TERMS AND CONDITIONS OF USE

BRAINTALE, a simplified joint stock company with capital of €10,000, with its registered office at 11 rue de l’Académie, 67000 Strasbourg, entered in the Strasbourg Trade and Companies Register under number 840 995 138, and represented by Mr. Vincent Perlbarg, in his capacity as Chairman (hereinafter “BRAINTALE“).

BRAINTALE specializes in research and development in other physical and natural sciences. As part of its activities, BRAINTALE has developed and published the brainTale-care solution, a software platform qualified as a medical device in SaaS (Software as a Service) mode, currently providing access to the brainQuant Module (as defined below) and, where applicable, the brainScore-coma Module (as defined below) (hereinafter referred to as the “Solution“).

A technical description of the Solution is provided by BRAINTALE in the brochure attached in Appendix 2. All rights to the Solution are reserved for BRAINTALE.

The Solution is available and directly accessible in SaaS – Software as a Service format at https://webapp.braintale.fr/brainTale-care/ and/or any suffixes and/or access fields that direct to this address.

These terms and conditions of use (hereinafter the “T&Cs“) constitute mandatory contractual provisions whose purpose is to lay down the terms and conditions for access and use of the Solution, as well as the rights and obligations of Users (as this concept is defined below) in this context.

The Solution is the exclusive property of BRAINTALE. All rights to it are reserved.

USERS SHOULD READ THE T&CS CAREFULLY BEFORE USING THE SOLUTION.

All Users are deemed to have read and accepted the T&Cs.

1. DEFINITIONS

In the T&Cs, capitalized terms and expressions have the meanings set out below, whether used in the singular or plural:

T&Cs: means these terms and conditions of use of the Solution.
Client: means the legal entity taking out the subscription with BRAINTALE, allowing Users to access and use the Solution. The Client is strictly understood to be an establishment, within the legal meaning of the term (identified individually by a SIREN number – main establishment, secondary establishment, subsidiary, branch, site, works council, etc.).
Personal Data: means, within the meaning of the GDPR, any information relating to an identified or identifiable natural person, i.e. a person who can be identified, directly or indirectly, in particular by reference to an identifier, such as a name, an identification number, location data, an online identifier, or to one or more factors specific to their physical, physiological, genetic, mental, economic, cultural or social identity.
Health Data: means, within the meaning of the GDPR, any Personal Data relating to the physical or mental health of a natural person, including the provision of health care services, which reveal information about that person’s state of health. Within the context of use of the Solution, Health Data includes imaging and MRI data of Patients treated within the Client’s healthcare facility.
Data: means collectively the Health Data and the Personal Data.
Data Protection Law: collectively refers to Law No. 78-17 of 6 January 1978 as amended, known as the “French Data Protection Act”, Regulation (EU) No 2016/679 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC, known as the “General Data Protection Regulation” or “GDPR”, as well as any other applicable regulations in this area, which may be added to it or replace it at a later date.
Confidential Information: means any information of a financial, legal, commercial, technical, computer or administrative nature that the Parties may disclose within the framework of the T&Cs, directly or indirectly, in writing, orally, in any form and medium whatsoever due to its nature or the circumstances of its disclosure which should reasonably be considered confidential.
brainTale-care platform: brainTale-care is a medical software device in SaaS mode (web platform) for extracting standardized parameters of magnetic resonance imaging (MRI) of the brain and providing prognostic scores for neurological disorders. brainTale-care offers two analysis modules.
brainQuant module: means the brainQuant module of the braintale-care medical device software for automatic processing of cerebral diffusion magnetic resonance images and the provision of standardized regional diffusion parameters.
brainScore-coma Module: means the brainScore-coma module of the brainTale-care platform, which provides neurological prediction scores related to the development of patients in coma, based on regional standardized diffusion parameters based on brainQuant magnetic resonance images.
Parties: means individually BRAINTALE or the User, and collectively BRAINTALE and the User.
Patient: refers to patients benefiting from healthcare services provided by the Users acting on behalf of the Client, and whose Personal Data, including Health Data, is processed in the context of its use by Users.
Solution: has the meaning given to it in the preamble of this TCS. It is understood that the Solution may change in order to integrate new modules.
User: means any natural person authorized by the Client to access and use the Solution. Thus, Users must be employees, agents or service providers of the Client, and may only access and use the Solution for the purposes of the Client’s activities, in strict compliance with the T&Cs and to the exclusion of any personal use of the Solution on their own behalf.

