General Terms & Conditions
Version April 2025
1. Introduction
These General Terms and Conditions (GTC) are an integral part of the accepted Statement of Work (SoW) between the parties. They are communicated with each quote and invoice. Changes can only be made in writing with the agreement of QLE Group BV.
These terms and conditions are an integral and unconditional part of the SoW between the parties and apply ne varietur when signing the SoW in addition to other terms and conditions.
2. Order and obligations
QLE Group BV undertakes to provide advice and services to clients in the medical device sector. QLE Group BV shall perform the assignment to the best of its knowledge and ability and with the care and diligence reasonably expected from a professional service provider active in the medical device sector. QLE Group BV provides its services under a best-efforts obligation ("obligation de moyens") and does not guarantee any specific result, including but not limited to regulatory approval, certification, market access, or acceptance by any competent authority or notified body.
QLE Group BV makes no warranties or representations in connection with these General Terms and Conditions or any specific SoW or the services provided hereunder and disclaims all other warranties, including, without limitation, merchantability, quality, acceptance by any regulatory authority, fitness for a particular purpose or use, title and non-infringement and any warranties arising from course of performance, course of dealing or usage or trade. Client acknowledges that services are of a research and development nature, and as such, are provided on an “as is” basis. QLE makes no representations or warranties about the results of the services, nor does it make any representations or warranties about the legality or propriety of the use of the services for any specific purpose.
The validity of a proposal is 60 days from the proposal date.
3. Place of service
The services by QLE Group BV are performed at the address communicated by the Client, to which access is ensured by the Client, unless the services can be performed in QLE Group BV's offices.
4. Order
Any order that is transferred to us will only be considered accepted after our written confirmation.
The Client has the right to make changes during the performance of the assignment, to request additional work and/or to demand a revision or modification of work to be performed, when the following conditions are met:
Ø The Client will first notify QLE Group BV in writing of any request or intention to change.
Ø QLE Group BV will inform the Client in writing as soon as possible about the consequences of the requested change, as well as of the associated additional compensation to QLE Group BV and the timelines for the execution of the assignment.
Ø As long as QLE Group BV did not receive the explicit written approval by the Client regarding the order for modification as well as the additional compensation and timelines, QLE Group BV is not obliged to carry out the changes. If no agreement is reached between the Parties, QLE Group BV is entitled to carry out the original assignment.
5. Complaints
The Client shall examine the Deliverables and invoices without undue delay upon receipt.
Any complaint relating to apparent defects, non-conformity, or invoicing must be notified to QLE Group BV in writing within eight (8) calendar days from the date of delivery of the Deliverables or invoice.
Complaints relating to hidden defects must be notified in writing within eight (8) calendar days from the date on which the Client discovered or reasonably should have discovered the defect, and in any event no later than six (6) months after delivery of the relevant services.
In the absence of a timely and substantiated written complaint, the services and invoices shall be deemed definitively accepted.
Filing a complaint does not suspend the Client’s payment obligations.
6. Terms
The stated implementation terms are purely indicative (estimations). Exceeding these terms can under no circumstances be considered as a contractual error by QLE Group BV, nor give rise to cancellation of the SoW nor a fine and/or compensation.
In the event of a delay due to force majeure, QLE Group BV will be relieved of any liability.
7. Intellectual Property
All methodologies, templates, tools, know-how, and pre-existing materials developed or owned by QLE Group BV prior to or outside the scope of a specific SoW (“Background IP”) shall remain the exclusive property of QLE Group BV.
Subject to full payment of all amounts due, QLE Group BV assigns to the Client the intellectual property rights in the specific Deliverables created exclusively for the Client under the relevant SoW (“Foreground IP”).
QLE Group BV retains the right to reuse its general knowledge, experience, methodologies, templates, and non-confidential learnings acquired during the performance of the services.
Until full payment has been received, QLE Group BV retains title to the Deliverables.
8. Confidentiality
During the term of the SoW and after termination thereof, QLE Group BV will, subject to the agreement of the Client, consider all Confidential Information obtained from the Client and from third parties in the context of the execution of the Assignment as confidential, and will not notify this information to third parties unless QLE Group BV would be obliged to do so by virtue of legal, regulatory or deontological rules.
QLE Group BV takes all necessary measures to ensure that its employees and subcontractors, if any, are bound by the same obligation of confidentiality.
9. Data Protection
Each Party shall comply with all applicable data protection and privacy legislation, including Regulation (EU) 2016/679 (General Data Protection Regulation – GDPR).
