As filed with the Securities and Exchange Commission on July 1, 2008
Registration No. 333-
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM S-3
REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933
ZILA, INC.
(Exact name of registrant as specified in its charter)
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Delaware
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86-0619668
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(State or other jurisdiction of
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(I.R.S. Employer
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incorporation or organization)
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Identification Number)
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5227 North 7th Street
Phoenix, Arizona 85014-2800
(602) 266-6700
(Address, including zip code, and telephone number,
including area code, of registrants principal executive offices)
David R. Bethune
Chairman and Chief Executive Officer
Zila, Inc.
5227 North 7th Street
Phoenix, Arizona 85014-2800
(602) 266-6700
(Name, address, including zip code, and telephone number,
including area code, of agent for service)
Copy to:
Michael M. Donahey, Esq.
Snell & Wilmer L.L.P.
One Arizona Center
Phoenix, Arizona 85004-2202
Telephone: (602) 382-6000
Facsimile: (602) 382-6070
Approximate date of commencement 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.
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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, other than securities
offered only in connection with dividend or interest reinvestment plans, check the following box.
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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.
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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.
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If this Form is a registration statement pursuant to General Instruction I.D. or a
post-effective amendment thereto that shall become effective upon filing with the Commission
pursuant to Rule 462(e) under the Securities Act, check the following box.
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If this Form is a post-effective amendment to a registration statement filed pursuant to
General Instruction I.D. filed to register additional securities or additional classes of
securities pursuant to Rule 413(b) under the Securities Act, check the following box.
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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.
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Large accelerated filer
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Accelerated filer
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Non-accelerated filer
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Smaller reporting company
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(do not check if a smaller reporting company)
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CALCULATION OF REGISTRATION FEE
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Proposed
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Maximum
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Proposed
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Aggregate
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Maximum
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Title of Each Class of
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Amount to be
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Offering
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Aggregate
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Amount of
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Securities to be Registered
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Registered(1)
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Price per Share (2)
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Offering Price (2)
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Registration Fee
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Common Stock, $0.001 par
value per share
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4,626,595
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$0.28
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$1,295,447
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$50.91
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(1)
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Consists of (a) 4,626,595 shares of Zila, Inc. (Zila) common stock, par value $0.001 per
share (the Common Stock) issued to holders of Zilas Amended and Restated Senior Secured
Convertible Notes (the Amended and Restated Notes) to pay a $1,200,000 fee in connection
with the amendment of the terms of the Amended and Restated Notes, and (b) an indeterminate
number of additional shares of Common Stock that may be offered or issued with respect to the
foregoing securities pursuant to Rule 416 of the Securities Act of 1933, as amended (the
Securities Act) as a result of stock splits, stock dividends, recapitalizations or other
capital adjustments.
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(2)
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Estimated solely for the purpose of calculating the registration fee pursuant to Rule 457(c)
of the Securities Act and based upon the average high and low trading prices of Zilas Common
Stock as reported on the Nasdaq Global Market on June 27, 2008.
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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 (a), may determine.
THE INFORMATION IN THIS PROSPECTUS IS NOT COMPLETE AND MAY BE CHANGED. THE
SELLING STOCKHOLDERS NAMED IN THIS PROSPECTUS MAY NOT SELL THESE SECURITIES
UNTIL THE REGISTRATION STATEMENT FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION IS EFFECTIVE. THIS PROSPECTUS IS NOT AN OFFER TO SELL THESE
SECURITIES AND THE SELLING STOCKHOLDERS ARE NOT SOLICITING OFFERS TO BUY THESE
SECURITIES IN ANY STATE WHERE THE OFFER OR SALE IS NOT PERMITTED.
SUBJECT TO COMPLETION, DATED JULY 1, 2008
PRELIMINARY PROSPECTUS
4,626,595 Shares Common Stock
This prospectus relates solely to the resale or other disposition of shares of common stock
issued to the selling stockholders named in this prospectus. On June 4, 2008, Zila, Inc. (Zila)
issued 4,626,595 shares of its common stock, par value $0.001 per share (Common Stock) to holders
of its Amended and Restated Senior Secured Convertible Notes (the Amended and Restated Notes) to
pay a $1,200,000 fee in connection with the amendment of the terms of the Amended and Restated
Notes. These securities were issued in a private placement that was exempt from registration under
the Securities Act.
The selling stockholders may sell or otherwise dispose of the shares from time to time through
public or private transactions or through other means described in the section entitled Plan of
Distribution, beginning on page 10. These dispositions may be at fixed prices, at prevailing
market prices at the time of sale, at prices related to the prevailing market price, at varying
market prices determined at the time of sale or at negotiated prices. We are not selling any
securities under this prospectus and will not receive any of the proceeds from the sale of these
shares by the selling stockholders. We have agreed to pay all costs, expenses and fees relating to
registering such shares of our common stock referenced in this prospectus. The selling
stockholders will pay any brokerage commissions and/or similar charges incurred for the sale of
such shares of our common stock.
Our common stock is quoted on the Nasdaq Global Market under the symbol ZILA. The last
reported sale price for our common stock on June 27, 2008 was $0.25 per share.
Investment in our common stock involves a high degree of risk. See the section entitled Risk
Factors beginning on page 2 of this prospectus for more information regarding these risks.
Neither the Securities and Exchange Commission nor any state securities commission has
approved or disapproved of these securities or determined if this prospectus is truthful or
complete. Any representation to the contrary is a criminal offense.
The date of this prospectus is July , 2008.
TABLE OF CONTENTS
ABOUT THIS PROSPECTUS
You should rely only on the information contained or incorporated by reference in this
prospectus and on the information contained in any prospectus supplements hereto. We have not
authorized anyone to provide you with additional or different information. The selling
stockholders are not offering to sell, nor seeking offers to buy, shares of our common stock in any
jurisdiction where it is unlawful to do so. The information in this prospectus, or any prospectus
supplement, is accurate only as of the date on the front of this document, or on the prospectus
supplement, as appropriate, and any information we have incorporated by reference is accurate only
as of the date of the document incorporated by reference, regardless of the time of delivery of
this prospectus or of any sale of our common stock.
Unless the context otherwise requires, references to Zila, we, us, our or the
company in this prospectus mean Zila, Inc., together with its wholly-owned direct subsidiaries.
Zila and our logo, used alone and with the mark Zila, are our registered service marks and
trademarks.
WHERE YOU CAN FIND MORE INFORMATION
We file reports, proxy statements and other documents with the Securities and Exchange
Commission (SEC). You may read and copy any document we file at the SECs public reference room
at 100 F Street, N.E., Washington, D.C. 20549. You should call 1-800-SEC-0330 for more
information on the public reference room. The SEC maintains an Internet website at
http://www.sec.gov that contains reports, proxy and information statements, and other information
regarding issuers that file electronically with the SEC. Our SEC filings are also available to you
on the SECs Internet site, as well as on the Investor Relations page of our Internet site,
www.zila.com.
This prospectus is part of a registration statement that we filed with the SEC. The
registration statement contains more information than this prospectus regarding us and our common
stock, including certain exhibits and schedules. You can obtain a copy of the registration
statement from the SEC at the address listed above or from the SECs Internet site.
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You may also request a copy of any of our filings with the SEC, or any of the agreements or
other documents that are exhibits to those filings, at no cost, by writing, e-mailing or
telephoning us at the following address, e-mail address or phone number:
Zila, Inc.
5227 North 7th Street
Phoenix, Arizona 85014-2800
investor@zila.com
(602) 266-6700
INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE
We incorporate by reference in this prospectus certain information we file with the SEC under
Sections 13(a), 13(c), 14 or 15(d) of the Securities Exchange Act of 1934, as amended (the
Exchange Act), including (1) any filings after the filing of this registration statement and
prior to the effectiveness of the registration statement and (2) any filings after the date of this
prospectus (which does not include items furnished under Current Reports on Form 8-K or
otherwise), until all of the securities to which this prospectus relates have been sold or this
offering is otherwise terminated. The information that we incorporate by reference is an important
part of this prospectus. Any statement in a document incorporated by reference will be deemed to
be modified or superseded to the extent that a statement contained in (1) this prospectus or (2)
any other subsequently filed document that is incorporated by reference into this prospectus
modifies or supersedes such statement.
We incorporate by reference into this prospectus the following documents:
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our Annual Report on Form 10-K for the fiscal year ended July 31, 2007, filed with
the SEC on October 15, 2007;
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our Quarterly Reports on Form 10-Q for the quarters ended
October 31, 2007, January 31, 2008, and April 30, 2008, filed with
the SEC on December 10, 2007, March 11, 2008, and June 9, 2008;
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our Current Reports on Form 8-K, filed with the SEC on
August 1, 2007, August 14, 2007, August 22, 2007,
August 31, 2007, October 3, 2007, October 29, 2007, November 9,
2007, December 19, 2007, December 21, 2007, January 7, 2008, March 26, 2008, April 4,
2008, April 7, 2008, April 15, 2008, May 2, 2008, May 12, 2008, June 6, 2008, June 12,
2008, and June 18, 2008;
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our Definitive Proxy Statement on Schedule 14A, filed with the SEC on November 9,
2007; and
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the description of our Common Stock contained in our Registration of Certain Classes
of Securities on Form 8-A, dated March 1, 1989.
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FORWARD-LOOKING STATEMENTS
This prospectus, including information incorporated into this document by reference, contains
forward-looking statements within the meaning of Section 27A of the Securities Act and Section
21E of the Exchange Act. Statements that are not historical facts, including statements about our
beliefs or expectations, are forward-looking statements, and are contained throughout this
prospectus and in the information incorporated into this prospectus by reference. Forward-looking
statements are identified by words such as believe, anticipate, expect, estimate, intend,
plan, project, will, may and variations of such words and similar expressions. In
addition, any statements that refer to expectations, projections, plans, objectives, goals,
strategies or other characterizations of future events or circumstances are forward-looking
statements. These forward-looking statements speak only as of the date stated and we do not
undertake any obligation to update or revise publicly any forward-looking statements, whether as a
result of new information, future events or otherwise, even if experience or future events make it
clear that any expected results expressed or implied by these forward-looking statements will not
be realized. Although we believe that the expectations reflected in these forward-looking
statements are reasonable, these expectations may not prove to be correct or we may not achieve the
financial results, savings or other benefits anticipated in the forward-looking statements. These
forward-looking statements are necessarily estimates reflecting the best judgment of our senior
management and involve a number of risks and uncertainties, some of which may be beyond our
control, that could cause actual results to differ materially from those suggested by the
forward-looking
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statements. Factors that could cause actual results or conditions to differ from those
anticipated by these and other forward-looking statements are described more fully in the section
entitled Risk Factors and in the reports we have filed with the SEC under Sections 13(a), 13(c),
14 or 15(d) of the Exchange Act. Our business, financial condition or results of operations could
also be adversely affected by other factors besides those listed here. However, these are the
risks our management currently believes are material.
You should carefully consider the trends, risks and uncertainties described in the section
entitled Risk Factors of this prospectus and other information in this prospectus or reports
filed with the SEC before making any investment decision with respect to the securities. If any of
the trends, risks or uncertainties set forth in the section entitled Risk Factors and in our
reports we have filed with the SEC under Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act
actually occurs or continues, our business, financial condition or operating results could be
materially adversely affected. All forward-looking statements attributable to us or persons acting
on our behalf are expressly qualified in their entirety by this cautionary statement.
PRINCIPAL EXECUTIVE OFFICE
Our headquarters are located at 5227 North 7th Street, Phoenix, Arizona 85014, and our telephone
number is (602) 266-6700.
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PROSPECTUS SUMMARY
The following summary includes basic information about our company and this offering. Because
it is a summary, it does not contain all of the information that you should consider before
investing in our common stock. For a more comprehensive understanding of our company and the
shares of our common stock covered by this prospectus, you should read this entire prospectus
carefully, including the risks of investing discussed under the section entitled Risk Factors and
the information that we have incorporated by reference into this prospectus.
Zila, Inc.
Zila, Inc., a Delaware corporation that is headquartered in Phoenix, Arizona, is an integrated
oral diagnostic company dedicated to the prevention, detection and treatment of oral cancer and
periodontal disease. During fiscal 2007, Zila successfully completed a multi-step strategic
redirection, which included divesting non-core businesses and acquiring the national dental
products company, Professional Dental Technologies, Inc. (Pro-Dentec).
Zila manufactures and markets ViziLite
®
Plus with TBlueTM (ViziLite
®
Plus), its flagship
product for the early detection of oral abnormalities that could lead to cancer. ViziLite
®
Plus is
an adjunctive medical device cleared by the FDA for use in a population at increased risk for oral
cancer. In addition, Zila designs, manufactures and markets a suite of proprietary products sold
exclusively and directly to dental professionals for periodontal disease, including the Rotadent
®
Professional Powered Brush, the Pro-Select Platinum
®
ultrasonic scaler and a portfolio of oral
pharmaceutical products for both in-office and home-care use. All of Zilas products are marketed
and sold in the United States and Canada primarily through the companys direct field sales force
and telemarketing organization. Zilas national marketing programs reach most of the nations
dental offices and include continuing education seminars for dentists and their staffs. The
company is certified by the American Dental Association and the Academy of General Dentistry to
provide continuing education seminars. In October 2006, Zila divested its Nutraceuticals business
unit and in May 2007 the company divested its Peridex
®
brand of prescription periodontal rinse.
With the integration of the operations of Pro-Dentec with the companys former Zila Pharmaceuticals
business unit and the re-alignment of the companys Zila Biotechnology business unit to serve as
its research and development division, Zila has organized itself as one operating segment in
accordance with Statement of Financial Accounting Standards (SFAS) No. 131, Disclosures about
Segments of an Enterprise and Related Information.
The Offering
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Common Stock issued to the selling
stockholders in connection with the
amendment of Zilas Amended and
Restated Senior Secured Convertible
Notes
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4,626,595 shares
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Common Stock issued and outstanding
(including the shares covered by this
Prospectus)
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67,826,861 shares
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Use of proceeds
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Zila will not receive any
proceeds from the sale of the
shares of common stock in this
offering.
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Nasdaq Global Market symbol
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ZILA
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1
RISK FACTORS
You should consider carefully the risk factors described below, and all other information
contained in or incorporated by reference in this prospectus, before deciding to invest in our
common stock. If any of the following risks actually occur, they may materially harm our business,
financial condition, operating results or cash flow. As a result, the market price of our common
stock could decline, and you could lose all or part of your investment. Additional risks and
uncertainties that are not yet identified or that we think are immaterial may also materially harm
our business, operating results or financial condition and could result in a complete loss of your
investment.
