definiens: means with respect to a Licens ed Product in the Territory, a product that : ( a ) is available in a region in the Territory by a Third P arty ( not licensed, supplied or otherwise permitted by Hansoh or its Affiliates or licensees or either of their p ermitted sublicensees ) ; ( b ) contains the Licensed C ompound or substantial equivalent in such region ; ( c ) is subst antially similar to the Licensed Product with respe ct to its safety, efficacy, manufacturability and disposition ; and ( d ) is approved by the NMPA or other equivale nt Regulatory Authority in such region as a generic or a biosimilar drug in accordance with the Technical Guideline for the Research, Development and Evaluation of Bio similars ( Tentative ) promulgated by the NMPA ( or an y successor guidance or legislation ) or other applica ble guidelines, regulations or laws of the equivale nt Regulatory Authority in such region or country