FDA Intel
by Onix AI LLC

Terms of Service — FDA Intel

Effective date: June 10, 2026 Onix AI LLC

These Terms of Service ("Terms") govern your access to and use of FDA Intel, a litigation-intelligence software service operated at https://fda.onix.bot (the "Service" or "Platform") by Onix AI LLC, a Florida limited liability company with its principal place of business at 7901 4th Street North, STE 300, St. Petersburg, FL 33702 ("Onix," "we," "us," or "our").

The Service is provided only to plaintiff-side law firms and their authorized personnel for professional use. By accessing or using the Service, you agree to these Terms on behalf of yourself and the law firm you represent. If you do not agree, do not access or use the Service.

READ THIS FIRST. FDA Intel is an information and research tool. Its outputs are signals and data, not legal advice and not a case evaluation. Using FDA Intel does not create an attorney-client relationship with Onix. AI-generated and data-derived outputs can be wrong, incomplete, or out of date. You are solely responsible for independently verifying every output and for all of your own professional and ethical obligations. Any reliance on the Service without independent verification by a licensed attorney is unreasonable and is at your sole risk. See Section 3.

Note on these Terms. These Terms are a protective template prepared by the owner of Onix AI LLC and are intended to be reviewed by a licensed Florida attorney before use. They are not themselves legal advice to you.

1. Acceptance, Eligibility, and Authority

1.1 Agreement to These Terms. By creating an account, accessing, or using the Service, you acknowledge that you have read, understood, and agree to be bound by these Terms, by our Privacy Policy, and by any in-product disclaimers and notices that we present in connection with the Service (collectively, the "Disclaimers"), each of which is incorporated into these Terms by reference and forms part of your agreement with Onix.

1.2 Business / Professional Use Only. The Service is a business-to-business ("B2B") tool intended exclusively for licensed law firms and their authorized lawyers and staff. The Service is not a consumer product, is not directed to consumers, and is not intended for personal, family, or household use. It is not directed to and may not be used by anyone under the age of eighteen (18). You may not use the Service as, or hold it out to any third party as, a consumer-facing legal service.

1.3 Authority to Bind the Firm. If you access the Service on behalf of a law firm or other organization (the "Firm," and together with its authorized users, "you"), you represent and warrant that you are authorized to accept these Terms on the Firm's behalf and to bind the Firm to them. "You" includes both the individual user and the Firm, which are jointly and severally responsible for compliance with these Terms.

1.4 Relationship to the MSA / SOW. Where the Firm has also entered into a Master Services Agreement and/or Statement of Work with Onix (collectively, the "MSA"), these Terms supplement the MSA and apply to all access to and use of the Service. In the event of a direct conflict between these Terms and a signed MSA, the signed MSA controls as to the matters expressly addressed in it (including fees, service levels, confidentiality, data handling, and any negotiated liability terms).

1.5 Eligibility Representations. You represent and warrant that (a) you and each of your authorized users are members of, or personnel of, a law firm engaged in lawful legal practice; (b) all registration information you provide is accurate and kept current; and (c) your use of the Service will comply with all laws and with the rules of professional conduct applicable to you.

2. Description of the Service

2.1 What FDA Intel Does. FDA Intel aggregates and organizes information drawn from third-party public data sources — including, without limitation, U.S. Food and Drug Administration (FDA) databases (such as FAERS and MAUDE), federal court dockets accessed via CourtListener / PACER, recall feeds (FDA, CPSC, NHTSA), U.S. Securities and Exchange Commission (SEC) filings, clinical-trial registries, and news sources — and applies artificial-intelligence tools (provided by Anthropic) to:

2.2 What FDA Intel Is Not. The Service is a research, monitoring, and drafting-assistance tool. It does not practice law, does not evaluate the merits of any potential claim or case, does not make filing or case-selection decisions, and does not replace the independent professional judgment of a licensed attorney. Scores and rankings reflect data patterns and model outputs — not legal conclusions about liability, causation, value, or viability.

