FDA Disclaimer Form

FDA DISCLAIMER FORM

This FDA Disclaimer Form is entered into as of Date: , by and between Provider Name: , Provider Address: , and Recipient Name: , Recipient Address: . The parties agree as follows:

Recitals

WHEREAS, Provider develops, manufactures, markets or supplies the product(s) described as:

WHEREAS, Provider desires to distribute, market, or otherwise make available the product(s) to Recipient and Recipient desires to distribute, resell or otherwise use the product(s) subject to the terms of this Form; and

WHEREAS, the parties acknowledge that certain statements or representations related to the product(s) may be construed to concern the U.S. Food and Drug Administration, its approval, evaluation, or endorsement, and the parties wish to establish clear disclaimers and responsibilities with respect thereto.

NOW, THEREFORE

In consideration of the mutual covenants contained herein and other good and valuable consideration, the receipt and sufficiency of which are acknowledged, the parties agree as follows.

1. Acknowledgment of FDA Status

Recipient acknowledges and agrees that any statements, claims or representations made by Provider or by Recipient regarding the product(s) have not been evaluated, approved, cleared, or endorsed by the Food and Drug Administration (FDA), unless an express written statement signed by both parties so states. Recipient shall not represent or imply FDA approval, clearance, or endorsement of the product(s) except as expressly authorized in writing by Provider.

2. Required Disclaimer Language

Recipient agrees to display the following disclaimer on all product packaging, advertising, promotional materials and websites where product(s) are offered for sale or distribution, in the form and placement required by Provider:

3. Representations and Warranties

Provider represents and warrants that to the best of its knowledge the labeling and promotional copy it supplies to Recipient does not knowingly contain false or misleading statements regarding the regulatory status of the product(s). Recipient represents and warrants that it will not alter required disclaimer language or make affirmative claims of FDA evaluation or approval unless Provider supplies express written authorization signed by an officer of Provider.

4. Indemnification

Recipient shall indemnify, defend and hold harmless Provider and its officers, directors, employees and agents from and against any and all claims, liabilities, losses, damages, penalties, fines, costs and expenses (including reasonable attorneys' fees) arising out of or relating to Recipient's failure to include or maintain the required disclaimer language, any misrepresentations to customers or regulators by Recipient, or Recipient's violation of applicable law in marketing or distributing the product(s).

5. Limitation of Liability

Except for liability arising from willful misconduct or gross negligence, neither party shall be liable to the other for incidental, consequential, special or punitive damages, and each party's aggregate liability under this Form shall not exceed the total amount paid by Recipient to Provider for the product(s) giving rise to the claim during the twelve (12) months preceding the event giving rise to liability.

6. Compliance with Laws

Each party shall comply with all applicable federal, state and local laws, rules and regulations in connection with its performance under this Form. Recipient shall maintain records demonstrating compliance with the requirements of this Form and shall produce such records to Provider upon reasonable request.

7. Audit and Corrective Action

Provider reserves the right to audit Recipient's marketing materials and product labeling upon reasonable notice. If Provider identifies noncompliant materials, Recipient shall promptly, and at its own expense, correct such materials and implement corrective measures satisfactory to Provider.

8. Notices

All notices required or permitted under this Form must be in writing and delivered to the addresses set forth below by certified mail, overnight courier, or hand delivery. Notice is effective upon receipt.

9. Amendments; Waiver

No amendment to this Form will be effective unless in writing and signed by authorized representatives of both parties. No waiver of any provision hereof shall be effective unless in writing and signed by the waiving party, and no single waiver will constitute a continuing waiver of the same provision.

10. Counterparts; Electronic Signatures

This Form may be executed in counterparts, each of which shall be deemed an original and all of which together shall constitute one instrument. Signatures transmitted by electronic means (including facsimile or PDF) shall be effective to bind the signing party.

11. Governing Law

This Form shall be governed by and construed in accordance with the laws of the State of , without regard to choice-of-law principles that would apply the laws of another jurisdiction.

12. Entire Agreement; Severability

This Form constitutes the entire agreement between the parties with respect to the subject matter hereof and supersedes all prior and contemporaneous agreements, understandings, negotiations and discussions, whether oral or written. If any provision of this Form is held to be invalid or unenforceable under any applicable statute or rule of law, that provision will be enforced to the maximum extent permissible and the remaining provisions will remain in full force and effect.

13. Certification

By signing below, each party certifies that it has the authority to enter into this Form, that the information provided in this Form is true and correct to the best of its knowledge, and that it understands and accepts the disclaimers, obligations and limitations set forth herein.

Acknowledgments

Recipient acknowledges that product claims have not been evaluated by the FDA.

Recipient will not represent or imply FDA endorsement or approval of the product(s).

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