kalteramso.com, the KALTERA Partner Portal and the Patient Intake

Kaltera Management Group LLC

Version 1. Effective date: October 26, 2026

1. PURPOSE AND HOW THIS DISCLAIMER APPLIES

1.1 This Full Disclaimer (the “Disclaimer”) is issued by Kaltera Management Group LLC, a Delaware limited liability company doing business as KALTERA (“KALTERA”, “we”, “us” or “our”). It forms part of the KALTERA Terms and Conditions, and it applies under the Clinic Preferred Partner Supply Agreement between KALTERA and each verified practice (the “Partner Agreement”) only to the extent, and in the version, that the Partner Agreement provides. It applies to every page of kalteramso.com, the KALTERA Partner Portal, the Patient Intake and the formulary. Capitalized terms not defined here, including “Facility”, “Licensed Practice”, “Qualified Researcher” and “COA”, have the meanings given in the Terms and Conditions.

1.2 Read this Disclaimer in full before entering the practice side of the Site and before placing any order. If you do not understand or accept any part of it, do not proceed.

1.3 A short form of this Disclaimer, set out in Section 14, appears on each product document and marketing material KALTERA issues and in the approved materials used by its account managers and independent sales representatives, and each such document refers to this page.

2. THE TWO PRODUCT CATEGORIES

2.1 KALTERA’s formulary contains two categories of product, and each product is designated in the Portal as belonging to exactly one of them. The categories are supplied under different rules, carry different confirmations at the time of order, and are described using different language. Nothing on the Site, in any document or in any communication should be read as applying the language of one category to a product in the other, and no Research Product is offered, priced or described as an alternative to any Practice Product.

2.2 “Research Products” are research compounds, including research peptides, that are labeled “For Research Use Only” or “Not for Human or Veterinary Use”. Section 3 applies to them.

2.3 “Practice Products” are products that may lawfully be administered to or dispensed for patients by a licensed healthcare practice, including FDA-approved prescription drugs, compounded preparations prepared by a state-licensed compounding pharmacy or an FDA-registered outsourcing facility, injectable nutrients supplied as prescription drugs or compounded preparations, dietary supplements, and related clinical supplies. Section 4 applies to them.

3. RESEARCH PRODUCTS: RESEARCH USE ONLY

3.1 Research Use Only. Research Products are supplied solely for in vitro laboratory research by Qualified Researchers and ship only to the laboratory address the purchaser has designated. They are for research use only. They are not for human use, not for veterinary use, not for diagnostic, therapeutic or clinical use, and not for use in any diagnostic procedure.

3.2 Not evaluated by the FDA. Research Products have not been evaluated, reviewed, cleared or approved by the United States Food and Drug Administration (the “FDA”) or by any other regulatory authority for any use. They are not drugs, foods, dietary supplements, cosmetics or medical devices, and they are not manufactured, labeled or supplied as any of those things. KALTERA makes no representation that any Research Product is approved, safe, effective, pure, stable, sterile or suitable for any use in any human or animal.

3.3 No claims. KALTERA makes no claim, and no statement on the Site or in any material or communication should be read as a claim, that any Research Product can diagnose, treat, cure, mitigate or prevent any disease or condition, improve any aspect of health, appearance, performance, recovery, longevity, weight, metabolism or cognition, or produce any effect in any human or animal. Any description of a Research Product refers to its chemical identity and to its use in laboratory research, and to nothing else. Published literature, if any is referenced, is provided for scientific context only and is not a claim about any product.

3.4 Absolute prohibition on administration. Research Products must never be administered, injected, ingested, applied, inhaled, implanted or otherwise introduced into any human being or animal, by anyone, for any reason. They must never be used in research involving human subjects. They must never be dispensed, prescribed, recommended, compounded, repackaged, relabeled or supplied to any patient or individual. A Licensed Practice that orders a Research Product does so solely as a Qualified Researcher and confirms, with each order, that the product will be used only in in vitro laboratory research at its designated laboratory and will not be administered to any person. KALTERA will refuse, cancel and, where appropriate, report any order where the account, the order or any communication indicates intended use in patients, and may terminate the account.

3.5 Hazards and handling. Research Products are chemicals whose hazards may not be fully characterized. They must be received, stored, handled, used and disposed of only by trained personnel, only in facilities equipped for research chemicals, and only in accordance with the safety data sheet, the COA, the label and all applicable federal, state and local laws. The purchaser assumes all risk arising from receipt, storage, handling, use and disposal.

