Common use of Manufacturing Technology Transfer Clause in Contracts

Manufacturing Technology Transfer. Upon AbbVie’s written request with respect to a given Collaboration CAR-T Product and Licensed Product, Caribou shall effect a full transfer to AbbVie or its designee (which designee may be an Affiliate or a Third Party Provider) of all Materials and Know-How Controlled by Caribou relating to the then-current process for the Manufacture of such Collaboration CAR-T Product and any corresponding Licensed Products (each, a “Manufacturing Process”). Caribou shall provide, shall cause its Affiliates to provide, and shall use Commercially Reasonable Efforts to assist AbbVie in causing all Third Party Providers to provide, all reasonable assistance requested by AbbVie to enable AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to implement each Manufacturing Process at the facilities designated by AbbVie. If requested by AbbVie, such assistance shall include facilitating the entering into of agreements with applicable Third Party suppliers relating to such Collaboration CAR-T Product and any corresponding Licensed Products. Without limitation of the foregoing, in connection with the Manufacturing Process and related transfer: (a) Caribou shall, and shall cause its Affiliates to, make available to AbbVie (or its Affiliate or designated Third Party Provider, as applicable), and shall use Commercially Reasonable Efforts to assist AbbVie in causing all Third Party Providers to make available to AbbVie, from time to time as AbbVie may request, all Materials and Manufacturing-related Know-How Controlled by Caribou relating to each Manufacturing Process, including methods, reagents and processes and testing/characterization Know-How, and all documentation constituting material support, performance advice, shop practice, standard operating procedures, specifications as to Materials to be used, and control methods, that are necessary or reasonably useful to enable AbbVie (or its Affiliate or designated Third Party manufacturer, as applicable) to use and practice such Manufacturing Process; (b) Caribou shall cause all appropriate employees and representatives of Caribou and its Affiliates, and shall use Commercially Reasonable Efforts to assist AbbVie in causing all appropriate employees and representatives of Third Party Providers, to meet with employees or representatives of AbbVie (or its Affiliate or designated Third Party Provider, as applicable) at the applicable manufacturing facility at mutually convenient times to assist with the working up and use of each Manufacturing Process and with the training of the personnel of AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to the extent necessary or reasonably useful to enable AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to use and practice such Manufacturing Process; (c) Without limiting the generality of this Section 4.4.2, Caribou shall cause all appropriate analytical and quality control laboratory employees and representatives of Caribou and its Affiliates, and shall use Commercially Reasonable Efforts to assist AbbVie in causing all appropriate analytical and quality control laboratory employees and representatives of Third Party Providers, to meet with employees or representatives of AbbVie (or its Affiliate or designated Third Party Provider, as applicable) at the applicable manufacturing facility and make available all necessary equipment, at mutually convenient times, to support and execute the provision of all applicable analytical methods and the validation thereof (including all applicable Know-How, Information and Materials Controlled by Caribou, and sufficient supplies of all primary and other reference standards); (d) Caribou shall, and shall cause its Affiliates to, take such steps, and shall use Commercially Reasonable Efforts to assist AbbVie in causing Third Party Providers take such steps, as are necessary or reasonably useful to assist AbbVie (or its Affiliate or designated Third Party Provider, as applicable) in obtaining any necessary licenses, permits or approvals from Regulatory Authorities with respect to the Manufacture of the applicable Collaboration CAR-T Products and corresponding Licensed Products at the applicable facilities; and (e) Caribou shall, and shall cause its Affiliates to, provide, and shall use Commercially Reasonable Efforts to assist AbbVie in causing Third Party Providers to provide, such other assistance as AbbVie (or its Affiliate or designated Third Party Provider, as applicable) may reasonably request to enable AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to use and practice each Manufacturing Process and otherwise to Manufacture the applicable Collaboration CAR-T Products and corresponding Licensed Products.

Appears in 2 contracts

Sources: Collaboration and License Agreement (Caribou Biosciences, Inc.), Collaboration and License Agreement (Caribou Biosciences, Inc.)

