Debarment/Exclusion. Executive hereby certifies to the Company that, as provided in Section 306(a) and Section 306(b) of the U.S. Federal Food, Drug and Cosmetic Act (21 U.S.C. § 335a(a) and 335a(b)) and/or under any equivalent law within or outside the United States, he/she has not in the past been and/or is not currently (or threatened to be or subject to any pending action, suit, claim investigation or administrative proceeding which could result in him/her being) (i) debarred or (ii) excluded from participation in any federally funded healthcare program or (iii) otherwise subject to any governmental sanction in any jurisdiction (including disqualification from participation in clinical research) that would affect or has affected Executive’s ability to perform his/her obligations under this Agreement or his/her employment or prevent him/her from working for the Company in any capacity in any jurisdiction. Executive hereby confirms that he/she is not on any of the following exclusion lists: (a) Food and Drug Administration Debarment List; (b) General Services Administration Excluded Parties List System; or (c) Office of Inspector General List of Excluded Individuals/Entities. Executive warrants and represents to the Company that he/she will notify the Company immediately if any of the foregoing occurs or is threatened and that the obligation to provide such notice will remain in effect following the termination of his/her employment with the Company for any reason, voluntary or involuntary. Any violation of this section by Executive may result in the termination of his/her employment with the Company. Immediately upon the request of the Company at any time, Executive will certify to the Company in writing his/her compliance with the provisions of this section.
Debarment/Exclusion. Each Party represents and warrants that neither it nor any of its employees or representatives has been or is debarred pursuant to the FDCA or has been or is excluded from participating in a federal health care program, including without limitation the Medicare and Medicaid programs. Moreover, each Party covenants that in the event it or any of its employees or representatives is subsequently debarred under the FDCA or excluded from a federal health care program during the term hereof, it shall notify the other, within five (5) business days.
Debarment/Exclusion. Consultant represents and warrants that neither Consultant, nor any person or entity authorized to assist Consultant in the performance of the Consulting Services has ever been and is not currently debarred, suspended, or excluded from, proposed for debarment, suspension, or exclusion from, or otherwise ineligible for the award of contracts by any federal agency or participation in any federal health care program. Consultant’s representation and warranty hereunder includes, but is not limited to, debarment under Section 306(a) or (b) of the federal Food, Drug, and Cosmetic Act, exclusion from participation in any federal health care program (as defined in 42 U.S.C. § 1320a–7b(f)) under 42 U.S.C. § 1320a-7(a) or (b), or exclusion by any federal government agency from receiving federal contracts or federally approved subcontracts under the Federal Acquisition Regulations (FAR) or supplements thereto.
Debarment/Exclusion. Licensure and Response. Zákaz činnosti, vyloučení, udělení oprávnění a odezva. Health Service Provider certifies that it is not debarred or restricted from conducting clinical research and shall not use in any capacity the services of any person debarred or restricted from conducting clinical research under Applicable Law with respect to services to be performed under this Agreement. Health Service Provider also certifies that it is not excluded from any governmental health care program. Health Service Provider further certifies that it is not, due to its own misconduct, subject to a government mandated corporate integrity agreement and has not violated any applicable anti-kickback or false claims laws or regulations. During the term of this Agreement and for three (3) years after its termination, Health Service Provider shall notify Sponsor promptly in writing [to the extent possible, within two (2) business days] if either of these certifications needs to be amended in light of new information or if Health Service Provider becomes aware of any material issues related to the medical licensure of any associated Trial researchers (including the PI). Health Service Provider shall cooperate with Sponsor regarding any responsive action necessary, i.e. shall update and specify such certifications as neccessary. Poskytovatel zdravotních služeb potvrzuje, že mu nebyla zakázána činnost ani nebylo omezeno provádění klinického výzkumu ani nebude využívat v jakémkoli rozsahu služeb jakékoli osoby, jíž byla zakázána činnost nebo která byla omezena v provádění klinického výzkumu podle platných zákonů s ohledem na služby, které mají být podle této smlouvy poskytovány. Poskytovatel zdravotních služeb rovněž stvrzuje, že není z důvodů vlastního pochybení vyloučen z žádného státního programu zdravotní péče. Poskytovatel zdravotních služeb dále stvrzuje, že nepodléhá státem nařízené smlouvě o korporátní integritě a neporušil žádné platné protikorupční zákony nebo zákony o nepravdivých tvrzeních. Během doby platnosti této smlouvy a tři (3) roky po jejím ukončení bude poskytovatel zdravotních služeb okamžitě písemně informovat zadavatele [je-li to možné, pak do dvou (2) pracovních dnů], jestliže bude nutno kterékoli z těchto prohlášení doplnit ve světle nových informací či jestliže se poskytovatel zdravotních služeb dozví o jakýchkoli podstatných otázkách týkajících se udělení oprávnění u kteréhokoli ze zapojených výzkumných pracovníků hodnocení (včetně hlavního zkoušejícího)...
