Terms of Sale of WeDiagnostix Solution & Application

Version software : 1.0.1Version ToS : 02

Terms of Sale (ToS)

 WeDiagnostix Solution  – Application 

Article 1.  Preamble 

  1. These General Terms and Conditions of Sale (hereinafter the “ToS”) are intended to define the conditions under which WeDiagnostiX (hereinafter “WeDiagnostiX” or the “Company”) markets the WeDiagnostix solution (hereinafter the “Solution”) to the end user (hereinafter the “User”).
WeDiagnostiX is a société par actions simplifiée with a share capital of EUR 393,230, whose registered office is located at 7 allée des Genêts, 92420 Vaucresson, France, registered with the Nanterre Trade and Companies Register under number 884 167 925 – Tel.: 0651700895 – email address: support@wediagnostix.ai  intra-Community VAT number: FR84 884 167 925.
  1. These ToS govern the marketing of the Solution, the subscription, payment, and post-invoicing access to the Solution by the User. They are supplemented, where applicable, by the Terms and Conditions (hereinafter the “TaC”), which specify the technical conditions for access to and operation of the Solution.
  2. The Solution constitutes a CE-marked Class IIa software medical device, in accordance with Regulation (EU) 2017/745 on medical devices.
  3. It is recalled that the TaC defines the rules governing the use of the Solution as a software medical device. These ToS govern exclusively the contractual relationship between WeDiagnostiX and the User making use of the Solution.
  4. Any order, subscription, or contractual engagement with WeDiagnostiX implies full and unconditional acceptance, without restriction or reservation, of these ToS, which the User acknowledges having read and accepted as an integral part of the subscription.
These ToS shall apply to the exclusion of all other provisions (including any general terms and conditions of the User). Accordingly, any marketing of the Solution by the Company necessarily implies, as an essential condition, the User’s unconditional acceptance of these ToS, notwithstanding any contrary provision, subject always to any specific terms that may be expressly agreed between the Company and the User and formalized in writing.In the event of any conflict between the specific terms and these ToS, the specific terms shall prevail. In the event of any conflict between the TaC and these ToS, these ToS shall prevail.

Article 2. Definitions 

  1. The terms defined below, whether used in the singular or plural and with or without capitalization, shall have the following meanings:
  • “ToS”: these General Terms and Conditions of Sale, applicable solely to the relationship between WeDiagnostiX and the User;
  • “TaC”: the Company’s Terms and Conditions, applicable solely to the relationship between WeDiagnostiX and the User;
  • “Offer”: shall have the meaning given to it in Article 5.1 (Offer);
  • “Solution”: the CE-marked Class IIa software medical device using a cloud-based service that provides analysis of dental panoramic radiographs through artificial intelligence and deep learning algorithms developed by WeDiagnostiX;
  • “Company” or “WeDiagnostiX”: means the société par actions simplifiée with a share capital of EUR 393,230, whose registered office is located at 7 allée des Genêts, 92420 Vaucresson, France, and which is registered with the Nanterre Trade and Companies Register under number 884167925;
  • “Service”: the services provided by WeDiagnostiX through the Solution to end users;
  • “User”: any natural person who is a healthcare professional, dental surgeon, or physician with competence in dental radiology and who accesses the Services for the full Service and/or any healthcare professional authorized, in the course of their professional practice, to access the Services;
  • “Parties”: means the Company and the User.
 

