Common use of Control of Pre-Phase III Development Activity Clause in Contracts

Control of Pre-Phase III Development Activity. All Development of Licensed Product by PPD performed prior to Xxxxxxx exercising the Xxxxxxx Option will be done in accordance with the Pre-Phase III Development Plan. PPD shall, directly or through its Affiliates, or subcontractors, have full control over implementation of all aspects of a Licensed Product’s Development in accordance with the Pre-Phase III Development Plan and shall, except as explicitly provided in this Agreement or the TOPO Master Services Agreement, be solely responsible for all costs and expense associated therewith. PPD shall keep and maintain all records required by law or regulation with respect to Licensed Products. Subject to the assignment of Existing IND(s) to PPD by Xxxxxxx pursuant to Section 2.2, PPD shall, except as may be specified in the TOPO Master Services Agreement, have responsibility for submitting all necessary Regulatory Documentation with respect to the Existing IND(s) to perform its obligations under this Section 2.1, and, except as may be specified in the TOPO Master Services Agreement, shall assume full responsibility for the non-clinical and clinical activities pursuant to and in support of such Pre-Phase III Development Plans. PPD shall use Diligent Efforts to Complete the Pre-Phase III Development Plan for the Licensed Product. PPD shall use Diligent Efforts to deliver the Option Criteria to Xxxxxxx for the Licensed Product.