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12.2.15 Capsida has made available to AbbVie (a) all Capsida NP Regulatory Filings (and any documentation or correspondence, including conversation logs, relating to or supporting such Regulatory Filings), and (b) to Capsida's Knowledge, all Capsida Background Know-How regarding the safety or efficacy of any Program Ca... |
12.2.16 Capsida and its Affiliates have generated, prepared, maintained and retained all Capsida NP Regulatory Filings that are required to be maintained or retained pursuant to and in accordance with Applicable Law and all such information is complete and correct and what it purports to be, in each case in all materia... |
12.2.17 No license or other agreement between Capsida or any of its Affiliates, on the one hand, and a Third Party, on the other hand was entered into pursuant to Section 8.4.2 of the Original Agreement; |
12.2.18 Between the Original Agreement Effective Date and the Effective Date, Capsida did not amend any Existing CMO Agreements or enter into any additional agreement(s) with Third Party manufacturer(s) to supply Capsids or components for performance of the Research Plan; and |
12.2.19 Neither Capsida 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)), that (x) would be or create an untrue statement of material fact or fraudulen... |
provided, that during the period from the Original Agreement Effective Date or Neurology Option Bringdown Date, as applicable, until the later of (a) the date AbbVie exercises the applicable Option and (b) the expiration of the applicable Option Period, Capsida shall promptly notify AbbVie in writing if any of the repr... |
12.3 Representations, and Warranties of Capsida for the Ophthalmology Program. Capsida hereby represents and warrants to AbbVie with respect to the Ophthalmology Program as of the Effective Date: (a) except as set forth in Schedule 12.3 attached hereto (the "Ophthalmology Initial Disclosure Schedule") as of the Effecti... |
12.3.1 Capsida is entitled to grant the licenses specified herein. Except with respect to the Existing In-License Agreements as set forth on Schedule 12.3.1 and any Future Capsida In-License Agreements to the extent agreed by AbbVie pursuant to Section 8.4.2, (a) Capsida to its Knowledge Controls all Licensed IP, (b) n... |
12.3.2 Except with respect to the sequence of an AbbVie Ophthalmology Cargo that may be encoded thereby (with respect to which Capsida is making no representation or warranty under this Section 12.3.2), (a) the conduct of the Ophthalmology Research Plan and (b) to the Knowledge of Capsida, (i) the Exploitation of the O... |
12.3.3 The conduct of the Ophthalmology Research Program and the Research, Development, Manufacture or Commercialization of the Ophthalmology Program Capsids, Reserved Ophthalmology Capsids, Selected Ophthalmology Capsids, Licensed Ophthalmology Capsids or Licensed Ophthalmology Products as contemplated herein are not,... |
12.3.4 All Capsida Background Patents and Capsida Platform Patents existing as of such date (collectively, the "Existing OP Patents") are listed on Schedule 12.3.4 (as such schedule may be supplemented in connection with any Ophthalmology Updated Disclosure Schedule) and identified as Capsida Managed Patents or Third P... |
12.3.5 all Existing In-License Agreements and, as of the applicable Ophthalmology Option Bringdown Date, Future Capsida In-License Agreements have been provided to AbbVie; |
12.3.6 All of the Existing In-License Agreements, and, as of the applicable Ophthalmology Option Bringdown Date, all Future Capsida In-License Agreements, are listed on the applicable portion of Schedule 12.3.1 as such schedule may be supplemented in connection with the delivery of any Updated Disclosure Schedule, and ... |
12.3.7 Neither Capsida nor any of its Affiliates has entered into any agreement, whether written or oral, that (a) assigns, transfers, licenses, conveys or otherwise encumbers (including by granting a covenant not to sue with respect to) Capsida's right, title or interest in or to, or (b) grants any Third Party any rig... |
12.3.8 As of the Effective Date there are no Capsida OP Regulatory Filings; |
12.3.9 No claim or litigation has been brought or asserted by a Third Party in writing (and Capsida has no Knowledge of any claim, whether or not brought or asserted by a Third Party in writing) alleging that (a) the issued patents in the Existing OP Patents, the Capsida Background Patents or the Capsida Platform Paten... |
