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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 8-K
CURRENT REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported) September 20,2000
Commission File Number 0-23252
IGEN INTERNATIONAL, INC.
(Exact name of registrant)
Delaware 94-2852543
(State of organization) (I.R.S. Employer Identification No)
16020 Industrial Drive, Gaithersburg Maryland 20877
(Address of principal executive offices and zip code)
(301) 869-9800
(Registrant's telephone Number)
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ITEM 5. OTHER EVENTS
DISTRIBUTION AGREEMENT WITH SC BIOSCIENCE CORPORATION
On October 2, 2000, IGEN International, Inc. (the "Company")
announced that it has signed a five year nonexclusive distribution agreement
with SC BioScience Corp., a subsidiary of Sumitomo Corp., under which SC
BioScience will distribute the Company's M-SERIES-TM- M8 biological detection
system in the life science market in Japan.
The agreement contemplates that SC BioScience will purchase a minimum
of $15.4 million of M8 instruments for distribution in Japan to pharmaceutical
companies and other life science customers. In addition, the Company and its
IGEN KK subsidiary will be responsible for the marketing and selling of all
consummable reagents and assays for these instruments in the Japanese market,
and SC BioScience has agreed to provide support and services to facilitate that
effort.
M SERIES INITIATIVES
As previously reported by the Company, it has been in the process of
upgrading M SERIES M8 hardware and software to address instrument performance
issues that were being experienced by customers in the field. The Company's
software upgrade has been released, and installation in customers' systems is
substantially complete. Previously identified hardware performance issues were
resolved and the Company instituted an upgrade program to retrofit systems in
the field with newly designed components. During this upgrade process, the
Company identified additional upgrade requirements that are being addressed
through a variety of measures. In addition, the Company is implementing a
quality program designed to continuously improve and enhance system
reliability and performance as time goes on.
RISK FACTORS AND FORWARD LOOKING STATEMENTS
The Company believes that these efforts will satisfactorily address a
significant portion of the current performance issues associated with the
instruments. There can be no assurance, however, that the initiatives taken by
the Company will satisfactorily resolve existing performance issues, that the
issues, if resolved, will not reoccur, that new instrumentation problems will
not arise as the number of systems being placed with customers continues to
increase, that there will not be future product issues, or that customer
satisfaction and existing and future orders will not be adversely affected by
these issues. In addition, there can be no assurance that the performance issues
will not adversely affect the Company's ability to market and sell its existing
product line or that these issues or any other issues will not have an adverse
impact on the Company's future results of operations or financial condition.
This report contains forward-looking information, including
statements about the magnitude of contemplated sale of products for distribution
in Japan, the use of the M8 system in pharmaceutical R&D, the ability of the
Company to resolve performance issues in its instrumentation and systems and
avoid such issues in the future. The factors that affect the ability
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of the Company to successfully market and distribute products in Japan include,
among others, the resources committed by its distributor in the territory, the
acceptance by customers of the Company's proprietary ORIGEN technology, the
performance of the instruments and reagents as compared to competing systems,
among others. The factors that affect the ability of the Company to resolve the
instrument performance issues include, among others, the consistency of the
quality of the materials and parts provided by suppliers, customer's knowledge
and understanding of the instrumentation and system, compliance by customers
with recommended service and performance guidelines, and the ability to identify
the causes of specific instrumentation issues in the hands of specific
customers.
A more complete description of the risks applicable to the Company
appears in the Company's documents filed with the Securities and Exchange
Commission. In particular, careful consideration should be given to the
cautionary statements and risk factors noted in the Company's Annual Report
on Form 10-K and quarterly reports on Form 10-Q. The Company disclaims any
intent or obligation to continuously update these forward-looking statements.
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
IGEN INTERNATIONAL, INC.
By: /s/ Samuel J. Wohlstadter
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Samuel J. Wohlstadter
Chairman of the Board &
Chief Executive Officer
Dated: October 2, 2000
