FDA Solutions Group, LLC Terms & Conditions of Service
1. DEFINITIONS
a) “FDA SOLUTIONS” shall refer to FDA SOLUTIONS GROUP, LLC, its subsidiaries, agents and/or representatives.
b) “CLIENT” shall include the individual or entity to whom FDA SOLUTIONS is rendering consulting services, as well as its principals, agents and/or representatives; all principals, agents and/or representatives are deemed to have obtained appropriate authorization from Client prior to entering into this Agreement; it shall be the responsibility of the Client to provide notice and copy(s) of these Terms and Conditions of Service to any principals, agents and/or representatives;
c) “Parties” shall refer to FDA SOLUTIONS and CLIENT collectively;
d) “Documentation” shall refer to all information received directly or indirectly from CLIENT, whether in paper or electronic form;
e) “Contact Person” shall refer to the individual or entity designated by CLIENT as a contact person in Documentation, and will be the primary contact for all communications from FDA SOLUTIONS to CLIENT; all communications with Contact Person will be sent via electronic mail (e-mail) unless otherwise provided below;
f) “Service Fees” shall refer to fees payable to FDA SOLUTIONS by CLIENT for the provision of registration, listing, advisory and/or consulting services.
2. AGREEMENT BETWEEN PARTIES
These terms and condition of service, payment of service fees to FDA SOLUTIONS, submission of Documentation, U.S. Agent Agreement (if applicable) and the policies and procedures published on www.fdasolutionsgroup.com, which may change from time to time, constitute the Agreement between the parties (“Agreement”). This Agreement shall be binding upon and inure to the benefit of the Parties hereto and their respective successors and permitted assigns.
3. SCOPE
FDA SOLUTIONS shall provide CLIENT with consulting services relating to the processing and submission of registrations, listings, filings, and/or notifications to government agencies; U.S. Agent; and/or label review and regulatory compliance advisory. Additionally, Facility Registrations exclusively involve consulting services relating to processing and submission of registrations and U.S. Agent representation. This service does not involve label review compliance or other services not otherwise agreed to. The Parties hereby agree that FDA SOLUTIONS will provide CLIENT only with those services for which CLIENT has remitted payment to FDA SOLUTIONS.
4. FDA SOLUTIONS AS AGENT AND CONTRACTOR
FDA SOLUTIONS acts as the agent of the CLIENT for the purpose of performing duties in connection with the transmission of information to the U.S. Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), the Alcohol and Tobacco Tax and Trade Bureau (TTB), or other dealings with U.S. Government Agencies; as to all other services, FDA SOLUTIONS acts merely as an independent contractor.
5. PAYMENT OF SERVICE; GOVERNMENT FEES; FEE RETAINERS
All service fees to FDA SOLUTIONS are immediately due and must be paid before any services can be rendered by FDA SOLUTIONS to CLIENT. Additionally, some registration and listing services require payment of fees to the government agency(ies). Payment of service fees to FDA SOLUTIONS shall be included with and is in addition to all government fees. The Parties agree that FDA SOLUTIONS will not perform any consulting services for or on behalf of CLIENT unless and until all service and government fees are paid in full. FDA SOLUTIONS reserves the right to require a cost deposit, letter of credit, or other form of guarantee from client for the payment of foreseeable government or third party fees, the amount of which shall be set forth in future communications between FDA SOLUTIONS and CLIENT.
6. RELIANCE ON INFORMATION FURNISHED
In preparing and submitting information to government agencies on behalf of CLIENT, FDA SOLUTIONS relies on the correctness of all documentation, whether in written or electronic format, and all information furnished by CLIENT; CLIENT shall be solely responsible for ensuring the continued accuracy of information for the duration of the contract term. Whenever there is a change to CLIENT’s information, CLIENT’s contact person shall submit written notifications of the change via electronic mail to info@fdasolutionsgroup.com; CLIENT shall exercise reasonable care to ensure the correctness of all such information and shall indemnify and hold FDA SOLUTIONS harmless from any and all claims asserted and/or liability or losses suffered as a result of CLIENT’s failure to disclose information or any incorrect, incomplete or false statement by CLIENT or its agent, representative or contractor upon which FDA SOLUTIONS reasonably relied.
