Common use of Termination and Violations Clause in Contracts

Termination and Violations. This Data Use Certification will be in effect for a period of one (1) year from the date the dataset(s) are made accessible to the Approved User (“Approved Access Date”). At the end of the access period, Approved Users agree to destroy all copies of the requested dataset(s), except as required by publication practices or law to retain them. Consideration will be given to a renewal of this agreement upon submission of a new DAR. Copies of NIH genomic dataset(s) may not need to be destroyed if, with advance notice and approval by the NHLBI Data Access Committee, the project has been transferred to another Approved User. In this case, documentation must be provided that other Approved Users are using the dataset(s) under an active DAC approved research project at the same institution. The Requester and Approved User acknowledge that the NIH or the NHLBI may terminate this agreement and immediately revoke access to all NIH genomic datasets at any time if the Requester is found to be no longer in agreement with the policies, principles and procedures of the NIH and the NHLBI. ***************************************** By submission of the attached Data Access Request, the Requester through the Institutional Signing Official attests to the Approved Users’ qualifications for access to and use of NIH genomic dataset(s) and certifies their agreement to the NIH principles, policies and procedures for the use of the requested datasets as articulated in this document, including the potential termination of access should a violation of any of these agreement terms be identified. Requesters and the Principal Investigator further acknowledge that they have shared this document and the NIH GWAS data sharing policies and procedures for access and use of genomic datasets with any Approved Users, appropriate research staff, and all other Key Personnel identified in the DAR. Institutional Signing Officials acknowledge that they have considered the relevant NIH GWAS policies and procedures, that they have shared this document and the relevant policies and procedures with appropriate institutional organizations, and have assured compliance with local institutional policies related to technology transfer, information technology, privacy, and human subjects research. Definitions of Terminology Appendix

Termination and Violations. This Data Use Certification will be in effect for a period of one (1) year from the date the dataset(s) are made accessible to the Approved User (“Approved Access Date”). At the end of the access period, Approved Users agree to destroy all copies of the requested dataset(s), except as required by publication practices or law to retain them. Consideration will be given to a renewal of this agreement upon submission of a new DAR. Copies of NIH genomic dataset(s) may not need to be destroyed if, with advance notice and approval by the NHLBI GAIN Data Access Committee, the project has been transferred to another Approved User. In this case, documentation must be provided that other Approved Users are using the dataset(s) under an active DAC approved research project at the same institution. The Requester and Approved User acknowledge that the NIH or the NHLBI GAIN may terminate this agreement and immediately revoke access to all NIH genomic datasets at any time if the Requester is found to be no longer in agreement with the policies, principles and procedures of the NIH and the NHLBIGAIN. ***************************************** By submission of the attached Data Access Request, the Requester through the Institutional Signing Official attests to the Approved Users’ qualifications for access to and use of NIH genomic dataset(s) and certifies their agreement to the NIH principles, policies and procedures for the use of the requested datasets as articulated in this document, including the potential termination of access should a violation of any of these agreement terms be identified. Requesters and the Principal Investigator further acknowledge that they have shared this document and the NIH GWAS data sharing policies and procedures for access and use of genomic datasets with any Approved Users, appropriate research staff, and all other Key Personnel identified in the DAR. Institutional Signing Officials acknowledge that they have considered the relevant NIH GWAS policies and procedures, that they have shared this document and the relevant policies and procedures with appropriate institutional organizations, and have assured compliance with local institutional policies related to technology transfer, information technology, privacy, and human subjects research. Definitions of Terminology Appendix

