U.S. AGENT AGREEMENT
Bioterrorism Act –Food Safety Modernization Act
THIS AGREEMENT, dated as of the
between (4)
(1)
day of (2)
,
(3)
, located at (5)
,
,
including its heirs, successors and assigns, a foreign corporation registered under the law of
(6)
,
("PRINCIPAL"), and Deringer Logistics Consulting Group, A. N. Deringer Inc., its heirs, successors and
assigns, a corporation existing under and by virtue of the laws of The State of Vermont, having a principal place
of business located at 173 West Service Road, Champlain, NY. 12919. ("AGENT");
WHEREAS, PRINCIPAL is the owner, operator and/or agent-in-charge of a non-U.S. company 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 Administration
("FDA"), pursuant to 21 C.F.R. Part 1, Subpart H ("Regulations"); and as required under the Food Safety
Modernization Act – Section 415(a) 21 U.S.C. 350d as amended.
WHEREAS, pursuant to the Regulations a non-U.S. facility is required to have a U.S. AGENT; and
WHEREAS, AGENT is qualified 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 Regulations.
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
capacity as U.S. agent, by contacting PRINCIPAL at either the telephone number, facsimile number, email address, or emergency phone number, set forth on Appendix "A", attached.
4.
AGENT shall not be required to certify or transmit registrations on behalf of the PRINCIPAL.
5.
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).
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6.
(a) Except as specifically set forth herein, AGENT makes no express or implied warranties in connection
with its services:
(b) in no event shall AGENT be liable or responsible for consequential, indirect, incidental, statutory or
punitive damages, even if it has been put on notice of the possibility of such damages, or for the acts of
third parties.
7.
AGENT shall only keep such records that it is required to maintain by Statute(s) and/or Regulation(s),
but not act as a “recordkeeper” or “recordkeeping agent” for PRINCIPAL.
8.
PRINCIPAL shall use reasonable care to ensure the correctness of all such information and shall
indemnify and hold the AGENT harmless from any and all claims asserted and/or liability or losses
suffered by reason of the PRINCIPAL’S failure to disclose information or any incorrect, incomplete or
false statement by the PRINCIPAL or its agent, representative or contractor upon which the AGENT
reasonably relied.
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). Principal agrees to reimburse
Agent for any and all charges that may be levied on the Agent on behalf of the Principal by the U.S.
Food and Drug Administration. The Agent assumes no liability to validate charges made by FDA.
10.
All charges must be paid by PRINCIPAL in advance unless the AGENT agrees in writing to extend
credit to PRINCIPAL; the granting of credit to a PRINCIPAL in connection with a particular transaction
shall not be considered a waiver of this provision by the AGENT.
11.
In any dispute involving monies owed to AGENT, the AGENT shall be entitled to all costs of collection,
including reasonable attorney’s fees and interest at 15% per annum or the highest rate allowed by law,
whichever is less unless a lower amount is agreed to by AGENT.
12.
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.
13.
These terms and conditions of service and the relationship of the parties shall be construed according to
the laws of the State of Vermont without giving consideration to principals of conflict of law.
PRINCIPAL and AGENT
(a) Irrevocably consent to the jurisdiction of the United States District Court and the State
courts of Vermont;
(b) Agree that any action relating to the services performed by AGENT, shall only be brought in
said courts;
(c) Consent to the exercise of in personam jusridiction by said courts over it and
(d) Further agree that any action to enforce a judgment may be instituted in any jurisdiction.
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14.
These terms and conditions of service may only be modified, altered or amended in writing signed by
both PRINCIPAL and AGENT; any attempt to unilaterally modify, alter or amend same shall be null and
void.
15.
In the event any Paragraph(s) and/or portion(s) hereof is found to be invalid and/or unenforceable, then
in such event the remainder hereof shall remain in full force and effect. AGENT’S decision to waive any
provision herein, either by conduct or otherwise, shall not be deemed to be a further or continuing
waiver of such provision or to otherwise waive or invalidate any other provision herein.
IN WITNESS WHEREOF, the undersigned hereto executed this agreement on the day and year first written
above.
AGENT
Deringer Logistics Consulting Group
A. N. Deringer, Inc.
PRINCIPAL
(10)
(11)
Signature: (7)
(12)
Typed Name: (8)
Signature:
Title: (9 )
Typed Name:(14)
Title:
(13)
(15)
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Appendix A
(*) FDA Regulations require that the PRINICIPAL 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)(16)
In accordance with paragraph 3 of the attached AGENCY AGREEMENT, following are the phone and
facsimile numbers, and e-mail address, at which the AGENT may contact the PRINCIPAL.
(PRINICIPAL WILL IMMEDIATELY NOTIFY AGENT OF ANY CHANGES TO THIS INFORMATION,
CONSISTENT WITH FDA REGULATIONS.)
Primary Contact
Name: (17A)
Telephone:
E-mail:
(17B)
Facsimile:
(17C)
After hours telephone: (17E)
(17D)
1st Backup Contact Name: (18A)
Telephone: (18B)
Facsimile: (18C)
E-mail: (18D)
After hours telephone: (18E)
2nd Backup Contact Name: (19A)
Telephone: (19B)
Facsimile: (19C)
E-mail: (19D)
After hours telephone: (19E)
Please sign and date below.
Signature:
Date:
(20)
(21)
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Annex I
U.S. AGENT/FDA Support fee schedule:
Service
U.S. Agent Service
Fee
Canadian domiciled facility $775.00 (US) per year
Non-Canadian facility $975.00 (US) per year
FDA Support Services
$125.00 (US) per hour $75 minimum
*U.S. Agent service includes:







Communication link between your foreign facility and FDA
24/7 Staffing for emergency contact
Maintain a U.S. place of business
Registration assistance
Acknowledgement of amendments or changes
Records Retention (limited to those records provided by principal to agent)
Payment of charges to FDA as levied against Agent on behalf of Principal
(See Agent agreement for complete details)
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Form Instructions Bioterrorism Act – U.S. Agent Agreement
Please enter the following information in the blocks indicated on above Agreement:
1) List the day of the month the agreement is being completed on.
2) List the month the agreement is being completed in.
3) List the year the agreement is being completed in.
4) List your company’s full legal company name.
5) List the official physical address of your company’s home office.
6) List the country your company is located in.
(7-9)To be completed by A.N. Deringer
10) List your company’s full legal name.
11) List your company’s street address here.
12) List your company’s city, state/province, and postal code here.
13) Signature of individual given the authority to sign this agreement. If a corporation, the
individual must be a corporate officer.
14) Typed name of individual signing the agreement.
15) Title of person signing the agreement.
16) List your company’s full legal name.
17) In the event that Deringer must contact you for FDA Bioterrorism Issues, please indicate
your Primary Contact information in blocks A through E.
18) In the event we are unable to reach your Primary Contact, please indicate your First
Backup Contact information in blocks A through E.
19) In the event we are unable to reach either your Primary Contact or your First Backup
Contact, please indicate your Second Backup Contact information in blocks
A through E.
20) Signature of the individual given the authority to sign this agreement.
21) List the date the agreement was signed.
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