DISCLAIMER

The information provided on this website is for general informational and educational purposes only. Please read and review these Terms of Use carefully before accessing or using this website. By accessing or using this website, you acknowledge that you have read, understood and agree to this Terms of Use Agreement. If you do not agree to the Terms of Use, you may not access or use the site.

Terms of Use All content of this website is owned or controlled by REGEDENT AG and its affiliates (“REGEDENT”) or their suppliers and is protected by copyright and intellectual property laws internationally. REGEDENT grants you a limited and restricted license to access and download content only for your personal, non-commercial use. No modification or further reproduction of the content is permitted. The content may not otherwise be copied or used in any way without the prior express permission of REGEDENT.

The information provided here is general in nature. If you have or suspect you have a problem related with the content provided on this website, you should consult a professional contact person. Physicians should read the package inserts prior to use.

REGEDENT will use reasonable efforts to include up-to-date and accurate information on this website, but makes no representations, warranties, or assurances as to the availability, accuracy, correctness, or completeness of this website, its information or its contents. REGEDENT shall not be liable for any damages or injury resulting from your access to, or inability to access, this website, or from your use of, or reliance on, this website or any information provided at this website.

This website may provide links or references to other sites and may be accessed by links from third party websites over which REGEDENT has no control. REGEDENT has no responsibility for the content of such other sites and shall not be liable for any damages or injury arising from that content or that access. Any links to other sites are provided as merely a convenience to the users of this website. REGEDENT reserves the right to delete, modify or supplement the content, links or references of this site at any time, for any reason, without notification. Products referred to on this website may not be licensed for sale in all jurisdictions. Any offer of any product made on this Web site is void where prohibited. Please contact your local REGEDENT representative for a full and current listing of products available in your particular market.

THIS WEB SITE AND ITS CONTENTS AND INFORMATION ARE PROVIDED “AS IS” WITHOUT WARRANTIES OF ANY KIND. TO THE FULLEST EXTENT PERMISSIBLE BY APPLICABLE LAW AND EXCEPT AS SPECIFICALLY SET FORTH HEREIN, REGEDENT DOES NOT MAKE ANY WARRANTIES OR REPRESENTATIONS OF ANY KIND WITH RESPECT TO THE WEB SITE, ITS CONTENT, OR PRODUCTS OR SERVICES THAT REGEDENT OR ANY OTHER THIRD PARTY PROVIDES OR SELLS. REGEDENT EXPRESSLY DISCLAIMS ALL IMPLIED AND EXPRESS WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR NON-INFRINGEMENT WITH RESPECT TO THE SAME. REGEDENT

WILL NOT BE LIABLE FOR ANY DAMAGES OF ANY KIND ARISING FROM THE USE OF THIS WEB SITE, INCLUDING, BUT NOT LIMITED TO, DIRECT, INDIRECT, INCIDENTAL, PUNITIVE AND CONSEQUENTIAL DAMAGES. WITHOUT LIMITING THE FOREGOING, NO WARRANTY IS GIVEN THAT THE WEB SITE OR ANY INFORMATION REGEDENT PROVIDES TO YOU WILL BE UNINTERRUPTED, FREE OF VIRUSES, OR ERROR FREE.

Some jurisdictions do not allow the disclaimer of implied warranties, so the foregoing disclaimer may not apply to you.

Portrayals of persons shown on this site are for purposes of illustration only. These individuals are not actual users of, or patients who have received treatment with, REGEDENT products, unless otherwise specifically stated. All product names, whether or not appearing in large print or with the trademark symbol, are trademarks of REGEDENT, its affiliates, related companies or its licensors or joint venture partners, unless otherwise noted.

GENERAL TERMS AND CONDITIONS

1. Scope of the General Terms and Conditions

These General Terms and Conditions (GTCs) shall be a component of all agreements governing deliveries and other services provided between REGEDENT AG (hereinafter referred to as REGEDENT) and its clients. REGEDENT may revise or amend the GTCs at any time and at its own discretion. The currently applicable GTCs are published at www.regedent.com. Differing terms and conditions shall only apply if expressly accepted by REGEDENT in writing.

2. Conclusion of agreements

All REGEDENT offerings as well as all technical specifications, catalogue illustrations, product descriptions, etc. shall be non-binding unless a binding offer is expressly made by REGEDENT. The offer shall be deemed to have been accepted as soon as it is signed and returned by the client or the client provides notification of approval via e-mail. Client orders shall also only apply subject to the currently applicable GTCs of REGEDENT.

