general terms and 
CONDITIONS OF SALE

preamble

ORTHOPUS is a simplified joint-stock company (SAS) with a social impact, whose registered office is located at 6, rue Saint Domingue, 44200 Nantes (France), registered with the Trade and Companies Register under SIREN number 843 788 811, founded in Nantes (France) in November 2018, which develops and markets innovative robotic assistants for arm mobility and their peripherals.

ORTHOPUS’ ambition is to promote access to assistance technologies by equipping as many people as possible awaiting a solution, and to participate in the evolution of the medical sector towards inclusive and open health.

Since 2019, ORTHOPUS has been a Socially Responsible Company making a contribution to society, holding “ESUS” authorisation.

ORTHOPUS tends to market its products to specialised distributors of medical equipment, healthcare establishments, associations working in the field of disability, in connection with patients and users, and to companies acting in the context of actions to prevent musculoskeletal disorders (MSDs).

SCOPE OF APPLICATION

These General Terms and Conditions of Sale (GT&Cs) apply to the robotic assistance products and their accessories (hereinafter, the “Products”) sold by ORTHOPUS.

The GT&Cs can be consulted on the Orthopus website in French orthopus.com/fr/conditions-generales-de-vente/ and in English https://orthopus.com/en/conditions-of-sale/

The sale of the Products is reserved for specialised distributors of medical equipment, healthcare establishments and associations working in the field of disability, which have the skills to operate these Products, as well as companies in the context of action for the prevention of MSDs (hereinafter, the “Purchaser”).
ORTHOPUS reserves the right to refuse an order for Products if this capacity cannot be confirmed by the third party requesting such an order. ORTHOPUS does not offer its Products for sale to consumers.

ORTHOPUS offers Products that comply with the regulations applicable in France and the European Union. If the Purchaser is located outside the European Union, it shall have sole responsibility for the compliance of the Products with the regulations in the country concerned.

Any order implies, on the part of the Purchaser, acceptance without restriction or reservation of these General Terms and Conditions of Sale and the waiver of its own terms and conditions of purchase.

Consequently, the placing by the Purchaser of an order for Products with ORTHOPUS entails its full and complete acceptance of the GT&Cs.

The information featured on the ORTHOPUS website and its catalogues, offering circulars and prices are provided for information only and may be revised at any time. ORTHOPUS is entitled to make any modifications it deems useful.

ORTHOPUS reserves the right to alter or modify these GT&Cs at any time.

The GT&Cs then in force at the time of the order for Products placed by the Purchaser shall apply.

PRODUCTS OFFERED FOR SALE

The products offered for sale by ORTHOPUS, such as technical aids for arm mobility and their accessories, are defined as “Products”.
The Products offered for sale can be viewed on the ORTHOPUS website https://www.orthopus.com, in French and English, on brochures dedicated to each product and on other ad hoc communication media.

The main characteristics of the Products and in particular their specifications and functionalities as well as the illustrations and dimensional indications are presented in the media cited. This information is intended, without being exhaustive, to inform the Purchaser as fully as possible.

The Products offered for sale are also the subject of descriptive notices, included in the Instructions for Use (Manuel d’utilisation in French) which present the essential and functional characteristics of the Products as well as their conditions of use.
The notices for the Products offered for sale are available in French and English on the ORTHOPUS website: https://www.orthopus.com.
The Purchaser has sole responsibility for the selection and purchase of a Product.

QUALITY COMMITMENT

ORTHOPUS products are classified as class I medical devices under European Regulation 2017/745 on the CE marking of medical devices. Each of these products has a declaration of conformity drawn up by the manufacturer as well as technical documentation kept up-to-date to provide proof of the compliance of its products with the essential requirements of the CE marking (compliance with design and manufacturing conditions, results of risk analyses, etc.), and to implement quality assurance procedures.
These elements must be made available to the competent authorities for at least 10 years after the manufacture of the last product.

In order to comply with the European regulations on Class I medical devices (MDs), ORTHOPUS has set up a quality management system (QMS) that follows the recommendations of ISO 13485 in order to guarantee the safety of end users and the performance of products.

