definiens: means, with respect to a Licensed Product, on a country -by - country basis, a pharmaceutical product that : ( a ) is sold in a given country by a Third Party, other than a Sublicensee, or any other Third Party in a chain of distribution originating from Roivant, any of its Affiliates or any Sublicensee ; ( b ) contains the same Proprietary Drug ( and, if such Licensed Product is a fixed -dose combination that also contains any Active Pharmaceutical Ingredient in additi on to Oxybutynin and Pilocarpine, the same such other Active Pharmaceutical Ingredient ) as such Licensed Product ; and ( c ) has been approved for marketing by the relevant Regulatory Authority in such country in reliance on the approved MAA for such Licensed Product in such country, including any such pharmaceutical product that has been approved for marketing ( i ) in the U.S., pursuant to Section 505(b)(2 ) or Section 505(j ) of the Act ( 21 U.S.C