1 General / Scope of application

1.1 Our terms of delivery and payment apply to all business relationships with our customers, and the customer recognises them as binding for him when placing an order.

1.2 Provisions deviating from the following and/or statutory provisions - in particular in the customer's terms and conditions of purchase - shall only be binding on us if they have been confirmed in writing. This also applies to conditions that are not regulated in our terms of delivery and payment. The unconditional delivery of goods or the acceptance of payments shall not constitute our acceptance of deviating provisions.

1.3 All agreements made between us and the buyer for the purpose of executing a contract are set out in writing in the contract and in these applicable terms and conditions. Amendments, supplements or the cancellation of a contract or these terms and conditions shall only become effective upon our written confirmation.

1.4 Our terms of delivery and payment also apply to repeat orders.

1.5 Our terms of delivery and payment apply worldwide, with the exception of the United States of America.

2 Offers / Offer documents

2.1 Our quotations are subject to change unless otherwise agreed.

2.2 Illustrations, drawings, calculations and other product-, application- or project-related documents remain our property and are subject to copyright, even if we provide them to the buyer; they may not be reproduced or made accessible to third parties without our express prior written consent.

3 Prices / Terms of payment

3.1 Unless otherwise agreed, our prices are "ex works". The costs for packaging, insurance, freight and VAT are not included and will be invoiced separately. VAT shall be shown separately on the invoice at the statutory rate on the day of invoicing. If we have not received a written request from the recipient for uninsured shipping in advance, we will insure all our shipments worldwide at the recipient's expense.

3.2 In the case of customised production, we are entitled to deliver 10% more or less than the order quantity and to invoice accordingly.

3.3 From an order value of EUR 500.00 net, the minimum quantity flat rate of EUR 50.00 shall not apply.

3.4 Unless otherwise agreed, the net purchase price (without deduction) is due for payment within 30 days of the invoice date. The deduction of a discount requires a special written agreement.

3.5 If the Buyer is in default of payment, we shall be entitled to charge interest on arrears at a rate of 8% above the applicable base rate. We shall be entitled to demand reminder fees of EUR 30 to EUR 60 for each reminder, depending on the level of reminder.

3.6 If, after conclusion of the contract, a significant deterioration in the Buyer's financial circumstances becomes apparent which jeopardises our claim to counter-performance, we may refuse performance until the counter-performance has been effected or security has been provided for it. If the buyer is not prepared to fulfil the contract "step by step" or to provide security after a reasonable deadline set by us has expired, we shall be entitled to withdraw from the contract.

3.7 The buyer shall only be entitled to set-off rights if these are recognised by us as existing and due or have been legally established. The purchaser is authorised to exercise a right of retention insofar as his counterclaim is based on the same contractual relationship.

4 Delivery, delivery times, partial deliveries

4.1 Compliance with our delivery obligation presupposes the timely and proper fulfilment of the buyer's obligations, in particular compliance with the agreed terms of payment. The defence of non-performance of the contract remains reserved.

4.2 The delivery periods agreed in writing shall commence on the date of our confirmation, but not before clarification of all technical and commercial details and submission of any necessary authorisations. Any changes in the design of the delivery item requested by the buyer within the delivery period shall suspend the expiry of the period and extend the delivery period accordingly.

4.3 The occurrence of unforeseen events, force majeure and non-delivery by our suppliers through no fault of our own shall entitle us to postpone delivery for the duration of the hindrance and a reasonable start-up period.

4.4 Partial deliveries are permissible to a reasonable extent.

4.5 If we are in default of delivery, the buyer is entitled to set us a reasonable period of grace in writing. If the delivery item is not dispatched by us within this period of grace, the buyer is entitled to withdraw from the contract for those parts that have not been dispatched by the expiry of the period of grace. We shall be liable for any demonstrable damage incurred by the purchaser due to a delay caused by us. Our liability is limited in such a way that the buyer can demand 0.5 per cent for each completed week of delay, but no more than a total of 5 per cent of the price for that part of the delivery which could not be put to the intended use due to the delay. This does not imply a change in the burden of proof to the detriment of the buyer. The Buyer's statutory right of cancellation shall remain unaffected.

