Intended-Use & Supply Policy

This is Auvum Bio's written supply policy — the rule that decides who receives material from us and who does not. It applies to everything we supply: MSC-derived extracellular vesicles ("exosomes"), hTSC lines, and peptides.

What this material is for

Everything we supply is for laboratory research, or for clinical investigation carried out under whatever regulatory authorisation applies where that work runs — an active IND, IRB/IEC approval, or the equivalent national regulatory authorisation outside the United States. That authorisation has to already be in place, and it has to cover the specific work the material is going toward. We don't supply on the promise that approval is "in progress" or "not really needed for this."

What none of it is

No material Auvum supplies is approved for human therapeutic use in any market — not the exosome preparations, not the hTSC lines, not the peptides. Nothing here is a cleared drug, device, or biologic that a clinician can administer as routine treatment. If a site uses our material to treat patients outside a study protocol and its governing authorisation, that use is outside this policy, full stop — regardless of the clinician's license or the patient's consent.

Who we supply, and who we don't

We supply institutions, laboratories, and licensed professionals conducting research or clinical investigation under proper authorisation. We do not sell to the public, and we do not open accounts for individuals ordering on their own behalf. We also do not supply material for routine or off-label patient treatment — any use of the material in a patient outside an active study protocol and its governing IND, IRB/IEC approval, or national authorisation, even at a licensed clinic. If that's what an order is for, we decline it, whatever credentials come attached to it.

Before anything ships

A receiving site has to confirm, in writing, before we ship: that it is licensed or otherwise qualified to hold and use the material, and that it will use the material only within the rules that apply where it operates — under the specific IND, IRB/IEC approval, or national authorisation covering that work. We keep that confirmation on file. A verbal assurance, a business card, or an impressive website is not a substitute for it, and we ask for it before we ship, not after.

What travels with the material

Every shipment leaves with the certificate of analysis for that specific lot, its batch record, and written cold-chain and handling instructions — plus the name of the person here who answers for it. A site that receives material from us has, in hand, everything it needs to know what it's holding and how to keep it that way.

Orders we decline

We turn down orders that fall outside this policy: an individual ordering for personal use, a site that can't or won't put its authorisation in writing, a request that reads as sourcing for resale or for treatment outside a study, or any order where the stated use doesn't match the regulatory pathway behind it. Declining an order isn't a judgment call we agonize over — it's what this policy is for.

If a site misuses material

Auvum reserves the right to refuse or discontinue supply to any site found to be misusing material — using it outside the authorisation it gave us in writing — or misrepresenting its regulatory status to us or to anyone else. That applies to sites we already supply as much as new ones. Being an existing customer doesn't grandfather a site past this policy.

Questions about qualifying

If you run a lab, an institution, or a clinical investigation and aren't sure whether your paperwork qualifies, ask before you order — contact us and describe the authorisation you're working under. That conversation costs nothing, and it saves everyone the trouble of an order we'd have to decline anyway.

Effective September 15, 2026.