Terms of Service

Version 1.1 — Effective Date: March 21, 2026

These Terms of Service (“Terms”) govern your access to and use of the websites, mobile applications, dashboards, software, kits, tests, reports, conversational AI features, research tools, partner portals, and related services made available by ANI BIOME PBC, together with its current and future direct and indirect parents, subsidiaries, affiliates, successors, assigns, and other related entities, including Cidrani d.o.o. (collectively, “Ani,” “ANI,” “we,” “us,” or “our”).

For purposes of these Terms, “Services” includes, as applicable, the Ani.ai platform, Ani Digital Platform, ANI Medical and related clinical, provider, research, or operational dashboards (the “ANI Medical Product Suite”), Talk to Ani and other conversational or AI-enabled features, Ani Labs tests, sample collection kits, reports, Vitalligence Scores, partner services, internal research programs, clinical trial activities, research-grade analysis services, and any related food products, supplements, nutritional products, content, software, or functionality we make available in connection with those services. The terms “Ani.ai,” “Ani,” and “ANI” may be used interchangeably in these Terms, as the context requires.

PLEASE READ THESE TERMS CAREFULLY. BY ACCESSING, USING, REGISTERING FOR, ENROLLING IN, OR OTHERWISE PARTICIPATING IN THE SERVICES, YOU AGREE TO BE BOUND BY THESE TERMS, OUR PRIVACY POLICY, AND ANY ADDITIONAL CONSENTS, DISCLOSURES, OR PROGRAM-SPECIFIC TERMS THAT APPLY TO THE SERVICES YOU USE. IF YOU DO NOT AGREE, DO NOT USE THE SERVICES.

Important Notices

• ANI’S SERVICES ARE PROVIDED FOR RESEARCH, INFORMATIONAL, EDUCATIONAL, OPERATIONAL, WELLNESS, AND PRODUCT DEVELOPMENT PURPOSES ONLY, EXCEPT TO THE LIMITED EXTENT THAT LICENSED THIRD-PARTY PROVIDERS OR PARTNERS SEPARATELY PROVIDE CLINICAL SERVICES TO YOU.
• ANI IS NOT A HOSPITAL, PHYSICIAN PRACTICE, PHARMACY, OR EMERGENCY RESPONSE PROVIDER, AND ANI DOES NOT PRACTICE MEDICINE OR PROVIDE MEDICAL ADVICE, DIAGNOSIS, OR TREATMENT.
• ANI MEDICAL TOOLS MAY FACILITATE COMMUNICATIONS, DATA REVIEW, WORKFLOWS, AND CLINICAL OPERATIONS, BUT THEY DO NOT REPLACE THE PROFESSIONAL JUDGMENT OF LICENSED HEALTHCARE PROVIDERS.
• UNLESS A SPECIFIC ANI SERVICE OR PROGRAM EXPRESSLY STATES OTHERWISE IN OFFICIAL DOCUMENTATION, NO ANI TEST, KIT, REPORT, SCORE, DASHBOARD, SOFTWARE FEATURE, AI FEATURE, FOOD PRODUCT, SUPPLEMENT, NUTRITIONAL PRODUCT, OR OTHER SERVICE IS INTENDED FOR DIAGNOSTIC OR THERAPEUTIC USE, OR TO DIAGNOSE, CURE, MITIGATE, TREAT, OR PREVENT ANY DISEASE.
• DO NOT USE THE SERVICES FOR EMERGENCY NEEDS. IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY, CALL 911 OR CONTACT LOCAL EMERGENCY SERVICES IMMEDIATELY.
• THESE TERMS CONTAIN A DISPUTE RESOLUTION AND ARBITRATION PROVISION, INCLUDING A CLASS ACTION WAIVER, IN SECTION 20.

1. Acceptance, Scope, and Order of Precedence

1.1. These Terms apply to all users of the Services, including individual users, research participants, caregivers, authorized representatives, healthcare providers, clinics, research institutions, enterprise users, and other organizations or persons who access or use the Services.

1.2. Certain Services may be subject to additional terms, informed consent forms, authorizations, notices, study documents, provider agreements, partner agreements, fee schedules, or program-specific policies. If there is a conflict between these Terms and a study-specific informed consent form, provider agreement, enterprise agreement, or other service-specific agreement, the more specific document will control solely for that specific Service or activity.

1.3. If you are using the Services on behalf of another person, you represent and warrant that you are authorized to act for that person and to bind that person to these Terms. If you are using the Services on behalf of an entity, clinic, research site, or other organization, you represent and warrant that you have authority to bind that organization.

1.4. We may revise these Terms from time to time. Updated Terms will become effective on the date stated in the revised Terms or when otherwise communicated to you. Your continued use of the Services after the effective date of the updated Terms constitutes acceptance of the revised Terms.

2. Eligibility and Accounts

2.1. You must be at least 18 years old, or the age of legal majority where you live, to create an account or use the Services unless we expressly allow use by a minor through a parent, guardian, healthcare provider, or research site and all required consents have been validly obtained.

2.2. You may be required to create an account and provide registration, contact, shipping, questionnaire, study, provider, or other information. You agree to provide accurate, current, and complete information and to keep it updated.

2.3. You are responsible for safeguarding your account credentials and for all activity under your account. You must promptly notify us of any suspected unauthorized use of your account or any security incident involving the Services.

2.4. We may refuse registration, suspend an account, require identity verification, require additional onboarding, or limit access to some or all Services where reasonably necessary for safety, compliance, fraud prevention, platform integrity, or legal reasons.

2.5. You may only create and use one account for yourself unless we expressly permit otherwise. Shared credentials, impersonation, and unauthorized account transfers are prohibited.

3. Nature, Availability, and Changes to the Services

3.1. The Services may include:

• collection, shipment, testing, handling, storage, analysis, and processing of biological samples such as stool, blood, saliva, tongue swabs, cheek swabs, skin swabs, and other materials;
• collection of questionnaires, self-reported data, device or sensor data, images, messages, voice inputs, and other digital information;
• generation of sample data, test data, reports, scores, recommendations, insights, analytics, and other outputs using software, analytics, artificial intelligence, and statistical models;
• access to the ANI Medical Product Suite, including dashboards, portals, administrative tools, workflow tools, research tools, and provider-facing tools;
• research-grade analysis services, educational content, participant support services, and related food products, supplements, or nutritional products that may be provided through a research program, partner clinic program, or other Ani service;
• conversational AI features such as Talk to Ani; and
• participation in Ani-led studies, partner-led studies, optional research programs, product development activities, and related initiatives.

3.2. Availability of particular Services may vary by geography, age, service type, regulatory status, study criteria, provider participation, partner availability, logistics constraints, and other factors. We may modify, suspend, or discontinue any Service, feature, tool, or program at any time.

3.3. Some Services may require provider authorization, research-site authorization, enterprise onboarding, study enrollment, or other third-party approval before use. We do not guarantee that every requested Service will be available to every user.

3.4. We may add or remove features, functionality, content, integrations, tools, or service lines from time to time. We may also release beta, pilot, experimental, or limited-availability features, and those features may be unavailable, changed, or discontinued at any time.

3.5. Access to some Services may depend on compatible devices, internet access, third-party platforms, or app stores. You are responsible for all carrier, device, data, and internet charges that may apply to your use of the Services.

4. Not Medical Advice; No Emergency Use

4.1. Except to the limited extent that a licensed third-party provider separately offers clinical services through or in connection with the Services, Ani does not provide medical advice, diagnosis, treatment, pharmacy services, or emergency care.

4.2. Reports, scores, outputs, recommendations, AI responses, educational content, support communications, and related materials are not a substitute for professional medical advice, diagnosis, treatment, crisis care, or clinical judgment. You should always seek the advice of a qualified healthcare professional regarding any medical concern or before making health-related decisions.

4.3. Ani Medical and other provider-facing tools are administrative, analytic, communication, research, and operational tools. They are not intended to direct clinical care independently and do not replace a provider’s professional judgment, licensure obligations, charting obligations, supervision duties, triage duties, or duty to respond to emergencies.

4.4. Do not use the Services to report urgent symptoms or obtain emergency assistance. If you believe you are experiencing a medical emergency, call 911 or your local emergency services immediately.

4.5. Unless a specific Ani Service expressly states otherwise in applicable official written documentation, Ani’s Services, including any related food products, supplements, or nutritional products provided through the Services, have not been cleared, approved, or authorized by the U.S. Food and Drug Administration as diagnostic or therapeutic products, medical devices, or clinical decision tools.

5. ANI Medical, Providers, Authorizations, and Partner Services

5.1. If you are a healthcare provider, clinic, research site, employer, enterprise customer, or other organization using the ANI Medical Product Suite or related Services (“Provider User”), you are solely responsible for:

• obtaining all authorizations, notices, and consents required to submit, access, review, disclose, or use patient, participant, or user information;
• complying with all professional, ethical, legal, regulatory, privacy, security, medical record, and billing requirements applicable to your activities;
• verifying the identity of any patient, participant, or authorized representative before disclosing or acting on information;
• reviewing dashboards, alerts, reports, messages, and results in a timely manner and maintaining appropriate backup procedures;
• making all diagnosis, treatment, prescribing, referral, escalation, and follow-up decisions; and
• ensuring that the Services are not relied upon as the sole means of monitoring emergencies or time-sensitive clinical conditions.

5.2. Ani does not employ, supervise, control, or direct the professional judgment of independent providers, research sites, clinics, or other partners unless expressly stated in a separate written agreement.

5.3. Use of the Services does not, by itself, create a provider-patient relationship between you and Ani. Any provider-patient, site-participant, or clinic-patient relationship exists only between the applicable licensed provider, clinic, or institution and the relevant individual.

5.4. Some tests, services, or workflows may require a provider order, site authorization, or partner approval under applicable law or protocol. You authorize Ani to share relevant information with authorized providers, laboratories, research sites, oversight partners, logistics partners, and similar service providers as reasonably necessary to fulfill the requested Service and as described in the Privacy Policy and applicable consent materials.

5.5. Ani may facilitate communications, scheduling, administrative support, logistics, data handling, or technology support for independent providers or partners, but Ani is not responsible for independent clinical decisions, prescriptions, diagnoses, treatment plans, or follow-up care provided by independent third parties.

6. Kits, Samples, Testing, Results, and Service Access

6.1. If you receive or use a sample collection kit or testing service, you must follow all kit instructions, sample handling instructions, shipping instructions, and stated submission timelines. Failure to follow instructions may result in sample rejection, invalid results, processing delay, or inability to complete the Service.

6.2. Some Services require you to scan, register, or otherwise correctly associate the barcode, kit ID, or other unique identifier on your sample kit, sample tube, or sample container with your account or the intended user before submission. If you do not accurately scan or register the barcode or identifier, or if the barcode or identifier is missing, damaged, unreadable, incomplete, mismatched, or otherwise cannot be matched to the correct user, Ani may be unable to identify the owner of the sample and may be unable to analyze, process, report on, or otherwise provide any Service for that sample. In those cases, the sample may be rejected, canceled, or destroyed without liability to Ani.

6.3. By submitting a sample, you represent that the sample is lawfully provided, that you are authorized to submit it, and that any information you provide in connection with the sample is accurate to the best of your knowledge.

6.4. Unless otherwise stated in the applicable kit instructions, sample submission policy, service documentation, or study materials, samples should be submitted within the time period specified for that service or program. Ani may decline to process stale, degraded, late, unsafe, or otherwise non-compliant samples.

6.5. Samples are processed in ways that are generally irreversible. Unless required by law or expressly stated otherwise, submitted samples cannot be returned.

6.6. Testing and analysis may be performed by Ani, its affiliates, certified or licensed partner laboratories, sequencing facilities, or other authorized service providers. Ani may use third-party logistics carriers and other vendors to provide related operational support.

6.7. Sample failure, invalidation, insufficiency, contamination, temperature issues, shipping damage, delayed return, incomplete collection, barcode mismatches, failed registration, or other quality-control issues may require retesting or a replacement sample. Ani may, but is not obligated to, offer a replacement kit or re-collection opportunity in such cases.

6.8. To the maximum extent permitted by law, and subject to our Privacy Policy and any applicable informed consent forms, you grant Ani and its affiliates, contractors, subprocessors, laboratories, logistics partners, clinical partners, research partners, and service providers the rights necessary to receive, transport, test, analyze, store, process, use, disclose, retain, destroy, and otherwise handle your samples and related data to provide the Services and for quality assurance, validation, safety, compliance, research, analytics, product development, creation of synthetic data, algorithm refinement, and AI/model improvement purposes consistent with our Privacy Policy.

6.9. Certain Services may be provided under separate provider agreements, research agreements, enterprise agreements, study documents, clinical trial documents, informed consent forms, internal research program terms, or other program-specific materials. To the extent applicable, those documents will govern fees, billing, kit handling, replacement kits, timelines, withdrawal, cancellation, and similar operational terms for the relevant Service.

6.10. These Terms do not themselves create any right to obtain Services or kits from Ani through a retail website or app model. Any paid internal research program or other paid Ani service will be governed by separate written materials applicable to that program.

6.11. Ani may refuse or cancel access to Services, kit fulfillment, registrations, or participation for safety, fraud, legal, compliance, inventory, serviceability, partner, protocol, or operational reasons.

6.12. Ani may change, suspend, or discontinue test lines, score offerings, service offerings, or kit families. If a Service is discontinued, Ani may offer a replacement, substitute, updated workflow, or other accommodation in its discretion where appropriate.

6.13. Processing, manufacturing, shipping, testing, or reporting may be delayed by laboratory capacity, sample issues, partner delays, regulatory changes, customs delays, carrier issues, supply shortages, public health events, technical issues, or other causes outside our reasonable control. Ani is not liable for such delays to the maximum extent permitted by law.

7. Research Participation and Study Activities

7.1. Some Services are part of research, validation, product development, or study-related activities. Ani’s internal research programs, app-based analysis services, and Talk to Ani features are research-grade only and are not intended for diagnostic or therapeutic use unless a specific Service expressly states otherwise in applicable official written documentation. Your general use of the Services may contribute to Ani’s ongoing research and development efforts as described in our Privacy Policy.

7.2. Some studies or partner programs require a separate informed consent form or separate authorization. Those activities are voluntary unless expressly identified as required for the Service you requested.

7.3. Ani may invite you to participate in optional studies, surveys, questionnaires, longitudinal programs, partner-led studies, or additional consent workflows from time to time. You may accept, decline, or ignore those invitations unless participation is expressly required for a specific Service.

7.4. If you withdraw from a specific study or optional program, the withdrawal will apply as described in the relevant informed consent form, study materials, and applicable law. Withdrawal will not necessarily require deletion or reversal of data already lawfully used, de-identified, aggregated, or included in analyses completed before withdrawal.

7.5. Unless otherwise expressly stated in a separate written agreement, you will not receive compensation, royalties, or ownership rights arising from Ani’s research, publications, know-how, algorithms, products, services, or intellectual property developed using data, samples, feedback, de-identified data, synthetic data, aggregate data, or research findings derived from the Services.

8. Communications by Email, SMS, Phone, Push Notification, and In-App Message

8.1. By creating an account, using the Services, registering a kit, enrolling in a study, requesting testing or analysis, participating in ANI Medical workflows, or otherwise providing your contact information to Ani, you agree that Ani and its affiliates, service providers, subprocessors, providers, clinical sites, research sites, logistics partners, and authorized partners may contact you by email, SMS/text message, phone call, push notification, and in-app message regarding:

• your account, login, security, or identity verification;
• kit registration, shipping, delivery, scheduling, account administration, and related operational matters;
• questionnaires, consent forms, reports, scores, test results, dashboard updates, and research participation;
• provider, care-navigation, support, operational, study, or follow-up communications; and
• program, service, feature, survey, educational, promotional, or marketing communications, where permitted by law and subject to your communication preferences and any required opt-ins.

8.2. By providing your mobile phone number and affirmatively opting in where required, you consent to receive recurring automated or non-automated SMS/text messages from Ani regarding Ani and ANI Medical. Message frequency varies. Message and data rates may apply. Consent to receive promotional or marketing text messages is not a condition of participation in the Services.

8.3. Your consent to receive calls or texts applies to Ani and the specific Ani messaging program for which you opted in. It does not authorize unrelated third parties to contact you.

8.4. You may opt out of marketing emails by using the unsubscribe link in the message or contacting us. You may opt out of marketing or non-essential SMS/text messages by replying STOP to the applicable message. You may receive a final confirmation text after opting out. Transactional, operational, safety, security, legal, and certain service-related communications may still be sent where permitted by law.

8.5. For SMS support, you may reply HELP where available or contact us at info@ani.ai.

8.6. You understand that email and SMS/text messages are not always encrypted and may not be secure. If you choose to send or receive health information or other sensitive information by email or SMS/text, you do so at your own risk.

8.7. You represent that the contact information you provide is yours or that you are authorized to receive communications at that address or number and to incur any carrier or usage charges associated with those communications.