4.6 If the delivery is delayed for reasons for which the Buyer is responsible, the Buyer may be charged storage fees amounting to 0.5 per cent of the price of the delivery items for each month or part thereof, but not more than a total of 5 per cent. After expiry of a reasonable period of grace, we shall be entitled to dispose of the delivery item otherwise and to supply the buyer within an extended period. The contracting parties are at liberty to prove that higher, lower or no storage costs were incurred. The statutory rights to withdraw from the contract and to demand compensation remain unaffected.

4.7 If the buyer is in default of acceptance or violates other obligations to co-operate, we shall be entitled to demand compensation for the damage incurred by us in this respect, including any additional expenses. We reserve the right to assert further claims.

5 Dispatch, transfer of risk

Unless otherwise agreed, delivery shall be made using the mode of dispatch we consider most favourable. All deliveries are ex works, at the expense and risk of the recipient. At the request of the customer and against reimbursement of the additional costs, we will also carry out special types of dispatch (e.g. express transport) or partial deliveries.

6 Notice of defects, warranty, liability

6.1 The buyer must inspect the delivery immediately upon receipt with due diligence and notify us in writing of any defects immediately, but at the latest within seven days of delivery (obvious defects) or discovery. Otherwise the delivery shall be deemed approved.

6.2 Warranty claims shall not exist in the event of natural wear and tear or damage arising after the transfer of risk as a result of incorrect or negligent handling, excessive use, unsuitable operating materials or due to special external influences which are not assumed under the contract. If improper modifications or repair work are carried out by the purchaser or third parties, no warranty claims shall exist for these and the resulting consequences.

6.3 If there is a defect for which we are responsible, we are entitled, at our discretion, to remedy the defect or make a new delivery.

6.4 If we refuse to rectify the defect or make a new delivery, if it becomes unreasonable for the buyer or if it fails, the buyer may, at his discretion, withdraw from the contract or reduce the purchase price by a reasonable amount. However, this presupposes that there is no doubt as to the justification of the complaint. If the notice of defects is unjustified, we shall be entitled to demand compensation from the Buyer for the expenses incurred by us.

6.5 Unless otherwise stated below, other or further warranty claims, in particular claims for damages in lieu of performance, are excluded. We are therefore not liable for damage that has not occurred to the delivery item itself; in particular, we are not liable for loss of profit or other financial losses of the buyer.

6.6 The above exclusion of liability shall not apply if the damage is due to a grossly negligent or wilful breach of duty or if damages are claimed for injury to life, limb or health or if the purchaser claims damages due to the absence of a warranted characteristic. In the latter case, however, claims for damages can only be asserted to the extent that the warranty of quality covers the risk of consequential damage and the damage incurred is based on its absence.

6.7 The warranty period is one year from the transfer of risk (Clause 5).

6.8 Claims for personal injury or damage to privately used items under the Product Liability Act remain unaffected by the above provisions.

7 Returns

7.1 We will only accept returns of goods in their original packaging and unused goods within two weeks of receipt of the goods and with our prior consent. If goods are returned in their original packaging, we will charge 25% of the net value of the goods. If, in exceptional cases, we agree to take back goods that are not in their original packaging, the processing fees incurred will be charged at cost, but at least 20% of the net value of the goods.

7.2 Goods can only be returned if the lot number is stated.

7.3 Special orders and customised products as well as sterile goods are generally excluded from exchange.

8 Retention of title

8.1 Delivered goods shall remain our property (reserved goods) until all our claims against the buyer arising from the business relationship have been fulfilled.

8.2 In the event of breaches of duty by the Buyer, in particular in the event of default in payment, we shall be entitled to withdraw from the contract and take back the goods; the Buyer shall be obliged to surrender the goods. The taking back or assertion of the retention of title does not require the supplier to withdraw from the contract; these actions or a seizure of the reserved goods by us do not constitute a withdrawal from the contract unless we have expressly declared this.

8.3 The purchaser is entitled to resell the goods in the ordinary course of business; however, he hereby assigns to us all claims in the amount of the final invoice amount (including sales tax) which accrue to him from the resale against his customers or third parties, irrespective of whether the delivered goods have been resold without or after further processing. The buyer remains authorised to collect this claim even after the assignment. Our authorisation to collect the claim ourselves remains unaffected by this. However, we undertake not to collect the claim as long as the purchaser fulfils his payment obligations from the collected proceeds, is not in default of payment and, in particular, no application for the opening of insolvency proceedings has been filed and payments have not been suspended. If this is the case, however, we can demand that the buyer informs us of the assigned claims and their debtors, provides all information necessary for collection, hands over the relevant documents and informs the debtors (third parties) of the assignment.

