-----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, II2zr1BMQyh6AZc06XXUko7Vx5kzKfcFFX6HWl0ARnZosn4fal8kw0/Ombvii4Wb AIG11+tEVGOpjiwLjMe0/A== 0000891618-96-000881.txt : 19960614 0000891618-96-000881.hdr.sgml : 19960614 ACCESSION NUMBER: 0000891618-96-000881 CONFORMED SUBMISSION TYPE: S-1/A PUBLIC DOCUMENT COUNT: 7 FILED AS OF DATE: 19960613 SROS: NASD FILER: COMPANY DATA: COMPANY CONFORMED NAME: VENTANA MEDICAL SYSTEMS INC CENTRAL INDEX KEY: 0000893160 STANDARD INDUSTRIAL CLASSIFICATION: [] IRS NUMBER: 942976937 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: S-1/A SEC ACT: 1933 Act SEC FILE NUMBER: 333-04461 FILM NUMBER: 96580691 BUSINESS ADDRESS: STREET 1: 3865 N BUSINESS CENTER DRIVE CITY: TUCSON STATE: AZ ZIP: 85705 BUSINESS PHONE: 5208872155 MAIL ADDRESS: STREET 1: 3865 N BUSINESS CENTER DR CITY: TUCSON STATE: AZ ZIP: 85705 S-1/A 1 AMENDMENT NO.1 TO FORM S-1 DATED 6/13/96 1 AS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION ON JUNE 13, 1996 REGISTRATION NO. 333-4461 - -------------------------------------------------------------------------------- - -------------------------------------------------------------------------------- SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 ------------------------ AMENDMENT NO. 1 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ------------------------ VENTANA MEDICAL SYSTEMS, INC. (EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER) ------------------------ DELAWARE 3841 94-2976937 (STATE OR OTHER JURISDICTION OF (PRIMARY STANDARD INDUSTRIAL (I.R.S. EMPLOYER INCORPORATION OR ORGANIZATION) CLASSIFICATION CODE NUMBER) IDENTIFICATION NUMBER)
3865 NORTH BUSINESS CENTER DRIVE TUCSON, ARIZONA 85705 (520) 887-2155 (ADDRESS, INCLUDING ZIP CODE, AND TELEPHONE NUMBER, INCLUDING AREA CODE, OF REGISTRANT'S PRINCIPAL EXECUTIVE OFFICES) R. JAMES DANEHY PRESIDENT AND CHIEF EXECUTIVE OFFICER VENTANA MEDICAL SYSTEMS, INC. 3865 NORTH BUSINESS CENTER DRIVE TUCSON, ARIZONA 85705 (520) 887-2155 (NAME, ADDRESS, INCLUDING ZIP CODE, AND TELEPHONE NUMBER, INCLUDING AREA CODE, OF AGENT FOR SERVICE) ------------------------ COPIES TO: BARRY E. TAYLOR, ESQ. GARY L. SELLERS, ESQ. CHRISTOPHER D. MITCHELL, ESQ. SIMPSON THACHER & BARTLETT TREVOR J. CHAPLICK, ESQ. 425 LEXINGTON AVENUE WILSON SONSINI GOODRICH & ROSATI NEW YORK, NEW YORK 10017-3954 PROFESSIONAL CORPORATION (212) 455-2000 650 PAGE MILL ROAD PALO ALTO, CALIFORNIA 94304-1050 (415) 493-9300
------------------------ APPROXIMATE DATE OF COMMENCEMENT OF PROPOSED SALE TO THE PUBLIC: As soon as practicable after the effective date of this Registration Statement. ------------------------ 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, check the following box. / / If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. / / If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. / / If delivery of the prospectus is expected to be made pursuant to Rule 434, please check the following box. / / ------------------------ THE REGISTRANT HEREBY AMENDS THIS REGISTRATION STATEMENT ON SUCH DATE OR DATES AS MAY BE NECESSARY TO DELAY ITS EFFECTIVE DATE UNTIL THE REGISTRANT SHALL FILE A FURTHER AMENDMENT WHICH SPECIFICALLY STATES THAT THIS REGISTRATION STATEMENT SHALL THEREAFTER BECOME EFFECTIVE IN ACCORDANCE WITH SECTION 8(A) OF THE SECURITIES ACT OF 1933 OR UNTIL THE REGISTRATION STATEMENT SHALL BECOME EFFECTIVE ON SUCH DATE AS THE COMMISSION, ACTING PURSUANT TO SUCH SECTION 8(A), MAY DETERMINE. - -------------------------------------------------------------------------------- - -------------------------------------------------------------------------------- 2 VENTANA MEDICAL SYSTEMS, INC. CROSS-REFERENCE SHEET PURSUANT TO ITEM 501(B) OF REGULATION S-K SHOWING LOCATION IN PROSPECTUS OF PART I ITEMS OF FORM S-1
ITEM NUMBER AND HEADING IN FORM S-1 REGISTRATION STATEMENT LOCATION OF CAPTION IN PROSPECTUS - ------------------------------------------------------- ------------------------------------- 1. Forepart of the Registration Statement and Outside Front Cover Page of Prospectus........... Forepart of Registration Statement; Outside Front Cover Page; Additional Information 2. Inside Front and Outside Back Cover Pages of Prospectus....................................... Inside Front Cover Page; Outside Back Cover Page 3. Summary Information, Risk Factors and Ratio of Earnings to Fixed Charges........................ Prospectus Summary; The Company; Risk Factors 4. Use of Proceeds.................................. Use of Proceeds 5. Determination of Offering Price.................. Outside Front Cover Page; Underwriting 6. Dilution......................................... Dilution; Risk Factors 7. Selling Security Holders......................... Principal and Selling Stockholders 8. Plan of Distribution............................. Outside and Inside Front Cover Pages; Underwriting; Outside Back Cover Page 9. Description of Securities to be Registered....... Prospectus Summary; Dividend Policy; Capitalization; Description of Capital Stock; Shares Eligible for Future Sale 10. Interests of Named Experts and Counsel........... Legal Matters 11. Information with Respect to the Registrant....... Outside and Inside Front Cover Pages; Prospectus Summary; Risk Factors; Use of Proceeds; Dividend Policy; Capitalization; Dilution; Selected Consolidated Financial and Operating Data; Management's Discussion and Analysis of Financial Condition and Results of Operations; Business; Management; Certain Transactions; Principal Stockholders; Description of Capital Stock; Shares Eligible for Future Sale; Financial Statements; Outside Back Cover Page 12. Disclosure of Commission Position on Indemnification for Securities Act Liabilities... Not Applicable
3 INFORMATION CONTAINED HEREIN IS SUBJECT TO COMPLETION OR AMENDMENT. A REGISTRATION STATEMENT RELATING TO THESE SECURITIES HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION. THESE SECURITIES MAY NOT BE SOLD NOR MAY OFFERS TO BUY BE ACCEPTED PRIOR TO THE TIME THE REGISTRATION STATEMENT BECOMES EFFECTIVE. THIS PROSPECTUS SHALL NOT CONSTITUTE AN OFFER TO SELL OR THE SOLICITATION OF AN OFFER TO BUY NOR SHALL THERE BE ANY SALE OF THESE SECURITIES IN ANY STATE IN WHICH SUCH OFFER, SOLICITATION OR SALE WOULD BE UNLAWFUL PRIOR TO REGISTRATION OR QUALIFICATION UNDER THE SECURITIES LAWS OF ANY SUCH STATE. SUBJECT TO COMPLETION, DATED MAY 24, 1996 3,000,000 SHARES LOGO VENTANA MEDICAL SYSTEMS, INC. COMMON STOCK ------------------------------ Of the 3,000,000 shares (the "Shares") of common stock, par value $.001 per share (the "Common Stock"), offered hereby (the "Offering"), 2,200,000 Shares are being sold by Ventana Medical Systems, Inc. ("Ventana" or the "Company") and 800,000 Shares are being sold by certain stockholders of the Company (the "Selling Stockholders"). See "Principal and Selling Stockholders." The Company will not receive any of the proceeds from the sale of Shares by the Selling Stockholders. Prior to the Offering, there has been no public market for the Common Stock of the Company, and no assurance can be given that an active trading market for the Common Stock will develop after the Offering. It is currently estimated that the initial public offering price will be between $14.00 and $16.00 per share. See "Underwriting" for a discussion of the factors to be considered in determining the initial public offering price. ------------------------------ THE COMMON STOCK OFFERED HEREBY INVOLVES A HIGH DEGREE OF RISK. SEE "RISK FACTORS" BEGINNING ON PAGE 7. ------------------------------ THESE SECURITIES HAVE NOT BEEN APPROVED OR DISAPPROVED BY THE SECURITIES AND EXCHANGE COMMISSION OR ANY STATE SECURITIES COMMISSION NOR HAS THE COMMISSION OR ANY STATE SECURITIES COMMISSION PASSED UPON THE ACCURACY OR ADEQUACY OF THIS PROSPECTUS. ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENSE. - ------------------------------------------------------------------------------------------------------- - ------------------------------------------------------------------------------------------------------- UNDERWRITING PROCEEDS TO PRICE TO DISCOUNTS AND PROCEEDS TO SELLING PUBLIC COMMISSIONS(1) COMPANY(2) STOCKHOLDERS - ------------------------------------------------------------------------------------------------------- Per Share.......................... $ $ $ $ - ------------------------------------------------------------------------------------------------------- Total(3)........................... $ $ $ $ - ------------------------------------------------------------------------------------------------------- - -------------------------------------------------------------------------------------------------------
(1) The Company and the Selling Stockholders have agreed to indemnify the Underwriters against certain liabilities, including liabilities arising under the Securities Act of 1933, as amended. See "Underwriting." (2) Before deducting expenses of the Offering payable by the Company, estimated at $925,000. (3) Certain of the Selling Stockholders have granted the Underwriters a 30-day option to purchase up to an additional 450,000 shares of Common Stock on the same terms as the Common Stock offered hereby solely to cover over-allotments, if any (the "Over-Allotment Option"). If the Over-Allotment Option is exercised in full, the total Price to Public, Underwriting Discounts and Commissions and Proceeds to Selling Stockholders will be $ , $ and $ , respectively. See "Underwriting" and "Principal and Selling Stockholders." ------------------------------ The Shares are being offered by the several Underwriters, subject to prior sale, when, as and if delivered and accepted by them, subject to certain conditions, including the approval of certain legal matters by counsel for the Underwriters. The Underwriters reserve the right to withdraw, cancel or modify such offer and to reject orders in whole or in part. It is expected that delivery of the Shares will be made against payment therefor on or about , 1996, at the offices of Bear, Stearns & Co. Inc., 245 Park Avenue, New York, New York 10167. ------------------------------ BEAR, STEARNS & CO. INC. DILLON, READ & CO. INC. , 1996 4 IN CONNECTION WITH THIS OFFERING, THE UNDERWRITERS MAY OVER-ALLOT OR EFFECT TRANSACTIONS WHICH STABILIZE OR MAINTAIN THE MARKET PRICE OF THE COMMON STOCK OF THE COMPANY AT A LEVEL ABOVE THAT WHICH MIGHT OTHERWISE PREVAIL IN THE OPEN MARKET. SUCH TRANSACTIONS MAY BE EFFECTED ON THE NASDAQ NATIONAL MARKET OR OTHERWISE. SUCH STABILIZING, IF COMMENCED, MAY BE DISCONTINUED AT ANY TIME. 2 5 PROSPECTUS SUMMARY The following summary is qualified in its entirety by the more detailed information, including "Risk Factors," and the Consolidated Financial Statements and Notes thereto, appearing elsewhere in this Prospectus. Unless otherwise indicated, all information in this Prospectus (i) assumes no exercise of the Underwriters' Over-Allotment Option, (ii) reflects a 1-for-2.7059046 reverse split of the Common Stock to be effected prior to the closing of this Offering, (iii) reflects the conversion of all outstanding shares of Convertible Redeemable Preferred Stock ("Preferred Stock") into Common Stock and cancellation of accrued dividends upon such conversion, and (iv) assumes the exercise of warrants to purchase 64,244 shares of Common Stock of the Company upon the closing of this Offering, which warrants will terminate if not so exercised. See "Description of Capital Stock" and "Underwriting." The Shares of Common Stock offered hereby are subject to a high degree of risk. See "Risk Factors." This Prospectus contains forward-looking statements that involve risks and uncertainties. The Company's actual results may differ materially from the results discussed in the forward-looking statements. Factors that might cause such differences include, but are not limited to, those discussed in "Risk Factors." THE COMPANY Ventana develops, manufactures and markets proprietary instrument/reagent systems that automate immunohistochemistry ("IHC") and in situ hybridization ("ISH") tests for the analysis of cells and tissues on microscope slides. These tests are important tools used in the diagnosis of and selection of treatment for cancer. With a worldwide installed base of 581 instruments as of March 31, 1996, the Company believes that it is the worldwide leader in the automated IHC testing market. The Company estimates that its installed base is approximately five times as large as the combined installed base of instruments of all of the Company's current competitors. Ventana has placed instruments with 35 of the 42 cancer centers designated by the National Cancer Institute including the Mayo Clinic, the Dana Farber Cancer Institute, The Johns Hopkins University and the M.D. Anderson Cancer Center. Each Ventana proprietary system placed provides a recurring revenue stream as customers consume reagents and supplies sold by the Company with each test conducted. Ventana's "patient priority" systems (the Ventana ES and gen II) perform multiple tests rapidly on a single patient biopsy thereby providing a matrix of diagnostic data to the pathologist. In February 1996, Ventana acquired BioTek Solutions, Inc. ("BioTek") for several strategic reasons. The Company believes the combination of Ventana's "patient priority" systems and BioTek's TechMate "batch processing" systems, which process high volumes of tests on multiple patient biopsies, will enable the Company to serve the full range of health care institutions that perform IHC tests. Ventana increased its installed base of instruments from 294 to 581, as of March 31, 1996, as a result of the acquisition, thereby increasing the corresponding aggregate recurring reagent revenue stream and enabling the Company to become the worldwide leader in automated IHC testing. Ventana believes significant synergies and margin improvements can be realized from the integration of BioTek into Ventana's business model in which important value-added activities are performed internally, in contrast to BioTek's reliance on third parties. Cancer is the second leading cause of death in the United States accounting for 25% of deaths. Currently, approximately 10 million people have a history of invasive cancer. It is estimated that approximately 1.4 million new cases of invasive cancer will be diagnosed each year. The vast majority of IHC testing associated with cancer diagnosis and treatment in the United States is conducted in an aggregate of approximately 2,200 clinical institutions and reference and research laboratories. The Company estimates that these institutions and laboratories create the opportunity for the placement of as many as 2,500 automated IHC testing instruments. The Company believes that less than 20% of such institutions and laboratories currently conduct IHC testing on an automated basis. The international market for instrument placements is estimated by the Company to be approximately 1.2 times the size of the United States market with Europe accounting for approximately 55% of the international market potential. As compared to manual IHC testing, Ventana's automated systems provide improved reliability, reproducibility and consistency of test results. The systems' economic advantages include reduced cost per test, faster turnaround time, increased test throughput and a reduced dependence on skilled laboratory technicians. The Company believes it will play a critical, expanding role in cancer science as researchers will use Ventana systems to accelerate the identification and development of new tests and its installed base of instruments will speed the commercialization and clinical implementation of such new tests. The main element of the Company's strategy to strengthen its leadership position in automated IHC testing is to maximize instrument placements in order to create a barrier that competitors will need to overcome. To meet this objective, the Company plans to introduce two lower priced instruments, one for potential patient priority customers (the Ventana NexES) and one for potential batch processing customers (the TechMate 250). The Company believes that these lower priced instruments will enable it to increase its emphasis on instrument placements through reagent agreement plans ("RAPs"), through which a customer obtains the use of an instrument with no capital investment in exchange for the customers' commitment to purchase reagents from the Company at a higher price than if the instrument had been purchased. The Company believes that it can accelerate the rate of expansion of its installed base of instruments by using RAPs because the required capital investment associated with a purchase, a significant sales hurdle, will be eliminated. 3 6 THE OFFERING Common Stock offered: By the Company.......................... 2,200,000 shares By the Selling Stockholders............. 800,000 shares Total........................... 3,000,000 shares Common Stock to be outstanding after the Offering................................ 10,974,883 shares(1) Use of proceeds........................... For repayment of approximately $15.9 million of indebtedness, capital expenditures, working capital and general corporate purposes. Proposed Nasdaq National Market Symbol.... VMSI
- --------------- (1) Includes 8,710,639 outstanding shares of Common Stock, 64,244 shares of Common Stock issuable upon the exercise of outstanding warrants which would otherwise expire upon the closing of this Offering and the 2,200,000 Shares of Common Stock offered by the Company hereby. Excludes 879,183 shares of Common Stock issuable upon exercise of warrants that may remain outstanding after the completion of this Offering and 840,357 shares of Common Stock issuable upon the exercise of options outstanding under the Company's stock option plans. 4 7 SUMMARY CONSOLIDATED FINANCIAL INFORMATION AND OPERATING DATA (DOLLARS IN THOUSANDS, EXCEPT PER SHARE DATA)
ACTUAL ------------------------------------------------ PRO FORMA(1) --------------------------------------- THREE MONTHS THREE MONTHS YEAR ENDED DECEMBER 31, ENDED MARCH 31, YEAR ENDED ENDED MARCH 31, DECEMBER 31, --------------------------- ------------------ ------------------- ----------------- 1993 1994 1995 1995 1996 1994 1995 1995 1996 ------- ------- ------- ------- -------- -------- -------- ------- ------- STATEMENT OF OPERATIONS DATA: Sales: Instruments....................... $ 1,162 $ 2,588 $ 4,644 $ 1,007 $ 1,594 $ 5,798 $ 8,396 $ 2,040 $ 1,733 Reagents and others............... 1,519 3,339 5,969 1,195 2,552 6,647 11,079 2,378 3,495 ------- ------- ------- ------- ------- ------- ------- ------- ------- Total net sales................. 2,681 5,927 10,613 2,202 4,146 12,445 19,475 4,418 5,228 Cost of goods sold................. 1,722 2,531 4,282 936 1,435 5,883 9,096 2,134 1,927 ------- ------- ------- ------- ------- ------- ------- ------- ------- Gross profit....................... 959 3,396 6,331 1,266 2,711 6,562 10,379 2,284 3,301 Operating expenses: Research and development.......... 2,100 1,926 2,239 556 613 2,687 4,407 721 771 Selling, general and administrative.................. 4,067 6,899 7,435 1,594 2,279 9,942 10,968 2,367 2,704 ------- ------- ------- ------- ------- ------- ------- ------- ------- Loss from operations before nonrecurring expenses and amortization of intangibles....... (5,208) (5,429) (3,343) (884) (181) (6,067) (4,996) (804) (174) Nonrecurring expenses.............. -- -- -- -- (7,083) (8,373) -- -- -- Amortization of intangibles........ -- -- -- -- -- (1,344) (1,344) (336) (336) ------- ------- ------- ------- ------- ------- ------- ------- ------- Loss from operations............... (5,208) (5,429) (3,343) (884) (7,264) (15,784) (6,340) (1,140) (510) Interest income (expense).......... 229 59 74 50 (5) 59 74 50 (5) ------- ------- ------- ------- ------- ------- ------- ------- ------- Net loss........................... $(4,979) $(5,370) $(3,269) $ (834) $ (7,269) $(15,725) $ (6,266) $(1,090) $ (515) ======= ======= ======= ======= ======= ======= ======= ======= ======= Net loss per share, as adjusted(2)....................... $ (0.39) $ (0.10) $ (0.85) $ (0.66) $ (0.12) $ (0.05) ======= ======= ======= ======= ======= ======= Shares used in computing net loss per share, as adjusted(2)......... 8,354 8,220 8,585 9,466 9,331 9,696 ======= ======= ======= ======= ======= =======
MARCH 31, 1996 -------------------------- ACTUAL AS ADJUSTED(3) ------- -------------- BALANCE SHEET DATA: Cash and cash equivalents.............................................................. $ 3,436 $ 18,413 Long-term debt......................................................................... 15,035 -- Working capital........................................................................ 1,195 16,172 Total assets........................................................................... 24,752 39,729 Accumulated deficit(4)................................................................. (29,398) (29,398) Total stockholders' equity(4).......................................................... 1,475 31,487
SELECTED OPERATING DATA: The following table sets forth the Company's pro forma annual instrument placements and instrument installed base for the periods indicated as if the acquisition of BioTek had taken place on January 1, 1992:
THREE MONTHS YEAR ENDED DECEMBER 31, ENDED ---------------------------- MARCH 31, 1992 1993 1994 1995 1996 ---- ---- ---- ---- ------------ INSTRUMENT PLACEMENTS (UNITS): Patient priority (Ventana)............................................. 17 56 74 113 33 Batch processing (BioTek).............................................. 4 37 106 128 12 -- -- --- --- --- Total annual placements.............................................. 21 93 180 241 45 == == === === === Total instrument installed base.................................... 22 115 295 536 581 == == === === === RAPs in installed base............................................. 6 25 44 66 72 == == === === ===
- --------------- (1) Adjusted to reflect the acquisition of BioTek as of January 1, 1994. BioTek was acquired February 26, 1996. (2) See Note 1 to Consolidated Financial Statements and Note 8 to the Unaudited Pro Forma Condensed Consolidated Financial Statements for information concerning the computation of net loss per share. (3) Adjusted to give effect to the receipt of the net proceeds from the sale of the Shares of Common Stock offered by the Company hereby and the application thereof (at an assumed initial public offering price of $15.00 per share). See "Use of Proceeds" and "Capitalization." (4) Actual amounts reflect the assumed conversion of the Preferred Stock but not the exercise of warrants which would otherwise expire upon the closing of this Offering. 5 8 RISK FACTORS In addition to the other information in this Prospectus, the following risk factors should be considered carefully in evaluating the Company and its business before purchasing the Shares of Common Stock offered hereby. This Prospectus contains forward-looking statements which involve risks and uncertainties. The Company's actual results may differ materially from those anticipated by the forward-looking statements as a result of certain factors, including those set forth in Risk Factors and elsewhere in this Prospectus. Continuing Losses; Uncertainty of Future Profitability. The Company has incurred cumulative losses of $29.4 million from its inception in 1985 through March 31, 1996. In February 1996, the Company acquired BioTek, which had sustained cumulative losses of $17.7 million since its inception in October 1990. The Company intends to make increased investments in both product development and sales and marketing and expects to incur operating losses through at least the first half of 1997. The Company's ability to achieve profitability is dependent on a variety of factors including the extent to which its instrument and reagent systems continue to achieve market acceptance, the Company's ability to compete successfully, the Company's ability to develop, introduce, market and distribute existing and new diagnostic systems, the Company's ability to expand manufacturing capacity as required, the successful integration of BioTek's operations and the receipt of required regulatory approvals for products developed by the Company. There can be no assurance that the Company will be successful in these efforts. Moreover, if profitability is achieved, the level of profitability cannot be accurately predicted and there can be no assurance that any such profitablity will be sustained. See "Management's Discussion and Analysis of Financial Condition and Results of Operations" and "Business." Future Fluctuations in Operating Results. The Company derives revenues from the sale of reagents and instruments. The initial placement of an instrument is subject to a longer, less consistent sales cycle than the sale of reagents, which begin and are recurring once an instrument is placed. Consequently, the Company's future operating results are likely to fluctuate substantially from period to period because instrument sales are likely to remain an important part of revenues in the near future. The degree of fluctuation will depend on the timing, level and mix of instruments placed through direct sales and instruments placed through RAPs. In addition, average daily reagent use by customers may fluctuate from period to period, which may contribute to future fluctuations in revenues. Other factors that may result in fluctuations in operating results include the timing of new product announcements and the introduction of new products and new technologies by the Company and its competitors, market acceptance of the Company's current or new products, developments with respect to regulatory matters, availability and cost of raw materials from its suppliers, competitive pricing pressures, increased research and development expenses, and increased marketing and sales expenses associated with the implementation of the Company's market expansion strategies for its instrument and reagent products. In addition, a significant portion of the Company's expense levels are based on its expectation of a higher level of revenues in the future and are relatively fixed in nature. Therefore, if revenue levels are below expectations, operating results in a given period are likely to be adversely affected. See "Management's Discussion and Analysis of Financial Condition and Results of Operations." Rate of Market Acceptance and Technological Change. Use of automated systems to perform diagnostic tests is relatively new. Historically, the diagnostic tests performed by the Company's systems have been performed manually by laboratory personnel. The rate of market acceptance of the Company's products will be largely dependent on the Company's ability to persuade the medical community of the benefits of automated diagnostic testing using the Company's products. Market acceptance and sales of the Company's products may also be affected by the price and quality of the Company's products. The Company's products could also be rendered obsolete or noncompetitive by virtue of technological innovations in the field of molecular diagnostics. Failure of the Company's products to achieve market acceptance would have a material adverse effect on the Company's business, financial condition and results of operations. See "Business." Risks Associated with Development and Introduction of New Products. The Company's future growth and profitability will be dependent, in large part, on its ability to develop, introduce and market new instruments and reagents used in the diagnosis of cancer and additional disease states. In particular, the Company must successfully and timely introduce the NexES and TechMate 250. These instruments are 6 9 smaller capacity, lower priced instruments than the Company's current instruments and are necessary to expand the market opportunity at smaller hospitals and reference laboratories in the United States and Europe. The Company depends in part on the success of medical research in developing new antibodies, nucleic acid probes and clinical diagnostic procedures that can be adapted for use in the Company's systems. In addition, the Company will need to obtain licenses on satisfactory terms to certain of these technologies, as to which there is no assurance. Certain of the Company's products are currently under development, initial testing or preclinical or clinical evaluation by the Company. Other products are scheduled for future development. Products under development or scheduled for future development may prove to be unreliable from a diagnostic standpoint, may be difficult to manufacture in an efficient manner, may fail to receive necessary regulatory clearances, may not achieve widespread market acceptance or may encounter other unanticipated difficulties. The failure of the Company to develop, introduce and market new products on a timely basis or at all could have a material adverse effect on the Company's business, financial condition and results of operations. See "Business -- Research and Development." Competition. Competition in the diagnostic industry is intense and is expected to increase. The Company's systems compete both with products manufactured by competitors and with traditional manual diagnostic procedures. The Company's competitors may succeed in developing products that are more reliable or effective or less costly than those developed by the Company and may be more successful than the Company in manufacturing and marketing their products. Although the Company plans to continue to work to develop new and improved products, there are other companies engaged in research and development of diagnostic devices or reagents, and the introduction of such devices or alternative methods for diagnostic testing could hinder the Company's ability to compete effectively and could have a material adverse effect on the Company's business, financial condition and results of operations. Many of the companies selling or developing diagnostic devices, instruments, reagents and genetic probe tests have financial, manufacturing, marketing and distribution resources significantly greater than those of Ventana. In addition, many of these competitors have long-term supplier relationships with Ventana's existing and potential customers. The Company's patient priority instruments require the use of the Company's detection chemistries but can be used with primary antibodies supplied by third parties, and the Company's batch processing instruments can be used with both detection chemistries and primary antibodies supplied by third parties. Accordingly, the Company encounters significant competition in the sale of reagents for use on its instruments that can be used with reagents supplied by third parties. See "Business -- Competition." Manufacturing Risks and Dependence on Key Suppliers; Third-Party Manufacturers. The Company has only manufactured patient priority instruments and reagents for commercial sale since late 1991, and manufacturing of the Company's batch processing instruments is performed by third parties. As the Company continues to increase production of such instruments and reagents and develops and introduces new products, it may from time to time experience difficulties in manufacturing. BioTek currently manufactures reagents in its Santa Barbara, California facility and Ventana manufactures reagents in its Tucson, Arizona facilities. The Company expects to complete, in September 1996, the consolidation of reagent manufacturing in its Tucson facilities. Difficulties or delays in integrating reagent manufacturing could result in the inability to achieve anticipated cost reductions and could have a material adverse effect on the Company's business, financial condition and results of operations. Ventana must increase production volumes of instruments and reagents in a cost-effective manner in order to be profitable. To increase production levels, the Company will need to scale-up its manufacturing facilities, increase its automated manufacturing capabilities and continue to comply with the current good manufacturing practices ("GMPs") prescribed by the United States Food and Drug Administration ("FDA") and other standards prescribed by various federal, state and local regulatory agencies in the United States and other countries, including the International Standards Organization ("ISO") 9000 Series certifications. There can be no assurance that manufacturing and quality problems will not arise as the Company increases its manufacturing operations or that such scale-up can be achieved in a timely manner or at a commercially reasonable cost. Manufacturing or quality problems or difficulties or delays in manufacturing scale-up could have a material adverse effect on the Company's business, financial condition and results of operations. 7 10 The Company's reagent products are formulated from both chemical and biological materials utilizing proprietary Ventana technology as well as standard processing techniques. Certain components and raw materials, primarily antibodies, used in the manufacturing of the Company's reagent products are currently provided by single-source vendors. There can be no assurance that the materials or reagents needed by the Company will be available in commercial quantities or at acceptable prices. Any supply interruption or yield problems encountered in the use of materials from these vendors could have a material adverse effect on the Company's ability to manufacture its products until a new source of supply is obtained. The use of alternative or additional suppliers could be time consuming and expensive. In addition, a number of the components used to manufacture the ES and gen II instruments are fabricated on a custom basis to the Company's specifications and are currently available from a limited number of sources. Consequently, in the event the supply of materials or components from these vendors were delayed or interrupted for any reason or in the event of quality or reliability problems with such components or suppliers, the Company's ability to supply such instruments could be impaired, which could have a material adverse effect on the Company's business, financial condition and results of operations. See "Business -- Manufacturing." The Company relies on two outside parties to manufacture its batch processing instruments. Kollsman Manufacturing Company, Inc. ("Kollsman") currently manufactures the TechMate 500 instrument and the Company is in the process of negotiating a contract with Kollsman for the continued manufacture of such instrument. The Company has entered into a contract manufacturing agreement with LJL BioSystems, Inc. ("LJL") for the manufacture of the TechMate 250 instrument. There can be no assurance that these manufacturers will be able to meet the Company's product needs in a satisfactory, cost effective and timely manner. The Company's reliance on third-party manufacturers involves a number of additional risks, including the absence of guaranteed capacity, and reduced control over delivery schedules, quality assurance and costs. Although the Company believes that these manufacturers have an economic incentive to perform such manufacturing for the Company, the amount and timing of resources to be devoted to these activities by such manufacturers are not within the control of the Company, and there can be no assurance that manufacturing problems will not occur in the future. Any such manufacturing or supply problems could have a material adverse effect on the Company's business, financial condition and results of operations. Dependence on Distributors. The Company's patient priority systems and reagents are sold directly by Company personnel to end-users in North America and internationally. The Company's batch processing instruments and reagents are sold under distribution agreements entered into by BioTek. In the United States, batch processing instruments and reagents are sold through Curtin Matheson Scientific, Inc., a subsidiary of Fischer Scientific, Inc. ("CMS"), under an exclusive agreement that expires in April 1998. In Europe, batch processing instruments are sold through DAKO A/S ("DAKO") which also pays BioTek a fixed dollar royalty for each instrument in service in exchange for the right to sell its own reagents for use with such systems. The agreement with DAKO provides DAKO with exclusive distribution rights for batch processing instruments in Europe and other territories, subject to certain performance requirements. The agreement expires in December 1999. Accordingly, the Company is likely to be dependent upon DAKO for international sales of batch processing instruments through this date. United States sales through CMS are subject to several operating conditions and risks. In particular, it has historically been necessary for BioTek to support, and the Company anticipates that it will need to continue to support, the efforts of CMS with direct field sales and support personnel. As a result, the Company generates lower gross margins on sales through CMS than it would generate were it to sell directly to end-users and incurs higher selling expenses than typically associated with third-party distribution arrangements. As a result of these factors and due to the presence of the Company's direct sales force in the United States, the Company does not intend to renew the agreement with CMS upon its expiration in April 1998. The Company has had discussions regarding possible modifications to or early termination of the relationship with CMS. However, these discussions are not currently ongoing. To the extent that CMS does not adequately promote and market batch processing instruments and reagents or manage customer relationships or in the event that difficulties arise in the relationship between the Company and CMS, the Company's sales of batch processing instruments and reagents in the United States could be adversely affected and the Company could also experience disruptions in the supply of batch processing instruments and reagents to customers in the 8 11 United States. These developments could have a material adverse effect on the Company's business, financial condition and results of operations. In connection with BioTek's agreement with DAKO, DAKO made two loans secured by a pledge of substantially all of BioTek's assets. DAKO also made prepayments on future instrument sales and reagent royalties to BioTek. These loans and prepayments were used to fund TechMate 250 instrument development and working capital requirements. The aggregate balance of the secured loans and prepayments was $1.6 million and $0.9 million, respectively, at March 31, 1996. Of the secured loans, $0.3 million bears interest at 5% per annum and the remaining $1.3 million does not bear interest. The prepayments do not bear interest. The secured loans and prepayments are recorded as advances from distributor in the Company's Consolidated Financial Statements. The amounts payable under these loans are repaid through discounts on DAKO instrument purchases from BioTek. Upon termination of the distribution agreement or in the event of a default by BioTek under the distribution agreement (including a failure to satisfy development milestones with respect to the TechMate 250 instrument), the secured loans will convert to fixed term loans that will be due and payable in 12 equal quarterly installments commencing upon such event. Since the acquisition of BioTek, Ventana and DAKO have been engaged in discussions regarding various provisions of the distribution agreement. DAKO has asserted that BioTek has not fulfilled its obligations with respect to development and commercial introduction of the TechMate 250 instrument. The Company denies this assertion and believes that it is in substantial compliance with its obligations under these development milestones. In particular, the Company believes that the recent contract manufacturing agreement with LJL will enable it to satisfy DAKO's requirements for TechMate 250 instruments. Nevertheless, the negotiations with DAKO could result in an attempt by DAKO to exercise contractual remedies available to it under the distribution agreement and terms of the secured loans, an interruption in the distribution of the Company's batch processing instruments outside the United States or litigation between the parties with respect to the agreement, which would involve significant costs as well as diversion of management time. Any of the foregoing could have a material adverse effect on the Company's business, financial condition and results of operations. There can be no assurance that the Company would prevail in any litigation involving the agreement. DAKO's remedies under the agreement include (i) requiring repayment of the secured loans in 12 equal quarterly installments commencing upon a default by BioTek and (ii) an irrevocable license to manufacture TechMate instruments for resale internationally and a related reduction in the fixed dollar royalty rate paid by DAKO to BioTek for each instrument included in the royalty base. There can be no assurance as to the future course or outcome of the Company's negotiations with DAKO or as to the Company's future relationship with DAKO. If DAKO were successful in obtaining a manufacturing license for TechMate instruments, the Company could experience a loss of instrument and royalty revenue which could have a material adverse effect on the Company's business, financial condition and results of operations. In addition, termination of the agreement with DAKO could adversely affect the Company's results of operations. Past and Future Acquisitions. In February 1996 the Company acquired BioTek. Although the Company has no pending agreements or commitments, the Company may make additional acquisitions of complementary businesses, products or technologies in the future. Acquisitions of companies, divisions of companies, or products entail numerous risks, including (i) the potential inability to successfully integrate acquired operations and products or to realize anticipated synergies, economies of scale or other value, (ii) diversion of management's attention, and (iii) loss of key employees of acquired operations. No assurance can be given that the Company will not incur problems in integrating the BioTek operations or any future acquisitions and there can be no assurance that the acquisition of BioTek or any other future acquisition will result in the Company becoming profitable or, if the Company achieves profitability, that such acquisition will increase the Company's profitability. Furthermore, there can be no assurance that the Company will realize value from any such acquisition which equals or exceeds the consideration paid. Any such problems could have a material adverse effect on the Company's business, financial condition and results of operations. In addition, future acquisitions by the Company may result in dilutive issuances of equity securities, the incurrence of additional debt, large one-time write-offs and the creation of goodwill or other intangible assets that could result in 9 12 amortization expense. These factors could have a material adverse effect on the Company's business, financial condition and results of operations. See "Management's Discussion and Analysis of Financial Condition and Results of Operations" and "Business." Patents and Proprietary Rights. The Company's success depends, in part, on its ability to obtain patents, maintain trade secret protection and operate without infringing the proprietary rights of others. There can be no assurance that the Company's patent applications will result in patents being issued or that any issued patents will provide protection against competitive technologies or will be held valid if challenged. Others may independently develop products similar to those of the Company or design around or otherwise circumvent patents issued to the Company. In the event that any relevant claims of third-party patents are upheld as valid and enforceable, the Company could be prevented from practicing the subject matter claimed in such patents, or would be required to obtain licenses from the patent owners of each of such patents or to redesign its products or processes to avoid infringement. There can be no assurance that such licenses would be available or, if available, would be on terms acceptable to the Company or that the Company would be successful in any attempt to redesign its products or processes to avoid infringement. If the Company does not obtain necessary licenses, it could be subject to litigation and encounter delays in product introductions while it attempts to design around such patents. Alternatively, the development, manufacture or sale of such products could be prevented. Litigation would result in significant cost to the Company as well as diversion of management time. Adverse determinations in any such proceedings could have a material adverse effect on the Company's business, financial condition and results of operations. See "Business -- Patents and Proprietary Rights." Ventana also relies upon trade secret protection for its confidential and proprietary information. There can be no assurance that others will not independently develop substantially equivalent proprietary information or techniques, gain access to Ventana's trade secrets or disclose such technology, or that Ventana can effectively protect its trade secrets. Litigation to protect Ventana's trade secrets would result in significant cost to the Company as well as diversion of management time. Adverse determinations in any such proceedings or unauthorized disclosure of Ventana trade secrets could have a material adverse effect on Ventana's business, financial condition and results of operations. BioTek is a party to litigation initiated by BioGenex Laboratories, Inc. ("BioGenex") relating to certain alleged past infringements of patent rights of BioGenex. The Company believes that the resolution of this matter will not have a material adverse effect on the Company's business, financial condition and results of operations. For additional detail regarding this litigation, see "Business -- Legal Proceedings." Uncertainty of Future Funding of Capital Requirements. The Company anticipates that its existing capital resources, including the net proceeds of this Offering and interest earned thereon, will be adequate to satisfy its capital requirements through at least the next 18 to 24 months. The Company's future capital requirements will depend on many factors, including the extent to which the Company's products gain market acceptance, the mix of instruments placed through direct sales or through RAPs, progress of the Company's product development programs, competing technological and market developments, expansion of the Company's sales and marketing activities, the cost of manufacturing scale-up activities, possible acquisitions of complementary businesses, products or technologies, the extent and duration of operating losses and timing of regulatory approvals. The Company may require additional capital resources and there is no assurance such capital will be available to the extent required, on terms acceptable to the Company or at all. Any such future capital requirements could result in the issuance of equity securities which would be dilutive to existing stockholders. See "Management's Discussion and Analysis of Financial Condition and Results of Operations." Dependence on Key Personnel. The Company is dependent upon the retention of principal members of its management, scientific, technical, marketing and sales staff and the recruitment of additional personnel. The Company does not maintain "key person" life insurance on any of its personnel. The Company competes with other companies, academic institutions, government entities and other organizations for qualified personnel in the areas of the Company's activities. The inability to hire or retain qualified personnel could have a material adverse effect on the Company's business, financial condition and results of operations. See "Management." 