definiens: means, with respect to an NDA, MAA or JNDA filed for a Product, ( a ) in the United States, the receipt of writtennotice from the FDA in accordance with 21 C.F.R. § 314.101(a)(2 ) that such NDA is officially ( b ) in the EuropeanUnion, receipt by [COMPANY] Idec of written notice of acceptance by the EMA of such MAA for filing under the centralizedEuropean procedure in accordance with any feedback received from European Regulatory Authorities ; provided that if thecentralized filing procedure is not used, then Acceptance will be determined upon the acceptance of such MAA by theapplicable Regulatory Authority in a Major Country in the EU, and ( c ) in Japan, receipt by [COMPANY] Idec of written notice ofacceptance of filing of such JNDA from the Koseisho ( i.e