Representative Mandate Contract

This agreement is entered into between QS Experts (hereinafter referred to as "Representative") and the Manufacturer as identified in the application form (hereinafter referred to as "Manufacturer").

1. Administrational provision

1.1 Basis of contract

The selected mandate(s) shall be executed in accordance with the applicable regulatory framework of the designated area. Both parties agree to comply with the requirements and regulations and to fulfil these obligations to the best of their knowledge and ability:

1.2 Representative Registration

QS Experts AG serves as the Manufacturer's sole contractual partner and point of contact for the selected mandates. Due to regulatory requirements, the registration as CH-REP, EU-REP and UKRP is processed through the following local partners and must be shown on the product label as the official registered representative:

1.3 Start of contract and minimum term

This contract begins on the date this contract is issued. It is only valid after both parties accepted this contract and the initial payment for the annual fee is received by the Representative. Minimum term is 2 years.

2. Compensation & Terms of payment

1. All fees are based on the attached price list and may be changed on annual basis. Within the minimum term of this contract no price increase can be applied by the Representative.
2. Payment not received within 30 days after due date of the invoice will be subject to a late payment fee of CHF 50. Invoices that are not paid within 60 days after due date of the Invoice will lead to a suspension of the mandate as Representative. A reactivation of the mandate leads to additional costs of CHF 200.
3. Annual service fees are payable in advance for a full year. Fees for product review, registrations, incident processing, etc. are charged by task according to expenditure.
4. Neither party may write off the debts of the other party to balance the accounts of both, unless expressly agreed to in writing.

3. Duties, Powers and Responsibilities

3.1 Manufacturer

1. The Manufacturer declares that QS Experts is designated as the sole representative for the applied product families and mandates.
2. The Manufacturer provides QS Experts with all relevant information, documentation and instructions regarding incident reports, monitoring procedures, inspection procedures, conformity assessment procedures, as well as updates to such data, so that QS Experts can cooperate with the market surveillance authorities and, where appropriate, submit a report in accordance with the Regulation.
3. The Manufacturer shall inform QS Experts of all incidents in a timely manner as soon as they become known.
4. Products with modifications will be treated as new products, if such changes could affect the safety and performance of the device or the conditions prescribed for use of the device.
5. In case the Manufacturer does not appoint QS Experts as his PRRC, the client shall ensure that at least one person responsible for regulatory compliance is permanently and continuously available to the Representative who has the necessary expertise regarding the regulatory requirements for medical devices.

3.2 Representative

6. The Representative will provide the competent authorities with a copy of the mandate upon request.
7. The Representative verify that the EU declaration of conformity and technical documentation have been drawn up and, if so, that an appropriate conformity assessment procedure has been carried out by the manufacturer.
8. The Representative cooperate with the competent authorities in all preventive or corrective measures to eliminate or, if this is not possible, to mitigate the risks posed by the products.
9. The Representative ensures that the manufacturer, and if applicable the products, are registered at the competent authority.
10. QS Experts roles and responsibilities are limited the mandates defined in this Agreement and as such is not responsible for the design, manufacture, packaging and labelling of a product. QS Experts do not affix the CE marking to the manufacturer's product, nor is it responsible for placing the manufacturer's product on the market.

4. Terms & Conditions

4.1 Confidentiality

All information and documentation exchanged between the parties is confidential and remains the property of the disclosing party. Such information may only be used for the performance of this Agreement and disclosed solely to personnel bound by equivalent confidentiality obligations on a need-to-know basis. Mandatory disclosure to third parties requires that the third party is bound by strict confidentiality. These obligations continue after termination of this Agreement.

4.2 Indemnification, Indemnity & Insurance

1. The client agrees to indemnify and hold QS Experts, including its directors and employees, harmless from third-party claims, losses, damages, fines, penalties, costs and expenses (including reasonable attorneys' fees) arising from or related to the client's products or any related regulatory or product-liability claims, except were resulting from QS Experts' gross negligence or willful misconduct.
2. This indemnification applies from the effective date, remains valid for fifteen (15) years after termination, and survives such termination.
3. Upon execution of this agreement, the client shall add QS Experts as covered party under its product liability insurance and provide QS Experts with written confirmation from the insurer approving the insurance and indemnification clause. If such coverage is not granted, QS Experts will obtain its own product liability insurance, which will result in an additional annual fee according to the price list.

4.3 Product Placement on the market and Restriction of the mandate

1. Acceptance of this contract does not imply that the product will be placed on the market or put into service.
2. Any application to review and register any products must be submitted by the Product Application Form and the applicable documents shown on this form. Product applications are subject to fees as shown on the price list.
3. The manufacturer may not place any product on the market until the review of the applied products has been approved or temporarily approved by the Representative.
4. The mandate as a Representative only includes products that have been reviewed and approved by QS Experts. The approval will be given by a review report after submission of all requested documents and can be renewed on regular intervals during the annual document inspection. All products that are reviewed and approved are listed in the Document "Summary of Registration". Products that are not listed in the "Summary of Registration" are not covered under the mandate as a Representative.
5. An application for the release of a product does not imply approval and therefore does not fall under the mandate.
6. In case of non-conformities during the annual review that leads to a rejection of the approval, the product family will be automatically excluded from the approved scope of products and is no longer under the mandate as a Representative.
7. In the case of temporary approval, the mandate for these products will automatically expire without further notice after the deadline if no correcting actions have been taken and the product family has become a final approval from QS Experts.

4.4 Termination of the agreement

1. After the minimum period, this Agreement may be terminated by either party with written notice, 60 days prior to the end of each annual renewal period. The termination will only take effect when all legal requirements for the modification of the approval by the manufacturer have been met. Both parties must continue to comply with the terms of the Agreement during this notice period.
2. This Agreement may be terminated by written notice of termination effective immediately in case of insolvency, bankruptcy or settlement proceedings or any other procedure for the satisfaction of claims is opened by the manufacturer or the representative or in the event of dissolution or discontinuation of the services of QS Experts.
3. In the event of a clear non-compliance by the manufacturer violating national law and if the manufacturer does not take corrective action within 30 days, QS Experts reserves the right to either freeze or terminate this agreement.

5. Final provisions

1. Failure to enforce any provision of the Agreement shall not constitute a waiver of such provision nor shall it affect the parties' right to enforce such provision later. It is also pointed out that the invalidity of individual provisions of the contract does not invalidate the remaining provisions of this contract.
2. Neither party shall be entitled to enter any obligations on behalf of the other party without prior written consent.
3. The understanding and execution of the contract shall be governed exclusively by the Swiss legal system; if individual provisions are invalid or null and void, they will be replaced by a similar, legally valid formulation. The place of fulfilment and jurisdiction for all obligations and rights arising from this contract is the registered office of QS Experts AG in Switzerland.