definiens: means, with respect to the Product, a generic pharmaceutical product that istherapeutically equivalent to the Product, where means : ( i ) for purposes of the UnitedStates, an AB rating is assigned to the product ’s entry in the list of drug products with effective approvals published inthe then - current edition of FDA ’s publication andany current supplement to the publication ( also known as the ) referred to in 21 C.F.R. 314.3 and suchproduct is covered by an Abbreviated New Drug Application ( as defined in the FD&C Act ) or an application underSection 505(b)(2 ) of the FD&C Act which primarily relies on the Product ’s NDA as the reference listed drug ; and ( ii ) forpurposes of other countries in the Territory, a rating equivalent to the FDA ’s AB rating is assigned to the product bythat country ’s Regulatory Authority and such product relies primarily on the Regulatory Approval of the Product in thatcountry for approval