General Terms and Condition of Use

GENERAL TERMS AND CONDITIONS OF USE

E-SCOPICS ULTRASOUND IMAGING SOLUTION

E-SCOPICS is a simplified joint stock company with a share capital of €100,000, whose registered office is located at 931 Chemin de la Bosque d’Antonnelle 13090 – AIX-EN-PROVENCE, registered in the Trade and Companies Register under number 841 467 293 RCS Aix-en-Provence, and represented by Mr. Claude COHEN-BACRIE in his capacity as CEO, duly authorised for the purposes hereof (hereinafter “E-SCOPICS”).

E-SCOPICS is a company specialised in the sector of research and development in other physical and natural sciences which develops and manufactures medical devices. As part of its activities, E-SCOPICS has developed a dematerialised ultrasound device based on the use of an ultra-portable probe, a connected low power digital transducer and a software application (hereafter the “Solution“).

These general terms and conditions of use (hereinafter the “GTC“) constitute binding contractual provisions which aim to define the conditions under which Users (as defined hereinafter) are authorised to access and use the Solution, and more broadly their rights and obligations within the framework of this use.

The Solution is the exclusive property of E-SCOPICS. All rights are reserved.

USERS ARE ADVISED TO READ THE GTC VERY CAREFULLY BEFORE USING THE SOLUTION. ANY USER USING THE SOLUTION IS DEEMED TO HAVE READ THE GTC AND TO ACCEPT THEM WITHOUT RESTRICTION OR RESERVATION.

DEFINITIONS

In the GTC, the words and expressions identified below by a capital letter have the corresponding meaning, whether they are used in the singular or plural. Any capitalized but otherwise undefined terms shall have the meaning ascribed to such terms in the Software as a Service Terms of Service Agreement between the User and E-SCOPICS.

Client: means the natural or legal person who has acquired a user licence from E-SCOPICS allowing Users to access and use the Solution. When the Client is a natural person, in particular a self-employed health professional using the Solution as part of his professional activities, he acts as a User in the context of the execution of these GTC. The Client as a legal entity is strictly understood as an establishment, in the legal sense of the term (individually identified by a registration number – main establishment, secondary establishment, subsidiary, branch, site, etc.).
Data: refers collectively to Health Data and Personal Data.
Data Protection Law: refers collectively to the French law n°78-17 of 6 January 1978 on Data Processing, Files and Liberties as amended (known as the “Loi Informatique et Libertés” i.e. the “French data protection Act“) and the Regulation (EU) n°2016/679 on the protection of individuals 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“).
Documentation: means the documentation of any kind relating to the Solution, including the Hardware, drawn up by E-SCOPICS, and which constitutes the referential of the technical and functional specifications of the Solution marketed by E-SCOPICS.
GTC: refers to these general terms and conditions of use of the Solution.
Hardware: means the ultrasound probe allowing the collection of Data from Patients by ultrasound and which is necessary for the running of the Solution.
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 health status. In the context of the use of the Solution, Health Data includes ultrasound imaging data generated by the software during ultrasound scans of Patients.
Parties: means individually E-SCOPICS or the User, and collectively E-SCOPICS and the User.
Patient: means any patient receiving health care services provided by the User and on whom an ultrasound exam is performed using the Solution.
Personal Account: refers to the User’s personal account enabling him/her to access and use the Solution.
Personal Data: means within the meaning of the GDPR any information relating to an identified or identifiable natural person; an “identifiable natural person” is one 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 his or her physical, physiological, genetic, mental, economic, cultural or social identity.
Solution: means the ultraportable ultrasound device using a combination of the Hardware and a software solution which was developed and marketed by E-SCOPICS. The Solution is further described in section 3 of the GTC.
Usable Anonymous Data: refers to the data resulting from the process of complete anonymisation of Personal Data, so that the latter are devoid of any directly or indirectly identifying character and, consequently, are no longer subject to the Data Protection Law.
User: means any natural person entitled to access and use the Solution in strict compliance with the terms of these GTC.

ACCEPTANCE AND EFFECTIVENESS OF THE GTC

The GTC constitutes an agreement between the User and E-SCOPICS. Access to the Solution is subject to the User’s express and unreserved acceptance of the provisions of the GTC. Failure to accept the GTC will make it impossible for the User to access and use the Solution.

The User’s acceptance of the GTC is required at his first connection to the Solution. The User must read the GTC and then, if he accepts them, click on the “I accept the General Terms and Conditions of Use” box. By doing so, the User acknowledges having read the GTC, having understood them, and fully accepting all their provisions, without restriction or reservation.

E-SCOPICS retains the right to modify and/or update the GTC at any time. In the event of an update of the GTC, E-SCOPICS will inform the User by any written means, including by e-mail and/or directly via the Solution, specifying their date of entry into force, so that the User can review the amended GTC and accept them. If the User continues to use the Solution after the date of entry into force of the modified GTC, he/she shall be deemed to have accepted them unreservedly.

DESCRIPTION OF THE ULTRASOUND IMAGING SOLUTION

The Solution is an ultraportable ultrasound device based on the use of software technology to produce ultrasound images using the algorithm developed by E-SCOPICS.

The Solution, qualified as a medical device within the meaning of Regulation (EU) 2017/745 of 5 April 2017 on medical devices, thus enables ultrasound examinations of Patients.

The Solution thus allows the output of ultrasound imaging Data associated with biomarkers, through the use of an ultraportable ultrasound probe enabling the input of raw data.

As a medical device, the Solution has been designed and developed in accordance with the applicable requirements of Regulation (EU) 2017/745 on medical devices, and as such has been certified and has the CE conformity marking.

No other purpose or guarantee is given by E-SCOPICS, which the User acknowledges and accepts.

CONDITIONS OF ACCESS TO THE SOLUTION

Creation and access to the Personal Account

Access to and use of the Solution are subject to these GTC and more generally to compliance with all applicable laws and regulations.

In order to access and use the Solution, the User must create a Personal Account. To do so, the User must have the necessary equipment in accordance with the provisions of section 4.2 of the GTC, as well as a valid email address.

All costs relating to the access, installation and/or use of the Solution (telecommunication costs in particular, etc.) shall be borne exclusively by the User. The User is solely responsible for the proper functioning of his computer equipment and his access to the Internet.

The User acknowledges and accepts that the use of the Solution is reserved for persons of legal age and capacity.

The User must follow the procedure for requesting the creation of a Personal Account which is available directly on the Solution and to fill in the information requested in the form intended for this purpose (identification data, email address and password), and then to tick the box accepting the GTC.

When registering, the User must provide complete and accurate information. The User must regularly review the accuracy of this information and update it whenever necessary.

The Personal Account enabling the User to access the Solution is accessible through the User’s personal identifier and password, which are required at each connection to the User’s Personal Account.

The User’s login and password are strictly personal and confidential and must not be disclosed or shared with third parties under any circumstances. The User is personally responsible for keeping them confidential, as well as for any actions, fraudulent or not, that would be carried out from his Personal Account.

All Users expressly undertake never to use the Personal Account of another User. The User undertakes to inform E-SCOPICS, without delay, of any suspicion or unauthorized use of his account, by email to the following address support@e-scopics.com. In any case, E-SCOPICS cannot be held liable for the loss, theft or forgetfulness of the User’s login details to his Personal Account or for their fraudulent use of the latter.

Minimum system requirements and hardware needed to access the Solution

The User is informed that the Solution is available in “on premise” format, which implies that it must first be downloaded and installed by the User.

In this context, the User acknowledges and accepts that the use of the Solution requires adequate computer equipment (PC) and a broadband internet connection enabling the Solution to be downloaded. All costs incurred by the User in accessing and using the Solution, such as, but not limited to, hardware costs, software costs and internet access provider costs, shall be borne exclusively by the User.

The User is solely responsible for the protection of his computer equipment against intrusions, for security updates of the operating systems and for the necessary anti-virus installations. E-SCOPICS shall not be held liable under any circumstances for the presence of computer viruses that have infected the User’s computer equipment and, more generally, for any problem affecting all the equipment and Internet lines used by the User to access the Solution.

User Systems. The User is responsible for (a) obtaining, deploying and maintaining the customer system, and all computer hardware, software, modems, routers and other communications equipment necessary for Customer, its Affiliates and their respective Users to access and use the Services via the Internet; (b) contracting with third party ISP, telecommunications and other service providers to access and use the Supplier Services via the Internet; and (c) paying all third party fees and access charges incurred in connection with the foregoing. Except as specifically set forth in these Terms, an Order Form or a Statement of Work, Supplier shall not be responsible for supplying any hardware, software or other equipment to Customer under these Terms.

Accuracy of User’s Contact Information; Email Notices. User agrees to provide accurate, current and complete information as necessary for E-SCOPICS to communicate with User from time to time regarding the Services, issue invoices or accept payment, or contact User for other account-related purposes. User agrees to keep any online account information current and inform E-SCOPICS of any changes in User’s legal business name, address, email address and phone number. User agrees to accept emails from E-SCOPICS at the e-mail addresses specified by its Admin Users for login purposes. In addition, User agrees that E-SCOPICS may rely and act on all information and instructions provided to E-SCOPICS by Users from the above-specified e-mail address.

AVAILABILITY AND OPERATION OF THE SOLUTION

The Solution is in principle accessible 24 hours a day, 7 days a week, subject to the occurrence of an event of force majeure or an event beyond the control of E-SCOPICS and except for interruption, suspension or limitation in the context of maintenance operations and/or updates which are necessary for the proper functioning of the Solution.

E-SCOPICS is only bound by an obligation of means concerning the accessibility, operation and availability of the Solution or its functions. The User acknowledges and accepts the possibility that the functioning of the Solution may be interrupted or limited, in particular due to legal or technical constraints, in the event that he does not update the software as recommended by E-SCOPICS.

Furthermore, the User acknowledges and accepts that the Solution exists solely within the limits of the technical possibilities.

Consequently, within the constraints of the applicable regulations, each User acknowledges that :

E-SCOPICS does not guarantee that the Solution will function without interruption or error if the User does not have the required level of configuration on his IT tools;
E-SCOPICS does not exercise any control or supervision over the Data, content and information generated, produced, exchanged, and/or uploaded through the Solution and cannot be held responsible in any way whatsoever in this respect;
E-SCOPICS has no control over the use of the Solution by the Users; consequently, E-SCOPICS cannot be held liable in any way for the modification or deletion of Data or any other result obtained through the use of the Solution.

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 needs of his professional activity and undertakes to use the Solution for the needs of this activity exclusively.

The User therefore acknowledges and accepts that the Solution is a medical device, and therefore expressly undertakes to use it in strict compliance with the Documentation provided by E-SCOPICS, in order to ensure the proper functioning of the Solution.

The User undertakes also to use the Solution in accordance with the GTC, in compliance with his professional and/or ethical obligations and, more generally, with any international, European and national laws and regulations that are applicable.

The User who is required to process Data in the context of the use of the Solution undertakes to comply with the legal and regulatory requirements on the protection of Personal Data.

Acceptable Use Policy. Subject to the terms of E-SCOPICS’ Privacy Policy, User shall be solely responsible for its actions and the actions of its Users while using the Supplier Service. User acknowledges and agrees: (a) to abide by all local, state, national, and international laws and regulations applicable to Customer’s use of the Service, including without limitation the provision and storage of Customer Data; (b) not to send or store data on or to the Service which violates the rights of any individual or entity established in any jurisdiction; (c) not to upload in any way any information or content that contain Malicious Code or data that may damage the operation of the Services or another’s computer or mobile device; (d) not to upload in any way any data regarding an individual’s financial or economic identity, sexual orientation, religious beliefs, medical or physical identity, including any information comprised of either “Protected Health Information” subject to and defined by the Health Insurance Portability and Accountability Act, or an individual’s first name and last name, or first initial and last name, in combination with any one or more of the following data elements that relate to such individual: Social Security number, driver’s license number or state-issued identification card number, financial account number, or credit or debit card number, with or without any required security code, access code, personal identification number or password, that would permit access to an individual’s financial account; (e) not to use the Service for illegal, fraudulent, unethical or inappropriate purposes; (f) not to interfere or disrupt networks connected to the Service or interfere with other ability to access or use the Service; (g) not to distribute, promote or transmit through the Service any unlawful, harmful, obscene, pornographic or otherwise objectionable material of any kind or nature; (h) not to transmit or post any material that encourages conduct that could constitute a criminal offense or give rise to civil liability; (i) not to interfere with another customer’s use and enjoyment of the Service or another person or entity’s use and enjoyment of similar services; (j) not to use the Service in any manner that impairs the Supplier Service, including without limitation the servers and networks on which the Supplier Service is provided; (k) to comply with all regulations, policies and procedures of networks connected to the Service and service providers; and (l) to use the Services only in accordance with the Documentation. User acknowledges and agrees that E-SCOPICS neither endorses the contents of any User communications, User Data, or Other Information nor assumes any responsibility for any offensive material contained therein, any infringement of third party Intellectual Property Rights arising therefrom or any crime facilitated thereby. E-SCOPICS may remove any violating content posted or stored using the Service or transmitted through the Service, without notice to User. Notwithstanding the foregoing, E-SCOPICS does not guarantee, and does not and is not obligated to verify, authenticate, monitor or edit the Customer Data, Other Information, or any other information or data input into or stored in the Service for completeness, integrity, quality, accuracy or otherwise. User shall be responsible and liable for the completeness, integrity, quality and accuracy of User Data and Other Information input into the Supplier Services. E-SCOPICS reserves the right to amend, alter, or modify User’s conduct requirements as set forth in these Terms at any time. E-SCOPICS may deliver notice of such updated requirements to User via e-mail or through the Supplier Services. User’s continued access to and use of the Supplier Services following issuance of such updated User requirements shall constitute Customer’s acceptance thereof. Supplier may upon written notice to User amend these provisions.

Temporary Suspension. E-SCOPICS may temporarily suspend User’s, its Affiliates’ or their respective Users’ access to the Services in the event that either User, its Affiliates or any of their Users is engaged in, or E-SCOPICS in good faith suspects User, its Affiliates’ or any of their Users is engaged in, any unauthorized conduct (including, but not limited to any violation of these Terms). E-SCOPICS will attempt to contact User prior to or contemporaneously with such suspension; provided, however, that E-SCOPICS’ exercise of the suspension rights herein shall not be conditioned upon User’s receipt of any notification. A suspension may take effect for User’s entire account and User understands that such suspension would therefore include its Affiliates and User sub-accounts. User agrees that E-SCOPICS shall not be liable to User, any of its Affiliates or Users, or any other third party if E-SCOPICS exercises its suspension rights as permitted by this Section. Upon determining that User has ceased the unauthorized conduct leading to the temporary suspension to E-SCOPICS’ reasonable satisfaction, E-SCOPICS shall reinstate User’s, its Affiliates and their respective Users’ access and use of the E-SCOPICS Services. Notwithstanding anything in this Section to the contrary, E-SCOPICS’ suspension of Services is in addition to any other remedies that E-SCOPICS may have under these Terms or otherwise, including but not limited to termination of these Terms for cause. Additionally, if there are repeated incidences of suspension, regardless of the same or different cause and even if the cause or conduct is ultimately cured or corrected, Supplier may, in its reasonable discretion, determine that such circumstances, taken together, constitute a material breach.

Evaluations. At E-SCOPICS request, User will provide E-SCOPICS with written or oral report(s) of the results of User’s evaluation of the Services, including, but not limited to, a report of any errors that User has discovered in the Services.

Prohibited behaviour

The User is strictly prohibited from using the Solution for the following purposes

carrying out illegal or fraudulent activities or activities that infringe on the rights or safety of third parties
undermining public order or violating the laws and regulations in force;
aiding or abetting, in any form and in any way whatsoever, one or more of the acts and activities described above;
more generally, any practice diverting the Solution for purposes other than those for which it was designed, or for purposes other than normal use, it being specified that any use and activity deemed disproportionate shall be considered as not falling within normal use.

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

publishing, transmitting, disseminating or making accessible on or through the Solution, in any way which is prohibited by law, any information covered by secrecy, content which is infringing on the rights of third parties;
infringing laws and regulations on privacy, the protection of Personal Data or medical secrecy, notably the Data Protection Law;
posting or disseminating in any form whatsoever information or content including links to third party sites that are illegal and/or contrary to moral standards;
attempting to mislead other Users by impersonating them or by damaging the image or reputation of others;
modifying or falsifying any Data generated through the use of the Solution;
disrupting, slowing down, blocking or altering the normal flow of Data, modifying or altering or committing any other action having an equivalent disruptive effect on the functionalities of the Solution;
exploiting or disseminating, in any form whatsoever, information or content that has the effect of diminishing, disrupting or preventing the normal use of the Solution, interrupting and/or slowing down the normal flow of Data and information, or deliberately transferring items containing viruses, Trojans, spyware or any other program that is harmful or likely to impair the proper functioning of the Solution;
acting unfairly towards E-SCOPICS, other Users and Patients, and/or to harm their interests in any way;
disassociating or attempting to disassociate the software components of the Solution, and/or to reconstitute the logic of the Solution, to decompile or disassemble it for any reason whatsoever, or to carry out any action constituting reverse engineering.

In application of the ” Liability ” section hereafter, E-SCOPICS may take any action to suspend the access of the User to the Solution and if necessary to terminate his licence of use in case of non-compliance with this section. E-SCOPICS is free to use all technological, legal, operational or other means at its disposal, in order to obtain the forced execution of the provisions of the GTC, including but not limited to the blocking of the defaulting User’s Personal Account, without prejudice to any damages that E-SCOPICS may seek.

Commitments of the User in the context of the use of the Solution

As a medical device manufacturer, E-SCOPICS is bound by an obligation of post-marketing surveillance of the Solution, under which E-SCOPICS must actively and systematically collect, record and analyse relevant data on the quality, performance and safety of the Solution throughout its life, 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 E-SCOPICS any information or data relating to any incident, adverse event, risk of incident or adverse event, as well as any information likely to reveal a device deficiency noted in the context of the use of the Solution, so as to enable E-SCOPICS to comply with its legal and regulatory obligations as a manufacturer of medical devices.

WARRANTIES

E-SCOPICS expressly warrants that the Solution is a medical device within the meaning of Regulation (EU) 2017/745 on medical devices, CE marked, in accordance with the requirements of the applicable regulations on medical devices.

As such, E-SCOPICS warrants to Users that the Solution complies with the general safety and performance requirements laid down in the applicable regulation, and that the Solution shall function as described in the Documentation, as long as the User itself complies with the instructions regarding the use of the Solution.

E-SCOPICS guarantees that the Solution is designed so as to ensure the confidentiality and security of the Data entered, generated and processed by the Users on the Solution, in accordance with the provisions of the Data Protection Law.

On the other hand, E-SCOPICS does not control in any way whatsoever the use of the Solution by the User, the latter therefore being solely responsible for any action performed when using the Solution.

Likewise, E-SCOPICS cannot guarantee the accuracy, completeness, timeliness or other quality of the Data integrated and processed by the User on the Solution, the User being solely responsible for the accuracy and quality of the Data he processes on the Solution.

The User shall also ensure that the Data he integrates and processes on the Solution are free of viruses or any other component likely to cause damage to the Solution. The User acknowledges in this respect that the lack of security, integrity and/or quality of the Data would seriously harm the interests of the Patients and E-SCOPICS.

The User warrants E-SCOPICS in this respect and will compensate it for any damage that E-SCOPICS and/or the Solution may suffer as a result, without prejudice to the application of the provisions of the “Duration, suspension and termination” section hereafter.

LIABILITY

Access to and use of the Solution are under the full responsibility of the User. The use of the Solution enables ultrasound scans to be performed, but does not exempt the User from providing, where appropriate, medical advice and opinions, as a competent health care professional. The User is solely responsible for the medical opinion he provides to Patients when using the Solution.

