Terms & Conditions

Definitions

In these Terms and Conditions, the following definitions apply:

Acceptance and Binding Nature

By accessing or using any part of the SafeGuard 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 SafeGuard 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.

These Terms supersede all prior or contemporaneous representations, warranties, agreements, or understandings, whether oral or written, between you and Maluel, except where a separate written agreement signed by an authorised representative of Maluel expressly provides otherwise.

Medical Device Status and Clinical Disclaimer

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

• Physiological monitoring parameters generated by SafeGuard are indicative in nature. They may be subject to movement artefact, environmental interference, device fit variation, and sensor placement errors. They must not be interpreted as equivalent to hospital-grade clinical measurements.
• Alert thresholds configured within SafeGuard 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.
• SafeGuard does not diagnose conditions including but not limited to Sudden Infant Death Syndrome (SIDS), apnoea, hypoxia, cardiac arrhythmia, respiratory distress, or any other medical condition.
• In the event of any alert generated by SafeGuard, caregivers must independently assess the infant and, where there is any doubt, contact emergency medical services immediately. SafeGuard alerts do not replace the assessment obligation of the caregiver.
• SafeGuard is not intended to enable unsupervised infant care. Parental and caregiver presence and vigilance remain the primary safeguard for infant safety. SafeGuard is a supplementary monitoring aid.
• Maluel makes no representation that the use of SafeGuard reduces the statistical risk of SIDS, adverse neonatal events, or any medical outcome. Such representation has not been established through completed clinical investigation.

Regulatory status varies by jurisdiction. Users operating in markets where SafeGuard has not yet received applicable regulatory clearance or registration do so subject to the limitations applicable in their jurisdiction. Maluel will publish jurisdiction-specific regulatory status updates on its website as clearances are obtained.

Permitted Use

Subject to your compliance with these Terms and payment of applicable Subscription fees, Maluel grants you a limited, non-exclusive, non-transferable, revocable licence to access and use the SafeGuard 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 Maluel;
• Internal evaluation and assessment for the purposes of determining institutional procurement suitability, subject to the execution of an Evaluation Agreement.

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

Prohibited Conduct

The following are expressly prohibited and constitute material breach of these Terms, potentially giving rise to immediate termination of your access and legal proceedings:

5.1 Technical Prohibitions

• Reverse engineering, decompiling, disassembling, or attempting to extract the source code, firmware, algorithms, or underlying architecture of any SafeGuard hardware, software, or platform;
• Interfering with, circumventing, or disabling any security, encryption, access control, or integrity mechanism within the SafeGuard system;
• Modifying, adapting, translating, or creating derivative works from any part of the SafeGuard system without prior written authorisation from Maluel;
• Injecting code, malware, or any harmful component into SafeGuard hardware, firmware, or the Platform;
• Using automated tools, bots, scripts, or scraping mechanisms to extract data from the SafeGuard Platform;
• Attempting to probe, scan, or test the vulnerability of SafeGuard infrastructure without a valid and current penetration testing agreement executed with Maluel.

5.2 Data and Privacy Prohibitions

• Accessing, collecting, processing, or sharing the personal data or physiological data of any infant for whom you are not the authorised caregiver, without explicit consent and authorisation;
• Sharing SafeGuard account credentials, access tokens, or authentication details with any unauthorised third party;
• Using SafeGuard data for purposes of surveillance, profiling, behavioural analysis, or any purpose beyond the monitoring of the infant for whose benefit the system was activated;
• Processing infant health data in a manner inconsistent with the consent provided and with Maluel's Privacy Policy.

5.3 Commercial Prohibitions

• Reselling, sublicensing, renting, lending, or otherwise making available the SafeGuard system or any part thereof to any third party without a valid reseller agreement executed with Maluel;
• Using SafeGuard to develop, benchmark, or improve a competing product or service;
• Representing to any third party that you are authorised to act on behalf of Maluel, or that you are an agent, representative, or affiliate of Maluel, without express written authorisation;
• Making false, misleading, or unsubstantiated claims about SafeGuard capabilities in a commercial or public context.

