End User License Agreement

Last updated October 6, 2026

This End User License Agreement ("Agreement") is entered into between Poolsoft, LLC ("Company," "we," "us," or "our") and the entity or individual agreeing to these terms ("Customer," "you," or "your") governing access to and use of PreDF ("Software"), including any associated documentation, updates, and hosted services (collectively, the "Service"). By accessing or using the Software, you agree to be bound by this Agreement. If you are entering into this Agreement on behalf of a company or other legal entity, you represent that you have authority to bind that entity.

This Agreement governs use of the Software itself. Use of our website is governed separately by our Terms and Conditions, and our data practices are described in our Privacy Policy.

1. License Grant

Subject to your compliance with this Agreement and payment of applicable fees, Company grants you a limited, non-exclusive, non-transferable, non-sublicensable license to access and use the Software during the term of your subscription, solely for your internal business purposes in accordance with the Documentation.

2. Restrictions

You will not, and will not permit any third party to:

• Copy, modify, or create derivative works of the Software;
• Reverse engineer, decompile, disassemble, or otherwise attempt to derive source code from the Software, except to the extent such restriction is prohibited by applicable law;
• Sell, resell, license, sublicense, distribute, rent, or lease the Software, or use it to provide services to third parties (e.g., as a service bureau), except as expressly permitted under a separate written agreement with Company;
• Remove, obscure, or alter any proprietary notices on the Software;
• Use the Software to build a competing product or service;
• Circumvent or attempt to circumvent any usage limits, security measures, or access controls;
• Use the Software in violation of any applicable law or regulation, including regulations governing the pharmaceutical products, submissions, or data at issue.

3. Customer Data and Content

3.1 Ownership

As between the parties, Customer retains all right, title, and interest in and to the documents, files, and other content Customer uploads, submits, or generates using the Software ("Customer Data"). Company claims no ownership rights in Customer Data.

3.2 License to Company

Customer grants Company a limited license to access, host, process, and transmit Customer Data solely as necessary to provide, maintain, secure, and support the Service, and to improve Company's products (in de-identified or aggregated form only, unless otherwise agreed).

3.3 Confidentiality

Company will treat Customer Data as confidential and will not disclose it to third parties except: (a) as necessary to provide the Service (e.g., to subprocessors bound by confidentiality obligations), (b) with Customer's consent, or (c) as required by law.

3.4 Data Processing Agreement

To the extent Customer Data includes personal data subject to applicable data protection law, the parties will enter into a separate Data Processing Agreement, which will be incorporated by reference into this Agreement.

4. Regulatory Disclaimer

The Software is a tool to assist with the formatting, report level or document level publishing, and quality control of regulatory documents. Company is not a regulatory consultant, law firm, or agent of any regulatory authority. Use of the Software does not guarantee:

• Compliance with FDA, EMA, or any other regulatory authority's requirements;
• Acceptance, approval, or non-rejection of any submission;
• Accuracy or completeness of any document produced using the Software.

Customer is solely responsible for:

• Reviewing and validating all output produced using the Software before submission to any regulatory authority;
• Ensuring Customer's own use of the Software complies with applicable regulatory requirements, including, where applicable, 21 CFR Part 11 and equivalent international regulations;
• Independently validating the Software for its intended use within Customer's own quality system, to the extent required by Customer's regulatory obligations.

Company will provide reasonable documentation to support Customer's vendor qualification and validation efforts upon request, as described in Company's standard vendor qualification package (available upon request).

5. Fees and Payment

Fees for the Service are as set out in the applicable order form, invoice, or subscription plan. Unless otherwise stated: fees are due in advance on an annual basis unless otherwise stated, are nonrefundable except as required by law or expressly stated in this Agreement, and are exclusive of taxes, which Customer is responsible for (excluding taxes on Company's net income). Late payments may result in suspension of access to the Service after notice.

6. Term and Termination

6.1 Term

This Agreement remains in effect for as long as Customer maintains an active subscription, unless earlier terminated as provided below.

6.2 Termination for Convenience

Either party may decline to renew a subscription by providing notice in accordance with the applicable order form.

6.3 Termination for Cause

Either party may terminate this Agreement if the other party materially breaches this Agreement and fails to cure such breach within thirty (30) days of written notice.

