The Licensing Process at FDA consists of the following steps:

 

The Licensing Process at FDA 

• Review the FDA listing of technology abstracts online and select the technology you are interested in licensing
• Discuss the technology with the contact listed on the abstract to confirm the next steps

• Submit any necessary Confidential Disclosure agreement for unpublished Patent Application to
  the Agency-level FDA Technology Transfer Program
    
  E-mail to: [email protected]

• Review the technology with the scientist and the Technology Transfer Specialist
• Review the various types of licenses available for use online
• Submit a  License Application to the Agency-level FDA Technology Transfer Program
    
  E-mail to: [email protected] 

• Include any necessary business development plan with the License Application 

Negotiation of  a Non-Exclusive Agreement

• Non-exclusive licenses, Biological Materials licenses, commercial evaluation licenses do not require public notice
• FDA Technology Transfer Program reviews the License application and negotiates a mutually acceptable agreement 

Negotiation of an Exclusive Licenses

• FDA 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 period, generally no more than 30 days, of public notice in the Federal Register
• Other organizations have this period during which they may object to the exclusive license and/or apply for an exclusive license to the technology
• After the notice and comment period, FDA will consider any objections and notify you of its decision about the license

Reporting

• The signed license will list the specific reporting requirement for the license, which theh office will monitor.