2. DESCRIPTION OF THE SOLUTION

The Solution is an online software platform that allows registration or connection and depositing of MRI images on said platform.

The Solution gives access, by default, to the brainQuant Module, which allows automatic processing of cerebral diffusion magnetic resonance images and the provision of standardized regional diffusion parameters. The brainQuant module provides the results of regional diffusion parameters in the form of diagrams and parametric maps and videos containing all the results of the processing performed by the brainQuant Module.

The Solution also allows, at the Client’s request, optional access to the brainScore-coma Module, which provides neurological prediction scores related to the development of patients in coma, based on regional standardized diffusion parameters based on brainQuant magnetic resonance images. The brainScore-coma Module provides the prediction score in the form of diagrams and parametric maps containing all the results of the processing performed by the brainScore-coma Module.

The Solution allows:

User registration/identification;
Monitoring of user activity;
The depositing (upload) of an MRI archive in DICOM format;
Automatic creation of a “patient record” from the MRI archive data in the event that the patient record has not already been created;
Viewing and downloading of reports in PDF format;
Viewing and downloading of results and videos;
Contact to be made with BRAINTALE support via the contact form available on the Solution;
Provision of documentation;

The brainQuant Module can be used to:

Calculate and provide regional standardized diffusion parameters based on Diffusion Tensor Imaging (DTI) according to patented technology
Provide MRI image charts, figures and videos enhanced with cerebral quantification measurements
Provide a structured report containing the above information.

The brainScore-coma Module can be used to:

Provide a neurological prediction score
Provide a structured report containing the above information.

As a medical device, the Solution has been designed and developed in accordance with the applicable requirements, in particular Directive 93/42/EC and Regulation (EU) 2017/745 on medical devices and has been certified and has CE conformity marking.

No other object or guarantee is given by BRAINTALE, which the User acknowledges and accepts.

3. ACCEPTANCE OF THE T&CS

The T&Cs constitute an agreement between the User and BRAINTALE. Access to the Solution is subject to the User’s express and unreserved acceptance of the T&Cs. Failure to accept the T&Cs will make it impossible for the User to access and use the Solution.

This acceptance is required before the User first connects to the Solution. The T&Cs are provided after training in the Solution. By signing them, the User acknowledges having read the T&Cs and having understood them, and that he/she fully accepts all of their provisions, without restriction or reservation.

4. CONDITIONS FOR ACCESSING THE SOLUTION

Access to and use of the Solution requires the creation of a User profile. To do this, all Users must have the skills and equipment (computer, software, telecommunication means) necessary to access and use the Solution, as well as a valid email address. The User must be trained to use the Solution before accessing it.

All costs relating to access to and use of the Solution (telecommunications costs, etc.) shall be borne exclusively by the User. The User is solely responsible for the proper functioning of his/her computer equipment as well as for his/her access to the Internet.

The User acknowledges and accepts that use of the Solution is reserved for legally capable adults.

An email is sent to the User so that he/she can connect to the Solution for the first time. This email contains a link allowing the User to access a login page, where he/she will be able to change his/her password.

User names and passwords are strictly personal and confidential and shall not under any circumstances be disclosed or shared with third parties. The User is personally responsible for their keeping them confidential, as well as for all actions, fraudulent or otherwise, that may be carried out under his/her user name and/or password.

The User undertakes to immediately inform BRAINTALE of any suspicion or unauthorized use of his/her account, by email to the dpo@braintale.eu address.

In any event, BRAINTALE reserves the right not to validate the creation, to disable and/or delete any account, following verification with the User concerned, after having requested all useful explanations, if his/her indications are not complete, accurate or precise, or in the event of non-compliance by the User with the provisions of these T&Cs.

