TERMS AND CONDITIONS

PREAMBLE

The purpose of these General Terms and Conditions of Sale is to govern the contractual relationship between you (hereinafter the 'Customer') and BIOTECH DENTAL SMILERS, a simplified joint stock company with capital of €125,000.00, whose registered office is located at 305 Allées de Craponne – 13300 Salon de Provence, registered with the Trade and Companies Register of Salon-de-Provence under number 801 674 375, whose EU VAT number is FR 93 80 167 4375, whose contact e-mail address is:

  • for the product FROGGYMOUTH: contact@froggymouth.com

  • for the product MYOSIMPLE: contact@myosimple.com

The Company markets medical devices intended, in particular, for dentists, orthodontists, paramedical professionals, etc.

The Company will supply the goods to the Customer in accordance with the terms and conditions set out below. The Customer declares that they are aware of and accept the terms and conditions of sale.

The Customer assumes full responsibility for the use made of the Product, whether used separately or in conjunction with other equipment not manufactured by the Company.

The Company strongly recommends that Product users follow the appropriate protocol.

All other terms and conditions are excluded and are not applicable without the Company's prior written consent.

Placing an order implies unreserved acceptance of these terms and conditions.

Consequently, the Customer is deemed to have accepted all the provisions of these terms and conditions without reservations.

Article 1: PURPOSE

1.1. The Products marketed under these General T&Cs are functional orthodontic devices intended to restore a functional balance.

1.2. The general terms and conditions of sale described below detail the rights and obligations of the Company and the Customer in the context of the distance selling of the goods described below, which can be ordered from the website accessible at the following address:

  • For the product FROGGYMOUTH: www.froggymouth.com

  • For the product MYOSIMPLE: www.myosimple.com

(Hereinafter referred to as "the Website(s)")

1.3. The goods sold by the Company are mainly intended for professionals deemed to be acting in the course of their professional activity: Customers cannot therefore invoke the provisions of the French Consumer Code, such as the right of withdrawal. Where individuals place an order for the Product for their personal use, the French Consumer Code then applies.

1.4. The T&Cs apply regardless of any clauses contained in the Customer's documents, including their general terms and conditions of purchase.

1.5. Distribution products may be subject to specific terms and conditions of sale imposed by the supplier. On request, the Company will make the supplier's terms and conditions available to the Customer before the contract is signed.

Article 2: CONTRACTUAL SCOPE

2.1. These T&Cs, together with any special terms and conditions of sale and/or the quote or purchase order, express the entire agreement between the parties. The latter will therefore not be able to rely on any other document, contract or exchange that precedes the confirmation of the purchase order.

2.2. Where they exist for certain products, the special terms and conditions of sale specify or supplement these T&Cs. In the event of any contradiction between the special terms and conditions of sale and these T&Cs, the provisions of the special terms and conditions of sale shall prevail.

2.3. In the event that any of the provisions of these T&Cs are declared null and void or unwritten by a competent court, the other provisions will remain in full force and will be interpreted in such a way as to respect the parties' original intention.

2.4. The Company may amend these T&Cs at any time. The applicable T&Cs are those that can be consulted online on the Websites. The Customer acknowledges and accepts them, without reservations, simply by placing an order.

Article 3: COMMERCIAL DOCUMENTS AND SCOPE OF THE OFFER

3.1. Access to the Website is provided on a permanent basis, subject however to periods of maintenance and upkeep of the Website, server update operations and any one-off interruptions.

3.2. The brochures and other commercial documents published by the Company present the Company's range of goods. The Company reserves the right, with or without prior notice, to limit the quantity available or to discontinue the sale of any product.

3.3. The photographs, visuals and descriptions presented in these commercial documents published on the Website or distributed are not contractual.

Article 4: ORDERS

4.1. All orders must be made exclusively via the Website or via the LaGalaxy platform.

4.2. Contractual information is provided in French.

4.3. When placing an order, the Customer must provide the Company with the information required for the transaction within the specified time (bank details, invoicing address, etc.). The Company accepts no liability for any errors in entering this information. Contractual information will be monitored on the interface dashboard by the Company. Incomplete or incorrect applications will be rejected.

