definiens: means any product for which Regulatory Approval is sought under ( a ) the U.S. Biologics PriceCompetition and Innovation Act of 2009 ( or any amendment or successor statute thereto ) referencing a Product, or ( b)any certification under a similar statutory or regulatory requirement in any non - United States country in the Territory, ineach case where the applicant for such Regulatory Approval claims that a XOMA Patent Covering any Product isinvalid or that infringement will not arise from the development, manufacture or commercialization of such product by aThird Party . A product shall not be considered to be a Biosimilar if ( i ) [COMPANY] or any of its Affiliates or sublicenseeswas involved in the Development of such product, or ( ii ) such product is commercialized by any sublicensee ofNovartis or any of its Affiliates or by any Person who obtained such product in a chain of distribution that includedNovartis or any of its Affiliates or sublicensees )