8.8. Neither Ani nor carriers are liable for delayed or undelivered messages.

9. Privacy Policy and Data Practices

9.1. Your use of the Services is also governed by our Privacy Policy, which is incorporated into these Terms by reference.

9.2. You acknowledge that Ani may collect, use, process, store, disclose, transfer, retain, pseudonymize, de-identify, anonymize, aggregate, synthesize, and otherwise handle your information as described in these Terms, the Privacy Policy, and any applicable consent forms.

9.3. Ani may use affiliates, subsidiaries, subcontractors, cloud providers, laboratories, shipping providers, analytics providers, customer support tools, CRM systems, payment processors where applicable, LLM providers, research partners, and other service providers or partners to provide the Services.

9.4. Ani may access medical information or connect to third-party health platforms only where you or an authorized partner or provider has validly authorized such access and where such access is permitted by applicable law.

9.5. Your information may be processed in the United States, Croatia, and other jurisdictions where Ani, its affiliates, or its service providers operate, subject to applicable law and the protections described in the Privacy Policy.

9.6. Ani may collect service usage, operational, diagnostic, telemetry, performance, and analytics data relating to use of the Services (“Usage Data”). Subject to applicable law and the Privacy Policy, Ani may use Usage Data for security, fraud prevention, service analytics, benchmarking, product improvement, model monitoring, quality assurance, capacity planning, and general business operations.

10. Talk to Ani, AI Features, Prompts, Outputs, and Improvement Rights

10.1. The Services may include conversational, automated, predictive, and AI-enabled features, including Talk to Ani. These features may generate summaries, recommendations, educational content, workflow suggestions, reports, or other outputs (“Outputs”) based on prompts, questions, messages, voice inputs, uploaded materials, feedback, and other content you submit (“Inputs”).

10.2. You acknowledge that AI features may produce incomplete, inaccurate, outdated, biased, or inappropriate Outputs. Outputs are provided for informational, educational, support, research, or operational purposes only and must not be treated as medical advice or as the sole basis for clinical, health, legal, financial, safety, or other high-stakes decisions.

10.3. As between you and Ani, and subject to the rights you grant in these Terms, you retain whatever rights you may have in your Inputs. You grant Ani and its affiliates, contractors, subprocessors, model providers, and service providers the rights necessary to host, store, copy, process, transmit, display, analyze, and otherwise use Inputs and Outputs to provide, operate, secure, maintain, support, and troubleshoot the Services and to comply with law.

10.4. Except where you separately consent or where another lawful basis applies, Ani will use Inputs, Outputs, interaction logs, and related AI interaction data for model training, fine-tuning, AI improvement, analytics, and product development only in pseudonymized, de-identified, aggregate, or synthetic forms consistent with the Privacy Policy.

10.5. You must not submit confidential third-party information, regulated health information, personal data of others, trade secrets, or other sensitive materials to AI features unless you are authorized to do so and such use is permitted by law and these Terms.

10.6. You are solely responsible for your use of Outputs. You must not represent Outputs as human-generated, clinically validated, professionally verified, or suitable for diagnostic or therapeutic use unless they have in fact been independently reviewed and validated by an appropriately qualified person.

11. User Content, Feedback, and Public Materials

11.1. If you post, upload, submit, transmit, or otherwise make available content through the Services, social features, support channels, testimonials, reviews, surveys, public forums, or other communications (“User Content”), you are solely responsible for that content.

11.2. You represent and warrant that you have all rights necessary to provide User Content and that your User Content does not violate any law, third-party right, contract, confidentiality obligation, or these Terms.

11.3. You grant Ani a worldwide, royalty-free, irrevocable, perpetual, sublicensable, transferable right to host, store, copy, reproduce, modify, adapt, publish, display, distribute, create derivative works from, and otherwise use User Content as needed to provide the Services and for marketing, research, analytics, product development, and other lawful business purposes, subject to our Privacy Policy where applicable.

11.4. If you provide suggestions, ideas, enhancement requests, corrections, recommendations, comments, or other feedback about the Services (“Feedback”), you grant Ani an unrestricted, perpetual, irrevocable, transferable, sublicensable, royalty-free right to use and exploit that Feedback for any purpose without notice, attribution, or compensation to you.

12. Intellectual Property, Software, Trademarks, and Limited License

12.1. The Services, including software, interfaces, designs, workflows, text, graphics, reports, content, scores, models, algorithms, datasets, know-how, and other materials made available by Ani other than your Inputs and User Content, are owned by Ani or its licensors and are protected by intellectual property and other laws.

12.2. Subject to these Terms, Ani grants you a limited, non-exclusive, revocable, non-transferable, non-sublicensable license to access and use the Services for your personal, internal, or otherwise authorized business or research purposes. Software and digital functionality provided as part of the Services are licensed, not sold. No rights are granted except as expressly stated.

12.3. Except as expressly allowed by us in writing, you may not copy, modify, distribute, reverse engineer, create derivative works of, scrape, resell, lease, sublicense, or otherwise exploit the Services or any part of them.

12.4. Subject to applicable law and the Privacy Policy, Ani owns all right, title, and interest in and to the Services and in any service improvements, scoring systems, report formats, workflows, models, algorithms, Usage Data, benchmarks, and de-identified, aggregate, statistical, or synthetic datasets and analyses generated by or for Ani through operation of the Services.

12.5. Ani names, logos, marks, service names, product names, and branding are our trademarks or the trademarks of our licensors. These Terms do not grant you any right to use them except with our prior written permission.

12.6. If you believe content on the Services infringes your intellectual property rights, you may send a notice to the contact information in Section 23 with sufficient detail for us to review the claim.

13. Prohibited Conduct and Breach

13.1. You agree not to:

• use the Services in violation of any law, regulation, professional rule, study protocol, or third-party right;
• provide false, misleading, or unauthorized information, samples, credentials, or consents;
• use the Services for emergency monitoring, crisis response, or time-critical care escalation;
• upload or disclose information you are not authorized to upload or disclose;
• misuse, probe, scan, or interfere with the security, integrity, or availability of the Services;
• scrape, harvest, mine, or systematically extract data or content from the Services;
• use the Services to build or improve a competing product except as expressly permitted in writing;
• submit malware, harmful code, deceptive content, or abusive, threatening, defamatory, obscene, or infringing materials;
• use AI Outputs in a misleading way, including representing AI-generated content as verified medical or human professional judgment when it has not been independently reviewed; or
• share kits, credentials, access tokens, or regulated outputs with unauthorized persons.

13.2. We may monitor use of the Services for trust, safety, compliance, fraud prevention, and operational reasons. If we believe you have violated these Terms, we may remove content, reject samples, suspend services, terminate accounts, block access, cancel participation or service access, and pursue any available legal or equitable remedy.

14. Third-Party Services and Partners

14.1. The Services may involve third-party laboratories, providers, clinics, LLM providers, shipping carriers, cloud infrastructure, app stores, partner research institutions, analytics providers, payment processors where applicable, and other vendors or partners.

14.2. Ani is not responsible for the acts, omissions, products, services, policies, or terms of independent third parties except to the extent required by law or expressly stated in a separate written agreement.

14.3. Third-party services, models, infrastructure, or integrations may be subject to additional terms and may change or become unavailable without notice.

14.4. Your dealings with independent providers, research institutions, pharmacies, laboratories, shipping carriers, payment providers, or other third parties are solely between you and those parties except to the extent Ani expressly undertakes a responsibility in writing.

15. Separate Agreements and Program Documents

15.1. Many Ani Services are provided through separate agreements, research protocols, clinical trial documents, informed consent forms, institutional arrangements, enterprise agreements, or provider agreements. Those documents may contain service-specific terms regarding scope, logistics, fees, reimbursement, kit handling, replacement, withdrawal, or termination.

15.2. If there is a conflict between these Terms and a specific document governing a particular Ani program, study, clinical trial, provider relationship, or enterprise relationship, the more specific document will control for that specific relationship or Service.

15.3. Nothing in these Terms obligates Ani to make the Services available through a retail website model or consumer subscription model. Paid internal research programs or other paid Ani services, if any, are governed by separate written terms applicable to those programs.

16. User Representations, Risks, Warnings, and Regulatory Statements

16.1. By using the Services, you represent, warrant, and acknowledge that:

• you are authorized to provide all information, samples, consents, and instructions that you provide to Ani;
• any sample submitted is from the person identified in connection with that sample and was collected and shipped in accordance with the applicable instructions;
• you will not rely on Ani’s Services for emergency care, diagnosis, treatment, or therapeutic decision-making;
• you are responsible for following service instructions, kit instructions, warnings, timelines, storage requirements, and study or program materials;
• if you share your reports, scores, outputs, samples, kits, or account access with another person, you assume the risks associated with that sharing; and
• you will consult a qualified healthcare professional before making medical or treatment decisions or making health-related changes based on the Services, especially if you are pregnant, nursing, trying to become pregnant, have a medical condition, are recovering from surgery, have allergies, are taking medication, or are under active medical care.

