As filed with the Securities and Exchange Commission on January 22, 1998.
Registration No. 333-39421
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
____________________
FORM S-3/A
(AMENDMENT NO. 2)
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
____________________
BIOJECT MEDICAL TECHNOLOGIES INC.
(Exact Name of Registrant as Specified in Its Charter)
7620 SW Bridgeport Road
Portland, Oregon 97224
(503) 639-7221
(Address, including zip code, and telephone number, including area code, of
registrant's principal executive offices)
Oregon 3845 93-1099680
(State of other jurisdiction (Primary Standard Industrial (I.R.S. Employer
incorporation or organization Classification Code Number) Identification
Number)
James C. O'Shea
Chief Executive Officer
Bioject Medical Technologies Inc.
7620 SW Bridgeport Road
Portland, Oregon 97224
(503) 639-7221
(Name, address, including zip code, and telephone number, including area code,
of agent for service)
____________________
Copies to:
Christopher J. Barry, Esq.
BOGLE & GATES P.L.L.C.
Two Union Square, 601 Union Street
Seattle, Washington 98101
206-682-5151
____________________
Approximate date of commencement of proposed sale to the public: At such time
or from time to time after the effective date of this Registration Statement as
the respective Selling Shareholders shall determine.
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, please 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 the 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, as amended, or until this Registration Statement shall
become effective on such date as the Commission, acting pursuant to said
Section 8(a), may determine.
INFORMATION CONTAINED HEREIN IS SUBJECT TO COMPLETION OR AMENDMENT. A
REGISTRATION STATEMENT RELATING TO THESE SECURITIES HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION. THESE SECURITIES MAY NOT BE SOLD NOR
MAY OFFERS TO BUY BE ACCEPTED PRIOR TO THE TIME THE REGISTRATION STATEMENT
BECOMES EFFECTIVE. THIS PROSPECTUS SHALL NOT CONSTITUTE AN OFFER TO SELL
OR THE SOLICITATION OF AN OFFER TO BUY NOR SHALL THERE BE ANY SALE OF THESE
SECURITIES IN ANY STATE IN WHICH SUCH OFFER, SOLICITATION OR SALE WOULD BE
UNLAWFUL PRIOR TO REGISTRATION OR QUALIFICATION UNDER THE SECURITIES LAWS OF
ANY SUCH STATE.
SUBJECT TO COMPLETION, DATED JANUARY 22, 1998
PROSPECTUS
3,214,663 SHARES
BIOJECT MEDICAL TECHNOLOGIES INC.
COMMON STOCK
_____________________
This Prospectus pertains to the offer and sale from time to time of up to
3,214,663 shares (the "Shares") of common stock, without par value (the "Common
Stock"), of Bioject Medical Technologies Inc. ("Bioject" or the "Company") by
or for the account of certain of the Company's shareholders (collectively, the
"Selling Shareholders"). See "Selling Shareholders."
The Shares offered hereby may be sold by the Selling Shareholders directly or
through agents, underwriters or dealers as designated from time to time or
through a combination of such methods. The Company will receive none of the
proceeds from any sale of Shares by or for the account of the Selling
Shareholders. The Selling Shareholders and any broker-dealers that participate
with one or more of the Selling Shareholders in the distribution of the Shares
may be deemed to be underwriters and any commissions received or profit
realized by them in connection with the resale of the Shares might be deemed
to be underwriting discounts and commissions under the Securities Act of
1933, as amended (the "Securities Act"). See "Selling Shareholders" and
"Plan of Distribution."
The Company has agreed to bear all expenses relating to this registration,
other than underwriting discounts and commissions. In addition, the Company
has agreed to indemnify the Selling Shareholders against certain liabilities,
including liabilities under the Securities Act. See "Selling Shareholders" and
"Plan of Distribution."
The Common Stock is quoted on the NASDAQ National Market under the symbol
"BJCT". On January 21, 1998, the closing bid price of the Common Stock as
reported by NASDAQ was $1.093.
_____________________
See "Risk Factors" beginning on page four of this Prospectus for a discussion
of certain factors that should be considered by prospective purchasers of the
Common Stock.
_____________________
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.
The Shares may be offered from time to time in negotiated transactions or
otherwise at market prices prevailing at the time of each sale, subject to the
right of the Selling Shareholders to reject any order in whole or in part.
The date of this Prospectus is January __, 1998.
AVAILABLE INFORMATION
The Company has filed with the Securities and Exchange Commission (the
"Commission"), 450 Fifth Street N.W., Washington, D.C. 20549, a Registration
Statement on Form S-3 (the "Registration Statement") under the Securities Act,
and the rules and regulations promulgated thereunder, with respect to the
Shares offered pursuant to this Prospectus. This Prospectus, which is part of
the Registration Statement, does not contain all of the information set forth
in the Registration Statement and the exhibits thereto. Certain financial
and other information relating to the Company is contained in the documents
indicated below under "Incorporation of Certain Documents By Reference" which
are not presented herein or delivered herewith. For further information with
respect to the Company and the Shares, reference is made to the Registration
Statement and such exhibits, copies of which may be examined without charge
at, or obtained upon payment of prescribed fees from, the Public Reference
Section of the Commission at Room 1024, Judiciary Plaza, 450 Fifth Street,
N.W., Washington, D.C. 20549, or by way of the Commission's Internet address,
http://www.sec.gov, and will also be available for inspection and copying
at the regional offices of the Commission located at 7 World Trade Center,
Suite 1300, New York, New York 10048 and at Citicorp Center, 500 W. Madison
Street, Suite 1400, Chicago, Illinois 60661-2511.
Statements contained in this Prospectus as to the contents of any contract or
other document which is filed as an exhibit to the Registration Statement are
not necessarily complete, and each such statement is qualified in its entirety
by reference to the full text of such contract or document.
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, proxy statements and other information with the
Commission. Such reports, proxy statements and other information can be
inspected and copied at the locations described above. Copies of such
materials can be obtained by mail from the Public Reference Section of the
Commission at 450 Fifth Street, N.W., Washington, DC 20549, at prescribed
rates. In addition, the Common Stock is listed on the NASDAQ National Market.
Material filed by the Company can be inspected at the offices of the National
Association of Securities Dealers, Inc., 1735 K Street, N.W., Washington, D.C.
20006.
INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE
The following documents, which have been filed by the Company with the
Commission, are incorporated herein by reference:
1. The Company's Annual Report on Form 10-K for the year ended March 31, 1997.
2. Amendments to the Company's Annual Report for the year ended March 31, 1997,
on Forms 10-K/A filed on July 29, 1997, August 20, 1997 and January 22, 1998.
3. The Company's Quarterly Report on Form 10-Q for the period ended September
30, 1997.
