End User License Agreement

END-USER LICENCE AGREEMENT

(user or evaluation license)

CAUTION!

PLEASE READ THE ENTIRE TERMS OF THIS DOCUMENT CAREFULLY BEFORE INSTALLING OR USING THERENVA'S PROPRIETARY SOFTWARE FOR THE FIRST TIME.

BY ACTIVATING THE OPTION "I ACCEPT THE TERMS OF THE LICENSE AGREEMENT", BY INSTALLING AND/OR USING THE SOFTWARE, YOU, AS THE LICENSEE ("THE END USER"), ACKNOWLEDGE THAT YOU HAVE ACCEPTED ALL THE TERMS OF THIS AGREEMENT.

IF YOU DO NOT ACCEPT THESE STIPULATIONS, DO NOT INSTALL AND/OR USE THE SOFTWARE.

The Software and related Documentation are provided by THERENVA, "the Editor", a company incorporated under French law, whose registered office is located at 74F rue de Paris, 35000 Rennes, France, registered with the Trade and Companies Register of Rennes, under the number 500 603 287 00037, for the sole purpose of use under the Terms and Conditions of this End-User License Agreement (the "Agreement").

THE FOLLOWING TRADEMARKS ARE DULY REGISTERED WITH THE INPI (FRENCH PATENT OFFICE): SOFTWARE NAMES, ENDOSIZE, ENDONAUT.

1. Definitions

" Key": means the protection key that activates the operation of the Software.

" Agreement": means this End-User License Agreement and any amendment thereto.

" Delivery Date": means the date on which the Key is made available to the End User, by any means whatsoever, in particular by e-mail.

"Documentation" : means the manual made available to the Customer, in electronic format, containing the essential procedures and/or instructions intended to facilitate the installation and use of the Software.

" Personal data": means any information relating to a natural person who can be identified, directly or indirectly.

" Environment": means the technical prerequisites of which the End User has been informed prior to the conclusion of the Agreement and defined in the Documentation corresponding to the End User's computer equipment (hardware(s), operating system(s), third party software(s)) and its evolutions and/or modifications, required for the use of the Software.

" Health Establishment": means an establishment whose missions are set by the Public Health Code. In this Healthcare Establishment Agreement, it designates the person responsible for processing the Data processed via the Software.

" License": means the user license(s) granted to the End User under the Evaluation License or the User License.

" Evaluation License": means the right to use the Software for the exclusive purpose of evaluation and testing, in accordance with the Terms and Conditions of the Agreement.

" User License": means the right to use the Software for the duration of the intellectual property rights relating thereto and in accordance with the Terms and Conditions of the Agreement.

" Software": means the computer program(s) in object code form, for which a License is granted under the Agreement, including the Documentation, any modified version of the Software and/or the Documentation made available under the Agreement; their partial or total reproductions.

" Media": means any storage medium of the Software - of THERENVA's choice - which is made available to the End User, including any provision made by electronic communication.

" Upgrade": means a modification of the Software which adds functionality or otherwise implements substantial additional capacity.

" Parties": means THERENVA and the End User.

" Patient": means the person concerned by a Personal Data Processing carried out by the Healthcare Establishment.

" Data Controller": refers to the legal entity (e.g. company) or natural person who determines the purposes and means of a processing operation, i.e. the objective and the way in which it is to be carried out.

" Sub-processor": refers to the natural or legal person who processes Data on behalf of another organization ("the Data Controller"), in the context of a service or provision.

" Processing of Personal Data": means any operation, or set of operations, relating to Personal Data, whatever the process used (collection, recording, organization, conservation, adaptation, modification, extraction, consultation, use, communication by transmission or diffusion or any other form of making available, reconciliation).

" End User": means the customer who acquires a Software License.

2. Object of the Agreement

The purpose of the Agreement is the Software User License that THERENVA grants to the End User and the conditions under which the End User may use the Software.

The Agreement between THERENVA and the End User consists of the following contractual package:

This End-User License Agreement;
The General Terms and Conditions of Sale;
The Documentation.