2.3 Onix Is Not Engaged in the Practice of Law. Onix is a technology provider. Onix's development, hosting, and provision of the Service and its software does not constitute the practice of law and is not the rendering of legal services or legal advice to you, your Firm, or any client. You are solely responsible for ensuring that your use of the Service — including any use of AI-generated drafts or other outputs — complies with all rules governing the practice of law and the unauthorized practice of law, and does not cause you, your Firm, or Onix to engage in the unauthorized practice of law.

2.4 Changes to the Service. We may add, modify, suspend, or discontinue features of the Service at any time. We will use commercially reasonable efforts to avoid material degradation of core functionality for active subscribers; specific service-level commitments, if any, are governed by the MSA.

3. NOT LEGAL ADVICE · NO ATTORNEY-CLIENT RELATIONSHIP · NO CASE EVALUATION

This Section is fundamental to your use of the Service. Read it carefully.

3.1 NOT LEGAL ADVICE. All outputs of the Service — including scores, rankings, ranked lists, alerts, dossiers, summaries, AI-generated drafts, complaint shells, and any other content — are provided for informational and research purposes only. They are NOT legal advice, NOT a legal opinion, and NOT a recommendation to take or refrain from any legal action. They are signals and information to be evaluated by a licensed attorney exercising independent professional judgment.

3.2 NO ATTORNEY-CLIENT RELATIONSHIP. Onix is a technology provider, not a law firm. No attorney-client relationship is or will be created between you and Onix by your use of the Service, by these Terms, or by any output the Service produces. Onix does not represent you, your Firm, or any client of your Firm, and owes you no fiduciary, advisory, or professional duty of a lawyer. Onix does not and cannot supervise, direct, or take responsibility for the practice of law.

3.3 NO CASE EVALUATION. The Service does not evaluate, qualify, value, or vet any potential case, claim, claimant, or client. Litigation-potential scores, "MDL" or mass-tort signals, and similar outputs are statistical and heuristic indicators only. They are not a determination that a viable claim exists, that a statute of limitations is open, that causation can be proven, or that any matter is worth pursuing. Decisions about case selection, intake, retention, filing, and strategy are yours alone.

3.4 AI and Data Can Be Wrong. You expressly acknowledge and agree that:

3.5 Mandatory Attorney Review of Drafts. Any AI-generated draft — including every complaint shell, pleading, or other drafting output — is an unreviewed first draft only. It MUST be independently reviewed, verified, corrected, and approved by a licensed attorney before it is filed, served, sent, or relied upon for any purpose. Onix is not responsible for any draft used without such review. The Service does not check jurisdictional requirements, local rules, deadlines, signature/verification requirements, Rule 11 obligations, or factual accuracy, and does not determine whether any draft is non-frivolous, well-grounded in fact, or warranted by existing law.

3.6 Your Sole Responsibility. You are solely responsible for independently verifying the accuracy, completeness, currency, and applicability of every output before relying on it, and for all professional and ethical obligations arising from your use of the Service. You acknowledge and agree that any reliance on any output without such independent verification by a licensed attorney is unreasonable and is at your sole risk, and you assume all risk of any decision or action taken in reliance on the Service.

4. Your Responsibilities

By using the Service, you agree that you will:

4.1 Verify Everything. Independently verify all outputs — data, citations, scores, summaries, and drafts — against primary sources before relying on them in any legal matter, client communication, court filing, or business decision.

4.2 Have Attorneys Review AI Drafts. Ensure that every AI-generated draft is reviewed, corrected, and approved by a licensed attorney before any use, as required by Section 3.5.

4.3 Comply with Professional and Ethical Rules. Comply with all applicable rules of professional conduct and bar-association requirements, including duties of competence (including technological competence), diligence, candor to the tribunal, confidentiality, supervision of non-lawyer assistance and of AI tools, the rules governing the unauthorized practice of law, and rules governing advertising, solicitation, and client intake. You remain fully responsible for your own professional judgment and conduct. Onix makes no representation that any output complies with any bar rule or court requirement.

4.4 Comply with Law. Use the Service only for lawful purposes and in compliance with all applicable federal, state, and local laws and regulations.

4.5 Maintain Account Security. Keep your login credentials confidential, restrict access to authorized personnel of your Firm, use reasonable security practices, and promptly notify us at p@s.cr of any suspected unauthorized access or use. You are responsible for all activity occurring under your accounts. You must not share accounts with anyone outside your Firm.

