definiens: means, with respect to a LicensedProduct sold in a country, a product that : ( i ) is marketed by a Third Party that has not obtained the rights to such product as aSublicensee or distributor of, or through any other contractual relationship with, [COMPANY] or any of its Affiliates ; ( ii ) containsthe same or highly similar active ingredient(s ) as the applicable Licensed Product ; and ( iii ) with respect to ( x ) the UnitedStates, has been licensed as a biosimilar or interchangeable biological product by FDA pursuant to Section 351(k ) of thePublic Health Service Act ( 42 U.S.C. § 262(k ) ), as may be amended, or any subsequent or superseding law, statute orregulation, ( y ) the EU, has been approved in reliance on the prior approval of a Licensed Product as a similar biologicalmedicinal product by the European Union pursuant to Directive 2001/83 / EC, as may be amended, or any subsequent orsuperseding law, statute or regulation, and ( z ) any other country, has received analogous regulatory marketing approval inreliance on the prior approval of a Licensed Product from the applicable Regulatory Authority8.5.5 Third Party Offset . If, after the License Grant Date for any Licensed Program, [COMPANY] or its applicable Affiliateor Sublicensee : ( a ) is required, as reasonably determined by [COMPANY] or its applicable Affiliate or Sublicensee, as the case maybe, to obtain a license from any Third Party under any Patents controlled by such Third Party in order to make, have made, use, sell, offer for sale or import a Program DART and/or a Licensed Product from such Licensed Program in any country in theGilead Territory without infringing such Patents, and pursuant to such license is required to pay any amounts to such ThirdParty ( including any upfront, milestone or royalty payments ) in any Calendar Year, or ( b ) is required by any court ofcompetent jurisdiction, in connection with its infringement of any Patents controlled by a Third Party in any country in theGilead Territory with respect to a Program DART and/or Licensed Product from such Licensed Program, to pay any amounts tosuch Third Party ( including any 48 * * * = Portions of this exhibit have been omitted pursuant to a request for confidential treatment . An unredactedversion of this exhibit has been filed separately with the Commission.lump sum or royalty payments ) in any Calendar Year, then [COMPANY] may deduct from the milestone payments and/or royalties(as elected by [COMPANY] in its sole discretion ) that would otherwise be due to [COMPANY] with respect to such Program DART orLicensed Product in such Calendar Year * * * of the amount paid by [COMPANY] or its applicable Affiliate or Sublicensee, as thecase may be, to such Third Party with respect to such Program DART or Licensed Product in such Calendar Year ( where anysuch amounts paid by [COMPANY] or its applicable Affiliate or Sublicensee to such Third Party shall be equitably allocated amongall products of [COMPANY] or its applicable Affiliate or Sublicensee, as applicable, covered by such license or subject to suchinfringement ) ; provided, however, that such deduction shall not reduce ( A ) the amount of milestones due to [COMPANY] withrespect to such Program DART or Licensed Product for such Calendar Year to less than * * * of the amount of milestones thatotherwise would have become due with respect to such Program DART or Licensed Product for such Calendar Year or ( B ) theroyalty rate paid by [COMPANY] in respect of Annual Net Sales of such Licensed Product in such Calendar Year to less than * * * ofAnnual Net Sales of such Licensed Product in such Calendar Year, in each case ( ( A ) and ( B ) ) with any excess deduction carriedover and applied to amounts due to [COMPANY] with respect to such Program DART or Licensed Product in subsequentCalendar Years