Common use of CRO Services by PPD Clause in Contracts

CRO Services by PPD. (i) If Xxxxxxx exercises the Xxxxxxx Option, Xxxxxxx agrees to utilize PPD Development, LP or an Affiliate thereof to perform all Phase III Trials that are required for obtaining Regulatory Approval for the primary indication of treatment of cSSSI and CABP caused by MRSA (the “Primary Indication), and not to have any such Phase III Trials performed by Xxxxxxx, its Affiliates, or any other Third Party. In the event that Xxxxxxx elects to use a party other than Xxxxxxx or any Affiliate thereof to perform any non-clinical services related to such Phase III Trials or the related pursuit of Regulatory Approval of any Licensed Product, including without limitation, biostatistical/data management or analytical or bioanalytical services related to such clinical trials of Licensed Products or that are otherwise performed in support of obtaining any related Regulatory Approvals for any Licensed Product, Xxxxxxx agrees to utilize PPD Development, LP or an Affiliate thereof to perform all such additional services, and not to have any such services performed by any Third Party.

CRO Services by PPD. (i) If Xxxxxxx exercises the Xxxxxxx Option, Xxxxxxx agrees to utilize PPD Development, LP or an Affiliate thereof to perform all Phase III Trials that are required for obtaining Regulatory Approval for the primary indication of treatment of cSSSI and CABP caused by MRSA diarrhea predominant irritable bowel syndrome (the “Primary Indication), and not to have any such Phase III Trials performed by Xxxxxxx, its Affiliates, or any other Third Party. In the event that Xxxxxxx elects to use a party other than Xxxxxxx or any Affiliate thereof to perform any non-clinical services related to such Phase III Trials or the related pursuit of Regulatory Approval of any Licensed Product, including without limitation, biostatistical/data management or analytical or bioanalytical services related to such clinical trials of Licensed Products or that are otherwise performed in support of obtaining any related Regulatory Approvals for any Licensed Product, Xxxxxxx agrees to utilize PPD Development, LP or an Affiliate thereof to perform all such additional services, and not to have any such services performed by any Third Party.