THREAD Study Application End User License Agreement
This End User License Agreement (“Agreement”) sets forth the terms and conditions upon which you may download and use the THREAD mobile application, related services, and all updates provided to you (collectively, “Study App”) by Definitive Media Corp. dba “THREAD” (“THREAD”) and/or its authorized distributors. “You”, “your”, “yourself” means you, as an individual.
The terms of this Agreement will govern the Study App and any software updates that change the original Study App. You agree to all terms, conditions, and restrictions in this Agreement. You agree that any use of the Study App that violates this Agreement invalidates this license. By downloading and using this Study App, you represent and warrant that you are at least 18 years old. If you are under 18 years of age, you represent and warrant that you have obtained your parent or legal guardian’s permission to use this Study App. You must not use the Study App if you are not allowed to do so under the laws of the country in which you are resident or from which you access or use the Study App.
- Permitted Use and Restrictions
- Grant of License and Reservations. Subject to the terms of this Agreement, THREAD grants you a limited, non-exclusive, revocable, non-transferable license to install and use the Study App and any future updates provided to you solely for use in connection with your participation in a remote patient study. This Study App is licensed, not sold, to you by THREAD for use only under the terms of this Agreement. THREAD reserves all rights not expressly granted to you. You may own the phone or other device on which the Study App is stored, but THREAD owns the Study App itself.
Reverse Engineering. Unless we allow you to do so in another part of this Agreement, you agree not to do the following activities related to the Study App:
- reverse engineer, de-compile, disassemble, alter, duplicate, modify, rent, lease, loan, sublicense, make copies, create derivative works from, distribute or provide others with the Study App, in whole or part, or transmit or communicate the Study App over a network or to any third party;
- lease, loan, sublicense, distribute, or otherwise provide others access to or with any aspect of the Study App; and
- develop, sell, or distribute applications that are capable of launching, being launched from, or are otherwise integrated with, the Study App or content accessed through the Study App unless we give you written permission.
Further Restrictions. You further agree to not use the Study App to do the following:
- Transmit, access, or communicate any data that you do not have the right to transmit, access, or communicate under applicable laws;
- transmit or communicate any data that contains software viruses or any other computer code, files, or programs designed, intended, or likely to interrupt, destroy or limit the functionality of any computer software or hardware;
- interfere with or disrupt or circumvent the Study App; and
- transmit or communicate any data that is unlawful, harmful, threatening, abusive, harassing, defamatory, vulgar, obscene, invasive of another’s privacy, hateful or racially, ethnically or otherwise objectionable.
- Participant Data
The primary purpose of the Study App is to collect data about you and/or your health when you agree to participate in a remote patient study. The Study App may collect four different types of data about you, which collectively we call “Participant Data”:
- data and information collected by the Study App from your phone or similar device (example: your movement may be tracked by the Study App using your phone’s accelerometer or gyroscope);
- data and information collected by the Study App itself (example: anonymized responses by you and other Participants to questions in a Study App);
- data and information collected by the Study App from a third party FDA-listed medical device, consumer wearable device, health application, or similar device, wearable, or tool (example: your data may be collected by the Study App when you give permission for it to connect with your Fitbit); and
- data and information entered by the investigator of a remote patient study into the THREAD web portal.
You agree that the Study App may be used to transmit, collect, access, manage, and display Participant Data in anonymized form from you to THREAD, as well as to the principal investigator of a clinical study , authorized partners, or sponsors or research institutions of the remote patient study, and their respective employees and contractors who may access such Participant Data in anonymized or identifiable form. Our authorized partners and sponsors are universities, clinical research organizations, and companies in the areas of pharmaceuticals, biopharmaceuticals, technology consulting, media, health information technologies, clinical research, SaaS for clinical trials, and consumer goods. Depending on the nature of the study, the data collected by the Study App may be based on passive observation methods or active intervention where a participant agrees to intentionally change his or her behavior.
