================================================================================
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-Q
(Mark One)
[X] Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange
Act of 1934
For the quarterly period ended June 30, 1998, or
-------------
[ ] Transition Report Pursuant to Section 13 or 15(d) of the Securities
Exchange Act of 1934
For the transition period from _________________ to __________________
Commission file number 000-21615
------------
BOSTON BIOMEDICA, INC.
(Exact name of Registrant as Specified in its Charter)
Massachusetts 04-2652826
- ------------------------ ----------------------
(State or other (I.R.S. Employer
Jurisdiction of Identification No.)
Incorporation or
Organization)
375 West Street,
West Bridgewater,
Massachusetts 02379-1040
- ------------------------ ----------------------
(Address of Principal (Zip Code)
Executive Offices)
Registrant's telephone number, including area code (508) 580-1900
--------------
Indicate by check whether the registrant: (1) has filed all reports required
to be filed by Section 13 or 15(d) of the Securities 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 [ ]
The number of shares outstanding of the Registrant's only class of common
stock as of July 31, 1998 was 4,665,426.
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<PAGE>
Part I. Financial Information
Item 1. Financial Statements
BOSTON BIOMEDICA, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF INCOME
(Unaudited)
<TABLE>
<CAPTION>
For the Three Months Ended For the Six Months Ended
June 30, June 30,
-------------------------- -------------------------
1998 1997 1998 1997
------------ ------------ ------------ -----------
REVENUE:
<S> <C> <C> <C> <C>
Products $3,316,804 $2,416,956 $ 6,380,163 $4,543,912
Services 3,066,328 2,231,998 6,275,764 4,314,091
------------ ------------ ------------ -----------
Total revenue 6,383,132 4,648,954 12,655,927 8,858,003
COSTS AND EXPENSES:
Cost of product sales 1,674,837 1,271,662 3,446,588 2,327,084
Cost of services 1,999,019 1,456,194 4,322,230 2,931,726
Research and development 583,592 256,995 1,015,981 493,745
Acquired research and development - - 850,000 -
Selling and marketing 926,015 775,594 1,854,627 1,388,954
General and administrative 983,075 694,875 2,013,011 1,374,082
------------ ------------ ------------ -----------
Total operating costs and expenses 6,166,538 4,455,320 13,502,437 8,515,591
Income (loss) from operations 216,594 193,634 (846,510) 342,412
Interest (expense) income, net (660) 99,184 22,899 196,670
------------ ------------ ------------ -----------
Income (loss) before income taxes 215,934 292,818 (823,611) 539,082
(Provision for) benefit from income taxes (82,055) (117,128) 312,972 (215,634)
------------ ------------ ------------ -----------
Net income (loss) $ 133,879 $ 175,690 $ (510,639) $ 323,448
============ ============ ============ ===========
Net income (loss) per share, basic $ 0.03 $ 0.04 $ (0.11) $ 0.07
Net income (loss) per share, diluted $ 0.03 $ 0.04 $ (0.11) $ 0.07
Number of shares used to calculate net income per share
Basic 4,652,519 4,403,277 4,642,343 4,391,715
Diluted 4,865,593 4,839,407 4,642,343 4,824,731
</TABLE>
See Notes to Consolidated Financial Statement
2
BOSTON BIOMEDICA, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(Unaudited)
June 30, December 31,
------------ ------------
1998 1997
------------ ------------
ASSETS
CURRENT ASSETS:
Cash and cash equivalents $ 123,527 $ 2,772,360
Accounts receivable, less allowances of
$579,142 in 1998 and $446,517 in 1997 5,563,699 5,558,710
Inventories 6,603,413 5,902,821
Prepaid expense and other 640,555 288,481
Deferred income taxes 378,458 328,562
------------ ------------
Total current assets 13,309,652 14,850,934
------------ ------------
Property and equipment, net 5,783,730 4,980,164
OTHER ASSETS:
Long term investment 1,482,500 1,482,500
Goodwill and other intangibles, net 2,126,745 2,212,220
Notes receivable and other 108,365 124,178
------------ ------------
3,717,610 3,818,898
------------ ------------
TOTAL ASSETS $22,810,992 $23,649,996
============ ============
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES:
Current maturities of long term debt $ 14,831 $ 14,878
Accounts payable 1,650,345 2,218,685
Accrued compensation 1,046,658 1,103,837
Accrued income taxes - 132,802
Other accrued expenses 585,486 498,247
Deferred revenue 884,317 1,249,024
------------ ------------
Total current liabilities 4,181,637 5,217,473
------------ ------------
LONG-TERM LIABILITIES:
Long term debt, less current liabilities 535,726 26,820
Deferred rent and other liabilities 321,503 189,117
Deferred income taxes 142,887 149,333
COMMITMENTS AND CONTINGENCIES
STOCKHOLDERS' EQUITY:
Common stock, $.01 par value; authorized
20,000,000 shares in 1998 and 1997;
issued and outstanding 4,660,426 in
1998 and 4,622,566 in 1997 46,604 46,226
Additional paid-in capital 16,101,296 16,029,049
Retained earnings 1,481,339 1,991,978
------------ ------------
Total stockholders' equity 17,629,239 18,067,253
------------ ------------
TOTAL LIABILITIES & STOCKHOLDERS' EQUITY $22,810,992 $23,649,996
============ ============
See Notes to Colsolidated Financial Statements
3
BOSTON BIOMEDICA, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
For the Six Months Ended
June 30,
-------------------------
1998 1997
----------- ------------
CASH FLOWS FROM OPERATING ACTIVITIES:
Net (loss) income $ (510,639) $ 323,448
Adjustments to reconcile net (loss) income to net
cash (used in) provided by operating activities:
Depreciation and amortization 607,252 353,843
Provision for doubtful accounts 103,036 77,781
Deferred rent and other liabilities 132,386 (53,916)
Deferred income taxes (56,342) (31,655)
Acquired research and development 850,000 -
Changes in operating assets and liabilities:
Accounts receivable (108,025) (51,366)
Other assets - (27,083)
Inventories (700,592) (380,593)
Prepaid expenses (352,074) (76,392)
Accounts payable (568,340) 83,043
Accrued compensation and other expenses (102,742) (402,705)
Deferred revenue (364,707) 274,938
----------- ------------
Net cash (used in) provided by operating
activities (1,070,787) 89,343
----------- ------------
CASH FLOWS FROM INVESTING ACTIVITIES:
Acquired research and development (850,000) -
Payments for additions to property and equipment (1,325,097) (839,364)
Purchase of intangible assets (246) -
Advances under notes receivable and other assets 15,813 (893,005)
Purchase of long term investment - (750,000)
----------- ------------
Net cash used in investing activities (2,159,530) (2,482,369)
----------- ------------
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from long term debt 508,906 -
Repayments of long-term debt (47) (6,255)
Proceeds of common stock issued 72,625 93,687
----------- ------------
Net cash provided by financing activities 581,484 87,432
----------- ------------
DECREASE IN CASH AND CASH EQUIVALENTS: (2,648,833) (2,305,594)
Cash and cash equivalents, beginning of period 2,772,360 8,082,642
----------- ------------
Cash and cash equivalents, end of period $ 123,527 $ 5,777,048
=========== ============
See Notes to Consolidated Financial Statements
4
BOSTON BIOMEDICA, INC AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(1) Basis of Presentation
- -------------------------
The accompanying unaudited consolidated financial statements have been
prepared in accordance with generally accepted accounting principles for the
interim financial information and with the instructions to Form 10-Q and
Article 10 of Regulation S-X. Accordingly, they do not include all of the
information and footnotes required by generally accepted accounting principles
for complete financial statements. In the opinion of management, all
adjustments (consisting of only normal recurring adjustments) considered
necessary for a fair presentation have been included. Operating results for the
six months ended June 30, 1998 are not necessarily indicative of the results
that may be expected for the year ending December 31, 1998. For further
information, refer to the consolidated financial statements and footnotes
thereto included in the annual report of Form 10-K filing for the fiscal year
ended December 31, 1997 for Boston Biomedica, Inc. and Subsidiaries ("the
Company" or "Boston Biomedica"). Certain prior years' amounts in the
consolidated financial statements may have been reclassified to conform to the
current year's presentation.
(2) Use of Estimates
- ---------------------
In conformity with generally accepted accounting principles, management
is required to make estimates and assumptions that affect the reported amounts
of assets, liabilities, revenues, and expenses for the periods presented. Such
estimates include reserves for uncollectable accounts receivable as well as the
net realizable value of its inventory. Actual results could differ from the
estimates and assumptions used by management.
(3) Inventories
- ----------------
Inventories consisted of the following:
June 30, December 31,
1998 1997
------------ ------------
Raw materials..........$2,170,155 $2,033,040
Work-in-process.........1,629,171 1,190,567
Finished goods..........2,804,087 2,679,214
------------ ------------
$6,603,413 $5,902,821
============ ============
(4) Comprehensive Income
- -------------------------
Statement of Financial Accounting Standards No. 130, "Reporting
Comprehensive Income" (SFAS 130) is effective for fiscal years beginning after
December 15, 1997. SFAS 130 requires that changes in comprehensive income be
shown in a financial statement that is displayed with the same prominence as
other financial statements. The Company adopted SFAS 130 in the first quarter
of fiscal year ended December 31, 1998. Adoption of this statement has had no
impact on the Company's consolidated financial position and results of
operations as comprehensive income (loss) is the same as net income (loss).
(5) Acquired Research and Development
- --------------------------------------
In March 1998, the Company acquired from BioSeq, Inc.("BioSeq"), the
sole and exclusive worldwide right to development stage technology, including
the use of BioSeq technical information, licensed processes and improvements to
develop, manufacture, market and sell or sublicense products or services in the
field of human in vitro immunodiagnostics. Under this agreement, the Company
will pay BioSeq an annual royalty based on net sales to customers and
sublicensees. The agreement is effective March 20, 1998 and ends on the date
the last patent expires, which is approximately 16 years. In accordance with
accounting standards for development stage technology, the purchase price,
minimum royalty payments and acquisition costs totaling $850,000, were expensed
in the first quarter.
5
BOSTON BIOMEDICA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(6) Computation of Net Income per Share
- ----------------------------------------
In February 1997, the Financial Accounting Standards Board issued
Statement of Financial Accounting Standards ("SFAS") No. 128, "Earnings per
Share". SFAS 128 establishes a different method of computing net income per
share than was required under the provisions of the previous
standard-Accounting Principles Board opinion No. 15. The following illustrates
the computation of basic and diluted net income per share.
Three Months Six Months
Ended June 30, Ended June 30,
---------------------- -----------------------
1998 1997 1998 1997
---------- ----------- ---------- ------------
Average common
stock outstanding 4,652,519 4,403,277 4,642,343 4,391,715
Net effect of dilutive
common stock equivalents-
based on treasury stock
method using average
market price * 213,074 436,130 - 433,016
---------- ----------- ---------- ------------
4,865,593 4,839,407 4,642,343 4,824,731
========== =========== ========== ============
Net income (loss) 133,879 175,690 (510,639 323,448
Net income (loss) per share 0.03 0.04 (0.11) 0.07
* Potentially dilutive securities of 228,875 were not included in the
computation of diluted earnings per share because to do so would have
been antidilutive for the six months ended June 30, 1998.
(7) Extension of Line of Credit
- --------------------------------
Effective June 30, 1998, the maturity date of the revolving line of
credit agreement was extended from June 30, 1999 to June 30, 2000. Accordingly,
the balance borrowed against the line as of June 30, 1998 is classified as long
term debt.
6
Item 2. Management's Discussion and Analysis of Results of Operations and
Financial Condition.
Three Months Ended June 30, 1998 and 1997
Total revenue increased 37.3%, or $1,734,000, to $6,383,000 for the
three months ended June 30, 1998 from $4,649,000 in the prior year period. This
increase was the result of an increase in product sales of 37.2%, or $900,000,
to $3,317,000 from $2,417,000 and an increase in specialty laboratory services
of 37.4%, or $834,000, to $3,066,000 from $2,232,000. The inclusion of BBI
Source Scientific ("Source") in the second quarter results added to product and
service revenue in the amounts of $614,000 and $392,000, respectively. The
remaining increase in product revenue was the result of significant increases
in Accurun(r) controls and OEM panel sales. The remaining increase in service
revenue was the result of a significant increase in billed labor on government
contracts for R&D services at the Company's new facility in Gaithersburg, MD.
The Company also realized increased revenue from immunology testing including
Hepatitis C and tickborne diseases.
Gross profit increased 41.0%, or $788,000, to $2,709,000 for the
current three months from $1,921,000 in the prior year period. Overall gross
margin increased to 42.4% from 41.3%. All of the increase was attributable to
product sales. The gross margin on products increased to 49.5% from 47.4%, as
the sales growth was in Accurun(r) and OEM panel products, which carry higher
margins.
Research and development expenses increased 127.1%, or $327,000, to
$584,000 for the current three months from $257,000 in the prior year period.
The increase is primarily the result of the inclusion of Source and its
development efforts in the laboratory instrumentation product line, including
the PlateMate( and reflectance reader projects. Also contributing to the
increase was additional spending on molecular tests and Quality Control
Products.
Selling and marketing expenses increased 19.4%, or $150,000, to
$926,000 for the current three months from $776,000 in the prior year period.
This increase was primarily the result of the first time inclusion of Source.
General and administrative expenses increased 41.5%, or $288,000, to
$983,000 for the current three months from $695,000 in the prior year period.
The inclusion of Source accounted for $173,000 of this increase. The remaining
increase relates to the addition of human resource, collection, and
administrative support personnel.
Net interest expense was $660 for the current quarter compared to net
interest income of $99,000 in the prior year period. The Company has
productively employed the proceeds from its initial public offering and, at the
end of the quarter, began to borrow funds under its line of credit to continue
its infrastructure investments.
Based on current tax planning, the Company provided taxes at the
combined federal and state statutory rate of 38% in the current quarter versus
40% in the prior year period.
Six Months Ended June 30, 1998 and 1997
Total revenue increased 42.9%, or $3,798,000, to $12,656,000 for the
six months ended June 30, 1998 from $8,858,000 in the prior year period. This
increase was the result of an increase in product sales of 40.4%, or
$1,836,000, to $6,380,000 from $4,544,000 and an increase in specialty
laboratory services of 45.5%, or $1,962,000, to $6,276,000 from $4,314,000. The
inclusion of Source added to product and service revenue in the amounts of
$1,081,000 and $1,124,000, respectively. The remaining increase in product
revenue is due to a doubling of Accurun(r) sales and a significant increase in
OEM panel sales. The remaining increase in specialty laboratory services is
attributable to an increase in clinical testing and contract research revenue.
Gross profit increased 35.8%, or $1,288,000, to $4,887,000 for the
current six months from $3,599,000 in the prior year period. The gross profit
margin decreased to 38.6% for the current six months versus 40.6% in the prior
year period. This is due primarily to lower margins on Source instruments and
the impact of higher fixed overhead at BBI Biotech as a result of its move to
its new facility in Gaithersburg, MD, both adversely affecting the first
quarter.
7
Research and development expenses increased 105.8%, or $522,000, to
$1,016,000 for the current six months from $494,000 in the prior year period.
The increase is primarily the result of the inclusion of Source's development
efforts for new laboratory instruments as well as additional spending on
molecular tests and Quality Control Products.
There was an accounting charge of $850,000, in the first quarter,
related to the acquisition of the worldwide exclusive rights to BioSeq Inc's
immunodiagnostic research and development technology as noted in footnote 5.
Selling and marketing expenses increased 33.5%, or $466,000, to
$1,855,000 for the current six months from $1,389,000 in the prior year period.
