Certificate of Analysis. Seller shall provide a certificate of analysis and other documents as defined in the Quality Agreement for any Product to be released hereunder, in a form in accordance with the cGMPs and all other applicable Regulatory Requirements and Product Specifications and as shall be agreed upon by the parties. For any batch that initially failed to meet any Product Specification, the certificate of analysis shall document the exception. Products that do not meet dissolution specifications at USP Stage I and II testing shall not be accepted by Buyer (and such requirement shall be included in the Product Specifications/Quality Manual).
Certificate of Analysis. NON-COMPLYING KLH. Before, during and after Manufacture of KLH Requirements, PerImmune shall obtain samples, monitor the Manufacturing Process and the environment of such Manufacture, and keep such technical books and records of all of the foregoing as are required under the Specifications and Procedures and all applicable laws and regulations, including but not limited to cGLPs or cGMPs (as appropriate and applicable). PerImmune shall test each lot of KLH requirements Manufactured for Progenics or as required under the Specifications. Together with each such lot of KLH Requirements, PerImmune shall provide a written certificate of analysis which shall set forth the results of such testing by PerImmune and PerImmune's quality control approval of such lot of KLH Requirements. PerImmune's obligations under this section 2.3(c) shall be performed at PerImmune's sole expense. Progenics shall be entitled to test any such KLH Requirements in accordance with the Specifications, at Progenics' sole expense. Without limiting any of Progenics' other rights or remedies under this Agreement with respect to any KLH Requirements supplied hereunder that do not comply with applicable representations and warranties under this Section 2.3, and provided PerImmune reasonably confirms Progenics' test results, the Parties agree that; (i) Progenics shall not be obligated to pay PerImmune the transfer price applicable to such non-complying KLH Requirements; (ii) if Progenics has already paid for such non-complying KLH Requirements, Progenics shall be entitled to a credit against future purchases for the amount paid to PerImmune therefor; (iii) PerImmune shall, on a priority basis, Manufacture and supply to Progenics, as applicable, replacement KLH Requirements in full compliance with this Section 2.3; and (iv) PerImmune shall bear the full cost of returning or destroying the non-complying KLH Requirements.
Certificate of Analysis. Each shipment of the Product to Purchaser shall be accompanied by a certificate of analysis prepared by an authorized representative of Seller certifying that the Product in the shipment has been tested in accordance with the ANDA for such Product, meets the Specifications and was manufactured in material compliance with cGMP (for the avoidance of doubt any non-compliance that would affect Purchaser’s sale or distribution of the Product hereunder shall be considered material). Seller shall deliver such certificate of analysis by facsimile or overnight delivery to Purchaser’s distribution facility as designated by Purchaser.
Certificate of Analysis. An appropriate Certificate of Analysis and all relevant batch records shall precede the shipment of each Bulk Product batch delivered to Savient. BTG shall, for customs purposes, upon delivery of the Bulk Product, provide Savient with a valid declaration of origin, in a form reasonably acceptable to Savient, in respect of all Bulk Product supplied to Savient under this Agreement, together with such other supporting documents relating to the origin of such Bulk Product as Savient may reasonably require. If any of the foregoing documents are only available in a language other than English, the Parties shall agree upon an English language template for such document(s), and BTG shall provide to Savient an English language translation of any deviations from the template(s); provided, however, that any documentation required by any Regulatory Authority to be supplied for the purpose of importing, exporting, selling, storing, transferring, or otherwise disposing of Bulk Product, shall be provided in the English language.
Certificate of Analysis. With each delivery of the Product into Consignment Inventory pursuant to Section 7.3 or to Celltech from other than Consignment Inventory, Orphan Medical shall provide to Celltech (i) a Certificate of Analysis and Certificate of Conformity confirming that the Product has been manufactured in accordance with cGMP and the Product Specifications, (ii) a copy of all batch documentation from the Product manufacturer for the first three (3) batches of Product delivered to Celltech and (iii) a copy of the annual stability test report, provided that the provision of the certificates and other documents listed in (i) - (iii) above shall not release Celltech from any of its obligations hereunder, including, without limitation, its obligation to conduct all necessary release testing to ensure that the Products distributed in the Territory comply with all applicable regulatory requirements in the Territory.
Certificate of Analysis. Concurrent with shipment, PERIMMUNE shall fax to MENTOR a Certificate of Analysis, in the form set forth in Exhibit B, for each lot of Product sold to MENTOR, confirming that the Product meets the Quality Specifications.
Certificate of Analysis. Every shipment of the Products to Novartis shall be accompanied by a Certificate of Analysis from LecTec to certify the active ingredients therein. LecTec shall warrant the accuracy of each such Certificate of Analysis to a reasonable degree of scientific certainty.
Certificate of Analysis. Orion shall deliver with each shipment of Product a certificate of analysis, accompanied by a statement that the batch was manufactured according to the Quality Assurance Agreement, together with any other batch related records specified in the Quality Assurance Agreement. Without limitation, the certificate of analysis shall set forth the items tested, specifications and test results for each lot delivered, all in a manner which complies with the NDA, the Act and other applicable laws and regulatory requirements. Batch records for that THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. shipment (including all deviation reports and investigations) will, within seven (7) working days after release of the Product, be shipped to USL’s Quality Assurance Unit for review.
Certificate of Analysis. Each delivery of the Product will be accompanied by a Certificate of Analysis from Mayne Pharma in respect of the Product so delivered.
Certificate of Analysis. Each cGMP Delivery shall be accompanied by a written certification of Cardinal Health setting forth the measured and observable characteristics of the Delivery, as required by the Specifications, together with a certification of the Delivery’s compliance with cGMPs, cGLPs and FDA guidance documents (to the extent applicable), and any description of any departures from any of the foregoing (the “Certificate”). Non-cGMP Deliveries shall be accompanied by a written product information sheet, the content of which shall be mutually agreed between the parties.
