SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
S-8
REGISTRATION
STATEMENT UNDER THE SECURITIES ACT OF 1933
Chembio
Diagnostics, Inc.
(Exact
Name of Registrant as Specified in its Charter)
Nevada
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88-0425691
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(State
or Other Jurisdiction of
Incorporation
or Organization)
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(I.R.S.
Employer
Identification
Number)
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3661
Horseblock Road
Medford,
New York 11763
(631)
924-1135
(Address
of Principal Executive Office, including zip code)
2008
Stock Incentive Plan
(Full
Name of Plan)
Lawrence A.
Siebert
3661
Horseblock Road
Medford,
New York 11763
(631)
924-1135
(Name, address, including zip code,
and telephone number, including area code, of Agent for
Service)
Copy
to:
Alan
Talesnick, Esq.
James
J. Muchmore, Esq.
Patton
Boggs LLP
1660
Lincoln Street, Suite 1900
Denver,
Colorado 80264
(303)
830-1776
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting
company. See the definitions of “large accelerated filer,”
“accelerated filer” and “smaller reporting company” in Rule 12b-2 of the
Exchange Act.
Large
accelerated
filer ( )
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Accelerated
filer ( )
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Non-accelerated
filer ( )
(Do
not check if a smaller reporting company)
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Smaller
reporting company (X)
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CALCULATION
OF REGISTRATION FEE
Title
of Securities to be Registered
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Amount
to be Registered (1)
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Proposed
Maximum Offering Price per Share (2)
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Proposed
Maximum Aggregate Offering Price (2)
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Amount
of Registration Fee (2)
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Common
Stock, par value $.01 per share (3)
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433,650 |
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$ |
0.156 |
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$ |
67,649.40 |
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$ |
2.66 |
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Common
Stock, par value $.01 per share (4)
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4,566,350 |
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$ |
0.156 |
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$ |
712,350.60 |
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$ |
27.99 |
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Total
(5):
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5,000,000 |
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$ |
0.156 |
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$ |
780,000.00 |
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$ |
30.65 |
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(1) Pursuant
to Rule 416 under the Securities Act of 1933, as amended, (the “Securities
Act”) this Registration Statement shall also cover additional shares of
Common Stock that may become issuable by reason of any stock split, stock
dividend, recapitalization or other similar transactions effected without
consideration that results in an increase in the number of the
Registrant’s shares of outstanding Common Stock. In addition, this
Registration Statement covers the resale by certain Selling Stockholders
named in the Prospectus included in and filed with this Form S-8 of
certain of the shares of the Registrant’s Common Stock subject to this
Registration Statement, for which no additional registration fee is
required pursuant to Rule 457(h)(3). In addition, pursuant to Rule
416(c) of the Securities Act, this registration statement also covers an
indeterminate amount of interests to be offered or sold pursuant to the
employee benefit plan(s) described herein.
(2) Solely
for the purpose of calculating the registration fee, the offering price
per share and the aggregate offering price have been calculated pursuant
to Rules 457(c) and 457(h) of the Securities Act of 1933, as amended,
computed on the basis of the market value of the shares of Common Stock on
June 18, 2008 estimated in accordance with Rule 457(c).
(3) Represents
shares underlying outstanding options granted under the 2008 Stock
Incentive Plan.
(4) Represents
shares available for future grants under the 2008 Stock Incentive
Plan.
(5) Represents
total shares underlying options granted, and available for grant, of
5,000,000 under the 2008 Stock Incentive Plan.
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EXPLANATORY
NOTE
This
Registration Statement on Form S-8 (this “Registration Statement”) registers
shares of common stock, par value $0.01 per share, of Chembio Diagnostics, Inc.
(the “Company”), consisting of (i) shares previously issued upon the
exercise of options granted under the Company’s 2008 Stock Incentive Plan (the
“2008 Plan”); (ii) shares that will be issued upon the exercise of options
granted under the 2008 Plan; and (iii) shares available to be issued under the
2008 Plan.
This
Registration Statement contains two parts. First, the materials that
follow Part I of this Registration Statement on Form S-8 (this “Registration
Statement”) up to Part II of this Registration Statement constitute
the reoffer prospectus, prepared in accordance with Part I of Form S-3, in
accordance with General Instruction C of Form S-8 (the
“Prospectus”). The Prospectus permits reoffers and resales of those
shares referred to above that constitute “restricted securities” or “control
securities”, within the meaning of Form S-8, by certain of the Company’s
stockholders, as more fully set forth therein. The second part
contains information required to be set forth in the registration statement
pursuant to Part II of Form S-8.
PART
I
INFORMATION
REQUIRED IN THE SECTION 10(a) PROSPECTUS
The
documents containing the information required by Part I of this Registration
Statement will be sent or given to our employees, officers and directors, as
specified by Rule 428(b)(1) under the Securities Act. Those documents
do not need to be filed with the Securities and Exchange Commission (the
“Commission”) either as part of this Registration Statement or as prospectuses
or prospectus supplements pursuant to Rule 424 under the Securities
Act. These documents and the documents incorporated by reference in
this Registration Statement pursuant to Item 3 of Part II of this Registration
Statement, taken together, constitute a prospectus that meets the requirement of
Section 10(a) of the Securities Act. The Company will provide without
charge to any person, upon written or oral request of such person, a copy of
each document incorporated by reference in Item 3 of Part II of this
Registration Statement (which documents are incorporated by reference in the
Prospectus as set forth in Form S-8), other than exhibits to such documents that
are not specifically incorporated by reference, the other documents required to
be delivered to eligible employees pursuant to Rule 428(b) under the Securities
Act and additional information about the 2008 Plan. Requests should
be directed to the Company’s Secretary at 3661 Horseblock Road, Medford, New
York 11763.
REOFFER
PROSPECTUS
CHEMBIO
DIAGNOSTICS, INC.
433,650
SHARES OF COMMON STOCK
Acquired
or to be Acquired by the Selling Stockholders Under
2008
Stock Incentive Plan
This
reoffer prospectus (this “Prospectus”) relates to an aggregate of up to 433,650
shares (the “Shares”) of common stock, par value $0.01 per share (the “Common
Stock”), of Chembio Diagnostics, Inc., a Nevada corporation (the “Company”),
consisting of 433,650 shares issuable upon exercise of currently outstanding
options, which may be offered and sold from time to time by certain stockholders
of the Company (the “Selling Stockholders”) who have acquired or will acquire
such Shares pursuant to the Company’s 2008 Stock Incentive Plan (the “2008
Plan”). See “Selling Stockholders”.
This
Prospectus covers the offering for resale of (i) shares acquired by the Selling
Stockholders prior to the filing of a Registration Statement on Form S-8 by the
Company; (ii) shares to be acquired by the Selling Stockholders upon an exercise
of currently outstanding options ((i) and (ii) collectively referred to as the
“Restricted Shares”); and (iii) shares to be acquired by Selling
Stockholders who may be deemed affiliates of the Company after the filing of a
Registration Statement on Form S-8 pursuant to options currently held by those
Selling Stockholders (“Control Shares”).
Shares
acquired pursuant to the 2008 Plan prior to the effective date of a registration
statement covering securities issued under the 2008 Plan are “restricted
securities” pursuant to Rule 144, whether or not held by affiliates of the
Company. This Prospectus has been prepared for the purpose of
registering the shares under the Securities Act to allow for future sales by the
Selling Stockholders, on a continuous or delayed basis, to the public without
restriction. The Selling Stockholders may offer for their own account
these Shares for resale from time to time.
The
Selling Stockholders may sell the Shares covered by this Prospectus through
various means, including directly or indirectly to purchasers, in one or more
transactions on any stock market on which the Shares are traded at the time of
sale, in privately negotiated transactions, or through a combination of these
methods. Each Selling Stockholder that sells any Shares pursuant to
this Prospectus may be deemed to be an “underwriter” within the meaning of the
Securities Act of 1933, as amended (the “Securities Act”). Any
commissions received by a broker or dealer in connection with resales of shares
may be deemed to be underwriting commissions or discounts under the Securities
Act. For additional information on the Selling Stockholders’ possible
methods of sale, you should refer to the section in this Prospectus entitled
“Plan of Distribution.”
We will
not receive any proceeds from the sale of the Shares being offered by the
Selling Stockholders. We will pay all of the expenses associated with
this Prospectus. Brokerage commissions and similar selling expenses,
if any, attributable to the offer or sale of the Shares will be borne by the
Selling Stockholder.
Our
Common Stock is quoted on the OTC Bulletin Board under the symbol
“CEMI.” On June 18, 2008, the closing bid price of our Common Stock
on such market was $0.156 per share.
This
investment involves a high degree of risk. Please see “Risk Factors” beginning
on page 3 of this Prospectus.
Neither
the Securities and Exchange Commission nor any state securities commission has
approved or disapproved of these securities or determined whether this
Prospectus is truthful or complete. Any representation to the
contrary is a criminal offense.
The date
of this Prospectus is June 19, 2008.
TABLE OF
CONTENTS
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Page
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WHERE
YOU CAN FIND ADDITIONAL INFORMATION
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1
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SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS
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1
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SUMMARY
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2
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RISK
FACTORS
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3
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USE
OF PROCEEDS
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10
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SELLING
STOCKHOLDERS
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10
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PLAN
OF DISTRIBUTION
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11
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EXPERTS
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13
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LEGAL
MATTERS
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13
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INCORPORATION
OF CERTAIN INFORMATION BY REFERENCE
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13
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Disclosure
of Commission Position of Indemnification for Securities Act
Liabilities
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14
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You
should only 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 Common Stock is not
being offered 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 this
Prospectus.
WHERE
YOU CAN FIND ADDITIONAL INFORMATION
The
Company is subject to the information requirements of the Securities Exchange
Act of 1934, as amended (the “Exchange Act”), and, in accordance therewith,
files reports, proxy statements and other information with the Securities and
Exchange Commission (the “Commission”). The reports, proxy statements
and other information filed by the Company with the Commission can be inspected
and copied at the Public Reference Room of the Commission at 100 F Street, N.E.,
Washington, D.C. 20549. Copies of such material also may be obtained
by mail from the Public Reference Room of the Commission, 100 F Street, N.E.,
Washington, D.C. 20549, at prescribed rates. Information regarding
the operation of the Public Reference Room may be obtained by calling the
Commission at 1-800-SEC-0330. Additionally, the Commission maintains
an Internet site that contains reports, proxy and information statements and
other information regarding registrants that file electronically with the
Commission and that is located at http://www.sec.gov.
This
Prospectus constitutes part of a Registration Statement on Form S-8 filed on the
date hereof (herein, together with all amendments and exhibits, referred to as
the “Registration Statement”) by the Company with the Commission under the
Securities Act. This Prospectus does not contain all of the
information set forth in the Registration Statement, certain parts of which are
omitted in accordance with the rules and regulations of the
Commission. For further information with respect to the Company and
the Common Stock, reference is hereby made to the Registration
Statement. Statements contained herein concerning the provisions of
any contract, agreement or other document are not necessarily complete, and in
each instance reference is made to the copy of such contract, agreement or other
document filed as an exhibit to the Registration Statement or otherwise filed
with the Commission. Each such statement is qualified in its entirety
by such reference. Copies of the Registration Statement together with
exhibits may be inspected at the offices of the Commission as indicated above
without charge and copies thereof may be obtained therefrom upon payment of a
prescribed fee.
SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
Prospectus contains forward-looking statements that may be affected by matters
outside our control that could cause materially different results.
Some of
the information in this Prospectus contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933. These
statements express, or are based on, our expectations about future
events. Forward-looking statements give our current expectations or
forecasts of future events. Forward-looking statements generally can
be identified by the use of forward-looking terminology, such as, “may,” “will,”
“expect,” “intend,” “project,” “estimate,” “anticipate,” “believe” or “continue”
or the negative thereof or similar terminology. They include
statements regarding our:
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amount,
nature and timing of capital
expenditures;
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operating
costs and other expenses; and
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cash
flow and anticipated liquidity.
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Although
we believe the expectations and forecasts reflected in these and other
forward-looking statements are reasonable, we can give no assurance they will
prove to have been correct. They can be affected by inaccurate
assumptions or by known or unknown risks and uncertainties. Factors
that could cause actual results to differ materially from expected results are
described under “Risk Factors” and include:
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general
economic conditions;
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currency
exchange volatility;
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the
risks associated with acquiring and integrating new
businesses;
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our
ability to generate sufficient cash flows to
operate;
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availability
of capital;
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the
strength and financial resources of our
competitors;
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regulatory
risks and developments;
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our
ability to find and retain skilled personnel;
and
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the
lack of liquidity of our Common
Stock.
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Any of
the factors listed above and other factors contained in this Prospectus could
cause our actual results to differ materially from the results implied by these
or any other forward-looking statements made by us or on our
behalf. We cannot assure you that our future results will meet our
expectations.
When you
consider these forward-looking statements, you should keep in mind these risk
factors and the other cautionary statements in this Prospectus. Our
forward-looking statements speak only as of the date made.
SUMMARY
The
following summary is qualified in its entirety by the more detailed information
and the financial statements and notes thereto appearing elsewhere in, or
incorporated by reference into, this Prospectus. Consequently, this
summary does not contain all of the information that you should consider before
investing in our Common Stock. You should carefully read the entire
Prospectus, including the “Risk Factors” section, and the documents and
information incorporated by reference into this Prospectus before making an
investment decision.
This
Prospectus relates to 433,650 shares of our Common Stock, consisting of 433,650
shares issuable upon exercise of currently outstanding options, which may be
offered for sale from time to time by the Selling Stockholders identified in
this Prospectus. We anticipate that the Selling Stockholders will
offer the Shares for sale at prevailing market prices on the OTC Bulletin Board
on the date of such sale. We will not receive any proceeds from these
sales. We are paying the expenses incurred in registering the Shares,
but all selling and other expenses incurred by each of the Selling Stockholders
will be borne by such Selling Stockholder.
Chembio
Diagnostics, Inc.
Our
Corporate Information
Chembio
Diagnostic Systems Inc. was formed in 1985. Since inception we have
been involved in developing, manufacturing, selling and distributing medical
diagnostic tests, including rapid tests that detect a number of infectious
diseases. On May 5, 2004, Chembio Diagnostic Systems Inc.
completed a merger through which it became a wholly-owned subsidiary of Chembio
Diagnostics, Inc., formerly known as Trading Solutions.com, Inc. (“Chembio” or
the “Company”). As a result of this transaction, the management and
business of Chembio Diagnostic Systems Inc. became the management and business
of the Company. Our principal executive offices are located at 3661
Horseblock Road, Medford, New York 11763. Our telephone number is
(631) 924-1135. Our website address is
www.chembio.com.
Our
Business
We are a
developer, manufacturer and marketer of rapid diagnostic tests that detect
infectious diseases. Our main products presently commercially
available are three rapid tests for the detection of HIV antibodies in whole
blood, serum and plasma samples, two of which were approved by the FDA last
year. These products employ single path lateral flow technology which
we have licensed from Inverness Medical Innovations, Inc. (“Inverness”), who is
also our exclusive marketing partner for those two products in the United States
under its Clearview® brand. Inverness launched its marketing of these
products in the United States in February, 2007. Chembio’s two HIV
STAT-PAK® rapid HIV tests are marketed outside the United States through
different partners and channels under a license from Inverness. We
also have a rapid test for Chagas disease (a parasitic disease endemic in Latin
America) as well as a line of rapid tests for tuberculosis, including tests for
tuberculosis in animals for which USDA approval for certain tests has been
received.
