such Final Ophthalmology Data Package that is reasonably necessary to inform its decision regarding whether to exercise the applicable Ophthalmology Program Option.", "": "" }, { "Text": "1.133 \"Ophthalmology Research Program\" means all activities to be conducted by the Parties under the Ophthalmology Research Plan.", "": "" }, { "Text": "1.134 \"Ophthalmology Research Stage\" means each of the Build and Platform Development Research Stage, Initial Library Screening Research Stage, First Pooled Candidate Identification Studies Research Stage, Variant Optimization Research Stage, Secondary Pooled Ophthalmology CIS Research Stage, Final Variant Optimization Research Stage, Final Pooled Ophthalmology CIS Research Stage, and Single Variant Characterization Studies Research Stage.", "": "" }, { "Text": "1.135 \"Ophthalmology Rights\" has the meaning given to it in the preamble hereto.", "": "" }, { "Text": "1.136 \"Ophthalmology Selection Period\" means, with respect to each opportunity for AbbVie to make an election under Article 2A for a Route of Administration, the period commencing on the date that Capsida delivers to AbbVie the applicable Data Package for a such Route of Administration and ending on the earlier of: (a) the later of (i) the date that is twenty (20) days after the delivery by Capsida to AbbVie of such Data Package, and (ii) five (5) Business Days after the delivery by Capsida to AbbVie of such other information and Know-How (excluding any Highly Sensitive Know-How) in Capsida's Possession as AbbVie may reasonably request within five (5) Business Days after its receipt of such Data Package that is reasonably necessary for AbbVie to make such election for such Route of Administration; and (b) making of such election for such Route of Administration, as documented by the JGC.", "": "" }, { "Text": "1.137 \"Ophthalmology Target\" means a set of one (1) or more Target Components that are associated with one (1) or more AbbVie Indications. Each Ophthalmology Target shall constitute a single Ophthalmology Target regardless of the number of Target Components. Only the set of Target Components that constitute the Ophthalmology Target shall be an Ophthalmology Target, and the Target Components of a multi-specific Ophthalmology Target alone or in combination with other Target Components shall not constitute an Ophthalmology Target unless such Target Components alone or in combination with other Target Components is selected as an Ophthalmology Target.", "": "" }, { "Text": "1.138 \"Ophthalmology Target Capsid Profile\" means, with respect to each Route of Administration, the target Capsid profile for such Route of Administration as agreed by the Parties and as set forth in the Ophthalmology Research Plan.", "": "" }, { "Text": "1.139 \"Ophthalmology Transferred Materials\" has the meaning set forth in Section 2.12.1.", "": "" }, { "Text": "1.140 \"Opt-In\" means opting into the jurisdiction of Unified Patent Court, such as through withdrawal under Article 83(4) of the Agreement on a Unified Patent Court between the participating Member States of the European Union (2013/C 175/01) of the Opt-Out of a Patent.", "": "" }, { "Text": "1.141 \"Opt-Out\" means opting out of the jurisdiction of Unified Patent Court, such as the opt-out of a Patent from the exclusive competence of the Unified Patent Court under Article 83(3) of the Agreement on a Unified Patent Court between the participating Member States of the European Union (2013/C 175/01).", "": "" }, { "Text": "1.142 \"Optimization and Screening Activities\" means the activities conducted pursuant to Section 2.3 or Section 2.13, as applicable.", "": "" }, { "Text": "1.143 \"Option\" means a Capsid Program Option, the Collaboration Program Option, the IC Option, the IVT Option, or the SCS Option, as applicable.", "": "" }, { "Text": "1.144 \"Option Exercise Date\" means the date upon which AbbVie exercises any Option pursuant to Section 3.3.", "": "" }, { "Text": "1.145 \"Option Period\" means a Capsid Program Option Period, the Collaboration Program Option Period or an Ophthalmology Program Option Period, as applicable.", "": "" }, { "Text": "1.146 \"Original Neurology Rights\" has the meaning given to it in the preamble hereto.", "": "" }, { "Text": "1.147 \"Out-of-Pocket Costs\" means costs and expenses paid to Third Parties (or payable to Third Parties and accrued in accordance with the Accounting Standards consistently applied) by a Party (or its Affiliate) directly incurred in the conduct of any applicable activities under this Agreement, including costs for independent contractors engaged as permitted under this Agreement; provided that Out-of-Pocket Costs shall not include costs for general overhead, postage, communications, photocopying, printing or internet expense, professional dues, operating supplies, printers, photocopiers, fax machines or other office equipment, laboratory equipment, computers or computer service charges or any costs that are subsumed within the definition of Included FTE Costs and Expenses.", "": "" }, { "Text": "1.148 \"Patent Costs\" means those FTE Costs (charged in accordance with Section 9.15) and Out-of-Pocket Costs (including the reasonable fees and expenses paid to outside counsel and other Third Parties, and filing and maintenance fees paid to governmental authorities) incurred by a Party or any of its Affiliates in accordance with Accounting Standards under Article 10, (a) in connection with the Prosecution and Maintenance during the Profit Share Term of, or conducting Defense Proceedings with respect to, Product-Specific Patents, Program Patents or Joint Patents that cover the ALS Product in the Territory, and (b) except to the extent subject to indemnification under Section 13.1 or Section 13.2, litigation or other activities under Article 10 that relate to the Profit Share Term with respect to the ALS Product or any such Patents.", "": "" }, { "Text": "1.149 \"Patents\" means: (a) all national, regional and international patents and patent applications, including provisional patent applications and rights to claim priority from any of these patents or applications; (b) all patent applications filed either from such patents, patent applications or provisional applications or from an application claiming priority from either of these, including divisionals, continuations, continuations-in-part, provisionals, converted provisionals and continued prosecution applications; (c) any and all patents that have issued or in the future issue from the foregoing patent applications ((a) and (b)), including utility models, petty patents, innovation patents and design patents and certificates of invention; (d) any and all extensions or restorations by existing or future extension or restoration mechanisms, including revalidations, reissues, re-examinations and extensions (including any pediatric exclusivity, patent term extensions, supplementary protection certificates and the like) of the foregoing patents or patent applications ((a), (b) and (c)); and (e) any similar rights, including so-called pipeline protection or registration patent of any of such foregoing patent applications and patents.", "": "" }, { "Text": "1.150 \"Permitted Uses\" means (a) with respect to each item of a Party's Transferred Materials, the specific uses of such Transferred Material set forth in a Plan, (b) with respect to AbbVie as the receiving Party, the Exploitation of Licensed Capsids, Licensed Ophthalmology Capsids, Licensed Products, and Licensed Ophthalmology Products, in each case in accordance with the applicable licenses in Section 8.1 and (c) with respect to Capsida as the receiving Party, the Exploitation of the ALS Product in accordance with the POC Plan or the ALS Development Plan and Budget and in accordance with the applicable licenses in Section 8.2.", "": "" }, { "Text": "1.151 \"Person\" means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, unincorporated association, joint venture or other similar entity or organization, including a government or political subdivision, department or agency of a government.", "": "" }, { "Text": "1.152 \"Personal Data\" means any data that identifies or could identify a living person and does not include anonymized, key-coded data.", "": "" }, { "Text": "1.153 \"PHSA\" means the Public Health Service Act as set forth at 42 U.S.C. Chapter 6A, as may be amended from time to time, together with any rules, regulations and requirements promulgated thereunder (including all additions, supplements, extensions and modifications thereto).", "": "" }, { "Text": "1.154 \"Plan\" means each of the Capsid Program Research Plan, the RP2 Plan, the Collaboration Program Research Plan, the POC Plan, and the Ophthalmology Research Plan, as applicable.", "": "" }, { "Text": "1.155 \"POC Studies\" means, (a) with respect to Licensed Capsid Products or Licensed Ophthalmology Products, Clinical Trials conducted prior to the start of the first Registrational Trial for such product and (b) with respect to the ALS Product, Clinical Trials conducted under the POC Plan.", "": "" }, { "Text": "1.156 \"Pool Testing\" has the meaning set forth in the applicable Research Plan or the Ophthalmology Research Plan, as applicable.", "": "" }, { "Text": "1.157 \"Possession\" means with respect to a Party, Controlled by such Party or its Affiliates and in the possession of such Party, its Affiliate, or its or their contractors, consultants or agents. Possession shall not be deemed to require the disclosure or contribution of any Independent IP for the applicable selection, decision, transfer or other activity.", "": "" }, { "Text": "1.158 \"Processing\" has the meaning given to such term in the Data Protection Laws, and \"Process\" and \"Processed\" shall be construed accordingly.", "": "" }, { "Text": "1.159 \"Product-Specific IP\" means (a) all Patents included in the Licensed IP that specifically cover, and (b) all other Licensed IP specifically relating to, in each case ((a) and (b)), Licensed Capsid(s), Licensed Product(s), Licensed Ophthalmology Capsid(s), Licensed Ophthalmology Product(s) or the Exploitation thereof.", "": "" }, { "Text": "1.160 \"Profit Share Term\" means, with respect to the ALS Product, the period beginning on the Option Exercise Date with respect to the Collaboration Program Option and continuing for so long as the ALS Product is being Exploited in the Territory by or on behalf of AbbVie pursuant to this Agreement.", "": "" }, { "Text": "1.161 \"Program\" means (a) the rights and activities under this Agreement with respect to the Original Neurology Rights, including the Research Programs, POC Plan, and Program Capsids, Reserved Capsids, Selected Capsids, Licensed Capsids and Licensed Products (the \"Neurology Program\") or (b) the rights and activities under this Agreement with respect to the Ophthalmology Rights, including the Ophthalmology Research Program, Ophthalmology Program Capsids, Reserved Ophthalmology Capsids, Ophthalmology Research Products, Selected Ophthalmology Capsids, Licensed Ophthalmology Capsids and Licensed Ophthalmology Products (the \"Ophthalmology Program\"), as applicable.", "": "" }, { "Text": "1.162 \"Program Capsid\" means any Capsid screened, generated, developed, engineered or used by or on behalf of Capsida under or in connection with the Research Program.", "": "" }, { "Text": "1.163 \"Program IP\" means the Program Know-How and the Program Patents.", "": "" }, { "Text": "1.164 \"Program Know-How\" means all Know-How that is conceived, discovered, generated, created, developed or otherwise made by or on behalf of a Party or any of its Affiliates, either alone or jointly with the other Party or any of its Affiliates or any other Person, under (a) the Research Program or the POC Plan, including (i) any invention included in such Know-How (including inventions relating to promoters, enhancers or other post-transcriptional regulatory elements themselves (as opposed to their use)) and (ii) proteins, peptides or polynucleotides implicated in neurodegenerative diseases other than α-syn, Tau, or TDP-43 (or any target that is a component thereof), or (b) the Ophthalmology Research Program, including (i) any invention included in such Know-How (including inventions relating to promoters, enhancers or other post-transcriptional regulatory elements themselves (as opposed to their use)) and (ii) proteins, peptides or polynucleotides implicated in ophthalmological diseases (including the AbbVie Indications), including Ophthalmology Targets, but excluding in each case ((a) and (b)), any Manufacturing Know-How, Cargo Know-How, Capsida Platform Know-How and any Know-How that constitutes Transferred Materials, which shall be governed by Section 2.8 or Section 2.19, as applicable. For clarity, subject to the foregoing, Program Know-How shall include all Know-How that is conceived, discovered, developed or made under the (x) Research Program and relates to a product incorporating (1) a Capsid contributed by Capsida or any of its Affiliates and (2) an AbbVie Cargo, or Exploitation of any such product or (y) Ophthalmology Research Program and relates to a product incorporating (1) a Capsid contributed by Capsida or any of its Affiliates and (2) an AbbVie Ophthalmology Cargo, or Exploitation of any such product.", "": "" }, { "Text": "1.165 \"Program Patents\" means any Patents that specifically claim Program Know-How. Program Patents exclude any Manufacturing Patents, Cargo Patents and any Capsida Platform Patents. For clarity, Program Patents shall include all Patents claiming inventions that are conceived, discovered, generated, created, developed or otherwise made under the (a) Research Program and claim a product incorporating (1) a Capsid contributed by Capsida or any of its Affiliates and (2) an AbbVie Cargo, or Exploitation of such product or (b) Ophthalmology Research Program and claim a product incorporating (1) a Capsid contributed by Capsida or any of its Affiliates and (2) an AbbVie Ophthalmology Cargo, or Exploitation of such product.", "": "" }, { "Text": "1.166 \"Prosecution and Maintenance\" or \"Prosecute and Maintain\" means, with regard to a Patent, the preparation, filing, prosecution and maintenance of such Patent. For clarification, \"Prosecution and Maintenance\" or \"Prosecute and Maintain\" shall not include any Defense Proceedings or other enforcement actions taken with respect to a Patent.", "": "" }, { "Text": "1.167 \"Registrational Trial\" means, with respect to a Milestone Product, a Clinical Trial (whether or not designated a phase 3 clinical trial) for such Milestone Product with a sufficient number of subjects, (a) the results of which, together with prior data and information concerning such Milestone Product, are intended to establish that such Milestone Product is safe and effective for its intended indication; and (b) that forms the basis (alone or with one (1) or more additional Registrational Trials) of an effectiveness claim in support of Regulatory Approval of a BLA for such Milestone Product for its intended indication. For clarity, a Converted Trial shall only constitute a Registrational Trial for purposes of this Agreement from and after the Conversion Date with respect to such Converted Trial.", "": "" }, { "Text": "1.168 \"Regulatory Approval\" means, with respect to a country or other jurisdiction in the Territory, all approvals (including approvals of Regulatory Approval Applications), licenses, registrations, or authorizations of any Regulatory Authority necessary to commercially distribute, sell and market a product in such country or other jurisdiction, including, where applicable, (a) pricing or reimbursement approval in such country or other jurisdiction, (b) pre- and post-approval marketing authorizations (including any prerequisite Manufacturing approval or authorization related thereto), and (c) labeling approval.", "": "" }, { "Text": "1.169 \"Regulatory Approval Application\" means a BLA or any corresponding foreign application in the Territory, including, with respect to the European Union, a marketing authorization application filed with the EMA pursuant to the centralized approval procedure or with the applicable Regulatory Authority of a country in Europe with respect to the mutual recognition procedure or any other national approval (a \"Marketing Authorization Application\").", "": "" }, { "Text": "1.170 \"Regulatory Authority\" means any applicable supra-national, federal, national, regional, state, provincial or local regulatory agencies, departments, bureaus, commissions, councils, governmental authorities or other government entities regulating or otherwise exercising authority with respect to the Exploitation of Licensed Products or Licensed Ophthalmology Products in the Territory, including the FDA in the United States, the Medicines and Healthcare Products Regulatory Agency in the United Kingdom, and the EMA in the European Union.", "": "" }, { "Text": "1.171 \"Regulatory Documentation\" means: all (a) applications (including all INDs and Regulatory Approval Applications), registrations, licenses, authorizations and approvals (including Regulatory Approvals); (b) correspondence and reports submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority) and all supporting documents with respect thereto, including all adverse event files and complaint files; and (c) clinical and other data contained or relied upon in any of the foregoing; in each case ((a), (b) and (c)) relating to a Licensed Product or a Licensed Ophthalmology Product.", "": "" }, { "Text": "1.172 \"Regulatory Exclusivity Period\" means, with respect to each Licensed Product, ALS Reversion Product or Licensed Ophthalmology Product in any country in the Territory, a period of exclusivity (other than Patent-related exclusivity) granted or afforded by Applicable Law or by a Regulatory Authority in such country that confers an exclusive Commercialization period, including exclusive marketing rights, with respect to such Licensed Product, ALS Reversion Product or Licensed Ophthalmology Product in such country and prevents another party from using or otherwise relying on any data supporting the approval of the Regulatory Approval Application for such Licensed Product, ALS Reversion Product or Licensed Ophthalmology Product to support an application for regulatory approval of another product for any indication without the prior written consent of the Regulatory Approval Application holder.", "": "" }, { "Text": "1.173 \"Regulatory Expenses\" means those FTE Costs (charged in accordance with Section 9.15) and the Out-of-Pocket Costs (including filing, user, maintenance and other fees paid to Regulatory Authorities) incurred by or on behalf of AbbVie or any of its Affiliates in accordance with Accounting Standards that are specifically identifiable or reasonably allocable to the preparation of Regulatory Filings, and the obtaining and maintenance of all Regulatory Approval, during the Profit Share Term, for the Commercialization of the ALS Product, including compliance with all Regulatory Approvals and requirements of such Regulatory Authorities, adverse event recordation and reporting and regulatory affairs activities, the preparation and filing of any Regulatory Approval Application, including any filing or other fees in connection therewith, and in connection with advisory meetings in connection with the ALS Product, in each case in or for the United States.", "": "" }, { "Text": "1.174 \"Regulatory Filing\" means, with respect to a product, any documentation comprising any filing or application with any Regulatory Authority with respect to such product, or its use or potential use in the Field, including any such document submitted to or received from any Regulatory Authority, including any IND or Regulatory Approval Application, as well as any registration, license, authorization, and correspondence with any Regulatory Authority with respect to such product (including minutes of any meetings, telephone conferences or discussions with any Regulatory Authority to the extent relating specifically to such product and any adverse event files and complaint files to the extent relating specifically to such product).", "": "" }, { "Text": "1.175 \"Research\" means research, discovery and any non-clinical and pre-clinical activities relating to a Capsid, which, (a) with respect to the Research Program shall be up to but not including any IND-enabling studies and (b) with respect to the Ophthalmology Research Program shall be up to and including AbbVie's selection of the Selected Ophthalmology Capsids, including, as applicable, in each case ((a) and (b)), (i) discovery, identification, research, engineering, characterization, development, modification, optimization, testing and validation of Capsids, including for use with AbbVie Cargo, AbbVie Ophthalmology Cargo, Ophthalmology Research Products, and Research Products and (ii) cell specificity, localization and tolerability testing of the foregoing. \"Research\" may include Manufacturing solely to the extent necessary in support of the foregoing, but shall not include Development or Commercialization.", "": "" }, { "Text": "1.176 \"Research Program\" means the Capsid Research Program and the Collaboration Research Program.", "": "" }, { "Text": "1.177 \"Research Stage\" means Research Stage One and, if AbbVie exercises the Initial Capsid Program Option with respect to α-syn or Tau, Research Stage Two. For clarity, unless and until AbbVie exercises the Initial Capsid Program Option with respect to α-syn or Tau, Research Stage means Research Stage One.", "": "" }, { "Text": "1.178 \"Results\" means all data, analyses, conclusions and other information and other Know-How generated under or in connection with, or otherwise resulting from, the Research Program, the POC Plan or the Ophthalmology Research Plan, as applicable, excluding Highly Sensitive Know-How and raw sequence data other than Selected Capsids or Selected Ophthalmology Capsids.", "": "" }, { "Text": "1.179 \"Reversion IP\" means (a) (i) Know-How that (A) is owned or Controlled by AbbVie or any of its Affiliates as of the Effective Date and is conceived, discovered, generated, created, developed, acquired or otherwise made outside of the Research Program and (B) is not generally known, (ii) the Cargo Know-How, and (iii) and AbbVie's interest in the Program Know-How and Joint Know-How, in each case ((i)-(iii)) in existence as of the date of the ALS Reversion Triggering Event, and (b) (i) all Patents owned or Controlled by AbbVie or its Affiliates on or after the Effective Date, (ii) the Cargo Patents, and (iii) and AbbVie's interest in the Program Patents and Joint Patents, in each case ((a) and (b)) that specifically claims the ALS Reversion Product or Exploitation thereof, or that is necessary (or in the case of (b)(iii) only, reasonably useful) to Develop or Commercialize the ALS Reversion Product, in the Field in the Territory in the form that the ALS Reversion Product is being Developed or Commercialized as of the date of the ALS Reversion Triggering Event.", "": "" }, { "Text": "1.180 \"Route of Administration\" means IC, IVT or SCS, as applicable.", "": "" }, { "Text": "1.181 \"ROW Market\" means China and Japan.", "": "" }, { "Text": "1.182 \"Royalty Product\" means any Licensed Capsid Product or Licensed Ophthalmology Product, that, in each case, is sold by AbbVie, its Affiliates, or Sublicensees in the Territory to Third Parties (including wholesalers and Distributors).", "": "" }, { "Text": "1.183 \"Royalty Term\" means, with respect to each Royalty Product and each country in the Territory, the period beginning on the date of the First Commercial Sale of such Royalty Product in such country and ending on the latest to occur of: (a) the expiration, invalidation, irretrievable lapse, revocation, cancellation, dedication to the public, disclaimer or abandonment date of the last Valid Claim of a Capsida Background Patent or Program Patent in such country that claims such Royalty Product (excluding any Valid Claim that claims the formulation, dosage form or method of use or Manufacture of such Royalty Product); (b) the tenth (10th) anniversary of the First Commercial Sale of the first Royalty Product directed to the same Target (i.e., α-syn, Tau or TDP-43 in the case of a Licensed Capsid Product or a Final Selected Ophthalmology Target in the case of a Licensed Ophthalmology Product) in such country; and (c) the expiration of the Regulatory Exclusivity Period in such country for the first Royalty Product directed to the same Target (i.e., α-syn, Tau or TDP-43 in the case of a Licensed Capsid Product or a Final Selected Ophthalmology Target in the case of a Licensed Ophthalmology Product) in such country.", "": "" }, { "Text": "1.184 \"Sales and Marketing Costs\" means those FTE Costs (charged in accordance with Section 9.15) and the Out-of-Pocket Costs, incurred by AbbVie or any of its Affiliates in accordance with Accounting Standards, that are specifically identifiable or reasonably allocable to the sales and marketing of the ALS Product in the Territory during the Profit Share Term. Subject to the foregoing, Sales and Marketing Costs of AbbVie include costs incurred by or on behalf of AbbVie or its Affiliates in connection with the following activities:", "": "" }, { "Text": "(a) activities directed to the advertising and marketing of the ALS Product;", "": "" }, { "Text": "(b) launch meetings;", "": "" }, { "Text": "(c) advertising and public relations agencies, including development and distribution of selling and advertising and promotional materials relating to the use of the ALS Product, field literature, direct to consumer advertising campaigns, media/journal advertising, distribution of such advertising and promotional materials to the Parties' respective sales force personnel, exhibiting at seminars and conventions, convention costs, and promotional premiums;", "": "" }, { "Text": "(d) peer-to-peer activities such as lunch and dinner meetings;", "": "" }, { "Text": "(e) speakers programs, including training of such speakers;", "": "" }, { "Text": "(f) developing, obtaining, and providing training packages for the ALS Product, promotional literature, promotional materials, and other selling materials, including shipment costs of the same to AbbVie's central distribution facility and from AbbVie's central distribution facility to a Party's sales force personnel;", "": "" }, { "Text": "(g) transporting, housing and maintaining sales representatives for training and the costs of all training materials used for such purpose;", "": "" }, { "Text": "(h) developing and performing market research programs;", "": "" }, { "Text": "(i) developing and administering reimbursement programs;", "": "" }, { "Text": "(j) program costs for support of developing information and data specifically intended for national accounts, managed care organizations, Regulatory Authorities (e.g., federal, state and local), and other group purchasing organizations, including pull through activities;", "": "" }, { "Text": "(k) selling by Third Party independent contractors engaged by Parties as permitted by this Agreement;", "": "" }, { "Text": "(l) operation and maintenance of the sales representatives that promote the ALS Product (including payments made to Capsida pursuant to the Co-Promotion Agreement), sales bulletins and other communications, sales meetings, specialty sales forces, call reporting and other monitoring and tracking costs, district and regional sales management, home office personnel who support sales and marketing, development and copying of training, motivational and communications materials relating to the ALS Product, and other sales and marketing-related services ancillary to the foregoing (to the extent not otherwise falling within clause (g) above);", "": "" }, { "Text": "(m) call center set up, maintenance and operation for personnel used in connection therewith; and", "": "" }, { "Text": "(n) establishing and conducting one (1) or more training facilities for potential users of the ALS Product, including trainer costs, facility costs, supplies and user costs.", "": "" }, { "Text": "With respect to the ALS Product, Sales and Marketing Costs shall include costs of such activities that are incurred at any time during the Profit-Share Period with respect to the ALS Product (including prior to any Regulatory Approval of the ALS Product).", "": "" }, { "Text": "1.185 \"Screening Period\" means (a) with respect to Research Stage One, the period from the Original Agreement Effective Date until the earlier of: (i) the second (2nd) anniversary of the Original Agreement Effective Date and (ii) the date that the final individual Capsid-cargo characterization set forth in Section 2.3.8 as more fully defined in the applicable Research Plan has been initiated for the last Target, (b) with respect to Research Stage Two and for each Licensed Target (other than TDP-43), the period from the date, if any, that AbbVie exercises the applicable Initial Capsid Program Option for such Licensed Target until the earlier of the second (2nd) anniversary of the later of such date and the date that the JGC approves the RP2 Plan for such Licensed Target and the initiation of the Final Individual Capsid Cargo Characterization as defined in the RP2 Plan for such Licensed Target, and (c) with respect to the Ophthalmology Research Program the period from the Effective Date and ending on (i) delivery of a Final Ophthalmology Data Package for the last Route of Administration, or, if earlier, (ii) seventy-five (75) months after the Effective Date to the extent Capsida has used Commercially Reasonable Efforts to conduct the activities assigned to it under the Ophthalmology Research Plan to deliver a Final Ophthalmology Data Package for the last Route of Administration; provided that, in the case of this clause (ii), if at the end of such period, the Final Pooled Ophthalmology CIS Research Stage or the Single Variant Characterization Studies Research Stage is ongoing for one (1) or more Routes of Administration, then the Screening Period for such Route(s) of Administration shall continue until completion of the Final Pooled Ophthalmology CIS Research Stage and the Single Variant Characterization Studies Research Stage for such Route(s) of Administration, in each case ((a), (b) and (c)), as such period may be extended by the JGC pursuant to Section 2.2.3 or Section 2.12.2, as applicable.", "": "" }, { "Text": "1.186 \"SCS\" means suprachoroidal administration.", "": "" }, { "Text": "1.187 \"Selection Period\" means, with respect to each opportunity for AbbVie to make an election under Article 2 for a Target and a Research Stage, the period commencing on the date that Capsida delivers to AbbVie the applicable Data Package for such Target and Research Stage and ending on the earlier of: (a) the later of (i) the date that is ten (10) Business Days after the delivery by Capsida to AbbVie of such Data Package and (ii) five (5) Business Days after the delivery by Capsida to AbbVie of such other information and Know-How (excluding any Highly Sensitive Know-How) in Capsida's Possession as AbbVie may reasonably request within five (5) Business Days after its receipt of such Data Package that is reasonably necessary for AbbVie to make such election for such Target for such Research Stage; and (b) making of such election for such Target for such Research Stage, as documented by the JGC.", "": "" }, { "Text": "1.188 \"Senior Officer\" means, with respect to Capsida, its Chief Executive Officer and with respect to AbbVie, its Chief Scientific Officer.", "": "" }, { "Text": "1.189 \"Sublicensee\" means with respect to each Party, a Person, other than an Affiliate or a Distributor, that is granted a sublicense (or further right of reference), by such Party or its Affiliate under the grants in Section 8.1 or Section 8.2, as provided in Section 8.3, or, in the case of Capsida, a license under the Licensed IP, except for (a) any Third Party to which AbbVie grants a sublicense to settle or avoid litigation or any Patent dispute related to (i) the alleged infringement by a Licensed Product or by a Licensed Ophthalmology Product, as applicable, or the Exploitation thereof of any Patents or other intellectual property of a Third Party or (ii) the alleged non-infringement, invalidity or unenforceability of or challenge against any Patents covering or claiming a Licensed Product or a Licensed Ophthalmology Product, as applicable, and (b) any Third Party to which Capsida grants a (sub)license to settle or avoid litigation related to (i) the alleged infringement by the ALS Reversion Product or the Exploitation thereof of any Patents or other intellectual property of a Third Party or (ii) the alleged non-infringement, invalidity or unenforceability of any Patents covering or claiming the ALS Reversion Product (each such Third Party, a \"Settlement Sublicensee\" and any such sublicense agreement with such Settlement Sublicensee, a \"Settlement Sublicense Agreement\"). For clarity, Capsida and its Affiliates are not Sublicensees of AbbVie and AbbVie and its Affiliates are not Sublicensees of Capsida. Except with respect to any payments that are subject to Article 10, any payments received by a Party under a Settlement Sublicense Agreement with respect to sales of a Licensed Product or the ALS Reversion Product, as applicable, by the Settlement Sublicensee (but, for clarity, not the sales by such Settlement Sublicensee) shall be treated as Net Sales or Capsida Sales, as applicable for purposes of calculating royalty payments under Section 9.5 or Section 9.11, as applicable.", "": "" }, { "Text": "1.190 \"Target\" means each of α-syn, Tau and TDP-43.", "": "" }, { "Text": "1.191 \"Target Capsid Profile\" means, with respect to a Target, the Initial Target Capsid Profile for such Target and, if AbbVie exercises the Initial Capsid Program Option with respect to α-syn or Tau, the Additional Target Capsid Profile for such Target. References to Target Capsid Profile for a Target with respect to a Research Stage shall mean the Target Capsid Profile for such Target for such Research Stage. For clarity, unless and until AbbVie exercises the Initial Capsid Program Option with respect to α-syn or Tau, Target Capsid Profile for a Target means the Initial Target Capsid Profile for such Target. For clarity, the Initial Target Capsid Profiles are set forth in the Research Plans.", "": "" }, { "Text": "1.192 \"Target Component\" means (a) a human gene sequence identified by a GenBank accession number (or identified by similar information that uniquely identifies such gene sequence) or any variant thereof and (b) any protein expressed therefrom and any variant thereof in each case, that when bound to, activated, inhibited or otherwise modulated or delivered through gene therapy, has the potential to treat, prevent or ameliorate a disease, disorder or condition within the Field.", "": "" }, { "Text": "1.193 \"Target Product Profile\" means, with respect to a Target, the Initial Target Product Profile for such Target and, if AbbVie exercises the Initial Capsid Program Option with respect to α-syn or Tau, the Additional Target Product Profile for such Target. References to Target Product Profile for a Target with respect to a Research Stage shall mean the Target Product Profile for such Target for such Research Stage. For clarity, unless and until AbbVie exercises the Initial Capsid Program Option with respect to α-syn or Tau, Target Product Profile for a Target means the Initial Target Product Profile for such Target. For clarity, the Initial Target Product Profiles are set forth in the Research Plans.", "": "" }, { "Text": "1.194 \"Tau\" means the microtubule-associated protein tau gene designated MAPT (as exemplified by NCBI Reference Sequence Database record NG_007398) including all DNA haplotypes, gene duplications, polymorphisms, mutations or allelic variants of the MAPT locus, all mRNA products derived from the complete or partial MAPT gene (e.g., splice variants, missense mutations, truncations) and all forms of the tau protein (e.g., isoforms, fragments, mutations, conformations, posttranslational modifications, aggregate forms, intrinsically disordered proteins or other forms thereof) in human and other species.", "": "" }, { "Text": "1.195 \"TDP-43\" means the Transactive response DNA binding Protein 43 kDa (TDP-43) gene designated TARDBP (as exemplified by NCBI Reference Sequence Database record NG-008734) including all DNA haplotypes, gene duplications, polymorphisms, mutations or allelic variants of the TARDBP locus, all mRNA products derived from the complete or partial TDP-43 gene (e.g., splice variants, missense mutations, truncations) and all forms of the TDP-43 protein (e.g., isoforms, fragments, mutations, conformations, posttranslational modifications, aggregate forms, intrinsically disordered proteins or other forms thereof) in human and other species.", "": "" }, { "Text": "1.196 \"Terminated Territory\" means, with respect to a particular Program, each country with respect to which this Agreement is terminated in respect of such Program by either Party pursuant to Section 14.2.1 or AbbVie pursuant to Section 14.2.2, in either case, if such termination applies to one (1) or more countries, but not all of the countries in the Territory.", "": "" }, { "Text": "1.197 \"Territory\" means all of the countries in the world, including their respective territories and possessions, excluding, with respect to a particular Program, any Terminated Territory in respect of such Program.", "": "" }, { "Text": "1.198 \"Third Country\" or \"Third Countries\" means a country outside the EEA or a country not deemed to provide an adequate level of protection for Personal Data by the European Commission.", "": "" }, { "Text": "1.199 \"Third Party\" means any Person other than Capsida, AbbVie and their respective Affiliates.", "": "" }, { "Text": "1.200 \"Third Party Managed Patents\" means Existing NP Patents or Existing OP Patents, as applicable, for which neither Capsida nor any of its Affiliates has the first right to control Prosecution and Maintenance as of the Original Agreement Effective Date.", "": "" }, { "Text": "1.201 \"Third Party Right\" means any Patent, trade secret or other intellectual property right (but not any Trademark) of a Third Party in any country in the Territory.", "": "" }, { "Text": "1.202 \"Trademark\" means any mark, word, name, symbol, color, shape, designation or any combination thereof, including any trademark, service mark, trade name, brand name, sub-brand name, trade dress, product configuration, program name, delivery form name, certification mark, collective mark, logo, tagline, slogan, design or business symbol, that functions as an identifier of source or origin, whether or not registered and all statutory and common law rights therein and all registrations and applications therefor, together with all goodwill associated with, or symbolized by, any of the foregoing.", "": "" }, { "Text": "1.203 \"Trademark Costs\" means those FTE Costs (charged in accordance with Section 9.15) and Out-of-Pocket Costs (including the reasonable fees and expenses paid to outside counsel and other Third Parties, and filing and maintenance fees paid to governmental authorities) incurred by AbbVie or any of its Affiliates in accordance with Accounting Standards under Section 10.10, (a) in connection with the prosecution and maintenance of rights, including filing and registration fees with respect to the Trademark(s) applicable to the ALS Product for the Profit Share Term in the Territory, and (b) except to the extent subject to indemnification under Section 13.1 or Section 13.2, litigation, enforcement actions or other activities under Section 10.10 that relate to the Profit Share Term with respect to the ALS Product in the Territory or any such Trademark(s).", "": "" }, { "Text": "1.204 \"United States\" or \"U.S.\" means the United States of America and its territories and possessions (including the District of Columbia and Puerto Rico).", "": "" }, { "Text": "1.205 \"Valid Claim\" means a claim of (a) any issued and unexpired Patent whose validity, enforceability or patentability has not been affected by (i) irretrievable lapse, abandonment, revocation, cancellation, dedication to the public or disclaimer or (ii) a holding, finding or decision of invalidity, unenforceability or non-patentability by a court, governmental agency, national or regional patent office or other appropriate body that has competent jurisdiction, such holding, finding or decision being final and unappealable or unappealed within the time allowed for appeal, or (b) a pending patent application that is filed and prosecuted in good faith and no more than seven (7) years have elapsed from its earliest priority date. For clarity, a holding, finding or decision being final and unappealable or unappealed within the time allowed for appeal means a holding, finding or decision from which no appeal (other than a petition to the United States Supreme Court for a writ of certiorari or a similar appeal the consideration of which is subject to the discretion of the higher court) can be or has been taken.", "": "" }, { "Text": "1.206 \"wAMD\" means wet age-related macular degeneration of early, intermediate, or advanced classification.", "": "" }, { "Text": "INDEX OF ADDITIONAL DEFINED TERMS", "": "" }, { "Text": "Term Page Term Page", "": "" }, { "Text": "α-syn Program Option .................................. 70 AbbVie ........................................................... 1 AbbVie Background Know-How for ALS ............................................................ 2 AbbVie Background Know-How for Ophthalmology Research Program ............ 2 AbbVie Background Know-How for Research Program ...................................... 2 AbbVie Background Patents for ALS............ 3 AbbVie Background Patents for Ophthalmology Research Program ............ 3 AbbVie Background Patents for Research Program ...................................... 2 AbbVie Indemnitees .................................. 163 AbbVie Materials ......................................... 50 AbbVie Methods ........................................ 160 AbbVie Ophthalmology Materials ............... 66 AbbVie Reserved Field ................................ 65 Acquired Third Party ................................. 178 Acquirer ....................................................... 12 Acquirer IP ................................................. 177 Acquiring Entity......................................... 177 Additional Capsid Program Option ............. 70 Additional Target Capsid Profile ................. 49 Additional Target Product Profile ................ 49 ADR ........................................................... 179 Agreement ...................................................... 1 ALS .............................................................. 42 ALS Cargo ................................................... 50 ALS Commercialization Plan ...................... 91 ALS Development Plan and Budget ............ 79 ALS Milestone Event ................................. 120 ALS Milestone Payments .......................... 120 ALS Reversion Royalty Term ................... 121 Amount ...................................................... 125 Auditor ....................................................... 127 Back-Up Capsids ......................................... 48 Biosimilar Application ............................... 134 Breaching Party .......................................... 168 Build and Platform Development Research Stage ......................................... 56 CalTech IP ................................................. 104", "": "" }, { "Text": "Capsid Exclusive License ............................ 70 Capsid Patent ............................................. 130 Capsid Program Research Plan ................... 43 Capsida .......................................................... 1 Capsida Indemnitees .................................. 163 Capsida NP Regulatory Filings ................. 149 Capsida OP Regulatory Filings ................. 153 Change of Control Party ............................ 177 Co-Development Costs ................................ 80 Collaboration Program Option .................... 70 Collaboration Program Research Plan ......... 43 Commercial Scale-Up Transition Event ...... 87 Confidential Information ........................... 141 Conversion Date .......................................... 14 Co-Promotion Agreement ........................... 92 Co-Promotion Option .................................. 91 Co-Promotion Option Exercise Notice ........ 91 Co-Promotion Product ................................. 91 Co-Promotion Readiness Plan ..................... 91 Data Breach ............................................... 162 Defense Proceeding ................................... 130 Deferred Co-Development Costs ................ 80 Disclosing Party ......................................... 141 Dispute ....................................................... 179 DOJ .............................................................. 20 Effective Date ................................................ 1 Excluded Program ..................................... 178 Existing CMO Agreements ......................... 85 Existing Confidentiality Agreements ........ 142 Existing NP Patents ................................... 147 Existing OP Patents ................................... 152 Final Pooled Ophthalmology CIS ............... 61 Final Pooled Ophthalmology CIS Research Stage ........................................ 61 Final Selected Ophthalmology Target ......... 66 Final Variant Optimization Research Stage ........................................................ 60 First Party .................................................. 131 First Pooled Candidate Identification Studies Research Stage ............................ 59 FTC .............................................................. 20 General Capsid Library ............................... 44", "": "" }, { "Text": "General Ophthalmology Capsid Library ...... 57 HSR Proceeding ........................................... 74 IC Option ..................................................... 70 Inbound Licensor ....................................... 103 Included IP ................................................. 177 Indemnification Claim Notice .................... 165 Indemnified Party....................................... 165 Indemnitee.................................................. 165 Indirect Taxes............................................. 126 Infringement ............................................... 133 Infringement Action ................................... 133 Initial Library Screening Research Stage .... 57 Invoiced Party ............................................ 124 Invoicing Party ........................................... 124 IVT Option ................................................... 70 JGC .............................................................. 93 Joint Governance Committee ....................... 93 Joint IP ....................................................... 128 Joint Know-How ........................................ 128 Joint Patents ............................................... 128 Licensed Capsid Program Capsids............... 71 Licensed Collaboration Program Capsids .... 71 Licensed Ophthalmology Capsids ............... 71 Licensed Target ............................................ 71 Manufacturing Process................................. 87 Manufacturing Process Know-How ............. 87 Manufacturing Technology Transfer ........... 87 Marketing Authorization Application .......... 31 Milestone Events ........................................ 111 Milestone Payments ................................... 111 Milestone Product ...................................... 111 Modification Date ...................................... 170 Mono Product............................................... 26 Neurology Initial Disclosure Schedule ...... 147 Neurology Option Bringdown Date ........... 147 Neurology Program ...................................... 30 Neutral.................................... Schedule 15.6.3 Non-Breaching Party ................................. 168 Non-Commercial Supply Transition Event ........................................................ 86 Notice Period ............................................. 168 Ophthalmology Initial Disclosure Schedule ................................................. 151 Ophthalmology Milestone Events.............. 114 Ophthalmology Milestone Payments ......... 114 Ophthalmology Milestone Product ............ 114", "": "" }, { "Text": "Ophthalmology Option Bringdown Date .. 151 Ophthalmology Program ............................. 30 Ophthalmology Research Plan .................... 55 Ophthalmology Research Product ............... 54 Ophthalmology Research Product Candidates ............................................... 63 Ophthalmology Research Program Records .................................................... 67 Ophthalmology Terms ............................... 183 Ophthalmology Transferred Materials ........ 55 Original Agreement ....................................... 1 Original Agreement Effective Date ............... 1 Parties ............................................................ 1 Party ............................................................... 1 POC Plan ..................................................... 79 Pooled Screening ......................................... 46 Pre-Existing Affiliate ................................. 178 Primary Capsid ............................................ 48 Product Trademarks ................................... 139 Product-Specific Patents .............................. 73 Program Activities ..................................... 104 Prosecuting Party ....................................... 131 Qualified CMO Agreement ......................... 86 Receiving Party ......................................... 141 Research Plans ............................................. 43 Research Product ......................................... 42 Research Product Candidates ...................... 48 Research Program Records .......................... 51 Research Stage One ..................................... 42 Research Stage Two .................................... 42 Reserved Capsids ......................................... 45 Reserved Ophthalmology Capsids .............. 57 RP2 Plan ...................................................... 43 SCS Option .................................................. 70 Secondary Pooled Ophthalmology CIS ....... 60 Secondary Pooled Ophthalmology CIS Research Stage ........................................ 60 Selected Capsids .......................................... 48 Selected Ophthalmology Capsids ................ 62 Selected Ophthalmology Target .................. 65 Settlement Sublicense Agreement ............... 36 Settlement Sublicensee ................................ 36 Shared Capsid .............................................. 84 Single Variant Characterization Studies ...... 62 Subject Technology ................................... 104 Subject Technology Agreement ................ 104", "": "" }, { "Text": "Supplied Research Materials........................ 85 Supply Transition Event .............................. 87 Target List .................................................... 64 Target-specific Capsid Libraries .................. 47 Tau Program Option .................................... 70 Technology Transfer Plan ............................ 87 Term ........................................................... 167 Termination Notice .................................... 168", "": "" }, { "Text": "Third Party Claims .................................... 163 Third Party Infringement Claim ................ 137 Third Party Payments ................................ 119 Transferred Materials .................................. 43 Updated Disclosure Schedule .................... 157 Variant Optimization Research Stage ......... 59 Withholding Party ..................................... 125 Working Group ............................................ 98", "": "" }, { "Text": "ARTICLE 2 RESEARCH PROGRAM", "": "" }, { "Text": "2.1 General. The principal objectives of the Research Program are for Capsida to: (a) (i) use the Capsida Platform and Capsida Platform IP to engineer, optimize, evaluate and deliver to AbbVie at least three (3) Capsids for each of α-syn and Tau (one (1) lead Capsid and two (2) back-up Capsids) that meet the Initial Target Capsid Profile for such Target, (ii) further optimize and characterize one (1) Capsid selected by AbbVie for each Target with AbbVie Cargo and any Expression Elements provided by AbbVie or selected by the JGC for each Target and, together with AbbVie, validate assembled construct(s) that contain such optimized Capsid(s), AbbVie Cargo and Expression Elements for each such Target (each, a \"Research Product\"), and (iii) Manufacture and supply Capsids and Research Products for use in connection with the Research Program and develop processes (which, for clarity, prior to exercise of the applicable Option, does not include Target-specific process development) for the Manufacture of Capsids and Research Products for use in the Research Program and in preparation for the generation of materials for GLP toxicology studies and clinical supply; (b) (i) use the Capsida Platform and Capsida Platform IP to engineer, optimize, evaluate and deliver to AbbVie at least three (3) Capsids for TDP-43 (one (1) lead Capsid and two (2) back-up Capsids) that meet the Initial Target Capsid Profile for such Target for the amyotrophic lateral sclerosis (\"ALS\") indication, (ii) further optimize and characterize one (1) Capsid selected by AbbVie for such Target with AbbVie Cargo and any Expression Elements provided by AbbVie or selected by the JGC for TDP-43 and, together with AbbVie, validate Research Product(s) that contain such optimized Capsid(s), AbbVie Cargo and Expression Elements for ALS, and (iii) Manufacture and supply Capsids and Research Products for use in connection with the Research Program and develop processes (which, for clarity, prior to exercise of the applicable Option, does not include Target-specific process development) for the Manufacture of Capsids and Research Products for use in the Research Program and in preparation for the generation of materials for GLP toxicology studies and clinical supply; provided, further, that prior to AbbVie's exercise of the applicable Initial Capsid Program Option or Collaboration Program Option, the Parties may also mutually agree to an amendment to have Capsida support process development and supply Capsids for GLP toxicology studies (the activities described in clauses (a) and (b) collectively, \"Research Stage One\"); and (c) if AbbVie exercises the Initial Capsid Program Option with respect to α-syn or Tau, (i) use the Capsida Platform and the Capsida Platform IP to engineer, optimize, evaluate and deliver to AbbVie at least three (3) additional Capsids for each such Target (one (1) lead Capsid and two (2) back-up Capsids) that meet the Additional Target Capsid Profile for each such Target, (ii) further optimize and characterize one (1) Capsid selected by AbbVie for each Target with AbbVie Cargo and any Expression Elements provided by AbbVie or selected by the JGC for such Target and, together with AbbVie, validate assembled Research Product(s) that contain such optimized Capsid(s), AbbVie Cargo and Expression Elements for each such Target, and (iii) Manufacture and supply Capsids and Research Products for use in connection with the Research Program and develop processes (which, for clarity, prior to exercise of the applicable Option, does not include Target-specific process development) for the Manufacture of Capsids and Research Products for use in the Research Program and in preparation for the generation of materials for GLP toxicology studies and clinical supply (\"Research Stage Two\"). The Research Program will be conducted by each Party in good scientific manner, and in compliance with all Applicable Law.", "": "" }, { "Text": "2.2 Research Plans.", "": "" }, { "Text": "2.2.1 General. The Parties shall conduct (a) Research Stage One in accordance with a written research plan (i) for each of α-syn and Tau (the \"Capsid Program Research Plan\") and (ii) for TDP-43 (the \"Collaboration Program Research Plan\") and (b) if AbbVie exercises the Initial Capsid Program Option with respect to α-syn or Tau, Research Stage Two in accordance with a written research plan for each Target with respect to which the Initial Capsid Program Option is exercised for the optimization of Capsids informed by the Results of Research Stage One for such Target and the latest Capsida Platform IP (each, an \"RP2 Plan\" and together with the Capsid Program Research Plan and the Collaboration Program Research Plan, the \"Research Plans\"). The initial Capsid Program Research Plan is attached hereto as Exhibit A. The initial Collaboration Program Research Plan is attached hereto as Exhibit B. Each Research Plan shall detail (A) the responsibilities and activities of Capsida and AbbVie, (B) projected timelines for completion of such responsibilities and activities and an estimated budget therefor, (C) the Target Capsid Profile and the Target Product Profile for each Target, (D) the Results required to be included in each Data Package, including any requirements with respect to the format, delivered to the JGC to demonstrate that the Target Capsid Profile and the Target Product Profile for each Target have been achieved, (E) any biological materials or research tools to be provided by a Party for use by the other Party in the Research Program (such materials and tools, together with, to the extent not constituting Cargo IP, Capsida Platform IP or Program IP, any analogues, progeny, expression products, mutants, replicates, derivatives, modifications, enhancements and improvements thereof generated by or on behalf of such Party or any of its Affiliates, collectively the \"Transferred Materials\") and the Permitted Uses of the Transferred Materials by the receiving Party (for clarity, the Capsids and Expression Elements shall not be Transferred Materials) and (F) certain Capsids and other materials to be provided by Capsida to AbbVie. In addition, the Collaboration Program Research Plan shall include specific Research activities to be performed by Capsida focused on developing in vitro and in vivo model systems for preclinical evaluation of Capsids for ALS and evaluating potential AbbVie Cargo directed to TDP-43 in such models.", "": "" }, { "Text": "2.2.2 RP2 Plan. Within thirty (30) days after the Option Exercise Date for an Initial Capsid Program Option, the Parties, through the JGC, shall (a) prepare the RP2 Plan for the applicable Target, which shall be substantially similar to the then-current Capsid Program Research Plan for such Target with any such modifications as are necessary to address learnings from Research Stage One or the latest Capsida Platform IP or to achieve the Additional Target Capsid Profile or Additional Target Product Profile for such Target and (b) develop the Additional Target Capsid Profiles and Additional Target Product Profile for such Target based on the Results from the Research Program and the latest Capsida Platform IP.", "": "" }, { "Text": "2.2.3 Amendments to Research Plans. The JGC shall review each Research Plan quarterly for the purpose of considering appropriate amendments thereto, and either Party, through its representatives on the JGC, may propose amendments to any Plan at any time. Each Party may propose an amendment to a Research Plan by submitting such proposed amendment in writing to the JGC for review and approval, subject to the final decision-making process set forth in Section 7.2.3; provided, however, that (a) any amendment to a Research Plan that would not (i) result in an increase to the corresponding budget estimate by more than ten percent (10%), (ii) increase the associated Screening Period by more than three (3) months or (iii) make the use of Independent IP necessary, shall be subject to the review and approval by the applicable Working Group, and (b) any other amendment shall be considered promptly by each Party, and to be effective must be mutually agreed to by the Parties either in writing, or through the JGC as reflected in JGC meeting minutes signed by the Alliance Managers in accordance with Section 7.2.1, such agreement not to be unreasonably withheld, conditioned or delayed. The calculation of the whether the costs of an amendment would exceed the corresponding budget shall be based on the FTE Costs (charged in accordance with Section 9.15) and the Out-of-Pocket Costs incurred by or on behalf of Capsida or any of its Affiliates. For clarity, operational, day-to-day decisions with respect to the implementation of the Research Plan(s), including modifications described in Section 2.2.3, do not need to be submitted as an amendment, but changes with respect to (i) the imposition of any obligation of AbbVie to deliver any materials or perform any activities, (ii) any uses of any AbbVie Materials for purposes of performance of the Research Plans, or (iii) requirements for (including the scope of results and data to be provided in) a Data Package or Final Data Package, would require an amendment to the applicable Research Plan. For further clarity, budget overruns do not need to be submitted as an amendment to the applicable Research Plan and do not constitute or require amendments to the Research Plan(s). Upon the Alliance Managers' signing the minutes of the JGC pursuant to Section 7.2.1 memorializing the agreement of the JGC to, or mutual written agreement by the Parties of, as applicable, an amendment to a Research Plan, such Research Plan shall be deemed to be amended by such amendment.", "": "" }, { "Text": "2.2.4 Modifications to the Research Program. The Parties acknowledge and agree that the Research Plans are not prescriptive, but instead set forth the activities that the Parties reasonably expect as of the Effective Date will need to be performed to achieve the objectives of the Research Program. Based on the further development of the Capsida Platform, including Capsida Platform IP, general learning in the field and the Results of the Research Program, the specific activities under the Research Program may need to be modified to achieve the objectives of the Research Program. Changes in the sequencing of activities, repeating activities or performing activities of a similar nature, in each case to those set forth in the Research Plans shall be discussed and approved by the JGC, such approval not to be unreasonably withheld, conditioned or delayed. The JGC shall periodically evaluate the activities under the Research Program to determine whether the objectives of the Research Program for each Target for each Research Stage are likely to be achieved and to determine what if any changes should be made to the Research Plans to best do so.", "": "" }, { "Text": "2.3 Capsid Generation, Optimization and Screening.", "": "" }, { "Text": "2.3.1 Initial Library Screening. Pursuant to each Research Plan, Capsida shall generate at least one (1) de novo library of Capsids per Target (e.g., with 7-mer insertions at the AA588 loop of AAV9) using the Capsida Platform, comprising approximately thirty-four billion nucleic acid sequences for differentiated engineered Capsids (unless otherwise agreed in the Research Plan) (each, a \"General Capsid Library\"). The General Capsid Library for each Target will be screened through two (2) rounds of screening in non-human primates. The first round of screening will involve a random selection of Capsids from the General Capsid Library. The second round of screening will be conducted using Capsids from the first round of screening selected by the JGC that are most likely to achieve the Target Capsid Profile for the applicable Target. The General Capsid Library for Tau was generated and screened prior to the Effective Date, but shall otherwise be subject to this Section 2.3.1 in all respects. On a Target-by-Target basis, after both rounds of initial library screening are completed, Capsida shall deliver to AbbVie the associated Data Package(s) as more fully described in the Research Plan and such other information and Know-How (excluding any Highly Sensitive Know-How) in Capsida's Possession as AbbVie may reasonably request that is reasonably necessary to inform its selection. After the applicable Data Package(s) are delivered by Capsida to AbbVie, AbbVie shall have the right during each corresponding Selection Period, to select up to five (5) Capsids per Target as \"Reserved Capsids\" and such Capsids shall be used in the Capsid optimization process, as described below and in the applicable Research Plan. Capsida may generate additional de novo Capsid libraries and if it screens any such library for activity in and directed to the central nervous system during the Screening Period, such library shall be deemed to be a General Capsid Library and Capsida shall deliver to AbbVie a Data Package (and such other information and Know-How (excluding any Highly Sensitive Know-How) in Capsida's Possession as AbbVie may request that is reasonably necessary to make its decision with respect to such Data Package) detailing such screening, such General Capsid Library shall be subject to this Section 2.3.1 and upon delivery of the Data Packages, AbbVie shall have the right to designate one or more Capsids from such General Capsid Library as Reserved Capsids during the corresponding Selection Period, provided that it deselects a corresponding number of Reserved Capsids.", "": "" }, { "Text": "Each General Capsid Library (including the General Capsid Library for Tau generated prior to the Effective Date) shall be and remain exclusive to AbbVie, and Capsida shall not use or Exploit (except to conduct the Research Program), or grant any Third Party the right to use or Exploit, any Capsid in such General Capsid Library, until the earlier of the end of the Selection Period for such General Capsid Library (provided that the Selection Period for the General Capsid Library for Tau shall be thirty (30) days and AbbVie shall have fifteen (15) days from the date that the Data Package(s) for such General Capsid Library are delivered to it, to request additional information and Know-How (excluding any Highly Sensitive Know-How) from Capsida) and the date that AbbVie selects five (5) Capsids from such General Capsid Library as Reserved Capsids for each Target, subject to Section 8.8.", "": "" }, { "Text": "For each new Reserved Capsid with respect to a Target that AbbVie selects in excess of five (5) Reserved Capsids for such Target under this Section 2.3.1, AbbVie shall have to deselect an existing Reserved Capsid, such that AbbVie does not have more than five (5) Reserved Capsids for such Target under this Section 2.3.1. For clarity, Capsida shall be free to use any such deselected Capsid that is not a Reserved Capsid or a Selected Capsid or subject to exclusivity under this Article 2, outside of this Agreement, subject to Section 8.8.", "": "" }, { "Text": "2.3.2 Variant Optimization. In accordance with the applicable Research Plans, Reserved Capsids from the initial library screening described in Section 2.3.1 (or with respect to each Research Stage Two, the Selected Capsids for the applicable Licensed Target and such other Reserved Capsids as AbbVie may select (not to exceed five (5) per Licensed Target)) will proceed to re-diversification and stabilizing library screening. Capsida will optimize the five (5) Reserved Capsids or fewer if so determined by the JGC (or the Selected Capsids and other Reserved Capsids selected by AbbVie) to generate at least one (1) diversification and stabilizing library per Target for each Research Stage using a scanning 3-mer diversification strategy, unless otherwise agreed by the JGC, and the latest Capsida Platform IP. Capsida will screen each diversification and stabilizing library through at least two (2) rounds of screening in non-human primates. The first round of screening for each re-diversification and screening library shall use the entire library and the second round shall use Capsids selected by the JGC, in each case together with naturally occurring AAV9 and such other benchmark Capsids as the JGC shall determine. Capsida shall deliver to AbbVie a Data Package after each round of screening and such other information and Know-How (excluding Highly Sensitive Know-How) in Capsida's Possession as AbbVie may reasonably request that is reasonably necessary to make its decision with respect to such Data Package. After all rounds of screening are completed and the associated Data Packages are delivered to AbbVie for each diversification and screening library, on a Target-by-Target basis, AbbVie shall have the right during each corresponding Selection Period, to select up to five (5) Capsids per Target as Reserved Capsids, which will progress to the pooled screening process, as described below.", "": "" }, { "Text": "2.3.3 Pooled Screening. For each Target and for each Research Stage, the Reserved Capsids for such Target and such Research Stage and one or more additional Reserved Capsids for other Targets or Research Stages, together with top performing variants and benchmark Capsids (including AAV9) identified and agreed upon by the JGC, shall be pooled and further screened in non-human primates (the \"Pooled Screening\"). Capsida shall deliver to AbbVie a Data Package after each round of Pooled Screening (and such other information and Know-How (excluding any Highly Sensitive Know-How) in Capsida's Possession as AbbVie may reasonably request that is reasonably necessary to inform its selection). AbbVie shall have the right on a Target-by-Target and Research Stage-by-Research Stage basis during each corresponding Selection Period, after Capsida completes the Pooled Screening in accordance with the applicable Research Plan and delivers to AbbVie the resulting Data Package(s) as more fully described in the Research Plan, to select up to five (5) Capsids for each Target as Reserved Capsids for further advancement in accordance to the Research Plan. Such process shall be subject to deselection of any existing Reserved Capsids so that AbbVie does not have more than five (5) Reserved Capsids with respect to a Target for a Research Stage for Pooled Screening at any time.", "": "" }, { "Text": "2.3.4 Preliminary Characterization. Based upon the Data Packages associated with Capsid optimization and pooled screening, each as described above and in the applicable Research Plan, AbbVie shall have the right to determine whether to proceed with preliminary capsid characterization of up to three (3) Reserved Capsids for each Target for each Research Stage. Capsida shall generate Research Product Candidates (as defined below) for each Reserved Capsid selected by AbbVie using cargo, which may be AbbVie Cargo or tool cargo, and Expression Elements, which may include AbbVie Transferred Materials, in each case as selected by the JGC and shall perform for each such Reserved Capsid selected by AbbVie studies approved by the JGC that are designed to determine tissue biodistribution, cell type specificity, transduction, duration of expression, immunogenicity and safety/toxicology profile to make the determination as to whether the Reserved Capsids meet the Target Capsid Profile. Capsida shall deliver to AbbVie with a Data Package after completion of such studies and such other information and Know-How (excluding Highly Sensitive Know-How) in Capsida's Possession as AbbVie may reasonably request that is reasonably necessary to make its decision with respect to such Data Package. Upon completion of both (a) the preliminary characterization activities for each such Reserved Capsid (i.e., each of the up to three (3) Reserved Capsids selected by AbbVie pursuant to the first sentence of this Section 2.3.4) for a Target for a Research Stage and (b) the final Pooled Screening for the five (5) Reserved Capsids selected by AbbVie pursuant to Section 2.3.6 for such Target for such Research Stage and delivery of the Data Packages to AbbVie for each of the foregoing, AbbVie shall have the right to select any of such Reserved Capsids (or any other Reserved Capsids) as Selected Capsids pursuant to Section 2.3.6.", "": "" }, { "Text": "2.3.5 Final Capsid Optimization. In parallel with Preliminary Characterization for each Target for each Research Stage, unless otherwise determined by the JGC, Capsida shall perform further Capsid optimization using the five (5) Reserved Capsids or fewer if so determined by the JGC selected by AbbVie pursuant to Section 2.3.3 for such Target for such Research Stage (or any such other Reserved Capsid as AbbVie may elect to substitute therefor). Capsida will generate one or more Target-specific Capsid libraries (\"Target-specific Capsid Libraries\") per Target per Research Stage using AbbVie-selected Reserved Capsids and a scanning 3-mer diversification strategy, and the latest Capsida Platform IP, unless otherwise agreed by the JGC. Capsida will screen each Target-specific Capsid Library through up to two rounds of screening in non-human primates. The first round of screening for each re-diversification and screening library shall use the entire library and the second round shall use Capsids selected by the JGC, in each case together with naturally occurring AAV9 and such other benchmark Capsids as the JGC shall determine. Capsida shall deliver to AbbVie a Data Package after each round of screening (as more fully described in the applicable Research Plan data deliverables table) and such other information and Know-How (excluding any Highly Sensitive Know-How) in Capsida's Possession as AbbVie may reasonably request that is reasonably necessary to make its decision with respect to such Data Package. After all rounds of screening are completed and the associated Data Packages for each diversification and screening library, on a Target-by-Target and Research Stage-by-Research Stage basis, are delivered to AbbVie, AbbVie shall have the right during each corresponding Selection Period (and without limiting AbbVie's rights with respect to the Reserved Capsids selected by AbbVie pursuant to Section 2.3.4 for preliminary characterization), to select up to five (5) Capsids per Target for each Research Stage as Reserved Capsids, which will progress to the Pooled Screening in Section 2.3.6, as more fully described in the applicable Research Plan.", "": "" }, { "Text": "2.3.6 Final Pooled Screening. Following the final capsid optimization, as described in Section 2.3.5, for each Target and for each Research Stage, the Reserved Capsids for such Target and for Research Stage and one or more additional Reserved Capsids for other Targets or Research Stages together with top performing variants and benchmark Capsids (including AAV9) identified and agreed upon by the JGC, shall undergo Pooled Screening, as more fully described in the applicable Research Plan. Capsida shall deliver to AbbVie a Data Package after such final Pooled Screening and such other information and Know-How (excluding Highly Sensitive Know-How) in Capsida's Possession as AbbVie may reasonably request that is reasonably necessary to make its decision with respect to such Data Package. On a Target-by-Target and Research Stage-by-Research Stage basis, AbbVie shall have the right, until twenty (20) days after Capsida both (a) completes the final Pooled Screening pursuant to Section 2.3.6 and the preliminary characterization pursuant to Section 2.3.4 for such Target for such Research Stage in accordance with the applicable Research Plan and (b) delivers to AbbVie (i) the Data Packages for each of the foregoing (and such other information and Know-How in Capsida's Possession as AbbVie may reasonably request within ten (10) days after the delivery of the last such Data Package that is reasonably necessary to inform its selection of the Reserved Capsids) to select up to five (5) Capsids for each Target as Reserved Capsids to select among for final individual Capsid-cargo characterization of a single Capsid, subject to deselection of any existing Reserved Capsids so that AbbVie does not have more than five (5) Reserved Capsids with respect to a Target after such selection.", "": "" }, { "Text": "2.3.7 Vector Design and Optimization. From and after the initial Capsid library screening for a Target for a Research Stage, Capsida shall, in consultation with AbbVie, design, engineer and optimize vectors, using a selection of Capsids that includes certain existing Capsids or Reserved Capsids, the Expression Elements and tool cargo or AbbVie Cargo, in each case, selected by the JGC, for use in the Research Program for such Target for such Research Stage. Capsida will generate multiple Capsid-cargo constructs (\"Research Product Candidates\") for each Target for each Research Stage using various selections of Capsids, Expression Elements and cargo selected by the JGC so as to enable subsequent studies to assess efficacy, target engagement, immunogenicity and other parameters towards achieving the applicable Target Capsid Profile and Target Product Profile. Optimization of Research Product Candidates will involve assembly of cargo, capsids and Expression Elements selected, and could include evaluating various aspects such as promoter elements (e.g., ubiquitous and cell-type specific promoters), single stranded (ss) or self-complementary (sc) AAV packaging, codon optimization, and removal of CpG islands, so as to identify the best features to be incorporated in Research Product Candidates (including prototypes using rodent versions of the Capsid, as applicable). Capsida shall, as requested by AbbVie, provide AbbVie with: for fewer than 5E13 vector genomes per lot, no more than seventy-five (75) lots per year and for between 5E13 - 2E14 vector genomes per lot, no more than fifteen (15) lots of research grade vector per year of Research Product Candidates, including rodent versions as applicable, for α-syn and Tau to enable AbbVie to assess such Research Product Candidates in preclinical models. For each Target and Research Stage, the JGC shall determine the final Capsid-Expression Elements-cargo design.", "": "" }, { "Text": "2.3.8 Final Individual Capsid-Cargo Characterization. Based upon all Data Packages from the Screening Period, and upon selection of a final Capsid-Expression Elements-cargo design by the JGC, AbbVie shall have the right to select a single Capsid for final individual Capsid-cargo characterization and two (2) back-up Capsids (that, for clarity, will not be characterized unless the Primary Capsid therefor fails final individual Capsid-cargo characterization pursuant to this Section 2.3.8, in which case, upon AbbVie's request, the Parties shall use good faith efforts to agree to an amendment to the Research Plan, such agreement not to be unreasonably withheld, conditioned or delayed) for each Target for each Research Stage. Within thirty (30) days after AbbVie's receipt of all Data Packages for a Target for a Research Stage, AbbVie shall have the right to select for such Target for such Research Stage from among any Reserved Capsids, and any Capsids that resulted from activities under the Research Plan or for which the Selection Period has not yet expired, including for clarity, Selected Capsids or Reserved Capsids for other Targets or other Research Stages, one (1) lead Capsid (with respect to each Target and Research Stage, the \"Primary Capsid\") and two (2) back-up Capsids (with respect to each Target and Research Stage, the \"Back-Up Capsids\" and together with the Primary Capsid for such Target and Research Stage, the \"Selected Capsids\"). Each Selected Capsid shall be and remain exclusive to AbbVie as and to the extent set forth in Article 8, and Capsida shall not use or Exploit, or grant any Third Party the right to use or Exploit, any Selected Capsid in violation of the exclusivity and license grants set forth in Article 8. Without limiting Capsida's rights to use deselected Capsids as described above, after the end of the last Selection Period for the last Target from each Research Stage and after AbbVie has selected the Selected Capsids, Capsida shall be free to use all Capsids that are not Selected Capsids or Reserved Capsids (or otherwise subject to exclusivity under this Article 2 with respect to another Target or Research Stage) outside of this Agreement, subject to Section 8.8. Once AbbVie selects the Selected Capsids for a Target for a Research Stage, Capsida shall generate, optimize and validate the Primary Capsid for such Target and Research Stage in accordance with the applicable Research Plan, with an objective to confirm the tissue biodistribution, cell type specificity, transduction, and duration of expression, immunogenicity and establish a therapeutic index based on multi-dose non-GLP safety/toxicology study of the optimized final AbbVie Cargo - Primary Capsid (i.e., Research Product) to make the determination as to whether the Research Product meets the parameters of the Target Product Profile. AbbVie shall perform activities in support thereof as provided in the applicable Research Plan. Capsida shall further engineer and improve the Primary Capsid and Expression Elements to be combined with the AbbVie Cargo, for each Target for each Research Stage as necessary to generate a Research Product that is directed towards meeting the Target Product Profile for such Target for such Research Stage. The JGC shall periodically evaluate each Research Product from each Research Stage directed to such Target to determine whether such Research Product meets the applicable Target Product Profile. Upon completion of the Research Program with respect to a Target for a Research Stage, Capsida shall deliver to AbbVie the Final Data Package for such Target for such Research Stage in accordance with, and containing the information and other Know-How and accompanied with the materials required to be delivered with such Final Data Package as set forth in this Agreement and the applicable Plan (and such other information and Know-How (excluding any Highly Sensitive Know-How) in Capsida's Possession as AbbVie may reasonably request that is reasonably necessary to inform its decision as to whether to exercise the Option for such Target for such Research Stage).", "": "" }, { "Text": "2.3.9 Research Stage Two. If AbbVie exercises the Initial Capsid Program Option with respect to α-syn or Tau, Capsida shall conduct Optimization and Screening Activities to engineer, optimize, characterize, validate and deliver to AbbVie for each such Target with respect to which the Initial Capsid Program Option is exercised, Capsids that meet an additional target capsid profile for such Target(s) (each, an \"Additional Target Capsid Profile\") and Research Products that meet an additional target product profile for such Target (each, an \"Additional Target Product Profile\"). Each Additional Target Capsid Profile shall be prepared by the Parties and reviewed, revised, if appropriate, and approved by the JGC in accordance with this Section 2.3. Once AbbVie exercises the Initial Capsid Program Option with respect to a Target, the Optimization and Screening Activities for Research Stage One shall continue with respect to any other Targets for which the applicable Option Period has not ended. For clarity, Research Stage Two with respect to a Target may run concurrently with Research Stage One with respect to the other Target(s).", "": "" }, { "Text": "2.3.10 Existing Capsids. During the Capsid Screening Period, Capsida shall also provide AbbVie with Existing Capsids to enable AbbVie to assess whether they would be suitable for use in the Research Program or as Selected Capsids in accordance with the Capsid Program Research Plan; provided, however, that for purposes of such use, the Existing Capsids shall be deemed to be Transferred Materials and shall be subject to Section 2.8; provided, further, that (a) any Capsid generated from an Existing Capsid is not Transferred Material and (b) any Existing Capsid AbbVie selects to be a Selected Capsid would no longer be deemed to be Transferred Material, and, in each case ((a) and (b)), such Capsid shall not be subject to Section 2.8. Unless otherwise agreed by the Parties in writing, and without limiting Section 8.8, the Existing Capsids shall not be subject to the exclusivity restrictions set forth in this Section 2.3, but, for clarity, any Capsid generated using an Existing Capsid would be subject to such restrictions. For clarity, except as provided in Section 8.8, Capsida is not restricted from engaging in any activities, or granting any Third Party any rights with respect to any Existing Capsids at any time, and no rights to such Existing Capsids are being granted to AbbVie other than the right to conduct such assessments as outlined in the Capsid Program Research Plan. AbbVie shall have the right to include Existing Capsids in the Research Program and select an Existing Capsid as a Selected Capsid pursuant to this Section 2.3.", "": "" }, { "Text": "2.4 AbbVie Materials. AbbVie shall provide AbbVie Cargo for each Target and for each Research Stage (which may be the same as the AbbVie Cargo used in the other Research Stage) for use in the validation activities and shall use Commercially Reasonable Efforts to do so in accordance with the timelines set forth in the applicable Plans. For clarity, (a) while the AbbVie Cargo shall be used in the Research Program, AbbVie's efforts to develop or acquire AbbVie Cargo shall be conducted outside the Research Program and (b) while the Parties, through the JGC, may evaluate information and other Know-How relating to more than one (1) AbbVie Cargo under the Research Program, AbbVie shall have no obligation to provide more than one (1) AbbVie Cargo with respect to each Target. AbbVie shall have sole discretion as to the AbbVie Cargo delivered with respect to each Target under the Capsid Program Research Plan. The Parties, through the JGC, shall mutually agree on the specific AbbVie Cargo directed to TDP-43 to be included in the Primary Capsid under the Collaboration Program Research Plan (the \"ALS Cargo\"). AbbVie shall reasonably update Capsida on the progress of its efforts to develop or acquire AbbVie Cargo at each meeting of the JGC. AbbVie shall also have the right, but not the obligation, to provide: (i) AbbVie Cargo, including research tools, for use in the Optimization and Screening Activities; (ii) Expression Elements for use in the Research Program; or (iii) other biological materials or research tools for use in the Research Program (such AbbVie Cargo (and any other AbbVie Cargo provided under this Section 2.4), Expression Elements, materials and tools, together with any analogues, progeny, expression products, mutants, replicates, derivatives, modifications, enhancements and improvements thereof made by or on behalf of Capsida or its Affiliates, collectively the \"AbbVie Materials\"). Any failure of Capsida to perform in accordance with the applicable Research Plan shall not constitute a breach of Capsida's obligations hereunder to the extent such nonperformance is directly attributable to AbbVie's failure to provide any AbbVie Materials required under a Research Plan in a timely manner consistent with the applicable Research Plan. Capsida shall only use AbbVie Materials in accordance with the Permitted Uses for such materials as provided in Section 2.8. AbbVie shall provide Capsida with such information and other Know-How Controlled by AbbVie that is necessary or reasonably useful for Capsida to use AbbVie Material provided by AbbVie for its Permitted Uses. Without limiting Section 2.8, Capsida shall, and does hereby, assign to AbbVie, and shall cause its Affiliates and any Person that it or its Affiliates provides any AbbVie Materials to, to assign to AbbVie, any right, title or interest it or any of its Affiliates or any such Person may have in or to any AbbVie Materials, including any Patent, trade secret or other proprietary right with respect thereto.", "": "" }, { "Text": "2.5 Program Activities and Efforts. Except for those activities assigned to AbbVie in a Research Plan, Capsida shall be responsible for conducting the Research Program, including Manufacturing (including CMC Activities in support thereof) and supplying all Capsids (including Reserved Capsids and Selected Capsids), Expression Elements and Research Products, and shall do so at its sole cost and expense. Without limiting the foregoing, each Party shall conduct the activities assigned to it under the Research Plans and shall use Commercially Reasonable Efforts to do so within the timelines set forth therein. In implementing the Research Plans, Capsida shall use Commercially Reasonable Efforts to achieve the objectives of the Research Program for each Target and for each Research Stage.", "": "" }, { "Text": "2.6 Performance of Research Program and other Activities.", "": "" }, { "Text": "2.6.1 Compliance. All Research, Development, Manufacturing and Commercialization activities to be conducted by a Party under this Agreement shall be conducted in compliance with Applicable Law.", "": "" }, { "Text": "2.6.2 Subcontracting.", "": "" }, { "Text": "(a) Subject to Section 12.6.1, AbbVie shall have the right to engage Affiliates or Third Party subcontractors (including by appointing one (1) or more contract sales forces, co-promotion partners or Distributors) to perform any of its Research, Development, Manufacturing or Commercialization activities under this Agreement; provided that no such permitted subcontracting shall relieve AbbVie of any obligation hereunder and any act or omission of any such subcontractor in performing AbbVie's obligations hereunder shall constitute the act or omission of AbbVie for all purposes hereunder.", "": "" }, { "Text": "(b) Subject to Section 12.6.1, Capsida shall have the right to (sub)contract its Research, Development and Manufacturing activities under this Agreement to a Third Party to the extent expressly provided for in a Plan or with the approval of the JGC; provided that no such permitted subcontracting shall relieve Capsida of any obligation hereunder and any act or omission of any such (sub)contractor in performing Capsida's obligations hereunder shall constitute the act or omission of Capsida for all purposes hereunder.", "": "" }, { "Text": "(c) Any Affiliate or Third Party subcontractor to be engaged by a Party to perform a Party's obligations set forth in this Agreement shall meet the qualifications typically required by such Party for the performance of work similar in scope and complexity to the subcontracted activity. Any Party engaging an Affiliate or Third Party subcontractor hereunder shall remain responsible and obligated for such activities.", "": "" }, { "Text": "2.6.3 Records. Each Party shall, and shall require its Affiliates and shall use commercially reasonable efforts to require its permitted subcontractors to, maintain materially complete, current and accurate hard or electronic, as applicable, records of all work conducted and results achieved in the performance of the Research Program and the POC Plan (the \"Research Program Records\") and all results, data, developments and Know-How made in conducting such activities. Such records shall accurately reflect all such work done and results achieved in sufficient detail to verify compliance with its obligations under this Agreement and shall be in good scientific manner appropriate for applicable patent and regulatory purposes. Each Party shall ensure, and with respect to permitted subcontractors, shall use commercially reasonable efforts to ensure, that physical embodiments of data from activities under this Agreement (e.g., laboratory notebooks) record only Research and Development activities performed pursuant to this Agreement and not include or be commingled with records of activities outside the scope of this Agreement. AbbVie shall have the right, during normal business hours and upon reasonable notice but not more frequently than once per Calendar Year, using representatives selected by AbbVie and reasonably acceptable to Capsida, to inspect the Research Program Records of Capsida maintained pursuant to this Section 2.6.3 that is reasonably necessary to confirm Capsida's compliance with its Research and Development obligations under this Agreement and Capsida's readiness to Manufacture clinical supplies of Licensed Capsids and Licensed Products; provided that the representatives shall share such representatives' conclusions but not Capsida's actual Research Program Records with AbbVie and AbbVie and its representatives shall maintain any Confidential Information of Capsida in such records in confidence in accordance with Article 11 and shall not have access to any Capsida Confidential Information unrelated to this Agreement.", "": "" }, { "Text": "2.6.4 Information and Reports.", "": "" }, { "Text": "(a) On a monthly basis (or with such other frequency as may be agreed by the Parties), the Parties shall meet to discuss the progress of the Research Program and the CMC Activities since the last meeting, including any improvements, enhancements or modifications to the Capsida Platform or Capsida's Manufacturing technology in each case as relevant to the progress of the Research Program, Capsida's readiness to Manufacture clinical supplies of Licensed Capsids and Licensed Products, the schedule for generating General Capsid Libraries and Target-specific Capsid Libraries, the information and other Know-How regarding Existing Capsids that is agreed to be disclosed pursuant to the applicable Research Plan, Results from the Research Program, AbbVie's progress and timing on the generation of AbbVie Cargo and planned Research and Manufacturing activities with respect to the Research Program.", "": "" }, { "Text": "(b) At each meeting of the JGC for the Neurology Program (and in any event within thirty (30) days following the end of each Calendar Quarter), (i) Capsida shall provide to such JGC and AbbVie a reasonably detailed report regarding its Research activities under the Research Program, Results and access to or copies of reasonably detailed written reports of Research, Development activities hereunder, including all Results as agreed in the applicable Research Plan, as may be prepared by Capsida or as may reasonably requested by such JGC or AbbVie and (ii) AbbVie shall provide an update on AbbVie's progress and timing on the generation of AbbVie Cargo and relevant information (including reasonable supporting data as may be reasonably required by such JGC or Capsida) related to the AbbVie Cargo in support of the Research Program as further described in the Research Plan; and any activities performed by AbbVie under the Research Plan and associated Results as agreed in the applicable Research Plan, since the last such update. Each such report shall contain sufficient detail to enable such JGC to assess each Party's compliance with, and progress toward the goals of, each applicable Plan.", "": "" }, { "Text": "(c) In addition to the foregoing reports, Capsida promptly shall provide to AbbVie any copies of all material correspondence to and from any Regulatory Authority and copies of any material Regulatory Documentation related to the Capsida Platform to the extent related to Program Capsids, Research Products, Licensed Capsids, or Licensed Products, and supporting analyses and relevant analyzed data as may be reasonably requested by AbbVie from time to time.", "": "" }, { "Text": "2.7 Research Program Costs. Except as otherwise provided in the Capsid Program Research Plan or the Collaboration Program Research Plan, as applicable, each Party shall bear all costs and expenses incurred by or on behalf of it in the performance of the Research Program. For clarity, neither Party shall be deemed to be performing any activity on behalf of the other Party under this Agreement.", "": "" }, { "Text": "2.8 Transferred Materials. From time to time during the Research Program, each Party may transfer certain Transferred Materials to the other Party for use in the Research Program. Except for the licenses granted to the other Party pursuant to Section 8.1 and Section 8.2, the transferring Party shall retain all right, title and interest in and to the Transferred Materials and any derivatives, modifications, enhancements and improvements thereof generated by or on behalf of the other Party or any of its Affiliates, including any Patents, trade secret or other proprietary rights with respect thereto. Subject to Section 10.1.2, the transferee Party shall, and does hereby, assign to the transferring Party, and shall cause its Affiliates and any Person that it or its Affiliates provides any Transferred Materials to, to assign to the transferring Party, any right, title or interest it or any of its Affiliates or any such Person may have in or to any Transferred Materials, including any Patent, trade secret or other proprietary right with respect thereto. Each Party agrees that: (a) it shall not use the Transferred Materials for any purpose other than for the Permitted Uses; (b) it shall not make or attempt to make any analogues, progeny, expression products, mutants, replicates, derivatives, modifications, enhancements or improvements (except as expressly permitted under a Plan) to, or reverse engineer, the Transferred Materials; (c) it shall use the Transferred Materials in compliance with Applicable Law; (d) it shall not transfer any Transferred Materials to a Third Party in connection with the conduct of the Research Program unless such transfer is expressly identified as a Permitted Use in the applicable Plan; and (e) upon completion of a Plan for a Target, or the expiration or earlier termination of this Agreement, in each case, with respect to a Target or Licensed Product, or if otherwise requested by the transferring Party, the transferee Party shall, if and as instructed by the transferring Party, either destroy or return the all Transferred Materials except to the extent the transferee Party otherwise continues to have the right to use such Transferred Materials for Permitted Uses under this Agreement (e.g., for AbbVie to Exploit Licensed Capsids and Licensed Products and for Capsida to Exploit ALS Products under this Agreement). The transferee Party shall use the same degree of care and efficiency with respect to such Transferred Materials in the conduct of the Research Program as used by the transferee Party with respect to its own materials in the conduct of its own activities.", "": "" }, { "Text": "2.9 No Guarantee. Subject to Capsida's obligations to (a) complete the activities set forth in the Research Plans and (b) use Commercially Reasonable Efforts to do so on the timelines set forth therein and to achieve the objectives of the Research Program, Capsida provides no representation, warranty or guarantee that the objectives of the Research Program will be achieved, or that any other particular results will be achieved with respect to any Program Capsid or Research Product.", "": "" }, { "Text": "2.10 Specific Performance. Capsida acknowledges and agrees that Capsida's obligations under this Article 2 are unique and that AbbVie would not have entered into this Agreement in the absence of such obligations, and that any material breach or threatened material breach of this Article 2 by Capsida will result in irreparable injury to AbbVie for which damages will be not be an adequate remedy. Accordingly, AbbVie shall be entitled to specific performance of this Article 2.", "": "" }, { "Text": "ARTICLE 2A OPHTHALMOLOGY RESEARCH PROGRAM", "": "" }, { "Text": "2.11 General. The principal objectives of the Ophthalmology Research Program are for the Parties to collaborate using the Capsida Platform and Capsida Platform IP combined with AbbVie's capabilities in the ophthalmology space to generate, engineer, optimize, evaluate and deliver to AbbVie three (3) Capsids (one (1) lead and two (2) backups) that meet the Ophthalmology Target Capsid Profile for each Route of Administration and enable selective delivery of AbbVie Ophthalmology Cargo to the eye through such Route of Administration. Pursuant to the Ophthalmology Research Program, AbbVie shall have the right to select up to five (5) Reserved Ophthalmology Capsids for each Route of Administration, which AbbVie may elect to substitute with different Capsids based on the Results of the applicable Ophthalmology Research Stage, as further set forth in this Article 2A; provided that the maximum number of Reserved Ophthalmology Capsids per Route of Administration at one (1) time is five (5). The Ophthalmology Research Program shall include multiple screening and selection rounds as more fully described in this Article 2A and the Ophthalmology Research Plan. For each Route of Administration, Capsida shall, at its cost and expense (except as provided in clause (c)(ii) below with respect to clinical supply), (a) screen, optimize and characterize Capsids with cargo, including, as set forth in the Ophthalmology Research Plan, AbbVie Ophthalmology Cargo and any Expression Elements provided by AbbVie or selected by the JGC for the Ophthalmology Program for such Route of Administration; (b) produce material to validate assembled constructs that contain such optimized Capsid(s), including AbbVie Ophthalmology Cargo and Expression Elements for each such Route of Administration (each such assembled construct, an \"Ophthalmology Research Product\"), which for clarity may be Licensed Ophthalmology Products, through multiple iterations, including both before and after AbbVie's exercise of the applicable Ophthalmology Program Option up to GLP toxicology studies for each Licensed Ophthalmology Product, for use by AbbVie in connection with vector design and optimization for specific AbbVie Ophthalmology Cargo, as more fully described below, from which AbbVie shall have the right to select up to five (5) Capsids for such Route of Administration; (c) subject to Section 2.13.10, Manufacture and supply Capsids and Ophthalmology Research Products for use in connection with the Ophthalmology Research Program and (i) prior to AbbVie's exercise of the applicable Ophthalmology Program Option, develop processes (which, for clarity, prior to exercise of the applicable Option, does not include Ophthalmology Target-specific process development) for the Manufacture of, and supply, Capsids and Ophthalmology Research Products for use in the Ophthalmology Research Program; and (ii) after AbbVie's exercise of the applicable Ophthalmology Program Option, (A) develop processes for the Manufacture of, and supply to AbbVie, Capsids, Ophthalmology Research Products and Licensed Ophthalmology Products, in each case, for GLP toxicology studies and other IND-enabling studies required to support an IND in accordance with the Ophthalmology Research Plan (which, for clarity, includes process development for Manufacture of each Licensed Ophthalmology Product at the fifty (50) Liter scale); and (B) subject to a clinical supply agreement, Manufacture cGMP-grade materials for use by AbbVie in the future Development of Licensed Ophthalmology Products and clinical supply; and (d) provide AbbVie with consultation as needed throughout. Each Party shall conduct its obligations under the Ophthalmology Research Program using good scientific manner and in compliance with all Applicable Law. Without limiting Capsida's obligations in this Section 2.11, at least one (1) year prior to AbbVie's anticipated exercise of an Ophthalmology Program Option for a Route of Administration, the Parties shall meet and discuss a detailed plan and budget for Capsida's activities with respect to the development of processes for the Manufacture of, and supply to AbbVie of Capsids, Ophthalmology Research Products and Licensed Ophthalmology Products, in each case, for GLP toxicology studies and other IND-enabling studies with respect to the applicable Route of Administration. For clarity, lack of such a plan and budget (or agreement with respect thereto) shall not relieve Capsida of performing (at its cost and expense) the process development and supply activities set forth in this Section 2.11.", "": "" }, { "Text": "2.12 Ophthalmology Research Plan.", "": "" }, { "Text": "2.12.1 General. The Parties shall conduct activities under the Ophthalmology Research Program in accordance with a written research plan (the \"Ophthalmology Research Plan\"). The initial Ophthalmology Research Plan is attached hereto as Exhibit D. The Ophthalmology Research Plan shall detail (a) the responsibilities and activities of Capsida and AbbVie, (b) projected timelines for completion of such responsibilities and activities, including the appropriate sequencing for the pursuit of each Route of Administration and the timelines for delivery of each Final Ophthalmology Data Package for each Route of Administration, and an estimated budget therefor, (c) the Ophthalmology Target Capsid Profile for each Route of Administration, (d) the Results required to be included in each Data Package for each Route of Administration for each Ophthalmology Research Stage, including any requirements with respect to the format, to be delivered to the JGC for the Ophthalmology Program to demonstrate that the Ophthalmology Target Capsid Profile for each Route of Administration has been achieved or that the requirements for the applicable Ophthalmology Research Stage have been satisfied, (e) any biological materials or research tools to be provided by a Party for use by the other Party in the Ophthalmology Research Program (such materials and tools, together with, to the extent not constituting Cargo IP, Capsida Platform IP or Program IP, any analogues, progeny, expression products, mutants, replicates, derivatives, modifications, enhancements and improvements thereof generated by or on behalf of such Party or any of its Affiliates, collectively the \"Ophthalmology Transferred Materials\") and the Permitted Uses of the Ophthalmology Transferred Materials by the receiving Party (for clarity, the Capsids and Expression Elements shall not be Ophthalmology Transferred Materials) and (f) certain Capsids and other materials to be provided by Capsida to AbbVie.", "": "" }, { "Text": "2.12.2 Amendments to Ophthalmology Research Plan. The JGC for the Ophthalmology Program shall review the Ophthalmology Research Plan quarterly for the purpose of considering appropriate amendments thereto, and either Party, through its representatives on such JGC, may propose amendments to the Ophthalmology Research Plan at any time. Each Party may propose an amendment to the Ophthalmology Research Plan by submitting such proposed amendment in writing to the JGC for the Ophthalmology Program for review and approval, subject to the final decision-making process set forth in Section 7.2.3; provided, however, that (a) any amendment to the Ophthalmology Research Plan that would not (i) result in an increase to the corresponding budget estimate by more than ten percent (10%), (ii) increase the Screening Period by more than three (3) months, or (iii) make the use of Independent IP necessary, shall be subject to the review and approval by the applicable Working Group, and (b) any other amendment shall be considered promptly by each Party, and to be effective must be mutually agreed to by the Parties either in writing, or through such JGC as reflected in JGC meeting minutes signed by the Alliance Managers in accordance with Section 7.2.1, such agreement not to be unreasonably withheld, conditioned or delayed. The calculation of whether the costs of an amendment would exceed the corresponding budget shall be based on the FTE Costs (charged in accordance with Section 9.15) and the Out-of-Pocket Costs incurred by or on behalf of Capsida or any of its Affiliates. For clarity, operational, day-to-day decisions with respect to the implementation of the Ophthalmology Research Plan, including modifications described in Section 2.12.3, do not need to be submitted as an amendment, but (i) the imposition of any new or increased obligation of either Party to deliver any materials or perform any activities, (ii) any additional uses of any AbbVie Materials for purposes of performance of the Ophthalmology Research Plan, or (iii) changes with respect to requirements for (including the scope of results and data to be provided in) a Data Package or Final Ophthalmology Data Package, would require an amendment to the applicable section of the Ophthalmology Research Plan. For further clarity, budget overruns do not need to be submitted as an amendment to the Ophthalmology Research Plan and do not constitute or require amendments to the Ophthalmology Research Plan. Upon the Alliance Managers' signing the minutes of the JGC pursuant to Section 7.2.1 memorializing the agreement of the JGC to, or mutual written agreement by the Parties of, as applicable, an amendment to the Ophthalmology Research Plan, the Ophthalmology Research Plan shall be deemed to be amended by such amendment.", "": "" }, { "Text": "2.12.3 Modifications to the Ophthalmology Research Program. The Parties acknowledge and agree that the Ophthalmology Research Plan is not prescriptive, but instead sets forth the activities that the Parties reasonably expect as of the Effective Date will need to be performed to achieve the objectives of the Ophthalmology Research Program for each Route of Administration. Based on the further development of the Capsida Platform, including Capsida Platform IP, general learning in the field and the Results of the Ophthalmology Research Program, the specific activities under the Ophthalmology Research Program for each Route of Administration may need to be modified to achieve the objectives of the Ophthalmology Research Program for each Route of Administration. Changes in the sequence of activities, repetition of activities, or performance of activities of a similar nature, in each case to those set forth in the Ophthalmology Research Plan, shall be discussed and approved by the JGC for the Ophthalmology Program, such approval not to be unreasonably withheld, conditioned or delayed. The JGC for the Ophthalmology Program shall periodically evaluate the activities under the Ophthalmology Research Program to determine whether the objectives of the Ophthalmology Research Program for each Route of Administration, including specific timelines and research stages therein, are likely to be achieved and to determine what if any changes should be made to the Ophthalmology Research Plan to best do so.", "": "" }, { "Text": "2.13 Ophthalmology Research Program Activities.", "": "" }, { "Text": "2.13.1 Build and Platform Development. Pursuant to the Ophthalmology Research Plan, Capsida shall undertake preliminary activities focused on method validation, process optimization, preliminary screening and method development prior to non-human primate screening (the \"Build and Platform Development Research Stage\"). The Build and Platform Development Research Stage shall include activities to (a) develop and optimize methods for tissue processing and method development for AbbVie ocular tissues in Capsida's Platform and systems, based on AbbVie's supply of tissues in the form and at the times agreed by the Research Working Group; (b) test the feasibility of dosing alternate eyes to evaluate cross-ocular transduction and related safety and efficacy, based on AbbVie's supply of tissue dissection; (c) conduct early stage evaluation of different mutagenesis strategies and screening constructs with cargo agreed by the Research Working Group that could include representative AbbVie Ophthalmology Cargo; (d) undertake pre-test studies with libraries or Capsids to evaluate different engineering strategies or to establish benchmark Capsids, or both; and (e) process tissues from such study(ies) with Capsida's scRNAseq method and evaluate existing AbbVie scRNAseq data to develop bioinformatic tools for quantifying viral transcripts that can be mapped to particular cell types. It is the Parties' intention that Capsida's engineering and development activities shall be focused on AAV2 and AAV8; however, Capsida may consider or utilize alternative wild type serotypes based on applicable data and the recommendations of the Research Working Group, as contemplated in the Ophthalmology Research Plan.", "": "" }, { "Text": "2.13.2 Initial Library Screening (Round 1 and Round 2). In support of the initial library screenings of applicable Capsids to enable selection of Capsids for the IC, IVT and SCS Routes of Administration, pursuant to the Ophthalmology Research Plan, AbbVie would be responsible for performing certain in-life activities utilizing its own analysis methods and test cargo, including but not limited to (a) IC, IVT and SCS dosing, (b) ocular tissue dissection, and (c) methods for scRNAseq sample preparation on ocular samples if viable. Unless otherwise agreed by the Research Working Group or the JGC, in accordance with the Ophthalmology Research Plan, Capsida shall generate at least two (2) new de novo libraries of Capsids based on AAV2 and AAV8 serotypes for the Ophthalmology Research Program using the Capsida Platform, each comprising approximately thirty-four billion nucleic acid sequences for differentiated engineered Capsids (each, a \"General Ophthalmology Capsid Library\"). With respect to each Route of Administration, the General Ophthalmology Capsid Libraries will be screened through two (2) rounds of screening in non-human primates (the \"Initial Library Screening Research Stage\"). The first round of screening will involve a selection of Capsids from each General Ophthalmology Capsid Library. The second round of screening will be conducted using an enriched library derived from the first round of screening. After Capsida completes both rounds of initial library screening for each Route of Administration as contemplated in the Ophthalmology Research Plan, Capsida shall deliver to AbbVie the associated Data Package, as more fully described in the Ophthalmology Research Plan, and such other information and Know-How (excluding any Highly Sensitive Know-How) in Capsida's Possession as AbbVie may reasonably request within five (5) days of delivery of the Data Package that is reasonably necessary to inform its selection. If the Research Working Group recommends continued library screening based upon the Data Package for a Route of Administration, Capsida shall repeat the Initial Library Screening Research Stage for such Route of Administration as necessary until the Research Working Group recommends that the JGC for the Ophthalmology Research Program authorize progress to the Pooled Candidate Identification Studies for such Route of Administration. After Capsida delivers the applicable Data Package(s) to AbbVie, AbbVie shall have the right during each corresponding Ophthalmology Selection Period, to select up to five (5) Capsids per Route of Administration as \"Reserved Ophthalmology Capsids\". Capsida may generate additional de novo Capsid libraries; if Capsida screens any such library for activity in and directed to a Route of Administration during the Screening Period, such activity shall be included in the Ophthalmology Research Plan, such library shall be deemed to be a General Ophthalmology Capsid Library subject to Section 8.8, and Capsida shall deliver to AbbVie a Data Package detailing such screening and such other information and Know-How (excluding any Highly Sensitive Know-How) in Capsida's Possession as AbbVie may request that is reasonably necessary to make its decision with respect to such Data Package. Such General Ophthalmology Capsid Library shall be subject to this Section 2.13.2 and upon delivery of the Data Package, AbbVie shall have the right to designate one (1) or more Capsids from such General Ophthalmology Capsid Library as Reserved Ophthalmology Capsids during the corresponding Ophthalmology Selection Period for the applicable Route of Administration; provided that AbbVie deselects a corresponding number of Reserved Ophthalmology Capsids. With respect to each Route of Administration, based upon the Data Package from the Initial Library Screening Research Stage for such Route of Administration, the Research Working Group shall recommend to the JGC for the Ophthalmology Program whether to progress to the First Pooled Candidate Identification Studies Research Stage, or instead continue the Initial Library Screening Research Stage.", "": "" }, { "Text": "Each General Ophthalmology Capsid Library shall be and remain exclusive to AbbVie, and Capsida shall not use or Exploit (except to conduct the Ophthalmology Research Program), or grant any Third Party the right to use or Exploit, any Capsid in such General Ophthalmology Capsid Library, until the earlier of the end of the Ophthalmology Selection Period for such General Ophthalmology Capsid Library and the date that AbbVie selects five (5) Capsids from such General Ophthalmology Capsid Library as Reserved Ophthalmology Capsids for each Route of Administration for which such General Ophthalmology Capsid Library is applicable, subject to Section 8.8. For clarity, following AbbVie's selection of Reserved Ophthalmology Capsids as described above for each Route of Administration, and without limitation of AbbVie's right to select as a Reserved Ophthalmology Capsid after a later Ophthalmology Research Stage or as a Selected Ophthalmology Capsid for a Route of Administration, any Existing Capsid or Capsid that results from activities under the Ophthalmology Research Program or for which the Ophthalmology Selection Period has not yet expired, including for clarity, Selected Ophthalmology Capsids or Reserved Ophthalmology Capsids for other Routes of Administration, Capsida would retain the right to Exploit any deselected Capsid that is not a Reserved Ophthalmology Capsid or a Selected Ophthalmology Capsid or subject to exclusivity under this Article 2A outside of the AbbVie Indications, subject to Section 8.8.", "": "" }, { "Text": "For each new Reserved Ophthalmology Capsid with respect to a Route of Administration that AbbVie selects in excess of five (5) Reserved Ophthalmology Capsids for such Route of Administration under this Section 2.13.2, AbbVie shall deselect an existing Reserved Ophthalmology Capsid, such that AbbVie does not have more than five (5) Reserved Ophthalmology Capsids for such Route of Administration under this Section 2.13.2. For clarity, (x) AbbVie may adjust its selection of Reserved Ophthalmology Capsids after each Ophthalmology Research Stage based on the Results of such Ophthalmology Research Stage, and (y) without limitation of AbbVie's right to select as a Reserved Ophthalmology Capsid or a Selected Ophthalmology Capsid for a Route of Administration, any Existing Capsid or Capsid that results from activities under the Ophthalmology Research Program or for which the Ophthalmology Selection Period has not yet expired, including for clarity, Selected Ophthalmology Capsids or Reserved Ophthalmology Capsids for other Routes of Administration, Capsida shall be free to Exploit any deselected Capsid that is not (1) a Reserved Ophthalmology Capsid or a Selected Ophthalmology Capsid, (2) subject to, or would upon completion of an Ophthalmology Research Stage be subject to, an Ophthalmology Selection Period for another Route of Administration, or (3) subject to exclusivity under this Article 2A,in each case ((1)-(3)) subject to Section 8.8.", "": "" }, { "Text": "2.13.3 First Pooled Candidate Identification Studies. In accordance with the Ophthalmology Research Plan, the then-selected Reserved Ophthalmology Capsids, together with the other top performing Capsids identified in the Initial Library Screening Research Stage, and any applicable control Capsids from Capsida's engineering platform, shall be tested for each Route of Administration in initial pooled candidate identification studies in non-human primates or such other animal models as may be agreed to by the Parties to evaluate the performance of such Capsids (the \"First Pooled Candidate Identification Studies Research Stage\") with AbbVie Ophthalmology Cargo or test cargo. As further set forth in the Ophthalmology Research Plan, Capsida shall perform pooled candidate identification studies for each Route of Administration, the number of which shall depend on the number of libraries and the number of serotypes examined for each Route of Administration and the outcome of data analysis from the prior stages, as agreed to by the