You agree that Participant Data related to your participation in a remote patient study may be stored solely in anonymized form by THREAD and/or its licensees and service providers in connection with providing the Study App and its related services, as well as, where necessary in the performing of THREAD's services, shared among other users of the Study App and its related services. You agree that the Participant Data stored by THREAD shall not serve as the system of record for any patient, personal representative of a patient, health care provider, any business associate of a health care provider, or any affiliates of the foregoing. You understand and agree that the THREAD web portal allows an authorized partner or sponsor or research institution to access and analyze Participant Data collected from the Study App. Your consent is required prior to disclosing any identifiable Participant Data, and will only be made available to those partners or sponsors to whom you provide consent.
- Medical Advice and Treatment
THREAD does not provide medical advice, diagnosis, or treatment. You agree that the Study App is merely a tool to allow the collection and analysis of certain data and information from Participants in support of a clinical study. During the course of a clinical study, the Study App may be used along with the provision of healthcare to patients by independent third party healthcare providers including physicians, physician assistants, nurses, healthcare systems, healthcare facilities, or other providers of healthcare services (collectively, “Healthcare Provider(s)”). You agree that the Healthcare Providers are solely responsible for and will have complete responsibility and control over the provision of all medical services, advice, instructions, treatment decisions, and other professional health care services performed.
You further agree that THREAD does not provide or endorse any medical advice on or through the Study App and no information obtained through the Study App can be so construed or used. THREAD will have and exercise absolutely no control, authority, or supervision over the provision of any medical services or other professional health care services. THREAD will make all reasonable efforts in accordance with applicable laws and agreements to protect the integrity and availability of the Study App, and have implemented robust administrative, logical and physical controls to ensure the confidentiality, integrity and availability of the data provided on or made available through the Study App. Further, when using the Study App, information may be transmitted over a medium that may be beyond the control and jurisdiction of THREAD and its suppliers. Accordingly, THREAD assumes no liability for or relating to the delay, failure, interruption, or corruption of any data or other information transmitted in connection with use of the Study App that is reasonably determined to be beyond THREAD’s control.
- Third Party Technology
Any and all third party technology and third party websites provided, made available, linked to, or otherwise accessible through the Study App (“Third Party Technology”) is provided solely as a convenience to you and is not under the control of THREAD. THREAD does not endorse, recommend, or otherwise make any representations or warranties with respect to any Third Party Technology. You agree to comply with any and all terms and conditions applicable to the use of Third Party Technology.
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- Collection of Information
You grant THREAD the perpetual, non-exclusive, worldwide, sublicensable, royalty-free, irrevocable license to use, copy, print, display, reproduce, modify, publish, post, transmit, distribute, transfer, exploit and preserve any transmittal, communication, or other content provided by you through the Study App, or any other service offered on or through the Study App, and data related to your use of the Study App in anonymized form as necessary for its performance of THREAD's services.
You agree that THREAD may disclose any such content, in anonymized or identifiable form, to other users of the Study App, THREAD’s licensees, service providers, customers, researchers, sponsors, academic institutions and other third parties who shall have the right to use, transfer and exploit such information and content in any manner permitted in accordance with applicable laws.
All content and data collected through the Study App shall remain in anonymized form, and THREAD or its partners, affiliates and third party service providers will not re-identify the information in any capacity. Information containing any personal identifiable information, including name, profile, and biography, or protected health information will never be used, stored, disclosed, copied, printed, displayed, published, posted, transmitted, distributed, or preserved in any form by THREAD unless it is anonymized.
- Authorized Use
Except as stated elsewhere in this Agreement, you will keep the Study App confidential and will not give anyone else access to it. Any rights you may have in the Study App expire upon expiration or termination of this Agreement. You will employ use security measures necessary to prevent unauthorized users from accessing the Study App including your user ID(s) and password(s) (“Login Information”). You are responsible for all access to and use of the Study App in connection with your Login Information.
