Disclaimer

Formulations available through Vivion.One™ are manufactured by independent FDA-registered laboratories and are not FDA-approved or intended to diagnose, treat, cure, or prevent any disease. They are available only to licensed healthcare professionals, for use within their scope of practice and applicable law. Vivion.One™ is a neutral transactional platform and does not provide medical advice or clinical guidance.

The Vivion.One Approach

Your License. Your Platform.

Provider Registration

Vivion.One™ Mutual Non-Disclosure Agreement (NDA)

This Agreement is entered into as of [Insert Date] by and between Vivion.One Inc. (“Vivion.One”) and [Insert Recipient Name] (“Recipient”), collectively referred to as the “Parties.”

1. Purpose

The Parties wish to protect certain confidential, proprietary, strategic, or regulatory information shared in connection with Vivion.One’s platform operations, vendor relationships, technical infrastructure, compliance positioning, and business strategy.

2. Definition of Confidential Information

“Confidential Information” includes, but is not limited to:

Platform structure, ordering workflows, routing logic, and internal naming conventions
Business development strategy, vendor lists, platform-partner agreements
Regulatory frameworks, disclaimers, legal positioning documents
Financial models, pricing systems, and any unpublished materials

3. Obligations of Recipient

Recipient agrees to:

Maintain all Confidential Information in strict confidence
Use the information solely for evaluation or execution of services related to Vivion.One
Not disclose it to third parties without prior written consent
Return or destroy all materials upon request

4. Exclusions

Confidential Information does not include information that:

Was known prior to disclosure
Becomes public through no fault of the Recipient
Is lawfully obtained by Recipient from another source

5. No License or Ownership Transfer

This Agreement does not convey any right, license, or title in the Confidential Information. All information remains the property of the disclosing Party.

6. Term and Survival

This Agreement remains in effect for two (5) years from the Effective Date and obligations survive any termination.

7. Governing Law

This Agreement is governed by the laws of the State of Texas, without regard to its conflict of law principles.

FDA-Registered Labs

Manufacturing Standards & Source Transparency

Formulations available through the Vivion.One™ platform are manufactured by independent FDA-registered laboratories that operate under current Good Manufacturing Practices (cGMP) and applicable Human Cell and Tissue Establishment regulations. FDA registration applies to the facility, not to the individual formulations, and does not mean any formulation is approved, cleared, or licensed by the FDA.

These formulations are derived from ethically sourced umbilical cord tissue and are prepared under the lab’s internal standard operating procedures and quality systems. Any regulatory designation (for example, how a laboratory characterizes a formulation within its own compliance framework) is determined and documented by the laboratory itself. Vivion.One™ does not interpret designation pathways or make claims about the intended use, regulatory status, or clinical application of any formulation.

Vivion.One™ does not manufacture, alter, or claim ownership of the formulations. Each formulation is represented on the platform by a Platform-Designated™ identity for ordering purposes, allowing verified providers to submit ordering requests that are routed to the corresponding laboratory formulation without referencing proprietary lab formulation names.

Platform Use & Regulatory Disclosure

Vivion.One™ is a secure transactional platform that facilitates ordering access for verified and authorized licensed healthcare professionals to umbilical cord–derived formulations manufactured by independent FDA-registered laboratories.

Formulations are referenced on the platform using internal Platform-Designated™ identities solely to enable routing of ordering requests. Vivion.One™ does not manufacture, modify, repackage, relabel, store, or ship any formulations, nor does it claim ownership, clinical control, or regulatory authority over any formulation offered by an independent laboratory.

All formulations available through Vivion.One™ are produced by independent FDA-registered manufacturing facilities operating under cGMP. These preparations may contain naturally occurring components, including extracellular vesicles and growth factors, that are the subject of ongoing scientific and investigational interest. Formulations accessed through Vivion.One™ are not approved by the U.S. Food and Drug Administration (FDA) and are not intended to diagnose, treat, cure, or prevent any disease or medical condition. Any decision to use a formulation in human care must be made solely by the prescribing healthcare professional, within their scope of practice and in accordance with applicable laws, regulations, and—where required—appropriate investigational or oversight frameworks (such as IRB- or IND-governed use).

Vivion.One™ does not provide medical advice, clinical guidance, or training. Independent educational resources or peer-to-peer programs, where available, may be provided by third parties and are separate from the Vivion.One™ platform. All platform information is offered solely for professional informational purposes. Images are for illustrative use only and do not represent clinical outcomes or therapeutic claims.

Access to the Vivion.One™ platform requires professional registration, verification of licensure, and authorization prior to ordering. Formulations are not available for consumer purchase or unsupervised use.

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