Research Working Group, under the First Pooled Candidate Identification Studies Research Stage. Capsida shall be responsible for the activities in respect of the First Pooled Candidate Identification Studies Research Stage, except for the activities for which AbbVie is designated as the responsible Party in the Ophthalmology Research Plan. Based upon the Data Package from the First Pooled Candidate Identification Studies Research Stage for a Route of Administration, (a) the Research Working Group shall recommend to the JGC for the Ophthalmology Program whether to progress to the Variant Optimization Research Stage and whether engineering efforts thereunder should be focused on a single serotype, or instead perform additional rounds of Initial Library Screening Research Stage screening, for such Route of Administration, and (b) on a Route of Administration-by-Route of Administration basis, AbbVie shall have the right during each corresponding Ophthalmology Selection Period, to adjust its selection of Reserved Ophthalmology Capsids that will progress to such next Ophthalmology Research Stage; provided that AbbVie does not have the right to designate more than five (5) Reserved Ophthalmology Capsids for each Route of Administration at any time.", "": "" }, { "Text": "2.13.4 Variant Optimization (Round 1 and Round 2). In accordance with the Ophthalmology Research Plan, the then-selected Reserved Ophthalmology Capsids, together with the other top performing Capsids identified in the First Pooled Candidate Identification Studies Research Stage will proceed to re-diversification and stabilizing library screening (the \"Variant Optimization Research Stage\"). Capsida will optimize such Capsids to generate at least one (1) re-diversification and stabilizing library for each Route of Administration using the latest Capsida Platform IP and as specified in the Ophthalmology Research Plan, unless otherwise agreed by the JGC for the Ophthalmology Program. Capsida shall provide each re-diversification and stabilizing library to be screened through at least two (2) rounds of screening in non-human primates with AbbVie responsible for the in-life portion of such screening. When screening for each re-diversification and stabilizing library, Capsida shall use libraries determined by the JGC for the Ophthalmology Program, in each case together with naturally occurring AAV2 and AAV8 as applicable and such other benchmark Capsids as such JGC may determine for each Route of Administration. In connection with each re-diversification and stabilizing library, Capsida shall deliver to AbbVie a Data Package after the second round of screening is complete and such other information and Know-How (excluding Highly Sensitive Know-How) in Capsida's Possession as AbbVie may reasonably request within five (5) days of delivery of the Data Package that is reasonably necessary to make its decision with respect to such Data Package. After Capsida completes all rounds of screening and delivers the associated Data Packages to AbbVie for each re-diversification and stabilization library for a Route of Administration, (a) the Research Working Group shall recommend to the JGC for the Ophthalmology Program whether to progress to the Secondary Pooled Ophthalmology CIS Research Stage, the Final Variant Optimization Research Stage, or the Final Pooled Ophthalmology CIS Research Stage or whether to continue the Variant Optimization Research Stage, for such Route of Administration and (b) on a Route of Administration-by-Route of Administration basis, AbbVie shall have the right during each corresponding Ophthalmology Selection Period, to adjust its selection of Reserved Ophthalmology Capsids that will progress to the next Ophthalmology Research Stage; provided that AbbVie does not have the right to designate more than five (5) Reserved Ophthalmology Capsids for each Route of Administration at any time.", "": "" }, { "Text": "2.13.5 Secondary Pooled Candidate Identification Studies. In accordance with the Ophthalmology Research Plan, for each applicable library (for each serotype and Route of Administration), unless otherwise agreed by the Research Working Group for the Ophthalmology Program, Capsida shall pool the then-selected Reserved Ophthalmology Capsids for such library together with other top-performing Capsids identified in the Variant Optimization Research Stage (and, if applicable, in the Initial Library Screening Research Stage) and benchmark Capsids (including AAV2 or AAV8, as applicable) identified and agreed upon by the JGC, as combined with an AbbVie Ophthalmology Cargo or test cargo and further evaluate the foregoing in non-human primates or such other animal models as may be agreed to by the Parties to evaluate the performance of such Capsids (with AbbVie responsible for the in-life portion of such studies) (the \"Secondary Pooled Ophthalmology CIS\" and such research stage the \"Secondary Pooled Ophthalmology CIS Research Stage\"). Capsida shall deliver to AbbVie a Data Package after the Secondary Pooled Ophthalmology CIS (and such other information and Know-How (excluding Highly Sensitive Know-How) in Capsida's Possession as AbbVie may reasonably request that is reasonably necessary to inform its selection) for each Route of Administration. Based upon the Data Package from the Secondary Pooled Ophthalmology CIS for the pooled capsids identified above on a Route of Administration-by-Route of Administration basis, the Research Working Group shall recommend to the JGC for the Ophthalmology Program, based on the results generated for each Route of Administration, whether to continue the Variant Optimization Research Stage or to progress to the Final Variant Optimization Research Stage and which capsids to further optimize in such Final Variant Optimization Research Stage or to continue the Variant Optimization Research Stage. AbbVie shall have the right on a Route of Administration-by-Route of Administration basis, after Capsida completes the Secondary Pooled Ophthalmology CIS Research Stage in accordance with the Ophthalmology Research Plan and delivers to AbbVie the resulting Data Package(s) as more fully described in the Ophthalmology Research Plan, to adjust its selection of Reserved Ophthalmology Capsids that will progress to the next Ophthalmology Research Stage; provided that AbbVie does not have the right to designate more than five (5) Reserved Ophthalmology Capsids for each Route of Administration at any time.", "": "" }, { "Text": "2.13.6 Final Variant Optimization (Round 1 and Round 2). In accordance with the Ophthalmology Research Plan, Capsida shall perform further Capsid optimization (the \"Final Variant Optimization Research Stage\") using the then-selected Reserved Ophthalmology Capsids for each Route of Administration, together with other top-performing Capsids identified under the Research activities for such Route of Administration combined with Capsida proprietary cargo. Capsida shall generate one (1) or more re-diversification and stabilizing libraries for each Route of Administration using AbbVie-selected Reserved Ophthalmology Capsids and the latest Capsida Platform IP, unless otherwise agreed by the JGC for the Ophthalmology Program. Capsida shall provide each such re-diversification and stabilizing library to be screened for each Route of Administration through up to two (2) rounds of screening in non-human primates (or such other animal models as may be agreed to by the Parties to evaluate the performance of such Capsids) or as determined by the Research Working Group based on the data with AbbVie responsible for the in-life portion of such screening. The first round of screening for each re-diversification and stabilizing library for each Route of Administration shall use the entire library, and the second round shall use an enriched library derived from the first round and such other benchmark Capsids as such JGC shall determine. Capsida shall deliver to AbbVie a Data Package after Capsida completes the second round of screening (as more fully described in the Ophthalmology Research Plan data deliverables table) for each Route of Administration and such other information and Know-How (excluding any Highly Sensitive Know-How) in Capsida's Possession as AbbVie may reasonably request within five (5) days of delivery of the Data Package that is reasonably necessary to make its decision with respect to such Data Package. With respect to each Route of Administration, based upon the Data Package from the Final Variant Optimization Research Stage studies for each applicable re-diversification and stabilizing library generated as part of the Final Variant Optimization Research Stage, the Research Working Group shall recommend to the JGC for the Ophthalmology Program whether to progress to the Final Pooled Ophthalmology CIS Research Stage or instead continue the Final Variant Optimization Research Stage. After Capsida completes all rounds of screening and delivers to AbbVie the associated Data Packages for each applicable re-diversification and stabilizing library generated as part of the Final Variant Optimization Research Stage, on a Route of Administration-by-Route of Administration basis, AbbVie shall have the right during each corresponding Ophthalmology Selection Period to adjust its selection of Reserved Ophthalmology Capsids that will progress to the next Ophthalmology Research Stage; provided that AbbVie does not have the right to designate more than five (5) Reserved Ophthalmology Capsids for each Route of Administration at any time.", "": "" }, { "Text": "2.13.7 Final Pooled Candidate Identification Studies. In accordance with the Ophthalmology Research Plan, following the Final Variant Optimization Research Stage for a Route of Administration, the JGC for the Ophthalmology Program shall identify and determine certain Capsids, including the then-selected Reserved Ophthalmology Capsids for such Route of Administration, top-performing Capsids identified under the Research activities for such Route of Administration, and other variants and benchmark Capsids (including AAV2 or AAV8, as applicable) that Capsida shall combine with AbbVie Ophthalmology Cargo or test cargo for the conduct of final pooled ophthalmology studies for such Route of Administration in non-human primates or such other animal models as may be agreed to by the Parties to evaluate the performance of such Capsids (with AbbVie responsible for the in-life portion of such studies) (the \"Final Pooled Ophthalmology CIS\" and such research stage the \"Final Pooled Ophthalmology CIS Research Stage\"). Capsida shall deliver to AbbVie a Data Package after such Final Pooled Ophthalmology CIS for each Route of Administration and such other information and Know-How (excluding Highly Sensitive Know-How) in Capsida's Possession as AbbVie may reasonably request that is reasonably necessary to make its decision with respect to such Data Package. On a Route of Administration-by-Route of Administration basis, AbbVie shall have the right, until twenty (20) days after Capsida both (a) completes the Final Pooled Ophthalmology CIS pursuant to this Section 2.13.7 for such Route of Administration in accordance with the Ophthalmology Research Plan and (b) delivers to AbbVie (i) the Data Packages for the Final Pooled Ophthalmology CIS Research Stage for such Route of Administration and such other information and Know-How in Capsida's Possession as AbbVie may reasonably request within five (5) Business Days after the delivery of the last such Data Package that is reasonably necessary to inform its selection of the Reserved Capsids to adjust its selection of Reserved Ophthalmology Capsids that will progress to the next Ophthalmology Research Stage for such Route of Administration; provided that AbbVie shall not designate more than five (5) Reserved Ophthalmology Capsids for each Route of Administration at any time.", "": "" }, { "Text": "2.13.8 Single Variant Characterization Studies. In accordance with and as more fully described in the Ophthalmology Research Plan, following the Final Pooled Ophthalmology CIS or as otherwise agreed by the JGC for a Route of Administration, AbbVie shall have the right to select up to five (5) Capsids to be evaluated for final individual Capsid characterization for such Route of Administration in a single variant characterization study (the \"Single Variant Characterization Studies\"). Each Party shall in accordance with the activities allocated to it in the applicable section of the Ophthalmology Research Plan for such Route of Administration, for each Route of Administration generate, optimize and validate the Selected Ophthalmology Capsid for such Route of Administration and other cargo directed to the Ophthalmology Targets, with an objective to determine whether the Ophthalmology Research Product meets the parameters of the Ophthalmology Target Capsid Profile. Within the applicable Ophthalmology Selection Period following delivery of the Final Ophthalmology Data Package for a Route of Administration, AbbVie shall have the right to select for such Route of Administration from among any Reserved Ophthalmology Capsids, and any Capsids that resulted from activities under this Ophthalmology Research Program or for which the Ophthalmology Selection Period has not yet expired, including for clarity, Selected Ophthalmology Capsids or Reserved Ophthalmology Capsids for other Routes of Administration, up to three (3) Capsids with respect to each Route of Administration (the \"Selected Ophthalmology Capsids\"). Each Selected Ophthalmology Capsid shall be and remain exclusive to AbbVie as and to the extent set forth in this Article 2A and Article 8, and Capsida shall not use or Exploit, or grant any Third Party the right to use or Exploit, any Selected Ophthalmology Capsid in violation of the exclusivity and license grants set forth in Article 8 or the exclusivity under this Article 2A. Without limiting Capsida's rights to Exploit deselected Capsids as described above, after the end of the last Ophthalmology Selection Period for the last Route of Administration and after AbbVie has selected the Selected Ophthalmology Capsids, Capsida shall be free to use all Capsids that are not Selected Ophthalmology Capsids or Reserved Ophthalmology Capsids outside of this Agreement, subject to Section 8.8. AbbVie shall perform activities in support thereof as provided in the Ophthalmology Research Plan. During the performance of the Ophthalmology Research Program, the JGC for the Ophthalmology Program shall periodically evaluate each Ophthalmology Research Product directed to such Route of Administration to determine whether such Ophthalmology Research Product meets the applicable Ophthalmology Target Capsid Profile. Subject to Section 3.2, upon completion of the Ophthalmology Research Program with respect to a Route of Administration, Capsida shall deliver to AbbVie the Final Ophthalmology Data Package for such Route of Administration and such other information and Know-How (excluding Highly Sensitive Know-How) in Capsida's Possession as AbbVie may reasonably request that is reasonably necessary to make its decision with respect to such Final Ophthalmology Data Package. In the event that Capsida is unable to deliver a Final Ophthalmology Data Package for a Route of Administration within the Screening Period, despite Capsida having performed all of the agreed-upon research activities assigned to Capsida under the Ophthalmology Research Plan in accordance with this Agreement, including the obligation to use Commercially Reasonable Efforts to meet the timelines and achieve the objectives of the Ophthalmology Research Program, and AbbVie does not designate Selected Ophthalmology Capsid(s) with respect to such Route of Administration, the rights and obligations of the Parties under the Amendment in respect of the Ophthalmology Research Program with respect to such Route of Administration shall cease.", "": "" }, { "Text": "2.13.9 Vector Design and Optimization.", "": "" }, { "Text": "(a) AbbVie may further engineer and improve the AbbVie Ophthalmology Cargo and Expression Elements for each Route of Administration outside of the Ophthalmology Research Program (i) as necessary to generate an Ophthalmology Research Product that is direct towards meeting the Ophthalmology Target Capsid Profile for such Route of Administration and (ii) if AbbVie exercises its Ophthalmology Program Option for such Route of Administration, to generate Licensed Ophthalmology Products for further Development and, in each case (i) and (ii), Capsida shall perform activities in support thereof as provided in the Ophthalmology Research Plan and this Section 2.13.9.", "": "" }, { "Text": "(b) In accordance with Ophthalmology Research Plan, from and after the initial Capsid library screening for a Route of Administration and until the later of (i) designation of the Selected Ophthalmology Capsids for such Route of Administration and (ii) if AbbVie exercises its Ophthalmology Program Option for such Route of Administration, AbbVie's selection of a Licensed Ophthalmology Product candidate for GLP toxicology studies for such Route of Administration, Capsida shall assist AbbVie through consultation to design, engineer and optimize vectors, using a selection of Capsids that includes certain existing Capsids, Reserved Ophthalmology Capsids or Selected Ophthalmology Capsids, the Expression Elements and tool cargo or AbbVie Ophthalmology Cargo, in each case, selected by AbbVie for the Ophthalmology Program and subject to Section 2.13.10, for use in the Ophthalmology Research Program for such Route of Administration and for evaluation by AbbVie. Capsida shall, subject to Section 2.13.10, thereafter generate multiple Capsid-cargo constructs (\"Ophthalmology Research Product Candidates\") for each Route of Administration using the various selections of Capsids, Expression Elements and cargo selected by AbbVie for the Ophthalmology Program so as to enable subsequent studies to assess efficacy, target engagement, immunogenicity and other parameters towards achieving the applicable Ophthalmology Target Capsid Profile. Optimization of Ophthalmology Research Product Candidates will involve assembly of cargo, capsids and Expression Elements selected by AbbVie to assist in evaluating various aspects such as promoter elements (e.g., ubiquitous and cell-type specific promoters), single stranded (ss) or self-complementary (sc) AAV packaging, codon optimization, and removal of CpG islands, so as to identify the best features to be incorporated in Ophthalmology Research Product Candidates. Capsida shall bear its own costs and expenses incurred in connection with Capsida's activities pursuant to this Section 2.13.9.", "": "" }, { "Text": "2.13.10 Research Study Materials Supply. Capsida shall in respect of the Ophthalmology Research Program and in addition to and without limiting (a) those provided for in Section 2.3.7 with respect to the Research Program and (b) supply for the activities contemplated by the Ophthalmology Research Stages in Sections 2.13.1 to 2.13.7, as requested by AbbVie, provide AbbVie with: for fewer than 5E13 vector genomes per lot, no more than seventy-five (75) lots per year and for between 5E13 - 2E14 vector genomes per lot, no more than fifteen (15) lots of research grade vector per year of Ophthalmology Research Product Candidates, including rodent versions as applicable, to enable AbbVie to assess such Ophthalmology Research Product Candidates in preclinical models. AbbVie shall provide Capsida with at least four (4) months' notice in the event AbbVie requires three (3) or more lots of 5E13 - 2E14 vector genomes per lot to be delivered within a thirty (30) day period.", "": "" }, { "Text": "2.13.12 Existing Capsids. During the Capsid Screening Period, Capsida shall also provide AbbVie with Existing Capsids to enable AbbVie to assess whether they would be suitable for use in the Ophthalmology Program or as Selected Ophthalmology Capsids in accordance with the Ophthalmology Research Plan; provided, however, that for purposes of such use, the Existing Capsids shall be deemed to be Transferred Materials and shall be subject to Section 2.19; provided, further, that (a) any Capsid generated from an Existing Capsid is not Transferred Material and (b) any Existing Capsid AbbVie selects to be a Selected Ophthalmology Capsid would no longer be deemed to be Transferred Material, and, in each case ((a) and (b)), such Capsid shall not be subject to Section 2.19. Unless otherwise agreed by the Parties in writing, and without limiting Section 8.8, the Existing Capsids shall not be subject to the exclusivity restrictions set forth in this Section 2.13, but, for clarity, any Capsid generated using an Existing Capsid would be subject to such restrictions. For clarity, except as provided in Section 8.8, Capsida is not restricted from engaging in any activities, or granting any Third Party any rights with respect to any Existing Capsids at any time, and no rights to such Existing Capsids are being granted to AbbVie other than the right to conduct such assessments as outlined in the Ophthalmology Research Plan. AbbVie shall have the right to include Existing Capsids in the Ophthalmology Program and select an Existing Capsid as a Selected Ophthalmology Capsid pursuant to this Section 2.13.", "": "" }, { "Text": "2.14 Target Selection.", "": "" }, { "Text": "2.14.1 Target List. AbbVie shall select Ophthalmology Targets of interest for the Ophthalmology Research Program from a rolling list of not more than twenty (20) Ophthalmology Targets (the \"Target List\"). The initial Target List is attached hereto as Exhibit E, and the JGC shall review the Target List every six (6) months to the extent any potential modifications by AbbVie are anticipated or pending for the Target List. AbbVie shall have the right, in its sole discretion, to modify the Target List by removing Ophthalmology Targets and adding new Ophthalmology Targets in accordance with Section 2.14.2. Any Ophthalmology Target on the Target List shall be subject to the exclusivity provisions set forth in Section 8.8.", "": "" }, { "Text": "2.14.2 Target List Substitutions. If AbbVie desires to substitute an Ophthalmology Target on the Target List with a different Ophthalmology Target that is not on the Target List, AbbVie shall notify Capsida in writing. Promptly (and in any event within fifteen (15) Business Days) after such notice by AbbVie, Capsida shall notify AbbVie in writing if the proposed Ophthalmology Target is, at the time of such notice by AbbVie, (a) subject to an ongoing and continuous bona fide Capsida research or development program, where, subject to Section 8.8, Capsida is actively conducting, pursuant to a written plan, discovery activities with respect to one (1) or more products that are directed to such proposed Ophthalmology Target and expending stage-appropriate resources for that program, as evidenced by written documentation attesting to same from Capsida; or (b) subject to Third Party rights, which would conflict with AbbVie's rights contemplated under the Ophthalmology Program Options if such Ophthalmology Target were a Final Selected Ophthalmology Target, (i) pursuant to an executed definitive agreement between Capsida and such Third Party or (ii) as contemplated in a draft definitive agreement that is, at such point in time, under ongoing bona fide negotiations between Capsida and such Third Party. If Capsida does not notify AbbVie within such fifteen (15) Business Day period that the circumstances in either clause (a) or (b) apply, the proposed Ophthalmology Target shall be added to the Target List and the substituted Ophthalmology Target shall be removed from the Target List and the Parties shall memorialize the updated Target List in writing. If Capsida notifies AbbVie within such fifteen (15) Business Day period that the circumstances in either clause (a) or (b) apply, such Ophthalmology Target shall not be added to the Target List except as set forth in the following sentence. If either clause (b)(i), or (b)(ii) apply, Capsida shall, if requested by AbbVie, use good faith efforts to carve out from any such definitive agreement, and, in the case of (a), (b)(i) or (b)(ii), obtain Capsida board approval to expressly reserve for AbbVie under this Agreement, exclusive rights with respect to the Routes of Administration and, in addition, the AbbVie Indications, in each case, with respect to such proposed Ophthalmology Target (the \"AbbVie Reserved Field\") and if Capsida successfully carves out and reserves for AbbVie the AbbVie Reserved Field with respect to the proposed Ophthalmology Target, and in any event, if requested by AbbVie with respect to a proposed Ophthalmology Target that is subject to clause (a), Capsida shall negotiate in good faith with AbbVie to include such proposed Ophthalmology Target in this Agreement but only with respect to the AbbVie Reserved Field, and if such Ophthalmology Target is included, (1) Capsida shall not be in violation of the exclusivity obligations set forth in Section 8.8.1(d) for activities with respect to such Ophthalmology Target outside of the AbbVie Reserved Field during the time such Ophthalmology Target is on the Target List and (2) if such Ophthalmology Target is selected as a Final Selected Ophthalmology Target, the references to \"Field\" in the exclusive rights granted by Capsida to AbbVie under Section 8.1.4 and Section 8.1.5 to Exploit Licensed Ophthalmology Capsids for use with such Final Selected Ophthalmology Target and corresponding Licensed Ophthalmology Products shall be deemed to refer instead to the \"AbbVie Reserved Field\" and Capsida shall not be in violation of the exclusivity obligations set forth in Section 8.8.1(c) for activities with respect to such Final Selected Ophthalmology Targets outside of the AbbVie Reserved Field. No Ophthalmology Target shall be removed from the Target List unless and until the replacement Ophthalmology Target is added in accordance with the procedures in this Section 2.14.2. For clarity, if AbbVie removes an Ophthalmology Target from the Target List, AbbVie would only be permitted to add it back to the Target List pursuant to the procedures set forth in this Section 2.14.2. For further clarity, Capsida has the right to pursue any Ophthalmology Target that is not on the Target List and is not a Selected Ophthalmology Target or a Final Selected Ophthalmology Target subject to Article 8.", "": "" }, { "Text": "2.14.3 Target Selection. AbbVie shall have twenty-four (24) months following delivery of a Final Ophthalmology Data Package for the first Route of Administration to select from the Target List its initial three (3) Ophthalmology Targets (each such selected Ophthalmology Target, a \"Selected Ophthalmology Target\"). After selection of the initial three (3) Selected Ophthalmology Targets, and at any time within (a) the later of (i) the twenty-four (24) month period following initiation of testing of Ophthalmology Research Product Candidates for a Route of Administration after AbbVie's exercise of its Ophthalmology Program Option for such Route of Administration in non-human primates for the first initial Selected Ophthalmology Target, and (ii) the twelve (12) month period following delivery of a Final Ophthalmology Data Package for the last Route of Administration, or, if earlier, (b) seventy-eight (78) months after the Effective Date, AbbVie shall have the right, in its sole discretion, to substitute each Selected Ophthalmology Target with another Ophthalmology Target from the Target List multiple times for any reason (e.g., safety, efficacy, technical feasibility). On or prior to the date of expiration of such period, AbbVie shall notify Capsida of AbbVie's final three (3) Selected Ophthalmology Targets (each, a \"Final Selected Ophthalmology Target\") (which such Final Selected Ophthalmology Targets shall be selected by AbbVie in AbbVie's sole discretion); provided that in the absence of such notification, the last three (3) Selected Ophthalmology Targets designated by AbbVie shall be deemed the Final Selected Ophthalmology Targets.", "": "" }, { "Text": "2.15 AbbVie Materials. As set forth in the Ophthalmology Research Plan, AbbVie shall have the right to provide AbbVie Ophthalmology Cargo or research tools for each Route of Administration (which may be the same as the AbbVie Ophthalmology Cargo used for other Routes of Administration) for use in the validation activities and shall use Commercially Reasonable Efforts to do so in accordance with the timelines set forth in the applicable section of the Ophthalmology Research Plan. For clarity, (a) while the AbbVie Ophthalmology Cargo may be used in the Ophthalmology Research Program, AbbVie's efforts to develop or acquire AbbVie Ophthalmology Cargo shall be conducted outside the Ophthalmology Research Program and (b) while the Parties, through the JGC for the Ophthalmology Program, may evaluate information and other Know-How relating to more than one (1) AbbVie Ophthalmology Cargo or research tool under the Ophthalmology Research Program, AbbVie shall have no obligation to provide more than one (1) AbbVie Ophthalmology Cargo or research tool. Other than as set forth in the Ophthalmology Research Plan, AbbVie shall have sole discretion as to the AbbVie Ophthalmology Cargo or research tools delivered for use under the Ophthalmology Research Plan. AbbVie shall reasonably update Capsida on the progress of its efforts to develop or acquire AbbVie Ophthalmology Cargo at each meeting of the JGC for the Ophthalmology Program. AbbVie shall also have the right, but not the obligation, to provide: (i) AbbVie Ophthalmology Cargo, including research tools, for use in the Ophthalmology Research Program; (ii) Expression Elements for use in the Ophthalmology Research Program (provided, however, AbbVie shall provide 3' UTR elements for single cell RNA sequencing and any cell-type specific promoters); or (iii) other biological materials or research tools for use in the Ophthalmology Research Program (such AbbVie Ophthalmology Cargo (and any other AbbVie Ophthalmology Cargo provided under this Section 2.15), Expression Elements, materials and tools, together with any analogues, progeny, expression products, mutants, replicates, derivatives, modifications, enhancements and improvements thereof made by or on behalf of Capsida or its Affiliates, collectively the \"AbbVie Ophthalmology Materials\"). Any failure of Capsida to perform in accordance with the Ophthalmology Research Plan shall not constitute a breach of Capsida's obligations hereunder to the extent such nonperformance is directly attributable to AbbVie's failure to provide any AbbVie Ophthalmology Materials required under the Ophthalmology Research Plan in a timely manner consistent with the applicable section of the Ophthalmology Research Plan. Capsida shall only use AbbVie Ophthalmology Materials in accordance with the Permitted Uses for such materials as provided in Section 2.19. AbbVie shall provide Capsida with such information and other Know-How Controlled by AbbVie that is necessary or reasonably useful for Capsida to use AbbVie Ophthalmology Material provided by AbbVie for its Permitted Uses. Without limiting Section 2.19, Capsida shall, and does hereby, assign to AbbVie, and shall cause its Affiliates and any Person that it or its Affiliates provides any AbbVie Ophthalmology Materials to, to assign to AbbVie, any right, title or interest it or any of its Affiliates or any such Person may have in or to any AbbVie Ophthalmology Materials, including any Patent, trade secret or other proprietary right with respect thereto.", "": "" }, { "Text": "2.16 Program Activities and Efforts. Except for those activities assigned to AbbVie in the Ophthalmology Research Plan or herein, Capsida shall be responsible for conducting the Ophthalmology Research Program, including Manufacturing (including CMC Activities in support thereof) and supplying all Capsids (including Reserved Ophthalmology Capsids and Selected Ophthalmology Capsids) and Ophthalmology Research Products and shall do so at its sole cost and expense. Without limiting the foregoing, each Party shall conduct the activities assigned to it under the Ophthalmology Research Plan and shall use Commercially Reasonable Efforts to do so within the timelines set forth therein. In implementing the Ophthalmology Research Plan, each Party shall use Commercially Reasonable Efforts to achieve the objectives of the Ophthalmology Research Program for each Route of Administration.", "": "" }, { "Text": "2.17 Performance of Research Program and other Activities.", "": "" }, { "Text": "2.17.1 Compliance. All Research, Development, Manufacturing and Commercialization activities to be conducted by a Party under this Agreement shall be conducted in compliance with Applicable Law.", "": "" }, { "Text": "2.17.2 Subcontracting.", "": "" }, { "Text": "(a) Subject to Section 12.6.1, AbbVie shall have the right to engage Affiliates or Third Party subcontractors (including by appointing one (1) or more contract sales forces, co-promotion partners or Distributors) to perform any of its Research, Development, Manufacturing or Commercialization activities under this Agreement; provided that no such permitted subcontracting shall relieve AbbVie of any obligation hereunder and any act or omission of any such subcontractor in performing AbbVie's obligations hereunder shall constitute the act or omission of AbbVie for all purposes hereunder.", "": "" }, { "Text": "(b) Subject to Section 12.6.1, Capsida shall have the right to (sub)contract its Research, Development and Manufacturing activities under this Agreement to a Third Party to the extent expressly provided for in a Plan or with the approval of the applicable JGC; provided that no such permitted subcontracting shall relieve Capsida of any obligation hereunder and any act or omission of any such (sub)contractor in performing Capsida's obligations hereunder shall constitute the act or omission of Capsida for all purposes hereunder.", "": "" }, { "Text": "(c) Any Affiliate or Third Party subcontractor to be engaged by a Party to perform a Party's obligations set forth in this Agreement shall meet the qualifications typically required by such Party for the performance of work similar in scope and complexity to the subcontracted activity. Any Party engaging an Affiliate or Third Party subcontractor hereunder shall remain responsible and obligated for such activities.", "": "" }, { "Text": "2.17.3 Records. Each Party shall, and shall require its Affiliates and shall use commercially reasonable efforts to require its permitted subcontractors to, maintain materially complete, current and accurate hard or electronic, as applicable, records of all work conducted and results achieved in the performance of the Ophthalmology Research Program (the \"Ophthalmology Research Program Records\") and all results, data, developments and Know-How made in conducting such activities. Such records shall accurately reflect all such work done and results achieved in sufficient detail to verify compliance with its obligations under this Agreement and shall be in good scientific manner appropriate for applicable patent and regulatory purposes. Each Party shall ensure, and with respect to permitted subcontractors, shall use commercially reasonable efforts to ensure, that physical embodiments of data from activities under this Agreement (e.g., laboratory notebooks) record only Research and Development activities performed pursuant to this Agreement and not include or be commingled with records of activities outside the scope of this Agreement. AbbVie shall have the right, during normal business hours and upon reasonable notice but not more frequently than once per Calendar Year, using representatives selected by AbbVie and reasonably acceptable to Capsida, to inspect the Ophthalmology Research Program Records of Capsida maintained pursuant to this Section 2.17.3 that is reasonably necessary to confirm Capsida's compliance with its Research and Development obligations under this Agreement and Capsida's readiness to Manufacture clinical supplies of Licensed Ophthalmology Capsids and Licensed Ophthalmology Products; provided that the representatives shall share such representatives' conclusions but not Capsida's actual Ophthalmology Research Program Records with AbbVie and AbbVie and its representatives shall maintain any Confidential Information of Capsida in such records in confidence in accordance with Article 11 and shall not have access to any Capsida Confidential Information unrelated to this Agreement.", "": "" }, { "Text": "2.17.4 Information and Reports.", "": "" }, { "Text": "(a) On a monthly basis (or with such other frequency as may be agreed by the Parties), the Parties shall meet to discuss the progress of the Research Program and the CMC Activities since the last meeting, including any improvements, enhancements or modifications to the Capsida Platform or Capsida's Manufacturing technology in each case as relevant to the progress of the Research Program, Capsida's readiness to Manufacture clinical supplies of Licensed Ophthalmology Capsids and Licensed Ophthalmology Products, the schedule for generating General Ophthalmology Capsid Libraries and other libraries, including, as applicable, Route of Administration-specific Capsid libraries, the information and other Know-How that is agreed to be disclosed pursuant to the Ophthalmology Research Plan, Results from the Ophthalmology Research Program, AbbVie's progress and timing on the generation of AbbVie Ophthalmology Cargo and planned Research and Manufacturing activities with respect to the Ophthalmology Research Program.", "": "" }, { "Text": "(b) At each meeting of the JGC for the Ophthalmology Program (and in any event within thirty (30) days following the end of each Calendar Quarter), (i) Capsida shall provide to such JGC and AbbVie a reasonably detailed report regarding its Research activities under the Ophthalmology Research Program, Results and access to or copies of reasonably detailed written reports of Research, Development activities hereunder, including all Results as agreed in the Ophthalmology Research Plan, as may be prepared by Capsida or as may reasonably requested by such JGC or AbbVie and (ii) AbbVie shall provide an update on AbbVie's progress and timing on the generation of AbbVie Ophthalmology Cargo and relevant information (including reasonable supporting data as may be reasonably required by such JGC or Capsida) related to the AbbVie Ophthalmology Cargo in support of the Ophthalmology Research Program as further described in the Ophthalmology Research Plan; and any activities performed by AbbVie under the Ophthalmology Research Plan and associated Results as agreed in the Ophthalmology Research Plan, since the last such update. Each such report shall contain sufficient detail to enable the JGC for the Ophthalmology Program to assess each Party's compliance with, and progress toward the goals of, each applicable Plan.", "": "" }, { "Text": "(c) In addition to the foregoing reports, Capsida promptly shall provide to AbbVie any copies of all material correspondence to and from any Regulatory Authority and copies of any material Regulatory Documentation related to the Capsida Platform to the extent related to Ophthalmology Program Capsids, Ophthalmology Research Products, Licensed Ophthalmology Capsids, or Licensed Ophthalmology Products, and supporting analyses and relevant analyzed data as may be reasonably requested by AbbVie from time to time.", "": "" }, { "Text": "2.18 Ophthalmology Research Program Costs. Except as otherwise provided in the Ophthalmology Research Plan, as applicable, each Party shall bear all costs and expenses incurred by or on behalf of it in the performance of the Ophthalmology Research Program. For clarity, neither Party shall be deemed to be performing any activity on behalf of the other Party under this Agreement.", "": "" }, { "Text": "2.19 Transferred Materials. From time to time during the Ophthalmology Research Program, each Party may transfer certain Transferred Materials to the other Party for use in the Ophthalmology Research Program. Except for the licenses granted to the other Party pursuant to Section 8.1 and Section 8.2, the transferring Party shall retain all right, title and interest in and to the Transferred Materials and any derivatives, modifications, enhancements and improvements thereof generated by or on behalf of the other Party or any of its Affiliates, including any Patents, trade secret or other proprietary rights with respect thereto. Subject to Section 10.1.2, the transferee Party shall, and does hereby, assign to the transferring Party, and shall cause its Affiliates and any Person that it or its Affiliates provides any Transferred Materials to, to assign to the transferring Party, any right, title or interest it or any of its Affiliates or any such Person may have in or to any Transferred Materials, including any Patent, trade secret or other proprietary right with respect thereto. Each Party agrees that: (a) it shall not use the Transferred Materials for any purpose other than for the Permitted Uses; (b) it shall not make or attempt to make any analogues, progeny, expression products, mutants, replicates, derivatives, modifications, enhancements or improvements (except as expressly permitted under a Plan) to, or reverse engineer, the Transferred Materials; (c) it shall use the Transferred Materials in compliance with Applicable Law; (d) it shall not transfer any Transferred Materials to a Third Party in connection with the conduct of the Research Program unless such transfer is expressly identified as a Permitted Use in the applicable Plan; and (e) upon completion of a Plan for a Target, or the expiration or earlier termination of this Agreement, in each case, with respect to a Target or Licensed Product, or if otherwise requested by the transferring Party, the transferee Party shall, if and as instructed by the transferring Party, either destroy or return all Transferred Materials except to the extent the transferee Party otherwise continues to have the right to use such Transferred Materials for Permitted Uses under this Agreement (e.g., for AbbVie to Exploit Licensed Ophthalmology Capsids and Licensed Ophthalmology Products under this Agreement). The transferee Party shall use the same degree of care and efficiency with respect to such Transferred Materials in the conduct of the Ophthalmology Research Program as used by the transferee Party with respect to its own materials in the conduct of its own activities.", "": "" }, { "Text": "2.20 No Guarantee. Subject to Capsida's obligations to (a) complete the activities set forth in the Ophthalmology Research Plan and (b) use Commercially Reasonable Efforts to do so on the timelines set forth therein and to achieve the objectives of the Ophthalmology Research Program, Capsida provides no representation, warranty or guarantee that the objectives of the Ophthalmology Research Program will be achieved, or that any other particular results will be achieved with respect to any Ophthalmology Program Capsid or Ophthalmology Research Product.", "": "" }, { "Text": "2.21 Specific Performance. Capsida acknowledges and agrees that Capsida's obligations under this Article 2A are unique and that AbbVie would not have entered into this Agreement in the absence of such obligations, and that any material breach or threatened material breach of this Article 2A by Capsida will result in irreparable injury to AbbVie for which damages will be not be an adequate remedy. Accordingly, AbbVie shall be entitled to specific performance of this Article 2A.", "": "" }, { "Text": "ARTICLE 3 EXCLUSIVE OPTIONS", "": "" }, { "Text": "3.1 Option Grants.", "": "" }, { "Text": "3.1.1 Initial Capsid Program Options. Capsida hereby grants to AbbVie fully paid-up, irrevocable and exclusive options to obtain an exclusive right and license (even as to Capsida and its Affiliates) pursuant to Section 8.1.4 to Exploit Licensed Products in the Field in the Territory for (a) α-syn (the \"α-syn Program Option\") and (b) Tau (the \"Tau Program Option\"), in each case ((a) and (b)) that contain one or more Selected Capsids from Research Stage One (the \"Capsid Exclusive License\").", "": "" }, { "Text": "3.1.2 Additional Capsid Program Option. Effective upon AbbVie's exercise of the Initial Capsid Program Option with respect to each of α-syn and Tau, Capsida hereby grants to AbbVie a fully paid-up, irrevocable and exclusive option (each, an \"Additional Capsid Program Option\") to expand the Capsid Exclusive License to include Licensed Products in the Field in the Territory that contain one or more Selected Capsids from Research Stage Two for the applicable Target.", "": "" }, { "Text": "3.1.3 Collaboration Program Option. Capsida hereby grants to AbbVie a fully paid-up, irrevocable and exclusive option (the \"Collaboration Program Option\") to obtain an exclusive right and license (even as to Capsida and its Affiliates) pursuant to Section 8.1.4 to Exploit Licensed Products in the Field in the Territory that contain one or more Collaboration Program Capsids.", "": "" }, { "Text": "3.1.4 Ophthalmology Program Options. Capsida hereby grants to AbbVie fully paid-up, irrevocable and exclusive options to obtain an exclusive right and license (even as to Capsida and its Affiliates) pursuant to Section 8.1.4 to Exploit Licensed Ophthalmology Capsids and corresponding Licensed Ophthalmology Products in the Field in the Territory, (a) such option with respect to IVT, the \"IVT Option\"; (b) such option with respect to SCS, the \"SCS Option\"; and (c) such option with respect to IC, the \"IC Option\".", "": "" }, { "Text": "3.2 Delivery of Final Data Packages. Promptly following delivery of the Final Data Package for each Target and for each Research Stage or in respect of each Route of Administration for the Final Ophthalmology Data Package for such Route of Administration, as applicable, Capsida shall provide AbbVie with electronic access to all Results pursuant to the agreed upon Capsid Program Research Plan, Collaboration Program Research Plan or Ophthalmology Research Plan with respect thereto (to the extent not previously provided). In addition, Capsida promptly shall make available such other information and Know-How (excluding any Highly Sensitive Know-How) in Capsida's Possession as AbbVie may reasonably request that is reasonably necessary in order to make an informed decision regarding whether to exercise the α-syn Program Option, the Tau Program Option, any Additional Capsid Program Option, the Collaboration Program Option, the IVT Option, the SCS Option or the IC Option, as applicable; provided, that (a) AbbVie shall not have a right to require that Capsida perform any Research activities with respect to any Selected Capsid or Selected Ophthalmology Capsid, as applicable, that is not set forth in the applicable Plan, and (b) no Option Period shall be extended as a result of any request by AbbVie for any such information and Know-How after the date that is fifteen (15) Business Days after delivery of the applicable Final Data Package or Final Ophthalmology Data Package.", "": "" }, { "Text": "3.3 Option Exercise. AbbVie shall have the right, in its sole discretion, to exercise the α-syn Program Option (and if it exercises the α-syn Program Option, an Additional Capsid Program Option with respect to α-syn), the Tau Program Option (and if it exercises the Tau Program Option, an Additional Capsid Program Option with respect to Tau), the Collaboration Program Option, the IVT Option, the SCS Option and the IC Option in each case during the applicable Option Period, by delivering an Exercise Notice to Capsida specifying the Option(s) being exercised. Upon issuing the Exercise Notice for the α-syn Program Option or the Tau Program Option, as applicable, the Selected Capsids for such Target shall become \"Licensed Capsid Program Capsids\", and α-syn or Tau, as applicable, shall become a \"Licensed Target\". Upon issuing the Exercise Notice for an Additional Capsid Program Option the Selected Capsids for the applicable Target shall become Licensed Capsid Program Capsids. Upon issuing the Exercise Notice for the Collaboration Program Option, the Collaboration Program Capsids shall become \"Licensed Collaboration Program Capsids\" and TDP-43 shall become a Licensed Target. Upon issuing the Exercise Notice for the IVT Option, the SCS Option or the IC Option, the Selected Ophthalmology Capsids for such Route of Administration shall become \"Licensed Ophthalmology Capsids\". Notwithstanding the foregoing timing for delivery of the applicable Exercise Notice in respect of an Ophthalmology Program Option, in the event that data, information or Results in respect of a different Route of Administration is generated prior to the end of the applicable Ophthalmology Selection Period, which would, in AbbVie's reasonable opinion, affect its decision whether to exercise the applicable Ophthalmology Program Option, AbbVie has the right to extend the time period to exercise the applicable Ophthalmology Program Option until the end of the Ophthalmology Program Option Period for such different Route of Administration.", "": "" }, { "Text": "3.4 Capsida Transition Obligations on Option Exercise. On the applicable Option Exercise Date (except as otherwise specified in this Section 3.4 and subject to the proviso at the end of this Section 3.4 in the case of ALS Products), without additional consideration to Capsida:", "": "" }, { "Text": "3.4.1 Manufacture. Upon AbbVie's request after the exercise of an Option, Capsida shall, subject to Section 3.5, assign or sublicense to AbbVie any agreements (including any Qualified CMO Agreement) to the extent such agreements relate to the Research, Development or Manufacture of any Licensed Product or Licensed Ophthalmology Product, as applicable, to which Capsida or any of its Affiliates is a party. To the extent any such agreement is not assignable or sublicensable, Capsida shall, on AbbVie's request, (a) use Commercially Reasonable Efforts to enable AbbVie's entry into similar agreements with the applicable counterparties and (b) until any such similar agreement is executed, provide AbbVie with all applicable rights and benefit under such agreement, in each case ((a) and (b)) so as to permit AbbVie to exercise its rights under Article 5; provided, further, that to the extent any Licensed Product or Licensed Ophthalmology Product, as applicable, is necessary for Capsida to fulfill its obligations under any Research Plan or Ophthalmology Research Plan, as applicable, that is ongoing after the applicable Option Exercise Date, if such Licensed Product or Licensed Ophthalmology Product is supplied under an agreement assigned to AbbVie, AbbVie shall use Commercially Reasonable Efforts to promptly provide to Capsida such quantities of such Licensed Product or Licensed Ophthalmology Product that are necessary for Capsida to fulfill such obligations, unless and until AbbVie agrees to assume, or otherwise relieves Capsida of, such obligations in writing or Capsida completes such Research activities;", "": "" }, { "Text": "3.4.2 Information; Materials. Capsida shall transfer to AbbVie copies of all data (excluding raw sequence data except for Selected Capsids or Selected Ophthalmology Capsids), reports, records, materials (including any assays, reagents, research tools and quantities of each Research Product or Ophthalmology Research Product, as applicable) and other information arising out of or used in (a) the Research Program relating to the Selected Capsids for the applicable Licensed Target(s) and Research Stage, or (b) the Ophthalmology Research Program relating to the Selected Ophthalmology Capsids for the applicable Route of Administration, or, in each case ((a) and (b)) any Manufacturing activities with respect thereto, including all non-clinical data relating to any Licensed Capsid, Licensed Product, Licensed Ophthalmology Capsid, or Licensed Ophthalmology Product, as applicable, and all safety data resulting from (i) the Research Program relating to the applicable Licensed Target(s) and Research Stage, or (ii) the Ophthalmology Research Program relating to the applicable Route of Administration, as well as, in each case ((i) and (ii)) any chemistry, manufacturing and controls (CMC) or other Manufacturing data generated in connection with the foregoing;", "": "" }, { "Text": "3.4.3 Quality and Safety Agreements. Capsida and AbbVie shall duly execute the quality agreement and safety data exchange agreement negotiated by the Parties for each Licensed Product pursuant to the POC Plan and for each Licensed Ophthalmology Product;", "": "" }, { "Text": "3.4.4 Inventory. Capsida shall provide AbbVie with a written summary of all of its inventory of all Licensed Capsids, Licensed Products, Licensed Ophthalmology Capsids and Licensed Ophthalmology Products that were produced in accordance with the applicable Plan, and Capsida shall, at AbbVie's election, promptly destroy such inventory or deliver such inventory to AbbVie DPP basis (as defined in Incoterms 2010) at a location designated by AbbVie. Capsida represents and warrants that, at the time of delivery, all supply of Licensed Products and Licensed Ophthalmology Products intended for clinical use (a) will have been Manufactured in accordance with applicable Law, including cGMP, (b) will not be adult", "": "" }, { "Text": "(d) review and approve the Additional Target Capsid Profile or Additional Target Product Profile (including any amendments thereto);", "": "" }, { "Text": "(e) make recommendations to AbbVie regarding which Capsids to advance to Reserved Capsids or Selected Capsids;", "": "" }, { "Text": "(f) make recommendations regarding the AbbVie Cargo, or other AbbVie Materials provided under the Research Program;", "": "" }, { "Text": "(g) prioritize the Capsids and select benchmark Capsids and tool cargo for Optimization and Screening Activities, approve any preliminary characterization study design under the Optimization and Screening Activities, and select the final cargo vector design for each Target for each Research Stage;", "": "" }, { "Text": "(h) coordinate the sequence and timing of Research Stages for each Target under the Research Plans;", "": "" }, { "Text": "(i) review and approve the ALS Development Plan and Budget and the ALS Commercialization Plan (including any amendments to the foregoing) and review and approve any amendments to the POC Plan; and", "": "" }, { "Text": "(j) perform such other functions as are set forth herein, if and as applicable, or as the Parties may mutually agree in writing.", "": "" }, { "Text": "7.1.2 The JGC for the Ophthalmology Program shall:", "": "" }, { "Text": "(a) review and approve any amendments or updates to the Ophthalmology Research Plan, that would result in an increase to: (i) the corresponding budget estimate by more than ten percent (10%) or (ii) the Screening Period by more than three (3) months and review any other amendments or updates to each Plan;", "": "" }, { "Text": "(b) oversee the Parties' activities under the Ophthalmology Research Plan and review the Parties' progress against the Ophthalmology Research Plan;", "": "" }, { "Text": "(c) make recommendations to AbbVie regarding which Capsids to advance to Reserved Ophthalmology Capsids or Selected Ophthalmology Capsids;", "": "" }, { "Text": "(d) make recommendations regarding the AbbVie Ophthalmology Cargo, or other AbbVie Materials provided under the Ophthalmology Research Program;", "": "" }, { "Text": "(e) prioritize the Capsids and select benchmark Capsids and tool cargo for Optimization and Screening Activities and other activities as specified in the Ophthalmology Research Plan, approve any preliminary characterization study design under the Optimization and Screening Activities, and select the final cargo vector design for each Route of Administration;", "": "" }, { "Text": "(f) coordinate the sequence and timing of Research for each Route of Administration and the activities with respect thereof;", "": "" }, { "Text": "(g) make recommendations to AbbVie regarding selection of the Ophthalmology Targets for the Ophthalmology Research Program (including, with respect to the Target List, the Selected Ophthalmology Targets, any substitution of the Selected Ophthalmology Targets and the Final Selected Ophthalmology Targets); and", "": "" }, { "Text": "(h) perform such other functions as are set forth herein, if and as applicable, or as the Parties may mutually agree in writing.", "": "" }, { "Text": "7.1.3 For clarity, once AbbVie exercises (a) a Capsid Program Option, the JGC for the Neurology Program shall no longer have jurisdiction over the Exploitation of the Licensed Capsid Program Capsids or Licensed Capsid Products by AbbVie and its Affiliates; or (b) an Ophthalmology Program Option, the JGC for the Ophthalmology Program shall no longer have jurisdiction over the Exploitation of the Licensed Ophthalmology Capsids or Licensed Ophthalmology Products by AbbVie and its Affiliates.", "": "" }, { "Text": "7.2 General Provisions Applicable to the JGCs.", "": "" }, { "Text": "7.2.1 Meetings and Minutes. Each JGC shall meet quarterly or as otherwise agreed to by the Parties, with the location of such meetings alternating between locations designated by Capsida and locations designated by AbbVie, with Capsida designating the place of the first meeting. The Alliance Managers of the Parties shall be responsible for calling meetings on no less than ten (10) days' notice unless exigent circumstances require shorter notice. Each Party shall make all proposals for agenda items at least ten (10) days in advance of the applicable meeting and shall provide all appropriate information with respect to such proposed items at least five (5) days in advance of the applicable meeting; provided that under exigent circumstances requiring input by a JGC, a Party may provide its agenda items to the other Party within a shorter period of time in advance of the meeting or may propose that there not be a specific agenda for a particular meeting, so long as the other Party consents to such later addition of such agenda items or the absence of a specific agenda for such meeting (which consent shall not be unreasonably withheld, conditioned or delayed). A Capsida member of a JGC shall prepare and circulate for review and approval of the Parties minutes of each meeting of such JGC within ten (10) days after the meeting. The Parties shall agree on the minutes of each meeting promptly, but in no event later than the next meeting of such JGC, and such approved minutes shall be signed by each Alliance Manager.", "": "" }, { "Text": "7.2.2 Procedural Rules. The JGCs shall have the right to adopt such standing rules as shall be necessary for its work, to the extent that such rules are not inconsistent with this Agreement. A quorum of a JGC shall exist whenever there is present at a meeting at least one (1) representative appointed by each Party. Representatives of the Parties on a JGC may attend a meeting either in person or by telephone, video conference or similar means in which each participant can hear what is said by and be heard by, the other participants. Representation of a JGC member by reasonably qualified proxy shall be allowed. Alliance Managers or other employees or consultants of a Party who are not representatives of the Parties on a JGC may attend meetings of such JGC; provided, however, that such attendees (a) shall not vote or otherwise participate in the decision-making process of such JGC and (b) are bound by obligations of confidentiality and non-disclosure at least as protective of the other Party as those set forth in Article 11.", "": "" }, { "Text": "7.2.3 Decision-Making. Subject to the following provisions of this Section 7.2.3, and except for any Legal Disputes (which shall be governed by Section 15.6), disputes under Section 9.21.2, and matters that require the mutual agreement of the Parties or with respect to which final decision-making authority is assigned under this Agreement to one Party, the JGC for a Program shall take action by consensus of the representatives present at a meeting at which a quorum exists, with each Party having a single vote irrespective of the number of representatives of such Party in attendance, or by a written resolution signed by at least one (1) representative appointed by each Party. Except for matters outside the jurisdiction and authority of the JGCs, as applicable (including as set forth in Section 7.2.4), if a JGC cannot, or does not, reach consensus on an issue within ten (10) Business Days after such issue is first presented to such JGC for consideration, then either Party shall have the right to refer such issue to the Senior Officers for attempted resolution by good faith negotiations during a period of ten (10) Business Days. Any final decision mutually agreed to by the Senior Officers shall be conclusive and binding on the Parties. If such issue has not been resolved by the Senior Officers in such ten (10) Business Day-period, then:", "": "" }, { "Text": "(a) Except as provided in Section 7.2.3(f), if the issue relates to the day-to-day performance of the activities under the Capsid Program Research Plan, the Collaboration Program Research Plan, or the Ophthalmology Research Plan (other than activities in respect of vector design and optimization including Expression Elements pursuant to Section 2.13.9) prior to AbbVie's exercise of any Initial Capsid Program Option, the Collaboration Program Option or Ophthalmology Program Option, as applicable, Capsida shall have final decision-making authority;", "": "" }, { "Text": "(b) if the issue relates to Capsid engineering, process development or Manufacturing scale-up activities to be performed by Capsida for the Research Program, Capsida shall have final decision-making authority under the Research Program (for clarity, Capsida shall not have final decision-making authority with respect to the supply agreement to be negotiated by the Parties pursuant to Section 5.2, the quality agreement to be negotiated by the Parties pursuant to Section 3.4.3 or with respect to the matters set forth in the final sentence of Section 5.2);", "": "" }, { "Text": "(c) if the issue relates to the conduct of Capsid engineering, process development or Manufacturing scale-up activities to be performed by Capsida for the Ophthalmology Research Program, Capsida shall have final decision-making authority under the Ophthalmology Research Program (for clarity, Capsida shall not have final decision-making authority with respect to the supply agreement to be negotiated by the Parties pursuant to Section 5.2, the quality agreement to be negotiated by the Parties pursuant to Section 3.4.3 or with respect to the matters set forth in the final sentence of Section 5.2);", "": "" }, { "Text": "(d) if the issue relates to the RP2 Plan for a Target, AbbVie shall have final decision-making authority to the extent the RP2 Plan is substantially similar to the then-current Capsid Program Research Plan for such Target with only such modifications as are necessary to address learnings from Research Stage One for such Target or to achieve the Additional Target Capsid Profile or Additional Target Product Profile for such Target, and any changes do not result in a budget that exceeds the budget for the Capsid Program Research Plan for such Target by more than ten percent (10%) or extend the timeline beyond the later of (i) for α-syn, the second (2nd) anniversary of the Option Exercise Date for the α-syn Program Option and the approval by the JGC for the Neurology Program of the Research Plan and Target Capsid Profile and Target Product Profile for Research Stage Two for α-syn and (ii) for Tau, the second (2nd) anniversary of the Option Exercise Date for the Tau Program Option and the approval by the JGC for the Neurology Program of the Research Plan and Target Capsid Profile and Target Profile for Research Stage Two for Tau;", "": "" }, { "Text": "(e) if the issue relates to (i) Licensed Capsids or Licensed Products from and after exercise of the α-syn Program Option, Tau Program Option, Additional Capsid Program Option or Collaboration Program Option, as applicable, including approval of the ALS Development Plan and Budget, ALS Commercialization Plan or any amendments thereto, or (ii) Licensed Ophthalmology Products or Licensed Ophthalmology Capsids from and after exercise of the IVT Option, SCS Option or IC Option, as applicable, in each case ((i) and (ii)), AbbVie shall have final decision-making authority (except with respect to amendments to the POC Plan, which shall be subject to Section 7.2.3(g), amendments to the ALS Development Plan and Budget that would require any additional activities by Capsida, which shall be subject to Section 7.2.3(g), or any Manufacturing conducted by or on behalf of Capsida which shall be subject to Article 5);", "": "" }, { "Text": "(f) if the issue relates to: (i) AbbVie Cargo (excluding the selection of the ALS Cargo for the Collaboration Research Program pursuant to Section 2.4), AbbVie Ophthalmology Cargo or other AbbVie Materials or the sequence and timing of Research Stages and of Research of Capsids, Targets or Routes of Administration (though, for clarity, not the duration of the seventy-five (75) month period referenced in clause (c)(ii) of the definition of \"Screening Period\") and the activities with respect thereof under any Plan, (ii) the selection or substitution of Capsids, including Reserved Capsids, Selected Capsids, Reserved Ophthalmology Capsids and Selected Ophthalmology Capsids (A) to progress through the Research Plans and Ophthalmology Research Plan, as applicable, (B) for inclusion in the Research Product Candidates, Research Products or Ophthalmology Research Products, as applicable, and (C) for the conduct of benchmarking, characterization studies and other Research activities, (iii) combining more than one (1), or eliminating any, Route of Administration in or from any particular activity under the Ophthalmology Research Program, (iv) the decision whether to progress to the Final Pooled Ophthalmology CIS Research Stage or Single Variant Characterization Studies Research Stage for any Route of Administration, (v) the decision whether to progress to any other Ophthalmology Research Stage solely to the extent based on (x) one (1) or more unanticipated safety or toxicity issues or (y) AbbVie's reasonable determination that the Results from the prior Ophthalmology Research Stage(s) are not likely to support the generation of Capsids that will meet the Ophthalmology Target Capsid Profile for the applicable Route of Administration, (vi) the selection of Ophthalmology Targets for the Ophthalmology Research Program pursuant to the process set forth in Section 2.13.11 (including, with respect to the Target List, the Selected Ophthalmology Targets including, any substitution of the Selected Ophthalmology Targets and the Final Selected Ophthalmology Targets), (vii) the selection of test or tool cargo or Expression Elements for use in the Research Program or in the Ophthalmology Research Program, as applicable (other than the selection of cargo used in the Initial Library Screening Research Stage, Variant Optimization Research Stage and Final Variant Optimization Research Stage), (viii) the engineering and improving of the Selected Ophthalmology Capsids pursuant to Section 2.13.9 and Expression Elements pursuant to Section 2.3.8 and Section 2.13.9 or any activities in respect of vector design and optimization related thereto, (ix) study design for preliminary and final characterization studies, (x) selection of a final Capsid-Expression Elements-cargo design or (xi) the contents of the Additional Target Capsid Profile or Additional Target Product Profile, AbbVie shall have final decision-making authority; and", "": "" }, { "Text": "(g) any other issue shall be deadlocked and neither Party shall have final decision-making authority with respect thereto.", "": "" }, { "Text": "7.2.4 Limitations on Authority. Notwithstanding anything in this Article 7 to the contrary, (a) each Party will retain the rights, powers and discretion granted to it under this Agreement and no such rights, powers or discretion will be delegated to or vested in the JGCs or any Working Group unless such delegation or vesting of rights is expressly provided for in this Agreement or the Parties expressly so agree in writing and (b) matters explicitly reserved to the consent, approval or other decision-making authority of one or both Parties, as expressly provided in this Agreement, are outside the jurisdiction and authority of the JGCs, including amendment, modification or waiver of compliance with this Agreement (which may only be amended or modified as provided in Section 15.9 or compliance with which may only be waived as provided in Section 15.12).", "": "" }, { "Text": "7.2.5 Discontinuation; Disbandment. Each JGC for a Program shall continue to exist until the first to occur of: (a) the Parties mutually agreeing to disband such JGC and (b) the expiration of the last Option Period without exercise by AbbVie of any Option with respect to such Program. Upon the occurrence of any of the foregoing, (x) the applicable JGC shall disband, have no further responsibilities or authority under this Agreement and will be considered dissolved by the Parties and (y) any requirement of Capsida to provide Know-How or other materials to such JGC shall be deemed a requirement to provide such Know-How or other materials to AbbVie and AbbVie shall have the right to solely decide, without consultation with Capsida, all matters that are subject to the review or approval by such JGC hereunder except as otherwise expressly provided herein. Notwithstanding the foregoing, upon the exercise of each Option (other than the Collaboration Program Option) by AbbVie, the applicable JGC shall have no further responsibilities or authority under this Agreement with respect to the Licensed Capsid Program Capsids (in the case of the JGC for the Neurology Program) or Licensed Ophthalmology Capsids (in the case of the JGC for the Ophthalmology Program) that are the subject of such Option or any Licensed Products containing such Licensed Capsids (in the case of the JGC for the Neurology Program) or Licensed Ophthalmology Products containing such Licensed Ophthalmology Capsids (in the case of the JGC for the Ophthalmology Program).", "": "" }, { "Text": "7.3 Working Groups. From time to time, a JGC may establish and delegate duties to other committees or directed teams (each, a \"Working Group\") on an \"as-needed\" basis to oversee particular projects or activities. During the conduct of the Research Program and the Ophthalmology Research Program, prior to the applicable Option Exercise Date, there will be a Manufacturing Working Group, Research Working Group and a Patent Working Group, in respect of the Research Program and separately in respect of the Ophthalmology Research Program. Each such Working Group shall be constituted and shall operate as the JGC determines; provided that each Working Group shall have qualified representation from each Party; and provided, further that any dispute between the representatives of each Party on a Working Group shall be referred to the JGC for the applicable Program for resolution in accordance with Section 7.2.3 and the other terms and conditions of this Agreement. Working Groups may be established by a JGC on an ad hoc basis for purposes of a specific project, for the term of the applicable JGC or on such other basis as the JGC may determine. Each Working Group and its activities shall be subject to the oversight, review and approval of, and shall report to, the JGC for the applicable Program. In no event shall the authority of the Working Group exceed that specified for the JGCs in this Article 7.", "": "" }, { "Text": "7.3.1 Manufacturing Working Group. Pursuant to the Original Agreement, the Parties have, as of the Effective Date, established a Manufacturing Working Group in respect of Manufacturing for the Research Program. Within thirty (30) days following the Effective Date the JGC shall establish a Manufacturing Working Group in respect of the Ophthalmology Research Program. The Manufacturing Working Groups' responsibilities may, as applicable for the applicable Manufacturing Working Group, include: (a) establishing a cGMP Manufacturing readiness plan and monitoring Capsida's progress with respect thereto, (b) determining the appropriate time for the negotiation and entry into the supply agreement to be negotiated by the Parties pursuant to Section 5.2 and the quality agreement to be negotiated by the Parties pursuant to Section 3.4.3 and (c) providing the JGC and Parties with guidance with respect to matters relating to the Manufacturing of Expression Elements, and, in the case of the Manufacturing Working Group for the Research Program, matters relating to the Manufacturing of Research Product Candidates, Research Products, Licensed Capsids and Licensed Products by Capsida, and, in the case of the Manufacturing Working Group for the Ophthalmology Research Program, matters relating to the Manufacturing of Ophthalmology Research Product Candidates, Ophthalmology Research Products, Licensed Ophthalmology Capsids and Licensed Ophthalmology Products by Capsida, and in each case the transfers of Manufacturing Processes to AbbVie or its designee pursuant to Section 5.3.", "": "" }, { "Text": "7.3.2 Research Working Group. Pursuant to the Original Agreement, the Parties have, as of the Effective Date established a Research Working Group in respect of the Research Program. Within thirty (30) days following the Effective Date the JGC shall establish a Research Working Group in respect of the Ophthalmology Research Program. The Research Working Groups' responsibilities may, as applicable for the particular Research Working Group and as may be further set forth in the Research Plan or the Ophthalmology Research Plan, as applicable, include: (a) selecting the top-performing variants for a second round of screening during the Initial Library Screening or the Initial Library Screening Research Stage, as applicable, (b) (i) in respect of the Research Program, selecting five (5) of the top-performing variants as Reserved Capsids after the Initial Library Screening, and (ii) in respect of the Ophthalmology Research Program, selecting the Reserved Ophthalmology Capsids together with other top-performing Capsids after the Initial Library Screening Research Stage to progress to the next Ophthalmology Research Stage, (c) in respect of the Ophthalmology Research Program, selecting the Reserved Ophthalmology Capsids together with other top-performing Capsids after the First Pooled Candidate Identification Studies Research Stage to progress to the next Ophthalmology Research Stage(s), (d) (i) in respect of the Research Program, selecting five (5) of the top-performing variants as Reserved Capsids after Variant Optimization, and (ii) in respect of the Ophthalmology Research Program, selecting the Reserved Ophthalmology Capsids together with other top-performing Capsids after the Variant Optimization Research Stage to progress to the next Ophthalmology Research Stage(s), (e) (i) in respect of the Research Program, selecting five (5) of the top-performing variants as Reserved Capsids after Pooled Screening, and (ii) in respect of the Ophthalmology Research Program, selecting the Reserved Ophthalmology Capsids together with other top-performing Capsids after the Secondary Pooled Ophthalmology CIS Research Stage to progress to the next Ophthalmology Research Stage, (f) in respect of the Research Program, determining the top-performing variants and benchmark capsids to be included in Variant Optimization and Pooled Screening, (g) in respect of the Ophthalmology Research Program, selecting the Reserved Ophthalmology Capsids together with other top-performing Capsids after the Final Variant Optimization Research Stage to progress to the next Ophthalmology Research Stage (h) determining the study design and timing for Preliminary and Final Individual Capsid Characterization or Single Variant Characterization Studies, as applicable, (i) making the selection of Capsids, Expression Elements and cargo for vector design and optimization, (j) making scientific decisions required to reasonably progress the programs based on technical information and analysis of data, (k) in respect of the Ophthalmology Research Program, making recommendations to the JGC for the Ophthalmology Program regarding whether to progress to the next applicable Ophthalmology Research Stage, (l) reviewing and approving amendments to the Research Plan or Ophthalmology Research Program, as applicable, that result in an increase to the corresponding budget estimate by ten percent (10%) or less and increase the associated Screening Period by three (3) months or less, and (m) maintaining frequent and ad hoc communication and scientific dialogue between the Parties. Capsida shall share with AbbVie, through the Research Working Group, all scientifically relevant information in Capsida's possession or control generated through Capsida's Exploitation of deselected or unselected Capsids from the Ophthalmology Research Program, to the extent reasonably necessary or useful to inform AbbVie's selection of Selected Ophthalmology Capsids, Reserved Ophthalmology Capsids or other Capsids for use in the Ophthalmology Research Program for each Route of Administration.", "": "" }, { "Text": "7.4 Alliance Managers. Each Party shall appoint a person(s) who shall oversee contact between the Parties for all matters between meetings of each JGC, shall be the primary contacts between the Parties after disbandment of each JGC, and shall have such other responsibilities as the Parties may agree in writing after the Effective Date, which person(s) may be replaced at any time by notice in writing to the other Party. The Alliance Managers shall work together to manage and facilitate the communication between the Parties under this Agreement, including the resolution (in accordance with the terms of this Agreement) of issues between the Parties that arise in connection with this Agreement. The Alliance Managers shall not have final decision-making authority with respect to any matter under this Agreement.", "": "" }, { "Text": "ARTICLE 8 GRANT OF RIGHTS; EXCLUSIVITY", "": "" }, { "Text": "8.1 Grants to AbbVie. Subject to Section 8.3 and Section 8.4, without limiting AbbVie's rights or Capsida's obligations under Section 8.8.1, Section 8.8.2 and Section 8.8.3, Capsida (on behalf of itself and its Affiliates) hereby grants to AbbVie and its Affiliates:", "": "" }, { "Text": "8.1.1 Until the completion of all activities under the applicable Plan, a non-exclusive, royalty-free license (or sublicense), with the right to grant sublicenses in accordance with Section 8.3, under the Licensed IP solely to perform AbbVie's activities under the applicable Plan as set forth in, and subject to, the applicable Plan;", "": "" }, { "Text": "8.1.2 Until the earlier of the expiration of the last Capsid Selection Period for a Target for a Research Stage and the date on which AbbVie has selected three (3) Selected Capsids for such Target, a non-exclusive, royalty-free license (or sublicense), with the right to grant sublicenses in accordance with Section 8.3, under the Licensed IP solely to perform additional Development activities with respect to the Reserved Capsids in any General Capsid Library or Target-specific Capsid Library to enable AbbVie to make an informed decision regarding whether to select such Reserved Capsids to be Selected Capsids or to exercise the α-syn Program Option, the Tau Program Option or the Collaboration Program Option;", "": "" }, { "Text": "8.1.3 Until the earlier of the expiration of the last Capsid Ophthalmology Selection Period for the last Route of Administration and the date on which AbbVie has selected three (3) Selected Ophthalmology Capsids for each Route of Administration, a non-exclusive, royalty-free license (or sublicense), with the right to grant sublicenses in accordance with Section 8.3, under the Licensed IP solely to perform additional Research or Development activities with respect to the Reserved Ophthalmology Capsids in any General Capsid Library or Route of Administration-specific Capsid library to enable AbbVie to make an informed decision regarding whether to select such Reserved Ophthalmology Capsids to be Selected Ophthalmology Capsids or to exercise the IC Option, the IVT Option, or the SCS Option;", "": "" }, { "Text": "8.1.4 Upon the exercise of any Capsid Program Option, the Collaboration Program Option or any Ophthalmology Program Option by AbbVie, an exclusive (even as to Capsida and its Affiliates), royalty-bearing (in accordance with Section 9.5 and, in the case of ALS Products, subject to Section 9.13) license (or sublicense), with the right to grant sublicenses in accordance with Section 8.3, under the Licensed IP to Exploit (a) in the case of a Capsid Program Option, Licensed Capsids that are the subject of the applicable Option for use with cargo directed to the Licensed Target(s) and corresponding Licensed Products in the Field in the Territory; (b) in the case of the Collaboration Program Option, subject to Capsida's rights under Section 4.2 and Section 6.3 with respect to ALS Products, Licensed Collaboration Program Capsids for use with cargo directed to the Licensed Target(s) and Licensed Products that contain Licensed Collaboration Program Capsids in the Field in the Territory; and (c) in the case of an Ophthalmology Program Option, Licensed Ophthalmology Capsids that are the subject of the applicable Option for use with cargo directed to Final Selected Ophthalmology Targets, and any Licensed Ophthalmology Products that contain such Licensed Ophthalmology Capsids in the Field in the Territory;", "": "" }, { "Text": "8.1.5 upon the exercise of any Initial Capsid Program Option, the Collaboration Program Option or any Ophthalmology Program Option by AbbVie, an exclusive (even as to Capsida and its Affiliates except with respect to Capsida's and its Affiliates' own internal programs) license (or sublicense) and right of reference, with the right to grant sublicenses and further rights of reference in accordance with Section 8.3, (a) in the case of a Capsid Program Option or Collaboration Program Option, under the Regulatory Approvals related to the Licensed Capsids held by Capsida and its Affiliates, to Exploit Licensed Capsids for use with Licensed Target(s) and Licensed Products in the Field in the Territory; and (b) in the case of an Ophthalmology Program Option, under the Regulatory Approvals related to the Licensed Ophthalmology Capsids held by Capsida and its Affiliates, to Exploit Licensed Ophthalmology Capsids for use with Final Selected Ophthalmology Targets and Licensed Ophthalmology Products in the Field in the Territory; and", "": "" }, { "Text": "8.1.6 upon the exercise of an Initial Capsid Program Option, the Collaboration Program Option or an Ophthalmology Program Option by AbbVie, a non-exclusive license, with the right to grant sublicenses in accordance with Section 8.3, to use Capsida's Corporate Names solely as required to Exploit Licensed Capsids and Licensed Products or Licensed Ophthalmology Capsids and Licensed Ophthalmology Products, as applicable, in the Field in the Territory, subject to compliance with Capsida's standard trademark guidelines (as provided by Capsida to AbbVie one hundred eighty (180) days prior to any such use) and for no other purpose.", "": "" }, { "Text": "For clarity, the licenses granted pursuant to Sections 8.1.4 to 8.1.6 shall expand to include the Licensed Capsids or Licensed Ophthalmology Capsids with respect to each Option exercised by AbbVie and shall contract to exclude any Capsid that ceases to be a Licensed Capsid or Licensed Ophthalmology Capsid, as applicable.", "": "" }, { "Text": "8.2 Grants to Capsida. Subject to Section 8.3 and Section 8.8, without limiting Capsida's rights or AbbVie's obligations under Section 8.8.4, AbbVie hereby grants to Capsida and the other provisions of this Agreement:", "": "" }, { "Text": "8.2.1 during the performance of its activities under the Research Program, a non-exclusive, royalty-free license and right of reference, without the right to grant sublicenses or further rights of reference (except to a permitted subcontractor), under the AbbVie Background Know-How for Research Program and the AbbVie Background Patents for Research Program and the Cargo IP solely for purposes of performing its obligations under the Research Program as set forth in, and subject to, the applicable Research Plan;", "": "" }, { "Text": "8.2.2 during the performance of its activities under the Ophthalmology Research Program, a non-exclusive, royalty-free license and right of reference, without the right to grant sublicenses or further rights of reference (except to a permitted subcontractor), under the AbbVie Background Know-How for Ophthalmology Research Program and the AbbVie Background Patents for Ophthalmology Research Program and the Cargo IP for the Ophthalmology Research Program solely for purposes of performing its obligations under the Ophthalmology Research Program as set forth in, and subject to, the Ophthalmology Research Plan;", "": "" }, { "Text": "8.2.3 from and after AbbVie's exercise of the Collaboration Program Option, a non-exclusive, royalty-free license, without the right to grant sublicenses or further rights of reference (except to a permitted subcontractor) under (a) AbbVie's interest in the Program IP and Joint IP, (b) AbbVie Background Know-How for ALS and AbbVie Background Patents for ALS and (c) any Cargo IP that specifically covers or claims the ALS Cargo and that is necessary, in each case ((a)-(c)), to Develop, Manufacture and Commercialize the ALS Product, solely for ALS and solely in accordance with this Agreement, the Co-Promotion Agreement, the POC Plan, the ALS Development Plan and Budget and the ALS Commercialization Plan; and", "": "" }, { "Text": "8.2.4 from and after the ALS Reversion Triggering Event, and Capsida's exercise of its rights under Section 4.4 to assume, at its sole cost and expense, control of the Development, Manufacturing and Commercialization of the ALS Product in accordance with Section 4.4, an exclusive (except as provided in Section 8.6.1), royalty-bearing license, with the right to grant sublicenses through multiple tiers of Sublicensees, under the Reversion IP, solely to Develop, Manufacture, Commercialize and otherwise Exploit the ALS Reversion Product for ALS, in accordance with Section 4.4.", "": "" }, { "Text": "8.3 Sublicenses. Each Party shall have the right to grant sublicenses (or further rights of reference), through multiple tiers of Sublicensees to the extent specified in Section 8.1 or Section 8.2, as applicable, under the licenses and rights of reference granted in Section 8.1 or Section 8.2, as applicable, to its Affiliates and other Third Parties; provided that any such sublicenses shall be consistent with the terms and conditions of this Agreement and each Party shall remain responsible for the performance of all of its Sublicensees to the same extent that such performance is to fulfill such Party's obligations under this Agreement, as if such obligations were conducted by such Party.", "": "" }, { "Text": "8.4 In-License Agreements.", "": "" }, { "Text": "8.4.1 Existing In-License Agreements.", "": "" }, { "Text": "(a) Without limiting the representations, warranties and covenants set forth in Article 12, AbbVie acknowledges and agrees that the sublicenses granted by Capsida to AbbVie in this Agreement are subject to the terms of the Existing In-License Agreements, the scope of the licenses granted to Capsida or the applicable Affiliate thereunder and the rights granted to or retained by the Third Party counterparties thereof and any other Third Party with rights thereunder (including governmental authorities, as applicable) (each, an \"Inbound Licensor\").", "": "" }, { "Text": "(b) The Parties shall cooperate with each other in good faith to support each other in complying with Capsida's obligations under each Existing In-License Agreement. Without limitation to the foregoing, (i) the Parties shall, from time to time, upon the reasonable request of either Party, discuss the terms of an Existing In-License Agreement and agree upon, to the extent reasonably possible, a consistent interpretation of the terms of such Existing In-License Agreement in order to, as fully as possible, allow Capsida to comply with the terms of such Existing In-License Agreement and AbbVie to receive its rights and benefits under this Agreement; (ii) to the extent there is a conflict between any terms of this Agreement and any terms of any Existing In-License Agreement, the terms of such Existing In-License Agreement shall control with respect to the relevant Know-How, Patents or other rights granted to AbbVie hereunder; and (iii) although Capsida is subject to making certain payments under the In-License Agreements as set forth in Section 8.4.3, AbbVie and its Affiliates and Sublicensees shall comply with any applicable reporting and other requirements under the Existing In-License Agreements, and the provisions regarding currency conversion, international payments and late payments, and any other relevant definitions and provisions, of the relevant In-License Agreements shall apply to the calculation of the payments due under the relevant Existing In-License Agreements; provided that when and as reasonably requested by AbbVie, Capsida shall use reasonable efforts to obtain waivers or amendments to, or exercise its rights under, the Existing In-License Agreements so as to harmonize AbbVie's obligations under this Section 8.4.1(b) with the corresponding provisions of this Agreement. Notwithstanding any of the foregoing, to the extent any rights or technology licensed to Capsida under the CalTech License Agreement (collectively, \"CalTech IP\") are covered by the license grants to AbbVie under this Agreement, nothing in this Agreement shall grant to AbbVie any rights with respect to such CalTech IP that are greater than those granted to Capsida pursuant to the CalTech License Agreement.", "": "" }, { "Text": "8.4.2 Future In-License Agreements.", "": "" }, { "Text": "(a) Subject to Section 10.6, prior to Capsida or any of its Affiliates entering into a license or other agreement with a Third Party pursuant to which Capsida or any of its Affiliates would acquire, license or obtain any right or interest in any invention, material or Know-How (or any Third Party Rights) that may be necessary or reasonably useful (x) to conduct the Research Program, the POC Plan or the Ophthalmology Research Program or to achieve the objectives thereof or (y) to Exploit any Licensed Capsid, Licensed Product, Licensed Ophthalmology Capsid or Licensed Ophthalmology Product, as applicable, (such activities (x) and (y), the \"Program Activities\", any such invention, material or Know-How, a \"Subject Technology\" and such license or other agreement, a \"Subject Technology Agreement\"), Capsida shall use reasonable and good faith efforts to determine whether or not such Subject Technology would reasonably be expected to be necessary for the Program Activities, which efforts shall include (A) consulting with the Vice President of Research and the Vice President of Technology of Capsida (or the executive officers of Capsida with equivalent responsibilities) and the other Capsida personnel responsible for leading the Research Program or the Ophthalmology Research Program, as applicable, and (B) conducting such investigations and assessments, including where possible any relevant tests and studies, as are reasonably necessary to make such a determination. Any Subject Technology that specifically relates to the Capsida Platform and is incorporated into, or is necessary or reasonably useful to Exploit, a Licensed Capsid, Licensed Product, Licensed Ophthalmology Capsid or Licensed Ophthalmology Product, as applicable, shall be deemed to be necessary for Program Activities unless the Parties agree otherwise in writing. For clarity, this Section 8.4.2 shall not apply to any license or other agreement with a Third Party that solely relates to AbbVie Cargo or AbbVie Ophthalmology Cargo, which shall be subject to Section 8.5.", "": "" }, { "Text": "(i) With respect to any Subject Technology that is necessary for the Program Activities, Capsida may enter into a Subject Technology Agreement that is consistent with the terms and conditions of this Agreement in all material respects and does not in any way limit AbbVie's rights and interests or increase its obligations hereunder, except to the extent that such agreement and any such inconsistency, limitation or obligation is agreed to in writing by AbbVie prior to execution.", "": "" }, { "Text": "(b) With respect to any Subject Technology that is not necessary for the Program Activities, (A) Capsida may enter into such Subject Technology Agreement on such terms and conditions as it determines, provided that the terms and conditions applicable to the Program Activities are no less favorable than the terms and conditions applicable to any other targets, programs or activities of Capsida and (B) unless such Subject Technology Agreement is consistent with the terms and conditions of this Agreement in all material respects and does not in any way limit AbbVie's rights and interests or increase its obligations hereunder, Capsida shall not use or incorporate any such Subject Technology in the Research Program or the Ophthalmology Research Program, or in any Program Capsid, Ophthalmology Program Capsid, Reserved Capsid, Reserved Ophthalmology Capsid, Research Product, Ophthalmology Research Product, Selected Capsid, Selected Ophthalmology Capsid, Licensed Capsid, Licensed Ophthalmology Capsid, Licensed Product or Licensed Ophthalmology Product, unless and until such agreement and any such inconsistency, limitation or obligation is agreed to in writing by AbbVie. If, after Capsida or any of its Affiliates enters into a Subject Technology Agreement with respect to any Subject Technology pursuant to Section 8.4.2(b), Capsida or AbbVie determines that such Subject Technology is necessary for the Program Activities, then Capsida shall, at its sole cost and expense, use Commercially Reasonable Efforts to amend such Subject Technology Agreement to be consistent with the terms and conditions of this Agreement in all material respects and to not in any way limit AbbVie's rights and interests or increase its obligations hereunder, except to the extent that such agreement and any such inconsistency, limitation or obligation is agreed to in writing by AbbVie. Capsida shall consult and coordinate with AbbVie with respect to Capsida's efforts to amend such Subject Technology Agreement under this Section 8.4.2(b) and shall consider in good faith AbbVie's recommendations with respect thereto. Capsida shall not use or incorporate any such Subject Technology in the Research Program or the Ophthalmology Research Program or in any Program Capsid, Ophthalmology Program Capsids, Reserved Capsid, Reserved Ophthalmology Capsids, Research Product, Ophthalmology Research Product, Selected Capsid, Selected Ophthalmology Capsid, Licensed Capsid, Licensed Ophthalmology Capsid, Licensed Product or Licensed Ophthalmology Product, until such agreement is amended in accordance with the immediately preceding sentence or any such inconsistency, limitation or obligation is agreed to in writing by AbbVie, not to be unreasonably withheld, conditioned or delayed.", "": "" }, { "Text": "8.4.3 Payments under In-License Agreements. Capsida shall be solely responsible for any license fees, milestones, royalties or other payments owed to Third Parties under or in connection with (a) the Existing In-License Agreement (whether or not any such Existing In-License Agreement is disclosed to AbbVie prior to the Effective Date) and (b) the Future Capsida In-License Agreements to the extent relating to (i) the Capsida Platform as it exists as of the Effective Date, (ii) any Subject Technology that is necessary to conduct the Program Activities or (iii) any Subject Technology that is not necessary to conduct the Program Activities where the Subject Technology Agreement (together with any financial or other obligations of AbbVie) was not disclosed to, and expressly approved by, AbbVie pursuant to Section 8.4.2(b). For clarity, if AbbVie expressly agrees to the use of any Subject Technology in connection with the Program Activities, AbbVie shall be responsible for royalties and milestones that become due under such Subject Technology Agreement specifically attributable to the Development, Manufacturing and Commercialization (and commencing as of the Option Exercise Date, also the Research) of a Licensed Product or a Licensed Ophthalmology Product, in each case, by AbbVie, its Sublicensees and its and their Affiliates, subject to its right to offset any such amounts pursuant to Section 9.6.4 and Section 9.6.5 and AbbVie agrees to comply with any obligations under such Subject Technology Agreement that applies to AbbVie, in each case, solely to the extent disclosed to, and expressly agreed by, AbbVie pursuant to Section 8.4.2(b).", "": "" }, { "Text": "8.4.4 Amendments; Breaches; Terminations. After the Effective Date, (a) Capsida shall not enter into any subsequent agreement or understanding with any Third Party to an In-License Agreement that modifies, amends or terminates any such In-License Agreement, or waives any right or obligation thereunder, in any way that would adversely affect in any material respect AbbVie's rights or interests under this Agreement, including by increasing any of AbbVie's obligations, without AbbVie's prior written consent and (b) Capsida shall not, and shall cause its Affiliates not to, commit any acts or permit the occurrence of any omissions that would cause breach or termination of any In-License Agreement. Without limiting the preceding sentence, Capsida shall provide to AbbVie for review, comment and, if applicable, approval a copy of all proposed modifications to, amendments of or waivers with respect to the In-License Agreements, regardless of whether AbbVie's approval is required with respect thereto, reasonably in advance of the execution thereof for AbbVie's review and comment and shall consider in good faith any comments provided by AbbVie.", "": "" }, { "Text": "8.5 Section intentionally left blank.", "": "" }, { "Text": "8.6 Retention of Rights.", "": "" }, { "Text": "8.6.1 Notwithstanding the exclusive licenses granted to Capsida pursuant to Section 8.2.4, AbbVie retains the right under the Reversion IP to Exploit products, including gene therapy products, directed to TDP-43 and the ALS Cargo (other than the ALS Reversion Product).", "": "" }, { "Text": "8.6.2 Except as otherwise expressly provided in this Agreement, under no circumstances shall a Party, as a result of this Agreement, obtain any ownership interest, license right or other right in any Know-How, Patent or other intellectual property rights of the other Party or any of its Affiliates, including items owned, controlled, developed or acquired by the other Party or any of its Affiliates, or provided by the other Party to the first Party at any time pursuant to this Agreement.", "": "" }, { "Text": "8.7 Confirmatory Patent License. Capsida shall if requested to do so by AbbVie immediately enter into confirmatory license agreements in such form as may be reasonably requested by AbbVie for purposes of recording the licenses granted under this Agreement with such patent offices in the Territory as AbbVie considers appropriate. Until the execution of any such confirmatory licenses, so far as may be legally possible, Capsida and AbbVie shall have the same rights in respect of the Patents within the Licensed IP and Joint Patents and be under the same obligations to each other in all respects as if the said confirmatory licenses had been executed.", "": "" }, { "Text": "8.8 Exclusivity.", "": "" }, { "Text": "8.8.1 Research Program and Licensed Capsid Products and Ophthalmology Research Program and Licensed Ophthalmology Products.", "": "" }, { "Text": "(a) Without limiting Capsida's obligations with respect to General Capsid Libraries, Target-specific Capsid Libraries and Reserved Capsids pursuant to Section 2.3, during the period commencing on the Effective Date and ending on the expiration of the Capsid Program Option Period, Capsida shall not, and, subject to Section 15.4, shall cause its Affiliates not to, directly or indirectly (except with respect to activities conducted under and in accordance with the Capsid Program Research Plan and as agreed with respect to Manufacturing), Exploit, or license, authorize, appoint, or otherwise assist or enable any Third Party to directly or indirectly Exploit, in each case anywhere in the Territory, (i) any Capsid for use with α-syn or Tau or (ii) any product directed to α-syn or Tau.", "": "" }, { "Text": "(b) If AbbVie exercises any Capsid Program Option, then during the period commencing on the applicable Option Exercise Date and ending on the expiration of the last Royalty Term for a Licensed Capsid Product for the applicable Target, Capsida shall not, and shall cause its Affiliates not to, directly or indirectly (except with respect to activities conducted under and in accordance with the Capsid Program Research Plan and as agreed with respect to Manufacturing), Exploit, or license, authorize, appoint, or otherwise assist or enable any Third Party to directly or indirectly Exploit, in each case anywhere in the Territory, any (x) Licensed Capsid Program Capsid for use with, or (y) product directed to, α-syn or Tau, as applicable.", "": "" }, { "Text": "(c) If AbbVie exercises any Ophthalmology Program Option, then during the period commencing on the applicable Option Exercise Date and ending on the expiration of the last Royalty Term for the last Licensed Ophthalmology Product directed to a Final Selected Ophthalmology Target, Capsida shall not, and shall cause its Affiliates not to, directly or indirectly (except with respect to activities conducted under and in accordance with the Ophthalmology Research Plan and as agreed with respect to Manufacturing), Exploit, or license, authorize, appoint or otherwise assist or enable any Third Party to directly or indirectly Exploit, in each case anywhere in the Territory, any (x) Licensed Ophthalmology Product for use with, or (y) product directed to, such Final Selected Ophthalmology Target, in each case, subject to Section 2.14.2 only and to the extent a Field restriction is applicable to such Final Selected Ophthalmology Target pursuant to Section 2.14.2 (in which case this clause (c) shall apply only to activities with respect to such Final Selected Ophthalmology Target in the AbbVie Reserved Field).", "": "" }, { "Text": "(d) Without limiting Capsida's obligations with respect to General Ophthalmology Capsid Libraries and Reserved Ophthalmology Capsids pursuant to Section 2.13, Capsida shall not, and, subject to Section 15.4, shall cause its Affiliates not to, directly or indirectly (except with respect to activities conducted under and in accordance with the Ophthalmology Research Plan and as agreed with respect to Manufacturing), Exploit, or license, authorize, appoint, or otherwise assist or enable any Third Party to directly or indirectly Exploit, in each case anywhere in the Territory:", "": "" }, { "Text": "(i) during the period commencing on the Effective Date and ending on the earlier of the date that is (a) twenty-four (24) months from the end of the first Ophthalmology Program Option Period, which period may be extended on a month-by-month basis until delivery of the first Ophthalmology Program Option Exercise Notice and (b) seventy-eight (78) months after the Effective Date, (x) any Capsid for use for the AbbVie Indications or (y) any product for the AbbVie Indications.", "": "" }, { "Text": "(ii) all Ophthalmology Targets on the Target List (except for any Ophthalmology Target removed from the Target List by AbbVie; provided that AbbVie may not re-select any Ophthalmology Target with respect to which Capsida has, consistent with its other exclusivity obligations, entered into a third-party agreement or otherwise pursued such target as described in Section 2.13.11) until the date that is (a) the later of (x) the end of the twenty-fourth (24th) month after selection of the Final Selected Ophthalmology Target for the first Route of Administration for which AbbVie exercises the applicable Ophthalmology Program Option and (y) the end of the twelve (12) month period following delivery of a Final Ophthalmology Data Package for the last Route of Administration, or, if earlier, (b) seventy-eight (78) months after the Effective Date, after which time such exclusivity restrictions shall be limited to the Final Selected Ophthalmology Targets; and", "": "" }, { "Text": "(iii) all Reserved Ophthalmology Capsids until such time as AbbVie may no longer designate any Reserved Ophthalmology Capsid as a Selected Ophthalmology Capsid for a Route of Administration under the terms of this Agreement, after which time the exclusivity restriction shall be limited to Selected Ophthalmology Capsids, but only for Final Selected Ophthalmology Targets. For clarity: (A) if (1) AbbVie deselects a Reserved Ophthalmology Capsid for a Route of Administration and then later reselects such Capsid as a Reserved Ophthalmology Capsid for such Route of Administration or (2) AbbVie selects a Capsid as a Reserved Ophthalmology Capsid after all Ophthalmology Selection Periods for such Capsid have expired and, in each case ((1) and (2)), such Capsid is not otherwise a Reserved Ophthalmology Capsid and is not a Selected Ophthalmology Capsid, then this Section 8.8.1(d)(iii) shall not apply to such Reserved Ophthalmology Capsid, but Article 2A and the remainder of this Article 8 shall continue to apply to such Capsid (including AbbVie's rights to Exploit such Capsid in any Ophthalmology Research Stage and to select such Capsid as a Selected Ophthalmology Capsid for any Route of Administration), and (B) if a Selected Ophthalmology Capsid does not become a Licensed Ophthalmology Capsid pursuant to Section 3.3, Capsida shall retain the right to Exploit such Capsid consistent with Section 8.8.1(d)(i) and Section 8.8.1(d)(ii).", "": "" }, { "Text": "For clarity, AbbVie shall retain the right to use all AbbVie Ophthalmology Cargo, including AbbVie Ophthalmology Cargo used in Licensed Ophthalmology Products, for any and all purposes, including in connection with other gene therapy platforms and delivery approaches.", "": "" }, { "Text": "8.8.2 Collaboration Research Program and ALS Products.", "": "" }, { "Text": "(a) Without limiting Capsida's obligations with respect to General Capsid Libraries, Target-specific Capsid libraries and Reserved Capsids pursuant to Section 2.3, during the period commencing on the Effective Date and ending on the expiration of the Collaboration Program Option Period, Capsida shall not, and shall cause its Affiliates not to, directly or indirectly (except with respect to activities conducted under and in accordance with the Collaboration Program Research Plan), Exploit, or license, authorize, appoint, or otherwise assist or enable any Third Party to directly or indirectly Exploit, in each case anywhere in the Territory, any (i) Capsid for use with TDP-43, or (ii) product directed to, TDP-43.", "": "" }, { "Text": "(b) If AbbVie exercises the Collaboration Program Option, then during the period commencing on such option exercise and ending on the expiration of the last Profit Share Term or Royalty Term for an ALS Product, Capsida shall not, and shall cause its Affiliates not to, directly or indirectly (except with respect to activities conducted under and in accordance with the Collaboration Program Research Plan, the POC Plan or any other Plan, as applicable), Exploit, or license, authorize, appoint, or otherwise assist or enable any Third Party to directly or indirectly Exploit, in each case anywhere in the Territory, any (i) Licensed Capsid for use with TDP-43 or (ii) product directed to, TDP-43.", "": "" }, { "Text": "8.8.3 Licensed Capsids. Without limiting Capsida's obligations with respect to General Capsid Libraries, Target-specific Capsid Libraries and Reserved Capsids pursuant to Section 2.3, Section 8.8.1 or Section 8.8.2, Capsida shall not, and shall cause its Affiliates not to, directly or indirectly (except with respect to activities conducted under and in accordance with a Plan), Exploit any Reserved Capsid for so long as it is a Reserved Capsid, Selected Capsid, Research Product, Licensed Capsid or Licensed Product for (a) with respect to Tau, any indication for the treatment, prevention, mitigation, cure of, or for the relief of symptoms associated with, Alzheimer's disease or (b) with respect to α-syn, any indication for the treatment, prevention, mitigation, cure of, or for the relief of symptoms associated with, Parkinson's disease, in each case ((a) and (b)) until the earlier of (i) the expiration without exercise by AbbVie of the Initial Capsid Option Period for Tau and α-syn, respectively, and (ii) the third (3rd) anniversary of the Option Exercise Date for Tau and α-syn, respectively.", "": "" }, { "Text": "8.8.4 AbbVie Cargo. Except as expressly set forth in this Section 8.8.4, AbbVie shall retain the right to use all AbbVie Cargo outside of this Agreement for any and all purposes, including in connection with other gene therapy platforms and delivery approaches. Unless and until AbbVie fails to exercise the Collaboration Program Option during the Collaboration Program Option Period or the Collaboration Research Program is terminated, AbbVie shall not, and shall cause its Affiliates not to, directly or indirectly, Develop or Commercialize or license, authorize, appoint, or otherwise assist or enable any Third Party to directly or indirectly Develop or Commercialize AbbVie Cargo directed to TDP-43 in combination with any another AAV gene therapy platform; provided, however, that AbbVie shall have the right to conduct internal Research activities with respect to TDP-43 with gene therapy platforms and delivery approaches.", "": "" }, { "Text": "8.8.5 Acknowledgement. The Parties acknowledge and agree that (a) this Section 8.8 has been negotiated by the Parties, (b) the geographical and time limitations on activities set forth in this Section 8.8 are reasonable, valid and necessary in light of the Parties' circumstances and necessary for the adequate protection of the activities under this Agreement and (c) AbbVie would not have entered into this Agreement without the protection afforded it by this Section 8.8. If, notwithstanding the foregoing, a court of competent jurisdiction determines that the restrictions set forth in this Section 8.8 are too broad or otherwise unreasonable under Applicable Law, including with respect to duration, geographic scope or space, the court is hereby requested and authorized by the Parties to revise this Section 8.8 to include the maximum restrictions allowable under Applicable Law.", "": "" }, { "Text": "ARTICLE 9 PAYMENTS AND RECORDS", "": "" }, { "Text": "9.1 Upfront Payment and First Final Ophthalmology Data Package Payment.", "": "" }, { "Text": "9.1.1 Original Neurology Rights. The Parties acknowledge and agree that the payment that was required by Section 9.1 of the Original Agreement was paid in full and no further upfront payment is due hereunder with respect to the Original Neurology Rights.", "": "" }, { "Text": "9.1.2 Ophthalmology Rights. In partial consideration of the Ophthalmology Rights granted by Capsida to AbbVie hereunder, and subject to the terms and conditions of this Agreement, no later than ten (10) days following the Effective Date, AbbVie shall pay Capsida a one-time upfront payment equal to Sixty Million Dollars ($60,000,000).", "": "" }, { "Text": "9.1.3 Additional Ophthalmology Research Program Payment. In partial consideration of the rights granted by Capsida to AbbVie hereunder, and subject to the terms and conditions of this Agreement, no later than ten (10) days after the delivery by Capsida to AbbVie of the first Final Ophthalmology Data Package, AbbVie shall pay Capsida a one-time payment of Twenty-Five Million Dollars (US$25,000,000).", "": "" }, { "Text": "9.2 Equity Investment.", "": "" }, { "Text": "The Parties acknowledge and agree that the purchase of convertible notes of Capsida required by Section 9.2 of the Original Agreement was completed in full and no equity payment is due hereunder with respect to the Original Neurology Rights.", "": "" }, { "Text": "In partial consideration of the Ophthalmology Rights granted by Capsida to AbbVie hereunder, AbbVie or an Affiliate shall purchase Ten Million Dollars (US$10,000,000) of convertible notes of Capsida that would convert to Capsida preferred stock on terms to be set forth in the convertible notes.", "": "" }, { "Text": "9.3 Option Exercise and Additional Capsid Program Payments.", "": "" }, { "Text": "9.3.1 α-syn Program Option Payment. If AbbVie exercises the α-syn Program Option, in partial consideration of the rights granted by Capsida to AbbVie hereunder, and subject to the terms and conditions of this Agreement, no later than thirty (30) days after the date of the Exercise Notice relating to the α-syn Program Option, AbbVie shall pay Capsida a one-time option exercise payment equal to Forty Million Dollars (US$40,000,000).", "": "" }, { "Text": "9.3.2 Tau Program Option Payment. If AbbVie exercises the Tau Capsid Program Option, in partial consideration of the rights granted by Capsida to AbbVie hereunder, and subject to the terms and conditions of this Agreement, no later than thirty (30) days after the date of the Exercise Notice relating to the Tau Program Option, AbbVie shall pay Capsida a one-time option exercise payment equal to Forty Million Dollars (US$40,000,000).", "": "" }, { "Text": "9.3.3 Additional Capsid Program Option. If AbbVie exercises the Additional Capsid Program Option for a Target, in partial consideration of the rights granted by Capsida to AbbVie hereunder, and subject to the terms and conditions of this Agreement, no later than thirty (30) days after the date of the Exercise Notice relating to the Additional Capsid Program Option for such Target (which, for clarity, shall include another Primary Capsid and two additional Back-up Capsids for each such Target), AbbVie shall pay Capsida a one-time per Target option exercise payment equal to Ten Million Dollars (US$10,000,000). For clarity, AbbVie shall pay such option exercise amount once upon the exercise of the Additional Capsid Program Option for α-syn and once upon the exercise of the Additional Program Option for Tau, with total payments under this Section 9.3.3 not to exceed Twenty Million Dollars (US$20,000,000).", "": "" }, { "Text": "9.3.4 Additional Capsid Program Payments. With respect to each additional Licensed Product for a Licensed Target that contains both (a) a Licensed Capsid Program Capsid and (b) an AbbVie Cargo that is different from the AbbVie Cargo contained in the initial IND filing with respect to such Licensed Target, in partial consideration of the rights granted by Capsida to AbbVie hereunder, and subject to the terms and conditions of this Agreement, no later than thirty (30) days after IND effectiveness for such additional Licensed Product, AbbVie shall pay Capsida a payment of Ten Million Dollars (US$10,000,000).", "": "" }, { "Text": "9.3.5 Collaboration Program Option Payment. If AbbVie exercises the Collaboration Program Option, in partial consideration of the rights granted by Capsida to AbbVie hereunder, and subject to the terms and conditions of this Agreement, no later than thirty (30) days after the date of the Exercise Notice relating to the Collaboration Program Option, AbbVie shall pay Capsida a one-time option exercise payment equal to Fifteen Million Dollars (US$15,000,000).", "": "" }, { "Text": "9.3.6 IVT Program Option Payment. If AbbVie exercises the IVT Option, in partial consideration of the rights granted by Capsida to AbbVie hereunder, and subject to the terms and conditions of this Agreement, no later than thirty (30) days after the date of the Exercise Notice relating to the IVT Option, AbbVie shall pay Capsida a one-time option exercise payment equal to Twenty-Five Million Dollars (US$25,000,000).", "": "" }, { "Text": "9.3.7 SCS Program Option Payment. If AbbVie exercises the SCS Option, in partial consideration of the rights granted by Capsida to AbbVie hereunder, and subject to the terms and conditions of this Agreement, no later than thirty (30) days after the date of the Exercise Notice relating to the SCS Option, AbbVie shall pay Capsida a one-time option exercise payment equal to Twenty-Five Million Dollars (US$25,000,000).", "": "" }, { "Text": "9.3.8 IC Program Option Payment. If AbbVie exercises the IC Option, in partial consideration of the rights granted by Capsida to AbbVie hereunder, and subject to the terms and conditions of this Agreement, no later than thirty (30) days after the date of the Exercise Notice relating to the IC Option, AbbVie shall pay Capsida a one-time option exercise payment equal to Twenty-Five Million Dollars (US$25,000,000).", "": "" }, { "Text": "9.3.9 Option Payment Timing. In the event AbbVie exercises an Option more than seventy-five (75) days after AbbVie's receipt of the Final Data Package (or Final Ophthalmology Data Package) with respect to such Option, the applicable Option payment shall be made within fifteen (15) days rather than thirty (30) days after the date of the applicable Exercise Notice.", "": "" }, { "Text": "9.4 α-syn and Tau Milestones. In further consideration of the exclusive rights granted by Capsida to AbbVie under Section 8.1.4 and Section 8.1.5, on the terms and subject to the conditions set forth herein, on a Licensed Target-by-Licensed Target basis for each Licensed Target other than TDP-43, AbbVie shall make the following payments to Capsida (collectively, the \"Milestone Payments\") after the achievement following the Effective Date during the Term of the applicable event set forth below (collectively, the \"Milestone Events\") by the first Licensed Product for each Licensed Target (other than TDP-43) containing a Licensed Capsid Program Capsid and an AbbVie Cargo (each, a \"Milestone Product\").", "": "" }, { "Text": "9.4.1 Development Milestones. Subject to the terms and conditions of this Agreement, AbbVie shall pay to Capsida a Milestone Payment no later than thirty (30) days after the achievement by or on behalf of AbbVie or its Affiliates or Sublicensees of each of the following Milestone Events by the first Milestone Product for each Licensed Target (other than TDP-43) after the Effective Date during the Term, calculated as follows:", "": "" }, { "Text": "Five capsid variants within the top performing capsids from the Pooled Screening efforts can be moved into Reserved Capsids by AbbVie, which selection may be based on the Working Group's determination that their fold-enrichment over benchmark capsids meets TCP criteria. Based on these criteria, any or all of these 5 Reserved Capsids can replace previously selected Reserved Capsids, so the total number of Reserved Capsids remains at 5. From these Reserved Capsids, AbbVie can select up to 3, preferentially representing different capsid families, which will undergo Preliminary Capsid Characterization as described in Step#4 below. In parallel, all Reserved Capsids will move to the Further Capsid Optimization stage as described in Step#5 below.", "": "" }, { "Text": "7.0 Preliminary Individual Capsid Characterization (6-months):", "": "" }, { "Text": "Based upon the data package from capsid selection and pooled screening, AbbVie will decide whether there are capsids that meet or are sufficiently close to the desired TCP to proceed with Preliminary Capsid Characterization.", "": "" }, { "Text": "AbbVie will select up to 3 capsid variants, preferentially representative of different capsid families for Preliminary Capsid Characterization in 3 NHPs and in rodents when applicable. The final study design will be determined by the Working Group considering the inclusion of up to 3 capsids preferentially from different families with an optional AAV9 control arm at one in-life duration (~9-12 NHPs). Preliminary Capsid Characterization will be performed with a reporter protein or AbbVie Cargo (i.e., tool cargo or final cargo if available). Capsida