Manufacturing Technology Transfer. Upon AbbVie’s written request with respect Within [***], the Parties will enter into a separate agreement setting forth the terms and conditions under which HUTCHMED will transfer, or have transferred by its contract manufacturing organizations, to a given Collaboration CAR-T Product and Licensed Product, Caribou shall effect a full transfer to AbbVie Company or its designee (which designee may be an Affiliate or a Third Party Provider) of all Materials and designee, the Licensed Know-How Controlled by Caribou relating and materials that are necessary or useful to Manufacture the then-current process for the Manufacture of such Collaboration CAR-T Product Licensed Compound and any corresponding Licensed Products in the Territory (eachthe “HUTCHMED Manufacturing Know-How”), a the terms of which agreement shall include the terms set forth in the Manufacturing Technology Transfer Term Sheet attached hereto as Schedule 4.3.3 (Terms of Manufacturing Technology Transfer) and such other terms and conditions as the Parties shall mutually agree upon (the “Manufacturing ProcessTechnology Transfer Agreement”). Caribou shall provide, shall cause its Affiliates Each Party will use reasonable efforts to provide, and shall use Commercially Reasonable Efforts to assist AbbVie in causing all Third Party Providers to provide, all reasonable assistance requested by AbbVie to enable AbbVie (or its Affiliate or designated Third Party Provider, effect such transfer as applicable) to implement each Manufacturing Process at soon as reasonably practicable following the facilities designated by AbbVie. If requested by AbbVie, such assistance shall include facilitating the Parties entering into the Manufacturing Technology Transfer Agreement regarding such transfer and, in any event, within any timeline contemplated in Schedule 4.3.3 (Terms of agreements with applicable Third Party suppliers relating to such Collaboration CAR-T Product and any corresponding Licensed ProductsManufacturing Technology Transfer). Without limitation of the foregoing, Any materials provided by ▇▇▇▇▇▇▇▇ in connection with the transfer of the HUTCHMED Manufacturing Process Know-How will remain the sole property of HUTCHMED, and related transfer: Company will (a) Caribou shall, and shall cause its Affiliates to, make available to AbbVie (or its Affiliate or designated Third Party Provider, as applicable), and shall use Commercially Reasonable Efforts to assist AbbVie in causing all Third Party Providers to make available to AbbVie, from time to time as AbbVie may request, all Materials and Manufacturing-related Know-How Controlled by Caribou relating to each such HUTCHMED Manufacturing Process, including methods, reagents and processes and testing/characterization Know-How, and all documentation constituting material supportincluding any materials transferred in connection therewith, performance advice, shop practice, standard operating procedures, specifications as to Materials to be usedonly in the fulfillment of obligations or exercise of rights under this ​ Agreement, and control methods, that are necessary or reasonably useful to enable AbbVie (or its Affiliate or designated Third Party manufacturer, as applicable) to use and practice such Manufacturing Process; (b) Caribou shall cause all appropriate employees and representatives of Caribou and its Affiliates, and shall not use Commercially Reasonable Efforts to assist AbbVie in causing all appropriate employees and representatives of Third Party Providers, to meet with employees or representatives of AbbVie (or its Affiliate or designated Third Party Provider, as applicable) at the applicable manufacturing facility at mutually convenient times to assist with the working up and use of each such HUTCHMED Manufacturing Process and with the training of the personnel of AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to the extent necessary or reasonably useful to enable AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to use and practice such Manufacturing Process; (c) Without limiting the generality of this Section 4.4.2, Caribou shall cause all appropriate analytical and quality control laboratory employees and representatives of Caribou and its Affiliates, and shall use Commercially Reasonable Efforts to assist AbbVie in causing all appropriate analytical and quality control laboratory employees and representatives of Third Party Providers, to meet with employees or representatives of AbbVie (or its Affiliate or designated Third Party Provider, as applicable) at the applicable manufacturing facility and make available all necessary equipment, at mutually convenient times, to support and execute the provision of all applicable analytical methods and the validation thereof (including all applicable Know-How, Information including any materials received from HUTCHMED, or deliver the same to any Third Party, other than permitted Sublicensees, Subcontractors and Materials Controlled Third Party consultants solely for the purpose of Manufacturing the Licensed Compound or Licensed Products in the Territory in accordance with this Agreement, without HUTCHMED’s prior written consent. HUTCHMED will provide [***] of HUTCHMED Manufacturing Know-How transfer support free of charge. Within thirty (30) days after the end of each Calendar Quarter, ▇▇▇▇▇▇▇▇ shall deliver a report to Company of the HUTCHMED Manufacturing Know-How transfer support provided pursuant to this Section 4.3.3 (Manufacturing Technology Transfer), which report shall include a description of activities conducted, the number of hours devoted by Cariboueach individual performing such activities (regardless of whether or not 1,800 working hours of transfer support has been provided), a calculation of the actual FTE Costs applicable to each such individual (if applicable pursuant to the immediately following sentence), and sufficient supplies any reasonable out-of-pocket expenses incurred (together with supporting documentation). Company will reimburse HUTCHMED for (x) the FTE Costs in excess of [***] (if any) and (y) all primary and other reference standards); (d) Caribou shallreasonable out-of-pocket costs, charges, and shall cause expenses, in each case clauses (x) and (y), incurred by ▇▇▇▇▇▇▇▇ and its Affiliates toin connection with any HUTCHMED Manufacturing Know-How transfer support. ▇▇▇▇▇▇▇▇ will invoice Company for any costs, take such steps, charges and shall use Commercially Reasonable Efforts to assist AbbVie in causing Third Party Providers take such steps, as are necessary or reasonably useful to assist AbbVie (or its Affiliate or designated Third Party Provider, as applicable) in obtaining any necessary licenses, permits or approvals from Regulatory Authorities with respect expenses payable by Company pursuant to the Manufacture immediately preceding sentence quarterly, and, subject to its receipt of the applicable Collaboration CAR-T Products reports of the transfer support provided by ▇▇▇▇▇▇▇▇ and corresponding Licensed Products at the applicable facilities; and audit rights of Company contemplated in Schedule 4.3.3 (e) Caribou shallTerms of Manufacturing Technology Transfer), and shall cause its Affiliates to, provide, and shall use Commercially Reasonable Efforts to assist AbbVie in causing Third Party Providers to provide, such other assistance as AbbVie (or its Affiliate or designated Third Party Provider, as applicable) may reasonably request to enable AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to use and practice each Manufacturing Process and otherwise to Manufacture Company will pay all invoices submitted by HUTCHMED within [***] of the applicable Collaboration CAR-T Products and corresponding Licensed Productsdate of receipt of the invoice.

Appears in 1 contract

Sources: License Agreement (HUTCHMED (China) LTD)

