§ 01

Acceptance of Terms

By accessing or using labelmonitor.com (the "Website") or the LabelMonitor software platform (the "Service"), you agree to be bound by these Terms of Use ("Terms"). If you are using the Service on behalf of an organisation, you represent that you have authority to bind that organisation to these Terms, and references to "you" include that organisation.

If you do not agree to these Terms, do not use the Website or Service.

§ 02

Service Description

LabelMonitor is a software-as-a-service platform that monitors FDA drug label changes published via DailyMed Structured Product Labeling (SPL) XML, scores detected changes against configurable severity rules, and provides workflow tools for pharmaceutical regulatory affairs teams to review, adjudicate, and document their assessments.

The Service is designed to support — not replace — the professional judgment of qualified regulatory affairs personnel. Features include:

• Automated monitoring of DailyMed SPL XML for section-level label changes
• Rules-based severity scoring with references to 21 CFR 314.70 filing classifications
• Adjudication workflow with immutable, timestamped audit records
• Inspection-ready dossier export

§ 03

Eligibility

The Service is intended for use by professionals employed at pharmaceutical manufacturers, contract research organisations, regulatory consulting firms, and related entities in regulated industries. You must be at least 18 years of age and have the authority to enter into these Terms on behalf of yourself or your organisation.

Use of the Service by individuals or organisations for purposes unrelated to pharmaceutical regulatory affairs is not permitted.

§ 04

Accounts & Access

Access to the LabelMonitor platform requires a verified account. You are responsible for:

• Maintaining the confidentiality of your login credentials
• All activity that occurs under your account
• Notifying us immediately of any unauthorised use of your account at hello@labelmonitor.com

Account sharing is not permitted. Each user must have their own individual account. You may not transfer your account to another person or organisation without our written consent.

We reserve the right to suspend or terminate accounts that we reasonably believe are being used in violation of these Terms, without prior notice where required to protect the security or integrity of the Service.

§ 05

Acceptable Use

You agree to use the Service only for lawful purposes and in accordance with these Terms. You must not:

• Use the Service in any way that violates applicable law or regulation
• Attempt to gain unauthorised access to any part of the Service, other user accounts, or our infrastructure
• Introduce malware, viruses, or other malicious code into the Service
• Use automated means to scrape, crawl, or extract data from the Service beyond normal API usage
• Reverse engineer, decompile, or disassemble the Service
• Resell, sublicense, or otherwise make the Service available to third parties without our written consent
• Use the Service to process data in violation of applicable privacy laws
• Misrepresent the outputs of the Service as binding regulatory determinations

§ 06

No Regulatory Advice

LabelMonitor provides decision-support information only. Nothing in the Service — including severity scores, filing classification suggestions, change summaries, or any other output — constitutes:

• Legal advice
• Regulatory advice
• A binding compliance determination
• A representation that any particular regulatory filing is or is not required
• A substitute for review by a qualified regulatory affairs professional

Severity classifications and filing suggestions (CBE-0, CBE-30, PAS, Annual Report) are generated by automated rules applied to publicly available FDA data. They are intended to prioritise your team's attention — they are not legal conclusions. Your organisation's qualified regulatory affairs personnel must independently evaluate every detected change and determine the appropriate regulatory response.

You assume sole responsibility for all regulatory decisions made by your organisation, including any decision to file or not file a submission with the FDA or other regulatory authority.

§ 07

Intellectual Property

The LabelMonitor platform, including its software, algorithms, user interface, documentation, and all associated intellectual property, is owned by LabelMonitor and protected by copyright, trade secret, and other applicable laws.

These Terms grant you a limited, non-exclusive, non-transferable, revocable licence to use the Service for your internal business purposes during the term of your subscription. No other licence is granted.

FDA DailyMed data processed by the Service is in the public domain as a work of the United States federal government. LabelMonitor's processing, normalisation, and analysis of that data is proprietary.

§ 08

Your Data

You retain ownership of all data you upload to or generate within the Service ("Customer Data"), including your product portfolio, adjudication records, and annotations.

