Terms of Service

1. Eligibility

By using our Site or Services, you represent and warrant that you are at least 18 years of age, have the legal capacity to enter into a binding agreement, and are not prohibited from using our Services under any applicable law. If you are using our Services on behalf of a company or other legal entity, you represent that you have the authority to bind that entity to these Terms.

2. Description of Services

Notiva Labs combines AI-powered drafting with human scientific review to provide documentation support based on client-provided inputs. Our Services assist life sciences teams in preparing review-ready draft documentation, such as standard operating procedures (SOPs), process maps, and technical materials.

Notiva Labs operates solely as an outsourced documentation and advisory support provider. Our services are administrative and scientific in nature; Notiva Labs is not a manufacturer, Clinical Research Organization (CRO), testing laboratory, software provider, or regulatory authority. We do not approve documents, release products, perform physical validation or laboratory testing, or provide regulatory certification.

Deliverables consist solely of drafts provided for Client review and do not constitute final, approved, validated, or operational documents. A Deliverable only becomes an operational document once the Client completes its own internal quality review and approval process. All approval, implementation, and ultimate regulatory/compliance responsibilities remain exclusively with the Client.

The specific scope, deliverables, timelines, and pricing for any engagement will be defined in a separate Statement of Work, proposal, or service agreement (“Service Agreement”). In the event of any conflict between these Terms and a Service Agreement, the Service Agreement shall control.

3. User Accounts and Access

Certain features of our Services may require you to create an account or receive access credentials. You are responsible for maintaining the confidentiality of your login credentials and for all activities that occur under your account. You agree to notify us immediately of any unauthorized use of your account.

We reserve the right to suspend or terminate your account at our discretion if we believe your use violates these Terms or poses a security risk.

4. Acceptable Use

You agree not to use the Site or Services to:

• Violate any applicable local, state, national, or international law or regulation.
• Infringe upon the intellectual property, privacy, or other rights of any third party.
• Transmit any malicious software, viruses, or other harmful code.
• Attempt to gain unauthorized access to our systems, networks, or other users’ accounts.
• Interfere with or disrupt the integrity or performance of the Site or Services.
• Use any automated means (bots, scrapers, crawlers) to access, collect, or extract data from the Site without our prior written consent.
• Misrepresent your identity or affiliation with any person or entity.
• Use the Services to produce documentation that is intentionally false, misleading, or fraudulent.

We reserve the right to investigate and take appropriate action, including termination of access, for any violation of this section.

5. Client Content and Data

5.1 Definitions and Data Classification

In the course of using our Services, you may provide us with content, data, documents, specifications, and other materials (collectively, “Client Content”). Client Content is classified into the following categories, each subject to different handling obligations:

• Client Personal Data: Any information within Client Content that identifies or could reasonably be used to identify a natural person, including names, email addresses, employee identifiers, signatures, or any other data classified as “personal data” under the GDPR, “personal information” under the CCPA/CPRA, or “personal data” under the TDPSA. Client Personal Data is subject to the full protections described in our Privacy Policy and any applicable Data Protection Agreement (DPA).
• Client Technical Content: All non-personal business and technical materials provided by the Client, including but not limited to standard operating procedures, process documentation, specifications, formulations, batch records, and technical workflows. Client Technical Content is subject to the contractual protections described in these Terms and any applicable NDA.

Where Client Content contains both Client Personal Data and Client Technical Content (e.g., an SOP with employee names in the “prepared by” field), the personal data components receive the full protections applicable to Client Personal Data, and the technical components are governed as Client Technical Content.

5.2 Ownership and Authorization

You retain all ownership rights in your Client Content. You represent and warrant that you have the legal right and authority to provide all Client Content to Notiva Labs for the purposes of the Services. Notiva Labs works exclusively with client-authorized materials.

5.3 Priority of Agreements

Notiva Labs operates under executed Non-Disclosure Agreements (NDAs) and Data Protection Agreements (DPAs) where applicable. In the event of any conflict between these Terms and an executed NDA or DPA between you and Notiva Labs, the terms of the specific NDA or DPA shall control with respect to the handling and protection of Client Content.

5.4 Limited License

By providing Client Content to us, you grant Notiva Labs a limited, non-exclusive, non-transferable license to use, reproduce, and process your Client Content for the following purposes:

• (a) Delivering the contracted Services;
• (b) Internal quality assurance, validation, and service improvement as described in Section 5.5;
• (c) Creation of Anonymized Derivatives as described in Section 5.6; and
• (d) Creation of Aggregate Statistical Insights as described in Section 5.7.

5.5 Internal Quality Assurance and Service Improvement

Notiva Labs may use Client Content internally for the purpose of evaluating, validating, and improving the quality and effectiveness of our service delivery processes, including testing revised workflows, refining drafting methodologies, and benchmarking deliverable quality. This internal use is subject to the following conditions:

• Sandboxed environment: All quality assurance activities involving Client Content are conducted within our secure infrastructure, subject to the same access controls and security measures applied during the original engagement.
• No direct cross-client use: Client Content in its identifiable form is never shared with, disclosed to, or used directly in deliverables for other clients. Test outputs generated during quality assurance evaluations are discarded after evaluation.
• No model training: Client Content is not used to train, fine-tune, or otherwise modify any artificial intelligence or machine learning model. Quality assurance use is limited to evaluating and benchmarking the outputs of our processes, not modifying AI models themselves.
• IP protection: Any “know-how,” refined prompt structures, workflow improvements, or methodological insights developed by Notiva Labs during the course of providing Services or performing quality assurance remain the sole and exclusive Intellectual Property of Notiva Labs and do not constitute Client Content.
• Confidentiality: All quality assurance activities are subject to the confidentiality obligations in Section 9 of these Terms.
• Retention: Client Content retained for quality assurance is securely deleted upon the completion of the engagement or the termination of the service relationship, subject to a standard administrative wrap-up period not to exceed six (6) months, unless otherwise specified in a Service Agreement.

5.6 Anonymized Derivatives

Notiva Labs may create anonymized, de-identified derivatives of Client Technical Content (“Anonymized Derivatives”) by removing all of the following: client identifiers, trade names, proprietary product names, proprietary process parameters, formulation-specific details, Client Personal Data, and any other information that could reasonably be used to identify the Client or any individual.

Anonymized Derivatives may be used by Notiva Labs for the following purposes:

• Developing and refining internal reference templates and structural frameworks;
• Improving drafting methodologies, prompt engineering, and service delivery processes;
• Building internal quality benchmarks and best-practice guidelines; and
• Training internal staff on documentation standards and regulatory formatting conventions.

Anonymized Derivatives are subject to the following conditions:

• Irreversibility standard: Anonymization must be conducted such that the Client cannot reasonably be re-identified from the derivative, either on its own or in combination with other information available to Notiva Labs. Notiva Labs shall not attempt to re-identify any Anonymized Derivative.
• No personal data: Anonymized Derivatives shall contain no Client Personal Data. Any personal data present in the source material must be removed prior to or during the anonymization process.
• Ownership: Anonymized Derivatives that meet the irreversibility standard set forth above become the property of Notiva Labs. The Client retains no ownership interest in Anonymized Derivatives.
• No trade secret exposure: Anonymization must remove proprietary process parameters, formulation details, and any information that would constitute the Client’s trade secrets. Structural patterns, section ordering conventions, and general formatting approaches are not considered trade secrets of the Client.

5.7 Aggregate Statistical Insights

Notiva Labs may compile aggregate, non-identifiable statistical data derived from its provision of Services across multiple client engagements (“Aggregate Insights”). Aggregate Insights include metrics such as average revision rates by document type, common structural deficiency categories, deliverable accuracy scores, and turnaround time benchmarks.

Aggregate Insights:

• Shall not identify or be attributable to any individual client;
• Are the sole property of Notiva Labs;
• May be used for any lawful business purpose, including marketing, sales, product development, and published benchmarking reports; and
• Are not subject to the deletion or retention obligations applicable to Client Content.

5.8 Voluntary Post-Delivery Benchmarking

To support continuous quality improvement, Notiva Labs may request that the Client voluntarily provide final, approved, or redlined versions of Deliverables after the Client has completed its internal review and approval process (“Benchmarking Content”). Participation in this program is entirely optional.

Any Benchmarking Content provided by the Client:

• Is treated as Client Content and subject to all protections described in this Section 5;
• Is used solely to measure the accuracy and completeness of Notiva Labs’ original draft against the Client’s final approved version;
• Is compared only against Notiva Labs’ own draft for the same Client—never cross-referenced against other clients’ content; and
• Is securely deleted after quality metrics have been recorded, subject to the retention period in Section 5.5.

Quality metrics derived from Benchmarking Content (e.g., structural accuracy percentages, revision category data) are classified as Aggregate Insights under Section 5.7 once the underlying content has been deleted.

5.9 Client Personal Data Protections

Client Personal Data receives the full protections required by applicable privacy law, including the GDPR, CCPA/CPRA, and TDPSA. Specifically:

• Client Personal Data is processed only as necessary for the delivery of Services or as otherwise authorized by the Client in a DPA.
• Client Personal Data is never used for the creation of Anonymized Derivatives, Aggregate Insights, or any purpose beyond service delivery without the Client’s explicit written consent.
• Client Personal Data is subject to the data subject rights described in our Privacy Policy, including rights of access, correction, deletion, portability, and objection.
• Where Notiva Labs acts as a data processor on behalf of the Client (as data controller), the specific obligations of each party shall be set forth in an executed Data Protection Agreement.
• Client Personal Data is retained only for the duration necessary to deliver the Services and is securely deleted in accordance with the applicable DPA or, in the absence of a DPA, within six (6) months of engagement completion.

5.10 Data Handling for Regulated Environments

5.11 Opt-Out Rights

You may opt out of any or all of the following by providing written notice to legal@notivalabs.com:

• Internal quality assurance use (Section 5.5);
• Creation of Anonymized Derivatives from your Client Technical Content (Section 5.6); and
• Inclusion of your engagement data in Aggregate Insights (Section 5.7).

Upon receipt of such notice, Notiva Labs will promptly cease the applicable use and delete any retained copies of your Client Content associated with that purpose. Opt-out requests do not affect the delivery of contracted Services. Clients may also establish stricter data handling requirements through an executed NDA or DPA, which shall take precedence per Section 5.3.

6. Intellectual Property

All content on the Site, including but not limited to text, graphics, logos, icons, images, software, and the overall design and arrangement thereof, is the property of Notiva Labs or its licensors and is protected by United States and international copyright, trademark, and other intellectual property laws.

The Notiva Labs name, logo, and all related names, logos, product and service names, designs, and slogans are trademarks of Notiva Labs, LLC. You may not use such marks without our prior written permission.

You may not reproduce, distribute, modify, create derivative works of, publicly display, or otherwise exploit any content on the Site without our express written consent, except as necessary for your ordinary use of the Site.

7. Deliverables

7.1 Definition of Deliverables

Unless otherwise agreed in a Service Agreement, “Deliverables” refer solely to the completed output (e.g., SOPs, process documentation) created specifically for the Client and delivered to the Client upon completion of the Services. Deliverables are provided as review-ready drafts intended for the Client’s internal review and approval; they do not constitute final, approved, or operational documents until the Client completes its own quality review and approval process.

7.2 Client Ownership of Deliverables

Upon full and final payment for the applicable Services, the Client shall own all right, title, and interest in and to the specific Deliverables created for the Client.

7.3 Limited License to Incorporated Tools

To the extent that any Deliverable incorporates Notiva Labs’ pre-existing tools, templates, or frameworks, Notiva Labs grants the Client a non-exclusive, perpetual, royalty-free, non-transferable license to use such components solely as an integrated part of the Deliverable for the Client’s internal business purposes.