The User is solely responsible for the proper use, with discernment and sense, of the Solution and the Data it contains and, in particular, the Health Data. The Solution cannot replace the User’s skill, knowledge and experience and is not intended to do so, which the User acknowledges and accepts expressly.

The User agrees that E-SCOPICS cannot, in any way whatsoever, hold any responsibility for Patient care which must be provided by the User or third parties associated to the latter.

The User undertakes to use the Solution in accordance with its intended purpose and the conditions and specificities of use provided by E-SCOPICS in the Documentation of the Solution. E-SCOPICS cannot be held liable for damage caused by the use of the Solution in the event of use beyond the scope of its purpose.

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

No advice or information, whether oral or written, obtained by the User when using the Solution is likely to create warranties not expressly provided for in the GTC nor to entail the responsibility of E-SCOPICS in the event of damage, of any nature whatsoever, caused to the User or to third parties as a result of the misuse by the User of the Solution, in breach of the provisions of this article and more generally of the failure to comply with the GTC.

The User (or, where applicable, the Client on whose behalf he performs his duties) is responsible for any damage to his computer system, to the Solution and/or its content, as well as for the loss of Data that may result from his use of the Solution. In this respect, the User (or, where applicable, the Client on whose behalf he performs his duties) is responsible for the implementation of anti-virus and other security measures for his computer system, in order to guarantee the security of the Data in accordance with the article ” Warranties ” hereinabove.

E-SCOPICS does not exercise any control, nor any supervision over the content and the Data processed on the Solution by the User, and therefore cannot be held liable in any way in this respect. The User is solely responsible for the analysis of the Data generated in the context of the use of the Solution, for their understanding and for any medical diagnosis made by the User of the Solution or any third party to whom the User may have communicated the Data.

To the fullest extent permitted by applicable law, E-SCOPICS expressly excludes its liability for any indirect, incidental, special or punitive damages, resulting from, or in connection with, access to the Solution, its use, its malfunction or its unavailability, whatever the nature and duration thereof. The User also acknowledges and accepts that the proper functioning of the Solution is dependent on the performance of its own IT tools (whether computer or tablet) and therefore E-SCOPICS cannot be held liable in any way should the performance of the Solution be hindered or impaired due to deficiencies in the User’s IT tools.

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

E-SCOPICS shall not be held liable, in general, in all cases where the non-performance or poor performance of its obligations provided for in these GTC would result from a case of force majeure or fortuitous event beyond its control.

INTELLECTUAL PROPERTY

The Solution belongs exclusively to E-SCOPICS. It is protected by intellectual property rights (such as, in particular, all copyrights, trademarks and any other existing or future French and international intellectual property rights), and by the following stipulations. All intellectual property rights relating to the Solution as well as all the elements of which it is composed (Documentation, copyrights, sounds, images, photographs, videos, writings, texts of all kinds, animations, programs, software, graphic charter, utilities, databases, etc.) are the full and complete property of E-SCOPICS.

The granting of a licence to use the Solution does not in any way confer on the User a right of ownership and/or an intellectual property right over the Solution, except for a non-transferable, non-exclusive right of access limited exclusively to the use of the Solution in accordance with its purpose and in compliance with these GTC and the Documentation.

The User undertakes not to infringe, directly or indirectly or through the intermediary of third parties with whom he is associated, the intellectual property rights of E-SCOPICS. Consequently, it is strictly forbidden to represent, reproduce and/or exploit the Solution, in whole or in part, in any form and by any means whatsoever, without the prior written consent of E-SCOPICS. The User undertakes not to copy, modify, disassemble, decompile, reverse engineer, alter, sell, rent, lend, disseminate, distribute and/or transfer all or part of the Solution, to create derivative works from these works, to authorise a third party to commit such acts or to allow them to do so, without the prior written agreement of E-SCOPICS.

In addition, the name “E-SCOPICS”, the logos, the domain names, the E-SCOPICS website and all other marks and/or trade names contained on the Solution are trademarks of E-SCOPICS. Therefore, the User expressly refrains from exploiting them in any way whatsoever, without the prior written consent of E-SCOPICS.

