GENERAL TERMS AND CONDITIONS OF SALE OF PRODUCTS
of Iskra Medical d.o.o. (hereinafter”Iskra Medical”)
1.1. Unless otherwise agreed in writing, these General Terms and Conditions (hereinafter: “Terms and
Conditions”) shall apply to all purchases of Iskra Medical product either to Distributors or End
Customers (hereinafter “Distributor”).
1.2. These Terms and Conditions shall apply to all business transactions between Iskra Medical and
Distributor regardless of whether they are referenced in future purchase orders or order
acknowledgements. The applicability between the parties of any general terms and conditions adopted
by the Distributor is explicitly excluded. By placing a purchase order, the Distributor explicitly agrees
to the Terms and Conditions.
1.3. Departures from these Terms and Conditions only apply if explicitly agreed in writing. Such
departures have no effect on other existing/future agreements.
1.4. Iskra Medical is entitled to amend these Terms and Conditions at any time.
1.5 Iskra Medical and the Distributor may sign and additional Distribution agreement, with more
2. Sales Orders
2.1. The Distributor shall place orders for the products with Iskra Medical in writing, directly (orally) at
the representatives of Iskra Medical or by telephone.
2.2. Purchase orders are non-binding on Iskra Medical unless and until confirmed in writing by Iskra
Medical or Iskra Medical ships the products included in the purchase order. Iskra Medical may (in its
sole discretion) refuse acceptance of any order.
2.3. The Distributor is bound to its purchase order for two (2) weeks unless withdrawn earlier by
written notice to Iskra Medical, provided that Distributor cannot withdraw a purchase order for which
Iskra Medical has already shipped the products included therein.
2.4. All orders are subject to availability. The silence of Iskra Medical with regard to offers, purchase
orders, requests or other declarations of the Distributor shall not imply consent or agreement unless
expressly agreed otherwise in writing.
2.5. If any individual purchase order is unilaterally annulled by Distributor or a purchase order or partial
purchase order unilaterally cancelled by the Distributor, the Distributor shall reimburse Iskra Medical
all costs resulting from annulment or cancellation of such purchase order (“Basic Reimbursement”). If
purchase order is annulled or cancelled upon expiry of 5 days from the delivery of purchase order to
Iskra Medical, in addition to the Basic Reimbursement the Distributor shall also pay to Iskra Medical
cancellation fee in amount of 20% net worth of cancelled purchase order.
3. Product Information
3.1. Catalogues, brochures and price lists are intended for general guidance only and do not form part
of any contract.2
3.2. The obtaining of any legal authorisation, permits or similar for further sale of the product by
Distributor at the agreed territory of distribution shall not be responsibility of Iskra Medical.
4.1. Iskra Medical’s liability for defects in products shall be limited to the terms of this guarantee.
4.2. Iskra Medical shall not be liable for defects due to natural tear and wear, damage in transport,
faulty use, storage or any other circumstances beyond Iskra Medical’s immediate control.
4.3. The rights of the Distributor with regard to defects shall be subject to Distributor examining the
delivered products upon receipt and notifying Iskra Medical in writing on any defect immediately after
4.4. Hidden defects shall be notified to Iskra Medical in writing immediately after their discovery.
4.5. Iskra Medical shall not be liable for any defects that show themselves more than 12 months after
the products have been delivered, unless a longer period is explicitly stipulated between parties.4.6.
Iskra Medical’s liability for defects shall also not apply to any products if security labels/security seals
have been in any way damaged or removed from the products.
5.1. Unless agreed otherwise, all prices stated in an offer or agreement are in euros. The prices are
exclusive of taxes and other levies.
5.2. Unless otherwise specified by Iskra Medical, all prices apply for FCA delivery at Iskra Medical’s
storage in Ljubljana in accordance with the Incoterms 2010.
5.3. Iskra Medical reserves the right to increase any agreed prices in the event of increases in valueadded tax, customs duties or other public charges or because of the changes in the exchange rate for
the currency in which the prices have been determined.
5.4. Extra costs as a result of changes to the order following confirmation of the order are payable by
Distributor. The delivery date may also be changed in such cases.
6.1. The Distributor must pay the agreed price, the taxes and other levies within the period stipulated
by Iskra Medical.
6.2. Unless agreed otherwise, all payments must be made in advance. Payments must be made into
bank account indicated by Iskra Medical.
6.3. The Distributor agrees to settle Iskra Medical’s invoice in full without any deductions or set-offs.
7. Delayed Payment
7.1 If Iskra Medical and Distributor agreed on payment after delivery and payment of any Iskra
Medical’s invoices is overdue, Iskra Medical may partly or fully suspend the contract to which the
invoice relates and any other contract then subsisting between Iskra Medical and the Distributor. Iskra
Medical may suspend all deliveries under the contract to which the invoice relates as well as under any
other contractual relationship between the parties. No deliveries will take place if any invoices are
7.2. Interest on overdue amounts shall accrue without notice at the statutory rate determined by laws
of Republic of Slovenija.
