1. Scope and Validity

1.1
Unless otherwise agreed upon in writing, these General Terms and Conditions of Sales (hereinafter “GTC”) shall govern all aspects of the sale of products and/or the performance of services by EMS to its Customers. In the meaning of the present GTC, a customer shall refer either to (i) a third party distributor or (ii) a public or private healthcare professional / clinic / hospital (the “Customer(s)”).

1.2
The GTC shall form an integral part of the contract between EMS and the Customer. By placing an order with EMS, the Customer confirms that he has read, understood and accepted without restriction the GTC in force on the day of placing such order. This confirmation shall in no way be dependant on a handwritten signature of the Customer.

1.3
Any General Terms and Conditions of the Customer which are contrary to these GTC shall only be binding on EMS if explicitly recognized in writing by EMS.

1.4
EMS reserves the right to amend these GTC at any time, with effect for future transactions with Customers.

2. Conclusion of the contract

2.1
Information provided in catalogues, presentations, and on EMS’ website does not constitute a binding contractual offer. Any quotation sent by EMS to a Customer shall expire thirty (30) days following quotation date, unless specified otherwise in writing.  

2.2
By placing an order, the Customer makes a binding offer to conclude a contract. However, a sale shall only be deemed to be completed either when (i) the order received has been confirmed in writing by EMS, or (ii) EMS has shipped the related products to the Customer, or (iii) EMS has performed the related services for the Customer.

2.3
EMS reserves the right to reject any order received from a Customer, at its sole discretion. EMS shall promptly inform the Customer of its decision to reject an order.

3. Delivery

3.1
All products are delivered FCA Nyon (Incoterms 2020), unless specified otherwise in writing. If required by the Customer, any shipments are made on the account and at the risk of the Customer, which shall be transferred after products’ uploading.  

3.2
The indicated delivery times are approximate and are not binding on EMS. In case the ordered products are unavailable, EMS shall promptly inform the Customer of the delay and provide with new indicative delivery times. EMS shall be granted an additional, reasonable grace period. If the delay makes it unreasonable for the Customer to accept the delivery or service, the Customer may request an order cancellation. In case of cancellation, any amounts already paid towards the purchase price will be refunded immediately. Claims for damages are excluded.

3.3
EMS shall not be liable for any delay or impossibility to deliver for reasons beyond EMS' or its subcontractors’ control, or which are based on force majeure or other events that were not foreseeable at the time of conclusion of the contract and are not within EMS' or its subcontractors’ sphere of influence (such as any act of God, war, strike, lockout, power failure, unforeseeable refusal of official approvals, etc.).

3.4
EMS shall be entitled to make partial deliveries. In this case, the Customer acting as a distributor shall be charged with all individual shipping costs.

3.5
Any damage occurring during transport must be notified to EMS and to the carrier (if relevant), in writing and with no delay, not exceeding five (5) days following reception.

4. Reservation of Title

4.1
The products shall remain the property of EMS until EMS receive full payment of the product price from the Customer, which includes the value of the product and any costs and taxes as indicated in the relevant invoice. 

5. Prices

5.1
Unless specified otherwise in writing, all EMS prices are FCA (Incoterms 2020) excluding taxes (“VAT”) and shipping costs. If product transportation is required by the Customer, any and all transportation costs (including additional packaging, if any) will be additionally invoiced to the Customer.

5.2
The prices stated by EMS at the time of the order and specified in the order confirmation apply.

5.3
All prices for products listed in an offer or otherwise provided by EMS are confidential and may not be disclosed to anyone outside the Customer's organization without EMS’ permission.

6. Payment

6.1
Unless expressly specified otherwise, EMS invoices are payable by bank transfer or direct debit within thirty (30) days of the invoice date. Payment by check or cash are not accepted. EMS reserves the right, at its sole discretion, to require advance payment or letter of credit for deliveries or services not yet performed on individual cases.

6.2
In the event of default of payment or deferral, interest of 5% above the applicable base interest rate may be charged by EMS. In the event of past due balances, EMS reserves the right to refuse new orders and cancel or delay shipment of outstanding orders.

6.3
All orders are payable in the currency specified in the invoice, including all taxes and additional charges if any. All costs incurred in connection with payment shall be borne by the Customer.

6.4
Any payment requiring the establishment of a letter of credit shall be made on an irrevocable document, issued by a bank approved by EMS and indicating the total amount of the open contract. The terms of any such letter of credit shall comply with any specifications or requirements provided by EMS to the Customer. The Customer shall bear and pay full cost, including all banking charges, incurred in connection with the issuance, confirmation, and amendment of each such letter of credit.

6.5
The Customer shall refrain from making deductions of any kind from any payments due to EMS unless a credit memorandum has been issued by EMS to the Customer. EMS is solely entitled to offset payments and will inform the Customer about the type of offsetting that has been made.

6.6
The statutory claims of EMS in the event of payment default by the Customer shall remain unaffected. In the event the device is repossessed due to default of payment, the Customer shall bear all costs associated with the return of the device, including but not limited to costs for dismantling, return transport, cleaning, and, if applicable, refurbishment of the device, in addition to any other claims for damages.

7. Acceptance, Inspection and Notification of Defects

7.1
The Customer shall inspect the products immediately upon receipt to ensure that they comply with the technical specifications.

7.2
Any defects with regard to EMS’ products and services must be reported promptly to EMS in writing as soon as discovered but no later than eight (8) working days after receipt of the products or completion of the services. The notice of defects must be made in writing and must be accompanied by a specific description of the defect. If the Customer fails to report, the products or services are deemed to have been accepted, unless it is a defect that was not recognizable during the inspection. If such a defect later becomes apparent, the Customer must report it immediately after discovery.

8. Returns of Products

8.1
Any return of products requires prior written approval by EMS. The Customer shall send a list of the product(s) to be returned to EMS. EMS will issue a Return Material Authorization (RMA) number. No returns will be accepted without a RMA number and a list of products authorized for return. The RMA number is valid for thirty (30) days from its issuance date. Should the products not be returned during such period, the Customer shall request a new RMA number.

8.2
All returns must be current commercialized products, in original condition and packaging, and not be purchased since more than one year. Any transportation costs shall be borne by the Customer.

8.3
EMS reserves the right to charge the Customer with a repackaging charge, if any is required.

9. Warranty

9.1
All products delivered by EMS pursuant to these GTC shall be free from defects in material and workmanship. EMS reserves the right to make standard deviations or deviations resulting solely from legal requirements or technical improvements, including the replacement of components with equivalent parts, provided that such deviations do not affect the usability of the products for the intended contractual purpose.

9.2
Dental devices and handpieces. Unless otherwise specified in writing, the warranty period for all dental devices and handpieces is:

• for dentalcare professionals: twelve (12) months from installation date;
• for distributors: twelve (12) months from the date of the installation at the end-user’s premises or a maximum of eighteen (18) months from the date of shipment by EMS to the dealer, whichever occurs first.

9.3
Pain Therapy products. Unless otherwise specified in writing, the warranty period is:

• For Pain Therapy devices:
  • for medical professionals: twenty-four (24) months from delivery date;
  • for distributors: twenty-four (24) months from delivery date at the end-user’s premises or a maximum of thirty (30) months from the date of shipment by EMS to the dealer, whichever occurs first.
• For Pain Therapy handpieces:
  • for radial maintenance kit: one (1) million shocks or twenty-four (24) months from delivery date, whichever comes first;
  • for focused handpiece: five (5) million shocks or twenty-four (24) months from delivery date, whichever comes first.
• For Pain Therapy accessories (carts and travel cases): twelve (12) months from delivery date.

9.4
Urology devices. Unless otherwise specified in writing, the warranty period for all urology devices is:

• for LaserClast Thulium Power, LaserClast 35 and Swiss LithoClast Trilogy lines (including Trilogy Wireless Pedal): twenty-four (24) months from delivery date at the end-user’s premises or, a maximum of thirty (30) months from the date of shipment to the reseller, whichever occurs first;
• for all other urology devices: twelve (12) months from delivery date at the end-user’s premises or a maximum of eighteen (18) months from the date of shipment by EMS to the dealer, whichever occurs first;
• for all reusable accessories (excluding sterile products and disposable accessories): twelve (12) months from delivery date at the end-user’s premises or a maximum of eighteen (18) months from the date of shipment by EMS to the dealer, whichever occurs first.