To the extent QLE Group BV processes personal data on behalf of the Client, such processing shall be governed by a separate Data Processing Agreement (DPA), which shall form an integral part of the SoW.
In the absence of a separate DPA, QLE Group BV acts as an independent data controller for data processed in the context of its professional advisory services.
QLE Group BV shall implement appropriate technical and organizational measures to protect personal data against unauthorized or unlawful processing and accidental loss, destruction, or damage.
10. Fees and expenses
By default, QLE Group BV charges for the time spent on the matter. The current hourly rates may be explained and accounted for upon acceptance of a project.
Our fees are normally determined on the basis of number of factors e.g. (i) the time spent on the matter; (ii) the type of complexity; (iii) the knowledge, skills, experience required; (iv) your benefit through our work. Our hourly rates may be subject to revisions during the current time of engagement.
QLE Group BV may adjust its hourly rates annually on 1 January of each year in accordance with the evolution of the Producer Price Index (PPI) and/or Services Producer Price Index (SPPI) as published by the National Bank of Belgium (NBB) or Statbel.
The adjustment shall be calculated as follows:
New Rate = Current Rate × (New Index / Reference Index),
where the Reference Index is the index applicable at the date of acceptance of the relevant SoW.
Any other modification of rates during the execution of a SoW shall only apply after written notice to the Client at least thirty (30) days in advance.
If the adjustment exceeds ten percent (10%) within a twelve-month period, the Client shall have the right to terminate the affected SoW within fifteen (15) days after notification, without penalty, for the unperformed portion of the services.
11. Payment
The services performed by QLE Group BV are payable by the Client at the registered office of QLE Group BV thirty (30) days from the date of the invoice.
If no payment is obtained or if payment is not performed by the due date, it is explicitly agreed that, without prior notice of default, a flat-rate and irreducible increase by the Client is due, at the rate of 15% of the invoice amount with a minimum of 250€. In addition, without further notice, an interest at the rate of 1% per month on the invoice amount is due from the due date until the day of full payment.
QLE Group BV may suspend services in case of overdue payment
Recovery costs (e.g. - not exhaustive - exchange costs, currency conversion, bank and return costs) are borne by the Client. Any separate agreement e.g. deferral of exchange or assignment of debt does not imply debt renewal.
Unless explicitly stipulated, travel costs, transport and insurance costs are not included in QLE Group BV’s fees.
12. Language
These General Terms and Conditions and any SoW issued by QLE Group BV shall be drafted and interpreted exclusively in the English language. In case of translation, the English version shall prevail.
13. Amendments to an SoW
Any amendment or modification of an accepted SoW shall only be valid if made in writing and signed by duly authorized representatives of both Parties.
No email exchange, course of conduct, or informal communication shall constitute a binding amendment unless expressly confirmed in writing as such.
For the avoidance of doubt, modifications to these General Terms and Conditions are governed exclusively by the clause entitled “Modification of the General Terms and Conditions”.
14. Liability
To the fullest extent permitted by applicable law, QLE Group BV shall not be liable for any indirect, incidental, consequential, special or punitive damages, including but not limited to loss of profit, loss of revenue, loss of business opportunity, loss of goodwill, or wasted expenditure, arising out of or in connection with the services, any Statement of Work (SoW), or these General Terms and Conditions, even if such damages were foreseeable.
Except in cases of wilful misconduct or where liability cannot be limited or excluded under mandatory law, the total aggregate liability of QLE Group BV arising out of or in connection with a specific SoW shall be limited to the total fees actually paid by the Client under the relevant SoW giving rise to the claim. For the avoidance of doubt, the liability cap applies in the aggregate to all claims arising under a specific SoW, regardless of the legal basis of the claim.
QLE Group BV’s liability shall be reduced by any amount obtained by the Client under any insurance policy or other indemnity covering the same damage.
If QLE Group BV is liable together with other advisers or third parties, its liability shall be limited to its proportionate share of responsibility, and in any event shall not exceed the liability cap set out above.
QLE Group BV assumes no liability for the acts, omissions, advice or services of third-party advisers or professionals, whether engaged by QLE Group BV or by the Client, unless expressly agreed otherwise in writing.
QLE Group BV assumes no liability for product defects, product recalls, regulatory fines, or compliance decisions taken by competent authorities or notified bodies.
The limitations set out in this clause shall survive termination or completion of the services.
15. Limitation Period
Any claim arising out of or in connection with a SoW, the services, or these General Terms and Conditions must be brought within twelve (12) months from the date on which the Client became aware, or reasonably should have become aware, of the facts giving rise to the claim, and in any event no later than eighteen (18) months after completion of the relevant services.
