FACILITY REGISTRATION AND FDA AGENT AGREEMENT by and between TABS Inc., (“Agent”) and Your Company (“Client”).
The parties agree that Agent shall serve as Client’s designated U.S. Agent pursuant to section 415(a) of the U.S. Food, Drug and Cosmetic Act, 21 U.S.C. sec. 350(d)(a) (the “Act”), subject to the following terms and conditions:
1. Client authorizes Agent to register its food facility, as identified in the electronic submission to TABSInc.com or as confirmed by TABS in writing, with the U.S. Food and Drug Administration (“FDA”) pursuant to section 415(a) of the Act and to update or renew any such registration information provided in connection therewith, during the term hereof, pursuant to 21 C.F.R. Sec. 1.225 et seq.
2. Client acknowledges and understands that pursuant to 21 C.F.R. 1.231(4), the FDA will attempt to verify that the individual identified as having authorized the submission of the registration on behalf of the facility did in fact authorize the submission. This verification must be completed before the FDA will confirm a registration, provide a registration number or provide a confirmation of registration renewal.
3. Client consents to inspection by FDA and authorizes Agent to consent to inspection of the facility by FDA and to such other conditions as are required by FDA for facility registration. Client represents and warrants that it is the owner, operator, or agent in charge of the identified facility, and is responsible for compliance pursuant to 21 C.F.R sec. 1.225 et seq. Client will provide Agent with all information and materials necessary or reasonably requested by Agent to register the food facility and to fulfill Agent’s responsibility as U.S. Agent pursuant to the Act. In the event that Client provides e-mail or other written communication modifying or supplementing the Legal Company Name and Company Address identified above, such information may be relied upon by Agent and shall be incorporated herein by reference. Client warrants that the information and materials provided by Client will be accurate, truthful, genuine, and current. Agent will forward all communications from the FDA to Client at the address, telephone number, or email address stated above. Agent may (but is not required to) cancel Client’s food facility registration in the event that Client fails to respond to communications from Agent or fails to designate a replacement U.S. Agent within ten (10) days of notification by Agent to Client that Agent intends to resign as Client’s U.S. Agent under the Act.
4. The services performed by Agent under this agreement are limited to those required to be performed by Agent pursuant to the Act. Agent’s fee shall be paid in accordance with Agent’s standard fee schedule and any modifications or revisions thereto. Agent may perform additional services in its discretion at Client’s request for additional fees. Agent does not and will not practice law or render legal advice.
5. Client agrees to reimburse, indemnify and hold harmless Agent from and against any and all expenses, costs, and claims, including claims by third parties, including but not limited to any governmental agencies, and costs related thereto, including but not limited to attorneys’ fees, any re-inspection fees owed to FDA, whether such claims are alleged in tort, contract or under other law, arising out of or in connection with this agreement, the transactions contemplated hereby, any claim connected to the business or operations of Client, or any breach of law by Client.
6. FOREIGN FACILITY 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. UNDER NO CIRCUMSTANCES SHALL AGENT BE HELD LIABLE FOR LOSS OF PROFITS, OR ANY SPECIAL CONSEQUENTIAL OR INCIDENTAL DAMAGES, HOWEVER, CAUSED, KNOWN OR UNKNOWN, ANTICIPATED OR UNANTICIPATED, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGE. THE PARTIES ACKNOWLEDGE THAT THESE LIMITATIONS ON POTENTIAL DAMAGES WERE AN ESSENTIAL ELEMENT IN SETTING CONSIDERATION UNDER THIS AGREEMENT. As used in this agreement, “Agent” shall include TABS Inc., its successors, assigns, affiliates, parents, subsidiaries, officers, directors, shareholders, agents, and employees. In the event that the FDA notifies Client or Agent or both that FDA intends to conduct a reinspection of Client’s facility, Client shall pay to Agent in advance of such inspection a deposit, or secure a bond, in such amount as is reasonably requested by Agent to pay for anticipated reinspection fees to be charged by FDA or otherwise to be incurred or obligated by Agent in connection with or arising out of such reinspection, and Client shall pay immediately any deficiency in such deposit or bond resulting from fees charged by FDA or other expenses incurred by Agent in connection therewith.
7. Neither party to this contract shall be held responsible for breach of contract caused, in whole or in part, by an act of God, war (whether declared or not), armed conflict or the serious threat of the same (including but not limited to hostile attack, blockade, military embargo), hostilities, invasion, act of a foreign enemy, extensive military mobilization; civil war, riot, rebellion, revolution, military or usurped power, insurrection, civil commotion or disorder, mob violence, act of civil disobedience; act of terrorism, sabotage or piracy; plague, epidemic, pandemic, outbreaks of infectious disease or any other public health crisis, including quarantine or other employee restrictions; act of authority whether lawful or unlawful, compliance with any law or governmental order, rule, regulation or direction, curfew restriction, expropriation, compulsory acquisition, seizure of works, requisition, nationalization; act of God or natural disaster such as but not limited to violent storm, cyclone, typhoon, hurricane, tornado, blizzard, earthquake, volcanic activity, landslide, tidal wave, tsunami, flood, damage or destruction by lightning, drought; explosion, fire, destruction of machines, equipment, factories and of any kind of installation, prolonged break-down of transport, telecommunication or electric current; general labor disturbance such as but not limited to boycott, strike and lock-out, go-slow, occupation of factories and premises; shortage or inability to obtain critical material or supplies to the extent not subject to the reasonable control of the subject Party (“Force Majeure Event”)
8. Time shall not be of the essence for services to be rendered by Agent. This document, together with the documents incorporated herein by reference, contains the entire agreement between the parties, and may not be modified except in writing signed by the party to be charged. The use of the plural herein includes the singular and vice versa.
9. This agreement shall be construed, and the legal 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 District 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 District of New York.
10. Agent may terminate this Agreement at any time upon giving written notice to Client by U.S. Mail to the address stated above or provided by Client for its food facility registration, or by fax to the fax number provided by Client for its food facility registration, or by e-mail to the e-mail address provided by Client for its food facility registration. Client may cancel this Agreement at any time by FedEx, DHL, or UPS overnight delivery service, or by fax to the address and fax number stated above, with such information as will confirm that Client’s food facility registration has been maintained or canceled consistent with the requirements of the Act. In the event of termination by either party, no part of the fees paid to Agent hereunder shall be refunded, and the last sentence of paragraph 1 shall survive termination and remain in effect.
11. This agreement shall expire on 31 December 2023, unless terminated earlier, except for the last sentence of paragraph 1, which shall survive termination. Commencing January 1, 2024, this agreement will renew automatically for successive terms of one year unless terminated pursuant to the terms hereof.
12. Client acknowledges that TABS Inc. is not affiliated with the U.S. Food and Drug Administration but is a private company providing services to Client.