text stringlengths 1 5.46k |
|---|
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 ir... |
ARTICLE 3 EXCLUSIVE OPTIONS |
3.1 Option Grants. |
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 O... |
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 i... |
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... |
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 ... |
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 acce... |
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 Optio... |
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: |
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 Opht... |
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 Pro... |
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; |
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... |
3.4.5 Regulatory Documentation. Capsida shall and hereby does assign to AbbVie all of its right, title, and interest in and to all Regulatory Documentation (and as applicable, shall transfer all INDs and other analogous Regulatory Documentation to AbbVie so AbbVie is the Sponsor, as defined under Applicable Law) relati... |
3.4.6 Records. Capsida shall deliver to AbbVie the original version of all Research Program Records or Ophthalmology Program Research Records to the extent relating to the applicable Licensed Capsids, Licensed Products, Licensed Ophthalmology Capsids and Licensed Ophthalmology Products; provided, however, that Capsida ... |
3.4.7 Patent Matters. Without limiting Section 3.4.2 and to the extent consistent with AbbVie's first right to Prosecute and Maintain the relevant Patents under Article 10, Capsida shall assist and cooperate with AbbVie, as AbbVie may reasonably request, in the transition of the Prosecution and Maintenance, enforcement... |
3.4.8 Execution. Capsida 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 c... |
provided, however, with respect to any part of the Ophthalmology Research Program, Research Program or the POC Plan that is ongoing, Capsida shall be permitted to retain copies of such Regulatory Documentation and Ophthalmology Research Program Records or Research Program Records, as applicable, and such quantities of ... |
3.5 Allocation of Rights with Respect to Transferred Contracts. To the extent that the assignment by Capsida of any agreement pursuant to Section 3.4 or Section 5.3 requires any notice to or consent of the relevant Third Party counterparty to such agreement, or requires the separation of such agreement into an agreemen... |
3.6 HSR. |
3.6.1 If AbbVie reasonably determines in good faith prior to the delivery of the Exercise Notice for any Option that the transactions to be consummated upon the exercise of such Option require HSR Filings, AbbVie shall provide the Exercise Notice for such Option to Capsida prior to the end of the applicable Option Peri... |
3.6.2 In connection with the Parties activities under this Section 3.6, AbbVie and Capsida 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 ... |
3.6.3 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 ... |
3.6.4 If the exercise by AbbVie of any Option under Section 3.3 requires the making of filings under the HSR Act, then all rights and obligations related to the exercise of such Option (including payment of any Option exercise fee) and the granting of the exclusive license under Section 8.1.4 or Section 8.1.5 shall be ... |
3.7 Non-Exercise of Options. |
3.7.1 Non-Exercise of Capsid Program Options. Subject to Section 8.8: |
(a) If AbbVie does not exercise the Capsid Program Option for a particular Target and Research Stage, then Capsida shall have the right to Exploit the Capsid Program Capsids (but not the Research Products) that are the subject of such Capsid Program Option unless such Capsid Program Capsids are Reserved Capsids or Sele... |
(b) If AbbVie does not exercise the Initial Capsid Program Option for either α-syn or Tau, then AbbVie shall not have the right to pursue Research Stage Two with respect to α-syn or Tau, respectively; and |
(c) If AbbVie does not exercise a Capsid Program Option for one of α-syn or Tau (but does exercise a Capsid Program Option for the other), then Capsida shall have the right to Exploit the Capsid Program Capsids (but not the Research Products) that are the subject of such Capsid Program Option unless such Capsid Program... |
