FORM 10-QSB
SECURITIES EXCHANGE COMMISSION
Washington, D. C. 20549
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d)
OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended
March 31, 1998
Commission file number:
333-26269 SB-2
INTERNATIONAL ISOTOPES INC.
(Exact name of registrant as specified in its charter)
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<CAPTION>
Texas 74-2763837
<S> <C>
(State of incorporation) (IRS Employer Identification Number)
3100 Jim Christal Rd.
Denton,
Texas 76207
(Address of principal executive offices) (zip code)
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940-484-9492
(Registrant's telephone number, including area code)
Indicate by check mark whether the registrant (1) has filed all reports required
to be filed by Section 13 or 15 (d) of the Securities Exchange Act of 1934
during the preceding 12 months (or for such shorter period that the registrant
was required to file such reports), and (2) has been subject to such filing
requirements for the past 90 days. YES x NO
As of March 31,1998 the aggregate market value of the common stock of the
registrant held by non-affiliates of the registrant as determined by reference
to the closing price of Common Stock as reported on the Nasdaq Small Cap Market
System, was $108,069,719. As of March 31, 1998 the number of shares of common
stock, $.01 par value, outstanding was 6,370,950.
*Registrant became subject to the filing requirements of the Securities Exchange
Act of 1934 on August 14, 1997, when its Registration Statements on Form SB-2
and Form 8-A were declared effective by the Commission.
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INTERNATIONAL ISOTOPES INC.
TABLE OF CONTENTS
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Page No.
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PART I - FINANCIAL INFORMATION:
Item 1 - Financial Statements:
Condensed Consolidated Balance Sheets at March 31, 1998 3
(unaudited) andDecember 31, 1997
Condensed Consolidated Statements of Operations for the 4
Three Months Ended March 31, 1998 and 1997 and for the
period from November 1, 1995 (inception) through
March 31, 1998.
Condensed Consolidated Statements of Cash Flows for the Three 5
Months Ended March 31, 1998 and 1997 and for the
period from November 1, 1995 (inception) through
March 31, 1998.
(1) Notes to Condensed Consolidated Financial Statements (unaudited). 7
Item 2 - Management's Discussion and Analysis of Financial 9
Condition and Results of Operations
PART II - OTHER INFORMATION:
Item 5. Other Information 13
Item 6. Exhibits and Reports on Form 8-K 14
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INTERNATIONAL ISOTOPES INC. AND SUBSIDIARY
(development stage enterprises)
Condensed Consolidated Balance Sheets
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<CAPTION>
Assets March 31, December 31,
------ 1998 1997
(unaudited)
------------ ------------
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Current assets:
Cash and cash equivalents $ 8,530,554 $ 8,201,417
Securities available for sale, at fair value 277,803 5,082,777
Interest receivable 61,143 152,358
Accounts receivable 50,000 --
Assets held for sale 537,577 564,932
Inventory 748,853 741,853
Other 61,725 97,941
------------ ------------
Total current assets 10,267,655 14,841,278
Property, plant and equipment, net:
Property consisting of land 663,674 563,674
Plant and improvements 4,767,018 2,871,266
Furniture and equipment 5,146,747 2,845,820
------------ ------------
Total property, plant and equipment, net 10,577,439 6,280,760
------------ ------------
Total assets $ 20,845,094 $ 21,122,038
============ ============
Liabilities and Stockholders' Equity
------------------------------------
Current liabilities:
Accounts payable $ 614,056 $ 906,062
Accrued liabilities 598,061 602,064
Current installments of mortgage and notes payable to banks 649,992 634,454
------------ ------------
Total current liabilities 1,862,109 2,142,580
Mortgage and notes payable to banks, excluding current installments 3,645,378 3,053,818
------------ ------------
Total liabilities 5,507,487 5,196,398
Stockholders' equity:
Preferred stock, $1.00 par value; 5,000,000 shares authorized,
no shares issued and outstanding -- --
Common stock, $.01 par value; 20,000,000 shares authorized;
issued and outstanding 6,370,950 shares 63,709 63,709
Additional paid-in capital 21,787,337 21,787,337
Deficit accumulated during the development stage (5,793,439) (5,205,406)
Receivable from stock sales (720,000) (720,000)
------------ ------------
Total stockholders' equity 15,337,607 15,925,640
------------ ------------
Total liabilities and stockholders' equity $ 20,845,094 $ 21,122,038
============ ============
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See accompanying notes to consolidated financial statements.
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INTERNATIONAL ISOTOPES INC. AND SUBSIDIARY
(development stage enterprises)
Condensed Consolidated Statements of Operations
(Unaudited)
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<CAPTION>
Period from
November 1,
1995
(inception)
Qtr. Ended Qtr. Ended through
March 31, March 31, March 31,
1998 1997 1998
----------- ----------- -----------
<S> <C> <C> <C>
Development contract income $ 150,000 $ -- $ 150,000
Sale of accelerator components -- 128,072 910,889
Cost of development (62,830) -- (62,830)
Cost of accelerator components -- (65,656) (342,749)
----------- ----------- -----------
Gross Profit 87,170 62,416 655,310
Operating costs and expenses:
Salaries and contract labor 242,321 677,907 1,276,936
Employee incentive compensation -- -- 2,397,500
Sales and Marketing 116,488 -- 116,488
General and administrative 363,648 63,422 1,321,438
Consulting fees 31,527 3,459 467,130
Legal and professional fees 40,502 1,227 135,950
Rent and security 4,591 46,740 285,224
Commissions and fees -- -- 95,315
Taxes 15,000 -- 15,000
Other -- 19,832 102,567
----------- ----------- -----------
Total operating expenses 814,077 812,587 6,213,548
----------- ----------- -----------
Loss from development stage operations (726,907) (750,171) (5,558,238)
Other income (expense):
Gain on sale (donation) of assets held for sale (20,332) -- 331,006
Interest income 159,206 423 461,947
Interest expense -- (83,316) (528,154)
Loan financing fees (750,000)
----------- ----------- -----------
Loss before extraordinary item (588,033) (833,064) (6,043,440)
Extraordinary gain on debt extinguishment -- -- 250,000
----------- ----------- -----------
Net loss $ (588,033) $ (833,064) $(5,793,439)
=========== =========== ===========
Net loss per common share - basic and diluted $ (.09) $ (0.21) $ (1.37)
----------- ----------- -----------
Weighted average common shares outstanding -
basic and diluted 6,407,407 3,944,002 4,204,281
=========== =========== ===========
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See accompanying notes to condensed consolidated financial statements.
<PAGE>
INTERNATIONAL ISOTOPES INC. AND SUBSIDIARY
(development stage enterprises)
Condensed Consolidated Statements of Cash Flows
(unaudited)
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<CAPTION>
Period from
November 1,
1995
(inception)
Qtr. Ended Qtr. Ended through
March 31, March 31, March 31,
1998 1997 1998
------------ ------------ ------------
<S> <C> <C> <C>
Cash flows from operating activities:
Net loss $ (588,033) $ (833,064) $ (5,793,439)
Adjustments to reconcile net loss to net cash used
in operating activities:
Depreciation and amortization 10,622 1,821 29,636
(Gain) donation on sale of assets 20,332 (331,006)
Services compensated by stock issuance -- 62,852 2,178,886
Changes in operating assets and liabilities:
Interest receivable 91,215 -- (61,143)
Accounts receivable (50,000) -- (50,000)
Other current assets 36,216 (183,491) (61,725)
Inventory (7,000) 58,019 (748,853)
Accounts payable (292,006) (19,398) 41,325
Accrued liabilities (4,003) 610,961 598,061
------------ ------------ ------------
Net cash used in operating activities (782,657) (302,300) (4,198,258)
Cash flows from investing activities:
Proceeds from sale of certificate of deposit -- -- 400,000
Purchase of certificate of deposit -- -- (400,000)
Purchase of assets for sale and operations (4,300,278) (89,591) (10,883,898)
Purchase of securities available for sale -- (5,082,777)
Proceeds from sale of securities available for sale 4,804,974 -- 4,804,974
Proceeds from sale of assets held for sale -- -- 817,938
------------ ------------ ------------
Net cash provided (used) in investing activities 504,696 (89,591) (10,343,763)
Cash flows from financing activities:
Collections of stock sale receivable -- -- 160,000
Proceeds from issuance of notes payable to chairman -- 120,000
Proceeds from sale of common stock -- 260,000 18,612,205
Proceeds from issuance of debt 608,228 642,000 12,559,835
Principal payments on notes payable (1,130) (745,110) (8,264,465)
Payments on notes payable to chairman -- -- (115,000)
------------ ------------ ------------
Net cash provided by financing activities 607,098 156,890 23,072,575
Net increase (decrease) in cash and cash equivalents 329,137 (235,001) 8,530,554
Cash and cash equivalents at beginning of period 8,201,417 331,397 --
------------ ------------ ------------
Cash and cash equivalents at end of period $ 8,530,554 $ 96,396 $ 8,530,554
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(Continued)
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INTERNATIONAL ISOTOPES INC. AND SUBSIDIARY
(development stage enterprises)
Condensed Consolidated Statements of Cash Flows
(unaudited)
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<CAPTION>
Period from
November 1,
1995
(inception)
Qtr. Ended Qtr. Ended through
March 31, March 31, March 31,
1998 1997 1998
------- ------ -------
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Supplemental disclosure of cash flow activities:
Cash paid for interest $79,499 57,515 612,935
======= ====== =======
Cash paid for financing fees $ 1,600 5,045 511,861
======= ====== =======
Supplemental disclosure of noncash transactions:
Conversion of notes payable to common stock $ -- -- 5,000
======= ====== =======
Acquisition of subsidiary through issuance of 75,003
common stock $ -- -- 75,003
======= ====== =======
Acquisition of patent through issuance of common
Stock $ -- -- 100
======= ====== =======
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See accompanying notes to condensed consolidated financial statements.
<PAGE>
INTERNATIONAL ISOTOPES INC. AND SUBSIDIARY
(development stage enterprises)
Notes to Condensed Consolidated Financial Statements
(Unaudted)
(1) The Company and Basis of Presentation
International Isotopes Inc. (the "Company" or "I(3)") was incorporated on
November 15, 1995 and is a development stage enterprise. The Company's primary
activities have been to obtain assets to be used in the production of
radioisotopes and to obtain funding to complete the reconfiguration and
reassembly of the linear accelerator.
The accompanying unaudited consolidated financial statements include the results
of operations of the Company and its wholly owned subsidiary, Gazelle Realty.
All significant intercompany accounts and transactions have been eliminated in
consolidation. The unaudited financial statements included herein by the Company
have been prepared without audit and in accordance with generally accepted
accounting principles, and have been prepared pursuant to the rules and
regulations of the Securities and Exchange Commission (SEC). These statements
reflect all adjustments which, in the opinion of management, are necessary for a
fair presentation of the Company's financial position as of March 31, 1998 and
December 31, 1997, and the results of its operations for the three months ended
March 31, 1998 and 1997 and its cash flows for the three months ended March 31,
1998 and 1997. This information should be read in conjunction with the Company's
audited consolidated financial statements as of and for the period from November
1, 1995 (inception) through December 31, 1997 as set out in the Company's
Form10-KSB filed March 31, 1998.
