Common use of Certificate of Analysis Clause in Contracts

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.

Appears in 4 contracts

Samples: Supply Agreement (Progenics Pharmaceuticals Inc), Supply Agreement (Progenics Pharmaceuticals Inc), Supply Agreement (Progenics Pharmaceuticals Inc)

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Certificate of Analysis. NON-COMPLYING KLHBCG. Before, during and after Manufacture of KLH BCG Requirements, PerImmune as applicable, Teknika 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 Teknika shall test each lot of KLH requirements Manufactured BCG Requirements manufactured for Progenics CancerVax or as required under the Specifications. Together with each such lot of KLH BCG Requirements, PerImmune Teknika shall provide a written certificate of analysis which shall set forth the results of such testing by PerImmune Teknika and PerImmuneTeknika's quality control approval of such lot of KLH BCG Requirements. PerImmuneTeknika's obligations under this section 2.3(cSection 2.3(d) shall be performed at PerImmuneTeknika's sole expense. Progenics CancerVax shall be entitled to test any such KLH BCG Requirements in accordance with the Specifications, at Progenics' CancerVax's sole expense. Without limiting any of Progenics' CancerVax's other rights or remedies under this Agreement with respect to any KLH BCG Requirements supplied hereunder that do not comply with applicable representations and warranties under this Section 2.3, and provided PerImmune Teknika reasonably confirms Progenics' CancerVax's test results, the Parties agree that; (i) Progenics CancerVax shall not be obligated to pay PerImmune Teknika the transfer price applicable to such non-complying KLH BCG Requirements; (ii) if Progenics CancerVax has already paid for such non-complying KLH BCG Requirements, Progenics CancerVax shall be entitled to a credit against future purchases for the amount paid to PerImmune Teknika therefor; (iii) PerImmune Teknika shall, on a priority basis, Manufacture and supply to ProgenicsCancerVax, as applicable, replacement KLH BCG Requirements in full compliance with this Section 2.3; and (iv) PerImmune Teknika shall bear the full reasonable cost of returning or destroying the non-non- complying KLH BCG Requirements. *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

Appears in 1 contract

Samples: Supply Agreement (Cancervax Corp)

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Certificate of Analysis. NON-COMPLYING KLHBCG. Before, during and after Manufacture of KLH BCG Requirements, PerImmune as applicable, Teknika 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 Teknika shall test each lot of KLH requirements Manufactured BCG Requirements manufactured for Progenics CancerVax or as required under the Specifications. Together with each such lot of KLH BCG Requirements, PerImmune Teknika shall provide a written certificate of analysis which shall set forth the results of such testing by PerImmune Teknika and PerImmuneTeknika's quality control approval of such lot of KLH BCG Requirements. PerImmuneTeknika's obligations under this section 2.3(cSection 2.3(d) shall be performed at PerImmuneTeknika's sole expense. Progenics CancerVax shall be entitled to test any such KLH BCG Requirements in accordance with the Specifications, at Progenics' CancerVax's sole expense. Without limiting any of Progenics' CancerVax's other rights or remedies under this Agreement with respect to any KLH BCG Requirements supplied hereunder that do not comply with applicable representations and warranties under this Section 2.3, and provided PerImmune Teknika reasonably confirms Progenics' CancerVax's test results, the Parties agree that; (i) Progenics CancerVax shall not be obligated to pay PerImmune Teknika the transfer price applicable to such non-complying KLH BCG Requirements; (ii) if Progenics CancerVax has already paid for such non-complying KLH BCG Requirements, Progenics CancerVax shall be entitled to a credit against future purchases for the amount paid to PerImmune Teknika therefor; (iii) PerImmune Teknika shall, on a priority basis, Manufacture and supply to ProgenicsCancerVax, as applicable, replacement KLH BCG Requirements in full compliance with this Section 2.3; and (iv) PerImmune Teknika shall bear the full reasonable cost of returning or destroying the non-non- complying KLH BCG Requirements.

Appears in 1 contract

Samples: Supply Agreement (Cancervax Corp)

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