definiens: means all applicable statutes, ordinances, regulations, rules, or orders of any kind whatsoeverof any Governmental Authority, including the U.S. Food, Drug and Cosmetic Act, ( 21 U.S.C. § 301 et seq . ) ( ), Prescription Drug Marketing Act, the Generic Drug Enforcement Act of 1992 ( 21 U.S.C. § 335a et seq . ), U.S. PatentAct ( 35 U.S.C. § 1 et seq . ), Federal Civil False Claims Act ( 31 U.S.C. § 3729 et seq . ), and Anti - Kickback Statute ( 42U.S.C. § 1320a-7b et seq . ), all as amended from time to time, together with any rules, regulations, and complianceguidance promulgated thereunder