definiens: means the written Development plan then approved by the SCJ for Development inJapan, which plan shall include : ( A ) a binding section, which shall indicate those specific Clinical Trials that the Parties have agreed to conductunder this Agreement with respect to Japan, and which shall include, where agreed upon : ( i ) a budget for such Clinical Trials(or a good faith estimate if a firm budget is not reasonably practicable ), ( ii ) any plans involving a CRO for such ClinicalTrials, ( iii ) to the extent known, estimated timelines for the initiation and completion of such Clinical Trials, ( iv ) to the extentknown, key endpoints for such Clinical Trials, ( v ) to the extent known, any specific allocation of responsibilities among theParties with respect to the implementation of such Clinical Trials, ( vi ) if applicable, any go / no - go criteria for a given study, and ( vii ) if applicable, any clinical studies being conducted outside the Development Plan ( and which will not be shared asDevelopment Costs under this Agreement ) that will be used to bridge to or support the Clinical Trials ; and ( B ) a non - binding section, which shall indicate those Indication(s ), new line(s ) of therapy within an Indication, preclinical studies and/or Clinical Trials that the Parties are contemplating but have not yet agreed to conduct with respect toJapan, which section may include ( i ) a good faith estimate of the budget for the Development of the Indications, lines oftherapy, and/or conduct of those studies, ( ii ) any other or related significant Development related activities contemplated forJapan, ( iii ) any plans involving a CRO, ( iv ) to the extent known, estimated timelines, ( v ) to the extent known, key regulatoryactivities and any material regulatory strategies relating to such Indications, lines of therapy, and/or studies, and ( vi ) anycontemplated allocation of responsibilities among the Parties with respect to the implementation of the Long - TermDevelopment Plan