4.6 Provide Accurate Information. Provide and maintain accurate account, user, and configuration information.

4.7 Be Responsible for Your Users and Your Data. Ensure that all of your authorized users comply with these Terms, and be responsible for the content, files, queries, watches, and other materials you submit to the Service ("Your Content"), including that you have the right to submit them.

5. Acceptable Use and Prohibited Conduct

5.1 Acceptable Use. You may access and use the Service only for your Firm's internal, professional litigation-research and practice purposes, in accordance with these Terms and the license granted in Section 6.

5.2 Prohibited Conduct. You will not, and will not permit any user or third party to:

5.3 Enforcement. We may investigate suspected violations and may suspend or terminate access for conduct we reasonably believe violates this Section, as set out in Section 12.

6. Intellectual Property and License

6.1 Onix Owns the Platform. As between the parties, Onix and its licensors own and retain all right, title, and interest in and to the Service and Platform, including all software, source code, models, scoring methodologies, prompts, user interfaces, designs, documentation, and all related intellectual property and any improvements thereto (collectively, "Onix IP"). Except for the limited license in Section 6.3, no rights in the Onix IP are granted to you, whether by implication, estoppel, or otherwise.

6.2 You Own Your Content. As between the parties, you own Your Content — the chat inputs, uploaded files, watches/watchlists, configurations, and other materials you submit to the Service. You grant Onix a limited, non-exclusive, worldwide license to host, store, process, transmit, and display Your Content solely to provide and support the Service to you (including transmitting it to the AI provider to generate responses), and as otherwise permitted by the Privacy Policy and the MSA. Onix will not use Your Content to train, fine-tune, or improve any AI model.

6.3 License to You. Subject to your compliance with these Terms and payment of all applicable fees, Onix grants you a limited, non-exclusive, non-transferable, non-sublicensable, revocable license to access and use the Service, and to use the outputs generated for you, for your Firm's internal professional legal-services purposes during the term of your subscription. You may use, adapt, and incorporate outputs into your own legal work product, subject to Sections 3 through 5.

6.4 Feedback. If you provide suggestions or feedback about the Service, Onix may use it freely and without obligation or compensation to you.

7. Third-Party Data Sources

7.1 Sources Outside Our Control. The Service aggregates information from third-party public data sources that Onix does not own or control (see Section 2.1). Onix does not generate the underlying data and is not responsible for its content.

7.2 No Guarantee of Accuracy or Timeliness. Onix does not guarantee the accuracy, completeness, reliability, currency, or availability of any third-party data. Such data may be inaccurate, incomplete, out of date, delayed, miscategorized, removed, or otherwise unreliable, and third-party sources may change, restrict, or discontinue access at any time without notice. You are responsible for verifying all such data against primary, authoritative sources.

7.3 Source Terms. Your use of the Service does not grant you any rights in third-party data beyond what the applicable source's terms permit, and you must comply with those terms (see Section 5.2(f)).

8. AI-Generated Output

8.1 Nature of AI Output. Portions of the Service rely on third-party large-language-model technology. AI-generated output is probabilistic, not authoritative. It may be inaccurate, incomplete, biased, internally inconsistent, or outdated; may include fabricated facts, quotations, or legal citations; and may not reflect current law or facts.

8.2 No Reliance Without Verification. You must not rely on any AI-generated output without independent verification by a qualified human, and must not file, serve, or act on any AI-generated draft without the attorney review required by Section 3.5.

8.3 No Warranty as to Output. Onix makes no representation or warranty that any AI-generated output is accurate, complete, fit for any particular purpose, non-infringing, or suitable for use in any legal matter, including that any draft is non-frivolous, well-grounded in fact, or warranted by existing law.

9. DISCLAIMER OF WARRANTIES

9.1 AS IS. TO THE MAXIMUM EXTENT PERMITTED BY LAW, THE SERVICE, THE PLATFORM, AND ALL OUTPUTS AND DATA ARE PROVIDED "AS IS" AND "AS AVAILABLE," WITH ALL FAULTS AND WITHOUT WARRANTY OF ANY KIND.

