EXHIBITS
--------
(10) Government Contracts.
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2. Title: Care and Housing of AIDS
Research Animals.
Institute: National Institute of
Allergy and Infectious
Diseases
Dates Funded: 2/1/00 - 1/31/07
STANDARD FORM 26 (REV. 4-85) NSN 7540-01-152-8069 OMB No. 0990-0115 RFP 99-56
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AWARD/CONTRACT 1. THIS CONTRACT IS A RATED ORDER RATING PAGE OF PAGES
UNDER DPAS (15 CFR 350) 1 17
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2. CONTRACT (Proc. inst. ident.) No. 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQUEST/PROJECT NO.
N01-AO-02734 See Item 20C. 001971
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5. ISSUED BY CODE 2668-02733 6. ADMINISTERED BY (If other than item 5) CODE
National Institutes of Health
Acquisitions Mgmt. Operations Branch
Room 1130
6700-B Rockledge Dr., MSC 7605
Bethesda, Maryland 20892-7605
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7. NAME AND ADDRESS OF CONTRACTOR (No., street, city, country, State and ZIP Code) 8. DELIVERY
Bioqual, Inc [ ] FOB ORIGIN [x] OTHER (See below)
9600 Medical Center Drive -------------------------------------------
Rockville, MD 20850-3336 9. DISCOUNT FOR PROMPT PAYMENT
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10. SUBMIT INVOICES ITEM
(4 copies unless other-
wise specified) TO THE 5.
- ---------------------------------------------------------------------------------------- ADDRESS SHOWN IN
CODE FACILITY CODE
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11. SHIP TO/MARK FOR 12. PAYMENT WILL BE MADE BY CODE
See Sect. F, Article F.2. See Article G.3.
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13. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION 14. ACCOUNTING AND APPROPRIATION DATA
N/A DOC# N1AO02734; OC 25.2E
CAN# 08325797, Amount Allotted $1,376,137
[ ] 10 U.S.C. 2304 (c)( ) [ ] 41 U.S.C. 253(c)( ) EIN# 1133078199A2
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15A. ITEM NO. 15B. SUPPLIES/SERVICES 15C. QUANTITY 15D. UNIT 15E. UNIT PRICE 15F. AMOUNT
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Research & Development Contract
Title: Care and Housing of AIDS Research Animals
Period: February 1, 2000 through January 31, 2007
Amount allotted: $1,376,137
Contract Type: CPFF - Completion
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15G. TOTAL AMOUNT OF CONTRACT $10,798,411
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16. TABLE OF CONTENTS
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(x) SEC. DESCRIPTION PAGE(S) (x) SEC. DESCRIPTION PAGE(S)
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PART I - THE SCHEDULE PART II - CONTRACT CLAUSES
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x A SOLICITATION/CONTRACT FORM 1 x I CONTRACT CLAUSES 11
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x B SUPPLIES OR SERVICES AND PRICES/COSTS 3 PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH
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x C DESCRIPTION/SPECS./WORK STATEMENT 4 x J LIST OF ATTACHMENTS 16
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x D PACKAGING AND MARKING 5 PART IV - REPRESENTATIONS AND INSTRUCTIONS
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x E INSPECTION AND ACCEPTANCE 5
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x F DELIVERIES OR PERFORMANCE 6 OTHER STATEMENTS OF OFFERORS
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x G CONTRACT ADMINISTRATION DATA 7 L INSTRS., CONDS., AND NOTICES TO OFFERORS
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x H SPECIAL CONTRACT REQUIREMENTS 9 M EVALUATION FACTORS FOR AWARD
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CONTRACTING OFFICER WILL COMPLETE ITEM 17 OR 18 AS APPLICABLE
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17. [x] CONTRACTOR'S NEGOTIATED AGREEMENT (Contractor is re- 18. [ ] AWARD (Contractor is not required to sign this
quired to sign this document and return 3 copies document.) Your offer on Solicitation Number
--- ------------------ including the full additions or changes
to issuing office.) Contractor agrees to furnish and deliver made by you which additions or changes are set forth in full
all items or perform all the services set forth or otherwise above, is hereby accepted as to the items listed above and on
identified above and on any continuation sheets for the any continuation sheets. This award consummates the contract
consideration stated herein. The rights and obligations of the which consists of the following documents: (a) the Government's
parties to this contract shall be subject to and governed by solicitation and your offer, and (b) this award/contract. No
the following documents: (a) this award/contract, (b) the further contractual document is necessary.
solicitation, if any, and (c) such provisions, representations,
certifications, and specifications, as are attached or incorp-
orated by reference herein. (Attachments are listed herein.)
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19A. NAME AND TITLE OF SIGNER (Type or print) 20A. NAME OF CONTRACTING OFFICER
/s/ Michael P. O'Flaherty COO Karin E. Eddy
Contracting Officer
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19B. NAME OF CONTRACTOR 19C. DATE SIGNED 20B. UNITED STATES OF AMERICA 20C. DATE SIGNED
BY /s/ Michael P. O'Flaherty BY /s/ Karin E. Eddy
--------------------------------------- 1/28/00 --------------------------------------- 1/28/2000
(Signature of person authorized to sign) (Signature of Contracting Officer)
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DETAILED TABLE OF CONTRACT CONTENTS
PART I - THE SCHEDULE
SECTION A - SOLICITATION/CONTRACT FORM............................................... 1
SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS.................................... 3
Article B.1. Brief Description of Supplies or Services............................ 3
Article B.2. Estimated Cost and Fixed Fee......................................... 3
Article B.3. Provisions Applicable to Direct Costs................................ 3
Article B.4. Advanced Understandings.............................................. 4
SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT................................ 4
Article C.1. Statement of Work.................................................... 4
Article C.2. Reporting Requirements............................................... 5
SECTION D - PACKAGING, MARKING AND SHIPPING.......................................... 5
SECTION E - INSPECTION AND ACCEPTANCE................................................ 5
SECTION F - DELIVERIES OR PERFORMANCE................................................ 6
Article F.1. Period of Performance................................................ 6
Article F.2. Deliveries........................................................... 6
Article F.3. Clauses Incorporated by Reference.................................... 7
SECTION G - CONTRACT ADMINISTRATION DATA............................................. 7
Article G.1. Project Officer...................................................... 7
Article.G.2. Key Personnel........................................................ 7
Article G.3. Invoice Submission/Contract Financing Request and Financial Report... 8
Article G.4. Indirect Costs Rates................................................. 8
Article G.5. Government Property.................................................. 8
Article G.6. Post Award Evaluation of Past Performance............................ 9
SECTION H - SPECIAL CONTRACT REQUIREMENTS............................................ 9
Article H.1. Reimbursement of Costs for Independent Research and Development...... 9
Article H.2. Needle Exchange...................................................... 9
Article H.3. Animal Welfare Assurance............................................. 9
Article H.4. Press Releases....................................................... 10
Article H.5. Reporting Matters Involving Fraud, Waste and Abuse................... 10
PART II - CONTRACT CLAUSES............................................................. 11
SECTION I - CONTRACT CLAUSES......................................................... 11
Article I.1. General Clauses for a Cost Reimbursement Service Contract............ 11
Article I.2. Authorized Substitutions of Clauses.................................. 13
Article I.3. Additional Contract Clauses.......................................... 14
Article I.4. Additional FAR Contract Clauses Included in Full Text................ 15
PART III LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS............................. 16
SECTION J - LIST OF ATTACHMENTS...................................................... 16
PART IV REPRESENTATIONS AND INSTRUCTIONS............................................... 17
SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS
OF OFFERER........................................................................... 17
2
SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS
ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES
The contractor shall house, feed and care for an estimated 200 nonhuman
primates, including but not limited to the following species: Macaca mulatta,
Macaca nemestrina, Cercopithecus aethiops, and any other combination of Old
World and New World species. In addition, the contractor shall conduct up to 10
procedures per year with each animal consisting of 4 to 12 nonhuman primates
using one or more viruses, and collect and deliver specimens ordered by the
NIAID Project Officer. The contractor shall conduct procedures in accordance
with individual NIAID protocols. Specimens collected by the Contractor will be
used by NIAID scientists to conduct experiments and specialized tests. The
nature of investigations being conducted by NIAID scientists using simian
immunodeficiency viruses require long-term, overlapping, labor intensive studies
which will necessitate that the contractor maintain individual animals for
periods longer than 12 months.
