(xxvi) Compliance with Health Care Laws. Except as described in the Registration Statement, the General Disclosure Package and the Prospectus, the Company is and has operated in material compliance with all applicable health care laws, rules and regulations, including, (i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.) and the Public Health Service Act (42 U.S.C. §§ 201 et seq.); (ii) applicable federal, state, local and foreign health care related fraud and abuse laws, including, the federal health care Anti-kickback Statute (42 U.S.C. §1320a-7b(b)), the civil False Claims Act (31 U.S.C. §§ 3729 et seq.), criminal false claims provisions including 42 U.S.C. §1320a-7b(a)), 18 U.S.C. §§ 286 and 287, the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), the exclusion law (42 U.S.C. §1320a-7), the civil monetary penalties law (42 U.S.C. §1320a-7a) and the U.S. Physician Payments Sunshine Act (42 U.S.C. §1320a-7h); (iii) the applicable requirements of Titles XVIII (Medicare) and Title XIX (Medicaid) of the Social Security Act; (v) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. §§ 1320d et seq., 42 U.S.C. §§ 17921 et seq.); (vi) EU Directive 93/42/EEC concerning medical devices as well as European Economic Area Member State laws governing the commercialization of the Company’s products or the conduct of clinical trials of the Company’s products and product candidates; (vii) the regulations promulgated pursuant to all such laws; and (viii) other similar local, state, federal, or foreign laws and regulations (collectively, the “Health Care Laws”). Neither the Company nor any of its officers, directors, or to the knowledge of the Company, its 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 federal health care programs as that term is defined in 42 U.S.C. §1320a-7b(f) (collectively, the “Programs”). The Company has not received notice or other correspondence of any material claim, action, suit, audit, survey, proceeding, hearing, enforcement, investigation, arbitration or other action (“Action”) from any Governmental Entity (including, but not limited to, the FDA, the European Commission or EEA Member State Competent Authorities) or third party alleging that any product, operation or activity is in material violation of any Health Care Laws, and, to the knowledge of the Company, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The Company has not received any written notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the FDA, the European Commission or EEA Member State Competent Authorities or other Governmental Entity, or any other court or arbitrator or federal, state, local or foreign governmental or regulatory authority, alleging or asserting material noncompliance with any Health Care Laws. Neither the Company nor any of its officers, directors or employees, nor, to the knowledge of the Company, any of its agents have been excluded, suspended or debarred from participation in the Programs 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 from the Programs. The Company has filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by applicable Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments thereto were complete, correct and not misleading on the date filed (or were corrected or supplemented by a subsequent submission). The Company is not a party to and the Company does not have 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 a Governmental Entity.
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