ClinOne Terms of Service
Last Revised: 3/15/2023 12:00:00 AM

ClinOne, Inc. ("ClinOne", "we", "our", or "us") provides the web-based clinical trial enrollment, consent, data capture, compliance and engagement platform known as "ClinTrialConnect" (the "Platform") and we may provide software that may be downloaded to your smartphone or tablet to access services (each a " Mobile Applications "). The Platform, the Mobile Applications, and the services which ClinOne provides to you in connection with the Platform and Mobile Applications, are referred to as the "Services".

ClinOne provides the Services in connection with clinical studies (each a "Study"). You may be accessing the Services as an individual participant in the Study (a "Patient") or as a representative of a hospital, clinic, university, or other site conducting the Study (a "Site").

These Terms of Service (these "Terms") are a legal agreement between you and ClinOne governing your access to and use of the Services. If you are accessing the Services on behalf of a Site, then you represent and warrant that you have the right to bind the Site to these Terms, and all other references to the term "you" in these Terms shall be considered references to the Site. These Terms are separate and apart from any agreements between a Site, a Participant, and/or the party sponsoring the Study or their service providers (the "Sponsor"), including, without limitation, any Informed Consent (defined below) or applicable Clinical Trial Agreement.

BY REGISTERING FOR THE SITE OR SERVICE, OR BY OTHERWISE ACCESSING THE SITE OR USING ANY OF THE SERVICES YOU AGREE TO BE BOUND BY THESE TERMS. IF YOU DO NOT AGREE TO THESE TERMS YOU MAY NOT ACCESS OR USE THE SERVICES.

You represent and certify that you are of legal age to form a binding contract and are not a person barred from receiving services under the laws of the United States or other applicable jurisdictions. To register an Account with ClinOne, you must be 18 years or over. If you are between the age of 13 and 18, you will only use the Services under the supervision of a parent or legal guardian who agrees to be bound by these Terms. Any use or access to the Services by individuals under the age of 13 (or equivalent minimum age in the jurisdiction where you reside) is strictly prohibited and is a violation of these Terms.

1. SERVICES.
   1. Accounts and Registration. You may access and use certain features of the Services by creating a ClinOne User Account (your "Account"). You may log into your Account to use such Services using a unique username and password. You are responsible for safeguarding your password and you agree not to disclose your password to any third party. You are solely responsible for any activities or actions taken under your username, whether or not you have authorized such activities or actions. You agree that the information that you provide to ClinOne about yourself upon registration of your Account, and at all other times, (" User Data ") will be true, accurate, current and complete, and you further agree that you will maintain and promptly update the User Data to ensure that it remains true, accurate, current and complete. You may not impersonate any other person or use a username or password that you are not authorized to use. ClinOne reserves the right to require you to change your password for any reason at any time. If you become aware of any unauthorized use of your Account, you agree to notify ClinOne Support immediately at support@clinone.com. ClinOne is not liable for any loss or damage arising from your failure to comply with the above requirements.
   2. Platform License. Subject to these Terms, ClinOne grants you a personal, limited, revocable, non-exclusive, non-transferable, and non-sublicensable right to: (a) access and use the Services specifically made available to you as permitted by ClinOne in connection with an applicable Study (the "Permitted Purpose"), (b) download, install, and use the Mobile Application(s) made available by ClinOne for public use on your own handheld mobile device solely for the Permitted Purpose. This license is exclusive to you and you may not sublicense the use of the Services.
