Product Specifications; Testing. Product supplied hereunder shall conform to the Specifications and the warranty set forth in § 7.2. AFP or applicable qualified contract laboratories shall perform quality control testing and quality oversight on the Product to be delivered to MannKind or its designee hereunder.
Product Specifications; Testing. (a) The Parties agree and acknowledge that the Specifications will be developed and defined by Aviron after the Effective Date and following validation and qualification, subject to input, review and approval by PCI. Each Party agrees to act in good faith in defining and finalizing the Specifications. Once finalized, the Specifications will be appended to this Agreement as Appendix 3. The Parties further agree and acknowledge that the final piece price to be charged Aviron for the Product under Section 13.1. can be determined only after the final Specifications have been agreed upon. The Parties acknowledge that, once agreed upon, the Specifications set forth in Appendix 3 may need to be refined and modified as the Parties gain experience with [ * ] Production, testing and use of Product. Accordingly, the Parties agree to negotiate in good faith to modify Appendix 3 from time to time as the Parties' experience with Primary and Secondary Production, testing and use of Product warrant; and PCI further agrees that it will facilitate changes to Appendix 3 that are necessary or appropriate in light of FDA or other regulatory requirements. The Parties agree to allocate on an equitable basis any special costs of developing and implementing revised procedures.
(b) Product supplied hereunder will conform to the Specifications, and such conformance will be verified in accordance with the testing standards and procedures specified therein. PCI will forward a sample of each batch of Product to Aviron for testing and supply Aviron with a certificate of analysis ("Certificate of Analysis") confirming that such Product meets the Specifications.
Product Specifications; Testing. Oakwood will test each Batch of Product to be supplied to Edge hereunder in accordance with the testing standards and procedures set forth in the Specifications and issue to Edge a certificate of analysis confirming that such batch meets the Specifications. In addition, the quality assurance department of Oakwood will review the records relating to the Manufacture of such batch and will assess whether such Manufacture has taken place in compliance with cGMPs and the Master Batch Record. If, based upon such tests, a Batch of Product is determined to have been Manufactured according to cGMPs and the Master Batch Record, and then Oakwood’s quality assurance department shall issue a certificate of compliance for such Batch. The Specifications and a completed, signed and accurate copy of the Batch Record for each Batch of Product will be delivered to Edge by a reputable courier or by registered or certified mail, postage prepaid, with return receipt required to verify delivery date.
Product Specifications; Testing. Product supplied hereunder shall conform to the Specification as set forth in Exhibit A and the warranty set forth in § 8.2. Organon shall perform quality control testing and quality oversight on the Product to be delivered to Biodel or its designee hereunder.
Product Specifications; Testing. (a) Certain of the Packaging Specifications are appended to this Agreement as Appendix 2. The Parties acknowledge that those Packaging Specifications set forth in Appendix 2 which are specific to the Secondary Production under this Agreement, namely those procedures 211.MedImmune.1 through 211.MedImmune.12 and V0008 and V0014, may need to be refined and modified as the Parties gain experience with Secondary Production, testing and use of Product. Accordingly, the Parties agree to negotiate in good faith to modify those MedImmune specific procedures from time to time as the Parties' experience with Secondary Production, testing and use of Product warrant; and Cardinal Health further agrees that it will facilitate changes to Appendix 2 that are necessary or appropriate in light of FDA or other regulatory requirements. The Parties agree to allocate on an equitable basis any special costs of developing and implementing revised procedures.
(b) Product supplied hereunder will conform to the Packaging Specifications, and such conformance will be verified in accordance with the testing standards and procedures specified therein. Cardinal Health will forward a sample of each batch of Product to MedImmune for testing and will supply MedImmune with a certificate of release ("Certificate of Release") confirming that such Product produced meets the Packaging Specifications.
(c) The Parties agree to work together in good faith to develop more efficient packaging and testing procedures.