In the event of a contradiction between one and/or more provisions contained in any of these documents, the higher-ranking document will prevail.

3. Use of Licenses

In return for full payment of the price corresponding to the User License and in any case compliance with the Terms and Conditions of the Agreement, the End User has the personal, non-transferable and non-exclusive right to use the Software, under the following conditions:

The End User is authorized to:

install and use the Software in the Environment for its own needs; it is reminded that under the Evaluation License, the End User may only use the Software for the exclusive purpose of evaluation and testing;
install and use the Software on only one (1) workstation at a time or, where applicable, depending on the type of Software for which the License is taken out, according to the parameters expressly agreed between the Parties (period of use, number of uses, module(s) used);
make one (1) copy of the Software for backup purposes only, subject to reproducing all the intellectual property notices in/on the copy made, which remains subject to the terms of the Agreement;
more generally, install and use the Software in accordance with the instructions set out in the Documentation and with the Agreement.

Any violation of these Terms and Conditions of use of the license constitutes an infringement of the Software, subject to civil and criminal penalties.

4. Associated Services

The Agreement includes a maintenance and/or support service for the Software during the first year of use (from the date of supply of the License Key).

From the second year of use, updates are subject to a maintenance contract, a separate agreement between the End User and THERENVA or the distributor/reseller if applicable.

If the End User refuses to enter into a maintenance contract at the end of the first year, THERENVA cannot guarantee the security, performance and updates of the Software.

5. Software updates and major upgrades ("Upgrades")

THERENVA or the THIRD-PARTY SUPPLIERS (third party software or systems such as SOUP - Software of Unknown Provenance) may update or otherwise modify the Software, including, but not limited to, for the purpose of error correction and improvement of functions.

Such updates or modifications may remove or change the nature of the functionality or other aspects of the Software.

The End User acknowledges and agrees that such updates are made at THERENVA's sole discretion and that THERENVA may condition the continued use of the Software or acceptance of such updates or modifications.

All updates/modifications will be considered as part of the Software and will form part of it for the purposes of this Agreement. By accepting this Agreement, the End User agrees to install and use such update / modification if necessary, by THERENVA or its distributor.

The License provided here does not include Upgrades, which are subject to a separate offer.

6. Limitations

The End User is not allowed to:

use the Software for purposes other than those expressly provided for in the Agreement or beyond the limits defined by the latter or the Editor;
use the Software in a manner that does not comply with the specifications of the Documentation;
use the Software subject to the Evaluation License for production purposes; any use of the Software for production purposes implies the prior acquisition of a User License by the End User;
to allow a third party to use the Software, unless THERENVA has given its prior and express authorization and subject to the express and unreserved acceptance by the third party concerned, of all the Terms and Conditions of use of the Software; it being understood that in any case, the End User is responsible for the respect of the terms of the Agreement both by the third party and by the employees concerned and guarantees THERENVA against the actions of these persons, if such actions contravene the provisions of the Agreement;
sub-license, assign, distribute, make available or otherwise transfer and/or share all or part of the rights granted on the Software by any means whatsoever, unless THERENVA has given its express prior authorization:
modify, decompile, reverse engineer, disassemble, translate, recreate the Software even partially, or attempt or allow third parties to perform such acts.
In the event that the End User wishes to obtain information enabling the interoperability of the Software with other software, the End User undertakes to consult THERENVA or its distributor before any decompilation in order to find out if such information is not quickly and/or easily accessible, and in this case, to limit the reproduction of the code or the translation of the code to only those parts of the program necessary for the implementation of the aforementioned interoperability;
attempt to modify, circumvent or provide the method or means of circumventing any deactivation mechanism that prevents the use of the Software after the expiry of the License or subscription period.
in general, use the Software in breach of any provision of the Agreement and/or any legal and/or regulatory provision, in particular any provision relating to the regulations on medical devices and the protection of personal data.

In any event, the End User is solely responsible for the use, management and control of the use of the Software.

7. Special risks related to the use of the Software in the medical field

The End User acknowledges that he has a substantial obligation of care in relation to the use of the Software in the health sector, given the relative reliability of computer tools, in particular in their interpretation of the data received, produced and displayed by the Software.

