Manufacture. Without limiting Genentech’s other rights and obligations under this Part 2 of Schedule D, if Genentech is Manufacturing an Active Product on the effective date of termination, it shall continue to comply with its obligations to Manufacture the applicable Active Product under Article 10 herein and the Manufacturing and Supply Agreement(s), unless it provides written notice to Novartis that it does not intend to continue to Manufacture and supply to Novartis such Active Product. In the event that Genentech provides such notice to Novartis, Genentech will supply Novartis with Clinical Requirements and Commercial Requirements of such finished and packaged Active Product(s) at the same price and other terms and conditions as Genentech was supplying, or in the absence of termination, would have been required to supply of such finished and packaged Active Product (under Article 10 hereof), until ***** the date of Novartis’ receipt of such notice, and, if Novartis so requests no more than ***** after the date it received such notice, for *****, provided that the price at which such Active Products will be supplied for such ***** and other terms and conditions on which such Active Products will be supplied for ***** shall be reasonable and customary as determined by good faith negotiations between the Parties, provided further that such ***** is subject to the reasonable cooperation of Genentech. Notwithstanding the foregoing, in no event shall Genentech be obligated to Manufacture a higher volume of Active Product than (i) the reserved manufacturing capacity in the manufacturing facility(ies) of Genentech, its Affiliate(s) or sublicense(s) as set forth in the Manufacturing and Supply Plan, with respect to the ***** of the transition period, and (ii) the average of such manufacturing capacity reserved for the ***** of the transition period, with respect to the ***** of the transition period. Subject to the foregoing, Genentech’s obligations under Section 10.3 of this Agreement, the Manufacturing and Supply Agreement and Sections 5.2(a) and 5.2(c) of the JCA and all other related provisions (if any) under the Ancillary Agreements shall terminate. The applicable Manufacturing and Supply Agreement shall terminate at the end of such ***** period, as applicable.
Appears in 2 contracts
Samples: Tripartite Cooperation Agreement, Tripartite Cooperation Agreement (Tanox Inc)
Manufacture. Without limiting Genentech’s other rights (a) During the Term and obligations under subject to this Part 2 of Schedule D, if Genentech is Manufacturing an Active Product Section 3.4. CDI (and its Affiliates) shall have the exclusive right to manufacture and supply iPSC to Century for [***] beginning on the effective date Effective Date. If at any time following [***] of terminationthe Effective Date, it shall continue Century wishes to comply with its obligations to Manufacture the applicable Active Product under Article 10 herein and the Manufacturing and Supply Agreement(shave a Third Party manufacture human iPSC (including TiPSC), unless it provides written notice Century shall discuss with CDI in good faith the possibility of using such Third Party to Novartis manufacture human iPSC (including TiPSC), provided that it does not intend Century shall have the sole discretion to continue determine whether to Manufacture and supply to Novartis use CDI or such Active ProductThird Party for such manufacture of iPSC (including TiPSC). In the event that Genentech provides such notice Century elects to Novartisuse a Third Party manufacturer, Genentech will supply Novartis CDI hereby agrees to amend the terms of this Agreement without delay to provide Century, its Affiliates and Sublicensees with Clinical Requirements and Commercial Requirements the necessary licenses under the Licensed Patent Rights for the Exploitation of such finished products, including amending the definition of “Licensed Product” to remove the limitation that iPSC be exclusive manufactured by CDI. The Parties shall negotiate in good faith as soon as reasonably practical the terms of a manufacturing and packaged Active Product(ssupply agreement under which CDI or its Affiliate would itself manufacture and supply iPSC (a “Supply Agreement”) at and the same price terms of a quality agreement which would provide the responsibilities of Century and other CDI or its Affiliates for quality assurance of human iPSC (including TiPSC) and the Licensed Products referenced in the Supply Agreement (a “Quality Agreement”).
(b) The Supply Agreement and Quality Agreement shall each contain terms and conditions as Genentech was supplying, or in that are commercially reasonable given the absence terms of termination, would have been required to supply of such finished and packaged Active Product (under Article 10 hereof), until ***** the date of Novartis’ receipt of such notice, and, if Novartis so requests no more than ***** after the date it received such notice, for *****, provided that the price at which such Active Products will be supplied for such ***** and other terms and conditions on which such Active Products will be supplied for ***** shall be reasonable and customary as determined by good faith negotiations between the Parties’ collaboration under this Agreement, provided further including manufacturing capacity, quantity, forecasting, timeliness of delivery, quality, cost, and failure of supply that such ***** is subject to the reasonable cooperation of Genentech. Notwithstanding the foregoing, in no event are consistent with prevailing industry standards for Third Party contract manufacturing agreements for comparable products.
(c) The Supply Agreement shall Genentech be obligated to Manufacture a higher volume of Active Product than provide:
(i) the reserved manufacturing capacity in the manufacturing facility(iesCDI’s (and its Affiliates) of Genentech, exclusive right to manufacture and supply human iPSC (including TiPSC) to Century and its Affiliate(s) or sublicense(s) as set forth in the Manufacturing and Supply Plan, with respect to the ***** of the transition period, and Sublicensees:
(ii) CDI’s (and its Affiliates or contractors) obligations to perform manufacturing activities in a good scientific manner and in compliance in all material respects with all applicable Law; and
(iii) Century’s ability to manufacture by itself or through its Affiliate, or to grant to a Third Party manufacturer the average of such manufacturing capacity reserved for the ***** of the transition period, with respect right to the ***** of the transition period. Subject to the foregoing, Genentech’s obligations under Section 10.3 of this Agreementmanufacture, the Manufacturing and Supply Agreement and Sections 5.2(a) and 5.2(c) Licensed Products in minimal quantities necessary to prevent a supply interruption in the event of the JCA and all other related provisions (if any) under the Ancillary Agreements shall terminate. The applicable Manufacturing and Supply Agreement shall terminate at the end of such ***** period, as applicablea non-supply event upon Century’s request.
Appears in 2 contracts
Samples: License Agreement (Century Therapeutics, Inc.), License Agreement (Century Therapeutics, Inc.)
Manufacture. Without limiting Genentech’s the other rights and obligations of the Terminating Party(ies) under this Part 2 1 of Schedule D, if Genentech each Terminating Party that is Manufacturing an Active Product on the effective date of termination, it termination with respect to such Terminating Party(ies) shall continue to comply with its obligations to Manufacture the applicable Active Product under Article 10 herein and the Manufacturing and Supply Agreement(s), unless it provides written notice to Novartis Tanox that it does not intend to continue to Manufacture and supply to Novartis Tanox such Active Product. In the event that Genentech After such Terminating Party(ies) provides such notice to NovartisTanox, Genentech such Terminating Party(ies) will supply Novartis Tanox with Clinical Requirements and Commercial Requirements of such finished and packaged Active Product(s) at the same price and other terms SCHEDULE D and conditions as Genentech the Terminating Party(ies) was supplying, or in the absence of termination, would have been required to supply of such finished and packaged Active Product (under Article 10 hereof), until ***** of the date of Novartis’ Tanox’s receipt of such notice, and, if Novartis Tanox so requests no more than ***** after the date it received such notice, for *****, provided that the price at which such Active Products will be supplied for such ***** and other terms and conditions on which such Active Products will be supplied for ***** shall be reasonable and customary as determined by good faith negotiations between the Parties, provided further that such ***** is subject to the reasonable cooperation of Genentechthe Manufacturing Party. Notwithstanding the foregoing, in no event shall Genentech a Terminating Party be obligated to Manufacture a higher volume of Active Product than (iA) the reserved manufacturing Manufacturing capacity in the manufacturing Manufacturing facility(ies) of Genentechthe Terminating Party, or its Affiliate(s) or sublicense(s) sublicensee(s), as set forth in the Manufacturing and Supply PlanPlan or other equivalent three year Manufacturing plan, with respect to the ***** of the transition period, and (iiB) the average of such manufacturing Manufacturing capacity reserved for the ***** of the transition period, with respect to the ***** of the transition period. Subject to the foregoing, Genentech’s obligations under the Manufacturing and Supply Agreement, and the Terminating Party’s obligations under Section 10.3 of this Agreement, the Manufacturing and Supply Agreement and Sections 5.2(a) and 5.2(c) of the JCA and all other related provisions (if any) under the Ancillary Agreements shall terminate. The applicable Manufacturing and Supply Agreement shall terminate at the end of such ***** period, as applicable.
Appears in 1 contract
Samples: Tripartite Cooperation Agreement