7.3. The Distributor will be liable for all reasonably incurred judicial and extrajudicial collection costs,
including the costs of proceedings as well as the costs of lawyers and third parties engaged by them.,
which Iskra Medical incurs as a result of Distributor’s failure to fulfil its payment obligations.
7.4. Payments made by Distributor first serve as payment of any costs and interest owed, and secondly
as payment of the oldest due and payable invoices.
8. Delivery of Products
8.1. Iskra Medical will deliver product in such packages and in minimum quantities determined by Iskra
8.2. Iskra Medical is entitled to make partial deliveries in order to perform its contractual obligations
unless partial delivery is not acceptable for the Distributor and the Distributor has referred to this fact
in its purchase order.
8.3. All deliveries are made FCA Ljubljana (Incoterms 2010) at the production or distribution site
specified by Iskra Medical.
8.4. Return of the products shall only be made with the prior written consent of Iskra Medical and
Distributor must comply with all instructions of Iskra Medical with regard to the return of the products.
8.5. The Distributor shall comply with all applicable national and/or international laws, rules and
regulations concerning waste, waste disposal and recycling of waste, and environmental hazards
especially but not limited to: waste electrical and electronic equipment (WEEE), packaging and
packaging waste and medical waste. The Distributor will before first/every advertising and/or putting
the device on the market ensure that the device and its packaging is register in any/all national waste
disposal registry and pay the appropriate dues connected to the waste disposal, and take all measures
that all the waste connected with the device will be disposed in accordance to the national law. The
Distributor will pay all dues, taxes, penalties, court and legal costs connected to waste disposal of the
device and waste connected to the device. This obligation must be fulfilled at least 8 years after sale
of each Device.
9. Liability for Delay
9.1. Iskra Medical shall be liable for delays in delivery only if, and to extent that, all of the following
conditions are fulfilled:
(i) a fixed delivery date has been expressly agreed upon in writing between the parties,
(ii) the delay exceeds the agreed date with a minimum of three (3) weeks, and
(iii) it is established that the delay is caused by Iskra Medical’s negligence.
9.2. Damages, if any, payable for the Distributor for delays in the delivery of the products according to
the above shall be equal to the losses sustained by the Distributor. However, total amount of such
damages shall in no event exceed 5% of the net price of the delayed portion of the delivery. For the
purpose of this provision, net price as agreed for the sale from Iskra Medical to Distributor is applicable.
10. Inspection of records, translation of documents and traceability4
10.1. Distributor shall keep accurate records of all its activities as reasonably necessary to determine
its compliance to the Terms and Conditions, including accounting records, customer sales records and
governmental filings. Distributor shall retain such records for at least a 3-year period following their
creation or preparation. For a period of 18 months after the purchase of the product, Iskra Medical
shall have the right to inspect and audit such records.
10.2. Iskra Medical shall provide to Distributor documents concerning products in English. Distributor
shall translate and verify documents to the language of Territory at its own expense. All translation of
documents must be authorized by Iskra Medical in writing. Use of non-authorized translations of the
documents is not allowed.
10.3 The Distributor shall market the Products only in the form as received from the Manufacturer,
and as required by any regulatory authorities in the Territory. The distributor shall not alter or modify
any Product or misuse any trade or service mark of the Manufacturer or its subsidiaries (collectively
10.4 Distributor shall obtain, at its own expense, all approvals, certifications, permits and licenses
(collectively “Approvals”) that may be necessary to import, sale and use the Products in the Territory.
The Distributor shall comply with any regulatory and safety requirements of the authorities in the
Territory. Manufacturer shall not be obligated to deliver any Products unless and until Distributor
provides Manufacturer with satisfactory evidence that such Approvals have been obtained.
10.5 The Distributor shall notify of all reportable (adverse) events to the bodies designated by the state
in the Territory. A copy of such report must be submitted to the Manufacturer within 72 hours by
telephone, fax, e-mail or in-person. The same obligation applies to the Manufacturer if the
Manufacturer receives information on adverse events regarding Products sold within the Territory.
This obligation must be fulfilled at least 8 years after sale of each specific Product.
10.6 If the Manufacturer decides to perform a preventive or corrective action on a device sold to the
Distributor, the Distributor shall follow all the instructions received from the Manufacturer at
Manufacturer’s expense. In such case the Distributor is requested to submit the periodic preventive or
corrective action status reports to the Manufacturer so that the Manufacturer may access the progress
of the preventive or the corrective action. It is Manufacturer’s responsibility to report the corrective
action to the competent authority for adverse event reporting and report the notified body (if required
by law). This obligation must be fulfilled at least 8 years after sale of each specific Product.
