General Terms and Conditions of Sale and Delivery of pritidenta® GmbH (26.05.2025)

1. General information

1.1 These General Terms and Conditions of Sale and Delivery ("GTC") govern the offer, sale and delivery of all products, in particular medical devices (hereinafter referred to as "Products") by pritidenta® GmbH (hereinafter referred to as "pritidenta") in the course of business to distributors, healthcare facilities and healthcare professionals, i.e. entrepreneurs ("Buyers"). The GTC shall become part of the purchase contract. Conflicting or differring terms and conditions or other restrictions on the part of the Buyer do not apply unless assented in writing by pritidenta. Supplementary conditions of the Purchaser or verbal agreements must be confirmed in writing by pritidenta.

1.2 These GTC also apply to all future similar transactions between pritidenta and the Buyer. The version of the GTC valid at the time of conclusion of the contract shall apply. 
 

2. Conclusion of contract

2.1 Offers from pritidenta are subject to change and non-binding, unless pritidenta has expressly designated them as binding in writing or by e-mail. A contract is only concluded upon pritidenta‘s acceptance in accordance with section 2.3.

2.2 Every order placed by the Buyer constitutes a binding offer. The order is usually placed by e-mail to orders@pritidenta.com.

2.3 The Buyer's offer can be accepted by pritidenta by written or electronic confirmation (including invoice or delivery bill) or by sending the goods. Acceptance, in whole or in part, is at the reasonable discretion of pritidenta. pritidenta will take particular account of the availability of the Product and the safeguarding of patient care. 

2.4 When placing the first order, the online platform offering pritidenta´s Products or pritidenta itself will check the Buyer's status as a distributor, healthcare facility or healthcare professional. The Buyer must provide the required proof that he is authorized to purchase the ordered Products. The Buyer must notify pritidenta immediately of any changes affecting these facts.

 

3. Nature of Products

In principle, the quality of the Products shall only be the quality described in the Product descriptions, specifications and labeling of pritidenta. Public statements, promotions or advertising do not constitute quality descriptions of the Products. Durability, product usage and application information, recipes, ingredients, weights and dimensions cannot be understood as a guarantee of a property.

 

4. Prices

4.1 Unless otherwise agreed, pritidenta's prices valid at the time of delivery will be applicable. These are quoted ex warehouse and uninsured. They are exclusive of freight and exclusive the applicable statutory sales tax.

4.2 Rebates and discounts shall only be granted in the event of a separate written agreement between pritidenta and the Buyer. 

 

5 Terms of payment

5.1 Unless otherwise agreed in writing, payments shall be made by bank transfer. Payments shall be made exclusively to the bank account specified by pritidenta in the invoice. They shall only be deemed to have been effected when the amount is finally available on an account of pritidenta. 

5.2 Unless otherwise agreed in writing, the purchase price must be paid in 14 calendar days after receipt of the invoice. If the Buyer is in default with a payment due, pritidenta is entitled to demand default interests of 9 % above the interest rate announced by the European central Bank per annum. pritidenta reserves the right to prove greater damages due to default. The Buyer is entitled to prove that no or only minor damage has been caused by the delay in payment.

5.3 If the Buyer is in default with a payment due, pritidenta is free to withhold further deliveries or to deliver only in the case of advance payment. Further statutory claims of pritidenta remain unaffected.

5.4 pritidenta reserves the right to use payments to settle the oldest due invoice items plus the default interest and costs accrued thereon, in the following order: costs, interest, principal claim.

5.5 The Buyer shall only be entitled to rights of set-off and retention if the counterclaims are undisputed, recognized or legally established. The Purchaser is only entitled to assert rights of retention on the basis of counterclaims arising from the same contractual relationship. The Buyer is not authorized to assign its contractual rights to third parties without the express written consent of pritidenta. Section 354a HGB remains unaffected. 

 

6. Delivery, transfer of risk

6.1 Delivery dates are non-binding, even if pritidenta specifies a precise date or a precisely determinable date when confirming the Buyer’s order, unless expressly agreed otherwise.

6.2 If a fixed delivery date has been expressly agreed, the Buyer must set a reasonable grace period of generally two weeks in the event of a delay in delivery. 

6.3 Partial deliveries are permissible. In the case of partial deliveries, pritidenta shall be entitled to corresponding partial payments.

6.4 Delivery shall be made as standard shipping Free Carrier (FCA) (Incoterms 2020) from Kaisersesch or Leinfelden-Echterdingen, Germany, at the Buyer's expense. If the Buyer wishes a different shipping method (e.g. express shipping) or a different transport company than that of pritidenta, this must be expressly agreed.

6.5 Unless otherwise agreed, the risk of accidental loss and accidental deterioration of the goods shall pass to the Buyer upon provision and notification of readiness for collection ("transfer of risk"). Additional costs for further storage after the transfer of risk shall be borne by the Buyer. 

