definiens: means, with respect to an NDA, MAA or JNDA filed for a Product, ( a ) in the United States, the receiptof written 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 EMA of such MAA 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 will be determined upon the acceptanceof such MAA by the applicable Regulatory Authority in a Major Market in the EU, ( c ) in any Major Market in Europethat is not a European Union country, receipt by [COMPANY] of written notice of acceptance by the applicable RegulatoryAuthority of such MAA for filing in such country, and ( d ) in Japan, receipt by [COMPANY] of written notice of acceptance offiling of such JNDA from the Koseisho ( i.e