10.7 The Distributor shall comply with all applicable national and/or international laws, rules and
regulations concerning medical devices, including but not limited to the Medical Devices Directive
(Council Directive 93/42/EEC), Regulation (EU) 2017/745 of the European Parliament and of the
Council of 5 April 2017 on medical devices (Medical Device Regulation) and respective guidelines of
the European Commission. This obligation must be fulfilled at least 8 years after sale of each specific
10.8 The Distributor is obliged to guarantee traceability of sold the product at all times in case of
performing a preventive or corrective actions. The Distributor shall follow all the instructions received
from the Manufacturer. This obligation must be fulfilled at least 8 years after sale of each specific
10.9 Both parties agree upon traceability for the medical systems and equipment, which are being
manufactured by Manufacturer. The Distributor must grant access of the traceability data to the5
Manufacturer immediately and free of charge. Traceability of each Product must be ensured at least 8
years after sale of this specific Product
10.10 The Distributor may not remove references to Iskra Medical as manufacturer or other references
or instructions for use or serial numbers or distribute Products without such references and
instructions for use.
11. Risk and Title
11.1. The Distributor bears all risks of loss of or damage to the products from the time they have been
placed at his disposal at the named place of delivery on the date or within the period stipulated or, if
no such place or time is stipulated, at the usual place and time for delivery of such product, provided,
that the goods have been duly appropriated to the contract, that is to say, clearly set aside or otherwise
identified as the contract goods.
11.2. Title to and ownership of the products shall pass to the Distributor only upon Iskra Medical’s
receipt of all payments due to Iskra Medical for the products delivered. In case of advanced payment,
title to and ownership of the product shall pass to Distributor when they have been placed at his
disposal at the named place of delivery on the date or within the period stipulated or, if no such place
or time is stipulated, at the usual place and time for delivery of such product.
11.3. The Distributor shall not be entitled to pledge or in any way charge by way of security for any
indebtness any of the products that remain the property of Iskra Medical.
12. Disclosure of documents and information
12.1. Distributor may not reject Iskra Medical's claim to provide Iskra Medical upon first request with
any documentation, information or data required by Iskra Medical with regard to warranty claims,
compensation claims or any other claims against Iskra Medical arising out of or in connection of the
products sold by the Iskra Medical. Upon Iskra Medical’s request, The Distributor shall disclose
documentation, information or data required directly to Iskra Medical or any other person authorized
by Iskra Medical (e.g. insurance company, licensed attorney ..). Distributor may also not prevent Iskra
Medical to disclose documentation, information or data in Iskra Medical’s possession in any
proceedings conducted to assert claims against Iskra Medical, for the purpose of defence against such
13. Intellectual Property Rights
13.1. The Distributor acknowledges that all trademarks, trade names, patents, industrial designs and
other intellectual property, whether registered or not, as well as Iskra Medical’s know-how, relating to
the products or provided by Iskra Medical are and shall remain the exclusive property of Iskra Medical
and shall not be used, distributed, licensed, disclosed or registered by Distributor without prior written
consent from Iskra Medical.
14. Relationship of contracting parties
14.1. Distributor is an independent contractor and not an employee, agent, affiliate, partner or joint
venture with or of Iskra Medical. Neither Distributor nor Iskra Medical shall have any right to enter into
any contracts or commitments in the name of, or on behalf of the other or to bind the other in any
respect whatsoever, unless otherwise agreed between the parties.6
14.2. Distributor shall have no right to assign any of its rights or delegate its obligations under this
Agreement without the prior written consent of Iskra Medical. Any assignment or delegation
attempted without such written consent shall be void and of no legal effect whatsoever.
15.1. The Distributor shall not use or disclose any of Iskra Medical’s trade secrets or know-how relating
to the products.
15.2. The Distributor shall use confidential information exclusively for the purposes of these Terms and
Conditions or sales contracts and shall not disclose it to anyone. The Distributor shall hold all
confidential information with no less degree as is used for his own confidential information and at least
with reasonable care.
16. Force Majeure
16.1. Iskra Medical shall not be held liable for any failure to perform caused by reason of force majeure
events or other circumstances beyond Iskra Medical’s control such as (but not limited to) industrial or
labour disputes, riots, fires, floods, wars, embargoes, epidemic, shortage of labour, raw material,
energy, means of transportation or for circumstances caused by reason of laws, regulations, orders or
acts of any government or authority.
17. General Limitations of Liability
17.1. The liability, if any, of Iskra Medical for any damages shall always be limited to an amount equal
to the price paid by Distributor for the product to which the damage relates. Iskra Medical shall in no
event be liable for any special, incidental, indirect or consequential losses or damages such as loss of
profits, loss of contract, damage to property, loss of use, purchase in replacement or liabilities to third
17.2. All claims for liability under distributor agreements expire if not properly lodged against Iskra
Medical within twelve (12) months from the moment the liability arises. Mandatory statutory liabilities
shall remain unaffected.
