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AS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION ON DECEMBER 7, 2000
REGISTRATION NO. 333-46426
===============================================================================
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
----------------------
PRE-EFFECTIVE AMENDMENT NO. 1
TO
FORM S-3
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
-------------------------------------
BOSTON BIOMEDICA, INC.
(Exact Name of Registrant as Specified in Its Charter)
MASSACHUSETTS 04-2652826
(STATE OR OTHER JURISDICTION OF (IRS EMPLOYER
INCORPORATION OR ORGANIZATION) IDENTIFICATION NUMBER)
375 WEST STREET
WEST BRIDGEWATER, MASSACHUSETTS 02379
(508) 580-1900
(Address, Including Zip Code, and Telephone Number, Including Area Code,
of Registrant's Principal Executive Offices)
-----------------------------------
RICHARD T. SCHUMACHER
BOSTON BIOMEDICA, INC.
375 WEST STREET
WEST BRIDGEWATER, MA 02379
(508) 580-1900
(Name, Address, Including Zip Code, and Telephone Number, Including Area Code,
of Agent for Service)
----------------------------------
COPIES TO:
STEVEN R. LONDON, ESQUIRE
BROWN, RUDNICK, FREED & GESMER
ONE FINANCIAL CENTER
BOSTON, MASSACHUSETTS 02111
TEL: (617) 856-8200
FAX: (617) 856-8201
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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. / /
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 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. / /
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.
===============================================================================
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PROSPECTUS (SUBJECT TO COMPLETION)
THE INFORMATION IN THIS PROSPECTUS IS NOT COMPLETE AND MAY BE CHANGED. WE HAVE
FILED A REGISTRATION STATEMENT RELATING TO THE COMMON STOCK WITH THE UNITED
STATES SECURITIES AND EXCHANGE COMMISSION. WE MAY NOT SELL THE COMMON STOCK
UNTIL THE SEC DECLARES THAT THE REGISTRATION STATEMENT IS EFFECTIVE. THIS
PROSPECTUS IS NOT AN OFFER TO SELL THE COMMON STOCK AND IT IS NOT SOLICITING AN
OFFER TO BUY THE COMMON STOCK IN ANY STATE WHERE THE OFFER OR SALE IS NOT
PERMITTED.
BOSTON BIOMEDICA, INC.
Up to 2,070,080 Shares of Common Stock
The shareholders named on page 17 are offering for sale up to 2,070,080
shares of our common stock under this prospectus.
Our common stock is traded on the Nasdaq National Market under the symbol
"BBII." On December 4, 2000, the last reported sale price of our common stock
was $2.25 per share.
AN INVESTMENT IN THE COMMON STOCK OFFERED UNDER THIS PROSPECTUS INVOLVES A HIGH
DEGREE OF RISK. SEE "RISK FACTORS" BEGINNING ON PAGE 5.
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 _______, 2000
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TABLE OF CONTENTS
SUMMARY.......................................................................4
RISK FACTORS..................................................................5
WARNINGS REGARDING FORWARD-LOOKING STATEMENTS................................15
USE OF PROCEEDS..............................................................15
SELLING SHAREHOLDERS.........................................................17
PLAN OF DISTRIBUTION.........................................................18
INDEMNIFICATION FOR SECURITIES ACT LIABILITIES...............................20
LEGAL MATTERS................................................................21
EXPERTS......................................................................21
WHERE YOU CAN FIND MORE INFORMATION..........................................21
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SUMMARY
ABOUT BOSTON BIOMEDICA
Boston Biomedica provides products and services for the detection and
treatment of infectious diseases such as AIDS, Lyme Disease, and viral
Hepatitis. We currently operate four business units:
(1) BBI Diagnostics, a manufacturer and seller of quality control
and diagnostic products that increase the accuracy of
diagnostic tests that are performed IN VITRO, in a test tube
or other laboratory equipment;
(2) BBI Clinical Laboratories, a leading infectious disease
testing laboratory that specializes in testing blood for the
presence or absence of nucleic acids in pathogens, testing for
tick borne diseases and follow-up testing for blood banks
after an initial test shows questionable or positive results;
(3) BBI Biotech Research Laboratories, our research and
development arm, which provides research and development
support for our other business units and contract research
services and specimen storage services for other parties,
including various agencies of the National Institutes of
Health; and,
(4) BBI Source Scientific, a manufacturer and seller of laboratory
and medical instruments.
In addition, we are also conducting research in a technology that
repeatedly applies and releases pressure on pathogens present in blood or plasma
in an effort to destroy them, with the goal of introducing new solutions for
improving blood plasma safety, for improving specimen preparation in the testing
of blood for the presence or absence of nucleic acids in pathogens and for
improving the treatment of infectious diseases.
We were organized in Massachusetts in 1978 and commenced significant
operations in 1986. Our principal executive offices are located at 375 West
Street, West Bridgewater, Massachusetts 02379. Our telephone number is (508)
580-1900.
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RISK FACTORS
BEFORE YOU BUY SHARES OF OUR COMMON STOCK, YOU SHOULD BE AWARE THAT THERE ARE
VARIOUS RISKS ASSOCIATED WITH THAT PURCHASE, INCLUDING THOSE DESCRIBED BELOW.
YOU SHOULD CONSIDER CAREFULLY THESE RISK FACTORS, TOGETHER WITH ALL OF THE OTHER
INFORMATION IN THIS PROSPECTUS AND THE DOCUMENTS WE HAVE INCORPORATED BY
REFERENCE IN THE SECTION "WHERE YOU CAN FIND MORE INFORMATION" BEFORE YOU DECIDE
TO PURCHASE SHARES OF OUR COMMON STOCK.
WE RELY ON PURCHASE ORDERS AND CONTRACTS FROM A SMALL NUMBER OF CUSTOMERS FOR A
LARGE PORTION OF OUR REVENUES; THE LOSS OF BUSINESS FROM THESE CUSTOMERS COULD
MATERIALLY REDUCE OUR REVENUES AND INCOME.
