Appendix2MTA.pdf

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The Cancer Genome Atlas Project (TCGA) Material Transfer and Data Use Agreement

For Transfers to the TCGA Biospecimen Core Resource (BCR) from Tissue Source Sites

This Material Transfer and Data Use Agreement (the “Agreement”) is by and between ______________________________ (“Provider”), and ______________________________ (“Recipient”), regarding the transfer of human specimens and associated data to the Recipient as part of The Cancer Genome Atlas (TCGA) pilot project (the “Project”). Throughout this Agreement, Provider and Recipient are collectively referred to as the “Parties.” This Agreement will become effective upon the date of the last signature affixed below (the “Effective Date”).

WHEREAS, in order to improve the ability to diagnose, treat, and prevent cancer, the National Cancer Institute (“NCI”) and the National Human Genome Research Institute (“NHGRI”), member institutes of the National Institutes of Health, an agency of the federal government, have jointly undertaken the Project as a comprehensive and coordinated research effort to accelerate the understanding of the molecular basis of cancer through the application of genome analysis technologies, including large-scale genome sequencing;

WHEREAS, the major organizational components of the Project includes a TCGA Human Cancer Biospecimen Core Resource (“TCGA BCR”), multiple TCGA Cancer Genome Characterization Centers and TCGA Genome Sequencing Centers, which are third party institutions funded respectively by the NCI and the NHGRI (collectively the “TCGA Centers”), and a TCGA Data Coordination Center (“TCGA DCC”), which is operated by NCI through the NCI Center for Bioinformatics;

WHEREAS, the purpose of utilizing a centralized TCGA BCR is to minimize the variability introduced by the collection, processing and handling of selected human biospecimens and derivative materials that will be studied during the course of the Project;

WHEREAS, Recipient has been selected to act as the TCGA BCR, pursuant____________, and the tasks with which it is charged include receiving and processing human biospecimens, derivative materials and associated data and distributing all of the foregoing to the TCGA Centers and distributing only the associated data to the TCGA DCC; and

WHEREAS, Recipient, desires to receive, process and distribute biospecimens, derivative materials and associated data from the Provider to the TCGA Centers and the TCGA DCC, as appropriate;

WHEREAS, Provider desires to transfer certain human biospecimens, derivative materials, and associated data to Recipient for further distribution to the TCGA Centers and the TCGA DCC, as appropriate;

WHEREAS, the TCGA Centers and the TCGA DCC, pursuant to policies established as part of the Project, may not make a claim for intellectual property rights in the MATERIAL, nor may they make a claim for intellectual property rights in DATA prior to its public availability;

WHEREAS, Provider and Recipient desire to protect the privacy and provide for the security of certain information disclosed to Recipient in compliance with applicable laws and regulations; and

TCGA MTA FORM January 2009

WHEREAS, Provider, if an entity of the United States of America (“U.S.”), may be a covered entity subject to the Health Insurance Portability and Accountability Act of 1996, as amended (“HIPAA”), and, if not a U.S. entity, desires to protect the privacy of certain information disclosed to the Recipient in a manner consistent with HIPAA and the applicable laws of its jurisdiction that are similar in nature;

NOW, THEREFORE, in consideration of the mutual promises in this Agreement and for other good and valuable consideration, the sufficiency of which is hereby acknowledged, the Parties hereby agree as follows:

1. DEFINITIONS. Within this Agreement, the following terms will have the same meaning and effect as those used in the Standards for Privacy of Individually Identifiable Health Information set forth in 45 CFR Parts 160 and 164 (“HIPAA Privacy Rule”). These terms are repeated here for convenience.

(a) Under 45 CFR 160.103 (“Definitions”), a “covered entity” is an organization, individual, institution, or other entity that is subject to the standards, requirements, and implementation specifications of the HIPAA Privacy Rule with respect to protected health information.

(b) Under 45 CFR 164.514 (“Other requirements relating to uses and disclosures of protected health information”), “De-identified” information is information that formerly contained individually identifiable health information but which has had all unique identifying information, numbers, characteristics, and codes removed such that the information a record contains cannot be used alone or in combination with other information to identify the individual who is the subject of the information. Identifying information includes, but is not limited to, the 18 categories of identifiers described in 45 CFR 164.514(b)(2).

