definiens: means, with respect to an NDA filed for SPC-3649 or an SPC-3649 Product, ( a ) in the United States, t hereceipt by [COMPANY], its Affiliates or Sublicensees of w ritten notice from the FDA in accordance with 21 CF R 314.101(a)(2 ) thatsuch NDA is officially, ( b ) in the European Union, receipt by [COMPANY] of written notice of accepta nce by the EMEA ofsuch NDA 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 u sed, then Acceptance shall be determinedupon the acceptance of such NDA by the applicable R egulatory Authority in a Major Country in the EU, a nd ( c ) in Japan, receipt by [COMPANY] of written notice of acceptance of f iling of such NDA from the Japanese Ministry of Hea lth, Labour andWelfare ( )