Termination and Violations. This Data Use Certification agreement will be in effect for a period of one (1) year from the date the dataset(s) are made accessible to the Approved User (“Approved Access Date”). At the end of the access period, Approved Users agree to destroy all copies of the requested dataset(s), except as required by publication practices or law to retain them. Consideration will be given to a renewal of this agreement upon submission of a new DAR. Copies of NIH HeLa genomic dataset(s) may not need to be destroyed if, with advance notice and approval review by the NHLBI HeLa Genome Data Access CommitteeWorking Group, the project has been transferred to another Approved User. In this case, documentation must be provided that other Approved Users are using the dataset(s) under an active DAC approved research project at the same institution. The Requester and Approved User acknowledge that the NIH or the NHLBI Institute may terminate this agreement and immediately revoke access to all NIH genomic datasets at any time if the Requester is found to be no longer in agreement with the policies, principles principles, and procedures of the NIH and the NHLBIInstitute. The HeLa Genome Data Access form and this policy may be updated periodically by the NIH Director following the review of the HeLa Genome Data Access Working Group and the recommendation of the Advisory Committee to the NIH Director. ***************************************** By submission of the attached Data Access RequestDAR, the Requester through the Institutional Signing Official attests to the Approved Users’ qualifications for access to and use of NIH genomic HeLa sequence dataset(s) and certifies their agreement to the NIH principles, policies policies, and procedures for the use of the requested datasets as articulated in this documentdocument and as summarized in the dbGaP Approved User Code of Conduct, including the potential termination of access should a violation of any of these agreement terms be identified. Requesters and the Principal Investigator further acknowledge that they have shared this document document, the dbGaP Approved User Code of Conduct, and the NIH GWAS data sharing policies and procedures for access and use of genomic datasets with any Approved Users, appropriate research staff, and all other Key Personnel identified in the DAR. Institutional Signing Officials acknowledge that they have considered the relevant NIH GWAS policies and procedures, that they have shared this document and the relevant policies and procedures with appropriate institutional organizations, and have assured compliance with local institutional policies related to technology transfer, information technology, privacy, and human subjects research. Definitions of Terminology Appendix

Termination and Violations. This Data Use Certification will be in effect for a period of one (1) year from the date the dataset(s) are made accessible to the Approved User (“Approved Access Date”). At the end of the access period, Approved Users agree to destroy all copies of the requested dataset(s), except as required by publication practices or law to retain them. Consideration will be given to a renewal of this agreement upon submission of a new DAR. Copies of NIH genomic dataset(s) may not need to be destroyed if, with advance notice and approval by the NHLBI Data Access Committee, the project has been transferred to another Approved User. In this case, documentation must be provided that other Approved Users are using the dataset(s) under an active DAC approved research project at the same institution. The Requester and Approved User acknowledge that the NIH or the NHLBI may terminate this agreement and immediately revoke access to all NIH genomic datasets at any time if the Requester is found to be no longer in agreement with the policies, principles and procedures proce dures of the NIH and the NHLBI. ***************************************** By submission of the attached Data Access Request, the Requester through the Institutional Signing Official attests to the Approved Users’ qualifications for access to and use of NIH genomic dataset(s) and certifies their agreement to the NIH principles, policies and procedures for the use of the requested datasets as articulated in this document, including the potential termination of access should a violation of any of these agreement terms be identified. Requesters and the Principal Investigator further acknowledge that they have shared this document and the NIH GWAS data sharing policies and procedures for access and use of genomic datasets with any Approved Users, appropriate research staff, and all other Key Personnel identified in the DAR. Institutional Signing Officials acknowledge that they have considered the relevant NIH GWAS policies and procedures, that they have shared this document and the relevant policies and procedures with appropriate institutional organizations, and have assured compliance complianc e with local institutional policies related to technology transfer, information technology, privacy, and human subjects research. Definitions of Terminology Appendix

Termination and Violations. This Data Use Certification will be in effect for a period of one (1) year from the date the dataset(s) are made accessible to the Approved User (“Approved Access Date”). At the end of the access period, Approved Users agree to destroy all copies of the requested dataset(s), except as required by publication practices or law to retain them. Consideration will be given to a renewal of this agreement upon submission of a new DAR. Copies of NIH genomic dataset(s) may not need to be destroyed if, with advance notice and approval by the NHLBI JAAMH Data Access Committee, the project has been transferred to another Approved User. In this case, documentation must be provided that other Approved Users are using the dataset(s) under an active DAC approved research project at the same institution. The Requester and Approved User acknowledge that the NIH or the NHLBI NIA may terminate this agreement and immediately revoke access to all NIH genomic datasets at any time if the Requester is found to be no longer in agreement with the policies, principles and procedures of the NIH and the