Inspections of PPD. PPD agrees to promptly notify Sponsor of a regulatory inspection of PPD in which Sponsor’s project is the scope of the inspection. Sponsor agrees to provide PPD support during the inspection as needed relative to the Services contracted and Project. PPD agrees to provide updates to Sponsor as to the progress of the inspection relative to the Services and Sponsor project.
Inspections of PPD. PPD agrees to promptly notify Sponsor of a regulatory inspection of PPD in which Sponsor’s project is the scope, in whole or in part of the inspection may be affected by such inspection. PPD shall permit Sponsor to be present for any inspection in which Sponsor’s project is the scope, in whole or in part, of the inspection. Sponsor agrees to provide PPD support during the inspection as needed relative to the Services contracted and Project. PPD agrees to provide updates to Sponsor as to the progress of the inspection relative to the Services and Sponsor project. PPD shall provide to Sponsor copies of any correspondence from any regulatory or governmental agency relating to such inspection related to, or which may affect Sponsor’s study, including by not limited to, Form FDA 483 notices and warning letters (regardless of whether such documents reference Sponsor). PPD shall notify Sponsor before referring to any Sponsor or any Project in any regulatory correspondence, however PPD may respond independently if required by applicable law or regulation. PPD shall ensure that it discloses information related to the Sponsor or the Project only to the extent required by the regulatory authority and shall not disclose more information than the minimum necessary to comply with the request of the regulatory authority. PPD shall not disclose information and materials that are not required to be disclosed to such authority without the prior consent of Sponsor which shall not be unreasonably withheld. Notwithstanding the foregoing, PPD shall not be obligated to take any action prohibited by a regulatory authority.
