Active Materials and Qualification of Additional Sources of Supply. Client will at its sole cost and expense, deliver the Active Materials to Patheon (in accordance with Section 2.1(f)). If applicable, Patheon and the Client will reasonably cooperate to permit the import of the Active Materials to the Manufacturing Site. Client’s obligation will include obtaining the proper release of the Active Materials from the applicable Customs Agency and Regulatory Authority. Client or Client’s designated broker will be the “Importer of Record” for Active Materials imported to the Manufacturing Site. The Active Materials will be held by Patheon on behalf of Client as set forth in this Agreement. The Active Materials will at all times remain the property of Client. Patheon will ensure that the Active Materials will not become subject to any encumbrances, liens or other third-party claims while in Patheon’s possession. Any Active Materials received by Patheon will only be used by Patheon to perform the Manufacturing Services. If Client asks Patheon to qualify an additional source for the Active Material or any Component, Patheon will evaluate the Active Material or Component to be supplied by the additional source to determine if it is suitable for use in the Product. The Parties will agree on the scope of work to be performed by Patheon at Client’s cost. For an Active Material, this work at a minimum will include: (a) laboratory testing to confirm the Active Material meets existing specifications; (b) manufacture of an experimental Batch of Product that will be placed on three months accelerated stability; and (c) manufacture of three full-scale validation Batches that will be placed on concurrent stability (one Batch may be the registration Batch if manufactured at full scale).
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Samples: Master Manufacturing Services Agreement (Acadia Pharmaceuticals Inc), Master Manufacturing Services Agreement (Acadia Pharmaceuticals Inc), Master Manufacturing Services Agreement (Acadia Pharmaceuticals Inc)
Active Materials and Qualification of Additional Sources of Supply. Client will will, at its sole cost and expense, deliver the Active Materials to Patheon (in accordance with Section 2.1(f))) sufficient for Patheon to manufacture the desired quantities of Product. If applicable, Patheon and the Client will reasonably cooperate to permit the import of the Active Materials to the Manufacturing Site. Client’s obligation will include obtaining the proper release of the Active Materials from the applicable Customs Agency customs agency and Regulatory Authority, as applicable. Client or Client’s designated broker agent will be the “Importer of Record” for Active Materials imported to the Manufacturing Site. The Active Materials will be held by Patheon on behalf of Client as set forth in this Agreement. The Active Materials will at all times remain the property of Client. Patheon will ensure that the Active Materials will not become subject to any encumbrances, liens or other third-party claims while in Patheon’s possession. Any Active Materials received by Patheon will only be used by Patheon to perform the Manufacturing Services. If Client asks Patheon to qualify an additional source for the Active Material or any Component, Patheon will cooperate with Client to evaluate the Active Material or Component to be supplied by the additional source to determine if it is suitable for use in the Product. The Parties parties will agree on the scope of work to be performed by Patheon at Client’s cost. For an Active Material, this work at a minimum will include:
(a) laboratory testing to confirm the Active Material meets existing specifications;
(b) manufacture Specifications;manufacture of an experimental Batch a GMP qualification batch of Product that will be placed on three months accelerated stability; and.
(cb) If applicable, manufacture of three full-scale validation Batches batches that will be placed on concurrent stability (one Batch batch may be the registration Batch batch if manufactured at full scale).
Section 2.1 (k) will apply to all Product manufactured using the newly approved Active Material or Component because of the limited material characterization that is performed on additional sources of supply.
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Samples: Master Manufacturing Services Agreement (Jaguar Animal Health, Inc.), Master Manufacturing Services Agreement (Jaguar Animal Health, Inc.)