Purchase orders account for the majority of our orders; none of our
customers have contractually committed to make future product purchases from us.
In 1999, our three largest customers, Hoffman-La Roche, Inc., Medilabs, Inc. and
Ortho-Diagnostics, Inc. together accounted for approximately 16% of our
revenues. In addition, the various agencies of the National Institutes of
Health, including the National Institutes of Allergies and Infectious Disease,
the National Cancer Institute and the National Heart Lung and Blood Institute,
in the aggregate accounted for approximately 15% of our revenues in 1999. Each
agency within the National Institutes of Health, however, makes independent
purchasing decisions. The loss of any major customer, including any agency
within the National Institutes of Health, or a material reduction in any major
customer's purchases would materially reduce our revenues and our operating
results.
IF WE ARE UNABLE TO INCREASE OUR SALES OF QUALITY CONTROL PRODUCTS TO END-USERS
OF INFECTIOUS DISEASE TEST KITS, THEN OUR FUTURE REVENUES COULD BE LESS THAN WE
HAVE PROJECTED.
Currently, we sell most of our quality control products for infectious
disease test kits to test kit manufacturers and regulators, which is a
relatively small market. However, we also sell our quality control products to
end-users of infectious disease test kits, including hospital laboratories,
blood donor testing centers, public health laboratories and commercial
laboratories. This end-user market is a larger market which has not yet become
accustomed to using quality control products to monitor test results, but which
we believe is a growing market. Currently, we expect an increase in both the
frequency of use and the number of products used by our current end-user
customers. However, these end-users of infectious
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disease test kits may not increase their use of our products. Further, large
manufacturers and distributors of quality control products that have
historically sold to the non-infectious disease market and that have greater
financial, manufacturing and marketing resources than we have could begin
selling their products to the end-users of infectious disease test kits. If the
end-user market for quality control products for infectious disease testing does
not develop further, or if we are unable to increase sales of our products to
this market, our future revenues could be substantially less than we have
projected.
IF OUR BBI BIOSEQ, INC. AND BBI SOURCE SCIENTIFIC, INC. SUBSIDIARIES CONTINUE TO
HAVE SUBSTANTIAL OPERATING LOSSES, THEN WE MAY NOT BE ABLE TO REALIZE THE BOOK
VALUE OF THEIR ASSETS.
Our BBI BioSeq subsidiary has incurred operating losses of
approximately $2,160,000, since its acquisition in September 1998, through
September 30, 2000. This subsidiary may not be successful in developing its
in-process technology, and its technology may never achieve commercial
viability. If we cannot successfully commercially develop its technology, our
BBI BioSeq subsidiary may never become profitable and we may need to write off
some or all of the current net book value of its intangible assets related to
its patents, which was approximately $681,000 as of September 30, 2000.
As a result of our July 1997 acquisition of Source Scientific, Inc., we
recorded approximately $2,200,000 of goodwill. Since this acquisition, our BBI
Source Scientific subsidiary has incurred cumulative operating losses of
approximately $2,975,000, not including the write down of goodwill, as of
September 30, 2000. As of September 30, 2000, the net book value of goodwill
from the BBI Source Scientific acquisition of approximately $1,718,000 was
written down by approximately $1,464,000 to a balance of $254,000. That
subsidiary may continue to have operating losses and may never become
profitable. If operating losses continue, some or all of the remaining goodwill
associated with BBI Source Scientific may be written down or written off
entirely.
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IF WE ARE UNABLE TO OBTAIN BOTH THE NECESSARY REGULATORY APPROVALS AND
SUBSTANTIAL FUNDS FOR OUR BBI BIOSEQ SUBSIDIARY'S PRODUCTS, OUR FUTURE REVENUES
AND INCOME WILL BE LESS THAN WE HAVE PROJECTED.
Our BBI BioSeq subsidiary is currently developing products that will
require significant additional development, preclinical and clinical testing
regulatory approvals and investment of substantial funds prior to their
commercialization. Our BBI BioSeq subsidiary is developing laboratory
instruments that will use pressure cycling technology, a technology that
repeatedly applies and releases pressure on pathogens present in blood or plasma
in an effort to destroy them. Our BBI BioSeq subsidiary is also developing its
pressure cycling process to refine an existing laboratory instrument prototype.
Both the development of the laboratory instruments and the pressure cycling
process will require substantial capital and development activities to ready the
existing prototype for commercial use. The process of obtaining required
regulatory approvals can be costly and time-consuming, and we may not be able to
successfully develop our future products, prove them to be
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safe and effective in clinical trials or receive applicable regulatory
approvals. If we are not able to obtain substantial funds, develop adequate
technology and receive regulatory approvals for products being developed by our
BBI BioSeq subsidiary, our future revenues and income will be less than we have
projected.
IF THE FDA REQUIRES CLEARANCE OR APPROVAL FOR EITHER OUR PRODUCTS THAT ARE
DESIGNATED ONLY FOR RESEARCH AND NOT FOR DIAGNOSTIC PROCEDURES OR OUR PRODUCTS
THAT WE BELIEVE ARE EXEMPT FROM FDA CLEARANCE AND INITIATES ENFORCEMENT ACTION
FOR OUR FAILURE TO DO SO, WE WILL LIKELY EXPEND SIGNIFICANT RESOURCES TO RESOLVE
THE MATTER.
In the United States, the Food, Drug, and Cosmetic Act prohibits the
marketing of most IN VITRO diagnostic products until the Food and Drug
Administration either clears or approves the products through processes that are
time-consuming, expensive and uncertain. Some IN VITRO diagnostic products may
be exempt from FDA clearance or approval if they have undergone validation
studies. As of July 31, 2000, 31 of our Accurun 1-Registered Trademark- and
Accurun-Registered Trademark- products had received FDA clearance, and we
believe that 17 are exempt from FDA clearance . During 1999, our
Accurun-Registered Trademark- products accounted for approximately 11.55% of our
revenue. Although it has not done so in the past, the FDA may not agree that
some of these products are entitled to an exemption and may adopt a different
interpretation of the Food, Drug, and Cosmetic Act or other laws it administers.
