GACC Registration

AGREEMENT by and between Registrar Corp and Your Company ("Exporter")

The parties agree that Registrar shall advise and assist Client concerning Client’s request for inclusion by the U.S. Food and Drug Administration (“FDA”) on the GACC Export List for China (“Export List”), subject to the following terms and conditions:

1. Client will provide Registrar with all information and materials necessary or reasonably requested by Registrar to fulfill Registrar’s responsibilities hereunder. Client warrants and certifies that the information and materials provided by Client will be accurate, truthful, complete, genuine, and current. Registrar shall provide advice and assistance in connection with the requirement above, and its duties shall be deemed satisfied upon completion of rendering such advice and assistance as would allow Client to complete the request to FDA properly. Registrar’s services do not and shall note include scientific, technical, or legal advice.
2. In consideration for such services, Client agrees that it will pay Registrar in accordance with Registrar’s standard fee schedule and any modifications or revisions thereto.
3. Client hereby expressly authorizes Registrar and its individual employees to submit applications on behalf of Client (including, but not limited to, accessing and using Client’s ELM account to do so), as Client’s “designee of the establishment” or other authorized representative, for inclusion on the Export List maintained by FDA through the FDA’s Export Listing Module (“ELM”) or similar FDA application program. Client certifies, represents and warrants, and authorizes Registrar and its individual employees to certify on such application that (a) the information listed on the application is true, complete, and accurate, (b) that the establishment (as that term is defined or understood by the application) and the products listed on the application are, to the best of Client’s knowledge, in compliance with all applicable requirements of the Federal Food, Drug, and Cosmetic Act ("the FD&C Act"), and all applicable regulations and standards, (c) the establishment (as that term is defined or understood by the application) listed on the application is currently registered with the FDA, if required by the FD&C Act, (d) the products listed on the application for export are legally marketed within the United States or meet the requirements of Section 801(e)(1) of the FD&C Act, (e) the products listed on the application are not the subject of a pending judicial enforcement action (e.g., an injunction or seizure) or a pending administrative action (e.g., warning letter), (f) the products listed on the application are being exported from the United States, (g) the Client understands that the information submitted is intended to assist FDA in establishing and maintaining a list of exporters, and (h) that the FDA considers the information shared on the application and the Export List, which is provided voluntarily with the understanding that it will be communicated to the competent authority and posted on the Internet, to be information that is not protected from disclosure under 5 U.S.C. 552(b)(4).
4. Client agrees to reimburse, indemnify and hold harmless Registrar from and against any and all expenses, costs and claims, including claims by third parties and nonparties, including but not limited to any governmental agencies, and related costs and attorneys' fees, whether such claims are alleged in tort, contract or under other law, arising out or in connection with this Agreement, the transactions contemplated hereby, any claim connected to the business or operations of Client, any breach of any representation or warranty herein, or any breach of law or government regulation by Client. Client waives any and all claims against Registrar arising out of or in connection with this Agreement except for willful misconduct or gross negligence and for those waives its claims to the extent the law permits. Registrar makes no representation except those set forth herein and does not warrant or guarantee any specific result, including but not limited to, the successful listing of Client or any of Client’s products on an Export List, and, even if successful, the timeliness thereof. As used in this Agreement, "Registrar" shall include Registrar Corp, its successors, assigns, affiliates, parents, subsidiaries, officers, directors, shareholders, agents and employees.
5. Neither party to this contract shall be held responsible for breach of contract caused by an act of God, insurrection, civil war, war, military operation, terrorism or local emergency, or by any act or failure to act by the FDA. Time shall not be of the essence for services to be rendered by Registrar. As used herein, the connectives “and” and “or” shall be interpreted conjunctively or disjunctively as necessary to bring within the scope of this Agreement all representations, warranties and indemnifications that might otherwise be excluded. This document contains the entire agreement between the parties and may not be modified except in writing signed by Registrar.
6. This Agreement shall be construed, and the relations between the parties determined, in accordance with the laws of the State of New York, without giving effect to its choice of law provisions. Any action or proceeding arising out of or in connection with this Agreement or the transactions contemplated hereby shall be brought in the courts of New York or the U.S. District Courts for the Southern or Eastern Districts of New York. The parties hereto consent to exercise of in personam and subject matter jurisdiction by the courts of the State of New York, and the U.S. District Courts for the Southern or Eastern Districts of New York.
7. This Agreement may be terminated by Registrar immediately upon Client’s breach hereof or by either party without cause upon ten days written notice by email to the address stated above for each party. No portion of any fee paid to Registrar shall be refunded in the event of termination.
8. Registrar is a private registration agent not affiliated with the FDA.