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], its Affiliate or Sublicensee of written notice of acceptance by the EMA of suchMAA for filing under the centralized European procedure in accordance with any feedback received from EuropeanRegulatory Authorities ; provided that if the centralized filing procedure is not used, then Acceptance of Filing will bedetermined upon the acceptance of such MAA by the applicable Regulatory Authority in a Major Country in the EU, and(c ) in Japan, receipt by [COMPANY], its Affiliate or Sublicensee of written notice of acceptance of filing of such JNDA fromthe Koseisho ( i.e