Terms and Conditions — PharmaRegAI

Effective Date: May 27, 2026 Last Updated: May 27, 2026 Version: 1.0

PharmaRegAI ("PharmaRegAI," "Company," "We," "Us," or "Our") is a USA-established regulatory technology and enterprise software company. These Terms and Conditions ("Agreement") govern Your access to and use of pharmaregai.com, the PharmaRegAI Portal, eQMS platforms, and all associated software, tools, content, and services (collectively, the "Services" or "Platform").

By accessing, registering for, or using any part of Our Services, You — either as an individual user or as an authorized representative of a company or business entity ("You" or "User") — agree to be bound by this Agreement. If You do not accept these terms, You must not access or use the Services.

In the event of a conflict between these Terms, Our Privacy Policy, or any executed Order Form or Service Agreement, the following order of precedence applies: (1) Order Form or Service Agreement, (2) Privacy Policy, (3) these Terms and Conditions.

1. Definitions

For purposes of this Agreement:

"Services" means the PharmaRegAI Portal, eQMS platform, custom enterprise solutions, regulatory intelligence features, AI-powered tools, and all other software, platforms, and professional services provided by PharmaRegAI.
"Platform" means pharmaregai.com and all associated web applications, APIs, portals, and digital environments operated by PharmaRegAI.
"Content" means all data, text, documents, reports, analytics, analysis outputs, summaries, recommendations, graphics, and other materials made available through the Services.
"Licensed Content" means proprietary regulatory intelligence outputs, inspection analyses, AI-generated summaries, CAPA recommendations, investigator profiles, and any other Platform-delivered content representing PharmaRegAI's original compilation, intellectual work, or processed outputs.
"User Content" means any text, data, documents, files, or other materials that You submit, upload, or input into the Services.
"Order Form" means a written or electronic order agreement specifying the Services purchased, pricing, term, and other applicable terms.
"Authorized Users" means individuals within Your organization who are granted access to the Services under Your account.

2. Account Registration and Access

2.1 Registration

Access to certain features of the Platform requires account registration. When registering, You agree to:

Provide accurate, complete, and current information.
Maintain and promptly update Your account information.
Keep Your login credentials confidential and not share them with any third party.
Notify PharmaRegAI immediately of any unauthorized access or breach of Your account security.

PharmaRegAI reserves the right to reject, suspend, or terminate any account at its discretion.

2.2 Authorized Users

If You are accessing the Services on behalf of a business entity, You represent and warrant that You have authority to bind that entity to this Agreement. You are responsible for ensuring that all Authorized Users within Your organization comply with this Agreement.

2.3 Account Security

You bear full responsibility for all activity conducted under Your account. PharmaRegAI is not liable for any loss or damage arising from unauthorized account access resulting from Your failure to maintain credential security.

3. Permitted Use of Services

3.1 License Grant

Subject to the terms of this Agreement, PharmaRegAI grants You a limited, non-exclusive, non-transferable, revocable license to access and use the Services solely for Your internal legitimate business purposes during the applicable subscription or engagement term.

3.2 Acceptable Use

You agree to use the Services only in a manner consistent with applicable laws, regulations, and industry standards. Specifically, You agree to:

Access and use the Services solely for internal business operations, compliance management, quality system support, regulatory learning, or purposes expressly authorized under an Order Form.
Ensure all User Content You submit is accurate, lawfully owned or licensed by You, and does not infringe any third-party intellectual property rights.
Comply with all applicable laws, including data privacy laws, pharmaceutical regulations, intellectual property laws, anti-spam laws, and export control regulations.
Maintain updated contact information in the Platform.

