Terms of Service

These Terms of Service (“Terms”) govern your access to and use of the SubstantiatePro service, including the web application, APIs, and related materials (collectively, the “Service”) provided by Friese Regulatory LLC (“Company,” “we,” “our,” or “us”). By accessing or using the Service, you agree to be bound by these Terms. If you do not agree, you may not access or use the Service.

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, in which case “you” refers to that entity.

Important Notice About AI-Generated Output

SubstantiatePro produces AI-assisted regulatory analyses, substantiation gradings, suggested claim rewrites, and related outputs. These outputs are informational only. They do not constitute legal advice, regulatory advice, or a regulatory determination, and they do not establish an attorney-client or consultant-client relationship. The Service is not a substitute for review by qualified regulatory and legal counsel. See Sections 6 and 13 for full disclaimers.

1. Definitions

“Account” means the account you create to access the Service.

“Customer Content” means any data, documents, product information, claims, ingredients, study PDFs, marketing materials, or other content you upload, submit, or generate through the Service.

“Output” means any analysis, grading, dossier, suggested revision, narrative, search result, or other content generated by the Service in response to your inputs, including outputs generated using third-party artificial intelligence models.

“Subscription” means the paid plan you purchase to access the Service.

“User” means an individual authorized by you to use the Service under your Account.

2. Description of the Service

The Service provides software tools that help dietary supplement brands and related parties assess regulatory compliance, evaluate scientific substantiation for product claims, identify potential disease-claim risk, and generate substantiation dossiers. The Service uses both deterministic logic and large language model (“LLM”) technology operated by us and our third-party providers.

The Service is provided on a subscription basis with monthly usage limits described in your subscription plan. Specific feature availability, usage caps, and other plan parameters may be updated from time to time.

3. Account Registration and Eligibility

3.1 Eligibility

You must be at least 18 years of age and capable of entering into a binding contract to use the Service. The Service is intended for use by businesses, consultants, and professionals operating in the dietary supplement industry or related fields.

3.2 Account Information

You agree to provide accurate, current, and complete information during registration and to maintain that information to keep it accurate, current, and complete. You are responsible for maintaining the confidentiality of your Account credentials and for all activities under your Account.

3.3 Authorized Users

You may grant access to additional Users within your organization based on your Subscription plan. You are responsible for the conduct of each User on your Account and for ensuring each User’s compliance with these Terms.

4. Subscriptions, Fees, and Billing

4.1 Subscription Plans

Subscription plans, pricing, and included usage are described on our website at substantiatepro.com. By purchasing a Subscription, you authorize us (and our payment processor) to charge the applicable fees to your payment method on a recurring basis until cancelled.

4.2 Billing Cycle

Subscriptions are billed in advance on a recurring basis, typically monthly. Unless otherwise stated, all fees are quoted in U.S. dollars and are exclusive of applicable taxes, which are your responsibility.

4.3 Usage Limits

Subscription plans include monthly usage limits (for example, monthly limits on substantiation dossier pages, study uploads, and other AI-intensive operations). These limits are described on our website and within the Service. Usage limits reset at the beginning of each billing cycle. We may offer per-organization custom limits at our discretion.

4.4 Changes to Pricing

We may modify Subscription fees with at least 30 days’ notice prior to the change taking effect. If you do not agree to a fee change, you may cancel your Subscription before the change takes effect; continued use after the effective date constitutes acceptance of the new fees.

4.5 Refunds

Subscription fees are non-refundable except where required by applicable law or where we expressly agree in writing. Cancellation will stop future billing but does not entitle you to a refund of fees already paid for the current billing period.

4.6 Failed Payments

If we are unable to charge your payment method, we may suspend or terminate access to the Service until payment is received. You are responsible for any costs we incur in collecting unpaid fees, including reasonable attorney fees.

4.7 Auto-Renewal

Subscriptions automatically renew for successive monthly terms (or other applicable term) unless you cancel via the Service at least three (3) business days before the end of the then-current term. The cancellation will take effect at the end of the current billing period, and you will retain access to the Service for the remainder of that period.

