definiens: means any Law of any Governmental Ent ity ( including multi - country organizations ) the purpose of which is to ensure the safety, efficacy and quality of medicines or pharmaceuticals by regu lating the research, development, manufacturing and distributi on of 75 these products, including Laws relating to Good Lab oratory Practices, Good Clinical Practices, investi gational use, product marketing authorization, manufacturing facilities compliance and approval, Good Manufactu ring Practices, labeling, advertising, promotional pract ices, safety surveillance, record keeping and filin g of required reports and their respective counterparts promulgat ed by Regulatory Authorities in countries outside t he United States and shall also include, without limitation ( a ) the FDCA and the regulations promulgated thereun der, ( b ) the Public Health Service Act, and the regulati ons promulgated thereunder, ( c ) all federal and sta te fraud and abuse Laws, including the Federal Anti - Kickback Sta tute, the civil False Claims Act, the administrativ e False Claims Law, the Anti - Inducement Law, the exclusion Laws, and the regulations promulgated pursuant to s uch statutes, ( d ) the Health Insurance Portability and Accountability Act of 1996, the regulations promulg ated thereunder and comparable state Laws, ( e ) the Contr olled Substances Act, ( f ) Titles XVIII and XIX of t he Social Security Act and the regulations promulgated thereu nder, ( g ) the Clinical Laboratories Improvement Amendments and ( h ) all applicable Laws, rules and r egulations, ordinances, judgments, decrees, orders, writs and injunctions administered by Regulatory Authorit ies, each of clauses ( a ) through ( h ) as may be amen ded from time to time