Trends, Risks and Uncertainties Related to Our Business
Our lack of earnings history could adversely affect our financial health and prevent us from
fulfilling our payment obligations, and if we are unable to generate funds or obtain funds on
acceptable terms, we may not be able to develop and market our present and potential products.
2
Our liquidity needs have typically arisen from the funding of our research and development
program and the launch of our new products, such as ViziLite
®
Plus, working capital and debt
service requirements, and future strategic initiatives. In the past, we have met these cash
requirements through our cash and cash equivalents, cash from operations and working capital
management, the sale of non-core assets, proceeds from the issuance of common stock under our
employee stock option and stock purchase programs, and proceeds from certain private placements of
our securities.
The development of products, such as OraTest
®
, requires the commitment of substantial
resources to conduct the time-consuming research and development, clinical studies and regulatory
activities necessary to bring any potential product to market and to establish production,
marketing and sales capabilities. Our ability to develop our products, to service our debt
obligations, to fund working capital and capital expenditures, and for other purposes that cannot
at this time be quantified will depend on our future operating performance, which will be affected
by factors discussed elsewhere and in the reports we file with the SEC, including, without limitation,
receipt of regulatory approvals, economic conditions and financial, business, and other factors,
many of which are beyond our control.
After an evaluation of our strategic direction, including an assessment of the OraTest
®
regulatory program, we believe that in order to maximize shareholder value, our resources must be
directed to those products and programs with the greatest probability of financial return. We
believe that our greatest potential lies with our ability to develop and commercialize our oral
cancer screening product, ViziLite
®
Plus. Our analysis concluded that the incremental market
potential of OraTest
®
, considering the availability of ViziLite
®
Plus, does not justify the cost,
time and uncertain study outcomes associated with continuing the program in its current form.
We anticipate that we will be able to pursue our strategy with our currently available funds
through (i) the anticipated growth in our commercial business; (ii) cost reductions in research and
development expenditures on the OraTest
®
regulatory program; and (iii) reduced overhead from our
actions to reorganize and streamline our operations. We, therefore, believe that our cash and cash
equivalents along with cash flows generated from operations and working capital management will
allow us to fund our planned operations over the next 12 months. However, there can be no
assurance that we will be successful in executing these strategies. If we are unable to execute
these strategies, we may break the financial covenants of our senior secured debt and be unable to
repay the outstanding balance of such debt.
In addition, our lack of earnings history and our level of debt could have important
consequences, such as:
making it more difficult for us to satisfy our obligations with respect to our Second
Amended and Restated Senior Secured Convertible Notes;
increasing our vulnerability to general adverse economic and industry conditions;
limiting our flexibility in planning for, or reacting to, changes in our business and our
industry;
restricting us from making strategic acquisitions, introducing new products or exploiting
business opportunities;
requiring us to dedicate a substantial portion of our cash flow from operations to payments
on our indebtedness, which will reduce the amount of our cash flow available for other purposes,
including capital expenditures and other general corporate purposes;
requiring us to sell debt securities or to sell some of our core assets, possibly on
unfavorable terms;
limiting our ability to obtain additional financing; and
placing us at a possible competitive disadvantage compared to our competitors that may have
greater financial resources.
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Our debt instruments contain restrictive covenants that could adversely affect our business by
limiting our flexibility.
Our Second Amended and Restated Secured Notes impose restrictions that affect, among other
things, our ability to incur debt, pay dividends, sell assets, create liens, make capital
expenditures and investments, merge or consolidate, enter into transactions with affiliates, and
otherwise enter into certain transactions outside the ordinary course of business. Our Second
Amended and Restated Secured Notes also require us to maintain defined levels of cash and generate
at least $1 of EBITDA, defined as earnings (loss) before interest, taxes (benefit), depreciation
and amortization for one quarter ending on or before July 31, 2009. Our ability to comply with
these covenants and restrictions may be affected by events beyond our control. If we are unable to
comply with the terms of our Second Amended and Restated Secured Notes, or if we fail to generate
sufficient cash flow from operations to service our debt, we may default on our debt instruments. In the
event of a default under the terms of any of our indebtedness, the debt holders may, under certain
circumstances, accelerate the maturity of our obligations and proceed against their collateral.
We may fail to realize the anticipated cost savings, revenue enhancements, product focus, or other
benefits expected from our recent acquisition of Pro-Dentec.
Our future growth will depend on our ability to implement our business strategy. We believe
that our acquisition of Pro-Dentec, a privately-held dental products company, will strengthen our
business, including the development and commercialization of our oral cancer screening products.
Further, we believe that this acquisition could increase our ability to deliver our products into
the dental marketplace and could result in synergies that enhance our sales capability, potentially
reduce our costs and increase our profits. However, successful acquisitions in our industry are
difficult to accomplish because they require, among other things, efficient integration and
aligning of product offerings and manufacturing operations and coordination of sales and marketing
and research and development efforts. The difficulties of integration and alignment may be
increased by the necessity of coordinating geographically separated organizations, the complexity
of the technologies being integrated and aligned and the necessity of integrating personnel with
disparate business backgrounds and combining different corporate cultures. The integration and
alignment of operations following an acquisition or alliance requires the dedication of management
resources that may distract attention from the day-to-day operations of the business, and may
disrupt key research and development, marketing or sales efforts. In addition, there is no
guarantee that such acquisition will result in the synergies we anticipate. Ultimately, the
success of such acquisition depends in part on the retention of key personnel. There can be no
assurance that we will be able to retain the acquired companys key management, technical, sales
and customer support personnel. If we fail to retain such key employees, we may not realize the
anticipated benefits of such acquisition.
Historically
we have been dependent on a few key products and our future growth is
dependent on the growth of
ViziLite
®
Plus and on the
development and/or acquisition of new products.
In the past, nearly all of our revenues were derived from the sales of Ester-C
®
, Peridex
®
and
ViziLite
®
Plus products. We divested our Nutraceuticals Business Unit and the Ester-C
®
products in
October 2006 and Peridex
®
in May 2007. With the acquisition and addition of the products of
Pro-Dentec, and the change in our distribution method for ViziLite
®
Plus, we now sell direct to
thousands of dental offices nationally and we believe we have reduced our dependency on key
customers.
If any of our major products were to become subject to a problem such as loss of patent
protection, unexpected side effects, regulatory proceedings, publicity adversely affecting user
confidence or pressure from competing products, or if a new, more effective treatment should be
introduced, the impact on our revenues could be significant. Additionally, we are reliant on third
party manufacturers and single suppliers for our ViziLite
®
Plus product, and any supply problems
resulting from regulatory issues applicable to such parties or failures to comply with FDAs
current Good Manufacturing Practices could have a material adverse impact on our financial
condition.
4
Our future growth is dependent on the growth of the ViziLite
®
Plus product and new product
development and/or acquisition. New product initiatives may not be successfully implemented
because of many factors, including, but not limited to, difficulty in assimilation, development
costs and diversion of management time. There can be no assurance that we will successfully
develop and integrate new products into our business that will result in growth and a positive
impact on our business, financial condition and results of operation.
A number of factors could impact our plans to commercialize our new products, including, but
not limited to, difficulties in the production process, controlling the costs to produce, market
and distribute the product on a commercial scale, and our ability to do so with favorable gross
margins and otherwise on a profitable basis; the inherent difficulty of gaining market acceptance
for a new product; competition from larger, more established companies with greater resources;
changes in raw material supplies that could result in production delays and higher raw material
costs; difficulties in promoting consumer awareness for the new product; adverse publicity
regarding the industries in which we market our products; and the cost, timing, and ultimate
results of regulatory program studies that we undertake.
We may be unable to obtain FDA or other regulatory approval for new drugs, devices or products or
to establish markets in the United States and obtaining regulatory approval is costly and
uncertain.
The rigorous clinical testing and extensive regulatory approval process mandated by the Food
and Drug Administration (FDA) and equivalent foreign authorities before any new drug, device or
product can be marketed can take a number of years, require the expenditure of substantial
resources, and approval may not ultimately be obtained.
If FDA approval of a new product is received, such approval may entail limitations on the
indicated uses for which the product may be marketed and there is no assurance that we will be
successful in gaining market acceptance of that product. Moreover, a marketed product, its
manufacturer, its manufacturing facilities, and its suppliers are also subject to continual review
and periodic inspections, and later discovery of previously unknown problems, or the exacerbation
of problems previously deemed acceptable, with a product, manufacturer, or facility may result in
restrictions on such product or manufacturer, potentially including withdrawal of the product from
the market, which would adversely affect our operations and financial condition. The length of the
FDA regulatory process and review period varies considerably, as does the amount of data required
to demonstrate the safety and efficacy of a specific product. If the compounds in testing are
modified or optimized or if certain results are obtained, it may extend the testing process.
Additional testing, delays or rejections may be encountered based upon changes in FDA policy,
personal or prior understandings during the period of product development and FDA regulatory review
of each investigational new drug application, new drug application, or product license application.
Similar delays may also be encountered in other countries. There can be no assurance that even
after such time and expenditures we will obtain regulatory approval for any products we develop.
In its regulation of advertising, the FDA from time to time issues correspondence to
pharmaceutical companies alleging that some advertising or promotional practices are false,
misleading or deceptive. The FDA has the power to impose a wide array of sanctions on companies
for such advertising practices, and the receipt of correspondence from the FDA alleging these
practices can result in the following:
incurring substantial expenses, including fines, penalties, legal fees and costs to comply
with the FDAs requirements
changes in the methods of marketing and selling products
taking FDA-mandated corrective action, which may include placing advertisements or sending
letters to dental professionals and physicians rescinding previous advertisements or promotion
disruption in the distribution of products and loss of sales until compliance with the FDAs
position is obtained.
Our proprietary rights may prove difficult to enforce.
Our current and future success depends on a combination of patent, trademark, and trade secret
protection and nondisclosure and licensing agreements to establish and protect our proprietary
rights. We own and have exclusive licenses to a number of United States and foreign patents and
patent applications and intend to seek additional patent applications as we deem necessary and
appropriate to operate our business. We can offer no assurances regarding the strength of the
patent portfolio underlying any existing or new product and/or technology or whether patents will
be issued from any pending patent applications related to a new product and/or technology, or if
the patents are issued, that any claims allowed will be sufficiently broad to cover the product,
technology or production process. Although we intend to defend our proprietary rights, policing
unauthorized use of intellectual property is difficult or may prove materially costly and any
patents that may be issued relating to new products and technology may be challenged, invalidated
or circumvented.
We are dependent on our senior management and other key personnel.
Our ability to operate successfully depends in significant part upon the experience, efforts,
and abilities of our senior management and other key scientific, technical and managerial
personnel. Competition for talented personnel is intense. The future loss of services of one or
more of our key executives could adversely impact our financial performance and our ability to
execute our strategies. Additionally, if we are unable to attract, train, motivate and retain key
personnel, our business could be harmed.
We and our products are subject to regulatory oversight that could substantially interfere with our
ability to do business.
We and our present and future products are subject to risks associated with new federal,
state, local, or foreign legislation or regulation or adverse determinations by regulators under
existing regulations, including the interpretation of and compliance with existing, proposed, and
future regulatory requirements imposed by the FDA. We are also subject to other governmental
authorities such as the Department of Health and Human Services, the Consumer Products Safety
Commission, the Department of Justice and the United States Federal Trade Commission with its
regulatory authority over, among other items, product safety and efficacy claims made in product
labeling and advertising. Individual states, acting through their attorneys general, have become
active as well, seeking to regulate the marketing of prescription drugs under state consumer
protection and false advertising laws. A regulatory determination or development that affects our
ability to market or produce one or more of our products could have a material adverse impact on
our business, results of operation, and financial condition and may include product recalls, denial
of approvals and other civil and criminal sanctions.
5
We are at risk with respect to product liability claims.
We could be exposed to possible claims for personal injury resulting from allegedly defective
products manufactured by third parties with whom we have entered into manufacturing agreements or
by us. We maintain $6.0 million in product liability insurance coverage for claims arising from
the use of our products, with limits we believe are commercially reasonable under the
circumstances, and, in most instances, require our manufacturers to carry product liability
insurance. While we believe our insurance coverage is adequate, we could be subject to product
liability claims in excess of our insurance coverage. In addition, we may be unable to retain our
existing coverage in the future. Any significant product liability claims not within the scope of
our insurance coverage could have a material adverse effect on us.
We face significant competition that could adversely affect our results of operation and financial
condition.
The pharmaceutical, medical device and related industries are highly competitive. A number of
companies, many of which have financial resources, marketing capabilities, established
relationships, superior experience and operating history, and research and development capacities
greater than ours, are actively engaged in the development of products similar to the products we
produce and market. The pharmaceutical industry is characterized by extensive and ongoing research
efforts. Other companies may succeed in developing products superior to those we market. It may
be difficult for us to maintain or increase sales volume and market share due to such competition
which would adversely affect our results of operations and financial condition. The loss of any of
our products patent protection could lead to a significant loss in sales of our products in the
United States market.
If the use of our technology is determined to infringe on the intellectual property rights of
others, our business could be harmed.
Litigation may result from our use of registered trademarks or common law marks and, if
litigation against us were successful, a resulting loss of the right to use a trademark could
reduce sales of our products and could result in a significant damage award. International
operations may be affected by changes in intellectual property legal protections and remedies in
foreign countries in which we do business.
Furthermore, if it were ultimately determined that our intellectual property rights are
unenforceable, or that our use of our technology infringes on the intellectual property rights of
others, we may be required or may desire to obtain licenses to patents and other intellectual
property held by third parties to develop, manufacture and market products using our technology.
We may not be able to obtain these licenses on commercially reasonable terms, if at all, and any
licensed patents or intellectual property that we may obtain may not be valid or enforceable. In
addition, the scope of intellectual property protection is subject to scrutiny and challenge by
courts and other governmental bodies. Litigation and other proceedings concerning patents and
proprietary technologies can be protracted, expensive and distracting to management and companies
may sue competitors as a way of delaying the introduction of competitors products. Any
litigation, including any interference proceedings to determine priority of inventions, oppositions
to patents in foreign countries or litigation against our partners, may be costly and
time-consuming and could significantly harm our business.
Because of the large number of patent filings in our industry, our competitors may have filed
applications or been issued patents and may obtain additional patents and proprietary intellectual
property rights relating to products or processes competitive with or similar to ours. We cannot
be certain that United States or foreign patents do not exist or will not be issued that would harm
our ability to commercialize our products and product candidates. In addition, our exposure to
risks associated with the use of intellectual property may be increased as a result of an
acquisition as we have lower visibility into any potential targets safeguards and infringement
risks. In addition, third party claims may be asserted after we have acquired technology that had
not been asserted prior to such acquisition.
6
We require certain raw materials for our manufacturing processes that may only be acquired through
limited sources.
Raw materials essential to our business are generally readily available. However, certain raw
materials and components used in the manufacture of pharmaceutical and medical device products are
available from limited sources, and in some cases, a single source. Any curtailment in the
availability of such raw materials could be accompanied by production delays, and in the case of
products, for which only one raw material supplier exists, could result in a material loss of
sales. In addition, because raw material sources for products must generally be approved by
regulatory authorities, changes in raw material suppliers could result in production delays, higher
raw material costs and loss of sales and customers. Production delays may also be caused by the
lack of secondary suppliers.
We have, in the past, received minor deficiencies from regulatory agencies related to our
manufacturing facilities.
The FDA, Occupational Safety and Health Administration (OSHA) and other regulatory agencies
periodically inspect our manufacturing facilities and certain facilities of our suppliers. In the
past, such inspections resulted in the identification of certain minor deficiencies in the
standards we are required to maintain by such regulatory agencies. We developed and implemented
action plans to remedy the deficiencies; however, there can be no assurance that such deficiencies
will be remedied to the satisfaction of the applicable regulatory body. In the event that we are
unable to remedy such deficiencies, our product supply could be affected as a result of plant
shutdown, product recall or other similar regulatory actions, which would likely have an adverse
affect on our business, financial condition, and results of operation.
Trends, Risks and Uncertainties Related to Our Capital Stock
The Private Placements and other financing arrangements or corporate events could significantly
dilute existing ownership.
Following the August 13, 2007 and June 3, 2008 restructurings of the securities issued in the
private placements that the company consummated in
November 2006, an additional approximately 13,950,000 shares of our common stock would be issued should investors convert all Second Amended
and Restated Secured Notes and exercise all warrants issued in connection with the private
placements, which would dilute existing shareholders current ownership percentages and voting
power. If we choose to raise additional funds through the issuance of shares of our common stock,
or securities convertible into our common stock, significant dilution of ownership in our company
may occur, and holders of such securities may have rights senior to those of the holders of our
common stock. If we obtain additional financing by issuing debt securities, the terms of these
securities could restrict or prevent us from paying dividends and could limit our flexibility in
making business decisions. Moreover, other corporate events such as the exercise of outstanding
options would result in further dilution of ownership for existing shareholders.
In the past, we have experienced volatility in the market price of our common stock and we may
experience such volatility in the future.
The market price of our common stock has fluctuated significantly in the past. Stock markets have
experienced extreme price volatility in recent years. This volatility has had a substantial effect
on the market prices of securities we and other pharmaceutical and health care companies have
issued, often for reasons unrelated to the operating performance of the specific companies.
In the past, stockholders of other companies have initiated securities class action litigation
against such companies following periods of volatility in the market price of the applicable common
stock. We anticipate that the market price of our common stock may continue to be volatile. If
the market price of our common stock continues to fluctuate and our stockholders initiate this type
of litigation, we could incur substantial costs and
7
expenses and such litigation could divert our managements attention and resources, regardless
of the outcome, thereby adversely affecting our business, financial condition and results of
operation.
We may take actions which could dilute current equity ownership or prevent or delay a change in our
control.
In December 2006, our Board of Directors and stockholders approved an increase in our
authorized capital stock from 67,500,000 to 150,000,000 and an increase in authorized common stock
from 65,000,000 to 147,500,000. Some of these newly authorized shares are reserved for issuance
upon the exercise or conversion of certain securities issued in the November 2006 private
placements. Subject to the rules and regulations promulgated by Nasdaq and the SEC, our Board of
Directors could authorize the sale and issuance of additional shares of common stock, which would
have the effect of diluting the ownership interests of our stockholders.
In addition, our Board of Directors has the authority, without any further vote by our
stockholders, to issue up to 2,500,000 shares of Preferred Stock in one or more series and to
determine the designations, powers, preferences and relative, participating, optional or other
rights thereof, including without limitation, the dividend rate (and whether dividends are
cumulative), conversion rights, voting rights, rights and terms of redemption, redemption price and
liquidation preference. On February 1, 2001, we issued 100,000 shares of our Series B Convertible
Preferred Stock in connection with an acquisition. As of July 31, 2007 and the date of this
filing, all of these shares remained outstanding. If the Board of Directors authorizes the issuance
of additional shares of Preferred Stock, such an issuance could have the effect of diluting the
ownership interests of our common stockholders.
Failure to maintain NASDAQ Marketplace Rules could materially and adversely affect our business.
On March 20, 2008, Zila received a Nasdaq Staff Deficiency Letter indicating that for the
prior 30 consecutive business days, the bid price of its common stock has closed below $1.00 per
share. As a result, the company fails to comply with the minimum bid price requirement for
continued listing set forth in Marketplace Rule 4450(a)(5). In accordance with Marketplace Rule
4450(e)(2), the company has been provided 180 calendar days, or until September 16, 2008, to regain
compliance. Zila will achieve compliance, if before September 16, 2008, the bid price of the
companys common stock closes at $1.00 per share or more for a minimum of 10 consecutive business
days. If the company does not regain compliance by September 16, 2008, but can demonstrate as of
that date that the company meets the criteria for initial listing set forth in Marketplace Rule
4310(c) (other than the bid price requirement) and its application is approved, the company will
have an additional 180 days to regain compliance while on The Nasdaq Capital Market. In the event
that we were delisted from the NASDAQ Global Market, our common stock would become significantly
less liquid, which would adversely affect its value. Although our common stock would likely be
traded over-the-counter or on pink sheets, these types of listings involve more risk and trade less
frequently and in smaller volumes than securities traded on the NASDAQ Global Market.
In addition, our Audit Committee is currently only comprised of two directors. In accordance
with NASDAQ Marketplace Rule 4350(d), we are required to have an audit committee consisting of at
least three independent directors in order to remain listed on the NASDAQ Global Market. We have
until the earlier of our next annual shareholders meeting or one year from the vacancy that caused
the failure to comply with this requirement to regain compliance with NASDAQs rule on audit
committee composition.
USE OF PROCEEDS
We are registering these shares pursuant to the registration rights granted to the selling
stockholders. We are not selling any securities under this prospectus and will not receive any of
the proceeds from the sale or other disposition of these shares by the selling stockholders. We
have agreed to pay all costs, expenses and fees relating to registering such shares of our common
stock referenced in this prospectus. The selling stockholders will pay any brokerage commissions
and/or similar charges incurred for the sale of such shares of our common stock.
8
SELLING STOCKHOLDERS
This prospectus relates to the possible resale or other disposition by the selling
stockholders of 4,626,595 shares of Common Stock that we issued on June 4, 2008 to pay a $1,200,000
fee in connection with the amendment of the terms of our Amended and Restated Secured Notes. On
June 3, 2008, we entered into a registration rights agreement with the selling stockholders, which
obligates us to register the shares of Common Stock that we issued to pay the amendment fee.
