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SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 10-K
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES ACT OF 1934
For Fiscal Year Ended March 31, 1999
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Commission File Number 0-23252
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IGEN INTERNATIONAL, INC.
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(Exact name of registrant as specified in its charter)
DELAWARE 94-2852543
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(State or other jurisdiction of (IRS Employer Identification No.)
incorporation or organization)
16020 INDUSTRIAL DRIVE, GAITHERSBURG, MD 20877
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(Address of principal executive offices) (Zip Code)
301/984-8000
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(Registrant's telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act: NONE
Securities registered pursuant to Section 12(g)
of the Act: COMMON STOCK $0.001 PAR VALUE
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(Title of Class)
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
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Indicate by check mark if disclosure of delinquent filers pursuant to Item 405
of Regulation S-K is not contained herein, and will not be contained to the best
of Registrant's knowledge, in definitive proxy or information statements
incorporated by reference in Part III of this Form 10-K or any amendment to this
form 10-K. _
The aggregate market value of the voting and non-voting equity held by
non-affiliates of the Registrant as of June 11, 1999, computed by reference to
the closing sale price of such stock quoted on the Nasdaq National Market, was
approximately $271,638,100. For the purposes of this calculation, shares owned
by officers, directors and 5% shareholders known to the Registrant have been
deemed to be owned by affiliates.
The number of shares outstanding of the Registrant's Common Stock as of June 11,
1999 was 15,372,600.
DOCUMENTS INCORPORATED BY REFERENCE
The following documents (or parts thereof) are incorporated by reference into
the following parts of this Form 10-K. Certain information required in Part III
of this Annual Report on Form 10-K is incorporated from the Company's definitive
Proxy Statement relating to its Annual Meeting of Shareholders to be held on
September 15, 1999.
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PART I
IN ADDITION TO HISTORICAL INFORMATION THIS DOCUMENT CONTAINS FORWARD-LOOKING
STATEMENTS WITHIN THE MEANING OF THE "SAFE HARBOR" PROVISION OF THE PRIVATE
SECURITIES LITIGATION REFORM ACT OF 1995. REFERENCE IS MADE IN PARTICULAR TO
STATEMENTS REGARDING THE POTENTIAL MARKET FOR DIAGNOSTIC PRODUCTS, POTENTIAL
IMPACT OF COMPETITIVE PRODUCTS, THE COMPANY'S EXPECTATIONS REGARDING THE LEVEL
OF ANTICIPATED ROYALTY AND REVENUE GROWTH IN THE FUTURE, THE POTENTIAL MARKET
FOR PRODUCTS IN DEVELOPMENT, THE OUTCOME OF LITIGATION, THE DESCRIPTION OF THE
COMPANY'S PLANS AND OBJECTIVES FOR FUTURE OPERATIONS, ASSUMPTIONS UNDERLYING
SUCH PLANS AND OBJECTIVES AND OTHER FORWARD-LOOKING STATEMENTS INCLUDED IN ITEM
7 - "MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS" ("MD&A"). SUCH STATEMENTS ARE BASED ON MANAGEMENT'S CURRENT
EXPECTATIONS AND ARE SUBJECT TO A NUMBER OF FACTORS AND UNCERTAINTIES WHICH
COULD CAUSE ACTUAL RESULTS TO DIFFER MATERIALLY FROM THOSE DESCRIBED IN THE
FORWARD-LOOKING STATEMENTS. IN PARTICULAR, CAREFUL CONSIDERATION SHOULD BE GIVEN
TO CAUTIONARY STATEMENTS MADE IN ITEM 7 - "MANAGEMENT'S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS" AND IN ITEM 1 - "BUSINESS"
UNDER THE HEADING "RISK FACTORS." IGEN DISCLAIMS ANY INTENT OR OBLIGATION TO
UPDATE THESE FORWARD-LOOKING STATEMENTS.
ITEM 1. BUSINESS
IGEN International, Inc. ("IGEN" or the "Company"), together with collaborators,
develops, manufactures and markets diagnostic systems utilizing IGEN's patented
ORIGEN technology, which is based on electrochemiluminescence ("ECL"), a
universal diagnostic platform which addresses many segments of the diagnostics
industry. The Company believes that ORIGEN-based diagnostic products offer
significant advantages over existing systems by providing a combination of
enhanced speed, sensitivity, flexibility, throughput and cost effectiveness. The
Company and its collaborators design ORIGEN-based diagnostic systems for
multiple segments of the $20 billion worldwide diagnostic market, from hospital
and clinical reference laboratories to patient point-of-care, life science
research, industrial and in-home testing.
The Company has commercialized certain first generation ORIGEN-based products
for large, established markets, such as clinical reference and central hospital
laboratories, in collaboration with leading healthcare companies. All of these
products feature the ORIGEN technology as the central diagnostic operating
system. There are six ORIGEN-based product lines on the market generating
revenues from equipment and recurring reagent sales which are being sold either
by IGEN or its licensees. The Company estimates that approximately 5,000 of
these systems have been sold or placed with customers, with more than 75% of
these systems having been placed or sold in the last 24 months. The Company
directly markets two product lines, the M-SERIES High Throughput Screening
system and the ORIGEN Detection System, along with related reagents and
services, for life science research applications. Leveraging on its success in
developing and commercializing the first generation of ORIGEN-based products,
the Company's strategy is to expand its role in the manufacturing and marketing
of a new generation of ORIGEN-based products to create a universal diagnostic
platform for potential high-growth market segments, including patient
point-of-care, high throughput drug screening ("HTS") (life science research),
and food, water and animal health testing (industrial). To facilitate marketing
and distribution in certain of these new market segments, the Company may enter
into corporate collaborations.
The Company has recently completed the development of a second generation of the
ORIGEN-based system, the ECL Module ("ECLM"). The Company developed the ECLM to
be a self-contained, fully-functional
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diagnostic operating system that approximates 1/20th the size of, and is fully
compatible with, the first generation ORIGEN operating system. The ECLM reduces
the time and cost required to incorporate ORIGEN technology into many diagnostic
or analytical instruments. Because the ECLM combines small size and relatively
low cost, with speed, accuracy and sensitivity equal to the first generation of
ORIGEN-based products, the Company believes that the ECLM will accelerate the
development of products for potential high-growth market segments.
In the life science research market, IGEN has developed and is marketing the
first ECLM-based product, the M-SERIES High Throughput Screening System, for use
by biopharmaceutical companies in the drug discovery process. IGEN believes that
screening specific drug targets against libraries containing hundreds of
thousands of potential drug candidates is one of the most difficult challenges
in the biopharmaceutical industry. The M-SERIES was developed to enable the
rapid development of HTS assays and should allow biopharmaceutical companies to
perform thousands of screens per day at less cost and with greater reliability.
Leveraging on IGEN's extensive pharmaceutical contacts and its reputation in the
life science research market, the Company established its first contracts with
customers in the HTS market. Commitments to acquire the M-SERIES have been made
by Pfizer, Amgen, Bristol-Myers Squibb, Schering Plough, Merck, Abbott
Laboratories, Novo Nordisk, Agouron, Peptide Therapeutics, Zymogenetics,
Battelle and the John Wayne Cancer Institute. Shipments of the first two
M-SERIES pre-production units occurred in March, 1999.
In the point-of-care market, the Company believes that ECLM-based devices should
allow for a broad diagnostic menu, faster turnaround of tests, more accurate
diagnosis and, therefore, better and more cost-effective patient care. The broad
menu of immunoassays that has been developed by IGEN and its collaborators for
the first generation of ORIGEN-based products can be performed on, and is
available for use with, ECLM-based devices for the point-of-care market. IGEN is
currently exploring collaborative business arrangements to accelerate the
commercialization of ECLM-based products for multiple point-of-care
applications.
In the industrial market, IGEN has performed field evaluations of its ORIGEN
test for E. coli bacteria in meat and other foods with the U.S. Department of
Agriculture ("USDA") and two major food producers. This test, developed in
conjunction with the USDA Agricultural Research Service, is used in testing food
and beverage products, such as meat used in hamburger, for the bacteria which
have caused numerous outbreaks of gastrointestinal and renal disease worldwide.
According to published studies by the USDA, the ORIGEN-based test, which is
automated and creates a permanent record of test results, is 1,000 times more
sensitive and significantly faster than existing E.coli tests.
The Company has entered into collaborations with established diagnostic and
pharmaceutical companies which have provided IGEN with $80 million in license
fees and product development and marketing resources, in addition to royalties
on product sales. In 1997, revenues from these collaborations substantially
shifted from up-front license fees to royalties based on sales of equipment and
reagents.
- The Company has a collaboration with Roche Diagnostics ("Roche"),
the largest worldwide manufacturer of diagnostic equipment and
supplies, to commercialize ORIGEN-based clinical immunodiagnostic
and nucleic acid probe systems that are marketed worldwide to
central hospital and clinical reference laboratories. IGEN has
received $50 million in license fees from Roche and receives
royalties on product sales. Roche presently markets two
ORIGEN-based systems under the Elecsys product line together with
a test menu of more than 35 different
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assays (including tests for infectious diseases, anemia, cancer,
heart attacks, thyroid disease and fertility/pregnancy, as well as
other tests).
IGEN has filed a lawsuit in Maryland against Roche, which claims
multiple breaches of the license agreement between the parties and
failure by Roche to perform its material obligations under the
agreement. The timing or likelihood of resolving this matter
cannot be determined at this time. See Item 3 - "Legal
Proceedings."
- The Company has an agreement with Organon Teknika B.V. ("Organon
Teknika"), a company specializing in hospital and blood bank
products, which is a business unit of Akzo Nobel N.V., a
multinational corporation with annual revenues of approximately
$12 billion, to develop and commercialize ORIGEN-based nucleic
acid probe systems that will be marketed worldwide to clinical
diagnostic and life science research markets. Organon Teknika has
combined its proprietary nucleic acid sequence based amplification
("NASBA") technology with ORIGEN technology and markets the
NucliSens line of diagnostic virology products together with test
kits for the detection of HIV-1 RNA and CMV (cytomegalo virus).
IGEN has received $20 million under its agreements with Organon
Teknika and currently receives royalties on product sales.
- IGEN has a collaboration with Eisai Co., Ltd. ("Eisai"), a leading
Japanese pharmaceutical company, to market in Japan an
ORIGEN-based diagnostic system for agreed-upon diagnostic tests
currently focused primarily in the cancer area. Eisai introduced
its first ORIGEN-based product under the trade name Picolumi
during 1997 and IGEN receives royalties on product sales.
IGEN's executive offices, laboratories and manufacturing operations are located
at 16020 Industrial Drive, Gaithersburg, Maryland 20877.
INDUSTRY BACKGROUND
IN VITRO diagnostic testing is the process of analyzing blood, urine and other
specimens to screen for, monitor and diagnose diseases and other medical
conditions or to determine the chemical and microbiological constituents of the
specimens. The major IN VITRO procedures include immunodiagnostic, nucleic acid
probe and chemistry tests. The worldwide IN VITRO diagnostic market opportunity
for IGEN is estimated to be approximately $20.0 billion and includes diagnostic
procedures performed in three primary markets: (i) the clinical diagnostic
market, including central hospital laboratories, clinical reference laboratories
and blood banks, which are collectively estimated at $14.0 billion, and patient
point-of-care testing and home testing, which are collectively estimated at $2.0
billion; (ii) the life science research market, which is estimated at $2.0
billion, including laboratories in pharmaceutical and biotechnology companies,
universities, private institutes and the government; and (iii) the industrial
market, which is estimated at $2.0 billion, including food and water quality
assurance programs, agricultural diagnostics and animal health testing.
Immunodiagnostic tests utilize antibodies to detect specific analytes such as
viruses, hormones, therapeutic drugs and other substances present in the blood
or other specimens in extremely low concentrations. To develop an
immunodiagnostic test, an antibody is created that binds specifically to
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the analyte to be detected. The antibody is then coupled to a label that signals
to an instrument the presence of the analyte in a way that can be measured.
Immunodiagnostic tests are characterized by a relatively high rate of
technological change and the frequent introduction of new clinical tests.
Currently, most immunodiagnostic tests are performed in large centralized
hospital laboratories and clinical reference laboratories by skilled technicians
who must process the specimen, measure its volume, add reagents and use
sophisticated machines to read and calculate the results.
Nucleic acid probe tests allow the detection of disease at the fundamental
genetic level. The absence or presence of certain genes or gene mutations have
been found to be reliable indicators of specific cancers, genetic disorders and
infectious diseases. Nucleic acid probes provide a direct means of detecting
nucleic acid sequences associated with either infectious agents or certain genes
in a biological sample. One difficulty in the development of nucleic acid-based
diagnostic technology is the low concentration of nucleic acid in the sample,
which generally renders direct detection impractical. Recent solutions to this
problem, including the DNA Polymerase Chain Reaction ("PCR") and NASBA, are
capable of amplifying trace amounts of target nucleic acid hundreds of millions
of times and allow for the detection of disease-causing genes before symptoms
appear.
Chemistry tests utilize established analytical methods for measuring simple
compounds such as glucose and cholesterol, elements such as sodium and
potassium, gases and enzymes. The types of samples that can be analyzed include
biological specimens such as blood and urine as well as environmental materials,
foods and beverages. The results of the analysis can be qualitative, identifying
only the presence or absence of an analyte, or quantitative, identifying also
the precise level of the analyte in the specimen.
ORIGEN TECHNOLOGY
The ORIGEN technology is a proprietary technology based on ECL, which utilizes
labels that, when attached to a biological substance and electrochemically
stimulated, emit light at a particular wavelength to signal the presence of an
analyte. The light emission can then be measured with a high degree of accuracy
to detect and quantify the analyte. The Company's ORIGEN technology thus
provides a uniform assay format to conduct a multitude of diagnostic tests
including immunoassay, nucleic acid probe and clinical chemistry tests. The
ORIGEN technology is protected by numerous patents in the United States and
internationally.
IGEN and its collaborators are using the ORIGEN technology to develop and
commercialize diagnostic systems that offer many advantages over current
technologies. The Company believes that its ORIGEN technology offers improved
speed, sensitivity, flexibility and throughput relative to existing diagnostic
technologies and lowers the cost of diagnostic procedures. The ORIGEN system
directly measures ECL, and does not involve the use of enzymes common in
competing systems, thus permitting a simplified assay format. The ORIGEN
diagnostic systems can be automated to provide in a uniform format a large
number of immunoassay, nucleic acid probe and clinical chemistry tests. The
essential component of the ORIGEN system is the measurement module, which
consists of a flow cell containing an electrode and a light detection means such
as a photodiode. The ORIGEN measurement module has been designed so that it can
be easily incorporated into a variety of instruments from large central
laboratory random-access systems to small batch systems. The major features and
benefits of proprietary ORIGEN-based diagnostic systems are:
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<TABLE>
<CAPTION>
FEATURE BENEFIT
<S> <C>
Simple Assay Format Reduces time and labor in performing an assay.
Flexibility Enables a single instrument to perform
immunoassays on large and small
molecules and to perform DNA and RNA
probe assays.
Cost Reduces assay cost per test.
Speed Produces quick results.
Enables high throughput (random access).
Sensitivity Allows detection of analytes at very low concentrations.
Precision Provides highly-reproducible measurements.
Label Stability Extends reagent shelf life. Improves measurement
accuracy.
</TABLE>
The Company has recently completed the development of a new generation of ORIGEN
technology, the ECLM. The Company developed ECLM to be a self-contained,
fully-functional diagnostic operating system that is 1/20th the size of, and
fully compatible with, the first generation ORIGEN operating system. The ECLM
reduces the time and cost required to incorporate ORIGEN technology into many
diagnostic or analytical instruments. Because the ECLM combines small size and
relatively low cost, with speed, accuracy and sensitivity equal to the first
generation of ORIGEN products, the Company believes that the ECLM will
accelerate the development of products for potential high-growth market
segments.
ORIGEN-BASED PRODUCTS
The Company is designing its diagnostic systems to create a universal diagnostic
platform for all segments of the diagnostic market, from large central
laboratories to patient point-of-care and in-home testing. The Company believes
that its ORIGEN-based technology is well suited for the development of a family
of instruments to be used in all segments of the market. The technology permits
virtually all clinical chemistry, immunodiagnostic, nucleic acid tests and tests
to be performed on the same instrument using the same detection method.
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The following table summarizes the Company's products and development
programs.
<TABLE>
<CAPTION>
COMMERCIAL
MARKET PRODUCT APPLICATION RIGHTS STATUS
<S> <C> <C> <C> <C>
CLINICAL DIAGNOSTIC MARKET
HOSPITAL/REFERENCE LABORATORY
SYSTEMS Elecsys 2010 Immunoassays Roche Product Sales
Elecsys 1010 Immunoassays Roche Product Sales
NucliSens/NASBA QR Nucleic Acid Probe Organon Teknika Product Sales
Detection
Picolumi Immunoassays (Japan) Eisai (Japan) Product Sales
High Throughput Elecsys Immunoassays Roche Development
System (Modular)
PATIENT POINT-OF-CARE SYSTEMS Physician Office-Elecsys Immunoassays IGEN (1) Product Sales
Physician's Office/Portable Immunoassays/Clinical IGEN Development
Hospital Analyzer Chemistry
LIFE SCIENCE RESEARCH MARKET Home Self-Testing Health Screening and IGEN Research
Monitoring
M-SERIES High Throughput Immunoassay/Nucleic Acid IGEN Product Sales
System Probe
ORIGEN Detection System and Immunoassays/Nucleic Acid IGEN Product Sales
Reagents Probe
Cell Culture Reagents Research Biologicals IGEN Product Sales
NucliSens/NASBA QR Nucleic Acid Probes Organon Teknika Product Sales
INDUSTRIAL MARKETS Environmental/Water Immunoassays and Nucleic IGEN; Development/
Testing/Food Processing Acid Probe Detection Organon Teknika Field Studies
System
Animal Health Systems Immunoassays and Nucleic IGEN Development
Acid Probe Detection
</TABLE>
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1 IGEN currently servicing customers pursuant to preliminary injunction issued
by the Court in October, 1998.
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CLINICAL DIAGNOSTIC PRODUCTS
HOSPITAL/REFERENCE LABORATORY SYSTEMS. One of the significant applications of
the Company's ORIGEN technology is in large, highly-automated clinical
immunoassay systems of the type used in central hospital laboratories, clinical
reference laboratories and blood banks. Reference laboratories constitute the
vast majority of the clinical diagnostic market today. Reference laboratory
systems must be able to perform a wide variety of immunoassay tests on a large
number of samples both reliably and cost-effectively. The Company and its
corporate collaborators believe that systems based on the ORIGEN technology are
well suited to serve this market, and may surpass those immunoassay and nucleic
acid probe systems currently available in terms of speed, cost effectiveness and
ease of use.
One of the Company's licensees, Roche, introduced its first ORIGEN-based
random-access immunoassay system, the Elecsys 2010, for the central hospital and
reference laboratory markets in 1996. The Elecsys 2010 is designed to perform
multiple assays in a random-access mode while handling STAT tests (i.e., tests
performed on clinical samples where the results are needed immediately) without
interfering with the system workflow. Roche and Hitachi have cooperated in the
development of the Elecsys 2010, building on their successful cooperation in
clinical chemistry instrumentation. The Elecsys 2010 is designed so that it can
be integrated with Roche's clinical chemistry systems. Roche also introduced the
Elecsys 1010 system, which is a system designed for central hospital and
reference lab customers who have a lower throughput requirement. Roche offers a
competitive panel of more than 35 assays with the Elecsys systems, including
tests for infectious diseases, anemia, cancer, heart attacks, thyroid disease,
fertility/pregnancy, as well as other tests, and continues to develop additional
assays for market introduction in subsequent months and years. IGEN is
collaborating with Roche to develop additional assays for which IGEN is
reimbursed by Roche for certain of its assay development costs. Roche is also
developing the Modular, a high throughput Elecsys system. See Item 3 - "Legal
Proceedings" for a description of litigation between the Company and Roche.
IGEN and its licensee, Organon Teknika, believe that the ORIGEN technology
applied to nucleic acid probe assays will offer the advantages of greater
accuracy and efficiency that the market demands. Organon Teknika is developing
nucleic acid probe diagnostic tests that are used to analyze human gene
sequences or to detect the presence of gene sequences of infectious organisms.
Organon Teknika markets the NucliSens line of diagnostic virology products,
which combines the first nucleic acid probe system based on the ORIGEN
technology with NASBA. The NucliSens has four stages: sample preparation and
nucleic acid isolation, amplification and detection. The NASBA QR System
utilizes ORIGEN technology which provides automated, rapid, specific, sensitive
and homogenous detection. Tests on the market include a product for the direct
detection of HIV-1 RNA, both quantitatively and qualitatively, and for the
detection of CMV (cytomegalo virus). Products under development by Organon
Teknika include tests for hepatitis, chlamydia and mycobacteria. In addition to
the diagnosis of infectious disease, the NucliSens has potential applications in
the fields of genetic diseases, oncologic diseases and HLA typing for organ
transplants.
The Company's licensee in Japan, Eisai, launched its ORIGEN-based product,
the Picolumi, in 1997. The Picolumi consists of an immunodiagnostic
instrument and certain assays. Currently, there are four cancer tests on the
market and additional tests are in development.
PATIENT POINT-OF-CARE SYSTEMS. IGEN is independently developing ORIGEN-based
products that can be used to perform immunoassays and clinical chemistry tests
outside of large central laboratory settings. This market includes patient
point-of-care settings such as the physician's office, ambulatory clinics,
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hospital emergency rooms, surgical and intensive care units, hospital satellite
laboratories, nurse's stations or the hospital patient's bedside. Physicians,
patients and third-party payors have created a demand for bringing laboratory
testing closer to the patient in order to provide the medical practitioner with
faster results and, therefore, prompt feed-back to the patient. Immunodiagnostic
systems for individual physicians and group practices have had limited market
penetration because of the lengthy turnaround time for test results (1-2 days),
the need for skilled labor in performing tests and high cost. The Company
believes that the emergence of simple, accurate and cost effective diagnostic
products is shifting the site of IN VITRO diagnostic testing from the central
clinical laboratory to alternate sites.
IGEN believes that significant demand exists for immunodiagnostic and clinical
diagnostic products that reduce turnaround time and cost. IGEN's point-of-care
system is being designed to conduct tests that can provide accurate results to
the physician within 15 minutes, thereby permitting the physician to make a
timely decision regarding the patient's course of treatment. The ORIGEN
technology permits development of a system that is simple to operate at a very
low cost per test. The Company is designing its point-of-care system to consist
of a simple, low cost instrument and a line of reagents packaged in a disposable
single test or panel format. As most assays can be conducted on the ORIGEN
system in a uniform format, the Company believes that a broad menu of tests
could be marketed on its point-of-care system.
Longer-term applications of the ORIGEN technology also exist in the field of
in-home testing (patient self-testing), in which IGEN's technology may enable
the creation of compact, inexpensive diagnostic products. The Company is
exploring the feasibility of using its ORIGEN technology for such products.
LIFE SCIENCE RESEARCH PRODUCTS
M-SERIES HIGH THROUGHPUT SCREENING SYSTEM. IGEN believes that the need of
biopharmaceutical companies to find new drugs and advances in drug discovery
technologies has created an opportunity for the ORIGEN technology platform in
the biopharmaceutical industry. Advances in fields of combinatorial chemistry
and biotechnology have revolutionized drug discovery. With the advent of
combinatorial chemistry, biopharmaceutical companies have dramatically expanded
their drug candidate libraries. Developments in biotechnology and research
programs such as the Human Genome Project have greatly increased the
understanding of disease mechanisms and pathogens, providing novel therapeutic
targets. In order to exploit these advances, biopharmaceutical companies are
re-engineering their drug development processes. High Throughput Screening (HTS)
uses automation and the latest advances in technology to accelerate the
screening of compound libraries against the disease targets of interest.
In HTS, researchers are challenged to develop new target assays while reducing
costs and always processing larger numbers of samples. IGEN's ORIGEN technology
is ideally suited to provide products to the biopharmaceutical HTS market.
IGEN's M-SERIES High Throughput Screening System, based on the ECLM builds on
the applications of its first generation product, the ORIGEN Detection System.
The M-SERIES is compatible with 96 and 384 multi-well plates that are commonly
used in HTS laboratories, and can be fully integrated with existing automation
and robotic systems. It should allow researchers to perform thousands of tests
per day, with less cost and with greater sensitivity and reliability.
The sensitivity and accuracy of the M-SERIES has advantages over competitive
screening technologies. It allows the user to quickly adapt the ORIGEN
technology to target assays in weeks compared to the
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months taken today, to reduce the use of their rare reagent, and to be more
confident in their positive and negative results. IGEN's assay expertise assists
customers with assay feasibility, development and in the performance of assay
services under full GMP compliance.
During 1998, IGEN established its first contracts with customers in the HTS
market. Commitments to acquire the M-SERIES have been made by Pfizer, Amgen,
Bristol-Myers, Squibb, Schering Plough, Merck, Abbot Laboratories, Novo Nordisk,
Agouron, Peptide Therapeutics, Zymogenetics, Battelle, and the John Wayne Cancer
Institute. Shipments of the first two M-SERIES pre-production units occurred in
March 1999.
ORIGEN DETECTION SYSTEM. IGEN currently sells the ORIGEN Detection System and a
line of related reagents and services. The ORIGEN Detection System is used by
researchers who wish to perform immunoassays for life science applications. The
ORIGEN Detection System is an open architecture assay platform that quantitates
the binding affinity of any two molecules that come together with specificity.
The "open architecture" component of ORIGEN refers to the researcher's ability
to customize their assays for their particular performance parameters. The
System is optimized for immunoassays, but offers researchers the flexibility to
build other assays for direct detection of nucleic acids and receptor ligand
studies.
ORIGEN is being implemented throughout the life science market as a replacement
technology for Radioimmunoassays (RIA) and Enzyme Linked Immunosorbent Assays
(ELISA), the most commonly used systems, as well as a replacement for newer
chemiluminescent and fluorescent procedures. IGEN's market focus on
biopharmaceuticals has resulted in successful application of ORIGEN technology
by customers in drug discovery and development, compound screening, basic
research, clinical trials, quality control and manufacturing. Biopharmaceutical
researchers are benefiting from the ORIGEN Detection System's sensitivity as
well as the reduction of time and labor, and significantly, the reduction in use
of rare assay components such as proprietary compounds, antibodies, or clinical
trial samples.
While IGEN's market focus has been on immunodiagnostic applications for
biopharmaceutical customers, the Company also has customers at government and
university research centers. Certain of these customers are performing research
in strategic IGEN growth areas such as food and water quality testing. The
Company has also broadened its assay versatility by expanding into nucleic acid
probe applications. The Company believes that ORIGEN-based technology also
sensitively detects DNA without costly amplification steps.
RESEARCH BIOLOGICALS. The Company produces and sells a line of research reagents
under its ORIGEN brand name. The products are purified biological extracts that
promote the growth of certain types of cells used in laboratory investigations.
The Company markets the products directly as well as through distributors.
INDUSTRIAL PRODUCTS
The Company is seeking to develop further, either independently or with joint
venture partners, ORIGEN-based products for use in food and water quality
assurance programs and animal health testing. The emergence of simple, accurate
and cost effective products is shifting testing from traditional labor intensive
methods such as gas chromatography, to immunodiagnostics. The Company believes
that its ORIGEN Detection System and reagents together with simpler, low-cost,
ECLM-based instruments under development will be well-suited for these market
applications.
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The Company has performed field evaluations of its ORIGEN test for E.coli
bacteria in meat and other foods with the USDA and two major food producers.
This test, developed in conjunction with the USDA Agricultural Research Service,
is used in testing food and beverage products such as meat used in hamburger,
for the bacteria which have caused numerous outbreaks of gastrointestinal and
renal disease worldwide. According to published studies by the USDA, the
ORIGEN-based test, which is automated and creates a permanent record of test
results, is 1,000 times more sensitive and significantly faster than existing
E.coli tests.
Major food and beverage producers could become primary users of the E.coli test
to ensure continued safety of food and beverage products. The major advantages
of the ORIGEN test are its ability to perform in complex sample types like
hamburger meat, in less time, with a 1,000 fold increase in sensitivity over
available methods. The IGEN test will offer food producers the ability to
efficiently test many more food samples than available methods. In addition to
E.coli, IGEN will begin field evaluations soon of other ORIGEN-based food and
beverage safety tests, such as a test for cryptosporidium parasite developed in
conjunction with the Centers for Disease Control.
COLLABORATION AND LICENSE AGREEMENTS
IGEN's business strategy is to develop and market products both independently
and in collaboration with established healthcare companies. The Company's ORIGEN
technology has already provided near-term revenues, which have enabled the
Company to pursue its strategic objectives in the diagnostic business. IGEN may
seek additional corporate collaborations to accelerate commercialization of
ECLM-based products for point-of-care applications and to facilitate marketing
and distribution of its products in certain other markets.
ROCHE -- Roche Diagnostics GmbH ("Roche") is a subsidiary of F. Hoffmann
La-Roche Ltd. of Switzerland, a multinational corporation with annual revenues
exceeding $15 billion and the largest worldwide manufacturer of diagnostic
equipment and supplies. Roche's principal strength is in the areas of clinical
chemistry and nucleic acid probe systems, in which it is the market leader. The
Company entered into an agreement under which Roche was granted rights to
develop and market clinical diagnostic systems in certain markets worldwide
based on the Company's technology. Under the agreement, IGEN received $50
million in license fees over a five-year period ending in 1996. Roche pays
additional amounts for certain assay product development being performed by
IGEN, and is obligated to pay the Company a royalty on all product sales.
The ORIGEN products being marketed by Roche under the name Elecsys, are a series
of highly-automated diagnostic systems designed for central hospital
laboratories and clinical reference laboratories. IGEN believes that Elecsys
systems will enable Roche to increase its market presence in immunodiagnostics
and to market systems capable of performing both clinical chemistry and
immunodiagnostic tests. The Company estimates that Roche has placed or sold
approximately 5,000 Elecsys systems with customers since market introduction in
mid-1996. The Company has granted Roche an exclusive right to market these
products to central hospital laboratories and clinical reference laboratories
worldwide, except for rights previously licensed to Eisai to market contained
products in Japan. The Company has also granted Roche a co-exclusive license to
use the ORIGEN technology for nucleic acid probe tests for use in centralized
hospital laboratories and clinical reference laboratories. In addition, Roche
has granted to the Company a non-exclusive license to certain improvements for
products based on the ECL technology resulting from Roche's work under its
agreement with the
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Company. This "grant back" may be used only in fields other than central
hospital and clinical reference laboratories. The Company is involved in
litigation with Roche. See Item 3 -" Legal Proceedings."
The Company recorded royalty income and license fees from the Roche agreement of
$7.1 million, $4.4 million and $8.6 million for the three fiscal years ended
March 31, 1997, 1998 and 1999.
ORGANON TEKNIKA B.V. Organon Teknika, a company specializing in hospital and
blood bank products, is a business unit of Akzo Nobel N.V., a multinational
corporation with annual revenues of approximately $12 billion. In 1993, the
Company entered into a $20 million license agreement and a stock purchase
agreement with Organon Teknika. The license agreement provides Organon Teknika
with co-exclusive rights to commercialize certain products utilizing the
Company's ORIGEN technology for detecting nucleic acids in centralized clinical
markets, research markets and for certain pathogens for food testing. Organon
Teknika has combined the Company's ORIGEN technology with NASBA, a proprietary
nucleic acid amplification technique. The agreement provides for royalty
payments to IGEN and for product supply arrangements. The Company also issued
shares of Common Stock to Organon Teknika and agreed to devote specified
resources to research and development activities in the field of clinical
diagnostics. Robert Salsmans, a director of the Company, is President and Chief
Executive Officer of the Organon Teknika group of companies.
EISAI CO., LTD. Eisai is a major Japanese pharmaceutical company. The Company
granted a license to Eisai to market in Japan a clinical diagnostic system
based on the Company's ORIGEN technology. Under this agreement, Eisai has
paid $8 million to IGEN as license fees and an additional $2.75 million as an
advance royalty payment. During 1997, Eisai launched an ORIGEN-based product
under the trade name Picolumi, which consists of an immunodiagnostic
instrument and certain assays for use in Japan in the market regulated by the
Japanese Ministry of Health and Welfare. Eisai currently markets three cancer
tests and one test for HTLV and is developing additional tests. The Company
receives royalties from Eisai's sales.
For the three fiscal years ended March 31, 1997, 1998 and 1999, revenue from
corporate collaborators, which is represented as product-based royalty income,
license fees and contract revenue, totaled $9.6 million (60%), $7.8 million
(58%), and $9.9 million (67%), respectively.
RESEARCH AGREEMENTS
In 1993, the Company established HyperGen, a joint venture partnership, with
Hyperion Catalysis International ("Hyperion") to develop and commercialize
biomedical products utilizing advanced materials such as Hyperion's proprietary
Graphite Fibrils nanotubes. Hyperion, a privately-held company based in
Cambridge, Massachusetts, is engaged in the development and manufacture of
Graphite Fibrils, an innovative carbon-based nanofiber. IGEN licensed the
exclusive right to use products developed by HyperGen for diagnostic
applications. The Company contributed cash of $3 million for its initial 50%
interest in HyperGen and made additional cumulative payments of $2 million based
on the attainment of certain research milestones. In December 1994, the Company
acquired the remaining 50% interest in HyperGen for $3 million. IGEN assumed
operating control of HyperGen and consolidated HyperGen's research and
development programs into the Company's internal programs.
Acquisition of the HyperGen rights to Graphite Fibrils enabled IGEN to commence
the development of proprietary products to complement its business in the
medical and life science marketplace. One product under investigation by IGEN is
a filter comprised of Graphite Fibrils that could be used as a disposable
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electrode for ECL measurements for ORIGEN-based products. The Company's Chief
Executive Officer, Samuel Wohlstadter, is Chief Executive Officer and a
shareholder of Hyperion.
During November 1995, the Company formed a joint venture for the development and
commercialization of advanced diagnostics products utilizing a proprietary
combination of multi-array technology together with the Company's ORIGEN
technology. Products based on these technologies would be used for high
throughput, multiparameter analysis for DNA sequencing, clinical chemistry and
immunodiagnostics. The joint venture is named Meso Scale Diagnostics, LLC
("MSD"), and was formed together with Meso Scale Technologies, LLC ("MST"), a
company based in Maryland. MST is a technology-based company established and
operated by Jacob Wohlstadter, the son of Samuel J. Wohlstadter, the Chief
Executive Officer of the Company. Nadine Wohlstadter, a member of MST, is the
spouse of Samuel J. Wohlstadter. The Company has agreed to provide initial
capital contributions to MSD of $5 million over time in exchange for its
ownership interest and in addition, it has agreed to fund the organizational and
certain ongoing (non-research) expenses of MSD. Furthermore, at the request of
MSD, IGEN will make available to MSD such personnel as are reasonably necessary
to permit MSD to conduct its research (such time spent by IGEN personnel would
be credited to IGEN's capital contributions). The Company will also participate
in a collaborative research program under which no funds have been expended.
MSD's research programs to develop products will be based on multi-array
diagnostic techniques and the ability to control and adapt surface chemistry
reactions on a microscopic level. The process may generate thousands of
reactions on a single chip with diagnostic results presented on an array and
read using electrochemiluminescence. The multiple results would represent an
advance in diagnostic testing enabling researchers and clinicians to explore
complex information rapidly and cost-effectively.
PATENTS AND OTHER PROPRIETARY RIGHTS
IGEN pursues a policy of seeking patent protection to preserve its proprietary
technology and its right to capitalize on the results of its research and
development activities and, to the extent it may be necessary or advisable, to
exclude others from appropriating its proprietary technology. IGEN also relies
upon trade secrets, know-how, continuing technological innovations and licensing
opportunities to develop and maintain its competitive position. The Company
prosecutes and defends its intellectual property, including its patents, trade
secrets and know-how. The Company regularly searches for third-party patents in
its fields of endeavor, both to shape its own patent strategy as effectively as
possible and to identify licensing opportunities.
IGEN owns 40 issued U.S. patents and has 45 pending U.S. applications in the
diagnostics field. Worldwide, the Company owns 85 additional issued patents and
has more than 147 pending patent applications covering the same technology.
These patents and patent applications cover various aspects of IGEN's ORIGEN
technology and products, and the methods for their production and use. IGEN
patents will not begin to expire until 2005; core ORIGEN patents will extend
through 2015. The Company continues to protect its technology with new patent
filings which could further extend its patent coverage.
The patent positions of diagnostic firms, including the Company, are highly
uncertain and involve complex legal and factual questions. The Company may have
to participate in interference proceedings declared by the U.S. Patent and
Trademark Office to determine priority of invention, which could result in
substantial cost to the Company even if the eventual outcome is favorable to the
Company.
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Consequently, the Company does not know whether its applications will result in
issued patents or whether its patents will provide significant proprietary
protection or will be circumvented or invalidated.
A number of healthcare and information technology companies and research and
academic institutions have filed patent applications or received patents in the
diagnostic field. Some of these applications or patents may be competitive with
the Company's issued patents or pending patent applications or conflict in
certain respects with claims made in the Company's patents or patent
applications or the Company's ability to practice the technology covered
thereby. Such conflicts could result in a significant reduction of the Company's
ability to practice the inventions covered by its patents and pending patent
applications. In addition, if patents containing competitive or conflicting
claims are issued to others and such claims are ultimately determined to be
valid, there can be no assurance that the Company will be able to obtain
licenses to these patents at a reasonable cost or be able to develop or obtain
alternative technology.
In June 1998, a subsidiary of Ares - Serono filed a patent infringement claim
against IGEN, Roche and Organon Teknika in U.S. District Court in Delaware. This
action claims that a patent for "A Method Assay Employing a Magnetic Electrode"
is being infringed by IGEN. The Company does not believe it infringed on the
Serono patent and intends to vigorously defend against this claim.
The Company filed an opposition in the European Patent Office in 1995 to a
patent (EP 0 285 05781) owned by Enzo Biochem, Inc. This patent covers labeled
oligonucleotides useful in DNA probe assays. Separate oppositions have been
lodged by Roche and Organon Teknika. The Company is vigorously opposing this
patent. Since the opposition is still in an early stage, it is not possible to
predict the outcome or the effect, if any, on the Company's intellectual
property or products.
GOVERNMENT REGULATION
The Company's research and development activities and the future manufacturing
and marketing of products by the Company are subject to regulation by numerous
governmental authorities in the United States and other countries. In the United
States, clinical diagnostic devices are subject to rigorous U.S. Food and Drug
Administration ("FDA") regulation. The Federal Food, Drug and Cosmetic Act and
the Public Health Service Act govern the testing, manufacture, safety, efficacy,
labeling, storage, record keeping, approval, advertising and promotion of the
Company's clinical products. In addition to FDA regulations, the Company is
subject to other federal and state regulations such as the Occupational Safety
and Health Act and the Environmental Protection Act. Product development and
approval within this regulatory framework may take a number of years and
involves the expenditure of substantial resources. In addition, there can be no
assurance that this regulatory framework will not change or that additional
regulation will not arise at any stage of the Company's product development,
which may affect approval of or delay an application or require additional
expenditures by the Company.
