FDA

BIOTERRORISM ACT - U.S. AGENCY AGREEMENT

 

THIS AGREEMENT,dated as of the *  day of *   between  [full company legal name]  located at *  [physical address of your company's home office], including its heirs, successors and assigns, a foreign corporation registered under the law of *  [country your comany is located in] (PRINCIPAL), and Deringer Logistics Consulting Group, A. N. Deringer Inc., its heirs, successors and assigns, a corportion existing under and by virtue of the laws of The State of Vermont, having a principal place of business located at 1 Lincoln Blvd, Ste 225, Rouses Point, NY 12979 ("AGENT");

WHEREAS PRINCIPAL is the owner, operator and/or agent-in-charge of a non-U.S. comapany engaged in the manufacturing, processing, packing, or holding food for human or animal consumption, for import into the United States (hereinafter referred to as "facility"), which is required to register with the Food and Drug Aministration ("FDA"), pursuant to the Regulations 21 C.F.R. Part 1, Subpart H ("Regulations"); and

WHEREAS, purusant to the Regulations a non-U.S. facility is required to have a U.S. AGENT;and

WHEREAS, AGENT is qulified to act in the capacity of U.S. agent and perform the services required under the Regulations; and

WHEREAS, the person executing this agreement on behalf of PRINCIPAL is authorized to do so by PRINCIPAL and certifies it is done in accordance with the laws of PRINCIPAL'S country;

NOW, THEREFORE, the parties agree as follows:

1. PRINCIPAL appoints AGENT, and AGENT hereby agrees, to serve as a U.S. agent of the PRINCIPAL, limited to those activities specified under the Regualtions.

2. On behalf of the PRINCIPAL, AGENT agrees to maintain a place of business domiciled in the United States and shall make itself available to receive communications from the FDA.

3. AGENT shall promptly advise PRINCIPAL of any requests and/or communications from FDA, in its capcacity as U.S. agent, by contacting PRINCIPAL at either the telephone number, facsimile number, e-mail address, or emergency phone number, set forth on Appendix "A", attached.

4. PRINCIPAL shall provide AGENT with an accurate, truthfully executed and certified Registration (FDA Form 3537), and/or any required amendments to such registration or cancellation of such registration (FDA Form 3537a).

5. AGENT shall not be required to certify or transmit registrations on behalf of the PRINCIPAL.

6. PRINCIPAL shall hold AGENT harmless from and will fully indemnify AGENT for any and all claims for penalties, and/or other charges or claims of whatever nature, including reasonable attorneys fees, assessed by FDA or other U.S. government agencies, in connection with AGENT'S services, directly or indirectly based upon, but not limited to, mistakes, errors, omissions or misrepresentations in information or data transmitted in reliance on Principal's representation.

7. This agreement shall be for a one year period from the date set forth above and shall continue in effect for one year periods, unless cancelled by either PRINCIPAL or AGENT, with or without cause, by providing 30 days written notice, by mail, e-mail or facsimile.

8. Disputes arising out of this agreement shall be submitted to arbitration, to be conducted in the State of VERMONT governed by and construed according to the laws of the state of VERMONT; the decision of the arbitrator (s) shall be final and biding on the parties hereto.

9. PRINCIPAL agrees to pay agent for its services and shall reimburse AGENT for all costs and reasonable expenses consistent with the attached schedule, (Annex I).

IN WITNESS WHEREOF,  the undersigned hereto executed this agreement on the day and year first written above.



AGENT   PRINCIPAL
[Below for Deringer only] [Below for Principal only]
DERINGER LOGISTICS CONSULTING GROUP Company Full Name:*
A.N. DERINGER,INC. Street Address:*
City,State/Province, Postal Code:*
By:* By:*
Typed Name:* Typed Name:*
Title:* Title:*

APPENDIX "A" TO AGENCY AGREEMENT

(*)FDA Regulations require that the PRINCIPAL provide a phone number and contact name, 24 hours a day, 7 days a week, unless the elective contained in 21 C.F.R. 1.232 (d) as covered by 21 C.F.R. 1.233 (c) is designated the AGENT will provide such service.

INSERT NAME OF PRINCIPAL :*  

In accordance with paragraph 3 of the attatched AGENCY AGREEMENT, following are the phone and facsimile numbers, and e-mail address, at which AGENT may contact PRINCIPAL. (PRINCIPAL WILL IMMEDIATELY NOTIFY AGENT OF ANY CHANGES TO THIS INFORMATION, CONSISTENT WITH FDA REGUALTIONS.)


 
Primary Conctact:    
 
First Name: *  
Last Name: *
Telephone: *    
Fax: *    
Email: *    
After Hours Phone :  
 
 
Backup Contact 1st: Back Up Contact 2nd:
 
First Name: First Name:
Last Name: Last Name:
Telephone: Telephone:
Fax: Fax:
Email: Email:
After Hours Phone: After Hours Phone:
 
 
Please Sign Below:
Full Name:*
Date:*