Rules and Regulations:

Award letter

Your award letter (sent via email to the project’s Principal Investigator) represents the legal agreement for your Phase I award.

Terms and conditions

You can find the terms and conditions for your SBIR/STTR project linked in your award letter. Terms for SBIR/STTR are located here: https://www.nsf.gov/awards/managing/sbirsttr_conditions.jsp.

Registering your intellectual property

Per the Bayh-Dole Act, any intellectual property (IP) resulting from your work under this award must be registered with the iEdison database at the National Institutes of Health (NIH). You own the IP but you must register it. The Bayh-Dole Invention Step Guide gives you instructions on how to register your IP.

Guidelines for using iEdison: (https://era.nih.gov/iedison/iedison_Inventor_userguide.pdf).

Instructions for the timing of registration of your invention: https://era.nih.gov/iedison/invention_timeline.htm.

What is the Bayh-Dole Act?

The Bayh-Dole Act, 35 U.S.C. 200 et seq, provides that a small business may retain the entire right, title, and interest throughout the world to each subject invention (as defined in 35 U.S.C. 201) subject to the provisions of 35 U.S.C. 202 and 35 U.S.C. 203. With respect to any subject invention in which the awardee retains title, 35 U.S.C. 202(c)(4) gives the Federal government “a nonexclusive, nontransferable, irrevocable, paid-up license to practice or have practiced for or on behalf of the United States the subject invention throughout the world.”

Section 203 of the Bayh-Dole Act gives the U.S. government the ability to exercise “march-in rights” on inventions created by Federally funded research projects. However, these rights are designed to be used only in the case of a national emergency (defined in the Act). Information regarding these rights and the government’s ability to exercise them is located at: https://fas.org/sgp/crs/misc/R44597.pdf.

Regulations implementing the Bayh-Dole Act can be found at: https://grants.nih.gov/grants/bayh-dole.htm.

Note that STTR projects are required to include an Allocation of Intellectual Property Rights Agreement between the awardee small business and the cooperating research institution which provides clarity of ownership of intellectual property that results from the project.