-----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, GySKgkl6l4JcrDo+YK0GeM6LrJZmcFukYV+Cim1plWKdzvdSdv01yPUgCOAmUtgK gAXbGHvjcg0ld5kZlbgFuA== 0001017062-99-001562.txt : 19990902 0001017062-99-001562.hdr.sgml : 19990902 ACCESSION NUMBER: 0001017062-99-001562 CONFORMED SUBMISSION TYPE: S-3/A PUBLIC DOCUMENT COUNT: 4 FILED AS OF DATE: 19990901 FILER: COMPANY DATA: COMPANY CONFORMED NAME: BIOLASE TECHNOLOGY INC CENTRAL INDEX KEY: 0000811240 STANDARD INDUSTRIAL CLASSIFICATION: DENTAL EQUIPMENT & SUPPLIES [3843] IRS NUMBER: 870442441 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: S-3/A SEC ACT: SEC FILE NUMBER: 333-58329 FILM NUMBER: 99704719 BUSINESS ADDRESS: STREET 1: 981 CALLE AMANECER CITY: SAN CLEMENTE STATE: CA ZIP: 92673 BUSINESS PHONE: 7143611200 MAIL ADDRESS: STREET 1: 981 CALLE AMANECER CITY: SAN CLEMENTE STATE: CA ZIP: 92673 S-3/A 1 AMENDMENT NO. 3 TO FORM S-3 As filed with the Securities and Exchange Commission on September 1, 1999 Registration No. 333-58329 - -------------------------------------------------------------------------------- SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 ____________________ AMENDMENT NO. 3 TO FORM S-3 REGISTRATION STATEMENT Under The Securities Act of 1933 ____________________ BIOLASE TECHNOLOGY, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 3845 87-0442441 (State or Other Jurisdiction of (Primary Standard Industrial (I.R.S. Employer Incorporation or Organization) Classification Code Number) Identification Number)
981 Calle Amanecer, San Clemente, California 92673 (949) 361-1200 (Address, Including Zip Code, and Telephone Number, Including Area Code, of Principal Executive Offices) Federico Pignatelli Chairman of the Board BioLase Technology, Inc. 981 Calle Amanecer San Clemente, California 92673 (949) 361-1200 (Name, Address and Telephone Number of Agent for Service) Copies of Communications to: Alan D. Jacobson, Esq. Kelly Lytton Mintz & Vann LLP 1900 Avenue of the Stars, Suite 1450 Los Angeles, California 90067 (310) 277-5333 Telecopier No.: (310) 277-1804 APPROXIMATE DATE OF COMMENCEMENT OF PROPOSED SALE TO PUBLIC: As soon as practicable after this Registration Statement becomes effective. If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, as amended, check the following box: [X]
=================================================================================================================================== CALCULATION OF REGISTRATION FEE - ----------------------------------------------------------------------------------------------------------------------------------- Title of each class of Amount Proposed maximum Proposed maximum securities to be to be offering price aggregate offering Amount of registered registered per unit price registration fee - ----------------------------------------------------------------------------------------------------------------------------------- Common Stock, $.001 par value 1,336,600 shares $3.125 (1) $ 4,176,875 (1) $1,161.17 (1) - ----------------------------------------------------------------------------------------------------------------------------------- Common Stock, $.001 par value 100,000 shares $5.00 (2) $ 500,000 (2) $ 110.63 (2) - ----------------------------------------------------------------------------------------------------------------------------------- Common Stock, $.001 par value 25,000 shares $4.00 (2) $ 100,000 (2) $ 29.50 (2) - ----------------------------------------------------------------------------------------------------------------------------------- Common Stock, $.001 par value 724,000 shares $3.75 (2) $ 2,715,000 (2) $ 800.93 (2) - ----------------------------------------------------------------------------------------------------------------------------------- Common Stock, $.001 par value 1,134,300 shares $2.375(1) $ 2,693,963 (1) $ 748.92 (1) - ----------------------------------------------------------------------------------------------------------------------------------- Common Stock, $.001 par value 550,000 shares $3.50 (2) $ 1,925,000 (2) $ 535.15 (2) - ----------------------------------------------------------------------------------------------------------------------------------- Common Stock, $.001 par value 99,000 shares $2.75 (2) $ 272,250 (2) $ 75.69 (2) - ----------------------------------------------------------------------------------------------------------------------------------- Common Stock, $.001 par value 51,300 shares $2.59375 $ 133,059 (1) $ 36.99 (1) - ----------------------------------------------------------------------------------------------------------------------------------- Total 4,020,200 shares $12,516,147 $3,498.98 (3) ===================================================================================================================================
(1) Calculated in accordance with Rule 457(c). (2) Calculated in accordance with Rule 457(g). (3) $2,422.13 of said amount has previously been paid. The Registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment which specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until this Registration Statement shall become effective on such date as the Commission, acting pursuant to Section 8(a), may determine. PROSPECTUS 4,020,200 Shares BIOLASE TECHNOLOGY, INC. Common Stock _______________ This Prospectus relates to an aggregate of 4,020,200 shares of common stock, $.001 par value ("Common Stock") of BioLase Technology, Inc., a Delaware corporation ("BioLase" and, together with its consolidated subsidiary, the "Company"), heretofore issued to the persons listed herein (the "Selling Stockholders"), or issuable to the Selling Stockholders pursuant to, among other things, the exercise of the Company's Common Stock Purchase Warrants (the "Warrants"). Such shares of Common Stock are being offered for the respective accounts of the Selling Stockholders on The Nasdaq SmallCap Market at the then- prevailing prices, or in negotiated transactions. The Common Stock is traded on The Nasdaq SmallCap Market under the symbol "BLTI". On August 23, 1999, the last sale price of the Common Stock as reported on The Nasdaq SmallCap Market was $2.75 per share. The Company will receive no proceeds from the sale of such shares of Common Stock by the Selling Stockholders; however, it will receive proceeds from the exercise of the Warrants. See "Use of Proceeds". The expenses of preparing and filing the Registration Statement, of which this Prospectus forms a part (estimated at $45,000), are being paid by the Company. _______________ SEE "RISK FACTORS" BEGINNING ON PAGE 3 FOR A DISCUSSION OF CERTAIN FACTORS THAT SHOULD BE CONSIDERED BY PROSPECTIVE INVESTORS. _______________ THESE SECURITIES HAVE NOT BEEN APPROVED OR DISAPPROVED BY THE SECURITIES AND EXCHANGE COMMISSION OR ANY STATE SECURITIES COMMISSION, NOR HAS THE SECURITIES AND EXCHANGE COMMISSION OR ANY STATE SECURITIES COMMISSION PASSED UPON THE ACCURACY OR ADEQUACY OF THIS PROSPECTUS. ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENSE. _______________ The shares offered hereby were or will be acquired by the Selling Stockholders from the Company in private placements or upon the exercise of the Warrants and are "restricted securities" under the Securities Act of 1933, as amended (the "Securities Act"). This Prospectus has been prepared for the purpose of registering the shares under the Securities Act to allow for future sales by the Selling Stockholders to the public without restriction. To the knowledge of the Company, the Selling Stockholders have made no arrangement with any brokerage firm for the sale of the shares. The Selling Stockholders may be deemed "underwriters" within the meaning of the Securities Act. Any commissions received by a broker or dealer in connection with resales of the shares may be deemed underwriting commissions or discounts under the Securities Act. See "Plan of Distribution". The date of this Prospectus is September __, 1999. 1 AVAILABLE INFORMATION The Company is subject to the informational requirements of the Securities Exchange Act of 1934 (the "Exchange Act") and in accordance therewith files annual and quarterly reports, proxy statements and other information with the Securities and Exchange Commission (the "Commission"). Such reports, proxy statements and other information concerning the Company can be inspected at the Commission's Public Reference Section, Room 1024, 450 Fifth Street, N.W., Washington, D.C. 20549, as well as at the Commission's regional offices at 7 World Trade Center, 13th Floor, New York, New York 10048 and at Citicorp Center, 500 West Madison Street, Room 1400, Chicago, Illinois 60661-2511. Copies of such material can also be obtained at prescribed rates at the Public Reference Section of the Commission at 450 Fifth Street, N.W., Washington, D.C. 20549. In addition, the Commission maintains a World Wide Web site on the Internet at http:\\www.sec.gov that contains reports, proxy and information statements and other information regarding registrants, including the Company, that file electronically with the Commission. PROSPECTUS SUMMARY The following summary is qualified in its entirety by the more detailed information and financial statements appearing elsewhere in this Prospectus or incorporated herein by reference. The factors discussed below under "Risk Factors - Forward Looking Statements" and elsewhere in this Prospectus, including documents incorporated herein by reference, are among certain risks, uncertainties and other factors that in some cases have affected BioLase's historic results and could cause actual results in the future to differ significantly from the results anticipated in forward looking statements made in this Prospectus, including documents incorporated herein by reference, in future filings by BioLase with the Commission, in BioLase's press releases and in oral statements made by authorized officers of BioLase. When used in this Prospectus, including documents incorporated herein by reference, the words "estimate", "project", "anticipate", "expect", "intend", "believe", "hope", "may" and similar expressions, as well as "will", "shall" and other indications of future tense, are intended to identify forward looking statements. THE COMPANY BioLase Technology, Inc., a Delaware corporation ("BioLase" and, together with its consolidated subsidiary, the "Company"), designs, develops, manufactures and markets laser-based systems for use in dental and medical applications. The current generation of the Company's laser-based systems incorporates its proprietary technology ("HydroKinetic(TM)") into its surgical tissue cutting system ("Millennium(TM)"), which utilizes electromagnetic energy laser pulses from an erbium, chromium: yttrium scandium gallium garnet ("Er,Cr: YSGG") laser and a proprietary air-water spray. In a configuration utilizing higher power settings, the laser pulses act to rapidly energize and transform atomized water droplets from the air-water spray into smaller, energized water molecules that can precisely remove both dental hard and soft tissues, and the Millennium(TM) system, when operating in this manner, is intended for use primarily in hard tissue applications. In a configuration utilizing lower power settings, the Er,Cr: YSGG laser incorporated into the Millennium(TM) system acts as a conventional laser, with the air-water spray serving as a cooling agent. When operating in this manner, the Millennium(TM) system is intended for use in soft tissue applications. The Millennium(TM) system is currently marketed in the United States and Europe for hard and soft tissue dental applications. See "Risk Factors -- Need to Establish Marketing Arrangements for Millennium(TM)". The Company also has (i) an automated system used in endodontic procedures for locating and shaping root canals, known as the Canal Finder System(TM), along with a full range of other proprietary and non-proprietary endodontic products, and (ii) an air-water spray laser accessory, LaserSpray(TM), designed to cool the tissue receiving laser energy and the surrounding tissue, that is incorporated into the Company's laser-based systems and can be employed with fiber-coupled laser systems manufactured by others. The Company has developed a home consumer product called LazerSmile(TM), a toothbrush that utilizes a light source and a proprietary gel for whitening teeth. The Company has recently licensed the manufacturing and distribution rights of its LazerSmile(TM) product to a home-consumer product distributor for which the Company shall receive future royalties based on sales. See "Recent Developments". The Company has under development a fluid conditioning system known as FlavorFlow(TM), for which it has been granted a patent, that sanitizes, flavors and administers fluids and enhances the scent of air present during dental and medical procedures, and a line of biomaterials for dental and medical applications. 