Terms and Conditions of FDARegistration.net
TERMS AND CONDITIONS OF FDAREGISTRATION.NET PDF Print E-mail
TERMS AND CONDITIONS OF FDAREGISTRATION.NET
U.S. AGENT & OFFICIAL CORRESPONDENT SERVICES AND REGISTRATION
For the United States Food and Drug Administration

BACKGROUND:
A. The Customer is of the opinion that the Consultant has the necessary qualifications, experience and abilities to provide services to the Customer.
B. The Consultant is agreeable to providing such services to the Customer on the terms and conditions set out in this Agreement.
IN CONSIDERATION OF the matters described above and of the mutual benefits and obligations set forth in this Agreement, the receipt and sufficiency of which consideration is hereby acknowledged, the parties to this Agreement agree as follows:

Services Provided
1. The Customer hereby agrees to engage the Consultant to provide the Customer with services (the "Services") consisting of United States Agent representation and Official Correspondent services for foreign/domestic facilities pursuant to U.S. Food and Drug Administration Regulations and the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, Section 305, including acting under full customer authority as the submitter of FDA registration forms to the FDA. FDARegistration.net shall complete and submit any required registration or cancellation forms to the FDA with all information as provided by the Customer, including Customer’s appointment of FDARegistration.net as its U.S. Agent (for non-U.S. companies) and FDARegistration.net’s consent to serve as the Customer’s Official Correspondent. It will be the responsibility of FDARegistration.net as the client’s United States Agent to perform the following tasks: Establish and maintain a confidential file for the client, keep an office address in the USA, assist the FDA as required for all client’s related issues, receive FDA documents as required, forward information on FDA contacts and documents to the client, assist the client with FDA Registration and Listing questions and problems, respond to questions concerning the foreign establishment's products that are imported or offered for import into the United States, and assist FDA in scheduling inspections of the foreign establishment. It will be the responsibility of FDARegistration.net as the client’s Official Correspondent to perform the following tasks: Establish and maintain a confidential file for the client, be a point of contact for all FDA correspondence, assist the FDA as required for all client’s related issues, receive FDA documents as required, forward information on FDA contacts and documents to the client, assist the client with FDA Registration and Listing questions and problems.. The Services will also include any other tasks which the parties may agree on. The Consultant hereby agrees to provide such Services to the Customer.

Term of Agreement
2. The term of this Agreement will begin on the date of this Agreement and will remain in full force and effect for 1 years from the date of the Agreement, subject to earlier termination as provided in this Agreement, with the said term being capable of extension by mutual written agreement of the parties.
3. In the event that the Consultant wishes to terminate this Agreement at a date before the end of this Agreement, they will be required to provide a notice period of 30 days. If the Customer wishes to end the contract at a date earlier than the end of this Agreement, they will provide a notice period of 30 days.
4. Except as otherwise provided in this Agreement, the obligations of the Consultant will terminate upon the earlier of the Consultant ceasing to be engaged by the Customer or the termination of this Agreement by the Customer or the Consultant.

Performance
5. The parties agree to do everything necessary to ensure that the terms of this Agreement take effect.

Compensation
6. For the services rendered by the Consultant as required by this Agreement, the Customer will pay to the Consultant compensation amounting to $998 (For U.S. Agent and Official Correspondent services for non-U.S based companies) OR $599 (For Official Correspondent services for U.S. based companies).  All other services (facility/establishment registration and/or product/device listing)rendered by the Consultant as required by this agreement shall receive compensation as indicated by the agreed upon prices during time of purchase.
7. This compensation will be payable upon completion of the agreed to services.
8. The Customer is entitled to deduct from the Consultant's compensation any applicable deductions and remittances as required by law.

Additional Compensation
9. In addition to the above compensation, the Consultant will be entitled to the following compensation for performing the Services: Any additional services that are provided to the Customer by FDARegistration.net not including United States Agent representation and Offical Correspondent services require additional fees/charges based on the type of service provided.

Refund Policy
10. All sales are final.  Services purchased from FDARegistration.net including United States Agent representation, Official Correspondent services, and facility registration(s)/product listing(s)/cancellations are non-refundable.

Provision of Extras
11. The Customer agrees to provide, for the use of the Consultant in providing the Services, the following extras: It will be the responsibility of the Company to provide the following information to FDARegistration.net so that the above referenced tasks can be performed in accordance with the regulatory requirements: Provide an update of changes to the establishment registration (i.e. address, change in ownership, etc.), notify of any new products (devices, pharmaceuticals, food products) for updated listings or changes to already listed products (i.e. dropping them from the product line.), changes in telephone, fax or email address so that the lines of communication can be kept open..

