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Best Practices for Fast-Tracking Your U.S. Manufacturing Waiver Application for Federally Funded IP

Format: On-Demand Video, DVD, or PDF Transcript
Originally presented: April 11, 2013
CLE credits available. Click here for details.

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In today’s global economy, investors, partners, and licensees may find themselves shying away from companies that rely on an exclusive license from a university because of the “preference to U.S. manufacturing” requirement when federal funding is involved. However, a waiver of this requirement can be obtained if U.S. manufacturing is not commercially feasible or if the university is unable to find a licensee that can — or will — engage in U.S. manufacturing.

Since manufacturing activities in industries such as electronics, medical devices and consumer products are mostly conducted outside of the U.S., the waiver process is an attractive route for exclusive licensees. But, it’s no easy task and waivers are issued sparingly. And if you don’t dot every “i” and cross every “t”, the approval process can drag on, opening up the risk that the market and hungry competitors will pass you by while you’re IP is stuck in a tangle of red tape.

Ami Gadhia, JD, LLM, CLP, a technology portfolio director at the Johns Hopkins Technology Transfer Office, has found a way to taper down the months-long application process and has compiled a successful track record in securing waiver approvals — a very rare achievement. She is ready to share her best practices with you in this nuts-and-bolts one-hour program, where she will share her insight regarding:

  • Who needs to apply for the waiver 
  • Understanding the march-in rights of the funding agency
  • How this process can breed opportunity for additional license agreements
  • Best practices for shaving months off the application process
  • Advice on how to properly answer the application questions for quicker approval times.

PLUS! We’ll provide a sample application for you to take away!

Your Expert Presenter:

Ami D Gadhia, JD, LLM, CLP
Portfolio Director- Physical Sciences & Engineering
Johns Hopkins Technology Transfer Office

Ms. Gadhia’s role is to lead and grow the JHTT Physical Science portfolio in order to demonstrate the increasing value of Johns Hopkins’ innovation to internal and external customers. She accomplishes this by cultivating excellent relationships with faculty and managing one of the largest and most technologically diverse case dockets comprising bioinformatics, medical devices, software, educational evaluation tools, and other physical science technologies. She has developed strong corporate relationships and serves as a liaison with JHU School of Engineering. Ms. Gadhia also evaluates inventor disclosures and identifies commercial scenarios for strategically marketing technologies. She has successfully received numerous NIH manufacturing waivers on behalf of JHTT.

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CLP Credits
All Technology Transfer Tactics' professional development courses and designated educational offerings on the topics of licensing, technology transfer, and technology commercialization at Technology Transfer Tactics' conferences or meetings are eligible for CLP continuing education (CE) credits for certification renewal.

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