ARTICLE B.2. ESTIMATED COST AND FIXED FEE
a. The estimated cost of this contract is $10,045,034.
b. The fixed fee for this contract is $753,377. The fixed fee shall be paid in
installments based on the percentage of completion of work, as determined
by the Contracting Officer, and subject to the withholding provisions of
the clauses ALLOWABLE COST AND PAYMENT and FIXED FEE referenced in the
General Clause Listing in Part II, ARTICLE I.1. of this contract. Payment
of fixed fee shall not be made in less than monthly increments.
c. The Government's obligation, represented by the sum of the estimated cost
plus the fixed fee for this contract is $10,798,411.
d. Total funds currently available for payment and allotted to this contract
are $1,376,137 of which $1,280,127 represents the estimated costs, and of
which $96,010 represents the fixed fee. For further provisions on funding,
see the LIMITATION OF FUNDS clause referenced in Part II, ARTICLE I.2.
Authorized Substitutions of Clauses.
e. It is estimated that the amount currently allotted will cover performance
of the contract through January 31, 2001.
f. The Contracting Officer may allot additional funds to the contract without
the concurrence of the Contractor.
ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS
a. Items Unallowable Unless Otherwise Provided
Notwithstanding the clauses, ALLOWABLE COST AND PAYMENT and FIXED FEE,
incorporated in this contract by reference, 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.);
(4) Travel to attend general scientific meetings;
(5) Domestic Travel
(6) Foreign travel;
(7) Consultant Costs
3
(8) Subcontracts
(9) Patient care costs;
(10) Accountable Government property (defined as both real and personal
property with an acquisition 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. Transportation Costs
(1) Total expenditures for transportation incurred in direct performance of
this contract shall not exceed $54,127 without the prior written
approval of the Contracting Officer.
(2) Total expenditures for Premium (overtime) Pay incurred in direct
performance of this contract shall not exceed $90,399 without the prior
written approval of the Contracting Officer.
ARTICLE B.4. ADVANCE UNDERSTANDINGS
Other provisions of this contract notwithstanding, approval of the following
items within the limits set forth is hereby granted without further
authorization from the Contracting Officer.
(1) As stated in the Federal Register, Volume 57, No. 190, page 45096, dated
September 30, 1992, Policy Letter on Inherently Government Functions, no
personal services shall be performed under this contract. All work
requirements shall flow only from the Project Officer to the Contractor's
Project Manager. No Contractor employee will be directly supervised by the
Government. All individual employee assignments, and daily work direction,
shall be given by the applicable employee supervisor. If the Contractor
believes any Government action or communication has been given that would
create a personal services relationship between the Government and any
Contractor employee, the Contractor shall promptly notify the Contracting
Officer of this communication or action.
(2) The contractor agrees to immediately notify the contracting officer in
writing if there is an anticipated overrun (any amount) or unexpended
balance (greater than 10 percent) of the amount allotted to the contract,
and the reasons for the variance. Also refer to the requirements of the
Limitation of Funds and Limitation of Costs Clauses in the contract.
(3) The contractor may charge directly to this contract an equal monthly amount
for the depreciation of each Animal Enclosure (cage) use for this project,
not to exceed a ten (10) year recovery period from the date the enclosure
was first placed in service. The contractor shall add Enclosure
refurbishing costs to its overhead pool.
(4) Fringe Benefits, Overhead and G&A rates, as proposed in Bioqual,
Incorporated Final Revised Offer, dated December 13, 1999, are accepted for
proposal purposes only. The Government will not approve reimbursements
based on these proposed rates until such time as a new rate agreement has
been negotiated and approved by the cognizant Contracting Officer, in
accordance with ARTICLE G.4., INDIRECT COST RATES.
SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT
ARTICLE C.1. STATEMENT OF WORK
a. Independently and not as an agent of the Government, the Contractor shall
be required to 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 (see SECTION J,
ATTACHMENT 1, dated 4/2/99), attached hereto and made a part if this
contract.
4
ARTICLE C.2. REPORTING REQUIREMENTS
a. Technical Progress Reports
In addition to the reports required by the other terms of this contract, the
Contractor shall prepare and submit the following reports in the manner
stated below and in accordance with Article F.1. Deliveries of this contract:
(1) Monthly Progress Report - 2 copies
This report shall include a description of the activities during the
reporting period, and the activities planned for the ensuing reporting
period. The first reporting period consists of the first full month of
performance plus any fractional part of the initial month. Thereafter
the reporting period shall consist of each calendar month.
(2) Final Report - 6 copies
This report is to include a summation of the work performed and results
obtained for the entire contract period of performance. This report
shall be in sufficient detail to describe comprehensively the results
achieved. The Final Report shall be submitted in accordance with Article
F.1. Deliveries of this contract.
(3) Summary of Salient Results
The Contractor shall submit, with the final report, a summary (not to
exceed 200 words) of salient results achieved during the performance of
the contract. This report will be required on or before the expiration
date of the contract.
SECTION D - PACKAGING, MARKING AND SHIPPING
Clinical and pathological specimens designated by the Project Officer will be
collected and delivered intact, within 2 hours of being drawn from the animal
but no later than 11:00 A.M. on the day obtained. All deliverables required
under this contract shall be packaged, marked and shipped in accordance with
Government specifications. At a minimum, all deliverables shall be marked with
the contract number and contractor name. The Contractor shall guarantee that
all required materials shall be delivered in immediate usable and acceptable
condition.
ARTICLE D.1. PACKAGING
Blood samples are to be shipped at room temperature in a cardboard container.
Frozen samples are to be shipped on dry ice in a styrofoam container.
Occasionally, biopsies are shipped on wet ice in styrofoam.
ARTICLE D.2. SHIPPING
All specimens shall be shipped f.o.b. destination to the following address:
Project Officer
Laboratory of Molecular Microbiology, NIAID
Twinbrook II Facility, Room 221
12441 Parklawn Drive
Rockville, MD 20852
SECTION E - INSPECTION AND ACCEPTANCE
a. The Contracting Officer or the duly authorized representative will perform
inspection and acceptance of materials and services to be provided.
b. For the purpose of this ARTICLE, the Project Officer is the authorized
representative of the Contracting Officer.
c. Inspection and acceptance will be performed at:
Laboratory of Molecular Microbiology, NIAID
Twinbrook II Facility, Room 221
12441 Parklawn Drive
Rockville, MD 20852
5
Acceptance may be presumed unless otherwise indicated in writing by the
Contracting Officer or the duly authorized representative within 30 days of
receipt.
d. This contract incorporates the following clause by reference, with the same
force and effect as if it were given in full text. Upon request, the
Contracting Officer will make its full text available.
FAR Clause 52.246-5, INSPECTION OF SERVICES-COST REIMBUSRSEMENT (APRIL 1984).