3. Prices and payment conditions, client default, right of retention, offsetting

3.1 Unless expressly agreed otherwise, prices shall be determined on the basis of the REGEDENT price list valid at the time the order is made. All prices are stated in Swiss francs including the statutory value-added tax. If no separate agreement is in place, the prices shall not include transportation and delivery costs, packaging costs, insurance, customs duties, etc. (EX WORKS, Incoterms 2010). No delivery fees shall be charged for the normal delivery of goods with a value in excess of CHF 600.

3.2 Invoices shall be payable within 30 days of the invoice date (strictly net). The payment shall only be deemed to have been made once REGEDENT can dispose of the respective amount (receipt of payment).

3.3 Should the client be culpable for falling into default with the acceptance of the delivery items or the payment of the purchase price, REGEDENT may – if legally required – withdraw from the agreement following the expiry of an appropriate grace period and demand compensation instead of performance.

3.4 Bills of exchange and cheques shall only be accepted for processing and shall first be deemed to constitute payment upon being credited unconditionally. Any related costs incurred shall be borne by the client.

3.5 With regard to claims from REGEDENT, the client can only assert its right of retention if it is based on claims which are uncontested, ready for decision or legally effective and which arise from the same contractual relationship. The client may only offset claims against its own claims that are undisputed, ready for decision or legally effective.

4. Partial performance, delivery time, force majeure, self-delivery, default in delivery, transfer of risk, delivery, transport insurance

4.1 REGEDENT shall be entitled to make partial deliveries provided that this is not unacceptable to the client.

4.2 Delivery times and deadlines shall only be deemed to be binding if expressly laid down in writing upon conclusion of the respective agreement. Delivery times and deadlines shall be deemed to have been adhered to if, prior to their expiry, the product to be delivered has left the REGEDENT plant or warehouse or notification that it is ready to be dispatched has been provided.

4.3 In the event of force majeure or other unforeseeable circumstances beyond the control of REGEDENT (e.g. disruptions to operations, legal strikes, lock-outs, war, import and export embargoes, shortages of energy and raw materials and official measures) which temporarily hinder it from delivering the products in accordance with the agreed delivery dates or deadlines, these delivery dates and deadlines shall be extended – including during the period of delay – by the period of time that performance is impaired as a result of these circumstances. Should a disruption of this kind last longer than three months, both parties shall be entitled to withdraw from the agreement. This shall not affect any statutory rights of withdrawal.

4.4 Should a supplier of REGEDENT fail to make a delivery or fail to deliver on time, REGEDENT shall not be deemed to be in default vis-à-vis the client provided that REGEDENT is in no way accountable for the failed or late delivery. REGEDENT may withdraw from the agreement if it is clear that it will not receive the relevant supplies of the ordered goods due to circumstances beyond its control.

4.5 Should REGEDENT fall into default, the client may, in addition to the delivery itself, only demand compensation for any damages caused by the delay if REGEDENT has acted wilfully or with negligence. If REGEDENT is deemed to have acted in a slightly negligent manner, liability shall be limited to foreseeable damages typical for the respective agreement, but shall be no more than 5% of the agreed purchase price for those product parts which REGEDENT is late in delivering.

4.6 Subject to an agreement to the contrary, deliveries shall be made at the risk and expense of the client. Risk shall be transferred to the client as soon as the respective good leaves the REGEDENT plant or warehouse or, in the case of direct deliveries, the plant or warehouse of the manufacturer working on behalf of REGEDENT and upon being handed to the shipper, freight carrier or other individual entrusted with making the delivery. Should the delivery be delayed for circumstances beyond the control of REGEDENT or if the client does not accept the good on time despite the good being offered to it, risk shall be deemed to be transferred to the client upon notification being provided that the good is ready for delivery.

4.7 For deliveries, REGEDENT shall define the delivery method and the sender at its own discretion provided that no special agreements have been reached. At the client's request, REGEDENT shall conclude a transport insurance policy at the expense of the client. Any damage suffered in transit must be immediately (within five (5) days at the latest) reported to REGEDENT and the shipper responsible for the delivery.

5. Delivery and returns

5.1 The standard articles listed in the product catalogue are normally available from stock.

5.2 Provided that standard products and their original packaging are intact ("intact standard products"), these may be returned within 14 days of the invoice date against a credit note without deductions. If intact standard products are returned more than 14 days after the invoice date, a processing fee of CHF 40 shall be charged. Intact standard products which are returned more than three months after the invoice date shall only be credited up to 50%. Intact standard products returned more than six months after the invoice date shall no longer be credited. A copy of the invoice must be enclosed with each return delivery.

