Kiniksa Clinical Supply for GNE Development Sample Clauses

Kiniksa Clinical Supply for GNE Development. Kiniksa shall provide to GNE drug product, drug substance, and placebo controls (including in each case related reference standard materials and diluents) for the Lead Antibody consisting of an “Initial Drug Supply” and a “DP Resupply,” as each such term is further defined on, and in accordance with, Appendix 6.1.2.2. The Initial Drug Supply and the DP Resupply shall each conform to the requirements of Section 6.1.2.5 (Additional Clinical Supply Obligations and Specifications) and be delivered by Kiniksa to GNE in the quantities specified in Appendix 6.1.2.2 by no later than [***] days after the Effective Date for the Initial Drug Supply and [***] for the DP Resupply (each such date as applicable, the “Required Supply Date”); provided that Kiniksa shall use Commercially Reasonable Efforts to deliver the DP Resupply by [***]. The Initial Drug Supply and DP Resupply shall be manufactured and supplied by Kiniksa at its own cost but will be subject to a fixed payment subject to and in accordance with Section 9.2 (Fee upon Satisfaction of Clinical Supply by Required Supply Dates). Any failure by Xxxxxxx to deliver to GNE the Initial Drug Supply and DP Resupply by the applicable Required Supply Date shall not release Kiniksa from its obligation under this Agreement to supply such Initial Drug Supply and DP Resupply in accordance with the terms of this Agreement; provided that, if Xxxxxxx is unable to deliver the DP Resupply by the applicable Required Supply Date due to one or more batch failures in the manufacture thereof (and, subject to Section 5.6.3(b), such failure results in GNE not being obligated to pay Kiniksa the amount set forth in Section 9.2 (Fee upon Satisfaction of Clinical Supply by Required Supply Dates)), then at GNE’s request, Xxxxxxx shall complete its obligation to supply such DP Resupply to GNE as soon as practicable and GNE will reimburse Kiniksa’s [***] for the manufacture thereof. ​
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