Common use of Data Access and Use Clause in Contracts

Data Access and Use. (A) The data generated by the IC under this Agreement are the property of IC. IC will provide Entity with copies of Study Data (which exclude Identifiable Private Information), if requested, but access and review of Raw Data will only be in accordance with the restrictions under this Article 7. If Entity requires Study Data to be reformatted, it is understood that IC will not expend resources to reformat the Study Data. Entity may directly provide funds to IC’s contractor for the cost of this reformatting. In no event shall the payment of these costs by Entity be considered a receipt, payment or credit under the IC contractor’s contract with the government. This transaction between the Entity and IC’s contractor must occur outside of, and irrespective of, the contractor’s contract with the government. (B) The Study Data provided by IC or IC’s contractor to Entity may be used by Entity for (1) internal research purposes; (2) Test Article development purposes which may include work with third party collaborators, provided they are under obligations of confidentiality substantially similar to those set forth in this Agreement; (3) publications in accordance with the terms of Article 10 below; and (4) regulatory and patent filings. (C) Entity may access and review Raw Data (which may include Identifiable Private Information) for the purposes of (1) on-site quality auditing and co-monitoring; (2) meeting the reporting requirements of the FDA or other U.S. or foreign health authorities; or (3) internal research purposes directly related to obtaining regulatory approval of the Test Article. Additionally, Entity’s access, review, receipt, or use of such information is limited to the permissions explicitly contained in the patient informed consent form.

Data Access and Use. (A) The data generated by the IC under this Agreement are the property of IC. IC will provide Entity with copies of Study Data (which exclude Identifiable Private Information), if requested, but access and review of Raw Data will only be in accordance with the restrictions under this Article 7. If Entity requires Study Data to be reformatted, it is understood that IC will not expend resources to reformat the Study Data. Entity may directly provide funds to IC’s contractor for the cost of this reformatting. In no event shall the payment of these costs by Entity be considered a receipt, payment or credit under the IC contractor’s contract with the government. This transaction between the Entity and IC’s contractor must occur outside of, and irrespective of, the contractor’s contract with the government. (B) The Study Data provided by IC or IC’s contractor to Entity may be used by Entity for (1) internal research purposes; (2) Test Article development purposes which may include work with third party collaborators, provided they are under obligations of confidentiality substantially similar to those set forth in this Agreement; (3) publications in accordance with the terms of Article 10 below; and (4) regulatory and patent filings. (C) Entity may access and review Raw Data (which may include Identifiable Private Information) for the purposes of (1) on-site quality auditing and co-monitoringmonitoring after reasonable advance notice and only during regular business hours; (2) meeting the reporting requirements of the FDA or other U.S. or foreign health authorities; or (3) internal research purposes directly related to obtaining regulatory approval of the Test Article. Additionally, Entity’s access, review, receipt, or use of such information is limited to the permissions explicitly contained in the patient informed consent form.