Pediatric Studies Sample Clauses
Pediatric Studies. Future out-of-pocket costs for pediatric studies that exceed the total budgeted costs for such studies approved by the JDC and JCC as of the Effective Date of this Amendment No. 1 shall be […***…] between the Parties.
Pediatric Studies. (a) During the [**] of the Term of this Agreement, Akebia shall have the right, but not the obligation, to elect to conduct a global pediatric clinical program for the Licensed Product to support Regulatory Approval in the United States as well as in the Territory, which would be in lieu of pediatric clinical studies solely to support Regulatory Approval in the Territory. If Akebia elects to exercise this option, then Licensee shall reimburse Akebia [**]% of any and all costs incurred by ▇▇▇▇▇▇ in conducting such Development, up to a limit of no more than $[**].
(b) In the event Akebia does not elect to exercise the option set forth in Section 4.1.2(a) above, then Licensee shall be responsible for conducting any pediatric clinical studies of the Licensed Product required by EMA as of the Effective Date in a manner consistent with the Pediatric Investigation Plan approved by EMA as of the Effective Date. In this instance, Licensee shall be responsible for [**]% of any and all costs incurred in conducting such Development.