that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were
corrected or supplemented by a subsequent submission).
(xxxvii) Compliance with Health Care Laws. For
the past six (6) years, the Company has operated and currently is in compliance with all applicable health care laws, rules and regulations (except where such failure to operate or non-compliance would
not, singly or in the aggregate, have a material adverse effect on the Company and its subsidiaries, taken as a whole), including, without limitation and in each case to the extent applicable, (i) the Federal, Food, Drug and Cosmetic Act (21
U.S.C. §§ 301 et seq.); (ii) all federal, state, local and foreign healthcare related fraud and abuse laws, including, without limitation, the federal Anti-kickback Statute (42 U.S.C. §
1320a-7b(b)), the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil False Claims Act (31 U.S.C. §§ 3729 et seq.), the criminal False
Claims Law (42 U.S.C. § 1320a-7b(a)), all criminal laws relating to healthcare fraud and abuse, including but not limited to, 18 U.S.C. §§ 286 and 287, the healthcare fraud criminal provisions
under the U.S. Health Insurance Portability and Accountability Act of 1996 (HIPAA) (42 U.S.C. §§ 1320d et seq.), the exclusions law (42 U.S.C. § 1320a-7), and the civil
monetary penalties law (42 U.S.C. § 1320a-7a); (iii) HIPAA, as amended by the Health Information Technology for Economic Clinical Health Act (42 U.S.C. Section 17921 et seq.); (iv) the regulations
promulgated pursuant to such laws; and (v) any other similar local, state, federal, or foreign laws including French laws (collectively, the Health Care Laws). For the past six (6) years, neither the Company, nor
to the Companys knowledge, any of its officers, directors, employees or agents have 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 healthcare program. The Company has not received written notice or to the Companys knowledge other correspondence of any claim, action, suit, audit, survey, proceeding, hearing, enforcement,
investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Health Care Laws, and, to the
Companys knowledge, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The Company is not a party and does not have any material ongoing reporting obligations pursuant to
any corporate integrity agreement, deferred prosecution agreement, monitoring agreement, consent decree, settlement order, plan of correction or similar agreement imposed by any governmental or regulatory authority. Additionally, neither the
Company, nor to the Companys knowledge, any of its employees, officers or directors, 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 knowledge
of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.
(xxxviii) Clinical Trials. The studies, tests and preclinical and clinical trials (collectively,
studies) conducted by or, to the Companys knowledge, on behalf of, the Company were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and
controls pursuant to accepted
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