TERMS OF USE

MicroPort Remote Monitoring System

Thank you for choosing the MicroPort Remote Monitoring System.

Please read these Terms of Use carefully before you start to use our Website:

Access to this service is restricted to authorized users only. By using the Website or by clicking to accept or agree to the Terms of Use when this option is made available to you, you accept and agree to be bound and abide by these Terms of Use and our Privacy Policy, which you can find here.

By virtue of your usage of these services you enter into a binding license agreement with SORIN CRM SAS (hereinafter “MicroPort”, the “Provider”, “we”, or “us”), with registered address at 4 Avenue Réaumur, 92140 Clamart, France. You agree to use this Website for lawful purposes only, and in a manner that does not infringe the rights of, or restrict or inhibit the use of this Website by any third party. You certify that you are authorized to provide your informed consent.

1. Description of Services

1.1 The following terms and conditions (hereinafter referred to as "Terms of Use") apply to every registered user of the MicroPort Remote Monitoring System exclusively operated by MicroPort.

1.2 The RMS provides certain information in relation to the cardiac device manufactured by MicroPort following successful implantation on the Patient, which allows the performance of telemedicine or remote surveillance acts (the “Services”) by Health Care Professionals (our “Customers”).

1.3 The Provider’s service enabling the telemedicine acts or remote surveillance of the implanted devices is called the “SmartView RMS” or the “RMS”. Please note, however, that the RMS is not an emergency system and does not provide medical advice. The “SmartView RMS devices” designate accessories of RMS that are used by Patients for transmitting data from their cardiac devices.

1.4 As part of the Services, Customers gain access to data transmitted to the SmartView RMS by the implanted device in one of the following situations: when the implanted device raises an alert, when the Patient initiates a manual transmission, or at a specific date programmed by the Customer. The data constitutes Patient Data and is subject to the protection of the relevant professional duty of confidentiality and of applicable data protection law.

1.5 Relevant Patient Data obtained through the SmartView RMS devices then becomes available to the Customer on this Website, with the possibility to download Patient reports. Depending on the means of communication defined by the Customer, unencrypted system notifications and alarms can be sent directly by email or SMS text message or fax to an address and/or number specified by the Customer.

1.6 The purpose of these Terms of Use is to establish the conditions under which you, as a Customer and User of our Services, will be able to:

· Gain access to the remote monitoring via our secure SmartView RMS Website;

· Retrieve the data you need for the appropriate care and treatment of your Patients.

2. User Registration

2.1 By completing the User Registration procedure on our Website, you enter into a user agreement with us and thereby accept the Terms of Use as basis of the user agreement. You or a legal representative of your healthcare facility have also entered into an RMS agreement with MicroPort (the “RMS Agreement”), which governs the terms of the RMS service and covers applicable data protection provisions.

2.2 The User Registration requires the submission of certain mandatory information before you can access the Website for the first time (e.g. first and last name, email address and a chosen password). These information have been entered by one of the local SmartView RMS administrators at your Healthcare Facility. We will send you a verification email to your email address. In order to complete the registration process, you will need to activate your account by clicking the verification link in the email.

2.3 After successful User Registration, you can login to the Website by entering your username and password.

French Healthcare Professionals have the possibility to sign up through Pro Santé Connect instead of username and password. Pro Santé Connect is a teleservice implemented by the Agence du Numérique en Santé (ANS) contributing to simplify the electronic identification of healthcare professionals. Users can connect using their e-CPS mobile application or their CPS card, with a card reader and the necessary components.

2.4 As a Customer, you must not let any third party have access to the access credentials you chose upon registration and you are obligated to inform us immediately after becoming aware that non-authorized third parties have possession of or access to your credentials. You are personally liable for any use and/or activity that is being carried out under your account in accordance with the statutory legal provisions. You hereby undertake to protect the confidentiality and security of all the confidential, health-related and personal data you may have access to even after the termination of the relationships with the people associated with such information.

3. Obligations of Customer

3.1 You will only use your own true IP address/user agent identity and will not mask your activities under the IP address/user agent string of another service. You will not transfer any approved IP address or user agent to any party without the Providers’ express written consent. Any misconduct that would constitute a threat to our Website’s security will trigger the termination of your account.