9.2 NO IMPLIED WARRANTIES. ONIX AND ITS LICENSORS AND SUPPLIERS EXPRESSLY DISCLAIM ALL WARRANTIES, WHETHER EXPRESS, IMPLIED, STATUTORY, OR OTHERWISE, INCLUDING WITHOUT LIMITATION ALL IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE, AND NON-INFRINGEMENT, AND ANY WARRANTIES ARISING FROM COURSE OF DEALING, USAGE, OR TRADE PRACTICE.

9.3 NO WARRANTY OF RESULTS. ONIX DOES NOT WARRANT THAT THE SERVICE WILL BE UNINTERRUPTED, TIMELY, SECURE, OR ERROR-FREE; THAT DEFECTS WILL BE CORRECTED; THAT THE SERVICE OR ANY OUTPUT WILL BE ACCURATE, COMPLETE, CURRENT, RELIABLE, OR SUITABLE FOR ANY PURPOSE; OR THAT THE SERVICE WILL MEET YOUR REQUIREMENTS OR PRODUCE ANY PARTICULAR LEGAL OR BUSINESS RESULT. NO ADVICE OR INFORMATION OBTAINED FROM THE SERVICE CREATES ANY WARRANTY NOT EXPRESSLY STATED IN THESE TERMS.

9.4 Allocation of Risk. YOU ACKNOWLEDGE THAT THIS DISCLAIMER IS A MATERIAL BASIS OF THE BARGAIN AND THAT ONIX WOULD NOT PROVIDE THE SERVICE WITHOUT IT. Some jurisdictions do not allow the exclusion of certain warranties; in such cases, the foregoing exclusions apply to the fullest extent permitted by law.

10. LIMITATION OF LIABILITY

10.1 No Indirect Damages. TO THE MAXIMUM EXTENT PERMITTED BY LAW, IN NO EVENT WILL ONIX OR ITS OFFICERS, MEMBERS, EMPLOYEES, CONTRACTORS, OR LICENSORS BE LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, EXEMPLARY, OR PUNITIVE DAMAGES, OR FOR ANY LOST PROFITS, LOST REVENUE, LOST BUSINESS, LOST OR INACCURATE DATA, LOSS OF GOODWILL, LOST CASES OR CLIENTS, MISSED DEADLINES, SANCTIONS, OR PROFESSIONAL-LIABILITY EXPOSURE, ARISING OUT OF OR RELATED TO THE SERVICE OR THESE TERMS, REGARDLESS OF THE THEORY OF LIABILITY (CONTRACT, TORT, NEGLIGENCE, STRICT LIABILITY, OR OTHERWISE) AND EVEN IF ONIX HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

10.2 Liability Cap. TO THE MAXIMUM EXTENT PERMITTED BY LAW, ONIX'S TOTAL CUMULATIVE LIABILITY ARISING OUT OF OR RELATED TO THE SERVICE OR THESE TERMS WILL NOT EXCEED THE TOTAL FEES ACTUALLY PAID BY THE FIRM TO ONIX FOR THE SERVICE DURING THE TWELVE (12) MONTHS IMMEDIATELY PRECEDING THE EVENT GIVING RISE TO THE CLAIM. IF NO FEES WERE PAID DURING THAT PERIOD, ONIX'S TOTAL LIABILITY WILL NOT EXCEED ONE HUNDRED U.S. DOLLARS (US $100). FEES PAID UNDER A SIGNED MSA ARE SUBJECT TO THE LIABILITY CAP IN THAT MSA, NOT THIS SECTION, AS PROVIDED IN SECTION 10.4.

10.3 Essential Basis; Application. THE LIMITATIONS IN THIS SECTION ARE AN ESSENTIAL ELEMENT OF THE BARGAIN, APPLY EVEN IF ANY LIMITED REMEDY FAILS OF ITS ESSENTIAL PURPOSE, AND APPLY IN THE AGGREGATE TO ALL CLAIMS AND ALL USERS OF THE FIRM. Some jurisdictions do not allow certain limitations; in such cases, liability is limited to the fullest extent permitted by law.

10.4 Relationship to MSA. Where a signed MSA contains a limitation-of-liability provision, that provision governs claims within its scope; this Section governs all other claims arising from use of the Service.