(d) If AbbVie does not exercise a Capsid Program Option for a Research Stage for one or both of α-syn or Tau, each Party shall either promptly destroy or return to the other Party, at the other Party's election, all Confidential Information of such Party and materials provided to the other Party, and shall destroy all ... |
3.7.2 Non-Exercise of Collaboration Program Option. |
(a) If AbbVie (i) does not exercise an Initial Capsid Program Option for both α-syn and Tau or (ii) exercises an Initial Capsid Program Option for α-syn or Tau and AbbVie elects not to exercise the Collaboration Program Option for (x) Good Reason or (y) Capsida's failure to complete the activities under the Collaborati... |
(b) If AbbVie exercises an Initial Capsid Program Option for either or both of α-syn or Tau and Capsida has completed the activities under the Collaboration Program Research Plan 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... |
3.7.3 Non-Exercise of Ophthalmology Program Options. Subject to Section 8.8: |
(a) If AbbVie does not exercise the Ophthalmology Program Option for a particular Route of Administration, then Capsida shall have the right to Exploit the Ophthalmology Program Capsids (but not the Ophthalmology Research Products) that are the subject of such Ophthalmology Program Option unless such Ophthalmology Prog... |
(b) If AbbVie does not exercise an Ophthalmology Program Option for a Route of Administration, each Party shall either promptly destroy or return to the other Party, at the other Party's election, all Confidential Information of such Party and materials provided to the other Party that relate solely to such Route of Ad... |
ARTICLE 4 DEVELOPMENT |
4.1 Licensed Capsid Products and Licensed Ophthalmology Products. |
4.1.1 General. From and after the exercise by AbbVie of a Capsid Program Option or an Ophthalmology Program Option, as applicable, AbbVie (itself or through its Affiliates or its or their Sublicensees) shall, at its sole cost and expense, assume control of the Exploitation of, and, as between the Parties, shall have th... |
4.1.2 Diligence. AbbVie shall use Commercially Reasonable Efforts to Develop and Commercialize (a) one (1) Licensed Capsid Product for each Licensed Target (other than TDP-43) for one indication in the United States and Major European Markets and (b) one (1) Licensed Ophthalmology Product for each Final Selected Ophtha... |
4.1.3 Reports. From and after the Option Exercise Date for an Initial Capsid Program Option, AbbVie shall, within thirty (30) days after the end of each Calendar Year, provide the JGC for the Neurology Program and Capsida with written progress reports on the status of the Development activities with respect to the Lice... |
4.2 ALS Product. |
4.2.1 General. From and after the exercise by AbbVie of the Collaboration Program Option, subject to Section 4.4 in the case of an ALS Reversion Triggering Event, AbbVie (itself or through its Affiliates or its or their Sublicensees) shall, subject to the terms and conditions of this Agreement and except as otherwise s... |
4.2.2 POC Plan. The initial global Development plan to establish proof of concept for the ALS Product is attached hereto as Exhibit C (the "POC Plan"). Capsida shall, at its sole cost and expense, conduct the POC Plan. The POC Plan shall include (a) any materials to be provided by AbbVie and any activities to be perfor... |
4.2.3 ALS Development Plan and Budget. No later than one year prior to the anticipated completion of the POC Plan, AbbVie, in consultation with and with the reasonable cooperation and support of Capsida, shall prepare a draft global Development plan for the ALS Product and corresponding budget. No later than ninety (90... |
4.2.4 Amendments to POC Plan and ALS Development Plan and Budget. The JGC for the Neurology Program shall review the POC Plan and the ALS Development Plan and Budget annually for the purpose of considering appropriate amendments thereto, and, notwithstanding the foregoing, either Party, through its representatives on s... |
4.2.5 Development Costs. |
(a) Capsida shall bear all Development Costs and other costs and expenses incurred by or on behalf of Capsida under or in connection with the performance of the POC Plan. |
(b) With respect to the ALS Product, Capsida and AbbVie shall each bear fifty percent (50%) of all Development Costs (such Development Costs, the "Co-Development Costs"). |
(c) To the extent that in any Calendar Year Co-Development Costs exceed one hundred ten percent (110%) of the ALS Development Plan and Budget for such Calendar Year, then Capsida shall have the right to defer payment of its fifty percent (50%) share of such excess Co-Development Costs ("Deferred Co-Development Costs");... |
