Common use of Certificates of Analysis Clause in Contracts

Certificates of Analysis. BIONICHE shall perform, or cause to be performed, certain tests requested by CUMBERLAND in writing and as indicated in the Specifications on each batch of the Drug Product manufactured pursuant to this Agreement before delivery to CUMBERLAND. A certificate of analysis for each batch delivered shall be delivered with each batch and shall set forth the items tested, specifications, and test results. BIONICHE shall also indicate on the certificate of analysis that all batch production and control records have been reviewed and approved by the appropriate quality control unit. Subject to Pxxxxxxxx 0.0, XXXXXXXXXX shall test, or cause to be tested, prior to final release, each batch of the Drug Product as meeting the Specifications. As required by the FDA (see Paragraph 5.2 below), CUMBERLAND shall assume full responsibility for final release of each lot of the Drug Product.

Appears in 3 contracts

Samples: Technical Agreement (Cumberland Pharmaceuticals Inc), Technical Agreement (Cumberland Pharmaceuticals Inc), Manufacturing and Supply Agreement (Cumberland Pharmaceuticals Inc)

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Certificates of Analysis. BIONICHE XXXX shall performtest, or cause to be performedtested, certain tests requested by CUMBERLAND in writing and as indicated in accordance with the Specifications on Specifications, each batch of the Drug Product manufactured pursuant to this Agreement before delivery to CUMBERLANDCLIENT. A certificate of analysis for each batch delivered shall be delivered with each batch and shall set forth the items tested, specifications, and test results. BIONICHE XXXX shall also indicate on the certificate of analysis that all batch production and control records have been reviewed and approved by the appropriate quality control unit. Subject XXXX shall send, or cause to Pxxxxxxxx 0.0be sent, XXXXXXXXXX such certificates to CLIENT prior to the shipment of the Drug Product. CLIENT shall test, or cause to be tested, prior to for final release, each batch of the Drug Product as meeting the Specifications. As required by the FDA (see Paragraph 5.2 below), CUMBERLAND CLIENT shall assume full responsibility for final release of each lot of the Drug Product.

Appears in 1 contract

Samples: Agreement (Discovery Laboratories Inc)

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