definiens: means, with respect to a Licensed Product and on a country - by - country basis, a product that ( a ) is mar keted for sale in such country by a Third Party ( no t licensed or otherwise permitted by JBI, its Affiliates or Subli censees, except in the case of a compulsory license ) ; ( b ) contains the corresponding Licensed Product, Le ad Molecule, Collaboration Molecule, or substantial equivalent as an active pharmaceutical ingredient i n such country ; and ( c ) such product, as and to the extent required, is approved through an abbreviated proces s ( similar, with respect to the United States, to a n Abbreviated New Drug Applications under Section 505 ( j ) of the Act ( 21 USC 355(j ) ) or is approved as a under Title VII, Subt itle A Biologies Price Competition and Innovation A ct of 2009, Section 42 U.S.C. 262, Section 351 of the Pub lic Health Service Act, or, outside the United Stat es, in accordance with European Directive 2001/83 / EC on th e Community Code for medicinal products ( Article 10(4 ) and Section 4, Part II of Annex I ) a nd European Regulation EEC/2309/93 establishing the Community procedures for the authorisation and eval uation of medicinal products, each as amended, and together with all associated guidance, and any coun terparts thereof or equivalent process outside of t he US or EU to the foregoing, in each case that relies on or in corporates data generated by JBI or any of its Affi liates or Sublicensees for the corresponding Licensed Product under this Agreement in connection with such appro val