(10) Government Contracts

 

                          (10)   Government Contracts

                          (10)   Government Contracts

               1.    Biological Testing Facility.

DHHS ###-##-#### OMB NO. 0990-0115 ==================================================================================================================================== AWARD/CONTRACT 1. THIS CONTRACT IS RATED ORDER RATING PAGE OF PAGES UNDER DPAS (15 CFR 350) 1 60 - - ------------------------------------------------------------------------------------------------------------------------------------ 2. CONTRACT NO. (Proc. Inst. Indent.) 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQUEST/PROJECT NO. NO1-HD-6-3259 09/01/96 96-3259-00 - - ------------------------------------------------------------------------------------------------------------------------------------ 5. ISSUED BY CODE 6. ADMINISTERED BY (if other than Item 5) CODE ------------------------ ----------------- Contracts Management Branch, NICHD National Institutes of Health, PHS, DHHS COPY Executive Building, Suite 7A07 6100 EXECUTIVE BLVD MSC 7510 BETHESDA MD 20892-7510 - - ------------------------------------------------------------------------------------------------------------------------------------ 7. NAME AND ADDRESS OF CONTRACTOR (No., street, city, county, State and ZIP Code) 8. DELIVERY BIOQUAL, Inc. / / FOB ORIGIN /X/ OTHER (See below) 9600 Medical Center Drive Rockville, MD 20850 ------------------------------------------------ 9. DISCOUNT FOR PROMPT PAYMENT ------------------------------------------------ 10. SUBMIT INVOICES ITEM (4 copies unless otherwise See Section G.4 specified) - - ----------------------------------------------------------------------------------- CODE FACILITY CODE TO THE ADDRESS SHOWN IN: - - ------------------------------------------------------------------------------------------------------------------------------------ 11. SHIP TO/MARK FOR CODE 12. PAYMENT WILL BE MADE BY CODE ------------------------ ----------------- See Section J. Attachment J.1.b See Section G.4 F.O.B. Destination - - ------------------------------------------------------------------------------------------------------------------------------------ 13. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION 14. ACCOUNTING AND APPROPRIATION DATA N/A CAN: 6-8420946 ($2,793,568) O.C. 25.55 / / 10 U.S.C. 2304(c)( ) / / 41 U.S.C. 253(c)( ) DOC: 300NIHD63259A TIN: 1-521244771-A1 - - ------------------------------------------------------------------------------------------------------------------------------------ 15A. ITEM NO. 15B. SUPPLIES/SERVICES 15C. QUANTITY 15D. UNIT 15E. UNIT PRICE 15F. AMOUNT - - ------------------------------------------------------------------------------------------------------------------------------------ Title: "Biological Testing Facility" Incremental Funding ----------- -------------- Principal Investigator: Jerry R. Reel, Ph.D. FY 96 $ 2,793,568.00 FY 97 2,897,666.00 Contract Type: Cost-Plus-Fixed-Fee (Term) FY 98 3,004,999.00 FY 99 3,107,788.00 Expiration Date: June 30, 2001 FY 00 3,211,870.00 - - ------------------------------------------------------------------------------------------------------------------------------------ 15G. TOTAL AMOUNT OF CONTRACT -} $15,015,891.00 - - ------------------------------------------------------------------------------------------------------------------------------------ 16. TABLE OF CONTENTS - - ------------------------------------------------------------------------------------------------------------------------------------ (X) SEC. DESCRIPTION PAGE(S) (X) SEC. DESCRIPTION PAGE(S) - - ------------------------------------------------------------------------------------------------------------------------------------ PART I - THE SCHEDULE PART II - CONTRACT CLAUSES - - ------------------------------------------------------------------------------------------------------------------------------------ X A SOLICITATION/CONTRACT FORM X I CONTRACT CLAUSES - - ------------------------------------------------------------------------------------------------------------------------------------ X B SUPPLIES OR SERVICES AND PRICES/COSTS PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH. - - ------------------------------------------------------------------------------------------------------------------------------------ X C DESCRIPTIONS/SPECS./WORK STATEMENT X J LIST OF ATTACHMENTS - - ------------------------------------------------------------------------------------------------------------------------------------ X D PACKAGING AND MARKING PART IV - REPRESENTATIONS AND INSTRUCTIONS - - ------------------------------------------------------------------------------------------------------------------------------------ X E INSPECTION AND ACCEPTANCE X K REPRESENTATIONS, CERTIFICATIONS AND - - ------------------------------------------------------------------- OTHER STATEMENTS OF OFFERORS X F DELIVERIES OR PERFORMANCE - - ------------------------------------------------------------------------------------------------------------------------------------ X G CONTRACT ADMINISTRATION DATA N/A L INSTRS., CONDS., AND NOTICES TO OFFER - - ------------------------------------------------------------------------------------------------------------------------------------ X H SPECIAL CONTRACT REQUIREMENTS N/A M EVALUATION FACTORS FOR AWARD - - ------------------------------------------------------------------------------------------------------------------------------------ CONTRACTING OFFICER WILL COMPLETE ITEM 17 OR 18 AS APPLICABLE - - ------------------------------------------------------------------------------------------------------------------------------------ 17. /X/ CONTRACTOR'S NEGOTIATED AGREEMENT (Contractor is required 18. / / AWARD (Contractor is not required to sign this to sign this document and return 1 copies to issuing office.) document.) Your offer on Solicitation Number ___, including Contractor agrees to furnish and deliver all items or perform all the additions or changes made by you which additions or the services set forth or otherwise identified above and on any changes are set forth in full above, is hereby accepted as to continuation sheets for the consideration stated herein. The the items listed above and on any continuation sheets. This rights and obligations of the parties to this contract shall be award consummates the contract which consists of the subject to and governed by the following documents: (a) this following documents: (a) the Government's solicitation and award/contract, (b) the solicitation, if any, and (c) such your offer, and (b) this award/contract. No further provisions, representations, certifications, and specifications, contractual document is necessary. as are attached or incorporated by reference herein. (Attachments are listed herein.) - - ------------------------------------------------------------------------------------------------------------------------------------ 19A. NAME AND TITLE OF SIGNER (Type or print) 20A. NAME OF CONTRACTING OFFICER Paul J. Duska [name] Contracts Management Branch, OAM, NICHD - - ------------------------------------------------------------------------------------------------------------------------------------ 19B. NAME OF CONTRACTOR 19C. DATE SIGNED 20B. UNITED STATES OF AMERICA 20C. DATE SIGNED BY [sig] 8/8/96 BY /s/ PAUL J. DUSKA 8/12/96 ------------------------------------------- ------------------------------------------- (Signature of person authorized to sign) (Signature of Contract Officer) ==================================================================================================================================== STANDARD FORM 26 REV (4-85)
TABLE OF CONTENTS PAGE PART I - THE SCHEDULE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1 SECTION A - SOLICITATION/CONTRACT FORM . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1 SF 26 AWARD/CONTRACT Page 1 of Pages . . . . . . . . . . . . . . . . . . . . . . . A-1 SECTION B - SUPPLIES OR SERVICES AND PRICE/COSTS . . . . . . . . . . . . . . . . . . . . . . . B-1 B.1 BRIEF DESCRIPTION OF SERVICES . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1 B.2 HHSAR 352.232-74 CONSIDERATION - ESTIMATED COST AND FIXED FEE . . . . . . . . . . B-1 (APR 1984) B.3 ADVANCE UNDERSTANDINGS (NIH 1240) (JUL 1986) . . . . . . . . . . . . . . . . . . B-1 B.4 LIMITATION OF FUNDS--COST-PLUS-FIXED-FEE/COST-PLUS- . . . . . . . . . . . . . . . . B-2 INCENTIVE-FEE (NIH 1255) (NOV 1988) B.5 CLAUSES APPLICABLE TO DIRECT COSTS . . . . . . . . . . . . . . . . . . . . . . . . B-2 (NIH 2990A) (JUN 1989) B.6 PRE-CONTRACT COSTS (NIH 3000) (JUL 1986) . . . . . . . . . . . . . . . . . . . . B-3 B.7 FEE TIED TO LEVEL OF EFFORT (NIH 3005) (JUL 1986) . . . . . . . . . . . . . . . . B-3 B.8 GOVERNMENT DISCOUNT AIR TRAVEL RATES (NIH 3161) (MAY 1989) . . . . . . . . . . . B-4 B.9 INCREMENTAL FUNDING ALLOCATION ALTERNATE I . . . . . . . . . . . . . . . . . . . . B-4 (NIH 3175) (AUG 1988) SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT . . . . . . . . . . . . . . . . . . . . . C-1 C.1 WORK STATEMENT/SPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . C-1 (NIH 1040B) (JUL 1986) SECTION D - PACKAGING AND MARKING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-1 [For this Contract, there are NO clauses in this Section] . . . . . . . . . . . . . . . . D-1 SECTION E - INSPECTION AND ACCEPTANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-1 E.1 NOTICE LISTING CONTRACT CLAUSES INCORPORATED BY REFERENCE . . . . . . . . . . . . . E-1 E.2 INSPECTION AND ACCEPTANCE (NIH 3045) (MAY 1989) . . . . . . . . . . . . . . . . . E-1 SECTION F - DELIVERIES OR PERFORMANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F-1 F.1 NOTICE LISTING CONTRACT CLAUSES INCORPORATED BY REFERENCE . . . . . . . . . . . . . F-1 F.2 PERIOD OF PERFORMANCE (NIH 1060) (MAY 1989) . . . . . . . . . . . . . . . . . . . F-1 F.3 LEVEL OF EFFORT---COST-REIMBURSEMENT TERM CONTRACT . . . . . . . . . . . . . . . . F-1 (NIH 1050) (NOV 1988) F.4 VARIATIONS IN PERFORMANCE--TOTAL EFFORT . . . . . . . . . . . . . . . . . . . . . . F-2 (NIH 3030) (JUL 1986) F.5 REPORTING REQUIREMENTS (NIH 3055B) (MAR 1988) . . . . . . . . . . . . . . . . . . F-2 SECTION S - CONTRACT ADMINISTRATION DATA . . . . . . . . . . . . . . . . . . . . . . . . . . . G-1 G.1 KEY PERSONNEL (NIH 3060) (JUL 1986) . . . . . . . . . . . . . . . . . . . . . . . G-1 G.2 PROJECT OFFICER (NIH 1900) (NOV 1988) . . . . . . . . . . . . . . . . . . . . . . G-1 G.3 INDIRECT COST RATES (NIH 1295) (JUL 1986) . . . . . . . . . . . . . . . . . . . . G-2 G.4 INVOICE SUBMISSION (NIH RC-1A) (DEC 1988) ALTERNATE I . . . . . . . . . . . . . . G-2 G.5 CONTRACT FINANCIAL REPORT (NIH 2706) (APR 1992) . . . . . . . . . . . . . . . . . G-3 G.6 GOVERNMENT PROPERTY (NIH 3065) (JUL 1986) . . . . . . . . . . . . . . . . . . . . G-3 G.7 GOVERNMENT FURNISHED PROPERTY - SCHEDULE II-A . . . . . . . . . . . . . . . . . . . G-4 NIH 3065c) (JUL 1986) SECTION H - SPECIAL CONTRACT REQUIREMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . H-1 H.1 HHSAR 352.270-6 PUBLICATIONS AND PUBLICITY (JUL 1991) . . . . . . . . . . . . . . H-1 H.2 PHS 352.223-70 SAFETY AND HEALTH (APR 1984) . . . . . . . . . . . . . . . . . . . H-1 H.3 HUMAN SUBJECTS (NIH 3085) (JUL 1986) . . . . . . . . . . . . . . . . . . . . . . H-2
TABLE OF CONTENTS PAGE H.4 SALARY RATE LIMITATIONS LEGISLATION (NIH 3102) (OCT 1993). . . . . . . . . . . . . H-2 H.5 ANIMAL WELFARE ASSURANCE (NIH 3200) (JUN 1993) . . . . . . . . . . . . . . . . . . H-3 H.6 ACKNOWLEDGEMENT OF SUPPORT (NIH 3480)(FEB 1992) . . . . . . . . . . . . . . . . . H-3 PART II - CONTRACT CLAUSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I-1 SECTION I - CONTRACT CLAUSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I-1 I.1 CONTRACT CLAUSES (NIH 3105B) (MAR 1988) . . . . . . . . . . . . . . . . . . . . . I-1 I.2 CLAUSES INCORPORATED IN FULL TEXT (NIH 3110) (JUL 1986) . . . . . . . . . . . . . I-1 I.3 NOTICE LISTING CONTRACT CLAUSES INCORPORATED BY REFERENCE . . . . . . . . . . . . . I-1 I.4 52.203-9 REQUIREMENT FOR CERTIFICATE OF PROCUREMENT . . . . . . . . . . . . . . . I-3 INTEGRITY-MODIFICATION (SEP 1995) I.5 52.222-2 PAYMENT FOR OVERTIME PREMIUMS (JUL 1990) . . . . . . . . . . . . . . . . I-5 I.6 52.252-2 CLAUSES INCORPORATED BY REFERENCE (JUN 1988) . . . . . . . . . . . . . . I-6 PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS . . . . . . . . . . . . . . . . J-1 SECTION J - LIST OF ATTACHMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . J-1 J.1 LIST OF ATTACHMENTS (NIH 1365) (JUL 1986) . . . . . . . . . . . . . . . . . . . . J-1 PART IV - REPRESENTATIONS AND INSTRUCTIONS . . . . . . . . . . . . . . . . . . . . . . . . . K-1 SECTION K - REPRESENTATIONS, CERTIFICATIONS AND . . . . . . . . . . . . . . . . . . . . . K-1 OTHER STATEMENTS OF OFFERORS K.1 REPRESENTATIONS AND CERTIFICATIONS (NIH 3115) (JUN 1986) . . . . . . . . . . . . . K-1
NO1-HD-6-3259 Section B PART I - THE SCHEDULE SECTION B - SUPPLIES OR SERVICES AND PRICE/COSTS B.1 BRIEF DESCRIPTION OF SERVICES The major objective of this project is to provide for the operation and maintenance of a biological testing facility. B.2 HHSAR 352.232-74 CONSIDERATION - ESTIMATED COST AND FIXED FEE (APR 1984) It is estimated that the total cost to the Government for full performance of this contract will be $15,015,891.00, of which the sum of $14,164,742.00 represents the estimated reimbursable costs and $851,149.00 represents the fixed-fee. B.3 ADVANCE UNDERSTANDINGS (NIH 1240) (JUL 1986) Other clauses of this contract notwithstanding, approval of the following items within the limits set forth is hereby granted: a. Consultant fee to be paid to the following individual for pathology services: Total Cost Name Rate Number of Hours Not to Exceed Dr. F. M. Garner $73/Hr* 64 $5,000 *Escalated at 4% per year for years 2 through 5. b. Clinical chemistry services in a total amount not to exceed $15,000 for the period stated in Section F. c. Pathology services in a total amount not to exceed $45,000 for the period stated in Section F. d. The contractor has agreed that the following individuals will be assigned to this contract at 100% effort: Principal Investigator Manager, Bioassay Manager, Immunoassay Bioassay Technicians (5) Immunoassay Technicians (3) e. A subcontract document and negotiated cost for toxicology studies shall be submitted to the Contracting Officer for approval B-1 NO1-HD-6-3259 Section B prior to award. B.4 LIMITATION OF FUNDS--COST-PLUS-FIXED-FEE/COST-PLUS- INCENTIVE-FEE (NIH 1255) (NOV 1988) (a) Total funds currently available for payments and allotted to this contract are $2,793,568.00, of which $2,636,131.00 represents the estimated costs, and of which $157,437.00 represents the fixed fee. For further provisions on funding, see the LIMITATION OF FUNDS clause referenced in SECTION I of this contract. (b) It is estimated that the amount currently alloted will cover performance of the contract through June 30, 1997. (c) The contracting officer may allow additional funds to the contract without the concurrence of the contractor. B.5 CLAUSES APPLICABLE TO DIRECT COSTS (NIH 2990A) (JUN 1989) (a) Items Unallowable Unless Otherwise Provided Notwithstanding the Clause ALLOWABLE COST AND PAYMENT (and FIXED FEE, if applicable) referenced in SECTION I of this contract, unless authorized in writing by the Contracting Officer, the costs of the following items or activities shall be unallowable as direct costs: (1) Acquisition, by purchase or lease, of any interest in real property; (2) Special rearrangement or alteration of facilities; (3) Purchase or lease of ANY item of general purpose office furniture or office equipment regardless of dollar value (General purpose equipment is defined as any items of personal property which are usable for purposes other than research, such as office equipment and furnishings, pocket calculators, etc.); and (4) Travel to attend general scientific meetings; (5) Patient care costs; (6) Accountable Government property (defined as both real and personal property with an acquisiton cost of $1,000 or more and a life expectancy of more than two years) and "sensitive items" (defined and listed in the CONTRACTOR'S GUIDE FOR CONTROL OF GOVERNMENT PROPERTY, 1990) regardless of acquisition value. (b) Travel Costs (1) Domestic Travel a. Total expenditures for domestic travel (transportation, lodging, subsistence, and incidental expenses) incurred in direct B-2 NO1-HD-6-3259 Section B performance of this contract shall not exceed $.00 without the prior written approval of the Contracting Officer. b. This contract is subject to the provisions of Section 24 of Public Law 99-234 which amends the Office of Federal Procurement Policy Act to provide that contractor costs for travel, including lodging, other subsistence, and incidental expenses, shall be allowable only to the extent that they do not exceed the amount allowed Federal employees. The contractor, therefore, shall invoice and be reimbursed for all travel costs in accordance with Federal Acquisition Regulations (FAR) 31.205-46. (2) Foreign Travel Requests for foreign travel must be submitted at least six weeks in advance, and shall contain the following: a. Meeting(s) and place(s) to be visited, with costs and dates; b. Names and titles of contractor personnel to travel, their functions in the contract project; c. Contract purposes to be served by the travel; d. How travel of contractor personnel will