(c) Under 45 CFR 164.103 (“Definitions”), “Protected Health Information” or “PHI” means any information, whether oral or recorded in any form or medium: (i) that relates to the past, present, or future physical or mental condition of an individual; the provision of health care to an individual; or the past, present, or future payment for the provision of health care to an individual, and (ii) that identifies the individual or with respect to which there is a reasonable basis to believe the information can be used to identify the individual.

(d) Under 45 CFR 164.514(e)(2) (“Implementation Specification: Limited data set”), a “limited data set” (herein “LDS”) is protected health information that excludes the 16 direct identifiers listed in that section. Any such information that identifies the individual who is the subject of the PHI, his or her relatives, employers, or household members must be removed for the PHI to constitute an LDS.

Unlike de-identified PHI, an LDS may contain postal address information, in the form of a town, city, State, or zip code only; age; specific dates, for example, dates of birth, death, admission, treatment, or release; and any other information, not specifically listed in that section, that could be used alone or in combination with other information to identify a specific individual.

2. DESCRIPTION OF MATERIAL AND DATA.

(a) The material to be transferred (“ORIGINAL MATERIAL”) is a set of human biospecimens described specifically as: ______________________________________________ [insert additional description of biospecimens or refine description]

(b) The data to be transferred to Recipient are clinical, biological, technical and/or other information describing the ORIGINAL MATERIAL (“DATA”). Some of the DATA may be Protected Health Information and will be transferred in the form of an LDS.

3. COLLECTION OF MATERIAL AND DATA. The Provider represents and warrants to Recipient that: (a) all ORIGINAL MATERIAL and DATA provided to Recipient by Provider were collected pursuant to and in accordance with a protocol approved by an Institutional Review Board (“IRB”); (b) the IRB’s oversight of the collection of any ORIGINAL MATERIAL and DATA included a review of all necessary informed consents and authorizations, which consents do not prohibit redistribution of the ORIGINAL MATERIAL or materials derived from the ORIGINAL MATERIAL, e.g., DNA and RNA products (“DERIVATIVE MATERIAL,” together with the ORIGINAL MATERIAL, the “MATERIAL”) or DATA in the manner described in Section 4 of this Agreement; (c) the transfer, processing and analysis of the ORIGINAL MATERIAL and DATA, as part of the Project and for the Purpose, is authorized by or consistent with the general principles of the informed consent of the patient supplying such ORIGINAL MATERIAL and DATA, as determined by an IRB; and (d) the collection of the ORIGINAL MATERIAL and DATA was conducted in compliance with all applicable laws, regulations and policies for the protection of human subjects, including, in the case where Provider is a covered entity, 45 CFR Part 46, “Protection of Human Subjects” (the “Common Rule”) and the HIPAA Privacy Rule, and any necessary approvals, authorizations, human subjects assurances, informed consent documents, and IRB approvals were obtained.

4. TRANSFER OF ORIGINAL MATERIAL AND DATA; PURPOSE. (a) Provider agrees to provide to Recipient the ORIGINAL MATERIAL and DATA, in the form of an LDS pursuant to Case Report Forms provided by the Recipient to the Provider, in accordance with applicable laws, regulations and policies, including but not limited to the Common Rule, the HIPAA Privacy Rule, and any necessary authorizations, human subjects assurances, informed consent documents, and IRB approvals. The sole and limited purpose of the Provider’s transfer to Recipient of the DATA is to enable Recipient to receive, process and distribute the MATERIAL and the DATA, in the appropriate form as indicated below, to the TCGA Centers and the TCGA DCC at NCI in fulfillment of its contractual obligations to NCI (the “Purpose”). If Provider is a HIPAA Covered Entity, the Parties expressly intend for this Agreement to constitute a data use agreement, authorizing use and disclosure only in furtherance of the Purpose, in accordance with 45 CFR 164.514(e)(4). Provider is responsible for removing all of the prohibited direct identifiers from the DATA, such that the DATA will be in the form of an LDS, before transfer to Recipient.

(b) Provider has the authority and hereby grants Recipient explicit permission to further distribute the MATERIAL and De-identified DATA to the TCGA Centers.

(c) Provider has the authority and hereby also grants Recipient explicit permission to further distribute the DATA, in the form of an LDS, to the TCGA DCC upon execution by both Recipient and NCI of a data use agreement that is consistent with the requirements of the HIPAA Privacy Rule.

