definiens: means all federal, state, local, national and reg ional statutes, laws, rules, regulations and directives applicable to a particul ar activity hereunder, including performance of cli nical trials, medical treatment and the processing and protection of personal and medical data, that may be in effec t from time to time, including those promulgated by the United States Food and Drug Administration ( ), national regulatory authorities, the European Medicines Agen cy ( ) and any successor agency to the FDA or EMA or any agency or authority performing some or all o f the functions of the FDA or EMA in any jurisdicti on outside the United States or the European Union ( each a and collectively, ), and including cGMP and GCP ( each as defined bel ow ) ; all data protection requirements such as those specified in the EU Data Protection Directive and the regulations issued under the United States Health Insurance Portability and Accountability Act of 199 6 ( ) ; export control and economic sanctions regulations which prohibit the shipment of United S tates - origin products and technology to certain res tricted countries, entities and individuals ; anti - bribery a nd anti - corruption laws pertaining to interactions with government agents, officials and representatives ; laws and reg ulations governing payments to healthcare providers ; and any United States or other country ’s or jurisdiction ’s successor or replacement statutes, laws, rules, reg ulations and directives relating to the foregoing