Provider: National Cancer Institute (NCI)
- Provider agrees to transfer to Recipient the following FES Production Documents (click here) for the production of [16-[18F]-fluoro-17-estradiol, [18F]FES
(A) Generic Chemistry, Manufacturing and Control Section
(B) Generic Standard Operating Procedures (SOP)
(C) Example/Template Investigator's Brochure
- The Production Documents will only be used for research purposes by Recipient. These Production Documents shall not be used for commercial purposes. Recipient agrees to comply with all Federal rules and regulations applicable to Recipient's use of Production Documents.
- The Recipient will use the Production Documents only to enable routine synthesis of [18F]FES and to support IND filing or RDRC approved investigation (henceforth "Project")
- In all oral presentations or written publications concerning the Project, Recipient will acknowledge Provider's contribution of the Production Documents unless requested otherwise. To the extent permitted by law, Recipient agrees to treat in confidence, for a period of three (3) years from the date of its disclosure, any of Provider's written information that is stamped "CONFIDENTIAL," except for information that was previously known to Recipient or that is or becomes publicly available or which is disclosed to Recipient without a confidentiality obligation or that is required to be disclosed by law, provided that the Recipient takes reasonable and lawful actions to avoid and/or minimize such disclosure.
- The Production Documents represent a significant investment on the part of Provider and are proprietary to the National Cancer Institute, an agency of the U.S. Government. Recipient therefore agrees to retain control over the Production Documents and further agrees not to transfer the Production Documents to other people not under her or his direct supervision. Provider reserves the right to distribute the Production Documents to others and to use Production Documents for its own purposes.
- The Production Documents are provided as a service to the research community. THE PRODUCTION DOCUMENTS ARE BEING SUPPLIED TO RECIPIENT WITH NO WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. Provider makes no representations that the use of the Production Documents will not infringe any patent or proprietary rights of third parties.
- Recipient shall retain title to any patent or other intellectual property rights in inventions made by its employees in the course of the Project. Recipient agrees not to claim, infer, or imply endorsement by the Government of the United States of America (hereinafter referred to as "Government") of the Project, the institutions or personnel conducting the Project or any resulting product(s). Unless prohibited by law from doing so, Recipient agrees to hold the Government harmless and to indemnify the Government for all liabilities, demands, damages, expenses or losses arising out of Recipient's use of the Production Documents for any purpose.
- The Provider and Recipient expressly certify and affirm that the contents of any statements made herein are truthful and accurate. The Provider acknowledges that it is authorized to enter into this agreement. The Recipient acknowledges that it is authorized to enter into this agreement.
- This Agreement shall be construed in accordance with Federal law as applied by the Federal courts in the District of Columbia.
- This Agreement governs the use of any individual component of the Production Documents, as well the use of the entirety of the Production Documents.
- Recipient agrees that the Production Documents supplied by Provider are for investigational use only and may not be transferred to a third party.
- Upon the request of the Provider, Recipient will destroy or otherwise dispose of the Production Documents and all copies of the Provider's Confidential Information.
- Recipient agrees that the Production Documents supplied will be used in a clinical study only after an approved IND is on file with the FDA and the Office for Human Research Protections (OHRP) assurance has been obtained, as well as all other appropriate approvals, which may include Office of Biotechnology Activities, Institutional Biosafety Committee, and Institutional Review Board. Recipient further agrees that the Production Documents will be used only in accordance with FDA approved clinical protocols and in accordance with FDA IND regulations. In addition Recipient will submit all amendments to clinical protocols to the IRB and the FDA (and other groups as required).
- If the Recipient intends perform a research study in human subjects using the Radioactive Drug Research Committee (RDRC) process under local institutional oversight instead of an IND, the Recipient agrees it will follow all conditions specified in the RDRC regulation (21 CFR 361.1).
Provider's Official and Mailing Address: For Questions Regarding the Terms of this Agreement:
|Cancer Imaging Program||Technology Transfer Branch|
|National Cancer Institute||National Cancer Institute|
|6130 Executive Blvd., MSC 7412||6120 Executive Blvd., Suite 450|
|Bethesda, MD 20892-7412||Rockville, MD 20852-7181|
Any false or misleading statements made, presented, or submitted to the Government, including any relevant omissions, under this Agreement are subject to all applicable civil and criminal statutes including Federal statutes 31 U.S.C. '' 3801 3812 (civil liability) and 18 U.S.C. ' 1001 (criminal liability including fine(s) and/or imprisonment).