Certain information in footnote disclosures, normally included in the financial
statements were prepared in accordance with generally accepted accounting
principles, and have been condensed or omitted pursuant to the rules and
regulations. The financial data disclosed in the notes to the consolidated
statements are unaudited for these periods.
(2) Net Loss Per Common Share - Basic and Diluted
In February 1997, the Financial Accounting Standards Board issued Statement of
Financial Accounting Standards No. 128, Earnings per Share ("SFAS No. 128").
SFAS No. 128 revised the previous calculation methods and presentations of
earnings per share under APB 15 and requires that all prior-period earnings
(loss) per share data be restated. The Company adopted SFAS No. 128 in the
fourth quarter of 1997 as required by this Statement. In accordance with SFAS
No. 128, the Company has presented basic loss per share, computed on the basis
of the weighted average number of common shares outstanding during the period.
Diluted loss per share, which is computed on the basis of the weighted average
number of common shares and all potentially dilutive common shares outstanding
during the period, is the same as basic loss per share, as all were
anti-dilutive securities.
Pursuant to the SEC staff accounting bulletin and SEC Staff policy, common stock
issued during the twelve-month period prior to the Offering for consideration
below the Offering price have been included in the calculation of weighted
average number of shares as if they were outstanding for all periods presented.
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(3) Mortgage and Notes Payable to Banks
As of March 31, 1998, mortgage and notes payable to banks consisted of five
loans: (a) an interim construction loan on a building located at Spencer Road in
Denton, Texas the amount of $920,823 secured by building and land, with a
current rate of 8.5%, (b) a one year term loan in the amount of $500,000, (c) a
revolving line of credit having a maximum amount of $250,000 and a current
balance of $81,196, both secured by 20 acres of land in Denton, Texas, upon
which the Company is currently constructing the Radioisotope Production
Facility, with variable rates currently at 8.5%, (d) an amortizing loan for
$2,473,351 that is secured by the land and building at Jim Christal Road in
Denton, Texas with final payment due April 22, 2018 and a rate of 8.5%, and (e)
an amortizing fifteen year loan in the amount of $320,000 which is secured by
the Superconducting Super Collider ("SSC") project land and buildings in
Waxahachie, Texas with a variable rate at March 31, 1998 of 8.5%.
(4) Common Stock
On August 19, 1997, the Company completed an offering of 2,200,000 shares of its
Common Stock at $9.00 per shares. The Company received proceeds of $17,805,823
after deducting underwriters' discounts and commissions. Additional costs
associated with the offering due to legal, audit, printing and other expenses
were $898,117 resulting in net proceeds of $16,907,706. On September 30, 1997
the Company completed the sale of an additional 100,000 shares of its Common
Stock. In December 1997, the Company issued 155,000 shares of its Common Stock
to four key employees. There were no stock transactions during the three months
ended March 31, 1998. Common Stock shares outstanding at March 31, 1998 totaled
6,370,950.
(5) Stock Options
During the three month period ended March 31, 1998, the Company granted options
to purchase 30,800 shares of Common Stock to fifteen employees under the terms
specified in the Company's 1997 Long Term Incentive Plan. The plan authorizes
grants of options to purchase up to 600,000 shares to officers, employees and
consultants. Common Stock options outstanding at March 31, 1998 totaled 377,700.
(6) Building Purchase
On March 4, 1998 the Company purchased from the State of Texas 115 acres of land
and a 30,000 square foot building in Waxahachie, Texas, the former site of the
SSC, for $400,000. The Company financed the purchase through a $320,000, 15-year
prime rate note with Citizens National Bank of Waxahachie. The property will be
used as a secondary accelerator production and testing site.
(7) Development Income
During January 1998, the Company entered into a contract with Imagyn Medical
Technologies for development and manufacturing of radioisotope permanent implant
seeds for the treatment of cancer and other diseases, a process known as
brachytherapy. The contract includes a $1,000,000 development fee to be paid to
the Company and provides for an exclusive three year supply contract with
expected purchases by Imagyn per year anticipated to generate revenues for I(3)
of approximately $9,000,000 over the life of the contract.
<PAGE>
(8) Subsequent Events
On April 24, 1998, Company completed the acquisition of MAC Isotopes, Inc. from
its parent corporation, MACTEC, Inc., of Golden Colorado and then merged MAC
Isotopes into International Isotopes Idaho Inc, a newly formed subsidiary of the
Company. The Company exchanged 159,416 shares of its unregistered Common Stock,
valued at $3,173,973 for 100% of the stock in MAC Isotopes. Upon consummation of
the acquisition, the Company loaned $500,000 to MAC Isotopes, Inc. to pay
liabilities owed to MACTEC, Inc. International Isotopes Idaho Inc, incorporated
in Texas (formerly MAC Isotopes, Inc.), assumed MAC Isotopes' exclusive five
year long-term contract, with an option to renew for three additional years, for
the utilization of the Department of Energy Advanced Test Reactor facility
located near Idaho Falls, Idaho. This purchase will be accounted for under the
purchase method of accounting. Activities conducted at this location include the
production of high specific activity medical radioisotopes to be used in
diagnostics and therapy of cancer and various diseases.
On April 20, 1998, I(3) awarded a contract in the amount of $393,614, to Black
and Veatch, LLP of Kansas City, Kansas to perform validation services in
accordance with an approved Master Validation Plan for the Company's
radiopharmacy. Black & Veatch will be validating utility systems and process
equipment as well as the processes to be utilized in the manufacture of I(3)
products. The validation services will include the development documentation
necessary to produce products and secure the required FDA validation for the
Company's radiopharmaceutical facility.
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
Except for historical information contained herein, the following contains
forward-looking information that is subject to certain risks and uncertainties.
The Company's actual results could differ materially from those anticipated in
these forward-looking statements as a result of certain factors, set forth in
the "Risk Factors" section included in the Company's Form 10-KSB filed with the
Securities Exchange Commission (SEC) on March 31, 1998. The following discussion
should be read in conjunction with "Management's Discussion and Analysis of
Financial Condition and Plan of Operations" included in the Form 10-KSB.
Overview
International Isotopes Inc., a Texas corporation, is a development stage company
that is executing plans to be the first commercial domestic producer of a full
range of radioisotopes, pharmaceutical grade radioisotopes and finished
radiopharmaceuticals (on a contract or joint venture basis) for commercial sale
to the nuclear medicine industry for the diagnosis and treatment of cancer and
other diseases. The Company is also developing instrumentation for radiation
therapy and medical imaging.
<PAGE>
Radioisotopes, indispensable components of nuclear medicine, are radiation
emitting atoms that are used for both medical diagnostics and in-the-body ("in
vivo") therapeutics. When a specifically selected radioisotope is attached or
"tagged" to one of a variety of pharmaceuticals, the resulting product is known
as a radiopharmaceutical. The pharmaceutical component acts as a carrier to seek
out targeted internal organs, tumor sites and/or cells for which it has a
predetermined natural affinity. In diagnostics, the radioisotope component
provides a signal as to the location of the attached pharmaceutical as it
targets the specific organ or site. This process, in turn, is captured by
external imaging equipment such as positron emission tomography ("PET") and
single photon emission computed tomography ("SPECT") cameras. In therapeutics,
the radioisotope component provides in vivo treatment of the targeted organ,
cancerous tumor and/or cancerous cell site through the emission of either
photons or beta radiation. In addition to radiopharmaceutical applications,
radioisotopes may also be injected into the body at the site of a tumor as part
of a medical device. This process is known as brachytherapy. Radioisotopes are
produced commercially either by an accelerator (a cyclotron or a linear
accelerator) or a nuclear reactor. Accelerators are machines, which accelerate
charged particles, generally protons, to bombard a stable (non-radioactive)
isotope target, causing a reaction such that the target is transformed into a
radioactive isotope. A nuclear reactor produces radioisotopes by bombarding a
stable isotope target with neutrons.
Presently, the most commonly used radioisotopes in the United States, such as
molybdenum-99 ("Mo-99"), thallium-201, gallium-67, indium-111 and palladium-103,
which the Company intends to commercially produce, are produced by four domestic
radiopharmaceutical companies, primarily for their own use, and by two foreign
manufacturers, and are used either independently or in various combinations or
"cocktails" to assist in the diagnosis of a myriad of medical conditions,
including coronary heart disease, pulmonary embolism, thyroid carcinoma, bone
cancer, brain disorders, acute cholecystitis (inflammation of the gall bladder),
gastrointestinal bleeding, renal artery stenosis and other diseases.
Since its incorporation in November 1995, the Company's operations have been
concentrated in acquiring its proton linear accelerator ("LINAC") and related
assets, redesigning and reconfiguring the LINAC for production of radioisotopes,
acquiring land, designing and constructing facilities for the production and
distribution of radioisotopes, radiopharmaceuticals and brachytherapy products,
raising capital, selling certain accelerator components and excess equipment and
entering into strategic alliances with medical and pharmaceutical companies,
universities and other institutions.
In November 1997, the Company acquired two buildings and twelve acres of land in
Denton, Texas, and relocated all personnel and equipment to this location in
December 1997. Also in December 1997, the Company installed a CP-42 Cyclotron
donated by M.D. Anderson Hospital to the University of North Texas at this site.
This machine, which will be operated by the Company under a lease agreement with
the university, is being rebuilt for use in the production of short-lived
isotopes. On February 5, 1998 the Company entered into a contract with MSS Clean
Technology in the amount of $2,014,793 for the construction of pharmaceutical
processing modular rooms to be located in this facility.
The Company is currently constructing a 35,000 square foot Radioisotope
Production Facility which will house the LINAC and radiochemistry processing.
The Radioisotope Production Facility is being constructed on 20.16 acres of land
the Company has acquired in a 500-acre high technology biomedical research
industrial park located in Denton, Texas, known as the "North Texas Research
Center." Due to a shortage of concrete, weather delays and delays in receipt of
final construction drawings, initial occupancy of the tunnel is anticipated in
July, and occupancy of the radiochemistry portion of the building is expected in
to occur in September with production thirty to forty-five days thereafter.
<PAGE>
Upon full operation of the Radioisotope Production Facility and the LINAC in
conformity with the Company's redesign and reconfiguration, the Company intends
to produce currently used radioisotopes and the upcoming and potentially
superior diagnostic and therapeutic pharmaceutical grade radioisotopes which can
be cost effectively be accelerator-produced with the high energy (70 MeV) and
the 1.0mA beam intensity of the LINAC.
The Company has received additional authorizations from the Texas Department of
Health to perform certain preliminary functions. These include authorization to
transfer the permit for an authorized use location to 3100 Jim Christal Road;
authorization to handle and clean certain cyclotron components that contain low
levels of radioactive contamination; authorization to possess and use small
radioactive sealed sources used to calibrate radiation detection
instrumentation; and authorization to produce an internal beam in the cyclotron
for initial acceptance testing.
The Company has also submitted a license application to the Texas Department of
Health to obtain authorization to possess, manufacture and distribute
radiochemical and radiopharmaceuticals and has had satisfactory preliminary
discussions with the regional and national offices of the FDA concerning the
construction and validation of its radiopharmaceutical manufacturing facility.
The Company has entered into a development and manufacturing contract with
Imagyn Medical Technologies Inc. to provide I-125 and Pd-103 brachytherapy
seeds. The Company has also signed a Letter of Agreement for an exclusive U. S.
license under certain patents to manufacture, market and distribute I-125
sputter coated seeds. Permanent implant brachytherapy is a relatively new
technique currently used for the treatment of prostate cancer.
The Company also intends, under an exclusive worldwide license, to complete
development of and to manufacture and market for use in diagnostic nuclear
medicine a high resolution medical imaging camera, key components of which are
patented. Based on spatial resolutions achieved in industrial applications of
the licensed patented inventions, the Company believes its medical imaging
camera will have resolution at least four times greater than any medical imaging
camera currently on the market.
RESULTS OF OPERATIONS
Three Months ended March 31, 1998 and 1997
The Company's net loss for the quarter ending March 31, 1998 was $588,033 as
compared to $833,064 for the quarter ended March 31, 1997. Net loss per basic
common share totaled $.09 for the first quarter of 1998 as compared with $.21
for the comparable period in 1997. The decrease in the loss was partially due to
the receipt of development income related to the Company's contract with Imagyn
for brachytherapy seeds and partially to the capitalization of internal labor
costs as the Company concentrates its efforts on the construction of the isotope
production accelerators as well as radiochemistry and radiopharmaceutical
facilities.
<PAGE>
Revenues for the quarter ended March 31, 1998 were $150,000 as compared to
$128,072 for the comparable period in 1997. Gross profits for the quarter ending
March 31, 1998 were $87,170 as compared to $62,416 for the same period in 1997.
The increase in revenues was attributable to the development contract between
the Company and its marketing partner related to the development of
brachytherapy devices for the treatment of cancer. The contract, executed in
January 1998, calls for an additional $850,000 to be paid during the remainder
of 1998.
Operating expenses remained relatively constant at $814,077 for the three months
ended March 31, 1998 compared to $812,587 in the comparable period in 1997.
General and administrative, and sales and marketing expenses totaled $480,136
for the first quarter of 1998 as compared to $63,422 in the first quarter of
1997, an increase of $416,714. The increases in costs are attributable to the
increases in staffing for production, marketing, quality assistance, safety and
administrative personnel as the Company expands its organizational structure
prior to beginning operations. The majority of key management personnel were in
place prior to the beginning of the first quarter of 1998, therefore the Company
incurred $0 expense related to employee incentives as compared to $556,875 in
the first quarter of 1997, during which time the Company was granting incentives
to attract key officers.
Interest income earned during the first quarter of 1998 was $159,206 as compared
to $423 for the comparable period in 1997. This increase was attributable to the
investment of funds received from the Initial Public Offering completed in
August 1997. The Company capitalized all interest costs incurred on debt for the
first quarter of 1998 as compared to $83,316 recognized as interest expense for
the first quarter of 1997.
Liquidity and Capital Resources
From November 1, 1995 (inception) through May 1997, the Company obtained funds
primarily through principal shareholder guaranteed bank loans, sales of
accelerator components and excess equipment, sales of Common Stock in a private
placement to investors and from loans from stockholders and directors. During
the third quarter of 1997, the Company completed an underwritten public offering
of 2,200,000 shares of common stock , generating $16,907,706 in net proceeds to
the Company after commissions and legal, audit, printing and other expenses.
Approximately $3,200,000 of funds from the public offering were utilized to
extinguish all Company debt outstanding at the time of the offering, with the
exception of the construction loan for the Company's administration,
manufacturing, research and development facility. Additional funds of $801,133,
net of underwriters' discount, were received by the Company in September 1997.
Disbursements of approximately $4,425,089 were expended for the purposes of
engineering, design and the purchase and installation of machinery, equipment
and capital assets. Funds in the amount of $1,194,044 were utilized for working
capital purposes, including personnel, facilities, insurance and other operating
expenses. These transactions resulted in remaining cash, cash equivalents and
short-term securities of approximately $8,800,000 at the end of the first
quarter. The majority of the funds are invested in short-term instruments with
maturity dates of six months or less.
The Company has experienced several changes to its financial ratios during the
past year. Current assets to current liability ratios at March 31, 1998 were 5.5
to 1 as compared to the current asset to current liability ratio of 1.2 to 1 for
the corresponding period ending March 31, 1997. The total asset to total
liability ratios for the corresponding periods were 3.7 to 1 and 1 to 1.06,
respectively. Shareholder equity increased to $15,337,607 from a deficit of
$200,303.
Management is currently negotiating potential financing from financial
institutions and commercial lenders for the construction of facilities currently
underway and increased installation and construction of facilities for the
production of finished radiopharmaceuticals to respond to additional demands
from potential customers. Management anticipates, based on its currently
proposed plans and assumptions relating to its operations, that the current cash
resources, proposed financing, income from operations, sale of assets held for
sale and sale of inventory will be sufficient to sustain operations for at least
the next 12 months.
<PAGE>
PART II. OTHER INFORMATION
Item 5. Other Information
During January 1998, the Company entered into a contract with Imagyn Medical
Technologies for development and manufacturing of radioisotope permanent implant
seeds for the treatment of cancer and other diseases, a process known as
brachytherapy. The contract includes a $1,000,000 development fee to be paid to
the Company and provides for an exclusive exclusive three year supply contract
with expected purchases by Imagyn anticipated to generate revenues for I(3) of
approximately $9,000,000 over the life of the contract. The $1,000,000
development fee will be recognized as the Company successfully completes a
series of milestones. The initial payment of $150,000 received during the first
quarter of 1998, was awarded to I3 after inspection and approval by Imagyn,
On March 4, 1998 the Company purchased from the State of Texas 115 acres of land
and a 30,000 square foot building in Waxahachie, Texas, the former site of the
SSC, for $400,000. The Company financed the purchase through a $320,000, 15-year
prime rate note with Citizens National Bank of Waxahachie. The property will be
used as a secondary accelerator production and testing site.
The first meeting of the Company's Science and Technology Advisory Board was
held at the Company's headquarters in Denton, Texas on March 23, 1998. The
Science and Technology Advisory Board's charter calls for it to perform a
critical and constructive review of the Company's progress, goals, objectives
and performance and to advise the Company on long-range strategy and emerging
potential new products. Members of the Board include the following: Dr. Norman
Hackerman, Chairman, President Emeritus, Rice University, Houston, Texas; Dr.
Frederick Bonte, M.D., Associate Chairman, Director of Nuclear Medicine
Technology, University of Texas Southwestern Medical Center, Dallas, TX; Dr.
Edward Knapp, Ph.D., Associate Chairman of Accelerator Technology, formerly of
Los Alamos National Laboratory and Santa Fe Institute, Santa Fe, NM; Dr. Richard
Reba, M.D., University of Chicago, Chicago, IL; Dr. Paul Murphy, Ph.D.,Baylor
College of Medicine, Houston, TX; Dr. Michael Devous, Ph.D., University of Texas
Southwestern Medical Center, Dallas, TX; Dr. Henry Kramer, Ph.D., industry
consultant, Moraga, CA; Dr. Tom Tombrello, Ph.D., California Institute of
Technology, Pasadena, CA; Dr. Earnest Gloyna, Ph.D., University of Texas at
Austin; Dr. Jerry Watson, Ph.D., International Isotopes Inc., Denton, TX; Mr.
Rudy Damm, Argonne National Laboratory; Dr. Robert Jameson, Ph.D., Los Alamos
National Laboratory; and Dr. Frank Masse, Ph.D., MIT, Cambridge, MA.
On April 24, 1998, Company completed the acquisition of MAC Isotopes, Inc. from
its parent corporation, MACTEC, Inc., of Golden Colorado and then merged MAC
Isotopes into International Isotopes Idaho Inc, a newly formed subsidiary of the
Company. The Company exchanged 159,416 shares of its unregistered Common Stock,
valued at $3,173,973 for 100% of the stock in MAC Isotopes. Upon consummation of
the acquisition, the Company also loaned $500,000 to MAC Isotopes, Inc. to
pay liabilities owed to MACTEC, Inc. International Isotopes Idaho Inc,
incorporated in Texas (formerly MAC Isotopes, Inc.), assumed MAC Isotopes'
exclusive five year long-term contract, with an option to renew for three
additional years, for the utilization of the Department of Energy Advanced Test
Reactor facility located near Idaho Falls, Idaho. Activities conducted at this
location include the production of high specific activity medical radioisotopes
to be used in diagnostics and therapy of cancer and various diseases.
<PAGE>
Item 6. Exhibits and Reports on Form 8 - K
Exhibits:
2.1 Agreement and Plan of Merger dated April 24, 1998 by and among The
Company, I(3) Acquisition Sub. Inc., MACTEC, Inc. and MAC Isotopes,
Inc. (incorporated by reference to Exhibit 2.1 of the Company's
Form 8-K filed May 8, 1998).
3.1 Restated Articles of Incorporation of the Company (incorporated by
reference to Exhibit 3.1 to the Company's Registration Statement
on Form SB-2 (Registration No. 333-29629)).
3.2 Bylaws of the Company (incorporated by reference to Exhibit 3.2 to
the Company's Registration Statement on Form SB-2 (Registration
No. 333-26269)).
4.1 Contract dated February 5,1998 between the Company and MSS Clean
Technology in the amount of $2,014,793 for the construction of
pharmaceutical processing modular rooms.
27.1 Financial Data Schedule
Reports on Form 8-K:
The Company filed a Form 8-K on May 8, 1998 with respect to the acquisition of
MAC Isotopes, Inc.
I(3) International Isotopes Inc.
Section A Contract Form and Signature Page
- --------------------------------------------------------------------------------
Contract Number: PM-801
Mod Number: Orig
Date: 2/06/98
- --------------------------------------------------------------------------------
To: MSS Clean Technology, Inc. From: International Isotopes Inc.
3100 Smoketree Court, Suite 610 3100 Jim Christal Road
Raleigh, NC 27604 Denton, TX 76207
This definitive contract is made and entered into by and between International
Isotopes Inc., address above, a Texas corporation, (hereinafter referred to as
I(3), or "Buyer" and MSS Clean Technology Inc., a Delaware corporation, address
above, hereinafter referred to as MSS, or "Seller".
Whereas, International Isotopes Inc. is in the business of supplying equipment,
services, pharmaceuticals, and components to the drug industry. International
Isotopes Inc. desires to obtain the services of Seller related to fabrication
and installation of clean room facilities, and Seller is willing to provide such
services. Accordingly, the parties have agreed as follows:
The Seller has represented to the Buyer that it has the capability and capacity
without any additional Buyer furnished facilities to perform all of the work
hereunder in accordance with the terms of the order, except as noted herein.
