Manufacturing Responsibilities. Subject to the oversight of the JRC, Surface has the sole responsibility to Manufacture (or have Manufactured) Option Target Antibody Candidates, including CD47 Option Target Antibody Candidates, for use in the Option Target Research Programs in accordance with the Option Target Research Plans.
Manufacturing Responsibilities. The Parties agree and acknowledge that the Company will be responsible for the Manufacturing and procurement of clinical supplies required to Manufacture any Products containing HMPL-004 or other Products to which the Company has the right to Manufacture pursuant to any other agreement between it and Xxxxxxxxx or an Affiliate of Xxxxxxxxx. The Company will be further responsible for securing commercial supplies of any such Products, subject to any license agreement that the Company may have entered into. In furtherance of the above, the Company will select any Third Party manufacturers or service providers on best possible commercial terms for the Manufacture. With respect to HMPL-004, Xxxxxxxxx will assign, or procure the assignment, to the Company of all Third Party agreements in effect as of the Effective Date to which Xxxxxxxxx and/or its Affiliates are a party, that relate to procurement of clinical supplies or Manufacturing of HMPL-004 or a Product containing HMPL-004 as required by the Company. The Company will, with the Board’s oversight and input, direct the Manufacturing process of such clinical supplies. With respect to commercial supplies of Products containing HMPL-004 and Products to which the Company has the right to Manufacture hereunder or pursuant to any other agreement between it and Xxxxxxxxx or an Affiliate of Xxxxxxxxx, the Company will be responsible for securing such supply and Xxxxxxxxx will assign, or procure the assignment of, all appropriate agreements to which Xxxxxxxxx and/or its Affiliates is a party related to the Manufacture of such Products, to the Company to the extent and on the timeframe notified to Xxxxxxxxx by the Board. For any Manufacturing activities related to the clinical or commercial supply of relevant Products conducted in whole or in part by Xxxxxxxxx and/or its Affiliates, Xxxxxxxxx will assign, or procure the assignment of, such manufacturing agreements to the Company.
Manufacturing Responsibilities. 8.1.1.1. Subject to the oversight of the JRC, Surface has the sole responsibility to Manufacture (or have Manufactured) T1 Antibody Candidates for use in the T1 Research Program in accordance with the T1 Research Plan. Surface will Manufacture (or have Manufactured) such T1 Antibody Candidates in accordance with Novartis quality standards.
8.1.1.2. Subject to the oversight of the JDC, Surface has the sole responsibility to Manufacture (or have Manufactured) T1 Antibody Candidates and T1 Licensed Products for use in the first Phase 1 Safety Study for the T1 Antibody Candidates and T1 Licensed Products in accordance with the T1 Development Plan. Surface will Manufacture (or have Manufactured) such T1 Antibody Candidates in accordance with Novartis quality standards.
8.1.1.3. Other than the first Phase 1 Safety Study for the T1 Antibody Candidates and T1 Licensed Products, Novartis has the sole responsibility to Manufacture (or have Manufactured) T1 Antibody Candidates and T1 Licensed Products for use in Development and Commercialization of such T1 Antibody Candidates and T1 Licensed Products in the Novartis Territory. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
Manufacturing Responsibilities. Unless otherwise determined by the JSC, Genevant shall be solely responsible for all preclinical, clinical and commercial Manufacture and supply of all Co-Development Products for all uses under this Agreement. BioNTech will supply to Genevant all Co-Development mRNA Payloads for such Manufacture. The Manufacturing Expenses for Co-Development mRNA Payloads Manufactured for preclinical or clinical use will be included in Development Costs and the Manufacturing Expenses for Co-Development mRNA Payloads Manufactured for commercial use will be included in Allowable Expenses. Genevant may conduct such Manufacturing activities itself or through a Third Party CMO under Genevant’s control, subject to Section 4.9 (Subcontractor). Within a reasonable time after the Effective Date, the Parties will execute one or more supply agreements to govern (i) the Manufacturing and supply of Co-Development Products by Genevant or the Third Party CMO selected and controlled by Genevant (“Co-Development Product Supply Agreement”) and (ii) the Manufacturing and supply of Co-Development mRNA Payloads by BioNTech.
Manufacturing Responsibilities. Subject to Section 7.4 (Biogen Manufacturing Assumption Rights), [**] will be the Manufacturing Lead Party (a) for the [**] and (b) [**], unless and until Biogen assumes responsibility as the Manufacturing Lead Party for the [**] pursuant to Section 7.4 (Biogen Manufacturing Assumption Rights) and, in each case ((a) and (b)), [**] will be solely responsible for, and will, Manufacture (or have Manufactured) Licensed Products in accordance with the applicable Manufacturing Plan, the Supply Agreement to be entered into by the Parties pursuant to Section 7.5 (Supply Agreement). The Manufacturing Lead Party will have decision making authority over all day-to-day operational matters related to Manufacturing for Licensed Products for the Territory, subject to (i) the terms of the applicable Supply Agreement, (ii) with respect to [**], the Manufacturing Plan approved by the JSC, and (iii) in any applicable jurisdiction, the NDA- or marketing authorization-holding Party for a Licensed Product will have final decision-making authority sufficient to [**].
Manufacturing Responsibilities. Each Product supplied by Genpharm hereunder shall be manufactured (which shall include, without limitation, all testing, bulk packaging and labelling) in an FDA approved facility and in accordance with the following (collectively, the "Product Manufacturing Requirements"), (i) the Specifications for the Product, (ii) applicable cGMP and good laboratory practices and (iii) all other applicable rules, regulations and requirements of the FDA relative to the manufacture of such Product.
Manufacturing Responsibilities. (a) During the Phase 1
Manufacturing Responsibilities. Roivant shall be solely responsible for all preclinical, clinical and commercial manufacture and supply of Proprietary Drugs and Licensed Products for all uses under this Agreement, at its sole expense. Roivant may conduct such manufacturing activities itself or through a Third Party CMO, subject to Section 4.7 (Subcontractor).
Manufacturing Responsibilities. From the Effective Date, subject to Sections 6.5.1 and 6.5.2 below, GSK (itself or through an Affiliate) shall have the exclusive right to Manufacture Compound and Product for distribution in the Territory, including, without limitation, all batches of drug substance and drug product (including any such batches of drug substance or drug product planned for use to support registration and validation of Product), and will have the right, in accordance with the terms of this Agreement, to appoint one or more Third Parties to Manufacture Compound and Product for such purposes. For the avoidance of doubt, GSK shall have the ultimate decision making authority over the use of Third Parties in its manufacturing supply chain. ****** - Material has been omitted and filed separately with the Commission.
Manufacturing Responsibilities. Except as otherwise provided for in a Research Plan, Axovant shall be solely responsible for all preclinical, clinical, and commercial manufacture and supply of Compounds and Licensed Products for all uses under this Agreement, at its sole expense. Axovant may conduct such manufacturing activities itself or through a CMO, subject to Sections 2.2 (Sublicense Rights) and 4.5 (Axovant Subcontractors). 30
