Testing and Approval. Seller shall be responsible, at its sole cost and expense, for testing Plasma in accordance with FDA and EMEA requirements and the Specifications. Seller shall be responsible for qualifying appropriate testing centers. Seller shall send all Plasma to be provided to Buyer pursuant to this Agreement only to Approved Testing Centers. However, Seller may send Plasma to an alternative laboratory upon the approval of Buyer, which shall not be unreasonably withheld. With respect to each shipment of Plasma to be shipped to Buyer, Seller shall test such Plasma to ensure compliance with the Specifications, Applicable Laws and Regulatory Approvals, and warranties as set forth in Section 8.2. Seller shall include a certificate of analysis and certificate of compliance, as well as all other documentation described in the Specifications, with each shipment of Plasma disclosing the results of such testing and certifying conformance with the Specifications and other requirements. Buyer may reject any Plasma after review of the accompanying documentation or upon inspection after receipt by Buyer or Buyer’s designee if such Plasma is not in compliance with the Specifications or any warranty hereunder. Buyer shall *** each shipment of Plasma received from Seller and the associated documentation and shall notify Seller in writing in the event of Buyer intends to rejects such shipment within *** business days after receipt. In the case of Plasma with defects not readily discoverable during inspection upon receipt by Buyer, Buyer shall notify the Seller of such defects *** following Buyer’s discovery thereof and shall be entitled to reject such Plasma. Rejected Plasma will be destroyed in compliance with Buyer’s internal procedures and local environmental requirements. Seller reserves the right to *** the *** concerning the *** of ***.
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Sources: Strategic Supply Agreement (Viropharma Inc), Strategic Supply Agreement (Viropharma Inc)
Testing and Approval. Seller shall be responsible, at its sole cost and expense, for testing Plasma in accordance with FDA and EMEA requirements and the Specifications. Seller shall be responsible for qualifying appropriate testing centers. Seller shall send all Plasma to be provided to Buyer pursuant to this Agreement only to Approved Testing Centers. However, Seller may send Plasma to an alternative laboratory upon the approval of Buyer, which shall not be unreasonably withheld. With respect to each shipment of Plasma to be shipped to Buyer, Seller shall test such Plasma to ensure compliance with the Specifications, Applicable Laws and Regulatory Approvals, and warranties as set forth in Section 8.2. Seller shall include a certificate of analysis and certificate of compliance, as well as all other documentation described in the Specifications, with each shipment of Plasma Plasma, disclosing the results of such testing and certifying conformance with the Specifications and other requirements. Buyer may reject any Plasma Plasma, after review of the accompanying documentation or upon inspection after receipt by Buyer or Buyer’s designee designee, if such Plasma is not in compliance with the Specifications or any warranty hereunder. Buyer shall *** each shipment of Plasma received from Seller and the associated documentation and shall notify Seller in writing in the event of that the Buyer intends to rejects such shipment within *** ten (10) business days after receipt. In the case of Plasma with defects not readily discoverable during inspection upon receipt by Buyer, Buyer shall notify the Seller of such defects *** following Buyer’s discovery thereof and shall be entitled to reject such Plasma. Rejected Plasma will be destroyed in compliance with Buyer’s internal procedures and local environmental requirements. Seller reserves the right to *** the *** concerning the *** of ***.
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