8. Artificial Intelligence, Orchestration, and Proprietary IP

8.1 Nature of AI Use

Notiva Labs utilizes proprietary orchestration methodologies and third-party artificial intelligence technologies to assist in the drafting and generation of documentation. You acknowledge that our Services are a “Human-in-the-Loop” process, where AI-generated drafts are refined through Notiva Labs’ scientific review before delivery.

8.2 Deliverable Status: Review-Ready Only

AI-powered drafting is a tool to assist in the documentation process. All Deliverables are provided solely as “Review-Ready Drafts.” While Notiva Labs applies scientific review to these drafts, AI systems can produce technical inaccuracies or content that requires specific organizational context. Notiva Labs does not warrant that AI-assisted content is error-free or suitable for regulatory submission without the Client’s independent verification.

8.3 Client’s Non-Delegable Responsibility

The Client acknowledges that regulatory authorities (e.g., FDA, EMA) hold the regulated entity responsible for its documentation. You are solely responsible for:

• Performing a comprehensive internal review of all Deliverables.
• Ensuring the accuracy, completeness, and suitability of the documentation for your specific operational environment.
• The final approval and “release” of any documentation within your Quality Management System (QMS).

8.4 Notiva Labs Proprietary Intellectual Property

Notiva Labs expressly retains exclusive ownership of all right, title, and interest in and to its pre-existing and independently developed intellectual property. The Client acknowledges that the Services are delivered through a unique configuration of third-party platforms orchestrated by Notiva Labs. Notiva Labs’ proprietary IP includes but is not limited to:

• AI Methodologies: All AI prompts, prompt libraries, prompt engineering structures, and sequence logic.
• Orchestration Logic: The specific way Notiva Labs structures prompts, selects and configures AI models and parameters, coordinates data between platforms, and the logic-gating used to manage workflow across third-party services.
• Platform Configuration: Software code, algorithms, automated workflows, and the specific settings, parameters, and selection of third-party tools used in the delivery of Services.
• Know-How: All templates, scientific review frameworks, methodologies, and accumulated professional expertise used to generate Deliverables.

Client acquires no right to the prompts, orchestration methodology, or any other element of Notiva Labs’ proprietary IP, even if such elements are used to process Client Content.

8.5 Classification as Trade Secrets

The Client acknowledges and agrees that the AI prompts, engineering methodologies, orchestration sequences, and internal platform configurations described in Section 8.4 constitute the Trade Secrets of Notiva Labs, protected under the Defend Trade Secrets Act (DTSA) and the Texas Uniform Trade Secrets Act (TUTSA). These elements are strictly excluded from the definition of “Client Content” as defined in Section 5.

8.6 Audit and Inspection Limits

Any right of the Client to audit or inspect Notiva Labs for security or regulatory compliance (under an MSA or DPA) is strictly limited to the verification of data security controls. Under no circumstances shall an audit grant the Client or any third party access to Notiva Labs’ proprietary prompts, prompt engineering methodologies, or internal platform logic.

8.7 Client Data and AI Models

Notiva Labs does not use Client Content to train, fine-tune, or otherwise modify any artificial intelligence or machine learning model. Client Content is processed through secure, non-training instances of third-party platforms. For full details on the classification, handling, and permitted uses of Client Content, see Section 5.

8.8 Regulatory Disclaimer

Notiva Labs’ use of AI does not constitute the provision of “Software as a Service” (SaaS) or a “validated software system.” Our AI orchestration is an internal professional tool used to produce advisory drafts.

9. Confidentiality

Each party acknowledges that in the course of the engagement, it may receive confidential or proprietary information of the other party (“Confidential Information”). Confidential Information includes, but is not limited to, business plans, technical data, product information, trade secrets, processes, client lists, financial information, and any information marked as confidential.

Each party agrees to:

• Hold the other party’s Confidential Information in strict confidence.
• Not disclose Confidential Information to any third party without the prior written consent of the disclosing party, except to employees, contractors, or agents who need to know and are bound by confidentiality obligations at least as protective as these Terms.
• Use Confidential Information only for the purposes of performing or receiving the Services.

These confidentiality obligations do not apply to information that: (a) is or becomes publicly available through no fault of the receiving party; (b) was known to the receiving party prior to disclosure; (c) is independently developed by the receiving party without use of the disclosing party’s Confidential Information; or (d) is required to be disclosed by law, regulation, or court order, provided the receiving party gives prompt written notice to allow the disclosing party to seek protective measures.

Confidentiality obligations under this section survive termination of these Terms for a period of three (3) years.

10. Fees and Payment

Fees for our Services will be set forth in the applicable Service Agreement. Unless otherwise specified:

• All fees are quoted in U.S. dollars and are exclusive of applicable taxes.
• Payment terms are net thirty (30) days from the date of invoice unless otherwise agreed in writing.
• Late payments may be subject to interest at the lesser of 1.5% per month or the maximum rate permitted by applicable law.
• We reserve the right to suspend Services for accounts with overdue balances exceeding thirty (30) days.

You are responsible for all taxes associated with the Services, excluding taxes based on Notiva Labs’ net income.

11. Warranties and Disclaimers

11.1 Limited Service Warranty

Notiva Labs warrants that the Services will be performed in a professional and workmanlike manner consistent with generally accepted industry standards for documentation support. Because the Services consist of indirect advisory support, Notiva Labs’ sole obligation is to ensure that the Deliverables materially conform to the instructions and inputs provided by the Client.

11.2 Exclusive Remedy

If a Deliverable fails to conform to the agreed-upon SOW, your exclusive remedy is for Notiva Labs to re-perform the drafting service at no additional cost, provided you notify us in writing within thirty (30) days. Re-performance is the sole remedy available for any non-conforming drafting service.

11.3 Regulatory Disclaimer

NOTIVA LABS DOES NOT WARRANT THAT ANY DELIVERABLE WILL SATISFY THE REQUIREMENTS OF ANY SPECIFIC REGULATORY AUTHORITY (E.G., FDA, EMA, MHRA). NOTIVA LABS PROVIDES DRAFTING ASSISTANCE ONLY; THE CLIENT IS THE “PROCESS OWNER” AND “REGULATED ENTITY.” FINAL ACCURACY, SCIENTIFIC VALIDITY, AND REGULATORY COMPLIANCE ARE THE SOLE RESPONSIBILITY OF THE CLIENT.

12. Limitation of Liability

12.1 Exclusion of Certain Damages

TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, IN NO EVENT SHALL NOTIVA LABS BE LIABLE FOR ANY INDIRECT, SPECIAL, INCIDENTAL, CONSEQUENTIAL, OR PUNITIVE DAMAGES, INCLUDING BUT NOT LIMITED TO:

• REGULATORY PENALTIES: ANY FINES, WARNING LETTERS, OR INVESTIGATIVE COSTS FROM ANY GOVERNMENTAL BODY.
• BUSINESS INTERRUPTION: LOSS OF REVENUE, PROFITS, MARKET SHARE, OR COSTS RESULTING FROM PRODUCT LAUNCH DELAYS.
• REMEDIATION: COSTS ASSOCIATED WITH PRODUCT RECALLS, FACILITY SHUTDOWNS, OR CORRECTIVE ACTIONS.
• EXTERNAL FAILURES: DATA BREACHES OR INTERRUPTIONS ORIGINATING FROM THIRD-PARTY AI PLATFORMS OUTSIDE OF NOTIVA LABS’ DIRECT CONTROL.

12.2 Total Aggregate Cap

Notiva Labs’ total aggregate liability for any and all claims arising out of this Agreement—whether in contract, tort, or otherwise—shall not exceed the total fees paid by the Client to Notiva Labs for the specific Statement of Work (SOW) giving rise to the claim during the twelve (12) months preceding the event.

Some jurisdictions do not allow the exclusion or limitation of certain damages. In such jurisdictions, our liability shall be limited to the greatest extent permitted by law.