We believe that products which are used only for research and not in diagnostic
procedures are not subject to FDA clearance or approval. We currently label some
of our products "for research use only" because they are not intended for use in
diagnostic procedures, and have not been cleared or approved by the FDA. It is
possible, however, that some purchasers of these products may use them for
diagnostic purposes rather than for research, despite our labeling. Under any of
these circumstances, the FDA could allege that some or all of these products
should have been cleared or approved, or otherwise validated prior to marketing,
and could initiate enforcement action against us. If the FDA initiates
enforcement action against us, we will likely expend a large amount of time,
money, resources and management attention to resolve the matter. In addition, if
we cannot obtain or are delayed in obtaining FDA clearances or approvals for our
products, we may encounter delays or be unable to ever sell those products.
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IF WE FAIL TO COMPLY WITH GOOD MANUFACTURING PRACTICES IN CONNECTION WITH THE
MANUFACTURE OF OUR MEDICAL DEVICE PRODUCTS, WE MAY NOT BE ABLE TO DISTRIBUTE OUR
PRODUCTS AND MAY NOT GENERATE PRODUCT REVENUES.
We are also subject to strict FDA good manufacturing practice
regulations which govern testing, control and documentation practices, and other
post-marketing restrictions on the manufacture of our medical device products.
Our IN VITRO diagnostic products and our laboratory instrumentation products are
considered "medical device products," as defined by the FDA. Regulatory
authorities monitor our ongoing compliance with good manufacturing practices and
other applicable regulatory requirements through periodic inspections. If we
fail to comply with good manufacturing practices or other regulatory
requirements, we may not be able to obtain future pre-market clearances or
approvals, or the FDA or other regulatory agencies may impose corrective action
requirements, including total or partial suspension of product distribution,
injunctions, civil penalties, recall or seizure of products, and criminal
prosecution. Any of these events would lead to increased costs and a drain on
resources and could reduce our revenues and operating results.
BECAUSE WE CONDUCT OUR BUSINESS WORLDWIDE, CHANGES IN INTERNATIONAL REGULATORY
REQUIREMENTS MAY MATERIALLY REDUCE OUR TOTAL REVENUES.
Our international sales accounted for approximately 13.7% of our total
revenues for the year ended December 31, 1999. Several Accurun-Registered
Trademark- products are subject to international regulatory approvals in Germany
and France. These approval processes are similar to the FDA clearance process.
Changes in international regulatory requirements and policies, including both
changes in existing restrictions and future restrictions on importation of blood
and blood derivatives, could result in reduced international sales, which may
materially reduce our total revenues and income.
IF WE ARE UNABLE TO OBTAIN A STEADY AND ADEQUATE SUPPLY OF RARE SPECIMENS OF
PLASMA AND SERUM, THEN WE MAY BE UNABLE TO PRODUCE OUR QUALITY CONTROL PANEL
PRODUCTS AND OUR ACCURUN-REGISTERED TRADEMARK- RUN CONTROLS PRODUCTS.
We manufacture our diagnostic products, including our quality control
panel products and Accurun-Registered Trademark- run controls products, from
human plasma and serum which we obtain from nonprofit and commercial blood
centers in the United States and from similar sources throughout the world. Our
BBI
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Diagnostics business unit, which manufactures and sells these diagnostic
products, accounts for approximately 40% of our revenues. Our quality control
panel products and Accurun(R) run control products contain unique and rare
plasma specimens that we collect from individuals who have been infected with
particular diseases. The specimens are unique and rare because we can collect
them only during the brief period of time when the markers for a particular
disease in an infected individual are converting from negative to positive. It
is difficult to identify such infected individuals and to collect specimens from
them during the brief period of time when the markers for a particular disease
are converting from negative to positive. As a result, quantities of these
specimens are limited. As we sell our quality control panel products and run
control products, we must find replacement specimens that are equally unique and
rare. We may also face competition to obtain these specimens which could further
limit our ability to obtain the specimens and to produce certain of our quality
control panel products and run control products. A limit in our ability to
produce our products would reduce our future revenues and operating results.
IF WE ARE NOT ABLE TO REACT QUICKLY TO TECHNOLOGICAL CHANGE, WE MAY NOT BE ABLE
TO COMPETE EFFECTIVELY.
The infectious disease test kit industry is characterized by rapid and
significant technological change, and changes in customer requirements. As a
result, our ability to continue to compete effectively in this industry depends
upon our ability to enhance our existing products and to develop or acquire, and
introduce in a timely manner, new products that take advantage of technological
advances and respond to customer requirements. We may not be successful in
developing and marketing such new products or enhancements to our existing
products on a timely basis, if at all, and such products may not adequately
address the changing needs of the marketplace. Furthermore, rapid technological
development may result in our products or services becoming obsolete or
noncompetitive before we recover our investment in research, development and
commercialization.
IF WE CANNOT PROTECT OUR INTELLECTUAL PROPERTY, WE MAY BE UNABLE TO COMPETE
EFFECTIVELY.
Our ability to compete effectively with other companies depends in part
on our ability to maintain the proprietary nature of our technologies and
products. We rely primarily on a combination of trade secrets and non-disclosure
and confidentiality agreements to establish and protect our proprietary rights
in our technology and products.
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We have 15 patents pending related to the pressure cycling technology that our
BBI BioSeq subsidiary is developing. If we have not adequately protected our
technology, or if our competitors misappropriate our intellectual property, we
could lose market share and our future revenues and operating income could be
significantly less than projected.
IF WE ARE UNABLE TO ATTRACT AND RETAIN HIGHLY QUALIFIED SCIENTIFIC AND
MANAGEMENT PERSONNEL, THEN WE MAY NOT BE ABLE TO DEVELOP AND REFINE OUR PRODUCTS
AND SERVICES.
