definiens: means all applicable statutes, ordinances, regula tions, directives, rules, or orders of any kind whatsoever of any Governmental Authority appli cable to any activity hereunder, including the EU D ata Protection Directive and the regulations issued und er the U.S. Health Insurance Portability and Accoun tability Act of 1996 ( ), the U.S. Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. § 301 et seq . ) ( ), the Prescription Drug Marketing Act of 1987 ( 21 U.S.C. § § 331, 333, 353, 381 ), the Generic Drug Enforcement Act of 1992 ( 21 U.S.C. § 335(a ) et seq . ), U.S. Patent Ac t ( 35 U.S.C. § 1 et seq . ), the Federal False Claims Act ( 31 U.S.C. § 3729 et seq . ), and the Anti - Kickback Statut e ( 42 U.S.C. § 1320a-7b et seq . ), and the Foreign Co rrupt Practices Act of 1977 ( 15 U.S.C. § § 78dd-1, et seq . ), all as amended from time to time, together with any rules, regulations, and guidance documents, and regulatory standards ( including GCP, GLP, and GMP ) promulgate d relating to any of the foregoing, all as amended fr om time to time