The Company's regulatory strategy is to pursue development and marketing
approval of its products worldwide, either independently or through corporate
collaborators. The Company intends to seek input from the regulatory authorities
at each stage of the clinical process to facilitate appropriate and timely
clinical development. The clinical development of certain products may be the
responsibility of the Company's collaborators.
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CLINICAL DIAGNOSTIC SYSTEMS
The manufacture, distribution and sale in the United States of the Company's
products for clinical diagnostic purposes will require prior authorization by
the FDA. The FDA and similar agencies in foreign countries have promulgated
substantial regulations that apply to the testing, marketing, export and
manufacturing of diagnostic products. To obtain FDA approval of a new product
for diagnostic purposes, the Company or its collaborators will in most cases be
required to submit proof of the safety and efficacy of the product, or its
"substantial equivalence" to previously marketed products. Such proof typically
entails clinical and laboratory tests. The testing, preparation of necessary
applications and processing of those applications by the FDA is expensive and
time consuming. Significant difficulties or costs may be encountered by the
Company in its efforts to obtain FDA approvals that could delay or preclude the
Company from marketing its products for diagnostic purposes. Furthermore, there
can be no assurance that the FDA will not request the development of additional
data following the original submission. With respect to patented products or
technologies, delays imposed by the governmental approval process may materially
reduce the period during which the Company or its collaborators will have the
exclusive right to exploit those products or technologies.
The Company's and its collaborative partners' diagnostic products are regulated
as medical devices. The Roche Elecsys clinical diagnostic product has received
FDA approval. Prior to entering commercial distribution, all medical devices
must undergo FDA review under one of two basic review procedures depending on
the type of assay: a Section 510(k) pre-market notification ("510(k)") or a
pre-market approval application ("PMA"). 510(k) notification is generally a
relatively simple filing submitted to demonstrate that the device in question is
"substantially equivalent" to another legally marketed device and includes tests
for therapeutic drugs and hormones. Approval under this procedure may be granted
within 90 days if the product qualifies, but generally takes longer, and may
require clinical testing. When the product does not qualify for approval under
the 510(k) procedure, the manufacturer must file a PMA to show that the product
is safe and efficacious, based on extensive clinical testing among several
diverse testing sites and population groups, and shows acceptable sensitivity
and specificity. This procedure requires much more extensive pre-filing testing
than does the 510(k) procedure and involves a significantly longer FDA review
after the date of filing. In responding to a PMA, the FDA may grant marketing
approval, may request additional information, may set restrictive limits on
claims for use or may deny the application altogether.
After product approvals have been received, they may still be withdrawn if
compliance with regulatory standards is not maintained or if problems occur
after the product reaches the market. The FDA may require surveillance programs
to monitor the effect of products which have been commercialized, and has the
power to prevent or limit further marketing of the products based on the results
of these post-marketing programs. In addition to obtaining FDA approval for each
product, under the PMA guidelines, the Company must seek FDA approval of the
manufacturing facilities and procedures. The FDA will also inspect diagnostic
companies on a routine basis for regulatory compliance with its Good
Manufacturing Practices ("GMP").
The Company's products for the physician's office market will be affected by the
Clinical Laboratory Improvement Amendments of 1988 ("CLIA"), which is intended
to insure the quality and reliability of medical testing and may have the effect
of discouraging, or increasing the cost of, testing in physicians' offices. The
regulations establish requirements for laboratories in the area of
administration, participation in proficiency testing, patient test management,
quality control, personnel, quality assurance and inspection. Under these
regulations, the specific requirements that a laboratory must meet depend
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upon the complexity of the tests performed by the laboratory. Laboratory tests
are categorized as either waived tests, tests of moderate complexity or tests of
high complexity. Laboratories that perform either moderate or high complexity
tests must meet standards in all areas, with the major difference in
requirements between moderate and high complexity testing concerning quality
control and personnel standards. Quality control standards for moderate
complexity testing are being implemented in stages. Personnel standards for high
complexity testing are more rigorous then those for moderate complexity testing.
In general, personnel conducting high complexity testing will need more
education and experience than those doing moderate complexity testing. Under the
CLIA regulations, all laboratories performing moderately complex or highly
complex tests will be required to obtain either a registration certificate or
certificate of accreditation from the Healthcare Financing Administration
("HCFA").
Because the regulations' interpretation is uncertain, it is possible that
certain of the Company's products may be categorized as tests of high
complexity, in which case the Company's penetration of the point-of-care market
would be reduced since not all laboratories would meet the standards required to
conduct such tests. The Company understands that laboratories, including
physician office laboratories, will be evaluating the requirements of CLIA in
determining whether to perform certain types of moderate and high complexity
diagnostic tests. The Company believes that the sale of its products will not be
adversely affect by CLIA. However, no assurance can be given that the statute
and its implementing regulations will not have a material adverse impact on the
Company and its ability to market and sell any products that it develops.
Although the Company believes that it will be able to comply with all applicable
regulations regarding the manufacture and sale of diagnostic devices, such
regulations are always subject to change and depend heavily on administrative
interpretations. There can be no assurance that future changes in regulations or
interpretations made by the HHS, FDA, HCFA or other regulatory bodies, with
possible retroactive effect, will not adversely affect the Company. In addition
to the foregoing, the Company is subject to numerous federal, state and local
laws and regulations relating to such matters as safe working conditions,
laboratory and manufacturing practices, environmental, fire hazard control, and
disposal of hazardous or potentially hazardous substances. To date, compliance
with these laws and regulations has not had a material effect on the Company's
financial results, capital requirements or competitive position, and the Company
has no plans for material capital expenditures relating to such matters.
However, there can be no assurance that it will not be required to incur
significant costs to comply with such laws and regulations in the future, or
that such laws or regulations will not have a material adverse effect upon the
Company's ability to do business.
Sales of the Company's products outside the United States are also subject to
extensive regulatory requirements, which vary widely from country to country.
The time required to obtain such approval may be longer or shorter than that
required for FDA approval.
RESEARCH PRODUCTS
The Company's products that are being sold for research use only, including the
M-SERIES High Throughput Screening System, must be properly labeled as such, as
required by the FDA, but do not generally require FDA approval prior to
marketing. The FDA has begun to impose new distribution requirements and
procedures on companies selling research-only products, such as the requirement
that the seller receive specified certifications from its customers as to the
customers' intended use of the product. The Company expects that the FDA will
develop additional restrictions of this nature. The
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Company is unable at this time to predict the form these restrictions may take,
their likely magnitude or their ultimate impact on the Company or its sales.
ENVIRONMENTAL REGULATION
Due to the nature of its current and proposed research, development and
manufacturing processes, the Company is subject to stringent federal, state and
local laws, rules, regulations and policies governing the use, generation,
manufacture, storage, air emission, effluent discharge, handling and disposal of
certain materials and wastes. Although the Company believes that it has complied
with these laws and regulations in all material respects and has not been
required to take any action to correct any noncompliance, there can be no
assurance that the Company will not be required to incur significant costs to
comply with environmental and health and safety regulations as it expands its
production operations.
REIMBURSEMENT
Third party payors, such as governmental programs and private insurance plans,
can indirectly affect the pricing or the relative attractiveness of the
Company's products by regulating the maximum amount of reimbursement they will
provide for diagnostic testing services. In recent years, healthcare costs have
risen substantially, and third-party payors have come under increasing pressure
to reduce such costs. In this regard, the Federal government, in an effort to
reduce healthcare costs, may take actions which may involve reductions in
reimbursement rates. If the reimbursement amounts for diagnostic testing
services are decreased in the future, it may decrease the amount which
physicians, clinical laboratories and hospitals are able to charge patients for
such services and consequently the price the Company can charge for its
products.
COMPETITION
Competition in the diagnostic industry is intense, and a small number of large
and well established companies are major participants. In view of the nature of
the industry, the Company has elected to rely on alliances with established
companies to exploit fully the advantages of its diagnostic systems. There can
be no assurance, however, that IGEN's corporate collaborators will be successful
in commercializing the ORIGEN technology. Furthermore, academic institutions,
government agencies and other public and private organizations conducting
research may develop potentially competing products or technologies and may
establish collaborative arrangements with competitors of the Company.
The Company's competition will be determined in part by the potential
applications for which the Company's products are developed and ultimately
approved by regulatory authorities. For certain of the Company's future
products, an important factor in competition may be the timing of market
introduction of its own or competing products. Accordingly, the relative speed
with which IGEN or its corporate collaborators can develop products, complete
the clinical trials and approval processes and supply commercial quantities of
the products to the market are expected to be important competitive factors. The
Company expects that competition with products approved for sale will be based,
among other things, on product efficacy, safety, reliability, availability,
price and patent position.
Many of the Company's existing or potential competitors have substantially
greater financial, technical and human resources than the Company and may be
better equipped to develop, manufacture and market
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products. These companies may develop and introduce products and processes
competitive with or superior to those of the Company.
The Company's competitive position also depends upon its ability to attract and
retain qualified personnel, obtain patent protection or otherwise develop
proprietary products or processes and secure sufficient capital resources for
the often substantial period between technological conception and commercial
sales.
MANUFACTURING
The Company's current commercial manufacturing operations consist of the
manufacture of the M-SERIES High Throughput Screening System and the ORIGEN
Detection System and related reagents and cell culture research biologicals as
well as quality assurance processes. IGEN operates a qualified GMP facility. The
Company uses a variety of suppliers and believes that it does not depend on any
single-source supplier that it cannot replace in the ordinary course of
business. The Company has not yet introduced clinical diagnostic products.
Initial clinical diagnostic products, based on the Company's ORIGEN technology,
are being manufactured by the Company's corporate collaborators. Although
additional future products may be manufactured by the Company, it has not yet
developed plans for establishing manufacturing operations for these products.
SALES AND MARKETING
IGEN markets the M-SERIES High Throughput Screening System and the ORIGEN
Detection System, together with related reagents and services, directly to the
life science research market. In conjunction with the U.S. and European launch
of the M-SERIES system, the Company has expanded its direct sales force,
including the addition of application specialists and in-house technical
services personnel. The Company continues to develop marketing plans for Japan.
Substantial sales and marketing of products based on the Company's ORIGEN
technology is conducted by corporate collaborators. See "-- Collaboration and
License Agreements." The ORIGEN cell culture products are sold directly and
through distributors.
HUMAN RESOURCES
As of May 31, 1999, IGEN employed 158 individuals full-time, of whom 105 were
engaged in research, product development, manufacturing and operations support,
36 in marketing, sales and applications support and 17 in general
administration. Of the Company's employees, 53 have Ph.D. degrees. A significant
number of the Company's management and professional employees have had prior
experience with pharmaceutical, biotechnology, diagnostic or medical products,
computer software or electronics companies. None of the Company's employees is
covered by collective bargaining agreements, and management considers relations
with its employees to be good.
The Company's ability to maintain its competitive position will depend, in part,
upon its continued ability to attract and retain qualified scientific and
managerial personnel. Competition for such personnel is intense.
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RISK FACTORS
DEPENDENCE ON THE EFFORTS OF LICENSEES AND COLLABORATORS
IGEN's business depends, in part, on the efforts of companies to which it has
licensed its technology. IGEN has licensed its technology to Organon Teknika
B.V., Eisai Co., Ltd., and Roche Diagnostics for selected markets and uses. If
these companies do not effectively develop and market products based on this
technology, IGEN's business would be adversely affected.
IGEN's license agreements allow these companies to develop products using IGEN's
technology. The licenses also authorize them to manufacture and sell those
products in selected markets.
In return for the right to use IGEN's technology, each of these companies must
pay royalties to IGEN based on revenues from products using the technology. Each
company is currently selling products based on IGEN's technology and making
royalty payments. These royalties are a significant part of IGEN's overall
revenue, accounting for 63% of revenue in fiscal year 1999. IGEN believes that
licensees have economic incentives to continue marketing products using this
technology, but IGEN cannot predict future royalty income. Future royalties will
depend on a variety of factors that are outside IGEN's control. For example, the
amount of royalties IGEN receives will depend on how diligently licensees market
products incorporating the technology. IGEN has a lawsuit against Roche, in part
because it believes Roche has not calculated and paid royalties properly and has
not marketed the technology as diligently as the license agreement requires.
In the future, IGEN expects to enter into additional license agreements or other
collaborative arrangements to develop and market products using IGEN technology.
Future royalty income will depend, in part, on whether IGEN can negotiate
suitable arrangements with other companies and whether the products using IGEN's
technology succeed commercially.
LITIGATION AGAINST ROCHE AND HITACHI
IGEN is currently involved, directly and indirectly, in two separate lawsuits
with its licensee Roche. Roche is the largest licensee of IGEN's technology in
terms of royalty income. IGEN cannot predict whether it will succeed in this
litigation.
IGEN is currently suing Roche in Maryland federal court about disputes over a
license agreement between the two companies. This license agreement gives Roche
the exclusive right to manufacture, market and sell diagnostic equipment, and
related assays, using IGEN's patented ORIGEN technology, to central hospital
laboratories and clinical reference laboratories. The license restricts Roche's
rights in the Japanese clinical diagnostic market.
In the lawsuit, IGEN claims that Roche has not performed a variety of its
obligations under the license agreement. Allegations include the following:
- Roche has not developed and commercialized ORIGEN technology
according to an agreed-upon timetable.
- Roche has not diligently marketed the licensed technology.
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- Roche continues to market products on which it does not have to
pay royalties, even though the license agreement required it to
phase out these products.
- Roche has marketed and sold products to customers that are not
permitted under the license.
- Roche has disregarded certain confidentiality obligations that
apply to the ORIGEN technology.
- Roche has not maintained its corporate records in a way that would
allow it to accurately calculate the royalties it owes to IGEN.
- Roche has not properly computed royalties and has underpaid
royalties to IGEN.
Based on the violations by Roche of the license agreement, IGEN asked the court
to do three principal things:
- Award monetary damages to compensate IGEN for Roche's failure to
perform its contractual obligations.
- Prohibit Roche from violating the license agreement in the future.
- Determine that IGEN is entitled to terminate the agreement with
Roche because of Roche's material breaches.
During 1998, IGEN asked the court to issue a preliminary injunction because it
believed Roche was selling outside of its authorized markets. IGEN asked the
court to:
- Prohibit Roche from selling products using ORIGEN technology to
physicians' offices and physicians' office laboratories which are
not within Roche's licensed field.
- Direct Roche to transfer its current unauthorized customers to
IGEN for future orders of reagents.
- Direct Roche to place all income from its unauthorized sales in
an escrow account until completion of the litigation.
The court granted IGEN's motion in July 1998 and issued a preliminary injunction
in October 1998. Roche has appealed the decision to the Fourth Circuit Court of
Appeals. This appeal is currently pending.
In December 1998, Roche filed a counterclaim with the court against IGEN. In
that counterclaim, Roche asserted complaints for fraud, breach of contract,
tortuous interference with business relations, unjust enrichment/equitable
recoupment and contract reformation. IGEN believes that Roche's claims are
unfounded. In March 1999, IGEN asked the court to dismiss Roche's claims for
fraud, tortious interference with business relations, unjust
enrichment/equitable recoupment and contract reformation. IGEN also asked the
court to dismiss a small portion of Roche's breach of contract claim and to
dismiss Roche's request for damages and injunctive relief. After receiving
IGEN's motion to dismiss, Roche dropped its complaint for contract reformation
and part of its tortious interference complaint. In June 1999, the court
dismissed Roche's claims for fraud, tortious interference, and unjust
enrichment/equitable recoupment and refused Roche's request for punitive damages
and injunctive relief. Roche's breach of contract counterclaim remains
oustanding.
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In addition to the Maryland lawsuit, IGEN is suing Roche's Japanese
manufacturer, Hitachi Ltd. in Japan. Hitachi manufactures diagnostic equipment
based on ORIGEN technology for Roche. IGEN believes Hitachi's actions in Japan
violate certain rights IGEN originally granted to Eisai to develop, manufacture
and sell products using ORIGEN technology to the Japanese clinical diagnostic
market. IGEN asked the Japanese court for the following actions to remedy
Hitachi's violations:
- Prohibit Hitachi from manufacturing, using or selling, in Japan,
the Elecsys 2010 Instrument (Roche's immunoassay instrument that
is based on ORIGEN technology in Japan).
- Order Hitachi to destroy all of the Elecsys instruments in
Hitachi's possession.
IGEN is vigorously pursuing these lawsuits against Roche and Hitachi and it
believes that the lawsuits are well-founded. It cannot be certain, though, that
IGEN will win in either lawsuit. The lawsuits may present certain risks to
IGEN's current and future business.
With respect to IGEN's current business, IGEN does not believe that the lawsuit
against Roche is affecting Roche's sales of products incorporating ORIGEN
technology or the royalties IGEN receives as a result of those sales. IGEN has
voluntarily agreed not to terminate the license agreement with Roche until the
court determines that it has that right. Therefore, during the course of this
litigation, Roche has the right to continue selling products based on ORIGEN
technology to central hospital laboratories and to clinical reference
laboratories, and IGEN expects to continue receiving royalties, as calculated by
Roche, for those sales.
With respect to IGEN's future prospects, the lawsuit against Roche could affect
IGEN's business in a variety of ways. First, if the court determines that Roche
has not miscalculated or underpaid royalties, the future royalty revenue from
Roche's Elecsys products could be materially less than expected amounts.
Although IGEN does not believe its own product development efforts would suffer
directly, there would be less money available, all other things being equal, to
devote to product development. Second, although IGEN does not believe that
Roche's sales of licensed products, or the resulting royalty revenue, would
suffer if IGEN lost the lawsuit, this is not certain. And, finally, if the court
decides that IGEN may terminate the license agreement with Roche and IGEN
chooses to do so, there would be risks in connection with the termination. If
IGEN were to terminate the agreement, royalty revenues could suffer temporarily
until IGEN found a suitable replacement for Roche. IGEN's overall income may
significantly decrease. Furthermore, at this time, IGEN cannot be sure that it
would be able to find a suitable replacement.
Like the Roche litigation, the lawsuit against Hitachi also presents business
risks. If IGEN wins the lawsuit against Hitachi, Roche would need to find a new
manufacturer for equipment based on ORIGEN technology or make arrangements for
Hitachi to manufacture the equipment outside of Japan. As a result, IGEN royalty
income could suffer if Roche experiences supply problems. On the other hand, if
IGEN loses the lawsuit, it does not foresee any direct adverse effects. IGEN
does not believe that royalty income would suffer if it lost the Hitachi
lawsuit. Hitachi would be able to continue manufacturing equipment using IGEN
technology for Roche in Japan and IGEN would still be entitled to royalties
based on the sales of the equipment.
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COMPETING AGAINST MORE ESTABLISHED COMPANIES AND INSTITUTIONS
IGEN is a relatively young company in a highly competitive industry. It competes
against established diagnostic companies and with research and academic
institutions, and IGEN expects this competition to intensify. Many of these
companies and institutions have one or more competitive advantages: more money
to invest; greater technical expertise in developing and marketing products; a
larger, more experienced workforce; and more experience in obtaining regulatory
approval for diagnostic products.
NEED FOR ADDITIONAL CAPITAL
IGEN may need to raise substantial amounts of money to fund a variety of future
activities, including the following:
- Development efforts: IGEN will have to spend a substantial amount
of time and effort for research and development to successfully
develop its technology.
- Regulatory approval: IGEN will need to obtain regulatory approval
for certain of its products. It plans to get approval by showing
that these products are "substantially equivalent" to products
that have already been approved. If IGEN does not succeed, it will
have to conduct extensive clinical trials at substantial expense
to gain regulatory approval. Costs for obtaining regulatory
approval will depend on the method used to gain regulatory
approval and the amount of time and effort that must be invested.
- Patent protection: IGEN needs to protect its technology by filing
and prosecuting patent applications. It will need to enforce
patent rights against infringement by competitors. IGEN's patent
related expenses will depend on how many applications IGEN files,
the amount and strength of opposition to filings, and the cost of
enforcing intellectual property rights against competitors who
infringe IGEN's patents.
- Technological innovation: IGEN will need to respond to innovations
by our competitors. For example, it may have to invest more money
in research and development to respond to improvements in
competing technologies.
- Market changes: IGEN will need to respond appropriately to changes
in the market. For example, it may have to spend more to keep
qualified employees if competition increases for scientists.
- Licensing situation: IGEN may need to make new arrangements for
marketing its technology. In particular, if IGEN succeeds in its
lawsuit against Roche, it may have to look for a company to
replace Roche in marketing products to central hospital
laboratories and to clinical research laboratories. If IGEN is not
able to find a suitable replacement, it may have to market the
products directly, which would require additional investments to
expand manufacturing and marketing capabilities.
- Manufacturing: Currently, IGEN does not have the ability to
manufacture certain products commercially. It may look for a
company to manufacture its products. If not, or if it does not
find an appropriate manufacturer, IGEN may need to invest
substantial amounts to build or buy its own facilities.
- Sales and marketing: Currently, IGEN does not have multiple sales
teams to market different products to different markets. As with
manufacturing, it
21
<PAGE>
may look for a company to provide sales, marketing and
distribution services for certain products. Alternatively, IGEN
may need to build its own sales and distribution force.
IGEN has a variety of funding options, but it cannot be certain that it will
have access to enough funds to successfully develop the business. IGEN expects
to need additional capital in the future, which it could raise by issuing
additional debt securities or selling additional common or preferred stock,
which could dilute the holdings of existing stockholders. If IGEN is unable to
raise additional capital, it may have to scale back, or even eliminate, some
programs. Alternatively, IGEN may have to consider arrangements with other
companies, such as granting licenses or entering into joint ventures. These
arrangements could require that IGEN give up some rights to technology or
products.
NEED FOR QUALIFIED STAFF
IGEN needs to hire additional staff and retain existing staff, which is
difficult in today's competitive marketplace. Because IGEN is a technology
company, it depends heavily on scientists to develop products and to build a
successful business. Research and development efforts could suffer if IGEN were
not able to hire and retain enough qualified scientists. IGEN cannot be sure
that it will succeed in its hiring and retention efforts. There is competition
against other technology companies and research and academic institutions for
experienced scientists. Many of these companies and institutions have greater
resources than IGEN.
In addition to scientists, IGEN will also need to hire managers as the business
grows. IGEN will need managers who are able to address the need for regulatory,
manufacturing and marketing capabilities. If IGEN is not able to hire managers
with these skills, or develop expertise in these areas, its business prospects
could suffer.
IGEN also relies on outside consultants and advisors to create research and
development strategies. Most consultants and advisors work for other companies.
Their other commitments could make them unavailable to work for IGEN when needed
in the future. This could hurt IGEN's ability to formulate effective research
and development strategies.
FDA APPROVAL REQUIRED FOR CLINICAL PRODUCTS
The Company's products that are being sold for research use only, including the
M-SERIES High Throughput Screening System, must be properly labeled as such, as
required by the FDA, but do not generally require FDA approval prior to
marketing. IGEN must obtain FDA approval before it can market clinical
diagnostic products. The FDA regulates many areas in which IGEN conducts
research and in which it develops, produces and markets products. In the United
States, IGEN (or the companies with whom it works) will need to submit data from
clinical trials demonstrating that its clinical diagnostic systems are
substantially equivalent to diagnostic systems that have already been approved.
Until the FDA determines that an ORIGEN-based system is substantially
equivalent, IGEN cannot sell that system for clinical use in the United States.
Typically, the FDA review process is a 90-day process, but the FDA's review
could take longer. In addition, IGEN cannot be sure that it will be able to
demonstrate substantial equivalence for present or future diagnostic systems. If
IGEN does not successfully demonstrate substantial equivalence, it will have to
conduct extensive clinical testing of these products. Extensive testing could
involve substantial additional costs and might delay bringing clinical
diagnostic products to market.
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<PAGE>
REGULATION OF PRODUCTS AND MANUFACTURING
It may cost a substantial amount to comply with the regulations of the FDA and
other governmental agencies. Government agencies, such as the FDA and the EPA,
regulate manufacturers of diagnostic products and the manufacturing process. The
costs of complying with governmental regulations and with any restrictions that
might be imposed could have a significant impact on IGEN's business. Whether
IGEN manufactures products or uses another company, the FDA will continually
review and periodically inspect the manufacturing process. If the FDA discovered
a problem with IGEN's products, the manufacturing process or the manufacturing
facility, it could place restrictions on these products and on the manufacturer.
For example, the FDA could require IGEN to recall, or even to totally withdraw,
a product from the market. In addition to FDA regulations, the process of
manufacturing products will be subject to a variety of environmental and safety
laws and regulations, including laws and regulations governing the use and
disposal of hazardous materials.
LACK OF MANUFACTURING AND MARKETING EXPERIENCE
IGEN lacks experience in large-scale manufacturing of diagnostic equipment and
it is not currently equipped to manufacture all products. There are two options
to address this problem. IGEN could expand the internal ability to manufacture
products in compliance with FDA regulations or IGEN could contract with a third
party to manufacture products for it. If IGEN cannot develop its own
manufacturing capacity or find a suitable manufacturer in a timely manner, it
will be delayed in introducing products to the market. A delay could put IGEN at
a competitive disadvantage and could harm the financial condition of IGEN.
IGEN will also need to develop greater selling, marketing and distribution
capabilities. To market clinical diagnostic products directly, IGEN would need
to develop a substantial sales force with technical expertise. It would also
need to establish a distribution system to support the sales force.
Alternatively, IGEN could license or contract with another company to provide
sales and distribution services for products, in much the same way as was done
with Roche, Eisai and Organon Teknika. IGEN cannot be sure, however, that it
will be able to develop its own sales and distribution force or that it will be
able to find a suitable company to fill that role for it.
DEPENDENCE ON PATENTS
IGEN's business depends heavily on patents, which will expire in time and may be
challenged or circumvented by competitors. IGEN's strategy is to file patent
applications covering its technology and products. Patents allow IGEN to prevent
others, for a time, from using IGEN's inventions to compete against it. IGEN's
success or failure will depend, in part, on its ability to obtain and maintain
adequate patent protection for the ORIGEN technology.
IGEN has over 147 patent applications pending in the United States and abroad.
It cannot be sure, though, that any patents will actually be issued as a result
of these applications. In the United States, IGEN owns or co-owns 40 patents
providing exclusive rights in the diagnostic market; in other parts of the world
IGEN owns or co-owns 45 patents in its field. . IGEN patents will not begin to
expire until 2005; core ORIGEN patents will extend through 2015. IGEN will
continue to file new patent applications which could extend patent coverage of
ORIGEN technology beyond that time.
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<PAGE>
IGEN also cannot be certain that current patents or future patents will
adequately protect its technology from use by competition. The breadth of claims
in medical patents depends on complex factual issues and legal standards.
Because there is no consistent policy governing the scope of these claims,
patent protection is uncertain. Companies may, for example, challenge and
invalidate patents or circumvent valid claims in patents, all of which could
make it necessary for IGEN to defend its patents in litigation. Litigation over
patents could harm IGEN's business in at least three ways. First, litigation
costs can be high, which could drain IGEN's financial resources. Second,
litigation over IGEN's patents could discourage other companies from working
with IGEN to develop and market new products. Third, if IGEN loses some patent
protection as a result of litigation, its competitive advantage could be eroded.
IGEN's success or failure will also depend, in part, on the patent rights of
others. IGEN licenses technology from other companies and academic institutions.
Because these patents are necessary to its business, IGEN must be certain that
it complies with these license agreements. IGEN's business could be harmed if it
breached these agreements and lost the rights to use this patented technology.
IGEN must also be sure that it does not infringe the patent rights of
competitors. If IGEN did infringe, there are several possibilities--IGEN may
have to alter its products or processes; it may have to obtain a license from
the patent holder; or it may be forced to abandon development work that relates
to these products. IGEN cannot be sure that it would be able to alter products
or processes or that it could obtain a license at a reasonable cost. The
business could be damaged if IGEN is unable to make necessary alterations or
obtain a necessary license. In addition, IGEN may need to litigate the scope and
validity of patents held by others. Litigation could be a substantial cost for
IGEN.
Laboratories Serono, S.A., a subsidiary of Ares-Serono, filed a patent
infringement claim against IGEN and against the licensees, Roche and Organon
Teknika, in June 1998. It claims that IGEN is violating its patent for "A Method
Assay Employing a Magnetic Electrode." IGEN is in the early stages of responding
to this claim, but does not believe that it or its licenses have been or are now
infringing the patent. IGEN will continue to vigorously defend this claim.
In an effort to defend its technology against infringement by others, IGEN is
opposing a European patent owned by Enzo Biochem, Inc. Licensees Roche and
Organon Teknika have also filed oppositions to the Enzo Biochem patent. The
disputed patent gives Enzo Biochem exclusive rights to labeled oligonucleotides
which are useful in DNA probe assays. IGEN is vigorously opposing Enzo Biochem's
patent. Because it is at an early stage in the process, IGEN cannot determine
yet what impact, if any, the Enzo Biochem patent will have on its business.
While IGEN relies heavily on patents to protect its technology, it also enters
into confidentiality agreements with licensees, employees and consultants. These
agreements prohibit them from disclosing IGEN trade secrets and other
confidential information. Despite these agreements, IGEN cannot be sure that the
information shared with others will remain confidential. It also cannot be
certain that it would have sufficient legal remedies to correct or compensate
for unauthorized disclosures. Furthermore, IGEN's confidentiality agreements do
not protect it against the possibility that competitors may make similar,
independent discoveries.
RESTRICTIONS ON PAYMENTS FOR PRODUCTS
Third-party payors, such as governments, health maintenance organizations and
private insurers, are restricting payments for health care. These restrictions
may decrease demand for IGEN's clinical diagnostic products and the price it can
charge. In many foreign markets, the government directly sets
24
<PAGE>
the prices that diagnostic companies may charge. In the United States, IGEN
believes that federal and state lawmakers will continue to propose similar
governmental controls. Increasingly, Medicaid and other third-party payors are
challenging the prices charged for medical services, including clinical
diagnostic tests. They are also attempting to contain costs by limiting coverage
and the reimbursement level of clinical diagnostic tests and other health care
products. IGEN cannot be certain that insurers will cover clinical diagnostic
tests in the future. Without adequate coverage and reimbursement, consumer
demand for diagnostic tests will decrease. Decreased demand would likely cause
IGEN sales of clinical diagnostic products, and sales by its licensees, to fall
because fewer tests would be done or prices would be lowered, or both. Reduced
sales by IGEN or its licensees would hurt IGEN's business and its business
prospects.
YEAR 2000 POTENTIAL ISSUES
Many of the world's computer systems currently record years in a two-digit
format. Such computer systems will be unable to interpret properly dates beyond
the year 1999 which could lead to business disruptions in the U.S. and
internationally ("Year 2000" issues).
IGEN has reviewed its business, financial and accounting systems for Year 2000
issues. IGEN believes that installation of new or upgraded software to address
any Year 2000 issues can be done on time. Upgrading software is not expected to
create disruptions, malfunctions or prevent IGEN from operating its business.
The Company is assessing whether its suppliers and collaborators with Year 2000
issues can comply on time. IGEN cannot be sure that suppliers and collaborators
with Year 2000 issues can comply on time. IGEN does not expect there to be
significant future costs. The failure of suppliers and collaborators for Year
2000 could disrupt IGEN's operations.
Year 2000 compliance has not been, and is not anticipated to be, significant
based on management's best estimates. These costs are based on management's best
estimates of future events including continued availability of resources,
suppliers and collaborators. These estimates may be impacted by future events.
POTENTIAL PRODUCT LIABILITY
IGEN may not be able to adequately insure against risk of product liability. As
IGEN begins marketing products, it may face product liability for claims and
lawsuits by customers. Damages in product liability cases can be very large.
While IGEN has product liability insurance, this coverage is limited.
SIGNIFICANT OWNERSHIP BY MANAGEMENT
IGEN management has significant control over the company through stock
ownership. IGEN's officers and directors, own (or have the right to purchase)
about 36% of IGEN's common stock. IGEN's Chief Executive Officer has ownership
of about 27%. If they act together, the officers and directors have significant
influence over the election of directors and other shareholder actions.
LIMITATION OF STOCKHOLDER RIGHTS
IGEN's governing documents have provisions designed to prevent hostile
takeovers, which may limit the ability of shareholders to approve certain
transactions. According to IGEN's governing documents, stockholders can only act
at annual meetings or at special meetings of stockholders. Stockholders are not
allowed to act by written consent. In addition, stockholders are not allowed to
call for a special meeting.
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<PAGE>
Only IGEN's Board of Directors, the Chairman of the Board, or the President may
convene a special meeting. These provisions may make it difficult for
shareholders to force IGEN to hold special meetings. These provisions may also
limit the ability of stockholders to consider transactions that they may want to
approve such as a hostile takeover of the company. IGEN also has other
provisions which could make it more difficult for there to be a change in
control of the company. IGEN's Board of Directors can issue preferred stock and
can determine the rights of those preferred stockholders. For example, IGEN's
Board could give preferred stockholders one or more votes on issues on which
common stockholders vote. This could have the effect of diluting the voting
rights of common stockholders.
STOCK PRICE MAY FALL
IGEN's common stock currently trades on the Nasdaq National Market. The prices
of publicly traded stock often fluctuates. The price of IGEN stock may rise or
fall dramatically, even though its business performance has not changed. In the
past, the stock price of technology companies has been especially volatile. It
is expected that this will continue to be the case. In addition to these
fluctuations, an investment in IGEN could be affected by a wide variety of
factors that relate to its business. For example, the value IGEN shares could be
affected by new inventions IGEN discovers, innovations by competitors, disputes
over patents or other proprietary rights, publicity, regulations, market
conditions, and fluctuations in performance.
NO CASH DIVIDENDS
Since IGEN was formed, it has never paid cash dividends on its common stock.
There are no plans to pay cash dividends in the foreseeable future.
DILUTION OF AN INVESTMENT
IGEN officers, directors, employees and consultants have options to purchase
common stock. If they exercise their options and purchase common stock, an
investment in the company will be diluted. IGEN currently has preferred
stockholders who have the right to convert their preferred shares to common
stock. An investment would be diluted if these preferred stockholders decide to
convert their shares. An investment could be further diluted if IGEN issues
additional common stock. IGEN may need to issue more common stock in the future
to raise funds for the business.
ITEM 2. PROPERTIES
The Company's principal administrative, marketing, manufacturing and research
and development facility consists of an 84,000 square foot building located in
Gaithersburg, Maryland. The Company took occupancy of this leased facility
during 1995. The lease expires in 2005. The Company believes that its current
facility will be adequate for anticipated expansion needs.
ITEM 3. LEGAL PROCEEDINGS
On September 15, 1997, the Company filed a lawsuit in Maryland against Roche
Diagnostics GmbH (then known as Boehringer Mannheim GmbH or BMG), a German
company, to which the Company has licensed certain rights to develop and
commercialize diagnostic products based on the Company's ORIGEN technology. BMG
was acquired by F. Hoffman LaRoche during 1998, and is referred to herein
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<PAGE>
as Roche. That lawsuit is pending in the Southern Division of the United States
District Court for the District of Maryland. The Company's dispute with Roche
arises out of a 1992 License and Technology Development Agreement (the
"Agreement"), pursuant to which Roche developed and launched its "Elecsys" line
of diagnostic products, which is based on ORIGEN technology. The Company alleges
that Roche has failed to perform certain material obligations under the
Agreement, including development and commercialization of ORIGEN technology
according to the contractual timetable; exploitation of the license to the
extent contemplated by the parties; phase out of certain non-royalty-bearing
product lines; exploitation of ORIGEN technology only within Roche's licensed
fields; proper treatment of intellectual property rights regarding ORIGEN
technology; maintenance of records essential to the computation of royalties;
and proper computation and payment of royalties. In its lawsuit, the Company
seeks damages as well as injunctive and declaratory relief, including a judicial
determination of its entitlement to terminate the Agreement. The Company
voluntarily has agreed not to terminate the Agreement unless and until the Court
determines its entitlement to do so.
During 1998, the Company filed a motion for preliminary injunction in its
Maryland lawsuit against Roche. In that motion, the Company requested that the
court enjoin Roche from marketing, selling, or distributing its Elecsys products
outside of Roche's licensed field of use. The 1992 Agreement granted Roche
rights to develop and commercialize diagnostic systems based on the Company's
ORIGEN technology for use in centralized hospital laboratories and clinical
reference laboratories only. The Company retains the rights to exploit its
ORIGEN technology in all other clinical diagnostic markets. The Company learned
that Roche was marketing Elecsys products outside of its licensed field of use
and therefore asked the court to enjoin Roche from selling outside of its
licensed field and, in particular, to physicians' offices and physicians' office
laboratories. The Company also sought additional relief, including an order
requiring Roche to refer all customers outside of Roche's licensed field to the
Company for future reagent supply needs and to place all revenues derived from
unauthorized sales in escrow pending the outcome of the litigation. The court
granted IGEN's motion in July 1998 and issued a preliminary injunction in
October 1998. Roche has appealed the preliminary injunction.
In December 1998, Roche filed a counterclaim against the Company asserting five
causes of action: fraud, breach of contract, tortious interference with business
relations, unjust enrichment/equitable recoupment, and reformation. The Company
believes that Roche's claims are unfounded. In March 1999, the Company moved to
dismiss Roche's claims for fraud, tortious interference with business relations,
unjust enrichment/equitable recoupment and reformation. The Company also moved
the court to dismiss a portion of Roche's breach of contract claim and to strike
Roche's request for punitive damages and injunctive relief. After being served
with the Company's motion to dismiss, Roche dropped its complaint for contract
reformation and part of its tortious interference claim. In June 1999, the court
dismissed Roche's claims for fraud, tortious interference, and unjust
enrichment/equitable recoupment and struck down Roche's request for punitive
damages and injunctive relief. Roche's breach of contract counterclaim remains
outstanding.
In December 1997, IGEN International K.K.(IGEN K.K."), a Japanese subsidiary of
the Company, filed a lawsuit in Tokyo District Court against Hitachi Ltd.
("Hitachi"). The lawsuit seeks to enjoin Hitachi from infringing IGEN K.K.'s
license registration, (known in Japan as a "senyo-jisshi-ken") to prevent
Hitachi from manufacturing, using or selling the Elecsys 2010 Instrument, which
incorporates IGEN's patented ORIGEN technology, in Japan. Hitachi is the sole
manufacturer for Roche of the Elecsys 2010 immunoassay instrument. Roche is
licensed to market the Elecsys 2010 worldwide, except for Japan, to central
hospital laboratories and clinical reference laboratories. The Company's ORIGEN
technology is
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<PAGE>
licensed in Japan to IGEN K.K. and to Eisai Company, Ltd. The lawsuit requests
injunctive relief against Hitachi.