3.3 Restrictions

You agree not to, and not to permit any Authorized User or third party to:

Use the Services to build, develop, train, or enhance any competing product, platform, or regulatory intelligence tool.
Upload Licensed Content or any outputs generated by PharmaRegAI's AI systems into third-party artificial intelligence systems, machine learning models, or large language model training datasets.
Systematically download, extract, scrape, cache, or reproduce Licensed Content beyond individual permitted use, whether manually or through automated means, scripts, bots, or crawlers.
Reverse engineer, decompile, disassemble, or otherwise attempt to derive the source code, structure, or underlying logic of the Platform or its AI systems.
Share, sublicense, resell, or redistribute access to the Services without prior written authorization from PharmaRegAI.
Circumvent, disable, or interfere with security features, access controls, or integrity protections of the Platform.
Misrepresent Your identity, affiliation, or authorization when using the Services.
Use the Services in any way that could damage, disrupt, overburden, or impair the Platform's performance or security.
Upload or transmit content that contains viruses, malware, ransomware, harmful scripts, or any disruptive code.
Use the Services for any purpose that is unlawful, fraudulent, deceptive, or harmful.

4. Proprietary Content and Intellectual Property

4.1 PharmaRegAI Intellectual Property

All intellectual property rights in the Services, Platform, Licensed Content, software, AI systems, algorithms, databases, regulatory intelligence outputs, and related materials are owned by or licensed to PharmaRegAI. Nothing in this Agreement transfers ownership of any PharmaRegAI intellectual property to You.

Trademarks, service marks, logos, and trade names associated with PharmaRegAI are the exclusive property of PharmaRegAI. You may not use or display such marks without prior written consent.

4.2 Licensed Content — Scope and Restrictions

Licensed Content delivered through the Services:

Is an original compilation protected under applicable copyright law.
Represents substantial investment in data acquisition, processing, AI model development, and regulatory domain expertise.
Is proprietary and confidential information of PharmaRegAI.

Permitted use of Licensed Content is limited to:

Internal review, analysis, and application for legitimate compliance, quality, or operational purposes within Your organization.
Reference in internal compliance documentation, CAPA records, or quality reviews, with appropriate attribution.

Prohibited uses of Licensed Content include:

Distribution to third parties, external consultants, or affiliates not covered under an applicable Order Form.
Use as training data or inputs for AI or machine learning applications.
Mass download, archiving, or reproduction beyond individual use.

4.3 User Content

As between PharmaRegAI and You, all User Content remains owned by You. By submitting User Content to the Platform, You grant PharmaRegAI a non-exclusive, worldwide, royalty-free license to process, store, analyze, and use Your User Content solely to deliver the Services and improve Platform performance. You represent that You have all rights necessary to grant this license and that Your User Content does not violate any applicable law or third-party rights.

4.4 Feedback

If You provide suggestions, ideas, or feedback regarding the Services ("Feedback"), PharmaRegAI may use such Feedback without restriction or compensation to You.

5. eQMS and Custom Development Services

5.1 Custom Deliverables

For engagements involving customized eQMS development or bespoke enterprise application development, the specific deliverables, timelines, acceptance criteria, ownership terms, and payment schedules will be defined in an executed Order Form or Statement of Work ("SOW").

5.2 Client Ownership

Where an Order Form or SOW explicitly confirms client ownership of custom-developed source code and associated deliverables, such ownership transfers to You upon full payment of applicable fees. PharmaRegAI retains no continuing rights to client-owned deliverables once transferred, except for pre-existing components, libraries, or frameworks that remain subject to their original licensing terms.

5.3 Platform Components Retained by PharmaRegAI

Notwithstanding client ownership of bespoke deliverables, PharmaRegAI retains all rights to:

Core Platform infrastructure, AI models, and proprietary frameworks.
Regulatory intelligence databases and processed data assets.
Generic software components, libraries, and methodologies not specifically developed for a client.

6. Fees, Payment, and Billing

6.1 Fees

Fees for Services are specified in the applicable Order Form or stated pricing schedule. PharmaRegAI reserves the right to modify pricing with advance written notice as specified in the Order Form.

6.2 Payment Terms

Unless otherwise specified in an Order Form:

Invoices are due within thirty (30) days of issuance.
Overdue balances will accrue interest at 1.5% per month or the maximum rate permitted by applicable law, whichever is lower.

6.3 Taxes

You are responsible for all applicable taxes, duties, levies, or governmental charges associated with Your use of the Services, excluding taxes on PharmaRegAI's income.

6.4 No Refunds on Early Termination

Unless expressly stated in an Order Form, fees paid are non-refundable if You terminate Services before the end of the subscription or engagement term.

7. Term and Termination

7.1 Term

This Agreement commences upon Your first access to or use of the Services and remains in effect for the duration of Your active account or any Order Form, whichever is longer.

7.2 Termination by You

You may terminate this Agreement at any time by ceasing use of the Services and, if applicable, notifying PharmaRegAI in writing. Termination before the end of an Order Form term does not relieve You of outstanding payment obligations.

7.3 Termination by PharmaRegAI

PharmaRegAI may terminate this Agreement or suspend Your access:

Immediately if You materially breach any provision of this Agreement and fail to cure the breach within five (5) business days of written notice.
Immediately for breach of Sections 3.3, 4.1, or 4.2.
Upon thirty (30) days' written notice for any reason, in which case PharmaRegAI will refund prorated fees for unused Service periods.
Immediately if We reasonably determine Your use poses a security, legal, or reputational risk to PharmaRegAI or other users.

7.4 Effect of Termination

Upon termination:

Your license to access and use the Services immediately ceases.
You must cease all use of Licensed Content and delete or return copies in Your possession.
Sections 4, 6, 8, 9, 10, 11, and 12 survive termination and remain binding.

8. Confidentiality

8.1 Obligations

Each party agrees to maintain the confidentiality of the other party's Confidential Information and not to disclose it to any third party without prior written consent. "Confidential Information" means any non-public business, technical, financial, or operational information disclosed in connection with this Agreement and marked or understood to be confidential.

8.2 Exclusions

Confidentiality obligations do not apply to information that:

Is or becomes publicly available without breach of this Agreement.
Was independently known to the receiving party without restriction prior to disclosure.
Is disclosed with the prior written approval of the disclosing party.
Is required to be disclosed by applicable law or court order, provided prompt advance notice is given to the disclosing party where legally permitted.

9. Warranty Disclaimer

THE SERVICES, PLATFORM, AND LICENSED CONTENT ARE PROVIDED ON AN "AS IS" AND "AS AVAILABLE" BASIS. PHARMAREGAI EXPRESSLY DISCLAIMS ALL WARRANTIES, WHETHER EXPRESS, IMPLIED, STATUTORY, OR OTHERWISE, INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, ACCURACY, COMPLETENESS, NON-INFRINGEMENT, AND UNINTERRUPTED OR ERROR-FREE OPERATION.

PHARMAREGAI DOES NOT WARRANT THAT THE SERVICES WILL MEET YOUR SPECIFIC COMPLIANCE, REGULATORY, OR BUSINESS REQUIREMENTS, OR THAT ANY REGULATORY INTELLIGENCE, AI-GENERATED OUTPUT, ROOT CAUSE RECOMMENDATION, OR CAPA GUIDANCE CONSTITUTES LEGAL, REGULATORY, OR PROFESSIONAL ADVICE. ALL OUTPUTS SHOULD BE INDEPENDENTLY EVALUATED BY QUALIFIED PROFESSIONALS BEFORE OPERATIONAL APPLICATION.

10. Limitation of Liability

10.1 Exclusion of Consequential Damages

TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, PHARMAREGAI SHALL NOT BE LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL, PUNITIVE, CONSEQUENTIAL, OR EXEMPLARY DAMAGES, INCLUDING LOSS OF REVENUE, PROFITS, DATA, GOODWILL, OR BUSINESS OPPORTUNITY, EVEN IF PHARMAREGAI HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

10.2 Aggregate Liability Cap

PHARMAREGAI'S TOTAL CUMULATIVE LIABILITY ARISING OUT OF OR RELATED TO THIS AGREEMENT, REGARDLESS OF THE FORM OF CLAIM OR LEGAL THEORY, SHALL NOT EXCEED THE GREATER OF: (A) THE TOTAL FEES PAID BY YOU TO PHARMAREGAI IN THE TWELVE (12) MONTHS IMMEDIATELY PRECEDING THE CLAIM, OR (B) USD $5,000.

10.3 Materiality

THE LIMITATIONS IN THIS SECTION REFLECT A FAIR ALLOCATION OF RISK AND ARE A MATERIAL INDUCEMENT FOR PHARMAREGAI TO ENTER INTO THIS AGREEMENT. THEY SHALL SURVIVE A DETERMINATION BY A COURT THAT ANY EXCLUSIVE REMEDY FAILS ITS ESSENTIAL PURPOSE.

11. Indemnification

You agree to defend, indemnify, and hold PharmaRegAI and its officers, directors, employees, agents, and affiliates harmless from and against any claims, damages, losses, liabilities, costs, and expenses (including reasonable attorneys' fees) arising from or related to:

Your use of the Services in violation of this Agreement or applicable law.
Any User Content You submit, including infringement of any third-party intellectual property rights or breach of applicable regulations.
Your breach of any representation, warranty, or obligation under this Agreement.
Any claim by an Authorized User or third party resulting from Your use of the Services.

12. General Provisions

12.1 Governing Law and Jurisdiction

This Agreement is governed by and construed in accordance with the laws of the United States of America. Disputes arising from or related to this Agreement shall be resolved in competent federal or state courts in the United States, and both parties consent to such exclusive jurisdiction. Both parties waive any right to a jury trial in connection with any dispute arising from this Agreement.

12.2 Changes to This Agreement

PharmaRegAI may update this Agreement at any time by posting the revised version on the Platform with an updated effective date. Continued use of the Services following such posting constitutes Your acceptance of the revised Agreement. We will provide advance notice of material changes where practicable.

12.3 Assignment

You may not assign or transfer this Agreement or any of Your rights or obligations under it without PharmaRegAI's prior written consent. PharmaRegAI may assign this Agreement to an affiliate or in connection with a merger, acquisition, or asset sale without Your consent.

12.4 Severability

If any provision of this Agreement is found to be unenforceable or invalid, it will be modified to the minimum extent necessary to make it enforceable. The remaining provisions will continue in full force.

12.5 Waiver

Failure by either party to enforce any provision of this Agreement does not constitute a waiver of that party's right to enforce it in the future.

12.6 Subcontractors

PharmaRegAI reserves the right to engage subcontractors or third-party service providers to deliver any part of the Services without prior notice to You, provided such parties are subject to appropriate confidentiality and data protection obligations.

12.7 Entire Agreement

This Agreement, together with any applicable Order Form, SOW, and Privacy Policy, constitutes the entire agreement between the parties regarding its subject matter and supersedes all prior or contemporaneous understandings, representations, and agreements.

12.8 Notices

Notices to PharmaRegAI under this Agreement must be delivered in writing to:

PharmaRegAI Email: shrey@pharmaregai.com Website: www.pharmaregai.com

Notices to You will be delivered to the email address or contact information registered in Your account. You agree to keep Your contact information current at all times.

12.9 Attorney's Fees

In any action to enforce this Agreement, the prevailing party shall be entitled to recover reasonable attorneys' fees and costs in addition to any other damages awarded.

12.10 Force Majeure

Neither party shall be liable for failure or delay in performance resulting from causes beyond its reasonable control, including acts of God, natural disasters, pandemics, government actions, cyberattacks on critical infrastructure, or internet service failures, provided that the affected party provides prompt notice and resumes performance as soon as practicable.

*These Terms and Conditions are effective as of May 27, 2026.*