General terms and conditions of sale and delivery

PSM Medical GmbH

The following terms and conditions shall apply to all our sales, deliveries and offers, provided that the customer is an entrepreneur within the meaning of the German Civil Code (BGB) and unless otherwise agreed in writing. The customer’s terms and conditions shall only apply if and to the extent that we expressly agree to them in writing.

1. Offer and conclusion of contract

1.1 Our offers are subject to change and are to be understood merely as an invitation to place an order.

1.2 Contracts shall only be concluded upon our written confirmation (“Order Confirmation”). Our order confirmation shall be decisive for the scope of delivery. In the case of custom-made products, the contract shall only be concluded upon written confirmation by the Purchaser.

1.3 Subsidiary agreements and/or amendments require written confirmation by us.

2. Prices

All prices are ex works Tuttlingen plus applicable sales tax, plus packaging and transport. For sales to end customers, we deliver free of charge from a net order total of € 250, otherwise plus packaging and transport costs.

3. Payment

3.1 Our invoices are payable within 14 days without deduction, in each case from the date of invoice.

3.2 Payments in bank transactions shall only be deemed made to the extent that we can freely dispose of them at a bank. Invoice settlement by check is only possible with our prior consent. Bills of exchange are not accepted.

3.3 The statutory default rules shall apply, also with regard to the default interest. The assertion of further damage caused by default remains unaffected.

3.4 The Purchaser shall only be entitled to set-off rights if its counterclaims have been legally established, are undisputed or have been acknowledged by us. The customer shall also have no right of retention due to disputed counterclaims.

3.5 If justified doubts arise as to the solvency of the Customer or if insolvency proceedings are applied for with regard to its assets, all claims arising from the business relationship shall become due immediately. In addition, we are entitled to demand advance payment, payment on delivery or the provision of security.

4. Delivery times and delay in delivery

4.1 Dates for our deliveries shall only be binding if we expressly confirm them in writing. The delivery period begins with the dispatch of the order confirmation.

4.2 The delivery period shall be deemed to have been complied with if the delivery item has left our works or notification of readiness for dispatch has been given by the time the delivery period expires.

4.3 Force majeure, operational disruptions, strikes or other hindrances for which we are not responsible at our premises or those of our suppliers shall release us from the obligation to deliver for the duration of the disruption and its effects.

4.4 In the event of a delay in delivery, the Purchaser may assert the following rights:

a) We shall be liable in accordance with the statutory provisions if the delay in delivery is due to an intentional or grossly negligent breach of contract for which we are responsible; fault on the part of our representatives or vicarious agents shall be attributed to us. Unless the delay in delivery is due to an intentional or grossly negligent breach of contract for which we are responsible, our liability for damages shall be limited to the foreseeable, typically occurring damage.

b) We shall also be liable in accordance with the statutory provisions if the delay in delivery for which we are responsible is based on the culpable breach of a material contractual obligation; in this case, however, the liability for damages shall be limited to the foreseeable, typically occurring damage. Material contractual obligations are obligations the fulfillment of which is a prerequisite for the proper performance of the contract and on the fulfillment of which the customer may regularly rely.

c) If the delay in delivery is due to a culpable breach of a non-substantial contractual obligation, the Purchaser shall be entitled to claim liquidated damages for each completed week of delay in the amount of 3% of the delivery value, but not more than 10% of the delivery value. Beyond that, no compensation will be provided in this case.

5 Transfer of risk and shipment

5.1 The risk of accidental loss shall pass to the Purchaser upon handover of the goods to the transport company, but no later than as soon as the goods leave our factory in Tuttlingen. This shall also apply if partial deliveries are made or if we have assumed other services, e.g. shipment or delivery.

5.2 If shipment is delayed due to circumstances for which the Purchaser is responsible, the risk shall pass to the Purchaser from the date of readiness for shipment. In such cases, we shall store the goods at the customer’s expense and shall then be entitled to charge the customer 1% of the invoice amount of the stored delivery per month or part thereof, up to a maximum of 10%.

5.3 Partial deliveries are permissible.

5.4 We choose packaging and mode of shipment at our discretion. The purchaser is obliged to carefully inspect the delivered goods without delay, to immediately notify the delivering carrier on site of any recognizable transport damage and to notify us in writing without delay, at the latest within 5 working days. If the purchaser fails to do so, the goods shall be deemed to have been approved with regard to recognizable transport damage.

6. Call orders

6.1 Supply contracts without a fixed delivery date (“on call”) may be agreed.

6.2 If the agreed delivery quantity has not been called by the customer within the call period, we shall be entitled to demand the (remaining) purchase price concurrently against delivery of the remaining quantity.

7. Goods return

7.1 The Purchaser may return the goods to us within 30 days of the invoice date. However, our written consent must be obtained prior to any return shipment. The delivery of the return shipment approved by us must be made free Tuttlingen. Implants and sterile products with opened packaging or damaged labels cannot be returned and will be returned to the purchaser without credit. Custom-made products can generally not be returned.