18.1. In the event of Distributor failing to fulfil completely, properly and on time any obligation arising
from these Terms and Conditions or sales agreement, the Distributor will be in default, without any
notice of default being required, and Iskra Medical will be entitled, without being obliged to pay
compensation of any kind and without detriment to its further rights, to suspend with immediate effect
and without judicial intervention, the performance of all its obligations and/or entirely or partially
terminate or cancel the agreement concerned. In such a case, Iskra Medical will also be entitled to
demand payment at once for any amounts which the Distributor owes Iskra Medical.
18.2. In the event of termination by Iskra Medical, at its discretion Iskra Medical may opt for
compensation in the form of:
(i) any adverse difference between the contract price and the market value of the goods concerned on
the date of non-performance, or7
(ii) the difference between the contract price and the price of covering sale;
without this affecting the right of Iskra Medical to additional or alternative compensation.
18.3. Moreover, without being obliged to pay compensation of any kind, and without detriment to its
further rights, Iskra Medical will be entitled, with immediate effect and without judicial intervention,
to terminate agreement with the Distributor, if:
(i) the Distributor becomes insolvent or bankrupt or enters into rearrangement of the debts, or this is
impending, or if any part of its assets is subject to attachment;
(ii) the Distributor ceases its operations, or enters into liquidation, otherwise loses its legal personality
or transfers or merges its business;
without this affecting the right of Iskra Medical to additional or alternative compensation.
Iskra Medical will have the right to terminate any contract for convenience (i.e., without cause) upon
30 days prior written notice to the other contracting Party. For the purposes of clarity, it is the
understanding of the Parties that during the notice period described above, the rights and obligations
of the Parties shall continue in full force and effect until the applicable date of termination of the
18.3 If there is no sale of Products from Iskra Medical to the Distributor with written acceptance of the
order within time period of 6 months, this Terms and Conditions are automatically expired with expiry
of the last day of 6 months period from the last confirmed order.
18.4 In case of termination or expiration of Terms and Conditions and/or any contract between Iskra
Medical and Distributor, all rights and obligations of contracting Parties related to the requirements of
the EU Medical Device Directive (MDD) and/or other applicable national regulations (including but not
limited to Clause 10: (Inspection of records, translation of documents and traceability), Clause 12
(Disclosure of documents and information), and additionally Clause 6 (Payments), Clause 15:
(Confidentiality), Clause 19: (Applicable Law) and Clause 20: (Jurisdiction)) shall survive such
Termination or expiration.
18.5 Iskra Medical may decide to accept individual orders from the Distributor and to deliver the
ordered Products or any other products after the Termination or Expiration of this Terms and
Conditions and/or Distribution Agreement. For such deliveries, all rights and obligations of Iskra
Medical and Distributor from these Terms and Conditions and/or Distribution Agreement which are
related to the requirements of the EU MDD and/or other applicable national regulations (including but
not limited to Clause 10: (Inspection of records, translation of documents and traceability), Clause 12
(Disclosure of documents and information), and additionally Clause 6 (Payments), Clause 19:
(Applicable Law) and Clause 20: (Jurisdiction)) shall apply.
19. Applicable Law
19.1. These Terms and Conditions and any sales contracts shall be governed by and constructed in
accordance with the law of Republic of Slovenija.
20.1. Unless prevented by the mandatory law, any disputes arising out of or in connection with these
Terms and Conditions and/or any sales contract will be settled by the court in Republic of Slovenija,
without detriment to the right of Iskra Medical to institute legal proceedings against the buyer in a
court which has jurisdiction in other respects.8
21. Written Form
21.1. Whenever a notice, acceptance, consent or any other communication is required to be in writing
according to these Terms and Conditions, this requirement shall be fulfilled also when such
communication is given or made by facsimile or electronic mail.
22. Different Language Versions
22.1. If there is any discrepancy between two language versions of the Terms and Conditions, the
English version prevails.
23.1. Iskra Medical may assign its liabilities under these Terms and Conditions to any of its subsidiaries,
affiliated companies, branches, other companies which belong to the same group of companies,
distributors and agents.
23.2. The Distributor may not assign its liabilities under these Terms and Conditions to any third party
without prior written consent from Iskra Medical.
24.1. If any provision of these Terms and Conditions is held to be invalid or unenforceable, it shall be
deemed to be severed from these Terms and Conditions and shall not affect the validity or
enforcement of the remaining provisions of these Terms and Conditions.
GENERAL TERMS AND CONDITIONS OF SALE OF PRODUCTS v1.3 valid from 10.01.2020