benefit and contribute to accomplishing the contract project, or will otherwise justify the expenditure of NIH contract funds; e. How such advantages justify the costs for travel and absence from the project of more than one person if such are suggested; and f. What additional functions may be performed by the travelers to accomplish other purposes of the contract and thus further benefit the project. B.6 PRE-CONTRACT COSTS (NIH 3000) (JUL 1986) Within the dollar limitation set forth under this SECTION B, below, the Contractor shall be entitled to reimbursement for costs incurred during the period July 1, 1996 through August 31, 1996 in an amount not to exceed $465,595.00, which if incurred after this contract had been entered into, would have been reimbursable under the provisions of this contract. B.7 FEE TIED TO LEVEL OF EFFORT (NIH 3005) (JUL 1986) The fixed fee shall be paid in direct ratio to the level of effort expended; that is, the percent of fee paid shall be equal to the percent of total effort expended. Payment shall be subject to the withholding provisions of the Clauses ALLOWABLE COST AND PAYMENT, and FIXED FEE referenced in SECTION I of this contract. Payment of B-3 NO1-HD-6-3259 Section B fixed fee shall not be made in less than monthly increments. B.8 GOVERNMENT DISCOUNT AIR TRAVEL RATES (NIH 3161) (MAY 1989) (a) To the maximum extent practicable consistent with travel requirements, the contractor agrees to use the reduced air transportation rates and services provided through available government discount air fares. These fares are available only for bona-fide employees' travel that is otherwise reimbursable as a direct cost pursuant to this contract. The objective is to achieve the lowest overall cost to the contractor and, thus, to the Government. The contractor shall submit written requests to the contracting officer for authorization to use these rates. The request shall provide the full name of the traveler(s), the number of the contract for which the travel is being performed, the contract objective that is to be fulfilled, and the dates during which the travel is to occur. Contracting officer approval, if given, will be on official agency letterhead so that the letter can be presented to the airlines as confirmation of the authorization. (b) Nothing in this clause shall authorize transportation or services which are not otherwise reimbursable under this contract. Nothing in this clause requires air carriers to make available to the contractor any government discount air fares. B.9 INCREMENTAL FUNDING ALLOCATION ALTERNATE I (NIH 3175) (AUG 1988) Increments to be allotted to this contract are estimated as follows:
PERIOD COST FIXED FEE AMOUNT FY96 7/01/96 6/30/97 $ 2,636,131 $ 157,437 $ 2,793,568 FY97 7/01/97 - 6/30/98 2,733,876 163,790 2,897,666 FY98 7/01/98 - 6/30/99 2,834,658 170,341 3,004,999 FY99 7/01/99 - 6/30/00 2,931,174 176,614 3,107,788 FY00 7/01/00 - 6/30/01 3,028,903 182,967 3,211,870 TOTAL AMOUNT $14,164,742 $851,149 $ 15,015,891
B-4 NO1-HD-6-3259 Section C SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT C.1 WORK STATEMENT/SPECIFICATIONS (NIH 1040B) (JUL 1986) Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work/Specifications set forth in Section J attached hereto and made a part of this document. C-1 NO1-HD-6-3259 Section D SECTION D - PACKAGING AND MARKING --------------------------------- [For this Contract, there are NO clauses in this Section] D-1 NO1-HD-6-3259 Section E SECTION E - INSPECTION AND ACCEPTANCE ------------------------------------- E.1 NOTICE LISTING CONTRACT CLAUSES INCORPORATED BY REFERENCE The following contract clauses pertinent to this section are hereby incorporated by reference (by Citation Number, Title, and Date) in accordance with the clause at FAR "52.252-2 CLAUSES INCORPORATED BY REFERENCE (JUN 1988)" in Section I of this contract. NUMBER TITLE DATE FEDERAL ACQUISITION REGULATION (48 CFR Chapter 1) 52.246-9 INSPECTION OF RESEARCH AND DEVELOPMENT APR 1984 (SHORT FORM) E.2 INSPECTION AND ACCEPTANCE (NIH 3045) (MAY 1989) (a) The Contracting Officer or the duly authorized representative will perform inspection and acceptance of materials and services to be provided. (b) For the purposes of this CLAUSE the designated Project Officer is the authorized representative of the Contracting Officer. (c) Inspection and acceptance will be performed by the Project Officer at the address listed in the clause "Project Officer" in Section G. (d) Acceptance may be presumed unless otherwise indicated in writing by the Contracting Officer or the duly authorized representative within 30 days of receipt. E-1 NO1-HD-6-3259 Section F SECTION F - DELIVERIES OR PERFORMANCE ------------------------------------- F.1 NOTICE LISTING CONTRACT CLAUSES INCORPORATED BY REFERENCE The following contract clauses pertinent to this section are hereby incorporated by reference (by Citation Number, Title, and Date) in accordance with the clause at FAR "52.252-2 CLAUSES INCORPORATED BY REFERENCE (JUN 1988)" in Section I of this contract. NUMBER TITLE DATE FEDERAL ACQUISITION REGULATION (48 CFR Chapter 1) 52.242-15 STOP-WORK ORDER AUG 1989 ALTERNATE I (APR 1984) 52.247-34 F.O.B. DESTINATION NOV 1991 F.2 PERIOD OF PERFORMANCE (NIH 1060) (MAY 1989) The period of performance of this contract shall be from September 1, 1996 through June 30, 2001. The period of performance includes submission of any final report and all other deliverables set forth in this Section F and/or in the work statement/specifications of Section C. Precontract costs shall be covered from the period July 1, 1996 through August 31, 1996. F.3 LEVEL OF EFFORT--COST-REIMBURSEMENT TERM CONTRACT (NIH 1050) (NOV 1988) (a) During the period of performance of this contract and the precontract cost period, the Contractor shall provide 150,580 direct labor hours. The effort does not include vacation, sick leave and holiday. The effort includes any subcontractor labor effort. (b) It is estimated that the labor effort is constituted as specified below and will be expended approximately as follows: MEDICAL CENTER LABOR CATEGORY YR 1 YR 2 YR 3 YR 4 YR5 Principal Investigator 1,880 1,880 1,880 1,880 1,880 Manager, Bioassay/Tox. 1,880 1,880 1,880 1,880 1,880 Manager, Immunoassay/ Biochemistry 1,880 1,880 1,880 1,880 1,880 BIO/TOX Technicians 9,856 9,856 9,856 9,856 9,856 IMMUNO/BIOCHEM Techs. 5,640 5,640 5,640 5,640 5,640 F-1 NO1-HD-6-3259 Section F Animal Technicians 4,216 4,216 4,216 4,216 4,216 Quality Assurance 94 94 94 94 94 TOTAL MEDICAL CENTER 25,446 25,446 25,446 25,446 25,446 RESEARCH BOULEVARD LABOR CATEGORY Veterinarian 226 226 226 226 226 BIO/TOX Technicians 2,068 2,068 2,068 2,068 2,068 Animal Technicians 2,376 2,376 2,376 2,376 2,376 TOTAL RESEARCH BLVD. 4,670 4,670 4,670 4,670 4,670 TOTAL DIRECT LABOR 30,116 30,116 30,116 30,116 30,116
F.4 VARIATIONS IN PERFORMANCE--TOTAL EFFORT (NIH 3030) (JUL 1986) The Contractor shall have satisfied the requirement herein if not less than 90% nor more than 110% of the total effort specified above is furnished. In the event less effort than the minimum specified number of direct labor effort in the total categories is used by the Contractor in accomplishing the prescribed work and the Government has not invoked its rights under FAR Clause 52.249-6, TERMINATION (Cost-Reimbursement), incorporated in this contract, these parties agree that the fee will be adjusted based solely upon the quantity of effort by which the number furnished is less than the effort specified in this Section F. The resulting adjustment shall be evidenced by a contract modification. F.5 REPORTING REQUIREMENTS (NIH 3055B) (MAR 1988) Technical Reporting Requirements needed for performance of this contract are set forth as an attachment as listed in Section J. F-2 NO1-HD-6-3259 Section G SECTION G - CONTRACT ADMINISTRATION DATA ---------------------------------------- G.1 KEY PERSONNEL (NIH 3060) (JUL 1986) (a) The personnel specified in this contract are considered to be essential to the work being performed hereunder. Prior to diverting any of the specified individuals to other programs, the Contractor shall notify the Contracting Officer reasonably in advance and shall submit justification (including proposed substitutions) in sufficient detail to permit evaluation of the impact on the program. No diversion shall be made by the Contractor without the written consent of the Contracting Officer; provided, that the Contracting Officer may ratify in writing such diversion and such ratification shall constitute the consent of the Contracting Officer required by this clause. The contract may be amended from time to time during the course of the contract to either add or delete personnel, as appropriate. (b) The following individuals are considered to be essential to the performance hereunder:
NAME TITLE Jerry R. Reel, Ph.D. Principal Investigator Sheri Hild-Petito, Ph.D. Manager, Bioassay/Toxicology Janice M. Larner, Ph.D. Manager, Immunoassay/Biochemistry
G.2 PROJECT OFFICER (NIH 1900) (NOV 1988) The following Project Officer(s) will represent the Government for the purpose of this contract: Richard P. Blye, Ph.D. Contraceptive Development Branch, NICHD Executive Building, Suite 8B13P 6100 Executive Blvd., MSC 7510 BETHESDA MD 20892-7510 The Project Officer is responsible for (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptance required by this contract; and (5) assisting in the resolution of technical problems encountered during performance. G-1 NO1-HD-6-3259 Section G The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the Statement of Work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the contractor any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract. The Government may unilaterally change its Project Officer designation. G.3 INDIRECT COST RATES (NIH 1295) (JUL 1986) (a) In accordance with Federal Acquisition Regulation (FAR) (48 CFR Chapter 1) Clause 52.216-7(d)(2), Allowable Cost and Payment incorporated by reference in this contract in Section I, the cognizant Contracting Officer responsible for negotiating provisional and/or final indirect cost rates is identified as follows: Chief, Financial Advisory Services Branch Division of Contracts and Grants, NIH Executive Building, Suite 6A-03 6100 Executive Blvd. MSC 7510 Bethesda, Maryland 20892-7510 These rates are hereby incorporated without further action of the contracting officer. G.4 INVOICE SUBMISSION (NIH RC-IA) (DEC 1988) ALTERNATE I Invoice/Financing Request Instructions for NIH Cost-Reimbursement Type Contracts, NIH(RC)-1, are attached and made part of this contract (See Attachment in Section J). The instructions and the following directions for the submission of invoice/financing requests must be followed to meet the requirements of a "proper" payment request, pursuant to FAR 32.9. (a) Invoices/financing requests shall be submitted concurrently as follows: (1) An original and two copies to the following designated payment office: National Institutes of Health Office of Financial Management Chief, Contract Accounting Branch Building 31, Room B1BO5A 31 CENTER DR. MSC 2050 BETHESDA, MARYLAND 20892-2050 (2) Three copies to the contracting officer at the issuing G-2 NO1-HD-6-3259 Section G address on page 1 of Section A. (b) Inquiries regarding payments should be directed to the designated payment office, attention: Chief, Contract Accounting Branch, (301) 496-6452. G.5 CONTRACT FINANCIAL REPORT (NIII 2706) (APR 1992) (See Attachment in Section J) (a) Financial reports on the attached Form NIH-2706, Financial Report of Individual Project/Contract, shall be submitted by the Contractor in accordance with the instructions which accompany the form, in an original and two copies, not later than thirty (30) working days after the close of the reporting period. The line entries for subdivisions of work and elements of cost (expenditure categories) which shall be reported within the total contract are listed in paragraph (e) below. Subsequent, changes and/or additions in the line entries shall be made in writing. (b) The first financial report shall cover the period consisting of the first full three calendar months following the date of the contract, in addition to any fractional part of the initial month. Thereafter, reports shall be submitted on a QUARTERLY basis. (c) The Contracting Officer may require the Contractor to submit detailed support for costs contained in one or more interim financial reports. This clause does not supersede the record retention requirements in FAR Part 4.7. (d) Unless otherwise stated in that part of the NIH 2706, Instructions, entitled "Preparation Instructions" all columns A through J, shall be completed for each report submitted. (e) The following expenditure categories shall be reported: (Expenditures shall be reported in detail as set forth in the attached NIH 2706.) G.6 GOVERNMENT PROPERTY (NIH 3065) (JUL 1986) (a) In addition to the requirements of the clause, GOVERNMENT PROPERTY, referenced in SECTION I of this contract, the Contractor shall comply with the DHHS Publication, CONTRACTOR'S GUIDE FOR CONTROL OF GOVERNMENT PROPERTY, (1990), which is incorporated into this contract by reference. Among other issues, this publication provides a summary of the Contractor's responsibilities regarding purchasing authorizations, inventory, and reporting requirements under the contract. A copy of this publication is available upon request to the Contract Property Administrator at the following address: Contract Property Administrator G-3 NO1-HD-6-3259 Section G Research Contracts Property Administration, NIH Building 13, Room 2E-65 9000 Rockville Pike Bethesda, Maryland 20892 (301) 496-6467 G.7 GOVERNMENT FURNISHED PROPERTY - SCHEDULE II-A NIH 3065c) (JUL 1986) Pursuant to the Clause, GOVERNMENT PROPERTY, referenced in SECTION I of this contract, the Contractor is hereby authorized to retain custody of the property listed in the attached Schedule II-A for use in direct performance of this contract. Accountability for the items listed in Schedule II-A is hereby transferred to this contract from predecessor Contract No. NO1-HD-1-3130, under which these items were provided by the Government. Title to this property shall remain in the Government. G-4 NO1-HD-6-3259 Section H SECTION H - SPECIAL CONTRACT REQUIREMENTS H.1 HHSAR 352.270-6 PUBLICATIONS AND PUBLICITY (JUL 1991) (a) Unless otherwise specified in this contract, the Contractor is encouraged to publish the results of its work under this contract. A copy of each article submitted by the Contractor for publication shall be promptly sent to the Project Officer. The Contractor shall also inform the Project Officer when the article or other publication is published, and furnish a copy of it as finally published. (b) The Contractor shall include in any publication resulting from work performed under this contract a disclaimer reading as follows: The content of this publication does not necessarily reflect the views or policies of the Department of Health and Human Services, nor does mention of trade names, commercial products, or organizations imply endorsement by the U.S. Government. H.2 PHS 352.223-70 SAFETY AND HEALTH (APR 1984) (a) In order to provide safety controls for protection to the life and health of employees and other person; for prevention of damage to all property; and for avoidance of work interruptions in the performance of the contract; the Contractor will comply with the following standards: (Insert codes, standards, and criteria (including any applicable State and local requirements) prescribed by the Safety Officer). Further, the Contractor shall take or cause to be taken such additional safety measures as the Contracting Officer may determine to be reasonably necessary; Provided, that, if compliance with such additional safety measures results in a material increase in the cost or time of performance of the contract, an equitable adjustment will be made in accordance with the clause of this contract entitled "Changes." (b) Prior to commencement of work, the Contractor will submit in writing its plan for complying with the safety and health provisions of this contract, and will meet with the Contracting Officer or his/her designated representative to discuss and develop a mutual understanding relative to administration of the overall safety program. H-1 NO1-HD-6-3259 Section H (c) During the performance of work under this contract, the Contractor shall comply with all procedures prescribed by the Contracting Officer for the control and safety of persons visiting the job site and will comply with such requirements to prevent accidents as may be prescribed by the Contracting Officer. (d) The Contractor will maintain an accurate record of, and report to the Contracting Officer in such manner as the Contracting Officer may prescribe, all accidents and incidents resulting in death, traumatic injury, occupational disease, and/or damage to all property incident to work performed under the contract. (e) The Contracting Officer shall notify (if otherwise, confirm in writing) the Contractor of any noncompliance with the provisions of this clause and corrective action to be taken. After receipt of such notice, the Contractor shall immediately take such corrective action. (Such notice, when delivered to the Contractor or its representative at the site of the work, shall be deemed sufficient for the purpose.) If the Contractor fails or refuses to comply promptly, the Contracting Officer may issue an order stopping all or part of the work until satisfactory corrective action has been taken. No part of the time lost due to any such stop order shall be the subject of claim for extension of time or for costs or damages by the Contractor. (f) The Contractor shall insert the substance of this clause in each subcontract involving the use of hazardous materials or operations. Compliance with the provisions of this clause by subcontractors will be the responsibility of the Contractor. H.3 HUMAN SUBJECTS (NIH 3085) (JUL 1986) It is hereby understood and agreed that research involving human subjects shall not be conducted under this contract, and that no material developed, modified, or delivered by or to the Government under this contract, or any subsequent modification of such material, will be used by the Contractor or made available by the Contractor for use by anyone other than the Government, for experimental or therapeutic use involving humans without the prior written approval of the Contracting Officer. H.4 SALARY RATE LIMITATIONS LEGISLATION (NIH 3102) (OCT 1993) (a) Pursuant to the Public Law(s) cited in paragraph b., below, no NIH Fiscal Year funds may be used to pay the direct salary of an individual through this contract at a rate in excess of the applicable amount shown for the fiscal year covered. Direct salary is exclusive of overhead, fringe benefits, and general and administrative expenses. The per year salary rate limit also applies to individuals proposed under subcontracts. If this is a multi-year contract, it may be subject to unilateral modifications by the Government if an individual's salary rate exceeds any salary rate ceiling established in future DHHS appropriation acts. H-2 NO1-HD-6-3259 Section H
(b) Public Law No. Fiscal Year Dollar Amount of Salary Limitation 104-91 1996 $125,000
H.5 ANIMAL WELFARE ASSURANCE (NIH 3200) (JUN 1993) The Contractor shall obtain, prior to the start of any work under this contract, an approved Animal Welfare Assurance from the Office of Protection from Research Risks (OPRR), Office of the Director, NIH, as required by Section I-43-30 of the Public Health Service Policy on Humane Care and Use of Laboratory Animals. The Contractor shall maintain such assurance for the duration of this contract, and any subcontractors performing work under this contract involving the use of animals shall also obtain and maintain an approved Animal Welfare Assurance. H.6 ACKNOWLEDGEMENT OF SUPPORT (NIH 3480) (FEB 1992) The contractor shall acknowledge the support of the National Institutes of Health whenever publicizing the work under this contract in any media by including an acknowledgement substantially as follows: This project has been funded in whole or in part with Federal funds from the National Institute of Child Health and Human Development, National Institutes of Health, under Contract Number NO1-HD-6-3259. H-3 NO1-HD-6-3259 Section I PART II - CONTRACT CLAUSES SECTION I - CONTRACT CLAUSES ---------------------------- I.1 CONTRACT CLAUSES (NIH 3105B) (MAR 1988) The clauses incorporated in this contract are formatted for the award of a Cost Plus Fixed Fee-Term contract with a commercial organization. I.2 CLAUSES INCORPORATED IN FULL TEXT (NIH 3110) (JUL 1986) The following National Institutes of Health clauses are incorporated in full text and included as attachments listed in Section J: NIH(RC)-1 JUN 1992 Invoice/Financing Request Instructions for NIH Cost-Reimbursement Type Contracts NIH(RC)-7 APR 1984 Procurement of Certain Equipment (OMB Bulletin 81-16) I.3 NOTICE LISTING CONTRACT CLAUSES INCORPORATED BY REFERENCE The following contract clauses pertinent to this section are hereby incorporated by reference (by Citation Number, Title, and Date) in accordance with the clause at FAR "52.252-2 CLAUSES INCORPORATED BY REFERENCE (JUN 1988)" in Section I of this contract.
NUMBER TITLE DATE FEDERAL ACQUISITION REGULATION (48 CFR Chapter 1) 52.203-3 GRATUITIES APR 1984 52.203-5 COVENANT AGAINST CONTINGENT FEES APR 1984 52.203-6 RESTRICTIONS ON SUBCONTRACTOR SALES TO JUL 1995 THE GOVERNMENT 52.203-7 ANTI-KICKBACK PROCEDURES JUL 1995 52.203-10 PRICE OR FEE ADJUSTMENT FOR ILLEGAL OR SEP 1990 IMPROPER ACTIVITIES 52.203-12 LIMITATION ON PAYMENTS TO INFLUENCE JAN 1990 CERTAIN FEDERAL TRANSACTIONS 52.204-4 PRINTING/COPYING DOUBLE-SIDED ON MAY 1995 RECYCLED PAPER 52.209-6 PROTECTING THE GOVERNMENT'S INTEREST AUG 1995 WHEN SUBCONTRACTING WITH CONTRACTOR'S
I-1 NO1-HD-6-3259 Section I DEBARRED, SUSPENDED, OR PROPOSED FOR DEBARMENT 52.215-2 AUDIT AND RECORDS--NEGOTIATION OCT 1995 52.215-31 WAIVER OF FACILITIES CAPITAL COST OF SEP 1987 MONEY 52.215-33 ORDER OF PRECEDENCE JAN 1986 52.216-7 ALLOWABLE COST AND PAYMENT JUL 1991 52.216-8 FIXED-FEE APR 1984 52.219-8 UTILIZATION OF SMALL, SMALL OCT 1995 DISADVANTAGED BUSINESS AND WOMEN-OWNED SMALL BUSINESS CONCERNS 52.222-3 CONVICT LABOR APR 1984 52.222-26 EQUAL OPPORTUNITY APR 1984 52.222-28 EQUAL OPPORTUNITY PREAWARD CLEARANCE OF APR 1984 SUBCONTRACTS 52.222-35 AFFIRMATIVE ACTION FOR SPECIAL DISABLED APR 1984 AND VIETNAM ERA VETERANS 52.222-36 AFFIRMATIVE ACTION FOR HANDICAPPED APR 1984 WORKERS 52.222-37 EMPLOYMENT REPORTS ON SPECIAL DISABLED JAN 1988 VETERANS AND VETERANS OF THE VIETNAM ERA 52.223-2 CLEAN AIR AND WATER APR 1984 52.223-6 DRUG-FREE WORKPLACE JUL 1990 52.225-11 RESTRICTIONS ON CERTAIN FOREIGN MAY 1992 PURCHASES 52.227-1 AUTHORIZATION AND CONSENT JUL 1995 ALTERNATE I (APR 1984) 52.227-2 NOTICE AND ASSISTANCE CONCERNING PATENT APR 1984 AND COPYRIGHT INFRINGEMENT 52.227-11 PATENT RIGHTS -- RETENTION BY THE JUN 1989 CONTRACTOR (SHORT FORM) NOTE: In accordance with FAR 27.303(a)(2) paragraph (f) is modified to include the requirements in FAR 27.303 (a)(2)(i) thru (iv). The frequency of reporting in (i) is annual. 52.227-14 RIGHTS IN DATA--GENERAL JUN 1987 52.227-16 ADDITIONAL DATA REQUIREMENTS JUN 1987 52.232-9 LIMITATION ON WITHHOLDING OF PAYMENTS APR 1984 52.232-17 INTEREST JUN 1996 52.232-22 LIMITATION OF FUNDS APR 1984 52.232-23 ASSIGNMENT OF CLAIMS JAN 1986 52.232-25 PROMPT PAYMENT MAR 1994 52.232-28 ELECTRONIC FUNDS TRANSFER PAYMENT METHOD APR 1989 52.233-1 DISPUTES OCT 1995 52.233-3 PROTEST AFTER AWARD OCT 1995 ALTERNATE I (JUN 1985) 52.242-1 NOTICE OF INTENT TO DISALLOW COSTS APR 1984 52.242-3 PENALTIES FOR UNALLOWABLE COSTS OCT 1995 52.242-13 BANKRUPTCY JUL 1995 52.243-2 CHANGES--COST REIMBURSEMENT AUG 1987 ALTERNATE V (APR 1984) 52.244-2 SUBCONTRACTS (COST-REIMBURSEMENT AND MAR 1996 LETTER CONTRACTS) 52.244-5 COMPETITION IN SUBCONTRACTING JAN 1996 52.245-5 GOVERNMENT PROPERTY (COST-REIMBURSEMENT, JAN 1986
I-2 NO1-HD-6-3259 Section I TIME AND MATERIALS, OR LABOR HOUR CONTRACTS) 52.245-19 GOVERNMENT PROPERTY FURNISHED "AS IS" APR 1984 52.246-23 LIMITATION OF LIABILITY APR 1984 52.246-25 LIMITATION OF LIABILITY--SERVICES APR 1984 52.249-6 TERMINATION (COST-REIMBURSEMENT) MAY 1986 52.249-14 EXCUSABLE DELAYS APR 1984 52.253-1 COMPUTER GENERATED FORMS JAN 1991 HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (48 CFR Chapter 3) CLAUSES: HHSAR NUMBER TITLE DATE 352.202-1 DEFINITIONS APR 1984 ALTERNATE I (APR 1984) 352.228-7 INSURANCE--LIABILITY TO THIRD PERSONS DEC 1991 352.232-9 WITHHOLDING OF CONTRACT PAYMENTS APR 1984 352.233-70 LITIGATION AND CLAIMS APR 1984 352.242-71 FINAL DECISIONS ON AUDIT FINDINGS APR 1984 352.270-7 PAPERWORK REDUCTION ACT APR 1984 PUBLIC HEALTH SERVICES ACQUISITION REGULATIONS (48 CFR Chapter 3, Appendix A) CLAUSES:
PHSAR NUMBER TITLE DATE 352.280-2 (b) CARE OF LIVE VERTEBRATE ANIMALS OCT 1986
I.4 52.203-9 REQUIREMENT FOR CERTIFICATE OF PROCUREMENT INTEGRITY-MODIFICATION (SEP 1995) (a) Definitions. The definitions set forth in FAR 3.104-4 are hereby incorporated in this clause. (b) The Contractor agrees that it will execute the certification set forth in paragraph (c) of this clause when requested by the Contracting Officer in connection with the execution of any modification of this contract. (c) Certification. As required in paragraph (b) of this clause, the officer or employee responsible for the modification proposal shall execute the following certification. The certification in paragraph (c)(2) of this clause is not required for a modification which procures commercial items. CERTIFICATE OF PROCUREMENT INTEGRITY--MODIFICATION (NOV 1990) (1) I, ___________________________________________________________ [Name of certifier] am the officer or employee responsible for the preparation of this modification proposal and hereby certify that, to the best of my knowledge and belief, I-3 NO1-HD-6-3259 Section I with the exception of any information described in this certification, I have no information concerning a violation or possible violation of subsection 27(a), (b), (d), or (f) of the Office of Federal Procurement Policy Act, as amended * (41 U.S.C. 423), (hereinafter referred to as "the Act"), as implemented in the FAR, occurring during the conduct of this procurement (contract and modification number). (2) As required by subsection 27(e)(1)(B) of the Act, I further certify that to the best of my knowledge and belief, each officer, employee, agent, representative, and consultant of ____________________________________ [Name of Offeror] who has participated personally and substantially in the preparation or submission of this proposal has certified that he or she is familiar with, and will comply with, the requirements of subsection 27(a) of the Act, as implemented in the FAR, and will report immediately to me any information concerning a violation or possible violation of subsections 27(a), (b), (d), or (f) of the Act, as implemented in the FAR, pertaining to this procurement. (3) Violations or possible violations: (Continue on plain bond paper if necessary and label Certificate of Procurement Integrity--Modification (Continuation Sheet), ENTER NONE IF NONE EXISTS) _______________________________________________________________________ _______________________________________________________________________ _______________________________________________________________________ _______________________________________________________________________ [Signature of the officer or employee responsible for the modification proposal and date] _______________________________________________________________________ [Typed name of the officer or employee responsible for the modification proposal] * Subsections 27(a), (b), and (d) are effective on December 1, 1990. Subsection 27(f) is effective on June 1, 1991. THIS CERTIFICATION CONCERNS A MATTER WITHIN THE JURISDICTION OF AN AGENCY OF THE UNITED STATES AND THE MAKING OF A FALSE, FICTITIOUS, OR FRAUDULENT CERTIFICATION MAY RENDER THE MAKER SUBJECT TO PROSECUTION UNDER TITLE 18, UNITED STATES CODE, SECTION 1001. (End of certification) (d) In making the certification in paragraph (2) of the certificate, the officer or employee of the competing Contractor responsible for the offer or bid, may rely upon a one-time I-4 NO1-HD-6-3259 Section I certification from each individual required to submit a certification to the competing Contractor, supplemented by periodic training. These certifications shall be obtained at the earliest possible date after an individual required to certify begins employment or association with the contractor. If a contractor decides to rely on a certification executed prior to the suspension of section 27 (i.e., prior to December 1, 1989), the Contractor shall ensure that an individual who has so certified is notified that section 27 has been reinstated. These certifications shall be maintained by the Contractor for a period of 6 years from the date a certifying employee's employment with the company ends or, for an agency, representative, or consultant, 6 years from the date such individual ceases to act on behalf of the contractor. (e) The certification required by paragraph (c) of this clause is a material representation of fact upon which reliance will be placed in executing this modification. I.5 52.222-2 PAYMENT FOR OVERTIME PREMIUMS (JUL 1990) (a) The use of overtime is authorized under this contract if the overtime premium cost does not exceed $54,662 or the overtime premium is paid for work-- (1) Necessary to cope with emergencies such as those resulting from accidents, natural disasters, breakdowns of production equipment, or occasional production bottlenecks of a sporadic nature; (2) By indirect-labor employees such as those performing duties in connection with administration, protection, transportation, maintenance, standby plant protection, operation of utilities, or accounting; (3) To perform tests, industrial processes, laboratory procedures, loading or unloading of transportation conveyances, and operations in flight or afloat that are continuous in nature and cannot reasonably be interrupted or completed otherwise; or (4) That will result in lower overall costs to the Government. (b) Any request for estimated overtime premiums that exceeds the amount specified above shall include all estimated overtime for contract completion and shall-- (1) Identify the work unit; e.g., department or section in which the requested overtime will be used, together with present workload, staffing, and other data of the affected unit sufficient to permit the Contracting Officer to evaluate the necessity for the overtime; (2) Demonstrate the effect that denial of the request will have on the contract delivery or performance schedule; I-5 NO1-HD-6-3259 Section I (3) Identify the extent to which approval of overtime would affect the performance or payments in connection with other Government contracts, together with identification of each affected contract; and (4) Provide reasons why the required work cannot be performed by using multishift operations or by employing additional personnel. I.6 52.252-2 CLAUSES INCORPORATED BY REFERENCE (JUN 1988) This Contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. I-6 NO1-HD-6-3259 Section J PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS SECTION J - LIST OF ATTACHMENTS ------------------------------- J.1 LIST OF ATTACHMENTS (NIH 1365) (JUL 1986)
Title Date Pages a. Statement of Work N/A 4 b. Technical Reporting Requirements N/A 2 c. Financial Report of Individual 5/92 6 Project/Contract, NIH Form 2706 d. Invoice/Financing Request 6/92 4 Instructions for NIH Cost-Reimbursement Type Contracts, NIH(RC)-1 e. Procurement of Certain 4/84 1 Equipment, NIH(RC)-7 f. Government Furnished Property N/A 1 Schedule - II-A
J-1 Attachment J.1.a STATEMENT OF WORK A. General Description of the Required Objectives and Desired Results. Independently and not as an agent of the Government, the Contractor shall furnish all necessary services, qualified personnel, material equipment and facilities not otherwise provided by the Government as needed to maintain and operate a Biological Testing Facility for the exclusive use of the Contraceptive Development Branch. B. Technical Requirements. Specifically, the contractor shall: 1. Maintain separate animal facilities for housing rodents, rabbits and rhesus monkeys in compliance with all existing Federal, State and NIH guidelines and with accreditation by AAALAC. The maximum anticipated capacity for a given species at any one time is provided in Exhibit II. 2. Provide for individual caging of all animals during all experimental studies except for those periods of cohabitation required for mating. Monkeys may require paired caging at other times. Animal rooms for a given species will be maintained with separate controls for light, temperature and humidity. 3. Maintain a duly constituted animal care and use committee throughout the contract period for the review of new experimental protocols and animal health and welfare. 4. Submit articles including drugs, devices and delivery systems for evaluation and assignment for testing by the Project Officer or procured by the contractor from other sources as requested by the Project Officer. 5. Maintain an inventory of test articles containing dates of receipts of materials, quantity used in test procedures and the amount on hand at any given time. Contractor shall also keep a log of all distributions of test articles including the sample size, date and recipient. 6. All materials submitted for testing shall remain the property of the Government or the supplier to the Government. Disposition of materials remaining after completion of testing shall be specified by the Project Officer. 7. Establish and maintain laboratory procedures and controls to provide for the safety of personnel and facilities; as any test material may, under certain circumstances, be irritating, toxic or otherwise hazardous. 8. Prepare test materials in appropriate vehicles for administration to animals as specified by the Project Officer and/or in accordance with specifications outlined in Exhibit III. 9. Provide space for the orderly storage of submissions at room temperature, at approximately 4 degree C, -5 degree C, -20 degree C and at -80 degree C. 10. Provide locked storage space with restricted access for controlled substances. 11. Undertake any or all of the tests listed in Exhibit IV. 12. Administer test materials by conventional routes such as subcutaneous, intravenous, intramuscular, intravaginal, oral and subdermal but be prepared to undertake unusual routes of administration when necessary. 