Agreement for Drug Listing with US Food and Drug Administration
We appreciate your decision to select Liberty Management Group Ltd. to list your drug or drugs with United States Food and Drug Administration. 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 prepare the SPL file from the data you provided in this form and submit it to the United States Food and Drug Administration via Electronic Submission Gateway (ESG). Liberty Management Group Ltd. will not verify the data or the product labeling submitted by you. Liberty Management Group Ltd. provides Electronic Submission assistance only.
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 list your drug with the US FDA is true and accurate. You understand and agree that the information you provided will not be privileged or confidential. You also understand and agree that the SPL may be prepared by LMG or its associates.
3. 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.
4. 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 or Label submitted by you. You acknowledge and understand that Liberty Management Group Ltd. will not verify the data or the product labeling submitted by you.