-----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, HyKiqwejQafN5N1aYQ5oP/AiVmoaOcqHPwuToPVyVXAECt9wQMPsDOzCq6DJQbsV GX8SewnARyktGFYHtRqpIQ== 0000810084-97-000030.txt : 19970717 0000810084-97-000030.hdr.sgml : 19970717 ACCESSION NUMBER: 0000810084-97-000030 CONFORMED SUBMISSION TYPE: 10-K PUBLIC DOCUMENT COUNT: 6 CONFORMED PERIOD OF REPORT: 19970331 FILED AS OF DATE: 19970701 SROS: NASD FILER: COMPANY DATA: COMPANY CONFORMED NAME: BIOJECT MEDICAL TECHNOLOGIES INC CENTRAL INDEX KEY: 0000810084 STANDARD INDUSTRIAL CLASSIFICATION: 3841 IRS NUMBER: 931099680 STATE OF INCORPORATION: OR FISCAL YEAR END: 0331 FILING VALUES: FORM TYPE: 10-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-15360 FILM NUMBER: 97634808 BUSINESS ADDRESS: STREET 1: 7620 S W BRIDGEPORT RD CITY: PORTLAND STATE: OR ZIP: 97224 BUSINESS PHONE: 5036397221 FORMER COMPANY: FORMER CONFORMED NAME: BIOJECT MEDICAL SYSTEMS LTD DATE OF NAME CHANGE: 19920703 10-K405 1 ANNUAL REPORT SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ___________________________________ FORM 10-K (Mark one) [X] Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the fiscal year ended March 31, 1997 OR [ ] Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the transition period from __________ to ________ Commission File No. 0-15360 BIOJECT MEDICAL TECHNOLOGIES INC. (Exact name of registrant as specified in its charter) Oregon 93-1099680 (State of other jurisdiction of (I.R.S. identification no.) employer incorporation or organization) 7620 SW Bridgeport Road Portland, Oregon 97224 (Address of principal executive offices) (Zip code) (503) 639-7221 (Registrant's telephone number, including areas code) Securities registered pursuant to Section 12(b) of the Act: Title of each class Name of each exchange on which registered None None Securities registered pursuant to Section 12(g) of the Act: Title of Class Common Stock, no 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 [X] No [ ] 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 registrants 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. [ ] State the aggregate market value of voting stock held by non-affiliates of the registrant, as of May 31, 1997: $17,660,800 Indicate the number of shares outstanding of each of the registrant's classes of common stock, as of May 31, 1997: Common Stock, no par value, 19,540,413 shares. Documents Incorporated by Reference: Portions of the registrant's definitive Proxy Statement for the 1997 Annual Shareholders' Meeting are incorporated by reference into Part III 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 the 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 8. Consolidated Financial Statements and Supplementary Data Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 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 PART IV Item 14. Exhibits, Financial Statement Schedules and Reports on Form 8-K PART I ITEM 1. BUSINESS FORWARD-LOOKING STATEMENTS Certain statements in this Report constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such risks, uncertainties and factors include, among others, those described under "Business -- Risk Factors." GENERAL Bioject Medical Technologies Inc. ("Bioject" or the "Company") develops, manufactures and markets a jet injection system for needle-free drug delivery. Using this technology for injections virtually eliminates the associated risk of contaminated needlestick injuries and resulting blood- borne pathogen transmission, a major concern throughout the healthcare industry. The Company manufactures and markets a professional jet injection system, the Biojector (registered trademark) 2000, which allows healthcare professionals to inject medications through the skin, both intramuscularly in the deltoid muscle and subcutaneously, without a needle. The Biojector 2000 system consists of two components: a hand-held, reusable jet-injector (the "Biojector 2000"); and a sterile, single-use disposable syringe ("Biojector syringe"). The system is capable of delivering variable dose needle-free injections up to 1 ml. Additionally, the Company has developed a self-injection system for delivery of various medications up to 1 ml. for use by non-professionals, and the Company is also developing systems for Hoffmann-La Roche to use with certain of their products pursuant to an agreement signed January 10, 1995. See "Research and Product Development." Currently, medications are administered using various methods, each of which has advantages and limitations. The leading drug delivery techniques include oral ingestion, intravenous infusion, subcutaneous and intramuscular injection, inhalation and transdermal diffusion "patch." Many drugs are effective only when administered by injection. Studies indicate that there are more than four billion needle-syringes sold annually in the U.S. The Company believes that approximately 80% of these syringes are used for subcutaneous or intramuscular injections up to 1 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) patients' aversion to needles and discomfort. The most important 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 indicate that the total number of reported needlestick injuries in the U.S. exceeds 800,000 annually. In recent years, with the growing awareness of blood-borne pathogen transmission, safety has become a critical concern for hospitals and healthcare professionals as well as patients. As a result, pressures on the healthcare industry to eliminate the risk of contaminated needlestick injuries have 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 require the implementation of "engineering and work practice controls" to "isolate or remove the blood-borne pathogens hazard from the workplace." Among the required controls are special handling and disposal of contaminated "sharps" in biohazardous "sharps" containers and follow-up testing for victims of needlestick injuries. These regulations have significantly increased the cost of using needle-syringes. The costs resulting from needlestick injuries vary widely. Uncontaminated needlesticks involve relatively little cost, while investigating and following up contaminated needlestick injuries 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 over an extended period. Some healthcare providers are requiring additional measures, including presuming that all needlestick injuries involve contaminated needles unless proven otherwise and, under certain circumstances, administering prophylactic treatment such as zidovudine (AZT) or other drugs. The costs associated with treating needlestick injuries that result in infection by life-threatening pathogens, such as HIV or hepatitis B, are dramatically higher. In an effort to protect healthcare workers from needlestick injuries, many healthcare facilities have adopted more expensive, alternative technologies. One such technology is an intravenous ("IV") port that permits the injection of medication directly into the IV line without requiring the use of a sharp needle for each administration. Another is the "safety syringe," generally a disposable needle-syringe with a plastic sheath mechanism intended to cover the needle after use. Despite many efforts to reduce the risk of needlestick injuries, such injuries remain a major health concern. The Company's long-term goal is to establish its jet injection technology as the preferred drug delivery method for all medications administered by intramuscular or subcutaneous injection. The Company currently markets the Biojector 2000 system to public health and flu immunization clinics, and physician offices, has developed a self-injection device for the delivery of various medications to be delivered by non-professionals in the home and is developing application specific devices to be marketed by Hoffmann-La Roche. The Company is also seeking relationships with pharmaceutical and biotechnology companies to market its existing Biojector 2000 and self injector products for specific applications and to develop other application specific devices and companion syringes. THE COMPANY The Company's operations are conducted by Bioject Inc., an Oregon corporation, which is a wholly owned subsidiary of Bioject Medical Technologies Inc., an Oregon corporation (the "Company"). Although Bioject Inc. commenced operations in 1985, the Company was formed in December 1992 for the sole purpose of acquiring all the capital stock of Bioject Medical Systems Ltd., a Company organized under the laws of British Columbia, Canada, in a stock-for-stock exchange in order to establish a U.S. domestic corporation as the publicly traded parent company for Bioject Inc. and Bioject Medical Systems Ltd. Bioject Medical Systems Ltd. was terminated in fiscal 1997. All references to the Company herein are to Bioject Medical Technologies Inc. and its subsidiary, unless the context requires otherwise. The Company's executive offices and operations are located at 7620 SW Bridgeport Road, Portland, Oregon 97224, and its telephone number is (503) 639-7221. "Biojector" and "Bioject" are trademarks of the Company. DESCRIPTION OF THE COMPANY'S PRODUCTS The Company's current product, the Biojector 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. Giving an injection with a Biojector 2000 system is easy and straightforward. The healthcare worker checks the CO2 pressure on the easy-to-read gauge at the rear of the injector, draws up medication into the plastic syringe discarding the fill needle in a sharps container, inserts the syringe into the power injector, presses the syringe tip against the appropriate disinfected surface on the patient's skin, and then presses an actuator thereby injecting the medication. Medication is expelled rapidly through a precision molded, small diameter orifice in a thin stream at a velocity sufficient to penetrate the skin and force the medication into the tissue at the desired level. The Biojector 2000 system 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 ml. The first component, the Biojector 2000, is a portable hand-held unit (about the size of a flashlight) which is designed to be easy to use by healthcare professionals, as well as attractive and non-threatening to patients. As described in the June 7, 1993 issue of BUSINESSWEEK, the Biojector 2000 won the 1993 Gold Industrial Design Excellence Award given by Industrial Designers Society of America for its aesthetically pleasing and ergonomic design. In July 1994, the Biojector 2000 also received the Alliance of Children's Hospitals Seal of Approval. The Biojector 2000 injector uses disposable CO2 cartridges as a power source. The CO2 cartridges, which are purchased by the Company from an outside supplier, give an average of ten injections before requiring replacement. The CO2 gas provides consistent, reliable pressure in order to push the syringe plunger and thereby propel the medication. The CO2 does not come into contact with the patient or medication. The second component, the Biojector single-use disposable syringe, is provided in a sterile, peel-open package and consists of a plastic, needle- free, variable dose syringe containing a plunger, accompanied by a needle used only for filling. The body of the syringe is transparent and has graduated markings to aid filling by healthcare workers in the same way as traditional needle-syringes are filled. However, unlike the traditional needle-syringe, the Biojector fill needle is designed to be immediately discarded in a "sharps" container as soon as the syringe is filled, so that a needle need never come near a patient when an injection is being given. More importantly, since no needle penetrates the patient's skin, the risk of contaminated needlestick injury is virtually eliminated. Under OSHA regulations, used Biojector syringes need not be disposed of in a special biohazardous "sharps" container. There are five different Biojector syringes, each of which is intended for a different injection depth or body type. The syringes are molded using the Company's patented manufacturing process. The 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. The current suggested retail list price for the Biojector 2000 professional jet injector is $995, and the suggested retail list price for syringes is $1.00 a piece. CO2 cartridges are sold for a suggested retail price of $0.50 per cartridge and average ten injections per cartridge. Discounts are offered for volume purchases. The Company has other products in development which are intended to address other markets or to enhance the Biojector 2000 system. See "Research and Product Development." INDUSTRY BACKGROUND In 1836, LaForgue developed the concept of placing medicine under the skin by means of a needle lance trochar. In 1853, Wood developed the hollow-needle hypodermic which was later improved by Hunter, Pravaz and many others. The basic needle-syringe in use across the healthcare market today is a direct derivation from the original Wood design and involves a hollow steel needle of various diameters and lengths attached to a plastic syringe body and plunger. The entire unit requires special handling and disposal. The next fundamental improvement in injection technique for parenteral administration was made approximately 100 years following Wood's development of the hollow-needle hypodermic. This improvement was the development of a pneumatically powered hypodermic device which was capable of injecting medication through the skin without a needle. These early needle-free injection devices were large and bulky devices which lent themselves to mass inoculations but were inappropriate for single-shot administrations of medication in the physician's office, hospital or in the home setting. During the last 20 years, there have been many attempts to develop portable one-shot needle-free hypodermic devices. Some of the problems which arose in these attempts to develop such devices include: (a) inadequate injection power; (b) little or no control of pressure and depth of penetration; (c) complexity of design with related difficulties in cost and performance; (d) difficulties in use, including filling and cleaning; and (e) the necessity for sterilization between patients. In recent years, several spring-driven needle-free injectors have been developed and marketed primarily for the injection of insulin. Each of these devices requires regular cleaning as well as filling from a separate medication bottle or vial. Current prices for such injectors range from approximately $400 to $600 per injector. The Company believes that due to the cost combined with the difficulties of use, market acceptance of these devices has been limited. Also in recent years, various versions of a "safety syringe" have been designed and marketed. These syringes generally involve as their basic design a standard or modified needle-syringe with a plastic guard or sheathing surrounding the needle. Such covering is usually retracted or removed in order to give the injection. Although the intent of the safety syringes is to reduce or eliminate needlestick injuries, the syringes require manipulation after injection and, therefore, still pose the risk of needlestick injury. They are also bulky and add to contaminated waste disposal problems. MARKETING AND COMPETITION The Company is currently focusing on gaining acceptance of the Biojector system in the U.S. public health clinic and flu immunization markets. The Company is also working on arrangements to market the Biojector 2000 system to the U.S. physician office market and the home healthcare market. The Company plans eventually to expand into international markets. Different marketing and distribution approaches are required in each of these markets. As new products are developed, the Company intends to establish additional channels of distribution. For example, the Company is developing an injection system for specific applications which is anticipated to be marketed by Hoffmann-La Roche. Pre-filled Biojector syringes, if developed, would be filled and marketed by the pharmaceutical or biotechnology companies involved. The Company currently employs five sales representatives to be a dedicated sales force to sell the Company's Biojector 2000 system directly to the public health clinic and flu immunization markets in key metropolitan areas. These sales representatives are led by a vice president of sales and marketing and are supported by a product manager, customer service staff, three full time nurse trainers and 10-20 per diem nurse trainers. Bioject's direct sales efforts have resulted in the signing of public health agreements for the state of North Carolina, the New York City Middle Schools, and the health departments in the states of New Mexico and Oklahoma. The Company expects to sign additional agreements with other public health agencies. The Company has a national agreement with the Visiting Nurses Associations for use of the Biojector 2000 system for flu immunization. In addition, through the VNA member organizations, it was recently announced that the Company will participate in a new flu immunization program to be sponsored by Wal-Mart this fall. It is the Company's intention to leverage its success in these immunization programs to attract pharmaceutical company strategic partners to assist it in gaining access to the physician office and other specialized markets where the benefits of needle-free drug delivery will enhance the distribution of their injectible medications. In August 1994, Bioject signed an agreement with Homecare Management, Inc. (HMI), granting HMI exclusive rights to purchase Bioject's Needle-Free Injection Management System, the Biojector 2000, for use in the home healthcare market. Sales to HMI commenced in August 1994. In return for HMI's commitment to purchase a minimum of 8,000 Biojector units over the ensuing two years, the Company granted volume pricing discounts to HMI. Throughout the term of the contract the selling price of Biojectors to HMI exceeded their standard cost. During fiscal 1995 and 1996, the Company sold approximately 2,100 and 4,300 Biojectors to HMI for total sales revenue including syringes of $1.1 million and $2.2 million, respectively. HMI had not placed the great majority of these Biojectors with patients pending completion of negotiations with pharmaceutical companies for certain pricing concessions for medication to be administered with the Biojectors. In January 1996, HMI requested that further shipments under the contract be suspended. In February 1996, the Company learned from HMI's press releases that HMI expected to default under its loan, to take significant write-offs for accounts receivable and inventories, planned operational consolidations, and would restate certain prior period financial statements. In fiscal 1997, the Company agreed to repurchase certain of the Biojector inventories (including up to 6,000 devices) which HMI had on hand for a total of $660,000 including $322,000 of forgiveness of accounts receivable and payment of $338,000 in two installments, one-half of which was paid in July 1996 and with the balance remaining outstanding. The Company was under no obligation to repurchase these inventories, and the repurchase was at a substantial discount to the original selling price to HMI. The sale of new technologies to hospitals and large clinics can be a lengthy process. Introduction of new technologies to a hospital or large clinic typically involves screening by many individuals and committees within the institution, including new product evaluation committees, infection control officers, medical staff and business office personnel. Therefore, in order to shorten the sales cycle, the Company has adopted a strategy that focuses instead on the public health and flu immunization markets where there are fewer and more concentrated decision makers. The medical equipment market is highly competitive, and competition is likely to intensify. Many of the Company's existing and potential competitors have been in business longer than the Company and have substantially greater technical, financial, marketing, sales and customer support resources. The Company believes the primary competition for the Biojector 2000 system and other jet injectors it 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 $0.10 to $0.20 per unit. Manufacturers of "safety syringes" compete on features, quality and price. "Safety syringes" generally are priced in a range of $0.25 to $0.45 per unit. The Company expects to compete with traditional needle-syringes and "safety syringes" based on healthcare worker safety, ease of use, reduced cost of disposal, patient comfort, and compliance with OSHA regulations, but not on purchase price. However, the Company believes that when all indirect costs (including disposal of syringes and testing, treatment and workers' compensation expense related to needlestick injuries) are considered, the Biojector 2000 system will compete effectively. See "Forward Looking Statements" and "Risk Factors." The Company is not aware of any competing products with features and benefits comparable to the Biojector 2000 system. The Company is aware of other portable needle-free injectors on the market today but these are generally focused on subcutaneous self-injection applications of 0.5 ml. or less whereas the Company's products are suitable for both intramuscular and subcutaneous 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 the Company's products. There can be no assurance that the Company will be able to compete successfully in this market. See "Risk Factors - Competition," "- Dependence on Single Technology." A variety of new technologies (for example, transdermal patches) are being developed as alternatives to injection for drug delivery. While the Company does 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. PATENTS AND PROPRIETARY RIGHTS The Company believes that technology incorporated in its injection device, single-dose disposable plastic syringes and products under development gives it significant advantages over the manufacturers of other jet injection systems and over prospective competitors seeking to develop similar systems. The Company attempts to protect its technology through a combination of trade secrets, confidentiality agreements and procedures and patent prosecution. The Company has three U.S. patents which were issued with respect to jet injection technology incorporated in earlier versions of its jet injection systems and which expire from July 2007 to November 2008. Seven additional U.S. patents have been issued which protect developments incorporated in the Biojector 2000 system. These patents incorporate a number of claims including claims regarding the jet injection system's design, method of operation, certain aspects of the syringe design and the method of manufacturing the syringe orifice. The Company has also been granted patents relating to an electronic self-injection device and a drug mixing vial, newer technologies not yet incorporated in any product. The Company has made additional patent filings regarding pre-filled syringe technologies and adapters for drug vial access. The Company also generally files patent applications in Canada, Europe and Japan at the times and under the circumstances it deems filing to be appropriate under the procedures in place in each jurisdiction. There can be no assurance that any patents applied for will be granted or that patents held by the Company will be valid or sufficiently broad to protect the Company's technology or provide a significant competitive advantage. See "Risk Factors." The Company also relies on trade secrets and proprietary know-how that it seeks to protect through confidentiality agreements with its employees, consultants, suppliers and others. There can be no assurance that these agreements will not be breached, that the Company would have adequate remedies for any breach, or that the Company's trade secrets will not otherwise become known to or be developed independently by competitors. In addition, the laws of foreign countries may not protect the Company's proprietary rights to its technology, including patent rights, to the same extent as the laws of the U.S. Although the Company believes that it has independently developed its technology and attempts to assure that its products do not infringe the proprietary rights of others, if infringement were alleged and proved, there can be no assurance that the Company could obtain necessary licenses on terms and conditions that would not have an adverse affect on the Company. The Company is not aware of any asserted claim that the Biojector 2000 or any product under development violates the proprietary rights of any person. If a dispute arises concerning the Company's technology, litigation that could result in substantial cost to and diversion of effort by the Company might be necessary to enforce the Company's patents, to protect the Company's trade secrets or know-how or to determine the scope of the proprietary rights of others. Adverse findings in any proceeding could subject the Company to significant liabilities to third parties, require the Company to seek licenses from third parties or otherwise adversely affect the Company's ability to manufacture and sell its products. GOVERNMENTAL REGULATION The Company's products and manufacturing operations are subject to extensive government regulations, both in the U.S. and abroad. In the U.S., the Food and Drug Administration ("FDA") administers the Federal Food, Drug and Cosmetic Act (the "FFDCA") and has adopted regulations, including those governing the introduction of new medical devices, the observation of certain standards and practices with respect to the manufacturing and labeling of medical devices, the maintenance of certain records and the reporting of device-related deaths, serious injuries, and certain malfunctions to the FDA. Manufacturing facilities and certain Company records are also subject to FDA inspections. The FDA has broad discretion in enforcing the FFDCA and the regulations thereunder, and noncompliance can result in a variety of regulatory steps ranging from warning letters, product detentions, device alerts or field corrections to mandatory recalls, seizures, injunctive actions and civil or criminal penalties. The FFDCA provides that, unless exempted by regulation, medical devices may not be commercially distributed in the U.S. unless they have been cleared or approved by the FDA. The FFDCA provides two basic review procedures for pre-market clearance or approval of medical devices. Certain products qualify for a submission authorized by Section 510(k) of the FFDCA, wherein the manufacturer provides the FDA with a premarket notification ("510(k) notification") of the manufacturer's intention to commence marketing the product. The manufacturer must, among other things, establish in the 510(k) notification that the product to be marketed is substantially equivalent to another legally marketed product, (i.e., that it has the same intended use and that it as safe and effective as a legally marketed device and does not raise questions of safety and effectiveness that are different from those associated with the legally marketed device). Marketing may commence when the FDA issues a letter 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 test results. If a medical device does not qualify for the 510(k) procedure, the manufacturer must file a premarket approval ("PMA") application. A PMA must show that the device is safe and effective and is generally a much more complex submission than a 510(k) notification typically requiring more extensive prefilling testing 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. A 510(k) notification is also required when the manufacturer makes a change or modification to an already marketed device that could significantly affect safety or effectiveness, or where 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 necessitate the filing of a new 510(k) notification. The FDA's regulations provide only limited guidance in making this determination. In April 1987, the Company received 510(k) marketing clearance from the FDA allowing the Company to market a hand-held CO2-powered jet injection system. Although the Biojector 2000 system incorporates changes from the system with respect to which the Company's 1987 510(k) marketing clearance was received and expands its intended use, the Company made the determination that these were not major changes or modifications in intended use or changes in the device that could significantly affect the safety or effectiveness of the device and that, accordingly, the 1987 510(k) clearance permitted the Company to market the Biojector 2000 system in the U.S. In June 1994, the Company received clearance from the FDA under 510(k) to market a version of its Biojector 2000 system in a configuration targeted at high volume injection applications. In October 1996, the Company received 510(k) clearance for a non-needle disposable vial access device. In March 1997, the Company received additional 510(k) clearance for certain enhancements to its Biojector 2000 system. The Company expects that the self-injection and other systems under development would require new 510(k) submissions. See "Research and Product Development" and "Forward Looking Statements". However, there can be no assurance that the FDA will concur with the Company's determination that the product can be cleared via a 510(k) submission. The Company continues to seek arrangements with pharmaceutical companies to develop pre-filled Biojector syringe applications to permit the pharmaceutical companies to market their products packaged in Biojector prefilled containers. See "Research and Product Development." Before pre-filled Biojector syringes may be distributed for use in the U.S., certain FDA- mandated stability tests may be required of those pharmaceutical companies. Pre-filled syringes involve drugs packaged as a component of a medical device. It is current FDA policy that such pre-filled syringes, which are considered to be combination products, are evaluated by the FDA as drugs rather than medical devices. Marketing of pre-filled syringes by pharmaceutical companies will require prior approval via a New or amended Drug Application ("NDA") or an Abbreviated New Drug Application ("ANDA"). An NDA is a complex submission required to establish that a drug will be safe and effective for its intended uses. An ANDA is a less detailed process which does not require, among other things, that the applicant provide complete reports of preclinical and clinical studies of safety and efficacy as are required for NDAs. Assuming that the drugs used in the pre- filled syringes have previously been approved by the FDA for injection, the FDA will likely require that ANDAs, rather than NDAs, be submitted. The Company believes that if a drug to be used in the Company's pre-filled syringe were already the subject of an approved NDA or ANDA for intramuscular or subcutaneous injection, the main issue affecting approval for use in the pre-filled syringe would be the adequacy of the syringe to store the drug, to assure its stability until used and to safely deliver the proper dose. See "Forward Looking Statements" and "Risk Factors - Government Regulation." The FDA also regulates the Company's quality control and manufacturing procedures by requiring the Company and its contract manufacturers to demonstrate compliance with current Good Manufacturing Practice ("GMP") Regulations. These regulations require, among other things, that (i) the manufacturing process must be regulated and controlled by the use of written procedures and (ii) the ability to produce devices which meet the manufacturer's specifications must be validated by extensive and detailed testing of every aspect of the process. They also require investigation of any deficiencies in the manufacturing process or in the products produced and detailed record-keeping. Further, the FDA's interpretation and enforcement of these requirements has been increasingly strict in recent years and seems likely to be even more stringent in the future. Failure to adhere to GMP requirements would cause the products produced to be considered in violation of the Act and subject to enforcement action. The FDA monitors compliance with these requirements by requiring manufacturers to register with the FDA, and subjecting them to periodic FDA inspections of manufacturing facilities. If the inspector observes conditions that might be violated, the manufacturer must correct those conditions or explain them satisfactorily, or face potential regulatory action that might include physical removal of the product from the marketplace. The FDA's Medical Device Reporting Regulation requires that the Company provide information to the FDA on the occurrence of any death or serious injuries alleged to have been associated with the use of the Company's products, as well as any product malfunction that would likely cause or contribute to a death or serious injury if the malfunction were to recur. In addition, FDA regulations prohibit a device from being marketed for unapproved or uncleared indications. If the FDA believes that the company is not in compliance with these regulations, it can institute proceedings to detain or seize products, issue a recall, seek injunctive relief or assess civil and criminal penalties against such company. The use and manufacture of the Company's products are subject to OSHA and other federal, state and local laws and regulations relating to such matters as safe working conditions for healthcare workers and Company employees, manufacturing practices, environmental protection and disposal of hazardous or potentially hazardous substances and the policies of hospitals and clinics relating to compliance therewith. There can be no assurance that the Company will not be required to incur significant costs to comply with such 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 the Company's products or otherwise have a materially adverse effect upon the Company's ability to do business. See "Risk Factors." Laws and regulations regarding the manufacture, sale and use of medical devices are subject to change and depend heavily on administrative interpretations. There can be no assurance that future changes in regulations or interpretations made by the FDA, OSHA or other regulatory bodies, will not adversely affect the Company. Sales of medical devices outside of the United States are subject to foreign regulatory requirements. The requirements for obtaining premarket clearance or approval by a foreign country may differ from those required for FDA clearance or approval. 