Debarment/Exclusion. Institution and Investigator each certify that it/she/he is not debarred by any regulatory authority or restricted from conducting clinical research under Applicable Law and will not use in any capacity the services of any person debarred by any regulatory authority or restricted from conducting clinical research under Applicable Law in connection with the conduct of the Trial. 16. Z ákaz činnosti/vyloučení z účasti na k linických hodnoceních. Poskytovatel zdravotních služeb a zkoušející každý jednotlivě xxxxxxxxxx, xx xxxxxx xx xxxxxxxx xxxxx xxxxx činnosti ani zákaz účasti na klinickém výzkumu na základě ustanovení platných zákonů a zavazují se v souvislosti s prováděním klinického hodnocení nevyužívat služby žádné osoby, o které se dozví, že má státními orgány zakázanou činnost nebo účast na provádění klinických hodnocení xx xxxxxxx xxxxxxxxxx xxxxxxxx xxxxxx.
Debarment/Exclusion. Institution and Investigator each certify that neither it/she/he nor any Trial Staff (a) is debarred by any regulatory authority or restricted from conducting clinical research under Applicable Law; or (b) will use in any capacity the services of any person debarred by any regulatory authority or restricted from conducting clinical research under 16. Vyloučení/vyřazení. Zdravotnické zařízení a zkoušející potvrzují, že ani oni, ani personál klinického hodnocení (a) nejsou žádným regulačním úřadem vyloučeni nebo jinak omezeni v provádění klinického výzkumu podle příslušných právních předpisů; ani (b) nebudou v souvislosti s prováděním klinického hodnocení v jakékoli funkci využívat služeb osoby, které
Debarment/Exclusion. Institution and Investigator each certify that it/she/he is not debarred by any regulatory authority or restricted from conducting clinical research under Applicable Law and will not use in any capacity the services of any person debarred by any regulatory authority or restricted from conducting clinical research under Applicable Law in connection with the conduct of the Trial. 16. Zákaz činnosti/vyloučení z účasti na klinických hodnoceních. Poskytovatel a zkoušející každý jednotlivě prohlašují, že nemají od státních úřadů zákaz činnosti ani zákaz účasti na klinickém výzkumu na základě ustanovení platných zákonů a zavazují se v souvislosti s prováděním klinického hodnocení nevyužívat služby žádné osoby, která má státními orgány zakázanou činnost nebo účast na provádění klinických hodnocení na základě ustanovení platných zákonů.
Debarment/Exclusion. Each party hereby represents and warrants to the other Party that neither it nor any of its employees, contractors or agents are, and at no time have been and, will not at any time during the Term of this Agreement be: (i) sanctioned within the meaning of Social Security Act Section 1128A or any amendments thereof; (ii) convicted of violating the federal Sxxxx law, federal False Claims Act, federal Anti-Kickback Statute, HIPAA provisions, federal Civil Money Penalties statute, or similar state laws, or (iii) debarred, excluded or suspended from participation in any federally funded healthcare program, including, but not limited to, Medicare and Medicaid (“Federal Program”). Each Party hereby agrees to immediately notify the other Party of any threatened, proposed, or actual exclusion of the notifying Party from any Federal Program. In the event that a Party is excluded from participating in any Federal Program during the Term of this Agreement, or if at any time during the Term of this Agreement it is determined that a Party is in breach of this provision, this Agreement shall automatically terminate as of the date of such exclusion or breach.
Debarment/Exclusion. Biovest represents and warrants that Biovest has not been debarred pursuant to the Federal Food, Drug and Cosmetic Act (the “Act”) or excluded from any Federal Health Care Program, including but not limited to, Medicare or Medicaid (each a “Federal Health Care Program”) or the General Services Administration. In addition, Biovest agrees to notify AYTU immediately if Biovest is debarred under the Federal Food Drug and Cosmetic Act or excluded under a Federal Health Care Program or from the General Services Administration during the term of the Agreement. Biovest understands that such debarment or exclusion may result in the immediate termination of the Agreement.
Debarment/Exclusion. To the knowledge of the Sellers, no officer, director, employee, agent or contractor of the Sellers or Subsidiaries, have been debarred or been convicted of any crime or engaged in any conduct for which debarment is mandated or permitted by 21 U.S.C. § 335a or disqualification as a clinical investigator under 21 C.F.R. § 312.70 or 21 C.F.R. § 812.119 or any similar Legal Requirements, and neither the Seller a Subsidiary nor any of its respective officers, directors, employees, agents, and contractors has engaged in any conduct that would reasonably be expected to result in debarment or disqualification as an investigator. To the knowledge of the Sellers, no officer, employee or agent of the Sellers or Subsidiaries has been convicted of any crime or engaged in any conduct for which such person or entity could be excluded from participating in the federal health care programs under Section 1128 of the Social Security Act or any similar law or regulation.
