As filed with the Securities
and Exchange Commission on January 12, 2004 Registration No. 333-_____
U.S. Securities and Exchange Commission
Washington, D.C. 20549
POST-EFFECTIVE AMENDMENT NO. 1 ON FORM S-3 TO FORM SB-2 ON FORM S-3
REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933
BIOENVISION, INC.
(Name of small business issuer in its charter)
Delaware 2834 13-4025857
-------- ---- ----------
(State or other jurisdiction of (Primary Standard Industrial (I.R.S. Employer
incorporation or organization) Classification Code Number) Identification No.)
509 Madison Avenue
Suite 404
New York, New York 10022
(212) 750-6660
(Address and telephone number of principal
executive offices and principal place of business)
David P. Luci, Esq.
Director of Finance, General Counsel and Corporate Secretary
Bioenvision, Inc.
509 Madison Avenue
Suite 404
New York, New York 10022
(212) 750-6660
(Name, address and telephone
number of agent for service)
Copy to:
Luke P. Iovine, III, Esq.
Paul, Hastings, Janofsky & Walker LLP
75 East 55th Street
New York, NY 10022
(212) 318-6000
Approximate date of commencement of proposed sale to the public: As soon as
practical after the effective date of this Registration Statement. If any of the
securities being registered on this Form are to be offered on a delayed or
continuous basis pursuant to Rule 415 under the Securities Act of 1933, check
the following box. |X|
If this Form is filed to register additional securities for an offering pursuant
to Rule 462(b) under the Securities Act, check the following box and list the
Securities Act registration statement number of the earlier effective
registration statement for the same offering. |_| ___________
If this Form is a post-effective amendment filed pursuant to Rule 462(c) under
the Securities Act, check the following box and list the Securities Act
registration statement number of the earlier effective registration statement
for the same offering. |_| ___________
If this Form is a post-effective amendment filed pursuant to Rule 462(d) under
the Securities Act, check the following box and list the Securities Act
registration number of the earlier registration statement for the same offering.
|_| ___________
If delivery of the prospectus is expected to be made pursuant to Rule 434,
please check the following box. |_|
CALCULATION OF REGISTRATION FEE
Number of Proposed maximum Proposed maximum Amount of
Title of each class of securities to shares to be offering price per aggregate offering registration fee
be registered registered share price ----------------
------------- ---------- ----- -----
Common Stock, par value $.001 per 34,015,739(1) (1) (2) $6,481(2)
share
(1) Represents an aggregate of 34,015,739 shares of Common Stock previously
registered pursuant to Registration Statement on Form SB-2 (Registration No.
333-97443) that are being carried forward in the Prospectus filed with this
Registration Statement.
(2) This amount has previously been paid by the registrant as the registration
fee for the 34,015,739 shares of Common Stock carried forward from the prior
Registration Statement on Form SB-2 (Registration No. 333- 97443).
The registrant hereby amends this Registration Statement on such date or dates
as may be necessary to delay its effective date until the registrant will file a
further amendment which specifically states that this Registration Statement
will thereafter become effective in accordance with Section 8(a) of the
Securities Act of 1933 or until this Registration Statement will become
effective on such date as the Commission, acting pursuant to said Section 8(a),
may determine.
The information in this prospectus is not complete and may be changed. The
selling shareholders may not sell these securities until the registration
statement filed with the Securities and Exchange Commission is effective. This
prospectus is not an offer to sell these securities and it is not soliciting an
offer to buy these securities in any state where such offer or sale is not
permitted.
Subject to completion, January 12, 2004
PROSPECTUS
BIOENVISION, INC.
34,015,739 shares of common stock
Of the shares of stock covered by this prospectus: (i) 10,880,000
shares are issuable upon the conversion of 5,440,000 preferred shares issued in
connection with a private placement consummated in May 2002; (ii) 5,440,000
shares are issuable upon the exercise of warrants issued to preferred
stockholders in connection with a private placement consummated in May 2002;
(iii) 6,650,867 shares were issued to former stockholders of Pathagon Inc. in
February 2002 in connection with the consummation of the acquisition of Pathagon
Inc.; (iv) 1,008,333 shares are issuable upon the exercise of warrants issued to
our financial advisor in connection with a private placement consummated in May
2002; (v) 3,751,995 shares were issued and 3,974,544 shares are issuable upon
the exercise of warrants and options issued to the co-founders, early round
investors and certain former consultants and advisors for services rendered to
or on behalf of us; (vi) 100,000 shares were issued and 200,000 shares are
issuable upon the exercise of warrants issued to a former co-development partner
for services rendered to us; and (vii) 1,500,000 shares are issuable upon the
exercise of warrants issued in connection with a credit facility secured by
Bioenvision in November 2001.
Our common stock is traded on the American Stock Exchange under the
symbol "BIV". The last reported sales price of shares of our common stock on
January 6, 2004 was $4.14 per share.
We urge you to read carefully the "Risk Factors" section beginning on
page 3 where we describe specific risks associated with an investment in
Bioenvision and these securities before you make your investment decision.
Neither the Securities and Exchange Commission nor any state securities
commission has approved or disapproved of these securities or passed upon the
adequacy or accuracy of this prospectus. Any representation to the contrary is a
criminal offense.
The date of this prospectus is January ___, 2004.
TABLE OF CONTENTS
Page
PROSPECTUS SUMMARY............................................................1
THE OFFERING..................................................................2
RISK FACTORS..................................................................3
DISCLOSURE REGARDING FORWARD-LOOKING STATEMENTS...............................11
USE OF PROCEEDS...............................................................11
DESCRIPTION OF SECURITIES.....................................................11
SELLING STOCKHOLDERS..........................................................13
PLAN OF DISTRIBUTION..........................................................17
LEGAL MATTERS.................................................................19
EXPERTS.......................................................................19
WHERE YOU CAN GET MORE INFORMATION............................................19
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PROSPECTUS SUMMARY
You should read the following summary together with the more detailed
information regarding us and the securities being offered for sale by means of
this prospectus and our financial statements and notes to those statements
appearing elsewhere in this prospectus. The summary highlights information
contained elsewhere in this prospectus. The terms "Bioenvision," "the company,"
"we," "our" and "us" refer to Bioenvision, Inc. and its consolidated
subsidiaries unless the context suggests otherwise. The term "you" refers to a
prospective investor.
Bioenvision, Inc.
We are an emerging biopharmaceutical company. Our primary business
focus is the development and distribution of drugs to treat cancer. We have
several products and technologies under development, but our two lead drugs are
Clofarabine and Modrenal(R).
Clofarabine is a purine nucleoside analogue which, based on our own
clinical studies and studies conducted by others on our behalf, we believe is
effective in the treatment of leukemia and lymphoma. Based on Phase I/II
clinical trials performed to date, we also believe Clofarabine may be effective
for the treatment of solid tumors. Clofarabine is currently in Pivotal Phase II
clinical trials for pediatric and adult ALL and AML. In January, 2002, the
European orphan drug application for use of Clofarabine to treat acute leukemia
in adults was approved. Orphan Drug Designation provides the Company with ten
years of market exclusivity in Europe for Clofarabine. The drug has also been
granted orphan drug status and "fast track" treatment by the United States Food
and Drug Administration (the "FDA"). Further, in August 2003, Southern Research
Institute, the inventor of Clofarabine, granted Bioenvision the exclusive,
irrevocable option to sell, market and distribute Clofarabine in Japan and
Southeast Asia. These rights were not previously granted by Southern Research
Institute and fall outside the scope of the Company's then current licensing and
development contracts with respect to Clofarabine. We originally obtained an
exclusive license from Southern Research Institute to sell, market and
distribute Clofarabine throughout the world, except for Japan and Southeast
Asia, for all human applications, pursuant to a co-development agreement, dated
August 31, 1998, between the Company and Southern Research Institute. On March
12, 2001, we granted an option to sell, market and distribute Clofarabine in the
U.S. and Canada to ILEX Oncology, Inc.
Modrenal(R) is an endocrine agent with a novel mode of action that has
demonstrated efficacy against tamoxifin resistant advanced post-menopausal
breast cancer. Modrenal(R) is an ER beta agonist and blocks the kianase mediated
proliferation pathway in breast cancer., which makes it an effective agent in
patients who have acquired endocrine resistence to other hormonal agents. We
launched Modrenal(R) in May 2003 in the United Kingdom, where we have received
regulatory approval for its use in the treatment of post-menopausal breast
cancer. In the first half of 2004, we intend to apply for mutual recognition in
the other four largest European territories in an effort to gain approval for
Modrenal(R) in each such territory. We anticipate receiving approval in each
such territory in the first half of calendar year 2005. Further, we intend to
file an IND for prostate cancer clinical trials in the US and intend to commence
our first US clinical trial in the first quarter of calendar year 2004. Further,
we intend to seek regulatory approval for Modrenal(R) in the United States as
salvage therapy for hormone-sensitive breast cancer upon completion of
additional clinical studies. We originally obtained an exclusive license from
Stegram Pharmaceuticals Ltd. to sell, market and distribute Modrenal(R)
throughout the world, except for Japan and South Africa, for all human and
animal health applications, pursuant to a co-development agreement dated July
15, 1998.
Our primary business strategy is to develop and commercialize our two
lead drugs, Clofarabine and Modrenal(R) for sale in the territories within which
we have licensed the right to sell, market and distribute these drugs. Our
portfolio of compounds also includes four other products and technologies which
have potential market applicability in 12 clinical indications and we anticipate
that revenues derived from Clofarabine and Modrenal(R) will permit us to further
develop these four other products and technologies.
Corporate Background
We were incorporated as Express Finance, Inc. under the laws of the State of
Delaware on August 16, 1996, and changed our name to Ascot Group, Inc. in August
1998 and further to Bioenvision, Inc. in December 1998. Our principal executive
offices are located at 509 Madison Avenue, Suite 404 , New York, New York 10022.
Our telephone number is (212) 750-6700 and our fax number is (212) 750-6777. Our
website is www.bioenvision.com. Information contained on our website does not
constitute, and shall not be deemed to constitute, part of this prospectus.
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The Offering
Shares of common stock offered by the
selling stockholders.......................... 34,015,739
Shares of common stock outstanding as of
January 6, 2004............................... 19,091,535
Shares to be outstanding following
offering (assuming conversion of all
preferred shares into common shares and
exercise of options and warrants, and
assuming no sales of any securities
pursuant to this offering).................... 42,094,412
Use of proceeds............................... We will not receive any proceeds
from the issuance or sale of the
shares included in this offering.
We may receive consideration upon
the exercise of options and we
will receive consideration upon
the conversion of warrants which
we intend to use for general
corporate purposes.
Risk Factors.................................. An investment in our common stock
is subject to significant risks.
You should carefully consider the
information set forth in the
"Risk Factors" section of this
prospectus as well as other
information set forth in this
prospectus, including our
financial statements and related
notes.
Plan of Distribution.......................... The shares of common stock
offered for resale may be sold by
the selling stockholders pursuant
to this prospectus in the manner
described under "Plan of
Distribution" on page 17.
Amex symbol................................... BIV
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RISK FACTORS
You should carefully consider the following risks before you decide to
buy our common stock. Our business, financial condition or operating results may
suffer if any of the events described in the following risk factors actually
occur. There may be additional risks that we are not currently able to identify.
These may also adversely affect our business, financial condition or operating
results. If any of the events we have identified or those that we cannot now
identify occurs, the trading price of our common stock could decline, and you
may lose all or part of the money you paid to buy our common stock.
The price of our common stock is likely to be volatile and subject to wide
fluctuations.
The market price of the securities of biotechnology companies has been,
and can be, especially volatile. Thus, the market price of our common stock is
likely to be subject to wide fluctuations. If our revenues do not grow or grow
more slowly, or, if operating or capital expenditures exceed our expectations
and cannot be adjusted accordingly, or if some other event adversely affects us,
the market price of our common stock could decline. In addition, if the market
for pharmaceutical and biotechnology stocks or the stock market in general
experiences a loss in investor confidence or otherwise fails, the market price
of our common stock could fall for reasons unrelated to our business, results of
operations and financial condition. The market price of our stock also might
decline in reaction to events that affect other companies in our industry even
if these events do not directly affect us or for other reasons.
Certain events could result in a dilution of holders of our common stock.
As of January 6, 2004, we had 19,091,535 shares of common stock
outstanding, 5,440,000 shares of Series A preferred stock outstanding which are
currently convertible into 10,880,000 shares of common stock and 14,469,542
common stock equivalents including warrants and stock options, other than the
options granted under the co-development agreement with ILEX. The exercise and
conversion prices of the common stock equivalents range from $0.735 to $2.00 per
share. These securities also provide for antidilution protection upon the
occurrence of sales of our common stock below certain prices, stock splits,
redemptions, mergers and other similar transactions. If one or more of these
events occurs the number of shares of our common stock that may be acquired upon
conversion or exercise would increase. If converted or exercised, these
securities will result in a dilution to your percentage ownership of our common
stock. The resale of many of the shares of common stock which underlie these
options and warrants are registered under this prospectus and the sale of such
shares may adversely affect the market price of our common stock.