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. RESEARCH AND PRODUCT DEVELOPMENT Research and development efforts are focused on enhancing the Company's current product offerings and developing both new jet injection technology and new products. The Company continues to use clinical, magnetic resonance imaging and tissue studies to determine the reliability and performance of new and existing products. As of March 31, 1997, the Company's research and product development staff consisted of 5 employees. During fiscal 1995, 1996 and 1997, the Company spent $1.4 million, $1.5 million, and $1.3 million, respectively, on research and development. In March 1994, the Company entered into an agreement with Schering AG, Germany, for the development of a self-injection device for delivery of Betaseron to multiple sclerosis patients. During fiscal 1995 through 1997, the Company developed prototypes to Schering specifications which were accepted by Schering. During fiscal 1997, the Company entered into a supply agreement with Schering AG and commenced activities related to full production of the self injector. Schering loaned the Company a total of $1.6 million to purchase molds and tooling for production of the product. In January 1997, the Company received notice that its contract with Schering AG would be cancelled. Under provisions of the contract, Schering AG had the option of canceling the agreement if the FDA required extensive clinical studies beyond an originally planned safety study. Schering AG received a review letter from the FDA which would have required Schering to conduct additional material clinical studies in order to use non- traditional delivery mechanisms with its Betaseron (r) product. Under terms of the contract, Schering was required to convert its $1.6 million note due from Bioject into approximately 460,000 shares of Bioject common stock at a conversion price of $3.50 per share. In addition, $106,000 of accrued interest was converted into approximately 27,000 shares of Bioject common stock at a conversion price of $3.50 per share. Schering is obligated to pay Bioject for the cost of product ordered through the date of cancellation of the contract. Under terms of the agreement, in April 1994, Schering paid a one-time $500,000 licensing fee for access to the Company's technology and paid $600,000 as its contribution toward Phase I of the development. In October 1995 Schering paid $600,000 as its contribution toward Phase II development and $60,000 of additional costs associated with completion of Phase I. During fiscal 1997, Schering paid $300,000 for Phase III development costs. In January 1995, the Company signed a joint development agreement with Hoffmann-La Roche to develop proprietary drug delivery systems for Roche products. The agreement provides for Bioject to develop, manufacture and sell Biojector needle-free drug delivery systems designed to Roche specifications. In return, Bioject has granted Roche exclusive worldwide rights to distribute these systems and their components for use with certain Roche products. Hoffmann-La Roche Inc. is the United States affiliate of the multinational group of companies headed by Roche Holding of Basel, Switzerland, one of the world's leading research-intensive healthcare companies. As of 1995 fiscal year end, the Company had commenced design of a prototype device and had agreed with Roche on product specifications. During fiscal 1996, the Company developed and delivered to Roche preproduction prototypes for testing and developed the clinical preproduction prototypes which were delivered to Roche in April 1996. As of March 31, 1997, the Company and Hoffmann-LaRoche were finalizing their submission to obtain regulatory approval to market the product. Hoffmann-LaRoche was also gathering marketing information in order to sign a supply agreement. In February 1995, Hoffmann-La Roche paid a one-time licensing fee totalling $500,000, and the agreement provides that it will pay specified product development fees on an agreed upon schedule of which $900,000 was paid in fiscal 1996 and $250,000 was paid in fiscal 1997. In addition to activities described above, the Company is seeking arrangements with pharmaceutical and biotechnology companies for the use of pre-filled syringes to eliminate the filling and measuring procedures associated with traditional injection of medications. Before pre-filled Biojector syringes may be distributed for use in the U.S., these companies must commit to the packaging and distribution of their products in this manner and to the time and financial resources necessary for FDA review and approval. This process could be lengthy. See "Business -- Government Regulation." There can be no assurance that such companies will commit efforts to develop pre-filled packaging and pursue regulatory approval or that regulatory approval of pre-filled Biojector syringes will be obtained. The Company intends to continue research and development efforts designed to further its understanding of the physics and physiology of jet injection. These efforts will include further clinical studies to demonstrate efficacy of jet injection and to evaluate new products and enhancements to the Company's existing products. To advance these studies, in April 1994 the Company formed a Department of Clinical Affairs research group, which initiates and coordinates these studies. MANUFACTURING The Company assembles the Biojector 2000 and related syringes from components purchased from outside suppliers. Prior to introduction of the Biojector 2000 system in 1993, the Company had not engaged in manufacturing on a commercial scale. However, in connection with that introduction, the Company increased its manufacturing capabilities and built inventories to support anticipated product sales. Throughout fiscal 1994 and 1995, the Company's manufacturing processes were primarily manual. These processes did not permit the Company to produce its products at costs which would allow it to operate profitably. During fiscal 1996, the Company implemented a plan to increase manufacturing capacity and refine production methods to meet anticipated future demand and to reduce product costs. For the Biojector 2000, cost reduction efforts included converting from a two piece to a one piece housing, converting to continuous process manufacturing and implementing volume purchasing programs from suppliers. For the Biojector syringes, these efforts included increasing supplier mold capacity and automating final assembly and packaging. See "Risk Factors - Limited Manufacturing Experience, Need to Reduce Unit Cost." During fiscal 1997, the Company's manufacturing activities focused on retesting the devices repurchased from HMI to ensure their continuing compliance with new product standards and selective upgrade of certain of these units to current version configuration. Manufacturing also focused on finalizing product engineering and bringing up the new self injector device and syringe manufacturing lines in advance of product launch. In order to succeed in expanding manufacturing capacity and reducing unit production cost, the Company must attract and retain qualified assembly workers and must establish and maintain relationships with suppliers that can deliver large numbers of components meeting applicable quality standards in a timely and reliable manner at acceptable prices. EMPLOYEES As of March 31, 1997, the Company had 39 full-time employees with 5 employees engaged in research and product development, 10 in sales and marketing, 15 in manufacturing and 9 in administration. The Company engages a limited number of part-time consultants who participate in research activities. The Company also employs temporary contract workers primarily for assembly operations, the number of which varies, depending upon production requirements. As of March 31, 1997, there was one consultant, 8 to 12 per diem nurses and one contract/temporary worker employed by the Company. None of the Company's employees is represented by a labor union. PRODUCT LIABILITY The Company believes that its products reliably inject medications both subcutaneously and intramuscularly when used in accordance with product guidelines. The Company's current insurance policies provide coverage at least equal to an aggregate limit of $6 million with respect to certain product liability claims. The Company has not experienced any product liability claims to date. There can be no assurance, however, that the Company will not become subject to such claims, that the Company's current insurance would cover such claims, or that insurance will continue to be available to the Company in the future. The Company's business may be adversely affected by product liability claims. RISK FACTORS Investment in securities of the Company involves a high degree of risk. The following factors, among others, should be considered by investors. NEED FOR ADDITIONAL FINANCING. The Company believes that its current cash position and cash received from a private placement of common stock and warrants in June 1997, combined with revenues and other cash receipts will not be adequate to fund the Company's operations through the end of fiscal 1998. The Company has identified a number of potential financing sources and is pursuing them aggressively. See "Forward Looking Statements". Even if the Company is successful in raising additional financing, unforeseen costs and expenses or lower than anticipated cash receipts from product sales or research and development activities could accelerate or increase the financing requirements. The Company has been successful in raising additional financing in the past and believes that sufficient funds will be available to fund future operations. See "Forward Looking Statements." However, there can be no assurance that the Company's efforts will be successful, and there can be no assurance that such financing will be available on terms which are not significantly dilutive to existing shareholders. Failure to obtain needed additional capital on terms acceptable to the Company, or at all, would significantly restrict the Company's operations and ability to continue product development and growth and materially adversely affect the Company's business. The Company has no banking line of credit or other established source of borrowing. The Company's independent accountants have qualified their opinion with respect to their audit of the Company's 1997 consolidated financial statements as the result of doubts concerning the Company's ability to continueas a going concern in the absence of additional financing. UNCERTAINTY OF MARKET ACCEPTANCE. The Company's success will depend upon market acceptance of its jet injection drug delivery system, the Biojector 2000 system, and, to other products under development. Currently, the dominant technology used for intramuscular and subcutaneous injections is the hollow-needle syringe. Needle-syringes, while low in cost, have limitations, particularly relating to contaminated needlestick injuries. Use of the Biojector 2000 system for intramuscular and subcutaneous injections virtually eliminates the associated risk of these injuries; however, the cost per injection is significantly higher. As with any new technology, there can be no assurance that the Biojector 2000 system will compete successfully. A previous jet injection system manufactured by the Company did not achieve market acceptance and is no longer being marketed. The Biojector 2000 was introduced in January 1993. To date the major portion of sales have been sales to HMI that were not placed in service and which the Company agreed to repurchase at a substantial discount to the original selling price. Failure of the Biojector 2000 system to gain market acceptance would have a material adverse effect on the Company's financial condition and results of operations. HISTORY OF LOSSES; UNCERTAIN PROFITABILITY. Since its formation in 1985, the Company has incurred significant annual operating losses and negative cash flow. At March 31, 1997 the Company had an accumulated deficit of $34.2 million. The Company's revenues to date have been derived primarily from licensing and technology fees, and from product sales, which were principally sales to dealers for the stocking of inventories and to HMI. There can be no assurance that the Company will be able to generate significant revenues or achieve profitability. See "Management's Discussion and Analysis of Financial Condition and Results of Operations." LIMITED MANUFACTURING EXPERIENCE; NEED TO REDUCE UNIT COST. The Company has limited experience manufacturing its products in commercial quantities. The Company has increased its production capacity for the Biojector 2000 system through automation of, and changes in, production methods. The current cost per injection of the Biojector 2000 system is substantially higher than that of traditional needle-syringes, its principal competition. A key element of the Company's business strategy is to reduce the overall system cost through automating production and packaging. The Company has experienced and may continue to experience setbacks and delays in its cost reduction efforts including failure to deliver reduced cost parts to specifications. There can be no assurance that the Company will be able to develop and implement effective high volume production or achieve necessary unit cost reductions. Failure to do either would adversely affect the Company's financial condition and results of operations. See "Management's Discussion and Analysis of Financial Condition and Results of Operation" and "Manufacturing." GOVERNMENTAL REGULATION. The Company's products and manufacturing operations are subject to extensive government regulation, both in the U.S. and abroad. In the U.S., the development, manufacture, marketing and promotion of medical devices are regulated by the Food and Drug Administration ("FDA") under the Federal Food, Drug, and Cosmetic Act ("FFDCA"). In 1987, the Company received clearance from the FDA under Section 510(k) of the FFDCA to market a hand-held CO2-powered jet injection system. The FFDCA provides that new premarket notifications under Section 510(k) of the FFDCA are required to be filed when, among other things, there is a major change or modification in the intended use of a device or a change or modification to a legally marketed device that could significantly affect its safety or effectiveness. Although the Biojector 2000 system incorporates changes from the system with respect to which the Company's 1987 510(k) marketing clearance was received and expands its intended use, the Company made the determination that these were not major changes or modifications in intended use or changes in the device that could significantly affect the safety or effectiveness of the device and that, accordingly, the 1987 510(k) clearance permitted the Company to market the Biojector 2000 system in the U.S. In June 1994, the Company received clearance from the FDA under 510(k) to market a version of its Biojector 2000 system in a configuration targeted at high volume injection applications. In October 1996, the Company received 510(k) clearance for a non-needle disposable vial access device. In March 1997, the Company received FDA 510(k) clearance to market the Biojector 2000 incorporating certain enhancements to the product. Future changes to manufacturing procedures could necessitate the filing of a new 510(k) notification. Also, future products, product enhancements or changes, or changes in product use may require clearance under Section 510(k), or they may require FDA premarket approval ("PMA") or other regulatory approvals. PMAs and these other regulatory approvals generally involve more extensive prefilling testing that a 510(k) clearance and a longer FDA review process. Under current FDA policy, applications involving prefilled syringes would he evaluated by the FDA as drugs rather than devices, requiring NDAs or ANDAs. See "Governmental Regulation." Depending on the circumstances, drug regulation can be more bureaucratic and time consuming than device regulation. FDA regulatory processes are time consuming and expensive, and there can be no assurance that product applications submitted by the Company will be cleared or approved by the FDA. In addition, the Company's products must be manufactured in compliance with Good Manufacturing Practices ("GMP") specified in regulations under the FDA Act. The FDA has broad discretion in enforcing the FDA Act, and noncompliance with the Act could result in a variety of regulatory actions ranging product detentions, device alerts or field corrections, to mandatory recalls, seizures, injunctive actions, and civil or criminal penalties. Distribution of the Company's products in countries other than the U.S. may be subject to regulation in those countries. An application was made to the Japan Ministry of Health and Welfare to obtain necessary approvals to market the Biojector 2000 system in Japan which was not carried to completion by the Company's then Japanese distributor. See "Governmental Regulation." UNCERTAINTY IN HEALTHCARE INDUSTRY; GOVERNMENT HEALTHCARE REFORM. 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 healthcare costs by limiting both coverage and reimbursement levels for healthcare products and procedures. Because the price of the Biojector 2000 system exceeds the price of needle injection systems, cost control policies of third party payers, including government agencies, may adversely affect use of the Biojector 2000 system. DEPENDENCE ON THIRD-PARTY RELATIONSHIPS. The Company is dependent on third parties for distribution of the Biojector 2000 system to certain market segments, for the manufacture of component parts, and for assistance with the development and distribution of its future Betaseron self-injection and application specific systems. The Company intends to seek relationships to distribute to the physician office market in the future. Past dealer relationships have not been successful. There can be no assurance that the Company's future dealers will provide sufficient sales support to establish the Company's current product. See "Marketing and Competition." The Company's current manufacturing processes for the Biojector 2000 jet injector and disposable syringes consist primarily of assembly of component parts supplied by outside suppliers. Certain of these components are currently obtained from single sources, with some components requiring significant production lead times. In the past, the Company has experienced delays in the delivery of certain components, although to date no such delays have had a material adverse effect on the Company's operations. There can be no assurance that the Company will not experience delays in the future, or that such delays would not have a material adverse effect on the Company's financial condition and result of operations. See "Manufacturing." The Company has entered into agreements with certain major pharmaceutical companies for development and distribution of its jet injection systems. These companies have the right to terminate these agreements at certain phases as defined in the agreements. There can be no assurance these companies interest and participation in the projects will continue. Failure to receive additional funding from these companies could adversely affect the development and production of the products involved and, correspondingly, the Company's financial condition and results of operations. See "Research and Product Development." ABILITY TO MANAGE GROWTH. If the Company's products achieve market acceptance, the Company expects to achieve rapid growth. This growth strategy will require expanded customer services and support, increased personnel throughout the Company, expanded operational and financial systems, and the implementation of new control procedures. There can be no assurance that the Company will be able to attract qualified personnel or successfully manage expanded operations. As the Company expands, it may from time to time experience constraints that would adversely affect its ability to satisfy customer demand in a timely fashion. Failure to manage growth effectively could adversely affect the Company's financial condition and results of operations. COMPETITION. The medical equipment market is highly competitive and competition is likely to intensify. The Company's products compete primarily with traditional needle-syringes, "safety syringes" and also with other alternative drug delivery systems. In recent years, some needle-free self injectors have also gained some market prominence including signing of certain corporate partnerships. While the Company believes its products provide a superior drug delivery method, there can be no assurance that the Company will be able to compete successfully with existing drug delivery products. Many of the Company's competitors have longer operating histories as well as substantially greater financial, technical, marketing and customer support resources than the Company. There can be no assurance that one or more of these competitors will not develop an alternative drug delivery system that competes more directly with the Company's products, or that the Company's products would be able to compete successfully with such a product. See "Marketing and Competition." DEPENDENCE ON SINGLE TECHNOLOGY. The Company's strategy has been to focus its development and marketing efforts on its jet injection technology. This focus renders the Company particularly sensitive to competing products and alternative drug delivery systems. The Company believes that healthcare providers' desire to minimize the use of the traditional needle-syringe has stimulated development of a variety of alternative drug delivery system such as "safety syringes," jet injection systems and transdermal diffusion "patches." In addition, pharmaceutical companies frequently attempt to develop drugs for oral delivery instead of injection. While the Company believes that for the foreseeable future there will continue to be a significant need for injections, there can be no assurance that alternative drug delivery methods will not be developed which are preferable to injection. See "Marketing and Competition." PATENTS AND PROPRIETARY RIGHTS. The Company relies on a combination of trade secrets, confidentiality agreements and procedures, and patent prosecution to protect its proprietary technologies. The Company has been granted seven patents in the United States and two patents in certain other countries covering certain technology embodied in its current jet injection system and certain manufacturing processes. Additional patent applications are pending in the U.S and certain foreign countries. There can be no assurance that the claims contained in any patent application will be allowed, or that any patent will provide adequate protection for the Company's products and technology. In the absence of patent protection, the Company may be vulnerable to competitors who attempt to copy the Company's products or gain access to its trade secrets and know-how. In addition, the laws of foreign countries may not protect the Company's proprietary rights to this technology to the same extent as the laws of the U.S. The Company believes that it has independently developed its technology and attempts to ensure that its products do not infringe the proprietary rights of others, and the Company knows of no infringement claims. However, any such claims could have a material adverse affect on the Company's financial condition and results of operations. See "Patents and Proprietary Rights." PRODUCT LIABILITY. Producers of medical devices may face substantial liability for damages in the event of product failure or if it is alleged the product caused harm. The Company currently maintains product liability insurance and has not experienced any product liability claims to date. There can be no assurance, however, that the Company will not be subject to such claims, that the Company's current insurance would cover such claims and that adequate insurance will continue to be available on acceptable terms to the Company in the future. The Company's business could be adversely affected by product liability claims. See "Product Liability." DEPENDENCE UPON KEY EMPLOYEES. The Company's success is dependent upon the retention of its executive officers and other key employees. Competition exists for qualified personnel, and the Company's success will depend in part upon attracting and retaining such personnel. Failure in these efforts ould have a material adverse effect on the Company's business, financial condition or results of operations. SHARES ELIGIBLE FOR FUTURE SALE. In November and December of 1995, the Company completed a private placement of 2,303,009 units (each unit representing one share of common stock and a warrant to purchase one share of common stock). The Company also granted a warrant to its placement agent in the private placement to purchase 137,086 shares of common stock. The shares issued in the 1995 private placement were registered for resale on a Registration Statement on Form S-3. The Company also granted registration rights with respect to the shares issuable upon exercise of the warrants. In December 1996, the Company completed a private placement of 3,434,493 units (each unit representing one share of common stock and a warrant to purchase one share of common stock). The Company also granted a warrant to its placement agent in the private placement to purchase 156,000 shares of common stock. The shares issued in the 1996 private placement and the underlying shares issuable upon exercise of the warrants were registered for resale on a Form S-3 Registration Statement. In June 1997, the Company completed a private placement of 1,744,186 units (each unit representing one share of common stock and a warrant to purchase one-half share of common stock). The Company has an obligation to seek registration on Form S-3 for the 1997 private placement shares and, if possible, the common shares underlying the warrants. Sales of substantial numbers of shares of common stock in the public market, or the availability of such shares for sale, could adversely affect the market price for the common stock and make it more difficult for the Company to raise funds through equity offerings in the future. POSSIBLE ADVERSE EFFECTS ON TRADING MARKET. The Common Stock is quoted on the NASDAQ National Market. There are a number of continuing requirements that must be met in order for the Common Stock offered hereby to remain eligible for quotation on the NASDAQ National Market or the NASDAQ Small Cap Market. In November 1996, NASDAQ approved changes to its quantitative and qualitative standards for issuers listing on NASDAQ, subject to public comment and approval by the Securities and Exchange Commission. Among the proposed changes are the elimination of the alternative test for issuers failing to meet the minimum bid price of $1.00 and an increase in the quantitative standards for both the NASDAQ National Market and the NASDAQ SmallCap Market. The failure to meet these maintenance criteria in the future could result in the delisting of the Company's Common Stock from NASDAQ. In such event, trading, if any, in the Common Stock may then continue to be conducted in the non-NASDAQ over-the-counter market. As a result, an investor may find it more difficult to dispose of, or to obtain accurate quotations as to the market value of, the Company's Common Stock. In addition, if the Common Stock were delisted from trading on NASDAQ and the trading price of the Common Stock were less than $5.00 per share, trading in the Common Stock would be subject to the requirements of certain rules promulgated under the Exchange Act, which require broker-dealers to make additional disclosures and to implement additional procedures in connection with any trades involving a stock defined as a penny stock. The additional burdens imposed upon broker-dealers may discourage broker-dealers from effecting transactions in penny stocks, which could reduce the liquidity of the shares of Common Stock and thereby have a material adverse effect on the trading market for the securities. POSSIBLE VOLATILITY OF STOCK PRICE. The market for the Company's common stock and for the securities of other early stage, small market- capitalization companies is highly volatile. The Company believes that factors such as quarter-to-quarter fluctuations in financial results, new product introductions by the Company or its competition, public announcements, changing regulatory environments, sales of Common Stock by certain existing shareholders and substantial product orders could contribute to the volatility of the price of the Company's Common Stock, causing it to fluctuate dramatically. General economic trends such as recessionary cycles and changing interest rates may also adversely affect the market price of the Company's Common Stock. See "Market for the Registrant's Common Equity and Related Stockholder Matters." Item 2. PROPERTIES The Company's principal offices are located in Portland, Oregon in approximately 24,000 square feet of leased office and manufacturing space under a lease which expires in September 2002. The monthly minimum lease obligation for this facility is approximately $15,000. These facilities include the Company's sales and administration offices and equipment, research and engineering facilities, a clean room assembly area, assembly line, testing facilities and a warehouse area. The Company leases additional warehouse space totalling approximately 5,000 square feet for finished goods storage and shipments to customers. This lease, which also expires in September 2002, has minimum monthly lease obligations totalling $1,900. The Company believes its current facilities will be sufficient to support its operations for the next 2-3 fiscal years. As the Company requires additional space to accommodate growth in its sales and manufacturing activities, it is the Company's intention to lease additional facilities adjacent to or near its present operations. The Company believes that, if necessary, it will be able to obtain facilities at rates and under terms comparable to those under the current leases. Item 3. LEGAL PROCEEDINGS None Item 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS None. PART II Item 5. MARKET FOR THE REGISTRANT'S COMMON EQUITY AND RELATED STOCKHOLDER MATTERS The Company's Common Stock is traded on the NASDAQ National Market under the Symbol "BJCT." The following table sets forth the high and low closing sale prices of the Company's Common Stock on the NASDAQ National Market.
