definiens: means all federal, state, local, national and regional statutes, laws, rules, regulations and directives applicable to a particular activity hereunder, includingperformance of clinical trials, medical treatment and the processing and protection of personaland medical data, that may be in effect from time to time, including those promulgated by theUnited States Food and Drug Administration ( ), national regulatory authorities, theEuropean Medicines Agency ( ) and any successor agency to the FDA or EMA or anyagency or authority performing some or all of the functions of the FDA or EMA in any jurisdictionoutside the United States or the European Union ( each a andcollectively, ), and including cGMP and GCP ( each as defined below);all data protection requirements such as those specified in the EU Data Protection Directive andthe regulations issued under the United States Health Insurance Portability and AccountabilityAct of 1996 ( ) ; export control and economic sanctions regulations which prohibit theshipment of United States - origin products and technology to certain restricted countries, entitiesand individuals ; anti - bribery and anti - corruption laws including those pertaining to interactionswith government agents, officials and representatives ; laws and regulations governing paymentsto, and the reporting of payments made to, healthcare providers ; and any United States or othercountry ’s or jurisdiction ’s successor or replacement statutes, laws, rules, regulations anddirectives relating to the foregoing