The provisions of Delaware law may inhibit potential acquisition bids that
stockholders may believe are desirable, and the market price of our common stock
may be lower as a result.
We are subject to the anti-takeover provisions of Section 203 of the
Delaware corporate statute, which regulates corporate acquisitions. These
provisions could discourage potential acquisition proposals and could delay or
prevent a change in control transaction. They could also have the effect of
discouraging others from making tender offers for our common stock. As a result,
these provisions may prevent our stock price from increasing substantially in
response to actual or rumored takeover attempts. These provisions may also
prevent changes in our management.
We have a limited operating history, which makes it difficult to evaluate our
business and to predict our future operating results.
Since our inception, we have been primarily engaged in organizational
activities, including developing a strategic operating plan, entering into
various collaborative agreements for the development of products and
technologies, hiring personnel and developing and testing our products. We have
not generated any material revenues to date. Accordingly, we have no relevant
operating history upon which an evaluation of our performance and prospects can
be made.
We have incurred net losses since commencing business and expect future losses.
To date, we have incurred significant net losses, including net losses
of $6,746,326 for the year ended June 30, 2003 and $2,823,015 for the three
months ended September 30, 2003. At September 30, 2003, we had a deficit
accumulated of $31,474,458. We anticipate that we may continue to incur
significant operating losses for the foreseeable future. We may never generate
material revenues or achieve profitability and, if we do achieve profitability,
we may not be able to maintain profitability.
Clinical trials for our products will be expensive and may be time consuming,
and their outcome is uncertain, but we must incur substantial expenses that may
not result in any viable products.
Before obtaining regulatory approval for the commercial sale of a
product, we must demonstrate through pre-clinical testing and clinical trials
that a product candidate is safe and effective for use in humans. Conducting
clinical trials is a lengthy, time-consuming and expensive process. We will
incur substantial expense for, and devote a significant amount of time to
pre-clinical testing and clinical trials.
-3-
Historically, the results from pre-clinical testing and early clinical
trials have often not been predictive of results obtained in later clinical
trials. A number of new drugs have shown promising results in clinical trials,
but subsequently failed to establish sufficient safety and efficacy data to
obtain necessary regulatory approvals. Data obtained from pre-clinical and
clinical activities are susceptible to varying interpretations, which may delay,
limit or prevent regulatory approval. Regulatory delays or rejections may be
encountered as a result of many factors, including changes in regulatory policy
during the period of product development. Regulatory authorities may require
additional clinical trials, which could result in increased costs and
significant development delays.
Completion of clinical trials for any product may take several years or
more. The length of time generally varies substantially according to the type,
complexity, novelty and intended use of the product candidate. Our commencement
and rate of completion of clinical trials may be delayed by many factors,
including:
o inability of vendors to manufacture sufficient quantities of
materials for use in clinical trials;
o slower than expected rate of patient recruitment or
variability in the number and types of patients in a study;
o inability to adequately follow patients after treatment;
o unforeseen safety issues or side effects;
o lack of efficacy during the clinical trials; or
o government or regulatory delays.
If our development agreement with ILEX does not proceed as planned we may incur
delay in the commercialization of Clofarabine, which would delay our ability to
generate sales and cash flow from the sale of Clofarabine.
ILEX has primary responsibility for conducting clinical trials and
administering regulatory compliance and approval matters in the United States
and Canada pursuant to the terms of our co-development agreement with ILEX.
While there are target dates for completion, that agreement allows ILEX time to
continue working beyond those dates under certain circumstances. If ILEX does
not complete clinical trials and regulatory work expeditiously, or if it fails
to do so at all or otherwise fails to meet its obligations under the
co-development agreement, we could lose valuable time in developing Clofarabine
for commercialization. Furthermore, we intend to make use of clinical data from
trials ILEX is conducting to prepare and support our regulatory applications in
Europe and elsewhere. We can not provide assurance that ILEX will not fail to
meet its obligations under the co-development agreement. If this were to occur,
it could have a material adverse effect on our ability to develop Clofarabine,
obtain necessary regulatory approvals, and generate sales and cash flow from the
sale of Clofarabine. If delays in completion constitute a breach by ILEX or
there are certain other breaches of the co-development agreement by ILEX, then,
at our discretion, the primary responsibility for completion would revert to us,
but there is no assurance that we would have the financial, managerial or
technical resources to complete such tasks in timely fashion or at all.
We may fail to address risks we face as a developing business which could
adversely affect the implementation of our business plan.
We are prone to all of the risks inherent to the establishment of any
new business venture. You should consider the likelihood of our future success
to be highly speculative in light of our limited operating history, as well as
the limited resources, problems, expenses, risks and complications frequently
encountered by similarly situated companies. To address these risks, we must,
among other things,
o maintain and increase our product portfolio;
o implement and successfully execute our business and marketing strategy;
o continue to develop new products and upgrade our existing products;
o respond to industry and competitive developments; and
o attract, retain, and motivate qualified personnel.
We may not be successful in addressing these risks. If we are unable to do so,
our business prospects, financial condition and results of operations would be
materially adversely affected.
-4-
We have limited experience in developing products and may be unsuccessful in our
efforts to develop products.
To achieve profitable operations, we, alone or with others, must
successfully develop, clinically test, market and sell our products. The
development of new pharmaceutical products is highly uncertain and subject to a
number of significant risks. Most products resulting from our or our
collaborative partners' product development efforts are not expected to be
available for sale for at least several years, if at all. Potential products
that appear to be promising at early stages of development may not reach the
market for a number of reasons, including:
o discovery during pre-clinical testing or clinical trials that the
products are ineffective or cause harmful side effects;
o failure to receive necessary regulatory approvals;
o inability to manufacture on a large or economically feasible scale;
o failure to achieve market acceptance; or
o preclusion from commercialization by proprietary rights of third
parties.
To date, our resources have been substantially dedicated to the
acquisition, research and development of products and technologies. Most of the
existing and future products and technologies developed by us will require
extensive additional development, including pre-clinical testing and clinical
trials, as well as regulatory approvals, prior to commercialization. Our product
development efforts may not be successful. We may fail to receive required
regulatory approvals from U.S. or foreign authorities for any indication. Any
products, if introduced, may not be capable of being produced in commercial
quantities at reasonable costs or being successfully marketed. The failure of
our research and development activities to result in any commercially viable
products or technologies would materially adversely affect our future prospects.
Our industry is subject to extensive government regulation and our products
require other regulatory approvals which makes it more expensive to operate our
business.
Regulation in General. Virtually all aspects of our business are
regulated by federal and state statutes and governmental agencies in the United
States and other countries. Failure to comply with applicable statutes and
government regulations could have a material adverse effect on our ability to
develop and sell products which would have a negative impact on our cash flow.
The development, testing, manufacturing, processing, quality, safety, efficacy,
packaging, labeling, record-keeping, distribution, storage and advertising of
pharmaceutical products, and disposal of waste products arising from these
activities, are subject to regulation by one or more federal agencies. These
activities are also regulated by similar state and local agencies and equivalent
foreign authorities.
FDA Regulation. All pharmaceutical manufacturers in the United States
are subject to regulation by the FDA under the authority of the Federal Food,
Drug, and Cosmetic Act. Under the Act, the federal government has extensive
administrative and judicial enforcement powers over the activities of
pharmaceutical manufacturers to ensure compliance with FDA regulations. Those
powers include, but are not limited to the authority to:
o initiate court action to seize unapproved or non-complying products;
o enjoin non-complying activities;
o halt manufacturing operations that are not in compliance with current
good manufacturing practices prescribed by the FDA;
o recall products which present a health risk; and
o seek civil monetary and criminal penalties.
Other enforcement activities include refusal to approve product
applications or the withdrawal of previously approved applications. Any
enforcement activities, including the restriction or prohibition on sales of
products marketed by us or the halting of manufacturing operations of us or our
collaborators, would have a material adverse effect on our ability to develop
and sell products which would have a negative impact on our cash flow. In
addition, product recalls may be issued at our discretion or by the FDA or other
domestic and foreign government agencies having regulatory authority for
pharmaceutical product sales. Recalls may occur due to disputed labeling claims,
manufacturing issues, quality defects or other reasons. Recalls of
pharmaceutical products marketed by us may occur in the future. Any product
recall could have a material adverse effect on our revenue and cash flow.
FDA Approval Process. We have a variety of products under development,
including line extensions of existing products, reformulations of existing
products and new products. All "new drugs" must be the subject of an
FDA-approved new drug application before they may be marketed in the United
States. All generic equivalents to previously approved drugs or new dosage forms
of existing drugs must be the subject of an FDA-approved abbreviated new drug
application before they may by marketed in the United
-5-
States. In both cases, the FDA has the authority to determine what testing
procedures are appropriate for a particular product and, in some instances, has
not published or otherwise identified guidelines as to the appropriate
procedures. The FDA has the authority to withdraw existing new drug application
and abbreviated application approvals and to review the regulatory status of
products marketed under the enforcement policy. The FDA may require an approved
new drug application or abbreviated application for any drug product marketed
under the enforcement policy if new information reveals questions about the
drug's safety or effectiveness. All drugs must be manufactured in conformity
with current good manufacturing practices and drugs subject to an approved new
drug application or abbreviated application must be manufactured, processed,
packaged, held and labeled in accordance with information contained in the new
drug application or abbreviated application.
The required product testing and approval process can take a number of
years and require the expenditure of substantial resources. Testing of any
product under development may not result in a commercially-viable product.
Further, we may decide to modify a product in testing, which could materially
extend the test period and increase the development costs of the product in
question. Even after time and expenses, regulatory approval by the FDA may not
be obtained for any products we develop. In addition, delays or rejections may
be encountered based upon changes in FDA policy during the period of product
development and FDA review. Any regulatory approval may impose limitations in
the indicated use for the product. Even if regulatory approval is obtained, a
marketed product, its manufacturer and its manufacturing facilities are subject
to continual review and periodic inspections. Subsequent discovery of previously
unknown problems with a product, manufacturer or facility may result in
restrictions on the product or manufacturer, including withdrawal of the product
from the market.
Foreign Regulatory Approval. Even if required FDA approval has been
obtained with respect to a product, foreign regulatory approval of a product
must also be obtained prior to marketing the product internationally. Foreign
approval procedures vary from country to country and the time required for
approval may delay or prevent marketing. In certain instances, we or our
collaborative partners may seek approval to market and sell some of our products
outside of the United States before submitting an application for approval to
the FDA. The clinical testing requirements and the time required to obtain
foreign regulatory approvals may differ from that required for FDA approval.
Although there is now a centralized European Union approval mechanism for new
pharmaceutical products in place, each European Union country may nonetheless
impose its own procedures and requirements, many of which are time consuming and
expensive, and some European Union countries require price approval as part of
the regulatory process. Thus, there can be substantial delays in obtaining
required approval from both the FDA and foreign regulatory authorities after the
relevant applications are filed.
Changes in Requirements. The regulatory requirements applicable to any
product may be modified in the future. We cannot determine what effect changes
in regulations or statutes or legal interpretations may have on our business in
the future. Changes could require changes to manufacturing methods, expanded or
different labeling, the recall, replacement or discontinuation of certain
products, additional record keeping and expanded documentation of the properties
of certain products and scientific substantiation. Any changes or new
legislation could have a material adverse effect on our ability to develop and
sell products and, therefore, generate revenue and cash flow.
The products under development by us may not meet all of the applicable
regulatory requirements needed to receive regulatory marketing approval. Even
after we expend substantial resources on research, clinical development and the
preparation and processing of regulatory applications, we may not be able to
obtain regulatory approval for any of our products. Moreover, regulatory
approval for marketing a proposed pharmaceutical product in any jurisdiction may
not result in similar approval in other jurisdictions. Our failure to obtain and
maintain regulatory approvals for products under development would have a
material adverse effect on our ability to develop and sell products and,
therefore, generate revenue and cash flow.
We may not be successful in receiving orphan drug status for certain of our
products or, if that status is obtained, fully enjoying the benefits of orphan
drug status.
