Artificial Intelligence Terms

Per §18 of Master Subscription Agreement v4.0 effective 23-SEP-2026

18 ARTIFICIAL INTELLIGENCE (AI).

18.1 Scope. This Section 18 applies to Customer’s use of AI Features and governs in the event of any conflict with another provision of this Agreement with respect to AI Features, except that Section 13 (Limitation of Liability) governs all liability arising from or relating to AI Features and AI Output.

18.2 Training and Model Development. ZenQMS does not use Customer Data, AI Input, or AI Output to train, fine-tune, or otherwise develop any artificial intelligence or machine learning model that is made available to any other customer or to any third party. ZenQMS may use Customer Data to provide, operate, support, and improve the AI Features for Customer and Customer’s Affiliates. ZenQMS will contractually prohibit each provider of a model or service used to deliver the AI Features from retaining, using, or training on Customer Data, AI Input, or AI Output for any purpose other than providing the applicable service to ZenQMS. Processing of Customer Data by AI Features is not, and does not generate, System Data as defined in Section 17.

18.3 Ownership. As between the parties, AI Input and AI Output are Customer Data and Customer retains all right, title and interest in them, except that ZenAI Content remains the sole property of ZenQMS notwithstanding its incorporation into, or reflection in, any AI Input or AI Output. Customer’s rights in AI Output do not include any right to extract, replicate, reverse engineer, or make derivative use of ZenAI Content. Customer acknowledges that AI Features are generative and that ZenQMS makes no representation that AI Output is unique to Customer or that identical or similar AI Output will not be generated for another customer.

18.4 Human Review and Use in a Regulated Environment. AI Output is a draft. AI Features are decision-support tools and are not a substitute for review, approval, or release by qualified Customer personnel. Customer is solely responsible for establishing and following procedures under which AI Output is reviewed and approved by a qualified individual before it is relied upon, approved, made effective, or used to satisfy any GxP or other regulatory requirement. ZenQMS designs the AI Features so that AI Output does not become an approved or effective controlled document, record, or workflow outcome within the Software without an affirmative action by an authenticated Software user.

18.5 Electronic Signatures. No AI Feature and no Customer AI System may execute an electronic signature within the Software. Electronic signatures must be applied by an individual human being using that individual’s own credentials, as required by Section 3.3 and consistent with 21 CFR Part 11 and EU Annex 11. Customer will not configure or use any Customer AI System in a manner that applies, or attempts to apply, an electronic signature on behalf of a Software user, and customer agrees any such spoofing of electronic signatures is precluded by Section 3.3. ZenQMS will resolve all electronic signatures to a specific authenticated user, and use commercial best efforts to identify and flag any non-human user interactions in the audit trail.

18.6 Traceability. Where an AI Feature is used to generate or materially modify content within a module of the Software that maintains an audit trail, the Software records that an AI Feature was used, the user who invoked it, and the date and time, in the audit trail for the applicable record. Such audit trail entries are retained in accordance with Section 4 of EXHIBIT I.

18.7 Validation and Qualification Evidence. ZenQMS develops, tests, validates, and maintains the AI Features under the policies and standards described in Section 5 of EXHIBIT I and as part of its defined Software Development Life Cycle. Upon written request, ZenQMS will make available to Customer, through the Auditor Share, the specification, testing, validation, and verification documentation for the AI Features for the current production Release, together with a description of the intended use, known limitations, and human-review controls applicable to each AI Feature, in each case to the extent reasonably necessary for Customer to complete its own Risk Assessment and user acceptance testing.

18.8 Notification of Material Changes. ZenQMS maintains the AI Features under its Change Control system. ZenQMS will notify Customer as appropriate through Software Announcements of any change to an AI Feature that ZenQMS reasonably determines would materially alter that AI Feature’s intended use or documented behavior, and will make updated validation documentation available through the Auditor Share. Such notice will be provided in accordance with the applicable Release notice periods set out in Section 8 of EXHIBIT I. Changes to an underlying model, model version, or model provider that do not materially alter an AI Feature’s intended use or documented behavior are treated as System/Configuration updates with updated Change Logs available to Customer.

