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 without limitation cGMP and GCP ( each as defined below ) ; all data protection requirements such as those specified in the EU Gene ral Data Protection Regulation 2016/679 and the reg ulations issued under the United States Health Insurance Por tability and Accountability Act of 1996 ( ) ; export control and economic sanctions regulations which pr ohibit the shipment of United States - origin product s and technology to certain restricted countries, entitie s and individuals ; anti - bribery and anti - corruption laws pertaining to interactions with government agents, officials a nd representatives ; laws and regulations governing payments to healthcare providers ; and any United States or othe r country ’s or jurisdiction ’s successor or replacem ent statutes, laws, rules, regulations and directives relating to the foregoing