Our products and services are highly technical and our key personnel
must have specialized training or advanced degrees in order to develop and
refine these products and services. There are a limited number of qualified
scientific and management personnel who possess the technical background
necessary to adequately understand and improve our products and services. We
compete for these personnel with other companies, academic institutions,
government entities and other organizations engaged in research and development
of quality control products. If we are unable to attract and retain scientific
and management personnel with the appropriate credentials who are capable of
developing and refining our products and services, then our products and
services could become inaccurate or unreliable, or could fail to obtain FDA
approval and we may be unable to deliver new products.
PENDING LITIGATION COULD RESULT IN SUBSTANTIAL COSTS AND MAY DIVERT MANAGEMENT'S
ATTENTION AND RESOURCES.
On August 18, 2000, we received a summons and complaint from Paradigm
Group, LLC, naming us as a defendant. The suit, filed in the Circuit Court of
Cook County, Illinois, alleges breach of contract claims and fraud against us in
connection with the sale by us to them of warrants to purchase our shares of
common stock, the exercise of those warrants by Paradigm Group, LLC, and a delay
in the registration of those shares. Paradigm Group, LLC, seeks several
remedies, including $3 million in damages or unspecified monetary damages,
return of the $42,500 purchase price for the warrants and rescission of its
exercise of the warrants, and unspecified punitive damages. We have announced
that we intend to vigorously defend this matter. This lawsuit could result in
substantial costs and may divert management's attention and resources. Any
adverse determination in this case could also subject us to significant
liabilities.
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INSIDERS CONTROL A SIGNIFICANT PERCENTAGE OF VOTING POWER AND MAY EXERCISE THEIR
VOTING POWER IN A MANNER ADVERSE TO OTHER SHAREHOLDERS' INTERESTS.
Our chief executive officer, Richard T. Schumacher, his relatives, and
our other existing officers and directors collectively have voting control over
approximately 35% of the outstanding shares of our common stock. Accordingly,
these shareholders, should they choose to act in concert, are in a position to
exercise a significant degree of control and to significantly influence
shareholder votes on the election of directors, increasing the authorized
capital stock, and authorizing mergers and sales of assets. These shareholders
may act in a manner that is adverse to your personal interests.
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PROVISIONS IN OUR CHARTER AND BY-LAWS MAY DISCOURAGE OR FRUSTRATE SHAREHOLDERS'
ATTEMPTS TO REMOVE OR REPLACE OUR CURRENT MANAGEMENT.
Our amended and restated articles of organization and restated bylaws
contain provisions that may make more difficult or discourage changes in our
management that our shareholders may consider to be favorable. These provisions
include:
- a classified board of directors;
- advance notice to the board of directors of shareholder proposals and
shareholder nominees for the board of directors;
- limitations on the ability of shareholders to remove directors and call
shareholders meetings; and
- a provision that allows a majority of the directors to fill vacancies
on the board of directors.
These provisions could prevent or frustrate shareholders' attempts to
make changes in our management that our shareholders consider to be beneficial.
THE CONVERSION OF OUR OUTSTANDING 3% SENIOR SUBORDINATED CONVERTIBLE DEBENTURES
AND/OR THE EXERCISE OF OUTSTANDING WARRANTS TO PURCHASE OUR COMMON STOCK WILL
HAVE A DILUTIVE IMPACT ON OUR SECURITY HOLDERS AND MAY PLACE DOWNWARD PRESSURE
ON THE PRICE OF OUR COMMON STOCK.
The number of shares of common stock that may ultimately be issued upon
conversion of the outstanding debentures is presently undeterminable because the
conversion price of the debentures is the lower of: (i) $3.36 a share or (ii)
90% of the average of the five (5) lowest volume weighted average sales prices
of our common stock as reported by Bloomberg, L.P. during the 25 business days
immediately preceding the date on which any debenture holder notifies us that it
will convert all or a part of their debenture into common stock. Assuming a
conversion price of $3.36 a share, conversion of all our outstanding debentures
would result in the issuance of 967,262 shares of common stock. This represents
about 17.2% of our outstanding common stock based on the number of shares
outstanding as of September 19, 2000. In addition, the number of shares issuable
upon conversion of the debentures will increase if the price of our common stock
drops below $3.36 a share. For example, if the average of the five (5) lowest
volume weighted average sales prices of our common stock as reported by
Bloomberg,
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L.P. during the 25 business days immediately preceding the date on which any
debenture holder elects to convert all or a part of their debenture into common
stock is equal to $2.00 a share, and assuming all the debentures were converted,
we would issue approximately 1,625,000 shares of our common stock, which
represents approximately 28.8% of our issued and outstanding common stock based
on the number of shares outstanding as of September 19, 2000. A downward spiral
in the price of our common stock could result in the loss of a significant
portion of your investment, and the conversion of our outstanding debentures
could place downward pressure on the price of our common stock. The terms of the
debenture entitle us to redeem any of the outstanding debenture(s) at a
redemption price equal to (x) the number of shares of common stock into which
said debenture(s) is then convertible times (y) the average closing bid price as
reported by Bloomberg L.P. for the five (5) trading days immediately prior to
the date that the debenture(s) is called for redemption, plus accrued and unpaid
interest. We may not have sufficient funds to redeem the debentures at such time
as we determine it is most appropriate to redeem the debenture(s).
In addition, we have outstanding warrants, with various strike prices,
which are exercisable for a total of 494,709 shares of our common stock
(warrants for 135,556 of which were issued to the selling shareholders named on
page 17). This represents approximately 8.8% of our issued and outstanding
common stock based on the number of shares issued and outstanding as of
September 19, 2000. The exercise of our outstanding warrants could place
downward pressure on the price of our common stock.
