Batch Release. 3.1 Batch review and release to Client shall be the responsibility of Patheon who shall act in accordance with Patheon's standard operating procedures.
Batch Release. 3.1 The Contractor will manufacture and test the Product according to established, approved procedures and current Good Manufacturing Practices.
Batch Release. After Catalent completes Processing of a Batch, Catalent shall also provide Client or its designee with a Certificate of Analysis, Certificate of Origin, and a Certificate of Compliance for such Batch. Issuance of a Certificate of Analysis, Certificate of Origin, and a Certificate of Compliance by Catalent constitutes release of the Batch by Catalent to Client. Client shall be responsible for final release of Product, at its cost to the market. In addition, Catalent agrees to provide a Certificate of Analysis, a Certificate of Compliance, and a Certificate of Origin, for in process uncoated softgels.
Batch Release. UBI will provide to Siemens, or to an agreed upon notified body for products designated as Annex II by Directive 98/79/EC, copies of batch release documents, in English, for the initial shipment of each Product manufactured hereunder, or samples from such initial batch(es) to be tested by the notified body if required under the CE xxxx, prior to releasing the first shipment of each Product to Siemens hereunder.
Batch Release. 13.2.1. Therapure shall Manufacture ARIKACE in accordance with (i) cGMPs or any other applicable Laws; (ii) the applicable ARIKACE Permit (including the NDA) and Facility Permit; (iii) the ARIKACE Specifications; and (iv) the requirements set out in the Quality Agreement (clauses (i) through (iv) collectively, “Therapure’s Manufacturing Requirements”).
Batch Release. XXX shall ensure that each Product has been Manufactured in compliance with the requirements of the Registration and shall release only batches accompanied by a certificate of compliance and analysis signed by a qualified person of XXX that the Product has been Manufactured by XXX according to the Specifications and that XXX is committed to inform WCCI in the event of any change in the Manufacturing process or in the analytical specification, in accordance with the terms of this Agreement, and of any noted incident occurring during the Manufacture of the Product. In preparing the certificate of compliance and analysis, a qualified person of XXX shall take into account analytical results, essential information such as the production conditions, the results of in-process controls and the examination of Manufacturing documents. XXX shall create and retain records relating to each batch of the Product Manufactured hereunder in accordance with applicable Law.
Batch Release. LEO shall ensure that each Producx xas been Manufactured in compliance with the requirements of the Registration and shall release only batches accompanied by a certificate of compliance signed by a qualified person of LEO that the Product has xxen Manufactured by LEO according to the Specificatioxx and that LEO is committed to infoxx GALEN in the event of any change xx xxe manufacturing process or in the analytical specification, in accordance with the terms of this Agreement, and of any noted incident occurring during the Manufacture of the Product. In preparing the certificate of compliance, qualified person of LEO shall take into account analyxxxal results, essential information such as the production conditions, the results of in-process controls and the examination of manufacturing documents. LEO shall create and retain recorxx relating to each batch of the Product Manufactured hereunder in accordance with applicable Law.
Batch Release. After Catalent completes Processing of a Batch, Catalent shall also provide Client or its designee with Catalent's certificate of analysis for such Batch. Issuance of a certificate of analysis by Catalent constitutes release of the Batch by Catalent to Client. Client shall be responsible for final release of Product to the market (including any additional testing, as applicable), at its cost.
Batch Release. SUPPLIER shall be responsible for securing batch release relating to Product with a European Official Medicinal Control Laboratory and National Batch Release and shall provide DISTRIBUTOR with such relevant release documentation, information forms and certificates as specified in ANNEX E. DISTRIBUTOR shall be entitled to rely upon such information forms and certificates without the necessity of performing additional testing. DISTRIBUTOR is responsible for (at its cost and expense) and shall obtain and hold all necessary regulatory registrations regarding distribution in the Territory.
Batch Release. Provider shall be responsible for the technical release to 89bio of each Batch of 89bio Product Manufactured. The Batch of 89bio Product can be released once Provider has performed or has had performed under its supervision by an independent Third Party, all customary tests as per the Specifications and each of the 89bio Products meets the Specifications and Applicable Laws. As part of the release of each Batch of 89bio Product, Provider will provide 89bio with a Certificate of Analysis and a Certificate of Compliance. Provider agrees to further provide a copy of the Batch production records, a BSE/TSE statement and a Nitrosamine statement certifying that the 89bio Product does not contain, and was not Manufactured with, any animal products or any materials of animal origin and do not contain any Nitrosamines or precursors. [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
