Failure to obtain US Marketing Sample Clauses

Failure to obtain US Marketing. Approval in the U.S. (a) Subject to the terms of this Agreement, in the event a first Marketing Approval is not obtained in the U.S. for the First Indication by December 31, 2019 (“US Marketing Approval”), then, subject to subsection (b) of this Section 15.3.3, KHK may terminate this Agreement solely with respect to the Profit Share Territory by providing Notice to UGNX within thirty (30) days following the expiration of such deadline. (b) Notwithstanding Section 15.3.3(a) above, upon receipt of KHK’s Notice under the preceding sub-clause (a), UGNX may, by providing Notice to KHK within thirty (30) days of receipt of such KHK’s Notice, elect to obtain a one-time extension of the deadline set forth in Section 15.3.3(a) for two (2) years in consideration for the payment to KHK of a fee equal to Ten Million US Dollars ($10,000,000) (“US Extension Period”). For clarity, during the US Extension Period, Development Costs in the Profit Share Territory shall be shared by the Parties as set forth in Section 4.9.1. If US Marketing Approval is not obtained by the end of the US Extension Period, KHK may terminate the Agreement solely with respect to the Profit Share Territory by providing Notice to UGNX within thirty (30) days following the expiration of the US Extension Period. (c) In addition, UGNX may extend the deadline set forth in Section 15.3.3(a) in order to recover and reflect the following excusable delays: safety issues, KHK’s failure to comply with this Agreement, delays related to manufacturing and CMC, delays caused by KHK’s failure to agree on matters subject to joint decision-making and Force Majeure Events.
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Related to Failure to obtain US Marketing

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