TERMS OF USE

Verus FDA Advisors LLC

Last Updated: December 15, 2025

1. ACCEPTANCE OF TERMS

Welcome to Verus FDA Advisors LLC ("Verus," "we," "us," or "our"). These Terms of Use ("Terms") govern your access to and use of our website, services, and any related content, features, or functionality (collectively, the "Services").

BY ACCESSING OR USING OUR SERVICES, YOU AGREE TO BE BOUND BY THESE TERMS AND OUR PRIVACY POLICY. IF YOU DO NOT AGREE TO THESE TERMS, DO NOT ACCESS OR USE OUR SERVICES.

These Terms constitute a legally binding agreement between you (either an individual or an entity) and Verus FDA Advisors LLC. We reserve the right to modify these Terms at any time, and such modifications will be effective immediately upon posting. Your continued use of the Services after any changes constitutes acceptance of the revised Terms.

2. DESCRIPTION OF SERVICES

Verus FDA Advisors LLC provides regulatory consulting and advisory services related to the U.S. Food and Drug Administration (FDA), including but not limited to:

Regulatory strategy development
FDA submission preparation and support
Compliance consulting and gap analysis
Pre-submission meetings and regulatory correspondence
Quality systems consulting
Clinical trial consulting
Post-market surveillance support
Training and education services
Informational content and resources through our website

3. ELIGIBILITY AND REGISTRATION

3.1 Eligibility

You must be at least 18 years of age and have the legal capacity to enter into binding contracts to use our Services. By using our Services, you represent and warrant that you meet these requirements.

3.2 Account Registration

Certain features of our Services may require you to register for an account. When registering, you agree to:

Provide accurate, current, and complete information
Maintain and promptly update your account information
Maintain the security and confidentiality of your login credentials
Notify us immediately of any unauthorized access or security breach
Accept responsibility for all activities that occur under your account

You may not:

Create an account using false or misleading information
Create an account on behalf of another person without authorization
Use another person's account without permission
Sell, transfer, or share your account credentials

We reserve the right to suspend or terminate accounts that violate these Terms or are inactive for extended periods.

4. SCOPE OF SERVICES AND PROFESSIONAL RELATIONSHIP

4.1 Consulting Services

Our consulting services are provided pursuant to separate written agreements ("Engagement Letters" or "Service Agreements") that specify:

Scope of work and deliverables
Timeline and milestones
Fees and payment terms
Confidentiality obligations
Liability limitations
Dispute resolution procedures

These Terms supplement but do not replace any separate Service Agreement. In the event of conflict between these Terms and a Service Agreement, the Service Agreement shall control with respect to the specific engagement.

4.2 No Attorney-Client Relationship

Verus FDA Advisors LLC is a regulatory consulting firm, not a law firm. Nothing in these Terms or in our provision of Services creates an attorney-client relationship, and our Services do not constitute legal advice. You should consult with qualified legal counsel for legal advice regarding your specific circumstances.

4.3 No Guarantee of Regulatory Outcomes

While we strive to provide high-quality consulting services based on our knowledge and experience:

We do not guarantee any specific regulatory outcome or FDA decision
FDA decisions are made independently by the agency
Regulatory pathways and requirements are subject to change
Success depends on many factors beyond our control, including product characteristics, clinical data, manufacturing processes, and FDA discretion

4.4 Independent Judgment

Our advice and recommendations are based on our professional judgment and interpretation of applicable regulations. You are solely responsible for:

Making final decisions regarding regulatory strategy
Ensuring compliance with all applicable laws and regulations
The accuracy and completeness of information you provide to us
The quality, safety, and efficacy of your products

5. USE OF WEBSITE AND CONTENT

5.1 License to Use

Subject to your compliance with these Terms, we grant you a limited, non-exclusive, non-transferable, revocable license to access and use our website and Services for their intended purposes.

5.2 Restrictions

You agree NOT to:

Use the Services for any illegal or unauthorized purpose
Violate any applicable laws, regulations, or third-party rights
Interfere with or disrupt the Services or servers/networks connected to the Services
Attempt to gain unauthorized access to any portion of the Services
Use automated systems (bots, scrapers, crawlers) to access the Services
Copy, modify, distribute, sell, or lease any part of our Services
Reverse engineer or attempt to extract source code from our Services
Remove or alter any proprietary notices or labels
Impersonate any person or entity or misrepresent your affiliation
Upload or transmit viruses, malware, or other malicious code
Collect or harvest information about other users
Use the Services to send spam or unsolicited communications
Frame or mirror any content without our express written permission

5.3 Informational Content

Content on our website, including articles, guides, and resources, is provided for informational purposes only and does not constitute professional advice specific to your situation. You should not rely solely on website content for critical business or regulatory decisions without consulting with us directly or obtaining independent professional advice.

6. INTELLECTUAL PROPERTY RIGHTS

6.1 Our Intellectual Property

All content, features, and functionality of the Services, including but not limited to:

Text, graphics, logos, images, and photographs
Software, code, and technology
Trademarks, service marks, and trade names
Methodologies, processes, and know-how
Designs, compilations, and arrangements

are owned by Verus FDA Advisors LLC or our licensors and are protected by United States and international copyright, trademark, patent, trade secret, and other intellectual property laws.

6.2 Trademarks

The Verus FDA Advisors name, logo, and all related names, logos, product and service names, designs, and slogans are trademarks of Verus FDA Advisors LLC. You may not use these marks without our prior written permission. Other names, logos, and marks are the property of their respective owners.

6.3 Client Materials

When you engage our services, you may provide us with documents, data, information, and materials ("Client Materials"). You retain all ownership rights to your Client Materials. By providing Client Materials to us, you grant us a limited license to use, reproduce, and modify the Client Materials solely for the purpose of providing Services to you.

6.4 Work Product

Unless otherwise specified in a Service Agreement:

Deliverables and work product created specifically for you under an engagement become your property upon full payment
Pre-existing materials, templates, methodologies, and general knowledge remain our property
We retain the right to use general knowledge, skills, and experience gained during an engagement

6.5 Feedback

If you provide us with feedback, suggestions, or ideas about our Services ("Feedback"), you grant us an unrestricted, perpetual, royalty-free license to use, modify, and incorporate such Feedback into our Services without any obligation to you.

7. CONFIDENTIALITY

7.1 Mutual Confidentiality

We recognize that confidentiality is critical in regulatory consulting relationships. Both parties agree to maintain the confidentiality of information disclosed during the course of our relationship.

7.2 Separate Agreements

Specific confidentiality obligations are typically set forth in:

Non-Disclosure Agreements (NDAs)
Confidentiality provisions in Service Agreements
Our Privacy Policy

These Terms are supplemented by, and do not supersede, any separate confidentiality agreements.

7.3 Exceptions

Confidentiality obligations do not apply to information that:

Is or becomes publicly available through no breach of these Terms
Was rightfully in the possession of the receiving party prior to disclosure
Is independently developed without use of confidential information
Is required to be disclosed by law or regulatory authority

8. FEES AND PAYMENT

8.1 Consulting Fees

Fees for consulting services are specified in separate Service Agreements and may be based on:

Hourly rates
Fixed project fees
Retainer arrangements
Other mutually agreed-upon fee structures

8.2 Payment Terms

Unless otherwise specified in a Service Agreement:

Invoices are due within 30 days of the invoice date
Late payments may incur interest charges at the rate of 1.5% per month (or the maximum rate permitted by law, whichever is less)
We reserve the right to suspend services for non-payment
You are responsible for all collection costs, including reasonable attorney fees

8.3 Expenses

Unless otherwise specified, you will reimburse us for reasonable out-of-pocket expenses incurred in connection with providing Services, including travel, accommodation, and filing fees.

8.4 Taxes

Fees do not include applicable sales, use, value-added, or other taxes. You are responsible for all taxes (other than taxes on our income).

9. LIMITATION OF LIABILITY

9.1 Disclaimer of Warranties

TO THE MAXIMUM EXTENT PERMITTED BY LAW, THE SERVICES ARE PROVIDED "AS IS" AND "AS AVAILABLE" WITHOUT WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO:

WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE
WARRANTIES OF ACCURACY, COMPLETENESS, OR RELIABILITY
WARRANTIES OF TITLE OR NON-INFRINGEMENT
WARRANTIES ARISING FROM COURSE OF DEALING OR USAGE OF TRADE

WE DO NOT WARRANT THAT:

The Services will meet your requirements or expectations
The Services will be uninterrupted, timely, secure, or error-free
Any errors or defects will be corrected
The Services are free from viruses or harmful components

9.2 Limitation of Liability

TO THE MAXIMUM EXTENT PERMITTED BY LAW:

VERUS FDA ADVISORS LLC, ITS OFFICERS, DIRECTORS, EMPLOYEES, AGENTS, AND AFFILIATES SHALL NOT BE LIABLE FOR:

ANY INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, OR PUNITIVE DAMAGES
LOSS OF PROFITS, REVENUE, DATA, OR USE
LOSS OF BUSINESS OPPORTUNITIES OR GOODWILL
COSTS OF PROCUREMENT OF SUBSTITUTE SERVICES
REGULATORY DELAYS, DENIALS, OR ADVERSE DECISIONS

WHETHER ARISING FROM:

Contract, tort, strict liability, or otherwise
Even if we have been advised of the possibility of such damages

IN NO EVENT SHALL OUR TOTAL LIABILITY TO YOU EXCEED THE GREATER OF:

The amount you paid us in the 12 months preceding the claim, or
$5,000

9.3 Allocation of Risk

You acknowledge that the limitations in this Section 9 reflect a reasonable allocation of risk and are a fundamental element of the bargain between the parties. The Services would not be provided without these limitations.

9.4 Exceptions

Some jurisdictions do not allow the exclusion or limitation of certain warranties or liabilities. In such jurisdictions, our liability is limited to the maximum extent permitted by law.

10. INDEMNIFICATION

You agree to indemnify, defend, and hold harmless Verus FDA Advisors LLC and its officers, directors, employees, agents, affiliates, and partners from and against any claims, liabilities, damages, losses, costs, or expenses (including reasonable attorney fees) arising from or related to:

Your use or misuse of the Services
Your violation of these Terms
Your violation of any applicable laws or regulations
Your violation of any third-party rights
Information or materials you provide to us
Your products, including any claims of product liability, personal injury, or property damage
Any regulatory action or investigation related to your products or activities

We reserve the right to assume the exclusive defense and control of any matter subject to indemnification, in which case you agree to cooperate with our defense of such claim.

11. TERMINATION

11.1 Termination by You

You may terminate your use of the Services at any time by:

Ceasing to use the Services
Closing your account (if applicable)
Providing written notice of termination

11.2 Termination by Us

We reserve the right to suspend or terminate your access to the Services at any time, with or without cause, with or without notice, including if:

You violate these Terms
Your account is inactive for an extended period
We discontinue the Services or any portion thereof
We believe your actions may cause legal liability or harm to us or others
We are required to do so by law or regulatory authority

11.3 Effect of Termination

Upon termination:

Your right to access and use the Services immediately ceases
You remain liable for all fees and charges incurred prior to termination
Provisions that by their nature should survive termination shall survive, including confidentiality, intellectual property, indemnification, limitation of liability, and dispute resolution provisions

11.4 Service Agreement Termination

Termination of specific consulting engagements is governed by the applicable Service Agreement.

12. DISPUTE RESOLUTION

12.1 Governing Law

These Terms and any dispute arising from or related to these Terms or the Services shall be governed by the laws of [Insert State], without regard to its conflict of law provisions.

12.2 Informal Resolution

Before initiating formal proceedings, the parties agree to first attempt to resolve any dispute through good-faith negotiations. Either party may initiate negotiations by providing written notice to the other party describing the dispute and proposed resolution.

12.3 Arbitration

PLEASE READ THIS SECTION CAREFULLY. IT AFFECTS YOUR LEGAL RIGHTS.

If the parties cannot resolve a dispute through informal negotiations within 60 days, either party may initiate binding arbitration. The arbitration shall be conducted in accordance with the Commercial Arbitration Rules of the American Arbitration Association (AAA).

Key Terms:

Location: [Insert City, State]
Arbitrator: One arbitrator mutually agreed upon by the parties, or appointed by AAA if parties cannot agree
Costs: Each party shall bear its own costs and fees, with arbitrator fees split equally unless the arbitrator determines otherwise
Discovery: Limited to requests reasonably necessary to adjudicate the dispute
Award: The arbitrator's decision is final and binding, and judgment may be entered in any court of competent jurisdiction

12.4 Class Action Waiver

YOU AND VERUS FDA ADVISORS LLC AGREE THAT EACH MAY BRING CLAIMS AGAINST THE OTHER ONLY IN AN INDIVIDUAL CAPACITY AND NOT AS A PLAINTIFF OR CLASS MEMBER IN ANY PURPORTED CLASS OR REPRESENTATIVE ACTION.

12.5 Exceptions to Arbitration

Either party may seek injunctive or equitable relief in court to:

Protect intellectual property rights
Enforce confidentiality obligations
Prevent irreparable harm

12.6 Opt-Out

You may opt out of the arbitration provision by sending written notice to us within 30 days of first accepting these Terms. Your notice must include your name, address, and a clear statement that you wish to opt out of the arbitration provision.

13. MISCELLANEOUS PROVISIONS

13.1 Entire Agreement

These Terms, together with our Privacy Policy and any applicable Service Agreement, constitute the entire agreement between you and Verus FDA Advisors LLC regarding the Services and supersede all prior or contemporaneous understandings and agreements, whether written or oral.

