Focusing on the use of CRADAs (Cooperative Research and Development Agreements) and PLAs (Patent License Agreements)

• What these agreements are and how to make them work for you.
• The conditions and requirements for the use of CRADAs and PLAs.
• Protecting intellectual property, including proprietary information, data, and patents.
• What can be negotiated by the federal laboratories.
• How the courts have ruled in technology transfer litigation.

This course provides an overview of technology transfer and its applications. The course covers the legislative history and the mechanisms of technology transfer. It focuses on Cooperative Research and Development Agreements (CRADAs) and Patent License Agreements (PLAs). CRADAs are flexible tools used by universities, companies, and others to collaborate with federal laboratories. Through this mechanism, parties can mutually access each other's expertise, resources and facilities. PLAs provide opportunities for participating parties to negotiate successful patent licenses. In sum, these unique R&D instruments offer the prospect of quicker technology development and commercialization.

The course will be presented through a combination of lectures, interactive discussion, and workshops. Upon completion of the course, participants will have gained both a working knowledge of the primary instruments of technology transfer and an understanding of the value and purpose of technology transfer.

1. Origins of Federal Technology Transfer
   1. Ownership of Government-funded inventions
   2. The expansion in Federally-funded R&D
   3. The Stevenson-Wydler Act
   4. The Bayh-Dole Act
2. Overview of Intellectual property
   1. The concept of intellectual property and its importance
   2. Patents, Copyrights, and Trademarks
   3. Government Employee Inventions
3. What is a CRADA
   1. The method to implement Stevenson-Wydler
   2. A federal contract for collaborative R&D
   3. Statutory elements
      1. Federal laboratories and their CRADA resources
      2. Non-federal entities and their CRADA resources
   4. Specified R&D
4. Distinguishing a CRADA From Procurement Contracts and Grants
   1. Differences
   2. Similarities
5. CRADA Authority and Responsibility
   1. Negotiating CRADAs
   2. Avoiding conflict of interest issues
   3. Preference for small businesses and U.S. manufacturing
   4. CRADAs with foreign entities
6. Technology Transfer Issues
   1. How to handle Data Rights
   2. Management of Disputes
   3. Liability and Indemnification
   4. Statement of Work
   5. Reimbursement for travel
   6. CRADAs with federal grantees and contractors
   7. CRADAs with GOCO laboratories
   8. Litigation involving CRADAs
7. Technology Commercialization
   1. The purpose of a license
   2. Types of licenses
   3. How to draft an effective license
   4. Factors to consider in negotiating a license
   5. Government use rights
   6. Types of financial reimbursement
   7. Regulatory issues
   8. Government March-in rights
8. Value of Intellectual Property
   1. Determining the value of intellectual property
   2. Strategies for marketing and maintaining relationships
   3. Intellectual Property audits for effective technology transfer
9. Emerging Technology Transfer Issues
   1. Export Control and Deemed Export regulations
   2. Partnership Intermediaries
   3. State and local resources

Robert L. Charles is an attorney at the Office of Staff Judge Advocate (OSJA), U.S. Army Medical Research and Materiel Command, at Fort Detrick, Maryland, where he is primarily responsible for issues involving Technology Transfer, Assistance Agreements, and Patent Licensing.  He currently serves on the Executive Board and as Chairperson for the Legal Issues Committee of the Federal Laboratory Consortium for Technology Transfer.

Bob came to the OSJA after an active duty career as a judge advocate with the U.S. Army.  Most of his tours were served at Army Medical Department assignments.  He was the initial editor and contributed to numerous articles over the years to the Army’s Medical-Legal Desk book.

Bob earned his undergraduate degree from U.C. Berkeley (Economics), and then attended law school at the University of Utah.  While in the military, he graduated from the Army JAG resident basic and advanced courses.  Bob was also selected by the Army for advanced civilian schooling and earned a Masters in Public Health from the Program in Health and Law for Lawyers, at Harvard University.  Bob is a member of the Utah and Texas State Bars.

Maryam Azarion is an attorney at the Office of General Counsel at the Department of Veterans Affairs where she is responsible for handling various technology transfer issues.  Her previous experiences include working as the Director of the Technology Transfer Office at the U.S. Army Medical Research Institute of Infectious Diseases, Senior Licensing Officer at the U.S. Army Medical Research and Material Command, and Naval Research Labs.  Maryam has an extensive background in licensing, negotiations, and handling technology transfer issues. 

As a former microbiologist and inventor, she brings a unique perspective and several years of practical experience in intellectual property matters, science, management, and an understanding of legal implications of technology transfer.  Maryam has a Masters in biomedical sciences and a law degree.  She is a member of the Maryland Bar.