As filed with the Securities and Exchange Commission on September 11, 1998.
Registration No. 333-62889
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
____________________
(Amendment No. 1)
FORM S-3/A
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. [ ] _________
<PAGE>
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.
PROSPECTUS
200,000 SHARES
BIOJECT MEDICAL TECHNOLOGIES INC.
COMMON STOCK
_____________________
This Prospectus pertains to the offer and sale from time to time of up to
200,000 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 Shareholder against certain liabilities, including
liabilities under the Securities Act. See "Selling Shareholder" and "Plan of
Distribution."
The Common Stock is quoted on the NASDAQ National Market under the symbol
"BJCT". On September 10, 1998, the closing bid price of the Common Stock as
reported by NASDAQ was $1.00.
_____________________
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 Shareholder to reject any order in whole or in part.
The date of this Prospectus is September 11, 1998.
<PAGE>
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.
<PAGE>
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/A for the year ended March 31, 1998.
2. The Definitive Proxy Statement for the Annual Meeting of the Company on
Schedule 14A, dated August 4, 1998.
3. 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 and subcutaneously, without a needle. The
Biojector 2000 system consists of two components: a hand-held, reusable
jet-injector (the "Biojector 2000"); and a sterile, single-use disposable
syringe ("Biojector 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. 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. On March 23, 1998 the Company entered into a transaction with Vitajet
Corporation ("Vitajet") whereby the Company acquired, along with certain other
assets, the rights to the Vitajet(R), a spring-powered self-injection device
which currently has regulatory clearance for administering injections of
insulin. In October 1997, the Company entered into a joint development agreement
with Elan Corporation, plc ("Elan") for the license (the "License") of certain
blood glucose monitoring technology from Elan and the development and
commercialization of that technology by a newly formed subsidiary of the Company
(the "Elan Transaction"). In July 1998, the Company entered into an agreement
with Merck & Co. ("Merck") which provides Merck the rights to use the Biojector
2000 jet injection system with selected Merck vaccines. Also in July 1998, the
Company and GeneMedicine, Inc. ("GeneMedicine") entered into a collaborative
research agreement involving GeneMedicine's technology and the Company's
needle-free injection technology. The Company intends to operate as two distinct
business segments: the jet-injection business and the blood glucose monitoring
business.
<PAGE>
The Company's needle-free jet injection operations are conducted by Bioject
Inc., an Oregon corporation, which is a wholly-owned subsidiary of the Company.
The Company's blood glucose monitoring system development operations are
conducted by a subsidiary, Bioject JV Subsidiary Inc., an Oregon corporation.
Although Bioject Inc. commenced operations in 1985, the Company was formed in
December 1992 for the sole purpose of acquiring all the capital stock of Bioject
Medical Systems Ltd., a company organized under the laws of British Columbia,
Canada, in a stock-for-stock exchange in order to establish a U.S. domestic
corporation as the publicly traded parent company for Bioject Inc. and Bioject
Medical Systems Ltd. Bioject Medical Systems Ltd. was terminated in fiscal 1997.
Bioject JV Subsidiary Inc. ("JV" or "JV Sub") was formed in October 1997 for the
purpose of developing and commercializing the blood glucose monitoring
technology. 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," "Bioject," "Vitajet" and "Medivax" are registered trademarks of the
Company.
FORWARD-LOOKING STATEMENTS
Certain statements in this Registration Statement and the documents incorporated
by reference to this Registration Statement constitute "forward-looking
statements" within the meaning of the Private Securities Litigation Reform Act
of 1995. Any statements that express or involve discussions with respect to
predictions, expectations, beliefs, plans, projections, objectives, assumptions
or future events or performance (often, but not always, using words or phrases
such as "expects" or "does not expect," "is expected," "anticipates" or "does
not anticipate," "plans," "estimates" or "intends," or stating that certain
actions, events or results "may," "could," "would," "might" or "will" be taken,
occur or be achieved) are not statements of historical fact and may be
"forward-looking statements." Such forward-looking statements involve known and
unknown risks, uncertainties and other factors which may cause the actual
results, performance or achievements of the Company, or industry results, to be
materially different from any future results, performance, or achievements
expressed or implied by such forward-looking statements. Such risks,
uncertainties and factors include, among others, those described under "Risk
Factors" and identified as risks or uncertainties in the documents incorporated
by reference.
RISK FACTORS
Investment in the securities of the Company involves a high degree of risk. In
addition to the other information in this annual report, the following factors
should be considered carefully in evaluating the Company and its business. 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,
the blood glucose monitoring 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 Homecare Management, Inc. ("HMI"),
which units 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.
