definiens: means, with respect to the Product, a generic pharmaceutical product that istherapeutically equivalent to the Product, where “ therapeutically * * * * * Confidential treatment requested pursuant to a request for confidential treatment filed with the Securitiesand Exchange Commission ; omitted portions have been separately filed with the Commission 7 equivalent ” means : ( i ) for purposes of the United States, an AB rating is assigned to the product ’s entry in the list ofdrug products with effective approvals published in the then - current edition of FDA ’s publication and any current supplement to the publication ( also known as the ) referred to in 21 C.F.R. 314.3 and such product is covered by an Abbreviated New Drug Application(as defined in the FD&C Act ) or an application under Section 505(b)(2 ) of the FD&C Act which primarily relies on theProduct ’s NDA as the reference listed drug ; and ( ii ) for purposes of other countries in the Territory, a rating equivalentto the FDA ’s AB rating is assigned to the product by that country ’s Regulatory Authority and such product reliesprimarily on the Regulatory Approval of the Product in that country for approval