Terms and Conditions

Agreement to Terms

These Terms & Conditions constitute a legally binding agreement between you, whether individually or on behalf of an organization ("you" or "your"), and GMPKit, LLC ("GMPKit," "Company," "we," "us," or "our") governing your access to and use of GMPKit websites, software, and services, including GMPWit™ and related offerings available through gmpkit.com, ai.gmpkit.com, and associated websites and applications (collectively, the "Services").

GMPWit is an AI-enabled workspace designed to support Good Manufacturing Practice (GMP) professionals through learning, guided problem-solving, analysis, documentation development, and other structured workflows. GMPWit includes Learn and Create functionality and may provide AI-assisted responses, recommendations, analyses, and draft documentation.

By accessing or using the Services, or affirmatively accepting these Terms where prompted, you agree to be bound by them. If you do not agree, you must not access or use the Services.

The Services are intended for individuals who are at least 18 years of age.

Intellectual Property Rights

Except as otherwise expressly provided, GMPKit and its licensors retain all rights, title, and interest in the Services, including underlying software, source code, designs, proprietary workflows, methodologies, system instructions, training materials, GMPKit Field Guide content, trademarks, and other intellectual property.

Subject to compliance with these Terms and any applicable subscription or customer agreement, GMPKit grants authorized users a limited, non-exclusive, non-transferable right to access and use the Services for their legitimate professional, organizational, or business purposes.

Access to GMPWit does not transfer ownership of GMPKit's underlying technology, proprietary methods, workflows, software, or other intellectual property to the user or customer.

Customer-supplied content and AI-generated outputs are addressed separately under the Customer Content and Generated Outputs provisions of these Terms.

AI-Assisted Services and Professional Responsibility

GMPWit is designed to assist qualified professionals with learning, analysis, structured problem-solving, and preparation of documentation. It supports, but does not replace, professional judgment, organizational decision-making, or established quality and regulatory processes.

GMPWit currently generates AI-assisted outputs through commercial AI model services provided by Anthropic. GMPKit may engage additional or different AI service providers in the future, subject to applicable contractual, confidentiality, and data protection requirements.

Users and their organizations remain responsible for reviewing and evaluating GMPWit-generated content, determining its suitability for the intended purpose, and completing any required verification, review, approval, or other governed activities before relying on such content in regulated operations.

Generated Outputs must not be used as the basis for a decision about a specific individual—including a decision concerning an individual's hiring, employment, performance evaluation, discipline, suspension, termination, qualification, or certification—unless a qualified person with the authority to change the outcome has meaningfully reviewed the output before the decision is made or communicated, and the individual who is the subject of the decision is clearly informed that AI was used. The customer is responsible for implementing these controls and for complying with any additional requirements of applicable law.

GMPWit is not the authoritative System of Record and does not replace an organization's required quality management, manufacturing execution, laboratory information management, document control, or other governed systems.

Content generated through GMPWit does not automatically constitute an approved GMP record or establish that an investigation, assessment, validation activity, or other regulated process has been completed.

Use of GMPWit does not transfer responsibility for GMP compliance, regulatory decisions, product quality, or organizational approvals from the user or their organization to GMPKit.

Customer Content

In connection with use of GMPWit and other applicable Services, users may submit or upload information, documents, prompts, conversations, procedures, operational data, technical information, supporting evidence, and other materials (collectively, "Customer Content").

Customer Content may include confidential or proprietary business information, including information relating to manufacturing operations, quality systems, investigations, processes, and regulated activities.

As between GMPKit and the customer, the customer retains all rights, title, and interest it possesses in Customer Content. Submission of Customer Content does not transfer ownership of that content to GMPKit.

The customer grants GMPKit a limited, non-exclusive right to access, process, transmit, store, and otherwise use Customer Content solely as reasonably necessary to provide, maintain, secure, support, and operate the Services, fulfill applicable contractual obligations, and comply with applicable law.

This license does not permit GMPKit to use Customer Content to train or fine-tune artificial intelligence models, and GMPKit does not submit Customer Content to its service providers for that purpose. Processing Customer Content to generate the responses and outputs requested by users is not model training.

Users are responsible for ensuring they have the necessary rights and authorizations to submit Customer Content to the Services, including information owned or controlled by their employers, customers, or other third parties.

Nothing in these Terms grants GMPKit ownership of Customer Content or permits its unrelated commercial exploitation.

Feedback

Users may provide comments, ratings, suggestions, or other feedback concerning the Services ("Feedback"). GMPKit may use Feedback to operate, support, and improve the Services.

GMPKit does not use Feedback to train or fine-tune AI models and does not submit Feedback to its AI service providers or other service providers for that purpose. Where Feedback includes or references Customer Content, that Customer Content remains subject to these Terms.

Generated Outputs

GMPWit may produce AI-assisted responses, analyses, recommendations, structured information, proposed language, draft documents, and other materials in response to Customer Content and user interactions (collectively, "Generated Outputs").

Subject to these Terms and any applicable customer agreement, customers may use, reproduce, modify, incorporate, and distribute Generated Outputs for their legitimate internal business, professional, quality, operational, and regulatory purposes.

GMPKit does not claim ownership of a customer's independently supplied information or restrict a customer's legitimate use of Generated Outputs solely because those outputs were produced through GMPWit.

Generated Outputs may incorporate general concepts, structures, methodologies, or other elements associated with GMPKit's proprietary technology. Nothing in these Terms transfers ownership of GMPKit's underlying software, proprietary workflows, system instructions, methodologies, or other protected intellectual property.

Due to the nature of AI-assisted technologies, similar or substantially similar outputs may be generated for different users. GMPKit does not represent that Generated Outputs are necessarily unique or eligible for intellectual property protection.

Generated Outputs remain subject to the professional review, verification, approval, and governed-system requirements described elsewhere in these Terms.

Confidentiality of Customer Information

GMPKit recognizes that Customer Content submitted through GMPWit may contain confidential, proprietary, or commercially sensitive information, including technical processes, manufacturing information, quality-system documentation, investigation materials, trade secrets, and other nonpublic business information.

GMPKit will treat such information as confidential and will not disclose it to third parties except as reasonably necessary to provide, maintain, secure, or support the Services; through authorized service providers acting on GMPKit's behalf, including the AI model, application backend and hosting, and document-processing providers described in the Privacy Notice, subject to appropriate confidentiality obligations; as authorized by the customer; or as required by applicable law.

GMPKit will use reasonable administrative, technical, and organizational safeguards designed to protect Customer Content against unauthorized access, use, or disclosure.

GMPKit restricts access to Customer Content to authorized personnel and service providers who require access for the purposes described in these Terms and the Privacy Notice, and limits operational logging of Customer Content as described in the Privacy Notice.

Confidentiality obligations do not apply to information that becomes publicly available without a breach of these Terms, was lawfully known to GMPKit without a confidentiality obligation, is independently developed without use of the customer's confidential information, or is lawfully received from another source without restriction.

Nothing in this section limits additional confidentiality protections established under an applicable nondisclosure agreement, master services agreement, data processing agreement, or other written agreement between GMPKit and the customer.

User Registration

Access to certain Services may require registration or creation of an individual user account. Users must provide accurate account information and maintain the confidentiality and security of their login credentials.

Accounts and credentials are assigned to authorized users and may not be shared or transferred without GMPKit's authorization. Users are responsible for activity conducted through their accounts, except to the extent resulting from circumstances for which they are not responsible under applicable law.

Users must promptly notify GMPKit of suspected unauthorized account access or security incidents affecting their credentials.

Where access is provided through an organization, the user must comply with applicable organizational policies and authorization requirements.

GMPKit may suspend, restrict, or revoke account access when reasonably necessary to address security concerns, unauthorized activity, violations of these Terms, or other legitimate operational requirements.

Fees and Payment

Certain Services require payment of subscription fees or other applicable charges. Pricing, subscription terms, billing frequency, and any applicable usage limitations will be communicated at the time of purchase or established in a separate written agreement.

Customers agree to provide accurate and current billing information and authorize GMPKit or its designated payment processor to charge applicable fees and taxes in accordance with the selected subscription or agreement.

For automatically renewing subscriptions, customers authorize recurring charges at the disclosed billing frequency until the subscription is canceled in accordance with the applicable cancellation terms.

GMPKit may modify subscription pricing prospectively, subject to applicable notice requirements and the terms of any existing subscription or written agreement. Changes will not retroactively increase fees already paid for a current subscription term.

Unless otherwise specified in an applicable written agreement or purchase terms, payments are made in United States dollars.

GMPWit subscriptions provide access to the features and functionality included in the purchased subscription offering. Separately contracted enterprise services, custom integrations, or other professional services may be subject to additional terms and fees.

Payment Failure

If payment for a subscription is unsuccessful or overdue, GMPKit may suspend or restrict access to the applicable subscription, subject to the subscription terms, applicable notices, and applicable law.

Any applicable payment recovery procedures, grace periods, and consequences of continued nonpayment will be governed by the subscription terms communicated to the customer.

Suspension or termination of access does not, by itself, establish that stored Customer Content will be immediately or permanently deleted. Data handling following suspension or termination is addressed separately in these Terms and the applicable Privacy Notice.

Cancellation

Customers may cancel recurring subscriptions through the cancellation mechanisms made available for the applicable Service or by contacting GMPKit at support@gmpkit.com.

Unless otherwise stated in the applicable subscription or written agreement, cancellation will take effect at the end of the current paid subscription period, and access to paid subscription features will continue until that period expires, subject to these Terms.

Fees already paid are generally non-refundable except where otherwise expressly provided in the applicable purchase terms, required by law, or agreed to in writing by GMPKit.

Cancellation does not automatically establish immediate deletion of Customer Content. Data retention and deletion following cancellation are addressed separately in these Terms, including the Customer Working Content Retention section below, and the applicable Privacy Notice.

Customer Working Content Retention

This section describes GMPKit's standard retention practices for Customer working content maintained through GMPWit. Applicable written customer agreements and legal obligations may establish different or supplementary retention requirements.

For purposes of this section, "Customer working content" means uploads, extracted text, conversations, generated outputs, and other materials associated with a user's Documents and Coach Sessions maintained through GMPWit, including all copies retained within the application.

Standard Retention Period

Customer working content has a standard retention period of thirty (30) days following the last substantive user interaction with that content. Substantive activity includes uploading information, adding or editing content, or submitting coaching information that materially engages with the content. Merely viewing content, logging in, or opening a page does not reset the retention period.

Each Document and each Coach Session maintains its own retention period based on substantive activity within that item. Accessing one item does not automatically extend the retention period of other linked or associated items. However, the effective expiration of a linked Coach Session may be influenced by the retention protection of the associated Document where the Document's retention extends beyond the Coach Session's standard expiration date. Customers should consult the GMPWit Dashboard for the current expiration status of each Document and Coach Session.

Self-Service Extension

Each eligible Document and each eligible Coach Session has an independent one-time self-service extension allowance available within GMPWit. The user must affirmatively confirm each extension; confirmation is required and creates an audit record. Utilizing an extension for one Document does not affect the extension allowance available to any other Document or Coach Session.

For unexpired content, the extension adds thirty (30) days to the content's existing effective expiration date.

One self-service extension is available per eligible item. Additional retention terms may be available under separately negotiated written agreements with GMPKit.

Dashboard Visibility and Expiration

Expiration dates for Customer working content are visible on the GMPWit Dashboard. Customers are responsible for monitoring content expiration dates and taking appropriate action before content reaches its expiration date, including utilizing the self-service extension mechanism described above or exporting required information to their own governed systems.

Expiration status is provided only within GMPWit, including on the GMPWit Dashboard. GMPKit does not send expiration notices by email or through other channels outside GMPWit, and customers should not expect to receive notice outside the application before content expires.

Content may remain accessible within GMPWit beyond its standard expiration date. Customers should not rely on continued content availability as confirmation that the content will be preserved indefinitely.

Deletion

At the end of the applicable retention period, including any authorized extension, Customer working content becomes eligible for automated deletion from GMPWit's application records. Deletion is performed through automated processes and may not occur immediately upon expiration. Expired content may therefore remain in application records, and may remain accessible, for a period after its expiration date. Customers should not rely on that period.

Deletion from GMPWit's application records does not immediately remove copies that may exist in infrastructure backups, disaster-recovery systems, or logs maintained by GMPKit's hosting and infrastructure providers. Such copies are not subject to the standard working-content retention period. They are retained and removed in accordance with those providers' systems and GMPKit's arrangements with them, which may be subject to limitations. GMPKit does not represent a specific period within which such copies are removed.

Customers are responsible for exporting or maintaining copies of any required information within their own governed systems before Customer working content reaches its expiration date. Use of GMPWit does not replace an organization's responsibility to maintain required official GMP records in its authorized systems of record.

Service Provider Processing and Retention

Customer Content may be processed by GMPKit's service providers to provide the Services, including GMPWit's AI model provider (currently Anthropic), GMPKit's application backend and hosting provider, and the document-parsing service used to extract text from uploaded files, as described in the Privacy Notice. Information processed by these providers is subject to their applicable data-retention and data-handling practices and to GMPKit's arrangements with them. Those practices and arrangements may permit retention for purposes such as service delivery, security, abuse prevention, and legal compliance. Provider-side retention parameters are determined by those arrangements and not by GMPWit's application retention settings.