5.AVAILABILITY AND OPERATION OF THE SOLUTION

The Solution is accessible 24 hours a day, 7 days a week, except in the case of a force majeure event or an event beyond the control of BRAINTALE, and except in the event of interruption, suspension or limitation within the context of maintenance operations and/or updates necessary for the proper functioning of the Solution.

BRAINTALE is only bound by an obligation of means concerning the accessibility, operation and availability of the Solution or its content. BRAINTALE reserves the right to occasionally interrupt, suspend or limit access to all or part of the Solution, particularly due to legal or technical constraints.

The User expressly acknowledges that the aforementioned suspensions, interruptions or limitations may occur at any time subject to a minimum notice period of forty-eight (48) hours, except in the case of urgent technical intervention, and that they shall not give rise to any obligation or compensation for his/her benefit.

In addition, the User acknowledges and accepts that the Solution exists only to the extent of its technical possibilities.

Accordingly, each User acknowledges that:

BRAINTALE does not guarantee that the Solution will operate without interruption or error,
BRAINTALE does not exercise any control or supervision over the Data, the content and the information created, exchanged, and/or put online using the Solution and cannot be held liable in any way whatsoever in this respect,
BRAINTALE has no control over the use, by Users, of the Solution; consequently, BRAINTALE may not under any circumstances be held liable for the modification or deletion of Data or any other result obtained by using the Solution.

6. USE OF THE SOLUTION

Proper use of the Solution

Given the nature and purpose of the Solution, the User must act as a professional, for the purposes of his/her professional activity, and undertakes to use the Solution exclusively for the purposes of this professional activity carried out on behalf of the Client.

The User undertakes to use the Solution in accordance with the T&Cs and the user manual provided by BRAINTALE, in compliance with its professional and/or ethical obligations and, more generally, with the international, European and national laws and regulations applicable in France.

Since the User is required to process Data in the context of using the Solution, he/she undertakes to comply with the provisions set out in the “Personal Data Protection” article below.

Prohibited behavior

It is strictly forbidden to use the Solution for the following purposes:

the exercise of illegal or fraudulent activities or activities that infringe the rights or security of third parties,
breach of public order or violation of the laws and regulations in force,
the assistance or inducement, in any form and in any manner whatsoever, to one or more of the acts and activities described above,
and, more generally, any practice hijacking the Solution for purposes other than those for which it was designed, or for purposes other than normal use, it being specified that, in particular, any use and activity deemed disproportionate shall be considered as not falling within the scope of normal use.

Moreover, without this list being exhaustive, each User shall refrain from:

publishing, transmitting, disseminating, editing or making accessible on or through the Solution, any content that could constitute, but is not limited to, defamation, insults, disparagement, threats, blackmail, harassment, incitement to violence, racial hatred and, more generally, the commission of crimes and offenses; the spread of information covered by secrecy, content prohibited by law or infringing the rights of third parties; breach of privacy, protection of Personal Data or medical secrecy,
posting, indicating or disseminating in any form whatsoever information or content incorporating links to third-party websites that are illegal and/or contrary to good moral standards,
attempting to mislead other Users by usurping the identity or harming the image or reputation of others,
downloading or falsifying any Data posted to the Solution,
disrupting, slowing down, blocking or altering the normal flow of the Data, modifying or altering or committing any other action having an equivalent disruptive effect on the functionality of the Solution,
posting, indicating or disseminating, in any form whatsoever, information or content that has the effect of reducing, disrupting, preventing the normal use of the Solution, interrupting and/or slowing down the normal circulation of Data and information, deliberately transmitting elements containing viruses, Trojan horses, spyware, or any other program harmful or likely to harm the proper functioning of the Solution,
acting unfairly against BRAINTALE, other Users and Patients, and/or harming, in any way whatsoever, their interests,
dissociating or attempting to dissociate the components of the Solution, and/or reconstituting the logic of the Solution, decompiling it or disassembling it for any reason whatsoever.

Pursuant to the “Responsibility” article below, BRAINTALE may suspend all access and, where applicable, terminate the User’s access to the Solution in the event of non-compliance with this article, and use any technological, legal, operational or other means at its disposal, in order to obtain the forced fulfillment of the T&Cs, including but not limited to blocking IP addresses or deactivating User accounts, without prejudice to any damages that BRAINTALE may claim.

