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U.S. SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-QSB
(Mark One)
X QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
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SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended February 29, 2000
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OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
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SECURITIES EXCHANGE ACT
For the transition period from ____________ TO ____________
Commission file number 1-13527
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BIOQUAL, INC.
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(Exact name of small business issuer as specified in its charter)
State of Delaware 13-3078199
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(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification No.)
9600 Medical Center Drive, Rockville, Maryland 20850
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(Address of principal executive office) (Zip Code)
Issuer's telephone number, including area code (301) 251-2801
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(Former name, former address and former fiscal year, if changed since
last report)
Check whether the registrant (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Exchange Act of 1934 during the preceding 12 months
(or for such shorter period that the registrant was required to file such
reports), and (2) has been subject to such filing requirements for the past 90
days. Yes X No
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Check whether the registrant filed all documents and reports required to be
filed by Section 12, 13 or 15(d) of the Exchange Act after the distribution of
securities under a plan confirmed by a court. Yes No X
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Common Stock, $.01 par value per share; authorized 25,000,000 shares; 878,256
shares outstanding as of April 7, 2000.
Transitional Small Business Disclosure Format (Check one): Yes No X
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BIOQUAL, Inc.
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INDEX
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Part I. Financial Information Page
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Item 1. Financial Statements.
Consolidated Balance Sheets, May 31, 1999 and
February 29, 2000 (Unaudited) . . . . . . . . . . . . . . 2
Unaudited Consolidated Statements of Operations for
the Three Months Ended February 29, 2000 and
February 28, 1999 . . . . . . . . . . . . . . . . . . . . 3
Unaudited Consolidated Statements of Operations for
the Nine Months Ended February 29, 2000 and
February 28, 1999 . . . . . . . . . . . . . . . . . . . . 4
Unaudited Consolidated Statements of Cash Flows
for the Nine Months Ended February 29, 2000 and
February 28, 1999 . . . . . . . . . . . . . . . . . . . . 5
Notes to Financial Statements . . . . . . . . . . . . . . . 6
Item 2. Management's Discussion and Analysis . . . . . . . . 6
Part II. Other Information
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Item 6. Exhibits . . . . . . . . . . . . . . . . . . . . . . . 11
1
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BIOQUAL INC. AND SUBSIDIARY
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CONSOLIDATED BALANCE SHEETS, MAY 31, 1999 AND FEBRUARY 29, 2000 (UNAUDITED)
- ---------------------------------------------------------------------------
<TABLE>
<CAPTION>
ASSETS FEBRUARY 29, 2000 MAY 31, 1999
- ------ ----------------- ------------
<S> <C> <C>
CURRENT ASSETS:
Cash and cash equivalents $ 71,185 $ 68,768
Accounts receivable:
Trade 1,284,530 966,354
Unbilled - current 241,353 262,774
Other 19,109 26,867
Prepaid expenses 99,057 91,522
Inventories 256,790 287,596
Loans to officers 32,906
Deferred income taxes - current 68,300 77,300
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Total current assets 2,040,324 1,814,087
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FIXED ASSETS:
Leasehold improvements 939,108 832,264
Furniture, fixtures and equipment 3,550,269 3,289,879
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Total 4,489,377 4,122,143
Less accumulated depreciation and amortization 2,872,215 2,649,058
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Fixed assets, net 1,617,162 1,473,085
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DEFERRED INCOME TAXES - NONCURRENT 600,400 600,400
UNBILLED ACCOUNTS RECEIVABLE - NONCURRENT 393,151 493,512
OTHER NONCURRENT ASSETS 242,650 242,650
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TOTAL $ 4,893,687 $ 4,623,734
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LIABILITIES
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CURRENT LIABILITIES:
Borrowings under line of credit $ 825,129 $ 275,282
Current maturities of long-term debt 66,093 66,093
Accounts payable 193,176 215,956
Accrued compensation and related costs 286,622 474,597
Accrued income taxes 24,281
Other accrued liabilities 8,164 15,178
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Total current liabilities 1,379,184 1,071,387
LONG-TERM DEBT 4,658 56,211
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Total liabilities 1,383,842 1,127,598
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STOCKHOLDERS' EQUITY
- --------------------
Convertible preferred stock - par value of $1.00 per share, 500,000 shares authorized; no
shares issued and outstanding
Common stock - par value of $.01 per share; 25,000,000 shares authorized; 1,600,408 shares 16,004 16,004
issued; February 29, 2000, 877,256 shares, May 31, 1999, 872,672 shares outstanding
Additional paid-in capital 7,475,035 7,475,035
Accumulated deficit (3,281,927) (3,310,022)
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Total 4,209,112 4,181,017
Less - treasury stock February 29, 2000, 723,152 shares, May 31, 1999, 727,736 shares, at cost (699,267) (684,881)
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Total stockholders' equity 3,509,845 3,496,136
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TOTAL $ 4,893,687 $ 4,623,734
=========== ===========
</TABLE>
See notes to financial statements.
2
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BIOQUAL, INC.AND SUBSIDIARY
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UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS FOR THE
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THREE MONTHS ENDED FEBRUARY 29, 2000 AND FEBRUARY 28, 1999
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<TABLE>
<CAPTION>
FEBRUARY 29, FEBRUARY 28,
2000 1999
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<S> <C> <C>
REVENUES AND SALES:
Contract revenues $2,867,429 $2,649,698
Product sales 55,299 35,897
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Total Revenues and Sales 2,922,728 2,685,595
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OPERATING EXPENSES:
Contract 2,272,950 2,102,682
Cost of goods sold 40,892 27,253
Research and development 33,947 54,749
General and administrative 544,550 462,570
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Total 2,892,339 2,647,254
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OPERATING INCOME 30,389 38,341
INTEREST INCOME 1,151 1,147
INTEREST EXPENSE (14,387) (16,067)
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INCOME BEFORE INCOME TAX 17,153 23,421
PROVISION FOR INCOME TAX 7,000 9,400
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NET INCOME $ 10,153 $ 14,021
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BASIC EARNINGS PER SHARE $ 0.01 $ 0.02
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DILUTED EARNINGS PER SHARE $ 0.01 $ 0.02
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WEIGHTED AVERAGE NUMBER OF SHARES
OUTSTANDING FOR BASIC EARNINGS PER SHARE 872,083 887,739
EFFECT OF DILUTIVE SECURITIES - OPTIONS 9,381 16,225
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WEIGHTED AVERAGE NUMBER OF SHARES
OUTSTANDING PLUS DILUTIVE OPTIONS FOR
DILUTIVE EARNINGS PER SHARE 881,464 903,964
========== ==========
</TABLE>
See notes to financial statements.
3
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BIOQUAL, INC.AND SUBSIDIARY
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UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS FOR THE
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NINE MONTHS ENDED FEBRUARY 29, 2000 AND FEBRUARY 28, 1999
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<TABLE>
<CAPTION>
FEBRUARY 29, FEBRUARY 28,
2000 1999
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<S> <C> <C>
REVENUES AND SALES:
Contract revenues $8,564,407 $8,027,867
Product sales 94,809 42,975
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Total Revenues and Sales 8,659,216 8,070,842
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OPERATING EXPENSES:
Contract 6,814,748 6,167,582
Cost of goods sold 76,932 36,643
Research and development 134,818 140,956
General and administrative 1,517,040 1,397,013
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Total 8,543,538 7,742,194
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OPERATING INCOME 115,678 328,648
INTEREST INCOME 2,771 2,788
INTEREST EXPENSE (41,994) (41,471)
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INCOME BEFORE INCOME TAX 76,455 289,965
PROVISION FOR INCOME TAX 31,000 116,000
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NET INCOME $ 45,455 $ 173,965
========== ==========
BASIC EARNINGS PER SHARE $0.05 $0.19
========== ==========
DILUTED EARNINGS PER SHARE $0.05 $0.19
========== ==========
WEIGHTED AVERAGE NUMBER OF SHARES
OUTSTANDING FOR BASIC EARNINGS PER SHARE 870,624 894,714
EFFECT OF DILUTIVE SECURITIES - OPTIONS 9,381 16,225
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WEIGHTED AVERAGE NUMBER OF SHARES
OUTSTANDING PLUS DILUTIVE OPTIONS FOR
DILUTIVE EARNINGS PER SHARE 880,005 910,939
========== ==========
</TABLE>
See notes to financial statements.
4
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BIOQUAL, INC. AND SUBSIDIARY
- ----------------------------
UNAUDITED CONSOLIDATED STATEMENTS OF CASH FLOWS FOR THE
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NINE MONTHS ENDED FEBRUARY 29, 2000 AND FEBRUARY 28, 1999
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<TABLE>
<CAPTION>
February 29, February 28,
2000 1999
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<S> <C> <C>
CASH FLOWS FROM OPERATING ACTIVITIES:
Net Income $ 45,455 $ 173,965
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Adjustments to reconcile net income to net cash
used for operating activities:
Depreciation and amortization 223,157 235,877
Deferred income taxes 9,000 82,400
Increase in accounts receivable (188,636) (791,217)
Increase in prepaid expenses (7,535) (37,779)
Decrease (increase) in inventories 30,806 (219,765)
Decrease in other assets 38,148
Decrease in accounts payable and accrued expenses (217,769) (85,891)
Common stock gifted to employees 9,392
Decrease in income taxes payable (24,281) (6,376)
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Total Adjustments (165,866) (784,603)
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NET CASH USED FOR OPERATING ACTIVITIES (120,411) (610,638)
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CASH FLOWS USED FOR INVESTING ACTIVITIES:
Capital expenditures (367,234) (183,031)
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NET CASH USED FOR INVESTING ACTIVITIES (367,234) (183,031)
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CASH FLOWS FROM FINANCING ACTIVITIES:
Net proceeds under line-of-credit agreement 549,847 909,914
Net proceeds from exercise of stock options 9,131 81
Dividends paid (17,363)
Principal payments under capital lease obligations (51,553) (113,990)
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NET CASH PROVIDED BY FINANCING ACTIVITIES 490,062 796,005
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NET INCREASE IN CASH AND CASH EQUIVALENTS 2,417 2,336
CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD 68,768 65,730
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CASH AND CASH EQUIVALENTS AT END OF PERIOD $ 71,185 $ 68,066
========= =========
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION
Cash paid during the period for:
Interest $ 40,857 $ 39,543
========= =========
Income taxes $ 58,725 $ 39,976
========= =========
SUPPLEMENTAL SCHEDULE OF NONCASH INVESTING ACTIVITIES:
Treasury stock received for payment of loans to officer $ 32,906 $ 35,719
========= =========
</TABLE>
See notes to financial statements.