will perform a breadth of analyses (at a selected time point as determined by the Working Group) including multiplicity of infection (MOI) at the DNA level, bulk RNA analysis of AbbVie Cargo expression –in target tissue, cell-type transduction via IHC, immunogenicity of capsid (and cargo if feasible - such as T-cell infiltration into the CNS), toxicity (i.e., liver enzymes, basic blood work), histopathology (e.g. DRGs) and in life-duration of expression. When applicable, Capsida will analyze multiplicity of infection via vector genome DNA sequencing, bulk RNA analysis in CNS cells and cell-type transduction in rodents to support later IND-enabling pharmacology experiments. The collective data generated by this analysis along with the data from the Final Capsid Optimization (Step#5) and subsequent Pooled Screening will inform AbbVie's decision on the selection of a Primary Capsid and two Back-Up Capsids.", "": "" }, { "Text": "8.0 Final Capsid Optimization (6-months):", "": "" }, { "Text": "In parallel with Preliminary Capsid Characterization, unless otherwise determined by the JGC, Capsida will perform final capsid optimization, screening (6 months) and pooled screening (3 months) prior to Final Individual Capsid - Cargo Characterization. Further capsid optimization and screening involves re-differentiation of up to five Reserved Capsids and screening of this library directly in 2-3 juvenile NHPs following an IV administration. Current and planned engineering efforts utilize re-diversification (e.g., diversification of the flanking amino acids) though Capsida will use all reasonable efforts to update the diversification strategy at the time of library generation to the most optimal strategy. The stabilizing libraries will contain AAV9, and any other characterized capsids (e.g., CAP-D1, etc.), as comparator benchmarks. Vector genome residence will be assessed using DNA sequencing in CNS cells and off-target tissues such as the liver and DRGs. In addition, episomal DNA and/or RNA levels will be determined when technically feasible and informative, taking into consideration the size of the library. Variant Optimization libraries will be conducted in parallel in mice and relevant iPSC derived human cell lines unless otherwise determine by the Working Group. Upon completion of this Step#5, AbbVie can select five of the top performing capsid variants from these optimization efforts to be moved into Reserved Capsids by AbbVie, which selection may be based on the Working Group's determination that their fold-enrichment over benchmark capsids meets TCP criteria. These Reserved Capsids will be characterized in the Pooled Screening as described below.", "": "" }, { "Text": "9.0 Final Pooled Screening (3-months; Activities are similar to Step 3)", "": "" }, { "Text": "The top performing variants from the Final Capsid Optimization screening, including any variants previously reserved by AbbVie during the capsid selection process would be moved into Pooled Screening. These capsid variants will be tested in a small pooled experiment with a cargo (e.g. neutral cargo, tool tau / -synuclein cargo or final tau / -synuclein cargo pending availability) to assess DNA biodistribution, bulk RNA expression, bulk protein expression, and gross neuronal transduction (e.g., by IHC) in target tissues in 3 NHPs and in parallel in mice and relevant human iPSC derived cell lines The Pooled Screening study will contain AAV9, and any other characterized capsids (e.g., CAP-D1, etc.) as benchmarks.", "": "" }, { "Text": "The collective data generated during the Final Capsid Optimization (Step #5) and the subsequent Pooled Screening (Step#6), in combination with the data generated from the Preliminary Characterization (Step#4) will inform AbbVie's decision on the selection of a Primary Capsid and two Back-Up Capsids. The Primary Capsid will proceed into the Final Individual Capsid – Cargo Characterization (Step#7) as described below.", "": "" }, { "Text": "10.0 Final Individual Capsid – Cargo Characterization (6-months):", "": "" }, { "Text": "Based upon the data package from capsid selection, pooled screening, and upon selection of a final cargo vector design, AbbVie will select a single variant (i.e., Primary Capsid) to carry forward for Final Individual Capsid - Cargo Characterization in up to 6 NHPs and rodents with Abbvie Cargo. Capsida will perform a breadth of analysis on the selected capsid in NHPs including multiplicity of infection at the DNA level, bulk RNA analysis in the targeted tissues, cell-type transduction via IHC, immunogenicity of capsid and immunogenicity of cargo, toxicity profiles, histopathology, neutralizing antibody profiling in human serum and 3-month durability. The preliminary tox study design (e.g., study duration, doses, inclusion of adult NHPs etc.) will be determined by the Working Group and informed by the data generated in the Preliminary Characterization study (Step#4); typically, this would involve a high and low dose to provide safety data at a therapeutic dose to satisfy the TPP criteria. Capsida will analyze multiplicity of infection at the DNA level, bulk RNA analysis in the targeted tissue and cell-type transduction in rodents to support later IND-enabling pharmacology experiments, unless otherwise determined by the Working Group. The Final Individual Capsid – Cargo Characterization may begin as early as the output of the Preliminary Capsid Characterization (Step#4) or as late as the output of the Pooled Screening data study during Final Capsid Optimization, as determined by the Working Group.", "": "" }, { "Text": "The final data package for the Primary Capsid selected for Final Individual Capsid - Cargo Characterization will be based on the collective data package across capsid engineering, cargo development and optimization, and disease efficacy studies with an ultimate objective of defining a therapeutic window that is satisfactory to move forward to IND Enabling studies. Therefore, some aspects of the TCP may be exceeded, while others may not be fully met. The final data package will be reviewed by the JGC and AbbVie will make the final decision on the Capsid – Cargo combination. Engineering activities will continue pursuant to the research plan for no longer than 2.5 years per target per Research Stage.", "": "" }, { "Text": "All screening and pooled testing steps will be done in juvenile NHPs, as well as the preliminary capsid characterization. The stage at which the capsid -- cargo pairing can be characterized in adult NHPs is the final characterization stage; the Working Group will decide on the age range, depending on animal availability.", "": "" }, { "Text": "10.1.1 Mechanics of Capsid Variant Selection Process", "": "" }, { "Text": "In advance of the JGC meetings, Capsida will aggregate and prepare all relevant available data, based on the stage of engineering, including library screening and/or pooled screening data as described in Appendix 6. This summary will include a rationale for sequence modifications and based on available data sets the relationship to transduction efficiency and any other parameters that are relevant to tissue tropism and biological effects. These data sets will be provided to JGC members as a pre-read. Capsida will facilitate the review and discussion of all data; and include a recommendation of capsid variant(s).", "": "" }, { "Text": "In order to track the top performing capsids, Capsida will maintain an excel spreadsheet which documents and identifies the top performing capsids. This tracker will be reviewed as standard part of agenda at JGC meetings and memorialized in the meeting minutes. The tracker can be stored on a shared file server and made accessible to both parties.", "": "" }, { "Text": "Capsida shall also provide AbbVie with Existing Capsids for use in the Research Program to assess efficacy and / or target engagement studies, in accordance with Capsid Program Research Plan.", "": "" }, { "Text": "10.2 Tau Capsid – Cargo Development", "": "" }, { "Text": "10.2.1 Tau Cargo Development", "": "" }, { "Text": "Tau cargo development will be led by AbbVie and is generally outside of the scope of this research plan with the exception of the vector optimization strategy which will be designed jointly between AbbVie and Capsida. Vector optimization will include assessment of the efficacy of various expression elements, including promoter elements (e.g., ubiquitous and cell-type specific promoters), assessment for single stranded (ss) or self-complementary (sc) AAV packaging, codon optimization, removal of CpG islands, etc. AbbVie will conduct preliminary assessment of the efficacy of various vector designs to inform the Final Individual Capsid – Cargo Characterization by Capsida. Abbvie will transfer the AbbVie Cargo sequence to Capsida for research grade production with different gene regulatory elements. Packaged virus will be transferred back to AbbVie for disease model studies.", "": "" }, { "Text": "AbbVie will be able to provide a tool tau cargo upon commencing the partnership for use in capsid screening and to begin DNA optimization as described below. The final tau cargo is estimated to be completed and transferred to Capsida by 4Q2021, as described in the timeline below.", "": "" }, { "Text": "10.2.2 Dose – Efficacy Relationship in Mice", "": "" }, { "Text": "Dose ranging studies in tau disease models will be conducted by AbbVie for the purpose of establishing a relationship between dose – cargo expression – target engagement - efficacy (i.e., clearance of tau pathology). Disease proof-of-concept can be established using already developed and efficient CNS-targeting rodent AAV capsid surrogates (e.g., AAV.CAP-B10, AAV.CAP-B22, etc.) that will be provided by Capsida. Specifically, the goal will be to relate IV dose with a quantifiable reduction of tau pathology in mouse models of tauopathy (e.g., TauP301S spontaneous aggregation model, P301S seeded aggregation model, htau propagation model). In order to predict the translation from mouse to NHP, AbbVie will provide mouse tissue from the rodent dose ranging studies that will be analyzed by Capsida, using the same assays developed for NHP biodistribution studies. These data will support dose selection for NHP PET studies to be conducted by AbbVie. This information serves dual purposes: 1) refining the efficacy thresholds for TCP, and 2) specifying the biodistribution (cell type, percent transduction, brain region, etc.) necessary by the capsid to reach those thresholds.", "": "" }, { "Text": "10.2.3 Additional NHP Studies for Target Engagement", "": "" }, { "Text": "Activity - Tau cargo 2Q21 3Q21 4Q21 1Q22 2Q22 3Q22 4Q22 1Q23 2Q23", "": "" }, { "Text": "finalize GT modules", "": "" }, { "Text": "confirm mouse efficacy", "": "" }, { "Text": "mouse PK/PD relationship", "": "" }, { "Text": "biomarker develop", "": "" }, { "Text": "NHP model develop, efficacy, biomarker", "": "" }, { "Text": "NHP efficacy dose ranging", "": "" }, { "Text": "AbbVie will work to translate the rodent efficacy model to NHP to incorporate tau aggregate deposition with PET imaging and biomarker detection. Based on the dose response results in mice, AbbVie will do limited dose response in the NHP models to establish target engagement and develop a model for estimating human dose.", "": "" }, { "Text": "10.2.4 Tau Cargo – Capsid Optimization: Selection of Research Product", "": "" }, { "Text": "Vector optimization will be finalized as described in Section 3.3.1 Tau Cargo Development, with AbbVie providing data relating to various vector compositions to efficacy in mouse models at the time of finalizing the gene therapy modules (4Q2021). These elements will be incorporated into the Final Individual Capsid – Cargo Characterization to support candidate selection for further development.", "": "" }, { "Text": "10.2.5 Tau Capsid – Cargo Program (Research Product) Data Package: Reports and Deliverables", "": "" }, { "Text": "Upon completion of the tau capsid – cargo studies, all data sets outlined in Appendix 6 and corresponding reports for the top performing capsid variants (i.e., Reserved Capsids, Primary Capsid and Back-Up Capsids) will be provided to AbbVie. These include:", "": "" }, { "Text": "• Cell-type distribution in NHPs and rodents, after peak expression is established (e.g., IHC, RNA scope or preferred method)", "": "" }, { "Text": "• DNA MOI data in tissues (CNS cells and selected peripheral tissues) in NHPs and / or rodents", "": "" }, { "Text": "• Bulk RNA and / or protein data in targeted tissues and in selected peripheral tissues in NHPs and / or rodents", "": "" }, { "Text": "• Acceptable immunogenicity profile (e.g., nADA) in NHP and low prevalence of preexisting antibodies (<50%) in the target patient population (sufficient sample size to estimate nADA in AD/PD serum sample, but no more 50 samples)", "": "" }, { "Text": "• Toxicity profiles in adult cynomolgus monkey, including clinical pathology and histopathology at peak expression and later (e.g., look at later timepoints for recovery)", "": "" }, { "Text": "• Sequence of the Research Product, Primary and Back-Ups capsids, including patentability and FTO assessment", "": "" }, { "Text": "The Target Product Profile for the Research Product for the tau program has the following attributes.", "": "" }, { "Text": "✓ Meets TCP criteria as agreed by the JGC.", "": "" }, { "Text": "✓ In vivo activity established with evidence of on-target and sustained effect (e.g., clearance of tau aggregates) in a preclinical model (preferably tauopathy model).", "": "" }, { "Text": "✓ Projected human efficacious dose with appropriate preclinical safety profile (acceptable therapeutic window) and feasible dosing regimen for IV administration in human.", "": "" }, { "Text": "✓ Data supportive of translational biomarkers to enable dose selection, target engagement and mode of action in clinical studies.", "": "" }, { "Text": "✓ Packaging efficiency and scalability supportive of generating a suitable dosing regimen for human use via the intended route of administration (i.v.)", "": "" }, { "Text": "✓ Acceptable neutralizing antibody prevalence data in the intended patient population and plan for widespread use in the general population; data supportive of advancement to IND enabling studies.", "": "" }, { "Text": "✓ Manufacturing executable plan in place including process, scalability, analytical methods etc.", "": "" }, { "Text": "10.3 α-Synuclein Capsid – Cargo Development", "": "" }, { "Text": "10.3.1 Α-SYNUCLEIN CARGO DEVELOPMENT", "": "" }, { "Text": "α-synuclein cargo development will be led by AbbVie and is generally outside of the scope of this research plan with the exception of the vector optimization strategy which will be designed jointly between AbbVie and Capsida. Vector optimization will include assessment of the efficacy of various promoter elements (e.g., ubiquitous and cell-type specific promoters), assessment for single stranded (ss) or self-complementary (sc) AAV packaging, codon optimization, removal of CpG islands, etc. AbbVie will conduct preliminary assessment of the efficacy of various vector designs to inform the Final Individual Capsid – Cargo Characterization by Capsida. Abbvie will transfer the AbbVie Cargo sequence to Capsida for research grade production with different gene regulatory elements. Packaged, virus will be transferred back to Abbvie for disease model studies. The α-synuclein cargo is estimated to be finalized and transferred to Capsida by 4Q2022, as described in the activities below. Since the -synuclein cargo development is at an early stage, the tau cargo will be used as a suitable proxy, it is anticipated that components will be highly similar except for the module that confers -synuclein specificity.", "": "" }, { "Text": "10.3.2 Dose – Efficacy Relationship in Mice", "": "" }, { "Text": "Dose ranging studies in α-synuclein disease models will be conducted by AbbVie for the purpose of establishing a relationship between dose – therapeutic protein expression – efficacy (i.e., clearance of α-synuclein pathology). Disease proof-of-concept can be established using already characterized and efficient CNS-targeting rodent AAV capsid surrogates (AAV.CAP-B10, AAV.CAP-B22, etc.) that will be provided by Capsida. Specifically, the goal will be to relate IV dose with a quantifiable reduction of α-synuclein pathology in mouse models of synucleinopathy, which are under development. In order to predict the translation from mouse to NHP, AbbVie will provide mouse tissue from the rodent dose ranging studies that will be analyzed by Capsida, using the same assays developed for NHP biodistribution studies. These data will enable dose selection for NHP PET studies (pending availability of -synuclein PET tracer). This information serves dual purposes: 1) refining the efficacy thresholds for TCP, and 2) specifying the biodistribution (cell type, % transduction, brain region, etc.) necessary by the capsid to reach those thresholds.", "": "" }, { "Text": "10.3.3 Additional NHP Studies for Target Engagement", "": "" }, { "Text": "Activity - a-syn cargo 2Q21 3Q21 4Q21 1Q22 2Q22 3Q22 4Q22 1Q23 2Q23", "": "" }, { "Text": "screen campaign - additional hits", "": "" }, { "Text": "hit select / GT conversion", "": "" }, { "Text": "characterize / selectivity assessment", "": "" }, { "Text": "solubility testing", "": "" }, { "Text": "target engagement", "": "" }, { "Text": "finalize GT modules", "": "" }, { "Text": "confirm mouse efficacy", "": "" }, { "Text": "mouse PK/PD relationship", "": "" }, { "Text": "biomarker develop", "": "" }, { "Text": "NHP model develop, efficacy, biomarker", "": "" }, { "Text": "NHP efficacy dose ranging", "": "" }, { "Text": "In addition, AbbVie will work to translate the rodent efficacy model to NHP to incorporate α-synuclein aggregate deposition with biomarker detection. A PET imaging approach may be considered upon availability of the -synuclein PET ligand. Based on the dose response results in mice, AbbVie will do limited dose response in the NHP model to establish target engagement and develop a model for estimating human dose.", "": "" }, { "Text": "10.3.4 α-synuclein Cargo – Capsid Optimization: Selection of Research Product", "": "" }, { "Text": "Vector optimization will be finalized as described in Section 3.4.1 -synuclein Cargo Development, with AbbVie providing data relating various vector compositions to efficacy in mouse models at the time of finalizing the gene therapy modules (4Q2022). These elements will be incorporated into the Final Individual Capsid – Cargo Characterization to support candidate selection of a further development.", "": "" }, { "Text": "10.3.5 α-synuclein Capsid – Cargo Program (Research Product) Data Package: Reports and Deliverables", "": "" }, { "Text": "Upon completion of the α-synuclein capsid – cargo studies all data sets outlined in Appendix 6 and corresponding reports for the top performing capsids (i.e., Reserved Capsids, Primary Capsid and Back-Up Capsids) will be provided to AbbVie. These include:", "": "" }, { "Text": "• Cell-type distribution in NHPs and rodents, after peak expression is established (e.g., IHC, RNA scope or preferred method)", "": "" }, { "Text": "• DNA MOI data in tissues (CNS cells and selected peripheral tissues) in NHPs and / or rodents", "": "" }, { "Text": "• Bulk RNA and / or protein data in the targeted tissues and in selected peripheral tissues in NHPs and / or rodents", "": "" }, { "Text": "• Acceptable immunogenicity profile (e.g, nADA) in NHP and low prevalence of preexisting antibodies (<50%) in the target patient population (sufficient sample size to estimate nADA in AD/PD serum samples, but not to exceed 50 samples)", "": "" }, { "Text": "• Toxicity profiles in adult cynomolgus monkeys, including clinical pathology and histopathology at peak expression and later (e.g., later timepoints for recovery)", "": "" }, { "Text": "• Sequence of the Research Product, Primary and Back-Ups capsids, including patentability and FTO assessment", "": "" }, { "Text": "The Target Product Profile for the Research Product for the -synuclein program has the following attributes:", "": "" }, { "Text": "✓ Meets TCP criteria as agreed by the JGC.", "": "" }, { "Text": "✓ In vivo activity established with evidence of on-target and sustained effect (e.g., clearance of -synuclein aggregates) in a preclinical model (preferably synucleinopathy model).", "": "" }, { "Text": "✓ Projected human efficacious dose with appropriate preclinical safety profile (acceptable therapeutic window) and feasible dosing regimen for IV administration in human.", "": "" }, { "Text": "✓ Data supportive of translational biomarkers to enable dose selection, target engagement and mode of action in clinical studies.", "": "" }, { "Text": "✓ Packaging efficiency and scalability supportive of generating a suitable dosing regimen for human use via the intended route of administration (i.v.)", "": "" }, { "Text": "✓ Acceptable neutralizing antibody data in the intended patient population and plan for widespread use in the general population supportive of advancement to IND enabling studies.", "": "" }, { "Text": "✓ Manufacturing executable plan in place including process, scalability, analytical methods etc.", "": "" }, { "Text": "11.0 Process and Analytical Development, Scale up, and Supply.", "": "" }, { "Text": "Capsida will provide non-GLP supply (research grade material) for discovery and preclinical research. Upon opt-in, Capsida will initiate process development activities shown below in preparation for GLP-tox material generation and clinical supply.", "": "" }, { "Text": "The FDA guidelines on potency testing for cellular and gene therapy products recommends multiple CMC-related activities to characterize product quality and manufacturing controls, to assure identity, purity, strength (potency), sterility and stability of products to certify lot release and establish product dating and shelf life. These activities would best be performed by Capsida, proximal to the site of manufacture.", "": "" }, { "Text": "The cargo sequence will be transferred to the process development team and synthesized in a plasmid backbone suitable for manufacturing. Positive control material will be generated using the selected capsid and cargo to serve as a reference control for analytical development activities and evaluate process fit in each manufacturing process step. Upstream and downstream development will be implemented to improve productivity, process recovery, and ensure sufficient enrichment of full capsids to meet Target Product Profile. Following the completion of process and analytical development, production will occur at the 50L or greater scale to meet material demands. This final process and methods will be transferred to the GMP and QC groups, respectively.", "": "" }, { "Text": "Some analytical methods, specifically the in vitro potency assay, are known to be complicated for AAV gene therapy products. Regarding the potency assay (used to quantify the transducibility and efficacy of the protein produced from a specific lot of product), AbbVie will develop this assay format for tau andsynuclein. AbbVie will transfer the assay and reagents to Capsida for validation. In addition, an assay may be needed to detect an anti-cargo immune response (distinct from anti-capsid response). AbbVie will take the lead in developing this assay for the tau and syn cargo program. The remaining assays (e.g., capsid empty / full ratio, complete genome packaging, DNA recombination events, purity / contaminants, AAV aggregation, AAV titer, MOI potency assays, etc.) will be developed by Capsida in accordance with FDA guidance.", "": "" }, { "Text": "12.0 Budget (Amounts shown are in '000s)", "": "" }, { "Text": "CAPSID Program Research Plan (Tau and Alpha Syn)", "": "" }, { "Text": "Year 1 Year 2 Year 3 GRAND TOTAL", "": "" }, { "Text": "% of Team Time by Function", "": "" }, { "Text": "Research Total 6% 17% 7%", "": "" }, { "Text": "Technology 33% 33% 14%", "": "" }, { "Text": "Process Development 20% 20% 20%", "": "" }, { "Text": "All Other (Excluding Manufacturing) 6% 7% 3%", "": "" }, { "Text": "FTE Costs by Function", "": "" }, { "Text": "Research 249 888 397 1,533", "": "" }, { "Text": "Technology 904 972 416 2,293", "": "" }, { "Text": "Process Development 689 854 947 2,489", "": "" }, { "Text": "All Other (Excluding Manufacturing) 394 490 229 1,113", "": "" }, { "Text": "TOTAL FTE COST 2,236 3,204 1,989 7,428", "": "" }, { "Text": "Supplies Cost by Function", "": "" }, { "Text": "Research 106 391 165 662", "": "" }, { "Text": "Technology 1,144 1,217 513 2,875", "": "" }, { "Text": "Process Development 1,147 1,255 1,255 3,656", "": "" }, { "Text": "TOTAL SUPPLIES COST 2,397 2,863 1,933 7,193", "": "" }, { "Text": "Outside Spend NHP Experiments", "": "" }, { "Text": "Shared Cost Abbvie Ratio 33% 33% 33%", "": "" }, { "Text": "Shared NHP Experiments 119 7 - 126", "": "" }, { "Text": "Abbvie Only NHP Characterizations 289 1,010 136 1,435", "": "" }, { "Text": "TOTAL NHP COSTS 408 1,017 136 1,561", "": "" }, { "Text": "Overhead Allocations", "": "" }, { "Text": "Travel % 13% 13% 8%", "": "" }, { "Text": "Consulting % 23% 23% 13%", "": "" }, { "Text": "Rent % 23% 23% 13%", "": "" }, { "Text": "IT Expense % 33% 33% 19%", "": "" }, { "Text": "All Other % 7% 7% 4%", "": "" }, { "Text": "Travel $ 13 28 18 59", "": "" }, { "Text": "Consulting $ 408 314 178 899", "": "" }, { "Text": "Rent $ 715 985 567 2,267", "": "" }, { "Text": "IT $ 319 361 232 912", "": "" }, { "Text": "All Other $ (Legal, Finance, Other) 125 120 73 318", "": "" }, { "Text": "Total Overhead 1,580 1,807 1,069 4,456", "": "" }, { "Text": "GRAND TOTAL 6,621 8,891 5,126 20,638", "": "" }, { "Text": "10% of Grand Total 2,064", "": "" }, { "Text": "Memo:", "": "" }, { "Text": "Per Program 3,310 4,445 2,563 10,319", "": "" }, { "Text": "10% Per Program 1,032", "": "" }, { "Text": "Appendix A", "": "" }, { "Text": "** solid (blue) color represents key data available at various stages of the Capsid Generation, Screening & Optimization process (Section 3.2.1)", "": "" }, { "Text": "TCP Criteria - Data deliverables 1. Initial Library Screening 2. Variant Optimization 3. Pooled Screening 4. Preliminary Individual Capsid Characterization 5. Final Capsid Optimization 6. Pooled Screening 7. Final Individual Capsid - Cargo Characterization", "": "" }, { "Text": "1st Round 2nd Round 1st Round 2nd Round 1st Round 2nd Round", "": "" }, { "Text": "Targeted Cell Type", "": "" }, { "Text": "Gross neuronal transduction", "": "" }, { "Text": "Quantified neuronal transduction (all targets)", "": "" }, { "Text": "Quantified oligodendrocyte transduction (A-syn only)", "": "" }, { "Text": "Quantified motor neuron transduction (TDP43only)", "": "" }, { "Text": "Targeted Tissue", "": "" }, { "Text": "NGS DNA level", "": "" }, { "Text": "Benchmarked vector genome residence", "": "" }, { "Text": "DNA MOI", "": "" }, { "Text": "Route of Administration", "": "" }, { "Text": "IV delivery", "": "" }, { "Text": "Expression Level", "": "" }, { "Text": "Bulk RNA level", "": "" }, { "Text": "Bulk protein level", "": "" }, { "Text": "Durability", "": "" }, { "Text": "Tissue De-targeting (including liver and DRG)", "": "" }, { "Text": "Benchmarked vector genome residence", "": "" }, { "Text": "DNA MOI", "": "" }, { "Text": "Bulk RNA level", "": "" }, { "Text": "Bulk protein level", "": "" }, { "Text": "Projected Human Dose", "": "" }, { "Text": "Immunogenicity of capsid", "": "" }, { "Text": "Immunogenicity of cargo", "": "" }, { "Text": "Toxicity", "": "" }, { "Text": "Histopathology", "": "" }, { "Text": "Estimated Therapeutic Window (single dose)", "": "" }, { "Text": "Estimated Therapeutic Window (multi dose)", "": "" }, { "Text": "Manufacturing", "": "" }, { "Text": "Packaging efficiency", "": "" }, { "Text": "Immunogenicity", "": "" }, { "Text": "Immunogenicity of capsid", "": "" }, { "Text": "Immunogenicity of cargo", "": "" }, { "Text": "Neutralization by human patient serum", "": "" }, { "Text": "IP", "": "" }, { "Text": "Patentability/FTO assessment", "": "" }, { "Text": "APPENDIX B", "": "" }, { "Text": "Table 2: TRANSFERRED Materials to be shared from Capsida to Abbvie OR AbbVie to Capsida", "": "" }, { "Text": "Below is a list of items that each Party may transfer to the other Party for use in the Research Program. These items may be transferred as physical samples, nucleotide/amino acid sequences or both. This is not a comprehensive list and may be modified based on needs for executing the Research Plan activities towards achieving the Target Capsid Profile and Target Product Profiles.", "": "" }, { "Text": "Table 2: TRANSFERRED Materials to be shared from", "": "" }, { "Text": "Item Description Comments", "": "" }, { "Text": "CAPSIDA TO ABBVIE", "": "" }, { "Text": "Rodent tool capsids (Existing capsids)", "": "" }, { "Text": "(i) AAV.CAP-B10", "": "" }, { "Text": "(ii) AAV.CAP-B22", "": "" }, { "Text": "Sequences, materials", "": "" }, { "Text": "Packaged with sequence optimized tool anti-tau cargo and tool anti-a-syn cargo", "": "" }, { "Text": "Reserved Capsids _____", "": "" }, { "Text": "_____", "": "" }, { "Text": "_____", "": "" }, { "Text": "_____", "": "" }, { "Text": "Packaged with sequence optimized tool cargo, anti-tau cargo and /or anti-a-syn cargo", "": "" }, { "Text": "ABBVIE TO CAPSIDA", "": "" }, { "Text": "Table 3. CARGO Materials to be Transferred from AbbVie to Capsida", "": "" }, { "Text": "Table 3: CARGO Materials to be Transferred from AbbVie to Capsida", "": "" }, { "Text": "Item Description Comments", "": "" }, { "Text": "Cargo – tau (i) Sequence for tool-anti-tau cargo (ii) Sequence for final anti-tau cargo", "": "" }, { "Text": "Final cargo est 4Q2021-1Q2022", "": "" }, { "Text": "Cargo – -synuclein (i) Sequence for tool-anti--syn cargo (ii) Sequence for final anti--syn cargo", "": "" }, { "Text": "Final cargo est 4Q2022", "": "" }, { "Text": "Expression elements (i) expected regulatory elements", "": "" }, { "Text": "Others", "": "" }, { "Text": "Table 4. CAPSIDS AND RESEARCH PRODUCT MATERIALS - TAU PROGRAM", "": "" }, { "Text": "Table 4: CAPSIDS AND RESEARCH PRODUCT MATERIALS - TAU PROGRAM", "": "" }, { "Text": "Item Description Comments", "": "" }, { "Text": "Reserved Capsids _____", "": "" }, { "Text": "_____", "": "" }, { "Text": "_____", "": "" }, { "Text": "_____", "": "" }, { "Text": "______", "": "" }, { "Text": "as available", "": "" }, { "Text": "Selected Capsids (Primary and Backup Capsids) _____", "": "" }, { "Text": "_____", "": "" }, { "Text": "_____", "": "" }, { "Text": "as available", "": "" }, { "Text": "Research Product candidates (with tool or AbbVie cargo, including rodent versions) _____", "": "" }, { "Text": "_____", "": "" }, { "Text": "_____", "": "" }, { "Text": "_____", "": "" }, { "Text": "as available", "": "" }, { "Text": "Research Product _____", "": "" }, { "Text": "Table 5. CAPSIDS AND RESEARCH PRODUCT MATERIALS: -SYNUCLEIN PROGRAM", "": "" }, { "Text": "Table 5: CAPSIDS AND RESEARCH PRODUCT MATERIALS: -SYNUCLEIN PROGRAM", "": "" }, { "Text": "Item Description Comments", "": "" }, { "Text": "Reserved Capsids _____", "": "" }, { "Text": "_____", "": "" }, { "Text": "_____", "": "" }, { "Text": "_____", "": "" }, { "Text": "______", "": "" }, { "Text": "as available", "": "" }, { "Text": "Selected Capsids (Primary Capsid and Backup Capsids) _____", "": "" }, { "Text": "_____", "": "" }, { "Text": "_____", "": "" }, { "Text": "as available", "": "" }, { "Text": "Research Product candidates (with tool or AbbVie cargo, including rodent versions) _____", "": "" }, { "Text": "_____", "": "" }, { "Text": "_____", "": "" }, { "Text": "_____", "": "" }, { "Text": "as available", "": "" }, { "Text": "Research Product", "": "" }, { "Text": "Exhibit B", "": "" }, { "Text": "Collaboration Program Research Plan", "": "" }, { "Text": "1.0 Background", "": "" }, { "Text": "AbbVie and Capsida are collaborating on research activities aimed at identifying and optimizing capsids using the Capsida Platform to deliver the AbbVie Cargo (\"cargo\") to cells in the central nervous system and / or spinal cord.", "": "" }, { "Text": "Capsida will harness its biologically driven, high-throughput non-human primate (NHP) screening platform and adeno-associated virus (AAV) engineering know-how to develop and validate novel AAVs with increased cargo expression and specificity for CNS cells (e.g., cortical neurons, dopaminergic neurons, oligodendrocytes) in the CNS compared with currently available capsids such as AAV9. Combined with AbbVie's differentiated clearance approach for tau, α-synuclein, and TDP43, the two organizations will collaborate to create innovative gene therapies for debilitating neurodegenerative disorders.", "": "" }, { "Text": "2.0 Research Plan Scope and Framework", "": "" }, { "Text": "AbbVie and Capsida have agreed to a Research Plan for the development of Capsid (\"capsid\") – cargo combinations for three targets: tau, α-synuclein and TDP43. This Research Plan (Collaboration Program Research Plan) outlines activities and estimated timelines to be conducted by Capsida or AbbVie, as specified below, for the TPD43 program. These activities are designed to generate and optimize capsids using the Capsida platform to deliver AbbVie Cargo to the relevant CNS cells and / or spinal cord cells. The activities focus on the development and engineering of capsids directed towards a Target Capsid Profile (TCP) for TDP43. The TCP may be subject to change and will be further informed and refined based on preclinical disease biology and as data are generated in the course of the collaboration or based on scientific advances in the field. Changes to the TCP must be approved by the Joint Governance Committee (JGC) in accordance with the Agreement. It is expected that the JGC will discuss, review, and approve amendments to this Research Plan on a periodic basis based on scientific data, developments in the field, or other matters that may arise, in each case as set forth in the Agreement. The JGC will also monitor workflow, resource allocation, timelines, and overall progress under this Research Plan.", "": "" }, { "Text": "The Collaboration Program Research Plan will be focused on the generation of a fully characterized capsid – cargo combination for the TDP43 target. Capsida will be responsible for all activities within such plan as described in this document and in the Collaboration Program Research Plan Overview (Figure 2) below, with the exception of the generation and initial characterization of the TDP43 cargo which will be AbbVie's responsibility.", "": "" }, { "Text": "Figure 2: Collaboration Program Research Plan Overview", "": "" }, { "Text": "Figure 2: Collaboration Program Research Plan Overview", "": "" }, { "Text": "3.0 Collaboration Program", "": "" }, { "Text": "3.1 Initial Target Capsid Profile for TDP43", "": "" }, { "Text": "The overarching goal of the collaboration is to achieve a capsid profile with characteristics as outlined in Table 6 below aimed at delivering TDP43 cargo to relevant cell types in the CNS and spinal cord. The activities focus on the engineering of capsids directed towards a Target Capsid Profile for TDP43, which may be subject to change – informed and refined based on disease biology understanding and data generated during the collaboration. Changes to the TCP must be approved by the JGC.", "": "" }, { "Text": "Table 6. Initial Target Capsid Profile (TCP) for TDP43 Target", "": "" }, { "Text": "Table 6: Initial Target Capsid Profile (TCP) for TDP43 Target", "": "" }, { "Text": "TDP43 Capsid", "": "" }, { "Text": "Targeted Cell Type* >80% transduction of motor neurons (upper motor neurons in the brain and lower motor neurons in the spinal cord) in the targeted tissue", "": "" }, { "Text": "Targeted Tissue Cortex, Spinal cord", "": "" }, { "Text": "Route of Administration IV route is required (with volume and titer feasible for IV dosing and consistent with FDA guidelines)", "": "" }, { "Text": "Expression Level Equivalent or improved expression of RNA and / or protein as compared to efficacious expression levels observed in preclinical models using intraparenchymal or IV administration of reference capsids (e.g., AAV9, AAV.CAP-B10, AAV.CAP-B22)", "": "" }, { "Text": "Tissue De-targeting >10-fold improved de-targeting of DRGs and liver (as compared to AAV9)", "": "" }, { "Text": "Projected Human Dose Capsid-cargo combination safe in non-clinical safety studies in adult cynomolgus monkeys, providing an acceptable therapeutic window", "": "" }, { "Text": "Manufacturing Improved packaging efficiency over AAV9", "": "" }, { "Text": "Immunogenicity Neutralizing antibody profile similar or better than AAV9 using industry standards", "": "" }, { "Text": "IP Novel capsid – cargo combination for which IP can be filed", "": "" }, { "Text": "*The desired percentage of transduction will be determined by the rodent efficacy studies. A lower transduction rate may be acceptable if supported by data from such studies; in such case, TCP may be amended as set forth in the Agreement.", "": "" }, { "Text": "3.2 ALS Preclinical", "": "" }, { "Text": "These activities will be led by Capsida, except for TDP43 cargo development which is AbbVie's responsibility (out of scope for this document). In addition, AbbVie will provide experimental support and scientific consultation to support execution of these studies.", "": "" }, { "Text": "3.2.1 In vitro and In vivo models", "": "" }, { "Text": "In vitro: Establish relevant biochemical and cellular assays to evaluate TDP43 biology. Characterization in neuronal / iPSC assays will be conducted unless otherwise determined by the Working Group. Expectation is to mimic rodent models by making the nuclear localization sequence defective in patient iPSC-derived neurons (potentially differentiated to motor neurons), leading to aggravated TDP43 pathology in the cytoplasm as opposed to correct localization to the nucleus. Tool and final TDP43 cargo provided by AbbVie will be characterized in these in vitro models by Capsida.", "": "" }, { "Text": "In vivo: Establish relevant in vivo models to evaluate TDP43 pharmacology. In vivo studies will aim at relating dose- transduction efficiency – cargo expression – target engagement – TDP43 pathology. Preferred model is currently rNLS8 model expressing hTDP43 with defective nuclear localization signal, but other in vivo models will be considered for establishment of proof-of-principle. Mouse efficacy of tool TDP43 cargo will be confirmed in this model.", "": "" }, { "Text": "3.2.2 Translational Biomarker Activities", "": "" }, { "Text": "Develop a Translational / Biomarker data sets to advance TDP-43 program for ALS. (e.g., CSF, plasma biomarkers (expression, target engagement, pharmacodynamics etc.))", "": "" }, { "Text": "3.3 Capsid Engineering, Screening and Optimization", "": "" }, { "Text": "Drug substance activities assume 3 parallel efforts: capsid engineering, vector optimization (e.g., promoter/ Gene Regulatory Elements (GRE)), and cargo development (out of scope for this document).", "": "" }, { "Text": "All capsid engineering will be conducted by Capsida. There will be frequent and ad hoc communication and scientific dialogue between the Working Group while engineering is ongoing, gated by availability of relevant data. Per the governance framework, on a quarterly basis, the JGC will discuss and review available data generated by the process outlined below. This does not limit the discussion of scientific findings to the formal governance setting; informal discussions through email or phone for scientific exchange is expected.", "": "" }, { "Text": "3.3.1 Selection Process of New Capsids – TDP43", "": "" }, { "Text": "4.0 Initial Library Screening (6-months):", "": "" }, { "Text": "Initial library screening efforts (i.e., de novo) begin with peptide substitutions and / or insertions and capsid variants are screened directly in 2-3 juvenile NHPs following an IV administration. Current and planned engineering efforts utilize 7-mer insertions after AA588 in AAV9, though Capsida will use all reasonable efforts to update the diversification strategy at the time of library generation to the most optimal strategy. Next Generation Sequencing (NGS) data at the DNA level in CNS cells and relevant off-target tissues such as the liver and dorsal root ganglion cells (DRGs) will be generated, and the top performing variants, (i.e., those that demonstrate high vector genome residence in CNS cells and low vector genome residence in off target tissues), will be selected for a second round of screening as determined by the Working Group. In the event that ongoing process development suggests RNA and / or episomal DNA screening provides value to the first round of screening, data from either or both methods will be added to the selection criteria for selecting variants to carry forward to second-round selection.", "": "" }, { "Text": "Second-round screening will be conducted in 2-3 NHPs. The second-round library will contain AAV9, and any other characterized capsids (e.g., CAP-D1, etc.) as comparator benchmarks. Vector genome residence will be assessed using DNA sequencing in CNS cells and off-target tissues such as the liver and DRGs. In addition, episomal DNA and / or RNA levels will be determined when feasible and informative, taking into consideration the size of the second-round library. Second-round confirmatory screening will be conducted in parallel in mice and relevant human iPSC derived cell lines unless when not technically feasible.", "": "" }, { "Text": "Each of the two screening rounds in this Step #1 take 3-months to conduct, leading to a total period of 6-months. Five of the top performing variant capsids from this initial screening effort can be moved by AbbVie into Reserved Capsids and / or Pooled Screening, which decision may be made by the Working Group's determination that their fold-enrichment in CNS cells versus off target tissues over benchmark comparator capsids meets TCP criteria. In parallel, Variant Optimization will be performed on the top performing variant capsid(s), as outlined below.", "": "" }, { "Text": "5.0 Variant Optimization (6-months):", "": "" }, { "Text": "Top performing capsids from the Initial Library Screening will be moved into re-diversification and stabilizing library screening in 2-3 NHPs, aimed at increasing efficacy and / or specificity in CNS cells. Scanning (e.g., scanning 3-mer diversification) is currently being utilized for Variant Optimization purposes, though Capsida will use all reasonable efforts to update the diversification strategy at the time of library generation to the most optimal strategy. The stabilizing libraries will contain AAV9, and any other characterized capsids (e.g., CAP-D1, etc.), as comparator benchmarks. Vector genome residence will be assessed using DNA sequencing in CNS cells and off-target tissues such as the liver and DRGs. In addition, episomal DNA and / or RNA levels will be determined when technically feasible and informative as determined by the working group, taking into consideration the size of the library. Stabilizing library confirmatory screening will be conducted in parallel in mice and relevant human iPSC derived cell lines, unless otherwise determined by the Working Group.", "": "" }, { "Text": "Second-round screening of Variant Optimization libraries will be conducted in 2-3 NHPs. The second-round library will contain AAV9, and any other characterized capsids (e.g., CAP-D1, etc.) as benchmarks. Enrichment data will be read out at the DNA level in target tissues and off-target tissues such as the liver and DRGs. In addition, episomal DNA and / or RNA levels will be determined when feasible and informative, taking into consideration the size of the second-round library. Second-round confirmatory screening will be conducted in parallel in mice and relevant human iPSC derived cell lines unless otherwise determined by the Working Group.", "": "" }, { "Text": "Each of the two screening rounds during Step#2 take 3-months to conduct (total period of 6-months). Five capsid variants within the top performing capsids can be moved by AbbVie into Reserved Capsids and / or Pooled Screening, which decision may be made by the Working Group's determination that their fold-enrichment in CNS cells versus off target tissues over benchmark comparator capsids meets TCP criteria. Any or all of these 5 capsid variants can replace previously selected Reserved Capsids, so the total number of Reserved Capsids remains at five (5).", "": "" }, { "Text": "6.0 Pooled Screening (3-months):", "": "" }, { "Text": "The top performing capsid variants from Initial Library Screening and from the Variant Optimization screening, including the 5 Reserved Capsids selected by AbbVie in the capsid selection process, will be tested in a small pooled screening experiment with a cargo (e.g., neutral cargo, tool TDP43 cargo or final TDP43 cargo pending availability) to assess DNA biodistribution, bulk RNA expression, bulk protein expression, and gross neuronal transduction (e.g., by IHC) in target tissues in 3 NHPs and in parallel in mice and relevant human iPSC derived cell lines. The pooled study will contain AAV9, and any other characterized capsids (e.g., CAP-D1, etc.), agreed by the JGC as benchmarks.", "": "" }, { "Text": "Five capsid variants within the top performing capsids from the Pooled Screening efforts can be moved by AbbVie into Reserved Capsids, which decision may be made by the Working Group's determination that their fold-enrichment in CNS cells versus off target tissues over benchmark comparator capsids meets TCP criteria. Based on these criteria, any or all of these 5 capsid variants can replace previously selected Reserved Capsids, so the total number of Reserved Capsids remains at 5. From these Reserved Capsids, AbbVie can select up to three (3), preferentially representing different capsid families, which will undergo Preliminary Capsid Characterization as described in Step#4 below. In parallel, all Reserved Capsids will move to the Final Capsid Optimization stage as described in Step#5 below.", "": "" }, { "Text": "7.0 Preliminary Individual Capsid Characterization (6-months):", "": "" }, { "Text": "Based upon the data package from capsid selection and pooled screening, AbbVie will decide whether there are capsids that meet or are sufficiently close to the desired TCP to proceed with Preliminary Capsid Characterization.", "": "" }, { "Text": "AbbVie will select up to 3 capsid variants, preferentially representative of different capsid families for Preliminary Capsid Characterization in 3 NHPs and in rodents when applicable. The final study design will be determined by the Working Group considering the inclusion of up to 3 capsids preferentially from different families with an optional AAV9 control arm at one in-life duration (~9-12 NHPs). Preliminary Capsid Characterization will be performed with a reporter protein or AbbVie Cargo (i.e., tool TDP43 cargo or final TDP43 cargo if available). Capsida will perform a breadth of analyses (at a selected time point as determined by the Working Group) including multiplicity of infection (MOI) at the DNA level, bulk RNA analysis of AbbVie cargo expression –in target tissue, cell-type transduction via IHC, immunogenicity of capsid (and cargo if feasible - such as T-cell infiltration into the CNS), toxicity (i.e., liver enzymes, basic blood work), histopathology (e.g., DRGs) and in life-duration of expression. When applicable, Capsida will analyze multiplicity of infection via vector genome DNA sequencing, bulk RNA analysis in CNS cells and cell-type transduction in rodents to support later IND-enabling pharmacology experiments. The data generated by this analysis along with the data from the Final Capsid Optimization (Step#5) and subsequent Pooled Screening will inform AbbVie's decision on the selection of a Primary Capsid and two Back-Up Capsids.", "": "" }, { "Text": "8.0 Final Capsid Optimization (6-months):", "": "" }, { "Text": "In parallel with Preliminary Capsid Characterization, unless otherwise determined by the JGC, Capsida will perform final capsid optimization, screening (6 months) and pooled screening (3 months) prior to Final Individual Cargo - Capsid Characterization. Further capsid optimization and screening involves re-differentiation of up to five Reserved Capsids and screening of this library directly in 2-3 juvenile NHPs following an IV administration. Current and planned engineering efforts utilize re-diversification (e.g,. diversification of the flanking amino acids) though Capsida will use all reasonable efforts to update the diversification strategy at the time of library generation to the most optimal strategy. The stabilizing libraries will contain AAV9, and any other characterized capsids (e.g., CAP-D1, etc.), as comparator benchmarks. Vector genome residence will be assessed using DNA sequencing in CNS cells and off-target tissues such as the liver and DRGs. In addition, episomal DNA and / or RNA levels will be determined when technically feasible and informative, taking into consideration the size of the library. Variant Optimization libraries will be conducted in parallel in mice and relevant iPSC derived human cell lines unless otherwise determine by the Working Group. Upon completion of this Step#5, AbbVie can select five of the top performing capsid variants that can be moved into Reserved Capsids, which decision may be made by the Working Group's determination that their fold-enrichment in CNS cells versus off target tissues over benchmark comparator capsids meets TCP criteria. These Reserved Capsids will be characterized in the Pooled screening as described below.", "": "" }, { "Text": "9.0 Final Pooled Screening (3-months; Activities similar to Step 3):", "": "" }, { "Text": "The top performing variants from the Final Capsid Optimization screening, including any variants previously reserved by AbbVie during the capsid selection process would be moved into Pooled Screening, These capsid variants will be tested in a small pooled screening experiment with a cargo (e.g., neutral cargo, tool TDP43 cargo or final TDP43 cargo pending availability) to assess DNA biodistribution, bulk RNA expression, bulk protein expression, and gross neuronal transduction (e.g., by IHC) in target tissues in 3 NHPs and in parallel in mice and relevant human iPSC derived cell lines. The Pooled Screening study will contain AAV9, and any other characterized capsids (e.g., CAP-D1, etc.) as benchmarks.", "": "" }, { "Text": "The collective data generated during the Final Capsid Optimization (Step#5) and the subsequent Pooled Screening (Step#6), in combination with the data generated from the Preliminary Characterization (Step#4) will inform AbbVie's decision on the selection of a Primary Capsid and two Back-Up Capsids. The Primary Capsid will proceed into the Final Individual Capsid – Cargo Characterization (Step#7) as described below.", "": "" }, { "Text": "10.0 Final Individual Capsid – Cargo Characterization (6-months):", "": "" }, { "Text": "Based upon the data package from capsid selection, pooled screening, and upon selection of a final cargo vector design, AbbVie will select a single variant (i.e., Primary Capsid) to carry forward for Final Individual Capsid – Cargo Characterization in up to 6 NHPs and rodents with AbbVie cargo. Capsida will perform a breadth of analysis on the selected capsid in NHPs including multiplicity of infection at the DNA level, bulk RNA analysis in the targeted tissues, cell-type transduction via IHC, immunogenicity of capsid and immunogenicity of cargo, toxicity profiles, histopathology, neutralizing antibody profiling in human serum and 3-month durability. The preliminary tox study design (e.g., study duration, doses, inclusion of adult NHPs etc.) will be determined by the Working Group and informed by the data generated in the Preliminary Characterization study (Step#4); typically, this would involve a high and low dose to provide safety data at a therapeutic dose to satisfy the TPP criteria. Capsida will analyze multiplicity of infection at the DNA level, bulk RNA analysis in the targeted tissue and cell-type transduction in rodents to support later IND-enabling pharmacology experiments, unless otherwise determined by the Working Group. The Final Individual Capsid – Cargo- Characterization may begin as early as the output of the Preliminary Capsid Characterization (Step#4) or as late as the output of the Pooled Screening study during Final Capsid Optimization, as determined by the Working Groups.", "": "" }, { "Text": "The final data package for the Primary Capsid selected for Final Individual Capsid - Cargo Characterization will be based on the collective data package across capsid engineering, cargo development and optimization, and disease efficacy studies with an ultimate objective of defining a therapeutic window that is satisfactory to move forward to IND Enabling studies. Therefore, some aspects of the TCP may be exceeded, while others may not be fully met. The final data package will be reviewed by the JGC and AbbVie will make the final decision on the Capsid – Cargo combination. Engineering activities will continue pursuant to the research plan for no longer than 2.5 years per target.", "": "" }, { "Text": "All screening and pooled testing steps will be done in juvenile NHPs, as well as the preliminary capsid characterization. The stage at which the capsid -- cargo pairing can be characterized in adults is the final characterization stage; the Working Group will decide on the age range, depending on animal availability.", "": "" }, { "Text": "10.1.1 Mechanics of Capsid Variant Selection Process", "": "" }, { "Text": "In advance of the JGC meetings, Capsida will aggregate and prepare all relevant available data, based on stage of engineering, including library screening and/or pooled screening data, as summarized in Appendix 6. This summary will include rationale for sequence modifications and based on available datasets, the relationship to transduction efficacy and any other parameters relevant to tissue tropism and biological effects. These datasets will be provided to JGC members as a pre-read. Capsida will facilitate the review and discussion of all data; and include a recommendation of capsid variant(s).", "": "" }, { "Text": "In order to track the top performing capsids, Capsida will maintain an excel spreadsheet which documents and identifies the top performing capsids. This tracker will be reviewed as standard part of agenda at JGC meetings and memorialized in the meeting minutes. The tracker can be stored on a shared file server and made accessible to both parties.", "": "" }, { "Text": "10.2 TDP43 Capsid – Cargo Characterization", "": "" }, { "Text": "10.2.1 TDP43 Cargo Development", "": "" }, { "Text": "AbbVie is developing a tool TDP43 cargo and the final TDP43 cargo, which activities are outside the scope of the research plans. The tool TDP43 cargo will be verified in solubility and target-engagement assays before transferring to Capsida. Using this tool TDP43 cargo, AbbVie and Capsida jointly will design a vector optimization strategy. Capsida will be responsible for assessing the efficacy of various promoter elements (e.g., ubiquitous and cell-type specific promoters), assessing single stranded (ss) or self-complementary (sc) AAV packaging, codon optimization, removal of CpG islands, etc. A preliminary assessment of the efficacy of various vectors designs will be conducted, resulting in the choice of a finalized vector design to be used for pooled screening of novel engineered capsids. In parallel, AbbVie will conduct a screening campaign to identify novel TDP43 cargo. Similarly, this cargo will be validated in solubility and target-engagement assays with an expected delivery of final TDP43 cargo by 4Q2022. This final TDP43 cargo will be combined with optimized vector design to perform mouse / NHP Final Individual Capsid - Cargo Characterization for candidate selection for further development.", "": "" }, { "Text": "10.2.2 Dose – Efficacy Relationship Studies in Mice", "": "" }, { "Text": "Capsida Activity - TDP-43 4Q21 1Q22 2Q22 3Q22 4Q22 1Q23 2Q23 3Q23 4Q23 1Q24", "": "" }, { "Text": "Receive tool GT from AbbVie", "": "" }, { "Text": "Confirm mouse efficacy", "": "" }, { "Text": "Biomarker developent", "": "" }, { "Text": "Preliminary Individual Capsid Characterization", "": "" }, { "Text": "Mouse PK/PD relationship", "": "" }, { "Text": "Receive final GT from AbbVie", "": "" }, { "Text": "Final Individual Capsid - Cargo Characterization", "": "" }, { "Text": "NHP studies for target engagement", "": "" }, { "Text": "Dose ranging studies in TDP43 disease models will be conducted by Capsida, or contracted to CRO (e.g., Psychogenics), for the purpose of establishing a relationship between dose – cargo expression – efficacy (i.e., clearance of TDP43 pathology). Disease proof-of-concept can be established using already developed and efficient CNS-targeting rodent AAV capsid surrogates (e.g., AAV.CAP-B10, AAV.CAP-B22, etc.). Specifically, the goal will be to relate IV dose with a quantifiable reduction of TDP43 pathology in mouse models of ALS (e.g., rNLS8 mice with doxycycline-suppressible expression of hTDP-43 harboring a defective nuclear localization sequence). Given the issues of uncertain translatability to human disease, Capsida should plan to test more than one TDP43 animal model. In order to predict the translation from mouse to NHP, tissue from the rodent dose response studies will be analyzed by Capsida using the same assays developed for NHP biodistribution studies. These data will enable dose selection for NHP target-engagement studies. This information serves dual purposes: 1) refining the efficacy thresholds for TCP, and 2) specifying the biodistribution (cell type, % transduction, brain region, etc.) necessary by the capsid to reach those thresholds.", "": "" }, { "Text": "Some of the parameters to be decided by the Working Group includes:", "": "" }, { "Text": "▪ Expected study duration = To be determined (TBD) based on dose-efficacy relationship in mice studies and choice of disease model (e.g., for rNLS8 model = 16 weeks, with dox removed at 5 weeks of age and timing of AAV administration TBD by previous studies).", "": "" }, { "Text": "▪ Biodistribution of capsid and TDP43-cargo transgene evaluated in all relevant tissues.", "": "" }, { "Text": "▪ TDP43 pathology and neuroinflammation assessed across target CNS regions as relevant in chosen disease model.", "": "" }, { "Text": "▪ Survival time, body weight, and disease behavior phenotypes assessed as relevant in chosen disease model.", "": "" }, { "Text": "▪ Compound muscle action potentials assessed as relevant in chosen disease model.", "": "" }, { "Text": "▪ Assessment of target engagement biomarker.", "": "" }, { "Text": "10.2.3 Additional NHP Studies for Target Engagement", "": "" }, { "Text": "Activity - TDP-43 cargo 2Q21 3Q21 4Q21 1Q22 2Q22 3Q22 4Q22 1Q23 2Q23", "": "" }, { "Text": "design tool GT", "": "" }, { "Text": "solubility testing", "": "" }, { "Text": "target engagement", "": "" }, { "Text": "if success - transfer to Capsida", "": "" }, { "Text": "screen campaign - additional hits", "": "" }, { "Text": "hit select / GT conversion", "": "" }, { "Text": "characterize / selectivity assessment", "": "" }, { "Text": "solubility testing", "": "" }, { "Text": "target engagement", "": "" }, { "Text": "Capsida will work to translate the biomarker discovery from the rodent efficacy model to NHP to incorporate metrics for target engagement efficacy, should NHP model exist and as determined by the Working Group. Based on the dose response results in mice and following the Final Individual Capsid – Cargo Characterization, a dose-response study will be performed in the NHP model to establish target engagement and develop a model for estimating human dose. Capsida will monitor the availability of TDP43 PET tracers for potential utility to the TDP43 program.", "": "" }, { "Text": "10.2.4 TDP43 Cargo – Capsid characterization: Selection of Research Product", "": "" }, { "Text": "Vector optimization will be finalized as described in Section 3.4.1 TDP43 Cargo Development, with data relating various vector compositions to efficacy in mouse models arriving at a similar time as finalized TDP43 cargo (4Q2022). To avoid repeating studies, these elements will be incorporated into the screening and biodistribution studies as early as possible and carry into the Final Individual Capsid - Cargo Characterization to support candidate selection towards further development.", "": "" }, { "Text": "10.2.5 TDP43 Capsid – Cargo Program (Research Product) Data Package: Reports and Deliverables", "": "" }, { "Text": "Upon completion of the TDP43 capsid – cargo studies, data sets outlined in Appendix 6 and the corresponding reports for the top performing capsids (i.e., Reserved Capsids, Primary Capsid and Back-Up Capsids) will be provided to AbbVie. These include:", "": "" }, { "Text": "• In-vitro validation of TDP43 cargo in human iPSC-derived neurons with TDP43 pathology", "": "" }, { "Text": "• Rodent TDP43 model proof-of-concept data confirming efficacy", "": "" }, { "Text": "• Mouse/NHP data supporting validation of target-engagement biomarker for TDP43 cargo", "": "" }, { "Text": "• Cell-type distribution in NHPs and rodents after peak expression established (e.g., IHC, RNA scope or preferred method)", "": "" }, { "Text": "• DNA MOI data in tissues (CNS cells and selected peripheral tissues) in NHPs and / or rodents", "": "" }, { "Text": "• Bulk RNA and / or protein data in targeted tissues and in selected peripheral tissues in NHPs and / or rodents", "": "" }, { "Text": "• Acceptable immunogenicity profile in NHP and low prevalence of preexisting antibodies (<50%) in the target patient population (sufficient sample size to estimate nADA in ALS serum samples, but not to exceed 50 samples)", "": "" }, { "Text": "• Toxicity profiles in adult cynomolgus monkeys, including clinical pathology and histopathology at peak expression and later (e.g., later timepoints for recovery)", "": "" }, { "Text": "• Sequence of the Research Product, Primary and Back-up capsids including patentability and FTO assessment", "": "" }, { "Text": "The Target Product Profile for the Research Product for the TDP43 program has the following attributes:", "": "" }, { "Text": "✓ Meets TCP criteria as agreed by JGC", "": "" }, { "Text": "✓ In vivo activity established with evidence of on-target effect (e.g., ALS correlation) in a preclinical model (preferably TDP43 model)", "": "" }, { "Text": "✓ Projected human efficacious dose with appropriate preclinical safety profile (acceptable therapeutic window) and feasible dosing regimen for IV administration in human", "": "" }, { "Text": "✓ Data supportive of translational biomarkers to enable dose selection, target engagement and mode of action in clinical studies", "": "" }, { "Text": "✓ Packaging efficiency and scalability supportive of generating a suitable dosing regimen for human use via the intended route of administration (i.v.)", "": "" }, { "Text": "✓ Acceptable neutralizing antibody data and plan for widespread use in the intended patient population supportive of advancement to IND enabling studies", "": "" }, { "Text": "✓ Manufacturing executable plan in place including process, scalability, analytical methods etc.", "": "" }, { "Text": "11.0 Process and Analytical Development, Scale up, and Supply", "": "" }, { "Text": "Capsida will provide non-GLP supply (research grade material) for discovery and preclinical research. Upon opt-in, Capsida will initiate process development activities shown below in preparation for GLP-tox material generation and clinical supply.", "": "" }, { "Text": "The FDA guidelines on potency testing for cellular and gene therapy products recommends multiple CMC-related activities to characterize product quality and manufacturing controls, to assure identity, purity, strength (potency), sterility and stability of products to certify lot release and establish product dating and shelf life. These activities would best be performed by Capsida, proximal to the site of manufacture.", "": "" }, { "Text": "The cargo sequence will be transferred to the process development team and synthesized in a plasmid backbone suitable for manufacturing. Positive control material will be generated using the selected capsid and cargo to serve as a reference control for analytical development activities and evaluate process fit in each manufacturing process step. Upstream and downstream development will be implemented to improve productivity, process recovery, and ensure sufficient enrichment of full capsids to meet Target Product Profile. Following the completion of process and analytical development, production will occur at the 50L or greater scale to meet material demands. This final process and methods will be transferred to the GMP and QC groups, respectively.", "": "" }, { "Text": "Some analytical methods, specifically the in vitro potency assay, are known to be complicated for AAV gene therapy products. Regarding the potency assay (used to quantify the transducibility and efficacy of the protein produced from a specific lot of product), Capsida will take primary responsibility for developing the potency assay for TDP43. In addition, an assay may be needed to detect an anti-cargo immune response (distinct from anti-capsid response). Capsida will take the lead in developing this assay as well for the TDP43 program. The remaining assays (e.g., capsid empty / full ratio, complete genome packaging, DNA recombination events, purity / contaminants, AAV aggregation, AAV titer, MOI potency assays, etc.) will be developed by Capsida in accordance with FDA guidance.", "": "" }, { "Text": "12.0 Collaboration Program Research Plan Budget (note: numbers below in '000s)", "": "" }, { "Text": "Collaboration Program Research Plan (TDP43 only)", "": "" }, { "Text": "Year 1 Year 2 Year 3 GRAND TOTAL", "": "" }, { "Text": "% of Team Time by Function", "": "" }, { "Text": "Research Total 12% 17% 7%", "": "" }, { "Text": "Technology 17% 17% 7%", "": "" }, { "Text": "Process Development 10% 10% 10%", "": "" }, { "Text": "All Other (Excluding Manufacturing) 3% 3% 2%", "": "" }, { "Text": "FTE Costs by Function", "": "" }, { "Text": "Research 474 888 397 1,758", "": "" }, { "Text": "Technology 452 486 208 1,146", "": "" }, { "Text": "Process Development 344 427 473 1,245", "": "" }, { "Text": "All Other (Excluding Manufacturing) 197 245 115 557", "": "" }, { "Text": "TOTAL FTE COST 1,468 2,046 1,193 4,706", "": "" }, { "Text": "Supplies Cost by Function", "": "" }, { "Text": "Research 235 391 165 791", "": "" }, { "Text": "Technology 572 609 257 1,437", "": "" }, { "Text": "Process Development 573 627 627 1,828", "": "" }, { "Text": "TOTAL SUPPLIES COST 1,381 1,627 1,049 4,057", "": "" }, { "Text": "Outside Spend NHP Experiments", "": "" }, { "Text": "Shared Cost Abbvie Ratio", "": "" }, { "Text": "Shared NHP Experiments 60 4 - 63", "": "" }, { "Text": "Abbvie Only NHP Characterizations 145 505 68 718", "": "" }, { "Text": "NHP Target Engagement - - 263 263", "": "" }, { "Text": "TOTAL NHP COSTS 204 509 331 1,043", "": "" }, { "Text": "Mouse Dose Efficacy Relationship 111 333 56 500", "": "" }, { "Text": "Biomarker Studies 111 333 56 500", "": "" }, { "Text": "Overhead Allocations", "": "" }, { "Text": "Travel % 7% 7% 4%", "": "" }, { "Text": "Consulting % 12% 12% 7%", "": "" }, { "Text": "Rent % 12% 12% 7%", "": "" }, { "Text": "IT Expense % 17% 17% 9%", "": "" }, { "Text": "All Other % 3% 3% 2%", "": "" }, { "Text": "Travel $ 7 14 9 30", "": "" }, { "Text": "Consulting $ 204 157 89 450", "": "" }, { "Text": "Rent $ 358 492 284 1,134", "": "" }, { "Text": "IT $ 159 181 116 456", "": "" }, { "Text": "All Other $ (Legal, Finance, Other) 62 60 37 159", "": "" }, { "Text": "Total Overhead 790 904 535 2,228", "": "" }, { "Text": "GRAND TOTAL 4,065 5,751 3,218 13,034", "": "" }, { "Text": "10% of Grand Total 1,303", "": "" }, { "Text": "13.0 Appendix", "": "" }, { "Text": "** solid (blue) color represents key data available at various stages of the Capsid Generation, Screening & Optimization process Section 3.3.1).", "": "" }, { "Text": "TCP Criteria - Data deliverables 1. Initial Library Screening 2. Variant Optimization 3. Pooled Screening 4. Preliminary Individual Capsid Characterization 5. Final Capsid Optimization 6. Pooled Screening 7. Final Individual Capsid - Cargo Characterization", "": "" }, { "Text": "1st Round 2nd Round 1st Round 2nd Round 1st Round 2nd Round", "": "" }, { "Text": "Targeted Cell Type", "": "" }, { "Text": "Gross neuronal transduction", "": "" }, { "Text": "Quantified neuronal transduction (all targets)", "": "" }, { "Text": "Quantified oligodendrocyte transduction (A-syn only)", "": "" }, { "Text": "Quantified motor neuron transduction (TDP43only)", "": "" }, { "Text": "Targeted Tissue", "": "" }, { "Text": "NGS DNA level", "": "" }, { "Text": "Benchmarked vector genome residence", "": "" }, { "Text": "DNA MOI", "": "" }, { "Text": "Route of Administration", "": "" }, { "Text": "IV delivery", "": "" }, { "Text": "Expression Level", "": "" }, { "Text": "Bulk RNA level", "": "" }, { "Text": "Bulk protein level", "": "" }, { "Text": "Durability", "": "" }, { "Text": "Tissue De-targeting (including liver and DRG)", "": "" }, { "Text": "Benchmarked vector genome residence", "": "" }, { "Text": "DNA MOI", "": "" }, { "Text": "Bulk RNA level", "": "" }, { "Text": "Bulk protein level", "": "" }, { "Text": "Projected Human Dose", "": "" }, { "Text": "Immunogenicity of capsid", "": "" }, { "Text": "Immunogenicity of cargo", "": "" }, { "Text": "Toxicity", "": "" }, { "Text": "Histopathology", "": "" }, { "Text": "Estimated Therapeutic Window (single dose)", "": "" }, { "Text": "Estimated Therapeutic Window (multi dose)", "": "" }, { "Text": "Manufacturing", "": "" }, { "Text": "Packaging efficiency", "": "" }, { "Text": "Immunogenicity", "": "" }, { "Text": "Immunogenicity of capsid", "": "" }, { "Text": "Immunogenicity of cargo", "": "" }, { "Text": "Neutralization by human patient serum", "": "" }, { "Text": "IP", "": "" }, { "Text": "Patentability/FTO assessment", "": "" }, { "Text": "Table 7. TDP43 CARGO Materials to be Transferred from AbbVie to Capsida", "": "" }, { "Text": "Table 7: TDP43 CARGO Materials to be Transferred from AbbVie to Capsida", "": "" }, { "Text": "Item Description Comments", "": "" }, { "Text": "Cargo – TDP43 (i) Sequence for tool-anti-TDP-43 cargo", "": "" }, { "Text": "(ii) Sequence for final anti-TDP-43 cargo", "": "" }, { "Text": "Tool cargo est 4Q2021", "": "" }, { "Text": "Final cargo est 4Q2022", "": "" }, { "Text": "Table 8. CAPSIDS AND RESEARCH PRODUCT MATERIALS: TDP43 PROGRAM", "": "" }, { "Text": "Table 8: CAPSIDS AND RESEARCH PRODUCT MATERIALS: TDP43 PROGRAM", "": "" }, { "Text": "Item Description Comments", "": "" }, { "Text": "Reserved Capsids _____", "": "" }, { "Text": "_____", "": "" }, { "Text": "_____", "": "" }, { "Text": "_____", "": "" }, { "Text": "as available", "": "" }, { "Text": "Selected Capsids (Primary Capsids and Backup Capsids) _____", "": "" }, { "Text": "_____", "": "" }, { "Text": "_____", "": "" }, { "Text": "as available", "": "" }, { "Text": "Research Product candidates (with cargo, including rodent versions) _____", "": "" }, { "Text": "_____", "": "" }, { "Text": "_____", "": "" }, { "Text": "_____", "": "" }, { "Text": "as available", "": "" }, { "Text": "Research Product", "": "" }, { "Text": "Exhibit C", "": "" }, { "Text": "POC Plan", "": "" }, { "Text": "1.0 Background", "": "" }, { "Text": "AbbVie and Capsida are collaborating on research activities aimed at identifying and optimizing capsids using the Capsida platform to deliver the AbbVie Cargo (\"cargo\") to cells in the central nervous system and / or spinal cord.", "": "" }, { "Text": "Capsida will harness its biologically driven, high-throughput non-human primate (NHP) screening platform and adeno-associated virus (AAV) engineering know-how to develop and validate novel AAVs with increased cargo expression and specificity for CNS cells (e.g., cortical neurons, dopaminergic neurons, oligodendrocytes) in the CNS compared with currently available capsids such as AAV9. Combined with AbbVie's differentiated clearance approach for tau, α-synuclein, and TDP43, the two organizations will collaborate to create innovative gene therapies for debilitating neurodegenerative disorders.", "": "" }, { "Text": "2.0 POC Plan Scope and Framework", "": "" }, { "Text": "The POC Plan will be focused on the IND-enabling work and First in Human / Proof-of-Concept (FIH / POC) clinical study for the TDP43 target (Figure 3). Capsida will be responsible for all activities within such plan as described in this document.", "": "" }, { "Text": "Figure 3: POC Plan (TDP43 Licensed Product)", "": "" }, { "Text": "Figure 3: POC Plan (TDP43 Licensed Product)", "": "" }, { "Text": "3.0 Preclincal / IND Enabling Studies", "": "" }, { "Text": "3.1 Additional Preclincal Pharmacology & Biomarker Studies with TDP43", "": "" }, { "Text": "Any additional preclinical efficacy/biomarker studies beyond what was conducted during the Collaboration Program Research Plan would be conducted at this stage. Although it will be the subject of a future FDA INTERACT meeting, below is a preliminary study design of a potential pharmacology study in rodents.", "": "" }, { "Text": "Group Dose Level Number of Animals", "": "" }, { "Text": "WT + High Dose TBD 15 male", "": "" }, { "Text": "15 female", "": "" }, { "Text": "WT + vehicle 0 15 male", "": "" }, { "Text": "15 female", "": "" }, { "Text": "Disease + vehicle 0 15 male", "": "" }, { "Text": "15 female", "": "" }, { "Text": "Disease + Low Dose TBD 15 male", "": "" }, { "Text": "15 female", "": "" }, { "Text": "Disease + Med Dose TBD 15 male", "": "" }, { "Text": "15 female", "": "" }, { "Text": "Disease + High Dose TBD 15 male", "": "" }, { "Text": "15 female", "": "" }, { "Text": "▪ Doses will be chosen based of previous mouse PK/PD work and expected target engagement.", "": "" }, { "Text": "▪ Based on the data from the Collaboration Program Research Plan efforts (see Exhibit B), the Working Group would decide what additional pharmacological studies, if any, may be required and appropriate for further characterization of the Research Product. This additional work may be conducted in parallel with IND enabling studies.", "": "" }, { "Text": "o Capsid choice made after assessment of novel variant biodistribution in rodents. Options include: 1) novel capsid delivered IV (if profile matches that of NHPs), 2) novel capsid delivered through alternate route that achieves relevant biodistribution to assess disease pathology, 3) rodent surrogate capsid matching relevant biodistribution to NHPs", "": "" }, { "Text": "▪ Expected study duration = To be determined (TBD) based on dose-efficacy relationship in mice studies and choice of disease model (e.g., for rNLS8 model = 16 weeks, with dox removed at 5 weeks of age and timing of AAV administration TBD by previous studies).", "": "" }, { "Text": "▪ Biodistribution of capsid and TDP43-cargo transgene evaluated in all relevant tissues.", "": "" }, { "Text": "▪ TDP43 pathology and neuroinflammation assessed across target CNS regions as relevant in chosen disease model.", "": "" }, { "Text": "▪ Survival time, body weight, and disease behavior phenotypes assessed as relevant in chosen disease model.", "": "" }, { "Text": "▪ Compound muscle action potentials assessed as relevant in chosen disease model.", "": "" }, { "Text": "▪ Target engagement biomarker assessed.", "": "" }, { "Text": "3.2 IND Enabling GLP Toxicology Studies (Licensed Product)", "": "" }, { "Text": "Although it will be the subject of a future FDA pre-IND meeting, below is a preliminary study design of the planned GLP toxicology study in NHPs.", "": "" }, { "Text": "Group Assignment and Dose Level", "": "" }, { "Text": "Group", "": "" }, { "Text": "Dose Level Dose Concentration No. of Animals", "": "" }, { "Text": "(VG/kg) (VG/mL)", "": "" }, { "Text": "3-Months", "": "" }, { "Text": "(Main)", "": "" }, { "Text": "6-Months", "": "" }, { "Text": "(Recovery/Persistence)", "": "" }, { "Text": "1 (Control) + IS 0 0 6 (3/sex) 6 (3/sex)", "": "" }, { "Text": "2 (low) + IS TBD TBD 6 (3/sex) 6 (3/sex)", "": "" }, { "Text": "3 (mid) + IS TBD TBD 6 (3/sex) 6 (3/sex)", "": "" }, { "Text": "4 (high) + IS TBD TBD 6 (3/sex) 6 (3/sex)", "": "" }, { "Text": "Key study design elements and endpoints", "": "" }, { "Text": "▪ 3 males and 3 females per group per timepoint will be given a single dose of TDP43 cargo - capsid via 15-minute IV infusion", "": "" }, { "Text": "▪ Biodistribution of Capsid and TDP43cargo transgene will be evaluated in tissues (including DRGs) and blood", "": "" }, { "Text": "▪ IFN-y ELISPOT or equivalent against TDP43 cargo and Capsid peptide pool", "": "" }, { "Text": "▪ TDP43 cargo (transgene) and capsid Ab ELISA from serum", "": "" }, { "Text": "▪ Capsid nAb titers from serum", "": "" }, { "Text": "▪ Vector shedding in urine, feces, and saliva via qPCR", "": "" }, { "Text": "▪ Clinical pathology", "": "" }, { "Text": "▪ Full tissue histopathology (including DRGs)", "": "" }, { "Text": "3.3 IND Data Package", "": "" }, { "Text": "The IND data package for the TDP43 program will be designed in accordance with 21 CFR Part 312, Investigational New Drug Application. The package will also consider FDA and international guidance on development of gene therapy products, as well as advice provided at planned FDA Interact and pre-IND meetings. In addition, the level of detail, particularly as it relates to authoring of the Investigator Brochure, will consider preferences of ex-US regions that might ultimately be included in the expansion phase of early clinical trial(s).", "": "" }, { "Text": "4.0 ALS POC", "": "" }, { "Text": "4.1 Clinical Development Plan", "": "" }, { "Text": "4.1.1 Study Design and Assumptions (high-level)", "": "" }, { "Text": "▪ Population: >18 years of age; weakness attributed to ALS; forced vital capacity (FVC) ≥ 50% of predicted value; consider El Escorial criteria", "": "" }, { "Text": "▪ Single dose, randomized, double-blinded, placebo-controlled study", "": "" }, { "Text": "▪ 2 dose levels: cohort 1 (n=10; 6 active); cohort 2 (n=16; 10 active)", "": "" }, { "Text": "▪ 6-month biomarker interim analysis; 18-24 months follow-up for efficacy and disease modification determination. Based on regulatory guidance, a 5-year follow-up for long term safety and tolerability is needed", "": "" }, { "Text": "▪ Primary endpoint: safety and tolerability", "": "" }, { "Text": "▪ Secondary endpoints: ALS Functional Rating Scale-Revised (ALSFRS-R) scores, percent predicted slow vital capacity (SVC), hand-held dynamometry (HHD) megascore (ie, quantitative muscle strength testing), CSF phosphorylated neurofilament heavy chain (pNFH)", "": "" }, { "Text": "▪ If identified, a target engagement biomarker will be included (e.g, measurement of TDP43 oligomer)", "": "" }, { "Text": "4.1.2 TDP43 Human POC Study Data Package: Reports & Deliverables", "": "" }, { "Text": "Clinical Study Report: This section highlights details of data and results to be included in the Clinical Study Report(s) after completion of the ALS POC plan.", "": "" }, { "Text": "Clinical data sets to include:", "": "" }, { "Text": "o Safety and tolerability data sets", "": "" }, { "Text": "o PK data sets", "": "" }, { "Text": "o Rating Scale results", "": "" }, { "Text": "o Pharmacodynamic measures including target engagement / biomarker expression levels in CSF / plasma (e.g., pNFH etc.)", "": "" }, { "Text": "Clinical Data Reporting: Reporting will include the following (to the extent applicable)", "": "" }, { "Text": "Data sets to include the following:", "": "" }, { "Text": "o Development Safety Update Reports", "": "" }, { "Text": "o Annual blinded / unblinded efficacy", "": "" }, { "Text": "o Clinical Study Report (CSR) for completed studies", "": "" }, { "Text": "Specifically, table(s) of key clinical data to be provided, to the extent applicable, (in a MS Word or pdf format of SAS outputs) that includes summary table and patient level data (data listings) for:", "": "" }, { "Text": "▪ Patient demographics, baseline characteristics and patient dispositions", "": "" }, { "Text": "▪ Endpoints / efficacy parameters measured", "": "" }, { "Text": "▪ Safety data including SAEs, AEs, fatal adverse events & discontinuations due to AEs", "": "" }, { "Text": "▪ Laboratory analysis and vital signs", "": "" }, { "Text": "▪ PK, PD and /or distribution measures", "": "" }, { "Text": "▪ Biomarkers and imaging, where applicable", "": "" }, { "Text": "▪ Any other relevant dataset and methodologies to enable analysis, interpretation of clinical datasets", "": "" }, { "Text": "4.1.3 Quality Assurance Considerations", "": "" }, { "Text": "Documentations from Capsida (and chosen CROs as applicable) to demonstrate that all studies are conducted in compliance with protocol, Good Clinical Practice and all other applicable regulatory requirements including the archiving of essential documents. This will include required maintenance of quality-control systems with written standard operating procedures to ensure the study was conducted and data were generated, documents and reported in compliance with protocol, GCP, and applicable regulatory requirements.", "": "" }, { "Text": "5.0 Manufacturing and Supply", "": "" }, { "Text": "Manufacturing activities to support IND-enabling studies and POC studies will be conducted by Capsida. This includes packaging and distribution.", "": "" }, { "Text": "6.0 Budget (PoC Plan)", "": "" }, { "Text": "POC Plan (TDP43 Only)", "": "" }, { "Text": "Description Tot. Patient Drug Placebo Cost Per Pat. Total Cost $M", "": "" }, { "Text": "Cohort 1 10 6 4 250,000 2.50", "": "" }, { "Text": "Cohort 2 16 10 6 250,000 4.00", "": "" }, { "Text": "5-year long term follow up 26 16 10 150,000 3.90", "": "" }, { "Text": 10.4, "": "" }, { "Text": "Per Year # of Years $ millions", "": "" }, { "Text": "Clinical Trial Costs (Site, Patient costs and Monitoring) 10.4", "": "" }, { "Text": "IND Enabling GLP Tox in NHPs 2.8", "": "" }, { "Text": "IND Enabling Mouse Pharmacology 0.8", "": "" }, { "Text": "All Manufacturing Production, Packaging, Distribution and Stability 7.5", "": "" }, { "Text": "Direct FTE Costs (primarily clin/reg with R&D supporting IND) 1.5 3 4.5", "": "" }, { "Text": "Indirect FTE Related Costs and Overhead 0.8 3 2.4", "": "" }, { "Text": "Contingency 1.6", "": "" }, { "Text": "GRAND TOTAL 30.0", "": "" }, { "Text": "10% of Grand Total 3.0", "": "" }, { "Text": "Exhibit D", "": "" }, { "Text": "Ophthalmology Research Plan", "": "" }, { "Text": "AbbVie Capsida Ophthalmology Collaboration Background and Capsid Program Research Plan1", "": "" }, { "Text": "Collaboration Background", "": "" }, { "Text": "AbbVie and Capsida are collaborating on research activities aimed at identifying and optimizing capsids using the Capsida Platform to deliver AbbVie Ophthalmology Cargo to cells in and around the eye as appropriate based on the Ophthalmology Target Capsid Profile (TCP).", "": "" }, { "Text": "Capsida will harness its biologically driven, high-throughput non-human primate (NHP) screening platform to develop and validate novel IVT, SCS, and IC delivered AAV capsids enabling increased cargo expression and optimal targeting for ocular tissues and cells directed towards the TCP (Table 1) compared with wild type serotypes such as AAV2 or AAV8. These capsids will be combined with AbbVie cargo for up to 3 targets to be selected as set forth in the Collaboration Agreement.", "": "" }, { "Text": "The activities in this Research Plan focus on the development and engineering of capsids directed towards TCPs provided in Table 1. Each of IVT, SCS and IC as described in Table 1 are distinct ROAs. Combined with AbbVie's differentiated capabilities in the ophthalmology space, the two organizations will collaborate to create innovative gene therapies for large population ophthalmic indications with high unmet need.", "": "" }, { "Text": "Table 1: Preliminary Target Capsid Profiles for de novo Eye Care Capsid Selection*", "": "" }, { "Text": "Attributes IVT Retina SCS Retina IC Anterior", "": "" }, { "Text": "Route of Administration", "": "" }, { "Text": "Distribution", "": "" }, { "Text": "Transduction Efficiency (average across gradient in distribution area)", "": "" }, { "Text": "Specificity / Tropism", "": "" }, { "Text": "Manufacturability", "": "" }, { "Text": "Volumetric requirements (max) @ titer 1013 vg/ml:", "": "" }, { "Text": "50 µl IVT; 100 µl SCS; 20 µl IC", "": "" }, { "Text": "* Target capsid profiles are subject to change based on recommendations by the Research Working Group and approval by JGC", "": "" }, { "Text": "1 Research Plan or \"research plan\" refers to this document as it may be amended by the JGC in accordance with the Collaboration Agreement.", "": "" }, { "Text": "Research Plan Scope and Framework", "": "" }, { "Text": "This Research Plan outlines activities and estimated timelines to be conducted by Capsida or AbbVie, as specified below. These activities are designed to generate and optimize capsids using the Capsida Platform to deliver AbbVie Cargo to the relevant ocular cells as described by the TCPs for this Research Plan. The TCP may be subject to change and will be further informed and refined based on preclinical disease biology and as data are generated in the course of the collaboration or based on scientific advances in the field.", "": "" }, { "Text": "Changes to the TCP must be approved by the Joint Governance Committee (JGC) in accordance with the Agreement. It is expected that the JGC will discuss, review, and approve amendments to this Research Plan on a periodic basis based on scientific data, developments in the field, or other matters that may arise, in each case as set forth in the Agreement. The JGC will also monitor workflow, resource allocation, timelines, and overall progress under this Research Plan.", "": "" }, { "Text": "Capsida plans to focus engineering efforts on AAV2 and AAV8, subject to reconsideration based on best available internal and external data and Research Working Group recommendation.", "": "" }, { "Text": "AbbVie target and cargo development will be ongoing throughout the duration of the Research Plan but with activities related thereto falling outside of the scope of this Research Plan. It is the parties' intent that all cargo optimization, including post-transcriptional regulatory elements (PREs), promoters, etc., will be the responsibility of AbbVie with consultation and research vector material supply in support of these efforts by Capsida. These activities will be discussed at the Research Working Group to ensure both parties are aware of such activities. AbbVie will provide tool cargo or final cargo for the candidate identification studies, based on discretion of Research Working Group.", "": "" }, { "Text": "High Level Roles and Responsibilities", "": "" }, { "Text": "Capsida activities", "": "" }, { "Text": "▪ Engineering strategy", "": "" }, { "Text": "▪ Proprietary cargo for Library Screening, Variant Optimization, and Final Variant Optimization", "": "" }, { "Text": "▪ Developing and optimizing methods for extraction of high quality and quantity nucleic acids from ocular tissue", "": "" }, { "Text": "▪ Evaluating cross-ocular transduction and safety/efficacy impact of dosing simultaneously with two wildtype serotypes and/or two or more ROAs.", "": "" }, { "Text": "▪ Evaluating different mutagenesis strategies (e.g., peptide insertion site) and screening constructs (e.g., utilizing different ubiquitous or ocular-specific promoters) on parental serotypes for impact on library manufacturability and quality", "": "" }, { "Text": "▪ Evaluating libraries (non-CNS) or capsids in rabbits or other species to evaluate potential of different engineering strategies and/or establish capsid benchmarks as described in the research plan", "": "" }, { "Text": "▪ Develop bioinformatic tools for quantifying viral transcripts and mapping them to particular cell types", "": "" }, { "Text": "▪ AAV2 capsid generation, screening and variant optimization in NHPs toward SCS TCP", "": "" }, { "Text": "▪ AAV2 capsid generation, screening and variant optimization in NHPs toward IVT TCP", "": "" }, { "Text": "▪ AAV2 capsid generation, screening and variant optimization in NHPs toward IC TCP", "": "" }, { "Text": "▪ AAV8 capsid generation, screening and variant optimization in NHPs toward SCS TCP", "": "" }, { "Text": "▪ AAV8 capsid generation, screening and variant optimization in NHPs toward IVT TCP", "": "" }, { "Text": "▪ AAV8 capsid generation, screening and variant optimization in NHPs toward IC TCP", "": "" }, { "Text": "▪ FTO screening prior to or in parallel with Secondary and Final Pooled Candidate Identification Studies", "": "" }, { "Text": "▪ HEK adherent vector production of novel AAV2 capsids and QC testing", "": "" }, { "Text": "▪ HEK adherent vector production of novel AAV8 capsids and QC testing", "": "" }, { "Text": "▪ Study design for Pooled Candidate Identification Studies", "": "" }, { "Text": "o AAV2 engineered capsids delivered by SCS", "": "" }, { "Text": "o AAV2 engineered capsids delivered by IVT", "": "" }, { "Text": "o AAV2 engineered capsids delivered by IC", "": "" }, { "Text": "o AAV8 engineered capsids delivered by SCS", "": "" }, { "Text": "o AAV8 engineered capsids delivered by IVT", "": "" }, { "Text": "o AAV8 engineered capsids delivered by IC", "": "" }, { "Text": "▪ Study design for Single Variant Characterization Studies", "": "" }, { "Text": "▪ Benchmarked vector genome residence in NHPs, rodents, and/or rabbits as described in the research plan", "": "" }, { "Text": "▪ Biodistribution analysis in NHPs, rodents, and/or rabbits as described in the research plan", "": "" }, { "Text": "▪ In vitro and ex vivo immunogenicity assays and assay development for NHPs as specified in the research plan", "": "" }, { "Text": "▪ Capsid quality attributes assessment for capsids in pooled candidate identification and single variant studies", "": "" }, { "Text": "▪ Packaging efficiency and stability testing (i.e., measuring aggregation and titer after 3x freeze/thaw rounds) for capsids in single variant studies", "": "" }, { "Text": "▪ Provide AbbVie with NHP-identified reserve capsids following each candidate identification study to validate in preclinical models; with preference towards capsids that are translatable across species", "": "" }, { "Text": "▪ Single-cell RNA sequencing as appropriate", "": "" }, { "Text": "AbbVie activities", "": "" }, { "Text": "▪ Non-proprietary tool cargo (GFP) for platform build activities provided to Capsida", "": "" }, { "Text": "▪ Representative cargo (plasmid and sequence) for first pooled candidate identification study provided by at least four months prior to initiation of study", "": "" }, { "Text": "▪ Optimized therapeutic cargo for single variant study, if ready, provided by at least two months prior to initiation of study; otherwise, representative cargo will be used.", "": "" }, { "Text": "▪ All in-life activities including but not limited to:", "": "" }, { "Text": "o IVT, SCS, and IC dosing", "": "" }, { "Text": "o Ophthalmic evaluations for tolerability / inflammation", "": "" }, { "Text": "o Cross-species screening, including rodent, rabbit, and NHP", "": "" }, { "Text": "o Ocular tissue dissection and pre-processing", "": "" }, { "Text": "o Animal housing, welfare and care", "": "" }, { "Text": "▪ Methods for scRNAseq sample prep on ocular samples", "": "" }, { "Text": "▪ Evaluation of protein expression as agreed upon", "": "" }, { "Text": "▪ Clinical pathology as described in research plan", "": "" }, { "Text": "▪ Histopathology as described in research plan", "": "" }, { "Text": "▪ Ex vivo immunogenicity assays conducted on aqueous humor samples as described in research plan", "": "" }, { "Text": "▪ In silico T cell prediction as described in research plan", "": "" }, { "Text": "▪ In vitro capsid assay for RNA and protein expression (as described in the research plan)", "": "" }, { "Text": "▪ Ocular tolerability/safety as described in the research plan", "": "" }, { "Text": "▪ Testing on reserved capsids with test cargo to determine certain factors, including distribution, specificity, and percentage of cells transduced as well as expression of test cargo", "": "" }, { "Text": "▪ Validation of primate capsids in preclinical animal models", "": "" }, { "Text": "AbbVie is responsible for making decisions related to animal welfare (e.g. early euthanasia due to animal welfare concerns). When possible, AbbVie will discuss these decisions with Capsida in advance, but for clarity, animal welfare will take priority and such decisions may require prompt action without advance notice to Capsida.", "": "" }, { "Text": "AbbVie does not anticipate using CROs for animal studies and can fully support in-house. Should AbbVie contemplate the need to engage with a CRO, AbbVie will discuss its decision with the Research Working Group.", "": "" }, { "Text": "Figure 1: High Level Timeline of Capsid Development Activities", "": "" }, { "Text": "Serotype/ROA screening will inform ROA (e.g., IC administration), serotype, or other focus of the 3rd research plan workstream.", "": "" }, { "Text": "*The baseline assumption is that IVT injections may be used as surrogate route in some instances for selecting capsids intended for the IC->anterior route, but this will only be done in consultation with, and with the approval of, the JGC. The rationale for this is that there are no major anatomic barriers between the vitreous and anterior chamber and utilizing an IVT route at some stages may reduce the use of non-human primates and other resources without impacting the results; however, any decision to consolidate IC RoA methods will be made by JGC. The RWG will continue to evaluate the use of IVT vs. IC in this context based on current data and recommend to the JGC at which steps IVT or IC route will be utilized towards the goal of identifying optimized capsids for the IC -> anterior route of administration.", "": "" }, { "Text": "** Current timelines assume engineered capsids for SCS route of administration will progress to a Final Pooled Candidate Identification Study after Variant Optimization, subject to RWG decision. Alternatively, the RWG may opt to progress to Final Variant Optimization and Secondary Pooled Candidate Identification Study after Variant Optimization.", "": "" }, { "Text": "**Current timelines assume 1 week turnaround time for ocular tissue dissection and pre-processing by AbbVie, non-proprietary tool cargo (GFP) for platform build activities provided to Capsida by AbbVie within one month of signing, and tissues for developing and optimizing methods for extraction of high quality and quantity nucleic acids from ocular tissue to be provided by AbbVie within two months of signing.", "": "" }, { "Text": "Figure 2: High Level Timeline of Roles / Responsibilities:", "": "" }, { "Text": "Description of Program Activities", "": "" }, { "Text": "I. Build and Platform Development", "": "" }, { "Text": "Preliminary activities will focus on method validation, process optimization, non-NHP screening and method development prior to NHP screening. Activities include:", "": "" }, { "Text": "1. Developing and optimizing methods for extraction of high quality and quantity nucleic acids from ocular tissue (AbbVie to provide existing tissues for rabbit and/or rodent in the form agreed by the RWG.", "": "" }, { "Text": "a. Rationale: Capsida has found different tissues to have different nucleic acid yields and processing requirements; method development with our automated systems will be required for ocular tissues specific to different punch regions or microdissections", "": "" }, { "Text": "2. Dosing rabbits simultaneously with two wildtype serotypes (and potentially novel capsids from bullet #4) and/or two or more ROAs (dose alternate eyes) to evaluate cross-ocular transduction and safety/efficacy impact (AbbVie providing in-life and ocular tissue dissection at the time in the form agreed by the RWG)", "": "" }, { "Text": "a. Rationale: Establishing feasibility of multi-serotype or multi-ROA screening can halve the number of primates necessary for this collaboration", "": "" }, { "Text": "3. Evaluating different mutagenesis strategies (e.g., peptide insertion site) and screening constructs (e.g., utilizing different ubiquitous or ocular-specific promoters) on parental serotypes for impact on library manufacturability and quality (AbbVie to supply plasmids encoding test genome including, promoters, expression elements at the time and in the form agreed by the RWG)", "": "" }, { "Text": "a. Rationale: Capsida has found different peptide insertion sites and cargo constructs can have significant impact on vector productivity on a serotype-specific basis, requiring evaluation of multiple serotypes novel to Capsida (AAV8, AAV5) for establishing optimal library strategy", "": "" }, { "Text": "4. Dosing rabbits with exploratory libraries (non-CNS) or capsids to evaluate potential of different engineering strategies and/or establish capsid benchmarks (Similar to bullet #2) (AbbVie providing in-life and ocular tissue dissection at the time and in the form agreed by the RWG)", "": "" }, { "Text": "a. Rationale: Transduction baselines for wild-type and engineered serotypes into ocular tissue is significantly different than for CNS tissues; we would like to optimize our library screening approach (e.g. cycles of PCR, input nucleic acid concentration) prior to NHP studies", "": "" }, { "Text": "5. Process tissues from above study(ies) with Capsida's scRNAseq method, evaluate existing AbbVie scRNAseq data, and use this to develop bioinformatic tools for quantifying viral transcripts and mapping them to particular cell types (AbbVie provide tissue & data at the time and in the form agreed by the RWG)", "": "" }, { "Text": "a. Rationale: Development of custom bioinformatic tools for mapping viral transcripts to cell types, particularly in a novel space like ocular tissues, is nontrivial. Expediting this method development provides upside of incorporating scRNAseq earlier in the engineering process", "": "" }, { "Text": "II. Initial Library Screening (Round 1 and Round 2) – IVT and SCS", "": "" }, { "Text": "All library screening will be conducted in NHPs. Initial library screening efforts (i.e., de novo) begin with peptide substitutions and / or insertions into capsid variants based on (1) AAV2 and (2) AAV8 serotypes with Capsida proprietary cargo delivered via (1) IVT and (2) SCS (and possibly (3) IC) administration. It may be possible to dose different ROAs in right and left eyes of the same animal. At this stage it is anticipated that IVT administration can also be used for selection of the IC route of administration TCP at this and perhaps other stages. Recommendation from the RWG at this and each subsequent stage will be based on currently available data. As part of the proposed collaboration, Capsida would optimize engineering and screening efforts for the proposed target capsid profiles, including in vivo and in vitro data. Library screening in NHPs (n=3) will encompass two rounds. AbbVie will also screen capsids in rodents (n=3-10) and rabbits (n=3-10); continued screening in these animals will be further evaluated and refined by the Research Working Group (RWG). Animals will be dosed at the AbbVie facility, with vector (packaged virus) provided by Capsida (ideally within 2 days since vector production). AbbVie and Capsida will coordinate on a rapid and compliant method of transport of materials between Capsida and AbbVie facilities. NHP in-life to be 3-6 weeks (anticipating 3 weeks for Round 1 and 4 weeks for Round 2). The studies will assess benchmarked vector genome residence and biodistribution. AbbVie will establish methods for SCS injection in rats; other injection methods/species combinations have been previously established at AbbVie.", "": "" }, { "Text": "AbbVie will perform routine gross ophthalmic and animal welfare evaluations throughout the in-life portion of the studies. More detailed methods of ophthalmic evaluation, including slit lamp biomicroscopy, indirect ophthalmoscopy, color fundus imaging, optical coherence tomography, as well as aqueous or vitreous inflammation biomarker and/or histopathology analysis will be performed as described in the research plan (e.g. to evaluate suspected inflammation or for studies where tolerability/inflammation is being specifically evaluated).", "": "" }, { "Text": "Capsida will be responsible for engineering strategy, virus library generation, vector production and QC, benchmarked vector genome residence, and analysis of DNA biodistribution in the tissues. AbbVie will be responsible for in-life activities including IVT and SCS administration, and ocular tissue dissection and pre-processing. Ocular tissue dissection and pre-processing will be provided in a form agreed upon by the RWG. Data package elements are described in Table 2.", "": "" }, { "Text": "Based upon the data package from Initial Library Screening, the RWG will recommend to the Joint Governance Committee (JGC) moving to First Pooled Candidate Identification studies or continued library screening. AbbVie can select up to 5 Reserved Capsids per route of administration (IVT, SCS, and IC) from this initial screening effort.", "": "" }, { "Text": "III. First Pooled Candidate Identification Studies – IVT, SCS and IC as agreed by the JGC", "": "" }, { "Text": "JGC will agree on the top performing capsid variants from AAV2 and AAV8 backbones as well as relevant control capsids from the engineering platform that will be tested in Pooled Candidate Identification studies with a tagged cargo that is representative of the final cargo (either the final cargo or a surrogate/lead). Unless otherwise agreed by the JGC six First Pooled Candidate Identification studies will be conducted subject to the outcome of data analysis, as further described in this paragraph: AAV2 engineered capsids delivered by SCS, AAV2 engineered capsids delivered by IVT, AAV8 engineered capsids delivered by SCS, AAV8 engineered capsids delivered by IVT, AAV2 engineered capsids delivered by IC unless otherwise determined by the JGC, and AAV8 engineered capsids delivered by IC unless otherwise determined by the JGC. Decision to employ separate IC studies rather than using IVT delivery to anterior tissues will be driven by data in previous stages of the research plan and other relevant information and subject to determination by the JGC. Based on the results of prior activities, it may be possible to reduce the number of First Pooled Candidate Identification Studies by combining pools that evaluate more than 1 route of delivery in the same animal or both serotypes in one animal.", "": "" }, { "Text": "AbbVie and Capsida will screen capsids in rodents (n=3-10) and rabbits (n=3-10) (as agreed by the RWG); continued screening in these animals will be further evaluated and refined by the RWG. Animals will be dosed at AbbVie facility, with vector provided by Capsida. NHP (n=3) in-life to be 3-8 weeks.", "": "" }, { "Text": "Each First Pooled Candidate Identification Study will assess DNA biodistribution, benchmarked vector genome residence, single cell RNA expression as appropriate, gross transduction in target tissues, and capsid quality attributes. Teams to further clarify in vivo protein expression evaluation and assessment of in vitro mRNA and protein expression as part of RWG discussions. Clinical pathology, histopathology, and ex vivo immunogenicity assessments will be conducted as agreed by RWG and may be investigational in nature.", "": "" }, { "Text": "Capsida will be responsible for vector production and QC, benchmarked vector genome residence, analysis of DNA biodistribution in the tissues, and capsid quality attribute assessments. Capsida and AbbVie will be responsible for their respective activities related to the ex vivo immunogenicity assays if needed as described in Table 3 below. AbbVie will be responsible for in-life activities including IVT, SCS, and IC (when implemented) administration, and ocular tissue dissection and pre-processing. Ocular tissue dissection and pre-processing will be provided in a form agreed upon by the. AbbVie will assess in vivo protein expression when relevant (as agreed by the RWG) and evaluate in vitro mRNA and protein expression (as agreed by the RWG). AbbVie will assess clinical pathology and/or histopathology if needed in investigational nature as agreed by the RWG. Teams will collaborate on single cell RNA sequencing method development and analysis. Data package elements described in Table 3.", "": "" }, { "Text": "Based upon the data package from the candidate identification study, the RWG will recommend to the JGC moving to Variant Optimization or continued library screening. The RWG will evaluate if available data support that engineering efforts in variant optimization should be focused on a single serotype.", "": "" }, { "Text": "Following data readout from this study, AbbVie can select up to 5 Reserved Capsids per route of administration (IVT, SCS, and IC). For clarity, if IVT route is used at this stage as a surrogate for IC, Reserved Capsids for IC route of administration will be selected based on anterior distribution of IVT-delivered capsids.", "": "" }, { "Text": "IV. Variant Optimization (Round 1 and Round 2) – IVT and SCS (IC as agreed by the JGC)", "": "" }, { "Text": "Top performing capsids from the Pooled Candidate Identification Study, as determined by the JGC, will be moved into re-diversification and library screening in NHPs (n=3) aimed at increasing efficacy and/or specificity in ocular cells as relevant for the TCPs. Variant optimization will encompass two rounds. Capsids with Capsida proprietary cargo delivered via IVT and SCS (and IC as agreed by the JGC) administration will be evaluated in each round. Benchmark AAV2 and/or AAV8 serotypes may be included dependent on RWG recommendation and JGC determination. AbbVie will also screen capsids in rodents (n=3-10) and rabbits (n=3-10); continued screening in these animals will be further refined by the RWG. Animals will be dosed at AbbVie facility, with vector provided by Capsida (ideally within <=2 days since vector production). NHP in-life to be 3-6 weeks (anticipating 3 weeks for Round 1 and 4 weeks for Round 2).", "": "" }, { "Text": "Capsida will be responsible for engineering strategy, virus library generation, vector production and QC, benchmarked vector genome residence, analysis of DNA biodistribution in the tissues, and FTO search of capsids nominated for Secondary or Final Pooled Candidate Identification Study. FTO search may occur prior to or in parallel with aforementioned study. AbbVie will be responsible for in-life activities including IVT and SCS administration, and ocular tissue dissection and pre-processing. Ocular tissue dissection and pre-processing will be provided in a form agreed upon by the RWG and is estimated to take 1 week following in-life. Data package elements are described in Table 2.", "": "" }, { "Text": "Based upon the data package from Variant Optimization, the RWG will recommend to the JGC whether to progress to Secondary Pooled Candidate Identification studies, Final Pooled Candidate Identification Study, Final Variant Optimization, or continued library screening Currently, parties anticipate engineered capsids for SCS route of administration may progress to a Final Pooled Candidate Identification Study after Variant Optimization, subject to RWG review of available data. Alternatively, the RWG may opt to progress in parallel to Final Variant Optimization and Secondary Pooled Candidate Identification Study following Variant Optimization. Engineered capsids from IVT route of administration will progress in parallel to Final Variant Optimization and Secondary Pooled Candidate Identification studies following Variant Optimization (see Figure 1). Decision whether or not to include IC administration in the Secondary or Final Pooled Candidate Identification Study will be made as discussed in sections V and VII.", "": "" }, { "Text": "Following data readout from this study, AbbVie can select up to 5 Reserved Capsids per route of administration (IVT, SCS, and IC). For clarity, if IVT route is used at this stage as a surrogate for IC, Reserved Capsids for IC route of administration will be selected based on anterior distribution of IVT-delivered capsids.", "": "" }, { "Text": "V. Secondary Pooled Candidate Identification Studies – SCS, IVT, and/or IC as agreed by the JGC", "": "" }, { "Text": "JGC will agree on top performing capsid variants identified from Variant Optimization (and potentially Initial Library Screening) that will be tested in a Pooled Candidate Identification study with a tagged cargo that is representative of the final cargo (either the final cargo or a surrogate/lead). Unless otherwise agreed by the JGC six Pooled Candidate Identification studies are anticipated to be conducted, subject to the outcome of data analysis, as further described below: AAV2 engineered capsids delivered by SCS, AAV2 engineered capsids delivered by IVT, AAV8 engineered capsids delivered by SCS, AAV8 engineered capsids delivered by IVT, AAV2 engineered capsids delivered by ICunless otherwise determined by the JGC, and AAV8 engineered capsids delivered by ICunless otherwise determined by the JGC. Decision whether or not to employ separate IC studies rather than using IVT delivery to anterior tissues will be driven by data in previous stages of the research plan and other relevant information and subject to agreement by the JGC. Based on the results of prior studies, it may be possible to reduce the number of Secondary Pooled Candidate Identification Studies, by combining pools that evaluate more than 1 route of delivery in the same animal or both serotypes in one animal as determined by the JGC.", "": "" }, { "Text": "AbbVie and Capsida will screen capsids in rodents (n=3) and rabbits (n=3); continued screening in these animals will be further refined by RWG. Animals will be dosed at AbbVie facility, with vector provided by Capsida. NHP (n=3) in-life to be 3-8 weeks.", "": "" }, { "Text": "Each study will assess DNA biodistribution, benchmarked vector genome residence, single cell RNA expression as appropriate, gross transduction in target tissues, and capsid quality attributes. Teams to further clarify in vivo protein expression evaluation and assessment of in vitro mRNA and protein expression as part of RWG discussions. Clinical pathology, histopathology, and ex vivo immunogenicity assessments will be conducted if needed and may be investigational in nature.", "": "" }, { "Text": "Capsida will be responsible for vector production and QC, benchmarked vector genome residence, analysis of DNA biodistribution in the tissues, and capsid quality attribute assessments. Capsida and AbbVie will be responsible for their respective activities related to the ex vivo immunogenicity assays if needed as described in Table 3 below. AbbVie will be responsible for in-life activities including IVT and IC (IC administration unless otherwise determined by the JGC) administration, and ocular tissue dissection and pre-processing. Ocular tissue dissection and pre-processing will be provided in a form agreed upon by the RWG and is estimated to take 1 week following in-life. AbbVie will assess in vivo protein expression when relevant (as agreed by the RWG) and in vitro mRNA and protein expression (as agreed by the RWG). AbbVie will assess clinical pathology, and histopathology if needed in investigational nature as agreed by the RWG). Teams will collaborate on single cell RNA sequencing method development and analysis. Data package elements are described in Table 3.", "": "" }, { "Text": "Based on the data package for this study, the Research Working Group shall recommend to the JGC whether to continue the Variant Optimization Research Stage or to progress to the Final Variant Optimization Research Stage and which capsids to further optimize in the Final Variant Optimization Research Stage or to continue in the Variant Optimization Research Stage. Following data readout from this study, AbbVie can select up to 5 Reserved Capsids per route of administration (IVT, SCS, and IC). For clarity, if IVT route is used at this stage as a surrogate for IC, Reserved Capsids for IC route of administration will be selected based on anterior distribution of IVT-delivered capsids.", "": "" }, { "Text": "VI. Final Variant Optimization (Round 1 and Round 2) – IVT, SCS, and/or IC agreed by the JGC", "": "" }, { "Text": "Depending on RWG recommendation and JGC determination, top performing capsids with Capsida proprietary cargo delivered via IVT, SCS, and IC administration (unless otherwise agreed by the JGC) will each undergo two additional rounds of variant optimization to increase efficacy and/or specificity toward TCP (unless the RWG determines that only one additional round is needed for a Route of Administration based on the results of the Secondary Pooled CI study for such Route of Administration). Current timelines assume that the first round of Final Variant Optimization will occur in parallel with Secondary Pooled Candidate Identification study. As currently contemplated, the second round of Final Variant Optimization will initiate shortly following the completion of the Secondary Pooled Candidate Identification study.", "": "" }, { "Text": "Dependent on prior activities, AAV2 and/or AAV8 engineered capsids may be included in this step. AbbVie will also screen capsids in rodents (n=3-10) and rabbits (n=3-10); continued screening in these animals will be further evaluated and refined by RWG. Animals will be dosed at AbbVie facility, with vector provided by Capsida (ideally within <2 days since vector production). NHP (n=3) in-life to be 3-6 weeks (anticipating 3 weeks for Round 1 and 4 weeks for Round 2).", "": "" }, { "Text": "Capsida will be responsible for engineering strategy, virus library generation, vector production and QC, benchmarked vector genome residence, analysis of DNA biodistribution in the tissues, and FTO search of capsids nominated for the Final Pooled Candidate Identification Study. FTO search may occur prior to or in parallel with aforementioned study. AbbVie will be responsible for in-life activities including IVT and SCS administration, and ocular tissue dissection and pre-processing. Ocular tissue dissection and pre-processing will be provided in a form agreed upon by the RWG. Data package elements are described in Table 2.", "": "" }, { "Text": "Capsida anticipates that top performing capsids from Final Variant Optimization could be sufficiently optimized to move into a third Pooled Candidate Identification study. Decision to move to the Final Pooled Candidate Identification study will be based on available data. The RWG will recommend to JGC whether to move to the Final Pooled Candidate Identification study or continue Final Variant Optimization on a route of administration-by-route of administration basis.", "": "" }, { "Text": "Following data readout from this study, AbbVie can select up to 5 Reserved Capsids per route of administration (IVT, SCS, and IC). For clarity, if IVT route is used at this stage as a surrogate for IC, Reserved Capsids for IC route of administration will be selected based on anterior distribution of IVT-delivered capsids.", "": "" }, { "Text": "VII. Final Pooled Candidate Identification Studies – IVT, SCS, and/or IC as agreed by the JGC", "": "" }, { "Text": "JGC will agree on the top performing capsid variants from Final Variant Optimization (and potentially earlier rounds) delivered via IVT administration which will be tested in a Final Pooled Candidate Identification Study with a tagged cargo that is representative of the final cargo (either the final cargo or a surrogate/lead). The number of Pooled Candidate identification studies will depend upon the routes of administration used, as well as the number of libraries tested. It may be possible to reduce the number of Final Pooled Candidate Identification Studies, by combining pools that evaluate more than 1 route of delivery in the same animal or both serotypes in one animal.", "": "" }, { "Text": "AbbVie and Capsida will screen capsids in rodents (n=3-10) and rabbits (n=3-10); continued screening in these animals will be further evaluated and refined by RWG. Animals will be dosed at AbbVie facility, with vector provided by Capsida. NHP (n=3) in-life to be 3-8 weeks.", "": "" }, { "Text": "Each study will assess DNA biodistribution, benchmarked vector genome residence, single cell RNA expression as appropriate, gross transduction in target tissues, capsid quality attributes, and ocular tolerability / safety as appropriate. Teams to further clarify in vivo protein expression evaluation and assessment of in vitro mRNA and protein expression as part of RWG discussions. Clinical pathology, histopathology, and ex vivo immunogenicity assays will be conducted if needed as agreed by RWG and may be investigational in nature. In vitro immunogenicity assays and in silico T cell epitope prediction on capsid candidates will be conducted in parallel with the in-life part of the study. In vitro and in silico immunogenicity risk assessment on individual capsids present in the pool will be performed by Capsida and AbbVie as described in Table 4.", "": "" }, { "Text": "Capsida will be responsible for vector production and QC, benchmarked vector genome residence, analysis of DNA biodistribution in the tissues, capsid quality attribute assessments, and in vitro immunogenicity assays. Capsida and AbbVie will be responsible for ex vivo immunogenicity assays if needed as described in Table 4. AbbVie will be responsible for in-life activities including IVT and IC (unless otherwise determined by the JGC) administration, and ocular tissue dissection and pre-processing. Ocular tissue dissection and pre-processing will be provided in a form agreed upon by the RWG. AbbVie will assess in vivo protein expression (as agreed by RWG) and in vitro mRNA and protein expression (as agreed by RWG). AbbVie will assess clinical pathology and histopathology if needed in investigational nature as agreed by the RWG. AbbVie will conduct ocular tolerability/safety as agreed by RWG when possible, with acknowledgement that there may be urgent situations in which AbbVie collects samples at their discretion. Teams will collaborate on single cell RNA sequencing method development and analysis. Data package elements are described in Table 4.", "": "" }, { "Text": "Following data readout from this study, AbbVie can select up to 5 Reserved Capsids per route of administration (IVT, SCS, and IC). For clarity, if IVT route is used at this stage as a surrogate for IC, Reserved Capsids for IC route of administration will be selected based on anterior distribution of IVT-delivered capsids.", "": "" }, { "Text": "VIII. Single Variant Characterization Studies – SCS, IVT, IC", "": "" }, { "Text": "A subset of reserve capsids will be evaluated in a Single Variant Characterization study delivered via SCS, IVT, and IC administration with a tagged cargo representative of the final cargo or optimized therapeutic cargo if available.", "": "" }, { "Text": "It may be possible to evaluate one capsid in each eye. The Single Variant Characterization Studies will have an objective to confirm properties of capsid candidates including but not limited to the tissue biodistribution, cell type specificity, transduction, duration of expression, and immunogenicity. In some cases these may also be used to establish a therapeutic index based on single- or multi-dose non-GLP safety/toxicology study of the optimized final Selected Ophthalmology Capsid(s) together with the selected AbbVie Ophthalmology Cargo.", "": "" }, { "Text": "Animals will be dosed at AbbVie facility, with vector provided by Capsida. This study will evaluate up to 5 engineered capsids and parental serotype(s) in NHPs, i.e., n=up to 18 per route of administration. In-life to be 3-8 weeks. RWG may decide to conduct Single Variant Characterization study in rodents and/or rabbits.", "": "" }, { "Text": "Data to be assessed include DNA biodistribution, single cell RNA expression in NHPs, transduction in target tissues in NHPs, ocular tolerability/safety, ex vivo immunogenicity assays, and clinical pathology in NHPs. Teams to further clarify in vivo protein expression evaluation as part of RWG discussions. Histopathology will be conducted as agreed by RWG. Concurrent with this study, Capsida will evaluate packaging efficiency and stability (measured as aggregation and titer following 3x rounds of freeze/ thaw) of the capsids selected for the Single Variant Characterization study.", "": "" }, { "Text": "Capsida will be responsible for vector production and QC, analysis of DNA biodistribution in the tissues, capsid quality attribute assessment, and packaging efficiency and stability assays. Capsida and AbbVie will be responsible for their respective activities related to the ex vivo immunogenicity assays as described in Table 5. AbbVie will be responsible for in-life activities including IVT, SCS and IC (unless otherwise determined by the JGC) administration, ocular tissue dissection and pre-processing, clinical pathology, and ocular tolerability/safety. Ocular tissue dissection and pre-processing will be provided in a form agreed upon by the RWG. AbbVie will assess in vivo protein expression and histopathology if needed. Teams will collaborate on single cell RNA sequencing method development and analysis. Data package elements, including packaging efficiency and stability assays, are described in Table 5.", "": "" }, { "Text": "Data generated by Single Variant Characterization Study on capsids delivered via SCS, IVT, and IC will inform AbbVie's determination of AbbVie Selected Ophthalmology Capsids.", "": "" }, { "Text": "IX. AbbVie Cargo and Expression Elements Improvement Activities", "": "" }, { "Text": "During the Research Plan, AbbVie may further improve the AbbVie Ophthalmology Cargo and Expression Elements as necessary. In support of these activities, Capsida will provide vector for these evaluations and expert opinion.", "": "" }, { "Text": "X. Vector Optimization", "": "" }, { "Text": "AbbVie may conduct preliminary assessment of the efficacy of various vector designs to inform the choice of cargo for the Single Variant Characterization Studies. AbbVie will transfer the AbbVie Cargo sequence to Capsida for research grade production with different gene regulatory elements. Packaged virus will be transferred back to AbbVie for disease model studies. Capsida will support vector optimization activities through consultation, supply, and characterization of vector. Characterization of vector will include activities as agreed upon by the RWG. AbbVie will conduct vector optimization activities that can include assessment of the efficacy of various expression elements, including promoter elements (e.g., ubiquitous and cell-type specific promoters), assessment for single stranded (ss) or self-complementary (sc) AAV packaging, codon optimization, removal of CpG islands, and other genome optimizations required to maintain or achieve Target Capsid Profile, etc.", "": "" }, { "Text": "XI. Process and Analytical Development, Scale-up and Supply", "": "" }, { "Text": "Capsida will provide non-GLP supply (research grade material) for discovery and preclinical research. Upon opt-in of AbbVie Selected Ophthalmology Capsids, Capsida will initiate process development activities shown below for up to a total of 3 programs (one per target, i.e. the lead) in support and as required to generate GLP-tox material that will satisfy the requirements of applicable regulations for such material. Any clinical material will be cGMP grade, and is subject to negotiation of a separate supply agreement.", "": "" }, { "Text": "The FDA guidelines for cellular and gene therapy products recommends multiple CMC-related activities to characterize product quality and manufacturing controls, to assure identity, purity, sterility and stability of products to certify lot release and establish product dating and shelf life. If Capsida is the site of manufacture for the clinical studies, it is contemplated that these activities would best be performed by Capsida, proximal to the site of manufacture.", "": "" }, { "Text": "AbbVie will take primary responsibility for developing the potency assay for quantifying the transducibility and efficacy of the protein produced from a specific lot of product. If Capsida produces material for clinical supply, AbbVie will transfer the assay and reagents to Capsida for validation. Other assays necessary for the supply of GLP-Tox Material, including capsid empty / full ratio, purity / contaminants, AAV aggregation, AAV titer, and infectivity will be developed and performed by Capsida in accordance with FDA guidance.", "": "" }, { "Text": "The cargo sequence will be transferred to the process development team and synthesized in a plasmid backbone suitable for manufacturing. Positive control material will be generated using the selected capsid and cargo to serve as a reference control for analytical development activities and evaluate process fit in each manufacturing process step. Upstream and downstream development will be implemented to improve productivity, process recovery, and ensure sufficient enrichment of full capsids to meet Target Product Profile. Following the completion of process and analytical development, production will occur at the 50L scale to meet material demands for GLP toxicology and other IND enabling studies required to support IND.", "": "" }, { "Text": "Table 2 - Data Package Elements - Library Screening and Variant Optimization (Round 1 and Round 2)*", "": "" }, { "Text": "Category Analysis Assay Results Responsible Party", "": "" }, { "Text": "NHP", "": "" }, { "Text": "Biodistribution -target tissues", "": "" }, { "Text": "Rodent", "": "" }, { "Text": "Biodistribution -target tissues", "": "" }, { "Text": "Rabbit", "": "" }, { "Text": "Biodistribution -target tissues", "": "" }, { "Text": "*RWG may augment to include single cell RNA sequencing and RNA analysis as appropriate. Single cell RNA sequencing requires additional method development.", "": "" }, { "Text": "Note, FTO search to be conducted prior to or in parallel with pooled CI study.", "": "" }, { "Text": "Table 3 - Data Package Elements – First and Secondary Pooled Candidate Identification Studies for each of SCS, IVT, and IC", "": "" }, { "Text": "Category Analysis Assay Results Responsible Party", "": "" }, { "Text": "NHP", "": "" }, { "Text": "Biodistribution", "": "" }, { "Text": "Protein expression", "": "" }, { "Text": "Single cell RNA sequencing as appropriate", "": "" }, { "Text": "Clinical pathology (if needed, investigational and as agreed by RWG)", "": "" }, { "Text": "Histopathology (if needed, investigational and as agreed by RWG)", "": "" }, { "Text": "Rabbit", "": "" }, { "Text": "Biodistribution -target tissues", "": "" }, { "Text": "Rodent", "": "" }, { "Text": "Biodistribution -target tissues", "": "" }, { "Text": "Ex vivo immunogenicity assays to be conducted as needed*", "": "" }, { "Text": "IFN-y ELISpot", "": "" }, { "Text": "NAb", "": "" }, { "Text": "Will be performed post-hoc against parent capsid on serum samples collected once pre-dose and bi-weekly post-dose, including terminal collection, to assess development of response against whole pool", "": "" }, { "Text": "BAb", "": "" }, { "Text": "Multiplex cytokine/chemokine", "": "" }, { "Text": "Complement (CH50 and/or AH50 standard assays)", "": "" }, { "Text": "If samples come back positive, can follow up to evaluate binding directly to specific capsid candidates", "": "" }, { "Text": "In vitro", "": "" }, { "Text": "FTO**", "": "" }, { "Text": "Capsid Quality Attributes", "": "" }, { "Text": "Achievable titer using platform production", "": "" }, { "Text": "Aggregation - representative cargo", "": "" }, { "Text": "*Immunogenicity assays are optional and would be conducted as agreed by RWG, and may be utilized in investigational manner.", "": "" }, { "Text": "**FTO search to be conducted by Capsida prior to or in parallel with pooled CI study.", "": "" }, { "Text": "Note: Capsid specific binding antibody assay, neutralizing antibody assay, and IFN-y ELISpot can be tech transferred after selection of development candidate.", "": "" }, { "Text": "Table 4 –Final Pooled Candidate Identification Studies for each of IVT, SCS, IC", "": "" }, { "Text": "Category Analysis Assay Results Responsible Party", "": "" }, { "Text": "NHP", "": "" }, { "Text": "Biodistribution", "": "" }, { "Text": "Protein expression", "": "" }, { "Text": "Single cell RNA sequencing as appropriate", "": "" }, { "Text": "Clinical pathology (if needed, investigational and as agreed by RWG)", "": "" }, { "Text": "Histopathology (if needed,investigational and as agreed by RWG)", "": "" }, { "Text": "Rabbit", "": "" }, { "Text": "Biodistribution -target tissues", "": "" }, { "Text": "Rodent", "": "" }, { "Text": "Biodistribution -target tissues", "": "" }, { "Text": "Ocular tolerability / safety as agreed by RWG, with exception of urgent situations where AbbVie may collect samples at their discretion", "": "" }, { "Text": "Ex vivo immunogenicity to be conducted as needed*", "": "" }, { "Text": "IFN-y ELISpot on NHP samples", "": "" }, { "Text": "NAb on NHP samples", "": "" }, { "Text": "Will be performed post-hoc against parent capsid on serum samples collected once pre-dose and bi-weekly post-dose, including terminal collection, to assess development of response against whole pool", "": "" }, { "Text": "BAb on NHP samples", "": "" }, { "Text": "Multiplex cytokine/chemokine on NHP samples", "": "" }, { "Text": "Complement (CH50 and/or AH50 standard assays) on NHP samples", "": "" }, { "Text": "If samples come back positive, can follow up to evaluate binding directly to specific capsid candidates", "": "" }, { "Text": "In vitro and in silico immunogenicity assays**", "": "" }, { "Text": "▪ U937 cells", "": "" }, { "Text": "▪ THP1 cells with and without TLR9 overexpression", "": "" }, { "Text": "▪ HEK293 reporter cells overexpressing specific hTLRs (2/4/9)", "": "" }, { "Text": "In silico T cell epitope prediction on individual capsid candidates", "": "" }, { "Text": "▪ AbbVie to assess risk by in silico T cell epitope prediction in comparison to benchmark AAV sequences (AAV2, AAV8, competitors)", "": "" }, { "Text": "In vitro", "": "" }, { "Text": "FTO***", "": "" }, { "Text": "Capsid Quality Attributes", "": "" }, { "Text": "Achievable titer using platform production", "": "" }, { "Text": "Aggregation - representative cargo", "": "" }, { "Text": "*Immunogenicity assays with exception of in vitro assays on individual capsid candidates are optional and would be conducted as agreed by RWG, and may be utilized in investigational manner.", "": "" }, { "Text": "**In vitro immunogenicity assays and in silico T cell epitope prediction would be conducted in parallel with in-life for this study as part of risk assessment.", "": "" }, { "Text": "***FTO search to be conducted prior to or in parallel with pooled CI study.", "": "" }, { "Text": "Note: some immunogenicity in vitro assays are still under development and will be completed prior to completion of pooled candidate identification study. For all in vitro assays, outputs include analysis of cell death and multiplex cytokine response. Capsid specific binding antibody assay, neutralizing antibody assay, and IFN-y ELISpot can be tech transferred after selection of development candidate.", "": "" }, { "Text": "Table 5 –Final Ophthalmology Data package Elements - Single Variant Characterization Studies for each of SCS, IVT, and IC", "": "" }, { "Text": "Category Analysis Assay Results Responsible Party", "": "" }, { "Text": "NHP", "": "" }, { "Text": "Protein expression", "": "" }, { "Text": "Single cell RNA sequencing", "": "" }, { "Text": "Histopathology (as agreed by RWG)", "": "" }, { "Text": "Clinical pathology", "": "" }, { "Text": "Rodent if needed as agreed by RWG", "": "" }, { "Text": "Rabbit if needed as agreed by RWG", "": "" }, { "Text": "NHP", "": "" }, { "Text": "Ex vivo Immunogenicity assays", "": "" }, { "Text": "IFN-y ELISpot on NHP samples", "": "" }, { "Text": "NAb on NHP samples", "": "" }, { "Text": "Will be performed post-hoc against parent capsid on serum samples collected once pre-dose and bi-weekly post-dose, including terminal collection, to assess development of response against whole pool", "": "" }, { "Text": "BAb on NHP samples", "": "" }, { "Text": "Multiplex cytokine/chemokine on NHP samples", "": "" }, { "Text": "Complement (CH50 and/or AH50 standard assays) on NHP samples", "": "" }, { "Text": "If samples come back positive, can follow up to evaluate binding directly to specific capsid candidates", "": "" }, { "Text": "Capsid Quality Attributes", "": "" }, { "Text": "Achievable titer using platform production", "": "" }, { "Text": "Aggregation - representative cargo", "": "" }, { "Text": "Packaging efficiency (empty/full ratio) – representative cargo*", "": "" }, { "Text": "Stability – representative cargo*", "": "" }, { "Text": "-3x freeze thaw aggregation & titer", "": "" }, { "Text": "*To be conducted in parallel with in-life for Single Variant Characterization Study", "": "" }, { "Text": "Note: Capsid-specific binding antibody assay, neutralizing antibody assay, and IFN-y ELISpot can be tech transferred after selection of development candidate.", "": "" }, { "Text": "Budget", "": "" }, { "Text": "Exhibit E", "": "" }, { "Text": "Initial Target List", "": "" }, { "Text": "# Gene Target Name Aliases Gene ID Notes:", "": "" }, { "Text": "1 SEMA3A Semaphorin3A 10371", "": "" }, { "Text": "2 RTN4R Reticulon 4 Receptor NOGOR 65078", "": "" }, { "Text": "3 OSMR Oncostatin M OSM 9180", "": "" }, { "Text": "4 NTRK1 Neurotrophic Receptor Tyrosine Kinase 1", "": "" }, { "Text": "5 NTRK2 Neurotrophic Receptor Tyrosine Kinase 2", "": "" }, { "Text": "6 CNTFR Ciliary Neurotrophic Factor Receptor", "": "" }, { "Text": "7 GFRA1 GDNF Family Receptor Alpha1 2674", "": "" }, { "Text": "8 C5 Complement Component 5 727", "": "" }, { "Text": "9 CFI Complement Factor I 3426", "": "" }, { "Text": "10 RGMa Repulsive Guidance Molecule BMP Co-Receptor A", "": "" }, { "Text": "11 ANGPT2 Angiopoietin 2 285", "": "" }, { "Text": "12 TEK Tyrosine Kinase with Ig and EGF Homology Domains-2", "": "" }, { "Text": "13 APOE Apolipoprotein E 348", "": "" }, { "Text": "14 MMP1 Matrix Metalloproteinase 1 CLG, CLGN 4312", "": "" }, { "Text": "15 MMP9 Matrix Metalloproteinase 9 CLG4b, GELB 4318", "": "" }, { "Text": "16 MMP3 Matrix Metalloproteinase 3 4314", "": "" }, { "Text": "17 FASLG Fas Ligand CD178, CD95L, TNFSF6", "": "" }, { "Text": "18 TREM2 Triggering Receptor Expressed on Myeloid Cells 2", "": "" }, { "Text": "19 DCN Decorin 1634", "": "" }, { "Text": 20, "": "" }, { "Text": "SCHEDULE 1.56", "": "" }, { "Text": "Trademarks and logos", "": "" }, { "Text": "Logo:", "": "" }, { "Text": "Trademark:", "": "" }, { "Text": "▪ Capsida Biotherapeutics trademark filed (pending): WIPO Ref. 1424582701", "": "" }, { "Text": "SCHEDULE 1.75", "": "" }, { "Text": "B10, B22, C1, C2, C3", "": "" }, { "Text": "SCHEDULE 1.88", "": "" }, { "Text": "FTE Rate", "": "" }, { "Text": "Research & Discovery: $425,000", "": "" }, { "Text": "Development: $375,000", "": "" }, { "Text": "Manufacturing: $375,000", "": "" }, { "Text": "Commercial: $425,000", "": "" }, { "Text": "Med Affairs: $350,000", "": "" }, { "Text": "SCHEDULE 5.1.2", "": "" }, { "Text": "Existing CMO Agreements", "": "" }, { "Text": "Vendor Name", "": "" }, { "Text": "DNA TwoPointO Inc (ATUM)", "": "" }, { "Text": "Aldevron", "": "" }, { "Text": "Charles River", "": "" }, { "Text": "Millipore Sigma (BioReliance Corporation)", "": "" }, { "Text": "KBI", "": "" }, { "Text": "AdVec", "": "" }, { "Text": "Life Tech / Thermo", "": "" }, { "Text": "SCHEDULE 6.3.3", "": "" }, { "Text": "Co-Promotion Readiness Plan", "": "" }, { "Text": "Elements of Co-Promotion Readiness Plan", "": "" }, { "Text": "A. Elements of Co-Promotion Readiness. The Co-Promotion Readiness Plan prepared by Capsida and provided to AbbVie pursuant to Section 6.3.3(a) must contain all of following elements to demonstrate that Capsida will have adequate resources and expertise to co-promote the Co-Promotion Product during the applicable Co-Promotion Period in the United States, as and when needed during the pre-launch, launch and post-launch periods:", "": "" }, { "Text": "1. Upon delivery by Capsida to AbbVie of the Co-Promotion Option Exercise Notice for the Co-Promotion Product and the Co-Promotion Readiness Plan, Capsida must have:", "": "" }, { "Text": "a. Hired a Chief Commercial Officer or equivalent position, which individual has adequate prior experience managing the promotion of a neurological disease therapeutic product and the build-out of a commercial organization targeting neurological disease therapeutic products in the United States; and", "": "" }, { "Text": "b. Complete hiring profiles, that are consistent with industry practice for similar positions, for all management positions, including first- and higher-level managers for the sales force, sales force trainers, sale force operations and legal, regulatory and ethics/compliance sales force support, and all sales representative positions.", "": "" }, { "Text": "2. Upon delivery by Capsida to AbbVie of the Co-Promotion Option Exercise Notice for the Co-Promotion Product and the Co-Promotion Readiness Plan, or, if such Exercise Notice occurs before the delivery by AbbVie to the JGC of the ALS Commercialization Plan, within sixty (60) days of delivery by AbbVie of such plan, the foregoing elements (in item 1) must continue to be satisfied and Capsida must have reasonably detailed timelines and budgets (including FTE-based staffing costs) for achieving all of the following pre-launch, launch and post-launch elements as set forth in Sections A.3 – A.6 of this Schedule 6.3.3, which timelines and budgets must be consistent with such ALS Commercialization Plan (including number of Capsida sales representatives and their call plans and assigned territories).", "": "" }, { "Text": "3. At the United States BLA submission date for the Co-Promotion Product, the foregoing elements (in items 1 and 2) must continue to be satisfied and Capsida must have:", "": "" }, { "Text": "a. A functioning sales force operations system that is consistent with industry practice and capable of tracking and measuring complete sales force metrics in accordance with the Co-Promotion Agreement and the then-current ALS Commercialization Plan provided by AbbVie to the JGC;", "": "" }, { "Text": "b. A complete sales force compensation and incentive plan in draft form for alignment with AbbVie's compensation and incentive plan;", "": "" }, { "Text": "c. Completed hiring of all management positions, including first- and higher-level managers for the sales force, sales force trainers, sales force operations and legal, regulatory and ethics/compliance sales force support, which individuals have adequate prior experience managing the promotion of a neurological disease therapeutic product in the United States, as reasonably acceptable to AbbVie;", "": "" }, { "Text": "d. Adequate and customary legal, regulatory and ethics/compliance processes in place designed to ensure Capsida's co-promotion activities are conducted in compliance with AbbVie's Code of Business Conduct and all Applicable Laws; and", "": "" }, { "Text": "e. Reasonably detailed updated timelines and budgets (including FTE-based staffing costs) for achieving all of the following pre-launch, launch and post-launch elements as set forth in Sections A.4 – A.6 of this Schedule 6.3.3, which timelines and budgets must be consistent with the then-current ALS Commercialization Plan (including number of Capsida sales representatives and their call plans and assigned territories) provided by AbbVie to the JGC.", "": "" }, { "Text": "4. Within two (2) months after the United States BLA submission date for the Co-Promotion Product, the foregoing elements (items 1-3) must continue to be satisfied and Capsida must have:", "": "" }, { "Text": "a. Completed hiring of all sales representatives allocated to Capsida in the then-current ALS Commercialization Plan provided by AbbVie to the JGC, with (i) at least two-thirds (2/3) of such sales representatives having adequate prior experience Detailing products for a neurological disease and demonstrating adequate knowledge of the customer base in the United States and (ii) all such sales representatives being ready to commence training and conduct pre-launch activities promptly after being hired; and", "": "" }, { "Text": "b. Reasonably detailed updated timelines and budgets (including FTE-based staffing costs) for achieving all of the following pre-launch, launch and post-launch elements as set forth in Sections A.5 – A.6 of this Schedule 6.3.3, which timelines and budgets must be consistent with the then-current ALS Commercialization Plan provided by AbbVie to the JGC.", "": "" }, { "Text": "5. At least two (2) months prior to the date established by FDA pursuant to the Prescription Drug User Fee Act for completing the review of the BLA for the Co-Promotion Product in the United States, the foregoing elements (items 1-4) must continue to be satisfied and Capsida must have:", "": "" }, { "Text": "a. Completed training and testing for all sales representatives in accordance with the training program and materials established for the Co-Promotion Products;", "": "" }, { "Text": "b. Implemented customer account targeting, segmentation, profiling, and planning in accordance with the Co-Promotion Agreement and the ALS Commercialization Plan; and", "": "" }, { "Text": "c. Reasonably detailed updated timelines and budgets (including FTE-based staffing costs) for achieving all of the pre-launch, launch and post-launch elements as set forth in Sections A.5 – A.6 of this Schedule 6.3.3, which timelines and budgets must be consistent with the then current ALS Commercialization Plan provided by AbbVie to the JGC.", "": "" }, { "Text": "6. From and after receipt of Regulatory Approval of the BLA for the Co-Promotion Product in the United States, the foregoing elements (items 1-5) must continue to be satisfied and Capsida must:", "": "" }, { "Text": "a. Conduct all co-promotion activities with respect to the Co-Promotion Products in the United States in accordance with the then-current ALS Commercialization Plan provided by AbbVie to the JGC and otherwise in accordance with the Co-Promotion Agreement and this Agreement; and", "": "" }, { "Text": "b. Conduct all co-promotion activities with respect to the Co-Promotion Products in the United States in compliance with AbbVie's Code of Business Conduct and all Applicable Laws.", "": "" }, { "Text": "B. Consequences of Non-Compliance with Co-Promotion Readiness. If AbbVie reasonably determines pursuant to Section 6.3.3 that Capsida is not in compliance with, or is not reasonably likely to comply with, the Co-Promotion Readiness Plan, AbbVie shall deliver written notice of such determination to Capsida (each, a \"Non-Compliance Notice\") and the following consequences shall apply, as applicable:", "": "" }, { "Text": "1. If AbbVie reasonably determines that Capsida has not satisfied or is not reasonably likely to satisfy each of the elements of the Co-Promotion Readiness Plan identified in A.3.a, A.3.c (with respect to hiring sales trainers and legal, regulatory and ethics/compliance sales support), A.3.d, and A.5.a (such elements, the \"Co-Promotion Compliance Readiness Elements\") as of the required date, Capsida shall not perform any Details with respect to any Co-Promotion Product until the date that is six (6) months after the later of (i) the date Capsida has satisfied all of the Co-Promotion Compliance Readiness Elements and (ii) receipt of all Regulatory Approvals for the applicable Co-Promotion Product in the United States.", "": "" }, { "Text": "2. If AbbVie reasonably determines that Capsida has satisfied each of the Co-Promotion Compliance Readiness Elements as of the required date but has not satisfied or is not reasonably likely to satisfy any of the other elements of the Co-Promotion Readiness Plan as of the required date, AbbVie shall have the right to reduce Capsida's percentage of the Details with respect to the Co-Promotion Product in the United States as follows (but for clarity, such reduction shall not reduce Capsida's share of the Allowable Expenses):", "": "" }, { "Text": "a. If AbbVie reasonably determines that Capsida has not satisfied or is not reasonably likely to satisfy element A.3.c (with respect to first- and higher-level managers for the sales force) or element A.4.a of the Co-Promotion Readiness Plan as of the required date, but Capsida has hired in excess of fifty percent (50%) of both (x) the required first- and higher-level managers for the sales force in accordance with element A.3.c and (y) the required sales representatives in accordance with element A.4.a, as applicable, as of the required date (and has otherwise satisfied all elements of the Co-Promotion Readiness Plan, including the Co-Promotion Compliance Readiness Elements), then AbbVie shall have the right to reduce Capsida's percentage of the Details with respect to the Co-Promotion Product in the United States by fifty percent (50%) of the Details elected by Capsida with respect to the Co-Promotion Product in the United States until the date that is six (6) months after the later of (a) the date upon which Capsida has satisfied all of the elements of the Co-Promotion Readiness Plan and (b) receipt of all Regulatory Approvals for the Co-Promotion Product in the United States; and", "": "" }, { "Text": "3. If AbbVie reasonably determines that Capsida has not satisfied or is not reasonably likely to satisfy (a) any element of the Co-Promotion Readiness Plan (other than element A.3.c (with respect to first- and higher-level managers for the sales force), element A.4.a or the Co-Promotion Compliance Readiness Elements) or (b) element A.3.c (with respect to first- and higher-level managers for the sales force) or element A.4.a of the Co-Promotion Readiness Plan as of the required date, but Capsida has hired fifty percent (50%) or less of both (i) the required first- and higher-level managers for the sales force in accordance with element A.3.c and (ii) the required sales representatives in accordance with element A.4.a, as applicable, as of the required date, Capsida shall not perform any Details with respect to the Co-Promotion Product until the date that is six (6) months after the later of (x) the date upon which Capsida has satisfied all of the elements of the Co-Promotion Readiness Plan and (y) receipt of all Regulatory Approvals for the Co-Promotion Product in the United States. If AbbVie reasonably determines that Capsida has not satisfied any of the elements of the Co-Promotion Readiness Plan as of the required date and thereafter fails to satisfy such element within six (6) months after such required date, AbbVie shall have the right to terminate Capsida's Co-Promotion Option.", "": "" }, { "Text": "SCHEDULE 11.5A", "": "" }, { "Text": "Press Release", "": "" }, { "Text": "Capsida Biotherapeutics Debuts with $140 Million of Capital", "": "" }, { "Text": "– Versant, Westlake Village BioPartners launch next-generation gene therapy company with $50 million Series A –", "": "" }, { "Text": "–Collaboration with AbbVie provides $90 million in up front and equity investment capital to create tissue-targeted gene therapies for three CNS disease targets –", "": "" }, { "Text": "THOUSAND OAKS, Calif., April XX, 2021 – Versant Ventures and Westlake Village BioPartners today announced the emergence from stealth mode of Capsida Biotherapeutics Inc., a biotechnology company using an adeno-associated virus (AAV) engineering and cargo development platform to develop tissue-targeted gene therapies for multiple types of diseases. In addition to a $50 million Series A commitment from the two firms, Capsida also announced a multi-year strategic collaboration and option agreement with AbbVie that provides $90 million in up front and equity investment capital in addition to potential future option, development and commercial milestone payments. The collaboration is aimed at developing best-in-class, targeted gene therapies for three programs in serious neurodegenerative diseases.", "": "" }, { "Text": "Our high-throughput AAV engineering platform is designed to identify differentiated capsids and cargos that will successfully deliver gene therapies with superior cell and tissue targeting and safety profiles than current-generation products in both CNS and non-CNS diseases,\" said Robert Cuddihy, M.D., chief executive officer of Capsida. \"We are very pleased to debut today with the backing of experienced company creators in Versant and Westlake, as well as with a significant pharma partnership with AbbVie.", "": "" }, { "Text": "A next-generation AAV and cargo platform", "": "" }, { "Text": "Although current gene therapy approaches have shown dramatic efficacy in several rare diseases, the medicines are hindered by imprecise targeting, an inability to transduce a number of cell types and tissues effectively, and safety liabilities. Specifically, most current-generation approaches use naturally occurring serotypes of AAV that have limitations in their ability to transduce desired cell types with a therapeutic gene product. Due to lower transduction efficacy, these products may need to be delivered at higher doses and thus may be more likely to induce immunogenic responses and adverse events.", "": "" }, { "Text": "As a result, many monogenetic and sporadic neurodegenerative disorders yet remain unaddressed by this therapeutic modality.", "": "" }, { "Text": "Capsida is addressing these concerns with its AAV engineering platform that generates capsids optimized to target specific tissue types and limits transduction of tissues and cell types that are not relevant to the target disease, allowing for improved efficacy and safety. In addition, Capsida is developing proprietary cargo that delivers effective gene replacement or enhancement customized for the specific disease of interest.", "": "" }, { "Text": "The platform originated from groundbreaking research in the laboratory of Viviana Gradinaru, Ph.D., Professor of Neuroscience and Biological Engineering, Heritage Medical Research Institute Investigator, and Director of the Center for Molecular and Cellular Neuroscience at the Tianqiao and Chrissy Chen Institute for Neuroscience at Caltech. The platform uses machine learning, structural biology, non-human primate models, and human tissue models to screen billions of engineered capsids for the ability to target desired tissue types precisely.", "": "" }, { "Text": "The company's engineered capsids have demonstrated markedly enhanced tissue tropism for neurons versus astrocytes, glia, and other CNS cell types, thus demonstrating potential to unlock treatments for disorders requiring neuronal transduction that exceeds the performance of first-generation AAV9-based therapies.", "": "" }, { "Text": "With our long-standing track record in the gene therapy space, it is gratifying to help launch Capsida, which is taking a novel approach to developing genetic medicines,\" said Clare Ozawa, Ph.D., managing director at Versant and a Capsida board member.", "": "" }, { "Text": "Collaboration with AbbVie", "": "" }, { "Text": "Capsida's newly announced collaboration with AbbVie will use the biotech's platform to identify and advance clinically translatable capsids paired with an innovative therapeutic approach from AbbVie to create tissue-targeted gene therapies for three CNS disease targets.", "": "" }, { "Text": "Under the terms of the agreement, Capsida will receive $80 million up front in cash and a $10 million equity investment. For targets one and two, upon AbbVie exercising its option, Capsida is eligible to receive $530 million in option and development milestone payments excluding commercial milestone payments. Capsida is also eligible to receive up to high single-digit royalty payments on future product sales. Following AbbVie's exercise of its options for these programs, AbbVie will be solely responsible for further development and commercialization.", "": "" }, { "Text": "For the third disease target, upon AbbVie exercising its option, Capsida will have the right to develop through human proof-of-concept, and AbbVie would lead late-stage development and commercialization. Following human proof-of-concept, the parties would enter into a 50/50 cost:profit share with Capsida having the option to co-promote in the US.", "": "" }, { "Text": "For all three programs, Capsida will lead capsid discovery efforts using its high throughput AAV engineering and screening platform and AbbVie will contribute innovative therapeutic approaches. Capsida will also be responsible for process development and early clinical manufacturing of all programs.", "": "" }, { "Text": "We are excited to enter this licensing agreement with Capsida. By combining Capsida's deep understanding of the structure-function relationship of AAV biology with AbbVie's innovative cargo therapeutic technologies, we will strive to develop highly effective and transformative gene therapies for patients with devastating CNS disorders,\" said Eric Karran, Ph.D., Vice President, Neuroscience Discovery at AbbVie.", "": "" }, { "Text": "Capsida operating plans", "": "" }, { "Text": "Capsida's initial internal preclinical programs center on neurodevelopmental and neurodegenerative disorders, areas in which gene therapies have yet to gain significant traction due to the difficulties of targeting the brain. Based on progress to date, Capsida expects to start IND-enabling work on its first development candidates during 2021 and to start clinical trials in 2022.", "": "" }, { "Text": "In addition to continuing preclinical work on its lead assets, the company plans to use proceeds from its $50 million Series A financing to open its state-of-the-art manufacturing facility this year and advance its platform into non-CNS disorders.", "": "" }, { "Text": "The company is operating from its site in Thousand Oaks, California.", "": "" }, { "Text": "Capsida is another example of the growing biotech hub in the Greater Los Angeles area,\" said Beth Seidenberg, M.D., founding managing director at Westlake Village BioPartners and a Capsida board member. \"Westlake Village BioPartners is proud to be catalyzing this growth. Capsida is led by an outstanding team of executives and we are looking forward to growing the team to support our internal pipeline and the AbbVie collaboration.", "": "" }, { "Text": "With the anchor investment from Versant and Westlake, and the collaboration with AbbVie, Capsida plans to expand its 50-member team to about 100 scientists this year. To capture the expanding opportunities in the field of gene therapy, Capsida will pursue additional strategic opportunities in parallel with financial investors over the coming months.", "": "" }, { "Text": "About Capsida Biotherapeutics", "": "" }, { "Text": "Capsida Biotherapeutics Inc. is developing tissue-targeted gene therapies using its biologically driven, high-throughput adeno-associated virus (AAV) engineering and proprietary cargo development platform. As a fully integrated gene therapy company, Capsida is combining its differentiated AAV engineering and screening capabilities with cargo development and state-of-the-art manufacturing to establish a proprietary pipeline of groundbreaking gene therapies across a range of therapeutic areas for indications that are unreachable with current technologies. The company's leadership is backed by decades of successful biologics manufacturing experience and deep AAV biology expertise. Visit us at www.capsida.com  to learn more.", "": "" }, { "Text": "About Versant Ventures", "": "" }, { "Text": "Versant Ventures is a leading healthcare venture capital firm committed to helping exceptional entrepreneurs build the next generation of great companies. The firm's emphasis is on biotechnology companies that are discovering and developing novel therapeutics. With $4.2 billion under management and offices in the U.S., Canada and Europe, Versant has built a team with deep investment, operating and R&D expertise that enables a hands-on approach to company building. Since the firm's founding in 1999, more than 75 Versant companies have achieved successful acquisitions or IPOs. For more information, please visit www.versantventures.com .", "": "" }, { "Text": "About Westlake Village BioPartners", "": "" }, { "Text": "Westlake Village BioPartners is a Los Angeles area-based venture capital firm focused on incubating and building life sciences companies with entrepreneurs who have the potential to bring transformative therapies to patients. Westlake manages more early stage venture capital solely from the greater Los Angeles area than any other firm. The Westlake model is built on the founding team's unique experience in successfully identifying and developing breakthrough therapies and building organizations, based on their extensive R&D experience. For more information, please visit www.westlakebio.com .", "": "" }, { "Text": "Media Contacts:", "": "" }, { "Text": "Versant", "": "" }, { "Text": "Steve Edelson", "": "" }, { "Text": "(415) 801-8088", "": "" }, { "Text": "sedelson@versantventures.com", "": "" }, { "Text": "Westlake Village BioPartners", "": "" }, { "Text": "Greig Communications, Inc.", "": "" }, { "Text": "Kathy Vincent", "": "" }, { "Text": "(310) 403-8951", "": "" }, { "Text": "kathy@greigcommunications.com", "": "" }, { "Text": "# # #", "": "" }, { "Text": "SCHEDULE 11.5B", "": "" }, { "Text": "AbbVie and Capsida Biotherapeutics Expand Strategic Collaboration to Develop Targeted Genetic Medicines for Eye Diseases with High Unmet Need", "": "" }, { "Text": "- Partnership Combines AbbVie's extensive capabilities with Capsida's novel adeno-associated virus (AAV) engineering platform", "": "" }, { "Text": "- Builds upon the neurodegenerative disease partnership announced in 2021", "": "" }, { "Text": "NORTH CHICAGO, Ill. and THOUSAND OAKS, Calif. – February 23, 2023 – AbbVie (NYSE: ABBV) and Capsida Biotherapeutics Inc. (\"Capsida\") today announced an expanded strategic collaboration to develop genetic medicines for eye diseases with high unmet need. AbbVie's extensive capabilities will be paired with Capsida's novel adeno-associated virus (AAV) engineering platform and manufacturing capability to identify and advance three programs. The collaboration builds upon the neurodegenerative disease partnership announced in 2021.", "": "" }, { "Text": "This expanded collaboration with Capsida has the potential to develop transformative therapies for patients with serious eye diseases,\" said Jonathon Sedgwick, Ph.D., vice president and global head of discovery research, AbbVie. \"In pursuing the promise of genetic medicine-based therapeutics, AbbVie continues to expand our capabilities, and we are pleased to have Capsida as a partner.", "": "" }, { "Text": "AbbVie has been an excellent partner, and we are excited to expand our collaboration into ophthalmology with the world leader in this therapeutic area,\" said Peter Anastasiou, chief executive officer of Capsida. \"Combining AbbVie's expertise in eye disease drug development and commercialization with Capsida's fully integrated next-generation AAV engineering platform and manufacturing capabilities offers the potential to provide novel therapies enabling unprecedented benefit to patients with serious eye diseases.", "": "" }, { "Text": "Under the terms of the expanded agreement, Capsida will receive $70 million, consisting of upfront payments and a potential equity investment. For the three programs, Capsida may be eligible to receive up to $595 million in option fees and research and development milestones, with potential for further commercial milestones. Capsida is also eligible to receive mid-to-high single-digit royalty payments on future product sales. Capsida will lead capsid discovery efforts for all programs using its high throughput AAV engineering platform and will be responsible for process development and early clinical manufacturing. AbbVie will lead innovative therapeutic cargo approaches and be responsible for development and commercialization.", "": "" }, { "Text": "About AbbVie", "": "" }, { "Text": "AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.", "": "" }, { "Text": "About Capsida Biotherapeutics", "": "" }, { "Text": "Capsida Biotherapeutics is a fully integrated next-generation gene therapy platform company. Capsida's approach unlocks the potential to treat both rare and common diseases across all ages. We create customized therapies that selectively target specific organ systems and simultaneously limit exposure to non-targeted organs. The company has wholly owned programs in CNS and strategic collaborations with AbbVie (CNS and eye care), Lilly (CNS), and CRISPR Therapeutics (CNS), providing independent validation of Capsida's capabilities. Capsida is backed by Versant Ventures and Westlake Village BioPartners. Its platform originated from groundbreaking research in the laboratory of Viviana Gradinaru, Ph.D., a neuroscience professor at the California Institute of Technology. Visit us at www.capsida.com  to learn more.", "": "" }, { "Text": "Forward-Looking Statements", "": "" }, { "Text": "Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words \"believe,\" \"expect,\" \"anticipate,\" \"project\" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits from AbbVie's acquisition of Allergan plc (\"Allergan\"), failure to promptly and effectively integrate Allergan's businesses, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, \"Risk Factors,\" of AbbVie's 2021 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.", "": "" }, { "Text": "Contacts:", "": "" }, { "Text": "For AbbVie", "": "" }, { "Text": "Media", "": "" }, { "Text": "Frank Benenati", "": "" }, { "Text": "(847) 938-8745", "": "" }, { "Text": "frank.benenati@abbvie.com", "": "" }, { "Text": "Investors", "": "" }, { "Text": "Liz Shea", "": "" }, { "Text": "(847) 935-2211", "": "" }, { "Text": "liz.shea@abbvie.com", "": "" }, { "Text": "For Capsida", "": "" }, { "Text": "Kathy Vincent", "": "" }, { "Text": "Greig Communications, Inc.", "": "" }, { "Text": "kathy@greigcommunications.com", "": "" }, { "Text": "SCHEDULE 12.2", "": "" }, { "Text": "Initial Neurology Disclosure Schedule", "": "" }, { "Text": "SCHEDULE 12.3", "": "" }, { "Text": "Initial Ophthalmology Disclosure Schedule", "": "" }, { "Text": "Intentionally left blank.", "": "" }, { "Text": "SCHEDULE 12.2.1", "": "" }, { "Text": "A: Existing In-License Agreements as of the Original Agreement Effective Date", "": "" }, { "Text": "1. License Agreement by and Between Capsida and Caltech dated August 5, 2019 and as amended September 1, 2020", "": "" }, { "Text": "2. Life Technologies Cell Line License Agreement by and between Capsida and Life Technologies Corp. dated February 10, 2021.", "": "" }, { "Text": "3. License Agreement by and between Capsida and Advec Inc dated July 8, 2020.", "": "" }, { "Text": "B: Future Capsida In-License Agreements for Neurology Program", "": "" }, { "Text": "SCHEDULE 12.2.4", "": "" }, { "Text": "Existing NP Patents", "": "" }, { "Text": "BR Ref Serial Number Filing Date", "": "" }, { "Text": "CAPS-001/00US", "": "" }, { "Text": "CAPS-002/00US", "": "" }, { "Text": "CAPS-001/01US", "": "" }, { "Text": "CAPS-001/02US", "": "" }, { "Text": "CAPS-001/01WO", "": "" }, { "Text": "CAPS-001/01SG", "": "" }, { "Text": "CAPS-001/01KR", "": "" }, { "Text": "CAPS-001/01AU", "": "" }, { "Text": "CAPS-001/01EP", "": "" }, { "Text": "CAPS-001/01JP", "": "" }, { "Text": "CAPS-001/01CN", "": "" }, { "Text": "CAPS-001/01CA", "": "" }, { "Text": "CAPS-004/00US", "": "" }, { "Text": "CAPS-004/01WO", "": "" }, { "Text": "CAPS-004/01US", "": "" }, { "Text": "CAPS-004/01EP", "": "" }, { "Text": "CAPS-004/01CA", "": "" }, { "Text": "CAPS-004/01AU", "": "" }, { "Text": "CAPS-004/01KR", "": "" }, { "Text": "CAPS-004/01SG", "": "" }, { "Text": "CAPS-004/01JP", "": "" }, { "Text": "CAPS-004/01CN", "": "" }, { "Text": "CAPS-004/01HK", "": "" }, { "Text": "CAPS-008/00US", "": "" }, { "Text": "CAPS-008/01WO", "": "" }, { "Text": "CAPS-011/00US", "": "" }, { "Text": "CAPS-011/01WO", "": "" }, { "Text": "CAPS-012/00US", "": "" }, { "Text": "CAPS-012/01WO", "": "" }, { "Text": "CAPS-013/00US", "": "" }, { "Text": "CAPS-013/01WO", "": "" }, { "Text": "CAPS -014/00US", "": "" }, { "Text": "CAPS-014/01US", "": "" }, { "Text": "CAPS-014/01WO", "": "" }, { "Text": "CAPS-019/00US", "": "" }, { "Text": "CAPS-020/00US", "": "" }, { "Text": "CAPS-021/00US", "": "" }, { "Text": "CAPS-024/00US", "": "" }, { "Text": "CAPS-025/00US", "": "" }, { "Text": "CAPS-026/00US", "": "" }, { "Text": "CAPS-027/00US", "": "" }, { "Text": "CAPS-028/00US", "": "" }, { "Text": "CAPS-028/01WO", "": "" }, { "Text": "CAPS-029/00US", "": "" }, { "Text": "CAPS-029/01WO", "": "" }, { "Text": "CAPS-030/00US", "": "" }, { "Text": "CAPS-030/01WO", "": "" }, { "Text": "CALTECH-LICENSED-1", "": "" }, { "Text": "CALTECH-LICENSED-2", "": "" }, { "Text": "SCHEDULE 12.3.1", "": "" }, { "Text": "A: Existing In-License Agreements as of the Original Agreement Effective Date", "": "" }, { "Text": "License Agreement by and Between Capsida and Caltech dated August 5, 2019 and as amended September 1, 2020", "": "" }, { "Text": "Life Technologies Cell Line License Agreement by and between Capsida and Life Technologies Corp. dated February 10, 2021.", "": "" }, { "Text": "License Agreement by and between Capsida and Advec Inc dated July 8, 2020.", "": "" }, { "Text": "B: Future Capsida In-License Agreements for Ophthalmology Program", "": "" }, { "Text": "SCHEDULE 12.3.4", "": "" }, { "Text": "Existing OP Patents", "": "" }, { "Text": "[Same as 12.2.4 as of the Effective Date]", "": "" }, { "Text": "SCHEDULE 15.6.3", "": "" }, { "Text": "ADR Procedures", "": "" }, { "Text": "Any Dispute referred to ADR under this Agreement shall be resolved as follows:", "": "" }, { "Text": "1. To begin an ADR proceeding, a Party shall provide written notice to the other Party of the Dispute to be resolved by ADR. Within fourteen (14) days after its receipt of such notice, the other Party may, by written notice to the Party initiating the arbitration, add additional issues to be resolved within the same ADR.", "": "" }, { "Text": "2. Within twenty-one (21) days following the initiation of the ADR proceeding, the Parties shall select a mutually acceptable independent, impartial and conflicts-free neutral to preside in the resolution of all issues in this ADR proceeding. If the Parties are unable to agree on a mutually acceptable neutral within such period, each Party will select one (1) independent, impartial and conflicts-free neutral and those two (2) neutrals will select a third independent, impartial and conflicts-free neutral within ten (10) days thereafter (such neutral(s), the \"Neutral\"). None of the neutrals selected may be current or former employees, officers or directors of either Party or any of its Affiliates.", "": "" }, { "Text": "3. No earlier than twenty-eight (28) days or later than fifty-six (56) days after selection, the Neutral shall hold a hearing to resolve each of the issues identified by the Parties. The ADR proceeding shall take place at a location agreed upon by the Parties. If the Parties cannot agree, the Neutral shall designate a location other than the principal place of business of either Party or any of their Affiliates.", "": "" }, { "Text": "4. At least seven (7) days prior to the hearing, each Party shall submit the following to the other Party and the Neutral:", "": "" }, { "Text": "(a) a copy of all exhibits on which such Party intends to rely in any oral or written presentation to the Neutral;", "": "" }, { "Text": "(b) a list of any witnesses such Party intends to call at the hearing, and a short summary of the anticipated testimony of each witness;", "": "" }, { "Text": "(c) a proposed ruling on each issue to be resolved, together with a request for a specific damage award or other remedy for each issue. The proposed ruling shall not contain any recitation of the facts or any legal arguments, and the proposed remedy shall not include any punitive damages. The proposed ruling and the proposed remedy collectively shall not exceed one (1) page per issue.", "": "" }, { "Text": "(d) a brief in support of such Party's proposed rulings and remedies; provided, that the brief shall not exceed twenty (20) pages. This page limitation shall apply regardless of the number of issues raised in the ADR proceeding.", "": "" }, { "Text": "Except as expressly set forth in subparagraphs 4(a)-4(d), no discovery shall be required or permitted by any means, including depositions, interrogatories, requests for admissions, or production of documents.", "": "" }, { "Text": "5. The hearing shall be conducted on two (2) consecutive days and shall be governed by the following rules:", "": "" }, { "Text": "(a) Each Party shall be entitled to five (5) hours of hearing time to present its case. The Neutral shall determine whether each Party has had the five (5) hours to which it is entitled.", "": "" }, { "Text": "(b) Each Party shall be entitled, but not required, to make an opening statement, to present regular and rebuttal testimony, documents, or other evidence, to cross-examine witnesses, and to make a closing argument. Cross-examination of witnesses shall occur immediately after their direct testimony, and cross-examination time shall be charged against the Party conducting the cross-examination.", "": "" }, { "Text": "(c) The Party initiating the ADR shall begin the hearing and, if it chooses to make an opening statement, shall address therein not only issues it raised but also any issues raised by the responding Party. The responding Party, if it chooses to make an opening statement, also shall address all issues raised in the ADR. Thereafter, the presentation of regular and rebuttal testimony and documents, other evidence, and closing arguments shall proceed in the same sequence.", "": "" }, { "Text": "(d) Except when testifying, witnesses shall be excluded from the hearing until closing arguments.", "": "" }, { "Text": "(e) Settlement negotiations, including any statements made therein, shall not be admissible under any circumstances. Affidavits prepared for purposes of the ADR hearing also shall not be admissible. As to all other matters, the Neutral shall have sole discretion regarding the admissibility of any evidence.", "": "" }, { "Text": "6. Within seven (7) days following completion of the hearing, each Party may submit to the other Party and the Neutral a post-hearing brief in support of its proposed rulings and remedies; provided, that such brief shall not contain or discuss any new evidence and shall not exceed ten (10) pages. This page limitation shall apply regardless of the number of issues raised in the ADR proceeding.", "": "" }, { "Text": "7. The Neutral shall rule on each disputed issue within fourteen (14) days following completion of the hearing. Such ruling shall adopt in its entirety the proposed ruling and remedy of one (1) of the Parties on each disputed issue but may adopt one (1) Party's proposed rulings and remedies on some issues and the other Party's proposed rulings and remedies on other issues. The Neutral shall not issue any written opinion or otherwise explain the basis of the ruling.", "": "" }, { "Text": "8. The Neutral shall be paid a reasonable fee plus expenses. These fees and expenses, along with the reasonable legal fees and expenses of the prevailing Party (including all expert witness fees and expenses), the fees and expenses of a court reporter, and any expenses for a hearing room, shall be paid as follows:", "": "" }, { "Text": "(a) If the Neutral rules in favor of one (1) Party on all disputed issues in the ADR, the losing Party shall pay one hundred percent (100%) of such fees and expenses.", "": "" }, { "Text": "(b) If the Neutral rules in favor of one (1) Party on some issues and the other Party on other issues, the Neutral shall issue with the rulings a written determination as to how such fees and expenses shall be allocated between the Parties. The Neutral shall allocate fees and expenses in a way that bears a reasonable relationship to the outcome of the ADR, with the Party prevailing on more issues, or on issues of greater value or gravity, recovering a relatively larger share of its legal fees and expenses.", "": "" }, { "Text": "9. The rulings of the Neutral and the allocation of fees and expenses shall be binding, non-reviewable, and non-appealable, and may be entered as a final judgment in any court having jurisdiction.", "": "" }, { "Text": "10. Except as provided in paragraph 9 or as required by law, the existence of the Dispute, any settlement negotiations, the ADR proceeding, any submissions (including exhibits, testimony, proposed rulings, and briefs), and the rulings shall be deemed to be Confidential Information of both Parties. The Neutral shall have the authority to impose sanctions for unauthorized disclosure of Confidential Information.", "": "" }, { "Text": "11. All ADR proceedings shall be conducted in the English language.", "": "" }, { "Text": "12. Each Party shall have the right to be represented by counsel in all aspects of any ADR proceeding.", "": "" }, { "Text": "Capsida Biotherapeutics, Inc.", "": "" }, { "Text": "April __, 2021", "": "" }, { "Text": "AbbVie Inc.
1 North Waukegan Road
North Chicago, IL 60064
Attention: Vice Chairman, External Affairs and Chief Legal Officer
Facsimile: +1 847 935 3294", "": "" }, { "Text": "Ladies and Gentlemen:", "": "" }, { "Text": "Reference is hereby made to that certain Convertible Promissory Note in the aggregate principal amount of $10,000,000.00 (as amended from time to time, the \"Note\"), made by Capsida Biotherapeutics, Inc., a Delaware corporation (the \"Company\"), for the benefit of AbbVie Inc. (\"AbbVie\") and dated as of the date hereof. Capitalized terms used but not otherwise defined herein shall have the meanings given to them in the Note.", "": "" }, { "Text": "As a material inducement to AbbVie to purchase the Note, the Company hereby makes the representations and warranties, and agrees to comply with the covenants and agreements, set forth in this letter.", "": "" }, { "Text": "1. Non-Affiliation. From and after the date hereof, the Company will not and will not cause, direct or permit any of its subsidiaries or Affiliates (as defined below) or any of their respective officers, directors, managers, employees, stockholders, members, partners, agents, advisors or representatives (collectively, \"Representatives\") to (a) identify AbbVie or any of its subsidiaries or Affiliates (each, an \"AbbVie Party\" and collectively, the \"AbbVie Parties\") as, or otherwise hold any AbbVie Party out to be an Affiliate of the Company or any of its subsidiaries, except to the extent that such identification is permitted by Section 2 hereof or required by applicable law, by virtue of an AbbVie Party's ownership of a Note or any securities of the Company, and in such case only to the extent so required by law, (b) take any action, or omit to take any action, that causes or that would reasonably be expected to cause any AbbVie Party to be or become an Affiliate of the Company or any of its subsidiaries, other than as set forth in or pursuant to any written agreement executed and delivered by any AbbVie Party (an \"AbbVie Agreement\"), or (c) make, enter into, modify or amend any contract, agreement, instrument, commitment or other arrangement, whether written or oral (a \"Contract\"), other than an AbbVie Agreement, the Note or the Equity Financing Documents (as defined below), that subjects or that would reasonably be expected to subject any AbbVie Party or any of its assets or properties, tangible or intangible, to any lien, encumbrance, claim, restriction or similar obligation or grant or allow on or with respect to any such assets or properties any right of use, exploitation, access or discovery to or in favor of any person or entity other than as set forth or pursuant to an AbbVie Agreement. The Company hereby represents and warrants to AbbVie that as of the date hereof neither it nor any of its subsidiaries is a party to, or any of its assets or properties bound by, any Contract that would violate this Section 1. As used herein, \"Affiliate\" means (i) with respect to any specified person or entity, any other person or entity which, directly or indirectly, controls, is controlled by or is under common control with such other person or entity (with \"control\" and its correlative terms meaning the right or power, directly or indirectly, to cause or restrict the direction of the management and policies of a person or entity whether through the voting of securities, by Contract or otherwise), (ii) an \"affiliate\" as defined in any applicable statute, law, treaty, ordinance, rule, regulation, directive, decree, permit or order and/or (iii) an \"affiliate\" or any similar term as defined in any applicable Contract in a manner or with a meaning consistent with clauses (i) and (ii) above).", "": "" }, { "Text": "2. Publicity. From and after the date hereof, the Company will not, and will not cause, direct or permit any of its Representatives to make or originate any publicity, news release or other announcement, written or oral (a \"Release\"), which mentions any AbbVie Party by name, including, for purposes of clarity, any publicity, news release or other announcement regarding the existence of any arrangement between the Company or any of its subsidiaries and any AbbVie Party or any arrangement between any shareholder of the Company and any AbbVie Party without, in each case, AbbVie's prior written consent (which may be given or withheld in AbbVie's sole discretion), except (a) the Company may disclose AbbVie's status as a securityholder in communications in the ordinary course of business with the Company's securityholders consistent with past practice; provided, that any securityholders receiving such communication shall be informed that such communication is confidential and be directed to maintain the confidentiality of such information, (b) where such Release is, based upon the advice of outside counsel to the Company, required by applicable law; provided, however, that in the event of a legally required Release, the Company will (i) consult with AbbVie to the extent permitted by applicable law under the circumstances with respect to the text or content of such Release and (ii) provide AbbVie with a copy of the Release as promptly as practicable but in no event less than three (3) business days prior to its publication and (c) the Company may issue a press release and disclose information that has already been publicly disclosed pursuant to the terms of Section 11.5 of the Collaboration and Option Agreement, dated as of the date hereof, by and between the Company and AbbVie Global Enterprises Ltd. (the \"Collaboration and Option Agreement\").", "": "" }, { "Text": "3. Transferability. Notwithstanding any provisions to the contrary in the Note, AbbVie shall be entitled to transfer the Note and the rights of AbbVie under this letter to any AbbVie Party (the \"Permitted AbbVie Transferee\"); provided, that the Permitted AbbVie Transferee agrees to be bound by and comply with the requirements set forth in the Note and this letter. Any transfer of the Note (or part thereof) pursuant to this Section 3 shall be effective as of the close of business on the day in which such transfer occurs (including fulfillment of all conditions and requirements with respect thereto). In connection with the conversion of the Note pursuant to the documents executed in connection with a Qualified Financing (the \"Equity Financing Documents\"), AbbVie shall be entitled to transfer any shares into which the Note converts to any AbbVie Party on the same terms and conditions as set forth herein; provided, that the Permitted AbbVie Transferee agrees to be bound by and comply with the terms of the Equity Financing Documents.", "": "" }, { "Text": "4. Information and Inspection Rights.", "": "" }, { "Text": "a. The Company acknowledges that AbbVie Inc., AbbVie's ultimate parent company, is a publicly traded entity that has certain legal reporting obligations to its security holders. Consequently, the Company agrees to provide AbbVie with any information or inspection rights reasonably requested by AbbVie and/or its Affiliates to permit any such Persons to comply with their legal reporting obligations as a publicly traded entity. Furthermore, in addition to, and not in substitution for, any information or related rights granted in the Note (or in the event of a conversion of the Note, the Equity Financing Documents) or otherwise, promptly following a reasonable request by AbbVie, the Company agrees to provide AbbVie with copies of the then current version of the fully executed Note (or in the event of a conversion of the Note, the fully executed Equity Financing Documents), in each case, reflecting all amendments or restatements thereto through such date of request.", "": "" }, { "Text": "b. Without limiting the generality of the foregoing, the Company shall deliver to AbbVie:", "": "" }, { "Text": "i. as soon as practicable, but in any event within one hundred twenty (120) days after the end of each fiscal year of the Company, an unaudited income statement for such fiscal year, an unaudited balance sheet of the Company as of the end of such year and an unaudited statement of cash flows for such year, prepared with generally accepted accounting principles (\"GAAP\") consistently applied, with the exception that no notes need to be attached to such statements, along with a capitalization table showing ownership of equity interests in the Company; provided, that, if the Company engages an external auditor to audit its financial statements, it shall also deliver to AbbVie audited financial statements at the same time they are provided to any of the Company's equity holders;", "": "" }, { "Text": "ii. such financial statements or information as the Company generally provides to its significant investors or other equity holders simultaneously with the delivery thereof to such investors or equity holders; and", "": "" }, { "Text": "iii. such other information relating to the financial condition and the business of the Company as AbbVie may from time to time reasonably request; provided, however, that the Company shall not be obligated pursuant to this Section 4(b) to disclose any information which (x) would adversely affect the attorney-client privilege between the Company and its counsel or (y) would be reasonably likely to result in a conflict of interest that could be detrimental to the Company.", "": "" }, { "Text": "To the extent that the requirements of this Section 4 conflict with any \"Information Rights\" that may exist in the Equity Financing Documents, compliance with such Information Rights (and providing AbbVie with all information provided to other applicable equity holders pursuant to such Information Rights) shall constitute compliance with this Section 4, so long as such Information Rights are substantially similar to those set forth herein.", "": "" }, { "Text": "5. Authority; No contravention. The Company has all necessary corporate power and authority to execute and deliver this letter, and to perform its obligations hereunder. The execution, delivery and performance by the Company of this letter has been approved by the Company's Board of Directors, and shareholders to the extent required, and no other approvals are necessary to authorize the execution, delivery and performance by the Company of this letter. This letter has been duly executed and delivered by the Company and, assuming due authorization, execution and delivery hereof by the other parties hereto, constitutes a legal, valid and binding obligation of the Company, enforceable against the Company in accordance with its terms, except that such enforceability (a) may be limited by bankruptcy, insolvency, fraudulent transfer, reorganization, moratorium and other similar laws of general application affecting or relating to the enforcement of creditors' rights generally and (b) is subject to general principles of equity, whether considered in a proceeding at law or in equity. Neither the execution and delivery of this letter by the Company nor compliance by the Company with any of the terms or provisions hereof, will (i) conflict with or violate any provision of the Company's organizational documents or financing documents, (ii) violate any law, judgment, writ or injunction of any governmental authority applicable to the Company or (iii) violate, conflict with, result in the loss of any benefit under, constitute a default under, result in the termination of or a right of termination or cancellation under, accelerate the performance required by the Company under any loan or credit agreement, note, bond, mortgage, indenture, license, lease, contract or other agreement, instrument or obligation of the Company.", "": "" }, { "Text": "6. Confidentiality. The Company acknowledges that AbbVie and/or its Affiliates may, currently or in the future, be developing information internally, or receiving information from other persons, that is similar to the information disclosed to it by the Company. Nothing will prohibit AbbVie or its Affiliates from developing, manufacturing, marketing, selling, servicing or supporting, or having developed, manufactured, marketed, sold, serviced or supported for it, products, concepts, systems or techniques that are similar to or compete with the products, concepts, systems or techniques contemplated by or embodied in the Company's confidential information; provided, that nothing in this Section 6 shall permit AbbVie or its Affiliates to use, incorporate or reference in any manner the Company's confidential information in relation to such activities. AbbVie will keep confidential and will not disclose, divulge, or use in the conduct of the business of AbbVie or its Affiliates for any purpose (other than for financial reporting purposes and/or to monitor its rights in the Note Purchase Agreement and the Note and this letter) any confidential information obtained from the Company pursuant to the Note and this letter, except such restrictions with respect to the Company's confidential information shall not apply (a) to the disclosure to any employee or director of AbbVie or its Affiliates who is directed to keep such information confidential in accordance with the terms hereof, (b) is known or becomes known to the public in general (other than as a result of a breach of this letter by AbbVie), (c) to disclosure as required by applicable law, regulation, stock exchange rules or legal processes, (d) is or has been made known or disclosed to AbbVie by a third party without a breach of any obligation of confidentiality such third party may have to the Company or (e) to the disclosure to AbbVie's lawyers, contractors, accountants or other advisors who have a need to have access and knowledge of such information. AbbVie may disclose the Note and information disclosed to it pursuant to Section 4 to any prospective purchaser of any Company securities held by AbbVie, if such prospective purchaser agrees to be bound by the confidentiality obligations set forth herein. AbbVie shall be responsible for any breach of this Section 6 by any third party AbbVie shares confidential information with pursuant to this Section 6, and agrees, at its sole expense, to take reasonable measures to restrain such third parties from prohibited or unauthorized disclosure or use of the confidential information covered hereby. For the avoidance of doubt, AbbVie shall be permitted to use information that is independently developed or obtained by AbbVie or any of its Affiliates and that does not use the Company's confidential information or otherwise involve a violation by AbbVie or any third party of any obligation to the Company with respect to its confidential information. Furthermore, neither AbbVie nor its Affiliates shall have any obligation to limit or restrict the assignment of its respective employees or consultants as a result of their having had access to the Company's confidential information, although such assignment shall not otherwise diminish the confidentiality obligations set forth herein. The exchange and protection of confidential information provided by the Company to AbbVie or its Affiliates, or vice versa, pursuant to any separate commercial agreement between the parties or their respective Affiliates, shall not be governed by this letter or the other Equity Financing Documents and shall instead be governed by the terms of such separate commercial agreement or, alternatively, pursuant to a separate non-disclosure agreement between such Persons if executed, provided such agreements do not diminish the protections for confidential information provided in this Section 6.", "": "" }, { "Text": "7. Specific Performance. The Company agrees that irreparable damage may occur if any of the provisions of this letter were not performed in accordance with its specific terms or were otherwise breached. It is accordingly agreed that any AbbVie Party shall be entitled to an injunction or injunctions to prevent breaches of this letter and to enforce specifically the terms and provisions hereof, in addition to any other remedy to which they are entitled hereunder, at law or in equity. AbbVie agrees that irreparable damage may occur if any of the provisions of this letter were not performed in accordance with its specific terms or were otherwise breached. It is accordingly agreed that the Company shall be entitled to seek an injunction or injunctions to prevent breaches of this letter and to seek enforcement specifically of the terms and provisions hereof, in addition to any other remedy to which the Company is entitled hereunder, at law or in equity.", "": "" }, { "Text": "8. Governing Law. The provisions of this letter and its execution, performance or nonperformance, interpretation, termination, construction and all matters based upon, arising out of or related to this letter or the negotiation of this letter (whether in equity, law or statute) shall be governed by and construed in accordance with the laws, both procedural and substantive, of the State of Delaware without regard to its conflicts of law provisions that if applied might permit the application of the laws of another jurisdiction.", "": "" }, { "Text": "9. Successors and Assigns. All of the terms and provisions of this letter shall be binding upon the Company and its successors and permitted assigns and shall inure to the benefit of the AbbVie Parties and each of their respective successors and assigns. All of the terms and provisions of this letter shall be binding upon AbbVie and its successors and permitted assigns and shall inure to the benefit of the Company and its successors and permitted assigns. The Company shall not assign any of its rights, obligations or duties under this letter to any other person or entity (whether directly or indirectly, by operation of law or otherwise), without the prior written consent of AbbVie (which consent may be withheld by AbbVie in its sole and absolute discretion).", "": "" }, { "Text": "10. Remedies and Waivers. No delay or omission on the part of any AbbVie Party in exercising any right, power or remedy provided by law or provided hereunder shall impair such right, power or remedy or operate as a waiver thereof. The single or partial exercise of any right, power or remedy provided by law or provided hereunder shall not preclude any other or further exercise of any other right, power or remedy. The rights, powers and remedies provided hereunder are cumulative and are not exclusive of any rights, powers and remedies provided by law.", "": "" }, { "Text": "11. Amendments. Except as expressly provided herein, neither this agreement nor any term hereof may be amended, waived, discharged or terminated other than by a written instrument referencing this agreement and signed by the Company and AbbVie.", "": "" }, { "Text": "12. No Third-Party Beneficiaries. It is understood and agreed that this letter and the representations, warranties, covenants and agreements made herein are made expressly and solely for the benefit of the Company and the AbbVie Parties, and that no other person or entity shall be entitled or be deemed to be entitled to any benefits or rights hereunder, nor be authorized or entitled to enforce any rights, claims or remedies hereunder or by reason hereof.", "": "" }, { "Text": "13. Severability. If any term or provision of this letter or the application thereof to any person, entity or circumstances shall be held invalid or unenforceable, the remaining terms and provisions hereof and the application of such term or provision to other persons, entities or circumstances shall not be affected thereby.", "": "" }, { "Text": "14. Notice. All notices, requests, consents, claims, demands, waivers and other communications hereunder or in connection herewith shall be delivered in accordance with the notice provisions in the Collaboration and Option Agreement.", "": "" }, { "Text": "15. Termination. Unless otherwise terminated earlier pursuant to the provisions hereof, this letter shall terminate upon the earliest to occur of (i) the closing of an initial underwritten public offering of the Company's equity securities pursuant to an effective registration statement, (ii) the merger of the Company with or into another entity or a sale of all or substantially all of the assets of the Company and (iii) the date that the AbbVie Parties cease to own any securities in the Company. Notwithstanding the foregoing, Sections 1, 2, 6 and this Section 15, and the confidentiality obligations referenced herein, shall survive the termination of this letter.", "": "" }, { "Text": "[Remainder of Page Intentionally Left Blank]", "": "" }, { "Text": "IN WITNESS WHEREOF, the Company has caused its duly authorized officer to execute this letter as of the date first above written.

Capsida Biotherapeutics, Inc.

By: _____________________________________
Name:  
Title:", "": "" }, { "Text": "ACKNOWLEDGED AND ACCEPTED:

ABBVIE INC.

By:  
Name:  
Title:", "": "" }, { "Text": "ECUTION VERSION", "": "" }, { "Text": "Collaboration and License Option Agreement", "": "" }, { "Text": "Between", "": "" }, { "Text": "Cugene, Inc.", "": "" }, { "Text": "and", "": "" }, { "Text": "AbbVie Global Enterprises Ltd.", "": "" }, { "Text": "Dated as of May 6, 2022", "": "" }, { "Text": "TABLE OF CONTENTS", "": "" }, { "Text": "ARTICLE 1 DEFINITIONS........................................................................................................... 1", "": "" }, { "Text": "ARTICLE 2 INITIAL DEVELOPMENT .................................................................................... 26", "": "" }, { "Text": "2.1. Initial Development Plan and Budget ................................................................... 26", "": "" }, { "Text": "2.2. Diligence ............................................................................................................... 26", "": "" }, { "Text": "2.3. Performance of Initial Development and Regulatory Activities........................... 27", "": "" }, { "Text": "2.4. Information and Reports ....................................................................................... 29", "": "" }, { "Text": "2.5. Data Packages ....................................................................................................... 30", "": "" }, { "Text": "2.6. Expenses ............................................................................................................... 32", "": "" }, { "Text": "ARTICLE 3 LICENSE OPTION.................................................................................................. 32", "": "" }, { "Text": "3.1. License Option ...................................................................................................... 32", "": "" }, { "Text": "3.2. License Option Exercise ....................................................................................... 32", "": "" }, { "Text": "3.3. Licensed Therapeutic and Licensed Product Responsibility ................................ 33", "": "" }, { "Text": "3.4. Additional Cugene Obligations............................................................................. 34", "": "" }, { "Text": "3.5. Termination of License Option............................................................................. 36", "": "" }, { "Text": "ARTICLE 4 GRANT OF RIGHTS; EXCLUSIVITY.................................................................. 36", "": "" }, { "Text": "4.1. Grants to AbbVie .................................................................................................. 36", "": "" }, { "Text": "4.2. Grants to Cugene................................................................................................... 36", "": "" }, { "Text": "4.3. Sublicenses............................................................................................................ 36", "": "" }, { "Text": "4.4. No Implied Licenses ............................................................................................. 37", "": "" }, { "Text": "4.5. Confirmatory Patent License ................................................................................ 37", "": "" }, { "Text": "4.6. Exclusivity ............................................................................................................ 37", "": "" }, { "Text": "ARTICLE 5 DEVELOPMENT AND COMMERCIALIZATION BY ABBVIE........................ 38", "": "" }, { "Text": "5.1. In General.............................................................................................................. 38", "": "" }, { "Text": "5.2. Diligence ............................................................................................................... 38", "": "" }, { "Text": "5.3. Manufacturing Technology Transfer .................................................................... 38", "": "" }, { "Text": "5.4. Subcontracting; Distributors ................................................................................. 40", "": "" }, { "Text": "5.5. Records; Development and Commercialization Reports...................................... 41", "": "" }, { "Text": "5.6. Regulatory Activities ............................................................................................ 42", "": "" }, { "Text": "5.7. Adverse Event and Safety Information Agreement .............................................. 42", "": "" }, { "Text": "ARTICLE 6 COLLABORATION MANAGEMENT.................................................................. 42", "": "" }, { "Text": "6.1. Joint Governance Committee................................................................................ 42", "": "" }, { "Text": "6.2. General Provisions Applicable to the JGC ........................................................... 44", "": "" }, { "Text": "6.3. Working Groups.................................................................................................... 46", "": "" }, { "Text": "6.4. Alliance Managers. ............................................................................................... 46", "": "" }, { "Text": "ARTICLE 7 PAYMENTS AND RECORDS............................................................................... 47", "": "" }, { "Text": "7.1. Upfront Payment................................................................................................... 47", "": "" }, { "Text": "7.2. License Option Exercise Payment ........................................................................ 47", "": "" }, { "Text": "7.3. Development Milestone Events ............................................................................ 47", "": "" }, { "Text": "7.4. Sales Milestone Events ......................................................................................... 49", "": "" }, { "Text": "7.5. Royalties ............................................................................................................... 49", "": "" }, { "Text": "7.6. Estimated Sales Levels ......................................................................................... 52", "": "" }, { "Text": "7.7. Royalty Payments and Reports ............................................................................. 52", "": "" }, { "Text": "7.8. Mode of Payment.................................................................................................. 52", "": "" }, { "Text": "7.9. Taxes. .................................................................................................................... 52", "": "" }, { "Text": "7.10. Interest on Late Payments..................................................................................... 54", "": "" }, { "Text": "7.11. Financial Records.................................................................................................. 54", "": "" }, { "Text": "7.12. Audit ..................................................................................................................... 54", "": "" }, { "Text": "7.13. Right to Offset....................................................................................................... 55", "": "" }, { "Text": "7.14. Diagnostic and Veterinary Products ..................................................................... 55", "": "" }, { "Text": "7.15. No Other Compensation ....................................................................................... 55", "": "" }, { "Text": "7.16. No Limitation........................................................................................................ 55", "": "" }, { "Text": "7.17. Financial Obligations Under WuXi Agreements.................................................. 55", "": "" }, { "Text": "ARTICLE 8 INTELLECTUAL PROPERTY .............................................................................. 55", "": "" }, { "Text": "8.1. Ownership of Intellectual Property....................................................................... 55", "": "" }, { "Text": "8.2. Prosecution and Maintenance of Patents .............................................................. 57", "": "" }, { "Text": "8.3. Enforcement of Patents ......................................................................................... 62", "": "" }, { "Text": "8.4. Infringement Claims by Third Parties................................................................... 67", "": "" }, { "Text": "8.5. Invalidity or Unenforceability Defenses or Actions ............................................. 68", "": "" }, { "Text": "8.6. Third Party Licenses and Patents.......................................................................... 71", "": "" }, { "Text": "8.7. Product Trademarks .............................................................................................. 72", "": "" }, { "Text": "8.8. Inventor's Remuneration ...................................................................................... 73", "": "" }, { "Text": "ARTICLE 9 CONFIDENTIALITY AND NON-DISCLOSURE ................................................ 74", "": "" }, { "Text": "9.1. Confidentiality Obligations................................................................................... 74", "": "" }, { "Text": "9.2. Permitted Disclosures ........................................................................................... 75", "": "" }, { "Text": "9.3. Additional Permitted Disclosures and Use by AbbVie......................................... 76", "": "" }, { "Text": "9.4. Additional Permitted Disclosures and Use by Cugene ......................................... 76", "": "" }, { "Text": "9.5. Use of Name ......................................................................................................... 77", "": "" }, { "Text": "9.6. Public Announcements ......................................................................................... 77", "": "" }, { "Text": "9.7. Publications........................................................................................................... 78", "": "" }, { "Text": "9.8. Return of Confidential Information ...................................................................... 79", "": "" }, { "Text": "ARTICLE 10 REPRESENTATIONS AND WARRANTIES...................................................... 79", "": "" }, { "Text": "10.1. Mutual Representations and Warranties ............................................................... 79", "": "" }, { "Text": "10.2. Additional Representations, Warranties and Covenants of Cugene ..................... 79", "": "" }, { "Text": "10.3. Additional Covenants of Cugene .......................................................................... 85", "": "" }, { "Text": "10.4. Additional Representations, Warranties and Covenants of AbbVie..................... 87", "": "" }, { "Text": "10.5. DISCLAIMER OF WARRANTIES..................................................................... 88", "": "" }, { "Text": "10.6. Anti-Bribery and Anti-Corruption Compliance.................................................... 88", "": "" }, { "Text": "ARTICLE 11 INDEMNITY......................................................................................................... 88", "": "" }, { "Text": "11.1. Indemnification of Cugene ................................................................................... 88", "": "" }, { "Text": "11.2. Indemnification of AbbVie ................................................................................... 89", "": "" }, { "Text": "11.3. Indemnification Procedures .................................................................................. 89", "": "" }, { "Text": "11.4. Special, Indirect and Other Losses........................................................................ 92", "": "" }, { "Text": "11.5. Insurance ............................................................................................................... 92", "": "" }, { "Text": "ARTICLE 12 TERM AND TERMINATION .............................................................................. 93", "": "" }, { "Text": "12.1. Term and Expiration ............................................................................................. 93", "": "" }, { "Text": "12.2. Termination........................................................................................................... 93", "": "" }, { "Text": "12.3. Rights in Bankruptcy ............................................................................................ 95", "": "" }, { "Text": "12.4. Consequences of Termination............................................................................... 96", "": "" }, { "Text": "12.5. Transition Agreement. .......................................................................................... 99", "": "" }, { "Text": "12.6. Reverse Royalty .................................................................................................. 102", "": "" }, { "Text": "12.7. AbbVie Rights in Lieu of Termination............................................................... 102", "": "" }, { "Text": "12.8. Remedies............................................................................................................. 103", "": "" }, { "Text": "12.9. Accrued Rights; Surviving Obligations .............................................................. 103", "": "" }, { "Text": "ARTICLE 13 MISCELLANEOUS ............................................................................................ 104", "": "" }, { "Text": "13.1. Force Majeure ..................................................................................................... 104", "": "" }, { "Text": "13.2. Export Control .................................................................................................... 104", "": "" }, { "Text": "13.3. Assignment ......................................................................................................... 104", "": "" }, { "Text": "13.4. Severability ......................................................................................................... 106", "": "" }, { "Text": "13.5. Dispute Resolution.............................................................................................. 106", "": "" }, { "Text": "13.6. Governing Law ................................................................................................... 107", "": "" }, { "Text": "13.7. Notices ................................................................................................................ 107", "": "" }, { "Text": "13.8. Entire Agreement; Amendments......................................................................... 108", "": "" }, { "Text": "13.9. English Language................................................................................................ 108", "": "" }, { "Text": "13.10. Equitable Relief .................................................................................................. 108", "": "" }, { "Text": "13.11. Waiver and Non-Exclusion of Remedies............................................................ 109", "": "" }, { "Text": "13.12. No Benefit to Third Parties ................................................................................. 109", "": "" }, { "Text": "13.13. Further Assurance ............................................................................................... 109", "": "" }, { "Text": "13.14. Relationship of the Parties .................................................................................. 109", "": "" }, { "Text": "13.15. References........................................................................................................... 110", "": "" }, { "Text": "13.16. Construction........................................................................................................ 110", "": "" }, { "Text": "13.17. Performance by Affiliates ................................................................................... 110", "": "" }, { "Text": "13.18. Change in Control of Cugene ............................................................................. 110", "": "" }, { "Text": "13.19. Counterparts........................................................................................................ 111", "": "" }, { "Text": "Schedules", "": "" }, { "Text": "Schedule 1.54 Corporate Names", "": "" }, { "Text": "Schedule 1.94 Existing Patents Schedule", "": "" }, { "Text": "Schedule 1.116 In-License Schedule", "": "" }, { "Text": "Schedule 1.123 Indications", "": "" }, { "Text": "Schedule 1.126 Initial Development Plan and Budget", "": "" }, { "Text": "Schedule 2.3.4 Permitted Entities", "": "" }, { "Text": "Schedule 7.5 Sample Royalty Calculation", "": "" }, { "Text": "Schedule 9.6 Form of Joint Press Release", "": "" }, { "Text": "Schedule 10.2.1(c) Cugene Patents", "": "" }, { "Text": "Schedule 13.5.3 ADR Procedures", "": "" }, { "Text": "COLLABORATION AND LICENSE OPTION AGREEMENT", "": "" }, { "Text": "This Collaboration and License Option Agreement (this \"Agreement\") is made and entered into as of May 6, 2022 (the \"Effective Date\") by and between Cugene, Inc., a Delaware corporation (\"Cugene\"), and AbbVie Global Enterprises Ltd., a Bermudian limited company (\"AbbVie\"). Cugene and AbbVie are sometimes referred to herein individually as a \"Party\" and collectively as the \"Parties.", "": "" }, { "Text": "RECITALS", "": "" }, { "Text": "WHEREAS, Cugene owns and controls certain intellectual property rights with respect to certain IL-2 (as defined below) muteins in the Territory (as defined below); and", "": "" }, { "Text": "WHEREAS, the Parties wish for Cugene to perform certain Development (as defined below) activities with respect to such muteins; and", "": "" }, { "Text": "WHEREAS, Cugene wishes to grant to AbbVie, and AbbVie wishes to obtain, an option to take an exclusive license under such intellectual property rights to Exploit (as defined below) Licensed Therapeutics (as defined below) and Licensed Products (as defined below) in the Field (as defined below) in the Territory, in accordance with the terms and conditions set forth below.", "": "" }, { "Text": "NOW, THEREFORE, in consideration of the premises and the mutual promises and conditions set forth herein and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, do hereby agree as follows:", "": "" }, { "Text": "ARTICLE 1 DEFINITIONS", "": "" }, { "Text": "Unless otherwise specifically provided herein, the following terms shall have the following meanings:", "": "" }, { "Text": "1.1. \"418 Patent\" means any Cugene Patent related to the Excluded Compound, including WO/2020/252418.", "": "" }, { "Text": "1.2. \"AbbVie\" has the meaning set forth in the preamble hereto.", "": "" }, { "Text": "1.3. \"AbbVie Grantback Agreement Know-How\" means all Information Controlled by AbbVie or its Affiliates during the Term or as of the effective date of the applicable termination of this Agreement that was conceived, discovered, developed or otherwise made by or on behalf of AbbVie (or its Affiliates or its or their Sublicensees) under or in connection with this Agreement or the MTA that is not generally known and is necessary or reasonably useful for the Exploitation of any Reversion Product as of such effective date of termination.", "": "" }, { "Text": "1.4. \"AbbVie Grantback Agreement Patent\" means any Patent Controlled by AbbVie or its Affiliates during the Term or as of the effective date of the applicable termination of this Agreement that was conceived, discovered, developed or otherwise made by or on behalf of AbbVie (or its Affiliates or its or their Sublicensees) under or in connection with this Agreement or the MTA that is necessary or reasonably useful for the Exploitation of any Reversion Product as of such effective date of termination.", "": "" }, { "Text": "1.5. \"AbbVie Grantback Background Know-How\" means all Information Controlled by AbbVie or its Affiliates as of the effective date of the applicable termination of this Agreement, other than AbbVie Grantback Agreement Know-How, that is not generally known and is necessary for the Exploitation of any Reversion Product as of such effective date of termination.", "": "" }, { "Text": "1.6. \"AbbVie Grantback Background Patent\" means any Patent Controlled by AbbVie or its Affiliates as of the effective date of the applicable termination of this Agreement, other than AbbVie Grantback Agreement Patents, that is necessary for the Exploitation of any Reversion Product as of such effective date of termination.", "": "" }, { "Text": "1.7. \"AbbVie Grantback Know-How\" means the AbbVie Grantback Agreement Know-How and AbbVie Grantback Background Know-How.", "": "" }, { "Text": "1.8. \"AbbVie Grantback Patents\" means the AbbVie Grantback Agreement Patents and AbbVie Grantback Background Patents.", "": "" }, { "Text": "1.9. \"AbbVie Indemnitees\" has the meaning set forth in Section 11.2.", "": "" }, { "Text": "1.10. \"AbbVie Liquid Formulation\" means any formulation Developed by or on behalf of AbbVie during the Term specifically for a Licensed Product that is liquid above 0°C. For clarity, AbbVie Liquid Formulation does not include the liquid formulation for the Licensed Product described in the Initial Development Plan and Budget as of the Effective Date.", "": "" }, { "Text": "1.11. \"AbbVie Patents\" means all Patents owned or Controlled, that are conceived, discovered, developed or otherwise made, by or on behalf of AbbVie under this Agreement (other than the Joint Patents). For clarity, AbbVie Patents shall not include Cugene Patents.", "": "" }, { "Text": "1.12. \"Acceptance\" means, with respect to a BLA, receipt of written notice from the FDA indicating that such BLA has been accepted for filing and further FDA review.", "": "" }, { "Text": "1.13. \"Accounting Standards\" means, with respect to a Party or its Affiliates or its or their (sub)licensees, United States generally accepted accounting principles, consistently applied.", "": "" }, { "Text": "1.14. \"Acquirer IP\" has the meaning set forth in Section 13.3.2.", "": "" }, { "Text": "1.15. \"Acquiring Entities\" has the meaning set forth in Section 13.3.2.", "": "" }, { "Text": "1.16. \"Acquisition\" means, with respect to a Party, a merger, acquisition (whether of all of the stock or all or substantially all of the assets of a Person or any operating or business division of a Person) or similar transaction by or with the Party (or any controlling Affiliate), other than a Change in Control of the Party.", "": "" }, { "Text": "1.17. \"Acquisition Party\" has the meaning set forth in Section 13.3.2.", "": "" }, { "Text": "1.18. \"Acquisition Transaction\" has the meaning set forth in Section 13.3.2.", "": "" }, { "Text": "1.19. \"ADR\" has the meaning set forth in Section 13.5.1.", "": "" }, { "Text": "1.20. \"Adverse Event and Safety Information Agreement\" has the meaning set forth in Section 5.7.", "": "" }, { "Text": "1.21. \"Affiliate\" means, with respect to a Party, any Person that, directly or indirectly, through one or more intermediaries, controls, is controlled by or is under common control with such Party. For purposes of this definition, \"control\" and, with correlative meanings, the terms \"controlled by\" and \"under common control with\" mean: (a) the possession, directly or indirectly, of the power to direct the management or policies of a Person, whether through the ownership of voting securities, by contract relating to voting rights or corporate governance or otherwise; or (b) the ownership, directly or indirectly, of more than 50% of the voting securities or other ownership interest of a Person (or, with respect to a limited partnership or other similar entity, its general partner or controlling entity).", "": "" }, { "Text": "1.22. \"Agreement\" has the meaning set forth in the preamble hereto.", "": "" }, { "Text": "1.23. \"Alliance Managers\" has the meaning set forth in Section 6.4.", "": "" }, { "Text": "1.24. \"Applicable Law\" means applicable laws, rules and regulations, including any rules, regulations, regulatory guidelines or other requirements of Regulatory Authorities, that may be in effect from time to time.", "": "" }, { "Text": "1.25. \"Assay\" means the in vitro pSTAT5 human PBMC assay, the protocol of which is set forth in the Side Letter.", "": "" }, { "Text": "1.26. \"Auditor\" has the meaning set forth in Section 7.12.2.", "": "" }, { "Text": "1.27. \"Biosimilar Application\" has the meaning set forth in Section 8.3.7.", "": "" }, { "Text": "1.28. \"Biosimilar Product\" means, with respect to a Licensed Product in a country or other jurisdiction, a biological product that (a) is highly similar to such Licensed Product (as the reference product with respect thereto) notwithstanding minor differences in clinically inactive components; (b) has no clinically meaningful differences with regard to such Licensed Product (as the reference product with respect thereto) in terms of safety, purity, or potency, as determined by Applicable Law or any applicable Regulatory Authority; (c) is approved under 42 USC § 262(k)(4) for at least one of the same uses as such Licensed Product (as the reference product with respect thereto) in the United States or a regulatory regime under a Regulatory Authority for the approval or licensure of biosimilar biological products in another country or other jurisdiction; and (d) is marketed or sold by a Third Party (other than under a license or authorization by a Party, its Affiliate or Sublicensee with respect to Commercializing a Licensed Product) who did not purchase such biological product in a chain of distribution that included AbbVie, or its Affiliates or its or their Sublicensees.", "": "" }, { "Text": "1.29. \"Bispecific Patent\" means any Cugene Patent related to bifunctional or multi-functional fusion molecules comprising an IL-2 variant, including WO/2020/252421.", "": "" }, { "Text": "1.30. \"BLA\" has the meaning set forth in the definition of \"Drug Approval Application\".", "": "" }, { "Text": "1.31. \"Board of Directors\" has the meaning set forth in the definition of \"Change in Control\".", "": "" }, { "Text": "1.32. \"Breaching Party\" has the meaning set forth in Section 12.2.1(a).", "": "" }, { "Text": "1.33. \"Bring Down Date\" has the meaning set forth in Section 10.2.2(c).", "": "" }, { "Text": "1.34. \"Bring Down Request\" has the meaning set forth in Section 10.2.2(a).", "": "" }, { "Text": "1.35. \"Bring Down Request Date\" has the meaning set forth in Section 10.2.2(a).", "": "" }, { "Text": "1.36. \"Business Day\" means a day other than a Saturday or Sunday on which banking institutions in Chicago, Illinois, and Boston, Massachusetts, are open for business.", "": "" }, { "Text": "1.37. \"Calendar Quarter\" means each successive period of three calendar months commencing on January 1, April 1, July 1 or October 1, except that the first Calendar Quarter of the Term shall commence on the Effective Date and end on the day immediately prior to the first to occur of January 1, April 1, July 1 and October 1 after the Effective Date and the last Calendar Quarter shall end on the last day of the Term.", "": "" }, { "Text": "1.38. \"Calendar Year\" means each successive period of 12 calendar months commencing on January 1 and ending on December 31, except that the first Calendar Year of the Term shall commence on the Effective Date and end on December 31 of the year in which the Effective Date occurs and the last Calendar Year of the Term shall commence on January 1 of the year in which the Term ends and end on the last day of the Term.", "": "" }, { "Text": "1.39. \"CD4\" means the CD4 membrane glycoprotein of T lymphocytes, encoded by the gene with NCBI gene ID: 920.", "": "" }, { "Text": "1.40. \"CD4+Treg\" means CD4+CD25+FOXP3+ T cells.", "": "" }, { "Text": "1.41. \"CD8\" means the CD8 membrane glycoprotein on cytotoxic T lymphocytes, encoded by the gene with NCBI gene ID: 925.", "": "" }, { "Text": "1.42. \"Change in Control\" means, with respect to a Party, that any of the following occurs after the Effective Date:", "": "" }, { "Text": "1.42.1. any \"person\" or \"group\" (as such terms are defined below) acquires or becomes the \"beneficial owner\" (as defined below), directly or indirectly, of (a) shares of capital stock or other interests (including partnership interests) of such Party (or any controlling Affiliate of such Party) then outstanding and normally entitled (without regard to the occurrence of any contingency) to vote in the election of the directors, managers or similar supervisory positions (\"Voting Stock\") of such Party (or any controlling Affiliate of such Party) representing 50% or more of the total voting power of all outstanding classes of Voting Stock of such Party (or any controlling Affiliate of such Party) or (b) the power to elect a majority of the members of the Party's (or any such Party's controlling Affiliate's) board of directors, or similar governing body (\"Board of Directors\"); the Parties acknowledge that in the case of certain entities organized under the laws of certain countries or other jurisdictions outside of the United States, the maximum percentage ownership permitted by law for a foreign investor may be less than 50%, and that in such case such lower percentage shall be substituted in the preceding sentence, provided that such foreign investor has the power to direct the management or policies of such entity; or", "": "" }, { "Text": "1.42.2. such Party (or any controlling Affiliate of such Party) enters into a merger, consolidation or similar transaction with another Person (whether or not such Party (or any controlling Affiliate of such Party) is the surviving entity) and as a result of such merger, consolidation or similar transaction (a) the members of the Board of Directors of such Party (or any controlling Affiliate of such Party) immediately prior to such transaction constitute less than a majority of the members of the Board of Directors of such Party (or any controlling Affiliate of such Party) or such surviving Person immediately following such transaction or (b) the Persons that beneficially owned, directly or indirectly, the shares of Voting Stock of such Party (or any controlling Affiliate of such Party) immediately prior to such transaction cease to beneficially own, directly or indirectly, shares of Voting Stock of such Party (or any controlling Affiliate of such Party) representing at least a majority of the total voting power of all outstanding classes of Voting Stock of the surviving Person in substantially the same proportions as their ownership of Voting Stock of such Party (or any controlling Affiliate of such Party) immediately prior to such transaction; or", "": "" }, { "Text": "1.42.3. such Party (or any controlling Affiliate of such Party) sells or transfers to any Third Party, in one or more related transactions, properties or assets representing all or substantially all of such Party's (or any such Party's controlling Affiliate's) consolidated total assets to which this Agreement relates; or", "": "" }, { "Text": "1.42.4. the holders of capital stock of such Party (or any controlling Affiliate of such Party) approve a plan or proposal for the liquidation or dissolution of such Party (or any controlling Affiliate of such Party).", "": "" }, { "Text": "For the purpose of this definition of Change in Control, (a) \"person\" and \"group\" have the meanings given such terms under Section 13(d) and 14(d) of the United States Securities Exchange Act of 1934 and the term \"group\" includes any group acting for the purpose of acquiring, holding or disposing of securities within the meaning of Rule 13d-5(b)(1) under such Act; (b) a \"beneficial owner\" shall be determined in accordance with Rule 13d-3 under such Act; and (c) the terms \"beneficially owned\" and \"beneficially own\" shall have meanings correlative to that of \"beneficial owner.