Failure to comply with the provisions of this article constitutes a violation of the intellectual property rights of E-SCOPICS and may result in civil and/or criminal proceedings.

PERSONAL DATA PROTECTION

As part of the management of access to the Solution by the User, E-SCOPICS is likely to implement a processing of their Personal Data concerning Users and Patients, including Health Data of the latter.

In order to preserve the rights and freedoms of the data subjects of the processing of Personal Data, E-SCOPICS has designed the Solution in compliance with the Data Protection Law and undertakes to comply with its provisions in the processing carried out via the Solution.

Processing of the User’s Personal Data by E-SCOPICS

For the purposes of managing access and any technical assistance or corrective maintenance services for the benefit of the User, E-SCOPICS may be required to process the User’s Personal Data.

In this context, E-SCOPICS acts as a data controller within the meaning of the Data Protection Law for the aforementioned purposes. The Personal Data of the User are strictly confidential and are processed by E-SCOPICS for the sole purpose described above.

E-SCOPICS undertakes not to disclose, transfer, rent or transmit the Personal Data of the User to third parties other than IT service providers which may intervene on its behalf, unless required by law or court order to do so.

The Personal Data of the User will be kept for the duration strictly necessary to achieve the purposes and in any case no longer that the duration of existence of the User’s Personal Account, and may be then archived for the time necessary to comply with the legal obligations of E-SCOPICS or for the purposes of proof for the establishment, exercise or defence of legal claims, then will be deleted by E-SCOPICS at the end of this period.

In accordance with the Data Protection Law, E-SCOPICS undertakes to take all necessary precautions to preserve the security and confidentiality of the User’s Personal Data. As such, E-SCOPICS implements all technical measures to prevent their destruction, loss, alteration, disclosure or unauthorized access by a third party.

In accordance with the Data Protection Law, the User has a right of access, rectification, limitation, deletion and portability of Personal Data concerning him. He also has the right to object to the processing, under the conditions strictly defined by the Data Protection Law, subject to the closure of his Personal Account, and the right to lodge a complaint with the competent supervisory authority if he considers that the processing carried out by E-SCOPICS constitutes a breach of his rights on his Personal Data.

The User can exercise his rights or ask any question relating to the protection of his Personal Data to E-SCOPICS, at the following address: dpo@e-scopics.com. The User must indicate precisely the subject matter of his request and the Personal Data concerned.

Personal Data of Patients

As a Solution accessible on-premise, i.e. the software is installed on the User’s computer equipment, E-SCOPICS is not in principle required to process the Patients’ Data.

However, the User acknowledges and accepts that E-SCOPICS is likely to act as a data processor, within the meaning of the Data Protection Law, for the processing of the Data of the Patients treated by the User (or the Client health establishment within which the latter carries out his functions) in the event that E-SCOPICS is called upon to carry out maintenance operations on the Solution during which E-SCOPICS accesses the said Data. E-SCOPICS undertakes in this context to comply with the obligations set forth in Article 28 of the GDPR, reproduced in the General Terms of Sale of the Solution.

In this context, the User (or the Client for whom the User intervenes while using the Solution) acts as the data controller of the processing of the Patients’ Data, which the User acknowledges and accepts. In this respect, the User (or the Client) expressly undertakes to comply with the requirements of the Data Protection Law.

Anonymisation of the Patients’ Personal Data

In the framework of the use of the Solution, the Parties expressly agree that E-SCOPICS shall be free to exploit and reuse the Anonymous Exploitable Data, notably for the purposes of carrying out research and development activities related to the Solution, as well as quality control of the device, under the conditions set forth in this Article.

To this end, the User expressly consents to the processing by E-SCOPICS of a copy of the Patient’s Data integrated and/or generated via the Solution, for anonymisation purposes with a view to this secondary use of data which is devoid of any identifying character.

In this context, the User however undertakes to inform the Patient of the possible processing of his Data by E-SCOPICS for anonymisation purposes, and to provide this information prior to any input of Data into the Solution and the performance of the ultrasound examination using the Solution, in order to enable the Patient to object to such processing of his Data if he so wishes.

