definiens: means, with respect to an NDA filed for a License d Product, ( a ) in the United States, the receipt ofwritten notice from the FDA in accordance with 21 C .F.R. § 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 unde r thecentralized European procedure in accordance with a ny feedback received from European Regulatory Autho rities;provided that if the centralized filing procedure is not used, t hen Acceptance will be determined upon the acceptan ceof such NDA by the applicable Regulatory Authority in a Major Country in the EU, and ( c ) in Japan, rec eipt by [COMPANY] ofwritten notice of acceptance of filing of such JNDA from the Koseisho ( i.e., the Japanese Ministry of Health andWelfare, or any successor agency thereto )