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. 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. 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.
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. 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. 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:
Manufacture of the Product. 22 7.1 Development and Commercial Supply by Strakan. 22 ARTICLE 8 FINANCIAL TERMS; PAYMENT TERMS 23 8.1 Upfront Payment. 23 8.2 Milestones. 23 8.3 Royalties. 24 8.4 Payment Method. 24 8.5 Taxes. 24 8.6 Records Retention; Financial Audit. 25 ARTICLE 9 CONFIDENTIALITY 27 9.1 Confidential Information. 27 9.2 Publicity; Filing of this Agreement. 28 9.3 Use of Names. 29 9.4 Confidentiality of this Agreement. 29 9.5 Survival. 29 ARTICLE 10 INTELLECTUAL PROPERTY 29 10.1 Inventions Related to the Product. 29 10.2 Specified Patent Maintenance. 30 10.3 Patents Covering Joint Inventions. 30 10.4 Patents Covering Aptalis Inventions. 31 * Confidential treatment requested.
Manufacture of the Product. DSM represents and warrants that all Product shall be manufactured, tested, stored and released in conformance with (i) the Technical Agreement, (ii) all applicable requirements of the Regulatory Standards including cGMPs, (iii) DSM's standard operating procedures, as attached to this Agreement as EXHIBIT H and (iv) the Process. DSM shall not (i) modify the Process, (ii) modify any method of manufacturing or testing the PAA or the Product, (iii) change or relocate any major equipment (as defined in EXHIBIT I) used in the production of the Product, or (iv) change any vendor providing critical materials (as defined in EXHIBIT J) for the manufacture of the Product or any Subcontractor used in the manufacture of the Product without obtaining the prior written consent of GelTex which consent shall not be unreasonably withheld.