4.2.6 Diligence. From and after the exercise by AbbVie of the Collaboration Program Option, Capsida, and, upon completion of the POC Plan for the ALS Product unless at a meeting of the JGC for the Neurology Program within thirty (30) days of AbbVie's receipt of the Final Data Package resulting from the POC Plan, the JG... |
4.3 ALS Product Regulatory Activities. |
4.3.1 INDs and Related Communications. |
(a) In connection with the POC Plan, Capsida shall have the sole right and responsibility, in reasonable consultation with AbbVie and through the JGC for the Neurology Program, to prepare, obtain and maintain all INDs necessary to perform its obligations under the POC Plan, and to conduct communications with the applic... |
(b) Capsida shall provide drafts of such INDs (including any amendments and supplements thereto) and material communications to AbbVie via the access methods (such as secure databases) mutually agreed by the Parties, for AbbVie's review and comment at least thirty (30) days (or, with respect to Capsida's final draft of... |
For clarity, this Section 4.3.1 shall not in any way prohibit Capsida from complying with its reporting requirements pursuant to Applicable Law, including with respect to adverse event reporting. |
4.3.2 Regulatory Meetings. Capsida shall provide AbbVie with prior written notice, to the extent Capsida has advance knowledge, of any scheduled meeting, conference, or discussion (including any advisory committee meeting) with a Regulatory Authority in the Territory relating to a Research Product containing a Licensed... |
4.3.3 AbbVie Regulatory Responsibilities. Solely with respect to the ALS Product (except with respect to the conduct of the POC Plan): |
(a) AbbVie shall, as between the Parties, have the sole right and responsibility, in reasonable consultation with Capsida, to prepare, obtain and maintain all INDs, Regulatory Approvals and other submissions and to conduct communications with the Regulatory Authorities in the Territory for the ALS Product. Capsida shal... |
(b) AbbVie shall provide Capsida in a timely manner with advance drafts of INDs and Regulatory Approval Applications with respect to the ALS Product and any material amendments or supplements thereto, meet with Capsida to discuss the foregoing, and reasonably consider Capsida's comments which will be provided timely by... |
4.3.4 Post-Option Exercise Regulatory Filings. From and after completion of the POC Plan, all Regulatory Filings (including all Regulatory Approvals) in the Territory with respect to the ALS Product shall be owned by, and shall be the sole property and held in the name of, AbbVie or its designated Affiliate, Sublicense... |
4.4 ALS Reversion Product. |
4.4.1 Development. Notwithstanding anything to the contrary herein, from and after an ALS Reversion Triggering Event, Capsida shall have the sole right, exercisable within ninety (90) days after the ALS Reversion Triggering Event on written notice to AbbVie, to assume at its sole cost and expense, control of the Resear... |
4.4.2 Transition Upon ALS Reversion Triggering Event. Upon AbbVie's receipt of Capsida's notice of its election to assume control of the ALS Reversion Product following an ALS Reversion Triggering Event in accordance with Section 4.4.1, in each case, (i) except as otherwise specified in this Section 4.4.2, (ii) without... |
(a) Manufacture. Upon Capsida's request, AbbVie shall, subject to Section 3.5, use commercially reasonable efforts to assign to Capsida any contract Manufacturing agreements with Third Parties that solely relate to the Manufacture of the ALS Reversion Product to which AbbVie or any of its Affiliates is a party; provide... |
(b) Information; Materials. AbbVie shall transfer to Capsida copies of material data, reports, records, materials (including any assays, reagents, research tools and quantities of the ALS Reversion Product) arising out of the Collaboration Research Program relating to the ALS Reversion Product or any Manufacturing acti... |
(c) Inventory. AbbVie shall provide Capsida with a written summary of all of its inventory of all ALS Reversion Products that were produced, and AbbVie shall, at Capsida's election and cost and expense (including the value of the inventory of ALS Reversion Products), promptly destroy such inventory or deliver such inve... |