Manufacturing Technology Transfer. 7.3.1 Upon AbbVie’s written request request, I-Mab shall, and shall cause its Affiliates and shall use Commercially Reasonable Efforts to cause Third Party manufacturers to: (a) with respect to any Existing Product (or component thereof) Manufactured by a given Collaboration CARThird Party manufacturer, and (b) with respect to any Existing Product (or component thereof) Manufactured by I-T Product and Licensed ProductMab, Caribou shall its Affiliates or a Third Party manufacturer, effect a full or partial transfer to AbbVie or its designee (which designee may be an Affiliate or a Third Party Providermanufacturer) of all Materials and I-Mab Know-How Controlled by Caribou and Joint Know-How relating to the then-current process for the Manufacture of such Collaboration CAR-T Existing Product and any corresponding (including the Licensed Products Compound contained therein) (each, a the “Manufacturing Process”) and to implement the Manufacturing Process at facilities designated by AbbVie ((a) and (b) collectively, as more fully described in this Section 7.3, the “Manufacturing Technology Transfer”). Caribou shall provideI-Mab shall, and shall cause its Affiliates to to, provide, and shall use Commercially Reasonable Efforts to assist AbbVie in causing all Third Party Providers manufacturers to provide, all reasonable assistance requested by AbbVie to enable AbbVie (or its Affiliate or designated Third Party Providermanufacturer, as applicable) to implement each the Manufacturing Process at the facilities designated by AbbVie. If requested by AbbVie, such assistance shall include facilitating the entering into of agreements with applicable Third Party suppliers relating to the Existing Product (including the Initial Licensed Compound contained therein). Notwithstanding the foregoing, any such Collaboration CARassistance by a Third Party manufacturer shall be subject to the applicable terms and conditions of the existing agreement between I-T Product Mab and such Third Party manufacturer; provided that, to the extent any corresponding Licensed Productsassistance reasonably requested by AbbVie is not contemplated by the applicable terms and conditions of the existing agreement between I-Mab and such Third Party manufacturer, then at AbbVie’s request and expense, I-Mab will use reasonable efforts to cause, or assist AbbVie to cause, such Third Party manufacturer to provide such assistance to AbbVie. Upon completion of the Manufacturing Technology Transfer, AbbVie shall have the right, in its sole discretion, to make any improvements to the Manufacturing Process. Without limitation of the foregoing, in connection with the Manufacturing Process Technology Transfer and related transferto the extent requested by AbbVie: (a) Caribou 7.3.2 I- Mab shall, and shall cause its Affiliates to, make available available, and, shall assist AbbVie in causing Third Party manufacturers to make available, to AbbVie (or its Affiliate or designated Third Party Providermanufacturer, as applicable), and shall use Commercially Reasonable Efforts to assist AbbVie in causing all Third Party Providers to make available to AbbVie, ) from time to time as AbbVie may request, all Materials and Manufacturing-related I-Mab Know-How Controlled by Caribou and Joint Know-How and all Information and materials relating to each the Manufacturing Process, including methods, reagents and processes and testing/characterization Know-HowInformation, and all documentation constituting material support, performance advice, shop practice, standard operating procedures, specifications as to Materials materials to be used, used and control methods, that are reasonably necessary or reasonably useful to enable AbbVie (or its Affiliate or designated Third Party manufacturer, as applicable) to use and practice such the Manufacturing Process; (b) Caribou shall cause all appropriate employees and representatives of Caribou and its Affiliates, and shall use Commercially Reasonable Efforts to assist AbbVie in causing all appropriate employees and representatives of Third Party Providers, to meet with employees or representatives of AbbVie (or its Affiliate or designated Third Party Provider, as applicable) at the applicable manufacturing facility at mutually convenient times to assist with the working up and use of each Manufacturing Process and with the training of the personnel of AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to the extent necessary or reasonably useful to enable AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to use and practice such Manufacturing Process; (c) Without limiting the generality of this Section 4.4.2, Caribou shall cause all appropriate analytical and quality control laboratory employees and representatives of Caribou and its Affiliates, and shall use Commercially Reasonable Efforts to assist AbbVie in causing all appropriate analytical and quality control laboratory employees and representatives of Third Party Providers, to meet with employees or representatives of AbbVie (or its Affiliate or designated Third Party Provider, as applicable) at the applicable manufacturing facility and make available all necessary equipment, at mutually convenient times, to support and execute the provision of all applicable analytical methods and the validation thereof (including all applicable Know-How, Information and Materials Controlled by Caribou, and sufficient supplies of all primary and other reference standards); (d) Caribou shall, and shall cause its Affiliates to, take such steps, and shall use Commercially Reasonable Efforts to assist AbbVie in causing Third Party Providers take such steps, as are necessary or reasonably useful to assist AbbVie (or its Affiliate or designated Third Party Provider, as applicable) in obtaining any necessary licenses, permits or approvals from Regulatory Authorities with respect to the Manufacture of the applicable Collaboration CAR-T Products and corresponding Licensed Products at the applicable facilities; and (e) Caribou shall, and shall cause its Affiliates to, provide, and shall use Commercially Reasonable Efforts to assist AbbVie in causing Third Party Providers to provide, such other assistance as AbbVie (or its Affiliate or designated Third Party Provider, as applicable) may reasonably request to enable AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to use and practice each Manufacturing Process and otherwise to Manufacture the applicable Collaboration CAR-T Products and corresponding Licensed Products.

Appears in 1 contract

Sources: License and Collaboration Agreement (I-Mab)

Manufacturing Technology Transfer. Upon AbbVieIn addition to Benitec’s written request with respect to a given obligations under Section 2.4 (Transfer of Know-How and Materials for BB-301) and Section 3.7 (Transfer of Know- How and Materials for Collaboration CAR-T Product and Licensed ProductPrograms), Caribou Benitec shall effect a full (itself or through its Affiliate(s)) transfer to AbbVie Axovant or its designee (which designee may all process development work conducted by Benitec as of the Effective Date or during the Term to the extent that it is reasonably necessary or useful for the manufacture of any of Compound or Licensed Product at any time that such work is completed and ready to be an Affiliate transferred, solely for Axovant or a Third Party Provider) its CMO to manufacture or have manufactured Compounds or Licensed Products in accordance with the terms and conditions of all Materials and this Agreement. Such transfer shall include copies of the Benitec Know-How Controlled by Caribou relating to the then-current process and any tangible materials that are necessary for the Manufacture implementation of such Collaboration CARprocess development work in manufacture of Compounds or Licensed Products. Upon Axovant’s reasonable request, Benitec shall (itself or through its Affiliate(s)) provide reasonable technical assistance by making appropriate personnel available to Axovant at reasonable times, places, and frequency, and upon reasonable prior notice for up to an aggregate of [***], which shall be free of charge to Axovant, for the purpose of assisting Axovant to understand and use such Benitec Know-T Product How for the manufacture of Compounds and any corresponding Licensed Products Products. Thereafter, if requested by Axovant, Benitec shall continue to make its personnel available to Axovant and continue to perform such technology transfer obligations, provided that Axovant will reimburse and pay Benitec for its time incurred in performing such technology transfer obligations and providing such assistance at the Benitec FTE Rate. The following costs and fees for the manufacturing and technology transfer assistance described in this Section 6.2 (eachManufacturing Technology Transfer) shall be reimbursed and paid by Axovant pursuant to Section 8.2(b) (Reimbursement of Benitec Manufacturing Technology Transfer Costs): (a) the Out-of-Pocket Costs incurred by Benitec or its Affiliate(s), a and (b) the product of the Benitec FTE Rate multiplied by the number of Benitec FTE hours provided in excess of the above-referenced free [***], in each case of (a) and (b) that are directly related to such technology transfer or assistance (collectively, the Manufacturing ProcessBenitec Technology Transfer Costs”). Caribou The Benitec Technology Transfer Costs shall provide, shall cause its Affiliates to provide, and shall use Commercially Reasonable Efforts to assist AbbVie be reimbursed by Axovant in causing all Third Party Providers to provide, all reasonable assistance requested by AbbVie to enable AbbVie accordance with Section 8.2(b) (or its Affiliate or designated Third Party Provider, as applicable) to implement each Reimbursement of Benitec Manufacturing Process at the facilities designated by AbbVie. If requested by AbbVie, such assistance shall include facilitating the entering into of agreements with applicable Third Party suppliers relating to such Collaboration CAR-T Product and any corresponding Licensed Products. Without limitation of the foregoing, in connection with the Manufacturing Process and related transfer: (a) Caribou shall, and shall cause its Affiliates to, make available to AbbVie (or its Affiliate or designated Third Party Provider, as applicableTechnology Transfer Costs), and shall use Commercially Reasonable Efforts to assist AbbVie in causing all Third Party Providers to make available to AbbVie, from time to time as AbbVie may request, all Materials and Manufacturing-related Know-How Controlled by Caribou relating to each Manufacturing Process, including methods, reagents and processes and testing/characterization Know-How, and all documentation constituting material support, performance advice, shop practice, standard operating procedures, specifications as to Materials to be used, and control methods, that are necessary or reasonably useful to enable AbbVie (or its Affiliate or designated Third Party manufacturer, as applicable) to use and practice such Manufacturing Process; (b) Caribou shall cause all appropriate employees and representatives of Caribou and its Affiliates, and shall use Commercially Reasonable Efforts to assist AbbVie in causing all appropriate employees and representatives of Third Party Providers, to meet with employees or representatives of AbbVie (or its Affiliate or designated Third Party Provider, as applicable) at the applicable manufacturing facility at mutually convenient times to assist with the working up and use of each Manufacturing Process and with the training of the personnel of AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to the extent necessary or reasonably useful to enable AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to use and practice such Manufacturing Process; (c) Without limiting the generality of this Section 4.4.2, Caribou shall cause all appropriate analytical and quality control laboratory employees and representatives of Caribou and its Affiliates, and shall use Commercially Reasonable Efforts to assist AbbVie in causing all appropriate analytical and quality control laboratory employees and representatives of Third Party Providers, to meet with employees or representatives of AbbVie (or its Affiliate or designated Third Party Provider, as applicable) at the applicable manufacturing facility and make available all necessary equipment, at mutually convenient times, to support and execute the provision of all applicable analytical methods and the validation thereof (including all applicable Know-How, Information and Materials Controlled by Caribou, and sufficient supplies of all primary and other reference standards); (d) Caribou shall, and shall cause its Affiliates to, take such steps, and shall use Commercially Reasonable Efforts to assist AbbVie in causing Third Party Providers take such steps, as are necessary or reasonably useful to assist AbbVie (or its Affiliate or designated Third Party Provider, as applicable) in obtaining any necessary licenses, permits or approvals from Regulatory Authorities with respect to the Manufacture of the applicable Collaboration CAR-T Products and corresponding Licensed Products at the applicable facilities; and (e) Caribou shall, and shall cause its Affiliates to, provide, and shall use Commercially Reasonable Efforts to assist AbbVie in causing Third Party Providers to provide, such other assistance as AbbVie (or its Affiliate or designated Third Party Provider, as applicable) may reasonably request to enable AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to use and practice each Manufacturing Process and otherwise to Manufacture the applicable Collaboration CAR-T Products and corresponding Licensed Products.