   3. Limitations. You expressly agree that you are solely responsible for any and all acts and omissions that occur through your use of the Platform, and you agree not to engage in any unacceptable uses of the Services, which include, without limitation, use of the Services to: (a) register an Account or otherwise access or use the Services if you have not acknowledged reading and agreed to abide by these Terms; (b) interfere, disrupt or attempt to gain unauthorized access to other accounts for the Services or any other computer network; (c) create user accounts by automated means or under fraudulent or false pretenses; (d) create or transmit unsolicited electronic communications such as spam to users or promote any products or services; (e) harass, threaten or intentionally embarrass or cause harm or distress to another person or group; (f) collect and publish any information about any of our users; (g) adapt, modify or reverse engineer any portion of the Services; (h) use any spider, robot, retrieval application, or any other device to retrieve any portion of the Services; (i) disseminate, store or transmit viruses, worms, Trojan horses or other malicious code or program; (j) encourage conduct that would constitute a criminal or civil offense; (k) violate any applicable federal, state, local or international law or regulation; (l) exploit any person, including but not limited to exploiting any child under 18 years of age; (m) invade the privacy of any person, including but not limited to submitting personally identifying or other private information about a person without their consent (or their parent’s consent in the case of a child under 13 years of age); (n) solicit personal information from a child under 18 years of age; (o) submit false or misleading information to ClinOne; (p) access the Services in order to build a similar or competitive service; or (q) engage in any other activity deemed by ClinOne to be in conflict with the spirit of these Terms. You agree that you (and not ClinOne) are responsible for ensuring that you comply with any applicable laws when you use the Services.
   4. Patient Informed Consent Agreement. If you are a Patient, you may be presented with an Informed Consent Agreement from Sponsor and/or a Site (each an " Informed Consent "). The Informed Consent is intended to describe the Study and what is involved in your participation in the Study. The Informed Consent should: (a) explain that the Study involves research and provide an explanation of the purpose of the research, (b) describe the expected length of time for participation in the Study, (c) describe all the procedures that will be completed during the Study, (d) describe any experimental procedures the will be completed during the Study, (e) describe any predictable risks of participation and any possible discomforts (e.g., injections, frequency of blood test etc.) that could occur as a result of the Study, (f) describe any possible benefits that may be expected from the Study, (g) provide information about any alternative procedures or treatment (if any) that might benefit you, (h) provide details about how information relating to your participation in the Study will be maintained, and (i) provide information about your right to refuse continued treatment or participation in the Study. Informed Consents may be updated from time to time throughout the course of a Study. When an Informed Consent is updated, you will be asked to review and consent to the updated Informed Consent. While ClinOne may review Informed Consent forms provided by Sponsors or Sites, ClinOne is not responsible for the contents of any Informed Consent or for a Sponsor’s or Site’s compliance with the Informed Consent. Whether or not you agree to an Informed Consent, or any updates thereto, is entirely your own decision.
   5. App Store Terms. You acknowledge and agree that the availability of a Mobile Application is dependent on the third party websites from which you download the mobile apps, e.g., the App Store from Apple or the Android app market from Google (each an " App Store "). You acknowledge that these Terms are between you and ClinOne, and not with an App Store. Each App Store may have its own terms and conditions to which you must agree before downloading Mobile Apps from it. You agree to comply with, and your license to use the Mobile Apps is conditioned upon your compliance with, such App Store terms and conditions. To the extent such other terms and conditions from such App Store are less restrictive than, or otherwise conflict with, the terms and conditions of these Terms, the more restrictive or conflicting terms and conditions in these Terms apply.
   6. Medical Emergencies; Participation Concerns. If you suffer a medical emergency in connection with your participation in a Study, please contact your local Emergency Services immediately and notify your clinical research Site. For any other questions or concerns relating to your participation in a Study, please contact your clinical research Site.
2. HEALTH INFORMATION; USER MATERIALS AND SUBMISSIONS.
   1. Copyright in Your User Materials. In connection with your access to, or use of, the Services, you may have the opportunity upload or provide certain information, data, text, video, messages, or other materials ("User Materials"). The term User Materials specifically excludes health and clinical study information made available by a Site or Sponsor pursuant to an Informed Consent ("Health Information"). ClinOne does not claim ownership rights in any such User Materials that you make available. By submitting your User Materials and accepting the consideration set forth in these Terms, you unconditionally grant to ClinOne a non-exclusive, perpetual, irrevocable, worldwide, fully-paid, transferable right and license, with the right to sublicense through multiple levels of sublicensees, under all of your intellectual property rights in the User Materials, to (a) reproduce, create derivative works of, distribute, publicly perform, publicly display, digitally transmit, and otherwise use the User Materials in any medium or format, whether now known or hereafter discovered and (b) exercise any and all other present or future rights in the User Materials.