NHLBINIA. ***************************************** By submission of the attached Data Access Request, the Requester through the Institutional Signing Official attests to the Approved Users’ qualifications for access to and use of NIH genomic dataset(s) and certifies their agreement to the NIH principles, policies and procedures for the use of the requested datasets as articulated in this documentdocument and as summarized in the dbGaP Approved User Code of Conduct, including the potential termination of access should a violation of any of these agreement terms be identified. Requesters and the Principal Investigator further acknowledge that they have shared this document document, the dbGaP Approved User Code of Conduct, and the NIH GWAS data sharing policies and procedures for access and use of genomic datasets with any Approved Users, appropriate research staff, and all other Key Personnel identified in the DAR. Institutional Signing Officials acknowledge that they have considered the relevant NIH GWAS policies and procedures, that they have shared this document and the relevant policies and procedures with appropriate institutional organizations, and have assured compliance with local institutional policies related to technology transfer, information technology, privacy, and human subjects research. Definitions of Terminology Appendix

Termination and Violations. This Data Use Certification will be in effect for a period of one (1) year from the date the dataset(s) are made accessible to the Approved User (“Approved Access Date”). At the end of the access period, The Qualified Investigator and Approved Users agree to destroy all copies of the requested dataset(s), except as required by publication practices or law to retain them. Consideration will be given to a renewal of this agreement upon submission of a new DAR. Copies of NIH genomic dataset(s) may not need to be destroyed if, with advance notice and approval by the NHLBI Data Access Committee, the project has been transferred to another Approved User. In this case, documentation must be provided that other Approved Users are using the dataset(s) under an active DAC approved research project at the same institution. The Requester and Approved User acknowledge that the CIFASD Consortium, the NIH or the NHLBI NIAAA may terminate this agreement and immediately revoke access to all NIH genomic CIFASD datasets at any time if the Requester Qualified Investigator is found to be no longer in agreement with the policies, principles and procedures of the NIH CIFASD Consortium, the NIAAA, and the NHLBINIH. ***************************************** By submission of the attached Data Access Request, the Requester Qualified Investigator through the Institutional Signing Official Authorized Representative attests to the Approved Users’ qualifications for access to and use of NIH genomic CIFASD dataset(s) and certifies their agreement to the CIFASD and NIH principles, policies policies, and procedures for the use of the requested datasets as articulated in this document, including the potential termination of access should a violation of any of these agreement terms be identified. Requesters and the Principal The Qualified Investigator further acknowledge acknowledges that they have shared this document and the NIH GWAS CIFASD data sharing policies and procedures for access and use of genomic CIFASD datasets with any all Approved Users, appropriate research staff, and all other Key Personnel Collaborators identified in the DAR, and that all Approved Users also agree to comply with all requirements of this document. Institutional Signing Officials Authorized Representatives acknowledge that they have considered the relevant NIH GWAS CIFASD policies and procedures, that they have shared this document and the relevant policies and procedures with appropriate institutional organizations, and have assured compliance with local institutional policies related to technology transfer, information technology, privacy, and human subjects research. Definitions of Terminology AppendixInformation Technology (IT) Director (signature not required): Printed Name Position at Institution Email Qualified Investigator: Printed Name Position at Institution Signature Date Email Authorized Representative: Printed Name Position at Institution Signature Date

Termination and Violations. This Data Use Certification DUC will be in effect for a period of one (1) 1 year from the date the dataset(s) are made accessible to the Approved User (“Approved Access Date”). At the end of the access period, Approved Users agree to report progress, and renew access or close-out the project. Upon project closure-out, Approved Users agree to destroy all copies of the requested dataset(s), except as required by publication practices or law to retain them. Consideration will be given to a renewal of this agreement upon submission of a new DAR. Copies of NIH genomic dataset(s) may not need to be destroyed if, with advance notice and approval by the NHLBI Data Access CommitteeNCI/NHGRI TCGA DAC, the project has been transferred to another Approved UserUser at the same institution. In this case, documentation must be provided that other Approved Users are using the dataset(s) under an active DAC a DAC-approved research project at the same institutionDAR. The Requester and Approved User acknowledge that the NIH or the NHLBI NCI/NHGRI TCGA may terminate this agreement and immediately revoke access to all NIH TCGA genomic datasets at any time