-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, GF9IrOJa5EZQU80gKZv2lOYgKiDlhaQOQqjex6yUVxp6zHJzvo3POAR1L7EGBBPp dcEAy4EmVl8WRNQgkd3byQ== 0001104659-04-008314.txt : 20040324 0001104659-04-008314.hdr.sgml : 20040324 20040324135416 ACCESSION NUMBER: 0001104659-04-008314 CONFORMED SUBMISSION TYPE: 10-K PUBLIC DOCUMENT COUNT: 10 CONFORMED PERIOD OF REPORT: 20031231 FILED AS OF DATE: 20040324 FILER: COMPANY DATA: COMPANY CONFORMED NAME: BIOJECT MEDICAL TECHNOLOGIES INC CENTRAL INDEX KEY: 0000810084 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 931099680 STATE OF INCORPORATION: OR FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-15360 FILM NUMBER: 04686878 BUSINESS ADDRESS: STREET 1: 7620 S W BRIDGEPORT RD CITY: PORTLAND STATE: OR ZIP: 97224 BUSINESS PHONE: 5036397221 MAIL ADDRESS: STREET 1: 7620 S W BRIDGEPORT ROAD CITY: PORTLAND STATE: OR ZIP: 97224 FORMER COMPANY: FORMER CONFORMED NAME: BIOJECT MEDICAL SYSTEMS LTD DATE OF NAME CHANGE: 19920703 10-K 1 a04-1725_110k.htm 10-K

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D. C. 20549

 

FORM 10-K

 


 

ý           ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

For the Fiscal Year Ended: December 31, 2003

 

OR

 

o           TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

 

Commission File Number: 0-15360

 

BIOJECT MEDICAL TECHNOLOGIES INC.

(Exact name of registrant as specified in its charter)

 

Oregon

 

93-1099680

(State or other jurisdiction of incorporation or organization)

 

(I.R.S. Employer Identification No.)

 

 

 

211 Somerville Road (Route 202 North)
Bedminster, New Jersey

 

07921

(Address of principal executive offices)

 

(Zip Code)

 

 

 

Registrant’s telephone number, including area code:  (908) 470-2800

 

Securities registered pursuant to Section 12(b) of the Act: None

Securities registered pursuant to Section 12(g) of the Act: Common Stock, without par value

 


 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days: Yes ý     No o

 

Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K, or any amendment to this Form 10-K.   o

 

Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Act):

Yes o    No ý

 

The aggregate market value of the voting and non-voting common equity held by non-affiliates of the registrant was $36,166,104, computed by reference to the last sales price ($4.00) as reported by the Nasdaq SmallCap System, as of the last business day of the Registrant’s most recently completed second fiscal quarter (June 30, 2003).

 

The number of shares outstanding of the registrant’s common stock as of February 23, 2004 was 13,530,137 shares.

 

Documents Incorporated by Reference

Portions of the registrant’s definitive Proxy Statement for the 2004 Annual Shareholders’ Meeting are incorporated by reference into Part III.

 

 



 

BIOJECT MEDICAL TECHNOLOGIES INC.

2003 FORM 10-K ANNUAL REPORT

TABLE OF CONTENTS

 

PART I

 

 

 

Item 1.

Business

 

 

 

 

Item 2.

Properties

 

 

 

 

Item 3.

Legal Proceedings

 

 

 

 

Item 4.

Submission of Matters to a Vote of Security Holders

 

 

 

 

PART II

 

 

 

Item 5.

Market for Registrant’s Common Equity and Related Stockholder Matters

 

 

 

 

Item 6.

Selected Consolidated Financial Data

 

 

 

 

Item 7.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

 

 

 

Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

 

 

 

 

Item 8.

Consolidated Financial Statements and Supplementary Data

 

 

 

 

Item 9.

Changes in and Disagreements With Accountants on Accounting and Financial Disclosure

 

 

 

 

Item 9A.

Controls and Procedures

 

 

 

 

PART III

 

 

 

Item 10.

Directors and Executive Officers of the Registrant

 

 

 

 

Item 11.

Executive Compensation

 

 

 

 

Item 12.

Security Ownership of Certain Beneficial Owners and Management

 

 

 

 

Item 13.

Certain Relationships and Related Transactions

 

 

 

 

Item 14.

Principal Accountant Fees and Services

 

 

 

 

PART IV

 

 

 

Item 15.

Exhibits, Financial Statement Schedules and Reports on Form 8-K

 

 

 

 

Signatures

 

 

1



 

PART I

 

ITEM 1.   BUSINESS

 

General

We commenced operations in 1985.  We develop needle-free injection systems that improve the way patients take medications and vaccines.

 

Our long-term goal is to become the leading supplier of needle-free injection systems to the pharmaceutical and biotech industries.  In 2003, we continued to focus our business development efforts on new and existing licensing and supply agreements with leading pharmaceutical and biotechnology companies. By bundling customized needle-free delivery systems with partners’ injectable medications and vaccines, we can enhance demand for these products in the healthcare provider and end user markets.

 

In 2004, our clinical research efforts will continue to be aimed primarily at clinical research collaborations in the areas of vaccines and drug delivery. Currently, we are involved in collaborations with 22 institutions.

 

In 2004, our other research and development efforts will focus on moving our 0.5 mL and our 1.0 mL Iject® from the clinical phase to the production phase, which includes bringing on line our sterile fill capabilities. In addition, we continue to work on product improvements to existing devices and development of products for our strategic partners.

 

Our needle-free injection technology works by forcing liquid medication at high speed through a tiny orifice held against the skin. This creates a fine stream of high-pressure medication that penetrates the skin, depositing the medication in the tissue beneath.

 

Since our formation, we have been engaged principally in organizational, financing, research and development, and marketing activities. Our 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 is regulated by the Food and Drug Administration  (“FDA”) under section 510(k) of the Federal Food, Drug, and Cosmetic Act (“FFDCA”).

 

We are actively pursuing strategic partnering relationships with a number of pharmaceutical and biotechnology companies under which we plan to grant specified rights or licenses to some or all of our products. The strategy anticipates that the rights or licenses will allow strategic partners to i) use the licensed products for specific applications or purposes or ii) market the licensed products in conjunction with certain of their products.

 

Currently, we have three strategic partners for our needle-free injection systems: Ares-Serono, Alkermes and Merial.

 

Ares Serono.  Ares-Serono Group, plc. (“Serono”) licensed our Vitajet® 3 (Vitajet®) injection system for delivery of its human growth hormone. The Vitajet® has been customized for use in the pediatric growth hormone market for Serono’s Saizen® product, is marketed as the cool.click™ and has FDA clearance.  The SeroJet™, a customized version of the Vitajet®, has been cleared by the FDA for use with Serostim® for the treatment of AIDS wasting.

 

Alkermes.  We have a license and development agreement with Alkermes, Inc., a leader in the development of pharmaceutical products based on advanced drug delivery systems, to develop up to three undisclosed drug compounds as proprietary products using the Iject® needle-free drug delivery system.   In 2003, development efforts and activity associated with this agreement were minimal.

 

2



 

Merial.   We have an exclusive license and supply agreement with Merial, the world’s leading animal health company, for delivery of Merial’s veterinary pharmaceuticals and vaccines utilizing a veterinary focused needle-free injector system the Vetjet™, which is currently in development.  Merial will initially focus on delivery of vaccines to food-production animals.

 

We are actively pursuing additional strategic partnering relationships with a number of other pharmaceutical and biotechnology companies.

 

We currently sell needle-free vial adapters used in the drug reconstitution process for lyophilized drugs to Amgen and Berlex. In addition to the above agreements, we sell our needle-free injection system, the Biojector® 2000, or B-2000, directly to healthcare professionals, which allows clinicians to inject medications through the skin, both intramuscularly and subcutaneously, without a needle.  Currently, our Biojector® 2000 is being utilized by the National Institutes of Health in human trials of vaccines for HIV and the Ebola virus.

 

We also directly market the Vitajet®, a spring-powered, needle-free, self-injection device, which has regulatory clearance for administering injections of insulin, to the home user.

 

Following is a chronology of significant milestones achieved:

 

Date

 

Milestone

April 1987

 

Received FDA clearance to market a hand-held CO2-powered needle-free injection system.

February 1993

 

Began U.S. distribution of our Biojector® 2000 system to hospitals and large clinics.

June 1994

 

Received FDA clearance to market a version of our Biojector® 2000 system in a configuration targeted at high volume injection applications.

October 1996

 

Received FDA clearance for a needle-free disposable vial access device.

March 1997

 

Received FDA clearance for certain enhancements to our Biojector® 2000 system.

September 1997

 

Entered into a joint venture agreement with Elan for the development and commercialization of certain blood glucose monitoring technology, which the Company licensed from Elan.

March 1998

 

Entered into a transaction with Vitajet Corporation whereby we acquired, along with certain other assets, the rights to the Vitajet®, a spring-powered, needle-free self-injection device, with FDA clearance for administering injections of insulin.

January 1999

 

Received ISO9001 and EN46001 certification.

June 1999

 

Marathon, the joint venture formed with Elan, completed the sale of its  license to the blood glucose monitoring technology and certain fixed assets related to the development of that technology.

November 1999

 

Received CE Mark certification for our jet injection systems, which allows the products to be sold in the European Union.

December 1999

 

Entered into a license and distribution agreement with Ares-Serono to deliver human growth hormone with a modified Vitajet®  for the pediatric growth market.

February 2000

 

Entered into a clinical development and supply agreement with Amgen for the Iject®, a single use disposable jet injector.

June 2000

 

Received FDA clearance for a modified version of the Vitajet®, called the cool.click™, to administer injections of Serono’s human growth hormone Saizen®.

October 2000

 

Amended Serono’s license and distribution agreement to include exclusive worldwide rights for the cool.click™ injection device to deliver Saizen® and to include worldwide rights to deliver Serostim® for AIDS wasting applications  with a modified Vitajet®, called the SeroJet™.

March 2001

 

Received FDA clearance for a modified version of our Vitajet®, called the SeroJet™, to administer injections of Serono’s human growth hormone Serostim® for the treatment of AIDS wasting.

April 2001

 

Received FDA clearance to market a Reconstitution Kit and Vial Connector.

October 2001

 

Entered into a license and development agreement with Alkermes  for the use of our Iject®, single-use disposable jet injector.

October 2001

 

National Institutes of Health uses our Biojector® 2000 system in testing of first AIDS vaccine.

 

3



 

January 2002

 

Entered into an agreement with Memorial Sloan-Kettering for the use of our Biojector® 2000 system  in DNA vaccine research.

August 2002

 

Entered into a license and supply agreement with Merial for delivery of their veterinary pharmaceuticals and vaccines utilizing a veterinary focused needle-free injector system, the Vetjet™.

March 2003

 

Signed Supply Agreement with Amgen for Needle-Free Vial Adapter Product

June 2003

 

Signed a services and supply subcontract with SAIC-Frederick, Inc., a subsidiary of Science Applications International Corporation – Frederick (SAIC). Under SAIC’s contract with the National Cancer Institute, the federal government will utilize our Biojector® 2000 needle-free technology in HIV and Ebola clinical trials.

December 2003

 

Completed a Phase I clinical study comparing our Iject® pre-filled, needle-free drug delivery system to the traditional needle-and-syringe.  The results of the study indicated that the Iject® device was less painful and easier to use than needle and syringe and preferred by volunteers.

 

“Biojector,” “Bioject,” “Vitajet,” “Iject,” “Iject-R,” “Vetjet” and “Medivax” are trademarks or registered trademarks of Bioject Medical Technologies Inc.

 

Where You Can Find More Information

 

We file annual, quarterly and special reports, proxy statements and other information with the Securities and Exchange Commission (“SEC”) under the Securities Exchange Act of 1934 as amended (the “Exchange Act”). You can inspect and copy our reports, proxy statements, and other information filed with the SEC at the SEC’s Public Reference Room in Washington, D.C. Please call the SEC at 1-800-SEC-0330 for further information on the Public Reference Room. The SEC maintains an Internet Web site at http://www.sec.gov/ where you can obtain some of our SEC filings. In addition, you can inspect our reports, proxy materials and other information at the offices of the Nasdaq Stock Market at 1735 K Street NW, Washington D.C. 20006. We also make available free of charge on our website at www.bioject.com our annual report on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act as soon as reasonably practicable after they are filed electronically with the SEC.  You can also obtain copies of these reports by contacting Investor Relations at 908-470-2800 x 5103.

 

Needle-free Injection

 

Medications are currently delivered using various methods, each of which has both advantages and limitations. The most commonly used drug delivery techniques include oral ingestion, intravenous infusion, subcutaneous, intradermal and intramuscular injection, inhalation and transdermal “patch” diffusion.  Many drugs are effective only when injected.  Published data indicates that more than 1.7 billion needle-syringes are sold annually in the U.S.  We believe that approximately 80% of these syringes are used for subcutaneous or intramuscular injections up to 1.0 mL.

 

Injections using traditional needle-syringes suffer from many shortcomings, including: (i) the risk of needlestick injuries; (ii) the risk of penetrating a patient’s vein; and (iii) the patient’s aversion to needles and discomfort.  The most dangerous of these, the contaminated needlestick injury, occurs when a needle that has been exposed to a patient’s blood accidentally penetrates a healthcare worker’s skin.  Contaminated needles can transmit deadly blood-borne pathogens including such viruses as HIV and Hepatitis B.  Published data estimate that approximately 800,000 needlestick injuries occur in the U.S. each year.

 

Because of growing awareness in recent years of the danger of blood-borne pathogen transmission, needle safety has become a higher concern for hospitals, healthcare professionals and their patients.  As a result, pressure on the healthcare industry to eliminate the risk of contaminated needlestick  injuries has increased. For example, the U.S. Occupational Safety and Health Administration (“OSHA”) issued regulations, effective in 1992, which require healthcare institutions to treat all blood and other body fluids as infectious.  These regulations were changed by Congress with passage of the

 

4



 

Needlestick Safety Prevention Act, which was effective in 2001. These regulations require implementing  “engineering and work practice controls” to “isolate or remove blood-borne pathogen hazards from the workplace.” Among the required controls are special handling and disposal of contaminated “sharps” in biohazardous “sharps” containers, safer medical devices, including needleless systems, and follow-up testing for victims of needlestick injuries.  To date, 27 states and the U.S. Occupational Safety and Health Administration have adopted, or have pending, legislation or regulations that require health care providers to utilize systems designed to reduce the risk of needlestick injuries.

 

The costs resulting from needlestick injuries vary widely. Accidental needlesticks involving sterile needles involve relatively little cost. Needlesticks with contaminated needles require investigation and follow-up. These are much more expensive. Investigation typically includes identifying the source of contamination, testing the source for blood-borne pathogens and repeatedly testing the needlestick victim for infection over an extended period. Some healthcare providers are requiring additional measures, including treating all needlestick injuries as contaminated unless proven otherwise.

 

In an effort to protect healthcare workers from needlestick injuries, many healthcare facilities have adopted more expensive, alternative technologies. While these technologies can help to reduce accidental needlesticks, they cannot eliminate the risk.

 

Description of Our Products

 

Biojector® 2000

Our Biojector® 2000 system (B-2000) consists of two components: a hand-held, reusable jet injector; and a sterile, single-use, disposable plastic syringe capable of delivering variable doses of medication up to 1.0 mL. The B-2000 system is a refinement of jet injection technology that enables healthcare professionals to reliably deliver measured variable doses of medication through the skin, either intramuscularly or subcutaneously, without a needle.

 

The first component of the system, the Biojector® 2000, is a portable hand-held device, which is approximately the size of a flashlight.  It is designed both for ease of use by healthcare professionals, as well as to be attractive and non-threatening to patients. The Biojector® 2000 injector uses disposable CO2 cartridges as a power source.  The CO2 cartridges, which are purchased from an outside supplier, give an average of ten injections before requiring replacement. The CO2 gas provides consistent, reliable pressure on the plunger of the disposable syringe, thereby propelling the medication into the tissue.  The CO2  propellant does not come into contact with either the patient or the medication. The B-2000 is also available with a tank adapter which allows the device to be attached to a large volume CO2 tank. The tank adapter eliminates the need to change CO2 cartridges after every ten injections and is an attractive option for applications where a large number of injections are given in a relatively short period of time.

 

The second component of the system, the Biojector® single-use disposable syringe, is provided in a sterile, peel-open package and consists of a plastic, needle-free, variable dose syringe, Drug Reconstitution System (“DRS” or “Vial Adapter”) needle-free syringe filling device, which is used to fill the syringe, and a safety cap.  If requested by a customer, the product can also be supplied with a needle which is used as an alternative to the Vial Adapter for filling the syringe.  The body of the syringe is transparent and has graduated markings to aid accurate filling by healthcare workers.

 

There are five different Biojector® syringes, each of which is intended for a different injection depth or body type. The syringes are molded using our patented manufacturing process.  A trained healthcare worker selects the syringe appropriate for the intended type of injection.  One syringe size is for subcutaneous injections, while the others are designed for intramuscular injections, depending on the patient’s body characteristics and the location of the injection.

 

5



 

Giving an injection with a Biojector® 2000 system is easy and straightforward. The healthcare worker giving the injection checks the CO2 pressure on an easy-to-read gauge at the rear of the injector, draws medication up into a disposable plastic syringe using either a needle or the needle-free Vial Adapter, inserts the syringe into the Biojector® 2000, presses the syringe tip against the appropriate disinfected surface on the patient’s skin, and then presses an actuator, thereby injecting the medication.  A thin stream of medication is expelled at high velocity through a precision molded, small diameter orifice in the syringe. The medication is injected at a velocity sufficient to penetrate the skin and force the medication into the tissue at the desired depth.

 

The current suggested retail list price for the Biojector® 2000 professional jet injector is $1,200, and the suggested retail list price for Biojector® syringes is $125 for a box of 100 syringes.  CO2 cartridges are sold for a suggested retail price of $6.00 for a box of ten.  Discounts are offered for volume purchases.

 

Drug Reconstitution System

The needle-free drug reconstitution system allows for the transfer of diluents to reconstitute powdered medications into liquid form and withdrawal of liquid medication into a syringe without the use of a needle.  Bioject’s 13mm Vial Adapter has a compact, polycarbonate spike design to draw up liquid medication and to reconstitute lyophilized (powdered) medication.  It allows healthcare workers and patients to access medication without using a needle.  The Vial Adapter fits most single and multi-dose medication vials available in the US and European markets, and is widely used in clinics and home healthcare throughout North America.  While the Vial Adapter is an integral part of the needle-free syringe packaging for the Biojector 2000 needle-free injection system, it functions perfectly with any conventional syringe.

 

Several pharmaceutical manufacturers include this unique product as part of their drug reconstitution kits. The 13mm Vial Adapter is the ideal solution to the challenges of reconstituting and drawing up medication.  It provides clinicians and patients the highest levels of safety, convenience and ease of use.

 

The suggested retail price for the Vial Adapter is $90.00 for a box of 300. Discounts are offered for volume purchases.

 

Vitajet®

The Vitajet® is also composed of two components, a portable injector unit and a disposable syringe.  It is smaller and lower in cost than other products in our  needle-free offering.  The method of operation and drug delivery is similar to the Biojector®, except that the Vitajet® is powered by a spring rather than by CO2.  Due to its ease of use and lower cost, it is a good solution for home-use self-injection.  Vitajet’s® regulatory labeling limits its use to the injection of Insulin.  A modified Vitajet®, called the cool.click™, has received regulatory clearance for injection of Serono’s human growth hormone Saizen® and another modified Vitajet®, called the SeroJet™, has regulatory clearance for administering the Serono human growth hormone Serostim® for the treatment of AIDS Wasting. We believe that the Vitajet® has the potential to achieve regulatory labeling for additional subcutaneous injections.

 

The current suggested retail price for the Vitajet® needle-free injector is $250.  A three month supply (13-count) of Vitajet® syringes is sold for a suggested retail price of $60.

 

We have other products under development, which are intended to address other markets or to enhance the Biojector® 2000 system.  See “Research and Product Development.”

 

6



 

Marketing and Competition

The traditional needle-syringe is currently the primary method for administering intramuscular and subcutaneous injections.

 

During the last 20 years, there have been many attempts to develop portable one-shot jet injection hypodermic devices. Problems have arisen in the attempts to develop such devices including: (i) inadequate injection power; (ii) little or no control of pressure and depth of penetration; (iii) complexity of design, with related difficulties in cost and performance; (iv) difficulties in use, including filling and cleaning; and (v) the necessity for sterilization between uses.

 

In recent years, several spring-driven, needle-free injectors have been developed and marketed, primarily for injecting Insulin. Current list prices for such injectors range from approximately $190  to $600 per injector.  We believe that market acceptance of these devices has been limited due to a combination of the cost of the devices coupled with the difficulties of their use.

 

Also in recent years, various versions of a “safety syringe” have been designed and marketed.  Most versions of the safety syringe generally involve a standard or modified needle-syringe with a plastic guard or sheath surrounding the needle. Such covering is usually retracted or removed in order to give an injection. The intent of the safety syringe is to reduce or eliminate needlestick injuries.  However, while the safety syringe is in use and before the needle has been covered, a safety syringe still poses a risk of needlestick injury.  Additionally, some safety syringes require manipulation after injection and pose the risk of needlestick injury during that manipulation. Safety syringes are also often bulky and add to contaminated waste disposal costs.

 

Our primary sales and marketing objective is to form licensing and supply arrangements with leading pharmaceutical, biotechnology and veterinary companies, which would ordinarily include some or all of the following components: i) licensing revenues for full or partially exclusive access to our products for a specific application or medical indication; ii) development fees if we customize one of our products for the customer or develop a new product; iii) milestone  payments related to the customer’s progress in developing products to be used in conjunction with our products; iv) royalty revenue derived from strategic partners’ drug sales; and v) product revenues from the sale of our products to the customer pursuant to a supply agreement.  Product sales through this channel would ordinarily be made to the pharmaceutical or biotechnology company, whose sales force would then sell that company’s injectable pharmaceutical products, along with our products, to end-users. We have one Vice President and one Director of Business Development whose primary focus is to identify companies and drugs that fit our targeted profile.

 

We intend to focus the direct sales efforts of our needle-free injection systems on the military and public health markets. To implement our direct sales and marketing efforts, we currently employ a national sales manager, one strategic accounts manager, one customer service representative, and three part-time nurse trainers. Our direct sales efforts have resulted in the signing of supply agreements with the state of Alaska, the Departments of Public Health of New York City and the District of Columbia, and the County of San Francisco. We have also secured a 5-year supply contract through the Veterans Administration authorizing direct sales to all branches of the U.S. Department of Defense, U.S. Public Health Service and the Federal Bureau of Prisons.  Finally, we renewed and expanded annual supply agreements for the needle-free Vial Adapter with several pharmaceutical manufacturers.

 

Selling to new customers in our target markets is often a lengthy process.  A new customer is typically adopting our products as a new technology. Accordingly, the purchase approval process usually involves a lengthy product evaluation process, including testing and approval by several individuals or committees within the potential customer’s organization and a thorough cost-benefit analysis.

 

7



 

The medical equipment market is highly competitive, and competition is likely to intensify.  Many of our existing and potential competitors have been in business longer than us and have substantially greater technical, financial, marketing, sales and customer support resources. We believe that the primary competition for the Biojector® 2000 system, and other needle-free jet injection systems we may develop, is the traditional, disposable needle-syringe and the safety syringe.  Leading suppliers of needle-syringes include: Becton-Dickinson & Co., Sherwood Medical Co., a subsidiary of American Home Products Corp., and Terumo Corp. of Japan. Manufacturers of traditional needle-syringes compete primarily on price, which generally ranges from approximately $0.08 to $0.22 per unit.  Manufacturers of safety syringes compete on features, quality and price. Safety syringes generally are priced in a range of $0.20 to $1.00 per unit.  The average price per injection with the B-2000 is approximately $0.66 to $1.25.

 

We expect to compete with traditional needle-syringes and safety syringes based on issues of healthcare worker safety, ease of use, reduced cost of disposal, patient comfort, and reduced cost of compliance with OSHA regulations and other legislation.  Except in the case of certain safety syringes, we do not expect to compete with needle-syringes based on purchase cost alone. However, we believe that the B-2000 system will compete effectively based on overall cost when all indirect costs, including disposal of syringes and testing, treatment and workers’ compensation expenses related to needlestick injuries, are considered.

 

We believe Bioject is the only company who has a product like the B-2000 product cleared by the U.S. Food and Drug Administration to give both subcutaneous and intramuscular injections up to 1.0 mL. Several companies are developing devices that will likely compete with our jet injection products for certain applications, but to date, none have obtained U.S. marketing regulatory clearance for both subcutaneous and intramuscular indications.

 

We are aware of other portable, needle-free injectors currently on the market, which are generally focused on subcutaneous self-injection applications of 0.5 mL. or less.  These compete primarily with the Vitajet®.  Also, we are not aware of any current competing products with U.S. regulatory approval that have the total features and benefits comparable to the B-2000 system. The Biojector® is suitable for both intramuscular and subcutaneous injections of up to 1 mL. in the professional and home injection markets.  Manufacturers of needle-syringes, as well as other companies, may develop new products that compete directly or indirectly with our products.  There can be no assurance that we will be able to compete successfully in this market.  A variety of new technologies (for example, transdermal patches) are being developed as alternatives to injection for drug delivery. While we do not believe such technologies have significantly affected the use of injection for drug delivery to date, there can be no assurance that they will not do so in the future.

 

Significant Customers

In the year ended December 31, 2003, two customers, Amgen and Serono, accounted for approximately 32% and 29% of total revenues, respectively.

 

Patents and Proprietary Rights

We believe that the technology incorporated in our currently marketed Biojector® 2000  and Vitajet® devices and single-dose disposable plastic syringes, as well as the technology of products under development, give us significant advantages over both the manufacturers of competing needle-free jet injection systems and over prospective competitors seeking to develop similar systems. We attempt to protect our technology through a combination of patents, trade secrets and confidentiality agreements and practices.

 

Patent Summary Table

 

Item

 

Issued

 

Pending

 

Total

 

U.S.A. Patents

 

33

 

15

 

48

 

Foreign Patents

 

9

 

21

 

30

 

Total

 

42

 

36

 

78

 

 

Trademark Summary Table

 

Item

 

Issued

 

Pending

 

Total

 

U.S.A. Trademarks

 

4

 

1

 

5

 

Foreign Trademarks

 

5

 

2

 

7

 

Total

 

9

 

3

 

12

 

 

8



 

Patent applications have been filed on matters specifically related to single use, disposable devices currently under development.  We generally file patent applications in the U.S., Canada, Europe and Japan at the times and under the circumstances that we deem filing to be appropriate in each of those jurisdictions. There can be no assurance that any patents applied for will be granted or that patents held by us will be valid or sufficiently broad to protect our technology or provide a significant competitive advantage.  We also rely on trade secrets and proprietary know-how that we seek to protect through confidentiality agreements with our employees, consultants, suppliers and others. There can be no assurance that these agreements will not be breached, that we would have adequate remedies for any breach, or that our trade secrets will not otherwise become known to, or be developed independently by, competitors.  In addition, the laws of foreign countries may not protect our proprietary rights to our technology, including patent rights, to the same extent as the laws of the U.S.

 

We believe that we have independently developed our technology and attempt to assure that our products do not infringe on the proprietary rights of others.  However, if infringement of the proprietary rights of others is alleged and proved, there can be no assurance that we could obtain necessary licenses to that technology on terms and conditions that would not have an adverse effect.  We are not aware of any asserted claim that the Biojector® 2000, the Vitajet® or any product under development violates the proprietary rights of any third party.

 

If a dispute arises concerning our technology, we could become involved in litigation that might involve substantial cost. Such litigation might also divert substantial management attention away from our operations and into efforts to enforce our patents, protect our trade secrets or know-how or determine the scope of the proprietary rights of others.  If a proceeding resulted in adverse findings, we could be subject to significant liabilities to third parties.  We might also be required to seek licenses from third parties in order to manufacture or sell our products.  Our ability to manufacture and sell our products might also be adversely affected by other unforeseen factors relating to the proceeding or its outcome.

 

Government Regulation

Our products and manufacturing operations are subject to extensive government regulations, both in the U.S. and abroad. In the U.S., the FDA administers the Federal Food, Drug and Cosmetic Act (FFDCA) and has adopted regulations to administer that Act. These regulations include policies that: i) govern the introduction of new medical devices; ii) require observing certain standards and practices in the manufacture and labeling of medical devices; and iii) require medical device companies to maintain certain records and report device-related deaths, serious injuries and certain malfunctions to the FDA. Our manufacturing facilities and certain of our records are also subject to FDA inspection. The FDA has broad discretion to enforce the FFDCA and related regulations. Noncompliance with the Act or its regulations can result in a variety of regulatory actions including warning letters, product detentions, device alerts or field corrections, voluntary and mandatory recalls, seizures, injunctive actions and civil or criminal penalties.

 

Unless exempted by regulation, the FFDCA provides that medical devices may not be commercially distributed in the U.S. unless they have been cleared by the FDA. The FFDCA provides two basic review procedures for pre-market clearance of medical devices. Certain products qualify for a submission authorized by Section 510(k) of the FFDCA.  Under Section 510(k), manufacturers provide the FDA with a pre-market notification (“510(k) notification”) of the manufacturer’s intent to begin marketing the product. In the 510(k) notification, the manufacturer must establish, among other things, that the product it plans to market is substantially equivalent to another legally marketed product. To be substantially equivalent, a proposed product must have the same intended use and be determined to be as safe and effective as a legally marketed device. Further, it may not raise questions of safety and effectiveness that are different from those associated with a legally marketed device. Marketing a medical device may commence when the FDA issues correspondence finding substantial equivalence to such a legally marketed device. The FDA may require, in connection with the 510(k) submission that it be provided with animal and/or human clinical test results.

 

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If a medical device does not qualify for the 510(k) procedure, the manufacturer must file a pre-market approval application (“PMA”).  A PMA must show that the device is safe and effective and is generally a much more comprehensive submission than a 510(k) notification.  A PMA typically requires more extensive testing before filing with the FDA and a longer FDA review process.