\" Notwithstanding anything to the contrary in this Section 1.42, any transaction or series of transactions effected for the primary purpose of financing the operations of the application entity (including the issuance or sale of securities for financing purpose) without resulting in such entity being controlled by (as defined in the Section 1.21) a pharmaceutical, biotechnology, medical device or diagnostic company, including any Affiliate or any venture capital subsidiary or division of a pharmaceutical, biotechnology, medical device or diagnostic company, or changing the form or jurisdiction of organization of such entity will not be deemed a \"Change in Control\" for purposes of this Agreement.", "": "" }, { "Text": "1.43. \"Clinical Studies\" means any tests and studies in human subjects that are required or permitted by Applicable Law to obtain or maintain any Regulatory Approval for, or to support the pricing, reimbursement or use of, a Licensed Product, including tests or studies that are intended to expand the Product Labeling for a Licensed Product.", "": "" }, { "Text": "1.44. \"CMC Activities\" means, with respect to a Licensed Therapeutic or Licensed Product, all Manufacturing activities (including the generation of all CMC Data) necessary to support the development or commercialization of such Licensed Therapeutic or Licensed Product, as applicable, at the applicable stage of development, including formulation, process development, process qualification and validation, scale-up, analytic development, product characterization, stability testing, quality assurance and quality control.", "": "" }, { "Text": "1.45. \"CMC Data\" means the chemistry, manufacturing and controls data for each Licensed Therapeutic or Licensed Product, as applicable, required by Applicable Law to be included or referenced in, or that otherwise supports, an application for Regulatory Approval.", "": "" }, { "Text": "1.46. \"Combination Product\" means a Licensed Product that comprises or contains one or more Licensed Therapeutics as an active ingredient together with one or more other active ingredients (each, an \"Other Active\"), whether in the same or different formulations, and is sold either as a fixed dose or as separate doses as one product.", "": "" }, { "Text": "1.47. \"Commercialization\" means any and all activities directed to the preparation for sale of, offering for sale of or sale of a Licensed Product, including activities related to marketing, promoting, distributing, importing and exporting such Licensed Product, and interacting with Regulatory Authorities regarding any of the foregoing. When used as a verb, \"Commercialize\" means to engage in Commercialization and \"Commercialized\" has a corresponding meaning.", "": "" }, { "Text": "1.48. \"Commercially Reasonable Efforts\" means, with respect to the performance of Development, Commercialization or Manufacturing or other Exploitation activities with respect to a Licensed Therapeutic or Licensed Product by a Party, the carrying out of such activities using efforts and resources comparable to the efforts and resources commonly used by a similarly resourced and similarly situated company in the biopharmaceutical industry for a compound or product owned by such company or to which such company has exclusive right, which compound or product is of similar market potential at a similar stage in development or product life, taking into account all scientific, commercial, and other relevant factors, including issues of safety and efficacy, expected and actual cost and time to develop, expected and actual profitability (excluding, solely for purposes of determining Commercially Reasonable Efforts, royalties and other payments required hereunder), expected and actual competitiveness of alternative products (including generic or biosimilar products), the nature and extent of market exclusivity (including patent coverage and regulatory exclusivity), the expected likelihood of regulatory approval, and the expected and actual reimbursability and pricing.", "": "" }, { "Text": "1.49. \"Competing Product\" means (a) any Licensed Therapeutic in the Field in the Territory or (b) any other mutein, antibody, compound, molecule or other therapeutic that satisfies the Immunology Test. Notwithstanding the foregoing, Competing Products do not include the Cugene Existing P19/126 Oncology Compounds.", "": "" }, { "Text": "1.50. \"Confidential Information\" has the meaning set forth in Section 9.1.", "": "" }, { "Text": "1.51. \"Control\" means, subject to Section 13.3.2, with respect to a Party and any item of Information, Regulatory Documentation, material, Patent or other intellectual property right, possession by such Party of the right, whether directly or indirectly and whether by ownership, license or otherwise (other than by operation of the license and other grants in Section 4.1 or Section 4.2), to grant a license, sublicense or other right (including the right to reference Regulatory Documentation) to or under such Information, Regulatory Documentation, material, Patent or other intellectual property right as provided for herein without violating the terms of any agreement or arrangement with any Third Party or, subject to Section 8.6.1, creating a payment obligation upon such Party (unless such Party agrees herein to bear the applicable payments arising under the applicable Third Party agreement).", "": "" }, { "Text": "1.52. \"Convicted Entity\" has the meaning set forth in Section 10.2.1(u)(4).", "": "" }, { "Text": "1.53. \"Convicted Individual\" has the meaning set forth in Section 10.2.1(u)(4).", "": "" }, { "Text": "1.54. \"Corporate Names\" means the Trademarks and logos identified on Schedule 1.54 and such other replacement corporate names and logos as Cugene may use from time to time.", "": "" }, { "Text": "1.55. \"Cover\" means, when referring to a Licensed Product or other product, (a) with respect to a Patent, that, in the absence of a license granted to a Person under an issued claim included in such Patent, the practice by such Person of a specified activity with respect to such Licensed Product or product would infringe such claim, or (b) with respect to an patent application, that, in the absence of a license granted to a Person under a claim included in such application, the practice by such Person of a specified activity with respect to such Licensed Product or product would infringe such claim if such patent application were to issue as a patent.", "": "" }, { "Text": "1.56. \"CREATE Act\" has the meaning set forth in Section 8.2.6.", "": "" }, { "Text": "1.57. \"CUG252\" means an Fc-fusion protein that comprises the Licensed IL-2 Mutein, the amino acid sequence of which fusion protein is set forth in the Side Letter.", "": "" }, { "Text": "1.58. \"Cugene\" has the meaning set forth in the preamble hereto.", "": "" }, { "Text": "1.59. \"Cugene Existing P19/126 Oncology Compound\" means any compound that is or comprises an IL-2 Mutein with an internal Cugene reference ID number P-1247 or P-1248.", "": "" }, { "Text": "1.60. \"Cugene Indemnitees\" has the meaning set forth in Section 11.1.", "": "" }, { "Text": "1.61. \"Cugene IP\" means the Cugene Know-How, Cugene Patents and Cugene Trademarks.", "": "" }, { "Text": "1.62. \"Cugene Know-How\" means all Information Controlled by Cugene or any of its Affiliates as of the Effective Date or at any time during the Term that is not generally known and is necessary or reasonably useful to Exploit a Licensed Therapeutic or Licensed Product in the Field in the Territory, but excluding any (a) Joint Know-How and (b) Information to the extent published in Cugene Patents. The Cugene Know-How includes all Study Data.", "": "" }, { "Text": "1.63. \"Cugene Patent\" means all Patents Controlled by Cugene or any of its Affiliates as of the Effective Date or at any time during the Term that are necessary or reasonably useful (or, with respect to patent applications, would be necessary or reasonably useful if such patent applications were to issue as patents) to Exploit a Licensed Therapeutic or Licensed Product in the Field in the Territory, but excluding any Joint Patents. Such Patents existing as of the Effective Date are set forth on the Existing Patents Schedule. For clarity, the Cugene Patents include the Bispecific Patents and the Vitokine Patents.", "": "" }, { "Text": "1.64. \"Cugene Trademarks\" means any Trademarks Controlled by Cugene or any of its Affiliates that are used in connection with any Licensed Therapeutic or Licensed Product as of the License Option Effective Date, excluding Cugene's Corporate Names.", "": "" }, { "Text": "1.65. \"Data Breach\" has the meaning set forth in Section 10.3.4.", "": "" }, { "Text": "1.66. \"Data Package\" means an Early Exercise Data Package, Preliminary Final Data Package or the Final Data Package.", "": "" }, { "Text": "1.67. \"Data Protection Laws\" means all Applicable Law relating to the privacy, Processing and security of Personal Data.", "": "" }, { "Text": "1.68. \"Debarred Entity\" has the meaning set forth in Section 10.2.1(u)(2).", "": "" }, { "Text": "1.69. \"Debarred Individual\" has the meaning set forth in Section 10.2.1(u)(1).", "": "" }, { "Text": "1.70. \"Defense Proceeding\" has the meaning set forth in Section 8.2.1(a).", "": "" }, { "Text": "1.71. \"Development\" means all activities related to research, pre-clinical and other non-clinical testing, test method development and stability testing, toxicology, formulation, process development, manufacturing scale-up, qualification and validation, quality assurance/quality control, CMC Activities, Clinical Studies (including Manufacturing in support thereof), statistical analysis and report writing, the preparation and submission of INDs and Drug Approval Applications, regulatory affairs with respect to the foregoing and all other activities necessary or reasonably useful or otherwise requested or required by a Regulatory Authority as a condition or in support of obtaining or maintaining a Regulatory Approval. When used as a verb, \"Develop\" means to engage in Development. For clarity, Development shall include any submissions and activities required in support thereof, including those required by Applicable Law or a Regulatory Authority as a condition or in support of obtaining a pricing or reimbursement approval for an approved Licensed Product.", "": "" }, { "Text": "1.72. \"Development Milestone Event\" has the meaning set forth in Section 7.3.", "": "" }, { "Text": "1.73. \"Development Milestone Payment\" has the meaning set forth in Section 7.3.", "": "" }, { "Text": "1.74. \"Different Licensed Product\" has the meaning set forth in Section 7.3.", "": "" }, { "Text": "1.75. \"Disclosing Party\" has the meaning set forth in Section 9.1.1.", "": "" }, { "Text": "1.76. \"Dispute\" has the meaning set forth in Section 13.5.", "": "" }, { "Text": "1.77. \"Distributor\" means any Person appointed by AbbVie or any of its Affiliates or its or their Sublicensees to distribute, market and sell Licensed Product with or without packaging rights, in one or more countries or other jurisdictions in the Territory, in circumstances where such Person purchases its requirements of Licensed Product from AbbVie or its Affiliates or its or their Sublicensees but does not otherwise make any royalty or other payment to AbbVie or its Affiliates or its or their Sublicensees with respect to its intellectual property rights with respect to such Licensed Product.", "": "" }, { "Text": "1.78. \"DOJ\" means the United States Department of Justice.", "": "" }, { "Text": "1.79. \"Dollars\" or \"$\" means United States Dollars.", "": "" }, { "Text": "1.80. \"DRC\" means, with respect any Clinical Study conducted under the Initial Development Plan and Budget, the data review committee or data monitoring committee established in accordance with the Initial Development Plan and Budget and Applicable Law.", "": "" }, { "Text": "1.81. \"Drug Approval Application\" means a Biologics License Application as defined in the FFDCA (a \"BLA\") or any corresponding foreign application in the Territory, including, with respect to the European Union, a marketing authorization application filed with the EMA pursuant to the centralized approval procedure or with the applicable Regulatory Authority of a country in Europe with respect to the mutual recognition procedure or any other national approval (a \"Marketing Authorization Application\").", "": "" }, { "Text": "1.82. \"Early Exercise Data Package\" has the meaning set forth in Section 2.5.1.", "": "" }, { "Text": "1.83. \"Early Exercise Request\" has the meaning set forth in Section 2.5.1.", "": "" }, { "Text": "1.84. \"EEA\" means the European Economic Area.", "": "" }, { "Text": "1.85. \"Effective Date\" has the meaning set forth in the preamble hereto.", "": "" }, { "Text": "1.86. \"EMA\" means the European Medicines Agency and any successor agency(ies) or authority having substantially the same function.", "": "" }, { "Text": "1.87. \"European Union\" means the economic, scientific, and political organization of member states known as the European Union, as its membership may be altered from time to time, and any successor thereto.", "": "" }, { "Text": "1.88. \"Excluded Compound\" means any mutein, antibody, compound, molecule or other therapeutic that is or comprises an IL-2 Mutein for which an Fc-fusion protein that comprises such IL-2 Mutein has significantly less agonist activity to IL-2Rαβγ (expressed on CD4+Treg) compared with an Fc-fusion protein that comprises Wild-Type IL-2 and has activity to IL-2Rβγ (expressed on CD8+ T cells), as defined by the bioassay criteria listed below based on High, Medium, and Low of EC50 in the Assay, compared with an Fc-fusion protein that comprises Wild-Type IL-2 in CD4+Treg and CD8+T cells. For clarity, all Cugene Existing P19/126 Oncology Compounds shall be Excluded Compounds.", "": "" }, { "Text": "Bioassay Criteria EC50 fold change for pSTAT5 comparing with Fc-fusion protein comprising Wild-Type IL-2 in the Assay", "": "" }, { "Text": "CD4+Treg/CD8+T", "": "" }, { "Text": "Low/High", "": "" }, { "Text": "Low/Medium", "": "" }, { "Text": "Medium/High", "": "" }, { "Text": "Medium/Medium", "": "" }, { "Text": "1.89. \"Excluded Entity\" has the meaning set forth in Section 10.2.1(u)(3).", "": "" }, { "Text": "1.90. \"Excluded Individual\" has the meaning set forth in Section 10.2.1(u)(3).", "": "" }, { "Text": "1.91. \"Exercise Notice\" has the meaning set forth in Section 3.2.1.", "": "" }, { "Text": "1.92. \"Existing Know-How\" means, as of the Effective Date, or each Bring Down Date, as applicable, all Cugene Know-How existing as of such date.", "": "" }, { "Text": "1.93. \"Existing Patents\" means, as of the Effective Date, or each Bring Down Date, as applicable, all Cugene Patents existing as of such date.", "": "" }, { "Text": "1.94. \"Existing Patents Schedule\" means Schedule 1.94, as such schedule may be updated in connection with the delivery of any Updated Disclosure Schedules.", "": "" }, { "Text": "1.95. \"Existing Regulatory Documentation\" means, as of the Effective Date or each Bring Down Date, as applicable, all Regulatory Documentation Controlled by Cugene or any of its Affiliates as of such date.", "": "" }, { "Text": "1.96. \"Exploit\" means to make, have made, import, export, use, have used, sell, have sold, or offer for sale, including to Develop, Commercialize, register, modify, enhance, improve, Manufacture, have Manufactured, hold or keep (whether for disposal or otherwise), formulate, optimize, transport, distribute, promote, market, or otherwise dispose. \"Exploitation\" means the act of Exploiting a product.", "": "" }, { "Text": "1.97. \"FDA\" means the United States Food and Drug Administration and any successor agency(ies) or authority having substantially the same function.", "": "" }, { "Text": "1.98. \"FDA's Disqualified/Restricted List\" has the meaning set forth in Section 10.2.1(u)(5).", "": "" }, { "Text": "1.99. \"FFDCA\" means the United States Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., as amended from time to time, together with any rules, regulations, and requirements promulgated thereunder (including all additions, supplements, extensions, and modifications thereto).", "": "" }, { "Text": "1.100. \"Field\" means all human and non-human diagnostic, prophylactic and therapeutic uses.", "": "" }, { "Text": "1.101. \"Final Data Package\" means the research and development report containing all data, findings, results and information described in the Initial Development Plan and Budget as being part of the Final Data Package.", "": "" }, { "Text": "1.102. \"First Commercial Sale\" means, with respect to a Licensed Product and a country or other jurisdiction, the first sale for monetary value for use or consumption by the end user of such Licensed Product in such country or other jurisdiction by AbbVie, its Affiliates or its or their Sublicensees to a Third Party after all Regulatory Approvals for such Licensed Product has been obtained in such country or other jurisdiction. Sales prior to receipt of all Regulatory Approvals for such Licensed Product in such country or other jurisdiction, such as so-called \"treatment IND sales,\" \"named patient sales,\" and \"compassionate use sales,\" shall not be construed as a First Commercial Sale.", "": "" }, { "Text": "1.103. \"FTC\" means the United States Federal Trade Commission.", "": "" }, { "Text": "1.104. \"FTE\" means the equivalent of the work of one employee full time for one Calendar Year of work performing applicable activities with respect to the Manufacturing Technology Transfer.", "": "" }, { "Text": "1.105. \"GLP Toxicology Protocol\" has the meaning set forth in Section 6.1.2(j).", "": "" }, { "Text": "1.106. \"GMP\" means the current good manufacturing practices applicable from time to time to the Manufacturing of a Licensed Therapeutic or Licensed Product or any intermediate thereof pursuant to Applicable Law.", "": "" }, { "Text": "1.107. \"Governmental Authority\" means any multinational, federal, national, state, provincial, local or other entity, office, commission, bureau, agency, political subdivision, instrumentality, branch, department, authority, board, court, arbitral or other tribunal exercising executive, judicial, legislative, police, regulatory, administrative or taxing authority or functions of any nature pertaining to government.", "": "" }, { "Text": "1.108. \"HSR Act\" means the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as codified at 15 U.S.C. § 18a, as may be amended from time to time, together with any rules, regulations and requirements promulgated thereunder (including all additions, supplements, extensions and modifications thereto).", "": "" }, { "Text": "1.109. \"HSR Clearance\" means the expiration or termination of all applicable waiting periods and requests for information (and any extensions thereof) under the HSR Act or the antitrust laws in all jurisdictions in which HSR Filings are required with respect to AbbVie's exercise of the License Option.", "": "" }, { "Text": "1.110. \"HSR Filing\" means (a) filings by Cugene and AbbVie with the United States Federal Trade Commission and the Antitrust Division of the DOJ of a Notification and Report Form for Certain Mergers and Acquisitions (as that term is defined in the HSR Act) with respect to AbbVie's exercise of the License Option, together with all required documentary attachments thereto, or (b) equivalent filings, if any, with applicable Governmental Authorities outside the United States where such filings are required.", "": "" }, { "Text": "1.111. \"HSR Proceeding\" has the meaning set forth in Section 3.2.2(d).", "": "" }, { "Text": "1.112. \"IL-2\" means the mature form of the interleukin 2 with UniProt: P60568, encoded by the gene with NCBI gene ID: 3558. For clarity, when referring to an amino acid position of an IL-2 for purposes of this Agreement, the first amino acid immediately after the signal peptide of the interleukin 2 with UniProt: P60568 shall be deemed to be the first amino acid.", "": "" }, { "Text": "1.113. \"IL-2 Mutein\" means a mutated form of IL-2 with at least one change in the amino acid sequence (i.e., UniProt: P60586) (other than the Wild-Type IL-2). For clarity, \"IL-2 Mutein\" means mutated form of IL-2 standing-alone, i.e., not linked, conjugated or fused to another antibody, compound, molecule or other therapeutic.", "": "" }, { "Text": "1.114. \"Immunology Test\" means, with respect to a mutein, antibody, compound, molecule or other therapeutic, that such mutein, antibody, compound, molecule or other therapeutic is or comprises an IL-2 Mutein for which an Fc-fusion protein that comprises such IL-2 Mutein demonstrates enhanced regulatory T cell biased agonism to IL-2Rαβγ (expressed on CD4+Treg) as opposed to IL-2Rβγ (expressed on CD8+ T cells), compared with an Fc-fusion protein that comprises Wild-Type IL-2 in the Assay, as defined by the bioassay criteria listed below based on High, Medium, and Low of EC50 in the Assay, compared with an Fc-fusion protein that comprises Wild-Type IL-2 in CD4+Treg and CD8+T cells.", "": "" }, { "Text": "Bioassay Criteria", "": "" }, { "Text": "CD4+Treg/CD8+T", "": "" }, { "Text": "High/Low", "": "" }, { "Text": "High/Medium", "": "" }, { "Text": "Medium/Low", "": "" }, { "Text": "Low/Low", "": "" }, { "Text": "*Flat line refers to close to background signal due to extremely low potency", "": "" }, { "Text": "1.115. \"In-License Agreements\" means all license and other agreements between Cugene or any of its Affiliates, on the one hand, and any Third Party, on the other hand, pursuant to which Cugene or its Affiliate in-licenses any Patents or Information that are Cugene Patents or Cugene Know-How, as applicable.", "": "" }, { "Text": "1.116. \"In-License Schedule\" means Schedule 1.116, as such schedule may be updated in connection with the delivery of any Updated Disclosure Schedules.", "": "" }, { "Text": "1.117. \"In-Licensed Patents\" has the meaning set forth in Section 10.2.1(c).", "": "" }, { "Text": "1.118. \"Included In-License Agreement\" means an In-License Agreement entered into between Cugene or any of its Affiliates, on the one hand, and any Third Party, on the other hand, prior to the License Option Effective Date.", "": "" }, { "Text": "1.119. \"IND\" means an application filed with a Regulatory Authority for authorization to commence Clinical Studies, including (a) an Investigational New Drug Application as defined in the FFDCA or any successor application or procedure filed with the FDA, (b) any equivalent of a United States Investigational New Drug Application in other countries or regulatory jurisdictions, (i.e., clinical trial application (CTA)) and (c) all supplements, amendments, variations, extensions and renewals thereof that may be filed with respect to the foregoing.", "": "" }, { "Text": "1.120. \"Indemnification Claim Notice\" has the meaning set forth in Section 11.3.1.", "": "" }, { "Text": "1.121. \"Indemnified Party\" has the meaning set forth in Section 11.3.1.", "": "" }, { "Text": "1.122. \"Indemnifying Party\" has the meaning set forth in Section 11.3.1.", "": "" }, { "Text": "1.123. \"Indication\" means, with respect to a Licensed Product, a diagnostic, prophylactic or therapeutic use for a disease or condition, with respect to which use at least one adequate and well-controlled Clinical Study is required to support the addition of such disease or condition to the indication statement of a package insert approved by a Regulatory Authority for such Licensed Product and for which a Drug Approval Application (or a supplement, extension or amendment thereto) must be filed. Notwithstanding the foregoing, each of the following shall be treated as the same Indication and not a distinct Indication: (a) the treatment of a disease or condition in a particular patient population and the treatment of the same disease or condition in another patient population or population subtype (e.g., treatments for adult populations and pediatric populations); (b) different subtypes of the same disease or condition (e.g., Cutaneous Lupus Erythematosus is the same Indication as Systemic Lupus Erythematosus), provided that each of the diseases or conditions set forth on Schedule 1.123 is deemed a separate Indication; (c) different lines of therapy for the same disease or condition; and (d) label expansions or label changes (including dose, dosing schedule, use in the same Indication in combination with various other agents, etc.) for a given Indication.", "": "" }, { "Text": "1.124. \"Indirect Taxes\" has the meaning set forth in Section 7.9.3.", "": "" }, { "Text": "1.125. \"Information\" means all information and data of a technical, scientific, business or other nature, including know-how, technology, means, methods, processes, practices, formulae, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings, assembly procedures, computer programs, specifications, results, regulatory data, and other biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical, pre-clinical, clinical, safety, manufacturing, and quality control data and information, including study designs and protocols, information regarding reagents (e.g., plasmids, proteins, cell lines, assays and compounds) and biological methodology; in each case (whether or not confidential, proprietary, patented, or patentable, of commercial advantage or not) in written, electronic, or any other form now known or hereafter developed.", "": "" }, { "Text": "1.126. \"Initial Development Plan and Budget\" means the mutually agreed research and development plan and budget, attached hereto as Schedule 1.126, as the same may be amended from time to time in accordance with the terms hereof, for the Licensed Therapeutics and Licensed Products.", "": "" }, { "Text": "1.127. \"Initial Disclosure Schedules\" has the meaning set forth in Section 10.2.1.", "": "" }, { "Text": "1.128. \"Initiation\" or \"Initiate\" means, with respect to a Clinical Study, the first dosing of the first human subject with the applicable Licensed Product in such Clinical Study in accordance with the applicable protocol and Applicable Law.", "": "" }, { "Text": "1.129. \"Joint Governance Committee\" or \"JGC\" has the meaning set forth in Section 6.1.1.", "": "" }, { "Text": "1.130. \"Joint IP\" has the meaning set forth in Section 8.1.2.", "": "" }, { "Text": "1.131. \"Joint Know-How\" has the meaning set forth in Section 8.1.2.", "": "" }, { "Text": "1.132. \"Joint Patents\" has the meaning set forth in Section 8.1.2.", "": "" }, { "Text": "1.133. \"Knowledge\" means: (a) with respect to Cugene, the actual knowledge after performing a diligent investigation with respect to the applicable facts and information of the Chief Executive Officer, VP/head of research, director of business, director of business development, internal patent prosecution counsel, internal patent litigation counsel, if any, of Cugene or any of its Affiliates or any personnel holding positions equivalent to such job titles, or the inventors (to the extent they are employees of Cugene or any of its Affiliates at the time of the determination of \"Knowledge\") of the inventions claimed in the WO2019/246404 Patent and any Patent that claims priority therefrom; provided that, until such time as Cugene has internal legal counsel (or at any time thereafter when Cugene does not have internal legal counsel), with respect to patent matters, the individuals identified in this definition of \"Knowledge\" shall have a duty to make reasonable inquiry of Cugene's outside legal counsel with respect to applicable facts and information.", "": "" }, { "Text": "1.134. \"License Option\" has the meaning set forth in Section 3.1.", "": "" }, { "Text": "1.135. \"License Option Effective Date\" means the date AbbVie delivers Cugene the Exercise Notice in accordance with Section 3.2.1; provided that, if AbbVie reasonably determines in good faith prior to the delivery of the Exercise Notice that the transactions to be consummated upon the exercise of the License Option require HSR Filings, the License Option Effective Date means the Business Day after the date on which HSR Clearance occurs.", "": "" }, { "Text": "1.136. \"License Option Exercise Payment\" has the meaning set forth in Section 7.2.", "": "" }, { "Text": "1.137. \"License Option Period\" means the time period commencing upon the Effective Date and terminating 90 days after AbbVie receives, or is deemed to have received, the complete Final Data Package from Cugene pursuant to Section 2.5.3.", "": "" }, { "Text": "1.138. \"Licensed IL-2 Mutein\" means an IL-2 Mutein, the amino acid sequence of which IL-2 Mutein is set forth in the Side Letter.", "": "" }, { "Text": "1.139. \"Licensed IP\" means the Cugene IP and Cugene's interest in the Joint IP, if any.", "": "" }, { "Text": "1.140. \"Licensed Product\" means any product containing a Licensed Therapeutic, alone or in combination with one or more other active ingredients in any and all forms, in current and future formulations, dosage forms and strengths, and delivery modes including any improvements thereto; provided that the licenses granted to AbbVie and its Affiliates under this Agreement shall not be construed to grant AbbVie or any of its Affiliates any right or license to any other active ingredient owned by, licensed to or otherwise controlled by Cugene or any of its Affiliates other than the applicable Licensed Therapeutic, except as expressly agreed by the Parties in writing.", "": "" }, { "Text": "1.141. \"Licensed Therapeutic\" means (a) (i) CUG252, (ii) any mutein, antibody, compound, molecule or other therapeutic that is or comprises the Licensed IL-2 Mutein, (iii) any mutein, antibody, compound, molecule or other therapeutic that is or comprises any IL-2 Mutein contained in the Fc-fusion protein with any of the following internal Cugene reference ID numbers CUG256 (P-0512), P-0418, P-0449, P-0491, P-0495, P-0514, P-0515, P-0591, P-0694, P-0695, P-0697, P-0698, P-0700 or P-0861, the amino acid sequence of which is set forth in the Side Letter and (iv) any other mutein, antibody, compound, molecule or other therapeutic that is or comprises a P19/126 Mutation Compound (including, solely for purposes of this subsection (a), any such mutein, antibody, compound, molecule or other therapeutic that is or comprises a P65 Mutation Compound); and (b) any other mutein, antibody, compound, molecule or other therapeutic that satisfies the Immunology Test (excluding, solely for purposes of this subsection (b), any such mutein, antibody, compound, molecule or other therapeutic that is or comprises a P65 Mutation Compound), in each case of the foregoing clauses ((a) and (b)), (i) owned or Controlled by or on behalf of Cugene or any of its Affiliates at any time, or invented by or on behalf of Cugene or any of its Affiliates alone or jointly before or on the Effective Date or at any time during the Term or (ii) developed by or on behalf of AbbVie or any of its Affiliates under this Agreement through the use of, or reliance on, any Licensed IP. For clarity, (x) the Licensed Therapeutics set forth in the foregoing clause (b) do not include the Excluded Compounds and (y) the Licensed Therapeutics set forth in the foregoing clause (a) do not include the Cugene Existing P19/126 Oncology Compounds.", "": "" }, { "Text": "1.142. \"Losses\" has the meaning set forth in Section 11.1.", "": "" }, { "Text": "1.143. \"Major European Market\" means any of the United Kingdom, Germany, France, Italy and Spain.", "": "" }, { "Text": "1.144. \"Manufacture\" and \"Manufacturing\" means all activities related to the synthesis, making, production, manufacture, processing, purifying, formulating, filling, finishing, packaging, labeling, shipping and holding of any Licensed Therapeutic, any Licensed Product or any intermediate thereof, including process development, process qualification and validation, scale-up, pre-clinical, clinical and commercial production and analytic development, product characterization, stability testing, quality assurance and quality control.", "": "" }, { "Text": "1.145. \"Manufacturing Process\" has the meaning set forth in Section 5.3.", "": "" }, { "Text": "1.146. \"Manufacturing Technology Transfer\" has the meaning set forth in Section 5.3.", "": "" }, { "Text": "1.147. \"Marketing Authorization Application\" has the meaning set forth in the definition of \"Drug Approval Application\".", "": "" }, { "Text": "1.148. \"Material Amendment\" means any material amendment to the Initial Development Plan and Budget, including (a) a change to the scope, timing or resource allocation of any Development activities that would reasonably be expected to result in an delay in the timing to complete the activities set forth in the then-current Initial Development Plan and Budget by more than four months, (b) an addition of new activities or increase in the scope of existing activities that would result in any budgetary changes that, together with any prior amendments, would result in a cumulative increase of 20% or more from the aggregate budget set forth in the Initial Development Plan and Budget attached hereto as Schedule 1.126, (c) the removal or material reduction of any of the Development activities in the then-current Initial Development Plan and Budget or (d) any material modifications to the content of a Data Package.", "": "" }, { "Text": "1.149. \"Missing Information\" has the meaning set forth in Section 2.5.3.", "": "" }, { "Text": "1.150. \"Missing Information Notice\" has the meaning set forth in Section 2.5.3.", "": "" }, { "Text": "1.151. \"Mixed Cugene Patent\" means any Other Cugene Patent that claims one or more Licensed Therapeutics or Licensed Products or the Exploitation thereof and also claims one or more other therapeutics or products or the Exploitation thereof. For clarity, any Bispecific Patent, Vitokine Patent and 418 Patent are each Mixed Cugene Patents.", "": "" }, { "Text": "1.152. \"MTA\" has the meaning set forth in Section 2.3.6.", "": "" }, { "Text": "1.153. \"Net Sale Anniversary\" has the meaning set forth in the definition of \"Royalty Term\".", "": "" }, { "Text": "1.154. \"Net Sales\" means, with respect to a Licensed Product for any period, the total amount billed or invoiced on sales of such Licensed Product during such period by AbbVie, its Affiliates, or Sublicensees in the Territory to Third Parties (including Distributors), in bona fide arm's length transactions, less the following deductions, in each case allocated specifically to such Licensed Product and actually allowed and taken by such Third Parties and not otherwise recovered by or reimbursed to AbbVie, its Affiliates or Sublicensees:", "": "" }, { "Text": "(a) normal trade, cash and quantity discounts actually given in the ordinary course of business;", "": "" }, { "Text": "(b) price reductions or rebates, retroactive or otherwise, imposed by, negotiated with or otherwise paid to Governmental Authorities or other payees;", "": "" }, { "Text": "(c) taxes on sales (such as sales, value added, or use taxes) to the extent added to the sale price and set forth separately as such in the total amount invoiced which, for clarity, exclude income taxes;", "": "" }, { "Text": "(d) amounts repaid or credited by reason of rejections, defects, return goods allowance, recalls or returns, or because of retroactive price reductions, including rebates or wholesaler charge backs;", "": "" }, { "Text": "(e) the portion of administrative fees paid during the relevant time period to group purchasing organizations, pharmaceutical benefit managers or Medicare Prescription Drug Plans to the extent allocated to such Licensed Product;", "": "" }, { "Text": "(f) if a Delivery System is bundled together with such Licensed Product and the total amount billed or invoiced includes both the Delivery System and such Licensed Product, any consideration actually paid or payable for any Delivery System related to a billed or invoiced sale of such Licensed Product, where for purposes of this Net Sales definition, a \"Delivery System\" means any delivery system comprising equipment, instrumentation, one or more devices, or other mechanical components (such as an autoinjector), which delivery system is used for the administration of such Licensed Product;", "": "" }, { "Text": "(g) any invoiced amounts from a prior period that are not collected and are written off by AbbVie, its Affiliates or Sublicensees, including bad debts; provided that the amount of any uncollected amounts or bad debt deducted pursuant to this exception and actually collected in a subsequent Calendar Quarter shall be included in Net Sales for such subsequent Calendar Quarter;", "": "" }, { "Text": "(h) that portion of the annual fee on prescription drug manufacturers imposed by the Patient Protection and Affordable Care Act, Pub. L. No. 111-148 (as amended) and reasonably allocable to sales of such Licensed Product;", "": "" }, { "Text": "(i) customary freight, insurance, import/export, and other transportation charges to the extent added to the sale price and set forth separately as such in the total amount invoiced, as well as any fees for services provided by wholesalers and warehousing chains related to the distribution of such Licensed Product; and", "": "" }, { "Text": "(j) any other similar and customary deductions that are consistent with the Accounting Standards, but which may not be duplicative of the deductions specified in Section 1.154(a) through Section 1.154(i).", "": "" }, { "Text": "In no event shall any particular amount, identified above, be deducted more than once in calculating Net Sales (i.e., no \"double counting\" of any deductions). Notwithstanding anything to the contrary in this Section 1.154, to the extent any amounts deducted pursuant to this Section 1.154 are subsequently recovered by or reimbursed to AbbVie, its Affiliates or Sublicensees, such recovered amounts shall be deemed \"Net Sales\" for the relevant subsequent Calendar Quarter in which such recoveries or reimbursements are recorded by AbbVie or such Affiliate or Sublicensee in accordance with Accounting Standards; provided that, if no royalties are owed by AbbVie for such relevant subsequent Calendar Quarter pursuant to Section 7.5, AbbVie shall calculate, report and pay the royalties due to Cugene on such amounts in accordance with Section 7.7. Net Sales shall not include transfers or dispositions for charitable, promotional, pre-clinical, clinical, regulatory, or governmental purposes. Net Sales shall include the amount or fair market value of all other consideration received by AbbVie, its Affiliates or Sublicensees in respect of the sale of the Licensed Product, whether such consideration is in cash, payment in kind, exchange or other form. Net Sales shall not include sales between or among AbbVie, its Affiliates, or Sublicensees, but the subsequent sale of such Licensed Product to a Third Party shall be included in the calculation of Net Sales.", "": "" }, { "Text": "Subject to the above, each of the components of Net Sales shall be calculated in accordance with the standard internal policies and procedures of AbbVie, its Affiliates, or Sublicensees, and, where applicable, Accounting Standards.", "": "" }, { "Text": "For purposes of calculating Net Sales, all Net Sales shall be converted into Dollars in accordance with Section 7.8.", "": "" }, { "Text": "If a Licensed Product is a Combination Product, the Net Sales for such Combination Product in each country or other jurisdiction shall be calculated as follows:", "": "" }, { "Text": "(i) If AbbVie or any of its Affiliates or Sublicensees separately sells in such country or other jurisdiction, (A) a product containing as its sole active ingredient the Licensed Therapeutic in the same strength and using the same route of administration as in such Combination Product (the \"Mono Product\") and (B) products containing as their sole active ingredients the Other Actives in the same strength and using the same route of administration as in such Combination Product, the Net Sales attributable to such Combination Product shall be calculated by multiplying actual Net Sales of such Combination Product by the fraction A/(A+B) where: \"A\" is AbbVie's (or its Affiliate's or Sublicensee's, as applicable) average Net Sales price during the period to which the Net Sales calculation applies for the Mono Product in such country or other jurisdiction and \"B\" is AbbVie's (or its Affiliate's or Sublicensee's, as applicable) average net sales price (determined in the same manner as \"Net Sales\") during the period to which the Net Sales calculation applies in such country or other jurisdiction, for products that contain as their sole active ingredients the Other Actives in the same strength and using the same route of administration as in such Combination Product.", "": "" }, { "Text": "(ii) If AbbVie or any of its Affiliates or Sublicensees separately sells in such country or other jurisdiction the Mono Product but does not separately sell in such country or other jurisdiction products containing as their sole active ingredients the Other Actives in the same strength and using the same route of administration as in such Combination Product, the Net Sales attributable to such Combination Product shall be calculated by multiplying the Net Sales of such Combination Product by the fraction A/C where: \"A\" is AbbVie's (or its Affiliate's or Sublicensee's, as applicable) average Net Sales price during the period to which the Net Sales calculation applies for the Mono Product in such country or other jurisdiction, and \"C\" is AbbVie's (or its Affiliate's or Sublicensee's, as applicable) average Net Sales price in such country or other jurisdiction during the period to which the Net Sales calculation applies for such Combination Product.", "": "" }, { "Text": "(iii) If AbbVie and its Affiliates and Sublicensees do not separately sell in such country or other jurisdiction the Mono Product but do separately sell products containing as their sole active ingredients the Other Actives in the same strength and using the same route of administration as contained in such Combination Product, the Net Sales attributable to such Combination Product shall be calculated by multiplying the Net Sales of such Combination Product by the fraction (D-E)/D where: \"D\" is the average Net Sales price during the period to which the Net Sales calculation applies for such Combination Product in such country or other jurisdiction and \"E\" is the average net sales price (determined in the same manner as \"Net Sales\") during the period to which the Net Sales calculation applies for products that contain as their sole active ingredients the Other Actives in the same strength and using the same route of administration as in such Combination Product.", "": "" }, { "Text": "(iv) If AbbVie, its Affiliates and Sublicensees do not separately sell in such country or other jurisdiction either the Mono Product or the Other Active(s) in the same strength and using the same route of administration as in such Combination Product, the Net Sales attributable to such Combination Product shall be determined by the Parties in good faith based on the relative fair market value of such Mono Product and such Other Active(s). If the Parties cannot agree on such relative value, the Dispute shall be resolved pursuant to Section 13.5.", "": "" }, { "Text": "1.155. \"Non-Breaching Party\" has the meaning set forth in Section 12.2.1.", "": "" }, { "Text": "1.156. \"Notice Period\" has the meaning set forth in Section 12.2.1.", "": "" }, { "Text": "1.157. \"Opt-In\" means opting into the jurisdiction of Unified Patent Court, such as through withdrawal under Article 83(4) of the Agreement on a Unified Patent Court between the participating member states of the European Union (2013/C 175/01) of the Opt-Out of a Patent.", "": "" }, { "Text": "1.158. \"Opt-Out\" means opting out of the jurisdiction of Unified Patent Court, such as the opt-out of a Patent from the exclusive competence of the Unified Patent Court under Article 83(3) of the Agreement on a Unified Patent Court between the participating member states of the European Union (2013/C 175/01).", "": "" }, { "Text": "1.159. \"Other Active\" has the meaning set forth in the definition of \"Net Sales\".", "": "" }, { "Text": "1.160. \"Other Cugene Patents\" means the Cugene Patents other than the Product Patents.", "": "" }, { "Text": "1.161. \"Owned Patents\" has the meaning set forth in Section 10.2.1(c).", "": "" }, { "Text": "1.162. \"P19/126 Mutation Compound\" means an IL-2 Mutein with any amino acid substitutions at both position L19 and position Q126, excluding Cugene Existing P19/126 Oncology Compounds.", "": "" }, { "Text": "1.163. \"P65 Mutation Compound\" means an IL-2 Mutein with any amino acid substitution at position P65.", "": "" }, { "Text": "1.164. \"Party\" and \"Parties\" have the meaning set forth in the preamble hereto.", "": "" }, { "Text": "1.165. \"Patents\" means: (a) all national, regional and international patents and patent applications, including provisional patent applications; (b) all patent applications filed either from such patents, patent applications or provisional applications or from an application claiming priority from either of these, including divisionals, continuations, continuations-in-part, provisionals, converted provisionals and continued prosecution applications; (c) any and all patents that have issued or in the future issue from the foregoing patent applications ((a) and (b)), including utility models, petty patents, innovation patents and design patents and certificates of invention; (d) any and all extensions or restorations by existing or future extension or restoration mechanisms, including revalidations, reissues, re-examinations and extensions (including any pediatric exclusivity, supplementary protection certificates and the like) of the foregoing patents or patent applications ((a), (b) and (c)); and (e) any similar rights, including so-called pipeline protection or registration patent of any of such foregoing patent applications and patents.", "": "" }, { "Text": "1.166. \"Permitted Entities\" has the meaning set forth in Section 2.3.4.", "": "" }, { "Text": "1.167. \"Person\" means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, unincorporated association, joint venture or other similar entity or organization, including a government or political subdivision, department or agency of a government.", "": "" }, { "Text": "1.168. \"Personal Data\" means (a) all information identifying, or in combination with other information, identifiable to an individual, including pseudonymized (key-coded) data from Clinical Studies containing such information; and (b) any other information that is governed, regulated, or protected by one or more Data Protection Laws.", "": "" }, { "Text": "1.169. \"Phase Ia Clinical Trial\" means a human Clinical Study of a Licensed Product, the principal purpose of which is a preliminary determination of safety, pharmacokinetics, and pharmacodynamic parameters in healthy individuals, including the applicable trials referred to in 21 C.F.R. § 312.21(a), as amended from time to time, or the corresponding foreign regulations.", "": "" }, { "Text": "1.170. \"Phase Ib Clinical Trial\" means a human Clinical Study that provides for the first introduction of a Licensed Product into patients having the disease of interest with the primary purpose of determining safety and pharmacokinetic properties and clinical pharmacology of such Licensed Product, including the applicable trials referred to in 21 C.F.R. § 312.21(a), as amended from time to time, or the corresponding foreign regulations.", "": "" }, { "Text": "1.171. \"Phase II Clinical Trial\" means a Clinical Study of a Licensed Therapeutic or Licensed Product, the principal purpose of which is a determination of safety and efficacy in the target patient population, which is prospectively designed to generate sufficient data that may permit commencement of pivotal clinical trials, or a similar clinical study prescribed by the Regulatory Authorities, from time to time, pursuant to Applicable Law or otherwise, including the trials referred to in 21 C.F.R. §312.21(b), as amended.", "": "" }, { "Text": "1.172. \"PHSA\" means the United States Public Health Service Act, as amended from time to time.", "": "" }, { "Text": "1.173. \"Pre-Existing Entities\" has the meaning set forth in Section 4.6.2.", "": "" }, { "Text": "1.174. \"Pre-Transaction Entities\" has the meaning set forth in Section 13.3.2.", "": "" }, { "Text": "1.175. \"Preliminary Final Data Package\" has the meaning set forth in Section 2.5.3.", "": "" }, { "Text": "1.176. \"Privacy and Security Obligations\" has the meaning set forth in Section 10.2.1(i).", "": "" }, { "Text": "1.177. \"Processing\" means any operation or set of operations that is performed upon Personal Data, whether or not by automatic means, such as collection, recording, organization, storage, adaptation or alternation, retrieval, consultation, use, disclosure by transmission, dissemination, or otherwise making available, alignment or combination, blocking, erasure, or destruction. When used as a verb, \"Process\" means to engage in Processing.", "": "" }, { "Text": "1.178. \"Product Information\" has the meaning set forth in Section 9.1.1.", "": "" }, { "Text": "1.179. \"Product Infringement\" has the meaning set forth in Section 8.3.1.", "": "" }, { "Text": "1.180. \"Product Labeling\" means, with respect to a Licensed Product in a country or other jurisdiction in the Territory, (a) the Regulatory Authority approved full prescribing information for such Licensed Product for such country or other jurisdiction, including any required patient information, and (b) all labels and other written, printed, or graphic matter upon a container, wrapper, or any package insert utilized with or for such Licensed Product in such country or other jurisdiction.", "": "" }, { "Text": "1.181. \"Product Patent\" means any Cugene Patent that claims one or more Licensed Therapeutics or Licensed Products or the Exploitation thereof and does not claim one or more other therapeutics or products or the Exploitation thereof. For clarity, none of the following are Product Patents: (a) any Bispecific Patent, (b) any Vitokine Patent, or (c) the 418 Patent.", "": "" }, { "Text": "1.182. \"Product Trademark\" means the Trademark(s) to be used by AbbVie or its Affiliates or its or their respective Sublicensees for the Development or Commercialization of Licensed Products in the Territory and any registrations thereof or any pending applications relating thereto in the Territory (excluding, in any event, any trademarks, service marks, names, or logos that include any corporate name or logo of the Parties or their Affiliates).", "": "" }, { "Text": "1.183. \"Receiving Party\" has the meaning set forth in Section 9.1.1.", "": "" }, { "Text": "1.184. \"Registrational Trial\" means, with respect to a Licensed Product, a Clinical Study (regardless of whether such Clinical Study is referred to as a \"phase 2/3 clinical trial\", \"phase 2b/3 clinical trial\" or \"phase 3 clinical trial\") for such Licensed Product, the results of which, together with prior Information concerning such Licensed Product, are intended to be sufficient to establish that such Licensed Product is safe and effective for its intended Indication to support the filing of a Drug Approval Application for such Licensed Product, as acknowledged in writing by the FDA for a Clinical Study that is not referred to in 21 C.F.R. § 312.21(c), as amended (or by an applicable Regulatory Authority with respect to the corresponding foreign regulations). If a Clinical Study of a Licensed Product is not initially designed as a Registrational Trial but is later re-designed, converted or expanded into such a trial, then it shall be deemed to be a Registrational Trial hereunder as of the date it satisfies the criteria for a Registrational Trial (including any required written acknowledgement by a Regulatory Authority).", "": "" }, { "Text": "1.185. \"Regulatory Approval\" means, with respect to a country or other jurisdiction in the Territory, any and all approvals (including approvals of Drug Approval Applications), licenses, registrations or authorizations of any Regulatory Authority necessary to commercially distribute, sell and market a Licensed Product in such country or other jurisdiction, including, where applicable, (a) commercially reasonable pricing or reimbursement approval in such country or other jurisdiction, (b) pre- and post-approval marketing authorizations (including any prerequisite Manufacturing approval or authorization related thereto) and (c) approval of Product Labeling.", "": "" }, { "Text": "1.186. \"Regulatory Authority\" means any applicable supra-national, federal, national, regional, state, provincial, or local governmental or regulatory authority, agency, department, bureau, commission, council, or other entities (e.g., the FDA and EMA) regulating or otherwise exercising authority with respect to activities contemplated in this Agreement, including the Exploitation of a Licensed Therapeutic or Licensed Product in the Territory.", "": "" }, { "Text": "1.187. \"Regulatory Documentation\" means all (a) applications (including all INDs and Drug Approval Applications), registrations, licenses, authorizations, and approvals (including Regulatory Approvals) and (b) correspondence and reports submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority) and all supporting documents with respect thereto, including all regulatory drug lists, advertising and promotion documents, adverse event files, and complaint files, in each case ((a) and (b)), relating to a Licensed Therapeutic or Licensed Product.", "": "" }, { "Text": "1.188. \"Regulatory Exclusivity\" means, with respect to a Licensed Product in any country or other jurisdiction in the Territory, any exclusive marketing rights and data exclusivity rights (other than Patent protection) conferred by any Regulatory Authority with respect to a pharmaceutical product, including new chemical entity exclusivity, new use or indication exclusivity, new formulation exclusivity, orphan drug exclusivity, pediatric exclusivity, data exclusivity and other similar rights that may become available following the Effective Date.", "": "" }, { "Text": "1.189. \"Restricted Company\" means, with respect to a Change in Control of Cugene or Acquisition by Cugene, any Person that is a party to such Change in Control or Acquisition that, as of the effective date of such Change in Control or Acquisition is a pharmaceutical, biotechnology, medical device or diagnostic company that (a) in aggregate with its affiliates, has a market capitalization of $10,000,000,000 or greater or (b) is a private pharmaceutical, biotechnology, medical device or diagnostic companies that meet the market capitalization threshold set forth in clause (a).", "": "" }, { "Text": "1.190. \"Reversion Product\" means: (a) if this Agreement is terminated with respect to a Terminated Territory, a Licensed Product that is being Developed, Commercialized or otherwise Exploited by or on behalf of AbbVie or its Affiliates or Sublicensees under this Agreement in the Terminated Territory as of the effective date of the applicable termination of this Agreement (in its entirety or with respect to one or more countries or other jurisdictions); or (b) if this Agreement is terminated in its entirety, any Licensed Product; provided that the licenses granted to Cugene under Section 12.4 shall not be construed to grant Cugene any right or license to any other active ingredient owned by, licensed to or otherwise controlled by AbbVie or any of its Affiliates other than the Licensed Therapeutic included in the applicable Reversion Product, except as expressly agreed by the Parties in writing.", "": "" }, { "Text": "1.191. \"Review Period\" has the meaning set forth in Section 2.5.3.", "": "" }, { "Text": "1.192. \"Royalty Claim\" means, with respect to a Licensed Product in a country or other jurisdiction, a Valid Claim of a Cugene Patent in such country or other jurisdiction that claims a Licensed Therapeutic contained in such Licensed Product in such country or other jurisdiction.", "": "" }, { "Text": "1.193. \"Royalty Term\" means, with respect to each Licensed Product and each country or other jurisdiction in the Territory, the period beginning on the date of the first Net Sale of such Licensed Product in such country or other jurisdiction and ending on the latest to occur of: (a) the expiration, invalidation, irretrievable lapse, revocation, dedication to the public, disclaimer, cancellation or abandonment date of the last granted Cugene Patent that includes a Royalty Claim; (b) if the First Commercial Sale of such Licensed Product in such country or other jurisdiction has not occurred before the tenth anniversary of the first Net Sale of such Licensed Product in such country or other jurisdiction (the \"Net Sale Anniversary\"), the Net Sale Anniversary; (c) if the First Commercial Sale of such Licensed Product in such country or other jurisdiction occurs on or before the Net Sale Anniversary, the tenth anniversary of such First Commercial Sale; and (d) the expiration of the Regulatory Exclusivity in such country or other jurisdiction for such Licensed Product.", "": "" }, { "Text": "1.194. \"Safety Event\" means, with respect to a Clinical Study for a Licensed Product, the FDA or other Regulatory Authority placing a clinical hold or equivalent restriction on such Clinical Study as a result of a documented adverse event.", "": "" }, { "Text": "1.195. \"Sales Milestone Event\" has the meaning set forth in Section 7.4.", "": "" }, { "Text": "1.196. \"Sales Milestone Payment\" has the meaning set forth in Section 7.4.", "": "" }, { "Text": "1.197. \"Second Request\" has the meaning set forth in Section 12.2.4.", "": "" }, { "Text": "1.198. \"Senior Officer\" means, with respect to Cugene, its Chief Executive Officer and with respect to AbbVie, its Vice President of Immunology Therapeutic Area or any successor position with equivalent responsibilities.", "": "" }, { "Text": "1.199. \"Settlement Sublicensee\" means any Third Party to which AbbVie grants a sublicense to settle or avoid litigation or any Patent dispute related to (a) the threatened (in writing) or alleged infringement by a Licensed Product or the Exploitation thereof of any Patents or other intellectual property of a Third Party or (b) the alleged non-infringement, invalidity, or unenforceability of or challenge against any Patents Covering or claiming a Licensed Product.", "": "" }, { "Text": "1.200. \"Side Letter\" means the side letter that Cugene delivered via email on May 4, 2022 (EDT) to the Director, Business Development & Acquisitions at AbbVie who was directly involved in the negotiation of this Agreement.", "": "" }, { "Text": "1.201. \"Skipped Milestone Payments\" has the meaning set forth in Section 12.9.", "": "" }, { "Text": "1.202. \"Study Data\" has the meaning set forth in Section 2.4.2.", "": "" }, { "Text": "1.203. \"Sublicensee\" means a Person, other than an Affiliate or a Distributor, that is granted a sublicense (or further right of reference) by AbbVie or its Affiliate under the grants in Section 4.1, as provided in Section 4.3, except for a Settlement Sublicensee.", "": "" }, { "Text": "1.204. \"Successful Completion\" means (a) the achievement of Treg cell counts of approximately 2-fold increase from the pre-treatment baseline and (b) the establishment of Phase Ib Clinical Trial (MAD) starting dose (Ph1bSD) with (i) no drug related serious adverse events, (ii) no clinically significant increased toxicity compared to placebo (including as demonstrated in the lab data) and (iii) a numerical dose-dependent increase in Tregs from baseline up to cohort 4 in the Phase Ia Clinical Trial under the Initial Development Plan and Budget.", "": "" }, { "Text": "1.205. \"Term\" has the meaning set forth in Section 12.1.", "": "" }, { "Text": "1.206. \"Terminated Territory\" means each country or other jurisdiction with respect to which this Agreement is terminated by Cugene pursuant to Section 12.2.1 or by AbbVie pursuant to Section 12.2.2(b), or, if this Agreement is terminated in its entirety, the entire Territory.", "": "" }, { "Text": "1.207. \"Termination Notice\" has the meaning set forth in Section 12.2.1.", "": "" }, { "Text": "1.208. \"Territory\" means the entire world other than the Terminated Territory.", "": "" }, { "Text": "1.209. \"Third Party\" means any Person other than Cugene, AbbVie and their respective Affiliates.", "": "" }, { "Text": "1.210. \"Third Party Claims\" has the meaning set forth in Section 11.1.", "": "" }, { "Text": "1.211. \"Third Party Infringement Claim\" has the meaning set forth in Section 8.4.1.", "": "" }, { "Text": "1.212. \"Third Party Payments\" has the meaning set forth in Section 7.5.4.", "": "" }, { "Text": "1.213. \"Trademark\" means any word, name, symbol, color, shape, designation or any combination thereof, including any trademark, service mark, trade name, brand name, sub-brand name, trade dress, product configuration, program name, delivery form name, certification mark, collective mark, logo, tagline, slogan, design or business symbol, that functions as an identifier of source or origin, whether or not registered and all statutory and common law rights therein and all registrations and applications therefor, together with all goodwill associated with, or symbolized by, any of the foregoing.", "": "" }, { "Text": "1.214. \"Transition Agreement\" has the meaning set forth in Section 12.5.1.", "": "" }, { "Text": "1.215. \"Triggering Event\" has the meaning set forth in Section 12.9.", "": "" }, { "Text": "1.216. \"Unfinished Initial Development Activities\" has the meaning set forth in Section 3.3.", "": "" }, { "Text": "1.217. \"United States\" or \"U.S.\" means the United States of America and its territories and possessions (including the District of Columbia and Puerto Rico).", "": "" }, { "Text": "1.218. \"Updated Disclosure Schedules\" has the meaning set forth in Section 10.2.2(c).", "": "" }, { "Text": "1.219. \"Valid Claim\" means, with respect to a claim of any issued and unexpired Patent, that the validity, enforceability or patentability of such claim has not been affected by (a) irretrievable lapse, abandonment, revocation, dedication to the public or disclaimer or (b) a holding, finding or decision of invalidity, unenforceability or non-patentability by a court, governmental agency, national or regional patent office or other appropriate body that has competent jurisdiction, such holding, finding or decision being final and unappealable or unappealed within the time allowed for appeals.", "": "" }, { "Text": "1.220. \"Vitokine Patent\" means any Cugene Patent related to cytokine-based bioactivatable drugs, including WO/2019/246392 and WO/2021/119516.", "": "" }, { "Text": "1.221. \"Voting Stock\" has the meaning set forth in the definition of \"Change in Control\".", "": "" }, { "Text": "1.222. \"Warranty\" has the meaning set forth in Section 3.4.3.", "": "" }, { "Text": "1.223. \"Warranty Inventory\" has the meaning set forth in Section 3.4.3.", "": "" }, { "Text": "1.224. \"Wild-Type IL-2\" means the naturally occurring human IL-2 with C125S amino acid substitution.", "": "" }, { "Text": "1.225. \"Withholding Amount\" has the meaning set forth in Section 7.9.2.", "": "" }, { "Text": "1.226. \"Withholding Party\" has the meaning set forth in Section 7.9.2.", "": "" }, { "Text": "1.227. \"Working Group\" has the meaning set forth in Section 6.3.", "": "" }, { "Text": "1.228. \"WuXi\" means WuXi Biologics (Hong Kong) Limited, a company incorporated under the laws of Hong Kong.", "": "" }, { "Text": "1.229. \"WuXi Agreement\" means the cell line license agreement entered into between WuXi and Cugene on April 2, 2019.", "": "" }, { "Text": "ARTICLE 2 INITIAL DEVELOPMENT", "": "" }, { "Text": "2.1. Initial Development Plan and Budget.", "": "" }, { "Text": "2.1.1. Review of the Initial Development Plan and Budget. The JGC shall review the Initial Development Plan and Budget at least once each Calendar Quarter, or more frequently as determined by the JGC, for the purpose of considering appropriate amendments thereto, and either Party, through its representatives on the JGC, may propose amendments to the Initial Development Plan and Budget at any time. No amendment to the Initial Development Plan and Budget shall be effective unless and until approved by the JGC or pursuant to Section 6.2.4, if applicable.", "": "" }, { "Text": "2.1.2. Principle Objective. The principle objective of the activities under Initial Development Plan and Budget is for Cugene to Develop and explore the potential for further Development of the Licensed Therapeutics and Licensed Products; it being understood that this Section 2.1.2 is not intended and shall not be construed to impose any obligation on Cugene to conduct any Clinical Studies other than those set forth in the Initial Development Plan and Budget as of the Effective Date unless approved by the JGC or pursuant to Section 6.2.4, if applicable.", "": "" }, { "Text": "2.2. Diligence. Cugene shall perform the activities set forth in the Initial Development Plan and Budget and shall use Commercially Reasonable Efforts to achieve the objectives of the Initial Development Plan and Budget in accordance with the agreed timelines set forth therein; provided that, if a Safety Event occurs with respect to any Clinical Study under the Initial Development Plan and Budget, Cugene may (a) delay or suspend such Clinical Study if Cugene in good faith believes that such Clinical Study should be delayed or suspended or (b) terminate such Clinical Study upon approval by the JGC, subject to Section 6.2.4(a), if applicable.", "": "" }, { "Text": "2.3. Performance of Initial Development and Regulatory Activities.", "": "" }, { "Text": "2.3.1. Development. Subject to Section 2.2, Cugene shall and shall use Commercially Reasonable Efforts to cause applicable Third Party contractors to (a) perform all of the Development activities assigned to it under the Initial Development Plan and Budget (including all regulatory activities in support thereof) in good scientific manner and in compliance with all Applicable Law and (b) allocate sufficient time, effort, equipment, and skilled personnel to complete such Development activities in accordance with the Initial Development Plan and Budget. Notwithstanding the foregoing, AbbVie shall (i) use Commercially Reasonable Efforts to provide Cugene with support and assistance, through AbbVie's oversight role on the JGC or the applicable Working Group using AbbVie's clinical expertise and network, for the Phase Ib Clinical Trial conducted under the Initial Development Plan and Budget, including in the areas of clinical operations, trial site selection and initiation, subject recruitment, and regulatory support, and such other support and assistance through the JGC or the applicable Working Group as identified by AbbVie in support of the Initial Development Plan and Budget and (ii) collaborate with Cugene through the JGC or the applicable Working Group to design and oversee the long-term toxicology study for a Phase II Clinical Trial for a Licensed Product. For clarity, AbbVie shall not be obligated to implement, operationalize, or have any direct role in the day-to-day conduct of, the Development activities under the Initial Development Plan and Budget, but rather, AbbVie shall serve in an oversight and consultative capacity through the JGC or the Working Groups, as applicable.", "": "" }, { "Text": "2.3.2. Regulatory.", "": "" }, { "Text": "(a) Cugene shall have the sole right and responsibility to prepare, obtain and maintain all INDs and other submissions necessary to perform its obligations under the Initial Development Plan and Budget and to conduct communications with the Regulatory Authorities in the Territory with respect to the activities under the Initial Development Plan and Budget; provided that (i) Cugene shall not submit any amendment to IND or study protocol or any other regulatory submission (excluding any administrative or scheduling communications or interactions) to any Regulatory Authority that has not been approved by the JGC pursuant to Section 6.2.4(b); provided that the foregoing shall not apply with respect to a submission that Cugene determines, after consultation with the DRC, needs to be submitted to a Regulatory Authority in connection with any serious adverse event, as defined under 21 C.F.R. § 312.21(c) (or the corresponding foreign regulations), that occurs in connection with a Clinical Study under the Initial Development Plan and Budget, as long as Cugene first discusses such submission with AbbVie regulatory representatives, and (ii) Cugene shall promptly provide to AbbVie copies of all correspondence to and from any Regulatory Authority, including copies of briefing books and meeting minutes for meetings with Regulatory Authorities, and copies of any Regulatory Documentation, in each case, related to the Initial Development Plan and Budget. Before the License Option Effective Date, all Regulatory Documentation (including all INDs) in the Territory relating to the Licensed Products shall be owned by, and shall be the sole property and held in the name of, Cugene or its designated Affiliate or designee.", "": "" }, { "Text": "(b) Cugene shall notify the JGC before initiating any communication or interaction with a Regulatory Authority, excluding any administrative or scheduling communications or interactions, with respect to the Licensed Products, and Cugene shall in good faith consider any reasonable advice or comments of AbbVie or its representatives on the JGC with respect to such communication or interaction. Cugene shall, to the extent practicable, provide a reasonable period of time (but in no event less than three Business Days, except to the extent required due to timelines set by Regulatory Authorities) for AbbVie to review and comment on any communications, excluding any administrative or scheduling communications, with a Regulatory Authority with respect to the Licensed Products prior to submission of such communication.", "": "" }, { "Text": "(c) Prior to the License Option Effective Date, Cugene shall provide AbbVie with prior written notice of any scheduled meetings, conferences or discussions with a Regulatory Authority relating to a Licensed Product reasonably promptly after Cugene first receives notice of the scheduling of such meeting, conference or discussion. To the extent permitted by Applicable Law, AbbVie shall have the right, at its sole cost, to have two of its employees attend as observers in all material meetings, conferences and discussions between Cugene and a Regulatory Authority and to observe meetings of clinical investigators, data and safety monitoring boards and clinical advisory boards, in each case, with respect to the Licensed Products in the Territory.", "": "" }, { "Text": "2.3.3. Manufacturing. Cugene shall be responsible for the Manufacture and supply of all pre-clinical and clinical requirements of Licensed Therapeutics and Licensed Products and all components of the foregoing necessary to perform its obligations under the Initial Development Plan and Budget in accordance with the terms hereof.", "": "" }, { "Text": "2.3.4. Subcontracting. Cugene shall not subcontract any of its activities under the Initial Development Plan and Budget except to any Persons set forth on Schedule 2.3.4 (\"Permitted Entities\") without AbbVie's prior written consent (not to be unreasonably withheld, conditioned or delayed).", "": "" }, { "Text": "2.3.5. Development Records. Prior to completion of the Development activities under the Initial Development Plan and Budget, Cugene shall, and shall cause its Affiliates to, maintain, in good scientific manner, complete and accurate books and records pertaining to its Development activities under the Initial Development Plan and Budget, in sufficient detail to verify compliance with its obligations under the Initial Development Plan and Budget and which books and records shall (a) be appropriate for Patent and regulatory purposes, (b) be kept and maintained in compliance with Applicable Law, (c) properly reflect all work done and results achieved in the performance of its activities under the Initial Development Plan and Budget and (d) maintained separately from books and records of activities outside the scope of this Agreement. Cugene shall, or shall cause its Affiliates, as applicable, to retain such books and records until the earlier of three years after the License Option Effective Date and the last day of the Term. During the period when Cugene and its Affiliates are required to maintain such books and records under this Section 2.3.5, AbbVie shall have the right, during normal business hours and upon reasonable notice, to inspect and copy all records maintained pursuant to this Section 2.3.5; provided that AbbVie shall maintain any Confidential Information of Cugene in such records in confidence in accordance with ARTICLE 9.", "": "" }, { "Text": "2.3.6. Material Transfer Agreement. Upon AbbVie's request, Cugene shall enter into a material transfer agreement, at no additional consideration to Cugene, promptly after the Effective Date, and in no event later than 90 days after the Effective Date, pertaining to certain non-clinical Development activities (a) with respect to analytical characterization and lyophilization formulation, and (b) as otherwise agreed by the Parties (such agreement not to be unreasonably withheld, conditioned or delayed), in each case ((a) through (b)), related to the Licensed Therapeutics and Licensed Products to be performed by AbbVie and its Affiliates during the License Option Period (the \"MTA\"). The terms of the MTA shall be consistent with the foregoing sentence, the ownership of resulting intellectual property set forth in the proviso in Section 8.1.2 and other terms that are reasonable and customary for material transfer agreements in the pharmaceutical industry.", "": "" }, { "Text": "2.3.7. Samples. Cugene shall ensure that the informed consent used in connection with the Phase Ib Clinical Trial conducted under the Initial Development Plan and Budget for patients who consent to have blood samples collected in connection with such Phase Ib Clinical Trial permits Cugene to transfer (or have transferred) to AbbVie all such blood samples in accordance with Applicable Law. Cugene shall use Commercially Reasonable Efforts to amend the informed consent used in connection with the Phase Ia Clinical Trial conducted under the Initial Development Plan and Budget for patients who consent to have blood samples collected in connection with such Phase Ia Clinical Trial after the Effective Date to permit Cugene to transfer (or have transferred) to AbbVie all blood samples from such patients in accordance with Applicable Law.", "": "" }, { "Text": "2.4. Information and Reports.", "": "" }, { "Text": "2.4.1. Development Reports. Prior to Cugene's delivery of the Preliminary Final Data Package pursuant to Section 2.5.3, within 30 days following the end of each Calendar Quarter, Cugene shall provide to the JGC and AbbVie a detailed written report regarding Cugene's (and its Affiliates', if applicable) Development activities under the Initial Development Plan and Budget that shall contain sufficient detail to enable the JGC and AbbVie to assess Cugene's compliance with the Initial Development Plan and Budget, including the items set forth in Section I.A of the Initial Development Plan and Budget.", "": "" }, { "Text": "2.4.2. Study Data. Cugene shall provide AbbVie with secure access to all data, and the results of analyses thereof, in each case, generated by Cugene, any of its Affiliates or contract research organizations, clinical sites and investigators on behalf of Cugene or any of its Affiliates under the Initial Development Plan and Budget, including results and updates of the Phase Ib Clinical Trial (collectively, the \"Study Data\"), which access may be through Cugene directing any applicable contract research organization, clinical site or investigator to provide AbbVie with login credentials for any online data repository for any activities performed by or on behalf of Cugene; provided that, with respect to Study Data generated by Third Party contractors on behalf of Cugene or any of its Affiliates, Cugene will provide AbbVie with access to such Study Data when and to the extent accessible by Cugene; provided, further, that, (a) with respect to any Clinical Study Initiated before the Effective Date, such access shall be to the extent permitted by agreement(s) with any applicable Third Party contractor(s) and in accordance with Applicable Law and (b) with respect to any Study Data generated by Third Party contractors on behalf of Cugene or any of its Affiliates under agreement(s) entered into after the Effective Date and any Clinical Study Initiated after the Effective Date, Cugene shall use good faith efforts to include in such agreement(s) or study protocol(s) relevant provision(s) requiring such Third Party contractor(s) to provide all applicable Study Data to Cugene or any of its Affiliates in accordance with Applicable Law. For all Study Data provided by Cugene pursuant to this Section 2.4.2, Cugene shall ensure that all appropriate measures are in place, including informed consents and data transfer agreements, to ensure that any Personal Data contained within the Study Data may be provided in compliance with Data Protection Laws and Section 10.3.2. Notwithstanding the foregoing, if any Safety Event occurs or adverse event safety data is received or otherwise generated by Cugene, Cugene shall, within three days of the occurrence of such Safety Event or receiving or otherwise generating such data, inform the JGC.", "": "" }, { "Text": "2.4.3. Material Events. In addition to the reports and information provided pursuant to Section 2.4.1 and Section 2.4.2, Cugene shall reasonably promptly notify AbbVie with any material events related to the Development of Licensed Therapeutics or Licensed Products (e.g., clinical hold, unexpected adverse safety events, dear doctor (or other similar) letters or receipt of Regulatory Approval).", "": "" }, { "Text": "2.4.4. Cugene Existing P19/126 Oncology Compounds. Cugene shall promptly inform AbbVie in writing of (a) any changes in the Cugene internal reference name (e.g., CUG123) of either of the Cugene Existing P19/126 Oncology Compounds and (b) the sequence of each Cugene Existing P19/126 Oncology Compound once that sequence has been disclosed publicly by or on behalf of Cugene. From time to time, upon AbbVie's request and at its sole cost and expense, Cugene shall provide to (a) AbbVie or its Third Party designee reasonably acceptable to Cugene, the Cugene internal reference name (including any documentation with respect to any changes thereto) and corresponding Assay results of each Cugene Existing P19/126 Oncology Compound and (b) such Third Party designee, the sequence of each Cugene Existing P19/126 Oncology Compound. Cugene's obligations under this Section 2.4.4 with respect to each Cugene Existing P19/126 Oncology Compound shall terminate once Cugene has provided AbbVie with the sequence of such Cugene Existing P19/126 Oncology Compound.", "": "" }, { "Text": "2.5. Data Packages.", "": "" }, { "Text": "2.5.1. Early Exercise Request. At any time before completion of the activities set forth in the Initial Development Plan and Budget, if AbbVie desires to consider exercising the License Option and provides written notice to Cugene of such desire (an \"Early Exercise Request\"), then, no later than 45 days after receipt of an Early Exercise Request by AbbVie, Cugene shall deliver to AbbVie the information required to be in the Final Data Package pursuant to the Initial Development Plan and Budget as such information then exists, or to the extent it exists (an \"Early Exercise Data Package\"). If AbbVie does not exercise the License Option after its receipt of the first Early Exercise Data Package, AbbVie will retain the right to (a) provide Cugene with the second Early Exercise Request before Cugene delivers the Preliminary Final Data Package to AbbVie pursuant to Section 2.5.3, and (b) receive the second Early Exercise Data Package upon AbbVie making such second Early Exercise Request pursuant to the first sentence of this Section 2.5.1. For clarity, (i) AbbVie may only submit a total of two Early Exercise Requests, and (ii) after Cugene has delivered the second Early Exercise Data Package, unless otherwise agreed by Cugene, AbbVie shall no longer have right to request any additional Data Package (except that, for clarity, Cugene will deliver to AbbVie the Preliminary Final Data Package upon completion of the activities set forth in the Initial Development Plan and Budget pursuant to Section 2.5.3).", "": "" }, { "Text": "2.5.2. Early Exercise Data Package. With respect to each Early Exercise Data Package, as applicable, for a period of 90 days after the date Cugene provides such Early Exercise Data Package, if AbbVie believes in good faith that any of the data or information required to be included in such Early Exercise Data Package is missing, AbbVie shall have the right to request in writing that Cugene update such Data Package to include any such missing information, to the extent available and reasonably producible, and deliver a revised Early Exercise Data Package within ten Business Days after the receipt of such request from AbbVie.", "": "" }, { "Text": "2.5.3. Final Data Package. Within 60 days after completion of the activities in the Initial Development Plan and Budget that are necessary to generate the data, findings, results and information with respect to the Final Data Package, Cugene shall deliver to AbbVie the Final Data Package (such data package, the \"Preliminary Final Data Package\") and the Updated Disclosure Schedules (if applicable). Within 15 days after the date Cugene provides AbbVie with the Preliminary Final Data Package (or such longer time as AbbVie reasonably requests, the \"Review Period\"), if AbbVie believes in good faith that any of the data, findings, results or information required to be included in the Final Data Package pursuant to the then-effective Initial Development Plan and Budget is missing in the Preliminary Final Data Package (such data or information, the \"Missing Information\"), it shall provide Cugene with a written notice specifying all Missing Information that AbbVie believes in good faith is missing (such notice, a \"Missing Information Notice\"). If AbbVie does not provide Cugene with a Missing Information Notice before the end of the Review Period, AbbVie shall be deemed to have received the complete Final Data Package as of the date of delivery of the Preliminary Final Data Package by Cugene and the License Option Period shall terminate 90 days after such date of delivery. If AbbVie delivers a Missing Information Notice to Cugene, then upon Cugene's delivery of such Missing Information to AbbVie, AbbVie will have received the complete Final Data Package and the License Option Period shall terminate 90 days after the date of delivery of such Missing Information.", "": "" }, { "Text": "2.5.4. Additional Information. In addition to the Data Package(s), during the License Option Period, Cugene promptly shall provide to AbbVie, to the extent available or reasonably producible, any additional Information related to the Licensed Therapeutics and Licensed Products that Cugene or any of its Affiliates Controls as reasonably requested by AbbVie and that is necessary or reasonably useful for AbbVie to evaluate the applicable Data Package or in order to make an informed decision regarding whether to exercise the License Option, and answer reasonable questions regarding such additional Information or the information in any Data Package. For purposes of this Section 2.5.4, the obligation to provide \"additional Information\" shall be limited to Information (including Regulatory Documentation) then in existence and in Cugene's or its Affiliate's Control, the provision of which shall not require (a) Cugene or any of its Affiliates to seek consent or approval of any Third Party, or (b) the conduct by or on behalf of Cugene or any of its Affiliates of any additional Development activities or any additional analyses other than additional analyses of data then in existence and in Cugene's or its Affiliate's possession and Control that AbbVie is unable to conduct and that Cugene or any of its Affiliates can reasonably conduct within five Business Days after AbbVie's request with respect thereto.", "": "" }, { "Text": "2.6. Expenses. Cugene shall be responsible for and shall bear all costs and expenses necessary to perform its obligations under the Initial Development Plan and Budget and this ARTICLE 2.", "": "" }, { "Text": "ARTICLE 3 LICENSE OPTION", "": "" }, { "Text": "3.1. License Option. Subject to the terms and conditions of this Agreement, Cugene hereby grants to AbbVie the exclusive option to obtain the licenses set forth in Section 4.1 (the \"License Option\").", "": "" }, { "Text": "3.2. License Option Exercise.", "": "" }, { "Text": "3.2.1. Exercise Notice. AbbVie shall have the right to exercise the License Option at any time during the License Option Period by giving Cugene written notice of exercise (the \"Exercise Notice\").", "": "" }, { "Text": "3.2.2. HSR.", "": "" }, { "Text": "(a) If AbbVie reasonably determines in good faith prior to the delivery of the Exercise Notice that the transactions to be consummated upon the exercise of the License Option require HSR Filings, AbbVie shall provide the Exercise Notice to Cugene prior to the end of the License Option Period, which notice shall include AbbVie's determination that HSR Filings are required and AbbVie's commitment to complete the exercise of the License Option, subject only to HSR Clearance and the terms of this Section 3.2.2.", "": "" }, { "Text": "(b) If AbbVie determines that HSR Filings are required, each Party shall use commercially reasonable efforts to prepare and file its respective HSR Filing as promptly as is practicable and advisable, with the goal of filing the HSR Filings within ten Business Days after Cugene receives the Exercise Notice. AbbVie shall be responsible for all filing fees in connection with the filing of submissions to the FTC and DOJ under the HSR Act, and each Party shall be responsible for its costs and expenses, including attorneys' fees, incurred by it in preparing submissions or responses or responding to any Second Request or other action by the FTC or DOJ under the HSR Act.", "": "" }, { "Text": "(c) In connection with obtaining HSR Clearance, each Party shall (i) cooperate with the other Party in connection with any investigation or other inquiry relating to an HSR Filing and the exercise of the License Option; (ii) keep the other Party or its counsel informed of any material communication received from or given to the FTC or DOJ relating to the HSR Filings and the transactions contemplated by this Agreement (and provide a copy to the other Party if such material communication is in writing); and (iii) to the extent practicable, permit the other Party or its counsel to review in advance, and in good faith consider the views of the other Party or its counsel concerning, any submission, filing or communication (and documents submitted therewith) intended to be given to the FTC or DOJ; provided, however, that a Party may redact discussions of the transaction value and reasonably designate applicable materials for review by the other Party's outside counsel only. Notwithstanding anything to the contrary herein, AbbVie shall determine the strategy to be pursued for and lead the effort to obtain HSR clearance, and Cugene shall cooperate fully and take all reasonable actions to support AbbVie therewith.", "": "" }, { "Text": "(d) AbbVie and Cugene shall each use commercially reasonable efforts to resolve as promptly as practicable any objections that may be asserted by the FTC, the DOJ, or any other Governmental Authority with respect to the transactions notified in the HSR Filings. Nothing in this Section 3.2.2 or otherwise in this Agreement shall require AbbVie to (i) offer, accept or agree to sell, divest (including through a license or a reversion of licensed or assigned rights), hold separate, transfer, or dispose of any assets, operations, rights, product lines, or businesses, or interests therein, of itself or any of its Affiliates (or consent to any of the foregoing actions), (ii) offer, accept or agree to any restraint, prohibition or limitation on the ownership, operation or conduct of all or any portion of the businesses or assets of itself or any of its Affiliates in any part of the world, including any requirement to obtain the prior approval of, or to provide prior notice to, any Governmental Authority before entering into any acquisition, contract or other transaction or (iii) litigate or otherwise formally oppose any determination (whether judicial or administrative in nature) by a Governmental Authority seeking to impose any of the restrictions referenced in clause (i) or (ii) above (such litigation or judicial or administrative proceeding, an \"HSR Proceeding\").", "": "" }, { "Text": "(e) If AbbVie determines that HSR Filings are necessary, then all rights and obligations related to the exercise of the License Option (including the payment under Section 7.2 and the granting of the licenses in Section 4.1 and ARTICLE 5 generally) shall be tolled until the HSR Clearance.", "": "" }, { "Text": "3.3. Licensed Therapeutic and Licensed Product Responsibility. From and after the License Option Effective Date, AbbVie shall have the sole right to Exploit the Licensed Therapeutics and Licensed Products in the Field in the Territory in accordance with all Applicable Law and this Agreement and shall, subject to the terms of this Agreement, be responsible for such Exploitation; provided that if, as of the License Option Effective Date, Cugene has not completed the activities set forth in the then-current Initial Development Plan and Budget (including, for clarity, delivery to AbbVie of, if applicable, the Final Data Package or Missing Information listed on the Missing Information Notice, but excluding any Clinical Study that Cugene has suspended or terminated in accordance with Section 2.2), then (a) Cugene shall continue to perform, at its own cost and expense, any activities under the then-current Initial Development Plan and Budget that are unfinished as of the License Option Effective Date (\"Unfinished Initial Development Activities\"), in accordance with the then-current Initial Development Plan and Budget, as and to the extent requested in writing by AbbVie; or (b) AbbVie shall have the right to conduct any Unfinished Initial Development Activities that AbbVie does not request Cugene to complete pursuant to the immediately preceding sentence. With respect to any Unfinished Initial Development Activities conducted by AbbVie, Cugene shall reimburse AbbVie for AbbVie's out-of-pocket costs reasonably and actually incurred with respect to such Unfinished Initial Development Activities conducted by AbbVie in accordance with the Initial Development Plan and Budget within 30 days after receipt of an invoice with respect thereto, which invoice shall contain reasonable documentation regarding out-of-pocket costs; provided that Cugene shall not be obligated to reimburse AbbVie any amounts for such Unfinished Initial Development Activities in excess of the amounts budgeted for such Unfinished Initial Development Activities in the then-current Initial Development Plan and Budget.", "": "" }, { "Text": "3.4. Additional Cugene Obligations. After the License Option Effective Date, and without additional consideration to Cugene (other than as set forth in this Section 3.4 or mutually agreed by the Parties in writing and without limiting AbbVie's payment obligations under ARTICLE 7):", "": "" }, { "Text": "3.4.1. Upon AbbVie's request, Cugene shall (and, in the case of agreements to which an Affiliate of Cugene is a party, shall cause such Affiliate to), assign to AbbVie, and AbbVie shall assume, any agreements, other than the In-License Agreements, to the extent relating to the Development or Manufacture of the Licensed Therapeutics and Licensed Products to which Cugene or any of its Affiliates is a party; provided that, to the extent that the assignment by Cugene (or its Affiliate, as applicable) of any agreement pursuant to this Section 3.4.1 requires any notice to, or consent of, the relevant Third Party counterparty to such agreement, or requires the separation of such agreement into an agreement that is retained by Cugene (or its Affiliate, as applicable) and an agreement that is assignable to (or entered into by) AbbVie, as applicable, (a) Cugene shall (or shall cause its Affiliate, as applicable, to) give such notice and (b) the Parties shall reasonably cooperate to (i) obtain such consent or (ii) at the request and with the reasonable assistance of AbbVie, negotiate such separation, in each case ((a) and (b)), as soon as practicable; provided that: (A) if neither of the options set forth in (i) and (ii) above is feasible, the Parties shall work together to determine an appropriate plan to transition the applicable activities subject to such agreement; (B) with respect to any agreement to be assigned by Cugene (or its Affiliate, as applicable) pursuant to this Section 3.4.1, neither Cugene nor any of its Affiliates shall be required to make any payments or agree to any material undertakings in connection therewith; and (C) with respect to each agreement that has been assigned by Cugene or any of its Affiliates to AbbVie, AbbVie shall be responsible for all payments incurred to a Third Party with respect to such assigned agreement from and after the effective date of such assignment. Until such notice is given, such consent is obtained or such separation is executed, the Parties will reasonably cooperate to provide to AbbVie the benefits under such agreement to the extent applicable to the rights to be assigned to and obligations to be assumed by AbbVie and such that AbbVie could perform its obligations under this Agreement.", "": "" }, { "Text": "3.4.2. Upon AbbVie's request, Cugene shall transfer to AbbVie (a) copies of (i) all data, reports, records, materials and other information arising out of the activities under the Initial Development Plan and Budget or any Manufacturing activities thereunder, including all records maintained pursuant to Section 2.3.5 and (ii) any other non-clinical data relating to the Licensed Therapeutics and Licensed Products that is included within the Cugene Know-How, provided that Cugene may redact any data to the extent not necessary or reasonably useful for the Exploitation of the Licensed Therapeutics or Licensed Products; and (b) the file wrappers and other documents and materials relating to the prosecution, defense, maintenance, validity and enforceability of the Product Patents, provided that Cugene may redact any information contained in such file wrappers and other documents and materials to the extent not necessary or reasonably useful for the prosecution, defense and maintenance of the Product Patents.", "": "" }, { "Text": "3.4.3. Cugene shall transfer to AbbVie all of its remaining GMP inventory of the Licensed Therapeutics and Licensed Products produced in accordance with the Initial Development Plan and Budget. Cugene shall deliver such inventory to AbbVie FCA (as defined in Incoterms 2010) at a location designated by AbbVie. Cugene shall label any such inventory that complies with the Warranty as \"Warranty Inventory\". Cugene represents and warrants that, to Cugene's Knowledge and at the time of delivery, the Warranty Inventory (a) will have been Manufactured, exported and imported in accordance with Applicable Law, including GMP, (b) will not be adulterated or misbranded under the FFDCA and may be introduced into interstate commerce pursuant to the FFDCA, and (c) will comply with the applicable specifications with respect thereto (the \"Warranty\"). If the Warranty Inventory does not conform with the requirements set forth in subsection (a), (b) or (c) above, upon AbbVie's request and at AbbVie's cost, Cugene will enforce compliance by WuXi with the terms of the application agreement between Cugene and WuXi that are applicable to such non-conforming Warranty Inventory. Cugene will, as and to the extent requested by AbbVie and at AbbVie's cost and expense, supply, or cause WuXi to supply, to AbbVie GMP materials of the Licensed Therapeutics and Licensed Products to the extent required by AbbVie for Phase II Clinical Trials, which request and supply may occur before the License Option Effective Date. At AbbVie's request, Cugene and AbbVie shall enter into a supply agreement and a quality agreement, negotiated and agreed to by the Parties in good faith, setting forth any additional terms and conditions of the foregoing supply and quality obligations as are reasonable and customary for similar supply agreements.", "": "" }, { "Text": "3.4.4. Upon the License Option Effective Date, to the extent permitted by Applicable Law, Cugene shall transfer and assign, or cause to be transferred and assigned, to AbbVie all of its right, title, and interest in and to all Regulatory Documentation then Controlled by Cugene or its Affiliates applicable to the Licensed Therapeutics and the Licensed Products and to the extent necessary for AbbVie to Exploit the Licensed Therapeutics and Licensed Products in the Field in the Territory. Cugene shall deliver true, correct and complete copies of all such Regulatory Documentation to AbbVie within 30 days after the License Option Effective Date (or, with respect to any such Regulatory Documentation that is in the possession of a Third Party, such longer time as Cugene reasonably requires to deliver such copies not to exceed an additional 15 days) at a time mutually agreed upon by AbbVie and Cugene, and take such other actions and execute such other instruments, assignments and documents as may be necessary to effect, evidence, register and record the transfer, assignment or other conveyance of rights under this provision.", "": "" }, { "Text": "3.4.5. Without limiting Section 3.4.2, Cugene shall assist and cooperate with AbbVie as AbbVie may reasonably request in the transition of prosecution, maintenance, enforcement and defense of the Product Patents from Cugene to AbbVie.", "": "" }, { "Text": "3.4.6. Promptly after the License Option Effective Date, Cugene shall transfer to AbbVie in the manner and to the location specified by AbbVie (a) any blood samples of patients who consent after the Effective Date to have blood samples collected in connection with the Phase Ia Clinical Trial conducted under the Initial Development Plan and Budget that Cugene may transfer to AbbVie, and (b) all blood samples of patients who consent to have blood samples collected in connection with the Phase Ib Clinical Trial conducted under the Initial Development Plan and Budget, in each case ((a) and (b)), in accordance with Applicable Law.", "": "" }, { "Text": "3.4.7. Each Party shall duly execute and deliver, or cause to be duly executed and delivered, such instruments and shall do and cause to be done such acts and things, including the filing of such assignments, agreements, documents and instruments, as may be necessary under or as the other Party may reasonably request in connection with or to carry out more effectively the purpose of or to better assure and confirm unto AbbVie its rights to Exploit the Licensed Therapeutics and the Licensed Products in the Field in the Territory in accordance with this Agreement.", "": "" }, { "Text": "3.5. Termination of License Option. Without limiting each Party's rights to terminate this Agreement in its entirety in accordance with Section 12.2, if (a) AbbVie has not delivered an Exercise Notice prior to the expiration of the License Option Period, or (b) prior to the expiration of the License Option Period AbbVie has delivered an Exercise Notice pursuant to Section 3.2.1, but this Agreement terminates pursuant to Section 12.2.4 prior to the License Option Effective Date, the License Option and this Agreement shall automatically be deemed to terminate.", "": "" }, { "Text": "ARTICLE 4 GRANT OF RIGHTS; EXCLUSIVITY", "": "" }, { "Text": "4.1. Grants to AbbVie. Subject to Section 4.3 and Section 4.4, Cugene (on behalf of itself and its Affiliates) hereby grants to AbbVie and its Affiliates, effective upon the License Option Effective Date, (a) an exclusive (even as to Cugene and its Affiliates) license (or sublicense), with the right to grant sublicenses in accordance with Section 4.3, under the Licensed IP to Exploit the Licensed Therapeutics and Licensed Products in the Field in the Territory and (b) a non-exclusive license, with the right to grant sublicenses in accordance with Section 4.3, to use Cugene's Corporate Names solely as required to Exploit the Licensed Therapeutics and Licensed Products in the Field in the Territory and for no other purpose. Notwithstanding the foregoing, Cugene retains the right under the Licensed IP to perform the Unfinished Initial Development Activities, if any, pursuant to Section 3.3.", "": "" }, { "Text": "4.2. Grants to Cugene. AbbVie (on behalf of itself and its Affiliates) hereby grants to Cugene and its Affiliates, during the performance of Cugene's Development activities under the Initial Development Plan and Budget (including, for clarity, the Unfinished Initial Development Activities, if any, pursuant to Section 3.3), a non-exclusive, royalty-free license (or sublicense), without the right to grant sublicenses other than to Permitted Entities or other Persons consented to by AbbVie under Section 2.3.4, under the Information Controlled by AbbVie during the License Option Period that is necessary for Cugene or any of its Affiliates to perform its Development activities under the Initial Development Plan and Budget solely for Cugene and its Affiliates to perform its Development activities under the Initial Development Plan and Budget; provided that, if Cugene is required to perform any Unfinished Initial Development Activities after the License Option Period under Section 3.3(a), such license shall be automatically extended until completion of the Unfinished Initial Development Activities.", "": "" }, { "Text": "4.3. Sublicenses. Subject to the terms and conditions of this Agreement, including the rest of this Section 4.3, AbbVie shall have the right to grant sublicenses, through multiple tiers of sublicenses, under the licenses granted in Section 4.1, to its Affiliates and Third Parties; provided that any such sublicenses shall be consistent with the terms and conditions of this Agreement and shall require the applicable sublicensee to comply with the applicable terms and conditions of this Agreement, including non-use and non-disclosure obligations, and obligations to maintain books and records. AbbVie shall be responsible for any actions of its Affiliates and Sublicensees to the same extent as if such actions had been taken by AbbVie itself, and Cugene shall have the right to proceed directly against AbbVie without any obligation to first proceed against such Affiliate or Sublicensee. AbbVie shall provide Cugene with a copy of each sublicense under the Licensed IP granted to a Sublicensee with respect to the U.S., any Major European Market, China or Japan in which AbbVie grants a Third Party all material rights with respect to the Development and Commercialization of the Licensed Products in such country within 15 days after effective date of such sublicense; provided that AbbVie may reasonably redact any provisions or information that are not necessary for Cugene to determine AbbVie's compliance with this Section 4.3.", "": "" }, { "Text": "4.4. No Implied Licenses. Except as expressly provided herein, Cugene grants no other right or license, including any rights or licenses to the Cugene IP, Cugene's interests in the Joint IP, if any, Cugene's Corporate Names or any other Patent or intellectual property rights not otherwise expressly granted herein. Cugene hereby expressly reserves all rights under the Licensed IP, Cugene's Corporate Names and any other intellectual property rights not expressly licensed to AbbVie in Section 4.1, including all rights with respect to the Excluded Compounds and other muteins, antibodies, compounds, molecules or other therapeutics that are expressly excluded from the scope of Licensed Therapeutic under Section 1.141.", "": "" }, { "Text": "4.5. Confirmatory Patent License. Cugene shall, and shall cause its Affiliates to, if requested to do so by AbbVie, immediately enter into confirmatory license agreements in such form as may be reasonably requested by AbbVie and reasonably acceptable to Cugene for purposes of recording the licenses granted under Section 4.1 with such patent offices in the Territory as AbbVie considers appropriate. Until the execution of any such confirmatory licenses, so far as may be legally possible, Cugene and AbbVie shall have the same rights in respect of the Licensed IP and be under the same obligations to each other in all respects as if such confirmatory licenses had been executed. In the event of any conflict or inconsistency between this Agreement and any confirmatory license agreement, this Agreement shall control.", "": "" }, { "Text": "4.6. Exclusivity.", "": "" }, { "Text": "4.6.1. Cugene's Exclusivity Obligations. During the Term, Cugene shall not, and shall cause its Affiliates not to (a) Exploit or (b) license, authorize, appoint, or otherwise assist or enable any Third Party to, Exploit, in either case ((a) or (b)), any Competing Product in the Field in the Territory; provided that the restrictions set forth in this Section 4.6.1 shall not apply to Development and regulatory activities conducted under this Agreement in accordance with the Initial Development Plan and Budget or with AbbVie's prior written consent in its sole discretion.", "": "" }, { "Text": "4.6.2. Exceptions. Subject to Section 4.1 and Section 4.2 and the remainder of this Section 4.6.2, if during the Term, Cugene or any of its Affiliates merges or consolidates with, or is acquired by, a Third Party through a Change in Control and such Third Party or any of its Affiliates prior to such transaction (collectively, the \"Pre-Existing Entities\") is Exploiting any Competing Product as of the effective date of such transaction, Cugene shall not be in violation of Section 4.6.1, for so long as:", "": "" }, { "Text": "(a) no employees of the Pre-Existing Entity who work on or have worked on Exploiting any Competing Product shall have access to the Confidential Information of AbbVie, Product Information, Product Patents, Joint Patents or Joint Know-How;", "": "" }, { "Text": "(b) no employees of Cugene who have or have had access to, the Confidential Information of AbbVie, Product Information, Product Patents, Joint Patents or Joint Know-How work for such Pre-Existing Entity in Exploiting such Competing Product(s);", "": "" }, { "Text": "(c) all such Pre-Existing Entity's manufacturing, research, development, and commercialization activities (and the personnel conducting such activities) for such Competing Product(s) are kept separate from the Manufacturing, research, Development, and Commercialization activities for Licensed Products under this Agreement; and", "": "" }, { "Text": "(d) Cugene shall, and shall cause such Pre-Existing Entity to, establish, maintain and enforce internal safeguards reasonably designed to ensure that the foregoing requirements are satisfied.", "": "" }, { "Text": "4.6.3. Acknowledgement. Cugene acknowledges and agrees that (a) this Section 4.6 has been negotiated by the Parties, (b) the geographical and time limitations on activities set forth in this Section 4.6 are reasonable, valid and necessary in light of the Parties' circumstances and necessary for the adequate protection of the activities under this Agreement and (c) AbbVie would not have entered into this Agreement without the protection afforded it by this Section 4.6. If, notwithstanding the foregoing, a court of competent jurisdiction determines that the restrictions set forth in this Section 4.6 are too broad or otherwise unreasonable under Applicable Law, including with respect to duration, geographic scope or space, the court is hereby requested and authorized by Cugene to revise this Section 4.6 to include the maximum restrictions allowable under Applicable Law.", "": "" }, { "Text": "ARTICLE 5 DEVELOPMENT AND COMMERCIALIZATION BY ABBVIE", "": "" }, { "Text": "5.1. In General. After the License Option Effective Date, AbbVie (itself or through its Affiliates or its or their Sublicensees), at its sole cost and expense, shall, as between the Parties, have the sole right to further Develop, Manufacture, Commercialize and otherwise Exploit the Licensed Therapeutics and the Licensed Products in the Field in the Territory, including the design and performance of additional Clinical Studies, the potential expansion into additional Indications and selection of agents to be used in Combination Products.", "": "" }, { "Text": "5.2. Diligence. After the License Option Effective Date, AbbVie shall use Commercially Reasonable Efforts to Develop, seek Regulatory Approval and Commercialize one Licensed Product in the United States and three of the Major European Markets for one Indication in compliance with all Applicable Law.", "": "" }, { "Text": "5.3. Manufacturing Technology Transfer. Upon AbbVie's request at any time after the License Option Effective Date and from time to time, Cugene shall effect a full transfer to AbbVie or its designee (which designee may be an Affiliate or a Third Party manufacturer) of all Cugene Know-How and Joint Know-How relating to the then-current process for the Manufacture of the Licensed Therapeutics and Licensed Products (the \"Manufacturing Process\") and implementation thereof at facilities designated by AbbVie (such transfer and implementation, as more fully described in this Section 5.3 and in Item 7, Item 9 and Item 10 of the chart in Section II.C of the Initial Development Plan and Budget, the \"Manufacturing Technology Transfer\"). The Parties shall reasonably coordinate the activities with respect to the Manufacturing Technology Transfer to not unreasonably interfere with Cugene's operations and other activities. With respect to the Manufacturing Technology Transfer, AbbVie shall (i) not be required to pay Cugene the FTE cost for the first 500 FTE hours and (ii) pay Cugene the FTE cost for any additional assistance and support provided by Cugene or its Affiliates to AbbVie beyond the first 500 FTE hours at an hourly rate of $135 per FTE hour. For purposes of this Section 5.3, \"FTE cost\" means the product of the applicable FTE hours and the hourly rate per FTE hour. Notwithstanding the foregoing, AbbVie shall reimburse Cugene for all reasonable, documented out-of-pocket costs incurred in connection with the Manufacturing Technology Transfer. For clarity, while the Parties may from time to time discuss the logistical arrangements for the Manufacturing Technology Transfer prior to the License Option Effective Date, the Manufacturing Technology Transfer will not commence until after the License Option Effective Date.", "": "" }, { "Text": "5.3.1. Cugene shall provide, and shall cause its Affiliates to provide, and shall use commercially reasonable efforts to cause Third Party manufacturers to provide (including by using commercially reasonable efforts to negotiate contractual obligations for such Third Party manufacturers to do so under agreements entered into following the Effective Date), all reasonable assistance requested by AbbVie to enable AbbVie (or its Affiliate or designated Third Party manufacturer, as applicable) to implement the applicable Manufacturing Process at the facilities designated by AbbVie. If requested by AbbVie, such assistance shall include facilitating the entering into of agreements with applicable Third Party suppliers, including WuXi, relating to the Manufacturing Process (it being understood that Cugene does not guarantee that such suppliers shall enter into any such agreements). Without limitation of the foregoing, in connection with the Manufacturing Technology Transfer:", "": "" }, { "Text": "(a) Cugene shall make available, and shall cause its Affiliates to make available, and shall use commercially reasonable efforts to cause Third Party manufacturers to make available, to AbbVie (or its Affiliate or designated Third Party manufacturer, as applicable) from time to time as AbbVie may request, all Cugene Know-How and Joint Know-How relating to the Manufacturing Process, including methods, processes and testing/characterization Information, and all documentation constituting material support, performance advice, shop practice, standard operating procedures, manufacturing instructions, specifications as to materials to be used and control methods, in each case, that are reasonably necessary or useful to enable AbbVie (or its Affiliate or designated Third Party manufacturer, as applicable) to use and practice the Manufacturing Process;", "": "" }, { "Text": "(b) Cugene shall assign to AbbVie all of its right, title and interest in and to, and shall deliver to AbbVie, the cell banks and reference standards (and such other materials as the Parties may agree in writing) used by Cugene or any of its Affiliates or Third Party manufacturers in the Manufacturing Process;", "": "" }, { "Text": "(c) Cugene shall cause all appropriate employees and representatives of Cugene and its Affiliates, and shall use commercially reasonable efforts to cause all appropriate employees and representatives of its Third Party manufacturers, to meet with employees or representatives of AbbVie (or its Affiliate or designated Third Party manufacturer, as applicable) at the applicable manufacturing facility at mutually convenient times to assist with the working up and use of the Manufacturing Process and with the training of the personnel of AbbVie (or its Affiliate or designated Third Party manufacturer, as applicable) to the extent reasonably necessary or useful to enable AbbVie (or its Affiliate or designated Third Party manufacturer, as applicable) to use and practice the Manufacturing Process;", "": "" }, { "Text": "(d) Without limiting the generality of Section 5.3.1(c), Cugene shall cause all appropriate analytical and quality control laboratory employees and representatives of Cugene and its Affiliates, and shall use commercially reasonable efforts to cause all appropriate analytical and quality control laboratory employees and representatives of Cugene's Third Party manufacturers, to meet with employees or representatives of AbbVie (or its Affiliate or designated Third Party manufacturer, as applicable) at the applicable manufacturing facility, at mutually convenient times, to support and execute the transfer of all applicable analytical methods and the validation thereof relating to the Manufacturing Process (including all applicable Cugene Know-How, Joint Know-How, methods, validation documents and other documentation, materials and sufficient supplies of all primary and other reference standards, in each case, relating to the Manufacturing Process);", "": "" }, { "Text": "(e) Cugene shall, and shall cause its Affiliates to, take such steps, and shall use commercially reasonable efforts to cause its Third Party manufacturers to take such steps, as are reasonably necessary or useful to assist AbbVie (or its Affiliate or designated Third Party manufacturer, as applicable) in obtaining any necessary licenses, permits or approvals from Regulatory Authorities with respect to the Manufacturing Process at the applicable facilities; and", "": "" }, { "Text": "(f) Cugene shall provide, and shall cause its Affiliates and shall use commercially reasonable efforts to cause its Third Party manufacturers to provide, such other assistance as AbbVie (or its Affiliate or designated Third Party manufacturer, as applicable) may reasonably request to enable AbbVie (or its Affiliate or designated Third Party manufacturer, as applicable) to use and practice the Manufacturing Process and otherwise to Manufacture the Licensed Therapeutics and Licensed Products.", "": "" }, { "Text": "5.3.2. Cugene shall reasonably promptly disclose to AbbVie (a) all modifications, enhancements and improvements, if any, to the Manufacturing Process transferred to AbbVie pursuant to this Section 5.3 and (b) any other Manufacturing process, in each case ((a) and (b)) conceived, discovered, developed or otherwise made or acquired (whether by license, acquisition or otherwise) or otherwise Controlled by Cugene or any of its Affiliates that is necessary or reasonably useful to Manufacture the Licensed Therapeutics and Licensed Products. At AbbVie's request, Cugene shall provide AbbVie with reasonable assistance to enable AbbVie (or its Affiliate or designated Third Party manufacturer, as applicable) to implement such modifications, enhancements and improvements, and AbbVie shall reimburse Cugene for the reasonable internal costs and out-of-pocket costs incurred by Cugene with respect to such assistance.", "": "" }, { "Text": "5.4. Subcontracting; Distributors. AbbVie shall have the right to subcontract any of its Development, Manufacturing or Commercialization activities to a Third Party (including by appointing one or more contract sales forces, co-promotion partners or Distributors); provided that no such permitted subcontracting shall relieve AbbVie of any obligation hereunder (except to the extent satisfactorily performed by such subcontractor). AbbVie is responsible for the compliance of its subcontractors with the terms and conditions of this Agreement and shall ensure such subcontractors are bound by written obligations of confidentiality and non-use consistent with this Agreement. Any act or omission of a subcontractor that would be a material breach of this Agreement if performed by AbbVie will be deemed to be a material breach by AbbVie under this Agreement.", "": "" }, { "Text": "5.5. Records; Development and Commercialization Reports.", "": "" }, { "Text": "5.5.1. AbbVie shall, and shall cause its Affiliates and Sublicensees to, maintain, in good scientific manner, complete and accurate books and records pertaining to its activities under this Agreement conducted after the License Option Effective Date, which books and records shall (a) be appropriate for Patent and regulatory purposes, (b) be kept and maintained in compliance with Applicable Law, (c) properly reflect all work done and results achieved in the performance of its activities hereunder after the License Option Effective Date and (d) maintained separately from books and records of activities outside the scope of this Agreement. AbbVie shall, or shall cause its Affiliates and Sublicensees, as applicable, to retain such books and records for at least three years after the expiration or termination of this Agreement in its entirety or for such longer period as may be required by Applicable Law.", "": "" }, { "Text": "5.5.2. No later than 30 days after the License Option Effective Date, AbbVie will provide Cugene with a Development plan, including anticipated Development activities to be conducted during the next 24-month period. After the License Option Effective Date, no later than 30 days after the end of each Calendar Year, AbbVie shall provide Cugene a written report at a reasonable level of detail, which report shall set forth: (a) the Development and Commercialization activities with respect to the Licensed Products conducted by or on behalf of AbbVie since the last such summary was provided hereunder (or since the License Option Effective Date with respect to the first such summary) and (b) until the first Regulatory Approval of a Licensed Product for one Indication in each of the U.S. and three of the Major European Markets, its Development plan, including anticipated Development activities to be conducted during the next 24-month period, for obtaining the first Regulatory Approval of a Licensed Product for one Indication in the U.S. and three of the Major European Markets. Cugene shall have the right to submit to AbbVie any questions or reasonable requests for additional information relating to any such report within 15 days after AbbVie provides Cugene with such report, and AbbVie will respond to such questions or reasonable requests for additional information relating to any such report in a timely manner. In addition, a follow-up meeting, which may be held via means of teleconference, videoconference or other similar communications equipment, shall be scheduled between the Parties within the month following receipt by Cugene of each yearly report mentioned above in order to discuss the content of such report. The Parties shall bear their own costs and expense in relation to their participation to such follow-up meeting. Any follow-up meeting may be cancelled if the Parties jointly agree that such meeting is not necessary. During such follow-up meeting, Cugene may be assisted at their own expense by a Third Party expert, subject to the prior written consent of AbbVie (which consent not to be unreasonably withheld, conditioned or delayed) and provided that (a) the name of such Third Party expert has been provided in writing to AbbVie prior to the meeting and (b) such Third Party expert is bound by written obligations of, and Cugene shall enforce, the confidentiality and non-use obligations under ARTICLE 9 in accordance with Section 9.4.", "": "" }, { "Text": "5.6. Regulatory Activities.", "": "" }, { "Text": "5.6.1. After the License Option Effective Date, AbbVie shall, as between the Parties, have the sole right to prepare, obtain and maintain Drug Approval Applications (including the setting of the overall regulatory strategy therefor), other Regulatory Approvals and other submissions and to conduct communications with the Regulatory Authorities in the Territory for the Licensed Products at AbbVie's cost. Cugene and its Affiliates shall, at AbbVie's cost, support AbbVie, as may be reasonably necessary, in obtaining Regulatory Approvals for the Licensed Products and in the activities in support thereof, including providing all documents or other materials in the possession or control of Cugene or any of its Affiliates as may be necessary or reasonably useful for AbbVie or any of its Affiliates or its or their Sublicensees to obtain Regulatory Approvals for the Licensed Products, including the documents and materials set forth in Item 6 of the chart in Section II.C of the Initial Development Plan and Budget; provided that Cugene may redact any information contained in such documents and materials to the extent that is not necessary or reasonably useful for AbbVie or any of its Affiliates or its or their Sublicensees to obtain Regulatory Approvals for the Licensed Products.", "": "" }, { "Text": "5.6.2. After the License Option Effective Date, all Regulatory Documentation (including all Regulatory Approvals) in the Territory relating to the Licensed Products shall be owned by, and shall be the sole property and held in the name of, AbbVie or its designated Affiliate, Sublicensee or designee.", "": "" }, { "Text": "5.7. Adverse Event and Safety Information Agreement. Within 90 days after the License Option Effective Date, the Parties shall enter into an agreement (the \"Adverse Event and Safety Information Agreement\") to initiate a process for the exchange of adverse event safety data in a mutually agreed format in order to monitor the safety of Licensed Products and to meet reporting requirements with any applicable Regulatory Authority. Notwithstanding the foregoing, if any Safety Event occurs or adverse event safety data is received or otherwise generated by Cugene prior to the execution of the Adverse Event and Safety Information Agreement, Cugene shall, within three days of receiving or otherwise generating such data, inform and provide such data to AbbVie by email at PPDMedicalServicesSafety@abbvie.com .", "": "" }, { "Text": "ARTICLE 6 COLLABORATION MANAGEMENT", "": "" }, { "Text": "6.1. Joint Governance Committee.", "": "" }, { "Text": "6.1.1. Formation. Within 15 days after the Effective Date, the Parties shall establish a joint governance committee (the \"Joint Governance Committee\" or \"JGC\") to serve as the oversight and decision-making body for the activities to be conducted by the Parties pursuant to this Agreement during the License Option Period and, if applicable, the Unfinished Initial Development Activities to be conducted by Cugene if Cugene is required to perform any such activities after the License Option Period under Section 3.3(a), as more fully described in this ARTICLE 6. The Parties anticipate that the JGC shall serve as a collaborative forum for discussion and coordination between the Parties during the License Option Period.", "": "" }, { "Text": "6.1.2. Responsibilities. During the License Option Period, the JGC shall perform the following functions, subject to the final decision-making authority of the respective Parties as set forth in Section 6.2.4:", "": "" }, { "Text": "(a) oversee the Development of, and regulatory activities for, Licensed Therapeutics and Licensed Products in the Field in the Territory pursuant to the Initial Development Plan and Budget;", "": "" }, { "Text": "(b) periodically (no less often than once per Calendar Quarter) review and serve as a forum for discussing the Initial Development Plan and Budget, and review and approve amendments thereto, including any Material Amendment;", "": "" }, { "Text": "(c) serve as a forum for discussing, reviewing and approving any submissions to Governmental Authorities (or decisions to decline to do so) with respect to the preparation, filing, prosecution and maintenance by Cugene of Product Patents pursuant to Section 8.2.1(b);", "": "" }, { "Text": "(d) coordinate the Parties' activities under this Agreement;", "": "" }, { "Text": "(e) serve as a forum for providing advice and assistance on the conduct of the Phase Ib Clinical Trial for a Licensed Product in accordance with the Initial Development Plan and Budget, including advising Cugene on matters related to site selection, initiation and recruitment strategies;", "": "" }, { "Text": "(f) review and discuss all real-time data and information received by either Party from activities conducted by contract research organizations, clinical sites and investigators under the Initial Development Plan and Budget;", "": "" }, { "Text": "(g) review and discuss all material safety and efficacy data and information received by either Party under the Initial Development Plan and Budget, including any material toxicology or pharmacokinetics issue;", "": "" }, { "Text": "(h) serve as a consultation forum for discussing any clinical hold placed on a Licensed Product and for discussing, reviewing and approving any Clinical Study that Cugene, after consultation with the DRC (if any), proposes to terminate due to a Safety Event;", "": "" }, { "Text": "(i) serve as a forum for discussing and reviewing any amendment to IND, study protocol or other regulatory submission for a Licensed Product to be filed by Cugene, or any communication or interaction with a Regulatory Authority, excluding any administrative or scheduling communications or interactions, pursuant to Section 2.3.2 and approving any such amendment to IND, study protocol or other regulatory submission;", "": "" }, { "Text": "(j) serve as a forum for discussing, reviewing and approving the study protocol for the GLP toxicology study (the \"GLP Toxicology Protocol\") to be performed under the Initial Development Plan and Budget;", "": "" }, { "Text": "(k) serve as an initial forum for discussion of, and attempt to resolve, any issues or Disputes that may arise between the Parties or otherwise under this Agreement; and", "": "" }, { "Text": "(l) perform such other functions as are set forth herein or as the Parties may mutually agree in writing, except where in conflict with any provision of this Agreement.", "": "" }, { "Text": "For clarity, the JGC shall not have any authority beyond the specific matters set forth in this Section 6.1.2, and in particular shall not have any power to amend or modify the terms of this Agreement or waive a Party's compliance with this Agreement or to decide or resolve any issues other than those specifically subject to JGC approval in this Section 6.1.2.", "": "" }, { "Text": "6.2. General Provisions Applicable to the JGC.", "": "" }, { "Text": "6.2.1. Composition. The JGC shall consist of three representatives from each Party, each with the requisite experience and seniority to enable such representative to make decisions on behalf of the applicable Party with respect to the issues falling within the jurisdiction of the JGC. From time to time, each Party may substitute one or more of its representatives to the JGC on written notice to the other Party, which notice may be given by e-mail sent to the other Party's members of the JGC. Cugene shall select from its representatives the chairperson for the JGC. From time to time, Cugene may change the representative who will serve as chairperson on written notice to AbbVie.", "": "" }, { "Text": "6.2.2. Meetings and Minutes. The JGC shall meet monthly or as otherwise agreed to by the Parties until the initiation of the first Phase Ib Clinical Trial for a Licensed Product conducted in accordance with the Initial Development Plan and Budget. Thereafter, the JGC shall meet quarterly or as otherwise agreed to by the Parties. The location of such meetings shall alternate between locations designated by Cugene and locations designated by AbbVie. Alternatively, the JGC may meet by means of teleconference, videoconference or other similar communications equipment as mutually agreed upon by the representatives of each Party. The chairperson of the JGC shall be responsible for calling meetings on no less than ten Business Days' notice. Each Party shall make all proposals for agenda items and shall provide all appropriate information with respect to such proposed items at least five Business Days in advance of the applicable meeting; provided that under exigent circumstances requiring input by the JGC a Party may provide its agenda items to the other Party within a shorter period of time in advance of the meeting, or may propose that there not be a specific agenda for a particular meeting, so long as the other Party consents to such later addition of such agenda items or the absence of a specific agenda for such meeting, such consent not to be unreasonably withheld or delayed. The chairperson of the JGC shall prepare and circulate for review and approval of the Parties minutes of each meeting within 30 days after the meeting. The Parties shall agree on the minutes of each meeting promptly, but in no event later than the next meeting of the JGC, and such approved minutes shall be signed by each Alliance Manager.", "": "" }, { "Text": "6.2.3. Procedural Rules. The JGC shall have the right to adopt such standing rules as shall be necessary for its work, which shall be consistent with this Agreement. A quorum of the JGC shall exist whenever there is present at a meeting at least one representative appointed by each Party. Representatives of the Parties may attend a meeting either in person or by telephone, video conference, or similar means in which each participant can hear what is said by, and be heard by, the other participants. Representation by proxy shall be allowed. The JGC shall take action by consensus of the representatives present at a meeting at which a quorum exists, with each Party having a single vote irrespective of the number of representatives of such Party in attendance, or by a written resolution signed by at least one representative appointed by each Party. Alliance Managers and other employees of either Party that are not representatives of the Parties may attend meetings of the JGC; provided that such attendees (a) shall not vote or otherwise participate in the decision-making process of the JGC and (b) are bound by obligations of confidentiality and non-disclosure equivalent to those set forth in ARTICLE 9.", "": "" }, { "Text": "6.2.4. Decision-Making. If the JGC cannot, or does not, reach consensus on an issue at a meeting or within a period of ten Business Days thereafter, or such other period as the Parties may agree, including any dispute arising in a Working Group, then the dispute shall first be referred to the Senior Officers of the Parties, who shall confer in good faith on the resolution of the issue. Any final decision mutually agreed to by the Senior Officers in writing shall be conclusive and binding on the Parties. If the Senior Officers are not able to agree on the resolution of any such issue within 15 Business Days after such issue was first referred to them, then:", "": "" }, { "Text": "(a) Cugene shall have final decision-making authority with respect to conduct of activities performed pursuant to the Initial Development Plan and Budget, including termination of a Clinical Study due to a Safety Event; provided that (i) any conduct that would materially adversely affect the information AbbVie would receive in a Data Package and (ii) all Material Amendments to the Initial Development Plan and Budget (other than termination of a Clinical Study due to a Safety Event), in each case ((i) and (ii)) must be agreed to in writing by AbbVie and Cugene and neither Party shall have final decision-making authority with respect thereto.", "": "" }, { "Text": "(b) neither Party shall have final decision-making authority with respect to (i) approval of any amendment to IND, study protocol or other regulatory submission (excluding any administrative or scheduling communications or interactions) to be filed by Cugene pursuant to Section 2.3.2, (ii) approval of the GLP Toxicology Protocol or any amendments thereto, or (iii) approval of any submissions to Governmental Authorities (or decisions to decline to do so) with respect to the preparation, filing, prosecution and maintenance by Cugene of Product Patents pursuant to Section 8.2.1(b), which, in each case ((i) through (iii)), must be agreed to in writing by AbbVie and Cugene;", "": "" }, { "Text": "(c) all such decisions must be consistent with the terms of this Agreement and Applicable Law; and", "": "" }, { "Text": "(d) Disputes arising between the Parties in connection with or relating to this Agreement or any document or instrument delivered in connection herewith, and that are outside of the jurisdiction of the JGC or described in Section 6.1.2(k), shall be resolved pursuant to Section 13.5. For clarity, with respect to the matters set forth in the proviso of subsection (a) or in subsection (b) above, such matters shall remain deadlocked unless otherwise agreed by the Parties and are not subject to the dispute resolution set forth in Section 13.5 (for example, if the Parties cannot agree on a Material Amendment to the Initial Development Plan and Budget proposed by a Party, the Initial Development Plan and Budget will remain unchanged).", "": "" }, { "Text": "6.2.5. Limitations on Authority. Each Party shall retain the rights, powers, and discretion granted to it under this Agreement and no such rights, powers, or discretion shall be delegated to or vested in the JGC unless such delegation or vesting of rights is expressly provided for in this Agreement or the Parties expressly so agree in writing. The JGC shall not have the power to amend, modify, or