GMED GENERAL TERMS OF SALE AND PROVISION OF SERVICES

December 2020

1. APPLICATION OF GENERAL TERMS in agreement with GMED. The Client is informed of this. This extension may lead GMED to amend the order
GMED is an independent body which performs audits, certification, all types of related services, including (planning and additional costs). GMED cannot be held responsible for anomalies and tests leading to a delay
technical and regulatory assistance, training courses and information seminars, testing,... in completing the order. Cancellation of the order by the Customer may result in the payment of
These general terms of sale and provision of services apply to all services performed by GMED, which is bound compensation for GMED in addition to the anticipated payment for the current service.
by an obligation of means. It is the Customer’s responsibility to plan with the laboratory the requirements governing storage (at least
In response to a request for services from the Customer, GMED will send a quote, comprising of a technical three (3) months), destruction, and return of samples after testing, whatever their condition (destructive
and financial proposal, which constitutes the special terms that modify or supplement these general terms of testing may render samples ineffective).
sale. For training courses and technical seminars, the special terms are attached to the registration form. 7. PERFORMANCE OF SERVICES ON SITE
2. CONFIDENTIALITY The Customer undertakes to provide GMED with means of access to the place(s) where the service is to be
GMED will not divulge any information concerning the work it is entrusted with to third parties without the performed, to the samples or equipment concerned, and to the corresponding technical documentation
prior agreement of the Customer. GMED staff are bound by contract to professional secrecy. However, required to perform the service.
GMED cannot be held responsible for the disclosure of such information if it is in the public domain, if GMED The Customer must take all necessary administrative and safety measures regarding access of GMED staff
is already privy to it, if GMED has obtained it properly from other sources, or if GMED is obliged to divulge it to the site, the conditions in which they will work, and the samples or equipment to be used in performance
to an authority pursuant to the law or the regulation or in the context of an administrative procedure or legal of the service.
proceedings. 8. TRANSMISSION AND USE OF RESULTS OF SERVICES
3. ORDERS The results of services performed by GMED are recorded in documents drawn up in French or in English on
The quote specifies the services to be performed. To place an order the Customer shall accept and GMED letterhead and bearing the Customer's name. Two copies are produced. One copy is kept in GMED's
unconditionally sign the corresponding GMED’s quote. archives and the other is sent to the Customer, unless it is replaced by an electronic copy if requested in
Placing of an order with GMED implies that the Customer has accepted these general terms of sale and any writing by the Customer.
special terms stated in the quote. Should any conflict arise with the Customer's terms of purchase or any If the Customer requests an electronic copy, GMED keeps an original, authenticated paper copy of the
other document, GMED’s terms of sale shall prevail. document sent. This document alone shall be considered authentic in the event of any dispute. GMED sends
GMED will acknowledge receipt of the Customer's order to confirm that it has accepted the order and to set the electronic copy in protected PDF format to a nominative e-mail address specified by the Customer in the
a provisional schedule for performance of the requested services. written request. These measures are taken to ensure the authenticity, integrity and confidentiality of the
GMED may refuse to perform a service when the purpose thereof appears to run contrary to GMED's aims. document sent. Documents are sent via the Internet at the Customer's risk.
GMED will supply further copies, or a copy in different format, or a copy in another language, if specifically
4. FINANCIAL TERMS AND COMPLETION TIME
requested by the Customer. This additional service will be billed.
The prices of services and billing terms are specified in GMED's quote. Prices are established on the basis
of data provided by the Customer and for normal conditions of performance of the specified service. Unless At the Customer's written request, certified true copies will be supplied, for a fee, for a period of 10 years
otherwise specified, prices quoted are exclusive of tax, transport costs and customs charges. from the date of issue of the original document.
Unless otherwise specified, the GMED quote is valid for three months from the date on which it was issued. Only original GMED documents and certified true copies shall be considered to be authentic by third parties.
Before performing a service or issuing a document as requested, GMED may require advance payment of These documents may not be modified or altered in any way. Copying of a document issued by GMED is
the total price, or a deposit, the amount of which shall be set by GMED. If the time required to perform the authorized solely on condition that it is reproduced in full. Written approval must be obtained from GMED
services exceeds one year, the prices of these services shall be increased by a minimum of 2% each year. before any other type of reference to GMED’s services may be made.
This increase shall be applied to all supplementary services which may be required by the Customer and are Any use of or reference to results and services provided by GMED that is liable to mislead consumers or
not covered in the quote. users of the product or document in question may result in prosecution, in accordance with the regulations in
Completion or delivery times specified in the quote are given as an indication only. Completion times run force. The G-MED brand and logo are the sole property of GMED. Reproduction of them in whole or in part
from the date on which the various elements required for performance of the service (order, quality is strictly prohibited and may result in prosecution, unless written agreement has been obtained from GMED.
manual(s), etc.) are received and, if applicable, the deposit specified in the quote is fully paid. If stated 9. INVOICING AND PAYMENT
completion times are exceeded the Customer shall not be entitled to cancel the order, refuse the service or Invoices are issued in the name of the Company which ordered the service, unless specifically requested by the
withhold payment, nor shall the Customer be entitled to claim compensation or damages. The sole third party. Invoices are payable in euros, by cheque.
responsibility of GMED is to inform the Customer of any operating difficulties at the appropriate time. Unless specific provisions apply, invoices are payable no later than 45 days after the end of the month in
In cases where the Customer requires the service to be performed at short notice, GMED will apply a which the invoice is issued. GMED does not apply discounts for early payment.
surcharge. In accordance with French commercial law, article L 441-6, a penalty for late payment shall be applied from
5. MODIFICATION OF THE ORDER the first day after the due date stated on the invoice. The penalty shall be equal to three times the official
The exact scope of the services to be performed is specified in the quote that once accepted by the interest rate of the current year. GMED does not issue reminders. A lump sum of forty (40) euros shall be
Customer becomes an order. Any modification of the required services occurring after the order has been added to the penalty to compensate for recovery costs. An invoice covering the penalty for late payment,
accepted must be specified in writing by the person representing the Customer and accepted by GMED. If payable on receipt, will be sent following payment of the principal. The penalty is calculated according to the
any supplementary work is agreed by both parties or proves necessary during performance of the services, date of payment of the principal.
an additional charge shall be made and completion time shall be extended.
If the quote specifies a payment schedule for the services to be performed, the schedule is drawn up taking
In cases where a date for performance of services has been agreed with the Customer, and the services into account the type of service, the timetable for its performance, and the resources required for its
cannot be performed on this date for a reason directly or indirectly attributable to the Customer, whatever the completion.
cause, GMED undertakes to implement reasonable and appropriate efforts in order to set a new date agreed
If a payment is not made by the due date as specified above, the performance of the service in question or
with the Customer taking into account GMED's existing commitments.
any other ongoing service for the Customer will be suspended and the completion schedule initially agreed
If the Company cancels or postpones a planned service 30 calendar days, or less, before the agreed service
with the Customer shall be rendered null and void. Before the service is restarted the quote shall be updated
performance date, the price of the service stated in the quote will be billed and due. All expenses already
to take the suspension into account while GMED is entitled to demand immediate full payment.
incurred to perform the service will also be due by the Customer.
Unless specific terms apply, a Customer whose registered office is outside the European Union receives a
If the Company cancels or postpones a planned service between 90 and 31 calendar days, before the
pro forma invoice and is requested to make a down payment of least 30% of the order value. However,
agreed service performance date, 50% of the price of the service stated in the quote will be billed and due.
GMED may require advance payment of the total price, or a deposit, before performing the service or issuing
All expenses already incurred to perform the service will also be due by the Customer.
a document.
