definiens: means, in a particular country with respect to a particular LicensedProduct, any biopharmaceutical product that : ( a ) has received all necessary approvals by the applicable RegulatoryAuthorities in such country to market and sell such product as a biopharmaceutical product ; ( b ) is marketed or sold by aThird Party that either ( i ) has not obtained the rights to market or sell such product as a Sublicensee or as a distributor ofKite or any of its Affiliates or Sublicensees, in each case with respect to such Licensed Product or ( ii ) received the right tomarket or sell such product pursuant to a license or settlement, in each case in connection with litigation with Kite, itsAffiliate or a Sublicensee under the Biologics Price Competition and Innovation Act of 2009 or an equivalent under foreignlaw ; and ( c ) is approved as ( i ) a 2 [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities andExchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended