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Manufacturing
Manufacturing contract clause examples
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Manufacturing. All actual […​…] manufacturing the Selected Compounds will be paid […​…]. Subject to the terms and conditions of this Agreement, [[Firmenich:Organization]] may, in its sole discretion, […​…] with a third party regarding Selected Compounds.

Manufacturing License. Subject to the terms and conditions of this Agreement (including ARTICLE 9), upon and as of the Exercise Effective Date for a Licensed Collaboration Candidate and for the remainder of the Term for such Licensed Collaboration Candidate, Janssen hereby grants to Fate a co-exclusive (with Janssen), non-transferable (except as provided in [Section 17.4]) license (or sublicense, as applicable), with the right to grant sublicenses solely in accordance with Section 5.5 and [Section 9.10], under the Janssen Product Patents and Janssen Product Know-How solely to: # Manufacture and have Manufactured such Licensed Collaboration Candidate and Licensed Products containing such Licensed Collaboration Candidate in the Field in the Territory and # use Master iPSC Banks and [[Unknown Identifier]] Compositions corresponding to such Licensed Collaboration Candidate for the Manufacture of such Licensed Collaboration Candidate and Licensed Products containing such Licensed Collaboration Candidate in the Field in the Territory.

Patheon will perform the Manufacturing Services as set out in the relevant Product Agreement for the Price and in accordance with the Quality Agreement. Patheon agrees to provide all Manufacturing Services promptly and timely and in accordance with prevailing industry standards and practices for the performance of similar services. For each Product Agreement, Patheon will designate a “Project Leader” who will be available for frequent communications with Client regarding the Manufacturing Services provided or to be provided under that Product Agreement. Client will designate a “Representative” who will be the point of contact for the Project Leader. Client may replace their Representative at any time upon written notice to Patheon. Patheon may replace their Project Leader at any time upon written notice to Client. Client may, at any time, request that Patheon replace the Project Leader, which request will be considered in good faith. Subject to the foregoing, Patheon will convert DS and Components into Product, and provide supportive Manufacturing Services such as quality assurance (for example quality controls, analytical testing, and stability programs), primary and secondary packaging, and any other related Manufacturing Services as agreed between the parties.

In addition to the funding provided by Atara for the ​ Programs set forth in Section 2.6, Atara paid to Institute a one-off lump-sum payment of ​ (the “[***] Payment”), which was used by Institute for ​ (the “[***] Capacity”). The ​ Capacity shall be used by Institute to provide manufacturing and related services to support activities under all Programs included within the Development Plan, including the ​ Programs and any other New Research Programs that may be added to this Agreement from time to time.

Patheon will perform the Manufacturing Services for the Territory for the fees specified in a Product Agreement in [Schedules B] and C to manufacture Products for Client or its Affiliate (which shall mean that either Client or its Affiliate would enter into a Product Agreement with Patheon). [Schedule B] to a Product Agreement sets forth a list of cost items that are included in the Price for Products; all cost items that are not included in the Price are subject to additional fees to be paid by the Client. Amendments to the fees set out in [Schedules B] and C to a Product Agreement will be performed in accordance with the price adjustment mechanisms as set forth in Article 4. Patheon may change the Manufacturing Site for the Products only with the prior written consent of Client. In performing the Manufacturing Services, Patheon and Client agree that:

Subcontractor: Patheon Italia SpA. Address: 2 Trav. SX, Via Morolense 5, 03013, Ferentino, Italy

Patheon will perform the Manufacturing Services as set out in the relevant Product Agreement for the Price and in accordance with the Quality Agreement. Subject to the preceding sentence, Patheon will convert API and Components into Product, and provide supportive Manufacturing Services such as quality assurance (for example quality controls, analytical testing, and stability programs), primary and secondary packaging, and any other related Manufacturing Services as agreed between the parties.

Manufacturing Records. Each Party shall promptly provide the other Party, upon its reasonable request for the purpose of this Agreement, copies of the Manufacturing records (including specifications, protocols, batch records, master batch records and other CMC Information) maintained by the first Party, its Affiliates or Third Party contractors pertaining to Compounds and Collaboration Products for such other Party’s use in connection with the Manufacture of the Compounds and/or Collaboration Products under this Agreement (and in the case of [ * ]). Each Party hereby grants the other Party the right to reference (and have referenced by its contract manufacturer) the Drug Master Files, if any, maintained by the first Party, its Affiliates or Third Party contractors pertaining to Compounds

Manufacturing Agreement. The Parties agree to cause the Manufacturing Agreement to remain in full force and effect after the date of this Agreement until the Closing Date.

Manufacturing Services. Manufacturer shall perform, for the Fees as specified in [Section 3.1], Manufacturing Services for Supplied Product to be incorporated by or on behalf of Acorda into Marketed Product for marketing, distribution, and sale of such Marketed Product by Acorda or its Affiliates in the Territory.

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