Product Specifications; Testing. Oakwood will test each Batch of Product to be supplied to Edge hereunder in accordance with the testing standards and procedures set forth in the Specifications and, if a Batch of Product meets the Specifications therefor, Oakwood will issue to Edge a certificate of analysis confirming that such Batch meets such Specifications. The Specifications and a completed, signed and accurate copy of the Batch record for each Batch of Product will be delivered to Edge by such method as mutually agreed in writing by the Parties. 3.4
Product Specifications; Testing. All Products supplied hereunder will be manufactured in accordance with the applicable Specifications and (except to the extent otherwise specified in a Work Order) cGMPs, and shall conform to the applicable Specifications. CoreRx shall test each batch of Product in accordance with the testing standards and procedures set forth in the Specifications and supply Client with a certificate of analysis (“Certificate of Analysis”) confirming that such batch conforms to the Specifications applicable to such Product. Client shall be entitled to rely on the Certificate of Analysis and, upon delivery of such Product, Client may then retest the batch of Product as more fully set forth in Article 6 to confirm that it meets such Specifications, but Client is not required to perform any further testing of such Product. The parties acknowledge that the Specifications for a Product may need to be refined and modified as the parties gain experience with the manufacture, testing and use of such Product or as necessary to comply with FDA, EMEA or other regulatory requirements. Accordingly, Client and CoreRx agree to negotiate in good faith to modify the Specifications from time to time as appropriate. Significant modifications may be subject to additional Work Orders or applicable addendums as agreed upon in writing by both parties.
Product Specifications; Testing. Supplier shall perform design verification and design validation of the Products in accordance with 21 C.F.R. Part 820. Products supplied hereunder will conform to the Specifications (as amended from time to time by written agreement between the Parties). Supplier shall perform quality control testing and quality oversight on Products to be delivered to Suneva or its designee hereunder in accordance with the Specifications and cGMPs. The Parties agree that, should Suneva wish to implement any amendment to the Specifications, Suneva shall provide written notice thereof to Supplier for Supplier’s review and approval, which approval shall not be unreasonably withheld. Supplier further agrees that it will facilitate changes to the Specifications that are necessary or appropriate in light of FDA or other regulatory requirements. Unless required by Applicable Law, Supplier will not change the Specifications for any Product without the prior consent of Suneva.
Product Specifications; Testing. (a) Finished Products supplied hereunder will conform to the Specifications set forth in Exhibit A (as amended from time to time by written agreement between the Customer and Manufacturer) and such conformance will be verified in accordance with the testing standards and procedures specified therein. Customers and Manufacturer acknowledge that the Specifications and testing procedures set forth in Exhibit A may need to be refined as the Parties gain experience with the manufacture, testing and use of Finished Product.
(b) Manufacturer will test each batch of Finished Product and supply Customer with a certificate of analysis ("Certificate of Analysis") confirming that such batch meets the Specifications. Customer shall qualify Manufacturer for autonomy of release according to Customer's protocol.
(c) Any out-of-specification results upon testing of Finished Product must be investigated and documented by Manufacturer. Manufacturer will notify Customer immediately of the results of investigation with justification for retest, if any. Manufacturer will then confer with Customer as to what course of action to take prior to proceeding.
(d) Future modifications may be made to the testing procedures as requested by Customer. Customer and Manufacturer shall negotiate the cost of any such modification.
Product Specifications; Testing. All Product supplied hereunder will conform to the Specifications at the time of delivery and shall have a remaining shelf life of not less than [***] from the date of delivery to 3SBio. AMAG will test each batch of Product in accordance with the Acceptance Tests and supply 3SBio with a certificate of analysis (“Certificate of Analysis”) confirming that such batch meets the Specifications. 3SBio may then retest the batch of Product as more fully set forth in Section 5.5 to confirm that it meets the Specifications. The Parties acknowledge that the Specifications and Acceptance Tests may need to be refined and modified as the Parties gain experience with the manufacture, testing and use of Product. Accordingly, the Parties agree to negotiate in good faith to modify the Specifications and Acceptance Tests from time to time as the Parties’ experience with the manufacture, testing and use of the Product warrants. 3SBio acknowledges that AMAG may be required to modify the Specifications in light of regulatory requirements imposed by the FDA or other Regulatory Authority, and that 3SBio may not unreasonably withhold its agreement from any such modifications. If any regulatory requirement imposed by the SFDA would require a change to the Specifications or the Acceptance Tests, the Parties will promptly discuss such change and negotiate amendments to the Specifications or the Acceptance Tests in good faith. The Parties agree to allocate on an equitable basis any costs of developing and implementing revised procedures in response to SFDA requirements.