4. Amendment to the Company's Quarterly Report for the period ended September
30, 1997 on Form 10-Q/A filed on January 22, 1998.
5. The Current Reports on Form 8-K filed on January 22, 1998, November 14,
1997, November 3,1997, October 31, 1997, October 21, 1997, October 3, 1997
and October 1, 1997.
6. Amendment to the Company's Current Report filed on November 3, 1997 on Form
8-K/A filed on January 22, 1998.
7. Amendment to the Company's Current Report dated January 14, 1996 on Form
8-K/A filed on January 22, 1998.
8. The Company's Quarterly Report on Form 10-Q for the period ended June 30,
1997.
9. Amendment to the Company's Quarterly Report for the period ended June 30,
1997 on Form 10-Q/A filed on January 22, 1998.
10.The Definitive Proxy Statement for the Annual Meeting of the Company on
Schedule 14A, dated August 1, 1997.
11.The Definitive Proxy Statement for the Special Meeting of the Company's
Shareholders on Schedule 14A, dated January __, 1998.
12.The description of the Company's Common Stock contained in the Company's
registration statement under Section 12 of the Exchange Act, dated January
29, 1987, and any amendment or report updating such description, including
without limitation, Amendment No. 1 thereto dated October 5, 1987, Amendment
No. 2 thereto dated October 26, 1987, Amendment No. 3 thereto dated December
23, 1987, Amendment No. 4 thereto dated January 27, 1988 and Amendment No. 5
thereto dated February 9, 1988, the Company's Current Reports on Form 8-K
dated December 17, 1992, November 29, 1995 and December 14, 1995.
All reports and other documents subsequently filed by the Company pursuant to
Sections 13(a), 13(c), 14 and 15(d) of the Exchange Act, prior to the filing of
a post-effective amendment which indicates that all securities offered hereby
have been sold or which deregisters all securities then remaining unsold, shall
be deemed to be incorporated by reference in and to be a part of this
Prospectus from the date of filing of such reports and documents.
Any statement contained in a document incorporated or deemed to be incorporated
by reference herein shall be deemed to be modified or superseded for purposes
of this Prospectus to the extent that a statement contained herein or in the
Registration Statement containing this Prospectus or in any other subsequently
filed document which also is or is deemed to be incorporated by reference
herein modifies or supersedes such statement. Any statement so modified or
superseded shall not be deemed, except as so modified or superseded, to
constitute a part of this Prospectus. The Company will provide without
charge to each person to whom this Prospectus is delivered, upon the request
of such person, a copy of any or all of the foregoing documents referred to
above which have been or may be incorporated herein by reference, other than
exhibits to such documents (unless such exhibits are specifically
incorporated by reference into the information that this Prospectus
incorporates). Requests for such documents should be directed to the
Secretary of the Company at 7620 SW Bridgeport Road, Portland, Oregon 97224
(telephone number: (503) 639-7221).
THE COMPANY
Bioject develops, manufactures and markets a jet injection system for needle-
free drug delivery. Using this technology for injections virtually eliminates
the associated risk of contaminated needlestick injuries and resulting blood-
borne pathogen transmission, a major concern throughout the healthcare
industry. The Company manufactures and markets a professional jet injection
system, the Biojector 2000, which allows healthcare professionals to inject
medications through the skin, both intramuscularly in the deltoid muscle and
subcutaneously, without a needle. The Biojector 2000 system consists of two
components: a hand-held, reusable jet-injector; and a sterile, single-use
disposable syringe. The system is capable of delivering variable dose
needle-free injections up to 1 ml. Additionally, the Company has developed
a self-injection system for delivery of various medications up to 1 ml for
use by non-professionals and the Company is also developing systems for
Hoffmann-La Roche to use with certain of their products pursuant to an
agreement signed January 10, 1995.
The Company was formed in December 1992 for the sole purpose of acquiring all
the capital stock of Bioject Medical Systems Ltd. in a stock-for-stock
exchange in order to establish a U.S. domestic corporation as the publicly
traded parent company for Bioject Inc., an Oregon corporation formed in 1985,
and Bioject Medical Systems Ltd., a company organized under the laws of
British Columbia, Canada, and which was terminated in July 1996.
The Company's operations are conducted by Bioject Inc., an Oregon corporation,
which is a wholly-owned subsidiary of the Company. The Company also is the
majority owner of Bioject J.V. Subsidiary Inc. ("JV Sub"), a joint venture with
Elan International Services, Ltd. ("Elan"), a wholly-owned subsidiary of Elan
Corporation, plc ("Elan plc") which was formed in October 1997
for the purpose of researching, developing and commercializing a continuous
glucose monitoring system for diabetics. All references to the Company herein
are to Bioject Medical Technologies Inc. and its subsidiaries, unless the
context requires otherwise. The Company's executive offices and operations
are located at 7620 S.W. Bridgeport Road, Portland, Oregon 97224, and its
telephone number is (503) 639-7221.
"Biojector(R)" and "Bioject (R)" are trademarks of the Company.
RECENT DEVELOPMENTS
On September 30, 1997 pursuant to a letter agreement subsequently closed
on October 15, 1997, the Company completed a series of agreements (the "Elan
Transactions") with Elan, a drug delivery and biopharmaceutical company, for
the creation and funding of a joint venture for the research, development and
commercialization of a continuous glucose monitoring system for diabetics. In
connection with the Elan Transactions, Elan purchased 2,727,273 shares of
common stock of the Company at a price of $1.10 per share, which price was
determined by arms-length negotiation with Elan. The Company also granted to
Elan warrants to purchase 1.75 million shares of common stock at a price of
$2.50 per share. The exercise price of the warrant was determined by arms-length
negotiation with Elan. The Company was introduced to Elan by Raphael, LLC, a
management consulting firm. In return for such services, Raphael, L.L.C.
will receive a consulting fee of $150,000 and, subject to shareholder
approval, a warrant to purchase 100,000 shares of the Company's common stock.
The parties anticipate that an ambulatory monitoring system will
be developed under a license (the "License") granted by Elan
plc to JV Sub of certain patents and know-how (the "Technology")
related to systems for the continuous monitoring of glucose
levels in persons with diabetes. The system is expected to
include a patch-like sensor coupled with a wrist watch-type
monitoring device to measure glucose levels. The Company entered
into the Elan Transactions because it believes that the
technology is promising and brings the benefit of diversification
from the Company's dependence on jet injection technology, and
that these benefits justify assuming the obligations and risks
involved in the Elan Transactions.
The Company's subsidiary, JV Sub, is 80.1 percent owned by the
Company and 19.9 percent owned by Elan. The Company has invested
approximately $12.015 million in JV Sub's common stock and Elan has invested
approximately $3 million in JV Sub's common stock.