6. Notification of defects and liability for defects

6.1 The client shall be obligated to check the entire delivery straight away upon receipt of the good and to immediately (no later than after seven (7) days) inform REGEDENT in writing of any identified defects, including a detailed description. Hidden defects must be reported to REGEDENT immediately upon being discovered (no later than after seven (7) days).

6.2 If the client identifies externally visible damage to the delivered item upon taking delivery of the good from the transport company or notices that something is missing, it shall be the responsibility of the client to ensure that the loss or damage is certified by the transport company (notice of damage) and to immediately inform REGEDENT of this and provide it with the certificate. The same shall also apply to losses or damage which were not originally externally visible and which are subsequently discovered by the client.

6.3 Should the respective good exhibit material defects, REGEDENT shall have the option to either subsequently fulfil its obligations under the agreement by means of eliminating or remedying the defects or by delivering a new, defect-free good. If REGEDENT opts to eliminate a defect, it shall bear all necessary costs associated with the elimination of the defect (especially transport costs) unless these costs are incurred due to the delivery of the good to a different location to that of the place of performance.

6.4 If REGEDENT fails to fulfil its obligations despite at least two subsequent attempts to do so, the client shall be authorised to decide at its own discretion whether to withdraw from the agreement, request a price reduction or demand compensation for damages.

6.5 Warranty rights can only arise if the delivery item exhibits material damage upon the transfer of risk (especially poor workmanship, poor materials). Warranty rights shall not arise as a result of the inappropriate or improper use or handling of the delivery items, natural wear and tear or unsuitable usage conditions.

6.6 No defects shall be deemed to exist if the service has been provided by REGEDENT in accordance with the information provided by the client. Nor shall minor deviations constitute a defect.

6.7 The client shall only be entitled to assert claims for damages due to defects to the extent that the liability of REGEDENT is not excluded or limited in accordance with the following or other provisions. Further-reaching claims or claims other than those specified in this section shall be excluded.

6.8 The period of limitation for claims based on material damages shall be 12 months as of the transfer of benefit and risk.

6.9 Provided that the defective delivery item is a third-party product, REGEDENT shall be entitled to transfer its defect-based claims against the suppliers to the client and inform the client of the option to (legally) enforce these claims. In accordance with sections 7.1 - 7.4, a claim can only be asserted against REGEDENT if the claims against the suppliers are unenforceable despite their timely (legal) assertion.

7. Limitation of liability

7.1 REGEDENT shall only accept liability in cases of intent and gross negligence. REGEDENT shall accept no liability whatsoever for lost earnings, collateral damage, indirect damage, special damage, consequential damage or similar kinds of damage.

7.2. Should REGEDENT be called to account for a slightly negligent breach of a significant contractual obligation, its liability shall be limited to foreseeable damages typically suffered in connection with an agreement of this type. It shall accept no liability for lost earnings, collateral damage, indirect damage, special damage, consequential damage or similar kinds of damage.

7.3 In situations in which the fulfilment of the respective contractual obligation was impossible from the outset, REGEDENT shall only accept liability if it was aware of the hindrance to performance or if the fact it was unaware can be attributed to gross negligence.

7.4 The aforementioned exclusions and limitations of liability shall not apply in instances in which defects are fraudulently concealed or in cases in which a quality guarantee is provided specifying liability for claims based on the Product Liability Act and for physical injury.

7.5 Where the liability of REGEDENT is excluded or limited, this shall also apply to the personal liability of its personnel, workers, employees, representatives and agents.

7.6 With the exception of claims arising from unlawful acts, the client's claims for damages in cases for which liability is limited pursuant to this section shall lapse one year after the start of the statutory limitation period.

8. Retention of title

8.1 All goods delivered by REGEDENT shall remain the property of REGEDENT (reserved goods) until all claims of REGEDENT arising from the contractual relationship as well as any other claims which REGEDENT can assert against the client, irrespective of the legal grounds, either now or in the future (including all current account balance claims) are settled in full. This shall also apply when payments have been made on specially designated claims. With respect to current accounts, the reserved goods shall serve as security for the claims for payment of REGEDENT.

8.2 If the client discontinues its payments not only on a temporary basis, applies for the initiation of bankruptcy proceedings concerning its assets or bankruptcy proceedings are opened in connection with its assets, the client shall, at REGEDENT's request, be obligated to hand over the reserved goods still owned by REGEDENT. Furthermore, REGEDENT shall be entitled to demand the return of the reserved goods should the client act in a way that breaches the agreement, in particular in instances of payment defaults. The reclaiming of the reserved goods shall only constitute a withdrawal from the agreement if expressly declared as such by REGEDENT.

9. Place of performance, applicable law, place of jurisdiction

9.1 The place of performance for all obligations arising from the sale and delivery of our products shall be Zurich, Switzerland.