5.4 Regulatory and Safety Prohibitions

• Using SafeGuard in any manner that violates applicable medical device regulations, clinical research ethics requirements, or data protection law;
• Using SafeGuard as the sole or primary safety system in a clinical environment without appropriate clinical oversight infrastructure and without a valid Clinical Partner Agreement;
• Altering, overriding, or disabling any alert threshold or safety mechanism in a manner not permitted by documented caregiver customisation features.

Intellectual Property

All Intellectual Property in and relating to SafeGuard, including but not limited to 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 Maluel 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 Maluel to the User, other than the limited use licence granted in Section 4. Your use of the SafeGuard system does not grant you any rights in the underlying technology, inventions, or proprietary methodologies.

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

Subscription, Payment, and Access

7.1 Free Core Safety Tier

7.2 Paid Subscription Features

Advanced features, including but not limited to extended historical data access, clinical trend analytics, healthcare professional integration, research data export, and multi-device management, may be offered under paid Subscription plans. Subscription terms, pricing, and feature inclusions will be published on our website and may be updated subject to Section 17.

7.3 Payment and Billing

Paid Subscriptions are billed in advance on the applicable billing cycle. All payments are processed by certified third-party payment processors. Maluel does not store or have access to your full payment card details. Subscription fees are non-refundable except where required by Applicable Law or as expressly provided in our Refund Policy.

7.4 Suspension and Termination for Non-Payment

Where a paid Subscription lapses due to non-payment, access to paid features will be suspended. Maluel will not suspend, restrict, or disable core safety monitoring functionality solely due to payment failure. Access to paid features will be restored within 24 hours of successful payment.

Limitation of Liability

8.1 Exclusion of Consequential Loss

To the maximum extent permitted by Applicable Law, Maluel, its directors, officers, employees, contractors, advisors, and affiliates shall not be liable for:

• Any indirect, special, incidental, consequential, or punitive damages;
• Loss of profit, revenue, business, data, or anticipated savings;
• Personal injury or loss of life, except where caused by the gross negligence or wilful misconduct of Maluel;
• Any claim arising from a User's failure to follow SafeGuard product documentation, setup guidance, or caregiver instructions;
• Any outcome resulting from the use of SafeGuard in a manner contrary to its documented purpose or these Terms;
• Losses arising from network failure, connectivity interruption, device battery depletion, or other external factors beyond Maluel's reasonable control.

8.2 Cap on Liability

Subject to Section 8.3, Maluel's total aggregate liability to any User or institutional party for all claims arising from or relating to these Terms or the use of SafeGuard, whether in contract, tort, statute, or otherwise, shall not exceed the greater of: (a) the total Subscription fees paid by that User in the twelve months immediately preceding the event giving rise to the claim; or (b) one hundred United States Dollars (USD 100.00).

8.3 Non-Excludable Liability

Nothing in these Terms excludes or limits liability which cannot be excluded or limited by Applicable Law, including liability for death or personal injury caused by gross negligence or fraud on the part of Maluel, or liability for breach of statutory consumer protection rights where such liability is non-excludable.

8.4 Indemnification by User

You agree to indemnify, defend, and hold harmless Maluel and its directors, officers, employees, contractors, and advisors from and against any and all claims, demands, actions, proceedings, losses, damages, costs, and expenses (including reasonable legal fees) arising from or relating to:

• Your breach of any provision of these Terms;
• Your misuse of SafeGuard products or Services beyond their documented scope and purpose;
• Your violation of any Applicable Law;
• Your infringement of the rights of any third party, including intellectual property rights;
• Any false or misleading representation you make about SafeGuard in a commercial or public context.

Disclaimers and Warranties

SafeGuard and all associated Services are provided on an 'as is' and 'as available' basis. To the maximum extent permitted by Applicable Law, Maluel makes no representation or warranty, express or implied, including but not limited to:

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

These disclaimers do not affect any rights you may have under applicable consumer protection legislation that cannot be excluded by contract.