13. Observe and record changes in behavior and external organs, conduct necropsies for obtaining specified tissues and organs, record organ weights, preserve specified tissues for histological processing including the preparation of stained sections for microscopic examination and obtain photographs of animals, organs and tissues as part of the laboratory record. Contractor shall also undertake gross and microscopic pathology of tissues and organs using, where necessary, expert consultants (Board Certified) in the field. Contractor shall also undertake surgical procedures such as gonadectomies and those required for the placement of drug delivery devices. 14. Obtain approval of the Project Officer for modifications of experimental protocols. 15. Draw bloods at specified periods and prepare serum samples for radioimmunoassay of sex steroids including estradiol, estrone, total estrogens, testosterone, dihydrotestosterone, total androgens, progesterone and protein hormones including FSH and LH. Radioimmunoassay of other drugs may be required. The Government will furnish reagents for these assays where they are not available commercially. 16. Provide for the experience and capability of developing new radioimmunoassays including the production of antisera and radioligands when necessary. 17. Undertake the assay of the clinical chemistries outlined in Exhibit V for blood and urine samples in house or through consulting services. 18. Undertake preclinical drug safety studies in rodents and/or rabbits up to 6 months in duration under GLP guidelines. Clinical chemistries, urinalysis, hematology and full pathology may be required for these and for other preclinical evaluation (Exhibits V, VI, VII, VIII). It is not possible to predict the number of these studies which will be required during the contract period. These studies may be undertaken in house or through consulting services in part or in toto. 19. All tests and ancillary procedures employed by the contractor shall be consistent with the goals of the program and the highest standards of laboratory conduct and animal welfare. 20. Enter raw data into standard laboratory notebooks with provision for permanent (original) and tear-out pages as outlined in Exhibit IX. Each page will be signed and dated by the investigator and properly witnessed. Each notebook will be numbered. No erasures in the laboratory notebook are to be made; errors are to be lightly crossed out, correction added and the correction initialed and dated by the investigator. Tear-out pages will be available to the Project Officer on request. Raw data will be entered into the NICHD data management system on a remote basis using government-furnished equipment. Raw and/or summary data and analyses shall be submitted to the Project Officer on a regular basis, usually weekly. Contractor shall provide adequate space for a computer terminal and ancillary equipment as well as the storage of all hard copies of data sheets and notebooks. 21. Analyze raw data using conventional methods appropriate for the study. Under certain circumstances contractor shall undertake specific statistical procedures as requested by the Project Officer. 22. All data obtained under the contract shall remain the property of the Government and/or the supplier of test materials and may not be published or otherwise disseminated without specific permission from the Project Officer. 23. Make available to the Government at all times the status of all tests including all laboratory notebooks, data analyses, etc. Frequent communication with the testing facility is essential to expeditious drug evaluation and the contractor shall ensure that one of the individuals under the contract with access to the status of all studies currently in progress shall be available at all times. 24. Send frozen sera and/or tissues from study animals to other laboratories for analyses upon request form the Project Officer. 25. Initiate the development and use of nonradiometric assays in the place of conventional raioassays as they may become available and validated and as appropriate. 26. Participate in the development of redesigned procedures for entering data in the NICHD data management system. 27. Participate with CDB staff in the preparation of papers, reports and articles for publication in scientific journals or for submission to the Food and Drug Administration or other appropriate organizations. The dissemination of data generated under the contract to other scientists is encouraged when the proprietary or confidential nature of the information will not be compromised. Accordingly, Project Officer approval is required for the release of all data obtained under the contract. 28. Schedule all testing in an expeditious manner to ensure optimal efficiency of operation for the entire program. 29. Provide adequate and appropriate organizational support for all aspects of the testing program. EXHIBIT I PERSONNEL REQUIREMENTS
TITLE LEVEL OF EFFORT Principal Investigator* 100% Manager, Bioassay* 100% Manger, Immunoassay* 100% Bioassay Technicians* 500% Immunoassay Technicians* 300% Small Animal Caretakers 200% Veterinarian 12% Primate Technicians 100% Primate Animal Caretaker 100% Quality Assurance Officer 10% WEEKEND AND HOLIDAY PREMIUM TIME Bioassay Technician 25% Small Animal Caretaker 25% Primate Technician 10% Primate Animal Caretaker 25%
*Individual must be assigned to the contract fulltime EXHIBIT II MAXIMUM ANTICIPATED ANIMAL HOUSING CAPACITY AND ANNUAL ANIMAL REQUIREMENTS BY SPECIES
SPECIES CAPACITY ANNUAL REQUIREMENT Rats 2000* 6,000* Rabbits 200** 600** Rhesus monkeys 45 45
*Assume 20% immature animals for budget purposes only. **Assume 50% immature animals for budget purposes only. EXHIBIT III Preparation, Handling and Administration of Test Materials A. Precautions Contractor will be expected to take all necessary and reasonable precautions to protect employees handling test materials and will supply suitable protective clothing and equipment. Employees will follow procedures consistent with acceptable laboratory practice designed to guard against personal injury. B. Physical Properties 1. Whenever possible, physical data such as solubility, m.p., b.p., stability and potential hazards in use will be supplied with the test material. 2. Compounds known or suspected to be unstable will be handled strictly according to instructions supplied with the Compound Submission Form. C. Storage Compounds received for testing shall be stored under refrigeration (approximately 5 degrees C) unless otherwise specified. Formulations of test materials remaining after medication will usually be discarded but under unusual circumstances CDB may request that contractors store these preparations. Storage of test materials under nitrogen, under desiccation, and/or at low temperatures (approximately -20 degrees C) may be required for some test materials. D. Preparation 1. Instructions for preparing test materials will usually be provided on the Compound Submission Form. 2. Where compounds are not soluble in the recommended vehicle, contractor will contact the Project Officer to discuss alternative vehicles. When suspensions are to be employed, every effort will be made to reduce particle size to a minimum by non-destructive methods. 3. The following vehicles will usually be used in the formulation of test compounds: distilled water, sterile saline, ethyl alcohol, various buffers and various pH's, propylene glycol, sesame oil, olive oil, corn oil, and aqueous suspending vehicle (0.9% sodium chloride, 0.4% polysorbate 80, 0.5% carboxymethylcellulose and 0.9% benzyl alcohol). 4. Dilution of the initial concentration of test material in vehicle will be made so that the volume remains constant for each dose level employed. EXHIBIT III - Page 2 5. Following the preparation of appropriate concentrations of the test material for each dose level to be employed, all solutions (suspensions) will be stored under refrigeration in air-tight vessels. Test solutions will be brought to room temperature prior to administration and returned to the refrigerator immediately following medication. 6. Should test materials come out of solution following refrigeration and remain so after attaining room temperature, warming the preparation to redissolve the test material will be permitted to the extent indicated on the Compound Submission Form. E. Administration 1. Test materials will be administered as indicated on the Compound Submission Form. Ball-tipped needles in the largest gauge (smallest diameter) consistent with the passage of vehicle employed will be used for gavaging animals. 2. In addition to oral administration, medication by intramuscular, intravenous, intraperitoneal, subcutaneous and subdermal injections will be employed where specified. 3. Dilution of stock solutions (suspensions) will be made so that the volume to be administered for each dose level remains constant. 4. Separate syringes and needles will be used for each dose level. 5. In general, the volume of vehicle containing test material will be between 0.1 and 1.0 ml in rats, between 0.1 and 5.0 ml in rabbits and up to 10 ml in monkeys. The smallest feasible volume in the ranges shown above will be utilized. 6. Control animals will ordinarily receive an equivalent volume of the vehicle used for the test material. 7. In those tests requiring a comparison of the biological activity of experimental substances with that of known standards (determination of potency estimates, relative potency, etc.), the standard employed will be administered in the same vehicle as that of the test material with which a comparison is being made. F. Selection of Dose Levels 1. In general, dose levels will be selected which will provide the data required most expeditiously. 2. Dose levels for each test substance will ordinarily be specified on the Compound Submission Form. EXHIBIT III - Page 3 G. Drug Delivery Systems and Devices 1. Drug delivery systems and devices may require surgical implantation at one or several locations of the body surface or within body cavities. 2. Sterile technique, will be employed whenever skin incisions or intrauterine placement are required. EXHIBIT IV A. Antifertility- female 1. Broad screen (primary) - rat 2. Mode of action studies (secondary) a. Antiovulatory - rat, rabbit, monkey b. Luteolytic - rat, monkey c. Postcoital (studies to determine effect on sperm transport, fertilization, cleavage, zygote transport, intrauterine growth and development, prenidatory changes and implantation - rat and rabbit 3. Duration of antifertility activity - rat, rabbit, monkey B. Antifertility - male 1. Broad screen (primary) - rat 2. Mode of action studies (secondary) - rat, rabbit, monkey a. Effect on discrete stages of spermatogenesis b. Effect on sperm maturation and storage c. Effect on sperm transport d. Effects on Leydig and Sertoli cells e. Effect on sperm morphology and motility f. Effect on capacitation 3. Endocrine profile 1. 1. Androgen - immature castrated male rat a. Screen b. Assay c. Duration of action 2. Anti-androgen - immature castrated male rat a. Screen b. Assay EXHIBIT IV - Page 2 3. Estrogen - immature female rat and rabbit a. Screen b. Assay c. Duration of activity 4. Anti-estrogen - rat and rabbit a. Screen b. Assay 5. Progestational (Clauberg and McGinty) - immature female rabbit a. Screen b. Assay c. Duration of action 6. Progestational (pregnancy maintenance) - rat a. MED b. Optimal progestogen/estrogen ratio 7. Antiprogestational a. (Clauberg) - immature female rabbit b. (anti-McGinty) - immature female rabbit 8. Corticoid screen and assay - rat a. Thymolytic b. Glycogenic c. Na/K excretion d. Anti-inflammatory 9. Gonadotrophic - rat 10. Antigonadotrophic - rat EXHIBIT IV - Page 3 D. In vitro tests 1. Histamine release by mast cells 2. Spermicidal - rabbit E. Radioimmunoassay - rat, rabbit, monkey, baboon, and human sera 1. Estradiol 2. Estrone 3. Total Estrogens 4. Progesterone 5. Testosterone and dihydrotestosterone 6. Total Androgens 7. FSH 8. LH 9. T3, T4 10. TSH 11. Other such as norethindrone, levonorgestrel, ethynylestradiol (anti-body and tracer to be supplied by Government where unavailable commercially). F. Receptor Binding 1. Estrogen 2. Progesterone 3. Androgen 4. Glucocorticoid EXHIBIT V Clinical Chemistries Sufficient blood samples shall be obtained for hematology (Exhibit VII) to pro- vide adequate serum or plasma for the following determinations: Albumin Albumin/globulin ratio Alkaline phosphatase BUN Calcium ion Chloride Sodium Potassium Creatinine Direct bilirubin GGTP Glucose Iron LDH Magnesium Inorganic phosphate SGOT SGPT Total bilirubin Total protein Uric Acid Lipid profile (total cholesterol, HDL, LDL, VLDL, triglycerides, total lipids, phospholipid) T T EXHIBIT VI Urinalyses Prior to study initiation and at specified intervals, overnight urine samples will be collected from all animals. These samples will be collected prior to administration of the test articles. Animals shall be fasted overnight and housed in stainless steel metabolism cages. The following parameters will be measured: Appearance and color pH Specific gravity Cells, cellular debris and crystals (microscopic) Total protein Glucose Ketones Bilirubin Hemoglobin Nitrite Urobilinogen EXHIBIT VII Hematology Blood samples shall be collected prior to administration of test articles and following the overnight fast for the collection of urine samples. The following parameters shall be measured: Hematocrit Hemoglobin Erythrocyte Count Leucocyte Count Reticulocyte Count Platelet Count Differential Count Mean Corpuscular Volume Mean Corpuscular Hemoglobin pH EXHIBIT VIII Necropsy and Histology Gross finding shall be recorded for each animal which dies during the course of the study and at unscheduled and scheduled sacrifice. The following organs shall be cleaned of adherent connective tissue and fat and weighed: adrenals, brain, heart, kidneys, liver, gonads, spleen, pituitary, thymus, thyroid, uterus, seminal vesicles and ventral prostate. Absolute and relative (organ/body weight ratio) shall be reported. The following tissues or samples thereof shall be subjected to standard histological processing and stained with hematoxylin and eosin: adrenals aorta brain (medullary, cerebellar and cortical sections) lungs (all lobes and mainstem bronchi) mammry gland and skin injection site spleen caecum mid-colon duodenum esophagus trachea eyes pancreas stomach (glandular and nonglandular) femur pituitary (both lobes) gonads* epididymis (caudal and caput) seminal vesicle ventral prostate uterus and uterocervical junction cervix vagina cervical lymph node urinary bladder heart kidney ileum (and mesenteric lymph node) thymus jejunum rectum thyroid and parathyroid liver sciatic nerve and skeletal muscle salivary glands and lymph node spinal cord sternum (bone marrow) * a portion of the testes shall also be fixed in Helly's fluid for PAS staining. EXHIBIT VIII - Page 2 Tissues shall be fixed in 10% neutral formalin unless otherwise specified by the Project Officer. Standard histological procedures shall be employed for dehydration and imbedding in paraffin. Sections will be cut at a thickness of 5 microns and stained with hematoxylin and eosin. Histological processing and subsequent examination shall initially be limited to any animals dying during the course of the study and all animals from the control and high dose groups at sacrifice. Histopathological study shall be extended to other dose groups for any tissues exhibiting drug-related alterations at the high dose. Gonads and accessory reproductive organs shall be processed and examined from all dose groups. Slides, paraffin blocks and wet tissues shall be held by the Contractor for a period of five years following completion of the contract. EXHIBIT IX Reports and Data A. In general, reports will be made in a manner and frequency specified by CDB. B. Contractor shall supply and maintain permanent type laboratory notebooks exclusively for use in the CDB Testing Program. 1. Laboratory notebooks will have a hard cover and permanently bound numbered pages each of which is followed by two (2) tear-out pages. Data will be entered on the permanent page in such a way as to be clearly reproduced on each of the two (2) succeeding tear-out pages. Both copies of the notebook tear-out sheets will be maintained on file by the contractor and submitted to the CDB on request. 2. Each laboratory notebook will be numbered and contain provisions for: a. Title page b. Table of contents c. Index 3. Each numbered page of the laboratory notebook will contain provisions for recording the following: a. Identification of test and testing level b. Test protocol c. Date of initiation of test d. Date of completion of test e. Identification of test material by code number (CDB number assigned to compound) f. Identification of test material by name (for CDB use) g. Identification of test material by structure (for CDB use) h. Experimental data i. Signature of senior investigator (so indicated) and date of signing j. Signature of witness (indicated as "read and understood by witness") not directly involved in the test and date of signing. 4. A diagonal line will be drawn across the unused portions of each laboratory notebook page. 5. Erasures will not be made on any laboratory notebook page. EXHIBIT IX - Page 2 6. Corrections will be made by drawing a line through the information to be changed and initialing and dating by the senior investigator. C. Analysis and summary of experimental data will be reduced to writing in a report form approved by CDB. D. Contractor will supply space for storage of laboratory notebooks, data summary sheets and such other information as may be considered confidential in locked files with access limited to those personnel directly involved in the testing program. E. CDB will have access to all information directly related to the testing program including all bound laboratory notebooks at any time. F. Contractor will enter and analyze all data generated on Government furnished data processing equipment. Attachment J.1.b TECHNICAL REPORTING REQUIREMENTS I. TECHNICAL REPORTS: In addition to those reports required by the terms of this contract, the Contractor shall prepare and submit the following reports during the period of performance of this contract. Quarterly reports, final report/summary report and GLP study shall be submitted to the Project Officer and Contracting Officer in the number of copies and at the addresses shown below.
Addresses No. Of Copies/Reports --------- --------------------- Richard P. Blye, Ph.D. 3 Quarterly Contraceptive Development Branch, NICHD 2 Final/Summary National Institutes of Health 5 GLP Study Reports Executive Building, Room 8B13 6100 Executive Blvd., MSC 7510 BETHESDA MD 20892-7510 Paul J. Duska, Contracting Officer 1 Quarterly Contracts Management Branch, NICHD 1 Final/Summary National Institutes of Health 1 GLP Study Report Executive Building, Room 7A07 6100 Executive Blvd., MSC 7510 BETHESDA MD 20892-7510
A. Quarterly Report: A quarterly progress report shall be submitted within 30 days after the reporting period. The quarterly report shall include the following specific information. 1) A list of all compounds, drug delivery systems and devices evaluated during the reporting period and the tests performed on each. The location of the data generated for each submission including identification of laboratory notebooks and pages and the rows in each "Drug Directory." 2) Compound, delivery system and device inventory. 3) A description of the current protocols employed for all tests and analytical procedures. 4) Animal inventory by species. 5) A discussion of all problems that have arisen during the reporting period and their resolution. B. Final Report A Comprehensive final report shall be submitted on or before the expiration date of the contract. The final report shall contain all of the information requested in the previous quarterly reports in cumulative form. The work shall be described in detail including particular attention to any modification of test protocols. The final report shall also include summary data and analysis, including a summary (not to exceed 200 words) of salient results achieved during the performance of the contract. C. GLP Study Reports The contractor shall prepare and submit to the Project Officer five (5) copies of audited final reports for all studies carried out under GLP guidelines. These reports will conform to guidelines contained in GLP regulations in effect at the time of preparation. II. Laboratory Records: The contractor shall maintain laboratory notebooks as outlined elsewhere. It is important that these notebooks contain an accurate, up-to-date record of all testing activities. Data should be entered in laboratory notebooks on a daily basis and each page properly signed, dated and witnessed. Copies of these notebook pages, as well as copies of summary sheets containing summary data and analysis shall be maintained by the contractor for submission to the Project Officer on demand. III. Computer-Based Data Storage and Analysis: The Contractor shall enter data into "drug Directories" through the CDB PROPHET Data System on a daily basis. The PROPHET System provides the principal means of access to data generated under contract and minimizes the need for the Government to store and maintain hard copies of laboratory notebook pages and individual test result reports. Page 1 of 4
==================================================================================================================================== NATIONAL INSTITUTES OF HEALTH PROJECT TITLE: "BIOLOGICAL TESTING FACILITY" FINANCIAL REPORT OF INDIVIDUAL PROJECT/CONTRACT - - ------------------------------------------------------------------------------------------------------------------------------------ NOTE: COMPLETE THIS FORM IN ACCORDANCE REPORTING PERIOD WITH ACCOMPANYING INSTRUCTIONS. - - ------------------------------------------------------------------------------------------------------------------------------------ LABOR HOURS CUMULATIVE EXPENDITURE CATEGORY INCURRED COST INCURRED CUMULATIVE AT END OF COST-CURRENT COST TO DATE NEGOTIATED ACTUAL PRIOR PERIOD PERIOD (D+E) - - ------------------------------------------------------------------------------------------------------------------------------------ A B C D E F ==================================================================================================================================== A. DIRECT LABOR Medical Center Cost Center - - ------------------------------------------------------------------------------------------------------------------------------------ J. Reel, Ph.D. Principal Investigator 9,400 - - ------------------------------------------------------------------------------------------------------------------------------------ S. Hild-Petito, Ph.D. Mngr. Bioassay/Tox 9,400 - - ------------------------------------------------------------------------------------------------------------------------------------ J. Larner, Ph.D Mngr. Immuno/Biochem 9,400 - - ------------------------------------------------------------------------------------------------------------------------------------ D. Gropp BIO/TOX Technician 9,970 - - ------------------------------------------------------------------------------------------------------------------------------------ S. Propst BIO/TOX Technician 9,970 - - ------------------------------------------------------------------------------------------------------------------------------------ B. Till BIO/TOX Technician 9,970 - - ------------------------------------------------------------------------------------------------------------------------------------ E. Curreri BIO/TOX Technician 9,970 - - ------------------------------------------------------------------------------------------------------------------------------------ B. Hembry BIO/TOX Technician 9,400 - - ------------------------------------------------------------------------------------------------------------------------------------ R. Scott Immuno/Biochem Tech. 9,400 - - ------------------------------------------------------------------------------------------------------------------------------------ L. Radler Immuno/Biochem Tech. 9,400 - - ------------------------------------------------------------------------------------------------------------------------------------ J. Burgensob Immuno/Biochem Tech. 9,400 - - ------------------------------------------------------------------------------------------------------------------------------------ S. Gormley Sm. Animal Care Tech. 10,540 - - ------------------------------------------------------------------------------------------------------------------------------------ 0. Saine Sm. Animal Care Tech. 10,540 - - ------------------------------------------------------------------------------------------------------------------------------------ L. Denenno Quality Assurance 470 - - ------------------------------------------------------------------------------------------------------------------------------------ Medical Center Director Labor Cost Total 126,760 - - ------------------------------------------------------------------------------------------------------------------------------------ DIRECT LABOR Research Blvd. Cost Center - - ------------------------------------------------------------------------------------------------------------------------------------ T. Moskal DVM Veterinarian 1,130 - - ------------------------------------------------------------------------------------------------------------------------------------ S. Harbauch BIO/TOX Technician 5,170 - - ------------------------------------------------------------------------------------------------------------------------------------ M. Sowers BIO/TOX Technician 5,170 ====================================================================================================================================
============================================================================================================== CONTRACT NO.: NO1-HD-6-3259 DATE OF REPORT: - - -------------------------------------------------------------------------------------------------------------- CONTRACTOR NAME AND ADDRESS: BIOQUAL, Inc. 9600 Medical Center Drive ROCKVILLE, MD 20850-3300 - - -------------------------------------------------------------------------------------------------------------- ESTIMATED VARIANCE EXPENDITURE CATEGORY ESTIMATED COST AT NEGOTIATED (OVER OR COST TO COMPLETION CONTRACT UNDER) COMPLETE (F+G) AMOUNT (I-H - - -------------------------------------------------------------------------------------------------------------- G H I J ============================================================================================================== A. DIRECT LABOR Medical Center Cost Center - - -------------------------------------------------------------------------------------------------------------- J. Reel, Ph.D. Principal 530,536 - - -------------------------------------------------------------------------------------------------------------- S. Hild-Petito, Ph.D. Mngr. Bioassay/Tox 323,897 - - -------------------------------------------------------------------------------------------------------------- J. Larner, Ph.D Mngr. Immuno/Biochem 347,649 - - -------------------------------------------------------------------------------------------------------------- D. Gropp BIO/TOX Technician 204,574 - - -------------------------------------------------------------------------------------------------------------- S. Propst BIO/TOX Technician 146,156 - - -------------------------------------------------------------------------------------------------------------- B. Till BIO/TOX Technician 219,611 - - -------------------------------------------------------------------------------------------------------------- E. Curreri BIO/TOX Technician 167,755 - - -------------------------------------------------------------------------------------------------------------- B. Hembry BIO/TOX Technician 157,939 - - -------------------------------------------------------------------------------------------------------------- R. Scott Immuno/Biochem Tech. 183,166 - - -------------------------------------------------------------------------------------------------------------- L. Radler Immuno/Biochem Tech. 150,306 - - -------------------------------------------------------------------------------------------------------------- J. Burgensob Immuno/Biochem Tech. 184,296 - - -------------------------------------------------------------------------------------------------------------- S. Gormley Sm. Animal Care Tech. 109,107 - - -------------------------------------------------------------------------------------------------------------- 0. Saine Sm. Animal Care Tech. 97,098 - - -------------------------------------------------------------------------------------------------------------- L. Denenno Quality Assurance 17,692 - - -------------------------------------------------------------------------------------------------------------- Medical Center Director Labor Cost Total 2,822,291 - - -------------------------------------------------------------------------------------------------------------- DIRECT LABOR Research Blvd. Cost Center - - -------------------------------------------------------------------------------------------------------------- T. Moskal DVM Veterinarian 47,627 - - -------------------------------------------------------------------------------------------------------------- S. Harbauch BIO/TOX Technician 123,811 - - -------------------------------------------------------------------------------------------------------------- M. Sowers BIO/TOX Technician 86,060 ==============================================================================================================
NIH 2706 (5/92) Page 2 of 4
==================================================================================================================================== NATIONAL INSTITUTES OF HEALTH PROJECT TITLE: "BIOLOGICAL TESTING FACILITY" FINANCIAL REPORT OF INDIVIDUAL PROJECT/CONTRACT - - ------------------------------------------------------------------------------------------------------------------------------------ NOTE: COMPLETE THIS FORM IN ACCORDANCE REPORTING PERIOD WITH ACCOMPANYING INSTRUCTIONS. - - ------------------------------------------------------------------------------------------------------------------------------------ LABOR HOURS CUMULATIVE EXPENDITURE CATEGORY INCURRED COST INCURRED CUMULATIVE AT END OF COST-CURRENT COST TO DATE NEGOTIATED ACTUAL PRIOR PERIOD PERIOD (D+E) - - ------------------------------------------------------------------------------------------------------------------------------------ A B C D E F ==================================================================================================================================== E. Jarvis Nonhuman Primare Care Tech. 11,880 - - ------------------------------------------------------------------------------------------------------------------------------------ Research Blvd. Direct Labor Care Total 23,350 - - ------------------------------------------------------------------------------------------------------------------------------------ - - ------------------------------------------------------------------------------------------------------------------------------------ TOTAL DIRECT LABOR 150,110 - - ------------------------------------------------------------------------------------------------------------------------------------ - - ------------------------------------------------------------------------------------------------------------------------------------ B. FRINGE BENEFITS - - ------------------------------------------------------------------------------------------------------------------------------------ Med Center @ 41% - - ------------------------------------------------------------------------------------------------------------------------------------ Research Blvd. @ 41% - - ------------------------------------------------------------------------------------------------------------------------------------ - - ------------------------------------------------------------------------------------------------------------------------------------ TOTAL FRINGE BENEFITS - - ------------------------------------------------------------------------------------------------------------------------------------ - - ------------------------------------------------------------------------------------------------------------------------------------ TOTAL DIRECT COSTS - - ------------------------------------------------------------------------------------------------------------------------------------ - - ------------------------------------------------------------------------------------------------------------------------------------ C. OVERHEAD - - ------------------------------------------------------------------------------------------------------------------------------------ Med Center @ 99% (DL+FR) - - ------------------------------------------------------------------------------------------------------------------------------------ Research Blvd. @ 153% (DL+FR) - - ------------------------------------------------------------------------------------------------------------------------------------ TOTAL OVERHEAD - - ------------------------------------------------------------------------------------------------------------------------------------ - - ------------------------------------------------------------------------------------------------------------------------------------ D. MATERIALS & SUPPLIES - - ------------------------------------------------------------------------------------------------------------------------------------ Food & Bedding - - ------------------------------------------------------------------------------------------------------------------------------------ Syringes, Needles, Inst. ====================================================================================================================================
