definiens: means, with respect to a Licensed Product in a country, any pharmaceutical product sold by a Third Party not authorized by or on behalf of ROCHE or its Affiliates, that ( a ) contains as an active phannaceutical ingredient the same CRAC Charmel Inhibitor ( or its pro - drug, metabolite, constitutional or geometric isomer, regioisomer, stereoisomer including enantiomer or diastereoisomer . salt fonn, hydrate, solvate or polymorph of such CRAC Channel Inhibitor ) . as the one contained in such Licensed Product, ( b ) is to such Licensed Product as such tenn is used in the Approved Drug Products with Therapeutic Equivalence Evaluations published by the FDA Center for Drug 5 CONFIDENTIAL EXECUTION COPY Evaluation and Research or any successor publication, and ( c ) is approved in reliance on the prior approval of such Licensed Product as determined by the applicable Regulatory Authority in such country