<PAGE>
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 blood
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 complete development of the technology,
which will likely 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
blood glucose monitoring system be developed, such system would receive the
requisite governmental clearance.
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, 1998, the Company had an accumulated deficit of $50.9 million, $12
million of which related to the fiscal 1998 write-off, after minority interest,
of in-process research and development acquired in connection with the
acquisition of blood glucose monitoring technology from Elan. Historically, the
Company's revenues 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 public health clinics for vaccinations and
to nursing organizations for flu immunizations. The Company has not attained
profitability at these sales levels. There can be no assurance that the Company
will be able to generate significant revenues or achieve profitability.
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 clearance for licensed products and on JV Sub's timely
commercial launch of the licensed products in countries where such clearance 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 on the
proceeds of sales of equity securities to fund its operations. The Elan
Transaction involves significant future financial commitments by the Company to
fund the development and marketing activities of JV Sub, as well as significant
payment obligations, totaling $15.5 million, by JV Sub to Elan as product
development milestones are met. These payment obligations are in addition to the
Company's cash requirements relating to current activities involving the
Company's jet injection technology. The Company plans to fund its cash
requirements through revenues, debt and sales of equity securities, and
anticipates that JV Sub will fund its activities through debt and sales of
equity securities to the Company and Elan or to third parties. There can be no
assurance that financing sufficient to fund either the Company's jet injection
business activities or blood glucose monitoring business activities will be
obtained on favorable terms or at all. Failure to obtain adequate financing
would have a material adverse impact on the Company's business and could result
in defaults on 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.
<PAGE>
Effects of Convertible Preferred Stock. The Company's Common Stock is subject to
the rights and preferences of the Company's Series A and B Convertible Preferred
Stock, which has a liquidation preference of $12.405 million plus 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 of 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 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 commercially viable 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 has been to reduce the overall manufacturing cost
through automating production and packaging. 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. While the
Company believes that its experience manufacturing the Biojector enhances the
probability of its success in manufacturing the Vitajet, the Company has no
experience manufacturing the Vitajet and as of September 4, 1998 has not
installed a manufacturing line to produce the Vitajet. There can be no assurance
that the Company will be able to successfully manufacture the Vitajet at a unit
cost that will allow the product to be sold profitably. Failure to do so would
adversely affect the Company's financial condition and results of operation.
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 ("FD&C"). In 1987, the Company received clearance
from the FDA under Section 510(k) of the FD&C to market a hand-held CO2-powered
jet injection system. The FD&C provides that new premarket notifications under
Section 510(k) of the FD&C 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.
Accordingly, the Company further concluded that 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 needle-free disposable vial access device. In March 1997, the Company
received additional 510(k) clearance for certain enhancements to its Biojector
2000 system. The Company currently has applications pending before the FDA for
510(k) clearance of the B2020 1.5ml jet injector and the B4000 self-injector.
There can be no assurance that the FDA will concur with the Company's
determination that the products can be qualified by means of a 510(k)
submission.
<PAGE>
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 clearances. PMAs and
regulatory clearances other than 510(k) clearance 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 much more extensive and time consuming than device regulation.
No clearances from the FDA have been obtained for the marketing of products that
may be developed based on the blood glucose monitoring technology licensed from
Elan. The Company is researching and has not finally determined which FDA
clearances will be required with respect to any products developed based on this
technology. MiniMed, Inc., developer of a continuous glucose sensor system which
had been submitted to the FDA for clearance under a 510(k) notification was
advised in July 1998 that the FDA would require regulatory submission under the
PMA regulatory pathway. Because the Company has allowed a significant amount of
time in its product development schedule for submitting to the FDA for
regulatory clearance, it believes that if the FDA requires a PMA rather than a
510(k) submission, the overall product development schedule may not be adversely
affected. Whatever level of regulatory submission is required, the Company
anticipates that extensive testing and regulatory review will be required of the
Company's blood glucose monitoring product. There can be no assurance that the
regulatory review process will not cause significant delays in the product
development schedule or that regulatory clearance will be obtained at all.
FDA regulatory processes are time consuming and expensive. 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") as 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 current Japanese distributor.
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 or reduce healthcare
costs by limiting both coverage and levels of reimbursement 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 future application-specific systems.
The Company's current manufacturing processes for the Biojector 2000 jet
injector and disposable syringes as well as manufacturing processes anticipated
to produce the Vitajet consist primarily of assembling 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.