7. TERMINATION
This Agreement will automatically terminate upon completion or upon expiration of the service term for which CLIENT has remitted payment to FDA SOLUTIONS. The Parties agree that FDA SOLUTIONS may terminate this Agreement at any time for non-payment, fraud, or failure to observe these terms and conditions. FDA SOLUTIONS will provide written notice of termination to Contact Person via electronic mail (e-mail), at least ten (10) days before the termination date, whenever practicable, or within fifteen (15) days of the termination date, in all other instances.
8. DISCLAIMERS; LIMITATION OF LIABILITY
(A) EXCEPT AS SPECIFICALLY SET FORTH HEREIN, FDA SOLUTIONS MAKES NO EXPRESS OR IMPLIED WARRANTIES IN CONNECTION WITH ITS SERVICES OR THOSE OF ANY THIRD PARTY.
(B) THE PARTIES AGREE THAT IF THE CLIENT SUFFERS ANY LOSS, DAMAGE, PENALTY, FINE, ASSESSMENT OR OTHER PECUNIARY INJURY (EACH AND/OR ALL OF THE FOREGOING REFERRED TO AS “LOSS”) CAUSED BY, ARISING FROM, OR RELATED TO FDA SOLUTIONS’S REGISTRATION AND LISTING SERVICES, FDA SOLUTIONS’S LIABILITY FOR SUCH LOSS SHALL BE LIMITED TO FIFTY-DOLLARS ($50.00) PER REGISTRATION OR LISTING; FDA SOLUTIONS’S LIABILITY FOR CLAIMS ARISING FROM SERVICES OTHER THAN REGISTRATION AND/OR LISTING SHALL BE LIMITED TO TEN PERCENT (10%) OF THE SERVICE FEES PAID TO FDA SOLUTIONS FOR THE SPECIFIC SERVICE THAT RESULTED IN THE LOSS.
(C) IN NO EVENT SHALL FDA SOLUTIONS BE LIABLE OR RESPONSIBLE FOR CONSEQUENTIAL, INDIRECT, INCIDENTAL, REMOTE, SPECULATIVE, STATUTORY OR PUNITIVE DAMAGES, EVEN IF IT HAS BEEN PUT ON NOTICE OF THE POSSIBILITY OF SUCH DAMAGES, OR FOR THE ACTS OF THIRD PARTIES. IN NO EVENT SHALL FDA SOLUTIONS BE LIABLE OR RESPONSIBLE FOR THE PAYMENT OF ANY FEES OWED TO ANY GOVERNMENT AGENCY BY CLIENT; ANY CLAIMS FROM A GOVERNMENT AGENCY RESULTING FROM UNPAID FEES; NOR FOR ANY CONSEQUENTIAL, INDIRECT, INCIDENTAL, REMOTE, SPECULATIVE, STATUTORY OR PUNITIVE DAMAGES THAT MAY RESULT FROM CLIENT’S FAILURE TO PAY ANY GOVERNMENT FEES.
(D) FDA SOLUTIONS SHALL NOT BE LIABLE FOR LOSS, DAMAGE, DELAY OR MONETARY LOSSES OF ANY TYPE CAUSED BY: ACTS OF GOD; PUBLIC AUTHORITIES ACTING WITH ACTUAL OR APPARENT AUTHORITY; WEATHER; MECHANICAL FAILURES; CIVIL COMMOTIONS; PUBLIC ENEMIES; HAZARDS INCIDENT TO A STATE OF WAR; ACTS OF TERRORISM; AND ACTS, DEFAULTS OR OMISSIONS OF THE CLIENT OR CONTACT PERSON; CLIENT’S CARELESSNESS OR NEGLIGENCE; AND FOR CLIENT’S FAILURE TO OBSERVE THESE TERMS AND CONDITIONS.
