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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 March 31, 1997, 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 0-21615
BOSTON BIOMEDICA, INC.
----------------------
(EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)
MASSACHUSETTS 04-2652826
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(State or other Jurisdiction of (I.R.S. Employer
Incorporation or Organization) Identification No.)
375 WEST STREET,
WEST BRIDGEWATER, MASSACHUSETTS 02379
------------------------------- -----
(Address of Principal Executive Offices) (Zip Code)
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.
[X] Yes [ ] No
The number of shares outstanding of the Registrant's only class of common
stock as of April 30, 1997 was 4,391,403.
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PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
BOSTON BIOMEDICA, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
<TABLE>
<CAPTION>
For the Three Months Ended
March 31,
--------------------------------------
1997 1996
------------------ -------------------
REVENUE:
<S> <C> <C>
Product sales $ 2,126,956 $ 1,815,481
Services 2,082,093 1,268,528
------------------ -------------------
Total revenue 4,209,049 3,084,009
COSTS AND EXPENSES:
Cost of product sales 1,055,422 899,826
Cost of services 1,475,532 1,133,439
Research and development 236,750 166,565
Selling and marketing 613,360 415,012
General and administrative 679,207 536,503
------------------ -------------------
Total operating costs and expenses 4,060,271 3,151,345
Income (loss) from operations 148,778 (67,336)
Interest income (expense), net 97,486 (93,560)
------------------ -------------------
Income (loss) before income taxes 246,264 (160,896)
(Provision for) benefit from income taxes (98,506) 64,358
------------------ -------------------
Net income (loss) $ 147,758 $ (96,538)
================== ===================
Net income (loss) per share $ .03 $ (0.04)
================== ===================
Weighted average common and common
equivalent shares outstanding 4,825,582 2,564,774
</TABLE>
See Notes to Consolidated Financial Statements.
2
BOSTON BIOMEDICA, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
<TABLE>
<CAPTION>
March 31, December 31,
--------- ------------
1997 1996
--------------- ------------------
ASSETS
CURRENT ASSETS:
<S> <C> <C>
Cash and cash equivalents $ 7,019,559 $ 8,082,642
Accounts receivable, less allowances of $362,612 in 1997 and
$352,058 in 1996 3,144,197 3,415,994
Inventories 4,461,582 4,180,334
Prepaid expense and other 316,634 239,950
Deferred income taxes 283,200 283,200
--------------- ------------------
Total current assets 15,225,172 16,202,120
--------------- ------------------
Property and equipment, net 2,937,354 2,699,158
OTHER ASSETS:
Long term investment 732,500 732,500
Goodwill and other intangibles, net 90,694 95,302
Notes receivable and other 795,409 69,234
--------------- ------------------
1,618,603 897,036
--------------- ------------------
TOTAL ASSETS $ 19,781,129 $ 19,798,314
=============== ==================
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES:
Current maturities of long term debt $ 13,136 $ 12,820
Accounts payable 1,146,988 991,839
Accrued compensation 521,023 840,666
Accrued income taxes 122,260 427,140
Other accrued expenses 331,228 264,262
Deferred revenue 1,056,531 829,477
--------------- ------------------
Total current liabilities 3,191,166 3,366,204
--------------- ------------------
LONG-TERM LIABILITIES:
Long-term debt, less current maturities 37,543 40,948
Deferred income taxes 101,580 101,580
COMMITMENTS AND CONTINGENCIES
STOCKHOLDERS' EQUITY
Common stock, $.01 par value; authorized 20,000,000 shares in
1997 and 1996; issued and outstanding 4,381,157 in 1997 and
4,378,157 in 1996 43,812 43,782
Additional paid-in capital 15,272,126 15,258,656
Retained earnings 1,134,902 987,144
--------------- ------------------
Total stockholders' equity 16,450,840 16,289,582
--------------- ------------------
TOTAL LIABILITIES & STOCKHOLDERS' EQUITY $ 19,781,129 $ 19,798,314
=============== ==================
</TABLE>
See Notes to Consolidated Financial Statements.
3
BOSTON BIOMEDICA, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
<TABLE>
<CAPTION>
For the Three Months Ended
March 31,
--------------------------------------
1997 1996
--------------- -----------------
CASH FLOWS FROM OPERATING ACTIVITIES:
<S> <C> <C>
Net income (loss) $ 147,758 $ (96,538)
Adjustments to reconcile net income to net
cash provided by operating activities:
Depreciation and amortization 166,774 120,632
Provision for doubtful accounts 10,554 7,338
Deferred rent (26,958) (16,618)
Changes in operating assets and liabilities:
Accounts receivable 261,243 661,915
Other assets - 1,421
Inventories (281,248) (154,374)
Prepaid expenses (76,684) (35,300)
Accounts payable 155,149 222,167
Accrued compensation and other expenses (530,599) (150,575)
Deferred revenue 227,054 229,185
--------------- -----------------
Net cash provided by operating activities 53,043 789,253
--------------- -----------------
CASH FLOWS FROM INVESTING ACTIVITIES:
Payments for additions to property and equipment (400,362) (116,257)
Advances under notes receivable and other assets (726,175) -
--------------- -----------------
Net cash used in investing activities (1,126,537) (116,257)
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CASH FLOWS FROM FINANCING ACTIVITIES:
Repayments of long-term debt (3,089) (675,285)
Proceeds of common stock issued 13,500 -
--------------- -----------------
Net cash provided by (used in) financing activities 10,411 (675,285)
--------------- -----------------
DECREASE IN CASH: (1,063,083) (2,289)
Cash, beginning of period 8,082,642 11,463
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Cash, end of period $ 7,019,559 $ 9,174
=============== =================
SUPPLEMENTAL INFORMATION:
Income taxes paid $ 403,842 $ 130,962
Interest paid $ 110 96,917
</TABLE>
See Notes to Consolidated Financial Statements.
4
(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 three months ended
March 31, 1997 are not necessarily indicative of the results that may be
expected for the year ending December 31, 1997. For further information, refer
to the consolidated financial statements and footnotes thereto included in the
Form 10-K filing for the fiscal year ended December 31, 1996 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) Inventories
Inventories consisted of the following:
March 31, December 31,
1997 1996
---- --------
Raw materials ..................... $ 1,392,297 $ 1,359,569
Work-in-process ................... 883,249 697,749
Finished goods .................... 2,186,036 2,123,016
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$ 4,461,582 $ 4,180,334
============== ==============
(3) Computation of Income (Loss) Per Share
Net income per common share is computed based upon the weighted average
number of common shares and as appropriate, common equivalent shares (using the
treasury stock method) outstanding after certain adjustments described below.
Common equivalent shares consist of common stock options and warrants
outstanding. In accordance with Securities and Exchange Commission Staff
Accounting Bulletin No. 83, all common, redeemable common, and common equivalent
shares issued during the twelve month period prior to the proposed date of the
initial filing of the Registration Statement have been included in the
calculation as if they were outstanding for all periods prior to the initial
public offering using the treasury stock method and an offering price of $8.50
per share. Fully diluted net income (loss) per common share is not presented as
it does not materially differ from primary earnings 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 is
currently required under the provisions of Accounting Principles Board Opinion
No. 15. Under SFAS No. 128, the Company will be required to present both basic
net income per share and diluted net income per share. Basic net income (loss)
per share for the quarters ended March 31, 1997 and 1996 would have been the
same as the reported primary net income (loss) per share. The impact of SFAS 128
on the calculation of diluted net income per share for these quarters does not
materially differ from basic net income (loss) per share. The Company plans to
adopt SFAS 128 for periods after December 15, 1997 and at that time all
historical net income per share data presented will be restated to conform to
the provisions of SFAS No. 128.
Subsequent Event
In April 1997, the Company exercised its option to purchase an additional
165,000 shares of BioSeq, Inc. stock at an aggregate cost of $750,750, thereby
increasing its ownership of BioSeq to 19%.
5
ITEM2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF RESULTS OF OPERATIONS AND
FINANCIAL CONDITION.
THREE MONTHS ENDED MARCH 31, 1997 AND 1996
Total revenue increased 36.5%, or $1,125,000, to $4,209,000 for the quarter
ended March 31, 1997 from $3,084,000 in the prior year period. This increase was
the result of an increase in product sales of 17.2%, or $312,000, to $2,127,000
from $1,815,000 and an increase in specialty laboratory services of 64.1%, or
$813,000, to $2,082,000 from $1,269,000. Product revenue increased primarily as
a result of an overall sales increase of 40.2% in Quality Control Products, due
to continued strong sales of new and existing of Accurun( and panel products.
This was partially offset by a decline of 36% in sales of Diagnostic Components
as certain custom orders were delayed. The increase in service revenue was
primarily attributable to a 74.3% increase in Specialty Clinical Laboratory
Testing revenue, particularly from Lyme Disease and the new HIV molecular tests.
Gross profit increased 59.7%, or $627,000, to $1,678,000 for the current
quarter from $1,051,000 in the prior year period. The gross profit margin
increased to 39.9% for the current quarter versus 34.1% in the prior year
period. The gross margin improvement was entirely driven by improved margins in
services (10.6% in 1996 to 29.1% in 1997) as the Company continued to benefit
from both the addition of several new tests and higher volume in Specialty
Clinical Laboratory Testing.
Research and development expenses increased 42.1%, or $70,000, to $237,000
for the current quarter from $167,000 in the prior year period. This increase
was primarily the result of additional research project expenditures for new
Quality Control Products, including panels and Accurun(, as well as continued
work on additional molecular tests for our Specialty Clinical Laboratory.
Selling and marketing expenses increased 47.8%, or $198,000, to $613,000 for
the current quarter from $415,000 in the prior year period. This increase was
primarily attributable to increased personnel costs associated with the addition
of both tele-sales and field staff, as well as technical support staff for
Quality Control Products, particularly Accurun(, increased advertising and trade
show costs for all the Company's products and services, and increased travel
costs.
General and administrative expenses increased 26.6%, or $143,000, to
$679,000 for the current quarter from $536,000 in the prior year period. This
increase was primarily a result of increased MIS and other support personnel, as
well as the increased costs incurred as a public company.
Net interest income of $97,000 was earned for the first quarter of 1997
versus a ($94,000) expense in the prior year period as the Company repaid most
of its debt in the fourth quarter of 1996 and invested its available cash in
short term, investment grade securities.
For both first quarters, the Company provided taxes at the combined federal
and state statutory rate of 40%.
LIQUIDITY AND FINANCIAL CONDITION
On October 31, 1996 the Company commenced trading as a result of its initial
public offering of its common stock ("IPO"), selling 1,600,000 shares at $8.50
per share. Net proceeds raised after underwriting discounts and commissions (but
before offering costs) was $12,648,000. On November 5, 1996, the Company repaid
substantially all of its outstanding bank debt which totaled approximately $3.9
million.
The Company has financed its operations to date through cash flow from
operations, borrowings from banks and sales of equity. With the repayment of
debt from the IPO proceeds, the Company expects its cash flow and cash position
to meet existing operational needs. In addition, the Company has available to it
a $7.5 million uncollateralized revolving line of credit with its bank should
additional needs arise.
Net cash provided by operations for the three months ended March 31, 1997
was $53,000 as compared to $789,000 in the prior year period. This decrease in
cash flow was primarily attributable to increased working capital requirements
and net payments of $531,000 during the first quarter of 1997 of expenses
accrued as of December 31, 1996 related to income taxes and commissions.
6
Cash used in investing activities for the three months ended March 31, 1997
was $1,127,000 as compared to $116,000 in the prior year period. This increase
in investing activities was the result of increased capital expenditures as the
Company began construction of improvements at its manufacturing facility, and
financed certain working capital needs in connection with its announced
acquisition of the assets of Source Scientific, Inc., scheduled for closing in
the second quarter of 1997 at an agreed upon cost of $2.1 million dollars,
subject to shareholder approval. In April 1997, the Company exercised its option
to purchase an additional 165,000 shares of BioSeq, Inc. stock at an aggregate
cost of $750,750, thereby increasing its ownership of BioSeq to 19%.
Cash provided by financing activities for the three months ended March 31,
1997 was $10,000 as compared to $675,000 used to repay debt in the prior
comparable year period. The net cash provided in 1997 resulted from $14,000
received for stock options exercises.
The Company anticipates capital expenditures to increase over the near term
as it expects to use approximately $750,000 from the proceeds of its IPO to
expand its manufacturing capacity in West Bridgewater over the next nine months.
The Company believes that existing cash balances, the borrowing capacity
available under its new revolving line of credit and cash generated from
operations are sufficient to fund operations and anticipated capital
expenditures for the foreseeable future. There were no material financial
commitments for capital expenditures as of March 31, 1997, and currently there
are no material commitments for capital or investment expenditures other than
the April BioSeq investment, the Source Scientific, Inc. asset acquisition, and
the manufacturing expansion, all as previously discussed above.
RECENT ACCOUNTING PRONOUNCEMENTS
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 is
currently required under the provisions of Accounting Principles Board Opinion
No. 15. Under SFAS No. 128, the Company will be required to present both basic
net income per share and diluted net income per share. Basic net income (loss)
per share for the quarters ended March 31, 1997 and 1996 would have been the
same as the reported primary net income (loss) per share. The impact of SFAS 128
on the calculation of diluted net income per share for these quarters does not
materially differ from basic net income (loss) per share. The Company plans to
adopt SFAS 128 for periods after December 15, 1997 and at that time all
historical net income per share data presented will be restated to conform to
the provisions of SFAS No. 128.
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; inability of
Source Scientific, Inc. to repay the $750,000 loan made by the Company; 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; 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).
7
BOSTON BIOMEDICA, INC.
PART II. OTHER INFORMATION
<TABLE>
<CAPTION>
ITEM 6. EXHIBITS AND REPORTS ON FORM 8K
(A) EXHIBITS
Exhibit No.
-----------
<S> <C>
3.1 Amended and Restated Articles of Organization of the Company**
3.2 Amended and Restated Bylaws of the Company**
4.1 Specimen Certificate for Shares of the Company's Common Stock**
4.2 Description of Capital Stock (contained in the Restated Articles of Organization of the Company
filed as Exhibit 3.1) **
10.1 Agreement, dated January 17, 1994, between Roche Molecular Systems, Inc. and the Company**
10.2 Exclusive License Agreement, dated December 6, 1994, between the University of North Carolina at
Chapel Hill and the Company**
10.3 Contract, dated September 30, 1995, between the National Institutes of Health and the Company (No.
1-AI55273) **
10.4 Contract, dated September 30, 1995, between the National Institutes of Health and the Company (No.
1-AI-55277) **
10.6 Agreement, dated October 1, 1995, between Ajinomoto Co., Inc. and the Company**
10.7 Lease Agreement, dated June 30, 1992, for Rockville, Maryland Facility between Cambridge Biotech
Corporation and the Company**
10.8 Lease Agreement, dated July 28, 1995, for New Britain, Connecticut Facility between MB Associates
and the Company**
10.9 Worcester County Institution for Savings Warrant dated December 1, 1995 (No. 1) **
10.10 Worcester County Institution for Savings Warrant dated July 26, 1993 (No. 2) **
10.11 Stock Purchase Agreement, dated June 5, 1990, between G&G Diagnostics Limited Partnership I and
the Company, as amended**
10.12 Purchase and Sale Agreement, dated December 11, 1995, for 375 West Street Property between James
Leonard, Trustee, C.W.B. Trust and the Company**
10.13 Purchase and Sale Agreement, dated December 20, 1995, for 80 Manley Street Property between the
Company and Donald M. Leonard, Trustee, Live Oak Realty Trust**
10.14 Stock Purchase Agreement, dated April 26, 1996, between Kyowa Medex Co., Ltd. and the Company**
10.15 1987 Non-Qualified Stock Option Plan**++
10.16 Employee Stock Option Plan**++
10.17 Underwriters Warrants, each dated November 4, 1996, between the Company and each of Oscar Grus &
Son Incorporated and Kaufman Bros., L.P. **
10.20 Purchase Agreement, dated October 7, 1996, between BioSeq, Inc. and the Company**
10.21 Warrant Agreement, dated October 7, 1996, between BioSeq, Inc. and the Company**
8
10.22 Stockholders' Agreement, dated October 7, 1996, between BioSeq, Inc. and the Company**
10.23 License Agreement, dated October 7, 1996, between BioSeq, Inc. and the Company**
10.24.1 Commercial Loan Agreement, dated as of March 28, 1997, between
The First National Bank of Boston and the Company**
10.25 Asset Purchase Agreement, dated March 26, 1997 between Source Scientific, Inc. and the Company**
10.26 Contract, dated March 1, 1997, between National Cancer Institute and the Company
11 Statement re: Computation of Per Share Earnings
21.1 Subsidiaries of the Company **
27 Financial Data Schedule
</TABLE>
- ------------------------
++ Management contract or compensatory plan or arrangement.
** 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 8K
None
9
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: May 14, 1997 By /s/ KEVIN W. QUINLAN
------------------------- -----------------------------------------
Kevin W. Quinlan, Chief Financial Officer
(Principal Financial Officer)
10
BOSTON BIOMEDICA, INC.
EXHIBIT INDEX
EXHIBIT INDEX
-------------
<TABLE>
<CAPTION>
Exhibit No. Reference
----------- ---------
<S> <C>
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 A**
Organization of the Company filed as Exhibit 3.1)
10.1 Agreement, dated January 17, 1994, between Roche Molecular Systems, Inc. and A**
the Company
10.2 Exclusive License Agreement, dated December 6, 1994, between the University of A**
North Carolina at Chapel Hill and the Company
10.3 Contract, dated September 30, 1995, between the National Institutes of Health A**
and the Company (No. 1-AI55273)
10.4 Contract, dated September 30, 1995, between the National Institutes of Health A**
and the Company (No. 1-AI-55277)
10.6 Agreement, dated October 1, 1995, between Ajinomoto Co., Inc. and the Company A**
10.7 Lease Agreement, dated June 30, 1992, for Rockville, Maryland Facility between A**
Cambridge Biotech Corporation and the Company
10.8 Lease Agreement, dated July 28, 1995, for New Britain, Connecticut Facility A**
between MB Associates and the Company
10.9 Worcester County Institution for Savings Warrant dated December 1, 1995 (No. 1) A**
10.10 Worcester County Institution for Savings Warrant dated July 26, 1993 (No. 2) A**
10.11 Stock Purchase Agreement, dated June 5, 1990, between G&G Diagnostics Limited A**
Partnership I and the Company, as amended
10.12 Purchase and Sale Agreement, dated December 11, 1995, for 375 West Street A**
Property between James Leonard, Trustee, C.W.B. Trust and the Company
10.13 Purchase and Sale Agreement, dated December 20, 1995, for 80 Manley Street A**
Property between the Company and Donald M. Leonard, Trustee, Live Oak Realty
Trust
10.14 Stock Purchase Agreement, dated April 26, 1996, between Kyowa Medex Co., Ltd. A**
and the Company
10.15 1987 Non-Qualified Stock Option Plan* A**
10.16 Employee Stock Option Plan* A**
11
10.17 Underwriters Warrants, each dated November 4, 1996, between
the Company and each of Oscar Grus & Son Incorporated and
Kaufman Bros., L.P. B**
10.20 Purchase Agreement, dated October 7, 1996, between BioSeq, Inc. and the Company A**
10.21 Warrant Agreement, dated October 7, 1996, between BioSeq, Inc. and the Company A**
10.22 Stockholders' Agreement, dated October 7, 1996, between BioSeq, Inc. and the A**
Company
10.23 License Agreement, dated October 7, 1996, between BioSeq, Inc. and the Company A**
10.24.1 Commercial Loan Agreement, as of dated March 28, 1997, between The First C**
National Bank of Boston and the Company
10.25 Asset Purchase Agreement, dated March 26, 1997 between Source Scientific, Inc. C**
and the Company
10.26 Contract, dated March 1, 1997, between National Cancer Institute and the Company Filed herewith
11 Statement re: Computation of Per Share Earnings Filed herewith
21.1 Subsidiaries of the Company C**
27 Financial Data Schedule Filed herewith
</TABLE>
- ------------------------
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 Registration Statement, where the
Exhibit was filed as Exhibit No. 10.17 and contained in Exhibit 1.1.
C Incorporated by reference to the Company's Form 10K filed March 31, 1997
* Management contract or compensatory plan or arrangement.
** 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.
12
EXHIBIT 10.26
<TABLE>
<CAPTION>
FILE COPY OMB NO. 0990-0115
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AWARD/CONTRACT 1. THIS CONTRACT IS A RATED ORDER RATING PAGE OF PAGES
UNDER DPAS (15 CFR 350) 1 25
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2. CONTRACT (Proc. Inst Ident.)NO. 3. EFFECTIVE DATE 4. REQUISITION PURCHASE
N02-CP-71001 03/01/97 REQUEST/PROJECT NO.
- --------------------------------------------------------------------------------
5.1SSUED BY CODE 26191001 6.ADMINISTERED BY(If other than item 5) CODE
NATIONAL CANCER INSTITUTE GENETIC EPIDEMIOLOGY BRANCH
RESEARCH CONTRACTS BRANCH, CECS EPIDEMIOLOGY AND BIOSTATISTICS PROGRAM
EXECUTIVE PLAZA SOUTH, ROOM 620 DIVISION OF EPIDEMIOLOGY AND GENETICS
9000 ROCKVILLE PIKE MSC 7224 (RFP NO. NCICP61001-09)
BETHESDA MARYLAND 20892-7224
- --------------------------------------------------------------------------------
7.NAME AND ADDRESS OF THE CONTRACTOR 8. DELIVERY
(No., street, city, county, State [ ]FOB OTHER [X]FOB DESTINATION
and ZIP Code)
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BTRL CONTRACTS & SER., INC. 9. DISCOUNT FOR PROMPT PAYMENT
DBA/BIOTECH RES. LAB.
3 TAFT COURT
ROCKVILLE, MARYLAND 20850 --------------------------------------------
10. SUBMIT INVOICES ITEM
(4 copies unless otherwise SEE SECTION G
PLACE OF PERFORMANCE: specified) ARTICLE G 3.
ROCKVILLE, MARYLAND TO THE ADDRESS SHOWN IN
- --------------------------------------------------------------------------------
CODE FACILITY CODE
- --------------------------------------------------------------------------------
11.SHIP TO/MARK FOR CODE: 12.PAYMENT WILL BE MADE BY CODE
SEE SECTION C, ARTICLE C.2. SEE SECTION G, ARTICLE G3.
- --------------------------------------------------------------------------------
13.AUTHORITY FOR USING OTHER THAN FULL 14.ACCOUNTING AND APPROPRIATION DATA
AND OPEN COMPETITION
CAN1 78428001 TIN 1043152484A1
[ ]10 U.S.C. 2304(c) ( ) ---------- --------------
[ ]41 U.S.C. 253(c) ( ) CAN2 DOC NO. N2CP71001A
---------- --------------
OC CODE 25.2E LOC
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- --------------------------------------------------------------------------------
<S> <C> <C> <C> <C> <C>
15A.ITEM NO. 15B.SUPPLIES/SERVICES 15C.QUANTITY 15D.UNIT 15E.UNIT PRICE 15F.AMOUNT
- --------------------------------------------------------------------------------
TITLE: LABORATORY SUPPORT FOR PROCESSING AND STORAGE CAN1: $ 915,803
OF BIOLOGICAL SPECIMENS FROM PERSONS AT HIGH RISK FROM CANCER CAN2:
----------
CURRENT OBLIGATION: $ 915,803
CONTRACT PERIOD: 03/01/97 THROUGH 02/28/98
CONTRACT TYPE: COST-PLUS FIXED FEE, TERM
- --------------------------------------------------------------------------------------------
15G. TOTAL AMOUNT OF CONTRACT $ 915,803
- --------------------------------------------------------------------------------------------
16. TABLE OF CONTENTS
- --------------------------------------------------------------------------------
(X) SEC. DESCRIPTION PAGE(S)(X) SEC. DESCRIPTION PAGE(S)
PART I - THE SCHEDULE PART II - CONTRACT CLAUSES
- --------------------------------------------------------------------------------
X A SOLICITATION/CONTRACT FORM 1 X I CONTRACT CLAUSES 17
X B SUPPLIES OF SERVICES AND PRICES/COSTS 4 PART III- LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH
X C DESCRIPTION/SPECS-/WORK STATEMENT 6 X J LIST OF ATTACH 24
X D PACKAGIN6 AND MARKING 9 PART IV - REPRESENTATIONS AND INSTRUCTIONS
X E INSPECTION AND ACCEPTANCE 9 K REPRESENTATIONS, CERTIFICATIONS AND
X F DELIVERIES OR PERFORMANCE 10 OTHER STATEMENTS OF OFFERORS
X G CONTRACT ADMINISTRATION DATA ll [] L INSTRS., CONDS., AND NOTICES TO OFFERORS
X H SPECIAL CONTRACT REQUIREMENTS 14 [] M EVALUATION FACTORS FOR AWARD
- ---------------------------------------------------------------------------------------------------------
CONTRACTING OFFICER WILL COMPLETE ITEM 17 OR 18 AS APPLICABLE
- ---------------------------------------------------------------------------------------------------------
17. [X] CONTRACTORS NEGOTIATED AGREEMENT 18 [ ] AWARD(Contract is not required to sign this
(Contractor is required to sign this document and document.) Your offer on Solicitation
return 1 copies to issuing office.) Contractor Number_______________________ including the
agrees to furnish and deliver all items or perform additions or changes made by you which addititons
all the services set forth or otherwise identified or changes are set forth in full above, is herein
above and on any continuation sheets for the accepted as to the items listed above and on any
consideration stated herein. The rights and continuation sheets. This award consummates the
obligations of tbe parties to this contract shall contract which consists of the following
be subject to and governed by the following documents: (a) the Government's solicitation and
documents: (a) this award/contract, (b) the your offer and (b) this award/contract. No further
solicitation, if any, and (c) such provisions, contractual document is necessary.
representation certifications, and specifications,
as are attached or incorporated by reference
herein. (Attachments are listed herein.)
- ---------------------------------------------------------------------------------------------------------
19A. NAME AND TITLE OF SIGNER (Type or print) 20A. NAME OF CONTRACTING OFFICER
Mark Manak, Ph.D., Senior Vice President MARY E. LANDI O'LEARY
- ---------------------------------------------------------------------------------------------------------
19B. NAME OF CONTRACTOR 19C. DATE SIGNED 20B. UNITED STATES OF AMERICA 20C. DATE SIGNED
/s/ Mark Manak Feb 4, 1997 /s/ Mary E. Landi O'Leary 2/12/97
------------------- -------------------------
(Signature of person (Signature of Contracting
authorized to sign) Officer)
- ---------------------------------------------------------------------------------------------------------
</TABLE>
Contract No. N02-CP-71001
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 5
ARTICLE B.4. ADVANCE UNDERSTANDINGS 6
SECTION C-DESCRIPTION/SPECIFICATIONS/WORK STATEMENT 6
ARTICLE C.1. STATEMENT OF WORK 6
ARTICLE C.2. REPORTING REQUIREMENTS 6
SECTION D-PACKAGING, MARKETING AND SHIPPING 9
ARTICLE D.1. PACKAGING 9
ARTICLE D.2. MARKING 9
ARTICLE D.3. SHIPPING 9
SECTION E.-INSPECTION AND ACCEPTANCE 9
ARTICLE E.1. INSPECTION AND ACCEPTANCE 9
SECTION F-DELIVERIES OR PERFORMANCE 10
ARTICLE F.1. PERIOD OF PERFORMANCE 10
ARTICLE F.2. LEVEL OF EFFORT 10
ARTICLE F.3. STOP WORK ORDER 10
SECTION G-CONTRACT ADMINISTRATION DATA 11
ARTICLE G.1. PROJECT OFFICER 11
ARTICLE G.2. KEY PERSONNEL 11
ARTICLE G.3. INVOICE SUBMISSION 11
ARTICLE G.4. CONTRACT FINANCIAL REPORT 12
ARTICLE G.5. INDIRECT COST RATES 13
ARTICLE G.6. GOVERNMENT PROPERTY 14
SECTION H-SPECIAL CONTRACT REQUIREMENTS 14
ARTICLE H.1. REIMBURSEMENT OF COSTS FOR INDEPENDENT RESEARCH
AND DEVELOPMENT PROJECTS 14
ARTICLE H.2. HUMAN SUBJECTS 15
ARTICLE H.3. HUMAN MATERIALS 15
ARTICLE H.4. PRIVACY ACT 15
ARTICLE H.5. OPTION PROVISION 15
ARTICLE H.6. CONFIDENTIALITY OF INFORMATION 16
ARTICLE H.7. PUBLICATION AND PUBLICITY 16
2
Contract No. NO2-CP-71001
PART II - CONTRACT CLAUSES 17
SECTION I - CONTRACT CLAUSES 17
ARTICLE I.1. GENERAL CLAUSES FOR A COST-REIMBURSEMENT
SERVICE CONTRACT 17
ARTICLE I.2. AUTHORIZED SUBSTITUTIONS OF CLAUSES 21
ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES 21
ARTICLE I.4. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN
FULL TEXT 22
PART III 24
SECTION J - LIST OF ATTACHMENTS 24
Statement of Work #1
Invoice/Financing Request Instructions for NIH
Cost-Reimbursement Type Contracts #2
Financial Report of Individual Project/Contract, NIH 2706 #3
Instructions for Completing form NIH 2706 #4
Contractor-Acquired Government Property - Schedule I-B #5
Government Furnished Property - Schedule II-A #6
Privacy Act System of Records #7
Safety and Health #8
Procurement of Certain Equipment #9
PART IV 25
SECTION K - REPRESENTATIONS AND CERTIFICATIONS 25
Representations and Certifications 25
3
Contract No. NO2-CP-71001
SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS
ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES
The Contractor shall maintain a repository of biologic specimens for the
Epidemiology and Biostatistics Program (EBP). This shall include frozen serum,
plasma, urine, tumor tissue, tumor tissue extracts, whole blood cells, separated
and frozen white blood cells, or fractions of white blood cell populations, bone
marrow cells, body fluids, lymphoblastoid cell lines, DNA, stool specimens or
smears on slides and other types of specimens as specifies by the project
Officer. These materials shall be maintained at optimum temperatures for
long-term storage, including liquid nitrogen, if appropriate.
ARTICLE B.2. ESTIMATED COST AMD FIXED FEE
a. The estimated cost of this contract is $868,060.
b. If the Government exercises its option pursuant to ARTICLE H.5. of this
contract the estimated cost of this contract will be increased as follows:
ESTIMATED COST
Option I, Year 2 - $ 900,000
Option II, year 3 - $ 908,670
Option III, Year 4 - $ 968,730
Option IV, Year 5 - $ 978,507
c. The fixed fee for this contract is $47,743. The fee shall be paid in direct
ratio to the level of effort expended; that is, the percent of fee paid
shall be equal to the percent of total effort expended. Payment shall be
subject to the withholding provisions of the clauses ALLOWABLE COST AND
PAYMENT and FIXED FEE referenced in 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.
d. If the Government exercises it's options pursuant to ARTICLE H.5. of this
contract, the fixed fee of this contract will be increased as follows:
FIXED FEE
Option I, Year 2 - $49,500
Option II, Year 3 - $49,977
Option III, Year 4 - $53,280
Option IV, Year 5 - $53,818
e. The Government's obligation, represented by the sum of the estimated cost
plus the fixed fee, is $915,803.
f. If the Government exercises it's options pursuant to Article H.5. of this
contract, the Government's obligation represented by the sum of the
estimated cost plus the fixed fee will be as follows:
COST FEE TOTAL CPFF
Option I, Year 2 $900,000 $49,500 $ 949,500
Optioh II, Year 3 $908,670 $49,977 $ 958,647
Option III, year 4 $968,730 $53,280 $1,022,010
Option IV, year 5 $978,507 $53,818 $1,032,325
4
Contract No. NO2-CP-71001
g. Total funds currency available for payment and allotted to this contract are
$915,803, of which $868,060 represents the estimated costs, and of which
$47,743 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.
h. It is estimated that the amount currently allotted will cover performance of
the contract through February 28, 1998.
i. The Contracting Officer may allot additional funds to the contract without
the concurrence of the Contractor.
ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS
a. Items Unallowable Unless Otherwise Provided
Notwithstanding the clauses, ALLOWABLE COST AND PAYMENT, and FIXED FEE,
incorporated in this contract, 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) Specia1 rearrangement or alteration of facilities;
(3) Purchase or lease of any item of general purpose office furniture or
office equipment regardless of dollar value. (General purpose equipment is
defined as any items of personal property which are usable for purposes
other than research, such as office equipment and furnishings, pocket
calculators, etc.);
(4) Travel to attend general scientific meetings;
(5) Foreign travel - See paragraph b.2., below;
(6) Paient 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.
b. Travel Costs
(1) Domestic Travel
(a) No expenditures for domestic travel (transportation, lodging,
subsistence, and incidental expenses) are to be incurred in direct
performance of this contract without the prior written approval of the
Contracting Officer. In the event travel costs may be required as a
direct cost to this contract, these costs must be approved in writing,
in advance, by the Contracting Officer, and must be certified that the
cost will not be included in the indirect costs.
(b) This contract is subject to the provisions of Section 24 of Public Law
99-234 which amends the Office of Federal Procurement Policy Act to
provide that contractor costs for travel, including lodging, other
subsistence, and incidental expenses, shall be allowable only to the
extent that they do not exceed the amount allowed for Federal
employees.
5
Contract No. NO2-CP-71001
(2) Foreion 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.
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
In no event shall the billing rate or the final amount reimbursable for Overhead
expenses exceed a ceiling of 115% of total direct labor. The Contractor shall
complete all work in accordance with the Statement of Work, terms and conditions
of this contract. Any costs over and above this cost ceiling shall not be
reimbursed under this contract or by any other Government contract, grant, or
cooperative agreement.
SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT
ARTICLE C.1. STATEMENT OF WORK
a. Independently and not as an agent of the Government, the Contractor shall
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 #1, dated
2/97, attached hereto and made a part of this contract.
ARTICLE C.2. REPORTING REQUIREMENTS
In addidon to those reports required by the other terms of this contract, the
Contractor shall prepare and submit the following reports during the period of
performance of this contract:
a. TECHNICAL REPORTS
1. Quarterly Computerized and Written Reports
The Contractor shall submit Ouarterly Computerized and Written Reports
summarizing the status of all newly received specimens and outlining all
dispersals by the laboratory. A summary of all correspondence consisting
of requests for shipment, cover letters and inquiries from outside
collaborators shall be submitted quarterly to the NCI Project Officer and
made available upon request. Emphasis shall be on conciseness as well as
comprehensiveness.
The first quarterly report shall cover the period consisting of the first
full calendar month following the effective date of the contract and shall
be due on or before the 15th day after the end of the reporting period.
Thereafter, quarterly reports shall be due on before the 15th day of the
month following each reporting period. The submission of quarterly reports
shall continue through the exercise of each option period. A Ouarterly
Computerized and Written Report shall not be required when submitting the
Annual Reports or Final Report.
6
Contract No. NO2-CP-71001
2. Final Technical Progress Report
The Contractor shall submit a final technical progress report on or before
the expiration date of the contract. The Final Report shall include
information in sufficient detail to describe comprehensively the results
achieved and shall include a summation (not to exceed 200 words) of the
work performed for the entire contract period of performance.
IF OPTIONS EXERCISED
3. Annua1 Technica1 Progress Reports
The Contractor shall prepare Annual Technical Progress Reports which
explain the progress of work performed under this contract. Each report
shall describe the progress of the project to date, noting all technical
areas in which effort is being directed and indicating the status of work
in each area. This report shall include:
a) a quantitative summary of the number of specimens processed by the
Contractor, their type and investigator source;
b) shipments and logistics;
c) an indication of current problems that may impede performance under the
contract and proposed corrective actdon; and
d) a discussion of work to be performed during the next reporting period.
The annual report shall, in addition, include an up-to date inventory of the
Repository and its contents. Additional interim reports may be requested as
necessary.
The first annual report shall cover the period consisting of the first full 12
calendar months of performance and any fractional part of the initial month and
shall be due on or before the 15th day after the end of the reporting period.
Thereafter, reports shall be due on or before the 15th day following each
reporting period. An annual report shall not be required when a final report is
due.
B. REPORT SUBMISSION
1. Copies of the reports shall be submitted in the following manner:
Reports Period Covered Due Date Ouantities
------- -------------- -------- ---------
03/01/97 - 05/31/97 06/15/97
Quarterly 06/01/97 - 08/31/97 09/15/97 Original +
09/01/97 - 11/30/97 12/15/97 3 copies
NOTE: IF THE GOVERNMENT EXERCISES ITS OPTIONS PURSUANT TO ARTICLE H., OPTION
PROVISION, THE QUARTERLY PROGRESS REPORT WILL CONTINUE TO BE DELIVERED IN
THE FOLLOWING MANNER:
7
Contract No. NO2-CP-71001
Reports Period Covered Due Date Quantities
03/01/98 - 05/31/98 06/15/98
06/01/98 - 08/31/98 09/15/98
09/01/98 - 11/30/98 12/15/98
03/01/99 - 05/31i99 06/15/99 Original +
Quarterly 06/01/99 - 08/31/99 09/15/99 3 copies
09/01/99 - 11/30/99 12/15/99
03/01/00 - 05/31/00 06/15/00
06/01/00 - 08/31/00 09/15/00
09/01/00 - 11/30/00 12/15/00
03/01/01 - 05/31/01 06/15/01
06/01/01 - 08/31/01 09/15/01
09/01/01 - 11/30/01 12/15/01
03/01/02 - 05/31/02 06/15/02
06/01/02 - 08/31/02 09/15/02
09/01/02 - 11/30/02 12/15/02
NOTE: IF THE GOVERNMENT EXERCISES ITS OPTIONS PURSUANT TO ARTICLE H., OPTION
PROVISION, THE ANNUAL PROGRESS REPORT WILL BE DELIVERED IN THE FOLLOWING
MANNER:
03/01/97 - 02/28/98 03/15/98
03/01/98 - 02/28/99 03/15/99 Original +
Annual 03/01/99 - 02/28/00 03/15/00 3 Copies
03/01/00 - 02/28/01 03/15/01
Final Life of contract Expiration date Original +
Of Contract 3 copies
2. THE ABOVE ITEMS SHALL BE ADDRESSES AND DELIVERED TO:
Addressee No. Of copies
Mary E. Landi O'Leary
Contracting Officer
Research Contracts Branch Original +
National Cancer Institute, EPS/620 1 copy
6120 EXECUTIVE BLVD MSC 7224
Bethesda, MD 20892-7224
Dr. Niel Caporaso, Project Officer
Genetic Epidemiology branch
Epidemiology & Biostatistics program
Division of Cancer Etiology 2 Copies
Executive Plaza North, Room 439
6130 EXECUTIVE BLVD 7372
BETHESDA MD 20892-7372
8
Contract No. NO2-CP-71001
SECTION D - PACKAGING, MARKETING AND SHIPPING
ARTICLE D. 1. PACKAGING
Specimens shall be protected from temperature extremes by use of insulated
containers or other acceptable means as needed. A portable liquid nitrogen
container for transport of frozen cells shall also be required.
ARTICLE D.2. MARKING
All deliverables under this contract shall be clearly identified with the
subject contract number. All specimens shall be submitted to the Contractor,
accompanied by written identification of the specimen source, using forms
supplied by the Project Officer. All specimens from members of the
NCI-associated families will be submitted with a unique alpha-numeric code
number which will be the only identification of the specimen in future
laboratory processing, dispersal, etc. The name of the donor shall not be used
in the labeling of specimens by laboratory personnel. NO NAMES OF PERSONS
ENROLLED IN AIDS ASSOCIATED STUDIES SHALL BE WRITTEN ON VIALS.
ARTICLE D.3. SHIPPING
The Contractor shall prepare specimens for shipment, supply shipping containers
appropriate to maintain specimens in the proper state (cool, frozen, deep
frozen, etc.) and make arrangements through commercia1 air freight companies and
other carriers to send biologic specimens to collaborating investigators in an
expeditious (e.g., overnight or same day) fashion. For immunologic or genetic
typing studies, the Contractor shall prepare specimens for delivery to the local
Human Leutocyte Antigen (HLA) typing laboratory or immune function laboratory in
a suitable form. The local in-house delivery service shall be used for these
particular specimens to ensure expeditious delivery under optimum conditions. In
some cases, commercial freight companies shall be used for overnight shipments
to investigators in other cities. The Contractor shall be responsible for
notifying the receiving laboratory of the specimens shipment and anticipated
arrival time to insure that the receiving laboratory is prepared to receive the
specimens.
SECTION E - lNSPECTION AND ACCEPTANCE
ARTICLE E. 1 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: The National Cancer
Institute, Division of Cancer Epidemiology and Genetics, Genetic
Epidemiology Branch, Epidemiology & Biostatistics Program, 6130 Execubve
Boulevard, Executive Plaza North, Room 439, Rockville, MD 20852. Acceptance
may be presumed unless otherwise indicated in writing by the Contracting
Officer or the duly authorized representative within 30 days of receipt.
d. This contract incorporates the following clause by reference, with the same
force and effect as if it were given in full text. Upon request, the
Contracting Officer will make its full text available.
FAR Clause 52.246-5, INSPECTION OF SERVICES COST REIMBURSEMENT(APRIL 1984).
9
Contract No. NO2-CP-71001
SECTION F - DELIVERIES OR PERFORMANCE
ARTICLE F.1. PERIOD OF PERFORMANCE
The period of performance of this contract shall be from March 1, 1997 through
February 28, 1998. If the Government exercises its options pursuant to ARTICLE
H.5., of this contract the period of performance of this contract will be:
Option Period of Performance
Option I - Year 2 - March 1, 1998 through February 28, 1999
Option II - Year 3 - March 1, 1999 through February 28, 2000
Option III - Year 4 - March 1, 2200 through February 28, 2001
Option IV - Year 5 - March 1, 2001 through February 28, 2002
ARTICLE F.2. LEVEL OF EFFORT
a. During the period of performance of this contract, the Contractor shall
provide 18,620 direct labor hours each year totaling 93,100 if all options
are exercised. The labor hours exclude vacation, sick leave, and holiday.
It is estimated that the labor hours are constituted as specified below and
will be expended approximately as follows:
Labor Hours
Base Option I Option II Option III Option IV
Labor Category Year 1 Year 2 Year 3 Year 4 Year 5
- -------------- ------ ------ ------ ----- ------
Principal Investigator 1,120 1,120 1,120 1,120 1,120
Professional 7,488 7,488 7,488 7,488 7,488
Lab Technicians 3,744 3,744 3,744 3,744 3,744
AdminlData Entry 4,864 4,864 4,864 4,864 4,864
Driver 1,404 1,404 1,404 1,404 1,404
Totals 18,620 18,620 18,620 18,620 18,620
b. The Contractor shall have satisfied the reguirement herein if not less than
95% nor more than 105% of the total direct labor hours, specified herein
are furnished.
c. In the event fewer hours than the minimum specified number of direct labor
hours in the total categories are used by the Contractor in accomplishing
the prescribed work and the Government has not invoked its rights under the
FAR Clause 52.249, TERMINATION (Cost-Reimbursement), incorporated in this
contract, these parties agree that the fee will be adjusted based solely
upon the guantity of hours by which the number of direct labor hours
furnished is less than the number of direct labor hours specified in this
ARTICLE. The resulting adjustment shall be evidenced by a contract
modification.
ARTICLE F.3. STOP WORK ORDER
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.
FEDERAL ACQUISITION REGULATION (48 CFR CHAFTER 1) CLAUSE:
52.242-15, STOP WORK ORDER (AUGUST 1989) with ALTERNATE I (APRIL 1984).
10
- --------------------------------------------------------------------------------
Contract No. NO2-CP-71001
SECTION G - CONTRACT ADMINISTRATION DATA
ARTICLE G.1. PROJECT OFFICER
The following Project Officer will represent the Government for the purpose of
this contract:
Dr. Neil Caporaso
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 individuals are considered to be essential to the work being performed
hereunder:
NAME TITLE
Mark Cosentino Principal Investigator
Kathi Shea Lab Manager
ARTICLE G.3. INVOICE SUBMISSION
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.
Invoices/financing requests shall be submitted concurrently as follows:
(1) An original and two copies to the following designated payment office:
National Institutes of Health
Office of Financial Management
Contracts Section, FAAB
Building 31, Room BlB05
31 CENTER DR MSC 2050
BETHESDA MD 20892-2050
11
Contract No. NO2-CP-71001
(2) FOUR copies to the following approving officer:
Mary E. Landi O'LEARY
Contracting Officer
Research Contracts Branch
National Cancer Institute, NIH
EPS, Room 620
6120 EXECUTIVE BLVD MSC 7224
BETHESDA MD 20892-7224
Inquiries regarding payment of invoices should be directed to the
designated payment office, attention of Chief, Contract Accounting Section,
DEFS (301) 496-6452.
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 45th
day after the close of the reporting period. The line entries for
subdivisions of work end elements of cost (expenditure categories) which
shall be reported within the total contract are listed in paragraphe;
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 following is a listing of expenditure categories to be reported:
Expenditure Category
A
--------------------
(1) Direct Labor
(a) Principal Investigator
(b) Key Personnel
(2) Other Personnel
(3) Overhead
(4) Materials/Supplies
(5) ODC's (ODC's must be itemized)
(6) Equipment (Equipment must be itemized)
(7) G&A Expense
(8) Total Cost
(9) Fixed Fee
(10) Total Cost Plus Fixed Fee
12
Contract No. NO2-CP-71001
f. Copies of the above report shall be submitted in the following manner:
REPORTS PERIOD COVERED DUE DATE QUANTITIES
Contract 03/01/97 - 05/31/97 07/15/97
Financial 06/01/97 - 08/31/97 10/15/97 Original +
Reports 09/01/97 - 11/30/97 01/15/98 2 copies
NOTE: IF THE GOVERNMENT EXERCISES ITS OPTIONS PURSUANT TO ARTICLE H., OPTION
PROVISION, THE CONTRACT FINANCIAL REPORTS (NIH-2706) WILL CONTINUE TO BE
DELIVERED IN THE FOLLOWING MANNER:
12/01/97 - 02/28/98 04/15/98
03/01/98 - 05/31/98 07/15/98
06/01/98 - 08/31/98 10/15/98
09/01/98 - 11/30/98 01/15/99
12/01/98 - 02/28/99 04/15/99
03/01/99 - 05/31/99 07/15/99 Original +
Contract 06/01/99 - 08/31/99 10/15/99 2 copies
Financial 09/01/99 - 11/30/99 01/15/00
Report 12/01/99 - 02/28/00 04/15/00
03/01/00 - 05/31/00 07/15/00
06/01/00 - 08/31/00 10/15/00
09/01/00 - 11/30/00 01/15/01
12/01/00 - 02/28/01 04/15/01
03/01/01 - 05/31/01 07/15/01
06/01/01 - 08/31/01 10/15/01
09/01/01 - 11/30/01 01/15/02
12/01/01 - 02/28/02 02/28/02
g. The above item shall be addresses and delivered to:
Contracting Officer
N02-CP-71001
Cancer Epidemiology Contracts Section
Research Contracts Branch
Nadonal Cancer Institute, NIH
6120 EXECUTIVE BLVD MSC 7224
BETHESDA MD 20892-7224
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 1, the cognizant Contracting Officer
responsible for negotiating provisional and/or final indirect cost rates is
identified as follows:
Chief, Financial Advisory Services Branch
Division of Contracts and Grants
National Institutes of Health
6100 EXECUTIVE BLVD ROOM 6B05
BETHESDA MD 20892
These rates are hereby incorporated without further action of the Contracting
Officer.
13
Contract No. NO2-CP-71001
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
Administrator.
This contract's Contract Property Administrator is:
David A. Hubbard, II
Contracts Property Administrator
Research Contracts Property Administration, NIH
Building 13, Room 2E-65
13 SOUTH DR MSC 5748
BETHESDA MD 20892-5748
(301) 496-6467
b. Contractor-Acquired Government Property - Schedule I-B
Pursuant to the clause, GOVERNMENT PROPERTY, incorporated in this
contract, the Contractor will be authorized to acquire the property listed
in Schedule I-B, Attachment #5, 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. Government Furnished Property - Schedule II-A
Pursuant to the clause, GOVERNMENT PROPERTY, incorporated in this
contract, the Contractor is hereby authorized to retain custody of the
property listed in Schedule II-A, Attachment #6 for use in direct
performance of this contract. Accountability for the items listed in
Schedule II-A is hereby transferred to this contract from predecessor
Contract No. N01-CP-33060, under which these items were provided by the
Government. Title to this property shall remain in the Government.
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 devdopment 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.
14
Contract No. NO2-CP-71001
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
Contract or 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. PRIVACY ACT
This procurement action requires the Contractor to do one or more of the
following: design, develop, or operate a system of records on individuals to
accomplish an agency function in accordance with the Privacy Act of 1974, Public
Law 93-579, December 31, 1974 (5 USC 552a) and applicable agency regulations.
Violation of the Act may involve the imposition of criminal penalties.
The Privacy Act System of Records applicable to this project is Number
09-25-0130. This document is incorporated into this contract as Attachment #6.
ARTICLE H.5. OPTION PROVISION
Unless the Government exercises its option pursuant to the Option Clause set
forth in ARTICLE I.3., the contract will consist only of the entire Statement of
Work for 12 months only as defined in Sections C and F of the contract. Pursuant
to clause 52.217-9 set forth in ARTICLE I.3. of this contract, the Government
may, by unilateral contract modification, require the Contractor to perform the
Statement of Work for an additional 48 months (12 months per each option) as
also defined in Sections C and F of the contract. If the Government exercises
this option, notice must be given at least 60 days prior to the expiration date
of this contract, and the estimated cost plus fixed fee of the contract will be
increased as set forth in ARTICLE B.2.
15
Contract No. NO2-CP-71001
ARTICLE H.6. CONFIDENTIALITY OF INFORMATTON
The following information is covered by HHSAR Chase 352.224-70, Confidendality
of Information (APRIL 1984):
a. Identification of Specimen source or donor name;
b. All records of manipulations on all specimens;
c. Information concerning the identification of the patient, the diagnosis,
demographic information or other such information;
d. Written, hard-copy records of inventory sheets.
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 acknowledgement substantially as follows:
"This project has been funded in whole or in part with federal funds from the
National Cancer Institute, National Institutes of Health, under Contract
No.N02-CP-71001."
16
Contract No. NO2-CP-71001
PART II - CONTRACT CLAUSES
PART II
SECTION I - CONTRACT CLAUSES
ARTICLE I.1. GENERAL CLAUSES FOR A COST-REIMBURSEMENT SERVICE CONTRACT - CLAUSES
INCORPORATED BY REFERENCE (APRIL 1984)
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 [FAR 52.252-2 (JUNE
1988)].
a. FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES:
FAR
CLAUSE NO. TITLE AND DATE
52.202-1 Definitions (OCTOBER l995)
52.203-3 Gratuides (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)
52.203-10 Price or Fee Adjustment for Illegal or Improper
Activity (Over $100,000) (SEPTEMBER l990)
52.203-12 Limitation on Payments to Influence Certain Federal
Transactions (Over $100,000) (JANUARY 1990)
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 (JULY 1995)
52.215-2 Audit and Records - Negotiation (Over $100,000)
(AUGUST 1996)
52.215-22 Price Reduction for Defective Cost or Pricing Data
(OCTOBER 1995)
52.215-24 Subcontractor Cost or Pricing Data (Over $500,000)
(OCTOBER 1995)
52.215-26 Integrity of Unit Prices (Over $100,000) (OCTOBER
1995)
52.215-27 Termination of Defined Benefit Pension Plans (MARCH
1996)
52.215-33 Order of Precedence (JANUARY 1986)
17
Contract No. NO2-CP-71001
FAR
CLAUSE NO. TITLE AND DATE
---------- --------------
52.215-39 Reversion or Adjustment of Plans for Post-Retirement
Benefits other than Pensions (PRB) (MARCH 1996)
52.215-40 Notification of Ownership Changes (Over $500,000)
(FEBRUARY 1995)
52.215-42 Requirements for Cost or Pricing Data or Information
Other Than Cost or Pricing Data-- Modifications
(OCTOBER 1995)
52.216-7 Allowable Cost and Payment (AUGUST 1996)
52.216-8 Fixed Fee (APRIL 1984)
52.219-8 Utilization of Small, Small Disadvantaged, and
Women-Owned Small Business Concerns (Over $100,000)
(OCTOBER 1995)
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 EEO Preaward Clearance of Subcontracts (Over
$1,000,000) (APRIL 1984)
52.222-35 Affirmative Action for Special Disabled and Vietnam
Era Veterans (APRIL 1984)
52.222-36 Affirmative Action for Handicapped Workers (APRIL
1984)
52.222-37 Employment Reports on Special Disabled Veterans and
Veterans of the Vietnam Era JANUARY 1988)
52.223-2 Clean Air and Water (Over $100,000) (APRIL 1984)
52.223-6 Drug Free Workplace(JULY 1990)
52.223-14 Toxic Chemical Release Reporting (OCTOBER 1996)
52.225-1l Restrictions on Certain Foreign Purchases (OCTOBER
1996)
52.227-1 Authorization and Consent (Over $50,000) (JULY 1995)
52.227-2 Notice and Assistance Regarding Patent and Copyright
Infringement (Over $100,000) (AUGUST 1996)
18 CR-Service 10/96
Contract No. NO2-CP-71001
FAR
CLAUSE NO. TITLE AND DATE
---------- --------------
52.227-3 Patent Indemnity (APRIL 1984)
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 (MARCH l994)
52.232-33 Mandatory Information for Electronic Funds Transfer
Payment (AUGUST 1996)
52.233-1 Disputes (OCTOBER l995)
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 l995)
52.242-4 Certification of Indirect Costs (OCTOBER 1995)
52.242-13 Bankruptcy (Over $100,000) (JULY 1995)
52.243-2 Changes - Cost Reimbursement (AUGUST 1987) Alternate
I (APRIL 1984)
52.244-2 Subcontracts (Cost-Reimbursement and Letter
Contracts) (MARCH l996) *If written consent to
subcontract is required, the identified subcontracts
are listed in ARTICLE B, Advance Understandings of
the contract.
52.244-5 Competition in Subcontracting (Over $100,00)(JANUARY
l996)
52.245-5 Government Property (Cost-Reimbursement, Time and
Material, or Labor-Hour Contract) (JANUARY 1986)
52.246-25 Limitation of Liability - Services (Over $100,000)
(APRIL 1984)
52.249-6 Termination (Cost-Reimbursement) (SEPTEMBER l996)
52.249-14 Excusable Delays (APRIL 1984)
52.253-1 Computer Generated Forms (JANUARY 199l)
19 CR-Service 10/96
Contract No. NO2-CP-71001
b. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR)(48 CFR
CHAPTER 3) CLAUSES:
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 l99l)
352.270-7 Paperwork Reduction Act (APRIL 1984)
[End of GENERAL CLAUSES FOR A COST-REIMBURSEMENT SERVICE CONTRACT]
20 CR-Service 10/96
Contract No. NO2-CP-71001
ARTICLE 1.2. AUTHORIZED SUBSTITUTIONS OF CLAUSES
ARTICLE 1.1. of this SECTION is hereby modified as follows:
(1) FAR Clause 52.219-9, SMALL, SMALL DISADVANTAGED, AND WOMEN-OWNED SMALL
BUSINESS SUBCONTRACTING PLAN (OCTOBER 1995), and FAR Clause 52.219-16,
LIQUIDATED DAMAGES-- SUBCONTRACTING PLAN (OCTOBER 1995) are deleted in
their entirety.
(2) FAR Clause 52.232-20, LIMITATION OF COST (APRIL 1984), 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.
Where necessary, the Government has indicated required clause information
specific to this contract.
a. FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES:
(1) FAR Clause 52.215-31, Waiver of Facilities Capital Cost of Money
(SEPTEMBER 1987) is added.
(2) FAR 52.217-9, Option to Extend the Term of the Contract (MARCH 1989).
"(a) The Government may extend the term of this contract by written
notice to the Contractor within 60....
(c) The total duration of this contract, including the exercise of any
options under this clause, shall not exceed 60 MONTHS.
(3) FAR 52.219-6, Notice of Small Business Set-Aside JULY 1996).
(4) FAR 52.219-14, Limitations on Subcontracting JANUARY 1991).
(5) FAR 52.224-1, Privacy Act Notification (APRIL 1984).
(6) FAR 52.224-2, Privacy Act (APRIL 1984).
(7) Alternate I (JUNE 1987), FAR 52.227-14, Rights in Data--General JUNE
1987).
(8) FAR 52.251-1, Government Supply Sources (APRIL 1984).
b. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATIONS/PUBLIC
HEALTH SERVICE ACQUISITION ON REGULATIONS (HHSAR)(PHSAR)(48 CFR CHAPTER 3)
CLAUSES: This contract incorporates the following clauses by reference,
(unless otherwise noted) with the same force and effect as if they were
given in full text. Upon request, the Contracting Officer will make their
full text available.
(1) PHS 352.223-70, Safety and Health (APRIL 1984), is hereby incorporated
in full text. See Part III, Section J of this contract.
(2) HHSAR 352.224-70, Confidendality of Information (APRIL 1984).
c. NATIONAL INSTITUTES OF HEALTH (NIH) RESEARCH CONTRACTING (RC) CLAUSES: The
following clause(s) are attached and made a part of this contract:
(1) NIH(RC)-7, Procurement of Certain Equipment (APRIL 1984) (OMB Bulletin
81-16).
21
Contract No. NO2-CP-71001
ARTICLE I.4. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT
This contract incorporates the following clauses in full text.
FEDERAL ACQUISITION REGULATION (FAR)(48 CFR CHAPTER 1) CLAUSES:
a. FAR Clause 52.203-9 REQUIREMENT FOR CERTIFICATE OF PROCUREMENT INTEGRITY--
MODIFICATION (OVER $100.000) (SEPTEMBER 1995)
(a) DEFINITIONS. The definitions set forth in FAR 3.1044 are hereby
incorporated in this clause.
(b) The Contractor agrees that it will execute the certification set
forth in paragraph (c) of this clause when requested by the
Contracting Officer in connection with the execution of any
modification of this contract.
(c) CERTIFICATION. As required in paragraph (b) of this clause, the
officer or employee responsible for the modification proposal shall
execute the following certification. The certification in paragraph
(c)(2) of this clause is not required for a modification which
procures commercial items.
CERTIFICATE OF PROCUREMENT INTEGRITY-MODIFICATION (NOVEMBER 1990)
(1) I, _______________ [NAME OF CERTIFIER] am the officer or employee
responsible for the preparation of this modification proposal and
hereby certify that, to the best of my knowledge and belief, with
the exception of any information described in this certification,
I have no information concerning a violation or possible
violation of subsection 27(a), (b), (d), or (f) of the Office of
Federal Procurement Policy Act, as amended* (41 U.S.C. 423),
(hereinafter referred to as "the Act"), as implemented in the
FAR, occurring during the conduct of this procurement [contract
and modifcation number].
(2) As required by subsection 27(e)(1)(B) of the Act, I further
certify that to the best of my knowledge and belief, each
officer, employee, agent, representative, and consultant of
_______(Name of Offerer) who has participated personally and
substantially in the preparation or submission of this proposal
has certified that he or she is familiar with, and will comply
with, the requirements of subsection 27(a) of the Act, as
implemented in the PAR, and will report immediately to me any
information concerning a violation or possible violation of
subsections 27(a), (b), (d), or (f) of the Act, as implemented in
the FAR, pertaining to this procurement.
(3) VIOLATIONS OR POSSIBLE VIOLATIONS: [CONTINUE ON PLAIN BOND PAPER
IF NECESSARY AND LABEL CERTIFICATE OF PROCUREMENT
INTEGRITY-MODIFICATION (CONTINUATION SHEET), ENTER "NONE" IF NONE
EXISTS]
-----------------------------------------------------------------
-----------------------------------------------------------------
-----------------------------------------------------------------
---------------------
[SIGNATURE OF THE OFFICER OR EMPLOYEE RESPONSIBLE FOR THE
MODIFICATION PROPOSAL AND DATE]
---------------------
[TYPED NAME OF THE OFFICER OR EMPLOYEE RESPONSIBLE FOR THE
MODIFICATION PROPOSAL]
*Subsections 27(a), (b), and (d) are effective on December 1,
1990. Subsection (f) is effective on June 1, 1991.
22
Contract No. N02-CP-71001
THIS CERTIFICATION CONCERNS A MATTER W1THIN THE JURISDICTION OF
AN AGENCY OF THE UNITED STATES AND THE MAKING OF A FALSE,
FICTITIOUS, OR FRAUDULENT CERTIFICATION MAY RENDER THE MAKER
SUBJECT TO PROSECUTION UNDER TITLE 18, UNITED STATES CODE,
SECTION 1001.
[End of certification]
(d) In making the certification in paragraph (2) of the certificate, the
officer or employee of the competing Contractor responsible for the offer
or bid, may rely upon a one-time certification from each individual
required to submit a certification to the competing Contractor,
supplemented by periodic training. These certifications shall be obtained
at the earliest possible date after an individual required to certify
begins employment or association with the Contractor. If a contractor
decides to rely on a certification executed prior to the suspension of
secdon 27 (i.e., prior to December 1, 1989), the Contractor shall ensure
that an individual who has so certified is notified that section 27 has
been reinstated. These certifications shall be maintained by the
Contractor for a period of 6 years from the date a certifying employee's
employment with the company ends or, for an agent, representative, or
consultant, 6 years from the date such individual ceases to act on behalf
of the Contractor.
(e) The certification required by paragraph (c) of this clause is a material
representation of fact upon which reliance will be placed in executing
this modification.
[End of clause]
23
Contract No. NO2-CP-71001
PART III
SECTION J - LIST OF ATTACHMENTS
The following documents are attached and incorporated in this contract:
1. Statement of Work, (02/97), 6 pages.
2. Invoice/Financing Request Instructions for NIH Cost-Reimbursement Type
Contracts, NIH(RC)-1 (6/18/92), 4 pages.
3. Financial Report of Individual Project/Contract, NIH 2706, (5/92), 1 page.
4. Instructions for Completing form NIH 2706, Financial Report of Individual
Project/Contract, (5/92), 3 pages.
5. Contractor-Acquired Government Property - Schedule I-B, (2/97), 1 page.
6. Government Furnished Property - Schedule II-A, (2/97), 2, pages.
7. Privacy Act System of Records, Number 09-25-0130, as cited in the Federal
Register Notice issued in Volume 56, Number 8, 2 pages, dated 1/91
8. Safety and Health, PHSAR Clause 352.223-70,(4/84), 2 pages.
9. Procurement of Certain Equipment, NIH(RC)-7, 4/1/84, 1 page.
24
Contract No. N02-CP-71001
PART IV
-------
SECTION K - REPRESENTATIONS AND CERTIFICATIONS
- ----------------------------------------------
The following documents are incorporated by reference in this contract:
1. Representations and Certifications, dated November 27, 1996.
END of the SCHEDULE
-------------------
(CONTRACT)
25
Contract No. N02-CP-71001
Statement of work
-----------------
a. Independently and not as an agent of the Government, the Contractor
shall be required to furnish all the necessary services, qualified
personnel, material, equipment, and facilities, not otherwise provided
by the Government, as needed to perform the Statement of Work below:
1) The Contractor shall provide the services described below in
accordance with Contractor-developed, Government-approved
protocols:
a) separation and viable cryopreservation of blood
mononuclear Lymphocytes;
b) separation, aliquotting and storage of serum, plasma
and/or urine as needed;
c) cryopreservation of bone marrow samples;
d) storage of tumor extracts;
e) cryopreservation of whole tumor tissue;
f) cryopreservation of intact red blood cells;
g) viable cryopreservation of previously established
lymphoblastoid cell lines;
h) storage of DNA and other biological materials as specified
by the Project Officer (e.g., pathology slides and tissue
block);
i) extraction of DNA from biologic materials;
j) specimen processing as required by NCI to preserve special
biologic materials;
k) logging in, labeling and tracking of each vial of each
sample employing an NCI developed computerized specimen
tracking system, including all laboratory safeguards to
insure the fidelity and purity of each sample; and
1) maintenance of the previously-established repository
currently containing more than 1.4 million biological
specimens and allowance for an estimated increase of up to
25% of freezer storage space.
Statement of Work Attachment #1
02/97 Page 1 of 6
Contract No. N02-CP-71001
2) Processing services shall be available routinely between the
hours of 9:00 a.m. and 2:00 p.m., Monday through Friday, and at
any other time (including nights, weekends and holidays) by
special arrangement, usually with advance notice. A laboratory
staff member shall be available during nonbusiness hours for
emergency specimen processing (as might occur when a patient
dies). A biobazard area adequate for processing specimens with
Acquired Immunodeficiency Syndrome (AIDS) shall be available for
the processing of all biologic samples.
3) The Contractor shall supply messenger service to pick up
specimens or inter-laboratory communication from medical care
facilities in the Washington, D C., area or at area
transportation centers (i.e., Dulles International, D.C. National
and Baltimore/Washington International Airports). This messenger
service shall be supplied by the Contractor and not subcontracted
to commercial carriers. All specimens submitted to the laboratory
for processing shall be scheduled in advance, except in
emergencies as detailed below. Specimens shall be delivered to
the Contractor's laboratory within four hours of notification for
pick-up. Specimens shall be protected from temperature extremes
by use of insulated containers or other acceptable means as
needed. A portable liquid nitrogen container for transport of
frozen cells or tumor specimens shall also be required. Only
specimens provided by or approved by the Project Officer shall be
accepted for processing and storage by the Contractor.
4) The Contractor shall be responsible for recording and monitoring
the location of all specimens that are being sent or received
through use of a log book of all requests and specimens. The
Contractor shall be responsible for monitoring, shipping and
receipt of specimens to minimize delay or loss. If a specimen is
not received within four hours of expected delivery, the
Contractor shall inform the Project Officer by telephone. An
after-hours telephone number of the Contractor's staff member
shall be available to assist in this follow-up and the staff
member shall be available at that number. The Contractor shall be
responsible for immediately tracing the location of delinquent
specimens not received when expected. All specimens that are of
questionable research value shall be noted and the Project
Officer immediately notified by telephone, as well as in writing,
providing identifying names or numbers, quantity, place of
origin, a concise narrative description of the event, etc., so
that appropriate action can be initiated. The Contractor shall
designate a specific individual to be responsible for after-hours
specimen processing and name an alternate to act when the primary
person is not available.
5) The Contractor shall maintain a repository of biologic specimens
for the Epidemiology and Biostatistics Program (EBP). This shall
include frozen serum, plasma, urine, tumor tissue, tumor tissue
extracts, whole red blood cells, separated and frozen white blood
cells, or fractions of white blood cell populations, bone marrow
cells, body fluids, lymphoblastoid cell lines, DNA, stool
specimens or smears or slides, pathology paraffin blocks, and
other types of specimens as specified by the Project Officer.
These materials shall be maintained at optimum temperatures for
long-term storage, including liquid nitrogen, if appropriate.
Statement of Work Attachment #1
02/97 Page 2 of 6
Contract No. N02-CP-71001
6) All specimens will be submitted to the Contractor, accompanied by
written identification of the specimen source, using forms
supplied by the Project Officer. Specimens from members of
NCI-associated families will be submitted with a unique Family
Studies identification number to insure compatibility with NCI
laboratory computer data bases. Specimens shall be assigned a
unique code number which shall be the only identification of the
specimen in future laboratory processing, dispersal, etc. This
code number shall comply with the format and convention
established by the NCI Project Officer. The name of the donor
shall not be used in labeling of specimens or in correspondence
concerning the specimen by laboratory personnel. Such labeling
shall uniquely identify each vial of each specimen and the
quality of that individual vial will be recorded and updated as
needed in the NCI-developed computer system.
7) The Contractor shall provide and train primary and backup staff
in the operation of a computerized record system for specimens
which has been developed and furnished by the Project Officer.
Using this system, the laboratory shall keep records of all
manipulation on all specimens and accurately enter data on each
specimen. The data shall include but not be limited to vial
identification number, study ID, material type and material
description, volume, weight or cell concentration, freezer
location, subject ID, crisis events, data received, specimen vial
quality, etc. Data shall be entered into the system, with
attention to extreme accuracy, within 48 hours of receipt or as
specified by the NCI Project Officer. The Contractor shall be
responsible for extracting this information from either data
forms or floppy disks which will be transmitted with the samples.
The Contractor shall also use this system to monitor and track
all activities related to specimens. The Project Officer will
supply computer support for generating management reports for the
Contractor on a regular basis.
8) The Contractor shall prepare a variety of specimens for storage.
Specifically, white blood cell separation, fractionation and
viable cryopreservation, red blood cell cryopreservation, serum
separation and storage of aliquots of 0.5 ml, plasma separation
and storage, tumor tissue freezing, tumor tissue extracts, urine,
serum, or blood fluid lyophilization, freezing and/or extraction
of stool specimens and other techniques as required. Specimens
shall be stored in containers impervious to entry of CO2 so that
they can be shipped on dry ice. In order to ensure the viability
of valuable specimens, the Contractor shall be prepared to have
appropriate personnel travel to a contract site, foreign or
domestic, to train local staff on optimal techniques for freezing
viable material.
Statement of Work Attachment #1
02/97 Page 3 of 6
Contract No. N02-CP-71001
9) Freezers shall be equipped with a stylus recording system
indicating consistency of temperature which shall be reviewed an
a scheduled basis each day at specified times. Freezer
malfunctions must give warning by means of an alarm system. The
Contractor must provide a central alarm system monitored 24-hours
a day, 365 days a year. A switch-operated electric generator of
appropriate wattage for these particular freezers shall be hooked
up and be maintained on standby in the event of a major power
outage. Liquid nitrogen freezers must have automatic filling
mechanisms drawing on a constant central source of liquid
nitrogen with emergency back-up. All unplanned defrostings must
be logged, giving date and times during which defrostings were in
effect and temperature reached, and reported by telephone as soon
as possible to the Project Officer. The circumstances of the
defrosting shall be reported immediately to the Project Officer
in writing, giving full particulars.
10) The laboratory shall keep clear records of all manipulations on
all specimens and carefully document specimen type, volume, cell
concentration, source, "crisis events", etc. for each sample. The
exact freezer location shall be known for each specimen and shall
be kept in a master log which is easy to understand. Information
shall be supplied routinely to the NCI Project Officer on forms
designed and supplied by NCI in conjunction with laboratory
personnel. Ihese records shall include number of vials, exact
location of vials and specimen type. The Contractor shall conduct
a complete inventory of all stored specimens on an annual basis.
Thorough quality control protocols must be designed, documented
and approved by the NCI Project Officer. These protocols must be
rigorously implemented in the conduct of the inventories. The
results of each inventory shall be documented in the Annual
Technical Progress Report.
11) The Contractor shall respond only to written requests for
biological specimens from collaborating investigators, which have
been approved by the NCI Project Officer or his/her designee(s).
Specimens shall not be sent to any investigator without a written
request from the NCI Project Officer or his/her designee(s). A
copy of this written request and Contractor-generated
correspondence shall be sent to the NCI Project Officer. All
written requests for specimen distribution shall be acted upon
within four working days of receipt, unless permission to delay
such action is obtained from the Project Officer.
The Contractor shall not supply the outside collaborator with any
information concerning the biological specimens other than code
number, specimen type or other infomrmation essential to specimen
processing. Requests for identificatian of the patient, the
diagnosis, demographic data or other such information shall be
referred to the NCI Project Officer.
The Contractor shall never send out the last vial from a
particular specimen without explicit authorization from the
Project Officer.
Statement of Work Attachment #1
02/97 Page 4 of 6
Contract No. N02-CP-71001
The Contractor shall prepare specimens for shipment, supply
shipping containers appropriate to maintain specimens in the
proper state (cool, frozen, deep frozen, etc.) and make
arrangements through commercial air freight companies and other
carriers to send biologic specimens to collaborating
investigators in an expeditious (e.g., overnight or same day)
fashion. For immunologic or genetic typing studies, the
Contractor shall prepare specimens for delivery to the local HLA
typing laboratory or immune function laboratory in a suitable
form. The local in-house delivery service shall be used for these
particular specimens to ensure expeditious delivery under optimum
conditions. In some cases, commercial freight companies shall be
used in overnight shipments to investigators in other cities. The
Contractor shall be responsible for notifying the receiving
laboratory of the specimens' shipment and anticipated arrival
time to insure that the receiving laboratory is prepared to
receive the specimens. All specimens for both immunologic testing
and HLA typing and serum or other type storage shall be processed
by the Contractor. Peripheral blood cells shall be aliquotted for
storage in suitable quantities for subsequent testing. Other
specimens, such as red blood cells, plasma, serum, urine, stool,
tumor tissue, and body fluids shall be processed for storage in
appropriate aliquots.
12) The Contractor shall be prepared to process the following
quantities of materials:
Typical Total
Max Daily Vials Monthly Volume
Material /person /person (Individual Samples)
- ----------------------------------------------------------------------------
WBC Cryopreservation 1,500 cc (60) 5 15,000 cc (250)
Plasma/serum aliquotting 2,500 cc (60) 6-12 25,000 cc (250)
RBC cryopreservation 250 cc (25) 5 750 cc (75)
Pelleted lymphocytes 150 cc (15) 4 600 cc (60)
Buffy coat preps 200 cc (20) 2 300 cc (30)
Receipt frozen vials 10,000 vials any 120,000 vials
Thawing/ aliquotting N/A any 500 vials
Dispersal specimens N/A any 4,000 vials
Although these are ESTIMATES of the amount of work, the
Contractor must be able to accommodate highly variable amounts of
processing and possible changes in specimen types and volumes
depending on the new studies evolving during the contract (e.g.
increased processing of buccal swabs and rinses; gastric juice;
feces; urine, etc.). All prioritization of the specimen
processing is determined by the NCI Project Officer. Not all
maximal quantities of each material will arrive on a given day.
For this aspect of the contract, it is anticipated that
technicians shall be available at least one day per weekend
through the entire period of this contract (the weekend blood
samples will be less than 200 ml and from less than five donors).
Statement of Work Attachment # 1
02/97 Page 5 of 6
Contract No. N02-CP-71001
13) The Contractor shall handle international shipments of biological
specimens (blood components, urine, gastric juice, and biopsy
specimens) and clearance of these shipments through U.S. and
foreign customs. The Contractor must provide a separate
shipping/customs agent to coordinate shipping clear specimens
through customs at U.S. entry port, transfer to appropriate
courier/express delivery service for shipment within the U.S.,
and notify Contractor of all arrangements so that specimens can
be easily tracked. Close coordination is vital because these
samples may need to be kept frozen with dry ice, and
freezer-to-freezer shipping time must be less than 72 hours.
Delays of just one or two days will seriously jeopardize months
of scientific and medical work. Large quantities of samples are
shipped from Europe, the East Indies, Africa, China and other
geographic locales. In each instance, the repository Contractor
shall have responsibility for coordinating logistics to insure
their timely arrival, including contracting with appropriate
customs brokers and agents to expedite shipment and customs
clearances.
Statement of Work Attachment # 1
02/97 Page 6 of 6
Contract No. NO2-CP-71001
INVOICE/FINANCING REQUEST INSTRUCTIONS
--------------------------------------
FOR NIH COST-REIMBURSEMENT TYPE CONTRACTS, NIH(RC)-1
----------------------------------------------------
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 Form NIH 2706, Financial Report
of Individual Project/Contract, or on the payee's letterhead 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.
Bi11ing of Costs Incurred: If billed costs include: (1) Costs of a prior billing
period, but not previously billed, or (2) costs incurred during the contract
period and claimed after the contract period has expired, the amount and
month(s) in which such costs were incurred shall be cited.
Contractor's Fiscal Year: Invoices/financing requests shall be prepared in such
a manner that costs claimed can be identified with the Contractor's fiscal year.
Currency: All NIH contracts are expressed in United States dollars. Where
expenditures are made in a currency other than United States dollars, billings
on the contract shall be expressed, and reimbursement by the United States
Government shall be made, in that other currency at amounts coincident 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 Approva1: Costs requiring the Contracting Officer's
approval which are not set forth in an advance understanding in the contract
sball be so identified and reference the Contracting Officer's Authorization
(COA) number.
Invoice/Financing Request Identification: Each invoice/financing request shall
be identified as either:
(a) Interim Invoice/Contract Financing Request: These are interim payment
requests submitted during the contract performance period.
(b) Completion Invoice: The completion invoice is a final invoice which is
submitted promptly upon completion of the work, but no later than one year
from the contract completion date. The completion invoice should be
submitted when all costs (except for finalization of indirect cost rates)
have been assigned to the contract and all performance provisions have been
completed.
(c) Fina1 Invoice: A revised final invoice may be required after the amounts
owed have been settled between the Govermnent and the Contractor (e.g.,
final indirect cost rates and resolution of all suspensions and audit
exceptions).
Preparation and Itemization of the Invoice/Financing Request: The Contractor
shall furnish the information set forth in the explanatory notes below. These
notes are keyed to the entries of the sample invoice/financing request.
NIH(RC)-1 ATTACHMENT #2
Rev. 6/18/92 Page 1
Contract No. NO2-CP-71001
(a) Payor's Name and Address: The paying office and address, identifier in the
Invoice Submission clause of the contract, shall be entered on all copies of
the invoice/financing request.
(b) Invoice/Financing Request Number: Insert the appropriate serial number of
the invoice/financing request.
(c) Date Invoice/Financing Request Prepared: Insert the date the
invoice/financing request is prepared.
(d) Contract Number and Date: Insert the contract number and the date of the
contract.
(e) Payee's Name and Address: Show the Contractor's name (as it appears in the
contract), correct address, and the title and phone number of the
responsible offficial to whom payment is to be sent. When an approved
assignment has been made by the Contractor, or a different payee has been
designated, then insert the name and address of the payee instead of the
Contractor.
(f) Total Estimated Cost of Contract: Insert the total estimated cost of the
contract, exclusive of fixed-fee. For incrementally funded contracts, enter
the amount currently obligated and available for payment.
(g) Total Fixed-Fee: Insert the total fixed-fee (where applicable).
(h) Billing Period: Insert the beginning and ending dates (day, month, and year)
of the period in which costs were incurred and for which reimbursement is
claimed.
(i) Amount Billed for Current Period: Insert the amount billed for the major
cost elements, adjustment and adjusted amounts for the period.
(j) cumulative Amount from Inception to Date of this Billing: Insert the
cumulative amount billed for the major cost elements and adjusted amounts
claimed during this contract.
(k) Direct Costs: Insert the major cost elements. For each element, consider
the application of the paragraph entitled Costs Requiring Prior Approval on
page 1 of these instructions.
(1) Direct Labor: This consists of salaries and wages paid (or accrued)
for direct performance of the contract.
(2) Fringe Benefit: This represents fringe benefits applicable to direct
labor and billed as a direct cost. Fringe benefits included in indirect
costs should not be identified here.
(3) Accountable Personal Property: This category of cost includes permanent
research equipment and general purpose equipment having a unit
acquisition cost of $1,000 or more and having an expected service life
of more than two years, and sensitive property regardless of cost (See
the DHHS Contractor's Guide for Control of Government Property.) Show
permanent research equipment separate from general purpose equipment.
Prepare and attach Form HHS 565, Report of Accountable Property," in
accordance with the following instructions:
List each item for which reimbursement is requested. A reference shall
be made to the following (as applicable):
(A) The item number for the specific piece of equipment listed in the
Property Schedule;
(B) The Contracting Officer's Authorization letter and number, if the
equipment is not covered by the Property Schedule, or;
(C) Be preceded by an asterisk (*) if the equipment is below the
approval level.
Further itemization of invoices/financing requests shall only be
required for items having specific limitations set forth in the
contract.
NIH(RC)-1 ATTACHMENT #2
Rev. 6/18/92 Page 2
Contract No. NO2-CP-71001
(4) Materials & Supplies: This category includes equipment with unit costs
of less than $500 or an expected service life of two years or less, and
consumable material and supplies regardless of amount.
(5) Premium Pay: This is remuneration in excess of the basic hourly rate.
(6) Consultant Fee: Fees paid to consultants. Identify consultant by name
or category as set forth in the contract's advance understanding or in
the COA letter, as wel1 as the effort (i.e., number of hours, days,
etc.) and rate being billed.
(7) Travel Foreign travel is travel outside of Canada, the United States
and its territories and possessions. However, for an organization
located outside Canada, the United States and its territories and
posessions, foreign travel means travel outside that country. Foreign
travel should be billed separately from domestic travel.
(8) Subcontract Costs: List subcontractor(s) by name and amount billed.
(9) Other: List all other direct costs in total unless exceeding $1,000 in
amount. If over $1,000, list cost elements and dollar amount
separately. If the contract contains restrictions on any cost element,
that cost element should be listed separately.
(l) Cost of Money (COM): Cite the COM factor and base in effect during the time
the cost was incurred and for which reimbursement is claimed.
(m) Indirect Costs Overhead: Cite the formula (rate and base) in effect during
the time the cost was incurred and for which reimbursement is claimed.
If special rate is being used; e.g., off-site, then so specify.
(n) Fixed-Fee: If the contract provides for a fixed-fee, it must be claimed as
provided for by the contract. Cite the formula or method of computation.
(o) Total Amounts Claimed: Insert the total amounts claimed for the current and
cumulative periods.
(p) Adjustments: This includes amounts conceded by the Contractor, outstanding
suspensions and disapprovals subject to appeal.
(q) Grand Totals: The Contracting Officer may require the Contractor to submit
detailed support for costs claimed on one or more interim invoices/financing
requests.
NIH(RC)-1 ATTACHMENT #2
Rev. 6/18/92 Page 3
Contract No. N02-CP-71001
SAMPLE INVOICE/FINANCING REQUEST
- --------------------------------------------------------------------------------
(a) Payor's Name and Address (b) Invoice/financing Requed No.
NATIONAL INSTITUTES OF HEALTH
Division of Financial Management
Contract Accounting Branch, DBS (c) Date Voucher Prepared
Building 31, Room B1B05A
31 CENTER DR MSC 2050
BETHESDA MD 20892-2050 (d) MAO No. and Date
- --------------------------------------------------------------------------------
(e) Payee's Name and Address (f) Total Estimated Cod of MAO
ABC CORPORATION
100 Main Street
Anywhere, U.S.A. Zip Code
(g) Total Fixed Fee
-----------------------------------
Attention: Name, Title and Phone Number of
Official to Whom Payment is Sent
- --------------------------------------------------------------------------------
(h) This invoice/financing request represents reimbursable costs from August 1,
1992 through August 31, 1992.
- --------------------------------------------------------------------------------
<TABLE>
<CAPTION>
<S> <C> <C>
(i) Amount Billed for (j) Cumulative Amount From Inception
Current Period to Date of this Billing
(k) Direct Costs
(l) Direct labor $ 3,400 $ 6,800
(2) Fringe Benefits 600 1,200
(3) Accountable Personal Property
(Attach HHS 565)
Permanent Research 3,000 8,000
General Purpose 2,000 2,000
(4) Materials and Supplies 2,000 4,000
(5) Premium Pay 100 150
(6) Consultant Fee 100 100
Dr. Jones/1 day @, 100-COA #3
(7) Travel - Domestic 200 200
Foreign 200 200
(8) Subcontract Cost 0 0
(9) Other $ 0 $ 0
Total Direct Costs $11,600 $20,650
(l) Cost of Money 2,400 3,6OO
(Factor) or (Appropriate Base)
4,000 6,000
(m) Indirect Costs - Overhead
% of Direct Labor or Other Base
(Formula)
700 1,400
(n) Fixed-Fee Earned (Formula)
$18,700 $31,650
(o) Total Amount Claimed
(p) Adjustments
Outstanding Suspensions
$18,700 $29,950
(q) Grand Totals
</TABLE>
"I certify that all payments requested are for appropriate purposes and in
accordance with the contract."
________________________ ______________
(Name of Official) (Title)
- --------------------------------------------------------------------------------
NIH(RC)-1 ATTACHMENT #2
Rev. 6/18/92 Page 4
<TABLE>
<CAPTION>
Contract No. NO2-CP-71001
- ------------------------------------------------------------------------------------------------------------------------------------
<S> <C> <C> <C> <C> <C> <C> <C>
National Institutes of Health Project Task: Contract No.: Date of Report:
FINANCIAL REPORT OF INDIVIDUAL N02-CP-71001 0990-0131
PROJECT/CONTRACT, NIH FORM 2706
Note: Complete this Form in ---------------------------------------------------------------------------------------------
Accordance with Accompanying Reporting Period: Contractor Name and Address:
Instructions. BTRL Contracts & Services, Inc. dba/Biotech Research Laboratories.
3 Taft Court
Rockville, MD 20850
- ------------------------------------------------------------------------------------------------------------------------------------
Percentage of Cumulative Incurred Cumulative Estimated Estimated Cost Funded Contract Variance (Over
Expenditure Effort/Hours Incurred Cost Cost Cost to Date Cost to at Completion Amount or Under)
Category at End of Prior Current (D + E) Complete (F & G) (I - H)
Funded Actual Period
- ------------------------------------------------------------------------------------------------------------------------------------
A B C D E F G H I J
- ------------------------------------------------------------------------------------------------------------------------------------
Professional Staff 4,864 $104,245
Laboratorv Staff 7,488 $ 96,963
Administrative/Other 6,268 $ 70,146
Total Direct Labor 18,620 $271,354
Overhead $312,057
Materials $101,738
ODC's $ 30,143
Equipment $ 66,745
G&A $ 86,024
TOTAL COST $868,060
Fee $ 47,743
TOTAL CPFF $915,803
</TABLE>
NIH 2706 (5/92) (Formerly HHS-646) ATTACHMENT #3
Contract No. NO2-CP-71001
INSTRUCTIONS FOR COMPLETING FORM NIH 2706
"FINANCIAL REPORT OF INDIVIDUAL PROJECT/CONTRACT"
GENERAL INFORMATION
PURPOSE. Form NIH 2706 is designed to: (1) provide a management tool for use by
NIH in monitoring the application of financial and personnel resources to NIH
contracts, (2) provide contractors with financial and personnel management data
which is usable in their management processes, (3) promptly indicate potential
areas of contract underruns or overruns by making possible comparisons of actua1
performance and projections with prior estimates on individual elements of cost
and personnel and (4) obtain contractor's analyses of cause and effect of
significant variations between actual and prior estimated of financial and
personnel performance.
REPORTING REQUIREMENTS
(a) SCOPE. The specific cost and personnel elements to be reported shall be
established by mutual agreement prior to award. The Government may reqiure the
contractor to provide detailed documentation to support any element(s) on one or
more financial reports.
(b) NUMBER OF COPIES AND MAILING ADDRESS. An original and two (2) copies of the
report(s) shall be sent to the Contracting Officer at the address shown on the
face page of the contract, no later than the 30th working day after the end of
the period reported.
REPORTING STATISTICS
A modification which extends the period of performance of an existing contract
will not reqiure reporting on a separate Form NIH 2706, except where it is
determined by the Contracting Officer that separate reporting is necessary.
Furthermore, when incrementally funded contracts are involved, each separate
allotment is not considered a separate contract entity (only a funding action).
Therefore, the statistics under incrementally funded contracts should be
reported cumulatively from the inception of the contract through completion.
DEFINITIONS AND INSTRUCTIONS FOR COMPLETING FORM NIH 2706. For the purpose of
establishing expenditure categories in Column A, the following definitions and
instructions will be utilized. Each contract will specify the categories to be
reported.
(1) PERSONNEL-PROFESSIONAL. Included are the senior level and all other
personnel whose total annual salary rates are $50,000 or more. It should include
key personnel regardless of annnn1 salary rates. All such individuals should be
listed by names and job titles on a separate line including those whose salary
is not directly charged to the contract but whose effort is directly associated
with the contract. The listing must be kept up to date.
(2) PERSONNEL--OTHER. This will be listed as one amount unless otherwise
required by the contract.
(3) FRINGE BENEFITS. Include allowances and services provided by the Contractor
to employees as compensation in addition to regular salaries and wages. If a
fringe benefit rate(s) has been established, identify the base, rate, and amount
billed for each category. If a rate has not been established, the various fringe
benefit costs may be required to be shown separately. Fringe benefits which are
included in the indirect cost rate should not be shown here.
(4) ACCOUNTABLE PERSONAL PROPERTY. Nonexpendable personal property with an
acquisition cost of $1,000 or more and with an expected useful life of two or
more years, and sensitive items regardless of cost. Form HHS 565, "Report of
Accountable Property, must accompany the contractor's public voucher (SF
1034/SF 1035) or this report if not previously submitted. See "Contractor's
Guide for Control of Government Property."
Form NIH 2706, Instructions ATTACHMENT #4
(5/92) Page 1
Contract No. NO2-CP-71001
(5) SUPPLIES. Includes the cost of supplies and material and equipment charged
directly to the contract, but excludes the cost of nonexpendable equipment as
defined in (4) above.
(6) INPATIENT CARE. Costs associated with a subject while occupying a bed in a
patient care setting. It normally includes both routine and ancillary costs.
(7) OUTPATIENT CARE. Costs associated with a subject while not occupying a bed.
It normally includes ancillary costs only.
(8) TRAVEL. Includes all direct costs of travel, including transportation,
subsistence and miscellaneous expenses. Travel for staff and constants shall be
shown separately. Identify foreign and domestic travel separately. If required
by the contract, the following information shall be submitted: (i) Name of
traveler and purpose of trip; (ii) Place of departure, destination and return,
including time and dates; and (iii) Total cost of trip.
(9) CONSULTANT FEE. Fees paid to consultant. Identify each consultant with
effort expended, billing rate, and amount billed.
(10) PREMIUM PAY. Includes the amount of salaries and wages over and above the
basic rate of pay.
(11) SUBCONTRACTS. List each subcontract by name and amount billed.
(12) OTHER COSTS. Includes a number of separate expenditure categories for which
the Government does not require individual line item reporting. It may include
some of the above categories.
(13) OVERHEAD/INDIRECT COSTS. Identify the cost base, indirect cost rate, and
amount billed for each indirect cost category.
(14) GENERAL AND ADMINISTRATIVE EXPENSE. Cite the rate and the base. In the case
of nonprofit organizations, this item will usually be included in the indirect
cost.
(15) FEE. If any, cite the fee earned.
(16) TOTAL COSTS TO THE GOVERNMENT.
PREPARATION INSTRUCTIONS
These instructions are keyed to the columns on Form NIH 2706.
COLUMN A--EXPENDITURE CATEGORY. Enter in column A the expenditure categories
required by the contract.
COLUMN B--PERCENTAGE OF EFFORT/HOURS FUNDED. Enter in column B the percentage
of effort or number of hours agreed to during contract negotiations for each
labor category listed in column A.
COLUMN C--PERCENTAGE OF EFFORT/HOURS-ACTUAL. The Contractor will enter the
cumulative percentage of effort or number of hours worked by each employee or
group of employees listed in Column A.
COLUMN D--CUMULATIVE INCURRED COST AT END OF PRIOR PERIOD. This column should
show the cumulative incurred, costs up to the end of the prior reporting period.
This column will be blank at the time of the submission of the initial report.
COLUMN E--INCURRED COST-CURRENT PERIOD. The Contractor should enter the costs
which were incurred during the current period.
Form NIH 2706, Instructions ATTACHMENT #4
(5/92) Page 2
Contract No. NO2-CP-71001
COLUMN F-CUMULATIVE INCURRED COST TO DATE. The Contractor should enter the
combined tota1 of Columns D and E.
COLUMN G-ESTIMATED COST TO COMPLETE. Entries need only be made when the
Contractor estimates that a particular expenditure category will vary from the
amount funded. Realistic estimates are essential.
COLUMN H-ESTIMATED COSTS AT COMPLETION. No entry is required in this column
unless an entry is made in Column G.
COLUMN I-FUNDED CONTRACT AMOUNT. Enter in this column the costs agreed to during
contract negotiations for all expenditure categories listed in Column A.
COLUMN J-VARIANCE (OVER OR UNDER). This column need not be filled in when Column
H is blank. When entries have been made in Column H, this column should show the
difference between the estimated costs at completion (Column H) and funded costs
(Column 1). When a line item varies by plus or minus 10%, i.e., the percentage
arrived at by dividing Column J by Column I, an explanation of the variance
should be submitted. In the case of an overrun (net negative variance), this
submission shall not be deemed as notice under the Limitation of Cost (Funds)
clause of the contract.
MODIFICATIONS. Any modification in the amount funded for an item since the
preceding report should be listed in the appropriate cost category.
EXPENDITURES NOT FUNDED. An expenditure for an item for which no amount was
funded (e.g., at the discretion of the Contractor in performance of its
contract) should be listed in the appropriate cost category and all columns
filled in except for I. Column J will of course show a 100% variance and will be
explained along with those identified under J above.
Form NIH 2706, Instructions ATTACHMENT #4
(5/92) Page 3
N02-CP-71001
SCHEDULE I-B
TOTAL
ITEM QUANTITY UNIT PRICE COST
--------------------------------------------------------------------
YEAR 1
Mechanical Freezers (incl freight) 4 $5,875.00 $23,500
Chart Recorders 4 $ 540.00 $ 2,160
Racks, 13-2-C-81 154 $ 81.00 $12,474
Racks, 8-3.75-C81 29 $ 63.30 $ 1,836
Racks, Robot 61 $ 90.00 $ 5,490
LN2 Freezer 1 $21,285.00 $21,285
YEAR 1 TOTAL ESTIMATED COST $66,745
OPTION I
YEAR 2 Mechanical Freezers (incl freight) 4 $6,051.25 $24,205
Chart Recorders 4 $ 556.20 $ 2,225
Racks, 13-2-C-81 154 $ 83.43 $12,848
Racks, 8-3.75-C81 29 $ 65.20 $ 1,891
Racks, Robot 61 $ 92.70 $ 5,655
LN2 Freezer 1 $21,923.55 $21,924
OPTION I TOTAL ESTIMATED COST $68,747
OPTION II
YEAR 3 Mechanical Freezers (incl freight) 4 $6,232.79 $24,931
Chart Recorders 4 $ 572.89 $ 2,292
Racks, 13-2-C-81 154 $ 85.93 $13,233
Racks, 8-3.75-C81 29 $ 67.15 $ 1,947
Racks, Robot 61 $ 95.48 $ 5,824
LN2 Freezer 0 $ 0.00 $ 0
OPTION II TOTAL ESTIMATED COST $48,228
OPTION III
YEAR 4 Mechanical Freezers (incl freight) 4 $6,419.77 $25,679
Chart Recorders 4 $ 590.07 $ 2,360
Racks, 13-2-C-81 154 $ 88.51 $13,631
Racks 8-3.75-C81 29 $ 69.17 $ 2,006
Racks Robot 61 $ 98.35 $ 5,999
LN2 Freezer 1 $23,238.96 $23,239
OPTION III TOTAL ESTIMATED COST $72,914
OPTION VI
YEAR 5 Mechanical Freezers (incl freight) 4 $6,612.36 $26,449
Chart Recorders 4 $ 607.77 $ 2,431
Racks, 13-2-C-81 154 $ 91.17 $14,040
Racks, 8-3.75-C81 29 $ 71.24 $ 2,066
Racks, Robot 61 $ 101.30 $ 6,179
LN2 Freezer 0 $ 0.00 $ 0
OPTION VI TOTAL ESTIMATED COST $51,166
Schedule I-B Attachment #5
N01-CP-71001
<TABLE>
<CAPTION>
Gov
Item Descripeion Mfr. Model# Serial# Decal# Cost($)
- -------------------------------------------------------------------------------------------------------
<S> <C> <C> <C> <C> <C> <C>
1 Mechanical Freezer Forma 8158 80638-004 01029103 $ 1,780.00
2 Mechanical Freezer Forma 8158 80638-003 01029102 $ 1,780.00
3 Mechanical Freezer Forma 8158 80638-005 01029104 $ 1,780.00
4 Mechanical Freezer Forma 8358 81043-402 01029124 $ 4,680.00
5 Mechanical Freezer Forma 8358 69566-1 01029107 $ 4,539.00
6 Mechanical Freezer Forma 8158 80856-007 01029105 $ 4,850.00
7 Mechanical Freezer Forma 8358 82189-762 01029129 $ 4,729.00
8 Mechanical Freezer Forma 8358 69566-2 01029118 $ 4,539.00
9 Mechanical Freezer Forma 8358 69929-77 01029116 $ 4,539.00
10 Mechanical Freezer Forma 8158 80856-008 01029106 $ 4,850.00
11 Mechanical Freezer Forma 8358 60091-118 01029119 $ 4,539.00
12 Mechanical Freezer Forma 8358 60091-119 01029120 $ 4,539.00
13 Mechanical Freezer Forma 8358 60342-261 01029121 $ 4,732.00
14 Mechanical Freezer Forma 8358 80128-320 01029123 $ 4,680.00
15 Mechanical Freezer Forma 8358 81391-455 01029125 $ 4,680.00
16 Mechanical Freezer Forma 8358 81611-479 01029126 $ 4,680.00
17 Mechanical Freezer Forma 8358 82004-659 01029127 $ 4,275.00
18 Mechanical Freezer Forma 8358 82004-658 01029128 $ 4,275.00
19 Mechanical Freezer Forma 8358 82154-858 01029130 $ 4,857.00
20 Mechanical Freezer Forma 8358 82154-857 01029131 $ 4,857.00
21 Mechanical Freezer Forma 8358 82154-860 01029132 $ 4,857.00
22 Mechanical Freezer Forma 8458 83029-220 01029133 $ 4,743.00
23 Mechanical Freezer Forma 8458 83029-219 01029l34 $ 4,743.00
24 Mechanical Freezer Forma 8458 83071-225 01029135 $ 4,743.00
25 Mechanical Freezer Forma 8458 83071-256 01029136 $ 4,743.00
26 Mechanical Freezer Solow SE27-120 8889645 01023092 $ 4,503.00
27 Mechanical Freezer Forma 8458 83327-403 01029137 $ 5,028.00
28 Mechanical Freezer Forma 8458 83327-402 01029138 $ 5,028.00
29 Mechanical Freezer Solow SE27-120 8889646 01023091 $ 4,053.00
30 Mechanical Freezer Forma 8458 83510-578 00811080 $ 4,473.00
31 Mechanical Freezer Forma 8458 83510-576 00811081 $ 4,473.00
32 Mechanical Freezer Forma 8458 84200-719 00811940 $ 5,431.00
33 Mechanical Freezer Forma 8458 84200-720 00811941 $ 5,431.00
34 Mechanical Freezer Solow SE27-120 919768 00871523 $ 5,243.00
35 Mechanical Freezer Solow SE27-120 912769 00871522 $ 5,243.00
36 Liquid Nitrogen Freezer MVE A4500 449-B 01029139 $ 6,909.00
37 Liquid Nitrogen Freezer MVE A1500 481-B 01029141 $ 7,500.00
38 Liquid Nitrogen Freezer MVE A4500 561 01029142 $ 780.00
39 Liquid Nitrogen Freezer MVE A4500 593 01029144 $ 8,952.00
40 Liquid Nitrogen Freezer MVE A4500 595 01029143 $ 8,952.00
41 Liquid Nitrogen Freezer MVE XLC111O DKA88J102 01029145 $ 9,500.00
42 Liquid Nitrogen Freezer MVE A4500 274-B 01029099 $ 3,720.00
43 Liquid Nitrogen Freezer MVE A4500 272-B 01029101 $ 3,720.00
44 Liquid Nitrogen Freezer MVE A4500 276-B 01029100 $ 3,720.00
45 Liquid Nitrogen Freezer MVE A4500 448-B 01029140 $ 6,909.00
46 Liquid Nitrogen Freezer MVE XLC111O DKC89G101 01029146 $10,000.00
47 Liquid Nitrogen Freezer MVE XLC1110 DKC89G103 01029147 $10,000.00
48 Liquid Nitrogen Freezer MVE XLC111O DKD9OB102 01029148 $ 9,870.00
</TABLE>
Attachment #6
Schedule II-A Page 1 of 2
N01-CP-71001
<TABLE>
<CAPTION>
Item Descripeion Mfr. Model# Serial# Decal# Cost($)
- ----------------------------------------------------------------------------------------------------------------------
<S> <C> <C> <C> <C> <C> <C>
49 Liquid Nitrogen Freezer MVE XLC111O DKD9OB101 01029149 $ 9,870.00
5O Liquid Nitrogen Freezer MVE XLC111O DFK9OK110 00811082 $ 10,077.00
51 Liquid Nitrogen Freezer MVE XLC111O DFK9lG101 00811942 $ 9,870.00
52 Liquid Nitrogen Freezer MVE XLC111O JIA92B101 00871521 $ 9,882.00
53 Refirigerator Puffer Hubbard LR-201TU S11138 01029114 $ 880.00
54 Liquid Nitrogen Freezer MVE XLC111O JIA93F113 01175478 $ 9,762.00
55 Liquid Nitrogen Freezer MVE XLC1200 JUA93M103 01096478 $ 9,492.00
56 Liquid Nitrogen Tank MVE 160LDura-Lo L83112112CA 01029156 $ 1,295.00
57 ControlRateFzr-Cntlr, Chamber Cryomed 1010 89-2202L 01029157 $ 10,754.00
58 ControlRateFzr-Cntlr, Chamber Cryomed 900 810501D 01029113 $ 9,870.00
59 Laminar Flow Hood(Labgard) Nuaire, Inc. NU 408-424 4009-MM-A 01029098 $ 182.00
60 Lannnar Flow Hood(Labgard) CII 740 13406 01029111 $ 8,952.00
61 CPU W/Modem & Software Compaq 286 4844AM381292 01029158 $ 2,195.00
62 Printer Epson DFX5OOO OOG0000823 01029184 $ 1,517.00
63 Centrifuge w/Accessories Sorvall T-6000D 9304366 01175994 $ 6,946.00
64 Centrifuge Sorvall CRU-5000 860-1962 01029155 $ 7,325.00
65 Water Bath Precsn Scientific 184 22AM/6 01029110 $ 45O.OO
66 Coulter Counter Coulter Electron ZB-1 5632 01029112 $ 650.00
67 Mechanical ULT Chest Frz Forma 8458 85243-970 01175129 $ 5,128.00
68 Mechanical ULT Chest Frz Forma 8458 85243-972 01175130 $ 5,128.00
69 ULT Chest freezer Forma 8458 85471-1017 01096558 $ 4,890.00
70 ULT Chest freezer Forma 8458 85471-1019 01096559 $ 4,890.00
71 Chest Freezer So-Low C85-27 9394788 01182917 $ 4,975.00
72 Liquid Nitrogen Dry Shipper Cryomed CMD-20 CMD~20-1 00916815 $ 1,100.00
73 Liquid Nitrogen Freezer MVE XLC-1830HE JOA94E101 01190560 $ 18,823.00
74 Chest Freezer So-Low C85-27 9495071 01190561 $ 4,975.00
75 Chest Freezer So-Low C85-27 9495319 01190562 $ 5,075.00
76 Chest Freezer So-Low C85-27 9495320 01190563 $ 5,075.00
77 Chest Freezer So-Low C85-27 9495743 00941700 $ 5,075.00
78 Chest Freezer So-Low C85-27 9495744 00941701 $ 5,075.00
79 LN2 Freezer MCE/CRYO XLC1830HE CDNB95F103 00941672 $ 20,102.00
80 Chest Freezer So-Low C80-27 9596411 01250392 $ 5,845.00
81 Chest Freezer So-Low C80-27 9596412 01250393 $ 5,320.00
82 LN2 Freezer Cryomed XLC-1830HE CDN96K101 01264045 $ 21,285.00
83 HP Vector P-100 PC, 850mb HD HP Vectra Series 4 US61559762 01264046 $ 1,525.00
84 14" Monitor HP 1024 TW63042334 01264047 $ 350.00
85 Power Supply Station APC 450AMP 096097611010 01264048 $ 230.00
86 Chest Freezer So-Low C80-27 9697237 01213988 $ 5,915.00
87 Chest Freezer So-Low C80-27 9697238 01213989 $ 5,915.00
88 Diesel Generator Cummins 350DFCC 01213110 $ 40,300.00
89 Chest Freezer So-Low C85-27 01264569 $ 6,100.00
90 Chest Freezer So-Low C85-27 01264570 $ 6,100.00
91 Chest Freezer So-Low C85-27 01264571 $ 6,100.00
92 Chest Freezer So-Low C85-27 01264572 $ 6,100.00
93 Chest Freezer So-Low C85-27 01264573 $ 6,100.00
94 Chest Freezer So-Low C85-27 01264574 $ 6,100.00
95 Chest Freezer So-Low C85-27 01264575 $ 6,100.00
96 Walk-In Refrigerator Hartford 01264576 $ 7,776.00
97 Walk-In Freezer Hartford 01264577 $ 9,250.00
98 Printer Epson DFX5000 01264578 $ 1,750.00
</TABLE>
Attachment #6
Schedule II-A Page 2 of 2
Contract No. N02-CP-71001
FEDERAL REGISTER / VOL. 56, NO. 8 / FRIDAY, JANUARY 11, 1991 / NOTICES
================================================================================
SYSEMS EXEMPT FROM CERTAIN PROVISIONS OF THE ACT:
None.
09-25-0130
SYSTEM NAME:
Clinical Research: Environmental Epidemiologic Studies in the Division of Cancer
Etiology, HHS/NIH/NCI.
SECURITY CLASSIFICATION:
None.
SYSTEM LOCATION:
National Institutes of Health, Executive Plaza North, room 443, 6130
Executive Blvd., Bethesda, MD 20892; and National Institutes of Health, Building
12, 9000 Rockville Pike, Bethesda, MD 20892, and at hospitals, medical schools,
universities, research institutions, commercial organizations, state agencies,
and collaborating governmental agencies. A list of locations and contracts is
available upon request from the system manager.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM
Patients with cancer and other environmentally caused diseases, (e.g., birth
defects), patients with other diseases (e.g., heart disease), normal and other
persons (e.g., family members) for the purpose of making comparisons.
CATEGORIES OF RECORDS IN THE SYSTEM:
Medical records, progress reports, correpondence, epidemiological
computerized data and records on biological specimens (e.g., blood, tumors,
urine, etc.).
AUTHORITY FOR MAINTAINANCE OF THE SYSTEM:
42 U.S.C. 241, and 282.
PURPOSES OF THE SYSTEM:
To determine: (1) Factors or substances in the environment which cause
cancer; (2) ways in which these factors or substances may cause cancer; (3)
characteristics of persons who may be particularly susceptible to the
environmental factor(s) or substance(s) and/or to cancer.
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OF USERS
AND THE PURPOSES OF SUCH USES:
1. Disclosure may be made to HHS contractors, grantees and collaborating
researchers and their staff in order to accomplish the research purpose for
which the records are collected. The recipients are required to protect such
records from improper disclosure.
2. Disclosure may be made to a congessional office from the record of
Privacy Act System of Record Attachment #7
Page 1 of 2
Contract No. N02-CP-71001
FEDERAL REGISTER / VOL. 56, NO. 8 / FRIDAY, JANUARY 11, 1991 / NOTICES
================================================================================
an individual in response to an inquiry from the congressional office made at
the request of the individual.
3. The Department contemplates that it will contract with a private firm for
the purpose of collating, analyzing, aggregating or otherwise refining records
in this system. Relevant records will be disclosed to such a contractor. The
contractor shall be required to maintain Privacy Act safeguards with respect to
such records.
4. In the event of litigation where the defendant is (a) the Department,
any component of the Department, or any employee of the Department in his or her
official capacity; (b) the United States where the Department determines that
the claim, if successful, is likely to directly affect the operations of the
Department or any of its components; or (c) any Department employee in his or
her individual capacity where the Justice Department has agreed to represent
such employee, for example in defending against a claim based upon an
individual's mental or physical condition and alleged to have arisen because of
activities of the Public Health Service in connection with such individual, the
Department may disclose such records as it deems desirable or necessary to the
Department of Justice or other appropriate Federal agency to enable that agency
to present an effective defense, provided that such disclosure is compatible
with the purpose for which the records were collected.
POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING, AND
DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
File folders, microfilm, charts, graphs, computer tapes, disks and punch
cards.
RETRIEVABILITY:
By name and/or code number.
SAFEGUARDS:
HHS contractors and collaborating researchers are required to comply with the
provisions of the Privacy Act and with Department Regulations. Subjects
participating in a clinical study are advised that their identity will only be
known to those who are involved in conducting the study and that any published
findings will be in a format which precludes individual identification.
1. Authorized Users: Employees who maintain records in this system are
instructed to grant regular access only to physicians, scientists and support
staff of the National Cancer Institute, collaborating researchers, or HHS
contractors, whose duties require the use of such information. Other one-time
and special access by other employees is granted on a need to know basis as
specifically authorized by the system manager.
2. Physical Safeguards: Data are kept in secured areas with access limited to
authorized personnel (system manager, project officer, contracting officer,
collaborating researchers, staff and HHS contractors). Data transmitted to the
NCI are in form which precludes individual identification.
3. Proceedural Safeguards: For computerized records, the contractor is
required to comply, where appropriate, with Departmental standards, and National
Bureau of Standards Guidelines. For example, access is controlled by the use of
security codes known only to authorized personnel.
These practices are in compliance with the standards of Chapter 45-13 of the
HHS General Administration Manual, "Safeguarding Records Contained in Systems of
Records," supplementary Chapter PHS hf: 45-13, and Part 6, "ADP Systems
Securites," of the HHS Information Resources Management Manual and the National
Institute of Standards and Technology Federal Information Processing Standards
(FIPS Pub. 41 and FIPS Pub. 31).
RETENTION AND DISPOSAL
Records are retained and disposed of under the authority of the NIH Records
Control Schedule contained in NIH Manual Chapter 1743, Appendix 1- "Keeping and
Destroying Records" (HHS Records Management Manual, Appendix B-361), item 3000
G-3, which allows records to be kept as long as they are useful in scientific
research. Refer to the NIH Manual Chapter for specific disposition instructions.
SYSTEM MANAGER AND ADDRESS:
National Cancer Institute, Chief Environmental Epidemiology Branch, Executive
Plaza North, room 443, 6130 Executive Blvd., Bethesda, Maryland 20892.
NOTIFICATION PROCEDURE:
To determine if a file exists, write to System Manager and provide the
following information:
a. System name: Environmental Epidemiologic Studies in the Division of Cancer
Cause and Prevention;
b. Complete Name at time of study;
c. Facility and Home Address at the time the study was undertaken;
d. Date(s) at the time the information was provided (if known);
e. Birth date;
f. Disease type (if known).
The requester must also verify his or her identity by providing either a
notarization of the request or a written certification that the requestor is who
he or she claims to be and understands that the knowing and willful request for
aquisition of a record pertaining to an individual under false pretenses is a
criminal offense under the Act, subject to a five thousand dollar fine.
Individuals seeking notification of or access to medical records should
designate a representative (including address) who may be a physician, other
health professional, or other responsible individual who would be willing to
review the record and inform the subject individual of its contents, at the
representative's discretion.
A parent or guardian who requests notification of, or access to, a child's or
incompetent person's medical record shall designate a family physician or other
health professional (other than a family member) to whom the record, if any,
will be sent. The parent or guardian must verify relationship to the child or
incompetent person as well as his or her own identity.
RECORD ACCESS PROCEDURE:
Write to System Manager and specify the record sought. The same information
required above for notification is also needed for access. Individuals may also
request listings of accoutable disclosures that have been made of their records,
if any.
CONTESTING RECORD PROCEDURE:
Write to System Manager and Specify the record and the part(s) to be
contested, and state the corrective action sought and the reasons for the
correction. The right to contest records is limited to information which is
incomplete, irrelevant, incorrect, or untimely (obsolete).
RECORD SOURCE CATEGORIES:
HHS agencies, institutions under contract to the U.S. Government,
universities, medical schools, hospitals, research institutions, commercial
institutions, state agencies, other U.S. Government agencies, patients and
normal volunteers, physicians, research investigators and other collaborating
personnel.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
None
Privacy Act System of Record Attachment #7
Page 2 of 2
Contract No. NO2-CP-71001
PHS 352 223-70 SAFETY AND HEALTH (APRIL 1984)
(a) In order to provide safety controls for protection to the life and health of
employees and other persons; for prevention of damage to all property; and
for avoidance of work interruptions in the performance of the contract; the
Contractor will 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) Recommendations for Prevention of HIV Transmission in Health-Care
Settings, Morbidity and Mortality Report, August 21, 1987, Vol. 35, No.
2S.
(3) Update: Universal Precautions for Prevention of Transmission of Human
Immunodeficiency Virus, Hepatitis B Virus, and Other Bloodborne
Pathogens in Health-Care Settings. Morbidity and Mortality Weekly
Report, June 24, 1988, Vol. 37, No. 24.
(4) Agent Summary Statement for Human Immunodeficiency Viruses (HIV);
Included are GTLV-III, LAV, HIV-1, and HIV-2. Morbidity and Mortality
Weekly Report, April 1, 1988, Vol. 37, No. S4.
(5) Recommendations for the Safe Handling of Parentoral Antineoplastic
Drugs, NIH Publication No. 83-2621.
(6) NIH Guidelines for the Laboratory Use of Chemical Carcinogens, NIH
Publication No. 81-2385.
The above, (1) - (6), may be obtained from:
Division of Safety
Office of Research Services
National Institutes of Health
Building 31, Room lC02
31 CENTER DR MSC 2260
BETHESDA MD 20892-2260
(7) Guidelines for Research Involving Recombinant DNA Molecules (49 FR
46266 or latest revision) and Administrative Practices Supplemenent.
These may be obtained from:
Office of Recombinant DNA Activities
Office of Science Policy and Legislation
National Institutes of Health
Building 31, Room B1C34
31 CENTER DR MSC 2250
BETHESDA MD 20892-2250
(8) Procedures for the Domestic handling and Transport of Diagnostic
Specimens and Etiologic Agents, National Committee for Clinical
Laboratory Standards, July 17, 1985, Vol. 5. This may be obtained from
National Committee for Clinical Laboratory Standards
771 East Lancaster Avenue
Villanova, Pennsylvania 19085
Further, the Contractor shall take or cause to be taken such additional safety
measures as the Contracting Officer may determine to be reasonably necessary;
provided, that if compliance with such additional safety measures results in a
material increase in the cost or time of performance of the contract, an
equitable adjustment will be made in accordance with the clause of this contract
entitled "Changes".
Safety and Health Clause ATTACHMENT #8
PHS 352.223-70, (4/84) Page 1
Contract No. NO2-CP-71001
(b) Prior to commencement of work, the Contractor will submit in writing its
plan for complying with the safety and health provisions of this contract,
and will meet with the Contracting Officer or his/her designated
representative to discuss and develop a mutual understanding relative to
administration of the overall safety program.
(c) During the performce of work under this contract, the Contractor shall
comply with all procedurres prescribed by the Contracting Officer for the
control and safety of persons Visiting the job site and will comply with
such requirements to prevent accidents as may be prescribed by the
Contracting Officer.
(d) The Contractor will maintain an accurate record of, and report to the
Contracting Officer in such manner as the Contracting Officer may prescribe,
all accidents and incidents resulting in death, traumatic injury,
occupational disease, and/or damage to all property incident to work
performed under the contract.
(e) The Contracting Officer shall notify (if otherwise, confirm in writing) the
Contractor of any noncompliance with the provisions of this clause and
corrective action to be taken. After receipt of such notice, the Contractor
shall immediately take such corrective action. (Such notice, when delivered
to the Contractor or its representative at the site of the work, shall be
deemed sufficient for the purpose.) If the Contractor fails or refuses to
comply promptly, the Contracting Officer may issue an order stopping all or
part of the work until satisfactory corrective action has been taken. No
part of the time lost due to any such stop order shall be the subject of
claim for extension of time or for costs or damages by the Contractor.
(f) The Contractor shall insert the substance of this clause in each subcontract
involving the use of hazardous materials or operatians. Compliance with the
provisions of this clause by subcontractors will be the responsibility of
the Contractor.
(End of clause)
Safety and Health Clause ATTACHMENT #8
PHS 352.223-70, (4/84) Page 2
Contract No. NO2-CP-71001
PROCUREMENT OF CERTAIN EQUIPTMENT
Notwithstanding any other clause in this contract, the Contractor wil1 not be
reimbursed for the purchase, lease, or rental of any item of equiptment 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 #9
OMB Bulletin 81-16
EXHIBIT 11
BOSTON BIOMEDICA, INC. AND SUBSIDIARIES
STATEMENT RE COMPUTATION OF INCOME PER SHARE
WEIGHTED AVERAGE SHARES
Quarter Ended March 31,
----------------------------------
1997 1996
--------------- -----------------
Average common stock outstanding 4,380,024 2,560,417
Net effect of dilutive common stock
equivalents-based on treasury stock
method using average market price 445,558 -
Issuance of "cheap stock" - 4,357
--------------- -----------------
4,825,582 2,564,774
=============== =================
Net income (loss) $ 147,758 $ (96,539)
=============== =================
Net income (loss) per share 0.03 (0.04)
=============== =================
13
<TABLE> <S> <C>
<ARTICLE> 5
<LEGEND>
(Replace this text with the legend)
</LEGEND>
<S> <C>
<PERIOD-TYPE> 3-Mos
<FISCAL-YEAR-END> Dec-31-1997
<PERIOD-START> Jan-01-1997
<PERIOD-END> Mar-31-1997
<CASH> 7,019,559
<SECURITIES> 0
<RECEIVABLES> 3,506,809
<ALLOWANCES> 362,612
<INVENTORY> 4,461,582
<CURRENT-ASSETS> 15,225,172
<PP&E> 5,057,855
<DEPRECIATION> 2,120,501
<TOTAL-ASSETS> 19,781,129
<CURRENT-LIABILITIES> 3,191,166
<BONDS> 37,543
0
0
<COMMON> 15,315,938
<OTHER-SE> 0
<TOTAL-LIABILITY-AND-EQUITY> 19,781,129
<SALES> 2,126,956
<TOTAL-REVENUES> 4,209,049
<CGS> 1,055,422
<TOTAL-COSTS> 4,060,271
<OTHER-EXPENSES> 0
<LOSS-PROVISION> 0
<INTEREST-EXPENSE> 0
<INCOME-PRETAX> 246,264
<INCOME-TAX> 98,506
<INCOME-CONTINUING> 0
<DISCONTINUED> 0
<EXTRAORDINARY> 0
<CHANGES> 0
<NET-INCOME> 147,758
<EPS-PRIMARY> .03
<EPS-DILUTED> .03
</TABLE>
