General Terms and Conditions of Business

STANDARD TERMS AND CONDITIONS

of ImplanTec GmbH, Grenzgasse 38a, 2340 Mödling
Valid as at: May 2017

1. Scope

1.1. The following General Terms and Conditions apply to all services that we deliver now and will deliver in future. We do not accept any terms and conditions of the buyer conflicting with, or deviating from, our General Terms and Conditions. Acts of performance on our part therefore shall not be deemed as approval of deviating contractual terms of the buyer.

2. Conclusion of Contract

2.1. Contracts shall take effect only when we have confirmed the order in writing or made a delivery. The contents of contracts, in particular the scope of services, shall be governed exclusively by our order confirmation. Any amendments to contracts shall be subject to our confirmation in writing. Declarations and commitments made by our sales representatives shall not be legally binding for us.

2.2. We reserve the right to change the production or execution of goods.

3.  Prices

3.1. Our prices within Austria shall be indicated in EUROS plus statutory value-added tax and costs of packaging, insurance and transport (in particular in the case of deviating delivery - “express delivery”). At the request and the expense of the buyer we will insure deliveries against theft, breakage, transport, fire and water damage.

3.2. The relevant price shall be the price resulting from the customer price list valid on the day of order confirmation. If goods are delivered without order confirmation, the relevant price shall be the price valid on the date of delivery. All prices shall be based on the cost factors applicable on the date of order and/or order confirmation. If, after such date, material increases of labour or material costs are incurred by us or our suppliers, and if such increases materially increase our purchase prices or prime costs, we shall be entitled to ask for prompt negotiations on price adjustments with the buyer, unless the prices have been confirmed explicitly as fixed prices. Unless agreement is reached within a reasonable period of time, we shall be released from our delivery obligation with regard to outstanding deliveries and shall be entitled to rescind the contract in this respect.

4. Terms of Payment

4.1. Unless other terms of payment have been agreed in writing, the purchase price shall be payable in EUROS, within 7 days of the invoice date without any discount.

4.2. Deduction of discounts from new invoices shall not be permitted as long as older due invoices have not yet, or not fully, been paid. Calculation of discounts shall be based on the net amount minus rebates, freight, and other incidental expenses.

4.3.  After fruitless expiry of a reasonable period of grace, we shall be entitled to perform outstanding services only against prepayment, or to make such services subject to provision of a security, if the buyer delays payment on the agreed terms, or if circumstances arise which, according to customary banking standards, justify doubts about the buyer’s ability to pay.

4.4. If our services are settled by the customer by means of a credit offsetting procedure, we cannot grant any discounts due to the necessary additional auditing and administrative efforts.

4.5. In the event of delayed payment, default interest at a rate of 12% above the relevant base interest rate shall be deemed agreed. We shall be entitled to charge pre-procedural costs, in particular processing costs, dunning fees and lawyer’s fees.

5.  Delivery Periods / Dates

5.1. Delivery periods and dates specified by us shall not be binding and apply only subject to unrestricted availability of the contractual item. Claims for damages for exceeded delivery periods and penalty payments (contractual penalties) for delayed delivery shall be excluded.

5.2. Goods ordered by the customer shall be accepted within the delivery period we have indicated. If the customer fails to accept the goods, we shall be entitled to either deliver the goods and charge the agreed price, or to rescind the contract and charge cancellation fees.

5.3. We assume no liability whatsoever for deliveries which are delayed or not effected due to the fault of our suppliers.

5.4. In the event of unforeseeable circumstances or circumstances beyond the control of a party, such as any and all incidents of force majeure, which prevent compliance with the agreed delivery date, the delivery period shall in any case be extended by the duration of such circumstances, including, but not limited to, delay in customs clearance, transport damage, intervention by authorities, and loss of a major supplier that is hard to replace, or incidents whose effects are similar to the aforementioned examples.

6.  Storage and Use of Sterile Implants

6.1.  Implants should always be stored in their unopened packaging. The packaging of the implants is designed so that they can be stored at normal room temperature / relative humidity  (corresponds with the customary “storage and work climate” in our latitudes, i.e. between approx. +15°C and +35°C, depending on the season, with the respective normal relative humidity) without risking a deterioration of the packaging, sterility of the product, etc. Sterile implants must not be exposed to sunlight without protection (i.e. light protection provided by the outer carton).
The expiry date describes the date specified on the packaging by which the product must be used. It is subject to proper storage that will not influence the condition of the product in terms of quality and effect.