The inclusion of Source added $130,000. The remaining increase was
attributable to increased personnel costs associated with the expansion of the
TQS sales, marketing and technical support staff as well as additions to the
clinical laboratory sales staff.
General and administrative expenses increased 46.5%, or $639,000, to
$2,013,000 for the current six months from $1,374,000 in the prior year period.
This increase was a result of the first time inclusion of Source as well as
additional human resource, MIS, collection, and administrative support
personnel.
Net interest income decreased 88.3%, or $174,000 to $23,000 for the
current six months from $197,000 in the prior year period. The Company has
productively employed its proceeds from its initial public offering and, at the
end of the six month period, began to borrow funds from its revolving line of
credit to continue its infrastructure investments.
Based on current tax planning, the Company provided taxes at the
combined federal and state statutory rate of 38% in the current quarter versus
40% in the prior year period.
Liquidity and Financial Condition
At June 30, 1998, the Company had cash and cash equivalents of
approximately $124,000 and working capital of $9,128,000. Both of these items
have decreased significantly from year end as the Company continued its planned
capital expenditures.
The Company has financed its operations to date through cash flow from
operations, borrowings from banks and issuance of common stock. The Company
expects its cash flow, current cash position and its $7.5 million
uncollateralized revolving line of credit to meet its working capital needs.
Net cash used for operations for the six months ended June 30, 1998 was
($1,071,000) as compared to cash provided by operations of $89,000 in the prior
year period. This decrease in cash flow was primarily attributable to the net
loss for the period, increased purchases of strategic inventory for its Quality
Control Products, a reduction in current liabilities, and the delay, until
July, in settlement of a large receivable..
Cash used in investing activities for the six months ended June 30,
1998 was $2,160,000 as compared to $2,482,000 in the prior year period. The
cash used relates to the acquired BioSeq research and development as described
above, as well as continued improvements at its Massachusetts and Maryland
facilities.
Cash provided by financing activities for the six months ended June 30,
1998 was $581,000 as compared to $87,000 in the prior year period. The cash
received was from borrowing against the revolving line of credit and the
exercise of stock options during the period.
The Company anticipates capital expenditures for the expansion of the
West Bridgewater facility and additional improvements in its Maryland facility
as a result of recently awarded contracts to be completed by the end of 1998.
The Company also expects to replace its business information software over the
next twelve months at a cost of approximately $750,000. The Company believes
that existing cash balances, the borrowing capacity available under its
revolving line of credit and cash generated from operations are sufficient to
fund operations and
8
anticipated capital expenditures for the foreseeable future. Except for
purchase orders and contracts in connection with the expansion and the business
information software, there were no material financial commitments for capital
expenditures as of June 30, 1998.
Recent Accounting Pronouncements
Statement of Financial Accounting Standards No. 132, "Employers'
Disclosure about Pensions and Other Postretirement Benefits" (SFAS 132) is
effective for fiscal years beginning after December 15, 1997. SFAS 132 revises
employers' disclosures about pension and other postretirement benefit plans. It
does not change the measurement or recognition of those plans. The Company will
adopt SFAS 132 in the fiscal year ended December 31, 1998, although no impact
on operating results of financial position is expected.
Year 2000 Computer Systems Compliance
Concerns have been widely expressed regarding the inability of certain
computer programs to process date information beyond year 1999. These concerns
focus on the impact of the Year 2000 problem on business operations and the
potential costs associated with identifying and addressing the problem. The
Company is in the process of evaluating and taking steps to deal with the
potential impact of this problem in areas under its control, including its
products and sources of supply, as well as its operations management,
administration and financial systems.
Based on its review to date, the Company believes that its products are
"Year 2000 compliant." The Company has confirmed with existing software vendors
that year 2000 compliant versions either exist or will be available to upgrade
or replace its operations management, administrative and financial systems. The
Company plans to begin a program to survey major suppliers to determine the
status and schedule for their Year 2000 compliance. Where it believes that a
particular supplier's situation poses unacceptable risks, the Company plans to
identify an alternative source.
Based upon its review, the Company does not believe that the Year 2000
problem will have a material adverse effect on the Company. However, there can
be no assurances that failure to comply with Year 2000 by parties outside its
control will not have a material adverse affect on the Company.
Forward-Looking Statements
This Quarterly Report on Form 10-Q contains forward-looking statements
concerning the Company's financial performance and business operations. The
Company wishes to caution readers of this Quarterly Report on Form 10-Q that
actual results might differ materially from those projected in any
forward-looking statements.
Factors which might cause actual results to differ materially from
those projected in the forward-looking statements contained herein include the
following: inability of the Company to develop the end user market for quality
control products; inability of the Company to integrate the business of Source
Scientific, Inc. into the Company's business; inability of the Company to grow
the sales of Source Scientific, Inc. to the extent anticipated; the renewal and
full funding of contracts with National Institutes of Health (NIH), National
Heart, Lung and Blood Institute (NHLBI) and other government agencies; a
material adverse change in the business, financial condition or prospects of
BioSeq, Inc., an early stage biotechnology company in which the Company has
made a significant investment, including inability to develop its technology to
the level of commercial utilization; inability of the Company to obtain an
adequate supply of the unique and rare specimens of plasma and serum necessary
for certain of its products; significant reductions in purchases by any of the
Company's major customers; and the potential insufficiency of Company
resources, including human resources, plant and equipment and management
systems, to accommodate any future growth. Certain of these and other factors
which might cause actual results to differ materially from those projected are
more fully set forth under the caption "Risk Factors" in the Company's
Registration Statement on Form S-1 (SEC File No. 333-10759).
9
BOSTON BIOMEDICA, INC.
Part II. Other Information
Item 4. Submission of Matters to a Vote of Security Holders.
The Company held its Annual Meeting of Stockholders of May 21, 1998
(the"Meeting"). A total of 3,749,521 shares, or 81%, of the Common Stock issued
and outstanding as of the record date, were represented at the meeting in
person or by proxy. At the Meeting, the only matter to be acted upon was the
election of directors. The results of the election were as follows:
Henry Malkasian was elected as a Class II Director of the Company, to
serve as such until the Year 2001 Annual Meeting of Stockholders and
until his successor has been duly elected and qualified:, with
3,732,115 shares voting in favor, 17,406 votes withheld.
The terms of office of Richard T. Schumacher, Kevin W. Quinlan, Calvin
A. Saravis, and Francis E. Capitanio, continued after the Meeting.
Item 6. Exhibits and Reports on Form 8-K
(a) Exhibits
Exhibit No. Reference
----------- ---------
3.1 Amended and Restated Articles of Organization
of the Company A**
3.2 Amended and Restated Bylaws of the Company A**
4.1 Specimen Certificate for Shares of the Company's
Common Stock A**
4.2 Description of Capital Stock (contained in the
Restated Articles of Organization of the
Company filed as Exhibit 3.1) A**
10.1 Contract, dated July 1, 1998, between the
National Institutes of Health and the Company
(NO1-AI-85341) Filed herewith
10.2 Contract, dated June 15, 1998, between the
National Heart Lung and Blood Institute and the
Company (NO1-HB-87144) Filed herewith
21.1 Subsidiaries of the Company B**
27 Financial Data Schedule Filed herewith
_______________________
A Incorporated by reference to the Company's Registration Statement on
Form S-1 (Registration No. 333-10759)(the "Registration Statement").
The number set forth herein is the number of the Exhibit in said
registration statement.
B Incorporated by reference to the Company's Annual Report on Form 10K
for the fiscal year ended December 31, 1997.
** In accordance with Rule 12b-32 under the Securities Exchange Act of
1934, as amended, reference is made to the documents previously filed
with the Securities and Exchange Commission, which documents are hereby
incorporated by reference.
(b) Reports on Form 8-K
None
10
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
the Registrant has duly caused this Report to be signed on its behalf by the
undersigned, thereunto duly authorized.
BOSTON BIOMEDICA, INC.
Date: August 14, 1998 By /s/ KEVIN W. QUINLAN
--------------- ---------------------------
Kevin W. Quinlan, Chief Financial Officer
(Principal Financial Officer)
11
<TABLE> <S> <C>
<ARTICLE> 5
<S> <C>
<PERIOD-TYPE> 6-MOS
<FISCAL-YEAR-END> DEC-31-1998
<PERIOD-END> JUN-30-1998
<CASH> 123,527
<SECURITIES> 0
<RECEIVABLES> 6,142,841
<ALLOWANCES> 579,142
<INVENTORY> 6,603,413
<CURRENT-ASSETS> 13,309,652
<PP&E> 8,975,008
<DEPRECIATION> 3,191,278
<TOTAL-ASSETS> 22,810,992
<CURRENT-LIABILITIES> 4,181,637
<BONDS> 535,726
0
0
<COMMON> 16,147,900
<OTHER-SE> 0
<TOTAL-LIABILITY-AND-EQUITY> 22,810,992
<SALES> 6,380,163
<TOTAL-REVENUES> 12,655,927
<CGS> 3,446,588
<TOTAL-COSTS> 13,502,437
<OTHER-EXPENSES> 0
<LOSS-PROVISION> 0
<INTEREST-EXPENSE> 0
<INCOME-PRETAX> (823,611)
<INCOME-TAX> (312,972)
<INCOME-CONTINUING> 0
<DISCONTINUED> 0
<EXTRAORDINARY> 0
<CHANGES> 0
<NET-INCOME> (510,639)
<EPS-PRIMARY> (0.11)
<EPS-DILUTED> (0.11)
</TABLE>
Contract No. N01-AI-85341
SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS
- -------------------------------------------------
ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES
- -------------------------------------------------------
This Contract will provide for the performance of standrdized virologic assays
to detect HIV-1 infection, as well as immunologic assays to assess
vaccine-induced HIV-specific humoral immune responses. These assays will be
conducted on specimens from volunteers in NIAID-sponsored AIDS vaccine or other
prevention intervention trials. Comparative assays with specimens from
HIV-infected individuals or volunteers in non-NIAID-sponsored trials of
candidate AIDS vaccines or other prevention measures will also be done. The
virological and immunological assay data will be transmitted to the AIDS
Vaccine Evaluation Group (AVEG) or HIV Network for Prevention Trials (HIVNET)
Statistical and Coordinating Center for further analysis. The Principal
Investigator and Co-Investigator(s) will collaborate in the design and
development of Clinical Trial Protocols, providing scientific leadership
regarding the differentiation of vaccine-induced antibody responses from HIV
infection-induced antibody responses and the evaluation of vaccine
immunogenicity.
ARTICLE B.2. ESTIMATED COST AND FIXED FEE
- ------------------------------------------
a. The estimated cost of this contract is $ .
----------
b. The fixed fee for this contract is $ . 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 fixed fee, is $9,417,245.
----------
d. Total funds currently available for payment and allotted to this contract
are $1,298,329, of which $1,229,656 represents the estimated costs, and of
---------- ----------
which $68,673 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 June 30, 1999.
-------------
f. The Contracting Officer may allot additional funds to the contract without
the concurrence of the Contractor.
g. Increments to be allotted to this contract are as follows:
Period Amount
7/1/98 - 6/30/99 $ 1,298,329
7/1/99 - 6/30/00 $ 1,244,773
7/1/00 - 6/30/01 $ 1,270,355
7/1/01 - 6/30/02 $ 1,308,439
7/1/02 - 6/30/03 $ 1,393,138
7/1/03 - 6/30/04 $ 1,429,682
7/1/04 - 6/30/05 $ 1,472,529
----------------
TOTAL $ 9,417,245
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, unless authorized in writing by the
Contracting Officer, the costs of the following items or activities shall
be unallowable as direct costs:
1
Contract No. N01-AI-85341
(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 (a general scientific
meeting is defined as an assemblage of scientific/technical personnel held
to exchange information and ideas through a scheduled program of
presentations; includes conferences, congresses, seminars, symposia and
workshops; usually sponsored by a national organization);
(5) Foreign travel - See Paragraph b. below;
(6) Overtime premium;
(7) Consultant fees;
(8) Subcontracts;
(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)Patient care costs
b. Travel Costs
------------
(1) Domestic Travel
---------------
(a) Total expenditures for domestic travel (transportation, lodging,
subsistence, and incidental expenses) incurred in direct
performance of this contract shall not exceed $45,844 without the
-------
prior written approval of the Contracting Officer.
(b) The Contractor shall invoice and be reimbursed for all travel costs
in accordance with Federal Acquisition Regulations (FAR) 31.205-46.
(2) Foreign Travel
--------------
Requests for foreign travel must be submitted at least six weeks in
advance and shall contain the following: (a) meeting(s) and place(s) to
be visited, with costs and dates; (b) name(s) and title(s) of
Contractor personnel to travel and their functions in the contract
project; (c) contract purposes to be served by the travel; (d) how
travel of contractor personnel will benefit and contribute to
accomplishing the contract project, or will otherwise justify the
expenditure of NIH contract funds; (e) how such advantages justify the
costs for travel and absence from the project of more than one person
if such are suggested; and (f) what additional functions may be
performed by the travelers to accomplish other purposes of the contract
and thus further benefit the project.
(3) Government Discount Air Travel Rates
------------------------------------
(a) To the maximum extent practicable consistent with travel
requirements, the Contractor agrees to use the reduced air
transportation rates and services provided through available
Government discount air fares. These fares are available only for
bona-fide employees' travel that is otherwise reimbursable as a
direct cost
2
Contract No. N01-AI-85341
pursuant to this contract. The objective is to achieve
the lowest overall cost to the Contractor and, thus, to the
Government. The Contractor shall submit written requests to the
Contracting Officer for authorization to use these rates. The
request shall provide the full name of the traveler(s), the number
of the contract for which the travel is being performed, the
contract objective that is to be fulfilled, and the dates during
which the travel is to occur.
Contracting Officer approval, if given, will be on official agency
letterhead so that the letter can be presented to airline as
confirmation of the authorization.
(b) Nothing in this clause shall authorize transportation or services
which are not otherwise reimbursable under this contract. Nothing
in this clause requires air carriers to make available to the
Contractor any government discount airfares.
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.
a. Indirect Costs
--------------
(1) In no event shall the final amount reimbursable for Overhead exceed a
ceiling of % of total direct labor in contract years 1-4 and %
------ ----
in contract years 5-7. In no event shall the final amount reimbursable
for General and Administrative expense exceed a ceiling of % of
---
total direct costs in contract years 1-7.
(2) The Government is not obligated to pay any additional amount should the
final indirect cost rates exceed these negotiated ceiling rates. In
the event that the final indirect cost rates are less than these
negotiated ceiling rates, the final negotiated ceiling rates shall be
reduced to conform to the lower rates.
Any costs over and above this cost ceiling shall not be reimbursed
under this contract or any other Government contract, grant, or
cooperative agreement.
(3) The Contractor shall complete all work in accordance with the Statement
of Work, terms and conditions of this contract.
b. Subcontract
-----------
Funds in the amount of $171,156 are specifically reserved for a fixed
--------
price type subcontract with Information Management Services, Inc. (IMS) for
-------------------------------------------
the purposes of maintaining a test results database, transmitting the data
to the AVEG Statistical and Clinical Coordinating Center (SCC) or to the
HIVNET Statistical and Data Coordinating Center (SDCC) and providing
regular status reports to the Project Officer . Award of the subcontract
shall not proceed without the prior written approval of the Contracting
Officer upon review of the supporting documentation as required by the
Subcontracts clause of the General Clauses incorporated in this contract.