Appears in 1 contract

Sources: License and Collaboration Agreement (Axovant Sciences Ltd.)

Manufacturing Technology Transfer. Upon AbbVie’s written request with respect to a given Collaboration CAR-T Product and Licensed Product, Caribou shall effect a full transfer to AbbVie or its designee (which designee may be an Affiliate or a Third Party Provider) of all Materials and Know-How Controlled by Caribou relating to the then-current process for the Manufacture of such Collaboration CAR-T Product and any corresponding Licensed Products (each, a “Manufacturing Process”). Caribou shall provide, shall cause its Affiliates to provide, and shall use Commercially Reasonable Efforts to assist AbbVie in causing all Third Party Providers to provide, all reasonable assistance requested by AbbVie to enable AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to implement each Manufacturing Process at the facilities designated by AbbVie. If requested by AbbVie, such assistance shall include facilitating the entering into of agreements with applicable Third Party suppliers relating to such Collaboration CAR-T Product and any corresponding Licensed Products. Without limitation of the foregoing, in connection with the Manufacturing Process and related transfer: (a) Caribou Jemincare shall, and shall cause its Affiliates to, make available transfer to AbbVie [***] Manufacturing Technology Receiving Entity, at RAPT’s sole cost and expense pursuant to Section 5.3.3 (or its Affiliate or designated Third Party Provider, as applicableJemincare Assistance), all Manufacturing technology, processes, specifications, and shall use Commercially Reasonable Efforts to assist AbbVie in causing all Third Party Providers to make available to AbbVie, from time to time as AbbVie may request, all Manufacturing Materials and Manufacturing-related all associated Know-How Controlled by Caribou relating to each Manufacturing Process, including methods, reagents and processes and testing/characterization Know-How, and all documentation constituting material support, performance advice, shop practice, standard operating procedures, specifications as to Materials to be used, and control methods, that are necessary or reasonably useful to enable AbbVie (or its Affiliate or designated Third Party manufacturer, as applicable) to use Manufacture clinical and practice such commercial quantities of Licensed Products for the RAPT Territory using the [***] Manufacturing Process; (b) Caribou shall cause all appropriate employees and representatives of Caribou and its Affiliates, and shall use Commercially Reasonable Efforts to assist AbbVie in causing all appropriate employees and representatives of Third Party Providers, to meet with employees or representatives of AbbVie (or its Affiliate or designated Third Party Provider, as applicable) Process that are existing at the applicable manufacturing facility at mutually convenient times to assist time the [***] Manufacturing Process is first established by Jemincare (the “Manufacturing Technology Transfer”) in accordance with the working up and use of each Manufacturing Process and with technology transfer plan set forth in Schedule 5.3.2 (Manufacturing Technology Transfer Plan), including the training of timelines set forth therein (the personnel of AbbVie “Manufacturing Technology Transfer Plan”). Subject to Section 5.3.3 (or its Affiliate or designated Third Party ProviderJemincare CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, as applicableMARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) to the extent necessary or reasonably useful to enable AbbVie NOT MATERIAL AND (or its Affiliate or designated Third Party ProviderII) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL. Assistance), as applicable) to use and practice such Manufacturing Process; (c) Without limiting the generality of this Section 4.4.2, Caribou shall cause all appropriate analytical and quality control laboratory employees and representatives of Caribou and its Affiliates, and shall use Commercially Reasonable Efforts to assist AbbVie in causing all appropriate analytical and quality control laboratory employees and representatives of Third Party Providers, to meet with employees or representatives of AbbVie (or its Affiliate or designated Third Party Provider, as applicable) at the applicable manufacturing facility and make available all necessary equipment, at mutually convenient times, to support and execute the provision of all applicable analytical methods and the validation thereof (including all applicable Know-How, Information and Materials Controlled by Caribou, and sufficient supplies of all primary and other reference standards); (d) Caribou Jemincare shall, and shall cause its Affiliates or Jemincare CMOs to, take such stepsprovide all reasonable assistance requested by RAPT on an ongoing basis, to enable the Manufacturing Technology Receiving Entity to achieve Successful Completion of Manufacturing Technology Transfer. The Parties shall start the Manufacturing Technology Transfer in accordance with the timelines set forth in the Manufacturing Technology Transfer Plan, and each Party shall use Commercially Reasonable Efforts to assist AbbVie achieve Successful Completion of Manufacturing Technology Transfer within the timelines set forth in causing Third Party Providers take such steps, as are necessary or reasonably useful to assist AbbVie (or its Affiliate or designated Third Party Provider, as applicable) in obtaining any necessary licenses, permits or approvals from Regulatory Authorities with respect to the Manufacture of the applicable Collaboration CAR-T Products and corresponding Licensed Products at the applicable facilities; andManufacturing Technology Transfer Plan [***]. [***]. (eb) Caribou Without limiting Section 5.3.2(a), Jemincare shall, and shall cause its Affiliates and Jemincare CMOs to, provide, transfer to the Manufacturing Technology Receiving Entity the Master Cell Bank and shall use Commercially Reasonable Efforts to assist AbbVie the Working Cell Bank in causing Third Party Providers to provide, such other assistance as AbbVie (or its Affiliate or designated Third Party Provider, as applicable) may reasonably request to enable AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to use and practice each accordance with the Manufacturing Process and otherwise to Manufacture the applicable Collaboration CAR-T Products and corresponding Licensed ProductsTechnology Transfer Plan.