Article 3.  Purpose

  1. These ToS are intended to define the conditions under which WeDiagnostiX markets the Solution to Users, the Solution being a CE-marked Class IIa software medical device in accordance with Regulation (EU) 2017/745.
  2. For the purposes of this document:

3.1. Paid access to the Solution

  1. WeDiagnostiX grants the User a personal, limited, non-exclusive, and non-transferable right to access and use the Solution in accordance with its intended purpose and these ToS.
9.This right of use is strictly limited to the User’s personal and professional use, to the exclusion of any unauthorized commercial exploitation, reproduction, distribution, or making available to third parties.Access to the Solution is strictly limited to the number of accounts / Users authorized under the Offer. Any use outside this scope (sharing of access, collective access, use on behalf of unauthorized third parties, etc.) may result in additional billing, suspension, and/or termination.The following are in particular prohibited, without this list being exhaustive: any extraction or reuse, in whole or in part, of the Solution; any automated collection of data (scraping); any operation intended to assess, analyze, or measure the performance, capacity, stability, or results of the Solution, in particular for comparison purposes; any use for competitive purposes; any circumvention of technical protection measures; as well as any publication or dissemination of comparative results without the prior written consent of WeDiagnostiX.

3.2. Financial terms

  1. Use of the Solution is subject to the User subscribing to a paid subscription, in accordance with the pricing conditions, billing frequency, and invoicing terms specified at the time of the order (via Stripe).
The amount of the subscription is indicated exclusive of taxes (excl. VAT) at the time of subscription.In the event of non-payment of the sums due, WeDiagnostiX reserves the right to suspend access to the Solution until regularization, under the conditions set out in Article 7.4 (Payment Incident) below.
  1. These ToS apply solely to the contractual relationship between WeDiagnostiX and the User. The conditions governing the use of the Solution by Users are set out in the TaC made available to Users of the Solution.
 

Article 4. Description of the Services 

The Services made available to the User enable the generation of radiological reports for their patients, supported by an artificial intelligence system.

Article 5. Offer and pricing

5.1. Offer

  1. The essential characteristics of the Solution, as well as the different subscription plans offered (monthly or annual), are presented to the User prior to any subscription (the “Offer”). WeDiagnostiX reserves the right to modify the content of the Offer at any time, without prejudice to subscriptions already in progress.
Any services falling outside the scope of the subscription shall be subject to additional invoicing based on a quotation.

5.2. Prices

  1. The applicable prices are those in force on the date of the User’s subscription. They are expressed in euros exclusive of taxes (excl. VAT). Any applicable taxes, duties, charges, or contributions, in particular value added tax (VAT), shall be invoiced in addition at the rate in force on the date of invoicing and shall remain the sole responsibility of the User.

5.3. Price revisions

  1. WeDiagnostiX reserves the right to modify its prices at any time. Any price change shall be notified to the User at least thirty (30) calendar days before it takes effect.
In the event of disagreement, the User may terminate their subscription before the new price takes effect, in accordance with the terms set out in Article 8 (Term and Termination). 

5.4. Promotions and special offers

  1. WeDiagnostiX may offer occasional promotional offers. Such offers are limited in time and may under no circumstances be considered as permanently acquired by the User for subsequent periods.

Article 6. orders and subscription

  1. The process for ordering and subscribing to the Solution by the User is governed by the following provisions:

6.1. Subscription process

To access the Solution, the User must create a personal account by providing the requested information.Subscription to the Solution is completed online, via the WeDiagnostiX website, which redirects to a partner payment platform (Stripe).

6.2. Order confirmation

Before confirming their order, the User is invited to review the details of their subscription and its total price, and to accept these ToS. The subscription shall become firm and final once payment has been confirmed by the selected payment service provider (Stripe).

6.3. Subscription confirmation

Once the order has been validated and payment confirmed, the User shall receive an email confirmation summarizing the essential characteristics of the subscription, its price, the selected duration, as well as a link to these ToS.

6.4. Availability of the Solution

Access to the Solution shall become effective upon validation of the order and activation of the User’s account, unless otherwise specified at the time of subscription.By subscribing, the User acknowledges that this software is a Class IIa medical device in accordance with Regulation (EU) 2017/745. It is intended to provide information used for diagnostic or therapeutic purposes only within the European Union and in other jurisdictions recognizing the CE marking. The User further acknowledges that this software has not been authorized for clinical use in jurisdictions that do not recognize the CE marking, including, but not limited to, the United States (FDA), Canada (Health Canada), the United Kingdom (MHRA), Brazil (ANVISA), and Switzerland (Swissmedic). Clinical use of the software may be subject to additional regulatory requirements, including local language requirements, in certain jurisdictions, including Denmark, Finland, Hungary, Latvia, Lithuania, Romania, Sweden, and Norway. The User is responsible for ensuring that use of this software complies with all applicable local regulations.