Furthermore, Provider acknowledges and agrees that Recipient may allow the TCGA DCC to provide all or part of the LDS to third parties pursuant to separate data use agreements that are no less restrictive than this Agreement and that prohibit such third parties from further distributing the

LDS.

(d) The Agreement does not restrict the Provider’s right to distribute the MATERIAL and DATA to third parties.

5. RESPONSIBILITIES AND AUTHORIZATIONS OF RECIPIENT

(a) Recipient’s IRB has determined that Recipient’s participation in the Project is exempt from the requirements of 45 CFR 46. Recipient agrees to handle and distribute the MATERIAL in accordance with all applicable laws, regulations and policies, including, as applicable, the Common Rule, the HIPAA Privacy Rule, and any necessary human subject’s assurances, informed consents and IRB approvals.

(b) Recipient further agrees that it will only use and/or disclose the DATA for the Purpose described herein and shall not use or disclose the DATA in a manner inconsistent with the HIPAA Privacy Rule.

(c) Recipient is not authorized and shall not further disclose the DATA other than as permitted by this Agreement or as otherwise required by law. Recipient shall not distribute the DATA to other third parties without written consent from Provider and NCI.

(d) Recipient shall use appropriate administrative, technical, and physical safeguards to prevent use or disclosure of the DATA other than as provided for in this Agreement.

(e) Recipient shall notify Provider in writing within five (5) working days of its discovery of any use or disclosure of the DATA not permitted by this Agreement of which Recipient, its officers, employees, or agents become aware. Recipient shall take (i) prompt corrective action to cure any deficiencies or (ii) any action pertaining to such unauthorized disclosure required by applicable federal law.

(f) Recipient shall ensure that any of its agents or subcontractors agree with Recipient in writing that such agent or subcontractor will hold any DATA transmitted from the Recipient to such agent or subcontractor confidential and will use or disclose the information only for the purpose for which it was used or disclosed to the agent or subcontractor, or as required by law. Additionally, the agent or subcontractor shall notify Recipient of any instances, of which it is aware, in which the DATA has been used or disclosed inconsistent with this Agreement.

(g) Recipient agrees to not identify or contact any donor, or living relative of a donor, who provided the MATERIAL or any DATA received by Recipient under this Agreement from Provider.

Furthermore, Recipient will not attempt to obtain or otherwise acquire any PHI associated with the MATERIAL beyond that which is provided in the DATA by the Provider.

(h) Recipient will retain and abide by this Agreement for as long as it retains the DATA or other PHI received from the Provider, plus 6 (six) years after the date it returns or destroys all such information.

6. BREACH OR VIOLATION. Provider is not responsible for Recipient’s violations of this Agreement, unless Provider knows of a pattern of activity or practice that constitutes a material breach or violation of this Agreement, in which case it must take reasonable steps to cure the breach, end the violation or withhold the LDS or other PHI delivered to Recipient. If this is not possible, the breach will be reported to the Secretary of the Department of Health and Human Services (“DHHS”).

If Recipient is a covered entity as defined by the HIPAA Privacy Rule, Recipient acknowledges that a breach of this Agreement is a violation of the HIPAA Privacy Rule and could subject Recipient to potential fines or imprisonment.

7. THE MATERIAL AND DATA ARE NOT FOR USE IN HUMAN SUBJECTS OR FOR

THE TREATMENT OR DIAGNOSIS OF HUMAN SUBJECTS.

8. DISCLAIMER. Any MATERIAL delivered pursuant to this Agreement is understood to be experimental in nature and may have hazardous properties. SUBJECT TO THE

REPRESENTATIONS IN SECTION 3 ABOVE WITH RESPECT TO THE MATERIAL OR

DATA, PROVIDER MAKES NO REPRESENTATIONS AND EXTENDS NO WARRANTIES OF

ANY KIND, EITHER EXPRESSED OR IMPLIED. THERE ARE NO EXPRESS OR IMPLIED

WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, OR

THAT THE USE OF THE MATERIAL OR DATA WILL NOT INFRINGE ANY PATENT,

COPYRIGHT, TRADEMARK, OR OTHER PROPRIETARY RIGHTS.