- Export Law Assurances
You will not use or otherwise export or re-export this Study App except as authorized by United States law and the laws of the jurisdiction in which the Study App was obtained. In particular, but without limitation, the Study App will not be exported or re-exported (1) into (or to a national or resident of) any U.S. embargoed countries, or (2) to anyone on the U.S. Treasury Department’s list of Specially Designated Nationals or the U.S. Department of Commerce Denied Persons’ List or Entity List. By using the Study App, you represent and warrant that you are not located in, under control of, or a national or resident of any such country or on any such list.
Presently, the Study App is available to residents of the United States and Canada only. You agree that you may not sign up for, access or attempt to access or use the Study App from countries outside of the United States and Canada. THREAD may use technologies to verify your compliance.
Trademarks, service marks, graphics and logos used in connection with the Study App are the trademarks of their respective owners. THREAD™, eDRO™ and the trademarks related to the Study App are trademarks of THREAD. You are not granted any right or license with respect to any of the trademarks mentioned above and any use of such trademarks.
- Copyright Infringement
THREAD respects copyright and other laws. THREAD requires all Study App users to comply with copyright and other applicable Laws. As a condition to use the Study App, you agree that you must not use the Study App to infringe upon the intellectual property or other rights of others in any way. The unauthorized reproduction, distribution, modification, public display, communication to the public or public performance of copyrighted works is an infringement of copyright. In the event you fail to comply with such laws, you may be exposed to civil and criminal liability, including possible fines and jail time.
- Ownership and Title
All title to and the rights in the Study App, any derivatives, and all associated goodwill are the exclusive property of THREAD and/or third parties.
- Representations & Warranties
In addition to the other representations and warranties contained in this Agreement, you further represent, warrant, and covenant to THREAD the following:
- All information you provide to THREAD as part of the registration process or otherwise will be truthful, accurate and complete, even if THREAD does not independently verify your information;
- Your use of the Study App will comply with all applicable laws and regulations within the United States and Canada, as applicable;
- You are legally authorized in accordance with applicable laws and regulations to provide any and all Participant Data that you provide to the Study App for all uses contemplated under this Agreement; and
- You represent that you have full power, capacity and authority to enter into this Agreement and understand and accept its terms.
- Disclaimer of Warranties
THE STUDY APP, AND ANY THIRD PARTY TECHNOLOGY ARE PROVIDED ON AN “AS IS” AND “AS AVAILABLE” BASIS WITHOUT WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF TITLE, NON-INFRINGEMENT, AND IMPLIED WARRANTIES OF MERCHANTABILITY, MERCHANTABLE QUALITY OR FITNESS FOR A PARTICULAR PURPOSE.
- Limitation of Liability
EXCEPT WHERE PROHIBITED BY LAW, UNDER NO CIRCUMSTANCES WILL THREAD BE LIABLE TO YOU OR ANY OTHER PERSON FOR DIRECT, CONSEQUENTIAL, SPECIAL, INDIRECT, INCIDENTAL, PUNITIVE, OR EXEMPLARY DAMAGES, COSTS, EXPENSES OR LOSSES OR LOST PROFITS IN CONNECTION WITH THE STUDY APP OR OTHERWISE RELATED TO THIS AGREEMENT.
THE PROVISIONS OF THIS SECTION WILL APPLY REGARDLESS OF THE FORM OF ACTION, DAMAGE, CLAIM, LIABILITY, COST, EXPENSE, OR LOSS, WHETHER IN CONTRACT, STATUTE, TORT (INCLUDING NEGLIGENCE), FAILURE OF ESSENTIAL PURPOSE OR OTHERWISE, AND EVEN IF ADVISED OF THE LIKELIHOOD OF SUCH DAMAGES. THREAD WILL NOT BE LIABLE FOR ANY FAILURE TO PERFORM ITS OBLIGATIONS UNDER THIS AGREEMENT BECAUSE OF CIRCUMSTANCES BEYOND ITS CONTROL, WHICH CIRCUMSTANCES INCLUDE NATURAL DISASTER, TERRORISM, THIRD PARTY LABOR DISPUTES, WAR, DECLARATIONS OF GOVERNMENTS, TRANSPORTATION DELAYS, FAILURE OF HARDWARE, EQUIPMENT, OR TELECOMMUNICATIONS FAILURE. THREAD WILL NOT BE LIABLE FOR ANY FAILURE TO PERFORM ITS OBLIGATIONS UNDER THIS AGREEMENT BECAUSE OF YOUR MISUSE OF THE STUDY APP BY YOU OR ANY OTHER PERSON.
