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 by [COMPANY] of written notice of acceptance by the EMA of such MAA for filing under the centralized European procedure in accordance with any feedback received from Euro pean Regulatory Authorities ; provided that if the centralized filing procedure is not use d, then Acceptance will be determined upon the acceptance of such MAA by the a pplicable Regulatory Authority in a Major Market in the EU, ( c ) in any Major Market in Europe that is not a European Union country, receipt by [COMPANY] of writt en notice of acceptance by the applicable Regulatory Authorit y of such MAA for filing in such country, and ( d ) i n Japan, receipt by [COMPANY] of written notice of acceptance o f filing of such JNDA from the Koseisho ( i.e., the Japanese Ministry of Health and Welfare, or any successor ag ency thereto )