Common use of Design and Modifications to a Pre-Phase III Development Plan; Proposed Development During Xxxxxxx Option Period Clause in Contracts

Design and Modifications to a Pre-Phase III Development Plan; Proposed Development During Xxxxxxx Option Period. In the event PPD desires to make a material modification to the Pre-Phase III Development Plan or perform Development, other than Required Option Development, during the Xxxxxxx Option Period, PPD shall report such change or proposed Development to Xxxxxxx through the JAC (as defined below). The JAC shall consider such change. If the JAC is unable to agree by unanimous vote on such change or proposed Development within five (5) business days of PPD proposing such change or proposed Development, then either Party may refer, in writing, the matter being considered to designated executive officers of Xxxxxxx and PPD for final resolution. If the senior officers are unable to resolve the matter within five (5) business days of the matter being referred to them by either Party, then (i) PPD shall have the right, in its reasonable discretion, to modify the Pre-Phase III Development Plan as proposed to the JAC and (ii) with respect to any Development, other than Required Option Development, proposed during the Xxxxxxx Option Period, PPD shall not be entitled to perform such Development during the Xxxxxxx Option Period. For clarification, modification to the Pre-Phase III Development Plan does not modify PPD’s obligation as to the Option Criteria unless a modification to the Option Criteria is agreed to by Xxxxxxx in writing.