Buyer and Seller have negotiated and mutually agreed upon the Contract
requirements and deliveries, established a price arrangement, and other terms
and conditions as contained herein.
The Seller acceptance of this subcontract will be indicated by affixing its
authorized signature to two (2) originals of this Contract and returning one
executed original to I(3) no later than: February 6th, 1998.
ARTICLE A-1: INCLUSIVE SECTIONS
A-1
<PAGE>
Section A Contract Form and Content
ARTICLE A-1: INCLUSIVE SECTIONS
Documents comprising this Contract are as follows:
<TABLE>
<CAPTION>
Document Title
- -------- -----
<S> <C>
Section A Contract Form and Content
Section B Schedule of Supplies, Services, and Pricing
Section C Statement of Work and Quality Assurance Requirements
Section D Packaging, Marking, and Transportation
Section E Qualification and Acceptance Provisions
Section F Delivery and Performance Schedules
Section G Administrative Data
Section H Special Contract Requirements and Provisions
Section I General Contract Requirements and Provisions
Section J List of Documents, Exhibits, and other Attachments
Section K Representations and Certifications
</TABLE>
ARTICLE A-2: TERMS AND CONDITIONS
The Buyer and Seller have mutually agreed upon the Contract requirements and
established a firm fixed price for items and services listed in Section B. The
terms and conditions shall be as listed in the specific sections listed above.
ARTICLE A-3: PERIOD OF PERFORMANCE
The Period of Performance (POP) of this Contract shall be from December 5th,
1997 through May 31st, 1998. The period of performance specifically includes
the design phase which was initiated by Buyer's letter of intent dated December
5th, 1997 and authorized by Buyer's letter dated December 9th, 1997.
A-2
<PAGE>
Section B Schedule of Supplies, Services, and Pricing
ARTICLE B-1: DELIVERABLES
The following deliverable contract line items are herein established for this
Contract:
<TABLE>
Line Description Qty Unit Price Extended
Item Price
<S> <C> <C> <C> <C>
1 Design Package Development $100,000 $100,000
2 Envelope System
3 HVAC System
4 Electrical System
5 Plumbing and Piping System
6 Steelwork System
7 Miscellaneous Items
8 Specialty Services
NOTE: Line Items 2 through 8 are
Not Separately Priced
Total $1,995,789
Add-on tasks per quote dated January 28th $19,003
Revised Total Fixed Price $2,014,792
</TABLE>
The above table lists the general category of facilities and services to be
provided under this contract. The detailed items and services to be supplied are
listed in the MSS proposal 10694/Q5737, dated January 6th, 1998, incorporated
herein by reference. The items and services are further described in work
statements, specifications, and drawings which are incorporated into this
contract by reference in Section C and Section J.
ARTICLE B-2: COST/PRICE
B.2.1 FIRM FIXED PRICE
The Firm Fixed Price for all facilities, goods, and services to be
supplied under this contract is $2,014,792. All prices are in U.S. dollars. This
total price includes all efforts authorized and performed under pre-contract
letter authorizations issued by Buyer on December 5th, and December 9th, 1997,
and on January 13th, 1998.
B.2.2 FIXED PRICE OPTIONS--not applicable to this Contract.
B.2.3 UNPRICED OPTIONS--not applicable to this Contract.
B-3
<PAGE>
Section B Schedule of Supplies, Services, and Pricing
ARTICLE B-3: PROGRESS AND MILESTONE PAYMENTS
Progress and/or Milestone payments will be made net 30 days from receipt of
properly executed invoice at the address specified below.
International Isotopes Inc.
3100 Jim Christal Road
Denton, TX 76201
Attn: Accounts Payable, Ms J. Gillett
B.3.1 PROGRESS PAYMENTS--not applicable to this contract.
B.3.2 MILESTONE PAYMENTS
The following billing milestones are applicable to this contract:
<TABLE>
<CAPTION>
- ------------------------------ --------------------- ------------- ----------------------
Event Projected Date Event Amount
- ------------------------------ --------------------- ------------- ----------------------
<S> <C> <C> <C>
Initial Authorization 12/9/97 $50,000
- ------------------------------ --------------------- ------------- ----------------------
Award and Design Approval 1/30/98 $50,000
- ------------------------------ --------------------- ------------- ----------------------
MSS On-Site 2/9/98 $425,000
- ------------------------------ --------------------- ------------- ----------------------
MSS On-Site 4 wks 3/9/98 Note 1 $425,000
- ------------------------------ --------------------- ------------- ----------------------
MSS On-Site 8 wks 4/6/98 Note 1 $425,000
- ------------------------------ --------------------- ------------- ----------------------
Satisfactory Completion 4/27/98 $519,003
- ------------------------------ --------------------- ------------- ----------------------
Final Certifications 6/1/98 $120,789
- ------------------------------ --------------------- ------------- ----------------------
- ------------------------------ --------------------- ------------- ----------------------
Total $2,014,792
- ------------------------------ --------------------- ------------- ----------------------
</TABLE>
Payment of the above billing milestones are based on satisfactory progress
toward completion of the clean room facilities. If, in the sole opinion of
Buyer, satisfactory progress is not being made, formal notice will be given to
Seller as to the amount of payment being withheld, and the expected corrective
action(s) necessary to cure the deficiency and obtain release of withheld
payment.
Note 1: Payment event for these payments will be derived from the detailed
construction schedule available not later than February 15th, 1998. Buyer and
Seller shall mutually agree on schedule event(s) which comprise basis for
payment.
B-4
<PAGE>
Section C Statement of Work and Quality Assurance Requirements
Statement of Work (SOW)
MSS is to perform all design, fabrication, installation and testing of the clean
room complex as described in the proposal dated January 6th, 1998, and all
related specifications and drawings. The clean room complex includes:
Envelop system
Clean Room Classified Areas
Non-Classified Areas
HVAC System
Electrical System
Plumbing and Piping System
Steelwork System
Miscellaneous and Specialty Equipment and Tasks, including:
HVAC and Power Test & Balance
Cleanroom Certification
Engineering design and drawing development
On-site Installation and Supervision
Project Management
The work shall be performed in accordance with Attachment A to this contract,
the MSS Scope of Work & Technical Specification For Cleanroom and Ancillary Area
Construction fax dated January 14th, 1998. All materials shall conform to the
specifications contained in that design package.
C-5
<PAGE>
Section D Packaging, Marking, and Transportation
MSS is responsible for the safe packaging, transportation, and delivery of the
clean room components from MSS facilities to I(3) Denton, Texas facilities at
3100 Jim Christal Road.
D-6
<PAGE>
Section E Qualification and Acceptance Provisions
Acceptance shall be at I(3) Denton, Texas facilities. Acceptance inspection and
testing shall be performed in accordance with the I(3) approved test plan and
inspection procedures.
Clean Room Certification (MSS document 15191, revised by I(3) and applied as
attachment B to this Contract) will be used as basis for the detailed acceptance
test plan.
E-7
<PAGE>
Section F Delivery and Performance Schedules
The following scheduled milestones must be met in the performance of this
contract:
<TABLE>
<CAPTION>
- ------------------------------ --------------------- ------------- ----------------------
Event Projected Date Item Completion
- ------------------------------ --------------------- ------------- ----------------------
<S> <C> <C>
Award and Design Approval 1/30/98 Contract Signature
- ------------------------------ --------------------- ------------- ----------------------
MSS On-Site 2/9/98 Team/Subs in Denton
- ------------------------------ --------------------- ------------- ----------------------
MSS On-Site 4 wks 3/9/98 See B 3.2
- ------------------------------ --------------------- ------------- ----------------------
MSS On-Site 8 wks 4/6/98 See B 3.2
- ------------------------------ --------------------- ------------- ----------------------
Satisfactory Completion 4/27/98 Successful Walk thru
- ------------------------------ --------------------- ------------- ----------------------
Final Certifications 6/1/98 All Certifications
- ------------------------------ --------------------- ------------- ----------------------
</TABLE>
F-8
<PAGE>
Section G Administrative Data
ARTICLE G-1: NOTICES
Formal notices under this Contract given by either party to the other shall be
in writing and transmitted via fax, followed by signed copy sent by U.S. Postal
Service, Certified Mail, Return Receipt Requested (or equivalent premium package
service) addressed as follows:
<TABLE>
<CAPTION>
SELLER INTERNATIONAL ISOTOPES INC.
<S> <C>
MSS Clean Technology International Isotopes Inc.
3100 Smoketree Court, Suite 910 3100 Jim Christal Road
Raleigh, NC 27604 Denton, TX 76207
Attn: James Kavanaugh Attn: Glenn Vickery
ARTICLE 2: POINTS OF CONTACT
The following points of contact are designated for this contract:
Technical Issues:
SELLER INTERNATIONAL ISOTOPES INC.
Bill Lynch Bob Wetsel
MSS Clean Technology International Isotopes Inc.
3100 Smoketree Court, Suite 910 3100 Jim Christal Road
Raleigh, NC 27604 Denton, TX 76207
Phone: 919-876-8577 Phone: 940-484-9492
Fax: 919-876-9633 Fax: 940-484-0877
Contract Issues:
SELLER INTERNATIONAL ISOTOPES INC.
James Kavanaugh Glenn Vickery
MSS Clean Technology International Isotopes Inc.
3100 Smoketree Court, Suite 910 3100 Jim Christal Road
Raleigh, NC 27604 Denton, TX 76207
Phone: 919-876-8577 Phone: 940-484-9492
Fax: 919-876-9633 Fax: 940-484-0877
</TABLE>
G-9
<PAGE>
Section H Special Contract Requirements and Provisions
ARTICLE H-1: ORDER OF PRECEDENCE
In the event of any inconsistency or conflict between or among the sections of
this contract, the following order of precedence shall be used to resolve the
conflict:
(1) This contract, specifically Articles A and B
(2) The Specifications and Drawings, as defined in Section J.
(3) The Statement of Work, as defined in Section C.
ARTICLE H-2: CHANGES AND WRITTEN AUTHORIZATION
Changes, extensions, or other modifications to this Contract may be made at any
time during the period of performance hereof. Changes affecting scope of work,
delivery schedule, or price shall require written consent of the parties hereto.
Changes to this Contract will be executed only by individual(s) authorized by
I(3) to make such changes. Changes will take the form of a fully executed
modification to this Contract. All risk of executing any changes not authorized
in writing by I(3) rests with the Seller.
ARTICLE H-3: BUYER FURNISHED FACILITIES, EQUIPMENT, AND DATA
The following items of facilities, equipment, material, and data shall be
supplied by I(3) to the Seller for use in the performance of work under this
subcontract:
Buyer will provide Seller with access to facilities at 3100 Jim Christal Road,
Denton, TX for the purpose of erecting Clean Room and supporting facility
improvements. Facility support will be provided by I(3) as listed in
EXCLUSIONS/CLARIFICATIONS section of the MSS proposal dated January 6th, 1998,
except for items 1, 2, 4, and 5, which were incorporated into this contract from
Seller's quote dated January 28th, 1998.