Elan loaned the Company the funds the Company has
invested in JV Sub. The loan is evidenced by a promissory note
issued by the Company (the "Note"). The Note bears interest
from and after October 15, 1997 at the rate of 9 percent until
December 31, 1997 and 12 percent thereafter. The Company has
sought shareholder approval to cancel the Note and exchange it
for the Company's Series A Convertible Preferred Stock and Series
B Convertible Preferred Stock. The $15 million invested by the
Company and Elan in JV Sub was paid to Elan as a license fee. In addition
to the initial license fee, JV sub is required under the license to pay
Elan plc an aggregate of $15.5 million in further royalties in stated amounts
as the following milestones are achieved: $1 million within 10 days of the
commencement of pivotal clinical trials; $1.5 million within 120 days of the
successful completion of the clinical trials; $3 million within 10 days of the
initial regulatory filing to obtain marketing approval; and $10 million within
120 days of the grant of U.S. marketing approval for the first product.
Subject also to shareholder approval, the Company intends to
obtain up to $4 million for its further investment in JV Sub's
capital stock from the sale to Elan of Series C Convertible
Preferred Stock or other similar series of preferred stock in
that amount. Subject to certain conditions, including approval
of the proposal by the Company's shareholders and the use of the
proceeds of the investment solely to fund such further
investments in JV Sub, the Company has the right to require Elan
to purchase such amount of the Series C Convertible Preferred
Stock or other similar series of preferred stock, at a price per
share equal to ten times the average market price of the
Company's Common Stock for a ten day period prior to the date of
issuance of the Series C Convertible Preferred Stock. Each
share of Series C Preferred Stock is convertible into ten shares
of Common Stock, subject to certain adjustments. The agreement
by Elan to purchase such Series C Convertible Preferred Stock
will expire 30 months after the date the Company's shareholders
approve the Proposal.
In September 1997 the Company issued to Robert R. Gonnelli, for his
assistance with the equity placement, a warrant to purchase a total of
350,000 shares of common stock of the Company, of which 200,000 may be
exercised at a price of $1.00 and the remainder at a price of $1.10.
In addition, upon the achievement of certain sales goals and other services
over the next two fiscal years, the Company will issue to Mr. Gonnelli
further warrants.
In June and July 1997, the Company completed a private placement (the
"Placement") of 2,906,977 units, each unit consisting of one share of Common
Stock and one warrant (a "Warrant") to purchase one-half share of Common Stock
at an exercise price of $0.71 per share. The Warrants, which are exercisable
in whole or from time to time in part, expire five years from the date of
issuance, and are transferable subject to compliance with all applicable
federal and state securities laws. Proceeds to the Company (excluding
estimated expenses) totalled $1,250,000. In May 1997, in return for services
provided, the Company granted to Amy Factor a warrant to purchase 25,000
shares of common stock at an exercise price of $0.50 per share.
RISK FACTORS
The Shares offered hereby involve a high degree of risk. In addition to the
other information in this Prospectus, the following factors should be
considered carefully in evaluating the Company and its business before making
an investment in the Shares offered hereby. This Registration Statement and
documents incorporated herein contain forward-looking statement within the
meaning of Section 27A of the Securities Act. Discussion containing such
forward-looking statements may be found in the material within this
Registration Statement generally as well as within the documents listed under
"Incorporation of Certain Documents by Reference" and documents subsequently
filed pursuant to Section 13(a), 13(c) 14 and 15(d) of the Exchange Act.
Actual results could differ materially from those projected in the
forward-looking statements as a result of the risk factors set forth below
and the matters set forth in the Registration Statement generally.
The Company cautions the reader that this list of factors
may not be exhaustive.
Uncertainty of Market Acceptance. The Company's success will depend
upon market acceptance of its jet injection drug delivery system, the
Biojector 2000 system, and, to a lesser extent, other products under
development. Currently, the dominant technology used for intramuscular
and subcutaneous injections is the hollow-needle syringe. Needle-syringes,
while low in cost, have limitations, particularly relating to contaminated
needlestick injuries. Use of the Biojector 2000 system for
intramuscular and subcutaneous injections virtually
eliminates the associated risk of these injuries; however, the cost per
injection is significantly higher. There can be no assurance that the
Biojector 2000 system will compete successfully. A previous jet injection
system manufactured by the Company did not achieve market acceptance and is
no longer being marketed. The Biojector 2000 was introduced in January 1993.
To date, the major portion of sales have been to HMI which were not placed
in service and which the Company has repurchased at a substantial
discount to the original selling price after the cancellation of its agreement
with HMI. Failure of the Biojector 2000 system to gain market acceptance would
have a material adverse effect on the Company's financial condition and results
of operations.
Uncertainty of New Product Development. The Company's joint
venture with Elan, JV Sub, intends to develop certain technology
licensed from Elan and to create an ambulatory monitoring system
which permits the continuous monitoring of glucose levels in
persons with diabetes. The system is in the early stages of
development, and there can be no assurance that JV Sub will be
successful in developing a product or that any such product can
be manufactured or marketed in a commercially viable manner. It
also is likely that significant additional levels of funding will
be required to develop the technology, which will require the
future issuance of debt or equity securities by either the
Company or JV Sub. Further, there can be no assurance that,
should a glucose monitoring system be developed, such system
would receive the requisite governmental clearance. See "-
Governmental Regulation."
History of Losses; Uncertain Profitability. Since its formation in 1985, the
Company has incurred significant annual operating losses and negative cash
flow. At March 31, 1997, the Company had an accumulated deficit of $34.2
million. The Company's revenues to date have been derived primarily from
licensing and technology fees, and from limited product sales, which were
principally sales to dealers for the stocking of inventories and to HMI.
More recently, the Company has sold its products to end users, primarily to
the public health clinics for vaccinations and nursing organizations for flu
immunizations, but the Company has not attained profitability on the basis
of these sales. There can be no assurance that the Company will be able to
generate significant revenues or achieve profitability.
Failure to Obtain Shareholder Approval of the Elan Transactions.
As discussed more fully above in "Recent Developments" and in
the documents incorporated herein by reference, the Company has
sought shareholder approval to cancel the Note and exchange it
for the Company's Series A and Series B Convertible Preferred
Stock. Should the Company not obtain shareholder approval,
it will be unable to cancel the Note and exchange it for the Series A and
Series B Convertible Preferred Stock. Instead, the Company will
be obligated to pay interest on the Note in cash and would remain
subject to the requirement to repay the principal when due, the
impact of which could materially affect the Company's liquidity
and operations. Also as part of the Elan transactions, the
Company has sought shareholder approval of the issuance to Elan
of the Company's Series C Convertible Preferred Stock or
substantially similar convertible preferred stock to fund the
Company's obligations to contribute capital to JV Sub to fund
future research in the field of glucose monitoring. Should the
Company not obtain shareholder approval of such issuance, the
Company would be required to find alternative sources of meeting
its financing commitments to JV Sub. No arrangements are in
place and no discussions have been initiated with respect to any
such financing. There can be no assurance that the Company would
succeed in obtaining alternative financing or that such financing
would be on favorable terms.
