definiens: shall mean, with respect to a Licensed Product sold by Naia, an Aﬃliate thereof, or aSublicensee hereunder, and on a country - by - country basis, a product that ( a ) is marketed for sale in such country by a ThirdParty for the same Indication as such Licensed Product ( or an Indication included within the Indication for which suchLicensed Product is sold ) ; ( b ) contains the corresponding Licensed Product or substantial equivalent(s ) of the activepharmaceutical ingredient(s ) of the corresponding Licensed Product in such country ; and ( c ) such product, as and to theextent required, is approved through an abbreviated process ( similar, with respect to the United States, to an AbbreviatedNew Drug Applications under Section 505(j ) of the Federal Food, Drug and Cosmetic Act ( 21 USC 355(j ) ) or is approved asa under Title VII, Subtitle A Biologies Price Competition and Innovation Act of 2009, U.S.C