Version: 1.2

Last updated: 24 October 2026

These General Terms of Service apply to every quotation issued by Medecly Limited. Previous versions are available on request.

1. Interpretation and Definitions

1.1 Unless the context otherwise requires, references to the singular include the plural and references to the masculine include the feminine, and vice versa.

1.2 The headings contained in these Terms are for convenience only and do not affect their interpretation.

1.3 A reference to a particular law is a reference to it as it is in force for the time being taking account of any amendment, extension, or re-enactment and includes any subordinate legislation for the time being in force made under it.

1.4 The following definitions apply in these Terms:

“Agreement”: the contract between the Consultancy and the Client formed by the Client's acceptance of a quotation, incorporating these Terms.

“Business Day”: a day other than a Saturday, Sunday or public holiday in England.

“Change Order”: a written amendment to an active quotation or project scope, executed by authorised representatives of both parties, specifying changes to the scope, deliverables, timetables, or fees.

“Client”: the person, firm, or legal entity identified in the applicable quotation.

“Consultancy”: Medecly Limited (registered in England under Company No. 17342870).

“Consultancy Services”: the regulatory affairs, quality assurance, technical, and advisory consultancy services specified in an applicable quotation.

“Data Protection Legislation”: all applicable data protection and privacy legislation in force from time to time in the UK including the retained EU law version of the General Data Protection Regulation ((EU) 2016/679) (UK GDPR), the Data Protection Act 2018 (and regulations made thereunder) or any successor legislation, and all other legislation and regulatory requirements in force from time to time which apply to a party relating to the use of personal data.

“Effective Date”: the date on which the Client accepts the quotation in accordance with Clause 2.1.

“Deliverables” or “Works”: all records, reports, documents, papers, drawings, gap analyses, software programs, filings, and materials prepared by the Consultancy in connection with the provision of the Consultancy Services under a quotation.

“Inside IR35”: where an engagement or contract between the Consultancy and the Client is considered to fall within the provisions of Chapter 8 or Chapter 10 of the Income Tax (Earnings and Pensions) Act 2003 (ITEPA), making gross amounts payable subject to PAYE Income Tax and National Insurance Contributions.

“Intellectual Property Rights”: patents, utility models, rights to Inventions, copyright and neighbouring and related rights, moral rights, trade marks and service marks, business names and domain names, rights in get-up, goodwill, rights in designs, computer software, database rights, rights to use and protect confidential information (including know-how and trade secrets), and all other intellectual property rights, whether registered or unregistered, and including all applications and rights to apply for and be granted renewals or extensions in any part of the world.

“Invention”: any invention, idea, discovery, development, improvement or innovation made by the Consultancy in connection with the provision of the Consultancy Services, whether or not patentable or capable of registration.

“Pre-Existing IP”: all Intellectual Property Rights owned by or licensed to the Consultancy prior to the commencement of the Agreement or developed independently outside the scope of any quotation, including the Consultancy's standard methodologies, tools, frameworks, templates, generic software, and know-how.

“quotation” or “Order Form”: the quotation or order form issued by the Consultancy to the Client detailing the specific Consultancy Services, deliverables, fees, payment schedule, and commercial terms.

“Terms” or “Terms of Business”: these General Terms of Service (Version 1.2).

“Worker(s)”: the individual(s), personnel, or subcontractors assigned by the Consultancy to perform the Consultancy Services.

2. Formation of Contract

2.1 Each quotation is an offer to perform the Consultancy Services on these Terms, open for acceptance during its validity period. The Client accepts it by signing it, confirming acceptance in writing, or issuing a Purchase Order that references it. The Agreement is formed on the Effective Date. The Consultancy will countersign and return a copy, but countersignature is not a condition of the Agreement.

2.2 These Terms govern all quotations issued by Medecly Limited to the exclusion of any other terms that the Client seeks to impose or incorporate (including any terms contained on a Client Purchase Order or procurement portal).

3. Order of Precedence

3.1 If there is any conflict between these Terms and a quotation, these Terms prevail, except that the "Work Packages & Fees" and "Commercial Terms" sections of the quotation prevail in respect of scope, deliverables, effort estimates, fees, invoicing, payment periods, expenses and timing.

3.2 Nothing in a quotation varies Clauses 14 (Intellectual Property), 15 (Confidentiality), 17 (Liability) or 19 (Regulatory Disclaimer) unless the quotation expressly states the variation and both parties sign it.