4.4. The Customer places an order on the Website after having read and accepted these general terms and conditions of sale and any special terms and conditions of sale applicable to certain products. They are then automatically directed to the payment platform. The Customer's double 'click' on the purchase order constitutes an electronic signature that is equivalent to a handwritten signature between the parties.

4.5. Orders placed on the Website are subject to confirmation from the Company.

4.6. As soon as the order has been confirmed, an invoice will be posted online on the customer's account on the Website or sent to the lending agency/hire company.

4.7. Any order approved and recorded by the Company may not be cancelled and must be subject to receipt of the goods and full payment for these goods.

4.8. The Company reserves the right to suspend any order from a Customer in respect of whom there is a dispute relating to the payment of a previous order.

4.9. In order to protect all of the Customer's personal data, it will only be accessible via secure access (login and password). The Customer authorises the Company to use this data in a protected framework.

Article 5: OBLIGATIONS OF THE PARTIES

5.1. The Company's obligations

In accordance with the legal provisions, the Company undertakes to deliver goods that conform to the contract and is liable for any compliance defects that exist at the time of delivery. The Company also guarantees the Customer against hidden defects in the item sold, under the conditions of articles 1641 et seq. of the French Civil Code.

5.2. The Customer's obligations

5.2.1. The Customer undertakes to pay the price and to comply with the payment terms and dates set out in the special terms and conditions of sale and/or the quote or purchase order.

5.2.2. The Customer undertakes to provide all the information required for the transaction and delivery (name, address, etc.). Failing this, the Company is not obliged to confirm the order. The Company accepts no liability for any errors in entering this information. Where the inadequacy or erroneous nature of the information provided by the Customer makes it impossible to deliver the goods, the Customer may not claim any reimbursement. In addition, the Customer undertakes to inform the Company immediately of any change in legal form of the business, delivery or invoicing address, bank details, telephone number or any other change affecting the contractual relationship (SIRET number, e-mail address, etc.).

Article 6: DELIVERY, RIGHT OF WITHDRAWAL AND RETURN OF GOODS

6.1. Delivery

Delivery is possible in mainland France. Delivery to French overseas departments and territories and abroad is possible under certain conditions. Delivery is made to the location indicated by the Customer on the form. The delivery time indicated when the order is placed is given as an indication only and is not guaranteed. Under no circumstances shall the estimated date and time of delivery become an essential condition of the Contract. Consequently, any reasonable delay in the delivery of the products shall not give rise to the allocation of damages and interests in the Customer's favour, the cancellation of the order and/or the refusal of goods. If delivery is refused without a legitimate reason, the Customer must pay all costs or losses incurred by the Company as a result of this refusal, including storage costs, until delivery is accepted. Deliveries are charged according to the current pricing conditions.

6.2. Right of withdrawal

When the Customer purchases goods sold by the Company outside the scope of their professional activity, they benefit from a right of withdrawal. In accordance with the applicable legal provisions, the Customer may exercise their right of withdrawal once their order has been confirmed and up to fourteen (14) days after the delivery of the product without having to provide reasons or pay penalties. To comply with the withdrawal period, the Customer must send their communication regarding the exercise of the right of withdrawal before the withdrawal period expires. In the event of exercising the right of withdrawal within the aforementioned period, only the price of the product or products purchased and shipping costs on a maximum flat-rate basis will be refunded to the customer. The Company will inform the Customer by email or telephone of the methods for sending or collecting the product. If the product must be returned by the Customer, the latter must return the product at their own expense without undue delay and, in any case, at the latest fourteen (14) days after the Customer has communicated their decision to withdraw from this contract. This period is deemed to have been met if the Customer returns the product before the expiry of the fourteen (14) day period. The Customer must comply with the return procedures defined below. The Customer will refund the full amount no later than fourteen (14) days from the date the Company is informed of the Customer's decision to exercise their right of withdrawal. The refund will be made when the Company has received the goods subject to the exercise of the right of withdrawal and inspection of their condition.