waive compliance with this Agreement, which may only be amended or modified as provided in Section 13.8 or compliance with which may only be waived as provided in Section 13.11.", "": "" }, { "Text": "6.2.6. Discontinuation; Disbandment. The JGC shall continue to exist until the first to occur of: (a) the Parties mutually agreeing to disband the JGC, (b) the License Option Effective Date (provided that, if Cugene is required to perform any Unfinished Initial Development Activities after the License Option Effective Date under Section 3.3(a), the JGC shall continue to exist until completion of such Unfinished Initial Development Activities solely for the purpose of overseeing and deciding matters related thereto) and (c) AbbVie exercising its right to disband the JGC in the event of a Change in Control as set forth in Section 13.18. Upon the occurrence of any of the foregoing, (i) the JGC shall disband, have no further responsibilities or authority under this Agreement and shall be considered dissolved by the Parties and (ii) if JGC disbands as a result of subsection (a) or (c) above, any requirement of Cugene to provide Information or other materials to the JGC during the remaining License Option Period shall be deemed a requirement to provide such Information or other materials to AbbVie and AbbVie shall have the right to solely decide, without consultation with Cugene, all matters under the then-current Initial Development Plan and Budget, but, for clarity, shall not have the right to amend the then-current Initial Development Plan and Budget.", "": "" }, { "Text": "6.3. Working Groups. From time to time, the JGC may establish and delegate duties to other committees or directed teams (each, a \"Working Group\") on an \"as-needed\" basis to oversee particular projects or activities. Each such Working Group shall be constituted and shall operate as the JGC determines; provided that each Working Group shall have sufficient representation from each Party; provided, further, that each Working Group shall follow governance practices consistent with those applicable to the JGC except that any dispute between the representatives of each Party on a Working Group shall be referred to the JGC for resolution in accordance with Section 6.2.4 and the other terms and conditions of this Agreement. Working Groups may be established on an ad hoc basis for purposes of a specific project, for the term of the JGC or on such other basis as the JGC may determine. Each Working Group and its activities shall be subject to the oversight, review and approval of, and shall report to, the JGC. In no event shall the authority of the Working Group exceed that specified for the JGC in this ARTICLE 6.", "": "" }, { "Text": "6.4. Alliance Managers. Each Party shall appoint an individual who shall oversee contact between the Parties for all matters between meetings of the JGC, shall be the primary contacts between the Parties after disbandment of the JGC, and shall have such other responsibilities as the Parties may agree in writing after the Effective Date, which individual may be replaced at any time by notice in writing to the other Party (the \"Alliance Managers\"). The Alliance Managers shall work together to manage and facilitate the communication between the Parties under this Agreement, including the resolution (in accordance with the terms of this Agreement) of issues between the Parties that arise in connection with this Agreement. The Alliance Managers shall not have final decision-making authority with respect to any matter under this Agreement.", "": "" }, { "Text": "ARTICLE 7 PAYMENTS AND RECORDS", "": "" }, { "Text": "7.1. Upfront Payment. Subject to the terms and conditions of this Agreement, no later than 30 days after the Effective Date, AbbVie shall pay Cugene a non-refundable, non-creditable upfront amount equal to $48,500,000.", "": "" }, { "Text": "7.2. License Option Exercise Payment. If AbbVie delivers Cugene an Exercise Notice pursuant to Section 3.2.1, AbbVie shall pay to Cugene a one-time non-refundable, non-creditable payment of $40,000,000 (the \"License Option Exercise Payment\") within 30 days after the License Option Effective Date.", "": "" }, { "Text": "7.3. Development Milestone Events. Subject to the terms and conditions of this Agreement, with respect to each milestone event set forth in the table immediately below (each, a \"Development Milestone Event\"), AbbVie shall pay Cugene the corresponding non-refundable, non-creditable milestone payment set forth in such table (each, a \"Development Milestone Payment\") within 30 days after the date on which AbbVie or any of its Affiliates or its Sublicensees (other than with respect to Development Milestone Event #1, which may be achieved by or on behalf of Cugene or AbbVie) first achieves such Development Milestone Event for a Licensed Product:", "": "" }, { "Text": "Development Milestone Event", "": "" }, { "Text": "1. Initiation of the first Phase Ib Clinical Trial for a Licensed Product containing CUG252, as set forth the Initial Development Plan and Budget for such Licensed Product following Successful Completion of the Phase Ia Clinical Trial", "": "" }, { "Text": "1.1. Initiation of the first Phase II Clinical Trial sponsored by AbbVie or any of its Affiliates or Sublicensees for a Different Licensed Product", "": "" }, { "Text": "2. Initiation of the first Registrational Trial sponsored by AbbVie or any of its Affiliates or Sublicensees for a Licensed Product", "": "" }, { "Text": "3. Initiation of the first Registrational Trial sponsored by AbbVie or any of its Affiliates or Sublicensees for a Licensed Product for an Indication other than the Indication for the Registrational Trial that achieved Development Milestone Event #2", "": "" }, { "Text": "4. Acceptance of a BLA for a Licensed Product by the FDA", "": "" }, { "Text": "5. First Commercial Sale of a Licensed Product in the United States", "": "" }, { "Text": "6. First Commercial Sale of a Licensed Product in any Major European Market", "": "" }, { "Text": "Except as follows, each Development Milestone Event in this Section 7.3 shall be payable once. If, after the First Commercial Sale of a Licensed Product that contains CUG252 in the United States, any Development Milestone Event (other than the Development Milestone Events #1 and #1.1) is achieved for the second time by a Licensed Product that contains a Licensed Therapeutic other than CUG252 (a \"Different Licensed Product\"), then, within 30 days after such achievement, AbbVie shall pay Cugene an amount equal to: (a) if such Different Licensed Product is claimed by either a Bispecific Patent or a Vitokine Patent, 100% of the corresponding Development Milestone Payment and (b) if such Different Licensed Product is not claimed by either a Bispecific Patent or a Vitokine Patent, 50% of the corresponding Development Milestone Payment. For clarity, for any Development Milestone Event that is achieved for the first time by a Licensed Product (regardless of whether such Licensed Product is a Licensed Product containing CUG252 or a Different Licensed Product), AbbVie shall pay Cugene an amount equal to 100% of the corresponding Development Milestone Payment within 30 days after such achievement. In addition, if any Development Milestone Event (other than the Development Milestone Events #1 and #1.1) is achieved for the second time by a Different Licensed Product before the First Commercial Sale of a Licensed Product that contains CUG252 in the United States, then within 30 days after the First Commercial Sale of a Licensed Product that contains CUG252 in the United States, the corresponding Development Milestone Payments for all such Development Milestone Events that were achieved by such Different Licensed Product before such First Commercial Sale shall be paid. The maximum aggregate amount of Development Milestone Payments payable under this Section 7.3 by AbbVie is $375,000,000.", "": "" }, { "Text": "Development Milestone Events are determined as of the Initiation of a Clinical Study; provided that if a Clinical Study does not meet the criteria for a Phase Ib (or II, as applicable) Clinical Trial or Registrational Trial, as applicable, at the time such Clinical Study is Initiated, but is later modified based on interim analyses to satisfy the criteria of a Phase Ib (or II, as applicable) Clinical Trial or Registrational Trial, as applicable, such Development Milestone Event shall be deemed achieved upon such criteria are satisfied. In addition, if Development Milestone Event #1 is skipped, it will be deemed to be achieved as of the earlier of: (a) Initiation of the first Phase II Clinical Trial sponsored by AbbVie or any of its Affiliates or Sublicensees for a Licensed Product and (b) when Development Milestone Event #2 is achieved or deemed to be achieved; if Development Milestone Event #1.1 is skipped, it will be deemed to be achieved when Development Milestone Event #2 is achieved or deemed to be achieved with respect to the relevant Different Licensed Product; and if Development Milestone Event #2 is skipped, it will be deemed to be achieved when Development Milestone Event #4, #5 or #6 is achieved.", "": "" }, { "Text": "7.4. Sales Milestone Events. Subject to the terms and conditions of this Agreement, with respect to each milestone event set forth set forth in the table immediately below (each, a \"Sales Milestone Event\"), AbbVie shall pay Cugene the corresponding non-refundable, non-creditable milestone payment set forth in such table (each, a \"Sales Milestone Payment\") within 60 days after the end of the Calendar Year in which such Sales Milestone Event for a Licensed Product is achieved:", "": "" }, { "Text": "Sales Milestone Event", "": "" }, { "Text": "1. The first Calendar Year in which aggregate Net Sales of such Licensed Product in the Territory exceed $500,000,000", "": "" }, { "Text": "2. The first Calendar Year in which aggregate Net Sales of such Licensed Product in the Territory exceed $1,000,000,000", "": "" }, { "Text": "3. The first Calendar Year in which aggregate Net Sales of such Licensed Product in the Territory exceed $2,000,000,000", "": "" }, { "Text": "4. The first Calendar Year in which aggregate Net Sales of such Licensed Product in the Territory exceed $3,000,000,000", "": "" }, { "Text": "Each Sales Milestone Payment in this Section 7.4 shall be payable only upon the first achievement of the applicable Sales Milestone Event and not for any other subsequent achievement by the same or another Licensed Product. For clarity, the Sales Milestone Payments shall be additive such that if multiple Sales Milestone Events are achieved in the same Calendar Year, then the Sales Milestone Payments for all such Sales Milestone Events shall be payable with respect to such Calendar Year. The maximum aggregate amount of Sales Milestone Payments payable under this Section 7.4 by AbbVie is $650,000,000.", "": "" }, { "Text": "7.5. Royalties.", "": "" }, { "Text": "7.5.1. Royalty Rates. Subject to Section 7.5.3 and Section 7.5.4, commencing on the beginning of the Royalty Term with respect to a Licensed Product in the Territory, on a Licensed Product-by-Licensed Product basis, AbbVie shall pay Cugene a non-refundable, non-creditable royalty on Net Sales of such Licensed Product in the Territory (excluding Net Sales of such Licensed Product in any country or other jurisdiction in the Territory for which the Royalty Term for such Licensed Product in such country or other jurisdiction has expired) during each Calendar Year at the following rates:", "": "" }, { "Text": "Aggregate Net Sales of such Licensed Product in the Territory in a Calendar Year", "": "" }, { "Text": "For that portion of aggregate Net Sales of such Licensed Product in the Territory in a Calendar Year that is less than $1,000,000,000", "": "" }, { "Text": "For that portion of aggregate Net Sales of such Licensed Product in the Territory in a Calendar Year that is greater than or equal to $1,000,000,000 but less than $3,000,000,000", "": "" }, { "Text": "For that portion of aggregate Net Sales of such Licensed Product in the Territory in a Calendar Year that is equal to or greater than $3,000,000,000", "": "" }, { "Text": "7.5.2. Royalty Term. AbbVie's obligation to pay Cugene royalties with respect to a Licensed Product, on a Licensed Product-by-Licensed Product and country-by-country basis (or jurisdiction-by-jurisdiction basis), shall commence on the beginning of the Royalty Term with respect to such Licensed Product in such country or other jurisdiction and shall end at the expiration of the Royalty Term for such Licensed Product in such country or other jurisdiction.", "": "" }, { "Text": "7.5.3. Royalty Rate Reductions. Notwithstanding Section 7.5.1, but subject to Section 7.5.2 and Section 7.5.5, if:", "": "" }, { "Text": "(a) from and after the date on which a Licensed Product is sold in a country or other jurisdiction in the Territory and is not Covered by a Royalty Claim in such country or other jurisdiction during the Royalty Term for such Licensed Product in such country or other jurisdiction, the royalty rate for such Licensed Product set forth in Section 7.5.1 with respect to such country or other jurisdiction shall be reduced by 50%; and", "": "" }, { "Text": "(b) if in any country or other jurisdiction in the Territory during the Royalty Term in such country or other jurisdiction for a Licensed Product a Biosimilar Product with respect to such Licensed Product is launched in such country or other jurisdiction, then, for so long as the Net Sales of such Licensed Product in such country or jurisdiction in a Calendar Quarter is at least 30% less than the Net Sales of such Licensed Product in such country or jurisdiction in the last full Calendar Quarter immediately prior to the Calendar Quarter in which such Biosimilar Product was first sold in such country or jurisdiction, the royalty rate for such Licensed Product set forth in Section 7.5.1 with respect to such country or other jurisdiction shall be reduced by 50%.", "": "" }, { "Text": "7.5.4. Third Party Payments. Subject to Section 7.5.5(b), if (a) AbbVie enters into an agreement with a Third Party in order to obtain a license or right under a Patent or Information owned or controlled by such Third Party that, absent a license thereunder, would be infringed by the sale, use, or Manufacture of a Licensed Product in a country or jurisdiction, or (b) AbbVie incurs any reasonable out-of-pocket costs and expenses in defending or settling any Third Party Infringement Claim (including pursuant to any adverse judgment in connection therewith) for activities related to a Licensed Therapeutic or Licensed Product conducted in a country or jurisdiction pursuant to Section 8.4, in each case (a) and (b), AbbVie shall be entitled to deduct from any royalties payable under Section 7.5 for Net Sales of such Licensed Product in such country or jurisdiction a Calendar Quarter 50% of all upfront payments, milestone payments, royalties and other amounts that would be owed to such Third Party under such license on account of the sale of such Licensed Product in such country or jurisdiction during such Calendar Quarter (in each case, prior to the application of any stacking provision in any such agreement) and 50% of any such out-of-pocket costs and expenses borne by AbbVie in defending or settling the Third Party Infringement Claim for activities related to a Licensed Therapeutic or Licensed Product conducted in such country or jurisdiction, as applicable (\"Third Party Payments\"); provided that (i) with respect to any Third Party Payments attributed to Cugene's breach of any of its representations and warranties hereunder, as acknowledged by Cugene or determined by dispute resolution procedure pursuant to Section 13.5, AbbVie shall be entitled to deduct 100% of such Third Party Payments; and (ii) for each Third Party Payment due to a Third Party that is not specific to a Licensed Product (e.g., the upfront payment or license maintenance fee is in consideration for a license covering a Licensed Product and one or more products that are not a Licensed Product), AbbVie shall only be entitled to deduct 50% of such portion of the Third Party Payment as is reasonably attributable to the Licensed Product (provided that if subsection (i) above applies, 100% of such portion may be deducted). Notwithstanding anything to the contrary, (A) with respect to any Combination Product, if (i) the license under the applicable Patent or Information owned or controlled by a Third Party obtained is due to the Other Active(s) or (ii) AbbVie incurs out-of-pocket costs and expenses in defending or settling Third Party Infringement Claim related to the Other Active(s), or (B) with respect to any Licensed Therapeutic that is a bispecific or multi-specific molecule, if (i) the license under the applicable Patent or Information owned or controlled by a Third Party obtained is due to the binding domain(s) other than the IL-2 domain of such Licensed Therapeutic or (ii) AbbVie incurs out-of-pocket costs and expenses in defending or settling Third Party Infringement Claim related to the binding domain(s) other than the IL-2 domain of such Licensed Therapeutic, then, in each case of (A) and (B), AbbVie shall not be entitled to the foregoing deduction with respect to such license or out-of-pocket costs and expenses in defending or settling such Third Party Infringement Claim related to the Other Active(s) or binding domain(s) other than the IL-2 domain of the applicable Licensed Therapeutic, as applicable.", "": "" }, { "Text": "7.5.5. Mechanics of Royalty Adjustments.", "": "" }, { "Text": "(a) Any reductions set forth in Section 7.5.3 shall be applied to the royalty rates payable to Cugene under Section 7.5.1 in the order in which the event triggering such reduction occurs. For purposes of Section 7.5.3, the portion of Net Sales of the applicable Licensed Product in each country or other jurisdiction subject to each of the royalty rates under Section 7.5.1 shall be proportional to Net Sales of such Licensed Product in all countries and jurisdictions in the Territory subject to the applicable royalty rates under Section 7.5.1. Schedule 7.5 contains an example calculation of royalties payable on Net Sales of a Licensed Product with the reductions contemplated by Section 7.5.3(b). The example set forth on Schedule 7.5 is for illustrative purposes only.", "": "" }, { "Text": "(b) In no event shall the royalties payable to Cugene under Section 7.5.1, as applicable, for Net Sales of a particular Licensed Product in a country or jurisdiction in a Calendar Quarter be reduced by more than 50% of what would otherwise be payable for such Licensed Product in such country or jurisdiction in such Calendar Quarter as a result of the reductions set forth in Section 7.5.3 or Section 7.5.4; provided that such cap on royalty reductions shall not apply to reductions that result from Third Party Payments attributed to Cugene's breach of a representation or warranty hereunder, as acknowledged by Cugene or determined by dispute resolution procedure pursuant to Section 13.5. Credits for deductions pursuant to Section 7.5.4 not exhausted in any Calendar Quarter may be carried into future Calendar Quarters, subject to the preceding sentence.", "": "" }, { "Text": "7.6. Estimated Sales Levels. Cugene acknowledges and agrees that the sales levels set forth in Section 7.4 and Section 7.5.1 shall not be construed as representing an estimate or projection of anticipated sales of the Licensed Products, or implying any level of diligence or Commercially Reasonable Efforts, in the Territory and that the sales levels set forth in Section 7.4 and Section 7.5.1 are merely intended to define AbbVie's royalty and other payment obligations, as applicable, if such sales levels are achieved.", "": "" }, { "Text": "7.7. Royalty Payments and Reports. AbbVie shall calculate all amounts payable to Cugene pursuant to Section 7.5 at the end of each Calendar Quarter, which amounts shall be converted to Dollars, in accordance with Section 7.8. AbbVie shall pay to Cugene the royalty amounts due with respect to a given Calendar Quarter within 90 days after the end of such Calendar Quarter. Each payment of royalties due to Cugene shall be accompanied by a written report setting forth (a) the amount of Net Sales of each Licensed Product in each country or other jurisdiction in the Territory during the applicable Calendar Quarter (including such amounts expressed in local currency and as converted to Dollars), (b) the amount of gross sales of each Licensed Product in each country or other jurisdiction in the Territory and a high-level aggregated reconciliation to Net Sales of such Licensed Product, (c) the applicable royalty rates for each Licensed Product in each country or jurisdiction after applying any permitted deductions under this Agreement; and (d) a calculation of the amount of royalty payment due on such Net Sales for such Calendar Quarter. For clarity, if two or more Licensed Products have achieved the first Net Sale, the report provided by AbbVie pursuant to this Section 7.7 will be provided on a Licensed Product-by-Licensed Product basis.", "": "" }, { "Text": "7.8. Mode of Payment. All payments to either Party under this Agreement shall be made by deposit of Dollars in the requisite amount to such bank account as the payee Party may from time to time designate by notice to the payor Party. For the purpose of calculating any amounts due under, or otherwise reimbursable pursuant to, this Agreement, a Party shall convert any amount expressed in a foreign currency into Dollar equivalents using its, its Affiliate's or (sub)licensee's standard conversion methodology consistent with the Accounting Standards.", "": "" }, { "Text": "7.9. Taxes.", "": "" }, { "Text": "7.9.1. Income Taxes. Each Party shall be solely responsible for the payment of all taxes imposed on its share of income arising directly or indirectly from the activities of the Parties under this Agreement.", "": "" }, { "Text": "7.9.2. Withholding Taxes. If any sum due to be paid to either Party hereunder is or would otherwise be subject to any withholding or similar tax, the Parties shall cooperate with each other and use their commercially reasonable efforts to do all such acts and things and to sign all such documents as will enable them to secure any available exemption from, reduction in, or refund of such tax, including by taking advantage of any applicable double taxation agreement or treaty. If there is no applicable exemption from such withholding or similar tax, the payor Party shall remit such withholding or similar tax to the appropriate Governmental Authority, deduct the amount paid from the amount due to the payee Party and secure and send to the payee Party the best available evidence of the payment of such withholding or similar tax. Any such amounts deducted by the payor Party in respect of such withholding or similar tax shall be treated as having been paid by the payor Party for purposes of this Agreement. If a Governmental Authority retroactively determines that a payment made by the payor Party to the payee Party pursuant to this Agreement should have been subject to withholding or similar (or to additional withholding or similar) taxes, and such payor Party (the \"Withholding Party\") remits such withholding or similar taxes to the Governmental Authority, including any interest and penalties that may be imposed thereon (together with the tax paid, the \"Withholding Amount\"), the Withholding Party shall have the right to (a) offset the Withholding Amount against future payment obligations of the Withholding Party under this Agreement, (b) invoice the payee Party for the Withholding Amount (which shall be payable by the other Party within 60 days of its receipt of such invoice) or (c) pursue reimbursement through any other available remedy.", "": "" }, { "Text": "7.9.3. Indirect Taxes. All payments are exclusive of value added taxes, sales taxes, consumption taxes and other similar taxes (the \"Indirect Taxes\") which shall be borne by the paying Party. If any Indirect Taxes are chargeable in respect of any payments, the paying Party shall pay such Indirect Taxes at the applicable rate in respect of such payments following receipt, where applicable, of an Indirect Taxes invoice in the appropriate form issued by the receiving Party in respect of those payments. The Parties shall issue invoices for all amounts payable under this Agreement consistent with Indirect Tax requirements and irrespective of whether the sums may be netted for settlement purposes. If the Indirect Taxes originally paid or otherwise borne by the paying Party are in whole or in part subsequently determined not to have been chargeable, the receiving Party shall use commercially reasonable efforts to take all necessary steps to receive a refund of these undue Indirect Taxes from the applicable Governmental Authority or other fiscal authority and any amount of undue Indirect Taxes repaid by such authority to the payee Party shall be transferred to the payor Party within 45 days of receipt.", "": "" }, { "Text": "7.9.4. Taxes Resulting from a Paying Party's Action. Notwithstanding anything to the contrary, if, following the Effective Date of this Agreement, the payee Party (a) changes the Person making payments, (b) re-domiciles to a jurisdiction other than the jurisdiction of such Party's domicile as of the Effective Date, or (c) transfers or assigns this Agreement (or if its assignee pursuant to Section 13.3 is domiciled at the time of such assignment, or subsequently re-domiciles to a jurisdiction other than the jurisdiction of such Party's domicile as of the Effective Date), and if as a result of such action, the payee Party is required by Applicable Law to withhold taxes in respect of any amount payable under this Agreement payable by such Party, and such withholding taxes exceed the amount of withholding taxes that would have been applicable if such action had not occurred, then the sum payable shall be increased to take into account such increased withholding taxes as may be necessary so that, after making all required withholdings, the Party receiving payment receives an amount equal to the sum it would have received had no such increase in withholding been made; provided, however, the paying Party will have no obligation to pay any additional amount under the immediately preceding clause (x) to the extent the Party entitled to receive payment obtains a refund or exemption of such additional amounts, (y) if the Party entitled to receive payment has the ability to offset such withheld amounts against other tax liabilities such Party has in the applicable jurisdiction and such amounts are actually so offset, or (z) if such increased withholding tax would not have been imposed but for the action(s) by the payee Party described above in subsection (a), (b) or (c).", "": "" }, { "Text": "7.10. Interest on Late Payments. If any payment due to either Party under this Agreement is not paid when due, then the payor Party shall pay interest thereon (before and after any judgment) at an annual rate (but with interest accruing on a daily basis) of 100 basis points above SOFR, such interest to run from the date on which payment of such amount became due until payment thereof in full together with such interest.", "": "" }, { "Text": "7.11. Financial Records. AbbVie shall, and shall cause its Affiliates and its and their Sublicensees to, keep complete and accurate financial books and records pertaining to Net Sales to the extent required to calculate and verify all amounts payable hereunder. AbbVie shall, and shall cause its Affiliates and its and their Sublicensees to, retain such books and records until the later of (a) three years after the end of the period to which such books and records pertain and (b) the expiration of the applicable tax statute of limitations (or any extensions thereof) or for such longer period as may be required by Applicable Law.", "": "" }, { "Text": "7.12. Audit.", "": "" }, { "Text": "7.12.1. Procedures. At the request of Cugene, AbbVie shall, and shall cause its Affiliates and its and their Sublicensees to, permit an independent auditor designated by Cugene and reasonably acceptable to AbbVie, at reasonable times and upon reasonable notice, to audit the books and records maintained pursuant to Section 7.11 to ensure the accuracy of all reports and payments made hereunder. Such audits may not (a) be conducted for any Calendar Quarter more than three years after the end of such Calendar Quarter, (b) be conducted more than once in any 12-month period (unless a previous audit during such 12-month period revealed an underpayment with respect to such period) or (c) be repeated for any Calendar Quarter. The accounting firm shall disclose only whether the reports are correct or not and the specific details concerning any discrepancies. No other information shall be shared. The cost of any audit shall be borne by Cugene, unless the audit reveals a variance of more than the greater of (i) 5% from the reported amounts and (ii) $500,000, in which case AbbVie shall bear the cost of such audit. Unless disputed pursuant to Section 7.12.2, if an audit concludes that (x) additional amounts were owed by AbbVie, then AbbVie shall pay the additional amounts, with interest from the date originally due as provided in Section 7.10 or (y) excess payments were made by AbbVie, then Cugene shall reimburse such excess payments, in either case ((x) or (y)), within 60 days after the date on which such audit is completed.", "": "" }, { "Text": "7.12.2. Audit Dispute. If there is a dispute with respect to any audit under Section 7.12, Cugene and AbbVie shall work in good faith to resolve the dispute. If the Parties are unable to reach a mutually acceptable resolution of any such dispute within 30 days after one Party notifies the other Party of such dispute, the Parties shall submit such dispute for resolution to a certified public accounting firm jointly selected by each Party's certified public accountants or to such other Person as the Parties shall mutually agree (the \"Auditor\"). The decision of the Auditor shall be final and the costs of such resolution as well as the initial audit shall be borne between the Parties in such manner as the Auditor shall determine. Not later than ten days after such decision and in accordance with such decision, AbbVie shall pay the additional amounts, with interest from the date originally due as provided in Section 7.10, or Cugene shall reimburse the excess payments, as applicable.", "": "" }, { "Text": "7.12.3. Confidentiality. Cugene shall treat all information subject to review under this ARTICLE 7 in accordance with the confidentiality provisions of ARTICLE 9. AbbVie shall not be obligated to provide any information to the independent auditor pursuant to Section 7.12.1 or the Auditor pursuant to Section 7.12.2, until the independent auditor or the Auditor, as applicable, has entered into a reasonably acceptable confidentiality agreement with AbbVie obligating such independent auditor or the Auditor, as applicable, to retain all such financial information in confidence pursuant to such confidentiality agreement.", "": "" }, { "Text": "7.13. Right to Offset. Each Party shall have the right to offset any amount owed by the other Party to such first Party under or in connection with this Agreement against any payments owed by such first Party to such other Party under this Agreement. Such offsets shall be in addition to any other rights or remedies available under this Agreement and Applicable Law.", "": "" }, { "Text": "7.14. Diagnostic and Veterinary Products. The milestones and royalties in this ARTICLE 7 shall not apply to the Development and Commercialization of Licensed Products for diagnostic, veterinary or any other non-human use or for uses solely for screening patients who have been diagnosed with a disease, state or condition for eligibility to be treated for such disease, state or condition with a Licensed Product or for monitoring patients who are or have been treated with a Licensed Product; provided that if AbbVie intends to Develop or Commercialize Licensed Products for diagnostic, veterinary or any other non-human use or for uses solely for screening patients who have been diagnosed with a disease, state or condition for eligibility to be treated for such disease, state or condition with a Licensed Product or for monitoring patients who are or have been treated with a Licensed Product, the Parties shall negotiate in good faith and agree to milestones or royalties to be paid by AbbVie with respect to such Development and Commercialization.", "": "" }, { "Text": "7.15. No Other Compensation. Neither Party previously has paid or entered into any other commitment to pay, whether orally or in writing, any of the other Party's employees, directly or indirectly, any consideration, compensation, or benefits, monetary or otherwise, in connection with the transaction contemplated herein.", "": "" }, { "Text": "7.16. No Limitation. Nothing contained in this ARTICLE 7 shall in any way limit AbbVie's or Cugene's right to indemnification under this Agreement or to otherwise recover damages for breach of this Agreement.", "": "" }, { "Text": "7.17. Financial Obligations Under WuXi Agreements. All financial obligations, including royalties, due from Cugene to Third Parties for or in respect of a Licensed Therapeutic or a Licensed Product arising under the WuXi Agreement or any Included In-License Agreement are the responsibility of Cugene.", "": "" }, { "Text": "ARTICLE 8 INTELLECTUAL PROPERTY", "": "" }, { "Text": "8.1. Ownership of Intellectual Property.", "": "" }, { "Text": "8.1.1. Ownership of IP. Subject to the license grants and other rights herein as between the Parties, each Party shall own and retain all right, title and interest in and to any and all (a) Information and inventions that are conceived, discovered, developed or otherwise made by or on behalf of such Party (or its Affiliates or its or their (sub)licensees/Sublicensees) under or in connection with this Agreement, whether or not patented or patentable, and any and all Patents and other intellectual property rights with respect thereto, except to the extent that any such Information or invention or any Patent or intellectual property right with respect thereto is Joint Know-How or Joint Patents and (b) other Information, inventions, Patents, and other intellectual property rights that are owned or otherwise Controlled by such Party, its Affiliates, or its or their licensees or (sub)licensees/Sublicensees (other than the other Party and its Affiliates and its and their licensees and (sub)licensees/Sublicensees). For clarity, and for the purpose of ARTICLE 8, AbbVie, its Affiliates and its or their Sublicensees shall not be considered a (sub)licensee of Cugene or its Affiliates.", "": "" }, { "Text": "8.1.2. Ownership of Joint IP. As between the Parties, each Party shall each own an equal, undivided interest in any and all: (a) (i) Information and inventions that are conceived, discovered, developed or otherwise made under or in connection with this Agreement or the MTA jointly by or on behalf of Cugene or its Affiliates or its or their (sub)licensees, on the one hand, and AbbVie or its Affiliates, on the other hand, in connection with the work conducted under or in connection with this Agreement during the Term or the MTA, or (ii) Information and inventions that are conceived, discovered, developed or otherwise made under or in connection with the MTA solely by or on behalf of AbbVie or its Affiliates in connection with the work conducted under or in connection with the MTA, in each case of (i) and (ii), whether or not patented or patentable (collectively, the \"Joint Know-How\"); and (b) Patents (the \"Joint Patents\") and other intellectual property rights with respect to the Information and inventions described in clause (a) (together with Joint Know-How and Joint Patents, the \"Joint IP\"); provided that, notwithstanding the foregoing, any Information and inventions that are conceived, discovered, developed or otherwise made under or in connection with this Agreement jointly by or on behalf of Cugene or its Affiliates or its or their (sub)licensees, on the one hand, and AbbVie or its Affiliates, on the other hand, under this Agreement during the Term that are related to the AbbVie Liquid Formulation and the Patent and other intellectual property rights with respect to such Information and inventions shall be solely owned by AbbVie. Each Party shall promptly disclose to the other Party in writing and shall cause its Affiliates, and its and their (sub)licensees (if applicable) to so disclose, the conception, discovery, development, or making of any Joint Know-How or Joint Patents. Subject to the licenses granted under Section 4.1 and Section 12.4 and the exclusivity obligations of Cugene under Section 4.6, (x) each Party shall have the right to practice, grant licenses under, and transfer any Joint IP, (y) neither Party shall have any obligation to account to the other for profits or to obtain any approval of the other Party to license or Exploit any Joint IP by reason of joint ownership thereof, and (z) each Party hereby waives any right it may have under the laws of any jurisdiction to require any such consent or accounting.", "": "" }, { "Text": "8.1.3. United States Law. The determination of whether Information and inventions are conceived, discovered, developed or otherwise made by or on behalf of a Party for the purpose of allocating proprietary rights (including Patent, copyright, or other intellectual property rights) therein, shall, for purposes of this Agreement, be made in accordance with Applicable Law in the United States (without regard to conflict of laws) as such law exists as of the Effective Date irrespective of where such conception, discovery, development, or making occurs. If United States law otherwise would not apply to the discovery, generation, creation or conception any Information hereunder, each Party shall, and does hereby, assign, and shall cause its Affiliates and its and their licensees and (sub)licensees/Sublicensees to so assign, to the other Party, without additional compensation, such right, title and interest in and to any Information as well as any intellectual property rights with respect thereto, as is necessary to fully effect, as applicable, (a) the sole ownership provided for in Section 8.1.1 or Section 8.1.2 and (b) the joint ownership provided for in Section 8.1.2.", "": "" }, { "Text": "8.1.4. Assignment Obligation. Each Party shall cause all Persons who perform Development activities, Manufacturing activities or regulatory activities for such Party under this Agreement to be under an obligation to assign (or, if such Party is unable to cause such Person to agree to such assignment obligation despite such Party's using commercially reasonable efforts to negotiate such assignment obligation, provide a license under) their rights in any Information and inventions resulting therefrom to such Party, except if Applicable Law requires otherwise and except in the case of governmental, not-for-profit, and public institutions that have standard policies against such an assignment (in which case a suitable license, or right to obtain such a license, shall be obtained). Each Party shall, and does hereby, assign, and shall cause its Affiliates and its and their (sub)licensees/Sublicensees to so assign, to the other Party, without additional compensation, such right, title, and interest in and to any Information and inventions as well as any intellectual property rights with respect thereto, as is necessary to fully effect (a) the sole ownership provided for in Section 8.1.1 and (b) the joint ownership provided for in Section 8.1.2.", "": "" }, { "Text": "8.1.5. Control of Intellectual Property. Neither Party shall, and each Party shall cause its Affiliates not to, enter into or amend any agreement with a Third Party, or include in any such agreement or amendment any restrictive provisions, with an intent to limit its Control of, or to not Control, any Information, invention, Patent or other intellectual property right that would be subject to the license grants in Section 4.1 or Section 4.2 in the absence of such agreement, amendment or restrictive provisions. Further, when entering into any agreement or amendment with a Third Party relating to any Information, Patents or other intellectual property rights that, if Controlled by a Party or its Affiliates, would be subject to the license grants in Section 4.1 or Section 4.2, each Party shall use good faith efforts to obtain Control of such Information, invention, Patents and other intellectual property rights.", "": "" }, { "Text": "8.2. Prosecution and Maintenance of Patents.", "": "" }, { "Text": "8.2.1. Cugene Patents Prior to the License Option Effective Date. The following provisions shall apply with respect to Cugene Patent prosecution and maintenance prior to the License Option Effective Date:", "": "" }, { "Text": "(a) Other Cugene Patents. Cugene shall have the sole right, except with respect to any Mixed Cugene Patents in which case Cugene shall have the first right, but, in each case, but not the obligation, through the use of outside counsel reasonably acceptable to AbbVie, to prepare, file, prosecute, and maintain the Other Cugene Patents worldwide and to conduct any opposition, re-issuance, post-grant review, inter-partes review, reexamination request, nullity action, interference, or other similar post-grant proceedings and any appeals therefrom (each, a \"Defense Proceeding\") relating thereto (except that in connection with any actions subject to Section 8.3, the Party with responsibility for such action pursuant to Section 8.3 shall have responsibility for such Defense Proceedings), at Cugene's sole cost and expense; provided that Cugene shall consult with AbbVie with respect to any submission (or declining to make any submission) to a Governmental Authority to prepare, file, prosecute, or maintain any Mixed Cugene Patent and not unreasonably reject AbbVie's comments with respect thereto. Notwithstanding the foregoing, Cugene shall promptly inform AbbVie of any adversarial patent office proceeding or sua sponte filing, including a request for, or filing or declaration of, any interference, opposition, or reexamination relating to any Mixed Cugene Patent in the Territory. The Parties shall thereafter consult and cooperate to determine a course of action with respect to any such proceeding in the Territory and Cugene shall consider in good faith all comments, requests, and suggestions provided by AbbVie. Upon request by AbbVie and in consultation with AbbVie, Cugene shall (i) prepare, file, prosecute, and maintain Mixed Cugene Patents in a manner that will generate Product Patent(s), including by filing divisionals, continuations, continuations-in-part or otherwise, so as to, to the extent feasible, separate into discrete Patents that claim Licensed Therapeutics and the Licensed Products or the Exploitation thereof and do not claim any other therapeutic or products or the Exploitation thereof and (ii) consider in good faith and not unreasonably reject any comments of AbbVie on all potential filings of Cugene pursuant to clause (i) of this sentence. If Cugene decides not to prepare, file, prosecute, or maintain, or not to initiate or continue any Defense Proceeding relating to any claim of a Mixed Cugene Patent in a country or other jurisdiction in the Territory, Cugene shall provide reasonable prior written notice to AbbVie of such intention (which notice shall, in any event, be given no later than 60 days prior to the next deadline for any action that may be taken with respect to such claims of such Mixed Cugene Patent in such country or other jurisdiction), and AbbVie shall thereupon have the option, in its sole discretion, to assume the control and direction of the preparation, filing, prosecution, and maintenance of such claims of such Mixed Cugene Patent or the Defense Proceeding, as applicable, at AbbVie's expense in such country or other jurisdiction.", "": "" }, { "Text": "(b) Product Patents. In consultation with AbbVie, Cugene shall have the first right, but not the obligation, through the use of outside counsel reasonably acceptable to AbbVie, to prepare, file, prosecute, and maintain the Product Patents worldwide and to conduct any Defense Proceeding relating thereto (except that in connection with any actions subject to Section 8.3, the Party with responsibility for such action pursuant to Section 8.3 shall have responsibility for such Defense Proceedings), at Cugene's sole cost and expense; provided that Cugene shall not make any submissions to (or specifically decline to do so) a Governmental Authority to prepare, file, prosecute, or maintain any Product Patent that have not been approved by the JGC. Notwithstanding the foregoing, Cugene shall promptly inform AbbVie of any adversarial patent office proceeding or sua sponte filing, including a request for, or filing or declaration of, any interference, opposition, or reexamination relating to a Product Patent in the Territory. The Parties shall thereafter consult and cooperate to determine a course of action with respect to any such proceeding in the Territory and Cugene shall consider in good faith all comments, requests, and suggestions provided by AbbVie. If Cugene decides not to prepare, file, prosecute, or maintain, or not to initiate or continue any Defense Proceeding relating to a Product Patent in a country or other jurisdiction in the Territory, Cugene shall provide reasonable prior written notice to AbbVie of such intention (which notice shall, in any event, be given no later than 60 days prior to the next deadline for any action that may be taken with respect to such Product Patent in such country or other jurisdiction), and AbbVie shall thereupon have the option, in its sole discretion, to assume the control and direction of the preparation, filing, prosecution, and maintenance of such Product Patent or the Defense Proceeding, as applicable, at AbbVie's expense in such country or other jurisdiction.", "": "" }, { "Text": "(c) Cugene shall keep AbbVie fully informed of all material steps with regard to the preparation, filing, prosecution, and maintenance of, and any Defense Proceeding relating to, the Product Patents or Mixed Cugene Patents, including by providing AbbVie with a copy of material filings and communications to and from any patent authority in the Territory regarding any Product Patent or Mixed Cugene Patents, and by providing AbbVie drafts of any material filings or responses (including copies of the text of the applications) to be made to such patent authorities in the Territory sufficiently in advance of submitting such filings or responses so as to allow for a reasonable opportunity for AbbVie to review and comment thereon.", "": "" }, { "Text": "8.2.2. Cugene Patents After the License Option Effective Date. The following provisions shall apply with respect to Cugene Patent prosecution and maintenance after the License Option Effective Date:", "": "" }, { "Text": "(a) Other Cugene Patents. Cugene shall have the sole right, except with respect to any Mixed Cugene Patents in which case Cugene shall have the first right, but, in each case, not the obligation, through the use of outside counsel reasonably acceptable to AbbVie, to prepare, file, prosecute, and maintain the Other Cugene Patents worldwide and to conduct any Defense Proceeding relating thereto (except that in connection with any actions subject to Section 8.3, the Party with responsibility for such action pursuant to Section 8.3 shall have responsibility for such Defense Proceedings), at Cugene's sole cost and expense; provided that Cugene shall not make any submissions (or specifically decline to do so) to a Governmental Authority to prepare, file, prosecute or maintain any claims of any Mixed Cugene Patent that have not been approved by AbbVie. Notwithstanding the foregoing, Cugene shall promptly inform AbbVie of any adversarial patent office proceeding or sua sponte filing, including a request for, or filing or declaration of, any interference, opposition, or reexamination relating to any Mixed Cugene Patent in the Territory. The Parties shall thereafter consult and cooperate to determine a course of action with respect to any such proceeding in the Territory and Cugene shall consider in good faith all comments, requests, and suggestions provided by AbbVie. Upon request by AbbVie and in consultation with AbbVie, Cugene shall (i) prepare, file, prosecute, and maintain Mixed Cugene Patents in a manner that will generate Product Patent(s), including by filing divisionals, continuations, continuations-in-part or otherwise, so as to, to the extent feasible, separate into discrete Patents that claim Licensed Therapeutics and the Licensed Products or the Exploitation thereof and do not claim any other therapeutic or products or the Exploitation thereof and (ii) consider in good faith and not unreasonably reject any comments of AbbVie on all potential filings of Cugene pursuant to clause (i) of this sentence. If Cugene decides not to prepare, file, prosecute, or maintain, or not to initiate or continue any Defense Proceeding relating to any claim of a Mixed Cugene Patent in a country or other jurisdiction in the Territory, Cugene shall provide reasonable prior written notice to AbbVie of such intention (which notice shall, in any event, be given no later than 60 days prior to the next deadline for any action that may be taken with respect to such claims of such Mixed Cugene Patent in such country or other jurisdiction), and AbbVie shall thereupon have the option, in its sole discretion, to assume the control and direction of the preparation, filing, prosecution, and maintenance of such claims of such Mixed Cugene Patent or the Defense Proceeding, as applicable, at AbbVie's expense in such country or other jurisdiction.", "": "" }, { "Text": "(b) Product Patents. AbbVie shall have the first right, but not the obligation, through the use of internal or outside counsel reasonably acceptable to Cugene, to prepare, file, prosecute, and maintain the Product Patents worldwide and to conduct any Defense Proceeding relating thereto (except that in connection with any actions subject to Section 8.3, the Party with responsibility for such action pursuant to Section 8.3 shall have responsibility for such Defense Proceedings), at AbbVie's sole cost and expense. Notwithstanding the foregoing, AbbVie shall promptly inform Cugene of any adversarial patent office proceeding or sua sponte filing, including a request for, or filing or declaration of, any interference, opposition, or reexamination relating to a Product Patent in the Territory. The Parties shall thereafter consult and cooperate to determine a course of action with respect to any such proceeding in the Territory and AbbVie shall consider in good faith all comments, requests, and suggestions provided by Cugene. If AbbVie decides not to prepare, file, prosecute, or maintain, or not to initiate or continue any Defense Proceeding relating to, a Product Patent in a country or other jurisdiction in the Territory, AbbVie shall provide reasonable prior written notice to Cugene of such intention (which notice shall, in any event, be given no later than 60 days prior to the next deadline for any action that may be taken with respect to such Product Patent in such country or other jurisdiction), and Cugene shall thereupon have the option, in its sole discretion, to assume the control and direction of the preparation, filing, prosecution, and maintenance of such Product Patent or the Defense Proceeding, as applicable, at Cugene's expense in such country or other jurisdiction, subject to the consent of AbbVie (which consent shall not be unreasonably withheld, conditioned or delayed). AbbVie's consent shall not be deemed unreasonably withheld, conditioned, or delayed if either (i) AbbVie decides not to file a continuing, divisional or child Product Patent application when the parent Patent application is pending or has been granted or (ii) AbbVie decides not to prepare, file, prosecute or maintain such Product Patent in a country in the Territory for bona fide reasons consistent with its patent portfolio strategy; provided that if AbbVie does not consent or fails to give consent to Cugene's assumption of the control and direction of the preparation, filing, prosecution and maintenance of such Product Patent or the Defense Proceeding in a country or jurisdiction and as a result Cugene's financial benefits under this Agreement would be adversely affected, AbbVie shall discuss such decision with Cugene in good faith and negotiate in good faith any changes to the financial terms under this Agreement, which may include the determination of Royalty Claims for Licensed Products in such country or jurisdiction.", "": "" }, { "Text": "(c) The Party with the first right to prosecute and maintain a Cugene Patent (or claims thereof), and to conduct any Defense Proceeding relating thereto, shall keep the other Party fully informed of all material steps with regard to the preparation, filing, prosecution, and maintenance of, and any Defense Proceeding relating to, the applicable Cugene Patents, including by providing the other Party with a copy of material filings and communications to and from any patent authority in the Territory regarding such Cugene Patents, and by providing the other Party drafts of any material filings or responses (including copies of the text of the applications) to be made to any patent authority in the United States, Japan, the European Union, China or Canada sufficiently in advance of submitting such filings or responses so as to allow for a reasonable opportunity for the other Party to review and comment thereon.", "": "" }, { "Text": "8.2.3. AbbVie Patents and Joint Patents. AbbVie shall have (a) the first right, but not the obligation, through the use of internal or outside counsel reasonably acceptable to Cugene, to prepare, file, prosecute, and maintain the Joint Patents, and to conduct any Defense Proceeding relating thereto (except that in connection with any actions subject to Section 8.3, the Party with responsibility for such action pursuant to Section 8.3 shall have responsibility for such Defense Proceedings), and (b) the sole right, but not the obligation, to prepare, file, prosecute, and maintain the AbbVie Patents and to conduct any Defense Proceeding relating thereto, in each case ((a) and (b)), worldwide, at AbbVie's sole cost and expense. AbbVie shall keep Cugene reasonably informed of all steps with regard to the preparation, filing, prosecution, and maintenance of, and any Defense Proceeding relating to, Joint Patents, including by providing Cugene with a copy of material filings and communications to and from any patent authority in the United States, Japan, the European Union, China or Canada regarding such Joint Patents, and by providing Cugene drafts of any material filings or responses to be made to any patent authority in the United States, Japan, the European Union, China or Canada sufficiently in advance of submitting such filings or responses so as to allow for a reasonable opportunity for Cugene to review and comment thereon. If AbbVie decides not to prepare, file, prosecute, or maintain, or not to initiate or continue any Defense Proceeding relating to, a Joint Patent in a country or other jurisdiction in the Territory, AbbVie shall provide reasonable prior written notice to Cugene of such intention (which notice shall, in any event, be given no later than 60 days prior to the next deadline for any action that may be taken with respect to such Joint Patent in such country or other jurisdiction), and Cugene shall thereupon have the option, in its sole discretion, to assume the control and direction of the preparation, filing, prosecution, and maintenance of such Joint Patent or the Defense Proceeding, as applicable, at Cugene's expense in such country or other jurisdiction, subject to the consent of AbbVie (which consent shall not be unreasonably withheld, conditioned or delayed). AbbVie's consent shall not be deemed unreasonably withheld, conditioned, or delayed if either (i) AbbVie decides not to file a continuing, divisional or child Joint Patent application when the parent Patent application is pending or has been granted or (ii) AbbVie decides not to prepare, file, prosecute or maintain such Joint Patent in a country in the Territory for bona fide reasons consistent with its patent portfolio strategy.", "": "" }, { "Text": "8.2.4. Cooperation. The Parties agree to cooperate fully in the preparation, filing, prosecution, and maintenance of, and any Defense Proceeding relating to, the Product Patents, Mixed Cugene Patents, Joint Patents and, at the request of AbbVie, the AbbVie Patents in the Territory under this Agreement. Cooperation shall include:", "": "" }, { "Text": "(a) executing all papers and instruments, or requiring its employees or contractors to execute such papers and instruments, so as to (i) effectuate the ownership of intellectual property set forth in Section 8.1.1 and Section 8.1.2; (ii) enable the other Party to apply for and to prosecute Patent applications in the Territory; and (iii) obtain and maintain any Patent extensions, supplementary protection certificates, and the like with respect to such Patents in the Territory, in each case ((i) through (iii)) to the extent provided for in this Agreement;", "": "" }, { "Text": "(b) consistent with this Agreement, assisting in any license registration processes with applicable governmental authorities that may be available in the Territory for the protection of a Party's interests in this Agreement; and", "": "" }, { "Text": "(c) promptly informing the other Party of any matters coming to such Party's attention that may materially affect the preparation, filing, prosecution, or maintenance of, or any Defense Proceeding relating to, any such Patents in the Territory.", "": "" }, { "Text": "8.2.5. Patent Term Extension and Supplementary Protection Certificate. After the License Option Effective Date, AbbVie shall be responsible for making decisions regarding patent term extensions, including supplementary protection certificates and any other extensions that are now or become available in the future, wherever applicable, for Product Patents, Mixed Cugene Patents, AbbVie Patents, and any Joint Patents in any country or other jurisdiction. AbbVie shall have the responsibility for applying for any extension or supplementary protection certificate with respect to such Patents in the Territory. AbbVie shall keep Cugene fully informed of its efforts to obtain such extension or supplementary protection certificate. Cugene shall, at AbbVie's cost, provide prompt and reasonable assistance, as requested by AbbVie, including by taking such action as patent holder as is required under any Applicable Law to obtain such patent extension or supplementary protection certificate. AbbVie shall pay all expenses in regard to obtaining the extension or supplementary protection certificate in the Territory.", "": "" }, { "Text": "8.2.6. CREATE Act. Notwithstanding anything to the contrary in this ARTICLE 8, neither Party shall have the right to make an election under the Cooperative Research and Technology Enhancement Act of 2004, 35 U.S.C. 103(c)(2)-(c)(3) (the \"CREATE Act\") when exercising its rights under this ARTICLE 8 without the prior written consent of the other Party. With respect to any such permitted election, the Parties shall coordinate their activities with respect to any submissions, filings, or other activities in support thereof. The Parties acknowledge and agree that this Agreement is a \"joint research agreement\" as defined in the CREATE Act.", "": "" }, { "Text": "8.2.7. Patent Listings. After the License Option Effective Date, AbbVie shall have the sole right to make all filings with Regulatory Authorities in the Territory with respect to Mixed Cugene Patents, Product Patents, AbbVie Patents, and Joint Patents, and to the extent required by Applicable Law, any other Other Cugene Patents, with respect to the Licensed Therapeutics and Licensed Products, including as required or allowed outside the United States, under the national implementations of Article 10.1(a)(iii) of Directive 2001/EC/83 or other international equivalents; provided that AbbVie shall consult with Cugene to determine the course of action with respect to such filings for Mixed Cugene Patents, Product Patents, Joint Patents and Other Cugene Patents. Cugene shall (a) provide to AbbVie all Information in Cugene's control that is necessary or reasonably useful to enable AbbVie to make such filings with Regulatory Authorities in the Territory with respect to such Patents, including a correct and complete list of Cugene Patents Covering any Licensed Product, and (b) cooperate with AbbVie's reasonable requests in connection therewith, including meeting any submission deadlines, in each case ((a) and (b)), to the extent required or permitted by Applicable Law.", "": "" }, { "Text": "8.2.8. UPC Opt-Out and Opt-In. AbbVie shall have the sole right to make any decision regarding whether or not to elect Opt-Out or Opt-In with respect to any Mixed Cugene Patent, Product Patent and Joint Patent; provided that AbbVie shall consider in good faith Cugene's comments with respect thereto.", "": "" }, { "Text": "8.2.9. Notice of Assignments. Cugene shall promptly notify AbbVie of any assignment (including to its Affiliates) of any Cugene Patent.", "": "" }, { "Text": "8.3. Enforcement of Patents.", "": "" }, { "Text": "8.3.1. Notice. Each Party shall promptly notify the other Party in writing of any alleged or threatened infringement of the Product Patents or Mixed Cugene Patents, in each case, by a Third Party in the Territory of which such Party becomes aware (including alleged or threatened infringement (x) of any Mixed Cugene Patent based on the development, commercialization, or an application to market a product containing a Licensed Therapeutic or any Licensed Product (including any Biosimilar Product) or a Competing Product in the Territory or (y) of any Product Patent (the \"Product Infringement\")).", "": "" }, { "Text": "8.3.2. Enforcement of Cugene Patents Prior to the License Option Effective Date. The following provisions shall apply with respect to enforcement of the Cugene Patents prior to the License Option Effective Date:", "": "" }, { "Text": "(a) Other Cugene Patents. Cugene shall have the sole right (except with respect to Mixed Cugene Patents, in which case Cugene shall have the first right), but not the obligation, to prosecute any Product Infringement with respect to Other Cugene Patents in the Territory, including as a defense or counterclaim in connection with any Third Party Infringement Claim, at its sole expense, and Cugene shall retain control of the prosecution of the applicable claim, suit, or proceeding with respect to such Product Infringement. If Cugene prosecutes any such Product Infringement, AbbVie shall have the right to join as a party to such claim, suit, or proceeding in the Territory and participate with its own counsel at its own expense to the extent such claim, suit, or proceeding relates to Mixed Cugene Patents; provided that Cugene shall retain control of the prosecution of such claim, suit, or proceeding. To the extent such claim, suit, or proceeding relates to Mixed Cugene Patents, Cugene shall: (a) provide AbbVie with drafts of all official papers and statements (whether written or oral) prior to their submission in such claim, suit, or proceeding, in sufficient time to allow AbbVie to review, consider and substantively comment thereon, (b) reasonably consider taking action to incorporate AbbVie's comments on all such official papers and statements, (c) allow AbbVie the opportunity to participate in the preparation of witnesses and other participants in such claim, suit, or proceeding, and (d) not settle any such claim, suit, or proceeding except in a manner that it believes in good faith is in the best interests of the Licensed Therapeutics or Licensed Products. If such Product Infringement relates to Mixed Cugene Patents and Cugene does not take commercially reasonable steps to prosecute such Product Infringement (i) within 90 days following the first notice provided above with respect to such Product Infringement, or (ii) provided such date occurs after the first such notice of such Product Infringement is provided, ten Business Days before the time limit, if any, set forth in appropriate laws and regulations for filing of such actions, whichever comes first, then AbbVie may prosecute such Product Infringement at its own expense.", "": "" }, { "Text": "(b) Product Patents. Cugene shall have the first right, but not the obligation, to prosecute any Product Infringement with respect to Product Patents in the Territory, including as a defense or counterclaim in connection with any Third Party Infringement Claim, at its sole expense, and Cugene shall retain control of the prosecution of the applicable claim, suit, or proceeding with respect to such Product Infringement. If Cugene prosecutes any such Product Infringement, AbbVie shall have the right to join as a party to such claim, suit, or proceeding in the Territory and participate with its own counsel at its own expense; provided that Cugene shall retain control of the prosecution of such claim, suit, or proceeding. Cugene shall: (a) provide AbbVie with drafts of all official papers and statements (whether written or oral) prior to their submission in such claim, suit, or proceeding, in sufficient time to allow AbbVie to review, consider and substantively comment thereon, (b) reasonably consider taking action to incorporate AbbVie's comments on all such official papers and statements, (c) allow AbbVie the opportunity to participate in the preparation of witnesses and other participants in such claim, suit, or proceeding, and (d) not settle any such claim, suit, or proceeding except in a manner that it believes in good faith is in the best interests of the Licensed Therapeutics or Licensed Products. If Cugene does not take commercially reasonable steps to prosecute such Product Infringement (i) within 90 days following the first notice provided above with respect to such Product Infringement, or (ii) provided such date occurs after the first such notice of such Product Infringement is provided, ten Business Days before the time limit, if any, set forth in appropriate laws and regulations for filing of such actions, whichever comes first, then AbbVie may prosecute such Product Infringement at its own expense.", "": "" }, { "Text": "8.3.3. Enforcement of Cugene Patents After the License Option Effective Date. The following provisions shall apply with respect to enforcement of the Cugene Patents on or after the License Option Effective Date:", "": "" }, { "Text": "(a) Other Cugene Patents. Cugene shall have the sole right (except with respect to Mixed Cugene Patents, in which case Cugene shall have the first right), but not the obligation, to prosecute any Product Infringement with respect to Other Cugene Patents in the Territory, including as a defense or counterclaim in connection with any Third Party Infringement Claim, at its sole expense, and Cugene shall retain control of the prosecution of the applicable claim, suit, or proceeding with respect to such Product Infringement. If Cugene prosecutes any such Product Infringement, AbbVie shall have the right to join as a party to such claim, suit, or proceeding in the Territory and participate with its own counsel at its own expense to the extent such claim, suit, or proceeding relates to Mixed Cugene Patents; provided that Cugene shall retain control of the prosecution of such claim, suit, or proceeding. To the extent such claim, suit, or proceeding relates to Mixed Cugene Patents, Cugene shall: (a) provide AbbVie with drafts of all official papers and statements (whether written or oral) prior to their submission in such claim, suit, or proceeding, in sufficient time to allow AbbVie to review, consider and substantively comment thereon, (b) reasonably consider taking action to incorporate AbbVie's comments on all such official papers and statements, (c) allow AbbVie the opportunity to participate in the preparation of witnesses and other participants in such claim, suit, or proceeding, and (d) not settle any such claim, suit, or proceeding except in a manner that it believes in good faith is in the best interests of the Licensed Therapeutics or Licensed Products. If such Product Infringement relates to Mixed Cugene Patents and Cugene does not take commercially reasonable steps to prosecute such Product Infringement (i) within 90 days following the first notice provided above with respect to such Product Infringement, or (ii) provided such date occurs after the first such notice of such Product Infringement is provided, ten Business Days before the time limit, if any, set forth in appropriate laws and regulations for filing of such actions, whichever comes first, then AbbVie may prosecute such Product Infringement at its own expense.", "": "" }, { "Text": "(b) Product Patents. AbbVie shall have the first right, but not the obligation, to prosecute any Product Infringement with respect to Product Patents in the Territory, including as a defense or counterclaim in connection with any Third Party Infringement Claim, at its sole expense (except as may be otherwise agreed to by the Parties in a cost-sharing arrangement), and AbbVie shall retain control of the prosecution of the applicable claim, suit, or proceeding with respect to such Product Infringement. If AbbVie prosecutes any such Product Infringement, Cugene shall have the right to join as a party to such claim, suit, or proceeding in the Territory and participate with its own counsel at its own expense; provided that AbbVie shall retain control of the prosecution of such claim, suit, or proceeding. AbbVie shall: (a) keep Cugene reasonably informed regarding material developments in such claim, suit, or proceeding and (b) not settle any such claim, suit, or proceeding except in a manner that it believes in good faith is in the best interests of the Licensed Therapeutics or Licensed Products. If AbbVie does not take commercially reasonable steps to prosecute a Product Infringement (i) within 90 days following the first notice provided above with respect to the Product Infringement, or (ii) provided such date occurs after the first such notice of the Product Infringement is provided, ten Business Days before the time limit, if any, set forth in appropriate laws and regulations for filing of such actions, whichever comes first, then Cugene may prosecute the Product Infringement at its own expense, unless AbbVie reasonably determines that refraining from prosecuting such alleged or threatened infringement would be more beneficial to the Licensed Products than enforcing it, in which case AbbVie shall have the sole right to determine whether or not to prosecute such infringement.", "": "" }, { "Text": "8.3.4. Enforcement of Joint Patents. Each Party shall promptly notify the other Party in writing of any alleged or threatened infringement of the Joint Patents by a Third Party in the Territory of which such Party becomes aware (including alleged or threatened infringement based on the development, commercialization, or an application to market a product containing a Licensed Therapeutic or any Licensed Product in the Territory). After the License Option Effective Date, AbbVie shall have the first right, but not the obligation, to prosecute any such infringement in the Territory, including as a defense or counterclaim in connection with any Third Party Infringement Claim, at its sole expense, and AbbVie shall retain control of the prosecution of the applicable claim, suit or proceeding with respect to such infringement. If AbbVie prosecutes any such infringement, Cugene shall have the right to join as a party to such claim, suit, or proceeding in the Territory and participate with its own counsel at its own expense; provided that AbbVie shall retain control of the prosecution of such claim, suit, or proceeding. AbbVie shall: (a) keep Cugene reasonably informed regarding material developments in such claim, suit, or proceeding and (b) not settle any such claim, suit, or proceeding except in a manner that it believes in good faith is in the best interests of the Licensed Therapeutics or Licensed Products. If AbbVie does not take commercially reasonable steps to prosecute the alleged or threatened infringement in the Territory with respect to such Joint Patents (a) within 90 days following the first notice provided above with respect to such alleged infringement, or (b) provided such date occurs after the first such notice of infringement is provided, ten Business Days before the time limit, if any, set forth in appropriate laws and regulations for filing of such actions, whichever comes first, then Cugene may prosecute the alleged or threatened infringement in the Territory at its own expense, unless AbbVie reasonably determines that refraining from prosecuting such alleged or threatened infringement would be more beneficial to the Licensed Products than enforcing it, in which case AbbVie shall have the sole right to determine whether or not to prosecute such infringement.", "": "" }, { "Text": "8.3.5. Enforcement of AbbVie Patents. Each Party shall promptly notify the other Party in writing of any alleged or threatened infringement of the AbbVie Patents by a Third Party in the Territory of which such Party becomes aware (including alleged or threatened infringement based on the development, commercialization, or an application to market a product containing a Licensed Therapeutic or any Licensed Product in the Territory). AbbVie shall have the sole right, but not the obligation, to prosecute any such infringement in the Territory, including as a defense or counterclaim in connection with any Third Party Infringement Claim, at its sole expense, and AbbVie shall retain control of the prosecution of the applicable claim, suit or proceeding with respect to such infringement and retain all recoveries in connection therewith.", "": "" }, { "Text": "8.3.6. Cooperation. The Parties agree to cooperate fully in any infringement action pursuant to this Section 8.3. If a Party brings such an action, the other Party shall, if necessary, furnish a power of attorney solely for such purpose or shall join in, or be named as a necessary party to, such action. Unless otherwise set forth herein, the Party entitled to bring any patent infringement litigation in accordance with this Section 8.3 shall have the right to settle such claim; provided that neither Party shall have the right to settle any patent infringement litigation under this Section 8.3 in a manner that imposes any costs or liability on, or involves any admission by, the other Party, without the express written consent of such other Party. The Party commencing the litigation shall provide the other Party with copies of all pleadings and other documents filed with the court and shall consider reasonable input from the other Party during the course of the proceedings.", "": "" }, { "Text": "8.3.7. Patent Exclusivity Listings. If either Party receives a copy of an application submitted to the FDA under subsection (k) of Section 351 of the PHSA (a \"Biosimilar Application\") naming a Licensed Product as a reference product or otherwise becomes aware that such a Biosimilar Application has been filed (such as in an instance described in Section 351(l)(9)(C) of the PHSA), such Party shall, within ten Business Days, notify the other Party so that the other Party may seek permission to view the application and related confidential information from the filer of the Biosimilar Application under Section 351(l)(1)(B)(iii) of the PHSA. If either Party receives any equivalent or similar certification or notice in any other jurisdiction in the Territory, such Party shall, within ten Business Days, notify and provide the other Party with copies of such communication. Regardless of the Party that is the \"reference product sponsor\" for purposes of such Biosimilar Application, after the License Option Effective Date (a) AbbVie shall have the sole right to designate pursuant to Section 351(l)(1)(B)(ii) of the PHSA the outside counsel and in-house counsel who shall receive confidential access to the Biosimilar Application; (b) AbbVie shall have the sole right to list any Patents, including Product Patents and Joint Patents, insofar as they Cover the applicable Licensed Product as required pursuant to Section 351(l)(3)(A), Section 351(l)(5)(b)(i)(II), or Section 351(l)(7) of the PHSA, to respond to any communications with respect to such lists from the filer of the Biosimilar Application, and to negotiate with the filer of the Biosimilar Application as to whether to utilize a different mechanism for information exchange than that specified in Section 351(l) of the PHSA; (c) AbbVie shall have the sole right to identify Patents or respond to communications under any equivalent or similar listing in any other jurisdiction in the Territory; and (d) Cugene shall cooperate in good faith with AbbVie with respect to any such certification or notice under Applicable Law, including with respect to proceedings related thereto. If required pursuant to Applicable Law, Cugene shall prepare such lists and make such responses at AbbVie's direction. Cugene shall (i) provide to AbbVie, within 15 days of AbbVie's request, all Information in Cugene's control that is necessary or reasonably useful to enable AbbVie to make such lists and communications with respect to the Product Patents, Mixed Cugene Patents, and to the extent required by Applicable Law, any other Other Cugene Patents, including a correct and complete list of Cugene Patents Covering any Licensed Product, and (ii) cooperate with AbbVie's reasonable requests in connection therewith, including meeting any submission deadlines, in each case, to the extent required or permitted by Applicable Law and at AbbVie's cost. AbbVie shall (A) reasonably consult with Cugene prior to identifying any Cugene Patents to a Third Party as contemplated by this Section 8.3.7 and shall consider in good faith Cugene's advice and suggestions with respect thereto, and (B) notify Cugene of any such lists or communications promptly after they are made.", "": "" }, { "Text": "8.3.8. Conduct of Patent Litigation Under the Biologics Price Competition and Innovation Act. Notwithstanding anything to the contrary in Section 8.3, AbbVie shall have the first right to bring an action for infringement of the AbbVie Patents and Joint Patents and, after the License Option Effective Date, Cugene Patents as required under Section 351(l)(6) of the PHSA following the agreement on a list of patents for litigation under Section 351(l)(4) or exchange of Patent lists pursuant to Section 351(l)(5)(B) of such act, or as required following any equivalent or similar certification or notice in any other jurisdiction. The Parties' rights and obligations with respect to the foregoing legal actions shall be as set forth in Section 8.3.2 through Section 8.3.5; provided that within 15 days of reaching agreement on a list of Patents for litigation under Section 351(l)(4) or exchange of Patent lists pursuant to Section 351(l)(5)(B), AbbVie shall notify Cugene as to whether or not it elects to prosecute such infringement. Either Party shall, within ten Business Days, notify and provide the other Party with copies of any notice of commercial marketing provided by the filer of a Biosimilar Application pursuant to Section 351(l)(8)(A) of the PHSA, or any equivalent or similar certification or notice in any other jurisdiction. Thereafter, the Party controlling any Patent infringement litigation pursuant to this Section 8.3.8 shall have the first right to seek an injunction against such commercial marketing as permitted pursuant to Section 351(l)(8)(B) of the PHSA. If no such litigation is ongoing at the time of such notice, then AbbVie shall have the first right to seek such an injunction.", "": "" }, { "Text": "8.3.9. Recovery. Except as otherwise agreed by the Parties in connection with a cost sharing arrangement and except with respect to costs incurred by a Party that joins and participates in such litigation at its sole cost and expense as set forth in this Section 8.3, any recovery realized as a result of such litigation described in Section 8.3.3 through Section 8.3.5 (whether by way of settlement or otherwise) shall be first allocated to reimburse the Parties for their costs and expenses in making such recovery (which amounts shall be allocated pro rata if insufficient to cover the totality of such expenses). Any remainder after such reimbursement is made shall be retained by the Party that has exercised its right to bring the enforcement action; provided that to the extent that any award or settlement (whether by judgment or otherwise) is attributable to loss of sales or profits with respect to a Licensed Product, the Parties shall negotiate in good faith an appropriate allocation of such remainder to reflect the economic interests of the Parties under this Agreement with respect to such Licensed Product. With respect to any litigation described in Section 8.3.2, Cugene shall be entitled to retain any recovery realized as a result thereof.", "": "" }, { "Text": "8.4. Infringement Claims by Third Parties.", "": "" }, { "Text": "8.4.1. If the manufacture, sale, or use of a Licensed Therapeutic or Licensed Product in the Territory pursuant to this Agreement results in, or may result in, any claim, suit, or proceeding by a Third Party alleging patent infringement by AbbVie (or its Affiliates or Sublicensees) (a \"Third Party Infringement Claim\"), including any defense or counterclaim in connection with an infringement action initiated pursuant to Section 8.3, the Party first becoming aware of such Third Party Infringement Claim shall promptly notify the other Party thereof in writing.", "": "" }, { "Text": "8.4.2. Notwithstanding Section 11.3.2, following the License Option Effective Date, AbbVie shall have the first right, but not the obligation, to defend and control the defense and settlement of any Third Party Infringement Claim at its own expense (but subject to deduction as provided below), using counsel of its own choice. Cugene may participate in any such Third Party Infringement Claim with counsel of its choice at its own expense. Without limitation of the foregoing, if AbbVie finds it necessary or desirable to join Cugene as a party to any such Third Party Infringement Claim, Cugene shall execute all papers and perform such acts as shall be reasonably required at AbbVie's expense.", "": "" }, { "Text": "8.4.3. AbbVie shall keep Cugene reasonably informed of all material developments in connection with any Third Party Infringement Claim. AbbVie shall have the right to settle any Third Party Infringement Claim in its reasonable discretion; provided that AbbVie shall not have the right to settle any Third Party Infringement Claim in a manner that imposes any costs or liability on, or involves any admission by, Cugene, without the express written consent of Cugene. If Cugene is named as a party in a Third Party Infringement Claim, (a) AbbVie agrees to provide Cugene with copies of all pleadings filed in the applicable action and to allow Cugene reasonable opportunity to participate in the defense of the Third Party Infringement Claim and (b) if AbbVie elects (in a written communication submitted to Cugene within a reasonable amount of time after notice of the alleged Third Party Infringement Claim) not to defend or control the defense and settlement of, or otherwise fails to initiate and maintain the defense of, such Third Party Infringement Claim, within such time periods so that Cugene is not prejudiced by any delays, subject to Section 8.6.3, Cugene may conduct and control the defense and settlement of such Third Party Infringement Claim at its own expense; provided that Cugene shall obtain the written consent of AbbVie prior to settling or compromising any such Third Party Infringement Claim.", "": "" }, { "Text": "8.4.4. AbbVie shall be entitled to deduct 50% of the out-of-pocket costs borne by AbbVie in defending or settling such Third Party Infringement Claim (including pursuant to any adverse judgment in connection therewith) from any royalties payable under Section 7.5.1 in accordance with and subject to the limitations set forth in Section 7.5.4 and Section 7.5.5(b). Any recoveries by a Party of any sanctions awarded to such Party and against a party asserting a claim being defended under this Section 8.4 shall be applied as follows: such recovery shall be applied first to (a) reimburse AbbVie for its out-of-pocket costs of defending such Third Party Infringement Claim to the extent not deducted from royalties pursuant to the previous sentence, and (b) reimburse Cugene for royalties deducted pursuant to the previous sentence. The balance of any such recoveries shall be retained by or provided to AbbVie and, to the extent that such recoveries are attributable to loss of sales or profits with respect to a Licensed Product, included in calculation of Net Sales for the relevant Licensed Product.", "": "" }, { "Text": "8.5. Invalidity or Unenforceability Defenses or Actions.", "": "" }, { "Text": "8.5.1. Notice. Each Party shall promptly notify the other Party in writing of any alleged or threatened assertion of invalidity or unenforceability of any of the Cugene Patents, AbbVie Patents, or Joint Patents by a Third Party, in each case in the Territory and of which such Party becomes aware.", "": "" }, { "Text": "8.5.2. Defense of Cugene Patents Prior to the License Option Effective Date. The following provisions shall apply with respect to defense of the Cugene Patents prior to the License Option Effective Date:", "": "" }, { "Text": "(a) Other Cugene Patents. Cugene shall have the sole right (except with respect to Mixed Cugene Patents, in which case Cugene shall have the first right), but not the obligation, to defend and control any claim, suit, or proceeding regarding the validity and enforceability of the Other Cugene Patents at its own expense in the Territory; provided that this Section 8.5.2(a) shall not apply to Defense Proceedings, which shall be governed by Section 8.2. AbbVie may participate in any claim, suit, or proceeding arising under this Section 8.5.2(a) in the Territory relating to Mixed Cugene Patents with counsel of its choice at its own expense; provided that Cugene shall retain control of the defense in such claim, suit, or proceeding. To the extent such claim, suit, or proceeding relates to Mixed Cugene Patents, Cugene shall: (i) provide AbbVie with drafts of all official papers and statements (whether written or oral) prior to their submission in such claim, suit, or proceeding, in sufficient time to allow AbbVie to review, consider and substantively comment thereon; (ii) reasonably consider taking action to incorporate AbbVie's comments on all such official papers and statements to the extent such claim, suit, or proceeding relates to such Mixed Cugene Patents; and (iii) allow AbbVie the opportunity to participate in the preparation of witnesses and other participants in such claim, suit, or proceeding to the extent such claim, suit, or proceeding relates to such Mixed Cugene Patents. If Cugene elects not to defend or control the defense of the Mixed Cugene Patents in a claim, suit, or proceeding arising under this Section 8.5.2(a) brought in the Territory, or otherwise fails to initiate and maintain the defense of any such claim, suit, or proceeding, and, in either case, has not settled and is not actively pursuing settlement of such claim, suit, or proceeding, then AbbVie may conduct and control the defense of any such claim, suit, or proceeding at its own expense (provided that Cugene shall have the right, at its own expense, to be represented in any such action by counsel of its own choice).", "": "" }, { "Text": "(b) Product Patents. Cugene shall have the first right, but not the obligation, to defend and control any claim, suit, or proceeding regarding the validity and enforceability of the Product Patents at its own expense in the Territory; provided that, this Section 8.5.2(b) shall not apply to Defense Proceedings, which shall be governed by Section 8.2. AbbVie may participate in any claim, suit, or proceeding arising under this Section 8.5.2(b) in the Territory with counsel of its choice at its own expense; provided that Cugene shall retain control of the defense in such claim, suit, or proceeding. Cugene shall: (i) provide AbbVie with drafts of all official papers and statements (whether written or oral) prior to their submission in such claim, suit, or proceeding, in sufficient time to allow AbbVie to review, consider and substantively comment thereon, (ii) reasonably consider taking action to incorporate AbbVie's comments on all such official papers and statements, (iii) allow AbbVie the opportunity to participate in the preparation of witnesses and other participants in such claim, suit, or proceeding, and (iv) not settle any such claim, suit, or proceeding except in a manner that it believes in good faith is in the best interests of the Licensed Therapeutics or Licensed Products. If Cugene elects not to defend or control the defense of the Product Patents in a claim, suit, or proceeding arising under this Section 8.5.2(b) brought in the Territory, or otherwise fails to initiate and maintain the defense of any such claim, suit, or proceeding, and, in either case, has not settled and is not actively pursuing settlement of such claim, suit, or proceeding, then AbbVie may conduct and control the defense of any such claim, suit, or proceeding at AbbVie's own expense (provided that Cugene shall have the right, at its own expense, to be represented in any such action by counsel of its own choice).", "": "" }, { "Text": "8.5.3. Defense of Cugene Patents After the License Option Effective Date. The following provisions shall apply with respect to defense of the Cugene Patents on or after the License Option Effective Date:", "": "" }, { "Text": "(a) Other Cugene Patents. Cugene shall have the sole right (except with respect to Mixed Cugene Patents, in which case Cugene shall have the first right), but not the obligation, to defend and control any claim, suit, or proceeding regarding the validity and enforceability of the Other Cugene Patents at its own expense in the Territory; provided that, this Section 8.5.3(a) shall not apply to Defense Proceedings, which shall be governed by Section 8.2. AbbVie may participate in any claim, suit, or proceeding arising under this Section 8.5.3(a) in the Territory relating to Mixed Cugene Patents with counsel of its choice at its own expense; provided that Cugene shall retain control of the defense in such claim, suit, or proceeding. To the extent such claim, suit, or proceeding relates to Mixed Cugene Patents, Cugene shall: (i) provide AbbVie with drafts of all official papers and statements (whether written or oral) prior to their submission in such claim, suit, or proceeding, in sufficient time to allow AbbVie to review, consider and substantively comment thereon, (ii) reasonably consider taking action to incorporate AbbVie's comments on all such official papers and statements, (iii) allow AbbVie the opportunity to participate in the preparation of witnesses and other participants in such claim, suit, or proceeding, and (iv) not settle any such claim, suit, or proceeding except in a manner that it believes in good faith is in the best interests of the Licensed Therapeutics or Licensed Products. If Cugene elects not to defend or control the defense of the Mixed Cugene Patents in a claim, suit, or proceeding arising under this Section 8.5.3(a) brought in the Territory, or otherwise fails to initiate and maintain the defense of any such claim, suit, or proceeding, and, in either case, has not settled and is not actively pursuing settlement of such claim, suit, or proceeding, then AbbVie may conduct and control the defense of any such claim, suit, or proceeding at its own expense (provided that Cugene shall have the right, at its own expense, to be represented in any such action by counsel of its own choice).", "": "" }, { "Text": "(b) Product Patents. AbbVie shall have the first right, but not the obligation, to defend and control any claim, suit, or proceeding regarding the validity and enforceability of the Product Patents at its own expense in the Territory; provided that, this Section 8.5.3(b) shall not apply to Defense Proceedings, which shall be governed by Section 8.2. Cugene may participate in any claim, suit, or proceeding arising under this Section 8.5.3(b) in the Territory with counsel of its choice at its own expense; provided that AbbVie shall retain control of the defense in such claim, suit, or proceeding. AbbVie shall: (i) keep Cugene reasonably informed regarding material developments in such claim, suit, or proceeding and (ii) not settle any such claim, suit, or proceeding except in a manner that it believes in good faith is in the best interests of the Licensed Therapeutics or Licensed Products. If AbbVie elects not to defend or control the defense of the Product Patents in a claim, suit, or proceeding arising under this Section 8.5.3(b) brought in the Territory, or otherwise fails to initiate and maintain the defense of any such claim, suit, or proceeding, and, in either case, has not settled and is not actively pursuing settlement of such claim, suit, or proceeding, then Cugene may conduct and control the defense of any such claim, suit, or proceeding at its own expense (provided that AbbVie shall have the right, at its own expense, to be represented in any such action by counsel of its own choice), unless AbbVie reasonably determines that refraining from initiating or maintaining the defense of such claim, suit, or proceeding would be more beneficial to the Licensed Products than enforcing it, in which case AbbVie shall have the sole right to control any such claim, suit, or proceeding.", "": "" }, { "Text": "8.5.4. Joint Patents. AbbVie shall have the first right, but not the obligation, to defend and control any claim, suit, or proceeding regarding the validity and enforceability of the Joint Patents at its own expense in the Territory; provided that this Section 8.5.4 shall not apply to Defense Proceedings, which shall be governed by Section 8.2. Cugene may participate in any claim, suit, or proceeding arising under this Section 8.5.4 in the Territory with counsel of its choice at its own expense; provided that AbbVie shall retain control of the defense in such claim, suit, or proceeding. AbbVie shall: (a) keep Cugene reasonably informed regarding material developments in such claim, suit, or proceeding and (b) not settle any such claim, suit, or proceeding except in a manner that it believes in good faith is in the best interests of the Licensed Therapeutics or Licensed Products. If AbbVie elects not to defend or control the defense of the Joint Patents in a claim, suit, or proceeding arising under this Section 8.5.4 brought in the Territory, or otherwise fails to initiate and maintain the defense of any such claim, suit, or proceeding, and, in either case, has not settled and is not actively pursuing settlement of such claim, suit, or proceeding, then Cugene may conduct and control the defense of any such claim, suit, or proceeding at its own expense (provided that AbbVie shall have the right, at its own expense, to be represented in any such action by counsel of its own choice), unless AbbVie reasonably determines that refraining from initiating or maintaining the defense of such claim, suit, or proceeding would be more beneficial to the Licensed Products than enforcing it, in which case AbbVie shall have the sole right to control any such claim, suit, or proceeding.", "": "" }, { "Text": "8.5.5. AbbVie Patents. AbbVie shall have the sole right, but not the obligation, to defend and control any claim, suit, or proceeding regarding the validity and enforceability of the AbbVie Patents at its own expense in the Territory.", "": "" }, { "Text": "8.5.6. Cooperation. Each Party shall assist and cooperate with the other Party as such other Party may reasonably request from time to time in connection with its activities set forth in this Section 8.5, including by being joined as a party plaintiff in the applicable claim, suit or proceeding described in Section 8.5.2 through Section 8.5.5, providing access to relevant documents and other evidence, and making its employees available at reasonable business hours. In connection with any such claim, suit or proceeding, the controlling Party shall consider in good faith any comments from the other Party and shall keep the other Party reasonably informed of any steps taken, and shall provide copies of all documents filed, in connection with such claim, suit or proceeding. In connection with the activities set forth in this Section 8.5, each Party shall consult with the other as to the strategy for the defense of the Cugene Patents and Joint Patents. Unless otherwise set forth herein, the Party entitled to control such claim, suit, or proceeding in accordance with this Section 8.5 shall have the right to settle such claim, suit, or proceeding; provided that neither Party shall have the right to settle any claim, suit, or proceeding under this Section 8.5 in a manner that imposes any costs or liability on, or involves any admission by, the other Party, without the express written consent of such other Party. For clarity, AbbVie shall no longer be required to assist Cugene and Cugene shall no longer be obligated to consult with AbbVie, in each case as contemplated by this Section 8.5.6, if the License Option expires without exercise by AbbVie, from and after the expiration of the License Option Period with respect to any Cugene Patents.", "": "" }, { "Text": "8.6. Third Party Licenses and Patents.", "": "" }, { "Text": "8.6.1. Cugene. If, prior to the License Option Effective Date, Cugene or any of its Affiliates enters into a license agreement with a Third Party, pursuant to which Cugene or its Affiliate in-licenses any Patent or Information that is necessary or reasonably useful to Exploit a Licensed Therapeutic or Licensed Product in the Field in the Territory, then such Patent or Information shall automatically be deemed to be Controlled by Cugene and Cugene shall be solely responsible for any payments arising under such license agreement as a result of the license grants to AbbVie pursuant to Section 4.1. If, after the License Option Effective Date, Cugene becomes aware of any Third Party's Patent or Information that is necessary or reasonably useful to Exploit a Licensed Therapeutic or Licensed Product in the Field in the Territory, Cugene shall notify AbbVie. AbbVie shall lead and have the sole right, but not the obligation, to negotiate with such Third Party for obtaining a license under such Third Party's Patent or Information to Exploit the Licensed Therapeutics or Licensed Products in the Field in the Territory and Cugene shall not, and shall cause its Affiliates not to, enter into any license under such Third Party's Patent or Information for the Exploitation of the Licensed Therapeutics or Licensed Products in the Field in the Territory after the License Option Effective Date. If Cugene breaches such obligation, then the applicable Patents or Information that are the subject of such license shall automatically be deemed Controlled by Cugene and Cugene shall be solely responsible for any payments arising under such license agreement as a result of the license grants to AbbVie pursuant to Section 4.1. For clarity, Cugene or its Affiliates or collaborators shall have the right, but not the obligation, to negotiate with any party, including such Third Party, for obtaining a license to Exploit Excluded Compounds and products thereof in any field and any territory as long as such license does not include the right to practice or utilize any Third Party's Patent or Information for the Exploitation of any Licensed Therapeutic or Licensed Product in the Field in the Territory.", "": "" }, { "Text": "8.6.2. AbbVie. If on or after the License Option Effective Date, AbbVie determines that any Patent, trade secret, or other intellectual property right of a Third Party in any country or other jurisdiction in the Territory is necessary or reasonably useful for the Development, Manufacture, or Commercialization of any Licensed Therapeutic or Licensed Product by AbbVie, any of its Affiliates, or any of its or their Sublicensees, then AbbVie shall have the right, but not the obligation, to negotiate and obtain a license or other right from such Third Party for AbbVie and its Affiliates and its and their Sublicensees to Develop, Manufacture, or Commercialize Licensed Therapeutics and Licensed Products in such country or other jurisdiction, including in connection with settlement of a Third Party infringement claim pursuant to Section 8.4.", "": "" }, { "Text": "8.6.3. Third Party Patent Challenges. If in the reasonable opinion of AbbVie, a Third Party's Patent may relate to the Exploitation of any Licensed Therapeutic (if such Licensed Therapeutic is not used in any product that is Developed or Commercialized by Cugene outside the scope of this Agreement) or Licensed Product under this Agreement, on and after the License Option Effective Date, AbbVie shall have the sole right, but not the obligation, to challenge the patentability, validity, or enforceability of such Patent in any court of competent jurisdiction or before any supra-national, federal, national, regional, state, provincial, or local governmental body of competent jurisdiction, including the United States Patent and Trademark Office and the European Patent Office. On and after the License Option Effective Date, Cugene shall not challenge the patentability, validity, or enforceability of such Patent in any court or governmental body without AbbVie's prior written consent (not to be unreasonably withheld, conditioned, or delayed). Cugene shall assist and cooperate with AbbVie as AbbVie may reasonably request from time to time in connection with the activities set forth in this Section 8.6.3.", "": "" }, { "Text": "8.7. Product Trademarks.", "": "" }, { "Text": "8.7.1. Ownership and Prosecution of Product Trademarks. AbbVie shall own all right, title, and interest to the Product Trademarks in the Territory, and shall be responsible for the registration, prosecution, and maintenance thereof. All costs and expenses of registering, prosecuting, and maintaining the Product Trademarks shall be borne solely by AbbVie. Cugene shall, at AbbVie's cost, provide all assistance and documents reasonably requested by AbbVie in support of its prosecution, registration, and maintenance of the Product Trademarks.", "": "" }, { "Text": "8.7.2. Enforcement of Product Trademarks. AbbVie shall have the sole right and responsibility for taking such action as AbbVie deems necessary against a Third Party based on any alleged, threatened, or actual infringement, dilution, misappropriation, or other violation of, or unfair trade practices or any other like offense relating to, the Product Trademarks by a Third Party in the Territory. AbbVie shall bear the costs and expenses relating to any enforcement action commenced pursuant to this Section 8.7.2 and any settlements and judgments with respect thereto, and shall retain any damages or other amounts collected in connection therewith.", "": "" }, { "Text": "8.7.3. Third Party Claims. AbbVie shall have the sole right and responsibility for defending against and settling any alleged, threatened, or actual claim by a Third Party that the use or registration of the Product Trademarks in the Territory infringes, dilutes, misappropriates, or otherwise violates any Trademark or other right of that Third Party or constitutes unfair trade practices or any other like offense, or any other claims as may be brought by a Third Party against a Party in connection with the use of the Product Trademarks with respect to a Licensed Product in the Territory. AbbVie shall bear the costs and expenses relating to any defense commenced pursuant to this Section 8.7.3 and any settlements and judgments with respect thereto, and shall retain any damages or other amounts collected in connection therewith.", "": "" }, { "Text": "8.7.4. Notice and Cooperation. Each Party shall provide to the other Party prompt written notice of any actual or threatened infringement of the Product Trademarks in the Territory and of any actual or threatened claim that the use of the Product Trademarks in the Territory violates the rights of any Third Party. Each Party agrees to cooperate fully with the other Party with respect to any enforcement action or defense commenced pursuant to this Section 8.7.", "": "" }, { "Text": "8.8. Inventor's Remuneration. Each Party shall be solely responsible for any remuneration that may be due such Party's employees or agents that are inventors under any applicable inventor remuneration laws.", "": "" }, { "Text": "8.9. Common Interest. All Information exchanged between the Parties regarding the prosecution, maintenance, enforcement and defense of Patents under this ARTICLE 8 will be deemed to be Confidential Information of each Party that Controls the applicable Patent. In addition, each Party acknowledges and agrees that, with regard to such prosecution, maintenance, enforcement and defense, the interests of the Parties as collaborators, licensors or licensees are to, for their mutual benefit, obtain patent protection and plan patent defense against potential patentability/invalidity challenges or infringement activities by Third Parties, and as such, are aligned and are legal in nature. Each Party agrees and acknowledges that it has not waived, and nothing in this Agreement constitutes a waiver of, any legal privilege concerning Patents under this ARTICLE 8, including privilege under the common interest doctrine and similar or related doctrines. Notwithstanding anything to the contrary in this Agreement, to the extent a Party has a good faith belief that any Information required to be disclosed by such Party to the other Party under this ARTICLE 8 is protected by attorney-client privilege or any other applicable legal privilege or immunity, such Party shall not be required to disclose such Information unless and until the Parties have agreed upon a procedure (which may include entering into a specific common interest agreement, disclosing such Information on a \"for counsel eyes only\" basis or similar procedure) under which such Information may be disclosed without waiving or breaching such privilege or immunity. The Parties shall in good faith cooperate to agree upon any such procedures.", "": "" }, { "Text": "ARTICLE 9 CONFIDENTIALITY AND NON-DISCLOSURE", "": "" }, { "Text": "9.1. Confidentiality Obligations.", "": "" }, { "Text": "9.1.1. At all times during the Term and for a period of ten years following termination or expiration of this Agreement in its entirety, each Party shall and shall cause its officers, directors, employees, agents and contractors to, keep confidential and not publish or otherwise disclose to a Third Party and not use, directly or indirectly, for any purpose, any Confidential Information furnished or otherwise made known to it, directly or indirectly, by the other Party, except to the extent such disclosure or use is expressly permitted by the terms of this Agreement. \"Confidential Information\" means any technical, business or other Information provided or made available by or on behalf of one Party or any of its Affiliates (the \"Disclosing Party\") to the other Party or any of its Affiliates (the \"Receiving Party\") in connection with this Agreement, whether prior to, on or after the Effective Date, including the terms of this Agreement (subject to Section 9.3), Information relating to any Development or Commercialization of any Licensed Therapeutic or Licensed Product, any Information with respect thereto developed by or on behalf of the Disclosing Party or its Affiliates or, in the case of AbbVie, its Affiliates or its or their Sublicensees or the scientific, regulatory or business affairs or other activities of either Party or its Affiliates. Notwithstanding the foregoing, irrespective of the Party who first disclosed it, (a) any Information Controlled by Cugene or any of its Affiliates (including Cugene Know-How and Joint Know-How) that specifically relates to any Licensed Therapeutic or Licensed Product or the Exploitation thereof, including the Regulatory Documentation applicable to the Licensed Therapeutics or Licensed Products (\"Product Information\") shall (i) during the Term prior to the License Option Effective Date, be deemed the Confidential Information of both Parties (and both Parties shall be deemed to be the Disclosing Party, and both Parties shall be deemed to be the Receiving Party, with respect thereto), (ii) after the License Option Effective Date and before the termination of this Agreement, be deemed the Confidential Information of AbbVie (and AbbVie shall be deemed to be the Disclosing Party, and Cugene shall be deemed to be the Receiving Party, with respect thereto), and (iii) upon termination of this Agreement, be deemed the Confidential Information of Cugene (and Cugene shall be deemed to be the Disclosing Party and AbbVie shall be deemed to be the Receiving Party with respect thereto); and (b) the terms of this Agreement shall be deemed to be the Confidential Information of both Parties (and both Parties shall be deemed to be the Receiving Party and the Disclosing Party with respect thereto).", "": "" }, { "Text": "9.1.2. Notwithstanding Section 9.1.1, the confidentiality and non-use obligations under this Section 9.1 with respect to any Confidential Information shall not apply to any information that:", "": "" }, { "Text": "(a) has been published by a Third Party or otherwise is or hereafter becomes part of the public domain by public use, publication, general knowledge or the like through no wrongful act, fault, or negligence by the Receiving Party;", "": "" }, { "Text": "(b) can be demonstrated by documentation or other competent proof to have been in the Receiving Party's possession prior to disclosure by the Disclosing Party without any obligation of confidentiality with respect to such information; provided that the foregoing exception shall not apply with respect to Product Information;", "": "" }, { "Text": "(c) is subsequently received by the Receiving Party from a Third Party who is not bound by any obligation of confidentiality with respect to such information;", "": "" }, { "Text": "(d) has been published by a Third Party or otherwise enters the public domain through no fault of the Receiving Party in breach of this Agreement; or", "": "" }, { "Text": "(e) can be demonstrated by documentation or other competent evidence to have been independently developed by or for the Receiving Party without reference to the Disclosing Party's Confidential Information; provided that the foregoing exception shall not apply with respect to Product Information.", "": "" }, { "Text": "Specific aspects or details of Confidential Information shall not be deemed to be within the public domain or in the possession of the Receiving Party merely because the Confidential Information is embraced by more general information in the public domain or in the possession of the Receiving Party. Further, any combination of Confidential Information shall not be considered in the public domain or in the possession of the Receiving Party merely because individual elements of such Confidential Information are in the public domain or in the possession of the Receiving Party unless the combination and its principles are in the public domain or in the possession of the Receiving Party.", "": "" }, { "Text": "9.2. Permitted Disclosures. The Receiving Party may use and disclose Confidential Information of the Disclosing Party to the extent that such disclosure is:", "": "" }, { "Text": "9.2.1. made in response to a valid order of an arbitral tribunal, court of competent jurisdiction or other Governmental Authority of competent jurisdiction or, if in the reasonable opinion of the Receiving Party's legal counsel, such disclosure is otherwise required by Applicable Law or the rules of a stock exchange on which the securities of the Receiving Party (or any controlling Affiliate of such Party) are listed (or to which an application for listing has been submitted); provided, however, that if the Receiving Party is required to make any such disclosure of the Disclosing Party's Confidential Information, the Receiving Party shall, to the extent legally permissible, promptly notify the Disclosing Party in advance (and to the extent possible, with at least five Business Days' notice) and give the Disclosing Party a reasonable opportunity to quash such order or to obtain a protective order or confidential treatment requiring that the Confidential Information and documents that are the subject of such order or required to be disclosed be held in confidence by such court or Governmental Authority or, if disclosed, be used only for the purposes for which the order was issued or such disclosure was required by Applicable Law or such rules; provided, further, that the Confidential Information disclosed in response to such court or governmental order or as required by Applicable Law or the rules of a stock exchange on which the securities of the Receiving Party (or any controlling Affiliate of such Party) are listed (or to which an application for listing has been submitted) shall be limited to the information that is legally required to be disclosed in response to such court or governmental order or by such Applicable Law or such rules; or", "": "" }, { "Text": "9.2.2. made by or on behalf of the Receiving Party to a patent authority as may be reasonably necessary or useful for purposes of obtaining or enforcing a Patent under this Agreement; provided, however, that reasonable measures shall be taken to assure confidential treatment of such information, to the extent such protection is available.", "": "" }, { "Text": "9.3. Additional Permitted Disclosures and Use by AbbVie. After the License Option Effective Date, AbbVie and its Affiliates and its and their Sublicensees may disclose and use Confidential Information of Cugene as may be necessary or reasonably useful in connection with the Exploitation of the Licensed Therapeutic and Licensed Products under the terms of this Agreement, including in connection with any filing, application or request for Regulatory Approval by or on behalf of AbbVie or any of its Affiliates or any of its or their Sublicensees for any Licensed Product and including to existing or potential Distributors, Sublicensees, collaboration partners or acquirers or transferees; provided that (a) subject to the following clause (b) such Persons will be subject to obligations of confidentiality and non-use with respect to such Confidential Information no less stringent than the obligations of confidentiality and non-use of AbbVie pursuant to this ARTICLE 9 (with a duration of confidentiality and non-use obligations as appropriate that is no less than five years from the date of disclosure) and (b) with respect to any such disclosure to any Regulatory Authority in connection with any filing, application or request for Regulatory Approval by or on behalf of AbbVie or any of its Affiliates, AbbVie shall take reasonable measures to assure confidential treatment of such information, to the extent such protection is available.", "": "" }, { "Text": "9.4. Additional Permitted Disclosures and Use by Cugene. Cugene and its Affiliates may disclose and use Confidential Information of AbbVie as may be necessary or reasonably useful for Cugene to exercise its rights or fulfill its obligations under this Agreement, including in connection with any filing or submission to Regulatory Authorities by or on behalf of Cugene or any of its Affiliates for any Licensed Therapeutic or Licensed Product; provided that (a) any Persons receiving such Confidential Information will be subject to the obligations of confidentiality and non-use with respect to such Confidential Information substantially similar to the obligations of confidentiality and non-use of Cugene pursuant to this ARTICLE 9 (with a duration of confidentiality and non-use obligations as appropriate that is no less than five years from the date of disclosure), and (b) with respect to any such disclosure to any Regulatory Authority in connection with any filing or submission by or on behalf of Cugene or any of its Affiliates, Cugene shall take reasonable measures to assure confidential treatment of such information, to the extent such protection is available. In addition, Cugene and its Affiliates may disclose AbbVie's Confidential Information (including the terms of this Agreement) on a need-to-know basis to Cugene's or its Affiliates' (i) attorneys, independent accountants, financial advisors, underwriters, acquisition partners, financing sources or investors or (ii) actual or potential licensing partners or collaborators with respect to IL-2 Muteins (or muteins, antibodies, compounds, molecules or other therapeutics comprising an IL-2 Mutein) that are not Licensed Therapeutics; provided that, in each case ((i) and (ii)), (A) such Cugene and such actual or potential licensing partner, collaborator, acquisition partner, financing source, or investor must be engaged in bona fide negotiations, (B) Cugene must be expecting to close such acquisition, financing, or investment, as applicable, within 45 days, (C) with respect to an actual or potential licensing partner", "": "" }, { "Text": "CONFIDENTIAL EXECUTION VERSION", "": "" }, { "Text": "AMENDMENT NO. 1 TO RESEARCH COLLABORATION AND OPTION AGREEMENT", "": "" }, { "Text": "This Amendment No. 1 to the Research Collaboration and Option Agreement (this \"Amendment\") is effective as of April 1, 2022 (the \"First Amendment Effective Date\") and is entered into by and between DRAGONFLY THERAPEUTICS, INC., a corporation organized and existing under the laws of Delaware (\"Company\"), and ABBVIE IRELAND NL BV, a private limited liability company organized and existing under the laws of the Netherlands (\"AbbVie\").", "": "" }, { "Text": "RECITALS:", "": "" }, { "Text": "WHEREAS, Company and AbbVie entered into that certain Research Collaboration and Option Agreement, dated November 19, 2019 (the \"Agreement\");", "": "" }, { "Text": "WHEREAS, AbbVie is interested in adding Additional Collaboration Targets (as defined below) under the Agreement; and", "": "" }, { "Text": "WHEREAS, in connection with the addition of such Additional Collaboration Targets, Company and AbbVie wish to amend and update certain portions of the Agreement as set forth herein.", "": "" }, { "Text": "NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants contained herein, the receipt and sufficiency of which are hereby acknowledged, Company and AbbVie hereby agree as follows:", "": "" }, { "Text": "ARTICLE 1 AMENDMENT PAYMENT.", "": "" }, { "Text": "1.1 Additional Collaboration Target Payment. In consideration for Company's performance of its obligations under the Collaboration Programs with respect to the Additional Collaboration Targets, upon the terms and conditions contained herein and the Agreement, AbbVie shall pay Company a one-time, non-refundable, non-creditable payment equal to Forty Eight Million U.S. Dollars ($48,000,000), payable within thirty (30) days after the First Amendment Effective Date.", "": "" }, { "Text": "ARTICLE 2 DESIGNATION OF ADDITIONAL COLLABORATION TARGETS.", "": "" }, { "Text": "2.1 The Parties hereby agree the Additional Collaboration Targets are considered Collaboration Targets under the Agreement, effective as of the First Amendment Effective Date.", "": "" }, { "Text": "ARTICLE 3 OTHER AMENDMENTS.", "": "" }, { "Text": "3.1 Addition of \"Additional Collaboration Targets\". The below definition of \"Additional Collaboration Targets\" is hereby added after Section 1.16:", "": "" }, { "Text": "\"Additional Collaboration Targets\" means CD248 and OX40.", "": "" }, { "Text": "3.2 Addition of \"Applicable Date\". The below definition of \"Applicable Date\" is hereby added after Section 1.22:", "": "" }, { "Text": "\"Applicable Date\" has the meaning set forth in Section 6.2.", "": "" }, { "Text": "3.3 Amendment to Section 1.34. Section 1.34 of the Agreement is hereby deleted in its entirety and replaced with the following:", "": "" }, { "Text": "1.34 \"Collaboration Target\" means each (a) Initial Collaboration Target, (b) Substitute Collaboration Target, (c) Renewed Collaboration Target, or (d) as of the First Amendment Effective Date, Additional Collaboration Target.", "": "" }, { "Text": "3.4 Amendment to Section 1.42. The below sentence is hereby added after the last sentence of Section 1.42:", "": "" }, { "Text": "Schedule 6.2.1 shall be updated in accordance with Section 6.2 in order to reflect any Company Background Patents existing as of the First Amendment Effective Date that are Company Background Patents due to the addition of the Additional Collaboration Targets as Collaboration Targets as of the First Amendment Effective Date.", "": "" }, { "Text": "3.5 Amendment to Section 1.72. The below sentence is hereby added after the last sentence of Section 1.72:", "": "" }, { "Text": "Schedule 6.3 shall be updated in accordance with Section 6.3 in order to reflect any Existing License Agreements existing as of the First Amendment Effective Date that are Existing License Agreements due to the addition of the Additional Collaboration Targets as Collaboration Targets as of the First Amendment Effective Date.", "": "" }, { "Text": "3.6 Addition of \"First Amendment Effective Date\". The below definition of \"First Amendment Effective Date\" is hereby added after Section 1.76:", "": "" }, { "Text": "\"First Amendment Effective Date\" shall have the meaning set forth in that certain Amendment No. 1 to the Research Collaboration and Option Agreement between the Parties, dated April 1, 2022.", "": "" }, { "Text": "3.7 Addition of \"Original Collaboration Programs\". The below definition of \"Original Collaboration Programs\" is hereby added after Section 1.105:", "": "" }, { "Text": "\"Original Collaboration Programs\" means any Collaboration Program other than those Collaboration Programs with respect to an Additional Collaboration Target.", "": "" }, { "Text": "3.8 Amendment to Section 2.1.2. Each instance where \"Initial Collaboration Target\" is used throughout Section 2.1.2(a) – (d), \"Initial Collaboration Target\" is hereby deleted and replaced with \"Initial Collaboration Target or Additional Collaboration Target, as applicable\".", "": "" }, { "Text": "3.9 Amendment to Section 2.7. Section 2.7 of the Agreement is hereby deleted in its entirety and replaced with the following:", "": "" }, { "Text": "2.7 Collaboration Program Term. On a Collaboration Program-by-Collaboration Program basis, unless this Agreement is terminated earlier pursuant to Section 8.2 or 8.3, the term of each Collaboration Program shall commence (a) with respect to an Initial Collaboration Target, on the Effective Date, (b) with respect to an Additional Collaboration Target, on the First Amendment Effective Date, and (c) with respect to any Substitution Collaboration Target or Renewed Collaboration Target, the date on which such Target becomes a Collaboration Target, and shall continue until the date that is the earlier of (x) the date of Opt-In Exercise for such Collaboration Target and (y) expiration of the Opt-In Term for such Collaboration Target without AbbVie exercising its Opt-In Right with respect to such Collaboration Target (each, a \"Collaboration Program Term\").", "": "" }, { "Text": "3.10 Amendments to Section 5.1. Section 5.1 of the Agreement is hereby deleted in its entirety and replaced with the following:", "": "" }, { "Text": "5.1 Payments for the Original Collaboration Programs. In consideration for Company's performance of its obligations under the Original Collaboration Programs, upon the terms and conditions contained herein, AbbVie shall pay Company a one-time, non-refundable, non-creditable payment equal to thirty three million dollars ($33,000,000.00), payable within thirty (30) days after the Effective Date.", "": "" }, { "Text": "3.11 Amendments to Section 5.2.1. Section 5.2.1 of the Agreement is hereby deleted in its entirety and replaced with the following:", "": "" }, { "Text": "In consideration for the licenses and other rights granted to AbbVie herein following Opt-In Exercise and upon the terms and conditions contained herein, AbbVie shall pay to Company an amount equal to (a) twenty five million dollars ($25,000,000.00) for each Opt-In Exercise by AbbVie with respect to any Collaboration Target other than an Additional Collaboration Target, and (b) thirty five million dollars ($35,000,000) for each Opt-In Exercise by AbbVie with respect to any Additional Collaboration Target, in each case (a) and (b), as indicated in its the written notice(s) delivered by AbbVie pursuant to Section 3.1. Each such payment shall be due within thirty (30) days of the applicable written notice.", "": "" }, { "Text": "3.12 Amendment to Section 6.2. The first sentence in Section 6.2 is hereby deleted in its entirety and replaced with the following: \"Company represents and warrants to AbbVie that (i) as of the Effective Date and (ii) solely with respect to each of the Additional Collaboration Targets, as of the First Amendment Effective Date, (such date, (i) or (ii), the \"Applicable Date\"), and covenants as follows:", "": "" }, { "Text": "3.13 Amendment to Section 6.2.1 – Section 6.2.20. Each instance where \"Effective Date\" is used throughout Sections 6.2.1 – 6.2.20, \"Effective Date\" is hereby deleted and replaced with \"Applicable Date\".", "": "" }, { "Text": "3.14 Amendment to Section 6.2.4. Section 6.2.4 of the Agreement is hereby deleted in its entirety and replaced with the following:", "": "" }, { "Text": "It owns the entire right, title and interest in, or otherwise has the rights under the Existing License Agreements to, the Company Background IP existing as of the Applicable Date which, in the reasonable and good faith judgment of the Company is directly related to the Initial Collaboration Targets or Additional Collaboration Targets, as applicable, or likely to be necessary or reasonably useful for the Development, Manufacture, Commercialization or other Exploitation of a Collaboration Compound, Licensed Compound or Licensed Product (the \"Existing Company Background IP\"), free of any encumbrance, lien or claim of ownership by any Third Party (except by a licensor under any Existing License Agreements) and sufficient to perform its obligations under this Agreement, including to grant the licenses, rights, and interests granted to AbbVie under this Agreement.", "": "" }, { "Text": "3.15 Amendment to Section 6.2.8. The last sentence of Section 6.2.8 is hereby deleted in its entirety and replaced with the following: \"As of the Applicable Date, none of Company, its Affiliates or any Third Party is in breach of any Existing License Agreement.", "": "" }, { "Text": "3.16 Amendments to Section 6.2.10. The second sentence of Section 6.2.10 is hereby deleted in its entirety and replaced with the following: \"To the best of Company's knowledge, there is no Know-How owned or Controlled by Company or any of its Affiliates as of the Applicable Date that relates to the Collaboration Targets or Collaboration Compounds that is not within the Company Background Know-How existing as of the Applicable Date which, in the reasonable and good faith judgment of the Company is directly related to the Initial Collaboration Targets or Additional Collaboration Targets, as applicable, or likely to be necessary or reasonably useful for the Development, Manufacture, Commercialization or other Exploitation of a Collaboration Compound, Licensed Compound or Licensed Product (the \"Existing Company Background Know-How\").", "": "" }, { "Text": "3.17 Amendment to Section 6.3. The first sentence of Section 6.3 is hereby deleted in its entirety and replaced with the following: \"Company represents and warrants to AbbVie that it has provided to AbbVie as of the Applicable Date a true, correct and complete copy of each Existing License Agreement, and each such copy includes any and all amendments, restatements, side letters, and other modifications thereto, as each such Existing License Agreement is in effect as of the Applicable Date.", "": "" }, { "Text": "3.18 Amendment of Certain Cross-References. Any cross-references required to be updated as a result of the changes set forth herein are hereby deemed as updated.", "": "" }, { "Text": "ARTICLE 4 RESEARCH PLANS.", "": "" }, { "Text": "4.1 The Committee shall be responsible for creating a new Research Plan for each Additional Collaboration Target within sixty (60) days of the First Amendment Effective Date, which new Research Plans will be of similar scope to the Research Plan for the DC-SIGN Collaboration Program. Upon agreement by the Committee, the Research Plans for the Additional Collaboration Targets will be Schedule 2.1.1-3 and Schedule 2.1.1-4 under the Agreement. In the event the Committee does not reach agreement on a new Research Plan for either of the Additional Collaboration Targets, resolution will proceed as set forth in Section 2.3.1(b) of the Agreement; provided, that (i) notwithstanding Section 2.3.1(b), Company shall not have final decision-making authority with respect to such Research Plans for any Additional Collaboration Target, which shall require mutual written agreement by an authorized representative of each Party, and (ii) Company may not withhold agreement to a Research Plan for any Additional Collaboration Target if it is materially similar to the Research Plan for the DC-SIGN Collaboration Program.", "": "" }, { "Text": "ARTICLE 5 MISCELLANEOUS.", "": "" }, { "Text": "5.1 Definitions. Capitalized terms used herein but not otherwise defined shall have the meanings ascribed to such terms in the Agreement.", "": "" }, { "Text": "5.2 Reference to Agreement. Upon and after the effectiveness of this Amendment, each reference in the Agreement to \"this Agreement\", \"hereunder\", \"hereof\" or words of like import referring to the Agreement shall mean and be a reference to the Agreement as modified and amended hereby.", "": "" }, { "Text": "5.3 Effectiveness of Amendment. Upon execution and delivery of this Amendment by both Parties, the amendments set forth above shall be effective as of the First Amendment Effective Date. Except as specifically amended above, the Agreement is and shall continue to be in full force and effect and is hereby in all respects ratified and confirmed and shall constitute the legal, valid, binding and enforceable obligations of the Parties.", "": "" }, { "Text": "5.4 Applicable Law. This Amendment shall be governed by and construed in accordance with the laws of the State of New York without reference to any rules of conflict of laws or renvoi.", "": "" }, { "Text": "5.5 Dispute Resolution. The Parties shall resolve any dispute arising from or related to this Amendment as set forth in Section 10.7 of the Agreement.", "": "" }, { "Text": "5.6 Headings. The captions to the several Articles, Sections and subsections hereof are not a part of this Amendment, but are merely for convenience to assist in locating and reading the several Articles and Sections hereof.", "": "" }, { "Text": "5.7 Counterparts. This Amendment may be signed in any number of counterparts (including by facsimile or electronic transmission), each of which shall be deemed an original, but all of which shall constitute one and the same instrument. After facsimile or electronic transmission, the Parties agree to execute and exchange documents with original signatures.", "": "" }, { "Text": "[Signature page follows]", "": "" }, { "Text": "SCHEDULE 6.2.1", "": "" }, { "Text": "EXISTING COMPANY BACKGROUND PATENTS", "": "" }, { "Text": "COMPANY OWNED PATENTS:", "": "" }, { "Text": "DOCKET NO.", "": "" }, { "Text": "DFY-001PR", "": "" }, { "Text": "DFY-001WO", "": "" }, { "Text": "DFY-001AU", "": "" }, { "Text": "DFY-001BR", "": "" }, { "Text": "DFY-001CA", "": "" }, { "Text": "DFY-001CN", "": "" }, { "Text": "DFY-001EP", "": "" }, { "Text": "DFY-001HK", "": "" }, { "Text": "DFY-001IL", "": "" }, { "Text": "DFY-001IN", "": "" }, { "Text": "DFY-001JP", "": "" }, { "Text": "DFY-001KR", "": "" }, { "Text": "DFY-001MX", "": "" }, { "Text": "DFY-001RU", "": "" }, { "Text": "DFY-001SA", "": "" }, { "Text": "DFY-001SG", "": "" }, { "Text": "DFY-001ZA", "": "" }, { "Text": "DFY-001", "": "" }, { "Text": "DFY-047PR", "": "" }, { "Text": "DFY-034WO", "": "" }, { "Text": "DFY-034AU", "": "" }, { "Text": "DFY-034BR", "": "" }, { "Text": "DFY-034CA", "": "" }, { "Text": "DFY-034CN", "": "" }, { "Text": "DFY-034EP", "": "" }, { "Text": "DFY-034IL", "": "" }, { "Text": "DFY-034IN", "": "" }, { "Text": "DFY-034JP", "": "" }, { "Text": "DFY-034KR", "": "" }, { "Text": "DFY-034MX", "": "" }, { "Text": "DFY-034RU", "": "" }, { "Text": "DFY-034SA", "": "" }, { "Text": "DFY-034SG", "": "" }, { "Text": "DFY-034", "": "" }, { "Text": "DFY-034ZA", "": "" }, { "Text": "DFY-048PR", "": "" }, { "Text": "DFY-048WO", "": "" }, { "Text": "DFY-048AU", "": "" }, { "Text": "DFY-048BR", "": "" }, { "Text": "DFY-048CA", "": "" }, { "Text": "DFY-048CL", "": "" }, { "Text": "DFY-048CN", "": "" }, { "Text": "DFY-048CO", "": "" }, { "Text": "DFY-048EA", "": "" }, { "Text": "DFY-048EG", "": "" }, { "Text": "DFY-048EP", "": "" }, { "Text": "DFY-048HK", "": "" }, { "Text": "DFY-048IL", "": "" }, { "Text": "DFY-048IN", "": "" }, { "Text": "DFY-048JP", "": "" }, { "Text": "DFY-048KR", "": "" }, { "Text": "DFY-048MX", "": "" }, { "Text": "DFY-048MY", "": "" }, { "Text": "DFY-048NZ", "": "" }, { "Text": "DFY-048PE", "": "" }, { "Text": "DFY-048SA", "": "" }, { "Text": "DFY-048SG", "": "" }, { "Text": "DFY-048TH", "": "" }, { "Text": "DFY-048", "": "" }, { "Text": "DFY-048ZA", "": "" }, { "Text": "DFY-049PR", "": "" }, { "Text": "DFY-049WO", "": "" }, { "Text": "DFY-049AU", "": "" }, { "Text": "DFY-049BR", "": "" }, { "Text": "DFY-049CA", "": "" }, { "Text": "DFY-049CL", "": "" }, { "Text": "DFY-049CN", "": "" }, { "Text": "DFY-049CO", "": "" }, { "Text": "DFY-049EA", "": "" }, { "Text": "DFY-049EG", "": "" }, { "Text": "DFY-049EP", "": "" }, { "Text": "DFY-049HK", "": "" }, { "Text": "DFY-049IL", "": "" }, { "Text": "DFY-049IN", "": "" }, { "Text": "DFY-049JP", "": "" }, { "Text": "DFY-049KR", "": "" }, { "Text": "DFY-049MX", "": "" }, { "Text": "DFY-049MY", "": "" }, { "Text": "DFY-049NZ", "": "" }, { "Text": "DFY-049PE", "": "" }, { 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"Europe", "": "" }, { "Text": "Europe", "": "" }, { "Text": "Eurasia", "": "" }, { "Text": "Israel", "": "" }, { "Text": "India", "": "" }, { "Text": "Japan", "": "" }, { "Text": "US", "": "" }, { "Text": "US", "": "" }, { "Text": "US", "": "" }, { "Text": "Korea", "": "" }, { "Text": "abbvie", "": "" }, { "Text": "Anker Lundermose", "": "" }, { "Text": "Chief Executive Officer", "": "" }, { "Text": "Mission Therapeutics Ltd", "": "" }, { "Text": "McClintock Building", "": "" }, { "Text": "Granta Park", "": "" }, { "Text": "Great Abington", "": "" }, { "Text": "Cambridge, CB21 6GP", "": "" }, { "Text": "United Kingdom", "": "" }, { "Text": "Copy to: Paul Wallace, Chief Business Officer, Mission Therapeutics Ltd", "": "" }, { "Text": "21-Jul-21", "": "" }, { "Text": "Dear Anker", "": "" }, { "Text": "Notice of Selected DUBs", "": "" }, { "Text": "We refer to the Option, Collaboration and License Agreement entered into between Abb Vie Biotechnology Ltd and Mission Therapeutics Ltd dated November 14, 2018 as amended (and together with any amendments, the \"Agreement\"). Terms and expressions used in this letter shall have the same meaning as defined in the Agreement.", "": "" }, { "Text": "Pursuant to Section 3.2(b) of the Agreement, Abb Vie hereby notifies Mission that it selects JOSD2 and USP32 as Selected DUBs.", "": "" }, { "Text": "Sincerely,", "": "" }, { "Text": "anon | Arthur Price", "": "" }, { "Text": "Director", "": "" }, { "Text": "For and on behalf of AbbVie Biotechnology Ltd", "": "" }, { "Text": "Execution Copy", "": "" }, { "Text": "88878677_21", "": "" }, { "Text": "DEVELOPMENT, EXCLUSIVITY AND OPTION PRODUCTS AGREEMENT", "": "" }, { "Text": "By and between", "": "" }, { "Text": "COLLPLANT LTD.", "": "" }, { "Text": "AND", "": "" }, { "Text": "ALLERGAN INDUSTRIE S.A.S.", "": "" }, { "Text": "AND", "": "" }, { "Text": "ALLERGAN PHARMACEUTICALS INTERNATIONAL LIMITED", "": "" }, { "Text": "TABLE OF CONTENTS", "": "" }, { "Text": "Article 1 - DEFINITIONS .............................................................................................................. 