2 The Company's principal executive offices are located at 981 Calle Amanecer, San Clemente, California 92673, and its telephone number at that location is (949) 361-1200. Recent Developments - ------------------- During the second quarter of 1999, the Company announced an exclusive distribution agreement with a home-consumer product distributor to manufacture and market the Company's LazerSmile(TM) Tooth Whitening System under the name IGEA LazerWhite Tooth Whitening System. The agreement provides for a royalty to be paid to the Company based on units sold and provides for minimum annual sales of 500,000 units in order for the distributor to maintain its rights. The Company has received prepaid royalties and will recognize such royalties as revenue when sales commence, which is expected in the later part of the third quarter of 1999. THE OFFERING Common Stock offered hereby....................... 4,020,200 shares Common Stock to be outstanding after this Offering.............................. 19,259,215 shares(1) Use of proceeds................................... The Company will not receive any portion of the proceeds from the Common Stock to be sold in this Offering; however, it will receive proceeds from the exercise of Warrants, which proceeds will be used for working capital and general corporate purposes. See "Use of Proceeds".
_______________ (1) Based on the number of shares outstanding at August 23, 1999. Assumes exercise of the Warrants; excludes (i) 2,856,191 shares of Common Stock, not being registered hereunder, reserved for issuance upon exercise of other warrants and options outstanding at August 23, 1999; and (ii) 635,899 shares of Common Stock otherwise reserved for possible issuance under the Company's 1990, 1992, 1993 and 1998 Stock Option Plans and 1990 and 1993 Stock Compensation Plans. RISK FACTORS THIS OFFERING INVOLVES SUBSTANTIAL INVESTMENT RISK, AND THE SHARES SHOULD BE PURCHASED ONLY BY PERSONS WHO CAN AFFORD THE LOSS OF THEIR ENTIRE INVESTMENT. IN EVALUATING AN INVESTMENT IN SHARES OF THE COMPANY, PROSPECTIVE INVESTORS SHOULD CAREFULLY CONSIDER THE FOLLOWING RISK FACTORS, AMONG OTHERS, AS WELL AS ALL OTHER INFORMATION SET FORTH HEREIN, INCLUDING THE EXHIBITS HERETO. THE FOLLOWING DISCUSSION OF RISK FACTORS IS NOT COMPREHENSIVE, AND EACH PROSPECTIVE INVESTOR IS ADVISED TO MAKE ITS OWN ANALYSIS OF THE RISKS ASSOCIATED WITH AN INVESTMENT IN THE SHARES. 1. History of Net Losses; Future Profitability Uncertain. The Company ----------------------------------------------------- reported net losses of $7,549,262, $3,050,333, $2,023,822, $2,463,259, $2,823,910 and $10,346,069 for the years ended December 31, 1993, 1994, 1995, 1996, 1997 and 1998, respectively and net losses of $2,032,262 and $1,915,408 for the six-month periods ended June 30, 1998 and 1999, respectively. The Company had an accumulated deficit of $37,969,408 and 39,884,816 at December 31, 1998 and June 30, 1999, respectively. During the past five years, the Company has not generated sufficient revenue to permit it to operate on a profitable basis. The Company's ability to achieve profitable operations in the future will depend in large part upon obtaining regulatory approvals for the marketing of various products for certain applications and then successfully bringing its products to market and generating sufficient revenue to produce a net profit. The likelihood of long-term success of the Company must be considered in light of the expenses, difficulties and delays frequently encountered in the development and commercialization of new products and competitive factors in the marketplace, as well as the burdensome regulatory environment in which the Company operates. There can be no assurance that the Company will ever achieve significant revenues or profitable operations. 2. Viability as Going Concern; Need for Additional Funding. The Company has ------------------------------------------------------- suffered recurring losses from operations and shows a need for continued funding that raises substantial doubt about its ability to continue as a going concern. The Company's ability to continue as a going concern is dependent upon its ability to obtain outside financing through the issuance of either additional shares of its Common or Preferred Stock or debt securities and, ultimately, upon a movement to profitability through increased sales, product improvement through engineering and cost containment. The Company's capital requirements depend on numerous factors, including the progress of its research and development programs, the progress of pre-clinical and clinical testing, the time and cost involved in obtaining regulatory approvals, the cost of filing, prosecuting, defending and enforcing patent claims and other intellectual property rights, competing technological and market developments, demand for its products, and payment terms it is able to negotiate with its suppliers and customers. 3 The Company has available a $2,500,000 credit facility to finance inventory and accounts receivable, of which $1,341,925 was outstanding at June 30, 1999. The current revolving credit agreement expires on December 1, 1999, by which time the Company hopes to negotiate a renewal of the present line with its present bank or establish a replacement line with another bank. The Company will be required to renew, pay off or refinance the existing line of credit by December 1, 1999. No assurances can be given that the Company will be able to renew or refinance the line of credit or that the terms on which it may be able to renew or refinance the line of credit will be as favorable as the terms of the existing line. If the Company is unable to renew or refinance and therefore is required to repay the line of credit, the diversion of resources to that purpose may adversely affect the Company's operations and financial condition. The Company remains dependent upon its ability to obtain outside financing either through the issuance of additional shares of its common or preferred stock or through borrowings until it achieves sustained profitability through increased sales and cost containment. In March 1999, the Company raised approximately $2,748,000 of net proceeds through a private placement of equity securities. The Company believes that increased sales of its Millennium(TM) system for certain dental hard and soft tissue procedures in the United States should contribute to the Company's ability to generate working capital. However, management believes that the Company will require significant capital resources during 1999 to fund its present operations, to fund efforts directed towards further extensions and refinements of existing products, and to fund continuing research and development activities. Combined with the capital generated from the prior issuance and sale of securities, the Company expects to generate the necessary cash flow through the sales of its products to fund its 1999 business plan. Should its current operations fall short of providing such resources, the Company would need to obtain the necessary capital resources through other sources such as debt or equity financing. No assurances can be given, however, that the Company will be able to achieve and sustain positive cash flow or profitability or have other sources available to provide the financial resources necessary to continue its operations. If the Company is unsuccessful in generating resources from one or more of the anticipated sources and is unable to replace any shortfall with resources from another source, the Company may be able to extend the period for which available resources would be adequate by deferring the creation or satisfaction of various commitments, deferring the introduction of various products or entry into various markets, and otherwise scaling back operations. If the Company were unable to generate the required resources, its ability to meet its obligations and to continue its operations would be adversely affected. The Company's consolidated financial statements do not include any adjustments that might result from the outcome of the uncertainty about the Company's ability to continue as a going concern. The Company's financial statements for the year ended December 31, 1998 were audited by the Company's independent accountants, whose report includes an explanatory paragraph stating that the financial statements have been prepared assuming the Company will continue as a going concern and that the Company has recurring losses and shows a need for continued funding that raise substantial doubt about its ability to continue as a going concern. 3. Product Development; Risk of Defects. The development of new technology ------------------------------------ is a lengthy and capital intensive process and is subject to unforeseen risks, delays, problems, and costs. The Company's success will in part depend upon its ability to design, develop and introduce new products and enhancements on a timely basis to meet changing customer needs, technological developments and evolving industry standards. There can be no assurance that the Company will be able successfully to develop any additional products, including products currently under development, or enhance existing products. Unanticipated technical or other problems may occur which could delay the Company's development programs. Failure to complete development of key products could result in the complete loss of the funds committed by the Company to such products, which could be substantial. In addition, products as complex as the Company's laser-based systems may contain latent defects which could from time to time become apparent during commercial use. Remedying such defects could require significant modifications at substantial costs to the Company. 4. Concentration of Sales in Foreign Distributors; Need to Establish ----------------------------------------------------------------- Marketing Arrangements for Millennium(TM). During 1998, two ----------------------------------------- distributors, Sweden & Martina, the Company's Italian distributor, and Ash Temple, the Company's Canadian distributor, accounted for approximately 20% and 11%, respectively, of the Company's sales. During 1997, Orbis Hi-Tech Dental GmbH, the Company's German distributor, accounted for approximately 67% of the Company's sales. During 1998, the Company made no sales of Millennium(TM) systems to Orbis Hi-Tech, while the Company was engaged in the redesign of the handpiece for the Millennium(TM) system. During the fourth quarter of 1998, the Company received FDA clearance to market the Millennium(TM) system in the United States for certain hard tissue dental applications. Now that clearance has been obtained to market the Millennium(TM) system in the United States, the Company is attempting to establish effective marketing arrangements to generate revenue from the Millennium(TM) system in a number of markets, including the United States. No assurances can be given that the Company will be successful in establishing effective marketing arrangements for Millennium(TM) in the United States or in other markets or that the Company will generate significant revenue from the sale of Millennium(TM) systems. 5. Uncertainty of Product and Market Acceptance. The Company is only in the -------------------------------------------- initial phases of the marketing of its HydroKinetic(TM) tissue cutting system, the Millennium(TM) system. Initial sales to a German distributor commenced during the second quarter of 1997, and domestic sales commenced in November 1998 following dental hard tissue clearance from the FDA. In July 1997, the Company received FDA clearance to market a laser system incorporating a variation of the technology utilized in the Millennium(TM) for a broad range of dermatological and general surgical soft tissue applications. In this variation, the utilization of lower power laser pulses does not result in the transformation of water droplets into energized water molecules capable of removing dental hard and soft tissues, but rather the air-water spray acts as a cooling agent. There can be no assurance that the Millennium(TM) system, including the dermatological and general soft tissue configuration, will receive market acceptance. Lasers have not been widely used in certain medical and dental applications, and their effective use requires training and experience. The acceptance of lasers may be adversely affected by their high cost, concerns by patients and practitioners about their safety and efficacy, and the substantial market acceptance and penetration of conventional dental and medical tools. Current economic pressure may make dental and medical practitioners reluctant to purchase substantial capital equipment or invest in new technology. The failure of dental and medical lasers to achieve broad market acceptance would have a material adverse effect on the Company's business, financial condition and results of operations. While the Company believes that the technology incorporated in its Millennium(TM) surgical tissue cutting system should be effective in a broad range of medical and dental applications, this belief (except with respect to dental hard tissue and certain dermatological applications, for which clinical research has been conducted) is based largely on preliminary in vitro and in vivo research and extrapolation of observations in such clinical research. No assurances can be given that the technology incorporated in its Millennium(TM) surgical tissue cutting system will prove to be applicable to, or will find market acceptance in, any medical or dental fields or that the Company will receive clearance from the FDA or other regulatory agencies to market the Millennium(TM) or any other laser-based system or other products embodying its HydroKinetic(TM) technology in any additional jurisdictions or for any additional applications. No assurances can be given that any other technologies or products that the Company is developing will prove effective or will find market acceptance. Since the clearance by the FDA to market the Millennium(TM) in the United States for hard tissue applications which the Company received in the fourth quarter of 1998, the Company has reported significantly higher sales due principally to the ability to actively market the Millennium(TM) product in the United States. While sales of the Company's laser-based systems in the second quarter of 1999 significantly exceeded those reported in the same period of 1998, 1999 second quarter sales were lower than anticipated and less than those of the first quarter of 1999 due principally to problems associated with certain supplier component changes and deficiencies. These supplier related component changes and deficiencies required the Company to redesign certain subassemblies to accommodate available components. Some residual effects of the supplier deficiencies are expected to carry into the first part of the third quarter of 1999; however, such supplier deficiencies are expected to be fully resolved during the third quarter of 1999. There can be no assurance that the Company will not encounter similar component related problems in the future or that the level of sales presently experienced will increase or be sustained in the future. Should the Company experience future componentry problems or should sales diminish in future periods, the Company's operations and working capital position would be adversely affected. In August 1998, the Company introduced its first consumer product, the LazerSmile(TM) Tooth Whitening System, which utilizes a monochromatic optical energy light source embedded within a toothbrush in conjunction with a clear, non-abrasive tooth whitening gel. In mid-1999, the Company licensed the manufacturing and distribution of its LazerSmile(TM) technology to a home- consumer product distributor for future royalties based on sales in order to dedicate its resources to the further development and marketing of its Millennium(TM) laser system and related products. See "Recent Developments". In 1998, the Company added a diode and an argon laser system to its product line. Both lasers are manufactured by unaffiliated third parties and are soft tissue and composite curing lasers, respectively, intended for use within the dental market. There can be no assurance that these systems will receive market acceptance or that significant revenues will be realized in the future. In the future, the Company may introduce additional products. There can be no assurance that any of these products will receive market acceptance or generate significant revenues. 4 6. International Sales. In the years ended December 31, 1993, 1994, 1995, ------------------- 1996, 1997 and 1998, approximately 30%, 57%, 70%, 47%, 73% and 41%, respectively, of the Company's sales were export sales, of which approximately 100%, 85%, 72%, 80%, 93% and 66%, respectively, were sales to Europe. To the extent that international sales continue to make a substantial contribution to Company revenues, currency fluctuations could make the Company's products less competitive in foreign markets, contribute to fluctuations in the Company's operating results and, if the Company makes sales denominated in foreign currencies or maintains significant net assets or liabilities denominated in foreign currencies, expose the Company to currency exchange valuation risks. Political instability, longer receivable collection periods and difficulty in collecting accounts receivable also pose risks to international sales. Moreover, the laws of certain countries, or the enforcement thereof, may not protect the Company's products, intellectual property rights or contractual rights to the same extent as the laws of the United States. There can be no assurance that these factors will not have a material adverse effect on the Company's business and financial condition and results of operations. 7. Product Liability Risk; Limited Insurance Coverage. The manufacture and -------------------------------------------------- sale of the Company's laser-based systems entail significant risk of product liability claims in the event that the use of such systems is alleged to have caused adverse effects on a patient. Although the Company has taken and will continue to take what it believes are appropriate precautions, including maintaining general liability and commercial liability insurance policies which include coverage for product liability claims, there can be no assurance that the Company's insurance coverage limits are or will be adequate to protect the Company from any liabilities it might incur in connection with the sale of its products. The Company currently maintains product liability insurance in the amount of $6,000,000 for any single event or $7,000,000 in the aggregate domestically. In the future, product liability insurance or such increased coverage as the Company may desire may not be available on acceptable terms or on any basis whatsoever. A product liability claim or series of claims successfully asserted against the Company in excess of its insurance coverage could have a material adverse effect on the Company's business and financial condition and results of operations. Additionally, it is possible that adverse product liability actions could negatively affect the Company's ability to obtain and maintain regulatory approval for its products, as well as damage the Company's reputation in any or all markets in which it participates. 8. Competition; Possible Technological Obsolescence. Development by others ------------------------------------------------ of new or improved products, processes, or technologies may make the Company's products obsolete or less competitive. In the past, technological change has not had a material impact on the Company. The ability of the Company to compete is dependent on the Company's ability regularly to enhance and improve its products and successfully develop and market new products. Many of the Company's competitors have greater, and in some cases much greater, financial, managerial, marketing, and technical resources than the Company. There can be no assurance that the Company will successfully differentiate itself from its competitors, that the market will consider the Company's products to be superior to its competitors' products, that the Company's competitors will not develop new or enhanced products that are more effective than the products which have been or may be developed by the Company, or that the Company will be able to adapt to evolving markets and technologies, develop new products, or achieve and, if achieved, maintain technological advantages. 9. Patents and Proprietary Rights; Proprietary Technology. The Company ------------------------------------------------------ relies, to a significant extent, on patents, trade secrets and confidentiality agreements to protect its proprietary technology. There can be no assurance as to the breadth or degree of protection which existing or future patents, if any, may afford the Company, that such patents will not be circumvented or invalidated, or that the Company's products do not and will not infringe on patents or violate proprietary rights of others. If a patent infringement claim is asserted against the Company, or if the Company is required to enforce its rights under an issued patent, the cost of such actions may be very high, whether or not the Company is successful. While the Company is unable to predict what such costs would be if it is obligated to pursue patent litigation, its ability to fund its operations and to pursue its business goals may be adversely affected. 10. Government Regulation. The Company's products are subject to --------------------- significant government regulation in the United States and other countries. To clinically test, manufacture, and market products for human diagnostic and therapeutic use, the Company must comply with mandatory regulations and safety standards established by the FDA and comparable state and foreign regulatory agencies. Typically, products must meet regulatory standards as safe and effective for their intended use prior to being marketed for human applications. The clearance process is expensive and time-consuming, and no assurance can be given that any agency will grant additional clearance for the sale of the Company's products for routine clinical applications, that the length of time the process will require will not be extensive, or that the cost of the process will not be substantial. The FDA also imposes requirements on manufacturers and sellers of products under its jurisdiction, such as those relating to labeling, manufacturing practices, record keeping, and reporting. The FDA also may require post- marketing practices, record keeping and reporting requirements. The following table sets forth the status of FDA clearance of the Company's principal products:
Product Market Date Cleared Status - ------- ------ ------------ ------ Millennium(TM) Dental 10/8/98 Cleared to market DermaLase(TM) Dermatology, General Surgery 7/18/97 Cleared to market LazerSmile(TM) Tooth Whitening N/A Clearance not required CanalFinder(TM) Endodontic Instrumentation N/A Clearance not required FlavorFlow(TM) Dental Fluid Conditioning N/A Not yet submitted
There can be no assurance that additional approvals from the FDA will be granted, that the process to obtain such approvals will not be expensive or lengthy, or that the Company will have sufficient funds to pursue such approvals. The failure to receive requisite approvals for the Company's products or processes, when and if developed, or significant delays in obtaining such additional approvals, could prevent the Company from commercializing its products as anticipated, and could have a material adverse effect on the financial condition, results of operations, cash flows and prospects of the Company. The Company is also subject to regulation under the Radiation Control for Safety and Health Act of 1968 (the "Safety Act") administered by the Center for Devices and Radiological Health ("CDRH") of the FDA. The CDRH controls energy emissions of light and sound and electronic waves from electronic products. These regulations require a laser manufacturer to file new product and annual reports, to maintain quality control, product testing and sales records, to distribute appropriate operation manuals, to incorporate certain design and operating features in lasers sold to end-users and to certify and label each laser sold to end-users as belonging to one of four classes of lasers (based on the level of 5 radiation from the laser). In addition, various warning labels must be affixed to the product and certain protective devices must be installed, depending on the class of product. Under the Safety Act, the Company is also required to register with the FDA as a medical device manufacturer and is subject to inspection on a routine basis by the FDA for compliance with Good Manufacturing Practice ("GMP") regulations. The GMP regulations impose certain procedural and documentation requirements upon the Company relevant to its manufacturing, testing and quality control activities. The CDRH is empowered to seek remedies for violations of these regulatory requirements under the Federal Food, Drug and Cosmetic Act. Various state dental boards are considering the adoption of restrictions on the use of lasers by dental hygienists. In addition, dental boards in a number of states are considering educational requirements regarding use of dental lasers. While the scope of these restrictions and educational requirements is not now known, they could have an adverse effect on sales of the Company's laser-based products. The Company has not filed applications for regulatory approval with the Japanese Ministry of Health and Welfare for any of its products, but is gathering clinical data in preparation for said application for the Millennium(TM) system. The FDA and other governmental agencies, both in the United States and in foreign countries, may adopt additional rules and regulations that may affect the Company's ability to develop and market its products. 11. Dependence on Suppliers. The Company has identified alternate suppliers ----------------------- for most of the components of its laser-based products. There are certain key components for which there are single suppliers. The Company is diligently searching for alternative sources for these suppliers. A change in the suppliers of certain system components, however, would require new regulatory approvals and, in particular, could require an amendment to the "CE" mark granted to the Company pursuant to the European Community's Medical Device Directive, which would hamper the Company's ability to distribute its systems in the European countries requiring such an approval. During the three-month period ended June 30, 1999, the Company experienced reductions in product shipment due principally to problems associated with certain supplier component changes and deficiencies. See "Risk Factors - 5. Uncertainty of Product and Market Acceptance". These supplier related component changes and deficiencies required the Company to redesign certain subassemblies to accommodate available components. There can be no assurance that the Company will not encounter similar component related problems in the future or that the level of sales presently experienced will increase or be sustained in the future. Should the Company experience future componentry problems or should sales diminish in future periods, the Company's operations and working capital position would be adversely affected. 12. Possible Volatility of Common Stock Price; Limited Public Market; ----------------------------------------------------------------- Compliance With Nasdaq Listing Requirements. The Company's Common Stock has been - ------------------------------------------- listed on The Nasdaq SmallCap Market since November 12, 1992, and the Company has no present plans to apply to list the Common Stock on any other domestic securities exchange. In April 1997, the Company's Common Stock was also listed on the Berlin Stock Exchange under the symbol BLA. The market prices for securities of emerging companies, including the Company, have historically been highly volatile. Significant volatility in the market price of shares of Common Stock may arise due to factors such as the Company's developing business, historic losses and relatively low price per share. In addition, future announcements concerning the Company or its competitors may have a significant impact on the market price of the Common Stock. Such announcements might include financial results, the results of testing, technological innovations, new commercial products, changes to government regulations, government decisions on commercialization of products, developments concerning proprietary rights, litigation or public concern as to safety of the Company's products. As long as there is only a limited public market for the Common Stock, the sale of a significant number of shares of Common Stock at any particular time could be difficult to achieve at the market prices prevailing immediately before such shares are offered, and the offering of a significant number of shares of Common Stock at one time could cause a severe decline in the price of the Common Stock. For continued inclusion on The Nasdaq SmallCap Market, an issuer must maintain (i) net tangible assets (total assets less the sum of total liabilities and goodwill) of at least $2,000,000, (ii) net income of no less than $500,000 in the most recent fiscal year or in two of the three most recent fiscal years, or (iii) market capitalization of at least $35,000,000, in addition to a minimum bid price of $1 per share, a market value of the public float of at least $1,000,000, a public float of at least 500,000 shares, at least two market makers, and a minimum of 300 holders of 100 or more shares. At June 30, 1999, the Company met all of the above criteria except for the alternative net income criterion. If the Company continues to suffer significant losses from operations without additional equity financing, it may not be able to meet the requirements for the continued listing of Common Stock on The Nasdaq SmallCap Market, in which case the Common Stock may be delisted from trading on The Nasdaq SmallCap Market. If the Common Stock were excluded from quotation and trading on The Nasdaq SmallCap Market, it would likely trade on the over-the-counter market, in what is commonly referred to as the "Electronic Bulletin Board" or "pink sheets". Should that occur, holders of Common Stock may find it more difficult to dispose of, or to obtain accurate quotations for the market price of, Common Stock. In addition, if the Common Stock is not quoted on The Nasdaq SmallCap Market, it may be subject to a rule that imposes restrictive sales practice requirements on broker-dealers selling such securities to persons other than established customers and accredited investors. For transactions covered by this rule, the broker-dealer must, among other requirements, make a special suitability determination regarding the purchaser and must receive the purchaser's written consent to the transaction prior to any purchase. Consequently, the rule may restrict the ability of broker-dealers to sell or limit the interest of broker- dealers in selling Common Stock and may adversely affect the ability of holders of Common Stock to sell shares. The exclusion of a security from continued quotation on The Nasdaq SmallCap Market may also cause a decline in share price, a diminution of news coverage of the Company, and greater difficulty in arranging future financing. 13. Reliance Upon Key Employees; Additional Personnel. The success of the ------------------------------------------------- Company is substantially dependent on the efforts of certain key personnel of the Company: Jeffrey W. Jones, Keith G. Bateman and Ioana Riziou. The Company does not presently have employment contracts with any of its key 6 personnel, other than Mssrs. Jones and Bateman. The loss of such key personnel could adversely affect the Company's business and prospects. In such event, there can be no assurance that the Company would be able to employ qualified replacements on terms favorable to the Company. The Company presently employs approximately 62 people. If and when the scale of the Company's operations increases, the Company will be required to increase the number of employees, including the number of management personnel. No assurance can be given that the Company will be able to attract and retain additional personnel, and particularly management personnel, having the capabilities that the Company will seek. In seeking qualified personnel, the Company will be required to compete with companies having greater financial and other resources than the Company has. As some of its products are developed, the Company will have to attract additional marketing, manufacturing, technical, scientific and administrative personnel. Since the future success of the Company is, to a significant degree, dependent upon its ability to attract and retain qualified personnel, the Company's inability or failure to attract and retain such personnel could have a materially adverse impact on the business of the Company. 14. No Dividends on Common Stock. The Company has not paid any cash ---------------------------- dividends on its Common Stock since its incorporation, and the Board of Directors does not anticipate declaring any cash dividends on Common Stock in the foreseeable future. The Company currently intends to utilize any earnings it may achieve for reinvestment in its business. Future dividend policy will also depend on the Company's earnings, capital requirements, financial condition, debt covenants, and other factors considered relevant by the Company's Board of Directors. It is unlikely that any dividends on Common Stock will be declared by the Company in the foreseeable future. 15. Possible Issuance of Additional Shares. The Company is authorized to -------------------------------------- issue 50,000,000 shares of Common Stock, of which 17,728,215 shares were issued and outstanding as of August 23, 1999. As of that date, 4,387,191 shares of Common Stock had been reserved for future issuance upon exercise of outstanding options and warrants, and an additional 635,899 shares have been reserved for possible issuance pursuant to the Company's stock option and stock compensation plans. Further, the Company has authorized 1,000,000 shares of preferred stock, $.001 par value per share (the "Preferred Stock"), of which 100 shares had been designated and issued as Series A 6% Redeemable Cumulative Convertible Preferred Stock and 500,000 shares have been designated as Series B Junior Participating Cumulative Preferred Stock. No shares of Preferred Stock are currently outstanding. The Company's Board of Directors has authority to issue Preferred Stock in one or more series and to fix the rights, privileges, restrictions and preferences thereof. Accordingly, the Company may issue one or more series of Preferred Stock in the future that will have preference over the Common Stock with respect to the payment of dividends and upon its liquidation, dissolution, or winding up or have voting or conversion rights which could adversely effect the voting power and percentage ownership of the holders of the Common Stock. Although it has no present commitments to do so (except as noted above), the Company may seek significant additional capital resources and may issue additional shares of Common Stock, additional shares of Preferred Stock and other securities in the future. Such issuances could have anti-takeover and dilutive effects. 16. Broad Discretion in Use of Proceeds. As set forth in "Use of ----------------------------------- Proceeds", with possible usage including the net proceeds from the exercise of Warrants have not been allocated to specific purposes, but rather will be applied to general working capital, the refinement and improvement of existing products, and the development of products currently under development and products the Company may develop in the future. Management will have considerable discretion in applying such proceeds. 17. Stockholder Rights Plan. The Company has adopted a Stockholder Rights ----------------------- Plan. The Plan provides that in the event any person becomes the beneficial owner of 15% or more of the outstanding shares of the Company's Common Stock, each right (a "Right") (other than a Right held by the 15% stockholder and its associates) will be exercisable, on and after the close of business on the tenth business day following such event, to purchase the Company's Common Stock having a market value equal to two times the then current exercise price of the Rights (initially $30.00). The Plan further provides that if, on or after the occurrence of such event, the Company is merged into any other corporation or 50% or more of the Company's assets or earning power are sold, each Right (other than a Right held by the 15% stockholder and its associates) will be exercisable to purchase common shares of the acquiring corporation having a market value equal to two times the then current exercise price of the Rights. The Rights expire on December 31, 2008 (unless previously triggered) and are subject to redemption by the Board of Directors at $.001 per right at any time prior to the first date upon which they become exercisable to purchase shares of Common Stock. The Plan could make it more difficult for a third party to acquire, or discourage a third party from acquiring, control of the Company, and could also limit the price that some investors might be willing to pay in the future for shares of the Company's Common Stock. 18. Year 2000 Issues. The Company is presently continuing its analysis of ---------------- its computer software and hardware requirements with respect to Year 2000 issues, and is attempting to gain additional information regarding the Year 2000 compliance status of its principal suppliers of goods and services and of its principal customers. See "Management's Discussion and Analysis of Financial Condition and Results of Operations" in the Company's Form 10-Q for the quarter ended June 30, 1999. The failure of the Company or any of its principal suppliers and customers to become Year 2000 compliant in a timely manner and the failure to establish alternate communications channels could have a material adverse effect on the Company's business, financial condition, results of operations and cash flow. 19. Forward-Looking Statements. The forward looking statements contained -------------------------- or incorporated by reference in this Prospectus are subject to various risks, uncertainties and other factors that could cause actual results to differ materially from the results anticipated in such forward looking statements. Included among the important risks, uncertainties and other factors are those hereinafter discussed. Few of the forward looking statements in this Prospectus deal with matters that are within the unilateral control of the Company. There is substantial government regulation of the manufacture and sale of medical products, including many of the Company's products, by governmental agencies in both the United States and foreign countries. These governmental agencies often have considerable discretion in determining whether and when to approve the marketing of the Company's products that have not yet received such approval. The availability of equity and debt financing to the Company is affected by, among other things, domestic and world economic conditions and the competition for funds. Rising interest rates might affect the feasibility of debt financing that is offered. Potential investors and lenders will be influenced by their evaluations of the Company and its products and comparisons with alternative investment opportunities. The Company's products do not provide the exclusive means for accomplishing an objective, and customers may choose alternative means. Many of the Company's competitors have much greater financial resources and technical capabilities than does the 7 Company, which may enable such competitors to design and produce superior products or to market their products in a manner that achieves commercial success even in the face of technical superiority on the part of the Company's products. The Company's patents may not offer effective protection against competitors. Competitors may be able to design around the Company's patents or employ technologies not covered by such patents. In addition, the Company's patents may be challenged, and even if such patents are upheld, the diversion of financial and human resources associated with patent litigation could adversely affect the Company. The Company may be found to be violating the patents of others and forced to obtain a license under such patents or modify the design of its products. Rapid technological developments are expected to continue in the industries in which the Company competes. The Company may not be able to develop, manufacture and market products which meet changing user requirements or which successfully anticipate or respond to technological changes on a cost-effective and timely manner. While the Company believes that its technology incorporated into its Millennium(TM) surgical tissue cutting system should be effective in a broad range of medical and dental applications, this belief (except with respect to dental hard tissue and certain dermatological applications, for which clinical research has been and is being conducted) is based largely on preliminary in vitro and in vivo research and extrapolation of observations in such clinical research. No assurances can be given that the Company's Millennium(TM) technology will prove to be applicable to, or will find market acceptance in, any medical or dental fields or that the Company will receive clearance from the FDA or other regulatory agencies to market the Millennium(TM) system or other products embodying its HydroKinetic(TM) technology or variations thereof for any additional applications or in any additional jurisdictions. See "Business - The Millennium(TM) System." USE OF PROCEEDS The Company will not receive any portion of the proceeds from the sale of Common Stock to be sold in this Offering. The Company may receive net proceeds of up to $5,512,250 from the exercise of the Warrants; management currently anticipates that any such proceeds will be utilized for working capital and for other general corporate purposes. 8 PRINCIPAL AND SELLING STOCKHOLDERS The following table sets forth certain information with respect to the beneficial ownership of the Common Stock of the Company as of August 23, 1999 (assuming exercise of the Warrants), and as adjusted to reflect the sale of the 4,020,200 shares of Common Stock offered hereby, (i) by all persons known by the Company to beneficially own more than 5% of the outstanding shares, (ii) by each director of the Company, (iii) by the Named Executive Officer; (iv) by all executive officers and directors of the Company as a group, and (v) by the Selling Stockholders. Unless otherwise indicated, the persons listed below have sole voting and investment power with respect to the shares listed across from their names in the table below.
Shares Beneficially Owned Shares to be Sold Shares Beneficially Owned Name of Beneficial Owner Before Offering(1) in This Offering After Offering(1) - ------------------------------------------------------- ------------------------- ----------------- ------------------------- Number Percent Number Number Percent ------------- --------- ----------------- ------------ ---------- Federico Pignatelli(2) 476,250 2.6 - 476,250 2.6 Jeffrey W. Jones(3) 110,000 * - 110,000 * George V. d'Arbeloff(4) 89,017 * - 89,017 * William A. Owens(5) 30,000 * - 30,000 * All executive officers and directors as a group (8 persons)(6) 1,152,917 6.2 - 1,152,917 6.2 Advisor's Capital Investments Inc. dba Perspective Advisory Group(7) 1,512,894 8.4 517,500 995,394 5.6 Brynley B. Archer 15,000 * 15,000 - * Barclay Investments, Inc. 22,250 * 15,000 7,250 * Banca del Gottardo 300,000 1.7 300,000 - * Carol A. Bingle 15,000 * 15,000 - * Robert P. Bingle 41,521 * 15,000 26,521 * Kenneth & Sophie Brown 15,000 * 15,000 - * BSI -- Banca della Svizzera Italiana 601,300 3.4 601,300 - * Buena Vista Market Inc. 99,000 * 99,000 - * CBG Compagnie Bancaire Geneve 75,000 * 75,000 - * Eric Robert & Gail Coble 75,000 * 60,000 15,000 * Corner Bank Ltd. 306,000 * 306,000 - * Corner Bank (Luxembourg) S.A. 165,000 * 165,000 - * Credit Bancorp 15,000 * 15,000 - * Jack & Carolyn DeSantis 15,000 * 15,000 - * Eurocapital Limited 57,500 * 57,500 - * Euromobiliare Asset Management SGR SPA 153,000 * 153,000 - * Fidulex Management Inc. 61,200 * 61,200 - * Lawrence K. Fleischman 5,000 * 5,000 - * Terry A. Fuller, Ph.D. 50,000 * 50,000 - * Alex & Irene Gonik 15,000 * 15,000 - * Gem Holdings Corp. 198,200 1.1 198,200 - * Raymond Halliwell 15,000 * 15,000 - * Kazimierz & Maria Ilnicki 27,799 * 15,000 12,799 * Mary Lee Ingoldsby 45,000 * 45,000 - * Interbanc Mortgage Services, Inc. 105,000 * 105,000 - * Interbanc Mortgage Services, Inc., Profit Sharing Plan and Trust 15,000 * 15,000 - * Lemanik Sicav Active Growth 258,000 1.4 258,000 - * J. Scott Liolos 15,000 * 15,000 - * Edmond O'Donnell 66,182 * 30,000 36,182 * Pac Capital Strategies Limited Partnership 75,000 * 75,000 - * PacVest Associates 91,615 * 22,500 69,115 * Swiss Bank Corporation 423,750 2.4 210,000 213,750 1.2 Trixego SA 153,000 * 153,000 - * Trout Trading Company, Inc. 5,000 * 5,000 - * UT Radiology Inc. Discretionary Plan F.B.O. Charles H. Mandell 150,000 * 150,000 - * Union Bancaire Privee 90,000 * 90,000 - * Wallington Investments Ltd. 535,500 3.0 535,500 - * Jeffrey Warren Wessel 17,500 * 15,000 2,500 * Roger E. Wood 15,000 * 15,000 - *
______________ * Less than one percent. 9 (1) The number of shares beneficially owned by each stockholder is determined under rules promulgated by the Securities and Exchange Commission, and the information is not necessarily indicative of beneficial ownership for any other purpose. Under such rules, beneficial ownership includes any shares as to which the individual has sole or shared voting or investment power and also any shares which the individual has the right to acquire within 60 days after August 23, 1999. The inclusion herein of such shares, however, does not constitute an admission that the named stockholder is a direct or indirect beneficial owner of such shares. Unless otherwise indicated, each person or entity named in the table has sole voting and investment power (or shares such power with his or her spouse) with respect to all shares of Common Stock listed as owned by such person or entity. (2) Includes 258,750 shares of Common Stock issuable pursuant to options exercisable on or within 60 days of August 23, 1999. (3) Includes 110,000 shares of Common Stock issuable pursuant to options exercisable on or within 60 days of August 23, 1999. (4) Includes 70,835 shares of Common Stock issuable pursuant to options and warrants exercisable on or within 60 days of August 23, 1999. (5) Includes 30,000 shares of Common Stock issuable pursuant to options exercisable on or within 60 days of August 23, 1999. (6) Includes 915,835 shares of Common Stock issuable pursuant to options and warrants exercisable on or within 60 days of August 23, 1999. (7) The address of Advisor's Capital Investments, Inc. is 17 Tripp Road, Woodstock, Connecticut 06281. Advisor's Capital Investments, Inc. expressly disclaims beneficial ownership of 1,437,894 of the shares of Common Stock attributed to it in the above table; it does not have sole or shared power or ability to direct the vote of said shares, but does have shared power to dispose or direct the disposition of said shares. PLAN OF DISTRIBUTION The shares of Common Stock subject to this Prospectus may be sold from time to time by the Selling Stockholders or their successors, assigns or transferees in private transactions for their own accounts. The Selling Stockholders may offer and sell the shares from time to time in transactions on The Nasdaq SmallCap Market on terms to be determined at the time of such sales. The Selling Stockholders may also make private transfers directly or through a broker or brokers. Alternatively, the Selling Stockholders may from time to time offer shares of Common Stock offered hereby to or through underwriters, dealers or agents, who may receive consideration in the form of discounts and commissions; such compensation, which may be in excess of normal brokerage commissions, may be paid by the Selling Stockholders and/or purchasers of the shares of Common Stock offered hereby for whom such underwriters, dealers or agents may act. The Selling Stockholders and any dealers or agents that participate in the distribution of the shares of Common Stock offered hereby may be deemed to be "underwriters" within the meaning of Section 2(11) of the Securities Act, and any discounts, commissions or concessions received and any profit realized by them on the resale of shares as principals may be deemed underwriting compensation under the Securities Act. The aggregate proceeds to the Selling Stockholders from sales of the Common Stock offered hereby will be the purchase price of the Common Stock less any brokers' commissions. The Common Stock offered hereby may be sold from time to time in one or more transactions at a fixed price, which may be changed, or at varying prices determined at the time of such sale or at negotiated prices. The Common Stock issuable upon exercise of the Warrants and offered hereby will be issued by the Company in accordance with the respective terms thereof. The Company is contractually obligated to keep this Prospectus current for as long a period as any Warrants remain outstanding and for two years thereafter. The Company may from time to time notify the Selling Stockholders that this Prospectus is not current and that sales of the Common Stock may not occur until the Prospectus is supplemented by sticker or amendment, as appropriate. To the extent required, the specific shares of Common Stock to be sold, the names of the Selling Stockholders, the respective purchase prices and public offering prices, the names of any agent, dealer or underwriter and any applicable commissions 10 or discounts with respect to a particular offer will be set forth in an accompanying Prospectus supplement, or, if appropriate, a post-effective amendment to the Registration Statement of which this Prospectus forms a part. The laws of certain states may require that sale of the shares of Common Stock offered hereby be conducted solely through brokers or dealers registered in those states. In addition, in certain states the shares of Common Stock offered hereby may not be sold unless they have been registered or qualified for sale in the applicable state or an exemption therefrom is available. Under applicable rules and regulations under the Exchange Act, any person engaged in the distribution of the Common Stock offered hereby may not simultaneously engage in market making activities with respect to the Common Stock for a period of one business day prior to the commencement of such distribution. In addition, without limiting the foregoing, the Selling Stockholders will be subject to applicable provisions of the Exchange Act and the rules and regulations thereunder including, without limitation, Regulation M, which provisions may limit the timing of purchases and sales of Common Stock by Selling Stockholders. The Company will pay substantially all the expenses incurred by the Selling Stockholders and the Company incident to this Offering and the sale of the Common Stock offered hereby to the public, but excluding any underwriting discounts, commissions or transfer taxes. The expenses are estimated to be approximately $30,000. The Company has agreed to indemnify the Selling Stockholders against certain liabilities, including liabilities under the Securities Act. LEGAL MATTERS The validity of the Common Stock offered hereby has been passed upon for the Company by Kelly Lytton Mintz & Vann LLP, Los Angeles, California. EXPERTS The Financial Statements as of December 31, 1998 and 1997 and for each of the three years in the period ended December 31, 1998, incorporated in this registration statement by reference, have been so incorporated in reliance on the report (which contains an explanatory paragraph relating to the Company's ability to continue as a going concern as described in Note 2) of PricewaterhouseCoopers LLP, independent accountants, given on the authority of that firm as experts in auditing and accounting. INCORPORATION BY REFERENCE The following documents filed by the Company with the Commission (File No. 0-19627) under Section 13(a) or 15(d) of the Exchange Act are hereby incorporated by reference: (a) The Company's Annual Report on Form 10-K and Form 10-K/A, for the year ended December 31, 1998; (b) The Company's Report on Form 10-Q and 10-Q/A for the quarterly period ended March 31, 1999; (c) The Company's Report of Form 10-Q for the quarterly period ended June 30, 1999; and (d) The section of the Company's Registration Statement on Form S-1, declared effective by the Securities and Exchange Commission on August 6, 1997, entitled "Description of Securities". All documents filed by the Company pursuant to Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act subsequent to the date of this Prospectus and prior to the termination of this Offering shall also be deemed to be incorporated by reference into this Prospectus, and to be a part hereof, from the dates of filing of such documents. Any statement contained herein or in a document all 11 or a portion of which is incorporated or deemed to be incorporated by reference herein shall be deemed to be modified or superseded for purposes of this Prospectus to the extent that a statement contained herein or in any other subsequently filed document that also is or is deemed to be incorporated by reference herein modifies or supersedes such statement. Any such statement so modified or superseded shall not be deemed, except as so modified or superseded, to constitute a part of this Prospectus. The Company will provide without charge to each person to whom this Prospectus is delivered, including any beneficial owner, upon the written or oral request of any such person, a copy of any and all of the foregoing documents which are incorporated herein by reference, other than exhibits to such documents (unless such exhibits are specifically incorporated by reference in such documents). Written requests should be directed to BioLase Technology, Inc., 981 Calle Amanecer, San Clemente, California 92673, Attention: Corporate Secretary. Telephone requests should be directed to (949) 361-1200. 12 ADDITIONAL INFORMATION A registration statement on Form S-3 (the "Registration Statement") relating to the securities offered hereby has been filed by the Company with the Commission. This Prospectus does not contain all of the information set forth in the Registration Statement and the exhibits thereto. Statements contained in this Prospectus as to the contents of any contract or other document referred to are not necessarily complete and in each instance reference is made to the copy of such contract or other document filed as an Exhibit to the Registration Statement, each such statement being qualified in all respects by such reference. For further information with respect to the Company and the Common Stock being offered hereby, reference is made to the Registration Statement and Exhibits. A copy of the Registration Statement may be inspected by anyone without charge at the Commission's principal office located at 450 Fifth Street, N.W., Washington, D.C. 20549, the Pacific Regional Office located at 5670 Wilshire Boulevard, 11th Floor, Los Angeles, California 90036-3648, the New York Regional Office located at 7 World Trade Center, 13th Floor, New York, New York 10048, and the Chicago Regional Office located at Northwestern Atrium Center, 500 West Madison Street, Chicago, Illinois 60661-2511, and copies of all or any part thereof may be obtained from the Public Reference Branch of the Commission upon the payment of certain fees prescribed by the Commission. The Commission also maintains a World Wide Web site on the Internet at http:\\www.sec.gov that contains reports, proxy and information statements and other information regarding registrants, including the Company, that file electronically with the Commission. 13 No dealer, salesperson or any other person has been authorized to give any information or to make any representations not contained in this Prospectus and, if given or made, such information or representations must not be relied upon as having been authorized by the Company or the Selling Stockholders. This Prospectus does not constitute an offer of any securities other than those to which it relates or an offer to sell, or a solicitation of an offer to buy, to any person in any jurisdiction where such an offer or solicitation would be unlawful. Neither the delivery of this Prospectus nor any sale made hereunder shall, under any circumstances, create any implication that the information contained herein is correct as of any time subsequent to the date hereof. ------------- TABLE OF CONTENTS Page ---- Available Information..................................................... 2 Prospectus Summary........................................................ 2 The Company............................................................... 2 The Offering.............................................................. 3 Risk Factors.............................................................. 3 Use of Proceeds........................................................... 8 Principal and Selling Stockholders........................................ 9 Plan of Distribution...................................................... 10 Legal Matters............................................................. 11 Experts................................................................... 11 Incorporation by Reference................................................ 11 Additional Information.................................................... 13
4,020,200 Shares BIOLASE TECHNOLOGY, INC. Common Stock PROSPECTUS September __, 1999 PART II INFORMATION NOT REQUIRED IN PROSPECTUS Item 14. Other Expenses of Issuance and Distribution - ------- ------------------------------------------- Set forth below are the expenses estimated in connection with the issuance and distribution of the Registrant's securities, other than underwriting commissions and discounts. Except for the SEC registration fee, all expenses are estimated. SEC registration fee $ 3,498.98 Printing and engraving expenses 10,000.00 Accounting fees and expenses 12,000.00 Legal fees and expenses 17,000.00 Transfer Agent's fees and expenses 1,000.00 Miscellaneous expenses 2,501.02 ---------- Total $45,000.00 ==========
Item 15. Indemnification of Directors and Officers. - ------- ----------------------------------------- The Certificate of Incorporation and Bylaws of the Registrant indemnify its officers and directors to the fullest extent permitted by Section 145 of the Delaware General Corporation Law and applicable law. Section 145 of the Delaware General Corporation Law makes provision for the indemnification of officers, directors and other corporate agents in terms sufficiently broad to indemnify such persons, under certain circumstances, for liabilities (including reimbursement of expenses incurred) arising under the Securities Act of 1933, as amended (the "Securities Act"). Item 16. Exhibits and Financial Statement Schedules. - ------- ------------------------------------------ (a) Exhibits The following exhibits are being filed with this Registration Statement or are incorporated by reference therein in accordance with the designated footnote references. Exhibit No. Exhibit ---------- ------- 3. Articles of Incorporation and Bylaws 3.1 Restated Certificate of Incorporation, as Amended. (2) 3.2 Amended and Restated Bylaws. (3) 4. Instruments Defining the Rights of Holders, including Indentures 4.3 Certificate of Designations, Preferences and Rights of Series A 6% Redeemable Cumulative Convertible Preferred Stock of BioLase Technology, Inc. (5) 4.4 Form of Participant Stock Purchase Warrant Certificate. (6) 4.5 Form of Agent Stock Purchase Warrant Certificate. (6) 4.6 Rights Agreement dated as of December 31, 1998 between the Company and U.S. Stock Transfer Corporation. (7) 5. Opinions of Counsel 5.1 Opinion of Kelly Lytton Mintz & Vann LLP 10. Material Contracts 10.1 Premises Lease for 981 Calle Amanecer, San Clemente, California. (1) 10.2 1990 Stock Option Plan. (1) 10.9 1992 Stock Option Plan. (1) 10.18 Amended and Restated 1993 Stock Option Plan. (3) 10.18a First Amendment to Amended and Restated 1993 Stock Option Plan. (4) 10.19 Amended and Restated 1993 Stock Compensation Plan. (2) 10.20 Form of Stock Option Agreement under the 1993 Stock Option Plan. (2) 10.26* Distribution Agreement between the Company and Orbis High Tech Dental GmbH. (6) 10.27* Distribution Agreement, dated January 19, 1999, between the Company and Henry Schein, Inc. (8) 10.28 Amended and Restated Employment Agreement, dated December 18, 1998, by and between the Company and Jeffrey W. Jones.** 10.29 Offer of Employment, dated January 8, 1999, from the Company to Keith G. Bateman.** 10.30* Distribution Agreement between the Company and Sweden & Martina SpA. (8) 10.31 Distribution Agreement between the Company and Tactica International, Inc. 21. Subsidiaries (1) 23.1 Consent of PricewaterhouseCoopers LLP 23.3 Consent of Kelly Lytton Mintz & Vann LLP (contained in Exhibit 5.1) - -------------- * Portions of this Agreement have been omitted pursuant to a confidentiality request filed with the Securities and Exchange Commission. ** Previously filed. (1) Filed with the Company's Registration Statement on Form S-1 dated October 9, 1992 and incorporated by reference. (2) Filed with the Company's 1993 Annual Report on Form 10-K dated April 14, 1994 and incorporated by reference. (3) Filed with the Company's 1995 Second Quarter Report on Form 10-QSB dated September 15, 1995 and incorporated by reference. (4) Filed with the Company's 1995 Annual Report on Form 10-KSB dated May 6, 1996 and incorporated by reference. (5) Filed with the Company's 1996 Third Quarter Report on Form 10-QSB dated November 19, 1996 and incorporated by reference. (6) Filed with the Company's 1996 Annual Report on Form 10-KSB dated April 11, 1997 and incorporated by reference. (7) Filed with the Company's Registration Statement on Form 8-A dated December 29, 1998 and incorporated by reference. (8) Filed with the Company's 1998 Annual Report on Form 10-K dated April 15, 1999 and incorporated by reference. Item 17. Undertakings. - ------- ------------ The undersigned Registrant hereby undertakes: (1) To file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement, to include any material information with respect to the plan of distribution not previously disclosed in the registration statement or any material change to such information in the registration statement. (2) That, for the purpose of determining any liability under the Securities Act, each such post-effective amendment shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. II-1 (3) To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering. The undersigned Registrant hereby undertakes that, for purposes of determining any liability under the Securities Act, each filing of the Registrant's annual report pursuant to Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934 (the "Exchange Act") (and, where applicable, each filing of an employee benefit plan's annual report pursuant to Section 15(d) of the Exchange Act) that is incorporated by reference in the registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons of the Registrant pursuant to the Certificate of Incorporation, the Delaware General Corporation Law or otherwise, the Registrant has been informed that in the opinion of the commission such indemnification is against public policy as expressed in the Act, and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than payment by the Registrant of expenses incurred or paid by a director, officer or controlling person of the Registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered hereunder, the Registrant will, unless in the opinion of its counsel the matter has already been settled by controlling precedent, submit to a court of appropriate jurisdiction the question of whether such indemnification by it is against public policy as expressed in the Act, and shall be governed by the final adjudication of such issue. The undersigned Registrant hereby undertakes: (1) That for purposes of determining any liability under the Act, the information omitted from the form of prospectus filed as part of this registration statement in reliance upon Rule 430A and contained in a form of prospectus filed by the Registrant pursuant to Rule 424B(b)(1) or (4) or 497(h) under the Act, as amended, shall be deemed to be part of this registration as of the time it was declared effective. (2) That, for the purpose of determining any liability under the Securities Act of 1933, as amended, each post-effective amendment shall be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. II-2 SIGNATURES Pursuant to the requirements of the Securities Act of 1933, the Registrant certifies that it has reasonable grounds to believe that it meets all of the requirements for filing on Form S-3 and has duly caused this Amendment No. 3 to Registration Statement to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of San Clemente, State of California on the 1st of September, 1999. REGISTRANT: BIOLASE TECHNOLOGY, INC. By: /s/ Jeffrey W. Jones ------------------------------------- Jeffrey W. Jones President and Chief Executive Officer Pursuant to the requirements of the Securities Act of 1933, this Registration Statement has been signed by the following persons in the capacities and on the dates stated.
SIGNATURE TITLE DATE - ------------------------------------------------- ------------------------------------------------- ----------------- /s/ Jeffrey W. Jones President, Chief Executive Officer (Principal September 1, 1999 - ------------------------------------------------ Executive Officer) and a Director Jeffrey W. Jones /s/ Stephen R. Tartamella Vice President, Chief Financial Officer September 1, 1999 - ------------------------------------------------ (Principal Financial and Accounting Officer) and Stephen R. Tartamella Secretary /s/ Federico Pignatelli Chairman of the Board September 1, 1999 - ------------------------------------------------ Federico Pignatelli /s/ George V. d'Arbeloff Director September 1, 1999 - ------------------------------------------------ George V. d'Arbeloff Director - ------------------------------------------------ William A. Owens
II-3 EX-5.1 2 OPINION OF KELLY LYTTON MINTZ & VANN LLP EXHIBIT 5.1 [LETTERHEAD OF KELLY LYTTON MINTZ & VANN LLP] September 1, 1999 BioLase Technology, Inc. 981 Calle Amanecer San Clemente, California 92673 Re: BioLase Technology, Inc. - Registration Statement on Form S-3 ------------------------------------------------------------- Ladies and Gentlemen: We have acted as counsel to BioLase Technology, Inc., a Delaware corporation (the "Company"), in connection with the issuance and sale or proposed issuance and sale by the Company of an aggregate of 4,020,200 shares of its Common Stock, par value $.001 per share (the "Shares"), which have been registered for resale pursuant to the Company's Registration Statement on Form S-3 filed with the Securities and Exchange Commission under the Securities Act of 1933, as amended (the "Act"). For purposes of rendering this opinion, we have made such legal and factual inquiries and examinations, including reviews of the Company's charter documents and the corporate proceedings taken by the Company in connection with the issuance and sale of the Shares, as we deem necessary or appropriate. Based on such inquiries and examinations and relying thereon, we are of the opinion that: 1. The Shares have been duly authorized. 2. Those Shares which are presently outstanding have been legally issued and are fully paid and non-assessable. 3. Those Shares which are not presently outstanding, when and if issued in the manner contemplated in said Registration Statement and in the instruments pursuant to which such Shares are issuable and upon payment therefor in accordance with the terms of such instruments, will be legally issued, fully paid and non-assessable. In rendering this opinion, we have assumed the authenticity, accuracy and completeness of all documents submitted to us as originals, the conformity to originals of all documents submitted to us as copies thereof, and the accuracy of representations made by officers of the Company in certificates delivered to us regarding factual matters. We are licensed to practice law only in the State of California and, except as specifically set forth in this paragraph, render no opinion herein as to matters involving the laws of any jurisdiction other than the State of California and the United States of America. We are generally familiar with the General Corporation Law of the State of Delaware, and this opinion extends to matters governed by the General Corporation Law of the State of Delaware. This opinion is limited to the laws presently in effect and to the facts as they presently exist. We assume no obligation to revise or supplement this opinion should the present laws of the State of California or the United States of America or the General Corporation Law of the State of Delaware be changed by legislative action, judicial decision or otherwise. This opinion is rendered as of the date hereof, and we express no opinion, and expressly disclaim any undertaking or obligation to update this opinion, in respect of changes of circumstances, events or laws subsequent to this date. We consent to this opinion being filed as an exhibit to said Registration Statement and to the reference to this firm under the caption "Legal Matters" in the prospectus constituting a part of said Registration Statement. In giving this consent, we do not admit that we are in the category of persons whose consent is required under Section 7 of the Act or the rules and regulations of the Commission thereunder. Very truly yours, /s/ Kelly Lytton Mintz & Vann LLP ----------------------------------- Kelly Lytton Mintz & Vann LLP EX-10.31 3 DISTRIBUTION AGREEMENT EXHIBIT 10.31 DISTRIBUTION AGREEMENT BioLase Technology, Inc, hereinafter BIOLASE, with its principal place of business 981 Calle Amanecer, San Clemente, CA 92673 and Tactica International, Inc, hereinafter Tactica, with its primary place of business at 350 5th Ave, Suite 7418, New York, NY 10118 together hereinafter the Parties enter into this agreement. The parties agree that this agreement may be replaced with a more complete formal agreement in form and substance mutually acceptable to the parties incorporating the fundamental terms and conditions of this agreement. The Product consists of a tooth brush that utilizes a mono-chromatic, laser, laser-like or intense light source integrated in or in conjunction with a tooth brush, stand alone or in conjunction with a tooth paste or gel. The current version of the Product is referred to by BIOLASE as the LazerSmile Tooth Whitening System. Whereas BIOLASE has spent considerable time, resources and money developing the Product, and thereby retains all rights to the Product and solely owns and retains all rights to several patents, patents pending, trade secrets and trademarks pertaining to the Product in the U.S. and internationally. Whereas Tactica desires to market and sell the Product in the U.S. and internationally and thereby desires to enter into this agreement whereby they obtain the exclusive rights to market and sell the Product per the terms and conditions herein. Tactica agrees that Tactica will not, and will not permit its officers, employees, contractors or affiliates, directly or indirectly to develop, commercialize or exploit the Product or technology on which the Product is based or direct variations of the Product (some form of a tooth brush with a light source, stand alone and/or with a gel) other than pursuant to this agreement, either during the term of this agreement or following termination of this agreement. It is understood by both BIOLASE and Tactica that Tactica may market the Product under a different name (such as LAZERWHITE) and using the IGIA brand. BIOLASE will give Tactica the opportunity for first right of refusal on related and new consumer products including a new children's version of the LazerSmile system that is planned for development. BIOLASE agrees to preserve confidential information received from Tactica which is confidential to Tactica and is not publically known. BIOLASE and Tactica agree to enter confidentiality agreements under which they agree to protect and preserve the proprietary and confidential interests of each other. 1. Tactica agrees to pay BIOLASE a prepayment of future royalties of $100,000: $50,000 of which will be paid immediately upon execution of this document and the remaining $50,000 will be paid to BIOLASE within 60 days of the execution of this document. This agreement will not be in effect until the first payment of $50,000 is received by BIOLASE. The royalty rate for the first 100,000 Products sold and shipped to end-users is $4.50. Thereafter the royalty is $5.00 per unit for each Product sold and shipped to end users. 2. Tactica agrees to pay Biolase royalties on a total annual minimum quota of 500,000 Products. Payments for these royalties must be made to Biolase before the last day of each month for the previous month's sales and paid shipments. If Tactica fails to meet at least 80% of the minimum requirements/royalty payments on 500,000 units (at least 400,000 units), Biolase will have the option of terminating the agreement or revising its exclusivity. Tactica will only be responsible for paying royalties on Products sold and shipped to customers and not on units held in inventory. Tactica agrees to provide BIOLASE with monthly production, inventory, shipping and sales reports. Biolase reserves the right to audit the source documents supporting those reports. 3. Tactica agrees to pay BIOLASE a royalty of $0.40 for every replacement brush and $0.15 for every tube of replacement gel for the Products. Tactica will not be required to pay these separate brush and gel royalties on the two brushes and one tube of gel included in the original Product package. 4. In order for Tactica to have exclusive rights for the Product, Tactica will provide BIOLASE with a guarantee that Tactica will perform the minimum following marketing activities for the Product in the next four months. Tactica will provide BIOLASE with a detailed schedule of the following marketing events upon execution of this document: A. Produce a one half hour infomercial valued at $250,000 B. Produce a two minute commercial valued at $50,000 C. Produce a one minute commercial valued at $25,000 D. Test market the half hour infomercial valued at $200,000 E. Present and place the Product into wholesale distribution In addition to the above marketing, following the initial 120 day period, Tactica will initiate the roll out of a national campaign to include weekly TV media expenditures valued at about $1,000,000 per week, and up to $500,000 in print expenditures per week. The Product will also be marketed to a total of about 28,000 retail doors and catalogs across the U.S. 5. If Tactica does not perform the above marketing events (A-E) per the detailed schedule during the first 120 days of the agreement, BIOLASE will have the option of terminating the agreement or revising its exclusivity. 6. During the initial 120 days, Tactica will purchase the Product from BIOLASE at BIOLASE's cost. Tactica will not pay BIOLASE a royalty on these units purchased directly from BIOLASE not to exceed 120 days. Royalty payments to BIOLASE will commence once Tactica takes over production of the Product. BIOLASE will provide Tactica with documentation confirming the current production cost. During this time period, or until Tactica takes over production responsibility for the Product, Tactica will either pre-pay BIOLASE for all Product ordered or will arrange their own credit terms directly with the vendor, relieving BIOLASE of all responsibility of payment for any Product produced for or sold to Tactica. BIOLASE agrees to turn over the manufacturing molds to Tactica once the units needed by Tactica for the 120 day initial period are produced. This will allow Tactica to begin the process of setting up manufacturing in a more cost effective manner. 7. WARRANTY - Tactica shall be solely responsible for warranties, guarantees and claims made on all Product sold or handled by Tactica. 8. Upon receipt of the initial prepayment of $50,000, and contingent upon the timely receipt of the 2nd payment of $50,000, BIOLASE will grant Tactica worldwide exclusive marketing rights for the Product under the Igia brand for a period of one year from the execution date of this document, with the following exception. BIOLASE will retain the option of marketing the Product in Japan. Additionally, so long as Tactica fulfills its obligations as stipulated in this agreement, BIOLASE will not develop or manufacture a similar product that competes with the Product. 9. BIOLASE will terminate its agreements with Segel Associates and Pulsebeat promptly following execution of this agreement (and receipt of the first payment of $50,000). Tactica agrees that its rights under this agreement are subject to the rights remaining with Segel and Pulsebeat during their termination periods. Tactica will then take over any existing agreements where Pulsebeat has already placed the Product into catalogs and Tactica agrees to honor the termination clauses of these agreements by paying commissions to Pulsebeat as per the post termination agreement for the catalogs already placed. 10. Tactica is solely responsible for all marketing claims made by Tactica concerning the Product. Tactica agrees to indemnify BIOLASE against and to hold it harmless with respect to any and all loss, liability, cost and expenses arising out of Tactica's marketing claims and sales of the Product. Each of the parties will include the other on its product liability insurance during the period in which it has responsibility for manufacturing the Product hereunder. Any Products which are manufactured by Biolase during the initial 120 day period will be covered on BIOLASE's insurance for a period of one year. When Tactica takes over production of the Product, Tactica will indemnify BIOLASE against and hold it harmless with respect to any loss, liability, cost or expenses related to production, marketing and sales of the Product. BIOLASE will indemnify and hold Tactica harmless for product design and regulatory matters, so long as they are controlled by BIOLASE and any marketing claims made do not exceed those specifically approved in writing by BIOLASE executive management. Any time delays caused by regulatory issues will be added to the 12 month TERM of the agreement. 11. In the event this agreement is terminated, given that in such an event BIOLASE will have the option of taking over production, BIOLASE agrees to provide Tactica with Product to fulfill outstanding orders, for a reasonable wrap up period to fulfill outstanding orders on already placed marketing promotions, at a price that will be $10.00 over the cost, so long as amounts due to BIOLASE from Tactica are paid current. 12. Upon termination of this agreement, Tactica will grant BIOLASE the option of taking over production of the Product at no charge including transferring to Biolase any and all tooling, molds, licenses, etc unique to the manufacture of the Product. 13. TERM - the term of the agreement will be for twelve months from the date of execution of this document. This Agreement is valid upon execution by both Parties and receipt by BIOLASE of the stated prepayment of $50,000 and the additional $50,000 in 60 days from Tactica. If Tactica achieves sales of at least 80% of the minimum royalty payments, BIOLASE agrees to extend the TERM an additional 12 months with similar terms and conditions. 14. This agreement shall be governed by and venue shall be the State of California. /s/ PREM RAMCHANDANI June 2, 1999 - --------------------------------------------- Prem Ramchandani, Date COO Tactica International /s/ AVI SIVAN June 2, 1999 - --------------------------------------------- Prem Ramchandani, Date COO Tactica International /s/ JEFFREY W. JONES June 1, 1999 - --------------------------------------------- Jeffrey W. Jones, Date President and CEO, BioLase EX-23.1 4 CONSENT OF PRICEWATERHOUSECOOPERS LLP EXHIBIT 23.1 CONSENT OF INDEPENDENT ACCOUNTANTS We hereby consent to the incorporation by reference in this Registration Statement on Amendment No. 3 to Form S-3 (File No. 333-58329) of our report dated March 16, 1999 relating to the consolidated financial statements and consolidated financial statement schedule, which appears in BioLase Technology Inc.'s Annual Report on Form 10-K and 10-K/A for the year ended December 31, 1998. We also consent to the reference to us under the heading "Experts" in such Registration Statement. /s/ PricewaterhouseCoopers LLP PricewaterhouseCoopers LLP Costa Mesa, California August 30, 1999 -----END PRIVACY-ENHANCED MESSAGE-----