Under the Orphan Drug Act, the FDA may grant orphan drug designation to
drugs intended to treat a rare disease or condition. A disease or condition that
affects populations of fewer than 200,000 people in the United States generally
constitutes a rare disease or condition. We may not be successful in receiving
orphan drug status for certain of our products. Orphan drug designation must be
requested before submitting a new drug application. After the FDA grants orphan
drug designation, the generic identity of the therapeutic agent and its
potential orphan use are publicized by the FDA. Under current law, orphan drug
status is conferred upon the first company to receive FDA approval to market the
designated drug for the designated indication. Orphan drug status also grants
marketing exclusivity in the United States for a period of seven years following
approval of the new drug application, subject to limitations. Orphan drug
designation does not provide any advantage in, or shorten the duration of, the
FDA regulatory approval process. Although obtaining FDA approval to market a
product with orphan drug status can be advantageous, the scope of protection or
the level of marketing exclusivity that is currently afforded by orphan drug
status and marketing approval may not remain in effect in the future.
Our business strategy involves obtaining orphan drug designation for
certain of the oncology products we have under development. Although Clofarabine
has received orphan drug designation with the FDA and EMEA, we do not know
whether any of
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our other products will receive an orphan drug designation. Orphan drug
designation does not prevent other manufacturers from attempting to develop the
same drug for the designated indication or from obtaining the approval of a new
drug application for their drug prior to the approval of our new drug
application. If another sponsor's new drug application for the same drug and the
same indication is approved first, that sponsor is entitled to exclusive
marketing rights if that sponsor has received orphan drug designation for its
drug. In that case, the FDA would refrain from approving an application by us to
market our competing product for seven years, subject to limitations. Competing
products may not receive orphan drug designations and FDA marketing approval
before the products under development by us.
New drug application approval of a drug with an orphan drug designation
does not prevent the FDA from approving the same drug for a different
indication, or a molecular variation of the same drug for the same indication.
Because doctors are not restricted by the FDA from prescribing an approved drug
for uses not approved by the FDA, it is also possible that another company's
drug could be prescribed for indications for which products developed by us have
received orphan drug designation and new drug application approval. Prescribing
of approved drugs for unapproved uses, commonly referred to as "off label" use,
could adversely affect the marketing potential of products that have received an
orphan drug designation and new drug application approval. In addition, new drug
application approval of a drug with an orphan drug designation does not provide
any marketing exclusivity in foreign markets.
The possible amendment of the Orphan Drug Act by the United States
Congress has been the subject of frequent discussion. Although no significant
changes to the Orphan Drug Act have been made for a number of years, members of
Congress have from time to time proposed legislation that would limit the
application of the Orphan Drug Act. The precise scope of protection that may be
afforded by orphan drug designation and marketing approval may be subject to
change in the future.
The use of our products may be limited or eliminated by professional guidelines
which would decrease our sales of these products and, therefore, our revenue and
cash flows.
In addition to government agencies, private health/science foundations
and organizations involved in various diseases may also publish guidelines or
recommendations to the healthcare and patient communities. These private
organizations may make recommendations that affect the usage of therapies, drugs
or procedures, including products developed by us. These recommendations may
relate to matters such as usage, dosage, route of administration and use of
concomitant therapies. Recommendations or guidelines that are followed by
patients and healthcare providers and that result in, among other things,
decreased use or elimination of products developed by us could have a material
adverse effect on our revenue and cash flows.
Generic products which third parties may develop may render our products
noncompetitive or obsolete.
An increase in competition from generic pharmaceutical products could
have a material adverse effect on our ability to generate revenue and cash flow.
Because many of our competitors have substantially greater capabilities and
resources, they may be able to develop products before us or develop more
effective products or market them more effectively which would limit our ability
to generate revenue and cash flow.
Competition in our industry is intense. Potential competitors in the
United States and Europe are numerous and include pharmaceutical, chemical and
biotechnology companies, most of which have substantially greater capital
resources, marketing experience, research and development staffs and facilities
than us. Although we seek to limit potential sources of competition by
developing products that are eligible for orphan drug designation and new drug
application approval or other forms of protection, our competitors may develop
similar technologies and products more rapidly than us or market them more
effectively. Competing technologies and products may be more effective than any
of those that are being or will be developed by us. The generic drug industry is
intensely competitive and includes large brand name and multi-source
pharmaceutical companies. Because generic drugs do not have patent protection or
any other market exclusivity, our competitors may introduce competing generic
products, which may be sold at lower prices or with more aggressive marketing.
Conversely, as we introduce branded drugs into our product portfolio, we will
face competition from manufacturers of generic drugs which may claim to offer
equivalent therapeutic benefits at a lower price. The aggressive pricing
activities of our generic competitors could have a material adverse effect on
our revenue and cash flow.
If we fail to keep up with rapid technological change and evolving therapies,
our technologies and products could become less competitive or obsolete.
The pharmaceutical industry is characterized by rapid and significant
technological change. We expect that pharmaceutical technology will continue to
develop rapidly, and our future success will depend on our ability to develop
and maintain a competitive position. Technological development by others may
result in products developed by us, branded or generic, becoming obsolete before
they are marketed or before we recover a significant portion of the development
and commercialization expenses incurred with respect to these products.
Alternative therapies or new medical treatments could alter existing treatment
regimes, and thereby reduce the need for one or more of the products developed
by us, which would adversely affect our revenue and cash flow.
-7-
We depend on others for clinical testing of our products which could delay our
ability to develop products.
We do not currently have any internal product testing capabilities. Our
inability to retain third parties for the clinical testing of products on
acceptable terms would adversely affect our ability to develop products. Any
failures by third parties to adequately perform their responsibilities may delay
the submission of products for regulatory approval, impair our ability to
deliver products on a timely basis or otherwise impair our competitive position.
Our dependence on third parties for the development of products may adversely
affect our potential profit margins and our ability to develop and deliver
products on a timely basis.
We depend on others to manufacture our products and have not manufactured them
in significant quantities.
We have never manufactured any products in commercial quantities, and
the products being developed by us may not be suitable for commercial
manufacturing in a cost-effective manner. Manufacturers of products developed by
us will be subject to current good manufacturing practices prescribed by the FDA
or other rules and regulations prescribed by foreign regulatory authorities. We
may not be able to enter into or maintain relationships either domestically or
abroad with manufacturers whose facilities and procedures comply or will
continue to comply with current good manufacturing practices or applicable
foreign requirements. Failure by a manufacturer of our products to comply with
current good manufacturing practices or applicable foreign requirements could
result in significant time delays or our inability to commercialize or continue
to market a product and could have a material adverse effect on our sales of
products and, therefore, our cash flow. In the United States, failure to comply
with current good manufacturing practices or other applicable legal requirements
can lead to federal seizure of violative products, injunctive actions brought by
the federal government, and potential criminal and civil liability on the part
of a company and our officers and employees.
We have limited sales and marketing capability, and may not be successful in
selling or marketing our products.
The creation of infrastructure to commercialize oncology products is a
difficult, expensive and time-consuming process. We may not be able to establish
direct or indirect sales and distribution capabilities or be successful in
gaining market acceptance for proprietary products or for other products. We
currently have very limited sales and marketing capabilities. To market any
products directly, we will need to develop a more fulsome marketing and sales
force with technical expertise and distribution capability or contract with
other pharmaceutical and/or health care companies with distribution systems and
direct sales forces. To the extent that we enter into co-promotion or other
licensing arrangements, any revenues to be received by us will be dependent on
the efforts of third parties. The efforts of third parties may not be
successful. Our failure to establish marketing and distribution capabilities or
to enter into marketing and distribution arrangements with third parties could
have a material adverse effect on our revenue and cash flows.
We depend on patent and proprietary rights to develop and protect our
technologies and products, which rights may not offer us sufficient protection.
The pharmaceutical industry places considerable importance on obtaining
patent and trade secret protection for new technologies, products and processes.
Our success will depend on our ability to obtain and enforce protection for
products that we develop under United States and foreign patent laws and other
intellectual property laws, preserve the confidentiality of our trade secrets
and operate without infringing the proprietary rights of third parties. Through
our current license agreements, we have acquired the right to utilize the
technology covered by issued patents and patent applications, as well as
additional intellectual property and know-how that could be the subject of
further patent applications in the future. Patents may not be issued from these
applications and issued patents may not give us adequate protection. Issued
patents may be challenged, invalidated, infringed or circumvented, and any
rights granted thereunder may not provide us with competitive advantages.
Parties not affiliated with us have obtained or may obtain United States or
foreign patents or possess or may possess proprietary rights relating to
products being developed or to be developed by us. Patents now in existence or
hereafter issued to others may adversely affect the development or
commercialization of products developed or to be developed by us. Our planned
activities may infringe patents owned by others.
We could incur substantial costs in defending infringement suits
brought against us or any of our licensors or in asserting any infringement
claims that we may have against others. We could also incur substantial costs in
connection with any suits relating to matters for which we have agreed to
indemnify our licensors or distributors. An adverse outcome in any litigation
could have a material adverse effect on our ability to sell products or use
patents in the future. In addition, we could be required to obtain licenses
under patents or other proprietary rights of third parties. These licenses may
not be made available on terms acceptable to us, or at all. If we are required
to, and do not obtain any required licenses, we could be prevented from, or
encounter delays in, developing, manufacturing or marketing one or more
products.
We also rely upon trade secret protection for our confidential and
proprietary information. Others may independently develop substantially
equivalent proprietary information and techniques or gain access to our trade
secrets or disclose our technology. We may not be able to meaningfully protect
our trade secrets which could limit our ability to exclusively produce products.
-8-
We require our employees, consultants, members of the scientific
advisory board and parties to collaborative agreements to execute
confidentiality agreements upon the commencement of employment or consulting
relationships or a collaboration with us. These agreements may not provide
meaningful protection of our trade secrets or adequate remedies in the event of
unauthorized use or disclosure of confidential and proprietary information.
If we lose key management or other personnel our business will suffer.
We are highly dependent on the principal members of our scientific and
management staff. We also rely on consultants and advisors, including our
scientific advisors, to assist us in formulating our research and development
strategy. Our success also depends upon retaining key management and technical
personnel, as well as our ability to continue to attract and retain additional
highly-qualified personnel. We face intense competition for personnel from other
companies, government entities and other organizations. We may not be successful
in retaining our current personnel. We may not be successful in hiring or
retaining qualified personnel in the future. If we lose the services of any of
our scientific and management staff or key technical personnel, or if we fail to
continue to attract qualified personnel, our ability to acquire, develop or sell
products would be adversely affected.
Our management and internal systems might be inadequate to handle our potential
growth.
Our success will depend in significant part on the expansion of our
operations and the effective management of growth. This growth will place a
significant strain on our management and information systems and resources and
operational and financial systems and resources. To manage future growth, our
management must continue to improve our operational and financial systems and
expand, train, retain and manage our employee base. Our management may not be
able to manage our growth effectively. If our systems, procedures, controls, and
resources are inadequate to support our operations, our expansion would be
halted and we could lose our opportunity to gain significant market share. Any
inability to manage growth effectively may harm our ability to institute our
business plan.
Because we have international operations, we will be subject to risks of
conducting business in foreign countries.
Because we have international operations in the conduct of our
business, we are subject to the risks of conducting business in foreign
countries, including:
o difficulty in establishing or managing distribution relationships;
o different standards for the development, use, packaging and marketing
of our products and technologies;
o our inability to locate qualified local employees, partners,
distributors and suppliers;
o the potential burden of complying with a variety of foreign laws, trade
standards and regulatory requirements, including the regulation of
pharmaceutical products and treatment; and
o general geopolitical risks, such as political and economic instability,
changes in diplomatic and trade relations, and foreign currency risks.
We will have future capital needs and we may not be able to secure additional
financing which could affect our ability to operate as a going concern.
In May 2002, we completed a $17,750,000 offering through the sale of
shares of Series A preferred stock and common stock purchase warrants. The
common stock purchase warrants are exercisable within five years of the issuance
date. However, we may need additional financing to continue to fund the research
and development of our products and to generally expand and grow our business.
To the extent that we will be required to fund operating losses, our financial
position would deteriorate. There can be no assurance that we will be able to
find significant additional financing at all or on terms favorable to us. If
equity securities are issued in connection with a financing, dilution to our
stockholders may result, and if additional funds are raised through the
incurrence of debt, we may be subject to restrictions on our operations and
finances. Furthermore, if we do incur additional debt, we may be limiting our
ability to repurchase capital stock, engage in mergers, consolidations,
acquisitions and asset sales, or alter our lines of business or accounting
methods, even though these actions would otherwise benefit our business. As of
June 30, 2003, we had stockholders' equity of $18,828,392 and net working
capital of $6,108,493.
If adequate financing is not available, we may be required to delay,
scale back or eliminate some of our research and development programs, to
relinquish rights to certain technologies or products, or to license third
parties to commercialize technologies or products that we would otherwise seek
to develop. Any inability to obtain additional financing, if required, would
have a material adverse effect on our ability to continue our operations and
implement our business plan.
-9-
The prices we charge for our products and the level of third-party reimbursement
may decrease and our revenues could decrease.
Our ability to commercialize products successfully depends in part on
the price we may be able to charge for our products and on the extent to which
reimbursement for the cost of our products and related treatment will be
available from government health administration authorities, private health
insurers and other third-party payors. Government officials and private health
insurers are increasingly challenging the price of medical products and
services. Significant uncertainty exists as to the pricing flexibility
distributors will have with respect to, and the reimbursement status of, newly
approved health care products.
In the United States, for instance, we expect that there will continue
to be a number of federal and state proposals to implement government control of
pricing and profitability of prescription pharmaceuticals. Government imposed
controls could decrease the price we receive for products by preventing the
recovery of development costs and an appropriate profit margin. Any of these
cost controls could have a material adverse effect on our ability to make a
profit. Furthermore, federal and state regulations govern or influence the
reimbursement to health care providers in connection with medical treatment of
certain patients. If any actions are taken by federal and/or state governments,
they could adversely affect the prospects for sales of our products. Actions
taken by federal and/or state governments with regard to health care reform
could have a material adverse effect on our business and our prospects.
Third-party payors may attempt to control costs further by selecting
exclusive providers of their pharmaceutical products. If third-party payors were
to make this type of arrangement with one or more of our competitors, they would
not reimburse patients for purchasing our competing products. This could cause
the acceptance and/or use of our products to decline. This lack of reimbursement
would diminish the market for products developed by us and could have a material
adverse effect on us.
Our products may be subject to recall.
Product recalls may be issued at our discretion or by the FDA, the FTC
or other government agencies having regulatory authority for product sales.
Product recalls, if any in the future, may harm our reputation and cause us to
lose development opportunities, or customers or pay refunds. Products may need
to be recalled due to disputed labeling claims, manufacturing issues, quality
defects, or other reasons. We do not carry any insurance to cover the risk of
potential product recall. Any product recall could have a material adverse
effect on us, our prospects, our financial condition and results of operations.
We may face exposure from product liability claims and product liability
insurance may not be sufficient to cover the costs of our liability claims
related to technologies or products.
We face exposure to product liability claims if the use of our
technologies or products or those we license from third parties is alleged to
have resulted in adverse effects to users thereof. Regulatory approval for
commercial sale of our products does not mitigate product liability risks. Any
precautions we take may not be sufficient to avoid significant product liability
exposure. Although we have obtained product liability insurance on our
technologies and products at levels with which management deems reasonable, no
assurance can be given that this insurance will cover any particular claim or
that we have obtained an appropriate level of liability insurance coverage for
our development and marketing activities. Existing coverage may not be adequate
as we further develop our products. In the future, adequate insurance coverage
or indemnification by collaborative partners may not be available in sufficient
amounts, or at acceptable costs, if at all. To the extent that product liability
insurance, if available, does not cover potential claims, we will be required to
self-insure the risks associated with those claims. The successful assertion of
any uninsured product liability or other claim against us could limit our
ability to sell our products or could cause monetary damages. In addition,
future product labeling may include disclosure of additional adverse effects,
precautions and contra indications, which may adversely impact product sales.
The pharmaceutical industry has experienced increasing difficulty in maintaining
product liability insurance coverage at reasonable levels, and substantial
increases in insurance premium costs in many cases have rendered coverage
economically impractical.
-10-
DISCLOSURE REGARDING FORWARD-LOOKING STATEMENTS
We have made statements under the captions "Risk Factors," and in other
sections of this prospectus that are forward-looking statements. In some cases,
you can identify these statements by forward-looking words such as "may,"
"might," "will," "should," "expects," "plans," "anticipates," "believes,"
"estimates," "predicts," "potential" or "continue," the negative of these terms
and other comparable terminology. These forward-looking statements which are
subject to risks, uncertainties and assumptions about us, may include
projections of our future financial performance, or anticipated growth
strategies and anticipated trends in our business. These statements are only
predictions based on our current expectations and projections about future
events. There are important factors that could cause our actual results, level
of activity, performance or achievements to differ materially from the results,
level of activity, performance or achievements expressed or implied by the
forward-looking statements, including those factors discussed under the section
entitled "Risk Factors." You should specifically consider the numerous risks
outlined under "Risk Factors." Although we believe the expectations reflected in
the forward-looking statements are reasonable, we cannot guarantee future
results, levels of activity, performance or achievements. Moreover, neither we
nor any other person assumes responsibility for the accuracy and completeness or
any of these forward-looking statements.
USE OF PROCEEDS
The selling stockholders will receive the proceeds from the resale of
the shares of common stock. We will not receive any proceeds from the resale of
the shares of common stock by the selling stockholders. We may receive
consideration upon the exercise of options and we will receive consideration
upon the conversion of warrants which we will use for general corporate
purposes.
Expenses we are expected to incur in connection with this registration
are estimated at approximately $150,000. The selling stockholders will pay all
of their underwriting commissions and discounts and counsel fees and expenses in
connection with the resale of the shares covered by this prospectus.
DESCRIPTION OF SECURITIES
Description of Common Stock
Number of Authorized and Outstanding Shares. Our Certificate of
Incorporation authorizes the issuance of 50,000,000 shares of common stock,
$.001 par value per share, of which 19,091,535 shares were outstanding on
January 6, 2003. All of the outstanding shares of common stock are fully paid
and non-assessable.
Voting Rights. Holders of shares of common stock are entitled to one
vote for each share on all matters to be voted on by the stockholders. Holders
of common stock have no cumulative voting rights. Accordingly, the holders of a
simple majority of the outstanding common stock and Series A convertible
preferred stock, voting together as a class at a shareholders meeting at which a
quorum is present, can elect all of the directors nominated for election at the
meeting.
Other. Holders of common stock have no preemptive rights to purchase
our common stock. There are no conversion rights or redemption or sinking fund
provisions with respect to the common stock.
Transfer Agent. Shares of common stock are registered at the transfer
agent and are transferable at such office by the registered holder (or duly
authorized attorney) upon surrender of the common stock certificate, properly
endorsed. No transfer shall be registered unless we are satisfied that such
transfer will not result in a violation of any applicable federal or state
securities laws. The transfer agent for our common stock is Liberty Transfer
Company, 274B New York Avenue, Huntington, New York 11743, Attention: Ms. Lisa
Conger.
Description of Preferred Stock
Number of Authorized Shares. Our certificate of incorporation
authorizes the issuance of up to 10,000,000 shares of preferred stock, par value
$.001 per share, in one or more series with such limitations and restrictions as
may be determined in the sole discretion of our board of directors, with no
further authorization by stockholders required for the creation and issuance
thereof.
We have designated 5,920,000 shares of our preferred stock as Series A
convertible preferred stock, of which 5,440,000 shares were issued and
outstanding as of January 6, 2004. The holders of the Series A convertible
preferred stock vote as a single class with the common stock, on an as-converted
basis, on all matters upon which the holders of the common stock are entitled to
vote. Each outstanding share of Series A convertible preferred stock may
currently be converted into two shares of common stock, at the conversion price
of $1.50 per share. The shares of Series A convertible preferred stock shall be
automatically convertible into
-11-
shares of common stock if the market price of the common stock after one year
from the date of issuance is $10.00 or more for 30 consecutive trading days and
the trading volume is at least 150,000 shares per trading day during such 30-day
period. Holders of Series A convertible preferred stock have a liquidation
preference over holders of common stock of $3.00 per share. Holders of the
Series A convertible preferred stock are entitled to an annual 8% dividend which
may be paid in cash or additional shares of common stock in our sole discretion.
Warrants
As of January 6, 2004, there were outstanding warrants to purchase an
aggregate of 8,899,999 shares of our common stock, exercisable at prices ranging
from $1.25 to $2.33 per share.
Stock Options
As of January 6, 2004, there were outstanding options to purchase an
aggregate of 5,269,544 shares of our common stock, exercisable at prices ranging
from $0.735 to $3.53 per share, of which, options to purchase 4,396,210 shares
were exercisable.
-12-
SELLING STOCKHOLDERS
As discussed elsewhere in this prospectus, the selling shareholders are
individuals or entities who or which either hold shares of our common stock or
may acquire the same upon the conversion of preferred shares or upon the
exercise of certain options or warrants and, as discussed under the caption
"Plan of Distribution" below, may include certain of their pledgees, donees,
transferees or other successors-in-interest who receive shares as a gift,
pledge, partnership distribution or other non-sale related transfer. The
following table sets forth, as of the date of this prospectus:
o the name of each selling shareholder;
o the number of shares of common stock beneficially owned by each
selling shareholder;
o the number of shares of common stock that may be sold in this
offering; and
o the number and percentage of shares of common stock that will be
beneficially owned by each selling shareholder following the
offering to which this prospectus relates.
The information with respect to ownership after the offering assumes
the sale of all of the shares offered and no purchases of additional shares. The
selling shareholders may offer all or part of the shares covered by this
prospectus at any time or from time to time.
For purposes of the table below, the number of shares "beneficially
owned" are those beneficially owned as determined under the rules of the SEC.
Such information is not necessarily indicative of beneficial ownership for any
other purpose. Under such rules, beneficial ownership includes any shares as to
which a person has sole or shared voting power or investment power and any
shares for which the person has the right to acquire such power within 60 days
through the exercise of any option, warrant or right, through conversion of any
security or pursuant to the automatic termination of a power of attorney or
revocation of a trust, discretionary account or similar arrangement. Percentages
in the table below are based on 19,091,535 shares of our common stock
outstanding as of January 6, 2004.
Shares Number of Shares Shares
Owned Prior to Which May be Owned After
the Offering Sold in the Offering
------------ ------- ------------
Name Number Percent This Offering Number Percent
------ ------- ------------- ------ -------
Perseus-Soros 9,000,000 32.60 9,000,000 -- --
BioPharmaceutical Fund, LP (1)
Caduceus Private Investments,
LP(2) 2,009,892 9.75 2,009,892 -- --
OrbiMed Associates LLC (2) 41,835 * 41,835 -- --
PW Juniper Crossover Fund,
L.L.C.(2) 948,273 4.85 948,273 -- --
Special Situations Private
Equity Fund, L.P. (3) 250,000 1.33 250,000 -- --
Xmark Fund, L.P. (4) 144,999 * 144,999 -- --
Xmark Fund, Ltd. (5) 354,999 1.87 354,999 -- --
SDS Merchant Fund, LP (6) 380,001 2.61 380,001 -- --
Orion Biomedical Offshore
Fund, LP (7) 133,875 * 133,875 -- --
Orion Biomedical Fund, LP (8) 616,125 3.20 616,125 -- --
Beaver Ltd. (9) 75,000 * 75,000 -- --
CKH Invest Aps. (10) 50,001 * 50,001 -- --
Merlin Biomed Private Equity
Fund LP (11) 1,000,002 5.10 1,000,002 -- --
Palladin Opportunity Fund LLC(12) 166,666 * 166,666 -- --
DWS Investment GmbH (13) 1,299,999 6.53 1,299,999 -- --
Michael Sistenich (14) 125,001 * 125,001 -- --
Global Biotechnology Fund (15) 199,998 1.06 199,998 -- --
Oklahoma Medical Research
Foundation (16) 300,000 1.39 300,000 -- --
Christopher B. Wood (17) 3,805,258 18.10 3,638,592 -- --
Julie Wood (17) 318,750 1.71 318,750 -- --
Stuart Smith (18) 700,000 3.66 700,000 -- --
Thomas Nelson (19) 287,523 1.06 287,523 -- --
Kevin Leech (20) 1,900,000 9.94 500,000 1,400,000 7.52
Bioaccelerate, Inc. (21) 1,227,272 6.42 500,000 727,272 3.91
Sterling Securities Ltd. (21) 74,045 * 74,045 -- --
Carpe DM, Inc. (21) 59,058 * 59,058 -- --
Michelle Tidball (21) 254,114 1.37 254,114 -- --
Weil Consulting Corporation (21) 75,000 * 75,000 -- --
Kingsley Securities Ltd. (21) 124,544 * 124,544 -- --
Fontenelle LLC (21) 50,000 * 50,000 -- --
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Shares Number of Shares Shares
Owned Prior to Which May be Owned After
the Offering Sold in the Offering
------------ ------- ------------
Name Number Percent This Offering Number Percent
------ ------- ------------- ------ -------
Jano Holdings, Ltd. (22) 250,000 1.33 250,000 -- --
George Margetts (23) 100,000 * 100,000 -- --
Nagy Habib (24) 50,000 * 50,000 -- --
NAB Holdings Ltd. (21) (25) 478,247 2.55 478,247 -- --
SCO Capital Partners LLC (26), (28) 7,009,946 37.67 7,009,946 -- --
SCO Financial Group LLC (26), (28) 100,000 * 100,000 -- --
Daniel DiPietro (30) 50,000 * 50,000 __-- --
Jeremy Kaplan 10,000 * 10,000 -- --
Joshua Golumb 10,000 * 10,000 -- --
The Sophie C. Rouhandeh Trust(26) 150,000 * 150,000 -- --
The Chloe H. Rouhandeh Trust (26) 150,000 * 150,000 -- --
Jeffrey B. Davis (27), (28), (30) 749,243 3.97 749,243 -- --
David Berstein (28) 269,200 1.45 269,200 -- --
Eugene Zurlo (28) 282,900 1.52 282,900 -- --
Robert J. Donohoe (28) 282,400 1.52 282,400 -- --
Al-Midani Investment Company Limited (28) 14,629 * 14,629 -- --
Community Investment Partners (28) 2,560 * 2,560 -- --
Oakwood Investors I, LLC (28) 10,240 * 10,240 -- --
Gutrafin, Ltd. (28) 14,629 * 14,629 -- --
Edward W. Kelly (28), (29) 356,013 1.89 356,013 -- --
Total 36,309,677 34,015,739
* Represents less than 1% of our outst anding shares of common stock.
(1) Includes 3,000,000 shares of Seri es A Preferred Stock currently
convertible into 6,000,000 shares of co mmon stock at a conversion
price of $1.50 and a warrant to purchase 3, 000,000 shares of common
stock exercisable at $2.00 per share for fi ve years from May 8, 2002.
Based upon information contained in it s report on Schedule 13D filed
with the Commission on May 20, 2002, P erseus-Soros BioPharmaceutical
Fund, L.P. reported that Perseus-Sor os BioPharmaceutical Fund, L.P.
and Perseus-Soros Partners may be deemed to have sole power to direct
the voting and disposition of t he 9,000,000 shares of common stock. By
virtue of the relationshi ps between and among Perseus-Soros
BioPharmaceutical Fund, L.P ., Perseus-Soros Partners, LLC, Perseus
BioTech Fund Partners, LLC, SFM Participation, L.P., SFM AH, Inc.,
Frank H. Pearl, George Soros , Soros Fund Management LLC, Perseus EC,
LLC, Perseuspur, LLC, each of such Perseus entities, other than
Perseus-Soros BioPharmaceutical Fund, L.P. and Perseus-Soros Partners,
may be deemed to share the power to direct the voting and disposition
of the 9,000,000 shares of common stock. After the company's May 2002
financing, Perseus-Soros named two individuals to the company's board
of directors.
(2) Includes 669,964 shares of Series A Preferred Stock currently
convertible into 1,339,928 shares of common stock at a conversion price
of $1.50 and a warrant to purchase 669,964 shares of common stock
exercisable at $2.00 per share for five years from May 16, 2002, both
of which are held by Caduceus Private Investments, LP; 13,945 shares of
Series A Preferred Stock currently convertible into 27,980 shares of
common stock at a conversion price of $1.50 and a warrant to purchase
13,945 shares of common stock exercisable at $2.00 per share for five
years from May 16, 2002, both of which are held by OrbiMed Associates
LLC; and 316,091 shares of Series A Preferred Stock currently
convertible into 632,182 shares of common stock at a conversion price
of $1.50 and a warrant to purchase 316,091 shares of common stock
exercisable at $2.00 per share for five years from May 16, 2002, both
of which are held by PW Juniper Crossover Fund, L.L.C. Based upon
information contained in its report on Schedule 13G filed with the
Commission on June 21, 2002, OrbiMed Advisors Inc., OrbiMed Advisors
LLC, OrbiMed Capital LLC and Samuel D. Isaly reported that they share
the power to direct the voting and disposition of the 3,000,000 shares
of common stock.
(3) Warrant to purchase 250,000 shares of common stock exercisable at $2.00
per share for five years from May 8, 2002.
-14-
(4) Includes 48,333 shares of Series A Preferred Stock currently
convertible into 96,666 shares of common stock at a conversion price of
$1.50 and a warrant to purchase 48,333 shares of common stock
exercisable at $2.00 per share for five years from May 8, 2002.
(5) Includes 118,333 shares of Series A Preferred Stock currently
convertible into 236,666 shares of common stock at a conversion price
of $1.50 and a warrant to purchase 118,333 shares of common stock
exercisable at $3.00 per share for five years from May 8, 2002.
(6) Includes 106,667 shares of Series A Preferred Stock currently
convertible into 213,334 shares of common stock at a conversion price
of $1.50 and a warrant to purchase 166,667 shares of common stock
exercisable at $2.00 per share for five years from May 8, 2002.
(7) Includes 44,625 shares of Series A Preferred Stock currently
convertible into 89,250 shares of common stock at a conversion price of
$1.50 and a warrant to purchase 44,625 shares of common stock
exercisable at $2.00 per share for five years from May 8, 2002.
(8) Includes 205,375 shares of Series A Preferred Stock currently
convertible into 410,750 shares of common stock at a conversion price
of $1.50 and a warrant to purchase 205,375 shares of common stock
exercisable at $2.00 per share for five years from May 8, 2002.
(9) Includes 25,000 shares of Series A Preferred Stock currently
convertible into 50,000 shares of common stock at a conversion price of
$1.50 and a warrant to purchase 25,000 shares of common stock
exercisable at $2.00 per share for five years from May 16, 2002.
(10) Includes 16,667 shares of Series A Preferred Stock currently
convertible into 33,334 shares of common stock at a conversion price of
$1.50 and a warrant to purchase 16,667 shares of common stock
exercisable at $2.00 per share for five years from May 14, 2002.
(11) Includes 333,334 shares of Series A Preferred Stock currently
convertible into 666,668 shares of common stock at a conversion price
of $1.50 and a warrant to purchase 333,334 shares of common stock
exercisable at $2.00 per share for five years from May 8, 2002. Based
upon information contained in its report on Schedule 13G filed with the
Commission on June 28, 2002, Merlin BioMed Private Equity Fund, L.P.
reported that it shares the power to direct the voting and disposition
of the 1,000,002 shares of common stock with Merlin BioMed Private
Equity, LLC, its general partner and Dominique Semon, who is the sole
managing member of the general partner.
(12) Includes a warrant to purchase 166,666 shares of common stock
exercisable at $2.00 per share for five years from May 8, 2002.
(13) Includes 433,333 shares of Series A Preferred Stock currently
convertible into 866,666 shares of common stock at a conversion price
of $1.50 and a warrant to purchase 433,333 shares of common stock
exercisable at $2.00 per share for five years from May 14, 2002.
(14) Includes 41,667 shares of Series A Preferred Stock currently
convertible into 83,334 shares of common stock at a conversion price of
$1.50 and a warrant to purchase 41,667 shares of common stock
exercisable at $2.00 per share for five years from May 16, 2002.
(15) Includes 66,666 shares of Series A Preferred Stock currently
convertible into 133,332 shares of common stock at a conversion price
of $1.50 and a warrant to purchase 66,666 shares of common stock
exercisable at $2.00 per share for five years from May 14, 2002.
(16) Under the terms of an amendment to a license agreement with Oklahoma
Medical Research Foundation, we issued 200,000 shares of common stock,
100,000 of which were sold in October 2003, and a five-year warrant to
purchase an additional 200,000 shares of common stock. Such warrant to
purchase 200,000 shares of common stock is exercisable at $2.33 per
share for five years from May 14, 2002.
(17) Dr.Wood is Chairman and Chief Executive Officer of the Company.
Includes 318,750 shares of common stock owned by Julie Wood, Dr. Wood's
spouse, as to which Dr. Wood disclaims any beneficial interest,
1,500,000 options which are exercisable at $1.25 for five years from
April 30, 2001 and 166,666 options which are exercisable at $1.45 per
share from December 31, 2003. Excludes 333,334 options which vest in
equal installments on December 31, 2004 and December 31, 2005.
-15-
(18) Includes options to acquire 500,000 shares of the common stock which
are exercisable at $1.25 per share for five years from April 30, 2001.
(19) Includes options to acquire 200,000 shares of the common stock which
are exercisable at $1.25 per share for five years from April 30, 2001.
(20) These shares are owned of record by Phoenix Ventures Limited, a Channel
Islands (Jersey) corporation, which, to our knowledge, is wholly-owned
by Kevin Leech. These shares include 500,000 options which are
exercisable at $1.25 per share for the benefit of Phoenix.
(21) Bioaccelerate, Inc. is a BVI corporation, owned of record by several
private investors and includes options to acquire 500,000 shares of the
common stock which are exercisable at $1.25 per share for five years
from April 30, 2001. On October 8, 2003, certain options originally
issued to Bioaccelerate, Inc. were transferred as follows:
(i) NAB Holdings Ltd. received options to purchase 500,000 shares of
common stock, 350,000 of which were transferred to Michelle
Tidball on December 9, 2003;
(ii) Sterling Securities Ltd. received options to purchase 100,000
shares of common stock;
(iii) Carpe DM, Inc. received options to purchase 80,000 shares of
common stock;
(iv) Michelle Tidball received options to purchase 100,000 shares of
common stock;
(v) Kingsley Securities Ltd. received options to purchase 124,544
shares of common stock; and
(vi) Fontenelle LLC received options to purchase 50,000 shares of
common stock, which it exercised in November 2003 for 50,000
shares of common stock.
Further, on November 25, 2003, the following recipients of such options
executed a cashless exercise of such options and received the following
shares of the Company's common stock:
(i) Sterling Securities Ltd. received 74,045 shares of common stock;
(ii) Carpe DM, Inc. received 59,058 shares of common stock; and
(iii) Michelle Tidball received 73,811 shares of common stock. On
December 16, 2003, Ms. Tidball executed a cashless exercise of
350,000 options transferred to her by NAB Holdings Inc. and
received 255,303 shares of the Company's common stock, which
includes 75,000 shares issued to Weil Consulting Corporation.
Barbara Platts, in her capacity as Managing Director of Bioaccelerate,
Inc., has investment power and voting power with respect to these
shares, but disclaims any beneficial ownership thereof.
(22) Includes an option to purchase 250,000 shares of common stock
exercisable at $1.25 per share for five years from August 8, 2001.
(23) Includes an option to purchase 100,000 shares of common stock
exercisable at $1.25 per share for five years from April 30, 2001.
(24) Includes an option to purchase 50,000 shares of common stock
exercisable at $1.25 per share for five years from April 30, 2001.
(25) Includes an option to purchase 450,000 shares of common stock
exercisable at $1.25 per share for five years from April 30, 2001. On
December 16, 2003, NAB Holdings Ltd. exercised these options and
received 328,247 shares of common stock pursuant to a cashless
exercise.
(26) Includes a warrant to purchase 100,000 shares of common stock
exercisable at $1.25 per share issued to SCO Financial Group LLC for
five years from November 16, 2001. Excludes a warrant to purchase
70,000 shares of common stock exercisable at $1.50 per share for five
years from May 8, 2002 originally held by SCO Financial Group LLC but
transferred to (i) Daniel DiPietro (50,000); (ii) Jeremy Kaplan
(10,000); and (iii) Joshua Golumb (10,000). SCO Financial Group LLC
serves as financial advisor to the company. SCO Capital Partners LLC
extended a $1 million secured credit line to the company in November
2001. SCO Securities LLC, a related entity, served as placement agent
in the company's May 2002
-16-
private placement of Series A Preferred Stock. After the Pathagon
acquisition, SCO Capital named one individual to the company's board of
directors. After the May 2002 financing, SCO named a second individual
to the company's board of directors.
(27) Includes a warrant to purchase 250,000 shares of common stock
exercisable at $1.50 per share for five years from May 8, 2002. Mr.
Davis is the President of SCO Financial Group LLC, an affiliate of SCO
Capital Partners LLC. Mr. Davis disclaims beneficial ownership of all
shares of common stock deemed beneficially owned by SCO Capital
Partners LLC.
(28) Indicates the selling stockholder was a former stockholder of Pathagon.
(29) Mr. Kelly has executed a consulting agreement with us pursuant to which
we issued to him 200,000 shares of common stock which vested over an
eighteen month period.
(30) Indicates the selling stockholder is a current employee of SCO
Financial Group LLC.
PLAN OF DISTRIBUTION
The shares covered by this prospectus may be offered and sold from time
to time by the selling stockholders. The term "selling stockholders" includes
pledgees, donees, transferees or other successors in interest selling shares
received after the date of this prospectus from the selling stockholders as a
pledge, gift, partnership distribution or other non-sale related transfer. The
number of shares beneficially owned by each selling stockholder will decrease as
and when it effects any such transfers. The plan of distribution for the selling
stockholders' shares sold hereunder will otherwise remain unchanged, except that
the transferees, pledgees, donees or other successors will be selling
stockholders hereunder. To the extent required, we may amend and/or supplement
this prospectus from time to time to describe a specific plan of distribution.
The selling stockholders will act independently of us in making
decisions with respect to the timing, manner and size of each sale. The selling
stockholders may offer their shares from time to time pursuant to one or more of
the following methods:
o on the Amex or on any other market on which our common stock
may from time to time be trading;
o one or more block trades in which the broker or dealer so
engaged will attempt to sell the shares of common stock as
agent but may position and resell a portion of the block as
principal to facilitate the transaction;
o purchases by a broker or dealer as principal and resale by the
broker or dealer for its account pursuant to this prospectus;
o ordinary brokerage transactions and transactions in which the
broker solicits purchasers;
o in public or privately-negotiated transactions;
o through the writing of options on the shares;
through underwriters, brokers or dealers (who may act as agents or
principals) or directly to one or more purchasers;
o an exchange distribution in accordance with the rules of an
exchange;
o through agents;
o through market sales, both long or short, to the extent
permitted under the federal securities laws; or
o in any combination of these methods.
The sale price to the public may be:
o the market price prevailing at the time of sale;
o a price related to the prevailing market price;
o at negotiated prices; or
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o any other prices as the selling stockholder may determine from
time to time.
In connection with distributions of the shares or otherwise, the
selling stockholders may
o enter into hedging transactions with broker-dealers or other
financial institutions, which may in turn engage in short
sales of the shares in the course of hedging the positions
they assume;
o sell the shares short and redeliver the shares to close out
such short positions;
o enter into option or other transactions with broker-dealers or
other financial institutions which require the delivery to
them of shares offered by this prospectus, which they may in
turn resell; and
o pledge shares to a broker-dealer or other financial
institution, which, upon a default, they may in turn resell.
In addition to the foregoing methods, the selling stockholders may
offer their share from time to time in transactions involving principals or
brokers not otherwise contemplated above, in a combination of such methods as
described above or any other lawful methods.
Sales through brokers may be made by any method of trading authorized
by any stock exchange or market on which the shares may be listed or quoted,
including block trading in negotiated transactions. Without limiting the
foregoing, such brokers may act as dealers by purchasing any or all of the
shares covered by this prospectus, either as agents for others or as principals
for their own accounts, and reselling such shares pursuant to this prospectus. A
selling stockholder may effect such transactions directly, or indirectly through
underwriters, broker- dealers or agents acting on their behalf. In effecting
sales, brokers and dealers engaged by the selling stockholders may arrange for
other brokers or dealers to participate.
The shares may also be sold pursuant to Rule 144 under the securities
act, which permits limited resale of shares purchased in a private placement
subject to the satisfaction of certain conditions, including, among other
things, the availability of certain current public information concerning the
issuer, the resale occurring following the required holding period under 144 and
the number of shares during any three-month period not exceeding certain
limitations. The selling stockholders have the sole and absolute discretion not
to accept any purchase offer or make any sale of their shares if they deem the
purchase price to be unsatisfactory at any particular time.
The selling stockholders or their respective pledgees, donees,
transferees or other successors in interest, may also sell the shares directly
to market makers acting as principals and/or broker-dealers acting as agents for
themselves or their customers. These broker-dealers may receive compensation in
the form of discounts, concessions or commissions from the selling stockholders
and/or the purchasers of shares for whom these broker-dealers may act as agents
or to whom they sell as principal or both, which compensation as to a particular
broker-dealer might be in excess of customary commissions. Market makers and
block purchasers purchasing the shares will do so for their own account and at
their own risk. It is possible that the selling stockholders will attempt to
sell shares of common stock in block transactions to market makers or other
purchasers at a price per share which may be below the then market price. The
selling stockholders cannot assure that all or any of the shares offered by this
prospectus will be issued to, or sold by, the selling stockholders if they do
not exercise or convert the common stock equivalents that they own. The selling
stockholders and any brokers, dealers or agents, upon effecting the sale of any
of the shares offered by this prospectus, may be deemed "underwriters" as that
term is defined under the securities act or the exchange act, or the rules and
regulations under those acts. In that event, any commissions received by the
broker-dealers or agents and any profit on the resale of the shares of common
stock purchased by them may be deemed to be underwriting commissions or
discounts under the securities act.
The selling stockholders, alternatively, may sell all or any part of
the shares offered by this prospectus through an underwriter. To our knowledge,
none of the selling stockholders have entered into any agreement with a
prospective underwriter and there can be no assurance that any such agreement
will be entered into. If the selling stockholders enter into such an agreement
or agreements, then we will set forth in a post-effective amendment to this
prospectus the following information:
o the number of shares being offered;
o the terms of the offering, including the name of any selling
stockholder, underwriter, broker, dealer or agent;
o the purchase price paid by any underwriter;
o any discount, commission and other underwriter compensation;
o any discount, commission or concession allowed or reallowed or
paid to any dealer;
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o the proposed selling price to the public; and
o other facts material to the transaction.
We will also file such agreement or agreements. In addition, if we are
notified by the selling stockholders that a donee, pledgee, transferee or other
successor-in-interest intends to sell more than 500 shares, a supplement to this
prospectus will be filed.
The selling stockholders and any other persons participating in the
sale or distribution of the shares will be subject to applicable provisions of
the exchange act and the rules and regulations under the exchange act,
including, without limitation, Regulation M. These provisions may restrict
certain activities of, and limit the timing of purchases and sales of any of the
shares by, the selling stockholders or any other such person. Furthermore, under
Regulation M, persons engaged in a distribution of securities are prohibited
from simultaneously engaging in market making and certain other activities with
respect to the same securities for a specified period of time prior to the
commencement of the distribution, subject to specified exceptions or exemptions.
All of these limitations may affect the marketability of the shares.
We have agreed to pay all costs and expenses incurred in connection
with the registration of the shares offered by this prospectus, except that the
selling stockholder will be responsible for all selling commissions, transfer
taxes and related charges in connection with the offer and sale of the shares
and the fees of the selling stockholder's counsel.
We have agreed with the selling stockholders to keep the registration
statement of which this prospectus forms a part continuously effective until the
earlier of the date that the shares covered by this prospectus may be sold
pursuant to Rule 144(k) of the securities act and the date that all of the
shares registered for sale under this prospectus have been sold.
We have agreed to indemnify the selling stockholders, or their
respective transferees or assignees, against certain liabilities, including
liabilities under the securities act, or to contribute to payments that the
selling stockholders or their respective pledgees, donees, transferees or other
successors in interest, may be required to make in respect of those liabilities.
LEGAL MATTERS
The validity of the shares of common stock offered by this prospectus
and other legal matters relating to this offering will be passed on by Paul,
Hastings, Janofsky & Walker LLP, New York, New York.
EXPERTS
Our auditors are Grant Thornton LLP. Our consolidated financial
statements as at and for the year ended June 30, 2003 and June 30, 2002 included
in our annual report on Form 10-KSB for the year ended June 30, 2003 and
incorporated by reference herein, have been incorporated by reference herein in
reliance upon the report of Grant Thornton LLP, independent accountants, given
on the authority of said firm as experts in accounting and auditing.
WHERE YOU CAN GET MORE INFORMATION
We file annual, quarterly and special reports, proxy statements and
other information with the SEC. You may read and copy any materials we have
filed with the SEC at the SEC's public reference rooms. The SEC also maintains a
web site (http://www.sec.gov) that contains reports, proxy statements and other
information concerning us. Please call the SEC at 1-800-SEC-0330 for information
concerning the operations of the public reference rooms or visit the SEC at the
following locations:
Public Reference Room Midwest Regional Office
450 Fifth Street Citicorp Center
Room 1024 500 West Madison Street
Washington, D.C. 20549 Suite 1400
Chicago, Illinois 60661-2511
We have filed with the SEC a registration statement on Form S-3 under
the Securities Act to register the securities to be sold in this offering. This
prospectus, which is part of the registration statement, does not contain all of
the information set forth in the registration statement or the exhibits and
schedules to the registration statement. For further information regarding
Bioenvision and our securities, please refer to the registration statement and
the documents filed as exhibits to the registration statement.
-19-
The SEC allows us to "incorporate by reference" the information we file
with it, which means that we can disclose important information to you by
referring you to those filed documents. The information incorporated by
reference is considered to be part of this prospectus, and information that we
file later with the SEC will automatically update and supersede this
information.
The following documents, which have been filed with the SEC, are hereby
incorporated by reference:
o Our definitive proxy statement on Schedule 14A filed on December 15,
2003 (File No. 001-31787);
o Our quarterly report on Form 10-QSB for the fiscal quarter ended
September 30, 2003 filed on November 14, 2003 (File No. 001-31787);
o Our annual report on Form 10-KSB for the year ended June 30, 2003 filed
on September 29, 2003 (File No. 001-31787);
All other reports and documents subsequently filed by us with the SEC
pursuant to Sections 13(a), 13(c), 14 or 15(d) of the Securities Exchange Act
after the date of this prospectus and prior to the termination of the offering
are deemed incorporated by reference into this prospectus and a part hereof from
the date of filing of those documents. Any statement contained in any document
incorporated by reference shall be deemed to be modified or superseded for the
purposes of this prospectus to the extent that a statement contained in a later
document modifies or supersedes such statement. Any statements so modified or
superseded shall not be deemed to constitute a part of this prospectus, except
as modified or superseded.
We will provide without charge to each person to whom this prospectus
is delivered, upon written or oral request of such person, a copy of any or all
of the documents referred to above which have been or may be incorporated by
reference into this prospectus (other than the exhibits to such documents).
Requests for such documents should be directed to Bioenvision Inc., 509 Madison
Avenue, Suite 404, New York, New York 10022, Attention: David P. Luci
(telephone: (212) 750-6660).
We have not authorized any dealer, salesperson or other person to give
any information or represent anything not contained in this prospectus. You
should not rely on any unauthorized information. This prospectus does not offer
to sell or solicit an offer to buy any shares in any jurisdiction in which it is
unlawful. The information in this prospectus is current as of the date on the
cover.
-20-
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 14. Other Expenses of Issuance and Distribution. The following sets forth
the estimated expenses payable in connection with the preparation and filing of
this Registration:
*Printing and Engraving Expenses.......................... 15,000
*Accounting Fees and Expenses............................. 18,000
*Legal Fees and Expenses.................................. 100,000
*Blue Sky Fees and Expenses............................... 2,000
*Transfer Agent's and Registrar's Fees and Expenses....... 1,000
*Miscellaneous............................................ 14,000
-----
*Total......................................... $150,000
====== ========
* Estimated.
Item 15. Indemnification of Directors and Officers.
The indemnification of officers and directors of the Registrant is governed by
Section 145 of the General Corporation Law of the State of Delaware (the "DGCL")
and the Certificate of Incorporation, as amended, and By-Laws of the Registrant.
Subsection (a) of DGCL Section 145 empowers a corporation to indemnify any
person who was or is a party or is threatened to be made a party to any
threatened, pending or completed action, suit or proceeding, whether civil,
criminal, administrative or investigative (other than an action by or in the
right of the corporation) by reason of the fact that the person is or was a
director, officer, employee or agent of the corporation, or is or was serving at
the request of the corporation as a director, officer, employee or agent of
another corporation, partnership, joint venture, trust or other enterprise,
against expenses (including attorneys' fees), judgments, fines and amounts paid
in settlement actually and reasonably incurred by the person in connection with
such action, suit or proceeding if the person acted in good faith and in the
manner the person reasonably believed to be in or not opposed to the best
interests of the corporation, and, with respect to any criminal action or
proceeding, had no reasonable cause to believe the person's conduct was
unlawful.
Subsection (b) of DGCL Section 145 empowers a corporation to indemnify any
person who was or is a party or is threatened to be made a party to any
threatened, pending or completed action or suit by or in the right of the
corporation to procure a judgment in its favor by reason of the fact that the
person is or was a director, officer, employee or agent of the corporation, or
is or was serving at the request of the corporation as a director, officer,
employee or agent of another corporation, partnership, joint venture, trust or
other enterprise against expenses (including attorneys' fees) actually and
reasonably incurred by the person in a connection with the defense or settlement
of such action or suit if the person acted in good faith and in the manner the
person reasonably believed to be in or not opposed to the best interests of the
corporation and except that no indemnification shall be made in respect of any
claim, issue or matter as to which such person shall have been adjudged to be
liable to the corporation unless and only to the extent that the Delaware Court
of Chancery or the court in which such action or suit was brought shall
determine upon application that, despite the adjudication of liability but in
view of all the circumstances of the case, such person is fairly and reasonably
entitled to indemnity for such expenses which the Court of Chancery or such
other court shall deem proper.
