Manufacturing Lead. Amgen will be solely responsible for the manufacturing of Products either by its Affiliates (other than an entity that is disregarded as an entity separate from Amgen as described in Treasury Regulation section 301.7701-3(a)) or by Third Party contract manufacturers, pursuant to contracts the terms of which are consistent with the principles of Section 15.13 hereof, in accordance with a Supply Agreement for each Product. Amgen shall have the right to determine whether to recall Products and to control all recalls of the Products in the Collaboration Territory, and BeiGene shall provide any reasonable assistance requested by Amgen in connection therewith.
Manufacturing Lead. The Party that actually manufactures (itself or through a designee) a specific Product will be the “Manufacturing Lead” for such manufactured Product. For clarity, one Party may be the Manufacturing Lead for drug substance and the other Party may be the Manufacturing Lead for drug product. Subject to Section 4.6 (Shortage; Allocation), the Manufacturing Lead will use Commercially Reasonable Efforts to supply Product in a manner sufficient to fulfill demand for the Product in the Collaboration Territory. Additionally, if Partner elects to become the Manufacturing Lead for a Product in accordance with Section 4.1 (Allocation of Manufacturing Responsibility) or is otherwise appointed the Manufacturing Lead by the CRC, the Parties will, with respect to Products manufactured by Partner, negotiate in good faith supplements to the definitions of Manufacturing Standard Costs and Manufacturing Actual Costs in order to make such definitions consistent, on a GAAP or IFRS basis (as applicable), with the manner in which Partner accounts for its other products.
Manufacturing Lead. The Parties hereby agree that, notwithstanding the provisions of Section 4.1 (Allocation of Manufacturing Responsibility) of the Agreement to the contrary, Amgen shall not be required to elect whether or not to continue as the Manufacturing Lead for AMG570 and AMG557 until [*].
Manufacturing Lead. Reference to "Manufacturing Lead" shall mean Amgen, unless Amgen elects to exercise its right pursuant to Section 6.7
Manufacturing Lead. Denali shall be the Manufacturing Lead for each Research Program and Collaboration Program until the completion of the transfer of Manufacturing responsibilities to Takeda in accordance with this Section 5.2 and Section 5.6. If (a) Denali exercises the Denali Worldwide Royalty Option for such Collaboration Program or (b) Denali proposes to the JPT and the JPT agrees [***] that Denali should transfer Manufacturing Lead responsibilities to Takeda for such Collaboration Program following Takeda’s exercise of the Option, provided that no such JPT agreement or [***] shall be required where such Manufacturing is performed by one or more Third Party Providers, then in each case the JPT will Confidential 50 *** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request. prepare, for the Parties’ approval, a plan for the Manufacturing Technology Transfer consistent with Section 5.6 (the “Manufacturing Transfer Plan”) to transfer Manufacturing responsibilities for such Collaboration Program to Takeda, after which Takeda shall become the Manufacturing Lead with respect to such Collaboration Program. Without limiting the foregoing, Takeda shall not become the Manufacturing Lead with respect to any Collaboration Program until the completion of the applicable Manufacturing Transfer Plan.
Manufacturing Lead. Aerie will be responsible for the Manufacturing of Products either by itself or through its Affiliates or by Third Party contract manufacturers as provided in the manufacturing and supply agreement to be entered into by the Parties in accordance with Section 3.1.3 (the “Manufacturing & Supply Agreement”). Aerie shall consider in good faith any request by Santen to Manufacture Product and/or the final packaging thereof for Santen’s use hereunder; provided that any such decision shall be mutually agreed by the Parties. Either Party will have the right to propose alternative Manufacturing sites to Manufacture the Products for the Territory and may transfer the Manufacturing thereof from one site to another from time to time upon prior written agreement between the Parties; provided that such Manufacturing sites shall meet or be capable of meeting the criteria (including the ability of such Manufacturing sites to fulfil the Product specifications required for the designated countries in the Territory) to be proposed by Santen and agreed by both Parties at the JMSC prior to such agreement on any such Manufacturing site. Santen shall reasonably cooperate with Aerie in good faith to obtain such approval for such Manufacturing sites upon Aerie’s request.
Manufacturing Lead. Advaxis shall have primary responsibility (either by itself, or by the use of a Third Party contract manufacturer approved in writing by Amgen) for the manufacture and supply of Materials in accordance with the Supply Agreement and the Quality Agreement. Notwithstanding the foregoing, Advaxis shall regularly consult with, and consider in good faith any input provided by, Amgen regarding any material manufacturing or process development plans or decisions.
Manufacturing Lead. The Parties hereby agree that, notwithstanding the provisions of Section 4.1 (Allocation of Manufacturing Responsibility) of the Agreement to the contrary, Partner shall be the initial Manufacturing Lead for AZD8630, and the provisions of Section 4.1 will apply mutatis mutandis.