7.2 Returns will be credited on the basis of the calculated net value of the goods less a discount of 15%. Any reworking costs incurred to restore the returned goods ready for sale will be additionally deducted.

7.3 The return option does not apply to goods that no longer appear in our respective valid price list or to discontinued models and custom-made products. Implants can only be returned in unopened original packaging.

8. Warranty/notice of defects

8.1 We guarantee that the design and materials are free of defects in accordance with the current state of medical technology and that the goods are manufactured in accordance with the technical standards applicable in Germany.

8.2 The warranty period shall be one year from the date of delivery, unless special statutory provisions apply to medical products. Excluded from the warranty are wearing parts, transport damage and damage due to improper handling or as a result of improper use or improper use or damage due to chemical, electronic or weather-related influences.

8.3 The Purchaser shall inspect the goods for defects immediately upon receipt. Complaints of obvious defects can only be taken into account if they are made in writing within 14 days after receipt of the goods.

Hidden defects must be reported in writing immediately after discovery.

8.4 In all other respects, the Purchaser shall be entitled to the statutory rights in the event of defects.

9. Liability

9.1 We shall be liable in accordance with the statutory provisions if the Customer asserts claims for damages based on our culpable conduct (including that of our vicarious agents and legal representatives) and our conduct results in injury to life, limb or health.

9.2 If we (or our vicarious agents or legal representatives) merely negligently breach a material contractual obligation, our liability for damages shall be limited to the reasonably foreseeable and typically occurring damage. Material contractual obligations are obligations the fulfillment of which is a prerequisite for the proper performance of the contract and on the fulfillment of which the customer may regularly rely. We do not assume any liability for the merely negligent breach of secondary contractual obligations.

9.3 Any further liability, in particular for loss of profit, is excluded.

9.4 Claims under the Product Liability Act or based on special regulations for medical devices shall remain unaffected by the limitation of liability.

10. Retention of title

10.1 We reserve title to the delivered goods until the customer has settled all claims arising from our business relationship. The customer may only sell the goods subject to retention of title in the normal course of business and may neither pledge them nor assign them by way of security. He must inform us immediately of any access by third parties. The purchaser is obliged to secure our rights of retention in the event of resale of the goods, in particular to pass on our retention of title to his customers.

The customer assigns to us in advance as security his claim arising from the resale of the goods subject to retention of title to the extent of our ownership share in the goods sold. We accept this assignment already now. The customer shall be entitled to collect the claims as long as he meets his payment obligations towards us and does not fall into financial collapse. If it appears to us that the realization of our claims is at risk, the customer shall, at our request, enable us to take back the goods subject to retention of title or notify his customers of the assignment of claims and provide us with all necessary information and documents. Taking back goods subject to retention of title does not mean withdrawal from the contract.

We undertake to release the securities to which we are entitled insofar as their value exceeds the claims to be secured, insofar as these have not yet been settled, by more than 20%.

10.2 In the event of conduct by the Purchaser in breach of the contract, in particular in the event of default in payment, we shall be entitled to take back the (Retained) Goods without withdrawing from the contract and to subsequently proceed in accordance with Clause 3.5, sentence 2.

11. Industrial property rights

11.1 The Customer may use our trademarks, trade names and other marks as well as other industrial property rights only within the scope of what is customary in the trade and in compliance with the relevant protective laws.

11.2 If the goods are manufactured on the basis of drawings or other information provided by the Purchaser, the Purchaser alone shall be responsible for ensuring that the property rights of third parties are not infringed in this respect. The Purchaser shall indemnify us against all third party claims in this respect for infringement of industrial property rights (including legal costs) and, at our request, shall support us to the best of its ability in any legal dispute.

12. Product traceability

12.1 Product tracing

12.2 The Purchaser shall establish and maintain a traceability system at least for medical device classifications IIa, IIb and III (according to Annex IX of EC Directive 93/42/EEC). This system makes it possible to track every product we deliver all the way to the end customer. Consequently, the Purchaser shall pass on to its customer the LOT number assigned by us to the respective product. Upon our request, the Purchaser shall immediately inform us at any time about the type, scope and duration of its traceability system.

13. General

13.1 Our instructions on the further processing or use of the goods shall be strictly observed by the Purchaser. Otherwise, claims for defects shall not be recognized.

13.2 The place of performance shall be our registered office in D-78594 Gunningen.

13.3 In the event of any disputes arising from this contractual relationship, if the Customer is a merchant, a legal entity under public law or a special fund under public law, the action shall be brought before the court having jurisdiction for us at our registered office (currently Tuttlingen). In addition, we are also entitled to take legal action against the customer at the customer’s place of business.

13.4 German substantive law shall apply to the exclusion of the UN Convention on Contracts for the International Sale of Goods of 1980 (CISG).