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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) February 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 February 15, 2002 the U.S. District Court for the District of Maryland issued
a Final Order of Judgment in the litigation IGEN International, Inc. v. Roche
Diagnostics, GmbH (Case No. PMJ 97-3461). The Judgment awards the Company $505
million in damages; confirms the Company's right to terminate the Roche license
agreement; and directs and commands Roche to grant to the Company for use in its
retained fields, a license to all improvements developed by Roche under the
agreement, including Roche's Elecsys(R) diagnostics product line.
The Judgment also bars Roche from marketing, selling, placing or distributing
outside of its licensed field any products, including its Elecsys diagnostics
product line, that are based on the Company's ORIGEN(R) technology. The Company
has already notified Roche that the license agreement will be terminated once
the Judgment is affirmed by the Court of Appeals. Once the agreement is
terminated, Roche will be prohibited from commercializing all ORIGEN-based
products, including its Elecsys diagnostics product line, and the Company will
be free to operate, either independently or with new partners, in the field
currently licensed to Roche.
The Company believes that, with this Judgment, it is now able to complete
business arrangements with one or more prospective new partners to fill the
markets currently being served by Roche. Any such agreement would be operative
once the Judgment is upheld. The Company expects that the Judgment will be
upheld on appeal.
With respect to all improvements developed by Roche and its subcontractors under
the license agreement, the Judgment commands and directs that:
>> 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 the Company 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 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
including without limitation, the Company's Annual Report on Form 10-K for the
year ended March 31, 2001, and in the final prospectus dated February 7, 2002,
previously filed with the Securities and Exchange Commission. IGEN disclaims
any intent or obligation to update these forward-looking statements.
ITEM 7 FINANCIAL STATEMENTS AND EXHIBITS
(c) Exhibits
99.1 Final Order of Judgment dated February 15, 2002 issued by
the United States District Court for the District of Maryland in the
case entitled IGEN International, Inc. v. Roche Diagnostics, GmbH (Case
No. PMJ 97-4361).
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/ George Migausky
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George Migausky
Vice President, Chief Financial Officer
Dated: February 20, 2002