Territory Pre-Clinical Development Clause Samples
Territory Pre-Clinical Development. In connection with the Clinical Development of the Licensed Product pursuant to a given Territory Development Plan, Partner may identify, on a country-by-country or region-by-region basis, certain Pre-Clinical Development that is required in order to obtain Regulatory Approval of the Licensed Product in such country or region (“Required Pre-Clinical Development”). [***] If the JSC approves a Pre-Clinical Development Plan, then Kiniksa will have [***] days following the date of such approval by the JSC to determine whether it will either perform or permit Partner to perform such Required Pre-Clinical Development in accordance with the Pre-Clinical Development Plan. If Kiniksa elects to perform such Required Pre-Clinical Development, then Kiniksa will (a) provide to Partner a budget for such Pre-Clinical Development, to be included under the Pre-Clinical Development Plan, (b) use reasonable efforts to perform the Required Pre-Clinical Development in accordance with the applicable Pre-Clinical Development Plan (including the budget therein), and (c) deliver all results therefrom to Partner in accordance with Section 4.3 (Continuing Know-How Transfer) or as otherwise specified in the Pre-Clinical Development Plan. Partner will reimburse Kiniksa for its documented costs and expenses incurred performing such Required Pre-Clinical Development. If Kiniksa elects not to perform the Required Pre-Clinical Development as set forth in the applicable Pre-Clinical Development Plan, or fails to notify Partner of its decision within such [***] day time period, then (i) Partner will have the right to perform, at its cost and expense, the Required Pre-Clinical Development in accordance with the applicable Pre-Clinical Development Plan, and (ii) only in such case, will Partner have the right to practice under the non-exclusive license under the Kiniksa Technology granted pursuant to Section 2.1 (Licenses Granted to Partner) solely with respect to the performance of the Pre-Clinical Development in accordance with the applicable Pre-Clinical Development Plan.