U.S. SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-QSB
(MARK ONE)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE
[X] SECURITIES EXCHANGE ACT OF 1934
for the quarterly period ended November 30, 1997
-----------------
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
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(Exact name of small business issuer as specified in its charter)
State of Delaware 13-3078199
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(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification No.)
9600 Medical Center Drive, Rockville, Maryland 20850
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(Address of principal executive office) (Zip Code)
Issuer's telephone number, including area code (301) 251-2801
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; 1,600,408
shares outstanding as of January 8, 1998.
Convertible Preferred Stock, $1.00 par value per share; authorized 500,000
shares; no shares outstanding as of January 8, 1998.
Transitional Small Business Disclosure Format (Check one): Yes No X
--- ---
<PAGE>
DIAGNON CORPORATION
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INDEX
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Part I. Financial Information Page
- ------------------------------ ----
Item 1. Financial Statements.
Consolidated Balance Sheets, May 31, 1997 and
November 30, 1997 (Unaudited) . . . . . . . . . . . . . . 2
Unaudited Statements of Consolidated Operations for
the Three Months Ended November 30, 1997 and
November 30, 1996 . . . . . . . . . . . . . . . . . . . . 3
Unaudited Statements of Consolidated Operations for
the Six Months Ended November 30, 1997 and
November 30, 1996 . . . . . . . . . . . . . . . . . . . . 4
Unaudited Statements of Consolidated Cash Flows
for the Six Months Ended November 30, 1997 and
November 30, 1996 . . . . . . . . . . . . . . . . . . . . 5
Notes to Financial Statements . . . . . . . . . . . . . . . . . . 6
Item 2. Management's Discussion and Analysis . . . . . . . . . . 6
Part II. Other Information
- ---------------------------
Item 1. Legal Proceedings . . . . . . . . . . . . . . . . . . . . 9
Item 4. Submission of Matters to a Vote of
Security Holders . . . . . . . . . . . . . . . . . 10
Item 6. Exhibits . . . . . . . . . . . . . . . . . . . . . . . . 11
<PAGE>
DIAGNON CORPORATION AND SUBSIDIARIES
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CONSOLIDATED BALANCE SHEETS, MAY 31, 1997 AND NOVEMBER 30, 1997 (UNAUDITED)
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<TABLE>
<CAPTION>
ASSETS NOVEMBER 30, MAY 31,
- ------ 1997 1997
------------- --------------
<S> <C>
CURRENT ASSETS:
Cash and cash equivalents $ 64,168 $ 62,638
Accounts receivable:
Trade 875,942 1,245,292
Unbilled 585,225 598,922
Other 23,062 49,999
Prepaid expenses 102,102 76,444
Inventories 56,388 44,961
Deferred income taxes - current 50,000 50,000
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Total current assets 1,756,887 2,128,256
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LOANS TO OFFICERS 90,000 90,000
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FIXED ASSETS:
Leasehold improvements 713,560 670,899
Furniture, fixtures and equipment 3,188,563 2,985,508
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Total 3,902,123 3,656,407
Less accumulated depreciation
and amortization 2,325,332 2,182,091
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Fixed assets, net 1,576,791 1,474,316
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DEFERRED INCOME TAXES - NONCURRENT 837,800 797,400
OTHER NONCURRENT ASSETS 150,549 204,549
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TOTAL $ 4,412,027 $ 4,694,521
============= ==============
LIABILITIES
- -----------
CURRENT LIABILITIES:
Borrowings under line of credit $ 328,744 $ 536,120
Current maturities of long-term debt 135,971 124,153
Accounts payable 192,173 250,767
Accrued compensation and related costs 268,966 292,956
Accrued income taxes 6,643 5,543
Other accrued liabilities 40,181 12,641
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Total current liabilities 972,678 1,222,180
LONG-TERM DEBT 201,746 164,192
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Total liabilities 1,174,424 1,386,372
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STOCKHOLDERS' EQUITY
- --------------------
Convertible preferred stock - par value of $1.00 per share: November 30, 1997,
500,000 shares, May 31, 1997, 325,000 shares authorized; no shares issued and
outstanding
Common stock - par value of $.01 per share; 25,000,000 shares authorized;
1,600,408 shares issued; November 30, 1997, 899,505 shares, May 31, 1997,
899,707 shares outstanding 16,004 96,024
Additional paid-in capital 7,475,035 7,395,015
Accumulated deficit (3,625,568) (3,555,533)
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Total 3,865,471 3,935,506
Less - treasury stock November 30, 1997, 700,903
shares, May 31, 1997, 700,701 shares, at cost (627,868) (627,357)
------------- --------------
Total stockholders' equity 3,237,603 3,308,149
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TOTAL $ 4,412,027 $ 4,694,521
============= ==============
</TABLE>
See notes to financial statements.
2
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DIAGNON CORPORATION AND SUBSIDIARIES
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UNAUDITED STATEMENTS OF CONSOLIDATED OPERATIONS FOR THE
- -------------------------------------------------------
THREE MONTHS ENDED NOVEMBER 30, 1997 AND NOVEMBER 30, 1996
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<TABLE>
<CAPTION>
NOVEMBER 30, NOVEMBER 30,
1997 1996
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<S> <C>
REVENUES AND SALES:
Contract revenues $ 2,308,620 $ 2,231,224
Product sales 5,580 2,778
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Total Revenues and Sales 2,314,200 2,234,002
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OPERATING EXPENSES:
Contract 1,809,642 1,640,955
Cost of goods sold 7,944 1,736
Research and development 91,305 87,818
General and administrative 496,574 446,699
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Total 2,405,465 2,177,208
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OPERATING (LOSS)/INCOME (91,265) 56,794
INTEREST INCOME 1,231 1,791
INTEREST EXPENSE (12,537) (11,054)
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(LOSS)/INCOME BEFORE INCOME TAX (102,571) 47,531
(CREDIT) PROVISION FOR INCOME TAX (31,550) 19,300
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NET (LOSS)/INCOME $ (71,021) $ 28,231
============ ============
(LOSS)/INCOME PER SHARE $ (0.08) $ 0.03
============ ============
WEIGHTED AVERAGE NUMBER OF
SHARES OUTSTANDING 899,620 899,707
============ ============
</TABLE>
See notes to financial statements.
3
<PAGE>
DIAGNON CORPORATION AND SUBSIDIARIES
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UNAUDITED STATEMENTS OF CONSOLIDATED OPERATIONS FOR THE
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SIX MONTHS ENDED NOVEMBER 30, 1997 AND NOVEMBER 30, 1996
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<TABLE>
<CAPTION>
NOVEMBER 30, NOVEMBER 30,
1997 1996
------------ ------------
<S> <C>
REVENUES AND SALES:
Contract revenues $ 4,644,761 $ 4,520,531
Product sales 6,653 3,858
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Total Revenues and Sales 4,651,414 4,524,389
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OPERATING EXPENSES:
Contract 3,573,940 3,368,516
Cost of goods sold 24,422 2,356
Research and development 209,156 169,552
General and administrative 922,742 887,262
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Total 4,730,260 4,427,686
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OPERATING (LOSS)/INCOME (78,846) 96,703
INTEREST INCOME 2,569 3,592
INTEREST EXPENSE (24,658) (22,869)
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(LOSS)/INCOME BEFORE INCOME TAX (100,935) 77,426
(CREDIT) PROVISION FOR INCOME TAX (30,900) 31,300
------------ ------------
NET (LOSS)/INCOME $ (70,035) $ 46,126
============ ============
(LOSS)/INCOME PER SHARE $ (0.08) $ 0.05
============ ============
WEIGHTED AVERAGE NUMBER OF
SHARES OUTSTANDING 899,663 899,707
============ ============
</TABLE>
See notes to financial statements.
4
<PAGE>
DIAGNON CORPORATION AND SUBSIDIARIES
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UNAUDITED STATEMENTS OF CONSOLIDATED CASH FLOWS FOR THE
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SIX MONTHS ENDED NOVEMBER 30, 1997 AND NOVEMBER 30, 1996
- --------------------------------------------------------
<TABLE>
<CAPTION>
Six Months Ended Six Months Ended
November 30, 1997 November 30, 1996
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<S> <C>
CASH FLOWS FROM OPERATING ACTIVITIES:
Net (Loss)/Income $ (70,035) $ 46,126
--------------- ---------------
Adjustments to reconcile net (loss) income to net cash provided by (used for)
operating activities:
Depreciation and amortization 143,241 122,925
Deferred income taxes (40,400) 15,000
Decrease in accounts receivable 409,984 22,926
Increase in prepaid expenses (25,658) (58,322)
Increase in inventories (11,427) (394)
Decrease (increase) in other assets 54,000 (15,000)
Decrease in accounts payable and accrued expenses (55,044) (150,709)
Increase in income taxes payable 1,100 10,100
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Total adjustments 475,796 (53,474)
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NET CASH PROVIDED BY (USED FOR) OPERATING ACTIVITIES 405,761 (7,348)
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CASH FLOWS USED FOR INVESTING ACTIVITIES:
Capital expenditures (135,676) (151,126)
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NET CASH USED FOR INVESTING ACTIVITIES (135,676) (151,126)
--------------- ---------------
CASH FLOWS FROM FINANCING ACTIVITIES:
Net payments for fractional shares as a result of
1 to 6 share reverse stock split (511)
Net (payments) proceeds under line-of-credit agreement (207,376) 74,213
Principal payments under capital lease obligations (60,668) (55,213)
--------------- ---------------
NET CASH (USED FOR) PROVIDED BY FINANCING ACTIVITIES (268,555) 19,000
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NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS 1,530 (139,474)
CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD 62,638 218,543
--------------- ---------------
CASH AND CASH EQUIVALENTS AT END OF PERIOD $ 64,168 $ 79,069
=============== ===============
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION
Cash paid during the period for:
Interest $ 24,994 $ 22,283
=============== ===============
Income taxes $ 8,400 $ 6,200
=============== ===============
SUPPLEMENTAL SCHEDULE OF NONCASH INVESTING AND
FINANCING ACTIVITIES:
The Company issued:
Long-term debt issued in connection with capital
leases $ 110,040
===============
</TABLE>
See notes to financial statements.
5
<PAGE>
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.
Inventories
- -----------
Inventories are stated at the lower of cost or market.
Item 2. MANAGEMENT'S DISCUSSION AND ANALYSIS
Summary Analysis
- ----------------
In this second quarter of fiscal year 1998, Diagnon realized a net loss of
($71,021) totalling a net loss of ($70,035) for the first six months of fiscal
year 1998. The loss for the quarter and the first six months of this fiscal year
primarily resulting from one-time costs of $15,000 for the listing fee to the
Chicago Stock Exchange and $25,000 for the termination fee related to the tabled
private placement funding effort. Further contributing to the loss was
approximately $37,300 of applied indirect costs on two completed contracts which
caused the total incurred costs of each contract to exceed its funding. These
indirect costs are currently not available for reimbursement and therefore
revenue cannot be recognized. According to Federal Acquisition Regulations, the
Company may be able to recover all or part of these costs after a government
indirect cost audit for fiscal year 1998 has been completed.
During this quarter the following developments occurred:
o On September 30, 1997, the Company's subsidiary, BIOQUAL, Inc., was
awarded a National Cancer Institute (NCI) Small Business Innovation
Research (SBIR) Grant titled "Nonhuman Primate Model for Helicobacter
Pylori Infection". This six month grant totals $100,000.
o Also on September 30, 1997, BIOQUAL was awarded a National Institute of
Diabetes and Digestive and Kidney Diseases SBIR Grant titled
"Identification of Helicobacter pylori Protective Antigens". The six
month grant totals $99,673.
o On October 1, 1997, BIOQUAL was awarded and began work on the sole
source renewal of the NCI contract "Facility for Preparing and Housing
Virus Infected Mice, Genetically Manipulated Mice and Chimeric Mice".
This four year contract totals $3,161,223.
o On October 22, 1997, the Company's shareholders voted to effect a one
for six reverse stock split. This was a requirement to become listed on
the Chicago Stock Exchange. On October 23, 1997, the Company became
listed on the Chicago Stock Exchange.
o On November 1, 1997, BIOQUAL was awarded and began work on the sole
source renewal of the NCI contract "Maintenance of an Animal Holding
and Breeding Facility and Provision of Attendant Research Services".
This four year contract totals $4,066,252.
6
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o In light of the strengthened government business and the SBIR awards, a
cash flow analysis was prepared. This analysis prompted the Board of
Directors to decide to table the private placement funding effort under
consideration while continuing to review the cash needs of the Company
on a quarterly basis.
Results of Operations
- ---------------------
Three Months Comparison
- -----------------------
For the three months of operations ended November 30, 1997 (the Company's second
quarter), Contract Revenues increased by 3.5% due to increased contract
activity. Product Sales increased to $5,580 from $2,778 from the prior year
second quarter. Contract Operating Expenses increased 10.3% primarily due to 1)
increased contract activity, 2) increased fringe benefits expenses incurred in
fiscal year 1998, 3) increased costs associated with the production of the
Company's product, Lyphomune(R), and 4) approximately $37,300 of applied
indirect costs on two completed contracts which caused the total incurred costs
of each contract to exceed its funding. These indirect costs are currently not
available for reimbursement and therefore revenue cannot be recognized.
According to Federal Acquisition Regulations, the Company may be able to recover
all or part of these costs after a government indirect cost audit for fiscal
year 1998 has been completed. Cost of Goods Sold increased to $7,944 from $1,736
in the second quarter of FY97. This increase was primarily due to increased
sales of Lyphomune(R) during this quarter compared to the same quarter in FY97.
Research and Development (R&D) expenses increased to $91,305 compared to $87,818
in the second quarter of FY97. This increase was primarily due to increased
costs associated with the Company's ongoing Helicobacter pylori research
program. General and Administrative Expenses (G&A) increased 11.2% compared to
the prior year primarily due to a $25,000 fee for terminating the private
placement funding effort with Slusser Associates (SA) and a $15,000 fee for
listing on the Chicago Stock Exchange (CHX). Total Operating Expenses increased
10.5% primarily due to the above.
Operating Income decreased $148,059 to an operating loss of ($91,265) compared
to the prior year operating income of $56,794. This loss was primarily due to
the incurrence of the one-time costs mentioned above (the $25,000 SA termination
fee, the $15,000 CHX listing fee, and the $37,300 cost overrun on two contracts)
in addition to Operating Expenses increasing at a greater rate than Operating
Revenues and Product Sales.
For this quarter, Diagnon had interest expense of $12,537 compared to interest
expense of $11,054 in the second quarter of the prior year.
In accordance with SFAS No. 109, "Accounting for Income Taxes", the Company
reported a deferred federal income tax benefit of $40,950 for the three months
ended November 30, 1997. The Company provided for state income tax which is
estimated at $9,400. State income tax expense is reimbursable under
government contracting regulations.
For comparison purposes, all share and per share data in the financial
statements have been retroactively adjusted to reflect the one for six share
reverse stock split effected on October 22, 1997.
Six Months Comparison
- ---------------------
For the six months of operations ended November 30, 1997, Contract Revenues
7
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increased by 2.7% compared to the prior year primarily due to increased contract
activity. Product Sales increased to $6,653 from $3,858 from the first six
months of the prior year. Contract Operating Expenses increased 6.1% primarily
due to 1) increased contract activity, 2) increased fringe benefits expenses
incurred in fiscal year 1998, 3) increased costs associated with the production
of the Company's product, Lyphomune(R), and 4) approximately $37,300 of applied
indirect costs on two completed contracts which caused the total incurred costs
of each contract to exceed its funding. These indirect costs are currently not
available for reimbursement and therefore revenue cannot be recognized.
According to Federal Acquisition Regulations, the Company may be able to recover
all or part of these costs after a government indirect cost audit for fiscal
year 1998 has been completed. Cost of Goods Sold increased to $24,422 from
$2,356 through the first six months of the fiscal year. This increase was
primarily due to the expensing, from inventory, of 147 units of Lyphomune(R)
used in a sales promotion and increased sales during this fiscal year. General
and Administrative Expenses increased 4.0% compared to the prior year primarily
due to the $25,000 fee for terminating the private placement funding effort with
SA and the $15,000 fee for listing on the CHX as discussed in the Three Months
Comparison. Total Operating Expenses increased 6.8%, due to the above.
Operating Income decreased $175,549 to an operating loss of ($78,846) compared
to the prior year operating income of $96,703. This loss was primarily due to
the incurrence of the one-time costs mentioned above (the $25,000 SA termination
fee, the $15,000 CHX listing fee, and the $37,300 cost overrun on two contracts)
in addition to Operating Expenses increasing at a greater rate than Operating
Revenues and Product Sales.
For the six months of this fiscal year, Diagnon had interest expense of $24,658
compared to interest expense of $22,869 in the prior year.
In accordance with SFAS No. 109, "Accounting for Income Taxes", the Company
reported a deferred federal income tax benefit of $40,400 for the six months
ended November 30, 1997. The Company provided for state income tax which is
estimated at $9,500. State income tax expense is reimbursable under government
contracting regulations.
For comparison purposes, all share and per share data in the financial
statements have been retroactively adjusted to reflect the one for six share
reverse stock split effected on October 22, 1997.
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 decreased by
$409,984 primarily consisting of 1) a $369,350 decrease to Trade Receivables
reflecting a faster collection rate compared to the collection rate of at the
end of the previous fiscal year end, 2) a decrease of $13,697 to Unbilled
Accounts Receivable primarily due to the billing of $52,126 of previously
unbilled contract fee retention in November, offset by an increase of $39,743 in
reimbursable indirect rate variances for the first six months of fiscal year
1998, and 3) a $26,126 decrease to Other Accounts Receivable primarily due to
the collection of a prior year receivable from the Medical Center Drive facility
landlord. Other Noncurrent Assets decreased $54,000 due to the completion of a
nonhuman primate housing order from the previous
8
<PAGE>
fiscal year.
The decreases above were partially offset by 1) an increase in Prepaid Expenses
of $25,658 primarily due to the prepayment of real estate and personal property
taxes, and 2) an increase in Fixed Assets, net of Accumulated Depreciation and
Amortization, of $102,475 reflecting fixed asset purchases of $245,716 (mainly
nonhuman primate housing units and laboratory and production equipment) offset
by depreciation and amortization of $143,241 during this six month period. The
balance of the decrease is due to other miscellaneous factors.
Liabilities
In the first six months of operations, Total Liabilities decreased $211,948.
This decrease is primarily attributable to 1) a decrease in Borrowings Under
Line-of-Credit of $207,376 reflecting the collection of Trade Receivables, 2)
a $58,594 decrease to Accounts Payable, and 3) a decrease in Accrued
Compensation and Related Costs of $23,990.
The decreases above are partially offset by 1) an increase to Long-Term Debt of
$49,372 related to a capital lease of $110,040 for nonhuman primate housing
units at the Research Boulevard facility, offset by $60,668 of payments on
capital leases and 2) a $27,540 increase to Other Accrued Liabilities. The
balance of the decrease is due to other miscellaneous factors.
Stockholders' Equity
On October 22, 1997, the Company's shareholders affirmatively voted to effect a
reverse split of the shares of the Common Stock in which each six shares of
Common Stock became one share of Common Stock. The Company's Common Stock shares
decreased from 9,602,452 shares issued to 1,600,408 shares issued, outstanding
shares decreased from 5,398,244 shares to 899,505 shares, while the Treasury
stock decreased from 4,204,208 shares to 700,903 shares. Fractional shares, as a
result of the reverse split, were repurchased by the Company and recorded as
Treasury Stock.
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 1. LEGAL PROCEEDINGS
On September 3, 1997 Lourdes Weisgerber, a former employee, filed a Complaint in
The United States District Court for the District of Maryland (Southern
Division) Case No. PJM 972970 alleging that BIOQUAL, Inc. violated her
employment rights under the Americans With Disabilities Act. This allegation was
previously reported as an administrative law matter within the Equal Employment
Opportunity Commission (EEOC) and the Montgomery County Human Relations
Commission. The investigation conducted by the Montgomery County Human Relations
Commission found no discrimination. Ms. Weisgerber asked for and received a
Notice of Right to Sue upon the dismissal of the administrative complaint by
Montgomery County and the EEOC. The Plaintiff has sued for backpay, emotional
distress, pain and suffering, punitive damages, and attorneys' fees and costs.
While the Company intends to defend
9
<PAGE>
this action vigorously and believes that it will not have a material effect on
its financial condition, it can not give any assurance of the results of this
pending litigation.
Item 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
Annual Meeting - October 22, 1997
Election of Directors
Four directors were elected:
For Withheld
--------- --------
J. Thomas August, M.D. 3,484,732 3,815
Charles C. Francisco 3,485,532 3,015
Charles F. Gauvin 3,485,532 3,015
John C. Landon, Ph.D. 3,484,732 3,815
There were no other directors whose term of office as a director continued after
the meeting.
Other Matters Voted Upon at the Meeting
Proposal 2 To approve the appointment of Deloitte & Touche LLP as
independent public accountants for the Company.
