Effective Date: 07/07/2026

Last Updated: 07/07/2026

These Terms and Conditions (“Terms”) govern access to and use of www.dux.bio (the “Site”) and the purchase of products distributed by Dux Bio, Inc. and its affiliates (“Dux Bio,” “we,” “us,” or “our”), including DuxCord™, NativeMUSE™, and other human cell and tissue products (collectively, the “Products”). By accessing the Site, submitting an order, or otherwise using our Services, you (“Customer,” “you,” or “your”) agree to be bound by these Terms. If you do not agree, do not access the Site or purchase Products.

1. Eligibility and Authorized Purchasers

The Products are human cell, tissue, and cellular and tissue-based products (“HCT/Ps”) intended solely for use by licensed physicians, clinics, hospitals, and other qualified healthcare providers or entities legally authorized to receive, handle, and administer such products in their jurisdiction (“Authorized Purchasers”). By placing an order, you represent and warrant that:

• You are an Authorized Purchaser acting within the scope of your professional license and applicable law;
• You will use, store, and administer the Products in compliance with all applicable federal, state, local, and international laws, including FDA regulations governing HCT/Ps under 21 C.F.R. Part 1271 and, where applicable, current Good Tissue Practice (cGTP) requirements;
• You have independently evaluated the suitability of the Products for your intended clinical or research use; and
• You will not resell, redistribute, or transfer Products except in compliance with applicable law and any distribution agreement with Dux Bio.

Dux Bio reserves the right to request proof of licensure, accreditation, or other credentials prior to accepting any order, and to refuse or cancel orders from purchasers who do not meet these requirements.

2. Product Information and Regulatory Status

Dux Bio Products are regulated solely under Section 361 of the Public Health Service Act and 21 C.F.R. Part 1271 as minimally manipulated HCT/Ps intended for homologous use, and have not been approved, cleared, or licensed by the U.S. Food and Drug Administration (“FDA”) as a drug, device, or biologic under a Biologics License Application (BLA). No claim is made that the Products cure, treat, or prevent any disease. Product descriptions, specifications, and clinical or scientific literature referenced on the Site are provided for informational purposes only and do not constitute medical advice or a guarantee of clinical outcome. It is the sole responsibility of the Authorized Purchaser to determine the appropriateness of any Product for a particular patient or use, and to obtain any required informed consent.

3. Orders, Pricing, and Payment

All orders are subject to acceptance and product availability. Prices are as quoted at the time of order and are subject to change without notice prior to acceptance of an order. Payment terms will be specified on the applicable invoice or order confirmation. Dux Bio reserves the right to require payment in advance of shipment, particularly for first-time purchasers. You are responsible for all applicable taxes, duties, and fees associated with your order, other than taxes based on Dux Bio’s net income.

4. Shipping, Handling, and Chain of Custody

Due to the biological nature and cryopreservation requirements of the Products, shipping is arranged using validated cold-chain logistics providers, and delivery windows and handling instructions provided at the time of shipment must be followed precisely. Customer is responsible for:

• Ensuring appropriate personnel and storage equipment (e.g., liquid nitrogen or ultra-low temperature storage, as applicable) are available and functioning prior to delivery;
• Inspecting shipments immediately upon receipt for temperature excursion indicators, packaging integrity, and accompanying documentation; and
• Promptly reporting any suspected temperature excursion, damage, or discrepancy to Dux Bio within twenty-four (24) hours of delivery, as further described in Section 5.

Title and risk of loss for Products pass to Customer upon delivery to the carrier, except where otherwise stated in a separate distribution agreement.

5. Returns, Cancellations, and Refunds

ALL SALES OF CRYOPRESERVED TISSUE PRODUCTS ARE FINAL. PRODUCTS THAT HAVE BEEN CRYOPRESERVED AND RECEIVED BY CUSTOMER MAY NOT BE RETURNED, EXCHANGED, OR REFUNDED FOR ANY REASON, INCLUDING BUT NOT LIMITED TO CHANGE OF MIND, OVER-ORDERING, OR FAILURE TO USE PRODUCT PRIOR TO EXPIRATION.

Due to the perishable, single-use, and cold-chain-dependent nature of cryopreserved human cell and tissue Products, and applicable regulatory restrictions on the redistribution of previously shipped HCT/Ps, Dux Bio does not accept returns, exchanges, or issue refunds once a cryopreserved Product has left our facility and been received by Customer, regardless of whether the Product has been used, opened, or thawed. This no-returns policy applies without exception once the Product is delivered, except as expressly provided in Section 5.1 below.

5.1 Verified Shipping Defects

The sole exception to the no-returns policy in this Section 5 is for Products that arrive with a verified temperature excursion outside validated shipping parameters, physical damage to primary packaging occurring in transit, or a confirmed shipment error (e.g., incorrect product or quantity shipped), provided that:

• Customer notifies Dux Bio in writing within twenty-four (24) hours of delivery;
• Customer provides the temperature data logger record, photographs, and/or other documentation reasonably requested by Dux Bio; and
• The affected Product has not been used, thawed, or administered.

If a claim is verified by Dux Bio in its reasonable discretion, Dux Bio’s sole obligation and Customer’s exclusive remedy will be, at Dux Bio’s option, replacement of the affected Product or issuance of a credit or refund for the affected units only. Claims submitted after twenty-four (24) hours, or involving Product that has been thawed, used, or administered, will not be honored.

5.2 Order Cancellations

Orders may be canceled without charge only prior to shipment. Once a Product has entered fulfillment or shipping, the order is subject to the no-returns policy described above upon delivery.