11. Release of First-Party Claims and Indemnification

11.1 Release of First-Party Claims. To the maximum extent permitted by law, you and your Firm release, waive, and forever discharge the Onix Parties (as defined in Section 11.2) from any and all claims, demands, losses, damages, liabilities, costs, and expenses — including any malpractice, sanctions, lost-case, lost-client, missed-deadline, or professional-liability loss — that you or your Firm incur arising out of or relating to your or your users' use of, or reliance on, the Service or any output. You agree that any such losses are your sole responsibility, and that this release applies regardless of the theory of liability and in addition to (and without limiting) the disclaimers in Section 9 and the limitations in Section 10. This Section 11.1 does not enlarge any right you may have under a signed MSA, and where a signed MSA addresses the same subject matter, the MSA controls within its scope.

11.2 Your Indemnity. You will defend, indemnify, and hold harmless Onix and its officers, members, employees, contractors, and licensors (the "Onix Parties") from and against any and all third-party claims, demands, suits, proceedings, and resulting losses, damages, liabilities, costs, and expenses (including reasonable attorneys' fees) arising out of or related to:

11.3 Procedure. Onix will provide you with prompt notice of any claim subject to indemnification (provided that failure to do so will not relieve you except to the extent prejudiced), and reasonable cooperation at your expense. Onix may, at its option, assume the exclusive defense and control of any matter subject to indemnification by you, in which case you will cooperate as reasonably requested and will pay the Onix Parties' reasonable costs and attorneys' fees. You may not settle any claim in a manner that imposes any obligation or admission on an Onix Party without that party's prior written consent.

12. Suspension and Termination

12.1 Suspension. We may suspend or restrict your access to the Service, in whole or in part, immediately and without liability, if we reasonably believe that (a) you have violated these Terms (including Section 5); (b) your use poses a security, legal, or operational risk to the Service or others; or (c) suspension is required to comply with law or third-party source terms. We will use reasonable efforts to notify you where practicable.

12.2 Termination. Termination rights, notice periods, and the effects of termination for subscribing Firms are governed by the MSA. For any access not covered by an MSA, either party may terminate at any time; we may terminate or suspend access for non-payment, violation of these Terms, or discontinuation of the Service.

12.3 Effect of Termination. Upon termination, your license to use the Service ends and you must stop using it. Data export and deletion are handled as described in the Privacy Policy and the MSA. Sections that by their nature should survive — including Sections 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 13, 14, and 15 — survive termination.

13. Fees and Billing

13.1 Governed by the MSA. Fees, invoicing, payment terms, pass-through AI/LLM usage charges, taxes, and refunds are governed by the MSA and applicable Statement of Work, not by these Terms. Nothing in these Terms modifies those commercial terms.

13.2 Non-Payment. Without limiting the MSA, we may suspend access to the Service for undisputed amounts that remain overdue, consistent with the MSA's payment and suspension provisions.

14. Confidentiality and Privacy

14.1 Confidentiality. The handling of confidential information, including Your Content and any privileged or work-product materials, is governed by the confidentiality provisions of the MSA. Where no MSA applies, each party will protect the other's non-public information with reasonable care and use it only to perform under these Terms.

14.2 Privacy. Our collection and use of personal and account information is described in our Privacy Policy, incorporated by reference. In summary, and as further described there: we use only essential session cookies (no third-party advertising trackers); data is stored encrypted with nightly off-site backups; Your Content is processed to provide the Service and is sent to Anthropic's API to generate responses but is not used to train any AI model; our standard sub-processors are our hosting provider (Render), AWS S3 (backups), Anthropic (AI), and Resend (transactional email); and you may export and request deletion of your data. We maintain reasonable security but cannot guarantee absolute security. This is a B2B service for law firms and is not directed to consumers or children. The Privacy Policy describes our practices and does not create any warranty beyond those (if any) expressly stated in these Terms or a signed MSA; the disclaimers in Section 9 and the limitations of liability in Section 10 apply to any claim relating to the Privacy Policy.

15. General Provisions

15.1 Governing Law. These Terms are governed by the laws of the State of Florida, without regard to its conflict-of-laws rules. The United Nations Convention on Contracts for the International Sale of Goods does not apply.