6.4 Effect of Termination

Upon termination, Customer's right to access the Service ends immediately. Company will make Customer Data available for export for a period of thirty (30) days following termination, after which Company may delete Customer Data, except as required to be retained by law.

7. Service Availability and Support

Company will use commercially reasonable efforts to make the Service available, excluding scheduled maintenance and circumstances beyond Company's reasonable control. Company will provide reasonable advance notice of changes to the Software that may materially affect previously validated functionality, where feasible.

8. Intellectual Property

Company retains all right, title, and interest in and to the Software, including all underlying technology, algorithms, and improvements, whether or not incorporating Customer feedback. No rights are granted to Customer other than the limited license expressly set forth in Section 1. Any feedback Customer provides about the Software may be used by Company without restriction or obligation.

9. Warranties and Disclaimers

Company warrants that it will perform the Service in a professional manner consistent with general industry standards.

EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, THE SOFTWARE AND SERVICE ARE PROVIDED "AS IS," WITHOUT WARRANTY OF ANY KIND, WHETHER EXPRESS, IMPLIED, OR STATUTORY, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE, AND NON-INFRINGEMENT. COMPANY DOES NOT WARRANT THAT THE SOFTWARE WILL BE UNINTERRUPTED, ERROR-FREE, OR THAT ANY OUTPUT WILL SATISFY ANY REGULATORY REQUIREMENT OR RESULT IN SUBMISSION ACCEPTANCE.

10. Limitation of Liability

TO THE FULLEST EXTENT PERMITTED BY LAW: NEITHER PARTY WILL BE LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, OR PUNITIVE DAMAGES, OR ANY LOSS OF PROFITS, REVENUE, DATA, OR BUSINESS OPPORTUNITY, ARISING OUT OF OR RELATED TO THIS AGREEMENT, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

EACH PARTY'S TOTAL AGGREGATE LIABILITY ARISING OUT OF OR RELATED TO THIS AGREEMENT WILL NOT EXCEED THE FEES PAID BY CUSTOMER TO COMPANY IN THE TWELVE (12) MONTHS PRECEDING THE CLAIM.

The limitations in this section will not apply to: (a) either party's indemnification obligations, (b) breach of confidentiality obligations, or (c) a party's gross negligence or willful misconduct, in each case to the extent such exclusion is permitted by applicable law.

11. Indemnification

By Company: Company will defend Customer against any third-party claim alleging that the Software, as provided by Company and used in accordance with this Agreement, infringes such third party's intellectual property rights, and will indemnify Customer for damages finally awarded, provided Customer promptly notifies Company of the claim and cooperates in its defense.

By Customer: Customer will defend and indemnify Company against any third-party claim arising from: (a) Customer Data, (b) Customer's use of the Software in violation of this Agreement or applicable law, or (c) Customer's regulatory submissions or decisions made using output from the Software.

12. Confidentiality

Each party may have access to the other's confidential information. Each party agrees to protect the other's confidential information using the same degree of care it uses for its own confidential information of similar nature, and not less than reasonable care, and to use such information solely to perform its obligations under this Agreement.

13. Changes to This Agreement

Company may update this Agreement from time to time. For material changes, Company will provide reasonable notice (e.g., by email or in-product notice) before the changes take effect. Continued use of the Service after the effective date of any update constitutes acceptance of the revised Agreement.

14. Governing Law and Dispute Resolution

This Agreement is governed by the laws of the State of North Carolina, without regard to its conflict-of-laws principles. Any dispute arising out of or relating to this Agreement will be resolved exclusively in the state or federal courts located in Wake County, North Carolina, and the parties consent to the jurisdiction of such courts.

15. General Provisions

• Assignment: Neither party may assign this Agreement without the other's prior written consent, except in connection with a merger, acquisition, or sale of substantially all assets.
• Force Majeure: Neither party will be liable for delays or failures in performance resulting from circumstances beyond its reasonable control.
• Severability: If any provision of this Agreement is found unenforceable, the remaining provisions will remain in full effect.
• Entire Agreement: This Agreement, together with any order form, SLA, and DPA, constitutes the entire agreement between the parties regarding the Software and supersedes all prior agreements on the subject.
• No Waiver: Failure to enforce any provision of this Agreement will not constitute a waiver of that provision.

16. Contact Us

Questions about this Agreement can be directed to:

Poolsoft, LLC
3908 Brenton Glen Ct., Fuquay-Varina, NC 27526
info@poolsoft.net