DATA PROVIDER AGREEMENT

Version: 05-Jun-2023

This Data Provider Agreement (“DPA”) is effective after developing a Researcher account (the “Effective Date”) by and between Geno.Me Incorporated (“Geno.Me”) and Geno.Me users (“Customer”) pursuant to the Health Insurance Portability and Accountability Act (“HIPAA”), as amended, and related privacy, security, breach notification, and enforcement regulations defined at 45 C.F.R. Parts 160 and 164 (“HIPAA Rules”).

RECITALS

A.   The parties intend for this DPA to:

 

i.      support Geno.Me in disclosing the patient clinical summary Limited Data Set as defined under the HIPAA Rules (the “Disclosed Limited Data Set”) to Data Recipient solely for the purposes of research the “Specified Data Recipient Program”); and

 

ii.    ensure that Customer implements and maintains appropriate safeguards and uses the Disclosed Limited Data Set only for permitted purposes, pursuant to this DPA and the HIPAA Rules.

 

B.    Capitalized terms used and not otherwise defined in this DPA shall have the meanings set forth in the HIPAA Rules.

NOW, THEREFORE, in consideration of the premises and the mutual promises and covenants contained herein, the parties agree as follows:

1.              Data Disclosure and Use.

1.1           Permitted Data Use. Customer must only receive or use the Disclosed Limited Data Set for purposes of the Specified Data Recipient Program as set forth in the preamble and cannot otherwise use or disclose the Disclosed Limited Data Set unless required by law or authorized by Geno.Me in writing.

1.2           Safeguards. Customer must use appropriate safeguards as defined under the HIPAA Rules and related Department of Health and Human Services guidance to prevent any use or disclosure of the Disclosed Limited Data Set other than as provided for by this DPA.

1.3           Reporting Unauthorized Use or Disclosure. Customer must immediately report to Geno.Me any use or disclosure of the Disclosed Limited Data Set not provided for by this DPA of which it becomes aware. Customer must report any unauthorized use or disclosure of the Disclosed Limited Data Set by written notice to Geno.Me at support@yourgeno.me.

1.4           Customer Agents. Customer must not disclose the Disclosed Limited Data Set to any third party, including any agent or contractor, without Geno.Me's prior written consent. Customer must ensure that any agents or other third parties to whom it discloses the Disclosed Limited Data Set each agree to the same restrictions and conditions that apply to Customer regarding the Disclosed Limited Data Set.

1.5           No Identification of Individuals. Customer must not attempt to identify or contact any specific individual whose information appears in the Disclosed Limited Data Set.

1.6           Retention and Destruction. Customer must retain the Disclosed Limited Data Set only for the reasonable duration of the Specified Data Recipient Program, unless otherwise authorized by Geno.Me in writing. Customer will promptly and securely destroy the Disclosed Limited Data Set, using industry-accepted methods, on termination of this DPA or completion of the Specified Data Recipient Program, whichever occurs first, and promptly provide Geno.Me with a written certification of such destruction.

1.7           Audits. Customer will allow Geno.Me to verify compliance with the terms of this DPA.

1.8           Derived Works and Publication. Customer must provide Geno.Me with a copy of any results, reports, or other outputs derived from the Disclosed Limited Data Set. Customer must provide Geno.Me with a reasonable opportunity to approve any reports or other publications derived from the Disclosed Limited Data Set prior to distributing such materials outside Customer, including for purposes of, but not limited to, any peer review, submission to any federal or state agency, demonstration, presentation of findings, synopsis of research, or publication. The retention and destruction requirements in Section 1.6 (Retention and Destruction) apply to any Disclosed Limited Data Set data contained in derived works.

2.              Term and Termination. This DPA and Customer's authorization to use or retain Disclosed Limited Data Set will remain in effect from the Effective Date until terminated. Either party may terminate this DPA at any time, with or without cause, by providing thirty (30) days written notice to the other party. The terms of this DPA shall remain effective in their entirety until Geno.Me receives the certificate of data destruction as set forth in Section 1.6 (Retention and Destruction). Section 5 (Indemnification) shall survive the termination of this DPA.

3.              Compensation. Customer shall pay Geno.Me a fee for the Disclosed Limited Data Set (“Fee”). The Fee shall be payable upon purchase of the dataset.