Affirmative Votes 3,486,497
Negative Votes 1,200
Abstain 400
Proposal 3 To amend the Company's 1988 Stock Option Plan.
Affirmative Votes 3,471,542
Negative Votes 16,405
Abstain 600
Proposal 4 To adopt a new stock option plan.
Affirmative Votes 3,337,492
Negative Votes 150,455
Abstain 600
Proposal 5 To amend the Certificate of Incorporation to authorize,
ratify, and approve the issuance of 17,390 shares of Common Stock.
Affirmative Votes 3,466,442
Negative Votes 19,855
Abstain 2,250
Proposal 6 To amend and restate the Certificate of Incorporation (i)
to eliminate the authorization to issue 325,000 shares of Convertible
Preferred Stock, all of which was previously issued and converted to
Common Stock, and (ii) to authorize the issuance of 500,000 shares of
new Preferred Stock.
Affirmative Votes 3,102,402
Negative Votes 383,895
Abstain 2,250
10
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Proposal 7 To amend and restate the Certificate of Incorporation (i)
to effect a reverse split of the shares of the Common Stock in which
each six shares of Common Stock shall become one share of Common Stock,
and (ii) to establish the number of authorized shares of Common Stock
at 25,000,000.
Affirmative Votes 3,338,762
Negative Votes 147,735
Abstain 2,050
Item 6. EXHIBITS
Exhibits filed
--------------
(10) (a) Government Contracts.
--------------------
1. Title: Maintenance of an Animal Holding and
Breeding Facility and Provision of
Attendant Research Services.
Institute: National Cancer Institute
Dates Funded: 11/1/97 - 10/31/01
(b) The Company's 1998 Stock Option Plan, adopted October 22,
1997.
Exhibits incorporated by reference to the Company's FORM 8-A filed
------------------------------------------------------------------
on October 22, 1997.
--------------------
(3) (i) Second Amended and Restated Certificate of Incorporation
dated October 22, 1997.
11
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused the report to be signed on its behalf by the
undersigned thereunto duly authorized.
DIAGNON CORPORATION
DATE January 13, 1998 /s/ John C. Landon
-------------------- --------------------------------
Chairman of the Board,
President and Chief Executive
Officer
DATE January 13, 1998 /s/ Michael P. O'Flaherty
-------------------- --------------------------------
Chief Operating Officer and
Secretary
DATE January 13, 1998 /s/ David A. Newcomer
-------------------- --------------------------------
Chief Financial Officer
12
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EXHIBITS
(10) (a) Government Contracts.
1. Title: Maintenance of an Animal
Holding and Breeding
Facility and Provision
of Attendant Research
Services.
Institute: National Cancer Institute
Dates Funded: 11/1/97 - 10/31/01
<PAGE>
<TABLE>
<S><C>
OMB NO. 0990-0115
====================================================================================================================================
1. THIS CONTRACT IS A RATED ORDER RATING PAGE OF PAGES
AWARD/CONTRACT UNDER DPAS (15 CFR 350) 1 26
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2. CONTRACT (Proc. Inst Ident.) NO. 3. EFFECTIVE DATE 4. REQUISITION PURCHASE REQUEST/PROJECT NO.
N02-BC-81040 11/01/97
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5. ISSUED BY CODE 261981041 6. ADMINISTERED BY (If other than item 5) CODE
------------------ --------------------
National Cancer Institute Experimental Immunology
Research Contracts Branch, CECS
Executive Plaza South, Room 620
9000 Rockville Pike MSC 7224 Division of Basic Sciences
Bethesda Maryland 20892-7224 (RFP No. N02BC71040-21)
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7. NAME AND ADDRESS OF THE CONTRACTOR (No., street, city, county, State and ZIP Code) 8. DELIVERY
[X] FOB Destination [ ] FOB Origin
Bioqual, Inc. ----------------------------------------
9600 Medical Center Drive 9. DISCOUNT FOR PROMPT PAYMENT
Rockville, Maryland 20850-3336
----------------------------------------
10. SUBMIT INVOICES ITEM
(4 copies unless otherwise
specified)
PLACE OF PERFORMANCE: Rockville, Maryland TO THE ADDRESS SHOWN IN
- ------------------------------------------------------------------------------------------- SEE SECTION G
CODE FACILITY CODE (RIGHT ARROW) ARTICLE G.3.
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11. SHIP TO/MARK FOR CODE 12. PAYMENT WILL BE MADE BY CODE
SEE SECTION F, ARTICLE F.1. SEE SECTION G, ARTICLE G.3. --------------------------
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13. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION 14. ACCOUNTING AND APPROPRIATION DATA
CAN1 88322363 TIN 1521244771A1
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[ ] 10 U.S.C. 2304(c) ( ) [X] 41 U.S.C. 253(c) (1) CAN2 DOC NO. N2BC81040A
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OC CODE 25.2E LOC
---------------- ---------------
- ------------------------------------------------------------------------------------------------------------------------------------
15A. ITEM NO. 15B. SUPPLIES/SERVICES 15C. QUANTITY 15D. UNIT 15E. UNIT PRICE 15F. AMOUNT
- ------------------------------------------------------------------------------------------------------------------------------------
TITLE: Maintenance of an Animal Holding and Breeding Facility and Provision of Attendant CAN1: $ 958,535
Research Services CAN2: $
-----------------
CURRENT OBLIGATION: $ 958,535
CONTRACT PERIOD: 11/01/97 through 10/31/98 $
CONTRACT TYPE: Cost-Plus Fixed Fee, TERM $
- ------------------------------------------------------------------------------------------------------------------------------------
15G. TOTAL AMOUNT OF CONTRACT $ 958,535
- ------------------------------------------------------------------------------------------------------------------------------------
16. TABLE OF CONTENTS
- ------------------------------------------------------------------------------------------------------------------------------------
(X) SEC. DESCRIPTION PAGE(S) (X) SEC. DESCRIPTION PAGE(S)
- ------------------------------------------------------------------------------------------------------------------------------------
PART I--THE SCHEDULE PART II--CONTRACT CLAUSES
- ------------------------------------------------------------------------------------------------------------------------------------
X A SOLICITATION/CONTRACT FORM 4 X I CONTRACT CLAUSES 20
- ------------------------------------------------------------------------------------------------------------------------------------
X B SUPPLIES OF SERVICES AND PRICES/COSTS 4 PART III--LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH
- ------------------------------------------------------------------------------------------------------------------------------------
X C DESCRIPTION/SPECS./WORK STATEMENT 6 X J LIST OF ATTACHMENTS 26
- ------------------------------------------------------------------------------------------------------------------------------------
X D PACKAGING AND MARKING 12 PART IV--REPRESENTATIONS AND INSTRUCTIONS
- ------------------------------------------------------------------------------------------------------------------------------------
X E INSPECTION AND ACCEPTANCE 12 REPRESENTATIONS, CERTIFICATIONS AND
- ----------------------------------------------------------------- X K 26
X F DELIVERIES OR PERFORMANCE 13 OTHER STATEMENTS OF OFFERORS
- ------------------------------------------------------------------------------------------------------------------------------------
X G CONTRACT ADMINISTRATION DATA 15 [ ] L INSTRS., CONDS., AND NOTICES TO OFFERORS
- ------------------------------------------------------------------------------------------------------------------------------------
X H SPECIAL CONTRACT REQUIREMENTS 18 [ ] M EVALUATION FACTORS FOR AWARD
- ------------------------------------------------------------------------------------------------------------------------------------
CONTRACTING OFFICER WILL COMPLETE ITEM 17 OR 18 AS APPLICABLE
- ------------------------------------------------------------------------------------------------------------------------------------
17. [X] CONTRACTORS NEGOTIATED AGREEMENT (Contractor is required 18. [ ] AWARD (Contractor is not required to sign this
to sign this document and return 1 copies to issuing office.) document.)
Contractor agrees to furnish and deliver all items or perform all Your offer on Solicitation Number ________________________
the services set forth or otherwise identified above and on any including the additions or changes made by you which
continuation sheets for the consideration stated herein. The rights additions or changes are set forth in full above, is herein
and obligations of the parties to this contract shall be subject to accepted as to the items listed above and on any continu-
and governed by the following documents: (a) this award/contract, ation sheets. This award consummates the contract which
(b) the solicitation, if any, and (c) such provisions, representations, consists of the following documents: (a) the Government's
certifications, specifications, as are attached or incorporated by solicitation and your offer and (b) this award/contract.
reference herein. (Attachments are listed herein.) No further contractual document is necessary.
- ------------------------------------------------------------------------------------------------------------------------------------
19A. NAME AND TITLE OF SIGNER (Type or print) 20A. NAME OF CONTRACTING OFFICER
/s/ Michael P. O'Flaherty COO BARBARA A. SHADRICK
- ------------------------------------------------------------------------------------------------------------------------------------
19B. NAME OF CONTRACTOR 19C. DATE SIGNED 20B. UNITED STATES OF AMERICA 20C. DATE SIGNED
BY /s/ Michael P. O'Flaherty 10/31/97 BY /s/ Barbara A. Shadrick 10/31/97
-------------------------- --------------------------
(Signature of person (Signature of Contracting
authorized to sign) Officer)
- ------------------------------------------------------------------------------------------------------------------------------------
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>
Contract No. N02-BC-81040
Page 2
DETAILED TABLE OF CONTRACT CONTENTS
-----------------------------------
PART I - THE SCHEDULE
SECTION A - SOLICITATION/CONTRACT FORM
SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS.....................4
ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES.......4
ARTICLE B.2. ESTIMATED COST AND FIXED FEE....................4
ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS...........5
ARTICLE B.4. ADVANCE UNDERSTANDINGS..........................5
SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT.................6
ARTICLE C.1. STATEMENT OF WORK...............................6
ARTICLE C.2. REPORTING REQUIREMENTS.........................11
SECTION D - PACKAGING, MARKING AND SHIPPING..........................12
SECTION E - INSPECTION AND ACCEPTANCE................................12
SECTION F - DELIVERIES...............................................13
SECTION G - CONTRACT ADMINISTRATION DATA.............................15
ARTICLE G.1. PROJECT OFFICER................................15
ARTICLE G.2. KEY PERSONNEL..................................15
ARTICLE G.3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST
AND CONTRACT FINANCIAL REPORT................15
ARTICLE G.4. INDIRECT COST RATES........................................17
ARTICLE G.5. GOVERNMENT PROPERTY........................................17
ARTICLE G.6. POST AWARD EVALUATION OF PAST PERFORMANCE..................18
SECTION H - SPECIAL CONTRACT REQUIREMENTS............................18
ARTICLE H.1. REIMBURSEMENT OF COSTS FOR INDEPENDENT RESEARCH
AND DEVELOPMENT PROJECTS.....................18
ARTICLE H.2. HUMAN SUBJECTS.................................18
ARTICLE H.3. INTRODUCTION OF RODENTS AND RODENT PRODUCTS....18
ARTICLE H.4. ANIMAL WELFARE ASSURANCE.......................18
ARTICLE H.5. OPTION PROVISION...............................19
ARTICLE H.6. REPORTING MATTERS INVOLVING FRAUD, WASTE AND
ABUSE........................................19
<PAGE>
Contract No. N02-BC-81040
Page 3
PART II - CONTRACT CLAUSES....................................................20
SECTION I - CONTRACT CLAUSES............................................20
ARTICLE I.1. GENERAL CLAUSES FOR A COST-REIMBURSEMENT SERVICE
CONTRACT..........................................20
PART III......................................................................26
SECTION J - LIST OF ATTACHMENTS.........................................26
1. Invoice/Financing Request and Contract Financial Reporting
Instructions for NIH Cost-Reimbursement Type Contracts.....26
2. Safety and Health............................................26
3. Procurement of Certain Equipment.............................26
4. Government Property - Schedule II-A..........................26
5 Pathology Report.............................................26
6. Animal Health Diagnostic Serology Submission Form............26
7. Animal Health Diagnostic Request Form........................26
8. Introduction of Rodents and Rodent Products,
NIH Manual 3043-1..........................................26
9. Application for Permit to Introduce Rodent and
Rodent Produce, NIH 2369-1.................................26
10. Permit to Introduce Rodents and Rodent Products,
NIH 2369-2.................................................26
11. Material Transfer Agreement..................................26
12. Animal Inventory and Breeding Record Sheet...................26
13. Animal Inventory Summary.....................................26
14. Animal Mortality Sheet.......................................26
PART IV.......................................................................26
SECTION K - REPRESENTATIONS AND CERTIFICATIONS..........................26
Representations and Certifications...............................26
Animal Welfare Assurance Number..................................26
<PAGE>
Contract No. N02-BC-81040
Page 4
SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS
- -------------------------------------------------
ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES
- ------------------------------------------------------
The Contractor shall provide an animal facility which shall be capable of: (1)
maintaining a colony of mice to support ongoing research in the areas of
immunobiology, immunogenetics, tumor biology and diagnosis and transplantation;
(2) breeding special strains of mice; and (3) providing a technical staff to
perform animal manipulations; and (4) maintaining a freezer bank if biologic
products. All animals will be supplied by the Government except sentinel mice.
This service is being provided for the Experimental Immunology Branch, Division
of Basic Sciences, National Cancer Institute.
ARTICLE B.2. ESTIMATED COST AND FIXED FEE
a. The estimated cost of the base year of this contract is $895,827.
b. The fixed fee for the base year of this contract is $62,708. The fixed fee
shall be paid in installments based on the percentage of completion of
work, as determined by the Contracting Officer, and subject to the
withholding provisions of the clauses ALLOWABLE COST AND PAYMENT and FIXED
FEE referenced in the General Clause Listing in Part II, ARTICLE I.1. of
this contract. Payment of fixed fee shall not be made in less than monthly
increments.
c. The Government's obligation, represented by the sum of the estimated cost
plus the fixed fee for the base year of this contract is $958,535.
d. If the Government exercises its option pursuant to ARTICLE H.5. of this
contract, the Government's obligation represented by the sum of the
estimated cost plus the fixed fee of this contract will be increased as
follows:
<TABLE>
<CAPTION>
Estimated Cost Effective
Option Period Estimated Cost Fixed Fee Plus Fixed Fee Date
------------- -------------- --------- -------------- ---------
<S> <C>
Option 1 (12 months) $ 931,517 $ 65,206 $ 996,723 11/01/1998
Option 2 (12 months) $ 967,633 $ 67,734 $1,035,367 11/01/1999
Option 3 (6 months) $ 495,162 $ 34,661 $ 529,823 11/01/2000
Option 4 (6 months) $ 510,097 $ 35,707 $ 545,804 05/01/2001
--------- -------- ----------
TOTAL $2,954,414 $206,809 $4,066,252
(Including Base Year)
</TABLE>
e. Total funds currently available for payment and allotted to this contract
are $958,535 of which $895,827 represents the estimated costs, and of
which $62,708 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.
f. It is estimated that the amount currently allotted will cover performance
of the contract through October 31, 1998.
g. The Contracting Officer may allot additional funds to the contract without
the concurrence of the Contractor.
<PAGE>
Contract No. N02-BC-81040
Page 5
ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS
- --------------------------------------------------
a. Items Unallowable Unless Otherwise Provided
-------------------------------------------
Notwithstanding the clauses, ALLOWABLE COST AND PAYMENT and FIXED FEE,
incorporated in this contract by reference, unless authorized in writing
by the Contracting Officer, the costs of the following items or activities
shall be unallowable as direct costs:
(1) Acquisition, by purchase or lease, of any interest in real
property;
(2) Special rearrangement or alteration of facilities;
(3) Purchase or lease of any item of general purpose office furniture
or office equipment regardless of dollar value. (General purpose
equipment is defined as any items of personal property which are
usable for purposes other than research, such as office equipment
and furnishings, pocket calculators, etc.). All requests for
computer equipment shall be screened to ensure compliance with EPA
Energy Star requirements.
(4) Travel to attend general scientific meetings;
(5) Foreign travel - (Not applicable)
(6) Patient care costs;
(7) Accountable Government property (defined as both real and personal
property with an acquisition cost of $1,000 or more and a life
expectancy of more than two years) and "sensitive items" (defined
and listed in the Contractor's Guide for Control of Government
Property) 1990, regardless of acquisition value.
(8) Consultants; and
(9) Subcontracts.
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 for the animal caretaker staff not to exceed a
total of:
Base Year: $2,202 (effective 11/01/1997)
Option 1: $2,289 (effective 11/01/1998)
Option 2: $2,375 (effective 11/01/1999)
Option 3: $1,213 (effective 11/01/2000)
Option 4: $1,249 (effective 05/01/2001)
------
Total (not to exceed): $9,328
<PAGE>
Contract No. N02-BC-81041
Page 6
b. Consultants
-----------
Consultant fee to be paid to the following individual:
<TABLE>
<CAPTION>
Total Cost
Rate Number of Including Travel Effective
Name Per Hour Hours Not to Exceed Period Date
---- -------- ----- ------------- ------ ----
<S> <C>
Robert J. Russell, DVM $60.00 104 $ 6,240 Base Year 11/01/1997
$60.00 104 $ 6,240 Option 1 11/01/1998
$60.00 104 $ 6,240 Option 2 11/01/1999
$60.00 52 $ 3,120 Option 3 11/01/2000
$60.00 52 $ 3,120 Option 4 05/01/2001
--- -------
Totals (not to exceed): 416 $24,960
</TABLE>
SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT
- -----------------------------------------------------
ARTICLE C.1. STATEMENT OF WORK
- ------------------------------
Independently and not as an agent of the Government, the Contractor shall
furnish all the necessary services, qualified personnel, material, equipment,
and facilities, not otherwise provided by the Government as needed to perform
the Statement of Work below:
a. Animal Maintenance
------------------
1) The Contractor shall supply animal care and maintenance for
approximately 7,500 - 10,000 mice, 40 rabbits, 50 rats and 50
hamsters according to standards outlined in the Guide for the Care
and Use of Laboratory Animals as published in DHHS Publication No.
(NIH 86-23), the Public Health Service Policy on Humane Care and Use
of Laboratory Animals (September 1986) and the Animal Welfare Act in
1976 and amendments thereto. The animals shall be maintained in a
multi-roomed facility that shall include separate rooms for this
contract for holding: a) stock mice, b) rabbits, c) rats and
hamsters, d) mice used for breeding purposes and e) quarantined
mice. The quarantine room shall have microisolator cages and a hood
for changing these cages. The size and number of rooms for the
animal categories described above shall be adequate to prevent
overcrowding.
2) The Contractor shall test for common pathogens in the rodents. The
mice shall be maintained as a conventional colony, rather than as
specific pathogen free. Routine screening of all mice in the colony
shall be performed at three-month or more frequent intervals, as
follows:
a) Sentinel mice, provided by the Contractor, shall be used to
screen for viral and bacterial pathogens, ova and parasites,
mites, pinworms, Giardia and mycoplasma.
b) Rat and hamster sentinels shall be used to detect serious
infections among those animals.
c) Sentinel animals shall be submitted in accordance with
SECTION F - DELIVERIES for testing described in 2)a), above.
Test results from the NCI will be provided to the Contractor.
<PAGE>
Contract No. N02-BC-81040
Page 7
d) The Contractor shall submit to the Project Officer the test
results from sentinel animals in accordance with the delivery
schedule. The Contractor shall provide the Project Officer
with the results of all autopsies or other diagnostic tests
performed. Autopsy and test results shall be submitted in the
format specified in Pathology Report (ATTACHMENT 5), Animal
Health Diagnostic Serology Submission Form (ATTACHMENT 6) and
Animal Diagnostic Request Form (ATTACHMENT 7).
e) The Contractor shall notify the Project Officer, within 72
hours, of any animals exhibiting disease.
3) The Contractor shall submit all diseased animals identified within
the holding colony in accordance with SECTION F - DELIVERIES. The
NCI will be responsible for performing autopsies and carrying out
pathologic examinations of tissues in order to determine the basis
for the disease. Results of the autopsies and pathologic
examinations will be provided by NCI to the Contractor.
4) The Contractor shall follow the procedures listed below for
introducing new mice from non-approved sources into the colony.
Animals entering the colony from approved sources shall not require
quarantine. A current list of approved sources shall be provided
from time to time by the Project Officer. The Contractor shall
comply with the policies stated in NIH Manual Chapter 3043-1,
Introduction of Rodents and Rodent Products, incorporated herein as
ATTACHMENT 8.
a) The Contractor shall obtain a history of all incoming mice
prior to admission to the quarantine facility. Mice coming
from outside facilities with a history of ectromelia,
lymphocytic choriomeningitis or other serious infections
shall not be admitted.
b) Mice from non-approved sources shall be maintained in micro
isolators in a room used only for mouse quarantine. The mice
shall be in contact with sentinel mice through the use of
mixed bedding. Mice shall be maintained in quarantine for a
sufficient period to ensure the absence of infection with
ectromelia and lymphocytic choriomeningitis and to evaluate
their potential disease status before they are placed in the
holding rooms. Sentinel mice shall be submitted to the NCI in
accordance with SECTION F - DELIVERIES for the above testing.