6.3. Returns

Any return request must be made by email. Except in cases where the right of withdrawal is exercised under the conditions defined above, returns are possible within 30 days following the delivery of the order by the Company. To be accepted, products must still be in the standard catalogue at the time of return, be in their original packaging, be recognised by the Company as in good condition (undamaged, without nicks or scratches) and be accompanied by a copy of the original invoice or delivery note. Returns made under the conditions defined in this article will be subject to a credit note. Return costs may be charged. Products that are no longer manufactured or have been specially modified or adapted cannot be returned.

Article 7: RETENTION OF TITLE CLAUSE

Goods unpaid on the due date (or their resale price if they have been resold by the Customer) may be taken back or reclaimed by the Company as compensation for any unpaid invoices, without prejudice to the Company's right to terminate current orders. During the period of retention of title, the risks having been transferred to the Customer as soon as the goods leave the Company's warehouses, the Customer must insure the goods against all risks of damage. If the Customer is the subject of receivership or liquidation proceedings, the Company reserves the right to reclaim, within the framework of the receivership proceedings, the goods sold and remaining unpaid.

Article 8: PRICE

The prices of the goods sold are those in force on the date the order is placed. All prices are given in euros and do not include Value Added Tax, which will be invoiced in addition at the rate in force at the time the order is placed. Transport costs will also be added to the price. The Company reserves the right to modify its prices at any time, and in particular to adapt them in the event of changes in exchange rates, tax rates, insurance premiums, freight costs and the purchase price of raw materials.

Article 9: PAYMENT TERMS

For any order placed on the Websites, payment is made by credit card at the time of the order. For orders placed by email or telephone, payment by cheque or bank transfer within 30 days end of month from the date of invoice issuance is possible. In accordance with the provisions of Article L 441-10 of the French Commercial Code, any amount unpaid at its due date shall automatically bear late payment interest equal to the European Central Bank's interest rate applied to its most recent refinancing operation, increased by 10%, without being less than three times the legal interest rate, without prejudice to any other compensation that the Company reserves the right to claim. Fixed compensation of €40 will be payable to the Company for any payment made after the due date in accordance with Law no. 2012-387 of 22 March 2012, without prejudice to the right to claim additional compensation if the recovery costs incurred by the Company exceed this amount (including legal costs). Late payment is defined as payment made after the date stated on the invoice. The Company reserves the right to suspend any order from a Customer in respect of whom there is a dispute relating to the payment of a previous order.

Article 10: CLAIMS

Goods sent carriage paid or carriage forward travel at the recipient's risk, and any reservations must be stated to the carrier on receipt. Any claim for incomplete delivery must be made within 7 days of receipt of the goods. Any claim concerning damaged goods must be made within 7 days of receipt of the goods and must be accompanied by a detailed report to the Company's insurance company or the carrier. Any claim not accompanied by a report will not be accepted. The Company provides its Customers with an after-sales service that can be contacted by telephone or e-mail. The contact is the sales administration department, which will assist the Customer in contacting the Company's experts depending on the type of request.

Article 11: WARRANTY

Standard products are guaranteed for a period of 12 months from the date of delivery by the Company against any manufacturing defects. By way of exception, when the product is acquired by an individual, this period is extended to 24 months under the same conditions. Distribution products may be subject to specific warranty conditions imposed by the supplier. On request, the Company will make the supplier's specific warranty conditions available to the Customer before the contract is signed. The Company reserves the right to repair or replace any products under its warranty conditions. The Company accepts no liability for products returned without prior authorisation. The Customer assumes full responsibility for the use it makes of the Products, whether it uses them separately or in conjunction with other equipment manufactured or not and/or distributed or not by the Company. The Company may not be held liable for direct or indirect consequences:

  • Of the misuse of the products sold by the company, whether on people or property,

  • Of the use of the Products in breach of the protocol described in the instructions for use.

The Company does not guarantee the suitability of the Products for a given use, nor the performance or other specifications not explicitly specified in the Contract. Also excluded from any warranty are normal wear and tear of the Products, any consequence of negligence, lack of supervision or maintenance, incorrect operation not attributable to the Company, use not in accordance with the specifications or a modification carried out without the Company's written consent.

