<PAGE> 1
As filed with the Securities and Exchange Commission on February __, 1998
Registration No. 333-_____
================================================================================
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
---------------------------------------
FORM S-3
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
Saliva Diagnostic Systems, Inc.
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(Exact name of registrant as specified in its charter)
DELAWARE
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(State or other jurisdiction of incorporation or organization)
91-1549305
------------------------------------
(I.R.S. Employer Identification No.)
11719 NE 95th Street
Vancouver, Washington 98682
(360) 696-4800
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(Address, including zip code, and telephone number,
including area code, of registrant's principal executive offices)
Kenneth J. McLachlan, President
Saliva Diagnostic Systems, Inc.
11719 NE 95th Street
Vancouver, Washington 98682
(360) 696-4800
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(Name, address, including zip code, and telephone number,
including area code, of agent for service)
Copies of all correspondence to:
LaDawn Naegle, Esq.
Bryan Cave LLP
700 13th Street, N.W., Suite 700
Washington, D.C. 20005-3960
(202) 508-6000
Approximate date of commencement of proposed sale to public: From time to
time after this Registration Statement becomes effective.
<PAGE> 2
If the only securities being registered on this form are being offered
pursuant to dividend or interest reinvestment plans, please check the following
box. [ ]
If any of the securities being registered on this form are to be offered on
a delayed or continuous basis pursuant to Rule 415 under the Securities Act of
1933, other than securities offered only in connection with dividend or interest
reinvestment plans, check the following box. [X]
If this Form is filed to register additional securities for an offering
pursuant to Rule 462(b) under the Securities Act, please check the following box
and list the Securities Act registration statement number of the earlier
effective registration statement for the same offering. [ ] ___________________.
If this Form is a post-effective amendment filed pursuant to Rule 462(c)
under the Securities Act, check the following box and list the Securities Act
registration statement number of the earlier effective registration statement
for the same offering. [ ] _____________________
If delivery of the prospectus is expected to be made pursuant to Rule 434,
please check the following box. [ ]
CALCULATION OF REGISTRATION FEE
<TABLE>
<CAPTION>
- -----------------------------------------------------------------------------------------------------------------------
Title of each class of Proposed maximum Proposed maximum
securities to be Amount to be offering price per aggregate offering Amount of registration
registered registered unit (1) price (1) fee
- -----------------------------------------------------------------------------------------------------------------------
<S> <C> <C> <C> <C>
Common Stock, par
value $.01 per share 12,592,105 shares $0.234 $2,946,553 $869.23
- -----------------------------------------------------------------------------------------------------------------------
</TABLE>
(1) Estimated solely for purposes of determining the registration fee pursuant
to Rule 457(c), based upon the average of the closing bid and ask prices
for the Common Stock of $0.234 on February 20, 1998, as reported by The
Nasdaq SmallCap Market.
-------------------------------------
THE REGISTRANT HEREBY AMENDS THIS REGISTRATION STATEMENT ON SUCH DATE OR
DATES AS MAY BE NECESSARY TO DELAY ITS EFFECTIVE DATE UNTIL THE REGISTRANT SHALL
FILE A FURTHER AMENDMENT WHICH SPECIFICALLY STATES THAT THIS REGISTRATION
STATEMENT SHALL THEREAFTER BECOME EFFECTIVE IN ACCORDANCE WITH SECTION 8(A) OF
THE SECURITIES ACT OF 1933 OR UNTIL THE REGISTRATION STATEMENT SHALL BECOME
EFFECTIVE ON SUCH DATE AS THE COMMISSION, ACTING PURSUANT TO SAID SECTION 8(A),
MAY DETERMINE.
<PAGE> 3
PROSPECTUS
SALIVA DIAGNOSTIC SYSTEMS, INC.
12,592,105 SHARES OF COMMON STOCK
Saliva Diagnostic Systems, Inc. (the "Company") is registering for resale
up to 12,592,105 shares (the "Shares") of its common stock, $.01 par value (the
"Common Stock"), which include (i) 11,842,105 shares which may be issued upon
the conversion of 1,500 shares of the Company's 1998-A Convertible Preferred
Stock, par value $.01 per share (the "1998-A Preferred Stock"), and (ii) 750,000
shares which may be issued upon the exercise of warrants granted in connection
with the private placement of the 1998-A Preferred Stock (the "Warrants"). All
of the Common Stock offered hereby is being offered for the account of a
shareholder of the Company which acquired its securities in a private placement
conducted by the Company. See "Selling Shareholder." Additional shares that may
become issuable as a result of the anti-dilution provisions of the Warrants are
offered hereby pursuant to Rule 416 under the Securities Act of 1933, as amended
(the "Securities Act"). The Company will not receive any of the proceeds from
the sale of the Common Stock being offered hereby (the "Offering"), but will
receive the exercise price payable upon the exercise of the Warrants. There can
be no assurance that all or any part of the Warrants will be exercised or that
they will be exercised for cash.
The Shares may be sold from time to time in transactions (which may include
block transactions) on The Nasdaq SmallCap Market at the market prices then
prevailing. Sales of the Shares may also be made through negotiated transactions
or otherwise. The Selling Shareholder and the brokers and dealers through which
the sales of the Shares may be made may be deemed to be "underwriters" within
the meaning set forth in the Securities Act, and their commissions and discounts
and other compensation may be regarded as underwriters' compensation. See "Plan
of Distribution."
THE SECURITIES OFFERED HEREBY INVOLVE A HIGH DEGREE OF RISK AND SHOULD NOT
BE PURCHASED BY INVESTORS WHO CANNOT AFFORD THE LOSS OF THEIR ENTIRE INVESTMENT.
PROSPECTIVE PURCHASERS SHOULD CAREFULLY CONSIDER THE MATTERS DISCUSSED UNDER
"RISK FACTORS" BEGINNING ON PAGE 5.
-------------------------------------
THESE SECURITIES HAVE NOT BEEN APPROVED OR DISAPPROVED BY THE SECURITIES
AND EXCHANGE COMMISSION OR ANY STATE SECURITIES COMMISSION NOR HAS THE
SECURITIES AND EXCHANGE COMMISSION OR ANY STATE SECURITIES COMMISSION PASSED
UPON THE ACCURACY OR ADEQUACY OF THIS PROSPECTUS. ANY REPRESENTATION TO THE
CONTRARY IS A CRIMINAL OFFENSE.
