Terms of Service

2.Key words

• Documents means the files we make available to buy or claim through the Service, such as FDA Form 483s, establishment inspection reports, warning letters, close-out letters, firms' responses and similar records, in any format.
• Site Content means everything else on the Service: firm, site, investigator and regulation profiles, summaries, descriptions, metadata, data, statistics, charts, search results, text, design and software.
• Your Organization means the single company, firm, agency, university or other organization for which you buy a Document. If you buy as an individual with no organization, Your Organization is you alone.
• Authorized Users means you and the employees and individual contractors of Your Organization who work for Your Organization under a duty of confidentiality.

3.Who may use FDA Intel

The Service is intended for professional and business use. You must be at least 18 years old and able to form a binding contract.

You may not use the Service if you are barred from doing so under the laws that apply to you, including the sanctions laws described in section 23, or if we have previously suspended or closed your account.

4.Accounts

Some features, including downloads, need an account. You may sign in with an emailed one-time code or with Google. Give us accurate information and keep it up to date.

One account is for one person. Do not share your sign-in, let others use your account, or create accounts for other people without their permission. You are responsible for everything done through your account and for keeping access to your email secure. Tell us at info@fdaintel.ai right away if you think someone else has used your account.

We may refuse to open an account, ask you to verify your email or identity, or limit an account where we reasonably suspect abuse, fraud or a breach of these Terms.

5.Your first document is on us

From time to time we may offer a new, verified account one Document at no charge. The offer is limited to one per person and one per organization, whatever the number of accounts or email addresses. We decide which Documents qualify and may change or end the offer at any time.

A Document you receive under this offer is covered by the same licence and rules as a Document you pay for (section 7).

If we reasonably believe someone has used multiple accounts, disposable or shared email addresses, or other tricks to get more than one Document this way, we may cancel the extra Documents, charge the price shown on the Service for them, and suspend or close the accounts involved.

6.Buying documents

6.1Our payment provider is the seller of record

Every purchase on FDA Intel is processed by our payment provider, which acts as our online reseller and Merchant of Record. That means our payment provider sells the purchase to you, charges your payment method, calculates and collects any sales tax or VAT, issues your invoice, and handles payment questions, including refunds it processes for us. Your payment is also subject to our payment provider's own buyer terms and privacy notice, which are shown at checkout.

These Terms govern your account, your use of the Service, and the licence to use the Documents you buy. The terms of our payment provider govern the payment itself. Nothing in these Terms limits any right you have against your card issuer or under card-network rules.

6.2Prices, orders and delivery

The price you pay is the price shown at checkout, plus any tax our payment provider adds there. Prices and any discounts may change at any time, but a change does not affect an order you have already paid for.

An order is accepted when payment is confirmed. We may refuse or cancel an order before or after payment if a Document was listed in error, the price was clearly wrong, the order looks fraudulent, or the purchase would breach these Terms or the law. If we cancel a paid order, you will get a refund through our payment provider.

Documents are delivered digitally. After payment you can download your Documents from your receipt and from your account, within the download allowance and time window shown at checkout or on your receipt. Please keep your own copy: we do not promise that any Document will stay available for download forever.

At checkout you ask us to give you access to your download right away. Because the Document is digital content supplied immediately, you lose any legal right to cancel and get your money back once the download is available to you, to the extent the law allows. Our Refund Policy explains when we will still put things right.

6.3Plans and team licences

If we offer subscriptions, credits, team licences or other plans, the extra terms shown when you sign up for them also apply. If you need to share Documents more widely than section 7 allows, contact us at info@fdaintel.ai about a wider licence.

7.Your licence to use documents

7.1What you get

When you buy or claim a Document, and as long as you keep to these Terms, we grant you a limited, non-exclusive, non-transferable, non-sublicensable licence to download that Document and to use it for the internal business purposes of Your Organization, by its Authorized Users only. The licence does not expire, but we may end it if you breach these Terms (section 18). You buy a licence, not the Document itself or any rights in it.

One purchase covers one organization. A second organization, including a client, a parent company or an affiliate that is a separate legal entity, needs its own purchase or a written licence from us.

