General Terms and Conditions
General Terms of Sale
General – Scope
Our terms of sale are applicable exclusively; terms conflicting with or deviating from our terms of sale on the part of the purchaser shall not become an integral part of the contract unless we expressly agree to their application in writing. Our terms of sale shall also apply, in particular if we know of conflicting terms or terms deviating from our terms of sale on the part of the purchaser and execute a delivery to a purchaser without reservations.
All agreements reached between us and the purchaser for the purpose of executing the contract shall be put into writing in the contract. Deviations, additional stipulations and oral agreements as well as agreements with traveling salesmen, representatives and agents shall require our written confirmation in order to become valid. This shall also apply to a waiver of the written form requirement.
Our terms of sale shall also apply to all future transactions with the purchaser.
Contract Conclusion – Documents
Our offers are subject to change and non-binding.
The contract become binding only with our order confirmation, at the latest, however, upon execution of our contractually owed performance. Our delivery note shall also be valid as an order confirmation.
We reserve ownership and copyrights to images, drawings, calculations and other documents. They shall be kept secret in relation to third parties and shall not be made available to third parties without our express written consent.
Prices – Terms of Payment
Unless otherwise stipulated in writing, our prices for goods shipped outside of Germany are quoted "ex works" (INCOTERMS 2018) plus the statutory VAT applicable on the day of invoicing. For shipments within Germany, cost of shipping is paid by us, provided that the total invoice amount is Two Hundred Euros (€200.00) or more. There will be an Eight Euro (€8.00) charge for all shipments with an invoice value less than Two Hundred Euros (€200.00).
For all Domestic Orders: If not otherwise agreed, the purchase price shall be payable net (without deduction) within 30 days upon receipt of the invoice. If payment is made within 14 days upon receipt of the invoice, we grant a discount of 2% from the invoiced amount.
For all International Orders: If not otherwise agreed, the purchase price shall be made in advance of shipment.
No discount may be deducted from new invoices if older invoices are still open for payment. If the purchaser is in default of payment, we shall be entitled to charge interest for default amounting to 8 percentage points above the annual basic interest rate. If we are able to prove a higher damage caused by default we shall be entitled to claim same.
The purchaser shall have set-off rights only if its counterclaims have been legally established, are undisputed or recognized by us. It shall also be entitled to exercise a right of retention insofar as its counterclaim is based on the same contractual relationship.
Delivery dates – unless otherwise agreed in writing – shall be nonbinding.
The delivery period shall commence on the day of receipt of the order, however, not before all questions relevant for the execution of the order have been clarified.
The delivery period shall be deemed to have been observed if the goods have left the factory by its end, or the information been given that the goods are ready for dispatch.
In case of force majeure or other unforeseeable circumstances for which we are not responsible, – e. g. labor dispute actions, business disruptions, energy supply disruptions and disruptions in the supply of raw and other materials, disruptions in transportation, or official measures – the delivery periods will be extended in a reasonable scope if we have been prevented from fulfilling our obligations in due time. If, due to the stated circumstances the delivery becomes definitely impossible or unacceptable, we shall be freed from our delivery commitment. If the delay in delivery lasts longer than four weeks, both parties shall be entitled to withdraw from that portion of the contract which has not been fulfilled yet. If the delivery period is extended or we are freed from the delivery obligation due to the circumstances stated above, the purchaser shall not be entitled to deduce any claims for damages from this. We may only refer to said circumstances if we informed the purchaser immediately. Our delivery times are subject to correct and timely delivery by our suppliers.
Transfer of Risk – Packaging Costs
If not otherwise expressly agreed, delivery shall occur "ex works" (INCOTERMS 2018).
On request of the purchaser, we will procure transport insurance for delivery. All costs arising in this connection shall be borne by the purchaser.
In particular, any express costs incurred shall be independent of the value unfree. No credit note is issued for the difference between freight and express freight costs.
Rights Relating to Defects – Return of Goods
The purchaser may not refer to statements made by us, or – if we are not the producer – made by the producer or its subsidiaries, if we did not know or did not have to know the statement, if the statement, at the time of conclusion of the contract, had been amended in an equivalent manner, or if the statements could not influence the purchaser's purchase decision.
The purchaser shall bear the burden of proof with respect to the circumstances specified in this Clause 1.
Purchaser shall notify obvious defects to us within three days after receipt of the goods. If the purchaser fails to notify us in due time this shall be considered acceptance of the goods without reservations.
