FDA Agent Pro Scope of Services and Terms and Conditions Service: US Agent Services
"Company" means the receiving party of services
FDA Agent Pro is a private consulting firm that offers U.S. agent services to foreign companies and is not affiliated with the U.S Food and Drug Administration (FDA). By accepting this agreement, the Company agrees to follow the terms:
FDA Agent Pro acts as a U.S. agent for the Company to facilitate communication between the FDA (U.S. Food and Drug Administration) and is only responsible for transmitting the information received from the FDA to the Company unless a specific service agreement exists for different services.
The U.S. agent agreement between the Company and FDA Agent Pro will remain effective for 12 months or 24 months from the date of payment, as per the option selected on the form. Unless extended, this is the period specified.
The fee paid for the US Agent services is non-refundable.
U.S. agent fees do not include any other consulting or regulatory work unless jointly agreed to by both parties.
The company warrants that the information provided in this form is Truthful and Accurate. It remains the Company's responsibility to update any change in the provided information.
The Company acknowledges that FDA Agent Pro is acting as a U.S. Agent between the Company and the Food and Drug Administration and has no involvement or specific knowledge of the Company’s products.
Company will not hold FDA Agent Pro liable for any negligence and/or damages whatsoever, including but not limited to any liability arising concerning the performance of the Company’s products.
Neither party to this contract shall be held responsible for a breach of contract caused by an act of God, insurrection, civil war, military or local emergency, or by any act or failure to act by the U.S. Food and Drug Administration.
In case of any breach of terms, FDA Agent Pro has the right to terminate the services with seven days' advance notice.
In case of non-payment for renewal of services, FDA Agent Pro may revoke all the provided services, such as U.S. agent appointment, registration, listing, or any other such services, and FDA Agent Pro will not be responsible for any loss faced by the Company as a result of such action.
This form is only for the specific services mentioned in it. If you are looking for U.S. agent services for ANDA, IND, controlled correspondence, or 510 K filings, please contact us.
The FDA has different requirements for U.S. agents and FSVP agents. This form is not for FSVP agent appointments. If you are looking for FSVP agent services, please contact us.
Without our written consent, you must not use FDA Agent Pro as an FSVP agent for adverse event report purposes or our company name on the product labels.
The U.S. agent contract is valid only for the facility’s name and address mentioned in the form. Each facility location requires a separate registration, and you have to pay the U.S. agent service separately. If you have multiple facilities, please contact us.
The company agrees that it will not use FDA Agent Pro's name on its product label as a distributor.
The company agrees that FDA Agent Pro is allowed to send recurring invoices for the renewal of the US Agent, and the company may choose to renew or refuse the services.
The company agrees that it will not use FDA Agent Pro US Agent services beyond the validity period of the US Agent without paying the renewal. In case the company continues using FDA Agent Pro services after the expiration of the US Agent period. FDA Agent Pro shall cancel the registration, and the company is liable to pay the US Agent fee as per the FDA Agent Pro invoiced rate. SERVICES AGREEMENT This agreement is between the FDA Agent Pro LLC, a California corporation, and You, a client. WHEREAS, You desire FDA AGENT PRO LLC to serve as U.S. agent for those food facilities You are required to register with the U.S. Food and Drug Administration (FDA) in accordance with section 415 of the Federal Food, Drug, and Cosmetic Act (FDCA), as amended by the Food Safety Modernization Act, and FDA regulations under Title 21 Code of Federal Regulations (C.F.R.), Part 1, Subpart H; WHEREAS, FDA AGENT PRO LLC desires to act as U.S. agent for your food facilities,as define below. NOW, THEREFORE, in consideration of the foregoing and of the mutual covenants and agreements set forth, the parties agree as follows: 1. Scope of Services: Subject to the terms and conditions set forth herein, FDA AGENT PRO LLC agrees to serve as a U.S. agent as defined in 21 C.F.R. 1.227 for the food facilities identified by you in the Facility Information Form found at Appendix B to this Agreement. You are required to register, to update your registration, to renew your registration, and to cancel your registration pursuant to the FDCA and FDA regulations