   2. Distribution of User Materials. You agree that you will not contribute any User Materials that: (a) is defamatory, abusive, harassing, threatening, or an invasion of a right of privacy of another person; (b) is illegal or encourages or advocates illegal activity or the discussion of illegal activities with the intent to commit them, including a submission that is, or represents an attempt to engage in, child pornography, stalking, sexual assault, fraud, trafficking in obscene or stolen material, drug dealing and/or drug abuse, harassment, theft, or conspiracy to commit any criminal activity; (c) infringes or violates any right of a third party including any copyright, patent, trademark, trade secret or other proprietary or contractual rights, right of privacy (specifically, you must not distribute another person’s personal information of any kind without their express permission) or publicity, or any confidentiality obligation; or (d) contains a virus or other harmful component, or otherwise tampers with, impairs or damages the Services or any connected network, or otherwise interferes with any other person or entity’s use or enjoyment of the Services.
   3. Review of Health Information and User Materials. While ClinOne does not and cannot review all third party material uploaded in connection with the Services, and is not responsible for its content, ClinOne reserves the right to remove, delete, move, or edit User Materials that it, in its sole discretion, deems abusive, defamatory, obscene, in violation of the law, including but not limited to copyright or trademark law, or otherwise unacceptable. ClinOne will not be liable for any Health Information or User Materials submitted by you or any other party.
3. THIRD PARTY SOFTWARE AND LINKING.
   1. Open Source Software. Certain items of software included with the Services may be subject to "open source" or "free software" licenses (" Open Source Software "). Nothing in these Terms limits your rights under, or grants you rights that supersede, the terms and conditions of any applicable end user license for the Open Source Software. If required by any license for particular Open Source Software, ClinOne makes such Open Source Software, and any ClinOne’ modifications to that Open Source Software, available by written request to ClinOne at the email or mailing address included in these Terms.
   2. Third Party Services. The Services may reference, contain links to, or integrate with, other websites or services provided by third parties (" Third Party Services "). Such Third Party Services are not under our control. ClinOne provides these links only as a convenience and does not review, approve, monitor, endorse, warrant, or make any representations with respect to such Third Party Services. Your use of these Third Party Services is at your own risk.
4. SUSPENSION AND TERMINATION. ClinOne reserves the right to suspend or terminate your Account and your access to and use of the Services, at any time, without notice. ClinOne reserves the right at any time and from time to time to modify or discontinue, temporarily or permanently, the Services (or any part thereof) with or without notice. You agree that ClinOne shall not be liable to you or to any third party for any modification, suspension or discontinuance of the Services. Termination or suspension of your Account and/or access to or use of the Services does not terminate or suspend your participation in a Study, whether as a Site or a Patient. If you are a Patient, you must contact the Site directly to terminate or suspend your participation in the Study. If you are a Site, your ability to terminate or suspend participation in a Study is governed by your separate agreement with Sponsor.
5. OWNERSHIP AND INTELLECTUAL PROPERTY. You acknowledge that all intellectual property rights, including without limitation copyrights, patents, trademarks, and trade secrets, in the Services (i.e., the Platform and Mobile Applications) are owned by ClinOne its licensors. Your access to or use of the Services does not transfer to you or any third party any rights, title, or interest in or to such intellectual property rights. ClinOne and its affiliates and licensors and suppliers reserve all rights not granted in these Terms. You may not copy or incorporate any of the content of the Services into any work, including your own website without the written consent of ClinOne. You must have a license from us before you can post or redistribute any portion of the Services. Other than with respect to your Health Information or User Materials, ClinOne retains full and complete title to all content on the Services, including any downloadable software and all data that accompanies it. You may not modify the Services, create derivative works of the Services, or reverse engineer, reverse compile, reverse assemble or do any other operation with the Services that would reveal any source code, trade secrets, know-how or other proprietary information. Nothing in these Terms shall be construed or interpreted as granting or providing rights to you to use, reproduce, modify, distribute, perform, display, possess or control the source code or any other aspect of the Services. You may not remove or modify any notice of confidentiality, trade secret, trademark or copyright encoded, embodied, or displayed in connection the Services. You may use the Services only while these Terms remain in effect. Under no circumstances shall you have any rights of any kind in or to the Services after any termination or expiration of your agreement to these Terms for any reason.