if the Requester is found to be no longer in agreement with the policies, principles and procedures of the NIH and the NHLBINCI/NHGRI TCGA DAC. ***************************************** By submission of the attached Data Access RequestDAR, the The Requester through the Institutional Signing Official attests to the Approved Users’ qualifications for access to and use of NIH genomic dataset(s) and certifies their agreement agrees to the NIH principles, policies policies, and procedures for the use of the requested datasets as articulated in this document, including the potential termination of access should a violation of any of these agreement terms be identifiedviolated. Requesters and the Principal Investigator PI further acknowledge that they have shared this document document, and the NIH GWAS data sharing policies Data Sharing Policy, and procedures for access and use of genomic datasets with any Approved Users, appropriate research staff, and all other Key Personnel and collaborators identified in the DAR. Institutional Signing Officials acknowledge that they have considered the relevant NIH GWAS policies and procedures, that they have shared this document and the relevant policies and procedures with appropriate institutional organizationsdepartments, and have assured compliance with local institutional policies related to technology transfer, information technology, privacy, and human subjects research. The Requestor and PI acknowledge that they reviewed and understand the TCGA-specific publication policies as outlined in Section 8. Institutional Signing Officials acknowledge that their institute is solely responsible for the conduct of all individuals who have access to the data under the DAR, including investigators, contractor staff (both on and off-site) and trainees. Appendix Definitions Approved User: A user approved by the relevant Data Access Committee(s) to access one or more datasets for a specified period of Terminology Appendixtime and only for the purposes outlined in the investigator’s approved research use statement. Staff members and trainees under the direct supervision of the Approved User are also Approved Users and must abide by the terms laid out in the Data Use Certificate agreement. Collaborator: An individual who is not under the direct supervision of the principal investigator (PI) (e.g., not a member of the PI’s laboratory) who assists with the PI’s dbGaP research project. Internal collaborators are employees of the Requester and work at the same location/campus as the PI. External collaborators are not employees of the Requester and/or do not work at the same location as the PI, and consequently must be independently approved to access dbGaP data. Contributing Investigator: An investigator who submitted a genomic dataset to an NIH-designated data repository (e.g., dbGaP). Data Access Request (DAR): A request submitted to a Data Access Committee for a specific project specifying the data to which access is sought, the planned research use, and the names of collaborators and the Information Technology Director. The DAR is signed by the investigator requesting the data and her/his Institutional Signing Official. Collaborators and project team members on a request must be from the same institution or organization. Data Derivative: any data including individual-level data or aggregate genomic data that stems from the original dataset deposited (e.g. imputed or annotated data) in NIH-designated data repositories (e.g., dbGaP). Summary information that is expected to be shared through community publication practices in not included in this term. Data Use Agreement (DUC): An agreement between the Approved User, the Requestor, and NIH regarding the terms associated with dbGaP data access and the expectations for use of dbGaP datasets. dbGaP Approved User Code of Conduct: Key principles and practices agreed to by all research investigators requesting access to NIH controlled-access genomic data. The elements within the Code of Conduct reflect the terms of access in the Data Use Certification agreement. Failure to abide by the Code of Conduct may result in revocation of an investigator’s access to any and all approved datasets. (See xxxxx://xxxxx.xxxx.xxx.xxx.xxx/aa/GWAS_Code_of_Conduct.html) Information Technology (IT) Director: Individual with the necessary expertise and authority to vouch for the IT capacities at an academic institution, company, or other research entity and the ability of that institution to comply with NIH data security expectations. The IT Director is to be included as key personnel in the Data Access Request. Institutional Certification: Certification by the Institution that delineates, among other items, the appropriate research uses of the data and the uses that are specifically excluded by the relevant informed consent documents. (See xxxx://xxxxxx.xxx.xxx/grants/guide/notice-files/NOT-OD-07-088.html ) Institutional Signing Official: Generally, a senior official at an institution with the authority to sign on behalf of the submitting investigator or an investigator who has submitted a Data Access Request or Project Request to NIH, authorized to enter their institution into a legally binding contract, and who is credentialed through the eRA Commons system. Progress Update: Information included with the annual Data Access Request (DAR) renewal or close-out summarizing the analysis of dbGaP datasets obtained through the DAR and any publications and presentations derived from the work.

