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.

1. Scope of Services:

The Registrant hereby engages the Agent to provide consulting services related to the licensing, registration, and filing of cosmetic products, as more specifically described in Exhibit A attached hereto (the “Services“).

Agent covenants that:

• it will provide the Services with due care, skill, diligence, and in a professional manner.
• it shall perform the Services promptly so long as all required information, cooperation, documentation, and assistance is provided by the Registrant at all the required times.

2. Compensation:

In consideration of the Services provided by the Agent, the Registrant agrees to pay the Agent the fees outlined in Exhibit B attached hereto. Payment shall be made as set forth in Exhibit B.

3. Term and Termination:

Term:

Unless terminated earlier pursuant to below, the Agreement will commence upon receipt of payment for the Services from Registrant and will continue in full force and effect until December 31, 2024, and thereafter, shall renew automatically for successive terms of one year beginning on each successive January 1st.

Termination for Convenience:

Either Party may terminate this Agreement at any time upon giving written notice to the other Party by U.S. Mail, FedEx, DHL, or UPS overnight delivery service, or by e-mail. If the Registrant terminates this Agreement at any time for convenience, the Registrant shall provide the Agent with such information as will confirm that Registrant’s cosmetic facility registration has been maintained or canceled consistent with the requirements of Modernization of Cosmetics Regulation Act of 2022 (MoCRA).

Termination for Breach:

Either Party may terminate this Agreement in the event of a material breach by the other Party. A “material breach” shall be defined as a failure to perform a material obligation or duty under this Agreement. The non-breaching party shall provide written notice to the breaching party specifying the nature of the breach and allowing 15 days to cure the breach. In the event that the breach is incurable, or if the breaching party fails to cure the breach within the specified cure period, the non-breaching party may terminate this Agreement immediately upon written notice to the breaching party.

Effect of Termination:

All rights and obligations of the parties under this Agreement shall cease, except for, intellectual property, limitation of liability and dispute resolution provisions. Any outstanding payment obligations to the Agent shall remain due and payable. No part of the fees paid to Agent hereunder shall be refunded.

4. Confidentiality:

Each Party agrees to maintain for the duration of this Agreement the confidentiality of all non-public, confidential and proprietary information provided by the other Party and shall not disclose such information to any third party without the prior written consent of the other Party except that the receiving Party shall be entitled to disclose such information to its representatives, employees, officers, professional advisers or as required by law.

5. Assistance from Registrant:

• Registrant will provide Agent with all information, materials, and cooperation necessary or reasonably requested by Agent to fulfill Agent’s responsibilities hereunder.
• Registrant shall inform Agent immediately of any information required to be reported to Food and Drug Administration (FDA) or any other applicable department or authority, including but not limited to, updates and/or changes to registration and listing information.
• Registrant represents and warrants that the information and materials provided by Registrant will be accurate, truthful, genuine and current. If permitted by the implementing regulations of MoCRA, Registrant authorizes the employees and authorized representatives of Agent to submit information to FDA or any other applicable department or authority, including registration and listing information, any necessary or prudent updates thereof, and such other information as Agent believes necessary or prudent for Registrant to submit.
• Agent will forward all communications from FDA to Registrant at the address, telephone number or email address stated above. In the event that Registrant provides e-mail or other written communication modifying or supplementing the Legal Company Name and/or the Company Address identified above, such information may be relied upon by Agent and shall be incorporated by reference.
• Registrant shall not have any claim against Agent for any losses, damages, costs, or expenses resulting from or arising from failure to provide Services by Agent or delay in providing Services or for any missed deadlines or milestones nor shall Agent be held responsible for any additional costs incurred to the Registrant, where such failure or delay or additional costs results without limitation, from any or all of the following:
  1. The act(s) or omission(s) of Registrant
  2. Registrant’s refusal, inability, or delay in providing information or assistance needed.
• Registrant hereby provides the Agent in connection with the Services:
  1. Authorization to use text, graphics, photos, designs, trademarks, logos, videos, or any other materials as provided by the Registrant (“Materials”);
  2. Permission to make changes to any of Materials and to submit to and communicate directly with any third parties and governmental authorities.
• If any personal data is being provided by the Registrant, the Registrant warrants that it has obtained all necessary consents, permissions, and licenses from third parties to process such personal data as required to enable the Agent to perform the Services.

6. Intellectual Property Rights

• “Background Materials” means, any intellectual property (whether registered or not) owned or controlled by Registrant or Agent, respectively, before entering into this Agreement or developed or acquired by Registrant or Agent respectively, other than in connection with this Agreement and any derivatives, improvements or modifications of the foregoing. Registrant and Agent each shall retain ownership of all rights, title, and interest in its Background Materials. Registrant grants Agent a non-exclusive, royalty-free, sublicensable, and limited right to use its Background Materials for the purpose set out in this Agreement.
• “Work Product” means all reports, deliverables, materials, and all documentation which Agent, within the scope of Services, creates, reduces to practice, or causes another to create, or reduce to practice expressly for the Registrant. All ownership rights in the Work Product and intellectual property rights therein vest in the Agent. The Registrant shall have the right to use such Work Product for the purposes for which it was produced. Unless agreed otherwise in writing, no Work Product may be circulated publicly or used for marketing purposes. If Registrant wishes to distribute copies of Work Product outside its organisation, Agent’s prior written consent shall be obtained.
• Registrant hereby grants Agent the right to use the name and service marks of Registrant in its marketing materials or other oral, electronic, or written promotions, which shall include naming Registrant as a client of Agent and a brief scope of services provided.

7. Disclaimer

• Agent shall act only as a conduit for submission of information and documentation provided by the Registrant and shall not be responsible for the substance thereof. Agent does not practice law or render legal advice. Registrant acknowledges that Agent is a private registration agent not affiliated with FDA.
• Agent does not guarantee approval of any applications related to cosmetic facility registration and/or listing of registrant’s cosmetic products. The approval of such applications depends on multiple factors including meeting the eligibility criteria mandated by the authorities to whom the applications are submitted and Agent does not have control over any such factors. It is the sole responsibility of the Registrant to fulfill the eligibility criteria and qualifications, as mandated by the applicable authorities, and Agent does not provide any advice (including any legal or tax advice) or guidance on such matters or any aspect of the services.
• Registrant is solely responsible for the submission of required documents accompanying the relevant applications in a timely manner to the Agent to ensure applications are submitted.
• Registrant acknowledges that delay in submission of necessary information by Registrant or any submission of inaccurate information will negatively impact the approval of the concerned applications by the authorities.
• Any Work Product may have been created or modified using or relying on information supplied to the Agent from the Registrant and from otherwise publicly available sources. Unless otherwise agreed in writing by the Parties, the Agent does not have any obligation to investigate or confirm the completeness or accuracy of any such information supplied to the Agent from, the Registrant and from otherwise publicly available sources.  Agent does not warrant that the Services will be error-free or that Agent will correct all errors.

8. Liability

Registrant agrees to reimburse, defend, indemnify and hold harmless Agent from and against any and all expenses, costs and claims, including claims by third parties and nonparties, including but not limited to any governmental agencies, and related costs and attorneys’ fees, whether such claims are alleged in tort, contract or under other law, arising out of or in connection with this Agreement, the transactions contemplated hereby, any claim connected to the business or operations of Registrant, or any breach of law by Registrant. Registrant waives any and all claims against Agent arising out of or in connection with this Agreement except for willful misconduct or gross negligence and for those waives its claims to the fullest extent the law permits.

TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW AND EXCEPT FOR THE INDEMNIFICATION OBLIGATIONS SET ABOVE, NEITHER PARTY SHALL BE LIABLE FOR ANY INDIRECT, PUNITIVE, SPECIAL, EXEMPLARY, INCIDENTAL, CONSEQUENTIAL, OR OTHER DAMAGES OF ANY KIND OR LOST PROFITS OR LOST BUSINESS OPPORTUNITIES, REPUTATION, LOSS OF DATA OR INFORMATION OR CONTENT ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT.

IN NO EVENT SHALL THE AGGREGATE LIABILITY OF AGENT FOR ALL CLAIMS RELATED TO THIS AGREEMENT EXCEED THE TOTAL AMOUNT OF FEES RECEIVED BY AGENT FROM THE REGISTRANT DURING THE LAST THREE (3) MONTHS PRECEDING THE DATE OF CLAIM.

As used in this clause, “Agent” shall include Registrar Corp, its successors, assigns, affiliates, parents, subsidiaries, officers, directors, shareholders, agents and employees.

9. Warranties

Both Parties represent and warrant that

• They have full right, power, and authority to enter into this Agreement and perform the acts required of it hereunder.
• When executed and delivered by them, this Agreement will constitute a legal, valid and binding contract as per terms stated herein

10. Force Majeure

Except for any payment obligations of the Registrant, neither Party to this Agreement shall be held responsible for breach of this Agreement nor be liable for any failure to perform or delay in performance of its obligations under this Agreement due to causes beyond its reasonable control, including but not limited to an act of God, fires, floods, natural disasters, epidemics, pandemics, insurrection, war, military operation, riots, labor disputes, strikes, terrorism or local emergency, or by any act or failure to act by FDA, governmental actions, and any other similar events.