6. DISCLAIMERS OF WARRANTY.
   1. THE SERVICES ARE PROVIDED ON AN "AS IS" AND "AS AVAILABLE" BASIS AND WITHOUT WARRANTIES OF ANY KIND. CLINONE EXPRESSLY DISCLAIMS ALL WARRANTIES, WHETHER EXPRESS OR IMPLIED, WITH RESPECT TO THE SERVICES, INCLUDING, BUT NOT LIMITED TO, IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NON-INFRINGEMENT. NO ADVICE OR INFORMATION GIVEN BY CLINONE, ITS EMPLOYEES OR AFFILIATES SHALL CREATE A WARRANTY.
   2. CLINONE MAKES NO WARRANTY THAT THE SERVICES WILL BE UNINTERRUPTED, TIMELY, SECURE OR ERROR FREE, THAT THE SERVERS ARE FREE OF VIRUSES OR OTHER HARMFUL COMPONENTS, THAT THE SERVICES WILL BE AVAILABLE, OR THAT DATA WILL BE SECURE FROM UNAUTHORIZED ACCESS.
   3. CLINONE DOES NOT WARRANT, ENDORSE, GUARANTEE, OR ASSUME RESPONSIBILITY FOR ANY ASPECT OF THE STUDY, THE ACCURACY OF ANY INFORMED CONSENT, OR THE CONDUCT OF SPONSOR, ANY SITE, OR ANY PATIENT. CLINONE MAKES NO REPRESENTATIONS OR WARRANTIES REGARDING ANY THIRD PARTY SERVICES.
   4. CLINONE MAKES NO REPRESENTATIONS CONCERNING ANY USER MATERIALS CONTAINED IN OR ACCESSED THROUGH THE SERVICES, AND CLINONE WILL NOT BE RESPONSIBLE OR LIABLE FOR THE ACCURACY, COPYRIGHT COMPLIANCE, LEGALITY OR DECENCY OF MATERIAL CONTAINED IN OR ACCESSED THROUGH THE SERVICES.
7. PROPRIETARY AND PRIVACY PROTECTION FOR OTHER USERS ON THE PLATFORM. ClinOne hereby notifies you that all the information, content, image files, software and materials on the Platform may be protected by U.S. and international copyright and other intellectual property laws and by other applicable laws, including privacy laws. ClinOne is unable to provide you with permission to copy display or distribute material for which you do not own the copyright or other intellectual property rights. You may not copy or distribute such material without the written consent of the owner, and you are solely responsible for any copyright or other intellectual property law violations that you may incur as a result of your activities on the Platform. ClinOne has the absolute right to terminate your Account or exclude you from the Services if you violate the intellectual property rights or other rights of third parties. Unless prohibited by state or federal laws to which you are subject, you agree to indemnify and hold ClinOne harmless for any violation of this provision.
8. INDEMNITY; LIMITATION OF LIABILITY.
   1. Unless prohibited by state or federal laws to which you are subject, you agree to indemnify, and hold ClinOne, its officers, directors, employees and agents, harmless from and against any claims, liabilities, damages, losses, and expenses, including without limitation reasonable attorney’s fees and costs, arising out of or in any way connected with (a) your access to or use of the Services; (b) your access to or use of any Third Party Service; (c) your violation of these Terms; (d) your violation of any third party right, including without limitation any intellectual property right or any publicity, confidentiality, property or privacy right (e) your negligent or willful acts or omissions, (f) an allegation that you failed to comply with any applicable laws, rules, or regulations, and/or (g) if you are a Site, your conduct of the Study or compliance with an Informed Consent form, (including any Informed Consent form). ClinOne reserves the right, at your expense, to assume the exclusive defense and control of any matter for which you are required to indemnify ClinOne and you agree to cooperate with our defense of such claims. You agree not to settle any such claim without ClinOne’ prior written consent. ClinOne will use reasonable efforts to notify you of any such claim, action or proceeding upon becoming aware of it.
