Legal FDA Entry Form

LEGAL FDA ENTRY FORM

This Legal FDA Entry Form (the "Form") is entered into as of Day: Month: Year: , by and between Importer Name: (the "Importer"), and Authorized Entry Agent Name: (the "Agent").

RECITALS

WHEREAS, the Importer imports goods regulated by the United States Food and Drug Administration (FDA) and requires that entries, prior notices and related data and documentation required by federal law and administrative practice be prepared and submitted to the appropriate authorities; and

WHEREAS, the Agent is duly authorized, experienced and capable of preparing and submitting FDA entry data, including but not limited to prior notices, product registrations, product listings, establishment registrations and accompanying customs entry documentation (collectively, "Entry Services"); and

WHEREAS, the parties desire to set forth the terms under which the Agent will prepare, submit and certify FDA-related entry data on behalf of the Importer for shipments described in this Form.

NOW, THEREFORE

In consideration of the mutual covenants and agreements set forth below, the parties agree as follows:

1. DEFINITIONS

1.1 "FDA Entry" means any electronic submission, prior notice, registration, listing, declaration or other filing required by the FDA or its designees in connection with the importation of goods. "Entry Data" means all information, records, documentation, declarations, invoices, bills of lading, labels, product specifications, certificates of analysis and other materials provided by the Importer or generated by the Agent in connection with an FDA Entry.

2. SCOPE OF AUTHORIZATION

2.1 Appointment. The Importer appoints the Agent, and the Agent accepts such appointment, to prepare and submit Entry Data and to take all actions reasonably necessary to effect FDA Entries for the shipments described below and for any additional shipments as agreed in writing by the parties.

2.2 Authorized Shipments. This authorization applies to shipments described as follows:

3. AGENT OBLIGATIONS

3.1 The Agent shall prepare, sign and submit Entry Data in a timely and professional manner and shall use reasonable care to ensure that all submissions are accurate and complete based on the Entry Data provided by the Importer. The Agent's responsibilities include completion of required prior notices, registration and listing submissions, coordination with customs brokers and submission of supporting documentation where required.

3.2 The Agent shall promptly notify the Importer of any FDA inquiries, refusals, holds or requests for additional information and shall cooperate with the Importer in responding to such matters.

4. IMPORTER OBLIGATIONS

4.1 The Importer shall provide all Entry Data, documentation, certifications, product labels, specifications, certificates of analysis and any additional information necessary for the Agent to prepare and submit accurate filings. The Importer warrants that such information is true, accurate and complete in all material respects.

4.2 The Importer shall comply with applicable FDA laws, regulations and guidance, and shall not direct the Agent to submit any Entry Data that the Importer knows to be false or misleading.

5. FEES AND PAYMENT

5.1 The Importer shall pay the Agent fees for Entry Services as agreed between the parties. Unless otherwise agreed, fees payable to the Agent are non-refundable and due within thirty (30) days of invoice.

6. INDEMNIFICATION

6.1 The Importer shall indemnify, defend and hold harmless the Agent and its affiliates, officers, directors and employees from and against any and all claims, liabilities, losses, damages, costs and expenses (including reasonable attorneys' fees) arising out of or resulting from: (a) any Entry Data provided by the Importer that is inaccurate, incomplete or misleading; (b) the Importer's failure to comply with applicable FDA laws and regulations; or (c) the Importer's negligent or willful misconduct.

6.2 The Agent shall indemnify the Importer for liabilities arising solely from the Agent's gross negligence or willful misconduct in the performance of Entry Services; provided, however, that the Agent's total liability shall not exceed fees actually paid to the Agent for the specific Entry giving rise to the claim.

7. RECORDS AND AUDIT

7.1 Each party shall maintain, for a period of not less than three (3) years from the date of submission of an Entry, complete records relevant to such Entry. Each party shall permit the other party, upon reasonable notice, to audit records relevant to compliance with this Form.

8. NOTICES

All notices required or permitted under this Form shall be in writing and delivered to the addresses below by hand, overnight courier, or certified mail, return receipt requested, or by electronic mail with confirmation of receipt.

9. CONFIDENTIALITY

9.1 Each party shall treat Entry Data and any non-public business information exchanged under this Form as confidential and shall not disclose such information except (a) as necessary to perform obligations under this Form, (b) as required by law or governmental request, or (c) with the prior written consent of the disclosing party. A party required to disclose confidential information by law shall provide prompt notice to the other party where permitted so the other party may seek protective measures.

10. AMENDMENT; WAIVER; COUNTERPARTS

10.1 This Form may be amended only by a written instrument signed by both parties. No failure or delay by either party in exercising any right under this Form shall operate as a waiver. This Form may be executed in counterparts, each of which shall be deemed an original and all of which together shall constitute one instrument.

11. GOVERNING LAW; ENTIRE AGREEMENT; SEVERABILITY

11.1 Governing Law. This Form shall be governed by and construed in accordance with the laws of the jurisdiction specified below, without regard to conflict of law principles.

11.2 Entire Agreement. This Form constitutes the entire agreement between the parties with respect to its subject matter and supersedes all prior agreements and understandings, whether written or oral.

11.3 Severability. If any provision of this Form is held to be illegal, invalid or unenforceable in whole or in part, the remaining provisions shall continue in full force and effect to the fullest extent permitted by law.

12. CERTIFICATION

The undersigned representatives of the parties certify that they are authorized to execute this Form on behalf of their respective organizations, and that the information provided herein is true and correct. The Importer certifies that, to the best of its knowledge, the goods described in this Form comply with applicable FDA requirements and that any statements made to the Agent for purposes of entry are accurate.

Sign Now