By using this software application ("App") which may also be referred to as the "REPLACE TRIAL App" you as the participant ("Participant", "you", "your") in this Phase III Clinical Trial ("Trial") agree to these Terms and Conditions of Use of the App ("Terms"). If you do not agree to all of these Terms, do not use this App. The App is not required for your participation in the Trial, but it should very much ease your participation by providing a convenient method to complete three (3) recurring questionnaires during the Trial to provide feedback about various aspects of your health status and quality of life, and to keep track of your treatment if applicable.
You are eligible to establish an account on the App to facilitate your participation in the Trial as a Participant because you are a diagnosed cancer patient who has agreed to do so in consultation with your health care professional/physician ("Physician" or "Investigator"), and the App is intended to facilitate your participation.
As part of establishing your account, you will be required to provide your Patient ID number assigned to you in the Trial. This unique number will be used to link your account information to your assigned treatment, your Physician and the site where you are being treated and will help to preserve your privacy and confidentiality. Information you provide to your physician through the App is entirely anonymized; identities of the Participants are protected by the Trial and the Trial sponsor as more fully set out in the Privacy Policy. Once you agree to the terms for using the App, please enter your email address and a password that you choose, and at that point you will have met all requirements to establish a Participant account. Your email address and password are stored on a server separate from any of the Trial information that you log, to preserve your privacy. Only Treatment Technologies and Insights, Inc. will have access to your email and password, so that your password can be replaced if you lose or forget it, or to provide you with notifications to remind you about trial related activities and/or any troubleshooting or support that you request.
To establish your account, you will be asked to agree to the Terms and Conditions for using the App, the Privacy Policy, and a request for your Consent to share information you provide as part of your participation in this trial with physicians and study coordinators at the site where you are being treated, as well as the Trial sponsor. You have the right to withdraw your Consent at any time. You also have the right to use paper instead of the App to complete the required questionnaires and if applicable keep track of your Regorafenib intake.
All content contained in the App, including, but not limited to, all text, graphics, images, outcomes, patient profiles, information from any third parties, and any other material or data contained in the App (collectively, "Content"), is for informational purposes only. Neither the Content nor any services you may access through using the App ("Services") are intended to be a substitute for professional medical advice, diagnosis, or treatment. The App collects and organizes your input about medical treatment, dosage and timing, and questionnaire responses. It provides you with no medical diagnoses or advice. Historically such information was collected as a paper diary or journal, but the App is more efficient and when used properly it should enhance the Trial's efficiency. However, you should always seek the advice of your Physician or other qualified health provider with any questions you may have regarding your health or treatment. Never disregard professional medical advice or delay in seeking it because of something you may have read on the App.
This App is provided by Treatment Technologies & Insights, Inc. ("TTI"). TTI does not recommend or endorse any specific tests, physicians, products, procedures, opinions, or other information that may be contained in the App. Reliance on any information provided by TTI or TTI employees is solely at your own risk.
You should not upload any information to the App that is or could be construed as being: (a) false, inaccurate or misleading; (b) infringing upon any copyright, patent, trademark, trade secret or other proprietary rights or rights of publicity or privacy of any party; or (c) defamatory, libelous, threatening, abusive, hateful, obscene or pornographic. You represent and warrant that the information you provide when registering as a Participant (as defined below), and all Information that you subsequently provide regarding your health, activities and treatment experiences, is accurate and not misleading.
The App and the Content provided by TTI in the App are protected by copyright laws in the United States and in all countries in which the Trial has Participants as well as by international treaties. Title to the App and Content remains with TTI and its licensors. You agree not to remove any copyright or trademark notices of TTI or any other proprietary notices, and not to otherwise violate any of the copyright, trademark or other intellectual property rights of TTI and its licensors in the App and the Content. Any special rules or instructions for the use of certain software and other items accessible on the App may be included elsewhere within the App and are incorporated into these Terms by reference. App Content and features are subject to change or termination without notice in the editorial discretion of TTI. All rights not expressly granted herein are reserved to TTI and its licensors.
If you violate any of these Terms, your permission to use the App automatically terminates and you must immediately destroy any copies you have made of any portion of the Content.
You, the data subject, own all of your personal data/personally identifiable information as defined in applicable data privacy laws. You also own the medical information logged by you, including notes and questionnaire responses, and this information may also be regulated as Personal Health Information or "PHI" under applicable US law, and also may be regulated under the laws of other countries where Participants reside. Everything you input into the App related to the Trial, including any notes you input and questionnaire responses, constitutes "Information." You grant the Trial and its sponsor the worldwide right to use this Information for any and all purposes in connection with the Trial, for such time period as is deemed necessary by the Trial sponsors, on an anonymized basis or otherwise with adequate privacy restrictions as indicated in these Terms and the Privacy Policy, and also to your Physician to use the Information in your treatment and as part of the Trial. TTI is granted the same rights by you as are required to support the App, the Trial and its sponsors' use as described above. Personal data/Information submitted to the App will be collected, processed, stored, disclosed and disposed of in accordance with applicable law and the App's Privacy Policy.