-------------------------------------
<TABLE>
<CAPTION>
Price to Public(1) Proceeds to Selling Shareholder(1)(2)
------------------ -------------------------------
<S> <C> <C>
Per Share of Common Stock $0.25 $0.25
Total(3) $3,148,026.20 $3,148,026.20
</TABLE>
(1) Estimated based upon the average of the high and low sales prices for the
Common Stock on February 20, 1998, as reported by Nasdaq.
(2) Excludes regular brokerage commissions and other expenses, including
expenses of counsel for the Selling Shareholder, which will be paid by the
Selling Shareholder. The other expenses of the Offering are estimated to be
approximately $_________, all of which will be paid by the Company.
(3) Assumes all Shares registered will be issued to the Selling Shareholder and
will be sold in this Offering.
-------------------------------------
The date of this Prospectus is February __, 1998
<PAGE> 4
AVAILABLE INFORMATION
The Company is subject to the informational requirements of the Securities
Exchange Act of 1934, as amended (the "Exchange Act"), and in accordance
therewith, files reports and other information with the Securities and Exchange
Commission (the "Commission"). Such reports and other information can be
inspected and copied at the public reference facilities maintained by the
Commission at Room 1024, 450 Fifth Street, N.W., Washington, D.C. 20549; and the
Commission's regional offices at Room 1204, 219 South Dearborn Street, Chicago,
Illinois 60604; Room 1028, 7 World Trade Center, New York, New York 10007; and
Suite 500 East, 5757 Wilshire Boulevard, Los Angeles, California 90036. Copies
of such material can be obtained from the Public Reference Section of the
Commission, 450 Fifth Street, N.W., Washington, D.C. 20549 at prescribed rates.
The Commission maintains an internet web site that contains reports, proxy
statements and other materials filed electronically by the Company through the
Commission's Electronic Data, Gathering, Analysis and Retrieval (EDGAR) system.
This web site can be accessed at http://www.sec.gov. The Common Stock is traded
on The Nasdaq SmallCap Market ("Nasdaq") under the symbol "SALV," and copies of
reports and other information are also available for inspection at the Nasdaq
Stock Market, 1735 K Street, N.W., Washington, D.C. 20006.
The Company has filed with the Commission a Registration Statement on Form
S-3 (the "Registration Statement") under the Securities Act with respect to the
shares of Common Stock offered hereby. This Prospectus does not contain all of
the information set forth in the Registration Statement or the exhibits thereto.
As permitted by the rules and regulations of the Commission, this Prospectus
omits certain information contained or incorporated by reference in the
Registration Statement. For further information, reference is hereby made to the
Registration Statement and exhibits thereto, copies of which may be inspected at
the offices of the Commission at 450 Fifth Street, N.W., Washington, D.C. 20549
or obtained from the Commission at the same address at prescribed rates.
The Company furnishes Annual Reports to the holders of its securities which
contain financial information which have been examined and reported upon, with
an opinion expressed by, its independent certified public accountants.
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INFORMATION INCORPORATED BY REFERENCE
The following documents filed by the Company with the Commission pursuant
to the Exchange Act are incorporated herein by reference:
(1) Annual Report on Form 10-KSB for the fiscal year ended December 31,
1996, filed on March 31, 1997 (File No. 000-21284) pursuant to Section
13(a) of the Exchange Act, as amended on Form 10-KSB/A, filed on June
10, 1997 (File No. 000-21284) (the "1996 Annual Report");
(2) Quarterly Report on Form 10-QSB for the fiscal quarter ended March 31,
1997, filed on May 15, 1997 (File No. 000-21284) pursuant to Section
13(a) of the Exchange Act;
(3) Definitive Proxy Statement, filed on April 29, 1997 (File No.
000-21284) pursuant to Section 14(a) of the Exchange Act;
(4) Current Report on Form 8-K dated May 30, 1997, filed on May 30, 1997
(File No. 000-21284) pursuant to Section 13(a) of the Exchange Act, as
amended on Form 8-K/A dated May 30, 1997, filed on June 9, 1997 (File
No. 000-21284);
(5) Current Report on Form 8-K dated July 5, 1997, filed on July 30, 1997
(File No. 000-21284) pursuant to Section 13(a) of the Exchange Act;
(6) Quarterly Report on Form 10-QSB for the fiscal quarter ended June 30,
1997, filed on August 9, 1997 (File No. 000-21284) pursuant to Section
13(a) of the Exchange Act;
(7) Definitive Proxy Statement, filed on January 26, 1998 (File No.
000-21284) pursuant to Section 14(a) of the Exchange Act;
(8) Quarterly Report on Form 10-QSB for the fiscal quarter ended September
30, 1997, filed on November 14, 1997 (File No. 000-21284) pursuant to
Section 13(a) of the Exchange Act;
(9) Definitive Proxy Statement, filed on January 26, 1998 (File No.
000-21284) pursuant to Section 14(a) of the Exchange Act; and
(10) Current Report on Form 8-K dated January 26, 1998, filed on February
13, 1998 (File No. 000-21284) pursuant to Section 13(a) of the
Exchange Act.
All documents filed by the Company with the Commission pursuant to Sections
13(a), 13(c), 14 or 15(d) of the Exchange Act subsequent to the date hereof
shall hereby be deemed to be incorporated by reference in this Prospectus and to
be a part hereof from the date of filing of such documents. See "Available
Information." Any statement contained in a document incorporated or deemed to be
incorporated herein by reference shall be deemed to be modified or superseded
for
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<PAGE> 6
purposes of this Prospectus to the extent that a statement contained herein or
in any other subsequently filed document incorporated or deemed to be
incorporated herein by reference modifies or supersedes such statement. Any
statement contained herein shall be deemed to be modified or superseded for
purposes of this Prospectus to the extent that a statement contained in any
subsequently filed document incorporated or deemed to be incorporated herein by
reference 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 of this Prospectus.
THIS PROSPECTUS INCORPORATES DOCUMENTS BY REFERENCE WHICH ARE NOT PRESENTED
HEREIN OR DELIVERED HEREWITH. COPIES OF THESE DOCUMENTS (EXCLUDING EXHIBITS
UNLESS SUCH EXHIBITS ARE SPECIFICALLY INCORPORATED BY REFERENCE INTO THE
INFORMATION INCORPORATED HEREIN) WILL BE PROVIDED BY FIRST CLASS MAIL WITHOUT
CHARGE TO EACH PERSON TO WHOM THIS PROSPECTUS IS DELIVERED, UPON WRITTEN OR ORAL
REQUEST BY SUCH PERSON TO SHAREHOLDER RELATIONS, SALIVA DIAGNOSTIC SYSTEMS,
INC., 11719 NE 95TH STREET, VANCOUVER, WASHINGTON 98682 (TELEPHONE NUMBER (360)
696-4800).
