Contract Number: HHSN261200800001E NCI Control Number: N01-CO-2008-00001 This Page Intentionally Left Blank Contract Number: HHSN261200800001E NCI Control Number: N01-CO-2008-00001 Contents PART I - THE SCHEDULE ............................................................................................. 5 SECTION A - CONTRACT FORM ...................................................................................................... 5 SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS ................................................. 5 ARTICLE B.1. INTRODUCTION AND BRIEF DESCRIPTION OF SUPPLIES OR SERVICES .......................................................................................................................................... 5 ARTICLE B.2. ESTIMATED COST AND AWARD FEE CONSIDERATIONS ....................... 5 ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS ........................................... 9 ARTICLE B.4. ADVANCE UNDERSTANDINGS ....................................................................... 11 ARTICLE B.5. ESTIMATED COST- INCREMENTALLY FUNDED CONTRACT, HHSAR 352.232-71(June 2010) .................................................................................................................. 35 SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT .................................. 35 ARTICLE C.1. STATEMENT OF WORK .................................................................................... 35 ARTICLE C.2. REPORTING REQUIREMENTS ........................................................................ 35 ARTICLE C.3. INVENTION REPORTING REQUIREMENT.................................................... 42 SECTION D - PACKAGING, MARKING AND SHIPPING ............................................................ 43 SECTION E - INSPECTION AND ACCEPTANCE......................................................................... 43 SECTION F - DELIVERIES OR PERFORMANCE......................................................................... 43 ARTICLE F.1. PERIOD OF PERFORMANCE ........................................................................... 43 ARTICLE F.2. LEVEL OF EFFORT............................................................................................. 44 ARTICLE F.3. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY 1998) .......................................................................................................................... 45 SECTION G - CONTRACT ADMINISTRATION DATA ................................................................. 46 ARTICLE G.1. CONTRACTING OFFICER’S REPRESENTATIVE (COR)/ASSISTANT AND ALTERNATE CORs) ............................................................................................................. 46 ARTICLE G.2. KEY PERSONNEL, HHSAR 352.242-70 (Jan 2006) .................................... 47 ARTICLE G.3. PROPERTY ADMINISTRATOR ........................................................................ 47 ARTICLE G.4. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST................... 47 ARTICLE G.5. INDIRECT COST RATES ................................................................................... 49 ARTICLE G.6. GOVERNMENT PROPERTY ............................................................................. 49 ARTICLE G.7. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE ...... 50 ARTICLE G.8. CONTRACTING OFFICER’S REPRESENTATIVE (CORs) FOR INTELLECTUAL PROPERTY ....................................................................................................... 50 Page 1 Contract Number: HHSN261200800001E NCI Control Number: N01-CO-2008-00001 ARTICLE G.9. "AUTHORITY HAVING JURISDICTION", FREDERICK NATIONAL LABORATORY ................................................................................................................................ 50 ARTICLE G.10., ACCOUNTING and APPROPRIATION DATA IDENTIFICATION ON INVOICE SUBMITTAL .................................................................................................................... 51 SECTION H - SPECIAL CONTRACT REQUIREMENTS ............................................................. 51 ARTICLE H.1. AUTHORITIES AND RESPONSIBILITIES OF THE PRINCIPAL PARTIES TO THIS CONTRACT ..................................................................................................................... 51 ARTICLE H.2. CONTINUITY OF SERVICES ............................................................................ 53 ARTICLE H.3. INTERFACE WITH OTHER NCI CAMPUS AT FREDERICK CONTRACTORS AND THE GOVERNMENT ............................................................................. 55 ARTICLE H.4. OPERATIONS AND TECHNICAL SUPPORT RESPONSIBILITY .............. 55 ARTICLE H.5. HUMAN SUBJECTS ........................................................................................... 