Manufacturing Facility. In manufacturing any Products, Supplier shall maintain an organization and facilities, including, without limitation, suitable equipment and tools, in accordance with standards generally accepted in the industry, and employ adequately trained and competent personnel in all functions. Supplier will keep complete and accurate records in all material respects with respect to Products it manufactures pursuant to this Agreement. Supplier shall, upon S&W’s request from time to time by providing at least 7 days prior notice, allow S&W or its representatives access to Supplier’s facilities to inspect the manufacture and assembly of the Products during reasonable hours, and provide S&W with such records in the possession of Supplier, as S&W may reasonably request, relating to the manufacture of Products and the source of any raw materials and components used in the Products; provided, however, in no event shall such inspection interfere with the business of Supplier.
Manufacturing Facility. Patheon will manufacture Finished Product at the Facility. Patheon shall not manufacture any Finished Product in any other facility without first obtaining Santarus' prior written consent, such consent not to be unreasonably withheld.
Manufacturing Facility. Capricorn shall manufacture the Product for Primus at the Manufacturing Facility, provided, however, that Capricorn may manufacture and package, or contract with a third party to manufacture and package, the Product at an alternative facility upon not less than thirty (30) days written notice to Primus, specifying the owner and location of the facility. Capricorn shall be responsible for ensuring that such other facility, and any manufacturing of the Product therein, complies in all respects with the representations, warranties, covenants and agreements contained herein that are applicable to the Manufacturing Facility and the manufacture and packaging of the Product by Capricorn (except for representations that relate to the ownership of the Manufacturing Facility by Capricorn).
Manufacturing Facility. (a) At all times during the Term, Capricorn shall maintain the Manufacturing Facility, equipment and processes used in producing the Product in strict compliance with all Applicable Laws and cGMP.
Manufacturing Facility. Prior to the manufacture of any Enzyme, on an Enzyme-by-Enzyme basis, the Parties shall agree upon the Manufacturing Facility for manufacture of such Enzyme. All such Enzyme shall be manufactured at such agreed upon Manufacturing Facility, and Company shall not, without Codexis’ prior written consent, not to be unreasonably withheld, manufacture such Enzyme at any facility other than such Manufacturing Facility. Prior to the delivery of any Batch of such Enzyme to Codexis or its Third Party designee, all such Batches shall be stored in accordance with the Quality Agreement and the applicable Specification, or as otherwise instructed in writing by Codexis, and at such Manufacturing Facility. Codexis and/or its Third Party designee shall have the right to inspect the Manufacturing Facilities and/or documentation related to the manufacture of Enzyme as set forth in the Quality Agreement.
Manufacturing Facility. The Project will be a manufacturing facility as defined in Section 144 (a) (12) of the Code. The Project may include ancillary facilities which are directly related and ancillary to the Project but any such ancillary facilities will be located on the same site as the Project and not more than 25% of the net proceeds of the Bonds will be used to provide such ancillary facilities.
Manufacturing Facility. As of the Effective Date, the Manufacturing Facility is deemed to be Catalent [*]. As of the Effective Date, the Manufacturing Facility has any and all Regulatory Approvals required for the Manufacture, Labeling, packaging, and exportation of the Product in accordance with the Specifications, cGMP and Applicable Laws, and thereafter the Company will use [*] to ensure that the Manufacturing Facility shall maintains any and all such Regulatory Approvals.
Manufacturing Facility. The Key Product is manufactured at the Xxxxxxx-Xxxxx Squibb Srl manufacturing facility located in Anagni, Italy (the “Manufacturing Facility”) and, to the Knowledge of the Company, the Key Product is manufactured in compliance with all applicable Laws and in conformity with Good Manufacturing Practices, including, but not limited to, the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 210 and 211, and any foreign equivalents, except as has not and would not reasonably be expected to materially and adversely affect the ability of the Company to package, promote, distribute, market, use or sell the Key Product. To the Knowledge of the Company, no event has occurred since January 1, 2012, and no event is reasonably expected to occur, that would materially and adversely affect the ability of the Company to procure the Key Product from the Manufacturing Facility on terms consistent in all material respects with those in effect prior to the date hereof and in quantities consistent in all material respects with past practice and sufficient for the operation of the Company’s business as currently conducted and as currently anticipated to be conducted.
Manufacturing Facility. Supplier shall manufacture all Product supplied to Purchaser pursuant to this Agreement at the Manufacturing Facility.
Manufacturing Facility. The Work shall be performed at Flextronics’ manufacturing facility located in Tijuana, Mexico (hereinafter the “Manufacturing Site”). A change in the Manufacturing Site is a major change and may require approval from the applicable governmental or regulatory authority, and therefore, Flextronics will provide [****] prior to changing the Manufacturing Site and will develop a transition plan with Customer in good faith. Flextronics will not implement the change in the Manufacturing Site until it receives written notification from Customer that such change can be implemented. Flextronics will be responsible for all costs and expenses associated with changing the Manufacturing Site.
