Tim Wittig, Principal, Technology Management Advisors, Science

January 27, 2018 | Author: Anonymous | Category: Science, Health Science, Immunology
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Working With Federal Laboratories Tim Wittig Principal Technology Management Group SAIC 202/841-0655 n [email protected]

Some Background • Federal Laboratories are those Federal organizations where a substantial amount of the equipment and facilities are dedicated to Research, Development, Testing and engineering. • There are 720 “laboratories” throughout the nation. – Of these, 150 are DoD laboratories – Central Region 33 Labs – In Texas, 6 Labs, 2 Major ranges, 1 Depot.

• A individual, company, or University can use the scientists, engineers, equipment, and facilities for private purpose.

Some Important Factors • Federal Laboratories were created for Government purposes. – There is no direct road map to capabilities in a particular lab. – Each has its own processes and schedules that dictate the pace of activity.

• Federal Laboratories are under extreme budget pressure so are very interested in new partners • Federal laboratories have broad pricing flexibility – Use rates for very complex equipment are reasonable – avoiding expensive purchases or leases that tie up capital. – Federal scientists and engineers are not costly and are not permanent employees – reducing burn rates

How can I reach these capabilities • Cooperative Research and Development Agreements • Test Services Agreements • Educational Partnership Agreements • Partnership Intermediary Agreements • Facilities Use Agreements • Arsenal Act and ASPI • Intergovernmental Personnel Transfer Act • Intergovernmental Service Support Act

A CRADA Allows for Commercial Purpose Use, by Private Sector Organizations, of Federally Owned : Know-How, Expertise and Materials • Facilities and Equipment; and • Government Employees Goal for the Gov. • To Strengthen the U.S. Economy and • To Advance The Laboratory Mission • Goal for Partner: • To Advance Toward Commercialization as cheaply as possible •

CRADAs – The Basics • Requires at least 1 Federal lab and 1 Non-Federal Org. • Activity Proposed is Within The Mission of the Lab • Requires Joint Research, Development, Engineering, or Testing • Government may give to its private sector partner the use of : – – – –

Intellectual Property Time of Scientists and Engineers The Use of Materials, Facilities and Equipment No Money

• Private Sector may transfer the same plus Money • Usually lengthy negations but most flexible

Use of Major Range and Test Facilities • 10 USC 2681 • Major range and test facilities may provide commercial test and evaluation services for a commercial organization • Interruption of activity must be allowed in national interest, etc. • Cost must include at least the direct costs and indirect costs as DoD my desire • Funds remain at the installation • Results not immune from FOIA

Working Capital Fund Activities • 10 USC 2563 • A working capital funded industrial facility may sell articles and services made or provided by government workers to a commercial entity if: – The item or service is not available from a commercial source • Time, location, all services available

– The Government is held harmless – There is no interference with the Mission

• All funds received remain with the organization providing the work. • Mostly Navy with Army Depots.

• Silent on IP so FOIA possible without protective language

Test Services Agreements Basics For DoD Labs

• “Test Service Agreement “(10 USC 2539b). – A Government lab may test materials, equipment, models, computer software, and other items for a Private Party; – Government Employees or Its Support Contractors Must Perform All Testing – Fully Loaded Costs Must be Captured – Flexibility coming soon

– The TSA is a Short Agreement Quickly Entered Into. BUT, significant changes are coming!

New Implementing Instructions soon to be Signed a.

Sell, rent, lend, or give samples, drawings, and manufacturing or other information (subject to the rights of third parties and the restrictions in paragraph C.2) to any person or entity; b. Sell, rent, or lend government equipment or materials to any person or entity for use in independent research and development programs, subject to the condition that the equipment or material be used exclusively for such research and development; c. Make available to any person or entity, at a prescribed fee, the services of any government laboratory, center, or other testing facility for the testing of materials, equipment, models, computer software, and other items; and.1 d. Make available to any person or entity, through leases, contracts, or other appropriate arrangements, facilities, services, and equipment of any government laboratory, research center or range, if the facilities, services, and equipment provided will not be in direct competition with the domestic private sector.

So, What Can You Expect • CRADA Costs – The Government would like to recover: • The actual cost of the scientist, engineer, or technician. • The cost of equipment operation and prorated maintenance • Some portion of the cost of the laboratory’s operation

• TSA – WFO - Commercial Services Agreements – The Government must recover the fully loaded costs of the effort without undue competition with the private sector

• But – expect major change in pricing and flexibility in 10 USC 2539b Test Service Agreements. – Avoidable vs. Full Cost Capture – new competition words

What Happens to Invention and Data Ownership

The Minimums for CRADAs: – GOVERNMENT gets a Government Purpose Non-Exclusive License for all Subject Inventions and Data – PARTNER Gets a Non-Transferable Non-Exclusive License for all Subject Inventions – PARTNER Owns All Subject Data – Gov. gets Gov. Use Rights – Subject Data that Would Be Proprietary Is Protected From FOIA for Five Years, if requested. » Preserves Partner Potential Trade Secret for Five Years

– Small Business can request a 5 year hold on Subject Data hold.

The Minimums for Test Service Agreements – All Subject Inventions and Subject Data belong to the Private Party.

Major Range and Working Capitol - Silent

The Process • Potential Partners Meet with the Technical Staff to Identify Capabilities and Mutual Interest • Parties Develop a Draft SOW • Circulate Draft SOW Through Lab/Center Leadership • Upon Agreement, Parties Refine Costs and SOW • If Agreement Reached, Lab/Center TT Drafts Agreement • Parties Execute Agreement and Begin Work

CRADA Rules For Subject Inventions 1 Here a Blend of Contract and Patent Law Words.

Invention(s) Only by Partner Employee(s) – If Partner Elects to Pay the Cost of Patenting, It Gets All Commercial Rights • Government receives Non-Exclusive for Government Purpose

– If Partner Doesn’t Elect to Pay for Patenting, Government May Do So. (See Next Slide) • Partner Receives a Non-Transferable Non-Exclusive License

CRADA Rules For Subject Inventions 2 Invention Only by Government Employee(s) or Joint Inventions – Government May Elect to Pay the Cost of Patenting • Partner Gets Non-Transferable Non-Exclusive License for All Purposes and an Option for a Limited Term Exclusive License

– If Government Doesn’t Elect to Pay the Costs of Patenting, Partner May Do So (See Rules-1) • Government Gets Non-Exclusive For Government Purposes

• So – Consider – Better a TSA or Working Capitol Fund Agreement if Invention by Government Employee is likely. • No expansion of Gov. Rights in the SBIR IP

TSA Rules For Subject Inventions

Private Partner Gets all Intellectual Property and Data Rights Remember, Industrially Funded and Major Test Range agreements have no IP rights directives. You get what you bargain for.

Questions??? Tim Wittig Principal SAIC Technology Management Advisors [email protected] [email protected] 202 841 0655

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