18.9 Accuracy and Customer Responsibility. Generative artificial intelligence can produce output that is incomplete, inaccurate, or otherwise unreliable. ZenQMS will use commercially reasonable efforts to design and test the AI Features to reduce the likelihood of such output, and will use models that are appropriate for commercial use. ZenQMS does not warrant that AI Output will be accurate, complete, current, fit for any particular purpose, or compliant with any law, regulation, or standard, and the warranties in Section 11.1 do not extend to the content of AI Output. Customer is solely responsible for its use of, and reliance on, AI Output. Nothing in this Section limits ZenQMS’s obligations under Section 11.1 with respect to the availability or performance of the Software itself.

18.10 No Quality or Regulatory Advice. AI Output does not constitute quality, regulatory, scientific, medical, or legal advice, and ZenQMS does not provide such advice through the AI Features. The No Legal Advice provision of Section 19 applies to AI Output, and Customer remains solely responsible for determining whether its use of the Software and any AI Output complies with the laws, regulations, and standards applicable to Customer.

18.11 Acceptable Use. Customer will not, and will not permit any user to: (i) use an AI Feature to generate content that is unlawful, infringing, defamatory, or that Customer is not entitled to submit; (ii) use an AI Feature to develop, train, or benchmark a competing artificial intelligence model or a similar or competitive product or service; (iii) attempt to circumvent, disable, or defeat any human-review control, rate limit, content filter, or safety control applied to an AI Feature; or (iv) represent AI Output as having been reviewed or approved by a qualified individual when it has not.

18.12 Personal Data and Protected Health Information in AI Features. Customer and its users decide what Customer Data to enter into Software. Customer is solely responsible for that determination, including for assessing whether Customer Data made available to AI Features contains Personal Data or Protected Health Information and whether such processing is consistent with Customer's own policies and applicable law. ZenQMS will process any Personal Data or Protected Health Information submitted to or processed by an AI Feature in accordance with Section 15 (Privacy Practices) and any executed Data Processing Addendum or Business Associate Addendum, on the same terms that apply to Customer Data generally, and the commitments in Section 18.2 (Training and Model Development) apply to such data without exception. Where ZenQMS makes a configuration control available to limit the Customer Data accessible to an AI Feature, ZenQMS will describe that control in the documentation made available under Section 18.7 or other Software Announcements.

18.13 Customer AI Systems. Customer’s use of a Customer AI System in conjunction with the Software is subject to Section 3.3 (Usage Limitations), Section 3.4 (Fair Use), and this Section. Customer is solely responsible for the design, configuration, security, performance, and regulatory compliance of each Customer AI System, for all activity conducted through it, and for all output it produces. Customer will ensure that each Customer AI System operates under the direction and control of a named individual Software user to whom its activity is attributed. ZenQMS has no obligation to validate, qualify, support, or maintain compatibility with any Customer AI System.

18.14 AI Credits and Metering. Where an Order Form specifies AI Credits or another consumption-based entitlement for AI Features, Customer’s use of the applicable AI Features is limited to that entitlement. Unless the Order Form states otherwise, AI Credits are allocated per the period stated in the Order Form, do not carry over to a subsequent period, and are not refundable. Additional AI Credits may be purchased during the Subscription Term at the rates set out in the applicable Order Form. ZenQMS may apply reasonable rate limits to AI Features to protect the availability and performance of the Software for all customers. AI Features are excluded from the availability commitment in Section 1 of EXHIBIT I

18.15 Suspension. If ZenQMS reasonably determines that Customer’s or a user’s use of an AI Feature, or a Customer AI System, violates the Acceptable Use provisions of this Section or presents a material risk to the security, integrity, or availability of the Software, ZenQMS may suspend access to the affected AI Feature or Customer AI System. ZenQMS will provide Customer with notice and, where the circumstances reasonably permit, an opportunity to cure before suspending; where they do not, ZenQMS will notify Customer promptly after suspending. Suspension under this Section is limited to the affected AI Feature or Customer AI System and does not affect Customer’s access to the remainder of the Software.

18.16 Professional Services. Where ZenQMS uses artificial intelligence in performing Professional Services, ZenQMS remains responsible for the Deliverables it provides under the applicable SOW to the standard set out in Section 11.1, and Customer’s exclusive remedy and ZenQMS’s entire liability for any breach of that standard is as set out in Section 11.1. This Section does not apply to templates, forms, or preconfigured content provided to Customer on an “as is” basis where the applicable SOW expressly says so.

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