2", "": "" }, { "Text": "Article 2 - DEVELOPMENT; RIGHT OF FIRST NEGOTIATION ........................................... 20", "": "" }, { "Text": "2.1 Development Plans ............................................................................................ 20", "": "" }, { "Text": "2.2 Conduct of Development Programs ................................................................... 20", "": "" }, { "Text": "2.3 Right of First Negotiation for Option Products ................................................. 22", "": "" }, { "Text": "2.4 No Additional Israel Innovation Authority Financing; Amendments of IIA Terms ........................................................................................................... 24", "": "" }, { "Text": "2.5 Supply Agreement ............................................................................................. 25", "": "" }, { "Text": "Article 3 - GOVERNANCE.......................................................................................................... 25", "": "" }, { "Text": "3.1 Joint Governance Committee............................................................................. 25", "": "" }, { "Text": "3.2 Responsibilities .................................................................................................. 25", "": "" }, { "Text": "3.3 Meetings and Minutes ........................................................................................ 26", "": "" }, { "Text": "3.4 Procedural Rules ................................................................................................ 26", "": "" }, { "Text": "3.5 Decision-Making ............................................................................................... 26", "": "" }, { "Text": "3.6 Interactions Between a Committee and Internal Teams .................................... 27", "": "" }, { "Text": "3.7 Expenses ............................................................................................................ 27", "": "" }, { "Text": "3.8 Authority ............................................................................................................ 27", "": "" }, { "Text": "Article 4 - EXCLUSIVITY RIGHTS ........................................................................................... 28", "": "" }, { "Text": "4.1 Grant of Exclusive Rights to AbbVie ................................................................ 28", "": "" }, { "Text": "4.2 Grant of Evaluation Rights to AbbVie .............................................................. 28", "": "" }, { "Text": "4.3 Limitations on CollPlant .................................................................................... 28", "": "" }, { "Text": "4.4 Covenant Not to Sue .......................................................................................... 28", "": "" }, { "Text": "4.5 Grant of Right of Reference to AbbVie ............................................................. 29", "": "" }, { "Text": "4.6 CollPlant Right to Sell OTC Skincare Products ................................................ 29", "": "" }, { "Text": "Article 5 - GENERAL PROVISIONS RELATING TO ACTIVITIES........................................ 29", "": "" }, { "Text": "5.1 AbbVie Development and Commercialization .................................................. 29", "": "" }, { "Text": "5.2 AbbVie Diligence Obligations........................................................................... 30", "": "" }, { "Text": "5.3 Compliance ........................................................................................................ 30", "": "" }, { "Text": "5.4 Subcontracting ................................................................................................... 30", "": "" }, { "Text": "5.5 Records and Audits ............................................................................................ 30", "": "" }, { "Text": "5.6 Cooperation ........................................................................................................ 31", "": "" }, { "Text": "Article 6 - FINANCIAL TERMS; PAYMENTS.......................................................................... 31", "": "" }, { "Text": "6.1 Upfront Fee ........................................................................................................ 31", "": "" }, { "Text": "6.2 Option Exercise Fee ........................................................................................... 31", "": "" }, { "Text": "6.3 Contingent Payments ......................................................................................... 32", "": "" }, { "Text": "6.4 Milestone Payments ........................................................................................... 32", "": "" }, { "Text": "6.5 Royalties ............................................................................................................ 35", "": "" }, { "Text": "6.6 Royalty Term ..................................................................................................... 36", "": "" }, { "Text": "6.7 Royalty Adjustments.......................................................................................... 36", "": "" }, { "Text": "6.8 Reports; Payment of Royalty ............................................................................. 37", "": "" }, { "Text": "6.9 Financial Records .............................................................................................. 38", "": "" }, { "Text": "6.10 Audit; Audit Dispute .......................................................................................... 38", "": "" }, { "Text": "6.11 Methods of Payments; Offsets ........................................................................... 39", "": "" }, { "Text": "6.12 Taxes .................................................................................................................. 39", "": "" }, { "Text": "6.13 Late Payments .................................................................................................... 40", "": "" }, { "Text": "6.14 Financial Obligations under In-License Agreements ........................................ 40", "": "" }, { "Text": "Article 7 - INTELLECTUAL PROPERTY RIGHTS .................................................................. 40", "": "" }, { "Text": "7.1 Ownership of Intellectual Property; Disclosure................................................. 40", "": "" }, { "Text": "7.2 Patent Prosecution and Maintenance ................................................................. 42", "": "" }, { "Text": "7.3 Enforcement of Patent Rights ............................................................................ 43", "": "" }, { "Text": "7.4 Infringement Claims by Third Parties ............................................................... 44", "": "" }, { "Text": "7.5 Invalidity or Unenforceability Defenses or Actions .......................................... 45", "": "" }, { "Text": "7.6 Product Trademarks ........................................................................................... 45", "": "" }, { "Text": "7.7 Inventor's Remuneration ................................................................................... 46", "": "" }, { "Text": "7.8 International Nonproprietary Name ................................................................... 46", "": "" }, { "Text": "Article 8 - CONFIDENTIALITY ................................................................................................. 46", "": "" }, { "Text": "8.1 Product Information ........................................................................................... 46", "": "" }, { "Text": "8.2 Confidentiality Obligations ............................................................................... 47", "": "" }, { "Text": "8.3 Permitted Disclosures. Each Party may disclose Confidential Information to the extent that such disclosure is: .............................................. 48", "": "" }, { "Text": "8.4 Use of Name ...................................................................................................... 49", "": "" }, { "Text": "8.5 Public Announcements ...................................................................................... 50", "": "" }, { "Text": "8.6 Publications ........................................................................................................ 50", "": "" }, { "Text": "8.7 Return of Confidential Information ................................................................... 50", "": "" }, { "Text": "8.8 Survival .............................................................................................................. 50", "": "" }, { "Text": "Article 9 - REPRESENTATIONS AND WARRANTIES ........................................................... 51", "": "" }, { "Text": "9.1 Representations and Warranties of Both Parties................................................ 51", "": "" }, { "Text": "9.2 Representations, Warranties and Covenants, as applicable, of CollPlant ......... 52", "": "" }, { "Text": "9.3 Mutual Covenants .............................................................................................. 56", "": "" }, { "Text": "9.4 Additional Covenants of CollPlant .................................................................... 56", "": "" }, { "Text": "9.5 Disclaimer .......................................................................................................... 57", "": "" }, { "Text": "9.6 Anti-Bribery and Anti-Corruption Compliance ................................................. 57", "": "" }, { "Text": "Article 10 - INDEMNIFICATION; INSURANCE ...................................................................... 57", "": "" }, { "Text": "10.1 Indemnification by AbbVie ............................................................................... 57", "": "" }, { "Text": "10.2 Indemnification by CollPlant ............................................................................. 58", "": "" }, { "Text": "10.3 Procedure ........................................................................................................... 59", "": "" }, { "Text": "10.4 Insurance ............................................................................................................ 61", "": "" }, { "Text": "10.5 Limitation of Liability ....................................................................................... 62", "": "" }, { "Text": "Article 11 - TERM AND TERMINATION .................................................................................. 62", "": "" }, { "Text": "11.1 Term ................................................................................................................... 62", "": "" }, { "Text": "11.2 Termination ........................................................................................................ 62", "": "" }, { "Text": "11.3 Modification in Lieu of Termination ................................................................. 63", "": "" }, { "Text": "11.4 Effects of Termination of Agreement ................................................................ 64", "": "" }, { "Text": "11.5 Effects of Termination in Terminated Territory ................................................ 64", "": "" }, { "Text": "11.6 Accrued Rights; Surviving Provisions of the Agreement .................................. 64", "": "" }, { "Text": "Article 12 - MISCELLANEOUS .................................................................................................. 65", "": "" }, { "Text": "12.1 Governing Law; Service .................................................................................... 65", "": "" }, { "Text": "12.2 Dispute Resolution ............................................................................................. 66", "": "" }, { "Text": "12.3 Assignment ........................................................................................................ 66", "": "" }, { "Text": "12.4 Force Majeure .................................................................................................... 67", "": "" }, { "Text": "12.5 Notices ............................................................................................................... 68", "": "" }, { "Text": "12.6 Export Clause ..................................................................................................... 69", "": "" }, { "Text": "12.7 Waiver; Non-Exclusion of Remedies ................................................................ 69", "": "" }, { "Text": "12.8 No Benefit to Third Parties ................................................................................ 69", "": "" }, { "Text": "12.9 Further Assurance .............................................................................................. 70", "": "" }, { "Text": "12.10 Severability ........................................................................................................ 70", "": "" }, { "Text": "12.11 Equitable Relief ................................................................................................. 70", "": "" }, { "Text": "12.12 Entire Agreement; Amendments ....................................................................... 70", "": "" }, { "Text": "12.13 Relationship of the Parties ................................................................................. 71", "": "" }, { "Text": "12.14 Headings; Construction; Interpretation .............................................................. 71", "": "" }, { "Text": "12.15 Books and Records ............................................................................................ 72", "": "" }, { "Text": "12.16 English Language .............................................................................................. 72", "": "" }, { "Text": "12.17 Parties in Interest ............................................................................................... 72", "": "" }, { "Text": "12.18 Counterparts ....................................................................................................... 72", "": "" }, { "Text": "EXHIBITS AND SCHEDULES", "": "" }, { "Text": "Exhibit A CollPlant Collagen", "": "" }, { "Text": "Exhibit B Sterile 20 Project Development Plan", "": "" }, { "Text": "Exhibit C Sterile 50 Project Development Plan", "": "" }, { "Text": "Exhibit D Lyophilized Low Bioburden Project Development Plan", "": "" }, { "Text": "Exhibit E Specifications", "": "" }, { "Text": "Schedule 1.26 CollPlant Patents", "": "" }, { "Text": "Schedule 2.5 Supply Agreement Term Sheet", "": "" }, { "Text": "Schedule 9.2 CollPlant Disclosure Schedule", "": "" }, { "Text": "Schedule 9.2.3 Existing Patent Rights", "": "" }, { "Text": "Schedule 9.2.10 Disputes", "": "" }, { "Text": "Schedule 9.2.16 Use of Academic Facilities and Personnel", "": "" }, { "Text": "Schedule 12.2.2 ADR", "": "" }, { "Text": "DEVELOPMENT, EXCLUSIVITY AND OPTION PRODUCTS AGREEMENT", "": "" }, { "Text": "This DEVELOPMENT, EXCLUSIVITY AND OPTION PRODUCTS AGREEMENT (this \"Agreement\") is entered into and made effective as of February 5, 2021 (the \"Effective Date\"), by and between, on the one hand, CollPlant Ltd., an Israeli company, having its principal place of business at Oppenheimer 4 Rehovot, Israel (\"CollPlant\"), and, on the other hand, Allergan Industrie S.A.S., a company registered in France, having its registered office at Route de Promery, Zone Artisanale de Pre-Mairy, 74370 Pringy, France (\"AbbVie\") and, solely for the purpose of Section 2.3 (Right of First Negotiation for Option Products), Section 6.1 (Upfront Fee), Section 6.2 (Option Exercise Fee), Section 7.3.4 (Option Products) and the terms of Section 6.4 (Milestone Payments) through Section 6.7 (Royalty Adjustments) that specifically apply to APIL, Allergan Pharmaceuticals International Limited, an Ireland private company limited by shares, with a place of business at Clonshaugh Industrial Estate, Coolock, Dublin 17 E400, Ireland (\"APIL\"). CollPlant and AbbVie (and, solely for the purpose of Section 2.3 (Right of First Negotiation for Option Products), Section 6.1 (Upfront Fee), Section 6.2 (Option Exercise Fee), Section 7.3.4 (Option Products) and the terms of Section 6.4 (Milestone Payments) through Section 6.7 (Royalty Adjustments) that specifically apply to APIL, APIL) shall be referred to herein individually as a \"Party\" and collectively as the \"Parties\".", "": "" }, { "Text": "RECITALS", "": "" }, { "Text": "WHEREAS, CollPlant is a regenerative and aesthetic medicine company developing technologies and products for tissue regeneration, including the CollPlant Collagen;", "": "" }, { "Text": "WHEREAS, AbbVie and its Affiliates possess expertise in the research, development, manufacturing and commercialization of human pharmaceuticals and devices, including medical aesthetics;", "": "" }, { "Text": "WHEREAS, CollPlant and AbbVie desire to engage in a collaborative effort in which CollPlant will carry out certain development activities set forth in the Development Plans (as defined herein);", "": "" }, { "Text": "WHEREAS, AbbVie desires to acquire from CollPlant and CollPlant desires to grant to AbbVie the Exclusivity Rights (as defined herein), and CollPlant desires to grant to AbbVie a right of first negotiation for Option Products (as defined herein), in each case as set forth in, and subject to the terms of, this Agreement; and", "": "" }, { "Text": "WHEREAS, the Parties will enter into the Supply Agreement (as defined herein) in accordance with the terms of this Agreement, and CollPlant will supply CollPlant Collagen to AbbVie in accordance with the terms of the Supply Agreement.", "": "" }, { "Text": "NOW, THEREFORE, in consideration of the premises and mutual covenants herein contained, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:", "": "" }, { "Text": "ARTICLE 1 - DEFINITIONS", "": "" }, { "Text": "As used in this Agreement, the following terms will have the meanings set forth in this Article 1 - (Definitions) unless context dictates otherwise:", "": "" }, { "Text": "1.1 \"AbbVie\" has the meaning set forth in the Preamble.", "": "" }, { "Text": "1.2 \"Accounting Standards\" means, with respect to a Party or its Affiliates or its or their (sub)licensees, United States generally accepted accounting principles or International Financial Reporting Standards as issued by the International Accounting Standards Board, as applicable, in each case consistently applied.", "": "" }, { "Text": "CONFIDENTIAL - Final 02.21.2020", "": "" }, { "Text": "AMENDED AND RESTATED LICENSE AGREEMENT", "": "" }, { "Text": "between", "": "" }, { "Text": "ALLERGAN SALES, LLC", "": "" }, { "Text": "and", "": "" }, { "Text": "FSV7, LLC", "": "" }, { "Text": "Dated as of February 21, 2020", "": "" }, { "Text": "TABLE OF CONTENTS", "": "" }, { "Text": "ARTICLE 1 DEFINITIONS ...................................................................................................... 1", "": "" }, { "Text": "ARTICLE 2 GRANT OF RIGHTS .......................................................................................... 16", "": "" }, { "Text": "2.1 Grants to Licensee.................................................................................. 16", "": "" }, { "Text": "2.2 Intentionally Omitted ............................................................................. 17", "": "" }, { "Text": "2.3 Retention of Rights; Passive Sales .......................................................... 17", "": "" }, { "Text": "2.4 Sublicenses ............................................................................................ 17", "": "" }, { "Text": "2.5 No Implied Rights .................................................................................. 17", "": "" }, { "Text": "2.6 Intentionally Omitted ............................................................................. 18", "": "" }, { "Text": "2.7 Technology Transfer and Cooperation.................................................... 18", "": "" }, { "Text": "2.8 Intentionally Omitted ............................................................................. 18", "": "" }, { "Text": "2.9 In-License Agreements .......................................................................... 18", "": "" }, { "Text": "2.10 Covenant Not to Sue .............................................................................. 18", "": "" }, { "Text": "ARTICLE 3 DEVELOPMENT AND REGULATORY ........................................................... 19", "": "" }, { "Text": "3.1 Development. ......................................................................................... 19", "": "" }, { "Text": "3.2 Regulatory Matters ................................................................................. 19", "": "" }, { "Text": "3.3 Reports .................................................................................................. 20", "": "" }, { "Text": "3.4 Records .................................................................................................. 20", "": "" }, { "Text": "3.5 Subcontracting; Licensed Product Agreements ....................................... 20", "": "" }, { "Text": "3.6 Compliance ............................................................................................ 21", "": "" }, { "Text": "3.7 Right of First Negotiation....................................................................... 21", "": "" }, { "Text": "3.8 Global Safety Database .......................................................................... 22", "": "" }, { "Text": "ARTICLE 4 COMMERCIALIZATION .................................................................................. 22", "": "" }, { "Text": "4.1 In General .............................................................................................. 22", "": "" }, { "Text": "4.2 Commercialization Plan ......................................................................... 22", "": "" }, { "Text": "4.3 Diligence ............................................................................................... 22", "": "" }, { "Text": "4.4 Compliance with Applicable Law .......................................................... 22", "": "" }, { "Text": "4.5 Sales and Distribution ............................................................................ 22", "": "" }, { "Text": "4.6 Product Trademarks ............................................................................... 23", "": "" }, { "Text": "4.7 Manufacture and Supply ........................................................................ 23", "": "" }, { "Text": "4.8 Subcontracting ....................................................................................... 23", "": "" }, { "Text": "ARTICLE 5 PAYMENTS ....................................................................................................... 23", "": "" }, { "Text": "5.1 Upfront and Allergan Agreements Payments .......................................... 23", "": "" }, { "Text": "5.2 Royalties ................................................................................................ 24", "": "" }, { "Text": "5.3 Sublicense Revenue ............................................................................... 24", "": "" }, { "Text": "5.4 Mode of Payment; Currency Conversion ................................................ 25", "": "" }, { "Text": "5.5 Taxes ................................................................................................... 26", "": "" }, { "Text": "5.6 Value Added Tax ................................................................................... 27", "": "" }, { "Text": "5.7 Interest on Late Payments ...................................................................... 27", "": "" }, { "Text": "5.8 Financial Records................................................................................... 27", "": "" }, { "Text": "5.9 Audit ................................................................................................... 27", "": "" }, { "Text": "5.10 Audit Dispute ......................................................................................... 28", "": "" }, { "Text": "5.11 Confidentiality ....................................................................................... 28", "": "" }, { "Text": "ARTICLE 6 INTELLECTUAL PROPERTY .......................................................................... 28", "": "" }, { "Text": "6.1 Ownership of Intellectual Property ......................................................... 28", "": "" }, { "Text": "6.2 Prosecution and Maintenance of Patents ................................................. 30", "": "" }, { "Text": "6.3 Enforcement of Patents .......................................................................... 31", "": "" }, { "Text": "6.4 Infringement Claims by Third Parties ..................................................... 32", "": "" }, { "Text": "6.5 Invalidity or Unenforceability Defenses or Actions ................................ 33", "": "" }, { "Text": "6.6 Third Party Licenses .............................................................................. 34", "": "" }, { "Text": "6.7 Product Trademarks ............................................................................... 34", "": "" }, { "Text": "ARTICLE 7 CONFIDENTIALITY AND NON-DISCLOSURE ............................................. 35", "": "" }, { "Text": "7.1 Confidentiality Obligations .................................................................... 35", "": "" }, { "Text": "7.2 Permitted Disclosures............................................................................. 36", "": "" }, { "Text": "7.3 Use of Name .......................................................................................... 37", "": "" }, { "Text": "7.4 Press Releases ........................................................................................ 37", "": "" }, { "Text": "7.5 Publications ........................................................................................... 37", "": "" }, { "Text": "7.6 Return or Destruction of Confidential Information ................................. 38", "": "" }, { "Text": "ARTICLE 8 REPRESENTATIONS AND WARRANTIES .................................................... 38", "": "" }, { "Text": "8.1 Mutual Representations and Warranties ................................................. 38", "": "" }, { "Text": "8.2 Debarment ............................................................................................. 39", "": "" }, { "Text": "8.3 Additional Representations of Allergan .................................................. 39", "": "" }, { "Text": "8.4 Intentionally Omitted ............................................................................. 40", "": "" }, { "Text": "8.5 DISCLAIMER OF WARRANTY .......................................................... 40", "": "" }, { "Text": "8.6 ADDITIONAL WAIVER ...................................................................... 40", "": "" }, { "Text": "ARTICLE 9 INDEMNITY ...................................................................................................... 41", "": "" }, { "Text": "9.1 Indemnification of Allergan ................................................................... 41", "": "" }, { "Text": "9.2 Indemnification of Licensee ................................................................... 41", "": "" }, { "Text": "9.3 Notice of Claim ...................................................................................... 41", "": "" }, { "Text": "9.4 Control of Defense ................................................................................. 42", "": "" }, { "Text": "9.5 Limitation on Damages and Liability ..................................................... 43", "": "" }, { "Text": "9.6 Insurance ............................................................................................... 44", "": "" }, { "Text": "ARTICLE 10 TERM AND TERMINATION .......................................................................... 44", "": "" }, { "Text": "10.1 Term ................................................................................................... 44", "": "" }, { "Text": "10.2 Termination of this Agreement for Material Breach ............................... 45", "": "" }, { "Text": "10.3 Termination by Allergan ........................................................................ 45", "": "" }, { "Text": "10.4 Intentionally Omitted ............................................................................. 46", "": "" }, { "Text": "10.5 Termination at Will by Licensee ............................................................ 46", "": "" }, { "Text": "10.6 Intentionally Omitted ............................................................................. 46", "": "" }, { "Text": "10.7 Termination Upon Insolvency ................................................................ 46", "": "" }, { "Text": "10.8 Rights in Bankruptcy ............................................................................. 46", "": "" }, { "Text": "10.9 Consequences of Termination ................................................................ 47", "": "" }, { "Text": "10.10 Intentionally Omitted ............................................................................. 49", "": "" }, { "Text": "10.11 Accrued Rights; Surviving Obligations .................................................. 49", "": "" }, { "Text": "ARTICLE 11 MISCELLANEOUS .......................................................................................... 50", "": "" }, { "Text": "11.1 Force Majeure ........................................................................................ 50", "": "" }, { "Text": "11.2 Intentionally Omitted ............................................................................. 51", "": "" }, { "Text": "11.3 Export Control ....................................................................................... 51", "": "" }, { "Text": "11.4 Assignment ............................................................................................ 51", "": "" }, { "Text": "11.5 Severability ............................................................................................ 51", "": "" }, { "Text": "11.6 Dispute Resolution ................................................................................. 52", "": "" }, { "Text": "11.7 Governing Law and Service ................................................................... 52", "": "" }, { "Text": "11.8 Notices ................................................................................................... 52", "": "" }, { "Text": "11.9 Entire Agreement; Amendments ............................................................ 53", "": "" }, { "Text": "11.10 English Language................................................................................... 54", "": "" }, { "Text": "11.11 Equitable Relief ..................................................................................... 54", "": "" }, { "Text": "11.12 Waiver and Non-Exclusion of Remedies ................................................ 54", "": "" }, { "Text": "11.13 No Benefit to Third Parties..................................................................... 54", "": "" }, { "Text": "11.14 Further Assurance .................................................................................. 54", "": "" }, { "Text": "11.15 Relationship of the Parties ...................................................................... 55", "": "" }, { "Text": "11.16 Counterparts........................................................................................... 55", "": "" }, { "Text": "11.17 References ............................................................................................. 55", "": "" }, { "Text": "11.18 Construction........................................................................................... 55", "": "" }, { "Text": "Schedules", "": "" }, { "Text": "Schedule 1.6 Allergan Agreements", "": "" }, { "Text": "Schedule 1.60 Allergan Employees", "": "" }, { "Text": "Schedule 1.64 Licensed Patents", "": "" }, { "Text": "Schedule 2.7.1 Technology Disclosures", "": "" }, { "Text": "Schedule 2.7.2 Transferred Compounds", "": "" }, { "Text": "Schedule 3.2 FDA Letters", "": "" }, { "Text": "AMENDED AND RESTATED LICENSE AGREEMENT", "": "" }, { "Text": "This Amended and Restated License Agreement (this \"Agreement\") is made and entered into effective as of February 21, 2020 (the \"Effective Date\") by and between Allergan Sales, LLC, a Delaware limited liability company (\"Allergan\") and FSV7, LLC, a Delaware limited liability company (\"Licensee\"). Allergan and Licensee are sometimes referred to herein individually as a \"Party\" and collectively as the \"Parties.", "": "" }, { "Text": "RECITALS", "": "" }, { "Text": "WHEREAS, Allergan controls certain intellectual property rights with respect to the Licensed Compound (as defined herein) and Licensed Products (as defined herein) in the Territory (as defined herein); and", "": "" }, { "Text": "WHEREAS, the Parties entered into that certain License Agreement, dated, June 30, 2018 (the \"Original Effective Date\"), pursuant to which Allergan granted Licensee a license under such intellectual property rights to Develop (as defined herein), Manufacture (as defined herein) and Commercialize (as defined herein) Licensed Products in the Field (as defined herein) in the Territory (the \"Original License Agreement\").", "": "" }, { "Text": "WHEREAS, the Parties desired to amend and restated in its entirety the Original License Agreement as set forth in this Agreement below.", "": "" }, { "Text": "NOW, THEREFORE, in consideration of the premises and the mutual promises and conditions hereinafter set forth, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, do hereby agree as follows:", "": "" }, { "Text": "ARTICLE 1 DEFINITIONS", "": "" }, { "Text": "Unless otherwise specifically provided herein, the following terms shall have the following meanings:", "": "" }, { "Text": "1.1 \"Accountant\" has the meaning set forth in Section 5.10.", "": "" }, { "Text": "1.2 \"Administrative Proceeding\" has the meaning set forth in Section 6.2.", "": "" }, { "Text": "1.3 \"Affiliate\" means, with respect to a Person, any other Person that at any time during the Term, directly or indirectly, through one or more intermediaries, controls, is controlled by or is under common control with such Person, but for only so long as such control exists. For purposes of this definition, \"control\" and, with correlative meanings, the terms \"controlled by\" and \"under common control with\" means (a) the possession, directly or indirectly, of the power to direct the management or policies of a business entity, whether through the ownership of voting securities, by contract relating to voting rights or corporate governance, or otherwise, or (b) the ownership, directly or indirectly, of more than 50% of the voting securities or other ownership interest of a business entity (or, with respect to a limited partnership or other similar entity, its general partner or controlling entity).", "": "" }, { "Text": "1.4 \"Agreement\" has the meaning set forth in the preamble hereto.", "": "" }, { "Text": "1.5 \"Allergan\" has the meaning set forth in the preamble hereto.", "": "" }, { "Text": "1.6 \"Allergan Agreements\" means each agreement, contract or arrangement between Allergan or its Affiliates, on the one hand, and a Third Party, on the other hand, relating to the Licensed Compound or a Licensed Product and under which Allergan or its Affiliates have any payment obligations to such Third Party, which agreements are set forth on Schedule 1.6 (which schedule may be modified from time to time with the agreement of the Parties).", "": "" }, { "Text": "1.7 \"Allergan Indemnitees\" has the meaning set forth in Section 9.1.", "": "" }, { "Text": "1.8 \"Allergan Regulatory Documentation\" means all Regulatory Documentation developed by Allergan or any of its Affiliates or licensees as of the Effective Date that is Controlled by Allergan or its Affiliates and is necessary or reasonably useful for the Exploitation of the Licensed Compound or a Licensed Product in the Field in the Territory. Allergan Regulatory Documentation shall be limited to Regulatory Documentation relating to the Licensed Products in the Field in such form as such Licensed Products exist as of the Effective Date and shall not include any Regulatory Documentation relating to any modification or enhancement included in, made to or used with, or any active ingredient combined in or used with, such Licensed Products (e.g. any formulation or delivery system).", "": "" }, { "Text": "1.9 \"Applicable Law\" means applicable laws, rules and regulations, including any rules, regulations, guidelines or other requirements of the Regulatory Authorities, that may be in effect from time to time.", "": "" }, { "Text": "1.10 \"Breaching Party\" has the meaning set forth in Section 10.2.", "": "" }, { "Text": "1.11 \"Business Day\" means a day, other than a Saturday or Sunday, on which banking institutions in New York, NY are not closed.", "": "" }, { "Text": "1.12 \"Calendar Quarter\" means each successive period of three calendar months commencing on January 1, April 1, July 1 and October 1.", "": "" }, { "Text": "1.13 \"Calendar Year\" means each successive period of 12 calendar months commencing on January 1 and ending on December 31.", "": "" }, { "Text": "1.14 \"Change of Control\" means any of the following occurs after the Effective Date:", "": "" }, { "Text": "1.14.1 any \"person\" or \"group\" (as such terms are defined below) becomes the \"beneficial owner\" (as defined below) of securities of a Relevant Entity representing more than (a) 50% of all outstanding securities of such Relevant Entity, or (b) 50% of the voting power with respect to the election of members of the board of directors (or analogous governing body) of such Relevant Entity, other than in the case of a Qualified Financing;", "": "" }, { "Text": "1.14.2 any transaction, or series of related transactions, involving a Relevant Entity, in each case other than a Qualified Financing, that results in (a) the members of the board of directors (or analogous governing body) of such Relevant Entity immediately prior to such transaction or transactions constituting less than a majority of the members of the board of directors (or analogous governing body) of such Relevant Entity or the surviving entity in such transaction or transactions, as the case may be, immediately following such transaction or transactions or (b) the Persons who beneficially owned the outstanding equity securities of such Relevant Entity immediately prior to such transaction or transactions ceasing to beneficially own securities of such Relevant Entity representing more than 50% of both (i) all outstanding equity securities of such Relevant Entity and (ii) the voting power with respect to the election of members of the board of directors (or analogous governing body) of such Relevant Entity immediately following such transaction or transactions;", "": "" }, { "Text": "1.14.3 any Relevant Entity sells, transfers or assigns to any Third Party, in one or more related transactions, properties or assets (a) representing all or a substantial portion of such Relevant Entity's consolidated total assets that relate to this Agreement, the Licensed Patents, the Licensed Know-How, the Joint Patents, the Joint Know-How, the Licensed Compound and the Licensed Products or (b) from which more than 50% of such Relevant Entity's net sales for its most recent fiscal year was derived; or", "": "" }, { "Text": "1.14.4 the holders of equity interests of any Relevant Entity approve a plan or proposal for the liquidation or dissolution of such Relevant Entity.", "": "" }, { "Text": "For the purpose of this definition of Change of Control, (a) \"person\" and \"group\" have the meanings given such terms under Section 13(d) and 14(d) of the United States Securities Exchange Act of 1934, as amended (the \"Exchange Act\"), and the term \"group\" includes any group acting for the purpose of acquiring, holding or disposing of securities within the meaning of Rule 13d-5(b)(1) under the Exchange Act, (b) a \"beneficial owner\" shall be determined in accordance with Rule 13d-3 under the Exchange Act, and (c) the terms \"beneficially owned\" and \"beneficially own\" shall have meanings correlative to that of \"beneficial owner.", "": "" }, { "Text": "1.15 \"Clinical Trials\" means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product that are conducted in human subjects.", "": "" }, { "Text": "1.16 \"Commercialization\" means, with respect to a Licensed Product, any and all activities (whether before or after Regulatory Approval) directed to the marketing, promotion and sale of such Licensed Product in the Field in the Territory after Regulatory Approval for commercial sale has been obtained, including pre-launch and post-launch marketing, promoting, marketing research, distributing, offering to commercially sell and commercially selling such Licensed Product, importing, exporting or transporting such Licensed Product for commercial sale, medical education activities with respect to such Licensed Product, conducting Clinical Trials that are not required to obtain or maintain Regulatory Approval for such Licensed Product for an indication, which may include epidemiological studies, modeling and pharmacoeconomic studies, post-marketing surveillance studies, investigator sponsored studies and health economics studies and regulatory affairs (including interacting with Regulatory Authorities) with respect to the foregoing. When used as a verb, \"Commercializing\" means to engage in Commercialization and \"Commercialize\" and \"Commercialized\" shall have corresponding meanings.", "": "" }, { "Text": "1.17 \"Commercialization Plan\" means a high-level, non-binding, multi-year plan for the Commercialization of the Licensed Products in the Field in the Territory, which shall include a high-level overview of: (a) general strategies for promoting, marketing and distributing the Licensed Products in the Field in the United States; (b) pre-launch Commercialization activities and the expected date of launch of each Licensed Product in the United States; (c) the nature of promotional activities anticipated with respect to the Licensed Products in the Field in the United States; (d) non-binding summary-level market and sales forecasts for the Licensed Products in the Field in the United States; and (e) a non-binding projection of Net Sales for Licensed Products in the Field in the United States.", "": "" }, { "Text": "1.18 \"Commercially Reasonable Efforts\" means with respect to a Party, the level of efforts and resources comparable to the efforts and resources that such Party would typically devote to compounds or products of similar market potential at a similar stage in development or product life, including any payments owed by such Party to the other Party under this Agreement and, with respect to Allergan, other product opportunities of Allergan; provided that in no event shall the level of efforts and resources of Licensee be less than the efforts and resources commonly used in the biotech industry by venture-backed, single product companies with internally-developed products.", "": "" }, { "Text": "1.19 \"Complaining Party\" has the meaning set forth in Section 10.2.", "": "" }, { "Text": "1.20 \"Confidential Information\" has the meaning set forth in Section 7.1.", "": "" }, { "Text": "1.21 \"Control\" means, with respect to any Information, Regulatory Documentation, Patent, or other intellectual property right, possession of the right, whether directly or indirectly, and whether by ownership, license or otherwise (other than by operation of the licenses and other grants in Section 2.1), to assign or grant a license, sublicense or other right to or under such Information, Regulatory Documentation, Patent, or other intellectual property right as provided for herein without violating the terms of any agreement or other arrangement with any Third Party.", "": "" }, { "Text": "1.22 \"Controlling Affiliate\" means any Person that at any time during the Term, directly or indirectly, through one or more intermediaries, controls Parent, the Licensee or any Subject Affiliate, but for only so long as such control exists. For purposes of this definition, \"control\" means (a) the possession, directly or indirectly, of the power to direct the management or policies of a business entity, whether through the ownership of voting securities, by contract relating to voting rights or corporate governance, or otherwise, or (b) the ownership, directly or indirectly, of more than 50% of the voting securities or other ownership interest of a business entity (or, with respect to a limited partnership or other similar entity, its general partner or controlling entity).", "": "" }, { "Text": "1.23 \"Controlling Party\" has the meaning set forth in Section 6.4.1.", "": "" }, { "Text": "1.24 \"Cover\", \"Covering\" or \"Covered\" means, with respect to a Licensed Product in a country, that the manufacture, use, sale, offer for sale, or importation of such Licensed Product in or into such country would, in the absence of a license under a Licensed Patent, infringe a Valid Claim of a Licensed Patent (and for any Licensed Patents that are patent applications, assuming such patent applications were to issue as patents with such claims as are then being prosecuted, would infringe such issued Licensed Patent application) in such country.", "": "" }, { "Text": "1.25 \"Development\" means, with respect to a Licensed Product, all activities related to research, preclinical and other non-clinical testing, test method development and stability testing, toxicology, formulation, Manufacture Process Development, Clinical Trials, including Manufacturing in support thereof (but excluding any commercial Manufacturing), statistical analysis and report writing, the preparation and submission of Drug Approval Applications, regulatory affairs with respect to the foregoing and all other activities necessary or reasonably useful or otherwise requested or required by a Regulatory Authority as a condition or in support of obtaining or maintaining a Regulatory Approval for such Licensed Product. When used as a verb, \"Develop\" means to engage in Development.", "": "" }, { "Text": "1.26 \"Disclosing Party\" has the meaning set forth in Section 7.1.", "": "" }, { "Text": "1.27 \"Disposition Proceeds\" means (i) in the case of a Change of Control described in Section 1.14.2 involving Licensee, the aggregate amount of all payments and consideration received by Licensee or any of its direct or indirect equityholders in connection with such transaction or series of related transactions, and (ii) with respect to any other sale, assignment or transfer (other than a Sublicense Grant) by Licensee or any of its Affiliates to any Person other than an Affiliate of Licensee of any right, title or interest in or to the Licensed Patents, the Licensed Know-How, the Joint Patents, the Joint Know-How, the Licensed Compound or any Licensed Product (for instance, through sale, assignment or transfer of such rights to certain territories or for certain indications), the aggregate amount of all payments and consideration received by Licensee or any Affiliate or any of their respective direct or indirect equityholders in connection with such sale, transfer or assignment. For purposes of this definition, any deferred or contingent consideration, such as milestone payments, shall be calculated as and when such payments become due and payable.", "": "" }, { "Text": "1.28 \"Dispute\" has the meaning set forth in Section 11.6.1.", "": "" }, { "Text": "1.29 \"Distributor\" means any Person(s) (other than a Sublicensee) appointed by Licensee, its Sublicensees or any of its or their Affiliates to distribute, market and sell Licensed Product(s), with or without packaging rights, in one or more countries in the Territory, in circumstances where the Person purchases its requirements of Licensed Product(s) from Licensee or its Sublicensees or its or their Affiliates. Distributors shall not include Persons that (a) distribute pharmaceutical products to pharmacies, hospitals and health systems but do not have primary responsibility for marketing or obtaining and maintaining regulatory approval for the pharmaceutical products it distributes and (b) are used by pharmaceutical companies generally in such country to distribute their products (e.g., Cardinal, McKesson).", "": "" }, { "Text": "1.30 \"Dollars\" or \"$\" means United States Dollars.", "": "" }, { "Text": "1.31 \"Drug Approval Application\" means a New Drug Application (an \"NDA\") as defined in the FFDCA and the regulations promulgated thereunder (including all additions, supplements, extensions and modifications thereto), or any corresponding foreign application in the Territory, including, with respect to the European Union, a Marketing Authorization Application (an \"MAA\") filed with the EMA pursuant to the centralized approval procedure or with the applicable Regulatory Authority of a country in Europe with respect to the mutual recognition or any other national approval procedure.", "": "" }, { "Text": "1.32 \"Effective Date\" has the meaning set forth in the preamble hereto.", "": "" }, { "Text": "1.33 \"EMA\" means the European Medicines Agency and any successor agency thereto.", "": "" }, { "Text": "1.34 \"Europe\" means the countries comprising the European Economic Area as it may be constituted from time to time, which as of the Effective Date consists of the member countries of the European Union, Iceland, Norway, Liechtenstein and Switzerland.", "": "" }, { "Text": "1.35 \"European Union\" means the economic, scientific and political organization of member states as it may be constituted from time to time, which as of the Effective Date consists of Austria, Belgium, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom of Great Britain and Northern Ireland and that certain portion of Cyprus included in such organization. For avoidance of doubt, European Union includes the United Kingdom and any other country that is a member of the European Union on the Effective Date even if such country ceases to be a member of the European Union during the Term.", "": "" }, { "Text": "1.36 \"Executive Officers\" means the Chief Executive Officer of Licensee and the Senior Vice President, Research and External Science and Innovation of Allergan.", "": "" }, { "Text": "1.37 \"Exploit\" means, with respect to a Licensed Product, to make, have made, import, use, sell or offer for sale, including to research, Develop, Commercialize, register, Manufacture, have Manufactured, hold or keep (whether for disposal or otherwise), have used, export, transport, distribute, promote, market or have sold or otherwise dispose of such Licensed Product and \"Exploitation\" means the act of Exploiting a Licensed Product.", "": "" }, { "Text": "1.38 \"FDA\" means the United States Food and Drug Administration and any successor agency thereto.", "": "" }, { "Text": "1.39 \"FFDCA\" means the United States Food, Drug, and Cosmetic Act, as amended from time to time.", "": "" }, { "Text": "1.40 \"Field\" means all fields, including the treatment of diseases and conditions of the central nervous system covering functional retraining, cognition, and psychological retraining, which includes Alzheimer's disease, cognitive disorders, depression, traumatic brain injury, amblyopia, stroke, Parkinson's disease, schizophrenia, addiction, anxiety and stress disorders.", "": "" }, { "Text": "1.41 \"First Commercial Sale\" means, with respect to a Licensed Product in the Field in a country in the Territory, the first sale to a Third Party for monetary value for use or consumption by the general public of such Licensed Product in such country after the applicable Regulatory Authority has approved the Drug Approval Application for such Licensed Product in such country. Sales prior to the approval of the applicable Drug Approval Application, such as so-called \"treatment IND sales\", \"named patient sales\" and \"compassionate use sales\", shall not constitute a First Commercial Sale.", "": "" }, { "Text": "1.42 \"Force Majeure Event\" has the meaning set forth in Section 11.1.", "": "" }, { "Text": "1.43 \"GAAP\" means United States generally accepted accounting principles, consistently applied.", "": "" }, { "Text": "1.44 \"Good Reason\" means a clinical hold being placed on a Licensed Product, a delay in response from a Regulatory Authority, or a material drug manufacturing or supply chain problem that would be reasonably expected to impede or significantly delay a Licensed Product advancing through Development or Commercialization; provided, that if a Good Reason is invoked by Licensee as a reason to cease Development or Commercialization, then Licensee shall use Commercially Reasonable Efforts to resolve the problem(s) that is the basis of such Good Reason as soon as is practicable.", "": "" }, { "Text": "1.45 \"Hatch-Waxman Act\" means the Drug Price Competition and Patent Term Restoration Act of 1984, as amended.", "": "" }, { "Text": "1.46 \"IND\" means an investigational new drug application filed with the FDA for authorization to commence Clinical Trials in the United States (including all additions, supplements, extensions and modifications thereto), or any corresponding foreign application in the Territory.", "": "" }, { "Text": "1.47 \"Indemnification Claim Notice\" has the meaning set forth in Section 9.3.", "": "" }, { "Text": "1.48 \"Indemnified Party\" has the meaning set forth in Section 9.3.", "": "" }, { "Text": "1.49 \"Indemnifying Party\" means the Party from whom indemnification is sought pursuant to Section 9.1 or Section 9.2.", "": "" }, { "Text": "1.50 \"Information\" means all technical, scientific and other know-how and information, trade secrets, knowledge, technology, means, methods, processes, practices, formulas, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings, assembly procedures, computer programs, apparatuses, specifications, data, results and other material, including pre-clinical trial results and data and results with respect to Clinical Trials, Manufacturing procedures, test procedures, and purification and isolation techniques, (whether or not confidential, proprietary, patented or patentable) in written, electronic or any other form now known or hereafter developed, and all other discoveries, developments, inventions (whether or not confidential, proprietary, patented or patentable), and tangible embodiments of any of the foregoing.", "": "" }, { "Text": "1.51 \"Infringement\" has the meaning set forth in Section 6.3.1.", "": "" }, { "Text": "1.52 \"Infringement Notice\" has the meaning set forth in Section 6.3.1.", "": "" }, { "Text": "1.53 \"Initial Notice\" has the meaning set forth in Section 3.7.1.", "": "" }, { "Text": "1.54 \"Initial Period\" has the meaning set forth in Section 3.7.3.", "": "" }, { "Text": "1.55 \"Initiate\" means, with respect to a Clinical Trial, the first dosing of the first patient in such Clinical Trial.", "": "" }, { "Text": "1.56 \"Invoiced Sales\" has the meaning set forth in the definition of \"Net Sales\".", "": "" }, { "Text": "1.57 \"Joint Intellectual Property Rights\" has the meaning set forth in Section 6.1.2.", "": "" }, { "Text": "1.58 \"Joint Know-How\" has the meaning set forth in Section 6.1.2.", "": "" }, { "Text": "1.59 \"Joint Patents\" has the meaning set forth in Section 6.1.2.", "": "" }, { "Text": "1.60 \"Knowledge\" means (a) with respect to Allergan and its Affiliates, the actual knowledge of Allergan's and its Affiliates' employees listed on Schedule 1.60 without any duty to conduct any investigation, and (b) with respect to Licensee, its Sublicensees and its and their Affiliates, the actual knowledge of Licensee's, its Sublicensees' and its and their Affiliates' respective Chief Executive Officer, Chief Financial Officer and Chief Technology Officer (or equivalent officers) and its and their counsel (both inside and outside), in each case after due inquiry.", "": "" }, { "Text": "1.61 \"LIBOR\" means the London Interbank Offered Rate for deposits in Dollars having a maturity of one month administered by the ICE Benchmark Administration, as adjusted from time to time on the first London business day of each month.", "": "" }, { "Text": "1.62 \"Licensed Compound\" means (2R,3S)-2-amino-3-hydroxy-3-(pyridin-4-yl)-1-(pyrrolidin-1-yl)propan-1-one (AGN-209323), including any metabolites, polymorphs, salts, esters, free acid forms, free base forms, pro drug forms, stereoisomers, racemates or optically active forms thereof.", "": "" }, { "Text": "1.63 \"Licensed Know-How\" means all Information developed by Allergan or any of its Affiliates or licensees as of the Original Effective Date that is Controlled by Allergan or its Affiliates, is not generally known and is necessary or reasonably useful for the Exploitation of the Licensed Products in the Field in the Territory, but excluding, in each case, any Joint Know-How and any Information to the extent claimed or covered by published Licensed Patents or Joint Patents. Licensed Know-How shall be limited to Information relating to the Licensed Products in the Field in such form as such Licensed Products exist as of the Effective Date and shall not include any Information relating to any modification or enhancement included in, made to or used with, or any active ingredient combined in or used with, such Licensed Products (e.g. any formulation or delivery system).", "": "" }, { "Text": "1.64 \"Licensed Patents\" means (i) the national, regional and international patents and patent applications, including provisional patent applications, as set forth on Schedule 1.64, (ii) all patent applications that claim priority to any patent or patent applications in clause (i), including divisionals, continuations, continuations-in-part, provisionals, converted provisionals, and continued prosecution applications, in each case, to the extent claiming the Licensed Compound or its manufacture or use, (iii) any and all patents that have issued or in the future issue from any of foregoing patent applications in clause (i) or clause (ii), including utility models, petty patents and design patents and certificates of invention, and (iv) any and all extensions or restorations by existing or future extension or restoration mechanisms, including revalidations, reissues, re-examinations and extensions (including any supplementary protection certificates and the like) of any of the foregoing patents or patent applications in clause (i), clause (ii), or clause (iii). Licensed Patents shall be limited to Patents to the extent that they claim the Licensed Products in the Field in such form as such Licensed Products exist as of the Original Effective Date and shall not include any claims relating to any modification or enhancement included in, made to or used with, or any active ingredient combined in or used with, such Licensed Products (e.g. any formulation or delivery system).", "": "" }, { "Text": "1.65 \"Licensed Product\" means any pharmaceutical product containing the Licensed Compound, alone or in combination with one or more other active ingredients.", "": "" }, { "Text": "1.66 \"Licensed Product Agreement\" means, with respect to a Licensed Product, any agreement entered into by and between Licensee or any of its Sublicensees or its or their respective Affiliates, on the one hand, and one or more Third Parties (including any agreements with Sublicensees), on the other hand, during the Term that relates to the Exploitation of such Licensed Product in the Field in the Territory, including (a) any agreement pursuant to which Licensee, its Sublicensees or its or their respective Affiliates receives or grants any license or other rights to Exploit such Licensed Product, (b) supply agreements pursuant to which Licensee, its Sublicensees or its or their respective Affiliates obtain or will obtain quantities of such Licensed Product, (c) clinical trial agreements covering Clinical Trials, (d) contract research organization agreements and (e) service agreements.", "": "" }, { "Text": "1.67 \"Licensed Technology\" means the Licensed Patents and the Licensed Know-How.", "": "" }, { "Text": "1.68 \"Licensee\" has the meaning set forth in the preamble hereto.", "": "" }, { "Text": "1.69 \"Licensee Indemnitees\" has the meaning set forth in Section 9.2.", "": "" }, { "Text": "1.70 \"Licensee Know-How\" means all Information and inventions conceived, discovered, developed, made, acquired or otherwise Controlled, or used, by Licensee, its Sublicensees, or any of its or their respective Affiliates under or in connection with (a) this Agreement or (b) the Exploitation of a Licensed Product, in either case ((a) and (b)) that is not generally known, but excluding any Joint Know-How and any Information to the extent covered or claimed by published Licensee Patents or Joint Patents.", "": "" }, { "Text": "1.71 \"Licensee Patents\" means all of the Patents Controlled by Licensee, its Sublicensees, or any of its or their respective Affiliates as of the Effective Date or during the Term that claim any Licensee Know-How, but excluding any Joint Patents.", "": "" }, { "Text": "1.72 \"Losses\" has the meaning set forth in Section 9.1.", "": "" }, { "Text": "1.73 \"MAA\" has the meaning set forth in the definition of \"Drug Approval Application.", "": "" }, { "Text": "1.74 \"Manufacture\" and \"Manufacturing\" means, with respect to a Licensed Product, all activities related to the production, manufacture, processing, filling, finishing, packaging, labeling, shipping, holding, Manufacture Process Development, stability testing, quality assurance or quality control of such Licensed Product or any intermediate thereof.", "": "" }, { "Text": "1.75 \"Manufacture Process Development\" means the process development, process qualification and validation and scale-up of the process to manufacture a Licensed Product and analytic development and product characterization with respect thereto.", "": "" }, { "Text": "1.76 \"Monetization\" means the monetization of all or a portion of Allergan's rights to receive royalties and other related payments under this Agreement, including by means of a direct sale (through an auction process or otherwise) or a financing (through a borrowing of loans, an offering of securities or otherwise).", "": "" }, { "Text": "1.77 \"NDA\" has the meaning set forth in the definition of \"Drug Approval Application.", "": "" }, { "Text": "1.78 \"Negotiation Notice\" has the meaning set forth in Section 3.7.3.", "": "" }, { "Text": "1.79 \"Negotiation Period\" has the meaning set forth in Section 3.7.3.", "": "" }, { "Text": "1.80 \"Net Sales\" means, for any period, the gross amount invoiced for sale or other disposition of Licensed Products by Licensee, its Sublicensees or any of its or their respective Affiliates to Third Party end users, Distributors or wholesalers (for the purposes of commercial distribution) (the \"Invoiced Sales\"), less the following deductions accounted for in accordance with GAAP, to the extent applicable:", "": "" }, { "Text": "(a) sales returns and allowances actually paid, granted or accrued on Licensed Products, including trade quantity, prompt pay and cash discounts and any other adjustments, including those granted on account of price adjustments or billing errors;", "": "" }, { "Text": "(b) credits or allowances given or made for rejection, recall, return or wastage replacement of Licensed Products or for rebates or retroactive price reductions;", "": "" }, { "Text": "(c) price reductions, rebates and chargeback payments granted to managed health care organizations, pharmacy benefit managers (or equivalents thereof), national, state/provincial, local, and other governments, their agencies and purchasers and reimbursers, or to trade customers (including Medicare, Medicaid, managed care and similar types of rebates and chargebacks);", "": "" }, { "Text": "(d) any administration fees or other fees for services provided by wholesalers, distributors (other than Distributors), warehousing chains and other Third Parties related to the distribution of Licensed Products;", "": "" }, { "Text": "(e) if included in the aggregate gross invoice price of Licensed Products, taxes, duties or other governmental charges (including any tax such as VAT or similar tax, other than any taxes based on income) relating to the sale of Licensed Products, as adjusted for rebates and refunds;", "": "" }, { "Text": "(f) the portion of administrative fees paid during such time period to group purchasing organizations or pharmaceutical benefit managers relating to Licensed Products;", "": "" }, { "Text": "(g) any invoiced amounts for Licensed Products that are not collected by Licensee, its Sublicensees or its or their respective Affiliates, including bad debts (provided that any such amounts subsequently collected will be included in Net Sales for the period in which they are collected);", "": "" }, { "Text": "(h) that portion of the annual fee on prescription drug manufacturers imposed by the U.S. Patient Protection and Affordable Care Act that any of Licensee, its Sublicensees or its or their respective Affiliates allocate to sales of Licensed Products in accordance with their standard policies and procedures;", "": "" }, { "Text": "(i) any consideration actually paid or payable for, or reasonably allocable to, any delivery system related to the invoiced sale of Licensed Products; and", "": "" }, { "Text": "(j) any other similar and customary deductions that are consistent with GAAP;", "": "" }, { "Text": "to the extent such deductions: (i) are applicable and in accordance with standard allocation procedures, (ii) have not already been deducted or excluded, and (iii) are incurred in the ordinary course of business in type and amount consistent with good industry practice. Any of the deductions listed above that involves a payment by Licensee, its Sublicensees or any of its or their respective Affiliates shall be taken as a deduction in the Calendar Quarter in which the payment is accrued by such entity in accordance with GAAP.", "": "" }, { "Text": "Net Sales shall not include transfers of a Licensed Product without consideration or for nominal consideration for use in any research purpose, Clinical Trial, or for any bona fide charitable, compassionate use or indigent patient program purpose or as a sample. For the avoidance of doubt, in the case of any transfer of a Licensed Product between or among Licensee, its Sublicensees or any of its or their respective Affiliates for resale, Net Sales shall be determined based on the sale made by such Person to a Third Party (other than Licensee, its Sublicensees and its and their respective Affiliates). In the case of any sale for value, such as barter or counter-trade, of a Licensed Product, or part thereof, other than in an arm's length transaction exclusively for cash, Net Sales shall be deemed to be the Net Sales at which substantially similar quantities of such Licensed Product are sold for cash in an arm's length transaction in the relevant country. Notwithstanding anything to contrary contained herein, sales of a Licensed Product (x) that uses such Licensed Product as the reference-listed drug in an abbreviated new drug application, biologics license application or in an application under 21 U.S.C. § 355(b)(2) or other similar Applicable Law by a Third Party, (y) by a Third Party that has received a license from Licensee, its Sublicensees or its or their respective Affiliates in settlement of any dispute or pursuant to any judgment or (z) by a Third Party pursuant to a compulsory license, in each case ((x) - (z)), shall not be included in Net Sales.", "": "" }, { "Text": "In the case of pharmacy incentive programs, hospital performance incentive programs, chargebacks, disease management programs, similar programs or discounts on portfolio product offerings that include a Licensed Product, all rebates, discounts and other forms of reimbursements shall be allocated among products fairly and equitably so that such Licensed Product does not bear a disproportionate portion of such allocation; provided, that any such allocation shall be done in accordance with Applicable Law, including any price reporting laws, rules and regulations.", "": "" }, { "Text": "1.81 \"Non-Controlling Party\" has the meaning set forth in Section 6.4.1.", "": "" }, { "Text": "1.82 \"Non-Prosecuting Party\" has the meaning set forth in Section 6.2.1.", "": "" }, { "Text": "1.83 \"Offer Notice\" has the meaning set forth in Section 3.7.2.", "": "" }, { "Text": "1.84 \"Parent\" means Forsight Labs, LLC, a California limited liability company.", "": "" }, { "Text": "1.85 \"Party\" and \"Parties\" each has the meaning set forth in the preamble hereto.", "": "" }, { "Text": "1.86 \"Patent Challenge\" has the meaning set forth in Section 10.3.2.", "": "" }, { "Text": "1.87 \"Patents\" means (a) all national, regional and international patents and patent applications, including provisional patent applications, (b) all patent applications that claim, directly or indirectly, priority to any patent or patent applications in clause (a), including divisionals, continuations, continuations-in-part, provisionals, converted provisionals, continued prosecution applications and requests for continued examination, (c) any and all patents that have issued or in the future issue from any of foregoing patent applications in clause (a) or clause (b), including utility models, petty patents and design patents and certificates of invention, and (d) any and all extensions or restorations by existing or future extension or restoration mechanisms, including revalidations, reissues, re-examinations or any other post-grant proceeding, extensions (including any supplementary protection certificates and the like) of any of the foregoing patents or patent applications in clause (a), clause (b) or clause (c).", "": "" }, { "Text": "1.88 \"Payee\" has the meaning set forth in Section 5.5.", "": "" }, { "Text": "1.89 \"Payments\" has the meaning set forth in Section 5.5.", "": "" }, { "Text": "1.90 \"Payor\" has the meaning set forth in Section 5.5.", "": "" }, { "Text": "1.91 \"Person\" means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, unincorporated association, joint venture or other similar entity or organization, including a government or political subdivision, department or agency of a government.", "": "" }, { "Text": "1.92 \"Phase 1 Clinical Trial\" means a Clinical Trial the principal purpose of which is a preliminary determination of safety in healthy individuals or patients or that would otherwise satisfy the requirements of 21 C.F.R. §312.21(a), as amended.", "": "" }, { "Text": "1.93 \"Phase 2 Clinical Trial\" means a Clinical Trial, the principal purpose of which is a determination of safety and efficacy of a product in the target patient population or a similar Clinical Trial prescribed by the Regulatory Authorities, from time to time, pursuant to Applicable Law or otherwise, including the trials referred to in 21 C.F.R. §312.21(b), as amended.", "": "" }, { "Text": "1.94 \"Phase 2(a) Clinical Trial\" means a Phase 2 Clinical Trial that is solely intended to make a preliminary determination of the effectiveness of a product for a particular indication or indications in patients with the disease or indication under study.", "": "" }, { "Text": "1.95 \"Phase 2(b) Clinical Trial\" means a Phase 2 Clinical Trial conducted after a Phase 2(a) Clinical Trial and that is intended to make a further determination of the effectiveness and safety of a product for a particular indication or indications in patients with the disease or indication under study, at the intended clinical dose or doses or range of doses, on a sufficient number of subjects and for a sufficient duration to confirm the optimal manner of use of such compound or product (dose and dose regimen) prior to initiation of one or more pivotal Phase 3 Clinical Trials or filing for a Regulatory Approval without the initiation of such pivotal Phase 3 Clinical Trials.", "": "" }, { "Text": "1.96 \"Phase 3 Clinical Trial\" means a Clinical Trial on a sufficient number of subjects that is designed to establish that a Licensed Product is safe and efficacious for its intended use and to determine warnings, precautions and adverse reactions that are associated with such Licensed Product in the dosage range to be prescribed, which Clinical Trial is intended to support Regulatory Approval of such Licensed Product, including all tests and studies that are required by the FDA from time to time, pursuant to Applicable Law or otherwise.", "": "" }, { "Text": "1.97 \"Prior CDA\" has the meaning set forth in Section 7.1.", "": "" }, { "Text": "1.98 \"Product Trademarks\" means the Trademark(s) to be used by Licensee, its Sublicensees or its or their respective Affiliates for the Commercialization of the Licensed Products in the Field in the Territory and any registrations thereof or any pending applications relating thereto in the Territory (excluding, in any event, any Trademarks that include any corporate name or logo of the Parties or their Affiliates); provided that Product Trademarks shall exclude any of Licensee's Trademarks that are not specific to the Licensed Products.", "": "" }, { "Text": "1.99 \"Prosecuting Party\" has the meaning set forth in Section 6.2.1.", "": "" }, { "Text": "1.100 \"Qualified Financing\" means, with respect to any Person, the issuance of debt or equity securities by such Person, the proceeds of which are invested in the business of such Person or its subsidiaries.", "": "" }, { "Text": "1.101 \"Qualifying Sublicense Payments\" means, with respect to a Licensed Product in a particular country in the Territory for a particular period of time, all payments, directly or indirectly, made by or on behalf of a Sublicensee or Distributor to Licensee, the direct or indirect holders of equity interests in Licensee, or their respective Affiliates (collectively, the \"Payment Recipients\") relating to, or resulting from, in either case, directly or indirectly, any transaction, series of transactions, or other arrangement in which such Sublicensee or Distributor obtains from Licensee or any of its Affiliates a license (or sublicense) in respect of, or other right to Develop or Commercialize, the Licensed Patents, the Licensed Know-How, the Licensed Compound, or a Licensed Product (or any option or other right to obtain a license in respect of the Licensed Patents, the Licensed Know-How, the Licensed Compound, or a Licensed Product) (each, a \"Sublicense Grant\"), including (i) all upfront and other payments payable to the Payment Recipients upon execution of such transaction(s) or arrangement(s) with such Sublicensee or Distributor in respect of Licensee's rights hereunder; (ii) all development, regulatory, commercialization or other milestone payments for milestones under any such transaction(s) or arrangement(s); (iii) all license maintenance fees under any such transaction(s) or arrangements(s); (iv) all payments to the Payment Recipients for the supply of Licensed Products in excess of the Payment Recipients' actual cost of goods sold to produce or Manufacture such Licensed Products supplied to such Sublicensee or Distributor; (v) all payments to the Payment Recipients under any such transaction(s) or arrangement(s) for the reimbursement of research and development costs incurred by the Payment Recipients in excess of their actual cost to perform such activities; (vi) the fair market value of any debt or equity securities issued in respect of any such transaction(s) or arrangement(s) to the Payment Recipients that exceeds any amount paid by the Payment Recipients for such securities; (vii) the amount by which any amount paid by such Sublicensee or Distributor to the Payment Recipients for debt or equity securities issued to such Sublicensee in respect of any such transaction(s) or arrangement(s) exceeds the fair market value of such securities; and (viii) the fair market value of any other form of consideration paid to the Payment Recipients by such Sublicensee or Distributor in respect of any such transaction(s) or arrangement(s), excluding any royalty or other similar payment based on a percentage of such Sublicensee's or Distributor's Net Sales. For clarity, to the extent a payment is made to Allergan pursuant to Section 5.3.2 for a Qualifying Sublicense Payment, the subsequent distribution by Licensee of all or a portion of such Qualifying Sublicense Payment to its direct or indirect holders of equity interests would not constitute a second Qualifying Sublicense Payment for purposes of Section 5.3.2.", "": "" }, { "Text": "1.102 \"Receiving Party\" has the meaning set forth in Section 7.1.", "": "" }, { "Text": "1.103 \"Regulatory Approval\" means, with respect to a Licensed Product in a country in the Territory, any and all approvals (including Drug Approval Applications), licenses, registrations or authorizations of any Regulatory Authority necessary to commercially distribute, sell or market such Licensed Product in such country, including, where applicable, (a) pricing or reimbursement approval in such country, (b) pre- and post-approval marketing authorizations (including any prerequisite Manufacturing approval or authorization related thereto) and (c) labeling approval.", "": "" }, { "Text": "1.104 \"Regulatory Authority\" means any applicable supra-national, federal, national, regional, state, provincial or local regulatory agencies, departments, bureaus, commissions, councils or other government entities regulating or otherwise exercising authority with respect to the Exploitation of the Licensed Compound or a Licensed Product in the Territory.", "": "" }, { "Text": "1.105 \"Regulatory Documentation\" means all (a) applications (including all INDs and Drug Approval Applications), registrations, licenses, authorizations and approvals (including all Regulatory Approvals) and (b) correspondence and reports submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority) and all supporting documents with respect thereto, including all regulatory drug lists, advertising and promotion documents, adverse event files and complaint files, in each case ((a) and (b)), relating to a Licensed Product.", "": "" }, { "Text": "1.106 \"Regulatory Exclusivity Period\" means, with respect to each Licensed Product in any country in the Territory, a period of exclusivity (other than Patent exclusivity) granted or afforded by Applicable Law or by a Regulatory Authority in such country that confers exclusive marketing rights with respect to such Licensed Product in such country, such as new chemical entity exclusivity, new use or indication exclusivity, new formulation exclusivity, orphan drug exclusivity, non-patent related pediatric exclusivity or any other applicable marketing or data exclusivity, including any such periods listed in the FDA's Orange Book or any such periods under national implementations in the EU of Article 10 of Directive 2001/83/ED, Article 14(11) of Parliament and Council Regulation (EC) No. 726/2004, Parliament and Council Regulation (ED) No. 141/2000 on orphan medicines, Parliament and Council Regulation (ED) No. 1901/2006 on medicinal products for pediatric use and all international equivalents of any of the foregoing.", "": "" }, { "Text": "1.107 \"Relevant Entity\" means Licensee, any Subject Affiliate, any Controlling Affiliate or any Sublicensee.", "": "" }, { "Text": "1.108 \"Royalty Term\" means, with respect to each Licensed Product and each country in the Territory, the period beginning on the date of the First Commercial Sale of such Licensed Product in such country, and ending on the latest to occur of (a) the expiration of the last-to-expire Licensed Patent that includes a Valid Claim in such country or in the country in which such Licensed Product (or any component thereof) is Manufactured, (b) the fifteenth anniversary of the First Commercial Sale of such Licensed Product in such country and (c) the expiration of the Regulatory Exclusivity Period in such country for such Licensed Product.", "": "" }, { "Text": "1.109 \"Subject Affiliate\" means any Affiliate of Licensee that (a) has any right, title or interest in or to any Licensed Patent, Licensed Know-How, Joint Patent or Joint Know-How or (b) is otherwise engaged in the Development, Manufacture, Commercialization or any regulatory activities with respect to the Licensed Compound or a Licensed Product.", "": "" }, { "Text": "1.110 \"Sublicense Grant\" has the meaning set forth in the definition of \"Qualifying Sublicense Payments\".", "": "" }, { "Text": "1.111 \"Sublicensee\" means a Person, other than an Affiliate of Licensee, that is granted a sublicense under the grant in Section 2.1 as provided in Section 2.4.", "": "" }, { "Text": "1.112 \"Term\" has the meaning set forth in Section 10.1.", "": "" }, { "Text": "1.113 \"Termination Notice Period\" has the meaning set forth in Section 10.2.", "": "" }, { "Text": "1.114 \"Territory\" means the entire world.", "": "" }, { "Text": "1.115 \"Third Party\" means any Person other than Allergan, Licensee and their respective Affiliates.", "": "" }, { "Text": "1.116 \"Third Party Claims\" has the meaning set forth in Section 9.1.", "": "" }, { "Text": "1.117 \"Trademark\" means any word, name, symbol, color, designation or device or any combination thereof that functions as a source identifier, including any trademark, trade dress, brand mark, service mark, trade name, brand name, logo or business symbol, whether or not registered.", "": "" }, { "Text": "1.118 \"Transferred Compounds\" has the meaning set forth in Section 2.7.2.", "": "" }, { "Text": "1.119 \"Valid Claim\" means, with respect to a particular country, (a) any claim of an issued and unexpired Patent in such country that (i) has not been held permanently revoked, unenforceable or invalid by a decision of a court or governmental agency of competent jurisdiction that is unappealable or unappealed within the time allowed for appeal and (ii) has not been abandoned, disclaimed, denied or admitted to be invalid or unenforceable through reissue or disclaimer or otherwise in such country or (b) any claim of a pending Patent application that has not been abandoned or finally disallowed without the possibility of appeal or re-filing of the application.", "": "" }, { "Text": "1.120 \"VAT\" has the meaning set forth in Section 5.6.", "": "" }, { "Text": "1.121 \"Withholding Taxes\" has the meaning set forth in Section 5.5.", "": "" }, { "Text": "ARTICLE 2 GRANT OF RIGHTS", "": "" }, { "Text": "2.1 Grants to Licensee. Subject to Section 2.3 and the other terms and conditions of this Agreement, Allergan hereby grants to Licensee:", "": "" }, { "Text": "2.1.1 an exclusive (including with regard to Allergan and its Affiliates) license, with the right to grant sublicenses in accordance with Section 2.4, under the Licensed Patents and Allergan's interest in the Joint Patents and a non-exclusive license, with the right to grant sublicenses in accordance with Section 2.4, under the Licensed Know-How and Allergan's interest in the Joint Know-How, in each case to Exploit the Licensed Compound and the Licensed Products in the Field in the Territory; and", "": "" }, { "Text": "2.1.2 an exclusive (including with regard to Allergan and its Affiliates) right of reference, with the right to grant further rights of reference in accordance with Section 2.4, under (a) any Allergan Regulatory Documentation that cannot be assigned to Licensee pursuant to Section 3.2 any Regulatory Documentation Controlled by Allergan or any of its Affiliates after the Effective Date during the Term that is necessary or reasonably useful for the Exploitation of the Licensed Compound or a Licensed Product in the Field in the Territory, in each case ((a) and (b)), to Exploit the Licensed Compound and the Licensed Products in the Field in the Territory.", "": "" }, { "Text": "2.2 Intentionally Omitted.", "": "" }, { "Text": "2.3 Retention of Rights; Passive Sales.", "": "" }, { "Text": "2.3.1 Allergan Retained Rights. Notwithstanding anything to the contrary in this Agreement, Allergan retains, on behalf of itself and its Affiliates:", "": "" }, { "Text": "(a) non-exclusive rights in and to the Licensed Patents, the Joint Patents, the Licensed Know-How, the Joint Know-How and Allergan Regulatory Documentation to conduct research, including preclinical testing with respect to the Licensed Compound and Licensed Products in the Field in the Territory, and to Manufacture the Licensed Compound and Licensed Products, for use in the performance of such research, provided that (i) such research shall be conducted solely by or on behalf of Allergan or its Affiliates for its or their internal research purposes, and (ii) Allergan shall promptly inform Licensee of the results of all such research, which shall become Licensed Patents or Licensed Know-How, as applicable, pursuant to Section 1.64 and Section 1.63 respectively and licensed to Licensee hereunder; and", "": "" }, { "Text": "(b) all right, title and interest in and to the Licensed Patents, the Licensed Know-How, Allergan's interest in the Joint Patents and the Joint Know-How, and any Allergan Regulatory Documentation that is not assigned pursuant to Section 3.2, in each case, to develop and obtain and maintain regulatory approvals for and to manufacture, commercialize and otherwise exploit any compound or product other than the Licensed Compound or Licensed Products in all fields (including the Field) anywhere in the Territory.", "": "" }, { "Text": "2.4 Sublicenses. Licensee shall have the right to grant sublicenses and further rights of reference, under the licenses and rights of reference granted in Section 2.1, to its Affiliates and any Third Party through multiple tiers; provided that Licensee shall provide written notification to Allergan promptly following the execution of each sublicense agreement with a Third Party Sublicensee. Licensee shall (A) remain jointly and severally liable for the performance or non-performance of any such Sublicensee and the grant of any such sublicense shall not relieve Licensee of its obligations under this Agreement, and (B) require each Sublicensee to agree in writing to be bound by the applicable terms and conditions of this Agreement, including Section 3.5, Section 4.8, Section 5.8, Section 5.9, ARTICLE 6, ARTICLE 7 and Section 10.9. Licensee shall provide Allergan with a copy of any sublicense agreement executed by Licensee within 14 days after its execution; provided that the terms of any such sublicense agreement to the extent not pertinent to an understanding of a Party's obligations or benefits under this Agreement may be redacted. Any such sublicenses shall be consistent with, and subordinate to, the terms and conditions of this Agreement.", "": "" }, { "Text": "2.5 No Implied Rights. For the avoidance of doubt, Licensee, its Sublicensees and its and their respective Affiliates shall have no right, express or implied, with respect to the Licensed Patents, the Licensed Know-How, or the Allergan Regulatory Documentation, except as expressly provided in Section 2.1 and Section 3.2.", "": "" }, { "Text": "2.6 Intentionally Omitted.", "": "" }, { "Text": "2.7 Technology Transfer and Cooperation.", "": "" }, { "Text": "2.7.1 Promptly and in any event within 45 days after the Original Effective Date, Allergan shall disclose and make available to Licensee each of the items set forth on Schedule 2.7.1, provided in the event Allergan fails to provide such items within such 45-day period, then the period of time within which Licensee is to perform each of the diligence milestones set forth in Section 3.1.4(b) will be automatically extended for the same number of days that elapse between the end of such 45-day period and Allergan's provision of all such items.", "": "" }, { "Text": "2.7.2 Allergan hereby assigns to Licensee all of its right, title and interest in and to the quantities of the Licensed Compound, labeled samples or synthetic intermediates set forth on Schedule 2.7.2 (the \"Transferred Compounds\"). Allergan shall deliver such Transferred Compounds to Licensee promptly, and in any event within 45 days, after the Original Effective Date. The Parties agree that: (a) such Transferred Compounds shall be used solely for the Development of Licensed Products pursuant to this Agreement; and (b) all such Transferred Compounds shall be provided without any warranties, express or implied.", "": "" }, { "Text": "2.7.3 In no event shall Allergan's cumulative obligations under this Section 2.7 exceed 30 hours in the aggregate or extend beyond 45 days after the Original Effective Date without prior written consent from Allergan.", "": "" }, { "Text": "2.7.4 Licensee acknowledges that Allergan satisfied its transfer obligations under this Section 2.7 prior to the Effective Date.", "": "" }, { "Text": "2.8 Intentionally Omitted.", "": "" }, { "Text": "2.9 In-License Agreements. The licenses granted by Allergan in Section 2.1 include sublicenses under the applicable license rights granted to Allergan by Third Parties under the Allergan Agreements, subject to this Section 2.9. Any sublicense with respect to Information or intellectual property rights of a Third Party hereunder and any right of Licensee (if any) to grant a further sublicense thereunder, shall be subject and subordinate to the terms and conditions of the applicable Allergan Agreement under which such sublicense is granted and shall be effective solely to the extent permitted under the terms of such agreement. Without limitation of the foregoing, in the event and to the extent that any Allergan Agreement requires that particular terms or conditions of such Allergan Agreement be contained or incorporated in any agreement granting a sublicense thereunder, such terms and conditions are hereby deemed to be incorporated herein by reference and made applicable to the sublicense granted herein under such Allergan Agreement. Allergan represents and warrants that it has provided Licensee with current, complete and accurate copies of all Allergan Agreements.", "": "" }, { "Text": "2.10 Covenant Not to Sue. Subject to the terms of this Agreement, Allergan, on behalf of itself and its Affiliates existing as of the Effective Date, covenants not to sue, not to assign to any other entity a right to sue, and not to authorize any other entity to sue, Licensee or any of its Sublicensees for any claim, counterclaim, demand, cause of action, suit, damages or equitable relief under any Patents Controlled by Allergan during the Term with respect to the Exploitation by or on behalf of Licensee or any of its Sublicensees of the Licensed Products in the Field in such form as the Licensed Products exist as of the Effective Date. For the avoidance of doubt, this covenant shall not apply to any modification or enhancement included in, made to or used with, or any active ingredient combined in or used with, any Licensed Products (e.g. any formulation or delivery system).", "": "" }, { "Text": "ARTICLE 3 DEVELOPMENT AND REGULATORY", "": "" }, { "Text": "3.1 Development.", "": "" }, { "Text": "3.1.1 In General. Subject to Section 3.1.2, Licensee shall have the right and the obligation to Develop the Licensed Products in the Field in the Territory at its own cost and expense.", "": "" }, { "Text": "3.1.2 Diligence.", "": "" }, { "Text": "(a) Licensee shall use Commercially Reasonable Efforts to Develop, and obtain and maintain Regulatory Approvals for, the Licensed Products in the Field in the United States.", "": "" }, { "Text": "(b) Without limitation of Section 3.1.2(a), Licensee shall fulfill the following Development obligations, in each case, within the time period set forth below with respect to such obligation:", "": "" }, { "Text": "(i) Licensee shall Initiate a Clinical Trial for a Licensed Product by the second anniversary of the Effective Date; and", "": "" }, { "Text": "(ii) Licensee is permitted to obtain one (and only one) 12-month extension of the above diligence milestone in (i) by payment to Allergan of $100,000 for such extension, which shall be made before the due date for the applicable milestone.", "": "" }, { "Text": "3.2 Regulatory Matters.", "": "" }, { "Text": "Regulatory Responsibilities. As between the Parties, Licensee shall have the sole right and responsibility for preparing, obtaining and maintaining Drug Approval Applications and any other Regulatory Approvals and other submissions, and for conducting communications with the Regulatory Authorities, for the Licensed Products in the Field in the Territory. All Regulatory Approvals, other than any Regulatory Approvals included in any Allergan Regulatory Documentation that is not assigned hereunder, relating to the Licensed Products with respect to the Field in the Territory shall be owned by, and shall be the sole property and held in the name of, Licensee or its permitted Sublicensee. Allergan hereby assigns to Licensee all of Allergan's right, title, and interest in and to all Regulatory Documentation Controlled by Allergan and held in Allergan's name as of the Effective Date. Within 45 days of the Effective Date, Allergan shall submit to the FDA and other applicable Regulatory Authorities letters substantially in the form set forth on Schedule 3.2 and sufficient under Applicable Law to transfer such Regulatory Documentation to Licensee, and Licensee shall submit to the FDA and other applicable Regulatory Authorities letters substantially in the form set forth on Schedule 3.2 accepting such transfer. The Parties acknowledge that all relevant letters were submitted to the FDA and other applicable Regulatory Authorities in satisfaction of the obligations under this Section 3.2 prior to the Effective Date.", "": "" }, { "Text": "3.3 Reports. While Licensee is performing any Development activities, (a) Licensee shall provide Allergan with a detailed report once per Calendar Year describing (i) the Development activities it has performed, or caused to be performed, since the preceding report (or since the Effective Date with respect to the first report), including any filings, submissions, communications or meetings with any Regulatory Authorities, and (ii) its Development activities in process, including (x) the estimated timeline for the completion of such activities and (y) whether it plans to subcontract any such activities, and (b) promptly upon completion of each Clinical Trial with respect to a Licensed Product, Licensee shall promptly provide Allergan a copy of the final clinical study report with respect to such Clinical Trial. Licensee shall notify Allergan in writing in the event that it ceases Development activities. Licensee shall arrange for appropriate representatives of Licensee having reasonable knowledge of any of the matters set forth in each written report to meet with Allergan (at least once per calendar year in person at the offices of Allergan) no later than 30 days following the date of receipt by Allergan of such report for the purpose of providing Allergan with an opportunity to discuss such report and the matters required to be reported in such report as provided in this Section 3.3.", "": "" }, { "Text": "3.4 Records. Licensee shall, and shall cause its Sublicensees and its and their Affiliates to, maintain, in a good scientific manner, complete and accurate books and records pertaining to Development of Licensed Products hereunder, in sufficient detail to verify compliance with its obligations under this Agreement. Such books and records shall (a) be appropriate for patent and regulatory purposes, (b) be in compliance with Applicable Law, (c) properly reflect all work done and results achieved in the performance of its Development activities hereunder, (d) record only such activities and not include or be commingled with records of activities outside the scope of this Agreement and (e) be retained for at least three years after the expiration or termination of this Agreement in its entirety or for such longer period as may be required by Applicable Law. Allergan shall have the right, during normal business hours and upon reasonable notice, to inspect and copy all such books and records maintained pursuant to this Section 3.4; provided that Allergan shall maintain such records and information disclosed therein in confidence in accordance with ARTICLE 7.", "": "" }, { "Text": "3.5 Subcontracting; Licensed Product Agreements. Licensee may subcontract the exercise of its rights and the performance of its obligations under this ARTICLE 3; provided that Licensee shall oversee the performance by its subcontractors of the subcontracted activities and shall remain responsible for the performance of such activities in accordance with this Agreement. Licensee shall obtain Allergan's written consent prior to entering into any Licensed Product Agreement that would impose any obligation on Allergan, or limit in any material respect Allergan's rights under this Agreement, including with respect to the payments it would receive under this Agreement, with respect to any of its rights or obligations under Section 10.9. Any Licensed Product Agreement and any other agreement pursuant to which Licensee engages a subcontractor must (a) be consistent with this Agreement and (b) contain terms obligating the counterparty to such Licensed Product Agreement or such subcontractor to (i) comply with confidentiality provisions that are at least as restrictive as those set forth in ARTICLE 7; (ii) provide Allergan with substantially the same rights with respect to any Information, Patents and other intellectual property arising from the performance of the subcontracted obligation as Allergan would have under this Agreement if such Information, Patents or other intellectual property had arisen from the performance of such obligation by Licensee, including pursuant to Section 10.9; and (iii) subject to Section 5.9, permit Allergan rights of inspection, access and audit substantially similar to those provided to Allergan under this Agreement.", "": "" }, { "Text": "3.6 Compliance. Licensee shall perform or cause to be performed any and all of its Development activities under this Agreement in a good scientific manner and in compliance with all Applicable Law.", "": "" }, { "Text": "3.7 Right of First Negotiation. Licensee agrees to provide Allergan with a right of first negotiation under the following terms:", "": "" }, { "Text": "3.7.1 Licensee shall provide Allergan a copy of the topline report for any Phase 2(b) Clinical Trial hereunder for a Licensed Product (the \"Initial Notice\") within ten Business Days after database lock for such Clinical Trial.", "": "" }, { "Text": "3.7.2 If Licensee or an Affiliate thereof enters into discussions with a Third Party or otherwise receives a proposal for a Change of Control of Licensee, then Licensee will promptly provide Allergan with written notice of such discussions and, unless restricted by obligations of confidentiality, a summary of any key terms and conditions of any proposal from a Third Party (the \"Offer Notice\"). Licensee and its Affiliates shall not, enter into an agreement (whether written or oral) with any Third Party relating to a Change of Control unless such party complies in full with the terms of this Section 3.7.", "": "" }, { "Text": "3.7.3 At any time prior to thirty (30) days after the date of the Initial Notice or the Offer Notice (the \"Initial Period\"), Allergan may provide Licensee with written notice that Allergan wishes to negotiate in good faith with Licensee to acquire Licensee or Licensee's assets (the \"Negotiation Notice\"). If Allergan provides Licensee with the Negotiation Notice during the Initial Period, then the Parties shall negotiate exclusively in good faith the terms of such acquisition for a period of sixty (60) days (the \"Negotiation Period\"). During the Negotiation Period, Licensee shall cease all discussions and negotiations with Third Parties regarding a Change of Control of Licensee.", "": "" }, { "Text": "3.7.4 If Allergan fails to provide the Negotiation Notice during the Initial Period or the Parties fail to reach agreement within the applicable Negotiation Period for any reason, then Licensee shall be free to negotiate a Change of Control with any Third Party, provided that Licensee will not, for a period of six (6) months after termination of the Negotiation Period, offer to any Third Party terms and conditions for a Change of Control of Licensee, which, taken as a whole, are more favorable to such Third Party than those terms and conditions last offered in writing by Allergan to Licensee without first offering such terms to Allergan and providing Allergan with thirty (30) days to accept such terms.", "": "" }, { "Text": "3.7.5 For clarity, Allergan shall be entitled to provide one Negotiation Notice, even in the case where one or more Offer Notices were previously provided by Licensee to Allergan but no Change of Control of Licensee occurred. Notwithstanding anything to the contrary herein, however, Allergan's rights and Licensee's obligations under this Section 3.7 shall terminate upon a Change of Control of Licensee or upon first dosing of the first patient in the first Phase 3 Clinical Trial hereunder for a Licensed Product.", "": "" }, { "Text": "3.8 Global Safety Database. Licensee shall hold, and maintain (at Licensee's sole cost and expense) the global safety database for the Licensed Products in the Field in the Territory.", "": "" }, { "Text": "ARTICLE 4 COMMERCIALIZATION", "": "" }, { "Text": "4.1 In General. Subject to Section 4.3, Licensee shall have the right and the obligation to Commercialize the Licensed Products in the Field in the Territory at its own cost and expense in accordance with the Commercialization Plan.", "": "" }, { "Text": "4.2 Commercialization Plan. At least 90 days prior to the anticipated First Commercial Sale of the first Licensed Product in the Territory, Licensee shall prepare an initial Commercialization Plan and submit such Commercialization Plan to Allergan for its review and comment, and Licensee shall consider Allergan's comments in good faith. For each Calendar Year thereafter during the Term, Licensee shall prepare an update to the Commercialization Plan and submit such updated Commercialization Plan to Allergan for its review and comment, and Licensee shall consider Allergan's comments in good faith. Licensee shall manage the preparation of each such update so that it is submitted to Allergan for its review at least 90 days prior to the end of the then-current Calendar Year.", "": "" }, { "Text": "4.3 Diligence. Licensee shall use Commercially Reasonable Efforts to Commercialize the Licensed Products in the Field to maximize Net Sales in accordance with Applicable Law in the United States.", "": "" }, { "Text": "4.4 Compliance with Applicable Law. Licensee shall, and shall cause its Sublicensees and its and their respective Affiliates to, comply with all Applicable Law with respect to the Commercialization of the Licensed Products. Licensee shall, and shall cause its Sublicensees and its and their respective Affiliates to, avoid taking or failing to take any actions that Licensee knows or reasonably should know would jeopardize the goodwill or reputation of the Licensed Products.", "": "" }, { "Text": "4.5 Sales and Distribution. As between the Parties, Licensee shall be solely responsible for invoicing and booking sales, establishing all terms of sale (including pricing and discounts) and warehousing and distributing the Licensed Products in the Field in the Territory and shall perform all related services, in each case, in a manner consistent with the terms and conditions of this Agreement. As between the Parties, Licensee shall be solely responsible for handling all returns, recalls and withdrawals, order processing, invoicing and collection, distribution and inventory and receivables with respect to the Licensed Product in the Field in the Territory.", "": "" }, { "Text": "4.6 Product Trademarks. Licensee shall have the right to determine and own the Product Trademarks to be used with respect to the Exploitation of the Licensed Products in the Field in the