Terms of Service

1. Agreement

These Terms of Service ("Terms") govern your access to and use of kataiyzeai.com and the AI-assisted pharmaceutical quality workflow automation platform operated by Katalyze AI, Inc. ("the Company," "we," "us," or "our"), with a principal place of business at 245 Main Street, Suite 1400, Boston, MA 02142. By accessing or using the Service, you agree to be bound by these Terms. If you are accepting on behalf of a company or other legal entity, you represent that you have the authority to bind that entity. If you do not agree, do not use the Service.

The Service is designed for use by business customers in regulated pharmaceutical and biotech manufacturing environments. Individual consumer use is not contemplated, and nothing in these Terms creates any duty owed by the Company to end patients or other third parties outside the customer's organization.

2. Use of the Service

• You must be at least 18 years old and acting in a professional capacity on behalf of an authorized organization to use the Service.
• You agree not to use the Service for unlawful purposes, to interfere with its operation, or to attempt unauthorized access to systems or data, including the data of other customers.
• You may not reverse-engineer, scrape, or copy the Service except as permitted by applicable law.
• You are responsible for maintaining the confidentiality of your account credentials and for all activities that occur under your account. Notify us promptly at [email protected] if you suspect unauthorized use.
• The AI review features of the Service prepare analysis and flag exceptions to assist human reviewers. The qualified reviewer within your organization retains final authority over all quality decisions, batch release determinations, and regulatory submissions. The Company does not make or warrant quality decisions on your behalf.

3. Intellectual Property

The Service, including all underlying software, AI models, algorithms, user interface elements, and documentation, is owned by Katalyze AI, Inc. or its licensors and is protected by United States and international intellectual-property laws. We grant you a limited, non-exclusive, non-transferable, revocable license to access and use the Service solely for your organization's internal quality management purposes during your subscription term.

You retain all rights to the manufacturing documentation, batch records, deviation reports, and other data you submit to the Service ("Customer Data"). You grant the Company a limited license to process Customer Data as necessary to provide the Service and fulfill our obligations to you. We do not use Customer Data to train or improve AI models.

4. Customer Data and Acceptable Use

You are responsible for ensuring that Customer Data you submit to the Service complies with applicable laws and regulations, including any obligations that apply to electronic records under 21 CFR Part 11 or equivalent frameworks in your jurisdiction. You represent that you have all rights necessary to submit Customer Data for processing through the Service.

You grant the Company a limited license to use, store, and process Customer Data as necessary to provide the Service, generate review outputs, and respond to your support requests. The Company will not access Customer Data except as necessary to operate and support the Service or as required by law.

5. Disclaimers

THE SERVICE IS PROVIDED "AS IS" AND "AS AVAILABLE." TO THE MAXIMUM EXTENT PERMITTED BY LAW, KATALYZE AI, INC. DISCLAIMS ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND NON-INFRINGEMENT. THE COMPANY DOES NOT WARRANT THAT THE SERVICE WILL BE UNINTERRUPTED, ERROR-FREE, OR FREE OF HARMFUL COMPONENTS. THE AI REVIEW OUTPUTS GENERATED BY THE SERVICE ARE PREPARED FOR USE BY QUALIFIED HUMAN REVIEWERS AND DO NOT CONSTITUTE REGULATORY SUBMISSIONS, QUALITY RELEASE DECISIONS, OR COMPLIANCE CERTIFICATIONS.

6. Limitation of Liability

TO THE MAXIMUM EXTENT PERMITTED BY LAW, KATALYZE AI, INC. AND ITS OFFICERS, DIRECTORS, EMPLOYEES, AND AGENTS WILL NOT BE LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, OR PUNITIVE DAMAGES ARISING FROM OR IN CONNECTION WITH YOUR USE OF THE SERVICE, INCLUDING ANY ADVERSE REGULATORY FINDING, PRODUCT RECALL, BATCH REJECTION, OR INSPECTION OBSERVATION, EVEN IF THE COMPANY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. OUR TOTAL LIABILITY FOR ANY CLAIM ARISING FROM OR RELATED TO THESE TERMS OR THE SERVICE WILL NOT EXCEED THE FEES PAID BY YOU TO THE COMPANY IN THE THREE MONTHS PRECEDING THE CLAIM, OR USD $100 IF NO FEES HAVE BEEN PAID.

Some jurisdictions do not permit the exclusion of certain warranties or the limitation of certain damages. In those jurisdictions, our liability will be limited to the maximum extent permitted by law.

7. Indemnification

You agree to defend, indemnify, and hold harmless Katalyze AI, Inc. and its officers, directors, employees, and agents from any claims, damages, liabilities, costs, and expenses (including reasonable attorneys' fees) arising from (a) your use of the Service in violation of these Terms or applicable law, (b) Customer Data you submit to the Service, or (c) your violation of any third-party right.

8. Termination

Either party may terminate the use of the Service in accordance with the subscription agreement. The Company may also suspend or terminate access to the Site at any time, with or without notice, for violation of these Terms. Sections that by their nature should survive termination will survive, including Sections 3, 5, 6, 7, 9, and 10. Upon termination, the Company will make Customer Data available for export for 30 days before deletion in accordance with our data retention practices.

9. Governing Law; Dispute Resolution

These Terms are governed by the laws of the Commonwealth of Massachusetts, without regard to its conflict-of-law principles.

Informal Resolution. Before filing a formal claim, you agree to contact us at [email protected] and attempt to resolve the dispute informally for at least 60 days. Most issues affecting quality teams can be resolved through direct conversation with our team.

Arbitration. Any dispute that cannot be resolved informally will be settled by binding arbitration administered in Massachusetts, USA under the rules of the American Arbitration Association ("AAA"). Judgment on the arbitrator's award may be entered in any court of competent jurisdiction. You and the Company each waive the right to a jury trial and the right to participate in a class action.

Exception. Either party may seek injunctive or other equitable relief in a court of competent jurisdiction located in Massachusetts, USA for intellectual-property infringement or unauthorized access to the Service, without first engaging in informal resolution or arbitration.

10. Changes to These Terms

We may update these Terms from time to time. Material changes will be posted with a new "Last updated" date and, where appropriate, communicated to active customers. Continued use of the Service after the effective date of updated Terms constitutes acceptance of those Terms.

11. Contact