PRECISION WES

AGREEMENT FOR DISCLOSURE AND TRANSFER OF CONFIDENTIAL INFORMATION AND DE-IDENTIFIED DATA DUKE university

AGREEMENT FOR DISCLOSURE AND TRANSFER OF CONFIDENTIAL INFORMATION AND DE-IDENTIFIED DATA This Agreement for Disclosure and Transfer of Confidential Information and De-Identified Data (“Agreement”) is effective as of the date of the last signature below by and between Duke University, a tax-exempt research and educational institution located in Durham, North Carolina acting for and on behalf of its School of Medicine (“Duke”) and XXXX (“Recipient”), located in XXXX. WHEREAS, Duke wishes to share de-identified data without a link field from a human subjects research study entitled “XXX” (Duke IRB# Pro000XXXX/ Duke Investigator: XXXX) (the “Study”) with Recipient’s investigator, XXXXX (“Investigator”) so that Recipient may use the information to XXXX (the “Purpose”); and WHEREAS, Recipient will be provided with, or will have access to de-identified information on research subjects (“Subject Information”) and other information that Duke considers to be confidential (“Confidential Information”) (together Subject Information and Confidential Information shall be referred to as “Information”). NOW, THEREFORE, the parties hereby agree to the following terms and conditions: 1. Recipient agrees that it shall treat the Information in strict confidence and shall avoid disclosure of any Information to any other person, firm or corporation, other than those who have a need to know the Information in order to carry out the Purpose of this Agreement and who are subject to confidentiality obligations sufficient to carry out the intent of this Agreement. Recipient shall not transfer or sell the Information to others or attempt to identify or contact any Study subjects. Duke certifies that (i) the Subject Information was collected in accordance with the informed consent provided by the individuals to whom it relates and that such informed consents do not prevent the use of the Subject Information for the Purpose set forth herein or (ii) there is no informed consent and Duke’s IRB has determined that no such consent is required. Recipient is responsible for obtaining and complying with any review or approval required by Recipient’s IRB or by Recipient’s policies. Duke’s obligation to provide the Subject Information shall be subject to approval of this transfer by the Duke IRB. 2. Recipient shall have no obligation, with respect to the Confidential Information or any part thereof that: a. is already known at the time of the disclosure from a source not associated with the applicable Study; b. becomes publicly known without the wrongful act or breach of this Agreement by a party; c. is rightfully received by Recipient from a third party not associated with the Study on a nonconfidential basis; d. is approved for release by written authorization of Duke; e. is independently developed by Recipient without use of or reliance upon the Confidential Information; or f. is required to be disclosed by law or a court order. 3. Duke certifies that the Information does not contain any human subject data that will allow a subject to be identified. If any Information that constitutes Protected Health Information (“PHI”) as defined in the Health Insurance Portability and Accountability Act of 1996, as amended, is transferred unintentionally, the PHI shall be kept in strict confidence without limitation of time, notwithstanding Article 4 below. 4. Recipient’s obligations of confidentiality with respect to Confidential Information shall continue for a period of five (5) years after the first to occur of termination of this Agreement or until Recipient returns or destroys the Information pursuant to Section 6 below. 5. Recipient is responsible for the security of the Information and shall ensure that it and its contractors adopt, implement and maintain appropriate security controls, including but not limited to encryption in transit, to protect against unauthorized access of the Information or personally identifiable information of any Duke employees, agents or customers. All transmission of the Information shall be through Duke approved methods.  Recipient accepts responsibility and liability for any unauthorized disclosure by it or its contractors and shall notify Duke immediately in the event of any breach of data security or unauthorized release of Information or personally identifiable information of Duke employees, agents, or customers and take appropriate steps to limit any further such use or disclosure. 6. Recipient shall use the Information solely for the Purpose and shall not be entitled to make any other use of the Information. No license or additional rights are provided to either party under any patent applications, copyrights, trade secrets, or other proprietary rights of the other party. Upon completion of the Purpose, Collaborator shall return the Information to Duke, or at Duke’s election, destroy all Information and provide Duke with written certification of such destruction. This Agreement shall terminate upon the return or destruction of the Information. Collaborator shall not transfer, license, sell or commercialize the Information or attempt to identify or contact any Study subjects. Collaborator shall ensure that any Collaborator agents or subcontractors are subject to the same or substantively similar terms provided in this Agreement. 7. This Agreement may not be assigned by either party without the prior written consent of the other. 8. This Agreement represents the entire understanding between the parties, and supersedes all other agreements, express or implied, between the parties as to its subject matter. Any alteration, modification, or amendment to this Agreement must be in writing and signed by authorized representatives of each party. IN WITNESS WHEREOF, the parties have signed or caused this Agreement to be signed as of the dates indicated below. Duke University XXXXXXXX By:_________________________ By:_____________________ Susan E. Hayden, J.D. Name: Director, Research Program Collaborations Title: Office of Research Contracts Date signed: Date signed: Read and Understood by Investigator: By:___________________ Name: Date: