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In-House

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.

 

Dates and Locations

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DAILY SCHEDULE
9:00 AM - 4:00 PM

 

  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 serves as Chief, Medical Research Law,  in 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  served on the Executive Board and as Chairperson for the Legal Issues Committee of the Federal Laboratory Consortium for Technology Transfer from 2002-2010, where, among other activities, he taught (and continues to teach) a CRADA Workshop at the FLC’s national meetings, he was editor of 2009 edition of The Green Book, Federal Technology Transfer Legislation and Policy, and was a member of the editorial board of the FLC’s Technology Transfer Desk Reference. Mr.. Charles came to the OSJA after serving 20 years as a judge advocate with the U.S. Army.  Most of his tours were  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.
Mr, Charles earned his undergraduate degree from U.C. Berkeley (Economics), and then attended law school at the University of Utah.  He also has 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.

MEET YOUR CONTINUING EDUCATION CREDIT REQUIREMENTS
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Certificates of Completion are provided to all seminar participants who attend Federal Publications Seminars courses following the event, upon request.
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All Federal Publications Seminars courses meet the course requirements of the National Contract Management Association’s certification programs. We are a proud Education Partner of the NCMA.
CPE: CONTINUING PROFESSIONAL EDUCATION
Federal Publications Seminars is part of West Professional Development, which is registered with the National Association of State Boards of Accountancy (NASBA) as a sponsor of continuing professional education on the National Registry of CPE Sponsors. State boards of accountancy have the final authority on the acceptance of individual courses for CPE credit. Complaints regarding registered sponsors may be submitted to the National Registry of CPE Sponsors through its website: www.learningmarket.org.
CPE HOURS
This Program is eligible for: 13.0 (CPE) hours of credit
Program Level: Basic
Program Prerequisite: None
Advance Preparation: None
Method: Group-Live
CLP: CONTINUOUS LEARNING POINTS
APPROVED FOR CLP BY
DEFENSE ACQUISITION UNIVERSITY
Defense Acquisition Workforce members must acquire 80 Continuous Learning Points (CLP) every two years from the date of entry into the acquisition workforce for as long as the member remains in an acquisition position per DoD Instruction 5000.66. We will provide you with documentation of points awarded for completing the event.
CLP HOURS
This Program is eligible for: 11.0 (CLP) hours of credit
CLE: CONTINUING LEGAL EDUCATION
States have widely varying regulations regarding MCLE credit. LegalEdcenter is an approved provider in AL, AK, AR, CA, GA, IL, ME, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, VI, VT, WA, WI, and WV. Credit may be applied for in other jurisdictions on request and in accordance with state MCLE rules.
** Please note that because some states are changing their policy on CLE reporting, you will need to fill out the request for credit from Federal Publications Seminars within 10 business days, or we may not be able to issue credits for the program.
CLE HOURS
This Program is eligible for: 11.0 (60 minutes), 13.0 (50 minutes)
100
Basic or fundamental subject matter is covered. Courses are geared to general knowledge or can be taken as a refresher.
200
Specific topics or issues within a topic area are covered. Students should be familiar with terms of art and general concepts concerning the course topic.
300
Workshops and class discussions cover specific subject matter in-depth, and participation is strongly encouraged. Attendees should have at least 2-3 years' experience in the area of study.
400
Courses build upon students' knowledge and experience, and cover complex issues within the subject matter. Should have 4-5 years' mastery of subject for in-depth analysis.
500
Masters-level programs designed for professionals with 5+ years' experience. Courses cover in-depth and technical analysis on specific subjects and updates on current issues.
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Federal Technology Transfer and CRADAs
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