--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 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) January 10, 2002 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)
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
ITEM 5. OTHER EVENTS
On January 10, 2002, a jury has awarded IGEN International, Inc. (the
"Company") $505 million in damages in its case against Roche Diagnostics, GmbH.
("Roche"), an affiliate of F. Hoffmann-La Roche. The jury also confirmed the
Company's rights to Roche's Elecsys(R) diagnostics product line, which was
developed by Roche using the Company's proprietary ORIGEN biological detection
technology, as well as to other improvements. In addition, the jury's findings
permit the Company to terminate its license agreement with Roche, which allows
Roche to use ORIGEN in its diagnostics products.
Following a 10-week jury trial before the U.S. District Court for the
District of Maryland, an 11-member jury unanimously found Roche to have
materially breached the license agreement, violated its duty to the Company of
good faith and fair dealing, and engaged in unfair competition against the
Company. The jury ordered Roche to pay the Company $105 million in compensatory
damages and $400 million in punitive damages.
The jury also confirmed the Company's right to Roche products,
including the Elecsys(R) 1010, 2010 and E170 lines of clinical diagnostic
immunoassay analyzers and the tests developed for use on those systems
(including tests for thyroid and reproductive hormones and markers for cancer,
cardiac disease, and osteoporosis). The Company is also entitled to certain
other technologies owned or developed by Roche, including PCR, a nucleic acid
amplification technology.
In their verdict, the 11-member jury unanimously found Roche breached the
license agreement by:
|_| Failing to keep full and accurate records necessary to calculate royalties
due to the Company, by improperly calculating royalties, by failing to
provide full, accurate and comprehensible sales reports and /or by
underpaying royalties.
|_| Placing products based on the Company's technology with customers other
than hospitals, clinical reference laboratories and blood banks, the only
fields permitted by the agreement.
|_| Failing to ensure full compliance with the license agreement by Roche's
numerous affiliate sublicensees.
|_| Failing to comply with the implied duty of good faith and fair dealing by
failing to return to the Company the rights to DNA probe assays for
ORIGEN-based systems.
|_| Failing to provide the Company with improvements such as instruments and
assays, as obligated by the agreement.
The Court had previously granted summary judgment in the Company's favor on
four additional breach of contract claims:
|_| Taking unsubstantiated "rental surcharge" deductions against reported sales
of royalty-bearing products.
|_| Settling a patent infringement suit with a third party without the
Company's consent.
|_| Improving certain products after the launch of the Elecsys 2010 system.
|_| Failing to inform the Company of patent filings and/or to provide copies of
patent applications in a timely manner.
The Company expects post-trial motions will be filed and that Roche will
appeal various decisions in this case. The jury's decisions, including the
Company's right to terminate the license agreement, would be effective once
affirmed on appeal. During an appeal process, which the Company expects could
take approximately 18 months, the Company will continue to receive royalties on
Roche's sales of royalty-bearing products under the license.
The jury also found in the Company's favor and against Roche on all of
Roche's counterclaims, except for one in which the Company was ordered to pay
five hundred thousand dollars.
In addition to historical information, this document contains
forward-looking statements within the meaning of the "safe-harbor" provisions of
the Private Securities Litigation Reform Act of 1995. Reference is made in
particular to statements regarding the potential timing for the filing and
completion of, and prospects for ultimate resolution of, any appeal of the
litigation, the commercial viability of the Company's technology and the
improvements awarded to the Company, and its future growth prospects. Actual
results might differ materially from these statements due to risks and
uncertainties, including the risk that some or all of the judgments awarded by
the jury may be reduced or otherwise adversely affected by future decisions that
may be made by the courts. A more complete description of the risks applicable
to the Company appear in the Company's documents filed with the Securities and
Exchange Commission and available on request from the Company. The Company
disclaims any intent or obligation to update these forward-looking statements.
ITEM 7. EXHIBITS.
Exhibit 10.1 Press Release issued January 10, 2002.
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/ George V. Migausky
---------------------------------------
George V. Migausky
Vice President, Chief Financial Officer
Dated: January 10, 2002