FDA Compliance Form

FDA COMPLIANCE FORM

This FDA Compliance Form (the Agreement) is entered into as of Effective Date: by and between Manufacturer Name: with principal place of business at (Manufacturer), and Distributor/Recipient Name: with principal place of business at (Recipient).

RECITALS

WHEREAS, Manufacturer is engaged in the manufacture, packaging and labeling of the Product described below and represents that such activities occur under quality systems and processes intended to comply with the Federal Food, Drug, and Cosmetic Act and applicable federal regulations, including current Good Manufacturing Practices;

WHEREAS, Recipient intends to distribute, market or otherwise place the Product into interstate commerce and requires documented assurances from Manufacturer concerning regulatory compliance, record accessibility, adverse event reporting and recall cooperation;

WHEREAS, the parties desire to set forth in writing their respective certifications, obligations and procedures to ensure compliance with applicable laws and to allocate responsibilities in the event of nonconformance, recall, or regulatory action;

NOW, THEREFORE, in consideration of the mutual covenants and agreements contained herein, the parties agree as follows:

1. DEFINITIONS

For purposes of this Agreement, the following terms have the following meanings:

"Product" means the article(s), device(s), drug(s) or combination product(s) subject to this Agreement identified as Product Name: , Product Code / SKU: , and further described as:

2. CERTIFICATIONS AND REPRESENTATIONS

Manufacturer hereby certifies and represents that:

1. Manufacturing Processes: All manufacture, storage, labeling and distribution of the Product at Manufacturing Location: are conducted in conformity with the Federal Food, Drug, and Cosmetic Act and applicable federal regulations, including current Good Manufacturing Practices (cGMP).
2. Regulatory Status: To Manufacturer's best knowledge, the Product is not adulterated or misbranded as defined in applicable law, and, where applicable, required premarket notifications, clearances or approvals have been obtained and are summarized here:
3. Registration and Listing: Manufacturer's establishment registration and product listings, if required, are current and accurate. FDA Establishment/Registration Number (if applicable):

3. MANUFACTURING AND QUALITY OBLIGATIONS

Manufacturer shall manufacture, inspect and release Product lots in accordance with written specifications and quality agreements. Manufacturer shall ensure that each lot bears accurate labeling and lot identification (Lot Number: ; Manufacture Date: ).

Manufacturer confirms the following (check applicable):
cGMP in place Quality System / QMS maintained Sterility or other performance claims validated

4. RECORDS, INSPECTIONS AND AUDIT RIGHTS

Manufacturer shall maintain records, batch production records, test data and distribution records relating to the Product for a period of Records Retention Period (years): years, or such longer period as required by law. Upon reasonable notice, Manufacturer shall permit Recipient, or an independent auditor engaged by Recipient, to inspect relevant records and facilities during normal business hours, subject to customary confidentiality safeguards.

5. ADVERSE EVENTS, COMPLAINTS AND REPORTING

Manufacturer shall notify Recipient within Notification Timeframe (hours): hours of becoming aware of any serious adverse event, reportable complaint, or potential reportable event as defined by applicable law. Manufacturer shall cooperate in preparation and submission of required regulatory reports and provide to Recipient copies of all communications with regulatory authorities concerning the Product.

6. RECALLS AND CORRECTIVE ACTIONS

In the event that Product is or may be the subject of a recall, market withdrawal, or correction, the parties shall cooperate fully. Manufacturer shall promptly notify Recipient of a recall scenario and, unless otherwise agreed in writing, Manufacturer shall be responsible for execution of the recall or corrective action plan and associated costs to the extent caused by Manufacturer's nonconformity. The parties agree to coordinate communications to regulators and the public so as to ensure consistency and regulatory compliance.

7. INDEMNIFICATION

Manufacturer shall indemnify, defend and hold harmless Recipient and its officers, directors and agents from and against any third party claims, liabilities, losses, damages, costs and expenses (including reasonable attorneys' fees) arising out of Manufacturer's breach of its warranties or obligations under this Agreement, negligent acts or omissions, or failure to comply with applicable law. Indemnity Limit (if any): .

8. CONFIDENTIALITY

Unless otherwise agreed in a separate confidentiality agreement, each party shall treat as confidential all non-public information disclosed by the other party in connection with this Agreement, including quality and manufacturing records, and shall not disclose such information except as required by law or to its professional advisors bound by confidentiality obligations.

9. TERM AND TERMINATION

This Agreement shall commence on the Effective Date and continue until terminated by either party upon Termination Notice Period (days): days' written notice. Either party may terminate immediately for cause if the other party materially breaches its obligations and fails to cure within Cure Period (days): days after written notice.

10. NOTICES

All notices shall be in writing and delivered by certified mail, courier, or email to the addresses set forth above, and shall be effective upon receipt.

11. AMENDMENTS; WAIVER; COUNTERPARTS

No amendment or modification of this Agreement shall be effective unless in writing and signed by authorized representatives of both parties. Failure to enforce any provision shall not constitute a waiver of that provision. This Agreement may be executed in counterparts, each of which shall be deemed an original and all of which together shall constitute one and the same instrument.

12. GOVERNING LAW; ENTIRE AGREEMENT; SEVERABILITY

This Agreement shall be governed by and construed in accordance with the laws of the State of , without regard to its conflict of laws rules. This Agreement, together with any exhibits or attachments, constitutes the entire agreement between the parties relating to its subject matter and supersedes all prior proposals and agreements. If any provision of this Agreement is held invalid or unenforceable, the remainder of the Agreement shall remain in full force and effect.

13. MISCELLANEOUS PROVISIONS

Each party shall perform its obligations hereunder in a manner consistent with applicable law and applicable regulatory guidance. Neither party shall assign this Agreement without the prior written consent of the other, except to a successor in interest in connection with a merger or sale of substantially all assets.

SIGNATURES

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