Contracting at a Federally Funded Research and Development Center (FFRDC)

1. Contracting at a Federally Funded Research and Development Center (FFRDC) John TrifoneDirector, Contracts & Acquisitions Leidos Biomedical Research, Inc. January 30, 2014

2. Discussion Points • Defining an FFRDC • What is an FFRDC • Key FFRDC Characteristics • How does an FFRDC meet the needs of the Nation? • Overview of the FNLCR FFRDC • How does the FNLCR FFRDC differ from other FFRDC’s • FNLCR Use of Cooperative Research and Development Agreements (CRADA) • Subcontracting environment at an FFRDC • Who does the FFRDC subcontract for • What challenges does this provide

3. Overview of a Federally Funded Research and Development Center Federally Funded Research and Development Centers (FFRDC) means activities that are sponsored under a broad charter by a Government Agency (or agencies) for the purpose of performing, analyzing, integrating, supporting, and/or managing basic or applied research and/or development, and that receive 70% or more of their financial support from the Government. (excerpted from FAR 2.101)

4. Key FFRDC Characteristics • A long-term Government/contractor relationship is contemplated. • Most or all of the facilities are owned or funded by the Government. • The contractor has access to Government data, employees, and facilities beyond that common in a typical contractual relationship. • Operates in the public interest with objectivity and free of organizational conflicts of interest.

5. Key FFRDC Characteristics (Cont’d) • The FFRDC may perform work for other than the sponsoring agency under the Economy Act or other applicable legislation. • The FFRDC status requires the contractor to meet the sponsor’s rapidly changing needs by attaining a level of flexibility, creativity, and responsiveness that cannot be achieved as effectively by other government components or through other Government mechanisms. • FFRDC’s are operated, managed, and /or administered by either a university or consortium of universities, other not-for-profit or non profit organizations, or an industrial firm, as an autonomous organization or as an identifiable separate operating unit of a parent organization.

6. Key FFRDC Characteristics (Cont’d) The FFRDC provides the Sponsor a unique structure which facilitates: • Flexibility– the FFRDC provides for broad latitude in how the work is performed (in-house vs. subcontracts). • Rapid Response - new or cutting-edge projects can be accomplished more expeditiously because of the FFRDC broad charter and access to Government personnel. • Increased Efficiency– the FFRDC maintains a staff of highly trained professionals. New work can be added without incurring additional indirect costs; infrastructure costs; or fees for contract administration, management and oversight. • Accountability– FFRDC is generally a performance-based contract (i.e. contactor profit is tied directly to performance).

7. FFRDC Restrictions • FAR 35.017-1(c)(4): Prohibits the FFRDC from competing with any non-FFRDC concern in response to a federal agency request for proposal • FAR 35.017(a)(2): The FFRDC must operate in the public interest with objectivity and independence and free of any organizational conflict of interest

8. How can the FFRDC more effectively serve the needs of academic, industry, and the Small Business Community? • Improve access to the advanced technologies, including; • Genomics and next generation sequencing • Protein chemistry and proteomics • Imaging (molecular, cellular and small animal) • Improve access to clinical trials resources, including; • Biopharmaceutical development/production • Nanotechnology characterization • Standardized clinical assays • Develop a national training program in advanced technologies, biopharmaceuticals and clinical assays • Provide a more robust beta-test program for the development of new technologies • Facilitate the use of public-private partnerships to expedite the development of novel agents for the prevention, diagnosis and treatment of cancer and AIDS

9. Examples of How the FNLCR FFRDC is Meeting the Needs of the Nation • Nanotechnology Characterization Laboratory (NCL) • Biopharmaceutical Development Program (BDP) • Advanced Biomedical Computing Center (ABCC) • Vaccine Clinical Materials Program (VCMP) • National Community Cancer Centers Program (NCCCP) • NCI/NIGMS Beamline Project • NCI Biospecimen Resources Network (BRN) • Mouse Models of Human Cancer Consortium (MMHCC) • Cancer Bioinformatics Grid (caBIG) • The Cancer Genome Atlas Project (TCGA) • Therapeutically Applicable Research to Generate Effective Treatments (TARGET)

