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6.1.8 review and discuss Calibr's Development activities with respect to products containing Calibr Components Directed to any Existing Target; |
6.1.9 review and discuss AbbVie's Development activities with respect to the Licensed Products; |
6.1.10 review and discuss the Manufacturing of the Licensed Products; and |
6.1.11 perform such other functions as are set forth herein, if and as applicable, or as the Parties may mutually agree in writing. |
6.2 CD19 Platform Proof-of-Principle Joint Development Committee. Within fifteen (15) days after the Original Effective Date, the Parties shall establish a CD19 joint development committee (the "CD19-JDC"), which shall consist of three (3) representatives from each Party, each with the requisite experience and seniorit... |
6.2.1 review and approve any amendments or updates to the CD19 Plan; |
6.2.2 direct and supervise Calibr's Development activities under the CD19 Plan (including clinical and regulatory decisions with respect thereto) and review Calibr's progress against the CD19 Plan; |
6.2.3 review and discuss AbbVie's Development activities with respect to the CD19 Licensed Products after AbbVie exercises the CD19 License Option; |
6.2.4 review and discuss the Manufacturing of the CD19 Products under the CD19 Plan; |
6.2.5 discuss the utility in conducting ongoing stability studies for existing stored drug product based on AbbVie's then-current non-binding position regarding whether it intends to exercise the CD19 Autoimmune Option; and |
6.2.6 perform such other functions as are set forth herein, if and as applicable, or as the Parties may mutually agree in writing. |
6.3 General Provisions Applicable to a Committee. |
6.3.1 Meetings and Minutes. The TD-JRC and CD19-JDC (each, a "Committee") shall each meet quarterly or as otherwise agreed to by the Parties, with the location of in-person meetings alternating between a location designated by Calibr and a location designated by AbbVie, with AbbVie designating the place of the first me... |
6.3.2 Procedural Rules. Each Committee 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 each Committee shall exist whenever there is present at a meeting at least one (1) representative appointed by ... |
6.3.3 Limitations on Authority. Without limitation to the foregoing, each Party hereby agrees that 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 any Committee, includi... |
6.3.4 Discontinuation; Disbandment. Each Committee shall continue to exist until the first to occur of: (a) the Parties mutually agreeing to disband such Committee, (b) AbbVie's request if AbbVie exercises the Platform Option, (c) upon AbbVie's request after the First Commercial Sale of the first (1st) Licensed Product... |
6.4 Decision-Making. Subject to the following provisions of this Section 6.4, 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 writte... |
6.4.1 TD-JRC Final Decision Making Authority. With respect to issues within the jurisdiction of the TD-JRC, (a) for issues other than a Deadlocked Dispute or any dispute described in clause (b), AbbVie shall have final decision-making authority, (b) for issues regarding amendments to the Platform Improvement Plan that ... |
6.4.2 CD19-JDC Final Decision Making Authority. With respect to issues within the jurisdiction of the CD19-JDC, Calibr shall have final decision-making authority; provided, that: (a) the CD19-JDC shall approve the Initial CD19 Autoimmune Subplan as an amendment to the CD19 Plan upon AbbVie's exercise of the CD19 Autoim... |
6.5 Working Groups. From time to time, either Committee may establish and delegate duties within the scope of authority of such Committee 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... |
6.6 Alliance Managers. Each Party shall appoint an individual who shall oversee contact between the Parties for all matters between meetings of the Committees and shall have such other responsibilities as the Parties may agree in writing after the Original Effective Date, which individual may be replaced at any time by... |
ARTICLE 7 PAYMENTS AND RECORDS |
7.1 Upfront Payments. Subject to the terms and conditions of this Agreement, no later than thirty (30) days after the Original Effective Date, AbbVie shall pay Calibr in consideration of the licenses and license options granted by Calibr to AbbVie hereunder a non-creditable, non-refundable payment of Fifty-Five Million... |
7.2 Platform Option Extension Fee. Subject to the terms and conditions of this Agreement, no later than thirty (30) days after the A&R Effective Date, AbbVie shall pay Calibr in consideration of the licenses and license options granted by Calibr to AbbVie hereunder a non-creditable, non-refundable payment of Forty-Four... |
