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 ) Completion by [COMPANY] of one or more ClinicalStudy(ies ) in New Zealand with a minimum of eighty 3 * * * = Portions of this exhibit have been omitted pursuant to a request for confidential treatment . Anunredacted version of this exhibit has been filed separately with the Commission.(80 ) patients ( and projected to be up to one hundred twenty ( 120 ) patients for Clinical Studies for both Oraxol andOratecan ) within four ( 4 ) years after the approval of the study plan approved by the Steering Committee ( Clause 3.2),(ii ) filing of an application for Regulatory Approval in New Zealand within four ( 4 ) years after the approval of the studyplan approved by the Steering Committee ( Clause 3.2 ), and filing of an application for Regulatory Approval in Australiawithin 12 months of receiving the US or EU application dossier, ( iii ) achieving First Commercial Sale of LicensedProduct in each country in the Territory within 120 days of PBS listed in Australia unless [COMPANY] has reasonablegrounds to believe that by doing so, the rights of third party might be breached . In such a case, payments asindicated in 4.1 e would be postponed till the issue is resolved ; provided, however, Kinex shall grant a six monthextension on the foregoing timelines at the reasonable request of [COMPANY]