12.3.10 Except as described in the In-License Agreements previously provided to AbbVie, there are no amounts that will be required to be paid to a Third Party as a result of (a) the Exploitation of the Capsida Platform and Capsida Platform IP in Capsida's conduct of the Ophthalmology Research Program or (b) the Exploit... |
12.3.11 To Capsida's Knowledge, no Person is infringing or threatening to infringe, or misappropriating or threatening to misappropriate, the Existing OP Patents, the Capsida Background Know-How, the Capsida Platform IP or any Capsida OP Regulatory Filings, in each case in a manner that would affect AbbVie's rights und... |
12.3.12 Each of the Capsida Managed Patents and, to Capsida's Knowledge, each of the Third Party Managed Patents, properly identifies, or when issued will identify, each and every inventor of the claims thereof as determined in accordance with the Applicable Law of the jurisdiction in which such Existing OP Patent is i... |
12.3.13 (a) There are no pending, and to Capsida's Knowledge, there are no alleged or threatened, (i) inter partes reviews, post-grant reviews, interferences, re-examinations or oppositions involving the Capsida Managed Patents that are in or before any patent authority (or other governmental authority performing simil... |
12.3.14 With respect to the Patents licensed to AbbVie under Section 8.1, except to the extent any such Patent is in-licensed by Capsida or any of Capsida's Affiliates, all named inventors of such Patents have properly assigned to Capsida (or to an Affiliate or Third Party that assigned to Capsida) each such inventor's... |
12.3.15 To Capsida's Knowledge, other than inventions and intellectual property licensed under the CalTech License Agreement, the inventions covered by the Existing OP Patents (a) were not conceived, discovered, developed or otherwise made in connection with any research activities funded, in whole or in part, by the f... |
12.3.16 Capsida has made available to AbbVie (a) all Capsida OP Regulatory Filings (and any documentation or correspondence, including conversation logs, relating to or supporting such Regulatory Filings), and (b) to Capsida's Knowledge, all Capsida Background Know-How regarding the safety or efficacy of any Ophthalmol... |
12.3.17 Capsida and its Affiliates have generated, prepared, maintained and retained all Capsida OP Regulatory Filings that are required to be maintained or retained pursuant to and in accordance with Applicable Law and all such information is complete and correct and what it purports to be, in each case in all materia... |
12.3.18 Between the Original Agreement Effective Date and the Effective Date, Capsida did not amend any Existing CMO Agreements or enter into any additional agreement(s) with Third Party manufacturer(s) to supply Capsids or components for performance of the Ophthalmology Research Plan; and |
12.3.19 Neither Capsida 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)), that (x) would be or create an untrue statement of material fact or fraudulen... |
provided, that during the period from the Effective Date or Ophthalmology Option Bringdown Date, as applicable, until the later of (a) the date AbbVie exercises the applicable Option and (b) the expiration of the applicable Option Period, Capsida shall promptly notify AbbVie in writing if any of the representations and... |
12.4 Additional Representations and Warranties of Capsida as of the Option Bringdown Date. Capsida additionally represents and warrants to AbbVie, except, subject to Section 12.5.2, as set forth in any Updated Disclosure Schedule as of the applicable Neurology Option Bringdown Date or Ophthalmology Option Bringdown Dat... |
12.4.1 Capsida and its Affiliates have conducted, and its and their respective contractors and consultants have conducted, all Research under each applicable Plan, including any and all pre-clinical and clinical studies related to the Program Capsids, Reserved Capsids, Research Products and Selected Capsids, or the Oph... |
12.4.2 each applicable Final Data Package is, with respect to Results, information and Know-How generated by or on behalf of Capsida or its Affiliates under or in connection with the Research Program, and each applicable Final Ophthalmology Data Package is, with respect to Results, information and Know-How generated by... |
