Common use of Participant Obligations Clause in Contracts

Participant Obligations. Participant agrees: 1. To provide Participant Data, as applicable, to Michigan, in accordance with frequency, data, and upload specification to be provided by the coordinating center, for the sole and limited purpose of enabling Michigan to receive, process, use, and distribute the Participant Data to MPOG Participants for use in MPOG or ASPIRE Projects. Participant is responsible for ensuring the removal of all prohibited direct identifiers from the Participant Data, such that the Participant Data will be in the form of a Limited Data Set, before transfer to Michigan. 2. That Participant has the authority and hereby grants Michigan, as the coordinating center, explicit permission to: a. Process and use Participant Data for MPOG activities; and b. Distribute the Participant Data, as part of MPOG Data, to MPOG Participants upon submission by such MPOG Participants of a MPOG Project or ASPIRE Project. 3. To not use or disclose MPOG Data other than as permitted or required by the Agreement or as Required by Law, and shall not use or disclose the MPOG Data in a manner inconsistent with the Privacy Rule. 4. To not use MPOG Data in any research or quality improvement initiative that is not approved as part of the Project, and for a period not to exceed the period of time identified in the Project. Modification of an approved Project requires submission of a Project amendment to, and approval by, the Perioperative Clinical Research Committee (PCRC). 5. To establish appropriate administrative, technical, procedural, and physical safeguards to protect the confidentiality of the MPOG Data and to prevent loss, unauthorized access or use, modification or disclosure, and any misuse of the MPOG Data. 6. To ensure that any agents, including subcontractors, or other third parties to whom it provides MPOG Data which is received from, or created or received by Participant agrees in writing to be bound by the same restrictions and conditions that apply through this Agreement to Participant with respect to such MPOG Data. 7. To report to Michigan any use or disclosure of MPOG Data not provided for by this Agreement of which the Participant, its officers, employees, or agents become aware, including without limitation, any disclosure of MPOG Data to an unauthorized subcontractor, within five (5) working days of its discovery, and agrees to mitigate to the extent practicable any harmful effect that is known to Participant of any such use or disclosure. 8. To not identify, attempt to identify, or contact any Individual, or living relative of an Individual, from which the MPOG Data was derived, including through the use of other outside databases or the performance of mathematical or statistical techniques to identify Individuals. 9. To submit a proposed manuscript to the PCRC prior to submission to academic journals for approval. PCRC submission is to ensure that the previously approved PCRC research hypothesis is addressed and answered and the MPOG Data was used as initially approved. Participant will submit the proposed manuscript within nine (9) months of the Participant receiving the MPOG Data. 10. To acknowledge that other researchers may have access to MPOG data sets and that overlap of research is a distinct possibility. 11. To review the most current version of the MPOG Bylaws and evidence Participant’s understanding by signing the MPOG Bylaws.

Participant Obligations. Participant agrees: 1. To provide Participant Data, as applicable, to Michigan, in accordance with frequency, data, and upload specification to be provided by the coordinating center, for the sole and limited purpose of enabling Michigan to receive, process, use, and distribute the Participant Data to MPOG Participants for use in MPOG or ASPIRE Projects. Participant is responsible for ensuring the removal of all prohibited direct identifiers from the Participant Data, such that the Participant Data will be in the form of a Limited Data Set, before transfer to Michigan. 2. That Participant has the authority and hereby grants Michigan, as the coordinating center, explicit permission to: a. Process and use Participant Data for MPOG activities; and b. Distribute the Participant Data, as part of MPOG Data, to MPOG Participants upon submission by such MPOG Participants of a MPOG Project or ASPIRE Projectstudy that has been reviewed and approved by the PCRC. 3. To not use or disclose MPOG Data other than as permitted or required by the Agreement or as Required required by Lawlaw, and shall not use or disclose the MPOG Data in a manner inconsistent with that will compromise the Privacy Ruleprivacy of any Individual or the confidentiality of the MPOG Data. 4. To not use MPOG Data in any research or quality improvement initiative that is not approved as part of the Project, and for a period not to exceed the period of time identified in the Project. Modification of an approved Project requires submission of a Project amendment to, and approval by, the Perioperative Clinical Research Committee (PCRC). 5. To establish appropriate administrative, technical, procedural, and physical safeguards to protect the confidentiality of the MPOG Data and to prevent loss, unauthorized access or use, modification or disclosure, and any misuse of the MPOG Data. 6. To ensure that any agents, including subcontractors, or other third parties to whom it provides MPOG Data which is received from, or created or received by Participant on behalf of, Michigan agrees in writing to be bound by the same restrictions and conditions that apply through this Agreement to Participant with respect to such MPOG Data. 7. To report to Michigan any use or disclosure of MPOG Data not provided for by this Agreement of which the Participant, its officers, employees, or agents become aware, including without limitation, any disclosure of MPOG Data to an unauthorized subcontractor, within five (5) working days of its discovery, and agrees to mitigate to the extent practicable any harmful effect that is known to Participant of any such use or disclosure. 8. To not identify, attempt to identify, or contact any Individual, or living relative of an Individual, from which the MPOG Data was derived, including through the use of other outside databases or the performance of mathematical or statistical techniques to identify Individuals. 9. To submit a proposed manuscript to the PCRC prior to submission to academic journals for approval. PCRC submission is to ensure that the previously approved PCRC research hypothesis is addressed and answered and the MPOG Data was used as initially approved. Participant will submit the proposed manuscript within nine (9) months of the Participant receiving the MPOG Data. 10. To acknowledge that other researchers may have access to MPOG data sets and that overlap of research is a distinct possibility. 11. To review the most current version of the MPOG Bylaws and evidence Participant’s understanding by signing the MPOG Bylaws.

Participant Obligations. Participant agrees: 1. To provide Participant Data, as applicable, to Michigan, in accordance with frequency, data, and upload specification to be provided by the coordinating center, for the sole and limited purpose of enabling Michigan to receive, process, use, and distribute the Participant Data to MPOG SOURCE-DC Participants for use in MPOG or ASPIRE SOURCE-DC Projects. Participant is responsible for ensuring the removal of all prohibited direct identifiers from the Participant Data, such that the de-identifying and coding Participant Data will be in the form of a Limited Data Set, before transfer to Michigan. 2. That Participant has the authority and hereby grants Michigan, as the coordinating center, explicit permission to: a. Process and use Participant Data for MPOG SOURCE-DC activities; and b. Distribute the Participant Data, as part of MPOG SOURCE-DC Data, to MPOG SOURCE-DC Participants upon submission by such MPOG SOURCE-DC Participants of a MPOG Project or ASPIRE SOURCE-DC Project. 3. To not use or disclose MPOG SOURCE-DC Data other than as permitted or required by the Agreement or as Required by Law, and shall not use or disclose the MPOG Data in a manner inconsistent with the Privacy Rule. 4. To not use MPOG SOURCE-DC Data in any research or quality improvement initiative that is not approved as part of the Project, and for a period not to exceed the period of time identified in the Project. Modification of an approved Project requires submission of a Project amendment to, and approval by, the Perioperative Clinical Research Committee (PCRCRC). 5. To establish appropriate administrative, technical, procedural, and physical safeguards to protect the confidentiality of the MPOG SOURCE-DC Data and to prevent loss, unauthorized access or use, modification or disclosure, and any misuse of the MPOG SOURCE-DC Data. 6. To ensure that any agents, including subcontractors, or other third parties to whom it provides MPOG SOURCE-DC Data which is received from, or created or received by Participant agrees in writing to be bound by the same restrictions and conditions that apply through this Agreement to Participant with respect to such MPOG SOURCE-DC Data. 7. To report to Michigan any use or disclosure of MPOG SOURCE-DC Data not provided for by this Agreement of which the Participant, its officers, employees, or agents become aware, including without limitation, any disclosure of MPOG SOURCE-DC Data to an unauthorized subcontractor, within five (5) working days of its discovery, and agrees to mitigate to the extent practicable any harmful effect that is known to Participant of any such use or disclosure. 8. To not identify, attempt to identify, or contact any Individual, or living relative of an Individual, from which the MPOG SOURCE-DC Data was derived, including through the use of other outside databases or the performance of mathematical or statistical techniques to identify Individuals. 9. To submit a proposed manuscript to the PCRC RC prior to submission to academic journals for approval. PCRC submission is review by the RC to ensure appropriate attribution to SOURCE and that the previously approved PCRC research hypothesis is addressed and answered and reflects the MPOG Data was used as initially approved. Participant will submit the proposed manuscript within nine (9) months of the Participant receiving the MPOG Dataoriginal project’s proposal. 10. To acknowledge that other researchers may have access to MPOG SOURCE-DC data sets and that overlap of research is a distinct possibility. 11. To review the most current version of the MPOG SOURCE-DC Bylaws and evidence Participant’s understanding by signing the MPOG SOURCE-DC Bylaws. 12. To carry out the tasks described in Exhibit B, Statement of Work-Participant Test Data. 13. Participant may elect to provide additional optional data as described in Exhibits B, C, and D by selecting such options below. To the extent such data is provided, the permissions and obligations of this section C shall extend to those optional data sets as well. If no option is selected, Participant shall only provide Participant Data as defined above. In addition to Participant Data, Participant will provide (check any/all that apply): _____ Participant Test Data as defined in Exhibit B, incorporated herein only if this option is selected. _____ Participant Free-Text Data Set as defined as Exhibit C, incorporated herein only if this option is selected. _____ Participant Consented Data Set as defined in Exhibit D, incorporated herein only if this option is selected. _____ Participant Coded Data as defined in Exhibit E, incorporated herein only if this option is selected.

