Terms and Conditions of Sale

1. Definitions

In these General Terms and Conditions of Sale, terms and expressions beginning with a capital letter, whether used in the singular or plural, shall be defined as follows :

1.1 Product: medical devices, equipment and consumables, or services offered by Diabeloop on the date of the order 

1.2 Diabeloop: the company Diabeloop, a limited company with its registered office at 17 rue Félix Esclangon – 38000 Grenoble, registered in the Grenoble Trade and Companies Register under number 810 416 438

1.3 Medical Devices: any Product placed on the market as a medical device as defined by Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 concerning medical devices or by directive 93/42/EEC of June 14, 1993 relating to medical devices.

1.4 Customer: any natural or legal person who places an order with Diabeloop, whether or not the Customer is the end user and/or recipient of the Products.

1.5 General Terms and Conditions of Sale or GTC: the present general terms and conditions of sale, the purpose of which is to define the terms and conditions according to which Diabeloop sells the Products to the Customer and by which the Customer acquires the Products under the conditions hereafter defined

1.6 Contract: means any contract concluded between Diabeloop and the Customer including the GTC

2. Conditions of application

2.1 Any contract concerning the sale of Products by Diabeloop is governed by the GTC, to the exclusion of any other document such as leaflets, catalogs, documentaries issued by Diabeloop, which are only given for information purposes and have only an indicative value. Such a contract is formed at least by the order form and the GTC. In case of contradiction between any contractual document and the GTC, the GTC shall prevail subject to express contractual provisions.

2.2 Any order of Products by the Customer implies the Customer’s express and unreserved acceptance of the GTC (which are attached to the Agreement with the Client), which shall prevail over any contrary provision appearing on the order forms or on any other document issued by the Customer. All additions, deletions, modifications or deletions to the GTC that are not approved by Diabeloop are void. Diabeloop hereby expressly rejects all general terms and conditions of purchase of the Customer unless Diabeloop expressly agrees to such general terms and conditions of purchase of the Customer.     

2.3 The Customer acknowledges that he has read the GTC and fully understands the terms and conditions prior to placing an order. The Customer declares that he orders Products and concludes the GTC in his name, for his account and for his professional needs as a trader.

2.4 The fact that Diabeloop does not take advantage of any of the provisions of the GTC at a given time cannot be interpreted as a waiver of the rights it has under the GTC. 

2.5 In the event of special agreements between Diabeloop and the Customer, these agreements may deviate from certain provisions of the GTC, the other provisions of which remain applicable as far as they are not contrary to the GTC. Any modification of the GTC by Diabeloop or any acceptance of a specification or condition of any kind by Diabeloop can only be taken into account by the Customer after a formal agreement has been signed. Diabeloop’s consent in any respect cannot be tacit: it is always express and written.

2.6 Diabeloop reserves the right to modify and update, without prior notice and at any time, the GTC. 

3. Products

3.1 Diabeloop may at any time and regardless of its characteristics modify any Product in its catalog. These modifications may occur at any time, including after the Customer’s order if these modifications result from the application of standards, texts or regulations of any kind, applicable to the Products.

In such a case, Diabeloop undertakes to inform the Customer. In the event that a change in the characteristics of the Products after the Customer’s order prevents the Products from being used in accordance with the Customer’s intended use, the Customer shall inform Diabeloop, which shall, at its option, refund or replace the Products concerned free of charge.

3.2 Diabeloop reserves all property rights and copyrights on all technical documents provided with the Products. These may not be copied or reproduced. They may be used for the maintenance and operation of installations and devices supplied by Diabeloop.

4. Offers

4.1 Diabeloop’s offers never constitute recommendations by Diabeloop. The choice of the Products is solely up to the Customer in view of the use he wishes to make of them. He remains the only one responsible for this choice. It is up to the Customer, if necessary, to carry out the necessary checks to ensure that the Products ordered are compatible with the intended use.