12.4.3 neither Capsida nor any of its Affiliates has been debarred or is subject to debarment and neither it nor 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 sub... |
provided, that during the period from the applicable Ophthalmology Option Bringdown Date or the Neurology Option Bringdown Date, as applicable, until the later of (a) the date AbbVie exercises the applicable Option and (b) the expiration of the applicable Option Period, Capsida shall promptly notify AbbVie in writing i... |
12.5 Updated Disclosure Schedule and Bringdown. |
12.5.1 Subject to Section 12.5.2, Capsida shall provide AbbVie updated disclosure schedules with the delivery of (a) with respect to the Neurology Program, each Final Data Package with respect to each Target and Research Stage and (b) with respect to the Ophthalmology Program, each Final Ophthalmology Data Package with... |
12.5.2 The Parties agree that any disclosure made by Capsida pursuant to an Updated Disclosure Schedule shall not be deemed to amend or supplement the Neurology Initial Disclosure Schedule, Ophthalmology Initial Disclosure Schedule, or any earlier Updated Disclosure Schedule for any purpose hereunder, including for pur... |
12.6 Mutual Covenants. Each Party hereby covenants to the other Party that: |
12.6.1 such Party shall use Commercially Reasonable Efforts to cause all Persons who perform Research, Development or Manufacturing activities or regulatory activities for such Party under the Research Program or the POC Plan or the Ophthalmology Research Program and who conceive, discover, develop or otherwise make an... |
12.6.2 in performing its obligations or exercising its rights under this Agreement, such Party, its Affiliates, and its and their /Sublicensees, shall comply with Applicable Law in all material respects; and |
12.6.3 such Party will not grant any license relating to the Capsida Background IP, Program IP or Joint IP (if such Party is Capsida) or the AbbVie Background IP, Cargo IP, Program IP or Joint IP (if such Party is AbbVie) that would be inconsistent with this Agreement. |
12.7 Additional Covenants of Capsida. From and after the Effective Date: |
12.7.1 Capsida shall not, and shall cause its Affiliates not to, misappropriate any Know-How of a Third Party. Capsida shall not Knowingly, and shall not Knowingly cause its Affiliates to infringe any published or issued Patent (or, with respect to any Patent application, take any action that would constitute infringem... |
12.7.2 Capsida shall not, and shall cause its Affiliates not to, subject to Section 8.4, enter into any agreement, whether written or oral, with respect to, any of the Program Capsids, Ophthalmology Program Capsids, Reserved Capsids, Reserved Ophthalmology Capsids, Research Products, Ophthalmology Research Products, Se... |
12.7.3 Capsida shall not, and shall cause its Affiliates not to, use any funds from the federal government of the United States or any agency thereof to fund, directly or indirectly, any Research or Development activities hereunder, in whole or in part; |
12.7.4 Capsida shall not, and shall cause its Affiliates not to, use any Know-How, Patents or Regulatory Documentation that is not Controlled by Capsida in connection with the conduct of the Research Program or the Ophthalmology Research Program or any of its other activities under this Agreement; |
12.7.5 Capsida shall, and shall cause its Affiliates to, maintain the Patents within the Licensed IP (or, with respect to any Licensed IP in-licensed by Capsida or any of its Affiliates pursuant to an In-License Agreement its rights and interest therein), free of any encumbrance, lien or claim of ownership by any Third... |
12.7.6 Capsida shall not, and shall cause its Affiliates not to, (a) commit any acts or permit the occurrence of any omissions that would cause any material breach by Capsida of or termination of any In-License Agreement or (b) amend or otherwise modify or Knowingly permit to be amended or modified, any In-License Agre... |
12.7.7 Capsida shall, and shall cause its Affiliates to, ensure that the Exploitation of each (a) Program Capsid, Reserved Capsid, Research Product, Licensed Capsid or Licensed Product, in each case with respect to the Licensed Target(s) and (b) Ophthalmology Program Capsid, Reserved Ophthalmology Capsid, Ophthalmology... |
