definiens: means any multinational, federal, state, provincial, county, local, municipal or other entity, office, commission, bureau, agency, political subdivision, instrumentality, branch, department, authority, board, court, arbitral or other tribunal, official or officer, exercising executive, judicial, legislative, police, regulatory, administrative or taxing authority or functions of any nature pertaining to government 1.27 means ( a ) ( i ) an Investigational New Drug Application, as defined in the U.S. FederalFood, Drug, and Cosmetic Act, as amended, and the regulations promulgated thereunder, that is required to be filedwith the FDA before beginning clinical testing of a product in human subjects, or any successor application orprocedure, or ( ii ) any counterpart of a CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT . THE COPY FILEDHEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST . OMISSIONS AREDESIGNATED [ * * * ] . A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THESECURITIES AND EXCHANGE COMMISSION