3.2 Due to the sensitive nature of the diagnostic and personal data shared on Patients and their health, you commit to their highest protection following the relevant professional duty of confidentiality and all applicable data protection laws, especially the General Data Protection Regulation (GDPR). Please consult our Privacy Policy and the RMS Agreement for more details.

3.3 Following the above, you shall be solely liable for conformity with the applicable professional duty of confidentiality and with applicable data protection laws, and shall be responsible for informing the patient comprehensively in accordance with the relevant statutory requirements on the processing of patient data by the Provider in relation to the Service and where necessary for obtaining a corresponding declaration of consent.

3.4 Where MicroPort CRM SmartView devices are being used by the Patient along with RMS Services, you shall bear the responsibility for explaining the functioning of the SmartView device appropriate for the type of cardiac implant, and its specificities to the Patient. This duty shall include, among others, explaining to the Patient the setup and functioning of the SmartView device. In addition, the Patient must clearly understand that remote monitoring does not constitute an emergency information system and does not eliminate the need for the Patient to contact or consult with his physician in case of any doubt or emergency.

3.5 You alone shall be responsible for the diagnosis and treatment of the Patient. The Provider supplies the Service to the Customer, without making any evaluation or interpretation of medical data, and without making any recommendation or interfering in any way with any medical advice and/or the treatment of the Patient.

4. Obligations of Provider

4.1 The Provider shall take all appropriate measures in order to ensure that the input into the SmartView Website is processed correctly, according to best practices and following any applicable regulations.

4.2 The Provider shall apply state of the art security standards, procedures and systems available in order to guarantee the security and protection of the data made available throughout the Services.

4.3 The Provider is responsible for the successful transfer of data from the SmartView device to the Provider's Website. However, such transfer will depend on the available network, the Internet connection and the good functioning of the SmartView device. This obligation is construed as an obligation of means only. The Customer accepts that the Service may become temporarily unavailable or out of service for a variety of circumstances, such as (but not limited to): scheduled maintenance, system updates, system malfunctions, network overload, faulty hardware, interrupted or defective transmission, attacks against the network, force majeure and reasons beyond the control of the Provider, which could not have been reasonably foreseen by the Provider.

5. Rights of Provider

5.1 In order to enable the consistent improvement of the Services, the Provider may make technical and design changes, and may in particular make improvements and adjustments in order to ensure conformity with current legislation and regulations or emergency rules (e. g. due to a pandemic), on condition that such changes should be reasonable.

5.2 The Customer expressly accepts and will not oppose that:

· The Provider has the right to continuously change the functionality and underlying structure of provided functions, UI and/or HTML elements, especially the user interface of the Website;

· The Provider has the right to automatically block users or IP addresses, to prevent any malfunctioning or performance reduction;

· The Provider may revoke any permission granted at any time for any reason and the Customer agrees to immediately cease collection and use of data collected on notice of such revocation.

6. Liability

6.1 Unless otherwise stipulated in these Terms of Use, the Provider shall be liable following the relevant liability provisions contained in the RMS Agreement, in case of a breach of its contractual obligations. Any liability on the part of the Provider for any damages shall arise only in the case of a willful misconduct or gross negligence. For any damages incurred due to the gross negligence of a vicarious agent of the Provider, the liability shall be limited to damages that may reasonably be expected in such cases.

6.2 In any case of simple negligence, the Provider shall only be liable for damages relating to injury to life, limb or health and for damages resulting from a breach of an essential contractual obligation (i.e., an obligation whose primary end is to facilitate the orderly fulfillment of the contract and on whose observance the Customer can generally rely), in which case the liability shall be limited to damages that may reasonably be expected in such cases. In such cases and to the extent permitted by law, Provider's liability shall be limited to the amounts received by the Provider under the terms of the RMS Agreement if applicable, excluding repayment of fees.

