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Before Dec. 12th vs. After Dec. 12th--- How to file with US Customs and FDA

Register your facilities through C-TECH

DUTIES OF AGENT

As defined in the SERVICE AGREEMENT

I. The role of the US. agent is to serve as a communications link between FDA and the Facility for purposes including both emergency situations and day-to-day registration issues. These routine issues may include FDA's need for information about the Facility and arranging both routine inspections and inspections or communications with the Facility due to a potential bioterrorism threat or other public health emergency.

II. Agent shall, at all times during the term of this Agreement, reside or maintain a place of business physically in the United States.

III. Agent shall assist Facility in properly filing FDA Food Facility Registration form (Form 3537).

IV. Agent shall maintain contact with FDA by phone, fax, E-mail or written communications regarding the Facility and/or its products. Agent shall accurately convey information from FDA to the Facility within 10 US business days (excluding Saturday, Sunday and US holidays) by phone, E-mail, mail or fax as Agent deems appropriate.

V. Agent shall update the Registration within 10 days of receiving updated information from the Facility or as otherwise agreed. There is no extra charge for submitting updates. Facility shall provide update information in English or other languages agreed upon by the Agent and Facility.

VI. Duties of Agent under this Agreement are limited to those set forth in the Registration regulations and that Agent is not involved in the formulation, manufacture, promotion, marketing, inspection, quality control, or sale of Facility’s products.

LIABILITY

Agent will not act as an agent for any other business purposes that are not defined in this agreement. Agent shall not provide any legal, business or other advice outside the scope of the Registration regulations.

Agent is not responsible for violations of the “Bio-terrorism Act 2002” that are committed by the Facility. Facility shall defend, indemnify and hold Agent harmless from any and all claims arising in connection with the Facility or any of its products.

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