Possible Termination of the License. Pursuant to the terms of the
License, the License may be terminated under certain conditions. In the
event that 15% of JV Sub's equity is acquired by any one of a number of
specified companies identified by Elan as actual or potential competitors, or
any other entity to which Elan does not consent, which consent shall not be
unreasonably withheld in the case of such other, unspecified companies, the
License may be immediately terminated at Elan's option. Further, the License
itself is contingent, on a country-by-country basis, on JV Sub's diligently
seeking and obtaining regulatory marketing approval for licensed products and
on JV Sub's timely commercial launch of the licensed products in countries
where such approval has been obtained. Termination of the License may have a
material adverse effect on the Company's financial condition and results of
operations.
Need for Additional Financing. The Company's revenues from
operations have not been sufficient to satisfy its cash
requirements and it has relied upon the proceeds of sales of
equity securities to fund its operations. The Elan Transactions
involve significant financial commitments by the Company to fund
the activities of JV Sub, as well as significant payment
obligations by JV Sub to Elan as development milestones are met,
which are in addition to the Company's cash requirements relating
to its current activities involving jet injection technology.
Failure to obtain shareholder approval of the issuance to Elan of
Series A and Series B Convertible Preferred Stock in exchange for
the Note will obligate the Company to pay principal and interest
on the Note in cash. The Company plans to fund its cash
requirements through sales of equity securities, and anticipates
that JV Sub will fund its activities through the sales of equity
securities to the Company and Elan or to third parties. There
can be no assurance that adequate financing could be obtained on
favorable terms or at all. Failure to obtain adequate financing
would materially adversely affect the Company's business and
could result in defaults in the Company's or JV Sub's obligations
relating to the Elan Transactions, loss of JV Sub's rights to the
technology under the license, dilution of the Company's interest
in JV Sub or the need to curtail operations of the Company or JV
Sub due to inadequate cash resources or other adverse
consequences. The sale of equity securities on unfavorable terms
to meet the Company's obligations could result in material
dilution to the existing shareholders.
Effects of Convertible Preferred Stock. If the Company's
shareholders approve the issuance by the Company of Series A and
B Convertible Preferred Stock in exchange for the Note, the
Company's obligations under the Note will be extinguished, but
the Common Stock will be subject to the rights and preferences of
the Series A and B Convertible Preferred Stock, which will have a
liquidation preference of $12.015 million plus interest accrued
under the Note and accrued and unpaid dividends. Further, the
Series A and B Convertible Preferred Stock is convertible to
Common Stock at a conversion price of $1.50 per share at any
time, and at the end of seven years unless earlier converted by
the holders or redeemed by the Company, the shares Series A and B
Convertible Preferred Stock and accrued but unpaid dividends
convert automatically into Common Stock at the conversion price
equal to the lesser of $1.50 per share or 80% of the then
prevailing market price of Common Stock. Accordingly, conversion
of Series A and B Convertible Preferred Stock to Common Stock
could result in issuances of significant amounts of Common Stock
at deemed prices lower than prevailing market prices at the time
of conversion. Should the Company issue Series C Convertible
Preferred Stock or other similar series of Preferred Stock to
Elan to enable the Company to fund capital contributions to JV
Sub, the aggregate amount of Preferred Stock liquidation
preferences and Common Stock issuable upon conversion of
Preferred Stock would increase.
Limited Manufacturing Experience; Need to Reduce Unit Cost. The Company has
limited experience manufacturing its products in commercial quantities. The
Company has increased its production capacity for the Biojector 2000 system
through automation of, and changes in, production methods. The current cost
per injection of the Biojector 2000 system is substantially higher than that
of traditional needle-syringes, its principal competition. A key element of
the Company's business strategy is to reduce the overall system cost through
automating production and packaging. The Company has experienced and may
experience setbacks and delays in its cost reduction efforts including failure
to deliver reduced cost parts to specifications. There can be no assurance
that the Company will be able to develop and implement effective high volume
production or achieve necessary unit cost reductions. Failure to do either
would adversely affect the Company's financial condition and results of
operations.
Governmental Regulation. The Company's products and manufacturing operations
are subject to extensive government regulation, both in the U.S. and abroad.
In the U.S., the development, manufacture, marketing and promotion of medical
devices are regulated by the Food and Drug Administration ("FDA") under the
Federal Food, Drug, and Cosmetic Act ("FFDCA"). In 1987, the Company received
clearance from the FDA under Section 510(k) of the FFDCA to market a hand-held
CO2-powered jet injection system. The FFDCA provides that new premarket
notifications under Section 510(k) of the FFDCA are required to be filed when,
among other things, there is a major change or modification in the intended
use of a device or a change or modification to a legally marketed device that
could significantly affect its safety or effectiveness. A device
manufacturer is expected to make the initial determination as to whether
the change to its device or its intended use is of a kind that would
necessitate the filing of a new 510(k) notification. Although the Biojector
2000 system incorporates changes from the system with respect to which the
Company's 1987 510(k) marketing clearance was received and expands its
intended use, the Company made the determination that these were
not major changes or modifications in intended use or changes in the
device that could significantly affect the safety or
effectiveness of the device and that, accordingly, the 1987 510(k) clearance
permitted the Company to market the Biojector 2000 system in the U.S. In June
1994, the Company received clearance from the FDA under 510(k) to market a
version of its Biojector 2000 system in a configuration targeted at high
volume injection applications. In October 1996, the Company received 510(k)
clearance for a non-needle disposable vial access device. In March 1997, the
Company received additional 510(k) clearance for certain enhancements to its
Biojector 2000 system.
Future changes to manufacturing procedures could necessitate the filing of
a new 510(k) notification. Also, future products, product enhancements or
changes, or changes in product use may require clearance under Section
510(k), or they may require FDA premarket approval ("PMA") or other
regulatory approvals. PMAs and these other regulatory approvals generally
involve more extensive prefiling testing than a 510(k) clearance and a
longer FDA review process. Under current FDA policy, applications involving
prefilled syringes would be evaluated by the FDA as drugs rather than
devices, requiring FDA new drug applications ("NDAS") or ANDAs. Depending on
the circumstances, drug regulation can be more bureaucratic and time consuming
than devise regulation.