5
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NOTES TO FINANCIAL STATEMENTS
Interim Financial Statements
- ----------------------------
In the opinion of management, all adjustments consisting only of normal
recurring accruals necessary for a fair presentation of such amounts have been
included. The results of operations for the quarter and the nine month period
are not necessarily indicative of results for the year.
Inventories
- -----------
Inventories are stated at the lower of cost or market using the average cost
method.
Item 2. MANAGEMENT'S DISCUSSION AND ANALYSIS
Summary Analysis
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In this third quarter of fiscal year 2000, BIOQUAL (hereinafter, "the Company"
or "BIOQUAL") realized net income of $10,153. Net income for the first nine
months of fiscal year 2000 totaled $45,455.
On December 31, 1999, Diagnon Corporation ("Diagnon") changed its name to
BIOQUAL, Inc. The name change was effected as a result of the merger of Diagnon
and its wholly owned subsidiary, BIOQUAL, Inc., with Diagnon being the surviving
corporation. In the merger Diagnon adopted the name BIOQUAL, Inc. as the name
of the surviving entity. The business and operations of BIOQUAL, Inc. will be
the same as the consolidated business and operations of Diagnon together with
its wholly owned subsidiaries prior to the merger.
During the third quarter the following developments occurred:
. On December 28, 1999, BIOQUAL renewed its contract to support hepatitis
researchers at the National Institute of Allergy and Infectious Diseases
(NIAID). The contract entitled "Care and Housing of Hepatitis Research
Animals" totals $13,634,742 and extends for seven years to December 2006.
. On January 28, 2000, BIOQUAL renewed its contract to support AIDS
researchers at the NIAID. The contract entitled "Care and Housing of AIDS
Research Animals" totals $10,798,411 and extends for seven years to
January 2007.
. On February 29, 2000, the Company renewed its contract to support
infectious disease researchers at the NIAID. The contract entitled
"Facility for Animals Used in Infectious Disease Research" totals
$6,298,647 and extends for seven years to February 2007.
Subsequent to the end of the quarter the following developments occurred:
. On March 2, 2000, the Company was awarded a $99,153 Phase I grant from the
National Institutes of Health as part of its Small Business Innovation
Research (SBIR) program. The six month grant
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is to identify and characterize DNA sequence variation in chimpanzees at
four genes that contain mutations implicated in the pathogenesis of
Alzheimer's Disease.
. The NIAID contract, "MAO/Evaluation of AIDS Vaccines in Non-Human
Primates" expired on March 31, 2000. This contract accounts for
approximately 1% of the Company's projected revenues for fiscal year 2000.
The expiration of this contract will have minimal effect on the Company's
revenues and operating capital.
Year 2000
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The Company performed an internal assessment of the scope of the Year 2000
computer systems and software problems and its potential effect on the operation
of the Company. The Company continues to monitor its information and non-
information systems for signs of malfunction due to the Year 2000 computer
problem. The Company has not encountered any delays of service or non-service
from its major suppliers of products and services, however there can be no
assurance that the Company will not be affected by another company's Year 2000
non-compliance. The Company spent approximately $20,000 in fiscal year 1999 and
approximately $23,000 to date in fiscal year 2000 to replace non-compliant
computers and software. Any costs incurred in connection with Year 2000
compliance were expensed as incurred. It is the opinion of management that the
Year 2000 computer problem will not have a material effect on the Company's
operation. However, the Company continues to monitor the status of its largest
customer, the National Institutes of Health (NIH), regarding Year 2000
compliance. The NIH states that all of its mission critical systems and 98% of
its non-mission critical systems are currently compliant. However, if the NIH
does experience Year 2000 related problems, the Company's financial condition
may be adversely affected until such time that the NIH's non-compliant
contingency plan is initiated.
Not all instances of date failure can be anticipated or controlled. In planning
for the most reasonably likely worst-case scenario, (e.g. NIH systems being non-
compliant after January 1, 2000), or in cases which, despite our efforts,
failures occur, we have developed a contingency plan. The contingency plan
includes the stockpiling of critical materials necessary to maintain operations.
Results of Operations
- ---------------------
Three Months Comparison
- -----------------------
For the three months of operations ended February 29, 2000 (the Company's third
quarter in fiscal year 2000), contract revenues increased by 8.2% or $217,731 to
$2,867,429 compared to $2,649,698 in the third quarter of fiscal year 1999.
This increase was due to increased government contract activity including
approximately $69,000 in costs incurred related to a toxicity study which began
this quarter. However, the increase is not as large as anticipated due to a
decrease in the number of commercial contracts compared to the third quarter of
fiscal year 1999 and the expiration of a major contract on November 8, 1998.
Product sales increased to $55,299 for the quarter ended February 29, 2000
compared to $35,897 for the same quarter in fiscal year 1999.
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Contract operating expenses increased 8.1% or $170,268 compared to the third
quarter of fiscal year 1999 primarily due to increased government contract
activity (including the $69,000 in costs incurred related to a toxicity study as
mentioned above), an increase in overhead expenses supporting the equine
production facility of approximately $35,000 compared to the third quarter in
fiscal year 1999, offset by the decrease in commercial contracts. Cost of goods
sold increased to $40,892 from $27,253 in the third quarter of fiscal year 1999.
This increase was primarily due to the increase in units sold during this fiscal
year. Research and development (R&D) expenses decreased to $33,947 compared to
$54,749 in the third quarter of fiscal year 1999. This decrease is primarily due
to the temporary reassignment of R&D staff to prepare Small Business Innovative
Research (SBIR) grant proposals to possibly provide additional funding for the
research associated with the high throughput assay system currently being
developed by the Company's Department of Discovery Research. General and
administrative expenses increased 17.7% compared to the third quarter of fiscal
year 1999 primarily due to inflationary increases in several items of expense
plus the increased costs associated with the preparation of the SBIR grant
proposals this quarter compared to fiscal year 1999. Total operating expenses
increased 9.3% due to the above.
Operating income decreased to $30,389 for the third quarter of fiscal year 2000
compared to $38,341 in the same quarter in the prior year. The decrease is
primarily due to the following factors: 1) the increase in contract expenses
without a comparative increase in related contract revenues resulting in a
decrease in the gross margin percentage on contracts this fiscal year, 2) the
increase in overhead expenses supporting the equine production facility of
approximately $35,000, offset by 3) the increase in government contract
activity.
For this quarter, the Company had interest expense of $14,387 compared to
interest expense of $16,067 in the prior year.
In accordance with SFAS No. 109, "Accounting for Income Taxes", the Company
reported a deferred federal income tax expense of $4,000 for the three months
ended February 29, 2000. The Company made a provision for state income tax
which is estimated at $3,000. State income tax expense is reimbursable under
government contracting regulations.
Earnings Per Share (EPS) - For the three month comparison, options to purchase
29,502 shares of common stock at prices ranging from $2.8875 per share to $3.375
per share were outstanding on February 29, 2000 but were not included in the
computation of diluted EPS because the option exercise prices were greater than
the market price of the common shares. Options to purchase 59,345 shares of
common stock at prices ranging from $1.80 per share to $3.375 per share were
outstanding on February 28, 1999 but were not included in the computation of
diluted EPS because the option exercise prices were greater than the market
price of the common shares.
Nine Month Comparison
- ---------------------
For the nine months of operations ended February 29, 2000, contract revenues
increased by 6.7% or $536,540 to $8,564,407 compared to $8,027,867 for the first
nine months of fiscal year 1999. This increase was due to increased government
contract activity including two one-time
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purchases totaling approximately $210,000 during the second quarter of this
fiscal year and $69,000 in costs incurred related to a toxicity study which
began during the third quarter of this fiscal year. However, the increase is not
as large as anticipated due to a decrease in the number of commercial contracts
compared to the first nine months of fiscal year 1999, the end of a major
contract on November 8, 1998, the fiscal year 1999 funding of a $34,976 indirect
rate variance cost overrun of a contract that expired in fiscal year 1995 (the
contract was administratively closed out on September 30, 1998), and a fiscal
year 2000 reserve for a $50,000 cost overrun, due to indirect cost variances, on
a contract that expired on December 27, 1999. Product sales increased to $94,809
for the nine month period ending February 29, 2000 compared to $42,975 for the
same period in fiscal year 1999. Contract operating expenses increased 10.5% or
$647,166 compared to the first nine months of fiscal year 1999 primarily due to
increased government contract activity (including the two one-time purchases
totaling approximately $210,000 and the $69,000 toxicity study mentioned above),
an increase in overhead expenses supporting the equine production facility of
approximately $95,000 compared to the first nine months in fiscal year 1999,
offset by the decrease in commercial contracts. Cost of goods sold increased to
$76,932 from $36,643 in the first nine months of fiscal year 1999. This increase
was primarily due to the increase in units sold during this fiscal year and the
expensing of 22 free doses of Eqstend. Research and development (R&D) expenses
decreased to $134,818 compared to $140,956 in the first nine months of fiscal
year 1999. This decrease is primarily due to the temporary reassignment of R&D
staff (during the third quarter of fiscal year 2000) to prepare Small Business
Innovative Research (SBIR) grant proposals to possibly provide additional
funding for the research associated with the high throughput assay system
currently being developed by the Company's Department of Discovery Research as
previously mentioned. General and administrative expenses increased 8.6%
compared to the first nine months of fiscal year 1999 primarily due to
inflationary increases in several items of expense plus the increased costs
associated with the preparation of the SBIR grant proposals during the third
quarter of fiscal year 2000 compared to fiscal year 1999, offset by a decrease
in legal expenses during this year compared to fiscal year 1999. Total operating
expenses increased 10.4% due to the above.