Termination and Violations. This Data Use Certification will be in effect for a period of one (1) year from the date the dataset(s) are made accessible to the Approved User (“Approved Access Date”). At the end of the access period, Approved Users agree to destroy all copies of the requested dataset(s), except as required by publication practices or law to retain them. Consideration will be given to a renewal of this agreement upon submission of a new DAR. Copies of NIH genomic dataset(s) may not need to be destroyed if, with advance notice and approval by the NHLBI Data Access Committee, the project has been transferred to another Approved User. In this case, documentation must be provided that other Approved Users are using the dataset(s) under an active DAC approved research project at the same institution. The Requester and Approved User acknowledge that the NIH or the NHLBI may terminate this agreement and immediately revoke access to all NIH genomic datasets at any time if the Requester is found to be no longer in agreement with the policies, principles and procedures of the NIH and the NHLBI. ***************************************** By submission of the attached Data Access Request, the Requester through the Institutional Signing Official attests to the Approved Users’ qualifications for access to and use of NIH genomic dataset(s) and certifies their agreement to the NIH principles, policies and procedures for the use of the requested datasets as articulated in this documentdocument and as summarized in the dbGaP Approved User Code of Conduct, including the potential termination of access should a violation of any of these agreement terms be identified. Requesters and the Principal Investigator further acknowledge that they have shared this document document, the dbGaP Approved User Code of Conduct, and the NIH GWAS data sharing policies and procedures for access and use of genomic datasets with any Approved Users, appropriate research staff, and all other Key Personnel identified in the DAR. Institutional Signing Officials acknowledge that they have considered the relevant NIH GWAS policies and procedures, that they have shared this document and the relevant policies and procedures with appropriate institutional organizations, and have assured compliance with local institutional policies related to technology transfer, information technology, privacy, and human subjects research. Definitions of Terminology Appendix

Termination and Violations. This Data Use Certification will be in effect for a period of one (1) year from the date the dataset(s) are made accessible to the Approved User (“Approved Access Date”). At the end of the access periodUpon project close-out, all Approved Users agree to destroy all copies copies, versions, and derivations of the requested dataset(s)) retrieved from NIH-designated controlled-access databases, on both local servers and hardware, virtual and physical machines, databases, and random-access archives, except as required by publication practices practices, institutional policies, or law to retain them. Consideration will be given to a renewal of this agreement upon submission of a new DAR. Copies of NIH genomic dataset(s) may not need to be destroyed if, with advance notice and approval by the NHLBI Data Access Committee, the project has been transferred to another Approved User. In this case, documentation must be provided that other Approved Users are using the dataset(s) under an active DAC approved research project at the same institution. The Requester and Approved User PI acknowledge that the NIH or the NHLBI NIDCR, or the FaceBase Consortium may terminate this agreement and immediately revoke access to all NIH genomic FaceBase datasets subject to the GDS Policy at any time if the Requester is found to be no longer in agreement with the policies, principles and procedures of the NIH NIH, the NIDCR, and the NHLBIFaceBase Consortium. ***************************************** By submission of the attached Data Access Request, the Requester through the Institutional Signing Official attests to the Approved Users’ qualifications for access to and use of NIH genomic FaceBase dataset(s) and certifies their agreement to the FaceBase and NIH principles, policies policies, and procedures for the use of the requested datasets as articulated in this document, including the potential termination of access should a violation of any of these agreement terms be identified. Requesters and the Principal Investigator further acknowledge that they have shared this document and the NIH GWAS FaceBase data sharing policies and procedures for access and use of genomic FaceBase datasets with any Approved Users, appropriate research staff, and all other Key Personnel Collaborators identified in the DAR. The Institutional Signing Officials acknowledge Official acknowledges that they have considered the relevant NIH GWAS FaceBase policies and procedures, that they have shared this document and the relevant policies and procedures with appropriate institutional organizations, organizations and have assured compliance with local institutional policies related to technology transfer, information technology, privacy, and human subjects research. Definitions Information Technology (IT) Director: Printed Name _ Position at Institution _ Signature _ Date _ Principal Investigator: Printed Name _ Position at Institution _ Signature _ Date _ Institutional Signing Official: Printed Name _ Position at Institution _ Signature _ Date _ APPENDIX DEFINITIONS Approved User: A user approved by the FaceBase Data Access Committee to access one or more datasets for a specified period of Terminology Appendixtime and only for the purposes outlined in the Principal Investigator (PI)’s approved Research Use Statement. The Information Technology (IT) Director indicated on the Data Access Request, as well as any staff members and trainees under the direct supervision of the PI are also Approved Users and must abide by the terms laid out in the Data Use Certificate Agreement. Collaborator: An individual who is not under the direct supervision of the PI (e.g., not a member of the PI’s laboratory) who assists with the PI’s research project involving FaceBase data. Internal collaborators are employees of the Requester and work at the same location/campus as the PI. External collaborators are not employees of the Requester and/or do not work at the same location as the PI, and consequently must be independently approved to access FaceBase data. Contributing Investigator: An investigator who submitted a genomic dataset to FaceBase. Data Access Request (DAR): A request submitted to a Data Access Committee for a specific “consent group” specifying the data to which access is sought, the planned research use, and the names of collaborators and the IT Director. The DAR is signed by the PI requesting the data and her/his Institutional Signing Official. Collaborators and project team members on a request must be from the same institution or organization. Data Use Certification Agreement (DUC): An agreement between the Approved Users, the Requester, and NIH regarding the terms associated with access of controlled-access datasets subject to the GDS Policy and the expectations for use of these datasets.