Participant Obligations. Participant agrees: 1. To provide Participant Data, as applicable, to Michigan, in accordance with frequency, data, and upload specification to be provided by the coordinating center, for the sole and limited purpose of enabling Michigan to receive, process, use, and distribute the Participant Data to MPOG SOURCE-DC Participants for use in MPOG or ASPIRE SOURCE-DC Projects. Participant is responsible for ensuring the removal of all prohibited direct identifiers from the Participant Data, such that the de-identifying and coding Participant Data will be in the form of a Limited Data Set, before transfer to Michigan. 2. That Participant has the authority and hereby grants Michigan, as the coordinating center, explicit permission to: a. Process and use Participant Data for MPOG SOURCE-DC activities; and b. Distribute the Participant Data, as part of MPOG SOURCE-DC Data, to MPOG SOURCE-DC Participants upon submission by such MPOG SOURCE-DC Participants of a MPOG Project or ASPIRE SOURCE-DC Project. 3. To not use or disclose MPOG SOURCE-DC Data other than as permitted or required by the Agreement or as Required by Law, and shall not use or disclose the MPOG Data in a manner inconsistent with the Privacy Rule. 4. To not use MPOG SOURCE-DC Data in any research or quality improvement initiative that is not approved as part of the Project, and for a period not to exceed the period of time identified in the Project. Modification of an approved Project requires submission of a Project amendment to, and approval by, the Perioperative Clinical Research Committee (PCRCRC). 5. To establish appropriate administrative, technical, procedural, and physical safeguards to protect the confidentiality of the MPOG SOURCE-DC Data and to prevent loss, unauthorized access or use, modification or disclosure, and any misuse of the MPOG SOURCE-DC Data. 6. To ensure that any agents, including subcontractors, or other third parties to whom it provides MPOG SOURCE-DC Data which is received from, or created or received by Participant agrees in writing to be bound by the same restrictions and conditions that apply through this Agreement to Participant with respect to such MPOG SOURCE-DC Data. 7. To report to Michigan any use or disclosure of MPOG SOURCE-DC Data not provided for by this Agreement of which the Participant, its officers, employees, or agents become aware, including without limitation, any disclosure of MPOG SOURCE-DC Data to an unauthorized subcontractor, within five (5) working days of its discovery, and agrees to mitigate to the extent practicable any harmful effect that is known to Participant of any such use or disclosure. 8. To not identify, attempt to identify, or contact any Individual, or living relative of an Individual, from which the MPOG SOURCE-DC Data was derived, including through the use of other outside databases or the performance of mathematical or statistical techniques to identify Individuals. 9. To submit a proposed manuscript to the PCRC RC prior to submission to academic journals for approval. PCRC submission is review by the RC to ensure appropriate attribution to SOURCE and that the previously approved PCRC research hypothesis is addressed and answered and reflects the MPOG Data was used as initially approved. Participant will submit the proposed manuscript within nine (9) months of the Participant receiving the MPOG Dataoriginal project’s proposal. 10. To acknowledge that other researchers may have access to MPOG SOURCE-DC data sets and that overlap of research is a distinct possibility. 11. To review the most current version of the MPOG SOURCE-DC Bylaws and evidence Participant’s understanding by signing the MPOG SOURCE-DC Bylaws. 12. To execute Exhibit B, the Datavant Solution Order Form, which provides de-identification and linking for tools for Participant to use related to Participant Data transfer to Michigan.