Legal notice.

01Publisher

Company name

Boli Care SAS

Legal form

Société par Actions Simplifiée (SAS)

Registered office

3 rue Loustau, 64200 Biarritz, France

RCS

989 985 718 R.C.S. Bayonne

SIRET

989 985 718 00018

VAT number

FR11989985718

Email

contact@boli.care

Publication director

Paul-Louis Belletante

Hosting

This website is hosted by OVH SAS (OVHcloud), 2 rue Kellermann, 59100 Roubaix, France - ovhcloud.com.

Website hosting is provided through OVHcloud infrastructure located in France / the European Union. Health data processed by the Boli Care medical device are hosted on OVHcloud’s certified HDS (Hébergement de Données de Santé) infrastructure, in compliance with the GDPR and Article L.1111-8 of the French Public Health Code.

Design and development: in-house team - Boli.

02Intellectual property

The entire website (structure, design, text, images, logos, videos, databases, etc.) is the exclusive property of Boli, unless otherwise indicated, and is protected by French and international intellectual property law (notably articles L.111-1 et seq. of the French Intellectual Property Code).

Any reproduction, representation, modification, publication or adaptation of all or part of the website's elements, by any means or process, is prohibited without the prior written authorisation of Boli.

03Purpose of the site

The website boli.care provides information about the mission, services and future offerings of Boli, a digital therapeutic solution designed to support people treated with anti-obesity medications and to durably improve their metabolic health.

04Medical device status

Boli Care is a Class I software medical device under Regulation (EU) 2017/745 (MDR) on medical devices. As such, it is a regulated health product which bears the CE marking.

Intended purpose. Boli Care is a digital medical device intended for adult patients (≥ 18 years) on pharmacological treatment for obesity and its metabolic comorbidities (notably type 2 diabetes, dyslipidemia, hypertension, metabolic dysfunction-associated steatotic liver disease [MASLD/MASH], obstructive sleep apnea syndrome), designed to support treatment adherence, persistence and understanding, as a complement to the medical follow-up provided by healthcare professionals.

Limitations of use. Boli Care does not provide a diagnosis, does not recommend treatment modifications and does not generate automated clinical alerts. It is not a substitute for medical consultation or for the clinical judgement of the healthcare professional.

Manufacturer

Boli Care SAS - 3 rue Loustau, 64200 Biarritz, France

SRN (EUDAMED)

FR-MF-000053003

UDI-DI

(01) 03770042909124

Instructions for Use (eIFU)

manual.boli.care

Quality management system

ISO 13485-aligned

Vigilance. Any serious incident or risk of serious incident must be reported to the manufacturer at vigilance@boli.care and to the French ANSM via signalement.social-sante.gouv.fr, or to the competent authority of the Member State in which the user and/or patient is established.

05Liability

Boli endeavours to ensure the accuracy and relevance of the information published on the site. However, it cannot guarantee the absence of errors, omissions or outdated information. The user acknowledges that they use this information under their sole and full responsibility.

Boli cannot be held liable for direct or indirect damages arising from access to or use of the site, including unavailability, loss of data or damages resulting from computer viruses.

06Hyperlinks

The site may contain hyperlinks to third-party websites. Boli has no control over these sites and disclaims all liability for their content, availability or data-protection practices.

07Accessibility

Boli is committed to making this website accessible to the widest possible audience, in line with the Référentiel Général d'Amélioration de l'Accessibilité (RGAA) in France and the European Accessibility Act (Directive (EU) 2019/882). An accessibility audit and statement will be published as the website matures.

If you encounter an accessibility barrier, please write to hello@boli.care with a description of the issue and the URL - we will reply within a reasonable time and provide an alternative if needed.

08Personal data

The site may collect personal data in accordance with our Privacy Policy. In accordance with Regulation (EU) 2016/679 (GDPR) and amended French Law n° 78-17 of 6 January 1978 (Loi Informatique et Libertés), users have rights over their personal data.

To learn more or to exercise your rights, see our Privacy Policy or contact us at privacy@boli.care.

09Cookies

The site uses cookies and other tracers to improve the user experience and for audience-measurement purposes. In accordance with the CNIL recommendations, no non-essential cookie is set without your prior consent. For more information or to set your preferences, see our Cookie Policy.

10Reporting illegal content

Under article 6 of the LCEN and Regulation (EU) 2022/2065 (Digital Services Act), you can report content you consider illegal by writing to legal@boli.care, indicating:

• The precise URL or location of the content;
• A reasoned explanation of why the content is allegedly illegal;
• Your name and email (except for child sexual abuse material);
• A statement of good faith.

We will acknowledge receipt without undue delay and inform you of our decision and possibilities of redress.

11Applicable law & jurisdiction

This site and its legal notice are governed by French law. Any dispute will fall within the exclusive jurisdiction of the competent courts of Bayonne, subject to mandatory legal provisions to the contrary, including consumer-protection rules that allow consumers to bring an action before the courts of their place of residence.