   2. YOU AGREE THAT, TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, UNDER NO CIRCUMSTANCES SHALL CLINONE BE LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL OR CONSEQUENTIAL DAMAGES, INCLUDING, BUT NOT LIMITED TO, DAMAGES FOR LOSS OF PROFITS, USE, IMAGES, DATA OR OTHER INTANGIBLES, EVEN IF CLINONE HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, THAT RESULT FROM THE USE OR THE INABILITY TO USE THE SERVICES, FROM ANY CHANGES TO THE SERVICES OR FROM UNAUTHORIZED ACCESS TO OR ALTERATION OF YOUR TRANSMISSIONS OR USER MATERIALS. YOU SPECIFICALLY ACKNOWLEDGE THAT DOWN-TIME AND COMPUTER VIRUSES ARE RISKS INHERENT IN THE USE OF THE INTERNET AND SOFTWARE PRODUCTS, AND YOU AGREE TO ASSUME RESPONSIBILITY FOR ANY HARM OR DAMAGES OF ANY KIND OR CHARACTER WHATSOEVER RESULTING FROM THESE POSSIBLE HARMS. YOU ALSO SPECIFICALLY ACKNOWLEDGE THAT YOU MAY BE DISCLOSING SENSITIVE, PRIVATE AND CONFIDENTIAL INFORMATION ABOUT YOURSELF IN CONNECTION WITH THE STUDY AND YOUR USE OF THE SERVICES AND YOU AGREE TO RELEASE CLINONE FROM RESPONSIBILITY FOR ANY HARM OR DAMAGES OF ANY KIND OR CHARACTER WHATSOEVER RESULTING FROM YOUR RELEASE OF SUCH USER MATERIALS.
   3. IF YOU ARE DISSATISFIED WITH THE SERVICES OR WITH ANY OF THESE TERMS, OR FEEL CLINONE HAS BREACHED THESE TERMS, YOUR SOLE AND EXCLUSIVE REMEDY IS TO DISCONTINUE USING THE SERVICES. THE TOTAL LIABILITY OF CLINONE TO YOU FOR ANY CLAIM ARISING FROM OR RELATING TO THESE TERMS OR USE OF SERVICES SHALL NOT EXCEED THE AMOUNT PAID BY YOU FOR THE SERVICES DURING THE TWELVE MONTHS PRECEDING THE EVENT GIVING RISE TO THE LIABILITY, IF ANY. IT IS THE INTENTION OF YOU AND CLINONE THAT THIS PROVISION BE CONSTRUED BY A COURT AS BEING THE BROADEST LIMITATION OF LIABILITY CONSISTENT WITH APPLICABLE LAW.
   4. SOME JURISDICTIONS DO NOT ALLOW THE LIMITATION OR EXCLUSION OF INCIDENTAL, CONSEQUENTIAL OR OTHER TYPES OF DAMAGES, SO SOME OF THE ABOVE LIMITATIONS MAY NOT APPLY TO YOU. NOTHING IN THESE TERMS AND IN PARTICULAR WITHIN THIS "INDEMNITY; LIMITATION OF LIABILITY" CLAUSE SHALL ATTEMPT TO EXCLUDE LIABILITY THAT CANNOT BE EXCLUDED UNDER APPLICABLE LAW.
9. RELEASE. You hereby release and forever discharge us (and our officers, employees, agents, successors, and assigns) from, and hereby waive and relinquish, each and every past, present, and future dispute, claim, controversy, demand, right, obligation, liability, action, and cause of action of every kind and nature (including personal injuries, death, and property damage), that has arisen or arises directly or indirectly out of, or relates directly or indirectly to: (a) Sponsor, (b) the Study, (c) any Informed Consent or the breach thereof by any person, (d) any interactions with, or act or omission of, Sponsor or other users of the Service, (e) any Third Party Service, and/or, (f) if you are a Patient, any interactions with, or act or omission of, the Site. IF YOU ARE A CALIFORNIA RESIDENT, YOU HEREBY WAIVE CALIFORNIA CIVIL CODE SECTION 1542 IN CONNECTION WITH THE FOREGOING, WHICH STATES: "A GENERAL RELEASE DOES NOT EXTEND TO CLAIMS WHICH THE CREDITOR DOES NOT KNOW OR SUSPECT TO EXIST IN HIS OR HER FAVOR AT THE TIME OF EXECUTING THE RELEASE, WHICH IF KNOWN BY HIM OR HER MUST HAVE MATERIALLY AFFECTED HIS OR HER SETTLEMENT WITH THE DEBTOR."