10. Other Examples of How the Frederick National Laboratory for Cancer Research is Meeting the Needs of the Nation • Provided basic and clinical research services to 25 of the 27 NIH ICs • Provided advanced technology expertise and support to the DHS, DoD, FDA and USDA • Executed more than 3,900 material transfer agreements and 30 collaborative research agreements with numerous universities and industry collaborators • Filed more than 50% of NCI’s invention reports • Produced over 60 novel biopharmaceutical products and vaccines through two cGMP manufacturing programs • Supported over 350 NCI and NIAID-sponsored clinical trials to test innovative cancer and AIDS treatments • Acquired over 1.5 million clinical samples and stored over 2 terabytes of patient data in support of cancer and AIDS clinical trials worldwide • Provided advanced biomedical computing expertise and support every year to >1,800 users as one of the world’s largest computer resources dedicated to biomedical research

11. Overview of Frederick NationalLaboratory for Cancer Research • FNLCR is the Federally Funded Research and Development Center • Established in 1972 • Only FFRDC dedicated to biomedical research • Proudly operated by Leidos Biomedical Research, Inc. (formerly SAIC-Frederick, Inc.) on behalf of the National Cancer Institute • Main campus on 70 acres at Fort Detrick • Co-located with intramural NCI researchers and other NCI activities • The FFRDC Contractor maintains several offsite locations including the Advanced Technology Research Facility (ATRF) off Gas House Pike (~300,000 sqft research facility) and the Vaccine Pilot Plant (located off of Rt 85)

12. Mission: Provide a unique national resource for the development of new technologies and the translation of basic science discoveries into novel agents for the prevention, diagnosis and treatment of cancer and AIDS. Overview of Frederick NationalLaboratory for Cancer Research

13. The FNLCR - A Unique National Resource Meeting the most urgent biomedical research needs of the nation, including: • The NCI • Other NIH institutes • Other government agencies • Extramural investigators • NCI corporate partners

14. Fundamental differences between DOE FFRDC’s and the FNLCR FFRDC • DOE Laboratories and academia provide the science for all DOE’s needs • The NIH and NCI have robust intramural science programs • DOE Laboratories compete with each other for much of their funding • As the only NIH FFRDC for biomedical research, FNLCR does not directly compete with other National Laboratories for NIH funding • Many DOE Laboratories offer “Facility Use Agreements” which is functionally unique, sustainably funded and draws users from the external research community to the National Laboratory • FNLCR has no comparable facility use program • DOE Laboratories have access to Congressionally-mandated Lab-directed Research and Development funds (LDRD) via a 3% to 6% “tax” on all expenditures • No formal “LDRD” at FNLCR (refer to cCRADA program noted later in this presentation) • DOE has received statutory authority to conduct a “Work for Others” program that allows for extensive collaboration with outside sources (non-federal) and receipt of funds to cover cost for performance of services • NCI does not have the requisite authority but the FFRDC does have CRADA (Cooperative Research and Development Agreement) authority.

15. Some examples of how DOE FFRDC Laboratories operate • Lawrence Berkley National Laboratory (University of California –Berkley) • $124M in “Work for Others” • Supercomputer, Molecular Foundry, Bioenergy • Access is free if you publish, otherwise cost recovery • 15,000+ scientific visitors per year • Lawrence Livermore National Laboratory (Joint LLC Bechtel/Univ. of California) • High performance computing and laser (500 terawatts) facility are main draw for external resources • Extensive use of: • cCRADA (Contractor Cooperative Research and Development Agreement) • Work for Others • Advancing Commercial Technology (ACT) • Contracts with partner directly and accepts liability and risk for delivery; no government involvement or reach-in • Licenses technology to enable startups • Sandia National Laboratory (Sandia Corporation – wholly owned subsidiary of Lockheed Martin) • Core missions – ensure nuclear weapon stockpile is safe, secure, and reliable • Operates Combustion Laboratory, which provides sustained funding • Highly entrepreneurial