6.6 Delivery is subject to timely and correct delivery to pritidenta. If pritidenta is not supplied on time despite the conclusion of a corresponding covering transaction for reasons for which pritidenta is not responsible, pritidenta shall be entitled to withdraw from the contract. pritidenta undertakes to inform the Buyer immediately of the non-availability in the event of untimely and incorrect self-delivery and to reimburse any payments made by the Buyer without delay.

 

7. Operational and production disruptions, force majeure, contractual impediments

7.1 If force majeure, other unusual circumstances for which pritidenta is not responsible (operational disruptions, labor disputes, Internet outages, official measures including pandemics, epidemics or diseases that require special measures such as quarantine) or circumstances that are within the sphere of influence of the Buyer prevent pritidenta from delivery, deliveryperiods are extended according toto the duration of the hindrance plus a reasonable start-up time. During this time, the Buyer has no rights or claims against pritidenta due to delay. This also applies if such hindrances occur at an upstream supplier. pritidenta shall inform the Buyer of such circumstances without delay. If pritidenta is in default at the time of the occurrence of the event, this is not the sole reason for assuming representation. 

7.2 Without prejudice to other rights, both the Buyer and pritidenta have the right to withdraw from the contract if the duration of the hindrance exceeds a period of eight weeks or if delivery is not possible for an unforeseeable period of time. 

 

8. Retention of title

8.1 Pritidenta retains title of delivered goods until the purchase price and all other obligations arising from the business relationship have been paid in full. The retention of title shall also remain in force if individual claims of pritidenta are included in a current account and the balance has been struck and recognized.

8.2 In the event of a breach of contract, pritidenta is entitled to take back the Products from the Buyer after setting a reasonable deadline. In this case, the Buyer is obliged to hand them over. This taking back of the Products by pritidenta constitutes a withdrawal from the contract.

8.3 The Buyer is authorized to sell the Products in the ordinary course of business However, he hereby assigns to pritidenta the purchase price and all claims arising from such a resale. If the assigned claim is included in a current account, the Buyer hereby assigns to pritidenta balance from the current account corresponding to the amount of this claim. The Buyer must notify its customers of the advance assignment to pritidenta and provide pritidenta with the information and documents required to assert the claim.

8.4 The processing or transformation of the Products by the Buyer shall always be carried out for pritidenta. When processing with other items not belonging to pritidenta, pritidenta shall acquire co-ownership of the new item in the proportion to the value of the Products to the other processed items at the time of processing. In all other respects, the same shall apply to the item created by processing as to the Products.

8.5 If the Products are inseparably combined or mixed with other products not belonging to pritidenta, pritidenta shall acquire co-ownership of the new item in proportion to the value of the Products to the other combined or mixed items at the time of combination or mixing. If the combination or mixing is carried out in such a way that the Buyer’s item is to be regarded as the main item, it is agreed that Buyer shall transfer co-ownership to pritidenta on a pro rata basis. The Buyer shall keep the sole ownership or co-ownership for pritidenta. 

8.6 If the value of the securities existing for pritidenta exceeds the claims by more than 20% in total, pritidenta shall be obliged to release securities of pritidenta's choice at the Buyer's request.

8.7 The Buyer is obliged to treat the Products with care for the duration of the retention of title and to insure them appropriately at his own expense against all usual risks, in particular theft, fire and water damage. 

8.8 The Buyer must inform pritidenta immediately in writing in the event of seizure or other interventions by third parties in the Products. The Buyer shall be liable to pritidenta for the loss incurred if the third party is unable to reimburse pritidenta for any legal and judicial costs. 

 

9. Warranty, obligation to give notice of defects, returns

9.1 Warranty claims of the Buyer require that the Buyer complies with his inspection and complaint obligations pursuant to section 377 HGB. Complaints due to incomplete or incorrect delivery as well as complaints about obvious defects must be made in writing immediately, but at the latest within 5 (five) working days of receipt of the Products.

9.2 In the case of hidden defects, the written complaint must be made immediately after discovery of the defect, at the latest within five (5) working days of discovery. The burden of proof that the defect is hidden shall lie with the Buyer. 

9.3 pritidenta shall not be responsible for any loss of quality or reduction in the effectiveness of the pritidenta Products if the Products have not been stored properly by the Buyer or have been stored beyond the shelf life limit. If improper repair work or modifications are carried out by the Buyer or third parties, no claims for defects shall exist for these and the resulting consequences.

9.4 Unless the parties have agreed otherwise, the Buyer's claims for defects are limited to the right to subsequent performance. If subsequent performance by pritidenta fails, the Buyer may reduce the purchase price or withdraw from the contract at his discretion. Section 478 BGB remains unaffected. The Buyer shall be entitled to claim damages in accordance with Section 10 . Defective Products are only to be returned after consultation with pritidenta in order to enable proper coordination of the subsequent performance.

9.5 The limitation period for claims for defects is 1 year from transfer of risk of delivered Products. Excluded from this are claims for defects by consumers and claims for damages due to culpable injury to life, body or health and/or claims for damages due to grossly negligent or intentional damage caused by pritidenta, its legal representatives and vicarious agents. In addition, the provisions of Section 438 Para. 3 BGB 478 and 479 BGB remain unaffected.

