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    • “ T” Stands for Teamwork and for Technology Transfer : Resources for Acquisition Officers Michael R. Mowatt, Ph.D. , Director, Office of Technology Development and Richard Lambert, J.D. , Consultant National Institute of Allergy and Infectious Diseases National Institutes of Health U.S. Department of Health and Human Services
    • “ Who am I? Why am I here?” - Vice Admiral (retired) James Bond Stockdale, 1992 Vice Presidential candidate of the Reform Party and running mate of H. Ross Perot, during 1992 Vice Presidential Debate
    • Take Home Messages
      • NIH’s technology transfer community is a resource available to you
        • Legal, business and scientific expertise to help you understand intellectual property and data rights and their relevance to your contracting project
        • TT and acquisitions have a lot in common
      • Project requirements must drive the contract terms
        • a sound SOW and clear description of deliverables form the foundation of an effective contract
      • Effective contracts are not accidents
        • they result from collaboration and highly effective communication among members of a NIH team
    • Today’s Agenda
      • Technology Transfer
      • Collaboration, Teamwork and Communication
      • Nuts and Bolts
        • SOW and Deliverables
        • Intellectual Property
        • Data
        • Determination of Exceptional Circumstances
      • Questions
    • What is Technology Transfer?
    • Technology Transfer
      • Public institutions
      • - Government agencies & universities
      • - B asic research
      • Private industry
      • - Applied research
      • - Product commercialization
      Technology Transfer
    • Science Business Law Technology Transfer At the Intersection of Disciplines
    • Technology Transfer at NIH: Shared Responsibilities
      • Institute/Center Technology Development Coordinator (TDC)
        • Employee Invention Reports
        • Transactional agreements (CDA, MTA, CTA, CRADA)
        • Institute IP issues
      • NIH Office of Technology Transfer (OTT)
        • Patenting of technologies arising from ICs
        • Licensing of patents and tangible materials from ICs
        • PHS Technology Transfer Policy
    • Other Contributors to NIH TT
      • Office of the General Counsel (OGC)
        • Organized under DHHS
        • NIH office headed by NIH Legal Adviser
      • Office of Policy for Extramural Research Administration (OPERA)
        • Organized under NIH OD, OER
        • Includes DEITR, Division of Extramural Inventions and Technology Resources, with oversight for reporting of extramural inventions (Interagency Edison)
    • The National Institute of Allergy and Infectious Diseases
    • About Us
      • J.D., M.B.A., M.S., Ph.D., and combos
      • Patent agents and attorneys
      • Former patent examiners (USPTO)
      • Research and R&D experience in industry, academia, government
      • Business development and technology licensing experience
      • Paralegal and administrative experience
    • Who We Are – Part 1 NIAID Mission: To conduct and support research that strives to understand, treat and ultimately prevent the myriad infectious, immunologic, and allergic diseases that threaten millions of human lives
    • Who We Are – Part 2
      • NIAID’s subject matter experts on technology transfer and intellectual property
      • NIAID’s resource for the negotiation and management of “technology transfer” and other transactional agreements
      • NIAID’s “patent department” responsible for oversight and management of NIAID’s intellectual property portfolio and licensing activities
    • What We Do
      • Negotiate and manage agreements to govern collaborations and the exchange of materials and information by NIAID staff (e.g., MTAs, CDAs, CRADAs, CTAs, MOUs, IAAs)
      • Ensure that the provisions of these agreements comport with applicable laws, regulations and policies
      • Support the development of EM program solicitations and NIAID acquisitions
      • Manage NIAID’s patent portfolio
    • Steps to Creating an Effective Transactional Agreement
      • Understand goal(s) of project
      • Define project requirements
        • Research Plan
        • What is needed
          • Materials
          • Data or other information
          • Other?
        • Anticipate
          • Dissemination of results (publication)
          • Disposition of new materials and inventions (patents)
      • Structure the agreement to meet the project requirements
    • Science Business Law Technology Transfer At the Intersection of Disciplines
    • Collaboration: The act of working together, especially in a joint intellectual effort, to achieve common goals Collaboration = Relationship Relationship = Communication
    • Attributes of Successful Collaboration
      • Understanding, respect and trust
      • Common goals
      • Mutual benefits
      • Complementary contributions
        • Subject matter expertise
        • Familiarity with applicable rules
        • Skills required for the jobs at hand
    • Anatomy of a Research Collaboration Agreement
      • Research Plan
        • Goal(s)
        • Plan to achieve the goal(s)
      • Terms and Conditions
        • Confidentiality and publication of results
        • Transfer/exchange and use of materials
        • Ownership and disposition of intellectual property rights and data
        • Other requirements of the parties
    • Steps to Creating an Effective Contract
      • Understand goal(s) of project
      • Define project requirements
        • Statement of Work (SOW)
        • Deliverables
          • Materials
          • Data
          • Software
          • Other, e.g., draft reports, final reports
      • Structure the agreement to meet the project requirements
    • Nuts and Bolts
      • Deliverables
      • Intellectual property (IP)
      • Data Rights
      • Determination of Exceptional Circumstances
    • What’s the difference between a SOW and a deliverable?
