definiens: means all ( a ) federal, state, local, national and regional statutes, laws, rules, regulations and directives applicable to a particular activity under this Agreement ( including the performance of clinicaltrials and medical treatment ) that may be in effect from time to time ( including GCP, GDP, GLP, GMP and otherspromulgated by Regulatory Authorities ) ; ( b ) applicable data protection and patient privacy laws and requirements in allcountries in which information or data that is protected by any applicable privacy laws is received, observed, collectedor otherwise possessed ( including HIPAA ( defined below ) in the United States, the European Union Privacy Directive(Directive 95/46 / EC ), the Personal Information Protection and Electronic Documents Canada ( PIPEDA ) in Canada, and any related regulations ) ; ( c ) export control and economic sanctions regulations that prohibit the shipment ofUnited States - origin products and technology to certain restricted countries, entities and individuals ; ( d ) anti - briberyand anti - corruption laws pertaining to interactions with government agents, officials and representatives ( including theUnited States Foreign Corrupt Practices Act ) ; ( e ) laws and regulations governing payments to healthcare providers;(f ) laws and requirements governing ineligibility to participate in federal, state or other healthcare programs ( includingdebarment under 21 USC § 335a, disqualification under 21 CFR § 312.70 or § 812.119, sanctions by a Federal HealthCare Program ( as defined in 42 USC § 1320a-7b(f ) ), including the federal Medicare or a state Medicaid program ) ; and(g ) successor or replacement statutes, laws, rules, regulations and directives relating to the foregoing