The Products are delivered in packaging intended to allow their storage without deterioration. ORTHOPUS invites any Purchaser to keep the packaging carefully so as to facilitate any return.

OBLIGATIONS CONCERNING MEDICAL DEVICES

The products sold by ORTHOPUS belong to the category of medical devices, as defined in Article 2 of EU Regulation 2017/745.

Materiovigilance: As part of the European materiovigilance system, the Purchaser must inform ORTHOPUS or its intermediary (distributor or reseller of medical equipment) without delay and at the latest:

  • within one (1) calendar day, of any case of serious threat to public health
  • within five (5) calendar days, of any case of death or unexpected serious deterioration in a patient’s state of health
  • within ten (10) calendar days, of any serious incident as defined in Article 87(1)(a) of EU Regulation 2017/745.

Traceability: The Purchaser shall provide a register including the traceability of all products delivered thereby for a period of ten (10) years or for the entire duration of use of the device.
Furthermore, in the event of a possible recall of ORTHOPUS products, the Purchaser must cooperate in order to transmit the information to the final user for a period of ten (10) years.

Post-marketing surveillance: The Purchaser shall communicate to ORTHOPUS any data relating to the quality, performance or safety of the products sold by ORTHOPUS, even if the identified event did not generate a risk to the health of the user or third parties. In particular, companies authorised to carry out repair operations on devices supplied by ORTHOPUS must at least once a year send ORTHOPUS a summary of the events encountered.
Obligation of the distributor: The Purchaser, if it is considered a distributor within the meaning of Article 2 of EU Regulation 2017/745, shall comply with the regulatory obligations relating to its status.
Storage conditions: The Purchaser must comply with the conditions governing the storage and transport of the medical devices supplied by ORTHOPUS.

PRODUCT ORDERS

Before the completion of the sale, ORTHOPUS shall submit to the Purchaser a quote specifying the Products requested by the Purchaser, their quantity, their price, the payment deadlines and terms, the validity period of the offer as well as the delivery address and the indicative delivery deadline.

To draw up its quote or offer, ORTHOPUS will ask the Purchaser for all necessary information.

Unless otherwise indicated, the validity period of ORTHOPUS quotes is one (1) month from their issue date.

The order for Products shall only be validly concluded upon receipt by ORTHOPUS of the quote signed by the Purchaser.

Any order sent by the Purchaser to ORTHOPUS, whether definitive or not, may not be withdrawn or modified by the Purchaser other than with the prior consent of ORTHOPUS. In this context, the price of any order withdrawn or cancelled by the Purchaser without the prior consent of ORTHOPUS shall remain due, without prejudice to any right to compensation for any damage resulting from the modification or withdrawal of the order.

PRICE

The prices applicable to the Products ordered by the Purchaser are those set out in the quote issued by ORTHOPUS and accepted by the Purchaser.

The pricing schedules in force for the Products may be communicated at the Purchaser’s request. ORTHOPUS reserves the right to change its prices at any time, with the change taking effect on the date indicated on the new price schedule.
The prices of the Products are fixed and not subject to revision during their validity period. They are expressed in euros excl. tax, excluding packaging, excluding taxes and duties of any kind, and are expressed individually, including in the event of international sales.

Unless otherwise stipulated, the costs of delivery of the Products, indicated on the quote accepted by the Purchaser shall be borne by the latter.
Where applicable, any tax, duty, customs duty or other duty to be paid pursuant to the regulations in force shall be borne by the Purchaser. Any change in the rate or amount of these duties may be reflected in the final price of the Products to be paid by the Purchaser.

DELIVERY

Delivery shall be made according to the Incoterm set at the time of the order of the Products, and by carrier to the address given by the Purchaser on placing its order for the Products.

The Purchaser acknowledges that it is the responsibility of the carrier to make the delivery, ORTHOPUS being deemed to have fulfilled its delivery obligation once it has handed over the Products ordered by the Purchaser to the carrier, which has accepted such Products without reservations.

