Terms of Service

These Terms of Service ("Terms") govern your access to and use of the Qualiva software platform and related services ("Service") provided by QUALIVA LTD ("Qualiva", "we", "us", "our"), a company registered in England and Wales under the Companies Act 2006.

By accessing or using the Service, you agree to be bound by these Terms. If you are entering into these Terms on behalf of a company or other legal entity, you represent that you have authority to bind that entity.

1. The Service

Qualiva provides an AI-assisted quality management system (QMS) designed for pharmaceutical manufacturers, covering GMP compliance, deviation management, document control, stability studies, risk management, training management, and related modules as described at qualiva.ai/features.

We may update, modify, or add features to the Service at any time. We will give reasonable notice of any material changes that adversely affect your use.

2. Accounts and Access

You must provide accurate, complete information when creating an account. You are responsible for maintaining the confidentiality of your credentials and for all activity under your account. Notify us immediately at hello@qualiva.ai if you suspect unauthorised access.

You may not share login credentials between users. Each named user requires a separate seat. You may not use the Service to provide services to third parties unless agreed in writing.

3. Subscription and Payment

The Service is provided on a subscription basis. Fees are as set out in your Order Form or, where no Order Form exists, on the current pricing page at qualiva.ai/pricing. Prices are stated in USD and exclusive of VAT or applicable taxes.

Subscriptions are billed annually or monthly as selected. Annual subscriptions are non-refundable except as set out in Section 10 (Termination). Monthly subscriptions may be cancelled with 30 days' written notice.

If payment is not received within 14 days of the due date, we reserve the right to suspend access until payment is made. We will provide written notice before suspension.

4. Acceptable Use

You agree not to:

• Use the Service for any unlawful purpose or in violation of applicable regulations
• Attempt to gain unauthorised access to any part of the Service or its infrastructure
• Reverse engineer, decompile, or disassemble any part of the Service
• Upload content that infringes any third-party intellectual property rights
• Use the Service to transmit malware, spam, or any harmful code
• Resell or sublicense the Service without our written consent
• Use automated means to scrape or extract data from the Service

5. Your Data

You retain full ownership of all data you upload to or generate within the Service ("Customer Data"). We process Customer Data solely to provide and improve the Service as described in our Privacy Policy.

We do not use Customer Data to train AI or machine learning models. Customer Data is processed on infrastructure located in Nuremberg, Germany (Hetzner Cloud) and is not transferred outside the European Economic Area without your consent, except where required by law.

You are responsible for ensuring that your use of the Service complies with applicable data protection laws in your jurisdiction, including obtaining any necessary consents from data subjects.

6. AI Features

Certain features of the Service, including the Ask Qualiva AI assistant, deviation analysis, and document drafting, are powered by third-party AI models. Outputs from AI features are generated automatically and may contain errors or inaccuracies.

AI-generated content is provided as a decision-support tool only. You are solely responsible for reviewing, validating, and approving any AI-generated content before use in regulated activities. Qualiva is not liable for regulatory actions, product quality issues, or any other consequences arising from reliance on AI-generated outputs without adequate human review.

7. Intellectual Property

The Service, including all software, algorithms, designs, and content created by Qualiva, is owned by QUALIVA LTD and protected by applicable intellectual property laws. These Terms do not transfer any intellectual property rights to you.

You grant us a limited, non-exclusive licence to process your Customer Data solely as necessary to provide the Service.

If you provide feedback, suggestions, or ideas about the Service, you grant us a perpetual, irrevocable, royalty-free licence to use that feedback without restriction or obligation to you.

8. Confidentiality

Each party agrees to keep the other's Confidential Information (defined as non-public information designated as confidential or reasonably understood to be confidential) strictly confidential and not to disclose it to third parties without prior written consent, except as required by law.

Customer Data is your Confidential Information. Our pricing, technical documentation, and roadmap are our Confidential Information.

9. Warranties and Disclaimers

We warrant that the Service will perform materially in accordance with its documentation during the subscription term. If it does not, your sole remedy is for us to use commercially reasonable efforts to correct the non-conformity.

The Service is provided for decision-support purposes in a regulated industry. It does not replace qualified pharmaceutical professionals, regulatory consultants, or authorised persons (APs/QPs). We do not warrant that use of the Service will result in regulatory compliance or approval.

Except as expressly stated above, the Service is provided "as is" without warranty of any kind, express or implied, including merchantability, fitness for a particular purpose, or non-infringement.

10. Limitation of Liability

To the maximum extent permitted by applicable law, Qualiva's total liability to you for any claims arising out of or relating to these Terms or the Service shall not exceed the total fees paid by you in the 12 months preceding the claim.

In no event shall Qualiva be liable for indirect, incidental, special, consequential, or punitive damages, including loss of profits, revenue, data, or goodwill, even if advised of the possibility of such damages.

Nothing in these Terms limits or excludes liability for death or personal injury caused by negligence, fraud, or any other liability that cannot be limited by law.

11. Termination

Either party may terminate these Terms by written notice if the other party materially breaches these Terms and fails to cure the breach within 30 days of written notice.

You may cancel your subscription at any time. Upon cancellation, access continues until the end of the current billing period. We will provide a full export of your Customer Data in a standard machine-readable format within 30 days of termination. Data will be deleted from our systems within 60 days thereafter, unless legal obligations require otherwise.

We may suspend or terminate access immediately if we have reasonable grounds to believe you are using the Service in a manner that violates applicable law or poses a security risk.

12. Governing Law and Disputes

These Terms are governed by the laws of England and Wales. The courts of England and Wales have exclusive jurisdiction over any dispute arising out of or relating to these Terms, except where mandatory consumer protection laws in your jurisdiction provide otherwise.

Before commencing formal proceedings, the parties agree to attempt in good faith to resolve any dispute by escalating to senior management of each party for a period of 30 days.

13. General

Entire agreement. These Terms, together with any Order Form and our Privacy Policy, constitute the entire agreement between the parties regarding the Service and supersede all prior agreements and understandings.

Amendments. We may update these Terms from time to time. We will notify you of material changes by email or in-platform notice at least 30 days before the change takes effect. Continued use of the Service after that date constitutes acceptance of the updated Terms.

Severability. If any provision of these Terms is held invalid or unenforceable, the remaining provisions continue in full force.

Waiver. Failure to enforce any provision of these Terms does not constitute a waiver of that right.

Assignment. You may not assign these Terms without our prior written consent. We may assign these Terms in connection with a merger, acquisition, or sale of all or substantially all of our assets.

14. Contact

QUALIVA LTD
London, United Kingdom
Registered in England and Wales
hello@qualiva.ai