Year One: Ensuring Bayh-Dole Compliance with the New Executive Order

We are rapidly approaching the first full year of utilization reporting in accordance with the Executive Order on Federal Research and Development in Support of Domestic Manufacturing and United States Jobs. The overall intent of this order is to bolster domestic manufacturing, promote innovation and create jobs within the United States.  Keep in mind that NIST deadline for submitting the annual utilization reports is 12/31/24.

Additional Utilization Reporting Requirements

We hear from our clients that it has been a challenge to find the most efficient way to gather the manufacturing data, which was not previously collected from licensees. This additional information includes:

• A comprehensive list of products commercialized as an outcome of federally-funded research.

•  The disclosure of the country and state of manufacture, indicating whether production occurs in the U.S. or offshore.

• The number of units sold (if funded by DOE).

All new license agreements should include the requirements for manufacturing data now reportable to NIST.  Gross revenues generated within the fiscal year continues to be a reporting requirement for federal dollars invested in research.

How to Gather and Report the Data?

Some larger commercial databases, (Inteum for example), have been updated to include the fields to report this manufacturing data with an automatic link to the active agreement record. It goes without saying that in order to use a portal in this fashion, all of the reporting data to-date has to be correct and complete. By generating an email sent directly to the licensees to request the data, universities maintain a record of the outgoing request and populate the fields in iEdison. Tech transfer offices that track compliance data on a homegrown system may find that designating an individual to gather and enter information manually meets their needs.

Implement Your Compliance Plan

What have we learned in this first year is that the challenges faced in gathering and reporting this data underscore the need to establish a systematic process and effective communication between research institutions and their licensees. With a reporting deadline of the end of the year, institutions should have a step-by-step plan in place, per their federal award requirements, and have communicated to their licensees what information is required. Attention to the NIST utilization reporting requirements is a mandate, as is the need to facilitate seamless data submission from all stakeholders involved in the commercialization of federally-funded research.