12.7.8 Each Data Package and Final Data Package and Final Ophthalmology Data Package (together with such 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 within five (5) Business days or ten (10) Business Days, as appli... |
12.7.9 Capsida shall not, and shall cause its Affiliates not to (a) commit any act, (b) make any statement or (c) fail to act or make a statement that, in any case ((a), (b) or (c)), that (i) would be or create an untrue statement of material fact or fraudulent statement to the FDA or any other governmental authority w... |
12.7.10 Capsida shall not, and shall cause it Affiliates not to, 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. Capsida agrees to inform Ab... |
12.7.11 promptly following AbbVie's request, upon the initiation of the first final individual Capsid-cargo characterization conducted pursuant to (a) Section 2.3.8 for a Target or (b) Section 2.13.8 for an Ophthalmology Target, Capsida shall (i) take all actions necessary to provide AbbVie with the rights to the appli... |
12.8 Additional Representations and Warranties with respect to ALS Cargo and AbbVie Ophthalmology Cargo and AbbVie Obligations; Additional Acknowledgements. |
12.8.1 AbbVie hereby represents and warrants to Capsida as of the Effective Date, with respect to the ALS Cargo, that (a) AbbVie has the right to provide such ALS Cargo to Capsida and (b) to AbbVie's knowledge, Capsida's Exploitation of the ALS Cargo for the Permitted Uses does not infringe a Third Party's intellectual... |
12.8.2 AbbVie hereby represents and warrants to Capsida as of the Effective Date that: |
(a) with respect to the AbbVie Ophthalmology Cargo and the AbbVie Ophthalmology Materials, (i) AbbVie has the right to provide such AbbVie Ophthalmology Cargo and AbbVie Ophthalmology Materials to Capsida and (ii) to AbbVie's knowledge, Capsida's Exploitation of the AbbVie Ophthalmology Cargo and the AbbVie Ophthalmolo... |
(b) to AbbVie's knowledge, (i) the analysis methods and any devices that are contemplated by AbbVie as of the Effective Date to be used by AbbVie in the performance of its in-life activities under the Ophthalmology Research Program pursuant to Sections 2.13.2 to 2.13.9 (the "AbbVie Methods") do not infringe any Patent ... |
12.9 Data Privacy and Security. |
12.9.1 For all Personal Data collected, Processed, hosted, or transmitted in performance of this Agreement and exercise of rights herein, including, but not limited to, the conduct of any clinical trials and the preparation and transmission of the Data Packages, each Party shall: |
(a) comply at all times with the Data Protection Laws; |
(b) to the extent permitted by Applicable Law, notify the other Party, as soon as practicable and in any event prior to making the relevant disclosure, if it is obliged to make a disclosure of the Personal Data under any statutory requirement; |
(c) make timely notification to and obtain any necessary authorizations from any relevant data protection regulator where required under applicable Data Protection Laws of its collection and other Processing of Personal Data in order to comply with its obligations under this Agreement; |
(d) at all times, act in a manner such that it is not subject to any prohibition or restriction which shall (i) prevent or restrict it from disclosing or transferring the Personal Data to the other Party, as required under this Agreement; or (ii) prevent or restrict either Party from Processing the Personal Data as env... |
(e) ensure that all fair Processing or informed consent notices have been obtained and are maintained and are sufficient in scope to enable it to Process the Personal Data as required in order to comply with its obligation under this Agreement to obtain the benefit of its rights and to fulfil its obligations under this... |
(f) implement and maintain reasonable administrative, technical, and physical safeguards designed to (i) maintain the security and confidentiality of the Personal Data; (ii) protect against reasonably anticipated threats or hazards to the security or integrity of the Personal Data; and (iii) protect against unauthorize... |
(g) notify the other Party promptly, and in any event within forty-eight (48) hours of receipt of any correspondence from: (a) a data protection regulator in relation to the Processing of Personal Data related to this Agreement, or (b) a request or notice from a data subject exercising his rights under the Data Protect... |