5. Acceptable Use

You agree not to:

• Use the Service in violation of any applicable law, regulation, or third-party right.
• Upload, submit, or transmit any content that infringes intellectual property rights, violates confidentiality obligations, or contains malware or harmful code.
• Attempt to reverse engineer, decompile, scrape, or extract the source code, models, prompts, or underlying methodology of the Service, except to the extent permitted by applicable law.
• Use the Service to develop a competing product or to train AI or machine learning models.
• Resell, sublicense, or provide the Service to third parties except as expressly permitted under your Subscription.
• Circumvent or attempt to circumvent usage limits, security measures, or access controls.
• Use the Service to generate content for illegal, fraudulent, or deceptive purposes.
• Misrepresent the source, nature, or status of Output as something other than AI-assisted analysis.
• Use the Service in any manner that could damage, disable, overburden, or impair the Service or interfere with other users’ use of the Service.
• Upload or submit any clinical study, data, claim, or other content that you know or should know is false, misleading, fabricated, or materially altered from its original form.

6. Nature of the Service; AI-Assisted Output

6.1 Informational Only

Output produced by the Service is for informational purposes only. Output is not legal advice, regulatory advice, medical advice, or scientific peer review. Use of the Service does not establish an attorney-client relationship, a regulatory consultant-client relationship, or any other professional services relationship between you and Company, even where Company’s principals are licensed regulatory professionals.

6.2 No Regulatory Determination

Output produced by the Service does not constitute a determination by the U.S. Food and Drug Administration, the Federal Trade Commission, any state regulator, any retailer, or any other regulatory or commercial authority. A favorable Output (for example, a “Strong” substantiation grade) does not guarantee that a claim, product, or marketing material will be deemed compliant by any regulatory body or retailer, nor does it provide a defense in any enforcement action. An unfavorable Output does not necessarily indicate that a claim or product is non-compliant.

6.3 Not a Substitute for Counsel

You acknowledge that regulatory compliance for dietary supplements requires the exercise of professional judgment and that the Service is not a substitute for review by qualified regulatory and legal counsel. Before relying on any Output for regulatory submissions, retailer dossiers, label approvals, marketing claims, or enforcement defense, you should consult with qualified regulatory and legal counsel familiar with your specific products, jurisdictions, and circumstances.

6.4 AI Limitations

The Service uses AI models that can produce errors, omissions, outdated information, or analyses that do not accurately reflect the current state of regulatory guidance, scientific literature, or applicable law. AI models may produce different Output for the same or similar input, may miss relevant considerations, may misinterpret uploaded materials, and may generate citations or references that do not exist or are inaccurate. You are responsible for independently verifying all Output before relying on it for any decision or action.

6.5 Customer Responsibility

You bear sole responsibility for the regulatory compliance of your products, claims, labels, and marketing materials. You bear sole responsibility for the truthfulness and substantiation of your claims. You bear sole responsibility for ensuring that any reliance on Output is appropriate to your specific circumstances. Use of the Service does not transfer any portion of these responsibilities to Company.

6.6 Methodology Subject to Change

The methodology, prompts, models, scoring rubrics, and other technical components underlying the Service are subject to refinement and change. Output produced at one point in time may differ from Output produced for the same input at a later time. Company makes no representation that future Output will be consistent with prior Output.

7. Customer Content

7.1 Ownership

You retain all rights, title, and interest in Customer Content you submit to the Service. We claim no ownership of Customer Content.

7.2 License to Operate

You grant Company a non-exclusive, worldwide, royalty-free license to access, store, process, transmit, and use Customer Content solely to provide and improve the Service for you, to comply with legal obligations, and to enforce these Terms. This license terminates when Customer Content is deleted from our systems, except as necessary to comply with legal obligations or backup retention policies.

7.3 No AI Training

We do not use Customer Content to train or fine-tune any AI models, including our own and those of our third-party providers. Our third-party AI providers operate under terms that prohibit training on customer-submitted content.

7.4 Your Representations

You represent and warrant that you have all necessary rights to submit Customer Content to the Service, that Customer Content does not infringe any third-party rights, and that Customer Content does not violate any applicable law or regulation.