SECTION F - DELIVERIES OR PERFORMANCE
ARTICLE F.1. PERIOD OF PERFORMANCE
The period of performance of this contract shall be from February 1, 2000
through January 31, 2007.
ARTICLE F.2. DELIVERIES
a. Satisfactory performance of this contract shall be deemed to occur upon
delivery and acceptance by the Contracting Officer, or the duly authorized
representative, of the services specified in ARTICLE C.1., Statement of Work.
b. The items specified below as described in SECTION C. ARTICLE C.2. will be
required to be delivered F.O.B. Destination as set forth in FAR 52.247-35,
F.O.B. DESTINATION, WITHIN CONSIGNEE'S PREMISES (APRIL 1984), and in
accordance with and by the date(s) specified below:
Item Quantity Delivery Schedule
---- -------- -----------------
a) Monthly Reports 2 10 Days after end of Month
b) Final Report and Summary of 6 15 Days after end of Contract
Salient Results
c. The above items shall be addressed and delivered to:
Addressee Deliverable Item No. Quantity
---------- -------------------- --------
Project Officer, LMM,NIAID (a) 1
Twinbrook II Facility, Room 221 (b) 4
MSC 460
Bethesda, MD 20892
Ivan Hernandez, Contracts (a) 1
Specialist, NIAID, NIH (b) 2
6700-B Rockledge Dr., Rm. 1127
Bethesda, MD 20892-7605
6
d. Deliveries of animal specimens required by the contractor shall be made
f.o.b. destination as set forth in FAR 52.247-35, F.O.B. DESTINATION, WITHIN
CONSIGNEES PREMISES (APRIL 1984) and in conformance with the specifications
stated in SECTION D, PACKAGING, MARKING AND SHIPPING, of this contract, to
the address/addressee listed below:
DELIVERY POINT:
Laboratory of Molecular Microbiology, NIAID
Twinbrook II Facility, Room 221
12441 Parklawn Drive
Rockville, MD 20852
e. Unless otherwise specified elsewhere in this solicitation, deliveries shall
be made to the Delivery Point specified above Mondays through Fridays
(excluding Federal Holidays) between the hours of 8:30 a.m. and 11:00 a.m.
only. Supplies or services scheduled for delivery on a Federal holiday shall
be made the next following workday.
ARTICLE F.3. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY 1998)
This contract incorporates the following clause by reference, with the same
force and effect as if it were given in full text. Upon request, the
Contracting Officer will make its full text available. Also, the full text of a
clause may be accessed electronically at this address:
http://www.arnet.gov/far/.
FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:
52.242-15, Stop Work Order (AUGUST 1989) with ALTERNATE I (APRIL 1984).
SECTION G - CONTRACT ADMINISTRATION DATA
ARTICLE G.1. PROJECT OFFICER
The following Project Officer(s) will represent the Government for the purpose
of this contract: Dr. Vanessa Hirsch
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 acceptances required by this contract; and (5)
assisting in the resolution of technical problems encountered during
performance.
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.
ARTICLE G.2. KEY PERSONNEL
Pursuant to the Key Personnel clause incorporated in this contract, the
following individual(s) is/are considered to be essential to the work being
performed hereunder:
NAME TITLE
---- -----
Dr. Richard Bradbury Principal Investigator
Dr. Marissa Cook St. Claire Veterinarian
Dr. Boris Skopets Veterinarian
7
ARTICLE G.3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND FINANCIAL REPORT
a. Invoice/Financing Request Instructions and Contract Financial Reporting for
NIH Cost-Reimbursement Type Contracts NIH(RC)-1 are attached and made part of
this contract. The instructions and the following directions for the
submission of invoices/financing request must be followed to meet the
requirements of a "proper" payment request pursuant to FAR 32.9.
These instructions also provide for the submission of financial and personnel
reporting required by HHSAR 342.7002.
(1) Invoices/financing requests shall be submitted concurrently as follows:
An original and two copies to the following designated billing office:
Ivan Hernandez
Contract Specialist
Acquisitions Management and Operations Branch
National Institute of Allergy and Infectious Diseases
National Institutes of Health
Room 1127, 6700-B Rockledge Drive
BETHESDA MD 20892-7605
(2) Inquiries regarding payment of invoices should be directed to the
designated billing office, Office of Financial Management, NIH, Tel.
(301) 496-6452.
ARTICLE G.4. INDIRECT COST RATES
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 Part II, Section I, the cognizant Contracting Officer
responsible for negotiating provisional and/or final indirect cost rates is
identified as follows:
Director, Division of Financial Advisory Services
Office of Contract Management
National Institutes of Health
6100 Building, Room 6B05
6100 EXECUTIVE BLVD MSC 7540
BETHESDA MD 20892-7540
These rates are hereby incorporated without further action of the Contracting
Officer.
ARTICLE G.5. GOVERNMENT PROPERTY
a. In addition to the requirements of the clause, GOVERNMENT PROPERTY,
incorporated in Section I of this contract, the Contractor shall comply with
the provisions of 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 and
inventory and reporting requirements under the contract. A copy of this
publication is available upon request to the Contract Property Administrator.
This contract's Contract Property Administrator is:
Charles Varga
Contracts Property Administrator
Research Contracts Property Administration, NIH
6011 Building, Room 641E
6011EXECUTIVE BLVD MSC 7670
BETHESDA MD 20892-7670
(301) 496-6466
b. Government Furnished Property - Schedule II-A
8
Pursuant to the clause, GOVERNMENT PROPERTY, incorporated in this contract,
the Contractor is hereby authorized to retain custody of the property listed
in 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. N01-AO-52703, under which these
items were provided by the Government. Title to this property shall remain
in the Government.
ARTICLE G.6. POST AWARD EVALUATION OF PAST PERFORMANCE
Interim and final evaluations of contractor performance will be prepared on this
contract in accordance with FAR 42.15. The final performance evaluation will be
prepared at the time of completion of work. In addition to the final
evaluation, interim evaluations will be prepared annually to coincide with the
anniversary date of the contract.
Interim and final evaluations will be provided to the Contractor as soon as
practicable after completion of the evaluation. The Contractor will be
permitted thirty days to review the document and to submit additional
information or a rebutting statement. Any disagreement between the parties
regarding an evaluation will be referred to an individual one level above the
Contracting Officer, whose decision will be final.
Copies of the evaluations, contractor responses, and review comments, if any,
will be retained as part of the contract file, and may be used to support future
award decisions.
SECTION H - SPECIAL CONTRACT REQUIREMENTS
ARTICLE H.l. REIMBURSEMENT OF COSTS FOR INDEPENDENT RESEARCH AND DEVELOPMENT
PROJECTS (Commercials Only)
The primary purpose of the Public Health Service (PHS) is to support and advance
independent research within the scientific community. This support is provided
in the form of contracts and grants totaling approximately 7 billion dollars
annually. PHS has established effective, time tested and well recognized
procedures for stimulating and supporting this independent research by selecting
from multitudes of applications those research projects most worthy of support
within the constraints of its appropriations. The reimbursement through the
indirect cost mechanism of independent research and development costs not
incidental to product improvement would circumvent this competitive process.
To ensure that all research and development projects receive similar and equal
consideration, all organizations may compete for direct funding of independent
research and development projects they consider worthy of support by submitting
those projects to the appropriate Public Health Service grant office for review.
Since these projects may be submitted for direct funding, the Contractor agrees
that no costs for any independent research and development project, including
all applicable indirect costs, will be claimed under this contract.
