definiens: means all laws, statutes, rules, regulations, ordinances, guidelines and other pronouncements having theeﬀect of law of any federal, national, multinational, state, provincial, county, city or other political subdivision and orders of anykind whatsoever of any Governmental Authority, including cGCP, cGLP, cGMP, FFDCA, the U.S. Public Health Service Act, Prescription Drug Marketing Act, the Generic Drug Enforcement Act of 1992 ( 21 U.S.C. § 335a et seq . ), U.S. Patent Act ( 35U.S.C. § 1 et seq . ), Federal Civil False Claims Act ( 31 U.S.C. § 3729 et seq . ), and Anti - Kickback Statute ( 42 U.S.C. § 1320a-7bet seq . ), all as amended from time to time, together with any rules, regulations, and compliance guidance promulgatedthereunder