definiens: means exerting such efforts and employing such resources as wouldnormally be exerted or employed by a Party for its other drug candidates and pharmaceutical products of acomparable stage of development and commercial potential ; . and for this Agreement, with respect to RegulatoryApproval and First Commercial Sale of Licensed Product, means ( i ) the filing of an IND with the Taiwan RegulatoryAuthority within six months after Kinex provides PharmaEssentia with the IND that Kinex has filed with the UnitedStates Regulatory Authority, ( ii ) assuming that a 505b2 strategy is allowed by Taiwan FDA, enrollment of at least forty(40 ) patients for the Oraxol program within eighteen ( 18 ) months after IND is allowed by the Taiwan FDA,(iii ) assuming that a 505b2 strategy is allowed, enrollment of at least forty ( 40 ) patients for the Oratecan programwithin 18 months after the IND for Oratecan is allowed by the Taiwan FDA, and ( iv ) the filing of an application for aFree Sale Certificate within three ( 3 ) months after the approval of an NDA for each Licensed Product ; provided, however, Kinex shall grant a six month extension on each of the foregoing timelines at the reasonable written requestof PharmaEssentia