Last updated: April 8, 2024
These terms and conditions set forth below shall be incorporated into the Practice Services Agreement Cover Sheet between SiteRx, Inc. and its Affiliates (collectively “SiteRx”) and Practice (the “Cover Sheet,” and together, the “Agreement”). Capitalized terms not defined here shall have the meanings assigned to them on the Cover Sheet. The Agreement is effective as of the Effective Date on the Cover Sheet.
1. Definitions.
2. Access to and Use of Platform.
3. SiteRx Obligations.
4. Practice Obligations; Instructions.
5. Termination.
6. Sole Similar Relationship.
Nothing in this Agreement or in this Section shall be interpreted as precluding the Practice from performing its health care functions and offering clinical research opportunities to its patients without relying on the Platform or any similar products or services, or from matching patients to clinical research opportunities that are not made available through the Platform. The Practice agrees that during the term of this Agreement and for six (6) months after its termination for any reason, SiteRx shall be the exclusive corporate recipient of services similar to the Practice Services, as provided by Practice; and the Practice shall not, directly or indirectly hire, engage, contract, or enter into an arrangement with a third party where the Practice is the recipient of services that are similar to the Services.
7. Confidentiality and Proprietary Information.
8. HIPAA Obligations.
By agreeing to these Additional Terms, the Parties agree to the Business Associate Addendum attached hereto as Exhibit A, the terms of which are incorporated herein by reference as if recited herein. Practice shall obtain an authorization meeting the requirements of 45 C.F.R. § 164.508, as may be amended from time to time, and any applicable state laws to permit the disclosure of protected health information (as defined HIPAA) to SiteRx, SiteRx’s subsequent disclosure of such protected health information to Clinical Sites, and use of such protected health information by Clinical Sites for clinical trial eligibility and screening purposes.
9. Reporting.
Practice acknowledges that SiteRx has certain informational disclosure and reporting obligations under applicable federal and state laws, on behalf of itself or to third parties. Therefore, upon reasonable request by SiteRx, Practice agrees to promptly provide all information reasonably necessary for SiteRx to comply with such reporting obligations, and Practice represents and warrants that any such information shall be accurate and complete. Practice acknowledges that SiteRx will rely on information provided by Practice in meeting its reporting obligations and therefore, Practice agrees to indemnify SiteRx from any claims and expenses arising out of or related to any failure by Practice to comply with any of the foregoing provisions.
10. Setoff.
Notwithstanding anything to the contrary herein, in the event that it is discovered that the Practice Services rendered were non-compliant with applicable law, industry best practices, or the terms of this Agreement, SiteRx shall have the right to set off any payment, either in whole or in part, against any other payment it is otherwise required to make under this Agreement, without obligation or liability to Practice.
11. Insurance.
Practice shall maintain for such length of time as necessary to cover any and all claims arising out of or relating to the Services performed under this Agreement, professional liability insurance in the following minimum coverage amounts: $250,000 per occurrence and $750,000 in the aggregate covering each physician providing the Services. Upon SiteRx’s request, Practice shall furnish a copy of the certificate of insurance evidencing such coverage.
12. Audit Rights.
SiteRx on behalf of itself, and the Clinical Sites and Sponsors with which it contracts, shall have the right, during regular business hours and with reasonable notice, to perform monitoring and/or auditing activities on-site and/or off-site with respect to Practice’s performance hereunder, the proper use of the Platform and the quality of Practice Services, and/or to confirm the Practice is in compliance with this Agreement.
13. Warranties.
14. Indemnification.
15. DISCLAIMER; LIMITATION OF LIABILITY.
16. Miscellaneous.
This BUSINESS ASSOCIATE ADDENDUM (this “BAA”) is entered into as of the Effective Date by and between the Practice (for purposes of this BAA, the “Covered Entity”) and SiteRx (for purposes of this BAA, the “Business Associate”).
RECITALS
WHEREAS, the Business Associate performs healthcare operations services (for purposes of this BAA, the “Services”) on behalf of Covered Entity pursuant to the Agreement.
WHEREAS, the Agreement involves the Use and/or Disclosure of Protected Health Information (defined below); and
WHEREAS, the parties desire to enter into this BAA in order to comply with HIPAA.
NOW, THEREFORE, the parties do hereby agree as follows:
1. Definitions. Capitalized terms not otherwise defined in this BAA shall have the same meaning as those terms in the Agreement or in the Privacy Rule and the Security Rule (defined below).
2. Business Associate Obligations.
3. Covered Entity Obligations.
4. Term & Termination.
5. Required Disclosure. If Business Associate is confronted with legal action to disclose any PHI, Business Associate shall, to the extent permitted, promptly notify Covered Entity of such action. Thereafter, upon request by Covered Entity, Business Associate shall use reasonable efforts to assist Covered Entity in obtaining a protective order or other similar order and shall disclose only the minimum amount of PHI that is required to be disclosed in order to comply with the legal action, whether or not a protective order or other order has been obtained.
6. Compliance with Laws. Business Associate shall comply with all applicable federal, state and local laws, rules and regulations. To the extent that Covered Entity’s operations constitute a “Part 2 Program” as defined in the federal alcohol and drug rehabilitation regulations at 42 C.F.R. Part 2 (“Part 2”), and PHI provided to Business Associate contains “records” as defined in 42 C.F.R. § 2.11 (“Substance Use Disorder Records”), Business Associate acknowledges that, with respect to Substance Use Disorder Records and in receiving, storing, processing, or otherwise dealing with Substance Use Disorder Records, Business Associate is fully obligated and bound to comply with Part 2. Business Associate (i) shall use, disclose, and release Substance Use Disorder Records in accordance with Part 2, and (ii) if necessary, will resist in judicial proceedings any efforts to obtain access to Substance Use Disorder Records and patient identifying information related to substance use disorder diagnosis, treatment, or referral for treatment except as permitted by Part 2. With respect to the Part 2 Program, Business Associate also will be a qualified service organization as defined under Part 2.
7. Conflict. Except as specifically required to implement the purposes of this BAA, and except to the extent inconsistent with this BAA, all terms of the Agreement shall remain in full force and effect. In the event of a conflict between the terms of the Agreement and this BAA, this BAA shall control. This BAA supersedes any and all other agreements between the parties related to this subject matter.
8. No Third-Party Beneficiaries. Nothing express or implied in this BAA is intended to confer, nor shall anything herein confer, upon any person other than the Covered Entity, Business Associate and their respective successors or assigns, any rights, remedies, obligations or liabilities whatsoever.
9. Amendment. The parties shall amend this BAA from time to time by mutual written agreement in order to keep this BAA consistent with any changes made to the HIPAA laws or regulations in effect as of the Effective Date and with any new regulations promulgated under HIPAA. Covered Entity may terminate this BAA in whole or in part if the parties are unable to agree to such changes by the compliance date for such new or revised HIPAA laws or regulations.