Common use of FDA Debarment Statement Clause in Contracts

FDA Debarment Statement. Agilent hereby certifies that neither Agilent nor any employee engaged by Agilent to perform services under this Agreement has been debarred under section 306 of the Federal Food, Drug and Cosmetic Act in connection with the performance of services under this Agreement or any comparable law or regulation outside of the United States. In the event that Agilent becomes aware of any such debarment, Agilent will provide Customer with written notice thereof. Agilent will request that all GMP manufacturing and testing subcontractors utilized pursuant to Section 2.4 of the Quality Agreement provide Customer with a certification that is substantially similar to the certification provided by Agilent in this Section 11.9. In the event that any such subcontractor fails to provide the certification, Customer may withdraw its approval for such subcontractor and Agilent shall cease using such subcontractor to provide services under this Agreement.

Appears in 1 contract

Sources: Clinical Manufacturing and Supply Agreement (Ophthotech Corp.)

FDA Debarment Statement. Agilent hereby certifies that neither Agilent nor any employee engaged by Agilent to perform services under this Agreement has been debarred under section 306 of the Federal Food, Drug and Cosmetic Act in connection with the performance of services under this Agreement or any comparable law or regulation outside of the United States. In the event that Agilent becomes aware of any such debarment, Agilent will provide Customer with written notice thereof. Agilent will request that all GMP manufacturing and testing subcontractors utilized pursuant to Section 2.4 of the Quality Agreement provide Customer with a certification that is substantially similar to the certification provided by Agilent in this Section 11.911.10. In the event that any such subcontractor fails to provide the certification, Customer may withdraw its approval for such subcontractor and Agilent shall cease using such subcontractor to provide services under this Agreement.

Appears in 1 contract

Sources: Commercial Manufacturing and Supply Agreement (Ophthotech Corp.)

FDA Debarment Statement. Agilent hereby certifies that neither Agilent nor any employee or subcontractor engaged by Agilent to perform services under this Agreement has been debarred under section 306 of the Federal Food, Drug and Cosmetic Act in connection with the performance of services under this Agreement or any comparable law or regulation outside of the United States. In the event that Agilent becomes aware of any such debarment, Agilent will provide Customer with written notice thereofthereof immediately. Agilent will request that all GMP cGMP manufacturing and testing subcontractors utilized pursuant to Section 2.4 5.12 of the Quality Agreement provide Customer with a certification that is substantially similar to the certification provided by Agilent in this Section 11.911.10. In the event that any such subcontractor fails to provide the certification, Customer may withdraw its approval for such subcontractor and Agilent shall cease using such subcontractor to provide services under this Agreement.

Appears in 1 contract

Sources: Commercial Manufacturing and Supply Agreement (IVERIC Bio, Inc.)