definiens: means with respect to an NDA or MAA filed for a Pr oduct, ( a ) in the United States, the receipt by GSKor its Affiliate or Sublicensee of written notice f rom the FDA in accordance with 21 CFR 314.101(a)(2 ) that such NDA isofficially, ( b ) in the European Union, rece ipt by [COMPANY] or its Affiliate or Sublicensee of writt en notice of acceptance bythe EMEA of such MAA for filing under the centraliz ed European procedure in accordance with any feedba ck received fromEuropean Regulatory Authorities ; provided, that if the [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THESECURITIES EXCHANGE ACT OF 1934, AS AMENDED.centralized filing procedure is not used, then Acce ptance shall be determined upon the acceptance of s uch MAA by theapplicable Regulatory Authority in the third Major Country in the EU, and ( c ) in Japan, receipt by [COMPANY] or its Affiliate orSublicensee of written notice of acceptance of fili ng of such MAA from the MHLW