TERMS OF SERVICE

U.S. Agent and Agency Services

USA will serve as the U.S. Agent for Facility and Product Listing, provided that Customer provides USA with all documentation, information, access, and assurances reasonably requested by USA. Customer agrees to provide all necessary documentation and information in English if asked to do so by USA.

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Recitals

Whereas, Customer seeks a validly designated United States (U.S.) agent as part of the establishment registration process of its foreign cosmetic facility or facilities (Facility) and/or cosmetic product or products for purposes of compliance with Section 607 of the U.S. Food, Drug, & Cosmetic Act (FD&C Act), and The Modernization of Cosmetics Regulation Act of 2022 (MoCRA). Whereas, USA is willing to serve as the U.S. agent, and therefore the U.S. Cosmetic Facility and Product Listing Registration Agent (U.S. Agent), as those terms are used by U.S. Food and Drug Administration (FDA), for Facility and Product, provided that Customer provides USA on an on-going basis with all documentation, information, access, and assurances reasonably requested by USA to fulfill USA’s obligations under the FD&C Act and implementing regulations. Whereas, in order to enable USA to operate as the U.S. Agent for Facility and Product, the parties desire to enter this Agreement. Now, therefor, for and in consideration of the mutual promises and covenants set forth herein, and intending to be legally bound, the parties do hereby agree as follows: 

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Term

USA will serve as the U.S. Agent for Facility beginning on the date of this Agreement and for the duration of two years from the date of this Agreement, and for the duration of two years from the date of this Agreement, or until the final day of the year in which this Agreement was entered (the Initial Term), subject to the Termination provisions set forth herein. This Agreement shall be automatically renewed for successive two-year terms thereafter (each a Renewal Term) until and unless either party provides the other party with sixty days prior written notice to the end of the Initial Term or the Renewal Term, subject to the Termination provisions set forth herein.

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USA will serve as the U.S. Agent for Product Listing beginning on the date of this Agreement and for the duration of one year from the date of this Agreement, and for the duration of one year from the date of this Agreement, or until the final day of the year in which this Agreement was entered (the Initial Term), subject to the Termination provisions set forth herein. This Agreement shall be automatically renewed for successive one-year terms thereafter (each a Renewal Term) until and unless either party provides the other party with sixty days prior written notice to the end of the Initial Term or the Renewal Term, subject to the Termination provisions set forth herein.

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Schedule of Fees

• U.S. FDA  Facility Registration and U.S. Agent Service: 745 USD/facility.

• U.S. FDA  Product Registration and U.S. Agent Service: Based on number of products.

• Registration Certificate: Free.

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Prices, Payment Terms, and Non-Payment

Prices. Customer will pay USA the currently applicable fees for U.S. Agent service and related activities if applicable, as set forth in USA’s Fee Schedule in effect at the time the services are performed.

 

Payment Terms.  USA will issue invoices to Customer, and Customer shall pay invoices received from USA in full within thirty days from the date of invoice. 

 

Non-Payment.  In addition to any other rights and remedies USA may have with respect to Customer’s failure to fully and timely pay any amounts due hereunder, any amounts not paid when due shall be subject to an interest charge of seven percent per month computed from the applicable due date or the maximum rate legally permitted, whichever is less.

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Representations & Warranties

Each party represents and warrants to the other party as follows: (i) that it has full power, authority, and capacity to enter into this Agreement and to perform all its obligations hereunder, and (ii) that it is not bound by any other agreement, arrangement, judgment, or order which would be violated as a result of its entering into this Agreement or performing any of its obligations hereunder.

 

Customer’s Representations & Warranties. Notwithstanding any other provision set forth in this Agreement, Customer represents and warrants to USA that Facility and Product complies with all applicable federal, state, and local laws, rules, regulations, and guidance documents, including, without limitation, the FD&C Act and MoCRA and their implementing regulations. Customer agrees to only name USA as the U.S. Agent for Facility and Product after USA has agreed to act as the U.S. Agent for said Facility and Product. Customer agrees to notify USA within five business days of any change in Customer’s compliance history or any change in the compliance history for any supplier of Customer, including, without limitation, any recall of Customer product, any regulatory inspection that identifies compliance deficiencies, or any enforcement action by any federal, state, or local health authority.  

 

USA’s Representations & Warranties. Notwithstanding any other provision set forth in this Agreement, USA represents and warrants to Customer that USA will comply with all laws, rules, and regulations applicable to its functions as the U.S. Agent for Facility and Product. USA will facilitate communication between FDA and Customer concerning Facility and Product. The services performed by USA under this agreement are limited to those required to be performed by a U.S. Agent pursuant to FD&C Act and implementing regulations.

