Manufacture of Products. All Products marketed through Grantor's Web ------------------------- Site shall be manufactured, packaged, prepared, and shipped in accordance with the specifications and requirements described on Exhibit A hereto as it may be modified from time to time. Quality control standards relating to the Product's weight, color, consistency, micro-biological content, labeling and packaging are also set forth on Exhibit A. In the event that Exhibit A is incomplete, Products shall be manufactured and shipped in accordance with industry standards.
Manufacture of Products. Manufacturer shall use commercially reasonable efforts to maintain the necessary manufacturing capability to fill all orders for Products received from Distributor and accepted pursuant to the provisions of this Agreement. In the event of a Product shortage for any reason, Manufacturer shall have the right to allocate or apportion available Products among its customers as Manufacturer, in the exercise of its discretion, and upon prior consultation with Distributor, deems appropriate, without incurring any liability to Distributor. Manufacturer may discontinue the manufacture or sale of any Products upon twelve (12) months’ prior written notice to Distributor. Manufacturer may materially alter the performance of any or all of the Products upon ninety (90) days prior notice to Distributor. Notwithstanding the foregoing, Manufacturer may discontinue the manufacture and sale of any Product at anytime and without notice to Distributor, if such discontinuance is required, directly or indirectly, by any regulatory agency.
Manufacture of Products. 12.1. GW shall at its own cost obtain and throughout the term of this Agreement maintain all necessary Manufacturing Licences or procure that Manufacturing Licences are maintained by the Authorised Contractors and perform its, or procure the performance by the Authorised Contractors of their, obligations hereunder in accordance with the Manufacturing Licences and all applicable laws and legislation in the Territory. GW shall supply a copy of each such Manufacturing Licence to Bayer or its Affiliates free of charge on written request.
12.2. All personnel employed by GW or the Authorised Contractors in the Manufacture of the Products shall be suitably trained, experienced and competent for their respective functions with particular reference to performing their assigned duties in accordance with Good Manufacturing Practice. GW shall, or shall procure that the Authorised Contractors shall, keep written records of the training provided to such employees, copies of which shall be made available to Bayer on request.
12.3. GW covenants with Bayer not at any time during the term of this Agreement to carry out any other activities that may, to GW’s knowledge at the time of the said activity, prejudice the quality, safety or efficacy of the Products.
Manufacture of Products. (a) In accordance with the terms of this Agreement, BIRI shall perform the MANUFACTURING SERVICES with respect to each PRODUCT, XANODYNE shall order and purchase each of the PRODUCTS in finished dosage form from BIRI, and BIRI shall sell and deliver such purchased PRODUCTS to XANODYNE. Subject to the terms and conditions contained herein, BIRI shall perform the MANUFACTURING SERVICES in accordance with: (i) the SPECIFICATIONS for each of the PRODUCTS; (ii) all regulations now in place or hereafter established by the FDA (including, but not limited to, GOOD MANUFACTURING PRACTICES, and 21 C.F.R. Part 11), DEA or any other GOVERNMENTAL AGENCY that are applicable to the performance of MANUFACTURING SERVICES with respect to the applicable PRODUCT; and (iii) all material requirements of other federal, state or local laws and regulations applicable to the performance of MANUFACTURING SERVICES with respect to the applicable PRODUCT.
(b) BIRI shall be responsible for (i) obtaining all materials, ingredients and components required to manufacture each of the PRODUCTS in accordance with the SPECIFICATIONS; and (ii) supplying all other equipment, materials and personnel necessary for the performance of the MANUFACTURING SERVICES and delivery of the PRODUCTS in finished package form to XANODYNE. BIRI shall maintain in its inventory such quantity of materials, ingredients and components necessary for BIRI to perform its obligations hereunder in reliance on Xanodyne's most recently submitted forecast pursuant to Section 5.5.
(c) BIRI shall perform the MANUFACTURING SERVICES at its PLANT in Columbus, Ohio.
(d) BIRI shall ensure that, at the time of delivery of the PRODUCTS to a common carrier for shipment to XANODYNE: (a) the PRODUCTS shall conform to the SPECIFICATIONS; (b) the PRODUCTS shall, subject to XANODYNE's timely provision of compliant and accurate LABELING and artwork, not be adulterated or misbranded under applicable laws; and (c) the PRODUCTS shall have a remaining shelf life of not less than [**] months on products with a [**] month expiry and [**] months on products with a [**] month expiry unless mutually agreed upon by both parties in advance of shipment.