7. Termination

7.1 Either Party may terminate for any reason the SmartView RMS Services online by sending such a termination in writing to the other Party with a ninety (90) days’ notice period. The Customer may do so by contacting local MicroPort Customer Service (Contact Us information on SmartView Website Login page).

7.2 The Provider may also immediately terminate access to the SmartView RMS Services online for any particular implanted device in either of the following cases:

· Explantation of the device or termination of its use*;

· Unallowed use of the SmartView device or its RMS Services;

The Provider will declare this termination effective in writing by letter or email.

(*) In that case, the Customer may still access Patient data collected before the explantation of the device.

7.3 The Services available online (including the reports generated) will end automatically upon termination of the SmartView RMS.

7.4 Following termination of the Services and of these Terms of Use, the Customer shall be responsible for informing the Patients thereof and for ensuring the continuity of the Patients’ treatment and their appropriate medical follow-up. Any health hazard arising from the termination will be construed as gross negligence on behalf of the Customer and engage the latter’s liability towards Patients. The Customer must explicitly inform the Patient that his cardiac device data are no longer being transmitted online and monitored remotely through the SmartView RMS Services.

8. Disclaimer of Warranties

8.1 Your use of the Website, its content and any Services or items obtained through the Website is at your own risk. The Website, its content and any Services or items obtained through the Website are provided on an “as is” and “as available” basis, without any warranties of any kind made by the Provider, either express or implied.

8.2 As a Customer, you understand that the Provider cannot and does not guarantee or warrant that files available for downloading from the Website will be free of viruses or other destructive code. You are responsible for implementing sufficient procedures and checkpoints to satisfy your particular requirements for anti-virus protection and accuracy of data input and output, and for maintaining a means external to our site for any reconstruction of any lost data.

8.3 We, as Provider, will not be liable for any loss or damage caused by any distributed denial-of-service attack, viruses or other technologically harmful material that may infect your computer equipment, software, programs, data or other proprietary material due to your use of the Website or items obtained or downloaded through the Website.

8.4 MicroPort hereby disclaims all warranties of any kind, whether express or implied, statutory or otherwise, including but not limited to any warranties of merchantability, non-infringement, and fitness for particular purpose.

9. Applicable Law and Jurisdiction

Any disputes to which these Terms of Use may give rise to as a result of the execution, interpretation, validity, performance or termination of these Terms of Use, shall be governed exclusively by French law. All disputes shall be submitted exclusively to the sole jurisdiction of the competent court in Paris, France.

10. Intellectual Property Rights

The Website and its entire contents, features and functionality (including but not limited to all information, software, text, displays, images, video, and audio, and the design, selection, and arrangement thereof), are owned by MicroPort, its licensors, or other providers of such material and are protected by French, European Union and international copyright, trademark, patent, trade secret, and other intellectual property or proprietary rights laws. You are obligated to observe and not infringe these intellectual properties or proprietary rights.

11. Changes to the Terms of Use

The Provider reserves the right to revise and update these Terms of Use from time to time at its sole discretion. Such reasons may include, but are not limited to, the following: compliance with legal or regulatory circumstances, technical or security improvements, changes in market conditions, or further developments of the Service. All changes are effective immediately once published online, and shall apply to the access and use of the Website thereafter. Customers will be able to read and accept any changes to the Terms of Use online. By accepting the changes, Customers consent to the continued use of the Website and its associated services.

12. Your Visits to the Website

All information we collect on this Website is subject to our Privacy Policy. By using the Website or clicking “I Accept” when prompted, you explicitly consent to all actions taken by us with respect to your information in compliance with the Terms of Use and our Privacy Policy.

13. Entire Agreement

The Terms of Use and our Privacy Policy constitute the sole and entire agreement between you and MicroPort with respect to the Website and supersede all prior and contemporaneous understandings, agreements, representations, and warranties, both written and oral, with respect to the Website.

14. Contact Us

This Website is operated by MicroPort CRM.

All other feedback, comments, requests for technical support and other communications relating to the Website should be directed to MicroPort Customer Service (See Contact Us information on SmartView Website Login page), or to: https://microport.com/about-us/contact-us.

Version: N° 1 - 2023 – EN – Last update JULY 2023