THIS SECTION WILL BE GIVEN FULL EFFECT EVEN IN THE EVENT THAT ANY EXCLUSIVE REMEDY PROVIDED HAS FAILED OF ITS ESSENTIAL PURPOSE. FURTHER, IN NO EVENT WILL THREAD BE LIABLE TO YOU OR ANYONE ELSE FOR ANY CLAIMS, LOSSES, OR DAMAGES ARISING OUT OF ANY USE OR MISUSE OF ANY THIRD PARTY TECHNOLOGY. THE PARTIES ACKNOWLEDGE THAT THE TERMS OF THIS SECTION REFLECT THE ALLOCATION OF RISK SET FORTH IN THIS AGREEMENT AND THAT THE PARTIES WOULD NOT ENTER INTO THIS AGREEMENT WITHOUT THESE LIMITATIONS OF LIABILITY. IN NO EVENT SHALL THE LIABILITY OF THREAD FOR ANY LOSS RELATED TO USE OR INABILITY TO USE THE STUDY APP EXCEED $20.00 U.S.
NOTHING IN THIS SECTION OR AGREEMENT IS INTENDED TO, OR WILL BE INTERPRETED TO, GIVE UP ANY LEGAL RIGHT THAT YOU HAVE AS A CLINICAL RESEARCH SUBJECT.
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IN THE EVENT THAT YOU HAVE A DISPUTE FOR ANY REASON WITH THE RESEARCHER, SPONSOR, OR ACADEMIC INSTITUTION CONDUCTING THE REMOTE PATIENT STUDY FOR WHICH THE STUDY APP IS UTILIZED, YOU RELEASE THREAD (AND ITS OFFICERS, DIRECTORS, MANAGERS, MEMBERS, AGENTS, SUBSIDIARIES, REPRESENTATIVES, AND EMPLOYEES) FROM ALL CLAIMS, DEMANDS AND DAMAGES (ACTUAL AND CONSEQUENTIAL) OF EVERY KIND AND NATURE, KNOWN AND UNKNOWN, SUSPECTED AND UNSUSPECTED, DISCLOSED AND UNDISCLOSED, ARISING OUT OF OR IN ANY WAY CONNECTED WITH SUCH DISPUTES. IF YOU ARE A CALIFORNIA RESIDENT, YOU WAIVE CALIFORNIA CIVIL CODE §1542, WHICH PROVIDES: “A GENERAL RELEASE DOES NOT EXTEND TO CLAIMS WHICH THE CREDITOR DOES NOT KNOW OR SUSPECT TO EXIST IN HIS FAVOR AT THE TIME OF EXECUTING THE RELEASE, WHICH IF KNOWN BY HIM MUST HAVE MATERIALLY AFFECTED HIS SETTLEMENT WITH THE DEBTOR.”
NOTHING IN THIS SECTION OR AGREEMENT IS INTENDED TO, OR WILL BE INTERPRETED TO, GIVE UP ANY LEGAL RIGHT THAT YOU HAVE AS A CLINICAL RESEARCH SUBJECT.
Unless otherwise terminated by THREAD as provided for in this Agreement, this Agreement will remain in effect for so long as THREAD licenses the use of the Study App to you.
THREAD may, in its sole discretion and without prior notice, terminate your access to the Study App for violations of this Agreement or other agreements or guidelines, which may be associated with your use of the Study App, or if THREAD deems it necessary in its sole discretion. Further, the researcher, sponsor, or academic institution conducting the remote patient study may terminate, or request that THREAD terminate your access to the Study App. In any such event, you must de-install or destroy all copies of the Study App and all of its component parts. Failure to abide by this Agreement is a material breach of this Agreement for which THREAD may pursue all rights and remedies it has pursuant to this Agreement, and any other rights and remedies it may have at law or in equity. You also agree that any violation by you of this Agreement will constitute an unlawful and unfair business practice and will cause irreparable harm to THREAD, for which monetary damages would be inadequate, and you consent to THREAD obtaining any injunctive or equitable relief that THREAD deems necessary or appropriate in such circumstances without the need to post a bond or satisfy any similar requirements. These remedies are in addition to any other remedies THREAD may have at law or in equity.