High Low _____ _____ Fiscal year Ended March 31, 1995: First Quarter $3.00 $2.00 Second Quarter 4.13 3.25 Third Quarter 3.63 2.81 Fourth Quarter 2.50 1.50 Fiscal Year Ended March 31, 1996: First Quarter 3.00 1.44 Second Quarter 2.97 1.19 Third Quarter 2.81 1.81 Fourth Quarter 1.94 1.25 Fiscal Year Ended March 31, 1997: First Quarter 1.41 1.28 Second Quarter 1.03 0.97 Third Quarter 0.78 0.75 Fourth Quarter 0.78 0.63
The closing sale price on May 30, 1997, as reported on the NASDAQ National Market, was $0.91 per share. The Company has declared no dividends during its history and has no intention of declaring a dividend in the foreseeable future. As of May 30, 1997 the number of shareholders of record of the Company's Common Stock was 19,540,413. Item 6. SELECTED CONSOLIDATED FINANCIAL DATA FINANCIAL DATA The statement of operations and balance sheet data set forth below for the five fiscal years in the period ended March 31, 1997 have been derived from the consolidated financial statements of the Company. 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 detailed consolidated financial statements and notes thereto included elsewhere in this Report. SUMMARY FINANCIAL INFORMATION (in thousands, except per share data)
YEAR ENDED MARCH 31, 1997 1996 1995 1994 1993 ______ ______ ______ ______ ______ Statement of Operations Data: Revenues $2,235 $4,209 $2,924 $1,463 $1,146 Operating expenses 6,531 9,640 8,580 5,858 4,449 Net loss (4,296) (5,431) (5,656) (4,395) (3,303) Net loss per share (0.26) (0.39) (0.43) (0.39) (0.34) Shares used in per share calculation 16,705 14,074 13,167 11,230 9,686
AS OF MARCH 31, 1997 1996 1995 1994 1993 ______ ______ ______ ______ ______ Balance Sheet Data: Working capital $2,858 $4,327 $6,404 $12,593 $4,264 Total assets 7,088 7,519 9,498 13,836 5,727 Long-term debt - - - - - Shareholders' equity 5,766 6,027 7,964 13,377 4,752
The Company has declared no dividends during its history and has no intention of declaring a dividend in the foreseeable future. Item 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS OVERVIEW Operating losses have resulted in an accumulated deficit of approximately $34.3 million as of March 31, 1997. In fiscal 1995 and 1996, the Company incurred significantly increased costs associated with the production and sale of the Biojector 2000 system, including sales and marketing efforts, manufacturing ramp-up and inventory build-up. The Company has been working on a product cost reduction program which commenced phase-in during fiscal 1996 and results from the initial phase of which were reflected in fiscal 1997 operating performance. The Company's ability to achieve and sustain profitability will depend in part upon customer acceptance of the Biojector 2000 system, sustained product performance, implementing additional product cost reductions and attaining revenues sufficient to support profitable operations. In August 1994, Bioject signed an agreement with Health Management, Inc. (HMI), granting HMI exclusive rights to purchase Bioject's Needle-Free Injection Management System (trademark), the Biojector 2000, for use in the home healthcare market. In return for HMI's commitment to purchase a minimum of 8,000 Biojector units over the ensuing two years, the Company granted volume pricing discounts to HMI. During the term of the contract, the selling price of Biojectors to HMI exceeded their standard cost. During fiscal 1995 and 1996, the Company sold approximately 2,100 and 4,300 Biojectors to HMI for total sales revenue including syringes of $1.1 million and $2.2 million, respectively. HMI did not place the great majority of these Biojectors with patients pending completion of negotiations with pharmaceutical companies for certain pricing concessions for medication to be administered with the Biojectors. In January 1996 HMI requested that Bioject suspend shipments to HMI. In February 1996, the Company learned from HMI's press releases that HMI expected to default under its loans, to take significant write-offs for accounts receivable and inventories, planned operational consolidations, and would restate certain prior period financial statements. In fiscal 1997, although not obligated to do so, the Company agreed to repurchase certain of the HMI inventories, including up to 6,000 Biojector units, for cash and forgiveness of accounts receivable totalling $660,000. The repurchase of these inventories was at a substantial discount to the original selling price to HMI. In March 1994, the Company entered into an agreement with Schering AG, Germany, for the development of a self-injection device for delivery of Betaseron(R) to multiple sclerosis patients. During fiscal 1995, the Company developed a proof-of-concept prototype and demonstrated this prototype to Schering. The Company and Schering finalized product specifications. The Company also commenced development of the preproduction clinical prototype. During fiscal 1996, the Company delivered the preproduction clinical prototypes to Schering and worked on finalizing the production prototype design. During fiscal 1997, the Company entered into a supply agreement with Schering AG and commenced activities related to full production of the self injector. Schering loaned the Company a total of $1.6 million to purchase molds and tooling for production of the product. In January 1997, the Company received notice that its contract with Schering AG would be cancelled. Under provisions of the contract, Schering AG had the option of canceling the agreement if the FDA required extensive clinical studies beyond an originally planned safety study. Schering AG received a review letter from the FDA which would have required Schering to conduct additional material clinical studies in order to use non-traditional delivery mechanisms with its Betaseron(R) product. Under terms of the contract, Schering was required to convert its $1.6 million note due from Bioject into approximately 460,000 shares of Bioject common stock at a conversion price of $3.50 per share. In addition, $106,000 of accrued interest was converted into approximately 27,000 shares of Bioject common stock at a conversion price of $3.50 per share. Approximately 487,000 shares of Bioject stock are held by Schering AG. In addition, Schering is obligated to pay Bioject for the cost of product ordered through the date of cancellation of the contract. In January 1995, the Company signed a joint development agreement with Hoffmann-La Roche to develop proprietary drug delivery systems for Roche products. The agreement provides for Bioject to develop, manufacture and sell Biojector needle-free drug delivery systems designed to Roche specifications. In return, Bioject has granted Roche exclusive worldwide rights to distribute these systems and their components for use with certain Roche products. Hoffmann-La Roche Inc. is the United States affiliate of the multinational group of companies headed by Roche Holding of Basel, Switzerland, one of the world's leading research-intensive healthcare companies. As of 1995 fiscal year end, the Company had commenced design of a prototype device and had agreed with Roche on product specifications. During fiscal 1996, the Company developed and delivered to Roche preproduction prototypes for testing and developed the clinical preproduction prototypes which were delivered to Roche in April 1996. As of March 31, 1997, the Company and Hoffmann-LaRoche were finalizing their submission to obtain regulatory approval to market the product. Hoffmann- LaRoche was also gathering marketing information in order to sign a supply agreement. In February 1995, Hoffmann-La Roche paid a one-time licensing fee totalling $500,000 and the agreement provides that it will pay specified product development fees on an agreed upon schedule of which $900,000 was paid in fiscal 1996 and $250,000 was paid in fiscal 1997. Throughout fiscal 1994 and 1995, the Company's manufacturing processes were primarily manual. These processes did not permit the Company to produce its products at costs which would allow it to operate profitably. During fiscal 1996, the Company implemented a plan to increase manufacturing capacity and refine production methods to meet anticipated future demand and to reduce product costs. For the Biojector 2000, cost reduction efforts included converting from a two piece to a one piece housing, converting to continuous process manufacturing and implementing volume purchasing programs from suppliers. For the Biojector syringes, these efforts included increasing supplier mold capacity and automating final assembly and packaging. During fiscal 1997, the Company's manufacturing activities focused on retesting the devices repurchased from HMI to ensure their continuing compliance with new product standards and elective upgrade of certain of these units to current version configuration. Manufacturing also focused on finalizing product engineering and on planning for, designing and bringing up the new self injector device and syringe manufacturing lines in advance of product launch. The Company's revenues to date have not been sufficient to cover operating expenses. However, the Company believes that if its products achieve market acceptance and the volume of sales increases, and its product costs are reduced, its costs of goods as a percentage of sales will decrease and eventually the Company will generate net income. See "Forward Looking Statements" and "Business - Risk Factors." The level of sales required to generate net income will be affected by a number of factors including the pricing of the Company's products, its ability to attain efficiencies that can be attained through volume and automated manufacturing, and the impact of inflation on the Company's manufacturing and other operating costs. There can be no assurance that the Company will be able to successfully implement its manufacturing cost reduction program or sell its products at prices or in volumes sufficient to achieve profitability or offset increases in its costs should they occur. 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) length of time to close product sales, (ii) customer budget cycles, (iii) implementation of cost reduction measures, (iv) uncertainties and changes in purchasing due to third party payor policies and proposals relating to national healthcare reform, (v) timing and amount of payments under technology development agreements and (vi) timing of new product introductions by the Company and its competition. In the future, the Company may incur a non-cash charge to compensation expense in connection with the issuance of 100,000 shares of Common Stock to the Company's Chief Executive Officer. Under terms of his employment agreement, the Company's Chairman will receive 100,000 shares of common stock when the Company first achieves two consecutive quarters of positive earnings per share. Upon issuance of such shares the Company will record a non-cash charge to compensation at the fair market value of the stock on the last day of the quarter in which the shares are earned. During the next fiscal year, the Company will continue to focus its efforts on expanding sales, reducing the cost of its products, developing a 1.5 ml. injector for Hoffmann-La Roche, pursuing additional alliances with pharmaceutical companies and conserving its fiscal resources. The Company does not expect to report net income from operations in fiscal 1998. See "Forward Looking Statements" and "Risk Factors." RESULTS OF OPERATIONS Product sales increased from $1.5 million in fiscal 1995 to $3.1 million in fiscal 1996 and declined to $1.3 in fiscal 1997. Sales in fiscal 1995 consisted of $1.1 million of sales to Health Management Inc., and the remainder to hospitals, large clinics, individual physician offices and certain selected distributors. Sales in fiscal 1996 consisted of $2.3 million of sales to HMI with the remainder primarily to public health and flu immunization clinics. Sales in fiscal 1997, consisted of $1.1 million of sales to public health and flu immunization clinics with the balance to a strategic partner. License and technology fees varied from $1.4 million in fiscal 1995 to $1.2 million in fiscal 1996 and $966,000 in fiscal 1997. The fiscal 1995 fees included a one-time $500,000 licensing fee for access to the Company's technology received from Schering and a similar one-time $500,000 licensing fee received from Hoffmann-La Roche with the balance of the fiscal 1995 fees consisting of product development revenues recognized in connection with the Schering agreement. The fiscal 1996 and 1997 fees consisted principally of product development revenues recognized for work performed under the Schering and Hoffmann-La Roche agreements. Manufacturing expense consists of the costs of product sold and manufacturing overhead expense related to excess manufacturing capacity. The total of these costs varied from $3.4 million in fiscal 1995 to $5.2 million in fiscal 1996 and $2.2 million in fiscal 1997 due in part to changes in sales and, therefore, to changes in the total costs of product sold. The increase from 1995 to 1996 also reflects increased regulatory and quality assurance staff to support the higher level of manufacturing and increased depreciation expense associated with automated assembly equipment installed during fiscal 1996. The decrease in expense from fiscal 1996 to 1997 reflects reductions in materials and labor for injectors and syringes and reductions in fixed and variable manufacturing overhead expense. Fixed manufacturing overhead totalled $1.3 million, $1.9 million and $1.5 million in fiscal 1995, 1996 and 1997, respectively. Research and development expense increased slightly from to $1.4 million in fiscal 1995 to $1.5 million in fiscal 1996 and then decreased to $1.3 million in fiscal 1997. Fiscal 1995 expenditures related to work associated with development of the Schering device and to initial work on the Hoffmann-La Roche device. Fiscal 1996 expenditures related entirely to work performed under the Schering and Hoffmann-La Roche agreements. Fiscal 1997 expenditures related to final design and transfer to manufacturing of the Schering device and additional development work on the Hoffmann-LaRoche system. Costs vary from year to year depending on product activity. Selling, general and administrative expense totalled $4.2 million, $3.2 million and $3.2 million in fiscal 1995, 1996 and 1997, respectively. Fiscal 1995 included expenses incurred in connection with the chief executive officer transition totalling approximately $780,000 (or $0.06 per share) and to higher levels of legal, insurance, bad debt and certain promotional expenses. The decrease in fiscal 1996 resulted from planned reductions in overhead personnel. Sales and marketing expenses comprise slightly more than 50% of selling, general and administrative expenses in fiscal 1996 and 1997. Other income consists of earnings on available cash balances. Other income varied as a result of changes in cash balances and interest rates from year to year. LIQUIDITY AND CAPITAL RESOURCES Since its inception in 1985, the Company has financed its operations, working capital needs and capital expenditures primarily from private placements of securities, exercises of stock options, proceeds received from its initial public offering in 1986, proceeds received from a public offering of Common Stock in November 1993, licensing and technology revenues and more recently from sales of products. Net proceeds received upon issuance of securities from inception through March 31, 1997 totalled approximately $40.0 million. The Company has no long-term debt. Cash, cash equivalents and marketable securities totalled $4.1 million at March 31, 1996 and $2.1 million at March 31, 1997, which represented a decrease of $2.0 million from 1996 to 1997. The decrease resulted from operating losses and capital expenditures offset in part by net proceeds from a private placement of common stock and warrants in December 1996 and of long-term debt borrowing from Schering including accrued interest which was converted into 487,390 shares of common stock in February 1997. In June 1997, the Company completed private placement of its common stock and warrants totalling $750,000. Inventories increased from $1.3 million at March 31, 1996 to $1.7 million at March 31, 1997 due to the build-up of inventories to support anticipated future product sales and the repurchase of inventories from HMI. The Company has fixed commitments for facilities rent and equipment leases which total approximately $260,000 for fiscal 1998. The Company expended approximately $1.6 million for capital equipment in fiscal 1997. Substantially all of these expenditures related to ramp-up of manufacturing for the Schering product launch. These assets continue to be carried at their cost on the Company's balance sheet because the product is suitable for other home injection applications which the Company is pursuing. The Company expects to expend approximately $50,000 on non-manufacturing capital equipment additions in fiscal 1998. The Company believes that its current cash position and cash received from a private placement of common stock and warrants in June 1997, combined with revenues and other cash receipts will not be adequate to fund the Company's operations through the end of fiscal 1998. The Company has identified a number of potential financing sources and is pursuing them aggressively. See "Forward Looking Statements." Even if the Company is successful in raising additional financing unforeseen costs and expenses or lower than anticipated cash receipts from product sales or research and development activities could accelerate or increase the financing requirements. The Company has been successful in raising additional financing in the past and believes that sufficient funds will be available to fund future operations. See "Forward Looking Statements." However, there can be no assurance that the Company's efforts will be successful, and there can be no assurance that such financing will be available on terms which are not significantly dilutive to existing shareholders. Failure to obtain needed additional capital on terms acceptable to the Company, or at all, would significantly restrict the Company's operations and ability to continue product development and growth and materially adversely affect the Company's business. The Company has no banking line of credit or other established source of borrowing. The Company's independent accountants have qualified their opinion with respect to their audit of the Company's 1997 consolidated financial statements as the result of doubts concerning the Company's ability to continue as a going concern in the absence of additional financing. Item 8. CONSOLIDATED FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA TABLE OF CONTENTS TO FINANCIAL STATEMENTS Report of Independent Public Accountants Consolidated Balance Sheets at March 31, 1997 and 1996 Consolidated Statements of Operations for the years ended March 31, 1997, 1996 and 1995 Consolidated Statements of Shareholders' Equity for the years ended March 31, 1997, 1996 and 1995 Consolidated Statements of Cash Flows for the years ended March 31, 1997, 1996 and 1995 Notes to Consolidated Financial Statements Supplementary Data (none required) REPORT OF INDEPENDENT PUBLIC ACCOUNTANTS To the Board of Directors and Shareholders of Bioject Medical Technologies Inc: We have audited the accompanying consolidated balance sheets of Bioject Medical Technologies Inc. (an Oregon corporation) and subsidiaries as of March 31, 1997 and 1996, and the related consolidated statements of operations, shareholders' equity and cash flows for each of the three years in the period ended March 31, 1997. 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 generally accepted auditing standards. 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 financial statements referred to above present fairly, in all material respects, the financial position of Bioject Medical Technologies Inc. and subsidiaries, as of March 31, 1997 and 1996, and the results of their operations and their cash flows for each of the three years in the period ended March 31, 1997, in conformity with generally accepted accounting principles. The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1 to the financial statements, the Company has suffered recurring losses from operations and, at March 31, 1997, has an accumulated deficit of $34.3 million that raises substantial doubt about the Company's ability to continue as a going concern. Management's plan in regards to these matters is also described in Note 1. The financial statements do not include any adjustments relating to recoverability and classification of asset carrying amounts that might result should the Company be unable to continue as a going concern. /S/ ARTHUR ANDERSEN LLP Portland, Oregon May 2, 1997 (except with respect to the matter discussed in Note 7 for which the date is June 18, 1997) BIOJECT MEDICAL TECHNOLOGIES INC. AND SUBSIDIARIES CONSOLIDATED BALANCE SHEETS
March 31, 1997 1996 ____________ __________ ASSETS CURRENT ASSETS: Cash and cash equivalents $ 2,116,478 $ 3,098,251 Securities available for sale - 993,056 Accounts receivable, net of allowance for doubtful accounts of $27,500 and $55,000, respectively 311,856 424,859 Inventories 1,706,456 1,255,945 Other current assets 45,222 45,714 ____________ ___________ Total current assets 4,180,012 5,817,825 ____________ ___________ PROPERTY AND EQUIPMENT, at cost: Machinery and equipment 1,897,174 1,428,001 Production molds 1,798,630 777,353 Furniture and fixtures 176,897 163,116 Leasehold improvements 80,447 73,854 Capitalized Interest _____106,228 __________- 4,059,376 2,442,324 Less - accumulated depreciation (1,462,338) (1,048,638) ____________ ___________ 2,597,038 1,393,686 ____________ ___________ OTHER ASSETS 310,981 307,105 ____________ ___________ $ 7,088,031 $ 7,518,616 ============ =========== LIABILITIES AND SHAREHOLDERS' EQUITY CURRENT LIABILITIES: Accounts payable $ 659,973 $ 550,174 Accrued payroll 213,130 158,225 Other accrued liabilities 199,384 216,924 Deferred revenue 250,000 566,000 ____________ ___________ Total current liabilities 1,322,487 1,491,323 ____________ ___________ COMMITMENTS (Note 5) - - SHAREHOLDERS' EQUITY: Preferred stock, no par, 10,000,000 shares authorized; no shares issued and outstanding - - Common stock, no par, 100,000,000 shares authorized; issued and outstanding 19,540,413 and 15,585,232 shares at March 31, 1997 and 1996, respectively 40,035,736 36,001,158 Accumulated deficit (34,270,192) (29,973,865) ____________ ___________ Total shareholders' equity 5,765,544 6,027,293 ____________ ___________ $ 7,088,031 $ 7,518,616 ============ ===========
The accompanying notes are an integral part of these consolidated financial statements. BIOJECT MEDICAL TECHNOLOGIES INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF OPERATIONS
For the Year Ended March 31, 1997 1996 1995 _______________________________________ REVENUES: Net sales of products $ 1,269,882 $ 3,059,018 $1,479,948 Licensing/technology fees 965,500 1,150,000 1,444,000 ___________ __________ __________ 2,235,382 4,209,018 2,923,948 ___________ __________ __________ EXPENSES: Manufacturing 2,184,050 5,195,914 3,394,089 Research and development 1,275,580 1,486,607 1,427,861 Selling, general and administrative 3,177,228 3,168,618 4,186,549 Other (income) expense (105,149) (211,049) (428,402) ___________ ___________ __________ 6,531,709 9,640,090 8,580,097 ___________ ___________ __________ LOSS BEFORE TAXES (4,296,327) (5,431,072) (5,656,149) PROVISION FOR INCOME TAXES - - - ___________ ___________ ___________ NET LOSS $(4,296,327) $(5,431,072) $(5,656,149) =========== =========== =========== NET LOSS PER SHARE $ (0.26) $ (0.39) $ (0.43) ============ =========== =========== SHARES USED IN PER SHARE CALCULATION 16,705,274 14,074,349 13,167,301 ============ =========== ===========
The accompanying notes are an integral part of these consolidated financial statements BIOJECT MEDICAL TECHNOLOGIES INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY
COMMON STOCK ________________________ Accumulated Shares Amount Deficit Total __________ ___________ ____________ ___________ BALANCES, MARCH 31, 1994 13,158,074 $32,263,783 $(18,886,644) $13,377,139 Issuance of common stock in exchange for services 101,000 243,312 - 243,312 Net loss - - (5,656,149) (5,656,149) __________ __________ ____________ ___________ BALANCES, MARCH 31, 1995 13,259,074 32,507,095 (24,542,793) 7,964,302 Issuance of common stock in exchange for services 23,149 39,962 - 39,962 Issuance of common stock under a private placement in November and December 1995 2,303,009 3,454,101 - 3,454,101 Net loss - - (5,431,072) (5,431,072) __________ ___________ ____________ ___________ BALANCES, MARCH 31, 1996 15,585,232 36,001,158 (29,973,865) 6,027,293 Issuance of common stock in exchange for services 33,298 159,350 - 159,350 Issuance of common stock under a private placement in December 1996 3,434,493 2,163,000 - 2,163,000 Issuance of stock to Schering AG in exchange for debt 487,390 1,712,228 - 1,712,228 Net loss - - (4,296,327) (4,296,327) __________ ___________ _____________ ___________ BALANCES, MARCH 31, 1997 19,540,413 $40,035,736 $(34,270,192) $5,765,544 ========= ========= ========== ========
The accompanying notes are an integral part of these consolidated financial statements. BIOJECT MEDICAL TECHNOLOGIES INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF CASH FLOWS
For the Year Ended March 31, 1997 1996 1995 ____________________________________________ CASH FLOWS FROM OPERATING ACTIVITIES: Net loss $(4,296,327) $(5,431,072) $(5,656,149) Adjustments to net loss: Depreciation and amortization 443,700 520,714 247,183 Contributed capital for services 159,350 39,962 243,312 Net changes in assets and liabilities: Accounts receivable 113,003 305,864 (561,616) Inventories (450,511) (147,237) (144,982) Other current assets 492 6,435 (6,773) Accounts payable 109,799 (257,704) 593,498 Accrued payroll 54,905 (92,512) 52,436 Other accrued liabilities (17,540) (102,080) 273,305 Deferred revenue (316,000) 410,000 156,000 __________ ___________ ___________ Net Cash Used in Operating Activities (4,199,129) (4,747,630) (4,803,786) __________ ___________ ___________ CASH FLOWS FROM INVESTING ACTIVITIES: Securities purchased - (1,977,856) (6,951,390) Securities sold 993,056 4,974,268 9,795,130 Property and equipment (1,617,052) (597,100) (956,487) Other assets (33,876) (64,916) (65,723) __________ ___________ ___________ Net Cash Provided By (Used In) Investing Activities (657,872) 2,334,396 1,821,530 __________ ___________ ___________ CASH FLOWS FROM FINANCING ACTIVITIES: Cash proceeds from common stock 2,163,000 3,454,101 - Borrowing from long-term debt subsequently converted to common stock 1,712,228 - - __________ ___________ ___________ Net Cash Provided by Financing Activities 3,875,228 3,454,101 - __________ ___________ ___________ CASH AND CASH EQUIVALENTS: Net increase (decrease) in cash and cash equivalents (981,773) 1,040,867 (2,982,256) Cash and cash equivalents at beginning of year 3,098,251 2,057,384 5,039,640 __________ ___________ ___________ Cash and cash equivalents at end of year $2,116,478 $3,098,251 $2,057,384 ========== =========== ===========
