Manufacturing and Supply Sample Clauses
Manufacturing and Supply. Genentech and/or its Affiliates or sublicensee(s) shall be responsible for, and shall bear all associated costs of, manufacturing all preclinical, clinical and commercial forms of such Genentech Products, including the bulk drug substance and finished drug product forms thereof.
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. 7.1 SUPPLY OF THE DRUG.
Manufacturing and Supply. GW shall be solely responsible, at its own cost for the manufacture and supply of Novartis’ requirements of finished Product, or BDP for use in the packaging and labeling of finished Product, for Commercialization in the Field in the Territory, as set forth in the Manufacturing and Supply Agreement. For clarity, as provided for in Exhibit F, the supply of finished Product is an additional service which may be provided if (i) requested by Novartis, and (ii) the Parties agree upon the fees for this service.
Manufacturing and Supply. Subject to the terms and conditions of this Agreement, Licensee shall have the exclusive right to manufacture the Licensed Compounds and the Licensed Products itself or through one or more Third Party subcontractor(s) selected by Licensee.
Manufacturing and Supply. 8.1 Regeneron Supply of Product.8.1.1 Exclusive Right for Regeneron to Supply Product. Until the occurrence of a Manufacturing Technology Transfer Event, Regeneron shall have the exclusive right to Manufacture or have Manufactured and supply or have supplied the Product for all Development and Commercialization purposes in the Kiniksa Field in the Territory. As of the Effective Date, Regeneron or one of its Affiliates (a) Manufactures the Formulated Bulk Product in its own facilities, and (b) uses a Third Party Fill/Finish Provider to perform the finishing, filling, assembly, packaging, and testing of all Filled Product.8.1.2 Reestablishing Protocols. The Parties acknowledge and agree that Regeneron will need to reestablish protocols for the Manufacture of the 80mg dosage form for the Existing Product Formulation if such dosage form is requested by Kiniksa under the Supply Agreements. Regeneron’s Fully-Burdened Cost for the performance of activities related to re-establishing the protocols for the Manufacture of the 80mg dosage form of the Existing Product Formulation shall be considered Other Shared Expenses.8.1.3 Notification of Transfer of Manufacturing Activities. If at any time during the Term, Regeneron desires to transfer a portion or all of the Manufacturing activities for the Product to any of its Affiliates or one or more Third Parties, then Regeneron will first provide written notice thereof to Kiniksa in accordance with the Quality Agreement; provided that, consistent with Section 8.14.1 (Manufacturing Technology Transfer Event), Regeneron may not provide notice that it (or its Affiliates) wishes to discontinue the Manufacture of any Formulated Bulk Product under the Supply Agreement prior to the earlier of (a) [***] years after the date of receipt of U.S. Marketing Approval, or (b) [***] after the Effective Date, if U.S. Marketing Approval has not been obtained. If at any time during the Term, Regeneron desires to transfer a portion or all of such Manufacturing activities to one or more Third Parties, then Regeneron shall consider in good faith any Third Party contract manufacturers proposed by Kiniksa. After U.S. Marketing Approval, at Kiniksa’s request, the Parties shall discuss whether Kiniksa (instead of Regeneron) should directly enter into a supply agreement with the agreed Third Party contract manufacturer if Regeneron delivers notice that Regeneron desires to transfer a portion or all of such Manufacturing activities to one or more Thi...
Manufacturing and Supply. Arbutus will (a) be responsible for the Manufacture of Products for [***], (b) provide associated manufacturing and analytical documentation, (c) be responsible for [***] in not later than [***] (provided that Gritstone will be responsible for the [***]), and (d) transfer, not later than [***], the [***], which will be determined by Gritstone. After successful transfer of the LNP formulation to Gritstone and/or Gritstone’s CMO, Gritstone will assume responsibilities for future manufacturing of Products; provided that Arbutus will provide ongoing technical support if requested by Gritstone.
Manufacturing and Supply. Denali shall be responsible for manufacturing Licensed Products for clinical use and commercial sale, using due care and commercially sound approaches.
Manufacturing and Supply. During the term of this Agreement and subject to the terms and conditions hereof, Toray shall Manufacture and supply Products to Acologix and its Sublicensees for North America in accordance with the terms and conditions of this Article 6 for the purposes of Development and Commercialization of Products in Europe and North America, and Acologix agrees to source all of its requirements for Products from Toray, except as otherwise provided in Section 6.7 below.
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.