definiens: means all federal, state, local, national and regional statutes, laws, rules, regulationsand directives applicable to a particular activity hereunder, including performance of clinical trials, medical treatmentand the processing and protection of personal and medical data, that may be in effect from time to time, includingthose promulgated by the United States Food and Drug Administration ( ), the European Medicines Agency ( ) and any successor agency to the FDA or EMA or any agency or authority performing some or all of thefunctions of the FDA or EMA in any jurisdiction outside the United States or the European Union ( each a and collectively, ), and including without limitation cGMP and GCP ( each asdefined below ) ; all data protection requirements such as those specified in the EU Data Protection Directive and theregulations issued under the United States Health Insurance Portability and Accountability Act of 1996 ( ) ; export control and economic sanctions regulations which prohibit the shipment of United States - origin products andtechnology to certain restricted countries, entities and individuals ; anti - bribery and anti - corruption laws pertaining tointeractions with government agents, officials and representatives ; laws and regulations governing payments tohealthcare providers ; and any United States or other country ’s or jurisdiction ’s successor or replacement statutes, laws, rules, regulations and directives relating to the foregoing