<PAGE>
As filed with the Securities and Exchange Commission on December 15, 2000
Registration No. 333-_____
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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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Form S-3
REGISTRATION STATEMENT
Under
THE SECURITIES ACT OF 1933
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IMPAX LABORATORIES, INC.
(Exact name of registrant as specified in its charter)
Delaware 65-0403311
(State or other jurisdiction of (I.R.S. Employer Identification
incorporation or organization) Number)
30831 Huntwood Avenue
Hayward, CA 94544
(510) 471-3600
(Address, including zip code, and telephone number,
including area code, of principal executive offices)
BARRY R. EDWARDS
Co-Chief Executive Officer
IMPAX LABORATORIES, INC.
3735 Castor Avenue
Philadelphia, PA 19124
215-289-2220
(Name, address, including zip code, and telephone number,
including area code, of agent for service)
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Copies of all communications, including all communications sent to the
agent for service, should be sent to:
SOL GENAUER, ESQ.
Blank Rome Comisky & McCauley LLP
One Logan Square
Philadelphia, PA 19103-6998
(215) 569-5500
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Approximate date of proposed sale to the public: From time to time after
the effective date of this Registration Statement.
If the only securities being registered on this Form are being offered
pursuant to dividend or interest reinvestment plans, please check the following
box. |_|
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, as amended, other than securities offered only in connection with dividend
or interest reinvestment plans, 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, please 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 delivery of the prospectus is expected to be made pursuant to Rule 434,
please check the following box. |_|
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<PAGE>
Calculation of Registration Fee
<TABLE>
<CAPTION>
============================ =================== ======================= ========================= ===================
Proposed maximum Proposed maximum
Title of shares Amount offering price per aggregate offering price Amount of
to be registered To be registered unit Registration fee
---------------------------- ------------------- ----------------------- ------------------------- -------------------
<S> <C> <C> <C> <C>
Common Stock, $.01
par value per share. . . . 2,739,216 $6.1875 (1) $16,948,899 $4,475
========================== =================== ======================= ========================= ===================
</TABLE>
(1) Estimated in accordance with Rule 457(c) under the Securities Act of
1933, as amended, solely for the purpose of calculating the
registration fee, based upon the average of the high and low prices per
share of Common Stock on the NASDAQ National Market on December 14,
2000.
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The Registrant hereby amends this Registration Statement on such date
or dates as may be necessary to delay its effective date until the Registrant
shall file a further amendment which specifically states that this Registration
Statement shall thereafter become effective in accordance with Section 8(a) of
the Securities Act of 1933 or until the Registration Statement shall become
effective on such date as the Commission, acting pursuant to said Section 8(a),
may determine.
<PAGE>
PROSPECTUS
IMPAX LABORATORIES, INC.
2,739,216 Shares
Common Stock
These 2,739,216 shares of our common stock are being offered for sale
by the selling stockholders named on page 12 of this prospectus. We
will not receive any part of the proceeds from these sales.
Our common stock trades on the Nasdaq National Market under the symbol
"IPXL." On December 14, 2000, the closing sale price of our common
stock was $5.9375 per share.
Our principal executive officers are located at Impax Laboratories,
Inc., 30831 Huntwood Avenue, Hayward, California, 94544 and our
telephone number is (510) 471-3600.
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You are urged to carefully read the "Risk Factors" section beginning on
page 1 of this Prospectus, which describes specific risks and certain other
information associated with an investment in our company that should be
considered before you make your investment decision.
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Neither the Securities and Exchange Commission nor any state securities
commission has approved or disapproved of these securities or passed upon the
adequacy of this Prospectus. Any representation to the contrary is a criminal
offense.
The date of this Prospectus is December 15, 2000
<PAGE>
TABLE OF CONTENTS
Page
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Risk Factors ..............................................................1
Where You Can Find More Information .......................................10
Use of Proceeds ...........................................................11
Selling Stockholders ......................................................12
Plan of Distribution ......................................................12
Legal Matters .............................................................14
Experts ...................................................................14
i
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RISK FACTORS
An investment in our common stock involves a high degree of risk. You should
consider carefully the following risk factors, as well as the other information
included in this prospectus, in deciding whether to invest in our common stock.
This prospectus contains forward-looking statements that involve risks and
uncertainties. Our actual results could differ materially from the results
discussed in the forward-looking statements. Factors that could cause or
contribute to these differences include, but are not limited to, those discussed
in this "risk factors" section, and elsewhere in this prospectus.
If we are unable to obtain additional financing, our limited supply of funds may
require us to modify our business operations and plans by spending less money on
research and development programs, developing fewer products and filing fewer
drug applications with the FDA.
As of December 13, 2000, we had approximately $20 million of unrestricted funds.
We estimate that these funds will be sufficient for the next twelve months of
operations at our planned expenditure levels. The exact amount and timing of
future capital requirements will depend upon many factors, including continued
progress with our research and development programs, expansion of such programs,
the approval and launch of new products, as well as the amount of revenues
generated by our existing products. We may not be successful in obtaining
additional capital in amounts sufficient to fund our operations. Additional
financing also may not be available to us on terms favorable to us or our
stockholders, or at all. In the event that adequate funds are not available, our
business operations and plans may need to be modified. This could result in less
money being spent on research and development programs, fewer products being
developed and at a slower pace, and fewer drug applications being filed with the
FDA.
Our limited capital may make it difficult for us to repay our outstanding
indebtedness.
We may not be able to maintain adequate capital at any given time or from time
to time in the future. As of September 30, 2000, we had outstanding
approximately $4,530,000 of indebtedness, bearing interest at rates ranging from
2% to 10.5% annually. Of this indebtedness, $2,696,000 was owed to General
Electric Credit Corporation under our revolving credit facility. The facility
expires in July 2001. Additionally, as of September 30, 2000, we had a
stockholders' accumulated deficit of approximately $39,387,000.
Our stockholders may sustain dilution in ownership or be adversely affected by
strategic alliance or licensing arrangements we make with other companies.
We need to raise additional capital in the future to fund our planned expansion.
To the extent we raise additional capital by issuing equity securities,
ownership dilution to our stockholders will result. To the extent we raise
additional funds through strategic alliance and licensing arrangements, we may
be required to relinquish rights to certain of our technologies or product
candidates, or to grant licenses on terms that are not favorable to us, either
of which could reduce our value.
The time necessary to develop generic drugs may adversely affect when and the
rate at which we receive a return on our capital.
We begin our development activities for a new generic drug product several years
in advance of the patent expiration date of the brand name drug equivalent. The
development process, including drug formulation, testing and FDA approval
generally takes three or more years. This process requires that we expend
considerable capital to activities that do not yield an immediate or near-term
return. Also, because of the significant time necessary to develop a product,
the actual market for a product at the time it is available for sale may be
significantly less than the originally projected market for the product. Our
return on investment to develop the product will then be adversely affected.
