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3(b) of the MCTA as a component of the site activation package; WHEREAS, Investigator desires to participate in the CLARION Trial in the capacity and at the site identified herein, and acknowledges the importance of the obligations set forth in this Undertaking to the integrity of the Study and the safety and welfare of study subjects; NOW, THEREFORE, in consideration of the foregoing recitals and the mutual covenants and agreements set forth herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Investigator agrees as follows: Capitalized terms used but not otherwise defined in this Undertaking shall have the meanings ascribed to them in the MCTA, unless the context requires otherwise

Without limiting the generality of the foregoing, Investigator shall adhere to (a) all subject inclusion and exclusion criteria as specified in Protocol Sections 5

Investigator further agrees to comply with the tumor assessment schedule and to ensure timely submission of imaging data to the independent radiology review center designated by Sponsor

Investigator shall report all protocol deviations to Sponsor, Meridian Contract Research Organization, Inc

The Delegation Log shall be updated promptly to reflect any additions, removals, or changes in delegated responsibilities and shall be available for review during monitoring visits, audits, and inspections

Investigator shall comply with all applicable U