You grant LabelMonitor a limited licence to process Customer Data solely to provide the Service to you. We do not use Customer Data to train models, benchmark against other customers, or for any purpose other than operating and improving the Service for your use.

Upon termination of your subscription, we will make Customer Data available for export for 30 days, after which it will be deleted in accordance with our data retention policy, except where retention is required by law.

You are responsible for ensuring that Customer Data you upload does not violate any third-party rights or applicable law.

§ 09

Availability & SLA

During the early access programme, the Service is provided on a best-efforts basis without a formal uptime commitment. We will use reasonable efforts to maintain availability and to notify early access participants of planned maintenance.

Formal SLA commitments (including uptime targets and alert delivery SLAs) will be specified in the subscription agreement for production customers following general availability.

§ 10

Disclaimers

THE SERVICE IS PROVIDED "AS IS" AND "AS AVAILABLE" WITHOUT WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT, OR THAT THE SERVICE WILL BE UNINTERRUPTED, ERROR-FREE, OR SECURE.

We do not warrant that the Service will detect every label change published to DailyMed, that severity scores will be accurate or complete, or that the Service will meet your specific regulatory compliance requirements.

Some jurisdictions do not allow the exclusion of implied warranties. In such jurisdictions, the above exclusions apply to the fullest extent permitted by law.

§ 11

Limitation of Liability

TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, LABELMONITOR SHALL NOT BE LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, OR PUNITIVE DAMAGES, INCLUDING BUT NOT LIMITED TO LOSS OF PROFITS, LOSS OF DATA, REGULATORY FINES OR PENALTIES, OR COSTS OF SUBSTITUTE SERVICES, ARISING OUT OF OR RELATED TO YOUR USE OF OR INABILITY TO USE THE SERVICE, EVEN IF WE HAVE BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

IN NO EVENT SHALL LABELMONITOR'S TOTAL CUMULATIVE LIABILITY ARISING OUT OF OR RELATED TO THESE TERMS OR THE SERVICE EXCEED THE GREATER OF (A) THE AMOUNTS PAID BY YOU TO LABELMONITOR IN THE TWELVE MONTHS PRECEDING THE CLAIM, OR (B) ONE HUNDRED US DOLLARS (USD $100).

These limitations apply regardless of the theory of liability (contract, tort, statute, or otherwise) and even if any limited remedy fails of its essential purpose.

§ 12

Indemnification

You agree to indemnify, defend, and hold harmless LabelMonitor and its officers, directors, employees, and agents from and against any claims, damages, losses, costs, and expenses (including reasonable legal fees) arising out of or related to: (a) your use of the Service in violation of these Terms; (b) your violation of any applicable law or regulation; (c) any regulatory action arising from decisions made by your organisation based on Service outputs; or (d) your Customer Data.

§ 13

Termination

You may stop using the Service at any time. For early access participants, contact hello@labelmonitor.com to request removal from the programme.

We may suspend or terminate your access to the Service at any time, with or without cause, with reasonable notice where practicable. We may terminate immediately where we reasonably believe there is a security risk or material breach of these Terms.

Upon termination, all licences granted under these Terms cease immediately. Sections 6, 7, 10, 11, 12, and 14 survive termination.

§ 14

Governing Law

These Terms are governed by and construed in accordance with the laws of the State of Delaware, United States, without regard to conflict of law principles. Any dispute arising under these Terms shall be subject to the exclusive jurisdiction of the state and federal courts located in Delaware.

If you are located in the European Union or United Kingdom, nothing in these Terms affects your rights under applicable mandatory consumer or data protection law.

§ 15

Changes to Terms

We may update these Terms from time to time. Material changes will be communicated by email and/or a prominent notice on this page at least 14 days before they take effect. The "Effective date" at the top of this page will be updated with each revision.

Continued use of the Service after updated Terms take effect constitutes acceptance of the revised Terms. If you do not agree to the revised Terms, you must stop using the Service.

§ 16

Contact

For questions about these Terms, contact us at security@labelmonitor.com.

For security concerns, contact privacy@labelmonitor.com.

For privacy and data protection matters, contact hello@labelmonitor.com.