Exclusive License Agreements

Exclusive Patent License Agreement

• Exclusive licenses are available, when appropriate, to promote successful commercial development of an invention;
   
• An exclusive patent license agreement with the NIH will be based on the model Exclusive Patent License Agreement adopted by the U.S. Public Health Service (PHS) Technology Transfer Policy Board for use by the National Institutes of Health (NIH);
   
• A company that wants a license to develop an NIH invention must complete and submit an "Application For License To Public Health Service Inventions" to the NCI Technology Transfer Center (TTC). It is important for the applicant to completely and comprehensively fill out the license application before submission.

Exclusive License Process:

• TTC evaluates the license application using a number of criteria to determine if an exclusive license is warranted (see 37 CFR §404.7);
• Exclusive Licenses are subject to a public comment period, generally 15 days, via publication of a public notice in the Federal Register;
• During the Federal Register Notice period, other organizations and individuals may object to the proposed grant of an exclusive license and/or apply for a competing license to the technology. The Federal Register Notice requirement will be waived for a CRADA Collaborator that files an exclusive license application for a CRADA Subject Invention if the CRADA Collaborator elects and files the license application within the time period laid out in the CRADA;
• After the notice period, the TTC will review and consider any objections and comments, and notify the applicant of its decision regarding the proposed grant of an exclusive license.