You may not use any robot, spider, scraper, or other automated means to access the App for any purposes. You may not post Information or anything else on the App that contains any viruses, Trojan horses, worms, time bombs, spiders, or other computer programming routines that are intended to damage, detrimentally interfere with, surreptitiously intercept or misappropriate any system, data or personal information. You shall not attempt to make the App unavailable through denial-of-service attacks or similar means.
The App and all Content contained therein are for your personal use only in connection with the Trial and may not be used in connection with any commercial or other endeavors. You may not publicly display, distribute, publish or otherwise disseminate the App or any Content contained therein, or any of your Information, without TTI's prior written consent.
Subject to these Terms, TTI and the Trial sponsors are committed to protecting the confidentiality of your Information in accordance with applicable privacy, data protection and medical records laws such as GDPR, HIPAA, and also subject to the Privacy Policy. Your Information will be used only for the purpose set forth herein, and TTI shall employ adequate safeguards and technical and organizational measures in accordance with such requirements.
Please review the App's Privacy Policy ("Privacy Policy") for more information on how TTI collects, uses and shares App user data/Information. By using the App, you agree that you have read, understood and accept the terms of the Privacy Policy also.
If you are a copyright owner or an agent thereof and believe that any Content infringes upon your copyright, you may submit a written notification at least under US law pursuant to the Digital Millennium Copyright Act, which modified the US Copyright Act ("DMCA") by providing our Copyright Agent (listed below) with the following information: (i) an electronic or physical signature of a person authorized to act on behalf of the owner of an exclusive right that is allegedly infringed; (ii) a description of the copyrighted work claimed to have been infringed or if multiple copyrighted works are covered by a notification, a representative list of such works at our App; (iii) a description of the location on the App of the allegedly infringing material(s); (iv) your address, telephone number, and email address; (v) a written statement that you have a good faith belief that use of the material(s) in the manner complained of is not authorized by the copyright owner, its agent, or the law; and (vi) a written statement that the information in the notification is accurate, and under penalty of perjury, that you are authorized to act on behalf of the owner of an exclusive right that is allegedly infringed. If Information you submitted has been removed as a result of a notification as described above and you believe that such Information or portion of Information was posted lawfully, please contact us about our counter-notification procedure through which you can dispute the allegation and request re-posting of the Information at issue. All notices of alleged copyright infringement and requests about the counter-notification procedures should be directed to TTI's Copyright Agent at REPLACETrial@tti.care. You acknowledge that if you fail to comply with all of the notice requirements under the DMCA, your notice may not be deemed valid.
You are responsible for maintaining the security and confidentiality of your login details, and you are solely responsible for all activities that occur under your password or account with or without your knowledge. IF YOU KNOWINGLY PROVIDE YOUR LOGIN AND PASSWORD INFORMATION TO ANOTHER PERSON, YOU DO SO AT YOUR OWN RISK THAT THEY MIGHT SHARE PERSONAL INFORMATION THAT YOU WOULD CONSIDER PRIVATE, AND YOU RISK AFFECTING THE TRIAL ADVERSELY. You agree to immediately notify TTI of any unauthorized use of your account login or password credentials or any other breach of security.
The App does not contain links to other third-party websites or applications that are not under the TTI's ownership or control.
TTI may, with or without cause, immediately terminate your account or limit or terminate your access to your account and/or the App in its sole discretion at any time and without the necessity of notice, including for the following reasons: (a) your breach or violation of these Terms or other incorporated agreements or guidelines, (b) in order to comply with a judicial or other governmental order, or request by law enforcement or other government agency, (c) upon your request (i.e., account cancellation) and/or if you withdraw your consent to the Terms and Conditions, Privacy Policy or Agreement for using the app, (d) unexpected technical issues or problems, (e) extended periods of inactivity indicative of your opting out of the Trial, and (f) completion or termination of the Trial. TTI is not under any obligation to maintain, store, or transfer your Information or data posted on or uploaded to the App upon account termination.
Except for any warranties stated herein, to the maximum extent permitted by applicable law TTI disclaims any and all warranties (whether express, implied, statutory, or otherwise) relating to the app, and any content contained therein or services provided, including, but not limited to, any implied assurances of merchantability or fitness for a particular use or purpose, non-infringement, and any assurances that may arise from course of dealing, course of performance, or usage in trade. Your use of the App, including any of its content or services, is on an "as is" and "as available" basis. TTI does not warrant that access to the app, or any of its content or services, will be uninterrupted or error-free or that all defects will be corrected.
To the maximum extent permitted by applicable law: (1) in no event will TTI be liable for any indirect, punitive, special, incidental or consequential damages in connection with or arising out of your use of the App, or any of its Content or Services (including, without limitation, loss of business, revenue, profits, goodwill, use, data, or other economic advantage), however they arise, whether in breach of contract, breach of warranty or in tort, including negligence and strict liability, even if TTI has previously been advised of the possibility of such damages, and whether or not such damages are foreseeable and (2) TTI's total liability to you hereunder shall not exceed the greater of amounts paid by you for the App, or US $100.00.
