definiens: means with respect to an NDA or MAA filed for a Product, ( a ) in the United States, the receipt by [COMPANY] orits Affiliate or Sublicensee of written notice from the FDA in accordance with 21 CFR 314.101(a)(2 ) that such NDA isofficially, ( b ) in the European Union, receipt by [COMPANY] or its Affiliate or Sublicensee of written notice ofacceptance by the EMEA of such MAA for filing under the centralized European procedure in accordance with anyfeedback received from European Regulatory Authorities ; provided, that if the centralized filing procedure is not used, then Acceptance shall be determined upon the acceptance of such MAA by the applicable Regulatory Authority in thefirst Major EU Country, ( c ) in Japan, receipt by [COMPANY] or its Affiliate or Sublicensee of written notice of acceptance offiling of such MAA from the MHLW and ( d ) in any Other Major Market Country after receipt by [COMPANY] or its Affiliate orSublicensee of written notice of acceptance of filing of the applicable applications by the competent RegulatoryAuthority of that specific country