Hardware Terms - Vermillion Health Ltd.

Alevia and Alevia PRO Hardware Terms of Use

Last Updated: 28 August 2026

1. Definitions

Vermillion Health, we, us, or our: Vermillion Health Technologies (UK) Limited (Company number 16873746)
Alevia PRO Device, Alevia Device or Device: Alevia or Alevia PRO hardware device and any accessories, components, firmware, documentation, and accompanying materials supplied with it.
Alevia App: The mobile application and associated software provided by Vermillion Health for use with the Device.
Consumer User: A User who obtains the Device for personal use and acts as a consumer under applicable consumer protection laws.
Business User: An organization, NHS trust, clinic, or other entity (and its personnel) that uses the Alevia Device or accesses the Alevia App or Cloud Services under an agreement with that organization.
User: Any individual who accesses, uses, wears, operates, receives, or is provided with a Device, whether as a Consumer User or through a Payer.
Payer: Any healthcare provider, NHS organisation, clinic, hospital, insurer, employer, research institution, public health authority, or other organisation that purchases or provides the Device on behalf of a User.
Force Majeure: Any event or circumstance beyond a party's reasonable control that prevents or delays performance of its obligations under these Terms.
Alevia Connect Cloud Services: The cloud-based platform, online services, data storage, connectivity services, and related infrastructure provided by Vermillion Health in connection with the Device and the Alevia App.
Instructions for Use: The documentation, manuals, labelling, safety information, and guidance supplied with the Device or available to the user from other sources such as the Alevia App or Vermillion Heath Website.
Terms: These Hardware Terms of Use.
Data: All information, content, records, usage information, technical data, device-generated data, personal information, health data, and other information collected, generated, transmitted, stored, processed, or accessed through the Alevia Device, the Alevia App, Alevia Connect Cloud services, or related systems.
Intellectual Property Rights: All worldwide rights in patents, copyrights, trademarks, trade secrets, know-how, and other IP.
Personal Information: Information about an identifiable, living person.
Consumer Contracts Regulations: The Consumer Contracts (Information, Cancellation and Additional Charges) Regulations 2013, as amended from time to time.
Fees: The subscription fees, charges, taxes, and other amounts payable by a
Payment Terms: The payment schedules, billing arrangements, renewal terms, payment methods, and other payment conditions communicated by Vermillion Health from time to time.
Confidential Information: Any non-public information disclosed by one party to another in connection with the Device, services, or these Terms, whether in written, oral, electronic, or other form, which is identified as confidential or would reasonably be understood to be confidential by its nature.
Start Date: The date on which the User first activates, accesses, receives, or begins using the Device, whichever occurs first.

2. Who These Terms Apply To

These Hardware Terms of Use ("Terms") govern the access, operation, and use of Alevia and Alevia PRO hardware devices ("Device").

The Device may be provided to an individual ("User") through one of the following channels:

By a healthcare provider, healthcare organisation, insurer, employer, public health authority, research institution, or other entity that acquires the Device on behalf of the User (each a "Payer"); or
By direct purchase from Vermillion Health or an authorised reseller by the User in their personal capacity as a Consumer User.

These Terms apply to all Users regardless of how the Device was obtained.

Where the Device is supplied by a Payer, the agreement governing the purchase of the Device remains between Vermillion Health and the Payer. However, the User must comply with these Terms when using the Device.

By using the Device, the User agrees to these Terms.

Use of the Alevia App and Alevia Connect Cloud services is governed by Alevia and Alevia Connect Cloud Service Terms of Use, which apply in addition to these Hardware Terms.

3. Intended Use

The Device must only be used:

For its intended purpose as described in the Instructions for Use;
In accordance with all safety warnings and operating instructions;
By the individual for whom the Device has been provided; and
In compliance with applicable laws and regulations.

The User must not use the Device in any manner inconsistent with its intended use.

4. Medical Disclaimer

The Device is intended to support the purposes described in the Instructions for Use.

The Device does not replace professional medical advice, diagnosis, treatment, monitoring, or clinical judgment.

Users should continue to follow the advice of their healthcare professionals and should seek appropriate medical attention whenever symptoms worsen, new symptoms arise, or medical assistance is otherwise required.

No information produced by the Device should be relied upon as the sole basis for making healthcare decisions.

5. User Responsibilities

Users are responsible for:

Reading and following the Instructions for Use;
Using the Device safely and responsibly;
Maintaining the Device in accordance with any maintenance instructions;
Keeping the Device secure from misuse by unauthorised persons;
Providing accurate information where required for setup or support;
Promptly reporting defects, malfunctions, or safety concerns; and
Installing software or firmware updates made available by Vermillion Health where appropriate.

Users must not:

Modify, disassemble, reverse engineer, or tamper with the Device except where permitted by law;
Use the Device for unlawful purposes;
Interfere with any safety or security features of the Device;
Use the Device outside its intended purpose; or
Permit use of the Device in a manner inconsistent with these Terms.

6. Devices Supplied Through a Payer

Where the Device is supplied by a Payer:

Ownership of the Device remains with the Payer unless a transfer of ownership to the User is formally recorded.
The User may be required to comply with additional policies of the Payer.
The User's right to use the Device may end when participation in the relevant programme, treatment pathway, employment arrangement, research study, or healthcare service ends.
The Payer is responsible for certain support, collection, maintenance, replacement, or return arrangements unless a formal support arrangement has been put in place with Vermillion Health.

Nothing in these Terms modifies or supersedes any agreement between Vermillion Health and a Payer.

Nothing in these Terms limits any legal rights that a User may have against the relevant Payer.

7. Clinical Oversight

Where the Device is provided as part of a healthcare programme, treatment pathway, or clinical service, healthcare professionals may review information generated by the Device in accordance with applicable laws, clinical procedures, and privacy requirements.

Users should continue to follow the advice of their healthcare professionals and should not rely solely on Device outputs when making healthcare decisions

If you are experiencing a medical emergency, contact your local emergency services immediately (e.g. call 999 in the UK).

For non-emergency, urgent medical advice in the UK, please call NHS 111 or visit 111.nhs.uk.

8. Delivery and Receipt of the Device

The Device may be delivered by Vermillion Health, an authorised reseller, or a Payer. Any delivery dates or times communicated to a User are estimates unless expressly stated otherwise. Vermillion Health, the authorised reseller, or the relevant payer will use reasonable efforts to deliver the Device within any estimated delivery timeframe communicated to the User.

8.1 Delivery Information

Where delivery is made directly to a User, the User is responsible for providing accurate and complete address information. Vermillion Health is not responsible for delays or failed deliveries resulting from incorrect or incomplete information provided by the User.

8.2 Risk and Ownership

For Consumer User purchases, risk of loss or damage passes upon delivery where otherwise required by applicable law.

Ownership of the Device passes only after full payment of the purchase price.

Where the Device is supplied by a payer, ownership remains with the Payer unless a transfer of ownership to the User is formally recorded. Where such a formal transfer is not made, the User receives only the right to use the Device in accordance with these Terms and any applicable programme requirements.

8.3 Inspection Upon Receipt

Users should inspect the Device promptly upon delivery and report any missing items, visible damage, defects, or delivery discrepancies as soon as reasonably practicable to:

Vermillion Health or the authorised reseller, in the case of a Consumer User purchase; or
The healthcare provider, NHS organisation, or other payer that supplied the Device.

8.4 Delivery Delays

Vermillion Health shall not be responsible for delays caused by circumstances beyond its reasonable control, including: supply chain disruptions, transportation delays, customs processing, severe weather, public health emergencies, or other unforeseen events.

8.5 Force Majeure

Vermillion Health shall not be liable for any delay, failure, or interruption in the performance of its obligations under these Terms to the extent caused by circumstances beyond its reasonable control, including but not limited to acts of God, natural disasters, severe weather, fire, flood, epidemic, pandemic, war, terrorism, civil unrest, labour disputes, utility failures, telecommunications failures, cyber incidents, transportation disruptions, supply chain shortages, governmental actions, regulatory restrictions, or other events beyond its reasonable control. Vermillion Health will use reasonable efforts to mitigate the effects of any such event and to resume normal performance as soon as reasonably practicable.

Where a Force Majeure event continues for an extended period, Vermillion Health may suspend affected obligations for the duration of the event or take such other reasonable steps as may be necessary to comply with applicable legal, regulatory, or safety requirements.

8.6 Failed Deliveries

If delivery cannot be completed because the User is unavailable, refuses delivery without valid reason, or provides incorrect delivery information, additional delivery charges or administrative fees may apply where permitted by law.