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WARNINGS REGARDING FORWARD-LOOKING STATEMENTS
Some of the statements contained in this prospectus under "Summary" and
"Risk Factors," and in the documents incorporated by reference, are
forward-looking statements made pursuant to the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995. In essence, forward-looking
statements are predictions of future events. Although we would not make
forward-looking statements unless we believe we have a reasonable basis for
doing so, we cannot guarantee their accuracy, and actual results may differ
materially from those we anticipated due to a number of uncertainties, many of
which we are not aware. We urge you to consider the risks and uncertainties
discussed under "Risk Factors" and in the other documents filed with the SEC
that we have referred you to in evaluating our forward-looking statements.
You should also understand that we have no plans to update our
forward-looking statements. Our forward-looking statements speak only as of the
date of this prospectus, or in the case of forward-looking statements in
documents incorporated by reference, as of the date of those documents.
We generally identify forward-looking statements with the words "plan,"
"expect," "anticipate," "believe," "intend," "estimate," "continue," "will,"
"may," "should" and similar expressions. Examples of our forward-looking
statements may include statements related to:
- our plans, objectives, expectations and intentions;
- the timing, availability, cost of development and
functionality of products under development or recently
introduced; and
- the anticipated markets for our products and the success of
our products in those markets.
USE OF PROCEEDS
The selling shareholders are selling all of the shares covered by this
prospectus for their own account. Accordingly, we will not receive any proceeds
from the resale of the shares.
The 2,070,080 shares of our common stock that we are registering under
this prospectus include shares that may be issued to selling shareholders upon
the conversion of our outstanding stock purchase warrants and shares that may be
issued upon the conversion our outstanding debentures and upon the exercise of
our outstanding stock purchase warrants.
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The common stock offered by this prospectus is the common stock
issuable upon conversion of our outstanding debentures and upon exercise of the
warrants issued in an August 25, 2000 private placement. GCA Strategic
Investment Fund Limited purchased its 3% senior subordinated convertible
$2,250,000 debenture and 80,000 warrants to purchase our common stock pursuant
to a Securities Purchase Agreement with us, dated as of August 25, 2000. The
total purchase price for the debenture was $2,137,500. No additional
consideration was paid to us for the warrant issued to GCA. DP Securities, Inc.
and Wharton Capital Partners, Ltd. received stock purchase warrants as a fee for
services rendered in connection with the private placement to GCA. Each of DP
Securities and Wharton Capital may exercise warrants to purchase 10,000 shares
of our common stock at an exercise price of $3.60 per share. Richard T. Kiphart
purchased a $780,000 3% senior subordinated convertible debenture and warrants
to purchase 27,734 shares of common stock. Shoreline Micro-Cap Fund, L.P
purchased a $220,000 senior subordinated convertible debenture and warrants to
purchase 7,822 shares of common stock. Each of Mr. Kiphart and Shoreline
obtained their debentures and warrants pursuant to a Securities Purchase
Agreement with us dated as of August 25, 2000. Mr. Kiphart paid $741,000 to
obtain his debenture, and Shoreline paid $209,000 to obtain its debenture. Mr.
Kiphart and Shoreline did not pay any additional consideration for their
warrants.
We will use the proceeds which we have received from the sale of the
debentures for completion of our West Bridgewater, MA manufacturing facility, to
fund pressure cycling technology research and development and for general
corporate and working capital purposes. Any proceeds we receive from the
exercise of the warrants will be used for r working capital purposes.
We prepared this prospectus to satisfy our obligations to the selling
shareholders to register their shares pursuant to a Registration Rights
Agreement which we entered into with GCA, DP Securities and Wharton Capital on
August 25, 2000, and a Registration Rights Agreement which we entered into with
Mr. Kiphart and Shoreline on August 25, 2000. We will bear the expenses relating
to this registration, other than selling discounts and commissions, which will
be paid by the selling shareholders.
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SELLING SHAREHOLDERS
The selling shareholders named below are offering for sale up to
2,070,080 shares of our common stock under this prospectus. We will not receive
any proceeds from those sales. The 2,070,080 shares of our common stock that we
are registering under this prospectus includes shares that may be issued to the
selling shareholders upon the conversion of our outstanding debentures and the
exercise of our outstanding stock purchase warrants.
The following table sets forth information regarding the beneficial
ownership of our common stock by the selling shareholders as of November 15,
2000 and is adjusted to reflect the sale or transfer by the selling shareholders
of the shares of our common stock being registered under this prospectus,
including the sale or transfer of shares of our common stock underlying the
debentures and the warrants held by selling shareholders. This information is
based upon information received from or on behalf of the selling shareholders.
The number of shares beneficially owned by Richard T. Kiphart, Shoreline
Micro-Cap Fund, L.P. and GCA Strategic Investment Fund Limited is estimated
assuming a conversion price of $3.36 for the debentures held by these selling
shareholders. The conversion price of the debentures held by these selling
shareholders will be the lesser of (i) $3.36 a share or (ii) 90% of the average
of the five (5) lowest volume weighted average sales prices of our common stock
as reported by Bloomberg, L.P. during the 25 business days immediately preceding
the date on which a selling shareholder holding a debenture notifies us that it
will convert all or part of its debenture into common stock. We have chosen to
register approximately 200% of the number of shares we estimate to be currently
issuable upon conversion of the debentures so that a sufficient number of shares
is registered in the event that the conversion price of the debentures declines
below $3.36 a share.
17
<PAGE>
<TABLE>
<CAPTION>
SHARES TOTAL SHARES
BENEFICIALLY NUMBER OF BENEFICIALLY
OWNED SHARES BEING OWNED AFTER
PRIOR TO OFFERING OFFERED OFFERING
NAME OF SECURITYHOLDER NUMBER PERCENT NUMBER NUMBER PERCENT
<S> <C> <C> <C> <C> <C>
GCA Strategic Investment Fund Limited.(1) 749,643 11.73% 749,643 0 *
DP Securities, Inc. (2) 10,000 * 10,000 0 *
Wharton Capital Partners, Ltd. (2) 10,000 * 10,000 0 *
Richard P. Kiphart (3) 259,877 4.4%* 259,877 0 *
Shoreline Micro-Cap Fund, L.P. (4) 73,298 1.28% 73,298 0 *
</TABLE>
----------------
* Less than 1%.