In June 1998, a subsidiary of Ares - Serono filed a patent infringement claim
against IGEN, Roche and Organon Teknika in U.S. District Court in Delaware. This
action claims that a patent for "A Method Assay Employing a Magnetic Electrode"
is being infringed by IGEN. The Company does not believe it infringed on the
Serono patent and intends to vigorously defend against this claim.
The Company filed an opposition in the European Patent Office in 1995 to a
patent (EP 0 285 05781) owned by Enzo Biochem, Inc. This patent covers labeled
oligonucleotides useful in DNA probe assays. Separate oppositions have been
lodged by Roche and Organon Teknika. The Company is vigorously opposing this
patent. Since the opposition is still in an early stage, it is not possible to
predict the outcome or the effect, if any, on the Company's intellectual
property or products.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
No matter was submitted to a vote of security holders of the Company during the
fourth quarter of the fiscal year covered by this report.
EXECUTIVE OFFICERS OF THE COMPANY
The names and ages of all executive officers of the Company at June 11, 1999 and
their respective positions and offices with the Company are set forth below.
Each officer serves without a set term.
<TABLE>
<CAPTION>
NAME AGE POSITION
---- --- --------
<S> <C> <C>
Samuel J. Wohlstadter 57 Chairman, Chief Executive Officer and Director
Richard J. Massey, Ph.D. 52 President, Chief Operating Officer and Director
Robert Connelly 39 Vice President, Marketing and Sales
George V. Migausky 44 Vice President, Chief Financial Officer and Secretary
</TABLE>
SAMUEL J. WOHLSTADTER is a founder of the Company and has been Chairman of the
Board and Chief Executive Officer since its formation in 1982. Mr. Wohlstadter
has been a venture capitalist for more than 25 years and has experience in
founding, supporting and managing high technology companies, including Amgen
Inc., a biopharmaceutical company, and Applied Biosystems, Inc., a medical and
biological research products company. Mr. Wohlstadter is also Chief Executive
Officer of Hyperion Catalysis International, an advanced materials company,
which he founded in 1981, of Pro-Neuron, Inc., a drug discovery company, which
he founded in 1985, of Proteinix Corporation, a development stage company
organized to conduct research in intracellular metabolic processes, which he
founded in 1988 and of Pro-Virus, Inc., a drug discovery company, which
commenced operations in 1994.
RICHARD J. MASSEY, PH.D. is a founder of the Company, has been President and
Chief Operating Officer of the Company since 1992, a Director of the Company
since 1990 and served as Senior Vice President since 1985. From 1981 until he
joined IGEN in 1983, Dr. Massey was a faculty member in the Microbiology and
Immunology Department at Rush Medical Center in Chicago. Prior to that, he was
Senior Research Scientist at the National Cancer Institute, Frederick Cancer
Research Center.
ROBERT CONNELLY, has been Vice President of Marketing and Sales since 1994, when
he joined the Company. Previously, Mr. Connelly was the U.S. Marketing Manager
for the Instrument Group at Abbott Laboratories, which he joined in 1983, where
he was responsible for the marketing of chemistry and hematology systems and
point-of-care and near-patient testing instruments.
GEORGE V. MIGAUSKY has been associated with IGEN as Chief Financial Officer
since 1985, assuming that position on a full-time basis in 1992. Between 1985
and 1992, in addition to serving as Chief Financial Officer of IGEN on a
part-time basis, Mr. Migausky also served as financial advisor to several other
privately held companies. Prior to joining IGEN in 1985, he spent nine years in
financial management and public accounting positions, most recently as a Manager
with the High Technology Group of Deloitte Haskins & Sells.
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PART II
ITEM 5. MARKET FOR REGISTRANT'S COMMON STOCK AND RELATED STOCKHOLDER MATTERS.
The Company's Common Stock is quoted on the NASDAQ National Market System under
the symbol IGEN. As of June 11, 1999, there were approximately 3,500 holders of
record of the Company's Common Stock. No cash dividends have been paid on the
Common Stock to date, and the Company currently intends to retain any earnings
for development of the Company's business.
The following table sets forth, for periods indicated, the range of high and low
closing sales prices of the Common Stock as quoted on the NASDAQ National Market
System.
<TABLE>
<CAPTION>
FISCAL 1998 HIGH LOW
----------- ---- ---
<S> <C> <C>
First Quarter $ 8 $ 4 3/4
Second Quarter $ 13 7/8 $ 7 1/16
Third Quarter $ 15 1/8 $ 10 5/8
Fourth Quarter $ 43 $ 12 1/4
FISCAL 1999
First Quarter $ 45 3/4 $ 30 5/8
Second Quarter $ 40 $ 20 9/16
Third Quarter $ 31 1/8 $ 21 1/2
Fourth Quarter $ 35 $ 24
</TABLE>
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<PAGE>
ITEM 6. SELECTED FINANCIAL DATA.
The selected financial data set forth below with respect to the Company's
consolidated statements of operations for each of the years in the three year
period ended March 31, 1999 and with respect to the balance sheets at March 31,
1999 and 1998 are derived from, and are qualified by reference to, the
consolidated financial statements that have been audited by Deloitte & Touche
LLP, independent auditors, and are included elsewhere in this Form 10-K. The
statement of operations data for each of the years in the two-year period ended
March 31, 1996, and the balance sheet data at March 31, 1997, 1996 and 1995 are
derived from audited financial statements not included in this Form 10-K. The
following selected financial data should be read in conjunction with the
consolidated financial statements and notes thereto included elsewhere in this
Form 10-K.
<TABLE>
<CAPTION>
FISCAL YEAR ENDED MARCH 31,
- ---------------------------------------------------------------------------------------------------------
1999 1998 1997 1996 1995
---- ---- ---- ---- ----
(IN THOUSANDS, EXCEPT PER SHARE DATA)
<S> <C> <C> <C> <C> <C>
Statement of Operations Data:
Revenues:
Product Sales $ 4,949 $ 5,614 $ 6,360 $ 4,583 $ 2,555
Royalty income 9,439 5,024 843 75 20
License fees and contract revenue 510 2,795 8,802 11,266 12,259
-------- -------- -------- -------- --------
Total 14,898 13,433 16,005 15,924 14,834
-------- -------- -------- -------- --------
Operating Costs and Expenses:
Products Costs 1,340 1,716 2,448 1,848 1,278
Research and development 14,271 11,615 13,114 14,078 12,267
Marketing, general and
administrative 13,247 11,761 10,910 8,725 8,707
-------- -------- -------- -------- --------
Total operating expenses 28,858 25,092 26,472 24,651 22,252
-------- -------- -------- -------- --------
Loss from operations (13,960) (11,659) (10,467) (8,727) (7,418)
Interest Income - net 687 54 586 1,079 1,489
Other expense (36) (225) -- -- --
-------- -------- -------- -------- --------
Net loss $(13,309) $(11,830) $ (9,881) $ (7,648) $ (5,929)
-------- -------- -------- -------- --------
-------- -------- -------- -------- --------
Net loss per share $ (1.00) $ (.82) $ (.66) $ (.52) $ (.40)
-------- -------- -------- -------- --------
-------- -------- -------- -------- --------
Shares used in computing net loss per
share 15,318 15,116 14,959 14,779 14,769
-------- -------- -------- -------- --------
-------- -------- -------- -------- --------
</TABLE>
<TABLE>
<CAPTION>
MARCH 31,
- -------------------------------------------------------------------------------------------------
1999 1998 1997 1996 1995
---- ---- ---- ---- ----
(IN THOUSANDS)
<S> <C> <C> <C> <C> <C>
Balance Sheet Data:
Cash, cash equivalents and short-term
investments $ 34,374 $ 23,122 $ 9,044 $ 20,217 $ 30,226
Working capital 32,327 17,590 4,431 13,700 21,484
Total assets 45,823 30,391 17,794 29,276 37,806
Long term obligations 32,704 146 158 329 418
Accumulated deficit (81,839) (68,530) (56,700) (46,819) (39,171)
Shareholders' equity 5,590 20,862 7,882 17,435 24,998
</TABLE>
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ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS.
OVERVIEW
The Company has devoted substantially all of its resources to the research and
development of its proprietary technologies, primarily the ORIGEN technology for
clinical diagnostic and life science research products. Historically, the
Company's sources of revenue consisted primarily of license or research payments
pursuant to licensing or collaborative research agreements. The Company has
entered into arrangements with corporate collaborators that provide for the
development and marketing of certain ORIGEN-based systems. These agreements
provide fees and royalties payable to the Company in exchange for licenses to
produce and sell products. Beginning in the fourth quarter of fiscal 1997, the
Company's revenues from license fees and contract research were substantially
replaced by royalties based on its licensees' product sales. In the fiscal year
ended March 31, 1999, 97% of the Company's revenues resulted from product sales,
either by IGEN or its corporate licensees. Going forward, the Company expects an
increasing amount of its revenues to be derived from sales of its products and
royalties from corporate collaborations; however, the Company may selectively
pursue additional strategic alliances, which could result in additional contract
revenues.
RESULTS OF OPERATIONS
YEARS ENDED MARCH 31, 1999 AND 1998. The Company had a net loss of $13.3 million
($1.00 per share) on revenues of $14.9 million for the year ended March 31,
1999. This compares with a net loss of $11.8 million ($0.82 per share) on
revenues of $13.4 million for the corresponding prior year ended March 31, 1998.
During fiscal 1999, $14.4 million (97%) of the Company's revenue was generated
from the sale of products, either directly by IGEN or from royalties on
licensees sales. This represents a 35% increase from the $10.6 million of
revenue recorded last year from comparable sources.
Pursuant to the Company's agreement with Roche, (the "Agreement"), Roche
launched its Elecsys product line in 1996, which is based on IGEN's ORIGEN
technology. The Company is involved in litigation with Roche arising out of this
agreement. See Item 3, "Legal Proceedings". One of the disputes in the
litigation relates to the computation of royalties to which the Company is
entitled under the Agreement. The Company recorded royalty income from this
Agreement of $8.6 million and $4.4 million for the years ended March 31, 1999
and 1998, respectively.
Product costs were $1.3 million (27% of product sales) for the year ended March
31, 1999 compared to $1.7 million (31% of product sales) for the corresponding
prior year. Lower product costs and improved gross margins are attributable to a
change in product mix between instruments, services and reagents and the
elimination of sales to Organon Teknika for which the Company received no gross
margin.
Operating costs, excluding product costs, increased to $27.5 million in the
fiscal 1999 compared to $23.4 million during fiscal 1998. During fiscal 1999,
research and development costs increased $2.7 million (23%) to $14.3 million
from $11.6 million in fiscal 1998 due to higher personnel and development
expenses associated with development of the M-SERIES High Throughput Screening
System. There was an increase in marketing, general and administrative expenses
in fiscal 1999 over the prior year of $1.5 million (13%) due primarily to
professional and legal fees associated with the Company's litigation with Roche.
31
<PAGE>
ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS (CONTINUED)
Financial Accounting Standards Board ("FASB") issued SFAS No. 133, ACCOUNTING
FOR DERIVATIVE INVESTMENTS AND HEDGING ACTIVITIES. SFAS 133 is effective for
years beginning after June 15, 1999. The Company does not believe that adoption
of SFAS 133 will have a material impact on its financial position or results of
operations.
Interest income, net of other expense, increased $600,000 from higher cash
balances and the reduction of interest expense associated with the advance
royalty agreement with Roche, which was repaid during the first quarter of
fiscal 1999. As a result of the Company's issuance of $30 million of notes in
March 1999, the Company's interest expense will increase in Fiscal 2000 compared
to 1999.
Income (loss) from continuing operations over the next several years is likely
to fluctuate substantially from quarter to quarter as a result of differences in
the timing of revenues earned under license and product development agreements,
and associated product development expenses.
As of March 31, 1999, the Company had net operating loss and general business
credit tax carryforwards of approximately $70 million and $3 million,
respectively. The Company's ability to utilize its net operating loss and
general business credit tax carryforwards may be subject to an annual limitation
in future periods pursuant to the "change in ownership rules" under Section 382
of the Internal Revenue Service Code of 1986, as amended.
YEARS ENDED MARCH 31, 1998 AND 1997. The Company had a net loss of $11.8 million
($.82 per share) on revenues of $13.4 million for the year ended March 31, 1998.
This compares with a net loss of $9.9 million ($.66 per share) on revenues of
$16 million for the corresponding prior year ended March 31, 1997. During fiscal
1998, $10.6 million (79%) of the Company's revenue was generated from the sale
of products, either directly by IGEN or from royalties on licensees sales. This
represents a 47% increase from the $7.2 million of revenue recorded in fiscal
1997 from comparable sources. During the fourth quarter of fiscal 1997, the
Company's license and contract revenue converted to royalty income based on
product sales of corporate licensees. Revenue from license fees and contract
research were substantially replaced by royalties based on sales. Therefore,
while royalty revenue increased during fiscal 1998, revenue from license fees
and contract research decreased to $2.8 million from $8.8 million in fiscal
1997. The Company recorded royalty income from the Agreement of $4.4 million and
$706,000 for the years ended March 31, 1998 and 1997, respectively. These
amounts were offset by a $6 million advance, secured by future royalties,
received from Roche in January 1997.
Product costs were $1.7 million (31% of product sales) for the year ended March
31, 1998 compared to $2.4 million (38% of product sales) for the corresponding
prior year. Lower product costs and improved gross margins are attributable to a
change in product mix between instruments, services and reagents and the
reduction of sales to Organon Teknika for which the Company received no gross
margin.
Operating costs, excluding product costs, decreased to $23.4 million in the
fiscal 1998 compared to $24 million during fiscal 1997. During fiscal 1998,
research and development costs decreased $1.5 million (11%) to $11.6 million
from $13.1 million in fiscal 1997 due to expiring external collaborations.
Partially offsetting this decrease was an $851,000 (8%) increase in marketing,
general and administrative expenses in fiscal 1998 over the prior year due
primarily to professional and legal fees associated with the Company's
litigation with Roche.
32
<PAGE>
ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS (CONTINUED)
Interest income, net of other expense, decreased $532,000 because of lower cash
balances through the first nine months of fiscal 1998 coupled with accrued
interest expense associated with the advanced royalty agreement with Roche
initiated during the fourth quarter of fiscal 1997.
LIQUIDITY AND CAPITAL RESOURCES
The Company has financed its operations through the sale of Preferred and Common
Stock, aggregating approximately $85 million through March 31, 1999. Also, in
March 1999, the Company completed a $30 million debt financing with John Hancock
Life Insurance Company. The seven year, 8.5% Senior Secured Notes mature in 2006
with quarterly interest only payments of $637,5000 through September 2000. In
December 2000, principal and interest installments of $1.7 million will be due
quarterly through March 2006. Collateral for the debt is represented by royalty
payments and rights of the Company to receive monies due pursuant to the
Company's license agreement with Roche. Plans for the net proceeds from this
financing include continuing research and development, as well as working
capital needs related to general corporate expenditures, including the sales and
marketing efforts related to the launch of the M-SERIES High Throughput
Screening System. In addition, the Company has received funds from collaborative
research and licensing agreements, and sales of its ORIGEN line of products. As
of March 31, 1999, the Company had $34 million in cash, cash equivalents and
short term investments. Working capital was $32.3 million at March 31, 1999.
Net cash used for operating activities was $15.5 million, $10 million, and $10.4
million during the years ended March 31, 1999, 1998 and 1997, respectively.
License and collaboration agreements between the Company and its strategic
corporate collaborators provided cumulative payments to the Company of
approximately $80 million through March 31, 1999. Additionally, the Company
received $2.75 million in August 1997 under an advance royalty agreement with
Eisai.
The Company used approximately $1.7 million, $751,000, and $778,000 of net cash
for investing activities substantially related to the acquisition of laboratory
equipment, furniture and leasehold improvements during the years ended March 31,
1999, 1998, and 1997, respectively. Additionally, during fiscal years 1999, 1998
and 1997, the Company incurred capital lease obligations of approximately
$180,000, $80,000, and $113,000, respectively, related to acquisition of
laboratory equipment, furniture and leasehold improvements. The Company believes
material commitments for capital expenditures may be required in a variety of
areas, such as product development programs. The Company has not, at this time,
made commitments for any such capital expenditures or secured additional sources
to fund such commitments.
The Company has no reason to believe that the existence of the Roche litigation
is having a material adverse affect on Roche's sales pursuant to its agreement
with IGEN or that a negative result for the Company in the Roche litigation
would have a material adverse affect on Roche's sales, although there can be no
assurance that the litigation or its outcome would not have such an effect. As
it now stands, Roche will have the right to continue to market its Elecsys
products to central hospital laboratories and clinical reference laboratories
during the term of the agreement unless and until the Company is determined to
have the right to terminate the agreement and then determines to terminate the
agreement. If the Company elects to terminate the agreement, it would have a
material adverse effect on the
33
<PAGE>
ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS (CONTINUED)
Company's royalty revenue from license sales unless and until the Company
entered into a strategic partnership with another company that is able to
commercialize diagnostic instruments to hospitals and clinical reference
laboratories. There can be no assurance, if the Company decided to terminate the
Agreement, that the Company would be able to enter into such a strategic
partnership on terms favorable to the Company.
The Company does not expect that failure to prevail in the Hitachi litigation by
itself would have a material adverse effect on the Company's revenue or sales,
since Hitachi would continue to manufacture Roche instruments and the Company
would continue to earn royalties in connection therewith. There can be no
assurance that the Company's failure in the Hitachi litigation would not have a
material adverse effect or the success by the Company in the Hitachi litigation
could have a material adverse effect on the Company's intellectual property.
Success by the Company in the Hitachi litigation could have a material adverse
effect on the Company's royalty revenues from sales of Elecsys products to the
extent that Roche's sales of Elecsys instruments are hindered because it needs
to find a new manufacturer for its instruments or make arrangements to have
Hitachi manufacture the instruments outside of Japan.
The Company has incurred and expects to incur substantial additional research
and development expenses, manufacturing costs and marketing and distribution
expenses and costs related to the Roche litigation in the future. It is the
Company's intention to selectively seek additional collaborative or license
agreements with suitable corporate collaborators, although there can be no
assurance the Company will be able to enter into such agreements or that amounts
received under such agreements will reduce substantially the Company's funding
requirements. Additional equity or debt financing may be required, and there can
be no assurance that these funds may be available on favorable terms, if at all.
The Company's future capital requirements depend on many factors, including
continued scientific progress in its diagnostics programs, the magnitude of
these programs, the time and costs involved in obtaining regulatory approvals,
the costs involved in filing, prosecuting and enforcing patent claims, competing
technological and market developments, changes in its existing license and other
agreements, the ability of the Company to establish development arrangements,
the cost of manufacturing scale-up and effective commercialization activities
and arrangements.
YEAR 2000 ISSUE
The Year 2000 ("Y2K") issue results from computer programs and hardware that are
unable to distinguish between the Year 1900 and the Year 2000; accordingly,
computer systems that have time-sensitive calculations may not properly
recognize the Year 2000. This could result in system failures or
miscalculations, causing disruptions of the Company's operations, including,
without limitation, research, manufacturing, distribution, and other business
activities. The Y2K problem may affect the Company's computer hardware,
software, systems, devices and applications, and may also affect products
manufactured by collaborators using the Company's technology.
34
<PAGE>
ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS (CONTINUED)
The Company has conducted a review of its systems to identify those areas that
could be affected by the Y2K problem and has established a program to address
Y2K issues. The Company is installing a Y2K compliant Enterprise Resource
Planning ("ERP") computer system, which will perform substantially all of the
central data processing tasks of the Company. The Company is installing this
system in order to fully integrate its financial systems with its manufacturing
and distribution systems and provide for the growth of its business and not as a
concern about the Y2K problem. The Company has completed installation of the
financial systems. While existing manufacturing and distribution systems are Y2K
compliant, the new manufacturing and distribution installations are planned for
completion during the fourth calendar quarter of 1999.
Most of the Company's other information technology systems, including desktop
computers, server computer equipment and installed commercial application
software, are relatively new and have been designed with the Y2K issue in mind.
The Company has completed testing of these information technology systems that
are material to the Company's business. To the extent that these systems are
found not to be Y2K compliant, the Company believes that any material issues can
be resolved by installing commercially available upgrades.
In addition to reviewing its systems, the Company has also considered the impact
of the Y2K issue on products that it manufactures and on products manufactured
by collaborators using the Company's technology. In all material respects,
products manufactured by the Company are Y2K compliant. The Company is aware
that certain products manufactured by collaborators using the Company's
technology may utilize calendar dates. Where known, the Company has contacted
collaborators to ascertain their awareness of the problem and their plans to
address the Y2K issue. Roche has indicated to IGEN that its Elecsys products are
currently Y2K compliant or can be made Y2K compliant with a currently available
software upgrade.
The Company has identified critical providers of information, goods and services
("Suppliers") in order to assess their Y2K compliance and has sent
questionnaires to such critical Suppliers. Although the Company cannot control
the response time of Suppliers to its surveys, the Company has assessed survey
responses received through May 31, 1999 and confirmed year 2000 readiness of
selected Suppliers. Additional open responses continue to be monitored and the
Company anticipates to have confirmed Year 2000 readiness by September 30, 1999.
The Company does not intend to contact entities that are not critical and cannot
guarantee that such entities will be Y2K compliant. There can be no assurance
that the Company's suppliers are, or will be, Y2K compliant or that a failure of
timely Y2K compliance on the part of the Suppliers would not have a material
adverse effect on the Company.
The Company's business operations are also dependent upon the Y2K readiness of
infrastructure suppliers in areas such as utilities, communications,
transportation and other services. The Company has been unable to assess the
likelihood, length or effects of failures by any of these suppliers and there
can be no assurance that such failures will not have a material adverse effect
on the Company.
The Company has not incurred, and does not expect to incur, material costs in
conjunction with its Y2K remediation plan. The majority of the costs incurred to
date are related to the installation of the ERP system. As described above, the
Company did not undertake this project to specifically address the Y2K issue and
the installation has not been accelerated or otherwise modified as a result of
the Y2K issue.
35
<PAGE>
At the current time, the Company anticipates that its critical information and
non-information technology systems will be Y2K compliant in all material
respects before January 1, 2000. Although the Company does not expect, in view
of its Y2K readiness efforts and diversity of its suppliers and customers, the
occurrence of Y2K failures to have a material adverse effect on the financial
position or results of operations of the Company, there can be no assurance of
complete Y2K compliance.
Contingency plans for information technology systems generally anticipate use of
standard non-customized replacement modules in the event of contingencies. Work
with major collaborators and vendors to date has indicated a high awareness of
the issues and plans to address them. Alternative vendors are available for most
major supplies and raw materials. Nonetheless, it is not possible for the
Company to fully assess the likelihood or magnitude of consequences from vendor
or collaborator Y2K compliance issues. While there are no indications of major
revenue disruptions from actions of such third parties, there can be no
assurance at this time as to the future impacts of Y2K actions or inactions by
collaborators or vendors.
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Changes in interest rates do not affect interest expense incurred on the
Company's long-term borrowings because it bears interest at a fixed rate. Terms
of this debt are as follows: $30 million principal, Seven year 8.5% Senior
Secured Notes secured by future royalty revenue from Roche, maturing in 2006
with quarterly interest only payments through September 2000 and quarterly
principal and interest payments through March 2006. However, the Company runs a
risk that market rates will decline and that the interest rate will exceed those
based on the then current market rate. The Company is currently not using
interest rate derivative instruments to manage its exposure to interest rate
changes.
Interest income earned on the Company's investment portfolio is affected by
changes in the general level of interest rates. The Company has invested its
excess cash generally in securities of the U.S. Treasury, money market funds,
certificates of deposit and corporate bonds. The Company invests its excess cash
in accordance with a policy objective that seeks to ensure both liquidity and
safety of principal. The policy limits investments to certain types of
instruments issued by institutions with strong investment grade credit ratings
and places restrictions on their terms and concentrations by type and issuer.
36
<PAGE>
ITEM 8. CONSOLIDATED FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA.
<TABLE>
<CAPTION>
INDEX TO FINANCIAL STATEMENTS PAGE
<S> <C>
Independent Auditors' Report 38
Consolidated Statements of Operations for the Three Years 39
Ended March 31, 1999, 1998 and 1997
Consolidated Balance Sheets at March 31, 1999 and 1998 40
Consolidated Statements of Cash Flows for the Three Years 41
Ended March 31, 1999, 1998 and 1997
Consolidated Statements of Stockholders' Equity for the Three Years 42
Ended March 31, 1999, 1998, and 1997
Notes to Consolidated Financial Statements 43
</TABLE>
37
<PAGE>
INDEPENDENT AUDITORS' REPORT
TO THE STOCKHOLDERS AND BOARD OF DIRECTORS
OF IGEN INTERNATIONAL, INC.:
We have audited the accompanying consolidated balance sheets of IGEN
International, Inc. (the Company) as of March 31, 1999 and 1998, and the related
consolidated statements of operations, stockholders' equity, and cash flows for
each of the three years in the period ended March 31, 1999. These financial
statements are the responsibility of the Company's management. Our
responsibility is to express an opinion on these financial statements based on
our audits.
We conducted our audits in accordance with generally accepted auditing
standards. Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are free of material
misstatement. An audit includes examining, on a test basis, evidence supporting
the amounts and disclosures in the financial statements. An audit also includes
assessing the accounting principles used and significant estimates made by
management, as well as evaluating the overall financial statement presentation.
We believe that our audits provide a reasonable basis for our opinion.
In our opinion, the consolidated financial statements referred to above present
fairly, in all material respects, the financial position of the Company as of
March 31, 1999 and 1998, and the results of its operations and its cash flows
for each of the three years in the period ended March 31, 1999, in conformity
with generally accepted accounting principles.
Deloitte & Touche LLP Washington, D.C.
May 10, 1999
38
<PAGE>
IGEN INTERNATIONAL, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(IN THOUSANDS EXCEPT PER SHARE AMOUNTS)
<TABLE>
<CAPTION>
1999 1998 1997
---- ---- ----
<S> <C> <C> <C>
REVENUES (Notes 1 and 2):
Product sales $ 4,949 $ 5,614 $ 6,360
Royalty income 9,439 5,024 843
License fees and contract revenue 510 2,795 8,802
-------- -------- --------
Total 14,898 13,433 16,005
-------- -------- --------
OPERATING COSTS AND EXPENSES:
Product costs 1,340 1,716 2,448
Research and development (Note 2) 14,271 11,615 13,114
Marketing, general, and administrative 13,247 11,761 10,910
-------- -------- --------
Total 28,858 25,092 26,472
-------- -------- --------
LOSS FROM OPERATIONS (13,960) (11,659) (10,467)
INTEREST INCOME - NET 687 54 586
OTHER EXPENSE (Note 5) (36) (225) --
-------- -------- --------
NET LOSS $(13,309) $(11,830) $ (9,881)
-------- -------- --------
-------- -------- --------
LOSS PER SHARE (Note 1):
Basic and Diluted loss per common share $ (1.00) $ (0.82) $ (0.66)
-------- -------- --------
-------- -------- --------
SHARES USED IN COMPUTING
NET LOSS PER SHARE (Note 1) 15,318 15,116 14,959
-------- -------- --------
-------- -------- --------
</TABLE>
SEE NOTES TO CONSOLIDATED FINANCIAL STATEMENTS.
39
<PAGE>
IGEN INTERNATIONAL, INC.
CONSOLIDATED BALANCE SHEETS
(IN THOUSANDS EXCEPT SHARE DATA)
<TABLE>
<CAPTION>
March 31,
ASSETS 1999 1998
------ ---- ----
<S> <C> <C>
CURRENT ASSETS:
Cash and cash equivalents (Note 1) $ 720 $ 1,502
Short term investments (Note 1) 33,654 21,620
Accounts receivable, net 3,252 1,552
Inventory (Note 1) 1,455 1,435
Other current assets 775 864
-------- --------
Total current assets 39,856 26,973
-------- --------
EQUIPMENT, FURNITURE, AND IMPROVEMENTS (Note 1) 9,025 7,124
Accumulated depreciation and amortization (5,397) (4,111)
-------- --------
Equipment, furniture, and improvements, net 3,628 3,013
-------- --------
NONCURRENT ASSETS:
Deferred debt issuance costs (Note 4) 1,361 --
Restricted cash (Notes 1, 4) 600 --
Other 378 405
-------- --------
Total noncurrent assets 2,339 405
-------- --------
TOTAL $ 45,823 $ 30,391
-------- --------
-------- --------
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES:
Accounts payable and accrued expenses $ 4,924 $ 5,152
Deferred revenue (Notes 1, 2) 2,488 4,139
Obligations under capital leases (Note 8) 117 92
-------- --------
Total current liabilities 7,529 9,383
-------- --------
NONCURRENT LIABLITIES:
Note payable (Note 4) 30,000 --
Convertible preferred stock dividend payable (Note 3)
2,521 --
Obligations under capital leases (Note 8) 183 146
-------- --------
Total noncurrent liabilities 32,704 146
-------- --------
COMMITMENTS AND CONTINGENCIES (See Note 8) -- --
-------- --------
STOCKHOLDERS' EQUITY: (Notes 1, 3)
Convertible preferred stock, $0.001 par value, 10,000,000 shares
authorized, issuable in Series: Series A, 600,000 shares designated, none
issued; Series B, 25,000 shares issued and outstanding - liquidation value
of $25,000,000 plus accrued and unpaid dividends 1 1
Common stock: $.001 par value, 50,000,000 shares authorized: 15,361,465 and
15,261,240 shares issued and outstanding 15 15
Additional paid-in capital 87,413 89,376
Accumulated deficit (81,839) (68,530)
-------- --------
Total stockholders' equity 5,590 20,862
-------- --------
TOTAL $ 45,823 $ 30,391
-------- --------
-------- --------
</TABLE>
SEE NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
40
<PAGE>
IGEN INTERNATIONAL, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(IN THOUSANDS)
<TABLE>
<CAPTION>
1999 1998 1997
---- ---- ----
<S> <C> <C> <C>
CASH FLOWS FROM OPERATIONS:
Net loss $(13,309) $(11,830) $ (9,881)
Adjustments to reconcile net loss to net cash used in operating activities:
Loss on disposal of equipment, furniture and improvements -- 53 --
Depreciation and amortization 1,313 889 1,320
Deferred revenue (1,651) (1,254) (2,140)
Add (deduct) items not affecting cash:
(Increase) decrease in accounts receivable (1,700) 648 (308)
(Increase) decrease in inventory (20) 640 (426)
Decrease in other current assets 89 2 590
(Decrease) increase accounts payable and accrued expenses (228) 886 473
-------- -------- --------
Net cash used in operating activities (15,506) (9,966) (10,372)
-------- -------- --------
CASH FLOWS FROM INVESTING ACTIVITIES:
Expenditures for equipment, furniture, and improvements (1,721) (751) (778)
Sale of short-term investments 32,706 8,781 30,726
Purchase of short-term investments (44,740) (22,147) (22,764)
-------- -------- --------
Net cash (used in) provided by investing activities (13,755) (14,117) 7,184
-------- -------- --------
CASH FLOWS FROM FINANCING ACTIVITIES:
Repayment of notes receivable from sale of subscribed stock, net -- 310 40
Proceeds from note payable 30,000 -- --
Disbursements for debt issuance costs (1,361) -- --
Restricted cash (600) -- --
Issuance of convertible preferred stock, net -- 23,428 --
Issuance of common stock - net 558 1,073 200
Payments under capital lease obligations (118) (16) (263)
-------- -------- --------
Net cash provided by (used in) financing activities 28,479 24,795 (23)
-------- -------- --------
NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS (782) 712 (3,211)
CASH AND CASH EQUIVALENTS, BEGINNING OF YEAR 1,502 790 4,001
-------- -------- --------
CASH AND CASH EQUIVALENTS, END OF YEAR $ 720 $ 1,502 $ 790
-------- -------- --------
-------- -------- --------
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION:
Interest Paid $ 61 $ 12 $ 65
SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING AND FINANCING ACTIVITIES:
Capital Lease Obligations incurred for equipment, furniture and
improvements $ 180 $ 80 $ 113
</TABLE>
SEE NOTES TO CONSOLIDATED FINANCIAL STATEMENTS.
41
<PAGE>
IGEN INTERNATIONAL, INC.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY
(IN THOUSANDS)
<TABLE>
<CAPTION>
Notes
Receivable
From
Convertible Additional Sale of
Preferred Stock Common Stock Paid in Accumulated Deferred Subscribed
Shares Amount Shares Amount Capital Deficit Comp. Stock Total
------ ------ ------ ------ ------- ------- ----- ----- -----
<S> <C> <C> <C> <C> <C> <C> <C> <C> <C>
BALANCE
APRIL 1, 1996 -- -- 14,908 $ 15 $64,676 $(46,819) $(91) $ (346) $ 17,435
Issuance of shares of
common stock -- -- 79 -- 200 -- -- -- 200
Amortization of deferred
compensation
-- -- -- -- -- -- 91 -- 91
Changes in notes
receivable -- -- -- -- -- -- -- 36 36
Net loss -- -- -- -- -- (9,881) -- -- (9,881)
----- ------ ------- ----- ------- -------- ------ ----- --------
BALANCE
MARCH 31, 1997 -- -- 14,987 15 64,876 (56,700) -- (310) 7,881
Issuance of shares of
common stock -- -- 274 -- 1,073 -- -- -- 1,073
Issuance of shares of
covertible preferred
stock, net 25 $ 1 -- -- 23,427 -- -- -- 23,428
Changes in notes
receivable -- -- -- -- -- -- -- 310 310
Net loss -- -- -- -- -- (11,830) -- -- (11,830)
----- ------ ------- ----- ------- -------- ------ ----- --------
BALANCE
MARCH 31, 1998 25 1 15,261 15 89,376 (68,530) -- -- 20,862
Issuance of shares of
common stock -- -- 100 -- 558 -- -- -- 558
Preferred stock,
dividends payable -- -- -- -- (2,521) -- -- -- (2,521)
Net loss -- -- -- -- -- (13,309) -- -- (13,309)
----- ------ ------- ----- ------- -------- ------ ----- --------
BALANCE
MARCH 31, 1999 25 $ 1 15,361 $ 15 $87,413 $(81,839) $ -- $ -- $ 5,590
----- ------ ------- ----- ------- -------- ------ ----- --------
----- ------ ------- ----- ------- -------- ------ ----- --------
</TABLE>
SEE NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
42
<PAGE>
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
1. ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
The preparation of financial statements in conformity with generally accepted
accounting principles requires management to make estimates and assumptions that
affect the amounts reported in the financial statements and accompanying notes.
Actual results could differ from those estimates. Certain amounts from the prior
years have been reclassified to conform to the current year presentation.
ORGANIZATION AND BUSINESS ACTIVITY - IGEN International, Inc. (the Company)
develops, manufactures, and markets diagnostic systems utilizing its patented
ORIGEN(R) technology, which is based on electrochemiluminescence.
PRINCIPLES OF CONSOLIDATION - The consolidated financial statements include the
accounts of the Company and its wholly-owned subsidiaries, IGEN Europe, Inc. and
IGEN International, K.K. All significant intercompany transactions and balances
have been eliminated.
CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS - Cash equivalents include cash in
banks, money market funds, securities of the U.S. Treasury, and certificates of
deposit with original maturities of three months or less.
The company has classified its short term investments which consist of U.S.
Government Obligations and Corporate Debt-Securities as "available for sale"
which are recorded at market value. The recorded market value approximates cost.
RESTRICTED CASH - The Company has a debt service reserve of $600,000 as of March
31, 1999 that is restricted in use (See Note 4). These funds are held in trust
as collateral with increasing increments scheduled for each of the first six
quarterly note payable due dates.
CONCENTRATION OF CREDIT RISK - The Company has invested its excess cash
generally in securities of the U.S. Treasury, money market funds, certificates
of deposit and corporate bonds. The Company invests its excess cash in
accordance with a policy objective that seeks to ensure both liquidity and
safety of principal. The policy limits investments to certain types of
instruments issued by institutions with strong investment grade credit ratings
and places restrictions on their terms and concentrations by type and issuer.
The Company has not experienced any losses on its investments, due to credit
risk.
INVENTORY is recorded at the lower of cost or market using the first-in,
first-out method and consists of the following:
<TABLE>
<CAPTION>
(in thousands) 1999 1998
-----------------------------------
<S> <C> <C>
Finished Goods $ 461 $ 824
Work in process 137 117
Raw materials 857 494
------ ------
Total $1,455 $1,435
------ ------
------ ------
</TABLE>
43
<PAGE>
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
EQUIPMENT, FURNITURE, AND IMPROVEMENTS are carried at cost. Depreciation is
computed over the estimated useful lives of the assets, generally five years,
using accelerated methods. Such property consists of the following:
<TABLE>
<CAPTION>
(in thousands) 1999 1998
--------------------------------------------------
<S> <C> <C>
Laboratory equipment $3,805 $2,967
Furniture and office equipment 3,606 2,653
Leasehold improvements 1,614 1,504
------ ------
Total $9,025 $7,124
------ ------
------ ------
</TABLE>
OTHER ASSETS - The Company amortizes the cost of purchased patent rights on a
straight-line basis over the estimated economic lives of such assets, ranging
from five to twenty-one years. Accumulated amortization on purchased product
technology rights was $249,660, $223,400 and $187,300 at March 31, 1999, 1998
and 1997, respectively. The Company amortizes debt issuance costs using the
effective interest method over the terms of the debt agreement.
REVENUE RECOGNITION - Product sales revenue is recorded as products are shipped.
Nonrefundable license fees and milestone payments and service fees in connection
with research and development contracts or commercialization agreements with
corporate partners are recognized when they are earned in accordance with the
applicable performance requirements and contractual terms. Amounts received in
advance of performance under contracts or commercialization agreements are
recorded as deferred revenue until earned.
DEFERRED INCOME TAXES - Deferred income tax assets and liabilities are computed
annually for differences between the financial statement and tax bases of assets
and liabilities that will result in taxable or deductible amounts in the future
based on enacted tax laws and rates applicable to the periods in which the
differences are expected to affect taxable income. A valuation allowance is
established when necessary to reduce deferred tax assets to the amount expected
to be realized. Income tax expense is the tax payable or refundable for the
period plus or minus the change during the period in deferred tax assets and
liabilities.
LOSS PER SHARE - Effective December 31, 1997, the Company adopted Statement of
Financial Accounting Standard No. 128 "Earnings per Share" ("SFAS 128"). The
Company's loss has been adjusted by dividends accumulated at March 31, 1999 and
1998, on the Company's Convertible Preferred Series B Stock. There was no change
in loss per share reported in prior periods related to the adoption of SFAS 128.
See Note 3.
NEW ACCOUNTING STANDARDS
In 1997, the Financial Accounting Standards Board ("FASB") issued SFAS No. 131,
DISCLOSURES ABOUT SEGMENTS OF AN ENTERPRISE AND RELATED INFORMATION, which was
effective for years beginning after December 15, 1997. SFAS No. 131 redefines
how operating segments are determined and requires disclosures about products,
services, major customers and geographic areas. The Company operates as one
business segment with a group of similar products. With the exception of revenue
from
44
<PAGE>
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
Roche and Eisai, no single customer accounted for more than 10% of total
revenue. Revenue from Roche totalled 61%, 39% and 56% of total revenues for the
years ended March 31, 1999, 1998 and 1997, respectively, while revenue from
Eisai totaled 17% for the year ended March 31, 1998.
