definiens: means, with respect to the Licensed Product which has received RegulatoryApproval in the United States of America, a generic version of the Licensed Product which has received RegulatoryApproval from the FDA ( x ) under an abbreviated NDA which refers to the Licensed Product as the Reference ListedDrug ( as defined in 21 C.F.R. 314.3(b ) ), ( y ) under an NDA described in Section 505(b)(2 ) of the Act as to whichinformation necessary for approval is contained in the NDA filed as part of the Program for the Licensed Product butas to which the applicant in the NDA for such potential Generic Equivalent does not have a right of reference, or ( z ) byany means by which such generic version can obtain Regulatory Approval based, in part, on information contained inthe NDA filed for the Licensed Product but as to which the applicant in the application for Regulatory Approval forsuch potential Generic Equivalent does not have a right of reference