Manufacturing Generally. All Clinical Supplies and Commercial Supplies will be Manufactured in accordance with GLP and GMP, as applicable, and Applicable Law. In addition, the Manufacturing process used for Clinical Supplies and Commercial Supplies shall be in accordance with the IND, NDA, or other Regulatory Approval, as applicable, for the Licensed Product or Licensed Compound.
Manufacturing Generally. Subject to Section 7.2 and Section 7.3, Licensee shall have sole control, at its sole expense, over manufacturing, and controlling the supply chain for, all Licensed Products for use and/or sale by Licensee, its Affiliates, and its permitted Sublicensees in the Territory. To the extent Company is responsible for Manufacturing clinical and commercial supply, without limiting the foregoing:
Manufacturing Generally. All Licensed Adjuvants supplied to Genocea for inclusion in Clinical Supplies and Commercial Supplies will be Manufactured in accordance with GLP and GMP, as applicable, and Applicable Law. In addition, the manufacturing process used for such Licensed Adjuvants shall be in accordance with the IND, NDA or other Regulatory Approval, as applicable, for the Licensed Product.
Manufacturing Generally. Novartis or its designated sublicensee(s) will be solely responsible for the manufacture and supply of its Products being Developed or Commercialized under this Agreement.
Manufacturing Generally. (a) Subject to the terms and conditions of this Agreement, Sanofi-Aventis shall at all time Control the Manufacturing process development and may elect to Manufacture a Lead Compound, Development Candidate or a Product at any time during the Term. Any and all technology and Information relating to and required for the Manufacturing of a Lead Compound, a Development Candidate or a Product (including, as the case may be, any related Third Party agreements) (the “Manufacturing Technology”) [ * ] during the Term of this Agreement, shall be transferred and assigned to Sanofi-Aventis and disclosed pursuant to Section 7.3, within a reasonable period following Exelixis’ receipt of notification in writing by Sanofi-Aventis of its election to take over the Manufacturing of such Lead Compound, Development Candidate or Product.
(b) Notwithstanding the foregoing, the Party designated by the JRDC pursuant to Section 7.2(a) to perform process development and Manufacturing activities shall, retain responsibility for the Manufacture and supply of part or all of the Clinical Supply Requirements necessary for the Development of a Development Candidate or a Product in accordance with Section 7.2(c).
Manufacturing Generally. Subject to Section 2.4(b), Celgene will be solely responsible for, and will bear all the costs and expenses of, Manufacturing and supplying all Elected Candidate and Licensed Product for Development and Commercialization in the Field worldwide. Subject to Section 2.4(b), Celgene will purchase Vector Supply from Bluebird or its authorized designee for such purposes. Notwithstanding anything herein to the contrary, subject to, and with effect from, the expiry or termination of the Manufacturing and Supply Agreement, Celgene will assume sole responsibility for the Manufacture and supply of Vector including associated Payloads for the Development and Commercialization of Elected Candidate and Licensed Product for U.S. Administration and ROW Administration in accordance with this License Agreement.
Manufacturing Generally. For avoidance, of doubt, BP shall have sole control over all aspects of the Manufacture of the Products in every country of the world. Pieris Manufacturing Assistance. Without limiting BP’s rights or Pieris’ obligations described in Section 4.3, Section 4.4 or Section 4.5, and as reasonably requested or directed by BP, Pieris shall provide up to [***] Dollars ($[***]) in FTE Costs and Out-of-Pocket Costs connection with the Manufacture of Products. The anticipated contribution of Pieris shall be included in the Product Development Plan, subject to Pieris’ consent with
Manufacturing Generally. Subject to Sections 6.2, 6.3, and 6.5, Sanofi shall be responsible, during the term of this Agreement, for the Manufacture, under its sole authority, of all of its requirements of Product and Product’s active pharmaceutical ingredient (“API”), for use by Sanofi, its Affiliates and their sublicensees in the Sanofi Territory. On March 25, 2013, Vivus and Sanofi Chimie, an Affiliate of Sanofi executed a Technology Transfer and Development Services Agreement (the “Technology Transfer and Development Services Agreement”) for the transfer to Sanofi Chimie of the manufacturing process for the API described in the Product’s active substance master file existing as of the Effective Date.
Manufacturing Generally. (a) Subject to Sections 7.1(b) and 7.2 and in accordance with Section 7.4, it is the Parties’ intention to transfer responsibility for the Manufacture of the Licensed Compounds and the Products to Sanofi-Aventis within the shortest delay possible following the Effective Date and Exelixis agrees to cooperate with Sanofi-Aventis toward that goal.
(b) Notwithstanding the foregoing, Exelixis agrees that it shall retain responsibility for the Manufacture and supply of all of the Clinical Supply Requirements necessary for the Development of the Products in accordance with Section 7.2, until and pending the actual transfer of the Manufacturing responsibility to Sanofi-Aventis in accordance with Section 7.4.
Manufacturing Generally. Notwithstanding the terms and conditions of the Praluent Supply Agreements, it is the Parties’ intention to transfer responsibility for the Manufacture of all forms of Praluent Products (and of the constituents thereof) to (a) Sanofi for all clinical and commercial requirements of Praluent Products with respect to Development and Commercialization activities of Sanofi, its Affiliates and its and their Sublicensees and (b) Regeneron for all clinical and commercial requirements of Praluent Products with respect to Development and Commercialization by Regeneron, its Affiliates and its and their Sublicensees, in each case ((a) and (b)) pursuant to the terms and conditions of this Agreement. The Parties shall cooperate diligently toward that goal in accordance with the terms and conditions of [* * *] the Drug Substance Tech Transfer Plan referred to in Section 7.3.
