FDA Debarment Statement Clause Samples
The FDA Debarment Statement clause serves to confirm that neither the contracting party nor its key personnel are subject to debarment by the U.S. Food and Drug Administration (FDA). In practice, this clause requires the party to affirm that it has not been prohibited from participating in FDA-regulated activities, such as manufacturing or distributing pharmaceuticals or medical devices, due to violations of federal law. Its core function is to ensure compliance with regulatory requirements and to protect the other party from legal or reputational risks associated with working with debarred entities.
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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.