9.6 Defect-free Products will only be taken back or exchanged after prior written agreement. This also applies to expired Products. Under no circumstances will replacements be supplied for a) Products marked as samples, b) damaged, opened or opened packages, unless this is due to a delivery error.

9.7 Products recalled for reasons of product safety (based on authority recall or recall by pritidenta) will be reimbursed at the purchase price, provided that the return is made within one (1) month of the publication or notification of the product recall, subject to clause 9.6.

 

10. Liability

10.1 pritidenta shall be liable without limitation in accordance with the statutory provisions for damages resulting from culpable injury to life, body or health as well as for other damages due to intentional or grossly negligent breach of duty. Insofar as the scope of application of the Product Liability Act is opened up, pritidenta shall be liable without limitation in accordance with its provisions.

10.2 For damages caused by simple or slight negligence, pritidenta shall be liable if it violates an essential contractual obligation (so-called cardinal obligations). Liability is limited to the foreseeable damage typical for the contract. 

Further, in this case, pritidenta's liability is limited to €5,000,000 per loss event and to a maximum of €10,000,000 per calendar year. 

10.3 The above limitations of liability also apply in favor of organs, employees and legal representatives of pritidenta as well as its vicarious agents if claims are asserted directly against them.

10.4 pritidenta is not liable for damage resulting from improper handling or improper use of the Products supplied.

 

11. Sales and quality assurance

11.1 Medical devices may only be purchased from and delivered to authorized distributors or institutions. The Buyer assures that both the delivery of the Products to him and the further commercial steps planned by him are in accordance with the applicable law. The Buyer shall provide pritidenta with corresponding evidence on request.

11.2 The Buyer shall ensure that the storage and transportation conditions specified for the Products are complied with (pritidenta provides information on the storage and transportation conditions for its own Products in the instructions for use and on the primary packaging).

11.3 If the Buyer is a distributor within the meaning of the MDR, the Buyer undertakes to fulfill the basic requirements of Art. 14 MDR ("General obligations of distributors") with regard to the Products. These include in particular

 

12. Information and cooperation obligations

12.1 The Buyer must inform pritidenta in writing by e-mail to support@pritidenta.com of all incidents, even if it is not subject to any statutory or official obligation to provide information, reported Product defects and risks when using the Products as well as other circumstances that could make a warning or recall campaign necessary, with the subject "Incident". This forementioned address also applies to the following reporting obligations. 

12.2 The Buyer must inform pritidenta immediately of any possible forgeries, corresponding suspicions and any illegal trading with regard to the Products of which he becomes aware.

12.3 If the Buyer is a healthcare facility or a healthcare professional, it must in particular comply with the reporting obligations under the MPAMIV regarding suspected serious incidents to pritidenta and the competent authorities.

12.4 If the Buyer is a distributor, he shall immediately inform pritidenta and - in the case of commercial products from other manufacturers that he has purchased from pritidenta - also the respective manufacturer if he is of the opinion or has reason to believe that

In particular, the buyer shall provide information on non-conformity and corrective measures already taken.

12.5 The Buyer shall cooperate with pritidenta and, if applicable, with the manufacturer of the third party products supplied by pritidenta and the competent authority to ensure that the necessary corrective action is taken to restore the conformity of the Product or to withdraw it from the market or recall it.

12.6 The Buyer

12.7 If the Buyer is a distributor, it shall keep a register of complaints, non-compliant products, recalls and withdrawals, provide pritidenta or, in the case of commercial products from third party manufacturers purchased by pritidenta, all requested information to them on request and keep them informed of monitoring measures.

 

13. Ensuring traceability

13.1 The Buyer cooperates with pritidenta to achieve an appropriate level of Product traceability.

13.2 The Buyer shall ensure that, irrespective of the duration of the contract, he/she is responsible to the authorities for at least 10 years (and 15 years in the case of implantable products, i.e. the company's zirconium oxide probes) after the last Product has been placed on the market.

in particular with indication of 

can be documented.

 

14. Place of performance, choice of law, place of jurisdiction, validity clause

14.1 The place of performance for delivery is the pritidenta warehouse in Kaisersesch, Plaidt or Leinfelden-Echterdingen, for payment the place stated on the pritidenta invoice.

14.2 The rights and obligations of the parties arising out of or in connection with these GTC are subject to German law excluding German conflict of laws rules and excluding all international and supranational (contractual) legal systems, in particular the United Nations Convention on Contracts for the International Sale of Goods of April 11, 1980 (CISG).

14.3 The parties undertake to settle all disputes arising from or in connection with a contract amicably in the first instance through discussions and negotiations. All disputes that cannot be settled amicably shall be decided exclusively by the competent courts in Stuttgart, Germany, with the proviso that pritidenta shall also be entitled to assert its claims at the Buyer's general place of jurisdiction.

14.4 Should individual clauses of these GTC be invalid in whole or in part, this shall not affect the validity of the remaining clauses or the remaining parts of such clauses. The invalid clause shall be replaced by an appropriate provision that comes closest to the economic purpose of the invalid provision and is effective.