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We have experienced and continue to experience operating losses, and the highly
regulated nature of our business makes our future profitability uncertain.
We do not know whether or when our business will ever be profitable. We have
generated minimal revenues to date and have experienced operating losses since
our inception. As of September 30, 2000, our accumulated deficit was $39,387,000
and we had outstanding indebtedness in an aggregate principal amount of
$4,530,000. To remain operational, we must:
o Properly receive, warehouse and store raw materials and supplies;
o Maintain work in progress in compliance with regulatory requirements
and properly store finished goods;
o Properly manufacture various formulations, dosages and
configurations of a potentially broad product line;
o Meet strict security requirements for virtually every activity
undertaken at the plant;
o Maintain appropriate laboratory, quality control and quality
assurance practices and procedures; and
o Comply with the many complex governmental regulations that deal
with virtually every aspect of our business activities.
Operating our business successfully also will depend, in part, on a variety of
factors outside of our control, including:
o Changes in raw material supplies and suppliers;
o Changes in governmental programs and requirements;
o Changes in physician or consumer preferences; and
o Changes in FDA and similar regulatory requirements.
Our revenues have fluctuated and could fluctuate significantly in the future,
which may have a material adverse effect on our results of operations and stock
price.
Our revenues may vary significantly from fiscal quarter to fiscal quarter as
well as in comparison to the corresponding fiscal quarter of the preceding year.
Variations of those types may result from, among other factors:
o The timing of FDA approvals we receive;
o The timing of process validation for particular generic drug
products;
o The timing of any significant initial shipments of newly approved
drugs; and
o Competition from other generic drug manufacturers that receive FDA
approvals for competing products.
We cannot predict whether our business will be seasonal in nature.
Products that we manufacture and distribute pertaining to seasonal ailments such
as allergies or colds may experience seasonal patterns in sales and
profitability. The potential seasonality of our business may have a material
adverse effect on our results of operations and stock price.
Restrictive FDA regulations govern the manufacturing and distribution of our
products.
The FDA also regulates the development, manufacture, distribution, labeling and
promotion of prescription drugs, requires that certain records be kept and
reports be made, mandates registration of drug manufacturers and listing of
their products and has the authority to inspect manufacturing facilities for
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compliance with current good manufacturing practices ("cGMP"), standards. Our
business and financial results could be materially harmed by any failure to
comply with licensing and other requirements.
Other requirements exist for controlled drugs, such as narcotics, which are
regulated by the U.S. Drug Enforcement Administration ("DEA"). Further, the FDA
has the authority to withdraw approvals of previously approved drugs for cause,
to request recalls of products, to bar companies and individuals from future
drug application submissions and, through action in court, to seize products,
institute criminal prosecution or close manufacturing plants in response to
violations. The DEA has similar authority and may also pursue monetary
penalties. Our business and financial results could be materially harmed by
these requirements or FDA or DEA actions.
The FDA may not approve our future products, in which case our ability to
generate product revenues will be adversely affected.
The testing, manufacturing and marketing of our products generally are subject
to extensive regulation and approvals by numerous government authorities in the
United States and other countries. We may not receive FDA approvals for
additional products on a timely basis, or at all. Any delay in our obtaining or
any failure to obtain these approvals would adversely affect our ability to
generate product revenue. Also, the process of seeking FDA approvals can be
costly, time consuming, and subject to unanticipated and significant delays.
We only have a limited number of commercialized products and these and other
products typically have declining revenues over their product lives.
To date, the FDA has approved the ANDAs for four of our products. We commenced
marketing all of these but currently are manufacturing and marketing only two.
We cannot assure you that our other products under development or products
submitted to the FDA will be approved by the FDA or other regulatory authorities
or that our development efforts will be successfully completed. Our future
results of operations will depend significantly upon our ability to develop and
market our existing and new pharmaceutical products. Our operating results may
vary significantly on an annual or quarterly basis depending on the timing of,
and our ability to obtain, FDA approvals for such new products. Newly introduced
bioequivalent pharmaceuticals with limited or no competition are typically sold
at higher selling prices, often resulting in higher gross profit margins. As
competition from other manufacturers intensifies, selling prices and gross
profit margins typically decline, which has been our experience with our
existing products. The timing of our future operating results may also be
affected by a variety of additional factors, including the results of future
patent challenges and the market acceptance of our new products.
We face intense competition in the pharmaceutical industry from both brand name
and bioequivalent manufacturers, wholesalers and distributors that could
severely limit our growth.
The pharmaceutical industry is highly competitive and many of our competitors
have longer operating histories and greater financial, research and development,
marketing and other resources than us. We are subject to competition from
numerous other entities that currently operate or intend to operate in the
pharmaceutical industry, including companies that are engaged in the development
of controlled release drug delivery technologies and products and other
manufacturers that may decide to undertake in-house development of these
products. Our bioequivalent products may be subject to competition from
competing bioequivalent products marketed by the patent holder. We cannot assure
you that we will be able to continue to compete successfully with these
companies.
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We will need an effective sales organization to market and sell our future brand
products and our failure to have an effective sales organization may harm our
business.
Currently we do not have an active sales division to market and sell our brand
products that we may develop or acquire. We cannot assure you that prior to the
time these products are available for commercial launch we will be able to
recruit qualified individuals for our Impax Pharmaceuticals division. Our
inability to enter into satisfactory sales and marketing arrangements in the
future may materially harm our business and financial results. We may have to
rely on collaborative partners to market our products. These partners may not
have the same interests as us in marketing the products and we may lose control
over the sales of these products.
Decreases in healthcare reimbursements could limit our ability to sell our
products or decrease our revenues.
Our ability to maintain our revenues in our distribution business or to
commercialize our product candidates depends in part on the extent to which
reimbursement for the cost of pharmaceuticals will be available from government
health administration agencies, private health insurers and other organizations.
In addition, third party payors are attempting to control costs by limiting the
level of reimbursement for medical products, including pharmaceuticals, which
may adversely affect the pricing of our product candidates. Moreover, healthcare
reform has been, and may continue to be, an area of national and state focus,
which could result in the adoption of measures that could adversely affect the
pricing of pharmaceuticals or the amount of reimbursement available from third
party payors. We cannot assure you that healthcare providers, patients or third
party payors will accept and pay for our pharmaceuticals. In addition, there is
no guarantee that healthcare reimbursement laws or policies will not materially
harm our ability to sell our products profitably or prevent us from realizing an
appropriate return on our investment in product development.
We are subject to an outstanding court order governing manufacture of our
products that may adversely affect our product introduction plans and results of
operations.
On May 25, 1993, the United States District Court for the Eastern District of
Pennsylvania issued an order against Richlyn Laboratories, Inc. that, among
other things, permanently enjoined Richlyn from selling any drug manufactured,
processed, packed or labeled at its Philadelphia facility unless it met certain
stipulated conditions. When we acquired the facilities and drug applications of
Richlyn, we became subject to the conditions in that court order. The order
requires, in part, that the FDA find that products manufactured, processed and
packed at the former Richlyn facility conform with FDA regulations concerning
cGMP before the products can be marketed.
Although we were informed in January 1998 that product by product inspection and
prior authorization was no longer required in order for us to manufacture and
sell products, we cannot give any assurance that the FDA will not reverse or
reconsider its position and again require product by product inspection and
prior authorization. Requiring such inspection and authorization would subject
us to a higher level of scrutiny then is standard for the generic pharmaceutical
manufacturing industry. Any reversal or reconsideration by the FDA will delay
product introduction plans.
The order against Richlyn also requires that we hire and retain a person,
subject to FDA approval, who is qualified to inspect our drug manufacturing
facilities to determine that our methods, facilities and controls are operated
and administered in compliance with cGMP. This person must examine all drug
products manufactured, processed, packed and held at our facility and certify in
writing to the FDA our compliance with related cGMP. We have contracted with a
local consultant to conduct this compliance review. In addition to the cost and
expense of this examination, we may not be able to maintain compliance with
cGMP, which would severely restrict our operations.
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We depend on our patents and trade secrets and our future success is dependent
on our ability to protect these secrets and not infringe on the rights of
others.
We believe that patent and trade secret protection is important to our business
and that our future success will depend in part on our ability to obtain
patents, maintain trade secret protection and operate without infringing on the
rights of others. We have been issued one U.S. patent and have filed additional
U.S. and various foreign patent applications relating to our drug delivery
technologies. We expect to apply for additional U.S. and foreign patents in the
future. The issuance of a patent is not conclusive as to its validity or as to
the enforceable scope of the claims of the patent. We cannot assure you that:
o our patents or any future patents will prevent other companies from
developing similar or functionally equivalent products or from
successfully challenging the validity of our patents;
o any of our future processes or products will be patentable;
o any pending or additional patents will be issued in any or all
appropriate jurisdictions;
o our processes or products will not infringe upon the patents of
third parties; or
o we will have the resources to defend against charges of patent
infringement by third parties or to protect our own patent rights
against infringement by third parties.
Our business and financial results could be materially harmed if we fail to
avoid infringement of the patent or proprietary rights of others or to protect
our patent rights.
We have exposure to patent infringement litigation as a result of our product
development efforts, which could adversely affect our product introduction
efforts and be costly.
The patent position of pharmaceutical firms involves many complex legal and
technical issues and has recently been the subject of much litigation. There is
no clear policy establishing the breadth of claims allowed or the degree of
protection afforded under these patents. During the past several years, there is
an increasing tendency for the innovator of the original patented product to
bring patent litigation against a generic drug company. This litigation is often
initiated as an attempt to delay the entry of the generic drug product and
reduce its market penetration.
As of September 30, 2000, we have purchased $7 million of patent infringement
liability insurance coverage under the Hatch-Waxman Act provisions relating to
Paragraph IV Certification. There can be no assurance that the insurance
coverage will be sufficient to cover any liability resulting from alleged or
proven patent infringement.
Pharmaceutical drug makers face an inherent risk of product liability litigation
and any claims brought against us could have a material adverse effect upon us.
The design, development and manufacture of our products involve an inherent risk
of product liability claims and associated adverse publicity. Insurance coverage
is expensive, difficult to obtain and may not be available in the future on
acceptable terms or at all. Any claims brought against us, whether fully covered
by insurance or not, could have a material adverse effect upon us.
Our business is subject to substantial litigation that could expose us to
unfavorable claims.
We have and continue to face substantial patent infringement litigation with
respect to the manufacture, use and sale of our products. To date, the following
actions have been filed against us in connection with certain of the ANDAs we
have filed containing certifications relating to infringement, validity or
enforceability of patents:
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In May, 2000, an action was filed against us in the United States District Court
of Delaware (CV-00-479) by ASTRAZENECA AB, AKTIEBOLAGET HASSLE, KBI-E INC, KBI
INC and ASTRAZENECA, L.P. The action alleges patent infringement by us based
upon the Company's ANDA filed with the FDA for the Omeprazole Delayed Released
Capsule, a generic version of plaintiffs' Prilosec(R) product. The action seeks
to enjoin us from marketing Omeprazole Delayed Release Capsules until February
2, 2014, and asks for an award of attorneys' fees and costs and expenses in
connection with the action. In the ANDA, we are not challenging the basic
Omeprazole patent that expires in 2001; rather we have asserted that our
specific formulation does not infringe other patents listed by AstraZeneca PLC
in connection with Prilosec. There can be no assurance that we will be
successful in our defense of the patent infringement claim. If AstraZeneca PLC
is successful in its lawsuit, any resulting liability could have a material
adverse effect on us. We do not believe that we have infringed any patents of
the plaintiffs and intend to vigorously defend that position.
In August, 2000, Abbott Laboratories, Inc. and Fournier Industries et Sante and
a related company, filed suit against us in the United States District Court in
Chicago, Illinois (OOC-5092) claiming that our submission of an ANDA for
Fenofibrate (Micronized) Capsules, 67mg, constitutes infringement of a U.S.
patent owned by Fournier, which is exclusively licensed to Abbott's TRICOR(R)
product line. The action seeks to enjoin us from marketing the Fenofibrate
(Micronized) Capsules until January 19, 2009, asks for damages and/or other
monetary relief for any commercial manufacture, use or sale of the fenofibrate
falling within the scope of one or more claims of the plaintiffs' patent and
asks for an award of the plaintiffs' costs and attorneys' fees in connection
with the action. We do not believe that we have infringed any patents of the
plaintiffs and intend to vigorously defend that position.
In October, 2000, Glaxo Wellcome, Inc. filed suit against us in the United
States District Court, Northern District Court of California (COO-21009)
claiming that our submission of Bupropion Hydrochloride Sustained Release
Tablets constitutes infringement of a U.S. patent owned by Glaxo Wellcome. The
action seeks to enjoin us from receiving approval of its application prior to
the expiration date of Glaxo Wellcome's patent, award the plaintiff preliminary
and final injunctions enjoining us from continued infringement of its patent and
award the plaintiff such other and further relief as the Court may deem proper.
We do not believe that we have infringed any patents of the plaintiff and intend
to vigorously defend that position.
We anticipate that additional actions may be filed as we file additional ANDAs.