If items are supplied by I(3) but not consumed in the performance of work under
this Contract, they shall be returned at the end of performance in usable
condition, normal wear and tear excepted, freight prepaid. Data supplied by I(3)
shall be packaged for protection and returned to I(3) via First Class Mail at
the completion of performance.
ARTICLE H-4: WARRANTY
MSS shall provide a One-year parts, materials, and installation warranty on all
clean room elements and components provided by or installed under the
supervision of MSS. Warranty items supplied by MSS which do not pass FDA
validation must be corrected within 15 days of notice from I(3).
H-10
<PAGE>
Section H Special Contract Requirements and Provisions
ARTICLE H-5: PROPRIETARY DATA
In the event either buyer or seller is required or finds it necessary to provide
company private or proprietary data to the other party during the performance of
this Contract, Buyer and Seller agree to afford such data with the protection
necessary to preclude its inadvertent disclosure to unauthorized parties. Such
data must be destroyed or returned to originator upon request. Should
destruction be requested, the party in possession of the data shall certify its
destruction by letter to the party who originated the data.
ARTICLE H-6: DISPUTES
In the event of a dispute arising between the parties during the performance of
this Contract, such dispute shall be resolved through arbitration as defined:
Arbitration
(a) As concluded by the parties to this Contract on the advise of their
counsel, and as evidenced by the signatures of the parties hereto, it is agreed
that all questions as to rights and obligations arising over the terms of this
Contract are subject to arbitration except disputes in which less than $50,000
is in controversy, and such arbitration shall be governed by the provisions of
the Texas General Arbitration Act.
(b) If a dispute should arise under this Contract, either party may
within 30 days after the date on which such dispute arises make a demand for
arbitration by filing a demand in writing with the other. The parties to this
Contract may agree on one arbitrator, but in the event that they cannot do so
there shall be three arbitrators, one named in writing by each of the parties
within 60 days after demand for arbitration is made, and a third to be chosen by
the two so named. Should either party fail to timely join in the appointment of
the arbitrators, the arbitrators shall be appointed in accordance with the
provisions of Texas Civil Practice and Remedies Code, Section 171.003.
(c) All arbitration hearings conducted under the terms of this Contract,
and all judicial proceedings to enforce any of the provisions of this Contract,
shall take place in Denton County, Texas.
(d) If there is only one arbitrator, his or her decision shall be
binding and conclusive on the parties. If there are three arbitrators, the
decision of any two shall be binding and conclusive. The submission of a dispute
to the arbitrators and the rendering of their decision shall be a conditions
precedent to any right of legal action on the dispute.
(e) The cost and expenses for arbitrators, including the fees of the
arbitrators, shall be borne by the losing party or in such proportions as the
arbitrators shall determine.
H-11
<PAGE>
Section H Special Contract Requirements and Provisions
ARTICLE H-7: TERMINATION
This contract may be terminated, under any of the following circumstances, by
Buyer by giving 30 days formal notice to Seller.
a. Termination for Default; For any material breach by Seller; the
Default provisions in H-8 below shall apply.
b. Termination for Convenience of Buyer; Buyer to pay actual and
reasonable costs through date of termination; fee settlement will be
negotiated between Buyer and Seller.
c. Completion of the Contract; a properly executed Release of Claims may
be required by Buyer.
termination.
ARTICLE H-8: DEFAULT BY SELLER AND REMEDIES
The following shall constitute events of default by Seller pursuant to this
Contract:
a. Seller fails to comply with any covenant, condition, requirement or
obligation required of Seller hereunder and such failure is not cured within 5
days after written notice of such failure is provided to Seller by Buyer;
b. Seller makes an assignment of Seller's business for the benefit of creditors;
c. A petition of bankruptcy is filed by or against Seller;
d. A receiver, trustee in bankruptcy, or similar officer is appointed to take
control of all or part of Seller's property; or
e. Seller is adjudicated a bankrupt.
In the event of such default International Isotopes may terminate this agreement
and sue for damages or pursue any other remedy available to it at law or in
equity.
ARTICLE H-9: LIQUIDATED DAMAGES--not used.
H-12
<PAGE>
Section I General Contract Requirements and Provisions
ARTICLE I-1: GOVERNING LAW AND FORM
This Contract shall in all respects be interpreted, construed, and governed by
and in accordance with the laws of the State of Texas, disregarding any conflict
of law provisions which may require the application of the law of another
jurisdiction. Any action to enforce, or which arises out of or in any way
relates to, any of the provisions of this Contract shall be brought and
prosecuted in such court or courts located within the State of Texas as provided
by law; and the parties consent to the jurisdiction of said court or courts
located within the State of Texas, and to service or process by registered mail,
return receipt requested, or by any other manner provided by the law of the
State of Texas.
ARTICLE I-2: CONFIDENTIALITY AGREEMENT
Sellers performing work for I(3) are required to sign the company's
Confidentiality Agreement, which is attached hereto and incorporated into this
Contract by this reference.
ARTICLE I-3: PUBLICITY Neither party to this Contract may use the name of the
other in news releases, publicity, advertising, or product/service promotions
without the prior written consent of the other. I(3) reserves the right to
review and approve the content of any publicity materials prepared for release
by the Seller wherein that material refers to I(3) or the work covered by this
Contract.
ARTICLE I-4: COUNTERPARTS
This Contact may be executed simultaneously in two or more counterparts, each of
which shall be deemed an original, but all of which together shall constitute
and be the same instrument. All schedules, exhibits and documents referred to
Article A-1 hereof, are incorporated herein and expressly made a part of this
Contract as though completely set forth herein. All references to this Contract
herein or in any of the schedules, exhibits or documents referred to in Article
A-1 and attached hereto shall be deemed to refer to this entire Contract,
including all schedules, exhibits and attachments.
ARTICLE I-5: INDEMNIFICATION
Seller shall defend, indemnify and hold harmless Buyer and its directors,
shareholders, officers, employees, agents, consultants, representatives,
affiliates, successors and assigns from and against any and all claims,
liabilities, obligations, losses, costs, expenses (including without limitation,
reasonable legal expenses), litigation, proceedings, fines, taxes, levies,
duties, deficiencies, assessments, charges, penalties, allegations, demands,
damages (including by not limited to actual, punitive or consequential, foreseen
or unforeseen, known or unknown, fixed or contingent, and matured or unmatured),
civil and criminal violations of law, settlements and judgments of any kind or
nature whatsoever, which may incur or arise out of the performance of Seller's
duties and obligations hereunder.
I-13
<PAGE>
Section I General Contract Requirements and Provisions
ARTICLE I-6: ASSIGNABILITY
This Contract shall not be assignable by either party without the express
written consent of the other except for assignments to subsidiaries or
affiliates of the parties hereto, provided that such assignment or assignments
shall not relieve the assigning party of any obligation or liability under this
Contract.
ARTICLE I-7: HEADINGS
The headings and subheadings hereof are inserted for the convenience of
reference only and shall not affect the interpretation of this Contract.
ARTICLE I-8: BINDING EFFECT
This Contract shall be binding upon, inure to the benefit of, and be enforceable
by the successors and permitted assigns to the parties hereto.
ARTICLE I-9: WAIVERS
Any waiver of rights hereunder must be set forth in writing. A waiver of any
breach or failure to enforce any of the terms or conditions of this Contract
shall not in any way affect, limit or waive either party's rights at any time to
enforce strict compliance thereafter with every term or condition of this
Agreement.
ARTICLE I-10: SEVERABILITY
If and to the extent that any court of competent jurisdiction holds any
provisions, or any part thereof, of this Contract to be invalid or enforceable,
such holdings shall in no way affect the validity of the remainder of this
Contract.
ARTICLE I-11: ENTIRE AGREEMENT
This Contract constitutes the entire agreement of the parties with respect to
the subject matter hereto and supersedes all previous agreements, understandings
or discussions with respect to the subject matter hereof.
I-14
<PAGE>
Section J List of Documents, Exhibits, and other Attachments
The following table of drawings (issue in effect at time of award unless changed
below) shall define the facility to be designed, built, installed, and delivered
under this contract:
For plumbing and electrical requirements, the provisions of the Conceptual
Design Summary shall apply until the formal drawings are received and approved
by Buyer.
<TABLE>
<CAPTION>
- ----------------------------------------------------------------------------------
Sheet Title Date Rev
- ----------------- ---------------------------------- -------------- --------------
<S> <C> <C> <C>
M-1 Symbols & Abbreviations 1/14/98
- ----------------- ---------------------------------- -------------- --------------
M-2 Flow Schematic 1/14/98
- ----------------- ---------------------------------- -------------- --------------
M-3 Flow Schematic 1/14/98
- ----------------- ---------------------------------- -------------- --------------
M-4 Equipment Schedules 1/14/98
- ----------------- ---------------------------------- -------------- --------------
M-5 Make Up Air Duct Plan 1/14/98
- ----------------- ---------------------------------- -------------- --------------
M-6 Recirc Ductwork Plan 1/14/98
- ----------------- ---------------------------------- -------------- --------------
M-7 Exhaust Ductwork Plan 1/14/98
- ----------------- ---------------------------------- -------------- --------------
M-8 HVAC Piping Plan 1/14/98
- ----------------- ---------------------------------- -------------- --------------
M-9 Mechanical Sections To Be
Produced
- ----------------- ---------------------------------- -------------- --------------
M-10 Mechanical Sections To Be
Produced
- ----------------- ---------------------------------- -------------- --------------
M-11 Mechanical Details 1/14/98
- ----------------- ---------------------------------- -------------- --------------
M-12 Mechanical Details 1/14/98
- ----------------- ---------------------------------- -------------- --------------
P-1 Process Piping Plan TBP
- ----------------- ---------------------------------- -------------- --------------
P-2 Drain Systems Plan TPB
- ----------------- ---------------------------------- -------------- --------------
P-3 Plumbing Details TBP
- ----------------- ---------------------------------- -------------- --------------
P-4 Plumbing Details TBP
- ----------------- ---------------------------------- -------------- --------------
P-5 Plumbing Details TBP
- ----------------- ---------------------------------- -------------- --------------
E-1 One Line Diagram 1/14/98
- ----------------- ---------------------------------- -------------- --------------
E-2 Electrical Floor Plan TBP
- ----------------- ---------------------------------- -------------- --------------
E-3 Lighting Plan TBP
- ----------------- ---------------------------------- -------------- --------------
E-4 Power Plan TBP
- ----------------- ---------------------------------- -------------- --------------
E-5 Electrical Details TBP
- ----------------- ---------------------------------- -------------- --------------
E-6 Panel Schedules TBP
- ----------------------------------------------------------------------------------
</TABLE>
J-15
<PAGE>
Section J List of Documents, Exhibits, and other Attachments
<TABLE>
<CAPTION>
- ----------------------------------------------------------------------------------
Sheet Title Date Rev
- ----------------- ---------------------------------- -------------- --------------
<S> <C> <C> <C>
5737-0601 Cleanroom Ceiling Interface 1/8/98
Detail
- ----------------- ---------------------------------- -------------- --------------
5737-0602 Ancillary Area Ceiling Interface 1/8/98
Detail
- ----------------- ---------------------------------- -------------- --------------
5737-0603 Cleanroom Flooring Interface 1/13/98
Detail
- ----------------- ---------------------------------- -------------- --------------
5737-0604 Ancillary Area Flooring 1/13/98
Interface Detail
- ----------------- ---------------------------------- -------------- --------------
7384-98 Steel Systems Mezzanine 1/13/98
- ----------------- ---------------------------------- -------------- --------------
</TABLE>
M-4, Equipment Schedules, provides the list and specifications of major
equipment items.