7.3 Platform Extension Payment. If AbbVie provides written notice to Calibr in accordance with Section 3.2.2 at least ninety (90) days before the fifth (5th) anniversary of the A&R Effective Date of its desire to extend the New Platform Exclusivity Period by twelve (12) months, then AbbVie shall pay to Calibr within th... |
7.4 CD19 Autoimmune Option Fee. Within thirty (30) days after the CD19-JDC approves an amendment to the CD19 Plan to include the Initial CD19 Autoimmune Subplan in accordance with Section 2.2.2, AbbVie shall pay to Calibr, as partial consideration for the rights granted under this Agreement with respect to the CD19 Aut... |
7.5 Non-Platform Option Milestones. |
7.5.1 Research Target Milestones and CD19 Milestones. Unless and until AbbVie exercises the Platform Option, AbbVie shall make the following one-time milestone payments (each, a "Milestone Payment") to Calibr upon first achievement of the corresponding milestone events (each, a "Milestone Event") listed below. AbbVie s... |
[MILESTONE TABLE CONTENT APPEARS TO BE MISSING] |
7.5.2 Sales Milestones. On a Licensed Product-by-Licensed Product basis, unless AbbVie has exercised the Platform Option, AbbVie shall pay to Calibr a one-time, non-refundable, non-creditable milestone payment within forty five (45) days after the end of the Calendar Quarter in which worldwide annual Net Sales of a Lic... |
[SALES MILESTONE TABLE CONTENT APPEARS TO BE MISSING] |
7.5.3 Skipped Milestone Events. If a Milestone Event happens for a Licensed Product but such Licensed Product has not previously achieved all earlier Milestone Events (such as when a clinical development program does not include a Phase I Clinical Trial or Phase II Clinical Trial in a conventional progression or a Mile... |
7.6 Royalties. |
7.6.1 Royalty Rates. Subject to the remainder of this Section 7.6, and unless AbbVie has exercised the Platform Option, AbbVie shall pay to Calibr a royalty on annual (Calendar Year) aggregate Net Sales of each Licensed Product that is not a Cost-Share Product in the Territory during the applicable Royalty Term for suc... |
using such Licensed Product (or any Calibr Component included in such Licensed Product), which method covers an indication for which such Licensed Product has received Regulatory Approval in such country or (II) a method of making such Licensed Product (or any Calibr Component included in such Licensed Product), for co... |
(b) if in any country in the Territory during the Royalty Term in such country for a Licensed Product, a Biosimilar Product with respect to such Licensed Product is launched in such country, then; (i) starting with the Calendar Quarter in which unit sales of all Biosimilar Products for such Licensed Product in such cou... |
(c) except as otherwise provided in Section 7.6.4(d), if AbbVie enters into a Third Party Agreement in order to obtain a license or other right to a Third Party Right with respect to a Licensed Product in one (1) or more countries in the Territory pursuant to Section 8.9, other than any Third Party Rights with respect ... |
(d) if AbbVie enters into a Third Party Agreement in order to obtain a license or other right to a Third Party Right with respect to a Licensed Product in one (1) or more countries in the Territory pursuant to Section 8.9 that is necessary to avoid infringing or misappropriating a Patent, trade secret or other intellec... |
(e) if, during the Royalty Term for a Licensed Product, such Licensed Product is designated as a "selected drug" by the Secretary of the U.S. Department of Health and Human Services (in accordance with Section 1192(a) of the Social Security Act), and AbbVie is required to negotiate a maximum fair price (as defined in S... |
(f) AbbVie shall be entitled to the deductions set forth in Section 8.8.4, if applicable. |
Any reductions set forth in Section 7.6.4 shall be applied to the royalty rate payable to Calibr under Section 7.6.1, Section 7.6.2 or Section 7.7, as applicable, in the order in which the event triggering such reduction occurs. For purposes of this Section 7.6, the portion of Net Sales of a Licensed Product in each co... |
7.6.5 Cap on Reductions. In no event shall the royalty rate payable to Calibr under Section 7.6.1 or Section 7.6.2, as applicable, for a particular Licensed Product be reduced by more than fifty percent (50%) of what it would otherwise be in any Calendar Quarter as a result of the reductions set forth in Section 7.6.4(... |
7.13 Taxes. |
7.13.1 Withholding Taxes. If any amount to be paid to either Party hereunder is subject to any withholding or similar tax, 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 take advantage of (a) any applicable double taxation... |
