Testing and Release. Encap shall be responsible for and shall conduct quality assurance and quality control functions, including identity testing of API and additional testing of API if agreed to by the Parties as set forth in Section 5.1, and at Customer’s expense, testing of raw materials, oversight of manufacturing process, release testing of Product, stability testing of Product, and maintaining of reference standards as set forth in the Quality Agreement.
Testing and Release. Testing and release of the Product shall be undertaken in accordance with the terms of the Product Quality Agreement. Aptalis shall be responsible for final release of the Product, which shall be in accordance with the Product Quality Agreement.
Testing and Release. Upon receipt of starting materials for Manufacturing, the shipping containers must be checked by Unigene for: Completeness and accuracy of material shipment External condition Intact and authentic seal Identity of material Unigene must maintain records of each batch of starting material used in Manufacturing consisting of quantity delivered, usage of each batch, and investigation into any discrepancy. If Unigene orders starting materials for use in Manufacturing, Unigene is responsible for testing and release of material according to agreed upon test methods and specifications.
Testing and Release. SDI shall conduct all testing of the Licensed Products prior to delivery of Licensed Products hereunder, which testing is required for release of the Licensed Products. As Regulatory Approval holder, Avigen is responsible for release of the Licensed Product to the market. Avigen is entitled to do so, however, in reliance on the written documentation that SDI provides Avigen in accordance with these Supply Terms. Avigen is responsible for any liability for release to the market by Avigen, its Affiliates, Sublicensees, and Distributors of quantities of Licensed Product that, based on the written documentation provided by SDI, is defective. SDI is responsible for any liability arising out of (a) SDI’s provision of written documentation that is inaccurate as to the test results and/or procedures used to manufacture Licensed Product delivered hereunder, and/or (b) SDI’s failure to manufacture in accordance with the standards required by these Supply Terms, where such failure was not explicitly documented in the written documentation provided to Avigen under these Supply Terms.
Testing and Release. Testing and release of the Product shall be made in accordance with Exhibit B, which is subject to Regulatory Approval, any amendments thereto and/or any changes to the Japanese pharmacopoeia. During the Term, Sucampo will conduct the commercial stability program with respect to the Product pursuant to Applicable Law, at its own expense.
Testing and Release. (a) Protiva shall perform all Raw Material release testing, in-process testing and Finished Product release testing in accordance with the test parameters set forth in the applicable Specifications. If at any time during the Raw Material release testing of Dicerna Materials, Protiva discovers that the whole or part of a Batch of Dicerna Materials does not meet the acceptance criteria set forth in the applicable Specifications, Protiva shall notify Dicerna in writing by ***** to provide sufficient details to enable Dicerna to order replacement shipments of relevant Dicerna Materials.
(b) All GMP Batches shall be released by Protiva’s Quality Assurance representative before shipment to Dicerna.
(c) If Dicerna requests stability studies to be performed on a Manufactured Product by way of an SOW, Protiva shall design and Dicerna shall approve a study protocol and applicable SOPs to be used by Protiva.
Testing and Release. Prior to delivery of Products, Healeon will undertake quality control and release of each lot of Products using the testing methodologies set forth in the Specifications or as otherwise agreed upon in writing by Suneva and Healeon for purposes of this Agreement.
Testing and Release. 8 6.5 STORAGE.............................................................. 8 7
Testing and Release. Every batch of starting materials used at NOVARTIS must be released for production of LdT Finished Products and be in compliance with the specifications. Starting materials procured by NOVARTIS must be tested for compliance with the said Specifications and released for production by NOVARTIS.
Testing and Release. Prior to delivery of Finished Product, Alpex will undertake quality control and release of each lot of Finished Product using the testing methodologies set forth in the Specifications or as otherwise agreed upon in writing by Company and Alpex for purposes of this Agreement, and as required by cGMP, other Applicable Law and Regulatory Requirements.