No approvals from the FDA have been obtained for the marketing of products
that may be developed based on glucose monitoring technology licensed from
Elan. The Company has not determined what FDA approvals are likely to be
required with respect to any products developed based on this technology, but
anticipates extensive testing and FDA review would be required of any such
product, and there can be no assurance that FDA approval could be obtained in
a timely manner or at all.
FDA regulatory processes are time consuming and expensive, and there can be no
assurance that product applications submitted by the Company will be cleared or
approved by the FDA. In addition, the Company's products must be manufactured
in compliance with Good Manufacturing Practices ("GMP") specified in
regulations under the FDA Act. The FDA has broad discretion in enforcing
the FDA Act, and noncompliance with the Act could result in a variety of
regulatory actions ranging from product detentions, device alerts or field
corrections, to mandatory recalls, seizures, injunctive actions, and civil
or criminal penalties.
Distribution of the Company's products in countries other than the U.S. may be
subject to regulation in those countries. An application was made to the
Japan Ministry of Health and Welfare to obtain necessary approvals to market
the Biojector 2000 system in Japan which was not carried to completion by the
Company's then Japanese distributor.
Possible Failure to Maintain Listing Criteria for Nasdaq Listing. So long as
the Note remains outstanding, and the Company does not obtain other substantial
equity financing, the Company will have negative net tangible assets. The
National Market requires as a condition of listing that listed
companies maintain net tangible assets of at least $4 million and the Nasdaq
SmallCap Market requires net tangible assets of $2 million.
While the Note remains outstanding the Company's net assets will
remain below these minimum requirements. Failure to obtain shareholder
approval of the proposal to cancel the Note and exchange it for preferred stock
could result in the delisting of the Company from NASDAQ, making trading in
the Company's securities more difficult. See "-Possible Adverse Effects on
Trading Market." If shareholder approval of the exchange is not obtained, the
Company would seek to take other actions including obtaining alternative
financing, or seeking approval from NASDAQ, to maintain listing eligibility,
but there can be no assurance that the Company would be successful in such
efforts or would be able to maintain the NASDAQ listing.
Uncertainty in Healthcare Industry. The healthcare industry is subject to
changing political, economic and regulatory influences that may affect the
procurement practices and operations of healthcare facilities. During the
past several years, the healthcare industry has been subject to increased
government regulation of reimbursement rates and capital expenditures. Among
other things, third party payors are increasingly attempting to contain
healthcare costs by limiting both coverage and reimbursement levels for
healthcare products and procedures. Because the price of the Biojector 2000
system exceeds the price of needle injection systems, cost control policies
of third party payors, including government agencies, may adversely affect
use of the Biojector 2000 system.
Dependence on Third-Party Relationships. The Company is dependent on third
parties for distribution of the Biojector 2000 system to certain market
segments, for the manufacture of component parts, and for assistance with the
development and distribution of its future Betaseron self-injection and
application specific systems.
The Company's current manufacturing processes for the Biojector 2000 jet
injector and disposable syringes consist primarily of assembly of component
parts supplied by outside suppliers. Certain of these components are currently
obtained from single sources, with some components requiring significant
production lead times. In the past, the Company has experienced delays in the
delivery of certain components, although to date no such delays have had a
material adverse effect on the Company's operations. There can be no assurance
that the Company will not experience delays in the future, or that such delays
would not have a material adverse effect on the Company's financial condition
and result of operations.
The Company has entered into agreements with certain major pharmaceutical
companies for development and distribution of jet injection systems and for
the development and commercialization of a continuous glucose monitoring
system. These companies have the right to terminate these agreements at
certain phases as defined in the agreements. There can be no assurance
these companies' interest and participation in the projects will continue.
Failure to receive additional funding from these companies could adversely
affect the development and production of the products involved and,
correspondingly, the Company's financial condition and results of operations.
Ability to Manage Growth. If the Company's products achieve market
acceptance, the Company expects to achieve rapid growth. This growth strategy
will require expanded customer services and support, increased personnel
throughout the Company, expanded operational and financial systems, and the
implementation of new control procedures. There can be no assurance that the
Company will be able to attract qualified personnel or successfully manage
expanded operations. As the Company expands, it may from time to time
experience constraints that would adversely affect its ability to satisfy
customer demand in a timely fashion. Failure to manage growth effectively
could adversely affect the Company's financial condition and results of
operations.
Competition. The medical equipment market is highly competitive and
competition is likely to intensify. The Company's products compete
primarily with traditional needle-syringes, "safety syringes" and also with
other alternative drug delivery systems. While the Company believes its
products provide a superior drug delivery method, there can be no assurance
that the Company will be able to compete successfully with existing drug
delivery products. Many of the Company's competitors have longer operating
histories as well as substantially greater financial, technical, marketing
and customer support resources than the Company. There can be no assurance
that one or more of these competitors will not develop an alternative drug
delivery system that competes more directly with the Company's products, or
that the Company's products would be able to compete successfully with such a
product. Further, should JV Sub develop an ambulatory glucose monitoring
system which obtains all necessary regulatory clearance, there can be no
assurance that either the Company's or JV Sub's competitors will not develop
other competing systems, or that JV Sub's system would be able to compete
successfully with other systems or products.
Dependence on Two Technologies. The Company's strategy has been to focus its
development and marketing efforts on its jet injection technology, and the
strategy of its Joint Venture with Elan is to focus on the development and
commercialization of a continuous glucose monitoring system. This focus
renders the Company particularly sensitive to competing products and
alternative drug delivery systems, as well as to alternative methods to
monitor glucose levels in diabetics. The Company believes that healthcare
providers' desire to minimize the use of the traditional needle-syringe has
stimulated development of a variety of alternative drug delivery systems such
as "safety syringes," jet injection systems and transdermal diffusion
"patches." In addition, pharmaceutical companies frequently attempt to
develop drugs for oral delivery instead of injection.
While the Company believes that for the foreseeable future there will continue
to be a significant need for injections, there can be no assurance that
alternative drug delivery methods will not be developed which are preferable
to injection. Further, there can be no assurance that alternative glucose
monitoring systems will not be developed which are preferable to that to be
developed by the Company's Joint Venture with Elan.
Patents and Proprietary Rights. The Company relies on a combination of trade
secrets, confidentiality agreements and procedures, and patent prosecution to
protect its proprietary technologies. The Company has been granted seven
patents in the United States and two patents in certain other countries
covering certain technology embodied in its current jet injection system and
certain manufacturing processes. Additional patent applications are pending
in the U.S. and certain foreign countries. There can be no assurance that
the claims contained in any patent application will be allowed, or that any
patent will provide adequate protection for the Company's products and
technology. In the absence of patent protection, the Company may be
vulnerable to competitors who attempt to copy the Company's products or
gain access to its trade secrets and know-how. In addition, the laws of
foreign countries may not protect the Company's proprietary rights to
this technology to the same extent as the laws
of the U.S. The Company believes that it has independently developed its
technology and attempts to ensure that its products do not infringe the
proprietary rights of others, and the Company knows of no infringement claims.
