definiens: means ( i ) in respect of the United States of America, the FDA ’s approval of an New DrugApplication ( ) in respect of the Product, effective upon the date of the FDA ’s letter notifying the NDA holder ofsuch approval, ( ii ) in respect of any other country that is a member of the European Union, the EuropeanCommission ’s approval of a Regulatory Approval Application in respect of the Product following successfulcompletion of the European Medicines Agency ( ) centralized procedure or other successor procedure, 6 effective upon the date of the European Commission ’s Marketing Authorization Application approval letter, and ( iii ) inrespect of each other country in the world ( or in the European Union where the EMEA centralized procedure is notavailable ), the approval of the applicable Governmental Authority in such country that is necessary to permit theLicensed Product to be commercially sold in such country, effective on the date on which such approval becomeseffective