definiens: is defined in Section 13.6.1.1.5 is defined in Section 7.2.6(b).CONFIDENTIALExecution Copy 1.6 means, in a particular country with respect to aLicensed Therapeutic Product, any product that : ( a ) has received all necessary approvalsby applicable Regulatory Authorities in such country to market or sell such product as apharmaceutical product ; ( b ) is marketed or sold by a Third Party that has not obtained therights to market or sell such product as a licensee, sublicensee or distributor of FivePrimeor any of its Affiliates, licensees or sublicensees with respect to such product ; and ( c ) isapproved as a ( i ) ( in the United States ) of such Licensed Therapeutic Product,(ii ) as a ( in the EU ) with respect to which suchLicensed Therapeutic Product is the or ( iii ) if not the US or EU, as aforeign equivalent of a or of suchLicensed Therapeutic Product ; in each case for use in such country pursuant to anexpedited regulatory approval process governing approval of generic biologics based onthen - current standards for regulatory approval in such country ( e.g