Cosmereg LLC, 7901 4th St. N STE 4016 Tampa/St. Petersburg, FL 33702, USA, privately held company to act as their designated U.S. AgentIn accordance with parts 207, 607 and 807 of the United States Food and Drug Administration (FDA) Code of Federal Regulations (CFR), which states that all foreign businesses involved in producing, processing, packing and/or distributing OTC, Drugs, Food and Medical devices , that wish to import these products for sale within the United States, must do so via a designated U.S. Agent.

Through this agreement, the Company authorizes Cosmereg to act as their designated U.S. Agent in all communication with the FDA. The company hereby agrees for Cosmereg to identify itself as the designated U.S. Agent for the Company before the FDA, to communicate with the FDA on the Company’s behalf, and to discuss protected information with the FDA, relating to the Company or its products.

Services Rendered

As the designated U.S. Agent for the Company, Cosmereg agrees to:

1. Be the registered domicile of the Company in the United States, via its U.S. Address;
2. Act as an intermediary for communication between the FDA and the foreign business;
3. Answer any questions that the FDA may have about the Company or its products in a timely fashion;
4. Help the FDA to coordinate inspections of the foreign business’s manufacturing, processing, packaging, storage or other sites;
5. Receive information from the FDA, in the case that the FDA is not able to contact the foreign business directly.

Our U.S. Agent Agreement includes only the above listed U.S. Agent responsibilities.

Please note that the U.S. agent has no responsibility related to the reporting of adverse events. We provide this service in addition to our US Agent service.

Company warrants that information provided are Truthful and Accurate. It remains Companies responsibility to update any change in the provided information.

Company acknowledges that Cosmereg LLC is acting as 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 Cosmereg liable for any negligence and/or damages whatsoever including but not limited to any liability arising with respect to the performance of the Company’s products.

In order to perform these functions in accordance with FDA regulations, the Company agrees to provide Cosmereg with information, including:

1. Information regarding any new products that are intended to be marketed in the U.S., or any alterations to products that are already available for sale and are listed with the FDA (changes to formulations, change of product name, etc.).
2. Any alterations to the Establishment registration, including (but not limited to) changes to its address, telephone number, ownership or purpose.

Terms of Sale

1. This agreement covers one full year of U.S. Agent service. This includes a maximum of fifteen hours of service at a fix rate paid annually on December.
2. Annual renewal of this agreement will be completed four weeks prior to the date of commencement of the next year of service.
3. The Company agrees to pay 100% of the fee upfront.
4. This service shall renew automatically each year. In the event that the Company should wish to end this agreement and not renew the U.S. Agent service, they must provide written notice to Cosmereg at least  (7) seven working days prior to the renewal date.
5. In case of any breach of terms Cosmereg has right to terminate the services with seven days advance notice. In case of non-payment for renewal of services Cosmeregmay revoke all the provided services such U.S Agent appointment , registration, listing or any other such services and Cosmeregwill not be responsible for any loss faced by Company as result of such action.
6. Either party (the Company or Cosmereg) has the right to terminate this agreement at any time. To do so, they must provide notice by registered mail or through an email sent with a receipt acknowledgement. No refund shall be provided in the event that this service is terminated prior to completion of one full year of service.
7. Regulations for confidentiality and data protection shall be followed at all times. Cosmereg shall not share confidential information with the FDA, or any other party, without prior approval from the Company.
8. Cosmereg is not affiliated or associated to the FDA.
9. This agreement is subject to U.S. regulation. Should any conflict or dispute arise, relating to this agreement or the services detailed above, this shall be resolved in the state of Florida, USA.
10. Company shall hold Cosmereg harmless from and will fully indemnify Cosmereg for any and all claims for penalties, and/or other charges or claims of whatever nature, including fees assessed by FDA or other U.S. government agencies, in connection with Agent’s services.

I have read and fully understand this document. I am aware of my rights and obligations as detailed above. I wish to contract the services of Cosmereg as the designated U.S. Agent in accordance with FDA regulations. I am legally authorized to enter into this agreement on behalf of the Company.