Manufacturing of the Product. With respect to clinical and commercial supplies of the Product for the performance of future Project Plans, the Operating Committee will use its best efforts to enter into a supply agreement with the supplier that is best able to meet the Parties’ requirements, taking into consideration such factors as price, timing, quality, capacity, quantity, reliability and reputation. Such supplier may be either a Third Party or one of the Parties.
Manufacturing of the Product. This is anticipated to be performed with Genethon’s existing manufacturing process producing AAV8/MTM1 and will be performed according to the Development Plan and agreed to by the JDC:
Manufacturing of the Product. Alpex shall manufacture and supply sufficient quantities of the Product for the Clinical Trials and commercial sale in the Territory to meet Valera's needs during the Term in accordance with current good manufacturing practices (cGMP). Prior to Launch of the Product, Alpex and Valera shall use their best efforts to enter into a Manufacturing and Supply Agreement on terms agreed in good faith on the basis of the principles set forth in Exhibit B hereto.
Manufacturing of the Product. (a) PMRS shall manufacture and deliver the Bulk Product to CollaGenex at all times in full compliance with CGMP's, by a fully validated process, with the Specifications, and in accordance with CollaGenex Quality Assurance Requirements. PMRS shall maintain and furnish to CollaGenex and at CollaGenex's request, any governmental agency (whether domestic or foreign), all records as are necessary and appropriate to demonstrate compliance with CGMPs. PMRS shall manufacture the Bulk Product in a facility maintaining a current drug establishment registration with FDA as set forth in 21 CFR, Part 207 and which has been inspected and approved by the United Kingdom Medicines Control Agency or other analogous regulatory body. PMRS will require reasonable advance notice of which countries' regulations CollaGenex wishes PMRS to be in compliance with and that meeting compliance requirements will be at CollaGenex's expense.
Manufacturing of the Product. Within sixty (60) days following the Effective Date of this Agreement, the Parties shall meet to discuss manufacturing arrangements related to the Product. The Parties agree that Antares shall be the supplier, or be responsible for the manufacture through a Third Person, of the Device and assembly and packaging of the Product, and the Parties shall enter into a mutually acceptable manufacturing agreement providing for such manufacture and supply of the Device and Product (the "Manufacturing Agreement") within [***] of the Effective Date of this Agreement. The Manufacturing Agreement shall include those terms set forth in Section 10.3 below, and such other terms as the Parties may agree. To the extent Antares utilizes any Third Person to perform some or all of its obligations under the Manufacturing Agreement, such Third Person, and the terms upon which it shall provide [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. services for Antares, shall be subject to approval by Lumara in its sole discretion. From the Effective Date of this Agreement until the execution of the Manufacturing Agreement, Lumara may submit purchase orders to Antares to purchase quantities of the Device, provided, however, that no less than [***] Devices may be ordered on any individual purchase order.
Manufacturing of the Product. The Parties agree to use good faith efforts to maximize the value of their development and commercialization activities under this Agreement through implementing an economical supply chain; provided, that, except as otherwise set forth herein, Lilly will have the exclusive right to manufacture, or have manufactured, Compound and/or Product (other than PEG Reagent, which is supplied by Nektar in accordance with Section 5.1(b)) for pre-clinical trial material, clinical trial material and commercial supply, and all cGMP manufactured Product, including Lilly having the authority, in its sole discretion, to make any and all decisions (or take any and all actions) related thereto. In accordance with the Product Development Plan, Nektar may manufacture Compound and/or Product for pre-clinical trial material and clinical trial material, including material for use to perform the Initial Development Activities, under applicable cGMPs. If Nektar uses a contract manufacturer for any of the activities described under this Section 5.2 (or any other supply arrangement as described in Section 5.1), Lilly will have the right to audit and approve (such approval not to be unreasonably withheld or delayed) such contract manufacturer (and Lilly hereby acknowledges that the existing contract manufacturers providing services to Nektar as of the Effective Date will continue doing so until otherwise determined by Lilly). Upon Lilly’s request, Nektar will disclose or deliver to Lilly, or a contract manufacturer designated by Lilly, [***] (and will [***] to obtain all [***] that is necessary or useful (as such usefulness is reasonably determined by [***]) to enable Lilly or a contract manufacturer to manufacture Compound and/or Product [***]; provided however, that in the event Nektar is required under this Agreement to make a transfer of any [***], such transfer shall be subject to the terms and conditions of [***]. Without limiting the foregoing, each Party will use reasonable efforts, each pursuant to the Cost Sharing Allocation in Section 5.4, to facilitate the transfer of such [***].
Manufacturing of the Product. 12.1 Manufacture of the Product. ARIAD US shall Manufacture or have Manufactured the Labeled Bottles, Unlabeled Bottles and API in accordance with the Specifications, cGMP and Applicable Laws in the country of Manufacture and, to the extent applicable, in the Territory.
Manufacturing of the Product