The accompanying notes are an integral part of these consolidated financial statements. BIOJECT MEDICAL TECHNOLOGIES INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS 1. THE COMPANY: The consolidated financial statements of Bioject Medical Technologies Inc. and its subsidiaries (the "Company"), include the accounts of Bioject Medical Technologies Inc. ("BMT") and its wholly owned subsidiary, Bioject Inc. ("BI"). All significant intercompany transactions have been eliminated. BMT was incorporated on December 17, 1992 under the laws of the State of Oregon for the purpose of acquiring all of the outstanding common shares of Bioject Medical Systems, Ltd. ("BMSL") in exchange for an equivalent number of common shares of BMT stock under a plan of U.S. reincorporation approved by the Company's shareholders on November 20, 1992. BMSL was incorporated on February 14, 1985, under the laws of British Columbia, and terminated in July 1996. BI was incorporated on February 8, 1985, under the laws of the State of Oregon. The Company commenced operations in 1985 for the purpose of developing, manufacturing and distributing a new drug delivery system. Since its formation, the Company has been engaged principally in organizational, financing, research and development, and marketing activities. In the last quarter of fiscal 1993, the Company launched U.S. distribution of its Biojector 2000 system primarily to the hospital and large clinic market. The Company's products and manufacturing operations are subject to extensive government regulation, both in the U.S. and abroad. In the U.S., the development, manufacture, marketing and promotion of medical devices is regulated by the Food and Drug Administration ("FDA") under the Federal Food, Drug, and Cosmetic Act ("FFDCA"). In 1987, the Company received clearance from the FDA under Section 510(k) of the FFDCA to market a hand- held CO2-powered jet injection system. In June 1994, the Company received clearance from the FDA under 510(k) to market a version of its Biojector 2000 system in a configuration targeted at high volume injection applications. In March 1997, the Company received a 510(k) clearance from the FDA to market a version of its Biojector 2000 with certain additional features. Since its inception the Company has incurred operating losses and at March 31, 1997 has an accumulated deficit of approximately $34.3 million. The Company's revenues to date have been derived primarily from licensing and technology fees and more recently from sales of the Biojector 2000 system and Biojector syringes to public health clinics and flu immunization programs. Future revenues will depend upon acceptance and use by healthcare providers of the Company's jet injection technology. Uncertainties over government regulation and competition in the healthcare industry may impact healthcare provider expenditures and third party payer reimbursements and, accordingly, the Company cannot predict what impact, if any, subsequent healthcare reforms might have on its business. The Company's ability to achieve and sustain profitability will depend in part upon the customer acceptance of the Biojector 2000 system, sustained product performance, implementing additional product cost reductions and attaining revenues sufficient to support profitable operations. The Company's revenues to date have not been sufficient to cover operating expenses. However, the Company believes that if its products achieve market acceptance and the volume of sales increase, and its product costs are reduced, its cost of goods as a percentage of sales will decrease and eventually the Company will generate net income. The level of sales required to generate net income will be affected by a number of factors including the pricing of the Company's products, its ability to attain efficiencies that can be attained through volume and automated manufacturing, and the impact of inflation on the Company's manufacturing and other operating costs. There can be no assurance that the Company will be able to successfully implement its manufacturing cost reduction program or sell its products at prices or in volumes sufficient to achieve profitability or offset increase in its costs should they occur. The Company believes that its current cash position and cash received from a private placement of common stock and warrants on June 1997 (see note 7), combined with revenues and other cash receipts will not be adequate to fund the Company's operations through the end of fiscal 1998. The Company has identified a number of potential financing sources and is pursuing them aggressively. Even if the Company is successful in raising additional financing unforeseen costs and expenses or lower than anticipated cash receipts from product sales or research and development activities could accelerate or increase the financing requirements. The Company has been successful in raising additional financing in the past and believes that sufficient funds will be available to fund future operations. However, there can be no assurance that the Company's efforts will be successful, and there can be no assurance that such financing will be available on terms which are not significantly dilutive to existing shareholders. Failure to obtain needed additional capital on terms acceptable to the Company, or at all, would significantly restrict the Company's operations and ability to continue product development and growth and materially adversely affect the Company's business. The financial statements do not include any adjustments relating to the recoverability and classification of asset carrying amounts that might result should the Company be unable to continue as a going concern. 2. ACCOUNTING POLICIES: CASH EQUIVALENTS The Company considers cash equivalents to consist of short-term, highly liquid investments with an original maturity of less than three months. SECURITIES AVAILABLE FOR SALE The Company accounts for its investments in marketable securities in accordance with Financial Accounting Standards Board Statement No. 115, Accounting for Certain Investments in Debt and Equity Securities (SFAS 115). Under provisions of SFAS 115, the Company is required to classify and account for its security investments as trading securities, securities available for sale or securities held to maturity depending on the Company's intent to hold or trade the securities at time of purchase. As of March 31, 1997 and 1996, all securities held by the Company consisting entirely of short-term debt instruments were available for sale and, accordingly, are stated on the balance sheet at their fair market values which approximate cost. Realized gains or losses are determined on the specific identification method and are reflected in the accompanying financial statements. There were no significant realized gains or losses for fiscal 1997, 1996 and 1995. 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:
March 31, 1997 1996 __________ __________ Raw Materials $ 815,868 $ 697,694 Work in Process 9,763 12,467 Finished Goods 880,825 545,784 __________ __________ $1,706,456 $1,255,945 ========== ==========
PROPERTY AND EQUIPMENT For financial statement purposes, depreciation expense on property and equipment is computed on the straight-line method using the following lives: 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 terms of the lease or the estimated useful lives of the assets. OTHER ASSETS Other assets include costs incurred for the application of patents, net of amortization on a straight-line basis over 17 years. Accumulated amortization totalled $144,713 and $114,713 at March 31, 1997 and 1996, respectively. Amortization expense for the years ended March 31, 1997, 1996 and 1995 totalled $30,000, $20,000 and $31,000 respectively. ACCOUNTING FOR LONG-LIVED ASSETS In March 1995, the Financial Accounting Standards Board issued Statement No. 121, "Accounting for the Impairment of Long-Lived Assets and for Long-Lived Assets To Be Disposed Of"(SFAS 121), which requires the Company to review for impairment of its long-lived assets and certain identifiable intangibles whenever events or changes in circumstances indicate that the carrying amount of an asset might not be recoverable. In certain situations, an impairment loss would be recognized. SFAS 121 became effective for the Company's year ended March 31, 1997. The Company has studied the implications of SFAS 121 and, based on its evaluation, does not believe that an adjustment to the carrying value of its long-lived assets is necessary. REVENUE RECOGNITION FOR PRODUCT SALES The Company records revenue from sales of its products upon shipment. In fiscal 1997, 1996 and 1995, sales to one customer accounted for 17%, 75% and 74% of net sales of products, respectively. At March 31, 1997, 62% of accounts receivable were accounted for by one customer. RESEARCH AND DEVELOPMENT AND LICENSING/TECHNOLOGY REVENUES Licensing fees are recognized as revenue when due and payable. Product development revenue is deferred upon receipt and is recognized as revenue as qualifying expenditures are incurred. Expenditures for research and development are charged to expense as incurred. In March 1994, the Company entered into a joint development agreement with Schering AG, a major pharmaceutical manufacturer, for the development of an application specific self injection system. Under terms of the agreement, the Company received a $500,000 licensing fee in April 1994 and has received partial funding of product development expenses on an agreed schedule. In fiscal 1995, the Company received a total of $1.1 million from the pharmaceutical company, composed of $500,000 in licensing fees which were recognized as revenue during fiscal 1995 and $600,000 of Phase I product development revenues, $444,000 of which were recognized as revenue in fiscal 1995. In fiscal 1996, the Company received an additional $660,000 and a total of $751,000 was recognized as revenue. In fiscal 1997, the Company received a final product development payments totalling $349,500 and recognized revenue of $414,500. During fiscal 1997, the Company entered into a supply agreement with Schering AG and commenced activities related to full production of the self injector. Schering loaned the Company a total of $1.6 million to purchase molds and tooling for production of the product. In January 1997, the Company received notice that its contract with Schering AG would be cancelled. Under provisions of the contract, Schering AG had the option of canceling the agreement if the FDA required extensive clinical studies beyond an originally planned safety study. Schering AG received a review letter from the FDA which would have required Schering to conduct additional material clinical studies in order to use non-traditional delivery mechanisms with its Betaseron(R) product. Under terms of the contract, Schering was required to convert its $1.6 million note due from Bioject into approximately 460,000 shares of Bioject common stock at a conversion price of $3.50 per share. In addition, $106,000 of accrued interest was converted into approximately 27,000 shares of Bioject common stock at a conversion price of $3.50 per share. Schering is obligated to pay Bioject for the cost of product ordered through the date of cancellation of the contract. In January 1995, the Company entered into a joint development agreement with Hoffmann-La Roche, a major pharmaceutical manufacturer, for the development of application specific products. The Company received a licensing fee totalling $500,000 which was recognized as revenue in fiscal 1995. The Company is also receiving specified product development fees on an agreed upon schedule. In fiscal 1996, the Company received $900,000, of which $399,000 was recognized as revenue. In fiscal 1997, the Company received $250,000 in product development fees and recognized revenue of $501,000. INCOME TAXES The Company accounts for income taxes in accordance with Statement of Financial Accounting Standards No. 109, Accounting For Income Taxes (SFAS 109). Under the liability method specified by SFAS 109, the deferred tax assets and liabilities are determined based on the temporary differences between the financial statement and tax bases of assets and liabilities as measured by the enacted tax rates for the years in which the taxes are expected to be paid. At March 31, 1997, the Company had total deferred tax assets of approximately $13.0 million, consisting principally of available net operating loss carryforwards. No benefit for these operating losses has been reflected in the accompanying financial statements as they do not satisfy the recognition criteria set forth in SFAS 109. Total deferred tax liabilities were insignificant as of March 31, 1997. As of March 31, 1997, BMT has net operating loss carryforwards of approximately $799,000 available to reduce future federal taxable income, which expire in 2008 through 2012. BI has net operating loss carryforwards of approximately $34 million available to reduce future federal taxable income, which expire in 2001 through 2012. Approximately $3.0 million of BI's carryforwards were generated as a result of deductions related to exercises of stock options. When utilized, this portion of BI's carryforwards, 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. The principal differences between net operating loss carryforwards for tax purposes and the accumulated deficit result from capitalization of certain start-up costs and deductions related to the exercise of stock options for income tax purposes. USE OF ESTIMATES The preparation of financial statements in conformity with generally accepted accounting principles 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. Actual results could differ from those estimates. NET LOSS PER SHARE Net loss per share is computed based on the weighted average number of common shares outstanding during the period. The effects of common stock equivalents have not been included in the calculation as they would be anti- dilutive. 3. 401(K) RETIREMENT BENEFIT PLAN: The Company has a 401(k) Retirement Benefit Plan for its 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) and regulations thereunder. Effective January 1, 1996, the Company amended the plan to provide for voluntary employer matches of employee contributions up to 6% of salary and for discretionary profit sharing contributions to all employees. Such employer matches and contributions may be in either cash or Company common stock. For calendar 1996, the Company agreed to match 25% of employee contributions up to 6% of salary with Company stock. For calendar 1997, the Company has agreed to match 37.5% of employee contributions up to 6% of salary with Company stock. In fiscal 1997 and 1996, the Company recorded an expense of $25,000 and $4,800, respectively, related to voluntary employer matches under the 401(k) Plan. The Board of Directors has reserved up to 100,000 shares of common stock for these voluntary employer matches of which 31,630 shares have been committed through March 31, 1997. 4. SHAREHOLDERS' EQUITY: PREFERRED STOCK The Company has authorized 10 million shares of preferred stock, without par value, 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. As of March 31, 1997, no preferred shares had been issued by the Company. COMMON STOCK Holders of common stock are entitled to one vote for each share held of record 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. A total of 100,000 shares of common stock have been reserved by the Board of Directors for issuance to 401(k) plan participants (see note 3) of which 31,630 shares have been issued through March 31, 1997. ESCROWED SHARES As a result of the Company's initial public offering on the Vancouver Stock Exchange, 1.5 million shares of the Company had been held in escrow pursuant to an Escrow Agreement dated May 30, 1986, among the Company, WAM Partnership and the escrow agent, Montreal Trust Company. WAM Partnership was owned by Carl E. Wilcox, former Chairman and C.E.O., and J. Thomas Morrow, former Director, and managed by Mr. Wilcox. Both Mr. Wilcox and Mr. Morrow are founders of the Company. The Escrow Agreement provided that these escrowed shares would be released from escrow based on a cash flow formula or, alternatively, the shares could be released by making application and obtaining consent of the Superintendent of Brokers of British Columbia based on demonstrating company value. Under the escrow agreement, any shares not released by July 14, 1996 would be cancelled. In connection with Mr. Wilcox's resignation as chairman and chief executive officer of the Company (see Note 6), the Board of Directors granted Mr. Wilcox a special power of attorney to exclusively perform all acts necessary to obtain extension of the escrow and/or release of the WAM Partnership escrow shares. On June 3, 1996, the British Columbia Securities Commission informed the Company that its Executive Director (formerly the Superintendent of Brokers) consented to the release of all shares originally held in escrow. This means that the 1.5 million shares of common stock which had been held under this escrow arrangement are now held by the owners of the shares without risk of cancellation and may be sold. Upon release, approximately 150,000 of these shares were considered to have been contributed back to the Company and reissued to certain former employees in consideration for past services rendered on behalf of the Company. The Company recorded the shares as contributed capital with a corresponding non-cash charge to compensation expense at the fair market value of the stock on the date of issuance. Accordingly, a non-cash charge of $120,000 was recorded in the financial statements in the first quarter of fiscal 1997. STOCK OPTIONS Options may be granted to directors, officers and employees of the Company by the Board of Directors under terms of the Bioject Medical Technologies Inc. 1992 Stock Incentive Plan (the "Plan"), which was approved by the Company's shareholders on November 20, 1992 and adopted by the Board effective December 17, 1992. 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 the Company's common stock at prices and vesting as determined by a committee of the Board. Except for options whose terms were extended, options granted under a prior plan maintain their previous option price, vesting and expiration dates. As amended in fiscal 1995, a total of up to 3,000,000 shares of the Company's common stock including options outstanding at the date of initial shareholder approval of the Plan may be granted under the Plan. Options outstanding at March 31, 1997 expire through March 31, 2005. In October 1995, the Financial Accounting Standards Board issued Statement No. 123, Accounting for Stock-Based Compensation (SFAS 123), which establishes a fair value-based method of accounting for stock-based compensation plans and requires additional disclosures for those companies that elect not to adopt the new method of accounting. The Company has elected to continue to account for stock options under APB Opinion No. 25, Accounting for Stock Issued to Employees. However, as prescribed by SFAS 123 the Company has computed, for pro forma disclosure purposes, the value of all options granted during fiscal year 1997 and 1996 using the Black-Scholes option-pricing model, using the following weighted average assumptions for grants in 1997 and 1996: Risk-free interest rate 6% Expected dividend yield 0% Expected life 1.5 years Expected volatility 47% The total value of options granted during 1997 and 1996 would be amortized on a pro forma basis over the vesting period of the options. Options generally vest equally over three years. If the Company had accounted for these plans in accordance with SFAS 123, the Company's net loss and net loss per share would have increased as reflected in the following pro forma amounts (in thousands of $): Year ended March 31, 1997 1996 ______ ______ Net loss: As reported $(4,296) $(5,431) Pro forma (4,480) (5,541) Net loss per share: As reported (0.26) (0.39) Pro forma (0.27) (0.39) The above determination of proforma expense has been calculated consistent with SFAS 123 which does not take into consideration limitations on exercisability and transferability imposed by the Company's Stock Incentive Plan. Further, the valuation model is heavily weighted to stock price volatility, even with a declining stock price, which tends to increase calculated value. The actual value, if any, and, therefore, imputed proforma expense will vary based on the exercise date and the market price of the related common stock when sold. Stock option activity is summarized as follows:
Exercise Shares Price Amount _________ ____________ __________ Balances March 31, 1994 1,068,625 $3.20 - 5.00 $4,424,252 Options granted 1,427,250 2.60 - 4.75 5,387,632 Options exercised - - - Options canceled or expired (952,225) 3.00 - 5.00 (3,904,917) _________ ____________ ___________ Balances March 31, 1995 1,543,650 2.60 - 5.00 5,906,967 Options granted 1,316,439 1.25 - 4.50 3,129,177 Options exercised - - - Options canceled or expired (1,161,150) 2.34 - 5.00 (4,302,332) __________ ____________ ___________ Balances March 31, 1996 1,698,939 1.25 - 4.50 4,733,812 Options granted 705,525 1.00 - 1.30 830,006 Options exercised - Options canceled or expired (472,906) 1.00 - 4.00 (809,880) __________ ____________ ___________ Balances March 31, 1997 1,931,558 $1.00 - 4.50 $4,753,938 ========== ============ ===========
The following table sets forth as of March 31, 1997 the number of shares outstanding, exercise price, weighted average remaining contractual life, weighted average exercise price, number of exercisable shares and weighted average exercise price of exercisable options by groups of similar price and grant date:
OPTIONS OUTSTANDING OPTIONS EXERCISABLE Exercise Outstanding Weighted Average Weighted Exercisable Weighted Price shares Remaining Average Options Average at 3/31/97 Contractual Exercise Exercise Life(Years) Price Price - - ------ ----------- ----------- -------- ---------- -------- $1.00- 1.25 690,125 4.37 $1.17 476,688 $1.23 1.26 - 2.50 338,933 5.01 1.57 181,999 1.75 2.51 - 3.75 380,000 6.60 3.07 305,000 2.97 3.76 - 4.88 522,500 4.29 4.08 322,500 4.16
As of March 31, 1997, current officers and employees of the Company held approximately 1.0 million stock options, under the original terms of their issuance included above. Subsequent to year end, the Stock Option Committee of the Board of Directors approved a plan whereby employees may elect to reprice their outstanding options to an exercise price of $.75 per share subject to a 25% reduction in outstanding option shares and a deferral of exercisability until April 3, 1998. WARRANTS Warrant activity is summarized as follows:
Exercise Shares Price Amount _________ ____________ __________ Balances March 31, 1994 60,000 $ 4.50 $ 270,000 Warrants exercised - - - Warrants canceled or expired (60,000) 4.50 (270,000) _________ ____________ __________ Balances March 31, 1995 - - - Warrants issued expiring Nov. 2000 1,864,343 1.97 - 2.00 3,724,401 Warrants issued expiring Feb. 1998 575,752 2.00 1,151,505 Warrants exercised - - - Warrants canceled or expired - - - _________ ____________ __________ Balances March 31, 1996 2,440,095 1.97 - 2.00 4,875,906 Warrants issued expiring Dec. 2001 3,590,490 .82 - 1.00 3,562,413 Warrants exercised - - - Warrants canceled or expired - - - _________ ____________ __________ Balances March 31, 1997 6,030,585 $ .82 - 2.00 $8,438,319 ========== ============ ==========
5. COMMITMENTS: BI has operating leases for its manufacturing, sales and administrative facilities and warehouse facilities with options to renew for an additional five-year term upon expiration. BI also leases office equipment under operating leases for periods up to five years. At March 31, 1997, future minimum payments under noncancellable operating leases with terms in excess of one year are as follows:
Year Ending March 31, Facilities Equipment __________ _________ 1998 $212,000 $45,000 1999 219,000 24,000 2000 220,000 4,000 2001 235,000 3,000 2002 236,000 - 118,000 - Thereafter
Lease expense for the years ended March 31, 1997, 1996 and 1995 totalled $283,000,$221,000, and $214,000, respectively. 6. RELATED PARTY TRANSACTIONS: On January 12, 1995, the Board of Directors announced the resignation of the Company's Chairman and Chief Executive Officer, Carl E. Wilcox. In consideration for Mr. Wilcox's long service to the Company, the Board granted Mr. Wilcox 100,000 shares of common stock valued at $241,000 and cash compensation totalling $247,000. The Board agreed to pay Mr. Wilcox $20,000 per year for two years under a covenant not-to-compete. The Board also vested 200,000 previously granted option shares at $4.00 per share and extended the expiration date to January 14, 1998. The Board granted Mr. Wilcox a special power of attorney to exclusively perform all acts necessary to obtain extension and/or release of the WAM Partnership escrow shares. In addition, the Board agreed to pay up to $10,000 of costs associated with such extension and/or release. On June 3, 1996, the British Columbia Securities Commission informed the Company that release of the escrow shares had been granted (see Note 4). The value of the severance agreement totalling $488,000 was recorded as general and administrative expense in the accompanying financial statements in fiscal 1995. 7. SUBSEQUENT EVENT: On June 18, 1997, the Company completed a private placement of units (one unit consisting of one share of common stock and one-half warrant for purchase of common stock at $.71 per share)for total proceeds of $750,000. The Company has committed to register the $1.7 million shares and, if possible, the common shares underlying the 872,000 warrants issued in the private placement on a Form S-3 registration statement within 20 days of close of the transaction. Item 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE None. PART III The Company has omitted from Part III the information that will appear in the Company's definitive proxy statement for its annual meeting of shareholders to be held on September 11, 1997 (the "Proxy Statement"), which will be filed within 120 days after the end of the Company's fiscal year pursuant to Regulation 14A. Item 10. DIRECTORS AND EXECUTIVE OFFICERS OF THE REGISTRANT The information required by this Item is incorporated by reference to the information under the caption "DIRECTORS AND EXECUTIVE OFFICERS OF THE REGISTRANT" in the Proxy Statement. Item 11. EXECUTIVE COMPENSATION The information required by this Item is incorporated by reference to the information under the caption "EXECUTIVE COMPENSATION AND OTHER TRANSACTIONS" in the Proxy Statement. Item 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT The information required by this Item is incorporated by reference to the information under the caption "SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT" in the Proxy Statement. Item 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS The information required by this Item is incorporated by reference to the information under the caption "CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS" in the Proxy Statement. PART IV Item 14. EXHIBITS, FINANCIAL STATEMENT SCHEDULES AND REPORTS ON FORM 8-K (a) The following documents are filed as a part of this report: (1) Consolidated Financial Statements and Report of Independent Public Accountants are included under Item 8, in Part II. (2) Consolidated Financial Statement Schedules and Report of Independent Public Accountants on those schedules: None required (3) Exhibits: The following exhibits are filed as part of this report. An asterisk (*) beside the exhibit number indicates the subset of the exhibits containing each management contract, compensatory plan, or arrangement required to be identified separately in this report.
Exhibit Number Exhibit Description _______ _________________________________________________________________ 3.1 Articles of Incorporation of Bioject Medical Technologies Inc. incorporated by reference to the same exhibit number of the Company's Form 10-K for the year ended January 31, 1993. 3.2 Amended and Restated By-laws of Bioject Medical Technologies Inc. Incorporated by reference to the same exhibit number of the Company's Form 10-Q for the quarter ended September 30, 1994. 4.3* Bioject Medical Technologies Inc. 1992 Stock Incentive Plan, as amended through July 25, 1996. 10.4 Lease Agreement dated March 21, 1989 between Spieker-Hosford- Eddy-Souther #174, Limited Partnership and Bioject Inc. for the Portland, Oregon facility incorporated by reference to the same exhibit number of Company's Form 10-K for the year ended January 31, 1989. 10.4.1 Amended Lease Agreement dated June 18, 1992 between Bridgeport Woods Investors (successors in interest to Spieker-Hosford-Eddy- Souther #174 Limited Partnership) and Bioject Inc. for the Portland, Oregon facility incorporated by reference to the same exhibit number of the Company's Form 10-K for the year ended January 31, 1993. 10.4.2 Lease Agreement dated September 10, 1996 between Bridgeport Woods Business park and Bioject Inc. for the Portland, Oregon facility. Incorporated by reference to the same exhibit number of the Company's Form 10-Q for the period ended September 30, 1996. 10.5 Lease Extension Agreement dated October 4, 1994, between Earl J. Itel and Loris Itel Trust and Bioject, Inc., for the 6000 sq. ft. Tualatin, Oregon warehouse. Incorporated by reference to the same exhibit number of the Company's Form 10-Q/A for the period ended December 31, 1996. 10.7* Executive Employment Contract with Peggy J. Miller, dated January 18, 1993 incorporated by reference to the same exhibit number of the Company's Form 10-K for the year ended January 31, 1993. 10.8* Executive Employment Contract with J. Michael Redmond, dated February 8, 1996. Incorporated by reference to the same exhibit number of the Company's Form 10-K for the year ended March 31, 1996. 10.14 Common Stock Purchase Agreement between Eli Lilly and Company and Bioject Medical Systems Ltd. dated April 29, 1992 incorporated by reference to the same exhibit number of Company's Form 8, dated May 28, 1992, amending Company's Form 10-K for the year ended January 31, 1992. 10.17 Development and Licensing Agreement between Eli Lilly & Company and Bioject Inc., dated April 29, 1992 incorporated by reference to the same exhibit number of Company's Form 8, dated October 9, 1992, amending Company's Form 10-Q for the quarter ended April 30, 1992. 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. 10.17.1 Amendment to Development and Licensing Agreement between Eli Lilly and Company and Bioject Inc., effective May 5, 1993 incorporated by reference to the same exhibit number of Company's Form S-1, No. 33-68846, dated November 1, 1993. 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 406 under the Securities Act of 1933, as amended. 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. 10.23 Development and Licensing Agreement between Schering, AG, Bioject Inc. and Bioject Medical Technologies Inc. dated March 28, 1994 incorporated by reference to the same exhibit number of the Company's Form 10-K for the year ended March 31, 1994. Confidential treatment has been granted with respect to certain portions of this exhibit pursuant to an Application for Confidential Treatment filed with the Commission under Rule 24b-2 under the Securities exchange Act of 1934, as amended. 10.26 Heads of Agreement between Hoffmann-La Roche Inc. and Bioject Inc. dated January 10, 1995. 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. 10.27* Employment Agreement with James C. O'Shea dated October 3, 1995 incorporated by reference to the same exhibit number of the Company's Form 10-Q for the quarter ended September 30, 1995. 10.28 Form of Amended and Restated Registration Rights Agreement between Bioject Medical Technologies Inc. and the participants in the 1995 private placement incorporated by reference to exhibit 4.2 of the Company's Registration Statement on Form S-3 (No. 33-80679). 10.29 Form of Amended and Restated Series "A" Common Stock Purchase Warrant incorporated by reference to exhibit 4.3 of the Company's Registration Statement on Form S-3 (No. 33-80679). 10.30 Form of Series "B" Common Stock Purchase Warrant incorporated by reference to exhibit 4.4. of the Company's Registration Statement on Form S-3 (No. 33-80679). 10.31 Form of Amended and Restated Series "C" Common Stock Purchase Warrant incorporated by reference to exhibit 4.5 of the Company's Registration Statement on Form S-3 (No. 33-80679). 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. 10.32 Supply Agreement dated June 26, 1996 between Bioject Inc. and Schering Aktiengesellschaft. Incorporated by reference to the same exhibit number of the Company's Form 8-K/A dated June 26, 1996. Confidential treatment has been granted with respect to certain portions of this exhibit pursuant to an Application for Confidential Treatment filed with the Commission under Rule 24b-2 under the Securities exchange Act of 1934, as amended. 10.32.1 Security Agreement dated June 26, 1996 between Bioject Inc. and Schering Aktiengesellschaft. Incorporated by reference to the same exhibit number of the Company's Form 10-Q for the period ended June 30, 1996. 10.33 Form of Series "D" Common Stock Purchase Warrant. Incorporated by reference to exhibit 4.6 of the Company's form 8-K dated December 11, 1996. 10.34 Form of Series "E" Common Stock Purchase Warrant. Incorporated by reference to exhibit 4.7 of the Company's Form 8-K dated December 11, 1996. 10.35 Form of Registration Rights Agreement between Bioject Medical Technologies Inc. and the participants in the 1996 private placement. Incorporated by reference to exhibit 4.8 of the Company's Form 8-K dated December 11, 1996. 10.36 Form of Series "F" Common Stock Purchase Warrant. 10.37 Form of Series "G" Common Stock Purchase Warrant. 10.38 Form of Registration Rights Agreement between Bioject Medical Technologies Inc. and the participants in the 1997 private placement. 21.1 List of Subsidiaries incorporated by reference to Exhibit No. 22.1 of Company's Form 10-K for the year ended January 31, 1993. 23.2 Consent of Independent Public Accountants 27.1 Financial Data Schedule
(b) Forms 8K filed since last report: Form 8-K January 14, 1997 reporting unaudited proforma results of operations and financial position as of November 30,1996 reflecting results of the private placement completed in December 1996. Form 8-K January 28, 1997 reporting cancellation of the Schering contract. 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: BIOJECT MEDICAL TECHNOLOGIES INC. (Registrant) By: /S/ JAMES C. O'SHEA James C. O'Shea Chairman of the Board, President and Chief 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 the dates shown. SIGNATURE TITLE /S/ JAMES C. O'SHEA Chairman of the Board, President James C. O'Shea and Chief Executive Officer /S/ PEGGY J. MILLER Vice President, Chief Financial Peggy J. Miller Officer and Secretary/Treasurer /s/ DAVID H. DE WEESE Director David H. de Weese /S/ GRACE K. FEY Director Grace K. Fey /S/ WILLIAM A. GOUVEIA Director William A. Gouveia /S/ ERIC T. HERFINDAL Director Eric T. Herfindal /S/ RICHARD PLESTINA Director Richard Plestina /S/ JOHN RUEDY, M.D. Director John Ruedy, M.D. INDEX TO EXHIBITS
Exhibit Number Exhibit Description _______ __________________________________________________________ 4.3 Bioject Medical Technologies, Inc. 1992 Stock Incentive Plan, as amended through July 25, 1996. 10.36 Form of Series "F" Common Stock Purchase Warrant. 10.37 Form of Series "G" Common Stock Purchase Warrant. 10.38 Form of Registration Rights Agreement between Bioject Medical Technologies Inc. and the participants in the 1997 private placement. 23.2 Consent of Independent Public Accountants 27.1 Financial Data Schedule
EXHIBIT 23.2 CONSENT OF INDEPENDENT PUBLIC ACCOUNTANTS As independent public accountants, we hereby consent to the incorporation of our report included in this Form 10-K into the Company's previously filed Registration Statements on Form S-3, File No. 33-80679 and File No. 333-18933, and Registration Statements on Form S-8, File Nos. 33-94400, 33-56454 and 33-42156. /S/ ARTHUR ANDERSEN LLP Portland, Oregon June 27, 1997 [ARTICLE] 5
EX-27.1 2 FINANCIAL DATA SCHEDULE. WARNING: THE EDGAR SYSTEM ENCOUNTERED ERROR(S) WHILE PROCESSING THIS SCHEDULE. EXHIBIT 27.1 THIS SCHEDULE CONTAINS SUMMARY FINANCIAL INFORMATION EXTRACTED FROM THE CONSOLIDATED BALANCE SHEETS AND THE CONSOLIDATED STATEMENTS OF OPERATIONS FILED AS PART OF THE ANNUAL REPORT ON FORM 10-K AND IS QUALIFIED IN ITS ENTIRETY BY REFERENCE TO SUCH ANNUAL REPORT ON FORM 10-K. 1 YEAR MAR-31-1997 APR-01-1996 MAR-31-1997 2,116,478 0 311,856 27,500 1,706,456 4,180,012 4,059,376 1,462,338 7,088,031 1,322,487 0 0 0 40,035,376 0 7,088,031 1,269,882 2,235,382 2,184,050 2,184,050 4,347,659 0 0 (4,296,327) 0 (4,296,327) 0 0 0 (4,296,327) (0.26) (0.26)
EX-10.36 3 FORM OF SERIES F COMMON STOCK PURCHASE WARRANT. Exhibit 10.36 THIS WARRANT AND THE SECURITIES ISSUABLE UPON EXERCISE HEREOF HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED, OR ANY APPLICABLE STATE LAWS, AND NO INTEREST THEREIN MAY BE SOLD, DISTRIBUTED, ASSIGNED, oFFERED, PLEDGED OR OTHERWISE TRANSFERRED UNLESS THERE IS AN EFFECTIVE REGISTRATION STATEMENT UNDER SUCH ACT AND APPLICABLE STATE SECURITIES LAWS COVERING ANY SUCH TRANSACTION OR SUCH TRANSACTION IS EXEMPT FROM THE REGISTRATION REQUIREMENTS OF SUCH ACT AND LAWS, SUCH COMPLIANCE, AT THE OPTION OF THE CORPORATION, TO BE EVIDENCED BY AN OPINION OF WARRANTHOLDER'S COUNSEL, IN FORM ACCEPTABLE TO THE CORPORATION, THAT NO VIOLATION OF SUCH REGISTRATION PROVISIONS WOULD RESULT FROM ANY PROPOSED TRANSFER OR ASSIGNMENT. SERIES "F" COMMON STOCK PURCHASE WARRANT Bioject Medical Technologies Inc. THIS CERTIFIES that for good and valuable consideration received, _________, a(n) individual or registered assigns, is entitled, upon the terms and subject to the conditions hereinafter set forth, to acquire from Bioject Medical Technologies Inc., an Oregon corporation (the "Corporation") up to _______ fully paid and nonassessable shares of common stock, without par value, of the Corporation ("Warrant Stock") at a purchase price per share (the "Exercise Price") of $0.50. 1. Term of Warrant Subject to the terms and conditions set forth herein, this Warrant shall be exercisable, in whole or from time to time part, at any time on or after the date hereof and at or prior to 11:59 p.m., Pacific Standard Time, on May 15, 2002 (the "Expiration Time"). Notwithstanding the foregoing, at any time from the date of this Warrant, the Corporation shall have the right, except as may be limited by law, other agreements or herein, to call this Warrant for exercise, in whole or in part, by mailing written notice by United States mail to the registered holder hereof if the average closing bid price for the Corporation's common stock, as quoted by the Nasdaq National Market or any other established over-the-counter quotation service, is equal to or greater than $5.00 per share, as adjusted pursuant to Section 11 hereof, for any consecutive period of twenty trading days ending five business days prior to the date of notice of redemption. In such event, this Warrant shall expire and cease to be exercisable at 11:59 p.m. Pacific Standard Time, of the thirtieth day after the date of mailing of the notice. 2. Exercise of Warrant The purchase rights represented by this Warrant are exercisable by the registered holder hereof, in whole or in part, at any time and from time to time at or prior to the Expiration Time by the surrender of this Warrant and the Notice of Exercise form attached hereto duly executed to the office of the Corporation at 7620 S.W. Bridgeport Road, Portland, Oregon 97224 (or such other office or agency of the Corporation as it may designate by notice in writing to the registered holder hereof at the address of such holder appearing on the books of the Corporation), and upon payment of the Exercise Price for the shares thereby purchased (by cash or by check or bank draft payable to the order of the Corporation or by cancellation of indebtedness of the Corporation to the holder hereof, if any, at the time of exercise in an amount equal to the purchase price of the shares thereby purchased); whereupon the holder of this Warrant shall be entitled to receive from the Corporation a stock certificate in proper form representing the number of shares of Warrant Stock so purchased. 3. Issuance of Shares; No Fractional Shares of Scrip Certificates for shares purchased hereunder shall be delivered to the holder hereof by the Corporation's transfer agent at the Corporation's expense within a reasonable time after the date on which this Warrant shall have been exercised in accordance with the terms hereof. Each certificate so delivered shall be in such denominations as may be requested by the holder hereof and shall be registered in the name of such holder or, subject to applicable laws, other name as shall be requested by such holder. If, upon exercise of this Warrant, fewer than all of the shares of Warrant Stock evidenced by this Warrant are purchased prior to the Expiration Time, one or more new warrants substantially in the form of, and on the terms in, this Warrant will be issued for the remaining number of shares of Warrant Stock not purchased upon exercise of this Warrant. The Corporation hereby represents and warrants that all shares of Warrant Stock which may be issued upon the exercise of this Warrant will, upon such exercise, be duly and validly authorized and issued, fully paid and nonassessable and free from all taxes, liens and charges in respect of the issuance thereof (other than liens or charges created by or imposed upon the holder of the Warrant Stock). The Corporation agrees that the shares so issued shall be and be deemed to be issued to such holder as the record owner of such shares as of the close of business on the date on which this Warrant shall have been surrendered for exercise in accordance with the terms hereof. No fractional shares or scrip representing fractional shares shall be issued upon the exercise of this Warrant. With respect to any fraction of a share called for upon the exercise of this Warrant, an amount equal to such fraction multiplied by the then current price at which each share may be purchased hereunder shall be paid in cash to the holder of this Warrant. 4. Charges, Taxes and Expenses Issuance of certificates for shares of Warrant Stock upon the exercise of this Warrant shall be made without charge to the holder hereof for any issue or transfer tax or other incidental expense in respect of the issuance of such certificate, all of which taxes and expenses shall be paid by the Corporation, and such certificates shall be issued in the name of the holder of this Warrant or in such name or names as may be directed by the holder of this Warrant; provided, however, that in the event certificates for shares of Warrant Stock are to be issued in a name other than the name of the holder of this Warrant, this Warrant when surrendered for exercise shall be accompanied by the Assignment Form attached hereto duly executed by the holder hereof. 5. No Rights as Shareholders This Warrant does not entitle the holder hereof to any voting rights or other rights as a shareholder of the Corporation prior to the exercise hereof. 6. Registration Rights The Warrant Stock purchasable upon exercise of this Warrant has not been registered under the Securities Act of 1933 or any state securities law. The Corporation shall have no obligation to register such Warrant Stock for resale unless the Offering as contemplated by the Agreement between , (" "), and the Corporation dated May 15, 1997 is completed and only on the same terms as any registration rights for shares issuable upon exercise of warrants are included in such Offering. The foregoing notwithstanding, any obligation undertaken by the Corporation to register the Warrant Stock shall be limited to the Corporation's use of its best efforts to do so, and in no event shall the Corporation be required to file or maintain the effectiveness of a registration statement on Form S-1 unless a Form S-1 is filed and maintained effective with respect to shares issuable upon exercise of warrants issued in such Offering. 7. Exchange and Registry of Warrant This Warrant is exchangeable, upon the surrender hereof by the registered holder at the above-mentioned office or agency of the Corporation, for a new Warrant of like tenor and dated as of such exchange. The Corporation shall maintain at the above-mentioned office or agency a registry showing the name and address of the registered holder of this Warrant. This Warrant may be surrendered for exchange, transfer or exercise, in accordance with its terms, at such office or agency of the Corporation, and the Corporation shall be entitled to rely in all respects, prior to written notice to the contrary, upon such registry. 8. Loss, Theft, Destruction or Mutilation of Warrant Upon receipt by the Corporation of evidence reasonably satisfactory to it of the loss, theft, destruction or mutilation of this Warrant, and in case of loss, theft or destruction of indemnity or security reasonably satisfactory to it, and upon reimbursement to the Corporation of all reasonable expenses incidental thereto, and upon surrender and cancellation of this Warrant, if mutilated, the Corporation will make and deliver a new Warrant of like tenor and dated as of such cancellation, in lieu of this Warrant. 9. Saturdays, Sundays and Holidays If the last or appointed day for the taking of any action or the expiration of any right required or granted herein shall be a Saturday or a Sunday or shall be a legal holiday, then such action may be taken or such right may be exercised on the next succeeding day not a Saturday, Sunday or legal holiday. 10. Merger, Sale of Assets, Etc. If at any time the Corporation proposes to merge or consolidate with or into any other corporation, effect any reorganization, or sell or convey all or substantially all of its assets to any other entity, then, as a condition of such reorganization, consolidation, merger, sale or conveyance, the Corporation or its successor, as the case may be, shall enter into a supplemental agreement to make lawful and adequate provision whereby the holder shall have the right to receive, upon exercise of the Warrant, the kind and amount of equity securities which would have been received upon such reorganization, consolidation, merger, sale or conveyance by a holder of a number of shares of common stock equal to the number of shares issuable upon exercise of the Warrant immediately prior to such reorganization, consolidation, merger, sale or conveyance. If the property to be received upon such reorganization, consolidation, merger, sale or conveyance is not equity securities, the Corporation shall give the holder of this Warrant fifteen (15) business days prior written notice of the proposed effective date of such transaction, and if this Warrant has not been exercised by or on the effective date of such transaction, it shall terminate. 11. Subdivision, Combination, Reclassification, Conversion, Etc. If the Corporation at any time shall, by subdivision, combination, reclassification of securities or otherwise, change the Warrant Stock into the same or a different number of securities of any class or classes, this Warrant shall thereafter entitle the holder to acquire such number and kind of securities as would have been issuable in respect of the Warrant Stock (or other securities which were subject to the purchase rights under this Warrant immediately prior to such subdivision, combination, reclassification or other change) as the result of such change if this Warrant had been exercised in full for cash immediately prior to such change. The Exercise Price hereunder shall be adjusted if and to the extent necessary to reflect such change. If the Warrant Stock or other securities issuable upon exercise hereof are subdivided or combined into a greater or smaller number of shares of such security, the number of shares issuable hereunder shall be proportionately increased or decreased, as the case may be, and the Exercise Price shall be proportionately reduced or increased, as the case may be, in both cases according to the ratio which the total number of shares of such security to be outstanding immediately after such even bears to the total number of shares of such security outstanding immediately prior to such event. The Corporation shall give the holder prompt written notice of any change in the type of securities issuable hereunder, any adjustment of the Exercise Price for the securities issuable hereunder, and any increase or decrease in the number of shares issuable hereunder. 12. Transferability; Compliance with Securities Laws (a) This Warrant may not be transferred or assigned in whole or in part without compliance with all applicable federal and state securities laws by the transferor and transferee (including the delivery of investment representation letters and legal opinions reasonably satisfactory to the Corporation, if requested by the Corporation). Subject such restrictions, prior to the Expiration Time, this Warrant and all rights hereunder are transferable by the holder hereof, in whole or in part, at the office or agency of the Corporation referred to in Section 1 hereof. Any such transfer shall be made in person or by the holder's duly authorized attorney, upon surrender of this Warrant together with the Assignment Form attached hereto properly endorsed. (b) The Holder of this Warrant, by acceptance hereof, acknowledges that this Warrant and the Warrant Stock issuable upon exercise hereof are being acquired solely for the holder's own account and not as a nominee for any other party, and for investment, and that the holder will not offer, sell or otherwise dispose of this Warrant or any shares of Warrant Stock to be issued upon exercise hereof except under circumstances that will not result in a violation of the Securities Act of 1933, as amended, or any state securities laws. Upon exercise of this Warrant, the holder shall, if requested by the Corporation, confirm in writing, in a form satisfactory to the Corporation, that the shares of Warrant Stock so purchased are being acquired solely for holder's own account and not as a nominee for any other party, for investment, and not with a view toward distribution or resale. (c) Except as contemplated in the Registration Rights Agreement, the Warrant Stock has not been and will not be registered under the Securities Act of 1933, as amended, and this Warrant may not be exercised except by (i) the original purchaser of this Warrant from the Corporation or (ii) an "accredited investor" as defined in Rule 501(a) under the Securities Act of 1933, as amended. Each certificate representing the Warrant Stock or other securities issued in respect of the Warrant Stock upon any stock split, stock dividend, recapitalization, merger, consolidation or similar event, shall be stamped or otherwise imprinted with a legend substantially in the following form (in addition to any legend required under applicable securities laws): THE SECURITIES REPRESENTED HEREBY HAVE NOT BEEN REGISTERED UNDER UNITED STATES FEDERAL OR STATE SECURITIES LAWS AND MAY NOT BE OFFERED FOR SALE, SOLD OR OTHERWISE TRANSFERRED OR ASSIGNED FOR VALUE, DIRECTLY OR INDIRECTLY, NOR MAY THE SECURITIES BE TRANSFERRED ON THE BOOKS OF THE CORPORATION, WITHOUT REGISTRATION OF SUCH SECURITIES UNDER ALL APPLICABLE UNITED STATES FEDERAL OR STATE SECURITIES LAWS OR COMPLIANCE WITH AN APPLICABLE EXEMPTION THEREFROM, SUCH COMPLIANCE, AT THE OPTION OF THE CORPORATION, TO BE EVIDENCED BY AN OPINION OF SHAREHOLDER'S COUNSEL, IN FORM ACCEPTABLE TO THE CORPORATION, THAT NO VIOLATION OF SUCH REGISTRATION PROVISIONS WOULD RESULT FROM ANY PROPOSED TRANSFER OR ASSIGNMENT. 13. Representations and Warranties The Corporation hereby represents and warrants to the holder hereof that: (a) during the period this Warrant is outstanding, the Corporation will reserve from its authorized and unissued common stock a sufficient number of shares to provide for the issuance of Warrant Stock upon the exercise of this Warrant; b) the issuance of this Warrant shall constitute full authority to the Corporation's officers who are charged with the duty of executing stock certificates to execute and issue the necessary certificates for the shares of Warrant Stock issuable upon exercise of this Warrant; (c) the Corporation has all requisite legal and corporate power to execute and deliver this Warrant, to sell and issue the Warrant Stock hereunder, to issue the common stock issuable upon exercise of the Warrant Stock and to carry out and perform its obligations under the terms of this Warrant; and (d) all corporate action on the part of the Corporation, its directors and shareholders necessary for the authorization, execution, delivery and performance of this Warrant by the Corporation, the authorization, sale, issuance and delivery of the Warrant Stock, the grant of registration rights as provided herein and the performance of the Corporation's obligations hereunder has been taken; (e) the Warrant Stock, when issued in compliance with the provisions of this Warrant and the Corporation's Articles of Incorporation (as they may be amended from time to time (the "Articles")), will be validly issued, fully paid and nonassessable, and free of all taxes, liens or encumbrances with respect to the issue thereof, and will be issued in compliance with all applicable federal and state securities laws; and (f) the issuance of the Warrant Stock will not be subject to any preemptive rights, rights of first refusal or similar rights. 14. Corporation The Corporation will not, by amendment of its Articles or through any reorganization, recapitalization, transfer of assets, consolidation, merger, dissolution, issue or sale of securities or any other action, avoid or seek to avoid the observance or performance of any of the terms to be observed or performed hereunder by the Corporation, but will at all times in good faith assist in the carrying out of all the provisions of this Warrant and in the taking of all such action as may be necessary or appropriate in order to protect the rights of the holder of the Warrant against impairment. 15. Governing Law This Warrant shall be governed by and construed in accordance with the laws of the State of Oregon. IN WITNESS WHEREOF, the Corporation has caused this Warrant to be executed by its duly authorized officers. Dated:_____________, 1997 BIOJECT MEDICAL TECHNOLOGIES INC. By: Name: Peggy J. Miller Title: Vice President, Chief Financial Officer & Secretary NOTICE OF EXERCISE To: Bioject Medical Technologies Inc. (1) The undersigned hereby elects to purchase _________ shares of common stock of Bioject Medical Technologies Inc. pursuant to the terms of the attached Warrant, and tenders herewith payment of the purchase price in full, together with all applicable transfer taxes, if any. or (2) In exercising this Warrant, the undersigned hereby confirms and acknowledges that the shares of common stock to be issued upon exercise hereof are being acquired solely for the account of the undersigned and not as a nominee for any other party, and for investment, and that the undersigned will not offer, sell or otherwise dispose of any such shares of common stock except under circumstances that will not result in a violation of the Securities Act of 1933, as amended, or any state securities laws. (3) Please issue a certificate or certificates representing said shares of common stock in the name of the undersigned or in such other name as is specified below: (Name)_______________________________________ (Address)______________________________________ (3) The undersigned represents that (a) he, she or it is the original purchaser from the Corporation of the attached Warrant or an "accredited investor" within the meaning of Rule 501(a) under the Securities Act of 1933, as amended and (b) the aforesaid shares of common stock are being acquired for the account of the undersigned for investment and not with a view to, or for resale in connection with, the distribution thereof and that the undersigned has no present intention of distributing or reselling such shares. (Date)_________________ (Signature)________________________ ASSIGNMENT FORM (To assign the foregoing Warrant, execute this form and supply required information. Do not use this form to purchase shares.) FOR VALUE RECEIVED, the undersigned registered owner of this Warrant hereby sells, assigns and transfers unto the Assignee named below all of the rights of the undersigned under the within Warrant, with respect to the number of shares of common stock of Bioject Medical Technologies Inc. set forth below: Name of Assignee Address No. of Shares _______________ ______________ _________________ and does hereby irrevocably constitute and appoint Attorney ____________ to make such transfer on the books of Bioject Medical Technologies Inc., maintained for the purpose, with full power of substitution in the premises. The undersigned also represents that, by assignment hereof, the Assignee acknowledges that this Warrant and the shares of stock to be issued upon exercise hereof are being acquired for investment and that the Assignee will not offer, sell or otherwise dispose of this Warrant or any shares of stock to be issued upon exercise hereof except under circumstances which will not result in a violation of the Securities Act of 1933, as amended, or any state securities laws. Further, the Assignee shall, if requested by the Corporation, confirm in writing, in a form satisfactory to the Corporation, that the shares of stock so purchased are being acquired for investment and not with a view toward distribution or resale. Dated: ___________________________ Holder's Signature: _______________________ Holder's Address: ___________________________ Guaranteed Signature:________________________ NOTE: The signature to this Assignment Form must correspond with the name as it appears on the face of the Warrant, without alteration or enlargement or any change whatever, and must be guaranteed by a bank or trust company. Officers of corporations and those action in a fiduciary or other representative capacity should file proper evidence of authority to assign the foregoing Warrant. EX-10.37 4 FORM OF SERIES G COMMON STOCK PURCHASE WARRANT. Exhibit 10.37 THIS WARRANT AND THE SECURITIES ISSUABLE UPON EXERCISE HEREOF HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED, OR ANY APPLICABLE STATE LAWS, AND NO INTEREST THEREIN MAY BE SOLD, DISTRIBUTED, ASSIGNED, OFFERED, PLEDGED OR OTHERWISE TRANSFERRED UNLESS THERE IS AN EFFECTIVE REGISTRATION STATEMENT UNDER SUCH ACT AND APPLICABLE STATE SECURITIES LAWS COVERING ANY SUCH TRANSACTION OR SUCH TRANSACTION IS EXEMPT FROM THE REGISTRATION REQUIREMENTS OF SUCH ACT AND LAWS, SUCH COMPLIANCE, AT THE OPTION OF THE CORPORATION, TO BE EVIDENCED BY AN OPINION OF WARRANTHOLDER'S COUNSEL, IN FORM ACCEPTABLE TO THE CORPORATION, THAT NO VIOLATION OF SUCH REGISTRATION PROVISIONS WOULD RESULT FROM ANY PROPOSED TRANSFER OR ASSIGNMENT. SERIES "G" COMMON STOCK PURCHASE WARRANT Bioject Medical Technologies Inc. THIS CERTIFIES that for good and valuable consideration received, _________ a(n)______________or registered assigns, is entitled, upon the terms and subject to the conditions hereinafter set forth, to acquire from Bioject Medical Technologies Inc., an Oregon corporation (the "Corporation") up to __________fully paid and nonassessable shares of common stock, without par value, of the Corporation ("Warrant Stock") at a purchase price per share (the "Exercise Price") of $0.71. 