Territory.", "": "" }, { "Text": "4.7 Manufacture and Supply. Licensee shall (a) be responsible for the Manufacture of each Licensed Product in sufficient quantities for the Exploitation of such Licensed Product in the Field in the Territory and (b) use Commercially Reasonable Efforts to assure an efficient and reliable supply of each Licensed Product conforming to the applicable specifications with respect thereto as necessary to Exploit and maintain Regulatory Approvals for such Licensed Product in the Field in the Territory, including developing commercially reasonable arrangements and strategies for back-up sources of supply of such Licensed Product that appropriately and reasonably minimize the risk of supply shortfalls and that take into account expected inventory levels and demand. In furtherance of the obligations set forth in the preceding sentence, Licensee shall either itself Manufacture and supply, or enter into one or more definitive Manufacturing and supply agreements with appropriate Third Parties, to Manufacture and supply clinical and commercial supplies of each Licensed Product as required for Licensee, its Sublicensees and its and their Affiliates' Development and Commercialization of the Licensed Products for the Field in the Territory. Licensee shall, and shall cause its Sublicensees and its and their Affiliates and any Third Party that Manufactures and supplies clinical or commercial supplies of any Licensed Product to, comply with all Applicable Law with respect to the Manufacture of the Licensed Products.", "": "" }, { "Text": "4.8 Subcontracting. Subject to the next sentence, Licensee may subcontract the Commercialization of the Licensed Products in the Field in the Territory; provided that (a) Licensee shall remain responsible for the performance of such activities in accordance with this Agreement and the Commercialization Plan and (b) any agreement pursuant to which Licensee engages a subcontractor must (i) be consistent in all material respects with this Agreement and (ii) contain terms obligating such subcontractor to: (A) comply with confidentiality provisions that are at least as restrictive as those set forth in ARTICLE 7; (B) provide Allergan with substantially the same rights with respect to any intellectual property arising from the performance of the subcontracted obligation as Allergan would have under this Agreement if such intellectual property had arisen from the performance of such obligation by Licensee, including pursuant to Section 10.9; and (C) subject to Section 5.9, permit Allergan rights of inspection, access and audit substantially similar to those provided to Allergan under this Agreement. Licensee shall obtain Allergan's written consent prior to entering into any subcontract with respect to the Commercialization of the Licensed Products that would impose any obligation on Allergan, or otherwise limit in any material respect Allergan's rights under this Agreement, including with respect to the payments it would receive under this Agreement or with respect to its rights and obligations under Section 10.9.2.", "": "" }, { "Text": "ARTICLE 5 PAYMENTS", "": "" }, { "Text": "5.1 Upfront and Allergan Agreements Payments.", "": "" }, { "Text": "5.1.1 No later than five Business Days after the Original Effective Date, Licensee shall pay Allergan a nonrefundable, noncreditable upfront amount equal to $500,000. Allergan acknowledges that Licensee made the foregoing payment prior to the Effective Date and no additional upfront payment is required in connection with the execution of this Agreement.", "": "" }, { "Text": "5.1.2 Licensee shall be responsible for any and all payments due or owed by Allergan or its Affiliates to Third Parties under the Allergan Agreements (including all royalty and milestone payments) as a result of any Development, Manufacture or Commercialization of the Licensed Compound or any Licensed Product by or on behalf of Licensee or any of its Sublicensees or its or their Affiliates and shall either, at Allergan's option, (a) promptly pay and report such amounts directly to the applicable Third Party in accordance with the applicable terms and conditions of the applicable Allergan Agreement or (b) if Allergan pays such Third Party, promptly after receiving Allergan's invoice therefor, reimburse Allergan for all such amounts paid by Allergan. Licensee's payment obligations under this Section 5.1.2 are in addition to all other payment obligations of Licensee hereunder.", "": "" }, { "Text": "5.2 Royalties.", "": "" }, { "Text": "5.2.1 Royalty Rates. During the Royalty Term, Licensee shall pay Allergan a royalty on Net Sales of all Licensed Products in the Territory (excluding Net Sales of each Licensed Product in any country in the Territory for which the Royalty Term for such Licensed Product and country has expired) in each Calendar Quarter (or partial Calendar Quarter) in an amount equal to 5% of such Net Sales.", "": "" }, { "Text": "5.2.2 Royalty Step-Down. For the purpose of determining the royalties payable pursuant to Section 5.2.1 solely from Net Sales in the United States, the Net Sales of a Licensed Product in the United States that occur after the expiration date of the last to expire of, or during any period in which there are no, Licensed Patents that include at least one Valid Claim in the United States or, if different, in any country in which such Licensed Product (or any component thereof) is Manufactured, shall be reduced by 40%.", "": "" }, { "Text": "5.2.3 Payment Dates and Reports. Royalty payments shall be made by Licensee within 60 days after the end of each Calendar Quarter commencing with the Calendar Quarter in which the first day of the first Royalty Term for the first Licensed Product occurs. Licensee shall also provide to Allergan, at the same time each such payment is made, a report showing: (a) the Net Sales of the Licensed Products by country in the Territory; (b) the basis for any deductions from Invoiced Sales to determine Net Sales; (c) the exchange rates used in calculating any of the foregoing; and (d) a calculation of the amount of royalty due to Allergan.", "": "" }, { "Text": "5.3 Sublicense Revenue.", "": "" }, { "Text": "5.3.1 Net Sales by Sublicensees. Any and all Net Sales by Sublicensees shall be included in the Net Sales calculations in Section 5.2.1 for purposes of determining the royalties owed by Licensee to Allergan thereunder.", "": "" }, { "Text": "5.3.2 Other Sublicense Revenue. Licensee shall pay (or cause to be paid) to Allergan 10% of any Qualifying Sublicense Payments within 10 days of receipt of such payments by the applicable Payment Recipients.", "": "" }, { "Text": "5.3.3 Disposition Proceeds. Licensee shall pay (or cause to be paid) to Allergan (i) 10% of the applicable Disposition Proceeds concurrently with the consummation of the first Change of Control described in Section 1.14.2 involving Licensee that is consummated following the Effective Date, and (ii) until such time as a Change of Control described in Section 1.14.2 involving Licensee, 10% of the applicable Disposition Proceeds concurrently with the consummation of any sale, assignment or transfer (other than a Sublicense Grant) by Licensee or any Affiliate of Licensee to any Person other than an Affiliate of Licensee of any right, title or interest in or to the Licensed Patents, the Licensed Know-How, the Joint Patents, the Joint Know-How, the Licensed Compound or any Licensed Product (for instance, through sale, assignment or transfer of such rights to certain territories or for certain indications). It is intended that Allergan shall be entitled to receive payments pursuant to this Section 5.3.3 with respect to the full scope of the Licensed Patents, the Licensed Know-How, the Joint Patents, the Joint Know-How, the Licensed Compound or any Licensed Products, but only one time with respect to any particular portion of such rights. Accordingly, Licensee shall (or shall cause) the payments required by clause (ii) to be made with respect each transaction involving a sale, assignment or transfer (other than a Sublicense Grant) by Licensee or an Affiliate of Licensee to a Person other than an Affiliate of Licensee of rights, title or interest in or to the Licensed Patents, the Licensed Know-How, the Joint Patents, the Joint Know-How, the Licensed Compound or any Licensed Product until the earlier of (x) the occurrence of a Change of Control described in Section 1.14.2 involving Licensee and that triggers the payment set forth in the foregoing clause (i), and (y) such time as all rights obtained by Licensee hereunder with respect to the Licensed Patents, the Licensed Know-How, the Joint Patents, the Joint Know-How, the Licensed Compound or any Licensed Product shall have been sold, assigned or transferred to Persons other than Affiliates of Licensee.", "": "" }, { "Text": "If the transactions or series of related transactions requiring a payment to be made pursuant to this Section 5.3.3 involve the direct or indirect sale, transfer or assignment of beneficial ownership of assets or rights other than rights in or to the Licensed Patents, the Licensed Know-How, the Joint Patents, the Joint Know-How, the Licensed Compound or any Licensed Product, and such other assets or rights represent a material portion of the overall assets or rights involved in such transaction, then the Parties will reasonably allocate the applicable Disposition Proceeds based on the value of the rights in or to the Licensed Patents, the Licensed Know-How, the Joint Patents, the Joint Know-How, the Licensed Compound or any Licensed Product relative to such other assets or rights using standard valuation methodologies used in the biopharmaceutical industry. If the Parties are unable to agree on such reasonable allocation, then either Party may seek a determination of such allocation by an independent valuation expert (whether an individual or a firm), with qualifications and experience in valuations in the biopharmaceutical industry and to be mutually selected by the Parties (or if the Parties cannot agree, by Allergan), to make such determination as soon as practicable. The Parties shall share equally the fees, costs and expenses of such expert, and the determination of such expert shall be final and binding on the Parties. For clarity, the foregoing allocation shall not apply for purposes of determining the Disposition Proceeds in the case of the first Change of Control described in Section 1.14.2 involving Licensee that is consummated following the Effective Date.", "": "" }, { "Text": "5.4 Mode of Payment; Currency Conversion.", "": "" }, { "Text": "(a) All Payments to Allergan under this Agreement shall be made by deposit of Dollars in the requisite amount to such bank account as Allergan may from time to time designate by notice to Licensee.", "": "" }, { "Text": "(b) If any currency conversion shall be required in connection with any payment hereunder, such conversion shall be made by using the arithmetic mean of the exchange rates for the purchase of Dollars as published in The Wall Street Journal, Eastern Edition, on the last Business Day of each month in the Calendar Quarter to which such payments relate.", "": "" }, { "Text": "5.5 Taxes. Each Party is responsible for its own taxes, duties, levies, imposts, assessments, deductions, fees, withholdings or similar charges imposed on or measured by net income or overall gross income (including branch profits), gross receipts, capital, ability or right to do business, property, and franchise or similar taxes pursuant to Applicable Law. The upfront payment, royalties and other amounts payable by a Party (the \"Payor\") to the other Party (the \"Payee\") pursuant to this Agreement (each, a \"Payment\") shall be paid free and clear of any and all taxes, except for any withholding of taxes, duties, levies, imposts, assessments, deductions, fees, and other similar charges required by Applicable Law (\"Withholding Taxes\"). If Payor takes any actions that would increase any required Withholding Taxes that otherwise would not be required absent such action, including a Change of Control, change in tax residence, sublicense or assignment of this Agreement by law or otherwise, except for any transaction currently contemplated under this Agreement, Payor shall increase the amount so payable as necessary so that after such deduction or withholding of additional Withholding Taxes has been made, Payee receives the amount it would have received had no such additional deduction or withholding been made. Notwithstanding the foregoing, if Payee is entitled under any applicable tax treaty to a reduction of rate of, or the elimination of, applicable Withholding Taxes, it may deliver to Payor or the appropriate governmental authority (with the assistance of Payor to the extent that this is reasonably requested) the prescribed forms valid under Applicable Law necessary to lawfully reduce the applicable rate of withholding or to relieve Payor of its obligation to withhold such Withholding Taxes and Payor shall apply the reduced rate of withholding, or dispense with withholding, as the case may be. If, in accordance with the foregoing, Payor withholds any amount, it shall pay to Payee the net remaining balance when due, make timely payment to the proper taxing authority of the withheld amount and send to Payee proof of such payment with reasonable supporting documentation and calculations of such Withholding Taxes sufficient to enable Payee to claim such payment of Withholding Taxes or otherwise obtain any tax benefit for such Withholding Taxes within a reasonable time following such payment, and such Withholding Taxes shall be treated for all purposes of this Agreement as having been paid to Payee hereunder. The Parties shall reasonably cooperate to minimize, report and withhold any such Withholding Taxes, including with respect to all documentation required by any taxing authority. Prior to making any deduction or withholding from any Payment under this Agreement, Payor shall provide at least 15 days' prior written notice to Payee of the amounts subject to deduction or withholding and the legal basis therefor, and provide to Payee a reasonable opportunity to, or elect to postpone a Payment in order to, furnish forms, certificates or other items that would reduce or eliminate such deduction or withholding. If Payor receives a refund of any such withheld taxes, in whole or in part, and whether in the form of cash, credit or other similar offset, Payor shall promptly refund such amount to Payee. Payee shall not be liable for any penalties or interest due to the failure of Payor to properly withhold or remit such any withholding or deductions to the governmental authorities, unless such failure is due to incorrect or invalid forms, facts, or other similar information given to Payor by Payee.", "": "" }, { "Text": "5.6 Value Added Tax. Notwithstanding anything contained in Section 5.5, this Section 5.6 shall apply with respect to value added tax, ad valorem, sales and use, goods and services or similar tax chargeable on the supply or deemed supply of goods or services, sales and use taxes, transaction taxes, consumption taxes and other similar taxes required by Applicable Law, including any interest, penalties or other additions to tax thereon, required under Applicable Law (collectively, \"VAT\"). All Payments are exclusive of VAT. If any VAT is chargeable in respect of any Payments, Payor shall timely pay VAT at the applicable rate in respect of any such Payments following the receipt of a valid VAT invoice in the appropriate form issued by Payee in respect of those Payments, where applicable, such VAT to be payable on the later of the due date of the payment of the Payments to which such VAT relates and 45 days after the receipt by Payor of the applicable valid invoice relating to that VAT payment. The Parties will reasonably cooperate to issue valid invoices for all amounts due under this Agreement consistent with VAT requirements. Allergan and Licensee shall reasonably cooperate to eliminate or minimize the amount of any such VAT imposed on the transactions contemplated in this Agreement.", "": "" }, { "Text": "5.7 Interest on Late Payments. If any Payment due to Payee under this Agreement is not paid in when due, then Payor shall pay interest thereon and on any unpaid accrued interest (before and after any judgment) at an annual rate (but with interest accruing on a daily basis) of 300 basis points above LIBOR, such interest to run from the date upon which payment of such amount became due until payment thereof in full together with such accrued interest.", "": "" }, { "Text": "5.8 Financial Records. Licensee shall, and shall cause its Sublicensees and its and their respective Affiliates to, keep complete and accurate books and records pertaining to the sale, delivery and use of the Licensed Products, including books and records of Invoiced Sales (including any deductions therefrom) and Net Sales of the Licensed Products in the Territory. Licensee shall, and shall cause its Sublicensees and its and their respective Affiliates to, retain such books and records, until the later of three years after the end of the period to which such books and records pertain and the expiration of the applicable tax statute of limitations (or any extensions thereof), or for such longer period as may be required by Applicable Law. In addition, Allergan and Licensee shall, and Licensee shall cause any Sublicensees and its and their Affiliates to, retain books and records regarding Withholding Taxes, VAT and any withholding forms, documentation or information as described in Section 5.5 or Section 5.6 until the expiration of the applicable tax statute of limitations (or any extensions thereof) or for such longer period as may be required by Applicable Law.", "": "" }, { "Text": "5.9 Audit. At the request of Allergan, Licensee shall, and shall cause its Sublicensees and its and their respective Affiliates to, permit an independent certified public accountant of nationally recognized standing retained by Allergan and that is not Allergan's auditor, at reasonable times and upon reasonable notice, to audit the books and records maintained by Licensee and its Affiliates pursuant to Section 5.8. For the books and records maintained by its Sublicensees and their Affiliates, if requested by Allergan, Licensee shall have an independent certified public accountant of nationally recognized standing retained by Licensee perform a similar audit on such Sublicensees' and their Affiliates' books and records relating to the Licensed Products directly and will include the results of such audits in Licensee's books and records that are subject of Allergan's audit rights under this Section 5.9. Such audits may not (a) be conducted for any Calendar Quarter more than three years after the end of such Calendar Quarter, (b) be conducted more than once in any Calendar Year (unless a previous audit during such Calendar Year revealed an underpayment with respect to such period or Licensee restates or revises such books and records for such 12-month period) or (c) be repeated for any Calendar Quarter. The cost of any audit shall be borne by Allergan, unless the audit reveals an underpayment of more than 5% of the amount actually owed by Licensee for any Calendar Quarter audited, in which case Licensee shall bear the cost of the audit. Unless disputed pursuant to Section 5.10, if such audit concludes that additional payments were owed or that excess payments were made during such period, Licensee shall pay the additional amounts, with interest from the date originally due as provided in Section 5.7, or Allergan shall reimburse such excess payments, in either case, within 30 days after the date on which such audit is completed and the conclusions thereof are notified to the Parties.", "": "" }, { "Text": "5.10 Audit Dispute. In the event of a dispute over the results of any audit conducted pursuant to Section 5.9, Allergan and Licensee shall work in good faith to resolve such dispute. If the Parties are unable to reach a mutually acceptable resolution of any such dispute within 30 days, the dispute shall be submitted for arbitration to a certified public accounting firm selected by each Party's certified public accountants or to such other Person as the Parties shall mutually agree (the \"Accountant\") or failing such agreement, as the Chairman of the International Chamber of Commerce (or such other body as the Parties may mutually agree), may nominate. The decision of the Accountant shall be final and the costs of such arbitration as well as the initial audit shall be borne between the Parties in such manner as the Accountant shall determine. Not later than 30 days after such decision and in accordance with such decision, Licensee shall pay the additional royalties, with interest from the date originally due as provided in Section 5.7, or Allergan shall reimburse such excess payments, as applicable.", "": "" }, { "Text": "5.11 Confidentiality. Allergan shall treat all information subject to review, and all audit reports, under this ARTICLE 5 in accordance with the confidentiality provisions of ARTICLE 7 and Allergan shall cause the independent public accountant retained by Allergan pursuant to Section 5.9 or the Accountant, as applicable, to enter into a reasonably acceptable confidentiality agreement that includes an obligation to retain all such financial information in confidence. The accountant or auditor shall only report to Allergan whether the amounts paid by Licensee during the audited period were accurate and the amount of any disparity, and shall provide Licensee a copy of any such report at the same time it is provided to Allergan.", "": "" }, { "Text": "ARTICLE 6 INTELLECTUAL PROPERTY", "": "" }, { "Text": "6.1 Ownership of Intellectual Property.", "": "" }, { "Text": "6.1.1 Ownership of Technology. Subject to the licenses granted under Section 2.1, as between the Parties, each Party shall own and retain all right, title, and interest in and to any and all: (a) Information and inventions that are conceived, discovered, developed, or otherwise made solely by or on behalf of such Party or any of its Affiliates or its or their respective (sub)licensees (including Sublicensees) in connection with the activities conducted under or in connection with this Agreement, whether or not patented or patentable, and any and all Patents and other intellectual property rights with respect thereto, except to the extent that any such Information or invention or any Patent or intellectual property rights with respect thereto is Joint Know-How or a Joint Patent, and (b) other Information, inventions, Patents and other intellectual property rights that are owned or otherwise Controlled (other than pursuant to the license grants set forth in Section 2.1) by such Party or any of its Affiliates or its or their respective (sub)licensees (including Sublicensees) as of the Effective Date or outside of this Agreement.", "": "" }, { "Text": "6.1.2 Ownership and Use of Joint Patents and Joint Know-How. Subject to the licenses granted under Section 2.1, each Party shall own an equal, undivided interest, without a duty of accounting to the other Party, in any and all: (a) Information and inventions that are conceived, discovered, developed or otherwise made jointly by or on behalf of Licensee or any of its Affiliates or its or their respective (sub)licensees (including Sublicensees), on the one hand, and Allergan or any of its Affiliates or its or their respective (sub)licensees, on the other hand, in connection with the activities conducted under or in connection with this Agreement, whether or not patented or patentable (the \"Joint Know-How\"), and (b) Patents (the \"Joint Patents\") and other intellectual property rights with respect to the Information and inventions described in clause (a) (together with Joint Know-How and Joint Patents, the \"Joint Intellectual Property Rights\"). Each Party shall promptly disclose to the other Party in writing, and shall cause its Affiliates and its and their respective (sub)licensees (including Sublicensees) to so disclose, the conception, discovery, development or making of any Joint Know-How or Joint Patents. Subject to the license grants set forth in Sections 2.1 and 10.9.2, each Party and its Affiliates and their respective (sub)licensees (including Sublicensees) shall have the right to use and otherwise exploit any Joint Intellectual Property Rights for any purpose in the Territory in any manner and for any purpose outside of this Agreement without any duty to share profits with, or provide an accounting to, the other Party with respect to such use and exploitation. If in a particular country the consent of co-owners is required for one co-owner to grant license rights under or otherwise exploit Joint Patent(s) as provided in the previous sentence, each of the Parties hereby consents to such license grant to use and otherwise exploit such Joint Patent(s) in such country without any duty to share profits with, or provide an accounting to, the other Party with respect to such use and exploitation, and each Party hereby grants to the other Party such granting Party's interest in such Joint Patent(s), a perpetual, irrevocable, royalty-free, sublicensable, non-exclusive license to exploit any Joint Patent or Joint Know-How in such country in any manner and for any purpose whatsoever.", "": "" }, { "Text": "6.1.3 United States Law. The determination of whether Information and inventions are conceived, discovered, developed, or otherwise made by a Party or any of its Affiliates or its or their respective (sub)licensees (including Sublicensees) for the purpose of allocating proprietary rights (including Patent, copyright or other intellectual property rights) therein, shall, for purposes of this Agreement, be made in accordance with Applicable Law in the United States as such law exists as of the Effective Date irrespective of where such conception, discovery, development or making occurs. Each Party shall, without additional compensation, cooperate to make any necessary assignments to fully effect the ownership provided for in Section 6.1.1 or Section 6.1.2, as applicable.", "": "" }, { "Text": "6.2 Prosecution and Maintenance of Patents. Licensee shall have the first right, but not the obligation, to prepare, file, prosecute and maintain (including to prosecute related interference, derivation, re-issuance, re-examination, opposition and other post-grant proceedings, each an \"Administrative Proceeding\") the Licensed Patents and the Joint Patents in the Territory at its sole cost and expense. If Licensee plans to abandon any Licensed Patent or Joint Patent in a country in the Territory or not control any Administrative Proceeding (which decision shall be made in good faith considering the development obligations of Licensee hereunder), Licensee shall notify Allergan in writing at least 30 days in advance of the due date of any payment or other action that is required to prosecute and maintain (including with respect to related interference, derivation, re-issuance, re-examination, opposition and other post-grant proceedings) such Licensed Patent or Joint Patent, as applicable, or prosecute such Administrative Proceeding, upon which notice such Licensed Patent shall cease to constitute a Licensed Patent or all of Licensee's interest in such Joint Patent shall be assigned to Allergan, as applicable, and Allergan may elect (at its option and without any obligation) to make such payment or take such action or otherwise prosecute and maintain such Patent in such country.", "": "" }, { "Text": "6.2.1 Cooperation. Each Party shall assist the other Party at the reasonable request of the other Party from time to time in connection with its activities set forth in Section 6.2 at the sole cost and expense of the Prosecuting Party. The Party that has the right to prepare, file, prosecute and maintain the Licensed Patents or Joint Patents, as applicable (the \"Prosecuting Party\") shall keep the other Party (the \"Non-Prosecuting Party\") informed of all material steps to be taken in the preparation and prosecution of all applications filed by it pursuant to Section 6.2 and shall furnish the Non-Prosecuting Party with copies of such applications for Patents, amendments thereto and other related material correspondence to and from patent offices, including substantive correspondence relating to any office actions, and, to the extent reasonably practicable, permit the Non-Prosecuting Party an opportunity to offer its comments thereon before making a submission to a patent office and the Prosecuting Party shall consider in good faith the Non-Prosecuting Party's comments. The Non-Prosecuting Party shall offer its comments, if any, promptly.", "": "" }, { "Text": "6.2.2 Patent Term Extension and Supplementary Protection Certificate.", "": "" }, { "Text": "(a) Licensee may request that Allergan apply for any patent term extensions, including supplementary protection certificates and any other extensions that are now or become available in the future, wherever applicable, for the Licensed Patents or Joint Patents in any country in the Territory and Allergan shall, unless Allergan has a reasonable basis not to make such filing, do so in a timely manner. Allergan shall be responsible for applying for any such extension, and Licensee shall cooperate with Allergan in applying for requested extensions of the Licensed Patents or Joint Patents, in each case at Licensee's cost and expense. Allergan shall not apply for any such extension without Licensee's consent, not to be unreasonably withheld, delayed or conditioned; provided, that if Allergan requests that Licensee consent to extend a Licensed Patent or Joint Patent that covers a Licensed Product and Licensee withholds such consent, then for purposes of determining the Royalty Term hereunder, such Licensed Patent or Joint Patent, as applicable, shall be deemed to have a Valid Claim until the date on which such Licensed Patent or Joint Patent, as applicable, would have expired had such extension been requested and granted.", "": "" }, { "Text": "6.3 Enforcement of Patents.", "": "" }, { "Text": "6.3.1 Notice. In the event either Party becomes aware of (a) any suspected infringement of any Licensed Patents or Joint Patents or (b) any certification filed under the Hatch-Waxman Act claiming that any Licensed Patents or Joint Patents are invalid or unenforceable or claiming that any Licensed Patents or Joint Patents would not be infringed by the making, use, offer for sale, sale or import of a product for which an application under the Hatch-Waxman Act is filed, or any equivalent or similar certification or notice in any other jurisdiction in the Territory (each of clauses (a) and (b), an \"Infringement\"), such Party shall promptly notify the other Party and provide it with all details of such Infringement of which it is aware (each, an \"Infringement Notice\"); provided that each Party shall give the other Party an Infringement Notice not later than three Business Days after it becomes aware of any Infringement described in clause (b) above.", "": "" }, { "Text": "6.3.2 Licensed Patents and Joint Patents. Subject to the last sentence of Section 6.3.1, Licensee shall have the first right, but not the obligation, through counsel of its choosing, to initiate an infringement action with respect to any Infringement of any Licensed Patents or Joint Patents at its sole cost and expense or, to grant the infringing Third Party adequate rights and licenses necessary for continuing such activities. If Licensee does not initiate such an infringement action within 90 days of learning of the Infringement (or 25 days of receiving the notice described in clause (b) of the definition of \"Infringement\"), or earlier notifies Allergan in writing of its intent not to so initiate an action, and Licensee has not granted such infringing Third Party rights and licenses to continue its otherwise infringing activities, then Allergan shall have the right, but not the obligation, to bring such an action; provided that, except with respect to any Infringement described in clause (b) of the definition thereof, if Licensee has commenced negotiations with an alleged infringer for discontinuance of such Infringement within such 90-day period, Licensee shall have an additional 90 days to conclude its negotiations before Allergan may bring suit for such Infringement.", "": "" }, { "Text": "6.3.3 Settlement. The Party that controls the prosecution of a given Infringement claim pursuant to Section 6.3.2 or the last sentence of Section 6.3.1 also shall have the right to control settlement of such claim; provided that no settlement shall be entered into without the prior consent of the other Party, not to be unreasonably withheld, delayed or conditioned, if such settlement would adversely affect or diminish the rights and benefits of the other Party under this Agreement, or impose any new obligations or adversely affect any obligations of the other Party under this Agreement.", "": "" }, { "Text": "6.3.4 Cooperation. In the event a Party is entitled to and brings an infringement action in accordance with this Section 6.3, the other Party shall cooperate fully, including being joined as a party plaintiff in such action, providing access to relevant documents and other evidence and making its employees available at reasonable business hours, as reasonably requested by (and at the expense of) the enforcing Party. If a Party pursues an action against such alleged Infringement, it shall consider in good faith any comments from the other Party and shall keep the other Party reasonably informed of any steps taken to preclude such Infringement.", "": "" }, { "Text": "6.3.5 Costs and Recovery. Each Party shall bear its own costs and expenses relating to any Infringement action commenced pursuant to this Section 6.3, provided that the controlling Party shall reimburse the other Party for the costs and expenses incurred by the other Party for any assistance requested by the controlling Party for such Infringement action. Any damages or other amounts collected shall be first allocated to reimburse the Parties for their costs and expenses in making such recovery (which amounts shall be allocated pro rata if insufficient to cover the totality of such expenses). Any remainder after such reimbursement is made shall be retained by the controlling Party; provided, however, that any such remainder attributable to lost sales or lost profits of a Licensed Product shall be paid to Licensee; and provided further that any amounts paid to, or retained by, Licensee that are attributable to lost sales or lost profits of a Licensed Product shall be deemed to be Net Sales (with any recoveries for lost profits being appropriately adjusted to reflect the sales associated with such profits) for purposes of the royalties that Licensee is required to pay under this Agreement.", "": "" }, { "Text": "6.4 Infringement Claims by Third Parties.", "": "" }, { "Text": "6.4.1 Defense of Third Party Claims. If a Third Party asserts that a Patent or other intellectual property right owned or otherwise controlled by it is infringed by the Exploitation of the Licensed Products in the Field in the Territory, the Party first made aware of such a claim shall promptly provide the other Party written notice of such claim along with the related facts in reasonable detail. Licensee shall have the first right, but not the obligation, to control the defense of such claim. If Licensee fails to assume control of the defense of such claim within 30 days after receiving notice thereof from, or giving notice thereof to, Allergan pursuant to the first sentence of this Section 6.4.1, Allergan shall have the right, but not the obligation, to defend against a claim against Allergan. Allergan shall not have the right to defend against a claim against Licensee. Notwithstanding the foregoing, the Party controlling such defense (the \"Controlling Party\") shall not be entitled to assert a claim or counterclaim against such Third Party based on the Patents or other intellectual property rights owned or otherwise controlled by the other Party (the \"Non-Controlling Party\") without the prior written consent of the Non-Controlling Party, except to the extent that the Controlling Party has the right to enforce such Patents or other intellectual property rights in accordance with this Agreement. The Non-Controlling Party shall cooperate with the Controlling Party, at the Controlling Party's reasonable request and expense, in any such defense and shall have the right, at its own expense, to be represented separately by counsel of its own choice in any such proceeding.", "": "" }, { "Text": "6.4.2 Settlement of Third Party Claims. The Controlling Party with respect to a particular claim pursuant to Section 6.4.1 also shall have the right to control settlement of such claim; provided that (a) no settlement shall be entered into without the prior consent of the Non-Controlling Party if such settlement would adversely affect or diminish the rights and benefits of the Non-Controlling Party under this Agreement, or impose any new obligations or adversely affect any obligations of the Non-Controlling Party under this Agreement and (b) the Controlling Party shall not be entitled to settle any such claim by granting a license or covenant not to sue under or with respect to the Patents or other intellectual property rights owned or otherwise controlled by the Non-Controlling Party without the prior written consent of the Non-Controlling Party, in each case ((a) and (b)) such consent not to be unreasonably conditioned, withheld or delayed.", "": "" }, { "Text": "6.4.3 Allocation of Costs. Subject to the last sentence of Section 6.4.1, all costs and expenses relating to any defense, settlement and judgments in actions commenced pursuant to this Section 6.4 shall be borne by the Controlling Party (other than any license fees, milestones, royalties and other payments paid or to be paid to any Third Party pursuant to any settlement entered into pursuant to Section 6.4.2 or any judgment, for which, unless otherwise agreed by the Parties in writing, Licensee shall be responsible regardless of which Party is the Controlling Party).", "": "" }, { "Text": "6.5 Invalidity or Unenforceability Defenses or Actions.", "": "" }, { "Text": "6.5.1 Third Party Defense or Counterclaim.", "": "" }, { "Text": "(a) If a Third Party asserts, as a defense or as a counterclaim in any infringement action under Section 6.3 or claim or counterclaim asserted under Section 6.4, or in a declaratory judgment action or similar action or claim filed by such Third Party, that any Licensed Patent or Joint Patent is invalid or unenforceable, then the Party pursuing or defending such infringement action, or the Party first obtaining knowledge of such declaratory judgment action, as the case may be, shall promptly give written notice to the other Party.", "": "" }, { "Text": "(b) With respect to the Licensed Patents or Joint Patents, Licensee shall have the first right, but not the obligation, through counsel of its choosing, at its sole cost and expense, to defend against such action or claim. If Licensee fails to accept control of the defense of such a claim within 90 days after receiving notice thereof from, or giving notice thereof to, Allergan pursuant to Section 6.5.1(a), Allergan shall have the right, through counsel of its choosing, at its sole cost and expense, to defend against such action or claim.", "": "" }, { "Text": "6.5.2 Assistance. Each Party shall assist and cooperate with the other Party as such other Party may reasonably request from time to time in connection with its activities set forth in Section 6.5.1, including by providing access to relevant documents and other evidence and making its employees available at reasonable business hours; provided that neither Party shall be required to disclose legally privileged information unless and until procedures reasonably acceptable to such Party are in place to protect such privilege; and provided further that the Party requesting such assistance shall bear the reasonable costs and expenses of such assistance. In connection with any such defense or claim or counterclaim, the controlling Party shall consider in good faith any comments from the other Party and shall keep the other Party reasonably informed of any steps taken, and shall provide copies of all documents filed, in connection with such defense, claim or counterclaim. In connection with the activities set forth in Section 6.5.1, each Party shall consult with the other as to the strategy for the defense of the Licensed Patents and the Joint Patents, as applicable.", "": "" }, { "Text": "6.5.3 By Licensee. Without limiting Allergan's rights under Section 10.3.2, if Licensee or any of its Sublicensees or any of its or their respective Affiliates initiates (or in any way, directly or indirectly, aids any Third Party in initiating) a declaratory judgment action or other action or claim that any Licensed Patent or Joint Patent is invalid, unenforceable or not infringed by the making, use, offer for sale, sale or import of any Licensed Products by or on behalf of Licensee, its Sublicensees or its or their respective Affiliates in the Field in the Territory, and (a) a court of competent jurisdiction upholds the validity, enforceability or infringement of such Licensed Patent or Joint Patent, as applicable, in whole or in part, (b) such action or claim is dismissed with or without prejudice, or (c) Licensee, its Sublicensee or its or their respective Affiliate, as applicable, voluntarily withdraws such action or claim, then in each case ((a), (b) and (c)), Licensee shall promptly reimburse Allergan for all costs and expenses, including fees and disbursements of counsel and experts, incurred by Allergan or any of its Affiliates in connection with defending against such invalidity, unenforceability or non-infringement action or claim.", "": "" }, { "Text": "6.6 Third Party Licenses. If, in the reasonable opinion of counsel to Licensee, the Exploitation of a Licensed Product in the Field in the Territory by Licensee, its Sublicensees or its or their respective Affiliates may infringe or misappropriate any Patent or any other intellectual property right of a Third Party in any country in the Territory, such that Licensee, its Sublicensees or its or their respective Affiliates cannot Exploit such Licensed Product in the Field in such country without infringing the Patent or other intellectual property right of such Third Party, then Licensee shall have the right, but not the obligation, to negotiate the terms of, and enter, each such license for one or more countries in the Territory. Licensee shall be responsible for all license fees, milestones, royalties or other payments due to such Third Party as a result of Licensee's, its Sublicensees' and its and their Affiliates' Exploitation of the Licensed Products.", "": "" }, { "Text": "6.7 Product Trademarks.", "": "" }, { "Text": "6.7.1 Maintenance and Prosecution of Product Trademarks. Licensee shall own all right, title, and interest to the Product Trademarks in the Territory, and shall be responsible for the registration, prosecution, and maintenance thereof. All costs and expenses of registering, prosecuting, and maintaining the Product Trademarks incurred by Licensee shall be borne solely by Licensee.", "": "" }, { "Text": "6.7.2 Enforcement of Product Trademarks. Licensee shall have the right and responsibility for taking such action as Licensee deems necessary against a Third Party based on any alleged, threatened, or actual infringement, dilution, misappropriation, or other violation of, or unfair trade practices or any other like offense relating to, the Product Trademarks by a Third Party in the Territory. Licensee shall bear the costs and expenses relating to any enforcement action commenced by or on behalf of Licensee, its Sublicensees, and it and their respective Affiliates pursuant to this Section 6.7.2 and any settlements and judgments with respect thereto, and shall retain any damages or other amounts collected in connection therewith.", "": "" }, { "Text": "6.7.3 Third Party Claims. Licensee shall have the right and responsibility for defending against any alleged, threatened, or actual claim by a Third Party that the use or registration of the Product Trademarks in the Territory infringes, dilutes, misappropriates, or otherwise violates any Trademark or other right of such Third Party or constitutes unfair trade practices or any other like offense, or any other claims as may be brought by a Third Party against a Party in connection with the use of the Product Trademarks with respect to a Licensed Product in the Territory. Licensee shall bear the costs and expenses relating to any defense commenced pursuant to this Section 6.7.3 and any settlements and judgments with respect thereto, and shall retain any damages or other amounts collected in connection therewith.", "": "" }, { "Text": "6.7.4 Notice and Cooperation. Each Party shall cooperate fully with the other Party with respect to any enforcement action or defense commenced pursuant to this Section 6.7, including being joined as a party plaintiff in such action, providing access to relevant documents and other evidence and making its employees available at reasonable business hours; provided that the cooperating Party shall be reimbursed for its costs and expenses in connection with such cooperation requested by the other Party.", "": "" }, { "Text": "ARTICLE 7 CONFIDENTIALITY AND NON-DISCLOSURE", "": "" }, { "Text": "7.1 Confidentiality Obligations. At all times during the Term and for a period of 10 years following termination or expiration of this Agreement, each Party shall, and shall cause its Affiliates and, in the case of Licensee as the Receiving Party, its Sublicensees, and its and their respective officers, directors, employees and agents to, keep completely confidential and not publish or otherwise disclose and not use, directly or indirectly, for any purpose, any Confidential Information furnished or otherwise made known to it, directly or indirectly, by the other Party, except to the extent such disclosure or use is expressly permitted by the terms of this Agreement or such use is reasonably necessary for the performance of its obligations or the exercise of its rights under this Agreement. \"Confidential Information\" means any information provided by one Party (the \"Disclosing Party\") to the other Party (the \"Receiving Party\") under or in connection with this Agreement, including any information relating to the Licensed Products (including the Regulatory Documentation and Regulatory Approvals and any information or data contained therein), any Exploitation of the Licensed Products in the Field in the Territory or the scientific, regulatory or business affairs or other activities of either Party. The Parties acknowledge and agree that (a) prior to the Effective Date, Allergan, Inc. and Parent exchanged certain information under that certain Confidential Information Disclosure Agreement between Allergan, Inc. and Parent dated August 3, 2017 (the \"Prior CDA\") and to the extent any such information constitutes Confidential Information pursuant to the terms hereof, such information shall be deemed Confidential Information for purposes of this Agreement and shall be subject to the terms and conditions of this ARTICLE 7 and (b) Joint Know-How and the terms of this Agreement shall be deemed to be the Confidential Information of both Parties, and both Parties shall be deemed to be the Receiving Party and the Disclosing Party with respect thereto. Notwithstanding the foregoing, Confidential Information shall not include any information that:", "": "" }, { "Text": "7.1.1 is or hereafter becomes part of the public domain by public use, publication, general knowledge or the like through no wrongful act, fault or negligence on the part of, or breach of this Agreement or the Prior CDA by, the Receiving Party;", "": "" }, { "Text": "7.1.2 can be demonstrated by documentation or other competent proof to have been in the Receiving Party's possession prior to disclosure by the Disclosing Party without any obligation of confidentiality with respect to such information;", "": "" }, { "Text": "7.1.3 is subsequently received by the Receiving Party on a non-confidential basis from a Third Party who is not, to the knowledge of the Receiving Party, bound by any obligation of confidentiality with respect to such information; or", "": "" }, { "Text": "7.1.4 can be demonstrated by documentation or other competent evidence to have been independently developed by or for the Receiving Party without use of or reference to the Disclosing Party's Confidential Information.", "": "" }, { "Text": "Specific aspects or details of Confidential Information shall not be deemed to be within the public domain or in the possession of the Receiving Party merely because the Confidential Information is embraced by more general information in the public domain or in the possession of the Receiving Party. Further, any combination of Confidential Information shall not be considered in the public domain or in the possession of the Receiving Party merely because individual elements of such Confidential Information are in the public domain or in the possession of the Receiving Party unless the combination and its principles are in the public domain or in the possession of the Receiving Party.", "": "" }, { "Text": "7.2 Permitted Disclosures. Each Receiving Party may disclose Confidential Information disclosed to it by the Disclosing Party to the extent that such disclosure by the Receiving Party is:", "": "" }, { "Text": "7.2.1 made in response to a valid order of a court of competent jurisdiction or other supra-national, federal, national, regional, state, provincial and local governmental or regulatory body of competent jurisdiction or, if in the reasonable opinion of the Receiving Party's legal counsel, such disclosure is otherwise required by Applicable Law or the requirements of a national securities exchange or other similar regulatory body; provided that the Receiving Party shall first have given notice, to the extent legally permitted, to the Disclosing Party and given the Disclosing Party a reasonable opportunity to quash such order and to obtain a protective order requiring that the Confidential Information and documents that are the subject of such order or required by Applicable Law to be disclosed be held in confidence by such court or agency or, if disclosed, be used only for the purposes for which the order was issued or such disclosure was required by Applicable Law; and provided further that if a disclosure order is not quashed or a protective order is not obtained, the Confidential Information disclosed in response to such court or governmental order or as required by Applicable Law shall be limited to the information that is legally required to be disclosed in response to such court or governmental order or by such Applicable Law;", "": "" }, { "Text": "7.2.2 made by the Receiving Party to a Regulatory Authority as required in connection with any filing, application or request for Regulatory Approval; provided that reasonable measures shall be taken to obtain confidential treatment of such information;", "": "" }, { "Text": "7.2.3 made by the Receiving Party as necessary to file or prosecute Patent applications pursuant to Section 6.2, prosecute or defend litigation or otherwise establish rights or enforce obligations under this Agreement; provided that reasonable measures shall be taken to obtain confidential treatment of such information; or", "": "" }, { "Text": "7.2.4 made by the Receiving Party to actual or prospective acquirers, investors, merger candidates, or, with respect to Allergan as the Receiving Party, investors in connection with a Monetization (and to its and their respective Affiliates, representatives and financing sources); provided that each such Third Party to whom information is disclosed shall (a) be subject to reasonable obligations of confidentiality substantially similar to the confidentiality obligations set forth in this Agreement, and (b) be informed of the confidential nature of the Confidential Information so disclosed.", "": "" }, { "Text": "7.3 Use of Name. Except as expressly provided in this Agreement, neither Party shall mention or otherwise use the name, insignia, symbol, or other Trademark of the other Party (or any abbreviation or adaptation thereof) in any publication, press release, marketing and promotional material or other form of publicity without the prior written approval of such other Party in each instance, such approval not be unreasonably conditioned, withheld or delayed. The restrictions imposed by this Section 7.3 shall not prohibit either Party from making any disclosure (a) identifying the other Party as a counterparty to this Agreement to its investors, (b) that is required by Applicable Law or the requirements of a national securities exchange or another similar regulatory body (provided that any such disclosure shall be governed by this ARTICLE 7) or (c) with respect to which written consent has previously been obtained. Further, the restrictions imposed on each Party under this Section 7.3 are not intended, and shall not be construed, to prohibit a Party from identifying the other Party in its internal business communications, provided that any Confidential Information in such communications remains subject to this ARTICLE 7.", "": "" }, { "Text": "7.4 Press Releases. Neither Party shall issue any press release or other similar public communication relating to this Agreement, its subject matter or the transactions covered by it, or the activities of the Parties under or in connection with this Agreement, without the prior written approval of the other Party, not to be unreasonably withheld, delayed or conditioned, except (a) for communications required by Applicable Law as reasonably advised by the issuing Party's counsel (provided that the other Party is given a reasonable opportunity to review and comment on any such press release or public communication in advance thereof to the extent legally permitted and the issuing Party shall act in good faith to incorporate any comments provided by the other Party on such press release or public communication), (b) for information that has been previously disclosed publicly or (c) as otherwise set forth in this Agreement.", "": "" }, { "Text": "7.5 Publications. Allergan recognizes that the publication of papers regarding results of and other Information regarding activities under this Agreement by Licensee, including oral presentations and abstracts, may be beneficial to both Parties, provided that such publications are subject to reasonable controls to protect Confidential Information. Accordingly, Allergan shall at all times have the right to review and approve any paper proposed for publication by Licensee, including any oral presentation or abstract, that contains Confidential Information of Allergan. Before any such paper is submitted for publication or an oral presentation is made, Licensee shall deliver a complete copy of the paper or materials for oral presentation to Allergan at least 45 days prior to submitting the paper to a publisher or making the presentation. Allergan shall review any such paper and give its comments to Licensee, and if applicable, notify Licensee whether Allergan approves of such paper, in each case within 30 days after the delivery of such paper to Allergan. With respect to oral presentation materials and abstracts, Allergan shall make reasonable efforts to expedite review of such materials and abstracts, and shall return such items as soon as practicable to Licensee with appropriate comments, if any, but in no event later than 30 days after the date of delivery to Allergan. Failure to respond within such 30 days shall be deemed approval to publish or present. Notwithstanding the foregoing, Licensee shall comply with Allergan's written request to (i) delete references to Allergan's Confidential Information in any such paper or presentation or (ii) withhold publication of any such paper or any presentation of same for an additional 60 days in order to permit Allergan to obtain patent protection if Allergan deems it necessary. Any publication shall include recognition of the contributions of Allergan according to standard practice for assigning scientific credit, either through authorship or acknowledgement, as may be appropriate. Licensee shall use commercially reasonable efforts to cause investigators and institutions participating in Clinical Trials for the Licensed Products in the Field with which it contracts to agree to terms substantially similar to those set forth in this Section 7.5, which efforts shall satisfy Licensee's obligations under this Section 7.5 with respect to such investigators and institutions. Allergan shall not publish any paper regarding the Licensed Compound or any Licensed Product in the Field, including oral presentations and abstracts, without Licensee's prior written consent.", "": "" }, { "Text": "7.6 Return or Destruction of Confidential Information. Within 90 days after the earliest of (a) the expiration of the Term, (b) the termination of this Agreement, and (c) the written request of the Disclosing Party, the Receiving Party shall, at the Disclosing Party's discretion, promptly destroy or return to the Disclosing Party all documentary, electronic or other tangible embodiments of the Disclosing Party's Confidential Information to which the Receiving Party does not retain rights hereunder and any and all copies thereof, and destroy those portions of any documents that incorporate or are derived from the Disclosing Party's Confidential Information to which the Receiving Party does not retain rights hereunder, and provide a written certification of such destruction, except that the Receiving Party may retain (i) such Confidential Information to the extent that the Receiving Party requires it for the purpose of performing any obligations or exercising any rights under this Agreement that may survive such expiration or termination, or one copy for archival purposes, and (ii) such other information as required to comply with Applicable Law. Notwithstanding the foregoing, the Receiving Party also shall be permitted to retain such additional copies of or any computer records or files containing the Disclosing Party's Confidential Information that have been created solely by the Receiving Party's automatic archiving and back-up procedures, to the extent created and retained in a manner consistent with the Receiving Party's standard archiving and back-up procedures, but not for any other use or purpose. Any retained Confidential Information shall continue to be subject to the non-use and non-disclosure obligations under this Agreement for the period set forth in Section 7.1.", "": "" }, { "Text": "ARTICLE 8 REPRESENTATIONS AND WARRANTIES", "": "" }, { "Text": "8.1 Mutual Representations and Warranties. Each Party hereby represents and warrants to the other Party as of the Effective Date as follows:", "": "" }, { "Text": "8.1.1 Corporate Authority. Such Party (a) has the power and authority and the legal right to enter into this Agreement and perform its obligations hereunder and (b) has taken all necessary action on its part required to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder. This Agreement has been duly executed and delivered by such Party and constitutes a legal, valid and binding obligation of such Party and is enforceable against it in accordance with its terms subject to the effects of bankruptcy, insolvency or other laws of general application affecting the enforcement of creditor rights and judicial principles affecting the availability of specific performance and general principles of equity, whether enforceability is considered in a proceeding at law or equity.", "": "" }, { "Text": "8.1.2 Consents and Approvals. All necessary consents, approvals and authorizations of all Regulatory Authorities and other Persons required to be obtained by such Party in connection with the execution and delivery of this Agreement and the performance of its obligations hereunder have been obtained, except with respect to Licensee, any consent, approval and authorization from a Regulatory Authority that may be required for Licensee to conduct a Clinical Trial involving a Licensed Product in the Territory or to seek or obtain Regulatory Approval of a Licensed Product in the Field in any country within the Territory.", "": "" }, { "Text": "8.1.3 Conflicts. The execution and delivery of this Agreement and the performance of such Party's obligations hereunder (a) do not conflict with or violate any requirement of Applicable Law in any material respect or any provision of the articles of incorporation or bylaws of such Party and (b) do not in any material respect conflict with, violate or breach or constitute a default or require any consent under, any contractual obligation or court or administrative order by which such Party is bound.", "": "" }, { "Text": "8.2 Debarment. None of Licensee or any of its Sublicensees or any of its or their Affiliates has been debarred or is subject to debarment and none of Licensee or any of its Sublicensees or any of its Affiliates will use in any capacity, in connection with the activities to be performed under this Agreement, any Person who has been debarred pursuant to Section 306 of the FFDCA or who is the subject of a conviction described in such section. Licensee shall inform Allergan in writing immediately if it or any Person who is performing activities hereunder is debarred or is the subject of a conviction described in Section 306 or if any action, suit, claim, investigation or legal or administrative proceeding is pending or, to the best of Licensee's, its Sublicensees' and its and their Affiliates' Knowledge, is threatened, relating to the debarment or conviction of Licensee or any Person performing activities hereunder.", "": "" }, { "Text": "8.3 Additional Representations of Allergan. Allergan further represents and warrants to Licensee that, as of the Original Effective Date:", "": "" }, { "Text": "8.3.1 As to the Licensed Patents filed or issued as of the Original Effective Date, all Licensed Patents listed on Schedule 1.64 are (a) to Allergan's Knowledge, the only Patents Controlled by Allergan that Cover the importation, making, using or selling of the Licensed Products in the Field as such Licensed Products exist as of the Original Effective Date and (b) Controlled by Allergan or its Affiliates.", "": "" }, { "Text": "8.3.2 To the Knowledge of Allergan, except for the Allergan Agreements, neither Allergan nor its Affiliates are a party to any agreement with any Third Parties with respect to the Development or Commercialization of any Licensed Product and Allergan has the right to grant the licenses and rights granted to Licensee under the Licensed Technology, Licensed Compound and Allergan Regulatory Documentation pursuant to this Agreement.", "": "" }, { "Text": "8.3.3 To the Knowledge of Allergan, except for the Allergan Agreements and any agreements that are no longer in force or effect as of the Original Effective Date, neither Allergan nor any of its Affiliates has previously assigned, transferred, licensed, or conveyed their right, title, or interest in or to the Licensed Patents, Licensed Know-How, Allergan Regulatory Documentation, the Licensed Compound, or a Licensed Product (including by granting any covenant not to sue with respect thereto) or any Patent or other intellectual property or proprietary right, Regulatory Documentation or Information that would be Licensed Patents, Licensed Know-How, or Allergan Regulatory Documentation, as applicable, but for such assignment, transfer, license or conveyance, in each case in the Field, and other than the licenses and rights granted to Licensee under this Agreement.", "": "" }, { "Text": "8.3.4 To the Knowledge of Allergan, no claim or litigation has been brought or threatened in writing by any Person alleging that, and neither Allergan nor any of its Affiliates have any Knowledge of any claim, whether or not asserted, that (a) the Licensed Patents are invalid or unenforceable, or (b) Exploitation of the Licensed Compound or a Licensed Product in the Field in the Territory, violates, infringes, constitutes misappropriation or otherwise conflicts or interferes with, any intellectual property or proprietary right of any Person.", "": "" }, { "Text": "8.3.5 To the Knowledge of Allergan, the inventions claimed by the Licensed Patents (a) were not conceived, discovered, developed, or otherwise made under any research activities funded, in whole or in part, by the federal government of the United States or any agency thereof; (b) are not a \"subject invention\" as that term is described in 35 U.S.C. Section 201(e); and (c) are not otherwise subject to the provisions of the Patent and Trademark Law Amendments Act of 1980, as amended, codified at 35 U.S.C. §§210-212, as amended, as well as any regulations promulgated pursuant thereto, including in 37 C.F.R. Part 401.", "": "" }, { "Text": "8.4 Intentionally Omitted.", "": "" }, { "Text": "8.5 DISCLAIMER OF WARRANTY. EXCEPT FOR THE EXPRESS WARRANTIES SET FORTH IN SECTION 2.9 (THE LAST SENTENCE), SECTION 8.1, SECTION 8.2 AND SECTION 8.3, NEITHER PARTY MAKES ANY REPRESENTATIONS OR GRANTS ANY WARRANTY, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE, AND EACH PARTY SPECIFICALLY DISCLAIMS ANY OTHER WARRANTIES, WHETHER WRITTEN OR ORAL, OR EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF QUALITY, MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE OR PURPOSE OR ANY WARRANTY AS TO THE VALIDITY OF ANY PATENTS OR THE NON-INFRINGEMENT OF ANY INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES.", "": "" }, { "Text": "8.6 ADDITIONAL WAIVER. EXCEPT FOR THE EXPRESS WARRANTIES SET FORTH IN SECTION 8.3, LICENSEE AGREES THAT: (A) THE LICENSED PATENTS AND LICENSED KNOW-HOW ARE LICENSED, AND THE TRANSFERRED COMPOUNDS ARE TRANSFERRED, \"AS IS,\" \"WITH ALL FAULTS,\" AND \"WITH ALL DEFECTS,\" AND LICENSEE EXPRESSLY WAIVES ALL RIGHTS TO MAKE ANY CLAIM WHATSOEVER AGAINST ALLERGAN FOR MISREPRESENTATION OR FOR BREACH OF PROMISE, GUARANTEE OR WARRANTY OF ANY KIND RELATING TO THE LICENSED PATENTS OR LICENSED KNOW-HOW; (B) ALLERGAN WILL HAVE NO LIABILITY TO LICENSEE FOR ANY ACT OR OMISSION IN THE PREPARATION, FILING, PROSECUTION, MAINTENANCE, ENFORCEMENT, DEFENSE OR OTHER HANDLING OF THE LICENSED PATENTS OR LICENSED KNOW-HOW; (C) ALLERGAN WILL HAVE NO LIABILITY TO LICENSEE ARISING OUT OF OR RELATED TO THE TRANSFERRED COMPOUNDS; AND (D) LICENSEE IS SOLELY RESPONSIBLE FOR DETERMINING WHETHER THE LICENSED PATENTS HAVE APPLICABILITY OR UTILITY IN LICENSEE'S CONTEMPLATED EXPLOITATION OF THE LICENSED PRODUCTS, AND LICENSEE ASSUMES ALL RISK AND LIABILITY IN CONNECTION WITH SUCH DETERMINATION.", "": "" }, { "Text": "ARTICLE 9 INDEMNITY", "": "" }, { "Text": "9.1 Indemnification of Allergan. Licensee shall indemnify Allergan, its Affiliates and its and their respective directors, officers, employees and agents (collectively, \"Allergan Indemnitees\"), and defend and hold each of them harmless, from and against any and all losses, damages, liabilities, costs and expenses (including reasonable attorneys' fees and expenses) (collectively, \"Losses\") in connection with any and all suits, investigations, claims or demands of Third Parties (collectively, \"Third Party Claims\") arising from or occurring as a result of: (a) the breach by Licensee of any term of this Agreement, (b) the negligence or willful misconduct on the part of any Licensee Indemnitee or (c) the Exploitation of the Licensed Compound or Licensed Products by or on behalf of Licensee, its Sublicensees or any of its or their respective Affiliates; provided that, with respect to any Third Party Claim for which Licensee has an obligation to any Allergan Indemnitee pursuant to this Section 9.1 and Allergan has an obligation to any Licensee Indemnitee pursuant to Section 9.2, each Party shall indemnify each of the Allergan Indemnitees or the Licensee Indemnitees, as applicable, for its Losses to the extent of its responsibility, relative to the other Party.", "": "" }, { "Text": "9.2 Indemnification of Licensee. Allergan shall indemnify Licensee, its Affiliates and its and their respective directors, officers, employees and agents (collectively, \"Licensee Indemnitees\"), and defend and hold each of them harmless, from and against any and all Losses in connection with any and all Third Party Claims arising from or occurring as a result of: (a) the breach by Allergan of this Agreement or (b) the negligence or willful misconduct on the part of any Allergan Indemnitee; provided that, with respect to any Third Party Claim for which Allergan has an obligation to any Licensee Indemnitee pursuant to this Section 9.2 and Licensee has an obligation to any Allergan Indemnitee pursuant to Section 9.1, each Party shall indemnify each of the Allergan Indemnitees or the Licensee Indemnitees, as applicable, for its Losses to the extent of its responsibility, relative to the other Party.", "": "" }, { "Text": "9.3 Notice of Claim. All indemnification claims in respect of an Allergan Indemnitee or a Licensee Indemnitee shall be made solely by Allergan or Licensee, as applicable (each of Allergan or Licensee in such capacity, the \"Indemnified Party\"). The Indemnified Party shall give the Indemnifying Party prompt written notice (an \"Indemnification Claim Notice\") of any Losses or discovery of fact upon which such Indemnified Party intends to base a request for indemnification under Section 9.1 or Section 9.2, but in no event shall the Indemnifying Party be liable for any Losses to the extent such Losses result from any delay in providing such notice. Each Indemnification Claim Notice must contain a description of the claim and the nature and amount of such Loss (to the extent that the nature and amount of such Loss is known at such time). The Indemnified Party shall furnish promptly to the Indemnifying Party copies of all papers and official documents received in respect of any Losses and Third Party Claims.", "": "" }, { "Text": "9.4 Control of Defense.", "": "" }, { "Text": "9.4.1 Control of Defense. At its option, the Indemnifying Party may assume the defense of any Third Party Claim by giving written notice to the Indemnified Party within 30 days after the Indemnifying Party's receipt of an Indemnification Claim Notice. The assumption of the defense of a Third Party Claim by the Indemnifying Party shall not be construed as an acknowledgment that the Indemnifying Party is liable to indemnify any Allergan Indemnitee or Licensee Indemnitee, as applicable, in respect of the Third Party Claim, nor shall it constitute a waiver by the Indemnifying Party of any defenses it may assert against an Allergan Indemnitee's or a Licensee Indemnitee's, as applicable, claim for indemnification. Upon assuming the defense of a Third Party Claim, the Indemnifying Party may appoint as lead counsel in the defense of the Third Party Claim any legal counsel selected by the Indemnifying Party to which the Indemnified Party does not reasonably object. In the event the Indemnifying Party assumes the defense of a Third Party Claim, the Indemnified Party shall promptly deliver to the Indemnifying Party all original notices and documents (including court papers) received by any Allergan Indemnitee or Licensee Indemnitee, as applicable, in connection with such Third Party Claim. If the Indemnifying Party assumes the defense of a Third Party Claim, except as provided in Sections 9.4.2 and 9.4.4, the Indemnifying Party shall not be liable to the Indemnified Party for any legal expenses subsequently incurred by such Indemnified Party or any Allergan Indemnitee or Licensee Indemnitee, as applicable, in connection with the analysis, defense or settlement of such Third Party Claim.", "": "" }, { "Text": "9.4.2 Right to Participate in Defense. Without limiting Section 9.4.1, any Indemnified Party shall be entitled to participate in, but not control, the defense of a Third Party Claim and to employ counsel of its choice for such purpose; provided that such employment shall be at the Indemnified Party's own expense unless (a) the employment thereof has been specifically authorized or requested by the Indemnifying Party in writing, (b) the Indemnifying Party has failed to assume the defense and employ counsel in accordance with Section 9.4.1 (in which case the Indemnified Party shall control the defense) or (c) the interests of the Indemnified Party and any Allergan Indemnitee or Licensee Indemnitee, as applicable, on the one hand, and the Indemnifying Party, on the other hand, with respect to such Third Party Claim are sufficiently adverse to prohibit the representation by the same counsel of all such Persons under Applicable Law, ethical rules or equitable principles.", "": "" }, { "Text": "9.4.3 Settlement. With respect to any Third Party Claims relating solely to the payment of money damages in connection with a Third Party Claim that shall not result in any Allergan Indemnitee or Licensee Indemnitee, as applicable, becoming subject to injunctive or other relief or otherwise adversely affecting the business of any Allergan Indemnitee or Licensee Indemnitee, as applicable, in any manner and as to which the Indemnifying Party shall have acknowledged in writing the obligation to indemnify such Allergan Indemnitee or Licensee Indemnitee, as applicable, hereunder, the Indemnifying Party shall have the sole right to consent to the entry of any judgment, enter into any settlement or otherwise dispose of such Third Party Claim, on such terms as the Indemnifying Party, in its sole discretion, shall deem appropriate. With respect to all other Third Party Claims, for which the Indemnifying Party has assumed the defense of the Third Party Claim in accordance with Section 9.4.1, the Indemnifying Party shall have authority to consent to the entry of any judgment, enter into any settlement or otherwise dispose of such Third Party Claim, provided that it obtains the prior written consent of the Indemnified Party (such consent not to be unreasonably conditioned, withheld or delayed). The Indemnifying Party shall not be liable for any settlement or other disposition of a Third Party Claim by an Allergan Indemnitee or a Licensee Indemnitee that is reached without the prior written consent of the Indemnifying Party. Regardless of whether the Indemnifying Party chooses to defend or prosecute any Third Party Claim, the Indemnified Party shall not, and the Indemnified Party shall ensure that each Allergan Indemnitee or Licensee Indemnitee, as applicable, does not, admit any liability with respect to or settle, compromise or discharge, any Third Party Claim without the prior written consent of the Indemnifying Party, such consent not to be unreasonably conditioned, withheld or delayed.", "": "" }, { "Text": "9.4.4 Cooperation. Regardless of whether the Indemnifying Party chooses to defend or prosecute any Third Party Claim, the Indemnified Party shall, and shall cause each Allergan Indemnitee or Licensee Indemnitee, as applicable, to, cooperate in the defense or prosecution thereof and shall furnish such records, information and testimony, provide such witnesses and attend such conferences, discovery proceedings, hearings, trials and appeals as may be reasonably requested in connection therewith. Such cooperation shall include access during normal business hours afforded to the Indemnifying Party to, and reasonable retention by the Indemnified Party and any Allergan Indemnitee or Licensee Indemnitee, as applicable, of, records and information that are reasonably relevant to such Third Party Claim, and making all Allergan Indemnitees or Licensee Indemnitees, as applicable, and other employees and agents available on a mutually convenient basis to provide additional information and explanation of any material provided hereunder; provided that neither Party shall be required to disclose legally privileged information unless and until procedures reasonably acceptable to such Party are in place to protect such privilege; and provided further the Indemnifying Party shall reimburse the Indemnified Party for all its reasonable costs and expenses in connection therewith.", "": "" }, { "Text": "9.4.5 Expenses. Except as provided above, the costs and expenses, including fees and disbursements of counsel, incurred by the Indemnified Party in connection with any Third Party Claim shall be reimbursed on a Calendar Quarter basis by the Indemnifying Party, without prejudice to the Indemnifying Party's right to contest any Allergan Indemnitee's or Licensee Indemnitee's, as applicable, right to indemnification and subject to refund in the event the Indemnifying Party is ultimately held not to be obligated to indemnify an Allergan Indemnitee or Licensee Indemnitee, as applicable.", "": "" }, { "Text": "9.5 Limitation on Damages and Liability. EXCEPT IN CIRCUMSTANCES OF GROSS NEGLIGENCE OR INTENTIONAL MISCONDUCT BY A PARTY (OR IN THE CASE OF LICENSEE, ITS SUBLICENSEES OR DISTRIBUTORS) OR ITS AFFILIATES, OR WITH RESPECT TO THIRD PARTY CLAIMS UNDER SECTION 9.1 OR SECTION 9.2, OR WITH RESPECT TO A BREACH OF ARTICLE 7, NEITHER PARTY NOR ANY OF THEIR RESPECTIVE AFFILIATES SHALL BE LIABLE TO THE OTHER PARTY OR THE OTHER ALLERGAN INDEMNITEES OR OTHER LICENSEE INDEMNITEES, AS APPLICABLE, FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, OR FOR LOST PROFITS, WHETHER IN CONTRACT, WARRANTY, NEGLIGENCE, TORT, STRICT LIABILITY OR OTHERWISE, ARISING OUT OF THIS AGREEMENT, INCLUDING AS A RESULT OF (a) THE DEVELOPMENT, MANUFACTURE, USE OR SALE OF THE LICENSED PRODUCTS UNDER THIS AGREEMENT, (b) THE USE OF OR REFERENCE TO THE LICENSED PATENTS, JOINT PATENTS, LICENSED KNOW-HOW, JOINT KNOW-HOW OR REGULATORY DOCUMENTATION OR (c) ANY BREACH OF OR FAILURE TO PERFORM ANY OF THE PROVISIONS OF THIS AGREEMENT.", "": "" }, { "Text": "9.6 Insurance. Licensee shall, and shall cause its Sublicensees and its and their respective Affiliates (to the extent such Affiliates are undertaking activities with respect to Licensed Products) to, obtain prior to commencing any Clinical Trials, and maintain during any period in which Licensee has indemnification obligations to Allergan, which indemnification obligations shall be scheduled in the policies, (a) commercial general liability insurance with a combined single limit for bodily injury and property damage of not less than $5 million per occurrence and $10 million in the aggregate, (b) products liability/completed operations (including Clinical Trials) coverage with a minimum indemnity limit of $10 million per occurrence, and if such coverage is on a claims-made basis it must provide a right to elect an extended reporting period for claims of at least five years after the end of the Term, (c) an all-risks insurance policy covering its facilities, including any risk of business interruption, with a minimum indemnity limit of $10 million per occurrence, and (d) an error and omission coverage covering all Manufacturing activities performed by subcontractors, if applicable. Such policies shall (x) be issued by a recognized insurer rated by A.M. Best \"A-VII\" (or its equivalent) or better, or an insurer pre-approved in writing by Allergan, (y) except for products liability/complete operations coverage, be written on an occurrence (and not a claims made) basis, and (z) show Allergan and other Allergan Indemnitees as additional insureds and loss payees, as their interests may appear, and provide that Allergan shall be given 30 days advance written notice of the nonrenewal or termination thereof or of any other material change thereto. Such policies shall remain in effect throughout the Term and for a period of five years thereafter and shall not be cancelled or subject to a reduction of coverage without the prior written authorization of Allergan. If Licensee at any time or for any reason fails to obtain the insurance required herein, or if such insurance is cancelled or the above limits reduced, Allergan shall have the right to procure the same at Licensee's expense. Allergan shall have the right to offset any such expense that is owed by Licensee but not paid against any payments owed by Allergan, if any, under this Agreement. Maintenance of such insurance coverage shall not relieve Licensee of any responsibility under this Agreement for damages in excess of insurance limits or otherwise.", "": "" }, { "Text": "ARTICLE 10 TERM AND TERMINATION", "": "" }, { "Text": "10.1 Term. This Agreement shall commence on the Effective Date and shall, unless earlier terminated in accordance with this ARTICLE 10, continue (a) with respect to each Licensed Product in each country in the Territory, until the expiration of the Royalty Term for such Licensed Product in such country and (b) with respect to this Agreement in its entirety, until the expiration of the Royalty Term for the last Licensed Product for which there has been a First Commercial Sale in the Territory (such period, the \"Term\"). Upon expiration, but not earlier termination, of this Agreement pursuant to clause (b) above, the licenses granted to Licensee in Section 2.1 shall become fully paid-up (subject to Licensee's obligations under Section 5.1.2), royalty-free, perpetual and irrevocable.", "": "" }, { "Text": "10.2 Termination of this Agreement for Material Breach. If either Party materially breaches this Agreement (such Party, the \"Breaching Party\"), in addition to any other right and remedy the other Party (the \"Complaining Party\") may have, the Complaining Party may terminate this Agreement, in its entirety upon 60 days' prior written notice (the \"Termination Notice Period\") to the Breaching Party, specifying the material breach and its claim of right to terminate, provided that the termination shall not become effective at the end of the Termination Notice Period if the Breaching Party cures the material breach complained of during the Termination Notice Period, except in the case of a payment breach, as to which the Breaching Party shall have only a 20-day cure period.", "": "" }, { "Text": "10.3 Termination by Allergan.", "": "" }, { "Text": "10.3.1 Allergan shall have the right to terminate this Agreement immediately upon written notice to Licensee if:", "": "" }, { "Text": "(a) Licensee fails to meet any of the diligence obligations set forth in Section 3.1.2(b) by the dates set forth therein (or such later date as extended pursuant to Section 3.1.2(b)(ii)), provided that the termination shall not become effective if Licensee cures such failure within 60 days of receipt of the written notice from Allergan; or", "": "" }, { "Text": "(b) Licensee's Development of all Licensed Products has permanently ceased and a Licensed Product is not being Commercialized in the Territory by or on behalf of Licensee; provided that (i) the normal pauses or gaps between or following Clinical Trials or other studies for the analysis of data, preparation of reports and design of future Clinical Trials or preparation of regulatory filings and other customary development functions not constituting Clinical Trials, or (ii) subject to the proviso in the definition thereof, a Good Reason, in each case ((i) and (ii)) does not constitute a cessation of Development or Commercialization, as applicable.", "": "" }, { "Text": "10.3.2 In the event that Licensee or any of its Sublicensees or its or their Affiliates, anywhere in the Territory, institutes, prosecutes, or otherwise participates in (or in any way aids any Third Party in instituting, prosecuting, or participating in), at law or in equity or before any administrative or regulatory body, including the U.S. Patent and Trademark Office or its foreign counterparts, any claim, demand, action, or cause of action for declaratory relief, damages, or any other remedy, or for an enjoinment, injunction, or any other equitable remedy, including any interference, re-examination, opposition, or any similar proceeding, alleging that any claim in a Licensed Patent is invalid, unenforceable, or otherwise not patentable or would not be infringed by Licensee's activities absent the rights and licenses granted hereunder (each, a \"Patent Challenge\"), Allergan shall have the right to immediately terminate this Agreement in its entirety, including the rights of any Sublicensees, upon written notice to Licensee if such Patent Challenge is not withdrawn with prejudice within 30 days of written notice from Allergan. Notwithstanding anything to the contrary herein, a Patent Challenge does not include, and termination by Allergan under this Section 10.3.2 is not permitted for any counterclaim made, filed or maintained by Licensee as defendants in any patent infringement claim, demand, lawsuit, cause of action or other action made, filed or maintained by Allergan or Allergan's Affiliate(s) or licensees with respect to products other than Licensed Products.", "": "" }, { "Text": "10.3.3 Allergan may immediately terminate this Agreement upon written notice to Licensee if any payment required to be made pursuant to Section 5.3.3 is not made within five Business Days of the date specified therefor.", "": "" }, { "Text": "10.4 Intentionally Omitted.", "": "" }, { "Text": "10.5 Termination at Will by Licensee. Prior to making the First Commercial Sale of a Licensed Product in the Territory, Licensee shall have the right to terminate this Agreement upon 90 days' prior written notice to Allergan.", "": "" }, { "Text": "10.6 Intentionally Omitted.", "": "" }, { "Text": "10.7 Termination Upon Insolvency. Each Party may terminate this Agreement if, at any time, the other Party (a) files in any court or agency pursuant to any statute or regulation of any state, country or jurisdiction, a petition in bankruptcy or insolvency or for reorganization or for an arrangement or for the appointment of a receiver or trustee of such other Party or of its assets, (b) proposes a written agreement of composition or extension of its debts, (c) is served with an involuntary petition against it, filed in any insolvency proceeding that is not dismissed within 60 days after the filing thereof, (d) proposes or is a party to any dissolution or liquidation, or (e) makes an assignment for the benefit of its creditors.", "": "" }, { "Text": "10.8 Rights in Bankruptcy. All rights and licenses granted under or pursuant to this Agreement by Licensee or Allergan are, and shall otherwise be deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code, licenses of right to \"intellectual property\" as defined under Section 101 of the U.S. Bankruptcy Code. The Parties agree that the Parties, as licensees of such rights under this Agreement, shall retain and may fully exercise all of their rights and elections under the U.S. Bankruptcy Code. The Parties further agree that, in the event of the commencement of a bankruptcy proceeding by or against either Party under the U.S. Bankruptcy Code, the Party that is not a party to such proceeding shall be entitled to a complete duplicate of (or complete access to, as appropriate) any such intellectual property and all embodiments of such intellectual property, which, if not already in the non-subject Party's possession, shall be promptly delivered to it (a) upon any such commencement of a bankruptcy proceeding upon the non-subject Party's written request therefor, unless the Party subject to such proceeding elects to continue to perform all of its obligations under this Agreement or (b) if not delivered under (a) above, following the rejection of this Agreement by or on behalf of the Party subject to such proceeding upon written request therefor by the non-subject Party.", "": "" }, { "Text": "10.9 Consequences of Termination. In the event of any early termination (but not expiration) of this Agreement:", "": "" }, { "Text": "10.9.1 All rights and licenses granted by Allergan hereunder shall immediately terminate;", "": "" }, { "Text": "10.9.2 In the event of any early termination of this Agreement by Allergan pursuant to Sections 10.2 and 10.3, to the extent requested in writing by Allergan within ninety (90) days of Allergan's notice of termination, Licensee shall and does hereby, and shall cause its Sublicensees and its and their Affiliates to:", "": "" }, { "Text": "(a) grant Allergan an exclusive, royalty-free, perpetual, worldwide license and right of reference, with the right to grant sublicenses and further rights of reference (through multiple tiers), under all (i) Regulatory Documentation (including any Regulatory Approvals), (ii) Licensee Patents, (iii) Licensee Know-How and (iv) Product Trademarks, in each case ((i) through (iv)) then owned or Controlled by Licensee, to Exploit the Licensed Compound and the Licensed Products, and Licensee shall continue to maintain such Licensee Patents, Licensee Know-How and Product Trademarks at Allergan's expense for reasonable out-of-pocket costs unless and until Allergan notifies Licensee that such maintenance is no longer required; provided that the licenses granted to Allergan in this Section 10.9.2(a) shall be subject to the terms and conditions of the applicable Licensed Product Agreement consented to by Allergan pursuant to Section 3.5. Without limitation of the foregoing, in the event and to the extent any such Licensed Product Agreement requires that particular terms or conditions of such Licensed Product Agreement be contained or incorporated in any agreement granting a sublicense, such terms and conditions are hereby deemed to be incorporated herein by reference and made applicable to the applicable license granted to Allergan pursuant to this Section 10.9.2(a), and Allergan shall be responsible for any payments to Third Parties owed under any such Licensed Product Agreement based on the Exploitation of the Licensed Compound or Licensed Products by Allergan, its Affiliates and (sub)licensees.", "": "" }, { "Text": "(b) unless expressly prohibited by any Regulatory Authority, transfer control to Allergan of all Clinical Trials of each Licensed Product being conducted by or on behalf of Licensee or its Sublicensees or its or their respective Affiliates as of the effective date of such termination and continue to conduct such Clinical Trials, at Allergan's reasonable cost and expense, for up to six months to enable such transfer to be completed without interruption of any such Clinical Trial; provided that (i) Allergan shall not have any obligation to continue any Clinical Trial unless required by Applicable Law and (ii) with respect to each Clinical Trial (A) for which such transfer is expressly prohibited by the applicable Regulatory Authority or (B) that is required for Regulatory Approval that Allergan does not request that Licensee transfer control of such Clinical Trial to Allergan, if any, Licensee shall continue to conduct such Clinical Trial to completion, at Allergan's request and reasonable cost and expense;", "": "" }, { "Text": "(c) except as provided in clause (f) below, assign (or cause its Sublicensees or its or their Affiliates to assign) to Allergan all Licensed Product Agreements to the extent they relate to the Exploitation of the Licensed Products in the Field in the Territory, unless, with respect to any such Licensed Product Agreement, such Licensed Product Agreement expressly prohibits such assignment, in which case Licensee shall cooperate with Allergan in all reasonable respects to secure the consent of the applicable Third Party to such assignment and if any such consent cannot be obtained with respect to a Licensed Product Agreement, Licensee shall use reasonable best efforts to maintain such Licensed Product Agreement in full force and effect and to obtain for Allergan substantially all of the practical benefit and burden under such Licensed Product Agreement, including by (i) entering into appropriate and reasonable alternative arrangements on terms mutually agreeable to Allergan and the applicable Third Party and (ii) subject to the consent and control of Allergan, enforcing, at Allergan's cost and expense and for the account of Allergan, any and all rights of Licensee or its relevant Sublicensee or its or their relevant Affiliate, if applicable, against the other party thereto arising out of the breach or cancellation thereof by such other party or otherwise;", "": "" }, { "Text": "(d) to the extent any Licensed Product Agreements also relate to products of Licensee, a Sublicensee or its or their Affiliates other than the Licensed Products and do not relate to any Licensed Patents, Licensed Know-How, Licensee Patents, Licensee Know-How, Joint Patents or Joint Know-How, assist Allergan with entering into appropriate and reasonable alternative arrangements on terms mutually agreeable to Allergan and the applicable Third Party and until such alternative arrangements are effective, shall maintain such Licensed Product Agreements in full force and effect and obtain for Allergan substantially all of the practical benefit and burden under such Licensed Product Agreements;", "": "" }, { "Text": "(e) provide Allergan with copies of all reports and data generated or obtained by Licensee or any of its Sublicensees or its or their Affiliates that relate to any Licensed Product that have not previously been provided to Allergan;", "": "" }, { "Text": "(f) assign to Allergan all right, title, and interest of Licensee, its Sublicensees and its and their Affiliates in each Product Trademark;", "": "" }, { "Text": "(g) transfer to Allergan such quantities of Licensee's, its Sublicensees' and its and their Affiliates' existing inventory of Licensed Compound or Licensed Products as Allergan requests. The cost to Allergan for such transfer shall be Licensee's actual cost to Manufacture such Licensed Compound and Licensed Products;", "": "" }, { "Text": "(h) to the extent that Licensee has a clinical or commercial source of supply of Licensed Compound and Licensed Product as of the effective date of termination, supply to Allergan such reasonable quantities of the Licensed Compound and Licensed Products as Allergan indicates in written forecasts and orders therefor from time to time until the earlier of (i) such time as Allergan has established an alternate, validated source of supply for the Licensed Compound and Licensed Products, and Allergan is receiving supply from such alternative source and (ii) the 18-month anniversary of the effective date of termination of this Agreement. The cost to Allergan for such supply shall be Licensee's actual cost to Manufacture such Licensed Compound and Licensed Products; and", "": "" }, { "Text": "(i) transfer to Allergan the global safety database for the Licensed Products in the Field in the Territory.", "": "" }, { "Text": "10.9.3 In the event of an early termination (but not expiration) of the Agreement, none of Licensee, its Sublicensees or its or their Affiliates shall have any further right in or to the Licensed Patents and Licensee shall provide such assistance and cooperation with respect to the prosecution, enforcement and defense of such Licensed Patents, at Allergan's cost and expense, as Allergan was required to provide to Licensee during the Term with respect to the Licensed Patents pursuant to the first sentence of Section 6.2.1, the first sentence of Section 6.3.4, the last sentence of Section 6.4.1, and the first sentence of Section 6.5.2, and Allergan shall bear all costs and expenses, and retain all recoveries, with respect to the enforcement of any Licensed Patent.", "": "" }, { "Text": "10.9.4 Without limiting Allergan's rights under other provisions of this ARTICLE 10, in the event of any termination by Allergan pursuant to Section 10.2, Licensee shall, at the request and expense of Allergan, provide Allergan with such assistance as is reasonably necessary to effectuate a smooth and orderly transition of applicable Development, Manufacture and Commercialization activities with respect to the Licensed Products to Allergan or its designee so as to minimize any disruption of such activities. Further, upon Allergan's request, Licensee shall provide such technical assistance, at no cost to Allergan (except for reimbursement of Licensee's direct out of pocket costs therefor), as may reasonably be requested to transfer applicable Manufacturing technology that has been used by or on behalf of Licensee, its Sublicensees and its and their Affiliates in connection with the Manufacture of the Licensed Compound or any Licensed Product.", "": "" }, { "Text": "10.9.5 If Allergan determines that any waiting period expirations or terminations, consents, clearances, waivers, licenses, registrations, permits, authorizations, orders or approvals are needed from any governmental authority in connection with the exercise of its rights in Section 10.9.2, Allergan shall so notify Licensee and each of Allergan and Licensee shall make any and all filings, cooperate with and assist one another and take any other actions in connection therewith.", "": "" }, { "Text": "10.9.6 All Confidential Information of Licensee relating to the Licensed Compound or Licensed Products (or the Exploitation thereof), to the extent they comprise Licensee Know-How, and any Confidential Information included in the Licensed Product Agreements or Regulatory Documentation assigned to Allergan pursuant to this Section 10.9, shall automatically be deemed to become Confidential Information of Allergan; provided that for any such Confidential Information of Licensee that constitutes Licensee Know-How that is not assigned but rather is licensed to Allergan pursuant to Section 10.9.2(a), such Confidential Information shall be the Confidential Information of both Licensee and Allergan and Allergan shall have the right to use and disclose such Confidential Information in the exercise of its rights granted pursuant to Sections 10.9.2(a) or 10.9.2(c), as applicable, and Licensee or its Affiliates may use and disclose such Confidential Information for all other purposes.", "": "" }, { "Text": "10.10 Intentionally Omitted.", "": "" }, { "Text": "10.11 Accrued Rights; Surviving Obligations.", "": "" }, { "Text": "10.11.1Accrued Rights. Termination or expiration of this Agreement for any reason shall be without prejudice to any rights that shall have accrued to the benefit of a Party prior to such termination or expiration. Such termination or expiration shall not relieve a Party from obligations that are expressly indicated to survive the termination or expiration of this Agreement.", "": "" }, { "Text": "10.11.2Survival. Except as expressly set forth herein, all rights and obligations of the Parties shall terminate upon the expiration or termination of this Agreement, as follows:", "": "" }, { "Text": "(a) In the event of an expiration (but not early termination) of this Agreement, Sections 2.1, 2.3, 2.5, 2.9, 2.10, 3.4 (with respect to retention of records maintained during the Term for the period set forth therein), 3.6, 3.8, 4.4, 4.5, 6.1.1, 6.1.2, 6.1.3 (solely with respect to Section 6.1.2), 8.5, 8.6, 10.1 (last sentence), 10.8, 10.11.1, this Section 10.11.2(a), ARTICLE 5 (with respect to sales of Licensed Products and other activities hereunder during the Term, costs and expenses incurred during the Term and Qualifying Sublicense Payments and Disposition Proceeds), ARTICLE 7, ARTICLE 9 (provided, for clarity, that Section 9.6 shall survive for the period set forth therein), and ARTICLE 11 (excluding Section 11.1) and related definitions in ARTICLE 1 shall survive the expiration of this Agreement.", "": "" }, { "Text": "(b) In the event of an early termination (but not expiration) of this Agreement, then effective upon the effective date of such termination, Sections 3.4 (with respect to retention of records maintained during the Term for the period set forth therein), 3.8 (second sentence), 6.1.1 (subject to Section 10.9.2), 6.1.2 (subject to Section 10.9.2), 6.1.3 (solely with respect to Section 6.1.2), 6.2.1 (solely for the benefit of Allergan), 6.3.4 (first sentence only and solely for the benefit of Allergan), 6.5.2 (first sentence only and solely for the benefit of Allergan), 6.7.4 (solely for the benefit of Allergan), 8.5, 8.6, 10.8, 10.9, 10.11.1, this Section 10.11.2(b), ARTICLE 5 (with respect to sales of Licensed Products and other activities hereunder during the Term, costs and expenses incurred during the Term and Qualifying Sublicense Payments and Disposition Proceeds), ARTICLE 7, ARTICLE 9 (provided, for clarity, that Section 9.6 shall survive for the period set forth therein), and ARTICLE 11 (excluding Section 11.1) and related definitions in ARTICLE 1 shall survive termination of this Agreement.", "": "" }, { "Text": "ARTICLE 11 MISCELLANEOUS", "": "" }, { "Text": "11.1 Force Majeure. Neither Party shall be held liable or responsible to the other Party or be deemed to have defaulted under or breached this Agreement for failure or delay in fulfilling or performing any term of this Agreement (other than an obligation to make payments) to the extent such failure or delay is caused by or results from events beyond the reasonable control of the non-performing Party, including fires, floods, earthquakes, embargoes, shortages, epidemics, quarantines, war, acts of war (whether war be declared or not), terrorist acts, insurrections, riots, civil commotion, strikes, lockouts or other labor disturbances (whether involving the workforce of the non-performing Party or of any other Person), acts of God or acts, omissions or delays in acting by any governmental authority (each, a \"Force Majeure Event\"). The non-performing Party shall notify the other Party in writing of a Force Majeure Event within 10 days after the occurrence of such Force Majeure Event, which notice shall include the nature of such Force Majeure Event, its anticipated duration, and any action being taken to avoid or minimize its effect. The suspension of performance shall be of no greater scope and no longer duration than is necessary and the non-performing Party shall use commercially reasonable efforts to remedy its inability to perform. In the event that such suspension of performance lasts for more than 90 days and in the absence of such Force Majeure Event such suspension of performance would be a material breach of this Agreement, such other Party shall have the right to terminate this Agreement pursuant to Section 10.2.", "": "" }, { "Text": "11.2 Intentionally Omitted.", "": "" }, { "Text": "11.3 Export Control. This Agreement is made subject to any restrictions concerning the export of products or technical information from the United States or other countries that may be imposed on or related to the Parties from time to time. Each Party agrees that it will not export, directly or indirectly, any technical information acquired from the other Party under this Agreement or any products using such technical information to a location or in a manner that at the time of export requires an export license or other governmental approval, without first obtaining the written consent to do so from the appropriate agency or other governmental entity in accordance with Applicable Law.", "": "" }, { "Text": "11.4 Assignment. Without the prior written consent of the other Party, neither Party shall sell, transfer, assign, delegate, pledge or otherwise dispose of, whether voluntarily, involuntarily, by operation of law or otherwise, this Agreement or any of its rights or duties hereunder; provided that (a) Allergan may, without such consent, assign this Agreement and its rights and obligations hereunder to an Affiliate, to its successor entity or acquirer in the event of a merger, consolidation or change in control of Allergan, or to any Person who acquires any rights or interests in or to the Licensed Know-How or the Licensed Patents, (b) Licensee may, without Allergan's consent, assign this Agreement to the applicable acquiror, surviving entity or other successor in a Change of Control, and (c) Licensee may, without Allergan's consent, assign this Agreement and its rights and obligations to an Affiliate; provided, that (i) in the case of the first assignment by Licensee involving a Change of Control, Licensee shall have complied with Section 5.3.3, and (ii) with respect to any assignment by Allergan or Licensee to an Affiliate, such assigning Party shall remain responsible for the performance by such Affiliate of the assigning Party's obligations hereunder. Any attempted assignment or delegation in violation of the preceding sentence shall be void and of no effect. All validly assigned and delegated rights and obligations of the Parties hereunder shall be binding upon and inure to the benefit of and be enforceable by and against the successors and permitted assigns of Allergan or Licensee, as the case may be. In the event either Party assigns or delegates its rights or obligations to another Person in accordance with this Section 11.4 (other than to an Affiliate), the assignee or transferee shall assume all obligations of its assignor or transferor under this Agreement.", "": "" }, { "Text": "11.5 Severability. To the fullest extent permitted by Applicable Law, the Parties waive any provision of law that would render any provision in this Agreement invalid, illegal, or unenforceable in any respect. If any provision of this Agreement is held to be invalid, illegal, or unenforceable, in any respect, then such provision will be given no effect by the Parties and shall not form part of this Agreement. To the fullest extent permitted by Applicable Law and if the rights or obligations of either Party will not be materially and adversely affected, all other provisions of this Agreement shall remain in full force and effect, and the Parties shall use their best efforts to negotiate a provision in replacement of the provision held invalid, illegal, or unenforceable that is consistent with Applicable Law and achieves, as nearly as possible, the original intention of the Parties.", "": "" }, { "Text": "11.6 Dispute Resolution.", "": "" }, { "Text": "11.6.1 If a dispute arises between the Parties in connection with the interpretation, validity or performance of this Agreement or any document or instrument delivered in connection herewith, other than a dispute arising under the second to last sentence of Section 5.3.3 or a dispute governed by Section 5.10 (a \"Dispute\"), then either Party shall have the right to refer such dispute to the Executive Officers for attempted resolution by good faith negotiations during a period of 10 Business Days. Any final decision mutually agreed to by the Executive Officers in writing shall be conclusive and binding on the Parties. If such Executive Officers are unable to resolve such Dispute within such 10-Business Day period, either Party shall be free to institute litigation in accordance with Section 11.7 and seek such remedies as may be available. Notwithstanding anything in this Agreement to the contrary, either Party shall be entitled to institute litigation in accordance with Section 11.7 immediately if litigation is necessary to prevent irreparable harm to that Party.", "": "" }, { "Text": "11.7 Governing Law and Service.", "": "" }, { "Text": "11.7.1 Governing Law. This Agreement shall be governed by and construed in accordance with the laws of New York, excluding any conflicts or choice of law rule or principle that might otherwise refer construction or interpretation of this Agreement to the substantive law of another jurisdiction.", "": "" }, { "Text": "11.7.2 Jurisdiction. Subject to Section 11.6 and Section 11.11, the Parties hereby irrevocably and unconditionally consent to the exclusive jurisdiction of the courts of the State of New York (or federal courts sitting in such state) for any action, suit or proceeding (other than appeals therefrom) arising out of or relating to this Agreement, and agree not to commence any action, suit or proceeding (other than appeals therefrom) related thereto except in such courts. The Parties irrevocably and unconditionally waive their right to a jury trial.", "": "" }, { "Text": "11.7.3 Service. Each Party further agrees that service of any process, summons, notice or document by registered mail to its address set forth in Section 11.8.2 shall be effective service of process for any action, suit or proceeding brought against it under this Agreement in any such court.", "": "" }, { "Text": "11.8 Notices.", "": "" }, { "Text": "11.8.1 Notice Requirements. Any notice, request, demand, waiver, consent, approval or other communication permitted or required under this Agreement shall be in writing, shall refer specifically to this Agreement and shall be deemed given only if delivered by hand or sent by facsimile transmission (with transmission confirmed) or by internationally recognized overnight delivery service that maintains records of delivery, addressed to the Parties at their respective addresses specified in Section 11.8.2 or to such other address as the Party to whom notice is to be given may have provided to the other Party in accordance with this Section 11.8. Such notice shall be deemed to have been given as of the date delivered by hand or transmitted by facsimile (with transmission confirmed) or on the third Business Day (at the place of delivery) after deposit with an internationally recognized overnight delivery service. Any notice delivered by facsimile shall be confirmed by a hard copy delivered as soon as practicable thereafter. This Section 11.8 is not intended to govern the day-to-day business communications necessary between the Parties in performing their obligations under the terms of this Agreement.", "": "" }, { "Text": "11.8.2 Addresses for Notice.", "": "" }, { "Text": "If to Licensee, to:", "": "" }, { "Text": "FSV7, LLC", "": "" }, { "Text": "1000 Marina Blvd, Suite 105", "": "" }, { "Text": "Brisbane, CA 94005", "": "" }, { "Text": "Attention: CEO", "": "" }, { "Text": "Facsimile: 603-676-6905", "": "" }, { "Text": "with a copy to (which shall not constitute notice):", "": "" }, { "Text": "Wilson Sonsini Goodrich & Rosati", "": "" }, { "Text": "28 State Street, 37th Floor", "": "" }, { "Text": "Boston, MA 02109", "": "" }, { "Text": "Attention: Farah B. Gerdes", "": "" }, { "Text": "Facsimile: 866-974-7329", "": "" }, { "Text": "If to Allergan, to:", "": "" }, { "Text": "5 Giralda Farms", "": "" }, { "Text": "Madison, NJ 07940", "": "" }, { "Text": "Attention: President", "": "" }, { "Text": "Facsimile: 862-261-8253", "": "" }, { "Text": "with a copy to (which shall not constitute notice):", "": "" }, { "Text": "Covington & Burling LLP", "": "" }, { "Text": "One CityCenter", "": "" }, { "Text": "850 Tenth Street, NW", "": "" }, { "Text": "Washington, DC 20001", "": "" }, { "Text": "Attention: John A. Hurvitz", "": "" }, { "Text": "Facsimile: [•]", "": "" }, { "Text": "11.9 Entire Agreement; Amendments. This Agreement, together with the Schedules attached hereto, sets forth and constitutes the entire agreement and understanding between the Parties with respect to the subject matter hereof and all prior agreements, understandings, promises and representations, whether written or oral, with respect thereto are superseded hereby, including the Prior CDA. Without limiting the foregoing, this Agreement shall amend, restate and supersede in its entirety, the Original License Agreement, effective as of the Effective Date. Each Party confirms that it is not relying on any representations or warranties of the other Party except as specifically set forth herein. No amendment, modification, release or discharge shall be binding upon the Parties unless in writing and duly executed by authorized representatives of both Parties.", "": "" }, { "Text": "11.10 English Language. This Agreement shall be written and executed in, and all other communications under or in connection with this Agreement shall be in, the English language. Any translation into any other language shall not be an official version thereof, and in the event of any conflict in interpretation between the English version and such translation, the English version shall control.", "": "" }, { "Text": "11.11 Equitable Relief. The Parties acknowledge and agree that the restrictions set forth in ARTICLE 7 are reasonable and necessary to protect the legitimate interests of the other Party and that such other Party would not have entered into this Agreement in the absence of such restrictions, and that any breach or threatened breach of any provision of ARTICLE 7 may result in irreparable injury to such other Party for which there will be no adequate remedy at law. In the event of a breach or threatened breach of any provision of ARTICLE 7, the non-breaching Party shall be authorized and entitled to obtain from any court of competent jurisdiction injunctive relief, whether preliminary or permanent, specific performance and an equitable accounting of all earnings, profits and other benefits arising from such breach, which rights shall be cumulative and in addition to any other rights or remedies to which such non-breaching Party may be entitled in law or equity. Each Party hereby waives any requirement that the other Party (a) post a bond or other security as a condition for obtaining any such relief or (b) show irreparable harm, balancing of harms, consideration of the public interest or inadequacy of monetary damages as a remedy. Nothing in this Section 11.11 is intended, or should be construed, to limit either Party's right to equitable relief or any other remedy for a breach of any other provision of this Agreement.", "": "" }, { "Text": "11.12 Waiver and Non-Exclusion of Remedies. Any term or condition of this Agreement may be waived at any time by the Party that is entitled to the benefit thereof, but no such waiver shall be effective unless set forth in a written instrument duly executed by or on behalf of the Party waiving such term or condition. The waiver by either Party of any right hereunder or of the failure to perform or of a breach by the other Party shall not be deemed a waiver of any other right hereunder or of any other breach or failure by the other Party whether of a similar nature or otherwise.", "": "" }, { "Text": "11.13 No Benefit to Third Parties. The representations, warranties, covenants and agreements set forth in this Agreement are for the sole benefit of the Parties and their successors and permitted assigns, and they shall not be construed as conferring any rights on any other Persons.", "": "" }, { "Text": "11.14 Further Assurance. Each Party shall duly execute and deliver, or cause to be duly executed and delivered, such further instruments and do and cause to be done such further acts and things, including the filing of such assignments, agreements, documents and instruments, as may be necessary or as the other Party may reasonably request in connection with this Agreement or to carry out more effectively the provisions and purposes hereof, or to better assure and confirm unto such other Party its rights and remedies under this Agreement.", "": "" }, { "Text": "11.15 Relationship of the Parties. It is expressly agreed that Allergan, on the one hand, and Licensee, on the other hand, shall be independent contractors and that the relationship between the two Parties shall not constitute a partnership, joint venture or agency. Neither Allergan, on the one hand, nor Licensee, on the other hand, shall have the authority to make any statements, representations or commitments of any kind, or to take any action, which shall be binding on the other, without the prior written consent of the other Party to do so, such consent not to be unreasonably conditioned, withheld or delayed. All persons employed by a Party shall be employees of such Party and not of the other Party and all costs, expenses and obligations incurred by reason of any such employment shall be for the account and expense of such Party.", "": "" }, { "Text": "11.16 Counterparts. This Agreement may be executed in any number of counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. This Agreement may be executed by facsimile or other electronic signatures and such signatures shall be deemed to bind each Party as if they were original signatures.", "": "" }, { "Text": "11.17 References. Unless otherwise specified, (a) references in this Agreement to any Article, Section or Schedule means references to such Article, Section or Schedule of this Agreement, (b) references in any section to any clause are references to such clause of such section and (c) references to any agreement, instrument or other document in this Agreement refer to such agreement, instrument or other document as originally executed or, if subsequently varied, replaced or supplemented from time to time, as so varied, replaced or supplemented and in effect at the relevant time of reference thereto.", "": "" }, { "Text": "11.18 Construction. Except where the context otherwise requires, wherever used, the singular shall include the plural, the plural the singular, the use of any gender shall be applicable to all genders and the word \"or\" is used in the inclusive sense (and/or). The captions of this Agreement are for convenience of reference only and in no way define, describe, extend or limit the scope or intent of this Agreement or the intent of any provision contained in this Agreement. The term \"including\" as used herein means including, without limiting the generality of any description preceding such term. The language of this Agreement shall be deemed to be the language mutually chosen by the Parties and no rule of strict construction shall be applied against either Party.", "": "" }, { "Text": "[SIGNATURE PAGE FOLLOWS.]", "": "" }, { "Text": "Schedule 1.6 Allergan Agreements", "": "" }, { "Text": "1. Amended and Restated Collaboration Agreement, dated as of December 20, 2007, between Diaxonhit (as successor to ExonHit Therapeutics SA) and Allergan Sales, LLC, as amended on (a) December 23, 2008 pursuant to the First Amendment to Amended and Restated Collaboration Agreement, (b) March 1, 2010 pursuant to the Second Amendment to Amended and Restated Collaboration Agreement and the Assignment Agreement, (c) March 2, 2010 pursuant to the Third Amendment to Amended and Restated Collaboration Agreement, (d) September 16, 2011 pursuant to the Fourth Amendment to Amended and Restated Collaboration Agreement, (e) December 20, 2013 pursuant to the Fifth Amendment to Amended and Restated Collaboration Agreement and (f) July 30, 2015 pursuant to the Termination Agreement.", "": "" }, { "Text": "Schedule 1.60", "": "" }, { "Text": "Allergan Employees", "": "" }, { "Text": "1. John Donello", "": "" }, { "Text": "2. Brandon Ponichter", "": "" }, { "Text": "3. Andrew Stewart", "": "" }, { "Text": "Schedule 1.64", "": "" }, { "Text": "Licensed Patents", "": "" }, { "Text": "[Table of patents omitted for brevity]", "": "" }, { "Text": "Schedule 2.7.1 Technology Disclosures", "": "" }, { "Text": "1. Pre-clinical reports generated by Allergan or a Third Party", "": "" }, { "Text": "2. IND enabling reports generated by Allergan or a Third Party", "": "" }, { "Text": "3. Clinical study plans and reports generated by Allergan or a Third Party", "": "" }, { "Text": "4. All IND applications filed by Allergan or a Third Party and related rights thereto", "": "" }, { "Text": "5. Manufactured API with relevant quality and stability reports", "": "" }, { "Text": "6. Information on API method of storage", "": "" }, { "Text": "7. Pharmaceutical Research, Development and Manufacturing report", "": "" }, { "Text": "7.1. Chemistry, Manufacturing and Control (CMC)/Product Specification Files", "": "" }, { "Text": "7.1.1. Historical data of pharmaceutical development of new drug substance and drug products at stages from early development phase to final API", "": "" }, { "Text": "7.1.2. Specifications and Standard Test Procedures of drug substances, intermediates, drug products, raw materials, and components, and their rationale (validation of specification range of important tests such as contents, impurities and dissolution, rationale for selection of the test methods, reagents, and columns, and traceability of raw data of those information)", "": "" }, { "Text": "7.1.3. Drug Master File", "": "" }, { "Text": "8. List of sub-contractors and suppliers used to support pre-clinical, IND, clinical, and manufacturing activities", "": "" }, { "Text": "9. Global safety database for the Licensed Products in the Field in the Territory", "": "" }, { "Text": "Schedule 2.7.2 Transferred Compounds", "": "" }, { "Text": "[to be provided]", "": "" }, { "Text": "Schedule 3.2", "": "" }, { "Text": "FDA Letters", "": "" }, { "Text": "[To be provided]", "": "" } ]