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FDA Agents

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

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/or U.S. Agent services for the foreign food, beverage, medical device or OTC drug 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, beverage, medical device or drug facilities pursuant to U.S. Food and Drug Administration Regulations, the FFD&C Act and the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, Section 305 (the "Law"). Customer is a food,beverage, medical device or drug facility desiring to (a) register with the U.S. Food and Drug Administration (the "FDA"), (b) list its product(s) and (c) 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 under the Law. Agent 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 and promptly 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 and to communciate with, by and between US FDA, Agent and/or Customer.
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 US Agent renewal fee prior to the end-date of this Agreement. Failure at any time to pay timely Agent's registration or US Agent renewal fees shall entitle and authorize 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 or 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:
• Complete and submit to the FDA a properly completed registration form, with all information as provided by Customer, including Customer's appointment of Agent as its U.S. Agent and Agent's consent to serve as Customer's U.S. Agent;
• Upon receipt of proof from the FDA of the completed FDA registration, transmit to Customer its FDA Registration Number;
• Submit to the FDA a written notification of any change to Customer's facility or to the information previously provided to the FDA by the Customer in its Form, as required by the Law (for example, a change of location, ownership, name, or type of product produced by Customer's facility), all as requested by Customer in writing;
• Submit to the FDA a cancellation of FDA registration and of FDA Registration Number, or directly cancel, should Customer cancel (as may be requested by Customer) or should Customer fail to pay timely and in full any annual US Agent renewal fee of Agent;
• Accept all FDA notices and communications received for Client, and promptly transmit the notice and communications to Customer;
• Strictly maintain all Customer confidentiality, as discussed in Section 7 below.
4. Specific Duties of Customer: In order for Agent to properly perform its duties for the benefit of Customer per this Agreement, Customer shall:
• Accurately and fully complete the regsitration, listing and US Agent designation applications, including any revisions or modifications as might be required for the FDA to approve the Form;
• Notify Agent of any change to Customer's facility or to the information previously provided to the FDA that requires filing of amendments with the FDA, or filing a Notice of Cancellation, as required under the Law;
• Provide Agent with an accurate, up-to-date list of at least one contact person for Customer, including their name, address, E-mail address (if any), facsimile number (if any), and telephone number;
• Within the time required by the Law or the FDA, provide a written response to any FDA inquiry, notice or communication and to cooperate fully with any FDA or U.S. government order or request;
• Provide Agent with the name, address, telephone number and contact person of their export broker (if any) and import broker (if any);
• Pay Agent's fee(s) in full for the initial FDA Registration and U.S.Agent service in the amount charged by Agent from time to time, and to pay Agent's fee(s) in full for any and all renewals of the US Agent services, all as may be required from time to time by Agent.
• If Customer requires the filing of any changes, amendments or cancellations with the FDA, to pay Agent's fee for that service; and
• Cooperate fully with Agent as Agent may consider in its sole and absolute discretion necessary to allow Agent to perform its duties under this Agreement and under the Law.
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). 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 US Agent 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 and registration number with the FDA, this Agreement shall then terminate, and that in such event, Agent will not serve any longer 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. 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:
• any duty whatsoever concerning any violation, deficiency, or other matter pertaining to the production, storage, transport, or importation of any food products into the United States;
• any notification made or required to be made or documentation required to be maintained by or on behalf of Customer (and its brokers and agents) for or to the FDA, the United States Customs Department or any other governmental agency, including, without limitation, any "prior notification" or "prior notice" requirements currently in effect or which may be implemented in the future;
• any additional duties beyond those required to be furnished by the Law on the Effective Date, it being agreed that in the event any such additional duties of Agent are imposed by any amendment to the Law after the Effective Date, Agent and Customer will agree to reasonable compensation for Agent to perform such additional duties.
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.
• Place of Performance. This Agreement is entered into in the State of Texas, United States of America. Agent's services performed per this Agreement will be performed and completed in the State of Texas, United States of America. Any action based on this Agreement shall be brought in the City of Bandera, State of Texas, USA.
• Choice of Law. This Agreement will be governed under the laws of the State of Texas, United States of America.
• Defend and Indemnify. In the event any proceedings, claims, actions or judgments (judicial or otherwise) are brought or threatened against Agent, its employees, officers, directors, shareholders or independent contractors, arising out of or related to, directly or indirectly, this Agreement or the duties of the parties under this Agreement or under the Law, including due to the actions or inactions of Customer, including the accuracy and truthfulness of all items and information included by Customer on the Registration Form (collectively "Claims"), Customer agrees to and shall defend, indemnify and hold Agent, its employees, officers, directors, shareholders and independent contractors harmless from such Claims, including damages, injury and the reasonable legal fees and costs incurred by those indemnitees in defending against or paying any such Claims. This defense and indemnity will survive the termination of this Agreement.
• Authority. The persons signing this Agreement warrant that they have the legal authority to sign on behalf of the person or entity being signed for.
• Modification. This Agreement may be modified or amended by Agent from time to time, in its discretion. Customer may not modify this Agreement.
• Entire Agreement. This written Agreement includes the entire agreement between Agent and Customer, and no other prior, contemporaneous, or verbal or written agreement shall have any effectiveness, or be deemed valid, as between the parties. Customer warrants, represents and agrees that it has reviewed this Agreement and understands and agrees to its terms.
• Electronic Acceptance. Customer's agreement to this Agreement shall be shown by Customer clicking the "Customer Agrees and Accepts" button on the Payment Page and/or by Customer's payment to Agent of any part of Agent's fee. Agent's agreement to this Agreement is shown by acceptance of Customer's payment set forth in Section 5 above.

[END OF AGENT REPRESENTATION AGREEMENT]