On
March 13, 2007 we were issued United States patent # 7,189,522 for our
Dual Path Platform (“DPP™”) rapid test system. We believe that as a
result of the patent protection we now have with DPP™, we have a significant
opportunity to develop and license many new rapid tests in a number of fields
including but not limited to infectious diseases. We have already
completed initial development on some products in this new
platform. We believe the DPP™ provides significant advantages over
standard single path lateral flow assays, and we are developing most of our new
products using this platform.
Our
products are sold to medical laboratories and hospitals, governmental and public
health entities, non-governmental organizations, medical professionals and
retail establishments. Our products are sold either under our
STAT-PAK® or SURE CHECK® registered trademarks and/or the private labels of our
marketing partners, such as the Inverness Clearview® label.
We have a
history of losses, and we continue to incur operating and net
losses. We have non-exclusive licenses to lateral flow patents held
by Inverness and Abbott Laboratories, Inc., and to reagents including those that
are used in our HIV rapid tests. These licenses do not necessarily
insulate us from patent challenges by other patent holders. We have
filed applications for two lateral flow patents that incorporate features that
we believe may further protect us from patent challenges.
Our main
products are as follows:
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HIV
Rapid Tests: HIV 1/2 STAT-PAK® Cassette, HIV 1/2 SURE CHECK® and HIV 1/2
STAT-PAK® Dipstick;
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·
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Chagas
Rapid Test: Chagas STAT-PAK; and
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·
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Tuberculosis
(TB): Prima TB STAT-PAK and Veterinary
products.
|
We also
are in the process of developing rapid tests employing our patented DPP™
technology including, but not limited to, an oral fluid rapid HIV
test.
We
manufacture all of the products we sell. All of these products, as
well as those that are under development, employ various formats of lateral flow
technology. Lateral flow, whether single or dual path, generally
refers to the process of a sample flowing from the point of application on a
test strip to provide a test result on a portion of a strip downstream from
either the point of application of the sample or of another
reagent. We believe we have expertise and proprietary know-how in the
field of lateral flow technology.
Our
principal executive offices are located at 3661 Horseblock Road, Medford, New
York 11763. Our telephone number is (631) 924-1135. Our
website address is www.chembio.com.
RISK
FACTORS
You
should carefully consider each of the following risk factors and all of the
other information provided in this Prospectus before purchasing our Common
Stock. The risks described below are those we currently believe may
materially affect us. An investment in our Common Stock involves a
high degree of risk, and should be considered only by persons who can afford the
loss of their entire investment.
Risks
related to our industry, business and strategy
Because
we may not be able to obtain necessary regulatory approvals for some of our
products, we may not generate revenues in the amounts we expect, or in the
amounts necessary to continue our business.
All of
our proposed and existing products are subject to regulation in the U.S. by the
U.S. Food and Drug Administration, the U.S. Department of Agriculture and/or
other domestic and international governmental, public health agencies,
regulatory bodies or non-governmental organizations. In particular,
we are subject to strict governmental controls on the development, manufacture,
labeling, distribution and marketing of our products. The process of
obtaining required approvals or clearances varies according to the nature of,
and uses for, a specific product. These processes can involve lengthy
and detailed laboratory testing, human or animal clinical trials, sampling
activities, and other costly, time-consuming procedures. The
submission of an application to a regulatory authority does not guarantee that
the authority will grant an approval or clearance for product. Each
authority may impose its own requirements and can delay or refuse to grant
approval or clearance, even though a product has been approved in another
country.
The time
taken to obtain approval or clearance varies depending on the nature of the
application and may result in the passage of a significant period of time from
the date of submission of the application. Delays in the approval or
clearance processes increase the risk that we will not succeed in introducing or
selling the subject products, and we may determine to devote our resources to
different products.
Changes
in government regulations could increase our costs and could require us to
undergo additional trials or procedures, or could make it impractical or
impossible for us to market our products for certain uses, in certain markets,
or at all.
Changes
in government regulations may adversely affect our financial condition and
results of operations because we may have to incur additional expenses if we are
required to change or implement new testing, manufacturing and control
procedures. If we are required to devote resources to develop such
new procedures, we may not have sufficient resources to devote to research and
development, marketing, or other activities that are critical to our
business.
For
example, the European Union and other jurisdictions have recently established a
requirement that diagnostic medical devices used to test human biological
specimens must receive regulatory approval known as a CE mark, or be registered
under the ISO 13.485 medical device directive. The letters “CE” are
the abbreviation of the French phrase “Conforme Européene,” which means
“European conformity.” ISO (“International Organization for
Standardization”) is the world’s largest developer of standards with 148 member
countries. As such, export to the European and other jurisdictions
without the CE or ISO 13.485 mark is not possible. Although we are
not currently selling products to countries requiring CE marking, we expect that
we will do so in the near future in order to grow our business. While
we have recently received ISO 13.485 certification, there are no assurances that
we will be able to maintain this certification, in addition we are in the
process of implementing quality and documentary procedures in order to obtain CE
registration, and we are not aware of any material reason why such approval will
not be granted. However, if for any reason a CE registration is not
granted, our ability to export our products could be adversely
impacted.
We can
manufacture and sell our products only if we comply with regulations of
government agencies such as the FDA and USDA. We have implemented a
quality system that is intended to comply with applicable
regulations. Although FDA approval is not required for the export of
our products, there are export regulations promulgated by the FDA that
specifically relate to the export of our products. Although we
believe that we meet the regulatory standards required for the export of our
products, these regulations could change in a manner that could adversely impact
our ability to export our products.
Our
products may not be able to compete with new diagnostic products or existing
products developed by well-established competitors, which would negatively
affect our business.
The
diagnostic industry is focused on the testing of biological specimens in a
laboratory or at the point-of-care and is highly competitive and rapidly
changing. Our principal competitors often have considerably greater
financial, technical and marketing resources than we do. Several
companies produce diagnostic tests that compete directly with our testing
product line, including but not limited to, Orasure Technologies, Inverness
Medical and Trinity Biotech. As new products enter the market, our
products may become obsolete or a competitor’s products may be more effective or
more effectively marketed and sold than ours. Although we have no
specific knowledge of any competitor’s product that will render our products
obsolete, if we fail to maintain and enhance our competitive position or fail to
introduce new products and product features, our customers may decide to use
products developed by our competitors, which could result in a loss of revenues
and cash flow.
We are
developing an oral fluid rapid HIV test as well as other applications utilizing
our Dual Path Platform™ technology, which we believe could enhance our
competitive position in HIV rapid testing and other fields. However,
we have not completed development of any DPP™ product, and we still have
technical, manufacturing, regulatory and marketing challenges to meet before we
will know whether we can successful commercialize products incorporating this
technology. There can be no assurance that we will overcome these
challenges.