TTI will indemnify, defend, and hold you harmless from and against any and all losses, expenses, costs, liabilities, damages, claims, suits, and demands, including attorneys' fees ("Claims") arising from or attributable to any allegation by a third party that the App and/or its Content infringes such third-party's intellectual property rights.
You will indemnify and hold TTI and any parent, subsidiary or affiliate entity, and its and their officers, directors, personnel, attorneys and agents (collectively, "TTI Indemnitees") harmless, and at TTI's request defend TTI Indemnitees, from and against any Claim against any TTI Indemnitee that arises because of your act or omission, or from the Information that you provide to TTI or the App.
Each party agrees to give the other party: (i) prompt notice of any such Claim for which it claims indemnification, (ii) control of the defense and settlement of the Claim if TTI is the indemnifying party, and in the reverse case TTI has the right to give you control if it chooses, and (iii) all available information and necessary assistance with respect to the Claim. The indemnifying party may not compromise or settle such Claim if it is materially averse to the indemnified party without the latter's written consent. TTI shall have no indemnification obligation for any Claim arising from any misuse or unauthorized use of the App, or its Content or Services. Notwithstanding the foregoing, in the event the App, in TTI's opinion, is likely to or does become the subject of a claim of infringement, TTI shall have the right at its sole option and expense to: (a) modify the App and/or Content to be non-infringing while preserving substantially equivalent functionality; (b) obtain for you a license to continue using the App; or (c) terminate these Terms and refund a pro-rated portion of fees you have paid for the App, if any.
As a registered Participant and user of the App, you agree that TTI may send notices to you by email at the email address you provide. Emails from TTI will be for non-marketing purposes such as to provide you with information about the trial or your account, how to use the app, how to reset your password and to provide you with notifications to remind you about trial related activities and/or any troubleshooting or support at your request. Notifications can be disabled through your mobile device's operating system.
Waiver. No failure or delay by either party in exercising any right under the Terms, including the Privacy Policy, will constitute a waiver of that right. No waiver under the Terms or the Privacy Policy will be effective unless made in writing and signed by an authorized representative of the party that would be granting the waiver.
Severability. These Terms, including the Privacy Policy, will be enforced to the fullest extent permitted under applicable law. If any provision of these Terms, including the Privacy Policy, is held by a court of competent jurisdiction to be contrary to law, the provision will be modified by the court and interpreted so as best to accomplish the objectives of the original provision to the fullest extent permitted by law, and the remaining provisions of these Terms or Privacy Policy will remain in effect.
Assignment. You may not assign any of your rights or delegate your obligations under these Terms, whether by operation of law or otherwise, because you are a Participant. We may assign these Terms in their entirety (including all terms and conditions incorporated herein by reference), without your consent, to another entity or affiliate or in connection with a merger, acquisition, corporate reorganization, or sale of all or substantially all of our assets, subject to applicable law.
Governing Law; Venue; Waiver of Jury Trial; Fees. These Terms are governed by the federal and state laws applicable in the State of California, USA, without regard to its provisions on conflicts of laws. Other laws related to your place of residence may also be applicable to these Terms. To the maximum extent permitted by applicable law, (i) you hereby submit to the jurisdiction of the United States District Court for the Central District of California, and to the extent that a matter is instead subject to jurisdiction in state court, to the state courts of competent jurisdiction of Los Angeles County, California, USA, and (ii) you hereby waive any right to jury trial in connection with any action or litigation in any way arising out of or related to these Terms, including the Privacy Policy. In any action or proceeding to enforce rights under these Terms, including the Privacy Policy, the prevailing party shall be entitled to recover all costs and expenses, including, without limitation, its reasonable attorneys' fees.
Entire Agreement. These Terms, inclusive of the Privacy Policy and any terms incorporated by reference into these Terms, constitute the entire agreement between you and TTI and supersede all prior and contemporaneous agreements, proposals or representations, written or oral, concerning its subject matter. To the extent of any conflict or inconsistency between the provisions in these Terms and any terms contained elsewhere within the App, these Terms will take precedence and control, followed by the provisions in referenced terms elsewhere (e.g., the Privacy Policy).
Survival. The sections titled "Acceptable and Lawful Use of the App," "Ownership of the App and Content," "Confidentiality," "Ownership of Information Logged by You," "Disclaimer and Limitation of Liability," "Indemnification," "Notices" and "General" will survive any termination or expiration of these Terms.
TTI may revise and update these Terms at any time, based on modifications to the Trial, changes in applicable laws, or for other valid reason. The "Last Updated" legend at the top of these Terms indicates when these Terms were last revised. We encourage you to review these Terms periodically for any updates or changes. Your continued usage of the App will mean you accept those changes to the extent permitted by appliable law.
If you have any questions or comments, or to report violations of these Terms, please let us know by emailing us at: REPLACETrial@tti.care.