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Clin’form Solution and Services – Terms and Conditions of Use

The mission of KAYENTIS (referred to as “KAYENTIS”, “we” or “us”) is to provide electronic Clinical Outcome Assessment (“eCOA”) and other related services to study pharmaceutical industry sponsors or Clinical Research Organization (CRO), conducting clinical trials.

Performing the eCOA Services in connection with a clinical trial in which you are interested (the “Clinical Study”), KAYENTIS needs to license its Mobile and/or Web-based applications (collectively referred as “Clin’form App”) to you. Clin’form App enable you to participate or contribute to the Clinical Study conducted by a clinical study sponsor (the “Sponsor”).

These Mobile and Web-based applications Terms and Conditions of Use (hereafter “TCU”) shall form a legal agreement between KAYENTIS and you, the individual user (referred to as “you” and “your”) concerning your access to and use of the Clin’form App, accessible on app stores (Google store or Apple store), on an electronic device (smartphone or tablet) provided by your study team, or at the dedicated web address (URL) provided by KAYENTIS and any related services provided by KAYENTIS.

KAYENTIS’ role is limited to making Clin’form App available to you. We are independent from the Sponsor, the healthcare providers, and other personnel who have designed the clinical Study. We will provide you with Clinical Study related services through this Clin’form Appl. KAYENTIS is not responsible for and has no liability for such healthcare providers’ personnel’s acts, omissions, or for any content of the communications made by them. By providing Clin’form App, KAYENTIS is not providing medical or health advice or services.

Mobile or Web-based Applications access

You are provided access to Clin’form App in order to facilitate your participation in a Clinical Study. The use of Clin’form App constitutes your acceptance of these TCU. You must not use Clin’form App if you disagree with any of these TCU, and refer to your study contact person to evaluate the impact on your eligibility to participate in that Clinical Study.

Clin’form App access is allowed 24 hours a day and 7 days per week, unless in case of force majeure, possible breakdowns or any operation of maintenance necessary for good running of Clin’form App.

Access to the Clin’form App is open to adults. Any use of Clin’form App by a minor must be carried out under the full responsibility of the minor’s parental authority or relevant legal guardian.

To access the Clin’form App, you need a computer or other device that allows for adequate access to the Internet. You understand and agree that Clin’form App, like most other Internet software and services, may be subjected to security issues. KAYENTIS is not responsible for, and cannot ensure, the security of any data transmission made by you or your mobile device using unsecured Internet connections. You accept the inherent security implications of using the application, and we advise you to take all necessary precautions to protect yourself against viruses and piracy, in particular by adopting a secure and adapted computer configuration, through the implementation of regularly updated virus detection software.

In case KAYENTIS provides you with a set of equipment, including a device, smartphone or tablet, to access the Clin’form App, this “Provided Device” is entrusted to you to be used solely for the purpose of the Clinical Trial. It remains the exclusive property of KAYENTIS and must be returned in good standing at the end of the trial or upon request. Any attempt to modify, decrypt, or use this Provided Device in an unauthorized manner, including disassembling parts such as the battery or SIM card, is strictly prohibited and may result in legal action.

Your use of the Mobile or Web-based Applications

In exchange for your agreement with these TCU, we are giving you personally the right to use the Clin’form App and you may:

  • Download a copy of Clin’form App onto your mobile device and view, use and display Clin’form App on such device for your personal purposes only;
  • Browse and display web version of Clin’form App on personal computer for your personal purposes in connection with clinical study tasks only;
  • Receive and use any further released updates of Clin’form App incorporating corrections of errors that we make available.

Clin’form App requires you to create a Password or a PIN code. This information is personal and confidential. You must take all the necessary steps to prevent unauthorized access to your account (using complex password, not using the same password on different services…).

You are responsible and liable for all actions taken under your account. If you become aware or suspect that your account or access credentials have been compromised by an unauthorized third party, you must inform us immediately and to take immediate measures, such as changing your Password or PIN code.

Updates and changes to Clin’form App

From time to time, we may automatically update or change Clin’form App to enhance functionality, reflect changes to the operating system, improve performance, or address security issues.  Alternatively, we may ask You to update Clin’form App on your device.