9.2 Both the basic relationship and these General Terms and Conditions shall be judged in accordance with Swiss law.

9.3 The sole place of jurisdiction for all disputes shall be the ordinary courts in Zurich, Switzerland.

June 2014, REGEDENT AG, SWITZERLAND

ASSIGNMENT OF QUALITY ASSURANCE ROLES & RESPONSIBILITIES FOR RESELLER/DENTAL DESPOSTORY

(Amendment to REGEDENT’s General Terms and Conditions)

1. REGEDENT Contact Details


REGEDENT AG
Zollikerstrasse 144
CH–8008 Zürich

Phone: +41 44 700 37 77
Fax: +41 44 700 47 97
REGEDENT GmbH
Pfarrgasse 6
DE-97337 Dettelbach

Phone: +49 9324 604 99 27
Fax: +49 9324 604 99 26


2. PRODUCT Details, including specific Storage and Transport Conditions

PRODUCT Name Article No. PRODUCT Details Storage Transport
SMARTBRANE 0121.200 10x10mm 15-30°C Keep dry. Keep away from sunlight Standard transport
SMARTBRANE 0121.201 15x20mm 15-30°C Keep dry. Keep away from sunlight Standard transport
SMARTBRANE 0121.202 20x30mm 15-30°C Keep dry. Keep away from sunlight Standard transport
SMARTBRANE 0121.203 30x40mm 15-30° Keep dry. Keep away from sunlight Standard transport
THE Graft BG-A25 0.25g/ 0.25-1mm 15-20°C Keep dry. Keep away from sunlight Standard transport
THE Graft BG-O5 0.5g/ 0.25-1mm 15-20°C Keep dry. Keep away from sunlight Standard transport
THE Graft BG-A10 1g/ 0.25-1mm 15-20°C Keep dry. Keep away from sunlight Standard transport
THE Graft BG-A20 2g/ 0.25-1mm 15-20°C Keep dry. Keep away from sunlight Standard transport
THE Graft BG-B05 0,5g/ 1-2mm 15-20°C Keep dry. Keep away from sunlight Standard transport
THE Graft BG-B10 1g/ 1-2mm 15-20°C Keep dry. Keep away from sunlight Standard transport
PERISOLV 10500 1 box of 5 units 2-8°C, well-sealed, short term (during a day) storage at room temperature Standard transport
HYADENT BS065 1 syringe (1.0 ml) 2-25°C Store in a dry place. Do not expose to direct sunlight Standard transport
HYADENT BG BS091 2 ampulla (1.2 ml each) 2-25°C Store in a dry place. Do not expose to direct sunlight Standard transport
OSOPIA 0111.101 0.5cc/ 0.25-1mm Store at ambient temperature ina dry place. Standard transport
OSOPIA 0111.102 1 cc/ 0.25-1mm Store at ambient temperature in a dry place. Standard transport


3.Definition

‘placing on the market’ means the first making available of the PRODUCTS on the market in the TERRITORY.

‘making available on the market’ means any supply of the PRODUCT, for distribution, consumption or use on the market in the TERRITORY in the course of a commercial activity, whether in return for payment or free of charge.

‘putting into service’ means the stage at which the PRODUCT has been made available to the final user as being ready for use on the market in the TERRITORY for the first time for its intended purpose.

‘manufacturer’ means a natural or legal person who manufactures the PRODUCT and markets that PRODUCT under its name or trademark.

‘third party manufacturer’ is the manufacturer of the PRODUCT licensed by REGEDENT for distribution in the countries of the TERRITORY.

‘DISTRIBUTOR’ means any natural or legal person in the supply chain, other than the manufacturer, that makes the PRODUCT available on the market in the TERRITORY, up until the point of putting into service.

‘authorised representative’ means any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer's behalf in relation to specified tasks with regard to the latter's obligations under this Regulation. NOTE: Eventually indicated on the packaging of the PRODUCT.

‘importer’ means any natural or legal person established within the European Union that places a device from a third country on the European Union market NOTE: Eventually indicated on the packaging of the PRODUCT.

‘notified body’ means a conformity assessment body designated in accordance with the European regulation.

‘Unique Device Identifier’ (‘UDI’) means a series of numeric or alphanumeric characters that is created through internationally accepted device identification and coding standards and that allows unambiguous identification of specific devices on the market.

‘user’ means any healthcare professional (such as, but not limited to the dental practitioner) or lay person who uses a PRODUCT.

‘post-market surveillance’ means all activities carried out to institute and keep up to date a systematic procedure to proactively collect and review experience gained from PRODUCTS placed on the market, made available on the market or put into service for the purpose of identifying any need to without delay apply any necessary corrective or preventive action.