16.2. You understand that the Services may involve risks and limitations, including:

• discomfort, inconvenience, embarrassment, collection errors, shipping delays, or sample failure associated with sample collection and return;
• inaccurate, incomplete, invalid, delayed, or changing reports, scores, recommendations, or Outputs;
• discomfort, irritation, collection-related issues, allergic reactions, sensitivities, or lack of benefit from research-grade services, kits, procedures, food products, supplements, nutritional products, or recommendations;
• anxiety, concern, or stress caused by health-related information, research participation, or reports;
• privacy or security risks that can arise despite commercially reasonable safeguards; and
• unknown or unforeseeable risks associated with evolving scientific, digital, or AI-enabled products.

16.3. If you or a child for whom you are responsible experience any adverse reaction, unexpected symptom, or other urgent issue during or after participation in a Service, use of a kit, or sample collection, stop participation as appropriate and seek immediate professional medical help.

16.4. Regulatory Statements and Claims:

• Unless a specific Ani Service expressly states otherwise in applicable official written documentation, no Ani test, kit, report, score, dashboard, software feature, AI feature, food product, supplement, nutritional product, or other Service is intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease, or as a therapeutic product.
• Ani Services are research-grade only, are not intended to function as diagnostics or therapeutics, and should not be relied upon as such. This applies equally to any food products, supplements, or nutritional products provided through an Ani service or program.
• Any statements appearing on Ani websites, mobile applications, dashboards, kit materials, reports, food product materials, supplement materials, or marketing materials should be interpreted consistently with this limitation unless a specific Service expressly states otherwise in applicable official written documentation.

17. Disclaimer of Warranties

THE SERVICES ARE PROVIDED “AS IS” AND “AS AVAILABLE” WITHOUT WARRANTIES OF ANY KIND, WHETHER EXPRESS, IMPLIED, STATUTORY, OR OTHERWISE.

TO THE MAXIMUM EXTENT PERMITTED BY LAW, ANI DISCLAIMS ALL WARRANTIES, INCLUDING ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE, NON-INFRINGEMENT, ACCURACY, QUALITY, AVAILABILITY, SECURITY, QUIET ENJOYMENT, AND ANY WARRANTIES ARISING OUT OF COURSE OF DEALING OR USAGE OF TRADE.

ANI DOES NOT WARRANT THAT THE SERVICES, REPORTS, SCORES, OUTPUTS, RECOMMENDATIONS, TEST RESULTS, OR COMMUNICATIONS WILL BE COMPLETE, ACCURATE, ERROR-FREE, TIMELY, SECURE, OR SUITABLE FOR ANY PARTICULAR PURPOSE OR THAT THEY WILL ACHIEVE ANY PARTICULAR HEALTH, CLINICAL, COMMERCIAL, OR RESEARCH OUTCOME.

18. Limitation of Liability

TO THE MAXIMUM EXTENT PERMITTED BY LAW, ANI AND ITS AFFILIATES, OFFICERS, DIRECTORS, EMPLOYEES, CONTRACTORS, LICENSORS, SERVICE PROVIDERS, PARTNERS, AND AGENTS WILL NOT BE LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, PUNITIVE, OR CONSEQUENTIAL DAMAGES, OR FOR ANY LOSS OF PROFITS, REVENUE, DATA, GOODWILL, BUSINESS INTERRUPTION, LOSS OF OPPORTUNITY, OR HEALTH-RELATED OUTCOME, ARISING OUT OF OR RELATING TO THE SERVICES OR THESE TERMS, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

TO THE MAXIMUM EXTENT PERMITTED BY LAW, THE TOTAL AGGREGATE LIABILITY OF ANI FOR ALL CLAIMS ARISING OUT OF OR RELATING TO THE SERVICES OR THESE TERMS WILL NOT EXCEED THE GREATER OF (A) THE AMOUNT YOU PAID TO ANI FOR THE APPLICABLE SERVICE DURING THE TWELVE (12) MONTHS BEFORE THE EVENT GIVING RISE TO THE CLAIM, OR (B) ONE HUNDRED U.S. DOLLARS (USD $100), IF YOU HAVE NOT PAID ANI ANY FEES.