ARTICLE H.2. NEEDLE EXCHANGE
a. Pursuant to Public Law(s) cited in paragraph b., below, contract funds shall
not be used to carry out any program of distributing sterile needles or
syringes for the hypodermic injection of any illegal drug.
b. Public Law and Section No. Fiscal Year Period Covered
106-113 Section 505 FY 00 10/01/99 - 9/30/00
ARTICLE H.3. ANIMAL WELFARE ASSURANCE
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.
9
ARTICLE H.4. PRESS RELEASES
a. Pursuant to Public Law(s) sited in paragraph b., below, the contractor shall
clearly state, when issuing statements, press releases, requests for
proposals, bid solicitations and other documents describing projects or
programs funded in whole or in part with Federal money: (1) the percentage of
the total costs of the program or project which will be financed with Federal
money; (2) the dollar amount of Federal funds for the project or program; and
(3) the percentage and dollar amount of the total costs of the project or
program that will be financed by nongovernmental sources.
b. Public Law and Section No. Fiscal Year Period Covered
106-113 Section 507 FY 00 10/01/99 - 9/30/00
ARTICLE H.5. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE
Anyone who becomes aware of the existence or apparent existence of fraud, waste
and abuse in NIH funded programs is encouraged to report such matters to the
DHHS Inspector General's Office in writing or on the Inspector General's
Hotline. The toll free number is 1-800-DHHS-TIPS (1-800-447-8477). All
telephone calls will be handled confidentially. The e-mail address is
Htips@os.dhhs.gov and the mailing address is:
Office of Inspector General
Department of Health and Human Services
TIPS HOTLINE
P.O. Box 23489
Washington, D.C. 20026
Information regarding procedural matters is contained in the NIH Manual Chapter
1754, which is available on (http://www1.od.nih.gov/oma/oma.htm)
10
PART II - CONTRACT CLAUSES
SECTION I - CONTRACT CLAUSES
ARTICLE I.1. GENERAL CLAUSES FOR A COST-REIMBURSEMENT SERVICE CONTRACT - CLAUSES
INCORPORATED BY REFERENCE (FEBRUARY 1998)
This contract incorporates the following 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. Also, the full text of
a clause may be accessed electronically at this address:
http://www.arnet.gov/far/.
a. FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES:
FAR
CLAUSE
NO. DATE TITLE
------ ---- -----
52.202-1 Oct 1995 Definitions
52.203-3 Apr 1984 Gratuities (Over $100,000)
52.203-5 Apr 1984 Covenant Against Contingent Fees (Over $100,000)
52.203-6 Jul 1995 Restrictions on Subcontractor Sales to the Government (Over $100,000)
52.203-7 Jul 1995 Anti-Kickback Procedures (Over $100, 000)
52.203-8 Jan 1997 Cancellation, Rescission, and Recovery of Funds for Illegal or Improper Activity (Over
$100,000)
52.203-10 Jan 1997 Price or Fee Adjustment for Illegal or Improper Activity (Over $100,000)
52.203-12 Jun 1997 Limitation on Payments to Influence Certain Federal Transactions (Over $100,000)
52.204-4 Jun 1996 Printing/Copying Double-Sided on Recycled Paper (Over $100,000)
52.209-6 Jul 1995 Protecting the Government's Interests when Subcontracting with Contractors Debarred,
Suspended, or Proposed for Debarment (Over $25,000)
52.215-2 Jun 1999 Audit and Records - Negotiation (Over $100,000)
52.215-8 Oct 1997 Order of Precedence - Uniform Contract Format
52.215-10 Oct 1997 Price Reduction for Defective Cost or Pricing Data
52.215-12 Oct 1997 Subcontractor Cost or Pricing Data (Over $500,000)
52.215-14 Oct 1997 Integrity of Unit Prices (Over $100,000)
52.215-15 Dec 1998 Pension Adjustment and Asset Reversion
52.215-18 Oct 1997 Reversion or Adjustment of Plans for Post-Retirement Benefits (PRB) other than Pensions
52.215-19 Oct 1997 Notification of Ownership Changes
52.215-21 Oct 1997 Requirements for Cost or Pricing Data or Information Other Than Cost of Pricing Data -
Modifications
52.216-7 Apr 1998 Allowable Cost and Payment
11
52.216-8 Mar 1997 Fixed Fee
52.219-8 Oct 1999 Utilization of Small Business Concerns
52.219-9 Oct 1999 Small Business Subcontracting Plan (Over $500,000)
52.219-16 Jan 1999 Liquidated Damages - Subcontracting Plan (Over $500,000)
52.222-2 Jul 1990 Payment for Overtime Premium (Over $100,000) (NOTE: The dollar amount in paragraph (a) of
this clause is $0 unless otherwise specified in the contract.)
52.222-3 Aug 1996 Convict Labor
52.222-26 Feb 1999 Equal Opportunity
52.222-35 Apr 1998 Affirmative Action for Disabled and Vietnam Era Veterans
52.222-36 Jun 1998 Affirmative Action for Workers with Disabilities
52.222-37 Jan 1999 Employment Reports on Disabled Veterans and Veterans of the Vietnam Era
52.223-2 Apr 1984 Clean Air and Water (Over $100,000)
52.223-6 Jan 1997 Drug Free Workplace
52.223-14 Oct 1996 Toxic Chemical Release Reporting
52.225-11 Aug 1998 Restrictions on Certain Foreign Purchases
52.227-1 Jul 1995 Authorization and Consent
52.227-2 Aug 1996 Notice and Assistance Regarding Patent and Copyright Infringement (Over $100,000)
52.227-3 Apr 1984 Patent Indemnity
52.227-14 Jun 1987 Rights in Data - General
52.232-9 Apr 1984 Limitation on Withholding of Payments
52.232-17 Jun 1996 Interest (Over $100,000)
52.232-20 Apr 1984 Limitation of Cost
52.232-23 Jan 1986 Assignment of Claims
52.232-25 Jun 1997 Prompt Payment
52.232-34 May 1999 Payment by Electronic Funds Transfer--Other Than Central Contractor Registration
52.233-1 Dec 1998 Disputes
52.233-3 Aug 1996 Protest After Award, Alternate I
52.242-1 Apr 1984 Notice of Intent to Disallow Costs
52.242-3 Oct 1995 Penalties for Unallowable Costs (Over $500,000)
52.242-4 Jan 1997 Certification of Final Indirect Costs
52.242-13 Jul 1995 Bankruptcy (Over $100,000)
52.243-2 Aug 1987 Changes - Cost Reimbursement, Alternate I (Apr 1984)
12
52.244-2 Aug 1998 Subcontracts, Alternate II (Aug 1998) *If written consent to subcontract is required, the
identified subcontracts are listed in ARTICLE B, Advance Understandings of the contract.
52.244-5 Dec 1996 Competition in Subcontracting (Over $100,000)
52.245-5 Jan 1986 Government Property (Cost-Reimbursement, Time and Material, or Labor-Hour Contract)
52.246-25 Feb 1997 Limitation of Liability - Services (Over $100,000)
52.249-6 Sep 1996 Termination (Cost-Reimbursement)
52.249-14 Apr 1984 Excusable Delays
52.253-1 Jan 1991 Computer Generated Forms
b. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48
CFR CHAPTER 3) CLAUSES.
HHSAR
CLAUSE
------
NO. DATE TITLE
------ ---- -----
352.202-1 Apr 1984 Definitions - Alternate I (Apr 1984)
352.228-7 Dec 1991 Insurance - Liability to Third Persons
352.232-9 Apr 1984 Withholding of Contract Payments
352.233-70 Apr 1984 Litigation and Claims
352.242-71 Apr 1984 Final Decisions on Audit Findings
352.270-5 Apr 1984 Key Personnel
352.270-6 Jul 1991 Publication and Publicity
352.270-7 Apr 1984 Paperwork Reduction Act
[End of GENERAL CLAUSES FOR A COST-REIMBURSEMENT SERVICE CONTRACT - Rev.
5/1999].
ARTICLE I.2 AUTHORIZED SUBSTITUTION OF CLAUSES
ARTICLE I.1. of this SECTION is hereby modified as follows:
FAR 52.215-14, INTEGRITY OF UNIT PRICES (OCTOBER 1999) is deleted in its
entirety.
FAR 52.219-9, SMALL BUSINESS SUBCONTRACTOR PLAN (OCTOBER 1999) and FAR Clause
52.219-16, LIQUIDATED DAMAGES--SUBCONTRACING PLAN (JANUARY 1999) are deleted in
their entirety.
FAR 52.232-20, LIMITATION OF COST, is deleted in its entirety and FAR 52.232-22,
LIMITATION OF FUNDS (APRIL 1984) is substituted therefor.
13
ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES
This contract incorporates the following clauses by reference, (unless otherwise
noted) 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.
a. FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES
a. FAR 52.217-2, Cancellation Under Multiyear Contract (July 1996).
b. FAR 52.219-6, Notice of Total Small Business Set-Aside (July 1996).
c. FAR 52.219-14, Limitation on Subcontracting (Dec 1996)
d. FAR 52.223-3, Hazardous Material Identification and Material Safety Data
(JANUARY 1997), ALTERNATE I (JULY 1995)
e. FAR 52.227-17, Rights in Data--Special Works (JUNE 1987).
f. FAR 52.237-3, Continuity of Services (JANUARY 1991).
g. FAR 52.246-25, Limitation of Liability (FEBRUARY 1997).
b. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION/PUBLIC HEALTH
SERVICE ACQUISITION REGULATION (HHSAR)/(PHSAR) (48 CHAPTER 3) CLAUSES:
1) PHS 352.223-70, Safety and Health (Deviation) (AUGUST 1997).
2) PHS 352.280-2b, Care of Live Vertebrate Animals (OCTOBER 1986).
c. NATIONAL INSTITUTES OF HEALTH (NIH) RESEARCH CONTRACTING (RC) CLAUSES:
The following clauses are attached and made a part of this contract:
1) NIH (RC)-7, Procurement of Certain Equipment (APRIL 1984) (OMB Bulletin
81-16).
14
ARTICLE I.4. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT
This contract incorporates the following clauses in full text.
FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES:
a. FAR 52.244-6, SUBCONTRACTS FOR COMMERCIAL ITEMS AND COMMERCIAL COMPONENTS
(OCTOBER 1998)
(a) Definition.
Commercial item, as used in this clause, has the meaning contained in the
clause at 52.202-1, Definitions.
Subcontract, as used in this clause, includes a transfer of commercial
items between divisions, subsidiaries, or affiliates of the Contractor or
subcontractor at any tier.
(b) To the maximum extent practicable, the Contractor shall incorporate, and
require its subcontractors at all tiers to incorporate, commercial items
or nondevelopmental items as components of items to be supplied under
this contract.
(c) Notwithstanding any other clause of this contract, the Contractor is not
required to include any FAR provision or clause, other than those listed
below to the extent they are applicable and as may be required to
establish the reasonableness of prices under Part 15, in a subcontract at
any tier for commercial items or commercial components:
(1) 52.222-26, Equal Opportunity (E.O. 11246);
(2) 52.222-35, Affirmative Action for Special Disabled and Vietnam Era
Veterans (38 U.S.C. 4212(a));
(3) 52.222-36, Affirmative Action for Handicapped Workers (29 U.S.C. 793);
and
(4) 52.247-64, Preference for Privately Owned U.S.-Flagged Commercial
Vessels (46 U.S.C. 1241) (flow down not required for subcontracts
awarded beginning May 1, 1996).
(d) The Contractor shall include the terms of this clause, including this
paragraph (d), in subcontracts awarded under this contract.
15
PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS
SECTION J - LIST OF ATTACHMENTS
The following documents are attached and incorporated in this contract:
1. Statement of Work, April 5, 1999, 5 Pages
2. Invoice/Financing Request and Contract Financial Reporting Instructions for
NIH Cost-Reimbursement Type Contracts, NIH(RC)-4, May, 1997, 5 pages.
3. Safety and Health (Deviation), PHSAR Clause 352.223-70, August 1997, 1 page.
4. Procurement of Certain Equipment, NIH(RC)-7, (OMB Bulletin 81-16), April
1984, 1 page.
5. Government Property - Schedule II-A
16
PART IV
SECTION K - REPRESENTATIONS AND CERTIFICATIONS (Negotiated).
The following documents are incorporated by reference in this contract:
1. Representations and Certifications, dated September 20, 1999.
2. Certificate of Current Costs or Pricing Data (FAR 15.406-2), dated December
20, 1999.
3. Animal Welfare Assurance Number A3086-01.
17
STATEMENT OF WORK
Independently and not as an agent of the Government, the Contractor shall be
required to furnish all the necessary services, qualified personnel,
material, equipment, and facilities, not otherwise provided by the Government
as needed to perform the work set forth below.
The Contractor shall adhere to the following:
1 The institution must have the following credentials: a. AAALAC
International file number b. OPRR Animal Welfare Assurance number c. USDA
R Registration (Class "R" Research).
2 The facility in which the animals are housed shall be operated in
compliance with: a. The Animal Welfare Act (P.L. 89-544, as amended) Rules
and Regulations published in the Code of Federal Regulations (CFR), Title
9 (Animals and Animal Products), Chapter 1, Subchapter A (Animal Welfare),
Parts 1,2, and 3.b. Public Health Service (PHS) Policy on Humane Care and
Use of Laboratory Animals, updated 1996. c. The Guide for the Care and Use
of Laboratory Animals, revised 1996. d. NIH Manual 3040-3 Intramural
Contracts Involving Animals. e. Biosafety in Microbiological and
Biomedical Laboratories (CDC-NIH 1993). f. Occupational Health and Safety
in the Care and Use of Research Animals (NRC 1997). f. Guidelines for the
Prevention and Treatment of B-Virus Infections in Exposed Persons
(Clinical Infectious Diseases, 1995; 20: 421-439). h. New Ceropithecine
herpesvirus 1 (CHV-1) guidelines (to be established).
3 All nonhuman primates housed under this contract will be provided by the
Government.
4 All Animal Study Proposals for procedures that are to be performed on
NIAID owned animals will be prepared by the NIH, NIAID scientists and
submitted to the Contractor through the Project Officer or his/her
designee.
5 At the conclusion, the disposition of the animals shall be the
responsibility of the NIH, NIAID.
Specifically, the Contractor shall:
1 House, feed and care for an estimated 200 nonhuman primates including but
not limited to the following species: Macaca mulatta, Macaca nemestrina,
Cercopithecus, and any other combination of Old World and New World
species. Conduct up to 10 procedures per year with each experimental group
consisting of 4 to 12 nonhuman primates using one or more viruses. The
nature of investigations being conducted by the NIAID scientists using
simian immunodeficiency viruses require long-term, overlapping, labor
intensive studies which will necessitate that animals be maintained for
longer than 12 months post-inoculation. Procedures will be conducted
according to individual working protocols issued under NIAID ACUC approved
Animal Study Proposals. Viruses to be tested include, but shall not be
limited to, the following:
a. Various Simian Immunodeficiency Virus (SIV) strains.
b. SHIV
c. HIV
d. Vaccinia wild type and recombinant viruses
Statement of Work (4/2/99) ATTACHMENT 1
18
e. Attenuated and wild type adenoviruses, including recombinant
adenoviruses.
2 Perform procedures on nonhuman primates which shall include, but not be
limited to: inoculation (intravenous, intraperitoneal, subcutaneous,
intradermal, intracuscular, intravaginal, and intrarectal) of the animals
with various biological agents, monitoring animals for signs of disease,
evaluation of new therapies such as antiviral agents and immunotherapies
for their effectiveness against viral infection, and collection of
specimens as described by protocols furnished by the Project Officer. The
details of the specimen collection for electron microscopy and/or light
microscopy and virus isolation shall be detailed in each protocol or by
approved Standard Operating Procedures. During the disease course and at
termination of study, perform various clinical or pathological procedures
as needed or as requested by the Project Officer including but not limited
to:
a. Phlebotomy
b. Cerebrospinal Fluid Aspiration
c. Bone Marrow Aspiration
d. Peripheral Lymph Node Excisional Biopsy
e. Comprehensive Experimental Necropsy
f. Bronchoalceolar Lavage
g. Survival Surgery: Partial Splenic Resection, splenectomy, mesenteric
lymph node excisional biopsy, GALT excisional biopsy.
The Contractor shall perform final detailed, comprehensive necropsies as
specified by the Project Officer. Any special procedure conducted by the
Contractor shall be performed in accordance with the Project Officer's
specifications. Clinical and pathological specimens designated by the
Project Officer will be collected and delivered intact, within 2 hours of
being drawn from the animal but no later than 11:00 A.M. on the day
obtained, to NIAID Twinbrook II Facility in order to achieve optimal and
maximum virus isolation and recovery rates.
NOTE TO OFFERER: The performance of specialized tests on specimens collected
by the Contractor shall be the responsibility of the Government scientists.
3 Physical Plant:
a Biosafety Level: ABSL-2 practices, containment equipment, and facilities
are required for activities using non-human primates and small animals
experimentally infected with viruses in this 1. above and other latent
or intercurrent infections associated with these species.
b. Animal rooms: Provide the Project Officer separate rooms dedicated to
this contract (no commingling of animals from other projects) which are
environmentally controlled with non-recirculating air which is exchanged
10-15 times per hour. Negative air pressure relative to non-containment
areas shall be accomplished by an independent exhaust fan system.
c. Exhaust Air: Pass exhaust air through absolute HEPA filters. All
biocontainment modules will be attached directly to the building exhaust
system by flexible tubing. Al of the air exhausted from a room will be
drawn through cages when the room is fully fitted with the
biocontainment units. Air entering biocontainment units will pass
through a medium efficiency filter while the air leaving a unit will
move through the exhaust system and be HEPA filtered before exiting the
building. Back-up exhaust fans shall be used to insure operational
integrity of this system at all times.
Statement of Work (4/2/99)
19
d. Special Procedures Rooms: Provide suitable and separate rooms and
equipment consistent with the Guide for animal examination, necropsy,
surgery, surgical preparation, and radiography. The necropsy room will
contain workstations and a downdraft ventilation necropsy table which
meets OSHA and ASHRAE standards for exposure limits to formalin.
e. Storage Areas: Provide up to 500 square feet of secure floor and shelf
space for the storage of all equipment, supplies, and pharmaceutical
products. All pharmaceutical products (i.e., for treatment of
intercurrent infections, all tranquilizers, all analgesics), supplies
and equipment (i.e., for specimen collection, inoculation, biopsy,
surgery, necropsy, etc.), shall be specified by the Project Officer, and
supplied by the Contractor.
f. Alternative Power Supply: An emergency electric generator shall be
available to this project and available for immediate use in the event
of a loss of electric power.
g. Security: Provide a 24-hour security system and 24 hour security
personnel to prevent unauthorized entry. Restrict entrances into the
animal areas by locks and animal rooms shall display signs marked boldly
with the designation "Biohazard Area" on animal room doors. Signs shall
list the precautions necessary when entering the area(s) and entry shall
be limited to authorized personnel only.
4. Animal Environment, Housing, and Management:
a. Caging Specifications: The Contractor shall provide a combination of 6.0
Mobile Home Over/Under Modules and 6.0 Mobile Home Over/Under
Biocontainment Modules. These mobile modular cages are designed to allow
docking with adjacent cages and opening of transparent plexi-glass
shuttle doors to allow animal passage between adjacent cages thus
enhancing safety, security, efficiency, operational flexibility, and
attention to psychological well-being. This system permits and fosters
social housing of primates in accordance with the USDA/APHIS regulations
under the Animal Welfare Act and USPHS policy. The caging shall promote
the psychological well being of the animals while minimizing exposure to
infectious agents. The 6.0 Mobile Home Over/Under Biocontainment Modules
must be available if required for some immunodeficient animals.
b. HVAC: The Contractor shall use its best efforts to maintain 74-76
degrees F. and 15 air changes/hour.
c. Disinfection: Cages and isolation chambers shall be disinfected using a
chemical disinfectant/sterilant approved by the Project Officer. All
animal equipment (caging, feeders, etc.) shall be washed in a commercial
cage washer containing a suitable detergent at 180F. at least every two
weeks. Animal room floors shall be cleaned and sanitized with chemical
disinfectant daily. Micrbiological monitoring will be performed
quarterly using RODAC plates.
b. Medical Pathological Waste (MPW): The disposition of potentially
infected materials shall be accomplished, sequentially, in the following
manner:
Animal Room Waste: a. Liquids: sewage pipes, decontamination tanks at
210F. for 2 hours, public sewage system. b. Solids: double sealed bag,
sterilized, dumpster; (2) Animal Carcasses: Sealed bag, refrigerated,
necropsy, burn box, incinerator; (3) Specimens: sealed bag, in house
processing within Class II biological safety cabinet or sealed
centrifuge rotors; double bagged in plastic, labeled appropriately,
sealed outside container; delivered as directed; (4) Disposable Items:
a. Needles and Syringes: sharps container, autoclave as solid waste,
commercial biohazard waste disposal service. b. Other Disposables:
sealed bag, burn box, incinerator; and (5) Gowns: sealed bag, commercial
laundry service.
c. Environmental Enrichment: The Contractor shall provide plans for
enriching the environment of non-human primates.
20
d. Food: Provide appropriate diets of monkey chow and fresh fruit to non-
human primates. Fresh fruit (apples, oranges, bananas, etc.) shall be
fed, one per animal, daily. The protein content of Old World primate
diet shall be 15% and that of the New World primate diet shall be 25%.
Rations shall be fed at the rate of 1-3.5% of the animal's weight.
e. Identification and Records: Tattoo all animals across the chest with
identification numbers furnished by the Project Officer. Maintain
individual records for each animal in separate partition folders which
include the following: (1) The outside cover shall hold a Clinical and
Research Record form that includes the following information columns: a.
Immunizations; b. Parasite Control; c. Tuberculosis Tests; d. Weights
(Kg.); e. Clinical Procedures; f. Final Disposition; g Necropsy; (2)
Chronological Record of Medical Care; (3) Physical Examination Form; (4)
Food Consumption Form; (5) Hematology Results; (6) Serum Chemistry
Results; (7) Weight Charts; (8) Stool Condition Record; and (9)
Treatment Instructions. Implement a computer program for the entry of
records and/or data for location (Bldg./Rm.) complete animal
inventories, government furnished supply/material, equipment
inventories, clinical and pathological records, and other related
contract program management data. The computer program and data entry
shall be compatible for use with Mac/PC microcomputers and shall be
active within 3 months of contract award.
h. Animal Observation: Animals will be observed at least every 2 hours, 24
hours/day, 7 days/week.
