Terms and Conditions of Use

1. Definitions

In these Terms and Conditions, the following definitions apply:

"Ornia"

Ornia Limited (formerly Rova HealthTech Limited), a company incorporated under the laws of the Federal Republic of Nigeria, with UK commercial presence, operating at info@rovatechltd.co.uk and rovatechltd.co.uk.

"Ornia System"

The Ornia autonomous infant monitoring ecosystem, including the Sensor Coin hardware device, Guardian Hub base station, associated firmware, the Ornia mobile application and web platform, cloud infrastructure, and all software, algorithms, and content forming part of the system.

"User"

Any individual who accesses, registers, activates, or uses any Ornia product, service, or platform, including caregivers, parents, healthcare professionals, researchers, and institutional administrators.

"Caregiver"

A parent, legal guardian, or authorised carer responsible for an infant being monitored using the Ornia system.

"Infant"

Any monitored child for whom the Ornia system has been activated, irrespective of age within the supported monitoring range.

"Services"

All digital and physical products, applications, platforms, support services, software, firmware updates, and communications provided by Ornia in connection with the Ornia System.

"Platform"

The Ornia mobile application and web platform, together with all associated cloud infrastructure, APIs, databases, and dashboards operated by Ornia.

"Clinical Partner"

A hospital, clinical research institution, academic organisation, or healthcare provider that has entered into a formal agreement with Ornia for the deployment of the Ornia System in a clinical or research context.

"Subscription"

A paid or free-tier access plan entitling the User to access specified features of the Ornia Platform.

"Intellectual Property"

All patents, patent applications, registered and unregistered designs, trade marks, service marks, trade names, domain names, copyright, database rights, know-how, trade secrets, algorithms, software code, proprietary methodologies, clinical data, and all other forms of intellectual or industrial property, whether registered or unregistered, of Ornia Limited.

"Applicable Law"

All applicable statutes, regulations, regulatory guidance, codes of practice, and judicial decisions of the Federal Republic of Nigeria and the United Kingdom, including the Nigeria Data Protection Act 2023, the UK GDPR, the Data Protection Act 2018, consumer protection regulations, and medical device regulations.

2. Acceptance and Binding Nature

By accessing or using any part of the Ornia System or Services, you confirm that:

• You have read, understood, and agree to be bound by these Terms and Conditions in their entirety;
• You have the legal capacity to enter into a binding agreement in your jurisdiction of residence or operation;
• Where you are acting on behalf of an institution, organisation, or Clinical Partner, you represent that you have the authority to bind that entity to these Terms;
• You accept our Privacy Policy (MAL-LEG-PP-001), which is incorporated into these Terms by reference and forms part of the agreement between us.

If you do not accept any part of these Terms, you must immediately cease use of all Ornia products and Services and contact us at info@rovatechltd.co.uk to arrange the return of any hardware and the deletion of any account data.

3. Medical Device Status and Clinical Disclaimer

Ornia expressly states the following material limitations, which Users accept as conditions of use:

• Physiological monitoring parameters are indicative in nature and may be subject to movement artefact, environmental interference, device fit variation, and sensor placement errors.
• Alert thresholds represent engineering judgements based on published neonatal physiological reference ranges and are not individually calibrated to the specific health status or medical history of any individual infant.
• Ornia does not diagnose conditions including SIDS, apnoea, hypoxia, cardiac arrhythmia, respiratory distress, or any other medical condition.
• In the event of any alert generated by Ornia, caregivers must independently assess the infant and, where there is any doubt, contact emergency medical services immediately.
• Ornia is not intended to enable unsupervised infant care. Parental and caregiver presence and vigilance remain the primary safeguard for infant safety.
• Ornia makes no representation that the use of Ornia reduces the statistical risk of SIDS, adverse neonatal events, or any medical outcome.

4. Permitted Use

Subject to your compliance with these Terms and payment of applicable Subscription fees, Ornia grants you a limited, non-exclusive, non-transferable, revocable licence to access and use the Ornia Platform and Services for the following purposes only:

• Personal, non-commercial monitoring of infants for whom you are the parent, legal guardian, or duly authorised carer;
• Clinical or research deployment under a validly executed Clinical Partner Agreement with Ornia;
• Internal evaluation and assessment for institutional procurement suitability, subject to the execution of an Evaluation Agreement.