Confidentiality
12. Confidentiality will end with this Agreement

Non-Competition
13. Other than with the express written consent of the Customer, which will not be unreasonably withheld, the Consultant will not, during the continuance of this Agreement or within 1 year after the termination of this Agreement, be directly or indirectly involved with a business which is in direct competition with the particular business line of the Customer, divert or attempt to divert from the Customer any business the Customer has enjoyed, solicited, or attempted to solicit, from other individuals or corporations, prior to termination of this Agreement.

Non-Solicitation
14. Any attempt on the part of the Consultant to induce to leave the Customer's employ, or any effort by the Consultant to interfere with the Customer's relationship with its employees or other consultants would be harmful and damaging to the Customer.
15. The Consultant agrees that during the term of this Agreement, the Consultant will not in any way directly or indirectly:
1. induce or attempt to induce any employee or other consultant of the Customer to quit employment or retainer with the Customer;
2. otherwise interfere with or disrupt the Customer's relationship with its employees or other consultants;
3. discuss employment opportunities or provide information about competitive employment to any of the Customer's employees or other consultants; or
4. solicit, entice, or hire away any employee or other consultant of the Customer.

Ownership of Materials
16. All materials developed, produced, or in the process of being so under this Agreement, will be the property of the Customer. The use of the mentioned materials by the Customer will not be restricted in any manner.
17. The Consultant may retain use of the said materials and will not be responsible for damages resulting from their use for work other than services contracted for in this Agreement.
Return of Property
18. Upon the expiry or termination of this Agreement, the Consultant will return to the Customer any property, documentation, records, or confidential information which is the property of the Customer.

Assignment
19. The Consultant will not voluntarily or by operation of law assign or otherwise transfer its obligations under this Agreement without the prior written consent of the Customer.
Capacity/Independent Contractor
20. It is expressly agreed that the Consultant is acting as an independent contractor and not as an employee in providing the Services under this Agreement. The Consultant and the Customer acknowledge that this Agreement does not create a partnership or joint venture between them, and is exclusively a contract for service.

Modification of Agreement
21. Any amendment or modification of this Agreement or additional obligation assumed by either party in connection with this Agreement will only be binding if evidenced in writing signed by each party or an authorized representative of each party.
Notice
22. All notices, requests, demands or other communications required or permitted by the terms of this Agreement will be given in writing and delivered to the parties of this Agreement.
Costs and Legal Expenses
23. In the event that legal action is brought to enforce or interpret any term of this Agreement, the prevailing party will be entitled to recover, in addition to any other damages or award, all reasonable legal costs and fees associated with the action.

Time of the Essence
24. Time is of the essence in this Agreement. No extension or variation of this Agreement will operate as a waiver of this provision.

Entire Agreement
25. It is agreed that there is no representation, warranty, collateral agreement or condition affecting this Agreement except as expressly provided in this Agreement.

Limitation of Liability
26. It is understood and agreed that the Consultant will have no liability to the Customer or any other party for any loss or damage (whether direct, indirect, or consequential) which may arise from the provision of the Services.

Indemnification
27. The Consultant will indemnify and hold the Customer harmless from any claims against the Customer by any other party, arising directly or indirectly out of the provision of the Services by the Consultant.

Enurement
28. This Agreement will enure to the benefit of and be binding on the parties and their respective heirs, executors, administrators, successors and permitted assigns.

Currency
29. Except as otherwise provided in this Agreement, all monetary amounts referred to in this Agreement are in United States dollars

Titles/Headings
30. Headings are inserted for the convenience of the parties only and are not to be considered when interpreting this Agreement.

Gender
31. Words in the singular mean and include the plural and vice versa. Words in the masculine mean and include the feminine and vice versa.

Governing Law
32. It is the intention of the parties to this Agreement that this Agreement and the performance under this Agreement, and all suits and special proceedings under this Agreement, be construed in accordance with and governed, to the exclusion of the law of any other forum, by the laws of the State of New York, without regard to the jurisdiction in which any action or special proceeding may be instituted.

Severability
33. In the event that any of the provisions of this Agreement are held to be invalid or unenforceable in whole or in part, all other provisions will nevertheless continue to be valid and enforceable with the invalid or unenforceable parts severed from the remainder of this Agreement.

Waiver
34. The waiver by either party of a breach, default, delay or omission of any of the provisions of this Agreement by the other party will not be construed as a waiver of any subsequent breach of the same or other provisions.