We have
granted Inverness exclusive rights to market our SURE CHECK® HIV 1/2 globally
and our HIV 1/2 STAT PAK® in the U.S. Inverness has no rapid HIV
tests that are approved for marketing in the U.S., we are not aware of any rapid
HIV products that Inverness is even contemplating for the U.S., and Inverness is
obligated to inform us of any such products as soon as it is able to do
so. Inverness does have rapid HIV tests manufactured by certain of
its subsidiaries outside the U.S. that are being actively marketed outside the
U.S., primarily in developing countries. Our HIV 1/2 STAT PAK
cassette and dipstick products compete against these Inverness Products, and we
specifically acknowledge in our agreements with Inverness the existence of such
other products. Moreover, except for a product in the HIV barrel
field as defined in our agreement with Inverness, Inverness is permitted under
our agreements to market certain types of permitted competing rapid HIV tests in
the U.S. Under these conditions, we could choose to terminate the
applicable agreement with Inverness or change the agreement to a non-exclusive
agreement, and Inverness would expand the lateral flow license granted to the
Company to allow the Company to market the product independently or through
other marketing partners. While we believe that Inverness is
committed to successfully marketing our products particularly in the U.S. and
other developed countries where our products are or become approved for
marketing, Inverness may choose to develop or acquire competing products for
marketing in the U.S. as well as other markets where they are marketing our SURE
CHECK® HIV 1/2 product, and such an action could have at least a temporary
material adverse effect on the marketing of these products until such time as
alternative marketing arrangements could be implemented. While we
also believe that the expansion of our license to the Inverness lateral flow
patents substantially facilitates our ability to make alternative marketing
arrangements, there can be no assurance that the modification of marketing
arrangements and the possible corresponding delays or suspension of sales would
not have a material adverse effect on our business.
In
addition, the point-of-care diagnostics industry is undergoing rapid
technological changes, with frequent introductions of new technology-driven
products and services. As new technologies become introduced into the
point-of-care diagnostic testing market, we may be required to commit
considerable additional efforts, time and resources to enhance our current
product portfolio or develop new products. We may not have the
available time and resources to accomplish this and many of our competitors have
substantially greater financial and other resources to invest in technological
improvements. We may not be able to effectively implement new
technology-driven products and services or be successful in marketing these
products and services to our customers, which would materially harm our
operating results.
We own no
issued patents covering single path lateral flow technology, and the field of
lateral flow technology is complex and characterized by a substantial amount of
litigation, so the risk of potential patent challenges is ongoing for us in
spite of our pending patent applications.
Although
we have been granted non-exclusive licenses to lateral flow patents owned by
Inverness Medical Innovations, Inc. and Abbott Laboratories, Inc., there is no
assurance that their lateral flow patents will not be challenged or that
licenses from other parties may not be required, if available at
all. In the event that it is determined that a license is required
and it is not possible to negotiate a license agreement under a necessary
patent, we may be able to modify our HIV rapid test products and other products
such that a license would not be necessary. However, this alternative
could delay or limit our ability to sell these products in the U.S. and other
markets, which would adversely affect our results of operations, cash flows and
business.
On
March 13, 2007 our Dual Path Platform Immunassay Device patent application
was issued as United States patent no. 7,189,522. Additional
protection for this intellectual property is pending worldwide. This
platform has shown improved sensitivity as compared with conventional platforms
in a number of preliminary studies using well characterized HIV, tuberculosis
and other samples. We believe that this new lateral flow platform is
outside of the scope of currently issued patents in the field of lateral flow
technology, thereby offering the possibility of a greater freedom to
operate. However there can be no assurance that our patents or our
products incorporating the patent claims will not be challenged at some time in
the future.
New
developments in health treatments or new non-diagnostic products may reduce or
eliminate the demand for our products.
The
development and commercialization of products outside of the diagnostics
industry could adversely affect sales of our product. For example,
the development of a safe and effective vaccine to HIV or treatments for other
diseases or conditions that our products are designed to detect, could reduce,
or eventually eliminate, the demand for our HIV or other diagnostic products and
result in a loss of revenues.
We
may not have sufficient resources to effectively introduce and market our
products, which could materially harm our operating results.
Introducing
and achieving market acceptance for our rapid HIV tests and other new products
will require substantial marketing efforts and will require us or our contract
partners to make significant expenditures. In the U.S. and other
developed world markets where we will begin to market our FDA-approved products
through Inverness and through other partners, we have no history upon which to
base market or customer acceptance of these products. In some
instances we will be totally reliant on the marketing efforts and expenditures
of our contract partners. If they do not have or commit the expertise
and resources to effectively market the products that we manufacture, our
operating results will be materially harmed.
The
success of our business depends, in addition to the market success of our
products, on our ability to raise additional capital through the sale of debt or
equity or through borrowing, and we may not be able to raise capital or borrow
funds in amounts necessary to continue our business, or at all.
Although
our revenues and gross margins increased significantly in recent periods, we
sustained significant operating losses in 2007, 2006 and 2005. At
December 31, 2007, we had a stockholders’ equity of $4.2 million and a working
capital surplus of $3.2 million. Our liquidity and cash requirements
will depend on several factors. These factors include: (1)
the level of revenue growth; (2) the extent to which, if any, that revenue
growth improves operating cash flows; (3) our investments in research and
development, facilities, marketing, regulatory approvals and other investments
we may determine to make; and (4) our investment in capital equipment and the
extent to which this investment improves cash flow through operating
efficiencies. If our resources are not sufficient to fund our needs
through 2008, there are no assurances that we will be successful in raising
sufficient capital.
On
December 19, 2007, we received $1.1 million pursuant to the exercise of certain
warrants. In spite of this capital raise, there is no guarantee that
the Company will be successful in raising additional capital if
needed.
Our
objective of increasing international sales is critical to our business plan and
if we fail to meet this objective, we may not generate revenues in the amounts
we expect, or in amounts necessary to continue our business.
We intend
to attempt to increase international sales of our products. A number
of factors can slow or prevent international sales, or substantially increase
the cost of international sales, including:
·
|
regulatory
requirements and customs
regulations;
|
·
|
cultural
and political differences;
|
·
|
foreign
exchange rates, currency fluctuations and
tariffs;
|
·
|
dependence
on and difficulties in managing international distributors or
representatives;
|
·
|
the
creditworthiness of foreign
entities;
|
·
|
difficulties
in foreign accounts receivable collection;
and
|
·
|
economic
conditions and the absence of available funding
sources.
|
If we are
unable to increase our revenues from international sales, our operating results
will be materially harmed.
We
rely on trade secret laws and agreements with our key employees and other third
parties to protect our proprietary rights, and we cannot be sure that these laws
or agreements adequately protect our rights.
We
believe that factors such as the technological and creative skills of our
personnel, strategic relationships, new product developments, frequent product
enhancements and name recognition are essential to our success. All
our management personnel are bound by non-disclosure agreements. If
personnel leave our employment, in some cases we would be required to protect
our intellectual property rights pursuant to common law theories which may be
less protective than provisions of employment, non-competition or non-disclosure
agreements.
We seek
to protect our proprietary products under trade secret and copyright laws, enter
into license agreements for various materials and methods employed in our
products, and enter into strategic relationships for distribution of the
products. These strategies afford only limited
protection. We currently have no foreign patents, although we have
several license agreements for reagents. Our SURE CHECK trademark has
been registered in the U.S.
Despite
our efforts to protect our proprietary rights, unauthorized parties may attempt
to copy aspects of our products or to obtain information that we regard as
proprietary. We may be required to expend substantial resources in
asserting or protecting our intellectual property rights, or in defending suits
related to intellectual property rights. Disputes regarding
intellectual property rights could substantially delay product development or
commercialization activities because some of our available funds would be
diverted away from our business activities. Disputes regarding
intellectual property rights might include state, federal or foreign court
litigation as well as patent interference, patent reexamination, patent reissue,
or trademark opposition proceedings in the U.S. Patent and Trademark
Office.
To
facilitate development and commercialization of a proprietary technology base,
we may need to obtain additional licenses to patents or other proprietary rights
from other parties. Obtaining and maintaining these licenses, which
may not be available, may require the payment of up-front fees and
royalties. In addition, if we are unable to obtain these types of
licenses, our product development and commercialization efforts may be delayed
or precluded.
Our
continued growth depends on retaining our current key employees and attracting
additional qualified personnel, and we may not be able to do so.
Our
success will depend to a large extent upon the skills and experience of our
executive officers, management and sales, marketing, operations and scientific
staff. Although we have not experienced unusual retention and/or
recruitment problems to date, we may not be able to attract or retain qualified
employees in the future due to the intense competition for qualified personnel
among medical products businesses.
