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FDA US Registration Agent

FDA Agents Inc.

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U.S. Agent and Registration of Food Facilities Worldwide
for the United States Food and Drug Administration
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U.S. FDA Agent Terms of Registration and US Agent Services

 

Terms of Registration and US Agent Services
under regulations of the United States Food and Drug Administration

This Terms of Registration and US Agent Services Agreement (the "Agreement") constitutes the terms under which FDA AGENTS, INC. (the "Agent") is to provide registration and U.S. Agent services for the foreign food facility on whose behalf Agent is paid for such services (called collectively along with the Owner, Operator or Agent In Charge the "Customer"). Agent is a United States based entity authorized to serve as the United States Agent for foreign food facilities pursuant to U.S. Food and Drug Administration Regulations and the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, Section 305 (the "Law"). Customer is a food or beverage facility desiring to (a) register with the U.S. Food and Drug Administration (the "FDA"), and (b) appoint a U.S. Agent. The "Effective Date" of this Agreement shall be that date on which the payment(s) due to Agent under Section 5 below has been paid.

In consideration of the terms, conditions and promises shown below, Agent and Customer agree:

  1. Appointment as U.S.Agent and FDA Registration: On behalf of and for the benefit of Customer, Customer hereby apppoints Agent to serve as Customer's U.S. Agent. Agent further agrees to assist Customer to register with the FDA. Customer agrees to (i) give Agent all information necessary for Agent to complete its duties under this Agreement, (ii) cooperate fully with Agent in the performance of Agent's duties, and (iii) pay to Agent the fee(s) shown in Section 5 below. Depending on Customer's needs during the term of this Agreement, Customer shall pay to Agent the fee for filing amendments/updates as may be required by Customer from time to time, as required by the Law. Customer hereby appoints Agent as its submitter of the FDA Registration Form with authority to submit the Registration Form to the FDA.
  2. Term of this Agreement: This Agreement begins on the Effective Date and (a) for Customers that have chosen the one-year FDA Registration, ends three hundred sixty five (365) days after the Effective Date; or (b) for Customers that have chosen to take advantage of the discounts offered under either the two-year or the four-year multi-year FDA registration option, this Agreement shall end on their appropriate anniversary date (e.g. two years or four years). This Agreement shall no longer be in effect, and Agent will no longer serve as Customer's U.S. Agent, unless Customer renews this Agreement with Agent and pays the renewal fee prior to the end-date of this Agreement. Failure at any time to pay timely Agent's registration or renewal fees shall entitle Agent to terminate this Agreement, cancel Customer's US FDA Registration and cancel Customer's US FDA Registration Number, and Customer (expressly including for emphasis its Owner, Operator r Agent in Charge, hereby authorizes Agent to cancel Customer's US FDA Registration and US FDA Registration Number.
  3. Specific Duties of Agent: To complete Agent's duties under the Law and this Agreement, Agent shall:
  4. Specific Duties of Customer: In order for Agent to properly perform its duties for the benefit of Customer per this Agreement, Customer shall:
  5. Charges for FDA Representation. In consideration of Agent performing its duties described in Section 3 above, Customer shall pay Agent an annual fee; the precise amount of Customer's fee is based on the fee schedule set forth on Agent's website and shall be the amount which Customer selects (depending on the number of years selected), but in any event shall not be less than Four Hundred Ninety-Nine Dollars (499.00 usd) for registration and Two Hundred Ninety-Nine Dollars (299.00 usd) for annual renewal of registration and Agent services. Customer acknowledges and agrees that this fee is fully earned and non-refundable upon the registration of Customer with the FDA and Customer being issued an FDA Registration Number. Customer agrees that in the event any payment by Customer is declined for any reason or if Agent is not paid its fee in full for any reason, whether such fee is for the initial registration or any renewal required by Agent, Agent shall cancel, and Agent is hereby authorized to do so by Customer without further notice or approval, the Customer's registration with the FDA, this Agreement shall then terminate, and that in such event, Agent will not serve any longer and effective immediately as Customer's U.S. Agent.
  6. Termination. Customer may terminate this Agreement at any time upon no less than ten (10) days' written notice to Agent, and upon such termination, Agent will notify the FDA of such termination within ten (10) days of receipt of such notice. Agent may terminate this Agreement if Customer is in default of any terms of this Agreement. Except if terminated solely due to the FDA not issuing an FDA Registration Number to Customer, the fee set forth in Section 5 above shall be and is fully earned and non-refundable to Customer no matter how or when this Agreement may be or is terminated. Upon any Customer default of any term of this Agreement, Agent will give Customer five (5) days written notice by email or fax on file of any such default and Agent's intent to terminate this Agreement and cancel Customer's US FDA Registration and US FDA Registration Number. If Customer does not renew this Agreement or is in default of any term hereof, Customer (Owner, Operator or Agent in Charge) hereby authorizes Agent to terminate this Agrement, cancel Customer's US FDA Registration and cancel Customer's US FDA Registration Number.
  7. Confidentiality. Agent specifically agrees to maintain (a) all information received from Customer, including all information included on the Form, and (b) any information, notices, communications, and demands (hereinafter collectively "Customer Information") confidential, and shall not reveal or disclose any Customer Information to any other person, company, broker, or any other third party entity, without the express written consent of Customer, except to the FDA or pursuant to governmental regulation or court order.
  8. Exclusions from Agent's Duties. Customer agrees that except for the items specifically set forth in Section 3. above, Agent has no additional duties or responsibilities on behalf of Client, including without limitation:
  9. Limitation of Liability. To the maximum extent allowed by law, Agent shall not be liable for a return of Agent's fee, or for any incidental, consequential, special, general or punitive damages, injury, loss or ensuing liability, whether foreseen or unforeseen, arising out of or related to, directly or indirectly, (a) any failure of the FDA to accept and approve Customer's application for registration (b) proceedings to terminate Customer's FDA Registration, (c) the failure of any product of Customers to be allowed entry into the United States or (d) for any other reason not directly and solely due to the breach by Agent of its express duties under this Agreement. In no event shall Agent's liability to Customer or any other entities, whether such action is in contract or in tort, or arising out of or related to, directly or indirectly, the Customer-Agent relationship or hereunder, be greater than Agent's fee that was paid by Customer under Section 5 above.
  10. Method and Addresses for Notices: Any notice or other written communication shall only be effective if delivered as follows:
  11. If by Land/Air Mail Service: If to Agent, then to the Mailing Address set forth on the Contact Page of Agent's website (www.fdaagents.com); if to Customer, then to the Mailing Address set forth on the FDA Form.
    If by Fax/Facsimile: If to Agent, then to: +1 858-712-1998 (USA)
    If to Customer, then to the fax number set forth on the FDA Registration Form.
    If by Internet/E-mail: If to Agent, then to legal@fdaagents.com
    If to Customer, then to the E-mail address set forth in Agent's files for Customer.
  12. Miscellaneous.

[END OF AGENT REPRESENTATION AGREEMENT]