Agreement for Self-Identification of Drug Establishment with US FDA
We appreciate your decision to select Liberty Management Group Ltd. to “self-identify” your Drug Establishment with the United States Food and Drug Administration as required by the Generic Drug User Fee Amendments of 2012. 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 preparing and submitting the GDUFA Identification SPL file to FDA from the data provided by you. Liberty Management Group Ltd. will be identified as your establishment's "registrant Contact.”
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 prepare and submit the Self-Identification SPL file 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 five (5) days prior written notice to the other party. If Liberty Management Group Ltd terminates this agreement, Liberty Management Group Ltd shall not be liable to your company for any reimbursement or damages. In no event shall Liberty Management Group Ltd's liability 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 the 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.