7.  Implants and Instruments on Loan

7.1.  Unless otherwise agreed in writing, implants and instruments requested for short-term loan shall be deemed purchased and invoiced unless returned within 30 days following their delivery.

7.2.  Returned instruments and/or implants showing any damage whatsoever shall be invoiced without exception. This shall apply in particular to any damage or changes to the packaging or labelling.

7.3.  Instruments on loan from us shall be returned in clean and disinfected condition. Written confirmation of cleaning and disinfection on Form FB 10.14 shall be attached to the returned instruments. If instruments are cleaned insufficiently or no such confirmation is attached, cleaning costs in the amount of EUR 250.00 shall be charged to the buyer.

7.4. Costs and risk of transport for returning the instruments shall be at the buyer’s expense.

7.5. The charge for any services associated with the short-term loans shall be EUR 200.00.

8.  Implants and Instruments in the Consignment Store

8.1.  Where agreed, ImplanTec GmbH shall set up a consignment store at the customer’s premises to improve flexibility of delivery, to balance short-term fluctuations in demand, and thus to maintain an optimal supply security for the hospital operations. ImplanTec GmbH shall deliver the specified products to the customer on the basis of an existing master agreement (or delivery contract).

8.2. The stocking level of the consignment store shall be based on the customer’s needs and established by mutual agreement with ImplanTec GmbH. The detailed stocking of this consignment store (in particular product designation, article number, agreed stock quantity) and the respective prices must be stated either in the stock list or separately in the stock list and a separate price list.

8.3. ImplanTec GmbH shall also make the product-specific equipment and instruments that are required for proper recurrent use with the supplied implants available.

8.4. Stocked deliverables as well as equipment and instruments shall jointly be referred to as “consignment goods” and shall be recorded jointly in the stock list and/or list of product-specific instruments.

8.5. ImplanTec GmbH shall stock the deliverables in the consignment store with the objective of thus ensuring 100% supply availability. Thereby the deliverables shall remain the property of the supplier. The customer shall label them reversibly as the property of the supplier, or identify them as such by means of segregation from other items in the consignment store.

8.6. The customer shall make suitable consignment store surfaces available to ImplanTec GmbH free of charge. ImplanTec GmbH undertakes to deliver the goods for the consignment store to the storage location at its own risk and costs, and to hand them over duly and properly there.

The customer undertakes to store the consignment goods properly (adequately protected from outer influences that could impact quality, such as humidity, sunlight and extreme temperatures, as described in Article 6.1).

8.7. ImplanTec GmbH undertakes to have the customer’s staff expected to be using the products (operating staff) in use of the products by technically trained employees of ImplanTec GmbH within the scope of a user training pursuant to the Medical Devices Act, and to draw attention to any hazard potentials and special requirements with regard to handling and storage.

8.8. The customer shall bear the costs of maintenance and possibly IT-assisted internal administration of the store, and for any movements of the consignment goods within the consignment store, as well as the necessary stock maintenance expense (including all expenses necessary for due and proper storage of the goods,. such as in particular refrigeration, where necessary, etc.) for the consignment goods.

8.9. Employees of ImplanTec GmbH shall, by due prior appointment, have access to the consignment store and the consignment goods stored there at any time, inasmuch as this is compatible with the hospital workflow. Thereby the clinical operation must be taken into consideration. ImplanTec GmbH acknowledges that the customer’s treatment areas may only be accessed in compliance with the respective customer’s rules (e.g. hospital rules, house rules, etc.).      

9. Removal, Reporting and Use of Goods from the Consignment Store   

9.1. The goods in the consignment store shall remain the property of ImplanTec GmbH until they are removed from the consignment store. Goods shall be deemed removed as soon as the packaging has been opened, irreversibly labelled, stickered or otherwise damaged.

9.2. The customer shall be entitled to remove the deliverables from the consignment store as required. Essentially, those deliverables with the earliest use-by date should be removed first. Ownership of the goods and thus the risk shall transfer to the customer on removal of a deliverable from the consignment store. ImplanTec GmbH shall be responsible for runtime monitoring (expiry of products). ImplanTec GmbH shall ensure that consignment goods that face expiry and are therefore no longer usable are replaced in good time.