Article 7. Payment terms

  1. The payment terms for the Solution by the User are governed by the following provisions:

7.1. Means of payment

Payment for the subscription shall be made online at the time of subscription, through WeDiagnostiX’s secure partner payment service providers (Stripe) by bank card, Apple Pay, Link, Bancontact, BLIK, EPS, and Klarna.

7.2. Payment security

All transactions are processed via a secure connection in accordance with applicable standards (PCI-DSS for card payments). WeDiagnostiX does not at any time store the User’s bank card details.

7.3. Billing frequency

Payment is due at the beginning of each subscription period (monthly, annually, or otherwise, depending on the selected plan). The subscription shall be automatically renewed upon expiry, unless terminated by the User in accordance with the conditions set out in Article 8 (Term and Termination).

7.4. Payment incident

In the event of a failed direct debit or non-payment when due, WeDiagnostiX may immediately suspend access to the Solution until full payment of all amounts due.If the situation continues for more than fifteen (15) calendar days from the failed direct debit or non-payment when due, WeDiagnostiX may automatically terminate the subscription by registered letter with acknowledgement of receipt, without prejudice to any recovery action and without court formality or compensation to the User.Without prejudice to any other remedies available, any late payment shall automatically result in:
  • the immediate suspension of the User’s access to the Solution;
  • the immediate payment of all sums remaining due under the current subscription between the Company and the User, regardless of the method of payment or the originally agreed due date;
  • payment of a fixed indemnity of forty (40) euros corresponding to recovery costs due for each invoice not paid on time (in accordance with Article D.441-5 of the French Commercial Code);
  • the automatic application of late payment penalties at a rate equal to the refinancing rate of the European Central Bank plus ten (10) percentage points, in accordance with Article L.441-6 of the French Commercial Code, taking effect from the day following the payment date stated on the invoice;
  • the application, by way of damages, of an indemnity equal to ten percent (10%) of the unpaid amount, together with all legal and collection costs.

Article 8. Term and termination

  1. The term and termination of the User’s subscription to the Solution are governed by the following provisions:

8.1. Initial term

The subscription to the Solution is entered into for an initial term corresponding to the plan chosen by the User (monthly or annual), starting from the date of validation of the order.

8.2. Automatic renewal

At the end of the initial term, the subscription shall be automatically renewed for successive periods of the same duration, unless terminated by the User under the conditions described below.WeDiagnostiX reserves the right to amend these ToS. Any substantial amendment shall be notified to the User. The new ToS shall enter into force upon acceptance by the User. Failing such acceptance, the ToS previously accepted by the User shall remain applicable.

8.3. Résiliation par l’Utilisateur

The User may terminate their subscription at any time from their personal account area, in accordance with the conditions applicable to the relevant subscription channel, or by registered letter with acknowledgment of receipt.The User may check the status of their subscription in the “Profile” section, under “Subscriptions,” from the Solution interface (Settings icon > Users tab). When an active subscription is associated with the User’s account, a “Manage subscriptions” button is displayed. By clicking this button, the User is redirected to the secure subscription management interface provided by the dedicated payment platform.Subscription management, including termination, modification, or any other operation relating thereto, is carried out directly through this interface. Termination shall take effect in accordance with the applicable conditions and on the end date of the current subscription period.Any subscription period that has commenced shall be due in full. Termination shall take effect at the end of the current subscription period. No pro rata refund shall be made, including in the event of early termination by the User. 

8.4. Termination by WeDiagnostiX

WeDiagnostiX reserves the right to terminate the User’s subscription as of right by registered letter with acknowledgment of receipt, without prior notice, in the event of a serious or repeated breach of these ToS or the TaC (in particular fraudulent use, non-compliance with the medical intended purpose, or non-payment).Termination as of right, as defined above, shall not exclude any measure intended to preserve the rights of the aggrieved party – in addition to any compensation to which it may validly be entitled further to the termination of the contractual relationship – nor any other action, whatever its nature or purpose.

Article 9. Right of withdrawal

  1. The right of withdrawal shall not apply to Users acting in the course of their professional activity. Any subscription entered into by a professional customer shall be firm and final.
  2. By validating their order and immediately accessing the Solution, the User acknowledges that they have:
  • requested the immediate performance of the contract,
  • been informed of the loss of their right of withdrawal,
  • expressly waived their right of withdrawal.

Article 10. Liability

Article 10.1. Obligations of WeDiagnostiX

  1. WeDiagnostiX, in its capacity as manufacturer of the Solution within the meaning of Regulation (EU) 2017/745 on medical devices, undertakes to:

10.1.1. Regulatory compliance 

  • make available a Solution that complies with the applicable essential requirements of Regulation (EU) 2017/745;
  • maintain the CE marking of the Solution at all times, provided that the conditions of use contractually defined are complied with by the User.

10.1.2. Maintenance and updates

  • provide corrective maintenance for the Solution in order to remedy any identified malfunction;
  • deploy the updates necessary for the security, performance, and regulatory evolution of the Solution;
  • inform the User of any major update likely to affect the technical or functional integration of the Solution..

10.1.3. Technical support

  • provide the User with level 1 technical support for incidents directly related to the Solution;
  • make available a user manual enabling the User to use the Solution in accordance with its intended purpose..

10.1.4. Vigilance and safety

  • implement a post-market surveillance and vigilance system, and inform the User of any event or safety measure likely to impact the Solution.

10.1.5 Exclusions 

The User shall remain solely responsible for the medical and clinical decisions taken in the course of their professional activity.The Solution constitutes a tool providing information that may be used for diagnostic purposes and shall neither be used in isolation nor substitute for the User’s clinical judgment.Accordingly, WeDiagnostiX shall not be held liable, in particular, for:
  • clinical or medical decisions taken by the User on the basis of the results provided by the Solution, the latter not constituting a standalone diagnostic device;
  • service unavailability, malfunction, or degradation attributable to telecommunications networks, operators, browsers, equipment, or infrastructures used by the User;
  • any use of the Solution that is not in accordance with the instructions for use, the documentation provided, these ToS, the TaC, and, where applicable, any specific terms;
  • the User’s failure to comply with updates, patches, or security measures duly notified by WeDiagnostiX;
  • any unauthorized modification, adaptation, or intervention relating to the Solution;
  • any failure by the User to comply with vigilance, control, or verification obligations incumbent upon them;
  • any content, data, or information imported, entered, or used by the User, in particular as regards their accuracy, lawfulness, and compliance with third-party rights;
  • the User’s failure to comply with their legal, regulatory, professional, or ethical obligations.

10.1.6 Indirect loss

Under no circumstances shall WeDiagnostiX be held liable for any indirect loss or damage, including, without limitation, loss of business, loss of turnover, loss of profits, loss of data (except in the case of proven fault directly attributable to WeDiagnostiX), loss of opportunity, or damage to image or reputation.In any event, WeDiagnostiX may only be held liable where there is proven fault directly attributable to WeDiagnostiX, a certain and direct loss, and a causal link between such fault and the alleged loss.

10.1.7 Liability cap

The aggregate liability of WeDiagnostiX, for all losses combined, shall be capped at the total amount actually paid by the User under the Subscription during the twelve (12) months preceding the event giving rise to the claim (or three (3) months if the subscription has been in force for less than twelve (12) months).