Appears in 1 contract

Sources: License Agreement (RAPT Therapeutics, Inc.)

Manufacturing Technology Transfer. (a) Upon AbbVie’s written request with respect to a given Collaboration CAR-T Product and Licensed Productby Qilu made after receipt by Arbutus of the Upfront Payment, Caribou shall effect a full transfer to AbbVie or its designee (which designee may be an Affiliate or a Third Party Provider) of all Materials and Know-How Controlled by Caribou relating to the then-current process for the Manufacture of such Collaboration CAR-T Product and any corresponding Licensed Products (each, a “Manufacturing Process”). Caribou shall provide, shall cause its Affiliates to provideArbutus shall, and shall use Commercially Reasonable Efforts to assist AbbVie cause its CMO(s) to, commence the Manufacturing technology transfer (the “Manufacturing Technology Transfer”) to Qilu or its permitted CMO or permitted Sublicensees in causing all Third Party Providers accordance with a manufacturing technology transfer plan (“Manufacturing Technology Transfer Plan”) to providebe negotiated in good faith and entered into by the Parties, all reasonable assistance requested which shall set forth the process by AbbVie which Arbutus shall transfer to enable AbbVie Qilu (or its Affiliate permitted CMO or designated permitted Sublicensees) all of the Arbutus IP that is necessary or reasonably useful for the Manufacturing of the Licensed Compound and Licensed Products (“Manufacturing Technology”). In addition to the Manufacturing Technology Transfer, Arbutus shall provide reasonable technical assistance and support for Qilu to Manufacture or have Manufactured the Licensed Compound and Licensed Products until Manufacturing Technology Transfer Completion in accordance with the terms of this Section 5.5(a) (“Technical Assistance”). Arbutus and Qilu shall each use Commercially Reasonable Efforts to perform their respective obligations necessary to achieve Manufacturing Technology Transfer Completion as soon as reasonably possible. Qilu shall be responsible for reimbursing Arbutus for any out-of-pocket costs, including any fees charged by any CMO or other Third Party Providerservice provider, required to perform the Manufacturing Technology Transfer or the Technical Assistance, to the extent not otherwise reimbursed under this Agreement. Upon the request of Qilu, Arbutus shall provide the Technical Assistance to Qilu, subject to the following terms and conditions: (1) the Technical Assistance shall not require any Arbutus employee to travel in-person to the Territory (except as applicablemay be agreed by the Parties otherwise, in which case, the Parties shall also agree on the specific travel arrangements and Qilu’s responsibility for the costs therefor); (2) to implement each Manufacturing Process at the facilities designated by AbbVie. If requested by AbbVie, such assistance Technical Assistance shall include facilitating the entering into of agreements with applicable Third Party suppliers relating time spent by Arbutus employees to such Collaboration CAR-T Product and oversee any corresponding Licensed Products. Without limitation of the foregoing, activities in connection with the Manufacturing Process Technology Transfer and related transfer: (a) Caribou shall, and shall cause its Affiliates to, make available to AbbVie (the Technical Assistance provided by any CMO or its Affiliate or designated other Third Party Providerservice provider; (3) [***]; and (4) [***](the “Technical Assistance Cap”). If Qilu requires Technical Assistance in excess of the Technical Assistance Cap, as applicableArbutus agrees not to unreasonably withhold its agreement CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY “[***]”, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL to provide such additional Technical Assistance. Within thirty (30) days after the end of each Calendar Quarter when the Manufacturing Technology Transfer is ongoing or the Technical Assistance is provided, Arbutus shall deliver to Qilu an invoice setting forth the number of hours of Technical Assistance provided during the prior Calendar Quarter and the amounts owed to Arbutus with respect thereto, including any out-of-pocket costs to be paid by Qilu, together with any out-of-pocket costs incurred by Arbutus in connection with the Manufacturing Technology Transfer to be paid by Qilu, in each case to the extent not otherwise reimbursed or paid for by Qilu under this Agreement. Each such invoice shall be paid by Qilu within thirty (30) days of the date of such invoice and otherwise in accordance with Sections 7.5(g), 7.5(h) and shall use Commercially Reasonable Efforts to assist AbbVie in causing all Third Party Providers to make available to AbbVie, from time to time as AbbVie may request, all Materials and Manufacturing-related Know-How Controlled by Caribou relating to each Manufacturing Process, including methods, reagents and processes and testing/characterization Know-How, and all documentation constituting material support, performance advice, shop practice, standard operating procedures, specifications as to Materials to be used, and control methods, that are necessary or reasonably useful to enable AbbVie (or its Affiliate or designated Third Party manufacturer, as applicable) to use and practice such Manufacturing Process;7.6. (b) Caribou shall cause all appropriate employees After the Supply End Date, Qilu will have the right and representatives of Caribou and its Affiliates, and shall use Commercially Reasonable Efforts responsibility to assist AbbVie Manufacture or have Manufactured Licensed Product in causing all appropriate employees and representatives of Third Party Providers, to meet with employees the Territory for clinical or representatives of AbbVie (or its Affiliate or designated Third Party Providercommercial use, as applicable) at the applicable manufacturing facility at mutually convenient times to assist with case may be, using the working up and use of each Manufacturing Process and with Technology transferred under the training of the personnel of AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to the extent necessary or reasonably useful to enable AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to use and practice such Manufacturing Process;Technology Transfer Plan. (c) Without limiting the generality If there is any additional Arbutus Know-How pertaining to Manufacturing Technology that comes into Arbutus’ or any of this Section 4.4.2, Caribou shall cause all appropriate analytical and quality control laboratory employees and representatives of Caribou and its Affiliates, and shall use Commercially Reasonable Efforts to assist AbbVie in causing all appropriate analytical and quality control laboratory employees and representatives of Third Party Providers, to meet with employees or representatives of AbbVie (or its Affiliate or designated Third Party Provider, as applicable) at ’ Control during the applicable manufacturing facility and make available all necessary equipment, at mutually convenient times, to support and execute the provision of all applicable analytical methods and the validation thereof Term after Manufacturing Technology Transfer Completion (including all applicable Know-How, Information and Materials Controlled by Caribou, and sufficient supplies of all primary and other reference standards); (d) Caribou shall, and shall cause its Affiliates to, take such steps, and shall use Commercially Reasonable Efforts to assist AbbVie in causing Third Party Providers take such steps, as are necessary or reasonably useful to assist AbbVie (or its Affiliate or designated Third Party Provider, as applicable) in obtaining any necessary licenses, permits or approvals data resulting from Regulatory Authorities with respect to the Manufacture of the applicable Collaboration CAR-T Products and corresponding Licensed Products in the ROW Territory after the Manufacturing Technology Transfer Completion), Arbutus shall promptly notify Qilu and provide copies thereof to Qilu in accordance with Section 2.5 at the applicable facilities; and (e) Caribou shall, and shall cause its Affiliates to, provide, and shall use Commercially Reasonable Efforts to assist AbbVie in causing Third Party Providers to provide, such other assistance as AbbVie (or its Affiliate or designated Third Party Provider, as applicable) may reasonably request to enable AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to use and practice each Manufacturing Process and otherwise to Manufacture the applicable Collaboration CAR-T Products and corresponding Licensed Productsno additional cost.

