Agreement for Drug Establishment Registration with US FDA
We appreciate your decision to select Liberty Management Group Ltd. to register your Drug Establishment with United States Food and Drug Administration as required by 21 CFR Part 207. This Agreement describes the scope of our relationship with your company. By signing below and submitting this form to Liberty Management Group Ltd. your Company agrees to be bound by the terms and conditions listed in this document
1 . Services Provided. Our services will be limited to register your establishment with US FDA. Our services include assisting your company to obtain NDC labeler code also. Liberty Management Group Ltd. will be identified as the "U.S. Agent" and "registrant Contact" for your establishment. You understand and agree that the information you provided will not be privileged or confidential. You also understand and agree that the SPL file may be prepared by LMG or its associates.
2 . Client Information. You agree and warrant that all information that your company provides to Liberty Management Group Ltd. including but not limited to any information necessary to register your establishment and list your drug with the US FDA is true and accurate. You also agree that you will promptly inform any changes in the client information.
3 . Termination Notice. Either Party may terminate the relationship at any time for any reason by providing seven (7) days prior written notice to the other party. In the event of Liberty Management Group Ltd, terminate this agreement Liberty Management Group Ltd, shall not be liable to your company for any reimburesment or damages. In no event shall the Liberty Management Group Ltd's liablility exceed the amount of the fees paid by your company in any given calendar year.
4. Authorization. You authorize Liberty Management Group Ltd. to prepare and submit the SPL file to United States Food and Drug Administration on behalf of your Company.
5 . Limitations. Liberty Management Group Ltd. shall not be liable for any delay in performing its obligations under this agreement, if such delay is caused by circumstances beyond Liberty Management Group Ltd's reasonable control. Liberty Management Group Ltd. will not provide you any guarantee or assurance that the US FDA will accept the data submitted by you. You acknowledge and understand that Liberty Management Group Ltd. will not verify the data submitted by you.