Biormika Medical Advice, Research Use, and Regulatory Disclaimer

Last updated: July 27, 2026 This Medical Advice, Research Use, and Regulatory Disclaimer ( “Medical Disclaimer” or “Disclaimer”) applies to Customer’s and its Users’ access to and use of the Platform and Offerings under the Biormika Master Service Agreement between Biormika and Customer (the “MSA”). Capitalized terms used but not defined in this Disclaimer have the meanings given to them in the MSA. This Disclaimer supplements and is incorporated into the MSA and is effective as of the Effective Date of the MSA or the date Customer first accesses or uses the Platform or Offerings, whichever occurs first, and this Disclaimer shall control with respect to the subject-matters described herein. For purposes of this Disclaimer, “Subject” means an individual from whom, or about whom, Customer Data or other information is collected, derived, generated, uploaded, submitted, analyzed, or otherwise made available to or through the Platform. By accessing or using the Platform or Offerings, Customer acknowledges and agrees to this Disclaimer.

1. Research Use Only; No Clinical Use.

The Platform and Offerings may enable Customer to upload, process, analyze, review, or generate outputs from biologic, research, or other Customer Data, but are provided for research-use purposes only and are not intended to be used, and may not be used, for clinical diagnosis, treatment, patient management, medical decision-making, disease prediction, disease monitoring, disease prevention, therapeutic selection, medication selection, triage, emergency care, or the provision of medical or health care advice. Without limiting the foregoing, the Platform and Offerings are for research use only and not for use in diagnostic procedures, unless expressly stated otherwise in a written agreement signed by Biormika and only to the extent permitted by applicable law.

2. No Medical Advice; No Provider-Patient Relationship.

Biormika is not a health care provider, physician, health plan, health care clearinghouse, clinical laboratory, diagnostic provider, or other provider of medical or health care services. Biormika does not diagnose, treat, monitor, manage, prevent, cure, or mitigate any disease, condition, injury, or health status, and Biormika does not provide medical, clinical, diagnostic, therapeutic, or health care advice. The Platform, Offerings, Documentation, outputs, reports, analyses, and any other information generated by or made available through the Platform are not medical advice and are not a substitute for the professional judgment, advice, diagnosis, treatment, or care of a qualified health care professional. Use of the Platform or Offerings does not create a physician-patient, provider-patient, clinician-patient, fiduciary, treatment, or other health care relationship between Biormika and Customer, any User, any Subject, or any other individual. Any such relationship exists solely between the applicable health care professional and the relevant individual, if at all.

3. No Regulatory Approval or Clinical Validation.

Unless expressly stated in an applicable Order Form or other written agreement signed by Biormika, the Platform and Offerings have not been reviewed, cleared, approved, authorized, certified, registered, validated, or otherwise permitted by the U.S. Food and Drug Administration or any other governmental or regulatory authority for clinical, diagnostic, therapeutic, medical, or patient-management use. Customer will not represent, and will ensure that its Users do not represent, that the Platform, Offerings, outputs, reports, analyses, Documentation, or related information have any such regulatory status. No statement in this Disclaimer, the MSA, any Order Form, the Documentation, any Platform output, or any other Biormika materials will be construed as a representation that the Platform or Offerings are regulated, unregulated, exempt, cleared, approved, authorized, certified, registered, validated, or otherwise permitted for any particular use under applicable law.

4. No Accuracy, Clinical Relevance, or Clinical Utility Warranty.

Customer acknowledges that the Platform outputs may be incomplete, inaccurate, preliminary, non-clinical, not validated for clinical use, not clinically relevant, not applicable to any individual Subject, and not appropriate for use in making any patient-specific diagnosis, treatment, patient-management, or medical decision. Biormika does not warrant that any Platform output will be accurate, complete, clinically valid, clinically useful, clinically actionable, or appropriate for any particular purpose. Customer is solely responsible for determining whether the Platform, Offerings, Customer Data, and any Platform outputs are appropriate for Customer’s intended use.

5. Customer Responsibilities and Professional Judgment.

Customer and its Users are solely responsible for independently reviewing, validating, and determining the appropriateness of any Platform outputs before using, sharing, disseminating, or relying on them for any purpose. Customer will not use, and will ensure that its Users do not use, any Platform output as the sole or primary basis for any clinical, diagnostic, treatment, therapeutic, triage, patient-management, or medical decision. Customer is solely responsible for conducting any validation, verification, review, approval, or other assessment required by applicable law, institutional policy, research protocol, professional standard, or Customer’s internal requirements, and for ensuring that its Users comply with this Disclaimer, the MSA, all applicable Order Forms, and applicable law.

