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Capitalised terms shall have the meaning set forth in Annex 1.
The present general terms and conditions (the "General Terms and Conditions") apply to all existing and future contractual relationships between the Manufacturer and the End User, including:
(hereinafter collectively the Agreements" and each individually an "Agreement").
Deviation from the present General Terms and Conditions is only possible by express written agreement between the Parties.
Offers made by the Manufacturer are not binding unless they are expressly stated to be binding. Obvious mistakes or errors in an offer (either publicly or among parties) shall therefore not bind the Manufacturer.
The End User's acceptance of an offer from the Manufacturer (via a quotation or order form), which contains all the essential elements and is explicitly considered by the Manufacturer to be a binding offer, will result in the formation of an Agreement.
When the Manufacturer receives an order for a Product from the End User, it may confirm this order in writing within a period of 15 days, with an indication of the estimated date of delivery. This written confirmation shall lead to the formation of a Sale between the Parties.
Each Sale is subject to the Manufacturer's Warranty, unless if a Service Agreement has been concluded between the Manufacturer and the End User.
All prices are always expressed in euro, including VAT and other taxes, but excluding other costs (of delivery, packaging, etc.). Prices always depend on the price formula chosen by the End User.
Agreements are concluded at the prices applicable/communicated at the time of the conclusion of the Agreement.
5.1.1. In the event of a Sale, the Manufacturer shall provide the End User with an invoice at the delivery of the Product, indicating the price and any costs to be charged.
5.1.2. In accordance with the terms of the Manufacturer's Warranty and the Services Agreement, the Manufacturer may invoice the End User separately for additional services such as maintenance and repairs. The Manufacturer shall provide the End User with an invoice when the Product is made available again to him or her after the services have been provided.
5.1.3. Invoices will always be transferred to the End User by electronic mail. In addition, the Manufacturer may also hand an invoice on paper to the End User.
5.2.1. Invoices are payable in euro and within a period of 30 days following the invoice date, in accordance with the payment instructions stated on the invoice. A payment is deemed to be effective as soon as the Manufacturer's account is credited.
5.2.2. Payments for which no invoice is issued (such as fees under the Services Agreements) are payable in accordance with the special terms and conditions specified in the specific Agreement.
Any disputes relating to the invoice shall be notified to the Manufacturer within 15 days following the invoice date, in accordance with article 15. As from the expiry of this period, an irrefutable presumption that the End User has accepted the invoice applies. Disputes shall not affect the End User’s payment obligation in accordance with article 5.2.
The End User shall owe the statutory reference interest, automatically and without prior notice of default, on any unpaid amount, from the day following the due date.
The Manufacturer also retains the right to obtain compensation from the End User for its actual damages, including recovery costs.
As long as the End User has not complied with his or her payment obligations, the Manufacturer reserves the right to suspend the performance of any other obligation until full payment of the due amounts.
Unless otherwise agreed, delivery of a Product after Sale shall take place at one of Certified Prosthetist’s establishments. Upon delivery, the Certified Prosthetist shall also install the Product, apply it to the End User, and provide all necessary information for the use of the Product.
Delivery shall take place within a reasonable time, on the date confirmed by the Manufacturer. However, the delivery date communicated is indicative, and may be modified by the Manufacturer if reasonably justifiable. In any case, the delivery period may be suspended during and in case of supply delays, strikes, power cuts, staff outages and cases of force majeure.
Shipment of the Product by and to the Manufacturer is organised by the Manufacturer, in consultation with the Certified Prosthetist. A shipment may be necessary, for example, for delivery or in case of a maintenance or repair of the Product.
The Product shall always be shipped in its original packaging, together with the accessories provided with it and the service booklet.
The costs relating to shipping and packaging of the Product shall in principle be borne by the Manufacturer. If the shipment is made via the Certified Prosthetist, the End User shall be responsible for the delivery to and the collection of the Product from the Certified Prosthetist.
The costs of shipment can be recovered from the End User if the latter has wrongfully tried to invoke free repairs or maintenance under the Manufacturer’s Warranty or the Service Agreement. As the case may be, such costs shall be passed on to the End User by means of an invoice in accordance with article 5.1.
8.3.1. In the event of shipment of the Product to the End User, the risk of the Product shall pass to the End User at the time of provision at the address of the End User, or at one of the Certified Prosthetist’s establishments (if the latter intervenes).
8.3.1. In case of shipment of the Product to the Manufacturer, the risk of the Product passes to the Manufacturer at the moment of provision of the Product at one of the Manufacturer’s establishments, or one of the Certified Prosthetist’s establishments (if the latter intervenes).
The Products remain the property of the Manufacturer until full payment of the price by the End User, including any default interest and costs.
Until full payment of the Products, the End User undertakes not to transfer ownership or pledge the Products without the seller's prior written consent. The End User undertakes to inform the Manufacturer of any seizure performed by third parties on the Products for which the price has not been fully paid.
In the event of bankruptcy, the End User acknowledges that this clause shall take full effect in accordance with the provisions of Article XX.149 CEL.
Apart from the warranties included in the present General Terms and Conditions or warranties explicitly agreed upon with the End User (under the Manufacturer's Warranty or the Services Agreement), the Manufacturer makes no warranty of any kind, either express or implied and without limitation, including any warranty of merchantability or warranty of fitness for a particular purpose.