NOTE TO CONTRACTOR: Proper maintenance of the Government-supplied equipment
shall be the responsibility of the Contractor. Repair to Government owned
equipment shall be provided by the Government.
3. Institutional Policies and Responsibilities:
a. Personnel Qualifications and Training: Personnel shall be specifically
trained and experienced in the care and maintenance of non-human
primates and other animals infected with the pathogens identified in
this Statement of Work.
b. Personal Protection: All personnel involved in the daily care of the
animals shall wear washable work clothing covered by a Tyvek laboratory
coat or washable/disposable surgeon's gown, disposable rubber gloves,
surgical face masks, scrub bonnets, protective eyewear/face shields, and
shoe covers or rubber boots. Personnel in contact with the monkeys
should be immunized, as available, for the viruses being studied.
c. Cross-Contamination: Because infectious agents are involved in these
studies, appropriate precautions shall be taken to prevent animal to
animal, animal to human, and human to animal transmission of viruses,
both endogenous and experimental, during all phases of the studies. New
pairs of disposable gloves and covers for workbenches shall be used for
each animal during collection of specimens. Clean/new protective barrier
clothing as specified in 5.b. above shall be worn every day and changed
when working with new animals on a different procedure. Separate sets of
sterile instruments shall be required for collection of each specimen.
d. Occupational Health and Safety of Personnel: Personnel will be enrolled
in a medical-surveillance program, including banking of their sera
(2ml), and maintain work practices consistent with the handling of
blood-borne pathogens (CDC 1988).
21
3. Veterinary Medical Care:
a. Surveillance, Diagnosis, Treatment, and Control of Disease: Ensure all
non-human primates are negative for SIV & SRV by serology and virus
isolation before introducing onto contract facilities. New non-human
primates shall be quarantined in a separate room or isolator and have 3
negative tuberculosis tests 15 days apart after introduction into the
facility and quarterly thereafter. Animals on contract will be weighed
and a comprehensive physical examination performed monthly, quarterly, or
semi-annually, or as specified in working protocols. A Complete Blood
Count and SMAC 24 shall be evaluated quarterly, as necessitated by the
animal's condition or as specified in working protocols.
b. Intercurrent Infections/Conditions: The treatment of intercurrent
infections and other conditions will first be discussed with the Project
Officer, and no medication, other than routine, shall be administered
without prior approval.
c. Euthanasia: The Project officer shall be notified of any untoward
findings in animals under this contract and prior approval shall be
obtained from the Project Officer before any animal is sacrificed.
22
INVOICE/FINANCING REQUEST AND CONTRACT FINANCIAL REPORTING
INSTRUCTIONS FOR NIH COST-REIMBURSEMENT CONTRACTS, NIH(RC)-4
General: The contractor shall submit claims for reimbursement in the manner and
format described herein and as illustrated in the sample invoice/financing
request.
Format: Standard Form 1034, "Public Voucher for Purchases and Services Other
Than Personal", and Standard Form 1035, "Public Voucher for Purchases 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/financing 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
officer.
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: Invoices/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. When
payments are made in a currency other than United States dollars, billings on
the contract shall be expressed, and payment by the United States Government
shall be made, in that other currency at amounts coincident with 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. In addition, any cost set forth in an Advance Understanding shall
be shown as a separate line item on the request.
Invoice/Financing Request Identification: Each invoice/financing request shall
be identified as either:
(a) Interim Invoice/Contract Financing Request - These are interim payment
requests submitted during the contract performance period.
(b) Completion Invoice - The completion invoice is submitted promptly upon
completion of the work; but no later than one year from the contract
completion date, or within 120 days after settlement of the final indirect
cost rates covering the year in which this contract is physically complete
(whichever date is later). The completion invoice should be submitted when
all costs have been assigned to the contract and all performance provisions
have been completed.
(c) Final Invoice - A final invoice may be required after the amounts owed have
been settled between the Government and the contractor (e.g., 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.
NIH(RC)-4 ATTACHMENT 2
Rev. 5/97
23
(a) Designated Billing Office Name and Address - Enter the designated billing
office and address, identified in the Invoice Submission Clause of the
contract, 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 Date - Insert the contract number and the effective date
of the contract.
(e) Payee's Name and Address - Show the contractors 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). For
incrementally funded contracts, enter the amount currently obligated and
available for payment.
(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) Incurred Cost - Current - Insert the amount billed for the major cost
elements, adjustments, and adjusted amounts for the current period.
(j) Incurred Cost - Cumulative - 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 - Include salaries and wages paid (or accrued) for direct
performance of the contract. For Key Personnel, list each employee on a
separate line. List other employees as one amount unless otherwise
required by the contract.
(2) Fringe Benefits - List any 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 - Include 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 Contractors 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):
- The item number for the specific piece of equipment listed in the
Property Schedule.
- The Contracting Officer's Authorization letter and number, if the
equipment is not covered by the Property Schedule.
- Be preceded by an asterisk (*) if the equipment is below the approval
level.
NIH(RC)-4 ATTACHMENT 2
Rev. 5/97
24
(4) Materials and Supplies - Include 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 - List remuneration in excess of the basic hourly rate.
(6) Consultant Fee - List 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 - Include domestic and foreign travel. Foreign travel is travel
outside of Canada, the United States and its territories and possessions.
However, for an organization located outside Canada, the United States and
its territories and possessions, foreign travel means travel outside that
country. Foreign travel must 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 must 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 - Cite the formula or method of computation for the fixed-
fee (if any). The fixed-fee must be claimed as provided for by the contract.
(o) Total Amounts Claimed - Insert the total amounts claimed for the current and
cumulative periods.
(p) Adjustments - Include amounts conceded by the contractor, outstanding
suspensions, and/or 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.
25
FINANCIAL REPORTING INSTRUCTIONS:
These instructions are keyed to the Columns on the sample invoice/financing
request.
Column A--Expenditure Category - Enter the expenditure categories required by
the contract.
Column B--Cumulative Percentage of Effort/Hrs.-Negotiated - Enter the percentage
of effort or number of hours agreed to doing contract negotiations for each
employee or labor category listed in Column A.
Column C--Cumulative Percentage of Effort/Hrs.-Actual - Enter the percentage of
effort or number of hours worked by each employee or labor category listed in
Column A.
Column D--Incurred Cost-Current - Enter the costs, which were incurred during
the current period.
Column E--incurred Cost-Cumulative - Enter the cumulative cost to date.
Column F--Cost at Completion - Enter data only when the contractor estimates
that a particular expenditure category will vary from the amount negotiated.
Realistic estimates are essential.
Column G--Contract Amount - Enter the costs agreed to during contract
negotiations for all expenditure categories listed in Column A.
Column H--Variance (Over or Under) - Show the difference between the estimated
costs at completion (Column F) and negotiated costs (Column G) when entries have
been made in Column F. This column need not be filled in when Column F is blank.
When a line item varies by plus or minus 10 percent, i.e., the percentage
arrived at by dividing Column F by Column G, 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 Clause of
the contract.
Modifications: Any modification in the amount negotiated for an item since the
preceding report should be listed in the appropriate cost category.
Expenditures Not Negotiated: An expenditure for an item for which no amount was
negotiated (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 G. Column H will of course show a 100 percent variance
along with those identified under H above.
