definiens: shall mean, with respect to a Licensed Product sol d by Naia, an Affiliate thereof, or a Sublicensee hereunder, and on a count ry - by - country basis, a product that ( a ) is marketed for sale in such country by a Third Party for the same Indicati on as such Licensed Product ( or an Indication inclu ded within the Indication for which such Licensed Product is s old ) ; ( b ) contains the corresponding Licensed Produ ct or substantial equivalent(s ) of the active pharmaceuti cal ingredient(s ) of the corresponding Licensed Pro duct in such country ; and ( c ) such product, as and to the extent required, is approved through an abbreviated proce ss ( similar, with respect to the United States, to an Abbreviate d New Drug Applications under Section 505(j ) of the Federal Food, Drug and Cosmetic Act ( 21 USC 355(j ) ) or is a pproved as a under Ti tle VII, Subtitle A Biologics Price Competition and Innovati on Act of 2009, U.S.C. 262, Section 351 of the Publ ic Health Service Act, or, outside the United States, in acco rdance with European Directive 2001/83 / EC on the Co mmunity Code for medicinal products ( Article 10(4 ) and Sect ion 4, Part II of Annex I ) and European Regulation EEC/2309/93 establishing the Community procedures f or the authorisation and evaluation of medicinal pr oducts, each as amended, and together with all associated g uidance, and any counterparts thereof or equivalent process outside of the US or EU to the foregoing, in each c ase that relies on or incorporates data generated b y Naia or any of its Affiliates or Sublicensees for the correspon ding Licensed Product under this Agreement in conne ction with such approval