In June 1998, the FASB issued SFAS No. 133, ACCOUNTING FOR DERIVATIVE
INSTRUMENTS AND HEDGING ACTIVITIES. SFAS No. 133 is effective for years
beginning after June 15, 1999 and requires recognition of all derivatives at
fair value as either assets or liabilities in the statement of financial
position. The Company does not believe that adoption of SFAS No. 133 will have a
material impact on its financial position or results of operation.
2. LICENSE AND RESEARCH AGREEMENTS
In 1992, the Company entered into an agreement with Roche Diagnostics ("Roche"),
(formerly operating as Boehringer Mannheim GmbH), under which that company was
granted rights to develop and market certain clinical diagnostic systems
worldwide based on the Company's ORIGEN technology. Under the terms of the
agreement, the Company received five $10 million license payments annually
through January 1996 which were recognized as revenue on a ratable basis through
December 1996. This agreement also provides the Company with additional payments
for certain product development work, as well as royalties on product sales. The
Company is currently in litigation with Roche (See Note 9).
During 1993, the Company entered into a $20 million license and stock purchase
agreement with Organon Teknika, B.V. Under this agreement, the Company sold
346,135 shares of common stock, granted a license to develop and market certain
diagnostic systems worldwide utilizing the Company's ORIGEN technology and
agreed to invest $5 million in research and development under a joint
development program. Among other things, the agreement provides for royalty
payments to the Company on product sales and for product supply arrangements
between the parties. Under the product supply agreement, there were no sales to
Organon Teknika during the year ended March 31, 1999 and sales were $1.3 million
and $1.4 million, respectively, for the years ended March 31, 1998 and 1997..
During 1990, the Company granted a license to Eisai Co., Ltd., to market in
Japan a certain clinical diagnostic system based on the Company's ORIGEN
technology. The agreement provided license fees of $8 million tied to the
achievement of product development milestones. This agreement also provides for
royalty payments to the Company on product sales. In August 1997, the Company
received $2.75 million as an advance royalty payment of which $ 358,000 and
$290,000 was recognized as revenue in fiscal 1999 and 1998, respectively.
During 1995, the Company formed a joint venture for the development and
commercialization of advanced diagnostic products utilizing a proprietary
combination of multi-array technology together with the Company's ORIGEN
technology. Products based on these technologies would be used for high
throughput, multiparameter analysis for DNA sequencing, clinical chemistry
and immunodiagnostics. The joint venture is named Meso Scale Diagnostics, LLC
("MSD"), and was formed together with Meso Scale Technologies, LLC ("MST"),
which is a non-controlled non-owned affiliated company. The Company has
agreed to provide initial capital contributions to MSD of $5 million over
time, plus certain start up costs, in exchange for a 50% interest and to fund
the organizational and certain ongoing (non-research) operating expenses of
MSD. The Company will also participate in a collaborative research program.
45
<PAGE>
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
For the year ended March 31, 1999 and 1998, the Company has made contributions
of $3.6 and $2.6 million, respectively. The Company has accounted for its
investments in MSD as research and development funding arrangements and,
accordingly, has recorded its payments as research and development expense.
3. STOCKHOLDERS' EQUITY
CONVERTIBLE PREFERRED STOCK - In December 1997, the Company received net
proceeds of $23.4 million from the issuance of 25,000 shares of Series B
Convertible Preferred Stock, stated value $1,000 per share. The Series B
Convertible Preferred Stock is convertible into 1,790,831 shares of Common Stock
of the Company at a rate of $13.96 per share in accordance with the terms of the
Certificate of Designation, Powers, Preferences and Rights. The Series B
Convertible Preferred Stock entitles its holders to a dividend payment of 7.75%
compounded annually on the stated value of the stock and the Company may elect
to make the dividends payable in common shares at a rate of $13.96 per share,
rather than making the dividend payment in cash. If the Company elects to pay
such dividends in shares of common stock, the Company may issue up to 810,174
shares to the holders of Series B Convertible Preferred Stock. Earnings per
share for the years ended March 31, 1999 and 1998, have been adjusted by
accumulated dividends on Series B Convertible Preferred Stock of approximately
$2 million ($0.13 per share) and $541,000 ($.04 per share), respectively. The
resulting calculation results in Net Loss Attributable to Common Shareholders
for the years ended March 31, 1999 and 1998 of approximately $15 million ($1.00
per share) and $12.4 million ($0.82 per share), respectively.
SHAREHOLDER RIGHTS PLAN - In 1996, the Board of Directors adopted a shareholder
rights plan and declared a dividend of one preferred share purchase right for
each outstanding share of common stock par value $.001 per share, of the
Company. The dividend is effective as of November 6, 1996 with respect to the
shareholders of record on that date.
Each Right entitles the registered holder to purchase from the Company one
one-hundredth of a share of Series A Junior Participating Preferred Stock, par
value $.001 per share, of the Company at a price of $65.00 per one one-hundredth
of a Preferred Share, subject to adjustment. The description and terms of the
Rights are set forth in a Rights Plan between the Company and The First National
Bank of Boston.
STOCK OPTION PLAN - The Company adopted the 1994 Stock Option Plan under which
1,750,000 shares of Common Stock have been reserved for issuance upon exercise
of options granted to employees or consultants and the 1994 Non-Employee
Directors Stock Option Plan under which 150,000 shares of Common Stock have been
reserved for issuance upon exercise of options granted to Non-Employee
Directors. The 1994 Stock Option Plan replaced the 1985 Stock Option Plan which
expired in February 1995 and continues to have unexercised options.
The Option Plans provide for the granting of both incentive stock options
intended to qualify as such under Section 422 of the Internal Revenue Code of
1986, as amended, and supplemental stock options that do not so qualify.
Generally, the options vest 20% after year one and ratably over the following 16
quarters, expiring ten years from date of grant.
46
<PAGE>
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
A summary of the option activity is as follows:
<TABLE>
<CAPTION>
(in thousands) Weighted Average Range of Exercise
Number of Shares Exercise Price Price
---------------- -------------- -----
<S> <C> <C> <C>
Outstanding on April 1, 1996 1,493 $2.60 $0.29 - $9.63
Granted 310 $5.00 $5.00
Exercised (79) $2.80 $0.29 - $5.50
Forfeited (83) $3.90 $0.29 - $5.50
-----
Outstanding on March 31, 1997 1,641 $2.69 $0.29 - $9.63
Granted 601 $6.67 $6.00 -$20.625
Exercised (274) $3.91 $0.29 - $8.75
Forfeited (33) $5.29 $4.57 - $5.50
-----
Outstanding on March 31, 1998 1,935 $5.52 $0.29 - $20.00
Granted -- -- --
Exercised (100) $5.58 $0.29 - $14.00
Forfeited (30) $14.38 $4.87 - $20.625
-----
Outstanding on March 31, 1999 1,805 $7.77 $0.29 - $20.625
-----
-----
(Weighted Average Remaining Contractual
Life is 5.45 years)
</TABLE>
At March 31, 1999, there were approximately 1.3 million stock options
exercisable, under the Plan with a Weighted Average Exercise Price of $5.86.
STOCK-BASED COMPENSATION - In 1997, the Company adopted Statement of Financial
Accounting Standard No. 123 ("SFAS 123"), ACCOUNTING FOR STOCK-BASED
COMPENSATION. Upon adoption of SFAS 123, the Company continues to measure
compensation expense for its stock-based employee compensation plans using the
intrinsic value method prescribed by APB No. 25, ACCOUNTING FOR STOCK ISSUED TO
EMPLOYEES, and has provided below pro forma disclosures of the effect on net
loss and loss per share as if the fair value-based method using the
Black-Scholes model prescribed by SFAS 123 had been applied in measuring
compensation expense.
If compensation cost for the Company's fiscal 1999, 1998 and 1997 grants for
stock-based compensation had been determined consistent with the fair
value-based method of accounting per SFAS 123, the Company's pro forma net loss
and pro forma loss per share for the years ended March 31, 1999, 1998 and 1997
would be as follows:
<TABLE>
<CAPTION>
1999 1998 1997
---- ---- ----
<S> <C> <C> <C>
Net loss (in thousands)
As reported $(13,309) $(11,830) $(9,881)
Pro forma $(15,359) $(12,130) $(9,996)
Basic loss per share
As reported $ (1.00) $ (0.82) $ (0.66)
Pro forma $ (1.13) $ (0.84) $ (0.67)
</TABLE>
47
<PAGE>
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
The fair value of the option grant is estimated on the date of grant using the
Black-Scholes option pricing models with the following assumptions:
<TABLE>
<CAPTION>
1999 1998 1997
---- ---- ----
<S> <C> <C> <C>
Expected dividend yield 0% 0% 0%
Expected stock price volatility 82.51% 53.24% 3.5%
Risk-free interest rate 5.58% 6.74% 6%
Expected option term 5 years 5 years 5 years
</TABLE>
4. NOTE PAYABLE
In March 1999, the Company entered into a debt financing with John Hancock
Mutual Life Insurance Company under a Note Purchase Agreement from which the
Company received $30 million. The seven year, 8.5% Senior Secured Notes mature
in 2006 with quarterly interest only payments of $637,500 through September
2000. Beginning December 2000, principal and interest installments of $1.7
million will be due quarterly through March 2006.
Collateral for the debt is represented by royalty payments and rights of the
Company to receive monies due pursuant to the Company's license agreement with
Roche. Additional collateral is represented by a Restricted Cash balance of
$600,000 initiated at closing. The Restricted Cash will have increasing
increments for each of the first six quarterly periods to a maximum of $1.7
million. Covenants within the Note Purchase Agreement include compliance with
annual and quarterly Royalty Payment Coverage Ratios which are tied to royalty
payments and debt service.
Costs associated with obtaining the debt financing totaling $1.4 million were
deferred and are represented as a noncurrent asset on the balance sheet. These
costs will be amortized over the seven year life of the Note.
The Company has committed to note principal and interest payments of $2.6
million and $4.7 million for the years ending March 31, 2000 and 2001,
respectively, and $6.9 million in each of the years ending March 31, 2002, 2003
and 2004, with payments totaling $13.8 million thereafter.
5. INCOME TAXES
For the years ended March 31, 1999, 1998 and 1997, the Company recorded no
federal or state income tax expense and did not pay federal or state tax, as
calculated by applying statutory rates to pretax income. During fiscal 1998, the
Company received a $4.75 million payment from its Japanese corporate partner,
Eisai, Ltd net of the Japanese tax withholding of $475,000. The Company
recognized revenues of $358,400 and $2.3 million under this arrangement in
fiscal 1999 and 1998, and recorded the associated foreign tax of $35,800 and
$225,000 which is reflected in Other Expense in the financial statements.
48
<PAGE>
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
As of March 31, 1999, the Company has available for income tax reporting
purposes net operating loss and general business credit carryforwards
approximating $70 million and $3 million, respectively. These carryforwards
expire in varying amounts through March 31, 2014. The use of the Company's net
operating loss carryforward may be significantly reduced, if substantial changes
in stock ownership take place. The potential tax benefits of the unused
carryforwards have not been recorded for financial statement purposes because of
the uncertainty of realizing those benefits in the future.
The approximate tax effects of temporary differences that gave rise to the
Company's deferred tax assets and liabilities are as follows:
<TABLE>
<CAPTION>
Year Ended March 31,
(in thousands) 1999 1998
-------------- ---- ----
<S> <C> <C>
Deferred tax assets:
Deferred revenue $ 945 $ 1,571
Net operating loss and tax credit carryforwards 29,603 23,727
Other 94 61
Less valuation allowance (30,642) (25,359)
-------- --------
Net deferred tax assets $ -- $ --
-------- --------
-------- --------
</TABLE>
6. EMPLOYEE SAVINGS PLAN
The Company has an Employee Savings Plan (the Plan) qualifying under Section
401(k) of the Internal Revenue Code and subject to the Employee Retirement
Income Security Act of 1974, as amended. Effective April 1, 1997, the Company
began contributing a 25% match on the first 6% of contributions from qualified
individuals participating in the Plan. This Company contribution totaled
$180,600 and $129,000 for the years ended March 31, 1999 and 1998, respectively.
The Company is not obligated under any other postretirement benefit plan.
7. RELATED PARTIES
Certain shareholders of the Company are also shareholders of several other
companies which are considered affiliates of IGEN for the purpose of this
disclosure. As discussed in Note 2, the Company has entered into transactions
with companies that were affiliated through common shareholders. Amounts due
from affiliated companies for services rendered and certain shared costs were
approximately $44,500, and $43,500 at March 31, 1999 and 1998, respectively.
During 1997, the Company incurred approximately $212,500 in expenses under a
research contract with an affiliate. There were no such expenditures made in
fiscal years 1999 or 1998.
The Company has licensed certain diagnostic technologies from affiliated
companies and has licensed certain pharmaceutical technologies to affiliated
companies. No royalties have ever been earned or accrued under these license
agreements.
49
<PAGE>
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
8. COMMITMENTS AND CONTINGENCIES
CAPITAL LEASES - The Company is obligated under capital lease agreements, for
certain equipment, furniture and building improvements. The aggregate discounted
lease payments are recorded as a liability, and the fair market value of the
related leased assets are capitalized and amortized over the assets estimated
useful lives. Total assets capitalized pursuant to such agreements were
approximately $500,000 at March 31, 1999 with accumulated depreciation totaling
approximately $200,000.
The future minimum payments (in thousands) under these lease agreements at March
31, 1999 are as follows:
<TABLE>
<S> <C>
2000 $ 156
2001 99
2002 66
2003 60
-----
Total minimum payments 381
Amount representing interest (81)
-----
Obligations under capital leases 300
Current portion (117)
-----
Obligations under capital leases - noncurrent $ 183
-----
-----
</TABLE>
OPERATING LEASES - During 1995, the Company entered into a lease for an office,
laboratory and manufacturing facility with a term of ten years, and an option to
terminate the lease after five years. Rent expense for facility and equipment
operating leases totaled approximately $1.5 million for the years ended March
31, 1999, 1998, and 1997, respectively.
RESEARCH AGREEMENTS - The Company has entered into agreements with entities to
fund research and development programs.
At March 31, 1999, the future minimum lease and research payments under these
agreements are as follows:
<TABLE>
<CAPTION>
Research
(in thousands) Operating Leases Agreements
---------------- ----------
<S> <C> <C>
2000 $1,479 $1,000
2001 1,523 200
2002 1,569 --
2003 1,615 --
2004 1,664 --
Thereafter 1,424 --
------ ------
Total $9,274 $1,200
------ ------
------ ------
</TABLE>
50
<PAGE>
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
9. LITIGATION
ROCHE
On September 15, 1997, the Company filed a lawsuit in Maryland against Roche
Diagnostics GmbH (then known as Boehringer Mannheim GmbH or BMG), a German
company, to which the Company has licensed certain rights to develop and
commercialize diagnostic products based on the Company's ORIGEN technology. BMG
was acquired by F. Hoffman LaRoche during 1998, and is referred to herein as
Roche. That lawsuit is pending in the Southern Division of the United States
District Court for the District of Maryland. The Company's dispute with Roche
arises out of a 1992 License and Technology Development Agreement (the
"Agreement"), pursuant to which Roche developed and launched its "Elecsys" line
of diagnostic products, which is based on ORIGEN technology. The Company alleges
that Roche has failed to perform certain material obligations under the
Agreement, including development and commercialization of ORIGEN technology
according to the contractual timetable; exploitation of the license to the
extent contemplated by the parties; phase out of certain non-royalty-bearing
product lines; exploitation of ORIGEN technology only within Roche's licensed
fields; proper treatment of intellectual property rights regarding ORIGEN
technology; maintenance of records essential to the computation of royalties;
and proper computation and payment of royalties. In its lawsuit, the Company
seeks damages as well as injunctive and declaratory relief, including a judicial
determination of its entitlement to terminate the Agreement. The Company
voluntarily has agreed not to terminate the Agreement unless and until the Court
determines its entitlement to do so.
During 1998, the Company filed a motion for preliminary injunction in its
Maryland lawsuit against Roche. In that motion, the Company requested that the
court enjoin Roche from marketing, selling, or distributing its Elecsys products
outside of Roche's licensed field of use. The 1992 Agreement granted Roche
rights to develop and commercialize diagnostic systems based on the Company's
ORIGEN technology for use in centralized hospital laboratories and clinical
reference laboratories only. The Company retains the rights to exploit its
ORIGEN technology in all other clinical diagnostic markets. The Company learned
that Roche was marketing Elecsys products outside of its licensed field of use
and therefore asked the court to enjoin Roche from selling outside of its
licensed field and, in particular, to physicians' offices and physicians' office
laboratories. The Company also sought additional relief, including an order
requiring Roche to refer all customers outside of Roche's licensed field to the
Company for future reagent supply needs and to place all revenues derived from
unauthorized sales in escrow pending the outcome of the litigation. The court
granted IGEN's motion in July 1998 and issued a preliminary injunction in
October 1998. Roche has appealed the preliminary injunction.
In December 1998, Roche filed a counterclaim against the Company asserting five
causes of action: fraud, breach of contract, tortious interference with business
relations, unjust enrichment/equitable recoupment, and reformation. The Company
believes that Roche's claims are unfounded. In March 1999, the Company moved to
dismiss Roche's claims for fraud, tortious interference with business relations,
unjust enrichment/equitable recoupment and reformation. The Company also moved
the court to dismiss a portion of Roche's breach of contract claim and to strike
Roche's request for punitive damages and injunctive relief. After being served
with the Company's motion to dismiss, Roche dropped its complaint for contract
reformation and part of its tortious interference claim. In June 1999, the court
dismissed Roche's claims for fraud, tortious interference, and unjust
enrichment/equitable
51
<PAGE>
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
recoupment and struck down Roche's request for punitive damages and injunctive
relief. Roche's breach of contract counterclaim remains outstanding.
This litigation against Roche may have a material adverse effect upon the
Company regardless of whether the outcome is favorable or not.
The Company recorded royalty income from this Agreement of $8.6 million, $4.4
million and $706,000 for the years ended March 31, 1999, 1998 and 1997,
respectively.
HITACHI
In December 1997, IGEN International K.K.(IGEN K.K."), a Japanese subsidiary of
the Company, filed a lawsuit in Tokyo District Court against Hitachi Ltd.
("Hitachi"). The lawsuit seeks to enjoin Hitachi from infringing IGEN K.K.'s
license registration, (known in Japan as a "senyo-jisshi-ken") to prevent
Hitachi from manufacturing, using or selling the Elecsys 2010 Instrument, which
incorporates IGEN's patented ORIGEN technology, in Japan. Hitachi is the sole
manufacturer for Roche of the Elecsys 2010 immunoassay instrument. Roche is
licensed to market the Elecsys 2010 worldwide, except for Japan, to central
hospital laboratories and clinical reference laboratories. The Company's ORIGEN
technology is licensed in Japan to IGEN K.K. and to Eisai Company, Ltd. The
lawsuit requests injunctive relief against Hitachi.
OTHER MATTERS
From time to time, claims and pending legal proceedings arise that generally
involve the Company's technology and possible patent infringement. These cases
are routine matters in which disposition of such proceedings are not expected to
have a material adverse effect on the Company's financial position, results of
operations or cash flows.
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND
FINANCIAL DISCLOSURE.
Not Applicable.
PART III
Certain information required by Part III is omitted from this Report in that the
Registrant will file a definitive proxy statement pursuant to Regulation 14A
(the "Proxy Statement") not later than 120 days after the end of the fiscal year
covered by this Report, and certain information included therein is incorporated
herein by reference. Only those sections of the Proxy Statement which
specifically address the items set forth herein are incorporated by reference.
52
<PAGE>
ITEM 10. DIRECTORS AND EXECUTIVE OFFICERS OF THE REGISTRANT.
(a) DIRECTORS. The information with respect to directors required
under this item is incorporated herein by reference to the section
captioned "Election of Directors" in the Company's Proxy Statement
with respect to the Annual Meeting of Shareholders to be held on
September 15, 1999.
(b) EXECUTIVE OFFICERS. The information with respect to executive
officers required under this item is incorporated herein by
reference to Part I of this Report.
ITEM 11. EXECUTIVE COMPENSATION.
The information required under this item is incorporated herein by reference to
the sections entitled "Election of Directors -- Compensation for Directors",
"--Compensation of Executive Officers", "--Compensation Arrangements and
Employment Agreements", "-- Report of the Compensation Committee", in the
Company's Proxy Statement with respect to the Annual Meeting of Shareholders to
be held on September 15, 1999.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT.
The information required under this item is incorporated herein by reference to
the section entitled "Principal Shareholders" in the Company's Proxy Statement
with respect to the Annual Meeting of Shareholders to be held on September 15,
1999.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS.
The information required under this item is incorporated herein by reference to
the sections entitled "Election of Directors -- Compensation Arrangements and
Employment Agreements" and "-- Certain Transactions" in the Company's Proxy
Statement with respect to the Annual Meeting of Shareholders to be held on
September 15, 1999.
PART IV
ITEM 14. EXHIBITS, FINANCIAL STATEMENT SCHEDULES AND REPORTS ON FORM 8-K.
(a) (1) INDEX TO FINANCIAL STATEMENTS.
The financial statements listed in the Index to Financial Statements are filed
as part of this Annual Report on Form 10-K.
(a) (2) INDEX TO FINANCIAL STATEMENT SCHEDULES.
All schedules are omitted because they are not applicable, or not required, or
because the required information is included in the financial statements or
notes thereto.
(a) (3) INDEX TO EXHIBITS.
53
<PAGE>
The Exhibits filed as part of this Form 10-K are listed on the Exhibit Index
immediately preceding such Exhibits.
(b) REPORTS ON FORM 8-K: On March 29, 1999, the Company filed a Form
8-K announcing the Company's completion of a $30 million debt
financing with John Hancock Mutual Life Insurance Company.
(c) EXHIBITS The response to this portion of Item 14 is submitted as a
separate section of this Form 10-K.
MANAGEMENT CONTRACTS AND OTHER COMPENSATORY ARRANGEMENTS. None
(d) FINANCIAL STATEMENT SCHEDULES. All schedules are omitted because
they are not applicable, or not required, or because the required
information is included in the financial statements or notes
thereto.
54
<PAGE>
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange
Act of 1934, the registrant has duly caused this report to be signed on its
behalf by the undersigned, thereunto duly authorized.
IGEN International, Inc.
June 25, 1999 By: /s/ Samuel J. Wohlstadter
--------------------------
Chief Executive Officer
KNOW ALL MEN BY THESE PRESENTS, that each person whose signature appears below
constitutes and appoints Samuel J. Wohlstadter, Richard J. Massey and George V.
Migausky as his attorney-in-fact for him in any and all capacities, to sign any
amendments to this report on Form 10-K, and to file the same, with exhibits
thereto and other documents in connection therewith, with the Securities and
Exchange Commission, hereby ratifying and confirming all that the said
attorney-in-fact, or his substitute or substitutes, may do or cause to be done
by virtue thereof.
Pursuant to the requirements of the Securities Exchange Act of 1934, this report
has been signed below by the following persons on behalf of the registrant and
in the capacities and on the dates indicated.
Signature Title Date
/s/ Samuel J. Wohlstadter Chief Executive Officer June 25, 1999
- ------------------------- (Principal Executive Officer);
Samuel J. Wohlstadter Director
/s/ George V. Migausky Vice President June 25, 1999
- ------------------------- and Chief Financial Officer
George V. Migausky (Principal Financial and
Accounting Officer)
/s/ Richard J. Massey President, Chief Operating June 25, 1999
- ------------------------- Officer; Director
Richard J. Massey
/s/ Edward Lurier Director June 25, 1999
- ------------------------
Edward Lurier
/s/ William O'Neill Director June 25, 1999
- ------------------------
William O'Neill
/s/ Robert Salsmans Director June 25, 1999
- ------------------------
Robert Salsmans
55
<PAGE>
INDEX TO EXHIBITS
<TABLE>
<CAPTION>
EXHIBIT
NUMBER DESCRIPTION OF DOCUMENT
- ------ -----------------------
<S> <C>
2.1(4) Agreement and Plan of Merger effective November 19, 1996 (by virtue of a
reincorporation), by and between IGEN, Inc., a California corporation (the "Company"),
and IGEN International, Inc. a Delaware corporation (the "Registrant").
3.1(4) The Registrant's Certificate of Incorporation, as filed with the Secretary of State of
the State of Delaware on August 30, 1996.
3.2(4) The Registrant's Certificate of Designation of Series A Junior Participating Preferred
Stock, as filed with the Secretary of State of the State of Delaware on November 18,
1996.
3.3(8) The Registrant's Certificate of Designation of Series B
Convertible Preferred Stock, as field with the Secretary of
State of the State of Delaware on December 18, 1997.
3.4(4) The Registrant's Bylaws, as currently in effect.
4.1(7) Form of Specimen Right Certificate.
4.2(7) Rights Agreement, dated November 6, 1996, between the Registrant and The First
National Bank of Boston.
4.3 Note Purchase Agreement between the Registrant and the purchasers named therein dated
as of March 22, 1999. Filed herewith.
10.1(1) Registration Agreement between the Registrant and the parties
named therein dated March 17, 1988, as amended through
March 30, 1993.
10.2(3) Form of Waiver and Amendment of Registration Agreement executed
in December 1993, amending in certain respects the Registration
Agreement dated as of March 17, 1988.
10.3(3) Agreement between the Registrant and The Perkin-Elmer Corporation
dated March 30, 1990, with Addendum to Agreement dated February 21,
1991 (with certain confidential information deleted).
10.4(3) Agreement between the Registrant and Eisai Co., Ltd. dated May 25,
1990 (with certain confidential information deleted).
10.4.1(1) Supplemental Agreement between Eisai Co., Ltd. and the Registrant
10.5(3) License and Development Technology Agreement between the Registrant
and Boehringer Mannheim GmbH dated September 23, 1992 (with
certain confidential information deleted).
10.5.1(2) Advanced Royalty Agreement between the Registrant and
Boehringer Mannheim GmbH dated January 9, 1997.
10.6(3) License Agreement between the Registrant and Hyperion Catalysis
International ("Hyperion") dated October 10, 1993 as amended March 15,
1990.
10.7(3) Common Stock Purchase Agreement between the Registrant and Organon
Teknika B.V. ("Organon") dated May 19, 1993.
</TABLE>
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<TABLE>
<CAPTION>
EXHIBIT
NUMBER DESCRIPTION OF DOCUMENT
- ------ -----------------------
<S> <C>
10.8(3) License and Technology Development agreement between the Registrant
and Organon dated May 19, 1993 (with certain confidential information
deleted).
10.9(3) Agreement and Plan of Reorganization and Agreement and Plan of Merger
between the Registrant and Molecular Displays, Inc. dated March 9, 1993.
10.103 Term Sheet for Consolidation of Research Projects between the Registrant and
Proteinix Corporation dated December 14, 1993 (with certain confidential
information deleted).
10.11(3) Term Sheet for consolidation of Cancer Research Projects between the
Registrant and Pro-Neuron, Inc. dated December 14, 1993 (with certain
confidential information deleted).
10.12(3) Join Venture Agreement between the Registrant and Hyperion dated
May 28, 1993.
10.13(3) Product Development and Marketing Agreement between the
Registrant, Hyperion and HyperGen dated May 29, 1993.
10.14(3) Form of Indemnity Agreement entered into between the Registrant and its
directors and officers.
10.15(3) Registrant's 1985 Stock Option Plan, as amended, and related Form of
Incentive Stock Option Grant and Form of Nonqualified Stock Option Grant.
10.16(5) Registrant's 1994 Stock Option Plan, and related Form of Incentive Stock
Option Grant.
10.17(5) Registrant's 1994 Non-Employee Directors Stock Option Plan, and related
Form of Incentive Stock Option Grant.
10.18(5) Lease Agreement between the Registrant and W-M 16020 Limited
Partnership dated October 5, 1994.
10.19(5) Agreement for Purchase and Sale of Joint Venture Interest
between the Registrant and Hyperion, dated December 28, 1994
10.20(6) Joint Venture Agreement, dated as of November 30, 1995, between Meso Scale
Diagnostics, LLC ("MSD"), Meso Scale Technologies, LLC ("MST")
and the Company.
10.21(6) Limited Liability Company Agreement, dated as of November 30, 1995, between MSD, MST
and the Company.
10.22(6) IGEN/MSD License Agreement, dated as of November 30, 1995, between MSD and the Company.
10.23(6) Indemnification Agreement, dated as of November 30, 1995, between the Company and
Jacob Wohlstadter.
10.24(8) Purchase Agreement for the Series B Convertible Preferred Stock between the Registrant
and the purchasers named therein dated as of December 16, 1997.
10.25(8) Registration Rights Agreement between the Registrant and the purchasers named therein
dated as of December 16, 1997.
11.1 Calculation of net loss per share. Filed herewith.
23.1 Consent of Deloitte & Touche LLP. Filed herewith.
</TABLE>
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<TABLE>
<CAPTION>
EXHIBIT
NUMBER DESCRIPTION OF DOCUMENT
- ------ -----------------------
<S> <C>
27.1 Financial Data Schedule. Filed herewith.
</TABLE>
- ------------
(1) Previously filed as an exhibit to the Registrant's Form 10-Q for the
quarter ended September 30, 1997.
(2) Previously filed as an exhibit to the Registrant's Annual Report on Form
10-K, as amended, for the fiscal year ended March 31, 1997.
(3) Previously filed as an exhibit to the Registration Statement on Form S-1,
as amended (Registration No. 33-72992) and incorporated by reference
herein.
(4) Previously filed as an exhibit to the Registrant's Form 10-Q for the
quarter ended December 31, 1996.
(5) Previously filed as an exhibit to the Registrant's Annual Report on Form
10-K for the fiscal year ended March 31, 1995.
(6) Previously filed as an exhibit to the Registrant's Form 10-Q for the
quarter ended December 31, 1995.
(7) Incorporated by reference to Exhibit 1.1 of the Registrant's Form 8-A
filed December 10, 1996.
(8) Previously filed as an exhibit to the Registrant's Registration Statement
on Form S-3, as amended (Registration No. 333-45355).
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EXHIBIT 4.3
- --------------------------------------------------------------------------------
- --------------------------------------------------------------------------------
IGEN INTERNATIONAL, INC.
$30,000,000
8.50% Senior Secured Notes due 2006
NOTE PURCHASE AGREEMENT
Dated as of March 22, 1999
- --------------------------------------------------------------------------------
- --------------------------------------------------------------------------------
<PAGE>
TABLE OF CONTENTS
<TABLE>
<CAPTION>
SECTION PAGE
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<S> <C> <C>
1. AUTHORIZATION OF NOTES....................................................1
2. SALE AND PURCHASE OF NOTES................................................1
3. CLOSING...................................................................2
4. CONDITIONS TO CLOSING.....................................................2
4.1. Representations and Warranties......................................2
4.2. Performance; No Default.............................................2
4.3. Compliance Certificates.............................................2
4.4. Opinions of Counsel.................................................3
4.5. Purchase Permitted By Applicable Law, etc...........................3
4.6. Sale of Other Notes.................................................3
4.7. Payment of Special Counsel Fees and Other Fees......................3
4.8. Private Placement Number............................................4
4.9. Changes in Corporate Structure......................................4
4.10. Financing Documents; Security Interests.............................4
4.11. Lien Searches.......................................................4
4.12. License Agreement...................................................4
4.13. BMG Payment Letter..................................................4
4.14. Proceedings and Documents...........................................4
5. REPRESENTATIONS AND WARRANTIES OF THE COMPANY.............................5
5.1. Organization; Power and Authority...................................5
5.2. Authorization, etc..................................................5
5.3. Disclosure..........................................................5
5.4. Organization and Ownership of Shares of Subsidiaries; Affiliates....6
5.5. Financial Statements................................................6
5.6. Compliance with Laws, Other Instruments, etc........................7
5.7. Governmental Authorizations, etc....................................7
5.8. Litigation; Observance of Agreements, Statutes and Orders...........7
5.9. Taxes...............................................................7
5.10. Title to Property; Leases...........................................8
5.11. Licenses, Permits, etc..............................................8
5.12. Compliance with ERISA...............................................8
5.13. Private Offering by the Company.....................................9
5.14. Use of Proceeds; Margin Regulations................................10
5.15. Existing Indebtedness; Future Liens................................10
5.16. Foreign Assets Control Regulations, etc............................10
5.17. Status under Certain Statutes......................................10
5.18. Environmental Matters..............................................11
5.19. Ownership; Security Documents......................................11
5.20. License Agreement..................................................12
5.21. Chief Executive Office.............................................12
</TABLE>
i
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<TABLE>
<S> <C>
5.22. Year 2000..........................................................12
6. REPRESENTATIONS OF THE PURCHASER.........................................12
6.1. Purchase for Investment............................................12
6.2. Source of Funds....................................................12
7. INFORMATION AS TO COMPANY................................................14
7.1. Financial and Business Information.................................14
7.2. Officer's Certificate..............................................16
7.3. Inspection.........................................................17
8. PAYMENT OF THE NOTES.....................................................17
8.1. Required Payments..................................................17
8.2. Optional Prepayments with Make-Whole Amount........................18
8.3. Allocation of Partial Prepayments..................................18
8.4. Maturity; Surrender, etc...........................................18
8.5. Purchase of Notes..................................................19
8.6. Make-Whole Amount..................................................19
9. AFFIRMATIVE COVENANTS....................................................20
9.1. Compliance with Law................................................20
9.2. Insurance..........................................................21
9.3. Maintenance of Properties..........................................21
9.4. Payment of Taxes and Claims........................................21
9.5. Corporate Existence, etc...........................................21
9.6. Further Assurances.................................................22
9.7. License Agreement..................................................22
10. NEGATIVE COVENANTS.......................................................22
10.1. Transactions with Affiliates.......................................22
10.2. Merger, Consolidation, etc.........................................22
10.3. Liens..............................................................23
10.4. Amendments to License Agreement....................................23
10.5. Royalty Payment Coverage Ratio.....................................23
10.6. Incurrence of Secured Indebtedness.................................24
11. EVENTS OF DEFAULT........................................................24
12. REMEDIES ON DEFAULT, ETC.................................................26
12.1. Acceleration.......................................................26
12.2. Other Remedies.....................................................27
12.3. Rescission.........................................................27
12.4. No Waivers or Election of Remedies, Expenses, etc..................28
13. REGISTRATION; EXCHANGE; SUBSTITUTION OF NOTES............................28
13.1. Registration of Notes..............................................28
13.2. Transfer and Exchange of Notes.....................................28
13.3. Replacement of Notes...............................................29
14. PAYMENTS ON NOTES........................................................29
14.1. Place of Payment...................................................29
14.2. Home Office Payment................................................29
15. EXPENSES, ETC............................................................30
15.1. Transaction Expenses...............................................30
15.2. Survival...........................................................30
</TABLE>
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<TABLE>
<S> <C>
16. SURVIVAL OF REPRESENTATIONS AND WARRANTIES; ENTIRE AGREEMENT.............30
17. AMENDMENT AND WAIVER.....................................................31
17.1. Requirements.......................................................31
17.2. Solicitation of Holders of Notes...................................31
17.3. Binding Effect, etc................................................32
17.4. Notes held by Company, etc.........................................32
18. NOTICES..................................................................32
19. REPRODUCTION OF DOCUMENTS................................................33
20. CONFIDENTIAL INFORMATION.................................................33
21. SUBSTITUTION OF PURCHASER................................................34
22. MISCELLANEOUS............................................................34
22.1. Successors and Assigns.............................................34
22.2. Payments Due on Non-Business Days..................................34
22.3. Severability.......................................................35
22.4. Construction.......................................................35
22.5. Counterparts.......................................................35
22.6. Governing Law......................................................35
</TABLE>
<TABLE>
<S> <C> <C>
SCHEDULE A -- INFORMATION RELATING TO PURCHASERS
SCHEDULE B -- DEFINED TERMS
SCHEDULE 4.9 -- Changes in Corporate Structure
SCHEDULE 4.10 -- Filings and Recordings
SCHEDULE 5.4 -- Subsidiaries of the Company and
Ownership of Subsidiary Stock
SCHEDULE 5.5 -- Financial Statements
SCHEDULE 5.11 -- Patents, etc.
SCHEDULE 5.14 -- Use of Proceeds
SCHEDULE 5.15 -- Existing Indebtedness
SCHEDULE 8.1 -- Amortization of the Notes
EXHIBIT 1 -- Form of 8.50% Senior Secured Note due 2006
EXHIBIT 2 -- Form of Security Agreement
</TABLE>
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<TABLE>
<S> <C> <C>
EXHIBIT 4.4(a) -- Form of Opinion of Special Counsel for the
Company
EXHIBIT 4.4(b) -- Form of Opinion of Special Counsel
for the Purchasers
</TABLE>
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IGEN INTERNATIONAL, INC.
16020 Industrial Drive
Gaithersburg, MD 20877
8.50% Senior Secured Notes due 2006
as of March 22, 1999
TO EACH OF THE PURCHASERS LISTED IN
THE ATTACHED SCHEDULE A:
Ladies and Gentlemen:
IGEN INTERNATIONAL, INC., a Delaware corporation (the "COMPANY"), agrees with
you as follows:
AUTHORIZATION OF NOTES.
The Company will authorize the issue and sale of $30,000,000 aggregate principal
amount of its 8.50% Senior Secured Notes due 2006 (the "NOTES", such term to
include any such notes issued in substitution therefor pursuant to Section 13 of
this Agreement or the Other Agreements (as hereinafter defined)). The Notes
shall be substantially in the form set out in Exhibit 1, with such changes
therefrom, if any, as may be approved by you and the Company. Certain
capitalized terms used in this Agreement are defined in Schedule B; references
to a "Schedule" or an "Exhibit" are, unless otherwise specified, to a Schedule
or an Exhibit attached to this Agreement. The Notes will be secured by the
Collateral, all as provided in the Security Agreement.
SALE AND PURCHASE OF NOTES.
Subject to the terms and conditions of this Agreement, the Company will issue
and sell to you and you will purchase from the Company, at the Closing provided
for in Section 3, Notes in the principal amount specified opposite your name in
Schedule A at the purchase price of 100% of the principal amount thereof.
Contemporaneously with entering into this Agreement, the Company is entering
into separate Note Purchase Agreements (the "OTHER AGREEMENTS") identical with
this Agreement with each of the other purchasers named in Schedule A (the "OTHER
PURCHASERS"), providing for the sale at such Closing to each of the Other
Purchasers of Notes in the principal amount specified opposite its name in
Schedule A. Your obligation hereunder and the obligations of the Other
Purchasers under the Other Agreements are several and not joint obligations and
you shall have no obligation under any Other Agreement and no liability to any
Person for the performance or non-performance by any Other Purchaser thereunder.