 

A 510(k) notification is required when a device is being introduced into the market for the first time, when the manufacturer makes a change or modification to an already marketed device that could significantly affect the device’s safety or effectiveness, and when there is a major change or modification in the intended use of the device.  When any change or modification is made in a device or its intended use, the manufacturer is expected to make the initial determination as to whether the change or modification is of a kind that would require filing a new 510(k) notification.  FDA regulations provide only limited guidance in making this determination.

 

We are developing the Iject® Needle-Free Injection System, a single or multi-use prefilled disposable injector for self injection, and pre-filled Biojector® syringes.  We plan to seek arrangements with pharmaceutical and biotechnology companies to package their medications in pre-filled Biojector® syringes. See “Research and Product Development.” Before pre-filled Iject® or Biojector® syringe Systems may be distributed for use in the U.S., the FDA may require tests to prove that the medication will retain its chemical and pharmacological properties when stored in the pre-filled syringe.  It is current FDA policy that such pre-filled syringes are evaluated by the FDA by submitting a Request for Designation (RFD) to the Office of Combination Products, OCP. A prefilled syringe complies with FDA’s definition of a combination product, or a product comprised of two or more regulated components, i.e. drug/device. The office of Combination Products will assign a center with primary jurisdiction for a combination product (CDER, CDRH) and ensure the timely and effective premarket review. The primary or lead review Center often will consult or collaborate with other evaluation Centers to obtain all the appropriate materials and requirements to process the submission.

 

We believe that if a drug intended to be used in one of our pre-filled syringes was already the subject of an approved NDA or an ANDA for intramuscular or subcutaneous injection, then the main issues affecting clearance for use in the pre-filled syringe would be: i) the ability of the syringe to store the drug; ii) the ability of the manufacturer to assure the drug’s stability until used; and iii) the ability to demonstrate that the syringe will safely deliver the proper dose at the proper site.  FDA recommends pre-submission discussions with the OCP to clarify submission requirements. An early Request for Designation can avoid costly delays as the primary requirements and the premarket route (510(k), PMA, NDA) will be determined.

 

The FDA also regulates and monitors our quality assurance and manufacturing practices. The FDA requires us and our contract manufacturers to demonstrate compliance with current Good Manufacturing Practices (“GMP”) Regulations. These regulations require, among other things, that: i) the manufacturing process be regulated and controlled by the use of written procedures; and ii) the ability to produce devices which meet the manufacturer’s specifications be validated by extensive and detailed testing of every aspect of the process.  GMPs also require investigating any deficiencies in the manufacturing process or in the products produced and detailed record-keeping.  The FDA’s interpretation and enforcement of these requirements has been increasingly strict and will likely continue to be at least as strict in the future.  Failure to adhere to GMP requirements would cause the products produced by us to be considered in violation of the FFDCA and subject to enforcement action.  The FDA monitors compliance with these requirements by requiring manufacturers to register their establishments with the FDA, and by subjecting their manufacturing facilities to periodic FDA inspections. If the inspector observes conditions that violate the “Act” or GMP regulations, the manufacturer must correct those conditions or explain them satisfactorily. Otherwise, the manufacturer may face potential regulatory action, which may include warning letters, product detentions, device alerts or field corrections, voluntary and mandatory recalls, seizures, injunctive actions and civil or criminal penalties.

 

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Our manufacturing facility was last inspected by the FDA for compliance with Good Manufacturing Practices in July 2002, with no observations or official actions.

 

The FDA’s Medical Device Reporting Regulation requires that we provide information to the FDA if any death or serious injury alleged to have been associated with the use of our products occurs.  In addition, any product malfunction that would likely cause or contribute to a death or serious injury if the malfunction were to occur must also be reported. FDA regulations prohibit a device from being marketed for unapproved or uncleared indications.  If the FDA believes that we are not in compliance with these regulations, it may institute proceedings to detain or seize products, issue a product recall, seek injunctive relief or assess civil and criminal penalties.

 

The use and manufacture of our products are subject to OSHA and other federal, state and local laws and regulations that relate to such matters as: i) safe working conditions for healthcare workers and other employees; ii) manufacturing practices; iii) environmental protection and disposal of hazardous or potentially hazardous substances; and iv) the policies of hospitals and clinics relating to complying with these laws and regulations. There can be no assurance that we will not be required to incur significant costs to comply with these laws, regulations or policies in the future, or that such laws, regulations or policies will not increase the costs or restrictions related to the use of our products or otherwise have a materially adverse effect upon our ability to do business.

 

Laws and regulations regarding the manufacture, sale and use of medical devices are subject to change and depend heavily on administrative interpretation. There can be no assurance that future changes in regulations or interpretations made by the FDA, OSHA or other domestic and international regulatory bodies will not adversely affect us.

 

Sales of medical devices outside of the United States are subject to foreign regulatory requirements. The requirements for obtaining pre-market clearance by a foreign country may differ from those required for FDA clearance.  Devices having an effective 510(k) clearance or PMA may be exported without further FDA authorization. FDA authorization is generally required in order to export other medical devices.

 

In June 1998, we received certification from TŰV Product Services for our quality system, which meets the requirements of ISO 9001 and EN 46001. In addition, in April 2002 we were re-certified for ISO 9001-1994, EN 46001-1996 and ISO 13485-1996. In November 1999, we received certification from TUV Product Services for the applicable requirements of EC-Directive 93/42/EEC Annex. II.3 Medical Device Directive, which allows us to label our products with the CE Mark and sell them in the European Community and various non-European countries.

 

In November, 2003 we were issued a Certification from TŰV for compliance with Canadian Medical Devices Conformity Assessment System (CMDCAS), Health Canada’s requirement for recognition of third party conformity under the National Accreditation Program of the Standards Council of Canada (SCC). Bioject has a Medical Device Establishment License with Health Canada.

 

Research and Product Development

Research and product development efforts are focused on enhancing our current product offerings and on developing new needle-free injection products.  We use clinical magnetic resonance imaging, high speed photography and tissue studies to determine the reliability and performance of new and existing products.  As of December 31, 2003, our research and product development staff, including clinical and regulatory staff members, consisted of 19 employees.  Research and development expense totaled $5.2 million, $2.8 million and $2.8 million for year ended December 31, 2003, the nine-month transition period ended December 31, 2002 and the year ended March 31, 2002, respectively.

 

A primary focus of our research efforts is on clinical research in the area of DNA-based vaccines and medications. Currently, we believe our devices are being used in more than 22 clinical research projects both within and outside of the United States, approximately 14 of which are DNA-based.

 

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These research projects are being conducted by companies leading the development of DNA-based medications as well as by the leading universities and governmental institutions conducting research in this area. There can be no assurance that further clinical studies will prove conclusively that Bioject’s technology is more effective in delivering DNA-based medications than alternative delivery systems that are currently available or that may be developed in the future.

 

Developing DNA-based preventative and therapeutic treatments for a variety of diseases is a very active and growing area of medical research. Researchers hope to develop DNA-based treatments for diseases that have previously not been treatable as well as DNA-based alternatives to therapies currently used in the treatment of other diseases. Most DNA therapies currently being developed require injecting the medication either intramuscularly (into the muscle tissue) or intradermally (just under the skin). The Biojector® 2000 is currently the only jet injection device cleared by the FDA for intramuscular injections.  We have developed an adapter for the Biojector® syringe to allow the device to consistently deliver intradermal injections. This adapter is being used in clinical studies to deliver intradermal injections. Initial studies show the adapter to be effective. This adapter has not been cleared by the FDA to be marketed for intradermal injections and is not currently submitted to the FDA to gain clearance for those claims. If our jet injection technology is proven to enhance the performance of DNA-based medications, this area of medicine could present a significant opportunity for us to license our products to pharmaceutical and biotechnology companies for use in conjunction with their DNA-based medications. There can be no assurance that further clinical studies will prove conclusively that our technology is more effective in delivering DNA-based medications than alternative delivery systems that are either currently available or that may be developed in the future. Further, there can be no assurance, should our technology prove to be more effective in delivering DNA-based medications, that regulatory clearance will be gained to deliver any DNA-based medications using our products.  Further, should intradermal delivery of DNA-based medications be critical to effective delivery of those compounds, there is no assurance that we will gain regulatory clearance for intradermal delivery DNA-based medications with our products.

 

A primary focus of our product development efforts is on developing a new generation of personal injectors (the “Iject®”) that are being designed to be smaller, disposable and lightweight. We anticipate producing a family of Iject® devices, each specially customized for the delivery of specific injected drugs and vaccines, which could be licensed to pharmaceutical and biotechnology companies for many different non-competing products.

 

The Iject® is ergonomic and aesthetic, and is easily adapted for intradermal injections. These devices will target the growing market for patients administering their own injections in the home. Benefits of the Iject® are:  (i) single use, (ii) fully disposable (iii) requires minimal patient interaction, (iv) ready to use and (v) safe.

 

The Iject-R™ is designed to be a durable injection device capable of giving multiple injections using pre-filled disposable syringes and a single-use disposable gas power source. This economical, convenient and easy to use device is designed for the home use market, where frequent injections are required.

 

When the pre-filled technology is perfected, we intend to seek arrangements with pharmaceutical and biotechnology companies under which those companies will sell their medications, pre-packaged in Iject® syringes, for use in either the Iject® or the Iject-R™.  We intend to outsource the sterile fill of the Iject® syringes to a contract filler.  Purchasing Iject® syringes already filled with medication eliminates the filling and measuring procedures associated with traditional injection of medications and with injections administered with the current Biojector® syringe. Before pre-filled syringes may be distributed for use in the U.S., pharmaceutical and biotechnology companies wishing to use these syringes must commit to packaging and distributing their products in the pre-filled syringes and to the time and financial resources necessary to gain regulatory clearance to package and market their products in this manner. This process could be lengthy. In addition, the companies will have to establish that their drugs will remain chemically and pharmacologically stable when packaged and

 

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stored in a Biojector® pre-filled syringe and that a drug that is packaged, stored and delivered in this manner is safe and effective for its intended uses. See “Governmental Regulation.”

 

Manufacturing

We assemble the Biojector® 2000, the Vitajet®, the cool.click™, the SeroJet™ and related syringes from components purchased from outside suppliers. We believe that we have readily available alternative sources for all of our outside suppliers. There can be no assurance that sufficient numbers of qualified manufacturing employees will be available when needed to increase production to meet either foreseen or unforeseen demand for our products.  Further, while we believe that we continue to maintain supplier relationships that will provide a sufficient supply of materials to meet demands at full manufacturing capacity, there can be no assurance that such supplier relationships will be sufficient to meet such demand in quantities and at prices and quality levels required for us to operate efficiently and profitably.

 

Employees

As of December 31, 2003, we had 77 full-time employees, with 17 employees engaged in research and product development, 3 in business development, 2 in sales and marketing, 2 in technical product support, 33 in manufacturing (including 14 contract manufacturing workers), and 20 in administration. We engage a limited number of part-time consultants who assist with research and development and sales and marketing activities.  As of December 31, 2003, we had 2 consultants and 4 per diem nurses on contract.  None of our employees are represented by a labor union.

 

Product Liability

We believe that our products reliably inject medications both subcutaneously and intramuscularly  when used in accordance with product guidelines.  Our current insurance  policies provide coverage at least equal to an aggregate of $11 million with respect to certain product liability claims.  We have experienced one product liability claim to date, and did not incur a significant liability.  There can be no assurance, however, that we will not become subject to more such claims, that our current insurance would cover such claims, or that insurance will continue to be available to us in the future. Our business may be adversely affected by product liability claims.

 

Factors That May Affect Our Business and Our Common Stock

 

If our products are not accepted by the market, our business could fail.  Our success will depend on market acceptance of our needle-free injection drug delivery systems, the Biojector® 2000 system and the Vitajet® system and on market acceptance of other products under development.  If our products do not achieve market acceptance, our business could fail. Currently, the dominant technology used for intramuscular and subcutaneous injections is the hollow-needle syringe.  Use of the Biojector® 2000 system for intramuscular and subcutaneous injections eliminates the risk associated with needle syringes; however, the cost per injection is significantly higher.  The Biojector® 2000, the Iject® system, the Vitajet® system or any of our products under development may be unable to compete successfully with needle-syringes. A previous needle-free injection system manufactured by us did not achieve market acceptance and is no longer being marketed.

 

We may be unable to enter into additional strategic corporate licensing and distribution agreements or maintain existing agreements, which could cause our business to suffer.  A key component of our sales and marketing strategy is to enter into licensing and supply arrangements with leading pharmaceutical and biotechnology companies for whose products our technology provides either increased medical effectiveness or a higher degree of market acceptance.  If we cannot enter into these agreements on terms favorable to us or at all, our business may suffer.

 

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Several agreements, including those with Hoffman La Roche Pharmaceuticals, Merck & Co. and Amgen, have been canceled prior to completion.  These agreements resulted in significant short-term revenue. However, none of these agreements developed into the long-term revenue stream anticipated by our strategic partnering strategy.

 

We may be unable to enter into future licensing or supply agreements with major pharmaceutical or biotechnology companies.  Even if we enter into these agreements, they may not result in sustainable long-term revenues which, when combined with revenues from product sales, could be sufficient for us to operate profitably.

 

We have a history of losses and may never be profitable.  Since our formation in 1985, we have incurred significant annual operating losses and negative cash flow.  At December 31, 2003, we had an accumulated deficit of $90.4 million. Of that amount, $77.3 million of the accumulated deficit relates to losses incurred in the needle-free segment of our operations.  Approximately $13.1 million of the accumulated deficit relates to losses from our operations to develop blood glucose monitoring technology, which was discontinued and sold to a third party in fiscal 2000. We may never be profitable, which could have a negative effect on our stock price.  Historically, our revenues have been derived primarily from licensing and technology fees and from limited product sales. The product sales were principally sales to dealers in order to stock their inventories and to Homecare Management Inc., a company that we no longer sell to.  More recently, we have sold our products to strategic partners, who market our products under their brand name and to end-users such as public health clinics for vaccinations and nursing organizations for flu immunizations.  We have not attained profitability at these sales levels.  We may never be able to generate significant revenues or achieve profitability. In the future, we are likely to require substantial additional financing.  Such financing may not be available on terms favorable to us, or at all, which would have a material adverse effect on our business.

 

We have a small sales force and may be unable to penetrate targeted market segments.

Our sales force consists of one national sales manager who is focused on specifically targeted market segments. Our small sales force may not have sufficient resources to adequately penetrate one or more of the targeted market segments. Further, if the sales force is successful in penetrating one or more of the targeted market segments, we are unable to assure that our products will be accepted in those segments or that product acceptance will result in product revenues which, together with revenues from corporate licensing and supply agreements, will be sufficient for us to operate profitably.

 

We have limited manufacturing experience, and may be unable to produce our products at the unit costs necessary for the products to be competitive in the market, which could cause our financial condition to suffer.   We have limited experience manufacturing our products in commercially viable quantities. We have increased our production capacity for the Biojector® 2000 system and the Vitajet® product line through automation of, and changes in, production methods, in order to achieve savings through higher volumes of production.  If we are unable to achieve these savings, our results of operations and financial condition could suffer. The current cost per injection of the Biojector® 2000 system and Vitajet® product line is substantially higher than that of traditional needle-syringes, our principal competition.  A key element of our business strategy has been to reduce the overall manufacturing cost through automating production and packaging.  There can be no assurance that we will achieve sales and manufacturing volumes necessary to realize cost savings from volume production at levels necessary to result in significant unit manufacturing cost reductions. Failure to do so will continue to make competing with needle-syringes on the basis of cost very difficult and will adversely affect our financial condition and results of operations. We may be unable to successfully manufacture devices at a unit cost that will allow the product to be sold profitably. Failure to do so would adversely affect our financial condition and results of operations.

 

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We are subject to extensive government regulation and must continue to comply with these regulations or our business could suffer.    Our products and manufacturing operations are subject to extensive government regulation in both the U.S. and abroad. If we cannot comply with these regulations, we may be unable to distribute our products, which could cause our business to suffer or fail. 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, we received clearance from the FDA under Section 510(k) of the FFDCA to market a hand-held CO2-powered needle-free injection system. The FFDCA provides that new pre-market 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 our 1987 510(k) marketing clearance was received and expands its intended use, we 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, we further concluded that the 1987 510(k) clearance permitted us to market the Biojector® 2000 system in the U.S. In June 1994, we received clearance from the FDA under 510(k) to market a version of our Biojector® 2000 system in a configuration targeted at high volume injection applications.  In October 1996, we received 510(k) clearance for a needle-free disposable Vial Adapter device.  In March 1997, we received additional 510(k) clearance for certain enhancements to our Biojector® 2000 system. In June 2000, we received 510(k) clearance for the cool.click™, a modified Vitajet®.  In March 2001, we received 510(k) clearance for the SeroJet™, also a modified Vitajet®.  In April 2001, we received 510(k) clearance to market a reconstitution kit and Vial Adapter. The FDA may not concur with our determination that our current and future products can be qualified by means of a 510(k) submission.

 

Future changes to manufacturing procedures could require that we file 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 pre-market 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 pre-filled syringes would be evaluated by the FDA as drugs rather than devices, requiring FDA new drug applications or abbreviated new drug applications. Depending on the circumstances, drug regulation can be much more extensive and time consuming than device regulation.

 

FDA regulatory processes are time consuming and expensive. Product applications submitted by us may not be cleared or approved by the FDA. In addition, our products must be manufactured in compliance with Good Manufacturing Practices, as specified in regulations under the FFDCA. The FDA has broad discretion in enforcing the FFDCA, and noncompliance with the FFDCA 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.

 

If we cannot meet international product standards, we will be unable to distribute our products outside of the United States, which could cause our business to suffer. Distribution of our products in countries other than the U.S. may be subject to regulation in those countries. Failure to satisfy these regulations would impact our ability to sell our products in these countries and could cause our business to suffer. In January 1999, we received certification from TUV Product Services for our quality system, which meets the requirements of ISO 9001 and EN 46001.  In November 1999, we received certification from TUV Product Services for the applicable requirements of EC-Directive 93/42/EEC Annex. II.3 Medical Device Directive. In April 2002 we received certification for ISO 9001-1994, EN 46001-1996 and ISO 13485-1996, which allows us to label our products with the CE Mark and sell them in the European Community and non European countries.  We may be unable to continue to meet the standards of ISO 9001 or CE Mark certification.

 

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If the healthcare industry limits coverage or reimbursement levels, the acceptance of our products could suffer.  The price of our products exceeds the price of needle-syringes and, if coverage or reimbursement levels are reduced, market acceptance of our products could be harmed. 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 payers 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 and Vitajet® product line exceeds the price of a needle-syringe, cost control policies of third party payers, including government agencies, may adversely affect acceptance and use of the Biojector® 2000 system and Vitajet® product line.

 

We depend on outside suppliers for manufacturing.  Our current manufacturing processes for the Biojector® 2000 jet injector and disposable syringes as well as manufacturing processes to produce the Vitajet® consist primarily of assembling component parts supplied by outside suppliers. Some of these components are currently obtained from single sources, with some components requiring significant production lead times. In the past, we have experienced delays in the delivery of certain components. To date, such delays have not had a material adverse effect on our operations.  We may experience delays in the future, and these delays could have a material adverse effect on our financial condition and results of operations.

 

If we are unable to manage our growth, our results of operations could suffer.  If our products achieve market acceptance or if we are successful in entering into product supply agreements with major pharmaceutical or biotechnology companies, we expect to experience rapid growth. Such growth would require expanded customer service and support, increased personnel, expanded operational and financial systems, and implementing new and expanded control procedures. We may be unable to attract sufficient qualified personnel or successfully manage expanded operations.  As we expand, we may periodically experience constraints that would adversely affect our ability to satisfy customer demand in a timely fashion.  Failure to manage growth effectively could adversely affect our financial condition and results of operations.

 

We may be unable to compete in the medical equipment field, which could cause our business to fail.   The medical equipment market is highly competitive and competition is likely to intensify. If we cannot compete, our business will fail. Our products compete primarily with traditional needle-syringes, “safety syringes” and also with other alternative drug delivery systems. While we believe our products provide a superior drug delivery method, there can be no assurance that we will be able to compete successfully with existing or newly developed drug delivery products. Many of our competitors have longer operating histories as well as substantially greater financial, technical, marketing and customer support resources. One or more of these competitors may develop an alternative drug delivery system that competes more directly with our products, and our products may be unable to compete successfully with such a product.

 

We are dependent on a single technology, and if it cannot compete or find market acceptance, our business will suffer.    Our strategy has been to focus our development and marketing efforts on our needle-free injection technology. Focus on this single technology leaves us vulnerable to competing products and alternative drug delivery systems. If our technology cannot find market acceptance or cannot compete against other technologies, business will suffer. We perceive 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, nasal delivery systems and transdermal diffusion “patches.” In addition, pharmaceutical companies frequently attempt to develop drugs for oral delivery instead of injection.  While we believe that for the foreseeable future there will continue to be a significant need for injections, alternative drug delivery methods may be developed which are preferable to injection.

 

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We rely on patents and proprietary rights to protect our proprietary technology.    We rely on a combination of trade secrets, confidentiality agreements and procedures and patents to protect our proprietary technologies. We have been granted a number of patents in the United States and several patents in other countries covering certain technology embodied in our current jet injection system and certain manufacturing processes.  Additional patent applications are pending in the U.S. and certain foreign countries. The claims contained in any patent application may not be allowed, or any patent or our patents collectively may not provide adequate protection for our products and technology. In the absence of patent protection, we may be vulnerable to competitors who attempt to copy our products or gain access to our trade secrets and know-how. In addition, the laws of foreign countries may not protect our proprietary rights to this technology to the same extent as the laws of the U.S. We believe we have independently developed our technology and attempt to ensure that our products do not infringe the proprietary rights of others. We know of no such infringement claims.  However, any claims could have a material adverse effect on our financial condition and results of operations.

 

If our products fail or cause harm, we could be subject to substantial product liability, which could cause our business to suffer.    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. We currently maintain product liability insurance and, to date, have experienced only one product liability claim. There can be no assurance, however, that we will not be subject to a number of such claims, that our product liability insurance would cover such claims, or that adequate insurance will continue to be available to us on acceptable terms in the future. Our business could be adversely affected by product liability claims or by the cost of insuring against such claims.

 

We are highly dependent on our key employees, and our business could suffer if they were to leave. Our success depends on the retention of our executive officers, Mr. James O’Shea, Mr. John Gandolfo, Mr. Michael Temple and other key officers and employees. Competition exists for qualified personnel and our success will depend, in part, on attracting and retaining qualified personnel. Failure in these efforts could have a material adverse effect on our business, financial condition or results of operations.

 

There are a large number of shares eligible for sale into the public market in the near future, which may reduce the price of our common stock.    The market price of our common stock could decline as a result of sales of a large number of shares of our common stock in the market, or the perception that such sales could occur. We have a large number of shares of common stock outstanding and available for resale beginning at various points in time in the future. These sales also might make it more difficult for us to sell equity securities in the future at a time and at a price that we deem appropriate. 520,088 shares of our common stock currently outstanding are eligible for sale without registration pursuant to Rule 144 under the Securities Act, subject to certain conditions of Rule 144. The holder of these shares also has certain demand and piggyback registration rights enabling it to register its shares under the Securities Act for sale. We have registered approximately 12.0 million shares for resale on Form S-3 registration statements, including approximately 1.2 million shares issuable upon exercise of warrants.  In addition, we have 846,178 shares of common stock reserved for future issuance under our stock option plan. As of December 31, 2003, options to purchase approximately 2.7 million shares of common stock were outstanding and will be eligible for sale in the public market from time to time subject to vesting.

 

Our stock price may be highly volatile, which increases the risk of securities litigation.   The market for our common stock and for the securities of other early-stage, small market-capitalization companies has been highly volatile in recent years. This increases the risk of securities litigation relating to such volatility. We believe that factors such as quarter-to-quarter fluctuations in financial results, reduction in the number of outstanding shares due to the 1999 reverse stock split, new product introductions by us or our competition, public announcements, changing regulatory environments, sales of common stock by certain existing shareholders, substantial product orders and announcement of licensing or product supply agreements with major pharmaceutical or biotechnology companies could contribute to the volatility of the price of our common stock, causing it to fluctuate

 

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dramatically. General economic trends such as recessionary cycles and changing interest rates may also adversely affect the market price of our common stock.

 

Item 2.   PROPERTIES

 

In April 2004, we will move our principal manufacturing and support facilities to a new space located in Portland, Oregon. This new space is approximately 40,500 square feet of leased office and manufacturing space. The lease, which expires October 31, 2014, has one option to extend for an additional five year term. The rent is approximately $34,000 per month averaged over the life of the lease term.  Our current space lease expires June 30, 2004.

 

This facility includes our sales and certain administration offices, research and engineering facilities and manufacturing facilities. The manufacturing facilities include a clean room assembly area, assembly line, testing facilities and warehouse area.

 

Our executive and certain other offices are located in a 5,000 square foot facility in New Jersey, which is owned by us.

 

We also lease additional warehouse space in Portland, Oregon, totaling approximately 5,000 square feet, for finished goods storage and shipments to customers.  This lease, which expires in September 2004, has a five-year renewal option, and minimum monthly lease obligations totaling $2,300. We do not plan to renew this lease.  Upon termination of the lease, we will house such storage at our main facility in Portland, Oregon.

 

We believe that our new facility will be sufficient to support our anticipated manufacturing operations and other needs for at least the next ten years.  We believe that, if necessary, we will be able to obtain alternative facilities at rates and under terms comparable to those of the current leases.

 

Item 3.   LEGAL PROCEEDINGS

 

As of the date of filing this Form 10-K, we are not a party to any litigation that could have a material adverse effect on our financial position or results of operations.

 

Item 4.   SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS

 

None.

 

18



 

PART II

 

Item 5.        MARKET FOR THE REGISTRANT’S COMMON EQUITY AND RELATED STOCKHOLDER MATTERS

 

Our common stock trades on the Nasdaq SmallCap Market under the symbol “BJCT.”   The following  table sets forth the high and low closing sale prices of our common stock for each quarter in the two years ended December 31, 2003.

 

Year Ended December 31, 2002

 

High

 

Low

 

Quarter 1

 

$

13.30

 

$

3.84

 

Quarter 2

 

4.78

 

3.10

 

Quarter 3

 

4.00

 

1.70

 

Quarter 4

 

2.93

 

1.90

 

 

Year Ended December 31, 2003

 

High

 

Low

 

Quarter 1

 

$

3.94

 

$

1.99

 

Quarter 2

 

5.46

 

3.00

 

Quarter 3

 

4.42

 

3.49

 

Quarter 4

 

3.91

 

2.35

 

 

As of March 2, 2004, there were 1,031 shareholders of record and approximately 7,200 beneficial shareholders.

 

We have not declared any dividends during our history and have no intention of declaring a dividend in the foreseeable future.

 

See Item 12. for Equity Compensation Plan Information.

 

19



 

Item 6.        SELECTED CONSOLIDATED FINANCIAL DATA

 

The consolidated statement of operations and balance sheet data set forth below for the three fiscal years ended March 31, 2002, the nine-month period ended December 31, 2002 and the year ended December 31, 2003 have been derived from our consolidated financial statements. The selected consolidated financial data set forth below should be read in conjunction with “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and with the consolidated financial statements and notes thereto included elsewhere in this Form 10-K.

 

SELECTED CONSOLIDATED FINANCIAL INFORMATION

(in thousands, except per share data)

 

 

 

For the year
ended
December 31,
2003

 

For the nine
months
ended
December 31,
2002
(1)

 

For the year ended March 31,

 

 

 

 

 

2002

 

2001

 

2000

 

Consolidated Statement of Operations Data

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Revenue

 

$

6,320

 

$

4,304

 

$

5,219

 

$

2,033

 

$

1,280

 

Operating expenses

 

15,904

 

10,272

 

12,309

 

7,754

 

5,726

 

Loss from continuing operations allocable to common shareholders

 

(9,332

)

(5,465

)

(8,491

)

(6,025

)

(5,484

)

Income from discontinued operations allocable to common shareholders

 

 

 

 

 

2,403

 

Net loss allocable to common shareholders

 

(9,332

)

(5,465

)

(8,491

)

(6,025

)

(3,081

)

Basic and diluted loss per common share from continuing operations

 

(0.87

)

(0.52

)

(0.87

)

(0.82

)

(0.94

)

Basic and diluted loss per common share from discontinued operations

 

 

 

 

 

(0.08

)

Basic and diluted income per common share from sale of discontinued operations

 

 

 

 

 

0.49

 

Basic and diluted loss per common share

 

(0.87

)

(0.52

)

(0.87

)

(0.82

)

(0.53

)

Shares used in per common share calculations

 

10,720

 

10,596

 

9,778

 

7,339

 

5,834

 

 

 

 

December 31,

 

March 31,

 

 

 

2003

 

2002

 

2002

 

2001

 

2000

 

Consolidated Balance Sheet Data

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Working capital

 

$

9,521

 

$

18,313

 

$

13,414

 

$

12,871

 

$

6,931

 

Total assets

 

22,468

 

28,234

 

33,469

 

17,989

 

9,814

 

Current portion of long-term debt

 

175

 

 

 

 

 

Long-term debt, less current portion

 

1,325

 

 

 

 

 

Long-term capital lease payable

 

82

 

26

 

6

 

16

 

 

Shareholders’ equity

 

17,956

 

26,867

 

31,966

 

16,674

 

8,837

 

 


(1) Includes only nine months of operations data due to the change in our fiscal year during 2002 to a fiscal year ending December 31 from a fiscal year ending March 31.

