1. Definitions and Interpretation
1.1 In these Conditions, the following terms shall have the following meanings:
- “Client” means the person or entity engaging the Seller to prepare regulatory documentation.
- “Seller” means Advena Limited (Company No. C76865), Tower Business Centre, 2nd Floor, Tower Street, BKR 4013, Malta, or such other address as notified from time to time.
- “Quotation” means the written offer issued by the Seller describing the Services and applicable fees.
- “Conditions” means these standard terms and conditions.
- “Contract” means the agreement between the Seller and the Client comprising (in order of precedence): (i) the Quotation; (ii) these Conditions; and (iii) any document expressly incorporated by reference.
- “Services” means the preparation of regulatory documentation, dossiers, and associated advisory support as described in the Contract.
- “Charges” means the fees payable for the Services, as set out in the Contract.
1.2 References to statutes or regulations shall include any amendments or re-enactments.
1.3 Headings are for convenience only and shall not affect interpretation.
2. Basis of Contract
2.1 Any Quotation issued by the Seller constitutes an invitation to treat and not a binding offer.
2.2 The Client’s acceptance of a Quotation constitutes an offer to purchase Services subject to these Conditions.
2.3 No Contract shall be binding unless and until it has been agreed in writing by both parties.
2.4 The Seller shall not be obliged to commence Services prior to execution of the Contract. Any Services provided prior to execution shall be subject to these Conditions.
2.5 These Conditions apply to the exclusion of any other terms, including any terms submitted by the Client.
3. Scope of Services
3.1 The Services consist solely of the preparation of regulatory documentation and related support services as expressly described in the Quotation or Contract.
3.2 The Seller does not perform regulatory approval, testing, or certification of the Client’s products.
3.3 The Client remains solely responsible for all regulatory compliance, submission, and approval decisions.
3.4 The Seller shall rely on all information, technical data, and documentation provided by the Client and shall not be responsible for errors, omissions, or compliance failures arising from inaccurate or incomplete information.
4. Price and Charges
4.1 The Charges shall be as set out in the Quotation and may be:
- (a) a fixed fee; and/or
- (b) calculated on a time and materials basis at the Seller’s standard rate of €175 per hour (or such other rate as specified in the Contract), calculated in increments of 15 minutes.
4.2 Unless otherwise stated, all Charges are exclusive of:
- value added tax (VAT); and
- reasonable expenses including travel, accommodation, and subsistence.
4.3 The Seller reserves the right to charge for additional work outside the agreed scope, subject to prior written approval from the Client (including approval by email).
4.4 Quotations are valid for 60 days unless otherwise stated.
5. Payment Terms
5.1 The Seller shall invoice the Client in accordance with the Contract.
5.2 A deposit of 50% of the total estimated Charges shall be payable prior to commencement of the Services.
5.3 Invoices are payable within 14 days from the date of invoice.
5.4 The Seller reserves the right to:
- (a) suspend Services in the event of late payment; and/or
- (b) charge interest on overdue sums at a rate of 4% per annum above the base rate of the European Central Bank.
5.5 Deposits are non-refundable once the Seller has commenced work. If the Client cancels prior to commencement, the Seller may retain an amount reflecting reasonable administrative costs incurred.
6. Client Obligations
6.1 The Client shall:
- (a) provide complete, accurate, and up-to-date information and documentation required for the Services;
- (b) respond promptly to requests from the Seller;
- (c) review and approve all draft documentation prepared by the Seller before submission to regulatory authorities.
6.2 The Client shall remain fully responsible for all regulatory decisions, submissions, and compliance obligations.
6.3 The Seller shall not be liable for delays or additional costs arising from the Client’s failure to comply with these obligations.
7. Additional Work
7.1 Any work outside the agreed scope shall be treated as additional work.
7.2 The Seller shall not be obliged to undertake additional work unless agreed in writing (including by email).
7.3 Additional work shall be charged in accordance with Clause 4.
8. Liability
8.1 The Seller shall perform the Services with reasonable skill and care.
8.2 Nothing in these Conditions shall exclude or limit liability for:
- (a) death or personal injury caused by negligence;
- (b) fraud or fraudulent misrepresentation; or
- (c) any liability which cannot lawfully be excluded.
8.3 Subject to Clause 8.2:
- (a) the Seller shall not be liable for any indirect or consequential loss, including loss of profit, loss of business, or loss of opportunity;
- (b) the Seller’s total liability arising under or in connection with the Contract shall not exceed the total Charges paid by the Client.
8.4 The Seller does not guarantee that any regulatory submission, document, or strategy will be accepted by any authority or Notified Body.