Clinical Research and Institutional Deployment

Where SafeGuard is deployed in a clinical research context, the following additional terms apply and, in the event of conflict with the general terms of this document, shall prevail:

• All clinical deployments require a validly executed Clinical Partner Agreement with Maluel prior to commencement of data collection;
• The Clinical Partner assumes responsibility for obtaining all requisite institutional ethics approvals, informed consent from research participants, and compliance with Good Clinical Practice (GCP) standards under ICH E6 (R2) or applicable local equivalent;
• Research data generated using SafeGuard in a clinical context remains the joint property of Maluel and the Clinical Partner, subject to the terms of the applicable Clinical Partner Agreement;
• Publication of research findings incorporating SafeGuard data or methodology requires prior written approval from Maluel, which shall not be unreasonably withheld, and appropriate attribution to Maluel as the technology provider;
• SafeGuard must not be presented as a diagnostic, therapeutic, or certified clinical device in any research publication, regulatory submission, or funding application unless Maluel has confirmed the applicable regulatory status in writing;
• Clinical Partners must maintain appropriate product liability insurance coverage for the deployment period.

Regulatory Compliance Obligations

11.1 User Obligations

• You are responsible for determining and complying with all medical device, data protection, and consumer protection regulations applicable to your use of SafeGuard in your jurisdiction;
• In jurisdictions where SafeGuard has not yet obtained applicable regulatory clearance, you must independently satisfy yourself that your use complies with local law before proceeding;
• Healthcare institutions deploying SafeGuard must ensure that use is consistent with applicable clinical governance frameworks and patient safety standards.

11.2 Adverse Event Reporting

Where a User becomes aware of a serious adverse event involving SafeGuard, including device failure during a critical monitoring event, erroneous alert generation associated with harm, or any incident which a reasonable person would consider material to product safety, the User must notify Maluel at info@rovatechltd.co.uk within 72 hours. Maluel will investigate and report to applicable regulatory authorities in accordance with statutory post-market surveillance obligations.

11.3 Cooperation with Regulatory Bodies

Where required by any lawful regulatory requirement or formal request from a competent authority, including NAFDAC, the MHRA, the EU Commission, or the United States FDA, Maluel may be required to disclose certain product safety data, adverse event reports, or device performance records. Such disclosures will be made to the minimum extent necessary and in compliance with applicable data protection obligations.

Force Majeure

Maluel shall not be liable for any failure or delay in performance of its obligations under these Terms where such failure or delay results from circumstances beyond its reasonable control, including but not limited to acts of God, natural disaster, pandemic, war, terrorist act, civil unrest, government action or regulatory change, failure of internet infrastructure, third-party service provider failure, or labour dispute.

Maluel will use reasonable endeavours to minimise the impact of such events on the continuity of core safety monitoring functionality and will notify affected Users as soon as practicable.

Suspension and Termination

13.1 Termination by User

You may terminate your SafeGuard account at any time by contacting us at info@rovatechltd.co.uk. Termination will result in the deactivation of your account, the cessation of monitoring services, and the initiation of our data deletion process in accordance with our Privacy Policy. Core safety functionality will continue until the device is manually deactivated.

13.2 Termination or Suspension by Maluel

Maluel may suspend or terminate your access to the SafeGuard Platform and Services, with or without notice, in the following circumstances:

• Material or repeated breach of these Terms;
• Conduct that poses a risk to the safety, security, or integrity of the Platform or to other Users;
• Provision of false or misleading information during registration or use;
• Use of SafeGuard in a manner that violates Applicable Law;
• Insolvency, bankruptcy, or analogous proceedings of an institutional User;
• A regulatory requirement to cease service provision in a particular jurisdiction.

Where suspension or termination is for reasons of safety or legal compliance, it may take effect immediately without prior notice.

13.3 Survival

The following provisions survive termination of these Terms: Section 6 (Intellectual Property), Section 8 (Limitation of Liability), Section 9 (Disclaimers), Section 15 (Governing Law), Section 16 (Dispute Resolution), and any provisions which by their nature are intended to survive.

Confidentiality

Where Maluel discloses to a User, or a User has access to, any information marked as confidential, disclosed in circumstances of confidence, or which a reasonable person would understand to be confidential (including but not limited to product roadmaps, engineering specifications, pricing structures, clinical data, and investor information), the recipient must:

• Hold such information in strict confidence;
• Not disclose it to any third party without prior written consent from Maluel;
• Use it solely for the purpose for which it was disclosed;
• Apply at least the same degree of protection as the recipient applies to its own confidential information, and no less than reasonable care.

