Manufacturing of the Products. Bayer shall manufacture, process, store, distribute, test, transport, dispose, deliver and otherwise handle the Products and the Inputs at all times in full compliance with, as applicable, cGMPs (as defined in Section 5.1), other Regulations (as defined in Section 5.1), the Product Specifications, the Manufacturing Agreement (for manufacturing Fraction IV-I/PEG Paste into the Column Eluate), attached hereto as Exhibit F and incorporated herein by reference, the Manufacturing Agreement (for manufacturing Fraction IV-I Paste into ATIII), attached hereto as Exhibit G and incorporated herein by reference, and the SOPs (as ***CONFIDENTIAL TREATMENT REQUESTED defined in Section 2.13). The Manufacturing Agreements for manufacturing Fraction IV-I/PEG Paste into the Column Eluate and Fraction IV-I Paste into ATM shall be renewed annually, consistent with the Term of this Agreement, with each such renewal deemed attached hereto as Exhibit F and Exhibit G, respectively, and incorporated herein by reference. In the event of a conflict between the provisions of this Agreement and the provisions of either of the Manufacturing Agreements, the provisions of this Agreement shall prevail. Bayer shall maintain all records as are necessary and appropriate to demonstrate compliance with cGMPs and the Regulations. In no event shall any change to the batch production records be implemented until Bayer has received written approval from Purchaser which approval will not be unreasonably withheld. Bayer shall make no changes in the production equipment, production procedures, or testing methods existing as of the date of this Agreement. without providing reasonable notice to Purchaser in advance of the change and obtaining Purchaser’s prior written consent which consent will not be unreasonably withheld.
Manufacturing of the Products. Greatbatch is responsible for material compliance with Applicable Laws regulating the manufacture of the Products by Greatbatch under this Agreement. Without limiting the generality of the foregoing, the Products delivered to NeuroPace under this Agreement will be manufactured in material conformance with current revisions of ISO 9001 or ISO13485, as applicable. Subject to the non-disclosure requirements of Section 10.1, Greatbatch will provide reasonable access, at a mutually agreed upon date and time, for NeuroPace’s regulatory and quality personnel to (a) the portion of Greatbatch’s facilities used for the manufacture of Products pursuant to this Agreement and (b) the records of Greatbatch related to Products manufactured under this Agreement. The purpose of this reasonable access is to confirm Greatbatch’s compliance in the manufacture of the Products under this Agreement with any applicable requirements noted in this Section 4.1. Greatbatch will advise NeuroPace promptly of any material written report, recommendation, violation, citation or other adverse information provided to Greatbatch by an agent or representative of any national or international authority visiting or inspecting Greatbatch’s operations related to assembly and manufacture of the Products. Greatbatch will keep all required manufacturing records for each lot of Products for the period of time required by Applicable Laws.
Manufacturing of the Products. Greatbatch is responsible for compliance with Applicable Laws regulating the manufacture of the Products by Greatbatch under this Agreement. Without limiting the generality of the foregoing, the Products delivered to Customer under this Agreement will be manufactured in conformance with current revisions of ISO 9001. Subject to the non-disclosure requirements of Section 9.1, Greatbatch will provide reasonable access, at a mutually agreed upon date and time, for Customer’s regulatory and quality personnel to (a) the portion of Greatbatch’s facilities used for the manufacture of Products pursuant to this Agreement and (b) the records of Greatbatch related to Products manufactured under this Agreement. The purpose of this reasonable access is to confirm Greatbatch’s compliance in the manufacture of the Products under this Agreement with any applicable requirements noted in this Section 4.1. Greatbatch will advise Customer promptly of any written report, recommendation, violation, citation or other adverse information provided to Greatbatch by an agent or representative of any government authority visiting or inspecting Greatbatch’s operations related to assembly and manufacture of the Products. Greatbatch will keep all required manufacturing records for each lot of Products for the period of time required by Applicable Laws.
Manufacturing of the Products. (a) Seller or its Affiliates shall use commercially reasonable efforts to manufacture Products at the same level of quality as the Products were manufactured immediately prior to the Effective Date.
Manufacturing of the Products. 1.1.2 Procuring the Components necessary for the Manufacturing
Manufacturing of the Products. 4.1 cGMP. Seller and its Affiliates shall Manufacture and supply the Products to Buyer at all times in full compliance with the Act, cGMP and any other applicable Regulatory Requirements. Seller and its Affiliates shall maintain during the Term of this Agreement and for a period thereafter consistent with Seller’s policies and standard cGMP requirements, all records as are necessary or appropriate to demonstrate compliance with the Act, cGMP and any other applicable quality control standards of any Regulatory Authority in the Territory. If Seller fails to comply with cGMPs in a manner, as demonstrated by an observation of a Regulatory Authority, Seller shall diligently proceed to remedy such deviation in accordance with Seller’s response to the observation.
Manufacturing of the Products. 5.1 Manufacturing. Company agrees to manufacture and sell the Products to -------------- Distributor subject to the terms and conditions set forth herein.
Manufacturing of the Products. Collegium shall exclusively (even as to Collegium) Manufacture and supply Hikma with, and Hikma shall exclusively purchase from Collegium, all of the quantities of the Products which Hikma requires to be sold in the Territory. As soon as reasonably practicable, and in [***], the Parties shall negotiate in good faith and enter into the Manufacturing Agreement, which will include provisions addressing remedies for failure to supply, supply deficiencies, and back-up/alternate manufacturing and other customary terms pertaining to the manufacturing and supply of the Products, and any and all agreements contemplated thereunder providing for manufacture and supply by Collegium of the Products to Hikma in finished dosage form, packaged and labeled for commercial sale in the Territory.
Manufacturing of the Products. Subject to the provisions of Section 10 hereof, Xxxxxx will manufacture and package quality Products for sale to Xxxxxxx pursuant to the agreed upon formulations and specifications and will use its best efforts to control its cost of manufacturing consistent with the quality specifications for the Products. Xxxxxx will devote to such manufacturing all equipment owned or leased by Xxxxxx necessary for the production of the Products, and the services of all Xxxxxx employees necessary for such production.
Manufacturing of the Products