NIH(RC)-4 ATTACHMENT 2
Rev. 5/97
26
SAMPLE INVOICE/FINANCING REQUEST AND CONTRACT FINANCIAL REPORT
=================================================================================================================================
(a) Billing Office Name and Address (b) Invoice/Financing Request No. __________________________________
Acquisition Management Operations Branch /C/ Date Invoice Prepared __________________________________________
National Institute of Allergy and infectious Diseases
6700-B Rockledge Drive, Room 1127 (d) Contract No. ___________________________________________________
MSC-7605
BETHESDA MD 20892-7605 Effective Date _________________________________________________
(e) Payee's Name and Address
ABC CORPORATION
100 Main Street (f) Total Estimated Cost ___________________________________________
Anywhere, USA zip code
(g) Total Fixed Fee ________________________________________________
Attn: Name, Title, & Phone Number of Official to Whom
Payment is Sent
=================================================================================================================================
(h) This invoice/financing request represents reimbursable costs for the period
from ___________ to ___________
=================================================================================================================================
Cumulative Percentage of
Effort/Hrs. Incurred Cost
-------------------------- ---------------------------- Cost at Contract
Expenditure Category* Negotiated Actual (I) Current (j) Cumulative Completion Amount Variance
A B C D E F G H
- ---------------------------------------------------------------------------------------------------------------------------------
(k) Direct Costs:
- ---------------------------------------------------------------------------------------------------------------------------------
(1) Direct Labor
- ---------------------------------------------------------------------------------------------------------------------------------
(2) Fringe Benefits
- ---------------------------------------------------------------------------------------------------------------------------------
(3) Accountable
Property (attach
DHHS-565)
- ---------------------------------------------------------------------------------------------------------------------------------
(4) Materials & Supplies
- ---------------------------------------------------------------------------------------------------------------------------------
(5) Premium Pay
- ---------------------------------------------------------------------------------------------------------------------------------
(6) Consultant Fees
- ---------------------------------------------------------------------------------------------------------------------------------
(7) Travel
- ---------------------------------------------------------------------------------------------------------------------------------
(8) Subcontracts
- ---------------------------------------------------------------------------------------------------------------------------------
(9) Other
- ---------------------------------------------------------------------------------------------------------------------------------
Total Direct Costs
- ---------------------------------------------------------------------------------------------------------------------------------
(l) Cost of Money
- ---------------------------------------------------------------------------------------------------------------------------------
(m) Overhead
- ---------------------------------------------------------------------------------------------------------------------------------
G&A
- ---------------------------------------------------------------------------------------------------------------------------------
(n) Fixed Fee
- ---------------------------------------------------------------------------------------------------------------------------------
(o) Total Amount Claimed
- ---------------------------------------------------------------------------------------------------------------------------------
(p) Adjustments
- ---------------------------------------------------------------------------------------------------------------------------------
(q) Grand Totals
- ---------------------------------------------------------------------------------------------------------------------------------
I certify that all payments are for appropriate purposes and in accordance with the contract.
______________________________ ________________________________
(Name of Official) (Title)
* Attach details as specified in the contract
=================================================================================================================================
=================================================================================================================================
NIH(RC)-4 ATTACHMENT 2
Rev. 5/97 Page 5
5
PHS 352.223-70 SAFETY AND HEALTH (DEVIATION) (AUGUST 1997)
(a) To help ensure the protection of the life and health of all persons, and to
help prevent damage to property, the Contractor shall comply with all
Federal, State and local laws and regulations applicable to the work being
performed under this contract. These laws are implemented and/or enforced
by the Environmental Protection Agency, Occupational Safety and Health
Administration and other agencies at the Federal, State and local levels
(Federal, State and local regulatory/enforcement agencies).
(b) Further, the Contractor shall take or cause to be taken additional safety
measures as the Contracting Officer in conjunction with the project or other
appropriate officer, determines to be reasonably necessary. If compliance
with these additional safety measures results in an increase or decrease in
the cost or time required for performance of any part of work under this
contract, an equitable adjustment will be made in accordance with the
applicable "Changes" Clause set forth in this contract.
(c) The Contractor shall maintain an accurate record of, and promptly report to
the Contracting Officer, all accidents or incidents resulting in the
exposure of persons to toxic substances, hazardous materials or hazardous
operations; the injury or death of any person; and/or damage to property
incidental to work performed under the contract and all violations for which
the Contractor has been cited by any Federal, State or local
regulatory/enforcement agency. The report shall include a copy of the
notice of violation and the findings of any inquiry or inspection, and an
analysis addressing the impact these violations may have on the work
remaining to be performed. The report shall also state the required
action(s), if any, to be taken to correct any violation(s) noted by the
Federal, State or local regulatory/enforcement agency and the time frame
allowed by the agency to accomplish the necessary corrective action.
(d) If the Contractor fails or refuses to comply promptly with the Federal,
State or local Regulatory/enforcement agency's directive(s) regarding any
violation(s) and prescribed corrective action(s), the Contracting Officer
may issue an order stopping all or part of the work until satisfactory
corrective action (as approved by the Federal, State or local
regulatory/enforcement agencies) has been taken and documented to the
Contracting Officer. No part of the time lost due to any stop work order
shall be subject to a claim for extension of time or costs or damages by the
Contractor.
(e) The Contractor shall insert the substance of this clause in each subcontract
involving toxic substances, hazardous materials, or operations. Compliance
with the provisions of this clause by subcontractors will be the
responsibility of the Contractor.
(End of clause)
Safety and Health Clause (Deviation) ATTACHMENT 3
PHS 352.223-70, (8/97)
27
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. Extensions or renewals of approved existing leases or rentals for
equipment in these Federal Supply Groups are excluded from the provisions of
this article.
NIH(RC)-7 (4/1/84) ATTACHMENT 4
OMB Bulletin 81-16
28
GOVERNMENT PROPERTY
SCHEDULE II-A
N01-AO-02734
NIH Property Number Item Count
- ------------------- ---- -----
00970147 Intensive Care Unit 1
00875006 Nu Aire biological hood 1
00875005 Nu Aire biological hood 1
00970906 Model M-5 Gene Mix-N-Match lift 1
01052235 to 01052280, Stainless steel isolation chambers, 92
01052293 to 01052298, (SMB 6010)
01052305 to 01052344
01052398 to 01052404, Stainless steel 4.3 square foot monkey 74
01052407 to 01052410, cage for isolation chamber. (SMB
01052413 to 01052420, 1025 modified)
01052423 to 01052424,
01052428 to 01052429,
01052431 to 01052434,
01052437, 01052439,
01052443, 01052445,
01052446, 01052448,
01052450, 01052452,
01052455, 01052458,
01052459, 01052461,
01052462, 01052465 to
01052467, 01052469 to
01052477, 01052482 to
01052484, 01052486 to
01052488, 01052491,
01052492, 01052494 to
01052501, 01052404 to
01052510
01041134 Foredom Dental Drill 1
01041137 Surgistal Electrosurgery 1
Serial A4E091A
01041136 Ultra Doppler Flow 1
Detector Model 811
ATTACHMENT 5
29
Cont. GOVERNMENT PROPERTY - SCHEDULE ii-A; N01-AO-02734 Page 2
00970941 Compact 100 Anesthesia Machine with 1
00970942 Anesthesia Ventilator 1
00899786 Pace Tech Pulse Oximeter 1
00970940 K-20 K-Module Localized Heat 1
Therapy Unit
00970939 Chatillon Scale 1
00899102 Scale Stand 1
01205148 Compaq Presario Hard Drive 1
01205149 H-Packard Deskjet Printer, 720c 1
01205151 LACIE Monitor High Resolution 1
-- Power Machine Tosh 9600/200-604e 1
Attachment 5
30