The User’s commitments in use of the Solution

As a manufacturer of medical devices, BRAINTALE is bound by an obligation of post-marketing monitoring of the Solution, under which BRAINTALE must actively and systematically collect, record and analyze relevant data on the quality, performance and security of the Solution throughout its lifetime, so as to be able to define and apply any preventive or corrective measures that may be necessary and to ensure the monitoring of the Solution.

In this context, the User undertakes to communicate to BRAINTALE any information or data relating to an incident, risk of incident or undesirable event that arises in the context of use of the Solution, so as to enable BRAINTALE to comply with its legal and regulatory obligations as a manufacturer of medical devices.

7. GUARANTEES

BRAINTALE expressly guarantees that the Solution is a medical device within the meaning of Article L.5211-1 of the French Public Health Code, with the CE marking, compliant with the requirements of the regulations applicable to medical devices.

In this respect, BRAINTALE guarantees Users the high performance of the Solution.

BRAINTALE guarantees the confidentiality and security of the Data entered and processed by Users on the Solution. BRAINTALE also guarantees, through its host, the physical and logical security of the servers on which the Solution and the Data are hosted.

However, BRAINTALE cannot guarantee the accuracy, completeness, timeliness or other quality of the Data integrated and processed by the User on the Solution, since the User is solely responsible for the accuracy and quality of the Data it processes on the Solution.

The User also ensures that the Data that he/she integrates and processes on the Solution (and which may be attachments) is free of viruses or any other component likely to cause damage to the Solution. In this respect, the User acknowledges that a lack of security, integrity and/or quality of the Data would seriously harm the interests of Patients and BRAINTALE. The User guarantees BRAINTALE in this respect and shall compensate it for any damage that BRAINTALE and/or the Solution may suffer as a result, without prejudice to the application of the provisions of the “Term, Suspension and Termination” article below.

8. RESPONSIBILITY

Access to and use of the Solution is under the sole responsibility of the User. The Solution can be used to analyze imaging and MRI data and, where applicable, provide a prediction score on the neurological condition of Patients, but cannot exempt the User from providing advice and opinions, particularly in terms of health, as a competent professional.

The User is solely responsible for discerningly and critically using the Solution and the Data, in particular the Health Data, it contains.

The User undertakes to use the Solution in accordance with its intended purpose and the conditions and specificities of use provided by BRAINTALE in the Solution’s user manual. BRAINTALE cannot be held liable for any damage caused as a result of the Solution being used outside its intended use.

The User is solely responsible for use of the Solution in compliance with the regulations applicable to his/her professional activity, in accordance with professional standards and its ethical rules. The User expressly undertakes to comply with all laws, regulations and/or directives applicable to use of the Solution.

No advice or information, whether oral or written, obtained by the User during use of the Solution is likely to create guarantees not expressly provided for in the T&Cs, or result in BRAINTALE’s liability in the event of damage of any kind whatsoever caused to the User or to third parties as a result of the User’s misuse of the Solution, in breach of the provisions of this article, and more generally for non-compliance with the T&Cs.

The User (or the Client on whose behalf he/she performs his/her duties) is liable for any damage occurring to his/her computer system, the Solution and/or its content, as well as the loss of Data that may result from use of the Solution. As such, the User (or the Client on whose behalf he/she performs his/her duties) is responsible for installing anti-virus software

and other security measures for its IT system, in order to guarantee the security of the Data in accordance with the “Guarantees” article above.

BRAINTALE has no control over the content and the Data processed on the Solution by the User, and cannot therefore be held liable in this respect.

To the fullest extent permitted by applicable law, BRAINTALE expressly excludes its liability for any indirect, incidental, special or punitive damages, resulting from or in connection with access to the Solution, its use, malfunction or unavailability, regardless of the nature and duration thereof.

The User acknowledges that BRAINTALE remains free to correct and/or modify the Solution at any time and without prior notice, without this correction and/or modification giving rise to any right of recourse on his/her part.

BRAINTALE shall not be held liable, in general, in all cases where the non-fulfillment or improper fulfillment of the T&Cs results from a case of force majeure or fortuitous event beyond its control.

