INSPECTION STATEMENT (Required) FDA will be permitted to inspect the facility at the time and in the manner permitted by the Federal Food, Drug, and Cosmetic Act. The owner, operator, or agent in charge of the facility, or an individual authorized by the owner, operator, or agent in charge of the facility, must submit this form.By submitting this form to FDA, or by authorizing an individual to submit this form to FDA, the owner, operator, or agent in charge of the facility certifies that the above information is true and accurate.
An individual (other than the owner, operator, or agent in charge of the facility) who submits the form to the FDA also certifies that the above information submitted is true and accurate and that he/she is authorized to submit the registration on the facility’s behalf.
An individual authorized by the owner, operator, or agent in charge must below identify by name the individual who authorized submission of the registration. Under 18 U.S.C. 1001, anyone who makes a materially false, fictitious, or fraudulent statement to the U.S. Government is subject to criminal penalties. US AGENT AGREEMENT (Required) I understood and agreed to
AGREEMENT FOR SERVICES AS UNITED STATES AGENT
Pursuant to 21 U.S.C. § 350d(a)(1)(B); 21 C.F.R. § 1.232(d)
THIS AGREEMENT is entered into by and between Garg Law PLLC, an Arizona Corporation, with principal offices at 7150 East Camelback Road, Suite 444, Scottsdale, AZ 85251, (“Agent”) and (“Company”), collectively which may be referred to as “Parties” or each “Party”.
WHEREAS AGENT offers regulatory services to companies who register their food facilities pursuant to 21 U.S.C. § 350d(a)(1)(B); 21 C.F.R. § 1.232(d) (“Regulation”);
NOW THEREFORE, for the mutual promises, covenants, and other good and valuable consideration further described hereinafter, the parties agree as follows:
A. This Agreement is effective on 03/26/2023 (the Effective Date), and is valid until 12/31/2023 for the following of
B. This Agreement shall automatically renew, unless Company notifies Agent in writing at least sixty (60) days prior to the end of
the term of the current Agreement. Any renewal hereof shall be at the then current Agent Fee.
C. In the event Agent does not intend to renew this Agreement, Agent must notify Company of this intent within 30 days of the
termination of current Agreement.
2. AGENT FEE:
Company shall pay Agent a fee to act as its U.S. Agent for a period of time as provided below in accordance with Section 1, and to
renew its registration. Fees paid under this Agreement shall be deemed a fully earned retainer, in consideration for committing
availability, and not subject to refund except as provided in Section 10 of this Agreement.
Payment of the Fee, in U.S. Currency, shall be made upon signing of this Agreement by electronic transfer to Agent’s bank pursuant
to the transfer instructions provided by Agent at the execution of the Agreement or by Company check. Any delay in receipt of
funds will delay the Effective Date of this Agreement by the delay period.
4. DUTIES OF AGENT:
A. Agent shall:
i) Maintain a physical place of business including email and telephone connection within the United States of America
during the Term of this Agreement;
ii) Accept all calls and correspondence from FDA regarding the Company or its products and report to Company within a
timely manner of all FDA correspondence;
iii) At the request of Company, and for a separate registration fee, assist Company with medical device facility registration
B. Absent a separate Agreement, Agent shall NOT:
i) Provide any legal advice on any FDA matters or advise Company of FDA regulations pertaining to Company or its
ii) Provide assistance in any way regarding the preparation or filing of any documents with FDA.
C. Services Outside Scope of Agreement:
Any work beyond the scope of this Agreement will be completed in accordance with terms outlined in Company’s Client
Retention Agreement on file with Agent or by separate Agreement with Agent.
5. DUTIES OF COMPANY
Company shall, upon execution of this Agreement provide Agent with:
A. A list of contacts at Company, in descending order of priority, including their telephone, email and fax numbers. The list shall
include at least one (1) 24- hour contact by name, title and telephone number for emergency contact purposes. This list shall be
maintained current at all times and Company shall update it as appropriate within five (5) business days of any changes;
B. A response, within five (5) business days, to all inquiries from FDA forwarded by Agent to Company pursuant to the terms of this
C. Proof of medical device facility registration, including facility registration numbers, and any information submitted to FDA during
the facility registration process if Company has chosen to complete registration of its facility on its own.
Agent shall maintain confidentiality with regards to its actions pursuant to this Agreement and shall not disclose Confidential Information to any other than those individuals of Company identified in a list pursuant to Section 5A of this Agreement. “Confidential Information” entails any data or information that is competitive, proprietary or otherwise sensitive material, of value to the Company, and not generally known by the public including but not limited to business and marketing plans, internal testing and performance results and product planning information.
