By using the services of Prior Notice Services LLC ("hereinafter referred to as Registrant's Authorized Representative" or "Prior Notice Services LLC"), you ("hereinafter referred to as Registrant") agree to the following terms and conditions.
Registrant authorizes Prior Notice Services LLC, a company registered in the State of Washington, to act as its authorized representative for the purpose of preparing and submitting Prior Notice filings 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. regulations.
Registrant agrees to provide accurate, truthful, complete, and current information and documents necessary for Prior Notice filings.
Registrant further agrees to promptly notify Prior Notice Services LLC of any updates or changes to the provided information.
Prior Notice Services LLC is entitled to rely on the information provided by the Registrant as true and accurate.
Registrant authorizes the employees and authorized agents of Prior Notice Services LLC to prepare and submit Prior Notice filings and related information to the U.S. Food and Drug Administration or any other legally authorized agency.
Prior Notice Services LLC will forward FDA communications related to such filings to the Registrant at the contact information provided.
Registrant authorizes Prior Notice Services LLC to use its mailing address for FDA correspondence if necessary and to disclose registration information (including Prior Notice confirmation numbers) as appropriate or beneficial for fulfilling its service obligations.
The services of Prior Notice Services LLC are limited to those necessary to prepare and submit Prior Notice filings to the FDA.
Fees shall be paid in accordance with Prior Notice Services LLC's Standard Price Schedule, subject to any updates published by the company.
Prior Notice Services LLC may perform additional services upon the Registrant's request, which will incur additional fees. Registrant authorizes Prior Notice Services LLC to charge Registrant's designated payment method for applicable fees.
Prior Notice Services LLC is not a law firm and does not provide legal advice. Our services are strictly limited to regulatory filing assistance.
Registrant agrees to indemnify, defend, and hold harmless Prior Notice Services LLC, its owners, officers, employees, and agents from and against any and all claims, liabilities, damages, losses, or expenses (including attorney's fees) arising out of:
Registrant waives any and all claims against Prior Notice Services LLC except for claims arising from gross negligence or willful misconduct, and such claims shall be limited to the amount of fees paid by the Registrant for the specific service giving rise to the claim.
Neither party shall be held liable for failure to perform obligations under this Agreement when such failure results from acts beyond its reasonable control.
This includes, but is not limited to, acts of God, war, terrorism, civil disturbances, natural disasters, or government restrictions.
This Agreement shall be governed by and construed in accordance with the laws of the State of Washington, without regard to its conflict-of-law principles.
Any dispute arising from or relating to this Agreement shall be brought exclusively in the courts of King County, Washington, or in the U.S. District Court for the Western District of Washington.
Both parties consent to the personal and subject matter jurisdiction of such courts.
This document constitutes the entire agreement between the Registrant and Prior Notice Services LLC and supersedes all prior communications or understandings, whether written or oral.
This Agreement may be terminated at any time by either party with written notice delivered by U.S. certified mail or verified electronic communication. Upon termination, any pending filings will be completed or cancelled as agreed by the parties.
If any provision of this Agreement is found invalid or unenforceable under applicable law, the remaining provisions shall remain in full force and effect.
This ensures that the enforceability of any single provision does not affect the validity of the entire Agreement.
Prior Notice Services LLC (Registered in the State of Washington):