definiens: means, with respect to a Licensed Product, any pharmaceutical productthat ( i ) contains an active ingredient the same as or similar to the Licensed Compound in such Licensed Product, ( ii)is distributed by a Third Party which is not a Sublicensee or Affiliate thereof under a Drug Approval Applicationapproved by a Regulatory Authority ( a ) in the U.S. pursuant to Section 505(b)(2 ) or Section 505(j ) of the FFDCA ( 21U.S.C. 355(b)(2 ) and 21 U.S.C. 355(j ), respectively ), ( b ) in the EU pursuant to a provision of Articles 10, 10a or 10b ofParliament and Council Directive 2001/83 / EC as amended ( including an application under Article 6.1 of Parliament andCouncil Regulation ( EC ) No 726/2004 that relies for its content on any such provision ) or ( c ) in any other country orjurisdiction pursuant to all equivalents of such provisions based on a demonstration of bioequivalence or similarity tosuch Licensed Product and in reliance, in whole or in part, on the prior approval ( or on safety or efficacy datasubmitted in support of the prior approval ) of such Licensed Product, and ( iii ) may be substituted under ApplicableLaw as a therapeutic equivalent to such Licensed Product when dispensed without the intervention of a physician orother health care provider with prescribing authority