Appears in 1 contract

Sources: Technology Transfer and Exclusive License Agreement (Arbutus Biopharma Corp)

Manufacturing Technology Transfer. Upon AbbViePromptly after the Second Amendment Effective Date, the Parties shall coordinate the logistics of initiation and completion of a technology transfer of the process and technology that is then-used to manufacture the Product (including, for clarity, Breaking Tools) to Licensee or its CMO (the “Manufacturing Technology Transfer”), which shall be performed in accordance with a mutually agreed technology transfer plan. As part of the Manufacturing Technology Transfer, Verrica shall (a) make available to Licensee (or its designee) any and all copies of Verrica Know-How, to the extent not previously provided to Licensee, that is necessary or reasonably useful for Licensee to practice the Manufacturing License; and (b) provide Licensee (or its designee) with reasonable technical assistance (which may include reasonable access to Verrica’s written request with respect technical personnel involved in the manufacture of the Product) to a given Collaboration CAR-T enable Licensee (or its designee) to manufacture the Product and Licensed Productcomponents thereof. In addition, Caribou upon Licensee’s request, Verrica shall effect a full transfer to AbbVie or its designee (which designee may be an Affiliate or a Third Party Provider) of all Materials and Know-How Controlled by Caribou relating introduce Licensee to the then-current process for the Manufacture of such Collaboration CAR-T Product relevant Verrica CMOs and any corresponding Licensed Products (each, a “Manufacturing Process”). Caribou shall provide, shall cause its Affiliates to provide, and shall use Commercially Reasonable Efforts to assist AbbVie in causing all Third Party Providers facilitate the direct discussions between Licensee and the relevant Verrica CMOs so that Licensee may be able to provide, all reasonable assistance requested directly engage such CMOs to manufacture and supply the Product or components thereof. Licensee shall reimburse Verrica for both out- of-pocket cost and internal cost incurred by AbbVie Verrica to enable AbbVie provide the Manufacturing Technology Transfer. The Manufacturing Technology Transfer shall be deemed completed when Licensee (or its Affiliate or designated Third Party Providerdesignee, as applicableincluding CMOs engaged by Licensee) is able to implement each Manufacturing Process at perform, and has in fact commenced performing, the facilities designated by AbbVie. If requested by AbbViefull range of manufacturing operations required to produce the Product, such assistance shall include facilitating including the entering into of agreements with applicable Third Party suppliers relating to such Collaboration CAR-T Product and any corresponding Licensed Products. Without limitation preparation of the foregoingbulk drug product solution, the packaging of bulk solution into ampules and the assembly of the Applicators, but excluding the manufacture of the active pharmaceutical ingredient. In connection with the Manufacturing Technology Transfer, Verrica shall also cooperate and shall cause its CMOs to cooperate, with Licensee in filing necessary regulatory filings in connection with the Manufacturing Process and related transfer: (a) Caribou shall, and shall cause its Affiliates to, make available to AbbVie (or its Affiliate or designated Third Party Provider, as applicable), and shall use Commercially Reasonable Efforts to assist AbbVie in causing all Third Party Providers to make available to AbbVie, from time to time as AbbVie may request, all Materials and Manufacturing-related Know-How Controlled by Caribou relating to each Manufacturing Process, including methods, reagents and processes and testing/characterization Know-How, and all documentation constituting material support, performance advice, shop practice, standard operating procedures, specifications as to Materials to be used, and control methods, that are necessary or reasonably useful to enable AbbVie (or its Affiliate or designated Third Party manufacturer, as applicable) to use and practice such Manufacturing Process; (b) Caribou shall cause all appropriate employees and representatives change of Caribou and its Affiliates, and shall use Commercially Reasonable Efforts to assist AbbVie in causing all appropriate employees and representatives of Third Party Providers, to meet with employees or representatives of AbbVie (or its Affiliate or designated Third Party Provider, as applicable) at the applicable manufacturing facility at mutually convenient times to assist with the working up Licensee’s costs and use of each Manufacturing Process and with the training of the personnel of AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to the extent necessary or reasonably useful to enable AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to use and practice such Manufacturing Process; (c) Without limiting the generality of this Section 4.4.2, Caribou shall cause all appropriate analytical and quality control laboratory employees and representatives of Caribou and its Affiliates, and expenses. Both Parties shall use Commercially Reasonable Efforts best efforts to assist AbbVie in causing all appropriate analytical and quality control laboratory employees and representatives of Third Party Providers, to meet with employees or representatives of AbbVie (or its Affiliate or designated Third Party Provider, complete the Manufacturing Technology Transfer as applicable) at the applicable manufacturing facility and make available all necessary equipment, at mutually convenient times, to support and execute the provision of all applicable analytical methods and the validation thereof (including all applicable Know-How, Information and Materials Controlled by Caribou, and sufficient supplies of all primary and other reference standards); (d) Caribou shall, and shall cause its Affiliates to, take such steps, and shall use Commercially Reasonable Efforts to assist AbbVie in causing Third Party Providers take such steps, quickly as are necessary or reasonably useful to assist AbbVie (or its Affiliate or designated Third Party Provider, as applicable) in obtaining any necessary licenses, permits or approvals from Regulatory Authorities with respect to the Manufacture of the applicable Collaboration CAR-T Products and corresponding Licensed Products at the applicable facilities; and (e) Caribou shall, and shall cause its Affiliates to, provide, and shall use Commercially Reasonable Efforts to assist AbbVie in causing Third Party Providers to provide, such other assistance as AbbVie (or its Affiliate or designated Third Party Provider, as applicable) may reasonably request to enable AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to use and practice each Manufacturing Process and otherwise to Manufacture the applicable Collaboration CAR-T Products and corresponding Licensed Productspossible.