9.5
The Customer shall notify EMS of any complaint with regard to product defects in writing promptly upon such defect has been discovered. Notification must contain all pertinent information, including but not limited to the product reference, batch or serial number, a detailed description of the defect, the date of discovery, any supporting evidence (such as photos), and the impact on the product's functionality or patient safety, if applicable.

9.6
The Customer shall only return the complained products with the express consent of EMS and after prior agreement, according to the provisions of section 8.1 hereto. Any and all costs related to Product transportation shall be borne by EMS, according to EMS instructions. The products shall be shipped from original Customer location, as indicated in the purchase order.

9.7
EMS’ warranty is limited, at EMS’ sole discretion, to either repairing the identified defects or providing a substitute product. The Customer must grant appropriate time and opportunity for this.

9.8
Replacement and repair of any product under warranty, in whole or in part, shall not be deemed to renew or extend the initial warranty period.

9.9
EMS shall not be held responsible under the warranty contained in these GTC and such warranty cannot be claimed for defects, failures or damages caused by:

• Natural causes and weathering, vandalism, loss, theft or attempt of theft;
• Normal wear and tear;
• Improper handling, installation or maintenance other than by EMS;
• Improper use of the Product, meaning - by way of example but not limited to - any use differing from the product intended uses as specified in the IFU;
• unauthorized alterations, modifications or repairs, by persons other than EMS or its authorized repair centers,
• Use of non-original EMS spare parts and accessories,
• Unauthorized resell, transfer or distribution of the products to a third party.

9.10
For the sake of clarity, the warranty cannot be claimed for dental accessories, any consumables, sterile products and disposable accessories, except in case of acknowledged manufacturing defect. Minor and aesthetic defects shall be excluded from warranty obligations.

9.11
Unless expressly specified otherwise by EMS, in the case of the sale of used products warranty claims are excluded. Used products in this context also include goods sold by EMS as refurbished or renewed goods.

10. Installation and Maintenance

10.1
At Customer’s request, EMS or any third party of its choice can perform product installation at the Customer’s premises.

10.2
The Customer shall ensure, at its own expense, that the conditions necessary for proper installation are met (i.e. provision of suitable means of transport from the curb/truck, laying of electricity, water and sewage supply ready for connection). The Customer shall appoint a contact person on site on the agreed installation date, who is competent and entitled to provide binding information about the condition of the premises that is relevant for the installation. In the event of a breach of the above-mentioned obligations, the Customer shall indemnify EMS for any additional expenses incurred.

10.3
The Customer is responsible for ensuring that the device undergoes periodic maintenance work according to the Instructions For Use (IFU) work. Maintenance work shall be performed by EMS or any authorized third party, in accordance with EMS recommendations and applicable standards.

10.4
Maintenance work shall be performed at the Customer’s costs, according to the hourly rates communicated by EMS or any authorized third party.

10.5
By separate agreement and for a separate fee, EMS offers after-sales services, such as separate warranties, repairs or maintenance contracts. These contracts provide a convenient and efficient solution for managing all maintenance and repairs obligations related to the product. The exact conditions result from the separate agreement of the parties.

11. Medical Device Regulations, Traceability

11.1
The Customer acknowledges that the products are medical devices and therefore falling within the scope of the EU council Regulation 2017/745 concerning medical devices and within the scope of any national domestic legislation based thereon. The Customer shall comply with all applicable medical device regulations, standards and traceability requirements.

11.2
The Customer acknowledges and agrees that the end user of the products must be a licensed healthcare professional, or an authorized healthcare entity legally permitted to purchase in accordance with applicable laws and regulations. The Customer shall be responsible to make sure this condition is fulfilled and might be held liable for any failure thereof. Failure to provide such evidence may result in order cancellation, refusal of delivery, or termination of the business relationship.