However, any such claims could have a material adverse affect on the Company's
financial condition and results of operations.
Product Liability. Producers of medical devices may face substantial
liability for damages in the event of product failure or if it is alleged
the product caused harm. The Company currently maintains product liability
insurance and has not experienced any product liability claims to date.
There can be no assurance, however, that the Company will not be subject to
such claims, that the Company's current insurance would cover such claims,
or that adequate insurance will continue to be available on acceptable terms
to the Company in the future. The Company's business could be adversely
affected by product liability claims.
Dependence upon Key Employees. The Company's success is dependent upon the
retention of its executive officers and other key employees. Competition
exists for qualified personnel and the Company's success will depend in
part upon attracting and retaining such personnel. Failure in these efforts
could have a material adverse effect on the Company's business, financial
condition or results of operations.
Shares Eligible For Future Sale. In November and December 1995, the Company
completed a private placement of 2,303,009 units (each unit representing one
share of common stock and a warrant to purchase three-quarters of one share of
common stock). The Company also granted a warrant to its placement agent in
the private placement to purchase 137,086 shares of common stock. The shares
issued in the 1995 private placement were registered for resale on a
Registration Statement on Form S-3. In December 1996, the Company
completed a private placement of 3,434,493 units (each unit representing one
share of common stock and a warrant to purchase one share of common stock).
The Company also granted a warrant to its placement agent in the private
placement to purchase 156,000 shares of common stock. The shares issued in
the private placement and the underlying shares issuable upon exercise of the
warrants were registered for resale on a Form S-3 registration statement.
In June and July 1997, the Company completed a private placement of 2,906,977
units, each unit consisting of one share of Common Stock and one warrant to
purchase one-half share of Common Stock. In May 1997, in return for services
provided, the Company granted to Amy Factor a warrant to purchase 25,000
shares of Common Stock. The shares issued in the private placement and
the underlying shares issuable upon exercise of the
warrants were registered for resale on a Form S-3 registration statement. In
connection with the Elan Transactions in October 1997, Elan purchased 2,727,273
shares of Common Stock and was granted a five year warrant to purchase 1.75
million shares of common stock. The Company also will grant to Raphael,
L.L.C., a management consulting company which introduced Elan to the Company, a
warrant to purchase 100,000 shares of Common Stock, subject to shareholder
approval. See "Recent Developments." In each of the private placements and
in the Elan Transactions, the Company also granted registration rights with
respect to the shares issuable upon exercise of the warrants. Sales of
substantial numbers of common stock in the public market, or the availability
of such shares for sale, could adversely affect the market price for the
common stock and make it more difficult for the Company to raise funds
through equity offerings in the future.
Possible Adverse Effects on Trading Market. The Common Stock is quoted on the
NASDAQ National Market. There are a number of continuing requirements that
must be met in order for the Common Stock offered hereby to remain eligible
for quotation on the NASDAQ National Market or the NASDAQ SmallCap Market. In
August 1997, NASDAQ approved changes to its quantitative and qualitative
standards for issuers listing on NASDAQ. Among the changes are the
elimination of the alternative test for issuers failing to meet the minimum
bid price of $1.00 and an increase in the quantitative standards for both the
NASDAQ National Market and the NASDAQ SmallCap Market. The Company intends
to call a Special Meeting of its shareholders to approve a proposal relating
to the Elan Transaction, including the conversion of a promissory note into
convertible preferred stock. If shareholder approval for the proposal is not
obtained, the Company may be subject to delisting due to failure to maintain
the quantitative requirements set forth by NASDAQ. See "-Possible Failure to
Maintain Listing Criteria for NASDAQ Listing".
The failure to meet the maintenance criteria in the future could result in the
delisting of the Company's Common Stock from NASDAQ. In such event, trading,
if any, in the Common Stock may then continue to be conducted in the non-
NASDAQ over-the-counter market. As a result, an investor may find it more
difficult to dispose of, or to obtain accurate quotations as to the market
value of, the Company's Common Stock. In addition, if the Common Stock were
delisted from trading on NASDAQ and the trading price of the Common Stock
were less than $5.00 per share, trading in the Common Stock would also be
subject to the requirements of certain rules promulgated under the Exchange
Act, which require additional disclosure by broker-dealers in connection
with any trades involving a stock defined as a penny stock. The additional
burdens imposed upon broker-dealers may discourage broker-dealers from
effecting transactions in penny stocks, which could reduce the liquidity
of the shares of Common Stock and thereby have a
material adverse effect on the trading market for the securities.
Possible Volatility of Stock Price. The market for the Company's Common Stock
and for the securities of other early stage, small market-capitalization
companies has been highly volatile in recent years. The Company believes that
factors such as quarter-to-quarter fluctuations in financial results, new
product introductions by the Company or its competition, public announcements,
changing regulatory environments, sales of Common Stock by certain existing
shareholders and substantial product orders could contribute to the volatility
of the price of the Company's Common Stock, causing it to fluctuate
dramatically. General economic trends such as recessionary cycles and
changing interest rates may also adversely affect the market price of the
Company's Common Stock.
USE OF PROCEEDS
The Shares offered hereby are being registered for the account of the Selling
Shareholders and, accordingly, the Company will not receive any of the
proceeds from the sale of the Shares.
SELLING SHAREHOLDERS
The Shares being offered for resale by the Selling Shareholders were acquired
either in connection with the Elan Transactions and include the Common Stock
sold or issued thereunder or upon conversion of outstanding debt to Schering
AG into shares of the Company's common stock pursuant to the terms of the
Development and Licensing Agreement with Schering AG and the Supply Agreement
with Schering AG (the "Conversion"). The term "Selling Shareholder" includes
all persons acquiring securities in the Elan Transactions and in the
Conversion and persons acquiring such securities in permitted transfers
from original holders thereof pursuant to the Registration Rights Agreement
and the Development and Licensing Agreement (described below) in transactions
not requiring registration under the Securities Act.
The Company granted the Selling Shareholders certain "piggyback" registration
rights in connection with the registration under the Securities Act of
securities in connection with a public offering (other than a registration
relating to the sale of securities solely to participants in employee benefit
plans or in connection with certain transactions requiring shareholder
approval). All rights granted pursuant to the Registration Rights Agreement
in the Elan Transaction terminate at such time as each holder under the
Registration Rights Agreement has sold all registrable securities pursuant to
a registration statement, Rule 144, Regulation S, or a similar provision
under the Securities Act so that there is no further restriction on the
transfer by the transferee.