6. Product Storage, Handling, and Expiration

Customer is solely responsible for the proper storage, handling, and administration of Products following delivery, in accordance with the instructions for use and labeling accompanying each Product. Dux Bio is not responsible for any loss of potency, viability, or efficacy resulting from improper storage, handling, thawing, or administration by Customer or its personnel after delivery. Products should not be used after the labeled expiration date.

7. Intellectual Property

The Site, including all text, graphics, logos, trademarks (including DuxCord™ and NativeMUSE™), product literature, and other content, is owned by or licensed to Dux Bio and is protected by applicable intellectual property laws. You may not reproduce, distribute, modify, or create derivative works from any content on the Site without our prior written consent, except as necessary to use the Site for its intended purpose or to share Product information with patients as part of informed consent.

8. Disclaimer of Warranties

EXCEPT AS EXPRESSLY SET FORTH IN AN APPLICABLE CERTIFICATE OF ANALYSIS OR WRITTEN PRODUCT SPECIFICATION PROVIDED BY DUX BIO, THE PRODUCTS AND THE SITE ARE PROVIDED “AS IS” AND “AS AVAILABLE,” WITHOUT WARRANTIES OF ANY KIND, WHETHER EXPRESS, IMPLIED, OR STATUTORY, INCLUDING WITHOUT LIMITATION IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND NON-INFRINGEMENT. DUX BIO DOES NOT WARRANT THAT THE PRODUCTS WILL ACHIEVE ANY PARTICULAR CLINICAL OUTCOME, AND CUSTOMER ACKNOWLEDGES THAT OUTCOMES MAY VARY BY PATIENT.

9. Limitation of Liability

TO THE MAXIMUM EXTENT PERMITTED BY LAW, DUX BIO AND ITS AFFILIATES, OFFICERS, DIRECTORS, EMPLOYEES, AND SUPPLIERS WILL NOT BE LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, OR PUNITIVE DAMAGES, OR ANY LOSS OF PROFITS, REVENUE, DATA, OR GOODWILL, ARISING OUT OF OR RELATED TO THE PRODUCTS, THE SITE, OR THESE TERMS, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. DUX BIO’S TOTAL CUMULATIVE LIABILITY ARISING OUT OF OR RELATED TO THESE TERMS OR ANY ORDER WILL NOT EXCEED THE AMOUNT PAID BY CUSTOMER FOR THE SPECIFIC PRODUCT(S) GIVING RISE TO THE CLAIM.

10. Indemnification

You agree to indemnify, defend, and hold harmless Dux Bio and its affiliates, officers, directors, employees, and agents from and against any claims, liabilities, damages, losses, and expenses (including reasonable attorneys’ fees) arising out of or related to: (a) your use, storage, handling, or administration of any Product; (b) your breach of these Terms or any representation or warranty herein; (c) your violation of applicable law, including FDA regulations governing HCT/Ps; or (d) any claim brought by or on behalf of a patient in connection with a Product administered by you or your organization.

11. Compliance with Laws

Customer is solely responsible for ensuring that its purchase, storage, marketing, and use of the Products complies with all applicable federal, state, local, and international laws and regulations, including those of the jurisdiction in which the Products are received and used. Dux Bio makes no representation regarding the legality of Product use in any specific jurisdiction outside the scope of its own regulatory positioning, and Customer should consult its own regulatory counsel as needed.

12. Confidentiality

Any pricing, technical, or business information disclosed by Dux Bio that is marked confidential or would reasonably be understood to be confidential (including unpublished product specifications and pricing) shall be held in confidence by Customer and not disclosed to third parties without Dux Bio’s prior written consent, except as required by law.

13. Termination

Dux Bio may suspend or terminate your access to the Site or ability to place orders at any time, with or without cause or notice, including for suspected violation of these Terms, failure to meet Authorized Purchaser requirements, or non-payment. Sections 5 through 10 and any other provisions that by their nature should survive will survive termination of these Terms.

14. Governing Law and Dispute Resolution

These Terms are governed by the laws of the State of [INSERT STATE], without regard to its conflict of laws principles. Any dispute arising out of or relating to these Terms or any order shall be resolved through the process described in [INSERT: binding arbitration under (name of arbitration body) / the exclusive jurisdiction of the state and federal courts located in (county/state)], and each party waives any right to a jury trial or to participate in a class action, to the extent permitted by applicable law.

15. Changes to These Terms

Dux Bio may revise these Terms from time to time. The revised Terms will be posted on the Site with an updated “Last Updated” date and will apply to orders placed after the effective date of the revision. Your continued use of the Site or submission of an order after changes become effective constitutes acceptance of the revised Terms.

16. Miscellaneous

These Terms, together with any applicable order confirmation, invoice, or separate written distribution agreement, constitute the entire agreement between you and Dux Bio regarding the subject matter herein and supersede any prior agreements. If any provision of these Terms is held unenforceable, the remaining provisions will remain in full force and effect. Dux Bio’s failure to enforce any provision shall not be deemed a waiver of that provision. You may not assign these Terms without Dux Bio’s prior written consent; Dux Bio may assign these Terms without restriction.

17. Contact Us

Questions about these Terms, an order, or a shipping issue should be directed to:

Dux Bio, Inc.
5020 Thoroughbred Lane
Brentwood, TN 37027

Email: orders@dux.bio

Phone: (‭865) 323-4740‬

Note: This document is a general-purpose template and has not been reviewed by a licensed attorney. Because Dux Bio distributes FDA-regulated human cell and tissue products, we recommend that these Terms be reviewed by qualified healthcare regulatory and commercial counsel prior to publication, with particular attention to state-specific consumer protection and “no refund” disclosure requirements (some states require conspicuous disclosure of no-return policies at the point of sale), enforceability of liability limitations and arbitration clauses in your chosen governing-law state, and consistency with any separate distribution or supply agreements you have with individual customers.