definiens: means, with respect to a Licensed Product or a Co - Developed Product, any pharmaceuticalproduct that ( i ) contains as an active ingredient an agent that is the same or substantially the same as the Licensed Compoundcontained in such Licensed Product or Co - Developed Product, ( ii ) obtained regulatory approval ( for an indication for whichthe Licensed Product or Co - Developed Product, as applicable, obtained Regulatory Approval from the applicable RegulatoryAuthority ) on an expedited or abbreviated basis in a manner that relied on or incorporated data submitted by [COMPANY] or any ofits Affiliates or Sublicensees in connection with the Regulatory Approval for such Licensed Product or Co - Developed Productand ( iii ) is sold in the same country as such Licensed Product or Co - Developed Product by any Third Party that is not aSublicensee of [COMPANY] or its Affiliates and did not purchase such product in a chain of distribution that included any of [COMPANY] orany of its Affiliates or its Sublicensees . Generic Product, with respect to a Licensed Product, shall also include anypharmaceutical product that ( x ) contains as an active ingredient an agent that is the same or substantially the same as theLicensed Compound contained in such Licensed Product, ( y ) obtained regulatory approval in the Cancer Field from theapplicable Regulatory Authority on an expedited or abbreviated basis that relied on data submitted by Alder or any of itsAffiliates or licensees in connection with the Regulatory Approval for such Cancer Product and ( z ) is sold and used off - labelin the Licensed Field in the same country as such Licensed Product by any Third Party that is not a licensee of Alder or itsAffiliates and did not purchase such product in a chain of distribution that included any of Alder or any of its Affiliates or itslicensees