definiens: shall mean all Laws relating to the development, manufacture, production, assembly, processing, pricing, marketing, promotion, sale, or distribution, coverage or reimbursement of a device, including(i ) the Federal Health Care Program Anti - Kickback Statute, 42 U.S.C. § 1320a- 7b(b ) ; the Federal civil False Claims Act, 31 U.S.C. § § 3729 - 3733 ; the criminal provisions under HIPAA ; the Program Fraud Civil Remedies Act, 31 U.S.C. § § 3801 - 3812 ; the criminal False Claims Law,42 U.S.C. § § 1320a-7b(a ), the Civil Monetary Penalties Law, 42 U.S.C. § 1320a-7a ; the exclusion authorities, 42 U.S.C. § 1320a-7 ; thePhysician Payment Sunshine Act, 42 U.S.C. § 1320a-7h ; Medicare and Medicaid coverage and reimbursement provisions ( Titles XVIII andXIX of the Social Security Act ) ; and the applicable requirements of Medicare, Medicaid and other health care programs of otherGovernmental Authorities, including the Veterans Health Administration and U.S. Department of Defense health care and contractingprograms, each as amended, and any regulations promulgated thereunder ; and ( ii ) any applicable comparable foreign, local, state or federalhealth care Laws, including § § 299, 299a / b and 331 et seq . of the German Criminal Code ( Strafgesetzbuch ), the German Act on Advertisingin the Health Care Sector ( Heilmittelwerbegesetz ), the German Act against Unfair Competition ( Gesetz gegen den unlauteren Wettbewerb),and § 128 of the German Social Code V ( Sozialgesetzbuch V ), each as amended, and the applicable regulations promulgated thereunder