7.5 Confidentiality and Security

We treat Customer Content as your confidential information and maintain appropriate administrative, technical, and physical safeguards designed to protect its confidentiality, integrity, and availability in accordance with industry standards. In the event of a security incident that compromises Customer Content, we will notify you as soon as commercially practicable and in compliance with applicable law, including any obligations under the California Consumer Privacy Act and California Privacy Rights Act (“CCPA/CPRA”) and the FTC Health Breach Notification Rule. See our Privacy Policy for additional detail on how we handle Customer Content and personal information.

7.6 Personal Information and Health Data

To the extent Customer Content constitutes “personal information” under the CCPA/CPRA, “personal data” under other applicable privacy laws, or triggers the FTC Health Breach Notification Rule, our processing of that content is governed by our Privacy Policy and, where applicable, by a separate Data Processing Addendum. If you require a Data Processing Addendum for your jurisdiction or industry, contact us at legal@substantiatepro.com.

8. Intellectual Property

8.1 Company IP

The Service, including all software, models, prompts, methodology, rubrics, documentation, user interfaces, and other materials provided by Company, is owned by Company and protected by intellectual property laws. Subject to your compliance with these Terms, Company grants you a limited, non-exclusive, non-transferable, non-sublicensable license to access and use the Service for your internal business purposes during your Subscription.

8.2 Output

Subject to the limitations in these Terms (including Section 6) and to your payment of applicable fees, you may use Output for your internal business purposes, including sharing Output with retailers, regulators, manufacturers, and your professional advisors. You may not resell Output or use Output to build a competing product or service.

For clarity, you may not represent any Output as an official determination, approval, certification, or endorsement by the U.S. Food and Drug Administration, the Federal Trade Commission, or any other regulatory body, nor may you use Output in a manner that suggests Company has endorsed the regulatory compliance of your products, claims, marketing materials, or business practices. Output reflects AI-assisted analysis only; any representation to the contrary is prohibited and may result in suspension or termination of your Account.

8.3 Feedback

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

8.4 Branding

Company’s names, logos, and product names are trademarks of Company. You may not use them without our prior written consent, except as required to identify the source of Output as permitted by these Terms.

8.5 Copyright Infringement Notices (DMCA)

We respect the intellectual property rights of others and expect users to do the same. If you believe that any Customer Content, Output, or other material accessible through the Service infringes your copyright, please send a written notice to our designated copyright agent at legal@substantiatepro.com containing the information required by 17 U.S.C. § 512(c)(3), including: (a) a physical or electronic signature of the copyright owner or authorized agent; (b) identification of the copyrighted work claimed to be infringed; (c) identification of the material claimed to be infringing and information reasonably sufficient to locate it; (d) your contact information; (e) a statement of good-faith belief that use of the material is not authorized; and (f) a statement, under penalty of perjury, that the information is accurate and you are authorized to act. We will investigate properly submitted notices and, where appropriate, remove or disable access to the allegedly infringing material in accordance with the Digital Millennium Copyright Act.

Repeat infringers may have their Accounts terminated in Company’s sole discretion in appropriate circumstances.

9. Confidentiality

Each party may disclose information that is non-public, proprietary, or confidential (“Confidential Information”) to the other party. The receiving party will protect Confidential Information using at least the same degree of care it uses for its own confidential information of similar sensitivity, and in no event less than a reasonable degree of care. Confidential Information may be used only to perform under or exercise rights under these Terms. Customer Content is the Confidential Information of the Customer.

10. Term and Termination

10.1 Term

These Terms remain in effect while your Account is active. Your Subscription will automatically renew for successive monthly terms (or other applicable term) in accordance with Section 4.7 unless cancelled.

10.2 Cancellation by You

You may cancel your Subscription at any time through the Service or by contacting us. Cancellation takes effect at the end of the then-current billing period.

10.3 Termination by Company

We may suspend or terminate your access to the Service immediately if you breach these Terms, fail to pay fees when due, use the Service in a manner that risks harm to Company or other users, or as otherwise required by law. We may also terminate the Service or your access to it on at least 30 days’ prior written notice, in which case we will refund any prepaid fees for the unused portion of your Subscription.

