Privacy Notice

This privacy policy applies to the personal data we process in the context of the proposed study. At Ad Scientiam, we respect your privacy and would like to inform you about the processing of your personal data while allowing you to exercise your rights. The purpose of this privacy policy is to inform you concerning the personal data we collect, the purposes for which we process it, how long we keep it and your privacy rights.

Participation in this research is voluntary. You may refuse to participate or stop participating at any time. Your decision will not result in any penalty or loss of services to which you are entitled.

If you have any questions, concerns or complaints, or if you feel that you have been adversely affected by this research, please contact the research team at the telephone number(s) listed in this document.

The aim of this study is to validate the performance and safety of the mobile application for measuring symptoms at home as compared with assessments carried out in a hospital with a doctor in order to improve and standardize remote monitoring of multiple sclerosis patients and accurately assess disease progression. The study will also evaluate how easy the tool is to use, as well as your satisfaction with the mobile application.

Processing of your personal data is governed by the General Data Protection Regulation (EU) 2016/679 ("GDPR") and by the laws applicable in your country of residence. The GDPR requires defining the role and responsibilities of each party in the processing of your personal data.

The sponsor will work with Sanofi ("Sanofi") to support the study. As such, Sanofi and the sponsor are jointly responsible for processing your personal data ("joint controller(s)"). If you agree to participate in this study, certain personal information about you will be collected, stored, processed and used by:

• Ad Scientiam, Sponsor of the clinical study, acting as “Data Controller” and located in France.
• Sanofi, its affiliates or other third parties designated by Sanofi, acting as "joint controllers" and located in the United States.
• PopsiCube, its partners and affiliates, a clinical research organization in charge of organizing the clinical study, acting as a "subcontractor" and located in the European Union.
• Service providers who providing services related to the organization of clinical studies, data hosting and remuneration of participants, acting as "subcontractor(s)" located in the European Union and the United States.
• The investigators who investigate centers and personnel involved in conducting the study, acting as "subcontractor(s)" and located in the European Union, Canada and the United States.
• The personal protection/ethics committee overseeing the research study at your center.
• Government regulatory agencies including the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), the Therapeutic Goods Administration (TGA), Health Canada and other regulatory authorities worldwide.

The legal basis chosen by data controllers is the pursuit of legitimate interests (Article 6 f. of the GDPR). Study data, including your coded medical information, may be processed as personal data within the definition stated in the GDPR. This means that your information will be collected, entered into computer databases, stored, consulted, checked, analyzed, transferred and printed for scientific research purposes. These purposes may include use in future medical or pharmaceutical research. In this case, you will be informed in accordance with the applicable regulations. Data controllers must implement appropriate measures to guarantee your rights and freedoms, including only collecting data that is strictly necessary for research purposes. If you have any questions about the legal basis for the processing of your personal data, please contact the investigator who proposed your participation in this study. In order to preserve your confidentiality with respect to the sponsor, all comments, communications and complaints addressed to the sponsor's data protection officer (privacy@adscientiam.com) must first be sent to the investigator, wherever possible.

Where applicable, data transfers are carried out pursuant to a European Commission adequacy decision (Article 45 of the GDPR) or appropriate safeguards such as contractual clauses between data controllers and/or subcontractors (Article 46 of the GDPR). If you participate in this study, your personal data will be transferred to the European Union, Canada and the United States. For more information on the transfer of your personal data, please contact the investigator who proposed your participation in this study. In order to preserve your confidentiality with respect to the sponsor, all comments, communications and complaints addressed to the sponsor's data protection officer (privacy@adscientiam.com) must first be sent to the investigator, wherever possible.

The following data will be collected:

• Social data: month and year of birth, gender, country, family situation, level of education, socio-professional category, your caregivers, working life, social security affiliation.
• MSCopilot® Detect digital test and questionnaire metadata: start date, end of test or questionnaire, reason for stopping, etc.
• Data related to the research process: date of visit, participation in other ongoing studies, travel to the care facility, living habits, reimbursement of expenses incurred by the person concerned in connection with the research, annual amount of compensation received.