4.2 This clause is a determining condition of the sale of the Products by Diabeloop.

4.3 Diabeloop’s offers are made subject to the availability of the Products at the time the order is received.

5. Orders

5.1 Orders must contain the identity and contact details of the Customer, the delivery address, the name of the Products ordered, their reference and their unit price excluding VAT as they appear on the price offer sent by Diabeloop. The information provided by the Customer at the time of the order is binding. Diabeloop can in no way be held responsible in case of erroneous information provided by the Customer on the order, resulting in the impossibility and/or delay in the delivery of the Products, and/or a defect in the conformity (catalog reference) and/or the quantity of the Products ordered.

5.2 Acceptance of the order by Diabeloop takes place either by written confirmation of the order, or tacitly if Diabeloop does not reject the Customer’s order within five (5) working days of its receipt.

Any modification or cancellation of the order requested by the Customer must be received in writing by Diabeloop before the Products are shipped and will be considered at Diabeloop’s sole discretion.

6. Prices

6.1 All prices are in Euros and exclusive of tax.

6.2 The Products are invoiced at the rate applicable on the date of delivery or in accordance with the current price offer sent by Diabeloop. Any tax, duty, fee or other service to be paid in accordance with the laws and regulations of the countries concerned are to be paid by the Customer. Delivery costs are at the expense of the Customer (unless expressly agreed otherwise).

6.3 The prices are periodically revised and will be communicated to the Customer at the time of any modification or on simple request. Diabeloop expressly reserves the right to withdraw at any time from its catalog and its price list, all or part of the Products appearing therein, to make all the modifications it deems useful without being obliged to notify the Customer.

7. Terms of payment

7.1 Invoices are payable by the Customer by bank transfer to the attention of Diabeloop. Unless otherwise agreed, invoices are to be paid upon receipt.

In the absence of payment within this period, the Customer will be automatically liable for late payment penalties payable as from the day following the date of payment indicated on the invoice and calculated by applying, per day of delay and to the totality of the sums due, a rate equal to the interest rate applied by the European Central Bank to its most recent refinancing operation plus 10 percentage points. The Customer will also be liable to pay a fixed collection fee of forty (40) Euros, without prejudice to the additional compensation that Diabeloop, upon justification, may request from the Customer if the collection costs are higher than this amount.

7.2 Possible complaints do not exempt the Customer from paying each invoice on the due date. 

7.3 In the event of a change in the Customer’s situation for whatever reason, or of an incident or delay in payment, or of a change in legislation, Diabeloop will have the right to modify the terms of payment granted or to demand guarantees, including for orders in progress.

7.4 The Customer’s obligation to pay is only considered to be fulfilled when all sums due have been received on Diabeloop’s account and are at its free disposal. Payments are always considered to be made for the oldest debt. In the event that legal action should be taken to obtain payment of the amounts due, Diabeloop is entitled, without prejudice to the legal costs, to claim compensation for the damage suffered. The amount of the invoices can in no way be reduced by the Customer from the amounts that may be owed to him by Diabeloop.

8. Delivery

8.1 Delivery is made by handing over the Products by Diabeloop’s carrier to the Customer at the address mentioned on the order.

Deliveries are made in accordance with the Incoterm EXW 2020. (ex works including vehicle loading, excluding delivery charges, import declarations, VAT, customs charges and any local taxes). In case of sea transport, the incoterm applicable to deliveries will be indicated on the Order Form.

8.2 The Products are shipped in specific packaging and wrapping in view of their medical destination and must be transported and stored in conditions such that they cannot be altered, in particular due to exposure to excessive heat or humidity. Packaging is an integral part of the Products and must not be used for any purpose other than that for which it is intended. Non-consumable transport packaging remains the exclusive property of Diabeloop and must not be damaged in any way. They must be returned to the place indicated by the customer service, in perfect condition. 

8.3 The delivery times indicated by Diabeloop are given as an indication only. Diabeloop indicates delivery dates on the basis of the conditions existing at the time of their fixing with regard to the supply of materials and manufacturing possibilities, which may be modified if the order confirmation arrives late.

