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 these products, including Laws relating to Go od Laboratory Practices, Good Clinical Practices, inve stigational use, product marketing authorization, manufacturing facilities compliance and approval, G ood Manufacturing Practices, labeling, advertising, promotional practices, safety surveillance, record keeping and filing of required reports and their re spective counterparts promulgated by Regulatory Authorities in countries outside the United States and shall al so include, without limitation ( a ) the FDCA and the regulations promulgated thereunder, ( b ) the Public Health Serv ice Act, and the regulations promulgated thereunder, ( c ) all federal and state fraud and abuse Laws, including the Federal Anti - Kickback Statute, the civil False Claims Act, the administrative False Claims Law, the Anti - Induc ement Law, the exclusion Laws, and the regulations promul gated pursuant to such statutes, ( d ) the Health Ins urance Portability and Accountability Act of 1996, the reg ulations promulgated thereunder and comparable stat e Laws, ( e ) the Controlled Substances Act, ( f ) Titles XVIII and XIX of the Social Security Act and the regulat ions promulgated thereunder, ( g ) the Clinical Laboratori es Improvement Amendments and ( h ) all applicable La ws, rules and regulations, ordinances, judgments, decre es, orders, writs and injunctions administered by R egulatory Authorities, each of clauses ( a ) through ( h ) as may be amended from time to time