For purposes of this Agreement, Confidential Information shall not include any information:
A. that is publicly available at the time of disclosure;
B. that is or becomes generally known to the public through no fault of the recipient;
C. that is obtained without restriction from an independent source having a bona fide right to use and disclose such information, without restriction as to further use or disclosure;
D. that the disclosing party approves for unrestricted release by written authorization; or
E. that is required to be disclosed by law, except to the extent eligible for special treatment under an appropriate protective order.
Company acknowledges that the duties of Agent under this Agreement are limited to those contemplated by FDA in the regulations and that Agent is not in any way involved in the design, development, promotion, marketing, sale, manufacture or quality control of any of Company’s products which are imported, or offered for import, into the United States. Company shall defend, indemnify and hold Agent, his officers, agents, consultants, directors, employees and/or his associates harmless from all claims for any reason whatsoever from any third party against Company or any of its products.
8. REIMBURSEMENT FOR FEES ASSESSED BY FDA ON AGENT
Company agrees to provide an advanced deposit and/or reimburse Agent for any fees assessed on Agent by FDA as a result of this Agreement with Company including but not limited to fees incurred as a result of re-inspection by FDA of one or more of Company’s foreign facilities, as determined by Agent’s sole and absolute discretion.
9. INDEPENDENT AGENT
Agent is an independent entity and is not authorized or obligated to act on behalf of Company in any matter outside the scope of this Agreement.
This Agreement may be terminated without cause by either party upon thirty (30) days prior written notice of the intent to do so. If the Company terminates this Agreement under this section it will not be entitled to a refund of fees paid. If Agent terminates this Agreement, Agent will refund a prorated portion of Fees paid pursuant to Section 2 of this Agreement.
11. ENTIRE AGREEMENT AMENDMENT:
This Agreement constitutes the total agreement between Agent and Company and all prior discussions are incorporated hereinto. No change shall have any force or effect on this Agreement unless it is reduced to writing and signed by both Agent and Company.
12. GOVERNING LAW
This Agreement shall be governed by, and interpreted and construed in accordance with, the laws of the State of Arizona, U.S.A., which shall be the proper law of this Agreement notwithstanding any conflict-of-laws rules or principles therein contained under which any other law would be applicable.
This Agreement may be executed in counterparts, provided that each page of the Agreement is initialed by the executing Party, and each counterpart shall be deemed an original but together they shall constitute one and the same instrument.
A. Assignment. This Agreement shall be binding upon and inure to the benefit of the respective successors and assigns of each Party hereto, but shall not be assigned by either Party without first obtaining the written consent of the other, provided, that either Party may assign this Agreement to any one of its affiliates capable of performing such Party’s obligations hereunder upon written notice to the other Party provided that such affiliate assumes the Party’s obligations in writing hereunder and agrees to be bound by the terms and conditions hereof.
B. Binding Agreement; Modifications and Waivers. This Agreement shall not be binding upon either Party until it is signed by an authorized representative at its principal office, and no change in, addition to or waiver of the terms and provisions hereof shall be binding upon either Party unless approved, in writing by an authorized representative of the Party, furthermore, no modifications to this Agreement shall be effected by the execution, delivery, acknowledgement or acceptance of purchase order forms or invoice containing other or different terms and conditions.
C. Headings. The headings in this Agreement are for reference only and do not limit or affect the interpretation thereof.
D. Severability. The provisions of this Agreement shall be deemed severable, in whole or in part, and this Agreement shall be interpreted and enforced as if all completely invalid or unenforceable provisions are not contained in this Agreement, and partially valid and enforceable provisions shall be enforced to the extent that they are valid and enforceable. Furthermore, the Parties agree that if any provisions of this Agreement may be construed in two (2) ways, one of which would render the provision illegal, invalid or unenforceable under the applicable law, and the other of which renders it valid and enforceable, then such provision shall have the meaning which renders it valid and enforceable. It is the intent of the Parties that the provisions of this Agreement be enforced to the fullest extent, and should any court or other public agency determine that any provision herein is not enforceable as written in this Agreement, the provision shall be amended by the Parties so that it is enforceable to the fullest extent permissible under the laws and public policies of the jurisdiction in which enforcement is sought and affords the Parties the same basic rights and obligations and has the same economic effect.
E. Language. The English language version of this Agreement shall be controlling in all respects. No translation of this Agreement into any other language shall be of any force or effect in the interpretation or construction of this Agreement, as far as the Parties are concerned. The provisions of this Agreement shall be construed in accordance with their fair meaning and not strictly against either Party.