The Software is not intended to be used in any case where accuracy and/or continuous performance condition the risk of death during surgical, medical, resuscitation or any other care.

Any quality or compliance problem that could cause a risk or serious incident involving the death or deterioration of the state of health of an individual must be reported to the manufacturer or its local representative within the regulatory timeframe. The latter will take the necessary steps, if necessary, to report the event to the relevant Competent Authority(ies).

8. Warranty – Compliance

The Software licensed under the Agreement is a medical device.

As a manufacturer of medical devices, THERENVA guarantees to the End User the safety and performance of the said devices throughout their lifetime.

THERENVA guarantees to the End User that the regulations applicable to medical devices in the relevant sales territories are complied with.

As such, medical devices carry the "CE" marking.

THERENVA's medical devices have also received a certificate attesting to their performance as well as their compliance with essential safety requirements.

9. Collaboration of the Parties

In return for the rights granted to him/her under this Agreement, the End User undertakes to:

Pay the price of the License;
Make his best efforts to inform THERENVA or its distributor, free of charge and within a reasonable period of time, of his experience resulting from the use of the Software, in particular but without being limited to, all errors or defects detected, inconsistencies between the program and the associated Documentation, restrictions to the applications of the Software which have not been mentioned in the associated Documentation and any developments and improvements which may be made to the Software;
To collaborate actively with THERENVA for the purposes of performing the Agreement;
To respond as soon as possible to requests for information made by THERENVA;
To train its staff in the use of the Software.

10. Protection and safety measures

The End User undertakes to use its best efforts and to take all necessary measures to prevent access to the Software by any unauthorized person as well as any unauthorized copying, publication, disclosure and/or distribution of the Software, in whole or in part, in any form whatsoever. The End User acknowledges and accepts that the Software contains confidential information and business secrets of THERENVA, and that any unauthorized use and/or copying would be detrimental to THERENVA.

The User undertakes not to disseminate or use computer programs or hardware with destructive features, such as: a time bomb, virus, software lock, software blocking/disabling device, malware, worm, Trojan horse, bug, error, defect or backdoor software, capable of accessing, modifying, deleting, damaging, disabling, interfering with or damaging the Software or its environment (computer, network, data...).

The Software does not contain any program routines, devices, code or instructions (including any code or instructions provided by third parties) or other undisclosed functionality, including but not limited to:

a time bomb, virus, software lock, software locking/disabling device, malware, worm, Trojan horse, bug, error, defect or backdoor software,

which is capable of accessing, modifying, deleting, damaging, disabling, interfering with or damaging:

the software, any computer, network, data or other stored information, computer programs/systems.

with the exception of functionality that allows:

(i) the verification and tracking of licenses,

(ii) to offer the User online updates,

(iii) ) the collection of bug reports and anonymized statistical data.

None of these routines allows remote control without the express acceptance of the User by means of a tool such as TeamViewer.

It is up to the End User to take all appropriate measures to protect his own data and materials from contamination by viruses or other forms of attack.

11. Intellectual Property

The License granted by THERENVA or its distributor to the End User is strictly limited to the rights expressly granted under the Agreement. Under no circumstances may the Agreement be interpreted as a sales contract.

THERENVA declares that it is the owner of all intellectual property and economic rights to the Software and the related prerogatives.

THERENVA declares that, to its knowledge, nothing prevents it from entering into the Agreement, and that the Software does not constitute in France, a counterfeit of a pre-existing work. The End User undertakes to inform THERENVA or its distributor without delay of any use of the Software which is illicit or contrary to the Agreement of which he may be aware. If, following this information, THERENVA decides to take action against a third party, the End User will provide THERENVA with all necessary assistance.

THERENVA undertakes to ensure at its own expense the defense of the End User against any allegation of infringement of copyright or other intellectual property rights brought by a third party and relating to the Software, provided that the End User:

has notified THERENVA in writing of the existence of this allegation as soon as it becomes aware of it,
has allowed THERENVA to have sole control over the defense and any negotiations for an agreement, and
works together with THERENVA for these purposes.

If a complaint, a threat of action or an action is directed against the End User as a result of the use of the Software, or if THERENVA considers that this could be the case, THERENVA will, at its discretion and at its own expense, either (i) replace the relevant element of the Software with a substitute element of equivalent functionality, or (ii) refund the amount received by THERENVA under the Software License in question; the License in question will then be terminated.

THERENVA will pay the damages and interest to which the End User is condemned due to an act of counterfeiting of the Software as soon as the condemnation pronouncing them has become final, as well as the compensation and costs of any kind borne by the End User to ensure his defense, including legal fees, it being understood that THERENVA's entire liability and the exclusive compensation of the End User for the infringement of a property right relating to the Software may under no circumstances exceed the price received by THERENVA under the Software License in question.

THERENVA expressly disclaims all liability when the allegation is based on:

the use of a version of the Software which is not the most recent version, when such an infringement could have been avoided by using the current version of the Software;
any modification of the Software made by the End User or by a third party acting on his behalf;
any use of the Software that does not comply with the Documentation and/or the Agreement;

any use of the Software in combination with hardware, operating systems and/or software other than those relating to the Environment.

The present article sets out THERENVA's entire liability and the exclusive remedy of the End User with regard to the infringement of an intellectual property right or any other property right; THERENVA cannot be held liable beyond the stipulations of the present article.

The Software contains modules and libraries distributed under "open source" licenses, the list of which is available on request. THERENVA guarantees that the licenses under which these modules or libraries are distributed, authorize THERENVA to incorporate them into the Software, and that none of these modules or libraries have a viral effect. THERENVA will make its best efforts to ensure the continuity of this guarantee over time. If the license of a module or library should evolve and this evolution makes it impossible to incorporate them into the Software, THERENVA will take care of it.

12. Privacy

Within the framework of the Agreement, each of the Parties may have access to information considered by the other Party as confidential ("Confidential Information").

Confidential Information includes, among others, data, diagrams, specifications, documentation, software lists, object or source codes, prices that the End User may have received in connection with the Software (other than the ideas and principles underlying the Software). The End User hereby agrees to use such information solely in accordance with the provisions of the Agreement and not to disclose under any circumstances, either during or after expiry or termination of the Agreement, the information, directly or indirectly, to any third party without the prior written permission of THERENVA.

Each party undertakes to respect and to ensure that its subcontractors, collaborators or any other third-party partner respect the confidentiality of information and documents presented to it as such by the other party.

"Confidential Information" does not include information (i) which has entered the public domain before or after its disclosure, through no fault of the receiving party, (ii) which the receiving party can prove to have known independently and lawfully before its disclosure, (iii) developed independently by the receiving party without the receiving party having had access to the Confidential Information.

The obligation of confidentiality under this Article shall remain in effect for a period of ten (10) years after the disclosure of each Confidential Information.

13. Protection of personal data

Processing of personal data

When using the Software:

The Healthcare Establishment or Healthcare Professional is responsible for processing Personal Data relating to natural person Users of the Software and relating to Patients.
THERENVA is required, on the instructions of the Data Controller, to carry out certain operations on behalf of the Data Controller as a Sub-Contractor.
THERENVA's distributor acts as a co-subcontractor.

The Company undertakes to ensure, for the part which is under its responsibility, the protection of Personal Data in accordance with the European and French regulations applicable to it in terms of protection of Personal Data, and in particular:

EU Regulation 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of individuals with regard to the processing of personal data and on the free movement of such data, known as the "General Data Protection Regulation" (the "GDPR");
Law 78-17 of January 6th 1978, as amended, relating to Information Technology, Files and Freedoms (the "Loi Informatique et Liberté");

The GDPR and the French Data Protection Act are hereinafter together referred to as the " Regulations".

It is also reminded that it is the responsibility of any Healthcare Establishment or Healthcare Professional to respect all of its obligations in terms of Personal Data and Patient information, particularly in terms of hosting health data as provided for in Article L1111-8 of the French Public Health Code.

Categories of personal data processed

In accordance with the Regulations, the User is informed that the following personal data may be processed by THERENVA or its distributor:

Identification data (surname, first name (of the patient, of the practitioner), date of birth, gender, ID number);
Administrative data relating to the patient (date of surgery, type of method used for the operation, description of the operation);
Health data (medical images, medical reports).

Purposes of the Treatments

THERENVA or its distributor processes the aforementioned categories of Personal Data for the following purposes:

Assistance, preventive, corrective and evolutionary maintenance, and monitoring of software and hardware solutions;
Reversibility, where applicable.

Legal basis

The processing of the Patient's Health Data is necessary for the purposes of the Patient's health care.

The processing is necessary for the purposes of managing health care systems and services under a commercial agreement or contract between THERENVA or its distributor and the health care facility or health professional.

Retention period of the collected data

The Personal Data necessary for processing will be kept in accordance with the data management policy of the health facility or health professional.

The technical traces are available within the limits of the storage capacity of the site's server.

Recipients of collected data

In compliance with the rules on medical secrecy and the sharing of Health Data covered by medical secrecy, health information is intended exclusively:

To Healthcare Professionals;
To members of staff of specifically authorized technical service providers, in strict compliance with their missions, solely for technical management purposes;
To any persons authorized as approved third parties (courts, arbitrators, mediators, ministries, etc.).

The Data Processors and Subcontractors each guarantee, as far as they are concerned, that the Personal Data will not be transmitted to any unauthorized third party.

Security of Personal Data

THERENVA or its distributor undertakes to put in place the necessary technical and structural measures to ensure the protection of Personal Data (in particular to prevent fraudulent access to or use of this Data, and to prevent any loss, modification or destruction of this Data).

THERENVA's obligations towards the data controller

THERENVA is committed to:

Apply the principles of data protection from the very beginning of the Services it provides.
Process the Data only for the purpose(s) which is/are the subject of the sub-contracting.
Process the Data in accordance with the written instructions of the Data Controller. If THERENVA considers that an instruction constitutes a breach of the GDPR or of any other provision relating to data protection of Union law or of the law of the Member States, it shall immediately inform the Data Controller. In addition, if THERENVA is obliged to transfer Data to a third country or to an international organization under Union law or the law of the Member State to which it is subject, it must inform the Controller of this legal obligation prior to the processing, unless the law concerned prohibits such information for important reasons of public interest.
Guarantee the confidentiality of the Personal Data processed and, to this end, ensure that its staff authorized to access and process Personal Data under this Agreement has been made aware of the guidelines on the protection of Personal Data and has undertaken to comply with them.
Ensure that its personnel authorized to access and process the Data in the context of this Agreement has received the necessary training on the protection of Personal Data.
Assist the Data Controller in carrying out impact assessments relating to the protection of Personal Data.
Subcontracting: THERENVA may use another subcontractor, hereinafter referred to as "the sub-contractor", to produce specific processing activities. In this case, it shall inform the Data Controller in advance and in writing of its proposed sub-contracting. This information must clearly indicate the Personal Data processing activities to be subcontracted, the identity and contact details of the sub-contractor and the dates on which the sub-contracting contract takes effect and ends. The Data Controller has fifteen (15) working days from the date of receipt of this information to present its objections.
Subsequent sub-contracting may only be carried out if the Data Controller has not raised any objection within the agreed period.
The subsequent subcontractor is obliged to fulfil the obligations of the Agreement on behalf of and according to the instructions of the Data Controller, under the direct control of THERENVA.
THERENVA must ensure that the sub-contractor provides the same sufficient guarantees that appropriate technical and organizational measures have been implemented so that the processing meets the requirements of the GDPR.
If the sub-processor does not fulfil its obligations with regard to the protection of Personal Data, THERENVA remains fully responsible and must either have the necessary corrective action taken to ensure that the sub-processor complies with its obligations to process the Personal Data in accordance with the present conditions or change the sub-processor with the consent of the Data Controller.
Assistance of the Data Controller in its procedures: as far as possible, THERENVA assists the Data Controller in its reporting procedures to the supervisory authority.
Right of information of the persons concerned: it is the responsibility of the Data Controller to inform the natural or legal persons whose Personal Data it processes of their rights in terms of the protection of Personal Data. If necessary, at the express request of the Data Controller, THERENVA assists the latter in the extraction of Personal Data enabling it to fulfil its obligation to inform the said persons.
Exercise of the rights of individuals: as far as possible, THERENVA assists the Data Controller in fulfilling its obligation to respond to requests to exercise the rights of individuals or legal entities whose Personal Data is processed within the framework of the Agreement: right of access, rectification, deletion and opposition, right to limit processing, right to data portability, right not to be subject to an automated individual decision (including profiling). To this end, it is agreed that if natural or legal persons submit such requests to THERENVA, the latter will forward them to the Data Controller, upon receipt.
Notification of Personal Data Violations: THERENVA will notify the Data Controller, by telephone and then by email at dpo@therenva.com with an L.R.A., of any violation of Personal Data, within a maximum of eight (8) working hours after becoming aware of it.
Anonymization of data: during the period of application of the Agreement, THERENVA undertakes to anonymize the Personal Data according to the written specifications of the Data Controller who takes full responsibility for this action and the consequences it may have on the current processing of Personal Data.
Data Protection Officer: the Data Protection Officer appointed by THERENVA can be contacted at dpo@therenva.com.
Documentation: upon request, THERENVA will provide the Data Controller with the documents which demonstrate compliance with its obligations as defined herein and allow audits or inspections to be carried out by the Data Controller or its representatives. THERENVA contributes to these audits or inspections.

