Agreement – Medical Devices
AGREEMENT by and between Registrar Corp., (“Agent”) and Registrant.
The parties agree that Agent shall verify and issue a verification certificate that Registrant has registered with the U.S. Food and Drug Administration pursuant 21 C.F.R. Part 807 (the “FDA Regulations”) subject to the following terms and conditions:
- Registrant will provide Agent with all information and materials necessary or reasonably requested by Agent to fulfill Agent’s responsibilities hereunder and which may be required by the FDA Regulations. Registrant warrants that the information and materials provided by Registrant will be accurate, truthful, genuine and current. Registrant authorizes the employees of the Agent to access and verify the Registrant’s registration(s), and updates to such registration(s) to the U.S. Food and Drug Administration (“U.S. FDA”).
- The services performed by Agent under this agreement are limited to verifying that the records of the U.S. FDA reflect Registrant’s registration information and issuing a certificate verifying the same. Registrant shall maintain its own historical file required by 21 CFR § 807.31, and shall not require any such file to be maintained by Agent. Agent’s fee shall be paid in accordance with the FDA Registrar’s Standard Price Schedule. Agent may perform additional services in its discretion at Registrant’s request for additional fees. Agent does not and will not practice law or render legal advice.
- Registrant agrees to reimburse, indemnify and hold harmless Agent 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 Registrant, or any breach of law by Registrant. Registrant waives any and all claims against Agent 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. As used in this agreement, “Agent” shall include Registrar Corp., its successors, assigns, affiliates, parents, subsidiaries, officers, directors, shareholders, agents and employees.
- 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 U.S. Food and Drug Administration. Time shall not be of the essence for services to be rendered by Registrar Corp.
- 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 Northern, 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 Northern, Southern or Eastern Districts of New York.
- This document contains the entire agreement between the parties, and may not be modified except in writing signed by Agent. This Agreement may be terminated by either party at any time upon giving written notice to the other party by U.S. certified mail.
- Registrar Corp. is a private registration agent not affiliated with the U.S. Food and Drug Administration.