Manufacture of Products. Ironwood will be responsible for Manufacture of Development Materials and for API Manufacturing; provided, however, that nothing in this Agreement will prevent Ironwood from contracting with any Third Parties to Manufacture Development Materials or to conduct API Manufacturing, provided that such Third Parties shall comply with all requirements pursuant to this Agreement and the Manufacturing and Supply Agreement and that Ironwood shall be fully responsible for such Third Party’s compliance with such requirements. Ironwood will perform all such Manufacturing activities in accordance with GCP, GLP and GMP. Ironwood will supply Development Material and Licensed Compound for Commercial supply to Astellas in bulk form ready for formulation, packaging and labeling. Ironwood will be responsible for shipping the bulk Development Material and other Licensed Compound to the locations designated by Astellas. Development Material and Licensed Compound for Commercial supply will be shipped to Astellas F.O.B. [**], and title to such Development Material and other Licensed Compound will pass to Astellas upon placement by Ironwood with a carrier for delivery to Astellas. Astellas will be responsible, at its sole cost and expense, to complete the drug product manufacturing, packaging, and labeling of the Licensed Compound. In furtherance of the foregoing, the Parties will execute a manufacturing and supply agreement promptly following the Effective Date, (a) under which Astellas will pay Ironwood [**] for supplying Development Material and Commercial supply of the Licensed Compound for the Product to Astellas, [**], and (b) which will contain, at a minimum, such terms and conditions as are described in Schedule 3.4 hereto and the last sentence of Section 4.10 (“Manufacturing and Supply Agreement”). Notwithstanding anything else contained herein, Astellas may not exercise its right to Manufacture Development Materials or Licensed Compound pursuant to the grant of rights under Section 2.1 unless (i) Ironwood has failed to supply Development Materials or Licensed Compound for Commercialization to Astellas under circumstances which, under the Manufacturing and Supply Agreement, would permit Astellas to Manufacture Development Materials or [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. Licensed Compound for Commercialization, (“Failure To Supply...
Manufacture of Products. Subject to the terms and conditions of this Agreement, including without limitation Section 4.1, Arch shall have the exclusive right to manufacture Products using the Codexis Process and Codexis Enzymes. Arch may not use any enzymes other than Codexis Enzymes or any processes other than Codexis Processes in any step of the manufacture of the Products unless a non-enzymatic process is the only process available for the relevant manufacturing step. For the avoidance of doubt and notwithstanding anything in this Agreement to the contrary, (i) subject to Section 4.1, neither Arch nor its Affiliates may purchase any intermediates that fall within the definition of Products from any Third Party and (ii) Arch may purchase the intermediate [*] from Third Parties.
Manufacture of Products. HDU agrees to manufacture, package, and store the Products under the conditions and in accordance with the principles and practices according to the standards of the trade, and consistent with all applicable laws and regulations including without limitation, regulations of the United States Department of Agriculture (“USDA”). HDU shall ensure that the quality, materials and generally the characteristics of the Product (including, without limitation, taste, texture, color and overall appearance) are substantially similar to the Products previously supplied by HDU to, and approved by, MamaMancini’s. HDU shall maintain a quality assurance team which shall oversee production of the Product. Not less frequently than annually, HDU shall engage NSF-Cxxx & Txxxxxx, or another independent third party expert acceptable to both HDU and MamaMancini’s, to conduct a process-based food safety and quality audit to determine whether HDU has appropriately designed systems that are being operated under continual control to assure product safety, quality, and consistency; and shall take any corrective actions required by such audit. HDU agrees to manufacture and package the Product itself, solely through its own employees, and shall not be permitted to delegate or sub license all or any part of such manufacture or packaging without the prior written consent of MamaMancini’s.
Manufacture of Products a. Manufacture. Manufacturer will manufacture the Products using the components and to the specifications provided on Appendix B as updated from time to time in accordance with Section 15 hereof (the "Specifications"). Manufacturer will only use components from vendors approved by Purchaser for the supply of such components. Following the Effective Date, Manufacturer may, with Purchaser's prior written approval, identify and qualify other vendors for the purpose of reducing costs or improving quality.
b. Quality. All Products manufactured by Manufacturer for Purchaser shall conform to Manufacturer's quality procedures and workmanship standards consistent with IPC-610 class II. Manufacturer will perform on-going reliability testing in order to ensure Product reliability over time. Testing specifications and the acceptance test plan will be mutually agreed to. Manufacturer will provide Purchaser with monthly mean-time between failures data. Manufacturer will perform highly accelerated life testing and highly accelerated stress screens for each new Product, key component and subassembly produced by Manufacturer. Manufacturer agrees to comply in all respects with the Quality Standards and Reports set forth on Appendix C.
Manufacture of Products. Manufacture by CureVac of Products for use in preclinical activities during the Research Period will take place under the First Program Research Plan, the Reserved Target Research Plan and the Other Pre-IND Program Research Plans, as the case may be. For the supply of Products to be used in Clinical Phase I Studies with respect to the First Collaboration Program (including in relation to a Product based upon a Replacement Target Antibody), subject to Section 6.2, the Parties shall negotiate and enter into a clinical supply agreement under which CureVac shall Manufacture or have Manufactured such Products on Genmab’s behalf. For the supply of Products to be used in Clinical Phase I Studies with respect to any other Pre-IND Program, the Parties will on a Product-by-Product basis negotiate an amendment to the Early Clinical Supply Agreement in good faith, subject to Section 6.2, whereby CureVac shall Manufacture or have Manufactured such Product on Genmab’s behalf. For other Manufacture of Products, CureVac shall have the right to provide an offer to Genmab to Manufacture Product under the provisions of Section 6.4.
Manufacture of Products. DT and MYT agrees that MYT will manufacture Products for, upon the order of or on behalf of DT upon the written request or notification of DT, subject to the terms and conditions hereof, during the term of this Agreement and any renewal thereof.