      • Statement of Work ( SOW ) defines the work to be performed by the contractor
      • Deliverables include tangible materials, data, software, and other things produced by the contractor in performance of the SOW that the contractor must deliver in order to fulfill its contractual obligation to the USG
    • Shouldn’t we describe deliverables vaguely to increase our flexibility?
      • In general it is advantageous to have a well defined list of deliverables, especially data deliverables, in order to meet the contract objectives
      • If the definition of the deliverable is too vague, you may not get what you want and/or it may cost you more ($$ and time) to get what you want
    • Who owns contract deliverables?
      • In general, the USG owns the deliverables, BUT it depends on what the contract says
      • It is essential to clearly define and, to the extent possible, to list deliverables in the contract
    • Who can use contract deliverables?
      • In general, the USG can use the deliverables, BUT it depends on what the contract says
        • Certain data deliverables may be delivered with limited or restricted rights
      • In general, the contractor can retain and use deliverables for its own purposes, BUT it depends on what the contract says
    • What happens if the contract is not clear about deliverables?
      • Contractor may argue that it owns the materials and has no obligation to deliver them to the USG
      • Disputes and possibly litigation can result
      • The contract should be very clear on this
    • What is intellectual property?
      • Protectable creation of the mind
      • Intangible personal property created by law
      • Examples
        • Patent
        • Copyright
        • Trademark
        • Trade Secret
    • What is a patent?
      • Statutory property right authorized by the US Constitution and granted by the USG
      • Reward to inventors for publicly disclosing their inventions
      • Time-limited right to exclude others from making, using, selling, offering for sale, or importing the patented invention
      • Does not give the owner the right to practice the invention her/himself
    • Who owns patents made under a USG contract?
      • Under the Bayh-Dole Act of 1980, implemented by FAR 52.227-11, contractors have the right to elect to retain title to inventions they make under Government R&D contracts
      • Such inventions are subject to non-exclusive irrevocable license to the Government and March In rights
    • What rights in data are available to the USG?
      • FAR 52.227-14
        • Normally, USG obtains unlimited rights in data first produced under the contract
        • Contractor can withhold its privately developed data and provide form, fit and function data
        • Use of Alternates II and III may require delivery of marked copies of data that would have been withheld - USG rights are subject to the markings.
      • FAR 52.227-17, Special Works
        • USG can obtain assignment of rights in data and copyright
        • Clause should NOT be used if the contractor will be using proprietary data under the contract.
    • Does the contract guarantee the USG’s right to use data made by a contractor?
      • It depends on what the contract says
      • Simply paying for the development of data does NOT provide the USG with rights in that data
      • Unless the contract is clear, the contractor may not be required to deliver such data to the USG
    • What data rights clause should always be in a contract?
      • FAR 52.227-16 Additional Data Requirements can be a lifesaver
        • Allows the Contracting Officer at any time during the contract performance or within 3 years after acceptance of all items to be delivered under the contract, to call up any data first produced or specifically used under the contract
        • Provides safety net in the event you forgot to ask for certain data
    • What is a DEC?
      • Determination of Exceptional Circumstances
      • Under Bayh-Dole, contractors normally are allowed to elect to retain title to inventions they make under Government funding agreements (R&D contracts), however, the law provides that the contractor’s right can be limited when the Government determines that exceptional circumstances exist
    • When can and should a DEC be used?
      • DEC may be appropriate where a limitation on the contractor’s rights is necessary to accomplish programmatic objectives
        • For example, to entice drug developers to subject their proprietary compounds to screening by USG contractor
        • Often, such developers will not provide the materials because of a concern that the contractor will invent a new method of using the materials
      • REMEMBER : DEC’s should only be used when there is a demonstrated need!
    • I think I need a DEC. How do I go about getting one?
      • Consult your IC’s TDC office
        • Determine whether a viable alternative exists
        • If appropriate, initiate proceedings!
    • Who’s on your team?
      • Contracting Officer
      • Contracting Officer
      • Program/Project Officer
      • NIH Technology Transfer Community
    • Resources
      • NIAID Office of Technology Development
      • www.niaid.nih.gov/ttb/ttb.htm
      • PHS Technology Development Coordinators
      • ott.od.nih.gov/nih_staff/tdc.html
      • NIH Office of Technology Transfer
      • ott.od.nih.gov
    • Questions?
    • “ T” Stands for Teamwork and for Technology Transfer : Resources for Acquisition Officers Michael R. Mowatt, Ph.D. , Director, Office of Technology Development and Richard Lambert, J.D. , Consultant National Institute of Allergy and Infectious Diseases National Institutes of Health U.S. Department of Health and Human Services