(After written approval of the subcontract by the Contracting Officer, a
copy of the signed, approved subcontract shall be provided to the
Contracting Officer.)
c. Government Property
-------------------
In recognition of the title provisions of the Contractor-Acquired Government
Property clause of this contract, and of the need to clarify the Government's
intent to retain title per FAR 52.245-5, paragraph (c)(3) of Alternate I, title
of the following items of general purpose equipment shall be retained by the
Government:
Description Cost
----------- ---------
Label Printing Equipment $ 5,800
(Barcoding System)
3
Contract No. N01-AI-85341
Portable Data Collection Equipment $ 5,200
[to include: software support (year 1 only); $ 595
development software; and $ 1,995
programming support (5hrs., set-up)] $ 500
---------
TOTAL $ 14,090
d. The Contractor agrees to submit an annual and a final inventory of
Government property as required by the DHHS "Contractor's Guide for Control
of Government Property." Inventories shall be submitted to the Contract
Property Administrator identified in Article G.4. of this contract, with a
------
copy to the Contracting Officer. Annual inventories shall be submitted
-------------------------------
October 31 each year.
e. The Contractor agrees to abide by the terms of FAR 52.247-63, Preference
for U.S.-Flag Air Carriers. This provision states in part that, in
performing work under this contract, the contractor shall utilize U.S. flag
air carriers unless service by those carriers is not available. If U.S.
flag air carriers are not available the Contractor shall so certify in
writing and include that certification/justification in the request for
advance approval of foreign travel. (Cost/lower fares are not acceptable
reasons for proposing to utilize foreign air carriers.)
f. Invoices - Cost and Personnel Reporting, and Variances from the Negotiated
--------------------------------------------------------------------------
budget
------
(1) The contractor agrees to provide a detailed breakdown on invoices of
the following cost categories:
(a) Direct Labor - List individuals by name, title/position,
hourly/annual rate, level of effort, and amount claimed.
(b) Overhead - Cite rate and amount
(c) Materials & Supplies - Include detailed breakdown when total amount
is over $1,000.
(d) Travel - Identify travelers, dates, destination, purpose of trip,
and amount. Cite COA, if appropriate. List separately, domestic
travel, general scientific meeting travel, and foreign travel.
(e) Subcontracts - Attach subcontractor invoice(s).
(f) Equipment - Cite authorization and amount.
(g) Other Direct Costs
(h) G&A - Cite rate and amount.
(i) Total Cost
(j) Fixed Fee
(k) Total CPFF
Monthly invoices must include the cumulative total expenses to date,
adjusted (as applicable) to show any amounts suspended by the
Government.
(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 Cost Clauses
in the contract.
g. Scientific Meetings
-------------------
Travel to general scientific meetings shall not exceed $3,448 without prior
------
written approval of the Contracting Officer.
h. Upon completion of this contract, the contractor shall transfer the license
for the BSI system and its Results-Data Base, as obtained from its proposed
subcontractor, Information Management Services, Inc. (IMS) to the
government (specifically the NIAID) or to any government approved successor
contractor. This transfer process shall also include the relocation of an
associated computer server, its hardware, and all appropriate data-bases
(including all software source codes) to the government (specifically the
NIAID), or any government approved successor contractor.
4
Contract No. N01-AI-85341
i. The Contractor agrees that samples/products received from/through the
government for utilization under this contract shall be used only for
purposes required by this contract.
j. Because the Contractor will be utilizing and evaluating materials provided
to the Government by third parties including AIDS vaccine product and
reagent developers and AIDS vaccine trial investigators, it is essential to
include provisions that will protect the rights of these third parties as
follows:
The Contractor agrees that manuscripts/abstracts based on data/information
generated under this contract will not be submitted for publication until
written Project Officer clearance has been received. Contract support
shall be acknowledged in all such publications. A "publication" is defined
as an issue of printed material offered for distribution or any
communication or oral presentation of information.
The Project Officer will review all manuscripts/documents in a period of
time not to exceed 30 calendar days from receipt, and will either grant
clearance for publication/disclosure, recommend changes or, as applicable,
refer the document to the Third Party Supplier of the materials for their
review.
The NIAID will use its best efforts to assist and expedite the review
process by the Third Party Suppliers wherever possible.
k. Correspondence Procedures
-------------------------
To promote timely and effective administration, correspondence (except for
invoices/financial reports, technical progress reports/other deliverables)
submitted under this contract shall be subject to the following procedures:
1. Technical correspondence shall be addressed to the Project Officer with
an information copy of the basic correspondence to the Contracting
Officer. (As used herein, technical correspondence excludes
--------
correspondence which proposes deviations from or modifications of
contract requirements, terms or conditions.)
2. Other correspondence shall be addressed to the Contracting Officer, with
an information copy of the basic correspondence to the Project Officer.
3. Subject Line(s). All correspondence shall contain a subject line
commencing with the contract number as illustrated below:
SUBJECT: Contract No. N01-AI-85341
Request for Approval of:
5
Contract No. N01-AI-85341
SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT
- -----------------------------------------------------
ARTICLE C.1. STATEMENT OF WORK
- -------------------------------
Independently and not as an agent of the Government, the Contractor shall
furnish all the necessary services, qualified personnel, material, equipment,
and facilities, not otherwise provided by the Government as needed to perform
the Statement of Work, SECTION J, ATTACHMENT A, dated July 1, 1998, attached
------------
hereto and made a part of this contract.
ARTICLE C.2. REPORTING REQUIREMENTS
- ------------------------------------
a. Technical Reports
-----------------
In addition to those 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:
I. Quarterly Progress Report
-------------------------
By the 15th calendar day following the end of each quarter, the
Contractor shall submit three (3) copies of a quarterly progress report
as described below. Two (2) copies should be submitted to the Project
Officer and one (1) copy to the Contracting Officer. The quarterly
report should be factual and concise and consist of the following:
1) A title page containing:
(a) Contract number and title
(b) Sequence of report; e.g., "Year 1, 2nd Quarterly Report"
(c) Period of performance being reported
(d) Contractor's name and address
(e) Date of submission
2) Reports shall include, but are not limited to the following
information:
(a) A brief introduction covering the objective and scope of the
contract effort.
(b) A description of overall progress plus short descriptions of
the methodology and reagents employed for each immunological or
virological assay employed during the performance period,
specifying changes in critical reagents or protocols.
(c) Separate tables listing:
1] An inventory of specimens received during the performance
period, but on which assays have not yet been performed.
2] The assays performed during the performance period,
indicating number of each performed.
3] The specimens on which assays were performed during the
performance period.
4] An ordered listing and interpretation of results from all
immunological or virological assays performed during the
performance period.
5] A listing of the data electronically transmitted to the
AIDS Vaccine Evaluation
6
Contract No. N01-AI-85341
Group Statistical and Coordinating
or to the HIVNET Statistical and Data Coordinating Center.
(d) A description of any technical or performance problems
encountered and corrective actions planned or taken. An
explanation of any differences between planned and actual
progress should be included.
(e) Selected other information as may be required by the Project
Officer.
3) A quarterly report is not due when an annual report is due.
II. Annual Report
On or before the last day of the Contract year, the Contractor shall
submit three (3) copies of an annual report. Two (2) copies shall be
submitted to the Project Officer and one (1) copy shall be submitted to
the Contracting Officer. The annual report shall summarize progress
for the entire contract year, following the same format as for the
quarterly reports, and shall take the place of the fourth quarterly
report. In addition, it should include abstracts, manuscripts in
progress or submitted, and publications resulting from the performance
of work under this contract. An annual report is not required when the
final report is due.
III. Interim Reports
1) Once a month, a status report listing the clinical specimens
received for analysis (number per protocol, type), the assays in
progress (type and protocol), and the test results transmitted to
the Statistical and Coordinating Centers (type and protocol) since
the last status report shall be submitted to the Project Officer.
The preferred format for this status report is a chart.
2) Upon request by the Project Officer, and within 5 working days of
such a request, the Contractor shall provide an interim report of
immunological assay results or other data for inclusion in AIDS Vaccine
Evaluation Group Meeting materials, HIVNET Group Meeting materials,
AIDS Vaccine Research Committee meeting materials, and the AIDS Vaccine
Data and Safety Monitoring Board, or for other designated meetings
where presentation of the most recent data available from the AIDS
vaccine trials is required. These interim reports are likely to be
required approximately six times a year.
IV. Final Report
The contractor shall submit three (3 copies of the final report
documents, two (2) copies to the Project Officer and one (1) copy to
the Contracting Officer, which will summarize the results of the entire
contract work for the complete performance period. This report will be
in sufficient detail to explain comprehensively the results achieved
and will be submitted no later than the completion date of the
Contract.
The final report shall contain:
1) Title Page as described above in paragraph I. 1) (a).
2) Introduction covering the purpose and scope of the contract effort.
3) Description of the overall progress, plus a separate description of
each protocol and type of assay employed and its modifications and
performance on the contract during the period of performance.
Descriptions will include pertinent immunological and virological
assay data in tables or graphs as appropriate to present significant
results
7
Contract No. N01-AI-85341
achieved, conclusions resulting from analysis, and a
scientific evaluation of the data accrued under the contract.
4) Copies of any abstracts, manuscripts, and publications.
V. Other Deliverables
1) For any virological or immunological assay that may be identified
during the period of the contract, as offering potential for
assessment of vaccine immunogenicity or safety and requested to be
developed or adapted, standardized, quality assured, ad performed, a
detailed protocol for the assay shall be provided to the Project
Officer for approval, prior to implementation.
2) The Contractor, when instructed by the Project Office, shall deliver
to the Government or its designee by the completion date of the
Contract, the following items:
(a) Stored volunteer specimens, material derived from volunteer
specimens (e.g., HIV isolates, T cell clones), or reagents,
including those received by the Contractor from the Project
Officer or designated investigators;
(b) A computer-generated listing of accurate and updated information
on the specimen and reagent inventories, including activities of
the Contractor, computerized data files, original data and any
necessary information related thereto;
(c) Labeled and inventoried paper files; and
(d) Government-owned equipment and property.
VI. If the Contractor becomes unable to deliver the reports or other
deliverables here specified within the period of performance because of
unforeseen difficulties, notwithstanding the exercise of good faith and
diligent efforts in performance of the work, the Contractor shall give
the Contracting Officer immediate written notice of anticipated delays
with reasons therefore at the address given in Article F.1., paragraph
b.
ARTICLE C.3. INVENTION REPORTING REQUIREMENT
- ---------------------------------------------
All reports and documentation required by FAR Clause 52.227-11 including, but
not limited to, the invention disclosure report, the confirmatory license, and
the government support certification, shall be directed to the Office of
Extramural Inventions and Technology Resources Branch, OPERA, NIH, 6701
Rockledge Drive, Room 3190, Bethesda, Maryland 20892-7750 (Telephone:
301-435-1986). In addition, one copy of the annual utilization report, and a
copy of the final invention statement, shall be submitted to the Contracting
Officer at the address listed below. The final invention statement (see FAR
27.303(a)(2)(ii)) shall be submitted within 90 days after contract expiration
to the following address:
Contracting Officer
National Institute of Allergy
and Infectious Diseases
National Institutes of Health
Solar Building, Room 3C07, MSC 7610
Bethesda, Maryland 20892 - 7610
To assist contractors in complying with invention reporting requirements of the
clause, the NIH has developed
8
Contract No. N01-AI-85341
"Interagency Edison," an electronic invention
reporting system. Use of Interagency Edison is encouraged as it streamlines
the reporting process and greatly reduces paperwork. Access to the system is
through a secure interactive Web site to ensure that all information submitted
is protected. Interagency Edison and information relating to the capabilities
of the system can be obtained from the Web (http://www.iedison.gov), or by
----------------------
contacting the Office of Extramural Inventions and Technology Resources Branch,
OPERA, NIH.
SECTION D - PACKAGING, MARKING AND SHIPPING
- -------------------------------------------
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.
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 designated Project Officer is the
authorized representative of the Contracting Officer.
c. Inspection and acceptance will be performed by the Project Officer at
the address listed in the clause "Project Officer" in Section G,
Article G.1.
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 No. 52.246-9, INSPECTION OF RESEARCH AND DEVELOPMENT (SHORT FORM)
(APRIL 1984).
SECTION F - DELIVERIES OR PERFORMANCE
- -------------------------------------
ARTICLE F.1 . DELIVERIES
- -------------------------
Satisfactory performance of the final contract shall be deemed to occur upon
delivery and acceptance by the Contracting Officer, or the duly authorized
representative, of the following items in accordance with the stated delivery
schedule:
a. 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 CONSIGNEES PREMISES (APRIL 1984),
and in accordance with and by the date(s) specified below:
Item Description Quantity Delivery Schedule
---- ----------- -------- -----------------
(a) Quarterly Progress 3 10/15/98, 99, 00, 01, 02, 03, 04
Reports 01/15/99, 00, 01, 02, 03, 04, 05
04/15/99, 00, 01, 02, 03, 04, 05
9
Contract No. N01-AI-85341
(b) Interim Progress 3 Within 5 working days of
Reports P.O. request
(c) Annual Progress 3 07/01/99, 00, 01, 02, 03, 04
Reports
(d) Final Progress 3 06/30/05
Report
b. The above items shall be addressed and delivered to:
Addressee Deliverable Item No. Quantity
--------- -------------------- --------
Project Officer (a) 2
CDB, VPRP, DAIDS (b) 2
NIAID, NIH (c) 2
Solar Bldg, Rm. 2A33 (d) 2
6003 Executive Blvd. MSC 7620
Bethesda, MD 20892-7620
Contract Specialist (a) 1
CMB, DEA, NIAID, NIH (c) 1
Solar Bldg., Rm. 3C07 (d) 1
6003 Executive Blvd. MSC 7610
Bethesda, MD 20892-7610
ARTICLE F.2. 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. Mary Clare Walker
CDB, VPRP, DAIDS, NIAID
Solar Building, Room 2A33
6003 Executive Boulevard MSC 7620
Bethesda, Maryland 20892-7620
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
10
Contract No. N01-AI-85341
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 Contracting Officer hereby delegates the Project Officer as the
Contracting Officer's authorized representative responsible for signing
software license agreements issued as a result 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 individuals are considered to be essential to the work being
performed hereunder:
NAME TITLE
---- -----
Mark Cosentino, PhD. Principal Investigator
Carl Wild, Ph.D. Co-Investigator
C.C. Tai, Ph.D. Co-Investigator
Mark Manak, Ph.D. Co-Investigator
ARTICLE G.3 . INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT
- --------------------------------------------------------------------------
FINANCIAL REPORT
- ----------------
a. Invoice/Financing Request Instructions and Contract Financial Reporting
for NIH Cost-Reimbursement Type Contracts NIH(RC)-4 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.
(1) Invoices/financing requests shall be submitted as follows:
An original and two copies to the following designated billing
office:
Contracting Officer
CMB, DEA, NIAID, NIH
Solar Bldg., Room 3C07
6003 Executive Boulevard MSC 7610
Bethesda, Maryland 20892-7610
(2) Inquiries regarding payment of invoices should be directed to
the designated billing office, (301) 496-3699.
ARTICLE G.4. 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
11
Contract No. N01-AI-85341
publication is available upon request to the Contract Property
Administrator at the following address:
Contracts Property Administrator
Research Contracts Property Administration, NIH
6011 Executive Blvd., Room 641E
ROCKVILLE MD 20852-7670
(301) 496-6466
b. Contractor-Acquired Government Property - Schedule I-A
------------------------------------------------------
Pursuant to the clause, GOVERNMENT PROPERTY, incorporated in this
contract, the Contractor is hereby authorized to acquire the property
listed for use in direct performance of the contract:
Schedule I-A
------------
Description Cost
Label Printing Equipment $ 5,800
(Barcoding System)
Portable Data Collection Equipment $ 5,200
[to include: software support (year 1 only); $ 595
development software; and $ 1,995
programming support (5hrs., set-up)] $ 500
--------
TOTAL $14,090
ARTICLE G.5. 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.1. REIMBURSEMENT OF COSTS FOR INDEPENDENT RESEARCH AND DEVELOPMENT
- -----------------------------------------------------------------------------
PROJECTS
- --------
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
12
Contract No. N01-AI-85341
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. HUMAN SUBJECTS
- ----------------------------
It is hereby understood and agreed that research involving human subjects shall
not be conducted under this contract, and that no material developed, modified,
or delivered by or to the Government under this contract, or any subsequent
modification of such material, will be used by the Contractor or made available
by the Contractor for use by anyone other than the Government, for experimental
or therapeutic use involving humans without the prior written approval of the
Contracting Officer.
ARTICLE H.3. HUMAN MATERIALS
- ----------------------------
It is understood that the acquisition and supply of all human specimen material
(including fetal material) used under this contract will be obtained by the
Contractor in full compliance with applicable State and Local laws and the
provisions of the Uniform Anatomical Gift Act in the United States and that no
undue inducements, monetary or otherwise, will be offered to any person to
influence their donation of human material.
ARTICLE H.4. CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH
- ---------------------------------------------------------------
Section 513 of the Fiscal Year 1998 Appropriations Act (P.L. 105-78) prohibits
NIH from using appropriated funds to support human embryo research. Contract
funds may not be used for (1) the creation of a human embryo or embryos for
research purposes; or (2) research in which a human embryo or embryos are
destroyed, discarded, or knowingly subjected to risk of injury or death greater
than that allowed for research on fetuses in utero under 45 CFR 46.208(a)(2)
and Section 498(b) of the Public Health Service Act (42 U.S.C . 289g(b)). The
term "human embryo or embryos" includes any organism, not protected as a human
subject under 45 CFR 46 as of the date of the Act, that are derived by
fertilization, parthenogenesis, cloning, or any other means from one or more
human gametes or human diploid cells.
Additionally, in accordance with a March 4, 1997 Presidential Memorandum,
Federal funds may not be used for cloning of human beings.
ARTICLE H.5. SALARY RATE LIMITATION LEGISLATION PROVISIONS
- -----------------------------------------------------------
a. Pursuant to Public Law(s) cited in paragraph b., below, no NIH Fiscal
Year funds for the applicable fiscal year(s) and periods cited in
paragraph b., below may be used to pay the direct salary of an
individual through this contract at a rate in excess of applicable
amount shown for the fiscal year and period covered. Direct salary is
exclusive of overhead, fringe benefits and general and administrative
expenses. The per year salary rate limit also applies to individuals
proposed under subcontracts. If this is a multi-year contract, it may
be subject to unilateral modifications by the Government if an
individual's salary rate exceeds any salary rate ceiling established in
future DHHS appropriation acts.
Dollar Amount of
b. Public Law No. Fiscal Year Period Covered Salary Limitation
-------------- ----------- -------------- -----------------
105-78 1998 10/01/97 - 09/30/98 $125,000
13
Contract No. N01-AI-85341
ARTICLE H.6. EPA ENERGY STAR REQUIREMENTS
- ------------------------------------------
In compliance with Executive Order 12845 (requiring Agencies to purchase energy
efficient computer equipment) all microcomputers, including personal computers,
monitors, and printers that are deliverables under the procurement or are
purchased by the contractor using Government funds in performance of a contract
shall be equipped with or meet the energy efficient low-power standby feature
as defined by the EPA Energy Star program unless the equipment always meets EPA
Energy Star efficiency levels. The microcomputer, as configured with all
components, must be Energy Star compliant.
This low-power feature must already be activated when the computer equipment is
delivered to the agency and be of equivalent functionality of similar power
managed models. If the equipment will be used on a local area network, the
vendor must provide equipment that is fully compatible with the network
environment. In addition, the equipment will run commercial off-the-shelf
software both before and after recovery from its energy conservation mode.
ARTICLE H.7. PUBLICATION AND PUBLICITY
- ---------------------------------------
The contractor shall acknowledge the support of the National Institutes of
Health whenever publicizing the work under this contract in any media by
including an acknowledgment substantially as follows:
"This project has been funded in whole or in part with Federal funds
from the National Institute of Allergy and Infectious Diseases,
National Institutes of Health, under Contract No. NO1-AI-85341."
ARTICLE H.8. PRESS RELEASES
- ----------------------------
Pursuant to Section 508 of Public Law 105-78, 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 that: (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.
ARTICLE H.9. NEEDLE EXCHANGE
- -----------------------------
Pursuant to Section 505 of Public Law 105-78, 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. Section 505, however, is subject to
the condition stated in Section 506. Specifically, Section 506 states that
after March 31, 1998, a program for exchanging needles and syringes for used
hypodermic needles and syringes may be carried out in a community if: (1) the
Secretary of Health and Human Services determines that exchange projects are
effective in preventing the spread of HIV and do not encourage the use of
illegal drugs; and (2) the project is operated in accordance with criteria
established by the Secretary for preventing the spread of HIV and for ensuring
that the project does not encourage the use of illegal drugs.
ARTICLE H.10. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE
- ----------------------------------------------------------------
14
Contract No. N01-AI-85341
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
HHS Inspector General's Office in writing or on the Inspector General's
Hotline. The toll free number is 1-800-HHS-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)
15
Contract No. N01-AI-85341
ARTICLE H.11. YEAR 2000 COMPLIANCE
- ----------------------------------
In accordance with FAR 39.106, Information Technology acquired under this
contract must be Year 2000 compliant as set forth in the following clause(s):
1. Service Involving the Use of Information Technology
---------------------------------------------------
YEAR 2000 COMPLIANCE--SERVICE INVOLVING THE USE OF INFORMATION
TECHNOLOGY
The Contractor agrees that each item of hardware, software, and
firmware used under this contract shall be able to accurately process
date data (including, but not limited to, calculating, comparing and
sequencing) from, into and between the twentieth and twenty-first
centuries and the Year 1999 and the Year 2000 and leap year
calculations.
(End of Clause)
2. Noncommercial Supply Items Warranty
-----------------------------------
YEAR 2000 WARRANTY--NONCOMMERCIAL SUPPLY ITEMS
The contractor warrants that each noncommercial item of hardware,
software, and firmware delivered or developed under this contract and
listed below shall be able to accurately process date data (including,
but not limited to, calculating, comparing and sequencing) from, into
and between the twentieth and twenty-first centuries and the Year 1999
and the Year 2000 and leap year calculations, when used in accordance
with the item documentation provided by the contractor, provided that
all listed or unlisted items (e.g., hardware, software and firmware)
used in combination with such listed item properly exchange date data
with it. If the contract requires that specific listed items must
perform as a system in accordance with the foregoing warranty, then
that warranty shall apply to those listed items as a system. The
duration of this warranty and the remedies available to the Government
for breach of this warranty shall be as defined in, and subject to, the
terms and limitations of any general warranty provisions of this
contract provided that notwithstanding any provision to the contrary in
such warranty provision(s), or in the absence of any such warranty
provision(s), the remedies available to the Government under this
warranty shall include repair or replacement of any listed item whose
noncompliance is discovered and made known to the contractor in writing
within ninety (90) days after acceptance. Nothing in this warranty
shall be construed to limit any rights or remedies the Government may
otherwise have under this contract with respect to defects other than
Year 2000 performance.
YEAR 2000 COMPLIANT ITEMS
-------------------------------------------
-------------------------------------------
-------------------------------------------
(end of clause)
3. Commercial Supply Products Warranty
-----------------------------------
YEAR 2000 WARRANTY--COMMERCIAL SUPPLY ITEMS
The contractor warrants that each hardware, software and firmware
product delivered under this contract and listed below shall be able to
accurately process date data (including, but not limited to,
calculating, comparing, and sequencing) from, into, and between the
twentieth and twenty-first centuries and the Year 1999 and the Year
2000 and leap year calculations, when used in accordance with the
product
16
Contract No. N01-AI-85341
documentation provided by the contractor, provided that all listed or
unlisted products (e.g., hardware, software, firmware) used in
combination with such listed product properly exchange date data with
it. If the contract requires that specific listed products must
perform as a system in accordance with the foregoing warranty, then
that warranty shall apply to those listed products as a system. The
duration of this warranty and the remedies available to the Government
for breach of this warranty shall be as defined in, and subject to, the
terms and limitations of the contractor's standard commercial warranty
or warranties contained in this contract, provided that
notwithstanding any provision to the contrary in such commercial
warranty or warranties, the remedies available to the Government under
this warranty shall include repair or replacement of any listed product
whose non-compliance is discovered and made known to the contractor in
writing within ninety (90) days after acceptance. Nothing in this
warranty shall be construed to limit any rights or remedies the
Government may otherwise have under this contract with respect to
defects other than Year 2000 performance.
YEAR 2000 COMPLIANT ITEMS
-------------------------------------------
-------------------------------------------
-------------------------------------------
(end of clause)
17
Contract No. N01-AI-85341
PART II - CONTRACT CLAUSES
--------------------------
SECTION I - CONTRACT CLAUSES
- ----------------------------
ARTICLE I.1. GENERAL CLAUSES FOR A COST-REIMBURSEMENT RESEARCH AND DEVELOPMENT
- -------------------------------------------------------------------------------
CONTRACT - FAR 52.252-2, CLAUSES INCORPORATED BY REFERENCE (FEBRUARY 1998)
- --------
This contract incorporates the following clauses by reference, with the same
force and effect as if they were given in full text. Upon request, the
Contracting Officer will make their full text available. Also, the full text
of a clause may be accessed electronically at this address:
http://www.arnet.gov/far/.
a. FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES:
FAR
CLAUSE NO. TITLE AND DATE
---------- --------------
52.202-1 Definitions (OCTOBER 1995)
52.203-3 Gratuities (Over $100,000) (APRIL 1984)
52.203-5 Covenant Against Contingent Fees (Over $100,000)
(APRIL 1984)
52.203-6 Restrictions on Subcontractor Sales to the Government
(Over $100,000) (JULY 1995)
52.203-7 Anti-Kickback Procedures (Over $100,000) (JULY 1995)
52.203-8 Cancellation, Rescission, and Recovery of Funds for
Illegal or Improper Activity (Over $100,000)
(JANUARY 1997)
52.203-10 Price or Fee Adjustment for Illegal or Improper
Activity (Over $100,000) (JANUARY 1997)
52.203-12 Limitation on Payments to Influence Certain Federal
Transactions (Over $100,000) (JUNE 1997)
52.204-4 Printing/Copying Double-Sided on Recycled Paper (Over
$100,000) (JUNE 1996)
52.209-6 Protecting the Government's Interests when
Subcontracting with Contractors Debarred, Suspended, or
Proposed for Debarment (Over $25,000) (JULY 1995)
52.215-2 Audit and Records - Negotiation (Over $100,000) (AUGUST
1996)
52.215-8 Order of Precedence-Uniform Contract Format (OCTOBER
1997)
52.215-10 Price Reduction for Defective Cost or Pricing Data
(Over $500,000) (OCTOBER 1997)
18
Contract No. N01-AI-85341
52.215-12 Subcontractor Cost or Pricing Data (Over $500,000)
(OCTOBER 1997)
52.215-14 Integrity of Unit Prices (Over $100,000) (OCTOBER 1997)
52.215-15 Termination of Defined Benefit Pension Plans (OCTOBER
1997)
52.215-18 Reversion or Adjustment of Plans for Post-Retirement
Benefits (PRB) other than Pensions (OCTOBER 1997)
52.215-19 Notification of Ownership Changes (OCTOBER 1997)
52.215-21 Requirements for Cost or Pricing Data or Information
Other Than Cost or Pricing Data--Modifications (OCTOBER
1997)
52.216-7 Allowable Cost and Payment (APRIL 1998)
52.216-8 Fixed Fee (MARCH 1997)
52.219-8 Utilization of Small, Small Disadvantaged, and
Women-Owned Small Business Concerns (Over $100,000)
(JUNE 1997)
52.219-9 Small, Small Disadvantaged, and Women-Owned Small
Business Subcontracting Plan (Over $500,000) (AUGUST
1996)
52.219-16 Liquidated Damages - Subcontracting Plan (Over
$500,000) (OCTOBER 1995)
52.222-2 Payment for Overtime Premium (Over $100,000) (JULY
1990) (NOTE: The dollar amount in paragraph (a) of this
clause is $0 unless otherwise specified in the
contract.)
52.222-3 Convict Labor (AUGUST 1996)
52.222-26 Equal Opportunity (APRIL 1984)
52.222-28 Equal Opportunity Preaward Clearance of Subcontracts
(Over $1,000,000) (APRIL 1984)
52.222-35 Affirmative Action for Disabled Veterans and Veterans
of the Vietnam Era (APRIL 1998)
52.222-36 Affirmative Action for Handicapped Workers (APRIL 1984)
52.222-37 Employment Reports on Disabled Veterans and Veterans of
the Vietnam Era (APRIL 1998)
52.223-2 Clean Air and Water (Over $100,000) (APRIL 1984)
52.223-6 Drug-Free Workplace (JANUARY 1997)
52.223-14 Toxic Chemical Release Reporting (OCTOBER 1996)
52.225-3 Buy American Act--Supplies (JANUARY 1994)
52.225-11 Restrictions on Certain Foreign Purchases (OCTOBER
1996)
19
Contract No. N01-AI-85341
52.227-1 Authorization and Consent (Over $50,000) (JULY
1995)--Alternate I (APRIL 1984)
52.227-2 Notice and Assistance Regarding Patent and Copyright
Infringement (Over $100,000) (AUGUST 1996)
52.227-11 Patent Rights - Retention by the Contractor (Short
Form) (JUNE 1997) NOTE: In accordance with FAR
27.303(a)(2),paragraph (f) is modified to include the
requirements in FAR 27.303(a)(2) (i) through (iv). The
frequency of reporting in (i) is annual.
52.227-14 Rights in Data - General (JUNE 1987)
52.232-9 Limitation on Withholding of Payments (APRIL 1984)
52.232-17 Interest (Over $100,000) (JUNE 1996)
52.232-20 Limitation of Cost (APRIL 1984)
52.232-23 Assignment of Claims (JANUARY 1986)
52.232-25 Prompt Payment (JUNE 1997)
52.232-33 Mandatory Information for Electronic Funds Transfer
Payment (AUGUST 1996)
52.233-1 Disputes (OCTOBER 1995)
52.233-3 Protest After Award (AUGUST 1996) With Alternate I
(JUNE 1985)
52.242-1 Notice of Intent to Disallow Costs (APRIL 1984)
52.242-3 Penalties for Unallowable Costs (Over $500,000)
(OCTOBER 1995)
52.242-4 Certification of Final Indirect Costs (JANUARY 1997)
52.242-13 Bankruptcy (Over $100,000) (JULY 1995)
52.243-2 Changes - Cost Reimbursement (AUGUST 1987) Alternate V
(APRIL 1984)
52.244-2 Subcontracts (Cost-Reimbursement and Letter Contracts)
(FEBRUARY 1997) *If written consent to subcontract is
required, the identified subcontracts are listed in
ARTICLE B, Advance Understandings.
