definiens: means, with respect to an NDA filed for a Licensed Product, ( a ) in the United States, the receipt ofwritten notice from the FDA in accordance with 21 CFR 314.101(a)(2 ) that such NDA is officially, ( b ) in theEuropean Union, receipt by [COMPANY] of written notice of acceptance by the EMEA of such NDA for filing under thecentralized European procedure in accordance with any feedback received from European Regulatory Authorities;provided, that if the centralized filing procedure is not used, then Acceptance shall be determined upon the acceptance ofsuch NDA by the applicable Regulatory Authority in a 2***Confidential Treatment RequestedMajor Country in the EU, and ( c ) in Japan, receipt by [COMPANY] of written notice of acceptance of filing of such NDA from theJapanese Ministry of Health, Labour and Welfare ( )