All use of the Ornia System must comply with Applicable Law and with all applicable medical device, data protection, and consumer protection regulations in the User's jurisdiction.

5. Prohibited Conduct

The following are expressly prohibited and constitute material breach of these Terms:

6. Intellectual Property

All Intellectual Property in and relating to the Ornia System — including hardware designs, firmware, software code, algorithms, signal processing methodologies, clinical safety frameworks, user interface designs, patent applications, trade marks, brand assets, documentation, and training data — is the exclusive property of Ornia Limited and is protected by the intellectual property laws of Nigeria, the United Kingdom, and applicable international treaties.

Nothing in these Terms transfers, assigns, licences, or creates any right of ownership in any Intellectual Property of Ornia to the User, other than the limited use licence granted in Section 4.

Ornia has filed multiple provisional patent applications in respect of core Ornia System inventions. Any attempt to exploit, copy, replicate, or build upon patented or patent-pending technology without authorisation will be treated as patent infringement and pursued to the full extent of applicable law in all relevant jurisdictions.

7. Subscription, Payment, and Access

8. Limitation of Liability

9. Disclaimers and Warranties

The Ornia System and all associated Services are provided on an 'as is' and 'as available' basis. To the maximum extent permitted by Applicable Law, Ornia makes no representation or warranty that:

• The Ornia System will be continuously available, uninterrupted, error-free, or free from technical defects;
• The Ornia System is fit for any specific clinical, diagnostic, or therapeutic purpose;
• The physiological data generated is clinically accurate or equivalent to hospital-grade monitoring equipment;
• The use of the Ornia System will prevent, detect, or reduce the risk of any adverse infant health event;
• Ornia alerts will be delivered without latency in all network and connectivity conditions.

10. Clinical Research and Institutional Deployment

Where the Ornia System is deployed in a clinical research context:

• All clinical deployments require a validly executed Clinical Partner Agreement with Ornia prior to commencement of data collection;
• The Clinical Partner assumes responsibility for obtaining all requisite institutional ethics approvals and compliance with Good Clinical Practice (GCP) standards under ICH E6 (R2);
• Research data remains the joint property of Ornia and the Clinical Partner, subject to the terms of the applicable Clinical Partner Agreement;
• Publication of research findings incorporating Ornia data requires prior written approval from Ornia;
• The Ornia System must not be presented as a diagnostic or therapeutic device in any research publication unless Ornia has confirmed the applicable regulatory status in writing.

11. Regulatory Compliance Obligations

12. Force Majeure

Ornia shall not be liable for any failure or delay in performance where such failure or delay results from circumstances beyond its reasonable control, including acts of God, natural disaster, pandemic, war, terrorist act, civil unrest, government action, failure of internet infrastructure, third-party service provider failure, or labour dispute. Ornia will use reasonable endeavours to minimise the impact of such events on the continuity of core safety monitoring functionality.

13. Suspension and Termination

14. Confidentiality

Where Ornia discloses to a User any information marked as confidential or which a reasonable person would understand to be confidential, the recipient must hold such information in strict confidence, not disclose it to any third party without prior written consent from Ornia, and use it solely for the purpose for which it was disclosed.

15. Governing Law

These Terms shall be governed by:

• The laws of the Federal Republic of Nigeria, in respect of all Users domiciled or operating primarily in Nigeria and all commercial activities originating in Nigeria;
• The laws of England and Wales, in respect of all Users domiciled or operating primarily in the United Kingdom and all commercial activities originating in the United Kingdom.

16. Dispute Resolution

17. Amendments to These Terms

Ornia reserves the right to amend these Terms at any time. Where we make material amendments, we will provide registered Users with at least 30 days' written notice via email and by posting the amended Terms on our website. Your continued use of the Ornia System following the expiry of the notice period constitutes acceptance of the amended Terms.

18. General Provisions

19. Contact Information