definiens: means any Law of any Governmental Entity ( including multi - country organizations ) the purpose ofwhich is to ensure the safety, efficacy and quality of medicines or pharmaceuticals by regulating the research, development, manufacturing and distribution of these products, including Laws relating to Good Laboratory Practices, Good Clinical Practices, investigational use, product marketing authorization, manufacturing facilities compliance andapproval, Good Manufacturing Practices, labeling, advertising, promotional practices, safety surveillance, recordkeeping and filing of required reports and their respective counterparts promulgated by Regulatory Authorities incountries outside the United States and shall also include, without limitation ( a ) the FDCA and the regulationspromulgated thereunder, ( b ) the Public Health Service Act, and the regulations promulgated thereunder, ( c ) all federaland state fraud and abuse Laws, including the Federal Anti - Kickback Statute, the civil False Claims Act, theadministrative False Claims Law, the Anti - Inducement Law, the exclusion Laws, and the regulations promulgatedpursuant to such statutes, ( d ) the Health Insurance Portability and Accountability Act of 1996, the regulationspromulgated thereunder and comparable state Laws, ( e ) the Controlled Substances Act, ( f ) Titles XVIII and XIX of theSocial Security Act and the 59regulations promulgated thereunder, ( g ) the Clinical Laboratories Improvement Amendments and ( h ) all applicableLaws, rules and regulations, ordinances, judgments, decrees, orders, writs and injunctions administered by RegulatoryAuthorities, each of clause ( a ) through ( h ) as may be amended from time to time, and to the extent each of clause(a ) through ( h ) applies to the safety, efficacy and quality of medicines or pharmaceuticals by regulating the research, development, manufacturing and distribution of these products