16. Federal Technology Transfer Background • Federal national laboratories exist to: • Foster technology development and technology transfer to private sector • Promote knowledge and resource sharing • Advance national competitiveness • Laws and policies enacted supporting federal technology transfer (examples): • Federal Technology Transfer Act (1986) • All federal laboratory scientists required to consider TT an individual responsibility • Executive Order 12591 (1987) • Ensure that federal laboratories assist universities and private sector by transferring technical knowledge…establish industrial extension services… • National Competitiveness Technology Transfer Act (1989) • Extends CRADA authority to government-owned, contractor-operated (GOCO) laboratories

17. Expanding the Partner Base at the FNLCR through Contractor Cooperative Research and Development Agreement (cCRADA) A Cooperative Research and Development Agreement (CRADA) is a type of agreement that enables industry, academia and other nonprofit entities to collaborate with the federal government and/or the federal laboratory in mutually beneficial joint research and development activities. Although NCI researchers at FNLCR have been able work with outside entities under a NIH CRADA, Leidos Biomedical Researchers working at FNLCR have been unable to do so without the participation of an NCI researcher as lead investigator or in direct support of NCI research. The approval to allow Leidos Biomedical Researchers to enter into CRADAs (Contractor CRADA or cCRADA) without NCI participation in the research is a unique opportunity for Leidos Biomedical researchers to become engineers in the innovation process by expanding collaborative opportunities and enhancing the existing technology portfolio.

18. Contractor CRADAs:Accelerates Fed Lab Model, Adds Flexibility • Benchmark: NCI (Government) CRADAs—key elements as a business mechanism • Partner receives advanced promise to Intellectual Property (IP) resulting from CRADA work • However, terms cannot be pre-negotiated • $$ can flow into NCI for CRADA work • Contractor CRADA authority offers key advantages: • Leidos Biomedical Research can establish CRADAs with partners directly (no NCI investigator involved) • Partner receives advanced promise to IP resulting from CRADA work • Leidos Biomedical Research can pre-negotiate IP terms with partner (private sector +++) • $$ can flow directly into Leidos Biomedical for CRADA work • TSAs (simplified Materials-CRADA) enable extramural access to unique services • Local (FNL) agreement processes will speed-up administrative approvals

19. Contractor CRADAs:Accelerates Fed Lab Model, Adds Flexibility • Enables Leidos Biomedical Research to partner directly with extramural scientists and organizations for access to our science and technology know-how • Use full CRADA authority under CRADA statutes • c-CRADAs for Research, Development, and Testing collaborations • “Technical Service Agreement” for tactical evaluation of proprietary partner materials, AIDS testing kits, etc. • Intellectual property rights • Leidos Biomedical is the custodian of joint or sole IP emerging from the CRADA •  Streamlined assignment of exclusive commercialization rights •   Any royalty streams support FFRDC R&D efforts • Processes •  Focus on speed •  Local government review and approval with external input as appropriate

20. Contractor CRADAs • Technical Service Agreement (TSA) • Pre-approved service • Requires • Cost Estimate • Signed Agreement by the Outside Party and Dr. Heimbrook • Receipt of Funds Prior to Beginning Work • CRADA • Requires • Completion of a Concept Approval Form for review by the Strategic Business Development Team (SBDT) • Approval by the NCI Program • Approval by the NCI Management Operations and Support Branch (MOSB) • Receipt of Funds (Milestone Payment) Prior to Beginning Work

21. Accelerating progress against Cancer and AIDS FNLCR Collaborators Private Sector Public Sector • Federal, state, and local government • Academia/Grantees • Technology incubators • Pharmaceutical firms • Top-tier biotech and IT firms • SBIR/STTR recipients • Equipment and device manufacturers FNLCRFFRDCPartnerships

22. Accelerating progress against Cancer and AIDS …integrated into a brandnew state-of-the-artResearch Facility We have essentialcapabilities… Genetics and Genomics Proteins and Proteomics Integrated in vivo Services Imaging and Nanotechnology Advanced Biomedical Computing Advanced Technology Research Facility Opened June 2012

23. Subcontracting Environment at the FNLCR FFRDC • The FFRDC Contractor supports the entire facility (GOCO) to include infrastructure support, laboratory operations and maintenance, supply chain operations, security, operation of onsite Occupational Health clinic, etc. • These functional responsibilities include those for other onsite contractors as well as the on site Government employees • Subcontracting/outsourcing plays a large role in the day to day operations of the facility • Requires: • Quick reaction • Reasonable Cost solutions • Timely delivery of products and services

24. What does an FFRDC Subcontract for? • Commercial goods/services (primarily FAR Part 12/13) • Laboratory equipment and supplies • Biomedical materials • Animals and animal supplies • Testing services • Maintenance and repair services • Motor vehicles • Furniture (office and laboratory) • Office supplies/general administrative supplies • Cleaning/Janitorial supplies

25. What does an FFRDC Subcontract for? • Research and development services and subcontracts (primarily FAR Part 15) • Vaccine development, pharmaceutical development and manufacturing,R&D services (cGMP) • IT support services • Biomedical research services • Tissue specimens, cell production services, and DNA sequencing • Consultant services (scientific and administrative) • Construction services (FAR Part 36) • General contractor services for new construction and renovation activities (all trades) • Architect and engineering services • Demolition services

26. What challenges arise for FFRDC Subcontracts? • FAR 35.017 (a)(2) states (in part) “An FFRDC...has access, beyond that which is common to the normal contractual relationship, to Government and supplier data, including sensitive and proprietary data..” • While the FFRDC contractor is responsible for conducting the acquisitions, the Government may play a large role in the development and ongoing performance of subsequent awards • With respect to the NCI FFRDC Contract, Leidos Biomedical Research operates under a Determination of Exceptional Circumstances (DEC) from the Bayh-Dole Act which requires all Intellectual Property “conceived or first reduced to practice” to be assigned to the NCI unless performed under subcontract by a small business or academic institution.

27. What challenges arise for FFRDC Subcontracts? (Cont’d) • Many laboratories require product consistency during unique research experiments which requires specific vendor/products be provided • Approval of final subcontract deliverables may not rest solely on the contractor but with the Government as well • On site construction/renovation does not follow city/county codes • Does fall within the NIH Design Requirements Manual • Defines detailed design requirements and guidance manual for biomedical research laboratory and animal research facilities • Subcontractor design and construction will be required to fall within these guidelines unless otherwise waived by the Government

28. What challenges arise for FFRDC Subcontracts? (Cont’d) • Prime contract requires background checks on subcontractor employees • The FFRDC Prime Contract does include a Small Business Subcontracting Plan • Currently exceeding goal for small business overall • Challenges include sourcing within the HubZone, Veteran Owned and Service Disabled Veteran Owned Businesses • Firms in certain socio-economic categories unable to provide the unique products or services needed at the FFRDC • Competing with other small business firms or large businesses that have acquired distributorships

29. What challenges arise for FFRDC Subcontracts? (Cont’d) • Require quick reaction to proposal requests • Competitive pricing and delivery • Innovative ideas/solutions • ETHICS ARE PARAMOUNT

30. Conclusion • FFRDC Contracts are not your standard prime contracts • Autonomy and Free from Conflicts of Interest • Contracts not to be viewed as a regular P&L contract but rather solving a needed mission of the Government • Provide access to the scientific/technology community to national resources QUESTIONS?