10.4 Effect of Termination

Upon termination, your right to access the Service ends. You will have a reasonable period (as described in our Privacy Policy) to export Customer Content before it is deleted. Sections that by their nature should survive termination (including Sections 6, 7, 8, 9, 11, 12, 13, 14, and 16) will survive.

11. Disclaimer of Warranties

THE SERVICE AND ALL OUTPUT ARE PROVIDED ON AN “AS IS” AND “AS AVAILABLE” BASIS, WITHOUT WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED. COMPANY EXPRESSLY DISCLAIMS ALL WARRANTIES, INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT, ACCURACY, COMPLETENESS, TIMELINESS, AND TITLE.

WITHOUT LIMITING THE FOREGOING, COMPANY DOES NOT WARRANT THAT THE SERVICE WILL BE UNINTERRUPTED, ERROR-FREE, OR SECURE; THAT OUTPUT WILL BE ACCURATE, RELIABLE, OR FREE OF ERRORS; THAT OUTPUT WILL REFLECT THE CURRENT STATE OF REGULATORY GUIDANCE, SCIENTIFIC LITERATURE, OR APPLICABLE LAW; OR THAT USE OF THE SERVICE OR RELIANCE ON OUTPUT WILL RESULT IN REGULATORY COMPLIANCE, FAVORABLE REGULATORY OUTCOMES, OR ACCEPTANCE BY RETAILERS, REGULATORS, OR ANY OTHER PARTY.

Some jurisdictions do not allow the exclusion of implied warranties, so some of these exclusions may not apply to you. In such cases, the implied warranties are limited to the minimum scope and duration required by law.

12. Limitation of Liability

TO THE MAXIMUM EXTENT PERMITTED BY LAW, IN NO EVENT WILL COMPANY OR ITS OFFICERS, DIRECTORS, EMPLOYEES, AGENTS, OR LICENSORS BE LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, EXEMPLARY, OR PUNITIVE DAMAGES, INCLUDING LOST PROFITS, LOST REVENUE, LOST DATA, BUSINESS INTERRUPTION, REGULATORY ENFORCEMENT EXPENSES, OR LOSS OF GOODWILL, ARISING OUT OF OR RELATED TO YOUR USE OF OR INABILITY TO USE THE SERVICE OR ANY OUTPUT, EVEN IF COMPANY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

TO THE MAXIMUM EXTENT PERMITTED BY LAW, COMPANY’S TOTAL AGGREGATE LIABILITY ARISING OUT OF OR RELATED TO THESE TERMS OR YOUR USE OF THE SERVICE WILL NOT EXCEED THE GREATER OF (A) THE TOTAL FEES PAID BY YOU TO COMPANY DURING THE 12 MONTHS PRECEDING THE EVENT GIVING RISE TO THE CLAIM, OR (B) ONE HUNDRED U.S. DOLLARS ($100).

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

13. Indemnification

You agree to indemnify, defend, and hold harmless Company and its officers, directors, employees, and agents from and against any claims, liabilities, damages, losses, and expenses (including reasonable attorney fees) arising out of or related to: (a) your use of the Service; (b) Customer Content you submit; (c) your products, claims, labels, or marketing materials; (d) your violation of these Terms; (e) your violation of applicable law; or (f) your infringement of any third-party right.

14. Governing Law and Dispute Resolution

14.1 Governing Law

These Terms are governed by the laws of the State of Delaware, without regard to its conflict of laws principles. The United Nations Convention on Contracts for the International Sale of Goods does not apply.

14.2 Venue for Excluded Claims

Subject to Section 14.3 (Binding Arbitration), any dispute, claim, or controversy not subject to arbitration will be brought exclusively in the state or federal courts located in New Castle County, Delaware, and you consent to the personal jurisdiction of those courts. Notwithstanding the arbitration requirement, either party may seek injunctive or other equitable relief from a court of competent jurisdiction for actual or threatened infringement of intellectual property rights, breach of confidentiality, or to prevent imminent harm.

14.3 Binding Arbitration

PLEASE READ THIS SECTION CAREFULLY. IT REQUIRES YOU TO RESOLVE DISPUTES THROUGH BINDING INDIVIDUAL ARBITRATION AND WAIVES YOUR RIGHT TO PARTICIPATE IN A CLASS ACTION.