The following table presents information regarding the selling stockholders and the shares
that they may offer and sell from time to time under this prospectus. This table is prepared based
on information supplied to us by the selling stockholders, and reflects holdings as of June 5,
2008. As used in this prospectus, the term selling stockholders includes the entities listed
below and any donees, pledges, transferees or other successors in interest selling shares received
after the date of this prospectus from any of the selling stockholders as a gift, pledge or other
transfer. Except as set forth in the footnotes below, beneficial ownership is determined in
accordance with Rule 13d-3(d) promulgated by the SEC under the Exchange Act.
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Shares of Common Stock
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Shares of Common Stock
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Beneficially Owned
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Number of
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Beneficially Owned
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Prior to Offering
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Shares Being
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After Offering
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Security Holders
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Number(1)
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Percent(2)
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Offered
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Number(3)
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Percent(3)
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Atlas Master Fund, Ltd. (c/o BAM) (4)
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3,326,711
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4.76
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%
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771,099
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2,555,612
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3.66
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%
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Atlas Master Fund, Ltd. (c/o Visium) (5)
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492,258
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*
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233,880
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258,378
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*
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Visium Balanced Fund, LP (5)
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1,841,046
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2.68
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%
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874,707
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966,339
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1.41
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%
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Visium Balanced Offshore Fund, Ltd (5)
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3,065,788
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4.44
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%
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1,456,599
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1,609,189
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2.33
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%
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Visium Long Bias Fund, LP (5)
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567,078
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*
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269,427
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297,651
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*
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Visium Long Bias Offshore Fund, Ltd (5)
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2,148,709
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3.13
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%
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1,020,883
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1,127,826
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1.64
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%
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(1)
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Represents all of the shares owned by the selling stockholder as of
June 5, 2008, including those issuable upon the exercise of any
warrants and/or the conversion of any convertible securities owned by
the selling stockholder. The number of shares beneficially owned by
the selling stockholder may increase as a result of accrued dividends
or anti-dilution adjustments.
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(2)
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The percentage of shares beneficially owned prior to the offering is
based on 67,826,861 shares of our common stock outstanding as of June
5, 2008. Shares of common stock subject to options or warrants
currently exercisable or exercisable within 60 days of the date of
this prospectus, and shares of common stock subject to convertible
securities currently convertible or convertible within 60 days of the
date of this prospectus, are deemed outstanding for computing the
percentage of the person holding such options, warrants or convertible
securities, but are not deemed outstanding for computing the
percentage for any other selling stockholder.
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(3)
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The number of shares and percentage of ownership in these columns
assumes that the selling stockholders will offer and sell all of the
shares of common stock registered under this prospectus. The selling
stockholders may elect to sell some, all or none of their shares. We
do not know how long the selling stockholders will hold the shares
before selling them. Other than an agreement by the selling
stockholders that they will retain at least one-half of the shares
registered hereunder until at least September 1, 2008, we currently have no agreements, arrangements
or understandings with the selling stockholders regarding the sale of
any of the shares. Shares of common stock subject to options or
warrants currently exercisable or exercisable within 60 days of the
date of this prospectus, and shares of common stock subject to
convertible securities currently convertible or convertible within 60
days of the date of this prospectus, are deemed outstanding for
computing the percentage of the person holding such options, warrants
or convertible securities, but are not deemed outstanding for
computing the percentage for any other selling stockholder.
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(4)
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Dmitry Balyasny, as Managing Member of Balyasny Asset Management, L.P.
(BAM), has voting and dispositive power with respect to the shares
of this selling stockholder that are registered under this prospectus.
Mr. Balyasny disclaims beneficial ownership of any such shares.
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(5)
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Jacob Gottlieb as Managing Member of Visium Asset Management, LLC
(Visium), the investment advisor to the selling stockholder and
Dmitry Balyasny as Managing Member of BAM, the investment sub-advisor
to Visium, have voting and dispositive power with respect to the
shares of this selling stockholder that are registered under this
prospectus. Both Messrs. Gottlieb and Balyasny disclaim beneficial
ownership of any such shares.
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9
PLAN OF DISTRIBUTION
The selling stockholders, which as used herein includes donees, pledgees, transferees or other
successors-in-interest selling shares of common stock or interests in shares of common stock
received after the date of this prospectus from a selling stockholder as a gift, pledge,
partnership distribution or other transfer, may, from time to time, sell, transfer or otherwise
dispose of any or all of their shares of common stock or interests in shares of common stock on any
stock exchange, market or trading facility on which the shares are traded or in private
transactions. These dispositions may be at fixed prices, at prevailing market prices at the time
of sale, at prices related to the prevailing market price, at varying prices determined at the time
of sale, or at negotiated prices.
The selling stockholders may use any one or more of the following methods when disposing of
shares or interests therein:
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;
privately negotiated transactions;
short sales effected after the date the registration statement of which this Prospectus is a
part is declared effective by the SEC;
through the writing or settlement of options or other hedging transactions, whether through
an options exchange or otherwise;
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; and
any other method permitted by applicable law.
The selling stockholders may, from time to time, pledge or grant a security interest in some
or all of the shares of common stock owned by them and, if they default in the performance of their
secured obligations, the pledgees or secured parties may offer and sell the shares of common stock,
from time to time, under this prospectus, or under an amendment to this prospectus under Rule
424(b)(3) or other applicable provision of the Securities Act amending the list of selling
stockholders to include the pledgee, transferee or other successors in interest as selling
stockholders under this prospectus. The selling stockholders also may transfer the shares of
common stock in other circumstances, in which case the transferees, pledgees or other successors in
interest will be the selling beneficial owners for purposes of this prospectus.
In connection with the sale of our common stock or interests therein, 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 common stock in the course of hedging the positions they
assume. The selling stockholders may also sell shares of our common stock short and deliver these
securities to close out their short positions, or loan or pledge the common stock to broker-dealers
that in turn may sell these securities. The selling stockholders may also enter into option or
other transactions with broker-dealers or other financial institutions or the creation of one or
more derivative securities which require the delivery to such broker-dealer or other financial
institution of shares offered by this prospectus, which shares such broker-dealer or other
financial institution may resell pursuant to this prospectus (as supplemented or amended to reflect
such transaction).
10
The aggregate proceeds to the selling stockholders from the sale of the common stock offered
by them will be the purchase price of the common stock less discounts or commissions, if any. Each
of the selling stockholders reserves the right to accept and, together with their agents from time
to time, to reject, in whole or in part, any proposed purchase of common stock to be made directly
or through agents. We will not receive any of the proceeds from this offering.
The selling stockholders also may resell all or a portion of the shares in open market
transactions in reliance upon Rule 144 under the Securities Act of 1933, provided that they meet
the criteria and conform to the requirements of that rule.
The selling stockholders and any underwriters, broker-dealers or agents that participate in
the sale of the common stock or interests therein may be underwriters within the meaning of
Section 2(11) of the Securities Act. Any discounts, commissions, concessions or profit they earn
on any resale of the shares may be underwriting discounts and commissions under the Securities Act.
Selling stockholders who are underwriters within the meaning of Section 2(11) of the Securities
Act will be subject to the prospectus delivery requirements of the Securities Act.
To the extent required, the shares of our common stock to be sold, the names of the selling
stockholders, the respective purchase prices and public offering prices, the names of any agents,
dealer or underwriter, 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 that includes this prospectus.