1. Term of Warrant Subject to the terms and conditions set forth herein, this Warrant shall be exercisable, in whole or from time to time part, at any time on or after the date hereof and at or prior to 11:59 p.m., Pacific Standard Time, on June 16, 2002 (the "Expiration Time"). Notwithstanding the foregoing, at any time the Corporation shall have the right, except as may be limited by law, other agreements or herein, to call this Warrant for exercise, in whole or in part, by mailing written notice by United States mail to the registered holder hereof if the average closing bid price for the Corporation's common stock, as quoted by the Nasdaq National Market or any other established over-the-counter quotation service, is equal to or greater than $1.71 per share, as adjusted pursuant to Section 11 hereof, for any consecutive period of twenty trading days. In such event, this Warrant shall expire and cease to be exercisable at 11:59 p.m. Pacific Standard Time, of the twenty-first day after the date of mailing of the notice. 2. Exercise of Warrant The purchase rights represented by this Warrant are exercisable by the registered holder hereof, in whole or in part, at any time and from time to time at or prior to the Expiration Time by the surrender of this Warrant and the Notice of Exercise form attached hereto duly executed to the office of the Corporation at 7620 S.W. Bridgeport Road, Portland, Oregon 97224 (or such other office or agency of the Corporation as it may designate by notice in writing to the registered holder hereof at the address of such holder appearing on the books of the Corporation), and upon payment of the Exercise Price for the shares thereby purchased (by cash or by check or bank draft payable to the order of the Corporation or by cancellation of indebtedness of the Corporation to the holder hereof, if any, at the time of exercise in an amount equal to the purchase price of the shares thereby purchased); whereupon the holder of this Warrant shall be entitled to receive from the Corporation a stock certificate in proper form representing the number of shares of Warrant Stock so purchased. 3. Issuance of Shares; No Fractional Shares of Scrip Certificates for shares purchased hereunder shall be delivered to the holder hereof by the Corporation's transfer agent at the Corporation's expense within a reasonable time after the date on which this Warrant shall have been exercised in accordance with the terms hereof. Each certificate so delivered shall be in such denominations as may be requested by the holder hereof and shall be registered in the name of such holder or, subject to applicable laws, other name as shall be requested by such holder. If, upon exercise of this Warrant, fewer than all of the shares of Warrant Stock evidenced by this Warrant are purchased prior to the Expiration Time, one or more new warrants substantially in the form of, and on the terms in, this Warrant will be issued for the remaining number of shares of Warrant Stock not purchased upon exercise of this Warrant. The Corporation hereby represents and warrants that all shares of Warrant Stock which may be issued upon the exercise of this Warrant will, upon such exercise, be duly and validly authorized and issued, fully paid and nonassessable and free from all taxes, liens and charges in respect of the issuance thereof (other than liens or charges created by or imposed upon the holder of the Warrant Stock). The Corporation agrees that the shares so issued shall be and be deemed to be issued to such holder as the record owner of such shares as of the close of business on the date on which this Warrant shall have been surrendered for exercise in accordance with the terms hereof. No fractional shares or scrip representing fractional shares shall be issued upon the exercise of this Warrant. With respect to any fraction of a share called for upon the exercise of this Warrant, an amount equal to such fraction multiplied by the then current price at which each share may be purchased hereunder shall be paid in cash to the holder of this Warrant. 4. Charges, Taxes and Expenses Issuance of certificates for shares of Warrant Stock upon the exercise of this Warrant shall be made without charge to the holder hereof for any issue or transfer tax or other incidental expense in respect of the issuance of such certificate, all of which taxes and expenses shall be paid by the Corporation, and such certificates shall be issued in the name of the holder of this Warrant or in such name or names as may be directed by the holder of this Warrant; provided, however, that in the event certificates for shares of Warrant Stock are to be issued in a name other than the name of the holder of this Warrant, this Warrant when surrendered for exercise shall be accompanied by the Assignment Form attached hereto duly executed by the holder hereof. 5. No Rights as Shareholders This Warrant does not entitle the holder hereof to any voting rights or other rights as a shareholder of the Corporation prior to the exercise hereof. 6. Registration Rights This Warrant is a Series "G" Warrant identified in the Registration Rights Agreement dated as of June, 1997 between the Corporation and the parties listed on the signature pages thereto. A transferee of this Warrant may become a "Holder" as defined in such agreement upon compliance with the requirements of such agreement. 7. Exchange and Registry of Warrant This Warrant is exchangeable, upon the surrender hereof by the registered holder at the above-mentioned office or agency of the Corporation, for a new Warrant of like tenor and dated as of such exchange. The Corporation shall maintain at the above-mentioned office or agency a registry showing the name and address of the registered holder of this Warrant. This Warrant may be surrendered for exchange, transfer or exercise, in accordance with its terms, at such office or agency of the Corporation, and the Corporation shall be entitled to rely in all respects, prior to written notice to the contrary, upon such registry. 8. Loss, Theft, Destruction or Mutilation of Warrant Upon receipt by the Corporation of evidence reasonably satisfactory to it of the loss, theft, destruction or mutilation of this Warrant, and in case of loss, theft or destruction of indemnity or security reasonably satisfactory to it, and upon reimbursement to the Corporation of all reasonable expenses incidental thereto, and upon surrender and cancellation of this Warrant, if mutilated, the Corporation will make and deliver a new Warrant of like tenor and dated as of such cancellation, in lieu of this Warrant. 9. Saturdays, Sundays and Holidays If the last or appointed day for the taking of any action or the expiration of any right required or granted herein shall be a Saturday or a Sunday or shall be a legal holiday, then such action may be taken or such right may be exercised on the next succeeding day not a Saturday, Sunday or legal holiday. 10. Merger, Sale of Assets, Etc. If at any time the Corporation proposes to merge or consolidate with or into any other corporation, effect any reorganization, or sell or convey all or substantially all of its assets to any other entity, then, as a condition of such reorganization, consolidation, merger, sale or conveyance, the Corporation or its successor, as the case may be, shall enter into a supplemental agreement to make lawful and adequate provision whereby the holder shall have the right to receive, upon exercise of the Warrant, the kind and amount of equity securities which would have been received upon such reorganization, consolidation, merger, sale or conveyance by a holder of a number of shares of common stock equal to the number of shares issuable upon exercise of the Warrant immediately prior to such reorganization, consolidation, merger, sale or conveyance. If the property to be received upon such reorganization, consolidation, merger, sale or conveyance is not equity securities, the Corporation shall give the holder of this Warrant ten (10) business days prior written notice of the proposed effective date of such transaction, and if this Warrant has not been exercised by or on the effective date of such transaction, it shall terminate. 11. Subdivision, Combination, Reclassification, Conversion, Etc. If the Corporation at any time shall, by subdivision, combination, reclassification of securities or otherwise, change the Warrant Stock into the same or a different number of securities of any class or classes, this Warrant shall thereafter entitle the holder to acquire such number and kind of securities as would have been issuable in respect of the Warrant Stock (or other securities which were subject to the purchase rights under this Warrant immediately prior to such subdivision, combination, reclassification or other change) as the result of such change if this Warrant had been exercised in full for cash immediately prior to such change. The Exercise Price hereunder shall be adjusted if and to the extent necessary to reflect such change. If the Warrant Stock or other securities issuable upon exercise hereof are subdivided or combined into a greater or smaller number of shares of such security, the number of shares issuable hereunder shall be proportionately increased or decreased, as the case may be, and the Exercise Price shall be proportionately reduced or increased, as the case may be, in both cases according to the ratio which the total number of shares of such security to be outstanding immediately after such even bears to the total number of shares of such security outstanding immediately prior to such event. The Corporation shall give the holder prompt written notice of any change in the type of securities issuable hereunder, any adjustment of the Exercise Price for the securities issuable hereunder, and any increase or decrease in the number of shares issuable hereunder. 12. Transferability; Compliance with Securities Laws (a) This Warrant may not be transferred or assigned in whole or in part without compliance with all applicable federal and state securities laws by the transferor and transferee (including the delivery of investment representation letters and legal opinions reasonably satisfactory to the Corporation, if requested by the Corporation). Subject such restrictions, prior to the Expiration Time, this Warrant and all rights hereunder are transferable by the holder hereof, in whole or in part, at the office or agency of the Corporation referred to in Section 1 hereof. Any such transfer shall be made in person or by the holder's duly authorized attorney, upon surrender of this Warrant together with the Assignment Form attached hereto properly endorsed. (b) The Holder of this Warrant, by acceptance hereof, acknowledges that this Warrant and the Warrant Stock issuable upon exercise hereof are being acquired solely for the holder's own account and not as a nominee for any other party, and for investment, and that the holder will not offer, sell or otherwise dispose of this Warrant or any shares of Warrant Stock to be issued upon exercise hereof except under circumstances that will not result in a violation of the Securities Act of 1933, as amended, or any state securities laws. Upon exercise of this Warrant, the holder shall, if requested by the Corporation, confirm in writing, in a form satisfactory to the Corporation, that the shares of Warrant Stock so purchased are being acquired solely for holder's own account and not as a nominee for any other party, for investment, and not with a view toward distribution or resale. (c) The Warrant Stock has not been and will not be registered under the Securities Act of 1933, as amended, and this Warrant may not be exercised except by (i) the original purchaser of this Warrant from the Corporation or (ii) an "accredited investor" as defined in Rule 501(a) under the Securities Act of 1933, as amended. Each certificate representing the Warrant Stock or other securities issued in respect of the Warrant Stock upon any stock split, stock dividend, recapitalization, merger, consolidation or similar event, shall be stamped or otherwise imprinted with a legend substantially in the following form (in addition to any legend required under applicable securities laws): THE SECURITIES REPRESENTED HEREBY HAVE NOT BEEN REGISTERED UNDER UNITED STATES FEDERAL OR STATE SECURITIES LAWS AND MAY NOT BE OFFERED FOR SALE, SOLD OR OTHERWISE TRANSFERRED OR ASSIGNED FOR VALUE, DIRECTLY OR INDIRECTLY, NOR MAY THE SECURITIES BE TRANSFERRED ON THE BOOKS OF THE CORPORATION, WITHOUT REGISTRATION OF SUCH SECURITIES UNDER ALL APPLICABLE UNITED STATES FEDERAL OR STATE SECURITIES LAWS OR COMPLIANCE WITH AN APPLICABLE EXEMPTION THEREFROM, SUCH COMPLIANCE, AT THE OPTION OF THE CORPORATION, TO BE EVIDENCED BY AN OPINION OF SHAREHOLDER'S COUNSEL, IN FORM ACCEPTABLE TO THE CORPORATION, THAT NO VIOLATION OF SUCH REGISTRATION PROVISIONS WOULD RESULT FROM ANY PROPOSED TRANSFER OR ASSIGNMENT. 13. Representations and Warranties The Corporation hereby represents and warrants to the holder hereof that: (a) during the period this Warrant is outstanding, the Corporation will reserve from its authorized and unissued common stock a sufficient number of shares to provide for the issuance of Warrant Stock upon the exercise of this Warrant; (b) the issuance of this Warrant shall constitute full authority to the Corporation's officers who are charged with the duty of executing stock certificates to execute and issue the necessary certificates for the shares of Warrant Stock issuable upon exercise of this Warrant; (c) the Corporation has all requisite legal and corporate power to execute and deliver this Warrant, to sell and issue the Warrant Stock hereunder, to issue the common stock issuable upon exercise of the Warrant Stock and to carry out and perform its obligations under the terms of this Warrant; (d) all corporate action on the part of the Corporation, its directors and shareholders necessary for the authorization, execution, delivery and performance of this Warrant by the Corporation, the authorization, sale, issuance and delivery of the Warrant Stock, the grant of registration rights as provided herein and the performance of the Corporation's obligations hereunder has been taken; (e) the Warrant Stock, when issued in compliance with the provisions of this Warrant and the Corporation's Articles of Incorporation (as they may be amended from time to time (the "Articles")), will be validly issued, fully paid and nonassessable, and free of all taxes, liens or encumbrances with respect to the issue thereof, and will be issued in compliance with all applicable federal and state securities laws; and (f) the issuance of the Warrant Stock will not be subject to any preemptive rights, rights of first refusal or similar rights. 14. Corporation The Corporation will not, by amendment of its Articles or through any reorganization, recapitalization, transfer of assets, consolidation, merger, dissolution, issue or sale of securities or any other action, avoid or seek to avoid the observance or performance of any of the terms to be observed or performed hereunder by the Corporation, but will at all times in good faith assist in the carrying out of all the provisions of this Warrant and in the taking of all such action as may be necessary or appropriate in order to protect the rights of the holder of the Warrant against impairment. 15. Governing Law This Warrant shall be governed by and construed in accordance with the laws of the State of Oregon. IN WITNESS WHEREOF, the Corporation has caused this Warrant to be executed by its duly authorized officers. Dated: ___________ , 1997 BIOJECT MEDICAL TECHNOLOGIES INC. By:____________________________________ Name: Peggy J. Miller Title: Vice President, Chief Financial Officer & Secretary NOTICE OF EXERCISE To: Bioject Medical Technologies Inc. (1) [Please check one] ___The undersigned hereby elects to purchase ____shares of common stock of Bioject Medical Technologies Inc. pursuant to the terms of the attached Warrant, and tenders herewith payment of the purchase price in full, together with all applicable transfer taxes, if any. or ___ The undersigned hereby irrevocably commits to purchase ___ shares of common stock of Bioject Medical Technologies Inc. pursuant to the terms of the attached Warrant, and commits to tender payment of the purchase price in full, together with all applicable transfer taxes, if any, subject only to the conditions that (i) a Form S-3 registration statement pursuant to which the shares of common stock will be registered for resale is filed and becomes effective and (ii) the average of the bid and asked prices for shares of the common stock as quoted by the Nasdaq National Market for the day before the date of effectiveness is greater than $1.71. (2) In exercising this Warrant, the undersigned hereby confirms and acknowledges that the shares of common stock to be issued upon exercise hereof are being acquired solely for the account of the undersigned and not as a nominee for any other party, and for investment, and that the undersigned will not offer, sell or otherwise dispose of any such shares of common stock except under circumstances that will not result in a violation of the Securities Act of 1933, as amended, or any state securities laws. (3) Please issue a certificate or certificates representing said shares of common stock in the name of the undersigned or in such other name as is specified below: (Name)___________________________________________ (Address)__________________________________________ (3) The undersigned represents that (a) he, she or it is the original purchaser from the Corporation of the attached Warrant or an "accredited investor" within the meaning of Rule 501(a) under the Securities Act of 1933, as amended and (b) the aforesaid shares of common stock are being acquired for the account of the undersigned for investment and not with a view to, or for resale in connection with, the distribution thereof and that the undersigned has no present intention of distributing or reselling such shares. (Date)_________________________(Signature)__________________________ ASSIGNMENT FORM (To assign the foregoing Warrant, execute this form and supply required information. Do not use this form to purchase shares.) FOR VALUE RECEIVED, the undersigned registered owner of this Warrant hereby sells, assigns and transfers unto the Assignee named below all of the rights of the undersigned under the within Warrant, with respect to the number of shares of common stock of Bioject Medical Technologies Inc. set forth below: Name of Assignee Address No. of Shares _________________ _____________ _______________ and does hereby irrevocably constitute and appoint Attorney ____________ to make such transfer on the books of Bioject Medical Technologies Inc., maintained for the purpose, with full power of substitution in the premises. The undersigned also represents that, by assignment hereof, the Assignee acknowledges that this Warrant and the shares of stock to be issued upon exercise hereof are being acquired for investment and that the Assignee will not offer, sell or otherwise dispose of this Warrant or any shares of stock to be issued upon exercise hereof except under circumstances which will not result in a violation of the Securities Act of 1933, as amended, or any state securities laws. Further, the Assignee shall, if requested by the Corporation, confirm in writing, in a form satisfactory to the Corporation, that the shares of stock so purchased are being acquired for investment and not with a view toward distribution or resale. Dated:_____________________________ Holder's Signature:___________________________ Holder's Address: ____________________________ Guaranteed Signature:_________________________ NOTE: The signature to this Assignment Form must correspond with the name as it appears on the face of the Warrant, without alteration or enlargement or any change whatever, and must be guaranteed by a bank or trust company. Officers of corporations and those action in a fiduciary or other representative capacity should file proper evidence of authority to assign the foregoing Warrant. EX-10.38 5 REGISTRATION RIGHTS AGREEMENT Exhibit 10.38 REGISTRATION RIGHTS AGREEMENT This Agreement is made as of June ___ , 1997 by and among BIOJECT MEDICAL TECHNOLOGIES INC., an Oregon corporation (the "Corporation"), and the investors listed on Schedule A hereto (the "Investors"). RECITALS A. Simultaneously herewith, the Corporation is selling to the Investors and the Investors are purchasing from the Corporation an aggregate of _________ shares of the Corporation's Common Stock and warrants to purchase up to an aggregate of _____ shares of the Corporation's Common Stock (the "Warrants") pursuant to the Stock Subscription Agreement dated June___ , 1997 (the "Subscription Agreement"). B. It is a condition precedent to the Subscription Agreement that the parties enter into this Agreement. AGREEMENT NOW, THEREFORE, it is hereby agreed as follows: 1. Certain Definitions As used in this Agreement, the following terms shall have the following respective meanings: "Binding Commitment" shall mean an executed Notice of Exercise of a Warrant by a Holder constituting an irrevocable and binding commitment to purchase the common stock issuable upon exercise of the Warrant, subject only to the conditions that (i) a Form S-3 registration statement pursuant to which the Warrant Shares will be registered for resale is filed and becomes effective and (ii) the average of the bid and asked prices for shares of the Corporation's common stock as quoted by the Nasdaq National Market for the day before the date of effectiveness is greater than $0.71. "Common Stock" shall mean shares of common stock, without par value, of the Corporation. "Commission" shall mean the Securities and Exchange Commission. "Holder" shall mean the holders of Registrable Securities and any person holding such securities to whom the rights under this Agreement have been transferred in accordance with Section 2.8 hereof. "Initiating Holders" shall mean any Holder or Holders of the Registrable Securities initiating a registration request pursuant to Sections 2.2(b) and 2.2(c). "Registrable Securities" means (i) all shares of the Corporation's Common Stock acquired pursuant to the Subscription Agreement ("Subscription Shares"), or acquired upon exercise of the Series "G" Warrants ("Warrant Shares")(collectively, the "Shares"), (ii) any Common Stock or other securities of the Corporation issued or issuable with respect to, or in exchange for or in replacement of the Shares or such additional shares upon any stock split, stock dividend, recapitalization, or similar event; provided, however, that shares of Common Stock or other securities shall only be treated as Registrable Securities for the purposes of Section 2 hereof if and so long as they have not been sold pursuant to Rule 144 under the Securities Act or pursuant to an effective Registration Statement under the Securities Act, or otherwise to or through a broker or dealer or underwriter in a public distribution or a public securities transaction. The terms "register," "registered" and "registration" refer to a registration effected by preparing and filing a registration statement in compliance with the Securities Act, and the declaration or ordering of the effectiveness of such registration statement. "Registration Expenses" shall mean all expenses, except as otherwise stated below, incurred by the Corporation in complying with Section 2 hereof, including, without limitation, all registration, qualification and filing fees, printing expenses, escrow fees, fees and disbursements of counsel for the Corporation and one special counsel to the selling Holders, blue sky fees and expenses, fees to Nasdaq to list the Shares or American Stock Transfer and Trust Company to issue the Shares, and the expense of any special audits incident to or required by any such registration. "Securities Act" shall mean the Securities Act of 1933, as amended, or any similar federal statute and the rules and regulations of the Commission thereunder, all as the same shall be in effect at the time. "Selling Expenses" shall mean all underwriting discounts, selling commissions and stock transfer taxes applicable to the securities registered by the selling Holders and any other expenses that are not Registration Expenses and that are incurred by the selling Holders. "Subscription Shares" are defined under "Registrable Securities." "Warrant Shares" are defined under "Registrable Securities." 2. Registration Rights 2.1 Company Registration a) Notice of Registration. If at any time or from time to time the Corporation shall determine to register any of its securities, either for its own account or the account of a security holder or holders, other than a registration relating solely to employee benefit plans or a registration relating solely to a Commission Rule 145 transaction, the Corporation will: (i) promptly give to each Holder written notice thereof; and (ii) subject to Section 2.1(b), include in such registration (and any related qualification under blue sky laws or other compliance), and in any underwriting involved therein, all the Registrable Securities specified in a written request or requests made within 20 days after receipt of such written notice from the Corporation, by any Holder. (b) Underwriting. If the registration of which the Corporation gives notice is for a registered public offering involving an underwriting, the Corporation shall so advise the Holders as a part of the written notice given pursuant to Section 2.1(a) hereof. In such event the right of any Holder to registration pursuant to this Section 2.1 shall be conditioned upon such Holder's participation in such underwriting and the inclusion of Registrable Securities in the underwriting to the extent provided herein. All Holders proposing to distribute their securities through such underwriting shall (together with the Corporation) enter into an underwriting agreement in customary form with the managing underwriter selected for such underwriting by the Corporation. Notwithstanding any other provision of this Section 2.1, if the managing underwriter determines that marketing factors require a limitation of the number of shares to be underwritten, the managing underwriter may limit the Registrable Securities and other securities to be distributed through such underwriting, for the account of the requesting Holders to 20% of the total number of shares to be distributed. The Corporation shall so advise all Holders distributing their securities through such underwriting of such limitations and, subject to the foregoing rights of the Investors, the number of shares of Registrable Securities, if any, that may be included in the registration (and underwriting, if any) shall be allocated among all Holders in proportion, as nearly as practicable, to the respective amounts of Registrable Securities requested by such Holders to be included in such Registration Statement. To facilitate the allocation of shares in accordance with the above provisions, the Corporation may round the number of shares allocated to any Holder or holder to the nearest 100 shares. (c) Right to Terminate Registration. The Corporation shall have the right to terminate or withdraw any registration initiated by it under this Section 2.1 prior to the effectiveness of such registration whether or not any Holder has elected to include securities in such registration. The Registration Expenses of such withdrawn registration shall be borne by the Corporation in accordance with Section 2.3 hereof. 2.2 Demand Registration (a) The Corporation shall use its best efforts to file within thirty (30) days of the date of this Agreement a registration statement on Form S-3 for the resale of the Subscription Shares and shall use its best efforts to cause such registration statement to become effective as expeditiously as reasonably practical. The Corporation shall be obligated to prepare, file and cause to be effective only one registration statement pursuant to this Section 2.2(a). Further, the Corporation shall use all reasonable efforts to cause such registration to be a non-underwritten shelf registration pursuant to Rule 415 under the Securities Act and to cause such shelf registration to be maintained effective for at least two (2) years. (b) Any Initiating Holder or Holders of an aggregate of at least a majority of the Warrant Shares for which Binding Commitments have been received by the Corporation, may request registration of such Holder(s)' Warrant Shares when Binding Commitments to exercise _____ Warrants (representing approximately 51% of the original number of Warrants) have been received by the Corporation. Upon receipt of such request (specifying that it is being made pursuant to this Section 2.2(b)), the Corporation shall promptly prepare and file a registration statement on Form S-3 under the Securities Act covering the Warrant Shares that are the subject of such request and shall use its best efforts to cause such registration statement to become effective as expeditiously as reasonably practical. The Corporation shall be obligated to prepare, file and cause to be effective only one registration statement pursuant to this Section 2.2(b). Upon the receipt of such request, the Corporation shall: (i) promptly give to each remaining Holder written notice that a registration is to be effected; and (ii) include in such registration (and any related qualification under blue sky laws or other compliance) all the Warrant Shares specified in a written request or requests made within 10 days after such written notice was sent by the Corporation, by any Holder. However, no Warrant Shares shall be included in such registration if a Binding Commitment has not been received by the Corporation for such Warrant Shares. Further, the Corporation shall use all reasonable efforts to cause such registration to be a non-underwritten shelf registration pursuant to Rule 415 under the Securities Act and to cause such shelf registration to be maintained effective for at least two (2) years. (c) Any Initiating Holder or Holders of an aggregate of at least a majority of the Warrant Shares, may request registration of such Holder(s)' Warrant Shares when the Corporation has called the Warrants for exercise, in whole or in part, in accordance with Section 1 of the Series "G" Warrants. Upon receipt of such request (specifying that it is being made pursuant to this Section 2.2(c)), the Corporation shall promptly prepare and file a registration statement on Form S-3 under the Securities Act covering the Warrant Shares that are the subject of such request and shall use its best efforts to cause such registration statement to become effective as expeditiously as reasonably practical. Upon the receipt of such request, the Corporation shall: (i) promptly give to each remaining Holder written notice that a registration is to be effected; and (ii) include in such registration (and any related qualification under blue sky laws or other compliance) all the Warrant Shares specified in a written request or requests made within 10 days after such written notice was sent by the Corporation, by any Holder. Further, the Corporation shall use all reasonable efforts to cause such registration to be a non-underwritten shelf registration pursuant to Rule 415 under the Securities Act and to cause such shelf registration to be maintained effective for at least two (2) years. (d) Notwithstanding the foregoing, the Corporation shall not be obligated to take any action pursuant to this Section 2.2: (i) in any particular jurisdiction in which the Corporation would be required to execute a general consent to service of process in effecting such registration, qualification or compliance unless the Corporation is already subject to service in such jurisdiction and except as may be required by the Securities Act; or (ii) if the Corporation shall furnish to the Holders a certificate signed by the Chairman or President of the Corporation stating that the Corporation has reasonably determined that it should postpone for a specified period of time not to exceed 120 days in the case of clause (A) below, or 45 days in the case of clause (B) below (each, a "Blackout Period"), any action pursuant to this Section, including, without limitation, the preparation and/or filing of a registration statement or prospectus or any amendments or supplements to any registration statement or prospectus, because any such filing would (A) materially impede, delay or otherwise interfere with an offer or sale of securities, acquisition, corporate reorganization or other significant transaction involving the Corporation, or (B) require disclosure of material information (other than an event described in clause (A) above) which, if disclosed at that time, would be materially harmful to the interests of the Corporation and its shareholders. Upon delivery of such a certificate to the Holders by the Corporation, each of the Holders covenants that he shall (X) keep the fact of the notice strictly confidential, (Y) promptly halt any offer, sale, trading or transfer by him and his affiliates of any Common Stock for the duration of the Blackout Period set forth in the certificate or until the Blackout Period is earlier terminated by the Corporation and (Z) promptly halt any use or distribution of the registration statement and prospectus by him and his affiliates for the duration of the Blackout Period or until such Blackout Period is earlier terminated by the Corporation. The Corporation shall not be entitled to deliver a certificate and impose a Blackout Period pursuant to Clause A more than once in any twelve month period. 2.3 Expenses of Registration All Registration Expenses incurred in connection with registration pursuant to Sections 2.1 and 2.2 shall be borne by the Corporation. All Selling Expenses relating to securities registered on behalf of the Holders shall be borne by the Holders of securities included in such registration pro rata, severally and not jointly, among each other on the basis of the number of shares so registered. 2.4 Registration Procedures In the case of each registration effected by the Corporation pursuant to this Section 2, the Corporation will keep each Holder advised in writing as to the initiation of each registration and as to the completion thereof. At its expense the Corporation will: (a) Prepare and file with the Commission a registration statement with respect to such securities and use its best efforts to cause such registration statement to become and remain effective for at least two (2) years or, if earlier, until the distribution described in the registration statement has been completed; (b) Prepare and file with the Commission during the period specified in Section 2.4(a) such amendments and supplements to such registration statement and the prospectus used in connection with such registration statement as may be necessary to comply with the provisions of the Securities Act with respect to the disposition of all securities covered by such registration statement; (c) Furnish to the Holders participating in such registration and to the underwriters of the securities being registered such reasonable number of copies of the registration statement, preliminary prospectus, final prospectus and such other documents as the Holders and such underwriters may reasonably request in order to facilitate the public offering of such securities; (d) Furnish, at the request of any Holder requesting registration of Registrable Securities at the time such securities are delivered to the underwriters (if any) for sale in connection with a registration pursuant to this Section 2, (i) an opinion, dated such date, of the counsel representing the Corporation for the purposes of such registration, in form and substance as is customarily given to underwriters in an underwritten public offering, addressed to the underwriters and to the Holders requesting registration of Registrable Securities and (ii) a letter dated the date of commencement of the offering and a "bring-down" letter dated as of the closing date of such offering, from the independent accountants of the Corporation, in form and substance as is customarily given by independent accountants to underwriters in an underwritten public offering, addressed to the underwriters, if any, and to the Holders requesting registration of Registrable Securities. 2.5 Indemnification (a) The Corporation will indemnify each Holder and each person controlling such Holder within the meaning of Section 15 of the Securities Act, with respect to which registration has been effected pursuant to this Section 2, and each underwriter, if any, and each person who controls any underwriter within the meaning of Section 15 of the Securities Act, against all expenses, claims, losses, damages or liabilities (or actions in respect thereof), including any of the foregoing incurred in settlement of any litigation, commenced or threatened, arising out of or based on any untrue statement (or alleged untrue statement) of a material fact contained in any registration statement, prospectus, offering circular or other document, or any amendment or supplement thereto, incident to any such registration, qualification or compliance, or based on any omission (or alleged omission) to state therein a material fact required to be stated therein or necessary to make the statements therein, in light of the circumstances in which they were made, not misleading, or any violation by the Corporation of the Securities Act or any other applicable federal and state securities laws or any rules or regulations promulgated thereunder in connection with any such registration, qualification or compliance, and the Corporation will reimburse each such Holder, each of its officers, directors, partners, and legal counsel and each person controlling such Holder, each such underwriter and each person who controls any such underwriter, for any legal and any other expenses reasonably incurred in connection with investigating, preparing or defending any such claim, loss, damage, liability or action, provided that the Corporation will not be liable in any such case to the extent that any such claim, loss, damage, liability or expense arises out of or is based on any untrue statement or omission or alleged untrue statement or omission, made in reliance upon and in conformity with written information furnished to the Corporation by such Holder, controlling person or underwriter and stated to be specifically for use therein. (b) Each Holder will, if Registrable Securities held by such Holder are included in the securities as to which such registration, qualification or compliance is being effected, indemnify the Corporation, each of its directors and officers, each underwriter, if any, of the Corporation's securities covered by such a registration statement, each person who controls the Corporation or such underwriter within the meaning of Section 15 of the Securities Act, and each other Holder, each of its officers and directors, and each person controlling such Holder within the meaning of Section 15 of the Securities Act, against all claims, losses, damages and liabilities (or actions in respect thereof) arising out of or based on any untrue statement (or alleged untrue statement) of a material fact contained in any such registration statement, prospectus, offering circular or other document, or any omission (or alleged omission) to state therein a material fact required to be stated therein or necessary to make the statements therein not misleading, and will reimburse the Corporation, such Holders, and such directors, officers, underwriters or control persons for any legal or any other expenses reasonably incurred in connection with investigating or defending any such claim, loss, damage, liability or action, in each case to the extent, but only to the extent, that such untrue statement (or alleged untrue statement) or omission (or alleged omission) is made in such registration statement, prospectus, offering circular or other document in reliance upon and in conformity with written information furnished to the Corporation by such Holder and stated to be specifically for use therein Notwithstanding the foregoing, the liability of each Holder under this subsection (b) shall be limited to the proportion of any such loss, claim, damage, liability or expense which is equal to the proportion that the public offering price of the shares sold by such Holder under such registration statement bears to the total public offering price of all securities sold thereunder, but not to exceed the proceeds received by such Holder from the sale of Registrable Securities covered by such registration statement. (c) Each party entitled to indemnification under this Section 2.5 (the "Indemnified Party") shall give notice to the party required to provide indemnification (the "Indemnifying Party") promptly after such Indemnified Party has actual knowledge of any claim as to which indemnity may be sought, and shall permit the Indemnifying Party to assume the defense of any such claim or any litigation resulting therefrom, provided that counsel for the Indemnifying Party, who shall conduct the defense of such claim or litigation resulting therefrom, shall be approved by the Indemnified Party (whose approval shall not unreasonably be withheld), and the Indemnified Party may participate in such defense at such party's expense, and provided further that the failure of any Indemnified Party to give notice as provided herein shall not relieve the Indemnifying Party of its obligations under this Section 2 unless the failure to give such notice is materially prejudicial to an Indemnifying Party's ability to defend such action and provided further, that the Indemnifying Party shall not assume the defense for matters as to which there is a conflict of interest or separate and different defenses but shall bear the expense of such defense nevertheless. Each Indemnified Party shall furnish such information regarding itself or the claim in question as an Indemnifying Party may reasonably request in writing and as shall be reasonably required in connection with the defense of such claim and litigation resulting therefrom. No Indemnifying Party, in the defense of any such claim or litigation, shall, except with the consent of each Indemnified Party, consent to entry of any judgment or enter into any settlement which does not include as an unconditional term thereof the giving by the claimant or plaintiff to such Indemnified Party of a release from all liability in respect to such claim or litigation. Notwithstanding the other provisions of this Agreement, no Indemnifying Party shall be obligated to indemnify any Indemnified Party for amounts paid by the Indemnified Party in settlement of any loss, claim, damage, liability or action if such settlement is effected without the consent of the Indemnifying Party (which consent has not been unreasonably withheld). (d) If the indemnification provided for paragraphs (a) through (c) of this Section 2.5 is unavailable or insufficient to hold harmless an Indemnified Party under such paragraphs in respect of any losses, claims, damages, liabilities, expenses or actions in respect thereof referred to therein, then each Indemnifying Party shall in lieu of indemnifying such Indemnified Party contribute to the amount paid or payable by such Indemnified Party as a result of such losses, claims, damages, liabilities or actions in such proportion as appropriate to reflect the relative fault of the Corporation, the underwriters, and the Holder of such Registrable Securities, respectively, in connection with the statements or omissions which resulted in such losses, claims, damage, liabilities, expenses or actions in respect thereof as well as any other relevant equitable considerations, including the failure to give any notice under paragraph (c). The relative fault shall be determined by reference to, among other things, whether the untrue or alleged untrue statement of a material fact relates to information supplied by the Corporation, on the one hand, or the underwriters or the Holders of such Registrable Securities, on the other, and to the parties' relative intent, knowledge, access to information and opportunity to correct or prevent such statement or omission. The Corporation and each of the Holders agrees that it would not be just and equitable if contributions pursuant to this paragraph were determined by pro rata allocation (even if all of the Holders of such Registrable Securities were treated as one entity for such purpose) or by any other method of allocation which did not take account of the equitable considerations referred to above in this paragraph. The amount paid or payable by an indemnified party as a result of the losses, claims, damages, liabilities or action in respect thereof, referred to above in this paragraph, shall be deemed to include any legal or other expenses reasonably incurred by such indemnified party in connection with investigating or defending any such action or claim. Notwithstanding the provisions of this paragraph, no Holder shall be required to contribute any amount in excess of the lesser of (i) the proportion that the public offering price of shares sold by such Holder under such registration statement bears to the total public offering price of all securities sold thereunder, but not to exceed the proceeds received by such Holder for the sale of Registrable Securities covered by such registration statement and (ii) the amount of any damages which they would have otherwise been required to pay by reason of such untrue or alleged untrue statement or omission. No person guilty of fraudulent misrepresentations (within the meaning of Section 11(f) of the Securities Act), shall be entitled to contribution from any person who is not guilty of such fraudulent misrepresentation (e) Notwithstanding the foregoing, to the extent that the provisions on indemnification and contribution contained in the underwriting agreement (if any) entered into in connection with an underwritten public offering of the Registrable Securities are in conflict with the foregoing provisions, the provisions in such underwriting agreement shall control. 2.6 Information by Holder The Holder or Holders of Registrable Securities included in any registration shall furnish to the Corporation such information regarding such Holder or Holders, the Registrable Securities held by them and the distribution proposed by such Holder or Holders as the Corporation may reasonably request in writing and as shall be required in connection with any registration, qualification or compliance referred to in this Section 2. 2.7 Rule 144 Reporting With a view to making available the benefits of certain rules and regulations of the Commission which may at any time permit the sale of the Registrable Securities to the public without registration, the Corporation agrees to use its best efforts to: (a) At all times make and keep public information available, as those terms are understood and defined in Rule 144 under the Securities Act; (b) File with the Commission in a timely manner all reports and other documents required of the Corporation under the Securities Act and the Securities Exchange Act of 1934, as amended; (c) So long as a Holder owns any Registrable Securities to furnish to the Holder forthwith upon request a written statement by the Corporation as to its compliance with the reporting requirements of said Rule 144, and of the Securities Act and the Securities Exchange Act of 1934, a copy of the most recent annual or quarterly report of the Corporation, and such other reports and documents of the Corporation and other information in the possession of or reasonably obtainable by the Corporation as a Holder may reasonably request in availing itself of any rule or regulation of the Commission allowing a Holder to sell any such securities without registration. 2.8 Transfer of Registration Rights The rights to cause the Corporation to register securities granted Holders under this Section 2 may be assigned (a) to a transferee or assignee in connection with any transfer or assignment of Registrable Securities by a Holder of not less than 25,000 shares of Registrable Securities (as presently constituted and subject to subsequent adjustments for stock splits, stock dividends, reverse stock splits, and the like), or (b) to the estate of a Holder, provided in each case that such transfer may otherwise be effected in accordance with applicable securities laws and written notice of the transfer is given to the Corporation at the time of or within a reasonable time after such transfer or assignment, stating the name and address of the transferee or assignee and identifying the Registrable Securities with respect to which such registration rights are being transferred or assigned, and provided, further, that the transferee or assignee of such rights agrees in writing to be bound by the terms of this Agreement as if such transferee were a party hereto. 2.9 Standoff Agreement Each Holder agrees, in connection with registered public offerings of the Corporation's securities for the account of the Corporation, upon request of the Corporation or the underwriters managing any underwritten offering of the Corporation's securities, not to sell, make any short sale of or otherwise dispose of any Registrable Securities (other than those included in the registration) without the prior written consent of the Corporation or such underwriters, as the case may be, for such period of time (not to exceed 120 days in the case of other public offerings) from the effective date of such registration as may be requested by the underwriters, provided, that the officers and directors of the Corporation who own stock of the Corporation also agree to such restrictions. 2.10 Termination of Registration Rights The rights granted under this Section 2 shall terminate on the earlier of June ___, 2002 or such time as the aggregate number of Registrable Securities held by all Holders represents less than one percent of the outstanding shares of the Corporation's Common Stock. 2.11 Delay of Registration No Holder or Holders shall have any right to take any action to restrain, enjoin, or otherwise delay any registration as a result of any controversy that might arise with respect to the interpretation or implementation of this Section 2. 2.12 Use of Form S-3 With a view to maintaining its eligibility to use Form S-3, the Corporation agrees to use its best efforts to file with the Commission in a timely manner (i) all the material required to be filed pursuant to Sections 13, 14 or 15(d) of the Securities Exchange Act of 1934, as amended, and (ii) all reports and other documents required to be filed by the Corporation under the Securities Act and the Securities Exchange Act of 1934, as amended; provided, however, that there can be no assurance that the Corporation will remain eligible for use of Form S-3 or that any Form S-3 filed by the Corporation with respect to the Registrable Securities will be declared effective. 3. Miscellaneous 3.1 Waivers and Amendments With the written consent of both the Corporation and Holders of a majority of outstanding Registrable Securities originally acquired by the Investors then held by Holders (voting together as a class), the obligations of the Corporation and the rights of such Holders of Registrable Securities under this Agreement may be waived (either generally or in a particular instance, and either for a specified period of time or indefinitely), and with the same consent the Corporation, when authorized by resolution of its Board of Directors, may enter into a supplementary agreement for the purpose of adding any provisions to or changing in any manner or eliminating any of the provisions of this Agreement. Neither this Agreement nor any provisions hereof may be changed, waived, discharged or terminated orally, but only by a signed statement in writing. 3.2 Governing Law This Agreement shall be governed in all respects by the laws of the State of Oregon as such laws are applied to agreements between Oregon residents entered into and to be performed entirely within Oregon. 3.3 Successors and Assigns Except as otherwise expressly provided herein, the Provisions hereof shall inure to the benefit of, and be binding upon, the successors, assigns, heirs, executors and administrators of the parties hereto. 3.4 Entire Agreement This Agreement constitutes the full and entire understanding and agreement between the parties with regard to the subjects hereof. 3.5 Notices All notices and other communications required or permitted hereunder shall be effective upon receipt and shall be in writing and may be delivered in person, by telecopy, electronic mail, overnight delivery service or U.S. mail, in which event it may be mailed by first class, postage prepaid, addressed (a) if to one of the Investors, at the address set forth on the signature page(s) to the Subscription Agreement, or at such other address as the Holder shall have furnished to the Corporation, or (b) if to the Corporation, at 7620 SW Bridgeport Road, Portland, Oregon 97224, Attention: President, or at such other address as shall have furnished to the Holders in writing. Notwithstanding the foregoing, all notices and communications to addresses outside the United States shall be given by telecopier and confirmed in writing sent by overnight or two-day courier service. 3.6 Titles and Subtitles The titles of the paragraphs and subparagraphs of this Agreement are for convenience of reference only and are not to be considered in construing this Agreement. 3.7 Litigation; Prevailing Party In the event of any litigation between the Corporation and the Investors with regard to this Agreement, the prevailing party shall be entitled to reimbursement from the nonprevailing party for all reasonable fees and expenses of counsel for the prevailing party. 3.8 Nominees Securities registered in the name of a nominee for a Holder shall, for purposes of this Agreement, be treated as being owned by such Holder. 3.9 Counterparts This Agreement may be executed in any number of counterparts, each of which shall be an original, but all of which together shall constitute one instrument. Delivery of a signed counterpart by and between telephone facsimile transmission shall between effective as delivery of a manually signed counterpart of this Agreement. IN WITNESS WHEREOF, the parties have executed this Registration Rights Agreement as of the date set forth above. BIOJECT MEDICAL TECHNOLOGIES INC. By:________________________________ Name: Peggy J. Miller Title: Vice President, Chief Financial Officer & Secretary INVESTOR Signature_____________________________ Print Name___________________________ Print Title____________________________ EX-4.3 6 1992 STOCK INCENTIVE PLAN, AS AMENDED. Exhibit 4.3 BIOJECT MEDICAL TECHNOLOGIES INC. 1992 STOCK INCENTIVE PLAN (as amended through July 25, 1996) 1. Purpose. The purpose of this 1992 Stock Incentive Plan (the "Plan") is to enable Bioject Medical Technologies Inc., an Oregon corporation (the "Company"), to attract and retain the services of (a) selected employees, officers and directors of the Company or of any parent or subsidiary corporation of the Company, and (b) selected nonemployee agents, consultants, advisers and independent contractors of the Company or any parent or subsidiary. 