definiens: means, as to any specific Prod uct or Additional Product at issue which has receiv ed Regulatory Approval in the country at issue, an AB rated generic version ( or equivalent rationale for substitution ) of such Product or Additional Product ( including having the same means of introducing Co mpound into the body of a patient ) which has received Regu latory Approval in such country as follows : ( i ) in the United States, from the FDA ( x ) under an abbreviated NDA w hich refers to the specific product at issue as the Reference Listed Drug ( 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 which information necessary for appro val is contained in the NDA filed as part of the Pr ogram for the specific product at issue but as to which the a pplicant in the NDA for such potential Generic Equi valent does not have a right of reference or ( z ) by any means b y which the potential Generic Equivalent can obtain Regulatory Approval based, in part, on information contained in the NDA filed as part of the Program f or the specific product at issue but as to which the appli ca nt in the application for Regulatory Approval for such potential Generic Equivalent does not have a right of reference granted by the NDA holder ; and ( ii ) in any other country in the Territory, from the Regulatory Autho rity having jurisdiction in such country ( x ) under an application similar to an abbreviated NDA which ref erences the specific Product at issue in a manner s imilar to a Reference Listed Drug, ( y ) under an application sim ilar to an NDA described in Section 505(b)(2 ) of th e Act as to which information necessary for approval is cont ained in the NDA filed as part of the Program for t he specific product at issue ( or the comparable application fil ed as part of the Program in any country at issue ) but as to which the applicant in the application for such pot ential Generic Equivalent does not have a right of reference or ( z ) by any means by which the potential Generic Equ ivalent can obtain Regulatory Approval based, in pa rt, on information contained in 4 PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED WITH THE SECURITIES AN D EXCHANGE COMMISSION ( THE ) . THE OMISSIONS HAVE BEEN INDICATED BY ASTERISKS ( ), AND THE OMITTED TEXT HAS BEEN FILED SEPARATELY WITH THE COM MISSION