Test results from the NCI will be provided to the Contractor.
c) Technicians working with the quarantined mice shall wear a
gown, gloves and foot coverings and shall not enter any rooms
in the conventional colony after working in the quarantine
facility on that day.
d) No mice shall be introduced into the colony without the
specific approval of the Project Officer.
5) Maintenance requirements:
a) All animal care and laboratory personnel shall change into
clean lab clothing (including shirt, pants and shoes) upon
entering the facility, prior to performing assigned tasks.
Gloves and face masks must be worn by all Contractor staff
when handling animals. In the event of disease outbreak,
disposable gowns, shoe covers, bouffant caps, gloves and face
masks shall be worn by all employees working in the infected
area. The Contractor shall take precautions, approved by the
Project Officer, to avoid contamination of mice in the colony
with diseases from any other animals maintained by the
Contractor.
b) Feed shall be a standard ration for particular species as
prepared by a reputable commercial company, unless other
arrangements are made with the Project Officer.
<PAGE>
Contract No. N02-BC-81040
Page 8
c) The Contractor shall discard old feed in animal cages no less
than once a week.
d) The Contractor shall thoroughly wash all cages, racks and
feeding apparatuses at least once a week, using appropriate
detergents and water at no less than 180 degrees Fahrenheit.
The watering apparatus shall be washed twice a week using
appropriate detergents and water at no less than 180 degrees
Fahrenheit.
e) The Contractor shall mop all animal rooms and hallways daily.
The mop head shall be changed at least once a month.
f) The Contractor shall wash each animal room every month
according to the following procedures:
(1) All equipment shall be moved out of the room into the
central corridor and the floor swept thoroughly.
(2) Ceilings and walls shall be washed using an
appropriate cleaning solution.
(3) Ceilings and walls shall be rinsed thoroughly with
clean water.
(4) Excess water shall be removed from the floors.
(5) An appropriate disinfectant shall be applied to the
ceilings and all walls, allowing the solution to dry
(SHALL NOT RINSE).
g) The ambient temperature of the colony shall be maintained
year round at 74 degrees +/- 3 degrees Fahrenheit with
monitored alarm system for temperatures above 85 degrees
Fahrenheit. The Contractor shall maintain a plan for
immediate correction of ambient temperature outside the
specified range that is satisfactory to the Project Officer.
Relative humidity of the colony shall be maintained year
round at 50% +/- 10%.
h) Cage litter shall be changed at least once a week.
i) The ventilation system in each animal room shall provide for
a minimum of 10 air changes per hour. The ventilation system
shall remove particulate and toxic gaseous contaminants from
recirculated air, if applicable.
j) Animal drinking water shall be acidified to six parts per
million (ppm) (pH 2.5-3.0) with Hydrochloric Acid.
k) Animal care supplies and feed shall not be stored in the
animal holding rooms of the colony.
6) Shipping:
a) The Contractor shall provide, in accordance with the delivery
schedule, for the rapid exchange of animals and reagents
between the Contractor's facility and the Experimental
Immunology Branch (EIB) laboratories and animal facilities in
Building 10 on the National Institutes of Health (NIH)
campus, in a vehicle designed to maintain reasonable
temperature in summer and winter (75 degrees +/- 5 degrees
Fahrenheit). Reagents shall be shipped on wet ice, dry ice or
liquid nitrogen, as required by the Project Officer. Reagent
shipments shall not exceed the trip requirements for animals
and these shipments may be done simultaneously.
<PAGE>
Contract No. N02-BC-81040
Page 9
b) The Contractor shall provide two (2) trips per day, Monday
through Friday, except Government holidays, between the
colony and the EIB laboratories and animal facilities on the
NIH campus (Building 10, 9000 Rockville Pike, Bethesda,
Maryland 20892).
c) To meet requirements of the experiments, arrival times of the
shipments in a.7)b), above, will be specified by the Project
Officer, approximately 8:00 a.m. and 1:30 p.m. The Project
Officer may call in requests for animals or reagents as late
as 4:00 p.m. the day before a morning shipment or as late as
11:00 a.m. on the morning of an afternoon shipment.
d) The Contractor shall ship mice and reagents in accordance
with the delivery schedule to investigators outside of NIH at
the direction of the Project Officer. The cost of shipments
to other investigators shall be at the expense of the
recipient, unless specified otherwise by the Project Officer.
The Contractor shall process and maintain material transfer
agreements, incorporated herein as Exhibit 5, on shipments to
other investigators, as specified by the Project Officer.
Directions for shipping mice will be specified by the Project
Officer, such as the need to inform the recipient about the
health of the mice at the Contractor's facility prior to
shipment. The Contractor shall be responsible for
appropriately packing the shipments and arranging for
shipment from the Contractors facility. The Government will
pay for these shipments.
b. Mouse Breeding
--------------
1) The Contractor shall breed mice according to standard production
procedures, as opposed to pedigree breeding, as required by the
Project Officer. The Contractor shall maintain up to 300 - 500
cages of breeding mice and segregate offspring as required by the
Project Officer. These mice are included in the total listed in
paragraph a., above.
2) The Contractor shall collect tissues, as specified by the Project
Officer, within three working days of the request. The Contractor
shall pair mice for breeding at the direction of the Project
Officer. Mouse pairings requested for breeding shall be established
within seven calendar days of the Project Officer's request.
3) The Contractor shall carry gut special procedures as requested by
the Project Officer, including the use of microisolator cages for
breeding, setting up timed pregnancies, ear-tagging parents and
progeny, sacrificing progeny and collecting tail snips or
peripheral blood leukocytes.
4) The Contractor shall inspect cages at least three times a week. If
in any cage the production of lifters has stopped for a period of
two months, the cage shall be labeled as nonproductive and the
Project Officer shall be notified in writing or verbally within
seven calendar days.
C. Experimental Procedures
-----------------------
Perform experimental procedures as directed by the Project Officer,
including but not limited to the following:
1) Bleeding of mice (1,000).
2) Intra-peritoneal injections of mice (500).
3) Intravenous injections of mice (100).
4) Subcutaneous and/or footpad injections of mice (100).
<PAGE>
Contract No. N02-BC-81040
Page 10
5) Skin grafting of mice (30).
6) Taps of mouse ascites fluid (200).
7) Mouse tail snips collected and stored at or below -80 degrees Celsius
for DNA analysis at NIH (400).
8) Immunizations of rabbits (50).
9) Immunizations of rats (20).
10) Immunizations of hamsters (10).
11) Bleeding of rabbits (100).
12) Bleeding of rats (60).
13) Bleeding of hamsters (30).
14) Timed mouse pregnancies (200).
15) Mononuclear cell isolation from mouse peripheral blood by density
gradient centrifugation (400).
d. Bank of Biologic Products
-------------------------
1) The Contractor shall store sera and other biologic materials at
liquid/vapor phase liquid nitrogen temperature, at -80 degrees
Celsius, at -20 degrees Celsius, and at +4 degrees Celsius, as
designated by the Project Officer. The Contractor shall provide a
monitored alarm system for all freezers and refrigerators and a
plan for alarm response approved by the Project Officer. The
Contractor shall maintain a backup system that shall maintain
stored materials at the specified temperatures.
2) The Contractor shall maintain a record of the amount of
refrigeration and freezer space used by each of the 12 laboratories
in the EIB.
e. Laboratory Facilities
---------------------
The Contractor shall provide a laboratory area equipped with a bench and
sufficient area to house a sink, centrifuge and refrigerator.
f. Access - Meetings
-----------------
1) The Contractor shall provide ready access for Government
Investigators to monitor the animals and biologic reagents being
produced. Such access may often be several times per week.
2) The Contractor shall provide for frequent (at least once a week)
consultation between the Principal Investigator and the Project
Officer.
[END OF STATEMENT OF WORK]
<PAGE>
Contract No. N02-BC-81040
Page 11
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 SECTION F - DELIVERIES of this
contract:
1) Annual Progress Report
----------------------
This report shall:
a) provide a concise summary, not to exceed 200 words, or the
progress since the last reporting period;
b) contain a comprehensive report of progress during the last
one-year period including, as a minimum:
(1) the number of animals received;
(2) the number of animals disbursed;
(3) the number of mortalities;
(4) pertinent clinical data on animal tests and diseases;
c) proposed activity under the contract for the ensuing year.
Tables, graphs or other methods may be used to organize and
summarize data. The first report shall cover the period November 1,
1997 through October 31,1998, of this contract and shall be due
on/before the 30th of the month following the anniversary date of
the contract. Thereafter, reports shall be due on or before the
30th calendar day following each annual reporting period. If an
option is exercised, an Annual Progress Report will be required in
lieu of the Final Report. An Annual Progress Report will not be
required when the Final Report is due.
2) Annual Summary Progress Report
------------------------------
This report shall place emphasis on the accomplishments, including
as a minimum:
(a) the number of animals received and disbursed;
(b) the number of mortalities; and
(c) pertinent clinical data on animal tests and diseases.
The Project Officer reserves the right to request greater detail in
this report if deemed appropriate. The first report shall cover the
period November 1, 1997 through October 31,1998, of this contract
and shall be due on/before the 30th of the month following the
anniversary date of the contract. Thereafter, reports shall be due
on or before the 30th calendar day following each annual reporting
period. If an option is exercised, an Annual Summary Progress
Report will be required in lieu of the Final Report. An Annual
Summary Progress Report will not be required when the Final Report
is due.
<PAGE>
Contract No. N02-BC-81040
Page 12
3) Final Report
------------
This report is to include a summation of the work performed
and results obtained for the entire contract period of
performance. This report shall be in sufficient detail to
describe comprehensively the research and accomplishments and
the results achieved, covering the entire contract period,
including all applicable Option periods. The Final Report
shall be submitted in accordance with SECTION F - DELIVERIES
of this contract. The Final Report shall be due on/before the
expiration date of the contract, inclusive of all exercised
option periods. An Annual Progress Report and an Annual
Summary Progress Report will not be required for the period
when the Final Report is due.
b. Other Reports/Deliverables
--------------------------
1) Animal Inventory and Breeding Record Sheets
-------------------------------------------
Animal Inventory and Breeding Record Sheets shall contain an
individualized record for each of the up to 12 laboratories
in the Experimental Immunology Branch (EIB). The animal
inventory and breeding record sheets shall be delivered in
the format specified in ATTACHMENT 12. This report is to be
delivered only to the Project Officer (see SECTION F -
DELIVERIES, below).
2) Animal Inventory Summary
------------------------
The Animal Inventory Summary shall contain a summary of the
animal inventory and shall be delivered in the format
specified in ATTACHMENT 13. This report is to be delivered
only to the Project Officer (see SECTION F - DELIVERIES.,
below).
2) Animal Mortality Sheet
----------------------
The Animal Mortality Sheet shall contain data concerning the
mortality of animals within the colony and shall be delivered
in the format specified in ATTACHMENT 14. This report is to
be delivered only to the Project Officer (see SECTION F -
DELIVERIES, below).
SECTION D - PACKAGING, MARKING AND SHIPPING
- -------------------------------------------
All deliverables required under this contract shall be packaged, marked and
shipped in accordance with Government specifications. The Contractor shall
guarantee that all required materials shall be delivered in immediate usable and
acceptable condition.
SECTION E - INSPECTION AND ACCEPTANCE
- -------------------------------------
a. The Contracting Officer or the duly authorized representative will perform
inspection and acceptance of materials and services to be provided.
b. For the purpose of this ARTICLE, the Project Officer identified in ARTICLE
G. 1., below, is the authorized representative of the Contracting Officer.
c. Inspection and acceptance will be performed at Building 10, Room 4B17,
National Institutes of Health, Bethesda, Maryland.
Acceptance may be presumed unless otherwise indicated in writing by the
Contracting Officer or the duly authorized representative within 30 days
of receipt.
<PAGE>
Contract No. N02-BC-81040
Page 13
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 52.246-5, INSPECTION OF SERVICES-COST REIMBURSEMENT (APRIL 1984).
SECTION F - DELIVERIES
- ----------------------
Satisfactory performance of the final contract shall be deemed to occur upon
delivery and acceptance by the Contracting Officer, or the duly authorized
representative, of the following items in accordance with the stated delivery
schedule:
a. The items specified below as described in SECTION C. ARTICLE C.2. will be
required to be delivered F.O.B. Destination as set forth in FAR 52.247-35,
F.O.B. DESTINATION, WITHIN CONSIGNEES PREMISES (APRIL 1984), and in
accordance with and by the dates specified below and any specifications
stated in SECTION D. PACKAGING, MARKING AND SHIPPING, of the contract:
<TABLE>
<CAPTION>
Item Description Quantity Delivery Schedule
---- ----------- -------- -----------------
<S> <C>
1) Annual Progress Report Original - C.O. 30 calendar days after
specified in ARTICLE C.2. 3 Copies - P.O. each reporting period.
2) Annual Summary Progress Original - C.O. 30 calendar days after
Report specified in 3 Copies - P.O. each reporting period.
ARTICLE C.2.
3) Final Report specified Original - C.O. On/before the completion
in ARTICLE C.2. 3 Copies - P.O. date of contract.
4) Sentinel Animals and As required. As directed by the
diseased animals specified Project Officer.
in ARTICLE C.l., paragraphs
a.2)a) thru a.2)c).
5) Test Results from Sentinel 1 Copy of Within 7 calendar days
animals as specified in required form of performance.
ARTICLE C.1., para. a.2)d).
Utilize forms provided as
ATTACHMENTS 5, 6 & 7.
6) Animal Inventory and Breeding 2 Copies - P.O. First report is due 7
Record Sheets as specified calendar days after the
in ARTICLE C.2., effective date of the
paragraph b.1). Utilize form contract and every 7
provided as ATTACHMENT 12. calendar days thereafter.
7) Animal Inventory Summary 2 Copies - P.O. First report is due 7
specified in ARTICLE C.2., calendar days after the
paragraph b.2). Utilize form effective date of the
provided as ATTACHMENT 13. contract and every 7
calendar days thereafter.
</TABLE>
<PAGE>
Contract No. N02-BC-81040
Page 14
<TABLE>
<CAPTION>
Item Description Quantity Delivery Schedule
---- ----------- -------- -----------------
<S> <C>
8) Animal Mortality List 1 Copy - P.O. First report is due 7
specified in ARTICLE C.2., calendar days after the
paragraph b.3). Utilize form Effective date of the
provided as ATTACHMENT 14. contract and every 7
calendar days thereafter.
9) Animals and Reagents As directed by 2 per day as specified
specified in ARTICLE C.1., the P.O. in ARTICLE C.1.,
paragraph a.6)a). paragraph a.7)a).
10) Animals and Reagents As directed by the Project Officer.
specified in ARTICLE C.1.,
paragraph a.6)d).
</TABLE>
b. The above items shall be addressed and delivered to:
Originals only of Items 1), 2) and 3), above, shall be addressed and
delivered to:
Contracting Officer
Cancer Epidemiology Contracts Section
Research Contracts Branch, OEM
National Cancer Institute
Executive Plaza South, Room 620
6120 Executive Boulevard, MSC 7224
Bethesda, MD 20892-7224
The specified number of copies of Items 1), 2), 3), 5), 6), 7), 8), 9) and
10), above, shall be delivered to:
Project Officer (as identified in Article G. 1.)
Experimental Immunology Branch
Division of Basic Sciences
National Cancer Institute
Building 10, Room 4B17
9000 Rockville Pike, MSC 1360
Bethesda, MD 20892-1360
Item 4), above, shall be delivered to:
Senior Manager for Technical Operations
Animal Health Diagnostic Laboratory
PRI, Inc.
Frederick Cancer Research and Development Center (FCRDC)
Post Office Box B
Frederick, MD 21702-1201
<PAGE>
Contract No. N02-BC-81040
Page 15
SECTION G - CONTRACT ADMINISTRATION DATA
- ----------------------------------------
ARTICLE G.1. PROJECT OFFICER
- ----------------------------
The following Project Officer(s) will represent the Government for the purpose
of this contract:
Dr. Richard Hodes, 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 Contracting Officer hereby delegates the Project Officer as the Contracting
Officer's authorized representative responsible for signing software license
agreements issued as a result of this contract.]
The Government may unilaterally change its Project Officer designation.
ARTICLE G.2. KEY PERSONNEL
- --------------------------
Pursuant to the Key Personnel clause incorporated in this contract, the
following individual(s) is/are considered to be essential to the work being
performed hereunder:
NAME TITLE
---- -----
Leanne DeNenno Co-Project Manager
Genevieve Sanchez Co-Project Manager
ARTICLE G.3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT
- -----------------------------------------------------------------------
FINANCIAL REPORT
- ----------------
a. Invoice/Financing Request Instructions and Contract Financial Reporting
for NIH Cost-Reimbursement Type Contracts NIH(RC)-4 are attached and made
part of this contract. The instructions and the following directions for
the submission of invoices/financing request must be followed to meet the
requirements of a "proper" payment request pursuant to FAR 32.9.
b. These instructions also provide for the submission of financial and
personnel reporting required by HHSAR 342.7002. Unless otherwise stated in
that part of the Instructions for Completing Form NIH(RC)-4 (see
ATTACHMENT 1), all columns A through H shall be completed for each invoice
submitted.
c. The Contracting Officer may require the Contractor to submit detailed
support for costs contained in one or more interim financial invoices.
This clause does not supersede the record retention requirements of FAR
Part 4.7.
<PAGE>
Contract No. N02-BC-81040
Page 16
d. The contractor agrees to provide a detailed breakdown on invoices of cost
and personnel reporting and variances from the negotiated budget in the
following cost categories:
1) Direct Labor - List individuals by name, title/position,
hourly/annual rate, level of effort, and amount
claimed.
2) Fringe Benefits
3) Sentinel Animals
4) Laundry/Clothing
5) Cleaning Supplies
6) Animal Housing
7) Laboratory and Technician Supplies
8) Media and Reagents
9) Overtime Premium
10) Transportation
11) Equipment Maintenance
12) Consultant Veterinarian
13) Total Direct Costs
14) Overhead
15) Total Direct Cost plus Overhead
16) G&A
17) Total Cost
18) Fixed Fee
19) Total Amount Claimed (CPFF)
20) Adjustments
21) Grand Total
e. Invoices must include the cumulative total expenses to date, adjusted (as
applicable) to reflect any amounts suspended by the Government.
f. The Contractor agrees to immediately notify the Contracting Officer, in
writing, if there is an anticipated overrun (any amount) or unexpended
balance (greater than 10 percent) of the amount currently allotted to the
contract and the reasons for the variance. Also, refer to the requirements
of FAR 52.232-20, Limitation of Cost, referenced in the contract.
g. Invoices/financing requests shall be submitted in the form of an original
and two copies to the following designated billing office:
Contracting Officer
Cancer Epidemiology Contracts Section
Research Contracts Branch, OEM
National Cancer Institute, NIH
Executive Plaza South (EPS), Room 620
6120 EXECUTIVE BLVD MSC 7224
BETHESDA MD 20892-7224
h. Inquiries regarding approval of invoices should be directed to the
designated billing office, (301) 496-8611.
i. Inquiries regarding actual payment of invoices should be directed to the
designated payment office, (301) 496-6452.
<PAGE>
Contract No. N02-BC-81040
Page 17
ARTICLE G.4. INDIRECT COST RATES
- --------------------------------
In accordance with Federal Acquisition Regulation (FAR) (48 CFR Chapter 1)
Clause 52.216-7 (d)(2), Allowable Cost and Payment incorporated by reference in
this contract in Part II, Section I, the cognizant Contracting Officer
responsible for negotiating provisional and/or final indirect cost rates is
identified as follows:
Chief, Division of Financial Advisory Services
Office of Contract Management, OA
National Institutes of Health
6100 EXECUTIVE BLVD ROOM 6BO5 MSC 7540
BETHESDA MD 20892-7540
These rates are hereby incorporated without further action of the Contracting
Officer.
These rates are hereby incorporated without further action of the Contracting
Officer. The above information notwithstanding, the notifications required to be
submitted to the Contracting Officer pursuant to FAR 52.232-22, Limitation of
Funds, of this contract shall remain in effect.
ARTICLE G.5. GOVERNMENT PROPERTY
- --------------------------------
a. In addition to the requirements of the clause, GOVERNMENT PROPERTY,
incorporated in Section I of this contract, the Contractor shall comply
with the provisions of DHHS Publication, Contractor's Guide for Control of
Government Property, (1990), which is incorporated into this contract by
reference. Among other issues, this publication provides a summary of the
Contractor's responsibilities regarding purchasing authorizations and
inventory and reporting requirements under the contract. A copy of this
publication is available upon request to the Contract Property
Administrator.
This contracts Contract Property Administrator is:
David A. Hubbard, II
Contracts Property Administrator
Research Contracts Property Administration, NIH
Building 13, Room 2E-65
13 SOUTH DR MSC 5748
BETHESDA MD 20892-5748
(301) 496-6467
b. Government Furnished Property - Schedule II-A
---------------------------------------------
Pursuant to the clause, GOVERNMENT PROPERTY, incorporated in this
contract, the Contractor is hereby authorized to retain custody of the
property listed in Schedule II-A (ATTACHMENT 4) for use in direct
performance of this contract. Accountability for the items listed in
Schedule II-A is hereby transferred to this contract from predecessor
Contract No. N02-BC-40533, under which these items were provided by the
Government. Title to this property shall remain in the Government.
The property listed in Schedule II-A shall be dedicated 100% for use under
this contract.
<PAGE>
Contract No. N02-BC-81040
Page 18
ARTICLE G.6. POST AWARD EVALUATION OF PAST PERFORMANCE
- ------------------------------------------------------
Interim and final evaluations of contractor performance shall be conducted on
this contract in accordance with OFPP Policy Letter 92-5, issued January 11,
1993 and HHSAR 342.7002(c)(2)(iv). A final performance evaluation shall be
completed at the time of completion of work. In addition to the final
evaluation, interim evaluations will be prepared by the Project Officer annually
to coincide with the anniversary date of the contract.
Interim and final evaluations will be initiated by the Project Officer and
submitted to the Contracting Officer. The Contracting Officer will concur by
initialing the appropriate block of the NIH Contractor Performance Report, and
will submit the document to the Contractor as soon as practicable. The
Contractor will be permitted thirty days to review the document and to submit
additional information or a rebutting statement.
SECTION H - SPECIAL CONTRACT REQUIREMENTS
- -----------------------------------------
ARTICLE H.l. REIMBURSEMENT OF COSTS FOR INDEPENDENT RESEARCH AND DEVELOPMENT
- ----------------------------------------------------------------------------
PROJECTS
- --------
The primary purpose of the Public Health Service (PHS) is to support and advance
independent research within the scientific community. This support is provided
in the form of contracts and grants totaling approximately 7 billion dollars
annually. PHS has established effective, time tested and well recognized
procedures for stimulating and supporting this independent research by selecting
from multitudes of applications those research projects most worthy of support
within the constraints of its appropriations. The reimbursement through the
indirect cost mechanism of independent research and development costs not
incidental to product improvement would circumvent this competitive process.
To ensure that all research and development projects receive similar and equal
consideration, all organizations may compete for direct funding of independent
research and development projects they consider worthy of support by submitting
those projects to the appropriate Public Health Service grant office for review.
Since these projects may be submitted for direct funding, the Contractor agrees
that no costs for any independent research and development project, including
all applicable indirect costs, will be claimed under this contract.
ARTICLE H.2. HUMAN SUBJECTS
- ---------------------------
It is hereby understood and agreed that research involving human subjects shall
not be conducted under this contract, and that no material developed, modified,
or delivered by or to the Government under this contract, or any subsequent
modification of such material, shall 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. INTRODUCTION OF RODENTS AND RODENT PRODUCTS
- --------------------------------------------------------
No rodent or rodent product shall be delivered into the NIH, NCI environment
(NIH) directly, or through collaborative research or holding facilities under
contract to NCI except by permit. Direct shipments to NIH from a commercial
colony will be considered exempt. Non-exempt sources must be approved by permit
issued through the National Center for Research Resources (NCRR). The permit
must be obtained by the Contractor prior to the shipment to NIH of the rodents
and/or rodent products. The Contractor must be sure that this permit exists and
is current before transferring rodents or rodent products into the NIH, NCI
environment. Refusal or negligence to do so will be considered a material breach
of contract and may be treated as any other such material breach. Applications
for permits should be submitted not less than 30 days prior to shipping date to:
NIH Veterinary Resources Branch (VRP), National Center for Research Resources
(NCRR), Scientific Services Branch, Laboratory Sciences Section, Building 28A,
Room 11 1, 28 LIBRARY DR MSC 5210, BETHESDA MD 20892-5210, (301)496-4463.
<PAGE>
Contract No. N02-BC-81040
Page 19
ARTICLE H.4. ANIMAL WELFARE ASSURANCE
- -------------------------------------
The Contractor shall obtain, prior to the start of any work under this contract,
an approved Animal Welfare Assurance from the Office of Protection from Research
Risks (OPRR), Office of the Director, NIH, as required by Section 1-43-30 of the
Public Health Service Policy on Humane Care and Use of Laboratory Animals. The
Contractor shall maintain such assurance for the duration of this contract, and
any subcontractors performing work under this contract involving the use of
animals shall also obtain and maintain an approved Animal Welfare Assurance.
ARTICLE H.5. OPTION PROVISION
- -----------------------------
Unless the Government exercises its option pursuant to the Option Clause set
forth in ARTICLE I.3., the contract will consist only of the work required in
accordance with the Statement of Work, as defined in Sections C and F, for the
Base Year (Year 1) of the contract. Pursuant to FAR 52.217-9, set forth in
ARTICLE 1.3. of this contract, the Government may, by unilateral contract
modification, require the Contractor to perform the work required in accordance
with the Statement of Work, as defined in Sections C and F, for Options 1
through 4 (Years 2 through 4) of the of the contract. If the Government
exercises these options, notice must be given at least 60 days prior to the
expiration date of this contract, and the estimated cost plus fixed fee of the
contract will be increased as set forth in ARTICLE B.2.
ARTICLE H.6. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE
- ---------------------------------------------------------------
Anyone who becomes aware of the existence or apparent existence of fraud, waste
and abuse in NIH funded programs is encouraged to report such matters to the HHS
Inspector General's Office in writing or on the Inspector General's Hotline. The
toll free number is 1-800-HHS-TIPS (1-800-447-8477). All telephone calls will be
handled confidentially. The e-mail address is [email protected] and the mailing
address is:
Office of Inspector General
Department of Health and Human Services
TIPS HOTLINE
P.O. Box 23489
Washington, D.C. 20026
Information regarding procedural matters is contained in the NIH Manual Chapter
1754, which is available on (http://www1.od.nih.gov/oma/oma.htm)
<PAGE>
Contract No. N02-BC-81040
Page 20
PART II - CONTRACT CLAUSES
--------------------------
SECTION I - CONTRACT CLAUSES
- ----------------------------
ARTICLE I.1. GENERAL CLAUSES FOR A COST-REIMBURSEMENT SERVICE CONTRACT - CLAUSES
- ----------------------------------------------------------------------
INCORPORATED BY REFERENCE (APRIL 1984)
This contract incorporates the following clauses by reference, with the same
force and effect as if they were given in full text. Upon request, the
Contracting Officer will make their full text available [FAR52.252-2 (JUNE
1988)].
a. FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES:
FAR
CLAUSE NO. TITLE AND DATE
---------- --------------
52.202-1 Definitions (OCTOBER 1995)
52.203-3 Gratuities (Over $1 00,000) (APRIL 1984)
52.203-5 Covenant Against Contingent Fees (Over $100,000)
(APRIL 1984)
52.203-6 Restrictions on Subcontractor Sales to the Government
(Over $100,000) (JULY 1995)
52.203-7 Anti-Kickback Procedures (Over $100, 000) (JULY 1995)
52.203-8 Cancellation, Rescission, and Recovery of Funds for
Illegal or Improper Activity (Over $100,000)
(JANUARY 1997)
52.203-10 Price or Fee Adjustment for Illegal or Improper
Activity (Over $100,000) (JANUARY 1997)
52.203-12 Limitation on Payments to Influence Certain Federal
Transactions (Over $100,000) (JUNE 1997)
52.204-4 Printing/Copying Double-Sided on Recycled Paper
(Over $100,000) (JUNE 1996)
52.209-6 Protecting the Government's Interests when
Subcontracting with Contractors Debarred, Suspended,
or Proposed for Debarment (Over $25,000) (JULY 1995)
52.215-2 Audit and Records - Negotiation (Over $100,000)
(AUGUST 1996)
52.215-22 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)
(JANUARY 1997)
52.215-27 Termination of Defined Benefit Pension Plans
(MARCH 1996)
52.215-33 Order of Precedence (JANUARY 1986)
<PAGE>
Contract No. N02-BC-81040
Page 21
52.215-39 Reversion or Adjustment of Plans for Post-Retirement
Benefits other than Pensions (PRB) (MARCH 1996)
52.215-40 Notification of Ownership Changes (FEBRUARY 1995)
52.215-42 Requirements for Cost or Pricing Data or Information
Other Than Cost or Pricing Data--Modifications
(JANUARY 1997)
52.216-7 Allowable Cost and Payment (MARCH 1997)
52.216-8 Fixed Fee (MARCH 1997)
52.219-8 Utilization of Small, Small Disadvantaged, and
Women-Owned Small Business Concerns (Over $100,000)
(JUNE 1997)
52.219-9 Small, Small Disadvantaged, and Women-Owned Small
Business Subcontracting Plan (Over $500,000)
(AUGUST 1996)
52.219-16 Liquidated Damages - Subcontracting Plan
(Over $500,000) (OCTOBER 1995)
52.222-2 Payment for Overtime Premium (Over $100,000)
(JULY 1990) (NOTE: The dollar amount in
paragraph (a) of this clause is $0 unless
otherwise specified in the contract.)
52.222-3 Convict Labor (AUGUST 1996)
52.222-26 Equal Opportunity (APRIL 1984)
52.222-28 EEO Preaward Clearance of Subcontracts
(Over $1,000,000) (APRIL 1984)
52.222-35 Affirmative Action for Special Disabled and Vietnam
Era Veterans (APRIL 1984)
52.222-36 Affirmative Action for Handicapped Workers
(APRIL 1984)
52.222-37 Employment Reports on Special Disabled Veterans and
Veterans of the Vietnam Era (JANUARY 1988)
52.223-2 Clean Air and Water (Over $100,000) (APRIL 1984)
52.223-6 Drug Free Workplace (JANUARY 1997)
52.223-14 Toxic Chemical Release Reporting (OCTOBER 1996)
52.225-11 Restrictions on Certain Foreign Purchases
(OCTOBER 1996)
52.227-1 Authorization and Consent (Over $50,000) (JULY 1995)
52.227-2 Notice and Assistance Regarding Patent and Copyright
Infringement (Over $100,000) (AUGUST 1996)
52.227-3 Patent Indemnity (APRIL 1984)
52.227-14 Rights in Data - General (JUNE 1987)
<PAGE>
Contract No. N02-BC-81040
Page 22
52.232-9 Limitation on Withholding of Payments (APRIL 1984)
52.232-17 Interest (Over $100,000) (JUNE 1996)
52.232-20 Limitation of Cost (APRIL 1984)
52.232-23 Assignment of Claims (JANUARY 1986)
52.232-25 Prompt Payment (JUNE 1997)
52.232-33 Mandatory Information for Electronic Funds Transfer
Payment (AUGUST 1996)
52.233-1 Disputes (OCTOBER 1995)
52.233-3 Protest After Award (AUGUST 1996) With Alternate I
(JUNE 1985)
52.242-1 Notice of Intent to Disallow Costs (APRIL 1984)
52.242-3 Penalties for Unallowable Costs (Over $500,000)
(OCTOBER 1995)
52.242-4 Certification of Final Indirect Costs (JANUARY 1997)
52.242-13 Bankruptcy (Over $100,000) (JULY 1995)
52.243-2 Changes - Cost Reimbursement (AUGUST 1987) Alternate I
(APRIL 1984)
52.244-2 Subcontracts (Cost-Reimbursement and Letter
Contracts) (FEBRUARY 1997) *If written
consent to subcontract is required, the
identified subcontracts are listed in
ARTICLE B, Advance Understandings of the
contract.
52.244-5 Competition in Subcontracting (Over $100,000)
(DECEMBER 1996)
52.245-5 Government Property (Cost-Reimbursement, Time and
Material, or Labor-Hour Contract) (JANUARY 1986)
52.246-25 Limitation of Liability - Services (Over $100,000)
(FEBRUARY 1997)
52.249-6 Termination (Cost-Reimbursement) (SEPTEMBER 1996)
52.249-14 Excusable Delays (APRIL 1984)
52.253-1 Computer Generated Forms (JANUARY 1991)
b. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48
CFR CHAPTER 3) CLAUSES.
HHSAR
CLAUSE NO. TITLE AND DATE
---------- --------------
352.202-1 Definitions (APRIL 1984) Alternate I (APRIL 1984)
352.228-7 Insurance - Liability to Third Persons (DECEMBER 1991)
352.232-9 Withholding of Contract Payments (APRIL 1984)
<PAGE>
Contract No. N02-BC-81040
Page 23
352.233-70 Litigation and Claims (APRIL 1984)
352.242-71 Final Decisions on Audit Findings (APRIL 1984)
352.270-5 Key Personnel (APRIL 1984)
352.270-6 Publication and Publicity (JULY 1991)
352.270-7 Paperwork Reduction Act (APRIL 1984)
[End of GENERAL CLAUSES FOR A COST-REIMBURSEMENT SERVICE CONTRACT - Rev. 6/97]
<PAGE>
Contract No. N02-BC-81040
Page 24
ARTICLE I.2 AUTHORIZED SUBSTITUTION OF CLAUSES
ARTICLE I.1. of this SECTION is hereby modified as follows:
ALTERNATE I (JANUARY 1997) of FAR 52.215-26, INTEGRITY OF UNIT PRICES (JANUARY
1997) is added.
FAR 52.225-3, BUY AMERICAN ACT - SUPPLIES (JANUARY 1994) is deleted in its
entirety and FAR 52.225-7 BALANCE OF PAYMENTS PROGRAM (APRIL 1984) is
substituted therefor.
FAR 52.232-20, LIMITATION OF COST, is deleted in its entirety and FAR 52.232-22,
LIMITATION OF FUNDS (APRIL 1984) is substituted therefor.
FAR 52.232-33, MANDATORY INFORMATION FOR ELECTRONIC FUNDS TRANSFER PAYMENT
(AUGUST 1996) is deleted, and FAR 52.232-34, OPTIONAL INFORMATION FOR ELECTRONIC
FUNDS TRANSFER PAYMENT (AUGUST 1996) is substituted therefor.
ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES
- ----------------------------------------
This contract incorporates the following clauses by reference, with the same
force and effect, as if they were given in full text. Upon request, the
Contracting Officer will make their full text available.
a. FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES
1) FAR 52.215-31, Waiver of Facilities Capital Cost of Money (SEPTEMBER
1987).
2) FAR 52.217-9, Option to Extend the Term of the Contract (MARCH 1989).
"(a) The Government may extend the term of this contract by written
notice to the Contractor within 60 days prior to the
expiration date of this contract.
(c) The total duration of this contract, including the exercise of
any options under this clause, shall not exceed 60 months."
3) FAR 52.223-12, Refrigeration Equipment and Air Conditioners (MAY 1995).
4) FAR 52.242-15, Stop Work Order (AUGUST 1989) with ALTERNATE I
(APRIL 1984).
5) FAR 52.251-1, Government Supply Sources (APRIL 1984).
b. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION/PUBLIC
HEALTH SERVICE ACQUISITION REGULATION (HHSAR)/(PHSAR) (48 CHAPTER 3)
CLAUSES:
1) PHS 352.223-70, Safety and Health (Deviation) (AUGUST 1997).
2) PHS 352.280-2b, Care of Live Vertebrate Animals (OCTOBER 1986).
c. NATIONAL INSTITUTES OF HEALTH (NIH) RESEARCH CONTRACTING (RC) CLAUSES:
The following clauses are attached and made a part of this contract:
1) NIH (RC)-7, Procurement of Certain Equipment (APRIL 1984)
(OMB Bulletin 81-16).
<PAGE>
Contract No. N02-BC-81040
Page 25
ARTICLE I.4. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT
- ------------------------------------------------------------------
a. FAR 52.223-11, OZONE-DEPLETING SUBSTANCES (JUNE 1996)
(a) Definitions. Ozone-depleting substance, as used in this clause, means
any substance designated as Class I by the Environmental Protection
Agency (EPA) (40 CFR Part 82), including but not limited to
chlorofluorocarbons, halons, carbon tetrachloride, and methyl
chloroform; or any substance designated as class II by EPA (40 CFR
Part 82), including but not limited to hydrochlorofluorocarbons.
(b) The Contractor shall label products which contain or are manufactured
with ozone-depleting substances in the manner and to the extent
required by 42 U.S.C. 7671j (b), (c), and (d) and 40 CRF Part 82,
Subpart E as follows:
"WARNING: Contains (or manufactured with, if applicable) a
substance(s) which harm(s) public health and environment by
destroying ozone in the upper atmosphere."
*The Contractor shall insert the name of the substance(s).
b. FAR 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.
<PAGE>
Contract No. N02-BC-81040
Page 26
PART III
--------
SECTION J - LIST OF ATTACHMENTS
- -------------------------------
The following documents are attached and incorporated in this contract:
1. Invoice/Financing Request and Contract Financial Reporting Instructions
for NIH Cost-Reimbursement Type Contracts, NIH(RC)-4, (5/97), 5 pages.
2. Safety and Health, PHSAR Clause 352.223-70, (8/97), 1 pages.
3. Procurement of Certain Equipment, NIH(RC)-7, 4/l/84, 1 page.
4. Government Property - Schedule II-A, 8/4/97, 1 page.
5. Pathology Report, 1 page.
6. Animal Health Diagnostic Serology Submission Form, 1 page.
7. Animal Health Diagnostic Request Form, 1 page.
8. Introduction of Rodents and Rodent Products, NIH Manual 3043-1 dated
9/30/95, 10 pages.
9. Application for Permit to Introduce Rodent and Rodent Produce, NIH 2369-1
(Rev. 10/91), 1 page.
10. Permit to Introduce Rodents and Rodent Products, NIH 2369-2 (Rev. 10191),
1 page.
11. Material Transfer Agreement, 3 pages.
12. Animal Inventory and Breeding Record Sheet, 11/92, 1 page.
13. Animal Inventory Summary, 11/92, 1 page.
14. Animal Mortality Sheet, 11/92, 1 page.
PART IV
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SECTION K - REPRESENTATIONS AND CERTIFICATIONS
- ----------------------------------------------
The following documents are incorporated by reference in this contract:
1. Representations and Certifications, dated August 15, 1997.
2. Animal Welfare Assurance Number A3086-01.
END of the SCHEDULE
-------------------
(CONTRACT)
INVOICE/FINANCING REQUEST AND CONTRACT FINANCIAL REPORTING
----------------------------------------------------------
INSTRUCTIONS FOR NIH COST-REIMBURSEMENT CONTRACTS, NIH(RC)-4
------------------------------------------------------------
General: The contractor shall submit claims for reimbursement in the manner and
format described herein and as illustrated in the sample invoice/financing
request.
Format: Standard Form 1034, "Public Voucher for Purchases and Services Other
Than Personal", and Standard Form 1035, "Public Voucher for Purchases and
Services Other Than Personal- Continuation Sheet," or reproduced copies of such
forms marked ORIGINAL should be used to submit claims for reimbursement. In lieu
of SF-1034 and SF-1035, claims may be submitted on the payee's letter-head or
self-designed form provided that it contains the information shown on the sample
invoice/financing request.
Number of Copies: As indicated in the Invoice Submission Clause in the contract.
Frequency: Invoices/financing requests submitted in accordance with the Payment
Clause shall be submitted monthly unless otherwise authorized by the contracting
officer.
Cost Incurrence Period: Costs incurred must be within the contract performance
period or covered by precontract cost provisions.
Billing of Costs Incurred: If billed costs include: (1) costs of a prior billing
period, but not previously billed; or (2) costs incurred during the contract
period and claimed after the contract period has expired, the amount and
month(s) in which such costs were incurred shall be cited.
Contractor's Fiscal Year: Invoices/financing requests shall be prepared in such
a manner that costs claimed can be identified with the contractors fiscal year.
Currency: All NIH contracts are expressed in United States dollars. When
payments are made in a currency other than United States dollars, billings on
the contract shall be expressed, and payment by the United States Government
shall be made, in that other currency at amounts coincident with actual costs
incurred. Currency fluctuations may not be a basis of gain or loss to the
contractor. Notwithstanding the above, the total of all invoices paid under this
contract may not exceed the United States dollars authorized.
Costs Requiring Prior Approval: Costs requiring the contracting officer's
approval, which are not set forth in an Advance Understanding in the contract
shall be so identified and reference the Contracting Officer's Authorization
(COA) Number. In addition, any cost set forth in an Advance Understanding shall
be shown as a separate line item on the request.
Invoice/Financing Request Identification: Each invoice/financing request shall
be identified as either:
(a) Interim Invoice/Contract Financing Request - These are interim payment
requests submitted during the contract performance period.
(b) Completion Invoice - The completion invoice is submitted promptly upon
completion of the work; but no later than one year from the contract
completion date, or within 120 days after settlement of the final indirect
cost rates covering the year in which this contract is physically complete
(whichever date is later). The completion invoice should be submitted when
all costs have been assigned to the contract and all performance
provisions have been completed.
(c) Final Invoice - A final invoice may be required after the amounts owed
have been settled between the Government and the contractor (e.g.,
resolution of all suspensions and audit exceptions).
Preparation and Itemization of the Invoice/Financing Request: The contractor
shall furnish the information set forth in the explanatory notes below. These
notes are keyed to the entries on the sample invoice/financing request.
NIH(RC)-4 ATTACHMENT I
Rev. 5/97
<PAGE>
(a) Designated Billing Office Name and Address - Enter the designated billing
office and address, identified in the Invoice Submission Clause of the
contract, on all copies of the invoice/financing request.
(b) Invoice/Financing Request Number - Insert the appropriate serial number of
the invoice/financing request.
(c) Date Invoice/Financing Request Prepared - Insert the date the
invoice/financing request is prepared.
(d) Contract Number and Date - Insert the contract number and the effective
date of the contract.
(e) Payee's Name and Address - Show the contractors name (as it appears in the
contract), correct address, and the title and phone number of the
responsible official to whom payment is to be sent. When an approved
assignment has been made by the contractor, or a different payee has been
designated, then insert the name and address of the payee instead of the
contractor.
(f) Total Estimated Cost of Contract - Insert the total estimated cost of the
contract, exclusive of fixed-fee. For incrementally funded contracts,
enter the amount currently obligated and available for payment.
(g) Total Fixed-Fee - Insert the total fixed-fee (where applicable). For
incrementally funded contracts, enter the amount currently obligated and
available for payment.
(h) Billing Period - Insert the beginning and ending dates (month, day, and
year) of the period in which costs were incurred and for which
reimbursement is claimed.
(i) Incurred Cost - Current - Insert the amount billed for the major cost
elements, adjustments, and adjusted amounts for the current period.
(j) Incurred Cost - Cumulative - Insert the cumulative amounts billed for the
major cost elements and adjusted amounts claimed during this contract.
(k) Direct Costs - Insert the major cost elements. For each element, consider
the application of the paragraph entitled "Costs Requiring Prior Approval"
on page 1 of these instructions.
(1) Direct Labor - Include salaries and wages paid (or accrued) for
direct performance of the contract. For Key Personnel, list each
employee on a separate line. List other employees as one amount
unless otherwise required by the contract.
(2) Fringe Benefits - List any fringe benefits applicable -to direct
labor and billed as a direct cost. Fringe benefits included in
indirect costs should not be identified here.
(3) Accountable Personal Property - Include permanent research equipment
and general purpose equipment having a unit acquisition cost of
$1,000 or more and having an expected service life of more than two
years, and sensitive property regardless of cost (see the DHHS
Contractors Guide for Control of Government Property). Show permanent
research equipment separate from general purpose equipment. Prepare
and attach Form HHS-565, "Report of Accountable Property," in
accordance with the following instructions:
List each item for which reimbursement is requested. A reference
shall be made to the following (as applicable):
- The item number for the specific piece of equipment listed in
the Property Schedule.
- The Contracting Officer's Authorization letter and number, if
the equipment is not covered by the Property Schedule.
- Be preceded by an asterisk (*) if the equipment is below the
approval level.
NIH(RC)-4 ATTACHMENT I
Rev. 5/97
<PAGE>
(4) Materials and Supplies - Include equipment with unit costs of less
than $1,000 or an expected service life of two years or less, and
consumable material and supplies regardless of amount.
(5) Premium Pay - List remuneration in excess of the basic hourly rate.
(6) Consultant Fee - List fees paid to consultants. Identify consultant
by name or category as set forth in the contract's Advance
Understanding or in the COA letter, as well as the effort (i.e.,
number of hours, days, etc.) and rate being billed.
(7) Travel - Include domestic and foreign travel. Foreign travel is
travel outside of Canada, the United States and its territories and
possessions. However, for an organization located outside Canada, the
United States and its territories and possessions, foreign travel
means travel outside that country. Foreign travel must be billed
separately from domestic travel.
(8) Subcontract Costs - List subcontractor(s) by name and amount billed.
(9) Other - List all other direct costs in total unless exceeding $1,000
in amount. If over $1,000, list cost elements and dollar amounts
separately. If the contract contains restrictions on any cost
element, that cost element must be listed separately.
(l) Cost of Money (COM) - Cite the COM factor and base in effect during the
time the cost was incurred and for which reimbursement is claimed.
(m) Indirect Costs--Overhead - Identify the cost base, indirect cost rate, and
amount billed for each indirect cost category.
(n) Fixed-Fee Earned - Cite the formula or method of computation for the
fixed-fee (if any). The fixed-fee must be claimed as provided for by the
contract.
(o) Total Amounts Claimed - Insert the total amounts claimed for the current
and cumulative periods.
(p) Adjustments - Include amounts conceded by the contractor, outstanding
suspensions, and/or disapprovals subject to appeal.
(q) Grand Totals
The contracting officer may require the contractor to submit detailed support
for costs claimed on one or more interim invoices/financing requests.
FINANCIAL REPORTING INSTRUCTIONS:
These instructions are keyed to the Columns on the sample invoice/financing
request.
Column A--Expenditure Category - Enter the expenditure categories required by
the contract.
Column B--Cumulative Percentage of Effort/Hrs.-Negotiated - Enter the percentage
of effort or number of hours agreed to doing contract negotiations for each
employee or labor category listed in Column A.
Column C--Cumulative Percentage of Effort/Hrs.-Actual - Enter the percentage of
effort or number of hours worked by each employee or labor category listed in
Column A.
NIH(RC)-4 ATTACHMENT 1
Rev. 5/97
<PAGE>
Column D--Incurred Cost-Current - Enter the costs, which were incurred during
the current period.
Column E--incurred Cost-Cumulative - Enter the cumulative cost to date.
Column F-Cost at Completion - Enter data only when the contractor estimates that
a particular expenditure category will vary from the amount negotiated.
Realistic estimates are essential.
Column G- Contract Amount - Enter the costs agreed to during contract
negotiations for all expenditure categories listed in Column A.
Column H-Variance (Over or Under) - Show the difference between the estimated
costs at completion (Column F) and negotiated costs (Column G) when entries have
been made in Column F. This column need not be filled in when Column F is blank.
When a line item varies by plus or minus 10 percent, i.e., the percentage
arrived at by dividing Column F by Column G, an explanation of the variance
should be submitted. In the case of an overrun (net negative variance), this
submission shall not be deemed as notice under the Limitation of Cost Clause of
the contract.
Modifications: Any modification in the amount negotiated for an item since the
preceding report should be listed in the appropriate cost category.
Expenditures Not Negotiated: An expenditure for an item for which no amount was
negotiated (e.g., at the discretion of the contractor in performance of its
contract) should be listed in the appropriate cost category and all columns
filled in, except for G. Column H will of course show a 100 percent variance
along with those identified under H above.
NIH(RC)-4 ATTACHMENT 1
Rev. 5197
<PAGE>
<TABLE>
<S> <C>
SAMPLE INVOICE/FINANCING REQUEST AND CONTRACT FINANCIAL REPORT
====================================================================================================================================
(a) Billing Office Name and Address (b) Invoice/Financing Request No. ___________________________________
NATIONAL INSTITUTES OF HEALTH (c) Date Invoice Prepared ___________________________________________
National Cancer Institute, RCB
EPS, Room 620 (d) Contract No. ____________________________________________________
6120 EXECUTIVE BLVD MSC 7224
Bethesda, MD 20892-7224 Effective Date __________________________________________________
(e) Payee's Name and Address
ABC CORPORATION
100 Main Street (f) Total Estimated Cost ____________________________________________
Anywhere, USA zip code
(g) Total Fixed Fee _________________________________________________
Attn: Name, Title, & Phone Number of Official to Whom
Payment is Sent
====================================================================================================================================
(h) This invoice/financing request represents reimbursable costs for the period from __________ to _________
====================================================================================================================================
Cumulative Percentage of
Effort/Hrs. Incurred Cost
--------------------------------------------------------- Cost at Contract
Expenditure Category* Negotiated Actual (i) Current (j) Cumulative Completion Amount Variance
A B C D E F G H
- ------------------------------------------------------------------------------------------------------------------------------------
(k) Direct Costs:
- ------------------------------------------------------------------------------------------------------------------------------------
(1) Direct Labor $ 966,018
- ------------------------------------------------------------------------------------------------------------------------------------
(2) Fringe Benefts
(40.5% DL) 391,237
- ------------------------------------------------------------------------------------------------------------------------------------
(3) Sentinal Animals 2,767
- ------------------------------------------------------------------------------------------------------------------------------------
(4) Laundry/Clothing 42,690
- ------------------------------------------------------------------------------------------------------------------------------------
(5) Cleaning Supplies 11,020
- ------------------------------------------------------------------------------------------------------------------------------------
(6) Animal Housing 245,665
- ------------------------------------------------------------------------------------------------------------------------------------
(7) Lab & Tech Supplies 30,298
- ------------------------------------------------------------------------------------------------------------------------------------
(8) Media & Reagents 17,195
- ------------------------------------------------------------------------------------------------------------------------------------
(9) Overtime Premium 9,328
- ------------------------------------------------------------------------------------------------------------------------------------
(10) Transportation 16,064
- ------------------------------------------------------------------------------------------------------------------------------------
(11) Equip. Maintenance 32,000
- ------------------------------------------------------------------------------------------------------------------------------------
(12) Consultant Vet. 24,960
- ------------------------------------------------------------------------------------------------------------------------------------
(l) Total Direct Cost $1,398,005
- ------------------------------------------------------------------------------------------------------------------------------------
(m) Overhead (99% DL+FB) 1,343,682
- ------------------------------------------------------------------------------------------------------------------------------------
(n) Total Direct Cost + OH $2,741,687
- ------------------------------------------------------------------------------------------------------------------------------------
(o) G&A (21.3% TDC+OH) 667,312
- ------------------------------------------------------------------------------------------------------------------------------------
(p) Total Cost $3,800,236
- ------------------------------------------------------------------------------------------------------------------------------------
(q) Fixed Fee (7%) 266,016
- ------------------------------------------------------------------------------------------------------------------------------------
(r) Total Amount Claimed $4,066,252
- ------------------------------------------------------------------------------------------------------------------------------------
(s) Adjustments 0
- ------------------------------------------------------------------------------------------------------------------------------------
(t) Grand Total $4,066,252
- ------------------------------------------------------------------------------------------------------------------------------------
I certify that all payments are for appropriate purposes and in accordance with the contract.
_______________________________ ___________________________
(Name of Official) (Title)
* Attach details as specified in the contract
====================================================================================================================================
</TABLE>
<PAGE>
PHS 352.223-70 SAFETY AND HEALTH (DEVIATION) (AUGUST 1997)
- ----------------------------------------------------------
(a) To help ensure the protection of the life and health of all persons, and
to help prevent damage to property, the Contractor shall comply with all
Federal, State and local laws and regulations applicable to the work being
performed under this contract. These laws are implemented and/or enforced
by the Environmental Protection Agency, Occupational Safety and Health
Administration and other agencies at the Federal, State and local levels
(Federal, State and local regulatory/enforcement agencies).
(b) Further, the Contractor shall take or cause to be taken additional safety
measures as the Contracting Officer in conjunction with the project or
other appropriate officer, determines to be reasonably necessary. If
compliance with these additional safety measures results in an increase or
decrease in the cost or time required for performance of any part of work
under this contract, an equitable adjustment will be made in accordance
with the applicable "Changes" Clause set forth in this contract.
(c) The Contractor shall maintain an accurate record of, and promptly report
to the Contracting Officer, all accidents or incidents resulting in the
exposure of persons to toxic substances, hazardous materials or hazardous
operations; the injury or death of any person; and/or damage to property
incidental to work performed under the contract and all violations for
which the Contractor has been cited by any Federal, State or local
regulatory/enforcement agency. The report shall include a copy of the
notice of violation and the findings of any inquiry or inspection, and an
analysis addressing the impact these violations may have on the work
remaining to be performed. The report shall also state the required
action(s), if any, to be taken to correct any violation(s) noted by the
Federal, State or local regulatory/enforcement agency and the time frame
allowed by the agency to accomplish the necessary corrective action.
(d) If the Contractor fails or refuses to comply promptly with the Federal,
State or local Regulatory/enforcement agency's directive(s) regarding any
violation(s) and prescribed corrective action(s), the Contracting Officer
may issue an order stopping all or part of the work until satisfactory
corrective action (as approved by the Federal, State or local
regulatory/enforcement agencies) has been taken and documented to the
Contracting Officer. No part of the time lost due to any stop work order
shall be subject to a claim for extension of time or costs or damages by
the Contractor.
(e) The Contractor shall insert the substance of this clause in each
subcontract involving toxic substances, hazardous materials, or
operations. Compliance with the provisions of this clause by
subcontractors will be the responsibility of the Contractor.
(End of clause)
Safety and Health Clause (Deviation) ATTACHMENT 2
PHS 352.223-70, (8/97)
<PAGE>
PROCUREMENT OF CERTAIN EQUIPMENT
--------------------------------
Notwithstanding any other clause in this contract, the Contractor will not be
reimbursed for the purchase, lease, or rental of any item of equipment listed in
the following Federal Supply Groups, regardless of the dollar value, without the
prior written approval of the Contracting Officer.
67 - Photographic Equipment
69 - Training Aids and Devices
70 - General Purpose ADP Equipment, Software, Supplies and Support
(Excluding 7045-ADP Supplies and Support Equipment.)
71 - Furniture
72 - Household and Commercial Furnishings and Appliances
74 - Office Machines and Visible Record Equipment
77 - Musical Instruments, Phonographs, and Home-type Radios
78 - Recreational and Athletic Equipment
When equipment in these Federal Supply Groups is requested by the Contractor and
determined essential by the Contracting Officer, the Government will endeavor to
fulfill the requirement with equipment available from its excess personal
property sources, provided the request is made under a cost-reimbursement
contract. Extensions or renewals of approved existing leases or rentals for
equipment in these Federal Supply Groups are excluded from the provisions of
this article.
NIH(RC)-7 (4/1/84) ATTACHMENT 3
OMB Bulletin 81-16
<PAGE>
GOVERMENT PROPERTY - SCHEDULE
-----------------------------
<TABLE>
<S> <C>
- -----------------------------------------------------------------------------------------------------------------------------------
Date: August 4, 1997 BIOQUAL, INC. Report No. 4
Person Responsible for Report: Nancy A. Madden 9600 Medical Center Drive Page No. 1 of 2
Telephone No.: (301) 251-0633 Rockville, Maryland 20850-3336 ANNUAL REPORT
- -----------------------------------------------------------------------------------------------------------------------------------
ITEM GFP MODEL OR MRF. SERIAL UNIT ACQ. GOVT. ACQ. DATE REC'D
NO. DESCRIPTION & NSN OR CAP MANUFACTURER TYPE NUMBER COST ID NUMBER AUTHORITY MO/YR.
- -----------------------------------------------------------------------------------------------------------------------------------
1 Freezer, Liquid Nitrogen GFP Union Carbide LR-310 290-004-M4 $5,592.00 01029807 II-A 01/83
- -----------------------------------------------------------------------------------------------------------------------------------
2 Liquid Nitro. Inven. Sys. GFP Union Carbide LR-310112CT S 899-0314 $1,225.00 01029808 II-A 01/83
- -----------------------------------------------------------------------------------------------------------------------------------
3 Liquid Nitro. Inven. Sys. GFP Revco Unknown 77656 $ 620.00 01029810 II-A 01/83
- -----------------------------------------------------------------------------------------------------------------------------------
4 Freezer, Upright (-20(degrees)C) GFP Kenmore 1067392-050 S 904388-72 $ 567.00 01029811 II-A 01/83
- -----------------------------------------------------------------------------------------------------------------------------------
5 Freezer, Upright (-20(degrees)C) GFP Sears 8312050-47T E14130539 $ 577.00 01029812 II-A 01/83
- -----------------------------------------------------------------------------------------------------------------------------------
6 Microscope GFP Bausch & Lomb Unknown Unknown $ 700.00 01029813 II-A 01/83
- -----------------------------------------------------------------------------------------------------------------------------------
7 Freezer, Lab (-20(degrees)C) GFP Rheem LF2330A-N-A YT17322E $3,103.05 01029815 II-A 11/84
- -----------------------------------------------------------------------------------------------------------------------------------
8 Mobile Rabbit Cage Rack GFP Suburban Surgical SS Unknown $1,684.72 01029817 II-A 12/85
with Six Rabbit Cages
- -----------------------------------------------------------------------------------------------------------------------------------
9 Mobile Rabbit Cage Rack GFP Suburban Surgical SS Unknown $1,684.72 01029818 II-A 12/85
with Six Rabbit Cages
- -----------------------------------------------------------------------------------------------------------------------------------
10 Mobile Rabbit Cage Rack GFP Suburban Surgical SS Unknown $2,021.08 01029819 II-A 12/86
with Six Rabbit Cages
- -----------------------------------------------------------------------------------------------------------------------------------
11 Mobile Rabbit Cage Rack GFP Suburban Surgical SS Unknown $2,021.08 01029820 II-A 12/86
with Six Rabbit Cages
- -----------------------------------------------------------------------------------------------------------------------------------
12 Mobile Rabbit Cage Rack GFP Suburban Surgical SS Unknown $2,021.08 01029821 II-A 12/86
with Six Rabbit Cages
- -----------------------------------------------------------------------------------------------------------------------------------
13 Mobile Rabbit Cage Rack GFP Suburban Surgical SS Unknown $2,021.08 01029822 II-A 12/86
with Six Rabbit Cages
- -----------------------------------------------------------------------------------------------------------------------------------
14 Mobile Rabbit Cage Rack GFP Suburban Surgical SS Unknown $2,021.08 01029823 II-A 12/86
with Six Rabbit Cages
- -----------------------------------------------------------------------------------------------------------------------------------
15 Mobile Rabbit Cage Rack GFP Suburban Surgical SS Unknown $2,021.08 01029824 II-A 12/86
with Six Rabbit Cages
- -----------------------------------------------------------------------------------------------------------------------------------
16 Top Loading Balance GFP Baxter Scientific Z400DR 10144PU $1,001.00 01029825 II-A 04/88
- -----------------------------------------------------------------------------------------------------------------------------------
</TABLE>
Government Property Schedule II-A ATTACHMENT 4
(8/4/97)
<PAGE>
GOVERMENT PROPERTY - SCHEDULE
-----------------------------
<TABLE>
<S> <C>
- -----------------------------------------------------------------------------------------------------------------------------------
Date: August 4, 1997 BIOQUAL, INC. Report No. 4
Person Responsible for Report: Nancy A. Madden 9600 Medical Center Drive Page No. 2 of 2
Telephone No.: (301) 251-0633 Rockville, Maryland 20850-3336 ANNUAL REPORT
- -----------------------------------------------------------------------------------------------------------------------------------
ITEM GFP MODEL OR MRF. SERIAL UNIT ACQ. GOVT. ACQ. DATE REC'D
NO. DESCRIPTION & NSN OR CAP MANUFACTURER TYPE NUMBER COST ID NUMBER AUTHORITY MO/YR.