No person has been authorized in connection with this offering to give any
information or to make any representation not contained or incorporated by
reference in this Prospectus and, if given or made, such information or
representation must not be relied upon as having been authorized by the Company,
the Selling Shareholder or any other person. This Prospectus does not constitute
an offer to sell, or a solicitation of an offer to purchase, any securities
other than those to which it relates, nor does it constitute an offer to sell or
a solicitation of an offer to purchase by any person in any jurisdiction in
which it is unlawful for such person to make such an offer or solicitation.
Neither the delivery of this Prospectus nor any sale made hereunder shall under
any circumstances create any implication that the information contained herein
is correct as of any time subsequent to the date hereof.
CAUTIONARY STATEMENT
THIS PROSPECTUS, AS WELL AS INFORMATION INCORPORATED BY REFERENCE HEREIN,
CONTAINS FORWARD-LOOKING STATEMENTS, WITHIN THE MEANING OF THE PRIVATE
SECURITIES LITIGATION REFORM ACT OF 1995. FORWARD-LOOKING STATEMENTS INCLUDE,
BUT ARE NOT LIMITED TO, THOSE STATEMENTS RELATING TO DEVELOPMENT OF NEW
PRODUCTS, THE ABILITY TO OBTAIN NEW DISTRIBUTION AGREEMENTS AND INCREASE
DISTRIBUTION FOR PRODUCTS UNDER EXISTING DISTRIBUTION AGREEMENTS, APPROVAL OF
THE COMPANY'S PRODUCTS AS AND WHEN REQUIRED BY THE FOOD AND DRUG ADMINISTRATION
("FDA") IN THE UNITED STATES AND SIMILAR REGULATORY BODIES IN OTHER COUNTRIES,
AND THE SCALE-UP OF MANUFACTURING IN THE UNITED STATES AND ATTENDANT FDA
APPROVALS. THESE FORWARD-LOOKING STATEMENTS ARE SUBJECT TO THE BUSINESS AND
ECONOMIC RISKS FACED BY THE COMPANY AND THE COMPANY'S ACTUAL RESULTS COULD
DIFFER MATERIALLY FROM THOSE ANTICIPATED IN THESE FORWARD-LOOKING STATEMENTS AS
A RESULT OF CERTAIN FACTORS, INCLUDING THOSE SET FORTH UNDER "RISK FACTORS"
BELOW, UNDER "ITEM 1 - BUSINESS" AND "ITEM 6 - MANAGEMENT'S
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DISCUSSION AND ANALYSIS OR PLAN OF OPERATION" IN THE 1996 ANNUAL REPORT, AND IN
THE OTHER DOCUMENTS INCORPORATED BY REFERENCE HEREIN.
RISK FACTORS
The securities offered hereby are speculative and involve a high degree of
risk, including, but not limited to, the risk factors described below. Each
prospective investor should carefully consider the following risk factors
inherent in and affecting the business of the Company and this offering before
making an investment decision.
1. Limited Operating History. Since July 1990, the Company has been
engaged primarily in research and development activities focused on developing
proprietary collection devices and rapid assays. To date, sales of the Company's
products have been to a limited customer base. The Company has a limited
operating history upon which an evaluation of the Company's prospects can be
made. Such prospects must be considered in light of the risks, expenses and
difficulties frequently encountered in the establishment of a new business in a
continually evolving, heavily regulated industry, characterized by an increasing
number of market entrants and intense competition, as well as the risks,
expenses and difficulties encountered in the shift from development to
commercialization of new products based on innovative technology. There can be
no assurance that the Company will be able to implement successfully its
marketing strategy, obtain necessary regulatory approval, generate increased
revenues or ever achieve profitable operations.
2. Significant Operating Losses; Accumulated Deficit; Explanatory
Paragraph in Report of Independent Certified Public Accountants. The Company has
incurred significant operating losses since its inception, resulting in an
accumulated deficit of $21,914,246 and $25,742,171 at December 31, 1996 and
September 30, 1997, respectively, and a shareholders' equity of $1,160,632 and
$1,283,666 at December 31, 1996 and September 30, 1997, respectively. The
Company has incurred additional operating losses through the date of this
Prospectus. Such losses are expected to continue for the foreseeable future and
until such time, if ever, as the Company is able to attain sales levels
sufficient to support its operations. The Company's independent certified public
accountants have included an explanatory paragraph in their report stating that
the Company's significant operating losses and significant capital requirements
raise substantial doubt about the Company's ability to continue as a going
concern.
3. Significant Capital Requirements; Need for Additional Financing. The
Company's capital requirements have been and will continue to be significant.
The Company has been dependent on private placements of its debt and equity
securities and on a public offering of securities in March 1993 to fund such
requirements. The Company is dependent upon its other efforts to raise capital
resources, including proceeds received from the exercise of warrants, to finance
the costs of manufacturing, marketing and conducting clinical trials and
submissions for FDA approval of its products and continuing the design and
development of the Company's new products. Marketing, manufacturing and clinical
testing may require capital resources substantially greater than the resources
currently available to the Company. There can
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<PAGE> 8
be no assurance that the Company will be able to obtain additional capital
resources necessary to permit the Company to implement or continue its programs.
There can be no assurance that such financing will be available on commercially
reasonable terms or at all. Any additional equity financing may involve
substantial dilution to the interests of the Company's shareholders, which
dilution also has occurred in the past.
4. Possible Removal of Securities from Nasdaq System; Disclosure
Relating to Low-Priced Stocks. The Company may be unable to maintain the
standards for continued quotation on Nasdaq and the Common Stock could be
subject to removal from the Nasdaq system.
By letter dated October 27, 1997, Nasdaq informed the Company that its
Common Stock would be removed from The Nasdaq SmallCap Market if the current
continued listing requirements were not met prior to January 27, 1998. At that
time, the Nasdaq continued listing requirements included maintaining a common
stock minimum closing bid price of $1.00 or, alternatively, maintaining capital
and surplus of $2,000,000 and a market value of the public float of $1,000,000.