10 13 Uncertainties Related to Government Funding. A portion of the Company's products are sold to universities, research laboratories, private foundations and other institutions where funding is dependent upon grants from government agencies, such as the National Institutes of Health. Research funding by the government, however, may be significantly reduced under several budget proposals being discussed by the United States Congress or for other reasons. Any such reduction may materially affect the ability of the Company's research customers to purchase the Company's products. FDA and Other Government Regulation. The manufacturing, marketing and sale of the Company's products are subject to extensive and rigorous government regulation in the United States and in other countries. In the United States and certain other countries, the process of obtaining and maintaining required regulatory approvals is lengthy, expensive and uncertain. In the United States, the FDA regulates, as medical devices, clinical diagnostic tests and reagents, as well as instruments used in the diagnosis of adverse conditions. The Federal Food, Drug, and Cosmetic Act governs the design, testing, manufacture, safety, efficacy, labeling, storage, record keeping, approval, advertising and promotion of the Company's products. There are two principal FDA regulatory review paths for medical devices: the 510(k) pre-market notification ("510(k)") process and the pre-market approval ("PMA") process. The PMA process typically requires the submission of more extensive clinical data and is costlier and more time-consuming to complete than the 510(k) process. For a detailed description of this regulatory framework, see "Business -- Government Regulation." The FDA regulates, as medical devices, instruments, diagnostic tests and reagents that are traditionally manufactured and commercially marketed as finished test kits or equipment. Some clinical laboratories, however, choose to purchase individual reagents intended for specific analyses and develop and prepare their own finished diagnostic tests. Although neither the individual reagents nor the finished tests prepared from them by the clinical laboratories have traditionally been regulated by the FDA, the FDA has recently proposed a rule that, if adopted, would regulate the reagents sold to clinical laboratories as medical devices. The proposed rule would also restrict sales of these reagents to clinical laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 ("CLIA") as high complexity testing laboratories. The Company intends to market some diagnostic products as finished test kits or equipment and others as individual reagents; consequently, some or all of these products may be regulated as medical devices. Medical devices generally require FDA approval or clearance prior to being marketed in the United States. The process of obtaining FDA clearances or approvals necessary to market medical devices can be time-consuming, expensive and uncertain, and there can be no assurance that any clearance or approval sought by the Company will be granted or that FDA review will not involve delays adversely affecting the marketing and sale of the Company's products. Further, clearances or approvals may place substantial restrictions on the indications for which the product may be marketed or to whom it may be marketed. Additionally, there can be no assurance that the FDA will not require additional data, require that the Company conduct further clinical studies or obtain a PMA causing the Company to incur further cost and delay. The Company's instruments, with respect to automated IHC testing functions, have been categorized by the FDA as automated cell staining devices and have been exempted from the 510(k) notification process. To date, ISH tests have not received FDA approval and, therefore, use of the gen II for ISH tests will be restricted to research applications. New instrument products that the Company may introduce could require future 510(k) notifications. Certain antibodies that the Company may wish to market with labeling indicating that they can be used in the diagnosis of particular diseases may require PMA approval. In addition, the FDA has proposed that some of the antibody products that Ventana may wish to market be subjected to a pre-filing certification process. Certain of the Company's products are currently sold for research use and are labeled as such. Failure to comply with applicable regulatory requirements can, among other consequences, result in fines, injunctions, civil penalties, suspensions or loss of regulatory approvals, recalls or seizures of products, operating restrictions and criminal prosecutions. In particular, the FDA enforces regulations prohibiting the marketing 11 14 of products for nonindicated uses. In addition, governmental regulations may be established that could prevent or delay regulatory approval of the Company's products. Delays in or failure to receive approval of products the Company plans to introduce, loss of or additional restrictions or limitations relating to previously received approvals, other regulatory action against the Company or changes in the applicable regulatory climate could individually or in the aggregate have a material adverse effect on the Company's business, financial condition and results of operations. The Company is also required to register as a medical device manufacturer with the FDA and is inspected on a routine basis by the FDA for compliance with the FDA GMP regulations. The Company's clinical laboratory customers are subject to CLIA, which is intended to insure the quality and reliability of medical testing. In addition to these regulations, the Company is subject to numerous federal, state and local laws and regulations relating to such matters as safe working conditions and environmental matters. To date, compliance with these laws and regulations has not had a material effect on the Company's financial position; however, there can be no assurance that such laws or regulations will not in the future have a material adverse effect on the Company's business, financial condition and results of operations. See "Business -- Government Regulation." Availability of Third-Party Reimbursement and Effects of Health Care Reform. The Company's ability to achieve revenue growth and profitability may depend on the ability of the Company's customers to obtain adequate levels of third-party reimbursement for use of certain diagnostic tests in the United States, Europe and other countries. Currently, availability of third-party reimbursement is limited and uncertain for some IHC tests. In the United States, the Company's products are purchased primarily by medical institutions and laboratories which bill various third-party payors, such as Medicare, Medicaid, other government programs and private insurance plans, for the health care services provided to their patients. Third-party payors may deny reimbursement to the Company's customers if they determine that a prescribed device or diagnostic test has not received appropriate FDA or other governmental regulatory clearances or approvals, is not used in accordance with cost-effective treatment methods as determined by the payor, or is experimental, unnecessary or inappropriate. The success of the Company's products may depend on the extent to which appropriate reimbursement levels for the costs of such products and related treatment are obtained by the Company's customers from government authorities, private health insurers and other organizations, such as health maintenance organizations ("HMOs"). Third-party payors are increasingly challenging the prices charged for medical products and services. The trend towards managed health care in the United States and the concurrent growth of organizations such as HMOs could significantly influence the purchase of health care services and products. In addition, the federal government and certain members of Congress have proposed, and various state governments have adopted or are considering, programs to reform the health care system. These proposals are focused, in large part, on controlling the escalation of health care expenditures. The cost containment measures that health care payors are instituting and the impact of any health care reform could have a material adverse effect on the levels of reimbursement the Company's customers receive from third-party payors and the Company's ability to market and sell its products and consequently could have a material adverse effect on the Company's business, financial condition and results of operations. See "Business -- Third-Party Reimbursement." Product Liability and Recalls; Product Liability Insurance. Although to date the Company has not experienced any product liability claims, the marketing and sale of the Company's diagnostic instruments and reagents entails such risks. The Company has product liability insurance coverage with a per occurrence maximum of $2.0 million and an aggregate annual maximum of $5.0 million. There can be no assurance that this level of insurance coverage will be adequate or that insurance coverage will continue to be available on acceptable terms or at all. A product liability claim or recall could have a material adverse effect on the Company's business, reputation, financial condition and results of operations. 12 15 Control by Existing Stockholders; Anti-Takeover Provisions. After this Offering, the Company's officers, directors and principal stockholders will beneficially own approximately 55% of the Company's outstanding Common Stock. These stockholders will be able to elect all members of the Company's Board of Directors and will have the ability to control corporate actions requiring stockholder approval. Such concentration of ownership may have the effect of delaying or preventing a change in control of the Company. In addition, the Board of Directors has the authority, without action by the stockholders, to fix the rights and preferences of, and issue shares of, one or more series of preferred stock, which may have the effect of delaying or preventing a change in control of the Company, and to issue additional Common Stock which would be dilutive to existing stockholders. In addition, provisions in the Company's Certificate of Incorporation and Bylaws (i) prohibit the stockholders from acting by written consent without a meeting or calling a special meeting of stockholders and (ii) require advance notice of business proposed to be brought before an annual or special meeting of stockholders. The amendment or modification of these provisions will require the affirmative vote of the holders of 66 2/3% of the outstanding shares of Common Stock. See "Principal and Selling Stockholders" and "Description of Capital Stock." Absence of Prior Public Market; Possible Volatility of Stock Price. Prior to this Offering, there has been no public market for the Company's Common Stock. There can be no assurance that an active trading market for the Common Stock will develop or, if developed, will be sustained. The public offering price will be established by negotiations between the Company and the Representatives of the Underwriters and may bear no relationship to the price at which the Company's Common Stock trades after the Offering. See "Underwriting" for a discussion of the factors to be considered in determining the initial public offering price. In addition, the market price of the Company's Common Stock, similar to the securities of other medical device and life sciences companies, is likely to be highly volatile. Factors such as fluctuations in the Company's operating results, announcements of technological innovations or new products by the Company or its competitors, FDA and other government regulation, developments with respect to patents or proprietary rights, public concern as to the safety of products developed by the Company or others, changes in financial analysts' estimates or recommendations regarding the Company and general market conditions may have a material adverse effect on the market price of the Company's Common Stock. The Company's results of operations may, in future periods, fall below the expectations of public market analysts and investors and, in such event, the market price of the Company's Common Stock could be materially adversely affected. Shares Eligible for Future Sale. Sales of Common Stock (including shares issued upon the exercise of outstanding options) in the public market after this Offering could impair the Company's ability to raise capital through an offering of securities and could materially adversely affect the market price of the Common Stock. Such sales also might make it more difficult for the Company to sell equity securities or equity-related securities in the future at a time and price that the Company deems appropriate or at all. Upon consummation of this Offering, the Company will have 10,974,883 shares of Common Stock outstanding, of which the 3,000,000 Shares offered hereby will be freely tradable (unless held by affiliates of the Company) and the remaining 7,974,883 shares will be restricted securities within the meaning of the Securities Act of 1933, as amended (the "Securities Act"). Approximately 39,703 of such shares will be available for immediate public resale on the date of this Offering. An additional 8,778 shares of Common Stock will be saleable between 90 and 180 days after this Offering. The Company's directors, executive officers and certain stockholders, who in the aggregate hold 7,551,250 shares of Common Stock of the Company outstanding immediately prior to the completion of this Offering, have entered into or are subject to lock-up agreements under which they have agreed not to sell, directly or indirectly, any shares owned by them for a period of 180 days after the date of this Prospectus without the prior written consent of Bear, Stearns & Co. Inc. Holders of outstanding options to purchase Common Stock have entered into or are subject to similar agreements. Upon expiration of the 180-day lock-up agreements, approximately 7,900,451 shares of Common Stock (including approximately 349,201 shares subject to outstanding vested options) will become eligible for immediate public resale, subject in some cases to vesting provisions and volume limitations pursuant to Rule 144. The remaining approximately 310,908 shares held by existing stockholders will become eligible for public resale at various times over a period of less than two years following the completion of this Offering, subject in some cases to vesting provisions and volume limitations. 7,277,777 of the shares outstanding immediately following the completion 13 16 of this Offering will be entitled to registration rights with respect to such shares upon termination of lock-up agreements. The number of shares sold in the public market could increase if registration rights are exercised. See "Description of Capital Stock -- Registration Rights" and "Shares Eligible for Future Sale." Dilution. The initial public offering price is substantially higher than the net tangible book value per share of Common Stock. Investors purchasing shares of Common Stock in this Offering will therefore incur immediate and substantial dilution. See "Dilution." Absence of Dividends. The Company has not declared or paid any cash dividends since its inception and does not anticipate paying any dividends in the foreseeable future. In addition, the Company's bank credit agreement currently prohibits the Company from paying cash dividends. See "Dividend Policy." 14 17 THE COMPANY Ventana was incorporated in California in June 1985 and was reincorporated in Delaware in December 1993. As used in this Prospectus, the terms "Ventana" and the "Company" refer to Ventana Medical Systems, Inc. and its subsidiaries, Ventana Medical Systems, S.A., Ventana Medical Systems GmbH and BioTek Solutions, Inc. unless the context otherwise requires. The Company's principal executive offices are located at 3865 North Business Center Drive, Tucson, Arizona 85705. Its telephone number is (520) 887-2155. Ventana(TM), the Ventana logo(TM), ES(TM), gen II, TechMate(TM) and CheMate(TM) are trademarks of the Company. Trademarks of others are also referred to in this Prospectus. USE OF PROCEEDS The net proceeds to the Company from the sale of the Shares of Common Stock offered hereby are estimated to be approximately $30.0 million assuming an initial public offering price of $15.00 per share and after deducting the estimated underwriting discounts and commissions and expenses of the Offering. The Company intends to use $15.9 million of the estimated net proceeds from the Offering to repay (i) $13.9 million of debt incurred in connection with the acquisition of BioTek and financing of related working capital requirements (the "Acquisition Debt") and (ii) a $2.0 million bank term loan (the "Term Loan"). The Acquisition Debt bears interest at 7% per annum and matures in February 1998; however, accrued interest will be forgiven if the principal is repaid prior to December 31, 1996. The Acquisition Debt is due and payable 30 days after the completion of this Offering. The Term Loan bears interest at a rate of 2% over the bank's prime rate, is secured by a pledge of the Company's assets and matures in March 1999. The Company expects to use approximately $1.8 million of the net proceeds during the next 12 months for capital expenditures for manufacturing and computer equipment. The Company anticipates that the estimated remaining net proceeds of $12.3 million will be used for working capital and general corporate purposes. Although the Company may use a portion of the net proceeds for the acquisition of complementary businesses, products or technologies, the Company currently has no agreements or commitments in this regard. Pending such uses, the Company intends to invest the net proceeds of the Offering in short-term, interest-bearing, investment-grade securities. The Company will not receive any proceeds from the sale of Shares by the Selling Stockholders. DIVIDEND POLICY The Company has not declared or paid any dividends since its inception and does not intend to pay any dividends in the foreseeable future. In addition, the Company's bank credit agreement currently prohibits the Company from paying cash dividends. 15 18 DILUTION The net tangible book value of the Company at March 31, 1996 was $(10.9) million or $(1.33) per share after giving effect to the conversion of the Preferred Stock into Common Stock and the issuance of 64,244 shares of Common Stock upon the assumed exercise of outstanding warrants which would otherwise expire upon the closing of this Offering. The net tangible book value per share represents the Company's total tangible assets less total liabilities, divided by the number of shares of Common Stock outstanding (assuming conversion of the Preferred Stock). Dilution per share represents the difference between the amount per share paid by investors in this Offering and the net tangible book value per share after the Offering. After giving effect to (i) the sale of Shares in this Offering at an assumed initial public offering price of $15.00 per share and (ii) the issuance of 64,244 shares of Common Stock upon the assumed exercise of outstanding warrants which would otherwise expire upon the closing of this Offering, the estimated net proceeds to the Company would be approximately $30.0 million and the net tangible book value of the Company at March 31, 1996 would be $19.3 million or $1.74 per share. This represents an immediate increase in net tangible book value of $3.07 per share to existing stockholders and an immediate dilution in net tangible book value of $13.26 per share to new investors purchasing Shares at the assumed initial public offering price. The following table illustrates this per share dilution: Assumed initial public offering price per share.......................... $15.00 Net tangible book value per share before the Offering.................. $(1.33) Increase per share attributable to new investors....................... 3.07 ------ Net tangible book value per share after the Offering..................... 1.74 ------ Immediate dilution per share to new investors............................ $13.26 ======
The following table summarizes, as of March 31, 1996, the difference between the existing stockholders and new investors purchasing Shares in this Offering with respect to the number of Shares of Common Stock purchased, the total consideration paid and the average price per share paid (assuming an initial public offering price of $15.00 per share):
SHARES PURCHASED TOTAL CONSIDERATION ---------------------- ----------------------- AVERAGE PRICE NUMBER PERCENT AMOUNT PERCENT PER SHARE ---------- ------- ----------- ------- ------------- Existing stockholders.............. 8,073,117 79% $31,508,000 49% $ 3.90 New investors...................... 2,200,000 21% 33,000,000 51% 15.00 ------- --- ------- --- Total.................... 10,273,117 100% $64,508,000 100% $ 6.28 ======= === ======= ===
The computations in the above table (i) are determined before deducting the underwriting discounts and commissions and estimated expenses of the Offering payable by the Company, (ii) assume no exercise of outstanding stock options or warrants, other than the issuance of 64,244 shares of Common Stock upon the assumed exercise of outstanding warrants which would otherwise expire upon the closing of this Offering and (iii) do not give effect to stock issuance activity subsequent to March 31, 1996, which consists of 646,659 shares issued upon the exercise of stock purchase rights and 55,107 shares issued upon the exercise of options and warrants through May 15, 1996. At May 15, 1996, there were options outstanding to purchase 840,357 shares of Common Stock at an exercise price of $2.48 per share. In addition, warrants to purchase 879,183 shares of Common Stock at an exercise price of $5.82 per share may remain outstanding upon the completion of this Offering. To the extent outstanding options and warrants are exercised, there will be further dilution to new investors. See "Management -- Incentive Stock Plans," "Description of Capital Stock" and Notes 7 and 10 to the Consolidated Financial Statements. 16 19 CAPITALIZATION The following table sets forth the capitalization of the Company as of March 31, 1996, after giving effect to the conversion of the Preferred Stock into Common Stock upon the closing of the Offering, the restatement of the Company's Certificate of Incorporation to provide for authorized capital stock consisting of 50,000,000 shares of Common Stock and 5,000,000 shares of undesignated preferred stock, and adjusted for the receipt of the estimated net proceeds from the sale of Common Stock offered hereby and the application thereof:
MARCH 31, 1996 ------------------------ AS ACTUAL ADJUSTED(1) -------- ----------- (IN THOUSANDS) Long-term debt(2)..................................................... $ 15,035 $ -- Stockholders' equity: Preferred Stock: $.001 par value, 5,000,000 shares authorized; none outstanding...................................................... -- -- Common Stock: $.001 par value, 50,000,000 shares authorized; 8,008,890 shares issued and outstanding and; 10,273,117 shares issued and outstanding, as adjusted-amount paid in(3)(4)(5)...... 31,016 61,028 Accumulated deficit(6)................................................ (29,398) (29,398) Cumulative foreign currency translation adjustment.................... (143) (143) -------- -------- Total stockholders' equity(4)(5).................................... 1,475 31,487 -------- -------- Total capitalization........................................ $ 16,510 $ 31,487 ======== ========
- --------------- (1) As adjusted shares outstanding includes the issuance of 64,244 shares of Common Stock upon the assumed exercise of outstanding warrants which would otherwise expire upon the closing of this Offering. As adjusted shares outstanding excludes 840,357 shares issuable upon exercise of stock options outstanding under the Company's 1988 Incentive Stock Option Plan as of May 15, 1996 and warrants to purchase 879,183 shares of Common Stock which may remain outstanding upon completion of this Offering. As adjusted shares outstanding does not give effect to stock issuance activity after March 31, 1996, which consists of 646,659 shares issued upon exercise of stock purchase rights and 55,107 shares issued upon the exercise of options and warrants through May 15, 1996. See "Management -- Incentive Stock Plans," "Description of Capital Stock" and Notes 7 and 10 to the Consolidated Financial Statements. (2) As of March 31, 1996, the Company had outstanding borrowings of $1.0 million under the bank credit agreement. Subsequent to March 31, 1996, the Company borrowed an additional $1.0 million, all of which was converted into a $2.0 million term loan which will be repaid with the proceeds of this Offering. (3) Assumes net proceeds of $30.0 million from this Offering based on an assumed initial public offering price of $15.00 per share. (4) See Notes 6 and 7 to the Consolidated Financial Statements. (5) Actual amounts reflect the assumed conversion of the Preferred Stock but not the exercise of warrants which would otherwise expire upon the closing of this Offering. (6) Gives effect to cancellation of accrued Preferred Stock dividends upon the assumed conversion of the Preferred Stock into Common Stock. 17 20 SELECTED CONSOLIDATED ACTUAL AND PRO FORMA FINANCIAL AND OPERATING DATA The selected consolidated statement of operations data set forth below for the years ended December 31, 1995, 1994 and 1993, except for the components of net sales, are derived from the Company's audited Consolidated Financial Statements included elsewhere in this Prospectus. The selected consolidated statement of operations data set forth below for the years ended December 31, 1992 and 1991, except for the components of net sales, are derived from audited financial statements of the Company not included in this Prospectus. The selected actual consolidated statement of operations data for the three months ended March 31, 1996 and 1995, the components of net sales for all periods presented, and the balance sheet data at March 31, 1996 are derived from unaudited financial statements of the Company, which, in the opinion of management, include all adjustments, consisting only of normal recurring adjustments, necessary for a fair presentation of the financial position and results of operations for the unaudited periods. The selected pro forma statement of operations data are derived from the Unaudited Pro Forma Condensed Consolidated Financial Statements included elsewhere in this Prospectus. The unaudited interim information and pro forma information for the periods presented is not necessarily indicative of the results which may be realized in the future. The selected actual and pro forma consolidated financial and operating data set forth below should be read in conjunction with "Management's Discussion and Analysis of Financial Condition and Results of Operations" and the Consolidated Financial Statements and Notes thereto included elsewhere in this Prospectus.
ACTUAL PRO FORMA(1) -------------------------------------------------------------------- ------------------------------------- THREE MONTHS THREE MONTHS ENDED YEAR ENDED YEAR ENDED DECEMBER 31, MARCH 31, DECEMBER 31, ENDED MARCH 31, STATEMENT OF ----------------------------------------------- ------------------ ------------------ ---------------- OPERATIONS: 1991 1992 1993 1994 1995 1995 1996 1994 1995 1995 1996 ------- ------- ------- ------- ------- ------- -------- -------- ------- ------- ------ (IN THOUSANDS, EXCEPT PER SHARE DATA) Sales: Instruments...... $ 50 $ 717 $ 1,162 $ 2,588 $ 4,644 $ 1,007 $ 1,594 $ 5,798 $ 8,396 $ 2,040 $1,733 Reagents and other.......... 28 452 1,519 3,339 5,969 1,195 2,552 6,647 11,079 2,378 3,495 ------- ------- ------- -------- ------- ------- ------- ------ ------ Total net sales........ 78 1,169 2,681 5,927 10,613 2,202 4,146 12,445 19,475 4,418 5,228 Cost of goods sold............. 49 832 1,722 2,531 4,282 936 1,435 5,883 9,096 2,134 1,927 ------- ------- ------- -------- ------- ------- ------- ------ ------ Gross profit....... 29 337 959 3,396 6,331 1,266 2,711 6,562 10,379 2,284 3,301 Operating expenses: Research and development.... 1,352 1,194 2,100 1,926 2,239 556 613 2,687 4,407 721 771 Selling, general and administrative... 892 2,465 4,067 6,899 7,435 1,594 2,279 9,942 10,968 2,367 2,704 ------- ------- ------- -------- ------- ------- ------- ------ ------ Loss from operations before nonrecurring expenses and amortization of intangibles...... (2,215) (3,322) (5,208) (5,429) (3,343) (884) (181) (6,067) (4,996) (804) (174) Nonrecurring expenses......... -- -- -- -- -- -- (7,083) (8,373) -- -- -- Amortization of intangibles...... -- -- -- -- -- -- -- (1,344) (1,344) (336) (336) ------- ------- ------- -------- ------- ------- ------- ------ ------ Loss from operations....... (2,215) (3,322) (5,208) (5,429) (3,343) (884) (7,264) (15,784) (6,340) (1,140) (510) Interest income (expense)........ 23 48 229 59 74 50 (5) 59 74 50 (5) ------- ------- ------- -------- ------- ------- ------- ------ ------ Net loss........... $(2,192) $(3,274) $(4,979) $(5,370) $(3,269) $ (834) $ (7,269) $(15,725) $(6,266) $(1,090) $ (515) ======= ======= ======= ======== ======= ======= ======= ====== ====== Per share data(2): Net loss per share, as adjusted....... $ (0.39) $ (0.10) $ (0.85) $ (0.66) $ (0.12) $(0.05) ======= ======= ======= ====== Shares used in computing net loss per share, as adjusted.... 8,354 8,220 8,585 9,466 9,331 9,696 ======= ======= ======= ======
MARCH 31, 1996 --------------------------- ACTUAL AS ADJUSTED(3) -------- -------------- (IN THOUSANDS) BALANCE SHEET DATA: Cash and cash equivalents........................................................................ $ 3,436 $ 18,413 Long-term debt................................................................................... 15,035 -- Working capital.................................................................................. 1,195 16,172 Total assets..................................................................................... 24,752 39,729 Accumulated deficit(4)(5)........................................................................ (29,398 ) (29,398) Total stockholders' equity(5).................................................................... 1,475 31,487
- --------------- (1) Adjusted to reflect the acquisition of BioTek as of January 1, 1994. BioTek was acquired February 26, 1996. (2) See Note 1 to Consolidated Financial Statements and Note 8 to the Unaudited Pro Forma Condensed Consolidated Financial Statements for information concerning the computation of net loss per share. (3) Adjusted to give effect to the receipt of the net proceeds from the sale of the Shares of Common Stock offered by the Company hereby and the application thereof at an assumed initial public offering price of $15.00 per share. See "Use of Proceeds" and "Capitalization." (4) Gives effect to cancellation of accrued Preferred Stock dividends upon the assumed conversion of the Preferred Stock into Common Stock. (5) Actual amounts reflect the assumed conversion of the Preferred Stock but not the exercise of warrants which would otherwise expire upon the closing of this Offering. 18 21 SELECTED OPERATING DATA: The following table sets forth the Company's annual pro forma instrument placements and instrument installed base for the periods indicated as if the acquisition of BioTek had taken place on January 1, 1992:
THREE MONTHS ENDED MARCH YEAR ENDED DECEMBER 31, 31 ------------------------------- ------------- 1992 1993 1994 1995 1995 1996 ---- ---- ---- ---- ---- ---- INSTRUMENT PLACEMENTS (UNITS): Patient priority.................................. 17 56 74 113 28 33 Batch processing.................................. 4 37 106 128 35 12 -- --- --- --- --- --- Total current placements..................... 21 93 180 241 63 45 == === === === === === RAPs in current placements........................ 6 19 19 22 8 6 == === === === === === INSTRUMENT INSTALLED BASE (UNITS): Patient priority.................................. 18 74 148 261 176 294 Batch processing.................................. 4 41 147 275 182 287 -- --- --- --- --- --- Total instrument installed base.............. 22 115 295 536 358 581 == === === === === === RAPs in installed base............................ 6 25 44 66 52 72 == === === === === ===
19 22 MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS The following discussion of the financial condition and historical and pro forma results of operations of the Company should be read in conjunction with the Financial Statements and related Notes thereto included elsewhere in this Prospectus. This Prospectus contains forward-looking statements which involve risks and uncertainties. The Company's actual results may differ materially from those anticipated by the forward-looking statements as a result of certain factors, including those set forth in Risk Factors and elsewhere in this Prospectus. OVERVIEW Ventana develops, manufactures and markets proprietary instrument/reagent systems that automate IHC and ISH tests for the analysis of cells and tissues on microscope slides. Each Ventana proprietary system placed provides a recurring revenue stream as customers consume reagents and supplies sold by the Company with each test conducted. Reagents consist of two components: a primary antibody and a detection chemistry which is used to visualize the primary antibody. Therefore, the principal economic drivers for the Company are the number, type and method of sale of instruments placed and the amount of reagents and consumables used by the customer. The Company's strategy is to maximize the number of instruments placed with customers and thereby increase its ongoing, higher margin reagent revenue stream. The Company expects that reagents will comprise a greater proportion of total revenues in the future as its installed base of instruments increases, as new instrument placements represent a smaller percentage of the Company's existing installed base of instruments and as RAP placements increase as a percentage of total instrument placements. In February 1996, Ventana acquired BioTek for aggregate consideration of $18.8 million, consisting of cash, promissory notes and the assumption of liabilities. BioTek, founded in 1990, markets and sells automated diagnostic systems that perform reliable, high volume batch processing of a single IHC test on multiple patient biopsies. Ventana acquired BioTek for several strategic reasons including its installed instrument base and complementary product line. Historically, BioTek generated lower gross margins than Ventana due to its employment of a different business strategy which primarily involved the use of third parties for key activities. BioTek's instruments were produced by third-party manufacturers which prevented BioTek from capturing manufacturing margin. BioTek's instruments have an open configuration, enabling the customer to use reagents purchased from BioTek or others which impacted both the price and volume of reagents purchased by customers from BioTek. In contrast, Ventana's instruments have a closed configuration requiring the customer to use Ventana's prepackaged detection chemistries. BioTek also realized lower gross margins on reagents than Ventana due to its utilization of intermediate materials in the manufacturing process which resulted in the capture of fewer value-added steps. BioTek used CMS and DAKO as third-party distributors in the United States and international markets, respectively, and supported its United States sales efforts with field sales and technical support personnel. As a result, BioTek experienced both lower gross margins than if it had sold its products directly and a higher level of selling expense than typically incurred in conjunction with third-party distribution arrangements. Ventana's goal is to integrate the operations of BioTek into the Ventana business model, in which manufacturing, sales and marketing activities are performed by Company employees. In May 1996, the Company completed the integration of the BioTek and Ventana direct field sales and technical personnel. The Company does not intend to renew the United States distribution agreement with CMS which expires in April 1998. The Company is engaged in discussions with DAKO regarding various aspects of the distribution arrangement. The international distribution agreement with DAKO expires in December 1999. The Company expects to complete the consolidation of BioTek's reagent manufacturing into Ventana's Tucson facilities in September 1996. Following this consolidation, the Company intends to convert BioTek's reagent manufacturing to the process used by Ventana in which basic raw materials are used and important value-added steps are performed internally. The Company believes that in the near term it will be more cost effective to continue sourcing batch processing instruments from third-party manufacturers. The Company expects to complete a contract manufacturing agreement with Kollsman for the TechMate 500 instrument and has entered into an 20 23 agreement with LJL for production of the Company's next generation batch processing instrument, the TechMate 250. From its inception in 1985 through its first commercial sale in late 1991, Ventana's activities consisted primarily of research and development of its instrument and reagent systems. During this period, Ventana incurred aggregate net losses of $5.2 million. During the period from January 1, 1992 through March 31, 1996, the Company incurred additional net losses of $24.2 million including $7.1 million related to the expensing of in-process research and development and restructuring costs associated with the acquisition of BioTek for cumulative losses of $29.4 million as of March 31, 1996. Similarly, BioTek incurred over $17.7 million in losses from operations from its inception in October 1990 until its acquisition by the Company in February 1996. The Company expects that it will continue to incur losses through at least the first half of 1997 as a result of expenses associated with the integration of BioTek's operations and expenses associated with the expansion of manufacturing, sales and marketing activities. There can be no assurance that the Company will achieve profitability or that profitability, if achieved, will be sustained on an annual or quarterly basis, or at all. The Company provides a number of alternatives for instrument placements including direct sales, non-recourse lease and rental programs and RAPs. Under a RAP, the customer obtains the use of an instrument with no capital investment in exchange for the customer's commitment to purchase reagents from the Company at a higher price per unit than if the customer had purchased the instrument. The terms of RAP arrangements vary from customer to customer; however, the Company's current RAPs are generally for a one-year term, are renewed automatically unless the customer gives notice of nonrenewal and are cancellable during an initial 180-day trial period. To date, no instruments placed through RAPs have been returned by the user and some RAP customers have purchased the instruments. For instruments placed through RAPs, the Company incurs the cost of manufacturing or procuring instruments and recognizes revenues only as customers purchase reagents rather than at the time of instrument placement. The manufacturing cost of instruments placed through RAPs is charged to cost of goods sold by depreciating standard costs over a period of three or four years. As a result, gross profit for instruments placed through RAPs is recognized over a three or four year period rather than at the time of placement, as is the case in direct sales. Revenue associated with instruments placed through RAPs is based on a volume pricing matrix which is designed to enable the Company to recover the sales value of the instrument through an increased price on the reagents purchased by the user. The Company typically recovers the cash costs associated with the placement of instruments through RAPs in less than two years. Due to the working capital requirements associated with RAPs, the Company has historically sought to limit the amount of instruments placed through RAPs to approximately 30% of instrument placements. However, the Company anticipates that the percentage of instruments placed through RAPs will increase with the introduction of the NexES and TechMate 250 and as the Company obtains the additional working capital required to support additional RAP placements, which may in the future result in a decrease in instrument sales both in absolute dollars and as a percentage of total revenues. As of March 31, 1996, the Company had placed 72 instruments through RAPs. The Company's future results of operations may fluctuate significantly from period to period due to a variety of factors. The initial placement of an instrument is subject to a longer, less consistent sales cycle than the sale of reagents which begin and are recurring once an instrument is placed. The Company's operating results in the future are likely to fluctuate substantially from period to period because instrument sales are likely to remain an important part of revenues in the near future. Results of operations for the remainder of 1996 are also expected to be affected by costs associated with the integration of BioTek's operations. These include costs associated with centralizing reagent manufacturing, expanding reagent product offerings for batch processing instruments and eliminating operational redundancies. Other factors that may result in fluctuations in operating results include introduction of new products and new technologies by the Company and its competitors, market acceptance of the Company's current or new products, developments with respect to regulatory matters, availability and cost of raw materials purchased from suppliers, competitive pricing pressures, increased sales and marketing expenses associated with the implementation of the Company's market expansion strategies, and increased research and development expenditures. In addition, a significant portion of the Company's expense levels are based on its expectation of a higher level of revenues in the future 21 24 and are relatively fixed in nature. Therefore, if revenue levels are below expectations, operating results in a given period are likely to be adversely affected. Total revenues grew from $2.7 million in 1993 to $10.6 million in 1995, a compound annual growth rate of 98%. Instrument sales grew from $1.2 million in 1993 to $4.6 million in 1995, a compound annual growth rate of 96%. Reagent sales grew from $1.5 million in 1993 to $6.0 million in 1995, a compound annual growth rate of 100%. The growth in revenues is primarily attributable to the growth in (i) instrument placements and (ii) the instrument installed base and the associated corresponding increase in the aggregate recurring reagent revenue stream. The Company's installed base of instruments increased from 74 in 1993 to 261 in 1995. Instrument placements have increased in every year, from 56 in 1993 to 113 in 1995. The Company's installed base of instruments was significantly enhanced by the BioTek acquisition in the first quarter of 1996. Gross margin increased from 36% in 1993 to 60% in 1995 as both instrument and reagent gross margins increased. Gross margin increased primarily due to a higher level of revenues available to cover fixed costs and economies of scale and efficiencies in purchasing and manufacturing activities. Research and development and selling, general and administrative expenses in the period were maintained at levels that anticipated a higher level of revenues in the future, which resulted in operating losses in each year between 1993 and 1995. RESULTS OF OPERATIONS THREE MONTHS ENDED MARCH 31, 1996 AND 1995 Ventana acquired BioTek on February 26, 1996. Consequently, approximately one month of BioTek operations are included in the results of operations for the three months ended March 31, 1996. Net Sales Presented below is a summary of revenue, instrument placements and instrument installed base for the three months ended March 31, 1996 and 1995.
