FDA Drug Establishment Registration & NDC Form

We appreciate your decision to select Liberty Management Group Ltd. ("LMG") to assist with your FDA Drug Establishment Registration and/or NDC Labeler Code Request as required by 21 CFR Part 207. This Agreement describes the scope of our relationship with your company. By submitting the requested information to LMG, your company agrees to be bound by the terms and conditions listed in this document.

1. Services Provided

Our services will be limited to providing the FDA with information necessary to properly and timely register your establishment with the FDA to comply with the Act. The services will include assisting your company to obtain a Labeler Code (NDC), and to prepare and submit drug establishment registration and drug listing in SPL format. On the registration form required by the FDA, "Liberty Management Group Ltd." will be identified as the "U.S. Agent" and "Official Correspondent" for your company. You understand and agree that the information your company provides to LMG for the purpose of completing and submitting the FDA registration under the Act will not be privileged or confidential information, and will be used for the purpose of completing a public filing with, among other entities, the United States Government. As "U.S. Agent", LMG may receive notices from the FDA on your behalf relating to the filing, and will transmit such notices to you.

2. Client Information

You agree and warrant that all information your company provides to LMG, including but not limited to any information necessary to register your company under the Act (collectively, "Client Information"), is correct and truthful to the best of your knowledge. You understand and acknowledge that LMG will rely upon the Client Information your company provides. You further agree and warrant that you will promptly inform LMG of any changes in the Client Information on the registration form that are required to be updated with the FDA within thirty (30) days of the change.

3. Termination Notices

Either party may terminate the relationship at any time for any reason by providing five (5) days' prior written notice to the other party. In the event of termination of this Agreement by either party, LMG shall not be liable to your company for any reimbursement or damages on account of the loss of prospective or actual sales or profits of your company, or for your company's expenditures, inventory, investments, leases, or commitments connected with the business or goodwill of your company. In no event shall LMG's liability exceed the amount of the fees paid by your company to LMG in any given calendar year.

4. OTC Monograph User Fee Act (OMUFA) — Important Notice

If you have selected OTC Monograph as the drug status for any of your products, please be aware that the OTC Monograph User Fee Act (OMUFA) may impose fees on your company directly. These fees are assessed by the FDA on facilities that manufacture OTC monograph drug products and are the sole responsibility of your company. LMG does not assume any liability for OMUFA fees, assessments, or penalties that may be incurred as a result of your registration. By proceeding with this application and selecting OTC Monograph status, your company acknowledges and accepts full responsibility for any applicable OMUFA fees owed to the FDA.

5. Limitations

LMG shall not be liable for any delay in performing its obligations under this Agreement if such delay is caused by circumstances beyond LMG's reasonable control.

6. Governing Law and Venue

This Agreement and the interpretation of its terms shall be governed and construed in accordance with the laws of the State of Illinois, U.S.A., without regard to its conflicts of laws rules. The parties consent to the sole and exclusive jurisdiction and venue of the Illinois courts in Will County, Illinois, U.S.A.