(1) Consists of an estimated 669,643 shares of our common stock issuable upon
the conversion of our debenture and 80,000 shares of common stock issuable
pursuant to the exercise of warrants. The number of shares issuable upon
conversion of the debenture was calculated based on a conversion price of $3.36.
(2) Consists of warrants to purchase an aggregate of 10,000 shares of our common
stock.
(3) Consists of an estimated 232,143 shares of our common stock issuable upon
the conversion of our debenture and 27,734 shares of our common stock issuable
pursuant to the exercise of warrants. The number of shares issuable upon
conversion of the debenture was calculated based on a conversion price of $3.36.
(4) Consists of an estimated 65,476 shares of our common stock issuable upon the
conversion of our debenture and 7,822 shares of our common stock issuable
pursuant to the exercise of warrants. The number of shares issuable upon
conversion of the debenture was calculated based on a conversion price of $3.36.
PLAN OF DISTRIBUTION
The selling shareholders and their pledgees, donees, transferees and
other non-sale transferees may offer their shares at various times in one or
more of the following transactions:
- in the Nasdaq National Market;
- in the over-the-counter market; or
- in privately negotiated transactions
at prevailing market prices at the time of sale, at prices related to those
prevailing market prices, at negotiated prices or at fixed prices.
18
<PAGE>
The selling shareholders may also sell the shares under Rule 144
instead of under this prospectus, if Rule 144 is available for those sales.
We will not receive any proceeds from the sale of our common stock by
the selling shareholders.
The transactions in the shares covered by this prospectus may be
carried out by one or more of the following methods:
- ordinary brokerage transactions and transactions in which the
broker solicits purchasers;
- purchases by a broker or dealer as principal, and the resale
by that broker or dealer for its account as part of the
distribution under this prospectus, including resale to
another broker or dealer;
- block trades in which the broker or dealer will attempt to
sell the shares as agent but may position and resell a portion
of the block as principal in order to facilitate the
transaction; or
- negotiated transactions between selling shareholders and
purchasers, with or without a broker or dealer.
As of the date of this prospectus, we are not aware of any agreement,
arrangement or understanding between any broker or dealer and any of the selling
shareholders with respect to the offer or sale of the shares under this
prospectus.
We have advised the selling shareholders that, during the time each is
engaged in distributing shares covered by this prospectus, each must comply with
the requirements of the Securities Act and the Exchange Act, including Rule
10b-5 and Regulation M. Under those rules and regulations, they:
- may not engage in any stabilization activity in connection
with our securities;
- must furnish each broker that offers common stock covered by
this prospectus with the number of copies of this prospectus
that are required by each broker; and
- may not bid for or purchase any of our securities or attempt
to induce any person to purchase any of our securities other
than as permitted under the Exchange Act.
19
<PAGE>
We have agreed to indemnify and hold harmless each selling shareholder
against liabilities under the Securities Act, which may be based upon, among
other things, any untrue statement or alleged untrue statement of a material
fact or any omission or alleged omission of a material fact, unless made or
omitted in reliance upon written information provided to us by that selling
shareholder for use in this prospectus. We have agreed to bear the expenses
incident to the registration of the shares, other than selling discounts and
commissions.
INDEMNIFICATION FOR SECURITIES ACT LIABILITIES
Our Amended and Restated Articles of Organization eliminate, subject to
certain exceptions, the personal liability of our directors for monetary damages
for breaches of fiduciary duties as directors. Our Amended and Restated Articles
do not provide for the elimination of, or any limitation on, the personal
liability of a director for (i) any breach of the director's duty of loyalty to
Boston Biomedica and our shareholders; (ii) acts or omissions not in good faith
or which involve intentional misconduct or a knowing violation of law; (iii)
certain unauthorized dividends, redemptions or distributions as provided under
Section 61 of the Massachusetts Business Corporation Law; (iv) certain loans of
company assets to any of our officers or directors as provided under Section 62
of the Massachusetts Business Corporation Law; or (v) any transaction from which
the director derived an improper personal benefit. This provision of our Amended
and Restated Articles of Organization will limit the remedies available to you
in the event of breaches of any director's duties to Boston Biomedica and our
shareholders. Our Amended and Restated Articles of Organization provide that we
may, either in our by-laws or by contract, provide for the indemnification of
directors, officers, employees and agents, by whomever elected or appointed, to
the full extent permitted by law.
Insofar as indemnification for liabilities arising under the Securities
Act of 1933 may be permitted to our directors, officers or controlling persons
pursuant to the foregoing provisions, or otherwise, we have been informed that
in the opinion of the Securities and Exchange Commission such indemnification is
against public policy as expressed in the Securities Act and is, therefore,
unenforceable.
20
<PAGE>
LEGAL MATTERS
For the purpose of this offering, Brown, Rudnick, Freed & Gesmer,
Boston, Massachusetts, will pass upon the validity of the shares of common stock
covered under this prospectus.
EXPERTS
The financial statements incorporated in this prospectus by reference
to the Annual Report on Form 10-K for the year ended December 31, 1999 have been
so incorporated in reliance on the report of PricewaterhouseCoopers LLP,
independent accountants, given on the authority of said firm as experts in
auditing and accounting. The valuation information incorporated in this
prospectus by reference to the Annual Report on Form 10-K for the year ended
December 31, 1999 has been so incorporated in reliance on the valuation report
of The Michel/Shaked Group, a division of Back Bay Management Corporation, given
on the authority of said firm as experts in asset valuation.