7.2What you may do

• Read, store and print the Document, and keep copies on systems that only Your Organization's Authorized Users can reach.
• Use the Document in Your Organization's own work, such as inspection readiness, quality and compliance programs, supplier and due-diligence reviews, training and internal reports.
• Quote short passages in Your Organization's internal reports and presentations, with a reference to FDA Intel.
• Submit the Document, or extracts of it, as an exhibit or evidence in Your Organization's own legal, arbitration or regulatory proceedings, to the extent needed for those proceedings, and in Your Organization's own communications with the U.S. Food and Drug Administration or another regulator.
• Share the Document in confidence with Your Organization's lawyers, auditors and insurers, solely so that they can advise Your Organization.

7.3Consultants and advisers

If you are a consultant, lawyer, auditor or other adviser, you may read a Document you bought and use what it says to advise your own clients, including by describing its contents, giving your analysis and quoting short passages in your advice or reports.

You may not give a client the Document file itself, a copy of it, or a substantial part of it, unless that client buys the Document from FDA Intel itself or you have bought a per-client licence from us in writing. Each client you deliver a Document to counts as a separate organization that needs its own licence.

7.4What you may not do

Except as section 7.2 or section 7.3 expressly allows, or as we agree in writing, you may not, and may not let anyone else:

• sell, resell, sublicense, rent, lend, transfer or otherwise commercialize a Document;
• share, send or show a Document to anyone outside Your Organization, or publish it on a website, blog, social network, forum, newsletter or press article;
• upload a Document to a shared drive, cloud folder, workspace or link that people outside Your Organization can open, or to a document-sharing, file-hosting or paper-sharing site;
• use a Document or Site Content to build, populate or enrich any database, dataset, index, directory, product or service, whether for sale or not;
• use a Document or Site Content to train, fine-tune, test or evaluate any artificial intelligence or machine-learning model, or to power a retrieval, search, question-answering or other AI service, including by putting it in a prompt, knowledge base or vector store that is offered to people outside Your Organization;
• remove, hide or change any notice, watermark, identifier or metadata in a Document or on the Service;
• combine Documents from several purchases so that people outside Your Organization can use them;
• use a Document in any way that breaks the law or another person's rights.

These restrictions continue after your account closes.

7.5Why these rules apply to every document

Some text in a Document may not be protected by copyright (see section 9). Your obligations in this section are contractual. You agree to them in exchange for access to the Service and the Documents, and they apply whatever the copyright status of the underlying text.

7.6Each copy carries an identifying mark

Documents are for Your Organization's internal use only, not for resale or redistribution. To protect that, every Document file we deliver is marked on each page with the email address of the account it was delivered to and a code unique to that order, and the code is also stored in the file. We keep a record of which code went to which account and order, and we may use it to find the source of a copy shared or sold in breach of these Terms.

8.Using the site

You may view Site Content for your own information and for Your Organization's internal business purposes. You may share a link to a public page on the Service. Any other copying, publishing or reuse of Site Content needs our written permission.

When you use the Service you must not, and must not help anyone else to:

• scrape, crawl, spider or harvest the Service or any Site Content, or use bots, scripts or other automated means to access, search, copy or download from it, except for general-purpose search engines that follow our robots.txt;
• download Documents or Site Content in bulk or faster than a person reasonably could by hand, or get around download limits, prices, the first-document offer or other restrictions;
• get around, disable or interfere with any security, access control, rate limit, paywall or site-access gate;
• copy, decompile, reverse-engineer or try to extract the source code, data structure or databases behind the Service, except where the law allows this despite this restriction;
• use the Service, Documents or Site Content to build or improve a product or service that competes with FDA Intel, or to benchmark the Service for a competitor;
• frame or mirror the Service, or pass off Site Content as your own;
• upload malware, probe or test the Service's vulnerability, or put an unreasonable load on our systems;
• use the Service to harass, threaten or harm anyone, including any person named in a Document;
• impersonate anyone or misrepresent your connection with any person or organization;
• use the Service in a way that breaks any law or regulation.

If you want to use our data in bulk, through an interface or in a product, write to info@fdaintel.ai. We may offer a separate licence.

9.Intellectual property

We want to be clear about who owns what.