It is also the responsibility of the Purchaser to take out specific insurance if Purchaser considers the cover provided by the carriers to be insufficient.

The Products will be delivered according to availability and in the order of arrival of orders. ORTHOPUS is authorised to make total or partial deliveries.

The delivery times stipulated when orders are placed are for information only and any delays, in particular those resulting from circumstances outside the control of ORTHOPUS, do not entitle the Purchaser to cancel the order, refuse the Product(s) or claim penalties or damages.
ORTHOPUS may not be held liable in the event of a delay in the delivery time indicated.

The deadline indicated is also automatically suspended by any event beyond the control of ORTHOPUS and resulting in a delay in delivery. In any event, delivery within the deadline may only take place if the Purchaser is up to date with all its obligations towards ORTHOPUS.

If the delivery is delayed due to the Purchaser, the resulting costs shall be borne in full by the Purchaser.
If the Purchaser comes to take possession in person or through any service providers (courier, carrier, etc.) of the Products directly from ORTHOPUS, the Product risk as well as the costs and risks related to their delivery shall be transferred and borne by the Purchaser from this day forward.
In any event, the transfer of the risks related to the Products shall always take place at the time of their delivery to the Purchaser, the persons subrogated therefore, or any third party designated thereby.
Therefore, starting from such delivery, the Purchaser shall bear and be liable for any damages and defects that may be caused to the Products.

TAKING DELIVERY OF THE PRODUCTS

The Purchaser shall take receipt of the Products ordered on the day of their delivery. Upon receipt, the Purchaser must check that the delivered Products are compliant with the order form and that there are not visible defects.

Following their receipt, in the event of a reservation related to damage or missing Products linked to their transport, the Purchaser is responsible for mentioning this

  • for deliveries in France on the delivery note and confirmed by the Purchaser, within 3 days of receipt of the Products, on the one hand, to the carrier under the conditions set out in Article L.133-3 of the French Commercial Code, by registered letter with acknowledgement of receipt, accompanied by a copy of the delivery note concerned, and, on the other hand, to ORTHOPUS by any written means (e.g. email with a copy of the delivery note), under penalty of time bar with regard to ORTHOPUS of the reservations or claims concerned.
  • for international deliveries: on the delivery slip and confirmed by the Purchaser, within 5 days of receipt of the Products, on the one hand to the carrier in writing, accompanied by a copy of the delivery slip in question, and, on the other hand, to the Purchaser, by any means in writing (e.g. email with a copy of the delivery slip), subject otherwise to the Purchaser being time barred with regard to the reservations or claims in question.

Furthermore, and without prejudice to the measures to be taken with regard to the carrier, any claim regarding visible defects or the visible non-compliance of the Products delivered compared with those ordered must be made in writing accompanied by photos demonstrating the compliance issue invoked, within three (3) days of the date of their receipt by the Purchaser to ORTHOPUS.

In the event of a visible defect or proven compliance issue regarding the Products delivered in relation to those ordered under the conditions referred to above, ORTHOPUS undertakes, at its choice, either to replace the non-compliant Products with identical or equivalent Products at its expense, or to reimburse the Purchaser for the price of the non-compliant Products in the form of a credit note issued to the Purchaser, subject to the actual return to ORTHOPUS of the disputed Products in the condition in which they were received. In any event, ORTHOPUS shall not be bound by any exclusion whatsoever of damages, penalty clause or other compensation

Any Product returned without complying with these terms will not give rise to any refund or replacement.

PAYMENT CONDITIONS

Payment is deemed to have been made on the date on which the amount due by the Purchaser is actually made available to ORTHOPUS.
Unless otherwise agreed between the parties in writing, ORTHOPUS’ invoices are payable thirty (30) days from the invoice date, in euros at ORTHOPUS’ head office in Nantes, notwithstanding any dispute.

