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  1. FDA Technology Transfer Program

The FDA Licensing Process

The FDA Licensing Process

The Licensing Process at FDA consists of the following steps:

 The FDA Licensing Process

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  • Submit any necessary Confidential Disclosure agreement for unpublished Patent Application to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: FDAInventionLicensing@fda.hhs.gov
  • 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: FDAInventionLicensing@fda.hhs.gov 
  • 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.