52.244-5 Competition in Subcontracting (Over $100,000) (DECEMBER
1996)
52.245-5 Government Property (Cost-Reimbursement, Time and
Material, or Labor-Hour Contract) (JANUARY 1986)
52.246-23 Limitation of Liability (Over $100,000) (FEBRUARY 1997)
52.249-6 Termination (Cost-Reimbursement) (SEPTEMBER 1996)
52.249-14 Excusable Delays (APRIL 1984)
20
Contract No. N01-AI-85341
52.253-1 Computer Generated Forms (JANUARY 1991)
b. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR)
(48 CFR CHAPTER 3) CLAUSES:
HHSAR
CLAUSE NO. TITLE AND DATE
---------- --------------
352.202-1 Definitions (APRIL 1984) Alternate I (APRIL 1984)
352.228-7 Insurance - Liability to Third Persons (DECEMBER 1991)
352.232-9 Withholding of Contract Payments (APRIL 1984)
352.233-70 Litigation and Claims (APRIL 1984)
352.242-71 Final Decisions on Audit Findings (APRIL 1984)
352.270-5 Key Personnel (APRIL 1984)
352.270-6 Publication and Publicity (JULY 1991)
352.270-7 Paperwork Reduction Act (APRIL 1984)
[End of GENERAL CLAUSES FOR A COST-REIMBURSEMENT RESEARCH AND DEVELOPMENT
CONTRACT - Rev. 4/98]
21
Contract No. N01-AI-85341
ARTICLE I.2 AUTHORIZED SUBSTITUTION OF CLAUSES
- -----------------------------------------------
ARTICLE I.1. of this SECTION is hereby modified as follows:
FAR Clause 52.225-3, BUY AMERICAN ACT - SUPPLIES (JANUARY 1994) is deleted in
its entirety and FAR Clause 52.225-9, TRADE AGREEMENTS ACT (DEVIATION) is
substituted therefor. (This deviation was prescribed pursuant to GSBCA
Decision No. 10532-P, dated May 18 1990, and CAAC Letter 90-09. The full text
of the clause appears in Article I.4.)
FAR Clause 52.232-20, LIMITATION OF COST, is deleted in its entirety and FAR
Clause 52.232-22, LIMITATION OF FUNDS (APRIL 1984) is substituted therefor.
FAR Clause 52.232-33, MANDATORY INFORMATION FOR ELECTRONIC FUNDS TRANSFER
PAYMENT (AUGUST 1996) is deleted, and FAR Clause 52.232-34, OPTIONAL
INFORMATION FOR ELECTRONIC FUNDS TRANSFER PAYMENT (AUGUST 1996) is substituted
therefor.
ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES
- -----------------------------------------
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.
a. FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES
(1) FAR 52.211-13, Time Extensions (APRIL 1984).
(2) FAR 52.227-14, Rights in Data - General (JUNE 1987).
(3) Alternate III (JUNE 1987), FAR 52.227-14, Rights in
Data--General (JUNE 1987).
Additions to, or limitations on, the restricted rights set
forth in the Restricted Rights Notice of subparagraph (g)(3) of
the clause are expressly stated as follows:
(4) FAR 52.243-2, Changes--Cost Reimbursement (AUGUST 1987),
Alternate V (APRIL 1984).
(5) FAR 52.251-1, Government Supply Sources (APRIL 1984).
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) HHSAR 352.224-70, Confidentiality of Information (APRIL 1984).
(3) HHSAR 352.270-1, Accessibility of Meetings, Conferences and
Seminars to Persons with Disabilities (APRIL 1984).
c. NATIONAL INSTITUTES OF HEALTH (NIH) RESEARCH CONTRACTING (RC) CLAUSES:
The following clauses are attached and made a part of this contract:
22
Contract No. N01-AI-85341
(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
- -------------------------------------------------------------------
a. FAR Clause 52.244-6 SUBCONTRACTS FOR COMMERCIAL ITEMS AND
-------------------------------------
COMMERCIAL COMPONENTS (APRIL 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 non developmental 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 Disabled Veterans and
Veterans of the Vietnam Era (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.
23
Contract No. N01-AI-85341
PART III
--------
SECTION J - LIST OF ATTACHMENTS
- -------------------------------
The following documents are attached and incorporated in this contract:
1. Statement of Work, 7/1/98, ATTACHMENT A, 6 pages.
2. Invoice/Financing Request and Contract Financial Reporting Instructions
for NIH Cost-Reimbursement Type Contracts, NIH(RC)-4 (5/97), ATTACHMENT
B, 5 pages.
3. Safety and Health (Deviation), PHSAR Clause 352.223-70, (8/97),
ATTACHMENT C, 1 page.
4. Procurement of Certain Equipment, NIH(RC)-7, 4/1/84, ATTACHMENT D, 1
page.
24
Contract No. N01-AI-85341
PART IV
-------
SECTION K - REPRESENTATIONS AND CERTIFICATIONS
- ----------------------------------------------
The following documents are incorporated by reference in this contract:
1. Representations and Certifications, dated October 30, 1997.
END of the SCHEDULE
-------------------
(CONTRACT)
25
Contract No. N01-AI-85341
STATEMENT OF WORK
-----------------
WORK STATEMENT
- --------------
Independently and not as an agent of the Government, the Contractor shall exert
its best efforts to furnish all necessary services, qualified personnel,
materials, equipment, and facilities, not otherwise provided by the Government
under the terms of this contract, as needed to provide Laboratory Support for
AIDS Vaccine and Other Prevention Intervention Phase I, II, and III clinical
trials as set forth below.
In general, the Contractor shall perform a variety of standardized assays to
detect and diagnose HIV-1 infection, as well as to assess humoral immune
responses, on specimens from volunteers enrolled in NIAID-sponsored AIDS
vaccine and other prevention intervention clinical trials annually. The
Contractor shall provide primary, central, standardized assessment of HIV-1
infection for Phase I and II AVEG Trials and expanded capacity for detection of
HIV-1 infection for Phase I, II, and III HIVNET Trials. Approximately 4000
volunteers will be assessed each year for infection with HIV-1. Laboratory
support for evaluation of candidate AIDS vaccine-induced humoral responses for
the AVEG will concentrate on Phase II trials and for the HIVNET, on Phase I to
III trials, as needed for timely completion of the immunogenicity evaluations
of the different trials Approximately 1000 volunteers will be evaluated each
year for vaccine-induced humoral immune responses. Comparative assays with
specimens from HIV-1-infected individuals or volunteers in non-NIAID-sponsored
trials of candidate AIDS vaccines or other prevention interventions, as
designated by the Project Officer, shall also be performed by the Contractor.
The Contractor shall report the results and analyses of these assays to the
Project Officer in Quarterly, Interim, Annual, and Final Reports. The assay
data shall also be transmitted to the AIDS Vaccine Evaluation Group Statistical
and Coordinating Center (AVEG SCC) or the HIVNET Statistical and Data
Coordinating Center (HIVNET SDCC), as appropriate, for further analysis.
Specifically, the Contractor shall:
I. PERFORM ASSAYS TO DETECT HIV-1 INFECTION.
A. Perform assays for the diagnostic detection of HIV-1 infection
in volunteers receiving candidate AIDS vaccines and volunteers
participating in non-vaccine prevention intervention clinical
trials on fluid, cell, or tissue specimens from the volunteers
which shall include but are not limited to: fresh or dried
blood, serum, plasma, peripheral blood mononuclear cells
(PBMCs), urine, saliva and other mucosal fluids or secretions,
and biopsy or cytobrush specimens. (These assays will be
performed routinely during trials of candidate vaccines as well
as non-vaccine prevention modalities, such as microbicides or
behavioral interventions, to screen volunteers for infection
with HIV-1. In addition, assays will be performed for trials
of candidate AIDS vaccines which express multiple HIV gene
products; e.g., Envelope and Gag proteins, to distinguish
immunization-induced immune responses from those induced by
infection. Once volunteers have completed all the scheduled
visits in a vaccine trial, they are offered long term follow
up. During this follow up of around five years, periodic
screening, including at the volunteer's request, for HIV-1
infection and to determine if they are continuing to produce
immunization-induced anti-HIV antibodies which could make them
appear positive on diagnostic tests for HIV-1 infection based
on HIV-specific antibody detection, will be done.)
B. Employ assays for the detection of HIV-1 infection utilizing a
variety of methods which among them detect anti-HIV antibodies,
products of viral replication (e.g., HIV p24), as well as viral
nucleic acid which shall include, but are not limited to:
1. HIV-1 Enzyme Linked Immunosorben Assays(ELISA)
2. HIV-1 Western Blots (WB)
3. HIV-1 Dot Blots (DB)
Statement of Work ATTACHMENT A
(7/1/98) Page 1
Contract No. N01-AI-85341
4. HIV-1 p24 antigen capture tests (standard and
immune-complex dissociation methods)
5. HIV-1 DNA polymerase chain reaction (PCR) amplification
6. HIV-1 RNA PCR amplification
7. Branched (b) DNA assays
C. Utilize Food and Drug Administration (FDA)-approved HIV-1
ELISAs, DBs, and WBs for diagnosis of HIV infection and AIDS
Clinical Trials Group (ACTG) consensus protocols for the HIV-1
p24 antigen capture tests. Employ strategies for PCR
amplification and bDNA assays that allow for evaluation of
specimens with low copy numbers, evaluation of different types
of specimens, and genomic variation of HIV.
D. Secure and maintain ACTG accreditation for HIV virology and
molecular biology assays and participate in the ACTG Quality
Assurance Program.
II. PERFORM EVALUATIONS OF HUMORAL IMMUNE RESPONSES INDUCED BY IMMUNIZATION
WITH CANDIDATE AIDS VACCINES.
A. Perform evaluations of HIV-specific humoral immune responses on
specimens from volunteers in AVEG and HIVNET Phase I to III
clinical trials and in post-trial long term follow up,
HIV-infected individuals, or volunteers in non- NIAID AIDS
Vaccine trials.
B. Evaluate, at the request of the Project Officer, type-specific
and cross-reactive HIV neutralizing antibody responses of
volunteers. The virus neutralization assay(s) to be employed
shall be provided or approved in advance by the Project
Officer.
1.. Perform HIV-1 neutralization assays with the vaccine
strain of HIV-1 and other strains of HIV-1, including
primary field isolates of HIV-1, characterized as to
the genetic subtype or clade of HIV-1 to which they
belong.
2. Obtain, separate, screen, aliquot, and store
peripheral blood mononuclear cells (PBMC) or lymphocyte
ormonocyte fractions of PBMCs from HIV-1 uninfected
human volunteers for use in preparing and maintaining
stocks of HIV-1.
a. Obtain directly or through an accredited Blood
Bank or Center, anticoagulated blood, buffy
coats, leukopheresis packs, or cord blood
specimens from healthy, non-HIV-infected
volunteers.
b. Separate the PBMCs, or lymphocyte or monocyte
fractions of the blood specimens, from the
other blood components by density gradient
centrifugation, countercurrent elutriation, or
other established standard method.
c. Aliquot, freeze down, and store the separated
donor cells in liquid nitrogen or in the vapor
phase. Label vials of donor cells individually
with an identifier code, date of collection,
type of cell, number of cells/ml. Donor names
shall not be used as the identifier. (Other
information, such as the specimen tube number,
may be used in some instances. All labels will
be expected to conform to the convention of the
AVEG or HIVNET Manual of Operations. The
Manuals will be provided after an award is
made.)
d. Screen donor cells for the presence of
microbiological agents, such as mycoplasma,
which could affect the propagation of HIV-1.
Discard donor cell lots which are contaminated
with such an adventitious agent.
e. Assess the ability of donor PBMC or monocyte/
macrophages to support virus replication.
Employ a small panel of primary HIV isolates
which are well characterized as to their growth
kinetics in PBMC
Statement of Work ATTACHMENT A
(7/1/98) Page 2
Contract No. N01-AI-85341
cultures for these evaluations. The HIV
isolate panel shall be approved or provided by
the Project Officer.
3. Prepare and maintain HIV-1 stocks for antibody
neutralization assays.
a. Initiate expansion cultures with primary or
seed culture supernatant to yield an adequate
volume of high titered culture fluid and a
final HIV p24 antigen concentration suitable
for testing for virus neutralization.. A
volume of 100 ml of cell-free culture
supernatant with a TCID50 value >1000/ml is
optimal. (However, it is anticipated that many
isolates may not reach these titers under
standard culture conditions. Decisions to
either re-initiate or terminate expansion
cultures due to inadequate growth
characteristics shall be made by the Contractor
in consultation with the Project Officer.)
b. Monitor virus growth by HIV-1 p24 antigen
capture analysis or other methods approved by
the Project Officer.
c. Test virus cultures for the presence of
adventitious agents, including bacteria, fungi,
yeast, and, before they are further expanded or
used in any assays.
d. Clarify culture supernatants, aliquot (1-2 ml),
and freeze for subsequent characterization of
virus.
e. Prepare and freeze cell pellets from all virus
cultures in a manner suitable for subsequent
HIV PCR or genetic sequence analysis to confirm
strain identity.
f. Label all vials of HIV culture supernatants and
cell pellets individually with the HIV isolate
name or identifier, date of harvest, and other
appropriate information, according to the
labeling conventions of the AVEG or HIVNET
Manual of Operations.
g. Store the vials of HIV culture supernatants and
pellets in a liquid nitrogen/vapor phase
freezer.
h. Maintain electronic inventory of frozen HIV-1
stocks with paper back-up files.
i. Thaw vial of expanded virus and determine
endpoint TCID50 titer of the HIV-1 isolates in
cell line(including genetically engineered cell
lines) or PBMC cultures, utilizing protocols
provided by or approved by the Project Officer.
C. Perform antibody binding assays to detect HIV- specific
antibodies. The HIV-specific antibody binding assays to be
employed shall be approved or provided in advance by the
Project Officer.
1. Employ assays to detect HIV-specific binding antibodies
which shall include Enzyme Linked Immunosorbent Assays
(ELISA) and HIV-1 Western Blots (WB) and may include
other types of assays; e.g.,
2. Utilize HIV-specific assays that shall be able to
detect antibodies which bind to particular viral
proteins or peptide epitopes of HIV-1 representative of
the components of HIV included in the specific
candidate vaccine(s) undergoing testing in clinical
trials. Specifically, the viral antigens detectable by
these assays shall include, but are not limited to,
HIV-1 envelope glycoproteins (gp120 and gp160) and
HIV-1 gag proteins (p24). Employ assays that are
sufficiently sensitive to detect HIV-specific
antibodies in sera or more dilute fluid specimens of
volunteers such as saliva. Include positive and
negative antibody controls in all assays.
3. Determine, preferably using an ELISA format, the IgG
subclasses of the vaccine-induced HIV- specific binding
antibodies.
Statement of Work ATTACHMENT A
(7/1/98) Page 3
Contract No. N01-AI-85341
III. ADAPT, STANDARDIZE, QUALITY ASSURE, AND PERFORM ANY VIROLOGICAL OR
IMMUNOLOGICAL ASSAYS IDENTIFIED DURING THE PERIOD OF THE CONTRACT AS
OFFERING POTENTIAL FOR DETECTION OF HIV INFECTION OR ASSESSMENT OF
VACCINE SAFETY OR IMMUNOGENICITY.
A. Adapt, standardize, quality assure, and perform any virological
or immunological assays, at the request of the Project Officer,
that may be identified during the period of the Contract as
offering potential for improved or augmented detection of
HIV-1 infection or of candidate AIDS vaccine-induced humoral
immune responses.
B. Detailed laboratory procedures for any newly adapted assays
shall be provided to the Project Officer for approval before
implementation.
IV. RECEIVE, PROCESS, CATALOG, TRACK, STORE, AND MAINTAIN AN INVENTORY OF
VOLUNTEER SPECIMENS ARRIVING FOR EVALUATION.
A. Advise clinical trial investigators of the most suitable manner
for shipment of collected fluid, cell, or tissue volunteer
specimens for evaluation, which shall include, but are not
limited to: whole anticoagulated blood, peripheral blood
mononuclear cells, plasma, serum, mucosal specimens or biopsy
material. Arrange for the transfer of these specimens from
participating trial sites to the Contractor. Pick up or arrange
for pick up, when necessary, of incoming specimen shipments
from a specified airport or other site in a timely manner and
assure maintenance of activity and/or viability of the
specimens by providing the appropriate temperature in transit
from the airport or other site to the Contractor's laboratory.