• Government text. Text written by employees of the U.S. federal government as part of their official duties, such as the observations in an FDA Form 483 or the body of a warning letter, may be a work of the U.S. government that is not protected by copyright in the United States. We do not claim copyright in that text itself.
• Firms' text. Responses, letters and attachments written by inspected firms or their advisers may be protected by copyright owned by those firms or their authors. You must respect those rights.
• Our work. Cortex Group and its licensors own all rights in the Service and in the work we add: the selection, collection, arrangement and cleaning of the Documents; our scans and file versions; our metadata, classifications, summaries, profiles, analysis, statistics, data and databases; and our software, design, text, logos and the FDA Intel name and marks. These are protected by copyright, database, trademark and other laws.

We grant you only the rights these Terms expressly give you. Everything else is reserved. The licence and restrictions in section 7 and section 8 apply in full even where a Document or part of it is not protected by copyright, because they are part of our agreement with you.

If you send us ideas or feedback, we may use them freely without paying you or owing you anything.

10.About the documents and our data

FDA Intel is independent. We are not affiliated with, endorsed by or acting for the U.S. Food and Drug Administration or any other government agency. References to the FDA describe where a record comes from; they do not mean the FDA approves the Service.

Documents are provided as obtained. We collect Documents from a range of lawful sources and make them available in the form we obtained them, sometimes cleaned up for readability. A Document may be redacted, partial, out of date, poorly scanned, converted by optical character recognition (OCR) with errors, or contain mistakes made by its original author. A later version, correction or response may exist that we do not have.

Our summaries and data are automated. Profiles, summaries, classifications, investigator and firm matches, statistics, charts and search results are produced largely by automated processes, including AI tools, and may be incomplete, out of date or wrong. Always check the Document itself before relying on anything we say about it.

No guarantee of coverage. We do not promise that the Service is complete or current, that a particular Document or record exists or is in our collection, or that any Document will stay available. We may add, change, re-price or remove Documents and Site Content at any time. Removing a Document does not entitle you to a refund except as our Refund Policy says.

People named in records. Documents can include the names of FDA investigators, firm employees and other people as they appear in official records. We show them because they are part of the record. If you are named and want something corrected or reviewed, see section 12.

11.Not advice

The Service and everything on it are for general information only. Nothing on FDA Intel is legal, regulatory, compliance, medical, financial or investment advice, and using the Service does not create any professional or advisory relationship with us. Get advice from a qualified professional before making decisions based on a Document or on Site Content. You are solely responsible for how you use what you find.

12.Copyright, corrections and takedown

If you believe something on the Service infringes your copyright, contains an error, or includes personal information that should be reviewed, tell us at info@fdaintel.ai. Our copyright, corrections and takedown page explains what to include and how we handle requests. We review requests case by case and may keep, correct, redact or remove material at our discretion and as the law requires.

We may close the accounts of people who repeatedly infringe others' rights.

13.Other services and links

The Service relies on other providers, such as our payment provider for checkout and Google if you choose Google sign-in. Their services are governed by their own terms, and we are not responsible for them. Links to other websites are for convenience only; we do not control or endorse them.

14.Privacy

Our Privacy Policy explains what personal data we collect and how we use it. We may keep and use records of your purchases, downloads and use of the Service to provide the Service, to prevent fraud and to enforce these Terms and your licence, including by giving evidence of delivery to our payment provider or a card network in a payment dispute.

15.Disclaimer of warranties

TO THE FULLEST EXTENT THE LAW ALLOWS, THE SERVICE, THE DOCUMENTS AND ALL SITE CONTENT ARE PROVIDED "AS IS" AND "AS AVAILABLE", WITH ALL FAULTS AND WITHOUT WARRANTIES OF ANY KIND, WHETHER EXPRESS, IMPLIED OR STATUTORY. WE DISCLAIM ALL WARRANTIES, INCLUDING ANY WARRANTY OF MERCHANTABILITY, SATISFACTORY QUALITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE, NON-INFRINGEMENT, ACCURACY, COMPLETENESS AND QUIET ENJOYMENT, AND ANY WARRANTY ARISING FROM A COURSE OF DEALING OR USAGE OF TRADE.

In particular, we do not promise that the Service will be uninterrupted, secure or free of errors or harmful components, that defects will be fixed, or that any Document or Site Content is accurate, complete, current or suitable for your purpose.