10. GENERAL.
    1. Modification. ClinOne may modify these Terms at any time. Modifications become effective immediately upon your first access to or use of the Platform or Services after the "Last Revised" date at the top of these Terms. Your continued access to or use of the Platform or Services after the modifications have become effective will be deemed your conclusive acceptance of the modified Terms. If you do not agree with the modifications, do not access or use the Platform or Services.
    2. Applicable Law and Dispute Resolution. These Terms shall be governed by the laws of the State of Colorado without giving effect to any conflict of laws principles that may require the application of the law of another jurisdiction. If you believe that ClinOne has not adhered to these Terms, please contact us by e-mail at compliance@clinone.com. We will do our best to address your concerns. If you feel that your complaint has been addressed incompletely, we invite you to let us know for further investigation. If you and ClinOne are unable to reach a resolution to the dispute, you and ClinOne will settle the dispute exclusively under the rules of the American Arbitration Association (www.adr.org) at its Denver, Colorado office. Any election to arbitrate by one party will be final and binding on the other. YOU UNDERSTAND THAT IF EITHER PARTY ELECTS TO ARBITRATE, NEITHER PARTY WILL HAVE THE RIGHT TO SUE IN COURT OR HAVE A JURY TRIAL. YOU AND CLINONE AGREE THAT ANY ARBITRATION WILL BE LIMITED TO THE DISPUTE BETWEEN CLINONE AND YOU INDIVIDUALLY. YOU ACKNOWLEDGE AND AGREE THAT YOU AND CLINONE ARE EACH WAIVING THE RIGHT TO PARTICIPATE AS A PLAINTIFF OR CLASS MEMBER IN ANY PURPORTED CLASS ACTION OR REPRESENTATIVE PROCEEDING. Further, unless both you and ClinOne otherwise agree in writing, an arbitrator may not consolidate more than one person’s claims, and may not otherwise preside over any form of any class or representative proceeding. Regardless of any statute or law to the contrary, any claim or cause of action arising out of or related to the use of the Services or these Terms must be brought, if at all, within one year from the accrual of the claim or cause of action or be forever barred. Notwithstanding the foregoing, ClinOne may seek injunctive or other equitable relief to protect its confidential information and intellectual property rights or to prevent loss of data or damage to its servers in any court of competent jurisdiction. If you are subject to any state or federal law requiring that the laws of a different jurisdiction apply or that prohibit dispute resolution in the manner required in this Section, then this Section shall be deemed revised to conform with such laws.
    3. Independent Contractors. No joint venture, partnership, employment, or agency relationship exists between you and ClinOne as a result of these Terms or use of the Services.
    4. Waiver. The failure of ClinOne to enforce any right or provision in these Terms will not constitute a waiver of such right or provision unless acknowledged and agreed to by ClinOne in writing.
    5. Construction. The headings of Sections of these Terms are for convenience and are not to be used in interpretation.
    6. Contact. ClinOne is located in Denver, Colorado. Any questions, comments or suggestions, including any report of violation of these Terms should be provided ClinOne as follows:

                By E-mail:                  compliance@clinone.com

                By Postal Mail:          5600 S Quebec Street, Suite B310, Greenwood Village, CO 80111

    7. Entire Agreement. These Terms constitute the entire agreement between you and ClinOne with respect to the Services, superseding any prior agreements between you and ClinOne. The failure of ClinOne to exercise or enforce any right or provision of these Terms shall not constitute a waiver of such right or provision. If any provision of these Terms is found by a court of competent jurisdiction to be invalid, you and ClinOne nevertheless agree that the court should endeavor to give effect to the parties’ intentions as reflected in the provision, and the other provisions of these Terms shall remain in full force and effect.