1
<PAGE>
CLOSING.
The sale and purchase of the Notes to be purchased by you and the Other
Purchasers shall occur at the offices of Milbank, Tweed, Hadley & McCloy LLP,
One Chase Manhattan Plaza, New York, New York 10005, at 10:00 a.m., New York
City time, at a closing (the "CLOSING") on March 22, 1999 or on such other
Business Day thereafter on or prior to March 31, 1999 as may be agreed upon by
the Company and you and the Other Purchasers. At the Closing the Company will
deliver to you the Notes to be purchased by you in the form of a single Note (or
such greater number of Notes in denominations of at least $1,000,000 as you may
request) dated the date of the Closing and registered in your name (or in the
name of your nominee), against delivery by you to the Company or its order of
immediately available funds in the amount of the purchase price therefor by wire
transfer of immediately available funds for the account of the Company to
account number 2000007114036 at First Union National Bank of Maryland,
Rockville, Maryland 20852, ABA number 055-003-201, Reference: for further credit
to IGEN International Inc. If at the Closing the Company shall fail to tender
such Notes to you as provided above in this Section 3, or any of the conditions
specified in Section 4 shall not have been fulfilled to your satisfaction, you
shall, at your election, be relieved of all further obligations under this
Agreement, without thereby waiving any rights you may have by reason of such
failure or such nonfulfillment.
CONDITIONS TO CLOSING.
Your obligation to purchase and pay for the Notes to be sold to you at the
Closing is subject to the fulfillment to your satisfaction, prior to or at the
Closing, of the following conditions:
REPRESENTATIONS AND WARRANTIES.
The representations and warranties of the Company in each Financing Document
shall be correct when made and at the time of the Closing.
PERFORMANCE; NO DEFAULT.
The Company shall have performed and complied with all agreements and conditions
contained in each Financing Document required to be performed or complied with
by it prior to or at the Closing and after giving effect to the issue and sale
of the Notes (and the application of the proceeds thereof as contemplated by
Schedule 5.14) no Default or Event of Default shall have occurred and be
continuing. Neither the Company nor any Subsidiary shall have entered into any
transaction since December 31, 1998, that would have been prohibited by Section
10.1 or 10.6 hereof had such Sections applied since such date.
COMPLIANCE CERTIFICATES.
(a) OFFICER'S CERTIFICATE. The Company shall have delivered to you an
Officer's Certificate, dated the date of the Closing, certifying that the
conditions specified in Sections 4.1, 4.2, 4.9 and 4.12 have been fulfilled.
2
<PAGE>
(b) SECRETARY'S CERTIFICATE. The Company shall have delivered to you a
certificate certifying as to the resolutions attached thereto and other
corporate proceedings relating to the authorization, execution and delivery
of the Notes, this Agreement, the Other Agreements and the other Financing
Documents.
OPINIONS OF COUNSEL.
You shall have received opinions in form and substance satisfactory to you,
dated the date of the Closing (A) from Cooley Godward LLP, counsel for the
Company, covering the matters set forth in Exhibit 4.4(a) and covering such
other matters incident to the transactions contemplated hereby as you or your
counsel may reasonably request (and the Company hereby instructs its counsel to
deliver such opinion to you) and (B) from Milbank, Tweed, Hadley & McCloy LLP,
your special counsel in connection with such transactions, substantially in the
form set forth in Exhibit 4.4(b) and covering such other matters incident to
such transactions as you may reasonably request.
PURCHASE PERMITTED BY APPLICABLE LAW, ETC.
On the date of the Closing your purchase of Notes shall (I) be permitted by the
laws and regulations of each jurisdiction to which you are subject, without
recourse to provisions (such as Section 1405(a)(8) of the New York Insurance
Law) permitting limited investments by insurance companies without restriction
as to the character of the particular investment, (II) not violate any
applicable law or regulation (including, without limitation, Regulation T, U or
X of the Board of Governors of the Federal Reserve System) and (III) not subject
you to any tax, penalty or liability under or pursuant to any applicable law or
regulation, which law or regulation was not in effect on the date hereof. If
requested by you, you shall have received an Officer's Certificate certifying as
to such matters of fact as you may reasonably specify to enable you to determine
whether such purchase is so permitted.
SALE OF OTHER NOTES.
Contemporaneously with the Closing the Company shall sell to the Other
Purchasers and the Other Purchasers shall purchase the Notes to be purchased by
them at the Closing as specified in Schedule A.
PAYMENT OF SPECIAL COUNSEL FEES AND OTHER FEES.
Without limiting the provisions of Section 15.1, the Company shall have paid on
or before the Closing any fees due and owing to the Collateral Agent and shall
have paid the fees, charges and disbursements of your special counsel referred
to in Section 4.4 to the extent reflected in a statement of such counsel
rendered to the Company at least one Business Day prior to the Closing. In
addition, all taxes due in connection with the preparation, execution, delivery,
filing, recordation, registration and notarization of any Financing Document or
any document furnished under or in connection with any Financing Document shall
have been paid in full by the Company and you shall have received evidence
thereof reasonably satisfactory to you.
3
<PAGE>
PRIVATE PLACEMENT NUMBER.
A Private Placement number issued by Standard & Poor's CUSIP Service Bureau (in
cooperation with the Securities Valuation Office of the National Association of
Insurance Commissioners) shall have been obtained for the Notes.
CHANGES IN CORPORATE STRUCTURE.
Except as specified in Schedule 4.9, the Company shall not have changed its
jurisdiction of incorporation or been a party to any merger or consolidation and
shall not have succeeded to all or any substantial part of the liabilities of
any other entity, at any time following the date of the most recent financial
statements referred to in Schedule 5.5.
FINANCING DOCUMENTS; SECURITY INTERESTS.
This Agreement and each other Financing Document shall have been duly executed
and delivered by each of the parties hereto and thereto and shall be in full
force and effect. In addition, you shall have received evidence reasonably
satisfactory to you that the Company shall have taken all actions (including,
without limitation, the making of all recordings and filings set forth in
Schedule 4.10) as may be necessary or appropriate in order to create and perfect
the security interests intended to be created pursuant to the Security Agreement
as first priority Liens.
LIEN SEARCHES.
The Company shall have delivered to you the results of a recent search, by a
Person reasonably satisfactory to you, of the Uniform Commercial Code filings
and tax and judgment Liens which may have been filed with respect to the
personal property of the Company in such filing offices as you may reasonably
request.
LICENSE AGREEMENT.
True and complete copies (including any amendments thereto) of the License
Agreement shall have been delivered to you and the Other Purchasers and the
License Agreement shall be in full force and effect.
BMG PAYMENT LETTER.
The Company shall have delivered to you, in form and substance satisfactory to
you, a letter from the Company to BMG directing BMG to make all Royalty Payments
directly to the Collection Account.
PROCEEDINGS AND DOCUMENTS.
All corporate and other proceedings in connection with the transactions
contemplated by the Financing Documents and all documents and instruments
incident to such transactions shall be satisfactory to you and your special
counsel, and you and your special counsel shall have received
4
<PAGE>
all such counterpart originals or certified or other copies of such documents as
you or they may reasonably request.
REPRESENTATIONS AND WARRANTIES OF THE COMPANY.
The Company represents and warrants to you that:
ORGANIZATION; POWER AND AUTHORITY.
The Company is a corporation duly organized, validly existing and in good
standing under the laws of its jurisdiction of incorporation, and is duly
qualified as a foreign corporation and is in good standing in each jurisdiction
in which such qualification is required by law, other than those jurisdictions
as to which the failure to be so qualified or in good standing could not,
individually or in the aggregate, reasonably be expected to have a Material
Adverse Effect. The Company has the corporate power and authority to own or hold
under lease the properties it purports to own or hold under lease, to transact
the business it transacts and proposes to transact, to execute and deliver this
Agreement, the Notes and each other Financing Document and to perform the
provisions hereof and thereof.
AUTHORIZATION, ETC.
This Agreement, the Notes and each Other Financing Document have been duly
authorized by all necessary corporate action on the part of the Company, and
this Agreement constitutes, and upon execution and delivery thereof each Note
and each other Financing Document will constitute, a legal, valid and binding
obligation of the Company enforceable against the Company in accordance with its
terms, except as such enforceability may be limited by (I) applicable
bankruptcy, insolvency, reorganization, moratorium or other similar laws
affecting the enforcement of creditors' rights generally and (II) general
principles of equity (regardless of whether such enforceability is considered in
a proceeding in equity or at law).
DISCLOSURE.
The Company, through its agent, ING Baring Furman Selz LLC, has delivered to you
and each Other Purchaser a copy of (i) an Information Memorandum, dated
December, 1998 (the "MEMORANDUM"), relating to the transactions contemplated
hereby and (ii) its Annual Report on Form 10-K for its fiscal year ended March
31, 1998 and its Quarterly Reports on Form 10-Q for the fiscal quarters ended
June 30, 1998, September 30, 1998 and December 31, 1998 (collectively, the "SEC
REPORTS"). The Memorandum and the SEC Reports, taken as a whole, fairly
describe, in all material respects, the general nature of the business and
principal properties of the Company and its Subsidiaries. This Agreement, the
other Financing Documents, the Memorandum, the SEC Reports, the documents,
certificates or other writings delivered to you by or on behalf of the Company
in connection with the transactions contemplated hereby and the financial
statements listed in Schedule 5.5, taken as a whole, do not contain any untrue
statement of a material fact or omit to state any material fact necessary to
make the statements therein not misleading in light of the circumstances under
which they were made. Except as disclosed in the Memorandum or as
5
<PAGE>
expressly described in the SEC Reports, or in one of the documents, certificates
or other writings identified therein, or in the financial statements listed in
Schedule 5.5, since December 31, 1998, there has been no change in the financial
condition, operations, business, properties or prospects of the Company or any
Subsidiary except changes that individually or in the aggregate could not
reasonably be expected to have a Material Adverse Effect. There is no fact known
to the Company that could reasonably be expected to have a Material Adverse
Effect that has not been set forth herein or in the Memorandum or in the other
documents, certificates and other writings delivered to you by or on behalf of
the Company specifically for use in connection with the transactions
contemplated hereby.
ORGANIZATION AND OWNERSHIP OF SHARES OF SUBSIDIARIES; AFFILIATES.
(a) Schedule 5.4 contains (except as noted therein) complete and
correct lists (I) of the Company's Subsidiaries, showing, as to each
Subsidiary, the correct name thereof, the jurisdiction of its organization,
and the percentage of shares of each class of its capital stock or similar
equity interests outstanding owned by the Company and each other Subsidiary,
(II) of the Company's Affiliates, other than Subsidiaries, and (III) of the
Company's directors and senior officers.
(b) All of the outstanding shares of capital stock or similar equity
interests of each Subsidiary shown in Schedule 5.4 as being owned by the
Company and its Subsidiaries have been validly issued, are fully paid and
nonassessable and are owned by the Company or another Subsidiary free and
clear of any Lien (except as otherwise disclosed in Schedule 5.4).
(c) Each Subsidiary identified in Schedule 5.4 is a corporation or
other legal entity duly organized, validly existing and in good standing
under the laws of its jurisdiction of organization, and is duly qualified as
a foreign corporation or other legal entity and is in good standing in each
jurisdiction in which such qualification is required by law, other than
those jurisdictions as to which the failure to be so qualified or in good
standing could not, individually or in the aggregate, reasonably be expected
to have a Material Adverse Effect. Each such Subsidiary has the corporate or
other power and authority to own or hold under lease the properties it
purports to own or hold under lease and to transact the business it
transacts and proposes to transact.
(d) No Subsidiary is a party to, or otherwise subject to any legal
restriction or any agreement (other than this Agreement, the agreements
listed on Schedule 5.4 and customary limitations imposed by corporate law
statutes) restricting the ability of such Subsidiary to pay dividends out of
profits or make any other similar distributions of profits to the Company or
any of its Subsidiaries that owns outstanding shares of capital stock or
similar equity interests of such Subsidiary.
FINANCIAL STATEMENTS.
The Company has delivered to each Purchaser copies of the financial statements
of the Company and its Subsidiaries listed on Schedule 5.5. All of said
financial statements (including in each case the related schedules and notes)
fairly present in all material respects the consolidated financial position of
the Company and its Subsidiaries as of the respective dates specified in such
Schedule
6
<PAGE>
and the consolidated results of their operations and cash flows for the
respective periods so specified and have been prepared in accordance with GAAP
consistently applied throughout the periods involved except as set forth in the
notes thereto (subject, in the case of any interim financial statements, to
normal year-end adjustments).
COMPLIANCE WITH LAWS, OTHER INSTRUMENTS, ETC.
The execution, delivery and performance by the Company of this Agreement, the
Notes and the other Financing Documents will not (I) contravene, result in any
breach of, or constitute a default under, or result in the creation of any Lien
(other than the Lien of the Security Agreement) in respect of any property of
the Company or any Subsidiary under, any indenture, mortgage, deed of trust,
loan, purchase or credit agreement, lease, corporate charter or by-laws, or any
other agreement or instrument to which the Company or any Subsidiary is bound or
by which the Company or any Subsidiary or any of their respective properties may
be bound or affected, (II) conflict with or result in a breach of any of the
terms, conditions or provisions of any order, judgment, decree, or ruling of any
court, arbitrator or Governmental Authority applicable to the Company or any
Subsidiary or (III) violate any provision of any statute or other rule or
regulation of any Governmental Authority applicable to the Company or any
Subsidiary.
GOVERNMENTAL AUTHORIZATIONS, ETC.
No consent, approval or authorization of, or registration, filing or declaration
with, any Governmental Authority is required in connection with the execution,
delivery or performance by the Company of this Agreement, the Notes or any other
Financing Document.
LITIGATION; OBSERVANCE OF AGREEMENTS, STATUTES AND ORDERS.
(a) There are no actions, suits or proceedings pending or, to the
knowledge of the Company, threatened against or affecting the Company or any
Subsidiary or any property of the Company or any Subsidiary in any court or
before any arbitrator of any kind or before or by any Governmental Authority
that, individually or in the aggregate, could reasonably be expected to have
a Material Adverse Effect.
(b) Neither the Company nor any Subsidiary is in default under any
term of any agreement or instrument to which it is a party or by which it is
bound, or any order, judgment, decree or ruling of any court, arbitrator or
Governmental Authority or is in violation of any applicable law, ordinance,
rule or regulation (including without limitation Environmental Laws) of any
Governmental Authority, which default or violation, individually or in the
aggregate, could reasonably be expected to have a Material Adverse Effect.
TAXES.
The Company and its Subsidiaries have filed all tax returns that are required to
have been filed in any jurisdiction, and have paid all taxes shown to be due and
payable on such returns and all other taxes and assessments levied upon them or
their properties, assets, income or franchises, to the
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extent such taxes and assessments have become due and payable and before they
have become delinquent, except for any taxes and assessments (I) the amount of
which is not individually or in the aggregate Material or (II) the amount,
applicability or validity of which is currently being contested in good faith by
appropriate proceedings and with respect to which the Company or a Subsidiary,
as the case may be, has established adequate reserves in accordance with GAAP.
The Company knows of no basis for any other tax or assessment that could
reasonably be expected to have a Material Adverse Effect. The charges, accruals
and reserves on the books of the Company and its Subsidiaries in respect of
Federal, state or other taxes for all fiscal periods are adequate. The Federal
income tax liabilities of the Company and its Subsidiaries have been determined
by the Internal Revenue Service and paid for all fiscal years up to and
including the fiscal year ended March 31, 1998.
TITLE TO PROPERTY; LEASES.
The Company and its Subsidiaries have good and sufficient title to their
respective properties that individually or in the aggregate are Material,
including all such properties reflected in the most recent audited balance sheet
referred to in Section 5.5 or purported to have been acquired by the Company or
any Subsidiary after said date (except as sold or otherwise disposed of in the
ordinary course of business), in each case free and clear of Liens prohibited by
this Agreement or any other Financing Document. All leases that individually or
in the aggregate are Material are valid and subsisting and are in full force and
effect in all material respects.
LICENSES, PERMITS, ETC.
Except as disclosed in Schedule 5.11,
(a) The Company and its Subsidiaries own or possess all licenses,
permits, franchises, authorizations, patents, copyrights, service marks,
trademarks and trade names, or rights thereto, that individually or in the
aggregate are Material, without known conflict with the rights of others;
(b) To the best knowledge of the Company, no product of the Company
infringes in any material respect any license, permit, franchise,
authorization, patent, copyright, service mark, trademark, trade name or
other right owned by any other Person; and
(c) To the best knowledge of the Company, there is no Material
violation by any Person of any right of the Company or any of its
Subsidiaries with respect to any patent, copyright, service mark, trademark,
trade name or other right owned or used by the Company or any of its
Subsidiaries.
COMPLIANCE WITH ERISA.
(a) The Company and each ERISA Affiliate have operated and
administered each Plan in compliance with all applicable laws except for
such instances of noncompliance as have not resulted in and could not
reasonably be expected to result in a Material Adverse Effect. Neither the
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Company nor any ERISA Affiliate has incurred any liability pursuant to Title
I or IV of ERISA or the penalty or excise tax provisions of the Code
relating to employee benefit plans (as defined in section 3 of ERISA), and
no event, transaction or condition has occurred or exists that could
reasonably be expected to result in the incurrence of any such liability by
the Company or any ERISA Affiliate, or in the imposition of any Lien on any
of the rights, properties or assets of the Company or any ERISA Affiliate,
in either case pursuant to Title I or IV of ERISA or to such penalty or
excise tax provisions or to section 401(a)(29) or 412 of the Code, other
than such liabilities or Liens as would not be individually or in the
aggregate Material.
(b) The present value of the aggregate benefit liabilities under each
of the Plans (other than Multiemployer Plans), determined as of the end of
such Plan's most recently ended plan year on the basis of the actuarial
assumptions specified for funding purposes in such Plan's most recent
actuarial valuation report, did not exceed the aggregate current value of
the assets of such Plan allocable to such benefit liabilities. The term
"BENEFIT LIABILITIES" has the meaning specified in section 4001 of ERISA and
the terms "CURRENT VALUE" and "PRESENT VALUE" have the meaning specified in
section 3 of ERISA.
(c) The Company and its ERISA Affiliates have not incurred withdrawal
liabilities (and are not subject to contingent withdrawal liabilities) under
section 4201 or 4204 of ERISA in respect of Multiemployer Plans that
individually or in the aggregate are Material.
(d) The expected postretirement benefit obligation (determined as of
the last day of the Company's most recently ended fiscal year in accordance
with Financial Accounting Standards Board Statement No. 106, without regard
to liabilities attributable to continuation coverage mandated by section
4980B of the Code) of the Company and its Subsidiaries is not Material.
(e) The execution and delivery of this Agreement and the issuance and
sale of the Notes hereunder will not involve any transaction that is subject
to the prohibitions of section 406 of ERISA or in connection with which a
tax could be imposed pursuant to section 4975(c)(1)(A)-(D) of the Code. The
representation by the Company in the first sentence of this Section 5.12(e)
is made in reliance upon and subject to (I) the accuracy of your
representation in Section 6.2 as to the sources of the funds used to pay the
purchase price of the Notes to be purchased by you and (II) the assumption,
made solely for the purpose of making such representation, that Department
of Labor Interpretive Bulletin 75-2 with respect to prohibited transactions
remains valid in the circumstances of the transactions contemplated herein.
PRIVATE OFFERING BY THE COMPANY.
Neither the Company nor anyone acting on its behalf has offered the Notes or any
similar securities for sale to, or solicited any offer to buy any of the same
from, or otherwise approached or negotiated in respect thereof with, any person
other than you, the Other Purchasers and not more than 12 other Institutional
Investors, each of which has been offered the Notes at a private sale for
investment. Neither the Company nor anyone acting on its behalf has taken, or
will take, any action that would subject the issuance or sale of the Notes to
the registration requirements of Section 5 of the Securities Act.
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USE OF PROCEEDS; MARGIN REGULATIONS.
The Company will apply the proceeds of the sale of the Notes as set forth in
Schedule 5.14. No part of the proceeds from the sale of the Notes hereunder will
be used, directly or indirectly, for the purpose of buying or carrying any
margin stock within the meaning of Regulation U of the Board of Governors of the
Federal Reserve System (12 CFR 221), or for the purpose of buying or carrying or
trading in any securities under such circumstances as to involve the Company in
a violation of Regulation X of said Board (12 CFR 224) or to involve any broker
or dealer in a violation of Regulation T of said Board (12 CFR 220). Margin
stock does not constitute more than 5% of the value of the consolidated assets
of the Company and its Subsidiaries and the Company does not have any present
intention that margin stock will constitute more than 5% of the value of such
assets. As used in this Section, the terms "MARGIN STOCK" and "PURPOSE OF BUYING
OR CARRYING" shall have the meanings assigned to them in said Regulation U.
EXISTING INDEBTEDNESS; FUTURE LIENS.
(a) Except as described therein, Schedule 5.15 sets forth a complete
and correct list of all outstanding Indebtedness of the Company and its
Subsidiaries as of December 31, 1998, since which date there has been no
Material change in the amounts, interest rates, sinking funds, installment
payments or maturities of the Indebtedness of the Company or its
Subsidiaries. Neither the Company nor any Subsidiary is in default and no
waiver of default is currently in effect, in the payment of any principal or
interest on any Indebtedness of the Company or such Subsidiary and no event
or condition exists with respect to any Indebtedness of the Company or any
Subsidiary that would permit (or that with notice or the lapse of time, or
both, would permit) one or more Persons to cause such Indebtedness to become
due and payable before its stated maturity or before its regularly scheduled
dates of payment.
(b) Neither the Company nor any Subsidiary has agreed or consented to
cause or permit in the future (upon the happening of a contingency or
otherwise) any of its property, whether now owned or hereafter acquired, to
be subject to a Lien.
FOREIGN ASSETS CONTROL REGULATIONS, ETC.
Neither the sale of the Notes by the Company hereunder nor its use of the
proceeds thereof will violate the Trading with the Enemy Act, as amended, or any
of the foreign assets control regulations of the United States Treasury
Department (31 CFR, Subtitle B, Chapter V, as amended) or any enabling
legislation or executive order relating thereto.
STATUS UNDER CERTAIN STATUTES.
Neither the Company nor any Subsidiary is subject to regulation under the
Investment Company Act of 1940, as amended, the Public Utility Holding Company
Act of 1935, as amended, the Interstate Commerce Act, as amended, or the Federal
Power Act, as amended.
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ENVIRONMENTAL MATTERS.
Neither the Company nor any Subsidiary has knowledge of any claim or has
received any notice of any claim, and no proceeding has been instituted raising
any claim against the Company or any of its Subsidiaries or any of their
respective real properties now or formerly owned, leased or operated by any of
them or other assets, alleging any damage to the environment or violation of any
Environmental Laws, except, in each case, such as could not reasonably be
expected to result in a Material Adverse Effect. Except as otherwise disclosed
to you in writing,
(a) neither the Company nor any Subsidiary has knowledge of any facts
which would give rise to any claim, public or private, of violation of
Environmental Laws or damage to the environment emanating from, occurring on
or in any way related to real properties now or formerly owned, leased or
operated by any of them or to other assets or their use, except, in each
case, such as could not reasonably be expected to result in a Material
Adverse Effect;
(b) neither the Company nor any of its Subsidiaries has stored any
Hazardous Materials on real properties now or formerly owned, leased or
operated by any of them and has not disposed of any Hazardous Materials in a
manner contrary to any Environmental Laws in each case in any manner that
could reasonably be expected to result in a Material Adverse Effect; and
(c) all buildings on all real properties now owned, leased or operated
by the Company or any of its Subsidiaries are in compliance with applicable
Environmental Laws, except where failure to comply could not reasonably be
expected to result in a Material Adverse Effect.
OWNERSHIP; SECURITY DOCUMENTS.
The Company is the sole and beneficial owner of the Collateral and no Lien
exists or will exist upon such Collateral at any time, except for the security
interest in favor of the Collateral Agent for the benefit of the Secured Parties
created or provided for in the Security Agreement. The provisions of the
Security Agreement are effective to create, in favor of the Collateral Agent on
behalf of the Secured Parties, legal, valid and enforceable Liens on or in all
of the Collateral intended to be covered thereby, and as of the date of the
Closing all necessary recordings and filings will have been made in all
necessary public offices (such recordings and filings being identified on
Schedule 4.10) and all other necessary and appropriate action will have been
taken so that the Liens created by the Security Agreement will constitute
perfected Liens on or in the Collateral intended to be covered thereby, prior
and superior to all other Liens, and all necessary consents, if any, to the
creation, effectiveness, priority and perfection of each such Lien have been
obtained. No mortgage or financing statement or other instrument or recordation
covering all or any part of the Collateral is on file in any recording office,
except such as may have been filed in favor of the Collateral Agent for the
benefit of the Secured Parties.
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LICENSE AGREEMENT.
The Company is not in default under the License Agreement. The License Agreement
constitutes a legal, valid and binding obligation of each party thereof,
enforceable against such party in accordance with its terms, except as such
enforceability may be limited by (I) applicable bankruptcy, insolvency,
reorganization, moratorium or other similar laws affecting the enforcement of
creditors' rights generally and (II) general principles of equity (regardless of
whether such enforceability is considered in a proceeding in equity or at law)
and, except as disclosed in the Memorandum or the SEC Reports, no other party is
in default under the License Agreement.
CHIEF EXECUTIVE OFFICE.
The chief place of business and chief executive office of the Company, and the
office where the Company keeps its records concerning the Collateral (herein
collectively called the "Records") and the original copies of the License
Agreement, is 16020 Industrial Drive, Gaithersburg, MD 20877.
YEAR 2000.
The Company and each of its Subsidiaries has adopted a plan (the "YEAR 2000
PLAN") which adequately addresses, in the reasonable judgment of senior
management of the Company, the operational and financial issues ("YEAR 2000
ISSUES") arising from data in the management information and computer systems of
the Company and its Subsidiaries respecting dates prior to, on or after January
1, 2000. The Year 2000 Plan is in process of implementation and, as a result
thereof, Year 2000 Issues do not present a reasonable likelihood of resulting in
a Material Adverse Effect.
REPRESENTATIONS OF THE PURCHASER.
PURCHASE FOR INVESTMENT.
You represent that you are purchasing the Notes for your own account or for one
or more separate accounts maintained by you or for the account of one or more
pension or trust funds and not with a view to the distribution thereof, PROVIDED
that the disposition of your or their property shall at all times be within your
or their control. You understand that the Notes have not been registered under
the Securities Act and may be resold only if registered pursuant to the
provisions of the Securities Act or if an exemption from registration is
available, except under circumstances where neither such registration nor such
an exemption is required by law, and that the Company is not required to
register the Notes.
SOURCE OF FUNDS.
You represent that at least one of the following statements is an accurate
representation as to each source of funds (a "Source") to be used by you to pay
the purchase price of the Notes to be purchased by you hereunder:
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(a) if you are an insurance company, the Source does not include
assets allocated to any separate account maintained by you in which any
employee benefit plan (or its related trust) has any interest, other than a
separate account that is maintained solely in connection with your fixed
contractual obligations under which the amounts payable, or credited, to
such plan and to any participant or beneficiary of such plan (including any
annuitant) are not affected in any manner by the investment performance of
the separate account; or
(b) the Source is either (i) an insurance company pooled separate
account, within the meaning of Prohibited Transaction Exemption ("PTE") 90-1
(issued January 29, 1990), or (ii) a bank collective investment fund, within
the meaning of the PTE 91-38 (issued July 12, 1991) and, except as you have
disclosed to the Company in writing pursuant to this paragraph (b), no
employee benefit plan or group of plans maintained by the same employer or
employee organization beneficially owns more than 10% of all assets
allocated to such pooled separate account or collective investment fund; or
(c) the Source constitutes assets of an "investment fund" (within the
meaning of Part V of the QPAM Exemption) managed by a "qualified
professional asset manager" or "QPAM" (within the meaning of Part V of the
QPAM Exemption), no employee benefit plan's assets that are included in such
investment fund, when combined with the assets of all other employee benefit
plans established or maintained by the same employer or by an affiliate
(within the meaning of Section V(c)(1) of the QPAM Exemption) of such
employer or by the same employee organization and managed by such QPAM,
exceed 20% of the total client assets managed by such QPAM, the conditions
of Part I(c) and (g) of the QPAM Exemption are satisfied, neither the QPAM
nor a person controlling or controlled by the QPAM (applying the definition
of "control" in Section V(e) of the QPAM Exemption) owns a 5% or more
interest in the Company and (I) the identity of such QPAM and (II) the names
of all employee benefit plans whose assets are included in such investment
fund have been disclosed to the Company in writing pursuant to this
paragraph (c); or
(d) the Source is a governmental plan; or
(e) the Source is one or more employee benefit plans, or a separate
account or trust fund comprised of one or more employee benefit plans, each
of which has been identified to the Company in writing pursuant to this
paragraph (e); or
(f) the Source does not include assets of any employee benefit plan,
other than a plan exempt from the coverage of ERISA.
As used in this Section 6.2, the terms "EMPLOYEE BENEFIT PLAN" and "SEPARATE
ACCOUNT" shall have the respective meanings assigned to such terms in Section 3
of ERISA.
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INFORMATION AS TO COMPANY.
FINANCIAL AND BUSINESS INFORMATION.
The Company shall deliver to each holder of Notes that is an Institutional
Investor:
(a) QUARTERLY STATEMENTS -- within 60 days after the end of each
quarterly fiscal period in each fiscal year of the Company (other than the
last quarterly fiscal period of each such fiscal year), duplicate copies of,
(i) a consolidated balance sheet of the Company and its
Subsidiaries as at the end of such quarter, and
(ii) consolidated statements of operations and cash flows of
the Company and its Subsidiaries, for such quarter and (in the case of
the second and third quarters) for the portion of the fiscal year
ending with such quarter,setting forth in each case in comparative form
the figures for the corresponding periods in the previous fiscal year,
all in reasonable detail, prepared in accordance with GAAP applicable
to quarterly financial statements generally, and certified by a Senior
Financial Officer as fairly presenting, in all material respects, the
financial position of the companies being reported on and their results
of operations and cash flows, subject to changes resulting from
year-end adjustments, PROVIDED that delivery within the time period
specified above of copies of the Company's Quarterly Report on Form
10-Q prepared in compliance with the requirements therefor and filed
with the Securities and Exchange Commission shall be deemed to satisfy
the requirements of this Section 7.1(a);
(b) ANNUAL STATEMENTS -- within 105 days after the end of each fiscal
year of the Company, duplicate copies of,
(i) a consolidated balance sheet of the Company and its
Subsidiaries, as at the end of such year, and
(ii) consolidated statements of operations, stockholders'
equity and cash flows of the Company and its Subsidiaries, for such
year, setting forth in each case in comparative form the figures for
the previous fiscal year, all in reasonable detail, prepared in
accordance with GAAP, and accompanied
(A) by an opinion thereon of independent certified public
accountants of recognized national standing, which opinion shall
state that such financial statements present fairly, in all
material respects, the financial position of the companies being
reported upon and their results of operations and cash flows and
have been prepared in conformity with GAAP, and that the
examination of such accountants in connection with such financial
statements has been made in accordance with
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generally accepted auditing standards, and that such audit
provides a reasonable basis for such opinion in the circumstances,
and
(B) a certificate of such accountants stating that they have
reviewed this Agreement and the other Financing Documents and
stating further whether, in making their audit, they have become
aware of any condition or event that then constitutes a Default or
an Event of Default, and, if they are aware that any such
condition or event then exists, specifying the nature and period
of the existence thereof (it being understood that such
accountants shall not be liable, directly or indirectly, for any
failure to obtain knowledge of any Default or Event of Default
unless such accountants should have obtained knowledge thereof in
making an audit in accordance with generally accepted auditing
standards or did not make such an audit), PROVIDED that the
delivery within the time period specified above of the Company's
Annual Report on Form 10-K for such fiscal year (together with the
Company's annual report to shareholders, if any, prepared pursuant
to Rule 14a-3 under the Exchange Act) prepared in accordance with
the requirements therefor and filed with the Securities and
Exchange Commission, together with the accountant's certificate
described in clause (B) above, shall be deemed to satisfy the
requirements of this Section 7.1(b);
(c) SEC AND OTHER REPORTS -- promptly upon their becoming available,
one copy of (I) each financial statement, report, notice or proxy statement
sent by the Company or any Subsidiary to public securities holders
generally, and (II) each regular or periodic report, each registration
statement (without exhibits except as expressly requested by such holder),
and each prospectus and all amendments thereto filed by the Company or any
Subsidiary with the Securities and Exchange Commission and of all press
releases and other statements made available generally by the Company or any
Subsidiary to the public concerning developments that are Material;
(d) NOTICE OF DEFAULT OR EVENT OF DEFAULT -- promptly, and in any
event within five days after a Responsible Officer becoming aware of the
existence of any Default or Event of Default or that any Person has given
any notice or taken any action with respect to a claimed default hereunder
or that any Person has given any notice or taken any action with respect to
a claimed default of the type referred to in Section 11(f), a written notice
specifying the nature and period of existence thereof and what action the
Company is taking or proposes to take with respect thereto;
(e) ERISA MATTERS -- promptly, and in any event within five days after
a Responsible Officer becoming aware of any of the following, a written
notice setting forth the nature thereof and the action, if any, that the
Company or an ERISA Affiliate proposes to take with respect thereto:
(i) with respect to any Plan, any reportable event, as
defined in section 4043(b) of ERISA and the regulations thereunder, for
which notice thereof has not been waived pursuant to such regulations
as in effect on the date hereof; or
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(ii) the taking by the PBGC of steps to institute, or
the threatening by the PBGC of the institution of, proceedings under
section 4042 of ERISA for the termination of, or the appointment of a
trustee to administer, any Plan, or the receipt by the Company or any
ERISA Affiliate of a notice from a Multiemployer Plan that such action
has been taken by the PBGC with respect to such Multiemployer Plan; or
(iii) any event, transaction or condition that could
result in the incurrence of any liability by the Company or any ERISA
Affiliate pursuant to Title I or IV of ERISA or the penalty or excise
tax provisions of the Code relating to employee benefit plans, or in
the imposition of any Lien on any of the rights, properties or assets
of the Company or any ERISA Affiliate pursuant to Title I or IV of
ERISA or such penalty or excise tax provisions, if such liability or
Lien, taken together with any other such liabilities or Liens then
existing, could reasonably be expected to have a Material Adverse
Effect;
(f) NOTICES FROM GOVERNMENTAL AUTHORITY -- promptly, and in any event
within 30 days of receipt thereof, copies of any notice to the Company or
any Subsidiary from any Federal or state Governmental Authority relating to
any order, ruling, statute or other law or regulation that could reasonably
be expected to have a Material Adverse Effect;
(g) NOTICES PURSUANT TO LICENSE AGREEMENT -- promptly, and in any
event within 5 Business Days of receipt thereof, copies of any report
provided to the Company pursuant to Section 7.1 of the License Agreement;
and
(h) REQUESTED INFORMATION -- with reasonable promptness, such other
data and information relating to the business, operations, affairs,
financial condition, assets or properties of the Company or any of its
Subsidiaries or relating to the ability of the Company to perform its
obligations under the Financing Documents as from time to time may be
reasonably requested by any such holder of Notes.
OFFICER'S CERTIFICATE.
Each set of financial statements delivered to a holder of Notes pursuant to
Section 7.1(a) or Section 7.1(b) hereof shall be accompanied by a certificate of
a Senior Financial Officer setting forth:
(a) COVENANT COMPLIANCE -- the information (including detailed
calculations) required in order to establish whether the Company was in
compliance with the requirements of Section 10.5 and Section 10.6 hereof,
inclusive, during the quarterly or annual period covered by the statements
then being furnished (including with respect to each such Section, where
applicable, the calculations of the maximum or minimum amount, ratio or
percentage, as the case may be, permissible under the terms of such
Sections, and the calculation of the amount, ratio or percentage then in
existence); and
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(b) EVENT OF DEFAULT -- a statement that such officer has reviewed the
relevant terms hereof and has made, or caused to be made, under his or her
supervision, a review of the transactions and conditions of the Company and
its Subsidiaries from the beginning of the quarterly or annual period
covered by the statements then being furnished to the date of the
certificate and that such review shall not have disclosed the existence
during such period of any condition or event that constitutes a Default or
an Event of Default or, if any such condition or event existed or exists
(including, without limitation, any such event or condition resulting from
the failure of the Company or any Subsidiary to comply with any
Environmental Law), specifying the nature and period of existence thereof
and what action the Company shall have taken or proposes to take with
respect thereto.
INSPECTION.
The Company shall permit the representatives of each holder of Notes that is an
Institutional Investor:
(a) NO DEFAULT -- if no Event of Default then exists, at the expense
of such holder and upon reasonable prior notice to the Company, to visit the
principal executive office of the Company, to discuss the affairs, finances
and accounts of the Company and its Subsidiaries with the Company's
officers, and (with the consent of the Company, which consent will not be
unreasonably withheld) its independent public accountants, and (with the
consent of the Company, which consent will not be unreasonably withheld) to
visit the other offices and properties of the Company and each Subsidiary,
all at such reasonable times and as often as may be reasonably requested in
writing; and
(b) DEFAULT -- if an Event of Default then exists, at the expense of
the Company, to visit and inspect any of the offices or properties of the
Company or any Subsidiary, to examine all their respective books of account,
records, reports and other papers, to make copies and extracts therefrom,
and to discuss their respective affairs, finances and accounts with their
respective officers and independent public accountants (and by this
provision the Company authorizes said accountants to discuss the affairs,
finances and accounts of the Company and its Subsidiaries), all at such
times and as often as may be requested.
PAYMENT OF THE NOTES.
REQUIRED PAYMENTS.
On each Note Payment Date on and after December 10, 2000, the Company will make
or cause to be made an installment payment in respect of the Notes, consisting
of a payment of interest and a payment or prepayment of principal in an
aggregate amount for all such payments sufficient to pay 100% of the original
principal amount of the Notes, together with accrued interest thereon, by March
10, 2006 (each such installment payment of principal and interest to be in the
aggregate amount of $1,721,313, subject to adjustment as provided below). Each
such payment on the Notes, when paid, shall be applied first to the payment of
accrued interest and the balance to payment on account of the principal thereof.
Schedule 8.1 sets forth the amortization of the Notes. Upon any
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prepayment of the Notes requiring a reduction in subsequent installment payments
as provided in Section 8.3, the Company shall promptly revise Schedule 8.1 to
incorporate any changes to such amortization as a result of such prepayment and
promptly furnish such revised Schedule to the Collateral Agent and each holder
of a Note.
OPTIONAL PREPAYMENTS WITH MAKE-WHOLE AMOUNT.