8.7 Devices Supplied by a Payer

Where the Device is supplied through a healthcare programme or other payer arrangement, delivery, collection, replacement, and return procedures will be determined by the payer. The User may be required to follow additional instructions communicated by the payer regarding receipt, use, return, or replacement of the Device.

8.8 Geographic Restrictions

The Device may only be delivered to locations where Vermillion Health or its authorised distributors are permitted to supply the Device in accordance with applicable laws and regulatory requirements.

Vermillion Health reserves the right to refuse or cancel orders where delivery would violate applicable laws, regulations, or product licensing requirements.

9. Warranty

9.1 Warranty Coverage

Vermillion Health warrants that the Device will, under normal and intended use, materially conform to its published specifications and be free from defects in materials and workmanship for a warranty period of one (1) year from the date of supply.

This warranty applies in addition to any rights that a User may have under applicable law.

9.2 Warranty Claims for Payer-Supplied Devices

Where the Device is supplied by a Payer, warranty claims must be submitted through the organisation that provided the Device.

Vermillion Health may repair, replace, or service the Device in accordance with its agreement with the payer.

9.3 Warranty Claims for Consumer User Purchases

Where the Device is purchased directly by a Consumer User, warranty claims must be submitted to Vermillion Health or the authorised seller from whom the Device was purchased.

If a valid warranty claim is accepted, Vermillion Health may, at its discretion:

Repair the Device;
Replace the Device;
Provide a replacement component; or
Provide a refund where appropriate and permitted by law.

9.4 Warranty Exclusions

The warranty does not cover:

Misuse, abuse, neglect, or accidental damage;
Failure to follow the Instructions for Use;
Unauthorised modification or repair;
Normal wear and tear;
Cosmetic damage that does not affect functionality; or
Use of incompatible accessories where such use caused the defect.

Nothing in this section limits any rights that cannot legally be excluded.

10. Returns and Refunds

10.1 Devices Supplied by a Payer

Devices supplied through a Payer are not eligible for return under this policy.

Any return, replacement, collection, exchange, or disposal of such Devices shall be governed by the relevant Payer's policies.

10.2 Consumer User Right to Return

If a Consumer User purchases a Device directly from Vermillion Health's online store, the Device may be returned within fourteen (14) calendar days of receipt, provided that:

The Device remains unopened and unused;
Original packaging remains unopened and fully intact;
All security and tamper-evident seals remain unbroken;
The Device has not been activated or put into service;
All included accessories, documentation, and components are returned; and
The Device is returned in a condition suitable for resale.

10.3 Exclusions

For health, hygiene, and safety reasons, Vermillion Health will refuse a return or refund where:

The Device packaging has been opened;
The Device has been used, worn, activated, paired, or otherwise put into service;
Any tamper-evident seal has been broken or removed;
Components, accessories, or documentation are missing; or
The Device has been damaged after delivery.

This does not affect any statutory rights relating to defective, damaged, or non-conforming products.

10.4 Return Process

The Consumer User must notify Vermillion Health of their intention to return the Device before the expiry of the 14-day return period and must follow Vermillion Health's return instructions.

10.5 Refunds

Eligible refunds will be processed within a reasonable period following receipt and inspection of the returned Device and will generally be made using the original payment method.

The Consumer User will be responsible for return shipping costs unless otherwise required by applicable law.

11. Lost, Stolen or Damaged Devices

Users of devices supplied by a Payer should notify the supplying Payer as soon as reasonably practicable if a Device is lost, stolen, or damaged. Replacement of lost or damaged Devices will be subject to the policies of the relevant Payer or healthcare provider.

12. Software and Firmware Updates

Vermillion Health may provide software and firmware updates to:

Improve functionality;
Maintain cybersecurity;
Correct defects;
Meet regulatory requirements;
Improve interoperability; and
Enhance safety and performance.

Users should install available updates within a reasonable period unless instructed otherwise by a healthcare professional.

Vermillion Health may require certain updates to maintain safety, security, legal compliance, or Device functionality.

13. Product Safety and Recall

If Vermillion Health identifies a safety issue affecting the Device, Vermillion Health may:

Issue safety notifications;
Provide software or firmware updates;
Initiate corrective actions;
Repair or replace affected Devices;
Conduct a Field Safety Corrective Action (FSCA); or
Conduct a product recall where required.

Users should comply with all safety communications and instructions provided by Vermillion Health, a healthcare provider, regulator, or Payer.

14. Adverse Event Reporting

Users should promptly report any serious incident, injury, malfunction, or adverse event associated with the Device to:

Vermillion Health; and
Their healthcare provider where appropriate.

Reporting safety-related incidents assists Vermillion Health in maintaining the safety and effectiveness of the Device.

15. Privacy and Data Protection

Where the Device collects, stores, generates, or transmits personal data or health information, such information will be handled in accordance with:

Vermillion Health's Privacy Policy; and
Applicable data protection and privacy laws.

We may need access to your Data to perform our obligations. Authorized personnel may access it for this purpose. Nothing in these Terms overrides any rights available under applicable data protection legislation.

Controller/Processor roles: For Consumer Users, Vermillion Health acts as the Data Controller of your personal data. For Business Users, Vermillion Health acts as the Data Processor on behalf of the Business User (who is the Data Controller), under any applicable data processing agreement between the parties.

For details of how we collect, use, and protect personal data, and your data subject rights, see our Privacy Policy, which forms part of these Terms.

16. Intellectual Property

All intellectual property rights in the Device, associated software, firmware, trademarks, documentation, logos, branding and associated materials remain the property of Vermillion Health or its licensors. No ownership of intellectual property rights is transferred to the User under these Terms.

17. Limitation of Liability

Statutory Rights: Nothing in these Terms excludes or limits any right you have as a Consumer User under the Consumer Rights Act 2015 or other applicable UK consumer protection legislation, and nothing in these Terms affects your statutory rights.

Nothing in these Terms excludes or limits our liability for death or personal injury caused by our negligence, defective products where liability cannot legally be excluded; or for fraud or fraudulent misrepresentation, where you are a Consumer User (or otherwise where such exclusion is not permitted by law).

Subject to the foregoing, and to the maximum extent permitted by law, Vermillion Health shall not be liable for indirect, incidental, special, consequential, exemplary, or punitive losses arising from use of the Device.

18. End of Support

Subject to applicable legal and regulatory obligations, Vermillion Health may discontinue manufacture, distribution, support, or updates for a Device upon reasonable notice.

Where reasonably practicable, Vermillion Health will communicate material end-of-support information to affected Users or Payers.

19. Confidentiality

Each party must keep the other’s Confidential Information secure and not disclose it without consent.

Exceptions include disclosures: (a) to perform obligations; (b) required by law; (c) of publicly available information; (d) received from a third party without restriction; or (e) in connection with corporate transactions.

20. Term, Termination and Suspension

Unless terminated earlier, these Terms start on the Start Date These and continue for so long as the User possesses, accesses, or uses the Device unless terminated in accordance with these Terms.

No refunds or compensation are provided upon termination, except that this clause does not affect any statutory right a Consumer User has to a refund, repair, or replacement under the Consumer Rights Act 2015 or the Consumer Contracts (Information, Cancellation and Additional Charges) Regulations 2013.

21. Governing Law and Dispute Resolution

These Terms, and any dispute or claim arising out of or in connection with them, are governed by and construed in accordance with the laws of England and Wales.

For Payers: Each party irrevocably agrees that the courts of England and Wales shall have exclusive jurisdiction to settle any dispute or claim arising out of or in connection with these Terms.

For Consumer Users: If you are a Consumer User habitually resident in Scotland or Northern Ireland, you may also bring proceedings in your local courts, and nothing in this clause affects any mandatory consumer protections available to you under the law of your country of residence.

22. Fair Interpretation

If any provision of these Terms is found to be unlawful, invalid, or unenforceable, that provision shall be interpreted or modified only to the extent necessary, and the remaining provisions shall remain in full force and effect.

23. Changes to These Terms

We may change these Terms at any time by updating them on the Vermillion Health Website. Notice may be provided by posting the updated Terms or by email. Unless stated otherwise, changes take effect immediately. Continued use constitutes acceptance.
For Consumer Users, we will provide at least twenty-eight (28) days’ notice of any material change to these Terms before the change takes effect, by posting notice on the Website or by email.
These Terms where last updated on 28 August 2026.

24. Contact Us

Questions regarding these Terms, product support, warranty claims, returns, product safety concerns, or adverse event reporting may be directed to:

Vermillion Health Technologies (UK) Ltd

Dukes House, 4-6 High Street, Windsor, Berkshire, England, SL4 1LD
support@vermillionhealth.com
vermillionhealth.com

For questions or complaints, contact: support@vermillionhealth.com