definiens: means all federal, state, local, national and regional statutes, laws, rules, regulations anddirectives applicable to a particular activity hereunder, including performance of clinical trials, medicaltreatment and the processing and protection of personal and medical data, that may be in effect from timeto time, including those promulgated by the United States Food and Drug Administration ( ), theEuropean Medicines Agency ( ) and any successor agency to the FDA or EMA or any agency orauthority performing some or all of the functions of the FDA or EMA in any jurisdiction outside the UnitedStates or the European Union ( each a and collectively, ), and including without limitation cGMP and GCP ( each as defined below ) ; all data protection requirementssuch as those specified in the EU Data Protection Directive and the regulations issued under the UnitedStates Health Insurance Portability and Accountability Act of 1996 ( ) ; export control and economicsanctions regulations which prohibit the shipment of United States - origin products and technology to certainrestricted countries, entities and individuals ; anti - bribery and anti - corruption laws pertaining to interactionswith 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 replacementstatutes, laws, rules, regulations and directives relating to the foregoing