8.5 Any claim must be brought within 12 months of completion of the Services.
9. Confidentiality
9.1 Each party shall keep confidential all confidential information received from the other party.
9.2 This obligation shall not apply to information which:
- (a) is publicly available;
- (b) was lawfully in the receiving party’s possession; or
- (c) is required to be disclosed by law or regulatory authority.
10. Intellectual Property
10.1 All intellectual property rights in materials produced by the Seller shall remain the property of the Seller unless otherwise agreed in writing.
10.2 Upon full payment, the Client is granted a non-exclusive, non-transferable licence to use such materials for its internal business purposes.
11. Authorised Representative Services
11.1 Where the Seller is appointed as an Authorised Representative, such services shall be governed strictly by a separate written mandate agreement.
11.2 The Seller’s obligations as Authorised Representative shall be limited to those expressly set out in such mandate and applicable law.
11.3 The Client shall indemnify the Seller against all claims, liabilities, damages, costs, and expenses arising from:
- (a) defective products;
- (b) non-compliance with regulatory requirements;
- (c) inaccurate or incomplete documentation provided by the Client.
11.4 The Seller shall have no liability for the Client’s failure to comply with regulatory obligations.
12. Technical Documentation and Information
12.1 The Client shall ensure that all documentation, technical files, and information provided to the Seller are complete, accurate, and up to date.
12.2 The Seller shall be entitled to rely on such information without independent verification.
12.3 The Seller shall not be liable for any consequences arising from inaccurate, incomplete, or misleading information provided by the Client.
13. Regulatory Advice Disclaimer
13.1 Any advice, guidance, or opinion provided by the Seller is based on information available at the time and reflects professional judgement.
13.2 Regulatory interpretations may change over time and may differ between competent authorities or notified bodies.
13.3 The Client remains solely responsible for all regulatory decisions and outcomes.
14. Interaction with Competent Authorities
14.1 Unless expressly agreed in writing, the Seller shall have no obligation to communicate directly with regulatory authorities, notified bodies, or other agencies on behalf of the Client.
14.2 Where such support is provided, the Seller acts solely as an advisor and not as the decision-making party.
15. Indemnity
15.1 The Client shall indemnify and keep indemnified the Seller against all claims, losses, damages, liabilities, costs, and expenses (including legal fees) arising out of or in connection with:
- (a) the manufacture, marketing, or use of the Client’s products;
- (b) any breach of applicable regulatory requirements by the Client;
- (c) any defect in the Client’s products;
- (d) reliance on inaccurate or incomplete information provided by the Client;
- (e) actual or alleged infringement of any third-party intellectual property rights, including patents, trademarks, copyrights, or trade secrets.
15.2 This indemnity shall survive termination of the Contract.
16. Insurance
16.1 The Client shall maintain appropriate product liability, regulatory compliance, and intellectual property insurance.
16.2 Upon reasonable request, the Client shall provide evidence of such insurance.
16.3 The Seller shall not be required to maintain insurance beyond its standard professional indemnity coverage.
17. Termination
17.1 Either party may terminate the Contract by written notice if the other party:
- (a) commits a material breach and fails to remedy it within 14 days; or
- (b) becomes insolvent.
17.2 The Seller may terminate immediately if the Client fails to pay any undisputed invoice when due.
17.3 Upon termination:
- (a) all outstanding invoices shall become immediately due;
- (b) the Seller shall be entitled to payment for all work performed up to termination.
18. Force Majeure
18.1 The Seller shall not be liable for failure or delay caused by events beyond its reasonable control.
19. Intellectual Property, Patents, and Third-Party Rights
19.1 The Client represents and warrants that the products, materials, and information provided to the Seller for the preparation of regulatory documentation do not infringe, misappropriate, or violate any third-party intellectual property rights, including patents, trademarks, copyrights, or trade secrets.
19.2 The Seller shall not be liable for any claims, losses, damages, or expenses arising from actual or alleged infringement of third-party intellectual property, including patents, by the Client’s products.
19.3 The Client shall indemnify and hold harmless the Seller against any such claims, losses, damages, costs, or expenses (including legal fees) arising directly or indirectly from the use of the Client’s products, materials, or information in connection with the Services.
19.4 Nothing in this Contract shall be construed as granting the Seller any license, right, or authorisation under any of the Client’s intellectual property or patents.
20. Entire Agreement
20.1 The Contract constitutes the entire agreement between the parties and supersedes all prior discussions or agreements.
21. Governing Law and Jurisdiction
21.1 The Contract and these Conditions shall be governed by the laws of England and Wales.
21.2 The parties submit to the exclusive jurisdiction of the courts of England and Wales.