If we are
not able to attract and retain the necessary personnel to accomplish our
business objectives, we may experience constraints that will adversely affect
our ability to effectively manufacture, sell and market our products to meet the
demands of our strategic partners in a timely fashion, or to support internal
research and development programs. Although we believe we will be
successful in attracting and retaining qualified personnel, competition for
experienced scientists and other personnel from numerous companies and academic
and other research institutions may limit our ability to do so on acceptable
terms.
We have
entered into employment contracts with our President, Lawrence Siebert, and our
Senior Vice President of Research and Development, Javan
Esfandiari. Due to the specific knowledge and experience of these
executives regarding the industry, technology and market, the loss of the
services of either one of them would likely have a material adverse effect on
the Company. The contract with Mr. Siebert has a term scheduled to
end in May 2009, and the contract with Mr. Esfandiari has a term of three
years ending March 2010. We have obtained a key man insurance
policy for Mr. Esfandiari.
We
believe our success depends on our ability to participate in large government
programs in the U.S. and worldwide and we may not be able to do so.
We
believe it to be in our best interests to meaningfully participate in the
Presidential Emergency Plan for Aids Relief Program, UN Global Fund initiatives
and other programs funded by large donors. We have initiated several
strategies to participate in these programs. Participation in these
programs requires alignment with the many other participants in these programs
including the World Health Organization, U.S. Center for Disease Control, U.S.
Agency for International Development, non-governmental organizations, and HIV
service organizations. If we are unsuccessful in our efforts to
participate in these programs, our operating results could be materially
harmed.
We
have a history of incurring net losses and we cannot be certain that we will be
able to achieve profitability.
Since the
inception of Chembio Diagnostic Systems, Inc. in 1985 and through the period
ended December 31, 2007, we have incurred net losses. As of
December 31, 2007, we have an accumulated deficit of $35
million. We incurred net losses of $2.6 million and $5 million in
2007 and 2006, respectively.
We expect
to continue to make substantial expenditures for sales and marketing, regulatory
submissions, product development and other purposes. Our ability to
achieve profitability in the future will primarily depend on our ability to
increase sales of our products, reduce production and other costs and
successfully introduce new products and enhanced versions of our existing
products into the marketplace. If we are unable to increase our
revenues at a rate that is sufficient to achieve profitability, our operating
results would be materially harmed.
To
the extent that we are unable to obtain sufficient product liability insurance
or that we incur product liability exposure that is not covered by our product
liability insurance, our operating results could be materially
harmed.
We may be
held liable if any of our products, or any product which is made with the use or
incorporation of any of the technologies belonging to us, causes injury of any
type or is found otherwise unsuitable during product testing, manufacturing,
marketing, sale or usage. Although we have obtained product liability
insurance, this insurance may not fully cover our potential
liabilities. In addition, as we attempt to bring new products to
market, we may need to increase our product liability coverage which would be a
significant additional expense that we may not be able to afford. If
we are unable to obtain sufficient insurance coverage at an acceptable cost to
protect us, we may be forced to abandon efforts to commercialize our products or
those of our strategic partners, which would reduce our revenues.
Risks
related to our Common Stock
Until
recently, our Common Stock was classified as penny stock, and it continues to be
extremely illiquid, so investors may not be able to sell as much stock as they
want at prevailing market prices.
Until
recently, our Common Stock was classified as penny stock. Penny
stocks generally are equity securities with a price of less than $5.00 and trade
on the over-the-counter market. As a result, an investor may find it
more difficult to dispose of or obtain accurate quotations as to the price of
the securities that are classified as penny stocks. The “penny stock”
rules adopted by the Commission under the Securities Exchange Act of 1934, as
amended (the “Exchange Act”), subject the sale of the shares of penny stock
issuers to regulations that impose sales practice requirements on
broker-dealers, causing many broker-dealers to not trade penny stocks or to only
offer the stocks to sophisticated investors that meet specified net worth or net
income criteria identified by the Commission. These regulations
contribute to the lack of liquidity of penny stocks.
At the
present time, transactions in our Common Stock are not subject to the “penny
stock” rules because our average revenue for 2005, 2006 and 2007 exceeded $6
million per year. However, there can be no assurance that
transactions in our Common Stock will not be subject to the “penny stock” rules
in the future.
The
average daily trading volume of our Common Stock on the over-the-counter market
was less than 100,000 shares per day over the three months ended June 18,
2008. If limited trading in our stock continues, it may be difficult
for investors to sell their shares in the public market at any given time at
prevailing prices.
Sales
of a substantial number of shares of our Common Stock into the public market by
the selling stockholders, as well as the exercise of our outstanding warrants on
a cash or a cashless basis, may result in significant downward pressure on the
price of our Common Stock and could affect the ability of our stockholders to
realize the current trading price of our Common Stock.
At the
time that this Prospectus is filed with the SEC, a significant number of shares
of our Common Stock will be eligible to be immediately sold in the
market. In addition, pursuant to the December 2007 plan (the “Plan”)
to simplify our capital structure, certain holders of warrants and options
(collectively, the “Non-Employee Warrants”) not including options or warrants
issued to employees or directors in their capacity as such may exercise their
warrants on a cashless basis. Certain Non-Employee Warrant holders
are now permitted to exercise 9,323,855 warrants on a cashless basis at an
exercise price of $0.45 per share at any time on or before June 30,
2008.
The
Plan’s cashless exercise provision permits Non-Employee Warrant holders to use
any excess of the market price of the Company’s Common Stock over the exercise
price of a Non-Employee Warrant as part of the exercise price for another
warrant by submitting both warrants at the time of exercise. Pursuant
to the Plan, certain Non-Employee Warrant holders are permitted on or before
June 30, 2008 to use the greater of (i) $0.53 or (ii) the VWAP for the
ten-trading day period that ends on the second trading day before the exercise
date as the value of the Common Stock, so that each Non-Employee Warrant used as
part of the exercise price payment will represent the difference between the
greater of these two values and the applicable exercise
price.
As of
June 18, 2008, our Common Stock was trading at $0.156 cents per
share. If a large number of Non-Employee Warrant holders exercise
their warrants on a cashless basis on or before June 30, 2008, our stock price
could drop. Even a perception by the market that selling stockholders
may sell in large amounts after the Prospectus is filed with the SEC could place
significant downward pressure on our stock price.
You
will experience substantial dilution upon the exercise warrants underlying
common stock that we are currently registering.
There are
433,650 shares of common stock underlying warrants registered in this
registration statement, 4,124,940 shares of common stock underlying warrants
registered in another registration statement, and 13,098,674 shares of common
stock underlying warrants and options registered in another registration
statement. The securities in the previous registration statements
were issued by the Company in connection with the Company’s previously completed
private placements, and as adjusted in connection with the Company’s December
2007 plan to simplify its capital structure. As of June 18, 2008, we
have approximately 22 million warrants and options outstanding. As a
result, the exercise of the outstanding warrants and options will result in
substantial dilution to the holders of our Common Stock.
Our
management and larger stockholders exercise significant control over our Company
and may approve or take actions that may be adverse to your
interests.
As of
June 18, 2008, our named executive officers, directors and 5% stockholders
beneficially owned approximately 67% of our voting power. For the
foreseeable future, to the extent that our current stockholders vote similarly,
they will be able to exercise control over many matters requiring approval by
the board of directors or our stockholders. As a result, they will be
able to:
·
|
control
the composition of our board of
directors;
|
·
|
control
our management and policies;
|
·
|
determine
the outcome of significant corporate transactions, including changes in
control that may be beneficial to stockholders;
and
|
·
|
act
in each of their own interests, which may conflict with, or be different
from, the interests of each other or the interests of the other
stockholders.
|
USE
OF PROCEEDS
We will
not receive any of the proceeds from the sale of the Shares by the Selling
Stockholders. The Selling Stockholders will pay any underwriting
discounts, commissions and expenses for brokerage, or any other expenses they
incur in disposing of the Shares. We will bear all other costs, fees and
expenses incurred in effecting the registration of the Shares covered by this
Prospectus.