9. DISPOSAL OF MATERIAL AND DATA. At the end of contract with the NCI or upon the termination of this Agreement by either Party, Recipient will dispose of the ORIGINAL MATERIAL and DATA in its possession in the manner decided at the sole discretion of NCI Contractor and consistent with law and the informed consent of the individual providing the ORIGINAL MATERIAL. Such disposition may include, but is not limited to, continued storage on behalf of Provider for future research, transfer to the Provider, use in an expansion of the Project, transfer to another organization acting on NCI’s behalf, or destruction. NCI shall be responsible for ensuring that any directive given to the Recipient regarding the disposition of the ORIGINAL MATERIAL and DATA is consistent with the informed consent of the patient who provided such ORIGINAL MATERIAL. Provider acknowledges that any ORIGINAL MATERIAL transferred by Recipient to the TCGA Centers and/or the TCGA DCC may be destroyed as a consequence of the analyses conducted in accordance with the Project.

10. INTELLECTUAL PROPERTY. Provider explicitly retains ownership of ORIGINAL MATERIAL and DATA. Provider acknowledges and agrees that it does not by virtue of this Agreement acquire any intellectual property rights in the future inventions or discoveries made by third parties using the MATERIAL or DATA distributed by Recipient. Recipient acknowledges that it serves only as the custodian of the MATERIAL and DATA, and therefore agrees that it does not by virtue of this Agreement acquire any intellectual property rights in the MATERIAL, nor any future intellectual property rights in any research conducted by third-parties using the MATERIAL or

DATA.

11. GOVERNING LAW. Except for any federal laws referred to in or otherwise applicable to this Agreement, including but not limited to HIPAA, this Agreement will be governed by and interpreted in accordance with the laws of the [State of _______________]without regard to conflicts-of-laws principles that would require the application of any other law.

12. ASSIGNMENT; SUCCESSORS AND ASSIGNS; NO THIRD-PARTY RIGHTS. Recipient may not assign its rights or cause to be assumed its obligations hereunder without the prior written consent of Provider, which consent shall not be unreasonably withheld or delayed. Subject to the foregoing, this Agreement shall apply to, be binding in all respects upon and inure to the benefit of the Parties hereto and their respective successors and assigns. Nothing expressed or referred to in this Agreement shall be construed to give any person or entity other than the Parties hereto any legal or equitable right, remedy or claim under or with respect to this Agreement or any provision of this Agreement.

13. COST. The MATERIAL and DATA are provided at no cost to Recipient.

14. SHIPPING. Provider will notify Recipient when the MATERIAL and DATA are ready for shipment. Recipient will be responsible for the pick-up and shipment, including shipping costs, of the MATERIAL and DATA.

15. ENTIRE AGREEMENT. This Agreement constitutes the entire agreement between the Parties with respect to the subject matter hereof, and supersedes and replaces all prior agreements, understandings, commitments, communications and representations made between the Parties, whether written or oral, with respect to the subject matter hereof. This Agreement may not be amended, supplemented, or otherwise modified except by a written agreement executed by each of the Parties. Either Party has the right to terminate this Agreement at any time with written notice to the other Party.

16. EXECUTION OF AGREEMENT. This Agreement may be executed in two or more counterparts, each of which will be deemed to be an original copy and all of which, when taken together, will be deemed to constitute one and the same agreement. The exchange of copies of the Agreement and of signature pages by facsimile transmission will constitute effective execution and delivery of this Agreement as to the Parties hereto and may be used in lieu of the original Agreement for all purposes. Signatures of the Parties transmitted by facsimile will be deemed to be their original signatures for all purposes.

SIGNATURES ON FOLLOWING PAGE

Signatures for Provider Provider Scientist:

Provider Organization:

Name of Authorized Official:

Title of Authorized Official:

Signature of Authorized Official Date

Certification of Provider Authorized Official: This Agreement __has / __has not been modified. If modified, the modifications are attached.

Signatures for Recipient ___________________

Recipient Organization:

Address:

Name of Authorized Official:

Title of Authorized Official:

Signature of Authorized Official Date

Recipient Scientist:

Certification of Recipient Scientist: I have read and understood the conditions outlined in this Agreement and I agree to abide by them in the receipt and use of the MATERIAL.

Scientist Receiving Material Date

Signatures for Recipient [ ]

Recipient Organization:

Address:

Name of Authorized Official:

Title of Authorized Official:

Signature of Authorized Official Date

Recipient Scientist:

Certification of Recipient Scientist: I have read and understood the conditions outlined in this Agreement and I agree to abide by them in the receipt and use of the MATERIAL.

Scientist Receiving Material Date