If you decline the installation of such updates or changes, you may not be able to continue using Clin’form App. We recommend that you regularly check for updates and promptly install them to ensure optimal performance and security of the application.

Your Privacy

We use any personal information you provide through your use of Clin’form App in the ways described in our Privacy Policy. Please read our Privacy Policy: https://kayentis.com/clinform-policy/privacy-policy/

If you download on your own mobile the version of the Clin’form App from an app store, the terms and conditions, and privacy policy of such app store may apply to you. We encourage you to read the terms and conditions, and privacy policy of the relevant app store you use to download Clin’form App to understand their terms and how they use your personal information.

Intellectual Property Rights

Other than the content you own, all information and content on Clin’form App is the property of KAYENTIS . The content is protected by copyright laws and trademark. Any unauthorized use of the content will be considered a violation of Kayentis’ intellectual property rights. Unless otherwise stated in this document, no content may be copied, distributed, published or used in any way, in whole or in part, without prior written agreement from Kayentis, except as allowed by the limited license granted hereafter, only for purposes of viewing the material contained on Clin’form App.

KAYENTIS trademarks and logos appearing on Clin’form App, except as otherwise noted, are trademarks owned or used under license by KAYENTIS or its affiliates in the geographic regions where Kayentis markets products bearing such trademarks. The use or misuse of these trademarks or any other content on this site, except as provided in these TCU or in the content, is strictly prohibited.

Restrictions

You are specifically restricted from all of the following:

  • Using this Clin’form App in any way that is or may be damaging to Clin’form App or that impacts user access to Clin’form App
  • Selling, sublicensing, making available to any third party and/or otherwise commercializing any Clin’form App features or functionalities
  • Publicly performing, publishing or showing any Clin’form App material without KAYENTIS authorization
  • Using these Clin’form App contrary to applicable laws and regulations, or in any way that may cause harm to any person or business entity
  • Engaging in any data mining, data harvesting, data extracting or any other similar activity in relation to Clin’form App
  • Reverse engineer, disassemble, decompile, or otherwise attempt to gain access to the source code of the software.

Certain areas of Clin’form App are restricted from being accessed by you and KAYENTIS may further restrict access by you to any areas of Clin’form App, at any time, in absolute discretion.

Termination

You may terminate these TCU by ceasing to access and use Clin’form App.

If you violate these TCU, your ability to use Clin’form App will be terminated, without prejudices to any other right or remedy we may have available at law.

We may terminate these TCU at any time without notice, for any or no reason.

Upon termination, the rights granted to you under these TCU will also terminate. You will stop all use of Clin’form App and delete the app from your mobile device and we will remove your access rights.

No warranties

CLIN’FORM APP IS PROVIDED TO YOU “AS IS,” AND WITH ALL FAULTS AND DEFECTS WITHOUT WARRANTY OF ANY KIND. TO THE MAXIMUM EXTENT PERMITTED UNDER APPLICABLE LAW, KAYENTIS EXPRESSLY DISCLAIMS ALL WARRANTIES, WHETHER EXPRESS, IMPLIED, STATUTORY, OR OTHERWISE, WITH RESPECT TO CLIN’FORM APP, INCLUDING ALL IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE, AND NON-INFRINGEMENT, AND WARRANTIES THAT MAY ARISE OUT OF COURSE OF DEALING, COURSE OF PERFORMANCE, USAGE, OR TRADE PRACTICE.

WITHOUT LIMITATION TO THE FOREGOING, KAYENTIS PROVIDES NO WARRANTY OR UNDERTAKING, AND MAKES NO REPRESENTATION OF ANY KIND THAT CLIN’FORM APP WILL MEET YOUR REQUIREMENTS, ACHIEVE ANY INTENDED RESULTS, BE COMPATIBLE, OR WORK WITH ANY OTHER SOFTWARE, APPLICATIONS, SYSTEMS, OR SERVICES, OPERATE WITHOUT INTERRUPTION, MEET ANY PERFORMANCE OR RELIABILITY STANDARDS, OR BE ERROR-FREE, OR THAT ANY ERRORS OR DEFECTS CAN OR WILL BE CORRECTED.

