definiens: shall mean, with respect to any Specific Product, the earlier of ( a ) November 30, 2011 or ( b ) thefirst date on which all of the following events have occurred ; ( i ) any Third Party receives from the FDA final approval foran ANDA to commercially sell a pharmaceutical product for use in humans containing atorvastatin calcium as the soleactive ingredient, determined by the FDA to be bioequivalent and designated by the FDA to be AB - rated to Lipitor ( the ), and ( ii ) such Third Party has made the Generic Product available for purchase in commercialquantities ( meaning at least 10 % or more availability ) to major wholesalers, retail pharmacy chains and managed careproviders sufficient to meet a significant portion ( at least 10 % ) of such Third Party ’s initial stocking requirements ), asmutually determined by the Parties, in the Territory ; it being understood and agreed that in no event will theCommencement Date occur prior to the Effective Date ( as defined in Section 2.1 below )