Patent litigation may also be brought against us in connection with certain NDA
products that we may pursue. The outcome of this type of litigation is difficult
to predict because of the uncertainties inherent in patent litigation. Prior to
filing an ANDA or NDA, we evaluate the probability of patent infringement
litigation on a case-by-case basis and have reserved for the estimated patent
infringement litigation costs. Our business and financial results could be
materially harmed by the delays in marketing our products as a result of
litigation, an unfavorable outcome in any litigation or the expense of
litigation whether or not it is successful.
We have exposure under DES-related product liability claims, which could have a
material adverse effect upon our financial condition.
When we acquired the business of Richlyn, we also assumed its liabilities in
connection with Diethyl Stilbestrol, commonly known as DES, which was
manufactured by Richlyn and many other drug manufacturers during the late 1950's
and early 1960's. DES was prescribed to pregnant women during that period and
has been alleged to cause birth defects, in particular an increased risk of
uterine cancer and sterility of female children whose mothers took the drug
during their pregnancy. There have been numerous claims brought against drug
manufacturers relating to DES and, since 1987, Richlyn's insurers have paid
approximately $136,000 on their behalf and our behalf to settle approximately
143 DES-related suits. No other legal actions have been brought or, to our
knowledge, threatened against Richlyn or us in connection with DES-related
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claims. We do not expect to be held liable for DES-related claims other than
claims based on products manufactured by Richlyn. Claims settlements to date
have been based on market share and we believe Richlyn's share of the DES market
during the relevant periods was substantially less than 1%.
Our compliance with environmental laws may necessitate uncertain expenditures in
the future, the capital for which may not be available to us.
We cannot accurately predict the outcome or timing of future expenditures that
we may be required to pay in order to comply with comprehensive federal, state
and local environmental laws and regulations. We must comply with environmental
laws that govern, among other things, all emissions, waste water discharge and
solid and hazardous waste disposal, and the remediation of contamination
associated with generation, handling and disposal activities. We are subject
periodically to environmental compliance reviews by various regulatory offices.
Environmental laws have changed in recent years and we may become subject to
stricter environmental standards in the future and face larger capital
expenditures in order to comply with environmental laws. Our limited capital
makes it uncertain whether we will be able to pay for these larger than expected
capital expenditures. Also, future developments, administrative actions or
liabilities relating to environmental matters may have a material adverse effect
on our financial condition or results of operations.
Generic drug makers are most profitable when they are the first producer of a
generic drug, and we do not know if we will be the first maker of any generic
drug product.
The first generic drug manufacturers receiving FDA approval for generic
equivalents of related brand name products have historically captured
significant market share enabling it to extract greater profits from the branded
product than later arriving manufacturers. The development of a new generic drug
product, including its formulation, testing and FDA approval, generally takes
approximately three or more years. Consequently, we may select drugs for
development several years in advance of their anticipated entry to market, and
cannot know what the market or level of competition will be for that particular
product when we begin selling the product. Our profitability, if any, will
depend, in part on:
o Our ability to develop and rapidly introduce new products;
o The timing of FDA approvals of our products; and
o The number and timing of FDA approvals for competing products.
In addition, by introducing generic versions of their own branded products prior
to the expiration of the patents for those drugs, brand name drug companies have
attempted to prevent generic drug manufacturers from producing certain products.
Brand name companies have also attempted to prevent competing generic drug
products from being treated as equivalent to their brand name products. We
expect efforts of this type to continue.
We are dependent on a small number of products to generate revenues to fund our
business and operations.
Our long-term success is dependent, among other factors, on our ability to offer
and sell a broad line of products. We intend to introduce products on a selected
basis. Consequently, we will be dependent, particularly in the near-term, upon a
relatively small number of products to generate revenues. As a result, if we
misjudge the market for or are delayed in the production of a particular
product, our business can be materially adversely affected.
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We are dependent on a small number of suppliers for our raw materials, and any
delay or unavailability of raw materials can materially adversely affect our
ability to produce products.
The FDA requires specification of raw material suppliers in applications for
approval of drug products. If raw materials were unavailable from a specified
supplier, FDA approval of a new supplier could delay the manufacture of the drug
involved. In addition, some materials used in our products are currently
available from only one or a limited number of suppliers. Further, a significant
portion of our raw materials may be available only from foreign sources. Foreign
sources can be subject to the special risks of doing business abroad, including:
o Greater possibility for disruption due to transportation or
communication problems;
o The relative instability of foreign governments and economies;
o Interim price volatility based on labor unrest or materials or
equipment shortages; and
o Uncertainty regarding recourse to a dependable legal system for the
enforcement of contracts and other rights.
The delay or unavailability of raw materials can materially adversely affect our
ability to produce products. This can materially adversely affect our business
and operations.
If certain holders of our equity exercise their rights to acquire shares of
common stock, it may lower the future value of the common stock.
At September 30, 2000, there were a total of 217,300 shares outstanding of our
Series 1 Preferred Stock and 150,000 shares of our Series 2 Preferred Stock. At
September 30, 2000, these shares were convertible, at any time at the option of
their holders, into an aggregate of 16,661,525 shares of our common stock. The
shares of preferred stock also have anti-dilution protections if we were to
issue stock for a price below stated levels, which could make them convertible
into additional shares of common stock. In addition, at September 30, 2000,
there were outstanding warrants and options to purchase an aggregate of
6,134,156 shares of our common stock at exercise prices ranging from $0.75 to
$13.175 per share of common stock. Consequently, any exercise of these options
or warrants could dilute the future value of our common stock.
We have and may in the future issue additional preferred stock that could
adversely affect the rights of holders of our common stock.
Our Board of Directors has the authority to issue up to 2,000,000 shares of our
preferred stock and to determine the price, rights, preferences and privileges
of those shares without any further vote or action by the stockholders (except
that the rights, preferences and privileges may not be more favorable to the
stockholder than the Series 1 Preferred Stock and Series 2 Preferred Stock,
without the approval of holders of the Series 1 Preferred Stock and Series 2
Preferred Stock). We presently have outstanding 50,000 shares of Series 1-A
Preferred Stock, 167,300 shares of Series 1-B Preferred Stock, and 150,000
shares of Series 2 Preferred Stock. Preferred stockholders could adversely
affect the rights of holders of common stock by:
o Exercising voting, redemption and conversion rights to the detriment
of the holders of common stock;
o Receiving preferences over the holders of common stock regarding
assets or surplus funds in the event of our dissolution or
liquidation;
o Delaying, deferring or preventing a change in control of our
company;
o Discouraging bids for our common stock at a premium over the market
price of the common stock; and
o Otherwise adversely affecting the market price of the common stock.
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Control of our company is concentrated among a limited number of stockholders,
who can exercise significant influence over all matters requiring stockholder
approval.
As of September 30, 2000, our present directors, executive officers and their
respective affiliates and related entities beneficially owned approximately 53%
of our common stock and common stock equivalents. These stockholders can
exercise significant influence over all matters requiring stockholder approval,
including the election of directors and the approval of significant corporate
transactions. This concentration of ownership may also potentially delay or
prevent a change in control of our company. In addition, holders of
approximately 64% of our outstanding voting stock have entered into an agreement
committing them to vote their shares of stock until December 14, 2002 for the
election as directors of the individuals designated each year by the former
boards of Global and Impax Pharmaceuticals, Inc. prior to our merger.
We depend on key officers and qualified scientific and technical employees and
our limited resources may make it more difficult to attract and retain these
personnel.
As a small company with, as of September 30, 2000, only approximately 110
employees, the success of our present and future operations will depend to a
great extent on the collective experience, abilities and continued service of
certain of our executive officers. If we lose the services of any of these
executive officers, it could have a material adverse effect on us. Because of
the specialized scientific nature of our business, we are also highly dependent
upon our ability to continue to attract and retain qualified scientific and
technical personnel. Loss of the services of, or failure to recruit, key
scientific and technical personnel would be significantly detrimental to our
product development programs. Our small size and limited resources may make it
more difficult for us to attract and retain our executive officers and qualified
scientific and technical personnel.
We have limited manufacturing capacity and need to acquire or build additional
capacity for products in our pipeline. Our manufacturing facilities must comply
with stringent FDA and other regulatory requirements.
We have an approximately 36,000 square foot commercial manufacturing facility in
Hayward, CA. This facility is currently being used to manufacture two of our
currently marketed products. We have ceased the manufacture of our products in
our 113,000 square foot facility in Philadelphia, PA. Although the Hayward
facility is expected to be sufficient for the manufacture of certain products
that were previously manufactured in Philadelphia, it will not be suitable for
the manufacture of all of the products that we intend to develop and
manufacture. We will need to scale up our current manufacturing operations
significantly. We are in the process of expanding our facilities for
manufacturing operations.
In addition to obtaining the appropriate licenses and permits to build the new
facilities, the new manufacturing facilities, once completed, will need to be in
compliance with cGMP and inspected. We cannot assure you that such permits,
licenses and approvals will be obtained or, if obtained, obtained in time to
manufacture additional products as they are approved. Our facilities will be
subject to periodic inspections by the FDA and we cannot assure you that the
facilities will continue to be in compliance with cGMP or other regulatory
requirements. Failure to comply with such requirements could result in
significant delays in the development, approval and distribution of our planned
products, and may require us to incur significant additional expense to comply
with cGMP or other regulatory requirements. We cannot assure you that we will be
able to manufacture our products successfully on a commercial scale. Further, we
will depend on other companies to manufacture certain of the product candidates
under development.
9
<PAGE>
The DEA also periodically inspects facilities for compliance with security,
recordkeeping, and other requirements that govern controlled substances. We
cannot assure you that we will be in compliance with DEA requirements in the
future.
If we are unable to manage our rapid growth, our business will suffer.
We have experienced rapid growth of our operations. This growth has required us
to expand, upgrade and improve our administrative, operational and management
systems, controls and resources. We anticipate additional growth in connection
with the expansion of our manufacturing operations, development of our brand
products, our marketing and sales efforts for the products we develop, the
development and manufacturing efforts for our products and Internet operations.
If we fail to manage growth effectively or to develop a successful marketing
approach, our business and financial results will be materially harmed.
The anti-takeover provisions of our charter documents and Delaware law could
affect shareholders.
Certain provisions of our amended and restated articles of incorporation and
bylaws may have anti-takeover effects and may delay, defer or prevent a takeover
attempt of the Company. The Company is subject to the anti-takeover provisions
of the Delaware General Business Corporation Law.
We do not plan to declare dividends.
We have not paid any cash dividends on our common stock and we do not plan to
pay any cash dividends in the foreseeable future. We plan to retain any earnings
for the operation and expansion of our business.
WHERE YOU CAN FIND MORE INFORMATION
We file annual, quarterly and special reports, proxy statements and
other information with the Securities and Exchange Commission. You may inspect
and copy any document we file at the SEC's Public Reference Room at 450 Fifth
Street, N.W., Washington, D.C. 20549 or at the SEC's other public reference
facilities in New York, New York, or Chicago, Illinois. Please call the SEC at
1-800-SEC-0330 for further information on the public reference rooms. Our SEC
filings are also available to the public from the SEC's web site on the Internet
at http://www.sec.gov. This web site contains reports, proxy and information
statements and other information regarding our company and other registrants
that file electronically with the SEC.
We have filed a registration statement on Form S-3 with the SEC
covering the shares of common stock being offered by means of this prospectus.
We are allowed to "incorporate by reference" the information contained in
documents we file with the SEC, which means that we can disclose important
information to you by referring you to those documents. The information
incorporated by reference is considered to be part of this prospectus, and later
information that we file with the SEC will automatically update and supersede
this information. We incorporate by reference the documents listed below, and
any future filings made with the SEC under Sections 13(a), 13(c), 14 or 15(d) of
the Securities Exchange Act of 1934, until the selling stockholders sell all the
shares:
1. Our annual report on Form 10-KSB for the year ended December 31,
1999;
2. Our quarterly reports on Form 10-QSB for the quarters ended March
31, 2000, June 30, 2000 and September 30, 2000;
3. Our current reports on Form 8-K filed on May 16, 2000 and August 22,
2000; and
10
<PAGE>
4. The description of our common stock contained in our registration
statement on Form 8-A filed on December 8, 1995, as amended on December 14,
1997.
You may request a copy of these filings, at no cost, by writing or
telephoning our Secretary at Impax Laboratories, Inc., 30831 Huntwood Avenue,
Hayward, California 94544, telephone number (510) 471-3600.
You should rely on the information incorporated by reference or
provided in this prospectus or any supplement. We have not authorized anyone
else to provide you with different information. The selling stockholders will
not make an offer of these shares in any state where the offer is not permitted.
You should not assume that the information in this prospectus or any supplement
is accurate as of any date other than the date on the front of those documents.
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
In this prospectus, we have made forward-looking statements relating to
the future results of our company. These statements are based on our estimates
and assumptions and are subject to a number of risks and uncertainties.
Forward-looking statements are preceded or followed by the words "anticipates,"
"believes," "estimates," "expects," "hopes," "targets" or similar expressions.
Our future results could be affected by subsequent events and could
differ materially from those expressed in the forward-looking statements. If
further events and actual performance differ from our assumption, actual results
could vary significantly from the performance projected in the forward-looking
statements.