‘Non-conformity’ means a difference between the observed characteristic/ value and the reference characteristic/ value

‘incident’ means any malfunction or deterioration in the characteristics or performance of a PRODUCT made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect.

‘adverse event’ means any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory finding, in subjects, users or other persons.


4.Regulatory

REGEDENT shall license the applicable PRODUCTS from third party manufacturer for distribution in the countries of the TERRITORY.

REGEDENT shall request available objective evidence needed for PRODUCT registration or registration approval/ certificate from third party manufacturer requested by the competent authorities from the countries of TERRITORY.

REGEDENT shall notify DISTRIBUTOR, when these licenses, regulatory approvals or certificates are revoked.

REGEDENT or the third party manufacturer shall provide to DISTRIBUTOR the objective evidence, in order that the DISTRIBUTOR is able to fulfill the obligation to act with due care in relation to the requirements applicable in the TERRITORY, when making the PRODUCT available on the market.

(a) the applicable EU declaration of conformity and the applicable CE Certificate of the PRODUCT

(b) the information (e.g. instructions for use, labels) on the PRODUCT to be supplied

(c) the contact details of the importer (if the DISTRIBUTOR does not act as importer) and

(d) the Unique Device Identification (UDI) assigned to the PRODUCT

(e) the certification of REGEDENT’s or the third party manufacturer’s quality management system.

When making the PRODUCT available on the market, the DISTRIBUTOR shall, in the context of their activities, act with due care in relation to the regulatory requirements applicable in the TERRITORY and is responsible for registering the PRODUCT with competent authorities in all countries in the TERRITORY.

Before making the PRODUCT available on the market in the TERRITORY, DISTRIBUTOR shall verify that all of the following requirements are met:

-the PRODUCT fulfills the regulatory requirements applicable in the country of the TERRITORY, where the PRODUCT is made available on the market (e.g. CE mark and EU declaration of conformity of the device drawn up)

-the PRODUCT is accompanied by the information (e.g. instructions for use, labels) in accordance with the regulatory requirements applicable in the country of the TERRITORY, where the PRODUCT is made available on the market

-for imported PRODUCTS, the importer has complied with the regulatory requirements applicable in the country of the TERRITORY, where the PRODUCT is made available on the market

-that, where applicable, a Unique Device Identification (UDI) has been assigned to the PRODUCT


5.Quality Management

REGEDENT and/ or DISTRIBUTOR shall establish and maintain an appropriate quality management system in compliance with applicable laws, regulations and standards to ensure the level of quality is maintained while performing the activities relevant for the quality assurance of the PRODUCT.

DISTRIBUTOR shall ensure that quality records and information relevant for the quality assurance of the PRODUCT are created, stored, and managed using proper protection and allowing for future access during a retention time of at least 15 years.

Upon agreement termination, DISTRIBUTOR shall ensure that critical data and records as described in this Quality Assurance Agreement remain available during the retention time or are transferred to REGEDENT.


6.Resource Management

REGEDENT shall ensure to have appropriate resources (such as, but not limited to human resource and infrastructure) to fulfill obligations of this agreement.

REGEDENT is responsible to provide information and training on the PRODUCT to the DISTRIBUTOR.

DISTRIBUTOR shall ensure to have appropriate resources (such as, but not limited to human resource and infrastructure) to fulfill obligations of this agreement.

DISTRIBUTOR is responsible that personnel involved in making the PRODUCT available on the market is suitably qualified, by education, training or experience in the relevant medical field to perform their tasks in conformance with the regulatory requirements applicable in the countries of the TERRITORY.

DISTRIBUTOR is responsible for the instruction and training of the user on the PRODUCT through its personnel.

DISTRIBUTOR shall maintain and provide to REGEDENT, upon request, an organizational chart as well as the competences which are required for each person involved in making the PRODUCT available on the market as well as the quality management representative and the responsible person for regulatory affairs: position description, training plan and training records.


7.Design Control

(including Labeling, Promotional & Sales and Training Material, Conformity Assessment, Registration of Device/ Economic Operators)

REGEDENT or third party manufacturer shall be solely responsible for the design of the PRODUCT including PRODUCT packaging and accompanying information and any translation thereof.

Changes to the design of the PRODUCT are notified to the DISTRIBUTOR in due time.

REGEDENT or third party manufacturer shall ensure that the PRODUCT is accompanied by the information in accordance with regulatory requirements applicable in the TERRITORY in (an) official language(s) of the countries in TERRITORY in which the PRODUCT is made available to the user. The particulars on the label shall be indelible, easily legible and clearly comprehensible to the intended user.

REGEDENT or third party manufacturer provides available labelling, promotional & sales and training material in English language to the DISTRIBUTOR for translation to official language(s) of the countries in the TERRITORY.

REGEDENT provides specimens or print file of the labelling, promotional & sales and training material in the official language(s) of the countries in the TERRITORY.

It is REGEDENT’s or third party manufacturer’s obligation to:

-to review and approve any alterations to the labeling, promotional & sales and training material (including establishment of new material) of the PRODUCT proposed by the DISTRIBUTOR within 14 days prior to making available on the market

-to justify any rejection of the alteration proposed by the DISTRIBUTOR

REGEDENT or third party manufacturer shall register (changes to) manufacturer, authorised representative and importer by submission to the electronic system before placing the PRODUCT on the market.

REGEDENT or third party manufacturer shall confirm data of (changes to) manufacturer, authorised representative and importers submitted to the electronic system for registration of economic operators on a yearly basis.

DISTRIBUTOR shall indicate to REGEDENT or third party manufacturer special requirements to the information that the PRODUCT is accompanied with in accordance with regulatory requirements applicable in each of the countries in the TERRITORY in which the PRODUCT is made available by the DISTRIBUTOR to the user.

DISTRIBUTOR identifies official language(s) of each of the countries in their TERRITORY

DISTRIBUTOR provides translation of labelling, promotional & sales and training material to official language(s) of the countries in the TERRITORY, including a confirmation that translation is accurate and up-to-date. It is the DISTRIBUTOR’s obligation to:

-to submit in English language any planned alterations to the labeling, promotional & sales and training material (including establishment of new material) of the PRODUCT to REGEDENT at least 14 days prior to making available on the marketand

-to assure to have obtained the written approval by REGEDENT of the alterations to the labeling (including packaging), promotional & sales and training material before making available on the market

DISTRIBUTOR is not allowed to do any of the following:

-making available on the market a PRODUCT under its name, registered trade name or registered trade mark

-changing the intended purpose of a PRODUCT already placed on the market or put into service;

-modifying the primary packaging, the label and instructions for use of a PRODUCT supplied by REGEDENT or third party manufacturer and

-modifying (including repackaging and relabeling) a PRODUCT already placed on the market or put into service in such a way that compliance with the applicable requirements may be affected.

DISTRIBUTOR shall provide

-the information supplied by REGEDENT relating to a PRODUCT already placed on the market and

-of further information in alignment with the information supplied by REGEDENT which is necessary in order to market the PRODUCT in the TERRITORY

DISTRIBUTOR shall maintain a register according to national provisions in all the countries of the TERRITORY applicable.


8.Identification and Traceability

REGEDENT or the third party manufacturer shall maintain a system to assure proper identification and acceptance status of materials, components and PRODUCTS throughout the manufacturing cycle and records to allow for traceability of materials & components used in a particular lot or batch of finished PRODUCTS.

REGEDENT shall store and keep, preferably by electronic means, the Unique Device Identifier (UDI) of the PRODUCTS which they have supplied to the DISTRIBUTOR.

REGEDENT and/ or third party manufacturer shall trace the PRODUCT supplied to the DISTRIBUTOR.

DISTRIBUTOR shall establish processes and take adequate measures to guarantee complete traceability for PRODUCTS from the time of receipt of PRODUCTS from REGEDENT up to delivery to the user who puts the PRODUCT into service.

DISTRIBUTOR is responsible to identify and/ or clearly mark PRODUCTS (e.g. by attaching a sticker “not for human use”) which are not to be used in humans (such as, but not limited to the use for training/ demonstration purposes).

DISTRIBUTOR shall store and keep continuously updated records of PRODUCTS sold, indicating the PRODUCT’s name and article number, batch number, expiry date as well as the contact details of the recipient who acquired the product, the number of the PRODUCTS shipped and the date of transition to the recipient.

DISTRIBUTOR shall store and keep, preferably by electronic means, the Unique Device Identifier (UDI) of the PRODUCTS which they have supplied or with which they have been supplied.

At termination of the contract - be it for regular expiry, cancellation, or discontinuance of DISTRIBUTOR’s business, or any other reason - REGEDENT must dispose of the data mentioned in the phrase above. REGEDENT will not use these data for other reasons than traceability unless other agreements are closed between REGEDENT and DISTRIBUTOR.

DISTRIBUTOR obligated to assure traceability of PRODUCTS according to the requirements of the European authorities (for the time being: 30 years after delivery for allogenic products, 15 years for other products) and – if applicable – of the authorities of TERRITORY.