THREE MONTHS ENDED MARCH 31, ----------------------------------------------- 1995 --------------------- $ ------ 1996 REVENUE SUMMARY: --------------------- % OF SALES $ % OF SALES ---------- ------ ---------- (DOLLARS IN THOUSANDS) Instruments............................... $1,007 46% $1,594 38% Reagents and other........................ 1,195 54% 2,552 62% ------ ---- ------ ---- Total revenue..................... $2,202 100% $4,146 100% ====== ==== ====== ====
THREE MONTHS INSTRUMENT PLACEMENTS (UNITS): ENDED MARCH 31, --------------- Patient priority: 1995 ---- 1996 ---- IHC/ES............................................................. 23 30 ISH/gen II......................................................... 5 3 -- - --- Total patient priority..................................... 28 33 Batch processing..................................................... -- 7 -- - --- Total current placements................................... 28 40 === === RAPs in current placements........................................... 8 6
22 25
MARCH 31, ------------------ INSTRUMENT INSTALLED BASE (UNITS): 1995 1996 ---- ------- Patient priority: IHC/ES........................................................... 174 276 ISH/gen II....................................................... 2 18 --- --- Total patient priority................................... 176 294 Batch processing................................................... -- 287 --- --- Total instrument installed base.......................... 176 581 === === RAPs in installed base............................................. 52 72
Net sales for the three months ended March 31, 1996 increased 88% to $4.1 million from $2.2 million in the three months ended March 31, 1995. The increase in net sales was attributable to a 58% increase in instrument sales and a 114% increase in reagent sales. Instrument sales increased due to increased instrument placements and higher selling prices associated with gen II placements. Reagent sales increased due to sales of reagents to new customers, as well as to increases in reagent sales to existing customers. United States patient priority reagent consumption by customers with instruments in place before October 1, 1994 increased an average of 19% from the first quarter of 1995 to the first quarter of 1996. Gross Margin Gross profit for the three months ended March 31, 1996 increased to $2.7 million from $1.3 million in the three months ended March 31, 1995. Gross margin for the three months ended March 31, 1996 increased to 65% from 58% in the three months ended March 31, 1995. Overall gross margins increased primarily due to a shift in revenue mix toward higher margin reagent products. Gross margins on instrument sales increased due to increased sales of gen II instruments, improvements in manufacturing efficiencies and increased absorption of manufacturing overhead. Gross margins on reagent sales increased due to economies of scale associated with increased volumes and improvements in manufacturing efficiencies. Research and Development Research and development expense was approximately equal in the three months ended March 31, 1996 and 1995, but declined to 15% of net sales in the period ended March 31, 1996 from 25% of net sales in the period ended March 31, 1995. Research and development expense for the three months ended March 31, 1996 related primarily to the development of new reagents and instruments, including the NexES. Research and development expense for the period ended March 31, 1995 related primarily to gen II instrument development and reagent development. Selling, General and Administrative ("SG&A") Presented below is a summary of SG&A expense for the three months ended March 31, 1996 and 1995.
THREE MONTHS ENDED MARCH 31, ----------------------------------------------- 1995 1996 --------------------- --------------------- $ % OF SALES $ % OF SALES ------ ---------- ------ ---------- (DOLLARS IN THOUSANDS) Sales and marketing......................... $1,212 55% $1,701 41% Administration.............................. 382 17% 578 14% ------ ---------- ------ ---------- Total SG&A........................ $1,594 72% $2,279 55% ====== ======== ====== ========
SG&A expense in the three months ended March 31, 1996 increased to $2.3 million from $1.6 million in the three months ended March 31, 1995, but declined to 55% of net sales in the period ended March 31, 1996 from 72% of net sales in the period ended March 31, 1995. The fluctuation in SG&A expense from period to period reflects the growth of Ventana's internal sales and marketing organization to facilitate its market expansion strategy and a corresponding increase in infrastructure expenses to support a larger business base. The growth in sales and marketing expense is the result of the Company's decision to service the market 23 26 through its own sales and marketing staff and expenses needed to support sales growth. Increases in administrative expense are associated with the Company's regulatory strategy and costs associated with supporting an expanding business base. In-Process Research and Development Expense In accordance with Statement of Financial Accounting Standards No. 2 "Accounting for Research and Development Costs" ("FAS 2"), the Company charged to expense at the date of the acquisition of BioTek, $5.0 million relating to the portion of the purchase price allocated to those in-process research and development projects where technological feasibility had not yet been established and for which there are no alternative future uses. YEARS ENDED DECEMBER 31, 1995, 1994 AND 1993 Net Sales Presented below is a summary of revenue, instrument placements and instrument installed base for the three years ended December 31, 1995, 1994 and 1993.
YEAR ENDED DECEMBER 31, ---------------------------------------------------------------- 1993 1994 1995 ------------------- ------------------- -------------------- $ % OF SALES $ % OF SALES $ % OF SALES ------ ---------- ------ ---------- ------- ---------- (DOLLARS IN THOUSANDS) REVENUE SUMMARY: Instruments..................... $1,162 43% $2,588 44% $ 4,644 44% Reagents and other.............. 1,519 57% 3,339 56% 5,969 56% ------ ---- ------ ---- ---- Total revenue......... $2,681 100% $5,927 100% $10,613 100% ====== ==== ====== ==== ====
YEAR ENDED DECEMBER 31, ---------------------- INSTRUMENT PLACEMENTS (UNITS): 1993 1994 1995 ---- ---- ---- Patient priority: IHC/ES................................................................ 56 74 98 ISH/gen II............................................................ -- -- 15 -- --- --- Total current placements...................................... 56 74 113 == === === RAPs in current placements.............................................. 19 19 22 == === ===
DECEMBER 31, ---------------------- INSTRUMENT INSTALLED BASE (UNITS): 1993 1994 1995 ---- ---- ---- Patient priority: IHC/ES................................................................ 74 148 246 ISH/gen II............................................................ -- -- 15 -- --- --- Total instrument installed base............................... 74 148 261 == === === RAPs in installed base.................................................. 25 44 66 == === ===
Net sales for the year ended December 31, 1995 increased by 79% to $10.6 million from $5.9 million for the year ended December 31, 1994. Net sales for the year ended December 31, 1994 increased by 121% to $5.9 million from $2.7 million for the year ended December 31, 1993. The increases in net sales were attributable to increases in instrument sales as well as increases in reagent sales. Instrument sales increased over the prior year by 79% in 1995 and 123% in 1994, respectively. Reagent sales increased over the prior year by 79% in 1995 and 120% in 1994, respectively. Instrument sales increased during these periods primarily due to increased placements. Instrument sales in 1995 were positively impacted by the higher selling prices associated with gen II instrument placements. Instrument sales in 1995 and 1994 were impacted by the 24 27 placement of a significant number of instruments through RAPs, which resulted in lower instrument revenues than if the placements had been made on a direct sale basis. Reagent sales grew primarily because of the growth in the installed base of instruments, as well as increased sales to existing customers. Despite the growth in the Company's installed base of instruments from 1993 to 1995, reagent sales as a percentage of net sales did not increase significantly. This was due primarily to (i) the high percentage of new instrument placements in each year relative to the existing installed base of instruments, (ii) the recognition of revenues on direct instrument sales at the time of sale and (iii) the receipt of reagent revenue for only that portion of the year during which an instrument was in place. Gross Margin Gross profit for the year ended December 31, 1995 increased to $6.3 million from $3.4 million in the year ended December 31, 1994 and $1.0 million in the year ended December 31, 1993. Gross margin increased to 60% in 1995 from 57% in 1994 and 36% in 1993. The improvement in gross margin resulted primarily from a higher volume of revenues available to cover the Company's fixed costs, economies of scale and efficiencies in manufacturing operations. Gross margins on instruments increased in 1994 as compared to 1993 primarily due to reductions in instrument manufacturing costs. Instrument gross margins in 1995 were approximately equivalent to 1994. Reagent gross margins decreased in 1994 as compared to 1993 due primarily to primary antibody promotional programs initiated during 1994 and partially offset by improvements in manufacturing efficiencies during 1994. Reagent gross margins in 1995 increased compared to 1994 and exceeded the margins achieved in 1993 because the Company (i) discontinued its primary antibody promotional programs, (ii) realized lower material prices from higher purchasing volumes and (iii) achieved improvements in manufacturing efficiencies. Research and Development Research and development expense in the year ended December 31, 1995 increased to $2.2 million from $1.9 million in the year ended December 31, 1994 and $2.1 million in the year ended December 31, 1993. Research and development expense primarily reflects gen II and NexES development and development of additional primary antibodies. Selling, General and Administrative Presented below is a summary of the various components of SG&A expense and their respective percentages of net sales during the years ended December 31, 1995, 1994 and 1993.
YEAR ENDED DECEMBER 31, ----------------------------------------------------------------------- 1993 1994 1995 --------------------- --------------------- --------------------- $ % OF SALES $ % OF SALES $ % OF SALES ------ ---------- ------ ---------- ------ ---------- (DOLLARS IN THOUSANDS) Sales and marketing.............. $2,748 103% $4,843 81% $5,674 53% Administration................... 1,319 49% 2,056 35% 1,761 17% ------ ---------- ------ ---------- ------ ----- Total SG&A............. $4,067 152% $6,899 116% $7,435 70% ====== ======== ====== ======== ====== ========
SG&A expense in the year ended December 31, 1995 increased to $7.4 million from $6.9 million in the year ended December 31, 1994 and $4.1 million in the year ended December 31, 1993. The fluctuation in SG&A expense from period to period reflects the growth of Ventana's internal sales and marketing organization to facilitate its market expansion strategy and a corresponding increase in infrastructure expenses to support a larger business base. The growth in sales and marketing expense is the result of the decision by the Company to service the market through its own sales and marketing staff and costs needed to support sales growth during these periods. The increase in administrative expense is associated with the Company's regulatory strategy and costs associated with supporting an expanding business base. 25 28 INCOME TAXES Ventana and BioTek have neither provided for nor paid any federal income taxes since their respective inceptions because neither company generated taxable income in any fiscal year. At December 31, 1995, Ventana had net operating loss carryforwards for federal and state purposes of approximately $12.0 million. These federal and state carryforwards will begin to expire in 2000 and 1996 respectively, if not previously utilized. The Company also has research and development tax credit carryforwards of approximately $0.7 million which will begin to expire in 2005, if not previously utilized. Utilization of Ventana's net operating loss carryforwards will be subject to limitations due to the "change in ownership" provisions of the Internal Revenue Code of 1986, as amended (the "Code") as a result of the Company's prior issuances of equity securities. These carryforwards, therefore, may expire prior to being fully utilized. Future financings may cause additional changes in ownership and further limitations on the use of federal net operating loss carryforwards. Due to the losses incurred by Ventana since inception, deferred tax assets of approximately $8.6 million at December 31, 1995, related to these carryforwards, credits and temporary differences, have been fully reserved in accordance with Statement of Financial Accounting Standards No. 109, "Accounting for Income Taxes" ("FAS 109"). At December 31, 1995, BioTek had net operating loss carryforwards for federal and state purposes of approximately $10.8 million. These federal and state carryforwards will begin to expire in 2008, if not previously utilized. Utilization of BioTek's net operating loss carryforwards will be subject to limitations due to the change in ownership provisions of the Code as a result of the acquisition by Ventana. Therefore, these carryforwards may expire prior to being fully utilized. Due to the losses incurred by BioTek since inception, deferred tax assets of $5.7 million at December 31, 1995, related to these carryforwards, have been reserved in accordance with FAS 109. ACCOUNTING FOR STOCK-BASED COMPENSATION In October 1995, Statement of Financial Accounting Standards No. 123, "Accounting for Stock-Based Compensation" ("FAS 123"), was issued. FAS 123 is effective for the Company's 1996 financial statements. The Company intends to continue to account for employee stock options in accordance with APB Opinion No. 25 and will include the pro forma disclosures required by FAS 123 beginning in 1996. UNAUDITED PRO FORMA CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS The Company acquired BioTek for $18.8 million on February 26, 1996. The pro forma results of operations reflect the Company's operations as if it had acquired BioTek on January 1, 1994 and are adjusted to reflect the sale of 2,200,000 shares of Common Stock by the Company in this Offering and the application 26 29 of the net proceeds therefrom. The acquisition has been accounted for as a purchase. The composition of the consideration paid for BioTek and the preliminary allocation of the purchase price is presented below:
(IN THOUSANDS) The purchase price for BioTek consisted of: Cash consideration................................................... $ 2,500 Stock issued to BioTek noteholders................................... 3,007 Exchange Notes issued................................................ 8,978 Note payable -- escrow for contingencies............................. 234 Net historical liabilities assumed................................... 4,044 ----- Total purchase price......................................... $ 18,763 ===== The purchase price was allocated as follows: Tangible net assets.................................................. $ 2,288 In-process research & development.................................... 5,000 Goodwill............................................................. 1,875 Developed technology................................................. 2,000 Customer base........................................................ 4,200 Covenant not to compete.............................................. 1,800 Assembled work force................................................. 500 Trademark and trade names............................................ 1,100 ----- Total purchase price......................................... $ 18,763 =====
In accordance with FAS 2, the Company charged to expense at the date of the acquisition $5.0 million relating to the portion of the purchase price allocated to those in-process research and development projects where technological feasibility had not yet been established and where there are no alternative future uses. Upon closing of the acquisition, BioTek's revenue recognition policy was changed to adopt the Company's policy to record sales only upon the ultimate sale of products by CMS to end-users. The pro forma sales and related costs of goods sold, are adjusted as if BioTek had followed this policy beginning January 1, 1994. The combined effect of the pro forma change in accounting policy is an increase in net sales in both 1994 and 1995. This is primarily due to (i) shipments of instruments and reagents to CMS in 1993 and 1994 which were subsequently placed with end-users in 1994 and 1995 and (ii) sales being recorded at prices paid by the end-user as opposed to the net price paid by CMS. Accordingly, cost of goods sold has been adjusted to reflect the differences in the timing of sales and the mix of products sold, and selling expense has been increased to reflect the distribution commission paid to CMS. The commission is equal to the product of (i) the number of units shipped to end users and (ii) the difference between the price paid by the end-user to CMS and the net price paid by CMS. The pro forma financial results reflect cost savings associated with (i) consolidation of facilities (allocated to cost of goods sold (50%), research and development expense (10%), and selling, general, and administrative expense (40%)) and (ii) elimination of certain redundant selling and administrative positions. The pro forma financial results also reflect nonrecurring items including $5.0 million of acquired in-process research and development which was charged to expense (as discussed above) and $2.1 million of costs associated with the acquisition and integration of BioTek. These charges were incurred in the first quarter of 1996 and are reflected in the pro forma financial statements as if such charges had been incurred in the year ended December 31, 1994. Comparisons of pro forma results for the first quarter of 1996 to the first quarter of 1995 are not meaningful because Ventana's results of operations for the first quarter of 1996 include approximately one month of BioTek operations. 27 30 PRO FORMA RESULTS OF OPERATIONS YEARS ENDED DECEMBER 31, 1995 AND 1994 AND THREE MONTHS ENDED MARCH 31, 1996 AND 1995 Net Sales Presented below is a summary of pro forma consolidated revenue, instrument placements and instrument installed base for the years ended December 31, 1995 and 1994 and the three months ended March 31, 1996 and 1995.
YEAR ENDED DECEMBER 31, THREE MONTHS ENDED MARCH 31, --------------------------------- ------------------------------- 1994 1995 1995 1996 -------------- -------------- ------------- ------------- $ % $ % $ % $ % ------- ---- ------- ---- ------ ---- ------ ---- (DOLLARS IN THOUSANDS) REVENUE SUMMARY: Instruments........................... $ 5,798 47% $ 8,396 43% $2,040 46% $1,733 33% Reagents and other.................... 6,647 53% 11,079 57% 2,378 54% 3,495 67% ------- ---- ------- ---- ------ ---- ------ ---- Total revenue....................... $12,445 100% $19,475 100% $4,418 100% $5,228 100% ======= ==== ======= ==== ====== ==== ====== ====
THREE MONTHS YEAR ENDED ENDED MARCH DECEMBER 31, 31, ------------- ------------- INSTRUMENT PLACEMENTS (UNITS): 1994 1995 1995 1996 ---- ---- ---- ---- Patient priority: IHC/ES......................................................... 74 98 23 30 ISH/gen II..................................................... -- 15 5 3 --- --- --- --- Total patient priority...................................... 74 113 28 33 Batch processing................................................. 106 128 35 12 --- --- --- --- Total current placements.................................... 180 241 63 45 === === === === RAPs in current placements....................................... 19 22 8 6
DECEMBER 31, MARCH 31, ------------- ------------- 1994 1995 1995 1996 ---- ---- ---- ---- INSTRUMENT INSTALLED BASE (UNITS): Patient priority: IHC/ES......................................................... 148 246 174 276 ISH/gen II..................................................... -- 15 2 18 --- --- --- --- Total patient priority...................................... 148 261 176 294 Batch processing................................................. 147 275 182 287 --- --- --- --- Total instrument installed base............................. 295 536 358 581 === === === === RAPs in installed base........................................... 44 66 52 72
Total consolidated pro forma net sales increased 57% in 1995 as compared to 1994 and 18% during the first quarter of 1996 as compared to the first quarter of 1995. The increase in net sales resulted from increased instrument placements and reagent sales by both companies. Consolidated pro forma instrument sales increased 45% during 1995 as compared to 1994 and declined 15% during the first quarter of 1996 compared to the first quarter of 1995. Despite increased international unit sales by BioTek, the increase in pro forma instrument sales in 1995 was less than that experienced by Ventana due to lower average selling prices on European units and a decrease in United States instrument placements by BioTek. Pro forma instrument placements and sales during the fourth quarter of 1995 and first quarter of 1996 were adversely affected by BioTek's inability to procure instruments due to insufficient working capital. BioTek instruments sold internationally by DAKO, which compose approximately 40% of BioTek's installed base of instruments, generate recurring royalty income from DAKO in exchange for DAKO's right to supply such customers with reagents. Pro forma reagent sales increased 67% during 1995 as compared to the 79% reagent sales growth experienced by Ventana during the same time period. Pro forma reagent sales growth in 1995 was less than Ventana's because BioTek's installed base of instruments shifted towards 28 31 European placements and such placements generated a fixed royalty income stream which is less per instrument than the recurring reagent revenue stream associated with United States placements. Gross Margin Pro forma gross profit in the quarter ended March 31, 1996 increased to $3.3 million from $2.3 million in the quarter ended March 31, 1995 and increased to $10.4 million in the year ended December 31, 1995 from $6.6 million in the year ended December 31, 1994. Pro forma gross margin increased to 63% in the quarter ended March 31, 1996 from 52% in the quarter ended March 31, 1995. Pro forma gross margin was 53% in each of the years ended December 31, 1995 and 1994. Pro forma gross margins are lower than Ventana's stand-alone gross margins because BioTek's margins are adversely affected by BioTek's (i) use of contract manufacturers and third-party distributors, (ii) lower value-added reagent manufacturing strategy and (iii) lower reagent volumes and pricing due to the open configuration of BioTek's instruments. Research and Development Pro forma research and development expense was approximately equal in the quarters ended March 31, 1996 and 1995. Pro forma research and development expense in the year ended December 31, 1995 increased to $4.4 million from $2.7 million in the year ended December 31, 1994. Pro forma research and development expense reflects increased expenditures by Ventana to support the development of new instruments and reagents including the gen II, the NexES and primary antibodies. These expenditures also reflect BioTek's development of the TechMate 250 instrument and an ISH oven. During 1995 and the first quarter of 1996, BioTek reduced its research and development expenditures primarily due to working capital constraints. Selling, General and Administrative Pro forma SG&A expense increased to $2.7 million in the quarter ended March 31, 1996 from $2.4 million in the quarter ended March 31, 1995 and increased to $11.0 million in the year ended December 31, 1995 from $9.9 million in the year ended December 31, 1994. Pro forma SG&A expense reflects increased expenditures to expand sales and marketing capabilities in the United States and Europe and increased administrative expenditures to support higher manufacturing and sales volumes. SG&A expenditures at BioTek were limited due to BioTek's working capital constraints and its use of third-party distributors in the United States and Europe. 29 32 QUARTERLY PRO FORMA CONSOLIDATED RESULTS OF OPERATIONS The following table contains summary unaudited quarterly pro forma consolidated statements of operations data for the five quarters ended March 31, 1996. Management has prepared the quarterly pro forma consolidated statements of operations data on the same basis as the Unaudited Pro Forma Condensed Consolidated Statements of Operations contained in this Prospectus. The Company's results of operations have varied and may continue to fluctuate significantly from quarter to quarter. Results of operations in any period should not be considered indicative of the results to be expected for any future period. SUMMARY UNAUDITED QUARTERLY PRO FORMA CONDENSED CONSOLIDATED FINANCIAL AND OPERATING DATA (DOLLARS IN THOUSANDS, EXCEPT PER SHARE DATA)
THREE 1995 MONTHS ------------------------------------- ENDED FIRST SECOND THIRD FOURTH MARCH 31, QUARTER QUARTER QUARTER QUARTER 1996 ------- ------- ------- ------- --------- STATEMENT OF OPERATIONS DATA: Sales: Instruments................................... $ 2,040 $ 2,148 $ 2,461 $ 1,747 $ 1,733 Reagents and other............................ 2,378 2,484 2,931 3,286 3,495 ------- ------- ------- ------- ------- Total net sales....................... 4,418 4,632 5,392 5,033 5,228 Cost of goods sold.............................. 2,134 2,236 2,438 2,288 1,927 ------- ------- ------- ------- ------- Gross profit.................................... 2,284 2,396 2,954 2,745 3,301 Operating expenses: Research and development...................... 721 1,815 1,002 869 771 Selling, general and administrative........... 2,367 3,130 2,675 2,796 2,704 ------- ------- ------- ------- ------- Loss from operations before amortization of intangibles................................... (804) (2,549) (723) (920) (174) Amortization of intangibles..................... (336) (336) (336) (336) (336) ------- ------- ------- ------- ------- Loss from operations............................ (1,140) (2,885) (1,059) (1,256) (510) Interest income (expense)....................... 50 37 25 (38) (5) ------- ------- ------- ------- ------- Net loss........................................ $(1,090) $(2,848) $(1,034) $(1,294) $ (515) ------- ------- ------- ------- ------- Pro forma net loss per share(1)................. $ (0.12) $ (0.30) $ (0.11) $ (0.14) $ (0.05) ======= ======= ======= ======= ======= Pro forma shares used in computing net loss per share(1).................................. 9,331 9,453 9,525 9,551 9,696 ======= ======= ======= ======= ======= OPERATING DATA: Instrument placements (Units): Patient priority (Ventana).................... 28 23 30 32 33 Batch processing (BioTek)..................... 35 38 39 16 12 ------- ------- ------- ------- ------- Total annual placements............... 63 61 69 48 45 ======= ======= ======= ======= ======= Instrument installed base (Units): Patient priority (Ventana).................... 176 199 229 261 294 Batch processing (BioTek)..................... 182 220 259 275 287 ------- ------- ------- ------- ------- Total installed base.................. 358 419 488 536 581 ======= ======= ======= ======= =======
- --------------- (1) Pro forma shares used in computing pro forma net loss per share are adjusted to reflect the sale of 1,112,000 shares of Common Stock by the Company in this Offering to repay acquisition debt. LIQUIDITY AND CAPITAL RESOURCES Since inception, the Company's expenses have significantly exceeded its net sales, resulting in an accumulated deficit of $29.4 million at March 31, 1996. The Company has funded its operations primarily through the private placement of approximately $31.6 million of equity and debt securities. At March 31, 1996, the Company's principal source of liquidity consisted of cash and cash equivalents of $3.4 million and available borrowing capacity under the Company's bank credit facility. 30 33 Net cash flow from operating activities during the three months ended March 31, 1996 and 1995 was approximately $(0.9) million and $(0.4) million, respectively. Net cash flow from operating activities was approximately $(2.9) million, $(5.3) million and $(5.1) million for the years ended December 31, 1995, 1994 and 1993, respectively. Net cash flow from operating activities during these periods primarily reflects the Company's operating losses. Net cash flow from investing activities was $(2.6) million and $(0.4) million for the three months ended March 31, 1996 and 1995, respectively. The Company expended $2.5 million in cash as part of the consideration for the purchase of BioTek in the three months ended March 31, 1996. Net cash flow from investing activities (excluding sales or purchases of short-term investments) was approximately $(1.0) million, $(0.6) million and $(1.7) million for the years ended December 31, 1995, 1994 and 1993. Net cash flow from investing activities was primarily used for capital expenditures to increase manufacturing capacity and to upgrade management information systems. Net cash flow from financing activities was $5.7 million and $2.4 million for the three months ended March 31, 1996 and 1995, respectively. Net cash flow from financing activities was $2.6 million, $3.0 million and $5.1 million for the years ended December 31, 1995, 1994 and 1993, respectively. Net cash flow from financing activities was primarily the result of private placements of equity securities. During the quarter ended March 31, 1996, the Company raised $4.6 million through the private placement of subordinated notes which included warrants to purchase an aggregate of 879,183 shares of Common Stock of the Company at an exercise price of $5.82 per share. The proceeds of these notes were used to fund the cash portion of the BioTek acquisition consideration and to provide working capital. These notes bear interest at 7% per annum, which will be forgiven if the notes are repaid prior to December 31, 1996. The subordinated notes are required to be repaid by the Company within 30 days of the completion of this Offering. The Company also has a credit facility with a bank lender which consists of a term loan facility of $2.0 million and a revolving line of credit of $2.7 million. The term loan and the revolving line of credit bear interest at the lender's prime rate plus 2.0% per annum and mature in 1999. The revolving line of credit permits the Company to borrow up to a specified percentage of eligible accounts receivable. The credit facility is secured by a pledge of substantially all of the Company's assets and is subject to certain financial covenants, including certain financial ratios and dividend restrictions. At March 31, 1996, the Company had borrowed $1.0 million under the revolving credit line which was subsequently converted to a term loan. Subsequent to March 31, 1996, the Company borrowed an additional $1.0 million under the term loan facility. The Company plans to repay the entire $2.0 million balance of the term loan with the net proceeds of this Offering. In 1994, the Company arranged, on a non-recourse basis, for third-party lease financing for instrument purchases by customers. To date, this program has generated 12 non-recourse leases and has had a small positive net cash flow impact for the Company. In connection with the acquisition of BioTek, Ventana issued an aggregate of $12.2 million in exchange notes (collectively, the "Exchange Notes") to the holders of outstanding indebtedness of BioTek. The Exchange Notes bear interest at the rate of 7% per annum which will be forgiven if the Exchange Notes are repaid prior to December 31, 1996. The Exchange Notes provided each holder with the opportunity, during a 30-day period, to convert Exchange Notes into shares of Ventana Common Stock at a conversion price of $13.53 per share. Upon expiration of the conversion period, an aggregate of $3.0 million in principal amount of Exchange Notes were converted into 225,100 shares of Common Stock and an aggregate of $9.2 million of Exchange Notes remained outstanding. These Exchange Notes are due and payable 30 days after the completion of this Offering and will be repaid with the net proceeds of this Offering. In connection with BioTek's agreement with DAKO, DAKO made two loans secured by a pledge of substantially all of BioTek's assets. DAKO also made prepayments on future instrument sales and reagent royalties to BioTek. These loans and prepayments were used to fund TechMate 250 instrument development and working capital requirements. The aggregate balance of the secured loans and prepayments was $1.6 million and $0.9 million, respectively, at March 31, 1996. Of the secured loans, $0.3 million bear interest 31 34 at 5% per annum and the remaining $1.3 million does not bear interest. The prepayments do not bear interest. The secured loans and prepayments are recorded as advances from distributor in the Company's Consolidated Financial Statements. The loans are repaid through discounts on DAKO's purchases of instruments from BioTek. Upon termination of the distribution agreement or in the event of a default by BioTek under the distribution agreement, these loans will convert to fixed term loans that will be due and payable in 12 equal quarterly installments commencing upon such event. See "Business -- Sales, Marketing and Customer Support." The Company believes that the anticipated net proceeds from this Offering together with its existing capital resources, and interest earned thereon, will be sufficient to satisfy its working capital requirements through at least 1997. The Company's future capital requirements will depend on many factors, including the extent to which the Company's products gain market acceptance, the mix of instruments placed through direct sales or RAPs, progress of the Company's product development programs, competing technological and market developments, expansion of the Company's sales and marketing activities, the cost of manufacturing scale-up activities, possible acquisitions of complementary businesses, products or technologies, the extent and duration of operating losses and timing of regulatory approvals. The Company may be required to raise additional capital in the future through the issuance of either equity securities or debt instruments or both. There is no assurance such capital will be available to the extent required by or on terms acceptable to the Company or at all. 32 35 BUSINESS OVERVIEW Ventana develops, manufactures and markets proprietary instrument/reagent systems that automate IHC and ISH tests for the analysis of cells and tissues on microscope slides. These tests are important tools used in the diagnosis of and selection of treatment for cancer. The Company believes that it is the worldwide leader in the automated IHC testing market, as the Company estimates that its worldwide installed base of 581 instruments as of March 31, 1996 is approximately five times as large as the combined installed base of instruments of all of the Company's current competitors. Ventana has placed instruments with 31 of the 40 leading cancer centers according to U. S. News & World Report and 35 of the 42 cancer centers designated by the National Cancer Institute, including the Mayo Clinic, the Dana Farber Cancer Institute, The Johns Hopkins University, the M.D. Anderson Cancer Center and the Fred Hutchinson Cancer Center. Each Ventana proprietary system placed provides a recurring revenue stream as customers consume reagents and supplies sold by the Company with each test conducted. Consequently, two key elements of the Company's strategy are to increase the number of instrument placements and to maximize the recurring revenue stream per placement through increased sales of reagents and supplies. In late 1991, Ventana began commercial shipment of its first system, the Ventana 320 instrument and related reagents used for automated IHC tests. Since then, Ventana has developed and introduced the Ventana ES, the successor to the 320, as well as the Ventana gen II, which is capable of performing ISH tests in addition to IHC tests. These patient priority systems use Ventana's proprietary horizontal slide processing technology to perform multiple tests rapidly on a single patient biopsy. In February 1996, Ventana acquired BioTek which introduced its first automated IHC system, the TechMate 1000, in 1992, and has also introduced the successor TechMate 500 instrument. BioTek's batch processing systems use proprietary vertical slide processing technology to reliably and cost effectively process high volumes of single tests on multiple patient biopsies. These complementary product lines enable Ventana to serve a broad range of customers. Smaller hospitals, which generally do not handle a high volume of cancer patients, typically use patient priority systems to meet their automated testing needs. Reference and research laboratories which serve numerous institutions typically use batch processing systems to process large volumes of tests. Large hospitals with a high volume of patients and a broad range of test requirements may use both patient priority and batch processing systems. Cancer is the second leading cause of death in the United States accounting for 25% of deaths (approximately 555,000 deaths per year). Currently, approximately 10 million people in the United States have a history of invasive cancer, and it is estimated that approximately 1.4 million new cases of invasive cancer will be diagnosed each year. The vast majority of IHC testing associated with cancer diagnosis and treatment in the United States is conducted in an aggregate of approximately 2,200 clinical institutions and reference and research laboratories. The Company estimates that these institutions and laboratories create the opportunity for the placement of as many as 2,500 automated IHC testing instruments. The Company believes that less than 20% of such institutions and laboratories currently conduct IHC testing on an automated basis. The international market for automated IHC and ISH testing is estimated by the Company to be approximately 1.2 times the size of the United States market with Europe accounting for approximately 55% of the international market potential. Currently most IHC testing is performed manually which often yields inconsistency of test results. As compared to manual IHC testing, Ventana's automated systems provide improved reliability, reproducibility and consistency of test results. The systems' economic advantages include reduced cost per test, faster turnaround time, increased test throughput and a reduced dependence on skilled laboratory technicians. Additional benefits include the ability to perform new and emerging diagnostic tests, improved visual clarity which aids the interpretation of test results, and the ability to obtain maximum clinical information from minimally sized biopsies. The Company believes it will play a critical, expanding role in cancer science as researchers will use Ventana systems to accelerate the identification and development of new tests and that its installed base of instruments will speed the commercialization and clinical implementation of such new tests. 33 36 The Company anticipates that its reagent test menu will expand due to the major emphasis of cancer research on the identification of new prognostic IHC and ISH indicators. ACQUISITION OF BIOTEK Ventana acquired BioTek in February 1996 for total consideration of $18.8 million. The acquisition of BioTek enhanced Ventana's competitive position and enabled the Company to become the worldwide leader in the automated IHC and ISH testing market. Ventana's installed base of instruments increased from 294 instruments to 581 instruments as of March 31, 1996 as a result of the acquisition. The increase in the instrument base also increased the aggregate recurring revenue stream from reagents and supplies sold to customers. The acquisition also enabled Ventana to add a number of prestigious cancer centers to its list of customers. BioTek's product line complements Ventana's and enables the Company to meet the differing needs of customers requiring patient priority or batch processing systems, or both. The acquisition also creates the opportunity for operational synergies including the change to higher value-added and consolidation of reagent manufacturing, the rationalization of sales and marketing forces and the elimination of redundant regulatory, general and administration functions and personnel. Historically, BioTek generated lower gross margins than Ventana due to its employment of a different business strategy which primarily involved the use of third parties for key activities. BioTek's instruments were produced by third-party manufacturers which prevented BioTek from capturing manufacturing margin. BioTek's instruments have an open configuration, enabling the customer to use reagents purchased from BioTek or others, which impacted both the price and volume of reagents purchased by customers from BioTek. In contrast, Ventana's instruments have a closed configuration requiring the customer to use Ventana's prepackaged detection chemistries. BioTek also realized lower gross margins on reagents than Ventana due to its utilization of intermediate materials in the manufacturing process which resulted in the capture of fewer value-added steps. BioTek used DAKO and CMS as third-party distributors in the United States and international markets, respectively, and supported its United States sales efforts with field sales and technical support personnel. As a result, BioTek experienced both lower gross margins than if it had sold its products directly and a higher level of selling expense than typically incurred in conjunction with third-party distribution arrangements. Ventana's goal is to integrate the operations of BioTek into the Ventana business model, in which manufacturing, sales and marketing activities are performed by Company employees. In May 1996, the Company completed the integration of the BioTek and Ventana direct field sales and technical personnel. The Company does not intend to renew the United States distribution agreement with CMS which expires in April 1998. The Company is engaged in discussions with DAKO regarding various aspects of the distribution arrangement, which expires in December 1999. The Company expects to complete the consolidation of BioTek's reagent manufacturing into Ventana's Tucson facilities in September 1996. Following this consolidation, the Company intends to convert BioTek's reagent manufacturing to the process used by Ventana in which basic raw materials are used and important value-added steps are performed internally. The Company believes that in the near term it will be more cost effective to continue sourcing batch processing instruments from third-party manufacturers. The Company expects to complete a contract manufacturing agreement with Kollsman for the TechMate 500 instrument and has entered into an agreement with LJL for production of the Company's next generation batch processing instrument, the TechMate 250. INDUSTRY BACKGROUND IMMUNOHISTOCHEMISTRY Cancer is the second leading cause of death in the United States accounting for 25% of deaths (555,000 deaths per year). Currently, approximately 10 million people in the United States have a history of invasive cancer, and it is estimated that approximately 1.4 million new cases will be diagnosed each year. In the United States, the lifetime risk of developing invasive cancer is 47% for males and 38% for females. The risk of developing cancer increases with age. Among the principal forms of cancer are leukemia, lymphoma and cervical, breast, urinary, lung, prostate, ovarian, colon and rectal cancer. 34 37 Early detection is the number one factor in increasing the long term survival of cancer patients. Health care professionals are increasing their emphasis on and use of screening and early detection programs for cancer because cancer treatments are generally significantly more effective and less costly the earlier that cancer is detected. Complementing screening and early detection are recent advances in less invasive biopsy methods that can obtain tissue samples from progressively smaller tumors. As a result of these developments, there has been a steady increase in the initial diagnosis of invasive cancer. However, smaller tissue samples are often difficult to analyze with traditional diagnostic tests, increasing the dependence of surgical pathologists on IHC for accurate diagnosis of early stage cancer. After preliminary screening of a biopsy to determine the presence of cancer, IHC is the principal diagnostic test method used for cancer diagnosis and therapy selection. IHC tests use specific antibodies to identify and detect antigens (proteins) in cells and tissues which assist pathologists in assessing various aspects of a patient's cancer. IHC tests, or assays, have two major components: primary antibodies and detection chemistries. The primary antibody is the specific antibody used to bind to the antigen in question. Detection chemistries are composed of multiple reagents including secondary antibodies, enzyme conjugates/complexes and chromogenic enzyme substrates which allow visualization of the primary antibody. IHC tests are performed on cells and tumor tissue to: - determine the type of cancer - determine the site of the primary tumor - determine the degree of malignancy - determine if the cancer has metastasized - assist in the selection of the most appropriate therapy - monitor patient progress - develop a prognosis Correct prognosis is essential in selecting the appropriate therapy regimen and monitoring program for individual cancer patients. IHC assays provide significant prognostic information such as cell cycle and hormone receptor status which, in many cases, cannot be obtained from other tests. This information allows the pathologist to improve risk assessment on an individual patient basis. IHC testing is therefore instrumental to controlling and reducing health care costs and improving cancer survival rates because earlier, more accurate diagnoses and prognoses can lead to earlier, more targeted therapy and may reduce the risk of use of an incorrect or inappropriate treatment. Manual IHC assays require skilled technical personnel to perform as many as 60 individual processes and can require several days to complete. For the assay to be successful, each process must be performed in the proper sequence and for the proper length of time. In addition, the length of time and the reagents used for each of the steps varies depending upon the primary antibody used in the assay. The complexity of manual IHC assays leads to poor reproducibility and inconsistency of results. Therefore, while IHC has been used routinely in clinical diagnosis for over 10 years, the requirement of skilled technical personnel, labor intensity (approximately 40 slides per day per technician) and lack of standardization has limited the growth of clinical IHC. The development of new diagnostic systems composed of instruments and reagents has resulted in the automation of tests in a number of diagnostic market segments. The trend toward automation of diagnostic testing began in the 1960s with the automation of hematology testing by Coulter Electronics Corporation and clinical chemistry testing by Technicon Instruments Corporation. In the 1980s, Abbott Laboratories, Inc. ("Abbott") introduced two instruments with proprietary prepackaged reagents to automate immunoassay tests performed on serum or urine. Ventana's systems are fundamental enabling technologies that overcome major obstacles, including the inherent limitations of manual processing, which have historically prevented both the broader use and growth of IHC. 35 38 IN SITU HYBRIDIZATION ISH tests are advanced tests for infectious disease and cancer diagnosis and other applications that generate visual signals based on probes used to detect the presence of specific nucleic acids (DNA/RNA) contained in a cell. Over the next decade, Ventana believes that ongoing research and development in the field of molecular analysis will result in the continued introduction of new IHC and ISH tests. ISH assays are technically far more challenging and labor intensive than IHC assays. In addition to requiring a similar number of processes which must be performed in the proper sequence and for the proper length of time, ISH assays require multiple wash solutions, or buffers, and the temperature at which each of the steps must be executed typically ranges from 37(++)C to 98(++)C. Furthermore, the conditions for each of these processes is dependent upon the specific probe being used. Due to this extreme degree of technical difficulty, there are very few clinical laboratories capable of performing manual ISH assays. Ventana's gen II system represents a fundamental enabling technology for the rapid, accurate and cost effective identification of unique RNA and DNA (probe diagnostics) and is designed to overcome the inherent limitations of manual processing. VENTANA STRATEGY The Company's objective is to strengthen its worldwide leadership position in the automated IHC testing market and to develop and expand the automated ISH testing market. The following represent key elements of the Company's strategy: Maximize Instrument Placements. The Company's objective is to strengthen its competitive position in the automation of IHC testing by establishing a larger installed base of instruments that current or future market entrants must overcome. The Company estimates that its worldwide installed base of 581 instruments is approximately five times as large as the combined installed base of instruments of all of the Company's current competitors. The Company believes that its placement of instruments in 35 of the 42 cancer centers designated by the National Cancer Institute provides a powerful reference tool for potential new customers. To facilitate instrument placements, the Company offers customers a wide selection of instruments which address the patient priority needs of hospital clinical laboratories and the batch processing needs of large hospitals and reference and research laboratories. In order to satisfy the broad spectrum of customers' operational and financial criteria, the Company intends to continue to offer several instrument procurement options, including RAPs, and to expand the range and price points of its instrument offerings. Under a RAP, the customer obtains the use of an instrument with no capital investment in exchange for the customer's commitment to purchase reagents from the Company at a higher price than if the instrument had been purchased. The Company believes it can accelerate the rate of expansion of its installed base by increasing its emphasis on the placement of instruments through RAPs because the required capital investment associated with a purchase, a significant sales hurdle, will be eliminated. Maximize Revenue Stream Per Placement. Each instrument placed provides the Company with a recurring revenue stream through the sale of reagents and supplies. The Company seeks to increase this revenue stream by converting all existing manual tests performed by the customer to full automation and by selling to the customer all reagents required for such tests. The Company then seeks to have the customer expand its test menu through the inclusion of all tests that are offered by Ventana as well as new tests as they are introduced. To meet these objectives, the Company's systems have been designed as broad enabling platforms which permit customers to easily expand their test menu. The Company also has a comprehensive customer education program which includes on-site technical training in instrument use, user group meetings and Company-sponsored national teleconferences with leading medical experts who regularly update customers on diagnostic and testing developments. Develop New and Enhanced Products. Since 1991, the Company has successfully introduced and commercialized the Ventana ES, the Ventana gen II and the TechMate 500, as well as 48 new reagents. The Company intends to introduce lower priced instruments which it expects it will place through RAPs in order to provide greater financial flexibility for its customers in instrument procurement. Ventana recently initiated broad-scale commercialization of its gen II ISH system and has placed 15 systems in leading research sites in 36 39 the United States and Europe. The Company intends to continue to innovate in the field of automated cellular diagnostics through the development and introduction of new instruments, software and reagents. Expand Intellectual Property Position. The Company seeks to expand its intellectual property position by entering into strategic alliances, acquiring rights of first refusal on future commercial developments and licensing existing technologies. The Company evaluates and intends to pursue the licensing of nucleic acid probe technology for ISH applications from biopharmaceutical companies, research institutions and others. In conjunction with gen II system placements, the Company has and continues to enter into agreements with customers which provide the Company with a right of first refusal to commercialize new tests developed by such customers for use on the gen II system. The Company believes customers are willing to enter into these arrangements because the gen II is an enabling platform that facilitates the development and commercialization of new ISH tests. PRODUCTS The Company offers proprietary systems composed of instrumentation, reagents and consumable products which are designed to enable clinical and research laboratories to perform standardized IHC and ISH testing. The proprietary nature of the Company's systems is based upon the interrelationship among the electronics and mechanical and software control of the instrument and the stabilization, composition, packaging and delivery of reagents. The Company's broad line of products includes patient priority systems targeted to hospital clinical laboratories and batch processing systems targeted to large hospital clinical laboratories and reference and research laboratories. The Company's patient priority systems are "closed" in that customers must purchase detection chemistries from Ventana in order to operate the instruments. Although the Company's existing batch processing systems are "open," providing the customer with the ability to purchase reagents from either the Company or other sources, users of more than 85% of the Company's United States installed batch processing systems regularly purchase reagents from the Company. The following are the principal benefits of automated cellular and tissue analysis using the Company's integrated systems as compared with manual methods: - improved reliability, reproducibility and consistency of test results - reduced cost per test - faster turnaround time for test results - increased test throughput for the testing laboratory - ability to perform new and emerging molecular tests - reduced dependence on skilled laboratory technicians - ability to perform special staining applications (batch processing instruments) - ability to obtain maximum clinical information from minimally-sized biopsies - ability to document processing protocols (patient priority instruments) - enhanced cellular differentiation through multiple staining on a single slide To confirm the cost advantages of automated analysis using the Company's instruments as compared to manual methods, the Company completed a cost study involving 11 representative users of the Company's systems. These users encompass a cross-section of the Company's customers and include hospitals of varying sizes and a reference laboratory. The cost data compiled in the study was based on the users' internal allocations of IHC test costs. The results of the study indicate that automated IHC analysis using the Company's products results in cost savings per test of approximately 10% as compared to manual methods. INSTRUMENT PRODUCTS Patient Priority Instruments. Ventana currently offers two patient priority systems, the Ventana ES and the Ventana gen II. The Ventana patient priority systems provide a complete automated approach, requiring users to only prepare specimens and place them on microscope slides. The patient priority systems are barcode driven and are designed for multiple tests on a single patient biopsy with rapid turnaround time and walk-away convenience. A barcode label affixed to each slide positively identifies the slide and the test procedures to be 37 40 performed. Up to 40 slides can be processed at one time in the reaction chamber of the instrument utilizing as many as 25 individual reagents, providing the user with significant flexibility. The instrument scans the barcodes on the slides and the reagent dispensers and processes each slide with the unique steps necessary to perform each test. The Company's proprietary software controls all aspects of the test procedures. The steps of dispensing, incubating (i.e. temperature and time control) and washing are performed by the instrument using a series of proprietary chemical/mechanical methods developed by Ventana. These methods are critical to obtaining precise, sensitive and rapid test results and make the system reliable and easy to use. Typically, the processing of slides on the instrument requires less than two hours. The Ventana gen II uses the same basic architecture as the Ventana ES instrument and has additional functions enabling it to perform ISH tests. These functions are (i) an improved heating system which allows for incubation temperatures of up to 98(++)C, (ii) rapid incubation temperature cycling and (iii) additional and improved wash stations which permit the use of multiple buffers and instrument controlled changes in the concentration of buffers. Ventana's gen II system represents a fundamental enabling technology for the rapid, accurate and cost effective identification of unique RNA and DNA (probe diagnostics) and is designed to overcome the inherent limitations of manual processing. The Company is currently in the process of developing a new IHC instrument, the NexES. The NexES, a patient priority system having IHC capabilities similar to the Ventana ES, will be offered at a lower price per unit than the ES. Unlike the Ventana ES, the NexES is based upon a modular design and an external personal computer with a Windows 95 operating environment for software control. Each module holds up to 20 slides in the reaction chamber and 25 reagents in its reagent carousel. The modular design of the NexES and external personal computer will permit the linkage of up to eight NexES modules together, creating the capacity to process up to 160 slides using up to 200 reagents at one time. The NexES will therefore offer users a significant degree of flexibility as users can purchase from one to eight modules depending upon their test volume requirements. Initial prototypes of the NexES are currently at the in-house testing stage with beta site testing scheduled for early 1997. Commercial introduction of the NexES is currently scheduled for 1997. Batch Processing Instruments. The Company's line of TechMate batch processing instruments are designed for large volume testing using a single antibody on multiple patient biopsies and research applications in which long incubation times and unique detection chemistries are required. The Company's batch processing instruments employ capillary action to perform IHC tests. Patient biopsies are placed on capillary gap slides which maintain a space of predetermined width between adjacent slides when loaded into TechMate systems. Reagents are loaded into disposable reagent trays and programmable software directs the instrument to apply the reagents in the proper sequence. The instrument immerses the bottoms of the slides in the reagents as programmed and the reagents are drawn up the slide and over the tissue specimen by capillary action. After each reagent application and incubation, the instrument removes the reagent from the specimen by placing the slides onto disposable blotting pads. The Company's original batch instrument, the TechMate 1000, has a 300 slide capacity. This large capacity is suited to large reference laboratories which run a limited number of antibody tests on vast numbers of patient biopsies. The Company has ceased production of the TechMate 1000. The successor instrument, the TechMate 500, has a 120 slide capacity, which is applicable to both large and moderately-sized reference laboratories and large research laboratories. The Company has completed development of, and through LJL is initiating production of, the TechMate 250 instrument. The TechMate 250, which has a 40 slide capacity, is targeted primarily for the European market. REAGENT AND CONSUMABLE PRODUCTS Reagent Products Reagent products are composed of primary antibodies and detection chemistries, each of which is required for an IHC test. Customers that have patient priority systems must use Ventana detection chemistries on all tests; such customers have the option of purchasing primary antibodies from Ventana or other sources. Customers who have the Company's batch processing systems have the option of purchasing both antibodies and detection chemistries from Ventana or other sources. Users of more than 85% of the Company's United States installed batch processing systems regularly purchase reagents from the Company. 38 41 Primary Antibodies. Ventana sells a line of in excess of 30 primary antibodies used to detect antigens in combination with detection chemistry kits on the Company's instruments. Ventana markets all of the antibodies used to perform the IHC tests that currently account for approximately 85% of total IHC test volume. Detection Kits. Detection chemistries typically account for approximately 70% of the total expenditures for reagents required to perform IHC tests using the Company's instruments. Ventana produces a line of detection chemistries for use on both patient priority and batch processing systems which provide the user with standardized reagents, thereby giving the user convenient and rapid results. The detection chemistries have been developed by the Company using proprietary formulations which, when combined with the Company's primary antibodies and other reagents, optimize the results of tests performed on the Company's instruments. These kits generate the visual signal in an IHC reaction at the site where a primary antibody is bound to a specific antigen or molecule in the cell or tissue. The patient priority system utilizes detection kits which include (i) a DAB Kit which generates a brown color; (ii) an AEC Kit which generates a deep red color; (iii) an AlkPhos Red Kit which generates a bright red color; and (iv) an AlkPhos Blue Kit which generates a deep blue color. The Company currently sells DAB and AlkPhos Red for use with its batch processing instruments. The detection kits are designed to perform tests on a wide variety of specimens, so a laboratory can, for example, perform tests on tissue preserved in paraffin and on frozen tissue simultaneously. The Company's detection chemistries have been formulated to provide long term stability for reproducibility and ease of use as well as a high signal to noise ratio for optimal sensitivity. Consumable Products Ventana offers a line of consumable ancillary products that are necessary for processing slides on the Company's instruments. These include buffers for optimizing the IHC reaction and counterstains for staining cell nuclei, which are used with both patient priority and batch processing instruments. The buffers ensure good morphology, low backgrounds and high signals. The counterstains provide additional convenience for the customer by eliminating the need for additional processing of the slides after staining on the instrument. For use with patient priority instruments, Ventana also supplies a proprietary liquid coverslip which is used to inhibit evaporation during processing in the instrument, fixatives for maintaining the morphology of cells or tissues, enzymes for unmasking antigens, and slide barcodes for use in identifying the slide and its specific IHC reaction steps. For use with batch processing instruments, the Company also provides disposable reagent trays which are used to hold the reagents during IHC reactions, capillary gap slides and wicking pads used for reagent removal between applications. MARKETS AND CUSTOMERS There are approximately 4,200 acute care hospitals and clinics in the United States. Of these, there are approximately 1,900 hospitals with over 200 beds which perform the vast majority of surgical and other medical procedures related to cancer diagnosis and treatment. In addition, there are approximately 200 reference and research laboratories and approximately 100 biotechnology and pharmaceutical companies which also perform substantial numbers of IHC and ISH tests. The combination of these health care institutions creates a total instrument site potential of 2,200 locations. Ventana considers this to be its core market segment for cancer testing and focuses the bulk of its sales and marketing efforts on these institutions. The Company estimates there are as many as 2,500 instrument placement opportunities in the 2,200 potential instrument site locations in the United States. The international market for instrument placements is estimated by the Company to be approximately 1.2 times the size of the United States market. Europe is estimated to account for approximately 55% of the international market potential, Japan approximately 20% and the Pacific Rim and Latin American markets the balance of the international market opportunity. As of March 31, 1996, the Company had 441 instrument placements in 406 of the 2,200 potential United States instrument sites. The Company believes that less than 25% of such United States potential instrument sites currently conduct IHC testing on an automated basis. The Company believes that its worldwide installed base of 581 instruments is approximately five times as large as the combined installed base of instruments of all of the Company's current competitors. 39 42 Ventana has placed instruments with 31 of the top 40 cancer centers according to U.S. News & World Report and 35 of the 42 cancer centers designated by the National Cancer Institute, including the Mayo Clinic, the Dana Farber Cancer Institute, The Johns Hopkins University, the M.D. Anderson Cancer Center and the Fred Hutchinson Cancer Center. Presented below is a selected list of existing customers: HOSPITALS AND CLINICS Albany Medical Center Hospital (3 units) Baylor School of Medicine Boston University City of Hope National Medical Center (3 units) Cleveland Clinic (3 units) Columbia Presbyterian Dana Farber Cancer Institute Fox Chase Cancer Center Fred Hutchinson Cancer Center (2 units) Georgetown University (2 units) Harvard University Medical School (2 units) The Johns Hopkins University (2 units) REFERENCE AND RESEARCH LABORATORIES Corning Nichols/MetPath (2 units) Dianon (2 units) National Cancer Institute National Institutes of Health (5 units) M.D. Anderson Cancer Center (2 units) Mayo Clinic (4 units) New York University (2 units) Northwestern University Ochsner Clinic Stanford University UCLA Medical Center University of Chicago (4 units) University of Michigan (4 units) Walter Reed Army Medical Center (2 units) Yale University BIOTECHNOLOGY AND PHARMACEUTICAL Amgen, Inc. (2 units) Bristol-Myers Squibb Company Eli Lilly and Company Prizm Pharmaceuticals Schering-Plough Corporation The Company intends to introduce lower priced instruments, including the NexES and the TechMate 250, which it expects to place through RAPs in order to provide greater financial flexibility for its customers in equipment procurement. The Company believes that lower priced systems and the RAP program will have particular appeal to those hospitals which are currently losing reimbursement revenue and incurring increased costs as a result of not performing IHC tests internally. Additionally, smaller hospitals can benefit from the Company's RAP programs and lower priced instruments due to the absence of an initial capital expenditure and an increased ability to compete with larger hospitals by providing IHC testing and consultation on site. SALES, MARKETING AND CUSTOMER SUPPORT Ventana markets and sells its instruments and reagents in North America through a direct sales force and CMS. The Company markets and sells its instruments and reagents in Europe through a direct sales organization headquartered in Strasbourg, France, distribution relationships in certain countries and a distribution arrangement with DAKO, a manufacturer and supplier of reagents used in manual IHC testing. The distribution arrangements with CMS in the United States and DAKO in Europe were inherited with the BioTek acquisition and only relate to batch processing systems. The Company plans to seek a strategic partner for the Japanese market and is in the early stages of evaluating distributors for other geographic markets. Although BioTek used third parties for sales and distribution, BioTek maintained a small field sales organization in the United States in order to support the efforts of CMS. Ventana completed the integration of BioTek's field based personnel in May 1996. Ventana's direct sales force in North America now consists of 24 direct representatives, 4 regional managers, a national managed care accounts manager, a national sales manager, 7 field based technical marketing representatives and 4 field service engineers. Ventana's patient priority systems are sold through its direct sales force. The sales force is organized around geographic territories which have been designed to provide each sales representative with an approximately equal number of sales opportunities. The Company's sales representatives typically have technical backgrounds or prior medical capital equipment sales experience. The Company's sales representatives are incentivized to both increase instrument placements and maximize recurring reagent sales. 40 43 BioTek entered into its distribution agreement with CMS in January 1993. Under the agreement, CMS has exclusive United States distribution rights for TechMate instruments and related reagents. The agreement requires CMS to make good-faith commercial efforts to purchase certain specified quantities of instruments and to maintain a sufficient inventory of reagents to meet customer requests. Under the terms of the agreement, CMS is guaranteed specified gross profit margins on instruments, subject to BioTek's prior approval of sales below prices prescribed by the agreement. Repairs, customer service and provision of spare parts are the responsibility of BioTek. BioTek is obligated to repurchase at cost all unsalable instruments and any slow-moving reagents. Unless earlier amended, replaced or terminated, the agreement with CMS expires in April 1998. United States sales through CMS are subject to several operating conditions. In particular, it has historically been necessary for BioTek to support, and the Company anticipates that it will need to continue to support, the efforts of CMS with direct field sales and support personnel. As a result, the Company generates lower gross margins on sales through CMS than it would generate were it to sell directly to end-users and incurs higher selling expenses than typically associated with third-party distribution arrangements. As a result of these factors and due to the presence of the Company's direct sales force in the United States, the Company does not intend to renew the agreement with CMS upon its expiration in April 1998. The Company has had discussions regarding possible modifications to or early termination of the relationship with CMS. However, these discussions are not currently ongoing. Ventana's sales force in Europe consists of eight sales and support personnel located in France. This sales force markets and sells Ventana's patient priority systems direct in France, Germany and the Benelux countries and markets and sells through distribution relationships in Italy, Spain and Scandinavia. This sales force is geographically organized and is compensated in a manner similar to the United States sales force. Ventana expects to significantly expand its direct sales and marketing activities in Europe in 1996 and 1997. BioTek entered into its agreement with DAKO in September 1994. DAKO is a market leader in Europe in supplying reagents for use in manual IHC tests. DAKO has exclusive rights to distribute TechMate instruments and related accessories in Europe and several other territories. The agreement also permits DAKO to supply customers with its own reagents for the instruments in return for paying BioTek a fixed dollar royalty amount over a five-year royalty term for each instrument installed at a customer site. As of March 31, 1996, there were 115 instruments included in the royalty base. Under the agreement, DAKO is subject to certain minimum purchase requirements for instruments. In connection with BioTek's agreement with DAKO, DAKO made two loans secured by a pledge of substantially all of BioTek's assets. DAKO also made prepayments on future instrument sales and reagent royalties to BioTek. These loans and prepayments were used to fund TechMate 250 instrument development and working capital requirements. The aggregate balance of the secured loans and prepayments was $1.6 million and $0.9 million, respectively, at March 31, 1996. Of the secured loans, $0.3 million bears interest at 5% per annum and the remaining $1.3 million does not bear interest. The prepayments do not bear interest. The secured loans and prepayments are recorded as advances from distributor in the Company's Consolidated Financial Statements. The amounts payable under these loans are repaid through discounts on DAKO purchases of instruments from BioTek. Upon termination of the distribution agreement or in the event of a default by BioTek under the distribution agreement (including a failure to satisfy development milestones with respect to the TechMate 250 instrument), these loans will convert to fixed term loans that will be due and payable in 12 equal quarterly installments commencing upon such event. Since the acquisition of BioTek, Ventana and DAKO have been engaged in discussions regarding various provisions of the distribution agreement. DAKO has asserted that BioTek has not fulfilled its obligations with respect to the development and commercial introduction of the TechMate 250 instrument. The Company denies this assertion and believes that it is in substantial compliance with its obligations under these development milestones. In particular, the Company believes that the recent contract manufacturing agreement with LJL will enable it to satisfy DAKO's requirements for TechMate 250 instruments. Nevertheless, the negotiations with DAKO could result in an attempt by DAKO to exercise contractual remedies available to it under the distribution agreement and the terms of the secured loans, an interruption in the distribution of the Company's batch processing instruments outside the United States or litigation between the parties with respect to the agreement, which would involve significant costs as well as diversion of 41 44 management time. Any of the foregoing could have a material adverse effect on the Company's business, financial condition and results of operations. There can be no assurance that the Company would prevail in any litigation involving the agreement. DAKO's remedies under the agreement include (i) requiring repayment of the secured loans in 12 equal quarterly installments commencing upon a default by BioTek and (ii) an irrevocable license to manufacture TechMate instruments for resale internationally and a related reduction in the fixed dollar royalty rate paid by DAKO to BioTek for each instrument included in the royalty base. There can be no assurance as to the future course or outcome of the Company's negotiations with DAKO or as to the Company's future relationship with DAKO. If DAKO were successful in obtaining a manufacturing license for TechMate instruments, the Company could experience a loss of instrument revenue which could have a material adverse effect on the Company's business, financial condition and results of operations. In addition, termination of the agreement with DAKO could adversely affect the Company's results of operations. Ventana's sales and marketing strategy for its systems is focused on increasing its penetration of the hospital and laboratory market through several instrument placement options. The options include conventional sales, financing through a third-party lease company and RAPs. RAP contracts currently being offered by the Company are generally for a one-year term, are automatically renewed unless the customer gives notice of nonrenewal and are cancellable during an initial 180-day trial period. Due to the working capital requirements associated with RAPs, the Company has historically sought to limit the amount of instruments placed through RAPs to approximately 30% of instrument placements. However, the Company anticipates that the percentage of instruments placed through RAPs will increase with the introduction of the NexES and TechMate 250 and as the Company obtains the additional working capital required to support additional RAP placements, which may in the future result in a decrease in instrument sales both in absolute dollars and as a percentage of total revenues. As of March 31, 1996, the Company had placed 72 instruments through RAPs. A key component of the Company's business strategy is to increase the sale of reagents into its installed instrument base through a high level of customer support. The Company's technical marketing representatives assist in training customers in the use of the Company's systems and seek to increase customer reagent utilization by facilitating the transfer of workload from manual procedures. Through direct customer contact, the Company's technical marketing representatives are able to promote sales of reagents and suggest new IHC test applications to customers. New customers receive initial training on the systems either in the field or at Ventana's facilities in Tucson, Arizona. The Company's technical marketing representatives then visit the customer to provide additional on-site training. Thereafter, Ventana actively supports customers with periodic product bulletins and provides 24-hour customer telephone support. Ventana actively markets its products through participation at industry trade shows, video and audio presentations by leading pathologists and direct mail. The Company provides emergency field service for instruments during an initial warranty period of 6 to 12 months. After the warranty period has expired, field service is provided under service contract or on a billed time and material basis. As of April 30, 1996 the Company had 85 instruments under service contracts out of a total of approximately 230 instruments in the United States that are outside the warranty period. Current annual service contract prices typically range from $4,250 to $6,500. MANUFACTURING The Company manufactures its patient priority instruments at its facilities in Tucson, Arizona. The Company is currently in the process of expanding its manufacturing operations in Tucson and believes that this expansion will provide the Company with sufficient manufacturing capacity to meet its anticipated requirements for patient priority instruments for approximately the next three years. Components for patient priority instruments are purchased from a variety of vendors, subject to stringent quality specifications. The components are assembled by Ventana's highly skilled manufacturing technicians into finished products. A quality assurance group performs tests at regular intervals in the manufacturing cycle to verify compliance with the Company's specifications and regulatory requirements, including FDA GMP requirements. 42 45 A number of the components used in the ES and gen II systems are fabricated on a custom basis to the Company's specifications and are currently obtained from a limited number of sources. To date, however, the Company has not experienced any material disruptions in the supply of such components. The Company believes that additional suppliers, if required, could be obtained and qualified. To date, the Company has not experienced significant difficulties with manufacturing yields and has experienced minimal manufacturing waste in the patient priority instrument manufacturing process. The Company has relationships with third-party manufacturers for the manufacture of batch processing instruments. The Company uses Kollsman for the manufacture of TechMate 500 instruments and LJL for the manufacture of TechMate 250 instruments. The Company has entered into a contract manufacturing agreement with LJL and is negotiating a contract manufacturing agreement with Kollsman. Reagents sold for use with the Company's patient priority instruments are manufactured by Ventana, which purchases basic raw materials and performs value-added manufacturing processes, such as formulation and packaging, at its facilities. Certain components and raw materials, primarily antibodies, used in the manufacturing of the Company's reagent products are currently provided by single source vendors. To date, the Company has not experienced any material disruptions in supply from these vendors and has experienced levels of manufacturing waste in the reagent manufacturing process that it believes to be below industry averages. Reagents sold for use with the Company's batch processing instruments have historically been manufactured by third parties, with only a few final steps in the manufacturing process being performed internally. The Company expects to complete the consolidation of batch processing reagent manufacturing into Ventana's Tucson facilities in September 1996. Following this consolidation, Ventana intends to convert the manufacturing process for such reagents to the process used by Ventana in which basic raw materials are used and important value-added steps are performed internally. The goals of this transition are to capture margin and value added currently being lost through payments to third-party manufacturers, increase economies of scale in both raw material purchasing and manufacturing, standardize procedures and processes, increase control over scheduling and improve manufacturing flexibility. The Company's reagent manufacturing process at its Tucson, Arizona facility is currently semi-automated. The Company anticipates that as production volumes increase it will increase the level of automation. The Company currently has sufficient reagent manufacturing capacity to meet its anticipated needs for approximately the next three years. The Company's long-term plans are to build a separate reagent manufacturing facility in the Tucson area to increase its reagent manufacturing capacity and increase the level of automation of the manufacturing process. The Company anticipates commencing construction of this facility in 1998. The Company's manufacturing operations are required to be conducted in accordance with FDA GMP requirements. GMP requires the Company to maintain documentation and process control in a prescribed manner with respect to manufacturing, testing and quality control. In addition, the Company is subject to FDA inspections to verify compliance with GMP requirements. The Company also intends to implement manufacturing policies and procedures which will enable the Company to receive ISO 9000 certification. ISO 9000 standards are global standards for manufacturing process control and quality assurance. After mid-1998, the Company will be required to obtain the CE mark for continued sale of its products in the countries comprising the European Union. The CE mark is an international symbol of quality assurance and compliance with applicable European Union medical device directives. RESEARCH AND DEVELOPMENT The Company's research and development projects are generally divided between reagent development and instrumentation development. Reagent development emphasizes existing instrumentation, and with the recent acquisition of BioTek, is divided into consolidation and integration, patient priority, IHC and ISH projects. Instrument development emphasizes the development of new instruments and enhancements to existing instruments. 