FDA Debarment Sample Clauses

FDA Debarment. To the best of its knowledge, it has not employed (and, to the best of its knowledge without further duty of inquiry, has not used a contractor or consultant that has employed) and in the future will not employ (or, to the best of its knowledge without further duty of inquiry, use any contractor or consultant that employs) any individual or entity debarred by the FDA (or subject to a similar sanction of EMA), or, to the best of its knowledge without further duty of inquiry, any individual who or entity which is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMA), in the conduct of the pre-clinical activities or clinical trials of the Product.

FDA Debarment. Manufacturer certifies that neither it nor any of its employees are debarred under section 306(a) and (b) of the Federal Food, Drug and Cosmetic Act or any similar procedure of the European Medicines agency or other applicable regulatory authority.

FDA Debarment. As a condition of your employment, you must certify that you are not under investigation by the FDA for debarment action, have not been debarred under the Generic Drug Enforcement Act of 1992 (21 U.S.C. 301 et seq.), and are not otherwise being investigated, restricted or disqualified from performing services relating to clinical trials by the FDA or any other regulatory authority or professional body in any other jurisdiction. If, during the course of your employment with Xenon, you become subject to such investigation or otherwise are restricted or disqualified, you will promptly inform Xenon’s Legal Department of such event.

FDA Debarment. As of the Effective Date, neither Inyx nor any of its employees or agents, in their capacity as such, have been disqualified or debarred by the FDA, pursuant to 21 U.S.C. §§ 335(a) or (b), or been charged with or convicted under United States law for conduct relating to the development or approval, or otherwise relating to the regulation of any Product under the Generic Drug Enforcement Act of 1992, or any other relevant law, rule, or regulation or been disbarred, disqualified, or convicted under or for any equivalent or similar applicable foreign law, rule, or regulation.

FDA Debarment. AMSINO certifies that it is not debarred under subsection 306 (a) or (b) of the FD&C Act and that it has not and will not use in any capacity the services of any person debarred under such law with respect to services to be performed under this Agreement. ▇▇▇▇▇▇ further certifies that it will immediately notify UNITED in writing if it becomes debarred under subsection 306 (a) or (b) of the FD&C Act.

FDA Debarment. SMITHS certifies that it is not debarred under subsection 306 (a) or (b) of the FD&C Act and that it has not and will not use in any capacity the services of any person debarred under such law with respect to services to be performed under this Agreement. SMITHS further certifies that it will immediately notify UNITED in writing if it becomes debarred under subsection 306 (a) or (b) of the FD&C Act.

FDA Debarment. As of the Effective Date, none of Cobalt, its Affiliates, or any of their respective employees or agents, in their capacity as such, have been disqualified or debarred by the FDA, pursuant to 21 U.S.C. Sections 335(a) or (b), or been charged with or convicted under United States law for conduct relating to the development or approval, or otherwise relating to the regulation of any Generic Product under the Generic Drug Enforcement Act of 1992, or any other relevant law, rule, or regulation or been disbarred, disqualified, or convicted under or for any equivalent or similar applicable foreign law, rule, or regulation. PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.

FDA Debarment. As of the Effective Date, none of Selamine, its Affiliates, or any of their respective employees or agents, in their capacity as such, have been disqualified or debarred by the FDA, pursuant to 21 U.S.C. Sections 335(a) or (b), or been charged with or convicted under United States law for conduct relating to the development or approval, or otherwise relating to the regulation of any [***] under the Generic Drug Enforcement Act of 1992, or any other relevant law, rule, or regulation or been disbarred, disqualified, or convicted under or for any equivalent or similar applicable foreign law, rule, or regulation.