8.4 Delays in delivery do not give rise to penalties for delay, deductions, damages or the refusal or cancellation of a current order, irrespective of the cause or consequences of such delays, as long as Diabeloop has informed the Customer before the initial planned delivery date.

Diabeloop is allowed to make deliveries in whole or in part.

8.5 Control and transfer of risk

8.5.1 The transport risks of the Products shall pass to the Customer as soon as they leave the factory.

8.5.2 The Customer undertakes not to discharge the carrier until he has ensured that the delivery is complete and in perfect condition.

8.5.3 The Customer must notify Diabeloop of the conformity of the Products within 48 hours in the form of a notice of receipt. If not, the delivery is considered as conforming.

8.5.4 The Customer may not refuse a partial order if Diabeloop has notified him before shipment.

8.5.5 The reservation of ownership of the Products does not affect the transfer of risk.

9. Reservation of ownership

9.1 Diabeloop reserves the ownership of the delivered Products until the complete payment of the outstanding invoices corresponding to the Products.

9.2 The default of one of the exchanges or part of the price can lead to the implementation of the property reserve without the need for any prior formal notice.

9.3 These provisions do not prevent the transfer to the Customer, upon delivery, of the risks of carriage and deterioration of the Products sold as well as any damage they may cause.

10. Suspension/Cancellation

10.1 Diabeloop reserves the right, by any written means, to suspend and/or terminate an order of the Customer in particular in case of :

• non-payment or delay in payment of all or part of the price of an order on the due date by the Customer
• failure of the Customer to fulfill one of its obligations

10.2 The suspension or termination will be acquired automatically and by right immediately upon receipt of the information referred to in the above points, without the need for any prior formal notice or judicial authorisation. 

In this case, Diabeloop reserves the right to repossess the Products already delivered without prejudice to any damages to which it may be entitled as a result of the breach in question. 

11. Non-conformity of the Products – returns

11.1 The Customer is obliged, upon receipt of the Products from the carrier, to check the quality, quantities, references and conformity of the Products ordered.

Complaints about apparent defects or the non-conformity of the Products ordered in relation to the order must be made in writing with a request for acknowledgement of receipt within forty-eight (48) working hours from the date of receipt of the Products by the Customer. After this period, no complaint concerning apparent defects or the conformity of the Products can be taken into account by Diabeloop.

11.2 The Customer must indicate in his complaint the delivery note number, the article designation and the batch number of the Product. The Customer must provide any justification as to the reality of the non-conformities found. The Customer will allow Diabeloop to proceed with the observation of these non-conformities.

11.3 No Product can be returned without prior written agreement from Diabeloop. Depending on the agreement on the return, the modalities of return, organized by the Diabeloop carrier, are specified to the Customer. In any case, the Product must be returned in good condition, in its original packaging and accompanied by the return form sent by Diabeloop.

11.4 Returns accepted by Diabeloop will give rise, at Diabeloop’s choice, to the free replacement, in the same quantities, of the Product recognized as not conforming to the order or to the reimbursement of the sums engaged corresponding to the returned Products; excluding any other indemnity or damages and interests.

11.5 Return costs may be applied in exceptional cases (Except in the case of the implementation of the warranty as defined in article 12, costs of restocking will be invoiced to the Customer) 

12. Liability and warranty

12.1 The components of the kit are guaranteed for two (2) years, i.e. the pumps, the terminal, and according to the provisions below : 

Consumables are not guaranteed.

12.2 Diabeloop represents and warrants that it has all necessary rights, titles, licenses and authorizations to sell the Products.

12.3 Diabeloop also represents and warrants that the Products it supplies comply with the European and national laws and regulations applicable to them in the countries in which the Products may be marketed, in force on the day of the order.

12.4 Diabeloop declares and guarantees that it has all the intellectual property rights necessary for the purposes of the present contract. In this respect, Diabeloop indemnifies the Customer against any claim, demand or action for infringement relating to the Products, provided that the Customer promptly notifies Diabeloop of such claim or action, allows Diabeloop to defend and/or settle such claim on its own, and provides Diabeloop with all necessary assistance in the defense and/or termination of the dispute. Diabeloop may, at its sole discretion, obtain the right for the Customer to continue to use the Products, modify/replace the Products with Products that no longer infringe the rights of the third party, or recall the Products and reimburse the Customer for the price paid by the Customer for the relevant Products.

12.5 Notwithstanding the above, Diabeloop shall not be liable for any claim, demand or action resulting from the use of the Products not authorized by the GTC or not respecting the terms and conditions of use provided for in the GTC as well as outside the indications of the Products which would be qualified as medical devices.

12.6 Subject to any legal provision of public order, Diabeloop’s obligations are limited to the sale and delivery of Products that comply with the requirements of the French and European regulations in force for this type of Products, to the exclusion of any use and/or implementation, which remains the Customer’s own business.

12.7 The Products benefit from legal guarantees only, in any case, Diabeloop’s guarantee will be limited to the free replacement, in the same quantities, of the Product recognized as defective by Diabeloop, excluding any indemnity or damages and provided that the Customer notifies Diabeloop of the defect immediately after its discovery by any written means during the legal guarantee. Defective Products will be returned to Diabeloop according to the same procedure as for Products not conforming to the order as described in the above article.

12.8 Diabeloop does not grant any other express or implied warranty, including, but not limited to, the performance and/or durability of the Products and/or the suitability, adequacy and/or conformity of the Products to a particular use or to the needs of the Customer.

12.9 It is the Customer’s responsibility to verify in particular that the characteristics of the Products allow the Products to be used for the purpose and under the conditions for which the Customer intended them. As an essential condition of the sale, it is reminded that the Customer is solely responsible for the use of the Products supplied by Diabeloop and their suitability for the use made of them. The Customer is solely responsible for ensuring that the Products purchased are compatible with other possible Products or materials with which they must be in direct or indirect contact, that they are used in accordance with the rules of the trade, and that they are used under adequate safety conditions. It is also the sole responsibility of the Customer to ensure that the Products comply with the legal safety regulations for the use in question. The Customer shall comply with all laws, regulations and/or directives applicable to the use of the Products. The Customer must also check the integrity of the Products received, their packaging and notices.

12.10 As the Products have a limited lifetime, the Customer is responsible in particular for using the Products before the end of the said lifetime.

12.11 The Customer must make sure that its premises and storage conditions are suitable for the proper conservation of the Products and present the safety guarantees imposed by the regulations in force, Diabeloop’s recommendations and the rules of the trade. No guarantee is provided in this respect by Diabeloop.

12.12 The Customer expressly acknowledges that the use of the Products is under his sole responsibility. No advice or information, whether oral or written, obtained by the Customer is likely to create guarantees not expressly provided for in the GTCs, nor is Diabeloop liable for damages of any kind caused to the Customer or to third parties as a result of the unsuitability, defects or deterioration of the Products, or caused by the Products which result from : 

• storage and/or use of the Products by the Customer that does not comply with the GTC
• natural wear and tear of the Products under normal conditions of use
• products received in unsealed packaging and not returned by the Customer
• abnormal, improper or unsuitable use of the Products or not compatible with the Products
• any direct or indirect contact of the Products with any material, Product or equipment of the Customer
• modification of the Products by the Customer
• negligence, lack of supervision or maintenance of the Products by the Customer
• the re-use of a single-use Product

Such modifications, unsuitability, defects or deterioration are excluded from any warranty. Diabeloop cannot be held responsible for these facts.

12.13 Any liability of Diabeloop is excluded in cases where the specifications possibly provided by the Customer and expressly accepted by Diabeloop contain errors or are not exhaustive.

