QCMD and Release Testing Sample Clauses

QCMD and Release Testing. At NUVELO’s cost and expense, BPS shall test, or cause to be tested by third parties in accordance with Section 5.2 and in accordance with the Specifications, each Batch of Drug Product Produced pursuant to this Agreement for Release before Final Release and delivery to NUVELO pursuant to Section 2.9. The QCMD shall contain the Certificate of Analysis for each Batch to be delivered, the items tested, the Specifications, and the test results. Any material change to an approved QCMD will be reviewed and approved by BPS and by NUVELO prior to the change being implemented. The Parties acknowledge that the following are examples of material changes to the QCMD: any change that is determined to be a material change to the QCMD in accordance with the Quality Agreement; and any change to a QCMD that is, involves or results in a change to any Specification. BPS shall confirm on the final page of the Released Executed Batch Record for each Batch that all Batch Production and control records have been reviewed and approved by the appropriate quality unit in accordance with the Quality Agreement. BPS shall send, or cause to be sent, the Release Documentation to NUVELO to enable NUVELO to determine whether the applicable Batch can be Finally Released and thereafter delivered to NUVELO’s carrier pursuant to Section 2.9 (unless Drug Product is shipped under quarantine at the written request of NUVELO pursuant to Section 2.9). As required by the FDA, NUVELO assumes full responsibility for Final Release of each Batch of Drug Product.