15.2 Venue; Jury and Class-Action Waivers; Dispute Resolution. The parties will first attempt in good faith to resolve any dispute informally by contacting p@s.cr. Any dispute, claim, or controversy arising out of or relating to the Service or these Terms that is not resolved informally will be brought exclusively in the state or federal courts located in Pinellas County, Florida, and each party irrevocably consents to the personal jurisdiction and venue of those courts and waives any objection based on inconvenient forum. EACH PARTY KNOWINGLY, VOLUNTARILY, AND INTENTIONALLY WAIVES ANY RIGHT TO A JURY TRIAL in any such proceeding. TO THE MAXIMUM EXTENT PERMITTED BY LAW, EACH PARTY WAIVES ANY RIGHT TO BRING OR PARTICIPATE IN ANY CLASS, COLLECTIVE, CONSOLIDATED, OR REPRESENTATIVE ACTION arising out of or relating to the Service or these Terms, and any claim will be brought only in that party's individual capacity. Where a signed MSA contains a dispute-resolution provision, that provision controls for matters within its scope.

15.3 Limitation Period. TO THE MAXIMUM EXTENT PERMITTED BY LAW, ANY CLAIM ARISING OUT OF OR RELATED TO THE SERVICE OR THESE TERMS MUST BE FILED WITHIN ONE (1) YEAR AFTER THE CLAIM ACCRUES, OR IT IS PERMANENTLY BARRED, EXCEPT WHERE A LONGER PERIOD IS REQUIRED BY APPLICABLE LAW.

15.4 Changes to These Terms. We may modify these Terms from time to time. If we make material changes, we will provide reasonable notice (for example, by email to your account contact or by posting the updated Terms with a new effective date at https://fda.onix.bot). Changes take effect on the stated effective date, and your continued use of the Service after that date constitutes acceptance of the updated Terms. If you do not agree to a change, you must stop using the Service. Where a signed MSA applies, changes to these Terms will not override the negotiated terms of that MSA.

15.5 Severability. If any provision of these Terms is held invalid or unenforceable, that provision will be modified to the minimum extent necessary to make it enforceable, or if it cannot be, severed, and the remaining provisions will remain in full force and effect.

15.6 Entire Agreement. These Terms, together with the Privacy Policy, the Disclaimers, and any applicable MSA, constitute the entire agreement between you and Onix regarding the Service and supersede all prior or contemporaneous agreements and understandings on that subject. As stated in Section 1.4, a signed MSA controls over these Terms to the extent of any conflict.

15.7 Assignment. You may not assign or transfer these Terms or any rights under them without Onix's prior written consent, and any attempt to do so is void. Onix may assign these Terms in connection with a merger, acquisition, reorganization, or sale of all or substantially all of its assets. These Terms bind and benefit the parties' permitted successors and assigns.

15.8 No Waiver. No failure or delay by Onix in exercising any right will waive it, and no waiver is effective unless in writing.

15.9 Relationship of the Parties. The parties are independent contractors. These Terms do not create any partnership, joint venture, agency, fiduciary, employment, or — as stated in Section 3.2 — attorney-client relationship.

15.10 Force Majeure. Onix is not liable for any delay or failure to perform (other than your payment obligations) caused by events beyond its reasonable control, including acts of God, natural disasters, war, terrorism, civil unrest, pandemics, government action, network or power failures, or failures or changes of third-party services or data sources.

15.11 Notices. Notices to Onix must be sent to p@s.cr. We may give notice to you via the email associated with your account or by posting within the Service. Where an MSA specifies notice addresses, those apply to matters under the MSA.

15.12 Headings; Interpretation. Section headings are for convenience only and do not affect interpretation. "Including" means "including without limitation."

16. Contact

Questions about these Terms or the Service may be directed to:

Onix AI LLC 7901 4th Street North, STE 300 St. Petersburg, FL 33702 Email: p@s.cr

FDA Intel is a research and information tool provided by Onix AI LLC. It is not a law firm, does not provide legal advice, and does not create an attorney-client relationship. All outputs require independent verification and licensed-attorney review before any use.

© 2026 Onix AI LLC · 7901 4th Street North, STE 300, St. Petersburg, FL 33702 · p@s.cr