2. Shares Subject to the Plan. Subject to adjustment as provided below and in paragraph 11, up to 3,000,000 shares of Common Stock of the Company (the "Shares") shall be offered and issued under the Plan. If an option or a stock appreciation right granted under the Plan expires, terminates or is cancelled, the unissued Shares subject to such option or stock appreciation right shall again be available under the Plan. If Shares sold or awarded as a bonus under the Plan are forfeited to the Company or repurchased by the Company, the number of Shares forfeited or repurchased shall again be available under the Plan. 3. Effective Date and Duration of Plan. (a) Effective Date. The Plan shall become effective when adopted by the Board of Directors of the Company (the "Board"). However, no option granted under the Plan shall become exercisable until the Plan is approved by the affirmative vote of the holders of a majority of the Common Stock of the Company represented at a shareholder meeting at which a quorum is present, and any such awards under the Plan prior to such approval shall be conditioned on and subject to such approval. Subject to this limitation, options and stock appreciation rights may be granted and Shares may be awarded as bonuses or sold under the Plan at any time after the effective date and before termination of the Plan. (b) Duration. No options or stock appreciation rights may be granted under the Plan, no stock bonuses may be awarded under the Plan, and no Shares may be sold pursuant to paragraph 8 of the Plan on or after July 30, 2002. However, the Plan shall continue in effect until all Shares available for issuance under the Plan have been issued and all restrictions on such Shares have lapsed. The Board may suspend or terminate the Plan at any time, except with respect to options, stock appreciation rights and Shares subject to restrictions then outstanding under the Plan. Termination shall not affect any outstanding options, stock appreciation rights, any right of the Company to repurchase Shares or the forfeitability of Shares issued under the Plan. 4. Administration. (a) The Plan shall be administered by a committee appointed by the Board consisting of not less than two directors (the "Committee"). The Committee shall determine and designate from time to time the individuals to whom awards shall be made, the amount of the awards, and the other terms and conditions of the awards; provided, however, that only the Board may amend or terminate the Plan as provided in paragraphs 3 and 14. At any time when the officers and directors of the Company are subject to Section 16(b) of the Securities Exchange Act of 1934 (the "Exchange Act"), the Committee shall consist solely of "disinterested" directors as such term is defined from time to time in Rule 16b-3 under the Exchange Act. No member of the Committee shall be eligible to receive any award under the Plan while such person serves as a Committee member, except pursuant to paragraph 10. (b) Subject to the provisions of the Plan, the Committee may from time to time adopt and amend rules and regulations relating to administration of the Plan, advance the lapse of any waiting period, accelerate any exercise date, waive or modify any restriction applicable to Shares (except those restrictions imposed by law) and make all other determinations in the judgment of the Committee necessary or desirable for the administration of the Plan. The interpretation and construction of the provisions of the Plan and related agreements by the Committee shall be final and conclusive. The Committee may correct any defect or supply any omission or reconcile any inconsistency in the Plan or in any related agreement in the manner and to the extent it shall deem expedient to carry the Plan into effect, and it shall be the sole and final judge of such expediency. 5. Types of Awards; Eligibility. The Committee may, from time to time, take the following actions under the Plan: (i) grant Incentive Stock Options, as defined in Section 422 of the Internal Revenue Code of 1986, as amended (the "Code"), as provided in paragraph 6(b); (ii) grant options other than Incentive Stock Options ("Nonstatutory Stock Options") as provided in paragraph 6(c); (iii) award stock bonuses as provided in paragraph 7; (iv) sell Shares as provided in paragraph 8; and (v) grant stock appreciation rights as provided in paragraph 9. Any such awards may be made to employees (including employees who are officers or directors) of the Company or of any parent or subsidiary corporation of the Company, and to other individuals described in paragraph 1 who the Committee believes have made or will make an important contribution to the Company or its parent or subsidiaries; provided, however, that only employees of the Company or a parent or subsidiary shall be eligible to receive Incentive Stock Options under the Plan, and, provided further, that directors who are not employees shall receive awards only pursuant to paragraph 10. The Committee shall select the individuals to whom awards shall be made and shall specify the action taken with respect to each individual to whom an award is made under the Plan. At the discretion of the Committee, an individual may be given an election to surrender an award in exchange for the grant of a new award. 6. Option Grants (a) Grant. Each option granted under the Plan shall be evidenced by a stock option agreement in such form as the Committee shall prescribe from time to time in accordance with the Plan. With respect to each option grant, the Committee shall determine the number of Shares subject to the option, the option price, the period of the option, and the time or times at which the option may be exercised and whether the option is an Incentive Stock Option or a Nonstatutory Stock Option. (b) Incentive Stock Options. Incentive Stock Options granted under the Plan shall be subject to the following terms and conditions: (i) No employee may be granted Incentive Stock Options under the Plan such that the aggregate fair market value, on the date of grant, of the Shares with respect to which Incentive Stock Options are exercisable for the first time by that employee during any calendar year under the Plan and under any other incentive stock option plan (within the meaning of Section 422 of the Code) of the Company or of any parent or subsidiary corporation of the Company exceeds $100,000. (ii) An Incentive Stock Option may be granted under the Plan to an employee possessing more than 10 percent of the total combined voting power of all classes of stock of the Company or of any parent or subsidiary corporation of the Company only if the option price is at least 110 percent of the fair market value, as described in paragraph 6(b)(iv), of the Shares subject to the option on the date it is granted, and the option by its terms is not exercisable more than five years from the date of grant. (iii) Subject to paragraphs 6(b)(ii) and 6(d), Incentive Stock Options granted under the Plan shall continue in effect for the period fixed by the Committee, except that no Incentive Stock Option shall be exercisable more than 10 years from the date of grant. (iv) the option price per Share shall be determined by the Committee at the time of grant. Subject to paragraph 6(b)(ii), the option price shall not be less than 100 percent of the fair market value of the Shares covered by the Incentive Stock Option at the date the option is granted. The fair market value shall be deemed to be the average of the closing bid and asked prices for the Common Stock of the Company as reported on the National Association of Securities Dealers, Inc. Automated Quotation System on the day preceding the day the option is granted, or if there has been no sale on that date, on the last preceding date on which a sale occurred, or such other reported value of the Common Stock of the Company as shall be specified by the Committee. (v) The Committee may at any time without the consent of the optionee convert an Incentive Stock Option into a Nonstatutory Stock Option. (c) Nonstatutory Stock Options. Nonstatutory Stock Options shall be subject to the following additional terms and conditions: (i) The option price for Nonstatutory Stock Options shall be determined by the Committee at the time of grant. The option price may not be less than 75 percent of the fair market value of the Shares covered by the Nonstatutory Stock Option on the date of grant. The fair market value of the Shares covered by a Nonstatutory Stock Option shall be determined pursuant to paragraph 6(b)(iv). (ii) Nonstatutory Stock Options granted under the Plan shall continue in effect for the period fixed by the Committee. (d) Exercise of Options. Except as provided in paragraph 6(f) or as determined by the Committee, no option granted under the Plan may be exercised unless at the time of such exercise the optionee is employed by or in the service of the Company or any parent or subsidiary corporation of the Company and shall have been so employed or have provided such service continuously since the date such option was granted. Absence on leave or on account of illness or disability under rules established by the Committee shall not, however, be deemed an interruption of employment for purposes of the Plan. Unless otherwise determined by the Committee, vesting of options shall not continue during an absence on leave (including an extended illness) or on account of disability. No option may be exercised by an officer or director of the Company within six months of the date of grant. Except as provided in paragraphs 6(f), 11 and 12, options granted under the Plan may be exercised from time to time over the period stated in each option in such amounts and at such times as shall be prescribed by the Committee, provided that options shall not be exercised for fractional shares. Unless otherwise determined by the Committee, if the optionee does not exercise an option in any one year with respect to the full number of Shares to which the optionee is entitled in that year, the optionee's rights shall be cumulative and the optionee may purchase those Shares in any subsequent year during the term of the option. (e) Nontransferability. Each option granted under the Plan by its terms shall be nonassignable and nontransferable by the optionee, either voluntarily or by operation of law, except by will or by the laws of descent and distribution of the state or country of the optionee's domicile at the time of death, and each option by its terms shall be exercisable during the optionee's lifetime only by the optionee. (f) Termination of Employment or Service. (I) In the event the employment or service of the optionee by the Company or a parent or subsidiary corporation of the Company terminates for any reason other than because of death or physical disability, the option may be exercised at any time prior to the expiration date of the option or the expiration of three months after the date of such termination, whichever is the shorter period, but only if and to the extent the optionee was entitled to exercise the option at the date of such termination. (ii) In the event of the termination of the optionee's employment or service with the Company or a parent or subsidiary corporation of the Company because the optionee becomes disabled (within the meaning of Section 22(e)(3) of the Code), the option may be exercised at any time prior to the expiration date of the option or the expiration of one year after the date of such termination, whichever is the shorter period, but only if and to the extent the optionee was entitled to exercise the option at the date of such termination. (iii) In the event of the death of an optionee while employed by or providing service to the Company or a parent or subsidiary corporation of the Company, the option may be exercised at any time prior to the expiration date of the option or the expiration of one year after the date of such death, whichever is the shorter period, but only if and to the extent the optionee was entitled to exercise the option on the date of death, and only by the person or persons to whom such optionee's rights under the option shall pass by the optionee's will or by the laws of descent and distribution of the state or country of domicile at the time of death. (iv) The Committee, at the time of grant or at any time thereafter, may extend the three-month and one-year expiration periods any length of time not later than the original expiration date of the option, and may increase the portion of an option that is exercisable, subject to such terms and conditions as the Committee may determine. (v) To the extent that the option of any deceased optionee or of any optionee whose employment or service terminates is not exercised within the applicable period, all further rights to purchase Shares pursuant to such option shall cease and terminate. (g) Purchase of Shares. Unless the Committee determines otherwise, Shares may be acquired pursuant to an option only upon receipt by the Company of notice in writing from the optionee of the optionee's intention to exercise, specifying the number of Shares as to which the optionee desires to exercise the option and the date on which the optionee desires to complete the transaction, and, if required to comply with the Securities Act of 1933, as amended, or state securities laws, the notice shall include a representation that it is the optionee's present intention to acquire the Shares for investment and not with a view to distribution. The certificates representing the Shares shall bear any legends required by the Committee. Unless the Committee determines otherwise, on or before the date specified for completion of the purchase of Shares pursuant to an option, the optionee must have paid the Company the full purchase price of such Shares in cash (including, with the consent of the Committee, cash that may be the proceeds of a loan from the Company), or, with the consent of the Committee, in whole or in part, in Shares valued at fair market value, as determined pursuant to paragraph 6(b)(iv). Unless the Committee determines otherwise, all payments made to the Company in connection with the exercise of an option must be made by a certified or cashier's bank check or by the transfer of immediately available federal funds. No Shares shall be issued until full payment therefor has been made. With the consent of the Committee, an optionee may request the Company to apply automatically the Shares to be received upon the exercise of a portion of a stock option (even though stock certificates have not yet been issued) to satisfy the purchase price for additional portions of the option. Each optionee who has exercised an option shall immediately upon notification of the amount due, if any, pay to the Company in cash amounts necessary to satisfy any applicable federal, state and local tax withholding requirements. If additional withholding is or becomes required beyond any amount deposited before delivery of the certificates, the optionee shall pay such amount to the Company on demand. If the optionee fails to pay the amount demanded, the Company or any parent or subsidiary corporation of the Company may withhold that amount from other amounts payable to the optionee by the Company or the parent or subsidiary corporation, including salary, subject to applicable law. With the consent of the Committee, an optionee may deliver Shares to the Company to satisfy the withholding obligation. 7. Stock Bonuses. The Committee may award Shares under the Plan as stock bonuses. Shares awarded as a stock bonus shall be subject to such terms, conditions, and restrictions as shall be determined by the Committee, all of which shall be evidenced in a writing signed by the recipient prior to receiving the bonus Shares. The Committee may not require the recipient to pay any monetary consideration other than amounts necessary to satisfy tax withholding requirements. The certificates representing the Shares awarded shall bear any legends required by the Committee. The Company may require any recipient of a stock bonus to pay to the Company in cash upon demand amounts necessary to satisfy any applicable federal, state or local tax withholding requirements. If the recipient fails to pay the amount demanded, the Company or any parent or subsidiary corporation of the Company may withhold that amount from other amounts payable to the recipient by the Company or the parent or subsidiary corporation, including salary, subject to applicable law. With the consent of the Committee, a recipient may deliver Shares to the Company to satisfy the withholding obligation. 8. Stock Sales. The Committee may issue Shares under the Plan for such consideration (including promissory notes and services) as determined by the Committee, provided that in no event shall the consideration be less than 75 percent of the fair market value of the Shares at the time of issuance, determined pursuant to paragraph 6(b)(iv). Shares issued under this paragraph 8 shall be subject to the terms, conditions and restrictions determined by the Committee. The restrictions may include restrictions concerning transferability, repurchase by the Company and forfeiture of the Shares issued, together with such other restrictions as may be determined by the Committee. The certificates representing the Shares shall bear any legends required by the Committee. The Company may require any purchaser of stock issued under this paragraph 8 to pay to the Company in cash upon demand amounts necessary to satisfy any applicable federal, state or local tax withholding requirements. If the purchaser fails to pay the amount demanded, the Company or any parent or subsidiary corporation of the Company may withhold that amount from other amounts payable to the purchaser by the Company or any parent or subsidiary corporation, including salary, subject to applicable law. With the consent of the Committee, a purchaser may deliver Shares to the Company to satisfy the withholding obligation. 9. Stock Appreciation Rights. (a) Grant. Stock appreciation rights may be granted under the Plan by the Committee, subject to such rules, terms, and conditions as the Committee prescribes. (b) Exercise. (I) A stock appreciation right shall be exercisable only at the time or times established by the Committee. If a stock appreciation right is granted in connection with an option, the stock appreciation right shall be exercisable only to the extent and on the same conditions that the related option could be exercised. Upon exercise of a stock appreciation right, any option or portion thereof to which the stock appreciation right relates terminates. If a stock appreciation right is granted in connection with an option, upon exercise of the option, the stock appreciation right or portion thereof to which the option relates terminates. No stock appreciation right granted to an officer or director may be exercised during the first six months following the date of grant. (ii) The Committee may withdraw any stock appreciation right granted under the Plan at any time and may impose any conditions upon the exercise of a stock appreciation right or adopt rules and regulations from time to time affecting the rights of holders of stock appreciation rights. Such rules and regulations may govern the right to exercise stock appreciation rights granted before adoption or amendment of such rules and regulations as well as stock appreciation rights granted thereafter. (iii) Each stock appreciation right shall entitle the holder, upon exercise, to receive from the Company in exchange therefor an amount equal in value to the excess of the fair market value on the date of exercise of one Share over its fair market value on the date of grant (or, in the case of a stock appreciation right granted in connection with an option, the option price per Share under the option to which the stock appreciation right relates), multiplied by the number of Shares covered by the stock appreciation right or the option, or portion thereof, that is surrendered. No stock appreciation right shall be exercisable at a time that the amount determined under this subparagraph is negative. Payment by the Company upon exercise of a stock appreciation right may be made in Shares valued at fair market value, in cash, or partly in Shares and partly in cash, all as determined by the Committee. (iv) For purposes of this paragraph 9, the fair market value of the Shares shall be determined pursuant to paragraph 6(b)(iv), on the trading day preceding the date the stock appreciation right is exercised. (v) No fractional Shares shall be issued upon exercise of a stock appreciation right. In lieu thereof, cash may be paid in an amount equal to the value of the fraction or, if the Committee shall determine, the number of Shares may be rounded downward to the next whole Share. (vi) Each participant who has exercised a stock appreciation right shall, upon notification of the amount due, pay to the Company in cash amounts necessary to satisfy any applicable federal, state or local tax withholding requirements. If the participant fails to pay the amount demanded, the Company or any parent or subsidiary corporation of the Company may withhold that amount from other amounts payable to the participant by the Company or any parent or subsidiary corporation, including salary, subject to applicable law. With the consent of the Committee, a participant may satisfy this obligation, in whole or in part, by having the Company withhold from any Shares to be issued upon the exercise that number of Shares that would satisfy the withholding amount due or by delivering Shares to the Company to satisfy the withholding amount. (vii) Upon the exercise of a stock appreciation right for Shares, the number of Shares reserved for issuance under the Plan shall be reduced by the number of Shares issued. Cash payments of stock appreciation rights shall not reduce the number of Shares reserved for issuance under the Plan. 10. Option Grants to Non-Employee Directors. (a) Automatic Grants. Immediately after the close of each annual shareholder meeting (commencing with the 1993 annual meeting), each person then serving as a Non-Employee Director, including any such person who is elected at such meeting, shall automatically be granted a Nonstatutory Stock Option to purchase 17,500 Shares. A "Non-Employee Director" is a director of the Company who is not an employee of the Company or of any parent or subsidiary corporation of the Company on the date the option is granted. (b) Terms of Options. The exercise price for options granted under this paragraph 10 shall be the fair market value of the Shares on the date of grant, determined pursuant to paragraph 6(b)(iv). Each such option shall have an eight-year term from the date of grant, unless earlier terminated as provided in paragraph 6(f), and shall become exercisable with respect to 8,750 shares six months after the date of grant, with the remaining 8,750 shares becoming exercisable on the first anniversary of the date of grant. 11. Changes in Capital Structure. If the outstanding shares of Common Stock of the Company are hereafter increased or decreased or changed into or exchanged for a different number or kind of shares or other securities of the Company or of another corporation by reason of any recapitalization, reclassification, stock split, combination of shares or dividend payable in shares, the Committee shall make appropriate adjustments (i) in the number and kind of shares available for awards under the Plan; and (ii) in the number and kind of shares as to which outstanding options and stock appreciation rights, or portions thereof then unexercised, shall be exercisable, so that the participant's proportionate interest before and after the occurrence of the event is maintained, provided that this paragraph 11 shall not apply with respect to transactions referred to in paragraph 12. The Committee may also require that any securities issued in respect of or exchanged for Shares issued hereunder that are subject to restrictions be subject to similar restrictions. Notwithstanding the foregoing, the Committee shall have no obligation to effect any adjustment that would or might result in the issuance of fractional shares, and any fractional shares resulting from any adjustment may be disregarded or provided for in any manner determined by the Committee. Any such adjustment made by the Committee shall be conclusive. 12. Effect of Reorganization or Liquidation. (a) Cash, Stock or Other Property for Stock. Except as provided in paragraph 12(b), upon a merger, consolidation, reorganization, plan of exchange or liquidation involving the Company, as a result of which the shareholders of the Company receive cash, stock or other property in exchange for or in connection with their Common Stock (any such transaction to be referred to in this paragraph 12 as an "Accelerating Event"), any option or stock appreciation right granted hereunder shall terminate, except as specified in the following sentence, but the optionee shall have the right during a 30-day period immediately prior to any such Accelerating Event to exercise his or her option or stock appreciation right, in whole or in part, without any limitation on exercisability. With respect to an option or stock appreciation right granted to an officer or director less than six months prior to any Accelerating Event, such officer or director shall have the right to require the Company to purchase such option or stock appreciation right at a purchase price computed pursuant to paragraph 12(c) during the 30-day period following the expiration of six months following the date of such grant, and this right shall apply even if the option or stock appreciation right has otherwise terminated pursuant to paragraph 6(f) following such Accelerating Event. (b) Stock for Stock. If the shareholders of the Company receive capital stock of another corporation ("Exchange Stock") in exchange for their Common Stock in any transaction involving a merger, consolidation, reorganization, or plan of exchange, all options granted hereunder shall be converted into options to purchase shares of Exchange Stock and all stock appreciation rights granted hereunder shall be converted into stock appreciation rights measured by the Exchange Stock, unless the Committee, in its sole discretion, determines that any or all such options or stock appreciation rights granted hereunder shall not be converted, but instead shall terminate in accordance with the provisions of paragraph 12(a). The amount and price of converted options and stock appreciation rights shall be determined by adjusting the amount and price of the options or stock appreciation rights granted hereunder to take into account the relative values of the Exchange Stock and the Common Stock in the transaction. (c) Purchase Price. With respect to an option granted to an officer or director less than six months prior to an Accelerating Event, the purchase price payable pursuant to paragraph 12(a) shall be computed as follows: (i) With respect to a Nonstatutory Stock Option and a stock appreciation right as to which no Incentive Stock Option has been granted, the purchase price shall be the product of (A) the excess, if any, of the higher of (1) the purchase price paid for each Share in the Accelerating Event, or (2) the highest fair market value of a Share (determined pursuant to paragraph 6(b)(iv)) during the 30-day period ending on the day the Accelerating Event occurs, over the option price, and (B) the number of Shares covered by the option or stock appreciation right. (ii) With respect to an Incentive Stock Option and a stock appreciation right as to which an Incentive Stock Option has been granted, the purchase price shall be the product of (A) the excess, if any, of the fair market value of each Share on the date of exercise over the option price, and (B) the number of Shares covered by the option or stock appreciation right. (iii) No option or stock appreciation right may be exercised in connection with an Accelerating Event if the purchase price determined under this paragraph 12(c)is negative. (d) The rights set forth in this paragraph 12 shall be transferable only to the extent the related option or stock appreciation right is transferable. 13. Corporate Mergers, Acquisitions, Etc. The Committee may also grant options, grant stock appreciation rights, award stock bonuses and sell stock under the Plan having terms, conditions and provisions that vary from those specified in the Plan; provided that any such awards are granted in substitution for, or in connection with the assumption of, existing options, stock appreciation rights, stock bonuses and stock sold or awarded by another corporation and assumed or otherwise agreed to be provided for by the Company pursuant to or by reason of a transaction involving a corporate merger, consolidation, acquisition of property or stock, separation, reorganization or liquidation to which the Company or a parent or subsidiary corporation of the Company is a party. 14. Amendment of Plan. (a) The Board may at any time, and from time to time, modify or amend the Plan in such respects as it shall deem advisable because of changes in the law while the Plan is in effect or for any other reason. Except as provided in paragraphs 6(b)(v), 11, 12 and 13, however, no change in an award already granted shall be made without the written consent of the holder of such award. (b) Notwithstanding any other provision in the Plan, paragraph 10 may be amended or modified by the Board or the shareholders of the Company only once in any six-month period, except as may be required to comport with changes in the Code, or the Employee Retirement Income Security Act, or the rules promulgated thereunder. 15. Approvals. The obligations of the Company under the Plan are subject to the approval of state and federal authorities or agencies with jurisdiction in the matter. The Company shall not be obligated to issue or deliver Shares under the Plan if such issuance or delivery would violate applicable state or federal securities laws, or if compliance with such laws would, in the opinion of the Company, be unduly burdensome or require the disclosure of information which would not be in the Company's best interests. 16. Employment and Service Rights. Nothing in the Plan or any award pursuant to the Plan shall (i) confer upon any employee any right to be continued in the employment of the Company or any parent or subsidiary corporation of the Company or shall interfere in any way with the right of the Company or any parent or subsidiary corporation of the Company by whom such employee is employed to terminate such employee's employment at any time, for any reason, with or without cause, or to increase or decrease such employee's compensation or benefits; or (ii) confer upon any person engaged by the Company or any parent or subsidiary corporation of the Company any right to be retained or employed by the Company or the parent or subsidiary or to the continuation, extension, renewal, or modification of any compensation, contract, or arrangement with or by the Company or the parent or subsidiary. 17. Rights as a Shareholder. The recipient of any award under the Plan shall have no rights as a shareholder with respect to any Shares until the date of issue to the recipient of a stock certificate for such Shares. Except as otherwise expressly provided in the Plan, no adjustment shall be made for dividends or other rights for which the record date is prior to the date such stock certificate is issued.
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