4. Substitution

4.1 The Consultancy's obligation to provide the Consultancy Services shall be performed by one or more Worker(s) of the Consultancy as the Consultancy considers appropriate, subject to the Client being reasonably satisfied that the Worker(s) has the required skills, qualifications, and resources.

4.2 The Consultancy has the right, at its own expense, to enlist additional or substitute Workers, or to sub-contract all or part of the Consultancy Services, provided that the Consultancy provides details whenever requested and the Client is reasonably satisfied as to the substitute's skills and qualifications.

4.3 Where the Consultancy provides a substitute or sub-contracts pursuant to Clause 4.2, the Consultancy shall remain responsible for paying the substitute or subcontractor and shall remain responsible for their acts or omissions.

4.4 The Consultancy shall take all reasonable steps to avoid unplanned changes of Worker. If the Consultancy is unable to perform the Consultancy Services, it shall inform the Client as soon as reasonably practicable and provide a substitute pursuant to Clause 4.2.

4.5 If the Consultancy is unable to supply either the original personnel or suitably skilled substitutes for a period of fourteen (14) consecutive days or more, the Client is entitled to terminate the affected quotation forthwith upon written notice.

4.6 The Client acknowledges and accepts that the Consultancy is in business on its own account and shall be entitled to seek, apply for, accept, and perform contracts to supply its services to any third party during the term of the Agreement.

5. Scope of Services

5.1 The Consultancy shall provide the Consultancy Services and Deliverables set out in the applicable quotation.

5.2 The Consultancy shall not be required to provide any services in addition to those specified in the applicable quotation. Any requests for additional services shall be subject to the prior written approval of the Consultancy (at its sole discretion) and documented in a written Change Order or a new quotation executed by both parties before the additional services begin. Work requested under an on-request work package, or additional effort approved under the quotation's Commercial Terms, is not an additional service for the purposes of this Clause.

5.3 No variation or alteration of these Terms shall be valid unless agreed between the Client and the Consultancy in writing, except where changes to the Consultancy Services are necessary to comply with applicable safety, statutory, or regulatory requirements.

6. Warranties

6.1 The Consultancy warrants to the Client that entering into and performing its obligations under the Agreement will not breach any obligation owed to any third party.

6.2 The Consultancy warrants that its Workers possess the necessary skills and qualifications to perform the Consultancy Services set out in the quotation. The costs for any training required to maintain such qualifications shall be borne by the Consultancy.

6.3 Where the Consultancy is liable under Chapter 8 of ITEPA, it shall at all times comply with ITEPA and the Social Security Contributions and Benefits Act 1992 (SSCBA) regarding income tax and National Insurance Contributions.

7. Consultancy Obligations

7.1 The Consultancy agrees to:

7.1.1 comply with any essential statutory rules, health and safety policies, and security procedures notified by the Client when working on the Client's premises (provided that Workers shall not be bound by general employee policies);

7.1.2 furnish the Client with reasonable progress reports as requested from time to time; and

7.1.3 perform the Consultancy Services specified in the applicable quotation with all due care, skill, ability, and diligence.

8. Equipment

8.1 The Consultancy shall provide at its own cost, subject to any agreement to the contrary in the quotation, all necessary equipment reasonable for the satisfactory performance of the Consultancy Services.

8.2 If, as a matter of convenience, the Consultancy is provided with Client equipment, the Consultancy shall preserve the security and condition of such equipment and be responsible for repair or replacement costs if lost while in its possession (excluding fair wear and tear or damage caused by the Client).

9. Method of Performance

9.1 The Client shall have no right to, nor shall seek to, exercise any direction, control, or supervision over the Consultancy in the provision of the services. The Consultancy retains absolute autonomy over its working methods.

9.2 The Consultancy may perform the Consultancy Services at such times, days, and locations as it decides, subject to ensuring proper completion of the services and obtaining necessary access to Client facilities.

9.3 The relationship between the parties is between independent corporate bodies acting at arm’s length. Nothing in the Agreement shall establish any partnership, joint venture, agency, or employer-employee relationship between the parties or their personnel.

9.4 Where performance is dependent on tasks performed by third parties (including Client employees), the Consultancy shall have no liability for delays or non-performance arising from such third-party delay or non-performance.

10. Invoicing

10.1 "Completion" occurs upon delivery of the relevant Deliverable or milestone specified in the quotation. Unless specified otherwise in the quotation, if the Client does not notify the Consultancy in writing of any material non-conformance within ten (10) Business Days of delivery, or puts the Deliverable into operational use, the Deliverable shall be deemed accepted and completed ("Completion").