SELLING
STOCKHOLDERS
This
Prospectus relates to Shares that are being registered for reoffers and resales
by Selling Stockholders who have acquired (or, in some cases, may acquire)
Shares pursuant to the 2008 Plan. Non-affiliates holding less than 1,000
Restricted Shares issued under the 2008 Plan and who are not named below may use
this Prospectus for the offer or sale of those Shares.
Beneficial
ownership is determined in accordance with the rules of the Commission, is based
upon 60,537,534 shares outstanding as of June 18, 2008, and generally includes
voting or investment power with respect to securities. Options to purchase
shares of Common Stock that are currently exercisable or exercisable within 60
days of June 18, 2008 are deemed to be outstanding and to be beneficially owned
by the person holding such options for the purpose of computing the percentage
ownership of such person but are not treated as outstanding for the purpose of
computing the percentage ownership of any other person. Information regarding
the Selling Stockholders, including the number of Shares offered for sale, will
be set forth in a prospectus supplement to the extent required. Of the 433,650
shares listed below covered by this Prospectus, 433,650 shares are shares to be
issued upon exercise of outstanding options issued pursuant to the 2008 Plan,
and are being registered for reoffers and resales by the Selling Stockholders
named in the table below. The Selling Stockholders may resell all, a portion, or
none of the Shares from time to time. Certain unnamed non-affiliates,
each of whom may sell up to 1,000 shares of common stock issuable upon the
exercise of options granted by the 2008 Plan, may use this Prospectus for
reoffers and resales.
The
address of each stockholder listed below is care of Chembio Diagnostics, Inc.,
3661 Horseblock Road, Medford, New York 11763. The following table
sets forth the name and relationship to the Company of each Selling Stockholder
and: (1) the number of shares of Common Stock which each Selling Stockholder
beneficially owned as of June 18, 2008; (2) the number of shares of Common Stock
which each Selling Stockholder may offer pursuant to this Reoffer Prospectus;
and (3) (if one percent or more) the percentage of the class to be beneficially
owned by such stockholder assuming the sale of all shares offered pursuant to
this Prospectus.
Selling
Stockholder
|
|
Position
|
|
Shares
Beneficially Owned
|
|
Shares
Covered Under this Prospectus
|
|
Beneficially
Owned After the Resale
|
Davis,
Katherine L.
|
|
Director
|
|
75,650
|
|
3,650
|
|
-
|
Merselis,
James D.
|
|
Director
|
|
45,000
|
|
180,000
|
|
-
|
Siebert,
Lawrence A.
|
|
President
|
|
8,716,405
|
|
250,000
|
|
13.78%
|
|
|
|
|
|
|
|
|
|
TOTALS
|
|
|
|
8,837,055
|
|
433,650
|
|
|
PLAN
OF DISTRIBUTION
The
Shares covered by this Prospectus are being registered by us for the account of
the Selling Stockholders.
The
Shares offered by this Prospectus may be sold from time to time directly by or
on behalf of the Selling Stockholders in one or more transactions on the OTC
Bulletin Board or on any stock exchange on which the Common Stock may be listed
at the time of sale, in privately negotiated transactions, or through a
combination of these methods. The Selling Stockholders may sell Shares through
one or more agents, brokers or dealers or directly to purchasers. These brokers
or dealers may receive compensation in the form of commissions, discounts or
concessions from the Selling Stockholders and/or purchasers of the Shares, or
both. Compensation as to a particular broker or dealer may be in excess of
customary commissions. The Selling Stockholders will act independently of us in
making decisions with respect to the timing, manner and size of each sale or
non-sale related transfer. If a Selling Stockholder is an employee, officer or
director of the Company, he or she will be subject to the Company’s policies
concerning trading and other transactions in the Company’s
securities.
Each
Selling Stockholder of the Shares and any of their pledgees, assignees and
successors-in-interest may, from time to time, sell any or all of their Shares
on any stock exchange, market or trading facility on which the shares are traded
or in private transactions. These sales may be at fixed or negotiated
prices. A Selling Stockholder may use any one or more of the
following methods when selling the Shares:
·
|
ordinary
brokerage transactions and transactions in which the broker-dealer
solicits purchasers;
|
·
|
block
trades in which the broker-dealer will attempt to sell the shares as agent
but may position and resell a portion of the block as principal to
facilitate the transaction;
|
·
|
purchases
by a broker-dealer as principal and resale by the broker-dealer for its
account;
|
·
|
an
exchange distribution in accordance with the rules of the applicable
exchange;
|
·
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privately
negotiated transactions;
|
·
|
settlement
of short sales entered into after the date of this
Prospectus;
|
·
|
broker-dealers
may agree with the Selling Stockholders to sell a specified number of such
shares at a stipulated price per
share;
|
·
|
a
combination of any such methods of
sale;
|
·
|
through
the writing or settlement of options or other hedging transactions,
whether through an options exchange or otherwise;
or
|
·
|
any
other method permitted pursuant to applicable
law.
|
The
Selling Stockholders may also sell shares under Rule 144 under the Securities
Act, if available, rather than under this Prospectus. There is no
assurance that the Selling Stockholders will sell all or a portion of the stock
being offered hereby.
In
connection with the sale of Shares, the Selling Stockholders may 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. The Selling Stockholders may also sell the Shares short
and deliver these Shares to close out short positions, or loan or pledge the
Shares to broker-dealers or other financial institutions that in turn may sell
these Shares. The Selling Stockholders may also enter into option or other
transactions with broker-dealers or other financial institutions that require
the delivery to the broker-dealer or other financial institution of the Shares,
which the broker-dealer or other financial institution may resell pursuant to
this Prospectus, or enter into transactions in which a broker-dealer makes
purchases as a principal for resale for its own account or through other types
of transactions.
In
connection with the sales, a Selling Stockholder and any participating broker or
dealer may be deemed to be “underwriters” within the meaning of the Securities
Act, and any commissions they receive and the proceeds of any sale of Shares may
be deemed to be underwriting discounts or commissions under the Securities Act.
A Selling Stockholder who is deemed to be an “underwriter” within the meaning of
Section 2(11) of the Securities Act will be subject to the prospectus
delivery requirements of the Securities Act. The Selling Stockholders and any
other person participating in such distribution will be subject to applicable
provisions of the Exchange Act and the rules and regulations thereunder,
including, without limitation, Regulation M. Regulation M may limit the timing
of purchases and sales of shares of our Common Stock by the Selling Stockholders
and any other person. Furthermore, Regulation M may restrict, for a period of up
to five business days prior to the commencement of the distribution, the ability
of any person engaged in a distribution of shares of our Common Stock to engage
in market-making activities with respect to these shares. All of the foregoing
may affect the marketability of shares of our Common Stock and the ability of
any person or entity to engage in market-making activities with respect to
shares of our Common Stock.
To the
extent required, the Shares to be sold, the names of the persons selling the
Shares, the respective purchase prices and public offering prices, the names of
any agent, dealer or underwriter and any applicable commissions or discounts
with respect to a particular offer will be set forth in an accompanying
prospectus supplement or, if appropriate, a post-effective amendment to the
registration statement of which this Prospectus is a part.