The following table sets forth certain information regarding the beneficial
ownership of shares of Common Stock by the Selling Shareholders as of October
28, 1997, and as adjusted to reflect the sale of the Shares.
Number of Shares Maximum Number of Share Owned
Owned Shares to be Sold After Offering (1)
Name Prior to Offering under this Prospectus Number Percent
Schering AG 487,390 487,390 0 *
Elan International 4,477,273 2,727,273 1,750,000 6.5
Services, Ltd. (2)
Total 4,964,663 3,214,663 1,750,000
_________________
* Less than 1%.
(1) Assumes that all of the Selling Shareholders will sell all Shares during
the effective period.
(2) Includes (i) 2,727,273 shares of Common Stock and (ii) 1,750,000 shares of
Common Stock issuable upon exercise of a warrant.
No Selling Shareholder has held any position or office, or other material
relationship with the Company or any of its predecessors or affiliates within
the past three years.
PLAN OF DISTRIBUTION
The distribution of the Shares by the Selling Shareholders may be effected
from time to time in one or more transactions (which may involve block
transactions), in special offerings, exchange distributions and/or secondary
distributions, in negotiated transactions, or a combination or such methods
of sale, at market prices prevailing at the time of sale, at prices related
to such prevailing market prices or at negotiated prices. Such transactions
may be effected on a stock exchange or the over-the-counter market. The
Selling Shareholders may effect such transactions by selling the Shares to
or through broker-dealers, and such broker-dealers may receive compensation
in the form of underwriting discounts, concessions or commissions from one or
more of the Selling Shareholders for whom they may act as agent (which
compensation may be in excess of customary commissions). Without limiting
the foregoing, such brokers may act as dealers by purchasing any and all of
the Shares covered by this Prospectus either as agents for others or as
principals for their own accounts and reselling such securities pursuant to
this Prospectus. The Selling Shareholders and any broker-dealers or other
persons acting on the behalf that participate with such Selling Shareholders
in the distribution of the Shares may be deemed to be underwriters and any
commissions received or profit realized by them on the resale of the Shares
may be deemed to be underwriting discounts and commissions under the
Securities Act. As of the date of this Prospectus, the
Company is 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 pursuant to this Prospectus.
At the time that any particular offering of Shares is made, to the extent
required by the Securities Act, a prospectus supplement will be distributed,
setting forth the terms of the offering, including the aggregate number of
Shares being offered, the names of any underwriters, dealers or agents, any
discounts, commissions and other items constituting compensation from the
Selling Shareholders and any discounts, commissions or concessions allowed or
reallowed or paid to dealers.
The Selling Shareholders may from time to time pledge the Shares owned by them
to secure margin or other loans made to one or more of the Selling
Shareholders. Thus, the person or entity receiving the pledge of any of
the Shares may sell them, in a foreclosure sale or otherwise, in the same
manner as described above for a Selling Shareholder.
The Company will not receive any of the proceeds from any sale of the Shares
by the Selling Shareholders offered hereby.
Pursuant to the Registration Rights Agreement, the Company has agreed to
indemnify the Selling Shareholders against certain liabilities, including
liabilities under the Securities Act. The Company shall bear customary
expenses incident to the registration of the Shares for the benefit of the
Selling Shareholders in accordance with the Registration Rights Agreement,
other than underwriting discounts and commissions directly attributable to
the sale of such securities by or on behalf of the Selling Shareholders.
The Company has agreed to use its best efforts to keep the Registration
Statement of which this Prospectus is a part effective for at least two years
from January __, 1998.
LEGAL MATTERS
The validity of the issuance of the shares of Common Stock offered hereby will
be passed upon for the Company by Bogle & Gates P.L.L.C., Seattle, Washington.
EXPERTS
The consolidated financial statements and schedule incorporated by reference
in this Prospectus and elsewhere in the Registration Statement have been
audited by Arthur Andersen LLP, independent public accountants, as indicated
in their reports with respect thereto, and are incorporated by reference
herein in reliance upon the authority of said firm as experts in accounting
and auditing in giving said reports.
Future financial statements of the Company and the reports thereon of Arthur
Andersen LLP also will be incorporated by reference in this Prospectus in
reliance upon the authority of that firm as experts in accounting and auditing
in giving those reports to the extent said firm has audited those financial
statements and consented to the use of their reports thereon.
_____________________________________________________________________________
No dealer, salesperson, or any other person
has been authorized to give any information or
to make any representations other than those 3,214,663 Shares
contained in this Prospectus in connection
contained herein, and, if given or made, such Common Stock
information or representations must not be (without par value)
relied upon as having been authorized by the
Company. This Prospectus does not constitute
an offer of any securities other than those to
which it relates or an offer to sell, or a
solicitation of an offer to buy, those to which
it relates in any jurisdiction where, or to any
person to whom, it is unlawful to make such an
offer. The delivery of this Prospectus at any
time does not imply that there has been no change
in the information set forth herein or in the
affairs of the Company since the date hereof.
________________________
TABLE OF CONTENTS
________________________
BIOJECT MEDICAL
TECHNOLOGIES INC.
Page
Available Information 2
Incorporation of Certain Documents by
Reference 2
The Company 3
Recent Developments 3
Risk Factors 4
Use Of Proceeds 7
Selling Shareholders 7
Plan of Distribution 8
Legal Matters 9
Experts 9
________________
PROSPECTUS
________________
January __, 1998
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
ITEM 14. OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION.
The following table itemizes the expenses incurred by the Company in
connection with the shares of Common Stock being registered. All of the
amounts shown are estimates except the Securities and Exchange registration
fee.
Item Amount
Securities and Exchange Commission Registration Fee $ 1,490.43
Blue Sky Fees and Expenses 0.00
Accounting Fees and Expenses 5,000.00
Legal Fees and Expenses 10,000.00
Miscellaneous 0.00
Total $ 16,490.43
_________________________
The Selling Shareholders will pay no portion of the foregoing expenses.
ITEM 15. INDEMNIFICATION OF DIRECTORS AND OFFICERS.
Generally, Sections 60.387 through 60.414 of the Oregon Business Corporation
Act(the "Act") authorize a court to award, or a corporation's board of
directors to grant, indemnification to directors and officers in circumstances
where the officer or director acted in good faith, in a manner that the
director or officer reasonably believed to be in (or at least not opposed to)
the best interests of the corporation and, if in a criminal proceeding, if
the director or officer had no reasonable cause to believe his conduct was
unlawful. Article IX of the Company's Bylaws provides for indemnification to
the greatest extent permitted by the Oregon Act.