13. Indemnification

13.1 Client Indemnification

Client shall indemnify, defend (at Notiva Labs’ request), and hold harmless Notiva Labs and its officers, directors, and agents from and against any third-party claims, liabilities, damages, or expenses (including reasonable attorneys’ fees) arising out of or related to:

• Regulatory Action: Any claim, fine, or investigation by a regulatory authority resulting from the Client’s implementation or use of a Deliverable.
• Product Liability: Any claim that a product manufactured, released, or sold under documentation drafted by Notiva Labs caused harm, injury, or death.
• Validation Failure: Any loss resulting from the Client’s failure to perform adequate internal technical review, validation, or training prior to using a Deliverable in a regulated environment.

14. Termination

Either party may terminate a Service Agreement as specified therein. We may suspend or terminate your access to the Site at any time for violation of these Terms, with or without notice.

Upon termination of any engagement:

• You shall pay all fees owed for Services performed through the date of termination.
• Each party shall return or destroy the other party’s Confidential Information upon request.
• Sections that by their nature should survive termination shall survive, including but not limited to: Section 6 (Intellectual Property), Section 7 (Deliverables), Section 8 (AI, Orchestration, and Proprietary IP), Section 9 (Confidentiality), Section 12 (Limitation of Liability), and Section 13 (Indemnification).

15. Governing Law and Dispute Resolution

These Terms shall be governed by and construed in accordance with the laws of the State of Texas, without regard to its conflict of law principles. Any disputes arising out of or relating to these Terms or the Services shall be resolved as follows:

• Negotiation: The parties shall first attempt to resolve any dispute through good-faith negotiation for a period of thirty (30) days from written notice of the dispute.
• Mediation: If the dispute is not resolved through negotiation, the parties agree to attempt mediation administered by a mutually agreed-upon mediator in Austin, Texas, before pursuing other remedies.
• Litigation: If mediation is unsuccessful, any legal action shall be brought exclusively in the state or federal courts located in Travis County, Texas, and you consent to the personal jurisdiction of such courts.
• Attorneys’ Fees: In any legal action or arbitration brought to enforce or interpret these Terms, the prevailing party shall be entitled to recover its reasonable attorneys’ fees and costs from the non-prevailing party.

EACH PARTY HEREBY IRREVOCABLY WAIVES, TO THE FULLEST EXTENT PERMITTED BY LAW, ANY RIGHT TO A TRIAL BY JURY IN ANY LEGAL PROCEEDING ARISING OUT OF THESE TERMS.

16. Force Majeure

Neither party shall be liable for any failure or delay in performing its obligations under these Terms where such failure or delay results from circumstances beyond the reasonable control of that party, including but not limited to natural disasters, acts of war or terrorism, pandemics, government actions, power failures, internet or telecommunications outages, third-party AI platform or cloud service provider outages, algorithmic shifts by third-party providers, or cyberattacks. The affected party shall give prompt notice and use reasonable efforts to mitigate the impact.

17. Third-Party Links and Services

The Site may contain links to third-party websites or services. We do not control and are not responsible for the content, privacy policies, or practices of any third-party sites or services. Your use of third-party sites is at your own risk, and we encourage you to review the applicable terms and privacy policies of any sites you visit.

18. Modifications to These Terms

We reserve the right to modify these Terms at any time. When we make material changes, we will update the “Last Updated” date at the top of this page and, where required by law, provide notice of the changes. Your continued use of the Site or Services after the effective date of any modifications constitutes your acceptance of the revised Terms. If you do not agree to the revised Terms, you must stop using the Site and Services.

19. Severability

If any provision of these Terms is held to be invalid, illegal, or unenforceable by a court of competent jurisdiction, such provision shall be modified to the minimum extent necessary to make it enforceable, or if modification is not possible, severed from these Terms. The remaining provisions shall continue in full force and effect.

20. Entire Agreement

These Terms, together with our Privacy Policy and any applicable Service Agreements, constitute the entire agreement between you and Notiva Labs with respect to the subject matter hereof and supersede all prior or contemporaneous communications, understandings, and agreements, whether oral or written. No waiver of any provision of these Terms shall be deemed a further or continuing waiver of such provision or any other provision.

21. Contact Us

If you have any questions about these Terms of Service, please contact us: