<PAGE> 1
U.S. SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-QSB
(Mark One)
/X/ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended November 30, 1995
-----------------
OR
/ / TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT
For the transition period from TO
------------ ------------
Commission file number 0-13281
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DIAGNON CORPORATION
-----------------------------------------------------------------
(Exact name of small business issuer as specified in its charter)
State of Delaware 13-3078199
- ---------------------------------------------------------------------
(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification No.)
9600 Medical Center Drive, Rockville, Maryland 20850
- ---------------------------------------------------------------------
(Address of principal executive office) (Zip Code)
Issuer's telephone number, including area code (301) 251-2801
Not Applicable
- ---------------------------------------------------------------------
(Former name, former address and former fiscal year, if changed since
last report)
Check whether the issuer (1) filed all reports required to be filed by Section
13 or 15(d) of the Securities Exchange Act during the past 12 months, and (2)
has been subject to such filing requirement for the past 90 days.
Yes X No
----- -----
Common Stock, $.01 par value per share; authorized 25,000,000 shares; 5,398,244
shares outstanding as of January 8, 1996.
Convertible Preferred Stock, $1.00 par value per share; authorized 325,000
shares; no shares outstanding as of January 8, 1996.
Transitional Small Business Disclosure Format (Check one): Yes No X
--- ---
<PAGE> 2
DIAGNON CORPORATION
INDEX
<TABLE>
<CAPTION>
Part I. Financial Information Page
- ------------------------------ ----
<S> <C>
Item 1. Financial Statements.
Consolidated Balance Sheets, May 31, 1995 and
November 30, 1995 (Unaudited) . . . . . . . . . . . 2
Unaudited Statements of Consolidated Operations for
the Three Months Ended November 30, 1995 and
November 30, 1994 . . . . . . . . . . . . . . . . . 3
Unaudited Statements of Consolidated Operations for
the Six Months Ended November 30, 1995 and
November 30, 1994 . . . . . . . . . . . . . . . . . 4
Unaudited Statements of Consolidated Cash Flows
for the Six Months Ended November 30, 1995 and
November 30, 1994 . . . . . . . . . . . . . . . . . 5
Notes to Financial Statements . . . . . . . . . . . . . 6
Item 2. Management's Discussion and Analysis . . . . . 6
Part II. Other Information
- ---------------------------
Item 4. Submission of Matters to a Vote of
Security Holders . . . . . . . . . . . . . . 8
Item 6. Exhibits . . . . . . . . . . . . . . . . . . . 9
</TABLE>
<PAGE> 3
DIAGNON CORPORATION AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS, MAY 31, 1995 AND NOVEMBER 30, 1995 (UNAUDITED)
<TABLE>
<CAPTION>
NOVEMBER 30, MAY 31,
ASSETS 1995 1995
- ------ --------------- -------------
<S> <C> <C>
CURRENT ASSETS:
Cash and cash equivalents $ 57,098 $ 210,887
Accounts receivable:
Trade 732,322 873,358
Unbilled 1,087,478 728,046
Other 30,331 24,060
Prepaid expenses 132,593 70,513
Inventories 33,156
Deferred income taxes-current 43,800 43,800
--------------- -------------
Total current assets 2,116,778 1,950,664
--------------- -------------
LOANS TO OFFICERS 90,000 90,000
--------------- -------------
FIXED ASSETS:
Leasehold improvements 532,379 532,379
Furniture, fixtures and equipment 2,354,986 2,084,466
--------------- -------------
Total 2,887,365 2,616,845
Less accumulated depreciation
and amortization 1,777,754 1,650,812
--------------- -------------
Fixed assets, net 1,109,611 966,033
--------------- -------------
DEFERRED INCOME TAXES-NONCURRENT 775,400 799,400
--------------- -------------
OTHER NONCURRENT ASSETS 147,867 130,770
--------------- -------------
GOODWILL, NET OF ACCUMULATED
AMORTIZATION 567 1,702
--------------- -------------
TOTAL $ 4,240,223 $ 3,938,569
=============== =============
LIABILITIES
- -----------
CURRENT LIABILITIES:
Borrowings under line of credit $ 223,793
Current maturities of long-term debt 68,367 $ 83,075
Accounts payable 150,871 215,344
Accrued compensation and related costs 278,828 276,247
Accrued income taxes 302
Other accrued liabilities 18,068 9,393
--------------- -------------
Total current liabilities 739,927 584,361
LONG-TERM DEBT 235,565 142,812
--------------- -------------
Total liabilities 975,492 727,173
--------------- -------------
STOCKHOLDERS' EQUITY
- --------------------
Convertible preferred stock - par value of
$1.00 per share, 325,000 shares authorized;
no shares issued and outstanding
Common stock - par value of $.01 per share;
25,000,000 shares authorized; 9,602,452
shares issued; 5,398,244 shares outstanding 96,024 96,024
Additional paid-in capital 7,395,015 7,395,015
Accumulated deficit (3,598,951) (3,652,286)
--------------- -------------
Total 3,892,088 3,838,753
Less - treasury stock 4,204,208 shares, at cost (627,357) (627,357)
--------------- -------------
Total stockholders' equity 3,264,731 3,211,396
--------------- -------------
TOTAL $ 4,240,223 $ 3,938,569
=============== =============
</TABLE>
See notes to financial statements.
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<PAGE> 4
DIAGNON CORPORATION AND SUBSIDIARY
UNAUDITED STATEMENTS OF CONSOLIDATED OPERATIONS FOR THE
THREE MONTHS ENDED NOVEMBER 30, 1995 AND NOVEMBER 30, 1994
<TABLE>
<CAPTION>
NOVEMBER 30, NOVEMBER 30,
1995 1994
------------- ---------------
<S> <C> <C>
CONTRACT REVENUES $ 2,138,159 $ 2,387,745
------------- ---------------
OPERATING EXPENSES:
Contract 1,681,485 1,820,661
General and administrative 416,305 486,707
------------- ---------------
Total 2,097,790 2,307,368
------------- ---------------
OPERATING INCOME 40,369 80,377
INTEREST INCOME (3,797) 635
INTEREST EXPENSE (12,341) (9,769)
------------- ---------------
INCOME BEFORE INCOME TAX 24,231 71,243
PROVISION FOR INCOME TAX 9,900 40,700
------------- ---------------
NET INCOME $ 14,331 $ 30,543
============= ===============
INCOME PER SHARE $ 0.00 $ 0.01
============= ===============
WEIGHTED AVERAGE NUMBER OF
SHARES OUTSTANDING 5,398,244 5,398,244
============= ===============
</TABLE>
See notes to financial statements.
-3-
<PAGE> 5
DIAGNON CORPORATION AND SUBSIDIARY
UNAUDITED STATEMENTS OF CONSOLIDATED OPERATIONS FOR THE
SIX MONTHS ENDED NOVEMBER 30, 1995 AND NOVEMBER 30, 1994
<TABLE>
<CAPTION>
NOVEMBER 30, NOVEMBER 30,
1995 1994
------------- -------------
<S> <C> <C>
CONTRACT REVENUES $ 4,367,507 $ 4,870,722
------------- -------------
OPERATING EXPENSES:
Contract 3,402,346 3,784,111
General and administrative 856,543 909,154
------------- -------------
Total 4,258,889 4,693,265
------------- -------------
OPERATING INCOME 108,618 177,457
INTEREST INCOME 1,003 1,678
INTEREST EXPENSE (19,986) (14,082)
------------- -------------
INCOME BEFORE INCOME TAX 89,635 165,053
PROVISION FOR INCOME TAX 36,300 66,000
------------- -------------
NET INCOME $ 53,335 $ 99,053
============= =============
INCOME PER SHARE $ 0.01 $ 0.02
============= =============
WEIGHTED AVERAGE NUMBER OF
SHARES OUTSTANDING 5,398,244 5,398,244
============= =============
</TABLE>
See notes to financial statements.
-4-
<PAGE> 6
DIAGNON CORPORATION AND SUBSIDIARIES
UNAUDITED STATEMENTS OF CONSOLIDATED CASH FLOWS FOR THE
SIX MONTHS ENDED NOVEMBER 30, 1995 AND NOVEMBER 30, 1994
<TABLE>
<CAPTION>
Six Months Ended Six Months Ended
November 30, 1995 November 30, 1994
----------------- -----------------
<S> <C> <C>
CASH FLOWS FROM OPERATING ACTIVITIES:
Net Income $ 53,335 $ 99,053
----------------- -----------------
Adjustments to reconcile net income to net cash
used for operating activities:
Depreciation and amortization 128,077 176,789
Deferred income taxes 24,000 56,000
Increase in accounts receivable (224,667) (194,092)
Increase in prepaid expenses (62,080) (66,027)
Increase in inventories (33,156)
Increase in other assets (17,097) (81,552)
Decrease in accounts payable and accrued expenses (53,217) (40,411)
Decrease in income taxes payable (302) (11,242)
Decrease in deferred income (74,211)
----------------- -----------------
Total Adjustments (238,442) (234,746)
----------------- -----------------
NET CASH USED FOR OPERATING ACTIVITIES (185,107) (135,693)
----------------- -----------------
CASH FLOWS USED FOR INVESTING ACTIVITIES:
Capital expenditures (142,268) (59,801)
Decrease in loans to officers 6,000
----------------- -----------------
NET CASH USED FOR INVESTING ACTIVITIES (142,268) (53,801)
----------------- -----------------
CASH FLOWS FROM FINANCING ACTIVITIES:
Net proceeds under line-of-credit agreement 223,793 221,213
Principal payments under capital lease obligations (50,207) (32,036)
Other (350)
----------------- -----------------
NET CASH PROVIDED BY FINANCING ACTIVITIES 173,586 188,827
----------------- -----------------
NET DECREASE IN CASH AND CASH EQUIVALENTS (153,789) (667)
CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD 210,887 57,306
----------------- -----------------
CASH AND CASH EQUIVALENTS AT END OF PERIOD $ 57,098 $ 56,639
================= =================
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION
Cash paid during the period for:
Interest $ 19,136 $ 13,093
================= =================
Income taxes $ 13,400 $ 22,000
================= =================
SUPPLEMENTAL SCHEDULE OF NONCASH INVESTING AND
FINANCING ACTIVITIES:
The Company issued:
Long-term debt issued in connection with
capital leases $ 128,252 $ 111,822
================= =================
</TABLE>
See notes to financial statements.
-5-
<PAGE> 7
NOTES TO FINANCIAL STATEMENTS
Interim Financial Statements
In the opinion of management, all adjustments consisting only of normal
recurring accruals necessary for a fair presentation of such amounts have been
included. The results of operations for the quarter are not necessarily
indicative of results for the year.
Reclassifications
Certain prior year statements of consolidated cash flow amounts have been
reclassified to conform with current year classifications.
Inventories
Inventories are stated at the lower of cost or market. Inventories at November
30, 1995 are comprised of the following:
<TABLE>
<S> <C>
Raw materials $ 6,169
Finished Goods 26,987
-------
$33,156
=======
</TABLE>
Item 2. MANAGEMENT'S DISCUSSION AND ANALYSIS
Summary Analysis
In this second quarter of fiscal year 1996, Diagnon realized net income of
$14,331 totalling $53,335 for the first six months of fiscal year 1996.
During this quarter, the Company's subsidiary, BIOQUAL, Inc., was awarded and
in December began work on a two year contract with the National Institute of
Allergy and Infectious Disease. The contract titled "MAO/Evaluation of AIDS
Vaccines in Non-Human Primates" totals $367,489.
During December 1995, BIOQUAL won a renewal competition and began work on the
National Cancer Institute contract titled "Mechanisms of Chemical
Carcinogenesis in Old World Monkeys". This five year contract totals
$3,266,150.
During this quarter, the Company announced that a distribution agreement had
been reached with The Butler Company to market and distribute Equine IgG as a
treatment for failure of passive transfer in equine neonates. Butler is the
largest veterinary distribution company in the U.S. with 22 service centers and
a sales force of 150 territory managers distributing product in all 50 states,
with expanding international markets under development. Butler's sales
professionals will be presenting Diagnon's Lyophilized Equine IgG technology to
the nation's 1,860 equine practitioners, veterinary colleges, veterinary
technicians and equine specialists.
Results of Operations
Three Months Comparison
For the three months of operations ended November 30, 1995 (the Company's
second quarter), Contract Revenues decreased by 10.5% compared to the prior
year primarily due to decreased contract activity (two major contracts ended
-6-
<PAGE> 8
at the end of the last fiscal year and in the first quarter of this year
respectively). Contract Operating Expenses decreased 7.6% primarily due to
decreased contract activity offset by costs incurred associated with the
production of Equine IgG which the Company intends to market and sell during
the first half of the next calendar year. General and Administrative Expenses
(G&A) decreased 14.5% compared to the prior year. During the same quarter last
year, the Company wrote off approximately $104,000 related to the termination
of the agreements between Diagnon and The Johns Hopkins University (see
November 1994 10-QSB). The decrease in G&A is the net result of the prior year
write off and an increase in current year expenses resulting from annual salary
increases and the addition of a full-time legal counsel. Total Operating
Expenses decreased 9.1% primarily due to the expiration of the two contracts
mentioned above.
Operating Income decreased 49.8% compared to the prior year primarily due to
decreased contract activity and to the costs incurred associated with the
production of Equine IgG as stated above.
For this quarter, Diagnon had interest expense of $12,341 compared to interest
expense of $9,769 in the prior year. The increase is primarily attributable to
capitalized leases at higher interest rates.
Six Months Comparison
For the six months of operations ended November 30, 1995, Contract Revenues
decreased by 10.3% compared to the prior year primarily due to decreased
contract activity. Contract Operating Expenses decreased 10.1% primarily due
to decreased contract activity offset by costs incurred associated with the
production of Equine IgG which the Company intends to market and sell during
the first half of the next calendar year. General and Administrative Expenses
decreased 5.8% primarily due to the net result of the $104,000 prior year
write-off and the salary increases and additional staff as discussed in the
Three Months Comparison. Total Operating Expenses decreased 9.3%, due to the
above.
Operating Income decreased 38.8% compared to the prior year primarily due to
decreased contract activity and to the costs incurred associated with the
production of Equine IgG as stated above.
For the six months of this fiscal year, Diagnon had interest expense of $19,986
compared to interest expense of $14,082 in the prior year. The increase is
primarily attributable to capitalized leases at higher interest rates.
Liquidity and Capital Resources
Assets
The changes in Cash and Cash Equivalents are detailed in the Statements of
Consolidated Cash Flows on page 5. Accounts Receivable have increased by
$224,667 consisting of 1) an increase of $359,432 to Unbilled Accounts
Receivable representing increases in reimbursable indirect rate variances of
$280,630 and unbilled accrued direct costs of $78,802 billed in December 1995,
2) a $141,036 decrease to Trade Receivables reflecting decreased contract
activity and a slightly faster than normal collections rate when compared to
the prior fiscal year end and 3) a $6,271 increase to a receivable from
ZooQuest Technologies LTD. Prepaid Expenses increased by
-7-
<PAGE> 9
$62,080 primarily due to the prepayment of $6,600 in life insurance premiums,
$21,100 in business insurance premiums, and $29,000 in real estate and personal
property taxes. An increase in Fixed Assets, net of Accumulated Depreciation
and Amortization of $143,578 reflects fixed asset purchases of $270,520 (mainly
nonhuman primate housing units and an autoclave) offset by depreciation and
amortization of $126,942 during this six month period. Other Noncurrent Assets
increased by $17,097 as the net result of the completion of a nonhuman primate
housing unit order from the previous fiscal year ($52,553) and a $70,000
deposit on a new order of eleven units during this quarter.
Deferred Income Taxes decreased by $24,000 primarily as a result of utilizing a
portion of the federal income tax loss carryforward.
Liabilities
In the first six months of operations, Total Liabilities increased $248,319.
This increase is primarily attributable to 1) an increase to Borrowings Under
Line-of-Credit of $223,793 necessitated by the increases in Prepaid Expenses
and Unbilled Accounts Receivable and Fixed Asset purchases as stated above, 2)
an increase in Long-Term Debt of $78,045 related to capital leases of $128,252
for nonhuman primate enclosures at the Research Boulevard Facility offset by
$50,207 of payments on capital leases, and 3) an increase in Other Accrued
Liabilities of $8,675 reflecting the accrual of an equine serum purchase for
the production of the equine IgG product.
The above increase is partially offset by a decrease in Accounts Payable of
$64,473 due to decreased contract activity.
The Company believes it has sufficient cash and financing sources to provide
for its ongoing operations and the Company continues to believe that the impact
of inflation, or the absence of it, will have no significant effect on its
operations.
PART II. Other Information
Item 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
Annual Meeting - October 11, 1995
Election of Directors
Four directors were elected:
<TABLE>
<CAPTION>
For Withheld
--------- --------
<S> <C> <C>
J. Thomas August, M.D. 3,581,609 4,900
Charles C. Francisco 3,581,809 4,700
Charles F. Gauvin 3,581,609 4,900
John C. Landon, Ph.D. 3,581,009 6,500
</TABLE>
There were no other directors whose term of office as a director continued
after the meeting.
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<PAGE> 10
Other Matters Voted Upon at the Meeting
Proposal 2 To approve the purchase by the Company of approximately
200,000 shares of the Company's stock from John C. Landon (Chairman
of the Board and CEO) at market value to fund the repayment by Dr.
Landon of the remainder of a Company loan of $90,000.
<TABLE>
<S> <C>
Affirmative Votes 2,558,652
Negative Votes 18,955
Abstain 1,001,602
</TABLE>
Proposal 3 To approve the appointment of Deloitte & Touche LLP as
independent public accountants for the Company.
<TABLE>
<S> <C>
Affirmative Votes 3,578,349
Negative Votes 4,420
Abstain 3,740
</TABLE>
Item 6. EXHIBITS
(10) (a) Government Contracts.
1. Title: MAO/Evaluation of AIDS
Vaccines in Non-Human
Primates.
Institute: National Institute of
Allergy and Infectious
Disease
Dates Funded: 9/30/95 - 11/15/97
Contract Funding: $367,489
2. Title: Mechanisms of Chemical
Carcinogenesis in Old
World Monkeys.
Institute: National Cancer
Institute
Dates Funded: 12/19/95 - 12/18/00
Contract Funding: $3,266,150
-9-
<PAGE> 11
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused the report to be signed on its behalf by the
undersigned thereunto duly authorized.
DIAGNON CORPORATION
DATE January 12, 1996 /s/ John C. Landon, Ph.D.
-------------------- --------------------------------
Chairman of the Board,
President and Chief Executive
Officer
DATE January 12, 1996 /s/ Michael P. O'Flaherty
-------------------- --------------------------------
Chief Operating Officer and
Secretary
DATE January 12, 1996 /s/ David A. Newcomer
-------------------- --------------------------------
Chief Financial Officer
-10-
<PAGE> 12
EXHIBIT INDEX
(10)(a) GOVERNMENT CONTRACTS
1. MAO/Evaluation of AIDS Vaccines in Non-Human Primates.
2. Mechanisms of Chemical Carcinogenesis on Old World Monkeys.
<PAGE> 1
(10) (a) GOVERNMENT CONTRACTS
1. MAO/Evaluation of AIDS Vaccines in Non-Human Primates.
<PAGE> 2
STANDARD FORM 26 (REV. 4-85) NSN 0-01-152-8069 OMB No. 0990-0115 RFP 95-20
- --------------------------------------------------------------------------------
AWARD/CONTRACT
- --------------------------------------------------------------------------------
1. THIS CONTRACT IS A RATED ORDER RATING PAGE OF PAGES
UNDER DPAS (15 CFR 350) 1 12
- --------------------------------------------------------------------------------
2. CONTRACT (Proc. inst. ident.) No.
N01-AI-55276
- --------------------------------------------------------------------------------
3. EFFECTIVE DATE
September 30, 1995
- --------------------------------------------------------------------------------
4. REQUISITION/PURCHASE REQUEST/PROJECT NO.
000911
- --------------------------------------------------------------------------------
5. ISSUED BY CODE 2668-55276
National Institutes of Health
Contract Management Branch, NIAID
Solar Building, Room 3C07
6003 Executive Boulevard MSC 7610
Bethesda, Maryland 20892-7610
- --------------------------------------------------------------------------------
6. ADMINISTERED BY (If other than item 5) CODE
- --------------------------------------------------------------------------------
7. NAME AND ADDRESS OF CONTRACTOR (No., street, city, county, State and ZIP
Code)
Bioqual, Inc.
2501 Research Boulevard
Rockville, MD 20850
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CODE FACILITY CODE
- --------------------------------------------------------------------------------
8. DELIVERY Destination
/ / FOB ORIGIN /X/ OTHER (See below)
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9. DISCOUNT FOR PROMPT DELIVERY
N/A
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10. SUBMIT INVOICES ITEM
(4 copies unless other-
wise specified) TO THE G.3
ADDRESS SHOWN IN
- --------------------------------------------------------------------------------
11. SHIP TO/MARK FOR
See Article F.1
- --------------------------------------------------------------------------------
12. PAYMENT WILL BE MADE BY CODE
See Article G.3
- --------------------------------------------------------------------------------
13. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION
N/A
/ / 10 U.S.C. 2304 (c) ( ) / / 41 U.S.C. 253(c) ( )
- --------------------------------------------------------------------------------
14. ACCOUNTING AND APPROPRIATION DATA
EIN# 1-521244771A1 CAN# 58425674
DOC# 300N1AI55276A SOC# 25.55
FY1995 Funds Allotted: $201,819
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<TABLE>
<CAPTION>
- -----------------------------------------------------------------------------------------------------------------------------
15A. ITEM NO. 15B. SUPPLIES/SERVICES 15C. QUANTITY 15D. UNIT 15E. UNIT PRICE 15F. AMOUNT
- ------------- ---------------------- ------------- --------- --------------- -----------
<S> <C>
Research & Development Contract-Awd. under MAN01-AI-42603 FY 95 201,819
Title: MAO/Evaluation of AIDS Vaccines in Non-Human Primate FY 96 146,283
Period: September 30, 1995 through November 15, 1997 FY 97 19,387
Amount allotted: $ 201,819
Contract Type: Cost Reimbursement/Completion
- -----------------------------------------------------------------------------------------------------------------------------
15G. TOTAL AMOUNT OF CONTRACT $ 367,489
- -----------------------------------------------------------------------------------------------------------------------------
</TABLE>
<TABLE>
<CAPTION>
16. TABLE OF CONTENTS
- --------------------------------------------------------------------------------
(X) SEC. DESCRIPTION PAGE(S)
- --------------------------------------------------------------------------------
<C> <C> <S> <C>
PART I - THE SCHEDULE
X A SOLICITATION/CONTRACT FORM 1
X B SUPPLIES OR SERVICES AND PRICES/COST 3
X C DESCRIPTION/SPECS./WORK STATEMENT 6
X D PACKAGING AND MARKING 7
X E INSPECTION AND ACCEPTANCE 7
X F DELIVERIES OR PERFORMANCE 7
X G CONTRACT ADMINISTRATION DATA 8
X H SPECIAL CONTRACT REQUIREMENTS 9
PART II - CONTRACT CLAUSES
X I CONTRACT CLAUSES 10
PART III - LIST OF DOCUMENTS, EXHIBITS AND
OTHER ATTACH.
X J LIST OF ATTACHMENTS 11
PART IV - REPRESENTATIONS AND INSTRUCTIONS
X K REPRESENTATIONS, CERTIFICATIONS AND
OTHER STATEMENTS OF OFFERORS 12
L INSTRS., CONDS., AND NOTICES TO OFFERORS
M EVALUATION FACTORS FOR AWARD
</TABLE>
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CONTRACTING OFFICER WILL COMPLETE ITEM 17 OR 18 AS APPLICABLE
- --------------------------------------------------------------------------------
17. /X/ CONTRACTOR'S NEGOTIATED AGREEMENT (Contractor is required to sign this
document and return 3 copies to issuing office.) Contractor agrees to
furnish and deliver all items or perform all the services set forth or otherwise
identified above and on any continuation sheets for the consideration stated
herein. The rights and obligations of the parties to this contract shall be
subject to and governed by the following documents: (a) this award/contract,
(b) the solicitation, if any, and (c) such provisions, representations,
certifications, and specifications, as are attached or incorporated by
reference herein. (Attachments are listed herein.)
- --------------------------------------------------------------------------------
18. / / AWARD (Contractor is not required to sign this document.) Your offer on
Solicitation Number _______________________ including the full additions or
changes made by you which additions or changes are set forth in full above, is
hereby accepted as to the items listed above and on any continuation sheets.
This award consummates the contract which consists of the following documents:
(a) the Government's solicitation and your offer, and (b) this award/contract.
No further contractual document is necessary.
- --------------------------------------------------------------------------------
19A. NAME AND TITLE OF SIGNER (Type or print)
Michael P. O'Flaherty COO
- --------------------------------------------------------------------------------
19B. NAME OF CONTRACTOR 19C. DATE SIGNED
BY /s/ MICHAEL P. O'FLAHERTY 9/22/95
----------------------------------------
(Signature of person authorized to sign)
- --------------------------------------------------------------------------------
20A. NAME OF CONTRACTING OFFICER
Lawrence M. Butler, Contracting Officer
AIDS Preclinical Research Contract Section, CMB, NIAID, NIH
- --------------------------------------------------------------------------------
20B. UNITED STATES OF AMERICA 20C. DATE SIGNED
BY /s/ LAWRENCE M. BUTLER 9/22/95
----------------------------------------
(Signature of Contracting Officer)
- --------------------------------------------------------------------------------
<PAGE> 3
DETAILED TABLE OF MASTER AGREEMENT ORDER (MAO) CONTENTS
<TABLE>
<S> <C>
PART I - THE SCHEDULE
SECTION A - SOLICITATION/CONTRACT FORM . . . . . . . . . . . . . . . 1
SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS . . . . . . . . . 3
ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES . . . . 3
ARTICLE B.2. ESTIMATED COST AND FIXED FEE . . . . . . . . . . . 3
ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS . . . . . . 3
ARTICLE B.4. ADVANCE UNDERSTANDINGS . . . . . . . . . . . . . . 5
SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT . . . . . . . 6
ARTICLE C.1. STATEMENT OF WORK . . . . . . . . . . . . . . . . 6
ARTICLE C.2. REPORTING REQUIREMENTS . . . . . . . . . . . . . . 6
SECTION D - PACKAGING, MARKING AND SHIPPING . . . . . . . . . . . . 7
SECTION E - INSPECTION AND ACCEPTANCE . . . . . . . . . . . . . . . 7
SECTION F - DELIVERIES OR PERFORMANCE . . . . . . . . . . . . . . . 7
ARTICLE F.1. DELIVERIES . . . . . . . . . . . . . . . . . . . . 7
ARTICLE F.2. STOP WORK ORDER . . . . . . . . . . . . . . . . . 8
SECTION G - MASTER AGREEMENT ORDER ADMINISTRATION DATA . . . . . . . 8
ARTICLE G.1. PROJECT OFFICER . . . . . . . . . . . . . . . . . 8
ARTICLE G.2. KEY PERSONNEL . . . . . . . . . . . . . . . . . . 8
ARTICLE G.3. INVOICE SUBMISSION . . . . . . . . . . . . . . . . 9
ARTICLE G.4. GOVERNMENT PROPERTY . . . . . . . . . . . . . . . 9
ARTICLE G.5. GOVERNMENT SUPPLY SOURCES . . . . . . . . . . . . 9
SECTION H - SPECIAL MASTER AGREEMENT ORDER REQUIREMENTS . . . . . . 9
ARTICLE H.1. ANIMAL WELFARE ASSURANCE . . . . . . . . . . . . . 9
ARTICLE H.2. HUMAN SUBJECTS . . . . . . . . . . . . . . . . . . 9
ARTICLE H.3. SALARY RATE LIMITATION LEGISLATION PROVISIONS . . 9
PART II . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
SECTION I - MASTER AGREEMENT ORDER CLAUSES . . . . . . . . . . . . . 10
ARTICLE I.1. GENERAL CLAUSES FOR A COST-REIMBURSEMENT RESEARCH
AND DEVELOPMENT MASTER AGREEMENT ORDER . . . . . . . . . . 10
ARTICLE I.2. AUTHORIZED SUBSTITUTIONS OF CLAUSES . . . . . . . 10
ARTICLE I.3. ADDITIONAL MAO CLAUSES . . . . . . . . . . . . . . 10
ARTICLE I.4. ADDITIONAL FAR CLAUSES INCLUDED IN FULL TEXT . . . 10
PART III . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
SECTION J - LIST OF ATTACHMENTS . . . . . . . . . . . . . . . . . . 11
Statement of Work . . . . . . . . . . . . . . . . . . . . . . . 11
Invoice/Financing Request Instructions for NIH
Cost-Reimbursement Type Contracts . . . . . . . . . . . . . . 11
Safety and Health . . . . . . . . . . . . . . . . . . . . . . . 11
Procurement of Certain Equipment . . . . . . . . . . . . . . . 11
PART IV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
SECTION K - REPRESENTATIONS AND CERTIFICATIONS . . . . . . . . . . . 12
Representations and Certifications . . . . . . . . . . . . . . 12
Animal Welfare Assurance Number A3530-01 . . . . . . . . . . . 12
</TABLE>
<PAGE> 4
SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS
[THIS MAO IS AWARDED UNDER MASTER AGREEMENT NO1-AI-42603 FOR HIV
PRECLINICAL VACCINE DEVELOPMENT]
ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES
The purpose of this master agreement order (MAO) is to study the Immunogenicity
of a Soluble Oligomeric Form of the HIV-1 Envelope Protein (Vaccine Study #13
under Category B RFP NIH-NIAID-DAIDS-95-20).
ARTICLE B.2. ESTIMATED COST AND FIXED FEE
a. The estimated cost of this MAO is $343,769.
b. The fixed fee for this MAO is $23,720. The fixed fee shall be paid in
installments based on the percentage of completion of work, as determined
by the Contracting Officer, and subject to 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 MAO. Payment of fixed
fee shall not be made in less than monthly installments.
C. The Government's obligation, represented by the sum of the estimated cost
plus fixed fee, is $367,489.
d. Total funds currently available for payment and allotted to this MAO are
$201,819 of which $188,792 represents the estimated costs, and of which
$13,027 represents the fixed fee. For further provisions on funding see
the LIMITATION OF FUNDS clause referenced in Part II, ARTICLE 1.2.
Authorized Substitutions of Clauses of this Master Agreement Order (MAO).
e. It is estimated that the amount currently allotted will cover performance
of the MAO through September 29, 1996.
f. The negotiated costs for the contract period are:
<TABLE>
<CAPTION>
Estimated Fixed Total Estimated
Period Cost Fee Cost Plus Fee
<S> <C> <C> <C>
09/30/95 - 09/29/96 $ 188,792 $ 13,027 $ 201,819
09/30/96 - 09/29/97 $ 136,840 $ 9,442 $ 146,283
09/30/97 - 11/15/98 $ 18,136 $ 1,251 $ 19,387
--------- -------- ---------
Total $ 343,769 $ 23,720 $ 367,489
</TABLE>
ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS
a. Items Unallowable Unless Otherwise Provided
Notwithstanding the clause(s), ALLOWABLE COST AND PAYMENT, [and FIXED
FEE,] incorporated in this MAO, UNLESS AUTHORIZED IN WRITING BY THE
CONTRACTING OFFICER, the costs of the following items or activities shall
be UNALLOWABLE as direct costs:
(1) Acquisition, by purchase or lease, of any interest in real property;
(2) Special rearrangement or alteration of facilities;
3
<PAGE> 5
(3) Purchase or lease of an item of general purpose office furniture or
office equipment regardless of dollar value. (General purpose
equipment is defined as any items of personal property which are
usable for purposes other than research, such as office equipment
and furnishings, pocket calculators, etc.);
(4) Travel to attend general scientific meetings (a general scientific
meeting is defined as an assemblage of scientific/technical personnel
held to exchange information and ideas through a scheduled program of
presentations; includes conferences, congresses, seminars, symposia
and workshops; usually sponsored by a national organization);
(5) Foreign travel - See Paragraph b. below;
(6) Overtime premium;
(7) Consultant fees;
(8) Subcontracts;
(9) Accountable Government property (defined as both real and personal
property with an acquisition cost of $1,000 or more and a life
expectancy of more than two years) and "sensitive items" (defined and
listed in the Contractor's Guide for Control of Government Property,
1990, regardless of acquisition value).
b. Travel Costs
(1) Domestic Travel
(a) Total expenditures for domestic travel (transportation, lodging,
subsistence, and incidental expenses) incurred in direct
performance of this MAO shall not exceed $-0- without the prior
written approval of the Contracting Officer.
(DOMESTIC TRAVEL is defined as MAO Holder travel directly
applicable to performance under this MAO; includes travel to
discuss progress under this MAO with the Project Officer or
Contracting Officer or to attend meetings, called by the NIAID,
of collaborating program investigators to discuss program
progress and plans. The domestic travel amount above does not
include scientific meeting travel which is defined in Article
B.3.a. above and which shall be specifically approved in writing
by the Contracting Officer.)
(b) The cost of travel by privately-owned automobile shall be
reimbursed at the mileage rate prescribed by the MAO Holder's
established, generally applicable travel policy in lieu of
actual costs, provided, however, that such reimbursement shall
not exceed the otherwise allowable comparative cost of travel
by common carrier.
(c) Reasonable actual costs of lodging and subsistence, or per diem
in lieu of actual costs, shall be allowable to the extent that
such actual costs or per diem amounts do not exceed the amounts
or per diem rates prescribed by the MAO Holder's established,
generally applicable travel policy.
(d) Any revision to the MAO Holder's established, generally
applicable travel policy submitted to the cognizant audit
agency during the period of performance of this MAO shall be
effective, without formal modification to this MAO, upon
delivery to the Contracting Officer of notice describing such
revised policy together with evidence of submission thereof to
the cognizant audit agency.
(2) Foreign Travel
Requests for foreign travel must be submitted at least six
weeks in advance and shall contain the following: (a) meeting(s) and
place(s) to be visited, with costs and dates; (b) name(s) and
title(s) of Master Agreement Holder's personnel to travel and their
functions in the specific Master Agreement Order project; (c) the
Master Agreement Order purposes to be served by the travel; (d) how
travel of Master Agreement Order personnel will benefit and
contribute to accomplishing the specific Master Agreement Order
project, or will otherwise justify the expenditure of NIH Master
Agreement Order funds; (e) how such advantages justify the costs for
travel and absence from the project
4
<PAGE> 6
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 specific Master Agreement Order and thus further
benefit the project.
ARTICLE B.4. ADVANCE UNDERSTANDINGS
Other provisions of this MAO notwithstanding, approval of the following items
within the limits set forth is hereby granted without further authorization
from the Contracting Officer.
a. The estimated level of effort set forth below is for guidance to serve not
as a measure of the MAO Holder's obligation but as a further description
of the required tasks. It will represent the basis of direct labor agreed
to in the MAO negotiations for the period from September 30, 1995 through
November 15, 1997, and will be used by both the Government and the MAO
Holder to monitor progress toward achievement of the MAO objectives.
<TABLE>
<CAPTION>
Total Estimated
Labor Category Number of Hours
-------------- ---------------
<S> <C>
Principal Investigator 208
Other Professional Staff 99
Technical Staff 3,278
-----
TOTAL 3,585
</TABLE>
b. The MAO Holder agrees to abide by the terms of FAR 52.247-63, Preference
for U.S.-Flag Air Carriers. This provision states in part that, in
performing work under this MAO, the MAO Holder shall utilize U.S. flag air
carriers unless service by those carriers is not available. If U.S. flag
air carriers are not available the MAO Holder shall so certify in writing
and include that certification/justification in the request for advance
approval of foreign travel. (Cost/lower fares are not acceptable reasons
for proposing to utilize foreign air carriers.)
c. If the MAO contains any specific limitations/ceilings on particular costs,
these shall always prevail until modified in the MAO.
d. The MAO Holder agrees that samples/products received from/through the
Government for utilization under this MAO shall be used only for purposes
required by this MAO.
e. Publication of Manuscripts or Abstracts
Because there is a likelihood that the MAO Holder will be evaluating
proprietary compounds provided to the Government by a third party, it is
essential to include provisions that will protect the rights of the third
party suppliers as follows:
The MAO Holder agrees that manuscripts/abstracts based on
data/information generated under this MAO will not be submitted for
publication until written Project Officer clearance has been
received. MAO support shall be acknowledged in all such
publications. (Refer to Attachment 1, Work Statement, Item Number
11.C.) A "publication" is defined as an issue of printed material
offered for distribution or any communication or oral presentation of
information.
The Project Officer will review all manuscripts/documents in a period
of time not to exceed 30 calendar days from receipt, and will either
grant clearance for publication/disclosure, recommend changes or, as
applicable, refer the document to the Supplier of the compound for
their review.
NIAID will use its best efforts to assist and expedite the review
process by the Supplier wherever possible.
5
<PAGE> 7
f. Correspondence Procedures
To promote timely and effective administration, correspondence (except for
invoices/financial reports, technical progress reports/other deliverables)
submitted under this MAO shall be subject to the following procedures:
1. TECHNICAL CORRESPONDENCE shall be addressed to the Project Officer
with an information copy of the basic correspondence to the
Contracting Officer. (As used herein, technical correspondence
excludes correspondence which proposes deviations from or
modifications of MAO requirements, terms or conditions.)
2. OTHER CORRESPONDENCE shall be addressed to the Contracting Officer,
with an information copy of the basic correspondence to the Project
Officer.
3. Subject Line(s). All correspondence shall contain a subject line
commencing with the MAO number as illustrated below:
SUBJECT: MAO No. NO1-AI-55276
REQUEST FOR APPROVAL OF
SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT
ARTICLE C.1. STATEMENT OF WORK
a. Independently and not as an agent of the Government, the MAO Holder 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
September 30, 1995, attached hereto and incorporated herein.
ARTICLE C.2. REPORTING REQUIREMENTS
a. Technical Reports
In addition to those reports required by the other terms of this MAO, the
MAO Holder shall prepare and submit the following reports in the manner
stated below and in accordance with ARTICLE F.1. DELIVERIES of this MAO:
(1) Quarterly Progress Report
This report shall include a (description of the activities during the
reporting period, and the activities planned for the ensuing
reporting period. - OR - summation of the monthly progress reports.)
The first reporting period consists of the first full three months of
performance including any fractional part of the initial month.
Thereafter, the reporting period shall consist of three full calendar
months. A quarterly report shall not be submitted when a final
report is due.
(2) Final Report
The MAO Holder shall submit five (5) copies of the final report
documents. Four (4) copies shall be submitted to the Project Officer
and (1) copy shall be submitted to the Contracting Officer. This
report is to include a summation of the work performed and results
obtained for the entire MAO period of performance. This report shall
be in sufficient detail to describe comprehensively the results
achieved. The Final Report shall be submitted no later than the
completion date of this MAO.
6
<PAGE> 8
SECTION D - PACKAGING, MARKING AND SHIPPING
All deliverables required under this MAO shall be packaged, marked and shipped
in accordance with Government specifications. The MAO Holder shall guarantee
that all required materials shall be delivered in immediate usable and
acceptable condition.
SECTION E - INSPECTION AND ACCEPTANCE
a. For the purpose of this ARTICLE, the designated Project Officer is the
authorized representative of the Contracting Officer, who shall perform
inspection and acceptance of materials and services to be provided.
b. Inspection and acceptance will be performed at the Project Officer's
address listed in the clause entitled "Deliveries" in Section F.
Acceptance may be presumed unless otherwise indicated in writing by the
Contracting Officer or the duly authorized representative within 30 days
of receipt.
C. This MAO 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 52.246-9, INSPECTION OF RESEARCH AND DEVELOPMENT - (SHORT
FORM)(APRIL 1984).
SECTION F - DELIVERIES OR PERFORMANCE
ARTICLE F.1. DELIVERIES
Satisfactory performance of this MAO shall be deemed to occur upon delivery and
acceptance by the Contracting Officer, or the duly authorized representative,
of the following items in accordance with the stated delivery schedule:
The items specified below as described in (SECTION C, ARTICLE C.2. shall be
delivered f.o.b. destination as set forth in FAR 52.247-35, F.O.B. DESTINATION,
WITHIN CONSIGNEES PREMISES (APRIL 1984), and in accordance with and by the
date(s) specified below [and any specifications stated in SECTION D. PACKAGING,
MARKING AND SHIPPING, of this MAO]:
<TABLE>
<CAPTION>
Item Description Quantity Delivery Schedule
---- ----------- --------- -----------------
<S> <C> <C> <C>
a. Quarterly 5 01/12/96, 97
04/12/96, 97
07/12/96, 97
10/12/96
b. Final 5 11/15/97
</TABLE>
7
<PAGE> 9
The above items shall be addressed and delivered to:
<TABLE>
<CAPTION>
Addressee Deliverable Item No. Quantity
--------- -------------------- --------
<S> <C> <C>
Project Officer a. 4
PRB, DAIDS b. 4
Solar Bldg., Rm. 2A38
6003 Executive Blvd.
Bethesda, MD. 20892
Contracting Officer a. 1
CMB, DEA, NIAID, NIH b. 1
Solar Bldg., Rm. 3C07
6003 Executive Blvd.
Bethesda, MD. 20892
</TABLE>
ARTICLE F.2. STOP WORK ORDER
This MAO 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 lull text available.
FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:
52.212-13, STOP WORK ORDER (AUGUST 1989) with ALTERNATE I (APRIL 1984).
SECTION G - MASTER AGREEMENT ORDER ADMINISTRATION DATA
ARTICLE G.1. PROJECT OFFICER
Pursuant to the Project Officer Article incorporated in the MA, the following
Project Officers will represent the Government for the purpose of this MAO:
MAO Project Officer Nancy Miller, Ph.D.
MAO Assistant Project Officer Marta Glass, M.S.
ARTICLE G.2. KEY PERSONNEL
Pursuant to the Key Personnel clause incorporated in the MA, the following
individuals are considered to be essential to the work being performed
hereunder:
<TABLE>
<CAPTION>
NAME TITLE
---- -----
<S> <C>
Richard P. Bradbury, D.V.M. Principal Investigator
</TABLE>
8
<PAGE> 10
ARTICLE G.3. INVOICE SUBMISSION
a. INVOICE SUBMISSION - COST-REIMBURSEMENT MAOs
The Invoice/Financing Request Instructions for NIH Cost-Reimbursement Type
Contracts, NIH(RC)-1, set forth in your Master Agreement are incorporated
herein.
The invoice instructions and directions for the submission of
invoice/financing requests contained in the MA must be followed to meet
the requirements of a "proper" invoice, pursuant to FAR 32.9.
ARTICLE G.4. GOVERNMENT PROPERTY
a. In addition to the requirements of the clause, GOVERNMENT PROPERTY,
incorporated in this Section I of this MAO, the MAO Holder shall comply
with the provisions of DHHS Publication, Contractor's Guide for Control of
Government Property, (1990), which is incorporated into this MAO by
reference. Among other issues, this publication provides a summary of the
MAO Holder's responsibilities regarding purchasing authorizations and
inventory and reporting requirements under the MAO. A copy of this
publication is available upon request to the Contract Property
Administrator at the following address:
Contracts Property Administrator
Research Contracts Property Administration, NIH
Building 13, Room 2E-65
9000 Rockville Pike
Bethesda, Maryland 20892
(301) 496-6466
ARTICLE G.5. GOVERNMENT SUPPLY SOURCES, is hereby incorporated into this MAO by
reference pursuant to the Master Agreement.
SECTION H - SPECIAL MASTER AGREEMENT ORDER REQUIREMENTS
The following Articles are incorporated into this MAO by reference pursuant to
the Master Agreement. [(Any MAO Articles which are not contained in the MA are
set forth below in full text)]:
a. ARTICLE H.1. ANIMAL WELFARE ASSURANCE
b. ARTICLE H.2. HUMAN SUBJECTS
c. ARTICLE H.3. SALARY RATE LIMITATION LEGISLATION PROVISIONS
Paragraph b. of this ARTICLE is revised as follows:
<TABLE>
<CAPTION>
b. Public Law No. Fiscal Year Salary Limitation
-------------- ----------- -----------------
<S> <C> <C>
103-333 1995 $125,000
</TABLE>
9
<PAGE> 11
PART II
SECTION I - MASTER AGREEMENT ORDER CLAUSES
The following Articles are incorporated into this MAO by reference pursuant to
the Master Agreement. [(Any MAO Articles which are not contained in the MA are
set forth below in full text)]:
a. ARTICLE I.1. GENERAL CLAUSES FOR A COST-REIMBURSEMENT RESEARCH AND
DEVELOPMENT MASTER AGREEMENT ORDER
b. ARTICLE I.2. AUTHORIZED SUBSTITUTIONS OF CLAUSES, [Cost-Reimbursement]
C. ARTICLE I.3. ADDITIONAL MAO CLAUSES, [Cost-Reimbursement]
d. ARTICLE I.4. ADDITIONAL FAR CLAUSES INCLUDED IN FULL TEXT
10
<PAGE> 12
PART III
SECTION J - LIST OF ATTACHMENTS
Unless otherwise indicated below, the following documents are attached and
incorporated in this MAO:
1. Statement of Work, September 30, 1995, 4 pages.
2. Invoice/Financing Request Instructions for NIH Cost-Reimbursement Type
Contracts, NIH(RC)-1 (6/18/92), 4 pages. [This attachment is part of the
Master Agreement document and is incorporated into this MAO by reference.]
3. Safety and Health, PHSAR Clause 352.223-70, (4/84), 2 pages. [This
attachment is part of the Master Agreement document and is incorporated
into this MAO by reference.]
4. Procurement of Certain Equipment, NIH(RC)-7, (4/1/84), 1 page. [This
attachment is part of the Master Agreement document and is incorporated
into this MAO by reference.]
11
<PAGE> 13
PART IV
SECTION K - REPRESENTATIONS AND CERTIFICATIONS
The following documents are incorporated by reference in this MAO:
1. Representations and Certifications, dated March 14, 1995.
2. Animal Welfare Assurance Number A3530-01.
END of the SCHEDULE
(MASTER AGREEMENT ORDER)
12
<PAGE> 1
(10) (a) GOVERNMENT CONTRACTS
2. Mechanisms of Chemical Carcinogenesis in Old World Monkeys.
<PAGE> 2
OMB NO. 0990-0115
================================================================================
AWARD/CONTRACT
- --------------------------------------------------------------------------------
1. THIS CONTRACT IS A RATED ORDER RATING PAGE OF PAGES
UNDER DPAS (15 CFR 350) 1 28
- --------------------------------------------------------------------------------
2. CONTRACT (Proc. Inst. Ident.) NO.
N01-CP-62601
- --------------------------------------------------------------------------------
3. EFFECTIVE DATE
12/19/95
- --------------------------------------------------------------------------------
4. REQUISITION PURCHASE REQUEST/PROJECT NO.
328135
- --------------------------------------------------------------------------------
5. ISSUED BY CODE 261962601
National Cancer Institute
Research Contracts Branch, CECS
Executive Plaza South, Room 620
6120 EXECUTIVE BLVD MSC 7224
BETHESDA MARYLAND 20892-7224
- --------------------------------------------------------------------------------
6. ADMINISTERED BY (If other than item 5) CODE
LAB OF COMPARATIVE CARCINOGENESIS
CHEMICAL AND PHYSICAL CARCINOGENESIS PROGRAM
DIVISION OF CANCER ETIOLOGY
(RFP No. NCI-CP-62601-13)
- --------------------------------------------------------------------------------
7. NAME AND ADDRESS OF CONTRACTOR (No., street, city, county, State and ZIP
Code)
BIOQUAL, INC.
9600 MEDICAL CENTER DRIVE
ROCKVILLE, MARYLAND 20850-3300
PLACE OF PERFORMANCE: ROCKVILLE, MARYLAND
- --------------------------------------------------------------------------------
CODE FACILITY CODE
- --------------------------------------------------------------------------------
8. DELIVERY
/ / FOB ORIGIN /X/ FOB DESTINATION
- --------------------------------------------------------------------------------
9. DISCOUNT FOR PROMPT DELIVERY
- --------------------------------------------------------------------------------
10. SUBMIT INVOICES ITEM
(4 copies unless other- SEE SECTION G
wise specified) TO ARTICLE G.3.
THE ADDRESS SHOWN IN:
- --------------------------------------------------------------------------------
11. SHIP TO/MARK FOR CODE
SEE SECTION F, ARTICLE F.1.
- --------------------------------------------------------------------------------
12. PAYMENT WILL BE MADE BY CODE
SEE SECTION G, ARTICLE G.3.
- --------------------------------------------------------------------------------
13. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION
/ / 10 U.S.C. 2304(c) ( ) / / 41 U.S.C. 253(c) ( )
- --------------------------------------------------------------------------------
14. ACCOUNTING AND APPROPRIATION DATA
CAN1 68332731 TIN 1521244771A1
-------- ------------
CAN2 DOC NO. N1CP62601A
-------- ------------
OC CODE 25.2E LOC
-------- ------------
- --------------------------------------------------------------------------------
<TABLE>
<CAPTION>
- -----------------------------------------------------------------------------------------------------------------------------
15A. ITEM NO. 15B. SUPPLIES/SERVICES 15C. QUANTITY 15D. UNIT 15E. UNIT PRICE 15F. AMOUNT
- ------------- ---------------------- ------------- --------- --------------- -----------
<S> <C>
TITLE: MECHANISMS OF CHEMICAL CARCINOGENESIS
IN OLD WORLD MONKEYS
CONTRACT PERIOD: 12/19/95 through 12/18/00
CONTRACT TYPE: Cost_Plus Fixed Fee, COMPLETION
CURRENT OBLIGATION: $ 597,666
- -----------------------------------------------------------------------------------------------------------------------------
15G. TOTAL AMOUNT OF CONTRACT $ 3,266,150
- -----------------------------------------------------------------------------------------------------------------------------
</TABLE>
<TABLE>
<CAPTION>
16. TABLE OF CONTENTS
- --------------------------------------------------------------------------------
(X) SEC. DESCRIPTION PAGE(S)
- --------------------------------------------------------------------------------
<C> <C> <S> <C>
PART I - THE SCHEDULE
X A SOLICITATION/CONTRACT FORM 1
X B SUPPLIES OR SERVICES AND PRICES/COST 4
X C DESCRIPTION/SPECS./WORK STATEMENT 5
X D PACKAGING AND MARKING 7
X E INSPECTION AND ACCEPTANCE 7
X F DELIVERIES OR PERFORMANCE 7
X G CONTRACT ADMINISTRATION DATA 9
X H SPECIAL CONTRACT REQUIREMENTS 12
PART II - CONTRACT CLAUSES
X I CONTRACT CLAUSES 14
PART III - LIST OF DOCUMENTS, EXHIBITS AND
OTHER ATTACH.
X J LIST OF ATTACHMENTS 27
PART IV - REPRESENTATIONS AND INSTRUCTIONS
X K REPRESENTATIONS, CERTIFICATIONS AND
OTHER STATEMENTS OF OFFERORS 28
L INSTR., CONDS., AND NOTICES TO OFFERORS
M EVALUATION FACTORS FOR AWARD
</TABLE>
- --------------------------------------------------------------------------------
CONTRACTING OFFICER WILL COMPLETE ITEM 17 OR 18 AS APPLICABLE
- --------------------------------------------------------------------------------
17. /X/ CONTRACTOR'S NEGOTIATED AGREEMENT (Contractor is required to sign this
document and return 1 copies to issuing office.) Contractor agrees to
furnish and deliver all items or perform all the services set forth or otherwise
identified above and on any continuation sheets for the consideration stated
herein. The rights and obligations of the parties to this contract shall be
subject to and governed by the following documents: (a) this award/contract,
(b) the solicitation, if any, and (c) such provisions, representations,
certifications, and specifications, as are attached or incorporated by
reference herein. (Attachments are listed herein.)
- --------------------------------------------------------------------------------
18. / / AWARD (Contractor is not required to sign this document.) Your offer on
Solicitation Number _______________________, including the additions or changes
made by you which additions or changes are set forth in full above, is hereby
accepted as to the items listed above and on any continuation sheets. This award
consummates the contract which consists of the following documents: (a) the
Government's solicitation and your offer, and (b) this award/contract. No
further contractual document is necessary.
- --------------------------------------------------------------------------------
19A. NAME AND TITLE OF SIGNER (Type or print)
Michael P. O'Flaherty COO
- --------------------------------------------------------------------------------
19B. NAME OF CONTRACTOR 19C. DATE SIGNED
BY /s/ MICHAEL P. O'FLAHERTY 12/13/95
----------------------------------------
(Signature of person authorized to sign)
- --------------------------------------------------------------------------------
20A. NAME OF CONTRACTING OFFICER
SHARON A. MILLER
- --------------------------------------------------------------------------------
20B. UNITED STATES OF AMERICA 20C. DATE SIGNED
BY /s/ SHARON A. MILLER 12/13/95
----------------------------------------
(Signature of Contracting Officer)
- --------------------------------------------------------------------------------
<TABLE>
<S> <C> <C>
NSN 7540-01-152-8069 26-107 STANDARD FORM 26 (REV. 4-85)
PREVIOUS EDITION UNUSABLE Prescribed by GSA
* GPO : 1985 O - 461-275 (418) FAR (48 CFR) 53.214(a)
</TABLE>
<PAGE> 3
Contract No. NO1-CP-62601
DETAILED TABLE OF CONTRACT CONTENTS
<TABLE>
<S> <C>
PART I - THE SCHEDULE
SECTION A - SOLICITATION/CONTRACT FORM . . . . . . . . . . . . . . . . . . . 1
SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS . . . . . . . . . . . . . 4
ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES . . . . . . . . 4
ARTICLE B.2. ESTIMATED COST AND FIXED FEE . . . . . . . . . . . . . . . 4
ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS . . . . . . . . . . 4
ARTICLE B.4. ADVANCE UNDERSTANDINGS . . . . . . . . . . . . . . . . . . 5
SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT . . . . . . . . . . . 5
ARTICLE C.1. STATEMENT OF WORK . . . . . . . . . . . . . . . . . . . . 5
ARTICLE C.2. REPORTING REQUIREMENTS . . . . . . . . . . . . . . . . . . 6
SECTION D - PACKAGING, MARKING AND SHIPPING . . . . . . . . . . . . . . . . 7
ARTICLE D.1. PACKAGING . . . . . . . . . . . . . . . . . . . . . . . . 7
ARTICLE D.2. MARKING . . . . . . . . . . . . . . . . . . . . . . . . . 7
ARTICLE D.3. SHIPPING . . . . . . . . . . . . . . . . . . . . . . . . . 7
SECTION E - INSPECTION AND ACCEPTANCE . . . . . . . . . . . . . . . . . . . 7
SECTION F - DELIVERIES OR PERFORMANCE . . . . . . . . . . . . . . . . . . . 7
ARTICLE F.1. DELIVERIES . . . . . . . . . . . . . . . . . . . . . . . . 7
ARTICLE F.2. STOP WORK ORDER . . . . . . . . . . . . . . . . . . . . . 9
SECTION G - CONTRACT ADMINISTRATION DATA . . . . . . . . . . . . . . . . . . 9
ARTICLE G.1. PROJECT OFFICER . . . . . . . . . . . . . . . . . . . . . 9
ARTICLE G.2. KEY PERSONNEL . . . . . . . . . . . . . . . . . . . . . . 9
ARTICLE G.3. INVOICE SUBMISSION . . . . . . . . . . . . . . . . . . . 10
ARTICLE G.4. CONTRACT FINANCIAL REPORT . . . . . . . . . . . . . . . . 10
ARTICLE G.5. INDIRECT COST RATES . . . . . . . . . . . . . . . . . . . 11
ARTICLE G.6. GOVERNMENT PROPERTY . . . . . . . . . . . . . . . . . . . 11
ARTICLE G.7. GOVERNMENT SUPPLY SOURCES . . . . . . . . . . . . . . . . 12
SECTION H - SPECIAL CONTRACT REQUIREMENTS . . . . . . . . . . . . . . . . . 12
ARTICLE H.1. REIMBURSEMENT OF COSTS FOR INDEPENDENT RESEARCH AND
DEVELOPMENT PROJECTS . . . . . . . . . . . . . . . . . . . . . . . 12
ARTICLE H.2. HUMAN SUBJECTS . . . . . . . . . . . . . . . . . . . . . . 13
ARTICLE H.3. ANIMAL WELFARE ASSURANCE . . . . . . . . . . . . . . . . . 13
ARTICLE H.4. SALARY RATE LIMITATION LEGISLATION PROVISIONS . . . . . . 13
ARTICLE H.5. PUBLICATION AND PUBLICITY . . . . . . . . . . . . . . . . 13
</TABLE>
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<PAGE> 4
Contract No. NO1-CP-62601
<TABLE>
<S> <C>
PART II - CONTRACT CLAUSES . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
SECTION I - CONTRACT CLAUSES . . . . . . . . . . . . . . . . . . . . . . . . 15
ARTICLE I.1. GENERAL CLAUSES FOR A COST-REIMBURSEMENT RESEARCH AND
DEVELOPMENT CONTRACT . . . . . . . . . . . . . . . . . . . . . . . 15
ARTICLE I.2. AUTHORIZED SUBSTITUTIONS OF CLAUSES . . . . . . . . . . . 19
ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES . . . . . . . . . . . . . . . 19
ARTICLE I.4. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT . . 20
PART III . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
SECTION J - LIST OF ATTACHMENTS . . . . . . . . . . . . . . . . . . . . . . 27
Statement of Work . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Invoice/Financing Request Instructions for NIH Cost-Reimbursement
Type Contracts . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Financial Report of Individual Project/Contract, NIH 2706 . . . . . . . 27
Instructions for Completing form NIH 2706 . . . . . . . . . . . . . . . 27
Safety and Health . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Procurement of Certain Equipment . . . . . . . . . . . . . . . . . . . 27
Government-Furnished Property . . . . . . . . . . . . . . . . . . . . . 27
PART IV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
SECTION K - REPRESENTATIONS AND CERTIFICATIONS . . . . . . . . . . . . . . . 28
Representations and Certifications . . . . . . . . . . . . . . . . . . 28
Animal Welfare Assurance Number . . . . . . . . . . . . . . . . . . . . 28
Radioactive Material License . . . . . . . . . . . . . . . . . . . . . 28
</TABLE>
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Contract No. NO1-CP-62601
SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS
ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES
The purpose of this contract is to provide for the housing, feeding, and care
of patas and cynomolgus monkeys, and to provide technical assistance in the
form of carcinogen or promoter administration to animals, monitoring of
animals, administration of medication where appropriate, maintenance of records
and assistance in performing surgical and necropsy procedures.
ARTICLE B.2. ESTIMATED COST AND FIXED FEE
a. The estimated cost of this contract is $3,049,295.
b. The fixed fee for this contract is $216,855. The fixed fee shall be paid
in installments based on the percentage of completion of work, as
determined by the Contracting Officer, and subject to the withholding
provisions of the clauses ALLOWABLE COST AND PAYMENT and FIXED FEE
referenced in the General Clause Listing in Part II, ARTICLE I.1. of this
contract. Payment of fixed fee shall not be made in less than monthly
increments.
c. The Government's obligation, represented by the sum of the estimated cost
plus fixed fee, is $3,266,150.
d. Total funds currently available for payment and allotted to this contract
are $597,666, of which $557,845 represents the estimated costs, and of
which $39,821 represents the fixed fee. For further provisions on
funding, see the LIMITATION OF FUNDS Clause referenced in Part II, ARTICLE
I.2. Authorized Substitutions of Clauses.
e. It is estimated that the amount currently allotted will cover performance
of the contract through December 18, 1996.
f. The Contracting Officer may allot additional funds to the contract without
the concurrence of the Contractor.
ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS
a. Items Unallowable Unless Otherwise Provided
Notwithstanding the clauses, ALLOWABLE COST AND PAYMENT, and FIXED FEE,
incorporated in this contract, unless authorized in writing by the
Contracting Officer, the costs of the following items or activities shall
be unallowable as direct costs:
(1) Acquisition, by purchase or lease, of any interest in real property;
(2) Special rearrangement or alteration of facilities;
(3) Purchase or lease of any item of general purpose office furniture or
office equipment regardless of dollar value. (General purpose
equipment is defined as any items of personal property which are
usable for purposes other than research, such as office equipment and
furnishings, pocket calculators, etc.);
(4) Travel to attend general scientific meetings;
(5) Foreign travel;
(6) Patient care costs;
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Contract No. NO1-CP-62601
(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. Requests for computer
equipment will be screened to ensure that they meet EPA "Energy Star"
requirements;
(8) Subcontracts; and
(9) Consultants.
b. Travel Costs
(1) Domestic Travel
(a) Total expenditures for domestic travel (transportation, lodging,
subsistence, and incidental expenses) incurred in direct
performance of this contract shall not exceed $ -0- without the
prior written approval of the Contracting Officer.
ARTICLE B.4. ADVANCE UNDERSTANDINGS
Other provisions of this contract notwithstanding, approval of the following
items within the limits set forth is hereby granted without further
authorization from the Contracting Officer.
a. Overtime
Overtime (premium) pay is authorized for the purpose of caring for animals
on holidays and weekends by the animal technicians and caretakers in an
amount not to exceed $14,708 for the duration of this contract.
b. Animal Cage Rental
Animal cage rental costs are authorized in an amount not to exceed
$104,432 for the duration of this contract.
C. Animal Ownership
All animals transferred to this contract from predecessor contract
#NO1-CP-15657, including infants born to the animals in the colony, are
the property of the U.S. Government.
d. Overhead
Labor associated with animal enrichment and administrative support shall
be included in overhead, and not directly charged to this contract.
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
December 1995, attached hereto and made a part of this contract.
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Contract No. NO1-CP-62601
ARTICLE C.2. REPORTING REQUIREMENTS
a. Technical Reports
In addition to those reports required by the other terms of this contract,
the Contractor shall prepare and submit the following reports in the
manner stated below and in accordance with ARTICLE F.1. DELIVERIES of
this contract:
(1) Semi-Annual Progress Report
The initial report shall be submitted for the first full six months
of contract performance including any fractional part of the initial
month. Thereafter, the reporting period shall consist of six full
calendar months. The report shall include a summary of progress made
during the semi-annual period covered, projections for the following
period, anticipated problems, if any, and proposed corrective action.
Each report shall include a list of the monkeys currently in the
colony, including their age and the chemical treatments they have
received; a list and brief description of each experimental procedure
carried out during the period and its outcome, which shall be grouped
under protocol number and title; and any illnesses or health problems
in any of the animals. A semiannual report is not required for the
period when an annual or final report is due.
(2) Annual Progress Report
The initial report shall be submitted for the first full twelve
months of contract performance including any fractional part of the
initial month. Thereafter, the reporting period shall consist of
twelve full calendar months. This report shall include a summation
of the results of the entire contract work for the annual period
covered and shall contain the same detail as required in the
semi-annual reports. An annual report is not required for the period
when the final report is due.
(3) Final Report
This report shall include a summation of the work performed and
results obtained for the entire contract period of performance. This
report shall be in sufficient detail to describe comprehensively the
results achieved.
b. Other Reports and Deliverables
(4) Case Reports, Fixed Tissues, Biological Specimens
These deliverables will be picked up by a representative of the
Laboratory of Comparative Carcinogenesis, NCI, at intervals agreed
upon by the Project Officer and the Principal Investigator, or mailed
to collaborating third parties.
(5) Pregnancy Listings
The Contractor shall provide a monthly listing of pregnant monkeys by
number, including pregnancy stage, number of cesarians, and previous
chemical treatments.
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Contract No. NO1-CP-62601
SECTION D - PACKAGING, MARKING AND SHIPPING
ARTICLE D.1. PACKAGING
The contractor shall package all reports and deliverables in such a manner that
they are not damaged and are received by the Government in usable condition.
ARTICLE D.2. MARKING
All reports and deliverables under this contract shall be clearly marked with
the contract number. Case Reports, Fixed Tissues, and Biological Specimens
shall also be labeled to properly identify and protect the contents.
ARTICLE D.3. SHIPPING
The contractor shall ship all reports and deliverables in accordance with the
delivery schedule in Section F herein. It is anticipated that no express mail
shipments will be required under this contract.
SECTION E - INSPECTION AND ACCEPTANCE
a. The Contracting Officer or the duly authorized representative will perform
inspection and acceptance of materials and services to be provided.
b. For the purpose of this ARTICLE, the Project Officer is the authorized
representative of the Contracting Officer.
c. Inspection and acceptance will be performed at Building #538, Room 205,
Frederick Cancer Research and Development Center, National Cancer
Institute, Frederick, Maryland 21701-1013.
Acceptance may be presumed unless otherwise indicated in writing by the
Contracting Officer or the duly authorized representative within 60 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 52.246-8, INSPECTION OF RESEARCH AND
DEVELOPMENT--COST-REIMBURSEMENT (APRIL 1984).
SECTION F - DELIVERIES OR PERFORMANCE
ARTICLE F.1. DELIVERIES
Satisfactory performance of this contract shall be deemed to occur upon
delivery and acceptance by the Contracting Officer, or the duly authorized
representative, of the following items in accordance with the stated delivery
schedule:
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Contract No. NO1-CP-62601
The items specified below as described in SECTION C, ARTICLE C.2. shall be
delivered f.o.b. destination as set forth in FAR 52.247-35, F.O.B. DESTINATION,
WITHIN CONSIGNEE'S PREMISES (APRIL 84) and in accordance with and by the dates
specified below and any specifications stated in SECTION D, PACKAGING, MARKING
AND SHIPPING, of this contract:
<TABLE>
<CAPTION>
Item Description Quantity Delivery Schedule
---- ----------- -------- -----------------
<S> <C> <C> <C>
(1) Semi-Annual Reports 3 Due on or before:
July 18, 1996
July 18, 1997
July 18, 1998
July 18, 1999
July 18, 2000
(2) Annual Reports 3 January 18, 1997
January 18, 1998
January 18, 1999
January 18, 2000
(3) Final Report 3 Due on or before
expiration date
of contract
(4) Case Reports, Fixed Tissues, As specified by As specified by
and Biological Specimens Project Officer Project Officer
(5) Pregnancy Listings 2 January 30, 1996 and
the 30th of every
month thereafter.
</TABLE>
The above items shall be addressed and delivered to:
<TABLE>
<CAPTION>
Addressee Deliverable Item No. Quantity
--------- -------------------- --------
<S> <C> <C>
Project Officer (1) through (3) 2
Frederick Cancer Research and (4) As specified by
Development Center, NCI Project Officer
Building #538, Room 205 (5) 2
Frederick, MD 21701-1013
Contracting Officer (1) through (3) 1
Research Contracts Branch
National Cancer Institute
6120 Executive Boulevard, MSC 7224
Bethesda, Maryland 20892-7224
</TABLE>
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Contract No. NO1-CP-62601
ARTICLE F.2. 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 CHAPTER 1) CLAUSE: 52.242-15, STOP
WORK ORDER (AUGUST 1989) with ALTERNATE I (APRIL 1984).
SECTION G - CONTRACT ADMINISTRATION DATA
ARTICLE G.1. PROJECT OFFICER
The following Project Officers will represent the Government for the purpose of
this contract:
Dr. Lucy M. Anderson, Project Officer
Ms. Ann Butler Jones, Assistant Project Officer
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:
<TABLE>
<CAPTION>
NAME TITLE
---- -----
<S> <C>
Dr. Richard P. Bradbury Principal Investigator
Dr. Stephanie Krasnow Veterinarian
Dr. Tom Moskal Veterinarian
Steven Harbaugh Lead Animal Technician
Jeffrey Harbaugh Animal Technician
</TABLE>
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Contract No. NO1-CP-62601
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
Division of Financial Management
Chief, Contract Accounting Branch, DEFS
Building 31, Room B1B05A
31 CENTER DR MSC 2050
BETHESDA MD 20892-2050
(2) Three copies to the following approving officer:
Contracting Officer
Research Contracts Branch
National Cancer Institute, NIH
Executive Plaza South, 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 Branch,
DEFS, (301) 496-6452.
b. The Contractor shall include the following certification on every invoice
for reimbursable costs incurred with Fiscal Year funds subject to the
salary rate limitation provisions as specified in ARTICLE H.4. of this
contract. For billing purposes, certified invoices are required for the
billing period during which the applicable Fiscal Year funds were
initially charged through the final billing period utilizing the
applicable Fiscal Year funds:
"I hereby certify that the salaries charged in this invoice are in
compliance with P.L. [cite the applicable Public Law Number for the
applicable Fiscal Year as stated in ARTICLE H.4.] and ARTICLE H.4. of
the above referenced contract."
ARTICLE G.4. CONTRACT FINANCIAL REPORT
a. Financial reports on the attached Form NIH 2706, Financial Report of
Individual Project/Contract, shall be submitted by the Contractor in
accordance with the Instructions for Completing Form NIH 2706, which
accompany the form, in an original and two copies, not later than the 30th
working day after the close of the reporting period. The line entries for
subdivisions of work and elements of cost (expenditure categories) which
shall be reported within the total contract are listed in paragraph e.,
below. Subsequent changes and/or additions in the line entries shall be
made in writing.
b. 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.
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Contract No. NO1-CP-62601
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:
<TABLE>
<CAPTION>
Expenditure Category
A Hours
-------------------- -----
<S> <C>
(1) Direct Labor
(a) Principal Investigator
(b) Veterinarians
(c) Animal Technicians/Caretakers
(2) Fringe Benefits
(3) Overhead
(4) Materials/Supplies
(5) Overtime
(6) Animal Cage Rental
(7) Equipment Maintenance
(8) General & Administrative
(9) Fixed Fee
(10) Total Cost Plus Fixed Fee
</TABLE>
ARTICLE G.5. INDIRECT COST RATES
In accordance with Federal Acquisition Regulation (FAR) (48 CFR Chapter 1)
Clause 52.216-7 (d)(2), Allowable Cost and Payment incorporated by reference in
this contract in Part II, Section I, the cognizant Contracting Officer
responsible for negotiating provisional and/or final indirect cost rates is
identified as follows:
Chief, Financial Advisory Services Branch
Division of Contracts and Grants
National Institutes of Health
6100 EXECUTIVE BLVD ROOM 6B05/MSC 7540
BETHESDA MD 20892-7540
These rates are hereby incorporated without further action of the Contracting
Officer.
ARTICLE G.6. GOVERNMENT PROPERTY
a. In addition to the requirements of the clause, GOVERNMENT PROPERTY,
incorporated in Section I of this contract, the Contractor shall comply
with the provisions of DHHS Publication, Contractor's Guide for Control of
Government Property, (1990), which is incorporated into this contract by
reference. Among other issues, this publication provides a summary of the
Contractor's responsibilities regarding purchasing authorizations and
inventory and reporting requirements under the contract. A copy of this
publication is available upon request to the Contract Property
Administrator.
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Contract No. NO1-CP-62601
This contract's Contract Property Administrator is:
David A. Hubbard, II
Contracts Property Administrator
Research Contracts Property Administration, NIH
13 SOUTH DR MSC 5748
BETHESDA MD 20892-5748
(301) 496-6467
b. Property Acquired Under Predecessor Contract - Schedule II-A
Pursuant to the clause, GOVERNMENT PROPERTY, incorporated in this
contract, the Contractor is hereby authorized to retain custody of all
Government Property acquired or furnished under predecessor Contract No.
NO1-CP-15657 for use in direct performance of this contract.
Accountability for the items is hereby authorized to be transferred to
this contract from the predecessor contract. Upon completion of each
contract, the Contractor agrees to furnish to the Contracting Officer,
without delay, the inventory schedule covering all Government Property
furnished or acquired for use in the performance of the predecessor
contract as provided by the clause, GOVERNMENT PROPERTY, of that contract
and the instructions contained in DHHS Publication entitled, Contractor's
Guide for Control of Government Property, (1990).
ARTICLE G.7. GOVERNMENT SUPPLY SOURCES
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 CHAPTER 1) CLAUSE: 52.251-01,
GOVERNMENT SUPPLY SOURCES
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 totalling approximately 7 billion
dollars annually. PHS has established effective, time tested and well
recognized procedures for stimulating and supporting this independent research
by selecting from multitudes of applications those research projects most
worthy of support within the constraints of its appropriations. The
reimbursement through the indirect cost mechanism of independent research and
development costs not incidental to product improvement would circumvent this
competitive process.
To ensure that all research and development projects receive similar and equal
consideration, all organizations may compete for direct funding of independent
research and development projects they consider worthy of support by submitting
those projects to the appropriate Public Health Service grant office for
review. Since these projects may be submitted for direct funding, the
Contractor agrees that no costs for any independent research and development
project, including all applicable indirect costs, will be claimed under this
contract.
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Contract No. NO1-CP-62601
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. ANIMAL WELFARE ASSURANCE
The Contractor shall perform all animal-related work under this contract in
accordance with Animal Assurance #A-3086-01. The Contractor shall maintain
such assurance for the duration of this contract, and any subcontractors
performing work under this contract involving the use of animals shall also
obtain and maintain an approved Animal Welfare Assurance.
ARTICLE H.4. SALARY RATE LIMITATION LEGISLATION PROVISIONS
a. Pursuant to Public Law(s) cited in paragraph b., below, no NIH Fiscal Year
funds may be used to pay the direct salary of an individual through this
contract at a rate in excess of applicable amount shown for the fiscal
year covered. Direct salary is exclusive of overhead, fringe benefits and
general and administrative expenses. The per year salary rate limit also
applies to individuals proposed under subcontracts. If this is a
multi-year contract, it may be subject to unilateral modifications by the
Government if an individual's salary rate exceeds any salary rate ceiling
established in future DHHS appropriation acts.
<TABLE>
<CAPTION>
Dollar Amount of
b. Public Law No. Fiscal Year Period Salary Limitation
-------------- ----------- ------ -----------------
<S> <C> <C> <C>
</TABLE>
INFORMATION ON THE FISCAL YEAR 1996 SALARY LIMITATION WILL BE
INCORPORATED INTO THIS CONTRACT UPON PASSAGE BY CONGRESS.
ARTICLE H.5. 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 Number [insert number]."
13
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CONTRACT NO. NO1-CP-62601
PART II - CONTRACT CLAUSES
14
<PAGE> 16
Contract No. NO1-CP-62601
PART II
SECTION I - CONTRACT CLAUSES
ARTICLE I.1. GENERAL CLAUSES FOR A COST-REIMBURSEMENT RESEARCH AND DEVELOPMENT
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:
<TABLE>
<CAPTION>
FAR
CLAUSE NO. TITLE AND DATE
--------- --------------
<S> <C>
52.202-1 Definitions (OCTOBER 1995)
52.203-3 Gratuities (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) (OCTOBER 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 1990)
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)
(MAY 1995)
52.209-6 Protecting the Government's Interests when Subcontracting with
Contractors Debarred, Suspended, or Proposed for Debarment
(AUGUST 1995)
52.215-2 Audit and Records - Negotiation (Over $100,000) (OCTOBER 1995)
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 (SEPTEMBER 1989)
52.215-33 Order of Precedence (JANUARY 1986)
52.215-39 Reversion or Adjustment of Plans for Post-Retirement Benefits
other than Pensions (PRB) (FEBRUARY 1995)
</TABLE>
15 10/95
<PAGE> 17
Contract No. NO1-CP-62601
<TABLE>
<S> <C>
52.215-40 Notification of Ownership Changes (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 (JULY 1991)
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) (OCTOBER 1995)
52.219-16 Liquidated Damages - Subcontracting Plan (Over $500,000) (OCTOBER
1995)
52.220-1 Preference for Labor Surplus Area Concerns (Over $100,000) (APRIL
1984)
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 (APRIL 1984)
52.222-26 Equal Opportunity (APRIL 1984)
52.222-28 Equal Opportunity Preaward Clearance of Subcontracts (Over
$1,000,000) (APRIL 1984)
52.222-35 Affirmative Action for 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 1995)
52.225-3 Buy American Act--Supplies (JANUARY 1994)
52.225-11 Restrictions on Certain Foreign Purchases (MAY 1992)
52.227-1 Authorization and Consent (Over $50,000) (JULY 1995)--Alternate I
(APRIL 1984)
52.227-2 Notice and Assistance Regarding Patent and Copyright Infringement
(Over $100,000) (APRIL 1984)
52.227-11 Patent Rights - Retention by the Contractor (Short Form) (JUNE
1989) NOTE: In accordance with FAR 27.303(a)(2), paragraph (f) is
modified to include the requirements in FAR 27.303(a)(2) (i)
through (iv). The frequency of reporting in (i) is annual.
</TABLE>
16 10/95
<PAGE> 18
Contract No. NO1-CP-62601
<TABLE>
<S> <C>
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) (JANUARY 1991)
52.232-20 Limitation of Cost (APRIL 1984)
52.232-23 Assignment of Claims (JANUARY 1986)
52.232-25 Prompt Payment (MARCH 1994)
52.232-28 Electronic Funds Transfer Payment Methods (APRIL 1989)
52.233-1 Disputes (OCTOBER 1995)
52.233-3 Protest After Award (OCTOBER 1995) With Alternate I (JUNE 1985)
52.242-1 Notice of Intent to Disallow Costs (APRIL 1984)
52.242-3 Penalties for Unallowable Costs (Over $500,000) (OCTOBER 1995)
52.242-4 Certification of Indirect Costs (OCTOBER 1995)
52.242-13 Bankruptcy (Over $100,000) (JULY 1995)
52.243-2 Changes - Cost Reimbursement (AUGUST 1987) Alternate V (APRIL
1984)
52.244-2 Subcontracts (Cost-Reimbursement and Letter Contracts) (FEBRUARY
1995) *If written consent to subcontract is required, the
identified subcontracts are listed in ARTICLE B, Advance
Understandings.
52.244-5 Competition in Subcontracting (Over $100,000) (APRIL 1984)
52.245-5 Government Property (Cost-Reimbursement, Time and Material, or
Labor-Hour Contract) (JANUARY 1986)
52.246-23 Limitation of Liability (Over $100,00) (APRIL 1984)
52.249-6 Termination (Cost-Reimbursement) (MAY 1986)
52.249-14 Excusable Delays (APRIL 1984)
52.253-1 Computer Generated Forms (JANUARY 1991)
</TABLE>
b. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48
CFR CHAPTER 3) CLAUSES:
<TABLE>
<CAPTION>
HHSAR
CLAUSE NO. TITLE AND DATE
---------- --------------
<S> <C>
352.202-1 Definitions (APRIL 1984) Alternate I (APRIL 1984)
352.228-7 Insurance - Liability to Third Persons (DECEMBER 1991)
</TABLE>
17 10/95
<PAGE> 19
Contract No. NO1-CP-62601
<TABLE>
<S> <C>
352.232-9 Withholding of Contract Payments (APRIL 1984)
352.233-70 Litigation and Claims (APRIL 1984)
352.242-71 Final Decisions on Audit Findings (APRIL 1984)
352.270-5 Key Personnel (APRIL 1984)
352.270-6 Publication and Publicity (JULY 1991)
352.270-7 Paperwork Reduction Act (APRIL 1984)
</TABLE>
[End of GENERAL CLAUSES FOR A COST-REIMBURSEMENT RESEARCH AND DEVELOPMENT
CONTRACT]
18 10/95
<PAGE> 20
Contract No. NO1-CP-62601
ARTICLE I.2. AUTHORIZED SUBSTITUTIONS OF CLAUSES
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.
FAR Clause 52.232-20, LIMITATION OF COST, is deleted in its entirety and FAR
Clause 52.232-22, LIMITATION OF FUNDS (APRIL 1984) is substituted therefor.
ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES
This contract incorporates the following clauses by reference, with the same
force and effect, as if they were given in full text. Upon request, the
contracting officer will make their full text available.
a. FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES
FAR 52.215-31, Waiver of Facilities Capital Cost of Money (SEPTEMBER
1987).
FAR 52.223-7, Notice of Radioactive Materials (NOVEMBER 1991).
"(a) The Contractor shall notify the Contracting Officer or designee,
in writing, 10 days prior to the delivery of, or prior to
completion of any servicing required..."
FAR 52.225-19, European Community Sanction for Services (MAY 1995)
Alternate I (JUNE 1987), FAR 52.227-14, Rights in Data--General (JUNE
1987). FAR 52.227-14, Rights in Data - General (JUNE 1987), Alternate IV
(JUNE 1987)
FAR 52.244-5, Competition in Subcontracting (APRIL 1984)
b. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION/PUBLIC
HEALTH SERVICE ACQUISITION REGULATION (HHSAR)/(PHSAR) (48 CHAPTER 3)
CLAUSES:
PHS 352.223-70, Safety and Health (APRIL 1984)
PHS 352.280-2b, Care of Live Vertebrate Animals (OCTOBER 1986).
C. NATIONAL INSTITUTES OF HEALTH (NIH) RESEARCH CONTRACTING (RC) CLAUSES:
The following clauses are attached and made a part of this contract:
NIH (RC)-7, Procurement of Certain Equipment (APRIL 1984) (OMB Bulletin
81-16)
19
<PAGE> 21
Contract No. NO1-CP-62601
ARTICLE I.4. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT
a. FAR Clause 52.202-1 DEFINITIONS (OCTOBER 1995)
"....
(b) COMMERCIAL COMPONENT means any component that is a commercial item.
(c) COMMERCIAL ITEM means-
(1) Any item, other than real property, that is of a type customarily
used for nongovernmental purposes and that-
(i) Has been sold, leased, or licensed to the general public; or
(ii) Has been offered for sale, lease, or license to the general
public;
(2) Any item that evolved from an item described in paragraph (c)(1)
of this clause through advances in technology or performance and
that is not yet available in the commercial marketplace, but
will be available in the commercial marketplace in time to
satisfy the delivery requirements under a Government
solicitation;
(3) Any item that would satisfy a criterion expressed in paragraphs
(c)(1) or (c)(2) of this clause, but for-
(i) Modifications of a type customarily available in the
commercial marketplace; or
(ii) Minor modifications of a type not customarily available in
the commercial marketplace made to meet Federal Government
requirements. "Minor" modifications means modifications
that do not significantly alter the nongovernmental
function or essential physical characteristics of an item
or component, or change the purpose of a process. Factors
to be considered in determining whether a modification is
minor include the value and size of the modification and
the comparative value and size of the final product.
Dollar values and percentages may be used as guideposts,
but are not conclusive evidence that a modification is
minor;
(4) Any combination of items meeting the requirements of paragraphs
(c)(1), (2), (3), or (5) of this clause that are of a type
customarily combined and sold in combination to the general
public;
(5) Installation services, maintenance services, repair services,
training services, and other services if such services are
procured for support of an item referred to in paragraphs (c)(1),
(2), (3), or (4) of this clause, and if the source of such
services-
(i) Offers such services to the general public and the Federal
Government contemporaneously and under similar terms and
conditions; and
(ii) Offers to use the same work force for providing the Federal
Government with such services as the source uses for
providing such services to the general public;
(6) Services of a type offered and sold competitively in substantial
quantities in the commercial marketplace based on established
catalog or market prices for specific tasks performed under
standard commercial terms and conditions. This does not include
services that are sold based on hourly rates without an
established catalog or market price for a specific service
performed;
(7) Any item, combination of items, or service referred to in
subparagraphs (c)(1) through (c)(6), notwithstanding the fact
that the item, combination of items, or service is transferred
between or among separate divisions, subsidiaries, or
affiliates of a Contractor; or
20
<PAGE> 22
Contract No. NO1-CP-62601
(8) A nondevelopmental item, if the procuring agency determines the
item was developed exclusively at private expense and sold in
substantial quantities, on a competitive basis, to multiple
State and local Governments.
(d) COMPONENT means any item supplied to the Federal Government as part
of an end item or of another component.
(e) NONDEVELOPMENTAL ITEM means-
(1) Any previously developed item of supply used exclusively for
governmental [*48251] purposes by a Federal agency, a State or
local government, or a foreign government with which the United
States has a mutual defense cooperation agreement;
(2) Any item described in paragraph (e)(1) of this definition that
requires only minor modification or modifications of a type
customarily available in the commercial marketplace in order to
meet the requirements of the procuring department or agency; or
(3) Any item of supply being produced that does not meet the
requirements of paragraph (e)(1) or (e)(2) solely because the
item is not yet in use...."
b. 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 3.104-4 are hereby
incorporated in this clause.
(b) The Contractor agrees that it will execute the certification set
forth in paragraph (c) of this clause when requested by the
Contracting Officer in connection with the execution of any
modification of this contract.
(c) CERTIFICATION. As required in paragraph (b) of this clause, the
officer or employee responsible for the modification proposal shall
execute the following certification. The certification in paragraph
(c)(2) of this clause is not required for a modification which
procures commercial items.
CERTIFICATE OF PROCUREMENT INTEGRITY--MODIFICATION (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 MODIFICATION
NUMBER].
(2) As required by subsection 27(e)(1)(B) of the Act, I further
certify that to the best of my knowledge and belief, each
officer, employee, agent, representative, and consultant of
____________________ [NAME OF OFFEROR] who has participated
personally and substantially in the preparation or submission
of this proposal has certified that he or she is familiar with,
and will comply with, the requirements of subsection 27(a) of
the Act, as implemented in the FAR, and will report immediately
to me any information concerning a violation or possible
violation of subsections 27(a), (b), (d), or (f) of the Act, as
implemented in the FAR, pertaining to this procurement.
21
<PAGE> 23
Contract No. NO1-CP-62601
(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.
THIS CERTIFICATION CONCERNS A MATTER WITHIN THE JURISDICTION OF
AN AGENCY OF THE UNITED STATES AND THE MAKING OF A FALSE,
FICTITIOUS, OR FRAUDULENT CERTIFICATION MAY RENDER THE MAKER
SUBJECT TO PROSECUTION UNDER TITLE 18, UNITED STATES CODE,
SECTION 1001.
[End of certification]
(d) In making the certification in paragraph (2) of the certificate, the
officer or employee of the competing Contractor responsible for the
offer or bid, may rely upon a one-time certification from each
individual required to submit a certification to the competing
Contractor, supplemented by periodic training. These certifications
shall be obtained at the earliest possible date after an individual
required to certify begins employment or association with the
Contractor. If a contractor decides to rely on a certification
executed prior to the suspension of section 27 (i.e., prior to
December 1, 1989), the Contractor shall ensure that an individual who
has so certified is notified that section 27 has been reinstated.
These certifications shall be maintained by the Contractor for a
period of 6 years from the date a certifying employee's employment
with the company ends or, for an 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]
C. FAR Clause 52.204-4 PRINTING/COPYING DOUBLE-SIDED ON RECYCLED PAPER (MAY
1995)
(a) In accordance with Executive Order 12873, dated October 20, 1993, the
Offeror/Contractor is encouraged to submit paper documents, such as
offers, letters, or reports, that are printed/copied double-sided on
recycled paper that has at least 20% postconsumer material.
(b) The 20% standard applies to high-speed copier paper, offset paper,
forms bond, computer printout paper, and carbonless paper. A higher
standard of 50% recovered material, with 20% postconsumer material,
applies to other uncoated printing and writing papers such as writing
and office paper, book paper, cotton fiber paper, and cover stock.
An alternative standard for either of the standards specified in this
clause is 50% recovered material content of certain industrial
by-products.
22
<PAGE> 24
Contract No. NO1-CP-62601
d. FAR Clause 52.215-42 REQUIREMENTS FOR COST OR PRICING DATA OR INFORMATION
OTHER THAN COST OR PRICING DATA--MODIFICATIONS
(OCTOBER 1995)
(a) EXCEPTIONS FROM COST OR PRICING DATA.
(1) In lieu of submitting cost or pricing data for modifications
under this contract, for price adjustments expected to exceed
the threshold set forth at FAR 15.804-2(a)(1) on the date of the
agreement on price or the date of the award, whichever is later,
the Contractor may submit a written request for exception by
submitting the information described in the following
subparagraphs. The Contracting Officer may require additional
supporting information, but only to the extent necessary to
determine whether an exception should be granted, and whether
the price is fair and reasonable-
(i) Information relative to an exception granted for prior or
repetitive acquisitions.
(ii) Catalog price information as follows:
(A) Attach a copy of or identify the catalog and its date, or
the appropriate pages for the offered items, or a statement
that the catalog is on file in the buying office to which
this proposal is being made.
(B) Provide a copy or describe current discount policies and
price lists (published or unpublished), e.g., wholesale,
original equipment manufacturer, and reseller.
(C) Additionally, for each catalog item that exceeds _________*
(extended value not unit price), provide evidence of
substantial sales to the general public. This may include
sales order, contract, shipment, invoice, actual recorded
sales or other records that are verifiable. In addition,
if the basis of the price proposal is sales of essentially
the same commercial item by affiliates, other manufacturers
or vendors, those sales may be included. The offeror shall
explain the basis of each offered price and its
relationship to the established catalog price. When
substantial general public sales have also been made at
prices other than catalog or price list prices, the offeror
shall indicate how the proposed price relates to the price
of such recent sales in quantities similar to the proposed
quantities.
* Insert dollar amount for sampling (see 15.804-1(c)(1)).
(iii) Market price information. Include the source and date or
period of the market quotation or other basis for market
price, the base amount, and applicable discounts. The nature
of the market should be described. The supply or service
being purchased should be the same as or similar to the market
price supply or service. Data supporting substantial sales to
the general public is also required.
(iv) Identification of the law or regulation establishing the price
offered. If the price is controlled under law by periodic
rulings, reviews, or similar actions of a governmental body,
attach a copy of the controlling document, unless it was
previously submitted to the contracting office.
(v) Information on modifications of contracts or subcontracts for
commercial items.
(A) If (1) The original contract or subcontract was granted an
exception from cost or pricing data requirements because
the price agreed upon was based on adequate price
competition, catalog or market prices of commercial items,
or prices set by law or regulation; and (2) the
modification (to the contract or subcontract) is not
exempted based on one of these exceptions, then the
Contractor may provide information to establish that the
modification would not change the contract or subcontract
from a contract or subcontract for the acquisition of a
commercial item to a contract or subcontract for the
acquisition of an item other than a commercial item.
23
<PAGE> 25
Contract No. NO1-CP-62601
(B) For a commercial item exception, the Contractor may provide
information on prices at which the same item or similar
items have been sold in the commercial market.
(2) The Contractor grants the Contracting Officer or an authorized
representative the right to examine, at any time before award,
books, records, documents, or other directly pertinent records
to verify any request for an exception under this clause, and
the reasonableness of price. Access does not extend to cost or
profit information or other data relevant solely to the
Contractor's determination of the prices to be offered in the
catalog or marketplace.
(3) By submitting information to qualify for an exception, an
offeror is not representing that this is the only exception
that may apply.
(b) REQUIREMENTS FOR COST OR PRICING DATA. If the Contractor is not
granted an exception from the requirement to submit cost or pricing
data, the following applies:
(1) The Contractor shall submit cost or pricing data on Standard Form
(SF) 1411, Contract Pricing Proposal Cover Sheet (Cost or
Pricing Data Required), with supporting attachments prepared in
accordance with Table 15-2 of FAR 15.804-6(b)(2).
(2) As soon as practicable after agreement on price, but before award
(except for unpriced actions), the Contractor shall submit a
Certificate of Current Cost or Pricing Data, as prescribed by FAR
15.804-4.
(End of clause.)
e. FAR Clause 52.242-3 PENALTIES FOR UNALLOWABLE COSTS (OCTOBER 1995)
(a) Definition. Proposal, as used in this clause, means either-
(1) A final indirect cost rate proposal submitted by the Contractor
after the expiration of its fiscal year which-
(i) Relates to any payment made on the basis of billing rates;
or
(ii) Will be used in negotiating the final contract price; or
(2) The final statement of costs incurred and estimated to be
incurred under the Incentive Price Revision clause (if
applicable), which is used to establish the final contract
price.
(b) Contractors which include unallowable indirect costs in a proposal
may be subject to penalties. The penalties are prescribed in 10
U.S.C. 2324 or 41 U.S.C. 256, as applicable, which is implemented in
Section 42.709 of the Federal Acquisition Regulation (FAR).
(c) The Contractor shall not include in any proposal any cost which is
unallowable, as defined in Part 31 of the FAR, or an executive agency
supplement to Part 31 of the FAR.
(d) If the Contracting Officer determines that a cost submitted by the
Contractor in its proposal is expressly unallowable under a cost
principle in the FAR, or an executive agency supplement to the FAR,
that defines the allowability of specific selected costs, the
Contractor shall be assessed a penalty equal to-
(1) The amount of the disallowed cost allocated to this contract;
plus
24
<PAGE> 26
Contract No. NO1-CP-62601
(2) Simple interest, to be computed-
(i) On the amount the Contractor was paid (whether as a
progress or billing payment) in excess of the amount to
which the Contractor was entitled; and
(ii) Using the applicable rate effective for each six-month
interval prescribed by the Secretary of the Treasury
pursuant to Pub. L. 92-41 (85 Stat. 97).
(e) If the Contracting Officer determines that a cost submitted by the
Contractor in its proposal includes a cost previously determined to
be unallowable for that Contractor, then the Contractor will be
assessed a penalty in an amount equal to two times the amount of the
disallowed cost allocated to this contract.
(f) Determinations under paragraphs (d) and (e) of this clause are final
decisions within the meaning of the Contract Disputes Act of 1978 (41
U.S.C. 601, et seq.).
(g) Pursuant to the criteria in FAR 42.709-5, the Contracting Officer may
waive the penalties in paragraph (d) or (e) of this clause.
(h) Payment by the Contractor of any penalty assessed under this clause
does not constitute repayment to the Government of any unallowable
cost which has been paid by the Government to the Contractor.
f. FAR Clause 52.242-4 CERTIFICATION OF INDIRECT COSTS (OCTOBER 1995)
(a) The Contractor shall-
(1) Certify any proposal to establish or modify billing rates or to
establish final indirect cost rates;
(2) Use the format in paragraph (c) of this clause to certify; and
(3) Have the certificate signed by an individual of the Contractor's
organization at a level no lower than a vice president or chief
financial officer of the business segment of the Contractor that
submits the proposal.
(b) Failure by the Contractor to submit a signed certificate, as
described in this clause, shall result in payment of indirect costs
at rates unilaterally established by the Government.
(c) The certificate of indirect costs shall read as follows:
CERTIFICATE OF INDIRECT COSTS
This is to Certify that to the best of my knowledge and belief:
1. I have reviewed this indirect cost proposal;
2. All costs included in this proposal (identify proposal and date)
to establish billing or final indirect costs rates for (identify
period covered by rate) are allowable in accordance with the
requirements of contracts to which they apply and with the cost
principles of the Federal Acquisition Regulation (FAR) and its
supplements applicable to those contracts;
3. This proposal does not include any costs which are unallowable
under applicable cost principles of the FAR or its supplements,
including, but not limited to: advertising and public relations
costs, contributions and donations, entertainment costs, fines
and penalties, lobbying costs, defense of fraud proceedings, and
goodwill; and
25
<PAGE> 27
Contract No. NO1-CP-62601
4. All costs included in this proposal are properly allocable to
Government contracts on the basis of a beneficial or causal
relationship between the expenses incurred and the contracts to
which they are allocated in accordance with applicable
acquisition regulations.
I declare under penalty of perjury that the foregoing is true and
correct.
Firm:
----------------------------------------------------------------
Signature:
------------------------------------------------------------
Name of Certifying Official:
------------------------------------------
Title:
----------------------------------------------------------------
Date of Execution:
----------------------------------------------------
g. FAR Clause 52.244-6 SUBCONTRACTS FOR COMMERCIAL ITEMS AND COMMERCIAL
COMPONENTS (OCTOBER 1995)
(a) DEFINITION.
COMMERCIAL ITEM, as used in this clause, has the meaning contained in
the clause at 52.202-1, Definitions.
SUBCONTRACT, as used in this clause, includes a transfer of
commercial items between divisions, subsidiaries, or affiliates of
the Contractor or subcontractor at any tier.
(b) To the maximum extent practicable, the Contractor shall incorporate,
and require its subcontractors at all tiers to incorporate,
commercial items or nondevelopmental items as components of items to
be supplied under this contract.
(c) Notwithstanding any other clause of this contract, the Contractor is
not required to include any FAR provision or clause, other than those
listed below to the extent they are applicable and as may be
required to establish the reasonableness of prices under Part 15, in
a subcontract at any tier for commercial items or commercial
components:
(1) 52.222-26, Equal Opportunity (E.O. 11246);
(2) 52.222-35, Affirmative Action for Special Disabled and Vietnam
Era Veterans (38 U.S.C. 4212(a));
(3) 52.222-36, Affirmative Action for Handicapped Workers (29 U.S.C.
793); and
(4) 52.247-64, Preference for Privately Owned U.S.-Flagged
Commercial Vessels (46 U.S.C. 1241) (flow down not required for
subcontracts awarded beginning May 1, 1996).
(d) The Contractor shall include the terms of this clause, including this
paragraph (d), in subcontracts awarded under this contract.
(End of clause)
26
<PAGE> 28
Contract No. NO1-CP-62601
PART III
SECTION J - LIST OF ATTACHMENTS
The following documents are attached and incorporated in this contract:
1. Statement of Work, December 1995, 4 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. Safety and Health, PHSAR Clause 352.223-70,(4/84), 2 pages.
6. Procurement of Certain Equipment, NIH(RC)-7, 4/l/84, 1 page.
7. Government-Furnished Property, Schedule II-A, December 1995, 5 pages.
27
<PAGE> 29
Contract No. NO1-CP-62601
PART IV
SECTION K - REPRESENTATIONS AND CERTIFICATIONS
The following documents are incorporated by reference in this contract:
1 . Representations and Certifications, dated December 6, 1995.
2. Animal Welfare Assurance Number A-3086-01.
3. Radioactive Material License, #MD-31-113-01.
END of the SCHEDULE
(CONTRACT)
28
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<PERIOD-START> JUN-01-1995
<PERIOD-END> NOV-30-1995
<CASH> 57,098
<SECURITIES> 0
<RECEIVABLES> 1,850,131
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<CURRENT-ASSETS> 2,116,778
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