Obligations of the data controller towards THERENVA

The Data Controller undertakes to:

Provide THERENVA and update throughout the duration of the Agreement the name and contact details of its representative and, if applicable, its Data Protection Officer (DPO) who will be THERENVA's privileged contact for addressing subjects falling under the GDPR (excluding operational execution of the Services).
Provide THERENVA as soon as the Agreement is concluded and to update throughout the duration of the Agreement all the information required on the Processing of Personal Data entrusted to THERENVA by the Data Controller, namely: the purpose and duration of the Processing, the nature and purpose of the Processing, the type of Personal Data, the categories of Persons concerned and the categories of Processing, as well as, where applicable, the transfers of Personal Data to a third country within the meaning of the applicable regulations with the identification of the third country(ies)). If the Customer does not transmit the said required information, the Customer may be held liable under the Regulation. The Customer is obliged to rectify the situation with the Service Provider without delay.
Communicate in advance in writing to THERENVA any additional instructions concerning new Treatments linked to changes in the scope of the Services. These instructions must be documented, clear, up to date and easily identifiable and will be deemed to have been transmitted by those Persons authorized for this purpose by the Data Controller to the Persons authorized by THERENVA under the Agreement.
Ensure, prior to and during the entire duration of the processing, that its obligations and those of THERENVA as provided for in the Regulations are complied with,
Ensure that THERENVA's requests for treatment are answered in a timely manner throughout the duration of the Agreement.
Supervise the processing of the Data and to carry out audits or inspections of THERENVA if it deems them necessary.
Determine and implement, taking into account the nature, scope, context and purposes defined by THERENVA itself and the risks to the rights and freedoms of the persons concerned, all technical and organizational measures appropriate to the Processing (including the subscription of additional or complementary services to the scope defined in the Agreement, if necessary) and provide them with the necessary guarantees to meet the legal and regulatory requirements in force and to protect the rights of the persons concerned.
In the event of a violation of Personal Data, notify the competent supervisory authority of the violation in question as soon as possible and no later than 72 hours after becoming aware of it (beyond that, the reasons for the delay must be justified), unless the violation in question is not likely to create a risk for the rights and freedoms of individuals.

In addition to the obligations imposed on the Data Controller in his contractual relations with THERENVA, he guarantees more generally to comply with all the obligations incumbent on him by virtue of the regulations relating to Personal Data.

In particular, it is responsible for keeping the Record of processing activities carried out under its responsibility and for complying with the provisions of the Regulations relating to the respect of the rights of data subjects.

14. Warranty and liability

The End User is responsible for the installation and use of the Software as well as for the results that are obtained.

Under the Evaluation License, the Software is provided "as is", without any warranty, express or implied.

Within the scope of the Evaluation License, and during the term of the Evaluation License, THERENVA warrants exclusively that (i) the Software is provided on a Media free of manufacturing defects (if any), and (ii) the unmodified Software - provided that it is used strictly in accordance with the documentation and the Agreement - is substantially in accordance with the specifications set forth in the documentation.

In the event of non-compliance within the framework of the contractual guarantee as defined in the previous paragraph, the End User returns the defective Software to THERENVA or its distributor and THERENVA or its distributor undertakes, at its discretion, to replace the defective Software - it being understood that the replacement Software will then only be guaranteed for the remaining guarantee period - or to refund the amount received by THERENVA or its distributor for the Software License, such refunding entailing the termination of the License.

The End User acknowledges and accepts that the above commitments constitute his exclusive remedy under the warranty.

This guarantee is excluded in the event of any modification of the Software not carried out by THERENVA and/or any use of the Software in an environment other than the Environment, in particular in the event of a problem in the context of the interaction of the Software with software not supplied by THERENVA.

The above warranty is exclusive of any other, and the End User waives any other warranty, whether express or implied, including any warranty in terms of marketability and suitability of the Software for a particular purpose. The Software is not a substitute for or in lieu of the End User's training, experience and/or knowledge.

THERENVA or its distributor is bound by an obligation of means under the Agreement.

THERENVA is not bound by any obligation to backup and/or archive data, which the End User is responsible for regularly backing up.

Under no circumstances:

THERENVA, its legal representatives, its distributors/resellers or affiliates, its employees cannot be held liable for any indirect, consequential or incidental damages suffered by the End User, its users and/or a third party (in particular in the event of loss of profits, commercial disruption, loss of data and/or files) as a result of the use or impossibility of use of the Software or related written elements, even if THERENVA has been advised of the occurrence of such damages.
the amount of compensation for which THERENVA may be held liable may not exceed the amount received under the License, whatever the nature and legal basis of any action taken against THERENVA.

15. Right of inspection

The Parties agree that THERENVA, after having notified the distributor and the End User in writing - subject to three (3) working days' notice in France - reserves the right to carry out or have carried out at its own expense an audit on parts and/or on site, in order to verify the conformity of the use of the Software. The End User undertakes to cooperate with THERENVA or the service provider designated by THERENVA for this purpose, in order to enable THERENVA to carry out this audit under optimum conditions; it being understood that THERENVA will endeavor not to disrupt the company's activity.

If the audit mentioned above shows that one or more additional licenses are required for the End User to use the Software in accordance with the provisions of the Agreement, the End User will be obliged to pay THERENVA or the distributor immediately for the said license(s) at the price then in force, without prejudice to the provisions of article 13 and other rights which THERENVA may claim.

16. Duration, termination

The Evaluation License shall take effect on the Delivery Date for the specified term, unless terminated early in accordance with the terms below.

The Use License shall take effect on the Delivery Date for the duration of the legal protection of the rights pertaining thereto, unless terminated earlier under the terms set out below.

The End User is not authorized to use the Software qualified as a medical device beyond the duration of its life as specified by the publisher and mentioned in the accompanying documentation;

In the event of a breach by one of the Parties of these contractual obligations which is not remedied within thirty (30) working days from receipt, or failing this, from the first presentation of the registered letter with acknowledgement of receipt notifying the breach in question, the other Party may terminate the Agreement, by registered letter with acknowledgement of receipt, without prejudice to any damages to which the latter may be entitled.

Upon termination of the License, for any reason whatsoever:

the User immediately ceases to use the Software, removes it and any copy made of the computer memory, destroys it or returns it to THERENVA or its distributor.
upon written request from THERENVA, the End User certifies in a written document duly signed by his/her legal representative that the stipulations of this article have been respected, within five (5) days of THERENVA's request.