J-16
<PAGE>
Section J List of Documents, Exhibits, and other Attachments
This West Building Conceptual Design Summary provides a summary of the facility
design requirements/specifications which must be met:
<TABLE>
<CAPTION>
- --------- -------------------------- ------------- -------------- ------- -------- ---------- --------- -------
Room No. Room Name Cleanroom Dimensions Area Temp Humidity Velocity ACPH
Classification (LxWxH) SqFt F +/- %RH +/- FPM
- --------- -------------------------- ------------- -------------- ------- -------- ---------- --------- -------
<S> <C> <C> <C> <C> <C> <C> <C> <C>
1 Process Materials Storage N/A 12x11x8 132 70 +/-2 <60 10
- --------- -------------------------- ------------- -------------- ------- -------- ---------- --------- -------
2 Airlock #1 100,000 12x11x8 132 70 +/-2 <60 20
- --------- -------------------------- ------------- -------------- ------- -------- ---------- --------- -------
3 RadioPharm Lab #1 10,000 12x15x9 180 70 +/-2 <60 60
- --------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
4 RadioPharm Lab #2 10,000 12x15x9 180 70 +/-2 <60 30
- --------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
5 RadioPharm Lab #3 10,000 12x15x9 180 70 +/-2 <60 30
- --------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
6 RadioPharm Lab #4 10,000 12x15x9 180 70 +/-2 <60 60
- --------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
7 RadioPharm Lab #5 10,000 12x15x9 180 70 +/-2 <60 30
- --------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
8 RadioPharm Lab #6 10,000 12x15x9 180 70 +/-2 <60 30
- --------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
9 Hallway 10,000 12x5.5x9 66 70 +/-2 <60 30
- --------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
10 Airlock #2 100,000 24x5.5x9 132 70 +/-2 <60 20
- --------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
11 Autoclave & Storage N/A 16x20.5x8 328 70 +/-2 <60 10
- --------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
12 Assay N/A 16x15x8 240 70 +/-2 <60 10
- --------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
13 Lead Pig Storage N/A 11x10x8 110 70 +/-2 <60 10
- --------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
14 Radiological Control Area N/A 11x10x8 110 70 +/-2 <60 10
- --------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
15 Hallway N/A 271x6.5x8 1762 70 +/-2 <60 10
- --------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
16 QC Analytical Lab N/A 355.5 70 +/-2 <60 10
- --------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
17 Pre Package 1 N/A 12x15x8 180 70 +/-2 <60 10
- --------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
18 Vial Fill #1 1,000 12x18x8 216 70 +/-2 <60 40
- --------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
19 Airlock 100K 100,000 45 70 +/-2 <60 20
- --------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
20 Airlock 10K 10,000 70 +/-2 <60 30
- --------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
21 Vial Fill #2 1,000 12x18x8 216 70 +/-2 <60 40
- --------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
22 Cold Chemistry 100,000 278.5 70 +/-2 <60 10
- --------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
23 Pre Package 2 N/A 12x18x8 216 70 +/-2 <60 10
- --------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
24 Airlock 100K 100,000 7.5x6x8 45 70 +/-2 <60 20
- --------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
25 Airlock 10K 10,000 7.5x6x8 45 70 +/-2 <60 30
- --------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
26 Airlock 1K 1,000 8x8x8 64 70 +/-2 <60 40
- --------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
27 Aseptic Vials Receiving 100 16x8x8 128 70 +/-2 <60 90+/-18 60
- --------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
28 Records N/A 16x10x8 160 70 +/-2 <60 10
- --------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
29 QC Radiometric N/A 16x10x8 160 70 +/-2 <60 10
- --------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
30 Radio Assay N/A 16x10x8 160 70 +/-2 <60 10
- --------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
31 Glass Washing Vial N/A 483.5 70 +/-2 <60 10
- --------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
32 Quarantine N/A 12x7x8 84 70 +/-2 <60 10
- --------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
33 Label Storage N/A 12x7x8 84 70 +/-2 <60 10
- --------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
34 Stability N/A 16x9x8 144 70 +/-2 <60 10
- --------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
35 HP Lab N/A 16x9x8 144 70 +/-2 <60 10
- --------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
36 Label Room N/A 16x9x8 144 70 +/-2 <60 10
- --------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
37 Radiological Control Area N/A 9x9x8 81 70 +/-2 <60 10
- --------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
38 Frisk Room N/A 5x8x8 40 70 +/-2 <60 10
- --------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
39 Men's Lockers N/A 198 70 +/-2 <60 10
- --------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
40 Men's Sinks N/A 112 70 +/-2 <60 10
- --------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
41 Men's Toilets N/A 115 70 +/-2 <60 10
- --------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
42 Rad Gowning N/A 13.5x11x8 148.5 70 +/-2 <60 10
- --------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
43 cGMP Cleaning Materials N/A 5x8x8 40 70 +/-2 <60 10
- --------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
44 Women's Lockers N/A 198 70 +/-2 <60 10
- --------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
45 Women's Sinks N/A 104 70 +/-2 <60 10
- --------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
46 Women's Toilets N/A 109 70 +/-2 <60 10
- --------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
47 Airlock 100K 100,000 5x9x8 45 70 +/-2 <60 20
- --------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
48 Airlock 10K 10,000 5x9x8 45 70 +/-2 <60 30
- --------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
49 Sterility Lab 1,000 15x9x8 135 70 +/-2 <60 40
- --------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
50 Micro Prep N/A 25x9x8 225 70 +/-2 <60 10
- --------- -------------------------- ------------- -------------- ------- -------- ---------- --------- -------
9,032
- --------- -------------------------- ------------- -------------- ------- -------- ---------- --------- -------
</TABLE>
J-17
<PAGE>
Section J List of Documents, Exhibits, and other Attachments
<TABLE>
<CAPTION>
- --------- -------------------------- ------------- -------------- ------- -------- ---------- --------- -------
Room No. Room Name Cleanroom Dimensions Area Temp Humidity Velocity ACPH
Classification (LxWxH) SqFt F +/- %RH +/- FPM
- --------- -------------------------- ------------- -------------- ------- -------- ---------- --------- -------
<S> <C> <C> <C> <C> <C> <C> <C> <C>
51 Chemistry Records N/A 18x17x8 306 70 +/-2 <60 10
- --------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
52 Micro Lab N/A 15x9x8 135 70 +/-2 <60 10
- --------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
53 Incubator N/A 9x25x8 225 70 +/-2 <60 10
- --------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
54 QA Records N/A 18x27x8 486 70 +/-2 <60 10
- --------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
59 Hallway N/A 25x6.5x8 163 70 +/-2 <60 10
- --------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
60 Unpacking Room N/A 70 +/-2 <60 10
- --------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
61 Autoclave Tech Room N/A 70 +/-2 <60 10
- --------- -------------------------- ------------- -------------- ------- -------- ---------- --------- -------
Total - Rooms 51-54 1,446
- --------- -------------------------- ------------- -------------- ------- -------- ---------- --------- -------
Total - Rooms 1-50 9,032
- --------- -------------------------- ------------- -------------- ------- -------- ---------- --------- -------
Total Square Footage 10,478
- --------- -------------------------- ------------- -------------- ------- -------- ---------- --------- -------
</TABLE>
J-18
<PAGE>
Section J List of Documents, Exhibits, and other Attachments
<TABLE>
<CAPTION>
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
Room No. Room Name Number Light Diff. Exhaust Heat Gain Air Flow Supply
of People Level (FC) Pressure (CFM) (KW)
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
<S> <C> <C> <C> <C> <C> <C> <C> <C>
1 Process Materials Storage 0 75 RECIRC DUCTED
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
2 Airlock #1 1 75 OT DUCTED
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
3 RadioPharm Lab #1 1 75 1315 OT DUCTED
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
4 RadioPharm Lab #2 1 75 350 OT DUCTED
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
5 RadioPharm Lab #3 1 75 350 OT DUCTED
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
6 RadioPharm Lab #4 1 75 1315 OT DUCTED
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
7 RadioPharm Lab #5 1 75 350 OT DUCTED
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
8 RadioPharm Lab #6 1 75 350 OT DUCTED
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
9 Hallway 0 75 OT DUCTED
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
10 Airlock #2 1 75 RECIRC DUCTED
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
11 Autoclave & Storage 0 75 RECIRC DUCTED
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
12 Assay 3 75 RECIRC DUCTED
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
13 Lead Pig Storage 0 75 RECIRC DUCTED
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
14 Radiological Control Area 1 75 RECIRC DUCTED
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
15 Hallway 2 75 RECIRC DUCTED
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
16 QC Analytical Lab 1 75 965 RECIRC DUCTED
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
17 Pre Package 1 2 75 965 OT DUCTED
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
18 Vial Fill #1 1 75 350 OT DUCTED
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
19 Airlock 100K 1 75 RECIRC DUCTED
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
20 Airlock 10K 0 75 RECIRC DUCTED
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
21 Vial Fill #2 1 75 350 OT DUCTED
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
22 Cold Chemistry Lab 1 75 1930 RECIRC DUCTED
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
23 Pre Package 2 0 75 RECIRC DUCTED
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
24 Airlock 100K 1 75 RECIRC DUCTED
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
25 Airlock 10K 1 75 RECIRC DUCTED
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
26 Airlock 1K 1 75 RECIRC DUCTED
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
27 Aseptic Vials Receiving 1 75 RECIRC DUCTED
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
28 Records 1 75 RECIRC DUCTED
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
29 QC Radiometric 75 1930 RECIRC DUCTED
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
30 Radio Assay 1 75 RECIRC DUCTED
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
31 Glass Washing Vial 1 75 RECIRC DUCTED
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
32 Quarantine 0 75 RECIRC DUCTED
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
33 Label Storage 0 50 RECIRC DUCTED
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
34 Stability 0 50 RECIRC DUCTED
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
35 HP Lab 0 50 RECIRC DUCTED
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
36 Label Room 0 50 RECIRC DUCTED
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
37 Radiological Control Area 0 75 RECIRC DUCTED
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
38 Frisk Area 0 50 RECIRC DUCTED
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
39 Men's Lockers 3 50 RECIRC DUCTED
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
40 Men's Sinks 2 50 RECIRC DUCTED
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
41 Men's Toilets 2 50 RECIRC DUCTED
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
42 Rad Gowning 1 100 RECIRC DUCTED
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
43 cGMP Cleaning Materials 0 75 RECIRC DUCTED
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
44 Women's Lockers 3 75 RECIRC DUCTED
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
45 Women's Sinks 2 75 RECIRC DUCTED
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
46 Women's Toilets 2 75 RECIRC DUCTED
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
47 Airlock 100K 0 75 RECIRC DUCTED
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
48 Airlock 10K 0 75 RECIRC DUCTED
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
49 Sterility Lab 0 75 RECIRC DUCTED
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
50 Micro Prep 1 75 RECIRC DUCTED
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
</TABLE>
J-19
<PAGE>
Section J List of Documents, Exhibits, and other Attachments
<TABLE>
<CAPTION>
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
Room No. Room Name Number Light Diff. Exhaust Heat Gain Air Flow Supply
of People Level (FC) Pressure (CFM) (KW)
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
<S> <C> <C> <C> <C> <C> <C> <C> <C>
51 Chemistry Records 2 75 RECIRC DUCTED
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
52 Micro Lab 0 75 RECIRC DUCTED
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
53 Incubator 0 75 RECIRC DUCTED
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
54 QA Records 2 75 RECIRC DUCTED
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
59 Hallway 0 75 RECIRC DUCTED
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
60 Unpacking 0 75 RECIRC DUCTED
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
61 Autoclave Tech Room 0 75 RECIRC DUCTED
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
</TABLE>
J-20
<PAGE>
Section J List of Documents, Exhibits, and other Attachments
<TABLE>
<CAPTION>
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
Room No. Room Name Return HVAC Floor Wall Ceiling Fire Other
Type Zone Type Type Type Protect
<S> <C> <C> <C> <C> <C> <C> <C> <C>
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
1 Process Materials Storage DUCTED 1 Piece Smooth SUSP SPRNK
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
2 Airlock #1 DUCTED 1 Piece Smooth T-Grid SPRNK
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
3 RadioPharm Lab #1 DUCTED 1 Piece Smooth T-Grid SPRNK
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
4 RadioPharm Lab #2 DUCTED 1 Piece Smooth T-Grid SPRNK
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
5 RadioPharm Lab #3 DUCTED 1 Piece Smooth T-Grid SPRNK
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
6 RadioPharm Lab #4 DUCTED 1 Piece Smooth T-Grid SPRNK
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
7 RadioPharm Lab #5 DUCTED 1 Piece Smooth T-Grid SPRNK
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
8 RadioPharm Lab #6 DUCTED 1 Piece Smooth T-Grid SPRNK
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
9 Hallway DUCTED 1 Piece Smooth T-Grid SPRNK
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
10 Airlock #2 DUCTED 1 Piece Smooth SUSP SPRNK
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
11 Autoclave & Storage DUCTED 1 Piece Smooth SUSP SPRNK
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
12 Assay DUCTED 1 Piece Smooth SUSP SPRNK
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
13 Lead Pig Storage DUCTED 1 Piece Smooth SUSP SPRNK
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
14 Radiological Control Area DUCTED 1 Piece Smooth SUSP SPRNK
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
15 Hallway DUCTED 1 Piece Smooth SUSP SPRNK
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
16 QC Analytical Lab DUCTED 1 Piece Smooth SUSP SPRNK
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
17 Pre Package 1 DUCTED 1 Piece Smooth T-Grid SPRNK
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
18 Vial Fill #1 DBWALL 1 Piece Smooth T-Grid SPRNK
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
19 Airlock 100K DUCTED 1 Piece Smooth SUSP SPRNK
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
20 Airlock 10K DUCTED 1 Piece Smooth SUSP SPRNK
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
21 Vial Fill #2 DBWALL 1 Piece Smooth T-Grid SPRNK
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
22 Cold Chemistry Lab DUCTED 1 Piece Smooth T-Grid SPRNK
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
23 Pre Package 2 DUCTED 1 Piece Smooth T-Grid SPRNK
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
24 Airlock 100K DUCTED 1 Piece Smooth SUSP SPRNK
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
25 Airlock 10K DUCTED 1 Piece Smooth SUSP SPRNK
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
26 Airlock 1K DUCTED 1 Piece Smooth SUSP SPRNK
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
27 Aseptic Vials Receiving DUCTED 1 Piece Smooth SUSP SPRNK
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
28 Records DUCTED 1 Piece Smooth SUSP SPRNK
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
29 QC Radiometric DUCTED 1 Piece Smooth SUSP SPRNK
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
30 Radio Assay DUCTED 1 Piece Smooth SUSP SPRNK
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
31 Glass Washing Vial DUCTED 1 Piece Smooth SUSP SPRNK
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
32 Quarantine DUCTED 1 Piece Smooth T-Grid SPRNK
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
33 Label Storage DUCTED 1 Piece Smooth SUSP SPRNK
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
34 Stability DUCTED 1 Piece Smooth SUSP SPRNK
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
35 HP Lab DUCTED 1 Piece Smooth SUSP SPRNK
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
36 Label Room DUCTED 1 Piece Smooth SUSP SPRNK
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
37 Radiological Control Area DUCTED 1 Piece Smooth SUSP SPRNK
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
38 Frisk Room DUCTED 1 Piece Smooth SUSP SPRNK
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
39 Men's Lockers DUCTED 1 Piece Smooth SUSP SPRNK
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
40 Men's Sinks DUCTED 1 Piece Smooth SUSP SPRNK
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
41 Men's Toilets DUCTED 1 Piece Smooth SUSP SPRNK
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
42 Decontamination DUCTED 1 Piece Smooth SUSP SPRNK
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
43 Women's Restroom DUCTED 1 Piece Smooth SUSP SPRNK
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
44 Women's Lockers DUCTED 1 Piece Smooth SUSP SPRNK
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
45 Women's Sinks DUCTED 1 Piece Smooth SUSP SPRNK
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
46 Women's Toilets DBWALL 1 Piece Smooth T-Grid SPRNK
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
47 Airlock 100K DUCTED 1 Piece Smooth SUSP SPRNK
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
48 Airlock 10K DUCTED 1 Piece Smooth SUSP SPRNK
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
49 Sterility Lab DUCTED 1 Piece Smooth T-Grid SPRNK
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
50 Micro Prep DUCTED 1 Piece Smooth SUSP SPRNK
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
</TABLE>
J-21
<PAGE>
Section J List of Documents, Exhibits, and other Attachments
<TABLE>
<CAPTION>
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
Room No. Room Name Return HVAC Floor Wall Ceiling Fire Other
Type Zone Type Type Type Protect
<S> <C> <C> <C> <C> <C> <C> <C> <C>
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
51 Chemistry Records DUCTED 1 Piece Smooth SUSP SPRNK
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
52 Micro Lab DUCTED 1 Piece Smooth SUSP SPRNK
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
53 Incubator DUCTED 1 Piece Smooth SUSP SPRNK
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
54 QA Records DUCTED 1 Piece Smooth SUSP SPRNK
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
59 Hallway DUCTED 1 Piece Smooth SUSP SPRNK
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
60 Unpacking Room DUCTED 1 Piece Smooth SUSP SPRNK
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
61 Autoclave Tech Room DUCTED 1 Piece Smooth SUSP SPRNK
- --------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
</TABLE>
J-22
<PAGE>
Section J List of Documents, Exhibits, and other Attachments
<TABLE>
<CAPTION>
- --------- -------------------------- ------------------------------------------------------------------------
Room No. Room Name Equipment
- --------- -------------------------- ------------------------------------------------------------------------
<S> <C> <C>
1 Process Materials Storage
- --------- -------------------------- ------------------------------------------------------------------------
2 Airlock #1
- --------- -------------------------- ------------------------------------------------------------------------
3 RadioPharm Lab #1 Controlled Process Box (Class 100), Filling Machine, Movable Clean Air
Projector
- --------- -------------------------- ------------------------------------------------------------------------
4 RadioPharm Lab #2 Controlled Process Box (Class 100), Filling Machine, Movable Clean Air
Projector
- --------- -------------------------- ------------------------------------------------------------------------
5 RadioPharm Lab #3 Controlled Process Box (Class 100), Filling Machine, Movable Clean Air
Projector
- --------- -------------------------- ------------------------------------------------------------------------
6 RadioPharm Lab #4 Controlled Process Box (Class 100), Filling Machine, Movable Clean Air
Projector
- --------- -------------------------- ------------------------------------------------------------------------
7 RadioPharm Lab #5 Controlled Process Box (Class 100), Filling Machine, Movable Clean Air
Projector
- --------- -------------------------- ------------------------------------------------------------------------
8 RadioPharm Lab #6 Controlled Process Box (Class 100), Filling Machine, Movable Clean Air
Projector
- --------- -------------------------- ------------------------------------------------------------------------
9 Hallway
- --------- -------------------------- ------------------------------------------------------------------------
10 Airlock #2
- --------- -------------------------- ------------------------------------------------------------------------
11 Autoclave & Storage Autoclave, Pyrogen Oven
- --------- -------------------------- ------------------------------------------------------------------------
12 Assay 4 Dose Calibrator Ionization Chambers, Computer
- --------- -------------------------- ------------------------------------------------------------------------
13 Lead Pig Storage
- --------- -------------------------- ------------------------------------------------------------------------
14 Radiological Control Area
- --------- -------------------------- ------------------------------------------------------------------------
15 Hallway
- --------- -------------------------- ------------------------------------------------------------------------
16 QC Analytical Lab
- --------- -------------------------- ------------------------------------------------------------------------
17 Pre Package 1
- --------- -------------------------- ------------------------------------------------------------------------
18 Vial Fill #1
- --------- -------------------------- ------------------------------------------------------------------------
19 Airlock 100K
- --------- -------------------------- ------------------------------------------------------------------------
20 Airlock 10K
- --------- -------------------------- ------------------------------------------------------------------------
21 Vial Fill #2
- --------- -------------------------- ------------------------------------------------------------------------
22 Cold Chemistry
- --------- -------------------------- ------------------------------------------------------------------------
23 Pre Package 2 Crimping Machine, Moveable Clean Air Projector
- --------- -------------------------- ------------------------------------------------------------------------
24 Airlock 100K
- --------- -------------------------- ------------------------------------------------------------------------
25 Airlock 10K
- --------- -------------------------- ------------------------------------------------------------------------
26 Airlock 1K
- --------- -------------------------- ------------------------------------------------------------------------
27 Aseptic Vials Receiving Stoppering Machine
- --------- -------------------------- ------------------------------------------------------------------------
28 Quarantine
- --------- -------------------------- ------------------------------------------------------------------------
29 QC Radiometric
- --------- -------------------------- ------------------------------------------------------------------------
30 Radio Assay HPGe Gamma Detector
- --------- -------------------------- ------------------------------------------------------------------------
31 Glass Washing Vial Vial Washer, Stopper Washer, Dbl Door Autoclave, Dbl Door Hot Air
Sterilizer
- --------- -------------------------- ------------------------------------------------------------------------
32 Quarantine
- --------- -------------------------- ------------------------------------------------------------------------
33 Label Storage Labeling Machine
- --------- -------------------------- ------------------------------------------------------------------------