11.3
The Customer acknowledges and agrees that the products shall be used in accordance with the requirements of the Instructions For Use (IFU).

11.4
 The Customer shall notify EMS in writing of any complaint or incident, without any delay upon such complaint or incident has occurred. Notification with all pertinent information (including but not limited to product reference, batch or serial number, a detailed description of the compliant or incident) shall be sent to the following address: vigilancemailbox@ems-ch.com.

11.5
In the event of a recall, safety notice, or any post-market surveillance requirements, the Customer agrees to provide full cooperation, including timely access to traceability records and implementation of necessary corrective actions as instructed by EMS or competent regulatory authorities.

11.6
In the event the Customer is acting as a healthcare professional, the Customer shall not resell, distribute, or transfer the products to any third party without the prior written consent of EMS and in compliance with all applicable regulations. Any unauthorized resale or distribution shall be considered a material breach of these GTC. In the event of such a breach, the Customer shall be fully liable for any damages, losses, or regulatory consequences arising therefrom and shall indemnify and hold EMS harmless from any claims, penalties, or liabilities resulting from the unauthorized resale or distribution of the products. In such a case, clause 9.9 shall apply.

11.7
In the event the Customer is acting as a distributor, the Customer is responsible for obtaining at its sole expense all applicable governmental or regulatory consents, approvals and authorizations required in the Territory where he wants to sell the Products and necessary for the valid execution of these GTC, unless otherwise expressly agreed upon between the parties.

11.8
The obligations and responsibilities of EMS and the Customer acting as a distributor with regard to regulatory and quality issues are set forth in a separate Regulatory and Quality Agreement, which prevails over these GTC.

12. Intellectual Property

Except as explicitly set out otherwise, nothing in these GTC shall be interpreted as a transfer or assignment to the Customer of EMS’ intellectual property rights. EMS shall remain the exclusive holder of all intellectual property rights pertaining to the Product(s). All representations, plans and other documents generated under these GTC and any contractual provision shall remain with EMS. 

13. Liability

13.1
Except as expressly set forth in this GTC and except to the extent such damages were caused by intentional misconduct or gross negligence, EMS shall not be liable for any special, indirect, consequential or incidental damages, including, but not limited to, loss of actual or anticipated profits or revenues, loss of opportunities, damages arising from commitments in connection with the business, or damages to reputation.

13.2
The above exclusions and limits of liability do not apply in the case of fraudulent concealment of defects and in as far as the exclusions are possible under the applicable legal provisions.

14. Data Protection

EMS and the Customer undertake to comply with the relevant legal provisions regarding data protection, including without limitation the Swiss Federal Act on Data Protection, Regulation (EU) 2016/679 (“GDPR”), and any other local applicable laws thereof. Personal data may only be processed for the purpose and to the extent required for the fulfilment of the contract and for safeguarding a high service and security standard. Personal data shall be collected, stored and shared with third parties only as far as legally admissible and in accordance with applicable data protection laws. The Customer acknowledges and agrees that its personal data may be transferred to other countries, in particular countries in which EMS has an affiliated company, and that such transfers shall be in compliance with applicable data protection regulations. The Customer has the right to access, correct, delete, or object to the processing of its personal data in accordance with the applicable laws. For any questions, comments or requests regarding your personal data, or wish to exercise your rights, please send an email to the following address: privacy@ems-ch.com.

15. Applicable Law and Place of Jurisdiction

15.1
Swiss law shall exclusively apply to the legal relationship between EMS and the Customer. The application of the provisions of the United Nations Convention on Contracts for the International Sales of Goods (Vienne Convention 1980, CISG) and the international private law is expressly excluded.

15.2
All disputes arising from the present GTC or the underlying agreement or in connection thereof shall be subject to the competent courts of Lausanne, Switzerland.

15.3
These GTC are edited in various languages. In case of conflict between the various languages the version in English language shall be the decisive edition.

Ernst Wühr
General Manager

Héloïse Deliquiet 
Head of Legal & IP 

Version: 19 March 2025

E.M.S. Electro Medical Systems S.A.
Ch. de la Vuarpillière 31
CH-1260 Nyon