Lirk Nor B.V. (KvK: 42032766) Utrecht, the Netherlands
Definitions
"Lirk Nor" means Lirk Nor B.V., a private limited liability company (besloten vennootschap) incorporated under Dutch law, registered at the Chamber of Commerce under KvK number 42032766, with its registered office in Utrecht, the Netherlands. Lirk Nor B.V. is wholly owned by Lirk Nor Ventures B.V. (KvK 42030688).
"Client" means any legal entity or natural person acting in a professional or business capacity that has engaged Lirk Nor to provide Services. These General Terms and Conditions apply exclusively to B2B relationships; Lirk Nor does not contract with consumers.
“Confidential information” means any non-public information disclosed by one party to the other in connection with the Services, whether disclosed orally, in writing, or in any other form, including but not limited to: business plans, client lists, pricing, technical data, regulatory strategies, dossier content, know-how, and trade secrets. Information is Confidential Information regardless of whether it is marked as confidential at the time of disclosure.
"Agreement" means any individually signed agreement, engagement letter, or quote entered into between Lirk Nor and the Client, including all annexes.
"Services" means all advisory, consultancy, dossier-preparation, notification, training, and related services in the field of technical product regulatory compliance, provided by Lirk Nor's consultants and, where applicable, engaged specialists. This includes but is not limited to: EU chemicals regulation (REACH, CLP, BPR, PIC, F-gas, POPs, PFAS restrictions); IUCLID dossier work; Classification & Labelling Notifications and Poison Centre Notifications (Annex VIII CLP); medical devices (MDR/IVDR); cosmetics regulation (CPR/CPNP); pharmaceutical and life sciences regulatory advice; food contact materials; toy safety; RoHS/SCIP; General Product Safety Regulation; position papers; regulatory strategy; gap assessments; compliance reviews; workshops; and training. This list is illustrative and not exhaustive. Lirk Nor's scope of Services may expand to additional regulatory areas over time without amendment to these GTC being required.
"Deliverables" means any written output produced by Lirk Nor under the Services, including advisory memos, IUCLID files and dossier sections, C&L and PCN submissions, technical documentation support, position papers, gap reports, and presentations.
"Background IP" means all intellectual property rights, methodologies, frameworks, templates, tools, know-how, and generic learnings owned or developed by Lirk Nor independently of any specific engagement, including pre-existing materials embedded in Deliverables.
"PI Insurance" means the professional indemnity insurance policy maintained by Lirk Nor as described in Article .
"Applicable Regulations" means EU product regulations, national implementing legislation, and related guidance in force at the date on which the relevant advice or Deliverable is provided.
Applicability and Order of Precedence
These General Terms and Conditions (“GTC”) apply to all offers, quotes, engagements, and agreements between Lirk Nor and a Client, unless expressly deviated from in writing.
In the event of conflict between documents, the following order of precedence applies (highest first): (i) an individually signed agreement between Lirk Nor and the Client; (ii) a signed engagement letter or quote specific to the relevant assignment; (iii) these GTC.
The Client’s general purchasing conditions or any other procurement terms are expressly excluded and do not apply, even if referred to by the Client. Acceptance of an offer by Lirk Nor does not constitute acceptance of any such conditions. To the extent Article 6:225(3) BW could otherwise produce a “first shot” effect, Lirk Nor hereby expressly and timely rejects any such application.
The rejection in Article shall be reproduced in all quotes and engagement letters issued by Lirk Nor.
Formation and Scope of Engagement
An Agreement for Services is formed when the Client accepts a written offer or engagement letter issued by Lirk Nor, or when Lirk Nor begins performing Services at the Client's written request.
The scope of Services is as described in the relevant Agreement or engagement letter. Any changes to scope require written agreement between the parties.
Quoted timelines and cost estimates are indicative only and do not constitute binding commitments, unless expressly stated to be fixed in the relevant Agreement.
Nature of Services
All Services are performed on the basis of a best-efforts obligation (inspanningsverplichting). Lirk Nor undertakes to perform Services with due care and professional diligence, but does not warrant or guarantee any specific regulatory outcome, result, or third-party decision.
In particular, Lirk Nor provides no guarantee, express or implied, that:
ECHA will accept any dossier, registration, or notification;
a Notified Body will issue a certificate under MDR or IVDR;
a Cosmetic Product Notification will be accepted via CPNP;
any regulatory authority will adopt a particular position;
customs authorities will clear any product; or
any other regulatory deadline or objective will be achieved.
Any statement by Lirk Nor regarding likely timelines, probability of regulatory success, or regulatory strategy constitutes a professional opinion only, not a guarantee.
Client obligations
The Client shall provide Lirk Nor in a timely manner with all information, data, documents, and access reasonably required for the performance of the Services.
