REPORTING AND ACCESS. During the term of this Agreement and through the date of the close-out visit performed by Sponsor, University will maintain complete and accurate records of the status and progress of the Study and will provide records to Sponsor upon request. Research results and associated data contained in the Case Report Forms (CRF) and research reports generated pursuant to the Protocol shall be the property of the Sponsor, provided that University will be free to use the research results and associated data generated for any reasonable purpose, including non-commercial research, educational and patient care purposes. University will be free to publish, present and disclose the research results and associated data generated in the Study in accordance with Section 7. Sponsor may utilize all data and results for any reasonable purpose, including regulatory submissions. University and Principal Investigator, in cooperation with Sponsor, shall prepare and maintain records, reports and data as provided in the Protocol, and in accordance with all applicable local, state and federal laws and regulations. University shall cooperate with any regulatory authority with appropriate jurisdiction and allow said authorities reasonable access to relevant study records and data. If Sponsor requests that the University retain records for a period longer than U.S. laws or regulations require, Sponsor may be required to (i) pay for the continued storage of Study records by the University, or (ii) pay for costs associates with shipping such records to Sponsor. Sponsor shall respond promptly to the University’s requests regarding record disposition. University shall not destroy such records without giving Sponsor prior written notice.
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