The following important factors, along with those discussed elsewhere
in this prospectus, could affect our future results and could cause those
results to differ materially from those expressed in the forward-looking
statements:
o our ability to combine operations and obtain revenue enhancements
and cost savings following the recently completed merger of Impax
Pharmaceuticals, Inc. and Global Pharmaceutical Corporation (which
formed our company under our new name, Impax Laboratories, Inc.);
o material adverse changes in economic conditions in the markets
served by our company;
o material changes in available technology; and
o the extent, success and overall effects of competition from others
in the pharmaceutical markets.
USE OF PROCEEDS
We will not receive any proceeds from the sale of the shares of our
common stock by the selling stockholders.
11
<PAGE>
SELLING STOCKHOLDERS
The table below sets forth information as of December 7, 2000 with
respect to the number and percentage of shares of common stock beneficially
owned by each of the selling stockholders and the number of shares being offered
for sale by each selling stockholder.
<TABLE>
<CAPTION>
Shares of Common Number of Shares of Common
Stock Beneficially Shares Stock Beneficially
Owned Before this Being Owned After this
Selling Stockholder Offering Offered Offering
--------------------------------------------- -------------------------- ------------- ------------------------
Number(1) Percent Number(1) Percent
------------- --------- ---------- ----------
<S> <C> <C> <C> <C> <C>
Anvil Investment Associates, L.P. 218,767 * 166,667 52,100 *
Ashford Capital Partners, L.P. 237,766 * 166,666 71,100 *
CCM Investments Limited 6,074,487(2) 19.6 333,333 5,741,154 20.6
Fleming US Discovery Fund III, L.P.(3) 4,704,619 14.7 718,167 3,986,452 13.5
Fleming US Discovery Offshore Fund III, L.P.(3) 753,715 2.6 115,167 638,548 2.1
Charles Hsiao, Ph.D. 5,115,555(4) 17.7 172,581 4,942,974 19.1
Narragansett I, L.P. 32,500 * 32,500 -- --
Narragansett Offshore Ltd. 50,835 * 50,835 -- --
Robert Fleming Nominees Limited 833,300 3.0 833,300 -- --
SDS Merchant Fund, L.P. 50,000 * 50,000 -- --
S/G MedScience Fund, L.P. 100,000 * 100,000 -- --
</TABLE>
-------------------
* less than 1%
(1) The number of shares beneficially owned includes shares issuable upon
conversion of Series 1 Preferred Stock, Series 2 Preferred Stock and shares
issuable within 60 days upon exercise of outstanding warrants and options.
(2) Include shares beneficially owned by Chemical Company of Malaysia Berhad
which is the 100% owner of CCM Investments Limited. An executive officer of
Chemical Company of Malaysia or its affiliates has served on our Board of
Directors during the three years prior to the date of this prospectus.
(3) An employee of Robert Fleming Inc., the fund manager of Fleming US
Discovery Fund III, L.P. and Fleming US Discovery Offshore Fund III, L.P.,
has served as a member of our Board of Directors during the two years prior
to the date of this prospectus.
(4) Includes 500,370 shares of common stock held in trust for the benefit of
John Hsiao's children and 250,185 shares of common stock held in trust for
the benefit of Richard Hsiao's children. Does not include 2,601,924 shares
of common stock held in the Chiin Hsiao's Childrens' Irrevocable Trust, as
to which shares Dr. Hsiao does not have voting or dispositive power. Mr.
Hsiao serves as our Chairman of the Board of Directors and as our Co-Chief
Executive Officer.
PLAN OF DISTRIBUTION
We are registering the shares of common stock on behalf of the selling
stockholders. We will pay all costs, expenses and fees in connection with this
registration, except that the selling stockholders will pay underwriting
discounts and selling commissions, if any. We will not receive any of the
proceeds from the sale of the shares by the selling stockholders. When we refer
to the "selling stockholders" in this prospectus, that term includes donees and
pledgees selling shares of common stock under this prospectus which were
received from the selling stockholders.
12
<PAGE>
The selling stockholders may sell their shares at various times in one
or more of the following transactions:
o on the Nasdaq National Market (or any other exchange on which the
shares may be listed);
o in the over-the-counter market;
o in negotiated transactions other than on such exchange;
o by pledge to secure debts and other obligations;
o in connection with the writing of non-traded and exchange-traded
call options, in hedge transactions, in covering previously
established short positions and in settlement of other transactions
in standardized or over-the-counter options; or
o in a combination of any of the above transactions.
The selling stockholders may sell their shares at market prices
prevailing at the time of sale, at prices related to such prevailing market
prices, at negotiated prices or at fixed prices. The selling stockholders may
sell shares directly or may use broker-dealers to sell their shares. The
broker-dealers will either receive discounts or commissions from the selling
stockholders, or they will receive commissions from purchasers of shares. This
compensation may be in excess of customary commission.
The selling stockholders may also sell all or a portion of their shares
under Rule 144 under the Securities Act of 1933 (the "Securities Act"), or may
pledge shares as collateral for margin accounts. These shares could then further
be resold pursuant to the terms of such accounts.
Under certain circumstances, the selling stockholders and any
broker-dealers that participate in the distribution might be deemed to be
"underwriters" within the meaning of the Securities Act and any commission
received by them and any profit on the resale of the shares of common stock as
principal might be deemed to be underwriting discounts and commissions under the
Securities Act. The selling stockholders may agree to indemnify any agent,
dealer or broker-dealer that participates in transactions involving sales of the
shares against certain liabilities, including liabilities arising under the
Securities Act. Liabilities under the federal securities laws cannot be waived.
Because the selling stockholders may be deemed to be "underwriters"
under the Securities Act, the selling stockholders will be subject to prospectus
delivery requirements under the Securities Act. Furthermore, in the event of a
"distribution" of their shares, the selling stockholders, any selling broker or
dealer and any "affiliated purchasers" may be subject to Rule 10b-6 under the
Securities Exchange Act of 1934 (the "Exchange Act") or Regulation M under the
Exchange Act, which prohibits, with certain exceptions, any such person from
bidding for or purchasing any security which is the subject of such distribution
until such person's participation in that distribution is completed. In
addition, Rule 10b-7 under the Exchange Act or Regulation M prohibits any
"stabilizing bid" or "stabilizing purchase" for the purpose of pegging, fixing
or stabilizing the price of the common stock in connection with this offering.
We have informed the selling stockholders that the anti-manipulative provisions
of Regulation M promulgated under the Exchange Act may apply to their sales in
the market.
