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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) April 15, 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)
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Item 5. OTHER EVENTS
On April 15, 2002, the U.S. District Court for the District of Maryland
reaffirmed its final order of judgment in IGEN's case against Roche Diagnostics,
a division of F. Hoffmann-La Roche. The judgment, which was entered on February
15, 2002, awards IGEN $505 million in damages; confirms the Company's right to
terminate the license agreement; and directs and commands Roche to grant to IGEN
for use in its retained fields a license to improvements developed by Roche
under the agreement, including Roche's Elecsys(R) diagnostics product line.
In upholding the judgment, the district court rejected several motions
filed by Roche seeking to reduce by more than $400 million the monetary damages
awarded to IGEN. The district court also rejected Roche's challenge to the
jury's finding that Roche materially breached the license agreement in five
separate and distinct ways. Finally, the court dismissed Roche's attempts to
obtain a new trial on numerous issues, including the amount of punitive damages
awarded.
Earlier this year, the Company advised Roche in writing that the
license agreement will automatically terminate once the Court of Appeals affirms
that portion of the judgment holding that Roche materially breached the license
agreement. It is expected that Roche will file an appeal with the Fourth Circuit
Court of Appeals within 30 days. Roche has posted a bond in the amount of $620
million to secure its financial obligations to IGEN under the judgment. The
Company anticipates that the decision of the Court of Appeals will be issued in
mid-2003.
With the judgment now confirmed by the district court, Roche is barred
from marketing, selling, placing or distributing outside of its licensed field
any products, including its Elecsys diagnostics product line, that are based on
IGEN's ORIGEN(R) technology. Once the license agreement is terminated, Roche
will be prohibited from manufacturing, marketing, and selling all ORIGEN-based
products, including its Elecsys diagnostics product line in all markets and to
all customers. Thereafter, IGEN will be free to sell ORIGEN-based products in
all diagnostics markets, including hospitals, blood banks and clinical reference
laboratories. Contrary to a recent letter issued by Roche, Roche will not have
continuing access to the Company's ORIGEN technology or be able to continue
sales or service for its Elecsys product line after the license is terminated.
IGEN has been evaluating various opportunities to exploit its
proprietary ORIGEN technology independently of Roche, both for the field
currently licensed to Roche as well as for IGEN's retained field, such as
physician office laboratories, emergency rooms, intensive care units, among
others. This might include, among other things, commercializing the present
Elecsys product line and integrating these improvements into a new product line.
The Company has been in discussions with third parties regarding the various
possibilities.
With respect to all improvements developed by Roche and its subcontractors
under the license agreement, the judgment commands and directs that within 30
days of the present court ruling, the following must occur:
>> Roche must grant the Company for use in its retained fields an irrevocable,
perpetual, fully-paid (royalty-free), non-exclusive license (with the right
to sublicense) to Roche's entire Elecsys 1010 instrument, entire Elecsys
2010 instrument, all aspects of the ORIGEN-based assays (tests) developed
by Roche, the ORIGEN-based module of the E170 instrument, the ORIGEN-based
DNA probe analyzer developed by Roche, and the nucleic acid amplification
technology called PCR that was used by Roche in connection with the
ORIGEN-based DNA probe system.
>> Roche must deliver to the Company all documents, protocols, formulas,
system specifications, design drawings, processes, data, controls,
materials, regulatory filings, know-how, and show-how in the possession,
custody or control of Roche and all of its subcontractors, including
Hitachi.
>> Roche must deliver to the Company all other information and materials
required or necessary to enable IGEN to design, develop, replicate,
manufacture, validate, obtain regulatory approval for and commercialize the
improvements.
>> Roche must timely respond to all of the Company's reasonable requests for
information and must make its personnel and its subcontractors (including
Hitachi) available to the Company for on-site and other consultations to
ensure the full transfer of the improvements.
>> Roche must bear all costs associated with the transfer to the Company of
the improvements.
This report contains forward-looking statements, within the meaning of the
Private Securities Litigation Reform Act of 1995, about litigation, including
the timing for completion of and prospects for ultimate success on any appeal of
the litigation, the commercial viability of the Company's technology and the
improvements awarded to the Company, the timeline of the transfer of
improvements, the likelihood and affects of a termination of the license to
Roche, the timeline for and likelihood of filing an appeal, the prospects for
new business arrangements, and future growth prospects. Actual results might
differ materially from these statements due to risks and uncertainties,
including risks associated with litigation generally including future decisions
that may be made by the courts. More complete descriptions of the risks
applicable to IGEN appear in the Company's documents filed with the Securities
and Exchange Commission and available on request from the Company. IGEN
disclaims any intent or obligation to update these forward-looking statements.
Signatures
Pursuant to the requirements of the Securities 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 & Chief Executive Officer
Dated: April 17 , 2002