Coordinate and monitor all shipments so that activity and
viability of specimens shall not be adversely affected. The
handling and transportation of all volunteer specimens under
this contract shall be in accordance with all applicable local,
state, Federal and international regulations including health
and safety standards.
B. Receive, process and aliquot, if needed, and catalog fluid,
cell, or tissue volunteer specimens arriving for evaluation.
Freeze down and store the (processed) original volunteer
specimen for subsequent analyses. Label all vials of stored
volunteer specimens individually with the AVEG or HIVNET
volunteer identifier and other appropriate information,
according to the labeling conventions of the AVEG or HIVNET
Manual of Operations.
C. Store cataloged, aliquoted specimens under appropriate
conditions to retain maximum virological or immunological
activity.
D. Maintain a specimen tracking and inventory system such that
specimens can easily be accessed for analysis and can be
located from receipt through reporting of assay results into
the central database. Keep documentation on file for all
incoming specimens, including but not limited to: volunteer
identification number, visit number, and visit (collection)
date. Employ a computer inventory system with back up paper
files.
E. Ship remaining volunteer specimens and specimen- derived
materials to the NIAID Clinical Specimen Repository for deposit
after analyses for a specific trial have been completed, at the
direction of or with the approval of the Project Officer.
V. MAINTAIN TEST RESULT DATABASE AND REGULARLY TRANSMIT DATA TO THE AVEG
STATISTICAL AND COORDINATING CENTER (SCC) OR TO THE HIVNET STATISTICAL
AND DATA COORDINATING CENTER (SDCC) AND PROVIDE REGULAR STATUS REPORTS
TO THE PROJECT OFFICER.
A. Compile and maintain a computerized database of all virological
and immunological evaluation test results.
B. Provide for the security, safety, and accuracy of data on the
specimen inventory and the test result database. Ensure
protection against the loss of data by the backup and
duplication of data base files and programs for data
Statement of Work ATTACHMENT A
(7/1/98) Page 4
Contract No. N01-AI-85341
storage, utilizing both electronic and paper files. The test
result database in its entirety shall be capable of being
transferred to the Government without interruption.
C All information as required in sections IV.E. and V.A.- B.
regarding the specimen inventory, the tracking of specimens
through the specimen analysis algorithm, and test result
database shall be retrievable from a central database.
D Transfer data of results for AVEG specimens electronically to
the AVEG SCC at regular intervals in accordance with the
procedures detailed in the AVEG Manual of Operations. (The SCC
will provide specific data entry screens for each type of assay
result to the Contractor for this purpose. The Manual will be
provided after contract award.)
E. Transfer data of results for HIVNET specimens electronically
or by faxscan to the HIVNET SDCC at regular intervals in
accordance with the procedures detailed in the HIVNET Manual
of Operations. (The SDCC will provide specific case report
forms for each type of assay result to the Contractor for this
purpose. The Manual will be provided after contract award.)
F. Furnish to the Project Officer once a month, a status report
listing the clinical specimens received for analysis (number
per protocol, type), the assays in progress (type and
protocol), and the test results transmitted to the AVEG SCC
and the HIVNET SDCC (type and protocol) since the last status
report.
VI. MEET WITH PROJECT OFFICER AND PARTICIPATE IN AVEG-RELATED AND
HIVNET-RELATED CONFERENCE CALLS AND GROUP MEETINGS.
A. Attend meetings with the Project Officer and other staff of the
Vaccine and Prevention Research Program and DAIDS to discuss
the progress of work performed under the Contract.
B. Collaborate, at the request of the Project Officer, in the
development and implementation of Vaccine and other Prevention
Intervention Clinical Trial Protocols by participating as
members of Protocol Teams (Principal Investigator and/or
Co-Investigators).
C. Participate, at the request of the Project Officer, in
AVEG-related and HIVNET-related Group Meetings. These shall
include, but are not limited to, Meetings of the whole AVEG or
HIVNET, AVEG Executive Group Meetings, other committee
meetings such as AVEG Immunology Committee Meetings, Clinical
Protocol Team Meetings, and the Conference on Advances in AIDS
Vaccine Development/National Cooperative Vaccine Development
(NCVDG) Meeting.
D. Ensure development, standardization, quality assurance, and
implementation of consensus virological and immunological
assay protocols and comparability of virological and
immunological assay results among all AVEG and HIVNET
Laboratories by development and exchange of consensus or
standard assay protocols, cross-training of technical staff,
and participation in quality assurance testing, utilizing
blinded, split volunteer specimens. Obtain training for
Contractor professional and/or technical staff at other
laboratories within the AVEG or HIVNET or elsewhere, at the
direction of or with the prior approval of the Project
Officer, or provide training to professional and/or technical
staff of other AVEG or HIVNET Laboratories, at the request of
the Project Officer, or participate in group Workshops or
Working Groups.
VII. PROVIDE FACILITIES AND RESOURCES.
A. Provide facilities and equipment to receive, store, and
manipulate biohazardous materials (Biosafety Level 2
Containment) and maintain their viability. Provide aseptic
and/or sterile conditions as appropriate.
Statement of Work ATTACHMENT A
(7/1/98) Page 5
Contract No. N01-AI-85341
B. Provide, maintain, and operate equipment or facilities for
controlled storage of volunteer specimens and reagents at
ambient temperature (18-22 degrees Celsius (C)), at 2 to 8
degrees C, at -10 to -20 degrees C, at -70 to -90 degrees C,
in vapor phase/liquid nitrogen conditions and all other items
necessary for appropriate storage of biological reagents with
requisite monitoring of storage conditions to guarantee
continuous proper storage. Ensure the reliability of supply
systems, electrical power, and auxiliary support systems.
C. Provide protective garments, equipment, and sufficient
monitoring to assure safe handling of potentially hazardous
materials, including radioactive materials.
D. Conduct work under this contract in accordance with all
applicable Federal, state, and local laws, codes, ordinances,
and regulations.
VIII. OBTAIN CLEARANCE FOR PUBLICATION.
Provide an advance copy of draft manuscripts (including abstracts and
public presentations) resulting from thiscontract to the Project
Officer and obtain clearance in writing before submitting for
publication or presentation. Support from the Government contract
shall be acknowledged in all abstracts, presentations, and
publications.
IX. ENSURE AN ORDERLY TRANSITION TO A SUCCESSOR CONTRACTOR.
A. Refine and implement procedures for an orderly transition of
data and materials, including volunteer specimens, volunteer
specimen-derived materials, a computerized inventory of
volunteer specimens and specimen-derived materials,
Government-furnished reagents and Government-owned equipment,
to a successor Contractor or to the Government, subject to
Project Officer approval, by the end of the sixth year of this
contract. Deliver, if requested by the Project Officer and by
the completion date of the Contract, the following items:
Original data (electronic and paper files), preserved
Government- furnished reagents, volunteer specimens, volunteer
specimen-derived materials,a computerized inventory of the
volunteer specimens and volunteer specimen-derived materials,
any necessary information related thereto, and Government-owned
equipment and property.
B. Provide 2 weeks of instruction at the Contractor's site for
three members of the successor Contractor's staff in the
laboratory techniques employed during the period of this
contract should another laboratory be designated as the
successor Contractor.
Statement of Work ATTACHMENT A
(7/1/98) Page 6
Contract No. N01-AI-85341
INVOICE/FINANCING REQUEST AND FINANCIAL REPORTING
-------------------------------------------------
INSTRUCTIONS FOR NIH COST-REIMBURSEMENT TYPE 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: (l) 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
NIH(RC)-4 ATTACHMENT B
Rev. 5/97 Page 1
Contract No. N01-AI-85341
the explanatory notes below. These notes are keyed to the entries on the
sample invoice/financing request.
(a) Designated Billing Office Name and Address - Enter the designated
billing office name 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 contractor's name (as it appears in
the contract), correct address, and the title and phone number of the
responsible official to whom payment is to be sent. When an approved
assignment has been made by the contractor, or a different payee has
been designated, then insert the name and address of the payee instead
of the contractor.
(f) Total Estimated Cost of Contract - Insert the total estimated cost of
the contract, exclusive of fixed-fee. For incrementally funded
contracts, enter the amount currently obligated and available for
payment.
(g) Total Fixed-Fee - Insert the total fixed-fee (where applicable). 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 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.
(l) 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 Contractor's Guide for Control
of Government Property). Show permanent research equipment
separate from general purpose equipment. Prepare and attach
Form HHS-565, "Report of Accountable Property," in accordance
with the following instructions:
List each item for which reimbursement is requested. A
reference shall be made to the following (as applicable):
- 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.
NIH(RC)-4 ATTACHMENT B
Rev. 5/97 Page 2
Contract No. N01-AI-85341
- Be preceded by an asterisk (*) if the equipment is
below the approval level.
(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 B
Rev. 5/97 Page 3
Contract No. N01-AI-85341
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 Perentage of Effort/Hrs. - Actual - Enter the percentage
of effort or umber 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 contract 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 (Funds) 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.
Expendutres 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
and will be explained along with those identified under H above.
NIH(RC)-4 ATTACHMENT B
Rev. 5/97 Page 4
Contract No. N01-AI-85341
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)
NIH(RC)-4 ATTACHMENT B
Rev. 5/97 Page 5
Contract No. N01-AI-85341
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 D
OMB Bulletin 81-16
Contract No. N01-HB-87144
DETAILED TABLE OF CONTRACT CONTENTS
-----------------------------------
PART I - THE SCHEDULE
- ---------------------
SECTION A - SOLICITATION/CONTRACT FORM................................1
--------------------------------------
SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS.....................4
-------------------------------------------------
ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES.......4
ARTICLE B.2. ESTIMATED COST AND FIXED FEE....................4
ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS...........4
ARTICLE B.4. ADVANCE UNDERSTANDINGS..........................5
SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT.................6
-----------------------------------------------------
ARTICLE C.1. STATEMENT OF WORK...............................6
ARTICLE C.2. REPORTING REQUIREMENTS..........................8
SECTION D - PACKAGING, MARKING AND SHIPPING...........................9
-------------------------------------------
SECTION E - INSPECTION AND ACCEPTANCE.................................9
-------------------------------------
SECTION F - DELIVERIES OR PERFORMANCE.................................9
-------------------------------------
ARTICLE F.1. DELIVERIES......................................9
ARTICLE F.2. CLAUSES INCORPORATED BY REFERENCE..............10
SECTION G - CONTRACT ADMINISTRATION DATA.............................11
----------------------------------------
ARTICLE G.1. PROJECT OFFICER................................11
ARTICLE G.2. KEY PERSONNEL..................................11
ARTICLE G.3. INVOICE SUBMISSION/CONTRACT FINANCING
REQUEST AND CONTRACT FINANCIAL REPORT..........11
ARTICLE G.4. CONTRACT FINANCIAL REPORT......................12
ARTICLE G.5. INDIRECT COST RATES............................12
ARTICLE G.6. GOVERNMENT PROPERTY............................12
ARTICLE G.7. POST AWARD EVALUATION OF PAST PERFORMANCE......13
SECTION H - SPECIAL CONTRACT REQUIREMENTS............................13
-----------------------------------------
ARTICLE H.1. REIMBURSEMENT OF COSTS FOR INDEPENDENT
RESEARCH AND DEVELOPMENT PROJECTS..............13
ARTICLE H.2. HUMAN SUBJECTS.................................14
ARTICLE H.3. CONTINUED BAN ON FUNDING OF HUMAN EMBRYO
RESEARCH.......................................14
ARTICLE H.4. NEEDLE EXCHANGE................................14
ARTICLE H.5. SALARY RATE LIMITATION LEGISLATION PROVISIONS..14
ARTICLE H.6. PUBLICATION AND PUBLICITY......................15
ARTICLE H.7. PRESS RELEASES.................................15
ARTICLE H.8. REPORTING MATTERS INVOLVING FRAUD,
WASTE AND ABUSE................................15
PART II
- -------
SECTION I - CONTRACT CLAUSES.........................................16
----------------------------
ARTICLE I.1. GENERAL CLAUSES FOR A COST-REIMBURSEMENT
RESEARCH AND DEVELOPMENT CONTRACT..............16
ARTICLE I.2. AUTHORIZED SUBSTITUTION OF CLAUSES.............19
ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES....................19
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Contract No. N01-HB-87144
PART III
- --------
SECTION J - LIST OF ATTACHMENTS......................................20
-------------------------------
1. Invoice/Financing Request Instructions for NIH
Cost-Reimbursement Type Contracts.........................20
2. Financial Report of Individual Project/Contract...........20
3. Instructions for Completing form NIH 2706, Financial
Report of Individual Project/Contract.....................20
4. Safety and Health.........................................20
5. Procurement of Certain Equipment, NIH(RC)-7...............20
6. Contractor-Acquired Government Property - Schedule I-B....20
7. Property Acquired Under Predecessor Contract -
Schedule II-A.............................................20
PART IV
- -------
SECTION K - REPRESENTATIONS AND CERTIFICATIONS.......................21
----------------------------------------------
Representations and Certifications...........................21
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Contract No. N01-HB-87144
SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS
- -------------------------------------------------
ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES
- -------------------------------------------------------
The objectives of this project are to maintain a repository of blood specimens
from NHLBI-sponsored studies and to make appropriate specimens available to the
scientific community for use in research related to transfusion-transmitted
diseased and a variety of other disorders of blood or the cardiovascular
system.
ARTICLE B.2. ESTIMATED COST AND FIXED FEE
- ------------------------------------------
a. The estimated cost of this contract is $__________.
b. The fixed fee for this contract is $________. 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 fixed fee, is $2,901,590.
d. Total funds currently available for payment and allotted to this
contract are $377,835, of which $356,448 represents the estimated
costs, and of which $21,387 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 June 14, 1999.
f. The Contracting Officer may allot additional funds to the contract
without the concurrence of the Contractor.
g. Future increments to be allotted to this contract are estimated as
follows:
Period Amount
------ ------
June 15, 1999 through June 14, 2000 $ 461,262
June 15, 2000 through June 14, 2001 481,974
June 15, 2001 through June 14, 2002 503,693
June 15, 2002 through June 14, 2003 526,469
June 15, 2003 through June 14, 2004 550,357
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, 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.);
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Contract No. N01-HB-87144
(4) Travel to attend general scientific meetings;
(5) Foreign travel;
(6) Patient care costs;
(7) 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.
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.
a. Consultants
-----------
Consultant fees to be paid to the following individuals:
---------------
b. Repository Relocation
---------------------
A transition phase (June 15, 1998 through December 15, 1998) is
provided for relocation of the NHLBI biological specimen repository
from McKesson BioServices, 685 Loftstrand Lane, Rockville, Maryland
20850 to the repository facility operated by BBI-Biotech Research
Laboratories, Inc., 217 Perry Parkway, Gaithersburg, Maryland. The
Contractor shall complete interior fit out of the NHLBI repository
space, located at 217 Perry Parkway, Gaithersburg, Maryland, so as to
allow for a safe and orderly transition of the NHLBI biological
specimen repository from McKesson BioServices to the new location. The
Contractor shall transfer all Government-owned NHLBI freezers,
biological specimens, files, and inventory records, on or before
December 15, 1998. Repository relocation costs shall not exceed
$23,932.
c. Confidential Treatment of Sensitive Information
-----------------------------------------------
The Contractor shall guarantee strict confidentiality of the
information/data that it is provided by the Government during the
performance of the contract. The Government has determined that the
information/data that the Contractor will be provided during the
performance of the contract is of a sensitive nature and cannot be
disclosed in any manner.