8.4 For the duration of the retention of title, the Buyer is prohibited from pledging the goods or transferring them by way of security. In the event of seizure, confiscation or other dispositions or interventions by third parties, the buyer must inform us immediately so that we can assert our rights. If the third party is not in a position to reimburse us for the judicial and extrajudicial costs of an action pursuant to § 771 ZPO, the buyer shall be liable for the loss incurred by us.

8.5 The buyer is obliged to treat the purchased item with care; in particular, he is obliged to insure it adequately at his own expense against fire, water damage and theft at replacement value. If maintenance and inspection work is required, the buyer must carry this out in good time at his own expense.

8.6 The processing or remodelling of the object of sale by the buyer is always carried out for us. If the purchased item is processed or inseparably mixed with other items not belonging to us, we shall acquire co-ownership of the new item in the ratio of the value of the purchased item (final invoice amount, including VAT) to the other items at the time of processing or mixing. In all other respects, the same shall apply to the item created by processing or mixing as to the purchased item delivered under reservation of title. If the mixing takes place in such a way that the buyer's item is to be regarded as the main item, it is agreed that the buyer shall transfer co-ownership to us on a pro rata basis. The buyer shall keep the sole ownership or co-ownership thus created for us.

9 Special provisions for ordering prosthetic elements, jaw models and templates on the basis of scanned data

9.1 If the buyer orders prosthetic elements, jaw models and templates by electronically transmitting data generated with a scanner (hereinafter referred to as "scan orders"), the following provisions shall also apply:

9.2 When ordering prosthetic elements, jaw models and templates electronically, the Buyer waives receipt of a declaration of acceptance from Meisinger. The order can only be placed if the user interface form provided by Meisinger has been completed in full.

9.3 In order for Meisinger to be able to fulfil its delivery obligations from scan orders, the Buyer must fulfil its obligations to cooperate properly and in good time. In particular, the buyer must ensure that the data is recorded correctly using the scanner, that it contains all the necessary information and that the scanned data is transmitted to us in full. Employees who operate the scanner and place scan orders must therefore be trained accordingly.

9.4 In the case of scan orders, Meisinger shall produce the prosthetic elements, jaw models and templates in accordance with the data transmitted to Meisinger and from the material selected by the buyer. Therefore, there shall be no claims for defects that are based on incorrect operation of the scanner, incorrect transmission of the scanned data due to errors in the line used by the Buyer, the ordering of unsuitable materials or the fitting of the dental prosthetic element on the patient. Finally, there are no claims for defects if the defect is due to reworking or modification of the prosthetic elements, jaw models and templates by the buyer.

9.5 If the buyer complains about a material defect in a prosthetic element, jaw model and template, the buyer must send this to Meisinger immediately together with the previously scanned model in order to give Meisinger the opportunity to examine the complaint. If Meisinger comes to the conclusion that the buyer has scanned the model improperly and has therefore transmitted incorrect data, Meisinger shall inform the buyer immediately and send him both data sets as proof. In such cases, Meisinger shall only manufacture and deliver a further prosthetic element, jaw model and template at the Buyer's expense using the correct data set if instructed to do so by the Buyer.

10 Special regulations for the Meisinger Digital Service

10.1 If the customer uses the Meisinger Digital Service, Meisinger will manufacture the customised abutment or another prosthetic element according to the design and dimensions of the wax-up model to be supplied by the customer. The wax-up model must be new and must not have been used before. By submitting the wax-up model, the customer recognises that he has approved the design and production in advance (design release). Meisinger is not responsible for defects in the design or the fit of the prosthetic element. The wax-up model must be disinfected upon delivery to Meisinger. The customer must confirm the disinfection in a written declaration. Furthermore, the packaging of the wax-up model must comply with the applicable transport and safety laws.

10.2 If the customer uses the Meisinger Digital Service, Meisinger shall develop and manufacture the prosthetic element exclusively in accordance with the design parameters and dimensions specified by the customer in the order (whether in the order form or online). Meisinger shall not change the design parameters, dimensions and shape specified and approved by the customer. Meisinger is not responsible for defects in the design or fit of the prosthetic element.

10.3 The customer's wax-up model will not be returned to the customer, but will be destroyed ninety days after delivery of the prosthetic element. If the customer has not lodged a written complaint before the expiry of this period, it shall be deemed to have approved that both the design and the dimensions of the prosthetic element match the wax-up model.