(h) refrain from taking actions related to the Processing of the Personal Data, which would be reasonably likely to damage or impair the other Party's reputation. |
12.9.2 Data Export. In the event Capsida needs to transfer EEA Personal Data to an entity in a Third Country, Capsida shall enter into then-applicable standard contractual clauses or other required agreements under Applicable Law with the relevant data importer. The Parties agree that if the Standard Contractual Clause... |
12.9.3 Security Breach Notification. Capsida shall notify AbbVie immediately upon learning of any actual or suspected misappropriation or unauthorized access to, or disclosure or use of the Personal Data (a "Data Breach"). Capsida shall promptly investigate each Data Breach that it becomes aware of or has reason to sus... |
12.10 DISCLAIMER OF WARRANTIES. EXCEPT FOR THE EXPRESS WARRANTIES SET FORTH IN THIS ARTICLE 12 AND SECTION 3.4.4, NEITHER PARTY MAKES ANY REPRESENTATIONS OR GRANTS ANY WARRANTIES, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE AND EACH PARTY SPECIFICALLY DISCLAIMS ANY OTHER WARRANTIE... |
12.11 Anti-Bribery and Anti-Corruption Compliance. Each Party represents, warrants, and covenants to the other Party in connection with this Agreement that such first Party and its Affiliates (a) have complied and will comply with all applicable laws, rules, regulations and industry codes governing bribery, money laund... |
ARTICLE 13<br>INDEMNITY |
13.1 Indemnification of Capsida. Subject to Section 13.3, AbbVie shall indemnify Capsida, its Affiliates and, solely with respect to the ALS Reversion Product, its and their Sublicensees and distributors, and its and their respective directors, officers, employees and agents (collectively, the "Capsida Indemnitees"), a... |
13.2 Indemnification of AbbVie. Subject to Section 13.3, Capsida shall indemnify AbbVie, its Affiliates, its and their Sublicensees and Distributors and its and their respective directors, officers, employees and agents (collectively, "AbbVie Indemnitees"), and defend and save each of them harmless, from and against an... |
13.3 Certain Losses. Notwithstanding the foregoing, any Losses in connection with any Third Party Claim incurred by or rendered against either Party or any of its Affiliates or other of such Party's Indemnitees to the extent arising from or occurring as a result of (a) the Development or Commercialization of any ALS Pr... |
13.3.1 with respect to any such Losses incurred by AbbVie or any AbbVie Indemnitees: |
(a) any such Losses to the extent Capsida provides indemnification pursuant to Section 13.2 or pursuant to the applicable clinical supply agreement entered into by the Parties pursuant to Section 5.2 or the Co-Promotion Agreement (if any); and |
(b) any such Losses to the extent arising from or occurring as a result of any of the matters set forth in clause (a), (b) or (c) of Section 13.1 (whether or not the applicable Third Party Claim was incurred by or rendered against the Capsida Indemnitee); and |
13.3.2 with respect to any such Losses incurred by Capsida or any Capsida Indemnitee: |
(a) any such Losses to the extent AbbVie provides indemnification pursuant to clause (a), (b) or (c) of Section 13.1 or pursuant to the applicable clinical supply agreement entered into by the Parties pursuant to Section 5.2 or the Co-Promotion Agreement (if any); and |
(b) any such Losses to the extent arising from or occurring as a result of any of the matters set forth in Section 13.2 (whether or not the applicable Third Party Claim was incurred by or rendered against the AbbVie Indemnitees). |
13.4 Indemnification Procedures. |
13.4.1 Notice of Claim. All indemnification claims in respect of a Party, its Affiliates or, in the case of AbbVie, its or their Sublicensees or Distributors, or its or their respective directors, officers, employees and agents (each, an "Indemnitee") shall be made solely by such Party (the "Indemnified Party"). The In... |
13.4.2 Control of Defense. Subject to Section 10.4 and Section 10.5, at its option, the indemnifying Party may assume the defense of any Third Party Claim by giving written notice to the Indemnified Party within thirty (30) days after the indemnifying Party's receipt of an Indemnification Claim Notice. The assumption o... |