Section 60.047 of the Oregon Act authorizes a corporation to limit a
director's liability to the corporation or its shareholders for monetary
damages resulting from conduct as a director, except in certain circumstances
involving breach of the director's duty of loyalty to the corporation or its
shareholders, intentional misconduct or knowing violation of the law, self
dealing or approval of illegal corporate loans or distributions, or any
transaction from which the director personally receives a benefit in money,
property or services to which the director is not legally entitled. Article
VII of the Company's Articles of Incorporation contains provisions
implementing, to the fullest extent allowed, limitations on a director's
liability to the Company or its shareholders. The Company currently
maintains officers' and directors' liability insurance.
(a) EXHIBITS.
Exhibit
Number Description
4.1 Registration Rights Agreement dated October 15, 1997 (Incorporated
by reference to Exhibit 10.42 of the Registrant's Current Report on
Form 8-K dated October 31, 1997 (the "Form 8-K")
4.2 Securities Purchase Agreement dated October 15, 1997 (Incorporated
by reference to Exhibit 10.41 of the Form 8-K)
4.3 Form of Series K Common Stock Purchase Warrant dated October 15,
1997 (Incorporated by reference to Exhibit 10.43 of the Form 8-K)
4.4 Development and Licensing Agreement between Schering AG, Bioject
Inc. and Bioject Medical Technologies Inc. dated March 28, 1994
(Incorporated by reference to Exhibit 10.23 to the Company's Form
10-K for the year ended March 31, 1994) Confidential treatment
has been granted with respect to certain portions of this exhibit
pursuant to an Application for Confidential Treatment filed with
the Commission under Rule 24b-2 under the Securities exchange Act
of 1934, as amended.
4.5 Supply Agreement dated June 26, 1996 between Bioject Inc. and
Schering AG (Incorporated by reference to Exhibit 10.32 to the
Company's Form 8-K/A dated June 26, 1996). Confidential treatment
has been granted with respect to certain portions of this exhibit
pursuant to an Application for Confidential Treatment filed with
the Commission under Rule 24b-2 under the Securities exchange Act
of 1934, as amended.
5.1 Opinion of Bogle & Gates P.L.L.C.
23.1 Consent of Bogle & Gates P.L.L.C. (included in Exhibit 5.1)
23.2 Consent of Arthur Andersen LLP
24.1 Power of Attorney (see Signatures page of the Company's Form S-3
(No.333-39421) filed on November 4, 1997).
ITEM 17 UNDERTAKINGS.
(a) Rule 415 Offering.
The undersigned Registrant hereby undertakes:
(1) To file, during any period in which offers or sales are being made,
a post-effective amendment to this Registration Statement;
(i) To include any prospectus required by Section 10(a)(3) of the Securities
Act of 1933;
(ii) To reflect in the prospectus any facts or events arising after the
effective date of 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. Notwithstanding the foregoing, any increase or
decrease in volume of securities offered (if the total dollar value of
securities offered would not exceed that which was registered) and any
deviation from the low or high and of the estimated maximum offering range
may be reflected in the form of prospectus filed with the Commission pursuant
to Rule 424(b) if, in the aggregate, the changes in volume and price represent
no more than 20 percent change in the maximum aggregate offering price set
forth in the "Calculation of Registration Fee" table in the effective
registration statement.
(iii) To include any material information with respect to the plan of
distribution not previously disclosed in this Registration Statement or any
material change to such information in this Registration Statement;
provided, however, that the undertakings set forth in paragraphs (a)(1)(i) and
(a)(1)(ii) above do not apply if this Registration Statement is on Form S-3,
Form S-8 or Form F-3, and the information required to be included in a post-
effective amendment by those paragraphs is contained in periodic reports filed
by the Registrant pursuant to Section 13 or Section 15(d) of the Securities
Exchange Act of 1934 that are incorporated by reference in this 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 as that time shall be deemed to be the initial
bona fide offering thereof;
(3) To remove from registration by means of post-effective amendment any of
the securities being registered which remain unsold at the termination of the
offering.
(b) Filings Incorporating Subsequent Exchange Act Documents by Reference.
The undersigned Registrant hereby undertakes that, for the 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.
(h) Indemnification for Liabilities.
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 provisions described in Item 15 above, or
otherwise, the Registrant has been advised that in the opinion of the
Securities and Exchange Commission such indemnification is against public
policy as expressed in the 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 expense incurred
or paid by a director, officer or controlling person of the Registrant in
the successful defense of any action, suit or proceeding) is asserted by
such director, officer or controlling person in connection with the
securities being registered, the Registrant will, unless
in the opinion of its counsel the matter has been settled by controlling
precedent, submit to a court of appropriate jurisdiction the question whether
such indemnification by it is against public policy as expressed in the
Securities Act of 1933 and will be governed by the final adjudication of such
issue.
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 Registration
Statement to be signed on its behalf by the undersigned, thereunto duly
authorized, in the City of Portland, State of Oregon, on January 22, 1998.
BIOJECT MEDICAL TECHNOLOGIES INC.
BY:/s/ Peggy J. Miller
Peggy J. Miller
Vice President and
Chief Financial Officer
Pursuant to the requirements of the Securities Act of 1933, this Registration
Statement has been signed by the following persons in the capacities and on
the dates indicated.
Signature Title Date
/s/ * Chairman of the Board, Chief
James C. O'Shea Executive Officer and President
(Principal Executive Officer) January 22, 1998
/s/Peggy J. Miller Vice President, Chief Financial
Peggy J. Miller Officer and Secretary/Treasurer
(Principal Accounting and
Financial Officer) January 22, 1998
/s/* Director January 22, 1998
William A. Gouveia
/s/* Director January 22, 1998
John Ruedy, M.D.
/s/* Director January 22, 1998
Grace Keeney Fey
/s/* Director January 22, 1998
Eric T. Herfindal
/s/*
David de Weese Director January 22, 1998
/s/* Director January 22, 1998
Richard J. Plestina
/s/*
Michael Sember Director January 22, 1998
*By /s/ Peggy J. Miller
Peggy J. Miller
Attorney-in-fact
INDEX TO EXHIBITS
Exhibit
Number Description
23.2 Consent of Arthur Andersen LLP
<PAGE>
Exhibit 23.2
CONSENT OF INDEPENDENT PUBLIC ACCOUNTANTS
As independent public accountants, we hereby consent to the incorporation by
reference in this Form S-3 Registration Statement of our report dated
May 2, 1997 included in the Bioject Medical Technologies, Inc. Annual
Report on Form 10-K for the fiscal year ended March 31, 1997 and to all
references to our firm included in this Registration Statement
/s/ Arthur Andersen, LLP
Portland, Oregon
January 21, 1998