10.4 If the customer modifies or processes the prosthetic element supplied by Meisinger, any liability for defects on the part of Meisinger is excluded.

11 Special regulations for orders via the Meisinger Internet portal

11.1 The Internet portal on the websites www.meisinger.de and www.meisinger.de/shop as well as other digital services on the Meisinger homepage are aimed at persons authorised on the basis of their professional qualifications (dentists, dental laboratories, etc.) who have unlimited legal capacity and are entrepreneurs within the meaning of the German Civil Code.

11.2 Registration is required in order to place orders via the Internet portal. The user name and password are not transferable to third parties. The pages associated with the order are only accessible to registered users of the Internet portal.

11.3 Offers made by Meisinger on the Internet portal are subject to change. The buyer's order is placed by entering the information requested on the order form and sending the order to the Internet portal. The buyer's order is binding. The buyer shall first receive an electronic confirmation of receipt of the order. Meisinger will then check the information sent by the buyer. If the result of this check is positive, Meisinger shall accept and fulfil the order.

11.4 Delivery periods or delivery dates shall only be binding if they are expressly set out in writing when the contract is concluded. General information on the Internet portal does not constitute a guarantee of deadlines and dates.

11.5 Payments by credit card or PayPal are always due immediately. 12.6 Section 312i para. 1 sentence 1 no. 1, 2 and 3 as well as section 312i para. 1 sentence 2 BGB, which provide for certain obligations of the entrepreneur in the case of contracts in electronic business transactions, are waived.

12 Provisions based on REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices

Article 14: General obligations of distributors

12.1 When making a device available on the market, distributors shall act with due care in relation to the applicable requirements.

12.2 Before making a device available on the market, distributors shall verify that all of the following requirements are met:

(a) the product bears the CE marking and an EU declaration of conformity has been issued for the product;

(b) the product is accompanied by the information provided by the manufacturer in accordance with Article 10(11) (labelling and instructions for use)

c) for imported devices, the importer has fulfilled the requirements set out in Article 13(3) (Labelling obligation Hager & Meisinger in its role as importer);

d) where applicable, a UDI has been assigned by the manufacturer.

In order to fulfil the requirements referred to in points (a), (b) and (d) of the first subparagraph, the distributor may apply a sampling procedure that is representative of the devices it supplies.

Where a distributor considers or has reason to believe that a device is not in conformity with the requirements of this Regulation, he shall not make the device concerned available on the market until it has been brought into conformity, in which case he shall inform the manufacturer and, where applicable, the manufacturer's authorised representative and the importer. If the importer considers or has reason to believe that the device presents a serious risk or is a falsified device, he shall also inform the competent authority of the Member State in which he is established.

12.3 While the product is under their responsibility, distributors shall ensure that the storage and transport conditions (information on the packaging or in the instructions for use) comply with the manufacturer's specifications.

12.4 Distributors who consider or have reason to believe that a device which they have made available on the market is not in conformity with this Regulation shall immediately inform the manufacturer and, where applicable, the manufacturer's authorised representative and the importer. Distributors shall cooperate with the manufacturer and, where applicable, the manufacturer's authorised representative and the importer, and with the competent authorities to ensure that corrective action is taken, if necessary, to bring the device into conformity, to withdraw it from the market or to recall it. Furthermore, where the distributor considers or has reason to believe that the product presents a serious risk, he shall immediately inform the competent authorities of the Member States in which he made the product available, giving details, in particular, of the non-compliance and of any corrective measures taken.

12.5 Distributors who receive complaints and reports from healthcare professionals, patients or users about suspected incidents related to a device which they have made available shall immediately forward them to the manufacturer and, where applicable, the manufacturer's authorised representative and the importer. They shall keep a register of complaints, of non-conforming devices and of recalls and withdrawals, and shall keep the manufacturer and, where applicable, the manufacturer's authorised representative and the importer informed of such monitoring and provide them with any information at their request.

12.6 Distributors shall, on request, provide the competent authority with all information and documentation in their possession necessary to demonstrate the conformity of a product.

The obligation of the distributor referred to in the first subparagraph shall be considered fulfilled when the manufacturer or, where applicable, the authorised representative responsible for the product concerned provides the relevant information. Distributors shall co-operate with the competent authorities, at their request, on any action taken to eliminate the risks posed by devices which they have made available on the market. Distributors shall, upon request, provide a competent authority with samples of the device free of charge or, where this is not practicable, grant it access to the device.