Article 12: LIABILITY

The Company disclaims all liability, express or implied, and shall not be held liable for any direct or indirect damage resulting from or in connection with any error of judgement or professional practice in the use of the products. No product or information disseminated by the Company is a substitute for the services of experienced healthcare professionals, nor for medical advice from a practitioner. The Company offers no assurance or guarantee for its Products concerning the treatment, action or medication. The Company strongly recommends that users of its Products have the appropriate training to use them. The Customer assumes all risks and responsibilities arising from the use of these Products, either separately or in conjunction with other products. The Company may not be held liable, on any grounds whatsoever, for any direct or indirect material, intangible or physical damage caused to the Customer, of any nature whatsoever, resulting from the non-compliant use or handling of the Products which are the subject hereof. In any event, the Company's liability shall be expressly limited to the price paid by the Customer for the products that are the subject of the dispute.

Article 13: MEDICAL DEVICE VIGILANCE AND PRODUCT TRACEABILITY

In accordance with their legal obligations, the Customer undertakes to notify the Company or the competent national authority of any case of medical device vigilance brought to its attention and to guarantee the traceability of the products delivered to them by the Company.

Article 14: INTELLECTUAL PROPERTY

The BIOTECH DENTAL Group, to which the Company belongs, is the owner of its registered trademarks, which may not be reused without its prior consent. The Websites are governed by French and international legislation on copyright and intellectual property. All reproduction rights are reserved, including for downloadable documents and iconographic and photographic representations. The visuals used to illustrate the website are the Company's property. The rights of use, reproduction and distribution are strictly reserved by the Company. The reproduction, re-use and extraction of all or part of the structure and/or content of its website on any medium whatsoever is strictly prohibited without the Company's express authorisation.

Article 15: PERSONAL DATA

The Company is the data controller of the Customer's personal data. The Customer's personal data collected and stored by the Company as part of any order is used solely for the purpose of managing orders, deliveries and invoices. The information requested from the Customer is necessary to process their order. It is intended for the data controller and its authorised personnel. It may also be disclosed to the Company's contractual partners involved in fulfilling the order. Data is kept for as long as is necessary for the purposes for which it is to be processed. Personal data collected on the Website is archived for 5 years after the last use of the Website. It is kept for the duration of the contractual relationship plus 3 years for marketing and prospecting purposes, without prejudice to retention obligations or limitation periods. In accounting terms, it is kept for 10 years from the end of the financial year. The Company reserves the right to use the personal data transmitted by the Customer for commercial purposes.

Under Articles 15 to 22 of the General Data Protection Regulation of 27 April 2016, subject to meeting the conditions set out in those articles, individuals whose data is processed have the option:

  • to access all of their personal data,

  • to rectify inaccurate and/or incomplete data,

  • to obtain the deletion of their data.

Subject to providing proof of their identity, and where technically possible, Customers may request the portability of the personal data they have provided. Customers may also request that processing be limited, and may object at any time to the processing of their data for reasons relating to their personal situation. However, the data controller may refuse to grant the request if they can demonstrate legitimate and overriding reasons that prevail over the interests and rights and freedoms of the Customer or for the establishment, exercise or defence of their rights in court. The data controller indicates that this right to object may also be exercised by the Customer when the data is only processed for prospecting purposes. Furthermore, where the sole legal basis for processing is the consent given by the Customer, the latter may withdraw this consent at any time.

In order to exercise their rights, Customers must contact the data controller, attaching proof of identity to their request and indicating their e-mail address. The data controller shall provide enhanced security for the collection and processing of data by taking all necessary and reasonable measures to ensure the security and protection of data. In the event of a complaint concerning the processing of Data, the Customer may contact the data controller using the details given in the contact section of the website. The data controller must do their utmost to propose a reasonable solution. If there is no response from the data controller, or if the dispute persists despite the proposal made, the Customer may lodge a complaint with the French Data Protection Authority (Commission Nationale de l'Informatique et des Libertés).