(d) Regulatory Documentation. AbbVie shall and hereby does assign to Capsida all of its right, title, and interest in and to all Regulatory Documentation (and as applicable, shall transfer all INDs and other analogous Regulatory Documentation to Capsida) solely relating to the ALS Reversion Product (i.e., that is not a... |
(e) Patent Matters. Without limiting Section 4.4.2(b) and to the extent consistent with Capsida's first right to Prosecute and Maintain the relevant Patents and other provisions under Article 10, AbbVie shall, at Capsida's cost and expense, assist and cooperate with Capsida, as Capsida may reasonably request, in the tr... |
Notwithstanding the foregoing, in no event shall AbbVie be required to disclose, or deliver to Capsida, any information or Know-How that is not, or rights under any inventions that are not claimed by, Reversion IP. |
4.5 Regulatory Support. Without limiting Section 4.3, Capsida shall prepare and provide to AbbVie such Regulatory Documentation with respect to the Capsida Platform, Licensed Capsids, Licensed Ophthalmology Capsids, or the ALS Product as AbbVie may reasonably request from time to time in order for AbbVie obtain and mai... |
4.6 Shared Capsid Safety Information and Use. If Capsida elects to Research, Develop or Commercialize independent of this Agreement (whether itself or with or through an Affiliate or Third Party) any Licensed Capsid or Licensed Ophthalmology Capsid (subject always to Article 8) (any such Licensed Capsid or Licensed Oph... |
4.7 Additional Disclosures to AbbVie. In addition, through regular but not less than quarterly, Patent Working Group meetings, Capsida shall promptly disclose to AbbVie any new inventions that embody any Product-Specific Patents or any material modifications to the Capsida Platform that constitute Capsida Background IP... |
ARTICLE 5 MANUFACTURING |
5.1 Manufacturing Responsibilities Prior to Option Exercise. |
5.1.1 During the conduct of the Research Program and the Ophthalmology Research Program, Capsida shall be solely responsible for the Manufacture and supply of Capsids to support the Research activities under each Research Plan and the Ophthalmology Research Plan, including, as applicable, Reserved Capsids, Reserved Oph... |
5.1.2 The Parties acknowledge that, as of the Original Agreement Effective Date, Capsida has entered into agreements with Third Party manufacturer(s), a true and complete list of which is attached here to as Schedule 5.1.2 (the "Existing CMO Agreements"). To the extent any Existing CMO Agreement is not assignable or su... |
(a) Capsida may freely assign such supply agreement to the extent related to Licensed Products or Licensed Ophthalmology Products to AbbVie after the Option Exercise Date for the applicable Option in accordance with Section 3.4.1 without further consideration; |
(b) Capsida may source supply of the applicable Licensed Capsid, Licensed Product, Licensed Ophthalmology Capsid or Licensed Ophthalmology Product and the components thereof from other suppliers in its sole discretion; and |
(c) upon request by AbbVie, such Third Party manufacturer shall provide AbbVie with such reasonable assistance as is required in order to transfer to AbbVie any Manufacturing Process (including cell banks and biological materials) and related technology used in the Manufacture of such Licensed Capsid, Licensed Product,... |
5.2 Manufacturing After Option Exercise. From and after the Option Exercise Date for a Licensed Product directed to a Target from a Research Stage or a Licensed Ophthalmology Product for a Route of Administration; provided that Capsida has adequate capacity and otherwise satisfies AbbVie's requirements that it customar... |
5.3 Manufacturing Technology Transfer and Continued Improvement. |
5.3.1 Upon one or more of the following: (a) (i) Capsida has not completed the commissioning and qualification of its gene therapy Manufacturing facility and the first engineering run at such facility within twelve (12) months of the Effective Date or (ii) thereafter Capsida fails to satisfy AbbVie's qualification proc... |
5.3.2 If a Supply Transition Event occurs, the Parties shall mutually agree on a technology transfer plan for such Licensed Product or Licensed Ophthalmology Product within thirty (30) days of AbbVie's request (the "Technology Transfer Plan"), which Technology Transfer Plan shall describe the activities to be conducted... |