- U.S. Government End Users
The Study App is a “commercial item” as that term is defined at FAR 2.101, consisting of “commercial computer software” and “commercial computer software documentation” as such terms are used in 48 C.F.R. 12.212 and is provided to the U.S. Government only as a commercial end item. Consistent with FAR 12.212 and DFARS 227.7202, all U.S. Government End Users acquire the Study App with only those rights expressly set forth in this Agreement.
- General Provisions
- Assignment. This Agreement, and any rights or obligations in this Agreement will not be assigned by you without the prior written consent of THREAD. Any attempt to assign or transfer this Agreement other than in accordance with this provision will be null and void. Subject to the forgoing, this Agreement and its terms and provisions inure to the benefit of and are binding upon the parties and their respective successors, heirs, personal representatives, and assigns.
- Governing Law/Waiver of Trial by Jury.
- You agree that all matters relating to your access to or use of the Study App, including all disputes, will be governed by the laws of the United States and by the laws of the State of California without regard to its conflicts of laws provisions. You agree to the personal jurisdiction by and venue in the state and federal courts in Orange County, California. This Agreement will not be governed by the United Nations Convention on Contracts for the International Sale of Goods, the application of which is expressly excluded. If for any reason a court of competent jurisdiction finds any provision, or portion of any provision, to be unenforceable, the remainder of this Agreement will continue in full force and effect.
- EXCEPT WHERE PROHIBITED BY LAW, THE PARTIES EXPRESSLY WAIVE TRIAL BY JURY IN ANY JUDICIAL PROCEEDING INVOLVING ANY DISPUTE, CONTROVERSY, OR CLAIM ARISING OUT OF OR RELATING TO THIS AGREEMENT.
- Notices. All notices, requests, or consents sent to THREAD that are required or permitted under this Agreement must be in writing (including electronic form) and must be delivered to the address designated below in a notice served in the manner provided for below. Each notice, request, consent, or other communication will be given and will be effective: (1) if delivered by hand, when so delivered; (2) if delivered by nationally recognized overnight courier service or sent by United States Express Mail, upon confirmation of delivery; (3) if delivered by certified or registered mail, on the third following day after deposit with the United States Postal Service; or (4) if delivered by email, upon confirmation of receipt by the other party in writing by return email.
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- Severability. The provisions of this Agreement are severable. The invalidity, in whole or in part, of any provision of this Agreement will not affect the validity or enforceability of any other of its provisions. If one or more provisions of this Agreement are declared invalid or unenforceable, the remaining provisions will remain in full force and effect and will be construed in the broadest possible manner to effectuate the purposes of this Agreement.
- Captions. The headings and captions of this Agreement are inserted for reference convenience and do not define, limit, or describe the scope or intent of this Agreement or any particular section, paragraph, or provision of this Agreement. Unless otherwise expressly provided, the words “include(s),” “included,” or “including” do not limit the preceding words or terms. Pronouns will refer to the masculine, feminine, neuter, singular, or plural as the context will require.
- Waiver. The failure or delay of THREAD to exercise or enforce any rights or provision of this Agreement does not constitute a waiver of such right or provision.
- Survival. All provisions which must survive in order to give effect to their meaning will survive any expiration or termination of this Agreement, including without limitation, Sections 2(b), 16, 17, 18 and 19 and all of your representations, warranties and indemnification obligations, which will survive any expiration or termination of this Agreement indefinitely.
- Nothing in this section or Agreement is intended to, or will be interpreted to, give up any legal right that you have as a clinical research subject.
Last Updated August 22, 2019.