DGCL Section 145 further provides that to the extent that to a present or former
director or officer is successful, on the merits or otherwise, in the defense of
any action, suit or proceeding referred to in subsections (a) and (b) of Section
145, or in defense of any claim, issue or matter therein, such person shall be
indemnified against expenses (including attorneys' fees) actually and reasonably
incurred by such person in connection therewith. In all cases in which
indemnification is permitted under subsection (a) and (b) of Section 145 (unless
ordered by a court), it shall be made by the corporation only as authorized in
the specific case upon a determination that indemnification of the present or
former director, officer, employee or agent is proper in the circumstances
because the applicable standard of conduct has been met by the party to be
indemnified. Such determination must be made, with respect to a person who is a
director or officer at the time of such determination, (1) by a majority vote of
the directors who are no parties to such action, suit or proceeding, even though
less than a quorum, or (2) by a committee of such directors designated by
majority vote of such directors, even though less than a quorum, or (3) if there
are no such directors, or if such directors so direct, by independent legal
counsel in a written opinion, or (4) by the stockholders. The statute authorizes
the corporation to pay expenses incurred by an officer or director in advance of
the final disposition of a proceeding upon receipt of an undertaking by or on
behalf of the person to whom the advance will be made, to repay the advances if
it shall ultimately be determined that he was not entitled to indemnification.
DGCL Section 145 also provides that indemnification and advancement of expenses
permitted thereunder are not to be exclusive of any other rights to which those
seeking indemnification or advancement of expenses may be entitled under any
By-law, agreement, vote of stockholders or disinterested directors, or
otherwise. DGCL Section 145 also authorizes the corporation to purchase and
maintain
II-1
liability insurance on behalf of its directors, officers, employees and agents
regardless of whether the corporation would have the statutory power to
indemnify such persons against the liabilities insures.
Article Seventh of the Certificate of Incorporation of the Registrant, as
amended (the "Certificate"), provides that no director of the Registrant shall
be personally liable to the Registrant or its stockholders for monetary damages
for breach of fiduciary duty as a director except for liability (i) for any
breach of the director's duty of loyalty to the Registrant or its stockholders,
(ii) for acts or omissions not in good faith or which involve intentional
misconduct or a knowing violation of law, (iii) under Section 174 of the DGCL
(involving certain unlawful dividends or stock purchases or redemptions), or
(iv) for any transaction from which the director derived an improper personal
benefit.
Pursuant to Section 145(g) of the DGCL, the Registrant's By-Laws, as amended,
authorize the Registrant to obtain insurance to protect officers and directors
from certain liabilities, including liabilities against which the Registration
cannot indemnify its officers and directors.
In derivative actions, Bioenvision may only protect from liability its officers,
directors, employees and agents against expenses actually and reasonably
incurred in connection with the defense or settlement of a suit, and only if
they acted in good faith and in a manner they reasonably believed to be in, or
not opposed to, the best interests of the corporation. Indemnification is not
permitted in the event that the director, officer, employee or agent is actually
adjudged liable to Bioenvision unless, and only to the extent that, the court in
which the action was brought so determines.
Bioenvision's Certificate of Incorporation permits it to protect from liability
its directors except in the event of: (1) any breach of the director's duty of
loyalty to Bioenvision or its stockholders; (2) any act or failure to act that
is not in good faith or involves intentional misconduct or a knowing violation
of the law; (3) liability arising under Section 174 of the Delaware General
Corporation Law, relating to unlawful stock purchases, redemptions, or payment
of dividends; or (4) any transaction in which the director received an improper
personal benefit.
Item 16. Exhibits
Exhibit
Number Description
------- -------
2.1 Acquisition Agreement between Registrant and
Bioenvision, Inc. dated December 21, 1998 for the
acquisition of 7,013,897 shares of Registrant's Common
Stock by the stockholders of Bioenvision, Inc. (1)
2.2 Amended and Restated Agreement and Plan of Merger,
dated as of February 1, 2002, by and among Bioenvision,
Inc., Bioenvision Acquisition Corp. and Pathagon, Inc.
(5)
3.1 Certificate of Incorporation of Registrant. (2)
3.1(a) Amendment to Certificate of Incorporation filed January
29, 1999. (3)
3.1(b) Certificate of Correction to the Certificate of
Incorporation, filed March 15, 2002 (6)
3.1(c) Certificate of Amendment to the Certificate of
Incorporation, filed April 30, 2002 (6)
3.2 Amended and Restated By-Laws of the Registrant. (13)
3.2(a) Amendment to Bylaws, effective April 30, 2002 (6)
4.1 Certificate of Designation (6)
4.2 Form of Warrant (6)
4.3 Registration Rights Agreement, dated April 2, 2003, by
and between Bioenvision, Inc. and RRD International,
LLC (14)
4.4 Warrant, dated April 2, 2003, made by Bioenvision, Inc.
in favor of RRD International, LLC (14)
II-2
5.1* Opinion of Paul, Hastings, Janofsky & Walker, LLP
10.1 Pharmaceutical Development Agreement, dated as of June
10, 2003, by and between Bioenvision, Inc. and Ferro
Pfanstiehl Laboratories, Inc. (15)
10.2 Co-Development Agreement between Bioheal, Ltd. and
Christopher Wood dated May 19, 1998. (3)
10.3 Master Services Agreement, dated May 14, 2003, by and
between PennDevelopment Pharmaceutical Services Limited
and Bioenvision, Inc. (15)
10.4 Co-Development Agreement between Stegram
Pharmaceuticals, Ltd. And Bioenvision, Inc. dated July
15, 1998. (3)
10.5 Co-Development Agreement between Southern Research
Institute and Eurobiotech Group, Inc. dated August 31,
1998. (3)
10.5(a) Agreement to Grant License from Southern Research
Institute to Eurobiotech Group, Inc. dated September 1,
1998. (3)
10.6 License and Sub-License Agreement, dated as of May 13,
2003, by and between Bioenvision, Inc. and Dechra
Pharmaceuticals, plc (15)
10.7 Employment Agreement between Bioenvision, Inc. and
Christopher B. Wood, M.D., dated December 31, 2002 (3)
10.8 Employment Agreement between Bioenvision, Inc. and
David P. Luci, dated March 31, 2003. (14)
10.9 Securities Purchase Agreement with Bioaccelerate Inc
dated March 24, 2000. (4)
10.10 Engagement Letter Agreement, dated as of November 16,
2001, by and between Bioenvision, Inc. and SCO
Securities LLC. (7)
10.11 Security Agreement, dated as of November 16, 2001, by
Bioenvision, Inc. in favor of SCO Capital Partners LLC.
(7)
10.12 Commitment Letter, dated November 16, 2001, by and
between SCO Capital Partners LLC and Bioenvision, Inc.
(7)
10.13 Senior Secured Grid Note, dated November 16, 2001, by
Bioenvision, Inc. in favor of SCO Capital Partners LLC.
(7)
10.14 Registration Rights Agreement, dated as of February 1,
2002, by and among Bioenvision, Inc., the former
shareholders of Pathagon, Inc. party thereto,
Christopher Wood, Bioaccelerate Limited, Jano Holdings
Limited and Lifescience Ventures Limited. (8)
10.15 Stockholders Lock-Up Agreement, dated as of February 1,
2002, by and among Bioenvision, Inc., the former
shareholders of Pathagon, Inc. party thereto,
Christopher Wood, Bioaccelerate Limited, Jano Holdings
Limited and Lifescience Ventures Limited. (8)
10.16 Form of Securities Purchase Agreement by and among
Bioenvision, Inc. and certain purchasers, dated as of
May 7, 2002. (6)
10.17 Form of Registration Rights Agreement by and among
Bioenvision, Inc. and certain purchasers, dated as of
May 7, 2002. (6)
10.18 Exclusive License Agreement by and between Baxter
Healthcare Corporation, acting through its Edwards
Critical-Care division, and Implemed, dated as of May
6, 1997. (12)
II-3
10.19 License Agreement by and between Oklahoma Medical
Research Foundation and bridge Therapeutic Products,
Inc., dated as of January 1, 1998. (12)
10.20 Amendment No. 1 to License Agreement by and among
Oklahoma Medical Research Foundation, Bioenvision, Inc.
and Pathagon, Inc., dated May 7, 2002. (12)
10.21 Inter-Institutional Agreement between Sloan-Kettering
Institute for Cancer Research and Southern Research
Institute, dated as of August 31, 1998. (12)
10.22 License Agreement between University College London and
Bioenvision, Inc., dated March 1, 1999. (12)
10.23 Research Agreement between Stegram Pharmaceuticals
Ltd., Queen Mary and Westfield College and Bioenvision,
Inc., dated June 8, 1999 (12)
10.24 Research and License Agreement between Bioenvision,
Inc., Velindre NHS Trust and University College Cardiff
Consultants, dated as of January 9, 2001. (12)
10.25 Co-Development Agreement, between Bioenvision, Inc. and
ILEX Oncology, Inc., dated March 9, 2001. (12)
10.26 Amended and Restated Agreement and Plan of Merger,
dated as of February 1, 2002, among Bioenvision, Inc.,
Bioenvision Acquisition Corp. and Pathagon Inc. (5)
10.27 Master Services Agreement, dated as of April 2, 2003,
by and between Bioenvision, Inc. and RRD International,
LLC(14)
16.1 Letter from Graf Repetti & Co., LLP to the Securities
and Exchange Commission, dated September 30, 1999. (9)
16.2 Letter from Ernst & Young LLP to the Securities and
Exchange Commission, dated July 6, 2001. (10)
16.3 Letter from Ernst & Young LLP to the Securities and
Exchange Commission, dated August 16, 2001. (11)
21.1 Subsidiaries of the registrant (4)
23.1 Consent of Grant Thornton LLP
23.2* Consent of Paul, Hastings, Janofsky & Walker LLP
(included in Exhibit 5.1)
24.1 Power of Attorney (appears on signature page)
* To be filed by amendment.
-----------------------
(1) Incorporated by reference and filed as an Exhibit to Registrant's Current
Report on Form 8-K filed with the SEC on January 12, 1999.
(2) Incorporated by reference and filed as an Exhibit to Registrant's
Registration Statement on Form 10-12g filed with the SEC on September 3,
1998.
(3) Incorporated by reference and filed as an Exhibit to Registrant's Form
10-KSB/A filed with the SEC on October 18, 1999.
(4) Incorporated by reference and filed as an Exhibit to Registrant's Form
10-KSB filed with the SEC on November 13, 2000.
(5) Incorporated by reference and filed as an Exhibit to Registrant's Current
Report on Form 8-K filed with the SEC on April 16, 2002.
(6) Incorporated by reference and filed as an Exhibit to Registrant's Current
Report on Form 8-K, filed with the SEC on May 28, 2002.
II-4
(7) Incorporated by reference and filed as an Exhibit to Registrant's Current
Report on Form 8-K, filed with the SEC on January 8, 2002.
(8) Incorporated by reference and filed as an Exhibit to Registrant's Current
Report on Form 8-K, filed with the SEC on February 21, 2002.
(9) Incorporated by reference and filed as an Exhibit to Registrant's Current
Report on Form 8-K, filed with the SEC on October 1, 1999.
(10) Incorporated by reference and filed as an Exhibit to Registrant's Current
Report on Form 8-K/A, filed with the SEC on July 26, 2001.
(11) Incorporated by reference and filed as an Exhibit to Registrant's Current
Report on Form 8-K, filed with the SEC on December 6, 2001.
(12) Incorporated by reference and filed as an Exhibit to Registrant's Current
Report on Form 8-K, filed with the SEC on June 24, 2002.
(13) Incorporated by reference and filed as an Exhibit to Registrant's
Quarterly Report on Form 10-QSB for the three-month period ended December
31, 2002.
(14) Incorporated by reference and filed as an Exhibit to Registrant's
Quarterly Report on Form 10-QSB for the three-month period ended March
31, 2003.
(15) Incorporated by reference and filed as an Exhibit to Registrant's Form
10-KSB filed with the SEC on September 29, 2003.
Item 17. Undertakings.
(a) The undersigned registrant hereby undertakes:
(1) To file, during any period in which offers or sales
are being made, a post-effective amendment to this
registration statement:
(i) To include any prospectus required by section
10(a)(3) of the Securities Act of 1933, as amended.
(ii) To reflect in the prospectus any facts or
events arising after the effective date of the
registration statement (or the most recent
post-effective amendment thereof) which, individually
or in the aggregate, represent a fundamental change in
the information set forth in the registration
statement. Notwithstanding the foregoing, any increase
or decrease in volume of securities offered (if the
total dollar value of securities offered would not
exceed that which was registered) and any deviation
from the low or high end of the estimated maximum
offering range may be reflected in the form of
prospectus filed with the Securities and Exchange
Commission pursuant to Rule 424(b), if, in the
aggregate, the changes in volume and price represent
not more than a 20% change in the maximum aggregate
offering price set forth in the "Calculation of
Registration Fee" table in the effective registration
statement.
(iii) To include any material information with
respect to the plan of distribution not previously
disclosed in the registration statement or any
material change to such information in the
registration statement.
