definiens: willlmeanahon - Affiliate thirdpartyapprovedbyLEL, suchapprovalnottobeunreasonably withheld, whichPURDUEmayretaintoperformsomeofPURDUE 'S responsibilities herelUlderregarding theLicensed ProductintheTerritory assetforthherein;meansanyproductthafincludesanactiveingredi.ent thatisthesameastheactiveingredient intheLicensedProductNDA, including butnotlimitedto, anyprodnctwhichissubmitted forregulatory approvalthroughadrugapplication throughSection505(b)(2)or505(j)oftheFederalFood, DrugandCosmetic ActorcoveredbytheLicensedProductNDAoraseparate505(b)(1 ) application basedonaright - of - reference fromPURDUE, when(i)packaged andsoldwithouttheLicensedProductTrademark, ( ii)thesalethereofintheTerritoryisauthorized andlicensedbyPlJRDUE, and(iii)itistherapeuticallyequivalent totheLicensed ProductasthattermisdefinedintheOrangeBookandapplicable FDAregulations ;