Institution and Investigator agree to comply with this Agreement, the Protocol, requirements of the IRB in connection with the Study, and all applicable federal, state and local laws and regulations, including but not limited to the privacy regulations issued pursuant to the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), 45 C.F.R. Parts 160 & 164. Institution and Investigator agree that it will appropriately safeguard protected health information (“PHI”).  As used in this Agreement, PHI shall have the meaning of that term as defined in the HIPAA privacy regulations. The Investigator and Institution shall handle all Study data, including medical records of Study participants, in accordance with HIPAA requirements and all other applicable laws.  The Investigator and Institution shall obtain from each Study participant a valid authorization that complies with HIPAA before the Investigator or Institution provide any Study data to Sponsor.