WHERE YOU CAN FIND MORE INFORMATION
We file annual, quarterly and special reports, proxy statements and
other information with the SEC. You may read and copy any document we file at
the SEC's public reference rooms at 450 Fifth Street, N.W., Washington, D.C.,
20549, in Chicago, Illinois and in New York, New York. Please call the SEC at
1-800-SEC-0330 for further information on the public reference rooms. Our SEC
filings are also available to the public over the Internet on the SEC's website
at http://www.sec.gov.
We have filed with the SEC a registration statement on Form S-3 under
the Securities Act of 1933, as amended, with respect to the common stock offered
in connection with this prospectus. This prospectus does not contain all of the
information set forth in the registration statement. We have omitted parts of
the registration statement in accordance with the rules and regulations of the
SEC. For further information with respect to us and our common stock, you should
refer to the registration statement and to the exhibits and schedules filed as
part of the registration statement, as well as the documents discussed below.
Statements contained in this prospectus as to the contents of any contract or
other document are not necessarily complete and, in each instance, you should
refer to the copy of the contract or document filed as an exhibit to or
incorporated by reference in the registration statement. Each statement as to
the
21
<PAGE>
contents of any contract or document is qualified in all respects by reference
to the contract or document itself. You may obtain copies of the registration
statement from the SEC's principal office in Washington, D.C. upon payment of
the fees prescribed by the SEC, or you may examine the registration statement
without charge at the offices of the SEC described above.
The SEC allows us to "incorporate by reference" the information that we
file with it, which means that we can disclose important information to you by
referring you to those documents. The information incorporated by reference is
considered to be part of this prospectus, and information that we file later
with the SEC will automatically update and supersede this information. We
incorporate by reference the following documents:
- Our Annual Report on Form 10-K for the fiscal year ended
December 31, 1999, as amended;
- Our Quarterly Report on Form 10-Q for the fiscal quarter ended
March 31, 2000, as amended;
- Our Quarterly Report on Form 10-Q for the fiscal quarter ended
June 30, 2000, as amended;
- Our Quarterly Report on Form 10-Q for the fiscal quarter ended
September 30, 2000, as amended;
- Our Definitive Proxy Statement as Schedule 14A and proxy
materials filed on May 1, 2000;
- Our Current Report on Form 8-K filed on September 8, 2000; and
- The description of our common stock contained in our
registration statement on Form 8-A dated October 25, 1996.
We also incorporate by reference any future filings made with the SEC under
Sections 13(a), 13(c), 14 or 15(d) of the Securities Exchange Act of 1934, as
amended, prior to the termination of the offering to which this prospectus
relates.
You may request a copy of any or all of these filings, at no cost, by
writing or telephoning us at the following address:
Boston Biomedica, Inc.
375 West Street
West Bridgewater, MA 02379
(508) 580-1900
Attn: Investor Relations
22
<PAGE>
THIS PROSPECTUS IS PART OF A REGISTRATION STATEMENT WE FILED
WITH THE SEC. YOU SHOULD RELY ONLY ON THE INFORMATION OR
REPRESENTATIONS PROVIDED IN THIS PROSPECTUS. WE HAVE NOT
AUTHORIZED ANYONE TO PROVIDE YOU WITH ANY INFORMATION THAT
IS NOT CONTAINED IN THIS PROSPECTUS. THE SELLING SHAREHOLDERS
DESCRIBED IN THIS PROSPECTUS ARE NOT MAKING AN OFFER TO SELL
OR SOLICITING AN OFFER TO BUY ANY SHARES IN ANY JURISDICTION
WHERE THE OFFER OR SALE IS NOT PERMITTED. YOU SHOULD NOT
ASSUME THAT THE INFORMATION IN THIS PROSPECTUS IS ACCURATE AS
OF ANY DATE OTHER THAN THE DATE OF THIS PROSPECTUS.
-----------------
TABLE OF CONTENTS
-----------------
Summary 4
Risk Factors 5
Warnings Regarding Forward-Looking Statements 14
Use of Proceeds 15
Selling Shareholders 17
Plan of Distribution 20
Indemnification for Securities Act Liabilities 18
Legal Matters 21
Experts 21
Where You Can Find More Information 21
BOSTON BIOMEDICA, INC.
Up to 2,070,080 Shares of Common Stock
PROSPECTUS
(Subject to Completion)
<PAGE>
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
ITEM 14. OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION
The following table sets forth the various expenses payable by us in connection
with the sale and distribution of the securities registered hereby. All amounts
are estimated except the SEC and Nasdaq fees. We will bear all of the costs of
issuance and distribution as follows:
<TABLE>
<S> <C>
SEC Registration Fee................................................... $ 2,937.44
Nasdaq Filing Fee...................................................... $17,500.00
Accounting Fees and Expenses........................................... $10,000.00
Legal Fees and Expenses................................................ $20,000.00
Costs of Printing and Engraving........................................ $ 1,000.00
Miscellaneous.......................................................... $ 562.56
----------
Total......................................................... $52,000.00
==========
</TABLE>
ITEM 15. INDEMNIFICATION OF DIRECTORS AND OFFICERS
Our amended and restated by-laws include provisions to permit the
indemnification of our officers and directors for damages arising out of the
performance of their duties unless such damages arise out of the officer's or
director's failure to exercise his duties and to discharge the duties of his
office in good faith and in the reasonable belief that his action was in, or not
opposed to, the best interest of Boston Biomedica, and with respect to any
criminal action or proceeding, do not have reasonable cause to believe that his
conduct was unlawful.