Under the current Nasdaq continued listing requirements, which were effective on
February 23, 1998, the Company is required to maintain a $1.00 minimum bid price
and one of the following: net tangible assets of $2,000,000, market
capitalization of $35,000,000 or net income of $50,000 in the most recently
completed fiscal year or in two of the last three most recently completed fiscal
years. Continued inclusion also requires a $1,000,000 market value of the public
float, two market-makers and a minimum bid price of $1.00 per share without
exception.
On January 27, 1998, the Company submitted to Nasdaq a formal request for a
hearing on written submission to consider the Company's plan for meeting the
continued listing requirements. Nasdaq granted such request and stayed the
delisting action until the hearing, which is scheduled for February 26, 1998. On
February 11, 1998, the Company submitted its plan of compliance for
consideration at the hearing. There can be no assurance that Nasdaq will accept
the Company's plan of compliance or that the Common Stock will not be delisted
from The Nasdaq SmallCap Market.
If the Company is removed from the Nasdaq system, trading, if any, in the
Common Stock would thereafter be conducted in the over-the-counter market on an
electronic bulletin board established for securities that do not meet the Nasdaq
inclusion requirements or in what are commonly referred to as the "pink sheets".
As a result, an investor would find it more difficult to dispose of, or to
obtain accurate quotations as to the price of, the Company's securities. In
addition, if the Company's securities were removed from the Nasdaq system, they
would be subject to so-called "penny stock" rules that impose additional sales
practice requirements on broker-dealers who sell such securities. Consequently,
removal from the Nasdaq system, if it were to occur, could affect the ability or
willingness of broker-dealers to sell the Company's securities and the ability
of purchasers of the Company's securities to sell their securities in the
secondary market. There is no assurance that the Company will continue to remain
eligible for continued inclusion of the Common Stock on Nasdaq.
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<PAGE> 9
5. Uncertain Acceptance of Saliva-Based Tests and Rapid Tests as
Diagnostic Tools. The human specimens traditionally used for the diagnostic
testing and quantitative measurement of most physiologically active substances,
drugs and toxins in the body, are blood and urine. Substantially all of the
assay-based diagnostic test kits currently available were approved by the FDA
for use with these testing specimens. Political and social factors may create
impediments to the use of rapid tests as diagnostic tools. These factors include
whether certain diagnostic tests, such as HIV antibody tests, should be
conducted without trained specialists and whether rapid tests in nontraditional
testing environments will lead to invasions of privacy. Although the Company
acknowledges the existence of such considerations, it is committed to developing
rapid testing devices as useful diagnostic tools. Limitations on the Company's
ability to market rapid tests caused by political and social factors could have
a material adverse effect on the Company's operations.
6. Uncertainty of New Product Development. The design and development of
the Company's rapid testing platforms in their current designs have been
completed and limited revenues have been generated from sales thereof. The
Company will be required to devote considerable additional efforts to finalize
the evaluation of its products. Satisfactory completion of development, testing,
evaluations, obtaining regulatory approvals and achieving sufficient production
levels of such products will be required prior to their being available for
commercial sale. The Company's products remain subject to all the risks inherent
in the introduction of new diagnostic products, including unanticipated
problems, as well as the possible insufficiency of funds to continue design and
development which could result in abandonment of or substantial change in the
design or development of such products. There can be no assurance that such
products will be successfully developed, be developed on a timely basis or prove
to be as effective as products based on existing or newly developed
technologies. The inability to successfully complete development, or a
determination by the Company, for financial or other reasons, not to undertake
to complete development of any product, particularly in instances in which the
Company has made significant capital expenditures, could have a material adverse
effect on the Company.
7. Competition. The market in which the Company operates, saliva and
blood-based collection and diagnostic testing, is highly competitive. The
Company is aware of certain entities, including ChemTrak, Inc., Epitope, Inc.,
Quidel, Inc. and Trinity Biotech, plc and specialized biotechnology firms, as
well as universities and other research institutions, which have developed or
are developing technologies and products which are competitive with Omni-SAL(R)
and the Company's products under development. Many of these competitors are
established and have substantially greater research, marketing and financial
resources than the Company. The Company expects that the number of products
competing with its products will increase as the perceived benefits of
saliva-based testing become more widely recognized. There can be no assurance
the Company will be able to compete successfully.
8. Technological Change and Risk of Technological Obsolescence. The
biotechnology industry and, in particular, saliva and blood-based diagnostic
testing, is subject to rapid and significant technological change. There can be
no assurance that the Company's
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<PAGE> 10
competitors will not succeed in developing technologies and products relating to
the collection of saliva for diagnostic testing prior to the Company or that
they will not develop technologies and products that are more effective than any
which have been or are being developed by the Company. In addition, the
diagnostic products market is characterized by changing technology and
developing industry standards sometimes resulting in product obsolescence or
short product life cycles. Accordingly, the ability of the Company to compete
will be dependent on its introducing products to the marketplace in a timely
manner and enhancing and improving such products. There can be no assurance that
the Company will be able to keep pace with technological developments or that
its products will not become obsolete.
9. Government Regulation. The development, manufacture and sale of the
Company's products in the United States are subject to regulation by the FDA and
other governmental agencies. The process of obtaining FDA approval is costly and
time-consuming, and there can be no assurance that any of the Company's products
not yet approved will be approved by the FDA or other regulatory agencies.
Delays in obtaining regulatory approvals may adversely affect the development,
testing or marketing of the Company's products and the ability of the Company to
generate product revenues therefrom. If and when the Company's products are
approved by the FDA, they will be subject to continuing regulation by the FDA
and state and local agencies. The FDA has established a number of requirements
for manufacturers and requirements regarding labeling and reporting. The failure
to comply with these requirements can result in regulatory action, including
warning letters, product seizure, injunction, product recalls, civil fines and
prosecution. An FDA enforcement action could have a material adverse effect on
the Company. The Company is subject to regulation in certain foreign markets.
There can be no assurance that regulatory approvals for any of the Company's
products or for its manufacturing in the United States will be obtained in a
timely manner, or at all.
10. Risks Related to Foreign Activities. The Company and its
manufacturers may be subject to various import duties imposed by foreign
governments applicable to both finished products and components and may be
affected by various other import and export restrictions or duties as well as
other developments having an impact upon international trade. These factors
could, under certain circumstances, have an impact both on the manufacturing
cost and the wholesale and retail prices of such products. To the extent that
transactions relating to foreign sales, manufacturing of the Company's products
and purchases of components involve currencies other than United States dollars,
the operating results of the Company could be adversely affected by fluctuations
in foreign currency exchange rates.
