definiens: shall mean all federal, state and local laws and regulations that apply to this Agreement including, without limitation, ( i ) the Bayh - Dole Act ( ii ) the 2 Federal Food, Dmg, and Cosmetic Act ( 21 U.S.C § 321 et seq . ) ( iii ) the federal Anti­kickback Statute ( 42 U.S.C. § 1320a-7b(b ) ) ( iv ) the Stark Law ( 42 U.S.C. § 1395nn ) ( v ) the Anti - Inducement Law ( 42 U.S.c . § 1320a-7a(a)(5 ) ) ( vi ) the civil False Claims Act ( 31 U.S.C. § § 3729 et seq . ) ( vii ) the administrative False Claims Law ( 42 U.S.C. § 1320a-7b(a ) ) ( viii ) the Health Insurance Portability and Accountability Act of 1996 ( 42 U.S.C. § 1320d et seq . ), ( ix ) the exclusion laws ( x ) SSA § 1128 ( 42 U.S.C. § 1320a-7 ) ( xi ) Medicare ( Title XVIII of the Social Security Act ), ( xii ) Medicaid ( Title XIX of the Social Security Act ) ; ( xiii ) the Clinical Laboratory Improvements Act of 1988 ( CLIA ) ; and ( xiv ) data security, protection and privacy laws in the applicable jurisdictions