definiens: means, with respect to an NDA, MAA or JNDA filed for a Product, ( a ) in the United States, the receipt of written notice from the FDA in accordanc e with 21 C.F.R. § 314.101(a)(2 ) that such NDA is of ficially ( b ) in the European Union, receipt of written no tice of acceptance by the EMA of such MAA for filin g under the centralized European procedure in accorda nce with any feedback received from European Regula tory Authorities ; provided that if the centralized filing procedure is not used, t hen Acceptance will be determined upon the acceptance of such MAA by the applicable Regula tory Authority in a Major Market in the EU, ( c ) in any Major Market in Europe that is not a European Union count ry, receipt of written notice of acceptance by the applicable Regulatory Authority of such MAA for filing in such country, and ( d ) in Japan, receipt of written noti ce of acceptance of filing of such JNDA from the Koseisho ( i.e., the Japanese Ministry of Health and Welfare, or any successor agency thereto )