 

20



 

Item 7.                       MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

FORWARD LOOKING STATEMENTS

 

This Annual Report on Form 10-K contains forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements concerning future financial results, prospects for future strategic corporate relationships, current corporate partners, prospects for sales of our products into new, high leverage markets and generally heightened prospects for the adoption and use of needle-free technology. Such forward looking statements (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,” “should,” “might” or “will” be taken, occur or be achieved) involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements, 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 other factors include, without limitation, such risks as the risk that our products, including the cool.click™, the SeroJet™ or the Vial Adapter, will not be accepted by the market, the risk that we will be unable to enter into additional strategic corporate licensing and supply agreements or maintain existing agreements, the fact that our business has never been profitable and may never be profitable, uncertainties related to the time required to complete research and development, obtaining necessary clinical data and government clearances, the risk that we may be unable to produce our products at a unit cost necessary for the products to be competitive in the market and the risk that we may be unable to comply with the extensive government regulations applicable to our business.

 

Forward-looking statements are based on the estimates and opinions of management on the date the statements are made.  We assume no obligation to update forward-looking statements if conditions or management’s estimates or opinions should change, even if new information becomes available or other events occur in the future.

 

OVERVIEW

 

We develop needle-free injection systems that improve the way patients take medications and vaccines.

 

In fiscal 2002, we changed our fiscal year end from March 31 to December 31. The following discussion should be read in conjunction with the Consolidated Financial Statements and the Notes thereto prepared in accordance with U.S. GAAP contained elsewhere in this Form 10-K. The following discussion and analysis explains trends in our financial condition and results of operations for the year ended December 31, 2003 compared to year ended December 31, 2002 (unaudited) and for the nine months ended December 31, 2002 and the nine months ended December 31, 2001 (unaudited).

 

During 2003, we had the largest number of patents granted in our history, with a total of seven patents issued in the U.S.  In addition, another eight U.S. patents were applied for. The patents issued and applied for reflect new technology for needle-free products, as well as innovations which are extending existing technology platforms.  Among the patents granted are important innovations with our single-use, pre-filled Iject® and an evolution of the Iject® platform to allow it to be reusable.  Other patents included an evolution of the Iject® which has fewer parts and is easier to manufacture, as well as a high work load injector for biodefense and mass immunization.

 

Our long-term goal is to become the leading supplier of needle-free injection systems to the pharmaceutical and biotech industries. In 2004, we will continue to focus our business development efforts on new and existing licensing and supply agreements with leading pharmaceutical and biotechnology companies. By bundling customized needle-free delivery systems with partners’ injectable medications and vaccines, we can enhance demand for these products in the healthcare provider and end user markets.

 

21



 

In 2004, our clinical research efforts will continue to be aimed primarily at clinical research collaborations in the areas of vaccines and drug delivery.  Currently, we are involved in collaborations with 22 institutions.

 

In 2004, our other research and development efforts will focus on moving our 0.5 mL and our 1.0 mL Iject® from the clinical phase to the production phase, which includes bringing on line our sterile fill capabilities. In addition, we continue to work on product improvements to existing devices and development of products for our strategic partners.

 

Revenues and results of operations have fluctuated and can be expected to continue to fluctuate significantly from quarter to quarter and from year to year. Various factors may affect quarterly and yearly operating results including: i) the length of time to close product sales; ii) customer budget cycles; iii) the implementation of cost reduction measures; iv) uncertainties and changes in product sales due to third party payer policies and proposals relating to healthcare cost containment; v) the timing and amount of payments under licensing and technology development agreements; and vi) the timing of new product introductions by us and our competitors.

 

CASH REQUIREMENTS FOR 2004

 

Based on our financial position at December 31, 2003 and our projected revenues, we anticipate having adequate capital resources to fund our operations and anticipated capital expenditures through 2005. Cash requirements for 2004 are estimated to total approximately $7.6 million as follows:

 

Estimated cash required for 2004 operations

 

$

6,400,000

 

Current portion of long-term debt

 

175,000

 

Current portion of capital leases

 

41,000

 

Estimated cash capital expenditures

 

1,000,000

 

 

 

$

7,616,000

 

 

2004 FINANCIAL OUTLOOK

 

For the twelve months ending December 31, 2004, we currently estimate revenues of approximately $8.5 million to $10.0 million and a net loss of approximately $6.5 million to $7.1 million, or approximately $0.49 to $0.53 per share based upon approximately 13.5 million shares outstanding. The 2004 estimates are based upon projected revenues from existing customers and anticipated revenues from potential new partners, which agreements we feel are likely to close during 2004, as well as anticipated expenses for 2004.

 

22



 

RESULTS OF OPERATIONS

 

YEAR ENDED DECEMBER 31, 2003 COMPARED TO THE YEAR ENDED DECEMBER 31, 2002

 

Due to the fiscal year end change to December 31, the fiscal year ended December 31, 2002 is comprised of only nine months. In order to provide a more meaningful comparison and discussion of trends in revenues and expenses, the consolidated financial data for the twelve-month periods ended December 31, 2003 and December 31, 2002 are presented in the following table and the results of these two periods are used in the discussion thereafter.

 

 

 

Year Ended
December 31, 2003

 

Year Ended
December 31, 2002

 

 

 

 

 

(Unaudited)

 

Revenue:

 

 

 

 

 

Net sales of products

 

$

5,314,256

 

$

4,093,750

 

Licensing and technology fees

 

1,005,464

 

2,718,142

 

 

 

6,319,720

 

6,811,892

 

Operating expenses:

 

 

 

 

 

Manufacturing

 

5,181,167

 

5,319,045

 

Research and development

 

5,164,338

 

3,866,058

 

Selling, general and administrative

 

5,558,269

 

5,433,206

 

Total operating expenses

 

15,903,774

 

14,618,309

 

Operating loss

 

(9,584,054

)

(7,806,417

)

 

 

 

 

 

 

Interest income

 

259,862

 

672,626

 

Other expense

 

(8,042

)

(95,437

)

 

 

251,820

 

577,189

 

Net loss allocable to common shareholders

 

$

(9,332,234

)

$

(7,229,228

)

Basic and diluted net loss per common share

 

$

(0.87

)

$

(0.68

)

Shares used in per share calculations

 

10,719,902

 

10,644,877

 

 

Product sales increased primarily due to increased Vial Adapter sales to Amgen. Amgen packages the Vial Adapter with one of their drugs for resale to the end user.  The increase was partially offset by reduced SeroJet™ sales, which were $107,000 in 2003 compared to $708,000 in 2002.   We expect increased Biojector® 2000 sales in 2004 as a result of our continued work with the U.S. military and the National Institutes of Health.

 

License and technology revenues decreased primarily due to the timing of revenue recognition (see discussion of deferred revenue below) and the recognition of a $1.0 million non-refundable development fee in 2002, which was received from Amgen.  This fee was received in the quarter ended December 31, 2001 and was to be recognized over the term of the agreement with Amgen.  However, in the quarter ended March 31, 2002, Amgen terminated its license and development agreement and, accordingly, we recognized the entire $1.0 million in that quarter. We currently have active licensing and/or development agreements with Serono and Merial, whereas in 2002, we also had agreements with Amgen and Elan.

 

Manufacturing expense is made up of the cost of products sold and manufacturing overhead expense related to excess manufacturing capacity. At our current facility, we do not have adequate space to add additional manufacturing lines necessary to fulfill our projected Iject® and other product requirements in future years. However, we are scheduled to move to a new facility in April 2004, at which time we will add such manufacturing capacity. The decreased manufacturing expense in 2003 is primarily due to $497,000 of costs related to inventory scrap and obsolescence in 2002 that were not incurred in 2003. This decrease was partially offset by increased sales volume and expenses related to the start-up and validation of our Vial Adapter line.  Included in our anticipated 2004 capital expenditures are amounts to further automate and streamline certain manufacturing processes.

 

23



 

Research and development expense in 2003 primarily relates to costs incurred in relation to the development of the Iject®, including sterile fill and clinical studies, the Vetjet™ for Merial and for enhancements to our Vitajet™ spring-powered product.  The $1.3 million increase in research and development expense in 2003 compared to 2002 was due to approximately $430,000 in initial set-up costs for our sterile fill capabilities and a $900,000 increase in amounts spent on further development of our Iject® product.  As discussed above, in 2004 we plan to focus on moving our 0.5 mL and our 1.0 mL Iject® from the clinical phase to the production phase, including the completion of our automated sterile fill capabilities.

 

The slight increase in selling, general and administrative expenses in 2003 compared to 2002 was due to increases in labor and legal costs being mostly offset by lower consulting costs.   We expect selling, general and administrative costs to remain relatively constant in 2004 compared to 2003.

 

Interest income decreased due primarily to lower interest rates and lower cash and investment balances in 2003 compared to 2002.  The lower cash and investment balances are due to the fact that we have not raised any capital since December 2001 and, therefore, have been utilizing existing cash and investment balances for operations.

 

NINE MONTHS ENDED DECEMBER 31, 2002 COMPARED TO NINE MONTHS ENDED DECEMBER 31, 2001

 

Due to the fiscal year end change to December 31, the fiscal year ended December 31, 2002 is comprised of only nine months. In order to provide a more meaningful comparison and discussion of trends in revenues and expenses, the consolidated financial data for the nine-month periods ended December 31, 2002 and December 31, 2001 are presented in the following table and the results of these two periods are used in the discussion thereafter.

 

 

 

Nine Months
Ended December
31, 2002

 

Nine Months
Ended December
31, 2001

 

 

 

 

 

(Unaudited)

 

Revenue:

 

 

 

 

 

Net sales of products

 

$

2,971,407

 

$

2,112,779

 

Licensing and technology fees

 

1,332,194

 

597,675

 

 

 

4,303,601

 

2,710,454

 

Operating expenses:

 

 

 

 

 

Manufacturing

 

3,558,532

 

2,957,686

 

Research and development

 

2,842,127

 

1,807,035

 

Selling, general and administrative

 

3,871,139

 

3,197,331

 

Total operating expenses

 

10,271,798

 

7,962,052

 

Operating loss

 

(5,968,197

)

(5,251,598

)

 

 

 

 

 

 

Interest income

 

504,911

 

1,044,156

 

Other expense

 

(2,185

)

 

 

 

502,726

 

1,044,156

 

Loss before preferred stock dividend

 

(5,465,471

)

(4,207,442

)

Preferred stock dividend

 

 

(2,519,407

)

Net loss allocable to common shareholders

 

$

(5,465,471

)

$

(6,726,849

)

Basic and diluted net loss per common share

 

$

(0.52

)

$

(0.71

)

Shares used in per share calculations

 

10,595,613

 

9,532,913

 

 

24



 

Product sales in the nine months ended December 31, 2002 and 2001 were primarily sales of our B2000 gas-powered product line and the spring-powered product line which includes the cool.click™, which is sold to Serono for use with Saizen®, Serono’s pediatric human growth hormone.  The 2002 period sales included $581,000 of Vial Adapter sales compared to $143,000 in the 2001 period.  In addition to selling in the U.S., in September 2002, Serono began selling Saizen® for administration with the cool.click™ worldwide.

 

License and technology revenues increased for the nine month period ended December 31, 2002, compared to the same period in 2001 due primarily to licensing and technology development fees received from Merial during the 2002 period.  In addition to Merial, we received license fees or technology development fees from Serono, Alkermes and Elan during the 2002 period.

 

Manufacturing expense is made up of the cost of products sold and manufacturing overhead expense related to excess manufacturing capacity. Manufacturing expense increased in the nine month period ended December 31, 2002 due to a 60% increase in unit sales volumes, which was partially offset by lower unit costs for the product mix sold.

 

Research and development expense increased by $1.0 million in the 2002 period compared to the 2001 period due to increased payroll and related expenses and expenses associated with research collaborations, the development of the Iject® disposable product, the Iject-R™ reusable product, development of Vetjet™ for Merial and various other new product developments.

 

Approximately $223,000 of the increase in selling, general and administrative expenses in the 2002 period compared to the 2001 period resulted from non-cash charges relating to the issuance of common stock, stock options and warrants for consulting services and the issuance of restricted stock to each current non-employee director in lieu of cash compensation.  The remaining increase was primarily attributable to increases in payroll and related expenses and professional fees.

 

Interest income decreased by $539,000 in the 2002 period compared to the 2001 period as a result of lower interest rates and lower average cash and investment balances.  We did not raise any capital during the 2002 period and therefore have been utilizing our existing cash and investment balances for operations.

 

Preferred dividends of $2.5 million in the 2001 period include a $1.7 million non-cash charge related to the changes made to the rights of the outstanding Series A Preferred Stock held by Elan.  In connection with the agreement, dividend charges ceased on a prospective basis, beginning with the quarter ended March 31, 2002.

 

LIQUIDITY AND CAPITAL RESOURCES

 

Since our inception in 1985, we have financed our operations, working capital needs and capital expenditures primarily from private placements of securities, the exercise of stock options and warrants, proceeds received from our initial public offering in 1986, proceeds received from a public offering of common stock in November 1993, licensing and technology revenues and revenues from sales of products.

 

Total cash, cash equivalents, short and long-term marketable securities and restricted funds at December 31, 2003 were $13.7 million compared to $22.4 million at December 31, 2002.  Included in this amount is $1.5 million of restricted funds which is provided as security for a loan used for capital equipment.  Working capital at December 31, 2003 was $9.5 million compared to $18.3 million at December 31, 2002.

 

The decrease in cash, cash equivalents and short and long-term marketable securities during 2003 resulted primarily from $7.8 million used in operations, $2.2 million used for capital expenditures and $263,000 used for other investing activities, primarily patent applications.

 

25



 

Net accounts receivable increased to $1.3 million at December 31, 2003 from $562,000 at December 31, 2002 due primarily to the timing of payments received from and shipments to Amgen.  Included in the balance at December 31, 2003, was $1.1 million due from Amgen related to Vial Adapter sales, $392,000 of which was past due.  Subsequent to December 31, 2003, we received all $1.1 million due from Amgen.  We do not anticipate a problem with collecting the entire amount due from Amgen.

 

Receivable from related party, current and long-term, totaling $74,000 at December 31, 2003, relates to a three-year, non-interest bearing loan to our Chief Executive Officer related to his relocation from Oregon to New Jersey.  The note is being forgiven over the three-year term of the note, beginning January 2002, so long as he remains our Chief Executive Officer.

 

Inventories of $1.4 million at December 31, 2003 primarily include raw materials and finished goods for the Vial Adapter and the cool.click™ product line.  We anticipate building an extra $250,000 of inventory in the first quarter of 2004 prior to our move in order to ensure an uninterrupted supply to our customers.

 

Capital expenditures of $1.5 million (excluding $92,000 of equipment purchased with capital leases) in 2003 were primarily for the purchase of production molds for manufacturing and production automation for sterile fill for our Iject® disposable product and our Vial Adapter product.  We anticipate spending up to a total of $2.0 million in 2004 for production molds and manufacturing capabilities.

 

Accounts payable increased to $1.1 million at December 31, 2003 from $470,000 at December 31, 2002 due primarily to inventory purchases and purchases related to capital expenditures late in the quarter.

 

Deferred revenue totaled $919,000 at December 31, 2003 compared to $319,000 at December 31, 2002.  The balance at December 31, 2003 represents amounts received from Serono and Merial pursuant to the terms of their development and licensing agreements and non-refundable deposits received from potential licensing partners. See “Critical Accounting Policies — Revenue Recognition for Product Development and License Fee Revenues.”

 

In November 2003, we entered into a $1.5 million loan agreement with U.S. Bank for the purpose of purchasing capital equipment, which bears interest at the prime rate (4.0% at December 31, 2003) and is due May 31, 2004.  At December 31, 2003, $1.5 million was outstanding under this agreement and we had a $1.5 million certificate of deposit collateralizing the loan amount.  We also have a financing commitment from U.S. Bank to convert the $1.5 million loan to a five-year term loan bearing interest at U.S. Bank’s cost-of-funds rate plus 2.25% prior to May 31, 2004.  At December 31, 2003, this rate would have been 5.20%.  Interest is due monthly on this loan.

 

CONTRACTUAL PAYMENT OBLIGATIONS

 

A summary of our contractual commitments and obligations as of December 31, 2003 is as follows (in thousands):

 

Contractual
Obligation

 

Payments Due By Period

 

 

Total

 

2004

 

2005 and
2006

 

2007 and
2008

 

2009 and
beyond

 

Long-Term Debt

 

$

1,500,000

 

$

175,000

 

$

600,000

 

$

600,000

 

$

125,000

 

Capital Commitments

 

596,135

 

596,135

 

 

 

 

Operating Leases

 

4,041,943

 

191,613

 

687,455

 

716,819

 

2,446,056

 

Capital Leases

 

139,408

 

40,656

 

74,872

 

23,880

 

 

Purchase Order  Commitments

 

367,657

 

367,657

 

 

 

 

 

 

$

6,645,143

 

$

1,371,061

 

$

1,362,327

 

$

1,340,699

 

$

2,571,056

 

 

26



 

NEW ACCOUNTING PRONOUNCEMENTS

 

See Note 13. of Notes to Consolidated Financial Statements included under Part II, Item 8. of this Annual Report on Form 10-K.

 

CRITICAL ACCOUNTING POLICIES AND ESTIMATES

 

The preparation of our financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses.  Our estimates are based on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources.

 

Our critical accounting policies and estimates include the following:

      revenue recognition for product development and license fee revenues;

      inventory valuation; and

      long-lived asset impairment.

 

Revenue Recognition for Product Development and License Fee Revenues

In accordance with Staff Accounting Bulletin 104 (“SAB 104”), “Revenue Recognition,” product development revenue is recognized on a percentage of completion basis as qualifying expenditures are incurred and licensing revenues, if separable, are recognized over the term of the license agreement.  The FASB’s Emerging Issues Task Force (EITF) 00-21 “Accounting for Multiple Element Arrangements” requires arrangements with multiple elements to be broken out as separate units of accounting based on their relative fair values. Revenue for a separate unit of accounting should be recognized only if the amount due can be reliably measured and the earnings process is substantially complete.  Any units that cannot be separated must be accounted for as a combined unit. Our accounting policy is consistent with EITF 00-21. Should agreements be terminated prior to completion or our estimates of percentage of completion be incorrect, we could have unanticipated fluctuations in our revenue on a quarterly basis.  Amounts received prior to meeting recognition criteria are recorded on our balance sheet as deferred revenues and are recognized according to the terms of the associated agreements. The balance of $919,000 at December 31, 2003 represents amounts received from Serono and Merial pursuant to their agreements and non-refundable deposits received from potential licensing partners.

 

Inventory Valuation

We regularly evaluate the realizability of our inventory based on a combination of factors, including the following: historical and forecasted sales and usage rates, anticipated technology improvements and product upgrades, as well as other factors.  All inventories are reviewed quarterly to determine if inventory carrying costs exceed market selling prices and if certain components have become obsolete. We record valuation adjustments for inventory based on the above factors.  If circumstances related to our inventories change, our estimates of the realizability of inventory could materially change.

 

Long-Lived Asset Impairment

We regularly evaluate our long-lived assets and certain identified intangible assets for impairment in accordance with SFAS No. 144, “Accounting for the Impairment or Disposal of Long-Lived Assets,” which requires us to review our long-lived assets and certain identifiable intangible assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset might not be recoverable utilizing an undiscounted cash flow analysis. Based on these analyses, we did not recognize any impairment on our long-lived assets during the periods presented.  If circumstances related to our long-lived assets change, we may record an impairment charge in the future.

 

27



 

Item 7A.  QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

Our exposure to market risk for changes in interest rates relates primarily to our investment portfolio. We mitigate this risk by diversifying investments among high credit quality securities in accordance with our investment policy. As of December 31, 2003, our investment portfolio included cash, cash equivalents and marketable corporate debt securities of $3.5 million and federal government debt securities of $8.7 million.  The debt securities are subject to interest rate risk, and will decline in value if interest rates increase.  Due to the short duration of our investment portfolio, an immediate 10 percent increase in interest rates would not have a material effect on our financial condition or results of operations.

 
Item 8.                                   CONSOLIDATED FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

 

The information required by this item begins on the following page.

 

28


Independent Auditors’ Report

 

The Board of Directors and Shareholders
Bioject Medical Technologies Inc.:

 

We have audited the accompanying consolidated balance sheets of Bioject Medical Technologies Inc. and subsidiaries (an Oregon corporation) as of December 31, 2003 and 2002 and the related consolidated statements of operations, shareholders’ equity and cash flows for the year ended December 31, 2003, the nine month transition period ended December 31, 2002 and the year ended March 31, 2002.  These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these financial statements based on our audits.

 

We conducted our audits in accordance with auditing standards generally accepted in the United States of America. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement.  An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.

 

In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of Bioject Medical Technologies, Inc. and subsidiaries as of December 31, 2003 and 2002, and the results of their operations and their cash flows for the year ended December 31, 2003, the nine month transition period ended December 31, 2002 and the year ended March 31, 2002 in conformity with accounting principles generally accepted in the United States of America.

 

 

/s/ KPMG LLP

 

 

Portland, Oregon

January 30, 2004

 

29



 

BIOJECT MEDICAL TECHNOLOGIES INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

 

 

 

December 31,

 

 

 

2003

 

2002

 

ASSETS

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

6,893,686

 

$

8,895,687

 

Short-term marketable securities

 

2,259,424

 

8,404,090

 

 

 

 

 

 

 

Accounts receivable, net of allowance for doubtful accounts of $3,000 and $2,500

 

1,299,979

 

561,940

 

Receivable from related party, current portion

 

74,025

 

74,025

 

Inventories

 

1,387,865

 

1,302,776

 

Other current assets

 

227,243

 

163,548

 

Total current assets

 

12,142,222

 

19,402,066

 

 

 

 

 

 

 

Long-term marketable securities

 

3,086,624

 

5,077,043

 

Receivable from related party

 

 

74,025

 

Restricted funds

 

1,500,000

 

 

Property and equipment, net of accumulated depreciation of $4,173,195 and $3,706,027

 

4,759,671

 

2,897,968

 

Other assets, net

 

979,589

 

782,804

 

Total assets

 

$

22,468,106

 

$

28,233,906

 

 

 

 

 

 

 

LIABILITIES AND SHAREHOLDERS’ EQUITY

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Current portion of long-term debt

 

$

175,000

 

$

 

Accounts payable

 

1,113,923

 

470,321

 

Accrued payroll

 

432,744

 

438,766

 

Other accrued liabilities

 

464,964

 

113,034

 

Deferred revenue

 

434,119

 

67,140

 

Total current liabilities

 

2,620,750

 

1,089,261

 

 

 

 

 

 

 

Long-term liabilities:

 

 

 

 

 

Long-term lease payable

 

81,969

 

26,125

 

Long-term debt

 

1,325,000

 

 

Deferred revenue

 

484,646

 

251,792

 

 

 

 

 

 

 

Commitments

 

 

 

 

 

 

 

 

 

 

 

Shareholders’ equity:

 

 

 

 

 

Preferred stock, no par value, 10,000,000 shares authorized; issued and outstanding:

 

 

 

 

 

Series A Convertible - 952,738 shares at December 31, 2003 and 2002, $15 stated value

 

17,149,000

 

17,149,000

 

Series C Convertible - 391,830 shares at December 31, 2003 and 2002, no stated value

 

2,400,000

 

2,400,000

 

Common stock, no par, 100,000,000 shares authorized; issued and outstanding 10,820,481 and 10,644,887 shares at December 31, 2003 and 2002

 

88,777,145

 

88,355,898

 

Accumulated deficit

 

(90,370,404

)

(81,038,170

)

Total shareholders’ equity

 

17,955,741

 

26,866,728

 

Total liabilities and shareholders’ equity

 

$

22,468,106

 

$

28,233,906

 

 

The accompanying notes are an integral part of these consolidated financial statements.

 

30



 

BIOJECT MEDICAL TECHNOLOGIES INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS

 

 

 

For the
year ended
December 31,
2003

 

For the nine
month transition
period ended
December 31,
2002

 

For the year
ended March 31,
2002

 

 

 

 

 

 

 

 

 

Revenue:

 

 

 

 

 

 

 

Net sales of products

 

$

5,314,256

 

$

2,971,407

 

$

3,235,122

 

Licensing and technology fees

 

1,005,464

 

1,332,194

 

1,983,623

 

 

 

6,319,720

 

4,303,601

 

5,218,745

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

Manufacturing

 

5,181,167

 

3,558,532

 

4,718,202

 

Research and development

 

5,164,338

 

2,842,127

 

2,830,966

 

Selling, general and administrative

 

5,558,269

 

3,871,139

 

4,759,395

 

Total operating expenses

 

15,903,774

 

10,271,798

 

12,308,563

 

Operating loss

 

(9,584,054

)

(5,968,197

)

(7,089,818

)

 

 

 

 

 

 

 

 

Interest income

 

259,862

 

504,911

 

1,211,633

 

Other expense

 

(8,042

)

(2,185

)

(93,014

)

 

 

251,820

 

502,726

 

1,118,619

 

Loss before preferred stock dividend

 

(9,332,234

)

(5,465,471

)

(5,971,199

)

Preferred stock dividend

 

 

 

(2,519,407

)

Net loss allocable to common shareholders

 

$

(9,332,234

)

$

(5,465,471

)

$

(8,490,606

)

 

 

 

 

 

 

 

 

Basic and diluted net loss per common share

 

$

(0.87

)

$

(0.52

)

$

(0.87

)

 

 

 

 

 

 

 

 

Shares used in per share calculations

 

10,719,902

 

10,595,613

 

9,777,801

 

 

The accompanying notes are an integral part of these consolidated financial statements.

 

31



 

BIOJECT MEDICAL TECHNOLOGIES INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY

 

 

 

Preferred Stock

 

Common Stock

 

 

 

Total

 

 

 

Series A

 

Series C

 

Accumulated

 

 

 

Accumulated

 

Shareholders’

 

 

 

Shares

 

Amount

 

Shares

 

Amount

 

Shares

 

Amount

 

Deficit

 

Equity

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at March 31, 2001

 

692,694

 

$

13,453,593

 

391,830

 

$

2,400,000

 

8,144,973

 

$

67,902,703

 

$

(67,082,093

)

$

16,674,203

 

Issuance of common stock pursuant to warrant exercises

 

 

 

 

 

341,331

 

2,436,118

 

 

2,436,118

 

Issuance of common stock pursuant to stock option exercises

 

 

 

 

 

42,506

 

242,971

 

 

242,971

 

Stock issuance in connection with 401(k) and ESPP funding

 

 

 

 

 

24,625

 

131,968

 

 

131,968

 

Issuance of common stock, options and warrants in exchange for services

 

 

 

 

 

39,000

 

496,360

 

 

496,360

 

Issuance of common stock and warrants in a private placement in May and June 2001, net of offering costs

 

 

 

 

 

1,630,000

 

14,575,585

 

 

14,575,585

 

Issuance of common stock and warrants in a private placement in December 2001, net of offering costs

 

 

 

 

 

350,000

 

3,380,013

 

 

3,380,013

 

Modification to terms of Elan’s Series A Preferred Stock and common stock warrants

 

 

2,857,930

 

 

 

 

(1,176,000

)

 

1,681,930

 

Preferred stock dividend

 

260,044

 

837,477

 

 

 

 

 

 

837,477

 

Net loss allocable to common shareholders

 

 

 

 

 

 

 

(8,490,606

)

(8,490,606

)

Balance at March 31, 2002

 

952,738

 

17,149,000

 

391,830

 

2,400,000

 

10,572,435

 

87,989,718

 

(75,572,699

)

31,966,019

 

Issuance of common stock pursuant to stock option exercises

 

 

 

 

 

44

 

179

 

 

179

 

Stock issuance in connection with 401(k) and ESPP funding

 

 

 

 

 

72,408

 

198,158

 

 

198,158

 

Issuance of common stock, options and warrants in exchange for services

 

 

 

 

 

 

167,843

 

 

167,843

 

Net loss allocable to common shareholders

 

 

 

 

 

 

 

(5,465,471

)

(5,465,471

)

Balance at December 31, 2002

 

952,738

 

17,149,000

 

391,830

 

2,400,000

 

10,644,887

 

88,355,898

 

(81,038,170

)

26,866,728

 

Issuance of common stock pursuant to stock option exercises

 

 

 

 

 

10,000

 

20,800

 

 

20,800

 

Stock issuance in connection with 401(k) and ESPP funding

 

 

 

 

 

165,594

 

333,707

 

 

333,707

 

Issuance of common stock, options and warrants in exchange for services

 

 

 

 

 

 

66,740

 

 

66,740

 

Net loss allocable to common shareholders

 

 

 

 

 

 

 

(9,332,234

)

(9,332,234

)

Balance at December 31, 2003

 

952,738

 

$

17,149,000

 

391,830

 

$

2,400,000

 

10,820,481

 

$

88,777,145

 

$

(90,370,404

)

$

17,955,741

 

 

The accompanying notes are an integral part of these consolidated financial statements.

 

32



 

BIOJECT MEDICAL TECHNOLOGIES INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CASH FLOWS

 

 

 

For the
year ended
December 31,
2003

 

For the nine
month transition
period ended
December 31,
2002

 

For the year
ended March 31,
2002

 

Cash flows from operating activities:

 

 

 

 

 

 

 

Net loss allocable to common shareholders

 

$

(9,332,234

)

$

(5,465,471

)

$

(8,490,606

)

Adjustments to reconcile net loss allocable to common shareholders to net cash used in operating activities:

 

 

 

 

 

 

 

Compensation expense related to fair value of stock options

 

66,740

 

42,710

 

60,080

 

Stock contributed to  401(k) Plan

 

144,074

 

55,023

 

23,186

 

Contributed capital for services

 

 

125,133

 

436,280

 

Other non-cash loss, net

 

 

 

88,878

 

Depreciation and amortization

 

533,206

 

335,192

 

397,491

 

Amortization of related party receivable

 

74,025

 

74,025

 

 

Preferred stock dividends

 

 

 

2,519,407

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

Accounts receivable

 

(738,039

)

1,105,029

 

(1,227,160

)

Inventories

 

(85,089

)

158,137

 

(441,312

)

Other current assets

 

(63,695

)

61,890

 

(75,979

)

Related party receivable

 

 

(72,075

)

(150,000

)

Accounts payable

 

629,485

 

(148,209

)

290,950

 

Accrued payroll

 

(6,022

)

85,104

 

82,516

 

Other accrued liabilities

 

351,930

 

(30,134

)

(92,095

)

Deferred revenue

 

599,833

 

(67,275

)

(82,722

)

Net cash used in operating activities

 

(7,825,786

)

(3,740,921

)

(6,661,086

)

 

 

 

 

 

 

 

 

Cash flows from investing activities:

 

 

 

 

 

 

 

Purchase of restricted funds CD

 

(1,500,000

)

 

 

Purchase of marketable securities

 

 

(4,500,000

)

(19,496,797

)

Maturity of marketable securities

 

8,135,085

 

10,363,701

 

8,954,658

 

Purchase of related party property

 

 

 

(601,000

)

Proceeds from sale of related party property

 

 

 

507,986

 

Capital expenditures

 

(2,236,921

)

(838,081

)

(1,953,023

)

Proceeds from sale of capital equipment

 

 

 

1,391

 

Other assets

 

(262,823

)

(134,377

)

(127,331

)

Net cash provided by (used in) investing activities

 

4,135,341

 

4,891,243

 

(12,714,116

)

 

 

 

 

 

 

 

 

Cash flows from financing activities:

 

 

 

 

 

 

 

Proceeds from bank loan

 

1,500,000

 

 

 

Payments made on capital lease obligations

 

(21,989

)

(10,715

)

(10,045

)

Cash proceeds from the sale of common stock

 

210,433

 

143,314

 

20,743,469

 

Net cash provided by financing activities

 

1,688,444

 

132,599

 

20,733,424

 

 

 

 

 

 

 

 

 

Increase (decrease) in cash and cash equivalents

 

(2,002,001

)

1,282,921

 

1,358,222

 

 

 

 

 

 

 

 

 

Cash and cash equivalents:

 

 

 

 

 

 

 

Beginning of period

 

8,895,687

 

7,612,766

 

6,254,544

 

End of period

 

$

6,893,686

 

$

8,895,687

 

$

7,612,766

 

 

 

 

 

 

 

 

 

Supplemental disclosure of cash flow information:

 

 

 

 

 

 

 

Equipment purchased with capital lease

 

$

91,950

 

$

34,995

 

$

 

Equipment received in exchange for forgiveness of note

 

 

 

20,000

 

Note receivable forgiven in exchange for property received

 

 

 

15,864

 

Modification to terms of Elan’s Series A Preferred Stock and common stock warrants

 

 

 

2,857,930

 

 

The accompanying notes are an integral part of these consolidated financial statements.

 

33



 

BIOJECT MEDICAL TECHNOLOGIES INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

 

1.   THE COMPANY:

 

General

The consolidated  financial statements of Bioject Medical Technologies Inc. include the accounts of Bioject Medical Technologies Inc., an Oregon corporation, and its wholly owned subsidiaries. All significant intercompany transactions have been eliminated.

 

We commenced operations in 1985 for the purpose of developing, manufacturing and distributing needle-free drug delivery systems. Since our formation, we have been engaged principally in organizational, financing, research and development, and marketing activities.  Since inception, we have incurred operating losses and, at December 31, 2003, had an accumulated deficit of approximately $90 million.  Our revenues to date have been derived primarily from licensing and technology fees for the jet injection technology and from product sales of the B-2000 and spring-powered Vitajet® devices and syringes.

 

Change in Fiscal Year

During 2002, we changed our fiscal year from a March 31 year end to a December 31 year end.

 

Factors That May Affect Future Results of Operations

Future revenues will depend upon acceptance and use by healthcare providers and on our successfully entering into license, development and supply agreements with major pharmaceutical and biotechnology companies. Uncertainties over government regulation and competition in the healthcare industry may impact healthcare provider expenditures and third party payer reimbursements and, accordingly, we cannot predict what impact, if any, subsequent healthcare reforms and industry trends might have on our business.  In the future, we are likely to require substantial additional financing. Failure to obtain such financing on favorable terms could adversely affect our business.

 

To date, our revenues have not been sufficient to cover manufacturing and operating expenses.  However, we believe that if our products attain significantly greater general market acceptance and if we are able to enter into large volume supply agreements with major pharmaceutical and biotechnology companies, our product sales volume will increase. Significantly higher product sales volumes will allow us to realize volume-related manufacturing cost efficiencies.  This, in turn, will result in a reduced costs of goods as a percentage of sales, eventually allowing us to achieve positive gross profit.  We believe that positive gross profit from product sales, together with licensing and technology revenues from agreements entered into with large pharmaceutical and biotechnology companies will eventually allow us to operate profitably as we leverage our research and development and selling, general and administrative expenses.

 

The level of revenues required to generate net income will be affected by a number of factors including the mix of revenues between product sales and licensing and technology fees, pricing of the our products, our ability to attain volume-related and automation-related manufacturing efficiencies and the impact of inflation on our manufacturing and other operating costs. There can be no assurance that we will achieve sufficient cost reductions or sell our products at prices or in volumes sufficient to achieve profitability or offset increases in our costs should they occur.

 

34



 

2.   SIGNIFICANT ACCOUNTING POLICIES:

 

Cash Equivalents and Marketable Securities

Cash equivalents consist of highly liquid investments with maturities at the date of purchase of 90 days or less.  We had $6.9 million and $8.9 million of cash and cash equivalents as of December 31, 2003 and 2002, respectively.

 

We account for our marketable securities in accordance with SFAS No. 115, “Accounting for Certain Investments in Debt and Equity Securities.”  Accordingly, our securities, which are all considered held to maturity, are recorded at amortized cost adjusted for the amortization of premiums or discounts. Marketable securities consist primarily of government and corporate debt instruments, which are classified as “held to maturity.”  See Note 4.

 

Restricted Funds

Restricted funds of $1.5 million at December 31, 2003, which have been invested in a certificate of deposit, represent collateral for our $1.5 million loan outstanding, which is due May 31, 2004.

 

Accounts Receivable

Accounts receivable are recorded at the invoiced amount and do not bear interest. The allowance for doubtful accounts is our best estimate of the amount of probable credit losses in our existing accounts receivable. We do not have any off-balance sheet credit exposure related to our customers.

 

Inventories

Inventories are stated at the lower of cost or market.  Cost is determined in a manner which approximates the first-in, first out (FIFO) method. Costs utilized for inventory valuation purposes include labor, materials and manufacturing overhead.  Net inventories consist of the following:

 

 

 

December 31,

 

 

 

2003

 

2002

 

Raw materials and components

 

$

677,390

 

$

616,800

 

Work in process

 

80,991

 

53,460

 

Finished goods

 

629,484

 

632,516

 

 

 

$

1,387,865

 

$

1,302,776

 

 

Property and Equipment

Property and equipment are stated at cost.  Expenditures for repairs and maintenance are expensed as incurred.  Expenditures that increase the useful life or value are capitalized. For financial statement purposes, depreciation expense on property and equipment is computed on the straight-line method using the following lives:

 

Buildings

 

40 years

 

Furniture and Fixtures

 

5 years

 

Machinery and Equipment

 

7 years

 

Computer Equipment

 

3 years

 

Production Molds

 

5 years

 

 

Leasehold improvements are amortized on the straight-line method over the shorter of the remaining term of the related lease or the estimated useful lives of the assets.

 

Other Assets

Other assets primarily include goodwill and costs incurred in the patent application process.  Pursuant to Statement of Financial Accounting Standards (“SFAS”) No. 142, “Goodwill and Other Intangible Assets,” goodwill and other identifiable intangible assets with indefinite useful lives are no longer amortized, but, instead, tested for impairment, at least annually, in accordance with the provisions of SFAS No. 142.  Patent costs are amortized on a straight-line basis over the expected life of the patent, not to exceed the statutory life of 17 or 20 years. We tested our goodwill for impairment by determining the fair value of the reporting unit and comparing it to its carrying amount and determined

 

35



 

that there was no impairment.  Our patents were reviewed for impairment as discussed below in “Accounting for Long-Lived Assets.”

 

Accounting for Long-Lived Assets

Our long-lived assets include property, plant and equipment and patents.  We account for and review our long-lived assets in accordance with SFAS No. 144, “Accounting for the Impairment or Disposal of Long-Lived Assets,” which requires us to review our long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset might not be recoverable, utilizing an undiscounted cash flow analysis.  If the carrying amount of an asset exceeds its estimated future cash flows, an impairment charge is only recognized to the extent the carrying amount exceeds the fair value of the asset. We did not recognize an impairment on our long-lived assets during the year ended December 31, 2003, the nine months ended December 31, 2002 or the year ended March 31, 2002.

 
Fair Value of Financial Assets and Liabilities

We estimate the fair value of our monetary assets and liabilities, including, but not limited to, accounts receivable, accounts payable and debt, based upon comparison of such assets and liabilities to the current market values for instruments of a similar nature and degree of risk. We estimate that the recorded value of all our monetary assets and liabilities approximates fair value as of December 31, 2003 and 2002.

 

Revenue Recognition

 

Product Sales and Concentrations

We record revenue from sales of our products upon delivery, which is when title and risk of loss have passed to the customer.  In the year ended December 31, 2003, two customers accounted for approximately 38% and 34%, respectively, of product sales.  In the nine months ended December 31, 2002, one customer accounted for 59% of net product sales.  In the year ended March 31, 2002, one customer accounted for 65% of net product sales.  At December 31, 2003 and 2002, accounts receivable from one customer accounted for 83% and 71% of total accounts receivable, respectively.

 

License and  Development Fees

In accordance with Staff Accounting Bulletin 104 (“SAB 104”), “Revenue Recognition,” product development revenue is recognized on a percentage of completion basis as qualifying expenditures are incurred and licensing revenues, if separable, are recognized over the term of the license agreement.  The FASB’s Emerging Issues Task Force (EITF) finalized EITF 00-21 “Accounting for Multiple Element Arrangements” in November 2002. EITF 00-21 requires arrangements with multiple elements to be broken out as separate units of accounting based on their relative fair values.  Revenue for a separate unit of accounting should be recognized only if the amount due can be reliably measured and the earnings process is substantially complete.  Any units that can not be separated must be accounted for as a combined unit.  Our accounting policy is consistent with EITF 00-21. Should agreements be terminated prior to completion or our estimates of percentage of completion be incorrect, we could have unanticipated fluctuations in our revenue on a quarterly basis. Amounts received prior to meeting recognition criteria are recorded on our balance sheet as deferred revenues and are recognized according to the terms of the associated agreements. At December 31, 2003, deferred revenues totaled $919,000 and include amounts received from Serono, Merial and other potential licensing partners.

 

36



 

Current significant product supply and licensing and technology development agreements are summarized as follows:

 

Serono

In December 1999, Bioject and Serono Laboratories, Inc. (“Serono”), the U.S. affiliate of Serono, S.A., a leading biotechnology company headquartered in Geneva, Switzerland, announced an exclusive license agreement in the U.S. and Canada to deliver Serono’s Saizen® recombinant human growth hormone with a customized version of Bioject’s Vitajet® needle-free delivery system, the cool.click™.  In connection with the agreement, Serono paid a license fee to Bioject and signed a definitive supply agreement that commenced upon FDA clearance.  No technology development fees were required under the agreement.  The license fee is being recognized over the term of the agreement.

 

During the third quarter of the fiscal year ended March 31, 2001, we amended our agreement with Serono to provide Serono with exclusive worldwide distribution rights for its Saizen® recombinant human growth hormone using the cool.click™.   In addition, Serono was given exclusive worldwide rights to use a customized version of the Vitajet®, the SeroJet™, for AIDS wasting applications.  In exchange for the exclusive worldwide licenses, we received licensing fees, which are being recognized over the term of the agreement.  At December 31, 2003 and 2002, deferred revenue related to Serono was $251,786 and $318,929, respectively.

 

Alkermes, Inc.

In October 2001, we signed a license and technology development agreement with Alkermes, Inc. to develop up to three undisclosed drug compounds as proprietary products using the Iject® needle-free drug delivery system.  The agreement originally provided for $3.5 million in license and development fees to be paid beginning in the third quarter of the fiscal year ended March 31, 2002. The agreement was amended in August 2002 to defer progress payments for the remaining $3.4 million in development fees to the second quarter of 2003.  In 2003, Alkermes indefinitely postponed the original project and there has been minimal activity associated with the agreement. The development fees are being recognized as revenue on the percentage of completion method over the development period.  Revenue recognized is limited to cash payments received to date and receivable for milestones achieved. Any additional drugs will have separately negotiated terms.  Revenue recognized to date through December 31, 2003 is $190,000.

 

Merial

In August 2002, we entered into an exclusive license and supply agreement with Merial, the world’s leading animal health company, for delivery of Merial’s veterinary pharmaceuticals and vaccines utilizing a veterinary focused needle-free injector system, the Vetjet™, which is currently in development. Merial will initially focus on delivery of vaccines to food-production animals. The agreement provides for monthly payments to Bioject for product development, with additional payments at key product development and regulatory milestones.  Revenue will be recognized on the percentage of completion method over the development period as costs are incurred with a limitation based on cash payments received to date and receivables for milestones achieved.  We will also receive royalty payments on Merial’s vaccine sales, if and when they occur, which utilize the needle-free injector system.  Any additional indications or drugs will have separately negotiated terms.  We recognized revenue of $500,000 and $850,000 pursuant to this agreement in 2003 and 2002, respectively.

 

National Institutes of Health

In June 2003, we signed a subcontract with SAIC-Frederick, Inc., a subsidiary of Science Applications International Corporation – Frederick (SAIC). Under SAIC’s contract with the National Cancer Institute, the federal government is utilizing our Biojector® 2000 needle-free technology in HIV and Ebola clinical trials.  Pursuant to the subcontract, we will supply the government’s Vaccine Research Center, National Institute of Allergy and Infectious Diseases/National Institutes of Health with non-exclusive rights to utilize our B-2000 needle-free injection system for up to a 36-month period.  In addition, we will provide product training, clinical and administrative support for the clinical trials.  We expect that under the subcontract we will be reimbursed by SAIC-Frederick, Inc. on a time and material basis up

 

37



 

to $250,000 per year for product supplied and services performed.  We recognized revenue of $50,000 related to this agreement in 2003.

 

Research and Development

Expenditures for research and development are charged to expense as incurred.

 

Income Taxes

We account for income taxes in accordance with SFAS No. 109, “Accounting for Income Taxes.”   Under the asset and liability method specified by SFAS No. 109, deferred tax assets and liabilities are recognized for the future consequences of differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases (temporary differences).  Deferred tax assets and liabilities are measured using tax rates expected to apply to taxable income in the years in which those temporary differences are recovered or settled.  Valuation allowances for deferred tax assets are established when it is more likely than not that some portion or all of the deferred tax assets will not be realized.

 

Use of Estimates

The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period.  Significant items subject to such estimates and assumptions include the carrying amount of property and equipment and valuation allowances for receivables, inventory and deferred income taxes. Actual results could differ from those estimates.

 

Product Warranty

We have a one-year warranty policy for defective products with options to purchase extended warranties for additional years for our B-2000 product line and an 18-month warranty policy for the cool.click™ and SeroJet™. We review our accrued warranty on a quarterly basis utilizing recent return rates and sales levels. The estimated warranty is recorded as a reduction of product sales and is reflected on the accompanying consolidated balance sheet in other accrued liabilities.  Our warranty accrual totaled $31,000 at both December 31, 2003 and 2002 and there was no significant activity in the warranty accrual.

 

Comprehensive Income Reporting

SFAS No. 130, “Reporting  Comprehensive  Income” establishes standards for reporting and displaying comprehensive income and its components in a full set of general purpose financial statements. The objective of SFAS No. 130 is to report a measure of all changes in the equity of an enterprise that result from transactions and other economic events of the period other than transactions with owners.  Comprehensive loss did not differ from currently reported net loss in the periods presented.

 

Net Loss Per Share

Basic loss per common share is computed using the weighted average number of shares of common stock outstanding for the period. Diluted loss per common share is computed using the weighted average number of shares of common stock and dilutive common equivalent shares outstanding during the year. Common equivalent shares from stock options and other common stock equivalents are excluded from the computation when their effect is antidilutive.

 

We were in a loss position for all periods presented and, accordingly  there is no difference between basic loss per share and diluted loss per share since the common stock equivalents and the effect of convertible preferred stock under the “if-converted” method would be antidilutive.

 

38



 

Potentially dilutive securities that were not included in the diluted net loss per share calculations because they would be antidilutive are as follows:

 

 

 

Year Ended
December 31,
2003

 

Nine Months
Ended
December 31,
2002

 

Year Ended
March 31,
2002

 

Stock options and warrants

 

3,901,943

 

3,540,159

 

3,073,133

 

Convertible preferred stock

 

2,689,136

 

2,689,136

 

2,689,136

 

Total

 

6,591,079

 

6,229,295

 

5,762,269

 

 

Stock Based Compensation

We apply the intrinsic-value-based method of accounting prescribed by Accounting Principles Board (APB) Opinion No. 25, “Accounting for Stock Issued to Employees,” and related interpretations including FASB Interpretation No. 44, “Accounting for Certain Transactions Involving Stock Compensation, an Interpretation of APB Opinion No. 25,” to account for our fixed-plan stock options.  Under this method, compensation expense is recorded on the date of grant only if the current market price of the underlying stock exceeded the exercise price.  FASB Statement No. 123 “Accounting for Stock-Based Compensation” and FASB Statement No. 148, “Accounting for Stock-Based Compensation – Transition and Disclosure, an amendment of FASB Statement No. 123,” established accounting and disclosure requirements using a fair-value-based method of accounting described above, and has adopted only the disclosure requirements of SFAS No. 123, as amended.  The following table illustrates the effect on net loss and net loss per share if the fair-value-based method had been applied to all outstanding and unvested awards in each period.

 

(In thousands, except per share amounts)

 

Year Ended
December 31,
2003

 

Nine Months
Ended
December 31,
2002

 

Year
Ended
March 31,
2002

 

Net loss allocable to common shareholders, as reported

 

$

(9,332

)

$

(5,465

)

$

(8,491

)

Add - stock-based employee compensation expense included in reported net loss

 

16

 

 

 

Deduct - total stock-based employee compensation expense determined under the fair value based method for all awards not previously included in net loss

 

(2,779

)

(3,385

)

(3,372

)

Net loss allocable to common shareholders, pro forma

 

$

(12,095

)

$

(8,850

)

$

(11,863

)

Basic and diluted net loss per share:

 

 

 

 

 

 

 

As reported

 

$

(0.87

)

$

(0.52

)

$

(0.87

)

Pro forma

 

$

(1.13

)

$

(0.84

)

$

(1.21

)

 

The above determination of pro forma expense has been calculated consistent with SFAS No. 123, which does not take into consideration limitations on exercisability and transferability imposed by our 1992 Stock Incentive Plan. Further, the valuation model is heavily weighted to stock price volatility, even with a declining stock price, which tends to increase the calculated value.  No stock-based employee compensation is included in net loss for any of the periods presented since all of the options were granted at the fair market value of our common stock on the date of grant.

 

We used the Black-Scholes option pricing model and the following weighted average assumptions in calculating the value of all options granted during the periods presented:

 

 

 

Year Ended
December 31,
2003

 

Nine Months
Ended
December 31,
2002

 

Year
Ended
March 31,
2002

 

Risk-free interest rate

 

3.0

%

3.0

%

4.0

%

Expected dividend yield

 

0

%

0

%

0

%

Expected lives

 

5 years

 

5 years

 

3 years

 

Volatility

 

93

%

114

%

122

%

 

The total fair value of options granted during the year ended December 31, 2003, the nine months ended December 31, 2002 and the year ended March 31, 2002 totaled $1.3 million, $1.2 million and

 

39



 

$5.9 million, respectively, and is amortized on a pro forma basis over the vesting period of the options. The average per share fair value of options granted in the year ended December 31, 2003, the nine months ended December 31, 2002 and the year ended March 31, 2002 was $2.65, $1.70 and $6.19, respectively.  Options generally vest equally over three years.

 

Reclassifications

Certain reclassifications have been made to the consolidated financial statements for the nine month transition period ended December 31, 2002 and the year ended March 31, 2002 in order to conform to the 2003 presentation.

 

3.   AGREEMENTS WITH ELAN CORPORATION:

 

In June 1999, we sold our blood glucose monitoring technology company, Marathon Medical Technologies Inc., which we owned with Elan. The terms of the sale provide for us to receive a royalty on net sales of future products, if any, which may be developed in the future from the licensed technology. The agreement calls for a royalty of three percent of net sales until we have received total royalty payments of $10 million. The agreement then calls for a royalty of one percent of net sales thereafter.  We have not received any royalties under this agreement and there can be no assurance that any future products will be successfully developed from the blood glucose monitoring technology or that such products, if developed, will be commercially successful.

 

In October 2001, we announced our intention to redeem 24% of the outstanding shares of our Series A Preferred Stock, which is held by Elan.  Elan disputed our right to redeem such shares at that time.  To enforce our redemption rights, we filed a lawsuit in U.S. District Court in Oregon seeking an injunction and declaratory judgment to compel Elan to abide by the redemption provisions in our Articles of Incorporation.  Subsequently, we received notice from Elan of its intention to convert all of its shares of Series A Preferred Stock into shares of our common stock.  As a result of Elan’s notice of intent to convert the Series A Preferred Stock, we had the right under our Articles of Incorporation and agreements with Elan to redeem all of the Series A Preferred Stock for an aggregate redemption price of $14.5 million.  We had until January 8, 2002 to exercise this right.

 

On December 12, 2001, we came to an agreement with Elan wherein Elan agreed to the following:

                  to eliminate, on a prospective basis from October 15, 2001, the 9% cumulative annual dividend payable on the Series A Preferred Stock;

                  to terminate its Series K common stock warrants which gave Elan the right to purchase 350,000 shares of Bioject common stock at $12.50 per share; and

                  to partially exercise its Series P warrant to purchase 252,666 shares of Bioject common stock for $7.50 per share or a total of $1.9 million.

 

In exchange, we agreed to the following:

                  to issue to Elan an additional 260,044 shares of Series A Preferred Stock in full satisfaction of our obligations with respect to dividends accrued on the Series A Preferred Stock through October 15, 2001;

                  to eliminate all of our rights to redeem shares of Series A Preferred Stock, particularly including the right that we had proposed to exercise to override Elan’s Series A conversion rights by redeeming shares of Series A Preferred Stock as to which Elan had given notice of intent to convert;

                  to eliminate provisions that required the mandatory conversion of all outstanding shares of Series A Preferred Stock on October 15, 2004; and

                  to dismiss the lawsuit we had filed to enforce our Series A redemption rights.

 

In connection with the termination of the Series K warrant and the changes to the Series A Preferred Stock, we recorded an additional preferred dividend charge of  $1.7 million in the third quarter of the year ended March 31, 2002, which resulted in total preferred dividends in that quarter of $1.9 million.  The preferred dividend charge reflects a non-cash accounting adjustment required under generally

 

40



 

accepted accounting principles to record the fair market value of the Series A Preferred Stock after giving effect to modifications of the terms under the Elan agreement.

 

See Note 16 Subsequent Event for a discussion of events related to Elan subsequent to December 31, 2003.

 

4.   MARKETABLE SECURITIES:

 

Certain information regarding our marketable securities is as follows:

 

 

 

December 31,

 

Held to Maturity

 

2003

 

2002

 

Fair Market Value

 

$

5,360,171

 

$

13,533,132

 

Amortized Cost:

 

 

 

 

 

Federal Government

 

$

3,988,836

 

$

7,488,157

 

Corporate

 

1,357,212

 

5,992,976

 

Total

 

$

5,346,048

 

$

13,481,133

 

Maturity Information:

 

 

 

 

 

Less than one year

 

$

2,259,424

 

$

8,404,090

 

One to three years

 

3,086,624

 

5,077,043

 

Total

 

$

5,346,048

 

$

13,481,133

 

 

5.   PROPERTY, PLANT AND EQUIPMENT:

 

Property, plant and equipment consisted of the following:

 

 

 

December 31,

 

 

 

2003

 

2002

 

Land and building

 

$

1,409,016

 

$

1,409,016

 

Machinery and equipment

 

3,719,259

 

2,916,614

 

Production molds

 

1,844,931

 

1,435,430

 

Furniture and fixtures

 

446,860

 

385,139

 

Leasehold improvements

 

157,130

 

95,213

 

Assets in process

 

1,355,670

 

362,583

 

 

 

8,932,866

 

6,603,995

 

Less – accumulated depreciation

 

(4,173,195

)

(3,706,027

)

 

 

$

4,759,671

 

$

2,897,968

 

 

6.   INTANGIBLE ASSETS

 

Included in other long-term assets on our balance sheet are goodwill and patents.  There were no changes to our goodwill balance in 2003 or 2002.  Amortization expense for goodwill was not significant for the year ended March 31, 2002. The gross amount of goodwill and the gross amount of patents and the related accumulated amortization were as follows:

 

 

 

December 31,

 

 

 

2003

 

2002

 

Goodwill

 

$

94,074

 

$

94,074

 

 

 

 

 

 

 

Patents

 

1,299,846

 

1,037,023

 

Accumulated amortization

 

(414,331

)

(348,293

)

 

 

885,515

 

688,730

 

 

 

$

979,589

 

$

782,804

 

 

41



 

Amortization expense was as follows:

 

 

 

Year Ended
December 31,
2003

 

Nine Months
Ended
December 31,
2002

 

Year Ended
March 31,
2002

 

Patents

 

$

66,038

 

$

41,016

 

$

47,292

 

 

Amortization of the patents is as follows over the next five years:

 

Year Ending December 31,

 

 

 

2004

 

$

84,000

 

2005

 

88,000

 

2006

 

98,000

 

2007

 

98,000

 

2008

 

95,000

 

 

7.   401(K) RETIREMENT BENEFIT PLAN:

 

We have a 401(k) Retirement Benefit Plan for our employees.  All employees, subject to certain age and length of service requirements, are eligible to participate. The plan permits certain voluntary employee contributions to be excluded from the employees’ current taxable income under provisions of the Internal Revenue Code Section 401(k).  We match 50% of employee contributions up to 6% of salary with our common stock and may make discretionary profit sharing contributions to all employees, which may either be made in cash or common stock.  Currently, participant’s are not allowed to sell our common stock held in their account until their participation in the 401(k) plan is terminated.  Based on changing legislation, we are considering allowing for sales of our common stock in the future. For the year ended December 31, 2003, the nine months ended December 31, 2002 and the year ended March 31, 2002, we recorded an expense of $100,000, $81,000 and $55,000, respectively, related to employer matches of our stock under the 401(k) Plan. The Board of Directors has reserved up to 160,000 shares of common stock for these voluntary employer matches, of which 108,410 shares have been issued and an additional 7,120 shares were committed to be issued at December 31, 2003.

 

8.   INCOME TAXES:

 

We had the following deferred tax assets and (liabilities):

 

 

 

December 31,

 

 

 

2003

 

2002

 

Inventory

 

$

653,252

 

$

441,746

 

Deferred revenue

 

349,131

 

121,194

 

Other accrued liabilities

 

136,808

 

96,011

 

Depreciation and amortization

 

(538,969

)

(253,612

)

Net operating loss carryforwards and credits

 

34,293,894

 

31,056,362

 

Total deferred tax assets

 

34,894,116

 

31,461,701

 

Less valuation allowance

 

(34,894,116

)

(31,461,701

)

Net deferred tax assets

 

$

 

$

 

 

A full valuation allowance has been recorded against the deferred tax assets because of the uncertainty regarding the realizability of these benefits due to our historical operating losses. The net change in the valuation allowance for deferred tax assets was an increase of $3,432,415, $1,952,210 and $800,000 for the year ended December 31, 2003, the nine months ended December 31, 2002 and the year ended March 31, 2002, respectively, mainly due to the increase in net operating loss carry forwards.  As of December 31, 2003, we had net operating loss carry forwards of approximately $88.2 million available to reduce future federal and state taxable income, which expire in 2004 through 2023. Approximately $1.1 million of our carry forwards were generated as a result of deductions

 

42



 

related to exercises of stock options. When utilized, this portion of our carry forwards, as tax effected, will be accounted for as a direct increase to contributed capital rather than as a reduction of that year’s provision for income taxes.

 

9.   LONG-TERM DEBT:

 

In November 2003, we entered into a $1.5 million loan agreement with U.S. Bank for the purpose of purchasing capital equipment, which bears interest at the prime rate (4.0% at December 31, 2003) and is due May 31, 2004.  At December 31, 2003, $1.5 million was outstanding under this agreement and we had a $1.5 million certificate of deposit collateralizing the loan amount.  We also have a financing commitment from U.S. Bank to convert the $1.5 million loan to a five-year term loan bearing interest at U.S. Bank’s cost-of-funds rate plus 2.25% prior to May 31, 2004.  At December 31, 2003, this rate would have been 5.20%.  Interest payments are due monthly.  As a result, this amount is reflected in long-term debt. Principal payments called for by the committed 5-year term loan are as follows:

 

Year Ending December 31,

 

 

 

2004

 

$

175,000

 

2005

 

300,000

 

2006

 

300,000

 

2007

 

300,000

 

2008

 

300,000

 

Thereafter

 

125,000

 

 

10.   SHAREHOLDERS’ EQUITY:

 

Shareholder Rights Plan

On July 1, 2002, we adopted a shareholder rights agreement in order to obtain maximum value for shareholders in the event of an unsolicited acquisition attempt.  To implement the agreement, Bioject issued a dividend of one right for each share of its common stock held by shareholders of record as of the close of business on July 19, 2002.

 

Each right initially entitles shareholders to purchase a fractional share of our preferred stock for $50.00.  However, the rights are not immediately exercisable and will become exercisable only if certain events related to an unsolicited acquisition attempt occur. For example, unless earlier redeemed for $0.001 per right, when a person or group acquires 15% or more of our common stock (or 20% in the case of Mazama Capital Management, Inc.), all rights holders (except the person or group who acquired the triggering amount of shares) will be able to exercise their rights for our shares having a value of twice the right’s then-current exercise price.

 

Preferred Stock

We have authorized 10 million shares of preferred stock to be issued from time to time with such designations and preferences and other special rights and qualifications, limitations and restrictions thereon, as permitted by law and as fixed from time to time by resolution of the Board of Directors.  At December 31, 2003, we had preferred stock authorized and outstanding as follows (see also Notes 3 and 16):

 

Series A Convertible Preferred Stock

Our Series A Convertible Preferred Stock (“Series A Stock”) is held by Elan Pharmaceuticals Investments, Ltd. (“Elan”). The terms of the Series A Stock were modified in December 2001 to:

                  eliminate the 9% cumulative annual dividend after October 15, 2001;

                  eliminate the mandatory redemption provisions as well as all other redemption rights that we previously had; and

                  eliminate the automatic conversion provision.

 

43



 

The Series A Stock has preference in liquidation to our common stock.  A total of 952,738 shares of Series A Stock were outstanding at December 31, 2003, which are convertible, at any time upon Elan’s election, on a 2-for-1 basis into a total of 1,905,476 shares of our common stock (see also Note 16).

 

Series C Convertible Preferred Stock

Our Series C Convertible Preferred Stock (“Series C Stock”) is also held by Elan.  The Series C Stock has preference in liquidation to our common stock.  A total of 391,830 shares of Series C Stock were outstanding at December 31, 2003, which are convertible, at any time upon Elan’s election, on a 2-for-1 basis into a total of 783,660 shares of our common stock (see also Note 16).

 

Common Stock

Holders of common stock are entitled to one vote for each share held on all matters to be voted on by shareholders.  No shares have been issued subject to assessment, and there are no preemptive or conversion rights and no provision for redemption, purchase or cancellation, surrender or sinking or purchase funds.  Holders of common stock are not entitled to cumulate their shares in the election of directors.  Certain holders of common stock have certain demand and piggyback registration rights enabling them to register their shares for sale under the 1933 Securities Act.

 

In the future, we may incur a non-cash charge to compensation expense in connection with the issuance of 20,000 shares of our common stock to our Chief Executive Officer.  Under terms of his employment agreement, he will receive the shares of common stock when we first achieve two consecutive quarters of positive earnings per share.  Upon issuance of such shares, we will record a non-cash charge to compensation expense at the fair market value of the stock on the last day of the quarter in which the shares are earned.

 

Stock Plans

 

1992 Stock Incentive Plan

Options may be granted to our directors, officers and employees by the Board of Directors under terms of the Bioject Medical Technologies Inc. 1992 Stock Incentive Plan (the “Plan”). Under the terms of the Plan, eligible employees may receive statutory and nonstatutory stock options, stock bonuses and stock appreciation rights for purchase of shares of our common stock at prices and vesting as determined by a committee of the Board.  As amended, a total of up to 3,900,000 shares of our common stock, including options outstanding at the date of initial shareholder approval of the Plan, may be granted under the Plan, as amended.  At December 31, 2003, we had options covering 846,178 shares of our common stock available for grant and a total of 3,563,574 shares of common stock reserved for issuance.  Stock option activity is summarized as follows:

 

 

 

Shares
Subject to
Options

 

Weighted
Average
Exercise Price
Per Share

 

Balances, March 31, 2001

 

1,023,241

 

$

7.27

 

Options granted

 

927,993

 

8.58

 

Options exercised

 

(42,506

)

5.72

 

Options cancelled or expired

 

(115,178

)

10.93

 

Balances, March 31, 2002

 

1,793,550

 

7.75

 

Options granted

 

594,015

 

2.48

 

Options exercised

 

(44

)

4.07

 

Options cancelled or expired

 

(45,897

)

5.97

 

Balances, December 31, 2002

 

2,341,624

 

6.45

 

Options granted

 

471,975

 

3.62

 

Options exercised

 

(10,000

)

2.08

 

Options cancelled or expired

 

(86,203

)

6.70

 

Balances, December 31, 2003

 

2,717,396

 

$

5.96

 

 

44



 

The following table summarizes information about stock options outstanding at December 31, 2003:

 

Options Outstanding

 

Options Exercisable

 

Range of
Exercise
Prices

 

Number

 

Weighted
Average
Remaining
Contractual
Life (years)

 

Weighted
Average
Exercise
Price

 

Number of
Shares
Exercisable

 

Weighted
Average
Exercise
Price

 

$ 1.90 – 3. 45

 

 

825,831

 

4.78

 

$

2.55

 

449,151

 

$

2.79

 

3.51 – 5.69

 

 

990,381

 

4.93

 

4.19

 

449,336

 

4.13

 

6.25 – 10.98

 

 

358,534

 

4.38

 

9.73

 

259,613

 

9.60

 

11.05 – 13.26

 

 

542,650

 

4.45

 

11.91

 

409,812

 

11.99

 

$ 1.90 – 13.26

 

 

2,717,396

 

4.69

 

$

5.96

 

1,567,912

 

$

6.71

 

 

At December 31, 2002 and March 31, 2002, 866,139 and 636,115 options, respectively, were exercisable at weighted average exercise prices of $7.17 per share and $6.16 per share, respectively.

 

Employee Stock Purchase Plan

Our 2000 Employee Stock Purchase Plan, as amended (the “ESPP”), allows for the issuance of 450,000 shares of common stock thereunder.  The ESPP is intended to qualify as an “Employee Stock Purchase Plan” under Section 423 of the Internal Revenue Code of 1986, as amended, and is administered by the Board of Directors.  The purchase price for shares purchased under the ESPP is 85 percent of the lesser of the fair market value at the beginning or end of the purchase period.  At December 31, 2003, we had 260,353 shares remaining available for purchase under the ESPP.  The following shares were purchased under the ESPP:

 

 

 

Shares
Purchased

 

Average
Price

 

Year Ended December 31, 2003

 

105,666

 

$

1.79

 

Nine Months Ended December 31, 2002

 

63,330

 

$

2.26

 

Year Ended March 31, 2002

 

20,651

 

$

5.27

 

 

Warrants

Warrant activity is summarized as follows:

 

 

 

Shares

 

Exercise Price

 

Amount

 

Balances, March 31, 2001

 

1,475,274

 

$2.80 - 12.50

 

$

12,312,236

 

Warrants issued in connection with equity transactions, expiring 2006

 

470,640

 

11.00 - 13.50

 

5,348,493

 

Warrants issued for services, expiring May and November 2004

 

20,000

 

6.45

 

129,000

 

Warrants issued for services, expiring August 2006

 

5,000

 

10.34

 

51,700

 

Warrants terminated in connection with modifications to the Elan agreement

 

(350,000

)

12.50

 

(4,375,000

)

Warrant exercised by Elan

 

(252,666

)

7.50

 

(1,894,995

)

Other warrants exercised

 

(88,665

)

4.14 - 11.00

 

(541,123

)

Balances, March 31, 2002

 

1,279,583

 

2.80-13.50

 

11,030,311

 

Warrants issued for services, expiring May 2005

 

15,000

 

4.85

 

72,750

 

Warrants cancelled or expired

 

(96,048

)

5.00 - 5.50

 

(508,270

)

Balances, December 31, 2002

 

1,198,535

 

2.80-13.50

 

10,594,791

 

Warrants cancelled or expired

 

(13,988

)

6.45-6.74

 

(91,379

)

Balances, December 31, 2003

 

1,184,547

 

$2.80-13.50

 

$

10,503,412

 

 

45



 

11.   COMMITMENTS:

 

Leases

In October 2003, we entered into a 10-year facility lease for new space to house our Portland, Oregon based research and development, manufacturing and administration functions. This lease has one, five-year renewal option.  We anticipate vacating our current space and occupying the new space in April 2004. Our current facility lease expires June 30, 2004.  We lease our Portland, Oregon warehouse facilities pursuant to a lease that expires in September 2004, with an option to renew for an additional five-year term. We do not intend to renew this lease. We also lease office equipment under operating leases for periods up to five years and certain equipment under capital leases. At December 31, 2003, future minimum payments under noncancellable operating and capital leases with terms in excess of one year were as follows:

 

For the year ending December 31,

 

Operating

 

Capital

 

2004

 

$

191,613

 

$

40,656

 

2005

 

341,068

 

40,656

 

2006

 

346,387

 

34,216

 

2007

 

353,984

 

16,770

 

2008

 

362,835

 

7,110

 

Thereafter

 

2,446,056

 

 

Total minimum lease payments

 

$

4,041,943

 

139,408

 

Less amounts representing interest

 

 

 

(27,788

)

Present value of future minimum lease payments

 

 

 

$

111,620

 

 

Lease expense for the year ended December 31, 2003, the nine months ended December 31, 2002 and the year ended March 31, 2002 totaled $259,000, $188,000 and $241,000, respectively.

 

12.  RELATED PARTY TRANSACTIONS:

 

In 2002, we loaned $222,000 to Mr. James O’Shea, our Chief Executive Officer, in order to assist him with his relocation from Oregon to New Jersey.  The note is non-interest bearing and is being forgiven in $74,000 increments in each of January 2003, 2004 and 2005, so long as Mr. O’Shea remains the Company’s Chief Executive Officer.

 

In October 2001, we committed to purchase Mr. O’Shea’s residence in Oregon for $601,000 if not sold by January 1, 2002.  We purchased the residence in January 2002 and sold it in March 2002 for $541,000, recognizing a loss, including real estate fees, of $93,000.

 

13.  NEW ACCOUNTING PRONOUNCEMENTS:

 

Accounting For Certain Financial Instruments with Characteristics of Both Liabilities and Equity

In May 2003, the FASB approved SFAS No. 150, “Accounting for Certain Financial Instruments with Characteristics of Both Liabilities and Equity.”  SFAS No. 150 establishes standards for how to classify and measure financial instruments with characteristics of both liabilities and equity.  It requires financial instruments that fall within its scope to be classified as liabilities.  SFAS No. 150 is effective for financial instruments entered into or modified after May 31, 2003 and, for pre-existing financial instruments, as of July 1, 2003.  We do not have any financial instruments that fall under the guidance of SFAS No. 150 and, therefore, the adoption did not have any effect on our financial position or results of operations.

 

Accounting For Derivative Instruments and Hedging Activities

In May 2003, the FASB issued SFAS No. 149, “Amendment of Statement 133 on Derivative Instruments and Hedging Activities.”  SFAS No. 149 addresses certain accounting issues related to hedging activity and derivative instruments embedded in other contracts.  In general, the amendments require contracts with comparable characteristics to be accounted for similarly.  In addition, SFAS No. 149 provides guidance as to when a financing component of a derivative must be given special

 

46



 

reporting treatment in the statement of cash flows.  SFAS No. 149 is effective for contracts entered into or modified after June 30, 2003.  We do not utilize derivative or hedging instruments and, therefore, the adoption of SFAS No. 149 did not have any effect on our financial position, results of operations or cash flows.

 

Accounting for Costs Associated with Exit or Disposal Activities

In July 2002, the FASB approved SFAS No. 146, “Accounting for Costs Associated with Exit or Disposal Activities.”  SFAS No. 146 addresses the financial accounting and reporting for obligations associated with an exit activity, including restructuring, or with a disposal of long-lived assets.  Exit activities include, but are not limited to, eliminating or reducing product lines, terminating employees and contracts and relocating plant facilities or personnel.  SFAS No. 146 specifies that a company will record a liability for a cost associated with an exit or disposal activity only when that liability is incurred and can be measured at fair value.  Therefore, commitment to an exit plan or a plan of disposal expresses only management’s intended future actions and, therefore, does not meet the requirement for recognizing a liability and the related expense.  SFAS No. 146 is effective prospectively for exit or disposal activities initiated after December 31, 2002, with earlier adoption encouraged.  The adoption of SFAS No. 146 on January 1, 2003 did not have any effect on our financial position, results of operations or cash flows.

 

Revenue Arrangements with Multiple Deliverables

In November 2002, the EITF reached a consensus on Issue No. 00-21, “Revenue Arrangements with Multiple Deliverables.”  EITF No. 00-21 addresses certain aspects of the accounting by a vendor for arrangements under which the vendor will perform multiple revenue generating activities. EITF No. 00-21 became effective for interim periods beginning after June 15, 2003. The adoption of the provisions of EITF No. 00-21 did not have any effect on our financial position, results of operations or cash flows.

 

Revenue Recognition

In December 2003, the SEC issued Staff Accounting Bulletin No. 104, “Revenue Recognition” (SAB 104), which updates the previously issued revenue recognition guidance in SAB 101, based on the Emerging Issues Task Force Issue 00-21, “Revenue Arrangements with Multiple Deliverables.”  If the deliverables in a sales arrangement constitute separate units of accounting according to the EITF’s separation criteria, the revenue-recognition policy must be determined for each identified unit.  If the arrangement is a single unit of accounting under the separation criteria, the revenue-recognition policy must be determined for the entire arrangement.  The issuance of SAB 104 has not had any impact on our financial position, results of operations or cash flow.

 

Variable Interest Entities

In January 2003, the FASB issued FASB Interpretation No. 46 (FIN 46), “Consolidation of Variable Interest Entities, An Interpretation of ARB No. 51.”  FIN 46 provides guidance on: 1) the identification of entities for which control is achieved through means other than through voting rights, known as “variable interest entities” (VIEs); and 2) which business enterprise is the primary beneficiary and when it should consolidate the VIE.  This new model for consolidation applies to entities: 1) where the equity investors (if any) do not have a controlling financial interest; or 2) whose equity investment at risk is insufficient to finance that entity’s activities without receiving additional subordinated financial support from other parties.  In addition, FIN 46 requires that both the primary beneficiary and all other enterprises with a significant variable interest in a VIE make additional disclosures.  FIN 46 is effective for all new VIEs created or acquired after January 31, 2003.  For VIEs created or acquired prior to February 1, 2003, FIN 46 must be applied for the first interim or annual period beginning after June 15, 2003.  Certain disclosures are effective immediately. In December 2003, the FASB modified FIN 46 (FIN 46R) to clarify some requirements, and ease some implementation problems.  We must apply the new requirements by the end of the first reporting period beginning after December 15, 2003, but, at a minimum, apply the unmodified provisions of the Interpretation to entities that were considered “special-purpose entities” in practice and under the FASB literature prior to the issuance of the Interpretation by the end of the first reporting period ending after December 15, 2003. We do not have

 

47



 

any VIEs and therefore, the adoption of FIN 46 did not have any effect on our financial position or results of operations.

 

14.  UNAUDITED TRANSITIONAL PERIOD OPERATING RESULTS:

 

The following statement of operations data is included for informational purposes only and is unaudited.

 

Twelve Months Ended December 31,

 

2002

 

Revenue:

 

 

 

Net sales of products

 

$

4,093,750

 

Licensing and technology fees

 

2,718,142

 

Total revenues

 

6,811,892

 

Operating expenses:

 

 

 

Manufacturing

 

5,319,045

 

Research and development

 

3,866,058

 

Selling, general and administrative

 

5,433,206

 

Total operating expenses

 

14,618,309

 

Operating loss

 

(7,806,417

)

Interest income

 

672,626

 

Other loss

 

(95,437

)

Net loss allocable to common shareholders

 

$

(7,229,228

)

Basic and diluted net loss per common share

 

$

(0.68

)

 

15.  QUARTERLY FINANCIAL DATA (UNAUDITED):

 

Selected unaudited quarterly financial data for each of the seven quarters in the year ended December 31, 2003 and the transition period ended December 31, 2002 is as follows:

 

In thousands, except per share data

 

1st Quarter

 

2nd Quarter

 

3rd Quarter

 

4th Quarter

 

Transition Period Ended December 31, 2002

 

 

 

 

 

 

 

 

 

Revenue

 

$

1,046

 

$

1,163

 

$

2,095

 

n/a

 

Operating expenses

 

3,079

 

3,250

 

3,943

 

n/a

 

Net loss

 

(1,798

)

(1,922

)

(1,745

)

n/a

 

Basic and diluted net loss per share

 

(0.17

)

(0.18

)

(0.16

)

n/a

 

 

 

 

 

 

 

 

 

 

 

Year Ended December 31, 2003

 

 

 

 

 

 

 

 

 

Revenue

 

$

1,100

 

$

1,420

 

$

1,442

 

$

2,358

 

Operating expenses

 

3,406

 

3,876

 

3,906

 

4,716

 

Net loss

 

(2,215

)

(2,391

)

(2,393

)

(2,333

)

Basic and diluted net loss per share

 

(0.21

)

(0.22

)

(0.22

)

(0.22

)

 

16.  SUBSEQUENT EVENTS (Unaudited)

 

In February 2004,  Elan Pharmaceuticals Investments, Ltd. converted all 952,738 shares it held of our Series A preferred stock into a total of 1,905,476 shares of our common stock and all 391,830 shares it held of our Series C preferred stock into a total of 783,660 shares of our common stock.  Following these conversions, we no longer have any Series A or Series C preferred stock outstanding.  Elan still holds Series P warrants exercisable for 505,334 shares of our common stock at a price of $7.50 per share, which expire on June 30, 2006.

 

In March 2004, we signed a second license and supply agreement with Merial.  Under terms of the agreement, we will provide Merial with an exclusive license for use of a modified version of the Vitajet® needle-free injector system for use in veterinary clinics to administer vaccines for the companion animal market.  This new contract expands Merial’s use of our needle-free injection systems and includes product licensing and royalty payments on Merial’s vaccines utilizing the needle-free delivery systems in companion animals.  The product is expected to be commercialized in 2005.

 

48



 

Item 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE

 

On May 10, 2002,  the Audit Committee of our Board of Directors approved the dismissal of our independent public accountants, Arthur Andersen LLP.  Arthur Andersen LLP’s report on our financial statements for the fiscal year ended March 31, 2001 did not contain an adverse opinion or disclaimer of opinion and were not qualified or modified as to uncertainty, audit scope or accounting principles.  During the fiscal year ended March 31, 2001 and during the subsequent interim period through the date of dismissal, May 10, 2002, there were not any disagreements between us and Arthur Andersen LLP on any matters of accounting principles or practices, financial statement disclosure or auditing scope or procedure, or any reportable events as defined under Item 304(a)(1)(v) of Regulation S-K promulgated by the Securities and Exchange Commission.

 

Also on May 10, 2002, based on the recommendation of the Audit Committee of our Board of Directors, we engaged the firm of KPMG LLP to be our independent public accountants. We did not consult KPMG LLP at any time prior to May 10, 2002 with respect to the application of accounting principles to a specified transaction, either completed or proposed, or the type of audit opinion that might be rendered on our financial statements, or concerning any disagreement or reportable event with Arthur Andersen LLP.

 

Item 9A. CONTROLS AND PROCEDURES

 

Disclosure Controls and Procedures

Our management has evaluated, under the supervision and with the participation of our President and Chief Executive Officer and Chief Financial Officer, the effectiveness of our disclosure controls and procedures as of the end of the period covered by this report pursuant to Rule 13a-15(b) under the Securities Exchange Act of 1934 (the “Exchange Act”). Based on that evaluation, our President and Chief Executive Officer and Chief Financial Officer have concluded that, as of the end of the period covered by this report, our disclosure controls and procedures are effective in ensuring that information required to be disclosed in our Exchange Act reports is (1) recorded, processed, summarized and reported in a timely manner, and (2) accumulated and communicated to our management, including our President and Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosure.

 

Internal Control Over Financial Reporting

There has been no change in our internal control over financial reporting that occurred during our last fiscal quarter that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

 

PART III

 

We have omitted from Part III the information that will appear in our definitive proxy statement for our 2004 Annual Meeting of Shareholders (the “Proxy Statement”), which will be filed within 120 days after the end of our year ended December 31, 2003 pursuant to Regulation 14A.

 

Item 10.  DIRECTORS AND EXECUTIVE OFFICERS OF THE REGISTRANT

 

The information required by this item is included in our Proxy Statement for our 2004 Annual Meeting of Shareholders and is incorporated herein by reference.

 

Item 11.  EXECUTIVE COMPENSATION

 

The information required by this item is included in our Proxy Statement for our 2004 Annual Meeting of Shareholders and is incorporated herein by reference.

 

49



 

Item 12.  SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT

 

EQUITY COMPENSATION PLAN INFORMATION

 

The following table summarizes equity securities authorized for issuance as of December 31, 2003.

 

Plan Category

 

Number of securities
to be issued upon
exercise of
outstanding options,
warrants and rights (a)

 

Weighted average
exercise price of
outstanding options,
warrants and rights (b)

 

Number of securities
remaining available for future
issuance under equity
compensation plans
(excluding securities
reflected in column (a)) (c)

 

Equity compensation plans approved by shareholders

 

2,717,396

 

$

5.96

 

1,106,531

(1)

 

 

 

 

 

 

 

 

Equity compensation plans not approved by shareholders (2)

 

68,000

 

5.82

 

 

Total

 

2,785,396

 

$

5.96

 

1,106,531

 

 


(1)    Represents 846,178 shares of common stock available for issuance under our 1992 Stock Incentive Plan and 260,353 shares of common stock available for purchase under our 2000 Employee Stock Purchase Plan.  Under the terms of 1992 Stock Incentive Plan, a committee of the Board of Directors may authorize the sales of common stock, grant incentive stock options or nonstatutory stock options, and award stock bonuses and stock appreciation rights to eligible employees, officers and directors and eligible non-employee agents, consultants, advisers and independent contractors of Bioject or any parent or subsidiary.

(2)    We have issued warrants to purchase an aggregate of 68,000 shares of common stock to various non-employee consultants. The warrants are fully exercisable and have grant dates ranging from February 1998 to May 2002, terms ranging from three years to six years and exercise prices ranging from $2.80 to $10.34.

 

Additional information required by this item is included in our Proxy Statement for our 2004 Annual Meeting of Shareholders and is incorporated herein by reference.

 

Item 13.  CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS

 

The information required by this item is included in our Proxy Statement for our 2004 Annual Meeting of Shareholders and is incorporated herein by reference.

 

Item 14.  PRINCIPAL ACCOUNTANT FEES AND SERVICES

 

The information required by this item is included in our Proxy Statement for our 2004 Annual Meeting of Shareholders and is incorporated herein by reference.

 

50



 

PART IV
 
Item 15.  EXHIBITS, FINANCIAL STATEMENT SCHEDULES AND REPORTS ON FORM 8-K

 

Financial Statements and Schedules

The Consolidated Financial Statements, together with the report thereon of KPMG LLP, are included on the pages indicated below:

 

 

 

 

 

Report of KPMG LLP

 

 

 

 

 

Consolidated Balance Sheets as of December 31, 2003 and 2002

 

 

 

 

 

Consolidated Statements of Operations for the year ended December 31, 2003, the nine month transition period ended December 31, 2002 and the year ended March 31, 2002

 

 

 

 

 

Consolidated Statements of Shareholders’ Equity for the year ended December 31, 2003, the nine month transition period ended December 31, 2002 and the year ended March 31, 2002

 

 

 

 

 

Consolidated Statements of Cash Flows for the year ended December 31, 2003, the nine month transition period ended December 31, 2002 and the year ended March 31, 2002

 

 

 

 

 

Notes to Consolidated Financial Statements

 

 

There are no schedules required to be filed herewith.

 

Reports on Form 8-K

We filed one current report one Form 8-K pursuant to Items 7 and 12 during the quarter ended December 31, 2003.

 

Exhibits

The following exhibits are filed herewith and this list is intended to constitute the exhibit index.

 

Exhibit No.

 

Description

3.1

 

2002 Restated Articles of Incorporation of Bioject Medical Technologies Inc.  Incorporated by reference to our Form 10-Q for the quarter ended June 30, 2003 as filed with the Securities and Exchange Commission on August 7, 2003.

3.2

 

Second Amended and Restated Bylaws of Bioject Medical Technologies, Inc.  Incorporated by reference to Exhibit 3 to the Company’s Form 10-Q for the quarter ended December 31, 2000.

10.1

 

Employment Agreement with James C. O’Shea dated October 3, 1995.Incorporated  by reference to the Company’s Form 10-Q for the quarter ended September 30, 1995.

10.2

 

Amended Employment Agreement between Bioject Inc. and Joseph Michael Redmond dated February 8, 2000.  Incorporated by reference to Exhibit 10.5 to the Company’s Form 10-K for the year ended March 31, 2000.

10.3

 

Executive Employment Agreement between Bioject Inc. and Christopher Pugh dated April 3, 2002. Incorporated by reference to Exhibit 10.3 to the Company’s Form 10-K for the nine-month transition period ended December 31, 2002.

10.4

 

Executive Employment Agreement between Bioject Inc. and Eric Mishkin, Ph.D. dated April 8, 2002. Incorporated by reference to Exhibit 10.4 to the Company’s Form 10-K for the nine-month transition period ended December 31, 2002.

10.5

 

Amended and Restated Executive Employment Agreement dated March 14, 2002 between Bioject Medical Technologies Inc. and John Gandolfo. Incorporated by reference to the Company’s Form 10-K for the year ended March 31, 2002.

10.6

 

Amended and Restated Executive Employment Agreement dated March 14, 2002 between Bioject Medical Technologies Inc. and Michael A. Temple. Incorporated by reference to the Company’s Form 10-K for the year ended March 31, 2002.

10.7

 

Restated 1992 Stock Incentive Plan.  Incorporated by reference to Exhibit 10 to the Company’s Form 10-Q for the quarter ended September 30, 2000.

10.8

 

Lease Agreement dated September 10, 1996 between Bridgeport Woods Business Park and Bioject Inc. for the Portland, Oregon facility.Incorporated by reference to Company’s Form 10-Q for the quarter ended September 30, 1996.

 

51



 

Exhibit No.

 

Description

10.8.1

 

First Amendment dated November 20, 1997 to Lease Agreement dated September 10, 1996 by and between Bridgeport Woods Business Park, LLC and Bioject, Inc.  Incorporated by reference to Exhibit 10.6.1 to the Company’s Form 10-K for the nine-month transition period ended December 31, 2002.

10.8.2

 

Second Amendment dated April 22, 2002 to Lease Agreement dated September 10, 1996 by and between Bridgeport Woods Business Park, LLC and Bioject, Inc.  Incorporated by reference to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2002.

10.9

 

Lease Extension Agreement dated June 5, 2002, by and between Earl J. Itel and Lois Itel Trust and Bioject, Inc. for the 6000 sq. ft. Tualatin, Oregon warehouse. Incorporated by reference to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2002.

10.10

 

Industrial Lease dated October 2003 between Multi-Employer Property Trust, and Bioject Medical Technologies, Inc., an Oregon corporation. Incorporated by reference to Exhibit 10.8 to the Company’s Form 10-K for the nine-month transition period ended December 31, 2002.

10.11

 

Form of Series “J” Common Stock Purchase Warrant.  Incorporated by reference to the Company’s Form 10-K for the year ended March 31, 1998.

10.12

 

Form of Series “N” Common Stock Purchase Warrant.Incorporated by reference to the Company’s Form 10-K for the year ended March 31, 1998.

10.13

 

Form of Series “O” Common Stock Purchase Warrant.  Incorporated by reference to the Company’s Form 10-K for the year ended March 31, 1999.

10.14

 

Form of Series “P” Common Stock Purchase Warrant, as amended.  Incorporated by reference to Exhibit 10.2 to the Company’s Form 10-Q for the quarter ended December 31, 2001.

10.15

 

Form of Series “R” Common Stock Purchase Warrant.  Incorporated by reference to the Company’s Form 10-K for the year ended March 31, 2000.

10.16

 

Securities Purchase Agreement between Elan International Services, Ltd. and Bioject Medical Technologies Inc. dated October 15, 1997. Incorporated by reference to Exhibit 10.41 to the Company’s Form 8-K filed October 31, 1997.

10.17

 

Agreement dated December 12, 2001 between the Company, Elan Pharmaceutical Investments, Ltd. and Elan International Services, Ltd.  Incorporated by reference to Exhibit 10.1 to the Company’s Form 10-Q for the quarter ended December 31, 2001.

10.18

 

License and Distribution Agreement dated December 21, 1999 between Bioject, Inc. and Serono Laboratories, Inc. 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.  Incorporated by reference to the Company’s Form 10-Q for the quarter ended December 31, 1999.

10.18.1

 

Amendment dated March 15, 2000 to License and Distribution Agreement dated December 21, 1999 between Bioject, Inc. and Serono Laboratories, Inc.  Incorporated by reference to the Company’s Form 10-K for the year ended March 31, 2000.

10.19

 

License and Development Agreement dated February 29, 2000 between Bioject Inc. and Amgen Inc. 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.  Incorporated by reference to the Company’s Form 10-K for the year ended March 31, 2000.

10.20

 

Form of Series “S” Common Stock Purchase Warrant.  Incorporated by reference to the Company’s Form 10-K for the year ended March 31, 2001.

10.20.1

 

Form of Registration Rights Agreement for Series “S” Common Stock.  Incorporated by reference to the Company’s Form 10-K for the year ended March 31, 2001.

10.21

 

Form of Series “T” Common Stock Purchase Warrant. Incorporated by reference to the Company’s Form 10-K for the year ended March 31, 2001.

10.21.1

 

Form of Registration Rights Agreement for Series “T” Common Stock.  Incorporated by reference to the Company’s Form 10-K for the year ended March 31, 2001.

10.22

 

Form of Series “U” Common Stock Purchase Warrant.  Incorporated by reference to the Company’s Form 10-K for the year ended March 31, 2001.

10.22.1

 

Form of Registration Rights Agreement for Series “U” Common Stock.  Incorporated by reference to the Company’s Form 10-K for the year ended March 31, 2001.

10.23

 

Form of Series “V” Common Stock Purchase Warrant.  Incorporated by reference to the Company’s Form 10-K for the year ended March 31, 2001.

 

52



 

Exhibit No.

 

Description

10.23.1

 

Form of Registration Rights Agreement for Series “V” Common Stock.  Incorporated by reference to the Company’s Form 10-K for the year ended March 31, 2001.

10.24

 

Form of Series “W” Common Stock Purchase Warrant. Incorporated by reference to the Company’s Form 10-K for the year ended March 31, 2001.

10.24.1

 

Form of Registration Rights Agreement for Series “W” Common Stock.  Incorporated by reference to the Company’s Form 10-K for the year ended March 31, 2001.

10.25

 

Form of Series “X” Common Stock Purchase Warrant.  Incorporated by reference to the Company’s Form S-3 dated January 30, 2002.

10.26

 

Form of Series “Y” Common Stock Purchase Warrant.  Incorporated by reference to the Company’s Form S-3 dated January 30, 2002.

10.27

 

Form of Series “Z” Common Stock Purchase Warrant.  Incorporated by reference to the Company’s Form S-3 dated January 30, 2002.

10.28

 

Form of Registration Rights Agreement between Bioject Medical Technologies Inc. and Leerink Swann & Company dated December 2001. Incorporated by reference to the Company’s Form S-3 dated January 30, 2002.

10.29

 

Form of Series “AA-1” Common Stock Purchase Warrant. Incorporated by reference to Exhibit 10.28 to the Company’s Form 10-K for the nine-month transition period ended December 31, 2002.

10.30

 

Form of Rights Agreement dated as of July 1, 2002 between the Company and American Stock Transfer & Trust Company, including Exhibit A, Terms of the Preferred Stock, Exhibit B, Form of Rights Certificate, and Exhibit C, Summary of the Right To Purchase Preferred Stock.  Incorporated by reference to Exhibit 4 to the Registrant’s Current Report on Form 8-K dated July 2, 2002.

10.30.1

 

First Amendment dated October 8, 2002 to Rights Agreement dated July 1, 2002 between Bioject and American Stock Transfer & Trust Company.  Incorporated by reference to our registration statement on Form 8-A/A filed with the Commission on October 8, 2002.

10.31

 

$1.5 million Single Note Payable dated November 25, 2003 between U.S. Bank and Bioject Medical Technologies Inc.

10.31.1

 

Term loan commitment dated February 13, 2004 between U.S. Bank and Bioject Medical Technologies Inc.

14

 

Code of Ethics

16

 

Letter re change in certifying accountant.  Incorporated by reference to the Company’s Form 8-K/A-3 dated May 10, 2002.

21

 

List of Subsidiaries. Incorporated by reference to the Company’s Form 10-K for the year ended March 31, 1999.

23

 

Consent of KPMG LLP

31.1

 

Certification of James C. O’Shea pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

31.2

 

Certification of John Gandolfo pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

32.1

 

Certification of James C. O’Shea Pursuant to 18 U.S.C. Section 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

32.2

 

Certification of John Gandolfo Pursuant to 18 U.S.C. Section 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

 

53



 

SIGNATURES

 

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, Bioject Medical Technologies Inc. has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized on March 24, 2004:

 

 

BIOJECT MEDICAL TECHNOLOGIES INC.

 

(Registrant)

 

 

 

By:

/S/ JAMES C. O’SHEA

 

 

James C. O’Shea

 

Chairman of the Board, President
and Chief Executive Officer

 

(Principal Executive Officer)

 

Pursuant to the request of the Securities Exchange Act of 1934, this report has been signed below on behalf of the Registrant and in the capacities indicated on March 24, 2004.

 

SIGNATURE

 

TITLE

 

 

 

/S/ JAMES C. O’SHEA

 

 

Chairman of the Board, President

James C. O’Shea

 

and Chief Executive Officer

 

 

(Principal Executive Officer)

 

 

 

/S/ JOHN GANDOLFO

 

 

Chief Financial Officer

John Gandolfo

 

(Principal Financial and Accounting Officer)

 

 

 

/s/ SANDRA PANEM

 

 

Director

Sandra Panem

 

 

 

 

 

 

 

 

/s/ EDWARD L. FLYNN

 

 

Director

Edward L. Flynn

 

 

 

 

 

 

 

 

/S/ WILLIAM A. GOUVEIA

 

 

Director

William A. Gouveia

 

 

 

 

 

 

 

 

/S/ ERIC T. HERFINDAL

 

 

Director

Eric T. Herfindal

 

 

 

 

 

 

 

 

/S/ JOSEPH IANELLI

 

 

Director

Joseph Ianelli

 

 

 

 

 

 

 

 

/S/ RICHARD PLESTINA

 

 

Director

Richard Plestina

 

 

 

 

 

 

 

 

/S/ JOHN RUEDY, M.D.

 

 

Director

John Ruedy, M.D.

 

 

 

54


EX-10.31 3 a04-1725_1ex10d31.htm EX-10.31

Exhibit 10.31

 

 

For Bank Use Only

 

Reviewed by

 

 

 

 

 

Due  May 31, 2004

 

 

 

Customer #  0013592421

 

Loan #  34

 

INSTALLMENT OR SINGLE PAYMENT NOTE

 

$1,500,00.00

 

 

NOVEMBER 25, 2003

 

FOR VALUE RECEIVED, the undersigned borrower (the “Borrower”), promises to pay to the order of U.S. BANK N.A. (the “Bank”), the principal sum of ONE MILLION FIVE HUNDRED THOUSAND AND NO/100 Dollars ($ 1,500,00.00) the “Loan Amount”).

 

1.               Terms for Advance(s).  [Choose One:]s

 

o           Single Advance.

 

ý            Multiple Advances. Prior to MAY 31, 2004 or the earlier termination hereof, the Borrower may obtain advances from the Bank under this Note in an aggregate amount not exceeding the Loan Amount.  Although this Note is expressed as payable in the full Loan Amount, the Borrower will be obligated to pay only the amounts actually disbursed hereunder, together with accrued interest on the outstanding balance at the rates and on the dates specified therein and such other charges provided for herein.

 

2.               Interest.

The unpaid principal balance will bear interest at an annual rate equal to the prime rate announced by the Bank.

 

The interest rate hereunder will be adjusted each time that the prime rate changes.

 

 

3.               Payment Schedule.

Interest is payable beginning DECEMBER 31, 2003, and on the same date of each CONSECUTIVE month thereafter (except that if a given month does not have such a date, the last day of such month), plus a final interest payment with the final payment of principal.

 

Principal is payable on MAY 31, 2004.

 

 

4.               Closing Fee.  o  If checked here, the Borrower will pay the Bank a one-time closing fee of $ n/a contemporaneously with execution of this Note. This fee is in addition to all other fees, expenses and other amounts due hereunder.

 

5.               Late Payment Fee.  Subject to applicable law, if any payment is not made on or before its due date, the Bank may collect a delinquency charge of 5.00% of the unpaid amount. Collection of the late payment fee shall not be deemed to be a waiver of the Bank’s right to declare a default hereunder.

 

6.               Calculation of Interest.  Interest will be computed for the actual number of days principal is unpaid, using a daily factor obtained by dividing the stated interest rate by 360.

 

7.               Default Interest Rate.  Notwithstanding any provision of this Note to the contrary, upon any default or at any time during the continuation thereof (including failure to pay upon maturity), the Bank may, at its option and subject to applicable law, increase the interest rate on this Note to a rate of 5% per annum plus the interest rate otherwise payable hereunder. Notwithstanding the foregoing and subject to applicable law, upon the occurrence of a default by the Borrower or any guarantor involving bankruptcy, insolvency, receivership proceedings or an assignment for the benefit of creditors, the interest rate on this Note shall automatically increase to a rate of 5% per annum plus the rate otherwise payable hereunder.

 

8.               Maximum Rate.  In no event will the interest rate hereunder exceed that permitted by applicable law.  If any interest or other charge is finally determined by a court of competent jurisdiction to exceed the maximum amount permitted by law, the interest or charge shall be reduced to the maximum permitted by law, and the Bank may credit any excess amount previously collected against the balance due or refund the amount to the Borrower.

 

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9.               Additional Terms.

 

 

10.         Financial Information.  The Borrower will (i) maintain accounting records in accordance with generally recognized and accepted principles of accounting consistently applied throughout the accounting periods involved; (ii) provide the Bank with such information concerning its business affairs and financial condition (including insurance coverage) as the Bank may reasonably request; and (iii) without request, provide the Bank with annual financial statements prepared by an accounting firm acceptable to the Bank within 120 days of the end of each fiscal year.

 

11.         Credit Balances; Setoff.   As additional security for the payment of the obligations described in this Note or any document securing or related to the loan evidenced by this Note (collectively the “Loan Documents”) and any other obligations of the Borrower to the Bank of any nature whatsoever (collectively the “Obligations”), the Borrower hereby grants to the Bank a security interest in, a lien on and an express contractual right to set off against all depository account balances, cash and any other property of the Borrower now or hereafter in the possession of the Bank and the right to refuse to allow withdrawals from any account (collectively “Setoff”).  The Bank may, at any time upon the occurrence of a default hereunder (notwithstanding any notice requirements or grace/cure periods under this or other agreements between the Borrower and the Bank) Setoff against the Obligations whether or not the Obligations (including future installments) are then due or have been accelerated, all without any advance or contemporaneous notice or demand of any kind to the Borrower, such notice and demand being expressly waived.

 

12.         Advances and Paying Procedure.  The Bank is authorized and directed to credit any of the Borrower’s accounts with the Bank (or to the account the Borrower designates in writing) for all loans made hereunder, and the Bank is authorized to debit such account or any other account of the Borrower with the Bank for the amount of any principal, interest or expenses due under the Note or other amount due hereunder on the due date with respect thereto.  Payments due under the Note and other Loan Documents will be made in lawful money of the United States.  All payments may be applied by the Bank to principal, interest and other amounts due under the Loan Documents in any order which the Bank elects.  If, upon any request by the Borrower to the Bank to issue a wire transfer, there is an inconsistency between the name of the recipient of the wire and its identification number as specified by the Borrower, the Bank may, without liability, transmit the payment via wire based solely upon the identification number.

 

13.         Defaults.  Notwithstanding any cure periods described below, the Borrower shall immediately notify the Bank in writing when the Borrower obtains knowledge of the occurrence of any default specified below.  Regardless of whether the Borrower has given the required notice, the occurrence of one or more of the following shall constitute a default:

(a)          Nonpayment.  The Borrower shall fail to pay (i) any interest due on this Note or any fees, charges, costs or expenses under the Loan Documents by 5 days after the same becomes due; or (ii) any principal amount of this Note when due.

(b)         Nonperformance.  The Borrower or any guarantor of the Borrower’s Obligations to the Bank (“Guarantor”) shall fail to perform or observe any agreement, term, provision, condition, or covenant (other than a default occurring under (a), (c), (d), (e), (f) or (g) of this paragraph 13) required to be performed or observed by the Borrower or any Guarantor hereunder or under any other Loan Document or other agreement with or in favor of the Bank.

(c)          Misrepresentation.  Any financial information, statement, certificate, representation or warranty given to the Bank by the Borrower or any Guarantor (or any of their representatives) in connection with entering into this Note or the other Loan Documents and/or any borrowing thereunder, or required to be furnished under the terms thereof, shall prove untrue or misleading in any material respect (as determined by the Bank in the exercise of its judgment) as of the time when given.

(d)         Default on Other Obligations.  The Borrower or any Guarantor shall be in default under the terms of any loan agreement, promissory note, lease, conditional sale contract or other agreement, document or instrument evidencing, governing or securing any indebtedness owing by the Borrower or any Guarantor to the Bank or any indebtedness in excess of $10,000 owing by the Borrower to any third party, and the period of grace, if any, to cure said default shall have passed.

(e)          Judgments.  Any judgment shall be obtained against the Borrower or any Guarantor which, together with all other outstanding unsatisfied judgments against the Borrower (or such Guarantor), shall exceed the sum of $10,000 and shall remain unvacated, unbonded or unstayed for a period of 30 days following the date of entry thereof.

(f)            Inability to Perform; Bankruptcy/Insolvency.  (i) The Borrower or any Guarantor shall die or cease to exist; or (ii) any Guarantor shall attempt to revoke any guaranty of the Obligations described herein, or any guaranty becomes unenforceable in whole or in part for any reason; or (iii) any bankruptcy, insolvency or receivership proceedings, or an assignment for the benefit of creditors, shall be commenced under any Federal or state law by or against the Borrower or any Guarantor; or (iv) the Borrower or any Guarantor shall become the subject of any out-of-court settlement with its creditors; or (v) the Borrower or any Guarantor is unable or admits in writing its inability to pay its debts as they mature; or (vi) if the Borrower is a limited liability company, any member thereof shall withdraw or otherwise become disassociated from the Borrower.

(g)         Adverse Change; Insecurity.  (i) There is a material adverse change in the business, properties, financial condition or affairs of the Borrower or any Guarantor, or in any collateral securing the Obligations; or (ii) the Bank in good faith deems itself insecure.

 

14.         Termination of Loans; Additional Bank Rights.  Upon the occurrence of any of the events identified in paragraph 13, the Bank may at any time (notwithstanding any notice requirements or grace/cure periods under this or other agreements between the Borrower

 

2



 

and the Bank) (i) immediately terminate its obligation, if any, to make additional loans to the Borrower; (ii) Setoff; and/or (iii) take such other steps to protect or preserve the Bank’s interest in any collateral, including without limitation, notifying account debtors to make payments directly to the Bank, advancing funds to protect any collateral and insuring collateral at the Borrower’s expense; all without demand or notice of any kind, all of which are hereby waived.

 

15.         Acceleration of Obligations.  Upon the occurrence of any of the events identified in paragraph 13(a) through 13(e) and 13(g), and the passage of any applicable cure periods, the Bank may at any time thereafter, by written notice to the Borrower, declare the unpaid principal balance of any Obligations, together with the interest accrued thereon and other amounts accrued hereunder and under the other Loan Documents, to be immediately due and payable; and the unpaid balance shall thereupon be due and payable, all without presentation, demand, protest or further notice of any kind, all of which are hereby waived, and notwithstanding anything to the contrary contained herein or in any of the other Loan Documents.  Upon the occurrence of any event under paragraph 13(f), the unpaid principal balance of any Obligations, together with all interest accrued thereon and other amounts accrued hereunder and under the other Loan Documents, shall thereupon be immediately due and payable, all without presentation, demand, protest or notice of any kind, all of which are hereby waived, and notwithstanding anything to the contrary contained herein or in any of the other Loan Documents. Nothing contained in paragraph 13 or 14 or this paragraph shall limit the Bank’s right to Setoff as provided in this Note.

 

16.         Collateral.  This Note is secured by any and all security interests, pledges, mortgages or liens now or hereafter in existence granted to the Bank to secure indebtedness of the Borrower to the Bank (unless prohibited by law), including, without limitation, as described in the following documents: COLLATERAL PLEDGE AGREEMENT DATED NOVEMBER 25, 2003

 

17.         Guaranties.  This Note is guarantied by each and every guaranty now or hereafter in existence guarantying the indebtedness of the Borrower to the Bank (except for any guaranty expressly limited by its terms to a specific separate obligation of Borrower to the Bank) including, without limitation, the following: N/A

 

 

18.         Additional Bank Rights.  Without affecting the liability of any Borrower, endorser, surety or guarantor, the Bank may, without notice, renew or extend the time for payment, accept partial payments, release or impair any collateral security for the payment of this Note, or agree not to sue any party liable on it.

 

19.         Warranties.  The Borrower makes the following warranties: (A) This Note and the other Loan Documents are the legal, valid and binding obligations of the Borrower, enforceable against the Borrower in accordance with their terms. (B) The execution, delivery and performance of this Note and all other Loan Documents to which the Borrower is a party (i) are within the borrower’s power; (ii) have been duly authorized by all appropriate entity action; (iii) do not require the approval of any governmental agency; and (iv) will not violate any law, agreement or restriction by which the Borrower is bound. (C) If the Borrower is not an individual, the Borrower is validly existing and in good standing under the laws of its state of organization, has all requisite power and authority and possesses all licenses necessary to conduct its business and own its properties.

 

20.         Waivers; Relationship to Other Documents.  All Borrowers, endorsers, sureties and guarantors waive presentment, protest, demand, and notice of dishonor. No delay on the part of the Bank in exercising any right, power or privilege hereunder or under any of the other Loan Documents will operate as a waiver thereof, nor will any single or partial exercise of any right, power or privilege hereunder preclude other or further exercise thereof or the exercise of any other right, power or privilege. The warranties, covenants and other obligations of the Borrower (and rights and remedies of the Bank) in this Note and all related documents are intended to be cumulative and to supplement each other.

 

21.         Expenses and Attorneys’ Fees.  Upon demand, the Borrower will immediately reimburse the Bank and any participant in the Obligations (“Participant”) for all attorneys’ fees and all other costs, fees and out-of-pocket disbursements incurred by the Bank or any Participant in connection with the preparation, execution, delivery, administration, defense and enforcement of this Note or any of the other Loan Documents, including attorneys’ fees and all other costs and fees (a) incurred before or after commencement of litigation or at trial, on appeal or in any other proceeding, (b) incurred in any bankruptcy proceeding and (c) related to any waivers or amendments with respect thereto (examples of costs and fees include but are not limited to fees and costs for: filing, perfecting or confirming the priority of the Bank’s lien, title searches or insurance, appraisals, environmental audits and other reviews related to the Borrower, any collateral or the loans, if requested by the Bank).  The Borrower will also reimburse the Bank and any Participant for all costs of collection before and after judgment, and the costs of preservation and/or liquidation of any collateral.

 

22.         Applicable Law and Jurisdiction; Interpretation; Joint Liability; Severability. This Note and all other Loan Documents shall be governed by and interpreted in accordance with the internal laws of the State of OREGON, except to the extent superseded by Federal law.  Invalidity of any provisions of this Note shall not affect any other provision.  THE BORROWER HEREBY CONSENTS TO THE EXCLUSIVE JURISDICTION OF ANY STATE OR FEDERAL COURT SITUATED IN THE COUNTY OR FEDERAL JURISDICTION OF THE BANK’S BRANCH WHERE THE LOAN WAS ORIGINATED, AND WAIVES ANY OBJECTION BASED ON FORUM NON CONVENIENS, WITH REGARD TO ANY ACTIONS, CLAIMS, DISPUTES OR PROCEEDINGS RELATING TO THIS NOTE, THE COLLATERAL, ANY OTHER LOAN DOCUMENT, OR ANY TRANSACTIONS ARISING THEREFROM, OR ENFORCEMENT AND/OR INTERPRETATION OF ANY OF THE FOREGOING. Nothing herein shall affect the Bank’s rights to serve process in any manner permitted by law, or limit the Bank’s right to bring proceedings against the Borrower in the competent courts of any other jurisdiction or jurisdictions.  This Note, the other Loan Documents and any amendments hereto (regardless of when executed) will be deemed effective and accepted only upon the Bank’s receipt of the executed originals thereof. If there is more than one Borrower, the liability of the Borrowers shall be joint and several, and the reference to “Borrower” shall be deemed to refer to all Borrowers.  Invalidity of any provision of this Note shall not affect the validity of any other provision.

 

3



 

23.         Participations/Guarantors/Successors.  The Bank may, at its option, sell all or any interests in the Note and other Loan Documents to other financial institutions (the “Participant”), and in connection with such sales (and thereafter) disclose any financial information the Bank may have concerning the Borrower to any such Participant or potential Participant.  From time to time, the Bank may, in its discretion and without obligation to the Borrower, any Guarantor or any other third party, disclose information about the Borrower and this loan to any Guarantor, surety or other accommodation party.  This provision does not obligate the Bank to supply any information or release the Borrower from its obligation to provide such information, and the Borrower agrees to keep all Guarantors advised of its financial condition and other matters which may be relevant to the Guarantors’ obligations to the Bank.  The rights, options, powers and remedies granted in this Agreement and the other Loan Documents will extend to the Bank and to its successors and assigns, will be binding upon the Borrower and its successors and assigns and will be applicable hereto and to all renewals and/or extensions hereof.

 

24.         Copies; Entire Agreement; Modification.  The Borrower hereby acknowledges the receipt of a copy of this Note and all other Loan Documents.  This Note is a “transferable record” as defined in applicable law relating to electronic transactions.  Therefore, the holder of this Note may, on behalf of Borrower, create a microfilm or optical disk or other electronic image of this Note that is an authoritative copy as defined in such law.  The holder of this Note may store the authoritative copy of such Note in its electronic form and then destroy the paper original as part of the holder’s normal business practices.  The holder, on its own behalf, may control and transfer such authoritative copy as permitted by such law.

 

IMPORTANT: READ BEFORE SIGNING.  THE TERMS OF THIS AGREEMENT SHOULD BE READ CAREFULLY BECAUSE ONLY THOSE TERMS IN WRITING, EXPRESSING CONSIDERATION AND SIGNED BY THE PARTIES ARE ENFORCEABLE. NO OTHER TERMS OR ORAL PROMISES NOT CONTAINED IN THIS WRITTEN CONTRACT MAY BE LEGALLY ENFORCED. THE TERMS OF THIS AGREEMENT MAY ONLY BE CHANGED BY ANOTHER WRITTEN AGREEMENT. THIS NOTICE SHALL ALSO BE EFFECTIVE WITH RESPECT TO ALL OTHER CREDIT AGREEMENTS NOW IN EFFECT BETWEEN BORROWER AND THE BANK.  A MODIFICATION OF ANY OTHER CREDIT AGREEMENTS NOW IN EFFECT BETWEEN BORROWER AND THE BANK, WHICH OCCURS AFTER RECEIPT BY BORROWER OF THIS NOTICE, MAY BE MADE ONLY BY ANOTHER WRITTEN INSTRUMENT.  ORAL OR IMPLIED MODIFICATIONS TO SUCH CREDIT AGREEMENTS ARE NOT ENFORCEABLE AND SHOULD NOT BE RELIED UPON.

 

25.         Waiver of Jury Trial.  THE BORROWER AND THE BANK HEREBY JOINTLY AND SEVERALLY WAIVE ANY AND ALL RIGHT TO TRIAL BY JURY IN ANY ACTION OR PROCEEDING RELATING TO ANY OF THE LOAN DOCUMENTS, THE OBLIGATIONS THEREUNDER, ANY COLLATERAL SECURING THE OBLIGATIONS, OR ANY TRANSACTION ARISING THEREFROM OR CONNECTED THERETO.  THE BORROWER AND THE BANK EACH REPRESENTS TO THE OTHER THAT THIS WAIVER IS KNOWINGLY, WILLINGLY AND VOLUNTARILY GIVEN.

 

26.         Attachments. All documents attached hereto, including any appendices, schedules, riders, and exhibits to this Installment or Single Payment Note, are hereby expressly incorporated by reference.

 

 

(Individual Borrower)

 

BIOJECT MEDICAL TECHNOLOGIES INC.

 

 

Borrower Name (Organization)

 

 

 

 

 

a

OREGON Corporation

 

 

 

Borrower Name

N/A

 

By

 /s/ Michael A. Temple

 

 

 

 

 

Name and Title

MICHAEL A. TEMPLE, EXECUTIVE VICE PRESIDENT

 

 

 

 

 

By

 

 

 

 

Borrower Name

N/A

 

Name and Title

 

 

 

Borrower Address:

7620 SW BRIDGEPORT ROAD, PORTLAND, OR 97224

 

Borrower Telephone No.:

 

 

 

4



 

CORPORATE RESOLUTION FOR BORROWING AND/OR PLEDGING ASSETS

 

BIOJECT MEDICAL TECHNOLOGIES INC.

 

NAME OF CORPORATION

 

WHEREAS, this corporation may enter into financial transactions or accommodations with U.S. BANK N.A. (the “Bank”) from time to time;

 

NOW, THEREFORE, RESOLVED, that any 1 of the officers of this corporation denoted below: [mark authorized officers]

 

o

Chairman of the Board

o

Treasurer

ý

Other:

EXECUTIVE VICE PRESIDENT

o

President

o

Secretary

o

Other:

 

o

Any Vice President

o

Any Assistant Treasurer

o

Other:

 

 

 

o

Any Assistant Secretary

o

Other:

 

 

is (are) authorized, on behalf of and in the name of this corporation, (a) to borrow money from the time to time in such amounts as such officer(s) shall deem advisable; (b) to make, execute, seal with the corporate seal, and deliver to the Bank, from time to time, loan agreements, disbursing agreements, notes, applications for letters of credit, and other evidence of or agreements concerning such indebtedness, in such amounts with such maturities, at such rates of interest, and upon such terms and conditions as said officer(s) shall approve; (c) to pledge, assign, mortgage or otherwise grant a security interest in any or all real property, fixtures, tangible or intangible personal property, or any other assets of this corporation, to execute, seal with the corporate seal, and deliver to the Bank such security agreements, chattel mortgages, assignments, financing statements, real estate mortgages, deeds of trust, lease or rental assignments, assignments of life insurance, agreements not to encumber, or other agreements respecting any or all interests in real or personal property now owned or hereafter acquired by this corporation as may be requested by the Bank to secure any obligations of this corporation to the Bank or to secure the obligations of a third party to the Bank, now existing or hereafter arising, all upon such terms and conditions as said officer(s) shall approve, and to perform such acts required of this corporation in such agreements or otherwise to perfect such security interests; (d) to sell to the Bank, with or without recourse, accounts, contract rights, general intangibles, instruments, documents, chattel paper, equipment, inventory, insurance policies, deposit accounts, rights in action or other personal property of this corporation; (e) to endorse or assign and deliver such property to the Bank, and from time to time to withdraw and make substitutions of such property, or to sell such property to third persons and cause the proceeds of such sales to be applied against the obligations of this corporation to the Bank; (f) to give subordinations, guaranties or other financial accommodations to the Bank (it being the judgment of the governing body of this corporation that any such guaranties may reasonably be expected to benefit the corporation); and (g) to endorse and deliver for discount with the Bank, notes, certificates of deposit, bills of exchange, orders for the payment of money, chattel paper, commercial, or other business paper, howsoever drawn, either belonging to or coming into the possession of this corporation.  The signature(s) of said officer(s) appearing on any of the foregoing instruments shall be conclusive evidence of (his/her) (their) approval thereof.

 

FURTHER RESOLVED, that the authority granted to the officers of this corporation shall continue in full force and effect, and said Bank may rely thereon in dealing with such officers, unless and until written notice of any change in or revocation of such authority shall be delivered to said Bank to the attention of Commercial Loan Servicing by an officer or director of this corporation, and any action taken by said officers and relied on by said Bank pursuant to the authority granted herein prior to its receipt of such written notice shall be fully and conclusively binding on this corporation.

 

FURTHER RESOLVED, that the actions of any officer of this corporation heretofore taken in borrowing money from the Bank for and on behalf of this corporation, and in securing such indebtedness in any manner authorized herein, and in selling or assigning property of this corporation to the Bank with or without recourse, and in discounting with the Bank commercial and other business paper, be and the same hereby are in all respects ratified, confirmed and approved.

 

FURTHER RESOLVED, that in consideration of any loans or other financial accommodation made by the Bank to this corporation, this corporation shall be authorized to and shall assume full responsibility for and hold the Bank harmless from any and all payments made or any other actions taken by the Bank in reliance upon the signatures, including facsimiles thereof, of any person or persons holding the offices of this corporation designated above regardless of whether or not the use of the facsimile signature was unlawful or unauthorized and regardless of by whom or by what means the purported signature or facsimile signature may have been affixed to any instrument if such signatures reasonably resemble the specimen or facsimile signatures as provided to the Bank, or for refusing to honor any signatures not provided to the Bank; and that this corporation agrees to indemnify the Bank against any and all claims, demands, losses, costs, damages or expenses suffered or incurred by the Bank resulting from or arising out of any such payment or other action.  The foregoing indemnification shall be effective and may be enforced by the Bank upon delivery to the Bank of a copy of this resolution certified by the Secretary, Assistant Secretary or any other officer of this corporation.

 

FURTHER RESOLVED, that the Secretary, Assistant Secretary or any other officer of this corporation is authorized and directed to certify to the Bank the foregoing resolutions and that the provisions thereof are in conformity with the Articles of Incorporation and By-Laws of this corporation and to certify to the Bank the names of the persons now holding the offices referred to above and any changes hereafter in the persons holding said offices together with specimens of the signatures of such present and future officers.

 

FURTHER RESOLVED, that all prior resolutions of this corporation authorizing the borrowing of money from the Bank and the securing thereof, be and they hereby are rescinded and superseded as to all borrowings from the Bank and security transactions with respect thereto effected after the date of adoption of these resolutions.

 



 

I HEREBY CERTIFY that I am the duly elected, qualified and acting Secretary (or as otherwise designated below) and the custodian of the records of the above-named corporation, a corporation organized and existing and in good standing under the laws of the State of OREGON.  The foregoing resolutions (i) are true and correct copies of the resolutions duly adopted in accordance with law and the Charter or Articles or Certificate of Incorporation and By-Laws or Code of Regulations, as applicable, of the corporation and that such resolutions are now in full force and effect without modifications and are duly recorded in the minute book of the corporation or (ii) are otherwise in conformity with existing resolutions, the Charter or Articles or Certificate of Incorporation and By-Laws or Code of Regulations, as applicable, of the corporation, and permit the officers designated herein to undertake all the activities set forth above.

 

I FURTHER CERTIFY that set forth below are the true titles, names and genuine signatures of the duly elected or appointed, qualified and acting officers of said corporation presently holding such offices who are authorized under the foregoing resolutions:

 

Title

 

Name*

 

Signature*

 

 

 

 

Chairman of the Board

 

 

 

 

 

 

 

 

President

 

 

 

 

 

 

 

 

Vice President

 

 

 

 

 

 

 

 

 

 

 

 

 

Treasurer

 

 

 

 

 

 

 

 

Secretary

 

 

 

 

 

 

 

 

Assistant Treasurer

 

 

 

 

 

 

 

 

Assistant Secretary

 

 

 

 

 

 

 

 

 

 

MICHAEL A. TEMPLE

 

 

Other

 

EXECUTIVE VICE PRESIDENT

 

/s/ Michael A. Temple

 

 

Name & Title

 

 

 

 

 

 

Other

 

 

 

 

 

 

Name & Title

 

 

 

 

 

 

 

Other

 

 

 

 

 

 

Name & Title

 

 

 

 

 

 

 

Other

 

 

 

 

 

 

Name & Title

 

 

 

 

I FURTHER CERTIFY that copies of the Charter or Articles or Certificate of Incorporation and By-Laws or Code of Regulations, as applicable, of the corporation which have heretofore been delivered to the Bank or which are delivered herewith are true and correct copies and that such Charter or Articles or Certificate and By-Laws or Code of Regulations, as applicable, are presently in full force and effect.

 

IN WITNESS WHEREOF, I have affixed my name in my official capacity and have caused the corporate seal of the corporation to be hereunto affixed on                                             .

 

 

(CORPORATE SEAL)

 

 

 

 

 

 

 

 

 

 

/s/ [ILLEGIBLE]

 

Secretary

 


* Only the names and signatures of officers who will act in transactions with the Bank need be inserted.

 



 

CORPORATE RESOLUTION FOR GUARANTY AND PLEDGE OF ASSETS

 

BIOJECT INC.

CORPORATE NAME OF GUARANTOR

 

WHEREAS, BIOJECT MEDICAL TECHNOLOGIES INC., a OREGON Corporation (the “Borrower”) proposes to borrow from U.S. BANK N.A. (the “Bank”); and

 

WHEREAS, Bank has required as a condition of making such loans to Borrower that this corporation guarantee payment of such borrowing and of all present and future indebtedness, obligations and liabilities of Borrower to Bank; and

 

WHEREAS, this corporation is a parent corporation of the Borrower, does business with Borrower, leases assets from the Borrower or will otherwise derive a direct and substantial business benefit from the loans made to the Borrower by the Bank, the governing body of this corporation has determined that the guarantee of the Borrower’s obligations may reasonably be expected to benefit this corporation, and it is in the best interests of this corporation that the Borrower receive the loans from the Bank;

 

NOW, THEREFORE, RESOLVED, that any 1 of the officers of this corporation denoted below: [mark authorized officers]

 

o

Chairman of the Board

o

Treasurer

ý

Other: EXECUTIVE VICE PRESIDENT

o

President

o

Secretary

o

Other:

o

Any Vice President

o

Any Assistant Treasurer

o

Other:

 

 

o

Any Assistant Secretary

o

Other:

 

is (are) authorized and directed for and on behalf of and in the name of this corporation (a) to execute and deliver to the Bank a guaranty agreement pursuant to which the due and punctual payment of all Borrower’s present and future debts, obligations and liabilities to the Bank are guaranteed by this corporation and containing such other provisions including without limitation, waivers of notice, provisions releasing the Bank from any duties to perfect or realize on any collateral, and all such other provisions as the Bank may require and such officers approve; (b) to pledge, assign, mortgage or otherwise grant a security interest in any or all real property, fixtures, tangible or intangible personal property, or any other assets of this corporation, to execute, seal with the corporate seal, and deliver to the Bank such security agreements, chattel mortgages, assignments, financing statements, real estate mortgages, deeds of trust, lease or rental assignments, assignments of life insurance, agreements not to encumber or other agreements respecting any or all interests in real or personal property now owned or hereafter acquired by this corporation as may be requested by the Bank to secure any obligation of this corporation to the Bank or of the Borrower to the Bank, now existing or hereafter arising pursuant to such guaranty agreement or otherwise, all on such terms and conditions as said officer(s) shall approve, and to perform such acts required of this corporation in such agreements or otherwise to perfect such security interests; (c) to sell to the Bank, with or without recourse, accounts, contract rights, general intangibles, instruments, documents, chattel paper, equipment, inventory, insurance policies, deposit accounts, rights in action or other personal property of this corporation; (d) to endorse or assign and deliver such property to the Bank, and from time to time to withdraw and make substitutions of such property, or to sell such property to third persons and cause the proceeds of such sales to be applied against the obligations of this corporation to the Bank pursuant to the guaranty agreement or the obligations of the Borrower to the Bank; and (e) to give subordinations, guaranties, or other financial understandings to the Bank. The approval by such officer(s) shall be conclusively evidenced by (his/her) (their) execution of any such instrument described above.

 

FURTHER RESOLVED, that the authority granted to the officers of this corporation shall continue in full force and effect, and said Bank may rely thereon in dealing with such officers, unless and until written notice of any change in or revocation of such authority shall be delivered to said Bank to the attention of Commercial Loan Operations by an officer or director of this corporation, and any action taken by said officers and relied on by said Bank pursuant to the authority granted herein prior to its receipt of such written notice shall be fully and conclusively binding on this corporation.

 

FURTHER RESOLVED, that the actions of any officer of this corporation heretofore taken in guarantying the indebtedness of the Borrower to the Bank for and on behalf of this corporation, and in securing such guaranty in any manner authorized herein, and in selling or assigning property of this corporation to the Bank with or without recourse, be and the same hereby are in all respects ratified, confirmed and approved.

 

FURTHER RESOLVED, that in consideration of any loans or other financial accommodations made by the Bank to the Borrower or this corporation, this corporation shall be authorized and shall assume full responsibility and hold the Bank harmless from any and all payments made or any other actions taken by the Bank in reliance upon the signatures, including facsimiles thereof, of any person or persons holding the offices of this corporation designated above regardless of whether or not the use of the facsimile signature was unlawful or unauthorized and regardless of by whom or by what means the purported signature or facsimile signature may have been affixed to any instrument if such signatures reasonably resemble the specimen or facsimile signatures as provided to the Bank or for refusing to honor any signatures not provided to the Bank; and that this corporation agrees to indemnify the Bank against any and all claims, demands, losses, costs, damages or expenses suffered or incurred by the Bank resulting from or arising out of any such payment or other action. The foregoing indemnification shall be effective and may be enforced by the Bank upon delivery to the Bank of a copy of this resolution certified by the Secretary, Assistant Secretary or any other officer of this corporation.

 

FURTHER RESOLVED, that the Secretary or Assistant Secretary or any other officer of this corporation is authorized and directed to certify to the Bank the foregoing resolutions and that the provisions thereof are in conformity with the Articles of Incorporation or Bylaws of this corporation and to certify to the Bank the names of the persons now holding the offices referred to above and any changes hereafter in the persons holding said offices together with specimens of the signatures of such present and future officers.

 

(CONTINUED ON REVERSE SIDE)

 



 

I HEREBY CERTIFY that I am the duly elected, qualified and acting Secretary (or as otherwise designated below) and the custodian of the records of the above-named corporation, a corporation organized and existing and in good standing under the laws of the State of OREGON. The foregoing resolutions (i) are true and correct copies of the resolutions duly adopted in accordance with law and the Charter or Articles or Certificate of Incorporation and By-Laws or Code of Regulations, as applicable, of the corporation and that such resolutions are now in full force and effect without modifications and are duly recorded in the minute book of the corporation or (ii) are otherwise in conformity with existing resolutions, the Charter or Articles or Certificate of Incorporation and By-Laws or Code of Regulations, as applicable, of the corporation, and permit the officers designated herein to undertake all the activities set forth above.

 

I FURTHER CERTIFY that set forth below are the true titles, names and genuine signatures of the duly elected or appointed, qualified and acting officers of said corporation presently holding such offices who are authorized under the foregoing resolutions:

 

Title

 

Name*

 

Signature*

 

 

 

 

 

Chairman of the Board

 

 

 

 

 

 

 

 

 

President

 

 

 

 

 

 

 

 

 

Vice President

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Treasurer

 

 

 

 

 

 

 

 

 

Secretary

 

 

 

 

 

 

 

 

 

Assistant Treasurer

 

 

 

 

 

 

 

 

 

Assistant Secretary

 

 

 

 

 

 

 

 

 

 

 

MICHAEL A. TEMPLE

 

 

Other

 

EXECUTIVE VICE PRESIDENT

 

/s/ Michael A. Temple

 

 

 

Name & Title

 

 

 

 

 

 

 

Other

 

 

 

 

 

 

Name & Title

 

 

 

 

 

 

 

Other

 

 

 

 

 

 

Name & Title

 

 

 

 

 

 

 

Other

 

 

 

 

 

 

Name & Title

 

 

 

I FURTHER CERTIFY that copies of the Charter or Articles or Certificate of Incorporation and Bylaws or Code of Regulations, as applicable, of the corporation which have heretofore been delivered to the Bank or which are delivered herewith are true and correct copies and that such Charter or Articles or Certificate and Bylaws or Code of Regulations, as applicable, are presently in full force and effect.

 

IN WITNESS WHEREOF, I have affixed my name in my official capacity and have caused the corporate seal of the corporation to be hereunto affixed, on                                                  .

 

 

 

(CORPORATE SEAL)

 

 

 

 

 

 

 

 

 

 

/s/ [ILLEGIBLE]

 

Secretary

 


* Only the names and signatures of officers who will act in transactions with the Bank need be inserted.

 



 

COLLATERAL PLEDGE AGREEMENT

 

This Collateral Pledge Agreement (the “Agreement”) is made and entered into by the undersigned borrower, guarantor and/or other obligor/pledgor (the “Debtor”) in favor of U.S. BANK N. A. (the “Bank”) as of the date set forth on the last page of this Agreement.

 

ARTICLE I -  COLLATERAL PLEDGE; SECURITY INTEREST; DEFINITIONS

 

1.1  Grant of Security Interest/Collateral Pledge.  In consideration of any financial accommodation at any time granted by Bank to Debtor and/or BIOJECT MEDICAL TECHNOLOGIES INC. (the “Borrower”) and to secure the Obligations (as defined below) to Bank, Debtor hereby grants to Bank a security interest in and collaterally assigns to Bank the Collateral (defined below).  The intent of the parties hereto is that the Collateral secures all Obligations of Debtor and Borrower to Bank, whether or not such Obligations exist under this Agreement or any other agreements between Debtor and Bank (or Borrower and Bank), whether now or hereafter existing, including, without limitation, any note, any loan or security agreement, any lease, any mortgage, any deed of trust, any pledge of an interest in real or personal property, any guaranty, any letter of credit or banker’s acceptance, and any other agreement for services, financial accommodations or credit extended by Bank to Debtor and/or Borrower even though not specifically enumerated herein (together and individually, the “Loan Documents”).

 

1.2  “Collateral”  means all of the following property whether now owned or existing or hereafter acquired by Debtor (or by Debtor with spouse): investment property (including any securities entitlements and/or securities accounts held by Debtor); securities; certificates of deposit; instruments; notes; deposit accounts; monies; any other property in the possession of Bank or under the control of Bank (including any property held by a securities intermediary; or held by third parties as possessory agent for Bank) now or hereafter; letter of credit rights; all general intangibles related thereto; all renewals thereof, substitutions therefor; and all proceeds and supporting obligations thereof (such as stock splits, interest, dividends, profits and monies).

 

ý If box is checked, a further description of the Collateral continues on Exhibit A hereto.

 

1.3  “Obligations”  means all Debtor’s and Borrower’s debts (except for consumer credit if Debtor or Borrower is a natural person), liabilities, obligations, covenants, warranties and duties to Bank (plus its affiliates including any credit card debt, but specifically excluding any type of consumer credit), whether now or hereafter existing or incurred, whether liquidated or unliquidated, whether absolute or contingent, whether arising out of the Loan Documents or otherwise, and all other debts and obligations due Bank under any lease, agricultural, real estate or other financing transaction and regardless of whether such financing is related in time or type to the financing provided at the time of grant of this security interest, and regardless of whether such Obligations arise out of existing or future credit granted by Bank to any Debtor, to any Borrower, to any Debtor or any Borrower and others, to others guaranteed, endorsed or otherwise secured by any Debtor or any Borrower, or to any debtor-in-possession or other successor-in-interestof any Debtor or any Borrower and includes principal, interest, fees, expenses and charges relating to any of the foregoing.

 

1.4  Other Definitions.  Unless otherwise defined, the terms set forth in this Agreement shall have the meanings set forth in the Uniform Commercial Code as adopted in the Loan Documents and as amended from time to time.  The defined terms hereunder shall be interpreted in a manner most favorable to Bank.

 

ARTICLE II - WARRANTIES AND COVENANTS

 

In addition to all other warranties, representations and covenants in the Loan Documents which are expressly incorporated herein (except those dealing solely with Borrower described in the Loan Documents, if Debtor and Borrower are different entities) as part of this Agreement and while any part of the credit granted Debtor or Borrower under the Loan Documents is available or any Obligations of Debtor or Borrower to Bank are unpaid or outstanding, Debtor continuously warrants and agrees as follows:

 

2.1  Debtor’s Name, Location; Notice of Location Changes.  Except as indicated in the Article 9 Certificate executed by Debtor and made a part hereof, Debtor’s name and organizational structure have remained the same during the past five (5) years.  Debtor will continue to use only the name set forth with Debtor’s signature unless Debtor gives Bank prior written notice of any change.  Furthermore, Debtor shall not do business under another name nor use any trade name without giving ten (10) days prior written notice to Bank.  Debtor will not change its status or organizational structure without the prior written consent of Bank.  Debtor will not change its location or registration (if Debtor is a registered organization) to another state without prior written notice to Bank.  The address appearing in the Article 9 Certificate is Debtor’s chief executive office (or residence if Debtor is a sole proprietor).

 

2.2  Accuracy of Information/Verification.  All information, certificates and statements given to Bank pursuant to this Agreement will be accurate and complete when given.  Also, Bank may verify Collateral in any manner and Debtor shall assist Bank in so doing.

 

2.3  Organization and Authority.  The execution, delivery and performance of this Agreement and the other Loan Documents to which Debtor is a party: (i) are within Debtor’s power; (ii) have been duly authorized by proper corporate, partnership or limited liability company action (if applicable); (iii) do not require the approval of any governmental agency, other entity or person; and (iv) will not violate any law, agreement or restriction by which Debtor is bound.  This Agreement is the legal, valid and binding obligation of Debtor, and is enforceable against Debtor in accordance with its terms.

 

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2.4  Warranty of Title/Status of Collateral.  The Collateral is genuine and Debtor has good title to the Collateral.  The Collateral which evidences or constitutes third-party payment obligations to Debtor is fully enforceable in accordance with its terms, and not subject to dispute, setoff, adverse claims, defense, or adjustment by such third party (including any securities intermediary or issuer) except as permitted in writing by Bank.  Debtor will promptly provide Bank with written notice of anything that would impair the ability of any third-party obligor as to the Collateral from making payment to Debtor when due.  The Collateral is not subject to any restrictions on transfer and/or disposition by Debtor or Bank.  Debtor acknowledges that the Collateral constitutes “cash collateral” for purposes of 11 U.S.C. § 363.

 

2.5  Ownership; Maintenance of Collateral; Restriction on Liens and Dispositions.  Debtor is the sole owner of the Collateral free of all liens, claims, other encumbrances and security interests except as permitted in writing by Bank.  Debtor will: (i) maintain the Collateral, and not permit its value to be impaired; (ii) not permit waste, removal or loss of identity of the Collateral; (iii) keep the Collateral free from all liens, adverse claims, executions, attachments, claims, encumbrances and security interests (other than Bank’s sole and paramount security interest and those interests permitted in writing by Bank); (iv) defend the Collateral against all claims and legal proceedings by persons other than Bank; (v) pay and discharge when due all taxes, levies and other charges or fees which may be assessed against the Collateral (except for payment of taxes contested by Debtor in good faith by appropriate proceedings so long as no levy or lien has been imposed upon the Collateral); (vi) not sell or transfer the Collateral to any party; (vii) not permit the Collateral to be used or owned in violation of any applicable law, regulation or policy of insurance; (viii) preserve Bank’s rights and security interest in the Collateral against all other parties; and (ix) not make any instructions or entitlement orders which are contrary to the terms of this Agreement.  Debtor will promptly deliver to Bank a copy of any notices, statements or communications received by Debtor regarding the Collateral.

 

2.6  Maintenance of Security Interest.  Debtor will take any action requested by Bank to preserve the Collateral and to perfect, establish the priority of, continue perfection and enforce Bank’s interest in the Collateral and Bank’s rights under this Agreement (including the delivery of any stock or bond powers and endorsements deemed necessary by Bank); and Debtor will pay all costs and expenses related thereto.  Debtor shall also cooperate with Bank in obtaining control (for purposes of perfection under the Uniform Commercial Code) of Collateral consisting of deposit accounts, investment property, letter of credit rights, electronic chattel paper and any other collateral where Bank may obtain perfection through control.  Debtor hereby authorizes Bank to take any and all actions described above and in place of Debtor with respect to the Collateral and hereby ratifies any such actions Bank has taken prior to the date of this Agreement and hereafter, which actions may include, without limitation, filing UCC financing statements and obtaining or attempting to obtain control agreements from holders of the Collateral.

 

2.7  Insurance.  Debtor will be responsible for maintaining insurance on the Collateral covering such risks and with such insurers as is usual and customary; and Bank will not be responsible for insuring the Collateral.

 

2.8  Delivery of Collateral; Proceeds

 

(a)  Except as permitted in writing by Bank, all proceeds of, substitutions for and distributions regarding the Collateral received by Debtor will be held by Debtor in express trust for Bank, will not be commingled with any other funds or property of Debtor, and will be turned over to Bank in precisely the form received (but endorsed by Debtor, if necessary) not later than the business day following the day of their receipt by Debtor; and all proceeds of, substitutions for and distributions relating to the Collateral will be held by Bank as Collateral hereunder.

 

(b)  Notwithstanding the provisions of 2.8(a) above and absent a default hereunder, Debtor may retain all regularly scheduled and/or announced cash dividends or distributions paid to Debtor regarding the Collateral.

 

(c)  Debtor will immediately deliver in trust to Bank all original security certificates, safekeeping receipts and all other evidence of ownership and /or title to the Collateral (“Certificates”).  Furthermore, Debtor agrees to direct, in writing, that all banks and entities holding or controlling any Certificates promptly and directly transmit all such Certificates to Bank.

 

2.9  Possessory Agency Agreements; Control Agreements; Collateral in “Street Name”.  Upon the request of Bank, Debtor will promptly obtain from any entity holding or controlling any Collateral or Certificates such documents as Bank deems necessary to evidence its security interest in and exclusive possession of such Collateral and Certificates, including, without limitation, an exclusive possessory agency agreement or control agreement satisfactory to Bank; or as to any securities account(s) or security entitlement(s), nominate Bank as sole entitlement holder with respect thereto. Debtor agrees that Bank has control over all investment property pledged by Debtor and directs any securities intermediary (including Bank) and/or issuer to comply with any instructions or entitlement orders of Bank as to the Collateral without further consent of Debtor.  In the event Bank also acts in the capacity of a securities Intermediary with respect to the Collateral, this Agreement shall give Bank “control” of the Collateral, as that term is defined in the Uniform Commercial Code.  If any Collateral is not registered in Debtor’s legal name, Debtor will furnish Bank with satisfactory written proof of Debtor’s bonafide ownership of same.  Upon request of Bank, Debtor will have any Collateral registered in Debtor’s legal name at Debtor’s expense.

 

2.10  Book-Entry Government Securities; U.S. Savings Bonds.  As to any item of Collateral constituting a book-entry U.S. Government security held under the “treasury direct” system or any U.S. savings bond, such items of Collateral will not be deemed acceptable Collateral.

 

2.11  Tax Forms.  If requested by Bank, Debtor will complete and deliver to Bank IRS Form W-9 (Payer’s Request for Taxpayer Identification Number), or any successor form thereto, for each item of Collateral pledged to Bank and any other informational tax filings required by federal and state taxing authorities with regard to the Collateral.

 

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2.12  Minimum Collateral Coverage; Acceptable Collateral.  At all times, Debtor will maintain with Bank acceptable Collateral having a market value (as determined by Bank) equal to N/A% of the then outstanding principal amount of the Obligations (the “Minimum Collateral Coverage”).  In the event Debtor fails to maintain the Minimum Collateral Coverage, Debtor will deliver to Bank additional acceptable Collateral necessary to restore the Minimum Collateral Coverage upon five (5) business days prior written notice from Bank, or Bank may declare Debtor in default hereunder.

 

2.13 Regulation U Forms.  If any Collateral is “margin stock” under Regulation U of the Federal Reserve Board, Debtor will deliver to Bank a completed Form U-I satisfactory to Bank upon request.

 

2.14 Holding Periods.  If any of the Collateral constituting a “security” under any federal securities laws (“Securities Collateral”) does not qualify under SEC Rule 144[k] as being held for two (2) years in the hands of Bank at any time, such Securities Collateral will not be deemed to qualify as acceptable Collateral hereunder unless agreed to in writing by Bank (and Bank may require Debtor to provide Bank with Securities Collateral which will meet such qualifications under SEC Rule 144[k]).  Debtor will promptly furnish to Bank such information as Bank deems necessary to comply with federal and/or state securities laws as to the holding and disposition of any Collateral, and to determine the status of the Collateral under federal and/or state securities laws (including, without limitation, an opinion of counsel as to the status of the Collateral under federal and state securities laws); all in form satisfactory to Bank and at Debtor’s expense.

 

ARTICLE III - RIGHTS AND DUTIES OF BANK

 

In addition to all other rights (including setoff) of Bank under the Loan Documents which are expressly incorporated herein as a part of this Agreement, the following provisions will also apply:

 

3.1 Authority to Perform for Debtor/Entitlement Holder.  To facilitate Bank’s ability to preserve and dispose of the Collateral, Debtor unconditionally appoints any officer of Bank as Debtor’s attorney-in-fact (coupled with an interest and irrevocable while any Obligations remain unpaid) to do any of the following upon default by Debtor hereunder (notwithstanding any notice requirements or grace/cure periods under this or any other agreements between Debtor and Bank): to file, endorse the name of Debtor on any Collateral, financing statements, checks, drafts, money orders and insurance claims or payments, and any documents needed to perfect, protect and/or realize upon Bank’s interest in the Collateral; to nominate itself as entitlement holder as to any or all of the Collateral; and to do all such other acts and things necessary to carry out Debtor’s obligations under this Agreement and the other Loan Documents.  All acts taken by Bank pursuant to the above-described authority are hereby ratified and approved, and Bank will not be liable to Debtor for any acts of commission or omission, nor for any errors of judgment or mistakes in undertaking such actions except for Bank’s willful misconduct.  For good and valuable consideration, Debtor agrees not to assert any claims against any third-party (including any issuer or any securities intermediary) holding Collateral for complying with Bank’s requests hereunder, and Debtor waives any claims against such third parties for actions taken at the request of Bank.

 

3.2 Collateral Preservation.  Bank will use reasonable care as to any Collateral in its physical possession but in determining such standard of reasonable care, Debtor expressly acknowledges that Bank has no duty to: (i) insure the Collateral against hazards; (ii) protect the Collateral from seizure, levy, lien, claim or conversion by third parties, or acts of God; (iii) give to Debtor any notices, account statements, proxies or communications received by Bank regarding the Collateral; (iv) perfect or continue perfection of any security interest in the Collateral in favor of Debtor; (v) inform Debtor of any decline in the value of the Collateral or the existence of any option or elections with respect to the Collateral; (vi) take any action to invest or manage the Collateral; (vii) exercise, preserve or notify Debtor with respect to any exchanges, puts, calls, redemptions, conversions, maturities, offers, tenders and other rights or requirements regarding the Collateral or Debtor’s interest therein; or (viii) sue or otherwise take action to preserve Debtor’s or Bank’s interest in the Collateral.  Notwithstanding any failure by Bank to use reasonable care in preserving the Collateral, Debtor agrees that Bank will not be liable to Debtor for consequential or special damages arising from such failure.  The foregoing also apply if Bank is deemed entitlement holder as to any Collateral.

 

3.3 Setoff.  As additional security for the payment of the Obligations, Debtor hereby grants to Bank a security interest in, a lien on and an express contractual right to set off against all depository account balances, cash and any other property of Debtor now or hereafter in the possession of Bank and the right to refuse to allow withdrawals from any account (collectively “Setoff”).  Bank may, at any time upon the occurrence of a default hereunder (notwithstanding any notice requirements or grace/cure periods under this or other agreements between Debtor or Borrower and Bank), Setoff against the Obligations whether or not the Obligations (including future installments) are then due or have been accelerated, all without any advance or contemporaneous notice or demand of any kind to Debtor, such notice and demand being expressly waived.

 

ARTICLE IV - DEFAULTS AND REMEDIES

 

4.1  Defaults.  Notwithstanding any cure periods described below, Debtor will immediately notify Bank in writing when Debtor obtains knowledge of the occurrence of any default specified in this Agreement or any of the other Loan Documents.  A default shall occur hereunder if Debtor and/or Borrower fails to comply with the terms of any Loan Documents (including this Agreement or any guaranty by Debtor), a demand for payment is made under a demand loan, or any other obligor fails to comply with the terms of any Loan Documents for which Debtor has given Bank a guaranty or pledge.

 

4.2  Termination of Loans; Additional Bank Rights. Upon the occurrence of any of the events identified in Section 4.1, Bank may at any time (notwithstanding any notice requirements or grace/cure periods under this or other agreements between Debtor or Borrower and Bank): (i) immediately terminate its obligation, if any, to make additional loans to Debtor and/or Borrower; (ii) Setoff; and/or (iii) take

 

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such other steps to protect or preserve Bank’s interest in the Collateral; all without demand or further notice of any kind, all of which are hereby waived.  In addition to Bank’s other rights, Debtor irrevocably appoints Bank as attorney-in-fact, with full power of substitution and revocation, to exercise Debtor’s rights to take any action respecting the Collateral or with regard to any issuer or transfer agent of the Collateral thereof as fully as Debtor might do.  This proxy remains effective so long as any of the Obligations are unpaid.

 

4.3  Acceleration of Obligations.  Upon the occurrence of an event of default as provided in Section 4.1 above and the passage of any applicable cure periods, Bank may at any time thereafter, by written notice to Debtor, declare the unpaid principal balance of any Obligations, together with the interest accrued thereon and other amounts accrued hereunder and under the other Loan Documents, to be immediately due and payable; and the unpaid balance will thereupon be due and payable, all without presentation, demand, protest or further notice of any kind, all of which are hereby waived, and notwithstanding anything to the contrary contained herein or in any of the other Loan Documents.  Notwithstanding the above, to the extent any of the Obligations referred to herein are payable upon demand, nothing herein will restrict nor negate the demand nature of such Obligations.  Nothing contained in Article IV will limit Bank’s right to Setoff as provided in Sections 3.3 and 4.2.

 

4.4  Remedies.  After maturity of any of the Obligations, or a default hereunder or under any of the other Loan Documents, and without notice or demand of any kind, Bank may: (i) transfer any of the Collateral into its name or that of its nominee, or deem itself to be entitlement holder as to any Collateral without notice to or consent of Debtor; (ii) in Debtor’s name or otherwise dispose of and/or collect any Collateral by suit or otherwise; or surrender or exchange all or any part of the Collateral; or compromise, extend, renew or modify any obligation evidenced by the Collateral; (iii) exercise all of Debtor’s rights as an entitlement holder and/or owner of the Collateral; (iv) dispose of the Collateral as provided for herein and at law; and (v) notify any issuer, transfer agent or securities intermediary, or holder of any Collateral or Certificates of this pledge of the Collateral, and direct such issuer, transfer agent or securities intermediary to comply with all instructions and entitlement orders originated by Bank without further consent of Debtor, and/or deliver directly in trust to Bank any Collateral, Certificates and subsequent shares of stock, dividend payments or other distributions pertaining to the Collateral or arising from Debtor’s ownership of the Collateral; and in each case Debtor hereby unconditionally directs such parties to comply with Bank’s requests in all respects.

 

4.5  Cumulative Remedies; Notice; Waiver. In addition to the remedies set forth herein, Bank will have all other rights and remedies for default provided by the Uniform Commercial Code, as well as any other applicable law, INCLUDING, WITHOUT LIMITATION, THE RIGHT TO REPOSSESS AND DISPOSE OF THE COLLATERAL WITHOUT JUDICIAL PROCESS.  The rights and remedies specified herein are cumulative and are not exclusive of any rights or remedies which Bank would otherwise have.  With respect to such rights and remedies:

 

(a)  Notice of Disposition. Written notice, when required by law, sent to any address of Debtor in this Agreement or otherwise provided to Bank, at least five (5) calendar days (counting the day of sending) before the date of a proposed disposition of the Collateral will be deemed reasonable notice but less notice may be reasonable under the circumstances;

 

(b)  Possession of Collateral/Commercial Reasonableness.  Bank shall not, at any time, be obligated to either take or retain possession or control of the Collateral.  With respect to Collateral in the possession or control of Bank, Debtor and Bank agree that as a standard for determining commercial reasonableness, (and in addition to the provisions of Section 3.2 above) Bank need not liquidate, collect, sell or otherwise dispose of any of the Collateral if Bank believes, in good faith, that disposition of the Collateral would not be commercially reasonable, would subject Bank to third-party claims or liability, would cause Bank to violate federal or state securities laws, that other potential purchasers could be attracted or that a better price could be obtained if Bank held the Collateral for up to 2 years.  Bank may sell Collateral without giving any warranties and may specifically disclaim any warranties of title or the like.  Furthermore, Bank may sell the Collateral on credit (and reduce the Obligations only when payment is received from the buyer), at wholesale and/or with or without an agent or broker; Bank need not register any securities collateral under state or federal law; and Bank need not complete, process, or otherwise prepare the Collateral prior to disposition.  If the purchaser fails to pay for the Collateral, Bank may resell the Collateral and Debtor shall be credited with the cash proceeds of the sale.  Bank may comply with any applicable state or federal law requirements in connection with a disposition of the Collateral and compliance will not be considered to adversely affect the commercial reasonableness of any sale of the Collateral.

 

(c)  Waiver by Debtor.  Bank has no obligation and Debtor waives any obligation to attempt to satisfy the Obligations by collecting the obligations from any third parties and Bank may release, modify or waive any collateral provided by any third party to secure any of the Obligations, all without affecting Bank’s rights against Debtor.  Debtor further waives any obligation on the part of Bank to marshal any assets in favor of Debtor or in payment of the Obligations.  Notwithstanding any provisions in this Agreement or any other agreement between Debtor and Bank, Debtor does not waive any statutory rights except to the extent that the waiver thereof is permitted by law.

