definiens: means, with respect to a Licensed Product in a country in the CELGENE Territory, any pharmaceutical produc t that ( A ) contains a highly similar or identical a ctive ingredient(s ) as such Licensed Product ; ( B ) is appr oved for use in such country pursuant to a regulato ry approval process governing approval of generic, interchangea ble or biosimilar biologics based on the then - curre nt standards for Regulatory Approval in such country, whether or not such Regulatory Approval was based u pon clinical data generated by the Parties pursuant to this Agreement or was obtained using an abbreviated, expedited or other process ; and ( C ) is sold in the same count ry as such Licensed Product by any Third Party that is not a Sublicensee of CELGENE or its Affiliates and did no t purchase such product in a chain of distribution that included any of CELGENE or any of its Affiliates or its Sublicensees