The Company may, at its option, upon notice as provided below, prepay at any
time all, or from time to time any part of, the Notes, in an amount not less
than 5% of the aggregate principal amount of the Notes then outstanding in the
case of a partial prepayment, at 100% of the principal amount so prepaid, plus
the Make-Whole Amount determined for the prepayment date with respect to such
principal amount. The Company will give each holder of Notes written notice of
each optional prepayment under this Section 8.2 not less than 30 days and not
more than 60 days prior to the date fixed for such prepayment. Each such notice
shall specify such date, the aggregate principal amount of the Notes to be
prepaid on such date, the principal amount of each Note held by such holder to
be prepaid (determined in accordance with Section 8.3), and the interest to be
paid on the prepayment date with respect to such principal amount being prepaid,
and shall be accompanied by a certificate of a Senior Financial Officer as to
the estimated Make-Whole Amount due in connection with such prepayment
(calculated as if the date of such notice were the date of the prepayment),
setting forth the details of such computation. Two Business Days prior to such
prepayment, the Company shall deliver to each holder of Notes a certificate of a
Senior Financial Officer specifying the calculation of such Make-Whole Amount as
of the specified prepayment date.
ALLOCATION OF PARTIAL PREPAYMENTS.
In the case of each partial prepayment of the Notes pursuant to this Section 8
(i) the principal amount of the Notes to be prepaid shall be allocated among all
of the Notes at the time outstanding in proportion, as nearly as practicable, to
the respective unpaid principal amounts thereof not theretofore called for
prepayment and (ii) the installment payments thereafter payable thereon shall be
reduced to an amount which will fully amortize the remaining aggregate principal
balance thereof with interest at the rate provided for therein on a level
payment basis (as to the aggregate amount of principal and interest paid on each
Note Payment Date) through March 10, 2006.
MATURITY; SURRENDER, ETC.
In the case of each prepayment of Notes pursuant to this Section 8, the
principal amount of each Note to be prepaid shall mature and become due and
payable on the date fixed for such prepayment, together with interest on such
principal amount accrued to such date and the applicable Make-Whole Amount, if
any. From and after such date, unless the Company shall fail to pay such
principal amount when so due and payable, together with the interest and
Make-Whole Amount, if any, as aforesaid, interest on such principal amount shall
cease to accrue. Any Note paid or prepaid in full shall be surrendered to the
Company and cancelled and shall not be reissued, and no Note shall be issued in
lieu of any prepaid principal amount of any Note.
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PURCHASE OF NOTES.
The Company will not and will not permit any Affiliate to purchase, redeem,
prepay or otherwise acquire, directly or indirectly, any of the outstanding
Notes except upon the payment or prepayment of the Notes in accordance with the
terms of this Agreement and the Notes. The Company will promptly cancel all
Notes acquired by it or any Affiliate pursuant to any payment, prepayment or
purchase of Notes pursuant to any provision of this Agreement and no Notes may
be issued in substitution or exchange for any such Notes.
MAKE-WHOLE AMOUNT.
The term "MAKE-WHOLE AMOUNT" means, with respect to any Note, an amount equal to
the excess, if any, of the Discounted Value of the Remaining Scheduled Payments
with respect to the Called Principal of such Note over the amount of such Called
Principal, PROVIDED that the Make-Whole Amount may in no event be less than
zero. For the purposes of determining the Make-Whole Amount, the following terms
have the following meanings:
"CALLED PRINCIPAL" means, with respect to any Note, the principal of
such Note that is to be prepaid pursuant to Section 8.2 or has become
or is declared to be immediately due and payable pursuant to Section
12.1, as the context requires.
"DISCOUNTED VALUE" means, with respect to the Called Principal of any
Note, the amount obtained by discounting all Remaining Scheduled
Payments with respect to such Called Principal from their respective
scheduled due dates to the Settlement Date with respect to such Called
Principal, in accordance with accepted financial practice and at a
discount factor (applied on the same periodic basis as that on which
interest on the Notes is payable) equal to the Reinvestment Yield with
respect to such Called Principal.
"REINVESTMENT YIELD" means, with respect to the Called Principal of any
Note, 0.75% over the yield to maturity implied by (I) the yields
reported, as of 10:00 A.M. (New York City time) on the second Business
Day preceding the Settlement Date with respect to such Called
Principal, on the display designated as Bloomberg Financial Markets
page "PX1" (or such other display as may replace as Bloomberg Financial
Markets page "PX1") for actively traded U.S. Treasury securities having
a maturity equal to the Remaining Average Life of such Called Principal
as of such Settlement Date, or (II) if such yields are not reported as
of such time or the yields reported as of such time are not
ascertainable, the Treasury Constant Maturity Series Yields reported,
for the latest day for which such yields have been so reported as of
the second Business Day preceding the Settlement Date with respect to
such Called Principal, in Federal Reserve Statistical Release H.15
(519) (or any comparable successor publication) for actively traded
U.S. Treasury securities having a constant maturity equal to the
Remaining Average Life of such Called Principal as of such Settlement
Date. Such implied yield will be determined, if necessary, by (A)
converting U.S. Treasury bill quotations to bond-equivalent yields in
accordance with accepted financial practice and (B) interpolating
linearly between (1) the actively traded U.S. Treasury security with
the duration closest to and greater than the Remaining Average Life and
(2) the actively traded
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U.S. Treasury security with the duration closest to and less than the
Remaining Average Life.
"REMAINING AVERAGE LIFE" means, with respect to any Called Principal,
the number of years (calculated to the nearest one-twelfth year)
obtained by dividing (I) such Called Principal into (II) the sum of the
products obtained by multiplying (A) the principal component of each
Remaining Scheduled Payment with respect to such Called Principal by
(B) the number of years (calculated to the nearest one-twelfth year)
that will elapse between the Settlement Date with respect to such
Called Principal and the scheduled due date of such Remaining Scheduled
Payment.
"REMAINING SCHEDULED PAYMENTS" means, with respect to the Called
Principal of any Note, all payments of such Called Principal and
interest thereon that would be due after the Settlement Date with
respect to such Called Principal if no payment of such Called Principal
were made prior to its scheduled due date, PROVIDED that if such
Settlement Date is not a date on which interest payments are due to be
made under the terms of the Notes, then the amount of the next
succeeding scheduled interest payment will be reduced by the amount of
interest accrued to such Settlement Date and required to be paid on
such Settlement Date pursuant to Section 8.2 or 12.1.
"SETTLEMENT DATE" means, with respect to the Called Principal of any
Note, the date on which such Called Principal is to be prepaid pursuant
to Section 8.2 or has become or is declared to be immediately due and
payable pursuant to Section 12.1, as the context requires.
AFFIRMATIVE COVENANTS.
The Company covenants that so long as any of the Notes are outstanding:
COMPLIANCE WITH LAW.
The Company will and will cause each of its Subsidiaries to comply with all
laws, ordinances or governmental rules or regulations to which each of them is
subject, including, without limitation, Environmental Laws, and will obtain and
maintain in effect all licenses, certificates, permits, franchises and other
governmental authorizations necessary to the ownership of their respective
properties or to the conduct of their respective businesses, in each case to the
extent necessary to ensure that non-compliance with such laws, ordinances or
governmental rules or regulations or failures to obtain or maintain in effect
such licenses, certificates, permits, franchises and other governmental
authorizations could not, individually or in the aggregate, reasonably be
expected to have a Material Adverse Effect.
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INSURANCE.
The Company will and will cause each of its Subsidiaries to maintain, with
financially sound and reputable insurers, insurance with respect to their
respective properties and businesses against such casualties and contingencies,
of such types, on such terms and in such amounts (including deductibles,
co-insurance and self-insurance, if adequate reserves are maintained with
respect thereto) as is customary in the case of entities of established
reputations engaged in the same or a similar business and similarly situated.
MAINTENANCE OF PROPERTIES.
The Company will and will cause each of its Subsidiaries to maintain and keep,
or cause to be maintained and kept, their respective properties in good repair,
working order and condition (other than ordinary wear and tear), so that the
business carried on in connection therewith may be properly conducted at all
times, PROVIDED that this Section shall not prevent the Company or any
Subsidiary from discontinuing the operation and the maintenance of any of its
properties if such discontinuance is desirable in the conduct of its business
and the Company has concluded that such discontinuance could not, individually
or in the aggregate, reasonably be expected to have a Material Adverse Effect.
PAYMENT OF TAXES AND CLAIMS.
The Company will and will cause each of its Subsidiaries to file all tax returns
required to be filed in any jurisdiction and to pay and discharge all taxes
shown to be due and payable on such returns and all other taxes, assessments,
governmental charges, or levies imposed on them or any of their properties,
assets, income or franchises, to the extent such taxes and assessments have
become due and payable and before they have become delinquent, and all claims
for which sums have become due and payable that have or might become a Lien on
properties or assets of the Company or any Subsidiary, PROVIDED that neither the
Company nor any Subsidiary need pay any such tax or assessment or claims if (I)
the amount, applicability or validity thereof is contested by the Company or
such Subsidiary on a timely basis in good faith and in appropriate proceedings,
and the Company or a Subsidiary has established adequate reserves therefor in
accordance with GAAP on the books of the Company or such Subsidiary or (II) the
nonpayment of all such taxes, assessments and claims in the aggregate could not
reasonably be expected to have a Material Adverse Effect.
CORPORATE EXISTENCE, ETC.
The Company will at all times preserve and keep in full force and effect its
corporate existence. Subject to Section 10.2, the Company will at all times
preserve and keep in full force and effect the corporate existence of each of
its Subsidiaries (unless merged into the Company or a Subsidiary) and all rights
and franchises of the Company and its Subsidiaries unless, in the good faith
judgment of the Company, the termination of or failure to preserve and keep in
full force and effect such corporate existence, right or franchise could not,
individually or in the aggregate, have a Material Adverse Effect.
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FURTHER ASSURANCES.
The Company shall take, or cause to be taken, all action required or desirable
to maintain good and valid title to the Collateral and shall maintain and
preserve the Liens created by the Security Agreement and the priority thereof.
LICENSE AGREEMENT.
The Company shall (i) perform and observe in all material respects all of its
covenants and obligations contained in the License Agreement, (ii) take all
reasonable and necessary action to prevent the termination or cancellation of
the License Agreement in accordance with the terms thereof or otherwise (and in
connection with the BMG Litigation (as defined in the Security Agreement) shall
not take any action which could reasonably be expected to result in the
termination or cancellation of the License Agreement by BMG) and (iii) promptly
enforce against BMG each material covenant or obligation of the License
Agreement in accordance with its terms.
NEGATIVE COVENANTS.
The Company covenants that so long as any of the Notes are outstanding:
TRANSACTIONS WITH AFFILIATES.
The Company will not and will not permit any Subsidiary to enter into directly
or indirectly any transaction or Material group of related transactions
(including without limitation the purchase, lease, sale or exchange of
properties of any kind or the rendering of any service) with any Affiliate
(other than the Company or another Subsidiary), except in the ordinary course
and pursuant to the reasonable requirements of the Company's or such
Subsidiary's business and upon fair and reasonable terms no less favorable to
the Company or such Subsidiary than would be obtainable in a comparable
arm's-length transaction with a Person not an Affiliate.
MERGER, CONSOLIDATION, ETC.
The Company shall not consolidate with or merge with any other corporation or
convey, transfer or lease substantially all of its assets in a single
transaction or series of transactions to any Person unless:
(a) the successor formed by such consolidation or the survivor of such
merger or the Person that acquires by conveyance, transfer or lease
substantially all of the assets of the Company as an entirety, as the case
may be, shall be a solvent corporation organized and existing under the laws
of the United States or any State thereof (including the District of
Columbia), and, if the Company is not such corporation, (I) such corporation
shall have executed and delivered to each holder of any Notes its assumption
of the due and punctual performance and observance of each covenant and
condition of this Agreement, the Notes and the other Financing Documents and
(II) the Company shall have caused to be delivered to each holder of any
Notes an opinion of nationally recognized independent counsel, or other
independent counsel reasonably satisfactory to the Required Holders, to the
effect that
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all agreements or instruments effecting such assumption are enforceable in
accordance with their terms and comply with the terms hereof; and
(b) immediately after giving effect to such transaction, no Default or
Event of Default shall have occurred and be continuing.
No such conveyance, transfer or lease of substantially all of the assets of the
Company shall have the effect of releasing the Company or any successor
corporation that shall theretofore have become such in the manner prescribed in
this Section 10.2 from its liability under this Agreement, the Notes or the
other Financing Documents.
LIENS.
The Company will not, and will not permit any of its Subsidiaries to, create,
assume, incur or suffer to exist any Lien upon or with respect to any patents,
patent applications or patent rights relating to or supporting the Royalty
Payments now owned or hereafter acquired by the Company or any such Subsidiary,
unless the Notes are contemporaneously secured equally and ratably with any and
all other obligations and Indebtedness secured by such Lien pursuant to
documentation reasonably satisfactory to the Required Holders and provided that,
if requested by the Required Holders, the holders of the Notes shall have been
provided with an opinion of counsel reasonably satisfactory to the Required
Holders to the effect that such documentation is enforceable in accordance with
its terms and complies with the requirements of this Section 10.3.
AMENDMENTS TO LICENSE AGREEMENT.
(a) The Company will not enter into any amendment, modification or
supplement to, or grant any waiver under the License Agreement, without the
prior written consent of the Required Holders.
(b) The Company will not terminate, or consent to any termination of,
the License Agreement, without the prior written consent of all of the
holders of the Notes.
ROYALTY PAYMENT COVERAGE RATIO.
(a) The Company will not permit the Royalty Payment Coverage Ratio to
be less than 1.25 to 1.00 as of the end of any four consecutive fiscal
quarters of the Company.
(b) The Company will not permit the Royalty Payment Coverage Ratio to
be less than 1.00 to 1.00 as of the end of any fiscal quarter of the
Company.
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INCURRENCE OF SECURED INDEBTEDNESS.
The Company will not, and will not permit any Subsidiary to, directly or
indirectly, create, incur, assume, guarantee, or otherwise become directly or
indirectly liable with respect to, any Secured Indebtedness, unless on the date
the Company or such Subsidiary becomes liable with respect to any such Secured
Indebtedness and immediately after giving effect thereto and the concurrent
retirement of any other Secured Indebtedness,
(i) no Default or Event of Default exists;
(ii) the Pro Forma Royalty Payment Coverage Ratio is not less
than 1.50 to 1.00;
(iii) the Secured Indebtedness Ratio is not greater than 2.50
to 1.00; and
(iv) the Lien pursuant to which such Secured Indebtedness
shall be secured shall be created pursuant to the Security Agreement
(as contemplated by Section 10 thereof).
For purposes of this Section 10.6, any Person extending, renewing or refunding
any Secured Indebtedness shall be deemed to have incurred such Indebtedness at
the time of such extension, renewal or refunding.
EVENTS OF DEFAULT.
An "EVENT OF DEFAULT" shall exist if any of the following conditions or events
shall occur and be continuing:
(a) the Company defaults in the payment of any principal or Make-Whole
Amount, if any, on any Note when the same becomes due and payable, whether
at maturity or at a date fixed for prepayment or by declaration or
otherwise; or
(b) the Company defaults in the payment of any interest on any Note or
any other amount due under any other Financing Document for more than five
Business Days after the same becomes due and payable; or
(c) the Company defaults in the performance of or compliance with any
term contained in (i) Section 10.5 hereof or Section 4.1, 4.3, 8.2, 8.4(b)
or 8.6 of the Security Agreement or (ii) Section 7.1(d) or Section 10.2,
10.3, 10.4 or 10.6 and any such default referred to in this clause (ii) is
not remedied within five Business Days after the earlier of (X) a
Responsible Officer obtaining actual knowledge of such default and (Y) the
Company receiving written notice of such default from any holder of a Note
(any such written notice to be identified as a "notice of default" and to
refer specifically to this paragraph (c) of Section 11); or
(d) the Company defaults in the performance of or compliance with any
term contained herein or in any other Financing Document (other than those
referred to in paragraphs (a), (b) and (c) of this Section 11) and such
default is not remedied within 30 days after
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the earlier of (I) a Responsible Officer obtaining actual knowledge of such
default and (II) the Company receiving written notice of such default from
any holder of a Note (any such written notice to be identified as a "notice
of default" and to refer specifically to this paragraph (d) of Section 11);
or
(e) any representation or warranty made in writing by or on behalf of
the Company or by any officer of the Company in this Agreement or in any
other Financing Document or in any writing furnished in connection with the
transactions contemplated hereby proves to have been false or incorrect in
any material respect on the date as of which made; or
(f) (I) the Company or any Subsidiary is in default (as principal or
as guarantor or other surety) in the payment of any principal of or premium
or make-whole amount or interest on any Indebtedness that is outstanding in
an aggregate principal amount of at least $1,000,000 beyond any period of
grace provided with respect thereto, or (II) the Company or any Subsidiary
is in default in the performance of or compliance with any term of any
evidence of any Indebtedness in an aggregate outstanding principal amount of
at least $1,000,000 or of any mortgage, indenture or other agreement
relating thereto or any other condition exists, and as a consequence of such
default or condition such Indebtedness has become, or has been declared, due
and payable before its stated maturity or before its regularly scheduled
dates of payment, or (III) as a consequence of the occurrence or
continuation of any event or condition (other than the passage of time or
the right of the holder of Indebtedness to convert such Indebtedness into
equity interests), the Company or any Subsidiary has become obligated to
purchase or repay Indebtedness before its regular maturity or before its
regularly scheduled dates of payment in an aggregate outstanding principal
amount of at least $1,000,000; or
(g) the Company or any Subsidiary (I) is generally not paying, or
admits in writing its inability to pay, its debts as they become due, (II)
files, or consents by answer or otherwise to the filing against it of, a
petition for relief or reorganization or arrangement or any other petition
in bankruptcy, for liquidation or to take advantage of any bankruptcy,
insolvency, reorganization, moratorium or other similar law of any
jurisdiction, (III) makes an assignment for the benefit of its creditors,
(iv) consents to the appointment of a custodian, receiver, trustee or other
officer with similar powers with respect to it or with respect to any
substantial part of its property, (V) is adjudicated as insolvent or to be
liquidated, or (VI) takes corporate action for the purpose of any of the
foregoing; or
(h) a court or governmental authority of competent jurisdiction enters
an order appointing, without consent by the Company or any of its
Subsidiaries, a custodian, receiver, trustee or other officer with similar
powers with respect to it or with respect to any substantial part of its
property, or constituting an order for relief or approving a petition for
relief or reorganization or any other petition in bankruptcy or for
liquidation or to take advantage of any bankruptcy or insolvency law of any
jurisdiction, or ordering the dissolution, winding-up or liquidation of the
Company or any of its Subsidiaries, or any such petition shall be filed
against the Company or any of its Subsidiaries and such petition shall not
be dismissed within 60 days; or
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(i) a final judgment or judgments for the payment of money aggregating
in excess of $5,000,000 are rendered against one or more of the Company and
its Subsidiaries and which judgments are not, within 60 days after entry
thereof, bonded, discharged or stayed pending appeal, or are not discharged
within 60 days after the expiration of such stay; or
(j) if (I) any Plan shall fail to satisfy the minimum funding
standards of ERISA or the Code for any plan year or part thereof or a waiver
of such standards or extension of any amortization period is sought or
granted under section 412 of the Code, (II) a notice of intent to terminate
any Plan shall have been or is reasonably expected to be filed with the PBGC
or the PBGC shall have instituted proceedings under ERISA section 4042 to
terminate or appoint a trustee to administer any Plan or the PBGC shall have
notified the Company or any ERISA Affiliate that a Plan may become a subject
of any such proceedings, (III) the aggregate "amount of unfunded benefit
liabilities" (within the meaning of section 4001(a)(18) of ERISA) under all
Plans, determined in accordance with Title IV of ERISA, shall exceed
$1,000,000, (IV) the Company or any ERISA Affiliate shall have incurred or
is reasonably expected to incur any liability pursuant to Title I or IV of
ERISA or the penalty or excise tax provisions of the Code relating to
employee benefit plans, (V) the Company or any ERISA Affiliate withdraws
from any Multiemployer Plan, or (VI) the Company or any Subsidiary
establishes or amends any employee welfare benefit plan that provides
post-employment welfare benefits in a manner that would increase the
liability of the Company or any Subsidiary thereunder; and any such event or
events described in clauses (i) through (vi) above, either individually or
together with any other such event or events, could reasonably be expected
to have a Material Adverse Effect; or
(k) the Security Agreement shall cease to be in full force and effect
or to be effective to grant a perfected Lien to the Collateral Agent, for
the benefit of the Secured Parties, on the Collateral described therein with
the priority purported to be created thereby.
As used in Section 11(j), the terms "EMPLOYEE BENEFIT PLAN" and "EMPLOYEE
WELFARE BENEFIT PLAN" shall have the respective meanings assigned to such terms
in Section 3 of ERISA.
REMEDIES ON DEFAULT, ETC.
ACCELERATION.
(a) If an Event of Default with respect to the Company described in
paragraph (g) or (h) of Section 11 (other than an Event of Default described
in clause (i) of paragraph (g) or described in clause (vi) of paragraph (g)
by virtue of the fact that such clause encompasses clause (i) of paragraph
(g)) has occurred, all the Notes then outstanding shall automatically become
immediately due and payable.
(b) If any other Event of Default has occurred and is continuing, any
holder or holders of more than 50% in principal amount of the Notes at the
time outstanding may at any time at its or
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their option, by notice or notices to the Company, declare all the Notes
then outstanding to be immediately due and payable.
(c) If any Event of Default described in paragraph (a) or (b) of
Section 11 has occurred and is continuing, any holder or holders of Notes at
the time outstanding affected by such Event of Default may at any time, at
its or their option, by notice or notices to the Company, declare all the
Notes held by it or them to be immediately due and payable.
Upon any Notes becoming due and payable under this Section 12.1, whether
automatically or by declaration, such Notes will forthwith mature and the entire
unpaid principal amount of such Notes, plus (X) all accrued and unpaid interest
thereon and (Y) the Make-Whole Amount determined in respect of such principal
amount (to the full extent permitted by applicable law), shall all be
immediately due and payable, in each and every case without presentment, demand,
protest or further notice, all of which are hereby waived. The Company
acknowledges, and the parties hereto agree, that each holder of a Note has the
right to maintain its investment in the Notes free from repayment by the Company
(except as herein specifically provided for) and that the provision for payment
of a Make-Whole Amount by the Company in the event that the Notes are prepaid or
are accelerated as a result of an Event of Default, is intended to provide
compensation for the deprivation of such right under such circumstances.
OTHER REMEDIES.
If any Default or Event of Default has occurred and is continuing, and
irrespective of whether any Notes have become or have been declared immediately
due and payable under Section 12.1, the holder of any Note at the time
outstanding may proceed to protect and enforce the rights of such holder by an
action at law, suit in equity or other appropriate proceeding, whether for the
specific performance of any agreement contained herein or in any Note or in any
other Financing Document, or for an injunction against a violation of any of the
terms hereof or thereof, or in aid of the exercise of any power granted hereby
or thereby or by law or otherwise.
RESCISSION.
At any time after any Notes have been declared due and payable pursuant to
paragraph (b) or (c) of Section 12.1, the holders of not less than 66 2/3% in
principal amount of the Notes then outstanding, by written notice to the
Company, may rescind and annul any such declaration and its consequences if (A)
the Company has paid all overdue interest on the Notes, all principal of and
Make-Whole Amount, if any, on any Notes that are due and payable and are unpaid
other than by reason of such declaration, and all interest on such overdue
principal and Make-Whole Amount, if any, and (to the extent permitted by
applicable law) any overdue interest in respect of the Notes, at the Default
Rate, (B) all Events of Default and Defaults, other than non-payment of amounts
that have become due solely by reason of such declaration, have been cured or
have been waived pursuant to Section 17, and (C) no judgment or decree has been
entered for the payment of any monies due pursuant hereto or to the Notes. No
rescission and annulment under this Section 12.3 will extend to or affect any
subsequent Event of Default or Default or impair any right consequent thereon.
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NO WAIVERS OR ELECTION OF REMEDIES, EXPENSES, ETC.
No course of dealing and no delay on the part of any holder of any Note in
exercising any right, power or remedy shall operate as a waiver thereof or
otherwise prejudice such holder's rights, powers or remedies. No right, power or
remedy conferred on any holder of a Note by this Agreement, any Note or any
other Financing Document shall be exclusive of any other right, power or remedy
referred to herein or therein or now or hereafter available at law, in equity,
by statute or otherwise. Without limiting the obligations of the Company under
Section 15, the Company will pay to the holder of each Note on demand such
further amount as shall be sufficient to cover all costs and expenses of such
holder incurred in any enforcement or collection under this Section 12,
including, without limitation, reasonable attorneys' fees, expenses and
disbursements.
REGISTRATION; EXCHANGE; SUBSTITUTION OF NOTES.
REGISTRATION OF NOTES.
The Company shall keep at its principal executive office a register for the
registration and registration of transfers of Notes. The name and address of
each holder of one or more Notes, each transfer thereof and the name and address
of each transferee of one or more Notes shall be registered in such register.
Prior to due presentment for registration of transfer, the Person in whose name
any Note shall be registered shall be deemed and treated as the owner and holder
thereof for all purposes hereof, and the Company shall not be affected by any
notice or knowledge to the contrary. The Company shall give to any holder of a
Note that is an Institutional Investor promptly upon request therefor, a
complete and correct copy of the names and addresses of all registered holders
of Notes.
TRANSFER AND EXCHANGE OF NOTES.
Upon surrender of any Note at the principal executive office of the Company for
registration of transfer or exchange (and in the case of a surrender for
registration of transfer, duly endorsed or accompanied by a written instrument
of transfer duly executed by the registered holder of such Note or his attorney
duly authorized in writing and accompanied by the address for notices of each
transferee of such Note or part thereof), the Company shall execute and deliver,
at the Company's expense (except as provided below), one or more new Notes (as
requested by the holder thereof) in exchange therefor, in an aggregate principal
amount equal to the unpaid principal amount of the surrendered Note. Each such
new Note shall be payable to such Person as such holder may request and shall be
substantially in the form of Exhibit 1. Each such new Note shall be dated and
bear interest from the date to which interest shall have been paid on the
surrendered Note or dated the date of the surrendered Note if no interest shall
have been paid thereon. The Company may require payment of a sum sufficient to
cover any stamp tax or governmental charge imposed in respect of any such
transfer of Notes. Notes shall not be transferred in denominations of less than
$1,000,000, PROVIDED that if necessary to enable the registration of transfer by
a holder of its entire holding of Notes, one Note may be in a denomination of
less than $1,000,000. Any transferee, by its acceptance of a Note registered in
its name (or the name of its nominee), shall be deemed to have made the
representation set forth in Section 6.2.
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REPLACEMENT OF NOTES.
Upon receipt by the Company of evidence reasonably satisfactory to it of the
ownership of and the loss, theft, destruction or mutilation of any Note (which
evidence shall be, in the case of an Institutional Investor, notice from such
Institutional Investor of such ownership and such loss, theft, destruction or
mutilation), and
(a) in the case of loss, theft or destruction, of indemnity reasonably
satisfactory to it (PROVIDED that if the holder of such Note is, or is a
nominee for, an original Purchaser or another holder of a Note with a
minimum net worth of at least $10,000,000, such Person's own unsecured
agreement of indemnity shall be deemed to be satisfactory), or
(b) in the case of mutilation, upon surrender and cancellation
thereof,
the Company at its own expense shall execute and deliver, in lieu thereof, a new
Note, dated and bearing interest from the date to which interest shall have been
paid on such lost, stolen, destroyed or mutilated Note or dated the date of such
lost, stolen, destroyed or mutilated Note if no interest shall have been paid
thereon.
PAYMENTS ON NOTES.
PLACE OF PAYMENT.
Subject to Section 14.2, payments of principal, Make-Whole Amount, if any, and
interest becoming due and payable on the Notes shall be made in New York, New
York at the principal office of Bankers Trust Company in such jurisdiction. The
Company may at any time, by notice to each holder of a Note, change the place of
payment of the Notes so long as such place of payment shall be either the
principal office of the Company in such jurisdiction or the principal office of
a bank or trust company in such jurisdiction.
HOME OFFICE PAYMENT.
So long as you or your nominee shall be the holder of any Note, and
notwithstanding anything contained in Section 14.1 or in such Note to the
contrary, the Company will pay or cause to be paid all sums becoming due on such
Note for principal, Make-Whole Amount, if any, and interest by the method and at
the address specified for such purpose below your name in Schedule A, or by such
other method or at such other address as you shall have from time to time
specified to the Company and the Collateral Agent in writing for such purpose,
without the presentation or surrender of such Note or the making of any notation
thereon, except that upon written request of the Company made concurrently with
or reasonably promptly after payment or prepayment in full of any Note, you
shall surrender such Note for cancellation, reasonably promptly after any such
request, to the Company at its principal executive office or at the place of
payment most recently designated by the Company pursuant to Section 14.1. Prior
to any sale or other disposition of any Note held by you or your nominee you
will, at your election, either endorse thereon the amount of principal paid
thereon and the last date to which interest has been paid thereon or surrender
such Note to the Company in
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exchange for a new Note or Notes pursuant to Section 13.2. The Company will
afford the benefits of this Section 14.2 to any Institutional Investor that is
the direct or indirect transferee of any Note purchased by you under this
Agreement and that has made the same agreement relating to such Note as you have
made in this Section 14.2.
EXPENSES, ETC.
TRANSACTION EXPENSES.
Whether or not the transactions contemplated hereby are consummated, the Company
will pay all costs and expenses (including reasonable attorneys' fees of a
special counsel and, if reasonably required, local or other counsel) incurred by
you, each Other Purchaser, the Collateral Agent or holder of a Note in
connection with such transactions and in connection with the preparation,
negotiation and execution of the Financing Documents and the perfection of the
Liens in the Collateral contemplated by the Security Agreement and in connection
with any amendments, waivers or consents under or in respect of this Agreement,
the other Financing Documents or the Notes (whether or not such amendment,
waiver or consent becomes effective), including, without limitation: (A) the
reasonable costs and expenses incurred in enforcing or defending (or determining
whether or how to enforce or defend) any rights under this Agreement, the Notes
or the other Financing Documents or in responding to any subpoena or other legal
process or informal investigative demand issued in connection with this
Agreement, the Notes or the other Financing Documents, or by reason of being a
holder of any Note, and all reasonable expenses incurred by each holder of a
Note and the Collateral Agent incurred in connection with the preservation of
any Lien or realization on or pursuit of remedies with respect to any Collateral
following the occurrence and during the continuance of any Default or Event of
Default, and (B) the reasonable costs and expenses, including financial
advisors' fees, incurred in connection with the insolvency or bankruptcy of the
Company or any Subsidiary or in connection with any work-out or restructuring of
the transactions contemplated hereby and by the Notes. The Company will pay, and
will save you and each other holder of a Note harmless from, all claims in
respect of any fees, costs or expenses if any, of brokers and finders (other
than those retained by you).
SURVIVAL.
The obligations of the Company under this Section 15 will survive the payment or
transfer of any Note, the enforcement, amendment or waiver of any provision of
this Agreement, the Notes or the other Financing Documents, and the termination
of this Agreement.
SURVIVAL OF REPRESENTATIONS AND WARRANTIES; ENTIRE AGREEMENT.
All representations and warranties contained herein and in the other Financing
Documents shall survive the execution and delivery of this Agreement, the Notes
and the other Financing Documents, the purchase or transfer by you of any Note
or portion thereof or interest therein and the payment of any Note, and may be
relied upon by any subsequent holder of a Note, regardless of any investigation
made at any time by or on behalf of you or any other holder of a Note. All
statements contained in any certificate or other instrument delivered by or on
behalf of the Company pursuant
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to this Agreement or any other Financing Document shall be deemed
representations and warranties of the Company under this Agreement. Subject to
the preceding sentence, this Agreement, the Notes and the other Financing
Documents embody the entire agreement and understanding between you and the
Company and supersede all prior agreements and understandings relating to the
subject matter hereof.
AMENDMENT AND WAIVER.
REQUIREMENTS.
This Agreement and the Notes may be amended, and the observance of any term
hereof or of the Notes may be waived (either retroactively or prospectively),
with (and only with) the written consent of the Company and the Required
Holders, except that (A) no amendment or waiver of any of the provisions of
Section 1, 2, 3, 4, 5, 6 or 21 hereof, or any defined term (as it is used
therein), will be effective as to you unless consented to by you in writing, and
(B) no such amendment or waiver may, without the written consent of the holder
of each Note at the time outstanding affected thereby, (I) subject to the
provisions of Section 12 relating to acceleration or rescission, change the
amount or time of any prepayment or payment of principal of, or reduce the rate
or change the time of payment or method of computation of interest or of the
Make-Whole Amount on, the Notes, (II) change the percentage of the principal
amount of the Notes the holders of which are required to consent to any such
amendment or waiver, or (III) amend any of Sections 8, 9.7, 11(a), 11(b), 12, 17
or 20.
SOLICITATION OF HOLDERS OF NOTES.
(a) SOLICITATION. The Company will provide each holder of the Notes
(irrespective of the amount of Notes then owned by it) with sufficient
information, sufficiently far in advance of the date a decision is required,
to enable such holder to make an informed and considered decision with
respect to any proposed amendment, waiver or consent in respect of any of
the provisions hereof or of the Notes or any other Financing Documents. The
Company will deliver executed or true and correct copies of each amendment,
waiver or consent effected pursuant to the provisions of this Section 17 to
each holder of outstanding Notes promptly following the date on which it is
executed and delivered by, or receives the consent or approval of, the
requisite holders of Notes.
(b) PAYMENT. The Company will not directly or indirectly pay or cause
to be paid any remuneration, whether by way of supplemental or additional
interest, fee or otherwise, or grant any security, to any holder of Notes as
consideration for or as an inducement to the entering into by any holder of
Notes of any waiver or amendment of any of the terms and provisions hereof
or any other Financing Document unless such remuneration is concurrently
paid, or security is concurrently granted, on the same terms, ratably to
each holder of Notes then outstanding even if such holder did not consent to
such waiver or amendment.
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BINDING EFFECT, ETC.
Any amendment or waiver consented to as provided in this Section 17 applies
equally to all holders of Notes and is binding upon them and upon each future
holder of any Note and upon the Company without regard to whether such Note has
been marked to indicate such amendment or waiver. No such amendment or waiver
will extend to or affect any obligation, covenant, agreement, Default or Event
of Default not expressly amended or waived or impair any right consequent
thereon. No course of dealing between the Company and the holder of any Note or
the Collateral Agent nor any delay in exercising any rights hereunder or under
any Note or under any other Financing Document shall operate as a waiver of any
rights of any holder of such Note or the Collateral Agent. As used herein, the
term "THIS AGREEMENT" and references thereto shall mean this Agreement as it may
from time to time be amended or supplemented.
NOTES HELD BY COMPANY, ETC.
Solely for the purpose of determining whether the holders of the requisite
percentage of the aggregate principal amount of Notes then outstanding approved
or consented to any amendment, waiver or consent to be given under this
Agreement or the Notes or any other Financing Document, or have directed the
taking of any action provided herein or in the Notes to be taken upon the
direction of the holders of a specified percentage of the aggregate principal
amount of Notes then outstanding, Notes directly or indirectly owned by the
Company or any of its Affiliates shall be deemed not to be outstanding.
NOTICES.
All notices and communications provided for hereunder shall be in writing and
sent (A) by telecopy if the sender on the same day sends a confirming copy of
such notice by a recognized overnight delivery service (charges prepaid), or (B)
by registered or certified mail with return receipt requested (postage prepaid),
or (C) by a recognized overnight delivery service (with charges prepaid). Any
such notice must be sent:
(i) if to you or your nominee, to you or it at the address
specified for such communications in Schedule A, or at such other
address as you or it shall have specified to the Company in writing,
(ii) if to any other holder of any Note, to such holder at
such address as such other holder shall have specified to the Company
in writing, or
(iii) if to the Collateral Agent, to its address as provided
in the Security Agreement, or
(iv) if to the Company, to the Company at its address set
forth at the beginning hereof to the attention of its Chief Financial
Officer, or at such other address as the Company shall have specified
to the holder of each Note in writing.
Notices under this Section 18 will be deemed given only when actually received.
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REPRODUCTION OF DOCUMENTS.
This Agreement, the other Financing Documents and all documents relating
thereto, including, without limitation, (A) consents, waivers and modifications
that may hereafter be executed, (B) documents received by you and the Collateral
Agent at the Closing (except the Notes themselves), and (C) financial
statements, certificates and other information previously or hereafter furnished
to you and the Collateral Agent, may be reproduced by you by any photographic,
photostatic, microfilm, microcard, miniature photographic or other similar
process and you and the Collateral Agent may destroy any original document so
reproduced. The Company agrees and stipulates that, to the extent permitted by
applicable law, any such reproduction shall be admissible in evidence as the
original itself in any judicial or administrative proceeding (whether or not the
original is in existence and whether or not such reproduction was made by you or
the Collateral Agent in the regular course of business) and any enlargement,
facsimile or further reproduction of such reproduction shall likewise be
admissible in evidence. This Section 19 shall not prohibit the Company or any
other holder of Notes from contesting any such reproduction to the same extent
that it could contest the original, or from introducing evidence to demonstrate
the inaccuracy of any such reproduction.
CONFIDENTIAL INFORMATION.
For the purposes of this Section 20, "CONFIDENTIAL INFORMATION" means
information delivered to you by or on behalf of the Company or any Subsidiary in
connection with the transactions contemplated by or otherwise pursuant to this
Agreement that is proprietary in nature and that was clearly marked or labeled
or otherwise adequately identified when received by you as being confidential
information of the Company or such Subsidiary, PROVIDED that such term does not
include information that (A) was publicly known or otherwise known to you prior
to the time of such disclosure, (B) subsequently becomes publicly known through
no act or omission by you or any person acting on your behalf, (C) otherwise
becomes known to you other than through disclosure by the Company or any
Subsidiary or (D) constitutes financial statements delivered to you under
Section 7.1 that are otherwise publicly available. You will maintain the
confidentiality of such Confidential Information in accordance with procedures
adopted by you in good faith to protect confidential information of third
parties delivered to you, PROVIDED that you may deliver or disclose Confidential
Information to (I) your directors, officers, employees, agents, attorneys and
affiliates (to the extent such disclosure reasonably relates to the
administration of the investment represented by your Notes), (II) your financial
advisors and other professional advisors who agree to hold confidential the
Confidential Information substantially in accordance with the terms of this
Section 20, (iii) any other holder of any Note, (IV) any Institutional Investor
to which you sell or offer to sell such Note or any part thereof or any
participation therein (if such Person has agreed in writing prior to its receipt
of such Confidential Information to be bound by the provisions of this Section
20), (V) any Person from which you offer to purchase any security of the Company
(if such Person has agreed in writing prior to its receipt of such Confidential
Information to be bound by the provisions of this Section 20), (VI) any federal
or state regulatory authority having jurisdiction over you, (VII) the National
Association of Insurance Commissioners or any similar organization, or any
nationally recognized rating agency that requires access to information about
your investment portfolio and which have been informed of the confidential
nature of such information or (VIII) any
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other Person to which such delivery or disclosure may be (W) necessary or
appropriate to effect compliance with any law, rule, regulation or order
applicable to you, (X) necessary or appropriate in response to any subpoena or
other legal process, (Y) necessary or appropriate in connection with any
litigation to which you are a party or (z) reasonably determined by you to be
necessary in the enforcement or for the protection of the rights and remedies
under your Notes and this Agreement, if an Event of Default has occurred and is
continuing. Each holder of a Note, by its acceptance of a Note, will be deemed
to have agreed to be bound by and to be entitled to the benefits of this Section
20 as though it were a party to this Agreement. On reasonable request by the
Company in connection with the delivery to any holder of a Note of information
required to be delivered to such holder under this Agreement or requested by
such holder (other than a holder that is a party to this Agreement or its
nominee), such holder will enter into an agreement with the Company embodying
the provisions of this Section 20.
SUBSTITUTION OF PURCHASER.
You shall have the right to substitute any one of your Affiliates as the
purchaser of the Notes that you have agreed to purchase hereunder, by written
notice to the Company, which notice shall be signed by both you and such
Affiliate, shall contain such Affiliate's agreement to be bound by this
Agreement and shall contain a confirmation by such Affiliate of the accuracy
with respect to it of the representations set forth in Section 6. Upon receipt
of such notice, wherever the word "you" is used in this Agreement (other than in
this Section 21), such word shall be deemed to refer to such Affiliate in lieu
of you. In the event that such Affiliate is so substituted as a purchaser
hereunder and such Affiliate thereafter transfers to you all of the Notes then
held by such Affiliate, upon receipt by the Company of notice of such transfer,
wherever the word "you" is used in this Agreement (other than in this Section
21), such word shall no longer be deemed to refer to such Affiliate, but shall
refer to you, and you shall have all the rights of an original holder of the
Notes under this Agreement.
MISCELLANEOUS.
SUCCESSORS AND ASSIGNS.
All covenants and other agreements contained in this Agreement by or on behalf
of any of the parties hereto bind and inure to the benefit of their respective
successors and assigns (including, without limitation, any subsequent holder of
a Note) whether so expressed or not.
PAYMENTS DUE ON NON-BUSINESS DAYS.
Anything in this Agreement or the Notes or any other Financing Document to the
contrary notwithstanding, any payment of principal of or Make-Whole Amount or
interest on any Note that is due on a date other than a Business Day shall be
made on the next succeeding Business Day without including the additional days
elapsed in the computation of the interest payable on such next succeeding
Business Day.
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SEVERABILITY.
Any provision of this Agreement that is prohibited or unenforceable in any
jurisdiction shall, as to such jurisdiction, be ineffective to the extent of
such prohibition or unenforceability without invalidating the remaining
provisions hereof, and any such prohibition or unenforceability in any
jurisdiction shall (to the full extent permitted by law) not invalidate or
render unenforceable such provision in any other jurisdiction.
CONSTRUCTION.
Each covenant contained herein shall be construed (absent express provision to
the contrary) as being independent of each other covenant contained herein, so
that compliance with any one covenant shall not (absent such an express contrary
provision) be deemed to excuse compliance with any other covenant. Where any
provision herein refers to action to be taken by any Person, or which such
Person is prohibited from taking, such provision shall be applicable whether
such action is taken directly or indirectly by such Person.
COUNTERPARTS.
This Agreement may be executed in any number of counterparts, each of which
shall be an original but all of which together shall constitute one instrument.
Each counterpart may consist of a number of copies hereof, each signed by less
than all, but together signed by all, of the parties hereto.
GOVERNING LAW.
This Agreement shall be construed and enforced in accordance with, and the
rights of the parties shall be governed by, the law of the State of New York
excluding choice-of-law principles of the law of such State that would require
the application of the laws of a jurisdiction other than such State.
* * * * *
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SCHEDULE B
DEFINED TERMS
As used herein, the following terms have the respective meanings set forth below
or set forth in the Section hereof following such term:
"AFFILIATE" means, at any time, and with respect to any Person, (a) any other
Person that at such time directly or indirectly through one or more
intermediaries Controls, or is Controlled by, or is under common Control with,
such first Person, and (b) any Person beneficially owning or holding, directly
or indirectly, 10% or more of any class of voting or equity interests of the
Company or any Subsidiary or any corporation of which the Company and its
Subsidiaries beneficially own or hold, in the aggregate, directly or indirectly,
10% or more of any class of voting or equity interests. As used in this
definition, "CONTROL" means the possession, directly or indirectly, of the power
to direct or cause the direction of the management and policies of a Person,
whether through the ownership of voting securities, by contract or otherwise.
Unless the context otherwise clearly requires, any reference to an "Affiliate"
is a reference to an Affiliate of the Company.
"BMG" means Boehringer Mannheim GmbH, a German company doing business as Roche
Diagnostics.
"BUSINESS DAY" means (A) for the purposes of Section 8.6 only, any day other
than a Saturday, a Sunday or a day on which commercial banks in New York City
are required or authorized to be closed, and (B) for the purposes of any other
provision of this Agreement, any day other than a Saturday, a Sunday or a day on
which commercial banks in New York, New York or Baltimore, Maryland are required
or authorized to be closed.
"CAPITAL LEASE" means, at any time, a lease with respect to which the lessee is
required concurrently to recognize the acquisition of an asset and the
incurrence of a liability in accordance with GAAP.
"CAPITAL LEASE OBLIGATION" means, with respect to any Person and a Capital
Lease, the amount of the obligation of such Person as the lessee under such
Capital Lease which would, in accordance with GAAP, appear as a liability on a
balance sheet of such Person.
"CLOSING" is defined in Section 3.
"CODE" means the Internal Revenue Code of 1986, as amended from time to time,
and the rules and regulations promulgated thereunder from time to time.
"COLLATERAL" is defined in the Security Agreement.
"COLLATERAL AGENT" means Bankers Trust Company, a New York banking corporation.
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"COLLECTION ACCOUNT" is defined in the Security Agreement.
"COMPANY" means IGEN International, Inc., a Delaware corporation.
"CONFIDENTIAL INFORMATION" is defined in Section 20.
"DEBT SERVICE" means, with respect to any period, all payments of interest and
principal in respect of the Notes and any other Secured Indebtedness paid or
payable by the Company during such period.
"DEFAULT" means an event or condition the occurrence or existence of which
would, with the lapse of time or the giving of notice or both, become an Event
of Default.
"DEFAULT RATE" means that rate of interest that is the greater of (I) 10.50% per
annum above the rate of interest stated in clause (a) of the first paragraph of
the Notes or (II) 2% over the rate of interest publicly announced by Bankers
Trust Company in New York, New York as its "base" or "prime" rate.
"ENVIRONMENTAL LAWS" means any and all Federal, state, local, and foreign
statutes, laws, regulations, ordinances, rules, judgments, orders, decrees,
permits, concessions, grants, franchises, licenses, agreements or governmental
restrictions relating to pollution and the protection of the environment or the
release of any materials into the environment, including but not limited to
those related to hazardous substances or wastes, air emissions and discharges to
waste or public systems.
"ERISA" means the Employee Retirement Income Security Act of 1974, as amended
from time to time, and the rules and regulations promulgated thereunder from
time to time in effect.
"ERISA AFFILIATE" means any trade or business (whether or not incorporated) that
is treated as a single employer together with the Company under section 414 of
the Code.
"EVENT OF DEFAULT" is defined in Section 11.
"EXCHANGE ACT" means the Securities Exchange Act of 1934, as amended.
"FINANCING DOCUMENTS" means this Agreement, the Other Agreements, the Security
Agreement and the Notes.
"GAAP" means generally accepted accounting principles as in effect from time to
time in the United States of America.
"GOVERNMENTAL AUTHORITY" means
(a) the government of
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(i) the United States of America or any State or other
political subdivision thereof, or
(ii) any jurisdiction in which the Company or any Subsidiary
conducts all or any part of its business, or which asserts jurisdiction
over any properties of the Company or any Subsidiary, or
(b) any entity exercising executive, legislative, judicial, regulatory
or administrative functions of, or pertaining to, any such
government.
"GUARANTY" means, with respect to any Person, any obligation (except the
endorsement in the ordinary course of business of negotiable instruments for
deposit or collection) of such Person guaranteeing or in effect guaranteeing any
indebtedness, dividend or other obligation of any other Person in any manner,
whether directly or indirectly, including (without limitation) obligations
incurred through an agreement, contingent or otherwise, by such Person:
(a) to purchase such indebtedness or obligation or any property
constituting security therefor;
(b) to advance or supply funds (I) for the purchase or payment of such
indebtedness or obligation, or (II) to maintain any working capital or other
balance sheet condition or any income statement condition of any other
Person or otherwise to advance or make available funds for the purchase or
payment of such indebtedness or obligation;
(c) to lease properties or to purchase properties or services
primarily for the purpose of assuring the owner of such indebtedness or
obligation of the ability of any other Person to make payment of the
indebtedness or obligation; or
(d) otherwise to assure the owner of such indebtedness or obligation
against loss in respect thereof.
In any computation of the indebtedness or other liabilities of the obligor under
any Guaranty, the indebtedness or other obligations that are the subject of such
Guaranty shall be assumed to be direct obligations of such obligor.
"HAZARDOUS MATERIAL" means any and all pollutants, toxic or hazardous wastes or
any other substances that might pose a hazard to health or safety, the removal
of which may be required or the generation, manufacture, refining, production,
processing, treatment, storage, handling, transportation, transfer, use,
disposal, release, discharge, spillage, seepage, or filtration of which is or
shall be restricted, prohibited or penalized by any applicable law (including,
without limitation, asbestos, urea formaldehyde foam insulation and
polychlorinated biphenyls).
"HOLDER" means, with respect to any Note, the Person in whose name such Note is
registered in the register maintained by the Company pursuant to Section 13.1.
"INDEBTEDNESS" with respect to any Person means, at any time, without
duplication,
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(a) its liabilities for borrowed money and its redemption obligations
in respect of mandatorily redeemable Preferred Stock;
(b) its liabilities for the deferred purchase price of property
acquired by such Person (excluding accounts payable arising in the ordinary
course of business but including all liabilities created or arising under
any conditional sale or other title retention agreement with respect to any
such property);
(c) all liabilities appearing on its balance sheet in accordance with
GAAP in respect of Capital Leases;
(d) all liabilities for borrowed money secured by any Lien with
respect to any property owned by such Person (whether or not it has assumed
or otherwise become liable for such liabilities);
(e) all its liabilities in respect of letters of credit or instruments
serving a similar function issued or accepted for its account by banks and
other financial institutions (whether or not representing obligations for
borrowed money);
(f) Swaps of such Person; and
(g) any Guaranty of such Person with respect to liabilities of a type
described in any of clauses (a) through (f) hereof.
Indebtedness of any Person shall include all obligations of such Person of the
character described in clauses (a) through (g) to the extent such Person remains
legally liable in respect thereof notwithstanding that any such obligation is
deemed to be extinguished under GAAP.
"INSTITUTIONAL INVESTOR" means (A) any original purchaser of a Note, (B) any
holder of a Note holding more than 5% of the aggregate principal amount of the
Notes then outstanding, and (C) any bank, trust company, savings and loan
association or other financial institution, any pension plan, any investment
company, any insurance company, any broker or dealer, or any other similar
financial institution or entity, regardless of legal form.
"LICENSE AGREEMENT" means the License and Technology Development Agreement dated
as of September 23, 1992 between the Company and BMG, as in effect from time to
time.
"LIEN" means, with respect to any Person, any mortgage, lien, pledge, charge,
security interest or other encumbrance, or any interest or title of any vendor,
lessor, lender or other secured party to or of such Person under any conditional
sale or other title retention agreement or Capital Lease, upon or with respect
to any property or asset of such Person (including in the case of stock,
stockholder agreements, voting trust agreements and all similar arrangements).
"MAKE-WHOLE AMOUNT" is defined in Section 8.6.
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"MATERIAL" means material in relation to the business, operations, affairs,
financial condition, assets, properties, or prospects of the Company and its
Subsidiaries taken as a whole.
"MATERIAL ADVERSE EFFECT" means a material adverse effect on (A) the business,
operations, affairs, financial condition, assets or properties of the Company
and its Subsidiaries taken as a whole, or (B) the ability of the Company to
perform its obligations under this Agreement, the Notes or any of the other
Financing Documents, or (c) the validity or enforceability of this Agreement,
the Notes or any of the other Financing Documents or any Lien created
thereunder.
"MAXIMUM PRO FORMA DEBT SERVICE" means, on any date (and after giving effect to
any Senior Indebtedness proposed to be incurred on such date), the greatest
amount of Debt Service which the Company would be projected to have to pay
during any period of four consecutive fiscal quarters through the maturity date
of the Notes. For the purpose of the foregoing calculation, if interest payable
on any Secured Indebtedness is not determinable in advance because the interest
rate is not a fixed rate, such interest rate shall be assumed to be the interest
rate in effect on the date of calculation plus 100 basis points.
"MEMORANDUM" is defined in Section 5.3.
"MULTIEMPLOYER PLAN" means any Plan that is a "multiemployer plan" (as such term
is defined in section 4001(a)(3) of ERISA).
"NOTE PAYMENT DATE" means the 10th day of each March, June, September and
December in each year.
"NOTES" is defined in Section 1.
"OFFICER'S CERTIFICATE" means a certificate of a Senior Financial Officer or of
any other officer of the Company whose responsibilities extend to the subject
matter of such certificate.
"OTHER PURCHASERS" is defined in Section 2.
"PBGC" means the Pension Benefit Guaranty Corporation referred to and defined in
ERISA or any successor thereto.
"PERSON" means an individual, partnership, corporation, limited liability
company, association, trust, unincorporated organization, or a government or
agency or political subdivision thereof.
"PLAN" means an "employee benefit plan" (as defined in section 3(3) of ERISA)
that is or, within the preceding five years, has been established or maintained,
or to which contributions are or, within the preceding five years, have been
made or required to be made, by the Company or any ERISA Affiliate or with
respect to which the Company or any ERISA Affiliate may have any liability.
"PREFERRED STOCK" means any class of capital stock of a corporation that is
preferred over any other class of capital stock of such corporation as to the
payment of dividends or the payment of any amount upon liquidation or
dissolution of such corporation.
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"PRO FORMA ROYALTY PAYMENT COVERAGE RATIO" means, at any time, the ratio of (a)
Royalty Payments for the period of four consecutive fiscal quarters of the
Company ending on, or most recently ended prior to, such time to (b) Maximum Pro
Forma Debt Service.
"PROPERTY" or "PROPERTIES" means, unless otherwise specifically limited, real or
personal property of any kind, tangible or intangible, choate or inchoate.
"QPAM EXEMPTION" means Prohibited Transaction Class Exemption 84-14 issued by
the United States Department of Labor.
"REQUIRED HOLDERS" means, at any time, the holders of at least 66 2/3% in
principal amount of the Notes at the time outstanding (exclusive of Notes then
owned by the Company or any of its Affiliates).
"RESPONSIBLE OFFICER" means any Senior Financial Officer and any other officer
of the Company with responsibility for the administration of the relevant
portion of this agreement.
"ROYALTY PAYMENT COVERAGE RATIO" means, as at the last day of any fiscal quarter
of the Company, the ratio of (a) Royalty Payments for the period of four
consecutive fiscal quarters of the Company ending on such day to (b) Debt
Service for such period; provided, however, that for the purpose of calculating
the Royalty Payment Coverage Ratio for each fiscal quarter ending on or before
December 31, 2000 Debt Service shall be deemed to be $6,885,252.
"ROYALTY PAYMENTS" means the net amount of all royalty payments made to the
Company pursuant to the License Agreement.
"SEC REPORTS" is defined in Section 5.3.
"SECURED INDEBTEDNESS" means Indebtedness secured by Royalty Payments (including
the Notes and obligations relating thereto).
"SECURED INDEBTEDNESS RATIO" means, at any time, the ratio of (a) the principal
amount of all Secured Indebtedness outstanding at such time to (b) Royalty
Payments for the period of four consecutive fiscal quarters of the Company
ending on, or most recently ended prior to, such time.
"SECURED PARTIES" is defined in the Security Agreement.
"SECURITIES ACT" means the Securities Act of 1933, as amended from time to time.
"SECURITY AGREEMENT" means the Collateral Account and Security Agreement dated
as of the date hereof, substantially in the form of Exhibit 2.
"SENIOR FINANCIAL OFFICER" means the chief financial officer, principal
accounting officer, treasurer or comptroller of the Company.
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"SUBSIDIARY" means, as to any Person, any corporation, association or other
business entity in which such Person or one or more of its Subsidiaries or such
Person and one or more of its Subsidiaries owns sufficient equity or voting
interests to enable it or them (as a group) ordinarily, in the absence of
contingencies, to elect a majority of the directors (or Persons performing
similar functions) of such entity, and any partnership or joint venture if more
than a 50% interest in the profits or capital thereof is owned by such Person or
one or more of its Subsidiaries or such Person and one or more of its
Subsidiaries (unless such partnership or joint venture can and does ordinarily
take major business actions without the prior approval of such Person or one or
more of its Subsidiaries). Unless the context otherwise clearly requires, any
reference to a "Subsidiary" is a reference to a Subsidiary of the Company.
"SWAPS" means, with respect to any Person, payment obligations with respect to
interest rate swaps, currency swaps and similar obligations obligating such
Person to make payments, whether periodically or upon the happening of a
contingency. For the purposes of this Agreement, the amount of the obligation
under any Swap shall be the amount determined in respect thereof as of the end
of the then most recently ended fiscal quarter of such Person, based on the
assumption that such Swap had terminated at the end of such fiscal quarter, and
in making such determination, if any agreement relating to such Swap provides
for the netting of amounts payable by and to such Person thereunder or if any
such agreement provides for the simultaneous payment of amounts by and to such
Person, then in each such case, the amount of such obligation shall be the net
amount so determined.
"WHOLLY-OWNED SUBSIDIARY" means, at any time, any Subsidiary one hundred percent
(100%) of all of the equity interests (except directors' qualifying shares) and
voting interests of which are owned by any one or more of the Company and the
Company's other Wholly-Owned Subsidiaries at such time.
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EXHIBIT 1
[FORM OF NOTE]
IGEN INTERNATIONAL, INC.
8.50% SENIOR SECURED NOTE DUE 2006
No. [ ] [Date]
------------
$[ ] PPN 449929 A* 9
--------
FOR VALUE RECEIVED, the undersigned, IGEN INTERNATIONAL, INC. (herein called the
"Company"), a corporation organized and existing under the laws of the State of
Delaware, hereby promises to pay to [ ], or registered assigns, the
principal sum of [ ] DOLLARS (or so much thereof as shall not have been
prepaid), on March 10, 2006, with interest (computed on the basis of a 360-day
year of twelve 30-day months) (A) on the unpaid balance thereof at the rate of
8.50% per annum from the date hereof, payable on each Note Payment Date (as
defined in the Note Purchase Agreements referred to below), commencing with the
first such Note Payment Date next succeeding the date hereof, until the
principal hereof shall have become due and payable, and (B) to the extent
permitted by law, on any overdue payment (including any overdue prepayment) of
principal, any overdue payment of interest and any overdue payment of any
Make-Whole Amount (as defined in the Note Purchase Agreements referred to
below), payable on each Note Payment Date (or, at the option of the registered
holder hereof, on demand), at a rate per annum from time to time equal to the
greater of (I) 10.50% or (II) 2% over the rate of interest publicly announced by
Bankers Trust Company from time to time in New York, New York as its "base" or
"prime" rate.
The principal of this Note shall be payable on the each Note Payment Date on or
after December 10, 2000, in equal quarterly installments of principal and
interest (as more fully provided in the Note Purchase Agreements referred to
below) in such amount as shall fully pay the unpaid balance of the principal
amount of this Note, together with accrued interest, on March 10, 2006. Each
installment of combined principal and interest shall be applied first to the
payment of accrued interest and the balance to payment on account of the
principal hereof.
Payments of principal of, interest on and any Make-Whole Amount with respect to
this Note are to be made in lawful money of the United States of America at the
principal office of Bankers Trust Company in New York, New York or at such other
place as the Company shall have designated by written notice to the holder of
this Note as provided in the Note Purchase Agreements referred to below.
This Note is one of a series of Senior Secured Notes (herein called the "Notes")
issued pursuant to separate Note Purchase Agreements, dated as of March 22, 1999
(as from time to time amended, the "Note Purchase Agreements"), between the
Company and the respective Purchasers named therein
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and is entitled to the benefits thereof. Each holder of this Note will be
deemed, by its acceptance hereof, (I) to have agreed to the confidentiality
provisions set forth in Section 20 of the Note Purchase Agreements and (II) to
have made the representation set forth in Section 6.2 of the Note Purchase
Agreements.
This Note is secured by, and entitled to the benefits of, the Security Agreement
referred to in the Note Purchase Agreements.
This Note is a registered Note and, as provided in the Note Purchase Agreements,
upon surrender of this Note for registration of transfer, duly endorsed, or
accompanied by a written instrument of transfer duly executed, by the registered
holder hereof or such holder's attorney duly authorized in writing, a new Note
for a like principal amount will be issued to, and registered in the name of,
the transferee. Prior to due presentment for registration of transfer, the
Company may treat the person in whose name this Note is registered as the owner
hereof for the purpose of receiving payment and for all other purposes, and the
Company will not be affected by any notice to the contrary.
The Company will make required prepayments of principal on the dates and in the
amounts specified in the Note Purchase Agreements. This Note is also subject to
optional prepayment, in whole or from time to time in part, at the times and on
the terms specified in the Note Purchase Agreements, but not otherwise.
If an Event of Default, as defined in the Note Purchase Agreements, occurs and
is continuing, the principal of this Note may be declared or otherwise become
due and payable in the manner, at the price (including any applicable Make-Whole
Amount) and with the effect provided in the Note Purchase Agreements.
This Note shall be construed and enforced in accordance with the laws of the
State of New York.
IGEN INTERNATIONAL, INC.
By
------------------------------------
Title
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- --------------------------------------------------------------------------------
- --------------------------------------------------------------------------------
COLLATERAL ACCOUNT AND SECURITY AGREEMENT
Dated as of March 22, 1999
among
IGEN INTERNATIONAL, INC.
THE PURCHASERS PARTY HERETO
Bankers Trust Company,
as Collateral Agent
and
Bankers Trust Company,
as Depositary Bank
- --------------------------------------------------------------------------------
- --------------------------------------------------------------------------------
1
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TABLE OF CONTENTS
<TABLE>
<CAPTION>
PAGE
<S> <C>
Section 1. Definitions...........................................................................................4
Section 1.1. CAPITALIZED TERMS..........................................................................4
Section 1.2. UNIFORM COMMERCIAL CODE; INTERPRETATION....................................................6
Section 2. COLLATERAL AGENT......................................................................................7
Section 2.1. APPOINTMENT AND DUTIES OF THE COLLATERAL AGENT.............................................7
Section 2.2. RIGHTS OF COLLATERAL AGENT.................................................................7
Section 2.3. INDEMNIFICATION AND FEES OF THE COLLATERAL AGENT...........................................9
Section 2.4. RESIGNATION OR REMOVAL OF THE COLLATERAL AGENT............................................10
Section 2.5. SUCCESSOR COLLATERAL AGENT................................................................11
Section 2.6. CONSENTS UNDER COLLATERAL DOCUMENTS.......................................................11
Section 2.7. DEPOSITARY BANK...........................................................................11
Section 3. THE ACCOUNTS.........................................................................................11
Section 3.1. DEPOSITARY BANK; MAINTENANCE OF ACCOUNTS; LIMITED COMPANY RIGHTS..........................11
Section 3.2. ESTABLISHMENT OF ACCOUNTS.................................................................12
Section 4. DEPOSITS INTO ACCOUNTS...............................................................................13
Section 4.1. DEPOSIT OF ROYALTY PAYMENTS, ETC..........................................................13
Section 4.2. NOTICE OF DEPOSITS TO COLLATERAL AGENT....................................................13
Section 4.3. INITIAL DEPOSIT INTO RESERVE ACCOUNT......................................................13
SECTION 5. DISBURSEMENTS FROM ACCOUNTS..........................................................................13
Section 5.1. DISBURSEMENTS FROM THE COLLECTION ACCOUNT.................................................13
Section 5.2. DISBURSEMENTS FROM THE RESERVE ACCOUNT....................................................14
Section 5.3. TRANSFERS WHEN AN EVENT OF DEFAULT IS CONTINUING..........................................15
Section 5.4. DISPOSITION OF ACCOUNTS UPON PAYMENT OF SECURED OBLIGATIONS...............................15
Section 6. PERMITTED INVESTMENTS................................................................................15
Section 7. COLLATERAL...........................................................................................15
Section 8. FURTHER ASSURANCES; REMEDIES.........................................................................16
Section 8.1. DELIVERY AND OTHER PERFECTION.............................................................16
Section 8.2. OTHER FINANCING STATEMENTS AND LIENS......................................................16
Section 8.3. PRESERVATION OF RIGHTS....................................................................16
Section 8.4. SPECIAL PROVISIONS RELATING TO LICENSE AGREEMENT..........................................16
Section 8.5. EVENTS OF DEFAULT, ETC....................................................................17
Section 8.6. REMOVALS, ETC.............................................................................18
Section 8.7. PRIVATE SALE..............................................................................18
Section 8.8. ATTORNEY-IN-FACT..........................................................................18
Section 8.9. PERFECTION................................................................................19
Section 8.10. TERMINATION OF SECURITY INTEREST.........................................................19
Section 8.11. EXPENSES.................................................................................19
Section 8.12. FURTHER ASSURANCES.......................................................................19
Section 9. APPLICATION OF PROCEEDS..............................................................................19
Section 10. ADDITIONAL SECURED INDEBTEDNESS.....................................................................20
</TABLE>
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<TABLE>
<S> <C>
Section 11. MISCELLANEOUS.......................................................................................21
Section 11.1. NO WAIVER................................................................................21
Section 11.2. SEVERABILITY.............................................................................22
Section 11.3. SUCCESSORS AND ASSIGNS...................................................................22
Section 11.4. COUNTERPARTS.............................................................................22
Section 11.5. AMENDMENT, WAIVER, ETC...................................................................22
Section 11.6. HEADINGS.................................................................................22
Section 11.7. NOTICES..................................................................................22
Section 11.8. REINSTATEMENT............................................................................22
Section 11.9. TERMINATION..............................................................................22
Section 11.10. NO THIRD PARTY BENEFICIARIES............................................................23
Section 11.11. GOVERNING LAW...........................................................................23
</TABLE>
Annex A Form of Withdrawal Request
3
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COLLATERAL ACCOUNT AND SECURITY AGREEMENT
COLLATERAL ACCOUNT AND SECURITY AGREEMENT dated as of March 22, 1999
among IGEN INTERNATIONAL, INC., a corporation duly organized and validly
existing under the laws of the State of Delaware (the "COMPANY"); the
institutions named on the signature pages hereof under the caption "PURCHASERS";
Bankers Trust Company, acting in its capacity as collateral agent for the
Secured Parties (in such capacity, together with its successors and permitted
assigns, the "COLLATERAL AGENT"), and Bankers Trust Company, acting in its
capacity as depositary bank for the Secured Parties (in such capacity, together
with its successors and permitted assigns, the "DEPOSITARY BANK") in each case
as herein provided.
The Company has authorized the issuance of $30,000,000 aggregate
principal amount of its 8.50% Senior Secured Notes due 2006 pursuant to the
separate Note Purchase Agreements (collectively, as amended, restated, modified
or supplemented and in effect from time to time, the "NOTE PURCHASE AGREEMENT"),
each dated as of March 22, 1999, with each of the purchasers named on Schedule A
thereto.
The parties hereto desire to enter into this Agreement to set forth
their mutual understanding with respect to the appointment of the Collateral
Agent and various matters with respect to the Accounts and the Collateral (each
as defined below).
NOW, THEREFORE, to induce the Purchasers to enter into the Note
Purchase Agreement and to purchase the Notes to be purchased by each such
Purchaser, and for and in consideration of the premises and of the covenants
herein contained, and for other good and valuable consideration, the receipt and
adequacy of which are hereby acknowledged, the parties hereto intending to be
legally bound, covenant and agree as follows:
SECTION 1. DEFINITIONS.
SECTION 1.1. CAPITALIZED TERMS. Capitalized terms used herein and not
defined herein shall have the meanings assigned thereto in the Note Purchase
Agreement, whether specifically set forth therein or by reference to another
document. In addition, as used herein the following terms shall have the
following respective meanings (all terms defined in this Section 1.1 and in the
other provisions of this Agreement in the singular to have the same meanings
when used in the plural and VICE VERSA):
"ACCOUNTS" has the meaning set forth in Section 3.2(a).
"BMG LITIGATION" means the litigation between the Company and BMG
described under the heading "BOEHRINGER MANNHEIM ('ROCHE')" in Note 3 to the
Company's financial statements for the fiscal quarter ended December 31,
1998.
"COLLATERAL" has the meaning set forth in Section 7.
"COLLATERAL AGENT" is defined in the preamble hereto.
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"COLLATERAL DOCUMENTS" means this Agreement and all UCC financing
statements required by this Agreement to be filed with respect to the Liens
on personal property of the Company created pursuant hereto.
"COLLECTION ACCOUNT" means the securities account entitled "Collection
Account" maintained by and in the name of the Collateral Agent with its
Corporate Trust Department at the Depositary Bank in New York, New York.
"COMPANY" is defined in the preamble hereto.
"DEPOSITARY BANK" is defined in the preamble hereto.
"FUNDS" means, collectively, all Permitted Investments and all other
items of property (whether investment property, financial asset, security,
instrument or cash) deposited in or credited to either Account.
"NOTEHOLDER" means the holder or holders from time to time of the
Notes.
"NOTE PURCHASE AGREEMENT" is defined in the preamble hereto.
"PERMITTED INVESTMENTS" means:
(a) direct obligations of, or obligations the principal of and interest
on which are unconditionally guaranteed by, the United States of America (or
by any agency thereof to the extent such obligations are backed by the full
faith and credit of the United States of America), in each case maturing
within one year from the date of acquisition thereof;
(b) investments in commercial paper maturing within 270 days from the
date of acquisition thereof and having, at such date of acquisition, the
highest credit rating obtainable from Standard & Poor's Rating Group, a
division of McGraw-Hill, Inc. ("S&P"), or from Moody's Investors Service,
Inc. ("MOODY'S");
(c) investments in certificates of deposit, banker's acceptances and
time deposits maturing within 180 days from the date of acquisition thereof
issued or guaranteed by or placed with, and money market deposit accounts
issued or offered by, any domestic office of any commercial bank organized
under the laws of the United States of America or any State thereof which
(i) has a combined capital and surplus and undivided profits of not less
than $500,000,000 and (ii) whose long-term unsecured debt obligations (or
the long-term unsecured debt obligations of the bank holding company owning
all of the capital stock of such bank) shall have been given one of the
highest three ratings by at least one credit rating agency of recognized
national standing in the United States of America;
(d) fully collateralized repurchase agreements with a term of not more
than 30 days for securities described in clause (a) above and entered into
with a financial institution satisfying the criteria described in clause (c)
above; and
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(e) money market mutual funds (including money market funds or money
market mutual funds for which the Collateral Agent in its individual
capacity or any of its Affiliates is investment manager or advisor or from
which the Collateral Agent in its individual capacity or any of its
Affiliates charges or collects fees and expenses for services rendered)
which are rated by S&P and Moody's at the time at which the investment is
made in one of its three highest long-term rating categories.
"REQUIRED RESERVE BALANCE" means, as of any date (a) prior to the first
Note Payment Date, $600,000, (b) on or after the first Note Payment Date but
prior to the second Note Payment Date, $800,000, (c) on or after the second
Note Payment Date but prior to the third Note Payment Date, $1,000,000, (d)
on or after the third Note Payment Date but prior to the fourth Note Payment
Date, $1,200,000, (e) on or after the fourth Note Payment Date but prior to
the fifth Note Payment Date, $1,400,000, (f) on or after the fifth Note
Payment Date but prior to the sixth Note Payment Date, $1,700,000 and (g) on
or after the sixth Note Payment Date, an amount equal to the aggregate
amount of (1) all payments of principal of, interest on and Make-Whole
Amount, if any, payable with respect to, the Notes and (2) all other amounts
payable to the Collateral Agent or any Secured Party with respect to the
Secured Obligations, in the case of both of the foregoing clauses (1) and
(2), which are due and owing on the next succeeding Note Payment Date.
"RESERVE ACCOUNT" means the securities account entitled "Reserve
Account" maintained by and in the name of the Collateral Agent with its
Corporate Trust Department at the Depositary Bank in New York, New York.
"RESERVE ACCOUNT BALANCE" means on any date an amount equal to the
collected credit balance of Funds held in or credited to the Reserve Account
on such date.
"SECURED OBLIGATIONS" means (a) the principal of, interest on and
Make-Whole Amount, if any, payable with respect to, the Notes and (b) all
other amounts from time to time payable to the Collateral Agent or any
Noteholder under the Note Purchase Agreement or any other Financing
Document.
"SECURED PARTIES" means, collectively, the Noteholders and the
Collateral Agent and their respective successors and assigns.
"UCC" means the Uniform Commercial Code of the State of New York.
"WITHDRAWAL REQUEST" means a request substantially in the form of Annex
A hereto.
SECTION 1.2. UNIFORM COMMERCIAL CODE; INTERPRETATION. All terms defined
in the UCC shall have the respective meanings given to those terms in the UCC,
except where the context otherwise requires. Unless the context otherwise
requires, any reference in this Agreement to any agreement shall mean such
agreement and all schedules, exhibits and attachments thereto as
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<PAGE>
amended, supplemented, modified or replaced. Unless otherwise stated, any
reference in this Agreement to any Person shall include its permitted successors
and assigns.
SECTION 2. COLLATERAL AGENT.
SECTION 2.1. APPOINTMENT AND DUTIES OF THE COLLATERAL AGENT.
(a) Each Noteholder on the date hereof, and each other Secured Party
from time to time by its acceptance of the security interests granted under
the Collateral Documents, hereby designates and appoints Bankers Trust
Company to act on its behalf as the Collateral Agent under the Collateral
Documents, and hereby authorizes the Collateral Agent to execute, deliver
and perform, on behalf of each of the Secured Parties, each Collateral
Document to which the Collateral Agent is or is intended to be a party and
to take such actions on behalf of the Secured Parties under the provisions
of such Collateral Documents and to exercise such powers and perform such
duties as are expressly delegated to the Collateral Agent by the terms of
each Collateral Document, together with such other powers as are reasonably
incidental thereto. Notwithstanding any provision to the contrary elsewhere
in any Collateral Document, the Collateral Agent shall not have any duties
or responsibilities, except those expressly set forth herein and in the
Collateral Documents, or any fiduciary relationship with any Secured Party,
and no implied covenants, functions or responsibilities shall be read into
any Collateral Document or otherwise exist against the Collateral Agent.
(b) The Collateral Agent will forward to each Secured Party at its last
address on the records of the Collateral Agent promptly after the Collateral
Agent's receipt thereof (and will use its reasonable efforts to forward
within two Business Days of the receipt) a copy of each document furnished
to the Collateral Agent under any Financing Document (including each
Withdrawal Request).
(c) The Collateral Agent shall deliver to the Company and each Secured
Party, within five Business Days after the end of each calendar month
(commencing with the calendar month in which the first deposit is made to
the Collection Account), a report in reasonable detail setting forth with
respect to each Account all deposits to and disbursements from such Account
during such calendar month, including the date on which made, and the
balances of and any investments in such Account as of the end of such
calendar month. The Collateral Agent shall provide any additional
information or reports relating to any such Account and the transactions
therein reasonably requested in writing from time to time by the Company or
any Secured Party.
(d) The Collateral Agent hereby waives any Lien it may now have, or may
subsequently acquire, in or on any Collateral other than the security
interests granted under the Collateral Documents, any right to apply the
Collateral against claims other than claims of the Secured Parties in
respect of the security interests granted under this Agreement and any right
to set off claims against such Collateral other than claims of the Secured
Parties in respect of such security interests.
SECTION 2.2. RIGHTS OF COLLATERAL AGENT.
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(a) The Collateral Agent may execute any of its duties under this
Agreement by or through agents or attorneys-in-fact, provided that the
Collateral Agent shall be liable for any willful misconduct or gross
negligence on the part of any such agents or attorneys-in-fact (other than
any such agents or attorneys-in-fact retained by the Collateral Agent at the
direction of, or with the prior approval of, the Required Holders).
(b) Neither the Collateral Agent nor any of its officers, directors,
employees, agents, attorneys-in-fact or affiliates shall be (i) liable for
any action lawfully taken or omitted to be taken by it under or in
connection with this Agreement (except for its own gross negligence or its
own willful misconduct), (ii) responsible in any manner to any of the
Secured Parties for any recitals, statements, representations or warranties
made by the Company or any other party (other than the Collateral Agent) or
any representative thereof contained in the Financing Documents or in any
certificate, report, statement or other document referred to or provided for
in, or received by the Collateral Agent under or in connection with, any
Financing Document or for the value, validity, effectiveness, genuineness,
enforceability or sufficiency of any Financing Document or for any failure
of the Company or any other party (other than the Collateral Agent) to
perform their respective obligations thereunder, (iii) responsible or liable
in any manner whatever for soliciting any funds or for the sufficiency,
correctness, genuineness or validity of any funds, securities or other
amounts deposited with or held by it or (iv) liable for the selection of
Permitted Investments or for investment losses incurred thereon. The
Collateral Agent shall have no liability in respect of losses incurred as a
result of the liquidation of any Permitted Investment prior to its stated
maturity or the failure of the Company to provide timely written investment
direction.
(c) The Collateral Agent shall be entitled to conclusively rely, and
shall be fully protected in relying, upon any writing, resolution, notice,
consent, certificate, affidavit, letter, telecopy, statement, order or other
document reasonably believed by it to be genuine and correct and to have
been signed, sent or made by the proper person or entity and upon advice and
statements of legal counsel, independent accountants and other experts
reasonably selected by the Collateral Agent. In connection with any request
of the Required Holders, the Collateral Agent shall be fully protected in
relying on a certificate of any Secured Party, reasonably believed by the
Collateral Agent to be signed by an authorized representative of such
Secured Party, setting forth the Secured Obligations held by such Secured
Party as of the date of such certificate, which certificate shall state that
the person signing such certificate is an authorized representative of such
Secured Party and shall state specifically which provision of this Agreement
pursuant to which the Collateral Agent is being directed to act. The
Collateral Agent shall be entitled to conclusively rely, and shall be fully
protected in relying, in good faith on such certificate. The Collateral
Agent shall be fully justified in failing or refusing to take any action
under this Agreement (i) if such action would, in the reasonable opinion of
the Collateral Agent, be contrary to law or the terms of this Agreement,
(ii) if such action is not specifically provided for in this Agreement, or
it shall not have received any such advice or concurrence of the Required
Holders as it deems appropriate or (iii) if, in connection with the taking
of any such action that would constitute an exercise of remedies under this
Agreement or the Note Purchase Agreement or is pursuant to a direction or
request of the Required Holders described in 2.2(e) hereof, it shall not
first be indemnified to its reasonable satisfaction by the Secured Parties
against any and all liability and expense which may be incurred by it by
reason of taking or
8
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continuing to take any such action. The Collateral Agent shall in all cases
be fully protected in acting, or in refraining from acting, under this
Agreement in accordance with a request of the Required Holders, and such
request and any action taken or failure to act pursuant thereto shall be
binding upon all the Secured Parties.