After expiry of this period, all claims shall be definitively time-barred.
16. Disputes
For all disputes between the parties, the Courts of Brussels, Belgium has jurisdiction, unless QLE Group BV chooses to bring the dispute before the Court of the Client’s place of residence or to submit it to an arbitration. Belgian law shall apply in all cases.
17. Independent Contractor
QLE Group BV performs its services as an independent contractor. Nothing in these General Terms and Conditions or in any Statement of Work (SoW) shall be construed as creating a partnership, joint venture, agency, fiduciary, employment, or similar relationship between the Parties.
Neither Party has the authority to bind, represent, or assume obligations on behalf of the other Party unless expressly agreed in writing.
Each Party remains solely responsible for its own personnel, taxes, social security contributions, statutory obligations, and business operations.
18. Force Majeure
Neither Party shall be liable for any delay or failure in the performance of its obligations (except for payment obligations) resulting from circumstances beyond its reasonable control, including but not limited to acts of God, war, terrorism, civil unrest, pandemic, epidemic, fire, flood, natural disaster, labor disputes, shortages of materials or utilities, governmental measures, regulatory restrictions, cyber incidents, or delays, suspension, inaction, or refusal by regulatory authorities or notified bodies.
The affected Party shall notify the other Party in writing as soon as reasonably practicable.
If such circumstances continue for more than ninety (90) consecutive days, either Party may terminate the relevant SoW without liability, except for services already performed and amounts accrued.
19. Entire Understanding
These General Terms and Conditions together with the applicable accepted SoW constitute the complete and exclusive understanding between the Parties with respect to the services provided.
They supersede all prior discussions, negotiations, correspondence, representations, or understandings, whether oral or written.
The Client acknowledges that it has not relied upon any statement or representation not expressly included in the SoW and these General Terms and Conditions.
20. Subcontracting
QLE Group BV is entitled to subcontract all or part of its obligations arising from the underlying SoW to third parties and QLE Group BV is only obliged to inform the Client of this.
If we instruct, engage and/or work together with other advisers or third parties, any such advisers will be considered to be independent of us and we assume no responsibility or liability for recommending them to you or for advice given by them, unless we specifically agree otherwise. We do not accept responsibility for fees or expenses charged by such advisers. QLE Group BV may agree to reasonable and customary limitations of liability imposed by such third parties.
21. Modification of the General Terms and Conditions
QLE Group BV reserves the right to amend or update these General Terms and Conditions at any time.
Any revised version shall apply exclusively to Statements of Work accepted after the date of publication or communication of the revised version.
For services already ongoing under an accepted SoW, the version of the General Terms and Conditions applicable at the date of acceptance of the relevant SoW shall continue to apply, unless otherwise agreed in writing by the Parties.
The applicable version shall be the version attached to or referenced in the relevant SoW, or, failing such reference, the version in force at the date of acceptance of the SoW.
22. No Waiver
Any failure or delay by either Party in exercising any right under these General Terms and Conditions or an SoW shall not operate as a waiver of that right.
A waiver shall only be valid if expressly made in writing and shall not constitute a waiver of any subsequent breach.
23. Severability
If any provision of these General Terms and Conditions or of an SoW is held to be invalid, illegal, or unenforceable, such provision shall be deemed modified to the minimum extent necessary to render it valid and enforceable.
If such modification is not possible, the provision shall be severed and the remaining provisions shall remain in full force and effect.
The Parties agree to replace any invalid provision with a valid provision that most closely reflects the original economic and legal intent.
24. Counterparts and Electronic Acceptance
An SoW may be executed in one or more counterparts, including by electronic signature, scanned signature, or written confirmation by email.
Electronic transmission shall constitute valid and binding acceptance.
25. Survival
The provisions relating to payment, intellectual property, confidentiality, limitation of liability, non-solicitation, dispute resolution, and any other provision which by its nature is intended to survive shall remain in force after completion or termination of the services under the relevant SoW.
26. Non-Solicitation of Personnel
During the performance of the services under an SoW and for a period of one (1) year following completion thereof, the Client shall not, without prior written consent of QLE Group BV, directly or indirectly solicit, recruit, hire, or engage any employee, consultant, or subcontractor of QLE Group BV involved in the performance of the services.
This restriction shall not apply to general recruitment campaigns not specifically targeting such individuals.
In the event of breach of this clause, the Client shall owe QLE Group BV a fixed compensation of EUR 25,000 per infringement, without prejudice to QLE Group BV’s right to claim higher proven damages.