13.4.3 Right to Participate in Defense. Any Indemnified Party shall be entitled to participate in, but not control, the defense of such Third Party Claim and to employ counsel of its choice for such purpose; provided, however, that such employment shall be at the Indemnified Party's sole cost and expense unless (a) the... |
13.4.4 Settlement. With respect to any Losses relating solely to the payment of money damages in connection with a Third Party Claim and that shall not result in the applicable Indemnitee's becoming subject to injunctive or other relief or otherwise adversely affecting the business of the applicable Indemnitee in any m... |
13.4.5 Cooperation. Regardless of whether the indemnifying Party chooses to defend or prosecute any Third Party Claim, the Indemnified Party shall and shall cause each Indemnitee to, cooperate in the defense or prosecution thereof and shall furnish such records, information and testimony, provide such witnesses and att... |
13.4.6 Expenses. Except as provided above, the costs and expenses, including fees and disbursements of counsel, incurred by the Indemnified Party in connection with any claim shall be reimbursed on a Calendar Quarter basis by the indemnifying Party, without prejudice to the indemnifying Party's right to contest the Ind... |
13.5 Insurance. Each Party shall have and maintain such type and amounts of insurance covering its activities hereunder as is reasonable under the circumstances, including insurance as is: (a) normal and customary in the research-based pharmaceutical industry generally for parties similarly situated; and (b) otherwise ... |
13.6 Limitation of Liability. EXCEPT (A) FOR A BREACH OF SECTION 8.8 OR ARTICLE 11, OR (B) TO THE EXTENT ANY SUCH DAMAGES ARE REQUIRED TO BE PAID TO A THIRD PARTY FOR CLAIMS THAT ARE SUBJECT TO INDEMNIFICATION UNDER THIS ARTICLE 13 OR (C) DUE TO A PARTY'S GROSS NEGLIGENCE OR WILLFUL MISCONDUCT, NEITHER CAPSIDA NOR ABBV... |
ARTICLE 14 TERM AND TERMINATION |
14.1 Term and Expiration. This Agreement shall commence as of the Effective Date and, unless terminated earlier, this Agreement shall continue in full force and effect until the first to occur of: (a) the later of the expiration of the Capsid Program Option Period, the Collaboration Program Option Period and the Ophtha... |
14.2 Termination. |
14.2.1 Material Breach. |
(a) In the event that either Party (the "Breaching Party") materially breaches any of its material obligations under this Agreement, in addition to any other right and remedy the other Party (the "Non-Breaching Party") may have, the Non-Breaching Party may terminate this Agreement by providing ninety (90) days' (the "N... |
(b) Notwithstanding clause (a), if the material breach and failure to cure contemplated by clause (a) (i) is with respect to AbbVie's diligence obligations under Section 4.1.2 or Section 4.2.6 with respect to a Program in the United States or one (1) or more Major European Markets, but not the United States or all of t... |
14.2.2 Termination by AbbVie. Without limitation of Section 2.14, AbbVie may terminate this Agreement (a) (i) in its entirety at any time, (ii) with respect to either or both Programs, one (1) or more countries in the Territory, on a country-by-country basis, (iii) with respect to one or more Target(s) or Licensed Targ... |
14.2.3 Termination for Insolvency. In the event that either Party (a) files for protection under bankruptcy or insolvency laws, (b) makes an assignment for the benefit of creditors, (c) appoints or suffers appointment of a receiver or trustee over substantially all of its property that is not discharged within ninety (... |
14.2.4 Termination for Anti-Bribery or Anti-Corruption Non-Compliance. AbbVie may terminate this Agreement in accordance with Section 12.11. |
14.3 Rights in Bankruptcy. All rights and licenses granted under or pursuant to this Agreement by AbbVie or Capsida are and shall otherwise be deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code or any analogous provisions in any other country or jurisdiction, licenses of rights to "intellectual pr... |
14.4 Modification In Lieu of Termination. If, at any time during the Term, AbbVie has the right to terminate this Agreement pursuant to Section 14.2.1 (in its entirety or with respect to a Program) or Section 14.2.3, then AbbVie may, by written notice to Capsida, elect to continue this Agreement as modified by this Sec... |
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