11. Uncertainty of Market Acceptance; Dependence Upon Third Party
Distributors. The Company has limited marketing capabilities and resources.
Achieving market acceptance will require substantial marketing efforts and the
expenditure of significant funds to inform potential consumers and the public of
the perceived benefits of the Company's current and proposed products. Moreover,
the Company does not have the financial or other resources to undertake
extensive marketing and advertising activities. The Company has recently begun
to develop strategic alliances and marketing arrangements, including joint
ventures, license or distribution arrangements. The Company's prospects will be
significantly affected by its ability to successfully develop and maintain its
relationships with its joint venturers, licensors and
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<PAGE> 11
distributors and upon the marketing efforts of such third parties. While the
Company believes that any independent distributors and sales representatives
with whom it enters into such arrangements will have an economic motivation to
commercialize the Company's products, the time and resources devoted to those
activities generally will be controlled by such entities and not by the Company.
There can be no assurance that the Company will be able, for financial or other
reasons, to develop and maintain any third party distribution or marketing
arrangements or that such arrangements, if established, will result in the
successful commercialization of any of the Company's products.
12. Dependence on Manufacturers. The Company relies on arrangements with
third parties for the manufacture of some of its products. Such manufacturers,
if located in the United States or if manufacturing products to be sold in the
United States, must comply with the FDA's good manufacturing practices ("GMP")
and pass pre-approval inspections by the FDA and periodic GMP inspections. MML
Diagnostic Packaging, Inc. ("MML") manufactures Omni-Swab and Saliva*Sampler for
the Company in the United States and has advised the Company that it is in
compliance with all applicable FDA requirements for such manufacturing. There
can be no assurance that the Company's manufacturer will continue to comply with
GMP, that the Company will be able to locate additional manufacturers that
comply with GMP or secure agreements with such manufacturers on terms acceptable
to the Company. There can be no assurance that MML will be able to meet the
Company's requirements or that MML will continue to manufacture Omni-Swab or
Saliva*Sampler on terms acceptable to the Company.
13. Dependence Upon Third-Party Suppliers. The Company believes that
most of the components used in the manufacture of its proposed products are
currently available from numerous suppliers located in the United States, Europe
and Asia. The Company believes, however, that certain components are available
from a limited number of suppliers. Although the Company believes that it will
not encounter difficulties in obtaining these components, there can be no
assurance that the Company will be able to enter into satisfactory agreements or
arrangements for the purchase of commercial quantities of such components. The
failure to enter into agreements or otherwise arrange for adequate or timely
supplies of components and the possible inability to secure alternative sources
of components could have a material adverse effect on the Company's ability to
manufacture its products. In addition, development and regulatory approval of
the Company's products in the United States are dependent upon the Company's
ability to procure certain components and certain packaging materials from
FDA-approved sources. Since the FDA approval process requires manufacturers to
specify their proposed suppliers of certain components in their premarket
approval applications ("PMAs"), if any such component were no longer available
from the specified supplier, FDA approval of a new supplier would be required,
resulting in potential manufacturing delays.
14. Dependence on Small Number of Customers. The Company derives a large
portion of its revenues from sales to a small number of customers. Sales to
three customers accounted for approximately 49% of total product revenues in
1996. Sales to two customers accounted for approximately 50% of total product
revenues in 1995. The loss of sales to any of
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the Company's major customers could have a material adverse effect on the
Company's financial condition and results of operations.
15. Dependence on Key Personnel. The success of the Company will be
largely dependent on the personal efforts of Kenneth J. McLachlan, its President
and Chief Executive Officer, and certain key management and scientific
personnel. The loss of Mr. McLachlan's services or the services of other key
management or scientific personnel would have a material adverse effect on the
Company's business and prospects. Competition among biotechnology companies for
qualified employees is intense, and the loss of key personnel or the inability
to attract and retain the additional highly skilled employees required for the
Company's activities could adversely affect its business. There can be no
assurance that the Company will be able to hire or retain such necessary
personnel.
16. Uncertainty of Patent Protection; Proprietary Information. The
Company has applied for United States patents on certain aspects of its saliva
collection and diagnostic testing devices and has been awarded eight of these
patents. To the extent possible, the Company also anticipates filing patent
applications for protection on future products and technology which it develops.
There can be no assurance that patents applied for will be obtained, that any
such patents will afford the Company commercially significant protection of its
technology or that the Company will have adequate resources to enforce its
patents. Inasmuch as the Company intends to sell its products in foreign
markets, it is in the process of seeking foreign patent protection on its
current products and technologies. The patent laws of other countries may differ
from those of the United States as to the patentability of the Company's
products and technologies and the degree of protection afforded. Other companies
may independently develop equivalent or superior products and technologies and
may obtain patent or similar rights with respect thereto. Although the Company
believes that its products and technologies have been independently developed
and do not infringe on the patents of others, there can be no assurance that the
Company's products and technologies do not and will not infringe on the patents
of others. In the event of infringement, the Company would, under certain
circumstances, be required to modify its device or obtain a license. There can
be no assurance that the Company will be able to do either of the foregoing in a
timely manner or upon acceptable terms and conditions, and the failure to do so
could have a material adverse effect on the Company. There can be no assurance
that the Company will have the financial or other resources necessary to
successfully defend a claim of violation of proprietary rights.
17. Product Liability; Insurance Coverage. The Company may be exposed to
potential product liability claims by consumers. The Company maintains product
liability insurance coverage in an amount up to $4,000,000 per occurrence, up to
a maximum of $4,000,000 in the aggregate, with excess umbrella liability
insurance coverage of $4,000,000. In the event of a product liability claim,
there can be no assurance that such insurance will be sufficient to cover all
possible liabilities. In the event of a successful suit against the Company,
insufficiency of insurance coverage would have a material adverse effect on the
Company.
18. No Dividends. To date, the Company has not paid any dividends on its
Common Stock and does not expect to declare or pay any dividends in the
foreseeable future.
10
<PAGE> 13
19. Significant Outstanding Options and Warrants. As of February __,
1998, there were outstanding (i) stock options to purchase an aggregate of
3,097,915 shares of Common Stock at exercise prices ranging from $0.40 to $5.50
per share; (ii) warrants to purchase 1,380,000 shares of Common Stock which were
issued in the Company's initial public offering, are exercisable at $1.25 per
share, and expire March 31, 1998, unless extended by the Company; and (iii)
warrants to purchase 1,284,184 shares which are exercisable at prices ranging
from $0.3375 to $4.00 per share.
To the extent that outstanding options or warrants are exercised, dilution
to the Company's shareholders will occur. Moreover, the terms upon which the
Company will be able to obtain additional equity capital may be adversely
affected since the holders of outstanding options and warrants can be expected
to exercise them at a time when the Company would, in all likelihood, be able to
obtain any needed capital on terms more favorable to the Company than the
exercise terms provided by such outstanding securities.
20. Litigation. In January 1997, a lawsuit was filed by Ronald Lealos,
the former President of the Company, who resigned in December 1996. The
complaint in the lawsuit alleged various breach of contract claims. This lawsuit
was dismissed without prejudice as a prerequisite to a settlement agreement
between Mr. Lealos and the Company. No final settlement acceptable to the
Company has yet been concluded with Mr. Lealos. New litigation may ensue and, if
such litigation is decided adverse to the Company, there can be no assurance
that it would not have a material adverse effect on the Company.
The Company is also currently involved in litigation brought by Luc Hardy
against the Company and former officer and directors, Ronald Lealos and Eugene
Seymour, and Richard Kalin. This matter involves allegations against the Company
and the individual defendants arising from Mr. Hardy's termination by the
Company in 1994. A jury verdict for the plaintiff, which is not a final
judgment, was rendered on July 25, 1997 in the approximate amount of $740,000.
In October 1997, a hearing was held on the Company's motions to set aside the
jury verdict and for a new trial. The Company is currently awaiting a decision.
There can be no assurance such motions will be granted or that the final
judgment in this case will not have a material adverse effect on the Company.
In April 1996, Meritxell Ltd. filed a complaint against the Company
involving a dispute with respect to the conversion rate of a convertible
debenture issued to Merixell by the Company. In February 1997, the Company's
motion for summary judgment was granted and the lawsuit was dismissed.
THE COMPANY
The Company is primarily engaged in the development, manufacturing and
marketing of rapid in vitro assays for use in the detection of infectious
diseases and other conditions, proprietary specimen collection devices and other
diagnostic devices. The Company's principal
11
<PAGE> 14
executive offices are located at 11719 NE 95th Street, Vancouver, Washington,
98682 and its telephone number is (360) 696-4800.
The Company develops rapid immunoassays utilizing immunochromatography for
the detection of antibodies to selected pathogens, such as the HIV, the virus
that causes AIDS, and Helicobacter pylori, a bacteria linked to peptic ulcers
and gastric cancer. The Company's immunoassays are designed to require only a
few simple steps and minutes to use. The tests produce visual results in under
20 minutes, and may be used without special equipment, storage or training. The
Company's data and independent evaluations demonstrate that its Hema*Strip HIV
and Sero*Strip HIV tests are generally equivalent in performance to widely used
FDA-licensed tests for HIV.
To date, the Company has developed three rapid HIV tests: Sero*Strip HIV,
Hema*Strip HIV and Saliva*Strip HIV, and a rapid H. pylori test: Stat*Simple.
The Company has under development rapid tests for hepatitis and tuberculosis.
The Company has commenced production and marketing of two medical specimen
collectors: Saliva*Sampler and Omni-Swab. In addition, the Company has conducted
preliminary research that indicates its rapid test format may be expanded to
detect other diseases, such as tuberculosis, measles, malaria, rubella, tetanus,
herpes, chlamydia, mumps, influenza, parvovirus, pertussis, certain cancers,
tumor markers and cardiac disease.
SELLING SHAREHOLDER
The Selling Shareholder is Biscount Overseas Limited ("Biscount"), the
purchaser of 1,500 shares of the Company's 1998-A Convertible Preferred Stock,
par value $0.01 per share (the "1998-A Preferred Stock"), for an aggregate
purchase price of $1,500,000, and the owner of warrants to purchase 750,000
shares of Common Stock (the "Warrants") acquired by Biscount in connection with
the private placement of the 1998-A Preferred Stock.
All of the Shares that may be acquired by the Selling Shareholder upon
conversion of the 1998-A Preferred Stock or exercise of the Warrants are being
registered pursuant to the Registration Statement of which this Prospectus forms
a part, and are being offered hereby.
The Company will not receive any proceeds from the sale of the Shares by
the Selling Shareholder. Sale of any shares of Common Stock by the Selling
Shareholder, or even the existence of the right to acquire shares of Common
Stock by reason of the 1998-A Preferred Stock, or to acquire shares of Common
Stock upon the exercise of the Warrants, may depress the price of the Common
Stock.
Of the Shares offered hereby, 11,842,105 are issuable upon the conversion
of 1,500 shares of the 1998-A Preferred Stock and 750,000 are issuable upon the
exercise of the Warrants. Upon conversion of the 1998-A Preferred Stock, the
holder will be entitled to receive a number of shares of Common Stock determined
by dividing the stated value of the 1998-A Preferred
12
<PAGE> 15
Stock ($1,000 per share), plus a dividend in the amount of 6% per annum of the
stated value from the date of issuance (unless the Company elects to pay that
dividend in cash), by a conversion price equal to the lesser of $.3375 or 20% of
the average closing bid prices for shares of the Common Stock during the
five-day period prior to conversion, subject to adjustment upon the occurrence
of certain dilutive events. A holder of the 1998-A Preferred Stock may convert
up to (i) twenty-five percent (25%) of the shares of 1998-A Preferred Stock
initially issued to the holder at any time from and after April 26,1998, (ii)
fifty percent (50%) of the shares of 1998-A Preferred Stock from and after May
26, 1998, (iii) seventy-five percent (75%) of the shares of 1998-A Preferred
Stock from and after June 25, 1998, and (iv) all of the shares of 1998-A
Preferred Stock from and after July 25, 1998. The Warrants are exercisable at a
price of $0.3375 per share at any time on or prior to January 26, 2003.
The foregoing summary is qualified in its entirety by the terms of the
1998-A Preferred Stock and the Warrants.
The Selling Shareholder is not an affiliate of the Company and has had no
position, office or other material relationship with the Company within the past
three years, except that Aryeh Trading, Inc., an affiliate of the Selling
Shareholder, received a cash fee of $112,500 for assisting the Company in the
1998-A Preferred Stock private placement.