4.              Ownership. Geno.Me grants to Customer a non-exclusive license for use of the Disclosed Limited Data Set during the term of this Agreement. Customer acknowledges that the right to use the Disclosed Limited Data Set is conditioned upon payment of all fees due and return of this signed agreement to Geno.Me. Customer agrees to comply with applicable HIPAA provisions and regulations and to also use its best efforts, consistent with the practices and procedures Customer takes to protect its own most valuable proprietary information and materials and will take all reasonable steps to protect the Disclosed Limited Data Set and any pertinent documentation and associated trade secrets against any unauthorized use, reproduction, disclosure, or distribution.

5.              Indemnification. Customer shall indemnify, defend, and hold harmless Geno.Me, Geno.Me's subsidiaries or affiliates, and their respective trustees, directors, officers, grantors, employees, agents, and contractors from any claims, losses, damages, expenses, civil monetary penalties, and costs (including attorneys' and court fees and expenses) arising out of or related to (a) any breach of this DPA by Customer or its agents or contractors, including any Breach or alleged Breach of Unsecured Protected Health Information, or (b) any negligence or wrongful acts or omissions by Customer or its agents or contractors, including without limitation, failure to perform Customer's obligations under this DPA, the HIPAA Rules, or other applicable federal, state, or local laws.

6.              Amendment. The parties will cooperate to amend this DPA as necessary from time to time to reflect changes in circumstances or applicable law, including HIPAA and the HIPAA Rules. All amendments to this DPA must be in writing and signed by both parties.

7.              Other Provisions.

7.1           Assignment. This DPA shall be binding on the successors and assigns of Geno.Me and Customer. However, Customer may not assign this DPA, in whole or in part, without Geno.Me's written consent. Any attempted assignment in violation of this provision shall be null and void.

7.2           Counterparts. The parties may execute this DPA in counterparts, all of which together shall constitute one agreement.

7.3           Entire Agreement and Severability. This DPA is the complete agreement between the parties and supersedes all previous agreements or representations, written or oral, regarding the Disclosed Limited Data Set and any related matters as addressed in this DPA. If any part of this DPA is held to be unenforceable, the remainder shall continue in effect.

7.4           Independent Contractors. The relationship between the parties is that of independent contractors. This DPA does not create any agency, joint venture, or partnership relationship between the parties.

7.5           Interpretation. Any ambiguity in this DPA shall be resolved in favor of a meaning that permits the parties to comply with applicable law, including HIPAA and the HIPAA Rules.

7.6           No Third-Party Beneficiaries. Nothing express or implied in this DPA is intended to or shall confer any rights, remedies, obligations, or liabilities on any person other than the parties and their respective successors or assigns.

7.7           Notices. Any notices required or permitted under this DPA must be in writing and sent by United States mail, electronic mail with written acknowledgement of receipt, overnight delivery service, or facsimile transmission to the addresses for each party provided below or such different addresses as a party may later designate in writing. Notices regarding the unauthorized use or disclosure of the Disclosed Limited Data Set must follow the specific requirements listed in Section 1.3 (Reporting Unauthorized Use or Disclosure).

7.8           Regulatory References and Compliance with Laws. A reference in this DPA to the HIPAA Rules or any other applicable law means the section as in effect or as amended, and with which Geno.Me, or Customer must comply. Each party represents and warrants that it shall comply with applicable law, including HIPAA and the HIPAA Rules, in the performance of this DPA.

7.9           Use of Name and Trademarks. Customer shall not use the name(s) or trademark(s) of Geno.Me in any advertising, publicity, endorsement, promotion, or other publicly available document without Geno.Me's prior written consent.

7.10        Waiver. Neither party's delay or omission in exercising any right or remedy under this DPA will constitute waiver or prevent the applicable party's ability to exercise any right or remedy in the future.

7.11        Governing Law. This Agreement shall be governed by the laws of the State of Wisconsin. Venue for any claim, action, or suit, whether state of federal, between Geno.Me and Data Provider shall be Dane County, Wisconsin.

 

By acknowledging this Agreement, the Customer provides assurance that its relevant institutional policies and applicable federal, state, or local laws and regulations (if any) have been followed, including the completion of any IRB review or approval that may be required prior to the Customer’s provision of the Data. Upon the Provider’s written request to the Customer’s Contact for Formal Notices identified in the signature block of this Agreement, the Customer will provide documentation of its IRB approved Protocol.