We are
bearing all of the fees and expenses relating to the registration of the
Shares. Any underwriting discounts, commissions or other fees payable
to broker-dealers or agents in connection with any sale of the Shares will be
borne by the Selling Stockholders. In order to comply with certain
states’ securities laws, if applicable, the Shares may be sold in such
jurisdictions only through registered or licensed brokers or dealers. In certain
states, the Shares may not be sold unless the Shares have been registered or
qualified for sale in such state, or unless an exemption from registration or
qualification is available and is obtained and complied with. Sales
of the Shares must also be made by the Selling Stockholders in compliance with
all other applicable state securities laws and regulations.
The
Selling Stockholders may agree to indemnify any broker-dealer or agent that
participates in transactions involving sales of the Shares against certain
liabilities in connection with the offering of the Shares arising under the
Securities Act.
We have
notified the Selling Stockholders of the need to deliver a copy of this
Prospectus in connection with any sale of the Shares.
EXPERTS
Our
consolidated financial statements as of December 31, 2007 and
December 31, 2006 and for the years ended December 31, 2007,
December 31, 2006 and December 31, 2005, incorporated by reference in
this Prospectus, and the related financial statement schedule incorporated by
reference in this Prospectus, have been audited by Lazar Levine & Felix LLP,
a registered independent public accounting firm, as stated in its reports
incorporated by reference herein, and are included in reliance upon the reports
of such firm given upon its authority as an expert in accounting and auditing.
The foregoing financial statements have been incorporated by reference herein in
reliance upon such reports given on the authority of such firm as experts in
accounting and auditing.
LEGAL
MATTERS
The
validity of the Shares being offered hereby has been passed upon for the Company
by Patton Boggs LLP. A partner of Patton Boggs LLP owns 225,419 shares of common
stock and warrants to purchase 69,930 shares of our common
stock.
INCORPORATION
OF CERTAIN INFORMATION BY REFERENCE
We
disclose important information to you by referring you to documents that we have
previously filed with the Commission or documents we will file with the
Commission in the future. We hereby incorporate by reference the
following documents into this Prospectus:
·
|
our
Annual Report on Form 10-KSB for the fiscal year ended December 31,
2007, filed with the Commission on March 12,
2008;
|
·
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our
Quarterly Report on Form 10-Q for the quarter ended March 31, 2008
(filed with the Commission on May 12,
2008);
|
·
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our
Current Reports on Form 8-K filed February 22, 2008, March 21, 2008
(except for Items 7.01 and 9.01 and Exhibits 99.1 and 99.2 contained
therein), April 18, 2008 (except for Items 7.01 and 9.01 and Exhibit
99.1), and June 6, 2008 (except for Items 7.01 and 9.01 and Exhibit 99.1
contained therein) pursuant to Section 13 of the Securities Exchange Act
of 1934, as amended; and
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·
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the
description of our Common Stock set forth in our prospectus filed pursuant
to Rule 424(b) of the Securities Act of 1933 (as amended), filed with the
Commission April 2, 2008, and all amendments and reports filed by us to
update that description.
|
Additionally,
all documents filed by us with the SEC under Sections 13(a), 13(c), 14 or 15(d)
of the Securities Exchange Act of 1934, as amended, after the date of this
Prospectus and before the termination or completion of this offering shall be
deemed to be incorporated by reference into this Prospectus from the respective
dates of filing of such documents. Any information that we
subsequently file with the Commission that is incorporated by reference as
described above will automatically update and supersede any previous information
that is part of this Prospectus.
Upon
written or oral request, we will provide you without charge, a copy of any or
all of the documents incorporated by reference, other than exhibits to those
documents unless the exhibits are specifically incorporated by reference in the
documents. Please send requests to Chembio Diagnostics, Inc., 3661
Horseblock Road, Medford, New York 11763, or call
(631) 924-1135.
DISCLOSURE
OF COMMISSION POSITION OF INDEMNIFICATION
FOR
SECURITIES ACT LIABILITIES
Our
directors and officers are indemnified by our bylaws against amounts actually
and necessarily incurred by them in connection with the defense of any action,
suit or proceeding in which they are a party by reason of being or having been
directors or officers of Chembio Diagnostics, Inc. or of our
subsidiary. Our articles of incorporation provide that none of our
directors or officers shall be personally liable for damages for breach of
any fiduciary duty as a director or officer involving any act or omission of any
such director or officer. Insofar as indemnification for liabilities
arising under the Securities Act of 1933, as amended, may be permitted to
such directors, officers and controlling persons pursuant to the 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.
In the
event that a claim for indemnification against such liabilities, other than the
payment by Chembio Diagnostics, Inc. of expenses incurred or paid by such
director, officer or controlling person 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, we will, unless in the
opinion of 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 Securities Act and will be
governed by the final adjudication.
NO
DEALER, SALESMAN OR ANY OTHER PERSON HAS BEEN AUTHORIZED TO GIVE ANY INFORMATION
OR TO MAKE ANY REPRESENTATIONS OTHER THAN THOSE CONTAINED IN THIS PROSPECTUS,
AND, IF GIVEN OR MADE, SUCH INFORMATION OR REPRESENTATIONS MUST NOT BE RELIED
UPON AS HAVING BEEN AUTHORIZED BY THE COMPANY OR ANY SELLING STOCKHOLDER.
NEITHER THE DELIVERY OF THIS PROSPECTUS NOR ANY SALE MADE HEREUNDER SHALL, UNDER
ANY CIRCUMSTANCES, IMPLY THAT THERE HAS BEEN NO CHANGE IN THE AFFAIRS OF THE
COMPANY OR THAT THE INFORMATION HEREIN IS CORRECT AS OF ANY TIME SUBSEQUENT TO
THE DATE AS OF WHICH SUCH INFORMATION IS GIVEN. THIS PROSPECTUS DOES NOT
CONSTITUTE AN OFFER TO SELL OR THE SOLICITATION OF ANY OFFER TO BUY ANY OF THE
SECURITIES OFFERED HEREBY TO ANYONE IN ANY JURISDICTION IN WHICH SUCH OFFER OR
SOLICITATION IS NOT AUTHORIZED OR IN WHICH THE PERSON MAKING SUCH OFFER OR
SOLICITATION IS NOT QUALIFIED TO DO SO OR TO ANYONE TO WHOM IT IS UNLAWFUL TO
MAKE SUCH OFFER OR SOLICITATION.
Table
of Contents:
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Page
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WHERE
YOU CAN FIND ADDITIONAL INFORMATION
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1
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SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS
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1
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SUMMARY
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2
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RISK
FACTORS
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3
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USE
OF PROCEEDS
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10
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SELLING
STOCKHOLDERS
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10
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PLAN
OF DISTRIBUTION
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11
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EXPERTS
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13
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LEGAL
MATTERS
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13
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INCORPORATION
OF CERTAIN INFORMATION BY REFERENCE
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13
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Disclosure
of Commission Position of Indemnification for Securities Act
Liabilities
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14
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CHEMBIO
DIAGNOSTICS, INC. HAS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION,
WASHINGTON, D.C., A REGISTRATION STATEMENT UNDER THE SECURITIES ACT WITH RESPECT
TO THE SHARES OFFERED HEREBY. THIS PROSPECTUS OMITS CERTAIN INFORMATION
CONTAINED IN THE REGISTRATION STATEMENT. THE INFORMATION OMITTED MAY BE OBTAINED
FROM THE SECURITIES AND EXCHANGE COMMISSION UPON PAYMENT OF THE REGULAR CHARGE
THEREFORE.
433,650
SHARES
CHEMBIO
DIAGNOSTICS, INC.