Some places do not allow certain warranties to be excluded. In those places, the exclusions apply only as far as the law allows.

16.Limitation of liability

TO THE FULLEST EXTENT THE LAW ALLOWS:

1. NEITHER CORTEX GROUP NOR ITS OWNERS, PERSONNEL, CONTRACTORS, LICENSORS OR SUPPLIERS WILL BE LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, EXEMPLARY OR PUNITIVE DAMAGES, OR FOR ANY LOSS OF PROFITS, REVENUE, BUSINESS, CONTRACTS, GOODWILL, ANTICIPATED SAVINGS OR DATA, OR ANY REGULATORY OUTCOME, ARISING OUT OF OR IN CONNECTION WITH THE SERVICE, THE DOCUMENTS, SITE CONTENT OR THESE TERMS, EVEN IF WE WERE TOLD SUCH LOSS WAS POSSIBLE;
2. OUR TOTAL LIABILITY FOR ALL CLAIMS ARISING OUT OF OR IN CONNECTION WITH THE SERVICE, THE DOCUMENTS, SITE CONTENT OR THESE TERMS, TOGETHER, WILL NOT EXCEED THE GREATER OF (A) THE AMOUNTS YOU PAID FOR PURCHASES THROUGH THE SERVICE (INCLUDING AMOUNTS PAID TO OUR PAYMENT PROVIDER AS OUR RESELLER) IN THE 12 MONTHS BEFORE THE EVENT GIVING RISE TO THE FIRST CLAIM, AND (B) 100 U.S. DOLLARS.

These limits apply to every kind of claim, whether in contract, tort (including negligence), breach of statutory duty, misrepresentation or otherwise, and even if a remedy fails of its essential purpose. They do not limit liability that cannot be limited by law, such as liability for death or personal injury caused by negligence, or for fraud or willful misconduct.

The prices of the Service reflect these limits, which are an essential part of our agreement.

17.Your responsibility for claims

You will defend, indemnify and hold harmless Cortex Group and its owners, personnel, contractors, licensors and suppliers from and against any claims, demands, losses, damages, penalties, costs and expenses (including reasonable legal fees) arising out of or related to: (a) your use or misuse of the Service, a Document or Site Content; (b) your breach of these Terms, including the licence rules in section 7 and section 8; (c) your violation of any law or regulation; or (d) your violation of anyone else's rights, including intellectual property, privacy or publicity rights. We may take control of the defense of any such claim at your cost, and you will cooperate with us.

18.Suspension and termination

You may stop using the Service and ask us to close your account at any time by writing to info@fdaintel.ai.

We may suspend, restrict or close your account, refuse service, block access, or end any licence granted under these Terms, at any time, with or without notice, if we reasonably believe you have breached these Terms, misused a Document, made an unjustified chargeback, abused the first-document offer or the refund process, put the Service or others at risk, or if we must do so by law. We may also discontinue the Service, or any part of it, for any reason.

If your licence ends because of your breach, you must stop using and delete all copies of the affected Documents, and you are not entitled to a refund. If we close the Service or your account for any other reason, the licence to Documents you have already downloaded continues on these Terms.

Sections that by their nature should survive termination, including section 7.4, section 7.5, section 8, section 9 and section 15 to section 25, survive.

Breaching the licence or use rules may cause us harm that money alone cannot fix. We may seek an injunction or other urgent relief, in addition to any other remedy, and claim compensation for unauthorized use, including at least the price of every Document shared or used without a licence.

19.Changes to the Service, prices and these Terms

We may change the Service, its features and its prices at any time.

We may update these Terms, the Privacy Policy or the Refund Policy. We will post the new version on this page and change the date and version at the top. Changes take effect when posted. A material change applies to purchases made after it is posted, and does not change the terms of a purchase you already made. Where the law requires, or where we think it fair, we will also tell you by email or on the Service. If you keep using the Service after a change, you accept it; if you do not agree, stop using the Service.

20.Governing law and courts

These Terms, and any dispute or claim arising out of or in connection with them, the Service, any Document or Site Content (including non-contractual disputes or claims), are governed by the laws of the State of Israel, without regard to its conflict-of-laws rules. The United Nations Convention on Contracts for the International Sale of Goods does not apply.