9. INTELLECTUAL PROPERTY

BRAINTALE owns and retains all the intellectual property rights, including copyright and any other existing or future, French and international intellectual property rights to the Solution and the rights of the producers of existing databases in the Solution, their updates and their documentation.

The User acknowledges that the Solution is protected by intellectual property laws (such as, in particular, all copyrights, trademarks, designs, models and patents), and by the following stipulations. The Solution, as well as all the elements comprising it (in particular the texts, trees, documentation, sounds, images, photographs, illustrations, videos, written works, diagrams, logos, trademarks, designs and models, visual interfaces, user interfaces, animations, programs, software, style guide, utilities, databases, computer code, etc.) are and shall remain the exclusive property of BRAINTALE.

These T&Cs do not imply any assignment of BRAINTALE’s intellectual property rights to the User, the latter being prohibited from reserving and/or filing and/or registering any intellectual property right or title relating to any element or information that BRAINTALE makes available to him/her or that the User specifically created or invented during use of the Solution.

Similarly, the User shall refrain from communicating or marketing, directly or indirectly and in any way whatsoever, the proprietary know-how of BRAINTALE, and/or of the clients, subcontractors and partners of BRAINTALE, of which the User becomes aware in the context of using the Solution.

The granting of a license to use the Solution does not in any way confer on the User any property right and/or intellectual property right over the Solution, or its constituent elements, with the exception of a non-transferable, non-exclusive right of access limited exclusively to use of the Solution in accordance with its purpose and in accordance with these T&Cs.

The User also acknowledges that the granting of a license to use the Solution does not confer on him/her any intellectual property rights over the products, trademarks or other distinctive signs belonging to BRAINTALE, and that any use of these trademarks or distinctive signs outside the limits of strict use of the Solution in accordance with its purpose and in accordance with these T&Cs would constitute the offense of infringement.

The User undertakes never to infringe the intellectual property rights held by BRAINTALE.

Consequently, the User shall refrain from representing, reproducing and/or exploiting the Solution, in whole or in part, in any form and by any means whatsoever, without the prior written consent of BRAINTALE. The User undertakes not to copy, modify, transform, transcribe, translate, assemble, decompile, alter, sell, rent, lend, distribute and/or transfer all or part of the Solution, create derivative works from these works, authorize a third party to commit such acts or allow it to do so, without the prior written consent of BRAINTALE.

Furthermore, the User undertakes not to reproduce, imitate, modify, alter, delete and/or use the names “BRAINTALE”, “brainTale-care”, “brainQuant” and/or “brainScore-coma”, the trademarks, logos, domain names, all or part of the BRAINTALE website and/or any other content of the Solution, for any reason and in any form whatsoever, without the express written consent of BRAINTALE.

The User shall also refrain from infringing in any way whatsoever the reproduction, representation and other rights held by BRAINTALE, including pursuant to Articles L.342-1 et seq. of the French Intellectual Property Code relating to databases. The User may not, under any circumstances, reproduce or represent in its entirety the data contained in the document library. He/she shall also refrain from any qualitatively or quantitatively substantial reproduction, extraction or reuse of the content of the database, as well as the repeated and systematic extraction or reuse of qualitatively or quantitatively non-substantial parts of the content of the database.

Any use not expressly authorized by BRAINTALE hereunder is unlawful, in accordance with the French Intellectual Property Code, and therefore constitutes the offense of infringement likely to be civilly or criminally sanctioned. Any other use not provided for in the French Intellectual Property Code is subject to the prior written authorization of BRAINTALE.

The obligations stipulated herein are applicable for the entire term of the intellectual property rights of BRAINTALE and for any country, including after termination of the T&Cs.

Failure to comply with the provisions of this article constitutes an infringement of BRAINTALE’s intellectual property rights and is likely to result in civil and criminal proceedings.

10. PERSONAL DATA

Access to and use of the Solution by the User requires BRAINTALE to process the User’s Personal Data.

BRAINTALE acts as data controller within the meaning of the Data Protection Law when it processes the User’s Personal Data necessary for the creation and administrative management of the User’s User account.

The User’s Personal Data is strictly confidential and is processed by BRAINTALE for the sole purpose described above.