This obligation does not apply to information which: (a) is or becomes publicly available through no fault of the recipient; (b) was lawfully in the recipient's possession before disclosure; (c) is independently developed without reference to the confidential information; or (d) must be disclosed by law, provided the recipient gives Maluel the earliest possible notice and cooperates in seeking protective measures.

Governing Law

These Terms and Conditions and any dispute or claim arising from or in connection with them, or their subject matter, formation, or validity (including non-contractual disputes or claims), shall be governed by and construed in accordance with:

• 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.

Where a User operates across both jurisdictions, the governing law shall be determined by the jurisdiction in which the majority of relevant commercial activity occurs, as agreed by the parties or determined by a competent tribunal.

Dispute Resolution

16.1 Good Faith Negotiation

In the event of any dispute, controversy, or claim arising from or relating to these Terms or the use of SafeGuard, the parties shall first attempt in good faith to resolve the matter through direct negotiation. The party raising the dispute shall give written notice to the other party specifying the nature of the dispute with reasonable particularity. The parties shall have 30 days from the date of such notice to attempt resolution.

16.2 Mediation

Where direct negotiation fails to resolve the dispute within the period set out in Section 16.1, either party may refer the dispute to non-binding mediation. The mediator shall be agreed between the parties or, failing agreement within 14 days, appointed by the Lagos Court of Arbitration or the Centre for Effective Dispute Resolution (CEDR) in London, as applicable to the governing jurisdiction.

16.3 Arbitration

Where mediation fails or is declined, any unresolved dispute shall be finally settled by binding arbitration in accordance with the Arbitration and Conciliation Act 2023 of Nigeria (for Nigerian disputes) or the Arbitration Act 1996 of England and Wales (for UK disputes). Arbitration proceedings shall be conducted in English, in Lagos or London respectively, before a sole arbitrator agreed by the parties or appointed by the relevant institution. The arbitrator's decision shall be final and binding.

16.4 Emergency Relief

Nothing in this Section prevents either party from seeking urgent injunctive or interim relief from a court of competent jurisdiction where necessary to prevent imminent irreparable harm, including in respect of intellectual property infringement or breach of confidentiality.

Amendments to These Terms

Maluel 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. For non-material amendments such as typographical corrections or clarifications that do not alter User rights, we may update the Terms without prior notice.

Your continued use of SafeGuard following the expiry of the notice period constitutes acceptance of the amended Terms. If you do not accept the amendments, you must cease use of the Services and notify us in writing. We will process any consequential account closure and data deletion request without prejudice.

All prior versions of these Terms are archived and available upon request. The version history is maintained in our document management system for regulatory and audit purposes.

General Provisions

18.1 Entire Agreement

These Terms, together with the Privacy Policy and any applicable Clinical Partner Agreement, Evaluation Agreement, or Subscription Agreement, constitute the entire agreement between you and Maluel in relation to the subject matter hereof, and supersede all prior agreements, representations, and understandings.

18.2 Severability

If any provision of these Terms is held by a court or arbitral tribunal to be invalid, unlawful, void, or unenforceable in whole or in part, that provision shall be severed from these Terms and the remaining provisions shall continue in full force and effect.

18.3 No Waiver

Maluel's failure to enforce any right or provision of these Terms shall not constitute a waiver of that right or provision. Any waiver must be in writing and signed by an authorised representative of Maluel to be effective.

18.4 Assignment

You may not assign, transfer, sub-licence, or delegate any right or obligation under these Terms without Maluel's prior written consent. Maluel may assign these Terms, or any of its rights or obligations hereunder, to an affiliate, successor, or acquirer of all or substantially all of Maluel's business or assets, without your consent, provided that Maluel provides you with reasonable notice.

18.5 No Third Party Rights

These Terms confer no rights on any third party unless expressly stated. The Contracts (Rights of Third Parties) Act 1999 of England and Wales does not apply to these Terms.

18.6 Notices

All notices required or permitted under these Terms must be in writing and delivered by email to the addresses below, or by courier or registered mail to the parties' principal business addresses. Notices take effect on the date of confirmed receipt.

Contact Information

For all queries, notices, complaints, regulatory correspondence, or legal process relating to these Terms and Conditions, please contact: