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. 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. 7.1 MIPI shall receive the Confirmation by a Qualified Person (EU GMP Annex 16) of batch release as set forth in Appendix 5.
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. 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.
3.2 For each batch released by Patheon for shipment to the Client, Patheon shall deliver to the Client a certificate of analysis/certificate of compliance, which shall include a statement that the batch has been manufactured in accordance with cGMPs and the Specifications. The Client shall have sole responsibility for release of the Product to the market.
3.3 Patheon shall notify the Client in the event of (i) any major deviation during manufacture which affects the quality or efficacy of the Product or (ii) a confirmed OOS result.
Batch Release. 3.1 The Contractor will manufacture and test the Product according to established, approved procedures and current Good Manufacturing Practices.
3.2 Batch review and release of the Product and all of its components will be the sole responsibility of the Contractor.
3.3 The Contractor will have a formal retest policy and procedure in place that is in accordance with applicable regulations.
3.4 The Contractor will notify NA, within 48 hours, in the event that any test reveals contamination, lack of sterility, or degradation beyond specifications in any batch of Product. The Contractor will file any reports required by the applicable regulations.
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. After Catalent completes Processing of a Batch, Catalent shall also provide Client or its designee with Catalent’s certificate of analysis and certificate of compliance for such Batch. Issuance of a certificate of analysis 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 to the market. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO THE CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED AS [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.EXECUTION VERSION
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. LEO 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 signed by a qualified person of LEO that the Product has been Manufactured by LEO according to the Specifications and that LEO is committed to inform GALEN 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, qualified person of LEO 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. LEO shall create and retain records relating to each batch of the Product Manufactured hereunder in accordance with applicable Law.