13 Distributor obligations under the Medical Devices Regulation (EU) 2017/745 on Article 16

13.1 If the distributor intends to carry out activities in accordance with Article 16(1)(a) - (c), he shall also be subject to the obligations as a manufacturer and must therefore conclude a separate contract with Hager & Meisinger.

13.2 If Article 16(1)(c) is not applicable due to Article 16(2), the obligations as a manufacturer do not apply and no separate contract is required.

13.3 Article 16(3) and (4) must be complied with in any case.

14 Provisions based on REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices

Article 16: Cases in which the manufacturer's obligations also apply to distributors

14.1 A distributor has the obligations of the manufacturer when carrying out the following activities

(a) making a device available on the market under its own name, registered trade name or registered trade mark, except where a distributor or importer enters into an agreement with a manufacturer whereby the manufacturer is identified as such on the labelling and is responsible for compliance with the requirements applicable to manufacturers under this Regulation;

(b) a change in the intended purpose of a device already placed on the market or put into service;

(c) modification of a device already placed on the market or put into service in a way that could affect the compliance of the device with the applicable requirements.

Paragraph 1 shall not apply to non-manufacturers who assemble or adapt a device already placed on the market without changing its intended purpose for a specific patient.

14.2 For the purposes of point (c) of paragraph 1, the following activities shall not be considered as a modification of the device which could affect its conformity with the applicable requirements:

(a) making available, including translation, the information to be provided by the manufacturer in accordance with Section 23 (Labelling and instructions for use) of Annex I concerning a device already on the market and other information necessary for the marketing of the device in the Member State concerned;

(b) changes to the outer packaging of a device already on the market, including changes to the pack size, where repackaging is necessary in order to market the device in the Member State concerned and provided that this is done under conditions which ensure that the original condition of the device cannot be affected. In the case of devices placed on the market in sterile condition, the original condition of the packaging shall be deemed to be compromised if the packaging necessary to maintain sterility is opened, damaged or otherwise compromised during repackaging.

14.3 A distributor who carries out any of the activities referred to in paragraph 2(a) and (b) shall indicate on the device or, where this is impracticable, on the packaging or on a document accompanying the device, the activity concerned, his name, registered trade name or registered trade mark, his registered place of business and the address at which he can be contacted so that his actual location can be ascertained.

Distributors shall ensure that they have a quality management system in place that includes procedures to ensure that the translation of the information is accurate and up to date and that the activities referred to in points (a) and (b) of paragraph 2 are carried out by means and under conditions that ensure that the original condition of the product is maintained and that the packaging of the repackaged product is not defective, of poor quality or untidy. The quality management system shall also include procedures to ensure that the distributor is informed of any corrective action taken by the manufacturer in relation to the product concerned in response to safety problems or to bring the product into conformity with this Regulation.

14.4 At least 28 days before the relabelled or repackaged device is made available on the market, distributors carrying out any of the activities referred to in paragraph 2(a) and (b) shall inform the manufacturer and the competent authority of the Member State in which they intend to make the device available of their intention to make the relabelled or repackaged device available on the market and shall, on request, provide the manufacturer and the competent authority with a sample or model of the relabelled or repackaged device, including the translated label and the translated instructions for use. The manufacturer shall, within the same 28-day period, provide the competent authority with a certificate, issued by a notified body and intended for the type of devices covered by the activities referred to in points (a) and (b) of paragraph 2, attesting that the quality management system of the distributor or importer fulfils the requirements laid down in paragraph 3.

15 Effectiveness of the contract

Should one or more provisions of these General Terms and Conditions of Delivery and Payment be or become invalid, this shall not affect the validity of the remaining provisions. Rather, the invalidity of the provisions shall be replaced by a provision that comes closest to the recognisable interests.

16 Place of fulfilment, place of jurisdiction, applicable law

16.1 For all rights and obligations arising from our deliveries and services, our registered office shall be the place of fulfilment and jurisdiction for both parties. We are optionally entitled to sue at the buyer's place of business.

16.2 German law shall apply exclusively. The application of the UN Convention on Contracts for the International Sale of Goods (CISG) is excluded.

16.3 The data provided by the buyer will be stored and processed in computerised form to the extent permitted by data protection law.

Status: February 2021