In order to comply with the securities laws of some states, if applicable, the common stock
may be sold in these jurisdictions only through registered or licensed brokers or dealers. In
addition, in some states the common stock may not be sold unless it has been registered or
qualified for sale or an exemption from registration or qualification requirements is available and
is complied with.
We have advised the selling stockholders that the anti-manipulation rules of Regulation M
under the Exchange Act may apply to sales of shares in the market and to the activities of the
selling stockholders and their affiliates. In addition, to the extent applicable we will make
copies of this prospectus (as it may be supplemented or amended from time to time) available to the
selling stockholders for the purpose of satisfying the prospectus delivery requirements of the
Securities Act. The selling stockholders may indemnify any broker-dealer that participates in
transactions involving the sale of the shares against certain liabilities, including liabilities
arising under the Securities Act.
We have agreed to indemnify the selling stockholders against liabilities, including
liabilities under the Securities Act and state securities laws, relating to the registration of the
shares offered by this prospectus.
We have agreed with the selling stockholders to keep the registration statement of which this
prospectus constitutes a part effective until the earlier of (1) such time as all of the shares
covered by this prospectus have been disposed of pursuant to and in accordance with the
registration statement or (2) the date on which the shares may be sold without restriction pursuant
to Rule 144 of the Securities Act.
LEGAL MATTERS
The validity of the securities being offered by this prospectus will be passed upon for us by
Snell & Wilmer L.L.P., of Phoenix, Arizona.
EXPERTS
The
financial statements and schedules as of July 31, 2007
and 2006 and for each of the three
years in the period ended July 31, 2007 and managements assessment of the effectiveness of internal control over
financial reporting as of July 31, 2007 incorporated by
reference in this Prospectus have been so incorporated in reliance on the
11
reports of BDO Seidman, LLP, an independent registered public accounting firm, incorporated
herein by reference, given on the authority of said firm as experts in auditing and accounting.
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 14. Other Expenses of Issuance and Distribution.
The following table sets forth all expenses, other than the underwriting discounts and
commissions, payable by the registrant in connection with the sale of the securities being
registered. All the amounts shown are estimates except for the registration fee.
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Securities and Exchange Commission Registration Fee
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$
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51
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Legal Fees and Expenses
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10,000
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Accountants Fees and Expenses
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15,000
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Printing Expenses
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10,000
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Miscellaneous
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949
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Total
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$
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36,000
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Item 15. Indemnification of Directors and Officers.
Under Section 145 of the Delaware General Corporation Law, we can indemnify any person who is,
or is threatened to be made, a party to any threatened, pending or completed legal action, suit or
proceeding, whether civil, criminal, administrative or investigative other than action by us or on
our behalf, by reason of the fact that such person is or was one of our officers or directors, or
is or was serving at our request as a director, officer, employee or agent of another corporation
or enterprise. The indemnity may include expenses including attorneys fees, judgments, fines and
amounts paid in settlement actually and reasonably incurred by such person in connection with such
action, suit or proceeding, provided that such officer or director acted in good faith and in a
manner he or she reasonably believed to be in or not opposed to our best interests, and, for
criminal proceedings, had no reasonable cause to believe his or her conduct was illegal. Under
Delaware law, we may also indemnify officers and directors in an action by us or on our behalf
under the same conditions, except that no indemnification is permitted without judicial approval if
the officer or director is adjudged to be liable to us in the performance of his or her duty.
Where an officer or director is successful on the merits or otherwise in the defense of any action
referred to above, we must indemnify him or her against the expenses which such officer or director
actually and reasonably incurred.
Our Certificate of Incorporation, as amended, provides for the elimination of liability of
monetary damages for breach of the directors fiduciary duty of care to us and our stockholders.
These provisions do not eliminate the directors duty of care and, in appropriate circumstances,
equitable remedies such as injunctive or other forms of non-monetary relief will remain available
under Delaware law. In addition, each director will continue to be subject to liability for breach
of the directors duty of loyalty to us, for acts or omissions not in good faith or involving
intentional misconduct, for known violations of law, for any transaction from which the director
derived an improper personal benefit and for payment of dividends or approval of stock repurchases
or redemptions that are unlawful under Delaware law. The provisions do not affect a directors
responsibilities under any other laws, such as the federal securities laws or state or federal
environmental laws.
Item 16. Exhibits.
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Exhibit
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Number
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Description
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4.1
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Certificate of Incorporation (incorporated by reference to Exhibit 3-A filed
with the Companys Form 10-K for the year ended July 31, 1999)
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4.2
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Certificate of Amendment to Certificate of Incorporation (incorporated by
reference to Exhibit 3-B filed with the Companys Form 10-K for the year ended
July 31, 2005)
|
12
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|
|
Exhibit
|
|
|
Number
|
|
Description
|
4.3
|
|
Certificate of Amendment to Certificate of Incorporation (incorporated by
reference to Exhibit 4.3 filed with the Companys Form S-3 Registration
Statement No. 333-139698 on December 28, 2006)
|
|
|
|
4.4
|
|
Certificate of Designations, Preferences and Rights of Series B Convertible
Stock (incorporated by reference to Exhibit 3-D filed with the Companys Form
10-K for the year ended July 31, 2001)
|
|
|
|
4.5
|
|
Amended and Restated Bylaws (incorporated by reference to Exhibit 3.1 filed with
the Companys Form 8-K on August 22, 2007)
|
|
|
|
4.6
|
|
Registration Rights Agreement dated June 3, 2008, by and among Zila, Inc. and
the investor parties thereto (incorporated by reference to Exhibit 4.2 filed
with the Companys Form 8-K on June 6, 2008)
|
|
|
|
5.1
|
|
Opinion of Snell & Wilmer L.L.P. (filed herewith)
|
|
|
|
23.1
|
|
Consent of BDO Seidman, LLP (filed herewith)
|
|
|
|
23.2
|
|
Consent of Snell & Wilmer L.L.P. (included with opinion filed as Exhibit 5.1)
|
|
|
|
24.1
|
|
Power of Attorney (included on the signature page of this registration statement)
|
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;
|
|
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(ii)
|
|
To reflect in the prospectus any facts or events arising after
the effective date of the registration statement (or the most recent
post-effective amendment thereof) which, individually or in the aggregate,
represent a fundamental change in the information set forth in the registration
statement. Notwithstanding the foregoing, any increase or decrease in volume of
securities offered (if the total dollar value of securities offered would not
exceed that which was registered) and any deviation from the low or high end of
the estimated maximum offering range may be reflected in the form of prospectus
filed with the Commission pursuant to Rule 424(b) if, in the aggregate, the
changes in volume and price represent no more than 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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|
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(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;
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|
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Provided, however,
Paragraphs (a)(1)(i), (a)(1)(ii) and (a)(1)(iii) of this
section do not apply if the registration statement is on Form S-3 or Form
F-3 and the information required to be included in a post-effective
amendment by those paragraphs is contained in reports filed with or
furnished to the Commission 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, or is contained in a form of
prospectus filed pursuant to Rule 424(b) that is part of the registration
statement.
|
13
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(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.
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(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.
|
|
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(4)
|
|
That, for the purpose of determining liability under the Securities Act of 1933
to any purchaser:
|
|
(i)
|
|
Each prospectus filed by the registrant pursuant to Rule
424(b)(3)shall be deemed to be part of the registration statement as of the
date the filed prospectus was deemed part of and included in the registration
statement; and
|
|
|
(ii)
|
|
Each prospectus required to be filed pursuant to Rule
424(b)(2), (b)(5), or (b)(7) as part of a registration statement in reliance on
Rule 430B relating to an offering made pursuant to Rule 415(a)(1)(i), (vii), or
(x) for the purpose of providing the information required by section 10(a) of
the Securities Act of 1933 shall be deemed to be part of and included in the
registration statement as of the earlier of the date such form of prospectus is
first used after effectiveness or the date of the first contract of sale of
securities in the offering described in the prospectus. As provided in Rule
430B, for liability purposes of the issuer and any person that is at that date
an underwriter, such date shall be deemed to be a new effective date of the
registration statement relating to the securities in the registration statement
to which that prospectus relates, and the offering of such securities at that
time shall be deemed to be the initial bona fide offering thereof. Provided,
however, that no statement made in a registration statement or prospectus that
is part of the registration statement or made in a document incorporated or
deemed incorporated by reference into the registration statement or prospectus
that is part of the registration statement will, as to a purchaser with a time
of contract of sale prior to such effective date, supersede or modify any
statement that was made in the registration statement or prospectus that was
part of the registration statement or made in any such document immediately
prior to such effective date; or
|
|
(5)
|
|
That, for the purpose of determining liability of the registrant under the
Securities Act of 1933 to any purchaser in the initial distribution of the securities:
The undersigned registrant undertakes that in a primary offering of securities of the
undersigned registrant pursuant to this registration statement, regardless of the
underwriting method used to sell the securities to the purchaser, if the securities are
offered or sold to such purchaser by means of any of the following communications, the
undersigned registrant will be a seller to the purchaser and will be considered to
offer or sell such securities to such purchaser:
|
|
(i)
|
|
Any preliminary prospectus or prospectus of the undersigned
registrant relating to the offering required to be filed pursuant to Rule 424;
|
|
|
(ii)
|
|
Any free writing prospectus relating to the offering prepared
by or on behalf of the undersigned registrant or used or referred to by the
undersigned registrant;
|
|
|
(iii)
|
|
The portion of any other free writing prospectus relating to
the offering containing material information about the undersigned registrant
or its securities provided by or on behalf of the undersigned registrant; and
|
|
|
(iv)
|
|
Any other communication that is an offer in the offering made
by the undersigned registrant to the purchaser.
|
|
(6)
|
|
The undersigned registrant hereby undertakes that, for purposes of determining
any liability under the Securities Act of 1933, each filing of the registrants annual
report pursuant to section 13(a) or
|
14
|
|
|
section 15(d) of the Securities Exchange Act of 1934 (and, where applicable, each
filing of an employee benefit plans annual report pursuant to section 15(d) of the
Securities Exchange Act of 1934) that is incorporated by reference in the
registration statement shall be deemed to be a new registration statement relating
to the securities offered therein, and the offering of such securities at that time
shall be deemed to be the initial bona fide offering thereof.
|
|
|
(7)
|
|
Insofar as indemnification for liabilities arising under the Securities Act of 1933 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 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.
|
15
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the registrant certifies that it
has reasonable grounds to believe that it meets all of the requirements for filing on Form S-3 and
has duly caused this registration statement to be signed on its behalf by the undersigned,
thereunto duly authorized, in the City of Phoenix, State of Arizona, on the 1st day of July, 2008.
|
|
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|
|
ZILA, INC.
|
|
|
By:
|
/s/ David R. Bethune
|
|
|
|
David R. Bethune
|
|
|
|
Chairman and Chief Executive Officer
|
|
|
POWER OF ATTORNEY
We, the undersigned officers and directors of Zila, Inc., and each of us, do hereby constitute
and appoint David R. Bethune and Gary V. Klinefelter, and each of them individually, as our true
and lawful attorneys and agents, with full power of substitution and resubstitution, to do any and
all acts and things in our name and behalf in any and all capacities and to execute any and all
instruments for us in our names, in connection with this registration statement or any registration
statement for the same offering that is to be effective upon filing under the Securities Act of
1933, as amended, and to file the same, with all exhibits thereto and other documents in connection
therewith, with the Securities and Exchange Commission, including specifically, but without
limitation, power and authority to sign for us or any of us in our names in the capacities
indicated below, any and all amendments (including post-effective amendments) hereto; and we hereby
ratify and confirm all that said attorneys and agents, or their substitutes, shall do or cause to
be done by virtue thereof.
Pursuant to the requirements of the Securities Act of 1933, this registration statement has
been signed by the following persons in the capacities and as of the dates indicated.
|
|
|
|
|
Signature
|
|
Title
|
|
Date
|
|
|
|
|
|
/s/ David R. Bethune
|
|
Chairman and Chief Executive Officer
|
|
July 1, 2008
|
|
|
(Principal Executive Officer)
|
|
|
|
|
|
|
|
/s/ Diane E. Klein
|
|
Vice President Finance and Treasurer
|
|
July 1, 2008
|
|
|
(Principal Financial and Accounting Officer)
|
|
|
|
|
|
|
|
/s/ J. Steven Garrett
|
|
Director
|
|
July 1, 2008
|
|
|
.
|
|
|
|
|
|
|
|
/s/ Leslie H. Green
|
|
Director
|
|
July 1, 2008
|
|
|
|
|
|
|
|
|
|
|
/s/ O.B. Parrish
|
|
Director
|
|
July 1, 2008
|
|
|
|
|
|
|
|
|
|
|
/s/ George J. Vuturo
|
|
Director
|
|
July 1, 2008
|
|
|
|
|
|
EXHIBIT INDEX
|
|
|
Exhibit
|
|
|
Number
|
|
Description
|
4.1
|
|
Certificate of Incorporation (incorporated by reference to Exhibit 3-A filed
with the Companys Form 10-K for the year ended July 31, 1999)
|
|
|
|
4.2
|
|
Certificate of Amendment to Certificate of Incorporation (incorporated by
reference to Exhibit 3-B filed with the Companys Form 10-K for the year ended
July 31, 2005)
|
|
|
|
4.3
|
|
Certificate of Amendment to Certificate of Incorporation (incorporated by
reference to Exhibit 4.3 filed with the Companys Form S-3 Registration
Statement No. 333-139698 on December 28, 2006)
|
|
|
|
4.4
|
|
Certificate of Designations, Preferences and Rights of Series B Convertible
Stock (incorporated by reference to Exhibit 3-D filed with the Companys Form
10-K for the year ended July 31, 2001)
|
|
|
|
4.5
|
|
Amended and Restated Bylaws (incorporated by reference to Exhibit 3.1 filed with
the Companys Form 8-K on August 22, 2007)
|
|
|
|
4.6
|
|
Registration Rights Agreement dated June 3, 2008, by and among Zila, Inc. and
the investor parties thereto (incorporated by reference to Exhibit 4.2 filed
with the Companys Form 8-K on June 6, 2008)
|
|
|
|
5.1
|
|
Opinion of Snell & Wilmer L.L.P. (filed herewith)
|
|
|
|
23.1
|
|
Consent of BDO Seidman, LLP (filed herewith)
|
|
|
|
23.2
|
|
Consent of Snell & Wilmer L.L.P. (included with opinion filed as Exhibit 5.1)
|
|
|
|
24.1
|
|
Power of Attorney (included on the signature page of this registration statement)
|
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