The User’s Personal Data will be kept for the duration of existence of the User’s account necessary to enable the User to use the Solution, and will be archived upon closure of his/her account for the legal period necessary for compliance with the legal obligations of BRAINTALE or for the purposes of proof for the establishment, exercise or defense of a legal right, then will be deleted by BRAINTALE at the end of this period.

In accordance with the Personal Data Protection Law, BRAINTALE undertakes to take all useful precautions to preserve the security and confidentiality of the User’s Personal Data. In this respect, BRAINTALE implements all technical measures to prevent the destruction, loss, alteration, disclosure or unauthorized access thereof by a third party.

In accordance with the Personal Data Protection Law, the User has a right of access, rectification, limitation, erasure and portability of the Personal Data concerning him/her. He/she also has the right to object to processing, under the conditions strictly laid down by the Data Protection Law, and the right to lodge a complaint with the French Data Protection Authority (CNIL – Commission Nationale de l’Informatique et des Libertés) or any other competent supervisory authority.

The User may exercise his/her rights or ask any questions relating to the protection of his/her Personal Data with BRAINTALE, at the following address: dpo@braintale.eu. The User is invited to indicate precisely the purpose of his/her request and the Personal Data concerned.

Furthermore, the User is expressly informed that BRAINTALE acts as a data processor, particularly with regard to Health Data, within the meaning of the Personal Data Protection Law, for the healthcare facility Client within which he/she performs his/her duties, and in this respect undertakes to comply with the obligations provided for in Article 28 of the GDPR, in accordance with the provisions of the Terms and Conditions of Subscription signed by the Client.

11. TERM, SUSPENSION AND TERMINATION

The T&Cs enter into force as soon as they are accepted by the User and for the entire duration of access and use of the Solution by the User.

In the event of use of the Solution by the User that does not comply with the T&Cs, in the event of a breach by the User of the T&Cs, or more generally in the event of a violation of the applicable laws and regulations, BRAINTALE may automatically suspend or terminate, without prior formal notice, without notice or compensation, all or part of the User’s access to the Solution. BRAINTALE may declare this suspension or termination without prejudice to all other rights, actions and remedies that BRAINTALE may have in order to compensate for the damage it may have suffered as a result of these breaches.

12. CLOUD SYSTEM

The Solution and other information contained therein is made available in web format, accessible at https://webapp.braintale.fr/brainTale-care/, according to the SaaS – Cloud information processing system.

As a result of this system, no installation is necessary to access the Solution in the form of a website. No maintenance is therefore required on User workstations, in the context of such use of the Solution. The features of the Solution are automatically updated online, without any need for Users to download anything.

13. ENTIRE AGREEMENT – INVALIDITY

The T&Cs constitute the entire agreement between the Parties relating hereto. If one or more provisions of the T&Cs are held to be invalid or declared as such pursuant to a law or regulation – and in particular European Union law – or following a final decision of a competent court, the other provisions shall retain their full force and effect. BRAINTALE will immediately make the necessary modifications, respecting, as far as possible, the spirit of the T&Cs.

14. AMENDMENT OF THE T&CS

BRAINTALE reserves the right to modify and/or update the T&Cs at any time without prior notice, of which the User will be informed. Access to and use of the Solution will be subject to the T&Cs in force at the time of such access and use.

15. WAIVER

The fact that BRAINTALE or the User does not avail itself of one or more provisions of the T&Cs may not under any circumstances imply the waiver by either of them of their right to invoke it at a later date.

16. GOVERNING LAW AND JURISDICTION

The T&Cs shall be performed and interpreted in accordance with French law, to the exclusion of its conflict of laws rules. Any litigation and disputes relating to the T&Cs, their interpretation, validity and/or performance, not resolved amicably at the end of a period of sixty (60) days from the first notification of the dispute by way of a letter sent by registered post with acknowledgment of receipt, may be brought by the first Party to take action before the exclusive jurisdiction of the competent courts of Paris, France or its presiding judge with regard to summary proceedings, notwithstanding the plurality of defendants or the introduction of third parties.

As part of our service, we may process your personal data. For more information, see our privacy policy available here. https://www.braintale.eu/data-privacy-policy/.