PLAN OF DISTRIBUTION
The Selling Shareholder may sell the shares in one or more transactions
(which may involve one or more block transactions) on the over-the-counter
markets on Nasdaq and upon terms then prevailing or at prices related to the
then current market price, or in separately negotiated transactions or in a
combination of such transactions. The Common Stock offered hereby may be sold by
one or more of the following methods, without limitation: (a) a block trade in
which a broker or dealer so engaged will attempt to sell the shares as agent but
may position and resell a portion of the block as principal to facilitate the
transaction; (b) purchases by a broker or dealer as principal and resale by such
broker or dealer for its account pursuant to this Prospectus; (c) ordinary
brokerage transactions and transactions in which the broker solicits purchasers;
(d) privately negotiated transactions; (e) short sales; and (f) face-to-face
transactions between sellers and purchasers without a broker-dealer. The Selling
Shareholder may also sell Shares in accordance with Rule 144 under the
Securities Act. The Selling Shareholder may be deemed to be an underwriter of
the shares offered hereby within the meaning of the Securities Act.
The Company has agreed to keep effective the registration of the Shares
offered hereby for a period of not less than two years, until the date upon
which all of the Shares offered hereby have been sold or until the date on which
the Shares may be sold without registration, whichever is shorter.
13
<PAGE> 16
In effecting sales, brokers or dealers engaged by the Selling Shareholder
may arrange for other brokers or dealers to participate. Such broker or dealers
may receive commissions or discounts from the Selling Shareholder in amounts to
be negotiated. All other expenses incurred in connection with this offering will
be borne by the Company other than the Selling Shareholder's legal fees. Such
brokers and dealers and any other participating brokers or dealers may, in
connection with such sales, be deemed to be underwriters within the meaning of
the Securities Act. Any discounts or commissions received by any such brokers or
dealers may be deemed to be underwriting discounts and commissions under the
Securities Act.
The Company is bearing all of the costs relating to registration of the
Shares, except commissions, discounts or other fees payable to a broker, dealer,
underwriter, agent or market maker in connection with the sale of any of the
Shares and fees of counsel for the Selling Shareholder.
LEGAL MATTERS
The validity of the securities being offered will be passed upon for the
Company by Bryan Cave LLP, 700 Thirteenth Street, Washington, D.C. 20005.
EXPERTS
The financial statements of the Company for the fiscal years ended December
31, 1996 and 1995 have been audited by Hollander, Gilbert & Co., independent
certified public accountants, to the extent and for the periods set forth in
their report with respect thereto, and are included the Company's Annual Report
on Form 10-KSB for the fiscal year ended December 31, 1996, and are incorporated
herein by reference, in reliance upon such report given upon the authority of
said firm as experts in auditing and accounting.
14
<PAGE> 17
No dealer, sales representative or other individual has been authorized to
give any information or make any representation not contained in this Prospectus
in connection with this offering other than those contained in this Prospectus
and if given or made, such information or representation must not be relied upon
as having been authorized by the Company. This Prospectus does not constitute an
offer to sell or solicitation of an offer to buy the Common Stock by 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 any person to whom it is unlawful to make such offer or solicitation. Neither
the delivery of this Prospectus nor any sale made hereunder shall under any
circumstances create an implication that the information contained herein is
correct as of any time subsequent to its date.
TABLE OF CONTENTS
<TABLE>
<CAPTION>
Page
<S> <C>
Available Information.............................................2
Information Incorporated By Reference.............................3
Cautionary Statement..............................................4
Risk Factors......................................................5
The Company......................................................11
Selling Shareholder..............................................12
Plan of Distribution.............................................13
Legal Matters....................................................14
Experts..........................................................14
</TABLE>
Until April __, 1998 (40 days after the date of the Prospectus), all
dealers effecting transactions in the registered securities, whether or not
participating in this distribution, may be required to deliver a Prospectus.
This delivery requirement is in addition to the obligation of dealers to deliver
a Prospectus when acting as Underwriter and with respect to their unsold
allotments or subscriptions.
SALIVA DIAGNOSTIC SYSTEMS, INC.
12,592,105 SHARES OF COMMON STOCK
PROSPECTUS
FEBRUARY __, 1998
<PAGE> 18
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
ITEM 14. OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION.
The expenses in connection with the issuance and distribution of the
securities being registered hereby will be borne by the Company and are
estimated to be as follows:
<TABLE>
<S> <C>
Registration Fee............................................... $869.23
Legal Fees..................................................... _________*
Accounting Fees................................................ _________*
Total..................................................... _________*
</TABLE>
- -------------------
* Estimated
ITEM 15. INDEMNIFICATION OF DIRECTORS AND OFFICERS.
Section 145 of the Delaware General Corporation Law empowers a corporation
to indemnify its directors and officers and to purchase insurance with respect
to liability arising out of their capacity or status as directors and officers
provided that this provision shall not eliminate or limit the liability of a
director (i) for any breach of the director's duty of loyalty to the Corporation
or its stockholders, (ii) for acts or omissions not in good faith or which
involve intentional misconduct or a knowing violation of law, (iii) arising
under Section 174 of the General Corporation Law of Delaware, or (iv) for any
transaction from which the director derived an improper personal benefit.
The Delaware Corporation Law provides further that the indemnification
permitted thereunder shall not be deemed exclusive of any other rights to which
the directors and officers may be entitled under the corporation's by-laws, any
agreement, vote of shareholders or otherwise.
Article Ten of the Company's Certificate of Incorporation eliminates the
personal liability of directors to the fullest extent permitted by Section 145
of the Delaware Corporation Law.
The effect of the foregoing is to require the Company to indemnify the
officers and directors of the Company for any claim arising against such persons
in their official capacities if such person acted in good faith and in a manner
that 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.
<PAGE> 19
INSOFAR AS INDEMNIFICATION FOR LIABILITIES ARISING UNDER THE SECURITIES ACT
OF 1933 MAY BE PERMITTED TO DIRECTORS, OFFICERS OR PERSONS CONTROLLING THE
COMPANY PURSUANT TO THE FOREGOING PROVISIONS, THE COMPANY HAS BEEN INFORMED 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.
ITEM 16. EXHIBITS.
<TABLE>
<CAPTION>
Exhibit Description
- ------- -----------
<S> <C>
4.1 Specimen of Certificate Representing Common Stock, incorporated by
reference to Exhibit 4.1 to the Company's Registration Statement on Form
S-1 (Registration No. 33-46648)
4.2 Certificate of Designations, Rights and Preferences of the Series 1998-A
Convertible Preferred Stock, incorporated by reference to Exhibit 4.1 of
the Company's Current Report on Form 8-K, dated January 26, 1998 (File No.
000-21284)
4.3 Warrant dated as of January 26, 1998 issued to Biscount Overseas Limited*
5 Opinion of Bryan Cave LLP*
10.1 Securities Purchase Agreement dated as of January 26, 1998 between the
Company and Bicount Overseas Limited, incorporated by reference to Exhibit
10.1 of the Company's Current Report on Form 8-K, dated January 26, 1998
(File No. 000-21284)
10.2 Registration Rights Agreement dated as of January 26, 1998 between the
Company and Biscount Overseas Limited, incorporated by reference to Exhibit
10.2 of the Company's Current Report on Form 8-K, dated January 26, 1998
(File No. 000-21284)
10.4 Placement Agent Agreement dated as of January 26, 1998 between the Company
and Aryeh Trading, Inc., incorporated by reference to Exhibit 10.3 of the
Company's Current Report on Form 8-K, dated January 26, 1998 (File No.
000-21284)
23.1 Consent of Hollander, Gilbert & Co.*
23.2 Consent of Bryan Cave LLP (included in Exhibit 5)
</TABLE>
- ------------------------
* To be filed by amendment
II-2
<PAGE> 20
ITEM 17. UNDERTAKINGS
(a) Insofar as indemnification for liabilities arising under the
Securities Act of 1933, may be permitted to directors, officers and controlling
persons of the Company pursuant to the foregoing provisions or otherwise, the
Company 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 Company
of expenses incurred or paid by a director, officer or controlling person of the
Company 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 Company 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 of 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.
(b) The Company hereby undertakes:
(1) To file, during any period in which offers or sales are being made,
a post-effective amendment to this Registration Statement to:
(i) include any prospectus required by Section 10 (a)(3) of the
Securities Act;
(ii) reflect in the prospectus any facts or events arising after the
effective date of this 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 this Registration Statement;
(iii) include any material information with respect to the plan of
distribution not previously disclosed in this Registration Statement or any
material change to such information in this 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.
(4) For purposes of determining any liability under the Securities Act,
the information omitted from the form of Prospectus filed as part of a
Registration Statement in reliance upon Rule 430A and contained in the form of
Prospectus filed by Registrant pursuant to Rule 424 (b)(1) or (4) under the
Securities Act shall be deemed to be part of the Registration Statement as of
the time it was declared effective.
II-3
<PAGE> 21
(5) For the purpose of determining any liability under the Securities
Act, each post-effective amendment that contains a form of Prospectus shall be
deemed to be a new Registration Statement relating to the securities offered
therein, and the offering of such securities at that time shall be deemed to be
the initial bona fide offering thereof.
II-4
<PAGE> 22
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, as amended, the
registrant certifies that it has reasonable grounds to believe that it meets all
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 Vancouver, State of Washington, on February __, 1998.
SALIVA DIAGNOSTIC SYSTEMS, INC.
By: /s/ Kenneth J. McLachlan
-------------------------
Kenneth J. McLachlan
President and Chief Executive Officer
Pursuant to the requirements of the Securities Act of 1933, as amended,
this Registration Statement has been signed below by the following persons in
the capacities and on the dates indicated. Each of such persons appoints Kenneth
J. McLachlan and Eric F. Stoer or each of them with full power to act without
the other, his true and lawful attorneys-in-fact and agents for him and on his
behalf and in his name, place and stead, and in any and all capacities, with
full and several right of substitution, to sign and file with the proper
authorities any and all documents in connection with the Registration Statement,
filed with the Securities and Exchange Commission on February __, 1998, granting
unto said attorneys, and each of them, full power and authority to do and
perform each and every act and thing requisite and necessary to be done in and
about the premises in order to effectuate the same as fully to all intents and
purposes as he might or could do if personally present, hereby ratifying and
confirming all that said attorneys-in-fact and agents, or any of them, may
lawfully do or cause to be done by virtue hereof.
<TABLE>
<CAPTION>
SIGNATURE TITLE DATE
<S> <C> <C>
/s/ Kenneth J. McLachlan Director, President, Chief Executive February __, 1998
- ------------------------ Officer, Chief Financial Officer and
Kenneth J. McLachlan Chief Accounting Officer
/s/ Eric F. Stoer Director February __, 1998
- -----------------
Eric F. Stoer
/s/ Hans R. Vauthier Director February __, 1998
- --------------------
Hans R. Vauthier
/s/ Paul D. Slowey Chief Operating Officer and February __, 1998
- ------------------ Vice President of Marketing
Paul D. Slowey
/s/ Deloris Schneider Vice President of Finance and February __, 1998
- --------------------- Vice President of Operations
Deloris Schneider
</TABLE>
<PAGE> 23
SALIVA DIAGNOSTIC SYSTEMS, INC.
EXHIBIT INDEX
<TABLE>
<CAPTION>
Exhibit Description
- ------- -----------
<S> <C>
4.1 Specimen of Certificate Representing Common Stock, incorporated by
reference to Exhibit 4.1 to the Company's Registration Statement on Form
S-1 (Registration No. 33-46648)
4.2 Certificate of Designations, Rights and Preferences of the Series 1998-A
Convertible Preferred Stock, incorporated by reference to Exhibit 4.1 of
the Company's Current Report on Form 8-K, dated January 26, 1998 (File No.
000-21284)
4.3 Warrant dated as of January 26, 1998 issued to Biscount Overseas Limited*
5 Opinion of Bryan Cave LLP*
10.1 Securities Purchase Agreement dated as of January 26, 1998 between the
Company and Bicount Overseas Limited, incorporated by reference to Exhibit
10.1 of the Company's Current Report on Form 8-K, dated January 26, 1998
(File No. 000-21284)
10.2 Registration Rights Agreement dated as of January 26, 1998 between the
Company and Biscount Overseas Limited, incorporated by reference to Exhibit
10.2 of the Company's Current Report on Form 8-K, dated January 26, 1998
(File No. 000-21284)
10.4 Placement Agent Agreement dated as of January 26, 1998 between the Company
and Aryeh Trading, Inc., incorporated by reference to Exhibit 10.3 of the
Company's Current Report on Form 8-K, dated January 26, 1998 (File No.
000-21284)
23.1 Consent of Hollander, Gilbert & Co.*
23.2 Consent of Bryan Cave LLP (included in Exhibit 5)
</TABLE>
- ---------------------
* To be filed by amendment
