definiens: means, with respect to a particular Product, any pharmaceutical product that meets all of the following conditions : ( a ) it is sold by a Third Party that is not a sublicensee of Dermavant or its Affiliates and did not obtain such pro duct in a chain of distribution that includes any of Dermavant, its Affiliates or sublicensees ; ( b ) it contains the same Licensed Compound as an Active Ingredient and is a topical application ; and ( c ) ( i ) for purposes of the United States, it is approved i n reliance on the prior approval of such Product as determined by the FDA, or ( ii ) for purposes of a country outside the United States, it is approved in reliance on the prior approval of a Product as determined by the applicable Regulatory Authority . Any Product licensed or produced by Dermavant ( e.g. an authorized generic product ) will not constitute a Generic Product