9.3. The customer shall inspect deliveries for completeness and integrity of the containers upon receipt of the delivery. Incomplete deliveries and any defects identified within the scope of this first inspection must be reported to ImplanTec GmbH immediately upon detection. Products that are damaged on delivery shall be replaced with new products by ImplanTec GmbH at no costs for the customer in order to meet the quantities agreed in the stock list.

9.4. ImplanTec GmbH shall invoice the removed and duly reported deliverables to the customer upon removal. The prices and terms of payment shall result from the master agreement (or delivery contract) concluded between the parties.

9.5. Instruments shall be provided with appropriate packing lists, if applicable. The customer undertakes to use the equipment and instruments on loan properly and to care for them in accordance with the written treatment instructions (cleaning and sterilisation instructions) of ImplanTec GmbH.

9.6. Provided goods, such as implants, product-specific instruments and equipment, that are damaged due to improper use shall be repaired by ImplanTec GmbH at the customer’s expense, if economically acceptable, or invoiced to the customer. The same also applies in the event of loss or theft.

10. Obligation of Warranty, Inspection and Reporting of Defects

10.1. Warranty claims of the buyer shall apply only if the buyer has duly met his statutory duty of inspection and reporting of defects. If the goods are obviously defective or incomplete, such complaints must be reported to us in writing within 2 weeks following arrival of the goods at their destination, including a description of the defect and the order and/or invoice number. Defective goods shall be returned to us at our request. If the buyer fails to meet this obligation, the buyer's claims for defective or incomplete delivery shall be excluded. Any and all warranty claims of the buyer shall be fulfilled, at our discretion, either by rectification, provision of the missing parts, or exchange within a reasonable period of time. Only in the event that no rectification, provision of missing parts or exchange occurs within a reasonable period of time for the customer shall the customer be entitled to a price reduction or to rescind the contract (cancellation). Cancellation shall be excluded if only minor defects have occurred.

10.2. We assume no liability for the suitability of our goods for the buyer’s intended purpose,. and the same shall also apply to purely optical deviations not impairing the proper use of the goods.

10.3. Warranty claims must be asserted in court within four weeks from handover of the goods. The period granted shall start on the day of delivery or collection of the goods. We warrant for defects that exist when the goods are handed over.

10.4. Where possible, the customer agrees - or otherwise would lose the claim - to let us study in detail any defects, including inspection and access to documents and the like, to identify occurrence of any such defects. Defects of individual, but independent parts of a delivery/service shall in no event justify rescission of the entire contract and/or cancellation of the entire contract.

11. Damages

11.1. Any claims for damages shall be excluded in the case of minor negligence, which shall not apply to personal injuries.

11.2. In addition, our obligation to pay compensation shall be limited to an amount of 100% of the purchase price. Any compensation for damages beyond such amount shall be excluded in any case.

11.3. Any claim for damages may be asserted in court only within six months after the claimant or claimants have become aware of, or could have become aware of, the damage, but no later than within three years after the event giving rise to the claim. The provisions relating to compensation for damages contained in these General Terms and Conditions or as otherwise agreed shall also apply if the claim for damages is asserted in addition to, or instead of, a warranty claim.

12. General Provisions

12.1. We deliver all goods under a vendor’s lien and goods shall remain our property until full payment has been made, including any additional fees, and until settlement of any current account balance.

12.2. If goods are delivered under vendor’s lien, the customer shall already now assign to us, in lieu of payment, the customer's claims against third parties, insofar as such claims arise from selling or processing our goods, until complete payment of our claim.

12.3. The customer is obliged to inform us about any changes of the customer’s business address as long as the legal transaction has not been completely fulfilled by both parties. Unless such notification is made, declarations shall be deemed received also if they were sent to the address last indicated by the customer.

12.4. Any samples or illustrations and the like, in particular, shall always remain our property. The customer shall not be granted any right of use or exploitation therein whatsoever.

12.5. Should individual provisions of these General Terms and Conditions be, or become, void, ineffective or contestable, the remaining provisions shall be unprejudiced and shall then be construed and/or completed so that the intended economic purpose is attained as precisely as possible in a manner permitted by law. The same shall also apply to any omissions in the contract.

12.6. Austrian law shall apply exclusively. Application of the UN Convention on Contracts for the International Sale of Goods (CISG) is explicitly excluded. The parties agree to Austrian domestic jurisdiction.

12.7. The exclusive legal venue to settle any disputes arising from these General Terms and Conditions and any contracts based thereon shall be the locally competent court in 2700 Wr. Neustadt (Austria).