definiens: means any court, tribunal, arbitrator, agency, commission, official or other instrumentality of any country, federal, state, county, city or other politicalsubdivision, foreign or domestic, including without limitation the FDA, the SEC, the United KingdomFinancial Conduct Authority, the London Stock Exchange plc, the AIM Market of the London StockExchange plc, the NASDAQ Stock Market LLC and any other governmental or regulatoryinstrumentality with responsibility for granting any licenses, registrations or regulatory approvals . means any Law the purpose of which is to ensure the safety, efficacy andquality of medicines by regulating the research, development, manufacturing, commercialization anddistribution of these products, including Laws relating to good laboratory practices, good clinicalpractices, investigational use, product marketing authorization, manufacturing compliance andapproval, good manufacturing practices, labeling, advertising, privacy, promotional practices, pricing, safety surveillance, record keeping and filing of required reports, including the FDA Act, theComprehensive Drug Abuse Prevention and Control Act of 1970, the Controlled Substances Act, thePatient Protection and Affordable Care Act, the Health Insurance Portability and Accountability Act of1996, the Public Health Service Act, as amended, and applicable regulations issued by aGovernmental or Regulatory Authority