10.2 The Consultancy shall invoice as set out in the quotation (or, where the quotation is silent, upon Completion), giving a detailed breakdown showing the work performed, company registration number, and VAT details.

10.3 The Client shall not be obliged to pay fees unless a valid invoice has been submitted in accordance with Clause 10.2.

11. Fees, Expenses and Payment

11.1 The Client shall pay the Consultancy the fees set out in the quotation. All fees are exclusive of VAT or other applicable sales taxes, which shall be added to invoices at the prevailing rate.

11.2 Invoices shall be paid by the Client in full, without deduction, withholding, or set-off, within fourteen (14) calendar days of the invoice date.

11.3 All payments shall be made by a bank transfer method giving immediately available funds.

11.4 If any undisputed invoice remains unpaid 14 days after its due date, the Consultancy may, on giving 7 days' written notice, suspend the Consultancy Services until payment is received. The Consultancy may also charge interest under the Late Payment of Commercial Debts (Interest) Act 1998. Any agreed timescales are extended by the period of suspension.

11.5 If the Consultancy is unable for any reason to provide the Consultancy Services, no fee shall be payable for the period services are not provided.

11.6 The Consultancy shall bear its own standard operating expenses. The Client shall only reimburse out-of-pocket expenses (such as travel) where provided for in the quotation, or otherwise approved by the Client in writing in advance (email is sufficient), and supported by valid receipts.

11.7 If Workers are required to travel abroad for the Consultancy Services, the Consultancy shall handle necessary travel insurances, inoculations, and immigration requirements.

11.8 Subject to Clause 11.9, the Consultancy shall be responsible for all PAYE Income Tax and National Insurance Contributions payable in respect of its Workers.

11.9 If Chapter 10, Part 2 of ITEPA applies and a Status Determination Statement (SDS) issued by the Client deems the engagement "Inside IR35", the Client (or fee-payer) shall be responsible for deducting relevant PAYE income tax and NICs in accordance with applicable tax legislation.

12. Obligations of the Client

12.1 The Client shall pay all invoices in accordance with Clause 11.2.

12.2 The Client shall promptly furnish the Consultancy with all necessary information, technical files, device data, and access required to perform the Consultancy Services.

12.3 The Client shall advise the Consultancy of any relevant health and safety information affecting Workers.

13. Term and Termination

13.1 The Agreement starts on the Effective Date and continues until the Consultancy Services are completed, unless terminated earlier under this Clause 13. Work starts on the start date stated in the quotation or otherwise agreed in writing.

13.2 Either party may terminate an active quotation or the Agreement by giving not less than thirty (30) days' written notice to the other. Upon termination, the Client shall within 30 days pay the Consultancy for all services performed, deliverables submitted, and non-cancellable pre-approved expenses incurred up to the effective date of termination.

13.3 Either party may terminate the Agreement or an active quotation immediately by written notice if the other party:

13.3.1 commits a material breach and (if remediable) fails to remedy it within 14 days of receiving written notice specifying the breach;

13.3.2 breaches material statutory health and safety or regulatory obligations;

13.3.3 is prevented from performing services for 14 consecutive days due to illness/incapacity where no substitute is provided under Clause 4.2; or

13.3.4 enters insolvency, administration, liquidation, or a winding-up petition.

13.4 Upon Completion or termination of a quotation, the Client is under no obligation to offer further work, nor is the Consultancy obliged to accept further work.

14. Intellectual Property

14.1 Subject to Clause 14.2 and upon receipt of full payment of all fees due under the quotation, the Consultancy assigns to the Client all Intellectual Property Rights in the bespoke Deliverables created specifically for the Client under that quotation.

14.2 The Consultancy retains absolute ownership of all Pre-Existing IP, methodologies, frameworks, and tools. To the extent Pre-Existing IP is incorporated into Deliverables, the Consultancy grants the Client a non-exclusive, perpetual, royalty-free, non-transferable license to use such Pre-Existing IP solely as necessary to utilise the Deliverables.

14.3 The Consultancy warrants that it has the power to assign/license IP as set out herein and that, to the best of its knowledge, Deliverables created under a quotation will not infringe third-party IP rights.

14.4 The Consultancy shall indemnify the Client against direct, reasonable costs awarded by a court arising directly from a third-party claim that Deliverables infringe that third party’s IP rights, provided the Client gives prompt notice, grants sole defense authority, makes no admissions, and subject always to the liability cap in Clause 17.1.

15. Confidentiality

15.1 Each party ("Receiving Party") agrees to keep secret and confidential all technical, commercial, financial, or operational information, trade secrets, and know-how of the other party ("Disclosing Party") obtained in connection with the Agreement ("Confidential Information").

15.2 Confidential Information shall not include information that: (a) becomes publicly available without breach; (b) was lawfully in possession prior to disclosure; (c) is lawfully disclosed by a third party; (d) is independently developed; or (e) is required to be disclosed by law or regulatory court order.

15.3 Confidentiality obligations shall continue during the Agreement and for three (3) years following termination (trade secrets remain confidential indefinitely).

16. Notices

16.1 Formal notices under the Agreement shall be in writing and served by hand, pre-paid first-class post, or email to the primary contact address specified in the quotation.

16.2 Deemed receipt: hand delivery (at time of delivery); post (9:00 am on 2nd Business Day); email (at time of transmission provided no failure notice is received). Notices received outside 9:00 am–5:00 pm Business Days are deemed received at 9:00 am on the next Business Day.

17. Liability

17.1 Subject to Clauses 17.2 and 17.3, each party’s total aggregate liability to the other arising out of or in connection with the Agreement or any quotation (whether in contract, tort including negligence, or otherwise) shall be limited to direct losses only and shall not exceed the total fees paid or payable by the Client to the Consultancy under the specific quotation giving rise to the claim in the twelve (12) months preceding the claim, or £1,000,000, whichever is lower.

17.2 Neither party shall be liable for any indirect, special, or consequential loss, or for loss of profit, loss of business, loss of revenue, loss of goodwill, or loss of anticipated savings.

17.3 Nothing in the Agreement limits or excludes either party’s liability for (a) death or personal injury caused by its negligence; (b) fraud or fraudulent misrepresentation; or (c) any other liability that cannot be limited or excluded by law. The limits in Clauses 17.1 and 17.2 do not apply to the Client’s obligation to pay fees and expenses properly due under the Agreement.

17.4 The Consultancy shall maintain Professional Indemnity insurance (minimum £1,000,000 per claim) and Public Liability insurance (minimum £1,000,000 per claim).

17.5 The Consultancy shall, at its own cost, rectify verified material defects in Deliverables resulting directly from its failure to perform, provided written notice is given within the acceptance period in Clause 10.1 (ten (10) Business Days of delivery).

17.6 Assigned Workers are not agency workers under the Agency Worker Regulations 2010 (AWR).

18. Data Protection & Anti-Corruption

18.1 Both parties shall comply with applicable UK Data Protection Legislation. Provision of services is not intended to involve processing Personal Data on behalf of the Client as a Data Processor. If processing personal data is explicitly required under a quotation, a separate Data Processing Addendum (DPA) shall be executed.

18.2 Both parties shall comply with all applicable anti-bribery, anti-corruption, and tax evasion facilitation laws (including Bribery Act 2010 and Criminal Finances Act 2017).

19. Regulatory Disclaimer

19.1 The Client acknowledges and agrees that it remains at all times the legal manufacturer and entity responsible for its medical devices, software, products, and regulatory filings. While the Consultancy performs services with reasonable skill and care, the Consultancy does not guarantee or warrant that any regulatory authority (including US FDA, EU Notified Bodies, or UK MHRA) will grant approval, clearance, or certification.

19.2 The Client is solely responsible for the accuracy, completeness, and truthfulness of all technical, clinical evaluation, testing, and device data supplied to the Consultancy. The Consultancy shall have no liability for errors or regulatory rejections arising from inaccurate or incomplete client-provided data.

20. General Provisions

20.1 If any provision is held illegal or unenforceable, it shall be severed, and the remaining terms shall continue in full force.

20.2 The Agreement (consisting of the signed quotation and these Terms) constitutes the entire agreement between the parties. Nothing herein invalidates or extinguishes any prior Non-Disclosure Agreement executed by the parties regarding pre-contract disclosures.

20.3 A person who is not a party to the Agreement has no rights under the Contracts (Rights of Third Parties) Act 1999.

20.4 Neither party shall be in breach for performance delays resulting from events beyond reasonable control (including Acts of God, pandemics, power failure, or cyber-attacks). Continuous delay exceeding 30 days entitles either party to terminate upon written notice.

20.5 The Agreement and any non-contractual claims arising out of it shall be governed by and construed in accordance with the laws of England and Wales. The courts of England and Wales shall have exclusive jurisdiction.