UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
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: July 9, 2003):
IGEN INTERNATIONAL, INC.
(Exact name of registrant as specified in its charter)
Delaware 0-23252
(State or other Jurisdiction of (Commission File Number)
Incorporation)
94-2852543
( I.R.S. Employer Identification No.)
16020 Industrial Drive
Gaithersburg, Maryland 20877
(Principal Executive Office) (Zip Code)
Registrant's telephone number, including area code: (301) 869-9800
Exhibit Index on Page 4
Item 5. Other Events
On July 9, 2003, IGEN International, Inc. ("IGEN") announced that the U.S. Court
of Appeals for the Fourth Circuit affirmed IGEN's right to terminate the License
and Technology Development Agreement dated as of September 23, 1992 (the
"License Agreement"), between IGEN and Roche Diagnostics GmbH ("Roche"), a
division of F. Hoffman-LaRoche. IGEN has notified Roche that the License
Agreement has terminated. The Court of Appeals also affirmed IGEN's right to
certain improvements developed by Roche under the License Agreement, including
Roche's Elecsys(R) diagnostics product line.
In addition, the Court of Appeals reversed the portion of the judgment that held
Roche liable for unfair competition, thus vacating the $400 million punitive
damage award against Roche. The ruling also reversed $86.8 million in
compensatory damages and left intact IGEN's right to over $18 million in
compensatory damages for unpaid royalties, out-of-field-sales and withholding of
improvements.
Termination of the License Agreement ends Roche's rights under the license from
IGEN to manufacture, market, and sell ORIGEN-based products, including its
Elecsys 1010 and 2010 instruments and assays. In addition, Roche is no longer
licensed to sell the Elecsys E170 product line, which has been integrated into
Roche's MODULAR ANALYTICS system. This system couples together Roche's clinical
chemistry systems with the Elecsys E170 immunoassay systems and a series of
other modules. In addition, IGEN will receive specified rights to certain
improvements relating to the Elecsys product line, as well as to certain other
improvements licensed, owned or developed by Roche, including PCR, a nucleic
acid amplification technology.
Also on July 9, 2003, IGEN filed patent infringement lawsuits against Roche in
the United States and Germany to ensure that Roche ceases any further sales of
products that incorporate IGEN's ORIGEN technology. IGEN filed an action in the
U.S. District Court for the District of Maryland seeking a finding that Roche is
infringing IGEN's ORIGEN patents, as well as a preliminary and permanent
injunction against Roche's further infringement of those patents. A similar
lawsuit was simultaneously filed in Germany.
A copy of the opinion can be found on the website of the U.S. Court of Appeals
for the Fourth Circuit at http://pacer.ca4.uscourts.gov/opinion.pdf/021537.P.pdf
IGEN also intends to post a copy of the opinion on its website at www.igen.com
and will file it with the SEC as soon as reasonably practicable.
Cautionary Note About Forward-Looking Statements
This Form 8-K contains forward-looking statements within the meaning of the
"safe harbor" provision of the Private Securities Litigation Reform Act of 1995.
All statements that are not statements of historical fact are forward-looking
statements. The words "may," "should," "will," "expect," "could," "anticipate,"
"believe," "estimate," "plan," "intend" and similar expressions have been used
to identify certain of the forward-looking statements in this Form 8-K. We have
based these forward-looking statements on management's current expectations,
estimates and projections and they are subject to a number of risks,
uncertainties and assumptions which could cause actual results to differ
materially from those described in the forward-looking statements. The following
factors are among those that may cause actual results to differ materially from
our forward-looking statements: the outcome of the Roche litigation and our
relationship with Roche Diagnostics GmbH; our ability to develop and introduce
new or enhanced products; our ability to enter into new collaborations on
favorable terms, if at all; our ability to expand the commercialization of
existing products; our ability to expand our manufacturing capabilities or find
a suitable manufacturer on acceptable terms or in a timely manner; our ability
to develop our selling, marketing and distribution capabilities; our and our
licensees' ability to obtain FDA and other governmental approvals for our and
their clinical testing products; the ability of our licensees to effectively
develop and market products based on the technology we license to them; domestic
and foreign governmental and public policy changes, particularly related to
health care costs, that may affect new investments and purchases made by
customers; availability of financing and financial resources in the amounts, at
the times and on the terms required to support our future business; rapid
technological developments in each of our markets and our ability to respond to
those changes in a timely, cost-effective manner; protection and validity of
patent and other intellectual property rights; and changes in general economic,
business and industry conditions. These and other risk factors are discussed in
IGEN's annual report on Form 10-K for the year ended March 31, 2003, filed with
the Securities and Exchange Commission (SEC) and available at the Investor
Relations section of IGEN's web site at www.igen.com or the SEC's web site at
www.sec.gov. IGEN disclaims any intent or obligation to update any forward
looking statements.
Item 9. Regulation FD Disclosure
On July 9, 2003, IGEN issued the press release attached to this Form 8-K as
Exhibit 99.1, announcing the decision of the U.S. Court of Appeals for the
Fourth Circuit in IGEN's litigation with Roche. The information provided in Item
9 of this Form 8-K, including Exhibit 99.1, shall not be deemed to be
incorporated by reference into IGEN's filings with the SEC under the Securities
Act of 1933.
EXHIBIT INDEX
Exhibit No. Description
99.1 Press Release issued by the registrant, dated July 9, 2003.
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.
Date: July 10, 2003
IGEN INTERNATIONAL, INC.
By: /s/ George V. Migausky
----------------------
Name: George V. Migausky
Title: Vice President and Chief Financial
Officer (Principal Accounting Officer)