FDA Laws Sample Clauses

FDA Laws. “FDA Laws” shall mean the FDCA, the Public Health Service Act, CLIA, Controlled Substances Act and, for each of the foregoing, all comparable state Legal Requirements and the rules and regulations promulgated thereunder by FDA and any other comparable Governmental Entities.
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FDA Laws. Each of Holdings and its Subsidiaries is, and at all times has been, in compliance with the FDCA and all regulations promulgated thereunder and all other applicable laws and regulations of the relevant Government Authorities in the countries in which each of Holdings and its Subsidiaries distributes or markets its products, including but not limited to (i) the requirement for and the terms of all necessary FDA Permits, including, without limitation, approvals, clearances, exemptions, and licenses, (ii) current Good Manufacturing Practices (“cGMP”), (iii) establishment registration and product listing, (iv) labeling, promotion, and advertising, (v) Good Clinical Practices (“GCP”) and Good Laboratory Practices (“GLP”), (vi) payment of all application, product and establishment fees, and (vii) recordkeeping and reporting requirements other than those applicable to cGMP, GCP, and GLP (collectively, “FDA Law or Regulation”). Without limiting the generality of the foregoing:
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FDA Laws. Principal Investigator and INSTITUTION agree to conduct the Clinical Trial and maintain records and data during and after the term of this Agreement in compliance with all applicable legal and regulatory requirements, including without limitation, any applicable requirements of the FDA.
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FDA Laws. Each Covered Person shall comply with all requirements of all FDA Laws applicable to such Covered Person.
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FDA Laws. Each of Holdings and its Subsidiaries is, and at all times has been, in compliance with the FDCA and all regulations promulgated thereunder and all other applicable laws and regulations of the relevant Government Authorities in the countries in which each of Holdings and its Subsidiaries distributes or markets its products, including but not limited to (i) the requirement for and the terms of all necessary FDA Permits, including, without limitation, approvals, clearances, exemptions, and licenses, (ii) current Good Manufacturing Practices (“cGMP”), (iii) establishment registration and product listing, (iv) labeling, promotion, and advertising, (v) Good Clinical Practices (“GCP”) and Good Laboratory Practices (“GLP”), (vi) payment of all application, product and establishment fees, and (vii) recordkeeping and reporting requirements other than those applicable to cGMP, GCP, and GLP (collectively, “FDA Law or Regulation”). Without limiting the generality of the foregoing: (a) Each of Holdings and its Subsidiaries holds all material registrations, clearances, approvals, licenses, authorizations, or permits required by or issued under the FDCA (“FDA Permits”), and has made all declarations, submissions, filings, and listings that are necessary to conduct its business and comply with FDA Law or Regulation. Each of Holdings’ and its Subsidiaries’ FDA Permits is in effect or where the failure to have such FDA Permits or make such declarations and filings could not reasonably be expected to have a Material Adverse Effect. A list of all FDA Permits is in full force and effect in all material respects and, to the knowledge of each Credit Party, no suspension, revocation, cancellation or withdrawal of such FDA Permit is threatened and there is no basis for believing that such FDA Permit will not be
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Related to FDA Laws

  • Health Care Laws The Company has operated and currently is in compliance in all material respects with all applicable Health Care Laws (defined herein), including, without limitation, the rules and regulations of the FDA, the U.S. Department of Health and Human Services Office of Inspector General, the Centers for Medicare & Medicaid Services, the Office for Civil Rights, the Department of Justice or any other governmental agency or body having jurisdiction over the Company or any of its properties, and has not engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other state or federal health care program. For purposes of this Agreement, “Health Care Laws” shall mean the federal Anti-kickback Statute (42 U.S.C. § 1320a-7b(b)), the Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the civil False Claims Act (31 U.S.C. §§ 3729 et seq.), the criminal False Claims Act (42 U.S.C. § 1320a-7b(a)), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. § 1320d et seq.) (“HIPAA”), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. §§ 17921 et seq.), the patient privacy, data security and breach notification provisions under HIPAA, the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.), Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), the regulations promulgated pursuant to such laws, and any other similar local, state or federal law and regulations. The Company has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence, communication or notice from the FDA or any other governmental or regulatory authority alleging or asserting noncompliance with any Health Care Laws applicable to the Company. The Company is not a party to nor has any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any governmental or regulatory authority. Neither the Company nor any of its employees, officers, directors or, to the Company’s Knowledge, consultants has been excluded, suspended or debarred from participation in any U.S. state or federal health care program or human clinical research or, to the Company’s Knowledge, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

  • Applicable Laws The Contractor agrees to conduct all activities under this Agreement in accordance with all applicable rules, regulations, directives, standards, ordinances, and laws, in effect or promulgated during the term of this Agreement, including without limitation, workers’ compensation laws, minimum and maximum salary and wage statutes and regulations, and licensing laws and regulations. When required, the Contractor shall furnish H-GAC with satisfactory proof of its compliance therewith.

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