=============================================================================================================== CONTRACT NO.: NO1-HD-6-3259 DATE OF REPORT: - - --------------------------------------------------------------------------------------------------------------- CONTRACTOR NAME AND ADDRESS: BIOQUAL, Inc. 9600 Medical Center Drive ROCKVILLE, MD 20850-3300 - - --------------------------------------------------------------------------------------------------------------- ESTIMATED VARIANCE EXPENDITURE CATEGORY ESTIMATED COST AT NEGOTIATED (OVER OR COST TO COMPLETION CONTRACT UNDER) COMPLETE (F+G) AMOUNT (I-H - - --------------------------------------------------------------------------------------------------------------- G H I J =============================================================================================================== E. Jarvis Nonhuman Primare Care Tech. 137,564 - - --------------------------------------------------------------------------------------------------------------- Research Blvd. Direct Labor Care Total 395,061 - - --------------------------------------------------------------------------------------------------------------- - - --------------------------------------------------------------------------------------------------------------- TOTAL DIRECT LABOR 3,217,353 - - --------------------------------------------------------------------------------------------------------------- - - --------------------------------------------------------------------------------------------------------------- B. FRINGE BENEFITS - - --------------------------------------------------------------------------------------------------------------- Med Center @ 41% 1,157,139 - - --------------------------------------------------------------------------------------------------------------- Research Blvd. @ 41% 161,975 - - --------------------------------------------------------------------------------------------------------------- TOTAL FRINGE BENEFITS 1,319,115 - - --------------------------------------------------------------------------------------------------------------- - - --------------------------------------------------------------------------------------------------------------- TOTAL DIRECT COSTS 4,536,467 - - --------------------------------------------------------------------------------------------------------------- - - --------------------------------------------------------------------------------------------------------------- C. OVERHEAD - - --------------------------------------------------------------------------------------------------------------- Med Center @ 99% (DL+FR) 3,939,637 - - --------------------------------------------------------------------------------------------------------------- Research Blvd. @ 153% (DL+FR) 852,265 - - --------------------------------------------------------------------------------------------------------------- TOTAL OVERHEAD 4,791,902 - - --------------------------------------------------------------------------------------------------------------- - - --------------------------------------------------------------------------------------------------------------- D. MATERIALS & SUPPLIES - - --------------------------------------------------------------------------------------------------------------- Food & Bedding 10,725 - - --------------------------------------------------------------------------------------------------------------- Syringes, Needles, Inst. 42,900 ===============================================================================================================
NIH 2706 (5/92) Page 3 of 4
==================================================================================================================================== NATIONAL INSTITUTES OF HEALTH PROJECT TITLE: "BIOLOGICAL TESTING FACILITY" FINANCIAL REPORT OF INDIVIDUAL PROJECT/CONTRACT - - ------------------------------------------------------------------------------------------------------------------------------------ NOTE: COMPLETE THIS FORM IN ACCORDANCE REPORTING PERIOD WITH ACCOMPANYING INSTRUCTIONS. - - ------------------------------------------------------------------------------------------------------------------------------------ LABOR HOURS CUMULATIVE EXPENDITURE CATEGORY INCURRED COST INCURRED CUMULATIVE AT END OF COST-CURRENT COST TO DATE NEGOTIATED ACTUAL PRIOR PERIOD PERIOD (D+E) - - ------------------------------------------------------------------------------------------------------------------------------------ A B C D E F ==================================================================================================================================== Glassware/Vialsn Primare Care Tech. - - ------------------------------------------------------------------------------------------------------------------------------------ Chemicals & Reagents - - ------------------------------------------------------------------------------------------------------------------------------------ Histology/Photography - - ------------------------------------------------------------------------------------------------------------------------------------ RIA - - ------------------------------------------------------------------------------------------------------------------------------------ Clinical Chem - - ------------------------------------------------------------------------------------------------------------------------------------ Cleaning/Prot Cloth - - ------------------------------------------------------------------------------------------------------------------------------------ Disposable Lab Supplies - - ------------------------------------------------------------------------------------------------------------------------------------ TOTAL MATERIALS & SUPPLIES - - ------------------------------------------------------------------------------------------------------------------------------------ - - ------------------------------------------------------------------------------------------------------------------------------------ E. OTHER DIRECT COSTS - - ------------------------------------------------------------------------------------------------------------------------------------ Transportation - - ------------------------------------------------------------------------------------------------------------------------------------ Animals - - ------------------------------------------------------------------------------------------------------------------------------------ Overtime Premium - - ------------------------------------------------------------------------------------------------------------------------------------ Consultants/Contractors Pathology - - ------------------------------------------------------------------------------------------------------------------------------------ Clinical Chemistry - - ------------------------------------------------------------------------------------------------------------------------------------ Toxicology - - ------------------------------------------------------------------------------------------------------------------------------------ Equipment & Warranties - - ------------------------------------------------------------------------------------------------------------------------------------ TOTAL OTHER DIRECT COSTS - - ------------------------------------------------------------------------------------------------------------------------------------ - - ------------------------------------------------------------------------------------------------------------------------------------ ====================================================================================================================================
============================================================================================================== CONTRACT NO.: NO1-HD-6-3259 DATE OF REPORT: - - -------------------------------------------------------------------------------------------------------------- CONTRACTOR NAME AND ADDRESS: BIOQUAL, Inc. 9600 Medical Center Drive ROCKVILLE, MD 20850-3300 - - -------------------------------------------------------------------------------------------------------------- ESTIMATED VARIANCE EXPENDITURE CATEGORY ESTIMATED COST AT NEGOTIATED (OVER OR COST TO COMPLETION CONTRACT UNDER) COMPLETE (F+G) AMOUNT (I-H - - -------------------------------------------------------------------------------------------------------------- A G H I J ============================================================================================================== Glassware/Vialsn Primare Care Tech. 32,175 - - -------------------------------------------------------------------------------------------------------------- Chemicals & Reagents 21,460 - - -------------------------------------------------------------------------------------------------------------- Histology/Photography 21,450 - - -------------------------------------------------------------------------------------------------------------- RIA 241,311 - - -------------------------------------------------------------------------------------------------------------- Clinical Chem 10,725 - - -------------------------------------------------------------------------------------------------------------- Cleaning/Prot Cloth 80,437 - - -------------------------------------------------------------------------------------------------------------- Disposable Lab Supplies 85,799 - - -------------------------------------------------------------------------------------------------------------- TOTAL MATERIALS & SUPPLIES 546,972 - - -------------------------------------------------------------------------------------------------------------- - - -------------------------------------------------------------------------------------------------------------- E. OTHER DIRECT COSTS - - -------------------------------------------------------------------------------------------------------------- Transportation 2,500 - - -------------------------------------------------------------------------------------------------------------- Animals 500,000 - - -------------------------------------------------------------------------------------------------------------- Overtime Premium 54,662 - - -------------------------------------------------------------------------------------------------------------- Consultants/Contractors Pathology 50,000 - - -------------------------------------------------------------------------------------------------------------- Clinical Chemistry 15,000 - - -------------------------------------------------------------------------------------------------------------- Toxicology 1,000,000 - - -------------------------------------------------------------------------------------------------------------- Equipment & Warranties 75,000 - - -------------------------------------------------------------------------------------------------------------- TOTAL OTHER DIRECT COSTS 1,697,162 - - -------------------------------------------------------------------------------------------------------------- - - -------------------------------------------------------------------------------------------------------------- - - --------------------------------------------------------------------------------------------------------------
NIH 2706 (5/92) Page 4 of 4
==================================================================================================================================== NATIONAL INSTITUTES OF HEALTH PROJECT TITLE: "BIOLOGICAL TESTING FACILITY" FINANCIAL REPORT OF INDIVIDUAL PROJECT/CONTRACT - - ------------------------------------------------------------------------------------------------------------------------------------ NOTE: COMPLETE THIS FORM IN ACCORDANCE REPORTING PERIOD WITH ACCOMPANYING INSTRUCTIONS. - - ------------------------------------------------------------------------------------------------------------------------------------ LABOR HOURS CUMULATIVE EXPENDITURE CATEGORY INCURRED COST INCURRED CUMULATIVE AT END OF COST-CURRENT COST TO DATE NEGOTIATED ACTUAL PRIOR PERIOD PERIOD (D+E) - - ------------------------------------------------------------------------------------------------------------------------------------ A B C D E F ==================================================================================================================================== F. G&A BASE - - ------------------------------------------------------------------------------------------------------------------------------------ G&A @ 22.4% - - ------------------------------------------------------------------------------------------------------------------------------------ TOTAL COSTS - - ------------------------------------------------------------------------------------------------------------------------------------ - - ------------------------------------------------------------------------------------------------------------------------------------ G. FEE - - ------------------------------------------------------------------------------------------------------------------------------------ TOTAL COSTS PLUS FIXED FEE - - ------------------------------------------------------------------------------------------------------------------------------------ - - ------------------------------------------------------------------------------------------------------------------------------------ - - ------------------------------------------------------------------------------------------------------------------------------------ - - ------------------------------------------------------------------------------------------------------------------------------------ - - ------------------------------------------------------------------------------------------------------------------------------------ - - ------------------------------------------------------------------------------------------------------------------------------------ - - ------------------------------------------------------------------------------------------------------------------------------------ - - ------------------------------------------------------------------------------------------------------------------------------------ - - ------------------------------------------------------------------------------------------------------------------------------------ - - ------------------------------------------------------------------------------------------------------------------------------------ - - ------------------------------------------------------------------------------------------------------------------------------------ - - ------------------------------------------------------------------------------------------------------------------------------------ - - ------------------------------------------------------------------------------------------------------------------------------------ - - ------------------------------------------------------------------------------------------------------------------------------------ ====================================================================================================================================
============================================================================================================== CONTRACT NO.: NO1-HD-6-3259 DATE OF REPORT: - - -------------------------------------------------------------------------------------------------------------- CONTRACTOR NAME AND ADDRESS: BIOQUAL, Inc. 9600 Medical Center Drive ROCKVILLE, MD 20850-3300 - - -------------------------------------------------------------------------------------------------------------- ESTIMATED VARIANCE EXPENDITURE CATEGORY ESTIMATED COST AT NEGOTIATED (OVER OR COST TO COMPLETION CONTRACT UNDER) COMPLETE (F+G) AMOUNT (I-H - - -------------------------------------------------------------------------------------------------------------- G H I J ============================================================================================================== F. G&A BASE 11,572,502 - - -------------------------------------------------------------------------------------------------------------- G&A @ 22.4% 2,592,240 - - -------------------------------------------------------------------------------------------------------------- TOTAL COSTS 14,164,742 - - -------------------------------------------------------------------------------------------------------------- - - -------------------------------------------------------------------------------------------------------------- G. FEE 851,149 - - -------------------------------------------------------------------------------------------------------------- TOTAL COSTS PLUS FIXED FEE 15,015,891 - - -------------------------------------------------------------------------------------------------------------- - - -------------------------------------------------------------------------------------------------------------- - - -------------------------------------------------------------------------------------------------------------- - - -------------------------------------------------------------------------------------------------------------- - - -------------------------------------------------------------------------------------------------------------- - - -------------------------------------------------------------------------------------------------------------- - - -------------------------------------------------------------------------------------------------------------- - - -------------------------------------------------------------------------------------------------------------- - - -------------------------------------------------------------------------------------------------------------- - - -------------------------------------------------------------------------------------------------------------- - - -------------------------------------------------------------------------------------------------------------- - - -------------------------------------------------------------------------------------------------------------- - - -------------------------------------------------------------------------------------------------------------- - - -------------------------------------------------------------------------------------------------------------- ==============================================================================================================