43 46 Reagent Development Projects. Ventana's objective is to consolidate the reagent manufacturing process for both patient priority and batch processing systems in order to have common formulations to improve manufacturing efficiencies. The Company estimates that reagent manufacturing will be consolidated at Ventana's Tucson facilities in September 1996 and that by 1998 the Company will have fully integrated the reagent formulations and manufacturing processes for patient priority and batch processing reagents. Ventana's principal focus in the area of new reagent product development is the introduction of new prognostic indicators. Ventana closely monitors third-party development of new primary antibodies with prognostic potential. When such prognostic markers appear, Ventana will seek to incorporate the marker into its product line or will use its licensed fusion protein technology to develop similar markers. Ventana is also developing a second generation estrogen receptor ("ER") assay for use in breast cancer diagnosis. The assay incorporates an improved primary antibody clone which significantly increases the assay's sensitivity. The improved ER assay is currently undergoing beta testing and is expected to be available for sale labelled for research use only in the fourth quarter of 1996. The Company also intends to seek appropriate FDA approvals or clearances for this product. Ventana is also improving its detection chemistry sensitivity by developing a first generation amplification kit. This amplification system will be compatible with all four existing patient priority detection chemistries marketed by the Company as well as the first generation of ISH detection chemistries currently under development. Through the use of monoclonal antibodies that recognize each of the molecules used to label nucleic acid probes in ISH tests, Ventana is developing a line of ISH detection chemistries for research use. The Company's ISH detection chemistries are scheduled for beta testing during the third quarter of 1996 with availability for commercial sale for research use expected in 1997. Instrumentation Development Projects. In addition to completion of development of the NexES instrument, Ventana has two major instrument development projects underway. The first, the COSMIC, is a microscope system which is aimed at the emerging field of telepathology and information transfer. This system uses rastering of focused light and conventional optics to provide high resolution digital images in real time. The images generated by the microscope are digitized and stored or sent to remote sites. Twelve production prototypes are currently being manufactured and beta site testing is scheduled for 1997. Ventana is also developing a barcode label printing system for use with its patient priority instruments, all of which are barcode driven. To support its patient priority systems, Ventana currently maintains a stock inventory of 125 different prepackaged barcodes. The barcode printer will enable customers to print their own barcode labels from a stock of proprietary blank barcodes. This will reduce the number of stock inventory barcode labels maintained by Ventana to one and enable the customer to include pertinent patient information on each slide for tracking purposes. At April 30, 1996, Ventana's research and development group consisted of 24 persons, many of whom have graduate degrees. Ventana's research and development activities are performed primarily in-house by Ventana employees. These efforts are supplemented by consulting services and assistance from Ventana's scientific advisors. In addition to these projects, the Company inherited with the acquisition of BioTek a development program for an ISH oven designed for use with TechMate 1000 and 500 instruments. This instrument will require substantial additional development work and will also require the development of detection chemistries for use with the instrument. During the years ended December 31, 1995, 1994 and 1993, Ventana spent $2.2 million, $1.9 million and $2.1 million, respectively, on research and development. Pro forma spending for the years ended December 31, 1995 and 1994 was $4.4 million and $2.7 million, respectively. PATENTS AND PROPRIETARY RIGHTS Ventana has pursued a strategy of patenting key technology as it relates to both the automation and the chemistry of analyzing cells and tissues on microscope slides. Ventana has been issued 10 United States patents and one European patent and has filed additional United States and international patent applications. Three of Ventana's United States patent applications have been allowed. Several of Ventana's issued United 44 47 States patents relate to reagent formulations and methods, including a reagent formulation characterized by long-term stability and a method of inhibiting evaporation of reagents during processing. Other Ventana issued United States patents relate to Ventana's reagent dispenser, the use of Ventana's liquid coverslip as an evaporation inhibitor, a tissue fixative and various aspects of the capillary gap technology underlying BioTek's batch processing instruments. Pending applications relate to chemical engineering aspects of the methods used in the automated instrument for performing IHC tests on slides and inventions related to the Company's reagents and their formulations. In addition, a patent application filed by the Company covers an improved liquid coverslip for high temperature applications. The expiration dates of the Company's issued United States patents range from March 2005 to July 2013. There can be no assurance that the Company's patent applications will result in patents being issued or that any issued patents will provide protection against competitive technologies or will be held valid if challenged. Others may independently develop products or processes similar to those of the Company or design around or otherwise circumvent patents issued to the Company. Because patent applications in the United States are maintained in secrecy until patents are issued and since publication of discoveries in scientific literature tends to lag behind actual discoveries by several months, Ventana cannot be certain that it was the first creator of inventions covered by its patents or pending patent applications or that it was the first to file patent applications for such inventions. Moreover, the Company may have to participate in interference proceedings declared by the United States Patent and Trademark Office to determine the priority of inventions, which could result in substantial cost to the Company. In the event that any relevant claims of third-party patents are upheld as valid and enforceable, the Company could be prevented from practicing the subject matter claimed in such patents, or would be required to obtain licenses from the patent owners of each of such patents or to redesign its products or processes to avoid infringement. There can be no assurance that such licenses would be available or, if available, would be available on terms acceptable to the Company or that the Company would be successful in any attempt to redesign its products or processes to avoid infringement. If the Company does not obtain necessary licenses, it could be subject to litigation and encounter delays in product introductions while it attempts to design around such patents. Alternatively, the development, manufacture or sale of such products could be prevented. Litigation would result in significant cost to the Company as well as diversion of management time. The outcome of any such litigation cannot be predicted with any assurance. Adverse determinations in any such proceedings could have a material adverse effect on the Company's business, financial condition and results of operations. BioTek is a party to litigation initiated by BioGenex relating to past infringements of patent rights of BioGenex. For a discussion of these proceedings, see "Legal Proceedings." Ventana also relies upon trade secret protection for its confidential and proprietary information. There can be no assurance that others will not independently develop substantially equivalent proprietary information or techniques, gain access to Ventana's trade secrets or disclose such technology, or that Ventana can effectively protect its trade secrets. Litigation to protect Ventana's trade secrets would result in significant cost to the Company as well as diversion of management time. Adverse determinations in any such proceedings or unauthorized disclosure of Ventana trade secrets could have a material adverse effect on Ventana's business, financial condition and results of operations. Ventana's policy is to require its employees, consultants and significant scientific collaborators to execute confidentiality agreements upon the commencement of an employment or consulting relationship with Ventana. These agreements generally provide that all confidential information developed or made known to the individual during the course of the individual's relationship with Ventana is to be kept confidential and not disclosed to third parties except in specific circumstances. Agreements with employees provide that all inventions conceived by the individual in the course of rendering services to Ventana shall be the exclusive property of Ventana. There can be no assurance, however, that these agreements will not be breached or that they will provide meaningful protection or adequate remedies for unauthorized use or disclosure of Ventana's trade secrets. 45 48 COMPETITION Competition in the diagnostic industry is intense and is expected to increase. Ventana's instrument and reagent systems for IHC tests compete with products offered by various manufacturers as well as with manual diagnostic methods. In addition, flow cytometry can be used for cellular testing and may, in certain markets, be competitive with the Company's products. Several companies, including Leica (a division of Leitz Microscope GmbH), Shandon Scientific Limited (a subsidiary of Life Sciences International PLC), BioGenex and DAKO (U.S.) have instruments that perform IHC tests and that can be used with any supplier's reagents. Although these instruments are not fully automated, the ability of these instruments to be used with any suppliers' reagents may be attractive to certain customers. As of March 31, 1996, the Company had an installed base of 581 instruments which the Company estimates is more than five times the combined installed base of instruments of all of the Company's current competitors. The major suppliers of primary antibodies in the anatomical pathology market in the United States are DAKO, BioGenex and Coulter Immunology. The primary suppliers of detection chemistries in the United States are Vector Laboratories, BioGenex and DAKO. The Company's competitors may succeed in developing products that are more reliable or effective or less costly than those developed by the Company and may be more successful than the Company in manufacturing and marketing their products. Although the Company plans to continue to work to develop new and improved products, there are other companies engaged in research and development of diagnostic devices or reagents, and the introduction of such devices or alternative methods for diagnostic testing could hinder the Company's ability to compete effectively and could have a material adverse effect on the Company's business, financial condition and results of operations. Many of the companies selling or developing diagnostic devices, instruments, reagents and genetic probe tests have financial, manufacturing, marketing and distribution resources significantly greater than those of Ventana. In addition, many of these competitors have long-term supplier relationships with Ventana's existing and potential customers. The Company's patient priority instruments require the use of the Company's detection chemistries but can be used with primary antibodies supplied by third parties, and the Company's batch processing instruments can be used with both detection chemistries and primary antibodies supplied by third parties. Accordingly, the Company encounters significant competition in the sale of reagents for use on those of its instruments that can be used with reagents supplied by third parties. GOVERNMENT REGULATION The manufacturing, marketing and sale of the Company's products are subject to regulation by governmental authorities in the United States and other countries. In the United States, clinical diagnostic devices are subject to rigorous FDA regulation. The Federal Food, Drug and Cosmetic Act governs the design, testing, manufacture, safety, efficacy, labeling, storage, record keeping, approval, advertising and promotion of the Company's products. Obtaining regulatory approval for new products within this regulatory framework may take a number of years and involves the expenditure of substantial resources. In addition, there can be no assurance that this regulatory framework will not change or that additional regulation will not arise, which may affect approval of or delay an application or require additional expenditures by the Company. The FDA regulates, as medical devices, instruments, diagnostic tests and reagents that are traditionally manufactured and commercially marketed as finished test kits or equipment. Some clinical laboratories, however, choose to purchase individual reagents intended for specific analytes and develop and prepare their own finished diagnostic tests. Although neither the individual reagents nor the finished tests prepared from them by the clinical laboratories have traditionally been regulated by the FDA, the FDA has recently proposed a rule that, if adopted, would regulate the reagents sold to clinical laboratories as medical devices. The proposed rule would also restrict sales of these reagents to clinical laboratories certified under CLIA as high complexity testing laboratories. The Company intends to market some diagnostic products as finished test kits or equipment and others as individual reagents; consequently, some or all of these products will be regulated as medical devices. 46 49 The Company's clinical diagnostic systems are regulated by the FDA under a 3-tier classification system -- Class I, II and III. The degree of regulation, as well as the cost and time required to obtain regulatory approvals, generally increases from Class I to Class III. Most diagnostic devices are regulated as Class I or Class II devices, although certain diagnostic tests for particular diseases may be classified as Class III devices. Prior to entering commercial distribution, most Class I, II, or III medical devices must undergo FDA review under one of two basic review schemes depending upon the type of device or procedure. These review schemes are the 510(k) pre-market notification process and the PMA process. A 510(k) notification is generally a filing submitted to demonstrate that the device in question is "substantially equivalent" to another legally marketed device. Approval under this procedure may be granted within 90 days, but generally takes longer, and in some cases up to a year or more. Class I and II devices, as well as certain Class III devices for which the FDA has not called for a PMA, are reviewed under the 510(k) process. For all other Class III products, the manufacturer must file a PMA to show that the product is safe and effective based on extensive clinical testing and controlled trials among several diverse testing sites and population groups. These controlled trials may be conducted under an Investigational Device Exemption ("IDE") cleared by the FDA, or they may be conducted without FDA review if exempt from IDE requirements. The PMA process typically involves significantly more clinical testing than does the 510(k) procedure and could involve a significantly longer FDA review period after the date of filing. In responding to a PMA application, the FDA can either accept it for filing or reject it and require the manufacturer to include additional information in a resubmitted application. PMA applications that are accepted for filing may be reviewed by an FDA scientific advisory panel, which issues either a favorable or unfavorable recommendation regarding the device. The FDA is not bound by the panel's recommendation, but tends to give it significant weight. By law, the PMA process is to be completed within 180 days of acceptance of the PMA application for filing, although this time period can be, and typically is, extended by the FDA. A PMA application can take from one to several years to complete, and there can be no assurance that any submitted PMA application will ultimately be approved. Further, clearance or approval may place substantial restrictions on to whom and the indications for which the product may be marketed or to whom it may be marketed. Additionally, there can be no assurance that the FDA will not request additional data, or request that the Company conduct further clinical studies. The Company's instruments, with respect to automated IHC testing functions, been categorized by the FDA as automated cell staining devices and have been exempted from the 510(k) notification process. To date, ISH tests have not received FDA approval and, therefore, use of the gen II for ISH tests will be restricted to research applications. New instrument products that the Company may develop and introduce could require 510(k) notifications and clearances or PMA applications. All of the detection chemistries and most of the primary antibody products being sold by the Company are currently classified as Class II devices. Many of Ventana's detection chemistries have received 510(k) clearance from the FDA. Some of the antibodies being marketed by the Company are labeled for diagnostic use and have received 510(k) clearance from the FDA. The Company may wish to market certain antibodies with a label indicating that they can be used in the diagnosis of particular diseases, including cancer. These devices may be classified as Class III devices and may therefore require a PMA. After products have been cleared for marketing by the FDA, the Company will be subject to continuing FDA obligations. Clearances may be withdrawn or products may be recalled if compliance with regulatory standards is not maintained or if problems occur after the product reaches the market. The FDA may require surveillance programs to monitor the effect of products which have been commercialized, and has the power to prevent or limit further marketing of the product based on the results of these post-marketing programs. The FDA enforces regulations prohibiting the marketing of products for unapproved uses. Further, if the Company wanted to make changes on a product after FDA clearance or approval, including changes in indications or intended use or other significant modifications to labeling or manufacturing, additional clearances or approvals would be required. The FDA has broad regulatory and enforcement powers including the ability to levy fines and civil penalties, suspend or delay issuance of approvals, seize or recall products, withdraw clearances or approvals, restrict or enjoin the marketing of products, and impose civil and criminal penalties, any one or more of which could have a material adverse effect upon the Company. 47 50 The Company is subject to FDA GMP regulations. The Company is in the process of implementing policies and procedures which are intended to allow the Company to receive ISO 9000 certification. ISO 9000 standards are worldwide standards for manufacturing process control, documentation and quality assurance. There can be no assurance that the Company will be successful in meeting ISO 9000 certification requirements. Under GMP regulations and ISO 9000 standards, the Company is subject to ongoing FDA and international compliance inspections. Laboratories using the Company's diagnostic devices for clinical use in the United States are regulated under CLIA, which is intended to ensure the quality and reliability of medical testing. Regulations implementing CLIA establish requirements for laboratories and laboratory personnel in the areas of administration, participation and proficiency testing, patient test management, quality control, personnel, quality assurance and inspection. Under these regulations, the specific requirements that a laboratory must meet depend on the complexity of the test being performed by the laboratory. Under CLIA regulations, all laboratories performing moderately complex or highly complex tests will be required to obtain either a registration certificate or certificate of accreditation from the Health Care Financing Administration. CLIA requirements may prevent some clinical laboratories from using certain of the Company's diagnostic products. Therefore, there can be no assurance that CLIA regulations and future administrative interpretations of CLIA will not have a material adverse impact on the Company by limiting the potential market for the Company's products. The Company sells products in certain international markets and plans to enter additional international markets. International sales of medical devices are subject to foreign government regulation, the requirements of which vary substantially from country to country. These range from comprehensive device approval requirements for some or all of the Company's medical device products to requests for product data or certifications. FDA approval is required for the export of Class III devices. In addition to the foregoing, the Company is subject to numerous federal, state and local laws and regulations relating to such matters as safe working conditions, laboratory and manufacturing practices, fire hazard control, disposal of hazardous or potentially hazardous substances and other environmental matters. To date, compliance with these laws and regulations has not had a material effect on the Company's financial position, and the Company has no plans for material capital expenditures relating to such matters. However, there can be no assurance that it will not be required to incur significant costs to comply with such laws and regulations in the future, or that such laws or regulations will not in the future have a material adverse effect on the Company's business. Any violation of, and the cost of compliance with, these regulations could have a material adverse effect on the Company's business, financial condition and results of operations. Although the Company believes it will be able to comply with all applicable regulations regarding the manufacture and sale of diagnostic products, such regulations are always subject to change and depend heavily upon administrative interpretations. Delays in or failure to receive clearances or approvals of products the Company plans to introduce, or changes in the applicable regulatory climates could have a material adverse effect upon the business, financial condition or results of operations of the Company. THIRD-PARTY REIMBURSEMENT Third-party payors, such as governmental programs and private insurance plans, can indirectly affect the pricing or relative attractiveness of the Company's products by regulating the maximum amount of reimbursement they will provide to the Company's customers for diagnostic testing services. In recent years, health care costs have risen substantially, and third-party payors have come under increasing pressure to reduce such costs. In this regard, legislative proposals relating to health care reform and cost containment have been introduced at the state and federal levels. The cost-containment measures that health care payors are instituting and the impact of any health care reform could have a material adverse effect on the levels of reimbursement the Company's customers receive from third-party payors and as a result on the Company's ability to market and sell its products. Such factors could have a material adverse effect on the Company's business, financial condition and results of operations. 48 51 FACILITIES Ventana's research laboratories, instrument and reagent manufacturing facilities and administrative offices are located in approximately 30,000 square feet of leased space in Tucson, Arizona. The lease expires in March 2001, subject to renewal terms. The BioTek research laboratory and reagent manufacturing facilities are located in a 8,500 square foot facility in Santa Barbara, California. This lease expires in September 1998; however, these operations are expected to be consolidated into the Tucson facilities in September 1996. The Company believes these premises can be subleased for the remaining term of the lease. EMPLOYEES As of April 30, 1996, Ventana employed 126 persons full time. Of these employees, 57 were engaged in sales and marketing, 24 in research and development, 30 in manufacturing and 15 in general and administrative functions. None of Ventana's employees are covered by a collective bargaining agreement. Ventana considers its relations with its employees to be satisfactory. BACKLOG Ventana typically ships orders for instruments and reagents shortly after receipt, and accordingly does not maintain a significant backlog. LEGAL PROCEEDINGS In March 1995, BioGenex sued BioTek in federal court for infringement of certain patents held by BioGenex relating to an antigen retrieval method used in IHC tests. BioGenex's claims include claims of both direct and contributory infringement. BioTek has denied infringement and has asserted several defenses, including invalidity of the patent that is the subject of the litigation. In April 1995, BioTek ceased offering the products that were the subject of the alleged infringements. BioTek's total sales of these products during the period were approximately $0.6 million. A trial is currently scheduled for October 1, 1996. The parties have, from time to time, engaged in settlement negotiations. There can, however, be no assurance that a pre-trial settlement will be reached. Although there can be no assurance as to the ultimate resolution of this matter, based on currently available information, the Company does not believe that the resolution of this matter will have a material adverse effect on the Company's business, financial condition or results of operations. The Company has received notices of various claims from certain current and former employees of BioTek. To date, no litigation has been instituted by any of these individuals. However, there can be no assurance that such individuals will not institute litigation against the Company. Based on its review of these matters, the Company does not believe that their resolution will have a material adverse effect on the Company's business, financial condition or results of operations. Other than the foregoing litigation, the Company is not a party to any material pending litigation. 49 52 MANAGEMENT DIRECTORS AND EXECUTIVE OFFICERS The following table sets forth certain information regarding the directors and executive officers of the Company as of May 15, 1996:
NAME AGE POSITION -------------------------- --- --------------------------------- Jack W. Schuler(1) 55 Chairman of the Board of Directors R. James Danehy 51 President, Chief Executive Officer and Director Stephen A. Tillson, Ph.D. 55 Vice President, Scientific Affairs and Quality Assurance R. Michael Rodgers 50 Vice President, Finance, Chief Financial Officer and Secretary Michael K. Cusack 39 Vice President, Marketing Anthony L. Hartman 45 Vice President, Research and Development Brian J. McGraw 35 Director of Engineering David P. Pauluzzi 35 National Sales Manager Bernard O. C. Questier 42 Vice President, European Operations Rex J. Bates 72 Director Michael R. Danzi 36 Director Edward M. Giles(1) 60 Director Thomas M. Grogan, M.D. 50 Director John Patience(2) 48 Director C. Anthony Stellar, M.D. 66 Director James M. Strickland 53 Director James R. Weersing(2) 57 Director
- --------------- (1) Member of the Compensation Committee. (2) Member of the Audit Committee. Mr. Schuler has served as a director of Ventana since April 1991 and as Chairman of the Board of Directors since November 1995. Mr. Schuler has been Chairman of the Board of Directors of Stericycle, Inc., a specialized medical waste management company, since March 1990. Mr. Schuler is also a partner in Crabtree Partners, a Chicago based venture capital firm. Prior to joining Stericycle, Mr. Schuler held various executive positions at Abbott from December 1972 through August 1989, serving most recently as President and Chief Operating Officer. He is currently a director of Medtronic, Inc., Somatogen, Inc. and Chiron Corporation. Mr. Schuler received a B.S. in Mechanical Engineering from Tufts University and an M.B.A. from Stanford University. Mr. Danehy has served as President and Chief Executive Officer and a director of Ventana since September 1994. From June 1994 to September 1994, Mr. Danehy served as a consultant to the Company. From November 1993 to June 1994 Mr. Danehy served as an interim Chief Executive Officer and consultant for BioStar Diagnostics, where he also served as a director from January 1994 to March 1995. From 1972 to 1993, Mr. Danehy worked in a variety of capacities for Abbott. From 1977 through 1989, Mr. Danehy held marketing and general management responsibilities in Abbott's Diagnostics Division that included Product Manager for hepatitis products, Marketing Manager for Clinical Chemistry Systems, Group Marketing Manager for TDx Systems, Director of Marketing for North America and General Manager for Transfusion Diagnostics which included the AIDS test. Mr. Danehy received a B.S. in Chemistry from St. Joseph's College and an M.B.A. from Loyola University of Chicago. Dr. Tillson has served as Vice President of Scientific Affairs and Quality Assurance since August 1995. From the time of his joining Ventana in May 1992 until July 1995, Dr. Tillson served as Director of Scientific 50 53 Affairs and Quality Assurance. From January 1990 to May 1992, Dr. Tillson was as a principal of Ticon Company Consulting. He has 25 years experience in the diagnostic and pharmaceutical industry. Dr. Tillson holds a Ph.D. from Purdue University and received a B.S. from California State Polytechnic University and an M.B.A. from St. Mary's College of California. Mr. Rodgers joined Ventana in February 1994 as Chief Financial Officer and was appointed Vice President, Finance and Secretary in May 1994. From June 1992 until October 1993, Mr. Rodgers was Vice President and Chief Financial Officer with BioMedical Waste Systems, Inc., a medical waste management firm. From December 1988 to December 1991, Mr. Rodgers served as Executive Vice President of Friedkin Investments, Inc., a merchant banking firm. Mr. Rodgers received a B.S. in Business and Accounting from Menlo College and an M.B.A. from the University of Houston. Mr. Rodgers is a Certified Public Accountant. Mr. Cusack has served as Vice President of Marketing since September 1994. Mr. Cusack has also served as President Directeur General of Ventana Medical Systems, S.A., a wholly-owned subsidiary of Ventana, since September 1995. From November 1992 until joining Ventana, Mr. Cusack acted as General Manager, Europe and Mideast for CYTYC S.A.R.L., a medical diagnostics company with operations in the United States and abroad. Prior to CYTYC, Mr. Cusack held various marketing and managerial positions with Abbott's Diagnostics Division. Mr. Cusack received a B.S. from the University of Delaware and an M.B.A. from Temple University. Mr. Hartman has served as Vice President of Research and Development since April 1996. Mr. Hartman joined Ventana in August 1990 as Senior Research and Development Scientist, and he has also served as Director of Product Development and Customer Support. Prior to joining Ventana, Mr. Hartman was a Research Assistant Professor of Pathology at the University of Cincinnati College of Medicine where he supervised the departmental service laboratory for IHC and ISH. Mr. Hartman received a B.S. in General Science from the University of Portland and an M.S. in Biophysics and Genetics from the University of Colorado. Mr. McGraw joined Ventana in September 1991 and has been the Director of Engineering since December 1994. Prior to Mr. McGraw's promotion to Director of Engineering, he was a Senior Engineer. From July 1987 until August 1991, Mr. McGraw held various management and system design positions in Abbott's Diagnostics Division. Mr. McGraw received a B.S. in Mechanical Engineering from West Virginia University. Mr. Pauluzzi has served as National Sales Manager of Ventana since June 1995. He had previously served in various sales positions since joining Ventana in March 1993. From January 1985 until joining Ventana, Mr. Pauluzzi worked for Abbott's Diagnostics Division in a variety of marketing and sales and product management positions. Mr. Pauluzzi received a B.B.A. in Public Accounting from Loyola University of Chicago. Mr. Questier has served as Vice President of European Operations of Ventana since February 1996. From October 1990 until joining Ventana in October 1995, Mr. Questier held a number of management positions in E.I. DuPont de Nemours, most recently as Business Manager for New Products in Europe. Mr. Questier received a degree in Chemical Engineering from the Technical Institute in Oostende, Belgium. Mr. Bates has served as a director of Ventana since April of 1996. From August 1991 to May 1995 Mr. Bates served on the Board of Directors of Twentieth Century Industries and was a member of its compensation committee. Prior to Twentieth Century Industries, Mr. Bates served as the Vice-Chairman of the Board of Directors of the State Farm Mutual Automobile Insurance Company. Mr. Bates also served as State Farm's Chief Investment Officer. In March of 1991, Mr. Bates retired from State Farm. Prior to Mr. Bates' employment with State Farm, he was a partner in the investment firm of Stein, Roe & Farnham in Chicago. Mr. Bates received a B.S. and an M.S. from the University of Chicago. Mr. Danzi has served as a director of Ventana since April 1996. Prior to the acquisition of BioTek, Mr. Danzi served as the President and Chairman of BioTek and was associated with BioTek as a director and investor since 1993. Mr. Danzi is the founder and Managing Director of Danzi Capital Group, a securities firm. Mr. Danzi received a B.S. in Materials Science and Engineering from Cornell University, is a graduate 51 54 of the United States Naval Nuclear Power School graduate level engineering program and received an M.B.A. from Harvard University. Mr. Giles has served as director of Ventana since September 1992. Mr. Giles has served as Chairman and President of The Vertical Group, Inc., a venture capital investment firm, since January 1989. Mr. Giles was previously President of F. Eberstadt & Co., Inc., a securities firm, and Vice Chairman of Peter B. Cannell & Co., Inc., an investment management firm. He is currently a director of McWhorter Technologies, Inc. Mr. Giles received a B.S.E.E. in Chemical Engineering from Princeton University and an M.S. in Industrial Management from the Massachusetts Institute of Technology. Dr. Grogan is a founder, a director and Chairman Emeritus of Ventana. He has served as a director since the founding of the Company in June 1985 and as Chairman of the Board of Ventana from June 1985 to November 1995. He is currently a professor of pathology at the University of Arizona, College of Medicine, where he has taught since 1979. He received a B.A. in Biology from the University of Virginia and an M.D. from George Washington School of Medicine. Dr. Grogan completed a post-doctorate fellowship at Stanford University. Mr. Patience has served as a director of Ventana since July 1989. Mr. Patience was a co-founder and served as a General Partner of Marquette Venture Partners, a venture capital investment firm, from January 1988 until March 1995. Since April 1995, Mr. Patience has been a partner in Crabtree Partners, a Chicago-based venture capital firm. Mr. Patience was previously a partner in the consulting firm of McKinsey & Co., specializing in health care. He is currently a director of TRO Learning, Inc. Mr. Patience received a B.A. in Liberal Arts and an L.L.B. from the University of Sydney, Australia, and an M.B.A. from the University of Pennsylvania Wharton School of Business. Dr. Stellar has served as a director of Ventana since April 1996. Since 1964, he has been in private practice as a surgeon in Laguna Hills, California. Dr. Stellar is certified by the American Board of Surgery and the Board of Thoracic Surgery and is a Fellow of the American College of Surgeons and the College of Chest Physicians. Dr. Stellar received a B.S. and an M.D. from Stanford University. Mr. Strickland has served as a director of Ventana since December 1987. Mr. Strickland is a founder and has been the General Partner of Coronado Venture Management L.P., a venture capital investment firm, since October 1986. Mr. Strickland was previously Vice President of Burr Brown Corporation, a semiconductor manufacturer. Mr. Strickland received a B.S. and an M.S. in Electrical Engineering from the University of New Mexico and an M.S. in Industrial Administration from the Carnegie Institute of Technology. Mr. Weersing has served as a director of Ventana since October 1994. Since 1984, Mr. Weersing has been a Managing Director of MBW Venture Partners, a venture capital investment firm. Mr. Weersing has also served as President of JRW Technology, Inc., a consulting firm. Mr. Weersing served as a director of Circadian, Inc., an asthma dosage management company, from December 1993 until January 1996. Circadian filed a petition under Chapter 7 of the federal bankruptcy laws in January 1996. Mr. Weersing received an B.S.M.E. and an MBA from Stanford University. BOARD OF DIRECTORS The Company's Bylaws authorize and the Company currently has a board of 10 directors. All directors hold office until the next annual meeting of stockholders or until their successors have been elected. Officers serve at the discretion of the Board of Directors. There are no family relationships among any of the directors or executive officers of the Company. The Company does not pay cash compensation to directors for serving in that capacity, although the Company does reimburse directors for expenses incurred in attending Board of Directors meetings. The Board of Directors has, among other committees, a Compensation Committee that makes recommendations concerning salaries and incentive compensation for employees of and consultants to the Company and an Audit Committee that reviews the results and scope of the audit and other services provided by the Company's independent auditors. From and after the closing date of the acquisition of BioTek and until the repayment of the principal amount of the Exchange Notes by Ventana in exchange for notes held by holders of BioTek, Ventana is obligated to nominate at its annual meetings of stockholders two 52 55 representatives of BioTek (the "BioTek Representatives") for election to Ventana's Board of Directors. The BioTek Representatives who are currently serving on the Board of Directors pursuant to this right are Michael R. Danzi and C. Anthony Stellar, M.D. EXECUTIVE COMPENSATION The following table sets forth certain information regarding the compensation of the Company's Chief Executive Officer and each of the other four most highly compensated executive officers calculated on an annual basis (salary and bonus) for services rendered in all capacities to the Company during the year ended December 31, 1995 (collectively, the "Named Executive Officers"). SUMMARY COMPENSATION TABLE
LONG-TERM COMPENSATION ----------------------- AWARDS ----------------------- ANNUAL COMPENSATION RESTRICTED SECURITIES ALL OTHER -------------------- STOCK UNDERLYING ANNUAL NAME AND PRINCIPAL POSITION YEAR SALARY($) BONUS($) AWARDS($) OPTIONS COMPENSATION($) - ------------------------------- ------ -------- ------- ---------- ---------- --------------- R. James Danehy................ 1995 $200,000 -- -- -- -- President and Chief Executive Officer Bernard O. C. Questier......... 1995 150,000(1) 0(2) -- 36,956 $63,800(3) Vice President, European Operations David P. Pauluzzi.............. 1995 84,855 48,207(4) -- 23,098 -- National Sales Manager Michael K. Cusack.............. 1995 100,054 -- -- -- -- Vice President, Marketing R. Michael Rodgers............. 1995 97,030 -- -- 15,152 -- Vice President, Finance and Chief Financial Officer and Secretary
- --------------- (1) Mr. Questier joined the Company in October of 1995. During 1995, he was paid $12,500 per month. His salary is fixed to the French Franc to protect against currency fluctuations should the United States Dollar depreciate relative to the French Franc; however, if the United States Dollar appreciates relative to the French Franc, Mr. Questier's salary shall remain unchanged. (2) Although Mr. Questier received no bonus for 1995, he was guaranteed a one-time nonrecurring $7,500 bonus in 1996 for signing his employment contract in October of 1995 and meeting certain other conditions. (3) Consists of relocation expenses of $55,000 associated with Mr. Questier's move from Germany to France, which have been accrued but not yet fully paid, and an $8,800 annual automobile allowance. (4) Consists entirely of commissions earned through employment as the Company's Northern Regional Sales Manager prior to his promotion to National Sales Manager in June of 1995. 53 56 STOCK OPTION INFORMATION The following table contains information concerning the stock option grants made to each of the Named Officers for the year ended December 31, 1995. OPTION GRANTS IN LAST YEAR
POTENTIAL REALIZABLE INDIVIDUAL GRANTS VALUE AT ASSUMED ------------------------------------------------------ ANNUAL RATES OF NUMBER OF % OF TOTAL STOCK PRICE SECURITIES OPTIONS EXERCISE APPRECIATION FOR UNDERLYING GRANTED TO OR BASE OPTION TERM(4) OPTIONS EMPLOYEES PRICE EXPIRATION ------------------- NAME GRANTED(1) IN 1995(2) ($/SH)(3) DATE 5%($) 10%($) - -------------------------- ---------- ---------- --------- ---------- ------- ------- R. James Danehy........... -- -- -- -- -- -- Bernard O. C. Questier.... 36,956 11.39% $0.84 10/4/05 $19,496 $49,406 David P. Pauluzzi......... 23,098 7.12 0.84 4/4/05- 12,185 30,879 6/30/05 Michael K. Cusack......... -- -- -- -- -- -- R. Michael Rodgers........ 15,152 4.67 0.84 4/4/05 7,993 20,256
- --------------- (1) Options were granted under the Company's 1988 Stock Option Plan. These generally vest over four years from the date of grant. (2) Based on an aggregate of 324,467 options granted by the Company in the year ended December 31, 1995 under the Company's 1988 Stock Option Plan to all employees of and consultants to the Company, including the Named Executive Officers. (3) The exercise price per share of each option was equal to the fair market value of the Common Stock on the date of grant as determined by the Company's Board of Directors. (4) The 5% and 10% assumed annual rates of compounded stock price appreciation are mandated by rules of the Securities and Exchange Commission. There can be no assurance provided to any executive officer or any other holder of the Company's securities that the actual stock price appreciation over the 10-year option term will be at the assumed 5% and 10% levels or at any other defined level. Unless the market price of the Common Stock appreciates over the option term, no value will be realized from the option grants made to the executive officers. AGGREGATED OPTION EXERCISES IN LAST YEAR AND YEAR-END OPTION VALUES The following table sets forth, for each of the Named Executive Officers, the shares acquired and the value realized on exercises of stock options during the year ended December 31, 1995 and the year-end number and value of exercisable and unexercisable options.