The Client warrants that all information provided to Lirk Nor is accurate, complete, and up to date. Lirk Nor is entitled to rely on such information without independent verification.
Lirk Nor accepts no liability for any advice, Deliverable, or outcome that is deficient as a result of inaccurate, incomplete, or outdated information provided by the Client.
If the Client discovers that information provided was inaccurate or incomplete, it shall notify Lirk Nor immediately in writing. Lirk Nor has no obligation to revisit prior advice without additional remuneration.
Regulatory currency
All advice and Deliverables are based on Applicable Regulations in force at the date the advice or Deliverable is provided. EU product regulation is subject to frequent and material change.
Lirk Nor is under no obligation to update, revise, or supplement prior advice or Deliverables to reflect subsequent regulatory changes, unless expressly agreed in writing for additional remuneration.
Intellectual property
Subject to full payment of all fees due, Lirk Nor assigns to the Client ownership of the specific Deliverables produced for that Client under the relevant Agreement, to the extent such Deliverables do not incorporate Background IP.
Lirk Nor retains all rights to its Background IP. Where a Deliverable incorporates Background IP, Lirk Nor grants the Client a non-exclusive, non-transferable, non-sublicensable licence to use that Background IP solely to the extent embedded in the Deliverable and solely for the Client's own internal business purposes.
Lirk Nor retains the right to use its Background IP, methodologies, templates, know-how, and generic learnings derived from any engagement on other engagements, subject to the confidentiality obligations in Article .
Where Lirk Nor uses tools, software, or databases under a third-party licence agreement or under access rights granted by a client or other third party, the intellectual property terms of that licence or agreement govern those materials and are not affected by these GTC. Such third-party terms are covered by the order of precedence in Article where they form part of an individually signed agreement.
The Client may not:
modify or create derivative works of any Deliverable incorporating Background IP without Lirk Nor's prior written consent; or
sublicence, share, or disclose any Deliverable to third parties except for the Client's own internal use.
The default IP arrangements in this Article may be overridden by an individually signed agreement, which prevails pursuant to Article .
IP Indemnity
Lirk Nor's indemnity to the Client in respect of intellectual property infringement is limited to claims arising directly from Lirk Nor's own wilful misconduct (opzet) or gross negligence (grove nalatigheid) in the creation of the relevant Deliverable.
Where such indemnity applies, it is capped at the total fees paid by the Client to Lirk Nor in the twelve (12) months immediately preceding the event giving rise to the claim.
Lirk Nor provides no indemnity for:
infringement arising from the Client's use of a Deliverable outside the scope of the licence in Article ;
third-party content supplied by the Client and incorporated into a Deliverable;
modifications of a Deliverable made by or on behalf of the Client; or
use of tools or databases under third-party licence terms as described in Article .
Confidentiality
Each party shall keep confidential all non-public information received from the other party in connection with the Services ("Confidential Information") and shall not disclose it to any third party without prior written consent of the disclosing party.
Confidential Information does not include information that:
is or becomes publicly known through no breach of this Article;
was already known to the receiving party at the time of disclosure;
is independently developed by the receiving party without use of Confidential Information; or
is required to be disclosed by law or court order, provided the receiving party gives prompt written notice where permitted.
Confidentiality obligations survive termination or expiry of any Agreement without limit in time.
In the event of breach of confidentiality obligations, the aggrieved party is entitled to damages under Dutch law. No contractual penalties (boetebeding) apply as default under these GTC. Individually signed agreements — including standalone NDAs — may impose a stricter regime by express written agreement.
Subcontracting and personnel
Lirk Nor is entitled to engage subcontractors and employ or deploy personnel (including consultants, employees, and specialist firms) in the performance of the Services. This includes public affairs partners, specialist REACH/IUCLID consultants, and specialists in other regulated industry areas such as cosmetics, pharmaceuticals, food contact materials, and medical devices.
All persons or entities engaged by Lirk Nor in the performance of the Services shall be bound by confidentiality obligations at least equivalent to those in Article .
Lirk Nor remains responsible to the Client for the performance of any subcontracted Services, regardless of which individuals or entities carry out the work.
Liability
Lirk Nor is liable to the Client only for direct damages caused by Lirk Nor's own wilful misconduct or gross negligence in the performance of the Services.
Lirk Nor is not liable for any indirect, consequential, or special damages, including:
loss of profit or revenue;
loss of goodwill or reputation;
loss of contracts or business opportunities;
regulatory fines, penalties, or administrative measures imposed on the Client;
market access losses;
product recall costs; or
reputational damage.
Lirk Nor's total aggregate liability in respect of any claim or series of related claims shall be limited to the greater of:
the maximum amount recoverable under Lirk Nor’s professional indemnity insurance in force at the time the relevant claim is made; or
the total fees paid by the Client to Lirk Nor in the twelve (12) calendar months immediately preceding the event giving rise to the claim.