COMMON
STOCK
REOFFER
PROSPECTUS
June 19,
2008
PART
II
INFORMATION
REQUIRED IN THE REGISTRATION STATEMENT
ITEM
3. INCORPORATION OF DOCUMENTS BY REFERENCE
We hereby
incorporate by reference the following documents into this Registration
Statement:
·
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our
Annual Report on Form 10-KSB for the fiscal year ended December 31,
2007, filed with the Commission on March 12,
2008;
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·
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our
Quarterly Report on Form 10-Q for the quarter ended March 31, 2008
(filed May 12, 2008);
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·
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our
Current Reports on Form 8-K filed February 22, 2008, March 21, 2008
(except for Items 7.01 and 9.01 and Exhibits 99.1 and 99.2 contained
therein), April 18, 2008 (except for Items 7.01 and 9.01 and Exhibit
99.1), and June 6, 2008 (except for Items 7.01 and 9.01 and Exhibit 99.1
contained therein) pursuant to Section 13 of the Securities Exchange Act
of 1934, as amended; and
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·
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the
description of our Common Stock set forth in our prospectus filed pursuant
to Rule 424(b) of the Securities Act of 1933 (as amended), filed with the
Commission April 2, 2008, and all amendments and reports filed by us to
update that description.
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All
documents we file pursuant to Sections 13(a), 13(c), 14 and 15(d) of the
Exchange Act subsequent to the date hereof and prior to the filing of a
post-effective amendment that indicates that all securities offered have been
sold or that deregisters all securities then remaining unsold shall be deemed to
be incorporated by reference into this Registration Statement and to be part
hereof from the date of filing of such documents. Any statement
contained in a document incorporated or deemed to be incorporated by reference
herein shall be deemed to be modified or superseded for purposes of this Registration Statement to
the extent that a statement contained herein or in any other subsequently filed
document which also is or is deemed to be incorporated by reference herein
modifies or supersedes such statement. Any such statement so modified
or superseded shall not be deemed, except as so modified or superseded, to
constitute a part hereof.
ITEM
4. DESCRIPTION OF SECURITIES
We
incorporate by reference herein the description of our securities set forth in
our prospectus filed pursuant to Rule 424(b) under the Securities Act of 1933
(as amended), filed on April 2, 2008, File No. 333-138266.
ITEM
5. INTEREST OF NAMED EXPERTS AND COUNSEL
The
validity of the common stock covered by this Registration Statement has been
passed upon for the Company by Patton Boggs LLP. A partner of Patton Boggs LLP
owns 225,419 shares
of common stock and warrants to purchase 69,930 shares of our common
stock.
ITEM
6. INDEMNIFICATION OF DIRECTORS AND OFFICERS
Our
articles of incorporation provide for the indemnification of the directors,
officers, employees and agents of the Company to the fullest extent permitted by
the laws of the State of Nevada. Section 78.7502 of the Nevada
General Corporation Law permits a corporation to indemnify any of its directors,
officers, employees or agents against expenses actually and reasonably incurred
by such person in connection with any threatened, pending or completed action,
suit or proceeding, whether civil, criminal, administrative or investigative
(except for an action by or in right of the corporation) by reason of the fact
that such person is or was a director, officer, employee or agent of the
corporation, provided that it is determined that such person acted in good faith
and in a manner which he 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 conduct was
unlawful.
Section
78.751 of the Nevada General Corporation Law requires that the determination
that indemnification is proper in a specific case must be made by (a) the
stockholders, (b) the board of directors by majority vote of a quorum consisting
of directors who were not parties to the action, suit or proceeding or (c)
independent legal counsel in a written opinion (i) if a majority vote of a
quorum consisting of disinterested directors is not possible or (ii) if such an
opinion is requested by a quorum consisting of disinterested
directors.
Insofar
as indemnification for liabilities arising under the Securities Act of 1933 (the
“Securities Act”) may be permitted to directors, officers and controlling
persons of the registrant pursuant to the foregoing provisions, 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 Securities Act and is, therefore, unenforceable.
ITEM
7. EXEMPTION FROM REGISTRATION CLAIMED
Not
applicable.
ITEM
8. EXHIBITS
The
following documents are filed as exhibits to this Registration
Statement:
Exhibit
Number Exhibit
4.1 2008
Stock Incentive Plan (Incorporated by reference to the Company’s definitive
proxy statement on Form DEF 14A filed with the Commission on April 14,
2008.)
5.1
Opinion and Consent of Patton Boggs LLP
23.1 Consent
of Lazar Levine and Felix LLP
23.2 Consent
of Patton Boggs LLP (included in Exhibit 5.1)
24.1 Power
of Attorney (included on signature page hereto)
ITEM
9. UNDERTAKINGS
The
registrant hereby undertakes:
(a)(1) To
file, during any period in which offers or sales are being made, a
post-effective amendment to this Registration Statement to:
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(i)
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Include
any prospectus required by Section 10(a)(3) of the Securities
Act;
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(ii)
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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 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 changes in volume and
price represent no 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.
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(iii)
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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;
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provided,
however, that paragraphs (a)(1)(i) and (a)(1)(ii) do not apply because this
Registration Statement is on Form S-8 and the information required to be
included in a post-effective amendment by those paragraphs is contained in
periodic reports filed with or furnished to the Commission by the registrant
pursuant to Section 13 or 15(d) of the Exchange Act that are incorporated by
reference to the Registration Statement.
(2) That,
for the purpose of determining any liability under the Securities Act, 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) The
undersigned registrant hereby undertakes that, for purposes of determining any
liability under the Securities Act, each filing of the registrant’s annual
report pursuant to Section 13(a) or 15(d) of the Exchange Act 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 may be
permitted to the directors, officers and controlling persons of the registrant
pursuant to the foregoing provision, or otherwise, the registrant has been
advised that in the opinion of the Commission such indemnification is against
public policy as expressed in the Securities 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 Securities Act and will be governed by final
adjudication of such issue.
SIGNATURES
Pursuant to the requirements of the
Securities Act, the registrant certifies that it has reasonable grounds to
believe that its meets all of the requirements for filing on Form S-8 and has
duly caused this Registration Statement to be signed on its behalf by the
undersigned, thereunto duly authorized, in the city of Medford, State of New
York, on this 19th day of June 2008.
CHEMBIO
DIAGNOSTICS, INC.
By: /s/ Lawrence A. Siebert
Lawrence A. Siebert
President,
Chief Executive Officer and Chairman of the Board
Each
person whose signature appears below appoints Lawrence A. Siebert, individually,
as true and lawful attorneys-in-fact and agents, with full power of substitution
to sign any amendments (including post-effective amendments) to this
Registration Statement and to each registration statement amended hereby, and to
file the same, with all exhibits and other related documents, with the
Commission, with full power and authority to perform any necessary or
appropriate act in connection with the amendment(s).
Pursuant to the requirements of the
Securities Act, this Registration Statement has been signed below by the
following persons in the capacities and on the dates indicated.
By:
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/s/ Lawrence A.
Siebert
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June 19,
2008
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Lawrence
A. Siebert
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President,
Chief Executive Officer and Chairman of the Board
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(Principal
Executive Officer)
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By:
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/s/ Richard J.
Larkin
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June 19,
2008
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Richard
J. Larkin
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Chief
Financial Officer
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(Principal
Financial and Accounting Officer)
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By:
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/s/ Alan
Carus
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June 19,
2008
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Alan
Carus
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Director
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By:
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/s/ Dr. Gary
Meller
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June 19,
2008
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Dr. Gary Meller
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Director
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By:
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June 19,
2008
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Katherine
L. Davis
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Director
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By:
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/s/ James D.
Merselis
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June 19,
2008
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James
D. Merselis
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Director
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EXHIBIT
INDEX
Exhibit
Number Exhibit
4.1
2008
Stock Incentive Plan (Incorporated by reference to the Company’s definitive
proxy statement on Form DEF 14A filed with the Commission on April 14,
2008.)
5.1
Opinion and Consent of Patton Boggs LLP
23.1 Consent
of Lazar Levine and Felix LLP
23.2 Consent
of Patton Boggs LLP (included in Exhibit 5.1)
24.1 Power
of Attorney (included on signature page hereto)