11. General

• Time shall not be of the essence for Services to be rendered by Agent under this Agreement.
• This Agreement, together with the Exhibits attached hereto and incorporated herein by reference, contains the entire agreement between the Parties, and may not be modified except by written agreement executed by both Parties. Notwithstanding any order form, purchase order, or similar document issued by the Registrant, it is expressly agreed that the terms and conditions of this Agreement shall prevail and govern the relationship between the Parties. In the event of any conflict or inconsistency between the terms of this Agreement and any terms contained in any order form, purchase order, or similar document issued by the Registrant, the terms of this Agreement shall take precedence.
• This Agreement shall be construed, and the legal relations between the Parties determined, in accordance with the laws of the State of New York, without giving effect to its choice of law provisions. Any action or proceeding arising out of or in connection with this Agreement or the transactions contemplated hereby shall be brought in the courts of New York or the U.S. District Courts for the Southern or Eastern Districts of New York. The Parties hereto consent to exercise of in personam and subject matter jurisdiction by the courts of the State of New York, and the U.S. District Courts for the Southern or Eastern Districts of New York.
• In the event that any dispute or legal action arises out of or is related to this Agreement, the prevailing party in such dispute or legal action shall be entitled to recover its reasonable attorney fees, court costs, and other legal expenses incurred in connection with the resolution of such dispute or legal action from the non-prevailing party.
• Agent may engage subcontractors in the provision of all or part of the Services, provided, however, Agent shall remain primarily liable for the performance of all subcontracted obligations and shall remain Registrant’s sole point of contact under this Agreement.
• Neither Party shall assign this Agreement or any part thereof to any other party without the prior written consent of the other Party, except that a Party may assign this Agreement without such consent to its successor in interest by way of merger, acquisition, or sale of all or substantially all of its assets.
• This Agreement is not intended to and shall not be construed to give any third party any interest or rights (including, without limitation, any third-party beneficiary rights) concerning or in connection with any provision contained herein or contemplated hereby.
• Agent is an independent contractor, and each Party agrees that no partnership, joint venture, or employment relationship exists between the Parties. As an independent contractor, the mode, manner, method, and means used by Agent in the performance of Services shall be of Agent’s selection and under the sole control and direction of Agent.
• If any provision of this Agreement shall be found invalid or unenforceable, the validity, legality, and enforceability of the remaining provisions shall not in any way be affected or impaired thereby.
• Both Parties shall comply with all applicable laws, rules, and regulations (including anti-corruption and antibribery laws) concerning the provision and use of the Services and provide cooperation to the other Party to comply with such laws.
• Each Party shall act in good faith in all matters under this Agreement acting fairly, honestly, reasonably, and consistently with the reasonable expectations of the other Party.
• The persons signing below represents and warrants that they are the owner, officer, or employee of the Party with authority to make binding commitments on behalf of the Party.

Accepted and Agreed.

Exhibit A- Services

The Agent shall provide the following services subject to the terms and conditions of this Agreement, the MoCRA and any related implementing regulations thereto:

The services include:

1. Serving as Registrant’s required U.S. Agent with the U.S. Food and Drug Administration (“FDA”),
2. Advising and assisting Registrant in connection with the filing of cosmetic facility registration,
3. Advising and assisting Registrant with the listing of Registrant’s cosmetic products as set forth on any accompanying order form.

The services performed by Agent under this Agreement are limited strictly to those listed herein and do not include any other services, including but not limited to, services related to suspensions, recalls, reporting to FDA of adverse events, including fragrance and/or flavor ingredients that may be related to an adverse event, or corrections and removals related to any of the foregoing. Registrant represents and warrants it shall conduct such obligations and report any such events to the FDA without Agent’s assistance.

The services performed by Agent under this Agreement are limited to those required to be performed by a U.S. Agent of foreign cosmetic manufacturers and those required to be performed pursuant to relevant provisions of Section 607 of MoCRA.

Agent may perform additional services in its discretion at Registrant’s written request for additional fees.

Exhibit B-Compensation

Agent’s fee shall be paid in accordance with Agent’s standard fee schedule and any modifications or revisions thereto. The current standard fee schedule is specified below.

USD 450 per year

In addition to the fees above, the Registrant will reimburse Agent for any reasonable and approved out-of-pocket expenses, incurred by Agent in connection with the performance of the duties under this Agreement.

All fees are exclusive of any taxes including but not limited to sales tax, value-added tax, which shall be charged to the Registrant.

Agent reserves the right to suspend the provision of Services without notice and any further liability to the Registrant or any third party if the Registrant is in arrears for more than thirty (30) days until such payments with any interest due thereon is paid in full.

In the event of collection enforcement, Registrant shall be liable for any costs associated with such collection, including, but not limited to, legal costs, attorneys’ fees, courts costs, and collection agency fees.

Any fees due but not paid will bear interest to the extent permitted by applicable law monthly computed from the date the payment is due.

The above fees are based on the initial requirements provided by the Registrant.  Should the requirements change at any time, the Registrant shall pay Agent additional fees for providing services concerning the changed/supplementary requirements.

Any fees (such as filing fees, and registration fees) that need to be paid in connection with the filing of applications are the sole responsibility of the Registrant