These limitations do not apply to liability that cannot be excluded under mandatory Dutch law, including liability for death or personal injury caused by gross negligence or wilful misconduct.
Professional Indemnity Insurance
Details of the PI Insurance are available to the Client upon written request.
Payment terms
Fees may be structured as an hourly rate, a fixed project fee, a retainer with a monthly cap, or a combination thereof, as agreed in the relevant engagement letter or Agreement. Where no specific fee structure is agreed, Lirk Nor will invoice on a time-and-materials basis at its prevailing hourly rates. All fees are invoiced in euros (EUR) unless otherwise agreed in writing in the relevant Agreement.
Invoices are payable within thirty (30) calendar days of the invoice date, unless otherwise agreed in writing.
In the event of late payment, the Client is automatically in default upon expiry of the payment period without any further notice being required. The statutory commercial interest rate (wettelijke handelsrente) accrues on the outstanding amount from that date.
Lirk Nor reserves the right to suspend performance of the Services if payment is overdue by more than thirty (30) calendar days following written notice of suspension.
Limitation period
Any claim against Lirk Nor must be notified in writing within six (6) months of the date on which the Client became aware, or reasonably should have become aware, of the facts giving rise to the claim.
In any event, all claims lapse twelve (12) months after delivery of the relevant Deliverable or completion of the relevant Service, regardless of when the Client became aware.
Force majeure
Lirk Nor is not liable for any failure or delay in performance to the extent caused by circumstances outside its reasonable control.
Force Majeure includes without limitation:
unavailability or technical failures of ECHA systems, REACH-IT, or IUCLID;
delays or changes in regulatory deadlines imposed by the European Commission, ECHA, or national competent authorities;
delays attributable to Notified Bodies in MDR/IVDR certification processes;
epidemic, pandemic, war, civil unrest, or government action; and
telecommunications or internet failures.
Lirk Nor shall notify the Client as soon as reasonably practicable of a Force Majeure event and shall use reasonable endeavours to mitigate its effects.
Termination
Either party may terminate an ongoing engagement by giving thirty (30) calendar days' written notice.
Either party may terminate with immediate effect by written notice if:
the other party commits a material breach and, where remediable, fails to remedy it within fourteen (14) days of written notice; or
the other party becomes insolvent, is declared bankrupt, applies for a moratorium (surseance van betaling), or is subject to debt restructuring proceedings.
Lirk Nor may additionally terminate with immediate effect by written notice if the Client makes or submits a regulatory filing using Lirk Nor's advice in a manner that Lirk Nor has expressly and in writing advised against, where such use creates a material risk of reputational harm or regulatory non-compliance for Lirk Nor.
Upon termination, the Client shall pay Lirk Nor for all Services performed and expenses properly incurred up to the date of termination.
Articles , , , , and survive termination.
Complaints procedure
Any complaint regarding the Services must be submitted to Lirk Nor in writing, setting out the nature and grounds of the complaint in sufficient detail.
Lirk Nor will acknowledge receipt within five (5) working days and respond substantively within four (4) weeks of receipt.
The parties shall attempt to resolve any complaint in good faith. Only after exhaustion of this internal procedure, or if no resolution is reached within four (4) weeks, may either party initiate formal dispute proceedings under Article .
Governing law and jurisdiction
These GTC and all agreements to which they apply are governed by the laws of the Netherlands.
Any dispute arising from or in connection with these GTC or any Agreement shall be submitted exclusively to Rechtbank Midden-Nederland, location Utrecht. This clause functions as a fallback and applies unless a different forum is expressly agreed in an individually signed Agreement.
Data protection
In the course of providing the Services, Lirk Nor may process limited personal data of Client representatives, restricted to: first name, last name, company name, and business email address.
Lirk Nor acts as an independent data controller for such processing, for the purpose of managing the client relationship and performing the Services, in accordance with the GDPR and applicable Dutch data protection law.
No data processing agreement (verwerkersovereenkomst) is required under these GTC, as Lirk Nor does not process personal data as a processor on behalf of the Client. If the scope of any engagement changes such that Lirk Nor would act as a data processor, the parties shall enter into a separate data processing agreement before such processing begins.
Miscellaneous
If any provision of these GTC is found invalid or unenforceable, the remaining provisions continue in full force. The parties shall negotiate in good faith to replace any invalid provision with a valid one achieving the same intent.
Lirk Nor may amend these GTC upon thirty (30) days' written notice. Amended GTC apply to new engagements entered into after the effective date. Engagements already in progress remain governed by the GTC in force at the time of engagement unless the Client expressly agrees to the amendment.