Termination and Violations. This Data Use Certification DUA will be in effect for a period of one (1) 1 year from the date the dataset(s) are made accessible to the Approved User PI (“Approved Access Date”). At the end of the access period, PIs agree to report progress, and renew access or close-out the project. Upon project closure-out, all Approved Users agree to destroy all copies of the requested dataset(s), except as required by publication practices or law to retain them. Consideration will be given to a renewal of this agreement upon submission of a new DAR. Copies of NIH genomic dataset(s) may not need to be destroyed if, with advance notice and approval by the NHLBI Data Access CommitteeWDMAC, the project has been transferred to another Approved UserUser at the same institution. In this case, documentation must be provided that other Approved Users are using the dataset(s) under an active DAC approved research project at the same institutionWIHS Concept Sheet. The Requester and Approved User PI acknowledge that the NIH or the NHLBI WIHS may terminate this agreement and immediately revoke access to all NIH WIHS genomic datasets at any time if the Requester is found to be no longer in agreement with the policies, principles and procedures of the NIH and the NHLBIWIHS. ***************************************** By submission of the attached Data Access Request, the BY SUBMISSION OF THE GENOMIC DATA USE AGREEMENT (DUA): The Requester through the Institutional Signing Official WIHS PI/Contact attests to the Approved Users’ Concept Sheet PI’s qualifications for access to and use of NIH WIHS genomic dataset(s) and certifies their agreement agrees to the NIH and WIHS principles, policies policies, and procedures for the use of the requested datasets as articulated in this documentdocument and as summarized in the WIHS Concept Sheet and Data Use Agreement, including the potential termination of access should a violation of any of these agreement terms be identifiedviolated. Requesters and the Principal Investigator PI further acknowledge that they have shared this document document, the WIHS Approved User Code of Conduct, and the NIH GWAS data sharing policies WIHS Genomics Data Sharing Policy, and procedures for access and use of genomic datasets with any Approved Users, appropriate research staff, and all other Key Personnel and collaborators identified in the DARWIHS Concept Sheet. Institutional Signing Officials acknowledge WIHS PI/Contact acknowledges that they have considered the relevant NIH GWAS and WIHS data sharing policies and procedures, that they have shared this document and the relevant policies and procedures with appropriate institutional organizationsdepartments, and have assured compliance with local institutional policies related to technology transfer, information technology, privacy, and human subjects research. Definitions WIHS PI/Contact also acknowledges that their institute is solely responsible for the conduct of Terminology Appendixall individuals who have access to the data under the WIHS Concept Sheet, including investigators, contractor staff (both on and off-site) and trainees, as specified in the WIHS Data Use Agreement (DUA). WIHS Readme Project title Printed Name and Title: [Lead Investigator] [WIHS Site PI or WIHS Affiliate] Signature Date Contact Information: Address: Phone: Fax: Email: APPENDIX 1: DEFINITIONS Approved User: A user approved by the WIHS to access one or more datasets for a specified period of time and only for the purposes outlined in the PI’s approved research use statement. Staff members and trainees under the direct supervision of the PI are also Approved Users and must abide by the terms laid out in the Data Use Contract agreement.