6. No Emergency Use.

The Platform and Offerings are not intended for emergency use or for use in any time-sensitive, acute, life-threatening, or urgent medical situation. Customer will not use, and will ensure that its Users do not use, the Platform or any Platform output in connection with emergency care or urgent clinical decision-making.

7. Communications with Subjects and Third Parties.

Customer is solely responsible for all communications with Subjects, patients, health care providers, researchers, institutions, regulators, governmental authorities, and other third parties regarding Customer Data, Platform outputs, reports, analyses, or other information generated by or through the Platform. Customer will not provide, describe, characterize, or communicate any Platform output as medical advice, diagnostic results, clinical recommendations, treatment recommendations, patient-management recommendations, or patient-specific medical conclusions, or otherwise in a manner that is false, misleading, deceptive, or inconsistent with this Disclaimer, the MSA, the Documentation, or applicable law.

8. Regulatory Claim Restrictions.

Customer will not, and will ensure that its Users do not, market, advertise, label, describe, distribute, disseminate, or otherwise characterize the Platform, Offerings, outputs, reports, analyses, Documentation, or related information as approved, cleared, authorized, certified, registered, validated, clinically actionable, diagnostic, therapeutic, or appropriate for patient-specific medical use, unless expressly authorized in writing by Biormika and permitted by applicable law. Customer will not, and will ensure that its Users do not, make any statement or claim that would reasonably be expected to alter the intended use of the Platform or Offerings from research-use purposes to clinical, diagnostic, therapeutic, medical, or patient-management purposes.

9. Professional Licensure Laws.

Customer is solely responsible for determining and complying with all professional licensure, scope-of-practice, corporate practice of medicine, telemedicine, telehealth, standard-of-care, informed consent, supervision, delegation, documentation, patient-relationship, medical records, research, and health care laws and requirements applicable to Customer, its Users, and any use or dissemination of Customer Data or Platform outputs. Without limiting the foregoing, if Customer or any User uses any Platform output in connection with any patient, Subject, provider, researcher, or health care activity, Customer is solely responsible for complying with all applicable state laws and regulations governing medical practice, telemedicine, telehealth, professional licensure, standard of care, informed consent, supervision, delegation, documentation, and patient relationships.

10. Customer Indemnification.

Customer will defend, indemnify, and hold harmless Biormika and its officers, directors, employees, agents, representatives, contractors, and Affiliates from and against any third-party claim, demand, action, investigation, inquiry, proceeding, loss, liability, damage, fine, penalty, cost, or expense, including reasonable attorneys’ fees, arising out of or relating to: (i) Customer’s or any User’s use, interpretation, dissemination, communication, or reliance on Customer Data, Platform outputs, reports, analyses, or other information generated by or through the Platform; (ii) any diagnosis, treatment, patient-management, clinical, therapeutic, medical, emergency, or health care decision or recommendation made by Customer or any User; (iii) any medical advice or health care advice provided by Customer or any User; (iv) Customer’s or any User’s representation that the Platform, Offerings, outputs, reports, analyses, Documentation, or related information are approved, cleared, authorized, certified, registered, validated, or appropriate for clinical, diagnostic, therapeutic, medical, or patient-management use; (v) Customer’s or any User’s violation of any professional licensure, scope-of-practice, corporate practice of medicine, telemedicine, telehealth, standard-of-care, informed consent, supervision, delegation, documentation, patient-relationship, medical records, research, or health care law; or (vi) any allegation by a Subject, patient, health care provider, researcher, regulator, governmental authority, or other third party arising from Customer’s use or dissemination of Customer Data or Platform outputs.

11. No Limitation of Other Rights.

This Disclaimer does not limit any rights, remedies, disclaimers, limitations, restrictions, or protections available to Biormika under the MSA, any Order Form, any other applicable agreement, or applicable law. Customer’s obligations under this Disclaimer are in addition to, and not in lieu of, Customer’s obligations under the MSA, any Order Form, the Biormika HIPAA and Health Information Disclaimer, and applicable law.