9.Product Maintenance (Storage & Transportation)

DISTRIBUTOR shall ensure that, while the PRODUCT is under their responsibility, storage or transport conditions comply with the conditions set for each PRODUCT.

PRODUCTS for which the storage and transport conditions according to the specified requirements were not fulfilled are non-conforming products and need to be handled in accordance with the non-conformity management requirements.

DISTRIBUTOR shall ensure that the date of expiry of sterile PRODUCT is suitable for the user requirements (this applies also to consignment goods). This means that the DISTRIBUTOR shall ensure that PRODUCTS are sold, or, if on consignment, returned to the DISTRIBUTOR, before the PRODUCT’s date of expiry.

DISTRIBUTOR shall inform REGEDENT about any third party products, which are sold with the intention of being used in combination with PRODUCT’s prior to its first use. This information shall contain documentation describing the relevant products (e.g.: drawings, samples, brochures etc.). REGEDENT or third party manufacturer does not assume any responsibility for the use with third party products unless expressly agreed in writing.


10.Post Market Surveillance

The DISTRIBUTOR is obliged to ensure that the users buying the products are aware of the PRODUCT specific instructions for use and get updated versions of the instructions as necessary and appropriate.

DISTRIBUTOR shall cooperate with REGEDENT to collect and provide information on feedback and complaints provided by user.


11.Complaint Handling and Vigilance

REGEDENT or the third party manufacturer shall carry out an evaluation of the PRODUCTS suspected of presenting an unacceptable risk or other non-compliance.

REGEDENT or the third party manufacturer shall ensure that the necessary action to bring that PRODUCT into conformity, to withdraw or to recall it, as appropriate, is taken.

REGEDENT and/ or third party manufacturer shall cooperate with DISTRIBUTOR to enable cooperation with competent authorities of a country in the TERRITORY, upon request, on any action taken to eliminate the risks posed by PRODUCTS which they have made available on the market

DISTRIBUTOR that has received complaints or reports from any subjects, users or other persons about suspected incidents and/ or adverse events related to a PRODUCT DISTRIBUTOR has made available, shall without undue delay forward this information to REGEDENT.

DISTRIBUTOR shall cooperate with REGEDENT and/ or third party manufacturer, the Notified Bodies and competent authorities to carry out an evaluation of the PRODUCTS suspected of presenting an unacceptable risk or other non-compliance and to provide available complaint product to REGEDENT and/ or third party manufacturer.

DISTRIBUTOR shall cooperate with the REGEDENT and/ or third party manufacturer, the Notified Bodies and the competent authorities to ensure that the necessary action to bring that PRODUCT into conformity, to withdraw or to recall it, as appropriate, is taken.

Where the DISTRIBUTOR considers or has reason to believe that the PRODUCT presents a serious risk, the DISTRIBUTOR shall also immediately inform the competent authorities of the country in the TERRITORY in which the DISTRIBUTOR made the PRODUCT available, giving details, in particular, of the non-compliance and of any action taken.

In case the DISTRIBUTOR is obliged to file a report in relation to the PRODUCTS with the competent authorities in the TERRITORY, DISTRIBUTOR shall provide REGEDENT and/ or third party manufacturer with a copy of its report prior to or, if no prior provision is legally permissible, contemporaneously with its submittal to the appropriate authority.

DISTRIBUTOR shall immediately (within 24 hours) inform REGEDENT and/ or third party manufacturer in case of field safety notices affecting the PRODUCTS in the TERRITORY.

DISTRIBUTOR shall keep a register of complaints, recalls and withdrawals, and keep REGEDENT informed of such monitoring and provide them with any information upon their request.

In the event of an inquiry by the competent authorities, copies of individual complaint reports or complaint summaries are available in written from DISTRIBUTOR during regular business hours.


12.Audit and Inspections

DISTRIBUTOR shall allow REGEDENT or third party manufacturer to conduct audits at the DISTRIBUTOR (during regular working hours) to verify its compliance to the requirements and obligations agreed on and to applicable laws and regulations after prior written notification of 60 days.

DISTRIBUTOR shall allow and support unannounced inspections by Notified Body of REGEDENT or third party manufacturer and/ or competent authorities.

REGEDENT shall communicate the results of the audit by means of an audit report or excerpts thereof.

DISTRIBUTOR shall notify REGEDENT immediately (within 24 hours), when inspections by Notified Body of REGEDENT or third party manufacturer and/ or the competent authorities are scheduled or occur.

DISTRIBUTOR shall notify REGEDENT immediately (within 24 hours), when a warning letter or other significant observation/ regulatory citation from the Notified Body of REGEDENT or of third party manufacturer and/ or the competent authorities is received.

DISTRIBUTOR shall communicate the results of the inspections by Notified Body of REGEDENT or third party manufacturer and/ or the competent authorities to REGEDENT immediately (within 24 hours) in case of significant observation or within 10 business days in case of any other observations.

DISTRIBUTOR shall plan and execute activities to remediate audit observations made during these audits and inspections.

The plan of the activities shall be shared with REGEDENT within the timeframe indicated in the audit/ inspection report.


13.Non-Conformity Management (including control of non-conforming product, rework)

Where the REGEDENT or third party manufacturer considers or has reason to believe that a PRODUCT is not in conformity with the applicable regulatory requirements, REGEDENT or third party manufacturer shall inform DISTRIBUTOR of the (potential) non-conformity.

REGEDENT or the third party manufacturer shall carry out an evaluation of the PRODUCTS suspected of presenting non-compliance.

REGEDENT or the third party manufacturer shall ensure that the necessary action to bring that PRODUCT into conformity, to withdraw or to recall it, as appropriate, is taken.

REGEDENT or third party manufacturer shall cooperate with DISTRIBUTOR to inform competent authorities in the countries of the TERRITORY, in which the DISTRIBUTOR has made the (potential) non-conforming PRODUCT available on the market.

Where the DISTRIBUTOR considers or has reason to believe that a PRODUCT (including goods returned) is not in conformity with the regulatory requirements, the DISTRIBUTOR shall not make the PRODUCT available on the market, until it has been brought into conformity.

The DISTRIBUTOR shall immediately (within 24 hours) inform REGEDENT and/ or third party manufacturer of the (potential) non-conformity identified and the actions taken to prevent making the PRODUCT available on the market.

DISTRIBUTOR that considers or has reason to believe that a PRODUCT which they have made available on the market is not in conformity with the applicable regulatory requirements, the DISTRIBUTOR shall immediately (within 24 hours) inform REGEDENT and/ or legal manufacturer giving details, in particular, of the (potential) non-conformance and of any action taken.

Where the DISTRIBUTOR considers or has reason to believe that the PRODUCT presents a serious risk or is a falsified PRODUCT, the DISTRIBUTOR shall inform the competent authority in the TERRITORY in which the DISTRIBUTOR is established.

The DISTRIBUTOR shall immediately (within 24 hours) inform REGEDENT of any report made to the competent authorities.

DISTRIBUTOR shall cooperate with REGEDENT or third party manufacturer to carry out an evaluation of the PRODUCTS suspected of presenting an unacceptable risk or other non-compliance and to provide available non-conforming product to REGEDENT or third party manufacturer.

DISTRIBUTOR shall take without delay all appropriate and duly justified action assigned to by REGEDENT or third party manufacturer to bring the PRODUCT into compliance relating to the risk presented by the PRODUCT and in a manner that is proportionate to the nature of the risk.

DISTRIBUTOR shall cooperate with REGEDENT or third party manufacturer to inform competent authorities in the countries of the TERRITORY, in which the (potential) non-conforming PRODUCT has been made available on the market.

DISTRIBUTOR is responsible to identify, clearly mark (e.g. by labeling PRODUCTS “non-conforming product”), separate and quarantine PRODUCTS which are not to be used in human (such as, but not limited to a deviation in transport and storage or to a (potential) product non-conformity, which were only noticed and communicated after the PRODUCTS were delivered to DISTRIBUTOR).

DISTRIBUTOR shall keep a register of (potential) non-conforming PRODUCTS and of actions taken, and keep REGEDENT informed of such monitoring and provide REGEDENT or third party manufacturer with any information upon their request.

In the event of an inquiry by the competent authorities, copies of individual non-conformity reports or non-conformity summaries are available in written from DISTRIBUTOR during regular business hours.


14.Corrective Action and Preventive Action

REGEDENT or the third party manufacturer shall ensure that the necessary corrective and preventive actions to bring or keep the PRODUCT in compliance relating to the risk presented by the PRODUCT and in a manner that is proportionate to the nature of the risk are taken.

DISTRIBUTOR shall take without delay all appropriate and duly justified corrective action assigned to by REGEDENT or third party manufacturer to bring the PRODUCT into compliance relating to the risk presented by the PRODUCT and in a manner that is proportionate to the nature of the risk.

DISTRIBUTOR shall take all appropriate and duly justified preventive action assigned to by REGEDENT or third party manufacturer to prevent a potential non-conformance of PRODUCT relating to the potential risk presented by the PRODUCT and, in a manner that is proportionate to the nature of the risk.

DISTRIBUTOR shall keep a register of actions taken and provide REGEDENT or third party manufacturer with any information upon their request.