NUMBER OF SECURITIES UNDERLYING VALUE OF UNEXERCISED UNEXERCISED OPTIONS IN-THE-MONEY OPTIONS SHARES AT DECEMBER 31, 1995 AT DECEMBER 31, 1995 ACQUIRED ON VALUE ---------------------------- ---------------------------- NAME EXERCISE(#) REALIZED($) EXERCISABLE UNEXERCISABLE EXERCISABLE UNEXERCISABLE - ----------------------- ----------- ------------ ----------- ------------- ----------- ------------- R. James Danehy........ -- -- 4,968 209,419 $ 3,898 $ 164,333 Bernard O.C. Questier............. -- -- -- 36,956 -- 29,000 David P. Pauluzzi...... 1,899 $1,461 661 25,157 495 19,620 Michael K. Cusack...... -- -- 8,623 20,942 6,767 16,433 R. Michael Rodgers..... 9,239 6,500 4,157 31,320 3,150 23,040
- --------------- (1) The value of "in-the-money" stock options represents the positive spread between the exercise price of stock options, which ranges from $0.60 per share to $0.95 per share, and the fair market value for the Company's Common Stock of $1.62 per share as of December 31, 1995, as determined by the Company's Board of Directors. 54 57 EMPLOYMENT AGREEMENTS The Company has an employment agreement with Bernard O.C. Questier, its Vice President of European Operations. The agreement provides for annual compensation of $150,000, which is fixed to the French Franc to protect against currency fluctuations should the United States Dollar depreciate relative to the French Franc; however, if the United States Dollar appreciates relative to the French Franc, Mr. Questier's salary shall remain unchanged. The agreement also provides for, in the event of Mr. Questier's termination, continued compensation through the quarter in which notice of termination is given plus one additional full quarter. The agreement does not provide for any specified term of employment. The Company currently has no employment contracts or agreements with any of the other Named Executive Officers or with any other person. COMPENSATION COMMITTEE INTERLOCKS AND INSIDER PARTICIPATION The Compensation Committee of the Board of Directors consists of Jack W. Schuler and Edward M. Giles. The Compensation Committee makes recommendations to the Board of Directors concerning salaries and incentive compensation for employees of and consultants to the Company, except that the Compensation Committee has full power and authority to grant stock options to the Company's executive officers under the Company's 1996 Stock Option Plan. Mr. Danehy served as a member of the Compensation Committee until April 1996. STOCK PLANS 1996 Stock Option Plan. The Company's 1996 Stock Option Plan (the "1996 Stock Plan") was adopted by the Board of Directors in April 1996. A total of 1,000,000 shares of Common Stock are reserved for issuance under the 1996 Stock Plan. As of May 15, 1996, no options to purchase shares of Common Stock have been granted pursuant to the 1996 Stock Plan. 1988 Stock Option Plan. The Company's 1988 Stock Option Plan (the "1988 Stock Plan") was adopted by the Board of Directors in March 1988 and approved by the stockholders in February 1989. A total of 1,339,663 shares of Common Stock are reserved for issuance under the 1988 Stock Plan. As of May 15, 1996, 298,453 shares of Common Stock had been issued upon exercise of stock options, options to purchase an aggregate of 840,357 shares were outstanding at a weighted average exercise price of $2.48 per share, and 200,842 shares remained available for future issuance under the 1988 Stock Plan. 1991 Employee Stock Purchase Plan. The Company's 1991 Employee Stock Purchase Plan (the "1991 Purchase Plan") was adopted by the Board of Directors in 1991 and approved by the stockholders in 1991. Shares of Preferred Stock convertible into an aggregate of 92,391 shares of Common Stock have been authorized for issuance under the 1991 Purchase Plan of which 82,408 shares have been issued. The 1991 Purchase Plan, which is intended to qualify under Section 423 of the Code, is administered by the Board of Directors of the Company or by a committee appointed by the Board of Directors. The 1991 Purchase Plan will terminate on June 30, 1996 at the conclusion of the current purchase period. 1996 Employee Stock Purchase Plan. The Company's 1996 Employee Stock Purchase Plan (the "1996 Purchase Plan") was adopted by the board of directors in April 1996. A total of 200,000 shares of Common Stock are reserved for issuance under the 1996 Purchase Plan. Under the 1996 Purchase Plan, the Company withholds a specified percentage of each salary payment to participating employees over certain offering periods. Any employee who is currently employed for at least 20 hours per week and more than five months in a calendar year by the Company or any majority owned subsidiary designated by the Board of Directors from time to time, and who does not own 5% or more of the total combined voting power or value of all classes of the capital stock of the Company or of any subsidiary of the Company, is eligible to participate in the 1996 Purchase Plan. Unless the Board of Directors determines otherwise, each offering period will run for 24 months and will be divided into four consecutive periods of approximately six months. The first offering period and first purchase period will commence on or about the date of this Prospectus. New offering periods will commence every six months. The price at which stock is purchased under the 1996 Purchase Plan is equal to 55 58 85% of the fair market value of the Common Stock on the first day of the applicable offering period or the last day of the applicable purchase period, whichever is lower. SECTION 401(K) PLAN In September 1993, the Company adopted a Retirement Savings and Investment Plan that is intended to qualify under Section 401(k) of the Code (the "401(k) Plan") covering the Company's full-time employees located in the United States. Pursuant to the 401(k) Plan, employees may elect to reduce their current compensation by up to the statutorily prescribed annual limit ($9,500 in 1996) and have the amount of such reduction contributed to the 401(k) Plan. The 401(k) Plan permits, but does not require, additional matching contributions to the 401(k) Plan by the Company on behalf of all participants in the 401(k) Plan. To date, the Company has not made any contributions to the 401(k) Plan. LIMITATIONS ON DIRECTORS' LIABILITIES AND INDEMNIFICATION The Company has adopted provisions in its Restated Certificate of Incorporation that eliminate the personal liability of its directors for monetary damages arising from breach of their fiduciary duties in certain circumstances to the fullest extent permitted by law, and authorize the Company to indemnify its directors and officers to the fullest extent permitted by law. Such limitation of liability does not apply to liabilities arising under the federal securities laws and does not affect the availability of equitable remedies such as injunctive relief or rescission. The Company's Bylaws provide that the Company will indemnify its directors and officers to the fullest extent permitted by Delaware law, including circumstances in which indemnification is otherwise discretionary under Delaware law. The Company has entered into indemnification agreements providing for the foregoing with its directors and executive officers. The indemnification agreements may require the Company, among other things, to indemnify such officers and directors against certain liabilities that may arise by reason of their status or service as officers or directors (other than liabilities arising from willful misconduct of a culpable nature) and to advance their expenses incurred as a result of any proceeding against them as to which they could be indemnified. At present, there is no pending litigation or proceeding involving a director or officer of the Company where indemnification is required or permitted, nor is the Company aware of any threatened litigation or proceeding that may result in a claim for such indemnification. 56 59 CERTAIN TRANSACTIONS Since January 1, 1993, the Company has sold shares of Series D Preferred Stock convertible into shares of Common Stock in private financings. In connection with such sales, the Company has also issued warrants to acquire shares of Series D Preferred Stock at an exercise price of $5.82 which are convertible into shares of Common Stock. The purchasers of the Series D Preferred Stock included the following 5% stockholders, directors and entities affiliated with directors.
SHARES OF SERIES D SHARES OF SERIES D PREFERRED STOCK NAME PREFERRED STOCK(1) UNDERLYING WARRANTS -------------------------------------------- ------------------ ------------------- DIRECTORS AND ENTITIES AFFILIATED WITH DIRECTORS Entities affiliated with Coronado Venture Fund (James M. Strickland)..................... 103,136 860 Edward M. Giles IRA......................... 1,211 61 MBW Venture Partners, L.P. (James R. Weersing)................................. 90,466 4,524 Jack W. Schuler............................. 12,200 611 Entities affiliated with The Vertical Group (Edward M. Giles)......................... 10,624 533 Rex J. Bates................................ 5,090 255 OTHER 5% STOCKHOLDERS State Farm Mutual Automobile Insurance Company................................... 171,890 8,780 Entities affiliated with Marquette Venture Partners.................................. 475,123 6,716
- --------------- (1) Each share of Preferred Stock will convert into one share of Common Stock upon the closing of this Offering. In April 1996, the Company sold an aggregate of 646,659 shares of Common Stock to Jack Schuler, the Company's Chairman, John Patience, a director of the Company, and venture capital funds affiliated with Marquette Venture Partners ("Marquette"), a principal stockholder of the Company, at a purchase price of $1.62 per share. Messrs. Schuler and Patience paid the purchase price for their shares 10% in cash and 90% through a full recourse promissory note secured by the underlying shares of Common Stock. Marquette paid the purchase price for their shares in cash. These stock purchases were approved by the Company's Board of Directors in principle in January 1996 and the specific terms of the stock purchases were approved by the Board of Directors on February 23, 1996. Messrs. Schuler and Patience were provided with the opportunity to purchase these shares in connection with (i) their efforts and assistance in completing the BioTek acquisition and assisting management with the integration of the companies, (ii) Mr. Schuler's decision to serve as Chairman of the Board of Directors and (iii) Mr. Schuler's and Mr. Patience's devotion of a significant portion of their work time to the Company's business. These shares are subject to a right of repurchase at cost in favor of the Company, which repurchase right will lapse as the shares become vested. The shares will become vested as follows: (i) an aggregate of 193,946 shares (including 97,010 shares purchased by Mr. Schuler, 66,753 shares purchased by Mr. Patience and 30,183 shares purchased by Marquette) will become vested upon the completion of this Offering, (ii) 172,462 shares purchased by Mr. Schuler will vest in 48 equal monthly installments commencing February 26, 1996 provided that Mr. Schuler continues to serve as Chairman of the Board of Directors, and (iii) 129,347 shares purchased by Mr. Patience and 150,904 shares purchased by Mr. Schuler will vest in 24 equal monthly installments provided that such individuals devote one-half of their work time to the Company's business on a cumulative basis over such vesting period. In August 1994 the Company hired R. James Danehy to serve as President, Chief Executive Officer and a director of the Company. In connection therewith, the Company issued Mr. Danehy a stock option (the "Option") covering 295,650 shares of Common Stock at an exercise price of $0.84 per share. In addition, the 57 60 Company provided Mr. Danehy the opportunity to purchase up to $200,000 of Series D Preferred Stock at $5.82 per share. As an incentive to purchase such shares, the Company also provided Mr. Danehy the opportunity to purchase approximately 0.37 additional shares of Common Stock at $0.84 per share for each two shares of Series D Preferred Stock purchased. Mr. Danehy acquired 34,378 shares of Series D Preferred Stock and 17,189 shares of Common Stock pursuant to this right in January 1996. In order to facilitate the transfer of shares to Mr. Danehy's individual retirement account ("IRA"), the Company in November 1995 cancelled 81,263 shares subject to the Option which had vested and allowed Mr. Danehy to purchase 81,263 shares of Common Stock at a purchase price of $0.84 per share through his self-directed IRA. In January 1996 the Company granted Mr. Danehy options to acquire 28,974 shares of Common Stock at $1.62 per share. In February 1996 the Company acquired BioTek for aggregate consideration of $18.8 million including the issuance of approximately $12.0 million in Exchange Notes in exchange for notes held by the holders of BioTek. In addition, $0.2 million in Exchange Notes were held back from the amounts payable at the closing of the acquisition and placed in escrow to indemnify Ventana from losses incurred in connection with certain matters related to the acquisition. Until the Exchange Notes have been repaid, the Company is obligated to nominate at its annual meeting of stockholders two BioTek Representatives for election to Ventana's Board of Directors. The BioTek Representatives currently serving on the Ventana Board are Michael R. Danzi and C. Anthony Stellar, M.D. In connection with the acquisition, Mr. Danzi and Dr. Stellar exchanged BioTek notes for Exchange Notes in aggregate principal amounts of $85,620 and $1,110,094, respectively. The Exchange Notes provide each holder, during a 30-day period, the opportunity to convert Exchange Notes into shares of Ventana Common Stock at a conversion price of $13.53 per share. Holders of Exchange Notes who did not make an election to convert all or any portion of such holders' Exchange Notes were deemed to have automatically converted one-half of the principal amount of such holders' Exchange Notes. No interest was deemed to accrue on the balance of Exchange Notes which were converted. Upon expiration of the conversion period, an aggregate of $3.0 million in principal amount of Exchange Notes were converted into 225,100 shares of Common Stock and an aggregate of $9.2 million of Exchange Notes remained outstanding. In connection with the acquisition in February 1996, the Company issued (the "BioTek Financing") $4.6 million of convertible subordinated debt (the "Notes") together with warrants to purchase 800,343 shares of Series D Preferred Stock at an exercise price of $5.82 per share (the "Warrants") to certain current stockholders of the Company. The proceeds from the issuance of the Notes were used to fund all of the cash portion of the consideration paid by Ventana to acquire BioTek plus related working capital requirements. In May 1996, the Company provided all holders of Preferred Stock who did not participate in the BioTek Financing the opportunity to purchase identical securities as were issued in the BioTek Financing and pursuant to the election by such holders, $0.45 million principal amount of Notes and Warrants to acquire 78,808 shares of Series D Preferred Stock were issued. The Notes were convertible into Common Stock at a conversion price of $13.53 per share for a period of 30 days from issuance. No holders elected to convert their Notes into Common Stock. The following table sets forth the aggregate principal amount of the Ventana 58 61 Notes and the number of shares of Series D Preferred Stock to be issued upon exercise of the Warrants held by executive officers, directors and 5% stockholders:
SHARES LOAN UNDERLYING PRINCIPAL WARRANTS --------- ---------- MBW Venture Partners, L.P...................................... 938,424 162,059 State Farm Mutual Automobile Insurance Company................. 630,555 108,893 Jack W. Schuler................................................ 688,601 118,917 Entities affiliated with Edward M. Giles....................... 653,944 112,933 John Patience.................................................. 559,884 96,689 Rex J. Bates................................................... 64,698 11,173 James M. Strickland............................................ 5,000 860 Thomas M. Grogan, M.D.(1) ..................................... 2,667 459
- --------------- (1) Represents shares beneficially owned by C. Ovens, Inc. 59 62 PRINCIPAL AND SELLING STOCKHOLDERS The following table sets forth information known to the Company with respect to the beneficial ownership of its Common Stock as of May 15, 1996 (assuming the exercise of all outstanding warrants and the conversion of all outstanding shares of Preferred Stock into Common Stock), and as adjusted to reflect the sale of Common Stock offered by the Company and by each of the Selling Stockholders hereby, for (i) each Selling Stockholder, (ii) each person who is known by the Company to own beneficially more than 5% of the Company's Common Stock, (iii) each of the Company's directors, (iv) each Named Executive Officer, and (v) all directors and executive officers as a group.
SHARES BENEFICIALLY SHARES BENEFICIALLY OWNED PRIOR TO NUMBER OF OWNED AFTER THE OFFERING(1)(2) SHARES OFFERING(3) -------------------- BEING ------------------- NAME NUMBER PERCENT OFFERED NUMBER PERCENT - ---------------------------------------------- ---------- ------- --------- --------- ------- EXECUTIVE OFFICERS, DIRECTORS OR 5% STOCKHOLDERS Entities affiliated with Marquette Venture Partners(4) 520 Lake Cook Rd., Suite 450 Deerfield, IL 60015........................... 1,918,650 21.9% 444,017 1,474,633 13.4% MBW Venture Partners, L.P.(5) James R. Weersing 365 South Street Morristown, NJ 07960........................ 1,442,351 16.1 -- 1,442,351 13.0 State Farm Mutual Automobile Insurance Company(6) One State Farm Plaza Bloomington, IL 61701....................... 887,173 10.0 -- 887,173 8.0 Jack W. Schuler(7) 1419 Lake Cook Road, Suite 415 Deerfield, IL 60015......................... 965,963 10.9 -- 965,963 8.7 R. James Danehy(8)............................ 209,890 2.4 -- 209,890 1.9 R. Michael Rodgers(9)......................... 22,291 * -- 22,291 * Michael K. Cusack(10)......................... 14,053 * -- 14,053 * David P. Pauluzzi(11)......................... 10,927 * -- 10,927 * Bernard O.C. Questier......................... 0 * -- 0 * Rex J. Bates(12).............................. 31,301 * -- 31,301 * Michael R. Danzi(13).......................... 9,566 * -- 9,566 * Edward M. Giles(14)........................... 291,548 3.3 -- 291,548 2.6 Thomas M. Grogan, M.D.(15).................... 169,820 1.9 -- 169,820 1.5 John Patience(16)............................. 292,789 3.3 -- 292,789 2.6 C. Anthony Stellar, M.D.(17).................. 19,959 * -- 19,959 * James M. Strickland(7)(18).................... 402,547 4.6 -- 402,547 3.7 James R. Weersing(5)(19)...................... 1,448,560 16.5 -- 1,448,560 13.2 All directors and executive officers as a group (17 persons)........................ 3,940,247 41.2 -- 3,932,579 33.5
60 63
SHARES BENEFICIALLY SHARES BENEFICIALLY OWNED PRIOR TO NUMBER OF OWNED AFTER THE OFFERING(1)(2) SHARES OFFERING(3) -------------------- BEING ------------------- NAME NUMBER PERCENT OFFERED NUMBER PERCENT - ---------------------------------------------- ---------- ------- --------- --------- ------- OTHER SELLING STOCKHOLDERS The CIT Group/Venture Capital, Inc.(20)....... 1,186,047 13.4% 101,945 1,084,102 9.8% Interwest Partners IV, L.P. .................. 1,003,616 11.4 86,265 917,351 8.4 Victoria Bannister(21)........................ 286,863 3.3 10,744 276,119 2.5 W. Ross Humphreys(22)......................... 148,218 1.7 73,558 74,660 * J. David Lowell(23)........................... 64,191 * 28,428 35,763 * David Nunnery................................. 46,993 * 931 46,062 * Jan Karel Smeets.............................. 31,271 * 15,635 15,636 * Douglas F. Sweet.............................. 30,465 * 716 29,749 * Richard B. Peterson(24)....................... 25,955 * 5,157 20,798 * Thomas B. Healey.............................. 20,882 * 10,441 10,441 * Dorothy L. O'Neal Revocable Trust(25)......... 19,903 * 8,814 11,089 * Wm. Kent Wonders(26).......................... 12,839 * 1,895 10,944 * Entities affiliated with the Myron S. and Joan D. Eichen Family Trust(27).................. 10,175 * 2,043 8,132 * Charles J. Casebeer(28)....................... 9,765 * 260 9,505 * Jessica Youle(29)............................. 9,630 * 4,264 5,366 * Mary Cawley(30)............................... 6,653 * 3,326 3,327 * Lawrance A. Brown, Jr.(31).................... 4,958 * 613 4,345 * Philip E. McCarthy(32)........................ 2,941 * 96 2,845 * Entities affiliated with the Thomas H. and Rosemary S. Tisch Trust..................... 2,349 * 546 1,803 * Ned M. Weinshenker Money Purchase Pension Plan................................ 905 * 210 695 * Wayne L. Clevenger Pension Plan............... 411 * 96 315 *
- --------------- * Less than 1%. (1) Except as indicated in the footnotes to this table and pursuant to applicable community property laws, the persons named in the table have sole voting and investment power with respect to all shares of Common Stock. (2) Applicable percentage of ownership is based on 8,774,883 shares of Common Stock outstanding as of May 15, 1996 together with shares issuable pursuant to applicable options and warrants of such stockholder which may be exercised within 60 days after May 15, 1996. Shares of Common Stock subject to options and warrants currently exercisable or exercisable within 60 days after May 15, 1996 are deemed outstanding for computing the percentage ownership of the person holding such options and warrants, but are not deemed outstanding for computing the percentage of any other person. Assumes the issuance of 64,244 shares of Common Stock upon the assumed exercise of outstanding warrants which would otherwise expire upon the closing of this Offering. (3) Assumes no exercise of the Underwriters' Over-Allotment Option. See "Underwriting." Applicable percentage ownership is based upon 10,974,883 shares of Common Stock outstanding as of May 15, 1996 together with shares issuable pursuant to applicable options and warrants for each stockholder currently exercisable or exercisable within 60 days after May 15, 1996. 61 64 In the event that the Over-Allotment Option is exercised, entities affiliated with Marquette Venture Partners, The CIT Group/Venture Capital, Inc., Interwest Partners IV, L.P., Victoria Bannister, David Nunnery, Douglas F. Sweet, Richard B. Peterson, entities affiliated with Myron S. Eichen and Joan D. Eichen Family Trust, Charles J. Casebeer, Lawrance A. Brown, Jr., Philip E. McCarthy, entities affiliated with the Thomas H. and Rosemary S. Tisch Trust, Ned M. Weinshenker Money Purchase Plan and Wayne L. Clevenger Pension Plan will sell to the Underwriters a percentage of the shares subject to the Over-Allotment Option approximately equal to the percentage of the Shares being offered by such Selling Stockholder (and set forth in the table above) bears to the total number of Shares being offered by all such Selling Stockholders (and set forth in the table above). (4) Includes 1,464,153 shares beneficially owned by Marquette Venture Partners, L.P.; 441,871 shares beneficially owned by Marquette Venture Partners II, L.P.; and 12,626 shares beneficially owned by MVP II Affiliate Fund, L.P. (5) Includes 1,280,292 shares beneficially owned by MBW Venture Partners, L.P. (of which 162,059 shares are issuable upon the exercise of warrants held by MBW Venture Partners, L.P.). Mr. Weersing, a director of the Company, is Managing Director of MBW Venture Partners Limited. Mr. Weersing disclaims beneficial ownership of the shares beneficially owned by MBW Venture Partners, L.P. except to the extent of his proportional partnership interest therein. (6) Includes 108,893 shares issuable upon the exercise of warrants held by State Farm Mutual Automobile Insurance Company. (7) Includes 118,917 shares issuable upon the exercise of warrants held by Mr. Schuler; 73,512 shares beneficially owned by Mr. Schuler, as custodian for Tanya Eva Schuler; 73,513 shares beneficially owned by Mr. Schuler, as custodian for Tess Heidi Schuler; and 73,512 shares beneficially owned by Mr. Schuler, as custodian for Tino Hans Schuler. (8) Includes 77,059 shares issuable upon the exercise of options exercisable within 60 days of May 15, 1996 held by Mr. Danehy. (9) Includes 13,050 shares issuable upon the exercise of options exercisable within 60 days of May 15, 1996 held by Mr. Rodgers. (10) Includes 12,935 shares issuable upon the exercise of options exercisable within 60 days of May 15, 1996 held by Mr. Cusack. (11) Includes 8,056 shares issuable upon the exercise of options exercisable within 60 days of May 15, 1996 held by Mr. Pauluzzi. (12) Includes 11,173 shares issuable upon the exercise of warrants held by Mr. Bates. (13) Includes 1,087 shares beneficially owned by Barbara A. Danzi. (14) Includes 122,886 shares beneficially owned by Vertical Fund, L.P. (of which 85,945 shares are issuable upon the exercise of warrants held by Vertical Fund, L.P.); 36,741 shares beneficially owned by Vertical Medical Partners, L.P.; and 108,292 shares beneficially owned by Vertical Partners, L.P. (of which 21,831 shares are issuable upon the exercise of warrants held by Vertical Partners, L.P.). Also includes 23,429 shares beneficially owned by Edward M. Giles IRA (of which 5,157 shares are issuable upon the exercise of warrants held by Edward M. Giles IRA). Mr. Giles, a director of the Company, is Chairman and President of The Vertical Group, Inc. Mr. Giles disclaims beneficial ownership of the shares beneficially owned by such entities affiliated with The Vertical Group, Inc. except to the extent of his proportionate partnership interest therein. (15) Includes 3,696 shares beneficially owned by Andrew Grogan; 7,710 shares beneficially owned by C. Ovens, Inc. (of which 459 shares are issuable upon the exercise of warrants held by C. Ovens, Inc.); and 38,306 shares issuable upon exercise of options exercisable within 60 days of May 15, 1996 held by Dr. Grogan. (16) Includes 96,689 shares issuable upon the exercise of warrants held by Mr. Patience. (17) Includes 740 shares beneficially owned by Diane Stellar, and 740 shares beneficially owned by Andrew Stellar. 62 65 (18) Includes 860 shares issuable upon the exercise of warrants held by Mr. Strickland. Also includes 120,670 shares beneficially owned by Coronado Venture Fund; 163,059 shares beneficially owned by Coronado Venture Fund II, L.P.; 103,996 shares beneficially owned by Coronado Venture Fund III, L.P.; and 13,962 shares beneficially owned by Coronado Venture Co-Investor Limited Partnership. Mr. Strickland, a director of the Company, is a general partner of Coronado Venture Management. Mr. Strickland disclaims beneficial ownership of the shares beneficially owned by such entities except to the extent of his proportionate partnership interest therein. (19) Includes 6,209 shares beneficially owned by James R. Weersing and Mary H. Weersing, Trustees of the Weersing Family Trust U/D/T dated April 24, 1991. (20) Includes 77,351 shares issuable upon exercise of warrants held by the CIT Group/Venture Capital, Inc. (21) Includes 15,303 shares issuable upon the exercise of warrants held by Ms. Bannister. (22) Includes 1,101 shares issuable upon the exercise of warrants held by Mr. Humphreys. (23) Includes 7,334 shares issuable upon the exercise of warrants held by Mr. Lowell. (24) Includes 6,668 shares issuable upon the exercise of warrants held by Mr. Peterson. (25) Includes 2,274 shares issuable upon the exercise of warrants held by the Dorothy L. O'Neal Revocable Trust. (26) Includes 1,467 shares issuable upon the exercise of warrants held by Mr. Wonders. (27) Includes 1,134 shares issuable upon the exercise of warrants held by the Myron S. and Joan D. Eichen Family Trust. (28) Includes 1,116 shares issuable upon the exercise of warrants held by Mr. Casebeer. (29) Includes 1,101 shares issuable upon the exercise of warrants held by Ms. Youle. (30) Includes 370 shares beneficially owned by Ms. Cawley as custodian for Andrew C. Cawley, and 370 shares beneficially owned by Ms. Cawley as custodian for Graham D. Cawley. (31) Includes 1,851 shares issuable upon the exercise of warrants held by Mr. Brown. (32) Includes 2,119 shares issuable upon the exercise of warrants held by Mr. McCarthy, and 822 shares owned by the Philip E. McCarthy Pension Plan. 63 66 DESCRIPTION OF CAPITAL STOCK The authorized capital stock of the Company will consist of 50,000,000 shares of Common Stock and 5,000,000 shares of preferred stock after giving effect to the restatement of the Company's Certificate of Incorporation upon the closing of this Offering. Prior to this Offering, there has been no public market for the Company's Common Stock. The following summary of certain provisions of the Common Stock and preferred stock does not purport to be complete and is subject to, and qualified in its entirety by, the provisions of the Company's Restated Certificate of Incorporation which is included as an exhibit to the Registration Statement of which this Prospectus is a part and by the provisions of applicable law. COMMON STOCK As of May 15, 1996, there were 10,974,883 shares of Common Stock outstanding which were held of record by 359 stockholders, as adjusted to reflect the conversion of all outstanding shares of Preferred Stock upon the closing of this Offering and the issuance of 64,244 shares of Common Stock upon the exercise of outstanding warrants on the closing of this Offering. The holders of Common Stock are entitled to one vote per share on all matters to be voted upon by the stockholders. Subject to preferences that may be applicable to any outstanding preferred stock, the holders of Common Stock are entitled to receive ratably such dividends, if any, as may be declared from time to time by the board of directors out of funds legally available for that purpose. See "Dividend Policy." In the event of a liquidation, dissolution or winding up of the Company, the holders of Common Stock are entitled to share ratably in all assets remaining after the payment of liabilities, subject to prior distribution rights of preferred stock, if any, then outstanding. The Common Stock has no preemptive or conversion rights or other subscription rights. There are no redemption or sinking fund provisions applicable to the Common Stock. All outstanding shares of Common Stock are fully paid and nonassessable, and the Shares of Common Stock to be issued upon the closing of this Offering will be fully paid and non-assessable. Provisions in the Company's Certificate of Incorporation and Bylaws (i) prohibit the stockholders from acting by written consent without a meeting or calling a special meeting of stockholders and (ii) require advance notice of business proposed to be brought before an annual or special meeting of stockholders. The amendment or modification of these provisions will require the affirmative vote of the holders of 66 2/3% of the outstanding shares of Common Stock. PREFERRED STOCK Effective upon the closing of this Offering, the Company will be authorized to issue 5,000,000 shares of undesignated preferred stock, none of which will be outstanding upon the closing of this Offering. The Board of Directors will have the authority, without further action by the stockholders, to issue the undesignated preferred stock in one or more series, to fix the rights, preferences, privileges and restrictions granted to or imposed upon any wholly unissued shares of undesignated preferred stock and to fix the number of shares constituting any series and the designation of such series. The issuance of preferred stock may have the effect of delaying, deferring or preventing a change in control of the Company without further action by the stockholders, may discourage bids for the Company's Common Stock at a premium over the market price of the Common Stock and may adversely affect the market price of and the voting and other rights of the holders of Common Stock. At present, the Company has no plans to issue any of the preferred stock. WARRANTS After the completion of this Offering, the Company will have outstanding warrants to purchase 879,183 shares of Common Stock at an exercise price of $5.82 per share. These warrants are currently exercisable, will terminate in February 2001 and may be exercised on a net basis. CERTAIN PROVISIONS OF DELAWARE LAW Ventana is a Delaware corporation and subject to Section 203 of the Delaware General Corporation Law, an anti-takeover law. In general, Section 203 prohibits a publicly held Delaware corporation from engaging in a "business combination" with an "interested stockholder" for a period of three years following the date the 64 67 person became an interested stockholder, unless (with certain exceptions) the "business combination" or the transaction in which the person became an interested stockholder is approved in a prescribed manner. Generally, a "business combination" includes a merger, asset or stock sale, or other transaction resulting in a financial benefit to the stockholder. Generally, an "interested stockholder" is a person who, together with affiliates and associates, owns (or within three years prior, did own) 15% or more of a corporation's voting stock. The existence of this provision would be expected to have an anti-takeover effect with respect to transactions not approved in advance by the Board of Directors, including discouraging attempts that might result in a premium over the market price for the shares of Common Stock held by stockholders. TRANSFER AGENT AND REGISTRAR The transfer agent and registrar for the Common Stock is Norwest Bank Minnesota, N.A. Its telephone number is (800) 468-9716. SHARES ELIGIBLE FOR FUTURE SALE Prior to this offering, there has been no market for the Common Stock of the Company. Future sales of substantial amounts of Common Stock in the public market could adversely affect market prices prevailing from time to time. Sales of substantial amounts of Common Stock of the Company in the public market after the restrictions lapse could adversely affect the prevailing market price and the ability of the Company to raise equity capital in the future. Upon the completion of this Offering, the Company will have 10,974,883 shares of Common Stock outstanding, assuming no exercise of options after May 15, 1996 and no exercise of outstanding warrants other than warrants to purchase 64,244 shares of Common Stock that will terminate if not exercised upon the completion of this Offering. Of these 10,974,883 shares, the 3,000,000 shares sold in this Offering will be freely tradable without restriction under the Securities Act, unless held by "affiliates" of the Company, as that term is defined in Rule 144 under the Securities Act. The remaining 7,974,883 shares of Common Stock held by existing stockholders were issued and sold by the Company in reliance on exemptions from the registration requirements of the Securities Act. These shares may be sold in the public market only if registered, or pursuant to an exemption from registration such as Rule 144, 144(k) or 701 under the Securities Act. The Company's directors, executive officers, certain stockholders and all option holders, who in the aggregate hold 7,551,250 shares of Common Stock, have entered into lock-up agreements under which they have agreed not to offer, sell, contract to sell, grant any option to purchase or otherwise dispose of, or agree to dispose of, directly or indirectly, any shares of Common Stock, options or warrants to acquire shares of Common Stock or securities exchangeable for or convertible into Common Stock owned by them for a period of 180 days after the date of this Prospectus, without the prior written consent of Bear, Stearns & Co. Inc. The Company has entered into a similar agreement, except that the Company may grant options and issue stock under its current stock option and stock purchase plans and pursuant to other currently outstanding options. Approximately 39,703 shares of Common Stock will be available for immediate public resale on the date of this Offering. An additional 8,778 shares of Common Stock will be saleable between 90 and 180 days after this Offering. Upon expiration of the lock-up agreements, approximately 7,900,451 shares of Common Stock (including approximately 349,201 shares subject to outstanding vested options) will become eligible for immediate public resale, subject in some cases to vesting provisions and volume limitations pursuant to Rule 144. The remaining approximately 310,908 shares held by existing stockholders will become eligible for public resale at various times over a period of less than two years following the completion of this Offering, subject in some cases to vesting provisions and volume limitations. 7,277,777 of the shares outstanding immediately following the completion of this Offering will be entitled to registration rights with respect to such shares upon the release of lock-up agreements. The number of shares sold in the public market could increase if such rights are exercised. As of May 15, 1996, 840,357 shares were subject to outstanding options. All of these shares are subject to the lock-up agreements described above. As soon as practicable after the date of this Prospectus, the Company intends to file a Registration Statement on Form S-8 covering shares issuable under the Company's 65 68 1988 Stock Plan (including shares subject to then outstanding options under such plans), the Company's 1996 Stock Plan and 1996 Employee Stock Purchase Plan, thus permitting the resale of such shares in the public market without restriction under the Securities Act after expiration of the applicable lock-up agreements. In general, under Rule 144 as currently in effect, a person (or persons whose shares are aggregated) who has beneficially owned shares for at least two years (including the holding period of any prior owner, except an affiliate) is entitled to sell in "broker's transactions" or to market makers, within any three-month period commencing 90 days after the date of this Prospectus, a number of shares that does not exceed the greater of (i) one percent of the number of shares of Common Stock then outstanding (approximately 110,000 shares immediately after this Offering) or (ii) the average weekly trading volume of the Common Stock during the four calendar weeks preceding the required filing of a Form 144 with respect to such sale. Sales under Rule 144 are generally subject to certain manner of sale provisions and notice requirements and to the availability of current public information about the Company. Under Rule 144(k), a person who is not deemed to have been an affiliate of the Company at any time during the 90 days preceding a sale, and who has beneficially owned the shares proposed to be sold for at least three years, is entitled to sell such shares without having to comply with the manner of sale, public information, volume limitation or notice provisions of Rule 144. Under Rule 701 under the Securities Act, persons who purchase shares upon exercise of options granted prior to the effective date of this Offering are entitled to sell such shares 90 days after the effective date of this Offering in reliance on Rule 144, without having to comply with the holding period requirements of Rule 144 and, in the case of non-affiliates, without having to comply with the public information, volume limitation or notice provisions of Rule 144. The Securities and Exchange Commission has recently proposed reducing the initial Rule 144 holding period to one year and the Rule 144(k) holding period to two years. There can be no assurance as to when or whether such rule changes will be enacted. If enacted, such modifications will have a material effect on the times when shares of the Company's Common Stock become eligible for resale. REGISTRATION RIGHTS OF CERTAIN HOLDERS The holders of 7,277,777 shares of Common Stock (including shares issuable upon exercise of warrants) (the "Registrable Securities") or their transferees are entitled to certain rights with respect to the registration of such shares under the Securities Act of 1933, as amended (the "Securities Act"). These rights are provided under the terms of an agreement between the Company and the holders of Registrable Securities. Subject to certain limitations in the agreement, if the holders of at least 25% of the Registrable Securities request, the Company must on two occasions after six months from the effective date of this Offering, use its best efforts to register the Registrable Securities for public resale. If the Company registers any of its Common Stock either for its own account or for the account of other security holders, the holders of Registrable Securities are entitled to include their shares of Common Stock in the registration, subject to the ability of the underwriters to limit the number of shares included in the Offering. The holders of Registrable Securities may also require the Company (but not more than once during any 12-month period) to register all or a portion of their Registrable Securities on Form S-3 when use of such form becomes available to the Company, provided, among other limitations, that the proposed aggregate selling price is at least $1.0 million. All registration expenses must be borne by the Company and all selling expenses relating to Registrable Securities must be borne by the holders of the securities being registered. 66 69 UNDERWRITING The underwriters named below (the "Underwriters"), for whom Bear, Stearns & Co. Inc. and Dillon, Read & Co. Inc. are acting as representatives (the "Representatives"), have severally agreed, subject to the terms and conditions set forth in the Underwriting Agreement, to purchase from the Company and the Selling Stockholders, the number of Shares of Common Stock set forth opposite their names below:
NUMBER UNDERWRITER OF SHARES ------------------------------------------------------------------ --------- Bear, Stearns & Co. Inc........................................... Dillon, Read & Co. Inc............................................ --------- Total................................................... 3,000,000 ========
Subject to the terms and conditions of the Underwriting Agreement, the Underwriters have agreed to purchase all of the Shares of Common Stock being sold pursuant to the Underwriting Agreement if any are purchased (excluding Shares covered by the Over-Allotment Option). The Representatives have advised the Company that the Underwriters propose to offer the Common Stock to the public initially at the public offering price set forth on the cover page of this Prospectus and to selected dealers (who may include Underwriters) at such price less a concession of not more than $ per share. Additionally, the Underwriters may allow, and such dealers may reallow, a concession of not more than $ per share to certain other dealers. After the initial public offering, the public offering price and other selling terms may be changed by the Underwriters. Certain of the Selling Stockholders have granted to the Underwriters an option to purchase up to 450,000 additional Shares of Common Stock at the initial public offering price, less the underwriting discount, set forth on the cover page of this Prospectus, solely to cover over-allotments, if any. This option may be exercised in whole or in part at any time within 30 days from the date of this Prospectus. To the extent that the Underwriters exercise this option, each of the Underwriters will have a firm commitment to purchase approximately the same percentage thereof which the number of Shares of Common Stock to be purchased by it shown in the above table bears to the total number of Shares of Common Stock offered hereby. The Offering of the Shares is made for delivery, when, as and if accepted by the Underwriters and subject to prior sale and to withdrawal, cancellation or modification of the Offering without notice. The Underwriters reserve the right to reject an order for the purchase of Shares in whole or in part. The Company and the Selling Stockholders have agreed to indemnify the Underwriters against certain liabilities, including liabilities under the Securities Act and to contribute to payments the Underwriters may be required to make in respect thereof. The officers, directors and certain stockholders of the Company, who in the aggregate own 7,551,250 shares of Common Stock, have agreed that they will not, without the prior written consent of Bear, Stearns & Co. Inc., offer, sell, or otherwise dispose of any shares of Common Stock, options or warrants to acquire shares of Common Stock or securities exchangeable for or convertible into shares of Common Stock owned by them during the 180 day period following the date of this Prospectus. The Company has agreed that it will not, without the prior written consent of Bear, Stearns & Co. Inc., offer, sell or otherwise dispose of any shares of Common Stock, options or warrants to acquire shares of Common Stock or securities exchangeable for or convertible into shares of Common Stock during the 180 days following the date of this Prospectus, except that the Company may issue shares of Common Stock and options to purchase Common Stock under its 1996 Stock Plan and its 1996 Employee Stock Purchase Plan. Prior to the Offering, there has been no public market for the Common Stock. The initial public offering price for the Common Stock will be determined by negotiation among the Company and the Representatives. Among the factors to be considered in determining the initial public offering price are prevailing market and economic conditions, revenues and earnings of the Company, market valuations of other companies engaged in the health care industry, estimates of the business potential and prospects of the Company, the present state 67 70 of the Company's operations, the Company's management and other factors deemed relevant. The estimated initial public offering price range set forth on the cover of this preliminary prospectus is subject to change as a result of market conditions and other factors. The negotiated initial public offering price may bear no relationship to the price at which Common Stock trades after the Offering. The Underwriters do not intend to confirm sales to accounts over which they exercise discretionary authority. In February 1996, Bear, Stearns & Co. Inc. rendered a fairness opinion to the Company in connection with the acquisition of BioTek for which Bear, Stearns & Co. Inc. received a fee of $200,000, consisting of $50,000 in cash and 69,760 shares of Series D Preferred Stock which will convert into 25,784 shares of Common Stock upon the completion of this offering. Bear, Stearns & Co. Inc. is not selling any of its shares of Common Stock in the Offering. In addition, two officers of Bear, Stearns & Co. Inc. and one officer of Dillon, Read & Co., Inc. own an aggregate of 36,356 shares of Common Stock. LEGAL MATTERS The validity of the Common Stock offered hereby will be passed upon for the Company by Wilson Sonsini Goodrich & Rosati, Professional Corporation, Palo Alto, California. As of the date of this Prospectus, certain members of Wilson Sonsini Goodrich & Rosati, Professional Corporation and investment partnerships of which such persons are partners beneficially own 6,159 shares of the Company's Common Stock. Christopher D. Mitchell, Assistant Secretary of the Company, is a member of Wilson Sonsini Goodrich & Rosati, Professional Corporation. Certain legal matters in connection with this Offering will be passed upon for the Underwriters by Simpson Thacher & Bartlett (a partnership which includes professional corporations), New York, New York. EXPERTS The consolidated financial statements of Ventana Medical Systems, Inc. at December 31, 1994 and 1995 and for each of the three years in the period ended December 31, 1995 and the financial statements of BioTek Solutions, Inc. at June 30, 1995 and December 31, 1995 and for the year ended June 30, 1995 and the six months ended December 31, 1995, appearing in this Prospectus and Registration Statement have been audited by Ernst & Young LLP, independent auditors, as set forth in their respective reports thereon appearing elsewhere herein and in the Registration Statement, and are included in reliance upon such reports given upon the authority of such firm as experts in accounting and auditing. The financial statements of BioTek Solutions, Inc. as of June 30, 1993 and 1994 and for the two years in the period ended June 30, 1994 included in this Prospectus and Registration Statement have been audited by Arthur Andersen LLP, independent public accountants, as indicated in their reports with respect thereto, and are included herein in reliance upon the authority of such firm as experts in accounting and auditing. ADDITIONAL INFORMATION The Company has filed with the Securities and Exchange Commission (the "Commission"), Washington, D.C. 20549, a Registration Statement on Form S-1 under the Securities Act with respect to the Shares of Common Stock offered hereby. This Prospectus does not contain all the information set forth in the Registration Statement and the exhibits and schedules thereto. For further information with respect to the Company and such Common Stock, reference is made to the Registration Statement and to the exhibits and schedules filed therewith. Statements contained in this Prospectus as to the contents of any contract or document to which reference is made 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. A copy of the Registration Statement may be inspected without charge at the Commission's principal offices, and copies of all or any part of the Registration Statement may be obtained from such office upon the payment of the fees prescribed by the Commission. The Company intends to furnish its stockholders with annual reports containing consolidated financial statements audited by its independent auditors and with quarterly reports containing unaudited financial information for each of the first three quarters of each fiscal year. 68 71 INDEX TO FINANCIAL STATEMENTS
PAGE ---- VENTANA MEDICAL SYSTEMS, INC. Unaudited Pro Forma Condensed Consolidated Financial Statements Introduction to Unaudited Pro Forma Condensed Consolidated Financial Statements..... F-2 Unaudited Pro Forma Condensed Consolidated Balance Sheet as of March 31, 1996....... F-3 Unaudited Pro Forma Condensed Consolidated Statements of Operations for the Year Ended December 31, 1994.......................................................... F-4 Unaudited Pro Forma Condensed Consolidated Statements of Operations for the Year Ended December 31, 1995.......................................................... F-5 Unaudited Pro Forma Condensed Consolidated Statements of Operations for the Three Months Ended March 31, 1995...................................................... F-6 Unaudited Pro Forma Condensed Consolidated Statements of Operations for the Three Months Ended March 31, 1996...................................................... F-7 Notes to Unaudited Pro Forma Condensed Consolidated Financial Statements............ F-8 VENTANA MEDICAL SYSTEMS, INC. Report of Ernst & Young LLP, Independent Auditors..................................... F-11 Audited Consolidated Financial Statements Consolidated Balance Sheets as of December 31, 1994 and 1995 and March 31, 1996 (unaudited)...................................................................... F-12 Consolidated Statements of Operations for the years ended December 31, 1993, 1994 and 1995 and three months ended March 31, 1995 and 1996 (unaudited).............. F-13 Consolidated Statements of Convertible Redeemable Preferred Stock and Stockholders' Equity (Deficit) for the years ended December 31, 1993, 1994 and 1995 and three months ended March 31, 1996 (unaudited).......................................... F-14 Consolidated Statements of Cash Flows for the years ended December 31, 1993, 1994 and 1995 and three months ended March 31, 1995 and 1996 (unaudited).............. F-15 Notes to Consolidated Financial Statements.......................................... F-16 BIOTEK SOLUTIONS, INC. Report of Ernst & Young LLP, Independent Auditors..................................... F-26 Audited Financial Statements Balance Sheets as of June 30, 1995 and December 31, 1995............................ F-27 Statements of Operations for the year ended June 30, 1995 and six months ended December 31, 1995................................................................ F-28 Statements of Changes in Stockholders' Deficit for the year ended June 30, 1995 and six months ended December 31, 1995............................................... F-29 Statements of Cash Flows for the year ended June 30, 1995 and six months December 31, 1995......................................................................... F-30 Notes to Financial Statements....................................................... F-31 BIOTEK SOLUTIONS, INC. Report of Arthur Andersen LLP, Independent Public Accountants......................... F-37 Audited Financial Statements Balance Sheets as of June 30, 1993 and 1994......................................... F-38 Statements of Operations for the years ended June 30, 1993 and 1994................. F-39 Statements of Changes in Shareholders' Deficit for the years ended June 30, 1993 and 1994............................................................................. F-40 Statements of Cash Flows for the years ended June 30, 1993 and 1994................. F-41 Notes to Financial Statements....................................................... F-42
F-1 72 VENTANA MEDICAL SYSTEMS, INC. INTRODUCTION TO UNAUDITED PRO FORMA CONDENSED CONSOLIDATED FINANCIAL STATEMENTS The accompanying unaudited pro forma condensed consolidated balance sheet as of March 31, 1996 includes the February 26, 1996 acquisition of BioTek Solutions, Inc. (BioTek). The accompanying unaudited pro forma condensed consolidated statements of operations for the years ended December 31, 1994 and 1995 and for the three months ended March 31, 1995 and 1996 have been prepared as if the acquisition of BioTek had been consummated as of January 1, 1994. The pro forma balance sheet amounts are further adjusted to reflect the sale of the Shares of Common Stock offered hereby and the utilization of the net proceeds of this Offering as described under "Use of Proceeds." The pro forma information is based on the historical financial statements of Ventana and BioTek giving effect to the transaction under the purchase method of accounting and the assumptions and adjustments described in the accompanying Notes to Unaudited Pro Forma Condensed Consolidated Financial Statements. The pro forma information is not indicative of actual results that would have been achieved had the acquisition actually been completed as of the dates indicated. The pro forma condensed consolidated financial statements should be read in conjunction with "Management's Discussion and Analysis of Financial Conditions and Results of Operations" and the respective historical financial statements of Ventana Medical Systems, Inc. and BioTek Solutions, Inc. and the related notes thereto included elsewhere in this Prospectus. F-2 73 VENTANA MEDICAL SYSTEMS, INC. UNAUDITED PRO FORMA CONDENSED CONSOLIDATED BALANCE SHEET AS OF MARCH 31,1996 (IN THOUSANDS) ASSETS
PRO FORMA PRO FORMA HISTORICAL ADJUSTMENTS AS ADJUSTED ---------- ----------- ----------- Current assets: Cash and cash equivalents............................ $ 3,436 $ 14,977(a) $ 18,413 Accounts receivable.................................. 2,834 2,834 Inventories.......................................... 2,472 2,472 Other................................................ 695 695 -------- -------- Total current assets................................... 9,437 24,414 Property, plant and equipment, net..................... 2,923 2,923 Intangibles, net....................................... 12,392 12,392 -------- ------- -------- Total assets................................. $ 24,752 $ 14,977 $ 39,729 ======== ======= ======== LIABILITIES, CONVERTIBLE REDEEMABLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT) Current liabilities: Accounts payable..................................... $ 1,216 $ 1,216 Other current liabilities............................ 7,026 7,026 -------- -------- Total current liabilities.............................. 8,242 8,242 -------- -------- Long term debt......................................... 15,035 $ (15,035)(a) -- Convertible redeemable preferred stock................. 36,135 (36,135)(b) -- Stockholders' equity (deficit):........................ -- Common stock -- amount paid in....................... 3,337 57,691 61,028 Accumulated deficit.................................. (37,854) 8,456(b) (29,398) Cumulative foreign currency transactions adjustment........................................ (143) (143) -------- ------- -------- Total stockholders' equity (deficit)......... (34,660) 66,147 31,487 -------- ------- -------- Total liabilities, convertible redeemable preferred stock and stockholders' equity (deficit).................................. $ 24,752 $ 14,977 $ 39,729 ======== ======= ========
See accompanying notes. F-3 74 VENTANA MEDICAL SYSTEMS, INC. UNAUDITED PRO FORMA CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS FOR THE YEAR ENDED DECEMBER 31, 1994 (IN THOUSANDS, EXCEPT PER SHARE DATA)
VENTANA BIOTEK PRO FORMA PRO FORMA HISTORICAL HISTORICAL(1) ADJUSTMENTS COMBINED ---------- ------------- ----------- --------- Net sales............................... $ 5,927 $ 5,642 $ 876(2) $ 12,445 Cost of goods sold...................... 2,531 3,643 (291)(2)(3) 5,883 ------- ------- ------- -------- Gross profit............................ 3,396 1,999 1,167 6,562 Operating expenses: Research and development.............. 1,926 785 (24)(3) 2,687 Selling, general and administrative... 6,899 4,636 (1,593)(2)(3)(4) 9,942 ------- ------- ------- -------- Loss from operations before nonrecurring expenses and amortization of intangibles........................... (5,429) (3,422) 2,784 (6,067) Nonrecurring expenses................... -- 877 7,496(5) 8,373 Amortization of intangibles............. -- -- 1,344(6) 1,344 ------- ------- ------- -------- Loss from operations.................... (5,429) (4,299) (6,056) (15,784) Interest expense........................ 59 (1,610) 1,610(7) 59 ------- ------- ------- -------- Net loss................................ $ (5,370) $(5,909) $(4,446) $ (15,725) ======= ======= ======= ========
See accompanying notes. F-4 75 VENTANA MEDICAL SYSTEMS, INC. UNAUDITED PRO FORMA CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS FOR THE YEAR ENDED DECEMBER 31, 1995 (IN THOUSANDS, EXCEPT PER SHARE DATA)
VENTANA BIOTEK PRO FORMA PRO FORMA HISTORICAL HISTORICAL(1) ADJUSTMENTS AS ADJUSTED ---------- ------------- ----------- ----------- Net sales.............................. $ 10,613 $ 6,920 $ 1,942(2) $19,475 Cost of goods sold..................... 4,282 4,294 520(2)(3) 9,096 ------- ------- ------ ------- Gross profit........................... 6,331 2,626 1,422 10,379 Operating expenses: Research and development............. 2,239 2,198 (30)(3) 4,407 Selling, general and administrative.................... 7,435 3,497 36(2)(3)(4) 10,968 ------- ------- ------ ------- Loss from operations before amortization of intangibles.......... (3,343) (3,069) 1,416 (4,996) Amortization of intangibles............ -- -- 1,344(6) 1,344 ------- ------- ------ ------- Loss from operations................... (3,343) (3,069) 72 (6,340) Interest (expense) income.............. 74 (2,224) 2,224(7) 74 ------- ------- ------ ------- Net loss............................... $ (3,269) $(5,293) $ 2,296 $(6,266) ======= ======= ====== ======= Pro forma net loss per share, as adjusted............................. $ (0.39) $ (0.66) ======= ======= Pro forma weighted average shares outstanding, as adjusted............. 8,354 9,466(8) ======= =======
See accompanying notes. F-5 76 VENTANA MEDICAL SYSTEMS, INC. UNAUDITED PRO FORMA CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS FOR THE THREE MONTHS ENDED MARCH 31, 1995 (IN THOUSANDS, EXCEPT PER SHARE DATA)
VENTANA BIOTEK PRO FORMA PRO FORMA HISTORICAL HISTORICAL(1) ADJUSTMENTS AS ADJUSTED ---------- ------------- ----------- ----------- Net sales................................ $ 2,202 $ 1,421 $ 795(2) $ 4,418 Cost of goods sold....................... 936 875 323(2)(3) 2,134 ------- ------ ---- ------- Gross profit............................. 1,266 546 472 2,284 Operating expenses: Research and development............... 556 173 (8)(3) 721 Selling, general and administrative.... 1,594 779 (6)(2)(3)(4) 2,367 ------- ------ ---- ------- Loss from operations before amortization of intangibles......................... (884) (406) 486 (804) Amortization of intangibles.............. -- -- 336(6) (336) ------- ------ ---- ------- Loss from operations..................... (884) (406) 150 (1,140) Interest (expense) income................ 50 (498) 498(7) 50 ------- ------ ---- ------- Net loss................................. $ (834) $ (904) $ 648 $(1,090) ======= ====== ==== ======= Pro forma net loss per share, as adjusted............................... $ (0.10) $ (0.12) ======= ======= Pro forma weighted average shares outstanding, as adjusted............... 8,220 9,331(8) ======= =======
See accompanying notes. F-6 77 VENTANA MEDICAL SYSTEMS, INC. UNAUDITED PRO FORMA CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS FOR THE THREE MONTHS ENDED MARCH 31, 1996 (IN THOUSANDS, EXCEPT PER SHARE DATA)
VENTANA BIOTEK PRO FORMA PRO FORMA HISTORICAL HISTORICAL(1) ADJUSTMENTS AS ADJUSTED ---------- ------------- ----------- ----------- Net sales............................. $ 4,146 $ 1,097 $ (15)(2) $ 5,228 Cost of goods sold.................... 1,435 593 (101)(2)(3) 1,927 -------- ------- ------- ------ Gross profit.......................... 2,711 504 86 3,301 Operating expenses: Research and development............ 613 163 (5)(3) 771 Selling, general and administrative................... 2,279 368 57(2)(3)(4) 2,704 -------- ------- ------- ------ Loss from operations before nonrecurring expenses and amortization of intangibles......... (181) (27) 34 (174) Nonrecurring expenses................. 7,083 413 (7,496)(5) -- Amortization of intangibles........... -- -- 336(6) 336 -------- ------- ------- ------ Loss from operations.................. (7,264) (440) 7,194 (510) Interest (expense) income............. (5) (944) 944(7) (5) -------- ------- ------- ------ Net loss.............................. $ (7,269) $(1,384) $ 8,138 $ (515) ======== ======= ======= ====== Pro forma net loss per share, as adjusted............................ $ (0.85) $ (0.05) ======== ====== Pro forma weighted average shares outstanding, as adjusted............ 8,585 9,696(8) ======== ======
See accompanying notes. F-7 78 VENTANA MEDICAL SYSTEMS, INC. NOTES TO UNAUDITED PRO FORMA CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (IN THOUSANDS, EXCEPT PER SHARE DATA) The Company acquired BioTek for $18.8 million on February 26, 1996. The pro forma results of operations reflect the Company's operations as if it had acquired BioTek on January 1, 1994 and are adjusted to reflect the sale of 2,200,000 shares of Common Stock by the Company in this Offering and the application of the net proceeds therefrom. The acquisition has been accounted for as a purchase. The composition of the consideration paid for BioTek and the preliminary allocation of the purchase price is presented below: The purchase price for BioTek consisted of: Cash consideration............................................. $ 2,500 Stock issued to BioTek noteholders............................. 3,007 Exchange Notes issued.......................................... 8,978 Note payable - escrow for contingencies........................ 234 Net historical liabilities acquired............................ 4,044 -------------- Total purchase price................................. $ 18,763 =========== The purchase price was allocated as follows: Tangible net assets.......................................... $ 2,288 In-process research and development.......................... 5,000 Goodwill..................................................... 1,875 Developed technology......................................... 2,000 Customer base................................................ 4,200 Covenant not to compete...................................... 1,800 Assembled work force......................................... 500 Trademark and trade names.................................... 1,100 -------------- $ 18,763 ===========
In accordance with FAS 2, the Company charged to expense at the date of the acquisition $5.0 million relating to the portion of the purchase price allocated to those in-process research and development projects where technological feasibility had not yet been established and where there are no alternative future uses. Intangible assets consist primarily of goodwill, customer base and developed technology. Such assets are amortized over estimated useful lives ranging from 3 to 20 years. BALANCE SHEET ADJUSTMENTS (a) Adjustment reflects net proceeds from the Offering to the Company after repayment of outstanding Exchange Notes and bank debt. (b) Adjustment reflects the automatic conversion of the Company's Preferred Stock into Common Stock upon completion of an initial public offering. The related accumulated unpaid dividends of approximately $8.5 million will be canceled upon such conversion. STATEMENT OF OPERATIONS ADJUSTMENTS (1) BioTek's historical fiscal year ended on June 30. BioTek's historical results of operations have been adjusted to a calendar year basis to conform with the reporting period of Ventana. (2) Adjustments reflect a change in revenue recognition policy to adopt the Company's policy of recording sales upon shipment of instruments and reagents to end-users. As such, the pro forma sales and related costs of goods sold reflect the accounting policy of recognizing revenue, for United States sales only, upon F-8 79 VENTANA MEDICAL SYSTEMS, INC. NOTES TO UNAUDITED PRO FORMA CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) (IN THOUSANDS, EXCEPT PER SHARE DATA) the ultimate sale of products to the end-users as if such policy had been in effect as of January 1, 1994. The combined effect of the pro forma change in accounting policy is to increase net sales in both 1994 and 1995. This is primarily due to (i) shipments of instruments and reagents to CMS in 1993 and 1994 which were subsequently placed with end-users in 1994 and 1995 and (ii) recording sales based on prices paid by the end-user as opposed to the net price paid by CMS. Accordingly, cost of goods sold has been adjusted to reflect the differences in the timing of sales and the mix of products sold, and selling expense has been increased to reflect the distribution commission paid to CMS. The commission is equal to the product of (i) the number of units shipped to end-users and (ii) the difference between the price paid by the end-user to CMS and the net price paid by CMS to the Company. (3) Adjustments reflect expense reductions associated with the consolidation of manufacturing facilities into Ventana's facilities in Tucson, Arizona. Effective September 1996, the Santa Barbara facility will no longer be used. The resulting cost reductions from the facilities consolidation are allocated among cost of goods sold (50%), research and development expense (10%), and selling, general, and administrative expense (40%). (4) Reductions in selling, general, and administrative expense reflect (i) an increase in distribution expense associated with the change in revenue recognition policy discussed in footnote (2) above, (ii) the consolidation of the sales and marketing organizations of Ventana and BioTek, and (iii) the elimination of certain redundant administrative positions. A summary of the net savings recognized in the pro forma selling, general and administrative expense follows:
THREE MONTHS YEAR ENDED ENDED DECEMBER 31, MARCH 31, ----------------- ------------- 1994 1995 1995 1996 ------- ------- ----- ----- Distribution expense................................. $ 1,004 $ 1,038 $ 286 $ 166 Sales and marketing.................................. (1,331) (92) (75) 44 General and administrative........................... (1,266) (910) (217) (153) ------- ------- ----- ----- $(1,593) $ 36 $ (6) $ 57 ======= ======= ===== =====
(5) Adjustments for nonrecurring expenses reflect $5.0 million for acquired in-process research and development which was charged to expense in accordance with FAS 2, $2.1 million associated with the acquisition and integration of BioTek, and $0.4 million in fees incurred related to the BioTek acquisition. These charges were incurred in the first quarter of 1996 and are reflected as if such charges had been incurred in the year ended December 31, 1994. (6) Adjustment for amortization of intangibles arising from the BioTek acquisition. (7) Adjustment to eliminate interest expense on BioTek's debt as a result of the merger and the retirement of debt with the net proceeds from the Offering. F-9 80 VENTANA MEDICAL SYSTEMS, INC. NOTES TO UNAUDITED PRO FORMA CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) (IN THOUSANDS, EXCEPT PER SHARE DATA) (8) The calculation of pro forma weighted average number of shares outstanding is as follows:
THREE MONTHS ENDED YEAR ENDED MARCH 31, DECEMBER 31, --------------- 1995 1995 1996 ------------ ----- ----- Weighted average shares outstanding.................... 957 903 1,119 Assumed conversion of Series A, C, and D preferred shares............................................... 6,580 6,499 6,648 Assumed exercise of warrants to purchase Series D preferred shares..................................... 48 48 48 Stock options and restricted stock issued within one year of initial filing............................... 769 769 769 Shares of common stock issued in connection with the initial public offering to be used to retire acquisition debt..................................... 1,112 1,112 1,112 ------ ----- ----- Weighted average shares outstanding, as adjusted....... 9,466 9,331 9,696 ========== ===== =====
F-10 81 REPORT OF ERNST & YOUNG LLP, INDEPENDENT AUDITORS Board of Directors Ventana Medical Systems, Inc. We have audited the accompanying consolidated balance sheets of Ventana Medical Systems, Inc., as of December 31, 1994 and 1995, and the related consolidated statements of operations, convertible redeemable preferred stock and stockholders' equity (deficit), and cash flows for each of the three years in the period ended December 31, 1995. These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on these financial statements based on our audits. We conducted our audits in accordance with generally accepted auditing standards. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion. In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the consolidated financial position of Ventana Medical Systems, Inc., as of December 31, 1994 and 1995, and the consolidated results of their operations and their cash flows for the three years in the period ended December 31, 1995 in conformity with generally accepted accounting principles. Tucson, Arizona February 28, 1996, except for Note 10, as to which the date is , 1996 --------------------------------------------- The foregoing report is in the form that will be signed upon completion of the recapitalization described in Note 10 to the Consolidated Financial Statements. Tucson, Arizona May 21, 1996 F-11 82 VENTANA MEDICAL SYSTEMS, INC. CONSOLIDATED BALANCE SHEETS (IN THOUSANDS, EXCEPT SHARE DATA) ASSETS
DECEMBER 31, PRO FORMA --------------------- STOCKHOLDERS' 1994 1995 EQUITY (DEFICIT) -------- -------- MARCH 31, 1996 MARCH 31, ---------------- 1996 ----------- (UNAUDITED) (UNAUDITED) Current assets: Cash and cash equivalents.................. $ 2,511 $ 1,103 $ 3,436 Accounts receivable........................ 1,451 1,925 2,834 Inventories (Note 2)....................... 893 1,767 2,472 Other...................................... 38 24 695 -------- -------- ----------- Total current assets......................... 4,893 4,819 9,437 Property and equipment, net (Note 3)......... 2,169 2,258 2,923 Intangibles, net (Note 10)................... 217 301 12,392 -------- -------- ----------- Total assets................................. $ 7,279 $ 7,378 $ 24,752 ======== ======== ========= LIABILITIES, CONVERTIBLE REDEEMABLE PREFERRED STOCK, AND STOCKHOLDERS' EQUITY (DEFICIT) Current liabilities: Accounts payable........................... $ 639 $ 1,061 $ 1,216 Other current liabilities (Note 4)......... 534 993 7,026 -------- -------- ----------- Total current liabilities.................... 1,173 2,054 8,242 Long-term debt............................... -- -- 15,035 Commitments (Notes 6, 9 and 10) Convertible redeemable preferred stock at aggregate mandatory redemption value (Notes 6 and 10):................................. 30,237 35,180 36,135 $ -- Stockholders' equity (deficit) (Notes 7 and 10): Preferred stock -- $.001 par value; no shares authorized, issued or outstanding (5,000,000 shares authorized, no shares issued or outstanding at March 31, 1996 -- pro forma)...................... -- -- -- -- Common stock -- $.001 par value; 30,000,000 shares authorized, 875,005, 1,020,164, and 1,347,049 shares issued and outstanding at December 31, 1994 and 1995 and March 31, 1996, respectively (50,000,000 shares authorized, 8,008,890 shares issued and outstanding -- pro forma) -- amount paid in................ 190 244 3,337 31,016 Accumulated deficit........................ (24,275) (29,980) (37,854) (29,398) Cumulative foreign currency translation adjustment.............................. (46) (120) (143) (143) -------- -------- ----------- ---------------- Total stockholders' equity (deficit)......... (24,131) (29,856) (34,660) $ 1,475 ============ -------- -------- ----------- Total liabilities, convertible redeemable preferred stock, and stockholders' equity (deficit).................................. $ 7,279 $ 7,378 $ 24,752 ======== ======== =========
See accompanying notes. F-12 83 VENTANA MEDICAL SYSTEMS, INC. CONSOLIDATED STATEMENTS OF OPERATIONS (IN THOUSANDS, EXCEPT PER SHARE DATA)
YEARS ENDED THREE MONTHS ENDED DECEMBER 31, MARCH 31, --------------------------------- --------------------- 1993 1994 1995 1995 1996 --------- --------- --------- --------- --------- (UNAUDITED) Net sales................................. $ 2,681 $ 5,927 $ 10,613 $ 2,202 $ 4,146 Cost of goods sold........................ 1,722 2,531 4,282 936 1,435 --------- --------- --------- --------- --------- 959 3,396 6,331 1,266 2,711 Operating expenses: Research and development................ 2,100 1,926 2,239 556 613 Selling, general and administrative..... 4,067 6,899 7,435 1,594 2,279 --------- --------- --------- --------- --------- Loss from operations before non-recurring expenses................................ (5,208) (5,429) (3,343) (884) (181) Nonrecurring expenses..................... -- -- -- -- (7,083) --------- --------- --------- --------- --------- Loss from operations...................... (5,208) (5,429) (3,343) (884) (7,264) Interest income (expense)................. 229 59 74 50 (5) --------- --------- --------- --------- --------- Net loss.................................. $ (4,979) $ (5,370) $ (3,269) $ (834) $ (7,269) ======== ======== ======== ======== ======== Net loss per share, as adjusted........... $ (0.39) $ (0.10) $ (0.85) ======== ======== ======== Shares used in computing net loss per share, as adjusted...................... 8,354 8,220 8,585 ======== ======== ========
See accompanying notes. F-13 84 VENTANA MEDICAL SYSTEMS, INC. CONSOLIDATED STATEMENTS OF CONVERTIBLE REDEEMABLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT) (IN THOUSANDS, EXCEPT SHARE DATA)
STOCKHOLDERS' EQUITY (DEFICIT) ------------------------------------------------------------ CUMULATIVE CONVERTIBLE REDEEMABLE FOREIGN PREFERRED STOCK COMMON STOCK CURRENCY ------------------------------------------- -------------------- ACCUMULATED TRANSLATION SERIES A SERIES C SERIES D TOTAL SHARES AMOUNT DEFICIT ADJUSTMENT TOTAL --------- --------- --------- ------- --------- -------- ------------ ----------- -------- Balance at January 1, 1993............... $ 536 $ 8,731 $ 9,034 $18,301 820,294 $ 165 $(10,147) $ -- $ (9,982) Sale of Series D preferred stock.. -- -- 5,117 5,117 -- -- -- -- -- Accretion of preferred stock redemption requirement...... -- 656 1,140 1,796 -- -- (1,796) -- (1,796) Sale of common stock............ -- -- -- -- 88,800 33 -- -- 33 Repurchase of stock............ -- (2) -- (2) (924) (1) -- -- (1) Net loss............. -- -- -- -- -- -- (4,979) -- (4,979) --------- --------- --------- ------- --------- -------- ------------ ----------- -------- Balance at December 31, 1993........... 536 9,385 15,291 25,212 908,170 197 (16,922) -- (16,725) Sale of Series D preferred stock.. -- -- 3,042 3,042 -- -- -- -- -- Accretion of preferred stock redemption requirement...... -- 656 1,327 1,983 -- -- (1,983) -- (1,983) Sale of common stock............ -- -- -- -- 29,199 8 -- -- 8 Repurchase of common stock..... -- -- -- -- (62,364) (15) -- -- (15) Translation adjustment....... -- -- -- -- -- -- -- (46) (46) Net loss........... -- -- -- -- -- -- (5,370) -- (5,370) --------- --------- --------- ------- --------- -------- ------------ ----------- -------- Balance at December 31, 1994........... 536 10,041 19,660 30,237 875,005 190 (24,275) (46) (24,131) Sale of Series D preferred stock.. -- -- 2,507 2,507 -- -- -- -- -- Accretion of preferred stock redemption requirement...... -- 655 1,781 2,436 -- -- (2,436) -- (2,436) Sale of common stock............ -- -- -- -- 160,210 67 -- -- 67 Repurchase of common stock..... -- -- -- -- (15,051) (13) -- -- (13) Translation adjustment....... -- -- -- -- -- -- -- (74) (74) Net loss........... -- -- -- -- -- -- (3,269) -- (3,269) --------- --------- --------- ------- --------- -------- ------------ ----------- -------- Balance at December 31, 1995........... 536 10,696 23,948 35,180 1,020,164 244 (29,980) (120) (29,856) Sale of Series D preferred stock (unaudited)...... -- -- 350 350 -- -- -- -- -- Accretion of preferred stock redemption requirement (unaudited)...... -- 163 442 605 -- -- (605) -- (605) Conversion of debt into common stock (unaudited)...... -- -- -- -- 225,100 3,007 -- -- 3,007 Sale of common stock (unaudited)...... -- -- -- -- 101,785 86 -- -- 86 Translation adjustment (unaudited)...... -- -- -- -- -- -- -- (23) (23) Net loss (unaudited)...... -- -- -- -- -- -- (7,269) -- (7,269) --------- --------- --------- ------- --------- -------- ------------ ----------- -------- Balance at March 31, 1996 (unaudited)... $ 536 $10,859 $24,740 $36,135 1,347,049 $ 3,337 $(37,854) $(143) $(34,660) ======== ======== ======== ======== ========= ========= ============ ========== =========