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Force Majeure

In the event, a party is prevented from performing any of its obligations under this Agreement by circumstances beyond its reasonable control occurring after the date hereof, including without limitation, fire, explosion, flood, drought, blackout, closure of borders, riots, sabotage, embargo, terrorism, war or other hostilities, domestic or foreign governmental acts or changes in the law, accident, equipment failure, inability in obtaining facilities or supplies, or labor dispute including a strike or lockout (each a Force Majeure Event), such party’s obligations shall be temporarily suspended, without liability to the other party, to the extent of such inability to perform; provided, however, that a party shall not be relieved of its obligation to make payments as and when due. A party affected by a Force Majeure Event shall give written notice to the other party of the occurrence of such Force Majeure Event as soon as commercially practicable.

 

Indemnity

Customer shall indemnify and hold harmless USA, its subsidiaries, and otherwise affiliated companies, and each of their respective officers, managers, directors, employees, stockholders, partners, members, or other equity holders, agents, and representatives from and against all claims, liabilities, suits, damages, and costs (including attorneys’ and consultants’ fees and expenses incurred to defend against or otherwise in relation to such matters) arising from any and all claims, injuries, losses, damages, costs, fines, or penalties due, in whole or in part, to Facility and Product, including but not limited to claims arising from or related to Customer’s or its suppliers’ growing, farming, manufacturing, processing, packing, holding, transporting, distributing, or storing of Facility and Product, whether past or present, and whether or not related, in whole or in part, to Customer’s compliance with relevant regulatory requirements (“Indemnified Claims”).  Indemnified Claims include, but are not limited to, claims of any third party, governmental or administrative agency, insurers or customers.  Recoverable costs include, but are not limited to, litigation costs, cost of Facility’s inspection or re-inspection, costs of a recall, workplace, environmental response costs, settlement payments, and judgments, including interest. This indemnity shall survive any termination of any underlying agreements or arrangements. Customer agrees reasonably and promptly to cooperate in connection with the defense of any such claim, including by the prompt provision of requested information and documentation, and by access to and testimony by involved personnel. Customer shall advance promptly and periodically payment for the costs of defending against any such claims (including attorneys’ fees and expenses), and will remain responsible for any and all other losses, damages, judgments and other costs as listed above that the indemnified persons may incur or suffer to the fullest extent provided herein.

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Termination

Termination Due to Breach. Without prejudice and in addition to all other lawful rights and remedies, each party shall have the right to terminate this Agreement upon written notice to the other party if such other party materially breaches any of its representations, warranties, covenants, or obligations set forth in this Agreement, and such failure has not been cured within ten business days of receiving written notice from the non-defaulting party reasonably describing such breach.

 

Termination by Mutual Written Consent.  Without prejudice and in addition to all other lawful rights and remedies, the parties hereto may terminate this Agreement at any time for any reason by mutual written consent.

 

Termination by USA.  Without prejudice and in addition to all other lawful rights and remedies, USA shall have the right to terminate this Agreement upon written notice to Customer in any of the following events, each of which constitutes good cause for termination: (i) Customer fails to provide USA with information necessary to fulfill its legal obligations as U.S. Agent; (ii) USA discontinues operations as U.S. Agent; (iii) USA learns of a change in Customer’s status that would adversely impact its ability to lawfully operate as U.S. Agent; or (iv) USA provides Customer with sixty days prior written notice of its intent to terminate Agreement,

 

Scope

Customer understands that USA is a private corporation and is not affiliated with U.S. FDA and that USA does not and will not practice law or render legal advice.

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Severability

Each of the provisions of this Agreement is a separate and distinct agreement and independent of the others; therefore, if any provision hereof shall be held to be invalid or unenforceable for any reason, such invalidity or unenforceability shall not affect the validity or enforceability of the other provisions hereof.

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Counterparts; Signatures

This Agreement may be executed in one or more counterparts for the convenience of the parties hereto, all of which together will constitute one and the same instrument. A signature transmitted by facsimile or other electronic means shall have the same force and effect as an original signature.

 

Governing Law

This Agreement shall be interpreted and enforced in accordance with the laws of the State of New Jersey.

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Modification

No amendment, modification, termination, or cancellation of this Agreement shall be effective unless in writing signed by both parties hereto.

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Additional Recitals

The Parties further acknowledge that this Agreement sets forth the entire understanding between USA and Customer with respect to the matter set forth herein and that its terms, including the Whereas clauses and the definitions contained therein, are contractual and not mere recitals.