Terms of Service

The purpose of this Terms of Service (“Agreement”) is to establish the legally binding terms and conditions under which Topography will provide Services as described in a Research Site Order Form upon execution of such Research Site Order Form. In the event of any inconsistency or conflict between the terms of this Agreement and the Research Site Order Form, the Research Site Order Form will control.

  1. Definitions.The following terms have the following meanings:

    “Business Associate”shall have the meaning set forth in HIPAA at 42 C.F.R. § 160.103.

    “Confidential Information” means all information disclosed by a party (“Disclosing Party”) to the other party (“Receiving Party”), whether orally or in writing, that is designated confidential or that reasonably should be understood to be confidential given the nature of the information and the circumstances of disclosure, including, without limitation, the terms and conditions of this Agreement, business and marketing plans, technology and technical information, scientific information, product plans and designs, and business processes disclosed by such Party. Confidential Information does not include any information that (i) is or becomes generally known to the public without breach of any obligation owed to the Disclosing Party, (ii) was known to the Receiving Party prior to its disclosure by the Disclosing Party without breach of any obligation owed to the Disclosing Party, (iii) is received from a third party without knowledge of any breach of any obligation owed to the Disclosing Party, (iv) was independently developed by the Receiving Party, or (v) constitutes “Protected Health Information.”

    “Effective Date” means the Effective Date in the Research Site Order Form.

    “EMR” means the Research Site’s electronic medical record.

    “HIPAA” means the Health Insurance Portability and Accountability Act of 1996, the Health Information Technology for Economic and Clinical Health Act, and their implementing regulations as amended from time to time.

    “Intellectual Property Rights”means any registered and unregistered intellectual property rights, including but not limited to patents, industrial designs, trademarks, copyrights, know-how, and trade secrets, and any corresponding applications and registrations.

    “Protected Health Information” shall have the meaning set forth in HIPAA at 45 CFR § 160.103.

    “Non-Topography Technology” means software or applications that interoperate with a Service that is provided by the Research Site or a third party (such as a Research Site’s electronic medical record provider).

    “Research Site Data” means data (including Protected Health Information) submitted to Topography in connection with the Services or directly extracted from the Research Site’s EMR in connection with the Services.

    “Research Site Order Form” means an ordering document specifying the Services to be provided to Research Site that is entered into between Topography and Research Site, including any addenda thereto.

    “Services” means the services that are ordered by Research Site pursuant to a Research Site Order Form.

    “Sponsor” means an entity that has elected to serve as a sponsor of the Study.

    “Study” means a clinical trial being conducted at a Research Site.

  2. Services.Subject to the terms of this Agreement, Topography will provide the Services to Research Site upon execution of the Research Site Order Form. Research Site agrees and acknowledges that the Services provided by Topography under this Agreement, while at the request of and paid for by the Sponsor, are for the benefit of the Research Site, which is sufficient consideration to form this Agreement.

  3. Cooperation and EMR Access.Research Site acknowledges that the Services require that Topography have front-end and back-end access to Research Site’s EMR and that Topography must be able to export patient records in furtherance of the Services. Research Site represents and warrants that it has all rights, authorizations, consents, and other permissions necessary to perform its obligations under this Agreement and to grant any third party license necessary for Topography to exercise its rights under this Agreement. Research Site will provide Topography access to systems and applications as required for Topography to perform the Services and cooperate in good faith to facilitate Topography’s access to Research Site’s EMR in a timely manner. Research Site shall make available appropriate personnel, including investigators and technology professionals, to support the provision of the Services on an as needed basis.

  4. Topography Personnel.Topography shall be solely responsible for all fees, expenses, taxes, workers compensation, or other payments relating to Topography personnel.

  5. Confidential Information.

    5.1. As between the Parties, each Party retains all ownership rights in and to its Confidential Information.

    5.2. The Receiving Party shall use the Disclosing Party’s Confidential Information only in connection with performing its obligations hereunder or as contemplated by this Agreement, or for such other purpose as may be agreed upon in writing by the Parties. The Receiving Party shall safeguard the Disclosing Party’s Confidential Information with the same degree of care that the Receiving Party uses to protect its own proprietary or confidential information of a similar nature, but no less than a reasonable degree of care.

    5.3. The Receiving Party shall not publish, disseminate, or otherwise disclose any Confidential Information of the Disclosing Party except in accordance with this Agreement. The Receiving Party may disclose Confidential Information to persons within its organization that have a need to receive such Confidential Information to further the purposes of this Agreement and that are bound to protect the confidentiality of such Confidential Information. Notwithstanding the foregoing, each Party may confirm the existence of this Agreement to the Sponsor. If required, the Receiving Party may disclose Confidential Information to a governmental authority or by order of a court of competent jurisdiction, provided that the Receiving Party (i) provides prompt written notice to the Disclosing Party of the existence, terms, and circumstances surrounding such request, unless prohibited by applicable law, (ii) reasonably cooperates with the Disclosing Party on any steps the Disclosing Party takes to attempt to prevent, limit, or protect the disclosure, and (iii) uses reasonable efforts to limit the disclosure to only that information it is required to disclose in connection with the request.

    5.4. Upon expiration or termination of this Agreement, and upon written request by the Disclosing Party, the Receiving Party shall return all Disclosing Party’s Confidential Information to Disclosing Party; provided, however, that the Receiving Party may retain one copy of Confidential Information for archival, regulatory, or legal purposes.

    5.5. The obligations of confidentiality and non-disclosure under this Agreement continue during the term of the Agreement and will survive for a period of seven (7) years following the expiration or termination of this Agreement.

    5.6. Given the unique nature of Confidential Information, the Parties agree that any violation or threatened violation by a Party with respect to Confidential Information may cause irreparable injury to the other Party. Therefore, the Parties agree such violation or threatened violation shall entitle the other Party to seek injunctive or other equitable relief in addition to all legal remedies.

  6. HIPAA.

    6.1.Business Associate Agreement. To the extent that Research Site is a “Covered Entity” or “Business Associate” and Topography is a “Business Associate” or “Subcontractor” of Research Site, the relevant “Business Associate” services will be governed by the Business Associate Agreement between the Parties, which is hereby incorporated herein by reference. In the event of a conflict between the terms of this Agreement and the terms of the Business Associate Agreement, the terms of the Business Associate Agreement shall apply with respect to permitted uses and disclosures of Protected Health Information. In all other respects, the terms of this Agreement shall control unless expressly indicated otherwise.

    6.2.Reviews Preparatory to Research. To the extent that Topography provides Services that do not constitute Business Associate functions, but are activities consistent with “reviews preparatory to research” (as defined in HIPAA), the Parties agree that Topography may use and disclose Protected Health Information for such reviews preparatory to research in accordance with the representations set forth in 45 C.F.R. § 164.512(i)(1)(ii) and any HHS guidance regarding the same, including, but not limited to, guidance on remote access to Protected Health Information for purposes of reviews preparatory to research. Research Site hereby makes all of the representations set forth in 45 C.F.R. § 164.512(i)(1)(ii). In addition, (i) Research Site represents that it has conducted a risk analysis and implemented appropriate safeguards sufficient to permit Topography to temporarily download the minimum necessary amount of Protected Health Information necessary for purposes of the preparatory to research activities, and (ii) Research Site represents that it will use secure methods for accessing, receiving, and downloading the Protected Health Information and will securely purge any temporary Protected Health Information that is no longer needed for the preparatory to research activities.

  7. Compliance.

    7.1. In performing their respective obligations under this Agreement, each Party shall comply with applicable law.

    7.2. The Parties agree that nothing contained in the Agreement or any Research Site Order Form is intended to require the Research Site (or any physician that is employed or contracted by the Research Site) to use, order, purchase, or recommend any of Sponsor’s products or services. Notwithstanding any unanticipated effect of any provision of this Agreement, no Party will knowingly or intentionally conduct its behavior in such a manner as to violate 42 U.S.C. § 1320a-7b(b) (commonly known as the Anti-Kickback Statute), 42 U.S.C. § 1395nn (commonly known as the Stark law), and any other federal or state law provision governing fraud and abuse or self-referrals under the Medicare or Medicaid programs, as such provisions may be amended from time to time.

  8. Fees and Payment.The Research Site Order Form shall govern the fees and payment schedule relating to the Services.

  9. Mutual Representations.Each Party represents and warrants that it (i) has validly entered into this Agreement and has the legal power to do so, (ii) is under no contractual or other obligation or restriction which is inconsistent with such Party’s execution of this Agreement or the performance of their respective obligations hereunder, and (iii) has not received or been offered any illegal or improper bribe, kickback, payment, gift, or thing of value from an employee or agent of the other Party in connection with this Agreement (reasonable gifts and entertainment provided in the ordinary course of business do not violate the above restriction).

  10. Integration with Non-Topography Technology.The Services may contain services or features designed to interoperate with Non-Topography Technology. Topography does not warrant or support Non-Topography Topography and cannot guarantee the security, functionality, or availability of such Non-Topography Technology.

  11. Intellectual Property and Data.Between Topography and Research Site, Research Site owns Research Site Data. Topography is the sole and exclusive owner of all right, title, and interest in and to any data, technology, software, formulas, techniques, or know-how and other tangible and intangible items that are owned or created by Topography, including all Intellectual Property Rights therein. The Parties agree that, unless otherwise expressly stated herein, neither Party transfers by operation of this Agreement to any other party any Intellectual Property Rights. Topography reserves all of its right, title, and interest in and to the Services, including all of their related Intellectual Property Rights. Research Site hereby grants Topography a limited, non-exclusive, transferable, sublicensable, royalty-free license during the term of this Agreement to copy, aggregate, compile, modify, distribute (directly or indirectly), publish, transmit, and create derivative works from Research Site Data as necessary for Topography to provide the Services and perform its obligations and exercise its rights under this Agreement. Topography may de-identify any data that it receives under this Agreement and use such de-identified data to perform the Services and for any purpose permitted by applicable law. The Parties agree that Topography is the exclusive owner of Research Site Data that has been de-identified by Topography. Any feedback or suggestions in respect to the Services are shared on a non-confidential, non-proprietary basis and Research Site hereby grants to Topography a perpetual, irrevocable right to use and fully exploit all such feedback or suggestions for any lawful purposes without any further obligation to Research Site.

  12. Term; Termination; Suspension.This Agreement commences on the Effective Date and continues for a period of three (3) years from the Effective Date. Thereafter, this Agreement will automatically renew for successive one-year periods unless either Party provides written notice of cancellation no less than 60-days prior to the end of the then-current term. A Party may terminate this Agreement for cause (i) upon 30 days written notice to the other Party of a material breach if such breach remains uncured at the expiration of such period, or (ii) if the other Party becomes the subject of a petition in bankruptcy or any other proceeding relating to insolvency, receivership, liquidation, or assignment for the benefit of creditors. In the event of any termination of this Agreement, Topography shall deliver any Services through the date of termination. Without limiting any other rights or remedies, Topography reserves the right to suspend the Services for non-payment, system maintenance, or Research Site’s failure to comply with the terms of this Agreement.

  13. Informational Purposes Only.ALL SERVICES ARE PROVIDED TO RESEARCH SITE FOR INFORMATIONAL PURPOSES ONLY AND DO NOT CONSTITUTE RECOMMENDATIONS OR ADVICE. TOPOGRAPHY PROVIDES ALL SERVICES ON AN “AS IS” BASIS WITHOUT ANY WARRANTY OF ANY KIND AND MAKES NO REPRESENTATIONS OR WARRANTIES ABOUT THE SUITABILITY, RELIABILITY, TIMELINESS, OR ACCURACY OF THE SERVICES. THE SERVICES ARE PROVIDED WITHOUT ANY GUARANTEE OF CONTINUOUS OR UNINTERRUPTED AVAILABILITY. TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, TOPOGRAPHY DISCLAIMS ALL WARRANTIES, EITHER EXPRESS OR IMPLIED, STATUTORY OR OTHERWISE, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE AND IMPLIED WARRANTIES ARISING FROM COURSE OF DEALING, COURSE OF PERFORMANCE, USAGE OF TRADE, OR OTHERWISE. WITHOUT LIMITING THE FOREGOING, TOPOGRAPHY MAKES NO GUARANTEES WITH RESPECT TO THE PERFORMANCE OR COMPATIBILITY OF ANY PRODUCT OR SERVICE.

  14. Mutual Indemnification.Each Party agrees to indemnify, defend, and hold harmless the other Party and its officers, directors, employees, successors, and assigns from and against any claim, liability, loss, damage, cost, or expense (including reasonable attorneys’ fees) arising out of, resulting from, or relating to any third-party claim relating to the indemnifying Party’s (i) willful, wrongful, or negligent act or omission or (ii) breach of Section 5 (Confidential Information) or Section 9 (Mutual Representations) of this Agreement. Each Party shall notify the other immediately in writing of any claim related to activities performed pursuant to the Agreement, whether the claim is verbal or written, or whether informal or by summons and complaint; provided, however, that failure to provide such notification renders the indemnification obligations hereunder null and void. The Parties shall cooperate with each other in the investigation and disposition of any claim arising out of the activities of the Agreement; provided, however, that nothing herein shall require either Party to disclose any documents, records, or communications that are protected under the attorney-client privilege or the attorney work-product privilege. This “Mutual Indemnification” section states the indemnifying party’s sole liability to, and the indemnified party’s exclusive remedy against, the other party for any third-party claim described in this section.

  15. Limitation of Liability.IN NO EVENT WILL EITHER PARTY HAVE ANY LIABILITY ARISING OUT OF OR RELATED TO THIS AGREEMENT FOR ANY LOST PROFITS, REVENUES, GOODWILL, OR INDIRECT, SPECIAL, INCIDENTAL, CONSEQUENTIAL, COVER, BUSINESS INTERRUPTION, OR PUNITIVE DAMAGES, WHETHER AN ACTION IS IN CONTRACT OR TORT AND REGARDLESS OF THE THEORY OF LIABILITY, EVEN IF A PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES OR IF A PARTY’S REMEDY OTHERWISE FAILS OF ITS ESSENTIAL PURPOSE. THE FOREGOING DISCLAIMER WILL NOT APPLY TO THE EXTENT PROHIBITED BY LAW. IN NO EVENT SHALL THE AGGREGATE LIABILITY OF EACH PARTY ARISING OUT OF OR RELATED TO THIS AGREEMENT OR THE SERVICES EXCEED THE AMOUNT ACTUALLY PAID TO TOPOGRAPHY FOR THE SERVICES DURING THE ONE-YEAR PERIOD IMMEDIATELY PRECEDING THE DATE THAT THE CAUSE OF ACTION AROSE.

  16. Insurance.Each Party shall carry, with financially sound and reputable insurers, insurance coverage with respect to the conduct of its business against loss from such risks and in such amounts as is reasonable to meet the insurable obligations of indemnification contained in this Agreement.

  17. Miscellaneous.

    17.1.Use of Name.Neither Party shall use the other Party’s name in any form of advertising, promotion, or publicity without the prior written consent of the other Party. Notwithstanding the foregoing, Topography may utilize Research Site’s name and/or logo on Topography’s website and in marketing materials solely to identify Research Site as a customer of Topography. 17.2.Independent Contractor.Topography and Research Site are independent contractors and this Agreement will not establish any relationship of partnership, joint venture, employment, franchise, or agency between Topography and Research Site.

    17.3.Notices.All notices required by this Agreement shall be deemed given when in writing and delivered to the other Party at the address set forth above or at such other address as the Party may designate in writing. For all legal notices to Topography, Research Site will send a simultaneous copy via email to legal@jointopo.com

    17.4.Assignment.Except as provided herein, neither Party may assign the rights and obligations under this Agreement without the specific written consent of the other Party, which shall not be unreasonably withheld. Notwithstanding the foregoing, Topography may assign this Agreement to an affiliate or in connection with any merger or change of control of Topography, or the sale of all or substantially all of Topography’s assets.

    17.5.Cooperation.Research Site agrees to execute further documents and to take further actions as may be reasonably necessary to carry out the purposes and intent of this Agreement.

    17.6.Entire Agreement; Amendment.The Agreement, together with the Research Site Order Form and the Business Associate Agreement, constitutes the entire agreement between the Parties and supersedes and replaces any and all prior or contemporaneous understandings, proposals, representations, marketing materials, statements, or agreements, whether oral, written, or otherwise, regarding such subject. Topography may amend this Agreement from time to time, in which case the new agreement will supersede prior versions. Topography will notify Research Site not less than thirty (30) days prior to the effective date of any such amendment and Research Site’s continued use of the Services following the effective date of any such amendment may be relied upon by Topography as Research Site’s consent to any such amendment.

    17.7.Non-Exclusive Services.The Parties acknowledge that the Services are not provided on an exclusive basis and that nothing in this Agreement will prohibit Topography from providing Services to any other third party.

    17.8.Severability.If any provision of this Agreement is held by a court of competent jurisdiction to be contrary to law, the provision will be deemed null and void, and the remaining provisions of this Agreement will remain in effect.

    17.9.Governing Law. The Agreement has been executed and delivered in, and shall be construed and enforced in accordance with, the laws of the State of Delaware.

    17.10.Waiver.No failure or delay by either Party in exercising any right under this Agreement will constitute a waiver of that right.

    17.11.Force Majeure. Neither party shall be liable or be deemed in breach of this Agreement for any failure or delay of performance which results, directly or indirectly, from acts of God, military authority, public disturbance, fires, or any other similar cause beyond the reasonable control of either party.

    17.12.No Third Party Beneficiary.There are no third-party beneficiaries under this Agreement.

    17.13.Survival.The rights and obligations of either Party that by their nature would continue beyond the expiration or termination of this Agreement will survive expiration or termination of this Agreement, including without limitation payment obligations, confidentiality obligations, warranty disclaimers, indemnities, limitations of liability, definitions, and miscellaneous provisions.

    17.14.Independent Legal and Professional Advice. Each Party hereby acknowledges that it has obtained, or has had an opportunity to obtain, independent legal and professional advice in connection with this Agreement.

    17.15.Counterparts.This Agreement may be executed in one or more counterparts, each of which shall be deemed to be an original, but all of which together shall constitute one and the same instrument.

Last Updated: September 6, 2024