Article 10.2.  Obligations of the User

  1. The User undertakes to:

10.2.1. Compliance with contractual use

  • use the Solution in accordance with its intended purpose, the instructions for use, the documentation provided, these ToS and the TaC, and, where applicable, any specific terms;
  • provide accurate information upon registration and keep such information up to date;
  • preserve the confidentiality of their credentials and not share them with third parties;
  • acknowledge that the Solution constitutes a tool providing information that may be used for diagnostic purposes and undertake never to use it in isolation or as a substitute for their clinical judgment, remaining solely responsible for all medical and clinical decisions made;
  • guarantee the accuracy, relevance, lawfulness, and regulatory compliance of the data, content, or information imported, entered, or processed by the User through the Solution, in particular with regard to medical confidentiality, the provisions of French Act No. 78-17 of 6 January 1978 as amended relating to the protection of individuals with regard to the processing of personal data, and the rights of patients and third parties

10.2.2. Confidentiality and security

The User undertakes to:
  • not misuse or attempt to misuse the Solution for purposes other than its intended use;
  • install without delay all updates, patches, and security measures notified by the Company, and implement all vigilance measures necessary to ensure the security of systems, equipment, and access;
  • refrain from any modification, adaptation, decompilation, reverse engineering, or unauthorized intervention on the Solution, as well as from any circumvention of technical protection measures;
  • report to WeDiagnostiX any malfunction, incident, or complaint relating to the Solution;
  • refrain from any use of the Solution for competitive purposes, unauthorized comparative evaluation, performance analysis, or automated data collection, whether directly or indirectly;
  • comply with all applicable laws, professional obligations, ethical obligations, and regulations, in particular in the fields of healthcare and personal data, and hold the Company harmless from any consequences arising from a breach of such obligations;
  • ensure the confidentiality and security of their access credentials to the Solution and remain solely responsible for any use carried out through their account;
  • promptly inform the Company of any malfunction, security incident, anomaly, or non-compliant use of which they become aware, and cooperate in good faith in any reasonable corrective action.
 

Article 11. Intellectual property

11.1. Ownership of rights

  1. WeDiagnostiX shall remain the sole owner of all intellectual property rights relating to the Solution, including, without limitation, its source and object code, software architecture, interfaces, design, logos, trademarks, as well as any associated documentation and content. 
  2. The Solution, trademarks, drawings, models, images, texts, photographs, logos, graphic charters, software and programs, databases, sounds, videos, domain names, design, or any other element composing the Solution, with the exception of third-party elements defined below and the health data of patients whose panoramic radiographs are analyzed by the Solution, are the exclusive property of WeDiagnostiX and are protected by any intellectual or industrial property rights recognized under the laws in force.
  3. Any reproduction and/or representation, in whole or in part, of any of these rights without the express authorization of WeDiagnostiX is prohibited and would constitute infringement likely to give rise to the civil and criminal liability of the infringer.
 
  1. Consequently, the User shall refrain from any conduct or act likely to infringe directly or indirectly the intellectual property rights of WeDiagnostiX.

11.2. Absence de transfert de droits

  1. The conclusion of these ToS shall not entail any transfer of intellectual property rights in favour of the User.
In particular, the User shall acquire no right of reproduction, distribution, modification, translation, adaptation, decompilation, or any other right in relation to the Solution, except for the licence of use provided below.

11.3. Licence of use granted

  1. WeDiagnostiX grants the User, for the duration of their subscription, a personal, non-exclusive, non-assignable, and non-transferable right to access and use the Solution, in accordance with its medical intended purpose and these ToS/TaC.
Unless expressly authorized in writing in advance by WeDiagnostiX, the User is strictly prohibited from:
  • reproducing, copying, modifying, adapting, altering, or translating all or part of the Solution;
  • carrying out any reverse engineering, decompilation, disassembly, or attempt to reconstruct the source code;
  • assigning, renting, lending, distributing, or making the Solution available to third parties;
  • using the Solution for purposes other than those provided for by its medical intended purpose and instructions for use.