7.13.2 Indirect Taxes. All payments 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 payments, the payor Party shall pay such Indirect Taxes at the applicable rate in respect of such payments followi... |
7.13.3 Changes in Domicile. Notwithstanding anything to the contrary in this Agreement, if the payor Party assigns, transfers or otherwise disposes of some or all of its rights and obligations to any Person and if, as a result of such action, the withholding or deduction of tax required by Applicable Laws with respect ... |
7.14 Interest on Late Payments. If any payment due to either Party under this Agreement is not paid when due, then the payor Party with respect thereto shall pay interest thereon (before and after any judgment) at a rate (with interest accruing on a daily basis) equal to the lesser of: (a) two hundred (200) basis point... |
7.15 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, and Calibr shall, and shall cause its Affiliates and its and their (sub)licensees to, keep complete and accurate financial books and rec... |
7.16 Audit. |
7.16.1 Procedures. At the request of the other Party, each Party shall, and shall cause its Affiliates and its and their (sub)licensees to, permit an independent auditor designated by the other Party and reasonably acceptable to the audited Party, at reasonable times and upon reasonable notice, to audit the books and r... |
7.16.2 Audit Dispute. In the event of a dispute with respect to any audit under Section 7.16.1, the Parties 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 thirty (30) days after one Party notifies the other Party of such di... |
7.16.3 Confidentiality. The Receiving Party shall treat all information subject to review under this Article 7 in accordance with the confidentiality provisions of Article 9. The audited Party shall not be obligated to provide any information to the independent auditor pursuant to Section 7.16.1 or the Auditor pursuant... |
7.17 Right to Offset. Each Party shall have the right to offset any (a) undisputed amount or (b) disputed amount once such dispute has been finally resolved pursuant to Section 13.5, in each case ((a) and (b)), owed by the other Party to such first Party under or in connection with this Agreement, including pursuant to... |
7.18 Diagnostic or Veterinary Products. The royalties in Section 7.6 or Section 7.7 shall 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 el... |
7.19 Financial Obligations under In-License Agreements. Unless otherwise agreed by the Parties, Calibr shall be responsible for all payments owed to Third Parties under the In-License Agreements or any other agreement (including funding agreements) to which it is a Party. |
ARTICLE 8 INTELLECTUAL PROPERTY |
8.1 Ownership of Intellectual Property. |
8.1.1 Ownership of IP. Subject to the license grants and other rights herein, including Calibr's assignment obligation under Section 8.1.3, as between the Parties, each Party shall own and retain all right, title and interest in and to any and all Information and inventions that are conceived, discovered, developed or ... |
8.1.2 Ownership of Joint IP. Subject to Section 8.1.3, as between the Parties, the Parties shall each own an equal, undivided interest in any and all: (a) Information and inventions that are conceived, discovered, developed or otherwise made under this Agreement jointly by or on behalf of Calibr or its Affiliates or it... |
8.1.3 Exceptions. Notwithstanding Section 8.1.1 and 8.1.2, as between the Parties, AbbVie shall own and retain all right, title and interest in and to any and all Information and inventions that are conceived, discovered, developed or otherwise made or acquired by or on behalf of either Party (or its Affiliates or its ... |
8.1.4 United States Law. The determination of whether Information and inventions are conceived, discovered, developed or otherwise made by 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 ... |
8.1.5 Assignment Obligation. Each Party shall cause all Persons who perform Development activities, Manufacturing activities, Commercialization activities or regulatory activities for such Party under this Agreement or who conceive, discover, develop or otherwise make any Information or inventions by or on behalf of su... |
8.2 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, Patent ... |
8.3 Maintenance and Prosecution of Patents. |
8.3.1 Patent Prosecution and Maintenance of Joint Patents and Product Patents. As between the Parties, AbbVie shall have the first right, but not the obligation, using counsel of its own choice, to prepare, file, prosecute and maintain the Joint Patents and any Product Patent worldwide and to be responsible for any rel... |
8.3.2 Patent Prosecution and Maintenance of Calibr Patents Other Than Product Patents. Subject to the remainder of this Section 8.3.2, as between the Parties, Calibr shall have the sole right, but not the obligation, to prepare, file, prosecute and maintain the Calibr Patents (except those Calibr Patents that constitut... |
(a) With respect to Patents Controlled by Calibr or any of its Affiliates as of the Original Execution Date or at any time during the Term that are not Product Patents and are reasonably necessary or useful for the Exploitation of any products comprising sCAR-Ts, vectors encoding the chimeric proteins expressed by sCAR... |
(b) With respect to Patents Controlled by Calibr or any of its Affiliates as of the Original Execution Date or at any time during the Term that are not Product Patents and are reasonably necessary or useful for the Exploitation of any CD19 Products ("Calibr CD19 Patents"), (i) prior to AbbVie's exercise of the CD19 Lic... |
(c) While Calibr is the prosecuting Party for any Option Patents, Calibr shall periodically inform AbbVie of all material steps with regard to the preparation, filing, prosecution and maintenance of such Option Patents in the Territory, including by providing AbbVie with a copy of material communications to and from th... |
(d) Calibr shall use best efforts to ensure that any Calibr Patents being prepared, filed, prosecuted or maintained by Calibr are not Mixed Patents. Without limiting the foregoing, promptly after the Inclusion Date for a Target with respect to Licensed Products Directed to such Target or the Option Effective Date for t... |
(i) At AbbVie's request, Calibr shall instruct patent counsel for the Mixed Patents to, with respect to any substantive filings or responses with respect to any Mixed Patent, allow AbbVie or AbbVie's counsel to prepare the first draft of any portion thereof that is related to the Licensed Products or the Exploitation t... |
(ii) Calibr shall reasonably consider and not unreasonably reject the requests or suggestions of AbbVie with respect to (A) material communications to and from any patent authority regarding the Mixed Patents to the extent applicable to or potentially affecting claims relating to Licensed Products or the Exploitation t... |
(iii) If Calibr decides not to prepare, file, prosecute or maintain a Mixed Patent in a country, Calibr shall provide reasonable prior written notice to AbbVie of such intention (which notice shall, in any event, be given no later than thirty (30) days prior to the next deadline for any action that may be taken with re... |
8.3.3 Patent Prosecution and Maintenance of AbbVie Patents. As between the Parties, AbbVie shall have the sole right, but not the obligation, to prepare, file, prosecute and maintain all AbbVie Patents worldwide, and to be responsible for any related interference, re-issuance, re-examination, opposition and post-grant ... |
8.3.4 UPC Opt-Out and Opt-In under the UPC. As between the Parties, the Party with the right to prosecute any Patent under this Agreement (the "Prosecuting Party") shall have the sole right to make decisions regarding the Opt-Out or Opt-In under the UPC with respect to such Patent. If the Prosecuting Party wishes to Op... |
8.3.5 Cooperation. With respect to Joint Patents, Product Patents, Mixed Patents, Option Patents (until the CD19 License Option or Platform Option, as applicable, expires without exercise by AbbVie), the non-Prosecuting Party shall, and shall cause its Affiliates to, assist and cooperate with the Prosecuting Party, as ... |
8.3.6 Patent Term Extension and Supplementary Protection Certificate. As between the Parties, with respect to each Licensed Product, AbbVie shall have the sole right to make decisions regarding, and to apply for, patent term extensions worldwide, including the United States with respect to extensions pursuant to 35 U.S... |
8.3.7 Patent Listings. As between the Parties, with respect to each Licensed Product, AbbVie shall have the sole right to make all filings with Regulatory Authorities in the Territory, including as required or allowed (a) in the United States, in the FDA's Orange Book and (b) other international equivalents. With respe... |
8.4 Enforcement of Patents. |
8.4.1 Notice. Each Party shall promptly notify the other Party in writing of any alleged or threatened infringement of AbbVie Patents, Calibr Patents, or Joint Patents in any jurisdiction in the Territory of which such Party becomes aware in connection with the Exploitation of any Licensed Product or any product that c... |
8.4.2 Enforcement of Joint Patents, Product Patents, and Mixed Patents. |
(a) As between the Parties, AbbVie shall have the first right, but not the obligation, to prosecute any Infringement with respect to the Joint Patents and Product Patents, including as a defense or counterclaim in connection with any Third Party Infringement Claim, at AbbVie's sole cost and expense, using counsel of it... |
(b) With respect to any Infringement of a Mixed Patent by a Third Party, AbbVie shall have the first right, but not the obligation, to prosecute any Infringement with respect to any claim in such Mixed Patent that such Third Party infringes if AbbVie reasonably determines in good faith after consultation with Calibr an... |
(c) Subject to Section 8.4.3, if AbbVie prosecutes any such Infringement, Calibr shall have the right, but not the obligation, to join as a party to such claim, suit or proceeding in the Territory and participate with its own counsel at its sole cost and expense; provided, that AbbVie shall retain control of the prosec... |
8.4.3 Cooperation. The Parties agree to cooperate fully in any Infringement action pursuant to Section 8.4.2, including by making the inventors, applicable records and documents (including laboratory notebooks) of the relevant Patents available to the Party prosecuting such Infringement action upon such prosecuting Par... |
8.4.4 Recovery. Except as otherwise agreed by the Parties in connection with a cost sharing arrangement, any recovery realized as a result of any Infringement litigation pursuant to this Section 8.4 (whether by way of settlement or otherwise) shall be first allocated to reimburse the Parties for their costs and expense... |
8.4.5 Obligations for Option Patents. Until the CD19 License Option or Platform Option, as applicable, expires without exercise by AbbVie, Calibr shall use reasonable efforts to prosecute any Infringement of the Option Patents, including as a defense or counterclaim in connection with any Third Party Infringement Claim... |
8.5 Biosimilar Applicants. |
8.5.1 Notice. Notwithstanding the foregoing, if either Party receives notice or a copy of an application submitted to the FDA or another Regulatory Authority for a Biosimilar Product (a "Biosimilar Application") for which a Licensed Product is a reference product, whether or not such notice or copy is provided under an... |
8.5.2 Cooperation. If permitted pursuant to Applicable Law, upon AbbVie's request, Calibr shall assist AbbVie in identifying and listing any Patents as required pursuant to Section 351(l)(1)(3)(A) or Section 351(l)(7) of the PHSA, in negotiating with the filer of the Biosimilar Application pursuant to Section 351(l)(4)... |
8.5.3 Agreed Principles for Biosimilar Products. The Parties recognize that procedures other than those set forth above may apply with respect to applications for Biosimilar Products. If the Parties determine that certain provisions of Applicable Law in the United States or in any other country in the Territory apply t... |
8.5.4 Notwithstanding any other provisions contained herein, AbbVie shall be responsible for managing all aspects of any litigation with respect to Biosimilar Products, including any invalidity or unenforceability defense in courts or before patent offices in connection with such litigation. |
8.6 Enforcement of a Party's Patents. |
8.6.1 Calibr Patents. As between the Parties, Calibr shall have the sole right, but not the obligation, to prosecute Infringement with respect to the Calibr Patents, except those Calibr Patents that constitute (a) Product Patents, (b) Option Patents or (c) Mixed Patents subject to Section 8.4.2, including as a defense ... |
8.6.2 AbbVie Patents. As between the Parties, AbbVie shall have the sole right, but not the obligation, to prosecute Infringement with respect to AbbVie Patents, including as a defense or counterclaim in connection with any Third Party Infringement Claim, at AbbVie's sole cost and expense, using counsel of its own choi... |
8.7 Invalidity or Unenforceability Defenses or Actions. |
8.7.1 Responsibility for Defense. As between the Parties, (a) AbbVie shall have the first right, but not the obligation, to defend (including the right to settle) and control the defense of the validity and enforceability of the Joint Patents and the Product Patents, (b) AbbVie shall have the sole right, but not the ob... |
8.7.2 Cooperation. If a Party defends a Joint Patent, Product Patent, Mixed Patent, or Option Patent, the other Party shall, and shall cause its Affiliates to, assist and cooperate with the defending Party, as such defending Party may reasonably request from time to time in connection with its activities set forth in t... |
8.8 Infringement Claims by Third Parties. |
8.8.1 Notice. If the Exploitation of a Licensed Product, including any Calibr Component, in the Territory pursuant to this Agreement results in, or is reasonably expected to result in, any claim, suit or proceeding by a Third Party alleging infringement by AbbVie or any of its Affiliates or any of its or their Sublicen... |
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