<PAGE>
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 blood 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 that these
companies' interest and participation in the projects will continue. Failure to
receive additional funding from these companies under certain of the agreements
or terminations of these agreements 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 and expanded 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 blood glucose monitoring system which obtains all
necessary regulatory clearances, 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. The strategy
of its Joint Venture with Elan is to focus on development and commercialization
of a continuous blood glucose monitoring system. Focus on these two technologies
leaves the Company vulnerable to competing products and alternative drug
delivery systems, as well as to alternative methods to monitor blood 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. The Company also believes that there will be high market
demand for a minimally invasive blood glucose monitoring system such as that
being developed by the Company and that the size of that market will likely
attract significant competition to the Company's blood glucose monitoring
product.
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 blood glucose
monitoring systems will not be developed which are preferable to that to be
developed by the Company.
<PAGE>
Patents and Proprietary Rights. The Company relies on a combination of trade
secrets, confidentiality agreements and procedures, and patents to protect its
proprietary technologies. The Company has been granted a number of patents in
the United States and several 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, attempts to ensure that its products do not infringe the proprietary
rights of others and the Company knows of no such 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,
to-date, has not experienced any product liability claims. 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 depends on the retention of
its executive officers and other key employees. Competition exists for qualified
personnel and the Company's success will depend, in part, on 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 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. In January, 1998, the shares issued to Elan as
well as the 487,390 shares issued to Schering were registered for resale on a
Form S-3 registration statement. In October, 1997, the Company granted warrants
to purchase 350,000 shares of stock to Robert Gonnelli in connection with his
guarantee of an equity investment in the Company. In February, 1998, the Company
granted Raphael, L.L.C. ("Raphael"), a management consulting company which
introduced Elan to the Company, a warrant to purchase 100,000 shares of Common
Stock. In March, 1998, in connection with the transaction with Vitajet, the
Company issued Vitajet 100,000 shares of Common Stock. Subsequent to year-end,
in June, 1998, the Company granted warrants to purchase 130,243 shares of stock
to Robert Gonnelli in return for services to the Company. Also in June, 1998,
the warrants issued in the June and July 1997 private placement were exercised,
in exchange for which the Company issued 147,850 new 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.
<PAGE>
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 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 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 Vitajet Transaction and include the Common Stock
issued thereunder or upon exercise of the warrant issued to Raphael in February,
1998. The term "Selling Shareholder" includes all persons acquiring securities
in the Vitajet Transaction and the Raphael placement and persons acquiring such
securities in permitted transfers from the original holders thereof in
transactions not requiring registration under the Securities Act.
The following table sets forth certain information regarding the beneficial
ownership of shares of Common Stock by the Selling Shareholders as of September
4, 1998, and as adjusted to reflect the sale of the Shares.
Number of Shares Maximum Number of Shares Owned
Owned Shares to be Sold After Offering (1)
Name Prior to Offering under this Prospectus Number Percent
- ---- ----------------- --------------------- ------------------
Vitajet
Corporation 100,000 100,000 0 *
Raphael, L.L.C.(2) 100,000 100,000 0 *
Total 200,000 200,000 0
_________________
* Less than 1%.
(1) Assumes that the Selling Shareholders will sell all Shares during the
effective period.
(2) Includes (i) 80,000 shares of Common Stock issuable upon exercise of a
warrant.
<PAGE>
Although 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, Vitajet is owned by Sergio Landau, a Bioject
employee.
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 of 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. (As used herein, "Selling Shareholders"
includes donees and pledgees selling shares received from a named selling
shareholder after the date of this prospectus.) 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 Selling Shareholders may resell all or a portion of the shares in open
market transactions in reliance upon Rule 144 under the Securities Act, provided
they meet the criteria and conform to the requirements of such Rule.
The Company will not receive any of the proceeds from any sale of the Shares by
the Selling Shareholders offered hereby.
The Company has agreed to bear customary expenses incident to the registration
of the Shares for the benefit of the Selling Shareholders, 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 September 11, 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.
<PAGE>
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 contained in 200,000 Shares
this Prospectus in connection contained herein,
and, if given or made, such information or Common Stock
representations must not be relied upon as having (without par value)
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
Risk Factors 4
Use Of Proceeds 7
Selling Shareholders 7
Plan of Distribution 8
Legal Matters 9
Experts 9
________________
PROSPECTUS
________________
September 11, 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 $ 58.98
Blue Sky Fees and Expenses 0.00
Accounting Fees and Expenses 5,000.00
Legal Fees and Expenses 3,000.00
Miscellaneous 0.00
Total $ 8,058.98
_________________________
The Selling Shareholders will pay no portion of the foregoing expenses.
<PAGE>
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 Asset Purchase Agreement dated March 23, 1998. (Incorporated by
reference to exhibit number 10.53 of the Company's Form 10-K for the
year ended March 31, 1998.)
