definiens: means ( i ) the FDCA and the regulations promulgated thereunder, ( ii ) the PHSA, and the regulations promulgated ther eunder, ( iii ) all federal and state fraud and abuse laws, including the Federal Anti - Kickback Statute ( 42 U.S .C. § 1320a-7b(b ) ), the civil False Claims Act ( 31 U.S.C. § 3729 et seq . ), the administrative False Claims Law ( 42 U.S.C. § 1320a-7b(a ) ), the Anti - Inducement Law ( 42 U.S.C. § 1320a-7a(a)(5 ) ), the exclusion laws ( 42 U. S.C. § 1320a-7 ), and the regulations promulgated pu rsuant to such statutes, ( iv ) HIPAA, the regulations promulga ted thereunder and comparable state laws, ( v ) the C ontrolled Substances Act ( 21 U.S.C. § 801 et seq . ), ( vi ) Titl es XVIII ( 42 U.S.C. § 1395 et seq . ) and XIX ( 42 U.S .C. § 1396 et seq . ) of the Social Security Act and the regulat ions promulgated thereunder, ( vii ) FDA ’s regulation s in Title 21 of the Code of Federal Regulations, ( viii ) the Publ ic Health Regulations in Title 42 of the Code of Fe deral Regulations, ( ix ) all Applicable Laws administered by the FDA and other Governmental Authorities, incl uding those governing or relating to good laboratory prac tices, good clinical practices, recordkeeping, the manufacture, import, export, testing, development, approval, pro cessing, reporting, packaging, labeling, storage, m arketing, sale, offer for sale, distribution and use of any c ompounds or products manufactured by or on behalf o f Issuer, including adverse drug reaction reporting requireme nts, informed Consent requirements and Review Board s ( as those terms are defined by the FDA ), all applicable requirements related to clinical trials and the pr otection of human subjects, applicable regulations at 21 C.F.R