definiens: means, with respect to a Drug Approval Application filed for a Product, ( a ) in the UnitedStates, the receipt of written notice from the FDA in accordance with 21 CFR 314.101(a)(2 ) that such Drug ApprovalApplication is officially, ( b ) in the European Union, receipt by [COMPANY] of written notice of acceptance by the EMEA ofsuch Drug Approval Application for filing under the centralized European procedure in accordance with any feedbackreceived from European Regulatory Authorities ; provided, that if the centralized filing procedure is not used, then Acceptanceshall be determined upon the acceptance of such Drug Approval Application by the applicable Regulatory Authority in aMajor European Country, and ( c ) in Japan, receipt by [COMPANY] of written notice of acceptance of filing of such Drug ApprovalApplication from the Japanese Ministry of Health, Labour and Welfare ( )