Provider-side retention is distinct from, and does not determine, the retention of Customer working content maintained in GMPWit's application records. Expiration or deletion of content within GMPWit does not, by itself, cause deletion by a service provider. Provider-side processing to generate responses does not, by itself, constitute model training on Customer Content.

Separately Governed Records

Retention of records maintained for legal compliance, security operations, financial administration, and audit purposes may be subject to separately applicable legal or regulatory requirements, contractual obligations, or GMPKit's operational policies. Such records may be retained beyond the standard working-content retention period as required or permitted by applicable law and GMPKit's operational requirements.

When Customer working content is deleted, GMPKit retains certain sanitized audit records and related operational information, such as internal identifiers, timestamps, and records of extension confirmations, expiration, and deletion events. These records are maintained for audit, security, and operational purposes and are not subject to the standard working-content retention period.

Acceptable Use Policy

Users may access and use the Services only for lawful, authorized purposes consistent with these Terms and the intended functionality of the applicable Service.

Users agree not to:

• Access or attempt to access accounts, systems, information, or Services without authorization.
• Circumvent, disable, interfere with, or attempt to bypass security features, access restrictions, or technical safeguards.
• Reverse engineer, decompile, disassemble, or otherwise attempt to obtain protected source code or proprietary system instructions except as expressly permitted by applicable law.
• Introduce malicious code, disrupt service operations, or interfere with the security or availability of the Services.
• Use the Services to unlawfully obtain, disclose, or process confidential, proprietary, personal, or third-party information.
• Submit Controlled Unclassified Information, export-controlled information, or other specially regulated information to GMPWit without applicable authorization and established controls under a written agreement with GMPKit.
• Submit protected health information as defined under the U.S. Health Insurance Portability and Accountability Act ("HIPAA"), or other health information relating to identifiable patients or clinical-trial subjects, to GMPWit. Users must remove patient and subject identifiers from complaint, adverse-event, deviation, investigation, and similar materials before submission.
• Use GMPWit in a manner that would violate the usage policies of GMPKit's AI model provider applicable to the Services, including Anthropic's Usage Policy, as updated from time to time.
• Access or use GMPWit from a country or region in which GMPKit's AI model provider does not support access to its services, or on behalf of an entity incorporated or headquartered in, or majority-owned or controlled by persons or entities located in, such a country or region.
• Attempt to bypass or interfere with safeguards or restrictions of GMPWit or its underlying AI models, including through jailbreaking or prompt-injection techniques.
• Use outputs generated by GMPWit's AI features to train an AI model, including through model scraping or model distillation, except as permitted under the applicable AI model provider's policies.
• Connect GMPWit or Generated Outputs to equipment, process-control, automation, or other systems in a manner that causes outputs to be acted upon without prior review and approval by a qualified person.
• Use GMPWit to knowingly fabricate, falsify, or misrepresent regulated records, supporting evidence, investigation findings, testing results, or other GMP documentation.
• Intentionally represent invented, unsupported, or unverified information as established fact in regulated documentation.
• Misrepresent planned or incomplete regulated activities as completed activities.
• Use the Services for fraudulent, deceptive, unlawful, or otherwise unauthorized purposes.
• Reproduce, resell, sublicense, or commercially exploit GMPKit software, proprietary workflows, underlying technology, or protected intellectual property without authorization.
• Use the Services in violation of applicable laws, regulations, contractual obligations, or the rights of others.

GMPWit is not designed or intended to create, receive, maintain, or transmit protected health information. These Terms do not establish a business associate relationship under HIPAA, and nothing in these Terms or the Services represents that GMPWit is HIPAA compliant, certified, or approved for processing protected health information.

Authorized professional, organizational, and commercial use of GMPWit is permitted in accordance with the applicable subscription or customer agreement.

Nothing in this Acceptable Use Policy prohibits legitimate use of GMPWit to support GMP learning, investigations, structured analysis, documentation preparation, or other authorized regulated-business activities, subject to appropriate human review and organizational governance.

Term and Termination

These Terms remain effective while a user accesses or uses the Services, unless terminated in accordance with their provisions or an applicable written agreement.

GMPKit may suspend or terminate access when reasonably necessary because of material violations of these Terms, unauthorized use, security concerns, legal requirements, requirements of GMPKit's AI service providers, nonpayment, or other circumstances that materially affect the lawful or secure operation of the Services.

Where reasonably practicable and appropriate under the circumstances, GMPKit may provide notice and an opportunity to address the issue before termination. Immediate suspension may be necessary to protect users, Customer Content, system security, or the integrity of the Services.

Upon termination or expiration of a subscription, the customer's right to access the applicable paid Services may cease, subject to any surviving contractual rights or applicable legal requirements.

Termination does not eliminate payment obligations incurred before termination or provisions that by their nature are intended to survive, including intellectual property protections, applicable confidentiality obligations, limitations of liability, and dispute-resolution provisions.

Customer Data Following Cancellation or Termination

Following cancellation, expiration, suspension, or termination of a subscription, access to Customer Content, stored conversations, uploaded documents, generated outputs, or other information maintained through the Services may be restricted or discontinued.

The retention, deletion, or continued availability of Customer working content is governed by the Customer Working Content Retention section of these Terms. Retention of other information is governed by GMPKit's Privacy Notice, applicable customer agreements, and legal obligations.

Data-retention practices of third-party service providers, including GMPWit's AI model provider, application hosting provider, and document-parsing service, are distinct from GMPWit's own application data retention and are described in the applicable Privacy Notice and the Customer Working Content Retention section of these Terms.

GMPKit may retain information where reasonably necessary to comply with applicable law, maintain security, prevent fraud, resolve disputes, enforce agreements, or satisfy other legitimate legal obligations, subject to applicable data protection requirements.

Customers are responsible for maintaining copies of information they are required to preserve within their own governed systems, including applicable GMP records and approved documentation.

Use of GMPWit does not replace a customer's responsibility to maintain required official records or satisfy applicable record-retention obligations.

These Terms do not establish a guaranteed post-termination access period, export capability, or deletion deadline unless expressly stated in an applicable agreement or service-specific policy. For the standard retention period applicable to Customer working content during and following a subscription, see the Customer Working Content Retention section of these Terms.

Customers are responsible for exporting required information from GMPWit before or upon cancellation or termination. GMPKit is not obligated to provide ongoing access to Customer Content following the termination of an applicable subscription or written agreement.

Governing Law

These Terms & Conditions and your use of the Services are governed by and construed in accordance with the laws of the State of Washington applicable to agreements made and to be entirely performed within the State of Washington, without regard to its conflict of law principles.

Dispute Resolution

Informal Negotiations

To expedite resolution and control the cost of any dispute, claim, or controversy arising out of or relating to these Terms or the Services (a "Dispute"), you and GMPKit (collectively, the "Parties") agree to first attempt to negotiate any Dispute informally for at least thirty (30) days before initiating arbitration.

Binding Arbitration

If the Parties are unable to resolve a Dispute through informal negotiations, the Dispute shall be exclusively resolved through binding arbitration. YOU UNDERSTAND THAT WITHOUT THIS PROVISION, YOU WOULD HAVE THE RIGHT TO FILE A LAWSUIT IN COURT AND HAVE A JURY TRIAL.

The arbitration shall be administered by the American Arbitration Association ("AAA") in accordance with its Commercial Arbitration Rules. Except where otherwise required by AAA rules or applicable law, the arbitration shall take place in the State of Washington, United States.

Disclaimer

Limitations of Liability

Enterprise and Customer-Specific Agreements

Certain GMPKit Services, including enterprise GMPWit offerings, may be provided under separately executed master services agreements, statements of work, data processing agreements, nondisclosure agreements, or other written customer-specific agreements.

Where a separately executed written agreement expressly governs a Service and conflicts with these Terms, the applicable provisions of that written agreement will control to the extent of the conflict.

Provisions of these Terms that do not conflict with the applicable written agreement remain effective unless otherwise provided in that agreement.

Changes to Terms & Conditions

GMPKit may update these Terms from time to time to reflect changes in Services, applicable requirements, business practices, or other legitimate operational considerations.

Updated Terms will identify an effective date and may include a document version or other reference identifying the applicable revision.

Where required by applicable law or appropriate because of the nature of a material change, GMPKit will provide notice and may require affirmative acceptance of updated Terms before continued access to applicable Services.

Continued use of the Services following an update will have the effect permitted by applicable law and the applicable notice or acceptance process.

GMPKit may retain records of user acceptance, including the applicable Terms version, date and time of acceptance, and related information as described in the Privacy Notice.

Revision History

Contact Us

In order to resolve a complaint regarding the Services or to receive further information regarding use of the Services, please contact us at: