A company that desires a license to develop a NIH invention must complete and submit to OTT an Application For License To Public Health Service Inventions [PDF | WORD]. This application forms the primary basis for licensing decisions. It provides OTT with information about the potential licensee, the type of license desired, some of the terms desired and the potential licensee's plans for development and/or commercialization of the invention. Also, if the applicant desires a license with some form of exclusivity, the completed application provides OTT with the applicant's justification for an exclusive license.

After reviewing the license application, OTT, in consultation with the IC that sponsored the research, determines if the applicant's proposal is consistent with the licensing strategy developed for the invention and whether the grant of the license would benefit the public and be consistent with the interests of the Federal government. If the applicant has requested a nonexclusive license and a favorable determination has been made upon the application by OTT negotiations will begin as appropriate.

If the applicant has requested an exclusive or partially exclusive license OTT will publish a notice in the Federal Register, as required by law, and after a 60 day period will reevaluate the application and all comments received from the public to make a final determination regarding the license. The criteria to be considered in evaluating exclusive license applications (37 CFR §404.7) include whether:

• Exclusive licensing serves the best interests of the public.
• Practical application of the invention is not likely to be achieved under a nonexclusive license.
• An exclusive or partially exclusive license is a reasonable and necessary incentive to promote the investment of risk capital to bring the invention to practical application.
• Exclusive or partially exclusive license terms and conditions are not broader than necessary.
• Exclusive licensing will not lessen competition.