Terms of use

Version 0.1 · Draft · Effective date to be set

Summary

Plain-language summary. It is not a substitute for the full terms below, but where the two conflict in spirit, we intend the summary to be an accurate description of what we do.

• We do not practice medicine. Nothing here is medical advice, and using this site does not create a practitioner–participant relationship.
• We do not sell, supply, or broker any substance, and we carry no advertising, affiliate links, or referrals to anyone who does.
• Cohort 01 is a self-directed personal research cohort inside a research club. It is not medical care, diagnosis or treatment.
• You pay one stage at a time. Nothing is owed for a stage you were not admitted to.
• If our instrument cannot distinguish caffeine from placebo on you, you are refunded and you do not pay for the next phase.
• Much of what we publish is uncertain, and we say so. We label evidence by strength and mark unknowns as unknown rather than writing around them.

1. Who we are and what this is

These Terms govern your use of somaforming.com and the services offered through it (the "Services").

The Services are operated by Cosmist Bio, Inc., a corporation organized under the laws of [STATE] ("Cosmist", "we", "us").

The registry, the protocol standard, and the Patient Safety Organization referenced in our wider work are intended to be operated by Cosmist Bio, a separate 501(c)(3) nonprofit organization. That entity is not yet established. Until it is, those components are operated by Cosmist Bio, Inc. under the same commitments.

By using the Services you agree to these Terms. If you do not agree, do not use the Services.

2. No medical advice; no professional relationship

The Services provide information, software tools, and research infrastructure. They do not provide medical, pharmaceutical, legal, or financial advice.

No content available through the Services is a diagnosis, a treatment recommendation, or a prescription for any individual. Use of the Services does not create a physician–participant, pharmacist–participant, or any other professional–client relationship between you and Cosmist or any of its personnel.

You should consult a qualified, licensed healthcare professional regarding any health condition, and before starting, stopping, or changing anything you take. Do not disregard or delay seeking professional medical advice because of something you read here.

If you believe you are experiencing a medical emergency, contact your local emergency services.

3. Regulatory status

No substance discussed anywhere in the Services is endorsed, recommended, or represented as safe or effective by us. Some substances referenced are not approved by the U.S. Food and Drug Administration for any indication, and some may not be lawfully available in your jurisdiction. Regulatory status varies by country, by state, and over time.

For approved drugs used outside a new indication, the exemption analysis under 21 CFR 312.2(b) applies. That determination is the IRB's, not ours.

Nothing in these Terms should be read as a representation that FDA has reviewed or cleared any component of the Services.

4. Eligibility

You must be at least 18 years old to use the Services. Admission to cohort 01 is subject to its own screening criteria, which are published in full at /protocol/ and which include an age range, medication exclusions, and criteria that exist to protect the shared variance estimate rather than to protect you. We identify which is which.

We may decline any application, at our discretion, without giving a reason.

5. What we do not do

We do not, and will not:

• sell, distribute, compound, import, or supply any drug, peptide, biologic, or other substance;
• carry advertising, sponsored placement, affiliate links, referral fees, or revenue share from any seller of any substance;
• direct you to a specific vendor, pharmacy, or supplier, or facilitate a transaction for any substance;
• accept payment from any manufacturer or seller of any substance in exchange for its inclusion, ranking, or characterization anywhere in the Services.

These are structural commitments, not preferences. If we ever change any of them, we will say so prominently and in advance.

6. Cohort participation and money

6.1 What you are joining

Cohort 01 is a self-directed personal research cohort inside a research club. Participants make their own decisions about their own personal research and share results at their discretion. Cosmist assists and does not own the results. Protocols are clinician-supervised, with IRB oversight and informed consent.

6.2 Stage-by-stage payment

Participation is priced by stage: the two-day demo is free if you qualify; the 14-day calibration stage is $1,500; the intervention stage is $3,500. $5,000 in total. You are charged for a stage only on admission to that stage, and admission to each stage is limited and based on the criteria published at /protocol/.

Being admitted to one stage does not entitle you to the next, and not being admitted to the next stage is not a breach of these Terms.

6.3 The instrument-sensitivity refund

If the composite measure does not distinguish caffeine from placebo within you at the threshold published in the protocol, you are refunded for the calibration stage and you do not pay for the intervention stage. We will tell you that our instrument is not sensitive on you, which is a statement about our method and not about you.

6.4 What a result is and is not

An individual verdict at p < 0.05 is only reachable for effects of approximately 1.5 personal standard deviations or larger. Your report therefore expresses a posterior probability rather than a binary answer, and "these levers are indistinguishable for you" is a valid and final result of the protocol, not a failure of it and not a refund event. This is stated before you pay, at /protocol/.

6.5 Withdrawal

You may withdraw at any time. Data already de-identified and aggregated cannot be retrieved or deleted, because by design it can no longer be linked to you. We say this before you contribute rather than after.

7. Evidence, uncertainty, and accuracy

Content in the Services is drawn from published literature, regulatory records, computational predictions, and — where noted — observations from the cohort. These are different kinds of information and we label them differently. Computational predictions never establish clinical safety, efficacy, dose, or absence of interaction.

We label unknowns as unknown. Absence of a finding means we did not find one, which is not the same as there being none.

Content may be incomplete, out of date, or wrong. We correct errors when we find them and we date our claims. You remain responsible for verifying anything you rely on.

8. User content and conduct

You retain ownership of content you submit. You grant us a non-exclusive, worldwide, royalty-free license to host, process, and — in de-identified and aggregated form — publish and analyze it for the purposes described in these Terms.

You will not use the Services to: violate any law; infringe anyone's rights; submit another person's identifiable health information without lawful authority; misrepresent your professional credentials; market, promote, or facilitate the sale of any substance; or attempt to re-identify any individual in any dataset.

9. Third-party sources and links

The Services reference external databases, publications, and models. We do not control them, do not warrant them, and are not responsible for their content. A link is not an endorsement.

10. Intellectual property

Except for content you submit and any materials we publish under an open license, the Services and their contents are owned by us or our licensors. We grant you a limited, revocable, non-transferable license to use the Services as permitted by these Terms.

11. Disclaimer of warranties

THE SERVICES ARE PROVIDED "AS IS" AND "AS AVAILABLE," WITHOUT WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, ACCURACY, AND NON-INFRINGEMENT. WE DO NOT WARRANT THAT THE SERVICES WILL BE UNINTERRUPTED, ERROR-FREE, OR THAT ANY CONTENT IS COMPLETE OR CURRENT.

12. Limitation of liability

TO THE MAXIMUM EXTENT PERMITTED BY LAW, WE WILL NOT BE LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, EXEMPLARY, OR PUNITIVE DAMAGES, OR FOR ANY LOSS OF PROFITS, DATA, GOODWILL, OR FOR PERSONAL INJURY OR DEATH ARISING FROM YOUR USE OF THE SERVICES OR FROM ANY DECISION MADE OR ACTION TAKEN IN RELIANCE ON THEM.

OUR TOTAL AGGREGATE LIABILITY WILL NOT EXCEED THE GREATER OF THE AMOUNT YOU PAID US IN THE TWELVE MONTHS PRECEDING THE CLAIM, OR ONE HUNDRED U.S. DOLLARS.

Some jurisdictions do not permit certain exclusions; in those jurisdictions our liability is limited to the maximum extent permitted.

13. Indemnification

You will indemnify and hold harmless Cosmist, its affiliates, and their personnel from claims arising out of your use of the Services, your content, your breach of these Terms, or your violation of any law or third-party right — including, if you are a healthcare professional, any claim arising from your clinical decisions.

14. Jurisdiction

The Services are operated from the United States and directed to users in the United States. We make no representation that they are appropriate or available elsewhere.

15. Changes

We may modify these Terms. Material changes will be posted with a revised effective date and, where we hold your contact details, notified in advance. Changes to Section 5 or Section 6.3 will be published at least thirty days before taking effect, because those provisions are the basis on which people decide to trust us.

16. Governing law

These Terms are governed by the laws of [STATE], without regard to conflict of laws principles. [DISPUTE RESOLUTION MECHANISM — a decision for counsel.]

17. Contact

Cohort 01 — apply@somaforming.com
General — cosmist.bio

Open items for counsel

• State of incorporation for Cosmist Bio, Inc., and which entity contracts with a cohort participant.
• The participation agreement signed before the free demo, and how it interacts with these Terms.
• IRB determination for the personal fourth arm, and for approved drugs used outside a new indication under 21 CFR 312.2(b).
• Whether stage-by-stage pricing and the instrument-sensitivity refund require any specific consumer disclosure.
• Refund mechanics and timing, and whether calibration-stage fees should be held separately until the gate is evaluated.
• State-by-state review of professional licensure and corporate practice of medicine, given that a protocol physician approves the personal arm.
• Accessibility statement.
• Consumer health data statutes (Washington My Health My Data and equivalents), which apply beyond HIPAA. The application form deliberately collects no health data; the physician-facing intake after the screening call does, and is where this bites.

Version 0.1 (terms) · Adapted from cosmist.bio/terms v0.1 · Regulatory status in this area is changing; we date every factual claim and correct these pages when it moves.