To compensate you for your participation, the following data will be collected:

• First and last name, date of birth, email address, billing address, delivery address (credit card delivery, if applicable), cell phone number, IP address, IBAN (optional, if applicable), clinical study identification number, follow-up on your participation in clinical studies, follow-up on the completion of visits, expenses to be reimbursed with supporting documents.

To obtain more information about the personal data collected, please contact the investigator who proposed your participation in this study. In order to preserve your confidentiality with respect to the sponsor, comments, communications and complaints addressed to the sponsor's data protection officer (privacy@adscientiam.com) must first be sent to the investigator, wherever possible.

Personal information collected as part of this study will be retained for up to two (2) years after publication of the final study report, unless legal retention requirements force data controllers and/or their subcontractors to retain data for a longer period.

After this two-year period, your personal data will be archived by the sponsor and/or data controllers for twenty-five (25) years after the end of the study, in accordance with applicable regulations.

Your personal data will be archived by the investigators, investigating centers and staff for fifteen (15) years after the end of the study, in accordance with applicable regulations.

After this period, your personal data will be deleted or made anonymous, which means that it may be used in a non-identifiable way for statistical analysis and business planning purposes.

Research results may be presented at scientific meetings or in publications, but your identity will not be divulged.

You will be providing personal information as part of your participation in this study, which involves a slight risk of loss of confidentiality. Every effort will be made to protect this information from disclosure. However, the U.S. Food and Drug Administration and other regulatory agencies may inspect study files. During the initial session, you will be assigned a unique participant number that will be used throughout the study. Your personal identity will not be revealed in any publications that may result from this study. Your name will also not be used in other research-related communications, such as lectures at scientific meetings. Experimental data and personal information will be retained by the investigators and will not be disclosed in a manner that would allow you to be personally identified. Only summary statistics such as your age and gender will be included in published experimental results. The consent form you signed before the start of the clinical study, as well as any form containing your personal details, will be kept in a place accessible only to the center's investigator or the person designated by them.

A description of this clinical trial will be available at http://www.ClinicalTrials.gov, as required by U.S. law. This website will not contain any personally identifiable information. At most, it will include a summary of the results. You can search this site at any time.

Your participation in this study is entirely voluntary. You may refuse to participate or stop participating at any time. Refusal to participate or withdrawal from the study will not result in any penalty or loss of benefits to which you are entitled. If you change your mind, you are free to end the session and withdraw from the study. Your decision whether or not to participate in this study will not affect the quality of medical care you receive at this facility. You have as much time as you need to decide whether or not to take part in this study.

our decision will not prejudice the processing of your personal data. You may withdraw your consent to the processing of your personal data at any time, without having to justify your decision and without any consequences. If you choose not to consent or to withdraw your consent for the collection, access, use, storage, disclosure and transfer of your data, you will not be able to participate in the study, as your data is necessary to carry out the study. If you revoke your consent, your participation in the study will be terminated at the end of the early termination visit(s) and the study staff will not collect any new medical information from you.

You have the right to access your personal data, the right to rectify inaccurate data, the right to be forgotten (which allows you to request the deletion of your personal data), the right to restrict the processing of your data and the right to object, at any time, to the processing of your personal data, as permitted by the data protection laws applicable in your country and the laws relating to the conduct of clinical trials.

To exercise these rights or if you have any questions about the processing of your data, you can contact the investigator at the number(s) indicated at the beginning of this document. In order to preserve your confidentiality with respect to the sponsor, comments, communications and complaints addressed to the sponsor's data protection officer (privacy@adscientiam.com) must first be sent to the investigator, wherever possible.

In accordance with Article 77 of the GDPR, if you feel, after contacting us, that your rights have not been respected, you have the right to lodge a complaint with the privacy or data protection authority in your country of residence. If you are a French resident, you can contact the Commission nationale de l'information et des libertés (www.cnil.fr/en/home).