definiens: means any Law of any Governmental Entity ( includi ng 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 ( a ) the FDCA and the regulations promulgated thereu nder, ( b ) the Public Health Service Act, and the re gulations promulgated thereunder, ( c ) all federal and state f raud and abuse Laws, including the Federal Anti - Kic kback Statute, the civil False Claims Act, the administra tive False Claims Law, the Anti - Inducement Law, the exclusion Laws, and the regulations promulgated pur suant to such statutes, ( d ) the Health Insurance Po rtability and Accountability Act of 1996, the regulations pro mulgated thereunder and comparable state Laws, ( e ) the Controlled Substances Act, ( f ) Titles XVIII and XIX of the Social Security Act and the regulations pro mulgated thereunder, as amended, ( 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 clause ( a ) through ( h ) as may be amended from time to time, and to the extent eac h of clause ( a ) through ( h ) applies to the safety, efficacy and quality of medicines or pharmaceuticals by regulat ing the research, development, manufacturing and distributi on of these products