The competent courts located in Tel Aviv-Jaffa, Israel, have exclusive jurisdiction over any such dispute or claim. You and we each submit to the jurisdiction of those courts and waive any objection to them, including on grounds of inconvenient forum.

Despite the paragraph above, we may bring proceedings for an injunction, specific performance or other urgent or equitable relief, or to protect our intellectual property or enforce the licence in section 7, in any court of competent jurisdiction anywhere in the world.

If you are a consumer and the law where you live gives you a mandatory right to bring proceedings in your local courts or to rely on mandatory protections of your local law, nothing in this section takes that right away.

21.Class action and jury waiver

TO THE EXTENT THE LAW ALLOWS, YOU AND WE EACH AGREE TO BRING ANY CLAIM ONLY IN AN INDIVIDUAL CAPACITY, AND NOT AS A PLAINTIFF, CLAIMANT OR CLASS MEMBER IN ANY PURPORTED CLASS, COLLECTIVE, CONSOLIDATED, PRIVATE ATTORNEY GENERAL OR OTHER REPRESENTATIVE PROCEEDING. A court may not consolidate more than one person's claims or preside over any form of representative or class proceeding under these Terms, except where the law does not allow this waiver.

TO THE EXTENT THE LAW ALLOWS, YOU AND WE EACH WAIVE ANY RIGHT TO A TRIAL BY JURY in any proceeding arising out of or related to these Terms, the Service or any Document.

22.Time limit for claims

To the extent the law allows, any claim you have arising out of or in connection with the Service, a Document or these Terms must be started within one (1) year after the claim arose. After that, the claim is permanently barred.

23.Export controls and sanctions

You must comply with all export control and economic sanctions laws that apply to you and to the Service, including those of the United States, the European Union, the United Kingdom and Israel. You confirm that you are not located in, organized in or ordinarily resident in a country or region subject to comprehensive sanctions, and that you are not on, or owned or controlled by anyone on, a government list of restricted or sanctioned parties. You will not use, export or re-export the Service or any Document in breach of those laws.

24.Business users and consumers

The Service is designed for professional and business use, and we expect most customers to buy for their work. If you are a consumer, you may have rights under the mandatory law of the country where you live that cannot be excluded by contract. Nothing in these Terms affects those rights. Any part of these Terms that would limit them does not apply to you to that extent.

25.General terms

• Entire agreement. These Terms, together with the Privacy Policy, the Refund Policy and any extra terms you accept for a specific plan or licence, are the whole agreement between you and us about the Service, and replace any earlier understanding. Any purchase order or other terms you send us do not apply.
• Severability. If a court finds any part of these Terms invalid or unenforceable, that part will be enforced as far as possible or limited to the minimum extent needed, and the rest stays in effect.
• Assignment. You may not assign or transfer these Terms or any licence without our written consent. We may assign or transfer these Terms, in whole or in part, without your consent, including as part of a sale, merger, reorganization or transfer of the Service.
• No waiver. If we do not enforce a right or act on a breach, we have not waived that right or any later breach. A waiver is effective only if it is in writing.
• Events outside our control. We are not liable for any delay or failure caused by events beyond our reasonable control, such as outages of hosting, payment or network providers, cyberattacks, power failures, natural disasters, epidemics, war, hostilities, terrorism, civil unrest, labor disputes or government action.
• Notices and electronic communications. We may send you notices by email to the address on your account, or by posting them on the Service. Email notices count as received when sent. You agree to receive communications from us electronically, and you agree that these satisfy any legal requirement that a communication be in writing. Send notices to us at info@fdaintel.ai.
• Relationship. Nothing in these Terms creates a partnership, joint venture, employment or agency relationship between you and us.
• No third-party rights. These Terms do not give rights to anyone other than you and us, except that the people and suppliers protected by section 16 and section 17 may rely on them.
• Language and headings. These Terms are written in English, and the English version controls. Headings and the plain-English summary are for convenience only and do not change the meaning of the numbered sections.

26.Contact

FDA Intel is operated by Cortex Group. Questions about these Terms: info@fdaintel.ai.