Disclosure of the information/data, in whole or in part, by the
Contractor can only be made after the Contractor receives prior written
approval from the Contracting Officer. Whenever the Contractor is
uncertain with regard to the proper handling of information/data under
the contract, the Contractor shall obtain a written determination from
the Contracting Officer.
SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT
- -----------------------------------------------------
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Contract No. N01-HB-87144
ARTICLE C.1. STATEMENT OF WORK
- -------------------------------
a. Independently and not as an agent of the Government, the Contractor
shall furnish all the necessary services, qualified personnel,
material, equipment, and facilities, not otherwise provided by the
Government as needed to perform the Statement of Work below:
PHASE I - Transition
- --------------------
The contractor shall coordinate an orderly and safe transition from the current
incumbent contractor site to the new location, including the transport of
stored specimens, data, and all Government-furnished property. Contractor
shall adhere to the moving plan previously approved by the Department of
Transportation (DOT). This approval allows for the exemption from the
requirements of 46 CFR Part 64 regarding Federal hazardous material
transportation law so that specimens shall be moved in the freezers in which
they are stored.
Relocation of the NHLBI repository from McKesson BioServices, 685 Lofstrand
Lane, Rockville, MD 20850 to the Contractor's facility at 217 Perry Parkway,
Gaithersburg, Maryland 20877 shall be completed before December 15, 1998. At
the time of repository relocation, it is estimated that 2.8 million specimens
will be stored in 98 freezers and 5 liquid nitrogen tanks.
PHASE II Repository Maintenance
- ----------------------------------
Task 1 - Maintain Serum, Plasma, and Cell Repository
- ----------------------------------------------------
The contractor shall provide facilities and equipment to receive, store,
aliquot, and distribute potentially hazardous biologics such as serum, plasma,
and cells from individuals infected with AIDS virus and hepatitis viruses. The
facilities must provide aseptic and/or sterile conditions as appropriate
(Biosafety Level 2 Containment). The specimens shall be maintained by the
contractor in freezers at temperatures between -70 degrees and -80 degrees
centigrade. Freezers shall be located in an air-conditioned facility with
temperatures maintained between 20 degrees and 25 degrees centigrade (60
degrees to 77 degrees F) when freezers are in operation. The contractor shall
supply uninterruptible power to accommodate the refrigerators/freezers and
other equipment. Freezers shall be connected to a central alarm system
monitored twenty-four hours per day. The contractor shall provide an automated
temperature monitoring system composed of individual temperature probes
monitored 24 hours a day and controlled by a master computer, and a plan to
ensure that necessary personnel are notified in the event of freezer
malfunction. Emergency standby freezers shall be available in case of
mechanical failure of any portion of storage space. In addition, alternative
emergency freezer cooling systems such as a liquid nitrogen system or dry ice
must be available. The contractor must have backup electric generators capable
of operating all storage equipment for at least 48 hours in the event of
utility company power failure. Backup generators must be tested monthly. Cell
specimens (or tissues) shall be maintained at liquid nitrogen gas phase, in
special liquid nitrogen chests.
In order to accommodate the estimated increase of the number of specimens/vials
contained in the repository and the replacement of obsolete freezers, the
contractor shall purchase approximately six freezers per year, using contract
funds. The estimated increase in vials will result from the splitting of
specimens and arrival of new specimens.
Task 2 - Preparing Aliquots from Selected Specimens *
- -----------------------------------------------------
The contractor shall provide laboratory facilities and personnel for dividing
the serum or plasma samples into aliquots. All requests for samples are
reviewed by the NHLBI. Once an original specimen is identified for
distribution, it is thawed
5
Contract No. N01-HB-87144
and divided into aliquots, one of which is sent to the investigator, and the
remaining aliquots refrozen for later use. It is estimated that approximately
1,000 specimens shall be divided into 10,000 aliquots annually.
Thus, the size of the repository increases regularly as original specimens are
divided and distributed and new specimens are added to the repository. The
handling of all biological specimens and Government-owned property under this
contract shall be in accordance with all applicable local, state, and federal
regulations. In addition, in order to provide safety controls for protection to
the life and health of employees and other persons, the contractor shall
consult, comply with, and include in all applicable subcontracts, the following
standards, as appropriate:
1) Biosafety in Microbiological and Biomedical Laboratories, U.S.
Department of Health and Human Services, Centers for Disease Control
(CDC) and the NIH, DHHS Pub. No. (CDC) 93-8395.
2) Occupational Safety and Health Administration (OSHA), Publication 29
CFR Part 1910.1030, Occupational Exposure to Blood Borne Pathogens,
Final Rule.
Task 3 -Prepare and Ship Panels of Aliquots or Specimens *
- ----------------------------------------------------------
The Project Officer receives and reviews requests from investigators for
specimens or panels of aliquots. When a request is approved, the NHLBI Project
Officer will design panels of aliquots or specimens on the basis of the
investigator's experimental needs. On the basis of that design, the Project
Officer will provide to the contractor the information needed to prepare and
ship each panel. It is estimated that preparation and shipment of
approximately 50 panels, containing 100 vials each, will be required annually.
A list identifying the specimens to be included in a panel will be provided to
the contractor.
The contractor shall prepare the panels as required by the Project Officer.
Shipments will require preparation of the panel, packing the panel in dry ice,
packaging the panel in insulated boxes, and express shipment (usually by air)
to the final destination (specifically, the approved investigator). The
contractor shall ship all vials C.O.D.; transportation and postage costs are to
be paid by the recipients from point of carrier receipt. The contractor shall
verify receipt of the panel by the investigator both in writing and by phone.
Packaging and shipment shall meet standards for biologically hazardous
materials (see publication prepared by the International Air Transport
Association (IATA), Dangerous Goods Regulations, current edition).
Task 4 - Add Specimens to the Repository *
- ------------------------------------------
The contractor shall inventory, prepare for storage, package, and label, as
necessary, specimens to be added to the repository. The project officer will
specify the dates of arrival of such specimens, the number of specimens, and
the means of packaging, labeling and storing these samples as well as the type,
number and location of freezers to be relocated to the contractor's site. It
is essential that shipments be coordinated by the contractor so that personnel
will be available to receive the arriving packages and transport shipment to
the NHLBI repository for storage at the required temperature.
Task 5 - Performance of Virologic and Serologic Assays *
- --------------------------------------------------------
The contractor shall provide the capability to perform (in-house or through a
subcontractor) serologic and virologic assays for the evaluation and validation
of candidate blood screening tests for the detection of transfusion-associated
agents. For this purpose, laboratory biosafety level 2 shall be required, as
well as laboratory personnel with specific training in handling pathogenic
agents.
Laboratory personnel, safety practices, and techniques shall be supplemented by
appropriate facility design and engineering features, safety equipment, and
management practices. The contractor shall ensure that persons working with
these infectious agents are aware of potential hazards and strictly adhere to
standard microbiological practices and techniques. Costs for these assays will
be negotiated and the contract amount increased as the need arises.
The human pathogens for which blood screening tests are being developed or
improved and, therefore, are likely to be involved in future assay evaluation
and validation procedures, include hepatitis viruses, human retroviruses, and
agents of
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Contract No. N01-HB-87144
transmissible spongiform encephalopathies. Among the serologic and virologic
test formats that the contractor is expected to perform are enzyme
immunoassays, polymerase chain reactions, immunoblotting, and in situ
hybridization. It is expected that 500 - 1,000 assays will be required per
year.
Task 6 - Inventory Control
- --------------------------
The contractor shall update and maintain a computerized inventory control data
base using a desktop personal computer system to track and assist in the
coordination of the activities under this contract. At the time of contract
award, the FoxPro data base will contain information on approximately 2.1
million specimens. This will provide inventory and management information to
reflect activities of the repository, i.e., location of specimens, aliquoting
of specimens, preparation of panels, and addition of new specimens. In
addition, the SAS/Repository Management System (RMS) inventory and management
data base shall reflect activities on approximately 700,000 specimens including
location of specimens, aliquoting of specimens, preparation of panels, addition
of new specimens, and results of assays performed by outside investigators
using NHLBI specimens. The SAS software and license shall be provided to the
contractor by the Government.
Task 7 - Ensure an Orderly Transition of the NHLBI Biological Specimen
- -----------------------------------------------------------------------
Repository to a Successor Contractor
------------------------------------
In the event there is a recompetition of the subject contract and an
organization other than the incumbent is selected for contract award, incumbent
shall assist in ensuring an orderly and safe transition of the repository from
the current location at (address of repository at time of relocation) to any
successor of this contract. This shall include providing repository access to
the new contractor at mutually agreed upon times.
* SPECIAL TRAINING REQUIREMENTS:
------------------------------
Repository personnel involved in tasks 2, 3, 4, and 5 shall have
specific training in handling pathogenic agents and dealing with
potential hazards of the pathogens likely to be involved in the
operation of the repository.
ARTICLE C.2. REPORTING REQUIREMENTS
- ------------------------------------
a. Technical Reports
-----------------
In addition to those 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:
The Contractor shall submit to the Contracting Officer and to the
Project Officer technical progress reports covering the work
accomplished during each reporting period. These reports are subject
to technical inspection and requests for clarification by the Project
Officer. These shall be brief and factual and prepared in accordance
with the following format:
1. Quarterly Progress Report: This report shall include
descriptive information on activities in the repository during
the reporting period. The reporting period consists of the
first full three months of performance plus any fractional part
of the initial month. The first report shall be due September
30, 1998. Thereafter, the reporting period shall consist of
three full calendar months. This report shall include the
following:
a. the number of vials stored on the first and last days
of the reporting period;
b. the number of vials prepared during the reporting
period;
c. a list of panels prepared and shipped during the
reporting period including, for each panel:
1) number of specimens (vials),
2) date of shipment,
3) date of receipt of shipment, and
4) problems with any shipment;
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Contract No. N01-HB-87144
d. maintenance problems encountered and corrective actions
taken;
e. needs for replacement or repair of government-furnished
equipment; and
2. Final Report: Cumulative information for period of performance
of all information included in quarterly progress reports.
SECTION D - PACKAGING, MARKING AND SHIPPING
- -------------------------------------------
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.
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:
Division of Blood Diseases & Resources
National Heart, Lung, & Blood Institute
6701 Rockledge Drive, MSC 7950, Room 10146
Bethesda, MD 20892-7950
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 No. 52.246-5, INSPECTION OF SERVICES-COST REIMBURSEMENT
(APRIL 1984).
SECTION F - DELIVERIES OR PERFORMANCE
- -------------------------------------
ARTICLE F.1. 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 following items in accordance with
the stated delivery schedule.
b. The items specified below as described in SECTION C, ARTICLE C.1 and
ARTICLE C.2. 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 accordance with and by the dates specified below:
8
Contract No. N01-HB-87144
Item Description Quantity Delivery Schedule
- ---- ----------- -------- -----------------
1. Quarterly 2 copies to the Project Quarterly during
Progress Officer (PO), period of
Report 1 copy to the Contracting performance
Officer (CO)
2. Final 2 copies to the Project On or before
Report Officer (PO) expiration of
1 copy to the Contracting contract
Officer (CO)
3. All stored biological To be determined On or before
specimens, data files, expiration of
computerized listings of contract
accurate and updated
information on inventory,
data bases, original
data, and any necessary
information related
thereto
Copies of reports shall be sent to the following addresses:
<TABLE>
<CAPTION>
Project Officer - 2 copies AND Contracting Officer - 1 copy
- -------------------------- ----------------------------
<S> <C>
Blood Resources Program BDR Contracts Section
Division of Blood Diseases & Resources Contracts Operations Branch
National Heart, Lung, & Blood Institute National Heart, Lung, & Blood Institute
6701 Rockledge Drive, MSC 7950, Room 10146 6701 Rockledge Drive, MSC 7902, Room 6140
Bethesda, MD 20892-7950 Bethesda, MD 20892-7902
Federal Express and Couriers: Federal Express and Couriers:
6701 Rockledge Drive 6701 Rockledge Drive
Rockledge 2, 10th Floor, Room 10146 Rockledge Two, 6th Floor, Room 6140
Bethesda, MD 20817 Bethesda, MD 20817
</TABLE>
ARTICLE F.2. 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).
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Contract No. N01-HB-87144
SECTION G - CONTRACT ADMINISTRATION DATA
- ----------------------------------------
ARTICLE G.1. PROJECT OFFICER
- -----------------------------
The following Project Officer will represent the Government for the purpose of
this contract:
Luiz H. Barbosa, D.V.M.
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 is considered to be essential to the work being performed
hereunder:
NAME TITLE
---- -----
Mark Cosentino, Ph.D. Principal Investigator
ARTICLE G.3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST
- -----------------------------------------------------------
a. Invoice/Financing Request Instructions 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 as follows:
An original and two copies to the following designated billing
office:
Contracting Officer
BDR Contracts Section, Contracts Operations Branch
National Heart, Lung, and Blood Institute, NIH
RKL2, Room 6140
6701 ROCKLEDGE DRIVE, MSC 7902
BETHESDA MD 20892-7902
(2) Inquiries regarding payment of invoices should be directed to
the designated billing office, (301) 435-0359.
b. The Contractor shall include the following certification on every
invoice for reimbursable costs incurred with Fiscal
10
Contract No. N01-HB-87144
Year funds subject to the salary rate limitation provisions as specified in
ARTICLE H.5. of this contract. For billing purposes, certified invoices are
required for the billing period during which the applicable Fiscal Year funds
were initially charged through the final billing period utilizing the
applicable Fiscal Year funds:
"I hereby certify that the salaries charged in this invoice are in
compliance with P.L. [cite the applicable Public Law Number for the
applicable Fiscal Year as stated in ARTICLE H.5.] and ARTICLE H.5. of
the above referenced contract."
ARTICLE G.4 . CONTRACT FINANCIAL REPORT
- ----------------------------------------
a. Financial reports on the attached Form NIH 2706, Financial Report of
Individual Project/Contract, shall be submitted by the Contractor in
accordance with the Instructions for Completing Form NIH 2706, which
accompany the form, in an original and two copies, not later than the
30th working day after the close of the reporting period. The line
entries for subdivisions of work and elements of cost (expenditure
categories) which shall be reported within the total contract are
listed in paragraph e., below. Subsequent changes and/or additions in
the line entries shall be made in writing.
b. Unless otherwise stated in that part of the Instructions for Completing
Form NIH 2706, entitled "PREPARATION INSTRUCTIONS," all columns A
through J, shall be completed for each report submitted.
c. The first financial report shall cover the period consisting of the
FIRST FULL THREE CALENDAR MONTHS following the date of the contract, in
addition to any fractional part of the initial month. Thereafter,
reports will be on a quarterly basis.
d. The Contracting Officer may require the Contractor to submit detailed
support for costs contained in one or more interim financial reports.
This clause does not supersede the record retention requirements in FAR
Part 4.7.
e. The listing of expenditure categories to be reported is incorporated
within the Financial Report of Individual Project/Contract, NIH 2706,
SECTION J, ATTACHMENT 2, attached hereto and made a part of this
contract.
f. The Government may unilaterally revise the NIH 2706 to reflect the
allotment of additional funds.
ARTICLE G.5. 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:
Division of Financial Advisory Services
Office of Contract Management
National Institutes of Health
6100 EXECUTIVE BLVD ROOM 6B05
BETHESDA MD 20892
These rates are hereby incorporated without further action of the Contracting
Officer.
ARTICLE G.6 . 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
11
Contract No. N01-HB-87144
Administrator.
