PREVENT Cancer Preclinical Drug Development Program
IP and Data Access
The following outlines the different patent and licensing mechanisms applicable to studies of third-party agents in the PREVENT Program. Please note that the NCI has a variety of agreement mechanisms by which these terms may be applied and will work with the NCI Technology Transfer Center to determine the appropriate agreement for the studies approved by the PREVENT Program.
Applicants entering the pipeline for projects post lead compound development but prior to clinical trials will be expected to execute a PREVENT MTA (pdf, 64kb). The terms of this agreement will govern the collaboration between the NCI and the applicant for pre-clinical development stage projects.
NCI Employee Inventions
Normally, the NCI will not acquire intellectual property rights to inventions made by its employees using PREVENT Collaborator Materials under PREVENT, unless the PREVENT Collaborator and the NCI mutually agree that to do so would be in the best interest of the PREVENT Collaborator and the invention's further development. The NCI will inform the PREVENT Collaborator of any such inventions, and after consultation with the PREVENT Collaborator, the NCI will decide whether or not to file a patent application on any such invention. If the NCI does file a patent application, the PREVENT Collaborator will be given an opportunity to negotiate for a license in accordance with the procedures set forth in 37 CFR Part 404.
Contract Research Organizations (CROs)
NCI will inform the PREVENT Collaborator of the results of the NCI contractor's or subcontractor's research using the PREVENT Collaborator's Materials.
Inventions made by the CROs are subject to the Bayh-Dole Act; however, to encourage applicants to participate in the PREVENT Program, such NCI contractors and subcontractors have agreed to include as a term and condition of their funding agreements, an agreement to offer to the PREVENT Collaborator a first option to negotiate a license to subject contractor or subcontractor inventions made using the PREVENT Collaborator's Research Material.
Data generated by PREVENT services are stored in highly secure, password-protected databases and file storage systems. All servers are operated by NCI employees or NCI approved contractors, and access is restricted to users who have been approved by NCI to access the data.
Users are instructed that data are not to be shared with any individuals who do not have direct access, with the further constraint that access is granted only on a "need-to-know" basis.
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