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) November 26, 2001
AMERICAN BIOGENETIC SCIENCES, INC.
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(Exact Name Of Registrant As Specified In Its Charter)
Delaware
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(State or Other Jurisdiction of Incorporation)
0-19041 11-2655906
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(Commission File Number) (I.R.S. Employer Identification No.)
1375 Akron Street, Copiague, New York 11726
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(Address of Principal Executive Offices) (Zip Code)
(631) 789-2600
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(Registrant's Telephone Number, Including Area Code)
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ITEM 5. OTHER EVENTS
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On November 26, 2001, American Biogenetic Sciences, Inc. ("ABS") issued a
press release in connection with its negotiations related to distribution
agreements on vaccines for human and livestock diseases ("human vaccines" and
"livestock vaccines") with manufacturers of such vaccines in the Russian
Federation ("Russia" or "Russian"). ABS has entered into an Exclusive
Distributor Agreement, effective November 30, 2001, with the All-Russian
Research Institute of Veterinary Virology and Microbiology ("Veterinary
Institute"). The agreement grants ABS rights for at least 10 years to act as the
Veterinary Institute's exclusive distributor outside of Russia for certain
biological products related to animals, including livestock vaccines ("livestock
biological products"). The Veterinary Institute owns and manufactures livestock
biological products and is owned and operated by the Russian Academy of
Agricultural Sciences, an organization established by the Russian government.
Under its agreement with the Veterinary Institute, ABS plans to market the
livestock biological products by making them available to pharmaceutical
companies, government agencies and regulatory authorities outside of Russia for
testing and evaluation. The terms of the sale of and specifications related to
livestock biological products will be negotiated from time to time with the
Veterinary Institute. The ability of ABS to sell livestock biological products,
including vaccines, is subject to the results of testing and evaluation and the
approval of government agencies and regulatory authorities in the relevant
country or jurisdiction. ABS further plans that any sales of livestock
biological products will be made through one or more sub-distributors that may
arrange any necessary testing and evaluation. ABS has not signed any agreements
with a sub-distributor. ABS cannot predict if and when it will receive any
revenues from sales of livestock biological products. ABS is responsible for its
own expenses and costs in connection with the Veterinary Institute agreement.
Subsequent to November 26, 2001, ABS learned that the manufacturing
facilities for human vaccines formerly owned and operated by the Russian
Ministry of Health ("Ministry") had been privatized. Therefore, ABS entered into
agreements called Protocols of Understanding and Mutual Support with a
department of the Ministry on December 13, 2001 and with the Ministry at the
Federation level on December 27, 2001, which Protocols obligate the Ministry to
provide the following assistance to ABS: (1) facilitate the establishment of
contracts with one or more manufacturers in Russia of certain human vaccines
that would give ABS the right to market such vaccines outside of Russia; (2)
facilitate the ability of ABS to obtain the licenses and permits that are
necessary in Russia to acquire and export such human vaccines; and (3) monitor
the manufacturing and testing of vaccine production to ensure compliance with
the good manufacturing practices that are adopted in compliance with applicable
Russian regulations.
In conjunction with the Ministry, ABS is undertaking efforts to obtain
agreements with manufacturers of human vaccines in Russia, but ABS has not yet
signed any such agreements. If any such agreements are signed, ABS plans to
market human vaccines by making them available to pharmaceutical companies,
government agencies and regulatory authorities outside of Russia for testing and
evaluation. The ability of ABS to sell human vaccines will be subject to the
results of testing and evaluation and the approval by government agencies and
regulatory authorities in the relevant country or jurisdiction. The terms of the
sale of and specifications related to human vaccines would be negotiated from
time to time with the manufacturers. ABS further plans that any sales of human
vaccines will be made through one or more sub-distributors that may arrange any
necessary testing and evaluation. ABS has not signed any agreements with a
sub-distributor. ABS cannot predict if and when it will receive any revenues
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from the sale of human vaccines. ABS will be responsible for its own expenses
and costs in connection with any such manufacturer's agreement.
In response to its November 26, 2001 announcement, ABS was contacted by
The Nasdaq Stock Market ("Nasdaq") and requested to provide certain additional
factual information with respect to the matters announced. Pending receipt of
that information, Nasdaq halted trading in ABS' common stock at 10:21 a.m. on
November 26. ABS provided Nasdaq with information in response to its request.
ABS decided to voluntarily delist its common stock from quotation on the
Nasdaq SmallCap Market effective at the close of business on January 8, 2002.
Accordingly, the trading halt imposed by Nasdaq on ABS' common stock since
November 26, 2001 is no longer applicable.
ABS intends to have an application for quotation of its common stock filed
with the NASD's OTC Bulletin Board ("OTCBB") by an NASD member firm, as soon as
possible. There can be no assurance that a NASD member firm will file such
application or that ABS' common stock will be accepted for quotation and trading
on the OTCBB or the Pink Sheets or that broker/dealers will be willing to trade
or make a market in the Company's common stock.
The Russian agreements described herein involve certain risks and
uncertainties, including: the results of testing and evaluation of vaccines; the
ability of ABS to obtain necessary government agency and regulatory approvals of
any of the vaccines; the presence of potential negative side-effects and
concerns regarding the efficacy of and lack of experience of regulators with
certain of these human vaccines which may inhibit approval for sale in the
United States or certain other countries; the lack of experience of ABS with
certain of these vaccines; the ability of ABS to consummate necessary agreements
with manufacturers and sub-distributors, and to make sales of the vaccines and
other biological products; the activities of competitors; changes in regulations
applicable to livestock biological products and human vaccines and the
administration of such regulations and other matters.
Copies of the Exclusive Distributor Agreement and the Protocols of
Understanding and Mutual Support are attached as exhibits to this Form 8-K.
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ITEM 7. FINANCIAL STATEMENTS AND EXHIBITS
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(a) FINANCIAL STATEMENTS
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Not applicable.
(b) PRO FORMA FINANCIAL INFORMATION
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Not applicable.
(c) EXHIBITS
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10.1 Exclusive Distributor Agreement
effective as of November 30, 2001
between American Biogenetic Sciences,
Inc. and the All - Russian Research
Institute of Veterinary Virology and
Microbiology
10.2 Protocol of Mutual Understanding and Support dated
December 13, 2001 between the Ministry of Health of
the Russian Federation (the Department) and American
Biogenetic Sciences, Inc.
10.3 Protocol of Mutual Understanding and Support dated
December 27, 2001 between the Ministry of Health of
the Russian Federation and American Biogenetic
Sciences, Inc.
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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, thereunto duly authorized.
AMERICAN BIOGENETIC SCIENCES, INC.
Dated: January 9, 2002
By:_________________________________
Josef C. Schoell
President, Chief Operating Officer and
Chief Financial Officer
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