Online Training 2016 - Negotiating Cooperative Research and Development Agreements (CRADAs) with the US Government

Overview:
This webinar will provide an overview of Cooperative Research and Development Agreement (CRADA) as a mechanism for working with the federal government. The webinar will review the legislative history creating the CRADA as a contract mechanism; describe the structure of CRADA agreement; and outline what the government and the CRADA collaborator can and cannot provide under a CRADA.
The different types of CRADAs will be explored, as well as key contract provisions such as the definition of CRADA subject inventions, the options to license government rights in CRADA Subject Inventions, the statutory license back to the government on all CRADA subject inventions, and the government’s march-in rights.
Participants will gain insight on the importance of the scope of the Research Plan in determining which inventions will be classified as CRADA subject inventions. The webinar will help participants understand both the risks and the benefits of working with the federal technology transfer act under a CRADA.
Why Should You Attend:
The agencies of the federal government have much to offer both to small businesses and major corporations interested in collaborating with the government. The expertise of government staff and access to in-kind resources of the government can help companies develop their technology to bring it to market.
The Cooperative Research and Development Agreements (CRADA) serves as valuable mechanism for companies to gain access to the expertise and resources of the federal government in a way that protects their proprietary interests in their technology. But negotiating with the federal government can be daunting. Understanding the government vernacular and the laws and regulations governing CRADAs is critical to ensuring a CRADA achieves the company’s goals.
Understanding the risks and benefits of the CRADA contracting mechanism is important in determining which projects are best suited for CRADA collaborations and which are not.
Areas Covered in this Webinar:
The webinar will cover the legislative history of the Stevenson-Wydler Act Technology Innovation Act and the Federal Technology Transfer Act that led to the development of the CRADA mechanism as a tool for supporting research collaborators with the federal government.
The types of CRADAs will be explained and the general structure of CRADA agreements will be reviewed. Key CRADA contract provisions will be reviewed, including the definition of CRADA subject inventions, the options for license to the government’s rights in CRADA subject inventions, the statutory license back to the government and the government march-in rights.
The process for negotiation of CRADAs will be reviewed, as well as the various processes for approval of CRADAs by the federal government. Participants will gain insight on the importance of the scope of the Research Plan on determining which inventions will be classified as CRADA Subject Inventions. The webinar will help participants understand both the risks and the benefits of working with the federal government under a CRADA.
Learning Objectives:
Understanding when a CRADA can be used
The different types of CRADAs available
What the federal government can provide under a CRADA and what it can’t provide
Tips for negotiating CRADAs
Risks and benefits of CRADAs
Who Will Benefit:
In- house Counsel
Outside Counsel
Small Business Interests
Scientific Community
Entrepreneurs
Speaker Profile:
Kate Duffy Mazan is an attorney in private practice in McLean, VA. She is the founding member of The Clinical Technology Transfer Group (CTTG). CTTG is a law firm concentrating in technology transfer and regulatory compliance in the clinical setting.
Kate has extensive experience in the negotiation of Cooperative Research and Development Agreements (CRADAs). Prior to entering private practice, Kate worked for nine years at the National Cancer Institute (NCI) within the National Institutes of Health. As a technology transfer professional at NIH she managed the intellectual property portfolio of NCI’s Natural Products Branch, negotiating CRADAs and international agreements with countries in Africa, Central and South America, and the Pacific rim.
Kate also served as the Coordinator, of the Client Centers Unit in NCI’s Office of Technology Development, where she managed and directed the technology development activities for the Office of the Director of the National Cancer Institute and six “client" Institutes. Primary responsibilities included training and management of staff responsible for negotiating a wide variety of technology transfer agreements including Cooperative Research and Development Agreements (CRADAs), Clinical Trial Agreements, Material Transfer Agreements (MTAs) and Confidential Disclosure Agreements (CDAs). Kate began her career at NIH as Chief of NCI’s Cancer Information Service (CIS), a nationwide network of cancer information and education programs located at major cancer centers across the country. In that capacity she was responsible for developing a training program on the conduct of clinical trials to assist information specialists explain clinical research to patients and the public.
Since entering into private practice in 1997, Kate has assisted a variety of companies in the negotiation of CRADAs, government licenses and other technology transfer agreements with the federal government. Her practice also includes a heavy emphasis on clinical research. She and her staff provide transactional and regulatory support to pharmaceutical, biotech, medical device, and dietary supplement companies in the US and around the world conducting clinical research. CTTG provides high volume contracting services for companies conducting clinical trials and as well as regulatory assistance on informed consent, HIPAA, and Good Clinical Practice requirements.
Kate holds a law degree from the Columbus School of Law at the Catholic University of America, Washington, D.C., a Master of Science in Public Health Administration from the University of Massachusetts Amherst, and an A.B. from Stonehill College, North Easton, Massachusetts. Kate is admitted to practice law in Virginia, Maryland, and the District of Columbia.
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