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.
Manufacture of the Product. Subject to and as further described in Sections 2.5.b. and 2.5.c., SIIPL will have [***], and shall use its [***], with respect to obtaining and maintaining the facilities and all necessary raw materials, equipment, qualified personnel, Regulatory Approvals, licenses, and permits to Develop and Manufacture the Product as necessary to perform its obligations under this Agreement within the SIIPL Territory. SIIPL will solely be responsible for all vendors, employees, contractors, and other Persons employed or engaged by it, and all costs and expenses incurred, in the performance of such obligations. Notwithstanding the previous, SIIPL agrees to provide rights of access to regulatory files related to countries that at any time during the Term belonged in the SIIPL Non-Exclusive Territory and agrees to work in collaboration with Novavax or its designee. SIIPL and Novavax, including any of their licensees agree that in no case will it use a permit, a regulatory licenses or a contractual arrangement as a means of preventing the other Party or any of its licensees from Developing, Manufacturing and/or Commercializing the Product in the SIIPL Non- Exclusive Territory.
Manufacture of the Product. 4.1.1 During the Supply Phase, FRESENIUS shall manufacture and supply to TRANSMEDICS the quantities of Products ordered by TRANSMEDICS from time to time pursuant to Section 5.3.
4.1.2 The Products manufactured shall conform to cGMP, the Quality Agreement, all applicable laws, and the Product Specifications (as may apply from time to time, collectively, the “Production Standards”).
Manufacture of the Product. ASLAN shall manufacture the Product directly or through any Third Party subject to the provisions of Section 15.1 below. ASLAN recognises and agrees that such manufacture will be performed under ASLAN’s exclusive control and without ALMIRALL’s involvement. ALMIRALL shall neither be obliged to provide ASLAN with any information nor with any amount of the Compound, product, material, raw material, excipients, etc., necessary for manufacturing the Product, nor with any personal or material assistance. ASLAN shall only be entitled to entrust the manufacturing of the Product to a Third Party, provided that such Third Party agrees in advance to comply with the obligations included in Section 9.8.
Manufacture of the Product. Alkermes shall Manufacture the Product for supply to Cephalon. Alkermes shall Manufacture, or have Manufactured by a designated Third Party, the Diluent, the Additional Components, and the Finished Product (packaging and labeling of the Product) for supply to Cephalon.
Manufacture of the Product. The Product shall be Manufactured in accordance with cGMP, the Manufacturing License, Applicable Laws and the Quality Agreement;
Manufacture of the Product. Subject to the terms and conditions of this Agreement, Pacira shall perform, or procure from a Third Party Manufacturer the performance of, the Manufacturing Services in accordance with:
2.2.1 the Specifications; PACIRA & EKR CONFIDENTIAL
2.2.2 all cGMPs and other regulations now in place or established during the Term by a Relevant Authority that are applicable to the performance of the Manufacturing Services;
2.2.3 all Applicable Laws relating to the performance of Manufacturing Services; and
2.2.4 the Packaging and Labelling Specifications.
Manufacture of the Product. VIVUS shall be responsible for manufacturing the PRODUCT using the BULK DRUG SUBSTANCE and BULK DRUG TABLETS supplied by TANABE pursuant to Article 7. It is understood and agreed that VIVUS’ manufacture of the PRODUCT using BULK DRUG TABLETS shall be limited to packaging and labeling of such PRODUCTS.
Manufacture of the Product. Nastech shall manufacture and supply the Product to LICENSEE in amounts to be sufficient to meet LICENSEE's requirements for the sale thereof (including the requirements of its Affiliates and sublicensees) as determined in accordance with Section 8.
Manufacture of the Product. Raw Materials and API. Encap shall manufacture and supply Product in accordance with the Specifications. Encap shall execute process validation batches and perform validation services with protocols, time lines and pricing as agreed to between the Parties in writing. PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION FOR CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT; [***] DENOTES OMISSIONS. Promptly following execution of this Agreement, Encap shall commence such activities as necessary to ensure that it has sufficient capacity to meet its Product supply obligations hereunder which activities shall include recruitment of personnel and construction of additional clean rooms as are necessary to ensure Encap’s ability to meet its supply obligations set forth in this Agreement. Encap shall be responsible for procuring raw materials from vendors qualified by Customer, inspecting and releasing adequate raw materials in accordance with the Specifications as necessary to meet the Firm Order, unless otherwise agreed to by the Parties in writing. Encap shall keep safety stock of raw materials required for the manufacture of the Product of at least the [***] or such time as Encap is in a position to manufacture [***] of Product per month, when at such time the required amount of safety stock shall be re-evaluated in good faith by each of the Parties.
