Terms of Service

You must be at least eighteen (18) years of age or the age of legal majority in your jurisdiction to use the Services.

If you use the Services on behalf of an organization, you represent that you have authority to bind that organization to these Terms.

You may not use the Services if prohibited by applicable law.

To access certain Services, you must create an account.

You agree to:

• provide accurate and complete information;
• maintain current account information;
• keep your credentials confidential;
• promptly notify Regxion of unauthorized account use;
• be responsible for activities conducted through your account, except to the extent caused by Regxion's breach of its obligations.

Regxion may require multi-factor authentication for certain accounts or service tiers.

Regxion AI provides cloud-based software and AI-powered tools designed to support regulatory, quality, clinical, manufacturing, labeling, pharmacovigilance, and related life sciences workflows.

The Services may include:

• AI document drafting
• Regulatory strategy assistance
• Document review
• Quality control review
• Retrieval-Augmented Generation (RAG)
• Regulatory intelligence
• Submission assembly
• Analytics
• AI agents
• APIs
• Workflow automation
• Future features introduced during your subscription.

Regxion may modify or improve the Services over time, provided such changes do not materially reduce the core functionality of the subscribed Services without reasonable notice.

Services may be offered under:

• Free Trial
• Individual
• Professional
• Team
• Enterprise
• Custom Enterprise

Each plan may have different features, usage limits, storage, support levels, and pricing.

Enterprise customers may also execute a separate Master Subscription Agreement ("MSA"), which will govern in the event of a conflict with these Terms.

You agree not to:

• violate applicable laws or regulations;
• infringe intellectual property rights;
• upload malicious code, viruses, or malware;
• interfere with the operation or security of the Services;
• attempt to gain unauthorized access to the Services or other users' accounts;
• reverse engineer, decompile, disassemble, or otherwise attempt to derive source code or model parameters, except where prohibited by applicable law;
• scrape, harvest, or systematically extract data from the Services without authorization;
• use the Services to generate fraudulent, deceptive, or misleading regulatory documentation;
• fabricate clinical, manufacturing, quality, or safety records;
• use automated means to abuse or overload the Services;
• use the Services to develop or train competing AI systems where prohibited by law or contract.

Violation of this section may result in suspension or termination of your account.

The Services incorporate artificial intelligence technologies, including generative AI, machine learning models, retrieval systems, and intelligent automation.

You acknowledge and agree that:

• AI-generated outputs are probabilistic and may contain inaccuracies, omissions, or outdated information;
• AI outputs are intended to assist—not replace—qualified human judgment;
• you are responsible for reviewing and validating AI-generated content before relying upon it;
• Regxion does not guarantee that AI-generated content will be accepted by any regulatory authority or suitable for any specific purpose.

Unless expressly agreed in writing, Customer Content is not used to train foundation models for the benefit of other customers.

You retain ownership of all content you upload, submit, or otherwise make available through the Services ("Customer Content").

By using the Services, you grant Regxion a limited, non-exclusive license to host, process, store, transmit, and analyze Customer Content solely to provide, secure, maintain, and improve the Services in accordance with these Terms and the applicable Privacy Policy.

You represent and warrant that you have all rights necessary to provide Customer Content and that doing so does not violate applicable law or third-party rights.

Subject to your compliance with these Terms, Regxion assigns to you any rights it may have in AI-generated content created specifically for you through your authorized use of the Services.

This assignment does not include ownership of:

• the Services;
• software;
• AI models;
• algorithms;
• documentation;
• templates;
• workflows;
• taxonomies;
• regulatory knowledge graphs;
• pre-existing Regxion intellectual property.

You are solely responsible for reviewing, validating, and determining the suitability of Generated Content for your intended use.

Regxion and its licensors retain all rights, title, and interest in and to the Services, including all software, APIs, documentation, AI models, trademarks, logos, copyrights, patents, trade secrets, and other intellectual property.

Except for the limited rights expressly granted under these Terms, no license or ownership rights are transferred to you.

Your use of the Services is subject to the Regxion AI Privacy Policy.

Where applicable, enterprise customers may also enter into a separate Data Processing Agreement governing the processing of personal data.

Regxion implements administrative, technical, and organizational safeguards designed to protect Customer Content.

While no system is completely secure, Regxion uses commercially reasonable security measures appropriate to the Services and continually works to enhance its security posture.

Users are responsible for safeguarding account credentials and maintaining appropriate endpoint security.

The Services may integrate with or link to third-party products and services.

Regxion is not responsible for the availability, security, functionality, or content of third-party services and does not endorse or warrant them.

Your use of third-party services is governed by the applicable third-party terms.

Paid subscriptions are billed according to the selected subscription plan or applicable Order Form.

Unless otherwise stated:

• fees are non-refundable;
• taxes are additional where applicable;
• subscription fees may change upon renewal with prior notice as required by law or contract.

Failure to pay undisputed fees may result in suspension or termination of the Services after reasonable notice.

Regxion may suspend access to the Services if reasonably necessary to:

• protect the security or integrity of the Services;
• investigate suspected misuse;
• comply with applicable law;
• address non-payment of undisputed fees;
• prevent harm to other users or the Services.

Where practicable, Regxion will provide advance notice and an opportunity to cure.

You may stop using the Services at any time.

Regxion may terminate or suspend your access for material breach of these Terms, unlawful use, repeated violations of the Acceptable Use Policy, or other grounds permitted by these Terms or applicable law.

Upon termination, your rights to access the Services cease, subject to any applicable data retrieval period.

The Services are provided "AS IS" and "AS AVAILABLE."

To the maximum extent permitted by law, Regxion disclaims all implied warranties, including warranties of merchantability, fitness for a particular purpose, and non-infringement.

Regxion does not guarantee uninterrupted availability, error-free operation, or acceptance of AI-generated content by regulatory authorities.

The Services do not constitute legal, medical, scientific, regulatory, or professional advice.

To the maximum extent permitted by law, Regxion shall not be liable for indirect, incidental, consequential, special, exemplary, or punitive damages, including loss of profits, revenue, goodwill, or data.

Except for liability that cannot be limited by law, Regxion's aggregate liability arising out of or relating to the Services shall not exceed the amounts paid by you to Regxion for the Services during the twelve (12) months preceding the event giving rise to the claim.

You agree to defend, indemnify, and hold harmless Regxion, its affiliates, officers, directors, employees, and agents from and against claims, damages, losses, liabilities, costs, and expenses arising from:

• your use of the Services;
• your Customer Content;
• your violation of these Terms;
• your infringement of third-party rights.

You agree to comply with all applicable export control, sanctions, and trade laws, including those administered by the United States and other applicable jurisdictions.

You may not use the Services in violation of such laws or make the Services available to prohibited persons or jurisdictions.

These Terms shall be governed by the laws of the State of Delaware, without regard to its conflict-of-law principles.

Unless otherwise required by applicable law, disputes arising under these Terms shall be subject to the exclusive jurisdiction of the state and federal courts located in Delaware.

These Terms constitute the entire agreement between you and Regxion regarding the Services, unless superseded by a separate written agreement such as an MSA.

If any provision is held unenforceable, the remaining provisions remain in full force and effect.

Regxion may update these Terms from time to time. Material changes will be communicated through the Services or by other reasonable means. Continued use of the Services after the effective date of updated Terms constitutes acceptance of the revised Terms.