Operating income decreased to $115,678 for the nine month period ending February
29, 2000 compared to $328,648 for the same period in the prior year. The
decrease is primarily due to several factors: 1) the increase in contract
expenses without a comparative increase in related contract revenues resulting
in a decrease in the gross margin percentage on contracts this fiscal year, 2)
the increase in overhead expenses supporting the equine production facility of
approximately $95,000, 3) the reserve for a $50,000 cost overrun, due to
indirect cost variances, on a contract that ended on December 27, 1999 and 4)
$34,976 increased funding to cover an indirect cost overrun for an expired
contract during the previous fiscal year as mentioned above.
For the nine months of this fiscal year, the Company had interest expense of
$41,994 compared to interest expense of $41,471 in the prior year.
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In accordance with SFAS No. 109, "Accounting for Income Taxes", the Company
reported a deferred federal income tax expense of $9,000 for the nine months
ended February 29, 2000. The Company made a provision for state income tax
which is estimated at $22,000. State income tax expense is reimbursable under
government contracting regulations.
Earnings Per Share (EPS) - For the nine month comparison, options to purchase
29,502 shares of common stock at prices ranging from $2.8875 per share to $3.375
per share were outstanding on February 29, 2000 but were not included in the
computation of diluted EPS because the option exercise prices were greater than
the market price of the common shares. Options to purchase 59,345 shares of
common stock at prices ranging from $1.80 per share to $3.375 per share were
outstanding on February 28, 1999 but were not included in the computation of
diluted EPS because the option exercise prices were greater than the market
price of the common shares.
Liquidity and Capital Resources
- -------------------------------
Assets
The changes in cash and cash equivalents are detailed in the Statements of
Consolidated Cash Flows on page 5. Total assets increased $269,953 from
$4,623,734 at May 31, 1999 to $4,893,687 at February 29, 2000. This amount was
primarily attributable to an increase in accounts receivable of $188,636
consisting mainly of 1) an increase of $318,176 in trade accounts receivable
reflecting a slower collection rate compared to the previous fiscal year end, 2)
a $121,782 net decrease in unbilled accounts receivable (current plus
noncurrent) primarily resulting from a $1,427 increase in reimbursable indirect
rate variances for the current fiscal year, a net $92,976 decrease in month end
accrued sales on accrued direct labor comparing the current period and the
accrual at the end of fiscal year 1999, the recording of $19,767 unbilled
contract fee retention to be billed at the completion of the respective
contracts, and a $50,000 reserve for a cost overrun, due to indirect rate
variances from prior years, on a contract that expired on December 27, 1999, and
3) a $7,758 decrease in other accounts receivable. Prepaid expenses increased
$7,535 primarily due to the prepayment of life insurance premiums. Fixed
assets, net of accumulated depreciation and amortization increased $144,077
reflecting fixed asset purchases of $367,234 (mainly nonhuman primate
enclosures, lab equipment, and facility improvements) offset by depreciation and
amortization of $223,157.
The above increase is partially offset by 1) a decrease in loans to officers of
$32,906 due to payments made during the this fiscal year, 2) a deferred income
tax decrease of $9,000 primarily as a result of utilizing a portion of the
federal income tax loss carryforward, and 3) a $30,806 decrease to inventories.
The balance of the increase was due to other miscellaneous factors.
Liabilities
In the first nine months of operations, total liabilities increased $256,244
from $1,127,598 at May 31, 1999 to $1,383,842 at February 29, 2000. This
increase is primarily attributable to an increase to borrowings under line-of-
credit of $549,847 reflecting the slow
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collection of trade accounts receivable and the payment of accrued bonuses from
the previous fiscal year.
The above increase is partially offset by 1) a decrease in accrued compensation
and related costs of $187,975 reflecting the payment of accrued bonuses from
fiscal year 1999 during the first quarter of this fiscal year and a shorter
accrual period at the end of the quarter compared to the prior fiscal year end.
2) payments totaling $51,553 on capital leases reducing long-term debt, 3) a
decrease in accrued income taxes of $24,281, 4) a decrease in accounts payable
of $22,780, and 5) a decrease in other accrued liabilities of $7,014. The
balance of the increase was due to other miscellaneous factors.
Stockholders' Equity
During the second quarter the company paid a cash dividend totaling $17,363 to
shareholders of record as of September 7, 1999.
Capital Resources
The Company believes it has sufficient cash and financing sources to provide for
its ongoing operations and the Company continues to believe that the impact of
inflation, or the absence of it, will have no significant effect on its
operations.
Forward Looking Information
Statements herein that are not descriptions of historical facts are forward
looking and subject to risk and uncertainties. Actual results could differ
materially from those currently anticipated due to a number of factors including
those set forth in BIOQUAL's Securities and Exchange Commission filings under
"Risk Factors", including risks relating to the early stage of products under
development; uncertainties relating to clinical trials; dependence on third
parties' future capital needs; and risks relating to the commercialization, if
any, of BIOQUAL's proposed products (such as marketing, safety, regulatory,
patent, product liability, supply, competition and other risks).
Item 4. EXHIBITS
Exhibits filed
--------------
(10) Government Contracts.
--------------------
1. Title: Care and Housing of Hepatitis Research Animals.
Institute: National Institute of Allergy and Infectious Diseases
Dates Funded: 12/28/99 - 12/27/06
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
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3. Title: Facility for Animals Used in Infectious Disease
Research.
Institute: National Institute of Allergy and Infectious Diseases
Dates Funded: 3/1/00 - 2/28/07
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SIGNATURES
----------
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused the report to be signed on its behalf by the
undersigned thereunto duly authorized.
BIOQUAL, Inc.
DATE April 13, 2000 /s/ John C. Landon
-------------------- --------------------------------
Chairman of the Board,
President and Chief Executive
Officer
DATE April 13, 2000 /s/ Michael P. O'Flaherty
-------------------- --------------------------------
Chief Operating Officer and
Secretary
DATE April 13, 2000 /s/ David A. Newcomer
-------------------- --------------------------------
Chief Financial Officer
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Exhibit 10.1
EXHIBITS
- --------
(10) Government Contracts.
--------------------
1. Title: Care and Housing of Hepatitis Research Animals.
Institute: National Institute of Allergy and Infectious Diseases
Dates Funded: 12/28/99 - 12/27/06
<PAGE>
<TABLE>
<CAPTION>
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-02733 See Item 20.C 001970
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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 G.3.
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CODE FACILITY CODE
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11. SHIP TO/MARK FOR 12. PAYMENT WILL BE MADE BY CODE
OFM/NIH 301-496-6452
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13. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION 14. ACCOUNTING AND APPROPRIATION DATA
N/A DOC# N1AO02733; EIN#1521244771A1; OC 25.2E
CAN# 08325797, Amount Allotted $1,737,039
[ ] 10 U.S.C. 2304 (c)( ) [ ] 41 U.S.C. 253(c)( )
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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 Hepatitis Research Animals
Period: December 28, 1999 through December 27, 2006
Amount allotted: $1,737,039
Contract Type: CPFF - Completion
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15G. TOTAL AMOUNT OF CONTRACT $13,634,742
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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
--- RFP 99-56 including the full additions or changes made by
to issuing office.) Contractor agrees to furnish and deliver -------------- you which additions or changes are set forth in
all items or perform all the services set forth or otherwise full above, is hereby accepted as to the items listed above and
identified above and on any continuation sheets for the on 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
--------------------------------------- 12/27/99 --------------------------------------- 12/27/99
(Signature of person authorized to sign) (Signature of Contracting Officer)
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DETAILED TABLE OF CONTRACT CONTENTS
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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........................................................ 8
Article G.3. Invoice Submission/Contract Financing Request and Financial Report... 8
Article G.4. Indirect Costs Rates................................................. 8
Article G.5. Government Property.................................................. 9
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...................................................... 10
Article H.3. Animal Welfare Assurance............................................. 10
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
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PART I - THE SCHEDULE
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 110 non-human
primates, consisting of approximately 25 infant and juvenile chimpanzees, 80 Old
World and New World non-human primates, and a small amount of species other than
non-human primates (consisting primarily of woodchucks, but on occasion rats,
mice, rabbits, or Guinea pigs). In addition, the contractor shall conduct
routine procedures on these animals, which shall include, but are not be limited
to inoculation of the animals with various hepatitis agents, monitoring animals
for signs of disease, treatment with therapeutic regimens, and collection of
specimens as described by NIAID protocols furnished by the NIAID Project
Officer. The contractor will ship collected specimens to NIAID scientists for
the conduct of experiments and specialized tests. The nature of investigations
being conducted by NIAID scientists are long-term, overlapping, labor intensive
studies which will necessitate that the contractor maintain individual animals
for periods longer than 12 months (see STATEMENT OF WORK, ATTACHMENT 1).
ARTICLE B.2. ESTIMATED COST AND FIXED FEE
a. The estimated cost of this contract is $12,694,007.
b. The fixed fee for this contract is $940,735. 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 $13,634,742.
d. Total funds currently available for payment and allotted to this contract
are $1,737,039 of which $1,619,189 represents the estimated costs, and of
which $117,850 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 December 27, 2000.
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) Foreign travel;
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(6) Consultant Costs
(7) Subcontracts
(8) Patient care costs;
(9) 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.
(10) Printing Costs (as defined in the Government Printing and Binding
Regulations).
(11) Research Funding
ARTICLE B.4. ADVANCE UNDERSTANDINGS
(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) Overtime (premium) pay costs shall not exceed a total of $76,180 unless
prior approval is granted by the Contracting Officer via a Contract
modification.
(4) 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.
(5) 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 below (see SECTION J,
ATTACHMENT 1, dated 4/5/99), attached hereto and made a part if this
Solicitation:
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ARTICLE C.2. REPORTING REQUIREMENTS
a. Technical Progress Reports
In addition to the required reports set forth elsewhere in this Schedule, the
contractor shall submit monthly Technical Progress Reports. These reports
will include descriptive information about the activities and associated
costs undertaken during the reporting period, and information about planned
activities for future reporting periods. The technical progress reports
shall also include a description of the work performed on active NIAID
protocols, the number and outcome of procedures conducted on animals,
problems encountered, their resolutions, and any recommendations to avoid
similar problems in the future. In addition, provide the census of animals
by specie for the reporting period, and the animals' health status before,
during and after the procedures were completed.
The following reports shall be required as follows:
(X) Monthly - 4 copies
(X) Final - 4 copies
b. Summary of Salient Results
The Contractor will be required to prepare and 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. 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 Infectious Diseases, NIAID
Building 7, Room 202
9000 Rockville Pike
Bethesda, MD 20892
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:
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Laboratory of Infectious Diseases, NIAID
Building 7, Room 202
9000 Rockville Pike
Bethesda, Maryland 20892.
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 December 28, 1999
through December 27, 2006.
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 Section J. Attachment 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
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a) Monthly Reports 4 10 Days after end of Month
b) Final Report 4 15 Days after end of Contract
c. The above items shall be addressed and delivered to:
Addressee Deliverable Item No. Quantity
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Project Officer, LID,NIAID (a) 2
Bldg. 7, Rm. 202 (b) 2
9000 Rockville Pike
Bethesda, MD 20892
Ivan Hernandez, Contracts (a) 2
Specialist, NIAID, NIH (b) 2
6700-B Rockledge Dr., Rm. 1127
Bethesda, MD 20892-7605
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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 Infectious Diseases, NIAID
Building 7, Room 202
9000 Rockville Pike
Bethesda, MD 20892
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. Robert Purcell
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.
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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
---- -----
R. Bradbury, D.V.M. Principal Investigator
Mr. Max Shapiro Research Associate
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:
Contract Specialist
Acquisitions Management and Operations Branch
National Institute of Allergy and Infectious Diseases
National Institutes of Health, MSC 7605
Rockledge Building, 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.
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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
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-52705, 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.
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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 106-113 Section 505 Federal Fiscal Year 2000
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.
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. P.L. 106-113 Section 507 Federal Fiscal Year 1999
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
[email protected] 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)
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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:
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FAR
CLAUSE
NO. DATE TITLE
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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
</TABLE>
11
<PAGE>
<TABLE>
<S> <C> <C>
52.216-7 Apr 1998 Allowable Cost and Payment
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)
</TABLE>
12
<PAGE>
<TABLE>
<S> <C> <C>
52.243-2 Aug 1987 Changes - Cost Reimbursement, Alternate I (Apr 1984)
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
</TABLE>
b. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48
CFR CHAPTER 3) CLAUSES.
<TABLE>
<CAPTION>
HSAR
CLAUSE
NO. DATE TITLE
------ ---- -----
<S> <C> <C>
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
</TABLE>
[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.
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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
<PAGE>
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
<PAGE>
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, (5/97), 5 pages.
3. Safety and Health (Deviation), PHSAR Clause 352.223-70, August 1997, 1 pages.
4. Procurement of Certain Equipment, NIH(RC)-7, (OMB Bulletin 81-16), April
1984, 1 page.
5. Government Property - Schedule II-A
16
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PART IV
SECTION K - REPRESENTATIONS AND CERTIFICATIONS (Negotiated).
The following documents are incorporated by reference in this contract:
1. Representations and Certifications, dated October 18, 1999.
2. Certificate of Current Costs or Pricing Data (FAR 15.406-2), dated
12/20/1999.
3. Animal Welfare Assurance Number A3086-01.
17
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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.
A. Specifically, the Contractor shall:
1. Provide continued housing, feed and care for an estimated 110 non-human
primates, consisting of approximately 25 infant and juvenile chimpanzees, 80
Old World and New World non-human primates and a small amount of species
other than non-human primates (consisting primarily of woodchucks, but on
occasion rats, mice, rabbits or Guinea pigs). The use of species other than
non-human primates will represent a small part (less than 1%) of the level of
effort for the Statement of Work. The Contractor must only state their
capability and willingness to accommodate species other than non-human
primates. No cost information for species other than non-human primates is
required. However, if the costs associated with work using species other than
non-human primates appear that they will exceed 1%, fiscal accounting will be
required.
2. Perform routine procedures on these animals which shall include, but not
be limited to: inoculation of the animals with various hepatitis agents,
monitoring animals for signs of disease, treatment with therapeutic regimens,
and collection of specimens as descried by protocols furnished by the Project
Officer. The performance of specialized tests on specimens collected by the
Contractor shall be the responsibility of Government scientists. However the
costs associated with collection of specimens such as blood, samples for
virus isolation, and specimens for pathologic observations shall be the
responsibility of the Contractor. It is estimated that the following shall be
required:
a. Procedures: (1) Inoculations: Intravenous, intraperitoneal, subcutaneous,
and intra muscular (2) Ultrasound-guided transfection of the liver and liver
biopsy and bile aspiration (3) Plasmapheresis (4) Leukopheresis (5) Lavages
(6) Gavages (7) Biopsies: Liver, lymph node, intestine, bone marrow, CSF,
skin, bile. (8) Dynamic color flow abdominal imaging and echocardiography.
b. Specimens: Liver, CSF, sera, plasma, PBMC, lymph node, intestine, bone
marrow, lavage/gavage samples, bile, feces, skin.
c. Survival Surgery: Laparotomy to collect up to 10% of the liver by open
biopsy; laparotomy-guided transfection of the liver or liver biopsy.
d. Necropsy: Comprehensive necropsy at completion of terminal studies.
Deliver upon request, clinical specimens, drawn freshly from the animal, to
NIAID within 2 hours after being drawn; preferably by 11:00 A.M. on the day
obtained in order to achieve optimal virus viability.
The Contractor's professional and technical personnel assigned to the
contract shall meet with scientists in the Hepatitis Viruses Section and
Molecular Hepatitis Section, Laboratory of Infectious Diseases, NIAID,
Building 7, Room 202, Bethesda, Maryland biweekly to monthly as needed for 2
hours, commencing at 1400-1500 hours.
The Contractor shall function as a central receiving and shipping point and
repository for samples exchanged between USA and international collaborators
with NIAID scientists.
Conduct some protocols in accordance with 21 CFR, Chapter 1, Food and Drug
Administration, Part 58-Good Laboratory Practices For Nonclinical Laboratyory
Studies.
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
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<PAGE>
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.
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:
1. Non-human Primate Caging Specifications:
(1) 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 are essential for hepatitis virus
research.
(2) Chimpanzee housing shall be of a design that provides biocontainment
as well as an enriched environment including an adjacent exercise area.
Specifically, the air handling shall prevent the acquisition of viruses,
especially respiratory viruses, by the chimpanzees from their animal
handlers and vice versa. The primary enclosure shall be at least 25 sq.
ft. of floor space with an internal height of 84 inches. An adjacent
exercise area shall be at least 35 sq. ft. of floor space with an interior
height of 84 inches. The primary enclosure shall be equipped with a
squeeze mechanism to gain control of the chimpanzee for injections or to
persuade the chimpanzee to enter a transfer cage. The primary enclosure
shall have an adjacent service area door that can be closed when the
chimpanzee is being manipulated. When required, chimpanzees shall be
individually housed with exclusive access to both a primary enclosure area
and an exercise area. Individually housed chimpanzees shall have visual
contact with conspecifics. These enclosures shall be designed to be washed
and disinfected in place.
2. HVAC: The Contractor shall use its best efforts to maintain 74-76 degrees
F. and 15 air changes/hour.
3. 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.
4. Medical Pathological Waste (MPW): The disposition of potentially infected
materials shall be accomplished, sequentially, in the following manner:
(1) Animal Room Waste: a. Liquids: sewage pipes, decontamination tanks at
210F. for 2 hours, public sewage system. B. Solids: double sealed bag,
sterilized, dumpster.
19
<PAGE>
(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.
(5) Gowns: sealed bag, commercial laundry service.
e. Environmental Enrichment: The Contractor shall provide plans for enriching
the environment of non-human primates.
f. 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. Chimpanzees shall be
fed four times daily consisting of standard biscuit ration plus three
rations of a variety of fruit and vegetables, distributed throughout the
day.
g. 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.
(9) Treatment Instructions.
The Contractor shall 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.
5. 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
20
<PAGE>
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). All Personnel shall be immunized against hepatitis A
and B and other relevant diseases as vaccines become available. Persons
positive for hepatitis B surface antigen or antibody to hepatitis C virus
shall not work with animals on this contract.
6. Veterinary Medical Care:
a. 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. Necropsies will be
performed as needed.
B. The Contractor shall adhere to the following:
1. The organization must have, or be able to obtain before the submission of
a Final Proposal, 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 the following legal requirements:
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
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. Biosafety in Microbiological and Biomedical Laboratories (CDC-NIH 1993).
e. 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).
3. All non-human primates housed under this contract will be provided by the
Government.