If we are notified by the selling stockholders that any material
arrangement has been entered into with a broker-dealer for the sale of shares
through a block trade, special offering, exchange distribution or secondary
distribution or a purchase by a broker or dealer, we will file a supplement to
this prospectus, if required, under Rule 424(b) under the Securities Act,
disclosing the following:
13
<PAGE>
o the names of the selling stockholders and of the participating
broker-dealer(s);
o the number of shares involved;
o the price at which such shares were sold;
o the commissions paid or discounts or concessions allowed to such
broker-dealer(s), where applicable;
o that such broker-dealer(s) did not conduct any investigation to
verify the information set out or incorporated by reference in this
prospectus; and
o other facts material to the transaction.
In addition, if we are notified by the selling stockholders that a
donee or pledgee intends to sell more than 500 shares, we will file a supplement
to this prospectus.
The selling stockholders may be entitled under agreements entered into
with us to indemnification from us against liabilities under the Securities Act.
In order to comply with certain state securities laws, if applicable,
these shares of common stock will not be sold in a particular state unless they
have been registered or qualified for sale in that state or any exemption from
registration or qualification is available and complied with.
LEGAL MATTERS
An opinion will be delivered by Blank Rome Comisky & McCauley LLP,
Philadelphia, Pennsylvania, to the effect that the shares of our common stock
being offered by this prospectus have been duly and validly authorized and are
legally issued, fully paid and nonassessable.
EXPERTS
The financial statements incorporated in this prospectus by reference
to the Annual Report on Form 10-KSB for the year ended December 31, 1999, have
been so incorporated in reliance on the report of PricewaterhouseCoopers LLP,
independent accountants, given on the authority of said firm as experts in
auditing and accounting.
DISCLOSURE OF COMMISSION POSITION ON INDEMNIFICATION FOR
SECURITIES ACT LIABILITIES
Our corporation is organized under the laws of the State of Delaware.
Section 145 of the Delaware General Corporation Law (the "DGCL"), in general,
empowers a Delaware corporation to indemnify any person who was or is a party or
is threatened to be made a party to any lawsuit or proceeding (other than an
action by or in the right of that corporation) due to the fact that such person
is or was a director, officer, employee or agent of that corporation, or is or
was serving at the request of that corporation as a director, officer, employee
or agent of another corporation or entity. A corporation is also allowed, in
advance of the final disposition of a lawsuit or proceeding, to pay the expenses
(including attorneys' fees) incurred by any officer, director, employee or agent
in defending the action, as long as the person undertakes to repay this amount
if it is ultimately determined that he or she is not entitled to be indemnified
by the corporation. In addition, Delaware law allows a corporation to indemnify
these persons against expenses (including attorneys' fees), judgments, fines and
amounts paid in settlement actually and reasonably incurred by any of them in
connection with the lawsuit or proceeding if (a) he or she acted in good faith
14
<PAGE>
and in a manner he or she reasonably believed to be in or not opposed to the
best interests of the corporation, and (b) with respect to any criminal action
or proceeding, had no reasonable cause to believe his or her conduct was
unlawful.
A Delaware corporation also can indemnify its officers and directors in
an action by or in the right of the corporation to procure a judgment in its
favor under the same conditions, except that judicial approval is needed to
indemnify any officer or director who is adjudged to be liable to the
corporation. Where an officer or director is successful on the merits or
otherwise in the defense of any such action, the corporation must indemnify him
or her against the expenses (including attorneys' fees) which he or she actually
and reasonably incurred in connection with this action. The indemnification
provided by Delaware law is not deemed to be exclusive of any other rights to
which an officer or director may be entitled under any corporation's own
organizational documents, agreements or otherwise.
As permitted by Section 145 of the DGCL, Section TWELFTH of our
Certificate of Incorporation (our "Certificate") provides that we will indemnify
each person who is or was our director, officer, employee or agent (including
the heirs, executors, administrators or estate of these individuals) or is or
was serving at our request as a director, officer, employee or agent of another
entity, to the fullest extent that the law permits. This indemnification is
exclusive of any other rights to which any of these individuals otherwise may be
entitled. The indemnification also continues after a person ceases to be a
director, officer, employee or agent of our company and inures to the benefit of
the heirs, executors and administrators of these individuals. Expenses
(including attorneys' fees) incurred in defending any lawsuit or proceeding are
also paid by us in advance of the final disposition of these lawsuits or
proceedings after we receive an undertaking from the indemnified person to repay
this amount if it is ultimately determined that he or she is not entitled to be
indemnified by us. Section ELEVENTH of our Certificate further provides that our
directors are not personally liable to us or our stockholders of monetary
damages for breach of fiduciary duty as a director, except for liability (i) for
any breach of his or her duty of loyalty to us or our stockholder, (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 (which deals with
unlawful dividends or stock purchases or redemptions), or (iv) for any
transaction from which he or she derived an improper personal benefit. Our
By-laws also provide that, to the fullest extent permitted by law, we will
indemnify any person who is a party or otherwise involved in any proceeding
because of the fact that he or she is or was a director or officer of our
company or was serving at our request.
Insofar as indemnification for liabilities arising under the Securities
Act of 1933 may be permitted to our directors, officers and controlling persons
pursuant to any of these foregoing provisions, or otherwise, we have been
advised that in the opinion of the Securities and Exchange Commission such
indemnification is against public policy as expressed in the Securities Act and
is therefore unenforceable.
15
<PAGE>
PART II INFORMATION NOT REQUIRED IN PROSPECTUS
Item 14. Other Expenses Of Issuance And Distribution
The following table sets forth the company's estimates (other than of
the SEC registration fee) of the expenses in connection with the issuance and
distribution of the shares of common stock being registered:
SEC registration fee....................... $ 4,475
Legal fees and expenses.................... $ 5,000
Accounting fees and expenses............... $ 1,000
Miscellaneous expenses..................... $ 500
-------
Total: ............................ $10,975
None of these expenses are being paid by the selling stockholders.
Item 15. Indemnification Of Directors And Officers
Section 145 of the Delaware General Corporation Law (the "DGCL")
empowers a Delaware 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 such corporation) by reason of the
fact that such person is or was a director, officer, employee or agent of such
corporation, or is or was serving at the request of such corporation as a
director, officer, employee or agent of another corporation or enterprise. A
corporation may, in advance of the final disposition of any civil, criminal,
administrative or investigative action, suit or proceeding, pay the expenses
(including attorneys' fees) incurred by any officer, director, employee or agent
in defending such action, provided that the director or officer undertakes to
repay such amount if it shall ultimately be determined that he or she is not
entitled to be indemnified by the corporation. A corporation may indemnify such
person against expenses (including attorney's fees), judgments, fines and
amounts paid in settlement actually and reasonably incurred by such person in
connection with such action, suit or proceeding if he or she acting in good
faith and in a manner he or she 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 his or her conduct was
unlawful.
A Delaware corporation may indemnify officers and directors in an
action by or in the right of the corporation to procure a judgment in its favor
under the same conditions, except that no indemnification is permitted without
judicial approval if the officer or director is adjudged to be liable to the
corporation. Where an officer or director is successful on the merits or
otherwise in the defense of any action referred to above, the corporation must
indemnify him or her against the expenses (including attorneys' fees) which he
or she actually and reasonably incurred in connection therewith. The
indemnification provided is not deemed to be exclusive of any other rights to
which an officer or director may be entitled under any corporation's by law,
agreement, vote or otherwise.
In accordance with Section 145 of the DGCL, Section TWELFTH of the
Company's Certificate of Incorporation (the "Certificate") provides that the
Company shall indemnify each person who is or was a director, officer, employee
or agent of the Company (including the heirs, executors, administrators or
estate of such person) or is or was serving at the request of the Company as a
director, officer, employee or agent of another corporation, partnership, joint
venture, trust or other enterprise, to the fullest extent permitted. The
indemnification provided by the Certificate shall not be deemed exclusive of any
other rights to which any of those seeking indemnification or advancement of
II-1
<PAGE>
expenses may be entitled under any by-law, agreement, vote of shareholders or
disinterested directors or otherwise, bot as to action in his official capacity
and as to action in another capacity while holding such office, and shall
continue as to a person who has ceased to be a director, officer, employee or
agent and shall inure to the benefit of the heirs, executors and administrators
of such a person. Expenses (including attorneys' fees) incurred in defending a
civil, criminal, administrative or investigative action, suit or proceeding
shall be paid by the company in advance of the final disposition of such action,
suit or proceeding upon receipt of an undertaking by or on behalf of the
indemnified person to repay such amount if it shall ultimately be determined
that he or she is not entitled to be indemnified by the Company. Section
ELEVENTH of the Certificate provides that a director of the Company shall not be
personally liable to the Company 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 Company 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, or (iv) for any
transaction from which the director derived an improper personal benefit. The
By-laws of the Company provide that, to the fullest extent permitted by
applicable law, the Company shall indemnify any person who is a party or
otherwise involved in any proceeding by reason of the fact that such person is
or was a director or officer of the Company or was serving at the request of the
Company.
Item 16. Exhibits
Exhibit
Number Description of Document
------- -----------------------
4.1 Specimen Certificate of the Company's Common Stock, par value $.01
per share. (1)
5.1 Opinion of Blank Rome Comisky & McCauley LLP.
23.1 Consent of PricewaterhouseCoopers LLP.
24.1 Power of Attorney (included on signature page).
---------------
(1) Incorporated herein by reference to the Registration Statement on Form S-4
(File No. 333-90599).
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;
(ii) To reflect in the prospectus any facts or events arising
after the effective date of the registration statement (or 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 Commission pursuant to Rule 424(b) if, in the aggregate, the
II-2
<PAGE>
changes in volume and price represent no more than a 20 percent 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
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 Section 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.
(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 the offering.
(b) Insofar as indemnification for liabilities arising under the
Securities Act may be permitted to directors, officers and controlling persons
of the registrant pursuant to the provisions described under Item 15 above, or
otherwise, the registrant has been advised that in the opinion of the Securities
and Exchange Commission such indemnification is against 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 expenses incurred or paid by a director, officer or controlling
person of the registrant in the successful defense of 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.
(c) The undersigned registrant hereby undertakes that:
(1) For purposes of determining any liability under the Securities
Act of 1933, the information omitted from the form of prospectus filed as part
of this registration statement in reliance upon Rule 430A and contained in a
form of prospectus filed by the registrant pursuant to Rule 424(b)(1) or (4) or
497(h) under the Securities Act shall be deemed to be part of this registration
statement as of the time it was declared effective by the Securities and
Exchange Commission.
(2) For the purposes of determining any liability under the
Securities Act of 1933, each post-effective amendment that contains a form of
prospectus 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-3
<PAGE>
SIGNATURES AND POWER OF ATTORNEY
Pursuant to the requirements of the Securities Act of 1933, as amended,
the Registrant certifies that it has reasonable grounds to believe that it meets
all the requirements for filing on Form S-3 and has duly caused this
registration statement to be signed on its behalf by the undersigned, thereunto
duly authorized, in the city of Philadelphia, Commonwealth of Pennsylvania on
December 15, 2000.
IMPAX LABORATORIES, INC.
By: /s/ Barry R. Edwards
-----------------------------
Barry R. Edwards,
Co-Chief Executive Officer
KNOW ALL MEN BY THESE PRESENTS, that each person whose signature
appears below constitutes and appoints Barry R. Edwards, his true and lawful
attorney-in-fact and agent with full power of substitution or resubstitution,
for him and in his name, place and stead, in any and all capacities, to sign any
and all amendments to this Registration Statement, and to file the same, with
all exhibits thereto, and other documentation in connection therewith, with the
Securities and Exchange Commission, granting unto said attorneys-in-fact and
agents full power and authority to do and perform each and every act and thing
requisite and necessary to be done in and about the premises, as fully to all
intents and purposes as he might or could do in person, hereby ratifying and
confirming all that said attorneys-in-fact and agents, or their substitute or
substitutes, may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Act of 1933, as amended,
this Registration Statement has been signed by the following persons on December
15, 2000 in the capacities indicated.
<TABLE>
<CAPTION>
Name Title
---- -----
<S> <C>
/s/ Charles Hsiao, Ph.D. Chairman, Co-Chief Executive Officer and Director
------------------------------------
Charles Hsiao, Ph.D.
/s/ Barry R. Edwards Co-Chief Executive Officer and Director
-----------------------------------
Barry R. Edwards
/s/ Larry Hsu, Ph.D. President, Chief Operating Officer and Director
------------------------------------
Larry Hsu, Ph.D.
/s/ David J. Edwards Director
------------------------------------
David J. Edwards
/s/ Nigel Fleming, Ph.D. Director
-----------------------------------
Nigel Fleming, Ph.D.
/s/ Jason Lin Director
------------------------------------------
Jason Lin
/s/ Michael Markbreiter Director
-----------------------------------
Michael Markbreiter
/s/ Oh Kim Sun Director
--------------------------------------
Oh Kim Sun
</TABLE>
II-4
<PAGE>
EXHIBIT INDEX
Exhibit
Number Description of Document
------- -----------------------
4.1 Specimen Certificate of the Company's Common Stock, par
value $0.01 per share.(1)
5.1 Opinion of Blank Rome Comisky & McCauley LLP.
23.1 Consent of PricewaterhouseCoopers LLP.
24.1 Power of Attorney (included on signature page).
---------------------
(1) Incorporated herein by reference to the Registration Statement on Form S-4
(File No. 333-90599).
II-5