4.2 Stock Subscription Agreement dated March 30, 1998.
4.3 Form of Series J Purchase Warrant dated February 20, 1998.
(Incorporated by reference to exhibit number 10.49 of the Company's
Form 10-K for the year ended March 31, 1998.)
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
filed on September 4, 1998)
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.
<PAGE>
(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.
<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 Registration
Statement to be signed on its behalf by the undersigned, thereunto duly
authorized, in the City of Portland, State of Oregon, on September 11, 1998.
BIOJECT MEDICAL TECHNOLOGIES INC.
BY: /s/ James O'Shea
James C. O'Shea
Chairman, President and
Chief Executive 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/ James O'Shea Chairman of the Board, Chief
James C. O'Shea Executive Officer and President
(Principal Executive Officer) September 10, 1998
/s/Michael A. Temple Vice President, Chief Financial September 11, 1998
Michael A. Temple Officer and Secretary/Treasurer
(Principal Accounting and
Financial Officer)
/s/ * Director September 10, 1998
William A. Gouveia
/s/ * Director September 10, 1998
John Ruedy, M.D.
/s/ * Director September 10, 1998
Grace Keeney Fey
/s/ * Director September 10, 1998
Eric T. Herfindal
/s/ * Director September 10, 1998
David de Weese
/s/ * Director September 10, 1998
Richard J. Plestina
/s/ * Director September 10, 1998
Michael Sember
* By /s/ James O'Shea
/s/ James C. O'Shea
Attorney-in-fact
<PAGE>
INDEX TO EXHIBITS
Exhibit
Number Description
4.2 Stock Subscription Agreement dated March 30, 1998.
5.1 Opinion of Bogle & Gates P.L.L.C.
23.1 Consent of Bogle & Gates P.L.L.C. (included on Exhibit 5.1)
23.2 Consent of Arthur Andersen LLP
EXHIBIT 4.2
STOCK SUBSCRIPTION AGREEMENT
The undersigned corporation (the "Purchaser"), a corporation formed under the
laws of the State of California, hereby subscribes for the purchase of 100,000
shares of the common stock (the "Shares") of Bioject Medical Technologies Inc.,
an Oregon corporation (the "Corporation"), on the terms and conditions set forth
in that certain Asset Purchase Agreement dated March 23, 1998 (the "Asset
Purchase Agreement").
The Purchaser is aware that the Shares have not been registered under the
Securities Act of 1933, as amended (the "Securities Act"), or any state
securities laws, in reliance on exemptions from such registration. It is
understood that reliance by the Corporation on such exemptions is predicated in
part upon the truth and accuracy of the statements made by the Purchaser in this
Stock Subscription Agreement.
The undersigned hereby represents and warrants that the duly authorized
representatives of the Purchaser:
(i) has read and carefully considered the Corporation's periodic reports filed
with the Securities and Exchange Commission pursuant to Section 13 of the
Securities Exchange Act of 1934;
(ii) either alone or with the assistance of the Purchaser's professional
advisors, have such knowledge and experience in financial and business matters
that Purchaser is capable of evaluating the merits and risks of Purchaser's
purchase of the Shares;
(iii) the Purchaser has sufficient financial resources to be able to bear the
risk of the Purchaser's investment in the Shares; and
(iv) have either spoken or met with, or been given reasonable opportunity to
speak with or meet with, representatives of the Corporation for the purpose of
asking questions of, and receiving answers and information from, such
representatives concerning the Purchaser's investment in the Shares.
The undersigned hereby represents and warrants that the Purchaser is purchasing
the Shares for its own account for investment purposes and not with a present
view toward the sale or distribution of all or any part of the Shares. No one
other than the Purchaser has any beneficial interest in the Shares.
It is understood that, because the Shares have not been registered under the
Securities Act, (i) the Shares have the status of securities acquired in a
transaction under Section 4(2) of the Securities Act; and (ii) the Shares cannot
be sold unless the Shares are subsequently registered or an exemption from
registration is available.
The undersigned agrees that Purchaser will in no event sell or distribute all or
any part of the Shares unless (i) there is an effective registration statement
under the Securities Act and applicable state securities laws covering any such
transaction involving the Shares, or (ii) the Corporation receives an opinion of
the undersigned's legal counsel, in form acceptable to the Corporation, stating
that such transaction is exempt from registration, or (iii) the Corporation
otherwise satisfies itself that such transaction is exempt from registration.
The undersigned consents to (i) the placing of the legend set forth below on the
certificate representing the Shares stating that the Shares have not been
registered and setting forth the restriction on transfer contemplated hereby and
(ii) the placing of a stop transfer order on the books of the Corporation and
with any transfer agents against the Shares.
