Clinical Disclosures

These Clinical Disclosures (“Disclosures”) are provided in the interest of transparency and regulatory compliance, including with respect to Colombian health law where applicable (Ley 23 de 1981, Resolución 1403 de 2007, Decreto 677 de 1995, and Ley 1751 de 2015). These Disclosures supplement and are incorporated by reference into the Terms of Service and Privacy Policy of BE SATAS LLC, a Delaware limited liability company (“Company”).

BY USING THE PLATFORM OR RECEIVING ANY PRODUCT OR SERVICE COORDINATED THROUGH THE PLATFORM, YOU ACKNOWLEDGE THAT YOU HAVE READ, UNDERSTOOD, AND ACCEPTED THESE DISCLOSURES IN THEIR ENTIRETY.

2.1 The therapeutic substances accessible through the Platform are coordinated pursuant to Signals — structured clinical recommendations issued by independently licensed Practitioners through the Platform’s proprietary signal architecture. A Signal reflects the Practitioner’s independent clinical judgment regarding substance selection, dosage, route of administration, reconstitution protocol, and scheduling. Signals are not prescriptions. They are the Practitioner’s expression of clinical intent, informing the Patient’s autonomous and voluntary decision to pursue a particular therapeutic course.

2.2 Substances accessible through the Platform include therapeutic compounds and bioactive formulations. These substances may be prepared on an individualized basis pursuant to a licensed Practitioner’s clinical recommendation, in accordance with applicable magistral preparation regulations.

2.3 CERTAIN SUBSTANCES ACCESSIBLE THROUGH THE PLATFORM MAY NOT HAVE RECEIVED MARKETING AUTHORIZATION FROM INVIMA (INSTITUTO NACIONAL DE VIGILANCIA DE MEDICAMENTOS Y ALIMENTOS) OR EQUIVALENT REGULATORY BODIES. THESE SUBSTANCES ARE PROVIDED EXCLUSIVELY UNDER THE CLINICAL AUTHORITY OF LICENSED PRACTITIONERS EXERCISING THEIR INDEPENDENT PROFESSIONAL JUDGMENT, AND ARE NOT COMMERCIALLY MARKETED PHARMACEUTICAL PRODUCTS.

2.4 The regulatory framework for magistral preparations differs materially from that of commercially manufactured pharmaceuticals. Magistral preparations are: (a) prepared on an individual-patient basis; (b) prepared pursuant to a specific Practitioner’s clinical recommendation; (c) not subject to the same clinical trial and marketing authorization requirements as commercial drug products; (d) subject to quality control standards appropriate to the preparation methodology employed.

THE COMPANY, THE PLATFORM, AND ALL PRACTITIONERS ACCESSIBLE THROUGH THE PLATFORM MAKE NO WARRANTIES, REPRESENTATIONS, OR GUARANTEES REGARDING:

(a) The efficacy, safety, tolerability, or suitability of any therapeutic substance for any particular condition, indication, or patient;

(b) The achievement of any particular clinical outcome, therapeutic benefit, or health improvement;

(c) The absence of adverse effects, side effects, drug interactions, allergic reactions, or unforeseen complications;

(d) The consistency, potency, purity, or sterility of any preparation beyond the specifications certified by the preparing facility;

(e) The accuracy, completeness, or currency of any clinical information, educational content, or substance literature provided through the Platform.

ALL THERAPEUTIC INTERVENTIONS ARE UNDERTAKEN AT THE PATIENT’S OWN RISK. The Patient’s decision to pursue any treatment based on a Signal is voluntary and informed by the Patient’s own independent evaluation, in consultation with their licensed Practitioner.

4.1 Prior to the initiation of any treatment protocol, the recommending Practitioner is solely responsible for obtaining the Patient’s informed consent. Informed consent includes, at minimum: (a) explanation of the proposed treatment Signal and its expected benefits; (b) disclosure of material risks and potential side effects; (c) discussion of alternative treatments, including non-treatment; (d) opportunity for the Patient to ask questions and receive answers; (e) the Patient’s voluntary agreement to proceed.

4.2 The Platform may collect electronic consent records as a convenience to Practitioners. THE ELECTRONIC COLLECTION OF CONSENT BY THE PLATFORM DOES NOT CONSTITUTE THE OBTAINING OF INFORMED CONSENT. The obligation to obtain meaningful, clinically adequate informed consent rests exclusively with the recommending Practitioner. THE COMPANY ASSUMES NO LIABILITY FOR ANY DEFICIENCY IN THE INFORMED CONSENT PROCESS.

By using the Platform and receiving any product or treatment, You expressly acknowledge, represent, and warrant that:

(a) You have voluntarily sought access to therapeutic substances through the Platform of Your own free will, without coercion, undue influence, or misrepresentation by the Company;

(b) You understand that the substances are individualized preparations, not commercially approved drug products, and that the regulatory and evidentiary framework governing such substances differs from that of commercially marketed pharmaceuticals;

(c) You have disclosed to Your Practitioner all relevant medical history, current medications, allergies, pre-existing conditions, and other health information necessary for safe clinical recommendations;

(d) You will follow all recommended administration protocols, storage requirements, and safety instructions exactly as directed by Your Practitioner’s Signal;

(e) You will immediately report any adverse reaction, unexpected symptom, or health concern to Your Practitioner and, where appropriate, to emergency medical services;

(f) You will not share, transfer, sell, or provide any substance obtained through the Platform to any third party;

(g) You assume full responsibility for the proper storage, handling, reconstitution, and administration of all substances received, in accordance with the accompanying instructions and Your Practitioner’s Signal;

(h) You understand that discontinuing or modifying any treatment without consulting Your Practitioner may result in adverse health consequences for which the Company bears no responsibility.

6.1 All substances coordinated through the Platform are subject to quality control protocols including, where applicable: identity testing, potency verification, sterility testing, endotoxin testing, and stability assessment. Testing is performed by qualified laboratories, and results are maintained in the Platform’s quality management records.

6.2 Notwithstanding the foregoing, THE COMPANY DOES NOT INDEPENDENTLY MANUFACTURE, TEST, OR CERTIFY ANY SUBSTANCE. Quality assurance is performed by the preparing facility and its designated laboratories. The Company facilitates the coordination of this process but does not assume liability for testing accuracy, methodology, or completeness.

6.3 Each dispensed unit carries a unique seal identifier linking the preparation to its batch, lot, testing records, and recommending Practitioner. This traceability system is maintained for regulatory compliance and adverse event investigation purposes.

7.1 In the event of any adverse reaction, side effect, or unexpected clinical event, the Patient shall: (a) seek immediate medical attention if the event presents a risk to life, health, or safety; (b) promptly notify the recommending Practitioner; (c) report the event to the Company via adverse-events@besatas.com.

7.2 The Company will maintain adverse event records and, where required by law, report to the applicable regulatory authority. THE COMPANY’S OBLIGATION TO REPORT DOES NOT CONSTITUTE AN ADMISSION OF FAULT, CAUSATION, OR LIABILITY.

Many substances require specific storage conditions (e.g., refrigeration between 2–8°C, protection from light, protection from moisture). Failure to comply with storage and handling instructions may compromise product integrity, efficacy, and safety. THE COMPANY AND THE PREPARING FACILITY DISCLAIM ALL LIABILITY FOR ANY ADVERSE OUTCOME RESULTING FROM IMPROPER STORAGE, HANDLING, RECONSTITUTION, OR ADMINISTRATION BY THE PATIENT OR ANY THIRD PARTY.

THE COMPANY IS A TECHNOLOGY PLATFORM PROVIDER. IT IS NOT A HEALTHCARE PROVIDER, CLINICAL RECOMMENDER, PREPARER, OR CLINICAL DECISION-MAKER. The Company’s role is limited to: (a) facilitating the connection between Patients and licensed Practitioners; (b) providing technology tools for Signal management and treatment coordination; (c) coordinating order fulfillment logistics; (d) maintaining quality traceability records.

TO THE MAXIMUM EXTENT PERMITTED BY LAW, THE COMPANY SHALL NOT BE LIABLE FOR ANY CLINICAL OUTCOME, HEALTH CONSEQUENCE, INJURY, ILLNESS, ADVERSE REACTION, OR DEATH ARISING FROM OR RELATED TO: (a) any clinical decision or Signal issued by any Practitioner; (b) any substance administered to or consumed by any Patient; (c) any deficiency in the informed consent process; (d) any failure of a Patient to follow recommended protocols; (e) any interaction between substances obtained through the Platform and other medications, supplements, or treatments.

The Platform coordinates with operational partners within the regulatory framework of the Republic of Colombia, including but not limited to:

Ley 23 de 1981: Establishes the ethical framework for medical practice, including requirements for informed consent and the practitioner-patient relationship.

Resolución 1403 de 2007: Governs the preparation, quality control, and release of magistral preparations, providing the legal basis under which individualized therapeutic substances may be prepared pursuant to a licensed Practitioner’s clinical recommendation.

Decreto 677 de 1995: Establishes the regulatory framework for pharmaceutical products, distinguishing between commercially manufactured products requiring INVIMA registration and magistral preparations prepared on an individual-patient basis.

Ley 1751 de 2015: Recognizes health as a fundamental right and establishes the principle of patient autonomy in making informed healthcare decisions.

The Company does not provide legal, regulatory, or compliance advice, and Users should consult their own legal counsel regarding the regulatory status of any substance or service in their jurisdiction.

Substances prepared within the Republic of Colombia are subject to Colombian law. If a Patient resides in or receives shipment in a jurisdiction outside of Colombia, the Patient is solely responsible for compliance with the importation laws, customs regulations, controlled substance schedules, and pharmaceutical regulations of the destination jurisdiction. THE COMPANY MAKES NO REPRESENTATION REGARDING THE LEGALITY OF ANY SUBSTANCE IN ANY JURISDICTION AND ASSUMES NO LIABILITY FOR REGULATORY CONSEQUENCES OF CROSS-BORDER RECEIPT.

TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, YOU HEREBY VOLUNTARILY, KNOWINGLY, AND IRREVOCABLY WAIVE AND RELEASE THE COMPANY, ITS DIRECTORS, OFFICERS, EMPLOYEES, AGENTS, AFFILIATES, AND SERVICE PROVIDERS FROM ANY AND ALL CLAIMS, DEMANDS, CAUSES OF ACTION, DAMAGES, LOSSES, AND LIABILITIES OF ANY NATURE, WHETHER KNOWN OR UNKNOWN, SUSPECTED OR UNSUSPECTED, ARISING OUT OF OR IN ANY WAY CONNECTED WITH YOUR USE OF THE PLATFORM, ANY TREATMENT RECEIVED, ANY SIGNAL ISSUED, OR ANY SUBSTANCE ADMINISTERED.

This waiver and release is intended to be as broad and inclusive as permitted by applicable law, and if any portion is held invalid, the remainder shall continue in full force and effect.

Clinical Inquiries: clinical@besatas.com
Adverse Event Reporting: adverse-events@besatas.com
Quality Assurance: quality@besatas.com
Legal Department: legal@besatas.com