under 21 C.F.R. Part 1, Subpart H. In accordance with this agreement, You may designate FDA AGENT PRO LLC as the U.S. agent for such food facilities using corresponding information contained in Appendix A to this Agreement.2. Limitation of Services: As U.S. agent for your facilities, FDA AGENT PRO LLC shall serve as a point of contact between your facilities and FDA. FDA AGENT PRO LLC’s services shall be limited to (1) being identified by You as U.S. agent for your facilities in accordance with 21 C.F.R. section 1.232(c)(2), using corresponding information contained in Appendix A to this Agreement; and (2) facilitating communication between your facilities and FDA.FDA AGENT PRO LLC shall not be responsible for ensuring contact among You, your facilities, and FDA, but shall solely provide one potential point of contact. Other than as described in Paragraph 1, no regulatory assistance or counseling of any kind shall be provided to You by FDA AGENT PRO LLC under this Agreement. FDA AGENT PRO LLC shall not serve as your agent in any capacity other than as described in Paragraph 1. 3. FDA AGENT PRO LLC Is Not Your Agent-in-Charge: It is expressly understood and agreed that FDA AGENT PRO LLC is not your agent-in-charge. Accordingly, You retain all responsibility for ensuring that your facilities are registered with FDA in accordance with the FDCA and regulations promulgated thereunder, and for complying with all other applicable requirements under U.S. law including, but not limited to, any requirement to provide information about your facilities or products to FDA or take any specific action with respect to your facilities or products.4. Facility Contact Information: Immediately upon entering into this Agreement, You shall provide FDA AGENT PRO LLC with full and accurate contact information for each and every facility for which FDA AGENT PRO LLC will serve as U.S. agent under this Agreement. If You have multiple facilities, you must submit the Facility Information Form found at Appendix B for each facility for which You have designated FDA AGENT PRO LLC as Your U.S. Agent. You shall notify FDA AGENT PRO LLC immediately of any change or modification to this contact information at the email address provided in Section 7 of this Agreement. Failure to apprise FDA AGENT PRO LLC in a timely manner of such changes or modifications shall render this Agreement null and void.5. Term: This Agreement shall commence immediately upon the receipt of this fully executed Agreement and payment of your annual FDA AGENT PRO LLC renewal fees. This Agreement will renew automatically for successive terms of one year unless terminated pursuant to the terms hereof. 6. Termination: Either party may terminate this Agreement at any time and without cause upon written notice to the other party, which must be provided no less than 60 days prior to such termination. The written notice shall specify the effective date of termination.7. FDA AGENT PRO LLC Contact Information: All correspondences related to this Agreement should be directed to the following email address: info@fdaagentpro.com.8. Indemnity: You shall indemnify and hold harmless FDA AGENT PRO LLC, its officers, directors, employees, servants, agents, affiliates, and members from and against any and all claims, demands, costs, damages, liabilities, losses, actions, assessments, charges, and expenses (including, without limitation, interest, FDA reinspection fees, penalties, and attorneys’ fees and disbursements) which may at any time be suffered or incurred by, or be asserted against, any one or more of them, directly or indirectly, on account of or in connection with this Agreement, except where such claim is based on the gross negligence or willful misconduct of FDA AGENT PRO LLC in satisfying its obligations under this Agreement.9. Assignment: No party shall assign this Agreement without the prior written consent of the other party. Any purported assignment without prior written consent shall be null and void and have no force or effect.10. Governing Text: All disagreements, disputes, and claims of any kind under this Agreement, including any litigation or arbitration of purported claims, shall be governed by and be construed under the English language text of this Agreement.11. Governing Law: This Agreement shall be governed by, and construed in accordance with, the laws of the State of California without regard to principles or conflicts of law.12. Entire Agreement: This Agreement, including the Appendices hereto, contains the entire agreement between the parties with respect to the subject matter hereof and supersedes any and all prior oral or written agreements, commitments, or understandings. No amendment or modification of this Agreement shall be valid or binding unless set forth in writing and duly executed by both parties.
FDA Agent Pro is a private consulting firm that offers U.S. agent services to foreign companies and is not affiliated with the U.S Food and Drug Administration (FDA). By accepting this agreement, the Company agrees to follow the terms:
FDA Agent Pro acts as a U.S. agent for the Company to facilitate communication between the FDA (U.S. Food and Drug Administration) and is only responsible for transmitting the information received from the FDA to the Company unless a specific service agreement exists for different services.
The U.S. agent agreement between the Company and FDA Agent Pro will remain effective for 12 months or 24 months from the date of payment, as per the option selected on the form. Unless extended, this is the period specified.
The fee paid for the US Agent services is non-refundable.
U.S. agent fees do not include any other consulting or regulatory work unless jointly agreed to by both parties.
The company warrants that the information provided in this form is Truthful and Accurate. It remains the Company's responsibility to update any change in the provided information.
The Company acknowledges that FDA Agent Pro is acting as a U.S. Agent between the Company and the Food and Drug Administration and has no involvement or specific knowledge of the Company’s products.
Company will not hold FDA Agent Pro liable for any negligence and/or damages whatsoever, including but not limited to any liability arising concerning the performance of the Company’s products.
Neither party to this contract shall be held responsible for a breach of contract caused by an act of God, insurrection, civil war, military or local emergency, or by any act or failure to act by the U.S. Food and Drug Administration.
In case of any breach of terms, FDA Agent Pro has the right to terminate the services with seven days' advance notice.
In case of non-payment for renewal of services, FDA Agent Pro may revoke all the provided services, such as U.S. agent appointment, registration, listing, or any other such services, and FDA Agent Pro will not be responsible for any loss faced by the Company as a result of such action.
This form is only for the specific services mentioned in it. If you are looking for U.S. agent services for ANDA, IND, controlled correspondence, or 510 K filings, please contact us.
The FDA has different requirements for U.S. agents and FSVP agents. This form is not for FSVP agent appointments. If you are looking for FSVP agent services, please contact us.
Without our written consent, you must not use FDA Agent Pro as an FSVP agent for adverse event report purposes or our company name on the product labels.
The U.S. agent contract is valid only for the facility’s name and address mentioned in the form. Each facility location requires a separate registration, and you have to pay the U.S. agent service separately. If you have multiple facilities, please contact us.
The company agrees that it will not use FDA Agent Pro's name on its product label as a distributor.
The company agrees that FDA Agent Pro is allowed to send recurring invoices for the renewal of the US Agent, and the company may choose to renew or refuse the services.
The company agrees that it will not use FDA Agent Pro US Agent services beyond the validity period of the US Agent without paying the renewal. In case the company continues using FDA Agent Pro services after the expiration of the US Agent period. FDA Agent Pro shall cancel the registration, and the company is liable to pay the US Agent fee as per the FDA Agent Pro invoiced rate. SERVICES AGREEMENT This agreement is between the FDA Agent Pro LLC, a California corporation, and You, a client. WHEREAS, You desire FDA AGENT PRO LLC to serve as U.S. agent for those food facilities You are required to register with the U.S. Food and Drug Administration (FDA) in accordance with section 415 of the Federal Food, Drug, and Cosmetic Act (FDCA), as amended by the Food Safety Modernization Act, and FDA regulations under Title 21 Code of Federal Regulations (C.F.R.), Part 1, Subpart H; WHEREAS, FDA AGENT PRO LLC desires to act as U.S. agent for your food facilities,as define below. NOW, THEREFORE, in consideration of the foregoing and of the mutual covenants and agreements set forth, the parties agree as follows: 1. Scope of Services: Subject to the terms and conditions set forth herein, FDA AGENT PRO LLC agrees to serve as a U.S. agent as defined in 21 C.F.R. 1.227 for the food facilities identified by you in the Facility Information Form found at Appendix B to this Agreement. You are required to register, to update your registration, to renew your registration, and to cancel your registration pursuant to the FDCA and FDA regulations under 21 C.F.R. Part 1, Subpart H. In accordance with this