<PAGE>
The following legend shall be placed on certificates representing the Shares:
"THE SECURITIES REPRESENTED HEREBY HAVE NOT BEEN REGISTERED UNDER UNITED STATED
FEDERAL OR STATE SECURITIES LAWS AND MAY NOT BE OFFERED FOR SALE, SOLD OR
OTHERWISE TRANSFERRED OR ASSIGNED FOR VALUE, DIRECTLY OR INDIRECTLY, NOR MAY THE
SECURITIES BE TRANSFERRED ON THE BOOKS OF THE CORPORATION, WITHOUT REGISTRATION
OF SUCH SECURITIES UNDER ALL APPLICABLE UNITED STATES FEDERAL OR STATE
SECURITIES LAWS OR COMPLIANCE WITH AN APPLICABLE EXEMPTION THEREFROM, SUCH
COMPLIANCE, AT THE OPTION OF THE CORPORATION, TO BE EVIDENCED BY AN OPINION OF
SHAREHOLDER'S COUNSEL, IN FORM ACCEPTABLE TO THE CORPORATION, THAT NO VIOLATION
OF SUCH REGISTRATION PROVISIONS WOULD RESULT FROM ANY PROPOSED TRANSFER OR
ASSIGNMENT."
The parties acknowledge that the Asset Purchase Agreement contains a provision
relating to the registration of the Shares, which is not affected by this Stock
Subscription Agreement. It is understood that except to the extent expressly set
forth in the Asset Purchase Agreement, the Corporation has no other obligation
to the Purchaser to register the Shares under the Securities Act and has not
otherwise represented to the undersigned that it will register the Shares.
THE UNDERSIGNED HAS CAREFULLY READ THE FOREGOING AND UNDERSTANDS THAT IT RELATES
TO RESTRICTIONS UPON THE PURCHASER'S ABILITY TO SELL AND/OR TRANSFER ITS
SECURITIES.
Dated: March 23, 1998
Vitajet Corporation
/s/ Sergio Landau
By: Sergio Landau
Its: President
Address: 27071 Cabot Road, Suite 110
Laguna Hills, CA 92653
ACCEPTANCE
The foregoing Stock Subscription Agreement and the consideration reflected
therein are hereby accepted.
Dated: March 23, 1998
Bioject Medical Technologies Inc.
/s/ James O'Shea
By: James O'Shea
Its: Chairman, President and
Chief Executive officer
Exhibit 5.1
[Letterhead of Bogle & Gates P.L.L.C.]
September 11, 1998
Bioject Medical Technologies Inc.
7620 SW Bridgeport Road
Portland, Oregon 97224
Gentlemen and Ladies:
We are delivering this opinion in connection with the Registration
Statement on Form S-3/A (the "Registration Statement") of Bioject Medical
Technologies Inc. (the "Company") to be filed with the Securities and Exchange
Commission under the Securities Act of 1933, as amended (the "Securities Act"),
with respect to an aggregate of 200,000 shares, without par value, of common
stock of the Company (the "Shares") to be resold by certain selling shareholders
named therein (the "Selling Shareholders").
We have examined and are familiar with originals or copies, certified or
otherwise identified to our satisfaction, of such documents, corporate records
and other instruments relating to the incorporation of the Company and to the
authorization and issuance of the Shares, and have made such investigations of
law, as we have deemed necessary and advisable.
Based upon the foregoing and having due regard for such legal questions as
we have deemed relevant, we are of the opinion that:
The 120,000 Shares, which were purchased by The Selling Shareholders, have
been duly authorized, and, when issued, constituted or will constitute
duly authorized, legally issued, fully paid and nonaccessable shares of
common stock of the Company.
The 80,000 Shares, which will be issued to the Selling Shareholders upon
the exercise of warrants, have been duly authorized, and, upon issuance and
receipt of payment therefore in accordance with the terms of the warrants,
will constitute duly authorized, legally issued, fully paid and
nonassessable shares of common stock of the Company.
We hereby consent to the filing of this opinion as an exhibit to the
Registration Statement referred to above, and to the reference to our firm in
the Prospectus constituting a part of the Registration Statement.
Very truly yours,
/s/BOGLE & GATES P.L.L.C.
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/A Registration Statement (Amendment No. 1) of our
report dated April 30, 1998 included in the Bioject Medical Technologies, Inc.
Annual Report on Form 10-K/A for the fiscal year ended March 31, 1998 and to all
references to our firm included in this Registration Statement
/s/ Arthur Andersen, LLP
Portland, Oregon
September 11, 1998