12.14 Diabeloop shall not be liable for any claims or lawsuits regarding the Products resulting from or relating to advertising, promotion, modifications, misuse or abuse of the Products or other negligence or wrongful conduct on the part of the Customer, its employees, representatives or agents.

12.15 The Customer undertakes to report to Diabeloop, in writing and without delay, any suspicious information that it may receive or identify concerning the Products.

12.16 Diabeloop does not guarantee any indirect and/or immaterial damage whatsoever, such as loss of profit, loss of turnover, loss of data, costs of reconstituting data, damage to image, etc., which could be caused by the Products, whether to the Customer or to any third party. Furthermore, Diabeloop’s liability for any order placed by the Customer will be limited to the amount of this order.

12.17 Diabeloop’s responsibility cannot be engaged in case of non-execution of any of its obligations which would be due to the occurrence of a case of force majeure in the sense of article 1218 of the civil code.

13. Implementation of regulatory obligations relating to medical devices

13.1 The Customer shall fulfill, for the Medical Devices, the obligations of a distributor of medical devices in accordance with the applicable regulations, in particular Article 14 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 concerning medical devices or other European Union harmonization legislation applicable to it. In this respect, the Customer shall verify the drawing up of the declaration of conformity, the presence of the CE marking, the presence of compliant labeling and instructions for use and the presence of the unique device identification system. 

13.2 The Customer guarantees that it has set up a Quality Management System (QMS) as defined in the current international standard ISO 13485 relating to quality management systems for medical devices. It undertakes to implement its QMS for Medical Devices and to maintain its QMS certification, which is an essential obligation. The Customer undertakes to inform Diabeloop as soon as possible in case of any change in the status of its QMS certificate insofar as this change would have an impact on the Medical Devices and in particular, but not limited to, in case of withdrawal, expiry, restriction of the previously certified scope.

13.3 The Customer undertakes to ensure the traceability of the Medical Devices to the users, as defined by Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 or by Directive 93/42/EEC of 14 June 1993 concerning medical devices.

14. Vigilance

14.1 The Customer and Diabeloop undertake to follow the provisions of the guidelines set up by the European authorities, by the Medical Device Coordination Group. The Parties may also refer to the MEDDEV 2.12-1 rev.8 guidelines (“guidelines on the Medical Device Vigilance System”) established by the European Union for material vigilance. 

14.2 The Customer undertakes to inform Diabeloop without delay of any information it may receive on incidents or risks of incidents of material vigilance, occurring after the Products have been placed on the market.

14.3 In this respect, Diabeloop will fulfill its material vigilance obligations towards the authorities by making the necessary declarations, by informing the Customer of any case of material vigilance and by ensuring communication with the competent authorities.

15. Withdrawal or recall of Products

15.1 For the purposes of this article, withdrawal and recall shall be understood in the sense of their definition given by Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 or by Directive 93/42/EEC of 14 June 1993 concerning medical devices .

15.2 The Customer undertakes to have the necessary means at its disposal to carry out a Product recall without undue delay at its own expense, whether this recall is at the request of the local authorities or of Diabeloop.

15.3 The Customer will carry out the withdrawal or recall of the Products in accordance with the instructions given by Diabeloop.

16. Trademarks and intellectual property rights – resale of products

16.1 Diabeloop as well as all the signs and distinctive names on the Products are registered trademarks whose use is not granted to the Customer by the present contract.

16.2 The GTC do not imply any transfer of a patent license or any other industrial property right.

17. Applicable law – Jurisdiction clause

17.1 The GTC shall be governed by French law, to the exclusion of all conflict of laws rules and the United Nations Convention on Contracts for the International Sale of Goods (Vienna, 1980).

17.2 To the extent permitted by applicable law, all disputes relating to the conclusion, interpretation, performance or termination of the Contract shall be subject to the exclusive jurisdiction of the Commercial Court of Grenoble, even in the event of a warranty claim or multiple defendants.

These terms and conditions were last updated in April 2023.