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 Biologics Price Competition and Innovation Act of 2009, U.S.C. 262,Section 351 of the Public Health Service Act, or, outside the United States, in accordance with European Directive2001/83 / EC on the Community Code for medicinal products ( Article 10(4 ) and Section 4, Part II of Annex I ) and EuropeanRegulation EEC/2309/93 establishing the Community procedures for the authorisation and evaluation of medicinal products, each as amended, and together with all associated guidance, and any counterparts thereof or equivalent process outside ofthe US or EU to the foregoing, in each case that relies on or incorporates data generated by Naia or any of its Aﬃliates orSublicensees for the corresponding Licensed Product under this Agreement in connection with such approval