ITEM 16. EXHIBITS
<TABLE>
<CAPTION>
EXHIBIT
NUMBER
<S> <C>
4.1 Description of certificate for shares of Boston Biomedica common stock *
4.2 Form of Debenture **
4.3 Form of Warrant ***
4.4 Form of Registration Rights Agreement ****
4.5 Form of Securities Purchase Agreement *****
5.1 Legal Opinion of Brown, Rudnick, Freed & Gesmer, P.C. previously filed
23.1 Consent of PricewaterhouseCoopers LLP filed hereunder
23.2 Consent of The Michel/Shaked Group, a division of Back Bay Management filed hereunder
Corporation
23.3 Consent of Brown, Rudnick, Freed & Gesmer, P.C. (included in Exhibit 5.1) previously filed
24.1 Power of Attorney (included in the signature page to this registration previously filed
statement)
</TABLE>
<PAGE>
----------
*The above exhibit was previously filed as an exhibit of the same number to our
Registration Statement on Form S-1 (registration no. 333-10759), as amended,
filed on August 23, 1996 and is incorporated herein by reference.
**The above exhibit was previously filed as exhibit numbers 4.1, 4.6 and 4.7 to
our Current Report on Form 8-K filed on September 8, 2000 and is incorporated
herein by reference.
***The above exhibit was previously filed as exhibit numbers 4.2, 4.3, 4.4, 4.8
and 4.9 to our Current Report on Form 8-K filed on September 8, 2000 and is
incorporated herein by reference.
****The above exhibit was previously filed as exhibit numbers 4.5 and 4.10 to
our Current Report on Form 8-K filed on September 8, 2000 and is incorporated
herein by reference.
*****The above exhibit was previously filed as exhibit numbers 10.1 and 10.2 to
our Current Report on Form 8-K filed on September 8, 2000 and is incorporated
herein by reference.
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 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;
(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; and
(3) To remove from registration by means of a post-effective amendment
any of the securities being registered which remain unsold at the
termination of the offering.
(b) The undersigned registrant hereby undertakes that, for purposes of
determining any liability under the Securities Act of 1933, each filing of the
registrant's annual report pursuant to Section 13(a) or Section 15(d) of the
Securities Exchange Act of 1934 (and, where applicable, each filing of an
employee benefit plan's annual report pursuant to Section 15(d) of the
Securities Exchange Act of 1934) that is incorporated by reference in the
registration statement shall be deemed to be a new registration statement
relating to the securities offered therein, and the offering of such securities
at that time shall be deemed to be the initial BONA FIDE offering thereof.
(c) Not applicable.
(d) Not applicable.
(e) Not applicable.
(f) Not applicable.
(g) Not applicable.
(h) 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 SEC such indemnification
is against public policy as expressed in the Securities Act of 1933 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 of whether such indemnification by it is against
public policy as expressed in the Securities Act of 1933 and will be governed by
the final adjudication of such issue.
(i) Not applicable.
(j) Not applicable.
<PAGE>
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 the
requirements for filing on Form S-3 and has duly caused this pre-effective
amendment number 1 to the registration statement to be signed on its behalf by
the undersigned, thereunto duly authorized, in the Town of West Bridgewater,
Commonwealth of Massachusetts, on December 7, 2000.
BOSTON BIOMEDICA, INC.
By: /s/ RICHARD T. SCHUMACHER
-------------------------
Richard T. Schumacher,
Chief Executive Officer
PURSUANT TO THE REQUIREMENTS OF THE SECURITIES ACT OF 1933, THIS
PRE-EFFECTIVE AMENDMENT NUMBER 1 TO THIS REGISTRATION STATEMENT HAS BEEN SIGNED
BY THE FOLLOWING PERSONS IN THE CAPACITIES AND ON THE DATES INDICATED.
<TABLE>
<CAPTION>
SIGNATURE TITLE DATE
<S> <C> <C>
/s/ RICHARD T. SCHUMACHER Director and Principal Executive Officer December 7, 2000
---------------------------------------
Richard T. Schumacher
/s/ KEVIN W. QUINLAN Director and Principal Financial and December 7, 2000
--------------------------------------- Accounting Officer
Kevin W. Quinlan
* Director December 7, 2000
---------------------------------------
Francis E. Capitanio
* Director December 7, 2000
---------------------------------------
Calvin A. Saravis, Ph.D.
* Director and Treasurer December 7, 2000
--------------------------------------
William R. Prather, R.Ph., M.D.
* By: /s/ RICHARD T. SCHUMACHER
-------------------------
Richard T. Schumacher,
Attorney-in-Fact
</TABLE>
<PAGE>
EXHIBIT INDEX
<TABLE>
<CAPTION>
EXHIBIT
NUMBER
<S> <C> <C>
4.1 Description of certificate for shares of Boston Biomedica common stock *
4.2 Form of Debenture **
4.3 Form of Warrant ***
4.4 Form of Registration Rights Agreement ****
4.5 Form of Securities Purchase Agreement *****
5.1 Legal Opinion of Brown, Rudnick, Freed & Gesmer, P.C. previously filed
23.1 Consent of PricewaterhouseCoopers LLP filed hereunder
23.2 Consent of The Michel/Shaked Group, a division of Back Bay Management filed hereunder
Corporation
23.3 Consent of Brown, Rudnick, Freed & Gesmer, P.C. (included in Exhibit 5.1) previously filed
24.1 Power of Attorney previously filed
</TABLE>
----------
*The above exhibit was previously filed as an exhibit of the same number to our
Registration Statement on Form S-1 (registration no. 333-10759), as amended,
filed on August 23, 1996 and is incorporated herein by reference.
**The above exhibit was previously filed as exhibit numbers 4.1, 4.6 and 4.7 to
our Current Report on Form 8-K filed on September 8, 2000 and is incorporated
herein by reference.
***The above exhibit was previously filed as exhibit numbers 4.2, 4.3, 4.4, 4.8
and 4.9 to our Current Report on Form 8-K filed on September 8, 2000 and is
incorporated herein by reference.
****The above exhibit was previously filed as exhibit numbers 4.5 and 4.10 to
our Current Report on Form 8-K filed on September 8, 2000 and is incorporated
herein by reference.
*****The above exhibit was previously filed as exhibit numbers 10.1 and 10.2 to
our Current Report on Form 8-K filed on September 8, 2000 and is incorporated
herein by reference.