Appears in 1 contract

Sources: Collaboration and License Agreement (Verrica Pharmaceuticals Inc.)

Manufacturing Technology Transfer. Upon AbbVieIn addition to Benitec’s written request with respect to a given obligations under Section 2.4 (Transfer of Know-How and Materials for BB-301) and Section 3.7 (Transfer of Know- How and Materials for Collaboration CAR-T Product and Licensed ProductPrograms), Caribou Benitec shall effect a full (itself or through its Affiliate(s)) transfer to AbbVie Axovant or its designee (which designee may all process development work conducted by Benitec as of the Effective Date or during the Term to the extent that it is reasonably necessary or useful for the manufacture of any of Compound or Licensed Product at any time that such work is completed and ready to be an Affiliate transferred, solely for Axovant or a Third Party Provider) its CMO to manufacture or have manufactured Compounds or Licensed Products in accordance with the terms and conditions of all Materials and this Agreement. Such transfer shall include copies of the Benitec Know-How Controlled by Caribou relating to the then-current process and any tangible materials that are necessary for the Manufacture implementation of such Collaboration CARprocess development work in manufacture of Compounds or Licensed Products. Upon Axovant’s reasonable request, Benitec shall (itself or through its Affiliate(s)) provide reasonable technical assistance by making appropriate personnel available to Axovant at reasonable times, places, and frequency, and upon reasonable prior notice for up to an aggregate of ****, which shall be free of charge to Axovant, for the purpose of assisting Axovant to understand and use such Benitec Know-T Product How for the manufacture of Compounds and any corresponding Licensed Products Products. Thereafter, if requested by Axovant, Benitec shall continue to make its personnel available to Axovant and continue to perform such technology transfer obligations, provided that Axovant will reimburse and pay Benitec for its time incurred in performing such technology transfer obligations and providing such assistance at the Benitec FTE Rate. The following costs and fees for the manufacturing and technology transfer assistance described in this Section 6.2 (eachManufacturing Technology Transfer) shall be reimbursed and paid by Axovant pursuant to Section 8.2(b) (Reimbursement of Benitec Manufacturing Technology Transfer Costs): (a) the Out-of-Pocket Costs incurred by Benitec or its Affiliate(s), a and (b) the product of the Benitec FTE Rate multiplied by the number of Benitec FTE hours provided in excess of the above-referenced free ****, in each case of (a) and (b) that are directly related to such technology transfer or assistance (collectively, the Manufacturing ProcessBenitec Technology Transfer Costs”). Caribou The Benitec Technology Transfer Costs shall provide, shall cause its Affiliates to provide, and shall use Commercially Reasonable Efforts to assist AbbVie be reimbursed by Axovant in causing all Third Party Providers to provide, all reasonable assistance requested by AbbVie to enable AbbVie accordance with Section 8.2(b) (or its Affiliate or designated Third Party Provider, as applicable) to implement each Reimbursement of Benitec Manufacturing Process at the facilities designated by AbbVie. If requested by AbbVie, such assistance shall include facilitating the entering into of agreements with applicable Third Party suppliers relating to such Collaboration CAR-T Product and any corresponding Licensed Products. Without limitation of the foregoing, in connection with the Manufacturing Process and related transfer: (a) Caribou shall, and shall cause its Affiliates to, make available to AbbVie (or its Affiliate or designated Third Party Provider, as applicableTechnology Transfer Costs), and shall use Commercially Reasonable Efforts to assist AbbVie in causing all Third Party Providers to make available to AbbVie, from time to time as AbbVie may request, all Materials and Manufacturing-related Know-How Controlled by Caribou relating to each Manufacturing Process, including methods, reagents and processes and testing/characterization Know-How, and all documentation constituting material support, performance advice, shop practice, standard operating procedures, specifications as to Materials to be used, and control methods, that are necessary or reasonably useful to enable AbbVie (or its Affiliate or designated Third Party manufacturer, as applicable) to use and practice such Manufacturing Process; (b) Caribou shall cause all appropriate employees and representatives of Caribou and its Affiliates, and shall use Commercially Reasonable Efforts to assist AbbVie in causing all appropriate employees and representatives of Third Party Providers, to meet with employees or representatives of AbbVie (or its Affiliate or designated Third Party Provider, as applicable) at the applicable manufacturing facility at mutually convenient times to assist with the working up and use of each Manufacturing Process and with the training of the personnel of AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to the extent necessary or reasonably useful to enable AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to use and practice such Manufacturing Process; (c) Without limiting the generality of this Section 4.4.2, Caribou shall cause all appropriate analytical and quality control laboratory employees and representatives of Caribou and its Affiliates, and shall use Commercially Reasonable Efforts to assist AbbVie in causing all appropriate analytical and quality control laboratory employees and representatives of Third Party Providers, to meet with employees or representatives of AbbVie (or its Affiliate or designated Third Party Provider, as applicable) at the applicable manufacturing facility and make available all necessary equipment, at mutually convenient times, to support and execute the provision of all applicable analytical methods and the validation thereof (including all applicable Know-How, Information and Materials Controlled by Caribou, and sufficient supplies of all primary and other reference standards); (d) Caribou shall, and shall cause its Affiliates to, take such steps, and shall use Commercially Reasonable Efforts to assist AbbVie in causing Third Party Providers take such steps, as are necessary or reasonably useful to assist AbbVie (or its Affiliate or designated Third Party Provider, as applicable) in obtaining any necessary licenses, permits or approvals from Regulatory Authorities with respect to the Manufacture of the applicable Collaboration CAR-T Products and corresponding Licensed Products at the applicable facilities; and (e) Caribou shall, and shall cause its Affiliates to, provide, and shall use Commercially Reasonable Efforts to assist AbbVie in causing Third Party Providers to provide, such other assistance as AbbVie (or its Affiliate or designated Third Party Provider, as applicable) may reasonably request to enable AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to use and practice each Manufacturing Process and otherwise to Manufacture the applicable Collaboration CAR-T Products and corresponding Licensed Products.