The Manufacturer grants a Manufacturer's Warranty for sales of Products for which no Service Agreement has been concluded. The terms and conditions thereof of this are set out in the Manufacturer's Warranty.
The End User may also claim a statutory warranty under articles 1641 - 1649octies of the old Civil Code, which, in the event of a conformity defect, grants him a right to free remedy against the final seller of the Product. The statutory warranty is not affected by the Manufacturer’s Warranty. More information regarding the legal guarantee can be found on the website of FPS Economy: https://economie.fgov.be/en/themes/consumer-protection/guarantee/guarantee-act (hereinafter the "Statutory Warranty").
This Statutory Warranty may only be invoked against the Manufacturer if the Manufacturer acts as the final seller of the Product.
The conditions of the Statutory Warranty are as follows:
The Manufacturer's liability is limited to direct and foreseeable damage on the part of the End User.
The Manufacturer declines all responsibility for the consequences of the use of a Product that is not in accordance with the documentation and instructions prepared by the Manufacturer (in particular regarding the operation, function and medical purpose of the Product), including the User Guide.
The rights of the Manufacturer relating to his Intellectual Property and his activities and the goodwill associated with them remain the exclusive property of the Manufacturer. The Intellectual Property is not transferred or assigned in any way to the End User. All the information or material protected by the Intellectual Property (including the Software, the promotional material, the know-how, codes, production processes, etc) shall remain the exclusive property of the Manufacturer and shall be treated as Confidential Information. The End User shall not pursue the registration of the Intellectual Property Rights without the express consent of the Manufacturer.
The Confidential Information shall remain the exclusive property of the Party disclosing it, and shall not be used for any purpose other than the execution of the agreements between the Parties without the consent of that Party. The Confidential Information shall not be disclosed to third parties and shall not be used after the termination of the cooperation.
The Manufacturer shall process the End User's personal data for purposes of the Agreements. As a data controller, the Manufacturer shall comply with all privacy-related regulations, in particular the General Data Protection Regulation (2016/679). The nature and purpose of the data and processing, the legal basis of the processing and the rights of the End User are set out in the Privacy Statement.
Unless otherwise specified, all notices or communications between the Manufacturer and the End User related to the Sale must be in writing. Such notices or communications may validly be given by e-mail as far as the Manufacturer is concerned to the e-mail address info@axilesbionics.be.
The General Terms and Conditions and the Sales are subject to Belgian law.
Disputes arising out of or in connection with these General Terms and Conditions or the Sales shall be within the exclusive jurisdiction of the courts of Brussels.
If any provision of these General Terms and Conditions should be unenforceable or conflict with a provision of mandatory law, this shall not affect the validity and enforceability of the other provisions of the General Terms and Conditions, nor the validity and enforceability of that part of the provision in question that is not unenforceable or conflicts with mandatory law. Where appropriate, the Parties shall immediately enter into good faith discussions with a view to replacing the invalid or unenforceable provision by a provision that is valid and enforceable and that most closely matches the intent underlying the invalid or unenforceable provision.
1. Definitions
"General Terms and Conditions": has the meaning set out in article 2;
"Confidential Information": all confidential information relating to a Party, including technical information (inter alia relating to the products), the information forming part of the patent application, product specifications, software, codes, customer lists, price lists, trade secrets, and all information constituting Intellectual Property;
"Services Agreement": an agreement concluded between the Manufacturer and the End User regarding the maintenance and repairs of the Product by the Manufacturer against the payment of a fee by the End User, within the framework of the "prosthetics as a service" purchasing model;
"End User": The natural person who purchases the Product from the Manufacturer or a Certified Prosthetist for exclusive personal use;
"Manufacturer's Warranty": the commercial warranty granted by the Manufacturer to the End User for sales of Products for which no Service Agreement has been entered into;
"Manufacturer": Axiles Bionics BV, having its registered office at Raketstraat 64, 1130 Brussels and registered in the CBE under number 0719.695.854;
"Defect": has the meaning set out inaArticle 10.3.2;
"Certified Prosthetist": the entity which has sold the Product to the End User, and which has obtained the Manufacturer's express written permission to do so;
"Intellectual Property" : the intellectual property rights of the Manufacturer as well as intellectual property rights relating to the Products (as defined below), including company names, trade names, domain names, logos, brands, patents, patent applications, patentable inventions, design patents, copyright and neighbouring rights, rights in software, rights in databases, trade secrets, product formulas, know-how, technology and manufacturing processes, customer lists and other Confidential Information;
"User Guide": the instructions and guidelines for the End User's use of the Product (also referred to as "Instructions For Use" or "IFU") which will be provided to the End User together with the Product, any changes to which will be notified to the End User without delay;
"Agreements" : has the meaning set out in article 2;
"Parties" : the Manufacturer and the End User;
"Privacy Statement": The Manufacturer's privacy statement;
"Product" : any medical device manufactured by the Manufacturer for the purpose of sale;
"Software": the operating system of the Product, including the data generated by it;
"Sales": has the meaning set out in article 2;
"Statutory Warranty": has the meaning set out in article 10.3.1.