6. SERVICES INVOLVING TESTING
During certification activities, including as part of an unannounced audit, GMED may decide to perform Invoices are payable by bank transfer or by cheque drawn on an account domiciled in France.
appropriate physical or laboratory testing operations on samples* from the Customer and/or suppliers and/or The Client is responsible for all services costs in furtherance of their and GMED’s regulatory responsibilities,
subcontractors of said Customer. *samples: medical device components and/or materials; adequate including interaction with regulatory and legal authorities, cancellation/reduction/withdrawal of certificate,
sample(s) of the devices produced or devices resulting from the manufacturing process, or devices placed appeal from the Company on GMED’s decision.
on the market. 10. LIABILITY
The test(s) and testing plan are determined by GMED. Unless there are specific regulatory provisions, In the event of an error shown to have been committed by GMED, GMED's liability shall be limited solely to
GMED decides on the choice of the laboratory which must be independent from the Customer. GMED can direct material loss, to the exclusion of any other indirect and/or immaterial loss, whether consequential or
ask the Customer to perform the test(s) on its premises, on the premises of its suppliers or subcontractors or not, even if the Customer gave GMED prior warning of specific risks. GMED's liability is in any case limited
in a laboratory. In the latter case, the Customer sends GMED the order placed with the selected laboratory, to the cost (excl. tax) of the service in question, irrespective of the loss incurred, to the exclusion of any other
in accordance with the testing plan. The Customer provides an estimate of the duration required for testing compensation.
and the testing report with the results. GMED analyzes the testing report and the results. 11. APPLICABLE LAW, JURISDICTION, AND VENUE
All GMED agreements and services shall be governed by and construed in accordance with the laws of
All testing-related costs are the responsibility of the Customer, and/or its suppliers and subcontractors.
France. In the event of litigation, the courts of Paris, France, shall have exclusive jurisdiction over such
GMED cannot be held liable for a delay in the progress of testing and order, in particular resulting from
litigation and all other matters, regardless of the nature thereof, including, interim measures, incidental or
payment issues between the laboratory and the Customer, and/or its suppliers and/or subcontractors.
counter-claims, multiple or third party claims, or warranty claims.
In the event of purchase by GMED of samples to perform the tests, the Customer undertakes to reimburse
GMED upon submission of the related invoice, including on behalf of its suppliers and/or subcontractors. Any In the event of any dispute, the French version alone of these General Terms of Sale and Provision of
sample shipping or reshipping costs (including customs duties, insurance, packaging costs) remain the Services shall be considered to be the authentic text.
responsibility of the Customer and/or its suppliers and/or subcontractors. 12. FORCE MAJEURE
The Customer and/or its suppliers and/or subcontractors send the samples to the laboratory. The Customer Neither Party to this Agreement shall be held responsible for any delays in the performance, or the non-
is responsible for the preparation, shipping, delivery terms, insurance and possible sample refusals/returns performance, of the obligations hereunder (other than payment of money) due to an event beyond the
by the laboratory. The Customer accepts all risks of damage or loss resulting from the transportation of Party’s reasonable control, including, but not limited to: Lock-out, strikes, wars, floods, fire, and interruption
samples, including when they are returned by the laboratory. If a sample to be tested presents a potential in the supply of energy. The occurrence of a Force Majeure event shall discharge the contractual obligations
risk, the Customer immediately informs GMED and the laboratory. Provision of such information cannot, of the Party affected by said event provided that such Party notifies the other Party within an appropriate
however, release the Customer from its liability in the event of an accident regardless of any precautions time not to exceed ten (10) days from the discovery of the Force Majeure event, at the latest. In the event
taken by the laboratory and by GMED staff to prevent the risks identified. The laboratory and/or GMED that the delay caused by Force Majeure is not remedied within 60 (60) days from the occurrence of the Force
reserves the right to refuse a test if the sample in question presents a risk to people, the environment or Majeure event, one or the other Party may then terminate the Agreement. The termination shall not affect the
property. Under no circumstances may GMED be liable for damage due to performing tests on samples, Client’s obligation to pay GMED for services already rendered.
their storage or transportation.
In the event of anomalies (samples not in accordance with the testing plan, late delivery or non-receipt of the
samples, obstacles to achieving tests, need for additional testing) the laboratory's mission may be extended

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