agreement, You may designate FDA AGENT PRO LLC as the U.S. agent for such food facilities using corresponding information contained in Appendix A to this Agreement.2. Limitation of Services: As U.S. agent for your facilities, FDA AGENT PRO LLC shall serve as a point of contact between your facilities and FDA. FDA AGENT PRO LLC’s services shall be limited to (1) being identified by You as U.S. agent for your facilities in accordance with 21 C.F.R. section 1.232(c)(2), using corresponding information contained in Appendix A to this Agreement; and (2) facilitating communication between your facilities and FDA.FDA AGENT PRO LLC shall not be responsible for ensuring contact among You, your facilities, and FDA, but shall solely provide one potential point of contact. Other than as described in Paragraph 1, no regulatory assistance or counseling of any kind shall be provided to You by FDA AGENT PRO LLC under this Agreement. FDA AGENT PRO LLC shall not serve as your agent in any capacity other than as described in Paragraph 1. 3. FDA AGENT PRO LLC Is Not Your Agent-in-Charge: It is expressly understood and agreed that FDA AGENT PRO LLC is not your agent-in-charge. Accordingly, You retain all responsibility for ensuring that your facilities are registered with FDA in accordance with the FDCA and regulations promulgated thereunder, and for complying with all other applicable requirements under U.S. law including, but not limited to, any requirement to provide information about your facilities or products to FDA or take any specific action with respect to your facilities or products.4. Facility Contact Information: Immediately upon entering into this Agreement, You shall provide FDA AGENT PRO LLC with full and accurate contact information for each and every facility for which FDA AGENT PRO LLC will serve as U.S. agent under this Agreement. If You have multiple facilities, you must submit the Facility Information Form found at Appendix B for each facility for which You have designated FDA AGENT PRO LLC as Your U.S. Agent. You shall notify FDA AGENT PRO LLC immediately of any change or modification to this contact information at the email address provided in Section 7 of this Agreement. Failure to apprise FDA AGENT PRO LLC in a timely manner of such changes or modifications shall render this Agreement null and void.5. Term: This Agreement shall commence immediately upon the receipt of this fully executed Agreement and payment of your annual FDA AGENT PRO LLC renewal fees. This Agreement will renew automatically for successive terms of one year unless terminated pursuant to the terms hereof. 6. Termination: Either party may terminate this Agreement at any time and without cause upon written notice to the other party, which must be provided no less than 60 days prior to such termination. The written notice shall specify the effective date of termination.7. FDA AGENT PRO LLC Contact Information: All correspondences related to this Agreement should be directed to the following email address: info@fdaagentpro.com.8. Indemnity: You shall indemnify and hold harmless FDA AGENT PRO LLC, its officers, directors, employees, servants, agents, affiliates, and members from and against any and all claims, demands, costs, damages, liabilities, losses, actions, assessments, charges, and expenses (including, without limitation, interest, FDA reinspection fees, penalties, and attorneys’ fees and disbursements) which may at any time be suffered or incurred by, or be asserted against, any one or more of them, directly or indirectly, on account of or in connection with this Agreement, except where such claim is based on the gross negligence or willful misconduct of FDA AGENT PRO LLC in satisfying its obligations under this Agreement.9. Assignment: No party shall assign this Agreement without the prior written consent of the other party. Any purported assignment without prior written consent shall be null and void and have no force or effect.10. Governing Text: All disagreements, disputes, and claims of any kind under this Agreement, including any litigation or arbitration of purported claims, shall be governed by and be construed under the English language text of this Agreement.11. Governing Law: This Agreement shall be governed by, and construed in accordance with, the laws of the State of California without regard to principles or conflicts of law.12. Entire Agreement: This Agreement, including the Appendices hereto, contains the entire agreement between the parties with respect to the subject matter hereof and supersedes any and all prior oral or written agreements, commitments, or understandings. No amendment or modification of this Agreement shall be valid or binding unless set forth in writing and duly executed by both parties.