11.4. Restrictions

  1. Any use of the Solution outside the scope defined above is strictly prohibited and may result in the immediate suspension of access to the Solution, unless otherwise agreed in writing in advance by WeDiagnostiX. 
The User undertakes to respect the intellectual property rights of WeDiagnostiX.

11.5. Third-party elements

  1. Elements belonging to third parties, such as film excerpts, trademarks, logos, images, texts, and sounds, this list not being exhaustive, are the exclusive property of their author and are protected as such by copyright, trademark law, or any other rights recognized under the laws in force.
 
  1. The User shall refrain from infringing, directly or indirectly, the proprietary rights of third parties whose content is present on the Solution and shall refrain from exploiting such elements in any manner whatsoever.
 
  1. The User undertakes to respect all rights of third parties whose content is present on the Solution.
 

Article 12. Force majeure

  1. Neither Party shall be held liable for any delay in performance or failure to perform any of its contractual obligations resulting from a force majeure event within the meaning of Article 1218 of the French Civil Code and French case law.
  2. The following shall in particular be considered force majeure events (without this list being exhaustive): natural disasters, fires, floods, widespread power outages, failures of telecommunications or hosting networks, cyberattacks of exceptional magnitude, general strikes, pandemics, and governmental or legal decisions rendering performance of the contract impossible.
  3. In the event of such an occurrence, the affected Party shall inform the other Party as soon as possible. Performance of the obligations shall be suspended for the duration of the force majeure event, without any entitlement to compensation. If the duration of the impediment exceeds sixty (60) consecutive calendar days, either Party may terminate the contract automatically and as of right, without compensation to either Party.
 

Article 13. Electronic communication and evidence

  1. Neither Party shall be held liable for any delay in performance or failure to perform any of its contractual obligations resulting from a force majeure event within the meaning of Article 1218 of the French Civil Code and French case law.
  2. The following shall in particular be considered force majeure events (without this list being exhaustive): natural disasters, fires, floods, widespread power outages, failures of telecommunications or hosting networks, cyberattacks of exceptional magnitude, general strikes, pandemics, and governmental or legal decisions rendering performance of the contract impossible.
  3. In the event of such an occurrence, the affected Party shall inform the other Party as soon as possible. Performance of the obligations shall be suspended for the duration of the force majeure event, without any entitlement to compensation. If the duration of the impediment exceeds sixty (60) consecutive calendar days, either Party may terminate the contract automatically and as of right, without compensation to either Party.
 

Article 14. Applicable law, competent jurisdiction, and disputes

  1. All clauses set out in these ToS, as well as all purchase and sale transactions referred to herein, shall be governed by French law.
  2. In the event of any dispute relating to the validity, interpretation, performance, or termination of these terms, the Parties shall endeavour to find an amicable solution.
  3. Failing an amicable agreement within thirty (30) calendar days, the dispute shall be submitted to the exclusive jurisdiction of the French courts.
 

Article 15. Final provisions

15.1. Partial invalidity

  1. If any provision of these ToS is declared null and void, deemed unwritten, or unenforceable, the remaining provisions shall remain in full force and effect.

15.2. Amendment of the ToS

  1. WeDiagnostiX reserves the right to amend these ToS at any time. The applicable ToS shall be those in force on the date of validation of the order. Any amendment shall be communicated to the User via the website or by email.

15.3 Confidentiality

  1. The Parties shall be bound by an obligation of confidentiality.
  2. The Parties undertake not to disclose to any third party, directly or indirectly, any document, knowledge, know-how, information, or data relating to either of them or to their operating methods, which they may have become aware of or had access to, unless such confidential information has entered the public domain or its disclosure is required pursuant to a specific regulation or an administrative or judicial order.
  3. The Parties shall remain bound by this obligation for the entire duration of the subscription and for a period of ten (10) years after its expiry.
 

These Terms of Sale shall be effective as of 20/03/2026.