Common use of Manufacture Clause in Contracts

Manufacture. (a) During the Term and subject to this 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. If at any time following [***] of the Effective Date, Century wishes to have a Third Party manufacture human iPSC (including TiPSC), Century shall discuss with CDI in good faith the possibility of using such Third Party to manufacture human iPSC (including TiPSC), provided that Century shall have the sole discretion to determine whether to use CDI or such Third Party for such manufacture of iPSC (including TiPSC). In the event that Century elects to use a Third Party manufacturer, CDI hereby agrees to amend the terms of this Agreement without delay to provide Century, its Affiliates and Sublicensees with the necessary licenses under the Licensed Patent Rights for the Exploitation of such 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 supply agreement under which CDI or its Affiliate would itself manufacture and supply iPSC (a “Supply Agreement”) and the terms of a quality agreement which would provide the responsibilities of Century and 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 that are commercially reasonable given the terms of the Parties’ collaboration under this Agreement, including manufacturing capacity, quantity, forecasting, timeliness of delivery, quality, cost, and failure of supply that are consistent with prevailing industry standards for Third Party contract manufacturing agreements for comparable products. (c) The Supply Agreement shall provide: (i) CDI’s (and its Affiliates) exclusive right to manufacture and supply human iPSC (including TiPSC) to Century and its 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 right to manufacture, the Licensed Products in minimal quantities necessary to prevent a supply interruption in the event of a non-supply event upon Century’s request.

Manufacture. (a) During Without limiting Genentech’s other rights and obligations under this Part 2 of Schedule D, if Genentech is Manufacturing an Active Product on the Term effective date of termination, it shall continue to comply with its obligations to Manufacture the applicable Active Product under Article 10 herein and subject the Manufacturing and Supply Agreement(s), unless it provides written notice to this Section 3.4. CDI (and its Affiliates) shall have the exclusive right Novartis that it does not intend to manufacture continue to Manufacture and supply iPSC to Century for [***] beginning on the Effective Date. If at any time following [***] of the Effective Date, Century wishes to have a Third Party manufacture human iPSC (including TiPSC), Century shall discuss with CDI in good faith the possibility of using Novartis such Third Party to manufacture human iPSC (including TiPSC), provided that Century shall have the sole discretion to determine whether to use CDI or such Third Party for such manufacture of iPSC (including TiPSC)Active Product. In the event that Century elects Genentech provides such notice to use 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 Third Party manufacturerhigher volume of Active Product than (i) the reserved manufacturing capacity in the manufacturing facility(ies) of Genentech, CDI hereby agrees its Affiliate(s) or sublicense(s) as set forth in the Manufacturing and Supply Plan, with respect to amend the terms ***** 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 without delay to provide CenturyAgreement, its Affiliates the Manufacturing and Sublicensees with the necessary licenses under the Licensed Patent Rights for the Exploitation of such 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 supply agreement under which CDI or its Affiliate would itself manufacture and supply iPSC (a “Supply Agreement”) and the terms of a quality agreement which would provide the responsibilities of Century and 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 Sections 5.2(a) and conditions that are commercially reasonable given the terms 5.2(c) of the Parties’ collaboration JCA and all other related provisions (if any) under this Agreement, including manufacturing capacity, quantity, forecasting, timeliness of delivery, quality, cost, the Ancillary Agreements shall terminate. The applicable Manufacturing and failure of supply that are consistent with prevailing industry standards for Third Party contract manufacturing agreements for comparable products. (c) The Supply Agreement shall provide: (i) CDI’s (and its Affiliates) exclusive right to manufacture and supply human iPSC (including TiPSC) to Century and its 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 Affiliateterminate at the end of such ***** period, or to grant to a Third Party manufacturer the right to manufacture, the Licensed Products in minimal quantities necessary to prevent a supply interruption in the event of a non-supply event upon Century’s requestas applicable.

Manufacture. (aWithout limiting the other rights and obligations of the Terminating Party(ies) During under this Part 1 of Schedule D, each Terminating Party that is Manufacturing an Active Product on the Term and subject effective date of termination with respect to this Section 3.4. CDI (and its Affiliatessuch Terminating Party(ies) shall have continue to comply with its obligations to Manufacture the exclusive right applicable Active Product under Article 10 herein and the Manufacturing and Supply Agreement(s), unless it provides written notice to manufacture Tanox that it does not intend to continue to Manufacture and supply iPSC to Century for [Tanox such Active Product. After such Terminating Party(ies) provides such notice to Tanox, such Terminating Party(ies) will supply 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 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 ***] beginning on ** of the Effective Date. If at any time following [date of Tanox’s receipt of such notice, and, if Tanox so requests no more than ***] of ** after the Effective Datedate it received such notice, Century wishes to have a Third Party manufacture human iPSC (including TiPSC), Century shall discuss with CDI in good faith the possibility of using such Third Party to manufacture human iPSC (including TiPSC)for *****, provided that Century shall have the sole discretion to determine whether to use CDI or price at which such Third Party Active Products will be supplied for such manufacture ***** 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 iPSC the Manufacturing Party. Notwithstanding the foregoing, in no event shall a Terminating Party be obligated to Manufacture a higher volume of Active Product than (including TiPSCA) the reserved Manufacturing capacity in the Manufacturing facility(ies) of the Terminating Party, or its Affiliate(s) or sublicensee(s), as set forth in the Manufacturing and Supply Plan or other equivalent three year Manufacturing plan, with respect to the ***** of the transition period, and (B) the average of such Manufacturing capacity reserved for the ***** of the transition period, with respect to the ***** of the transition period. In Subject to the event that Century elects to use a Third Party manufacturerforegoing, CDI hereby agrees to amend Genentech’s obligations under the terms Manufacturing and Supply Agreement, and the Terminating Party’s obligations under Section 10.3 of this Agreement without delay to provide Century, its Affiliates and Sublicensees with Sections 5.2(a) and 5.2(c) of the necessary licenses JCA and all other related provisions (if any) under the Licensed Patent Rights for the Exploitation of such products, including amending the definition of “Licensed Product” to remove the limitation that iPSC be exclusive manufactured by CDIAncillary Agreements shall terminate. The Parties shall negotiate in good faith as soon as reasonably practical the terms of a manufacturing applicable Manufacturing and supply agreement under which CDI or its Affiliate would itself manufacture and supply iPSC (a “Supply Agreement”) and the terms of a quality agreement which would provide the responsibilities of Century and 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 that are commercially reasonable given the terms of the Parties’ collaboration under this Agreement, including manufacturing capacity, quantity, forecasting, timeliness of delivery, quality, cost, and failure of supply that are consistent with prevailing industry standards for Third Party contract manufacturing agreements for comparable products. (c) The Supply Agreement shall provide: (i) CDI’s (and its Affiliates) exclusive right to manufacture and supply human iPSC (including TiPSC) to Century and its 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 Affiliateterminate at the end of such ***** period, or to grant to a Third Party manufacturer the right to manufacture, the Licensed Products in minimal quantities necessary to prevent a supply interruption in the event of a non-supply event upon Century’s requestas applicable.