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.
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Related to FDA Debarment Statement

  • Settlement Statement A settlement statement setting forth the amounts paid by or on behalf of and/or credited to each of Purchaser and Seller pursuant to this Agreement;

  • CERTIFICATION REGARDING DEBARMENT, SUSPENSION, INELIGIBILITY AND VOLUNTARY EXCLUSION

  • DEBARMENT CERTIFICATIONS The parties are prohibited from making any award at any tier to any party that is debarred or suspended or otherwise excluded from or ineligible for participation in Federal Assistance Programs under Executive Order 12549, “Debarment and Suspension.” By executing this agreement, the Engineer certifies that it is not currently debarred, suspended, or otherwise excluded from or ineligible for participation in Federal Assistance Programs under Executive Order 12549. The parties to this contract shall require any party to a subcontract or purchase order awarded under this contract to certify its eligibility to receive Federal funds and, when requested by the State, to furnish a copy of the certification.

  • Preliminary Settlement Statement Not less than five Business Days prior to the Closing, EXCO shall prepare and submit to BG for review, using the best information available to EXCO, a draft settlement statement (the “Preliminary Settlement Statement”) that shall set forth the Adjusted Closing Cash Consideration, reflecting each adjustment made in accordance with this Agreement as of the date of preparation of such Preliminary Settlement Statement and the calculation of the adjustments used to determine such amount, together with the designation of EXCO’s accounts for the wire transfers of funds as set forth in Section 9.3(c). Within three Business Days of receipt of the Preliminary Settlement Statement, BG will deliver to EXCO a written report containing all changes with the explanation therefor that BG proposes to be made to the Preliminary Settlement Statement, or if BG does not deliver such a written report, BG shall be deemed to have accepted such Preliminary Settlement Statement. During such 3 Business Day period, EXCO shall provide to BG any supporting documentation or information relating to the Preliminary Settlement Statement reasonably requested by BG as soon as reasonably practicable. The Preliminary Settlement Statement, as agreed upon by the Parties, will be used to adjust the Closing Cash Consideration at Closing, without limitation to BG’s right to challenge any adjustments to the Closing Cash Consideration as provided in Sections 3.6 through 3.8 below. If the Parties cannot agree on the Preliminary Settlement Statement prior to the Closing, the Preliminary Settlement Statement as presented by EXCO will be used to adjust the Closing Cash Consideration at Closing.

  • Exhibit D - Debarment Certification By signing and submitting this Contract, the Contractor is agreeing to abide by the debarment requirements as set out below.