5.3.3 Capsida shall bear the costs of the Manufacturing Technology Transfer up to Three Thousand (3,000) FTE hours (in the event of a Non-Commercial Supply Transition Event) or One Thousand Five Hundred (1,500) FTE hours (in the event of a Commercial Scale-Up Transition Event) for each Licensed Product or Licensed Opht... |
5.3.4 Subject to the foregoing, Capsida shall provide, shall cause its Affiliates to provide, and shall assist AbbVie in having Third Party manufacturers provide, all reasonable assistance requested by AbbVie to enable AbbVie (or its Affiliate or designated Third Party manufacturer, as applicable) to implement each Man... |
(a) Capsida shall promptly disclose to AbbVie and any applicable Third Party manufacturer any Manufacturing Process Know-How (to the extent not previously disclosed to AbbVie) that (i) relates to the applicable Licensed Product or Licensed Ophthalmology Product, and (ii) if Capsida is not providing clinical supply, als... |
(b) Capsida shall assign to AbbVie all of its right, title and interest in and to, and shall deliver to AbbVie, all cell banks, including any uninfected working cell banks used or developed by or on behalf of Capsida or any of its Affiliates or Third Party manufacturers solely to Manufacture the Licensed Products, Lice... |
(c) Subject to the limitations throughout Section 5.3, Capsida shall cause all appropriate employees and consultants of Capsida and its Affiliates, and shall assist AbbVie in seeking to cause Capsida's Third Party manufacturers, to meet with employees or representatives of AbbVie (or its Affiliate or designated Third P... |
(d) Without limiting the generality of Section 5.3.4(c), Capsida shall cause all appropriate analytical and quality control laboratory employees and consultants of Capsida and its Affiliates as reasonably requested by AbbVie, and shall reasonably assist AbbVie in seeking to cause all appropriate analytical and quality ... |
(e) Capsida shall, and shall cause its Affiliates to, provide, and shall assist AbbVie in seeking to cause its Third Party manufacturers to provide, such other assistance as AbbVie (or its Affiliate or designated Third Party manufacturer(s), as applicable) may reasonably request to enable such Person to use and practic... |
(f) The Parties shall reasonably coordinate the activities with respect to the Manufacturing Technology Transfer to not unreasonably interfere with other activities of either Party. Capsida's obligation to pay the costs and expenses (to the extent set forth in Section 5.3.3) associated with the transfer of each Manufac... |
(g) Except to the extent expressly set forth in this Agreement, Capsida shall have no obligations to transfer to AbbVie any Know-How related to Manufacturing until after the Option Exercise Date and then only in accordance with this Section 5.3 after a Supply Transition Event has occurred. To the extent that Capsida is... |
5.3.5 Capsida acknowledges and agrees that Capsida's obligations under this Section 5.3 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 Section 5.3 by Capsida will result in irreparable injury to... |
ARTICLE 6 COMMERCIALIZATION |
6.1 General. From and after the applicable Option Exercise Date for (i) a Target and a Research Stage, or (ii) for a Route of Administration, as applicable, AbbVie shall assume control of the Exploitation of, and have the exclusive right to Exploit, in respect of (i), Licensed Products containing Licensed Capsids for s... |
6.2 Booking of Sales; Distribution. AbbVie (or its designee(s)) shall have the sole right to invoice and book sales, establish all terms of sale (including pricing and discounts) and warehousing, and distribute the Licensed Products (including Co-Promotion Products) and Licensed Ophthalmology Products in the Territory ... |
6.3 Commercialization of ALS Products. The Parties shall through the JGC for the Neurology Program coordinate the Commercialization of ALS Products in the Territory pursuant to this Section 6.3 and the ALS Commercialization Plan. AbbVie shall be the commercialization lead with operational responsibility for all activit... |
6.3.1 Commercialization Plan. Not later than eighteen (18) months prior to the anticipated date of BLA Filing of the ALS Product in the Territory, AbbVie shall prepare and present to the JGC for the Neurology Program for review and approval a Commercialization plan for the ALS Product that shall set forth the Commercia... |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.