9. INDEMNIFICATION/HOLD HARMLESS
CLIENT agrees to indemnify, defend, and hold FDA SOLUTIONS harmless from any claims and/or liability, fines, penalties and/or attorneys' fees arising from any conduct of the CLIENT or its Contact Person, agents, assigns and representatives, including but not limited to the inaccuracy of information on Documentation provided to FDA SOLUTIONS which violates any Federal, State and/or other laws; failure to communicate with FDA SOLUTIONS and/or respond to notices and requests from FDA SOLUTIONS; misunderstandings and misinterpretations of information received from FDA SOLUTIONS or obtained on www.fdasolutionsgroup.com; as well as nonpayment of fees to government agencies, and further agrees to indemnify and hold FDA SOLUTIONS harmless against any and all liability, loss, damages, costs, claims, penalties, fines and/or expenses, including but not limited to reasonable attorney's fees, which FDA SOLUTIONS may hereafter incur, suffer or be required to pay by reason of such claims; in the event that any claim, suit or proceeding is brought against
FDA SOLUTIONS, it shall give notice in writing to the CLIENT by mail at its address on file with FDA SOLUTIONS.
10. CONFIDENTIALITY
With the exception of the communications with government agencies, or for purposes of collection, FDA SOLUTIONS shall not disclose information designated as confidential by CLIENT and that it will treat said information with the same care and confidentiality it treats its own confidential information. FDA SOLUTIONS is an independent advisory and consulting company, it is not a law firm. Communications between CLIENT and FDA SOLUTIONS are not subject to the attorney-client privilege, or any other privileges, protections or confidences that are unique to the attorney-client relationship.
11. GOVERNING LAW; VENUE AND CONSENT TO JURISDICTION
This Agreement shall be governed by and construed in accordance with the laws of the state of Florida (without giving effect to its choice of law or conflict of law provisions). The Parties hereto irrevocably and unconditionally submit to the jurisdiction of the state and federal courts located in Miami-Dade County and irrevocably agree that all actions or proceedings arising out of or relating to this agreement or the transactions contemplated herein shall be litigated exclusively in such. The parties further agree that an action to enforce judgment may be instituted in any jurisdiction.
12. ARBITRATION
Any controversy or claim arising out of or relating to these Terms and Conditions of Service and/or the relationship of the parties, shall be conclusively resolved through binding arbitration under the Commercial Arbitration Rules of the American Arbitration Association. Judgment on the award rendered by the arbitrator(s) may be entered in any court having jurisdiction thereof. Each party shall bear its own costs and attorney fees, unless the arbitration award specifically provides otherwise. The seat, or legal place, of arbitration shall be Miami, Florida, USA. The arbitration shall be in English.
13. ATTORNEY’S FEES
In the event of a judicial or administrative proceeding or action with respect to the interpretation or enforcement of this Agreement, the prevailing party shall be entitled to recover reasonable costs and expenses including, without limitation, reasonable attorneys’ fees and expenses, whether at the investigative, pretrial, trial or appellate level. The prevailing party shall be determined by the court based upon an assessment of which party’s major arguments or position prevailed.
14. SEVERABILITY
If any covenant or other provision of these Terms and Conditions of Service is deemed to be invalid, illegal or incapable of being enforced, by reason of any rule, law or public policy, all other covenants and provisions of this document shall nevertheless remain in full force and effect and no covenant or provision shall be deemed dependent on any other covenant or provision unless so expressed herein.
15. WAIVERS
The failure or delay of any party hereto in exercising any right granted it hereunder shall not constitute a waiver of any such right and any single or partial exercise of any particular right by such party shall not exhaust the same or constitute a waiver of any other right provided herein.
16. APPLICATION
This Agreement shall not be construed more strictly against one party than against the other merely by virtue of the fact that it may have been prepared primarily by counsel for one of the parties, it being recognized that all parties have had the opportunity to review this Agreement, seek legal counsel regarding its provisions and all parties understand the terms and conditions contained herein.
17. ENTIRE AGREEMENT
This Agreement constitutes the entire agreement between the Parties with respect to the matters set forth herein, and supersedes all prior understandings between the Parties with respect to matters relating to the services to be performed by FDA SOLUTIONS.