In addition:

upon written request from the other party, each party undertakes to return or destroy any Confidential Information communicated by the other party;
the stipulations relating to confidentiality, intellectual property, liability, right of control and other stipulations which by their nature are intended to survive the end of the Agreement will remain in force for the duration necessary to give them the intended effect.

17. Compliance with export laws and regulations

It is the responsibility of the End User to act in accordance with French, European and international regulations applicable to exports.

The End User may not, directly or indirectly, transfer or participate in the transmission of the Software in a country where such an operation is prohibited or subject to obtaining a license or administrative authorization without first obtaining the said license or authorization.

Furthermore, the End User guarantees that he is not subject to any special measures relating to the export or import of products in his country, and that he is not subject to the stipulations of a country prohibiting the import of software.

The Parties undertake, as far as they are concerned respectively, to comply with all legal and regulatory requirements in force, in particular those relating to data processing, files and freedoms.

18. Assignment

The End User is prohibited from assigning, contributing or otherwise transferring - totally or partially - the rights and obligations resulting from the Agreement, whether in return for payment or free of charge, without the express and prior permission of THERENVA or its distributor. A change of majority in the capital of the End User, spin-offs, mergers, absorptions, contributions to a third party, and in general, any operation tending to transfer the License to a third party are considered as a transfer.

THERENVA reserves the right to assign, transfer or contribute to any third party, in any form whatsoever, the rights and obligations resulting from the Agreement and undertakes to inform - as far as possible - the End User.

19. Applicable law, competent jurisdiction

The Agreement is governed by French law. It must be applied and interpreted in accordance with this law.

The Parties declare their intention to seek an amicable solution to any difficulty that may arise in connection with the application or interpretation of the Agreement.

In the event of a dispute, the Commercial Court of Paris, France, shall have sole jurisdiction, notwithstanding plurality of defendants or appeal in warranty, even for emergency or protective proceedings.

20. Partial nullity

In the event that certain provisions of this Agreement are inapplicable for any reason whatsoever, including as a result of an applicable law or regulation, the Parties shall remain bound by the other provisions of this Agreement and shall endeavor to remedy the inapplicable provisions in the same spirit as that in which they were concluded.

21. Various stipulations

The Parties are independent legal persons, acting in their own name and under their sole responsibility. Each Party therefore refrains from entering into a commitment in the name and on behalf of the other Party, which it may not under any circumstances replace, except within the limits strictly necessary for the performance of the Agreement.

If one or more stipulations of the Agreement are held to be illegal, null or unenforceable in whole or in part, pursuant to a law, a regulation or following a final decision of a competent court, the stipulation(s) in question will be modified in order to make it (them) legal, valid and applicable and the other stipulations will retain their full force and scope, unless the very object of the Agreement disappears as a result.

The fact that one of the Parties tolerates a breach by the other Party of one of its obligations under the Agreement shall not be interpreted for the future as a waiver of the obligation in question. In order to be effective, any waiver must be the subject of an amendment in accordance with the terms of this article.

The Agreement constitutes the entirety of the agreements between the Parties on the date of entry into force. It cancels and replaces any previous or contemporaneous proposal, agreement or other oral or written commitment relating to the same subject matter. Any modification of the Agreement must be the subject of an amendment signed by a duly authorized representative of each of the two Parties.

Unless otherwise stipulated in the Agreement, the files, data, messages, computerized registers recorded in the computer systems of THERENVA or its distributor, will be accepted as proof of the acts and facts between the Parties. The preservation of the registers will be presumed, in the absence of proof to the contrary, to have taken place under reasonable conditions of security if the messages, data and other documents are systematically recorded on a reliable and durable medium.

Any notification between the Parties during the course of the Agreement shall be made in writing, in registered form with acknowledgement of receipt.

22. Language of the Agreement

The Agreement is drawn up in French.

If a translation of the Agreement is available, only the French language version shall be binding.

In addition, all communications between the Parties relating to the performance of the Agreement shall be in French.