Article 16: PROCESSING OF PERSONAL DATA

In the context of their contractual relationship, the parties undertake to comply with the regulations in force applicable to the processing of personal data and, in particular, Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 (hereinafter, 'the European General Data Protection Regulation' or GDPR), Law no. 78-17 of 6 January 1978 on data protection, as well as the provisions of the French Public Health Code.

16.1. Description of the data processing

In its capacity as processor, the Company is authorised to process personal data on behalf of the Customer, the data controller, in order to sell them the products they order. The Company will use the personal data provided by the Customer to manufacture the product ordered. The purpose of the processing is to fulfil the Customer's order placed with the Company. The personal data processed relates to the Customer's Customer (the End Customer). This data is as follows: Patient name, File number, Health data (after-sales).

16.2. The Company's obligations towards the Customer

The Company undertakes to:

  • 1. Process data solely for the purpose intended,

  • 2. Process data in accordance with the data controller's documented instructions set out in this contract.

If the processor considers that an instruction constitutes a breach of the European General Data Protection Regulation or of any other provision of Union or Member State law relating to data protection, it shall immediately inform the data controller. In addition, if the processor is obliged to transfer data to a third country or to an international organisation, by virtue of Union law or the law of the Member State to which it is subject, it must inform the data controller of this legal obligation prior to processing, unless the law concerned prohibits such information on important public interest grounds,

  • 3. Guarantee the confidentiality of personal data processed under this contract,

  • 4. Ensure that persons authorised to process personal data under this contract:

  • Undertake to observe confidentiality or are subject to an appropriate legal obligation of confidentiality,

  • Receive the necessary training in the protection of personal data,

  • 5. Take into account the principles of data protection by design and data protection by default for its tools, products, applications and services.

16.3. Sub-processing

In its capacity as processor, the Company may call upon another processor (hereinafter referred to as 'the sub-processor') to carry out specific processing activities. The processor is authorised to call on sub-processing entities (hereinafter, the 'sub-processor') to carry out certain processing activities. The sub-processor is required to comply with the obligations of this contract on behalf of and in accordance with the instructions of the data controller. It is the responsibility of the original processor to ensure that the sub-processor presents the same sufficient guarantees regarding the implementation of appropriate technical and organisational measures so that the processing meets the requirements of the European General Data Protection Regulation. If the sub-processor does not fulfil its data protection obligations, the original processor remains fully liable to the data controller for the sub-processor's fulfilment of its obligations.

16.4. Right to information for data subjects

It is the responsibility of the Customer, the data controller, to provide information to the data subjects of the processing operations at the time the data is collected.

16.5. Exercising individual rights

As far as possible, in its capacity as processor, the Company must help the Customer, the data controller, to fulfil their obligation to comply with requests to exercise the rights of data subjects: right to access, rectify, erase, object, limit processing and data portability and right not to be subject to an automated individual decision (including profiling). When data subjects make requests to the Company to exercise their rights, the Company must send these requests to the Customer by e-mail as soon as they are received.

16.6. Notification of personal data breaches

The Company will notify the Customer of any breach of personal data within a maximum of 48 hours of becoming aware of it by e-mail or telephone. This notification shall be accompanied by any useful documentation to enable the Customer, the data controller, if necessary, to notify this breach to the competent supervisory authority. The notification shall contain:

  • (a) A description of the nature of the personal data breach including, if possible, the categories and approximate number of persons affected by the breach and the categories and approximate number of personal data records affected;

  • (b) The name and contact details of the data protection officer or other contact point from whom further information can be obtained;

  • (c) A description of the likely consequences of the personal data breach;

  • (d) A description of the measures taken or proposed to be taken by the data controller to remedy the personal data breach, including, where appropriate, measures to mitigate any negative consequences.

16.7. Processor assistance

In its capacity as processor, the Company shall assist the data controller in carrying out data protection impact assessments. The processor shall assist the data controller in carrying out a prior consultation with the supervisory authority.