This contract's Contract Property Administrator is:
Marea Petrelles
Contracts Property Administrator
Research Contracts Property Administration, NIH
6011 Executive Blvd., Room 641E
ROCKVILLE MD 20852-7670
(301) 496-6466
b. Contractor-Acquired Government Property - Schedule I-B
------------------------------------------------------
Pursuant to the Clause, GOVERNMENT PROPERTY, incorporated in this
contract, the Contractor shall be authorized to acquire the property
listed in Schedule I-B for use in direct performance of the contract,
following receipt of the Contracting Officer's written approval, based
on contractor-furnished prices and evidence of competition.
c. Property Acquired Under Predecessor Contract - Schedule II-A
------------------------------------------------------------
Pursuant to the clause, GOVERNMENT PROPERTY, incorporated in this
contract, the Contractor shall be authorized, at the time of relocation
of the NHLBI Biological Specimen Repository , to obtain custody of all
Government Property listed in the attached Schedule II-A for use in
direct performance of this contract. Accountability for the items
listed in Schedule II-A shall be transferred, at the time of relocation
of the NHLBI Biological Specimen Repository, to this contract from the
predecessor Contract No. N01-HB017087, under which these items were
provided by the Government. Title to this property shall remain in the
Government.
ARTICLE G.7. 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.
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.1. REIMBURSEMENT OF COSTS FOR INDEPENDENT RESEARCH AND DEVELOPMENT
- -----------------------------------------------------------------------------
PROJECTS
--------
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
12
Contract No. N01-HB-87144
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 . HUMAN SUBJECTS
- -----------------------------
It is hereby understood and agreed that research involving human subjects shall
not be conducted under this contract, and that no material developed, modified,
or delivered by or to the Government under this contract, or any subsequent
modification of such material, will be used by the Contractor or made available
by the Contractor for use by anyone other than the Government, for experimental
or therapeutic use involving humans without the prior written approval of the
Contracting Officer.
ARTICLE H.3. CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH
- ---------------------------------------------------------------
Section 513 of the Fiscal Year 1998 Appropriations Act (P.L. 105-78) prohibits
NIH from using appropriated funds to support human embryo research. Contract
funds may not be used for (1) the creation of a human embryo or embryos for
research purposes; or (2) research in which a human embryo or embryos are
destroyed, discarded, or knowingly subjected to risk of injury or death greater
than that allowed for research on fetuses in utero under 45 CFR 46.208(a)(2)
and Section 498(b) of the Public Health Service Act (42 U.S.C . 289g(b)). The
term "human embryo or embryos" includes any organism, not protected as a human
subject under 45 CFR 46 as of the date of the Act, that are derived by
fertilization, parthenogenesis, cloning, or any other means from one or more
human gametes or human diploid cells.
Additionally, in accordance with a March 4, 1997 Presidential Memorandum,
Federal funds may not be used for cloning of human beings.
ARTICLE H.4. NEEDLE EXCHANGE
- -----------------------------
Pursuant to Section 505 of Public Law 105-78, 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. Section 505, however, is subject to
the condition stated in Section 506. Specifically, Section 506 states that
after March 31, 1998, a program for exchanging needles and syringes for used
hypodermic needles and syringes may be carried out in a community if: (1) the
Secretary of Health and Human Services determines that exchange projects are
effective in preventing the spread of HIV and do not encourage the use of
illegal drugs; and (2) the project is operated in accordance with criteria
established by the Secretary for preventing the spread of HIV and for ensuring
that the project does not encourage the use of illegal drugs.
ARTICLE H.5. SALARY RATE LIMITATION LEGISLATION PROVISIONS
- -----------------------------------------------------------
a. Pursuant to Public Law(s) cited in paragraph b., below, no NIH Fiscal
Year funds for the applicable fiscal year(s) and periods cited in
paragraph b., below may be used to pay the direct salary of an
individual through this contract at a rate in excess of applicable
amount shown for the fiscal year and period covered. Direct salary is
exclusive of overhead, fringe benefits and general and administrative
expenses. The per year salary rate limit also applies to individuals
proposed under subcontracts. If this is a multi-year contract, it may
be subject to unilateral modifications by the Government if an
individual's salary rate exceeds any salary rate ceiling established in
future DHHS appropriation acts.
b. Dollar Amount of
Public Law No. Fiscal Year Period Covered Salary Limitation
-------------- ----------- -------------- -----------------
105-78 1998 10/01/1997-09/30/1998 $125,000
ARTICLE H.6. PUBLICATION AND PUBLICITY
- ---------------------------------------
13
Contract No. N01-HB-87144
The contractor shall acknowledge the support of the National Institutes of
Health whenever publicizing the work under this contract in any media by
including an acknowledgment substantially as follows:
"This project has been funded in whole or in part with Federal funds
from the National Heart, Lung, and Blood Institute, National Institutes
of Health, under Contract No. N01-HB-87144."
ARTICLE H.7. PRESS RELEASES
- ----------------------------
Pursuant to Section 508 of Public Law 105-78, the contractor shall clearly
state, when issuing statements, press released, requests for proposals, bid
solicitations and other documents describing projects or programs funded in
whole or in part with Federal money that: (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 nongovernment sources.
ARTICLE H.8. 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
HHS inspector General's Office in writing or on the Inspector General's
Hotline. The toll free number is 1-800-HHS-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).
14
Contract No. N01-HB-87144
PART II
-------
SECTION I - CONTRACT CLAUSES
- ----------------------------
ARTICLE I.1. GENERAL CLAUSES FOR A COST-REIMBURSEMENT RESEARCH AND DEVELOPMENT
- -------------------------------------------------------------------------------
CONTRACT - FAR 52.252-2, CLAUSES INCORPORATED BY REFERENCE (FEBRUARY 1998)
- --------------------------------------------------------------------------
This contract incorporates the following clauses by reference, with the same
force and effect as if they were given in full text. Upon request, the
Contracting Officer will make their full text available. Also, the full text
of a clause may be accessed electronically at this address:
http://www.arnet.gov/far/.
a. FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES:
FAR
CLAUSE NO. TITLE AND DATE
52.202-1 Definitions (OCTOBER 1995)
52.203-3 Gratuities (Over $100,000) (APRIL 1984)
52.203-5 Covenant Against Contingent Fees (Over $100,000) (APRIL
1984)
52.203-6 Restrictions on Subcontractor Sales to the Government
(Over $100,000) (JULY 1995)
52.203-7 Anti-Kickback Procedures (Over $100,000) (JULY 1995)
52.203-8 Cancellation, Rescission, and Recovery of Funds for
Illegal or Improper Activity (Over $100,000) (JANUARY
1997)
52.203-10 Price or Fee Adjustment for Illegal or Improper
Activity (Over $100,000) (JANUARY 1997)
52.203-12 Limitation on Payments to Influence Certain Federal
Transactions (Over $100,000) (JUNE 1997)
52.204-4 Printing/Copying Double-Sided on Recycled Paper (Over
$100,000) (JUNE 1996)
52.209-6 Protecting the Government's Interests when
Subcontracting with Contractors Debarred, Suspended, or
Proposed for Debarment (Over $25,000) (JULY 1995)
52.215-2 Audit and Records - Negotiation (Over $100,000) (AUGUST
1996)
52.215-8 Order of Precedence-Uniform Contract Format (OCTOBER
1997)
52.215-10 Price Reduction for Defective Cost or Pricing Data
(Over $500,000) (OCTOBER 1997)
52.215-12 Subcontractor Cost or Pricing Data (Over $500,000)
(OCTOBER 1997)
52.215-14 Integrity of Unit Prices (Over $100,000) (OCTOBER 1997)
52.215-15 Termination of Defined Benefit Pension Plans (OCTOBER
1997)
52.215-18 Reversion or Adjustment of Plans for Post-Retirement
Benefits (PRB) other than Pensions (OCTOBER 1997)
15
Contract No. N01-HB-87144
52.215-19 Notification of Ownership Changes (OCTOBER 1997)
52.215-21 Requirements for Cost or Pricing Data or Information
Other Than Cost or Pricing Data--Modifications (OCTOBER
1997)
52.216-7 Allowable Cost and Payment (APRIL 1998)
52.216-8 Fixed Fee (MARCH 1997)
52.219-8 Utilization of Small, Small Disadvantaged, and
Women-Owned Small Business Concerns (Over $100,000)
(JUNE 1997)
52.219-9 Small, Small Disadvantaged, and Women-Owned Small
Business Subcontracting Plan (Over $500,000) (AUGUST
1996)
52.219-16 Liquidated Damages - Subcontracting Plan (Over
$500,000) (OCTOBER 1995)
52.222-2 Payment for Overtime Premium (Over $100,000) (JULY
1990) (NOTE: The dollar amount in paragraph (a) of this
clause is $0 unless otherwise specified in the
contract.)
52.222-3 Convict Labor (AUGUST 1996)
52.222-26 Equal Opportunity (APRIL 1984)
52.222-28 Equal Opportunity Preaward Clearance of Subcontracts
(Over $1,000,000) (APRIL 1984)
52.222-35 Affirmative Action for Disabled Veterans and Veterans
of the Vietnam Era (APRIL 1998)
52.222-36 Affirmative Action for Handicapped Workers (APRIL 1984)
52.222-37 Employment Reports on Disabled Veterans and Veterans of
the Vietnam Era (APRIL 1998)
52.223-2 Clean Air and Water (Over $100,000) (APRIL 1984)
52.223-6 Drug-Free Workplace (JANUARY 1997)
52.223-14 Toxic Chemical Release Reporting (OCTOBER 1996)
52.225-3 Buy American Act--Supplies (JANUARY 1994)
52.225-11 Restrictions on Certain Foreign Purchases (OCTOBER
1996)
52.227-1 Authorization and Consent (Over $50,000) (JULY
1995)--Alternate I (APRIL 1984)
52.227-2 Notice and Assistance Regarding Patent and Copyright
Infringement (Over $100,000) (AUGUST 1996)
52.227-11 Patent Rights - Retention by the Contractor (Short
Form) (JUNE 1997) NOTE: In accordance with FAR
27.303(a)(2),paragraph (f) is modified to include the
requirements in FAR 27.303(a)(2) (i) through (iv). The
frequency of reporting in (i) is annual.
16
Contract No. N01-HB-87144
52.227-14 Rights in Data - General (JUNE 1987)
52.232-9 Limitation on Withholding of Payments (APRIL 1984)
52.232-17 Interest (Over $100,000) (JUNE 1996)
52.232-20 Limitation of Cost (APRIL 1984)
52.232-23 Assignment of Claims (JANUARY 1986)
52.232-25 Prompt Payment (JUNE 1997)
52.232-33 Mandatory Information for Electronic Funds Transfer
Payment (AUGUST 1996)
52.233-1 Disputes (OCTOBER 1995)
52.233-3 Protest After Award (AUGUST 1996) With Alternate I
(JUNE 1985)
52.242-1 Notice of Intent to Disallow Costs (APRIL 1984)
52.242-3 Penalties for Unallowable Costs (Over $500,000)
(OCTOBER 1995)
52.242-4 Certification of Final Indirect Costs (JANUARY 1997)
52.242-13 Bankruptcy (Over $100,000) (JULY 1995)
52.243-2 Changes - Cost Reimbursement (AUGUST 1987) Alternate V
(APRIL 1984)
52.244-2 Subcontracts (Cost-Reimbursement and Letter Contracts)
(FEBRUARY 1997) *If written consent to subcontract is
required, the identified subcontracts are listed in
ARTICLE B, Advance Understandings.
52.244-5 Competition in Subcontracting (Over $100,000) (DECEMBER
1996)
52.245-5 Government Property (Cost-Reimbursement, Time and
Material, or Labor-Hour Contract) (JANUARY 1986)
52.246-23 Limitation of Liability (Over $100,000) (FEBRUARY 1997)
52.249-6 Termination (Cost-Reimbursement) (SEPTEMBER 1996)
52.249-14 Excusable Delays (APRIL 1984)
52.253-1 Computer Generated Forms (JANUARY 1991)
17
Contract No. N01-HB-87144
b. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR)
(48 CFR CHAPTER 3) CLAUSES:
HHSAR
CLAUSE NO. TITLE AND DATE
---------- --------------
352.202-1 Definitions (APRIL 1984) Alternate I (APRIL 1984)
352.228-7 Insurance - Liability to Third Persons (DECEMBER 1991)
352.232-9 Withholding of Contract Payments (APRIL 1984)
352.233-70 Litigation and Claims (APRIL 1984)
352.242-71 Final Decisions on Audit Findings (APRIL 1984)
352.270-5 Key Personnel (APRIL 1984)
352.270-6 Publication and Publicity (JULY 1991)
352.270-7 Paperwork Reduction Act (APRIL 1984)
End of GENERAL CLAUSES FOR A COST-REIMBURSEMENT RESEARCH AND DEVELOPMENT
CONTRACT ]
ARTICLE I.2 AUTHORIZED SUBSTITUTION OF CLAUSES
- -----------------------------------------------
ARTICLE I.1. of this SECTION is hereby modified as follows:
FAR Clause 52.232-20, LIMITATION OF COST, is deleted in its entirety and FAR
Clause 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, 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 52.223-3, Hazardous Material Identification and Material
Safety Data (JANUARY 1997), ALTERNATE I (JULY 1995).
(2) FAR 52.223-12, Refrigeration Equipment and Air Conditioners
(MAY 1995).
(3) FAR 52.232-18, Availability of Funds (APRIL 1984).
(4) FAR 52.237-3, Continuity of Services (JANUARY 1991).
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).
18
Contract No. N01-HB-87144
c. NATIONAL INSTITUTES OF HEALTH (NIH) RESEARCH CONTRACTING (RC) CLAUSES:
The following clause is attached and made a part of this contract:
(1) NIH (RC)-7, Procurement of Certain Equipment (APRIL 1984) (OMB
Bulletin 81-16).
19
Contract No. N01-HB-87144
PART III
--------
SECTION J - LIST OF ATTACHMENTS
-------------------------------
The following documents are attached and incorporated in this contract:
1. Invoice/Financing Request Instructions for NIH Cost-Reimbursement Type
Contracts, NIH(RC)-1 (5/97), 4 pages.
2. Financial Report of Individual Project/Contract, NIH 2706, (5/97), 1
page.
3. Instructions for Completing form NIH 2706, Financial Report of
Individual Project/Contract, (5/97), 3 pages.
4. Safety and Health (Deviation) , PHSAR Clause 352.223-70, (8/97), 1
page.
5. Procurement of Certain Equipment, NIH(RC)-7, 4/1/84, 1 page.
6. Contractor-Acquired Government Property - Schedule I-B, dated June
1998, 1 page.
7. Property Acquired Under Predecessor Contract, Schedule II-A, dated June
1998, 1 page.
20
Contract No. N01-HB-87144
PART IV
-------
SECTION K - REPRESENTATIONS AND CERTIFICATIONS
- ----------------------------------------------
The following documents are incorporated by reference in this contract:
1. Representations and Certifications, dated October 17, 1997. .
END of the CONTRACT
-------------------
21
Contract No. N01-HB-87144
Property Acquired Under Predecessor Contract
--------------------------------------------
Schedule II-A
-------------
June 1998
See attached DHHS Report of Accountable Property (HHS-565), dated 3/16/98 and
10/29/97.
Attachment 6
Contract No. N01-HB-87144
Contractor-Acquired Government Property
---------------------------------------
Schedule I-B
------------
June 1998
Estimated
Description Quantity Unit Price Total
- ----------- -------- ---------- -----
So-Low freezer cabinet 36 $ 6,650 $239,400
Model C80-27, temperature range -40 degrees C
to -80 degrees C, 27 cu. ft. capacity
Attachment 6