NIH 2706 (5/92) (6) INPATIENT CARE. Costs associated with a subject while occupying a bed in a patient care setting. It normally includes both routine and ancillary costs. (7) OUTPATIENT CARE. Costs associated with a subject while not occupying a bed. It normally includes ancillary costs only. (8) TRAVEL. Includes all direct costs of travel, including transportation, subsistence and miscellaneous expenses. Travel for staff and consultants shall be shown separately. Identify foreign and domestic travel separately. If required by the contract, the following information shall be submitted: (i) Name of traveler and purpose of trip: (ii) Place of departure, destination and return, including time and dates; and (iii) Total cost of trip. (9) CONSULTANT FEE. Fees paid to consultant. Identify each consultant with effort expended billing rate and amount billed. (10) PREMIUM PAY. Includes the amount of salaries and wages over and above the basic rate of pay. (11) SUBCONTRACTS. List each subcontract by name and amount billed. (12) OTHER COSTS. Includes a number of separate expenditure categories for which the Government does not require individual line item reporting. It may include some of the above categories. (13) OVERHEAD/INDIRECT COSTS. Identify the cost base indirect cost rate and amount billed for each indirect cost category. (14) GENERAL AND ADMINISTRATIVE EXPENSE. Cite the rate and the base. In the case of nonprofit organizations, this item will usually be included in the indirect cost. (15) FEE. If any cite the fee earned. (16) TOTAL COSTS TO THE GOVERNMENT. PREPARATION INSTRUCTIONS These instructions are keyed to the columns on Form NIH 2706. COLUMN A--EXPENDITURE CATEGORY. Enter in column A the expenditure categories required by the contract. COLUMN B--PERCENTAGE OF EFFORT/HOURS FUNDED. Enter in column B the percentage of effort or number of hours agreed to during contract negotiations for each labor category listed in column A. COLUMN C--PERCENTAGE OF EFFORT/HOURS-ACTUAL. The Contractor will enter the cumulative percentage of effort or number of hours worked by each employee or group of employees listed in Column A. COLUMN D--CUMULATIVE INCURRED COST AT END OF PRIOR PERIOD. This column should show the cumulative incurred costs up to the end of the prior reporting period. This column will be blank at the time of the submission of the initial report. COLUMN E--INCURRED COST-CURRENT PERIOD. The Contractor should enter the costs which were incurred during the current period. COLUMN F--CUMULATIVE INCURRED COST TO DATE. The Contractor should enter the combined total of Columns D and E. COLUMN G--ESTIMATED COST TO COMPLETE. Entries need only be made when the Contractor estimates that a particular expenditure category will vary from the amount funded. Realistic estimates are essential. COLUMN H--ESTIMATED COSTS AT COMPLETION. No entry is required in this column unless an entry is made in Column G. COLUMN I -- FUNDED CONTRACT AMOUNT. Enter in this column the costs agreed to during contract negotiations for all expenditure categories listed in Column A. COLUMN J - VARIANCE (OVER OR UNDER). This column need not be filled in when Column H is blank. When entries have been made in Column H this column should show the difference between the estimated costs at completion (Column H) and funded costs (Column I). When a line item varies by plus or minus 10%, i.e., the percentage arrived at by dividing Column J by Column I, an explanation of the variance should be submitted. In the case of an overrun (net negative variance), this submission shall not be deemed as notice under the Limitation of Cost (Funds) clause of the contract. MODIFICATIONS. Any modification in the amount funded for an item since the preceding report should be listed in the appropriate cost category. EXPENDITURES NOT FUNDED. An expenditure for an item for which no amount was funded (e.g., at the discretion of the Contractor in performance of its contract) should be listed in the appropriate cost category and all columns filled in except for I. Column J will of course show a 100% variance and will be explained along with those identified under J above. Attachment J.1.d INVOICE/FINANCING REQUEST INSTRUCTION FOR NIH COST-REIMBURSEMENT TYPE CONTRACTS GENERAL: The contractor shall submit claims for reimbursement in the manner and format described herein and as illustrated in the sample invoice/financing requests. FORMAT: Standard Form 1034, "Public Voucher for Purchases and Services Other Than Personal"; and Standard Form 1035, "Public Voucher for Purchase and Services Other Than Personal -- Continuation Sheet", or reproduced copies of such forms marked ORIGINAL should be used to submit claims for reimbursement. In lieu of SF-1034 and SF-1035, claims may be submitted on the payee's letter-head or self-designed form provided that it contains the information shown on the sample invoice/fancing request. NUMBER OF COPIES: As indicated in the Invoice Submission clause in the contract. FREQUENCY: Invoices/financing requests submitted in accordance with the payment clause shall be submitted monthly unless otherwise authorized by the contracting officers. COST INCURRENCE PERIOD: Costs incurred must be within the contract performance period or covered by precontract cost provisions. BILLING OF COSTS INCURRED: If billed costs include: (1) Costs of a prior billing period, but not previously billed, or (2) costs incurred during the contract period and claimed after the contract period has expired, the amount and month(s) in which such costs were incurred shall be cited. CONTRACTOR'S FISCAL YEAR: Invoice/financing requests shall be prepared in such a manner that costs claimed can be identified with the contractor's fiscal year. CURRENCY: All NIH contracts are expressed in United States dollars. Where expenditures are made in a currency other than United States dollars, billings on the contract shall be expressed, and reimbursement by the United States Government shall be made, in that other currency at amounts coincident which actual costs incurred. Currency fluctuations may not be a basis of gain or loss to the contractor. Notwithstanding the above, the total of all invoices paid under this contract may not exceed the United States dollars authorized. COSTS REQUIRING PRIOR APPROVAL: Costs requiring the contracting officer's approval which are not set forth in an advance understanding in the contract shall be so identified and reference the Contracting Officer's Authorization (COA) number. INVOICE/FINANCING REQUEST IDENTIFICATION: Each invoice/financing request shall be identified as either: (a) INTERIM INVOICE/CONTRACT FINANCING REQUEST - There are interim payment requests submitted during the contract performance period. (b) COMPLETION INVOICE - The completion invoice is a final invoice which is submitted promptly upon completion of the work, but no later than one year from the contract completion date. The completion invoice should be submitted when all costs (except for finalization of indirect cost rates) have been assigned to the contract and all performance provisions have been completed. (c) FINAL INVOICE - A revised final invoice may be required after the amounts owed have been settled between the government and the Contractor (e.g., final indirect cost rates and resolution of all suspensions and audit exceptions). PREPARATION AND ITEMIZATION OF THE INVOICE/FINANCING REQUEST: The Contractor shall furnish the information set forth in the explanatory notes below. These notes are keyed to the entries on the sample invoice/financing request. (a) PAYOR'S NAME AND ADDRESS - The paying office and address, identified in the Invoice Submission clause of the contract, shall be entered on all copies of the invoice/financing request. (b) INVOICE/FINANCING REQUEST NUMBER - Insert the appropriate serial number of the invoice/financing request. (c) DATE INVOICE/FINANCING REQUEST PREPARED - Insert the date the invoice/financing request is prepared. (d) CONTRACT NUMBER AND DATEUP - Insert the contract number and the date of the contract. (e) PAYEE'S NAME AND ADDRESS - Show the Contractor's name (as it appears in the contract), correct address, and the title and phone number of the responsible official to whom payment is to be sent. When an approved assignment has been made by the contractor, or a different payee has been designated, then insert the name and address of the payee instead of the contractor. (f) TOTAL ESTIMATED COST OF CONTRACT - Insert the total estimated cost of the contract, exclusive of fixed-fee. For incrementally funded contracts, enter the amount currently obligated and available for payment. (g) TOTAL FIXED-FEE - Insert the total fixed-fee (where applicable). (h) BILLING PERIOD - Insert the beginning and ending dates (month, day, and year) of the period in which costs were incurred and for which reimbursement is claimed. (i) AMOUNT BILLED FOR CURRENT PERIOD - Insert the amount billed for the major cost element, adjustments, and adjusted amounts for the period. (j) CUMULATIVE AMOUNT FROM INCEPTION TO DATE OF THIS BILLING - Insert the cumulative amounts billed for the major cost elements and adjusted amounts claimed during this contract. (k) DIRECT COSTS - Insert the major cost elements. For each element, consider the application of the paragraph entitled "Costs Requiring Prior Approval" on page 1 of these instructions. (1) DIRECT LABOR - This consists of salaries and wages paid (or accrued) for direct performance of the contract. (2) FRINGE BENEFITS This represents fringe benefits applicable to direct labor and billed as a direct cost. Fringe benefits included in indirect costs should not be identified here. (3) ACCOUNTABLE PERSONAL PROPERTY - This category of cost includes permanent research equipment and general purpose equipment having a unit acquisition cost of $1,000 or more and having an expected service life of more than two years, and sensitive property regardless of cost (see the DHHS Contractor's Guide for Control of Government Property). Show permanent research equipment separate from general purpose equipment. Prepare and attach Form HHS-565, "Report of Accountable Property", in accordance with the following instructions: List each item for which reimbursement is requested. A reference shall be made to the following (as applicable): (A) The item number for the specific piece of equipment listed in the Property Schedule; (B) The Contracting Officer's Authorization letter and number, if the equipment is not covered by the Property Schedule, or; (C) Be preceded by an asterisk (*) if the equipment is below the approval level. Further itemization of invoices/financing requests shall only be required for items having specific limitations set forth in the contract. (4) MATERIALS AND SUPPLIES - This category includes equipment with unit costs of less than $1,000 or an expected service life of two years or less, and consumable material and supplies regardless of amount. (5) PREMIUM PAY - This is remuneration in excess of the basic hourly rate. (6) CONSULTANT FEE - Fees paid to consultants. Identify consultant by name or category as set forth in the contract's advance understanding or in the COA letter, as well as the effort (i.e., number of hours, days, etc.) and rate being billed. (7) TRAVEL - Foreign travel is travel outside of Canada, the United States and its territories and possessions. However, for an organization located outside Canada, United States and its territories and possessions, foreign travel means travel outside that country. Foreign travel should be billed separately from domestic travel. (8) SUBCONTRACT COSTS - List subcontractor(s) by name and amount billed. (9) OTHER - List all other direct costs in total unless exceeding $1,000 in amount. If over $1,000 list cost elements and dollar amounts separately. If the contract contains restrictions on any cost element, that cost element should be listed separately. (l) COST OF MONEY (COM) - Cite the COM factor and base in effect during the time the cost was incurred and for which reimbursement is claimed. (m) INDIRECT COSTS - OVERHEAD - Identify the cost base, indirect cost rate, and amount billed for each indirect cost category. (n) FIXED-FEE EARNED - If the contract provides for a fixed-fee, it must be claimed as provided for by the contract. Cite the formula or method of computation. (o) TOTAL AMOUNTS CLAIMED - Insert the total amounts claimed for the current and cumulative periods. (p) ADJUSTMENTS - This includes amounts conceded by the contractor, outstanding suspensions, and disapprovals subject to appeal. (q) GRAND TOTALS THE CONTRACTING OFFICER MAY REQUIRE THE CONTRACTOR TO SUBMIT DETAILED SUPPORT FOR COSTS CLAIMED ON ONE OR MORE INTERIM INVOICES/FINANCING REQUESTS. SAMPLE INVOICE/FINANCING REQUEST (a) Payor's Name and Address (b) Invoice/Financing Request No. NATIONAL INSTITUTES OF HEALTH Division of Financial Management -------------------------------- Contracts Section, FAAB Building 31, Room B1B05A -------------------------------- Bethesda, Maryland 20892 (c) Date Invoice Prepared -------------------------------- (e) Payee's Name and Address (d) Contract No. and Date ABC CORPORATION 100 Main Street -------------------------------- Anywhere, U.S.A. zip code (f) Total Estimated Cost of Contract -------------------------------- (g) Total Fixed Fee Attention: Name, Title, and Phone Number of Official to Whom Payment is Sent
- - ------------------------------------------------------------------------------- (h) This invoice/financing request represents reimbursable costs from August 1, 1982 through August 31, 1982. - - -------------------------------------------------------------------------------
(i) Amount Billed (j) Cumulative for Current Amount From Period Inception to Date of this Billing --------------------- ------------------ (k) Direct Costs (1) Direct Labor (2) Fringe Benefits $ 3,400 $ 6,800 (3) Accountable Personal Property 600 1,200 (Attach Form HHS-565) Permanent Research 3,000 8,000 General Purpose 2,000 (4) Materials and Supplies 2,000 4,000 (5) Premium Pay (6) Consultent Fee - 100 150 Dr. Jones 1 day @ 100 (COA #3) (7) Travel (Domestic) 100 100 (Foreign) 200 200 (8) Subcontract Costs 200 200 (9) Other -0- -0- Total Direct Costs -0- -0- ------- ------- 11,600 20,650 (l) Cost of Money (Factor) of (appropriate Base) 2.400 3.600 (m) Indirect Costs -- Overhead _____% of Direct Labor or Other Base (Formula) 4,000 6.000 (n) Fixed-Fee Earned (Formula) 700 1.400 (o) Total Amount Claimed $18,700 $31,650 (p) Adjustments Outstanding Suspensions (1,700) ------- ------- (q) Grand Totals $18,700 $29,950
" I certify that all payments requested are for appropriate purposes and in accordance with the contract." - - ----------------------------------- ---------------------------------- Name of Official Title Attachment J.1.e This clause is for use in all cost-reimbursement RFP's and contracts. The clause will be modified for use in fixed-price contracts. PROCUREMENT OF CERTAIN EQUIPMENT Notwithstanding any other clause in this contract, the contractor will not be reimbursed for the purchase, lease, or rental of any item of equipment listed in the following Federal Supply Groups, regardless of the dollar value, without the prior written approval of the contracting officer. 67 - Photographic Equipment 69 - Training Aids and Devices 70 - General Purpose ADP Equipment, Software, Supplies and Support (Excluding 7045-ADP Supplies and Support Equipment.) 71 - Furniture 72 - Household and Commercial Furnishings and Appliances 74 - Office Machines and Visible Record Equipment 77 - Musical Instruments, Phonographs, and Home-type Radios 78 - Recreational and Athletic Equipment When equipment in these Federal Supply Groups is requested by the contractor and determined essential by the contracting officer, the Government will endeavor to fulfill the requirement with equipment available from its excess personal property sources, provided the request is made under a cost-reimbursement contract. Extension or renewals of approved existing leases or rentals for equipment in these Federal Supply Groups are excluded from the provisions of this article. Attachment J.1.f Schedule II-A GOVERNMENT FURNISHED PROPERTY (Ref. Section G.7) The following government property will be transferred from contract number NO1-HD-1-3130 to be used on this project.
Quantity Description 1 Beckman Gamma Counter, 60 Hz, with printer 1 Beckman centrifuge 1 Beckman rotor (Rack Instrument) J6B 1 Beckman Refrigerator Accessory J6B 1 Beckman Liquid Scintillation Counter 1 Beckman Random Coincidence Monitor LS7000 1 Beckman Liquid Scintillation Counter with printer 1 Beckman External Standardization LS1800 1 Beckman Two-Phase Monitor LS1800 1 Beckman Multi-use Accessory LS1800 1 Beckman Sample Changer LS 1800 1 Beckman Refrigerated Centrifuge with rotor 1 SUN Laser Printer 1 SUN 141 MB Disk Subsystem 1 SUN 3/60 Desktop Workstation 1 SUN B & W Monitor 8 Cages, rabbit, stainless steel 1 Nikon Labophot-2 Microscope 1 Bockel Industries Economy Incubator 1 LabLine Titer Plate Shaker 1 Brinkman 8-channel Pipettor 1 Lab. Counter Differential Counter 1 Dynatech Microplate Reader with printer 1 Dynatech Handiwash Plate Washer 1 Packard Instruments Automatic Gamma Counter 19 Cages, primate, mobile 52 Adult male and female rhesus monkeys
NO1-HD-6-3259 Section K PART IV - REPRESENTATIONS AND INSTRUCTIONS SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS ------------------------------------------------------- K.1 REPRESENTATIONS AND CERTIFICATIONS (NIH 3115) (JUN 1986) The following document(s) are incorporated by reference in this contract. 1. The Representations, Certifications and other Statements of Offerors dated December 6, 1995 and submitted in anticipation of contract award by the contractor are hereby incorporated by reference into this contract. K-1

Basic Info X:

Name: (10) Government Contracts
Type: Government Contracts
Date: Aug. 28, 1996
Company: BIOQUAL INC
State: Delaware

Other info:

Date:

  • FY 97
  • FY 99
  • June 30 , 1997
  • September 1 , 1996
  • June 30 , 2001
  • July 1 , 1996
  • August 31 , 1996
  • December 1 , 1990
  • June 1 , 1991
  • December 1 , 1989
  • August 1 , 1982
  • August 31 , 1982
  • December 6 , 1995

Organization:

  • # # # # OMB
  • NICHD National Institutes of Health
  • ] Contracts Management Branch
  • KEY PERSONNEL NIH
  • Total Cost Name Rate Number of Hours
  • Section F. c. Pathology
  • Section F. d.
  • Federal Acquisition Regulations FAR
  • Financial Advisory Services Branch Division of Contracts
  • National Institutes of Health Office of Financial Management Chief
  • Contract Accounting Branch
  • Contract Property Administrator G-3
  • NO1-HD-6-3259 Section G Research Contracts Property Administration
  • Department of Health and Human Services
  • Fiscal Year Dollar Amount of Salary Limitation
  • Office of Protection
  • Research Risks OPRR
  • Public Health Service Policy on Humane Care
  • Use of Laboratory Animals
  • Animal Welfare Assurance
  • the National Institutes of Health
  • the National Institute of Child Health and Human Development
  • Contract Number NO1-HD-6-3259
  • NIH Cost-Reimbursement Type Contracts NIH
  • Certain Equipment OMB
  • Office of Federal Procurement Policy Act
  • Certificate of Procurement Integrity
  • c. Financial Report of Individual 592 6 ProjectContract
  • e. Procurement of Certain 484 1 Equipment
  • Required Objectives and Desired Results
  • Contraceptive Development Branch
  • Food and Drug Administration
  • Administration of Test Materials A. Precautions Contractor
  • F. Selection of Dose Levels 1
  • G. Drug Delivery Systems
  • b. Assay c. Duration
  • Thymolytic b. Glycogenic c. NaK excretion d. Anti-inflammatory 9
  • BUN Calcium ion Chloride Sodium Potassium Creatinine Direct bilirubin GGTP Glucose Iron LDH Magnesium Inorganic phosphate SGOT SGPT Total bilirubin Total
  • Glucose Ketones Bilirubin Hemoglobin Nitrite Urobilinogen
  • Hematocrit Hemoglobin Erythrocyte Count Leucocyte Count Reticulocyte Count Platelet Count Differential Count Mean Corpuscular Volume Mean Corpuscular Hemoglobin
  • NICHD 2 FinalSummary National Institutes of Health 5 GLP
  • Contracting Officer 1 Quarterly Contracts Management Branch
  • NICHD 1 FinalSummary National Institutes of Health 1 GLP
  • E. Jarvis Nonhuman Primare Care Tech
  • Direct Labor Care Total
  • GlasswareVialsn Primare Care Tech
  • Standard Form 1034
  • Standard Form 1035
  • United States Government
  • DHHS Contractor 's Guide for Control of Government Property
  • HEALTH Division of Financial Management
  • Phone Number of Official
  • Current Amount From Period Inception
  • General Purpose ADP Equipment
  • Federal Supply Groups
  • Beckman Liquid Scintillation Counter 1 Beckman Random Coincidence Monitor LS7000 1 Beckman Liquid Scintillation Counter
  • Nikon Labophot-2 Microscope 1 Bockel Industries Economy Incubator 1 LabLine Titer Plate Shaker 1 Brinkman
  • Dynatech Microplate Reader
  • Dynatech Handiwash Plate Washer 1 Packard Instruments

Location:

  • AMERICA
  • Rockville Pike Bethesda
  • Helly
  • Needles
  • Canada
  • United States
  • Maryland

Money:

  • # #
  • $ 15,015,891.00
  • $ 14,164,742.00
  • $ 851,149.00
  • $ 73Hr* 64 $ 5,000
  • $ 15,000
  • $ 45,000
  • $ 2,793,568.00
  • $ 2,636,131.00
  • $ 157,437.00
  • $ .00
  • $ 465,595.00
  • $ 2,636,131 $ 157,437 $ 2,793,568
  • $ 14,164,742 $ 851,149 $ 15,015,891
  • $ 125,000
  • $ 54,662
  • $ 1,000
  • $ 3,400 $ 6,800
  • $ 18,700 $ 31,650
  • $ 18,700 $ 29,950

Person:

  • F. M. Garner
  • Jerry R. Reel
  • Sheri Hild-Petito
  • Janice M. Larner
  • B. Antifertility
  • E. Radioimmunoassay
  • Richard P. Blye
  • Paul J. Duska
  • J. Reel
  • S. Hild-Petito
  • J. Larner
  • D. Gropp
  • S. Propst
  • E. Curreri
  • R. Scott ImmunoBiochem Tech
  • L. Radler ImmunoBiochem Tech
  • J. Burgensob ImmunoBiochem Tech
  • S. Gormley
  • T. Moskal
  • M. Sowers
  • Beckman Gamma Counter

Percent:

  • 90 %
  • 110 %
  • 500 %
  • 300 %
  • 200 %
  • 12 %
  • 25 %
  • 20 %
  • 50 %
  • 0.4 %
  • 0.5 %
  • 0.9 %
  • 41 %
  • 99 %
  • 153 %
  • 22.4 %
  • 100 %