16.8. Security measures

In its capacity as processor, the Company agrees to implement the following security measures:

  • Pseudonymisation and encryption of personal data;

  • Means of guaranteeing the ongoing confidentiality, integrity, availability and resilience of processing systems and services;

  • The means of restoring the availability of personal data and access to it within an appropriate time frame in the event of a physical or technical incident;

  • A procedure for regularly testing, analysing and assessing the effectiveness of technical and organisational measures to ensure the security of processing.

The Company undertakes to implement the security measures provided for in the reference frameworks or codes of conduct to which it is bound, where applicable, or the certification or approval it may hold.

16.9. What happens to the data

At the end of the main processing contract, the Company undertakes to:

  • Return all personal data to the Customer, the data controller, where applicable,

  • Return the personal data to the processor appointed by the data controller.

Returns must be accompanied by the destruction of all existing copies in the processor's information systems. Once destroyed, the Company must provide proof of the destruction in writing.

16.10. Data protection officer

The Company shall inform the Customer of the name and contact details of its data protection officer: Aurélia DUBOIS

  • Postal address: 305 allées de Craponne 13300 Salon-de-Provence, France,

  • Email address: dpo.bd@biotech-dental.com

16.11. Register of categories of processing activities

The Company declares that it keeps a written record of all categories of processing activities carried out on behalf of the Customer, the data controller, including:

  • The name and contact details of the data controller on whose behalf it is acting, of any data processors and, where applicable, of the data protection officer;

  • Categories of processing carried out on behalf of the data controller;

  • Where applicable, transfers of personal data to a third country or to an international organisation, including the identification of that third country or international organisation and, in the case of transfers referred to in the second subparagraph of Article 49(1) of the European Data Protection Regulation, documents attesting to the existence of appropriate safeguards;

  • As far as possible, a general description of the technical and organisational security measures, including, as appropriate: Pseudonymisation and encryption of personal data; Means to guarantee the ongoing confidentiality, integrity, availability and resilience of processing systems and services; Means to restore availability of and access to personal data within an appropriate time frame in the event of a physical or technical incident; A procedure for regularly testing, analysing and assessing the effectiveness of technical and organisational measures to ensure the security of processing.

16.12. Documentation

The Company shall make available to the data controller the documentation necessary to demonstrate compliance with all its obligations and to enable audits, including inspections, to be carried out by the Customer, the data controller, or another auditor appointed it has appointed, and to contribute to such audits.

Article 17: CUSTOMER OBLIGATIONS (PERSONAL DATA)

The Customer undertakes to:

  • 1. Provide the aforementioned data to the processor,

  • 2. Document in writing any instructions concerning the processing of data by the Company,

  • 3. Ensure, beforehand and throughout the processing activity, that the processor complies with the obligations set out in the European General Data Protection Regulation,

  • 4. Supervise the processing, including carrying out audits and inspections of the Company.

Article 18: TERMINATION

If, within 15 days of the implementation of the stipulations relating to late payment, the Customer has not paid the remaining sums due, the sale will be cancelled ipso jure and may give rise to a claim for damages and interests in the Company's favour.

Article 19: ASSIGNMENT – SUBCONTRACTING

The Customer may not transfer all or part of its rights and obligations under the Contract without the Company's prior written consent. The Company reserves the right to assign, transfer or contribute to a third party, in any form whatsoever, the rights and obligations arising from the Contract, provided that this third party replaces the Company in their performance, and the aforementioned provisions relating to the processing of personal data.

Article 20: FORCE MAJEURE

The Company may not be held liable if the non-performance or delay in the performance of any of its obligations described in these general terms and conditions of sale is due to a case of force majeure, within the meaning of applicable legislation.

Article 21: APPLICABLE LAW

All disputes relating to the sale of goods concluded by the Company and to the application or interpretation of these general terms and conditions of sale shall be governed by French law. Any disputes will be subject to prior consultation in order to find an amicable solution, failing which the most diligent party will refer the matter to the competent court.

Article 22: JURISDICTION

Failing an amicable resolution, the dispute will be brought before the courts within the Company's jurisdiction, and in particular before the Commercial Court of Salon-de-Provence.

Salon de Provence, 15 September 2025

BIOTECH DENTAL SMILERS FROGGYMOUTH & MYOSIMPLE – T&Cs September 2025