3.6 Purchaser responsibility. The purchaser is solely responsible for determining whether it may lawfully purchase, possess and use Research Products in its jurisdiction and for its intended research, for the design and conduct of its research, for any permits or approvals its research requires, and for the conduct of everyone who handles the products on its premises.

4. PRACTICE PRODUCTS: LICENSED PRACTICES ONLY

4.1 Licensed practices only. Practice Products are supplied only to Licensed Practices, only for use with the practice’s own patients within the prescriber’s scope of practice and the law of the state of delivery, and never to individuals.

4.2 Prescription drugs and compounded preparations. Prescription drugs and compounded preparations are supplied only on the written order of a prescriber licensed to prescribe them in the state of delivery, and only from a pharmacy, outsourcing facility, manufacturer or distributor licensed to make that supply into that state. The licensed pharmacy, outsourcing facility, manufacturer or distributor accepts the order, sets and invoices its price, warrants the product, and sells or dispenses and ships it to the practice. KALTERA arranges that supply as the practice’s authorized sourcing representative under the Partner Agreement, for a separately stated sourcing fee. KALTERA is not the seller of prescription drugs or compounded preparations, does not set their price, does not take title to them, and does not hold, store, repackage, relabel or distribute them.

4.3 Compounded preparations are not FDA-approved. Compounded preparations are not approved by the FDA. The FDA does not verify the safety, effectiveness or quality of compounded drugs. Compounded preparations are prepared by a licensed pharmacy or outsourcing facility, which is responsible for their quality and for compliance with the standards that apply to it. A pharmacy compounding under section 503A of the Federal Food, Drug, and Cosmetic Act supplies compounded preparations only against a prescription for an identified patient. Compounded preparations for office use, meaning preparations supplied to a practice for administration in the office without a patient-specific prescription, are sourced only from an outsourcing facility registered with the FDA under section 503B, and only where the law of the state of delivery permits the practice to receive and administer them; the practice is responsible for confirming that its state permits office-use supply of the preparation concerned.

4.4 FDA-approved products. FDA-approved products carry FDA-approved labeling, which controls over any description on the Site. Any use of an FDA-approved product that is not described in its approved labeling is a decision made solely by the prescriber in the exercise of independent professional judgment, and KALTERA makes no recommendation, suggestion or claim regarding any such use.

4.5 Dietary supplements. Where the Site or any KALTERA material makes a statement about the effect of a dietary supplement on the structure or function of the body, that statement has not been evaluated by the Food and Drug Administration, the product is not intended to diagnose, treat, cure or prevent any disease, and the statement carries that disclaimer where it appears.

4.6 Injectable nutrients. Injectable nutrients are prescription drugs or compounded preparations, are not dietary supplements, and are supplied only as described in Section 4.2.

4.7 Availability by state. Practice Products are available in the states where they may lawfully be supplied and are not offered where they may not. Statements such as “48 states served” describe the states to which KALTERA currently arranges supply of one or more products; they do not mean that every product is available in every one of those states, and availability may change without notice.

4.8 The prescriber decides. The decision to order any Practice Product, the selection of any product for any patient, the determination of whether a product is appropriate for a patient, dosing, route, frequency, duration, monitoring, and the supervision of administration are the sole responsibility of the Licensed Practice and its prescribers. KALTERA does not recommend any product for any patient or condition, does not provide protocols, and does not review or evaluate any prescriber’s order for clinical appropriateness.

5. WHAT KALTERA IS AND IS NOT

5.1 KALTERA is a sourcing and practice support company. It identifies, qualifies and manages relationships with licensed pharmacies, outsourcing facilities, manufacturers and testing laboratories, arranges supply to verified licensed practices, relays COAs and quality information, and provides non-clinical onboarding, handling, storage and training materials.

5.2 KALTERA is not a pharmacy, a compounding pharmacy, an outsourcing facility, a manufacturer, a wholesale distributor of prescription drugs, a testing laboratory, a healthcare provider, a medical practice or medical group, a telehealth provider or an insurer. KALTERA does not compound, manufacture, test, prescribe, dispense or administer any product, does not practice medicine, pharmacy or any other healing art, and does not provide medical, pharmaceutical or clinical advice.

5.3 No professional relationship is created between KALTERA and any practice, researcher, patient or individual by use of the Site, submission of an application or intake form, or purchase of any product, other than the commercial relationship set out in the Terms and Conditions and the Partner Agreement.

6. NO MEDICAL ADVICE

6.1 Nothing on the Site, in the formulary, in any product document, in any onboarding, handling, storage or training material, or in any communication from KALTERA, its account managers or its independent sales representatives is medical advice, a diagnosis, a treatment recommendation, a protocol, a dosing guideline or a substitute for the independent judgment of a licensed healthcare professional. Handling and storage guidance describes how to receive and store products so that they remain in the condition in which they were shipped; it is not clinical guidance. Training materials are non-clinical and address ordering, documentation, storage and compliance only.

6.2 KALTERA’s independent sales representatives are not clinicians, are not authorized to give clinical guidance, and are permitted to use only KALTERA’s approved materials. Any statement by a representative about the effect, benefit, dosing, use or regulatory status of any product that goes beyond the approved materials is not a statement of KALTERA, is not authorized, and should be reported to info@kalteramso.com so that KALTERA can correct it in writing.

7. CERTIFICATES OF ANALYSIS AND TESTING

7.1 What a certificate of analysis is. A COA is a document issued by the Facility that prepared a lot, or by an independent testing laboratory, reporting the results of the tests named on it, performed on a sample of the named lot, by the methods named on it, on the date stated. KALTERA relays COAs as issued and does not alter them.

7.2 What a COA is not. A COA is not a guarantee that any product is safe, effective, suitable or fit for any purpose. It is not a statement about any unit other than the sample tested, or about the product’s condition after the date of testing, after shipment, or after storage and handling at the practice or laboratory. It does not change a product’s category or regulatory status, and a COA on a Research Product does not make that product suitable for any use in humans or animals.

7.3 Tests performed. Where the Site refers to testing for identity, purity, endotoxin or potency, it means that KALTERA requires the Facility that prepares the product, or an independent laboratory, to perform the tests appropriate to that product and to report them on the COA by the methods stated on it, such as high performance liquid chromatography, mass spectrometry and the limulus amebocyte lysate assay. The COA for each lot states which tests were performed and the results, and no test should be assumed to have been performed unless the COA states it.

7.4 Who performs the testing. Where KALTERA describes testing as “third-party”, “independent” or “verifiable”, it means that the testing was performed by a laboratory that is not the Facility that prepared the lot, and that the COA identifies the laboratory and the lot so that the result can be traced. KALTERA does not itself perform testing unless the Portal expressly states that KALTERA commissioned the testing of a specific lot.

8. FACILITIES AND SOURCING LANGUAGE

8.1 “US-based facilities” means Facilities located in the United States. “ISO-style quality systems” describes the type of quality management system a Facility reports having and is not a representation that the Facility holds any particular ISO certification unless the Site expressly says so for a named Facility. Neither phrase is a representation that the FDA has inspected, registered, licensed or approved any Facility or any product, except where the Site expressly says so for a specific Facility or product.

8.2 Each COA names the Facility that prepared the lot. KALTERA selects and qualifies the Facilities it uses according to its own standards but does not own, operate or control any Facility, and each Facility is responsible for its own licensure, registration, compliance and the quality of the products it prepares.

8.3 “Verified supply”, “verified purity”, “properly sourced”, “reliable supply”, “supply continuity” and similar phrases describe KALTERA’s sourcing process: Facility qualification, license verification of purchasers, a COA on every lot of Research Products and compounded preparations, and management of supply relationships. They are not representations about the safety, efficacy or suitability of any product for any use, and they are not guarantees of availability.

8.4 “Peptide therapeutics”, “hormone support”, “metabolic support”, “injectable nutrients”, “aesthetics and skin” and similar category names on the Site describe categories of Practice Products supplied on a prescriber’s order to Licensed Practices. They do not describe Research Products and must not be read as applying to them.

9. PATIENT INTAKE

9.1 The Patient Intake is a contact form, not a healthcare service. It is a page through which an individual may share basic details and an area of interest so that KALTERA’s team can follow up with general information about independent licensed healthcare providers who may offer that care, and how to contact them. KALTERA is not a healthcare provider. Submitting the intake form does not create a physician and patient relationship, does not entitle anyone to any product, prescription or service, and is not a request for or offer of any product. KALTERA receives no fee, commission or other consideration from any provider for providing information to an individual or for connecting an individual with a provider, pays none, and does not select or rank providers by reference to any commercial relationship with KALTERA.

9.2 Any care an individual later receives is provided by an independent licensed practitioner under that practitioner’s own judgment, agreements, consents and policies. KALTERA does not control, supervise or direct any practitioner’s clinical decisions and is not responsible for the care provided. Availability of care varies by state and by provider and is never guaranteed. Individual results vary, and no outcome is promised.

9.3 The Patient Intake is not for emergencies. If you have a medical emergency, call 911 or go to the nearest emergency department.

10. SITE CONTENT

10.1 Content on the Site is general information, provided for the convenience of licensed practices, and may contain typographical errors, omissions or information that is out of date. We may correct or change content at any time without notice. The label, package insert, safety data sheet and COA accompanying a product control over any description on the Site.

10.2 Statements about KALTERA’s experience, network, standards, pricing, growth, or the markets in which it operates are statements of KALTERA’s own view at the time they are made and are not guarantees of future performance or availability.

10.3 The Site does not currently display testimonials, endorsements or case studies. If any are added, they will reflect the honest experience of the person giving them, will disclose any material connection between that person and KALTERA, and will be accompanied by a statement of the results that practices can generally expect. No testimonial will make or imply any claim about the effect of a Research Product in any human or animal.

10.4 Links to third-party websites are provided for convenience. KALTERA does not control and is not responsible for the content, accuracy or practices of any third-party website, and a link is not an endorsement.

11. REPORTING ADVERSE EVENTS AND COMPLAINTS

11.1 Any adverse event, injury, product complaint, suspected contamination, labeling error or similar issue involving any product must be reported to KALTERA within twenty-four (24) hours at info@kalteramso.com with the product, lot number and a description of the issue. KALTERA relays reports to the Facility concerned. Reporting to KALTERA does not satisfy any obligation a practice or researcher has to report to the FDA, to a state board or to any other authority. Healthcare professionals may report adverse events involving FDA-regulated products to the FDA MedWatch program.

12. ENTRY CONFIRMATION

12.1 Before entering the practice side of the Site you make the confirmations set out in Section 3.1 of the Terms and Conditions. By continuing, you confirm that those statements are true, and KALTERA relies on them.

13. DISCLAIMER OF WARRANTIES AND LIMITATION OF LIABILITY

13.1 THE SITE AND ALL CONTENT ARE PROVIDED “AS IS” AND “AS AVAILABLE”, WITHOUT WARRANTY OF ANY KIND. KALTERA MAKES NO WARRANTY, REPRESENTATION OR CLAIM, EXPRESS OR IMPLIED, ABOUT THE SAFETY, EFFICACY, SUITABILITY, PERFORMANCE, STABILITY, STERILITY OR REGULATORY STATUS OF ANY PRODUCT FOR ANY USE. ANY WARRANTY RELATING TO A PRODUCT KALTERA SELLS IS SET OUT SOLELY IN THE PARTNER AGREEMENT, AND ANY WARRANTY RELATING TO A PRESCRIPTION DRUG OR COMPOUNDED PREPARATION IS GIVEN SOLELY BY THE SUPPLYING FACILITY UNDER ITS TERMS. THE EXCLUSIONS AND LIMITATIONS OF LIABILITY IN THE TERMS AND CONDITIONS AND THE PARTNER AGREEMENT APPLY TO EVERYTHING DESCRIBED IN THIS DISCLAIMER. NOTHING IN THIS DISCLAIMER LIMITS ANY LIABILITY THAT CANNOT BE LIMITED BY LAW.

14. SHORT FORM FOR PRODUCT DOCUMENTS AND MARKETING MATERIALS

14.1 Research Products. Every product document, listing, sell sheet, email and other material concerning a Research Product carries the following statement, and refers to this page: “For Research Use Only. Not for human or veterinary use. Not for diagnostic, therapeutic or clinical use. This product has not been evaluated or approved by the FDA for any use and is sold solely for in vitro laboratory research by qualified researchers. It must never be administered to any person or animal. Full disclaimer at kalteramso.com/disclaimer.”

14.2 Practice Products. Every product document, listing, sell sheet, email and other material concerning a Practice Product carries the following statement, and refers to this page: “Supplied to licensed practices only, on a licensed prescriber’s order where required, by a licensed pharmacy, outsourcing facility, manufacturer or distributor. Compounded preparations are not FDA-approved, and the FDA does not verify their safety, effectiveness or quality. KALTERA is a sourcing company; it is not a pharmacy, a distributor of prescription drugs or a healthcare provider, and it does not provide medical advice. Full disclaimer at kalteramso.com/disclaimer.”

14.3 Use of the short forms is mandatory under KALTERA’s approved-materials rules for account managers and independent sales representatives, and no material is approved without the applicable statement.

15. CHANGES AND CONTACT

15.1 We may update this Disclaimer at any time by posting the updated version on the Site with a new effective date. Changes do not apply to orders placed before the new effective date. Questions may be sent to info@kalteramso.com.