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14.4.1 the royalties payable by AbbVie to Capsida pursuant to Section 9.6 with respect to any Net Sales with respect to the applicable Program(s) after the Modification Date shall be equal to fifty percent (50%) of the applicable rate; |
14.4.2 if AbbVie has the right to terminate this Agreement in its entirety or with respect to the Neurology Program, the amount of any Milestone Payments payable by AbbVie to Capsida pursuant to Section 9.4 for any Milestone Event achieved after the Modification Date shall be reduced by fifty percent (50%) of the appli... |
14.4.3 if AbbVie has the right to terminate this Agreement in its entirety or with respect to the Ophthalmology Program, the amount of any Ophthalmology Milestone Payments payable by AbbVie to Capsida pursuant to Section 9.5 for any Ophthalmology Milestone Event achieved after the Modification Date shall be reduced by ... |
14.4.4 if the breach that gives rise to such right to terminate substantially relates to the Collaboration Research Program or the ALS Product, AbbVie shall have the right to terminate Capsida's rights to jointly Develop and Commercialize the ALS Product in the United States and the Profit Share Term will cease; provid... |
(a) Capsida shall continue to receive fifty percent (50%) of all Net Profits through the Modification Date and bear fifty percent (50%) of all Net Losses and fifty percent (50%) of all Allowable Expenses accrued with respect to the ALS Product through the Modification Date; |
(b) AbbVie shall pay to Capsida a royalty on Calendar Year Net Sales of the ALS Product in the Territory starting from the Modification Date until the end of the Royalty Term at the following rates: |
Net Sales in a Calendar Year of the ALS Product Royalty Rate |
For that portion of Calendar Year Net Sales less than One Billion Dollars (US$1,000,000,000) Six Percent (6%) |
For that portion of Calendar Year Net Sales greater than or equal to One Billion Dollars (US$1,000,000,000) but less than Two Billion Dollars (US$2,000,000,000) Seven Percent (7%) |
For that portion of Calendar Year Net Sales greater than or equal to Two Billion Dollars (US$2,000,000,000) Eight Percent (8%) |
(c) the ALS Product shall become a Royalty Product for purposes of this Agreement; and |
(d) AbbVie shall pay to Capsida milestone payments 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 ALS Milestone Events by the ALS Product that are achieved after the Modification Date during the Term, calculated as follows: |
ALS Milestone Event ALS Milestone Payment |
First Commercial Sale of the ALS Product in the United States by or on behalf of AbbVie Sixty Million Dollars (US$60,000,000) |
First Commercial Sale of the ALS Product in a Major European Market by or on behalf of AbbVie Forty-Five Million Dollars (US$45,000,000) |
First Commercial Sale of the ALS Product in the first ROW Market by or on behalf of AbbVie Twenty-Five Million Dollars (US$25,000,000) |
14.4.5 AbbVie's exclusivity obligations under Section 8.8.3 and AbbVie's diligence obligations under Section 4.1.2 and Section 4.2.6 shall all terminate; provided that if AbbVie has the right to terminate this Agreement with respect to a Program, but not its entirety, the foregoing obligations shall only terminate with... |
14.4.6 all other provisions of this Agreement shall remain in full force and effect without change. |
14.5 Consequences of Termination. Without limiting any other legal or equitable remedies that either Party may have under this Agreement: |
14.5.1 Termination in its Entirety. If this Agreement is terminated in its entirety: |
(a) Milestones. No milestone payments by AbbVie will be due on milestones achieved during the period between the notice of termination under this Article 14 and the effective date of termination. |
(b) Post-Termination Licenses. If this Agreement is terminated in its entirety at any time during the Term for any reason, the license grants to AbbVie in Section 8.1 and the license grants to Capsida in Section 8.2.1, Section 8.2.2 and Section 8.2.3 shall terminate immediately and for clarity, (i) AbbVie shall have no... |
14.5.2 Termination of a Terminated Territory. If this Agreement is terminated with respect to a Terminated Territory with respect to a Program, but not in its entirety: |
(a) Milestones. No milestone payments by AbbVie will be due on milestones achieved with respect to such Program and such Terminated Territory during the period between the notice of termination under this Article 14 and the effective date of termination. |
(b) Post-Termination Licenses. The license grants to AbbVie in Section 8.1 shall automatically be deemed to be amended to (i) exclude the right to seek Regulatory Approval or Commercialize (x) with respect to termination of the Neurology Program, the Licensed Products in the Field in such Terminated Territory or (y) wi... |
(c) Terminated Territory Management. Neither Party shall, and shall not permit any of its Affiliates, and shall use commercially reasonable efforts not to permit any of its and their Sublicensees or Distributors to, distribute, market, promote, offer for sale or sell any Licensed Products or Licensed Ophthalmology Prod... |
14.5.3 Termination of a Target or Licensed Target or Final Selected Ophthalmology Target. If this Agreement is terminated with respect to a Target or a Licensed Target or a Final Selected Ophthalmology Target, but not in its entirety: |
(a) Milestones. No milestone payments by AbbVie will be due on milestones achieved with respect to such Licensed Target or Final Selected Ophthalmology Target, as applicable, during the period between the notice of termination under this Article 14 and the effective date of termination. |
(b) Post-Termination Licenses. The license grants to AbbVie in Section 8.1 and the license grants to Capsida in Section 8.2.1 and (i) Section 8.2.2 (in the case of a Target or Licensed Target) or (ii) Section 8.2.3 (in the case of a Final Selected Ophthalmology Target) shall terminate immediately with respect to such T... |
14.5.4 Termination of Collaboration Research Program. If AbbVie terminates the Collaboration Research Program other than for Good Reason, Capsida shall have the Right to Exploit ALS Reversion Products on the terms and conditions set forth in Section 4.4. For clarity, (a) AbbVie shall have no rights under, in or to, and... |
14.5.5 Termination of a Route of Administration. If AbbVie terminates the Ophthalmology Research Program with respect to a Route of Administration, AbbVie shall have no rights under, in or to, and shall not use any Capsida Background IP, Capsida Platform IP, the Capsida Platform, or the Licensed Capsids with respect to... |
14.6 Remedies. Except as otherwise expressly provided herein, termination of this Agreement (either in its entirety or with respect to one (1) or more Terminated Territory(ies), Research Program(s), Programs, the Ophthalmology Research Program with respect to a Route of Administration, Target(s), Licensed Target(s), or... |
14.7 Accrued Rights; Surviving Obligations. |
14.7.1 Termination or expiration of this Agreement (either in its entirety or with respect to one (1) or more Terminated Territory(ies), Target(s) or Licensed Target(s), Final Selected Ophthalmology Target(s) or Routes of Administration) for any reason shall be without prejudice to any rights that shall have accrued to... |
14.7.2 Notwithstanding the termination of AbbVie's licenses and other rights under this Agreement, AbbVie shall have the right (to the extent consistent with applicable Law and subject to the Parties' negotiation and execution of a safety data exchange agreement and any other agreements necessary for the Parties and th... |
ARTICLE 15 MISCELLANEOUS |
15.1 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 when such failure or delay is caused by or results from events beyond the reasonable contro... |
15.2 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 the Parties from time to time. Each Party agrees that it will not export, directly or indirectly, any technical information ... |
15.3 Assignment. |
15.3.1 This Agreement may not be assigned or otherwise transferred, nor may any right or obligation hereunder be assigned or transferred (except to the extent provided in Section 2.6.2), whether by operation of law or otherwise, in whole or in part, by either Party without the written consent of the other Party, which ... |
15.3.2 AbbVie and Capsida each agrees that, notwithstanding any provision of this Agreement to the contrary, if Capsida or AbbVie, respectively, undergoes a Change of Control (the "Change of Control Party"), any Patent, Know-How or other intellectual property or other proprietary rights that are owned or otherwise cont... |
15.4 Certain Strategic Transactions. Subject to Section 8.1 and the remainder of this Section 15.4, the restrictions in Section 8.8 and Section 11.6 shall not preclude (a) in the event of a Change of Control of a Party, the Acquirer or any of its Affiliates (other than such Party and any Person that was an Affiliate of... |
15.5 Severability. If any provision of this Agreement is held to be illegal, invalid or unenforceable under any present or future law and if the rights or obligations of either Party under this Agreement will not be materially and adversely affected thereby, (a) such provision shall be fully severable, (b) this Agreeme... |
15.6 Dispute Resolution. Except for disputes resolved by the procedures set forth in Section 7.2.3, Section 9.21.2 or Section 15.11, if a dispute arises between the Parties in connection with or relating to this Agreement or any document or instrument delivered in connection herewith (a "Dispute"), it shall be resolved... |
15.6.1 General. Any 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 shall be conclusive and binding on the Parties. If the Senior Officers are not able to agree on the resol... |
15.6.2 Intellectual Property Disputes. In the event that a Dispute arises with respect the validity, scope, enforceability or ownership of any Patent, Trademark or other intellectual property rights, and such Dispute cannot be resolved in accordance with Section 15.6.1, unless otherwise agreed by the Parties in writing... |
15.6.3 ADR. Any ADR proceeding under this Agreement shall take place pursuant to the procedures set forth in Schedule 15.6.3. |
15.6.4 Adverse Ruling. Any determination pursuant to this Section 15.6 that a Party is in material breach of its material obligations hereunder shall specify a (nonexclusive) set of actions to be taken to cure such material breach, if feasible. |
15.6.5 Interim Relief. Notwithstanding anything herein to the contrary, nothing in this Section 15.6 shall preclude either Party from seeking interim or provisional relief, including a temporary restraining order, preliminary injunction or other interim equitable relief concerning a Dispute, if necessary to protect the... |
15.7 Governing Law, Jurisdiction and Service. |
15.7.1 Governing Law. This 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 New York, United States, excluding any conflicts or choice of law rule or principle that might otherwise refer construction or in... |
15.7.2 Jurisdiction. Subject to Section 14.7, Section 15.6 and Section 15.11, the Parties hereby irrevocably and unconditionally consent to the exclusive jurisdiction of the courts of New York for any action, suit or proceeding (other than appeals therefrom) arising out of or relating to this Agreement and agree not to... |
15.7.3 Venue. The Parties further hereby irrevocably and unconditionally waive any objection to the laying of venue of any action, suit or proceeding (other than appeals therefrom) arising out of or relating to this Agreement in the courts of New York and hereby further irrevocably and unconditionally waive and agree n... |
15.7.4 Service. Each Party further agrees that service of any process, summons, notice or document by registered mail to its address set forth in Section 15.8.2 shall be effective service of process for any action, suit or proceeding brought against it under this Agreement in any such court. |
15.8 Notices. |
15.8.1 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 co... |
15.8.2 Address for Notice. |
If to AbbVie, to: |
AbbVie Global Enterprises Ltd. 4th Floor, Washington House 16 Church Street Hamilton HM 11 Bermuda |
with a copy (which shall not constitute notice) to: |
AbbVie Inc. 1 North Waukegan Road North Chicago, Illinois 60064 United States Attention: Executive Vice President, External Affairs, General Counsel and Corporate Secretary |
If to Capsida, to: |
Capsida Biotherapeutics, Inc. 1300 Rancho Conejo Blvd Thousand Oaks CA 91320 Attention: Peter Anastasiou |
15.9 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,... |
15.10 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 ... |
15.11 Equitable Relief. Each Party acknowledges and agrees that the restrictions and obligations set forth in Section 8.8 and Article 10 and Article 11 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 ... |
15.12 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. Th... |
15.13 No Benefit to Third Parties. Except as provided in Article 13, 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 Persons. |
15.14 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... |
15.15 Relationship of the Parties. It is expressly agreed that Capsida, on the one hand, and AbbVie, 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, including for all tax purposes. Neither Capsida, on the ... |
15.16 References. Unless otherwise specified, (a) references in this Agreement to any Article, Section or Schedule shall mean 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, ... |
15.17 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). Whenever this Agreement refers to a number of days, unless o... |
15.18 Counterparts. This Agreement may be executed in two (2) or more 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, .pdf format via email or other electronically transmitted signatures and suc... |
ARTICLE 16 AMENDMENT AND RESTATEMENT |
16.1 Amendment and Restatement. From the Effective Date, this Agreement amends and restates the Original Agreement in its entirety, so that the rights and obligations of the Parties to this Agreement shall, on and from the Effective Date, be governed by and construed in accordance with the provisions of this Agreement.... |
[SIGNATURE PAGE FOLLOWS.] |
THIS AGREEMENT IS EXECUTED by the authorized representatives of the Parties as of the date first written above. |
ABBVIE GLOBAL ENTERPRISES LTD. |
By: |
Name: Arthur C. Price |
Title: Director |
CAPSIDA BIOTHERAPEUTICS, INC. |
By: |
Name: _____________________________ |
Title: ______________________________ |
THIS AGREEMENT IS EXECUTED by the authorized representatives of the Parties as of the date first written above. |
ABBVIE GLOBAL ENTERPRISES LTD. |
By: |
Name: _____________________________ |
Title: ______________________________ |
CAPSIDA BIOTHERAPEUTICS, INC. |
By: |
Name: Peter Anastasiou |
Title: Chief Executive Officer |
Exhibit A Capsid Program Research Plan |
1.0 Background |
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. |
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)... |
2.0 Research Plan Scope and Framework |
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 (i.e., Capsid Program Research Plan) outlines activities and estimated timelines to be conducted by Capsida or AbbVie, as specified below, for... |
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