In addition, the purchaser shall inspect the goods immediately after receipt and notify us in writing of possible claims within three days after the defect has been detected. If the purchaser fails to make a notification this shall be considered as an acceptance without reservations.
A warranty for hidden defects, which could not be discovered despite careful examination shall be excluded if these are not reported in writing by the purchaser within three days of detection.
At our discretion, we may remedy any defect or deliver goods free of defects. We bear all expenses necessary for remedy or new delivery, in particular the costs for transportation, travel, work, and material. We shall not be obliged to bear the transportation, travel, work and material costs if these arise due to the fact that the purchased items have been brought to a place other than the place of performance.
The assumption of a warranty explicitly requires a corresponding agreement. Precise descriptions of the goods and its designated use alone do not constitute a warranty.
All claims based on a defect shall lapse within one year upon delivery of the object. This shall not apply in case of a deliberate breach of duty and/or for damage claims and/or claims for reimbursement of expenses.
Goods that were delivered properly will only be taken back after we have given our consent. The goods must be in their original packaging and in a resalable condition. Goods of which the use-by date has expired or which are damaged Or are sterile packaged cannot be taken back. Returns will be credited on the basis of the invoice price with a deduction.
Custom-made products and articles which have been specially ordered for the customer or which are not part of Key Surgical's standard delivery programme are generally excluded from return as a gesture of goodwill. The same applies to sterile products in accordance with the Medical Devices Act.
Key Surgical is entitled to charge a fee of 10% of the sales price, but at least € 50.00, for the costs of taking back the goods, which is deducted directly from the value of the goods to be credited.
All returns of goods shall be made via the competent customer service, stating the following details:
Reason for return
Original invoice and delivery addresses
Original order number
Pick-up address for the return
Possible specifics to be considered upon pick-up
The customer service personnel registers the request for return, agrees on a date for the pick-up of the goods and arranges for possible credit notes.
Unless otherwise stipulated above, our liability for all rights and claims resulting from and in connection with this contract, whether contractual or non-contractual, shall be limited as follows,:
to damage from injury to life, limb or health resulting from a deliberate or negligent breach of duty by us, our legal representatives or our vicarious agents;
to other damage based on a deliberate or grossly negligent breach of duty by us, our legal representatives or our vicarious agents;
if a defect was fraudulently concealed or a warranty assumed regarding the quality of an object;
to damage claims under the product liability law.
Any further liability on our part shall be excluded.
Reservation of Title
We reserve ownership of the goods until all claims from the delivery contract have been fully paid.
Until the transfer of ownership, the purchaser shall handle the goods with care; the purchaser shall in particular be obliged to insure same sufficiently at its own cost against damage caused by fire, water or theft at the replacement value and to provide evidence that it has taken out such insurance policies. Should maintenance and inspection works be necessary, those shall be carried by the purchaser at its own cost.
In case of seizure or other interference by third parties, the purchaser shall inform us immediately in writing. To the extent a third party is unable to reimburse us for the costs, in and out of court, of a legal action against such third party, the purchaser shall be liable for the loss incurred by us.
The purchaser is entitled to resell the goods in the ordinary course of business, however, already at this point in time, purchaser shall assign to us all claims in the amount of the final invoice amount (incl. VAT) of our claim which accrue to it from the resale to its customers or third parties. We hereby accept the assignment. The purchaser shall be entitled to collect such claim even after the assignment. This shall not affect our entitlement to collect the claim ourselves. However, we undertake not to collect the claim as long as the purchaser meets its payment obligations from the proceeds received, is not in default of payment, and, in particular, no application for the institution of insolvency proceedings has been filed and there is no suspension of payments. Should this, however, be the case, we can demand that the purchaser disclose to us the assigned claims and their debtors, give all information necessary for collection, surrender the relevant documents and inform the debtors (third parties) of the assignment.
Reprocessing or Multiple Use of Single-Use Products
Our products marked as single-use products are not suitable for reprocessing and multiple use in clinics. We are therefore not liable for such defects which result from the reprocessing and/or the multiple use of our single-use products. This applies in particular to possible functional impairments of the single-use products caused by the reprocessing and multiple use.
If the purchaser itself or through third parties has reprocessed products which were marked as single-use products – in particular resterilized same – and/or the purchaser has used single-use products several times in a clinic and third parties assert claims against us, in particular product liability claims, which result from the fact that the single-use product was reprocessed by the purchaser and/or used several times, the purchaser, upon the first written demand, shall indemnify us from these possible claims of third parties, in particular possible product liability claims, and reimburse us for the costs for legal defense.