Termination and Violations. This Data Use Certification Agreement will be in effect for a period of one (1) year from the date the dataset(s) are made accessible to the Approved User (“Approved Access Date”). At the end of the access period, Approved Users agree to destroy all copies of the requested dataset(s), except as required by publication practices or law to retain them. Consideration will be given to a renewal of this agreement upon submission of a new DAR. Copies of NIH genomic NINDS PDBP dataset(s) may not need to be destroyed if, with advance notice and approval by the NHLBI NINDS Data Access Committee, the project has been transferred to another Approved User. In this case, documentation must be provided that other Approved Users are using the dataset(s) under an active DAC approved research project at the same institution. The Requester and Approved User acknowledge that the NIH or the NHLBI NINDS may terminate this agreement and immediately revoke access to all NIH genomic NINDS PDBP datasets at any time if the Requester is found to be no longer in agreement with the policies, principles and procedures of the NIH and the NHLBININDS. ***************************************** By submission of the attached Data Access RequestRequest and this Data Use Agreement, the Requester through the Institutional Signing Official attests to the Approved Users’ qualifications for access to and use of NIH genomic NINDS PDBP dataset(s) and certifies their agreement to the NIH principles, policies and procedures for the use of the requested datasets as articulated in this documentdocument and as summarized in the PDBP DMR Approved User Code of Conduct, including the potential termination of access should a violation of any of these agreement terms be identified. Requesters and the Principal Investigator further acknowledge that they have shared this document document, the PDBP DMR Approved User Code of Conduct, and the NIH GWAS NINDS PDBP data sharing policies and procedures for access and use of genomic PDBP datasets with any Approved Users, appropriate research staff, and all other Key Personnel identified in the DAR. Institutional Signing Officials acknowledge that they have considered the relevant NIH GWAS NINDS PDBP policies and procedures, that they have shared this document and the relevant policies and procedures with appropriate institutional organizations, and have assured compliance with local institutional policies related to technology transfer, information technology, privacy, and human subjects research. Definitions of Terminology Appendix

Termination and Violations. This Data Use Certification DUC will be in effect for a period of one (1) 1 year from the date the dataset(s) are made accessible to the Approved User (“Approved Access Date”). At the end of the access period, Approved Users agree to report progress, and renew access or close-out the project. Upon project closure-out, Approved Users agree to destroy all copies of the requested dataset(s), except as required by publication practices or law to retain them. Consideration will be given to a renewal of this agreement upon submission of a new DAR. Copies of NIH genomic dataset(s) may not need to be destroyed if, with advance notice and approval by the NHLBI Data Access CommitteeNCI/NHGRI TCGA DAC, the project has been transferred to another Approved UserUser at the same institution. In this case, documentation must be provided that other Approved Users are using the dataset(s) under an active DAC a DAC-approved research project at the same institutionDAR. The Requester and Approved User acknowledge that the NIH or the NHLBI NCI/NHGRI TCGA may terminate this agreement and immediately revoke access to all NIH TCGA genomic datasets at any time if the Requester is found to be no longer in agreement with the policies, principles and procedures of the NIH and the NHLBINCI/NHGRI TCGA DAC. ***************************************** By submission of the attached Data Access RequestDAR, the The Requester through the Institutional Signing Official attests to the Approved Users’ qualifications for access to and use of NIH genomic dataset(s) and certifies their agreement agrees to the NIH principles, policies policies, and procedures for the use of the requested datasets as articulated in this document, including the potential termination of access should a violation of any of these agreement terms be identifiedviolated. Requesters and the Principal Investigator PI further acknowledge that they have shared this document document, and the NIH GWAS data sharing policies Data Sharing Policy, and procedures for access and use of genomic datasets with any Approved Users, appropriate research staff, and all other Key Personnel and collaborators identified in the DAR. Institutional Signing Officials acknowledge that they have considered the relevant NIH GWAS policies and procedures, that they have shared this document and the relevant policies and procedures with appropriate institutional organizationsdepartments, and have assured compliance with local institutional policies related to technology transfer, information technology, privacy, and human subjects research. Definitions The Requestor and PI acknowledge that they reviewed and understand the TCGA-specific publication policies as outlined in Section 8. Institutional Signing Officials acknowledge that their institute is solely responsible for the conduct of Terminology Appendixall individuals who have access to the data under the DAR, including investigators, contractor staff (both on and off-site) and trainees. APPENDIX DEFINITIONS Approved User: A user approved by the relevant Data Access Committee(s) to access one or more datasets for a specified period of time and only for the purposes outlined in the investigator’s approved research use statement. Staff members and trainees under