21
<PAGE>
4. All Proposals for animal 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.
22
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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
<PAGE>
(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
<PAGE>
(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
<PAGE>
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
<PAGE>
SAMPLE INVOICE/FINANCING REQUEST AND CONTRACT FINANCIAL REPORT
<TABLE>
=================================================================================================================================
<S> <C>
(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 ___________
=================================================================================================================================
</TABLE>
<TABLE>
<CAPTION>
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
- ---------------------------------------------------------------------------------------------------------------------------------
<S> <C> <C> <C> <C> <C> <C> <C>
(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
=================================================================================================================================
=================================================================================================================================
</TABLE>
NIH(RC)-4 ATTACHMENT 2
Rev. 5/97 Page 5
27
<PAGE>
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)
28
<PAGE>
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
29
<PAGE>
GOVERNMENT PROPERTY - SCHEDULE II-A
<TABLE>
<CAPTION>
Item Quantity
---- --------
<S> <C>
Damon Centrifuge 2
Monitor 1
CPU, AST 1
Mouse 1
Keyboard 1
Biological safety cabinet 1
Sero-Fug-2 tabletop centrifuge 1
Hematocrit centrifuge 1
X-ray reader 1
Suction pump 1
Ultra lo chest freezer 1
Crystal tips ice machine 1
Genie Mix-n-match lift 1
Liquid nitrogen freezer, portable 1
Refrigerator, 24 feet coldspot 1
Undercounter incubator 1
Refrigerator, 3 door 1
Monitor, RGB As 1
Disk Drive 5.25 1
Modem 1
Mouse, Apple 1
Keyboard, expanded 1
Printer, laser writer plus 1
Monitor, RGB 13" 1
Monitor, NEC multisync As 1
CPU, MacII fx 1
Printer, image writer II 1
Aluminum hand trucks, 2 wheel 5
Stnl stl gen purpose cage (for rabbits or guinea pigs) 6
Stainless steel dip tank 2
Stainless steel feed carts 6
Alminum 4 wheel truck, 5' long 1
Scale 1
Refrigerator, 16 feet coldspot 1
Stainless steel surgery table 1
P-2000 Mattler scale 1
Exact weight scale 1
Sprint 125 X-ray machine 1
X-ray film cabinet 1
</TABLE>
Government Property - Schedule II-A ATTACHMENT 5
(12/27/99)
30
<PAGE>
<TABLE>
<CAPTION>
Item Quantity
---- --------
<S> <C>
Fire proof safety cabinet 46"x43" 1
Refrigerator, Walk-in 1
Scale 1
Necropsy table 1
A.O. microscope 1
Ultra sonic cleaning machine 1
IEC-600 centrifuge 1
Micro-hematrocrit centrifuge 1
Stainless steel surgery cabinet 1
Stainless steel surgery table 1
Veterinary anesthesia machine, Heidbrink 1
Wall mount surgery light 3
Freezer, upright 1
Ultralo chest freezer w/graphic recorder 1
Freezer, 17 feet upright 1
Freezer, -20C, 2-door w/ graphic recorder 1
Teeth cleaning machine 1
Refrigerator, 18 ft. Coldspot 1
Stainless steel surgery cabinet 1
Stainless steel isol. Chamber 35
Aluminum chambers, lrg., for chimps 1
Aluminum chambers, med. for chimps 2
Stainless steel hanging metabolism cage 4
Aluminum chimpanzee transport cage 4
Stainless steel 4.3 sq. ft. cage 33
Stainless steel 4.0 sq. ft. cage 30
Aluminum cage dolly, 4 wheel 2
Stainless steel meshed-wire dbl tiered cage 34
Aluminum cage, med, for use in med alum chamber 10
Stainless steel meshed-wire dbl tiered cage 3
Aluminum transport cage 39
Large cages 28
Stainless steel cart, lrg to store plastic bags 1
Drying oven 1
Bnch cbnt w/ 4 drawers 1
Bnch cbnt w/ 4 drawers 1
Bnch w/sink & 2 drawers 1
Bnch cbnt w/ 4 drawers 1
Wallcase w/sliding doors 1
Facsimile (FAX) machine 1
Dynaview Ultrasound Console, SSD-1700 Dynaview 1
7.5 MHZ 40R/60 DEG Convex Probe, UST-9191-7.5 1
5 MHZ 14R/90 DEG untercoastal convex, UST-9103-5 1
Sony Color Printer UP-1800MD 1
</TABLE>
Government Property - Schedule II-A ATTACHMENT 5
(12/27/99)
31
<PAGE>
<TABLE>
<CAPTION>
Item Quantity
---- --------
<S> <C>
Physiological Signal Display Unit, PEU-1700 1
Video Cassette Recorder (VCR) 1
DAS-5007 Pocket Scanner System, P200 4GB 32 2
IPTT-Implantable Programmable Temp. Transponders 1
DASLINK DOS Communication Software 1
DIN8/FDB9 ST DAS-5000 Series Straightline Cable 1
</TABLE>
Government Property - Schedule II-A ATTACHMENT 5
(12/27/99)
32
<PAGE>
EXHIBITS
--------
(10) Government Contracts.
---------------------
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
<PAGE>
<TABLE>
<CAPTION>
STANDARD FORM 26 (REV. 4-85) NSN 7540-01-152-8069 OMB No. 0990-0115 RFP 99-56
- -----------------------------------------------------------------------------------------------------------------------------------
<S> <C> <C> <C> <C>
AWARD/CONTRACT 1. THIS CONTRACT IS A RATED ORDER RATING PAGE OF PAGES
UNDER DPAS (15 CFR 350) 1 17
- -----------------------------------------------------------------------------------------------------------------------------------
2. CONTRACT (Proc. inst. ident.) No. 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQUEST/PROJECT NO.
N01-AO-02734 See Item 20C. 001971
- -----------------------------------------------------------------------------------------------------------------------------------
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
- -----------------------------------------------------------------------------------------------------------------------------------
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
-------------------------------------------
10. SUBMIT INVOICES ITEM
(4 copies unless other-
wise specified) TO THE 5.
- ---------------------------------------------------------------------------------------- ADDRESS SHOWN IN
CODE FACILITY CODE
- -----------------------------------------------------------------------------------------------------------------------------------
11. SHIP TO/MARK FOR 12. PAYMENT WILL BE MADE BY CODE
See Sect. F, Article F.2. See Article G.3.
- -----------------------------------------------------------------------------------------------------------------------------------
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
- -----------------------------------------------------------------------------------------------------------------------------------
15A. ITEM NO. 15B. SUPPLIES/SERVICES 15C. QUANTITY 15D. UNIT 15E. UNIT PRICE 15F. AMOUNT
- -----------------------------------------------------------------------------------------------------------------------------------
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
- -----------------------------------------------------------------------------------------------------------------------------------
15G. TOTAL AMOUNT OF CONTRACT $10,798,411
- -----------------------------------------------------------------------------------------------------------------------------------
<CAPTION>
16. TABLE OF CONTENTS
- -----------------------------------------------------------------------------------------------------------------------------------
<S> <C> <C> <C> <C> <C> <C> <C>
(x) SEC. DESCRIPTION PAGE(S) (x) SEC. DESCRIPTION PAGE(S)
- -----------------------------------------------------------------------------------------------------------------------------------
PART I - THE SCHEDULE PART II - CONTRACT CLAUSES
- -----------------------------------------------------------------------------------------------------------------------------------
x A SOLICITATION/CONTRACT FORM 1 x I CONTRACT CLAUSES 11
- -----------------------------------------------------------------------------------------------------------------------------------
x B SUPPLIES OR SERVICES AND PRICES/COSTS 3 PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH
- -----------------------------------------------------------------------------------------------------------------------------------
x C DESCRIPTION/SPECS./WORK STATEMENT 4 x J LIST OF ATTACHMENTS 16
- -----------------------------------------------------------------------------------------------------------------------------------
x D PACKAGING AND MARKING 5 PART IV - REPRESENTATIONS AND INSTRUCTIONS
- -----------------------------------------------------------------------------------------------------------------------------------
x E INSPECTION AND ACCEPTANCE 5
- --------------------------------------------------------------- x K REPRESENTATIONS, CERTIFICATIONS AND 17
x F DELIVERIES OR PERFORMANCE 6 OTHER STATEMENTS OF OFFERORS
- -----------------------------------------------------------------------------------------------------------------------------------
x G CONTRACT ADMINISTRATION DATA 7 L INSTRS., CONDS., AND NOTICES TO OFFERORS
- -----------------------------------------------------------------------------------------------------------------------------------
x H SPECIAL CONTRACT REQUIREMENTS 9 M EVALUATION FACTORS FOR AWARD
- -----------------------------------------------------------------------------------------------------------------------------------
<CAPTION>
CONTRACTING OFFICER WILL COMPLETE ITEM 17 OR 18 AS APPLICABLE
- -----------------------------------------------------------------------------------------------------------------------------------
<S> <C>
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.)
- -----------------------------------------------------------------------------------------------------------------------------------
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
- -----------------------------------------------------------------------------------------------------------------------------------
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)
- -----------------------------------------------------------------------------------------------------------------------------------
</TABLE>
<PAGE>
DETAILED TABLE OF CONTRACT CONTENTS
<TABLE>
<CAPTION>
PART I - THE SCHEDULE
<S> <C>
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
</TABLE>
2
<PAGE>
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
<PAGE>
(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
<PAGE>
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
<PAGE>
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:
<TABLE>
<CAPTION>
Item Quantity Delivery Schedule
---- -------- -----------------
<S> <C> <C> <C>
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
</TABLE>
c. The above items shall be addressed and delivered to:
<TABLE>
<CAPTION>
Addressee Deliverable Item No. Quantity
---------- -------------------- --------
<S> <C> <C>
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
</TABLE>
6
<PAGE>
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
<PAGE>
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
<PAGE>
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
<PAGE>
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
[email protected] 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
<PAGE>
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:
<TABLE>
<CAPTION>
FAR
CLAUSE
NO. DATE TITLE
------ ---- -----
<S> <C> <C>
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
</TABLE>
11
<PAGE>
<TABLE>
<CAPTION>
<S> <C> <C>
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)
</TABLE>
12
<PAGE>
<TABLE>
<CAPTION>
<S> <C> <C>
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
</TABLE>
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
<PAGE>
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
<PAGE>
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
<PAGE>
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
<PAGE>
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
<PAGE>
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
<PAGE>
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
<PAGE>
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
<PAGE>
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
<PAGE>
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
<PAGE>
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
<PAGE>
(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
<PAGE>
(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
<PAGE>
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
<PAGE>
SAMPLE INVOICE/FINANCING REQUEST AND CONTRACT FINANCIAL REPORT
<TABLE>
=================================================================================================================================
<S> <C>
(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 ___________
=================================================================================================================================
</TABLE>
<TABLE>
<CAPTION>
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
- ---------------------------------------------------------------------------------------------------------------------------------
<S> <C> <C> <C> <C> <C> <C> <C>
(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
=================================================================================================================================
=================================================================================================================================
</TABLE>
NIH(RC)-4 ATTACHMENT 2
Rev. 5/97 Page 5
5
<PAGE>
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
<PAGE>
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
<PAGE>
GOVERNMENT PROPERTY
SCHEDULE II-A
N01-AO-02734
<TABLE>
<CAPTION>
NIH Property Number Item Count
- ------------------- ---- -----
<S> <C> <C>
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
</TABLE>
ATTACHMENT 5
29
<PAGE>
Cont. GOVERNMENT PROPERTY - SCHEDULE ii-A; N01-AO-02734 Page 2
<TABLE>
<CAPTION>
<S> <C> <C>
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
</TABLE>
Attachment 5
30
<PAGE>
EXHIBITS
(10) Goverment Contracts.
3. Title: Facility for Animals Used
in Infectious Disease
Research.
Institute: National Institute of
Allergy and Infectious
Diseases
Dates Funded: 3/1/00 - 2/28/07
<PAGE>
<TABLE>
<CAPTION>
STANDARD FORM 26 (REV. 4-85) NSN 7540-01-152-8069 OMB No. 0990-0115 RFP 99-56
- -----------------------------------------------------------------------------------------------------------------------------------
<S> <C> <C> <C> <C>
AWARD/CONTRACT 1. THIS CONTRACT IS A RATED ORDER RATING PAGE OF PAGES
UNDER DPAS (15 CFR 350) 1 15
- -----------------------------------------------------------------------------------------------------------------------------------
2. CONTRACT (Proc. inst. ident.) No. 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQUEST/PROJECT NO.
N01-AO-02735 See Item 20C. 001974
- -----------------------------------------------------------------------------------------------------------------------------------
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
- -----------------------------------------------------------------------------------------------------------------------------------
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
-------------------------------------------
10. SUBMIT INVOICES ITEM
(4 copies unless other-
wise specified) TO THE G.3.
- ---------------------------------------------------------------------------------------- ADDRESS SHOWN IN
CODE FACILITY CODE
- -----------------------------------------------------------------------------------------------------------------------------------
11. SHIP TO/MARK FOR 12. PAYMENT WILL BE MADE BY CODE
See Sect. F, Article F.2. See Article G.3.
- -----------------------------------------------------------------------------------------------------------------------------------
13. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION 14. ACCOUNTING AND APPROPRIATION DATA
N/A DOC #N1AO02735; OC 25.2E EIN #1133078199A2
CAN #0-8325797 Amt. $491,063
[ ] 10 U.S.C. 2304 (c)( ) [ ] 41 U.S.C. 253(c)( ) CAN #0-8335255 Amt. $312,000
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15A. ITEM NO. 15B. SUPPLIES/SERVICES 15C. QUANTITY 15D. UNIT 15E. UNIT PRICE 15F. AMOUNT
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Technical Support Services Contract
Title: Facility for Animals Used in Infectious Disease Research
Period: March 1, 2000 through February 28, 2007
Amount Allotted: $803,063
Contract Type: CPFF - Completion
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15G. TOTAL AMOUNT OF CONTRACT $6,298,647
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<CAPTION>
16. TABLE OF CONTENTS
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<S> <C> <C> <C> <C> <C> <C> <C>
(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 10
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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 14
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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 x K REPRESENTATIONS, CERTIFICATIONS AND 15
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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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<CAPTION>
CONTRACTING OFFICER WILL COMPLETE ITEM 17 OR 18 AS APPLICABLE
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<S> <C>
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
--------------------------------------- 2/29/00 --------------------------------------- 2/29/2000
(Signature of person authorized to sign) (Signature of Contracting Officer)
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</TABLE>
<PAGE>
DETAILED TABLE OF CONTRACT CONTENTS
<TABLE>
<CAPTION>
PART I - THE SCHEDULE
<S> <C>
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............................................... 4
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.................................... 6
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... 7
Article G.4. Indirect Costs Rates................................................. 8
Article G.5. Government Property.................................................. 8
Article G.6. Post Award Evaluation of Past Performance............................ 8
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....................................................... 9
Article H.5. Reporting Matters Involving Fraud, Waste and Abuse................... 9
PART II - CONTRACT CLAUSES............................................................. 10
SECTION I - CONTRACT CLAUSES......................................................... 10
Article I.1. General Clauses for a Cost Reimbursement Service Contract............ 10
Article I.2. Authorized Substitutions of Clauses.................................. 12
Article I.3. Additional Contract Clauses.......................................... 12
Article I.4. Additional FAR Contract Clauses Included in Full Text................ 13
PART III LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS............................. 14
SECTION J - LIST OF ATTACHMENTS...................................................... 14
PART IV REPRESENTATIONS AND INSTRUCTIONS............................................... 15
SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS
OF OFFERER........................................................................... 15
</TABLE>
2
<PAGE>
PART I - THE SCHEDULE
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 68 Old World and/or
New World nonhuman primates, in addition to an estimated 6 chimpanzees and 12
small animals (e.g. rabbits) at all times. Conduct an estimated 12 procedures
per year designed by the Project Officer, each utilizing approximately 24
monkeys. As required by the Project Officer, conduct an estimate of four
procedures per year with six chimpanzees. Additionally, a small number (less
than 4) of procedures shall be conducted on small animals (e.g. rabbits,
ferrets) when specified by the Project Officer. Procedures will be conducted
according to individual working protocols issued by NIAID Scientists. The
nature of investigations being conducted by NIAID scientists are long-term,
overlapping, labor intensive studies which will necessitate that the contractor
maintain individual animals for periods longer than 12 months (see STATEMENT OF
WORK, ATTACHMENT 1).
ARTICLE B.2. ESTIMATED COST AND FIXED FEE
a. The estimated cost of this contract is $5,859,207.
b. The fixed fee for this contract is $439,440. 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 $6,298,647.
d. Total funds currently available for payment and allotted to this contract are
$803,063 of which $747,036 represents the estimated costs, and of which
$56,027 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 2/28/2001.
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) Foreign travel;
(6) Consultant Costs
(7) Subcontracts
(8) Patient care costs;
(9) 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.
(10) Printing Costs (as defined in the Government Printing and Binding
Regulations).
3
<PAGE>
(11) Research Funding
ARTICLE B.4. ADVANCE UNDERSTANDINGS
(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) Overtime (premium) pay costs shall not exceed a total of $45,496 unless
prior approval is granted by the Contracting Officer via a Contract
modification.
(4) 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. Animal Enclosure (caging) costs
shall not exceed a total of $200,938 unless prior approval is granted by
the Contracting Officer via a Contract Modification.
(5) Fringe Benefits, Overhead and G&A rates, as proposed in Bioqual,
Incorporated Final Revised Offer, dated February 8, 2000, 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.
(6) The "Special test equipment" (see FAR Subpart 45.1) listed in the
Government Property Schedule II-A is hereby transferred to this contract
from predecessor Contract No. N01-AO-52706. This property is of
significant aggregate value and necessary for contract performance.
Contractor shall maintain and report inventory of this Special test
equipment in a "Summary Record" in accordance with FAR Subpart 45.5. Title
to this property shall remain with the Government.
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 below (see SECTION J,
ATTACHMENT 1, dated 3/1199), attached hereto and made a part if this
Contract:
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 - 3 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.
4
<PAGE>
(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
In most cases, clinical specimens designated by the Project Officer will be
collected and shall be frozen to -70C until delivered on dry ice. In some
instances, clinical specimens shall be drawn fresh daily from the animal(s) and
delivered intact, on wet ice, within 2 to 4 hours of being drawn from the
animal, but no later than 1:00 P.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
Frozen samples are to be shipped on dry ice in a styrofoam container. Fresh
samples are to be 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 Infectious Diseases, NIAID
Building 7, Room 106
9000 Rockville Pike
Bethesda, MD 20892
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 Infectious Diseases, NIAID
Building 7, Room 106
9000 Rockville Pike
Bethesda, Maryland 20892.
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).
5
<PAGE>
SECTION F - DELIVERIES OR PERFORMANCE
ARTICLE F.1. PERIOD OF PERFORMANCE
The period of performance of this contract shall be from March 1 2000 through
February 28, 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:
<TABLE>
<CAPTION>
Item Quantity Delivery Schedule
---- -------- -----------------
<S> <C> <C> <C>
a) Monthly Reports 3 10 Days after end of Month
b) Draft Final Report 3 15 Days after end of Contract
c) Final Report 6 15 Days after Project Officer's approval
of Draft Report
d) Summary of Salient Results 6 On or before the expiration date of the
contract
</TABLE>
c. The above items shall be addressed and delivered to:
<TABLE>
<CAPTION>
Addressee Deliverable Item No. Quantity
--------- -------------------- --------
<S> <C> <C>
Project Officer, LID,NIAID (a) 1
Bldg. 7, Rm. 106 (b) 2
9000 Rockville Pike (c) 2
Bethesda, MD 20892 (d) 5
Ivan Hernandez, Contracts (a) 2
Specialist, NIAID, NIH (b) 1
6700-B Rockledge Dr., Rm. 1127 (c) 1
Bethesda, MD 20892-7605 (d) 1
</TABLE>
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:
Laboratory of Infectious Diseases, NIAID
Building 7, Room 106
9000 Rockville Pike
Bethesda, MD 20892
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/.
6
<PAGE>
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. Brian Murphy
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
Marissa St. Claire Veterinarian
Boris Skopets Veterinarian
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:
Contract Specialist
Acquisitions Management and Operations Branch
National Institute of Allergy and Infectious Diseases
National Institutes of Health
6700-B Rockledge Drive, Room 1127
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.
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<PAGE>
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 Executive Blvd, Room 641E
Bethesda, MD 20892-7670
(301) 496-6466
b. Government Furnished Property - Schedule II-A
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-52706, 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.