(d) If, with respect to a proposed action to be taken by it, the
Collateral Agent shall reasonably conclude in good faith that the provisions
of this Agreement relating to the functions or responsibilities or
discretionary powers of the Collateral Agent are or may be ambiguous or
inconsistent, the Collateral Agent shall notify the Secured Parties,
identifying the proposed action and the provisions that it considers are or
may be ambiguous or inconsistent, and may decline either to perform such
function or responsibility or to exercise such discretionary power unless it
has received the written confirmation of the Required Holders that the
Required Holders concur in the circumstances that the action proposed to be
taken by the Collateral Agent is consistent with the terms of this Agreement
or is otherwise appropriate. The Collateral Agent shall be fully protected
in acting or refraining from acting upon the confirmation of the Required
Holders in this respect, and such confirmation shall be binding upon the
Collateral Agent and the other Secured Parties.
(e) The Collateral Agent shall not be deemed to have knowledge or
notice of the occurrence of any Event of Default unless and until the
Collateral Agent has actual knowledge thereof or has received a written
notice or a certificate from a Secured Party or the Company stating that an
Event of Default has occurred. The Collateral Agent shall have no obligation
after receiving such notice or certificate to inquire whether an Event of
Default has in fact occurred and shall be entitled to rely conclusively, and
shall be fully protected in so relying, on any notice or certificate so
furnished to it. No provision of any Financing Document shall require the
Collateral Agent to expend or risk its own funds or otherwise incur any
financial liability in the performance of any of its duties thereunder or in
the exercise of any of its rights or powers, if it shall have reasonable
grounds for believing that repayment of such funds or adequate indemnity
against such risk or liability is not reasonably assured to it. In the event
that the Collateral Agent obtains actual knowledge of, or receives such a
notice of, the occurrence of any Event of Default, the Collateral Agent
shall give notice thereof to the Secured Parties. The Collateral Agent shall
take only such action with respect to such Event of Default as so directed
in writing by the Required Holders.
SECTION 2.3. INDEMNIFICATION AND FEES OF THE COLLATERAL AGENT.
(a) The Company shall indemnify the Collateral Agent and its directors,
officers, employees and agents from and against any and all claims, losses,
liabilities, obligations, actions, judgments, suits, damages, costs,
expenses and disbursements (including, without limitation, the reasonable
fees, expenses and disbursements of counsel) of any kind or nature
whatsoever that may at any time be incurred by the Collateral Agent
(hereinafter the "INDEMNIFICATION AMOUNT") growing out of or resulting from
(i) any Financing Document or any Collateral Document (including, without
limitation, the enforcement of any Financing Document or any Collateral
Document, but excluding any such claims, losses, liabilities, obligations,
actions, judgments, suits, damages, costs, expenses or disbursements
resulting from the Collateral Agent's gross negligence or willful misconduct
or resulting from any action brought by a Secured Party against the
Collateral Agent), (ii) any refund or adjustment of any amount paid or
payable to the Collateral Agent or any Secured Party under or in respect of
any Financing Document or any Collateral, or any interest thereon, which may
be ordered or otherwise required by any Person, except to the extent arising
out of the
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Collateral Agent's own gross negligence or its own willful misconduct, (iii)
the establishment of the Accounts, the acceptance of deposits, the purchase
or sale of instruments, investments or securities, the retention of cash and
instruments, investments or securities or the proceeds thereof and any
payment, transfer or other application of cash or instruments, investments
or securities by the Collateral Agent in accordance with the provisions of
this Agreement or the Note Purchase Agreement, or as may arise by reason of
any act, omission or error of the Collateral Agent made in good faith in the
conduct of its duties, except to the extent arising out of the Collateral
Agent's own gross negligence or willful misconduct or (iv) this Agreement
except to the extent arising out of the Collateral Agent's own gross
negligence or its own willful misconduct. If the Company fails to pay on
demand the Indemnification Amount, interest will accrue thereon at the
Default Rate from the scheduled date for payment thereof until the actual
date of payment and such interest shall be added to the Indemnification
Amount.
(b) The Company will pay upon demand to the Collateral Agent the amount
of any and all reasonable out-of-pocket expenses, including the reasonable
fees and expenses of its counsel (and any local counsel) and of any experts
and agents, which the Collateral Agent may incur in connection with (i) the
administration of any Financing Document, (ii) the custody or preservation
of, or the sale of, collection from, or other realization upon, any of the
Collateral, (iii) the exercise or enforcement (whether through negotiations,
legal proceedings or otherwise) of any of the rights of the Collateral Agent
or the Secured Parties under any Financing Document or any Collateral
Document or (iv) the failure by the Company or any other person or entity to
perform or observe any of the provisions of any Financing Document.
(c) The Company agrees to pay to the Collateral Agent an annual
collateral agency fee in advance, as agreed upon in writing by the Company
and the Collateral Agent, on each anniversary of the date of Closing
occurring during the period commencing on the date of Closing to and
including the date on which the Secured Obligations are paid in full (or on
such other dates as otherwise agreed by the Company and the Collateral
Agent).
(d) The provisions of this Section 2.3 shall survive termination of
this Agreement and the resignation or removal of the Collateral Agent.
SECTION 2.4. RESIGNATION OR REMOVAL OF THE COLLATERAL AGENT. The
Collateral Agent may resign upon not less than 30 days' prior written notice to
the Secured Parties and the Company and may be removed at any time with or
without cause by the Required Holders, with any such resignation or removal to
become effective only upon the appointment of a successor Collateral Agent under
this Section 2.4. If the Collateral Agent shall resign or be removed, then the
Required Holders shall (and if no such successor shall have been appointed
within 60 days of the Collateral Agent's resignation or removal, the Collateral
Agent may or may petition a court of competent jurisdiction to) appoint a
successor agent for the Secured Parties, which successor agent shall (i) be a
bank or trust company that has an office in New York, New York and that has a
combined capital and surplus of at least $500,000,000 and (ii) unless a Default
or Event of Default has occurred and is continuing, be reasonably acceptable to
the Company, whereupon such successor
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agent shall succeed to the rights, powers and duties of the "Collateral Agent"
and the term "Collateral Agent" shall mean such successor agent effective upon
its appointment, and the former Collateral Agent's rights, powers and duties as
Collateral Agent shall be terminated, without any other or further act or deed
on the part of such former Collateral Agent (except that the Collateral Agent
resigning or being removed shall deliver all Collateral then in its possession
to the successor Collateral Agent) or any of the other Secured Parties. After
any retiring Collateral Agent's resignation or removal hereunder, the provisions
of this Agreement shall inure to its benefit as to any actions taken or omitted
to be taken by it while it was the Collateral Agent.
SECTION 2.5. SUCCESSOR COLLATERAL AGENT. Any corporation into which the
Collateral Agent may be merged or converted or with which it may be
consolidated, or any corporation resulting from any merger, conversion or
consolidation to which the Collateral Agent shall be a party, or any corporation
succeeding to the business of the Collateral Agent shall be the successor of the
Collateral Agent hereunder, provided that corporation satisfies the eligibility
requirements specified in clause (i) of Section 2.4, without the execution or
filing of any paper with any party hereto or any further act on the part of any
of the parties hereto except where an instrument of transfer or assignment is
required by law to effect such succession, anything herein to the contrary
notwithstanding.
SECTION 2.6. CONSENTS UNDER COLLATERAL DOCUMENTS. Without the prior
written consent of the Required Holders, the Collateral Agent will not consent
to any amendment, restatement, modification, supplement or waiver under any of
the Collateral Documents, PROVIDED that, without the prior consent of each
Secured Party, the Collateral Agent shall not (except as provided herein), (i)
consent to the release of any Collateral or otherwise terminate any Lien
hereunder, (ii) agree to additional obligations being secured by such Lien
(other than as contemplated by Section 10 hereof) or (iii) alter the relative
priorities of the obligations entitled to the benefits of the Liens created
hereunder, except that no such consent shall be required, and the Collateral
Agent is hereby authorized, to consent to the release of any Lien covering
property that is the subject of either a disposition of property permitted
hereunder or a disposition to which the Required Holders have consented.
SECTION 2.7. DEPOSITARY BANK. The Depositary Bank shall be entitled to
the same rights, privileges and immunities as the Collateral Agent in connection
with its duties and obligations hereunder.
SECTION 3. THE ACCOUNTS.
SECTION 3.1. DEPOSITARY BANK; MAINTENANCE OF ACCOUNTS; LIMITED COMPANY
RIGHTS.
(a) DEPOSITARY BANK. For all purposes of this Agreement, any reference
herein to an application or disposition of Funds held in or credited to
either Account by the Collateral Agent shall be deemed to refer to an
application or disposition of such Funds by the Depositary Bank, and the
Collateral Agent agrees that it will cause the Depositary Bank to make all
applications and dispositions of Funds held in or credited to either Account
at such times and in such amounts as is required by the terms of this
Agreement.
(b) ACCEPTANCE OF PAYMENT ON MAINTENANCE OF ACCOUNTS. The Collateral
Agent
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hereby agrees to cause to be accepted by the Depositary Bank and the
Depositary Bank hereby agrees to accept all Funds to be delivered to or held
by the Collateral Agent pursuant to the terms of this Agreement. The Company
shall maintain the Accounts at the Depositary Bank during the term of this
Agreement. The Collateral Agent and the Depositary Bank hereby agree that
the Funds held in or credited to the Accounts shall be treated as "financial
assets" (as defined in Section 8-102(a)(9) of the UCC).
(c) LIMITED COMPANY RIGHTS. The Company shall not have any rights
against or to Funds held in or credited to the Accounts, as third party
beneficiary or otherwise, except the right to receive monies held in the
Accounts as permitted by Paragraph THIRD of Section 5.1 or to direct the
investment of Funds held in or credited to the Accounts as permitted by
Section 6. Except as expressly provided in this Agreement, in no event shall
any Permitted Investments deposited in or credited to any Account be
registered in the name of the Company, payable to the order of the Company
or specially indorsed to the Company except to the extent that the foregoing
have been specially indorsed to the Collateral Agent or in blank.
(d) ENTITLEMENT ORDERS. The Depositary Bank shall comply solely with
"entitlement orders" (within the meaning of Section 8-102(a)(8) of the UCC)
relating to any financial asset held in any Account without further consent
by the Company. Each of the Company and the Depositary Bank hereby
represents that it has not entered into, and hereby agrees that until the
payment in full of the Secured Obligations, it shall not enter into, any
agreement with any other Person (other than the Collateral Agent) relating
to the Accounts (or any Funds deposited therein or credited thereto)
pursuant to which the Depositary Bank has agreed or would agree, as the case
may be, to comply with entitlement orders made by such Person. Each of the
Company and the Depositary Bank hereby represents that it has not entered
into any other agreement with the Company or any other Person purporting to
limit or condition the obligation of the Collateral Agent or the Depositary
Bank to comply with entitlement orders as set forth in this Section 3.1(d).
SECTION 3.2. ESTABLISHMENT OF ACCOUNTS.
(a) The Collateral Agent will, prior to the date of Closing, establish
with the Depositary Bank the following special, segregated securities
accounts (the "ACCOUNTS"; each such Account being a "securities account" as
such term is defined in Section 8-501(a) of the UCC)) in the name of the
Collateral Agent, which shall be maintained at all times until the
termination of this Agreement:
1. the Collection Account; and
2. the Reserve Account.
(b) The Depositary Bank represents that the Accounts have been
established on the books and records of the Corporate Trust Department of
the Depositary Bank and that each such Account is a "securities account" (as
defined in section 8-501(a) of the UCC) in respect of which the Depositary
Bank is a "securities intermediary" (as defined in Section 8-102(a)(14) of
the UCC) and the Collateral Agent is the "entitlement holder" (as defined in
Section 8-102(a)(7) of the UCC). The Depositary Bank represents that the
"securities intermediary's jurisdiction"" (within the meaning of Section
8-110(e) of the UCC) of the Depositary Bank with respect to the
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Accounts is the State of New York.
(c) The account numbers of the Accounts established by, and in the name
of, the Collateral Agent will be notified by the Collateral Agent to the
Company and each Secured Party promptly upon the establishment thereof.
(d) All Funds from time to time deposited in or credited to each
Account shall be held in the name of the Collateral Agent for the benefit of
the Secured Parties in the custody of the Collateral Agent for the purposes
and on the terms set forth in this Agreement. All such Funds shall
constitute a part of the Collateral and shall not constitute payment of any
Indebtedness or any other obligation of the Company until applied as
hereinafter provided.
SECTION 4. DEPOSITS INTO ACCOUNTS.
SECTION 4.1. DEPOSIT OF ROYALTY PAYMENTS, ETC. All (i) Royalty Payments
payable to or for the benefit of the Company under the License Agreement and
(ii) all other amounts specified in Sections 7(c) and 7(d) shall be paid
directly to, and any such amounts received by the Company shall be deposited by
the Company with, on the day of receipt of such amounts, the Collateral Agent on
behalf of the Secured Parties for deposit in the Collection Account.
SECTION 4.2. NOTICE OF DEPOSITS TO COLLATERAL AGENT. Promptly after
obtaining knowledge that the Collateral Agent will receive funds for deposit
into the Collection Account, the Company shall notify the Collateral Agent that
the Collateral Agent will be receiving such funds and the approximate date of
such deposit and will specify the source of such funds.
SECTION 4.3. INITIAL DEPOSIT INTO RESERVE ACCOUNT. On the date of
Closing, the Company shall cause $600,000 to be deposited into the Reserve
Account.
SECTION 5. DISBURSEMENTS FROM ACCOUNTS.
SECTION 5.1. DISBURSEMENTS FROM THE COLLECTION ACCOUNT. On each Note
Payment Date, the Collateral Agent shall withdraw Funds from the Collection
Account for application in the following order of priority (such withdrawals to
be made not later than 11:00 a.m. (New York time) on such Note Payment Date and
only to the extent Funds are available therefor in the Collection Account):
FIRST, the Collateral Agent shall make pro rata payments of principal
of, interest on, and the Make-Whole Amount, if any, owing in respect
of, the Notes and all other Secured Obligations then due and owing;
SECOND, if the Reserve Account Balance is less than the Required
Reserve Balance as of such Note Payment Date, the Collateral Agent
shall transfer to the Reserve Account an amount of Funds equal to such
deficiency; and
THIRD, if (x) no Default or Event of Default has occurred and is
continuing and (y) the Royalty Payment Coverage Ratio is equal to or
greater than 1.25 to 1.00 as of the end of the fiscal quarter of the
Company ending on or immediately preceding such Note Payment Date (as
certified in the applicable Withdrawal Request), the Collateral Agent
shall transfer
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the balance, if any, of Funds held in or credited to the Collection
Account to the Company.
Not later than two Business Days prior to each Note Payment Date, the Company
shall provide the Collateral Agent with a Withdrawal Request specifying the
information needed to enable the Collateral Agent to calculate the amount of
Funds to be withdrawn from the Collection Account and applied in accordance with
this Section 5.1. Notwithstanding anything in this Section 5.1 to the contrary,
if the Company fails to deliver a Withdrawal Request for the transfer of funds
under this Section 5.1, the Collateral Agent is authorized upon the written
instructions of the Required Holders to make withdrawals from the Collection
Account for application in accordance with Paragraphs FIRST and SECOND above.
SECTION 5.2. DISBURSEMENTS FROM THE RESERVE ACCOUNT.
(a) On each Note Payment Date, if the aggregate amount of Funds
transferred by the Collateral Agent pursuant to Paragraph FIRST of Section
5.1 on such Note Payment Date is less than the aggregate amount of principal
of, interest on, and Make-Whole Amount, if any, payable in respect of, the
Notes and all other Secured Obligations due and owing as of such Note
Payment Date (prior to giving effect to such transfer), the Collateral Agent
shall withdraw Funds from the Reserve Account (such withdrawals to be made
not later than 11:00 a.m. (New York time) on such Note Payment Date and only
to the extent funds are available therefor) in an amount equal to such
deficiency and shall transfer such Funds to the applicable Secured Parties.
(b) On each Note Payment Date, in the event (after giving effect to the
transfers referred to above) the Reserve Account Balance exceeds the
Required Reserve Balance, the Collateral Agent shall withdraw from the
Reserve Account and deposit in the Collection Account the amount of Funds
equal to such excess.
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SECTION 5.3. TRANSFERS WHEN AN EVENT OF DEFAULT IS CONTINUING. Upon
receipt by the Collateral Agent of written notice that an Event of Default has
occurred and is continuing, the Collateral Agent shall make transfers from the
Accounts in accordance with Section 9.
SECTION 5.4. DISPOSITION OF ACCOUNTS UPON PAYMENT OF SECURED
OBLIGATIONS. Upon final indefeasible payment in full of the Secured Obligations,
the Collateral Agent shall hold all Funds held in or credited to the Accounts to
the order of the Company or as otherwise required by applicable law.
SECTION 6. PERMITTED INVESTMENTS. Upon the request of the Company, the
Collateral Agent shall invest and reinvest any Funds held in or credited to
either Account from time to time in Permitted Investments as instructed by the
Company; PROVIDED, that (a) if the Company fails to so instruct the Collateral
Agent or upon the occurrence and continuance of an Event of Default, the
Collateral Agent shall invest and reinvest such Funds in Permitted Investments
of the type described in clause (e) of the definition of such term or as
otherwise directed by the Required Holders and (b) the maturity of any Permitted
Investment shall not exceed 270 days (or, in the case of any Permitted
Investment held in or credited to the Collection Account, the maturity thereof
shall not extend beyond the Business Day immediately preceding the Note Payment
Date next succeeding the date of acquisition thereof). Earnings on Permitted
Investments held in or credited to each Account shall be deposited in such
Account for application as provided for herein. All such investments and
reinvestments shall be held in the name, and shall be under the sole dominion
and control, of the Collateral Agent. All Funds held in or credited to either
Account that are invested in a Permitted Investment are deemed to be held in
such Account for all purposes of this Agreement. The Collateral Agent shall have
no liability for any loss in investment of Funds held in or credited to either
Account invested in Permitted Investments.
SECTION 7. COLLATERAL. As collateral security for the prompt payment in
full when due (whether at stated maturity, by acceleration or otherwise) of the
Secured Obligations, now existing or hereafter arising, the Company hereby
pledges, hypothecates, assigns, and transfers to the Collateral Agent for the
equal and ratable benefit of the Secured Parties, and hereby grants to the
Collateral Agent for the equal and ratable benefit of the Secured Parties a
security interest in, all of the Company's right, title and interest in, to and
under the following property, whether now owned by the Company or hereafter
acquired and whether now existing or hereafter coming into existence and
wherever located (all being collectively referred to herein as "COLLATERAL"):
(a) each Account and all Funds held in or credited to each thereof;
(b) all cash, investments and securities at any time on deposit in any
Account, including all income or gain earned thereon and any proceeds
thereof;
(c) all Royalty Payments and all rights of the Company to receive
moneys due and to become due under or pursuant to the License Agreement with
respect thereto;
(d) the proceeds of any judgments, settlements or other payments in
connection with the BMG Litigation or any other litigation, arbitration or
other legal proceeding relating to the Royalty Payments; and
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(e) without limiting the provisions of the preceding clauses of this
Section 7, all proceeds, products, accessions, benefits, substitutions and
replacements of and to any of the property of the Company described in the
preceding clauses of this Section 7.
SECTION 8. FURTHER ASSURANCES; REMEDIES. In furtherance of the grant of
the pledge and security interest pursuant to Section 7, the Company hereby
agrees with each Secured Party as follows:
SECTION 8.1. DELIVERY AND OTHER PERFECTION. The Company shall:
(a) give, execute, deliver, file and record any financing statement,
notice, instrument, document, agreement or other papers that may be
necessary or desirable (in the judgment of the Collateral Agent) to create,
preserve, perfect or validate the security interest granted pursuant hereto
or to enable the Collateral Agent to exercise and enforce its rights
hereunder with respect to such pledge and security interest;
(b) keep full and accurate books and records relating to the
Collateral, and stamp or otherwise mark such books and records in such
manner as the Collateral Agent may reasonably require in order to reflect
the security interests granted by this Agreement; and
(c) permit representatives of the Collateral Agent, upon reasonable
notice, at any time during normal business hours to (i) inspect and make
abstracts from its books and records pertaining to the Collateral and (ii)
be present at the Company's place of business to receive copies of all
communications and remittances relating to the Collateral, and forward
copies of any notices or communications received by the Company with respect
to the Collateral, all in such manner as the Collateral Agent may reasonably
require.
SECTION 8.2. OTHER FINANCING STATEMENTS AND LIENS. The Company shall
not file or suffer to be on file, or authorize or permit to be filed or to be on
file, in any jurisdiction, any financing statement or like instrument with
respect to the Collateral in which the Collateral Agent is not named as the sole
secured party for the benefit of the Secured Parties.
SECTION 8.3. PRESERVATION OF RIGHTS. The Collateral Agent shall not be
required to take steps necessary to preserve any rights against prior parties to
any of the Collateral.
SECTION 8.4. SPECIAL PROVISIONS RELATING TO LICENSE AGREEMENT.
(a) Anything herein to the contrary notwithstanding, the Company shall
remain liable to perform all of its duties and obligations under the License
Agreement and in respect of the Collateral to the same extent as if this
Agreement had not been executed. The exercise by the Collateral Agent or any
other Secured Party of any of the rights and remedies hereunder shall not
release the Company from any of its duties or obligations under the License
Agreement or in respect of the Collateral. Neither the Collateral Agent nor
any of the other Secured Parties shall have any obligation or liability
under the License Agreement or otherwise in respect of the Collateral by
reason of this Agreement or be obligated to perform any of the obligations
or duties of the Company under the License Agreement or otherwise in respect
of the Collateral or to take
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any action to collect or enforce any claim for payment or any other right
assigned hereunder.
(b) The Company will at all times maintain instructions with BMG
directing BMG to make all Royalty Payments directly to the Collection
Account.
(c) If the Company fails to perform any agreement contained herein, the
Collateral Agent may, with reasonable notice to the Company, itself perform,
or cause the performance of, such agreement, and the reasonable expenses of
the Collateral Agent incurred in connection therewith shall be payable by
the Company and shall be Secured Obligations to the Collateral Agent secured
under Section 7.
SECTION 8.5. EVENTS OF DEFAULT, ETC.During the period during which an
Event of Default shall have occurred and be continuing:
(i) the Collateral Agent may make any reasonable compromise or
settlement deemed desirable with respect to any of the Collateral and
may extend the time of payment, arrange for payment in installments, or
otherwise reasonably modify the terms of, any of the Collateral;
(ii) the Collateral Agent shall have all of the rights and
remedies with respect to the Collateral of a secured party under the
UCC (whether or not the UCC is in effect in the jurisdiction where the
rights and remedies are asserted) and such additional rights and
remedies to which a secured party is entitled under the laws in effect
in any jurisdiction where any rights and remedies hereunder may be
asserted, including, without limitation, the right, to the maximum
extent permitted by law, to exercise all voting, consensual and other
powers of ownership pertaining to the Collateral as if the Collateral
Agent were the sole and absolute owner thereof (and the Company agrees
to take all such action as may be appropriate to give effect to such
right);
(iii) the Collateral Agent may, in its name or in the name of the
Company or otherwise, demand, sue for, collect or receive any money or
property at any time payable or receivable on account of or in exchange
for any of the Collateral, but shall be under no obligation to do so;
(iv) the Collateral Agent may, upon 10 Business Days' prior notice
to the Company of the time and place, with respect to the Collateral or
any part thereof which shall then be or shall thereafter come into the
possession, custody or control of the Collateral Agent, the other
Secured Parties or any of their respective agents, sell, lease, assign
or otherwise dispose of all or any part of such Collateral, at such
place or places as the Collateral Agent deems best, and for cash or for
credit or for future delivery (without thereby assuming any credit
risk), at public or private sale, without demand of performance or
notice of intention to effect any such disposition or of the time or
place thereof (except such notice as is required above or by applicable
statute and cannot be waived), and the Collateral Agent or any other
Secured Party or anyone else may be the purchaser, lessee, assignee or
recipient of any or all of the Collateral so disposed of at any public
sale (or, to the extent permitted by law, at any private sale) and
thereafter hold the same absolutely,
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free from any claim or right of whatsoever kind, including any right or
equity of redemption (statutory or otherwise), of the Company, any such
demand, notice and right or equity being hereby expressly waived and
released; and the Collateral Agent may, without notice or publication,
adjourn any public or private sale or cause the same to be adjourned
from time to time by announcement at the time and place fixed for the
sale, and such sale may be made at any time or place to which the sale
may be so adjourned; and
(v) The Collateral Agent's and any Secured Party's sole duty with
respect to the custody, safekeeping and physical preservation of the
Collateral in its possession, under Section 9-207 of the UCC or
otherwise, shall be to deal with it in the same manner as the
Collateral Agent or such Secured Party deals with similar property for
its own account. None of the Collateral Agent or the Secured Parties,
nor their respective directors, officers, employees, or agents, shall
be liable to the Company for failure to demand, collect or realize upon
any of the Collateral or for any delay in doing so or shall be under
any obligation to sell or otherwise dispose of any of the Collateral
upon the request of the Company or any other Person or to take any
other action whatsoever with regard to the Collateral or any part
thereof. The rights of the Collateral Agent and the Secured Parties
hereunder shall not be conditioned or contingent upon the pursuit by
the Collateral Agent or any Secured Party of any right or remedy
against the Company or against any other Person which may be or become
liable in respect of all or any part of the Secured Obligations or
against any collateral security therefor, guarantee thereof or right of
offset with respect thereto.
The proceeds of each collection or other disposition under this Section
8.5 shall be applied in accordance with Section 9.
SECTION 8.6. REMOVALS, ETC.Without at least 30 days' prior notice to
the Collateral Agent, the Company shall not (a) maintain any of its Records at
any office or maintain its principal place of business at any place other than
at the address specified in Section 5.21 of the Note Purchase Agreement or (b)
change its name, or the name under which it does business, from the name shown
on the signature pages hereto.
SECTION 8.7. PRIVATE SALE.The Collateral Agent and the other Secured
Parties, respectively, shall incur no liability as a result of the sale of the
Collateral, or any part thereof, at any private sale, pursuant to Section 8.5,
conducted in a commercially reasonable manner. The Company hereby waives any
claims against the Collateral Agent or any other Secured Party arising by reason
of the fact that the price at which the Collateral may have been sold at such a
private sale was less than the price which might have been obtained at a public
sale or was less than the aggregate amount of the Secured Obligations, even if
the Collateral Agent accepts the first offer received and does not offer the
Collateral to more than one offeree.
SECTION 8.8. ATTORNEY-IN-FACT.Without limiting any rights or powers
granted by this Agreement to the Collateral Agent while no Event of Default has
occurred and is continuing, upon the occurrence and during the continuance of
any Event of Default the Collateral Agent is hereby appointed the
attorney-in-fact of the Company for the purpose of carrying out the provisions
of this Section 8
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and taking any action and executing any instruments which the Collateral Agent
may reasonably deem necessary or advisable to accomplish the purposes hereof,
which appointment as attorney-in-fact is irrevocable and coupled with an
interest. Without limiting the generality of the foregoing, so long as the
Collateral Agent shall be entitled under this Section 8 to make collections in
respect of the Collateral, the Collateral Agent shall have the right and power,
with reasonable notice to the Company, to receive, endorse and collect all
checks made payable to the order of the Company representing any dividend,
payment or other distribution in respect of the Collateral or any part thereof
and to give full discharge for the same.
SECTION 8.9. PERFECTION.Prior to or concurrently with the execution and
delivery of this Agreement, the Company shall deliver to the Collateral Agent in
form for filing such financing statements and other documents in such offices as
the Collateral Agent may reasonably request to perfect the security interests
granted by Section 3 of this Agreement. The Company hereby authorizes the
Collateral Agent to file one or more financing or continuation statements, and
amendments thereto, relating to all or any part of the Collateral without the
signature of the Company where permitted by law.
SECTION 8.10. TERMINATION OF SECURITY INTEREST.When all Secured
Obligations shall have been finally and indefeasibly paid in full, the security
interest created by this Agreement shall terminate and the Collateral Agent
shall forthwith cause to be assigned, transferred and delivered, against receipt
but without any recourse, warranty or representation whatsoever, any remaining
Collateral and money received in respect thereof, to or on the order of the
Company.
SECTION 8.11. EXPENSES.The Company agrees to reimburse each of the
Secured Parties and the Collateral Agent for all costs and expenses of the
Secured Parties and the Collateral Agent (including, without limitation, the
fees and expenses of legal counsel) in connection with (a) any Event of Default
and any enforcement or collection proceeding resulting therefrom, including,
without limitation, all manner of participation in or other involvement with (i)
performance by the Collateral Agent of any obligation that the Company has
failed or refused to perform, (ii) bankruptcy, insolvency, receivership,
foreclosure, winding up or liquidation proceedings, or any actual or attempted
sale, or any exchange, enforcement, collection, compromise or settlement in
respect of any of the Collateral, and for the care of the Collateral and
defending or asserting rights and claims of the Collateral Agent in respect
thereof, by litigation or otherwise, including expenses of insurance, (iii)
judicial or regulatory proceedings, (iv) workout, restructuring or other
negotiations or proceedings (whether or not the workout, restructuring or
transaction contemplated thereby is consummated) and (v) enforcement proceedings
hereunder in respect of the Collateral and (b) the enforcement of this Section
8.11, and all such costs and expenses shall be Secured Obligations entitled to
the benefits of the collateral security provided pursuant to Section 7.
SECTION 8.12. FURTHER ASSURANCES.The Company agrees that, from time to
time upon the request of the Collateral Agent, the Company will execute and
deliver such further documents and do such other acts and things as the
Collateral Agent may reasonably request in order fully to effectuate the
purposes of this Agreement.
SECTION 9. APPLICATION OF PROCEEDS.After an Event of Default has
occurred and is continuing, except as otherwise expressly provided herein, the
proceeds of any collection, sale or
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other realization of all or any part of the Collateral pursuant to any
Collateral Document, and any Funds held in or credited to the Accounts and cash
at the time held by the Collateral Agent under this Section 9 shall be
distributed by the Collateral Agent at the times specified in the following
order of priority:
FIRST, to the Collateral Agent in an amount equal to (a) the cost of
any indemnity to be provided to the Collateral Agent in respect of the
enforcement of any of the rights of the Collateral Agent or other
Secured Parties under the Collateral Documents and (b) the fees and
expenses of the Collateral Agent then due and owing;
SECOND, to the Secured Parties in an amount equal to the fees and
expenses (including counsel fees and expenses) of the Secured Parties
in respect of the enforcement of any of the rights of the Secured
Parties under the Financing Documents to the extent permitted by such
documents;
THIRD, to the Noteholders in an amount equal to the unpaid interest on
the Notes, whether or not then due and owing and, in case such proceeds
shall be insufficient to pay in full such interest, then to the payment
thereof ratably (without priority of any one over any other) in
proportion to the unpaid amounts thereof on the relevant date;
FOURTH, to the Noteholders in an amount equal to the unpaid principal
of the Notes whether or not then due and owing and, in case such
proceeds shall be insufficient to pay in full such principal, then to
the payment thereof ratably (without priority of any one over any
other) in proportion to the unpaid amounts thereof on the relevant
date;
FIFTH, to the Secured Parties in an amount equal to all other Secured
Obligations due such Secured Parties under the Financing Documents and,
in case such proceeds shall be insufficient to pay in full such Secured
Obligations, then to the payment thereof ratably (without priority of
any one over any other) in proportion to the unpaid amounts thereof on
the relevant date; and
SIXTH, after payment in full of all Secured Obligations, any surplus
then remaining shall be transferred to the Company or its successors or
assigns, or to whomever may be lawfully entitled to receive the same,
or as a court of competent jurisdiction may direct.
As used in this Section 9, "proceeds" of Collateral shall mean cash, securities
and other property realized in respect of, and distributions in kind of,
Collateral, including any such amounts received under any reorganization,
liquidation, or adjustment of debt of the Company.
SECTION 10. ADDITIONAL SECURED INDEBTEDNESS.If the Company shall at any
time desire to incur any additional Secured Indebtedness in compliance with the
provisions of Section 10.6 of the Note Purchase Agreement, the Company shall
give written notice thereof to the Collateral Agent and the other Secured
Parties, and any such notice shall include calculations in reasonable detail
demonstrating that the incurrence of such Indebtedness (on the proposed date of
issuance thereof) will comply with the requirements of Section 10.6 of the Note
Purchase Agreement. Upon receipt of any such notice, the Collateral Agent and
the Secured Parties agree to execute and deliver such further instruments
(including an amendment to this Agreement) and do such other acts and things as
may be reasonably required to cause the Lien created by this Agreement
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to equally and ratably secure the obligations of the Company in respect of such
additional Secured Indebtedness.
SECTION 11. MISCELLANEOUS.
SECTION 11.1. NO WAIVER.No failure on the part of the Collateral Agent
to exercise, no course of dealing and no delay in exercising any right, power or
remedy under this Agreement shall operate as a waiver thereof, and no single or
partial exercise of any right, power or remedy under this Agreement shall
preclude any other or further exercise thereof or the exercise of any other
right, power or remedy. The remedies provided herein are cumulative and not
exclusive of any remedies provided by law.
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SECTION 11.2. SEVERABILITY.Any provision of this Agreement that is
prohibited or unenforceable in any jurisdiction shall, as to such jurisdiction,
be ineffective to the extent of such prohibition or unenforceability without
invalidating the remaining provisions hereof, and any such prohibition or
unenforceability in any jurisdiction shall (to the full extent permitted by law)
not invalidate or render unenforceable such provision in any other jurisdiction.
SECTION 11.3. SUCCESSORS AND ASSIGNS.This Agreement shall bind and
inure to the benefit of and be enforceable by the Company, the Collateral Agent
and the other Secured Parties and their respective permitted successors and
assigns hereunder and, in addition, shall inure to the benefit of and be
enforceable by all Secured Parties from time to time; provided, however, that
the Company shall not assign or transfer its rights or obligations hereunder
without the prior written consent of the Required Holders.
SECTION 11.4. COUNTERPARTS.This Agreement may be executed in any number
of counterparts, each of which shall be an original but all of which together
shall constitute one instrument. Each counterpart may consist of a number of
copies hereof, each signed by less than all, but together signed by all, of the
parties hereto.
SECTION 11.5. AMENDMENT, WAIVER, ETC.No amendment or waiver of any
provision of this Agreement shall be effective unless the same shall be in
writing and signed by the Collateral Agent, the Required Holders and the
Company, and any such waiver or consent shall be effective only in the specific
instance and for the specific purpose for which given (PROVIDED that (i) no
amendment, modification or waiver shall, unless by an instrument signed by all
of the Secured Parties or by the Collateral Agent acting with the consent of all
of the Secured Parties, amend or waive Sections 2.3, 5 or 9 or this Section
11.5).
SECTION 11.6. HEADINGS. The table of contents and captions and section
headings appearing herein are included solely for convenience of reference and
are not intended to affect the interpretation of any provision of this
Agreement.
SECTION 11.7. NOTICES.All notices, requests, consents and demands
hereunder shall be in writing and telecopied or delivered to the intended
recipient at its "Address for Notices" specified pursuant to Section 18 of the
Note Purchase Agreement or, if to the Collateral Agent or the Depositary Bank,
at the "Address for Notices" specified below its name on the signature pages
hereof or, as to any party, at such other address as shall be designated by such
party in a notice to each other party, and in any case, shall be deemed to have
been given at the times specified in said Section 18.
SECTION 11.8. REINSTATEMENT.This Agreement and any Lien created
hereunder shall automatically be reinstated if and to the extent that for any
reason any payment by or on behalf of the Company in respect of the Secured
Obligations is rescinded or must otherwise be restored by any Secured Party,
whether as a result of any proceedings in bankruptcy or reorganization or
otherwise, and the Company shall indemnify the Collateral Agent and each other
Secured Party on demand for all reasonable costs and expenses (including,
without limitation, reasonable fees and expenses of counsel) incurred by the
Collateral Agent or such other Secured Party in connection with such rescission
or restoration.
SECTION 11.9. TERMINATION.
22
<PAGE>
This Agreement shall remain in full force and effect until all Secured
Obligations shall have been finally and indefeasibly paid in full. The
provisions of Section 2.3 shall survive any termination of this Agreement.
SECTION 11.10. NO THIRD PARTY BENEFICIARIES. The agreements of the
parties hereto are solely for the benefit of the Company, the Collateral Agent
and the Secured Parties, and no Person (other than the Secured Parties and their
successors and permitted assigns hereunder) shall have any rights hereunder.
SECTION 11.11. GOVERNING LAW. This agreement shall be governed by and
construed in accordance with the law of the State of New York (excluding choice
of law principles of the law of such State that would require the application of
the law of a jurisdiction other than such State).
23
<PAGE>
IN WITNESS WHEREOF, the Company, each Purchaser, the Collateral Agent
and the Depositary Bank have caused this Agreement to be duly executed by their
duly authorized officers all as of the date first above written.
IGEN INTERNATIONAL, INC.
By:
--------------------------------
Title:
BANKERS TRUST COMPANY,
as Collateral Agent
By:
--------------------------------
Name:
Title:
Address for Notices:
Bankers Trust Company
Corporate Trust & Agency Services
Four Albany Street
10th Floor
New York, New York 10006
Telephone No.: 212-250-6137
Facsimile No.: 212-250-6439
Attention: Structured Finance
BANKERS TRUST COMPANY,
as Depositary Bank
By:
--------------------------------
Name:
Title:
Address for Notices:
Bankers Trust Company
Corporate Trust & Agency Services
Four Albany Street
10th Floor
New York, New York 10006
Telephone No.: 212-250-6137
Facsimile No.: 212-250-6439
Attention: Structured Finance
24
<PAGE>
EXHIBIT 23.1
INDEPENDENT AUDITOR'S CONSENT
We consent to the incorporation by reference in Registration Statements No.
33-77132 and 333-45355 of IGEN International, Inc. on Form S-8 dated March
31,1994 and Form S-3 dated April 15, 1998 of our report dated May 10, 1999,
appearing in this Annual Report on Form 10-K of IGEN International, Inc. for the
year ended March 31, 1999.
DELOITTE & TOUCHE LLP
Washington, DC
June 25, 1999
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