definiens: means : ( i ) the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. § 301 et seq . ), the Public Health Service Act ( 42 U.S.C. § 201 et seq . ) and the Medical DevicesRegulation and the Medical Devices Directive ; ( ii ) all applicable federal, state, local and foreign health care related fraud and abuse, false claims, anti - kickback, self - referral and transparency Legal Requirements, including the Anti - Kickback Statute ( 42 U.S.C. § 1320a-7b(b ) ), the Civil False Claims Act ( 31 U.S.C. § 3729 et seq . ), the Exclusion Laws ( 42 U.S.C. § 1320a-7 ), the Civil MonetaryPenalties Law ( 42 U.S.C. § 1320a-7a ), the criminal False Claims Law ( 42 U.S.C. § 1320a-7b(a ) ), the Physician Payments Sunshine Act(42 U.S.C. § 1320a-7h ), the federal Stark Law ( 42 U.S.C. § 1395nn ), and all criminal Legal Requirements relating to health care fraudand abuse, including 18 U.S.C. § § 286 and 287, and the health care fraud criminal provisions under HIPAA ; ( iii ) Legal Requirementsrelating to price reporting requirements and the requirements relating to the processing of any applicable rebate, chargeback oradjustment, under applicable rules and regulations relating to the Medicaid Drug Rebate Program ( 42 U.S.C. § 1396r-8 ), any statesupplemental rebate program, and Medicare average sales price reporting ( 42 U.S.C. § 1395w-3a ) ; ( iv ) the Medicare statute ( Title XVIIIof the Social Security Act ), the Medicaid statute ( Title XIX of the Social Security ), the federal TRICARE statute ( 10 U.S.C. § 1071 etseq . ), and other Legal Requirements relating to Government Programs ; ( v ) any other applicable Legal Requirements relating to theresearch, development, design, testing, manufacturing, labeling, marketing, promotion, sale and distribution of biological products, HCT / Ps, or medical devices, or durable medical equipment ; ( vi ) Legal Requirements relating to consulting agreements, royaltyagreements, and other arrangements with healthcare professionals, physician ownership / investment interests, and continuing educationand trade shows for healthcare professionals ; and ( vii ) in each case, as amended and the regulations promulgated thereunder