By accessing or using the services of Prior Notice Services LLC ("Registrant's Authorized Representative" or "Prior Notice Services LLC"), you ("Registrant") acknowledge that you have read, understood, and agree to be bound by these Terms and Conditions ("Agreement").
Acceptance of this Agreement may occur electronically, including through website interaction, checkbox selection, or payment submission.
Registrant authorizes Prior Notice Services LLC to act as its authorized representative for the purpose of preparing and submitting U.S. regulatory filings, including but not limited to Prior Notice filings and Food Facility Registrations, to the U.S. Food and Drug Administration (U.S. FDA).
This authorization is made pursuant to the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 ("Bioterrorism Act") and related U.S. federal regulations.
Registrant agrees to provide accurate, truthful, complete, and current information and documentation necessary to prepare and submit regulatory filings.
Registrant further agrees to promptly notify Prior Notice Services LLC of any updates or changes to previously submitted information.
Prior Notice Services LLC is entitled to reasonably rely on all information provided by the Registrant and shall not be responsible for errors or delays resulting from inaccurate, incomplete, or outdated information supplied by the Registrant.
Registrant authorizes the employees and authorized agents of Prior Notice Services LLC to prepare and submit regulatory filings and related information to the U.S. Food and Drug Administration or any other legally authorized U.S. agency.
Prior Notice Services LLC will forward FDA communications related to such filings to the Registrant using the contact information provided by the Registrant.
Registrant authorizes Prior Notice Services LLC to use its mailing address for FDA correspondence if necessary and to disclose registration or confirmation information (including Prior Notice confirmation numbers) as appropriate or beneficial to fulfill service obligations.
The services provided by Prior Notice Services LLC are limited to administrative and regulatory filing assistance required by the FDA.
Fees shall be paid in accordance with Prior Notice Services LLC's Standard Price Schedule, as published or updated from time to time. Fees are calculated based on information provided by the Registrant.
Additional services requested by the Registrant may incur additional fees, which the Registrant authorizes Prior Notice Services LLC to charge to the designated payment method.
Prior Notice Services LLC is not a law firm and does not provide legal advice. No attorney-client relationship is created by use of the services.
Registrant agrees to indemnify, defend, and hold harmless Prior Notice Services LLC and its owners, officers, employees, and agents from and against any and all claims, liabilities, damages, losses, costs, or expenses (including reasonable attorney's fees) arising out of or related to:
Registrant waives all claims against Prior Notice Services LLC except for claims arising from gross negligence or willful misconduct. Any such claims shall be limited to the fees paid for the specific service giving rise to the claim, to the maximum extent permitted by law.
Neither party shall be liable for failure or delay in performance caused by events beyond reasonable control, including but not limited to acts of God, war, terrorism, civil disturbances, pandemics, natural disasters, or government restrictions.
This Agreement shall be governed by, construed, and enforced in accordance with the laws of the State of New York, United States, without regard to its conflict-of-laws principles.
Any action, suit, or proceeding arising out of or relating to this Agreement, the services provided hereunder, or the transactions contemplated hereby shall be brought exclusively in the state courts located within the State of New York or the United States District Courts for the Southern, Eastern, or Northern Districts of New York.
Each party irrevocably consents to the personal and subject matter jurisdiction of such courts and waives any objection based on improper venue, forum non conveniens, or lack of jurisdiction.
Registrant acknowledges and agrees that this Agreement is entered into electronically, and that acceptance by electronic means constitutes valid and binding assent.
This Agreement constitutes the entire agreement between the parties and supersedes all prior or contemporaneous communications, representations, or agreements.
Either party may terminate this Agreement at any time by providing written notice through verified electronic communication or other commercially reasonable means. Upon termination, any pending filings shall be completed or cancelled as mutually agreed.
If any provision of this Agreement is found invalid or unenforceable, the remaining provisions shall remain in full force and effect.
Prior Notice Services LLC