Common use of Certificates of Analysis Clause in Contracts

Certificates of Analysis. At CLIENT’s cost and expense, XXXXXX shall test, or cause to be tested by third parties, in accordance with the Specifications, each Batch of Drug Product Produced pursuant to this Agreement before delivery to CLIENT. A certificate of analysis for each Batch delivered shall set forth the items tested, Specifications, and test results. XXXXXX shall also indicate on the final page of the Executed Batch Record that all batch Production and control records have been reviewed and approved by the appropriate quality control unit. XXXXXX shall send, or cause to be sent, such certificates to CLIENT prior to the shipment of Drug Product (unless Drug Product is shipped under quarantine). CLIENT shall test, or cause to be tested, for final release, each Batch of Drug Product as meeting the Specifications. As required by the FDA (see Section 5.2 below), CLIENT assumes full responsibility for final release of each Batch of Drug Product.

Certificates of Analysis. At CLIENT’s cost and expense, XXXXXX AXXXXX shall test, or cause to be tested by third parties, in accordance with the Specifications, each Batch of Drug Product Produced pursuant to this Agreement before delivery to CLIENT. A certificate of analysis for each Batch delivered shall set forth the items tested, Specifications, and test results. XXXXXX AXXXXX shall also indicate on the final page of the Executed Batch Record that all batch Production and control records have been reviewed and approved by the appropriate quality control unit. XXXXXX AXXXXX shall send, or cause to be sent, such certificates to CLIENT prior to the shipment of Drug Product (unless Drug Product is shipped under quarantine). CLIENT shall test, or cause to be tested, for final release, each Batch of Drug Product as meeting the Specifications. As required by the FDA (see Section 5.2 below), CLIENT assumes full responsibility for final release of each Batch of Drug Product.