55 ARTICLE H.6. PRIVACY ACT, HHSAR 352.224-70 (Jan 2006)) ........................................... 56 ARTICLE H.7. HUMAN MATERIALS ......................................................................................... 56 ARTICLE H.8. POLICY AND PROCEDURE (P&P) ................................................................. 56 ARTICLE H.9. OBSERVANCE OF FORT DETRICK REGULATIONS ................................. 56 ARTICLE H.10. UNAUTHORIZED INSTRUCTIONS FROM GOVERNMENT PERSONNEL ............................................................................................................................................................ 56 ARTICLE H.11. CONTRACT IDENTIFICATION ....................................................................... 56 ARTICLE H.12. CONTRACT FEE DESIGNATION .................................................................. 57 ARTICLE H.13. NOVATION AND CHANGE OF NAME AGREEMENTS ............................ 57 ARTICLE H.14. ADVANCE PAYMENT ...................................................................................... 57 ARTICLE H.15. ELECTRONIC AND INFORMATION TECHNOLOGY STANDARDS ...... 61 ARTICLE H.16. TECHNOLOGY TRANSFER ........................................................................... 61 ARTICLE H.17. ANIMAL CARE PROCEDURES ..................................................................... 68 ARTICLE H.18. INTRODUCTION OF RODENTS AND RODENT PRODUCTS ................. 68 ARTICLE H.19. DISPOSITION OF ANIMALS AT FNLCR ...................................................... 68 ARTICLE H.20. ANIMAL WELFARE .......................................................................................... 69 ARTICLE H.21. RESEARCH INVOLVING RECOMBINANT DNA MOLECULES .............. 69 ARTICLE H.22. SAFETY STANDARDS..................................................................................... 69 ARTICLE H.23. CONSULTANT OR OTHER COMPARABLE EMPLOYMENT SERVICES OF CONTRACTOR EMPLOYEES ................................................................................................ 69 ARTICLE H.24. COMMITTEE RESPONSIBILITIES ................................................................. 69 ARTICLE H.25. SCIENTIFIC COLLABORATION .................................................................... 70 Page 2 Contract Number: HHSN261200800001E NCI Control Number: N01-CO-2008-00001 ARTICLE H.26. CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH .. 70 ARTICLE H.27. NEEDLE DISTRIBUTION ................................................................................. 70 ARTICLE H.28. OMB CLEARANCE ........................................................................................... 70 ARTICLE H.29. SUBCONTRACTING PROVISIONS ............................................................... 71 ARTICLE H.30. SUBCONTRACTING ........................................................................................ 71 ARTICLE H.31. Reserved.............................................................................................................. 72 ARTICLE H.32. INFORMATION SECURITY .............................................................................. 72 ARTICLE H.33. RESERVED ........................................................................................................ 75 ARTICLE H.34. PUBLICATION AND PUBLICITY ................................................................... 75 ARTICLE H.35. PRESS RELEASES .......................................................................................... 75 ARTICLE H.36. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE .... 76 ARTICLE H.37. LIMITATION ON USE OF FUNDS FOR PROMOTION OF LEGALIZATION OF CONTROLLED SUBSTANCES ............................................................... 76 ARTICLE H.38. ORGANIZATIONAL CONFLICTS OF INTERESTS .................................... 76 ARTICLE H.39. RESERVED ........................................................................................................ 78 ARTICLE H.40. PERFORMANCE-BASED AWARD FEE PLAN ............................................ 78 ARTICLE H.41. HOTEL AND MOTEL FIRE SAFETY ACT OF 1990 (P.L. 101-391) ........ 78 ARTICLE H.42. POSSESSION, USE AND TRANSFER OF SELECT BIOLOGICAL AGENTS OR TOXINS ..................................................................................................................... 79 ARTICLE H.43. ACCESS TO NATIONAL INSTITUTES OF HEALTH (NIH) ELECTRONIC MAIL ................................................................................................................................................... 79 ARTICLE H.44. NIH POLICY ON ENHANCING PUBLIC ACCESS TO ARCHIVED PUBLICATIONS RESULTING FROM NIH-FUNDED RESEARCH ........................................ 79 ARTICLE H.45. EXCEPTION