If the Patient decides to object, the User undertakes to untick the box provided to track the objection of the Patient, thus ensuring that no unlawful processing of the Data is carried out by E-SCOPICS.

The processing of Personal Data for anonymisation purposes is based on the legal basis provided by the provisions of Articles 6.1 f) of the GDPR, namely the legitimate interest of E-SCOPICS as data controller and 9.2. j) of the GDPR, namely that the “processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.”.

Therefore, in compliance with the aforementioned provisions and Article 89.1 of the GDPR, according to which appropriate safeguards for the rights and freedoms of the data subjects must be put in place prior to the processing, E-SCOPICS undertakes to fully anonymise the Patient’s Personal Data prior to any secondary use, by implementing an irreversible process based on the near-impossibility, technically and mathematically, of reidentifying the Patients whose Personal Data was used for these purposes.

At the end of this irreversible anonymisation process, the information thus processed will be deprived of any identifying character, and may therefore be freely exploited and reused by E-SCOPICS as Anonymous Exploitable Data, which are excluded from the scope of the Data Protection Law.

DURATION, SUSPENSION AND TERMINATION

The GTC come into force as of their acceptance by the User and for the entire duration of the access and use of the Solution by the User.

Should the User use the Solution in a manner that does not comply with the GTC, fail to comply with the GTCs, or more generally in the event of a violation of the applicable laws and regulations, E-SCOPICS may take any legal steps to suspend or terminate, without prior notice or compensation, all or part of the User’s right to access and use the Solution.

E-SCOPICS may pronounce this suspension or termination without prejudice to all other rights, actions and remedies that E-SCOPICS may have in order to repair the damage that it may have suffered as a result of these breaches.

In the event of termination of the agreement binding the Parties, for whatever reason, the User undertakes to immediately cease all use of the Solution, unless otherwise agreed by E-SCOPICS.

UPDATING OF THE SOLUTION

Insofar as the Solution has been installed on the User’s devices, the latter acknowledges and accepts that the optimal functioning of the Solution may be conditioned by the installation of new versions in the context of updating the Solution. In this context, the User expressly undertakes to carry out the update of the Solution as soon as possible after receiving a notification requiring him to do so.

The User acknowledges that E-SCOPICS cannot be held liable of any malfunctioning of the Solution following E-SCOPICS’s notification to the User requesting the latter to install a new version of the solution made available by E-SCOPICS to correct a possible malfunction.

FORCE MAJEURE

Neither Party may be held responsible, or considered to have failed in its obligations, for any delay or non-performance, when the cause of the delay or non-performance is linked to a case of force majeure as defined in Article 1218 of the French Civil Code and by the case law of the French courts and tribunals.

The Parties shall inform each other of the occurrence of any such event and consult on the measures to be taken to remedy the consequences thereof. For as long as the Force Majeure lasts, the execution of the obligations set forth herein shall be suspended.

If the Force Majeure lasts for more than eight (8) weeks, the Party to whom it has been invoked may, in the absence of a better agreement between the Parties, terminate this agreement between the Parties by right, by registered letter with acknowledgement of receipt, without compensation and without further notice.

ENTIRETY – INVALIDITY

The GTC constitute the entire agreement between the Parties with respect to the conditions of use of the Solution. If one or more stipulations of the GTC are held to be invalid or declared as such in application of a law, a regulation – and in particular of the regulations of the European Union – or following a final decision of a competent jurisdiction, the other stipulations will keep all their force and their scope. E-SCOPICS will proceed without delay to the necessary modifications while respecting, as far as possible, the spirit of the GTC.

WAIVER

The fact that E-SCOPICS or the User does not avail itself of one or more provisions of the GTC shall in no case imply the renunciation by either of them to avail itself of them later.

APPLICABLE LAW AND JURISDICTION

The GTC shall be executed and interpreted in accordance with French law. All disputes and differences relating to the GTC, their interpretation, validity and/or execution, which are not amicably resolved within sixty (60) days from the first notification by registered letter with acknowledgement of receipt of the dispute, may be submitted by the most diligent Party to the materially and territorially competent courts.

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