Manufacturing and Supply. Genentech shall be responsible for manufacturing and supplying Licensed Products for clinical use and commercial sale in the Genentech Field.
Manufacturing and Supply. (a) For a period to be established by the JSC and agreed to by Ambit, such agreement not to be unreasonably withheld, which period is intended to support the orderly completion of the manufacturing technology transfer to Astellas to enable the First Commercial Sale in the Territory, Ambit shall continue to have primary operational responsibility for manufacturing and supply to Astellas of Clinical Trial supplies of the Lead Product (including manufacturing any intermediary or any Licensed Compound or other material contained therein for purpose of such supply), and all other activities in support of preparation of the Chemistry, Manufacturing and Controls sections of any Regulatory Materials or Regulatory Approval necessary to support receipt of Regulatory Approval of the Lead Product in the Joint Development Territory. At and after the end of the foregoing period, Astellas shall have sole responsibility and decision making authority on (i) all manufacturing activities and regulatory activities designed to support preparation of the Chemistry, Manufacturing and Controls sections of any Regulatory Materials or Regulatory Approval, pharmaceutical process development (provided that such process development activities shall be overseen by the JSC), and (ii) manufacturing of Clinical Trial supplies and commercial manufacturing for the Lead Product and each other Product developed or commercialized under this Agreement (including any intermediate of any Licensed Compound or other material contained therein) in the Territory. For clarity, nothing in this Section 3.6.2 or any other term or condition of this Agreement is intended to or shall be construed to limit Astellas’s right and license, as provided in Section 3.1, to make and have made any Product (including any intermediary or any Licensed Compound or other material contained therein) at any time during the Term.
Manufacturing and Supply. (a) Depomed shall supply Product for use in conducting Depomed’s development activities for Product in the Field and in the Territory as set forth in Exhibit D.
Manufacturing and Supply. The Parties shall agree upon responsibility for Manufacture of Compound and Product for Development and Commercialization activities hereunder. The Parties intend to determine whether they will use Lilly's pen technology by [...***...], and to finalize appropriate manufacturing and supply agreements for all aspects of manufacturing by [...***...].
Manufacturing and Supply. 3.3.1 Subject to the terms and conditions of this Section 3.3, EPIZYME shall be responsible for the Manufacture and supply of Licensed Compounds and Licensed Products (including the active pharmaceutical ingredients thereof) for use for Development and Commercialization purposes by EPIZYME in the EPIZYME Territory and (unless EISAI elects to undertake such Manufacture and supply as set forth in Section 3.3.2) by EISAI in the EISAI Territory during the Term.
Manufacturing and Supply. EYETECH is exclusively authorized and responsible for the manufacture and supply of all Development Compound and/or Compound Product as necessary for the conduct of the EYETECH Development Program and for all commercial purposes in the Territory. Further, EYETECH is exclusively authorized and responsible for formulation, packaging and labeling including but not limited to package inserts and leaflets for Compound Products.
Manufacturing and Supply. During the Collaboration Term, Ionis will supply up to [***] solely for Praxis to conduct studies under the Research Plan. Except as set forth in this Section 3.4, and subject to Section 3.6.1, Praxis is responsible for supplying all API and finished drug product for the Parties’ activities under this Agreement.
Manufacturing and Supply. 7.1. bioMérieux shall have sole responsibility for the production of its Instruments, Consumables and Assays for both development and commercial purposes, including as applicable selection of subcontractors and suppliers. Supply prices, forecast, order, supply and billing processes are managed directly between bioMérieux and respective manufacturers.
Manufacturing and Supply. Genentech and/or its sublicensee(s) shall be responsible for, and shall bear all associated costs of, manufacturing all preclinical, clinical and commercial forms of such Lead Products, including the bulk drug substance and finished drug product forms thereof. Genentech shall keep Curis reasonably informed of manufacturing and supply related activity.
Manufacturing and Supply. The provisions of Section 2.10 of the Master Collaboration Agreement and the Manufacturing Agreement shall apply to the Parties’ establishment and operation of manufacturing facilities for [***] Products and [***] Products in the Territory. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