 

(d)  Waiver by Bank.  Bank may permit Debtor to attempt to remedy any default without waiving its rights and remedies hereunder, and Bank may waive any default without waiving any other subsequent or prior default by Debtor.  Furthermore, delay on the part of Bank in exercising any right, power or privilege hereunder or at law will not operate as a waiver thereof, nor will any single or partial exercise of such right, power or privilege preclude other exercise thereof or the exercise of any other right, power or privilege.  No waiver or suspension will be deemed to have occurred unless Bank has expressly agreed in writing to such waiver or suspension.

 

ARTICLE V - MISCELLANEOUS

 

5.1  Relationship to Other Documents.  The warranties, representations, covenants and duties of Debtor (and the rights and remedies of Bank) that are outlined in this Agreement and the other Loan Documents are intended to supplement each other.  In the

 

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event of any inconsistencies between the terms in the Loan Documents and this Agreement, all such inconsistencies will be construed so as to give Bank the most favorable rights.  Furthermore, Debtor and Bank waive any presumption or rule requiring construction of this Agreement against the drafter.

 

5.2  Notices.  Notice of any record shall be deemed delivered when the record has been (a) deposited in the United States Mail, postage pre-paid, (b) received by overnight delivery service, (c) received by telex, (d) received by telecopy, (e) received through the internet, or (f) when personally delivered.

 

5.3  Nature of Liability/Successors.  The rights, powers and remedies granted in this Agreement to Bank will extend to Bank’s successors, Participants (as defined below) and assigns, and the provisions of this Agreement will be binding upon Debtor and its successors and assigns.  All Debtors are jointly and severally liable under this Agreement.

 

5.4  Expenses and Attorneys’ Fees.  Debtor will reimburse Bank and any participant in the Loan Documents (the “Participant)’ for all fees and out-of-pocket disbursements incurred by Bank and any Participant in connection with: preparation of this Agreement; perfecting, establishing and confirming the priority of Bank’s security interest in the Collateral; any confirmations, audits or appraisals of Debtor’s business operations and the Collateral; the amendment, administration, defense and enforcement of this Agreement or of any of the other Loan Documents, and any waivers with respect thereto.  Debtor also will reimburse Bank and any Participant for all costs of collection, including all attorneys’ fees, before and after judgment, and all costs of preservation and/or liquidation of the Collateral.

 

5.5  Applicable Law and Jurisdiction; Interpretation and Modification.  This Agreement and all other Loan Documents will be governed by and interpreted in accordance with the laws of the State of OREGON.  Invalidity of any provision of this Agreement will not affect the validity of any other provision.  The provisions of this Agreement and the other Loan Documents will not be altered, amended or waived without the express written consent of Bank (and Debtor, when appropriate).  DEBTOR HEREBY CONSENTS TO THE EXCLUSIVE JURISDICTION OF ANY STATE OR FEDERAL COURT SITUATED IN THE COUNTY OR FEDERAL JURISDICTION OF BANK’S BRANCH WHERE THE LOAN WAS ORIGINATED, AND WAIVES ANY OBJECTION BASED ON FORUM NON CONVENIENS, WITH REGARD TO ANY ACTIONS, CLAIMS, DISPUTES OR PROCEEDINGS RELATING TO THIS AGREEMENT, THE COLLATERAL, ANY OTHER LOAN DOCUMENT, OR ANY TRANSACTIONS ARISING THEREFROM, OR ENFORCEMENT AND/OR INTERPRETATION OF ANY OF THE FOREGOING.  Nothing herein will affect Bank’s rights to serve process in any manner permitted by law, or limit Bank’s right to bring proceedings against Debtor in the competent courts of any other jurisdiction or jurisdictions.  This Agreement and any amendments hereto (regardless of when executed) will be deemed effective and accepted only at Bank’s main office, and only upon Bank’s receipt of the executed originals thereof.

 

5.6  Copies; Entire Agreement; Modification.  Debtor hereby acknowledges the receipt of a copy of this Agreement and the other Loan Documents.

 

IMPORTANT: READ BEFORE SIGNING.  THE TERMS OF THIS AGREEMENT SHOULD BE READ CAREFULLY BECAUSE ONLY THOSE TERMS IN WRITING, EXPRESSING CONSIDERATION AND SIGNED BY THE PARTIES ARE ENFORCEABLE.  NO OTHER TERMS OR ORAL PROMISES NOT CONTAINED IN THIS WRITTEN CONTRACT MAY BE LEGALLY ENFORCED.  DEBTOR AND BANK MAY CHANGE THE TERMS OF THIS AGREEMENT ONLY BY ANOTHER WRITTEN AGREEMENT.  THIS NOTICE WILL ALSO BE EFFECTIVE WITH RESPECT TO ALL OTHER LOAN DOCUMENTS NOW IN EFFECT BETWEEN DEBTOR AND/OR BORROWER AND BANK.  A MODIFICATION OF ANY OTHER LOAN DOCUMENTS NOW IN EFFECT BETWEEN DEBTOR AND/OR BORROWER AND BANK, WHICH OCCURS AFTER RECEIPT BY DEBTOR OF THIS NOTICE, MAY BE MADE ONLY BY ANOTHER WRITTEN INSTRUMENT.  ORAL OR IMPLIED MODIFICATIONS TO SUCH LOAN DOCUMENTS ARE NOT ENFORCEABLE AND SHOULD NOT BE RELIED UPON.

 

5.7  Waiver of Jury Trial.  DEBTOR AND BANK HEREBY JOINTLY AND SEVERALLY WAIVE ANY AND ALL RIGHT TO TRIAL BY JURY IN ANY ACTION OR PROCEEDING RELATING TO ANY OF THE LOAN DOCUMENTS, THIS AGREEMENT, THE OBLIGATIONS THEREUNDER, THE COLLATERAL OR ANY TRANSACTION ARISING THEREFROM OR CONNECTED THERETO.  DEBTOR AND BANK EACH REPRESENTS TO THE OTHER THAT THIS WAIVER IS KNOWINGLY, WILLINGLY AND VOLUNTARILY GIVEN.

 

5.8  Attachments.  All documents attached hereto, including any appendices, schedules, riders, and exhibits to this Agreement, are hereby expressly incorporated by reference.

 

 

[SIGNATURE(S) ON NEXT PAGE]

 

5



 

IN WITNESS WHEREOF, the undersigned has/have executed this Collateral Pledge Agreement as of NOVEMBER 25, 2003.

 

 

 

BIOJECT INC.

(INDIVIDUAL DEBTOR)

 

Debtor Name (Organization)

 

 

 

 

 

 

 

(Seal)

a

OREGON Corporation

 

 

 

Debtor Name

N/A

 

By

/s/ Michael A. Temple

 

 

 

 

 

Name and Title

MICHAEL A. TEMPLE, EXECUTIVE VICE PRESIDENT

 

(Seal)

 

 

 

By

 

Debtor Name

N/A

 

 

 

 

Name and Title

 

 

6



 

EXHIBIT A

 

DATED:  NOVEMBER 25, 2003

 

Description of Collateral
(CDs, Notes, Bonds, etc.)

 

Identification No./Renewal-Expiry Date

 

 

 

U.S. BANK N.A. MONEY CENTER

 

ACCOUNT  # 436000047

 

 

 

 

 

 

 

 

 

 

 

 

 

Attach copy of each certificate, safekeeping receipt, bond, stock certificate, etc., identified above.

 



 

LIMITED RECOURSE AGREEMENT

(Must be accompanied by Business Security Agreement,

Collateral Pledge Agreement or Mortgage/Deed of Trust)

 

1.  Pledge of Collateral.  For value received,  and to induce U.S. BANK N.A. (the “Bank”) to extend credit or other financial accommodations now or in the future to BIOJECT MEDICAL TECHNOLOGIES INC. (the “Borrower”), the undersigned (the “Pledgor”) hereby unconditionally jointly and severally pledges the collateral described below to secure payment of the Obligations (as hereinafter defined).  Notwithstanding the provisions of any separate security agreement or mortgage/deed of trust, the Bank may immediately exercise its rights to realize upon the Collateral (as hereinafter defined) whenever the Obligations become due, whether on demand, at maturity, by reason of acceleration or if the Pledgor becomes the subject of any bankruptcy or insolvency proceeding, and whether or not the Obligations are valid and enforceable against the Borrower.

 

As used herein, the term “Obligations” shall mean all loans, drafts, overdrafts, checks, notes and all other debts, liabilities and obligations of every kind owing by the Borrower to the Bank, whether direct or indirect, absolute or contingent, liquidated or unliquidated whether of the same or a different nature and whether existing now or in the future, including interest thereon; and all costs, expenses and attorneys’ fees paid or incurred by the Bank at any time before or after judgment in attempting to collect any of the foregoing, to realize on any collateral securing any of the foregoing or this Agreement, and to enforce this Agreement, whether such costs, expenses or fees are incurred before or after commencement of litigation or at trial, on appeal, or in any other proceeding.  The definition of “Obligations” also includes the amount of any payments made to the Bank or another on behalf of the Borrower (including payments resulting from liquidation of collateral) which are recovered from the Bank by a trustee, receiver, creditor or other party pursuant to applicable Federal or state law (the “Surrendered Payments”).  In the event that the Bank makes any Surrendered Payments (including pursuant to a negotiated settlement), the Surrendered Payments shall immediately be reinstated as Obligations, regardless of whether the Bank has surrendered or canceled this Agreement prior to returning the Surrendered Payments.

 

2.  Collateral Pledged.  To secure prompt payment of the Obligations, the Pledgor hereby grants the Bank a mortgage/deed of trust and security interest in the real estate, personal property and other collateral (the “Collateral”) described in the collateral documents executed by the Pledgor in favor of the Bank whether presently existing or executed in the future, including but not limited to the following documents [check all that apply]:o Security Agreement ý Collateral Pledge Agreement  o Mortgage/Deed of Trust o Other                           (the “Collateral Documents”).

 

3.  No Personal Liability.  The Pledgor has no personal liability under this Agreement, except as outlined in this paragraph.  In the event that the Bank is entitled to proceed against the Pledgor under the terms of this Agreement, the Bank’s sole recourse shall be against the Collateral, except to the extent that the Bank suffers a loss or damage as a result of the willful misconduct of the Pledgor, or the Pledgor’s failure to comply with the terms of this Agreement or any Collateral Documents (collectively “Misconduct”).

 

4.  Consent to Bank Actions; No Discharge; Financial Condition.  The Pledgor agrees that the Bank does not have to take any steps whatsoever to proceed against the Borrower or any other pledgor, guarantor, surety or other collateral for the Obligations either before or after proceeding against the Pledgor’s Collateral; and the Pledgor waives any claim of marshalling of assets against the Bank or any Collateral.  The Pledgor also agrees that the Bank may do or refrain from doing any of the following without notice to, or the consent of, the Pledgor, without reducing or discharging the Pledgor’s liability under this Agreement:  (i) renew, amend, extend, waive or release any Obligations and/or any documents related thereto, and make additional extensions of credit to the Borrower; (ii) settle, modify, release, compromise or subordinate any Obligation, any collateral securing any Obligation or this Agreement; (iii) apply payments on the Obligations in any manner that the Bank elects; (iv) fail or delay in perfecting (or to continue perfection of) any security interest, mortgage/deed of trust or other lien on any collateral securing the Obligations or this Agreement,  or to fail to protect the value or condition of any such collateral; or (v) fail to advise the Pledgor of the Borrower’s financial condition (the Pledgor specifically acknowledging that the Pledgor has examined the Borrower’s books and financial condition to the extent Pledgor deems necessary and that the Pledgor has not relied upon nor will rely upon representations, if any, by the Bank as to the Borrower’s financial condition).

 

5.  Waivers.  The Pledgor expressly waives all rights of setoff and counterclaims, as well as diligence in collection or prosecution, presentment, demand of payment or performance, protest, notice of dishonor, nonpayment or nonperformance of any Obligation.  The Pledgor also expressly waives notice of acceptance of this Agreement, and the right to receive all other notices and demands of any kind relating to the Obligations or this Agreement.  The Pledgor agrees that any right of subrogation as to payment or enforcement of any security interest securing the Obligations should not be enforceable by any Pledgor until the Bank is paid in full.

 

1



 

6.  Duration of Agreement; Revocation; Continuing Obligations.  This is a continuing pledge and shall not be revoked by death, dissolution, merger, bankruptcy, incompetency or insolvency of the Pledgor.  This Agreement shall remain in full force and effect with respect to the Pledgor until the Bank receives written notice from the Pledgor revoking this Agreement as to the Pledgor.  In the event that this Agreement is revoked by the Pledgor, said revocation shall have no effect on the continuing pledge of the Collateral to secure unconditionally the prompt payment of all Obligations which are contracted or incurred before the revocation becomes effective, including such prior Obligations which are subsequently renewed, modified or extended after the revocation becomes effective, as well as all extensions of credit made after revocation pursuant to commitments made prior to such revocation.

 

7.  Acceleration of Obligations; Successors; Multiple Pledgors.  If the Pledgor shall die, become the subject of any incompetency proceedings, become the subject of any bankruptcy or insolvency proceedings, or fail to comply with the terms of this Agreement, the Collateral Documents, or any related document, the Bank shall have the immediate right to liquidate the Collateral to pay the Obligations whether or not the Obligations are then due and payable by the Borrower or any other third party.  This Agreement shall inure to the benefit of the Bank, its successors and assigns and of the holder and owner of any of the Obligations, and shall be binding on heirs, executors, administrators, successors and assigns of the Pledgor.  If there is more than one Pledgor, the liability of the Pledgors shall be joint and several, and the reference to the “Pledgor” shall be deemed to refer to all Pledgors.

 

8.  Copies; Entire Agreement; Modification.  The Pledgor hereby acknowledges the receipt of a copy of this Agreement.

 

IMPORTANT: READ BEFORE SIGNING.  THE TERMS OF THIS AGREEMENT SHOULD BE READ CAREFULLY BECAUSE ONLY THOSE TERMS IN WRITING, EXPRESSING CONSIDERATION AND SIGNED BY THE PARTIES ARE ENFORCEABLE. NO OTHER TERMS OR ORAL PROMISES NOT CONTAINED IN THIS WRITTEN CONTRACT MAY BE LEGALLY ENFORCED.  THE TERMS OF THIS AGREEMENT MAY ONLY BE CHANGED BY ANOTHER WRITTEN AGREEMENT.

 

9.  Governing Law; Jurisdiction. This Agreement shall be governed by the laws of the State of OREGON, except to the extent superseded by Federal law. THE PLEDGOR HEREBY CONSENTS TO THE EXCLUSIVE JURISDICTION OF ANY STATE OR FEDERAL COURT SITUATED IN THE COUNTY OR FEDERAL JURISDICTION OF THE BANK’S BRANCH WHERE THE LOAN WAS ORIGINATED, AND WAIVES ANY OBJECTION BASED ON FORUM NON CONVENIENS, WITH REGARD TO ANY ACTIONS, CLAIMS, DISPUTES, OR PROCEEDINGS RELATING TO THIS AGREEMENT, THE COLLATERAL, ANY RELATED DOCUMENT, OR ANY TRANSACTIONS ARISING THEREFROM, OR ENFORCEMENT AND/OR INTERPRETATION OF ANY OF THE FOREGOING. Nothing herein shall affect the Bank’s right to serve process in any manner permitted by law, or limit the Bank’s right to bring proceedings against the Pledgor in the competent courts of any other jurisdiction or jurisdictions.

 

10.  Waiver of Jury Trial.  THE PLEDGOR AND THE BANK HEREBY JOINTLY AND SEVERALLY WAIVE ANY AND ALL RIGHT TO TRIAL BY JURY IN ANY ACTION OR PROCEEDING RELATING TO THIS AGREEMENT, ALL DOCUMENTS RELATING TO THIS AGREEMENT, THE OBLIGATIONS HEREUNDER OR ANY TRANSACTION ARISING HEREFROM OR CONNECTED HERETO.  THE PLEDGOR AND THE BANK EACH REPRESENTS TO THE OTHER THAT THIS WAIVER IS KNOWINGLY, WILLINGLY AND VOLUNTARILY GIVEN.

 

Dated:

  NOVEMBER 25, 2003

 

 

 

 

 

 

 

 

 

BIOJECT INC.

 

 

Pledgor Name (Corporation or Partnership)

(Individual Pledgor)

 

 

 

 

 

 

 

(SEAL)

a

OREGON Corporation

 

 

 

 

Pledgor Name

N/A

 

By

/s/ Michael A. Temple

 

 

 

 

 

(SEAL)

Name and Title

MICHAEL A. TEMPLE, EXECUTIVE VICE PRESIDENT

 

 

 

 

Pledgor Name

N/A

 

By

 

 

 

 

 

 

 

Name and Title

 

 

2


EX-10.31.1 4 a04-1725_1ex10d31d1.htm EX-10.31.1

Exhibit 10.31.1

 

U.S. Bank

 

Commercial Banking

111 SW Fifth Avenue

Suite 400

Portland, OR 97204

 

 

February 13, 2004

 

 

Bioject Medical Technologies, Inc.

Attn: Chris Farrell

7620 SW Bridgeport Rd.

Portland, OR 97224

 

Dear Chris,

 

Per your request, the following description outlines Bioject Medical Technologies Inc.’s credit facility with U.S. Bank, N.A.

 

As executed on December 2, 2003, Bioject’s credit facility is a $1,500,000.00 non-revolving commitment, which has a 6-month interest only drawdown period (period expires on May 31, 2004), after which the facility coverts to a term loan.  At the time of conversion, the term loan with have a 60 month maturity and 60 month amortization with a fixed rate to be locked on or before May 31, 2004.  The rate will be locked at US Bank’s “60 month maturity/60 month amortization” cost of funds, plus 2.25%, and principal and interest will then be due on a monthly basis.  For the entire term of the loan, a pledged US Bank Certificate of Deposit from Bioject, Inc. will be held as collateral.

 

As we discussed, Bioject Medical Technologies has some flexibility as to when you wish to terminate the interest only period of your credit facility.  Seeing as how the full amount of your availability has been advanced, US Bank can begin the term-out portion of the note at any time, with the conversion not to occur after May 31, 2004.

 

If you have any questions, please feel free to give us a call at any time.

 

 

Sincerely,

 

 

/s/ Elizabeth Jones

 

/s/ Mark Stuart

 

Elizabeth Jones

Mark Stuart

Relationship Manager

Vice President

503-275-4282

503-275-5268

 


EX-14 5 a04-1725_1ex14.htm EX-14

EXHIBIT 14

 

BIOJECT MEDICAL TECHNOLOGIES INC.
Code of Business Conduct and Ethics

 

This Code of Business Conduct and Ethics covers basic principles to guide all Bioject officers, directors, and employees, as well as representatives, consultants and agents in their dealings with or on behalf of Bioject.  If you violate the standards in this Code, you will be subject to disciplinary action up to and including termination of employment.

 

If you or someone you know are in a situation which you believe may violate or lead to a violation of this Code, please follow the guidelines described in Article VII.

 

ARTICLE I
HONESTY, ACCURACY, AND FAIR DEALING

 

You should act in good faith, responsibly, with due care, competence and diligence, without misrepresentation.  Bioject’s books, records, accounts and financial statements must accurately reflect transactions and relevant matters, and must conform both to legal requirements and to Bioject’s system of internal controls.

 

You should deal fairly and honestly with Bioject’s customers, suppliers, competitors and other team members.  You should not steal proprietary information, possess trade secret information that was obtained without the owner’s consent, or induce disclosures of such information from past or present employees of other companies, nor should you take unfair advantage of anyone through misrepresentation, fraud, abuse of privileged information or any other unfair dealing practice.

 

ARTICLE II
COMPLIANCE WITH LAWS, RULES AND REGULATIONS

 

You must respect and obey the local, state, and national laws of the localities in which we operate.  We encourage you to consult regularly with your supervisor regarding your compliance with laws, rules and regulations.

 

The U.S. Foreign Corrupt Practices Act prohibits giving anything of value, directly or indirectly, to officials of foreign governments or foreign political candidates in order to obtain or retain business.  It is prohibited to make illegal payments to government officials of any country.

 

As a Bioject team member, you may have access to confidential information about Bioject or companies with which we do business.  You are not permitted to use or share that information for stock trading purposes or for any other purpose except the conduct of our business.  To use confidential information for personal benefit or to “tip” others who might use the information for personal benefit or to make an investment decision is not only unethical but also illegal.  It is important to avoid even the appearance of impropriety.

 

1



 

ARTICLE III
CONFLICTS OF INTEREST, CORPORATE OPPORTUNITIES, AND GIFTS

 

A “conflict of interest” exists when a person’s private interest interferes with the interests of Bioject.  Conflicts of interest may also arise when you or members of your family receive improper personal benefits as a result of your position with Bioject.  Loans to, or guarantees of obligations of, you or your family members may create conflicts of interest.  Conflicts of interest may not always be clear-cut, so if you have a question, you should follow the guidelines described in Article VII.

 

You must not take for yourself an opportunity discovered through the use of Bioject property, information or position.  You may not use Bioject property, information or position for improper personal gain, nor may you compete with Bioject directly or indirectly.  You owe a duty to Bioject to advance its legitimate interests when the opportunity arises.

 

Although Bioject generally relies on your good judgment when it comes to gifts, you are specifically prohibited from (a) accepting gifts for relatives, friends or other associates, or (b) accepting a cash gift at any time.  If you receive a non-cash gift with a value in excess of two hundred fifty U.S. dollars ($250.00), or if you are in doubt about the value of a gift, you should report it to Bioject’s Finance Department.  Non-cash gifts may include benefits that you do not routinely think of as a “gift,” such as trips, concert or other event tickets, or social outings.  You may be required to turn over any such gifts to Bioject.

 

ARTICLE IV
PROTECTION AND PROPER USE OF BIOJECT RESOURCES

 

You are responsible for protecting Bioject’s assets.  Any suspected fraud, theft or misuse of Bioject assets should be immediately reported to Bioject in accordance with the guidelines described in Article VII.  Your obligation to protect Bioject’s assets extends to Bioject’s property, products, and intellectual property including trademarks, trade secrets, patents, and copyrights, as well as business, marketing and service plans, manufacturing ideas, designs, records, and any unpublished data and reports.

 

Unless disclosure is authorized by Bioject or required by law or regulation, you must hold and maintain confidential information in trust and confidence for the benefit of Bioject and take reasonable security precautions and other actions necessary to ensure that there is no use or disclosure of confidential information in violation of these obligations.  Confidential information includes all information relating to Bioject that is not publicly available or that is treated by Bioject as confidential, as well as all information provided to Bioject by a customer or other third party with an expectation of confidentiality.

 

2



 

ARTICLE V
PUBLIC DISCLOSURES

 

As a publicly traded company, Bioject is subject to laws and regulations that govern how and when we disclose information.  Only Bioject’s Chief Executive Officer, Chief Financial Officer, and a person authorized by one of them, is permitted to speak with investors or investment analysts about Bioject, or to speak with the media about matters involving Bioject’s financial condition, results of operations, future business prospects, or similar topics.  General media relations should be coordinated by Bioject’s Investor Relations Department.  You should always refer news reporters, stock analysts or others seeking information about Bioject to one of the individuals listed above or to Bioject’s Investor Relations Department.

 

Disclosures in securities filings and public communications should be complete, fair, accurate, timely and understandable. If you become aware of any information concerning (a) material defects in the disclosures made by Bioject in its public filings; (b) significant deficiencies in the design or operation of internal controls; (c) any violation of this Code that involves management or other employees who have a significant role in Bioject’s financial reporting, disclosures or internal controls; or (d) any material violation of the law or this Code, you should follow the guidelines described in Article VII.

 

ARTICLE VI
EMPLOYEE RELATIONS

 

Our goal is to make Bioject an exciting and dynamic place to work, where all employees are given the opportunity to achieve their potential.  A crucial factor in reaching this goal is ensuring that Bioject’s work environment is one that is safe and free of illegal discrimination or harassment of any kind.  You should become familiar with Bioject’s employment policies.

 

ARTICLE VII
COMPLIANCE PROCEDURES

 

If you have questions about this Code of Business Conduct and Ethics, or if you have concerns about conduct that you believe violates or may lead to a violation of this Code, it is important that you raise them through one of the channels described below.  Please be assured that Bioject does not allow retaliation against employees for good faith reports of misconduct.

 

                  You are always encouraged to bring questions or concerns to your supervisor.  Management can only make appropriate decisions if fully informed; it will be helpful if you present as complete a picture as possible to your supervisor.  It is the responsibility of every supervisor to assist in resolving these questions or concerns.

 

                  If you are more comfortable bringing your question or concern to a member of management who is not your supervisor, you are encouraged to contact any other member of management.

 

All employees are required to cooperate fully with any internal investigations of misconduct.

 

3



 

ARTICLE VIII
ADMINISTRATION AND ENFORCEMENT

 

The Board of Directors is responsible for the administration and enforcement of this Code of Business Conduct and Ethics, but may delegate its responsibility to a committee of the Board.  The Board shall take reasonable steps to monitor and audit compliance with the Code and to ensure that the Code continues to comply with all applicable rules and regulations.

 

Any waiver of this Code for an executive officer or director must be approved by the Board of Directors and will be promptly disclosed as required by law or regulation.  Any waiver for any other employee, representative, consultant or agent must be approved by the Board, the Chief Executive Officer, or the Chief Financial Officer.

 

This Code of Business Conduct and Ethics was adopted by the Board of Directors on March 11, 2004.  Amendments or changes to this Code may only be made by the Board.

 

4


EX-23 6 a04-1725_1ex23.htm EX-23

EXHIBIT 23

 

Independent Auditors’ Consent

 

The Board of Directors
Bioject Medical Technologies Inc.

 

We consent to the incorporation by reference in the registration statement Nos. 333-80679, 333-18933, 333-30955, 333-39421, 333-62889, 333-31542, 333-94907, 333-32848, 333-44556, 333-63568 and 333-81752 on Forms S-3 and registration statement Nos. 333-94400, 333-56454, 333-42156, 333-37017, 333-38206, 333-38212, 333-48632, 333-48634, 333-73868 and 333-108514 on Forms S-8 of Bioject Medical Technologies Inc. of our report dated January 30, 2004, with respect to the consolidated balance sheets of Bioject Medical Technologies Inc. and subsidiaries as of December 31, 2003 and 2002, and the related consolidated statements of operations, shareholders’ equity and cash flows for the year ended December 31, 2003, the nine month transition period ended December 31, 2002 and the year ended March 31, 2002, which report appears in the December 31, 2003 Annual Report on Form 10-K of Bioject Medical Technologies Inc.

 

 

/s/ KPMG LLP

 

Portland, Oregon

March 24, 2004

 


EX-31.1 7 a04-1725_1ex31d1.htm EX-31.1

EXHIBIT 31.1

 

 

CERTIFICATION PURSUANT TO
SECTION 302(a) OF THE SARBANES-OXLEY ACT OF 2002

 

I, James C. O’Shea, certify that:

 

1.               I have reviewed this annual report on Form 10-K of Bioject Medical Technologies Inc.;

 

2.               Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3.               Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4.               The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the registrant and have:

 

(a)          Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

(b)         Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(c)          Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5.               The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

(a)          All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

(b)         Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

 

Date: March 24, 2004

 

 

/s/ James C. O’Shea

 

James C. O’Shea

Chairman, Chief Executive Officer and President

Bioject Medical Technologies Inc.

 


EX-31.2 8 a04-1725_1ex31d2.htm EX-31.2

EXHIBIT 31.2

 

CERTIFICATION PURSUANT TO
SECTION 302(a) OF THE SARBANES-OXLEY ACT OF 2002

 

I, John Gandolfo, certify that:

 

1.               I have reviewed this annual report on Form 10-K of Bioject Medical Technologies Inc.;

 

2.               Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3.               Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4.               The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the registrant and have:

 

(a)          Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

(b)         Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(c)          Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5.               The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

(a)          All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

(b)         Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: March 24, 2004

 

 

/s/ John Gandolfo

 

John Gandolfo

Chief Financial Officer and Vice President of Finance

Bioject Medical Technologies Inc.

 


EX-32.1 9 a04-1725_1ex32d1.htm EX-32.1

EXHIBIT 32.1

 

CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

 

In connection with the Annual Report of Bioject Medical Technologies Inc. (the “Company”) on Form 10-K for the year ended December 31, 2003 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, James C. O’Shea, Chief Executive Officer of the Company, certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that, to the best of my knowledge,:

 

(1)       The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

 

(2)       The information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of the Company.

 

 

/s/ James C. O’Shea

 

James C. O’Shea

Chief Executive Officer

Bioject Medical Technologies Inc.

March 24, 2004

 

This certification is made solely for the purpose of 18 U.S.C. Section 1350, and not for any other purpose.  A signed original of this written statement required by Section 906 has been provided to Bioject Medical Technologies Inc. and will be retained by Bioject Medical Technologies Inc. and furnished to the Securities and Exchange Commission or its staff upon request.

 


EX-32.2 10 a04-1725_1ex32d2.htm EX-32.2

EXHIBIT 32.2

 

CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

 

In connection with the Annual Report of Bioject Medical Technologies Inc. (the “Company”) on Form 10-K for the period ended December 31, 2003 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, John Gandolfo, Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that, to the best of my knowledge,:

 

(1)          The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

 

(2)           The information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of the Company.

 

 

/s/ John Gandolfo

 

John Gandolfo

Chief Financial Officer

Bioject Medical Technologies Inc.

March 24, 2004

 

This certification is made solely for the purpose of 18 U.S.C. Section 1350, and not for any other purpose.  A signed original of this written statement required by Section 906 has been provided to Bioject Medical Technologies Inc. and will be retained by Bioject Medical Technologies Inc. and furnished to the Securities and Exchange Commission or its staff upon request.

 


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