Compliance with Laws and Ethical Codes
The purchaser shall commit itself to comply with all applicable legal provisions and official directives in connection with the performance of the contract as well as the use, resale, marketing, distribution and the export of our products. The purchaser, when making the device available on the market, shall comply with the general obligations of distributors in accordance with Article 14 of Medical Device Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017. Further, the purchaser shall commit itself to comply with the statutory provisions against corruption and bribery as well as the statutory provisions on the cooperation with hospitals and other medical facilities, physicians, pharmacists and other health care professionals (including the legal provisions for the medical profession, the competition law, the public service law, the social security law as well as the applicable criminal law) including the provisions on illegal gratuities to office holders.
The purchaser shall confirm that it knows the contents of the ethical codes and the codes of conduct of the recognized initiatives of the medical products industry. These include European Diagnostic Manufacturers Association (EDMA) and the European Medical Technology Industry (Eucomed) and the Medtech Guidelines on Interaction with Health Care Professionals. The purchaser shall commit itself to comply with these ethical codes and codes of conduct in connection with the performance of the purchasing contract as well as the use, resale, marketing, distribution and export of our products.
The purchaser shall commit itself not to bestow on third parties any inadmissible considerations, gifts or other economic advantages in connection with the distribution, marketing or resale of our products. This shall particularly apply to the cooperation with office holders, hospitals, medical facilities, physicians and other health care professionals.
The purchaser shall make sure that all its employees, representatives and vicarious or other agents are familiar with the legal and ethical rules stipulated in Clauses 1 through 3 above and follow same in connection with our products.
The purchaser shall inform us immediately of any violations of the obligations stipulated in Clauses 1 through 4 above insofar as the violation gives rise to claims by third parties against us, results in the initiation of official or judicial proceedings against us or threaten to otherwise impair our interests considerably.
If the purchaser negligently violates any of the obligations stipulated in Clauses 1 through 5 above, it shall be obliged to compensate us for the resulting damage.
Information on the processing and application possibilities of our products, technical advice and other data are given to the best of our knowledge, however, nonbinding, to the exclusion of any liability.
In case of modification of the products purchased from us – in particular with regard to their labeling and/or their sterile and storage packaging – through the purchaser or another third party, we shall not assume any liability.
It shall be the purchaser's responsibility that the storage facilities for our products are clean and that the storage temperatures specified on the product labeling are followed. To the extent that no particular storage conditions are specified, the products are not permanently below 10°C or above 30°C and that the relative humidity does not exceed 90%.
The purchaser shall ensure traceability of the products and for this purpose set up and maintain a system which guarantees the immediate identification of the recipient of a product, based on the purchaser's records regarding code number, quantity, delivery date and batch number / LOT, in order to be able to carry out corrective measures relating to certain products according to our instructions or the instructions of the competent authorities. The purchaser must maintain these records for ten (10) years from the date of sale by purchaser. At the end of the purchaser’s retention period, purchaser must obtain from us in writing the disposition of any related records of distribution, recalls, complaints, and customer notifications.
If selling outside of the EU/EEA, purchaser shall be responsible for preparing and filing all product approvals or registrations necessary to sell the products in the territory. All fees required for products registrations will be the responsibility of the purchaser. We will cooperate and assist purchaser in organizing technical information about the products in order to meet any regulatory requirements. A copy of each product approval or registration shall be forwarded to our Regulatory Department.
Purchaser will provide the following information to seller by telephone, fax, or email as soon as practical (i) customer feedback relevant to safety and performance of the product (ii) any customer expression of dissatisfaction with the products, documentation or service, any adverse events potentially related to the products, serious adverse events must be reported to us and our Authorized Representative (where applicable) within 24 hours.
By using communicating with us electronically, you consent to our collection and subsequent use of your personal data for our legitimate business uses. If you do not consent to such collection or subsequent use of your personal data, you may not be able to communicate electronically with us.
Venue – Place of Performance – Data Protection
If the purchaser is a merchant, a legal entity under public law, or a special fund under public law, our place of business shall be the venue; however, we are entitled to sue the purchaser also at its place of residence and/or its place of business.
Unless otherwise agreed, our place of business shall be the place of performance.
For these terms of business and all privity of contract between us and the purchaser the laws of Germany shall exclusively apply. The application of the CISG shall be excluded.