- -----------------------------------------------------------------------------------------------------------------------------------
17 Precision Water Bath GFP Baxter Scientific 66551 27AW-4 $ 508.25 01029826 II-A 04/88
- -----------------------------------------------------------------------------------------------------------------------------------
18 Refrig/Freezer (-20(degrees)C) GFP Sears Coldspot 106.6678201 S7B344149 $ 311.00 01029827 II-A 08/88
- -----------------------------------------------------------------------------------------------------------------------------------
19 Illuminator Microscope GFP AO 1130A 252675 $1,200.00 00811059 II-A 08/88
- -----------------------------------------------------------------------------------------------------------------------------------
20 Hood, Biohazard/Safety Cabinet GFP Gelaire BSA4A/B3 10807 $3,881.20 00811060 II-A 09/88
- -----------------------------------------------------------------------------------------------------------------------------------
21 Hood, StayClean Workbench GFP Lab Products 30909 SHOW87 $6,663.50 00811061 II-A 09/88
- -----------------------------------------------------------------------------------------------------------------------------------
22 Central Proportioner GFP Edstrom CP653 1016 $4,810.00 00811058 II-A 06/90
- -----------------------------------------------------------------------------------------------------------------------------------
23 Freezer, (-70(degrees)C) GFP Revco ULT 390-5-A-U-A PZ11383A $3,206.00 01029809 II-A 06/90
- -----------------------------------------------------------------------------------------------------------------------------------
24 Centrifuge GFP Damon IEC PR-J 10810 $3,000.00 01029795 II-A 10/90
- -----------------------------------------------------------------------------------------------------------------------------------
25 Freezer, (-20(degrees)C) GFP Sears Coldspot 762940 61459747 $4,194.00 00922710 II-A 07/91
- -----------------------------------------------------------------------------------------------------------------------------------
26 Freezer, (-20(degrees)C) GFP Sears Kenmore 16.253.8193611 S907202066 $ 349.00 00811995 II-A 08/91
- -----------------------------------------------------------------------------------------------------------------------------------
27 Freezer, (-20(degrees)C) GFP Sears Coldspot 106 5A198515 $ 500.00 00916622 II-A 08/91
- -----------------------------------------------------------------------------------------------------------------------------------
28 Printer GFP IBM Proprinter 472613590 $1,806.00 00916623 II-A 08/91
- -----------------------------------------------------------------------------------------------------------------------------------
29 Hood, StayClean Workbench GFP Lab Products 30909B 693740-9218 $7,549.60 00898219 II-A 08/92
- -----------------------------------------------------------------------------------------------------------------------------------
30 Autoclave GFP AMSCO M74VS 0116379-001 $2,760.00 00804692 II-A 08/92
- -----------------------------------------------------------------------------------------------------------------------------------
31 Bottle Washer GFP Girton 664 75091702 $ 500.00 00804693 II-A 08/92
- -----------------------------------------------------------------------------------------------------------------------------------
32 Biological Hood GFP CCI Unknown S 21103 Surplus 00851389 Transfer 06/94
- -----------------------------------------------------------------------------------------------------------------------------------
33 Freezer (-70(degrees)C) CAP Revco ULT 10905A12 SO1E205161SE $5,100.00 01188419 COA#1 05/95
- -----------------------------------------------------------------------------------------------------------------------------------
34 Freezer (-20(degrees)C) CAP Westinghouse MFU21M3BW3 WB54704399 $ 503.99 01250161 COA#2 12/95
- -----------------------------------------------------------------------------------------------------------------------------------
35 Freezer (-20(degrees)C) CAP Westinghouse MFU21M3BW3 WB54704399 $ 503.99 01250162 COA#2 12/95
- -----------------------------------------------------------------------------------------------------------------------------------
</TABLE>
Government Property Schedule II-A ATTACHMENT 4
(8/4/97)
<PAGE>
<TABLE>
<S><C>
INVESTIGATOR ______________ NCI-FREDERICK CANCER RESEARCH FACILITY HISTO.# _______________
PROJECT ___________________ PATHOLOGY/HISTOTECHNOLOGY LABORATORY AHDL# _________________
PO/H# _____________________ LOG BOOK# _____________
BLDG./TELE. _______________ DATE __________________
PATHOLOGY REPORT
- -------------------------------------------------------------------------------------------------------
Animal Species ____________ Strain ____________ Age ______ Sex ______ Weight _________
I.D. ____________________ Supplier ___________________ Housing Bldg. ___________ Room ______
- -------------------------------------------------------------------------------------------------------
Supporting Studies: (circle) Serology, Parasitology, Microbiology _______________ Other _________
- -------------------------------------------------------------------------------------------------------
Mode of Death: Natural ___________________ Euthanasia Method __________________
Fixative Used __________________
- -------------------------------------------------------------------------------------------------------
Organs Submitted: (circle) Organs Examined Microscopically (check)
Lungs, Heart, Liver, Spleen, Kidneys, Adrenals, Pancreas, Stomach, S. Intestine, Colon, Gut Roll,
Lymph Nodes, Bladder, Skin Muscle, Head, Brain, Eyes, Thyroid, Parathyroid, Salivary Glands, Pituitary,
Thymus, Bone, Uterus, Gonads, Prostate, Tumor, Other __________________
- -------------------------------------------------------------------------------------------------------
Animal History and Clinical Summary (Include information as to injections, experimental manipulations
and biohazards):
- -------------------------------------------------------------------------------------------------------
Gross Necropsy Observations, Comments and Requests:
=======================================================================================================
DO NOT WRITE BELOW THIS LINE
- -------------------------------------------------------------------------------------------------------
Rec'd _________________ Comments:
Trimmed _______________
Embedded ______________
Cut ___________________ # of slides___________ ck-out _________
- -------------------------------------------------------------------------------------------------------
Microscopic Observations, Diagnosis and Comments:
- -------------------------------------------------------------------------------------------------------
PATHOLOGIST: DATE:
- -------------------------------------------------------------------------------------------------------
096-90
Pathology Report
</TABLE>
<PAGE>
<TABLE>
<S> <C>
- ------------------------------------------------------------------------------------------------------------------------------------
ANIMAL HEALTH DIAGNOSTIC SEROLOGY SUBMISSION FORM Reviewed by______________________
Name________________________________,
Quarantine #________________________, AHDL #________________
Request Date_______, APO #_______, Project # _______, Page _____ of ______
Building__________, Room______, I.D. #____________, Species/Strain____________________________ , Age_______, Sex_______
- ------------------------------------------------------------------------------------------------------------------------------------
Circle Test Requested HAI ELISA IFA Lab Use Only
One --------------------------------------------------------------------------------------------------------
# of Samples
P R K
o S S C R
l E e E e G M V V
______________ y c n c n R D y L / / E L
K H S M o t d M t d P e M V c C S H D C D
Diluted ______________ R - V V m r a H r a V o V I o M D - I M H
V 1 5 M a o i V o i M 3 M I p V A 1 M V V
1:5 Y N ______________ --------------------------------------------------------------------------------------------------------
- ------------------------------------------------------------------------------------------------------------------------------------
Room # ACC # Inves ID 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1
0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Comments
0 1 0 0 0 0 1 4 5 4 4 4 5 5 4 5 2 5 5 5 5 5 1
4 5 2 3 5 7 8 3 2 7 8 9 0 1 5 4 4 3 7 8 5 5 9
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20/
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21/ Completed:
- -------------------------------------------------------------------------------------------------------------------------
22/ _________
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23/
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24/
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25/
- ------------------------------------------------------------------------------------------------------------------------------------
- - or Blank Space = Negative AC = Anticomplementary serum AE - Serum Autoagglutinates NT - No test
IS - Insufficient serum NS = Sample not submitted for test TC - Reacts with tissue culture NSR - Non-specific reaction
- ------------------------------------------------------------------------------------------------------------------------------------
Animal Health Diagnostic Serology Submission Form ATTACHMENT 6
</TABLE>
<PAGE>
<TABLE>
<S><C>
- -------------------------------------------------------------------------------------------------------------------------------
ANIMAL HEALTH DIAGNOSTIC REQUEST FORM
Name ______________________, Reviewed by ____________
Quarantine # ______________, AHDL # ____________
Request Date ______, APO/H # ___________, Project # __________, Page __ of __
Building _______________, Room _________, I.D. # ________, Species/Strain ______________________, Age ______, Sex _____
- -------------------------------------------------------------------------------------------------------------------------------
Circle first and Sample Type D. Hair 90 Hair 33 D. Cecum 85 Anal Tape 32 Feces 30 Intest. Content 37
and last ACC #
Maximum # Samples ---------- ------- ----------- ------------ -------- ------------------
of 11 per
page. Test Requested Ecto 9550 Ecto 9550 Endo 9350 Endo 9350 Endo 9350 Endo 9350
===============================================================================================================================
Room # Inves ID
- -------------------------------------------------------------------------------------------------------------------------------
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Cecum 74 N/P Wash 51 HP/05
- -------------------------------------------------------------------------------------------------------------------------------
- -------------------------------------------------------------------------------------------------------------------------------
Bact 9050 Bact 9050 99
- -------------------------------------------------------------------------------------------------------------------------------
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Animal Health Diagnostic Request Form ATTACHMENT 7
</TABLE>
<PAGE>
NIH MANUAL 3043-1
DATE: 09/30/95
REPLACES: 11/22/91
ISSUING OFFICE: NCRR/VRP 402-2799
INTRODUCTION OF RODENTS AND RODENT PRODUCTS
Table of Contents
A. Purpose
B. Background
C. Applicability
D. Definitions
E. Responsibilities
F. Policy
G. Procedure for Introduction of Rodents
H. Procedure for Introduction of Rodent Products
I. Quarantine Permit Service Office (QPSO)
J. Additional Information
APPENDICES
1. Introduction of Rodents or Rodent Products from Non-Approved Sources
2. Form NIH 2369- 1, "Application for Permit to Introduce Rodents and Rodent
Products"
NIH Manual 3043-1 (9/30/95) ATTACHMENT 8
<PAGE>
NIH MANUAL 3043-1 PAGE 1
DATE: 09/30/95
REPLACES: 11/22/91
ISSUING OFFICE: NCRR/VRP 402-2799
INTRODUCTION OF RODENTS AND RODENT PRODUCTS
A. Purpose. This Policy Manual establishes procedures designed to prevent the
introduction of infected rodents and rodent products into the National
Institutes of Health which could: (1) adversely affect the health of
rodents used in research; (2) directly or indirectly interfere with
research; or (3) pose a health hazard to personnel.
B. Background. The conduct of a vigorous research program necessitates the
movement of animals and their tissues from animal colony to animal colony
and between laboratories. This creates the possibility of introducing
agents that are pathogenic to either animals or humans. Examples of the
latter include the lymphocytic choriomeningitis (LCM) virus and the
hantaviruses, which can have serious implications for human health.
Hantaviruses infect wild rodents and have been detected in laboratory rats
in Europe and Asia; humans in contact with infected animals can become ill
and occasionally die.
Federal regulations pertaining to the movement of laboratory rodents or
their products relate mainly to organisms causing diseases in humans or
domestic poultry or livestock. Thus, it is important for the NIH to
supplement these regulations with policies that address concerns relating
to protection of its intramural animal colonies and scientific and support
staff in contact with animals or animal products.
C. Applicability. The policies and procedures in this chapter apply when
introducing into any National Institutes of Health (NIH) facility rodents
and rodent products that originate from sources other than those approved
by the Veterinary Resources Program (VRP), National Center for Research
Resources (NCRR). This policy also applies to facilities of other Agencies
on NIH property.
D. Definitions.
1. Animal Program Director (APD). The individual (usually a
veterinarian) who receives delegated program authority from the
Director or Scientific Director for all activities involving animals
in the ICD.
2. Approved Source. A source of rodents or rodent products which has a
contract established with, and maintained by, the NCRR. VRP or a
comparable contract with other programs within the NIH to supply
genetically-defined, specific pathogen-free
NIH Manual 3043-1 (9/30/95) ATTACHMENT 8
<PAGE>
NIH MANUAL 3043-1 PAGE 2
DATE: 09/30/95
REPLACES: 11/22/91
ISSUING OFFICE: NCRR/VRP 402-2799
INTRODUCTION OF RODENTS AND RODENT PRODUCTS
animals to NIH investigators. These contracts characteristically
require barrier production practices, genetic management and
monitoring, microbiologic standards and health surveillance, and
regular site visits to ensure the availability of high-quality
animals suitable for NIH research Proposals for additions to the list
of approved sources are evaluated by the VRP.
3. Blanket Purchase Agreement (BPA). Contract agreement with a vendor to
facilitate anticipated repetitive purchases for supplies and
services.
4. Domestic Source. A source of rodents or rodent products located
within the United States.
5. Facility Veterinarian. The veterinarian who has direct or delegated
responsibility for the management of the animal facility.
6. NIH Facility. Any building, trailer, research laboratory or other
facility or part of a facility, whether or not animals are housed or
used there, associated with the NIH intramural research program. This
includes any facility on the Bethesda, Maryland, campus, the NIH
Animal Center near Poolesville, Maryland, off-campus leased
facilities and other sites where intramural research is performed.
7. Nondomestic Source. A source of rodents or rodent products not
located within the United States.
8. Nonapproved Source. A source of rodents or rodent products that does
not meet the definition of an approved source.
9. Rodent. Any species of small gnawing mammals, including but not
limited to mice, rats, guinea pigs, and hamsters.
10. Rodent Import Officer. The individual appointed by the Director of
the VRP, NCRR, to have delegated responsibility for activities
defined in this policy.
11. Rodent Products. Any rodent tissue or derivative, such as antibodies
(polyclonal or monoclonal), body fluids, proteins, or cells unless
contained in commercially available test kits when these reagents
have been produced or processed in a manner that will exclude or
inactivate all pathogenic agents.
NIH Manual 3043-1 (9/30/95) ATTACHMENT 8
<PAGE>
NIH MANUAL 3043-1 PAGE 3
DATE: 09/30/95
REPLACES: 11/22/91
ISSUING OFFICE: NCRR/VRP 402-2799
INTRODUCTION OF RODENTS AND RODENT PRODUCTS
12. Quarantine Permit Service Office (QPSO). An office in the
Occupational Safety and Health Branch of the Division of Safety which
assists investigators obtain permits often required when
importing/exporting animals, animal products, etiologic agents, or
vectors of human or animal disease (Building 13/3KO4, 496-3353).
E. Responsibilities.
1. Animal Program Director (APD). (a) Assists the principal
investigator/applicant in securing approvals, permits,
transportation, etc., related to the introduction of rodents or
rodent products to an animal facility or laboratory; (b) reviews and
approves or disapproves applications for introduction of rodents from
nonapproved domestic sources into laboratories of the ICD; and (c)
reviews, provides concurrences, and forwards to the facility
veterinarian applications for introduction of rodents or rodent
products from nonapproved sources into animal facilities. These
responsibilities may be delegated to the facility or subordinate
veterinarians under the APD's supervision.
2. Director, VRP, NCRR. Implements those aspects of this policy relating
to the VRP and the Rodent Import Officer.
3. Facility Veterinarian. Reviews, provides concurrence and forwards to
VRP applications for the introduction of rodents or rodent products
from nonapproved sources into animal facilities which are under
his/her authority and responsibility, including central or shared
facilities.
4. ICD Scientific Director. Ensures compliance with this policy by
intramural staff within his/her Institute, Center, or Division (ICD).
5. Laboratory/Branch Chief Reviews and approves or disapproves the
introduction of rodent products into the laboratory by a principal
investigator under his or her supervision after assessing the
zoonotic potential of the material and determining if testing is
required prior to importation and use.
NIH Manual 3043-1 (9/30/95) ATTACHMENT 8
<PAGE>
NIH MANUAL 3043-1 PAGE 4
DATE: 09/30/95
REPLACES: 11/22/91
ISSUING OFFICE: NCRR/VRP 402-2799
INTRODUCTION OF RODENTS AND RODENT PRODUCTS
6. NIH/NCRR/VRP Rodent Import Officer. (a) Reviews and approves or
disapproves applications for introduction of rodents or rodent
products from nonapproved sources into NIH animal facilities; (b)
designates the quarantine location and release criteria for animals
being introduced into NIH animal facilities; and (c) coordinates the
use of the VRP Rodent and Rabbit Quarantine Unit at the NIH Animal
Center near Poolesville, Maryland.
7. Ordering Official. Assures that receipt of all orders, including b@et
purchase agreements (BPAs), are entered into DELPRO. The ICD ordering
official will not place an order (BPAS) for rodent products into
DELPRO unless a copy of the Permit to Introduce Rodents and Rodent
Products is received from the ICD APD.
8. Principal Investigator/Applicant. (a) Submits applications and/or
secures approvals prior to the ordering and introduction of rodents
or rodent products, including rodent products purchased on blanket
purchase agreements, into NIH laboratories or animal facilities; (b)
secures any additional permits which may be required, such as USDA
permits, when necessary (refer to Section I); and (c) arranges
through the ICD veterinary staff transportation which is in
compliance with federal and state regulations and NIH policy.
F. Policy. Rodents or rodent products from a nonapproved source shall not be
introduced into NIH animal facilities without prior written approval of
the ICD Scientific Director or a delegate thereof (i.e., the APD) and/or
the VRP Director, NCRR, or delegate thereof (i.e., the Rodent Import
Officer). Similarly, no living or nonliving material derived from rodents
from a nonapproved source will be introduced into NIH laboratories without
specific approval of the Laboratory/Branch Chief or the APD. Rodents or
rodent products known to be infected with LCM, ectromelia virus, a
hantavirus, or other major zoonotic rodent agents are excluded from NTH
facilities. Under special circumstances, the Deputy Director for
Intramural Research (DDIR) can approve exceptions to this restriction.
G. Procedure for Introduction of Rodents. (See Appendix I for schematic of
procedures.) The introduction of rodents from nonapproved sources requires
submission and approval of NIH Form 2369-1, Application for Permit to
Introduce Rodents and Rodent Products(see Appendix 2). In situations where
quarantine is likely to be required, applications should be submitted at
least 60 days prior to the anticipated date of entry into an NIH animal
facility to allow time for diagnostic testing. Procedures for submission
and approval are as follows:
NIH Manual 3043-1 (9/30/95) ATTACHMENT 8
<PAGE>
NIH MANUAL 3043-1 PAGE 5
DATE: 09/30/95
REPLACES: 11/22/91
ISSUING OFFICE: NCRR/VRP 402-2799
INTRODUCTION OF RODENTS AND RODENT PRODUCTS
1. Animals from nondomestic sources:
j. The principal investigator must complete and submit the
application to his/her APD. The APD will obtain the
concurrence of the facility veterinarian and then forward it
to the Rodent Import Officer. In most cases, importation from
nondomestic sources will require quarantine and health
assessment at the VRP Rodent and Rabbit Quarantine Unit
located at the NIH Animal Center near Poolesville, Maryland.
If animals are being brought to NIH for tissue harvesting
only, quarantine may be minimal, but tissues must be harvested
at the Poolesville Quarantine Facility.
k. If the animals are destined for an NIH animal facility, the
APD will obtain additional health status information to be
attached to the application. The facility veterinarian must
specify on the application the animal health requirements to
be met, in addition to negative test results for LCM and
ectromelia viruses, prior to release from quarantine.
c. Animals will be quarantined at the VRP Rodent and Rabbit
Quarantine Unit located at the NIH Animal Center near
Poolesville, Maryland or an alternative site approved by the
Rodent Import Officer. The Rodent Import Officer will maintain
a list of recognized rodent agents developed with the Animal
Program Directors and approved by the Animal Research Advisory
and Safety Committee which must be excluded from NIH animal
facilities. The Rodent Import Officer, in consultation with
the facility veterinarian, will: (1) specify the criteria for
release from quarantine; (2) conduct tests and review results;
and (3) release animals as appropriate. Copies of all results
from tests performed during quarantine will be provided to the
facility veterinarian by the Rodent Import Officer.
2. Animals from nonapproved domestic sources.
a. The principal investigator must complete and submit the
application to his/her APD.
NIH Manual 3043-1 (9/30/95) ATTACHMENT 8
<PAGE>
NIH MANUAL 3043-1 PAGE 6
DATE: 09/30/95
REPLACES: 11/22/91
ISSUING OFFICE: NCRR/VRP 402-2799
INTRODUCTION OF RODENTS AND RODENT PRODUCTS
b. 1) If animals are destined for a laboratory for holding
less than 12 hours, where no contact with other animals
is planned and no materials from the animals will be
inoculated into rodents or used in materials destined
for introduction into rodents, then the application can
be approved by the APD. A permit number will be obtained
from the Rodent Import Officer and the APD will provide
the Rodent Import Officer with a copy of the application
and the permit.
2) If animals are destined for a laboratory for holding
more than 12 hours, where no contact with other animals
is planned and no material from those animals will be
introduced into rodents or used in materials destined
for introduction into rodents, the ICD Animal Care and
Use Committee (ACUC) must approve the holding of the
animals in the laboratory. The application can then be
evaluated by the APD and approved if appropriate.
3) If animals are destined for an animal facility or will
come into contact with other rodents, or if materials
derived from the imported rodents will be inoculated
into rodents or used in materials destined for
introduction into rodents, the APD will obtain
additional health status information and attach it to
the application. Concurrence of the facility
veterinarian must also be obtained. Prior to forwarding
the application to the Rodent Import Officer, the
facility veterinarian must specify on the application
the animal health requirements necessary for entry into
the designated animal facility, including the mandatory
negative test results for LCM and ectromelia viruses.
C. The Rodent Import Officer, in consultation with the facility
veterinarian and principal investigator, will: (1) designate
the quarantine location; and (2) specify the criteria for
release from quarantine. If the VRP Rodent and Rabbit
Quarantine Unit, located at the NIH Animal Center is used, the
Rodent Import Officer will: (1) conduct testing and review
results; (2) provide results to the facility veterinarian; and
(3) release animals as appropriate. Non-VRP quarantine
locations must provide the NIH Rodent Import Officer with
documentation that release criteria have been met prior to
release of the animals.
NIH Manual 3043-1 (9/30/95) ATTACHMENT 8
<PAGE>
NIH MANUAL 3043-1 PAGE 7
DATE: 09/30/95
REPLACES: 11/22/91
ISSUING OFFICE: NCRR/VRP 402-2799
INTRODUCTION OF RODENTS AND RODENT PRODUCTS
H. Procedure for Introduction of Rodent Products. (See Appendix 1 for
schematic of procedures.) The introduction of rodent products into NIH
laboratories or animal facilities also requires the submission and
approval of an application, NIH Form 2369- 1, or receipt of permission
from the principal investigator's laboratory or branch chief, as described
below:
1. Procedure for Introduction of Rodent Products into an NIH Animal
Facility.
The principal investigator must complete and submit the application
through the APD, or his/her designee, to the facility veterinarian.
This includes the purchase of rodent products on BPAS. Unless a
recent Mouse Antibody Production (MAP)/Rat Antibody Production
(RAP)/Hamster Antibody Production (HAP) test result is available,
cells must be maintained frozen until tested and determined to be
free of LCM and ectromelia viruses, at a minimum, before introduction
into an NIH animal facility. The facility veterinarian will issue a
permit listing the agents that the product must be free of, including
the agents listed above. The permit number will be obtained from the
Rodent Import Officer. The facility veterinarian will provide a copy
of the application and permit to the Rodent Import Officer.
Alternatively, a permit may be issued if the product will be
inoculated into animals within an appropriate quarantine facility
such as the VRP Rodent and Rabbit Quarantine Unit at the NIH Animal
Center near Poolesville, Maryland.
The principal investigator will not introduce the animal product into
an NIH animal facility unless the facility veterinarian receives the
test results and approves the introduction.
2. Procedure for Introduction of Rodent Products into an NIH Laboratory.
If rodent products will not be introduced into, or come in contact
with live animals, a permit is not required. The Quarantine Permit
Service Office (QPSO), Occupational Safety and Health Branch,
Division of Safety, should be consulted to determine if a USDA permit
is required (for reasons stated below). It is the responsibility of
the principal investigator's laboratory or branch chief to assess the
zoonotic potential of the material and determine if testing is
required prior to importation and use. Assistance in making this
determination is available from the NIH Biosafety Officer,
Occupational Safety and Health Branch Division of Safety (496-2960).
NIH Manual 3043-1 (9/30/95) ATTACHMENT 8
<PAGE>
NIH MANUAL 3043-1 PAGE 8
DATE: 09/30/95
REPLACES: 11/22/91
ISSUING OFFICE: NCRR/VRP 402-2799
INTRODUCTION OF RODENTS AND RODENT PRODUCTS
3. Alternative Methods for Introduction of Non-living Rodent Products.
As an alternative to conducting MAP/RAP/HAP testing of nonliving
rodent products coming to the NIH from an unapproved or nondomestic
source, the laboratory or branch chief and/or the APD or his/her
designee, may approve the sterilization of the products. It is the
responsibility of the individuals designated above to ensure that the
method of sterilization is appropriate and adequate/effective prior
to introduction of the material into NIH facilities. In the case of
materials being introduced into laboratories, the Laboratory Chief is
the approving official; in the case of an animal facility, the
facility veterinarian is the approving official.
I. Quarantine Permit Service Office (QPSO), Occupational Safety and Health
Branch, Division of Safety.
Several agencies of the United States Government regulate and require
permits for the importation, shipment, or exportation of animals, animal
products, or etiologic agents or vectors of human or animal diseases. The
Quarantine Permit Service Office (QPSO) of the NIH Occupational Safety and
Health Branch, Division of Safety, will provide investigators with
assistance and appropriate application forms necessary to import, export,
or transport regulated materials or animals.
1. The United States Department of Agriculture (USDA) Animal and Plant
Health Inspection Service (APHIS) has statutory authority to regulate
the importation of any animal-derived material or biological material
that has been in contact with material of animal origin. Thus, USDA
permits are required for the importation of monoclonal antibodies,
hybridoma cell lines, cell cultures, and other biologic materials
that have been in contact with material of animal origin, such as
fetal bovine serum.
NIH Manual 3043-1 (9/30/95) ATTACHMENT 8
<PAGE>
NIH MANUAL 3043-1 PAGE 9
DATE: 09/30/95
REPLACES: 11/22/91
ISSUING OFFICE: NCRR/VRP 402-2799
INTRODUCTION OF RODENTS AND RODENT PRODUCTS
2. The Public Health Service (PHS) is responsible for regulations
involving the importation into the United States or distribution
after importation, of any etiologic agent or any arthropod or other
animal host or vector of human disease (see NIH Manual Chapter
1340-1, Permits for Import or Export of Biological Materials). A PHS
permit must be obtained for importation and/or distribution of these
materials. The Chief, QPSO, or his/her designee, is authorized to
issue PHS import permits.
3. The United States Fish and Wildlife Service (USFWS), United States
Department of Interior, is responsible for regulations involving the
prevention and control of wildlife diseases, and the importation of
wildlife or products derived from threatened or endangered wildlife
species. Permits for designated port exemptions are issued through
the QPSO.
4. Finally, the QPSO must be notified, and a USDA permit obtained, if
transgenic rodents, carrying receptors which enable those rodents to
develop productive infection with human pathogens, are imported into
the United States or transported within the United States by NIH
investigators (496-3353).
J. Additional Information.
For further information on this policy, contact the Rodent Import Officer,
Veterinary Resources Program, NCRR, on 402-2799 or the applicable ICD
Animal Program Director. Additional copies of this policy may be obtained
by submitting the request to Printing and Reproduction Branch (P&RB), DSS,
Stonestreet, Room 115.
For additional information on the importation or transportation of any
etiologic agent or host or vector of human or animal diseases, or the
importation of wildlife, contact the Quarantine Permit Service Office,
Division of Safety (496-3353).
Refer to paper copy for Appendix information.
NIH Manual 3043-1 (9/30/95) ATTACHMENT 8
<PAGE>
<TABLE>
<S><C>
Application for Permit to Introduce
Rodent and Rodent Produce
- -------------------------------------------------------------------------------------------------------------------------------
Department of Health and Human Services 1. Request Permit To (check one) 2. Mode of Transportation
Public Health Service
National Institutes of Health ___ Import into U.S.
___ Introduce from within U.S.
Application for Permit to Introduce -------------------------------------------------------------
Rodents and Rodent Products 3. Delivery Point (Port of entry, airport, city, state, etc.)
(Use prescribed by NIH Manual 3043-1)
INSTRUCTIONS: Send one copy of this form to veterinary Resources
Program, Building 28A, Room 111. Use additional sheets if needed.
- -------------------------------------------------------------------------------------------------------------------------------
4a. To (Name of requester) 4b. Institute 6. From (Individual's name, address, and phone no. of source)
- ------------------------------------------------------------------
4c. NIH Mailing Address (Bldg./Rm.) 4c. Phone No.
- ------------------------------------------------------------------
4e. FAX No. 5. CAN
- -------------------------------------------------------------------------------------------------------------------------------
7. Genus and species and Common Name(s), Color, Strain (if applicable), Tumor Line Designation (if applicable).
- -------------------------------------------------------------------------------------------------------------------------------
8a. Number of Animals to be Received 8b. Approximate Date of Arrival
Male: Female:
- -------------------------------------------------------------------------------------------------------------------------------
9. Origin and Brief History of the Source Colony or Tissue
- -------------------------------------------------------------------------------------------------------------------------------
10a. Medical History of the Originating Colony or Tissue. Attach the most recent health surveillance report, if available. Has
colony or tissue been checked for Ectromelia (mouse pox), Lymphocytic Choriomeningitis (LCM), or other murine viruses?
(If "yes", specify which agents were tested for, when, and results).
____ Yes ____ No ____ Unknown
- -------------------------------------------------------------------------------------------------------------------------------
10b. What diseases or parasites are known to be present in the originating colony?
- -------------------------------------------------------------------------------------------------------------------------------
10c. Other pertinent colony history
- -------------------------------------------------------------------------------------------------------------------------------
11. Name, title, address, and phone no. Of sending institution's facility veterinarian or other professional person responsible
for animal health and care:
- -------------------------------------------------------------------------------------------------------------------------------
12. Specific location at NIH animals or tissue will be housed and/or used
- -------------------------------------------------------------------------------------------------------------------------------
13. Special requirements for handling animals or tissue during the quarantine period
===============================================================================================================================
(right arrow) I certify that these animals or tissues will be used in accordance with all restrictions and precautions as may
be specified in the permit.
- -------------------------------------------------------------------------------------------------------------------------------
14. Signature of Requester 15. Degree(s) 16. Title 17. Date Signed
- -------------------------------------------------------------------------------------------------------------------------------
18. Signature of ICD Director 19. Date Signed
- -------------------------------------------------------------------------------------------------------------------------------
NIH 2369-1 (Rev. 10/91) ATTACHMENT 9
</TABLE>
<PAGE>
<TABLE>
<S><C>
Permit to Introduce Rodents and Rodent Products
- -------------------------------------------------------------------------------------------------------------------------------
Department of Health and Human Services | Permit Number
Public Health Service |
National Institutes of Health |
Permit to Introduce |------------------------------------------------------------------------------------
Rodents and Rodent Products | Date Issued Date Expires (for purposes of movement from
| shipper to permittee)
|
(Use prescribed by NIH Manual 3043-1) |
- -------------------------------------------------------------------------------------------------------------------------------
Name and Address of Source
- -------------------------------------------------------------------------------------------------------------------------------
To (Name and address of requester) | Mode of Transportation (requester must notify NCRR Rodent Import Office of shipping
| information.)
|
|
|
- ------------------------------------------|------------------------------------------------------------------------------------
Name and Address of Recipient | Delivery Point
(if other than requester) |
|
|------------------------------------------------------------------------------------
| Quarantine Location
|
|
- -------------------------------------------------------------------------------------------------------------------------------
As requested in your application, you are authorized to introduce the following rodents or rodent tissues:
===============================================================================================================================
Restrictions and Precautions for Transporting Rodents and Rodent Tissues
- -------------------------------------------------------------------------------------------------------------------------------
This permit is issued under the authority contained in NIH Manual 3043-1. The authorized rodents or rodent tissues or their
progeny shall be used only in accordance with the restrictions and precautions specified below. Alterations of restrictions can
be made only when authorized by the NCRR Rodent Import Office.
____ NCRR quarantine waived. ____NCRR quarantine required.
- -------------------------------------------------------------------------------------------------------------------------------
Comments
===============================================================================================================================
(right arrow) Signature of NCRR Rodent Import Officer | Date Signed
|
|
- -------------------------------------------------------------------------------------------------------------------------------
NIH 2369-2 (Rev. 10/91) ATTACHMENT 10
</TABLE>
<PAGE>
NIH/ADAMHA Patent Policy Board May 22,1989 (OTT rev 1017/910
National Institutes of Health
Alcohol, Drug Abuse and Mental Health Administration
MATERIAL TRANSFER AGREEMENT
---------------------------
This Material Transfer Agreement ("MTA") has been adopted for use by the
National Institutes of Health ("NIH") and the Alcohol, Drug Abuse and Mental
Health Administration (ADAMHA) in all transfers of research material ("Research
Material") whether NIH or ADAMHA is identified below as its Provider or
Recipient.
5. Provider agrees to transfer to recipient's investigator named below the
following Research Material:
- --------------------------------------------------------------------------------
2. THIS RESEARCH MATERIAL MAY NOT BE USED IN HUMAN SUBJECTS. This Research
Material will only be used for research purposes by Recipient's investigator in
his/her laboratory, for the Research Project described below, under suitable
containment conditions. This Research Material will not be used for commercial
purposes such as screening, production or sale, for which a commercialization
license may be required. Recipient agrees to comply with all Federal rules and
regulations applicable to the Research Project and the handling of the Research
Material.
2.(a) Are Research Materials of human origin? ____Yes ____No
2.(b) If Yes in 2.(a), were Research Materials collected according to 45
CFR 46 "Protection of Human Subjects?" ____Yes ____No. Please provide Assurance
Number: _______________.
3. This Research Material will be used by recipient's investigator solely
in connection with the following research project ('Research Project") described
with specificity as follows (use an attachment page if necessary:
________________________________________________________________________________
________________________________________________________________________________
4. In all oral presentations or written publications concerning the
Research Project, Recipient will acknowledge Provider's contribution of this
Research Material unless requested otherwise. To the extent permitted by law,
Recipient agrees to treat in confidence, for a period of three (3) years from
the date of its disclosure, any of Provider's written information about this
Research Material that is stamped "CONFIDENTIAL," except for information that
was previously known to recipient or that is or becomes publicly available or
which is disclosed to Recipient without a confidentiality obligation. Recipient
may publish or otherwise publicly disclose the results of the Research Project,
but if Provider has given CONFIDENTIAL information to Recipient such public
disclosure may be made only after Provider has had thirty (30) days to review
the proposed disclosure, except when a shortened time period under court order
or the Freedom of Information Act pertains.
5. This Research Material represents a significant investment on the part
of Provider, and is considered proprietary to Provider. Recipient's investigator
therefore agrees to retain control over this Research Material, and further
agrees not to transfer the Research Material to other people not under her or
his direct supervision without advance written approval of Provider. Provider
reserves the right to distribute the Research Material to others and to use it
for its own purposes. When the Research Project is completed, or three (3) years
have elapsed, whichever occurs first, the Research Material will be destroyed by
Recipient or otherwise disposed of as mutually agreed by Provider and Recipient.
6. This Research Material is provided as a service to the research
community. IT IS BEING SUPPLIED TO RECIPIENT WITH NO WARRANTIES, EXPRESS OR
IMPLIED, INCLUDING ANY
Material Transfer Agreement (NIH/ADAMHA) ATTACHMENT 11
<PAGE>
NIH/ADAMHA Patent Policy Board May 22, 1989 (0TT rev 1017/910
WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. Provider makes
no representations that the use of the Research Material will not infringe any
patent or proprietary rights of third parties.
7. When Provider is the NIH/ADAMHA: Recipient shall retain title to any
patent or other intellectual property rights in inventions made by its employees
in the course of the Research Project Recipient agrees not to claim, infer, or
imply Governmental endorsement of the Research Project, the institution or
personnel conducting the Research Project or any resulting commercial
product(s). Recipient agrees to hold the United States Government harmless and
to indemnify the Government for all liabilities, demands, damages, expenses and
losses arising out of Recipient's use for any purpose of the Research Material.
8. When Recipient is the NIH/ADAMHA: The NIH/ADAMHA shall retain tit e to
any patent or other intellectual property rights in, inventories made by its
employees in the course of the Research Project. The NIH/ADAMHA are not
authorized to promise rights in advance for inventions developed through this
Research Project, except under a Cooperative Research and Development Agreement
("CRADA") pursuant to the Federal Technology Transfer Act of 1986. Except as may
be accorded through Paragraph 9., below, Provider acquires no intellectual
property rights under this MTA, but may apply for license rights to any
patentable invention that might result from this Research Project. It is the
intention of NIH/ADAMHA that Provider not be liable to NIH/ADAMHA for any claims
or damages arising from NIH/ADAMHA's use of the Research Material; however, no
indemnification is provided or intended.
9. Pursuant to their "Policy Statement or Cooperative Research and
Development Agreements and Intellectual Property Licensing," NIH and ADAMHA may
permit their investigators to enter into CRADAs (and thereby promise an option
to acquire intellectual property rights) in exchange for the contribution of
"essential research materials ... not otherwise reasonably available." If the
Research Material transferred by this MTA is so certified below, Provider and
the NIH/ADAMHA (when Recipient) investigator should submit a formal CRADA for
NIH/ADAMHA approval. For nongovernmental entities that regularly provide
research materials to NIH or ADAMHA, it is suggested that a master CRADA be
negotiated under which a certification below will suffice to invoke the
provisions of the CRADA. If Provider and Recipient otherwise decide to engage in
a cooperative research or development project using the Research Material, a
formal CRADA must also be negotiated. For general inquiries regarding CRADAs or
NIH/ADAMHA technology transfer policies, contact the Office of Invention
Development at (301) 496-0750.
For receipt of Research Material under this Paragraph, when a master CRADA
governing material transfers is in effect between NIH or ADAMHA and Provider,
the NIH/ADAMHA investigator must identify the CRADA by NIH/ADAMHA reference
number: _________________________, and provide a more detailed description than
in Paragraph 2., above, of the specific extent of activities within the overall
Research Project to which the provisions of the CRADA will pertain (use an
attachment page if necessary). Signature by the investigator and authorized
official below constitutes certification that the Research Material transferred
by this MTA is essential and not otherwise reasonably available for the
following activities:
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
10. This MTA shall be construed in accordance with Federal law as applied
by the Federal courts in the District of Columbia.
11. Any additional ______________________________________________________
________________________________________________________________________________
________________________________________________________________________________
Material Transfer Agreement (NIH/ADAMHA) ATTACHMENT 11
<PAGE>
NIH/ADAMHA Patent Policy Board May 22, 1989 (OTT rev 1017/910
================================================================================
Date: _________________________ ____________________________________________
Recipient's Investigator and Title
Date: _________________________ ____________________________________________
Authorized signature for Recipient and Title
Recipient's mailing address: ___________________________________________________
________________________________________________________________________________
________________________________________________________________________________
Date: _________________________ ____________________________________________
Provider's Investigator and Title
Date: _________________________ ____________________________________________
Authorized signature for Provider and Title
Provider's mailing address: ____________________________________________________
________________________________________________________________________________
________________________________________________________________________________
Material Transfer Agreement (NIH/ADAMHA) ATTACHMENT 11
<PAGE>
(INVESTIGATOR'S NAME) WEEK ENDING: (DATE)
ANIMAL INVENTORY AND BREEDING RECORD
- --------------------------------------------------------------------------------
STRAIN DATE SOURCE NO. OF NO. DATE COMMENTS
OR CROSS RECEIVED MALES FEMALES BORN
- --------------------------------------------------------------------------------
(INFORMATION)
- --------------------------------------------------------------------------------
Animal Inventory and Breeding Record
November 1992
ATTACHMENT 12
<PAGE>
ANIMAL INVENTORY SUMMARY
WEEK ENDING: (DATE)
- --------------------------------------------------------------------------------
INVESTIGATOR MICE RATS RABBITS HAMSTERS
- --------------------------------------------------------------------------------
(INFORMATION)
- --------------------------------------------------------------------------------
PRESENT TOTALS:
Animal Inventory Summary
November 1992
ATTACHMENT 13
<PAGE>
<TABLE>
<CAPTION>
ANIMAL MORTALITY SHEET
WEEK ENDING: (DATE)
- --------------------------------------------------------------------------------------------------------
DATE DATE DATE STRAIN SOURCE SEX CAGE EAR TAG NUMBER INVESTIGATOR
REMOVED RECEIVED BORN NUMBER NUMBER DISCARDED
- --------------------------------------------------------------------------------------------------------
<S><C>
(INFORMATION)
- --------------------------------------------------------------------------------------------------------
Animal Mortality Sheet
November 1992
ATTACHMENT 13
</TABLE>
(10) (b) The Company's 1998 Stock Option Plan, adopted October 27, 1997.
<PAGE>
DIAGNON CORPORATION
-------------------
1998 STOCK OPTION PLAN
----------------------
1. GENERAL
1.1 This 1998 Stock Option Plan ("Plan") is intended to encourage the
ownership of Common Stock of the Diagnon Corporation (the
"Corporation") by eligible key employees of the Corporation and to
provide incentives for them to exert maximum efforts for the welfare of
the Corporation. By extending to key employees the opportunity to
acquire equity interests in the Corporation and to participate in its
success, this Plan is expected to benefit the Corporation and its
stockholders by making it possible for the Corporation to attract and
retain the best available talent and by rewarding key management and
technical personnel for their part in increasing the value of the
Corporation's shares. The Corporation also recognizes that it relies
heavily upon the contributions of independent consultants retained on a
regular basis and on the efforts of members of the Board of Directors
who are not employees. The Corporation also wishes to extend to these
consultants and directors the opportunity to acquire equity interests
in the Corporation and participate in its success. This Plan also is
intended to replace the Corporation's 1988 Stock Option Plan, as
amended (the "1988 Plan").
1.2 This plan shall have two (2) components: one component provides for
Incentive Stock Options ("Incentive Options") as defined in Section 422
of the Internal Revenue Code ("the Code"); and the other component
provides for Non-Qualified Stock Options ("Non-Qualified Options"),
which are not intended to be options as defined in Section 422 of the
Code. The Incentive Options and the Non-Qualified Options are sometimes
referred to together as the "Options." A participant who has been
granted an Incentive or a Non-Qualified Option may be granted an
additional Option or Options under this Plan.
1.3 This Plan was adopted by the Board of Directors of the Corporation
(the "Board") on July 17, 1997, subject to the approval of the
Corporation's shareholders.
2. STOCK SUBJECT TO THIS PLAN
There will be reserved for issue upon the exercise of Options up to 10
percent (539,824 shares) of the Corporation's Common Stock, par value one cent
($0.01), which may be unissued or reacquired shares. The Corporation, during the
terms of Options granted under this Plan, shall at all times keep available the
number of shares of stock required to satisfy the Options. If any Option
previously granted shall expire or terminate for any reason without having been
fully exercised, the unpurchased shares shall again become available for the
purposes of this Plan.
- 1 -
<PAGE>
3. INCENTIVE OPTIONS
3.1 All provisions of this Plan relating to Incentive Options shall be
administered by a committee (the "Incentive Committee"), consisting of
not fewer than two (2) Directors of the Corporation who shall be
disinterested within the meaning of Rule 16b-3 of the General Rules and
Regulations under the Securities Exchange Act of 1934, and who shall
serve at the pleasure of the Board. The determinations of the Incentive
Committee shall be made in accordance with their judgment as to the
best interests of the Corporation and its stockholders and in
accordance with the purposes of this Plan. No member of the Incentive
Committee shall be liable for any action taken or determination made in
good faith with respect to this Plan or any Incentive Option granted
hereunder. Subject to the provisions of this Plan and the requirements
of the Code with respect to Incentive Options, the Incentive Committee
shall have full authority to interpret this Plan with respect to
Incentive Options, to establish and amend rules and regulations
relating to Incentive Options, to determine the terms and provisions of
Incentive Option agreements (which need not be identical), and to make
all other determinations necessary or advisable for the administration
of Incentive Options granted under this Plan, including but not limited
to determining: (i) which eligible employees, officers, and directors,
of the Corporation shall be granted Incentive Options under this Plan;
(ii) the time or times, during the term of each Incentive Option,
within which all or portions of the Incentive Option may be exercised;
(iii) whether, on the date of exercise of an Incentive Option or
portion thereof, the recipient must pay the entire Incentive Option
price or only some part thereof, the balance to be paid within one year
from the date of exercise of the Incentive Option, provided that
payment tendered on the date of exercise equals or exceeds the
aggregate par value of the shares purchased; (iv) the number of shares
for which an Incentive Option or Incentive Options shall be granted;
and (v) generally all questions of policy and expediency that may
arise, including the correction of any defect or omission in this Plan
and the reconciliation of any inconsistency in this Plan or any
Incentive Option agreement in any manner and to the extent the
Incentive Committee shall deem necessary or expedient to make this Plan
fully effective. The Incentive Committee's interpretation, construction
and adoption of any provisions of this Plan relating to Incentive
Options or any Incentive Option granted hereunder shall be binding and
conclusive, unless otherwise determined by the Board. Any power that
may be exercised or action that may be taken by the Incentive Committee
under this Plan may also be exercised or taken by the Board. The Board
may, at any time by resolution, revoke the delegation of the Incentive
Committee and revest in the Board all or any part of the powers
hereinabove vested in the Incentive Committee.
3.2 Whenever the term "officers" is used in this Plan, such term shall
be deemed to include assistant officers of the Corporation and officers
of subsidiaries of the Corporation. The term "subsidiary" shall mean
any domestic or foreign corporation of which the Corporation owns,
directly or indirectly, at least fifty (50%) percent of the total
combined voting power of all classes of stock of such corporation. In
determining the
- 2 -
<PAGE>
employees to whom Incentive Options shall be granted and the number of
shares to be subject to purchase under such Incentive Options, the
Incentive Committee shall take into account the duties of the
respective employees, their present and potential contributions to the
success of the Corporation, and such other factors as the Incentive
Committee shall deem relevant in connection with accomplishing the
purposes of the Incentive Plan. Membership on the Board of Directors
shall not disqualify a person from receiving an Incentive Option grant
hereunder, although Directors who are members of the Incentive
Committee or who are not officers or managerial employees of the
Corporation or a subsidiary are not eligible to receive Incentive
Options under this Plan.
3.3 The exercise price of any Incentive Option granted to an employee
who at the time such Incentive Option is granted, owns, as defined in
Section 424 of the Code, stock possessing not more than ten (10%)
percent of the total combined voting power of all classes of stock of:
3.3.1 the Corporation; or
3.3.2 if applicable, any subsidiary of the Corporation
qualifying as a "Subsidiary Corporation" as defined in Section
424 of the Code (any such corporation being hereinafter
referred to as a "Subsidiary"); or
3.3.3 If applicable, any parent of the Corporation qualifying
as a "Parent Corporation" as defined in Section 424 of the
Code (any such corporation being hereinafter referred to as
the "Parent"),
shall be at least equal to the fair market value of the Common Stock at
the time of granting of the Incentive Option.
3.4 The exercise price of any Incentive Option granted to an employee
who, at the time such Incentive Option is granted, owns, as defined in
Section 424 of the Code, stock possessing more than (10%) percent of
the total combined voting power of all classes of stock of:
3.4.1 the Corporation; or
3.4.2 if applicable, a Subsidiary; or
3.4.3 if applicable, the Parent,
shall be at least equal to one hundred ten (110%) percent of the fair
market value of the Common Stock at the time of granting of the
Incentive Option.
- 3 -
<PAGE>
3.5 For all purposes of this Plan, the fair market value of the Common
Stock at the time of granting an Option shall be deemed to be the mean
between the high and the low prices of the Common Stock on the national
securities exchange on the day on which the Option is granted, if the
Common Stock is then being traded on a national securities exchange,
and if the Common Stock is then being traded on such an exchange but
there are no sales on such day, the fair market value shall be deemed
to be the mean between the high and low prices of the Common Stock on
the national securities exchange on the day on which the most recent
sales occurred prior to the date of grant, and if the Common Stock is
not then traded on such an exchange, then the fair market value shall
be deemed to be the mean between the high and low bid and asked prices
for the Common Stock on the over-the-counter market on the day on which
the option is granted. If the Common Stock is not publicly traded at
the time of the grant, the fair market value shall be determined in
good faith at the time of the grant of any Incentive Option by decision
of the Incentive Committee.
3.6 The date of grant of an Incentive Option granted hereunder shall be
the date on which the Incentive Committee acts in granting the
Incentive Option.
3.7 Incentive Options granted hereunder shall be exercisable for a term
of not more than ten (10) years from the date of grant thereof, but
shall be subject to Section 3.8 and to earlier termination as
hereinafter provided. Each Incentive Option agreement issued hereunder
shall specify the term of the Incentive Option, which term shall be
determined by the Incentive Committee in accordance with its
discretionary authority hereunder.
3.8 Notwithstanding anything herein to the contrary, in the event an
Incentive Option is granted to an employee who, at the time such option
is granted, owns, as defined in Section 424 of the Code, stock
possessing more than ten (10%) percent of the total combined voting
power of all classes of stock of:
3.8.1 the Corporation; or
3.8.2 if applicable, a Subsidiary; or
3.8.3 if applicable, the Parent,
then such Incentive Option shall not be exercisable more than five (5)
years from the date of grant thereof, but shall be subject to earlier
termination as hereinafter provided.
3.9 No Option will be treated as an Incentive Option to the extent that
the aggregate fair market value (determined at the time the Option is
granted) of the stock with respect to which the Option is exercisable
for the first time by any individual during any calendar year (under
all plans of the Corporation and any subsidiary) exceeds one hundred
thousand ($100,000) dollars.
- 4 -
<PAGE>
3.10 No person may receive Incentive Options prior to the date on which
employment of such person by the Corporation actually commences.
4. NON-QUALIFIED OPTIONS
4.1 All provisions of this Plan relating to Non-Qualified Options shall
be administered by the Compensation Committee (the "Compensation
Committee") appointed by the Board. The Compensation Committee shall
consist of not less than two (2) members of the Board. The
determinations of the Compensation Committee shall be made in
accordance with their judgment as to the best interests of the
Corporation and its stockholders and in accordance with the purposes of
this Plan. No member of the Compensation Committee shall be liable for
any action taken or determination made in good faith with respect to
this Plan or any Non-Qualified Option granted hereunder. Subject to the
provisions of this Plan and the requirements of the Code, the
Compensation Committee shall have full authority to interpret this Plan
with respect to Non-Qualified Options, to establish and amend rules and
regulations relating to Non-Qualified Options, to determine the terms
and provisions of Non-Qualified Option agreements (which need not be
identical), and make all other determinations necessary or advisable
for the administration of Non-Qualified Options granted under this
Plan, including but not limited to determining: (i) which eligible
employees, officers, directors, and consultants of the Corporation
shall be granted Non-Qualified Options under this Plan; (ii) the time
or times, during the term of each Non-Qualified Option, within which
all or portions of the Non-Qualified Option may be exercised; (iii)
whether, on the date of exercise of a Non-Qualified Option or portion
thereof, the recipient must pay the entire Non-Qualified Option price
or only some part thereof, the balance to be paid within one year from
the date of exercise of the Non-Qualified Option, provided that payment
tendered on the date of exercise equals or exceeds the aggregate par
value of the shares purchased; (iv) the number of shares for which a
Non-Qualified Option or Non-Qualified Options shall be granted; and (v)
generally all questions of policy and expediency that may arise,
including the correction of any defect or omission in this Plan and the
reconciliation of any inconsistency in this Plan or any Non-Qualified
Option agreement in any manner and to the extent the Committee shall
deem necessary or expedient to make this Plan fully effective. The
Compensation Committee's interpretation, construction and adoption of
any provisions of this Plan relating to Non-Qualified Options or any
Non-Qualified Option granted hereunder shall be binding and conclusive,
unless otherwise determined by the Board. Any power that may be
exercised or action that may be taken by the Compensation Committee
under this Plan may also be exercised or taken by the Board. The Board
may, at any time by resolution, revoke the delegation of the
Compensation Committee and revest in the Board all or any part of the
powers hereinabove vested in the Compensation Committee.
- 5 -
<PAGE>
4.2 The Compensation Committee and the Incentive Committee may be
combined into one (1) committee of the Board so long as the membership
requirements set forth herein for both committees are met by the
members of the combined committee.
4.3 Eligible recipients of Non-Qualified Options under this Plan shall
be Directors, officers, and selected employees and consultants of the
Corporation and its Subsidiaries. Recipients will be selected by the
Compensation Committee. The granting of a Non-Qualified Option under
this Plan shall not affect any outstanding stock option previously
granted to an optionee under this Plan or any other plan of the
Corporation.
4.4 On the date a Non-Qualified Option is granted, the exercise price
per share shall be such price that the Committee deems appropriate.
5. TERMS OF OPTION AND OPTION AGREEMENTS
5.1 Each Incentive Option granted to a person eligible to receive such
Incentive Option (a "Qualifying Optionee") shall be evidenced by a
written agreement (an "Incentive Option Agreement") which shall
expressly identify the Incentive Options as "Incentive Stock Options,"
i.e., Options within the meaning of Section 422 of the Code. Each
Non-Qualified Option granted to each other person eligible to receive
Non-Qualified Options hereunder shall be evidenced by a written
agreement (a "Non-Qualified Option Agreement") which shall expressly
identify the Non-Qualified options as other than "Incentive Stock
Options." Unless specifically identified herein as applicable to
Incentive Options, the provisions of this Plan shall apply to both
Incentive Options and Non-Qualified Options. Each Incentive Option
Agreement and each Non-Qualified Option Agreement shall: (a) be in such
form and contain such provisions as the Board or the Committee shall
from time to time deem appropriate, and (b) include in substance, by
appropriate language, all of the applicable following provisions.
5.2 The Option may be granted at any time within ten (10) years from
the earlier of the date on which this Plan is approved by the
stockholders or was adopted by the Corporation's Board of Directors.
5.3 Incentive Options granted under this Plan to a Qualifying Optionee
are not required to be exercised in the order in which they are
granted.
5.4 An Option may not be exercised, to any extent, either by the person
to whom it was granted or by any person after his death, unless the
person to whom the Option was granted has remained in the continuous
employ of the Corporation, or has been a consultant to or director of
the Corporation, for not less than six months from the date of the
grant.
- 6 -
<PAGE>
5.5 A Qualifying Optionee may not dispose of shares acquired through
exercise of an Incentive Option (i) within two (2) years from the date
of the granting of the Incentive Option or (ii) within one (1) year
after the transfer of the shares to him by the Corporation and qualify
for the tax treatment provided by Section 421(a) of the Code.
5.6 The Corporation will seek from every regulatory commission or
agency having jurisdiction such authority as may be required to issue
and sell shares of stock to satisfy the Options. The Corporation's
inability to obtain from any such regulatory commission or agency
authority which counsel for the Corporation deems necessary for the
lawful issuance and sale of the Corporation's stock to satisfy the
Options, shall relieve the Corporation from any liability for failure
to issue and sell stock to satisfy otherwise properly exercised Options
until such time as such authority is obtained or is obtainable.
5.7 Neither a person to whom an Option is granted nor his legal
representative, heir, legatee or distributee, shall be deemed to be a
holder of, or to have any of the rights of a holder with respect to,
any shares subject to such Option unless and until he has exercised his
Option in complete accordance with the terms thereof.
5.8 An Option shall not be transferable except by will or by the laws
of descent and distribution. During the lifetime of the person to whom
the Option is granted, he alone may exercise it.
5.9 An Incentive Option granted to a Qualifying Optionee shall
terminate if the person to whom it is granted ceases to be continuously
employed by the Corporation, except (i) if such person's employment is
terminated for a reason other than death, permanent or total disability
(within the meaning of Section 22(e)(3) of the Code) or dismissal for
cause, he may exercise his Incentive Option to the extent that he was
entitled to do so at the date of his termination at any time within
three (3) months following the date of such termination; (ii) if his
continuous employment is terminated for reason of permanent or total
disability (within the meaning of Section 22(e)(3) of the Code), he or
his legal representative, in the event the employee is legally
incapable of doing so, may exercise his Incentive Option to the extent
that he was entitled to do so at the date of his termination at any
time within one (1) year following the date of such termination; or
(iii) if his continuous employment is terminated by death or the
employee's death occurs within three(3) months of his termination of
employment, such termination being for reason other than dismissal for
cause, his Incentive Option may be exercised at any time within one (1)
year following his death by the person or persons to whom his rights
under the Incentive Option shall pass by will or by the laws of descent
or distribution, but only to the extent that such Incentive Option was
exercisable by him on the date of termination of his employment.
Nothing in this paragraph is intended to extend the stated term of the
Incentive Option and in no event may an Option be exercised by anyone
after the expiration of its stated term.
- 7 -
<PAGE>
5.10 Nothing in this Plan or in any Option granted hereunder shall
confer on any Optionee any right to continue in the employ of the
Corporation or to interfere in any way with the right of the
Corporation to terminate his employment at any time. In the event that
the Corporation has not registered the shares with respect to which
Options are being exercised under the Securities Act of 1933, as
amended, each Optionee electing to purchase shares will be required to
represent that he is acquiring such shares for investment purposes only
and not with a view to the sale or distribution thereof and to make
such other representations as are deemed necessary by counsel to the
Corporation. Stock certificates evidencing such unregistered shares
acquired upon exercise of Options shall bear a restrictive legend
(unless, in the opinion of counsel for the Corporation, such a legend
is not necessary) stating as follows:
The shares represented by this certificate have not been
registered under the Securities Act of 1933. The shares have
been acquired for investment and may not be pledged or
hypothecated and may not be sold or transferred in the absence
of an effective registration statement for the shares under
the Securities Act of 1933 or an opinion of counsel
satisfactory to the Corporation that registration is not
required under said Act.
5.11 If the Corporation shall at any time change the number of shares
of its Common Stock without new consideration to the Corporation (such
as by stock dividends or stock splits), the aggregate number of shares
which may be issued pursuant to Options granted under this Plan and the
total number of shares then remaining subject to purchase under an
outstanding Option shall be changed in proportion to such change in
issued shares. The Option price per share also shall be adjusted so
that the total consideration payable to the Corporation upon the
purchase of all shares not theretofore purchased shall not be changed.
5.12 If, during the term of any outstanding Option, the Corporation
shall issue other securities of the Corporation or distribute other
property (other than cash) as a distribution or dividend on or in
exchange for Common Stock of the Corporation, the Corporation shall
take such steps as the Incentive Committee, the Compensation Committee,
and the Board deem appropriate: (a) equitably to adjust the kind and
amount of securities then remaining subject to purchase thereunder and
the exercise price per share; or (b) equitably to adjust the rights of
the optionee thereunder in order to reflect such issuance or
distribution of securities or other property.
5.13 If, during the term of an outstanding Option, the Common Stock of
the Corporation shall be changed into another kind of security of the
Corporation or into cash, securities, or evidences of indebtedness of
another corporation, other property or any combination thereof, as a
result of a reorganization, sale, merger, consolidation, or other
similar transaction, the optionee shall be entitled to receive, at the
election of the optionee (a) upon the due exercise of the Option or (b)
upon the effective date of the
- 8 -
<PAGE>
reorganization, sale, merger, consolidation or similar transaction, the
cash, securities, evidences of indebtedness, other property or any
combination thereof the optionee would have been entitled to receive
for Common Stock acquired through exercise of the Option (net of the
exercise price) immediately prior to the effective date of such
reorganization, sale, merger, consolidation or other similar
transaction. If appropriate, the exercise price of the shares or
securities remaining subject to purchase following such reorganization,
sale, merger, consolidation or other similar transaction may be
adjusted in each case in such equitable manner as the relevant
Committee and the Board may determine.
6. LIMIT ON STOCK SUBJECT TO OPTIONS
6.1 No Option may be granted under this Plan if the number of shares
that may be issued upon the exercise of that Option, when added to the
number of shares that may be issued (i) upon the exercise of unexpired
options already granted under the 1988 Plan, and (ii) upon the exercise
of unexpired Options already granted under this Plan, would exceed ten
(10%) percent of the then issued and outstanding Common Stock of the
Corporation.
6.2 The aggregate fair market value (determined at the time Options are
granted) of stock with respect to which Incentive Options are
exercisable for the first time by a Qualifying Optionee during any
calendar year shall not exceed one hundred thousand ($100,000) dollars.
7. LISTING REQUIREMENTS
The Corporation shall not be required to issue or deliver any
certificate for shares of its stock purchased upon the exercise of any Option
issued under this Plan prior to the admission of such shares to listing on any
stock exchange on which the stock may at that time be listed; provided, however,
that the Corporation shall take all necessary steps to secure the admission of
such stock to listing on any such stock exchange and shall secure admission of
such shares at the earliest practicable date.
8. TIME OF GRANTING OPTION
The date on which an Option shall be deemed granted shall be the date
on which a majority of the members of the Board or the Committee shall, at a
meeting, make such determination.
9. AMENDMENT OF THE PLAN
9.1 The Board or the Incentive Committee or the Compensation Committee,
as the case may be, may, at any time, amend this Plan; provided,
however, that no amendment
- 9 -
<PAGE>
shall be made, except upon approval by a majority of the shares of the
Corporation entitled to vote and voting in person or by proxy at a
meeting of the Corporation's stockholders, which will:
9.1.1 increase the number of shares reserved for Options under
this Plan; or
9.1.2 change in substance the provisions designating the
employees eligible to receive and exercise Incentive Options
under this Plan.
9.2 The rights and obligations created under any Option granted before
amendment of this Plan shall not be altered or impaired by such
amendment without consent of the person to whom the Option was granted
or to whom rights under an Option shall have passed by will or by laws
of descent or distribution.
10. TERMINATION OR SUSPENSION OF THE PLAN
10.1 The Board may at any time suspend or terminate this Plan. This
Plan, unless sooner terminated, shall terminate upon the earlier of ten
(10) years (i) from the date on which this Plan is approved by the
stockholders, or (ii) the date on which this Plan is adopted by the
Corporation's Board of Directors.
10.2 This Plan will also terminate if Incentive Options are exercised
for all the Common Stock reserved for issuance under this Plan. An
Option may not be granted while this Plan is suspended or after it is
terminated.
10.3 The rights and obligations created under any Option granted while
this Plan is in effect shall not be altered or impaired by suspension
or termination of this Plan, except with the consent of the person to
whom the Option was granted. The termination of this Plan shall not
affect any restrictions previously imposed on shares issued pursuant to
this Plan.
11. EFFECTIVE DATE
This Plan shall be deemed adopted upon the earlier of (i) approval by
vote of the holders of the majority of the shares of the Corporation entitled to
vote and voting in person or by proxy on the matter, or (ii) the date on which
this Plan is adopted by the Corporation's Board of Directors. This Plan shall
not be effective (and no Options can be granted), however, until it is approved
by vote of the holders of the majority of shares of the Corporation entitled to
vote and voting in person or by proxy on the matter.
- 10 -
<TABLE> <S> <C>
<ARTICLE> 5
<MULTIPLIER> 1
<CURRENCY> U.S. DOLLARS
<S> <C>
<PERIOD-TYPE> 6-MOS
<FISCAL-YEAR-END> MAY-31-1998
<PERIOD-START> JUN-01-1997
<PERIOD-END> NOV-30-1997
<EXCHANGE-RATE> 1
<CASH> 64,168
<SECURITIES> 0
<RECEIVABLES> 1,484,229
<ALLOWANCES> 0
<INVENTORY> 56,388
<CURRENT-ASSETS> 1,756,887
<PP&E> 3,902,123
<DEPRECIATION> 2,325,332
<TOTAL-ASSETS> 4,412,027
<CURRENT-LIABILITIES> 972,678
<BONDS> 0
0
0
<COMMON> 16,004
<OTHER-SE> 3,221,599
<TOTAL-LIABILITY-AND-EQUITY> 4,412,027
<SALES> 6,653
<TOTAL-REVENUES> 4,644,761
<CGS> 24,422
<TOTAL-COSTS> 4,730,260
<OTHER-EXPENSES> 0
<LOSS-PROVISION> 0
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</TABLE>