NOTHING IN THESE TERMS LIMITS LIABILITY THAT CANNOT BE LIMITED UNDER APPLICABLE LAW.

19. Indemnification

You agree to defend, indemnify, and hold harmless Ani and its affiliates, officers, directors, employees, contractors, licensors, providers, and agents from and against any claims, demands, actions, liabilities, damages, judgments, losses, costs, and expenses, including reasonable attorneys’ fees, arising out of or relating to:

• your use of the Services;
• your Inputs, User Content, samples, or data;
• your violation of these Terms or applicable law;
• your violation of any third-party right; or
• if you are a Provider User, your clinical activities, patient care decisions, failure to obtain required consent, or failure to comply with professional or legal obligations.

20. Governing Law, Arbitration, and Class Action Waiver

20.1. These Terms are governed by the laws of the State of California, without regard to conflict of laws principles, except to the extent preempted by U.S. federal law.

20.2. Before filing a claim, you and Ani agree to try to resolve the dispute informally by sending written notice describing the dispute and the requested relief. You must send your notice to info@ani.ai and to the mailing address in Section 23. We will send our notice to the contact information associated with your account.

20.3. Except for claims that may be brought in small claims court, claims for injunctive or equitable relief relating to misuse of intellectual property or confidential information, or claims that are not subject to arbitration under applicable law, any dispute arising out of or relating to these Terms or the Services will be resolved by binding arbitration administered by the American Arbitration Association (“AAA”) under its Consumer Arbitration Rules or other AAA rules that AAA determines are applicable.

20.4. Arbitration will be conducted on an individual basis only and not as a class, consolidated, coordinated, collective, or representative action. You and Ani each waive any right to a jury trial and any right to participate in a class action.

20.5. Unless otherwise required by law, arbitration may be conducted remotely, by documents, by phone, or by videoconference. If an in-person hearing is required, it will take place in San Francisco County, California, unless AAA rules or applicable law require otherwise.

20.6. You may opt out of this arbitration agreement by sending written notice to info@ani.ai with the subject line “Arbitration Opt-Out” within thirty (30) days after you first agree to these Terms. Your notice must include your full name, the email address associated with your account, and a clear statement that you want to opt out of arbitration.

21. Suspension, Termination, and Changes

21.1. We may suspend, restrict, or terminate your access to some or all of the Services at any time, with or without notice, if we believe that you have violated these Terms, created risk for Ani or others, or if suspension or termination is necessary for legal, regulatory, security, safety, or operational reasons.

21.2. You may stop using the Services at any time. Termination will not affect rights or obligations that by their nature should survive, including rights relating to payments due, data use rights already granted, disclaimers, limitations of liability, indemnities, dispute resolution, and intellectual property protections.

21.3. We may remove, change, or disable features, content, integrations, or functionality for any reason, including safety, platform integrity, provider changes, partner changes, compliance, or operational changes.

21.4. We may close accounts or retire services if they become unlawful, commercially impracticable, insecure, unsupported, or operationally infeasible.

22. Miscellaneous

22.1. These Terms, together with the Privacy Policy and any applicable additional terms, consents, or service-specific agreements, form the entire agreement between you and Ani regarding the Services.

22.2. If any provision of these Terms is held invalid or unenforceable, the remaining provisions will remain in full force and effect.

22.3. Ani may assign or transfer these Terms, in whole or in part, without restriction. You may not assign or transfer these Terms without Ani’s prior written consent.

22.4. No waiver of any provision will be deemed a further or continuing waiver of that or any other provision.

22.5. Notices may be provided through the Services, by email, or by mail.

22.6. Nothing in these Terms creates any joint venture, partnership, employment, fiduciary, or agency relationship between you and Ani.

22.7. You agree to comply with all applicable export, import, sanctions, privacy, and cross-border transfer laws in connection with your use of the Services.

22.8. Ani will not be liable for any failure or delay caused by events beyond its reasonable control, including acts of God, natural disasters, epidemics, pandemics, public health events, labor disputes, carrier failures, customs delays, internet outages, infrastructure outages, governmental actions, or supply shortages.

22.9. Section headings are for convenience only and do not affect interpretation.

23. Contact Information

ANI BIOME PBC

One Embarcadero Center, Suite 1200

San Francisco, CA 94111

Email: info@ani.ai