13.2 Amendments

We reserve the right to modify these Terms at any time. Material changes will be effective upon posting on our website with an updated "Last Updated" date. Your continued use of the Services after changes are posted constitutes acceptance. For significant changes, we may provide additional notice such as email notification.

13.3 Waiver

Our failure to enforce any provision of these Terms shall not constitute a waiver of that provision or any other provision. Any waiver must be in writing and signed by an authorized representative.

13.4 Severability

If any provision of these Terms is found to be invalid or unenforceable, the remaining provisions shall remain in full force and effect. The invalid provision shall be modified to the minimum extent necessary to make it valid and enforceable.

13.5 Assignment

You may not assign or transfer these Terms or your rights hereunder without our prior written consent. We may assign these Terms without restriction. Any attempted assignment in violation of this provision is void.

13.6 No Third-Party Beneficiaries

These Terms are for the benefit of you and Verus FDA Advisors LLC only and do not create any third-party beneficiary rights.

13.7 Force Majeure

We shall not be liable for any failure or delay in performance due to circumstances beyond our reasonable control, including acts of God, war, terrorism, riots, embargoes, acts of civil or military authorities, fire, floods, accidents, pandemics, strikes, or shortages of transportation, facilities, fuel, energy, labor, or materials.

13.8 Notices

Notices to us must be sent to:

Verus FDA Advisors LLC
[Insert Address]
Email: [Insert Email]

Notices to you may be sent to the email address or physical address associated with your account and are deemed received when sent.

13.9 Relationship of Parties

The parties are independent contractors. Nothing in these Terms creates a partnership, joint venture, agency, employment, or franchise relationship.

13.10 Headings

Section headings are for convenience only and do not affect interpretation of these Terms.

13.11 Electronic Communications

You consent to receive communications from us electronically, and you agree that all agreements, notices, disclosures, and other communications that we provide electronically satisfy any legal requirement that such communications be in writing.

14. SPECIFIC DISCLAIMERS FOR REGULATORY CONSULTING

14.1 No Guarantee of Regulatory Approval

We provide consulting services to support your regulatory submissions and compliance efforts. However:

FDA decisions are made independently and at the agency's sole discretion
We cannot guarantee FDA approval, clearance, or any other favorable regulatory outcome
Regulatory requirements and interpretations may change
Each product and submission is evaluated on its individual merits

14.2 Client Responsibility

You remain solely responsible for:

The safety, efficacy, and quality of your products
Compliance with all applicable FDA regulations and guidance
The accuracy and completeness of information in regulatory submissions
Maintaining appropriate quality systems and records
Post-market surveillance and reporting
All decisions regarding regulatory strategy and submissions

14.3 Regulatory Knowledge

While we strive to stay current with FDA regulations and guidance:

Regulations and agency interpretations are subject to change
Our advice is based on information available at the time provided
You should independently verify the current status of regulations
Different FDA reviewers or centers may have different interpretations
Our advice does not constitute official FDA guidance

14.4 Outside Scope

Unless specifically engaged to do so, our Services do not include:

Legal advice or representation
Clinical trial conduct or monitoring
Laboratory testing or analytical services
Manufacturing operations or validation
Market research or commercial strategy
International regulatory submissions outside the United States

15. EXPORT CONTROL

You agree to comply with all applicable export control laws and regulations. You represent and warrant that you are not:

Located in a country subject to U.S. government embargo
On any U.S. government list of prohibited or restricted parties
Engaged in activities that would violate export control laws

16. ACCESSIBILITY

We are committed to making our website accessible to all users. If you experience difficulty accessing any part of our Services due to a disability, please contact us, and we will work with you to provide the information or services you seek through an alternative communication method.

17. CALIFORNIA USERS

If you are a California resident, you may have additional rights under California law. In accordance with California Civil Code Section 1789.3, California users are entitled to the following consumer rights notice:

The Complaint Assistance Unit of the Division of Consumer Services of the California Department of Consumer Affairs may be contacted in writing at 1625 North Market Blvd., Suite N 112, Sacramento, CA 95834, or by telephone at (800) 952-5210.

18. CONTACT INFORMATION

If you have questions about these Terms, please contact us:

Verus FDA Advisors LLC

Address: 174 Meeting Street, Charleston, SC 29401
Email: info@verusfda.com
Phone: 866-779-9719

19. ACKNOWLEDGMENT

BY USING OUR SERVICES, YOU ACKNOWLEDGE THAT YOU HAVE READ THESE TERMS OF USE, UNDERSTAND THEM, AND AGREE TO BE BOUND BY THEM. IF YOU DO NOT AGREE TO THESE TERMS, YOU MUST NOT ACCESS OR USE OUR SERVICES.

Last Updated: December 15, 2025