NOT WITHSTANDING THE FOREGOING, NOTHING IN THESE TERMS AND CONDITIONS SEEKS TO EXCLUDE OR LIMIT EITHER PARTY’S LIABILITY TO THE OTHER FOR DEATH OR PERSONAL INJURY CAUSED BY NEGLIGENCE, FRAUD OR FRAUDULENT MISREPRESENTATION, OR FOR OTHER LIABILITY WHICH CANNOT BE LIMITED OR EXCLUDED BY APPLICABLE LAWS.

Limitation of liability

TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, IN NO EVENT WILL KAYENTIS HAVE ANY LIABILITY ARISING FROM OR RELATED TO YOUR USE OF OR INABILITY TO USE CLIN’FORM APP OR THE CONTENT AND RELATED SERVICES FOR:

PERSONAL INJURY, PROPERTY DAMAGE, LOST PROFITS, COST OF SUBSTITUTE GOODS OR SERVICES, LOSS OF DATA, LOSS OF GOODWILL, BUSINESS INTERRUPTION, COMPUTER FAILURE OR MALFUNCTION, OR ANY OTHER CONSEQUENTIAL, INCIDENTAL, INDIRECT, EXEMPLARY, SPECIAL, OR PUNITIVE DAMAGES.

THE FOREGOING LIMITATIONS WILL APPLY WHETHER SUCH DAMAGES ARISE OUT OF BREACH OF CONTRACT, TORT (INCLUDING NEGLIGENCE), OR OTHERWISE AND REGARDLESS OF WHETHER SUCH DAMAGES WERE FORESEEABLE OR KAYENTIS WAS ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. SOME JURISDICTIONS DO NOT ALLOW CERTAIN LIMITATIONS OF LIABILITY SO SOME OR ALL OF THE ABOVE LIMITATIONS OF LIABILITY MAY NOT APPLY TO YOU.

Indemnification

You hereby agree to indemnify to the fullest extent KAYENTIS from and against any and/or all liabilities, costs, demands, causes of action, damages and expenses arising in any way from or related to your breach of any of the provisions of these TCU, to your use or misuse of Clin’form App.

Severability

If any provision of these TCU is found to be invalid under any applicable law, such provisions shall be deleted without affecting the remaining provisions herein.

Variation of Terms of Use

KAYENTIS is permitted to change Clin’form App, to revise or develop these TCU at any time as it sees fit. Any such changes will come into effect as soon they are activated on Clin’form App. Therefore, KAYENTIS encourages Users to regularly consult Clin’form App and the TCU.

Assignment

KAYENTIS is allowed to assign, transfer, and subcontract its rights and/or obligations under these TCU without any notification. However, you are not allowed to assign, transfer, or subcontract any of your rights and/or obligations under these TCU.

Entire Agreement

These TCU constitute the entire agreement between KAYENTIS and you in relation to your use of Clin’form App and supersede all prior agreements and understandings.

Waiver

No failure to exercise, and no delay in exercising, on the part of either party, any right or any power hereunder shall operate as a waiver thereof, nor shall any single or partial exercise of any right or power hereunder preclude further exercise of that or any other right hereunder.

Governing Law & Jurisdiction

These TCU will be governed by and interpreted in accordance with the laws of France, and you submit to the non-exclusive jurisdiction of the Tribunal de Grenoble, France.

Legal Notice

  • Site editor

Site owner: KAYENTIS –  contact@kayentis.com – +33 (0)4 76 00 54 20
Company identification: KAYENTIS SAS registered under number RCS 451 664 809 Grenoble – Headquarter at: 19 bis, chemin du vieux Chêne – 38240 Meylan – France

  • Publishing director

Mr. Guillaume Juge, acting as Chief Executive Officer of the company –  contact@kayentis.com 

  • Data Protection Officer

Ms Florence Laverny-Rafter –  dpo@kayentis.com

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The provider of hosting services is:
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Microsoft France is part of Microsoft Corporation, 1 Microsoft Way, 98052 Redmond, Washington, USA.