Any failure to pay on the due date shall result in the application, automatically and without prior formal notice, of late payment penalties fixed at three (3) times the statutory interest rate in force from the date of payment stipulated on the invoice until full payment of the amount, as well as a fixed indemnity for recovery costs in the amount of forty (40) euros, if the recovery costs incurred by ORTHOPUS are less than this amount, and, in excess of this amount, of an amount equal to the amount actually incurred by ORTHOPUS to obtain payment of this amount.
Furthermore, in the event of late payment, ORTHOPUS reserves the right to suspend or cancel the Purchaser’s current orders without prejudice to any other recourse.

Furthermore, ORTHOPUS retains full ownership of the delivered Products until full and effective payment of their price by the Purchaser, without prejudice to the transfer of the Product risk to the Purchaser from the date of delivery.

In the event of the resale of the Products by the Purchaser before full payment of their price to ORTHOPUS, the right of ORTHOPUS under its retention of title clause shall be automatically transferred to the resale price of the Products concerned by the Purchaser.

COMMERCIAL WARRANTY

The Products sold are covered by a 2-year commercial warranty aimed at covering manufacturing and design defects of the Products. This warranty takes effect from the delivery of the Products to the end customer to whom the Purchaser has supplied the Product.
It does not cover defects caused by abnormal or wrongful use or resulting from a cause unrelated to the intrinsic qualities of the Products.
In the event of a defect in the Products covered by this commercial warranty, the Purchaser shall notify the latter to ORTHOPUS according to the procedure indicated by the latter, in particular by communicating photographs of the Products in order to highlight the defect invoked or all the documents requested. In this respect, the Purchaser must attach to its notification the delivery note for the Products concerned to their end customer. Following this notification, ORTHOPUS will analyse the Purchaser’s warranty claim and may request the return of the Products in order to carry out its appraisal. In this case, the Purchaser shall return the Products in their original packaging.
In the event of a defect covered by the warranty, ORTHOPUS shall process the defect in question as it sees fit, either by carrying out the necessary actions/repairs on the Products in question or by replacing them.
In any event, Orthopus shall not be bound by any exclusion whatsoever of damages, penalty clause or other compensation
Any covering during the period of the applicable warranty may not result in an extension of the duration of the said warranty.

In the context of a request to take charge of the Products not covered by the commercial warranty described in this clause, a quote shall be drawn up by ORTHOPUS for acceptance before any intervention on the Products concerned.

LIABILITY

ORTHOPUS shall fulfil the Purchaser’s order in accordance with best practices and with the care and attention of a professional, pursuant to the legislation and regulations in force.

Only Products expressly ordered by the Purchaser, according to the agreed specifications, at the time of ordering, in particular those appearing in the order documents, are the responsibility of ORTHOPUS.

The Purchaser undertakes to provide ORTHOPUS with the cooperation necessary for the supply of the Products and, in particular, to respond to any request for necessary information from ORTHOPUS.

The Purchaser acknowledges and accepts sole liability for the information and documents sent and communicated to ORTHOPUS for the performance of its order, in such a way that ORTHOPUS cannot be held liable in the event of an error, breach or failure to inform on the part of the Purchaser.

In any event, ORTHOPUS may, more generally, only be held liable in the event that the Purchaser is able to demonstrate the existence of fault attributable thereto. In the absence of such proof, ORTHOPUS does not accept any liability for any direct and indirect consequences associated with the Products.

If ORTHOPUS were to be found to be liable, and unless otherwise specifically stipulated or provided by a mandatory provision of law, ORTHOPUS shall only be liable for any tangible damage and any foreseeable and direct losses suffered by the Purchaser, insofar as the Purchaser provides evidence that the breach or failure by ORTHOPUS is the cause of such loss. Indirect losses include production losses, loss of profit, loss of clientele and loss of opportunities.

ORTHOPUS cannot therefore be held liable under any circumstances:

  • for compensation for indirect damage, any loss(es) with regard to operation, productivity, profit, brand image, contract(s), investment(s) or time, even if ORTHOPUS has been informed of the possibility of such losses;
  • in the event of force majeure as defined in clause 12 below.

In any event, ORTHOPUS shall not be held liable and no compensation shall be payable in the following circumstances:

  • actions or deeds of the Purchaser (including the obligations imposed under the Agreement arising from these GT&Cs) that make ORTHOPUS physically unable to fulfil its obligations;
  • incorrect fulfilment of an order resulting from erroneous information provided by the Purchaser and/or featuring in the documents provided by the Purchaser.

FORCE MAJEURE

Under no circumstances may ORTHOPUS be held liable in the case of an occurrence of an event of force majeure.
Force majeure events affecting ORTHOPUS’ obligations are events beyond its control and that it could not reasonably be expected to foresee, insofar as the occurrence of such events makes the performance of its obligations more difficult or more onerous.

Such events shall include (without limitation) disruptions to means of transport or communication, government actions, changes to the regulations applicable to these GT&Cs or to ORTHOPUS, events that may disrupt normal operations at ORTHOPUS or its partners (suppliers and sub-contractors) such as strikes, lock-outs, total or partial short-time working, a shortage of raw materials, accidents, machinery breakdowns, a failure of equipment or production units, fires, flooding, supply issues or transport disruptions or delays, pandemics, epidemics or lockdown measures imposed by the government or the authorities.

PERSONAL DATA

Data processed by ORTHOPUS for its own needs

In the context of the provision of the Products ordered by the Purchaser, the Purchaser may be required to provide personal data relating to the Purchaser or its employees that ORTHOPUS may use for its own purposes.

The collection of personal data is primarily necessary in order to allow ORTHOPUS to ensure the proper completion of Product orders placed by the Purchaser.

As such, these data may be sent to potential sub-contractors whose services are retained by ORTHOPUS during the fulfilment of Product orders, as well as to the tax authorities or a court in order to allow ORTHOPUS to comply with its legal and administrative obligations or in connection with the management of a dispute.

Secondly, some of the data thereby collected may also be used by ORTHOPUS to send the Purchaser and its employees emails and information in order to inform them of its news, its promotional offers or invite them to events organised by ORTHOPUS or its partners.

ORTHOPUS shall take all necessary precautions to ensure that the data disclosed by the Purchaser or its employees, or to which it may have access for its own purposes, remains secure and, in particular, is not distorted, damaged or accessed by unauthorised third parties.

ORTHOPUS informs the Purchaser and its employees whose data may be collected in the manner described above that, under the General Data Protection Regulation (EU Regulation 2016/679), they have a right to access, alter and erase such data, a right to restrict processing, a right to object and a right to portability in respect of their data. Any data subject also has the right not to be the subject of an individual decision based solely on automated processing, such as profiling.

The Purchaser and its employees may also use their right to object provided for by the regulation to refuse emails from Orthopus containing its news, information on its business activities and offers.

These rights may be exercised by sending an email to [usercare@orthopus.com], by post: ORTHOPUS, Le Karting, 6 rue Saint Domingue, 44200 Nantes, or according to the procedure indicated on the information email sent by ORTHOPUS.

Data subjects also have the right to lodge a complaint on the processing of their personal data by ORTHOPUS with the CNIL (the French Data Protection Commission).

ORTHOPUS undertakes to retain the personal data that it collects for a period that does not exceed the purposes for which they are processed.

Data processed by ORTHOPUS in the name and on behalf of the Purchaser

In the context of the supply of the Products ordered by the Purchaser, ORTHOPUS may be required to process data belonging to the Purchaser in the name and on behalf of the latter.

In accordance with the General Data Protection Regulation, ORTHOPUS shall:

  • process the data solely for the purposes of fulfilling the Purchaser’s order for the Products and for the purpose(s) defined within the framework of the latter,
  • process the data entrusted in accordance with the purposes agreed with the Purchaser, as well as the written instructions sent by the latter. In this respect, the Purchaser undertakes to make any instructions formal and send them in writing to ORTHOPUS. Failing this, ORTHOPUS shall be held harmless in this regard. ORTHOPUS shall inform the Purchaser if it considers that a given instruction constitutes a breach of the General Data Protection Regulation,
  • preserve the confidentiality and security of the data concerned, in particular by implementing appropriate organisational and technical measures. In this respect, ORTHOPUS cannot in any way be held liable for security defects attributable to the Purchaser,
  • ensure that the persons authorised within ORTHOPUS to access the data respect the confidentiality of such data,
  • take into account, with regard to its tools and services, the principles of data protection by design and data protection by default,
  • cooperate with the Purchaser in order to enable the latter to assess and document the compliance of its processing of personal data, and thus make available to the Purchaser the documentation necessary to enable the latter to assess compliance with its obligations,
  • not transfer data to States located outside the European Union without first informing the Purchaser.
    For the purposes of supplying the Products ordered by the Purchaser, ORTHOPUS may use subcontractors. The use of this subcontractor may involve the transfer to the latter of the Purchaser’s personal data, which the Purchaser declares that it accepts. ORTHOPUS shall ensure that it informs the Purchaser of the identity of the subcontractor(s) to be used thereby.

In this context, ORTHOPUS shall ensure that the subcontractor used thereby processes the data entrusted to it in accordance with the provisions of this clause.

The Purchaser undertakes, for the entire duration of its relations with ORTHOPUS, to comply with all of the obligations applicable thereto within the meaning of the General Data Protection Regulation in its capacity as Data Controller of the data concerned.

In particular, it is the responsibility of the Purchaser to provide the persons whose data are entrusted to ORTHOPUS with the information provided for by the said Regulation, in particular, the rights they have and the purposes for which it collects their data, to process these data in a fair, transparent, lawful and proportionate manner and to take all necessary measures to preserve their confidentiality and security in the context of the processing of such data carried out thereby.

Consequently, the Purchaser represents that it guarantees ORTHOPUS against any claim or recourse related to any potential non-compliance by the Purchaser with its obligations.

In the event that the persons whose data are entrusted were to exercise directly toward ORTHOPUS any one of their rights recognised by the General Data Protection Regulation, ORTHOPUS shall ensure that this request is sent by any means in writing at its convenience directly to the Purchaser, which shall be solely responsible for the processing thereof.

ORTHOPUS shall notify the Purchaser as soon as possible after becoming aware of this and by any means in writing at its convenience, of any breach of the personal data which it will therefore process on behalf of the Purchaser. This notification shall be accompanied by any useful documentation defined by ORTHOPUS allowing the Purchaser, if necessary, to notify this breach to the competent supervisory authority or to the individuals whose data are concerned by this breach.

At the end of the implementation of the order for Products giving rise to the processing of the Purchaser’s data by ORTHOPUS, the latter may, in agreement with the Purchaser:

  • destroy all of the personal data entrusted by the Purchaser,
  • return all personal data to the Purchaser,
  • ensure the continuation of the processing of the data concerned insofar as it may be used in the context of a new order for Products from the Purchaser.

The Purchaser shall communicate its instructions in writing at the end of the order of the Products concerned to ORTHOPUS, which shall process them as soon as possible.

GOVERNING LAW - DISPUTES

These General Terms and Conditions are subject to French law, excluding any international treaty.

In the event of a dispute relating to the interpretation or performance of the agreement resulting from these GT&Cs or the supply of the Products, the Purchaser and ORTHOPUS shall first seek an amicable agreement and shall provide each other with all necessary information for this purpose.

If no amicable settlement to the dispute is reached within a maximum of three (3) months following its notification by one party to the other party, the said dispute must be submitted to the Commercial Court of Nantes, to which the parties attribute exclusive jurisdiction, except where another jurisdiction is designated as having jurisdiction by public policy rules.

This clause shall apply even in the event of summary proceedings, interlocutory applications or multiple defendants or the introduction of third parties, and irrespective of the method and terms of payment, without it being possible for any jurisdiction clauses that may exist in the Distributor’s documents to prevent the application of this clause.

ENTRY INTO FORCE

The General Terms and Conditions come into force on February 14, 2024.

CONTACT

CONTACT

  • Email : usercare@orthopus.com
  • Address : 
    ORTHOPUS
    Le Karting, 
    6 rue Saint Domingue 
    44200 NANTES
    (FRANCE) 
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