Provided, however, that paragraphs (a)(1)(i) and
(a)(1)(ii) do not apply if the registration
statement is on Form S-3, Form S-8, or Form F-3,
and the information required to be included in a
post-effective amendment by those paragraphs is
contained in periodic reports filed by the
registrant pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934 that are
incorporated by reference in the registration
statement.
(2) That, for the purpose of determining any
liability under the Securities Act of 1933, each
such post-effective amendment shall be deemed to
be a new registration statement relating to the
securities offered therein, and the offering of
such securities at that time shall be deemed to
be the initial bona fide offering thereof.
II-5
(3) To remove from registration by means of a
post-effective amendment any of the securities
being registered which remain unsold at the
termination of this offering.
(b) The undersigned registrant hereby undertakes that, for
purposes of determining any liability under the Securities Act
of 1933, each filing of the registrant's annual report
pursuant to Section 13(a) or Section 15(d) of the Securities
Exchange Act of 1934 (and, where applicable, each filing of an
employee benefit plan's annual report pursuant to Section
15(d) of the Securities Exchange Act of 1934) that is
incorporated by reference in the registration statement shall
be deemed to be a new registration statement relating to the
securities offered therein, and the offering of such
securities at that time shall be deemed to be the initial bona
fide offering thereof.
(c) Insofar as indemnification for liabilities arising under the
Securities Act of 1933 may be permitted to directors, officers
or persons controlling the registrant pursuant to the
foregoing provisions, the registrant has been advised that in
the opinion of the Securities and Exchange Commission such
indemnification is against such public policy as expressed in
the Act and is, therefore, unenforceable. In the event that a
claim for indemnification against such liabilities (other than
the payment by the registrant of expanses incurred or paid by
a director, officer or controlling person of the registrant in
the successful defense if any action, suit or proceeding) is
asserted by such director, officer or controlling person in
connection with the securities being registered, the
registrant will, unless in the opinion of its counsel the
matter has been settled by controlling precedent, submit to a
court of appropriate jurisdiction the question whether such
indemnification by it is against public policy as expressed in
the Act and will be governed by the final adjudication of such
issue.
II-6
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the Registrant
certifies that it has reasonable grounds to believe that it meets all of the
requirements for filing on Form S-3 and authorized this Registration Statement
to be signed on its behalf by the undersigned, thereunto duly authorized, in the
City of New York, State of New York, on the 12th day of January, 2004.
BIOENVISION, INC.
By /s/ Christopher B. Wood
--------------------------
Christopher B. Wood, Chairman of the
Board and Chief Executive Officer
KNOW ALL MEN BY THESE PRESENT, that each person whose signature appears below
constitutes and appoints Christopher B. Wood as his/her true and lawful
attorney-in-fact and agent, with full power of substitution and resubstitution
for him/her and in his/her name, place and stead, in any and all capacities, to
sign any and all amendments and post-effective amendments to this registration
statement, and make such changes and additions to this registration statement
for the same offering that may be filed under Rule 462(b), and to file the same,
with all exhibits thereto, and other documents in connection therewith, with the
Securities and Exchange Commission, granting unto the attorney-in-fact and agent
full power and authority to do and perform each and every act and thing
requisite and necessary to be done and about the premises, as fully to all
intents and purposes as he/she might or could do in person, thereby ratifying
and confirming all that the attorney-in-fact and agent, or his/her substitutes,
may lawfully do or cause to be done by virtue thereof and the registrant hereby
confers like authority on its behalf.
In accordance with the requirements of the Securities Act of 1933, this
registration statement has been signed by the following persons in the
capacities and on the dates indicated.
Signature Title Date
--------- ----- ----
/s/ Christopher B. Wood, M.D. Chairman and Chief Executive Officer and January 12, 2004
----------------------------- Director
Christopher B. Wood, M.D. (Principal Executive Officer)
/s/ David P. Luci Director of Finance, General Counsel and
----------------- Corporate Secretary January 12, 2004
David P. Luci (Principal Accounting Officer)
/s/ Thomas S. Nelson, C.A. Director January 12, 2004
--------------------------
Thomas S. Nelson, C.A.
/s/ Jeffrey B. Davis Director January 12, 2004
--------------------
Jeffrey B. Davis
/s/ Andrew N. Schiff
--------------------
Andrew N. Schiff Director January 12, 2004
/s/ Steven A. Elms Director January 12, 2004
------------------
Steven A. Elms
II-7
EXHIBIT INDEX
Exhibit
Number Description
------- -------
2.1 Acquisition Agreement between Registrant and
Bioenvision, Inc. dated December 21, 1998 for the
acquisition of 7,013,897 shares of Registrant's Common
Stock by the stockholders of Bioenvision, Inc. (1)
2.2 Amended and Restated Agreement and Plan of Merger,
dated as of February 1, 2002, by and among Bioenvision,
Inc., Bioenvision Acquisition Corp. and Pathagon, Inc.
(5)
3.1 Certificate of Incorporation of Registrant. (2)
3.1(a) Amendment to Certificate of Incorporation filed January
29, 1999. (3)
3.1(b) Certificate of Correction to the Certificate of
Incorporation, filed March 15, 2002 (6)
3.1(c) Certificate of Amendment to the Certificate of
Incorporation, filed April 30, 2002 (6)
3.2 Amended and Restated By-Laws of the Registrant. (13)
3.2(a) Amendment to Bylaws, effective April 30, 2002 (6)
4.1 Certificate of Designation (6)
4.2 Form of Warrant (6)
4.3 Registration Rights Agreement, dated April 2, 2003, by
and between Bioenvision, Inc. and RRD International,
LLC (14)
4.4 Warrant, dated April 2, 2003, made by Bioenvision, Inc.
in favor of RRD International, LLC (14)
5.1* Opinion of Paul, Hastings, Janofsky & Walker, LLP
10.1 Pharmaceutical Development Agreement, dated as of June
10, 2003, by and between Bioenvision, Inc. and Ferro
Pfanstiehl Laboratories, Inc. (15)
10.2 Co-Development Agreement between Bioheal, Ltd. and
Christopher Wood dated May 19, 1998. (3)
10.3 Master Services Agreement, dated May 14, 2003, by and
between PennDevelopment Pharmaceutical Services Limited
and Bioenvision, Inc. (15)
10.4 Co-Development Agreement between Stegram
Pharmaceuticals, Ltd. And Bioenvision, Inc. dated July
15, 1998. (3)
10.5 Co-Development Agreement between Southern Research
Institute and Eurobiotech Group, Inc. dated August 31,
1998. (3)
10.5(a) Agreement to Grant License from Southern Research
Institute to Eurobiotech Group, Inc. dated September 1,
1998. (3)
10.6 License and Sub-License Agreement, dated as of May 13,
2003, by and between Bioenvision, Inc. and Dechra
Pharmaceuticals, plc (15)
10.7 Employment Agreement between Bioenvision, Inc. and
Christopher B. Wood, M.D., dated December 31, 2002 (3)
10.8 Employment Agreement between Bioenvision, Inc. and
David P. Luci, dated March 31, 2003. (14)
II-8
10.9 Securities Purchase Agreement with Bioaccelerate Inc
dated March 24, 2000. (4)
10.10 Engagement Letter Agreement, dated as of November 16,
2001, by and between Bioenvision, Inc. and SCO
Securities LLC. (7)
10.11 Security Agreement, dated as of November 16, 2001, by
Bioenvision, Inc. in favor of SCO Capital Partners LLC.
(7)
10.12 Commitment Letter, dated November 16, 2001, by and
between SCO Capital Partners LLC and Bioenvision, Inc.
(7)
10.13 Senior Secured Grid Note, dated November 16, 2001, by
Bioenvision, Inc. in favor of SCO Capital Partners LLC.
(7)
10.14 Registration Rights Agreement, dated as of February 1,
2002, by and among Bioenvision, Inc., the former
shareholders of Pathagon, Inc. party thereto,
Christopher Wood, Bioaccelerate Limited, Jano Holdings
Limited and Lifescience Ventures Limited. (8)
10.15 Stockholders Lock-Up Agreement, dated as of February 1,
2002, by and among Bioenvision, Inc., the former
shareholders of Pathagon, Inc. party thereto,
Christopher Wood, Bioaccelerate Limited, Jano Holdings
Limited and Lifescience Ventures Limited. (8)
10.16 Form of Securities Purchase Agreement by and among
Bioenvision, Inc. and certain purchasers, dated as of
May 7, 2002. (6)
10.17 Form of Registration Rights Agreement by and among
Bioenvision, Inc. and certain purchasers, dated as of
May 7, 2002. (6)
10.18 Exclusive License Agreement by and between Baxter
Healthcare Corporation, acting through its Edwards
Critical-Care division, and Implemed, dated as of May
6, 1997. (12)
10.19 License Agreement by and between Oklahoma Medical
Research Foundation and bridge Therapeutic Products,
Inc., dated as of January 1, 1998. (12)
10.20 Amendment No. 1 to License Agreement by and among
Oklahoma Medical Research Foundation, Bioenvision, Inc.
and Pathagon, Inc., dated May 7, 2002. (12)
10.21 Inter-Institutional Agreement between Sloan-Kettering
Institute for Cancer Research and Southern Research
Institute, dated as of August 31, 1998. (12)
10.22 License Agreement between University College London and
Bioenvision, Inc., dated March 1, 1999. (12)
10.23 Research Agreement between Stegram Pharmaceuticals
Ltd., Queen Mary and Westfield College and Bioenvision,
Inc., dated June 8, 1999 (12)
10.24 Research and License Agreement between Bioenvision,
Inc., Velindre NHS Trust and University College Cardiff
Consultants, dated as of January 9, 2001. (12)
10.25 Co-Development Agreement, between Bioenvision, Inc. and
ILEX Oncology, Inc., dated March 9, 2001. (12)
10.26 Amended and Restated Agreement and Plan of Merger,
dated as of February 1, 2002, among Bioenvision, Inc.,
Bioenvision Acquisition Corp. and Pathagon Inc. (5)
10.27 Master Services Agreement, dated as of April 2, 2003,
by and between Bioenvision, Inc. and RRD International,
LLC(14)
16.1 Letter from Graf Repetti & Co., LLP to the Securities
and Exchange Commission, dated September 30, 1999. (9)
II-9
16.2 Letter from Ernst & Young LLP to the Securities and
Exchange Commission, dated July 6, 2001. (10)
16.3 Letter from Ernst & Young LLP to the Securities and
Exchange Commission, dated August 16, 2001. (11)
21.1 Subsidiaries of the registrant (4)
23.1 Consent of Grant Thornton LLP
23.2* Consent of Paul, Hastings, Janofsky & Walker LLP
(included in Exhibit 5.1)
24.1 Power of Attorney (appears on signature page)
* To be filed by amendment.
-----------------------
(1) Incorporated by reference and filed as an Exhibit to Registrant's Current
Report on Form 8-K filed with the SEC on January 12, 1999.
(2) Incorporated by reference and filed as an Exhibit to Registrant's
Registration Statement on Form 10-12g filed with the SEC on September 3,
1998.
(3) Incorporated by reference and filed as an Exhibit to Registrant's Form
10-KSB/A filed with the SEC on October 18, 1999.
(4) Incorporated by reference and filed as an Exhibit to Registrant's Form
10-KSB filed with the SEC on November 13, 2000.
(5) Incorporated by reference and filed as an Exhibit to Registrant's Current
Report on Form 8-K filed with the SEC on April 16, 2002.
(6) Incorporated by reference and filed as an Exhibit to Registrant's Current
Report on Form 8-K, filed with the SEC on May 28, 2002.
(7) Incorporated by reference and filed as an Exhibit to Registrant's Current
Report on Form 8-K, filed with the SEC on January 8, 2002.
(8) Incorporated by reference and filed as an Exhibit to Registrant's Current
Report on Form 8-K, filed with the SEC on February 21, 2002.
(9) Incorporated by reference and filed as an Exhibit to Registrant's Current
Report on Form 8-K, filed with the SEC on October 1, 1999.
(10) Incorporated by reference and filed as an Exhibit to Registrant's Current
Report on Form 8-K/A, filed with the SEC on July 26, 2001.
(11) Incorporated by reference and filed as an Exhibit to Registrant's Current
Report on Form 8-K, filed with the SEC on December 6, 2001.
(12) Incorporated by reference and filed as an Exhibit to Registrant's Current
Report on Form 8-K, filed with the SEC on June 24, 2002.
(13) Incorporated by reference and filed as an Exhibit to Registrant's
Quarterly Report on Form 10-QSB for the three-month period ended December
31, 2002.
(14) Incorporated by reference and filed as an Exhibit to Registrant's
Quarterly Report on Form 10-QSB for the three-month period ended March
31, 2003.
(15) Incorporated by reference and filed as an Exhibit to Registrant's Form
10-KSB filed with the SEC on September 29, 2003.
II-10