the direct supervision of the Approved User are also Approved Users and must abide by the terms laid out in the Data Use Certificate agreement. Collaborator: An individual who is not under the direct supervision of the principal investigator (PI) (e.g., not a member of the PI’s laboratory) who assists with the PI’s dbGaP research project. Internal collaborators are employees of the Requester and work at the same location/campus as the PI. External collaborators are not employees of the Requester and/or do not work at the same location as the PI, and consequently must be independently approved to access dbGaP data. Contributing Investigator: An investigator who submitted a genomic dataset to an NIH-designated data repository (e.g., dbGaP). Data Access Request (DAR): A request submitted to a Data Access Committee for a specific project specifying the data to which access is sought, the planned research use, and the names of collaborators and the Information Technology Director. The DAR is signed by the investigator requesting the data and her/his Institutional Signing Official. Collaborators and project team members on a request must be from the same institution or organization. Data Derivative: any data including individual-level data or aggregate genomic data that stems from the original dataset deposited (e.g. imputed or annotated data) in NIH-designated data repositories (e.g., dbGaP). Summary information that is expected to be shared through community publication practices in not included in this term. Data Use Agreement (DUC): An agreement between the Approved User, the Requestor, and NIH regarding the terms associated with dbGaP data access and the expectations for use of dbGaP datasets. dbGaP Approved User Code of Conduct: Key principles and practices agreed to by all research investigators requesting access to NIH controlled-access genomic data. The elements within the Code of Conduct reflect the terms of access in the Data Use Certification agreement. Failure to abide by the Code of Conduct may result in revocation of an investigator’s access to any and all approved datasets. (See xxxxx://xxxxx.xxxx.xxx.xxx.xxx/aa/GWAS_Code_of_Conduct.html) Information Technology (IT) Director: Individual with the necessary expertise and authority to vouch for the IT capacities at an academic institution, company, or other research entity and the ability of that institution to comply with NIH data security expectations. The IT Director is to be included as key personnel in the Data Access Request. Institutional Certification: Certification by the Institution that delineates, among other items, the appropriate research uses of the data and the uses that are specifically excluded by the relevant informed consent documents. (See xxxx://xxxxxx.xxx.xxx/grants/guide/notice-files/NOT-OD-07-088.html ) Institutional Signing Official: Generally, a senior official at an institution with the authority to sign on behalf of the submitting investigator or an investigator who has submitted a Data Access Request or Project Request to NIH, authorized to enter their institution into a legally binding contract, and who is credentialed through the eRA Commons system. Progress Update: Information included with the annual Data Access Request (DAR) renewal or close-out summarizing the analysis of dbGaP datasets obtained through the DAR and any publications and presentations derived from the work.

Termination and Violations. This Data Use Certification will be in effect for a period of one (1) year from the date the dataset(s) are made accessible to the Approved User (“Approved Access Date”). At the end of the access period, Approved Users agree to destroy all copies of the requested dataset(s), except as required by publication practices or law to retain them. Consideration will be given to a renewal of this agreement upon submission of a new DAR. Copies of NIH genomic dataset(s) may not need to be destroyed if, with advance notice and approval by the NHLBI Data Access Committee, the project has been transferred to another Approved User. In this case, documentation must be provided that other Approved Users are using the dataset(s) under an active DAC approved research project at the same institution. The Requester and Approved User acknowledge that the NIH or the NHLBI may terminate this agreement and immediately revoke access to all NIH genomic datasets at any time if the Requester is found to be no longer in agreement with the policies, principles and procedures of the NIH and the NHLBI. ***************************************** By submission of the attached Data Access Request, the Requester through the Institutional Signing Official attests to the Approved Users’ qualifications for access to and use of NIH genomic dataset(s) and certifies their agreement to the NIH principles, policies and procedures for the use of the requested datasets as articulated in this documentdocument and as summarized in the dbGaP Approved User Code of Conduct, including the potential termination of access should a violation of any of these agreement terms be identified. Requesters and the Principal Investigator further acknowledge that they have shared this document document, the dbGaP Approved User Code of Conduct, and the NIH GWAS data sharing policies and procedures for access and use of genomic datasets with any Approved Users, appropriate research staff, and all other Key Personnel identified in the DAR. Institutional Signing Officials acknowledge that they have considered the relevant NIH GWAS policies and procedures, that they have shared this document and the relevant policies and procedures with appropriate institutional organizations, and have assured compliance with local institutional policies related to technology transfer, information technology, privacy, and human subjects research. Definitions of Terminology Appendix