Appears in 1 contract

Sources: License and Collaboration Agreement (Benitec Biopharma LTD/ADR)

Manufacturing Technology Transfer. Upon AbbVie(a) Effective as of the Closing, Seller, on its own behalf and on behalf of its Affiliates, hereby grants to Buyer and its Affiliates an exclusive (except to the limited extent required for Seller to perform its obligations under the Manufacturing Agreement), perpetual, irrevocable ([***]), royalty-free, worldwide, and transferable right and license, with a right to grant sublicenses through multiple tiers, under all Know-How and Information owned or Controlled by Seller or any of its Affiliates relating to the Manufacture of the Compound or any Product (the “Licensed Manufacturing Know-How”) solely to Manufacture the Compound or any Product. The Licensed Manufacturing Know-How, as of the date of this Agreement, is listed on Schedule 7.9(a). (b) In connection with Buyer’s written request with respect to a given Collaboration CAR-T Product exercise of the Option, when and Licensed Productas requested by Buyer, Caribou Seller shall, and shall effect a full cause its Affiliates to, transfer to AbbVie Buyer or its designee (which designee may be an Affiliate or a Third Party Provider) of all Materials and Licensed Manufacturing Know-How Controlled How, including by Caribou providing Buyer with: (a) all Books and Records reflecting the Licensed Manufacturing Know-How, including all documentation relating to the then-current process for the Manufacture of such Collaboration CAR-T the Compound or any Product and any corresponding Licensed Products improvements or enhancements to such processes which have been made but not yet implemented; and (each, a “Manufacturing Process”). Caribou shall provide, shall cause its Affiliates to provide, and shall use Commercially Reasonable Efforts to assist AbbVie in causing all Third Party Providers to provide, b) all reasonable assistance requested by AbbVie to enable AbbVie (Buyer or its Affiliate or designated Third Party Provider, as applicable) designee to implement each the Manufacturing Process process at the facilities designated by AbbVie. If requested by AbbVie, Buyer; provided that such assistance shall include facilitating cease on the entering date [***]. In order to facilitate such transfer, Seller and its applicable Affiliates shall (i) participate in a reasonable number of meetings (including video-conference and in person meetings) between the Parties’ experts in the critical aspects of the execution of such technology transfer; (ii) participate in a reasonable number of post-meeting consultations among the Parties’ experts via phone or video-conference; and (iii) facilitate, at Buyer’s expense, ▇▇▇▇▇’s entry into of applicable agreements with applicable any Third Party suppliers who perform any Manufacturing or contracted activities relating to such Collaboration CAR-T the Compound or any Product and for Seller or any corresponding Licensed Products. Without limitation of its Affiliates as of the foregoingClosing Date. Except as expressly provided herein, each Party shall bear its own costs and expenses in connection with any transfer made pursuant to this Section 7.9; provided that, with respect to Seller’s costs and expenses incurred under clause (b) of the Manufacturing Process immediately preceding sentence, the first [***] of activities and related transfer: support shall be at Seller’s cost and expense and thereafter shall be at Buyer’s cost and expense (a) Caribou shall, with Buyer’s cost and expense being equal to [***]). Buyer shall and shall cause its Affiliates to, make available to AbbVie (or its Affiliate or designated Third Party Provider, as applicable), and shall use Commercially Reasonable Efforts commercially reasonable efforts to assist AbbVie in causing cause Payment Obligors and other sublicensees to maintain the confidentiality of all Third Party Providers to make available to AbbVie, from time to time as AbbVie may request, all Materials and Manufacturing-related Licensed Manufacturing Know-How Controlled by Caribou relating and to each use such Licensed Manufacturing Process, including methods, reagents and processes and testing/characterization Know-How, and all documentation constituting material support, performance advice, shop practice, standard operating procedures, specifications as to Materials to be used, and control methods, that are necessary How solely in connection with Manufacturing the Compound or reasonably useful to enable AbbVie (or its Affiliate or designated Third Party manufacturer, as applicable) to use and practice such Manufacturing Process; (b) Caribou shall cause all appropriate employees and representatives of Caribou and its Affiliates, and shall use Commercially Reasonable Efforts to assist AbbVie in causing all appropriate employees and representatives of Third Party Providers, to meet with employees or representatives of AbbVie (or its Affiliate or designated Third Party Provider, as applicable) at the applicable manufacturing facility at mutually convenient times to assist with the working up and use of each Manufacturing Process and with the training of the personnel of AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to the extent necessary or reasonably useful to enable AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to use and practice such Manufacturing Process; (c) Without limiting the generality of this Section 4.4.2, Caribou shall cause all appropriate analytical and quality control laboratory employees and representatives of Caribou and its Affiliates, and shall use Commercially Reasonable Efforts to assist AbbVie in causing all appropriate analytical and quality control laboratory employees and representatives of Third Party Providers, to meet with employees or representatives of AbbVie (or its Affiliate or designated Third Party Provider, as applicable) at the applicable manufacturing facility and make available all necessary equipment, at mutually convenient times, to support and execute the provision of all applicable analytical methods and the validation thereof (including all applicable Know-How, Information and Materials Controlled by Caribou, and sufficient supplies of all primary and other reference standards); (d) Caribou shall, and shall cause its Affiliates to, take such steps, and shall use Commercially Reasonable Efforts to assist AbbVie in causing Third Party Providers take such steps, as are necessary or reasonably useful to assist AbbVie (or its Affiliate or designated Third Party Provider, as applicable) in obtaining any necessary licenses, permits or approvals from Regulatory Authorities with respect to the Manufacture of the applicable Collaboration CAR-T Products and corresponding Licensed Products at the applicable facilities; and (e) Caribou shall, and shall cause its Affiliates to, provide, and shall use Commercially Reasonable Efforts to assist AbbVie in causing Third Party Providers to provide, such other assistance as AbbVie (or its Affiliate or designated Third Party Provider, as applicable) may reasonably request to enable AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to use and practice each Manufacturing Process and otherwise to Manufacture the applicable Collaboration CAR-T Products and corresponding Licensed ProductsProduct.

Appears in 1 contract

Sources: Option and Asset Purchase Agreement (Fusion Pharmaceuticals Inc.)