Any dispute, claim, or controversy arising out of or relating to these Terms, the Service, or any Output (a “Dispute”) that is not resolved through informal good-faith negotiation between the parties within thirty (30) days will be resolved exclusively by binding individual arbitration administered by JAMS in accordance with its Streamlined Arbitration Rules and Procedures (for Disputes seeking less than $250,000 in damages) or its Comprehensive Arbitration Rules and Procedures (for Disputes seeking $250,000 or more), as in effect at the time arbitration is commenced. The arbitration will be conducted by a single arbitrator in Wilmington, Delaware (or by video conference if both parties agree), and the arbitrator’s award will be final and binding and may be entered as a judgment in any court of competent jurisdiction.

CLASS ACTION WAIVER. YOU AND COMPANY AGREE THAT EACH PARTY MAY BRING CLAIMS AGAINST THE OTHER ONLY IN AN INDIVIDUAL CAPACITY, AND NOT AS A PLAINTIFF OR CLASS MEMBER IN ANY PURPORTED CLASS, COLLECTIVE, CONSOLIDATED, OR REPRESENTATIVE PROCEEDING. The arbitrator may not consolidate the claims of multiple parties or preside over any form of representative or class proceeding. If this waiver is found to be unenforceable for any reason with respect to a particular Dispute, that Dispute will be severed from arbitration and brought in the courts specified in Section 14.2, but the remainder of this Section 14.3 will remain in effect for all other Disputes.

The party initiating arbitration is responsible for the filing fee in accordance with the applicable JAMS rules. Each party will bear its own attorney fees and costs, except that the arbitrator may award attorney fees and costs to the prevailing party where (a) the Dispute is determined to have been brought frivolously, in bad faith, or for an improper purpose, or (b) such award is otherwise permitted by applicable law or these Terms.

Exceptions to arbitration: This Section 14.3 does not apply to (i) any action to compel arbitration, confirm an arbitration award, or seek to vacate an arbitration award, or (ii) requests for injunctive or other equitable relief as described in Section 14.2.

14.4 Time Limitation

Any claim arising out of or related to these Terms or the Service must be filed within one (1) year after the date the claim accrued or, if later, the shortest period permitted by applicable law. Claims filed after this period are permanently barred.

15. Modifications to the Service and Terms

We may modify the Service at any time, including by adding, removing, or changing features. We will provide reasonable notice of material changes.

We may modify these Terms by posting an updated version and notifying you by email or through the Service. Material changes take effect 30 days after notice (or sooner if required by law). Continued use of the Service after the effective date constitutes acceptance of the modified Terms. If you do not accept the modified Terms, you must stop using the Service before the effective date.

16. General Provisions

16.1 Entire Agreement

These Terms, together with the Privacy Policy and any order forms or supplemental terms we provide, constitute the entire agreement between you and Company regarding the Service and supersede any prior agreements.

16.2 No Waiver

Our failure to enforce any provision of these Terms is not a waiver of that provision or any other provision.

16.3 Severability

If any provision of these Terms is held to be unenforceable, the remaining provisions will continue in full force and effect.

16.4 Assignment

You may not assign or transfer these Terms or your Account without our prior written consent. We may assign these Terms in connection with a merger, acquisition, financing, or sale of assets.

16.5 Notices

Notices to you will be sent to the email address associated with your Account. Notices to Company should be sent to legal@substantiatepro.com with a copy to Friese Regulatory LLC at 8 The Green, Ste B, Dover, DE 19901.

16.6 Force Majeure

Neither party will be liable for any failure or delay in performance due to causes beyond its reasonable control, including acts of God, natural disasters, war, terrorism, labor disputes, governmental actions, internet or telecommunications failures, or third-party service provider outages.

16.7 Independent Contractors

You and Company are independent contractors. These Terms do not create any partnership, joint venture, employment, or agency relationship.

16.8 Headings

Section headings are for convenience only and have no legal effect.

17. Contact

Questions about these Terms? Contact us at:

Friese Regulatory LLC
Attn: Legal
8 The Green, Ste B, Dover, DE 19901
legal@substantiatepro.com