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<PAGE>
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 106-113 Section 505; Federal Fiscal Year 2000
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.
ARTICLE H.5. 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. P.L. 106-113 Section 507; Federal Fiscal Year 2000
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
[email protected] 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)
9
<PAGE>
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:
<TABLE>
<CAPTION>
FAR
CLAUSE
NO. DATE TITLE
------ ---- -----
<S> <C> <C>
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
52.216-8 Mar 1997 Fixed Fee
</TABLE>
10
<PAGE>
<TABLE>
<CAPTION>
<S> <C> <C>
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)
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.
</TABLE>
11
<PAGE>
<TABLE>
<CAPTION>
<S> <C> <C>
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
</TABLE>
b. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48
CFR CHAPTER 3) CLAUSES.
<TABLE>
<CAPTION>
HHSAR
CLAUSE
NO. DATE TITLE
------ ---- -----
<S> <C> <C>
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
</TABLE>
[End of GENERAL CLAUSES FOR A COST-REIMBURSEMENT SERVICE CONTRACT - Rev.
10/1999].
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 1997) 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 (Apr 1984), is deleted in its entirety and FAR
52.232-22, LIMITATION OF FUNDS (APRIL 1984) is substituted therefor.
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
(1) FAR 52.217-2, Cancellation Under Multiyear Contract (July 1996).
(2) FAR 52.219-6, Notice of Total Small Business Set-Aside (July 1996).
(3) FAR 52.219-14, Limitation on Subcontracting (Dec 1996)
(4) FAR 52.223-3, Hazardous Material Identification and Material Safety Data
(JANUARY 1997), ALTERNATE I (JULY 1995)
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<PAGE>
(5) FAR 52.227-17, Rights in Data--Special Works (JUNE 1987).
(6) FAR 52.237-3, Continuity of Services (JANUARY 1991).
(7) 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).
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.
13
<PAGE>
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, 4 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 pages.
4. Procurement of Certain Equipment, NIH(RC)-7, (OMB Bulletin 81-16), April
1984, 1 page.
5. Disclosure of Lobbying Activities, OMB Form SF-LLL, December, 1989, 3 pages.
6. Government Property - Schedule II-A
14
<PAGE>
PART IV
SECTION K - REPRESENTATIONS AND CERTIFICATIONS (Negotiated).
The following documents are incorporated by reference in this contract:
1. Representations and Certifications, dated November 8, 1999.
2. Certificate of Current Costs or Pricing Data (FAR 15.406-2), dated 2/8/2000.
3. Animal Welfare Assurance Number A3086-01.
15
<PAGE>
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.
A. Specifically, the Contractor shall:
1. House, feed and care for an estimated 68 Old World and/or New World non-
human primates, in addition to an estimated 6 chimpanzees and 12 small
animals (e.g. rabbits) at all times. (Note to Offeror: The use of species
other than non-human primates will represent a small part (less than 2%)
of the level of effort for the Statement of Work. The Contractor must only
state their capability and willingness to accommodate species other than
non-human primates. No cost information for species other than non-human
primates is required. However, if the costs associated with work using
species other than non-human primates appear that they will exceed 2%,
fiscal accounting will be required.)
2. Conduct an estimate of 12 procedures per year designed by the Project
Officer, each utilizing approximately 24 monkeys and one or more viruses,
that last generally one month in duration (occasionally two months).
Conduct an estimate of four procedures per year also designed by the
Project Officer with six chimpanzees that last form one to three months.
Alternatively, a small number (approximately 4 or less) of procedures
shall be conducted on small animals (e.g. rabbits, ferrets) when specified
by the Project Officer. Procedures will be conducted according to
individual working protocols issued under NIAID ACUC approved Animal Study
Proposals. Viruses to be tested include, but are not limited to, the
following:
a. Wild type and attenuated parainfluenza, respiratory syncytial,
influenza A and B viruses, and measles virus.
b. Vaccinia wild type and recombinant viruses.
c. Attenuated and wild type adenoviruses, including recombinant
adenovirus.
d. Rotaviruses.
e. Norwalk-like viruses.
f. Flaviviruses.
3. Administer new therapies such as antiviral agents and immunotherapies and
record their effectiveness against viral infection and collect specimens
as described in protocols furnished by the Project Officer.
Produce polyclonal antibodies in SPF rabbits under conditions of isolation
to prevent the acquisition of adventitious pathogens by the rabbit. The
method for production of the polyclonal antibodies will be the creation of
whiffle-ball chambers by surgical implantation, two per rabbit (Clemons,
et al. Evaluation of a subcutaneously implanted chamber for antibody
production in rabbits. Laboratory Animal Science 42: 307-311)
Monkeys will be pre-conditioned for use on experimental protocols
following arrival and during quarantine. Post-study animals will be held
(generally 1-4 weeks) until disposition and transportation are arranged by
the Government.
The performance of specialized tests on specimens collected by the
Contractor shall be the responsibility of Government scientists. However
the costs associated with collection of specimens such as blood, samples
for virus isolation, and specimens for pathologic observations shall be
the responsibility of the Contractor. It is estimated that the following
shall be required:
a. Five (5) blood specimens per animal.
b. Ten (10) nasopharyngeal swabs per animal.
c. Four (4) tracheal lavages per animal.
d. Up to 1,000 pathologic specimens (total).
In some instances, clinical specimens, drawn fresh daily from the animal,
shall be delivered intact, on wet ice, to NIH, Building 7, Respiratory
Viruses Section, within 2 to 4 hours after having been drawn, by 1:00 P.M.
on the day obtained in order to achieve optimal and maximum virus
isolation and recovery rates. In most procedures, specimens shall be
frozen at -70C until delivery on dry ice.
Statement of Work (3/11/99) ATTACHMENT 1
4. Physical Plant:
a. Biosafety Level: ABSL-2 practices, containment equipment, and facilities
are required for activities using non-human primates
16
<PAGE>
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.
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.
5. Animal Environment, Housing, and Management:
a. Caging Specifications:
(1) 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 are essential for hepatitis virus research.
(2) Chimpanzee housing shall be of a design that provides biocontainment
as well as an enriched environment including an adjacent exercise
area. Specifically, the air handling shall prevent the acquisition of
viruses, especially respiratory viruses, by the chimpanzees from
their animal handlers and vice versa. The primary enclosure shall be
at least 25 sq. ft. of floor space with an internal height of 84
inches. An adjacent exercise area shall be at least 35 sq. ft. of
floor space with an interior height of 84 inches. The primary
enclosure shall be equipped with a squeeze mechanism to gain control
of the chimpanzee for injections or to persuade the chimpanzee to
enter a transfer cage. The primary enclosure shall have an adjacent
service area door that can be closed when the chimpanzee is being
manipulated. When required, chimpanzees shall be individually housed
with exclusive access to both a primary enclosure area and an
exercise area. Individually housed chimpanzees shall have visual
contact with conspecifics. These enclosures shall be designed to be
washed and disinfected in place.
Statement of Work (3/11/99) ATTACHMENT 1
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
3
<PAGE>
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.
d. Medical Pathological Waste (MPW): The disposition of potentially infected
materials shall be accomplished, sequentially, in the following manner:
(1) 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.
e. Environmental Enrichment: The Contractor shall provide plans for enriching
the environment of non-human primates.
f. 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. Chimpanzees shall be
fed four times daily consisting of standard biscuit ration plus three
rations of a variety of fruit and vegetables, distributed throughout the
day.
g. 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; (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.
6. 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.
Statement of Work (3/11/99) ATTACHMENT 1
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).
7. Veterinary Medical Care:
4
<PAGE>
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. Necropsies will be
performed as needed.
B. 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. Biosafety in Microbiological and
Biomedical Laboratories (CDC-NIH 1993). e. 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).
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.
Statement of Work (3/11/99) ATTACHMENT 1
5
<PAGE>
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
6
<PAGE>
(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
7
<PAGE>
(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.
NIH (RC)-4 ATTACHMENT 2
Rev.5/97
8
<PAGE>
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
9
<PAGE>
SAMPLE INVOICE/FINANCING REQUEST AND CONTRACT FINANCIAL REPORT
<TABLE>
=================================================================================================================================
<S> <C>
(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 ___________
=================================================================================================================================
</TABLE>
<TABLE>
<CAPTION>
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
- ---------------------------------------------------------------------------------------------------------------------------------
<S> <C> <C> <C> <C> <C> <C> <C>
(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
=================================================================================================================================
=================================================================================================================================
</TABLE>
NIH(RC)-4 ATTACHMENT 2
Rev. 5/97 Page 5
5
<PAGE>
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)
10
<PAGE>
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
11
<PAGE>
DISCLOSURE OF LOBBYING ACTIVITIES Approved by OMB
0348-0046
Complete this form to disclose lobbying activities pursuant to 31 U.S.C. 1352
(See reverse for public burden disclosure.)