34 Stability Stability Chambers
- --------- -------------------------- ------------------------------------------------------------------------
35 HP Lab Misc HP Equipment/Detectors
- --------- -------------------------- ------------------------------------------------------------------------
36 Label Room Computer/Printer
- --------- -------------------------- ------------------------------------------------------------------------
37 Radiological Control Area
- --------- -------------------------- ------------------------------------------------------------------------
38 Frisk Room Survey Instruments
- --------- -------------------------- ------------------------------------------------------------------------
39 Men's Lockers
- --------- -------------------------- ------------------------------------------------------------------------
40 Men's Sinks
- --------- -------------------------- ------------------------------------------------------------------------
41 Men's Toilets
- --------- -------------------------- ------------------------------------------------------------------------
42 Gowning
- --------- -------------------------- ------------------------------------------------------------------------
43 cGMP Cleaning Materials
- --------- -------------------------- ------------------------------------------------------------------------
44 Women's Lockers
- --------- -------------------------- ------------------------------------------------------------------------
45 Women's Sinks
- --------- -------------------------- ------------------------------------------------------------------------
46 Women's Toilets
- --------- -------------------------- ------------------------------------------------------------------------
47 Airlock 100K
- --------- -------------------------- ------------------------------------------------------------------------
48 Airlock 10K
- --------- -------------------------- ------------------------------------------------------------------------
49 Sterility Lab
- --------- -------------------------- ------------------------------------------------------------------------
50 Micro Prep
- --------- -------------------------- ------------------------------------------------------------------------
</TABLE>
J-23
<PAGE>
Section J List of Documents, Exhibits, and other Attachments
<TABLE>
<CAPTION>
- --------- -------------------------- ------------------------------------------------------------------------
Room No. Room Name Equipment
- --------- -------------------------- ------------------------------------------------------------------------
<S> <C> <C>
51 Chemistry Records
- --------- -------------------------- ------------------------------------------------------------------------
52 Micro Lab
- --------- -------------------------- ------------------------------------------------------------------------
53 Inclubator Incubators
- --------- -------------------------- ------------------------------------------------------------------------
54 QA Records
- --------- -------------------------- ------------------------------------------------------------------------
59 Hallway
- --------- -------------------------- ------------------------------------------------------------------------
60 Unpacking Room
- --------- -------------------------- ------------------------------------------------------------------------
61 Autoclave Tech Room Autoclave
- --------- -------------------------- ------------------------------------------------------------------------
</TABLE>
J-24
<PAGE>
Section J List of Documents, Exhibits, and other Attachments
<TABLE>
<CAPTION>
Utilities Schedule
- --------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
Room No. Room Name TW PW SD FD HD IC WFI CA N(2) VAC
- --------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
<S> <C> <C> <C> <C> <C> <C> <C> <C> <C> <C> <C>
1 Process Materials
Storage
- --------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
2 Airlock #1 x . x
+sink
- --------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
3 RadioPharm Lab #1 . . x-GB x x-GB x-GB x-GB
- --------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
4 RadioPharm Lab #2 . x-GB x x-GB x-GB x-GB
- --------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
5 RadioPharm Lab #3 . x-GB x x-GB x-GB x-GB
- --------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
6 RadioPharm Lab #4 . x x-GB x x x-GB x-GB x-GB
- --------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
7 RadioPharm Lab #5 . x-GB x x-GB x-GB x-GB
- --------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
8 RadioPharm Lab #6 . x-GB x x-GB x-GB x-GB
- --------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
9 Hallway
- --------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
10 Airlock #2
- --------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
11 Autoclave & Storage x x x x x x
- --------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
12 Assay
- --------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
13 Lead Pig Storage x
- --------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
14 Radiological Control
Area
- --------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
15 Hallway
- --------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
16 QC Analytical Lab x x x x x x x-
-hood -hood hood
- --------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
17 Pre Package Lab x
- --------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
18 Vial Fill #1 x x x x x-GB x-GB x-GB
- --------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
19 Airlock 100K x+sink
- --------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
20 Airlock 10K
- --------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
21 Vial Fill #2 x x x x-GB x-GB x-GB
- --------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
22 Cold Chemistry Lab x x x x x-GB x-GB
- --------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
23 Pre Package 2 x
- --------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
24 Airlock 100K x x+sink
- --------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
25 Airlock 10K
- --------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
26 Airlock 1K
- --------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
27 Aseptic Vials x
Receiving
- --------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
28 Quarantine
- --------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
29 QC Radiometric x x x x x x
-hood -hood -hood
- --------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
30 Radio Assay
- --------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
31 Glass Washing Vial x x x+sink 3x x x x x x
- --------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
32 Quarantine
- --------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
33 Label Storage x
- --------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
34 Stability x x
- --------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
35 HP Lab x
- --------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
36 Label Room
- --------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
37 Radiological Control
Area
- --------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
38 Frisk Room x x
- --------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
39 Men's Lockers x x
- --------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
40 Men's Sinks x x
- --------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
41 Men's Toilets x x
- --------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
42 Degowning . .
- --------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
43 cGMP Closet x x
- --------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
44 Women's Lockers x x
- --------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
45 Women's Sinks x x
- --------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
46 Women's Toilets x x
- --------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
47 Airlock 100k x x+sink
- --------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
48 Airlock 10K
- --------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
49 Sterility Lab 1k
- --------- ----------------------- ------ ------ ------- ------ ------ ------ ------- ------- ------ ------
50 Micro Prep x x x
- --------- ----------------------- ------ ------ ------- ------ ------ ------ ------- ------- ------ ------
51 Chemistry Records
- --------- ----------------------- ------ ------ ------- ------ ------ ------ ------- ------- ------ ------
52 Micro Lab x x x x x
- --------- ----------------------- ------ ------ ------- ------ ------ ------ ------- ------- ------ ------
53 Incubator x x
- --------- ----------------------- ------ ------ ------- ------ ------ ------ ------- ------- ------ ------
54 QA Records
- --------- ----------------------- ------ ------ ------- ------ ------ ------ ------- ------- ------ ------
59 Hallway
- --------- ----------------------- ------ ------ ------- ------ ------ ------ ------- ------- ------ ------
60 Unpacking Room
- --------- ----------------------- ------ ------ ------- ------ ------ ------ ------- ------- ------ ------
61 Autoclave Tech Room x
- --------- ----------------------- ------ ------ ------- ------ ------ ------ ------- ------- ------ ------
</TABLE>
TW=Hot and Cold Tap Water PW=Purified Water USP SD=Sink Drain FD=Floor Drain
VAC=Vacuum N2 =Nitrogen HD=Drain for radioactive liquids IC=Intercom System
SCS=Safety Communication System CA=Compressed Air GB=Glove Box -Provide Valved
Connection 4' from corner/ 8' above FFL
J-25
<PAGE>
Section K Representations and Certifications
ARTICLE K-1: CORPORATE STATUS Seller is a Sole Proprietorship __N/A___.
Seller is a Partnership duly organized, valid and existing and in good standing
under the laws of ______N/A_________.
Seller is a Corporation duly organized, valid and existing and in good standing
under the laws of Delaware.
ARTICLE K-2: AUTHORITY
The execution, delivery and performance of this Contract and all other
agreements, instruments and documents to be delivered hereunder have been duly
and validly authorized by the Board of Directors of Seller or other appropriate
authority. No other action must be taken to make this Contract and all other
agreements, instruments and documents to be executed and delivered hereunder,
valid and legally binding upon Seller in accordance with their respective terms,
subject to general principles of equity and accept as enforceability thereof may
be limited by applicable bankruptcy, insolvency, reorganization or other similar
laws of general application relating to creditors' rights.
ARTICLE K-3: COMPLIANCE WITH LAW
Seller has complied with and is not in violation of applicable statutes, laws
and regulations which would affect its ability to perform its respective
obligations hereunder.
ARTICLE K-4: WORKMAN'S COMPENSATION INSURANCE
Seller certifies that during the term of this contract that he will maintain, at
his expense workmen's compensation insurance and comprehensive liability
insurance, providing coverage against liability for bodily injury, death, and
property damage, in the minimum amount of $1,000,000 per occurrance.
Certificates regarding such coverage are available upon request.
K-31
<PAGE>
Signature Page
- --------------------------------------------------------------------------------
Contract Number: PM-801
Mod Number: Orig
Date: 2/06/98
- --------------------------------------------------------------------------------
The above pages, through this page and including any attachments referenced
herein, constitute the full content of this contract between International
Isotopes Inc. and MSS Technologies.
SIGNATURES
Executed as of February 5, 1998
SELLER INTERNATIONAL ISOTOPES INC.
<TABLE>
<CAPTION>
By: /s/ James Kavanagh By: /s/ Ira Lon Morgan By: /s/ Tomy Thompson
------------------ -------------------- ------------------
<S> <C> <C>
Name: James Kavanagh Name: Ira Lon Morgan Name: Tommy Thompson
Title: Vice-President Title: Chairman Title: Exec. Vice President
Date: 2/5/98 Date: 2/5/98 Date: 2/5/98
</TABLE>
<TABLE> <S> <C>
<ARTICLE> 5
<CIK> 0001038277
<NAME> International Isotopes
<MULTIPLIER> 1
<CURRENCY> USD
<S> <C>
<PERIOD-TYPE> 3-MOS
<FISCAL-YEAR-END> DEC-31-1998
<PERIOD-START> JAN-31-1998
<PERIOD-END> MAR-31-1998
<EXCHANGE-RATE> 1
<CASH> 8,530,554
<SECURITIES> 277,803
<RECEIVABLES> 111,143
<ALLOWANCES> 0
<INVENTORY> 748,853
<CURRENT-ASSETS> 10,267,655
<PP&E> 10,606,729
<DEPRECIATION> 29,290
<TOTAL-ASSETS> 20,845,094
<CURRENT-LIABILITIES> 1862,109
<BONDS> 0
0
0
<COMMON> 63,709
<OTHER-SE> 0
<TOTAL-LIABILITY-AND-EQUITY> 20,845,094
<SALES> 150,000
<TOTAL-REVENUES> 150,000
<CGS> 62,830
<TOTAL-COSTS> 62,830
<OTHER-EXPENSES> 0
<LOSS-PROVISION> 0
<INTEREST-EXPENSE> 0
<INCOME-PRETAX> (573,033)
<INCOME-TAX> 15,000
<INCOME-CONTINUING> (588,033)
<DISCONTINUED> 0
<EXTRAORDINARY> 0
<CHANGES> 0
<NET-INCOME> (588,033)
<EPS-PRIMARY> (0.9)
<EPS-DILUTED> (0.9)
</TABLE>