<TABLE>
<CAPTION>
- -----------------------------------------------------------------------------------------------------------------------
<S> <C> <C>
1. Type of Federal Action: 2. Status of Federal Action: 3. Report Type:
a. contract a. bid/offer/application a. initial filing
b. grant b. Initial award b. material change
c. cooperative agreement c. post-award For Material Change Only:
d. loan year _____ quarter _____
e. loan guarantee date of last report __________
f. loan insurance
<CAPTION>
- -----------------------------------------------------------------------------------------------------------------------
<S> <C>
4. Name and Address of Reporting Entity: 5. If Reporting Entity in No. 4 is Subawardee, Enter Name
and Address of Prime
[ ] Prime [ ] Subawardee
Tier _____, if known:
Congressional District, if known: Congressional District, if known:
- -----------------------------------------------------------------------------------------------------------------------
6. Federal Department/Agency: 7. Federal Program Name/Description
CFDA Number, if applicable:
- -----------------------------------------------------------------------------------------------------------------------
8. Federal Action Number, if known: 9. Award Amount, if known:
$
- -----------------------------------------------------------------------------------------------------------------------
10. a. Name and Address of Lobbying Entity b. Individual Performing Services (including address if
(if individual, last name, first name, MI): different from No. 10a)
(last name, first name, MI)
(attach Continuation Sheet(s) SF-LLL-A, if necessary)
- -----------------------------------------------------------------------------------------------------------------------
11. Amount of Payment (check all that apply): 13. Type of Payment (check all that apply):
$__________ [ ] actual [ ] planned [ ] a. retainer
[ ] b. one-time fee
- ----------------------------------------------------------- [ ] c. commission
12. Form of Payment (check all that apply): [ ] d. contingent fee
[ ] a. cash [ ] e. deferred
[ ] b. in-kind; specify: nature __________ [ ] f. other; specify: __________________________
value __________
- -----------------------------------------------------------------------------------------------------------------------
14. Brief Description of Services Performed or to be Performed and Date(s) of Service, including officer(s),
employee(s), or Member(s) contacted, for payment indicated in Item 11:
(attach Continuation Sheet(s) SF-LLL-A, if necessary)
- -----------------------------------------------------------------------------------------------------------------------
15. Continuation Sheet(s) SF-LLL-A attached: Yes No
- -----------------------------------------------------------------------------------------------------------------------
16. Information requested through this form is authorized by title 31 Signature:__________________________________
U.S.C. section 1352. This disclosure of lobbying activities is a
material representation of fact upon which reliance was placed by Print Name:_________________________________
the tier above when this transaction was made or entered into.
This disclosure is required pursuant to 31 U.S.C. 1352. This Title:______________________________________
information will be reported to the Congress semi-annually and
will be available for public inspection. Any person who fails to Telephone No.:_______________ Date:_________
file the required disclosure shall be subject to a civil penalty
of not less than $10,000 and not more than $100,000 for each
failure.
- -----------------------------------------------------------------------------------------------------------------------
Federal Use Only Authorized for Local Reproduction
Standard Form--LLL
- -----------------------------------------------------------------------------------------------------------------------
</TABLE>
Disclosure of Lobbying Activities 1 ATTACHMENT 5
<PAGE>
DISCLOSURE OF LOBBYING ACTIVITIES
CONTINUATION SHEET
Approved by OMB
0348-0046
Reporting Entity: Page of
------------------------------------------- ----- -----
Authorized for Local Reproduction
Standard Form--LLL-A
Disclosure of Lobbying Activities 2 ATTACHMENT 5
<PAGE>
INSTRUCTIONS FOR COMPLETION OF SF-LLL, DISCLOSURE OF LOBBYING ACTIVITIES
This disclosure form shall be completed by the reporting entity, whether
subawardee of prime Federal recipient, at the initiation or receipt of a covered
Federal action, or a material change to a previous filing, pursuant to title 31
U.S.C. section 1352. The filing of a form is required for each payment or
agreement to make payment to any lobbying entity for influencing of attempting
to influence an officer or employee of any agency, a Member of Congress, an
officer or employee of Congress, or an employee of a Member of Congress in
connection with a covered Federal action. Use the SF-LLL-A Continuation Sheet
for additional information if the space on the form is inadequate. Complete all
items that apply for both the initial filing and material change report. Refer
to the implementing guidance published by the Office of Management and Budget
for additional information.
1. Identify the type of covered Federal action for which lobbying activity is
and/or has been secured to influence the outcome of a covered Federal
action.
2. Identify the status of the covered Federal action.
3. Identify the appropriate classification of this report. If this is a follow-
up report caused by a material change to the information previously
reported, enter the year and quarter in which the change occurred. Enter the
date of the last previously submitted report by this reporting entity for
this covered Federal action.
4. Enter the full name, address, city, state and zip code of the reporting
entity. Include Congressional District, if known. Check the appropriate
classification of the reporting entity that designates if it is, or expects
to be, a prime or subaward recipient. Identify the tier of the subawardee,
e.g., the first subawardee of the prime is the 1st tier. Subawards include
but are not limited to subcontracts, subgrants and contract awards under
grants.
5. If the organization filing the report in item 4 checks "Subawardee," then
enter the full name, address, city, state and zip code of the prime Federal
recipient. Include Congressional District, if known.
6. Enter the name of the Federal agency making the award or loan commitment.
Include at least one organizational level below agency name, if known. For
example, Department of Transportation, United States Coast Guard.
7. Enter the Federal program name or description for the covered Federal action
(item 1). If known, enter the full Catalog of Federal Domestic Assistance
(CFDA) number for grants, cooperative agreements, loans, and loan
commitments.
8. Enter the most appropriate Federal identifying number available for the
Federal action identified in item 1 (e.g., Request for Proposal (RFP)
number, Invitation for Bid (IFB) number, grant announcement number, the
contract, grant, or loan award number, the application/proposal control
number assigned by the Federal agency). Include prefixes, e.g.,
"RFP-DE-90-001."
9. For a covered Federal action where there has been an award or loan
commitment by the Federal agency, enter the Federal amount of the award/loan
commitment for the prime entity identified in item 4 or 5.
10. (a) Enter the full name, address, city, state and zip code of the lobbying
entity engaged by the reporting entity identified in item 4 to influence
the covered Federal action.
(b) Enter the full names of the individual(s) performing services, and
include full address if different from 10(a); Enter Last Name, First
Name, and Middle Initial (MI).
11. Enter the amount of compensation paid or reasonably expected to be paid by
the reporting entity (item 4) to the lobbying entity (item 10). Indicate
whether the payment has been made (actual) or will be made (planned). Check
all boxes that apply. If this is a material charge report, enter the
cumulative amount of payment made or planned to be made.
12. Check the appropriate box(es). Check all boxes that apply. If payment is
made through an in-kind contribution, specify the nature and value of the
in-kind payment.
13. Check the appropriate box(es). Check all boxes that apply. If other,
specify nature.
14. Provide a specific and detailed description of the services that the
lobbyist has performed, or will be expected to perform, and the date(s) of
any services rendered. Include all preparatory and related activity, not
just time spent in actual contact with Federal officials. Identify the
Federal official(s) or employee(s) contacted or the officer(s), employee(s),
or Member(s) of Congress that were contacted.
15. Check whether or not a SF-LLL-A Continuation Sheet(s) is attached.
16. The certifying official shall sign and date the form, print his/her name,
title and telephone number.
Public reporting burden for this collection of information is estimated to
average 30 minutes per response, including time for reviewing instructions,
searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. Send comments regarding
the burden estimate or any other aspect of this collection of information,
including suggestions for reducing this burden, to the Office of Management and
Budget Paperwork Reduction Project (0348-0046), Washington, D.C. 20503.
Disclosure of Lobbying Activities 3 ATTACHMENT 5
<PAGE>
GOVERNMENT PROPERTY - SCHEDULE II-A
<TABLE>
<CAPTION>
Qty. Description Brand Model
- ---- ----------- ----- -----
<C> <S> <C> <C>
2 Biological hood/Safety cabinet Nu Aire 407-400
1 Light source for bronchoscope Oly Op CLE-4U
1 Scale
1 Bronchoscope
1 Refrigerator/Freezer Sears 46H64521N
1 Lift, mix & match Genie M-5
1 Suction Pump GOMCO GI4031
1 CO2 incubator OHIO MD
1 Electric Scale Arbor
1 Autoclave, 27" x 39" AMSCO VACAMATIC
1 Ultrasonic cleaning machine CRYOMED BRANSN 92
1 Dry ice Freezer REVCO SZB-659
1 Rectal biopsy kit
1 Freezer, -70 degree Puffer Hubbard
2 Primate cage, 4.3 sq. ft. Partco CG11
36 Isolation chamber, stainless steel Partco SMB 6010
13 4.3 sq. ft. cage, stainless steel Partco SMB 1025
24 4.0 sq. ft. cage, stainless steel Partco SMB 1025
40 Medium laryngoscope handle Welch Allyn (includes balde)
<CAPTION>
Special Test Equipment:
- -----------------------
<S> <C>
62 Handles 42 Rhesus monkey blades
18 Chimp blades 18 Squirrel monkey blades
</TABLE>
NIH-2043 ATTACHMENT 6
June 1982
12
<TABLE> <S> <C>
<PAGE>
<ARTICLE> 5
<LEGEND>
THIS SCHEDULE CONTAINS SUMMARY FINANCIAL INFORMATION EXTRACTED FROM FORM 10-QSB
FOR THE QUARTERLY PERIOD ENDED FEBRUARY 29, 2000 AND IS QUALIFIED IN ITS
ENTIRETY BY REFERENCE TO SUCH FINANCIAL STATEMENTS.
</LEGEND>
<MULTIPLIER> 1
<CURRENCY> U.S. DOLLARS
<S> <C>
<PERIOD-TYPE> 9-MOS
<FISCAL-YEAR-END> MAY-31-2000
<PERIOD-START> JUN-01-1999
<PERIOD-END> FEB-29-2000
<EXCHANGE-RATE> 1
<CASH> 71,185
<SECURITIES> 0
<RECEIVABLES> 1,938,143
<ALLOWANCES> 0
<INVENTORY> 256,790
<CURRENT-ASSETS> 2,040,324
<PP&E> 4,489,377
<DEPRECIATION> 2,872,215
<TOTAL-ASSETS> 4,893,687
<CURRENT-LIABILITIES> 1,379,184
<BONDS> 0
0
0
<COMMON> 16,004
<OTHER-SE> 3,493,841
<TOTAL-LIABILITY-AND-EQUITY> 4,893,687
<SALES> 94,809
<TOTAL-REVENUES> 8,564,407
<CGS> 76,932
<TOTAL-COSTS> 8,408,720
<OTHER-EXPENSES> 134,818
<LOSS-PROVISION> 0
<INTEREST-EXPENSE> 41,994
<INCOME-PRETAX> 76,455
<INCOME-TAX> 31,000
<INCOME-CONTINUING> 45,455
<DISCONTINUED> 0
<EXTRAORDINARY> 0
<CHANGES> 0
<NET-INCOME> 45,455
<EPS-BASIC> .05
<EPS-DILUTED> .05
</TABLE>