See accompanying notes. F-14 85 VENTANA MEDICAL SYSTEMS, INC. CONSOLIDATED STATEMENTS OF CASH FLOWS (IN THOUSANDS)
YEARS ENDED THREE MONTHS ENDED DECEMBER 31, MARCH 31, ------------------------------- ------------------- 1993 1994 1995 1995 1996 ------- ------- ------- ------ -------- (UNAUDITED) OPERATING ACTIVITIES: Net loss................................. $(4,979) $(5,370) $(3,269) $ (834) $ (7,269) Adjustments to reconcile net loss to net cash used in operating activities: Purchased in-process research and development......................... -- -- -- -- 5,000 Depreciation and amortization.......... 334 477 911 211 252 Changes in operating assets and liabilities: Accounts receivable.................... (244) (941) (474) 165 (287) Inventories............................ (258) (24) (874) (64) (577) Other assets........................... (126) 37 (114) (39) (37) Accounts payable....................... 69 321 422 48 (344) Other current liabilities.............. 110 224 459 132 2,409 ------- ------- ------- ------ -------- Net cash used in operating activities.... (5,094) (5,276) (2,939) (381) (853) INVESTING ACTIVITIES: Purchase of property and equipment, net.................................... (1,700) (604) (956) (399) (59) Acquisition of BioTek Solutions, Inc..... -- -- -- -- (2,500) Sales (purchases) of short-term investments available for sale......... (4,063) 4,063 -- -- -- ------- ------- ------- ------ -------- Net cash (used in) provided by investing activities............................. (5,763) 3,459 (956) (399) (2,559) FINANCING ACTIVITIES: Repayments of notes payable.............. (42) (36) -- -- -- Issuance of debt (including amounts from related parties) and stock............. 5,147 3,035 2,561 2,415 5,722 ------- ------- ------- ------ -------- Net cash provided by financing activities............................. 5,105 2,999 2,561 2,415 5,722 Effect of exchange rate changes on cash................................... -- (46) (74) -- 23 ------- ------- ------- ------ -------- Net (decrease) increase in cash and cash equivalents............................ (5,752) 1,136 (1,408) 1,635 2,333 Cash and cash equivalents, beginning of period................................. 7,127 1,375 2,511 2,511 1,103 ------- ------- ------- ------ -------- Cash and cash equivalents, end of period................................. $ 1,375 $ 2,511 $ 1,103 $4,146 $ 3,436 ======= ======= ======= ====== ========
See accompanying notes. F-15 86 VENTANA MEDICAL SYSTEMS, INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 1995 (INFORMATION FOR THE PERIODS ENDED MARCH 31, 1995 AND 1996 IS UNAUDITED) 1. ORGANIZATION AND SIGNIFICANT ACCOUNTING POLICIES Organization: Ventana Medical Systems, Inc. (the "Company") develops, manufactures, and markets proprietary instruments and reagents that automate diagnostic procedures used for molecular analysis of cells. Subsequent to year end, the Company acquired all of the outstanding common stock of Biotek Solutions, Inc. ("Biotek"). See Note 10 for discussion of the Company's acquisition of Biotek. At present, the Company's principal markets are North America and Europe. Principles of Consolidation: The consolidated financial statements include the accounts of the Company's wholly-owned foreign subsidiaries, Ventana Medical Systems, S.A. and Ventana Medical Systems GmbH. All significant intercompany accounts have been eliminated. Interim Consolidated Financial Information: The consolidated financial statements at March 31, 1996 and for the three months ended March 31, 1995 and 1996 are unaudited, but include all adjustments (consisting only of normal recurring adjustments) that management considers necessary for a fair presentation of the financial information set forth therein, in accordance with generally accepted accounting principles. The results for the three months ended March 31, 1996 are not necessarily indicative of the results for the entire year. Reclassifications: The consolidated financial statements for 1993 and 1994 have been reclassified to conform with the 1995 presentation. Cash and Cash Equivalents: Cash equivalents include investments (primarily money market accounts and overnight reverse repurchase agreements) with maturities of three months or less from the date of purchase. On December 31, 1994, the Company purchased $2.1 million of U.S. Government Securities from Bank One, Arizona (the "Bank") under an agreement to resell such securities. The Company did not take possession of the securities which were instead held in the Company's safekeeping account at the Bank. The amortized cost of this investment approximates the market value. Inventories: Inventories, principally chemical and biological reagents and instrument parts and finished instruments, are stated at the lower of cost (first-in first-out) or market. Property and Equipment: Property and equipment are stated at cost. Depreciation is computed using the straight-line method over estimated useful lives of three to ten years. Amortization of leasehold improvements is calculated using a straight-line method over the term of the lease. Maintenance and repairs are charged to operations as incurred. Diagnostic instruments include automated instruments used by customers under cancelable reagent agreement plans, which generally are cancelable upon 90 days written notice. These agreements also require the customer to purchase a specified amount of reagents for tests from the Company over the term of the agreement. The manufacturing cost of the related instruments is amortized over a period of 36 to 48 months and charged to cost of goods sold. Diagnostic instruments also include instruments placed with customers for evaluation or demonstration as part of the Company's sales process. F-16 87 VENTANA MEDICAL SYSTEMS, INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) DECEMBER 31, 1995 (INFORMATION FOR THE PERIODS ENDED MARCH 31, 1995 AND 1996 IS UNAUDITED) Intangibles: Intangible assets consist primarily of goodwill, customer base, and developed technology acquired in the BioTek acquisition (see Note 10). Such assets are amortized over estimated useful lives ranging from 3 to 20 years. Revenue Recognition: Sales of instruments and reagents are generally recognized upon shipment. Concentration of Credit Risk: The Company sells its instruments and reagent products primarily to hospitals, medical clinics, reference laboratories, and universities. Credit losses have been minimal to date. The Company invests its excess cash primarily in U.S. government securities and has an established policy relating to diversification and maturities that is designed to maintain safety and liquidity. The Company has not experienced any material losses on its cash equivalents or short-term investments. Nonrecurring Expenses: Nonrecurring expenses consist of the estimated costs of integrating Biotek's operations into Ventana's and the cost of research and development in process acquired from Biotek (see Note 10). Income Taxes: The Company accounts for income taxes using the liability method. Deferred tax assets and liabilities are determined based on differences between financial reporting and tax bases of assets and liabilities and are measured using enacted tax rates and laws expected to be in effect when the differences are expected to reverse. Valuation allowances are established when necessary to reduce the carrying amount of deferred tax assets to their net realizable value. Use of Estimates: The preparation of financial statements in accordance with generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Fair Value of Financial Instruments: The Company's cash, accounts receivable, and convertible redeemable preferred stock represent financial instruments as defined by Statement of Financial Accounting Standards No. 107, Disclosures About Fair Value of Financial Instruments. The carrying value of these financial instruments is a reasonable approximation of fair value. Stock-Based Compensation: The Company accounts for its stock compensation arrangements under the provisions of APB No. 25, Accounting for Stock Issued to Employees, and intends to continue to do so. Loss Per Common Share: Loss per common share is computed using the weighted average number of shares of common stock outstanding, except as noted below. Common equivalent shares from stock options and warrants are excluded from the computation as their effect is antidilutive, except that, pursuant to the Securities and Exchange Commission Staff Accounting Bulletins and Staff policy, common and common equivalent shares issued during the period commencing 12 months prior to the initial filing of the proposed initial public offering at prices below the anticipated public offering price are presumed to have been in contemplation of the public offering and have been included in the calculation as if they were outstanding for all periods presented, determined using the treasury stock method and the anticipated price from the initial public offering. F-17 88 VENTANA MEDICAL SYSTEMS, INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) DECEMBER 31, 1995 (INFORMATION FOR THE PERIODS ENDED MARCH 31, 1995 AND 1996 IS UNAUDITED) Net loss per common share was as follows:
YEARS ENDED THREE MONTHS ENDED DECEMBER 31, MARCH 31, --------------------------------- --------------------- 1993 1994 1995 1995 1996 --------- --------- --------- --------- --------- (IN THOUSANDS) Net loss.................................. $ (4,979) $ (5,370) $ (3,269) $ (834) $ (7,269) Less accretion of preferred stock redemption requirement.................. (1,796) (1,983) (2,436) (579) (605) --------- --------- ---------- ---------- Net loss applicable to common stock....... $ (6,775) $ (7,353) $ (5,705) $ (1,413) $ (7,874) ========= ========= ========== ========== Net loss per common share................. $ (4.17) $ (4.36) $ (3.30) $ (0.84) $ (4.17) ========= ========= ========== ========== Weighted average shares outstanding....... 1,626 1,686 1,727 1,672 1,889 ========= ========= ========== ==========
The as adjusted calculation of net loss per share presented in the consolidated statements of operations has been computed as described above, but also gives effect to the conversion of all outstanding shares of convertible redeemable preferred stock into common stock upon closing of the Company's initial public offering (determined using the if-converted method) and the assumed exercise of warrants to purchase Series D preferred stock which would otherwise expire upon completion of the Offering. 2. INVENTORIES Inventories consist of the following:
DECEMBER 31, --------------- MARCH 31, 1994 1995 1996 ---- ------ --------- (IN THOUSANDS) Raw materials and work-in-process...................... $752 $1,265 $ 1,330 Finished goods......................................... 141 502 1,142 ---- ------ ------ $893 $1,767 $ 2,472 ==== ====== ======
3. PROPERTY AND EQUIPMENT Property and equipment consist of the following:
DECEMBER 31, ----------------- MARCH 31, 1994 1995 1996 ------ ------ --------- (IN THOUSANDS) Diagnostic instruments........................... $1,544 $2,008 $ 2,180 Machinery and equipment.......................... 1,356 1,501 2,340 Computers and related equipment.................. 187 284 275 Furniture and fixtures........................... 116 272 273 Leasehold improvements........................... 39 133 133 ------ ------ ------ 3,242 4,198 5,201 Less accumulated depreciation and amortization........ 1,073 1,940 2,278 ------ ------ ------ $2,169 $2,258 $ 2,923 ====== ====== ======
F-18 89 VENTANA MEDICAL SYSTEMS, INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) DECEMBER 31, 1995 (INFORMATION FOR THE PERIODS ENDED MARCH 31, 1995 AND 1996 IS UNAUDITED) 4. OTHER CURRENT LIABILITIES Other current liabilities consist of the following:
DECEMBER 31, ------------- MARCH 31, 1994 1995 1996 ---- ---- --------- (IN THOUSANDS) Accrued payroll and payroll taxes................ $205 $289 $ 630 Accrued commissions.............................. 150 198 38 Deferred revenue................................. 46 127 1,955 Advances from distributor........................ -- -- 1,733 Accrued integration costs........................ -- -- 750 Accrued legal fees and settlement costs.......... -- -- 600 Sales tax payable................................ -- 167 312 Other accrued expenses........................... 133 212 1,008 ---- ---- ------ $534 $993 $ 7,026 ==== ==== ======
5. LINE OF CREDIT During 1995, the Company had $2.75 million available under a line of credit arrangement with a bank. Borrowings under the line are collateralized by the Company's receivables and intellectual property. The line contains certain financial covenants with which the Company must comply. No borrowings were outstanding under the line at December 31, 1995. Subsequent to year end, this arrangement was amended (see Note 10). 6. CONVERTIBLE REDEEMABLE PREFERRED STOCK Each share of Series A, C and D preferred stock is convertible, at the option of the holder, into approximately 0.37 share of common stock (subject to adjustments for events of dilution). Shares are automatically converted upon a public offering of common stock meeting specified criteria, which principally are a minimum amount of proceeds and price per share levels. Each share of preferred stock has the same voting rights as common stock and is entitled to the same number of votes as shares of common stock into which it is convertible. Subsequent to payment of all accumulated dividends, any dividend declared or paid would be pro rata and for preferred shares, would be based upon the number of shares of common stock into which such preferred shares are convertible. The holders of at least 50% of the outstanding preferred stock may request the Company to redeem 1/8 of the outstanding preferred stock each quarter beginning June 30, 1997. The redemption price of Series A preferred stock is $0.715 per share. The redemption prices for Series C and D preferred stock are $0.90 per share and $2.15 per share, respectively, plus accumulated unpaid dividends. If funds are not available for such redemptions, the shares must be redeemed as soon as funds are legally available. F-19 90 VENTANA MEDICAL SYSTEMS, INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) DECEMBER 31, 1995 (INFORMATION FOR THE PERIODS ENDED MARCH 31, 1995 AND 1996 IS UNAUDITED) The following is a summary of mandatory redemption value, accumulated unpaid dividends and authorized, issued, and outstanding shares:
DECEMBER 31, ------------------------------------------- MARCH 31, 1993 1994 1995 1996 ----------- ----------- ----------- ----------- (IN THOUSANDS, EXCEPT SHARE DATA) Series A (non-cumulative): Mandatory redemption................ $ 536 $ 536 $ 536 $ 536 Authorized, issued and outstanding shares........................... 750,000 750,000 750,000 750,000 Series C (9% cumulative): Mandatory redemption, including accumulated dividends............ $ 9,385 $ 10,041 $ 10,696 $ 10,859 Accumulated dividends............... $ 2,109 $ 2,765 $ 3,420 $ 3,583 Authorized shares................... 8,300,000 8,300,000 8,300,000 8,300,000 Issued and outstanding shares....... 8,083,039 8,084,543 8,084,543 8,084,543 Series D (9% cumulative): Mandatory redemption, including accumulated dividends............ $ 15,291 $ 19,660 $ 23,948 $ 24,740 Accumulated dividends............... $ 1,338 $ 2,650 $ 4,431 $ 4,873 Authorized shares................... 6,750,000 10,250,000 10,250,000 10,250,000 Issued and outstanding shares....... 6,489,954 7,911,836 9,098,741 9,191,764 Totals Mandatory redemption, including accumulated dividends............ $ 25,212 $ 30,237 $ 35,180 $ 36,135 Accumulated dividends............... $ 3,447 $ 5,415 $ 7,851 $ 8,456 Authorized shares................... 15,800,000 19,300,000 19,300,000 19,300,000 Issued and outstanding shares....... 15,322,993 16,746,379 17,933,284 18,026,307
In the event of the conversion of convertible redeemable preferred stock into common stock as a result of a public offering, all accumulated unpaid dividends on the preferred stock are canceled. In the event of a liquidation or merger, the preferred stockholders would receive $0.65 per share of Series A preferred stock, $0.90 per share plus any accumulated unpaid dividends for Series C preferred stock, and $2.15 per share plus any accumulated unpaid dividends for Series D preferred stock prior to any distribution to the common stockholders. If the assets of the Company are insufficient to permit the payment of the full amount of the liquidation preference to the preferred stockholders, the assets of the Company would be distributed to the preferred stockholders in proportion to the total number of preferred shares then outstanding. The articles of incorporation and the preferred stock agreements require the Company to meet certain provisions related to transaction and debt restrictions, stock dilution, redemption payments and administrative restrictions. If such requirements are not met, the holders of at least 50% of the outstanding preferred stock may request an increase in the number of directors of the Company's Board of Directors as would constitute a minimum majority and the holders of preferred stock, voting separately as a single class, may elect individuals to fill such newly created directorships. All preferences, covenants, and other provisions terminate upon an initial public offering. F-20 91 VENTANA MEDICAL SYSTEMS, INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) DECEMBER 31, 1995 (INFORMATION FOR THE PERIODS ENDED MARCH 31, 1995 AND 1996 IS UNAUDITED) Through the Company's 1991 Employee Qualified Stock Purchase Plan (the "1991 Purchase Plan"), employees of the Company are able to purchase Series D preferred stock through accumulated payroll deductions for $2.15 per share. A total of 250,000 shares of Series D preferred stock have been reserved for issuance under this plan. Shares of 222,987 were issued and outstanding at December 31, 1995, which are convertible into 92,391 shares of common stock. Warrants for the purchase of 228,914 shares of Series D preferred stock are outstanding at December 31, 1995, with exercise prices of $2.15 per share. Such warrants will expire upon an initial public offering, to the extent not previously exercised and are convertible into 82,408 shares of common stock. 7. COMMON STOCK 1988 Stock Option Plan: Under the Company's 1988 Stock Option Plan (the "Plan"), incentive and non-qualified stock options for the purchase of up to 1,339,663 shares of common stock are reserved for grant to employees and directors. Options must be granted at not less than 100% of fair market value (as determined by the Board of Directors) at the date of grant. Options generally vest over a four year period and expire five to ten years after the date of grant. However, the Board of Directors, at its discretion, may decide the period over which options become exercisable and their expiration dates. A summary of stock option activity is as follows:
OUTSTANDING STOCK OPTIONS ----------------------------- NUMBER OF EXERCISE OPTIONS PRICE PER SHARE --------- --------------- Balance at January 1, 1993........................ 312,092 $0.18 -- $0.60 Granted......................................... 44,717 0.60 -- 0.95 Exercised....................................... (54,987) 0.18 -- 0.24 Canceled........................................ (28,836) 0.24 -- 0.60 --------- --------- Balance at December 31, 1993...................... 272,986 0.18 -- 0.95 Granted......................................... 564,836 0.84 -- 0.95 Exercised....................................... (28,090) 0.24 -- 0.95 Canceled........................................ (196,955) 0.18 -- 0.95 --------- --------- Balance at December 31, 1994...................... 612,777 0.24 -- 0.95 Granted......................................... 324,467 0.84 Exercised....................................... (160,210) 0.24 -- 0.95 Canceled........................................ (126,580) 0.24 -- 0.95 --------- --------- Balance at December 31, 1995...................... 650,454 0.24 -- 0.95 Granted......................................... 69,256 1.62 Exercised....................................... (7,616) 0.24 -- 0.95 Canceled........................................ (9,429) 0.60 -- 0.84 --------- --------- Balance at March 31, 1996......................... 702,665 $0.24 -- $1.62 ========= =========
Options to purchase 133,716 shares of common stock were immediately exercisable at December 31, 1995. F-21 92 VENTANA MEDICAL SYSTEMS, INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) DECEMBER 31, 1995 (INFORMATION FOR THE PERIODS ENDED MARCH 31, 1995 AND 1996 IS UNAUDITED) 8. INCOME TAXES The Company's deferred tax assets consist of the following:
DECEMBER 31, ------------------- 1994 1995 ------- ------- (IN THOUSANDS) Non-current: Net operating loss carryforwards....................... $ 4,345 $ 5,004 Capitalized research and development................... 2,256 2,471 General business credit carryforwards.................. 617 767 Other.................................................. 67 186 Current: Miscellaneous.......................................... 19 154 ------ ------ Total deferred tax assets................................ 7,304 8,582 Valuation allowance...................................... (7,304) (8,582) ------ ------ Net deferred tax assets.................................. $ -- $ -- ====== ======
The valuation allowance for deferred tax assets was increased by $5,500,000, $1,843,000, and $1,319,000 in the years ended December 31, 1993, 1994, and 1995, respectively to fully offset deferred tax balances. Temporary differences between the net operating losses for financial reporting and income tax purposes primarily relate to the deferral of research and development expenses for tax purposes. At December 31, 1995, the Company has net operating loss carryforwards for federal and state purposes of approximately $12.0 million. These federal and state carryforwards will begin to expire in 2000 and 1996, respectively, if not previously utilized. The Company also has research and development tax credit carryforwards of approximately $700,000 which will begin to expire in 2005, if not previously utilized. Utilization of the Company's net operating loss carryforwards will be subject to limitations due to the "change in ownership" provisions of the Internal Revenue Code of 1996, as amended, as a result of the Company's prior issuances of equity securities. These carryforwards, therefore, may expire prior to being fully utilized. Future financings may cause additional changes in ownership and further limitations on the use of federal net operating loss carryforwards. 9. OPERATING LEASES The Company conducts its corporate operations from leased facilities. In addition to monthly rental payments, the Company is responsible for certain monthly operating and maintenance expenses of such facilities. The lease expires in 2001. The future minimum rental payments under this and other operating lease arrangements are as follows (in thousands): 1996.................................................. $185 1997.................................................. 151 1998.................................................. 137 1999.................................................. 245 2000.................................................. 289 Thereafter............................................ 72
Rent expense totaled $125,000, $157,000 and $188,000 for the years ended December 31, 1993, 1994 and 1995, respectively. F-22 93 VENTANA MEDICAL SYSTEMS, INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) DECEMBER 31, 1995 (INFORMATION FOR THE PERIODS ENDED MARCH 31, 1995 AND 1996 IS UNAUDITED) 10. SUBSEQUENT EVENTS In April 1996, the Company's Board of Directors authorized the Company to file a Registration Statement with the Securities and Exchange Commission to sell shares of its common stock in an underwritten public offering. The Company's Board of Directors also approved a reduction in the number of authorized shares of undesignated preferred stock to 5,000,000 and an increase in the number of authorized shares of common stock to 50,000,000. Unaudited pro forma stockholders' equity, as adjusted for the assumed conversion of the Preferred Stock and concurrent cancellation of undeclared dividends of $8,456,000, is set forth on the accompanying consolidated balance sheet. In conjunction with the proposed Offering, the Board of Directors authorized a 1-for-2.7059046 reverse split of its common stock to be effected prior to the closing of the offering. The accompanying consolidated financial statements have been adjusted retroactively to reflect the reverse split of the common stock. The conversion ratios of the respective series of convertible preferred stock were automatically adjusted to reflect the reverse split. If the Offering is consummated under terms presently anticipated, all of the currently outstanding preferred stock will automatically convert into 6,661,841 shares of common stock, and 84,598 shares of common stock will be issued due to warrant exercises. Unaudited pro forma stockholders' equity as adjusted for the assumed conversion (but not for the exercise of outstanding warrants) is set forth in the accompanying balance sheet. The Company acquired BioTek for $18.8 million on February 26, 1996. The acquisition has been accounted for as a purchase. The purchase price for BioTek consisted of:
(IN THOUSANDS) Cash consideration............................. $ 2,500 Stock issued to BioTek noteholders............. 3,007 Exchange Notes issued.......................... 8,978 Note payable -- escrow for contingencies....... 234 Net historical liabilities assumed............. 4,044 ------- $ 18,763 =======
The purchase price was allocated as follows:
(IN THOUSANDS) Tangible net assets............................ $ 2,288 In-process research and development............ 5,000 Goodwill....................................... 1,875 Developed technology........................... 2,000 Customer base.................................. 4,200 Covenant not-to-compete........................ 1,800 Assembled work force........................... 500 Trademark and trade name....................... 1,100 ------ Total purchase price........................... $ 18,763 ======
The Company charged to expense at the date of the acquisition $5.0 million relating to the portion of the purchase price allocated to those in-process research and development projects where technological feasibility had not yet been established and where there are no alternative future uses. F-23 94 VENTANA MEDICAL SYSTEMS, INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) DECEMBER 31, 1995 (INFORMATION FOR THE PERIODS ENDED MARCH 31, 1995 AND 1996 IS UNAUDITED) The Exchange Notes were convertible into the Company's common stock for 30 days subsequent to the acquisition. As of March 25, 1996 approximately $3,007,000 of the Exchange Notes were converted into the Company's common stock. The Exchange Notes are payable at the earlier of 30 days after an initial public offering of the Company's common stock of at least $20 million or February 1998. The Exchange Notes bear interest at 7% payable on December 31, 1996 and 1997. The December 31, 1996 interest payment may be made in cash or common stock, at the Company's option. If the Notes are redeemed prior to December 31, 1996, no interest is payable. On March 15, 1996, the Company amended its borrowing agreement with its bank. The Company obtained a lending commitment for $2.0 million under a term loan with interest at the bank's prime rate plus 2.0%. The Company will make monthly interest payments on amounts borrowed through March 1997, at which time any amount borrowed plus accrued interest must be repaid in 24 equal monthly installments. The Company's line of credit was extended through March 1997. During the quarter ended March 31, 1996, the Company raised $4.6 million through the private placement of subordinated notes which included warrants to purchase an aggregate of 2,378,898 shares of Preferred Stock of the Company at an exercise price of $2.15 per share which will convert into 879,183 shares of Common Stock upon the completion of this Offering. The proceeds of these notes were used to fund the cash portion of the BioTek acquisition consideration and to provide working capital. These notes bear interest at 7% per annum, which will be forgiven if the notes are repaid prior to December 31, 1996. The subordinated notes are required to be repaid by the Company within 30 days of the completion of this Offering. On February 26, 1996, the Company sold 646,659 shares of common stock to two directors of the Company and a related partnership at a price of $1.62 per share for their efforts and assistance in completing the BioTek acquisition and assisting management with its integration of the companies. These shares are subject to buyback by the Company at the issuance price for various periods. These buyback provisions lapse upon successful completion of an initial public offering or sale of the Company for a price of at least $10.82 per share. In May 1996, the Company established the 1996 Stock Option Plan (the "1996 Stock Plan") and reserved 1,000,000 shares of common stock for issuance. No options to purchase shares of common stock have been granted. F-24 95 VENTANA MEDICAL SYSTEMS, INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) DECEMBER 31, 1995 (INFORMATION FOR THE PERIODS ENDED MARCH 31, 1995 AND 1996 IS UNAUDITED) In May 1996, the Board of Directors authorized the 1996 Employee Stock Purchase Plan (the "1996 Purchase Plan"). A total of 200,000 shares of common stock are reserved for issuance under the 1996 Purchase Plan. No shares have been issued under the 1996 Purchase Plan. The 1996 Purchase Plan permits eligible employees to purchase common stock through payroll deductions, subject to certain limitations. The price at which stock is purchased under the 1996 Purchase Plan is equal to 85% of the fair market value of the common stock on the first day of the applicable offering period or the last day of the applicable offering period, whichever is lower. F-25 96 REPORT OF ERNST & YOUNG LLP, INDEPENDENT AUDITORS Board of Directors BioTek Solutions, Inc. We have audited the accompanying balance sheets of BioTek Solutions, Inc., as of June 30, 1995 and December 31, 1995, and the related statements of operations, changes in stockholders' equity (deficit), and cash flows for the year ended June 30, 1995 and the six-months ended December 31, 1995. These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on these financial statements based on our audits. We conducted our audits in accordance with generally accepted auditing standards. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion. In our opinion, the financial statements referred to above present fairly, in all material respects, the financial position of BioTek Solutions, Inc. as of June 30, 1995 and December 31, 1995, and the results of its operations and its cash flows for the year ended June 30, 1995 and the six-months ended December 31, 1995, in conformity with generally accepted accounting principles. Tucson, Arizona February 2, 1996, except for Note 12, as to which the date is February 20, 1996 F-26 97 BIOTEK SOLUTIONS, INC. BALANCE SHEETS (IN THOUSANDS, EXCEPT SHARE DATA) ASSETS (Note 8)
JUNE 30, DECEMBER 1995 31, 1995 -------- ----------- Current assets: Cash............................................................... $ 275 $ 31 Accounts receivable, net of allowance of $50 at June 30, 1995 and $78 at December 31, 1995........................................ 425 523 Inventories (Note 4)............................................... 152 168 Prepaid expenses................................................... 115 607 -------- -------- Total current assets....................................... 967 1,329 Property and equipment, net (Note 5)................................. 940 795 Other assets (Note 6)................................................ 581 470 -------- -------- $ 2,488 $ 2,594 ======== ======== LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) Current liabilities: Accounts payable................................................... $ 1,443 $ 1,128 Accrued expenses (Note 7).......................................... 3,700 5,228 Current portion of long-term debt (Note 8)......................... 1,106 8,685 -------- -------- Total current liabilities.................................. 6,249 15,041 Long-term debt, less current portion (Note 8)........................ 8,971 2,080 Commitments and contingencies (Note 11) Stockholders' equity (deficit): Common stock, no par value: Authorized -- 10,000,000 shares Outstanding -- 8,593,915 and 9,024,195 shares at June 30, 1995 and December 31, 1995, respectively............................ 3,047 3,051 Accumulated deficit................................................ (15,764) (17,563) Treasury stock..................................................... (15) (15) -------- -------- Total stockholders' equity (deficit)....................... (12,732) (14,527) -------- -------- $ 2,488 $ 2,594 ======== ========
See accompanying notes. F-27 98 BIOTEK SOLUTIONS, INC. STATEMENTS OF OPERATIONS (IN THOUSANDS)
SIX-MONTHS YEAR ENDED ENDED JUNE 30, DECEMBER 31, 1995 1995 ---------- ------------ Revenues............................................................ $ 6,043 $ 3,640 Cost of sales....................................................... 3,714 2,233 ------- ------- 2,329 1,407 Cost and expenses: Research and development.......................................... 1,734 751 Selling, general and administrative expenses...................... 3,666 1,327 ------- ------- Loss from operations................................................ (3,071) (671) Interest expense.................................................... 1,730 979 Amortization and other.............................................. 298 149 ------- ------- Net loss............................................................ $ (5,099) $ (1,799) ======= =======
See accompanying notes. F-28 99 BIOTEK SOLUTIONS, INC. STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (DEFICIT) (IN THOUSANDS, EXCEPT SHARE DATA)
COMMON STOCK ---------------------- SHARES ACCUMULATED TREASURY OUTSTANDING AMOUNT DEFICIT STOCK TOTAL ----------- ------ ----------- -------- -------- Balance, July 1, 1994................. 7,478,985 $2,335 $ (9,920) $ -- $ (7,585) Net loss............................ -- -- (5,099) -- (5,099) Issuance of common stock with debt............................. 1,082,964 694 -- -- 694 Repurchase of founder's shares with note............................. (950,000) -- (745) (15) (760) Shares issued as compensation for financings....................... 574,770 6 -- -- 6 Exercise of warrants................ 407,196 12 -- -- 12 --------- ------ -------- ---- -------- Balance, June 30, 1995................ 8,593,915 3,047 (15,764) (15) (12,732) Net loss............................ -- -- (1,799) -- (1,799) Exercise of warrants................ 430,280 4 -- -- 4 --------- ------ -------- ---- -------- Balance, December 31, 1995............ 9,024,195 $3,051 $ (17,563) $(15) $(14,527) ========= ====== ======== ==== ========
See accompanying notes. F-29 100 BIOTEK SOLUTIONS, INC. STATEMENTS OF CASH FLOWS (IN THOUSANDS)
SIX-MONTHS YEAR ENDED ENDED JUNE 30, DECEMBER 31, 1995 1995 ---------- ------------ CASH FLOWS FROM OPERATING ACTIVITIES Net loss............................................................ $ (5,099) $ (1,799) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation and amortization..................................... 1,501 776 Changes in operating assets and liabilities: Accounts receivable............................................... (306) (98) Inventories....................................................... 379 (16) Other assets...................................................... (152) (15) Accounts payable.................................................. (233) (834) Other liabilities................................................. 571 781 ---------- ------------ Net cash used in operating activities............................... (3,339) (1,205) CASH FLOWS FROM INVESTING ACTIVITIES Purchases of property and equipment................................. (84) -- ---------- ------------ Net cash used in investing activities............................... (84) -- CASH FLOWS FROM FINANCING ACTIVITIES Issuance of common stock............................................ 18 4 Issuance of notes payable, net of loan origination fees............. 3,418 957 ---------- ------------ Net cash provided by financing activities........................... 3,436 961 ---------- ------------ Net increase (decrease) in cash..................................... 13 (244) Cash, beginning of period........................................... 262 275 ---------- ------------ Cash, end of period................................................. $ 275 $ 31 ======== ========== SUPPLEMENTAL CASH FLOW INFORMATION Cash paid for interest.............................................. $ 351 $ 69 ======== ==========
See accompanying notes. F-30 101 BIOTEK SOLUTIONS, INC. NOTES TO FINANCIAL STATEMENTS DECEMBER 31, 1995 1. BACKGROUND BioTek Solutions, Inc. (the Company) develops, manufactures, markets and supports proprietary computerized instruments that automate biopsy tests for the diagnosis of cancer, viruses and other conditions and diseases. These instruments use the Company's chemical reagents and utilize monoclonal antibodies, DNA probes and other sophisticated analytical techniques. This system effectively replaces the labor-intensive, manually-performed sequences of immunohistochemistry analysis of the biopsy, and allows the user to perform up to five test routines simultaneously with increased accuracy and significant cost reduction. The Company also provides extensive after-sale support and maintenance. 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Revenue: Revenue generally is recognized upon shipment of products. Revenue from service contracts is recognized ratably over the lives of the contracts. Credit Risk: Virtually all of the Company's sales are made through two distributors. The Company has not experienced bad debts from these distributors in the past. The domestic distribution agreement expires in April 1998, and the international distribution agreement expires in December 1999, if not renewed by the parties. A portion of the cash flows from these distribution agreements have been pledged to repay the advances from one of the distributors and to reimburse contract manufacturers for start-up expenses (see Note 7). Inventories: Inventories are stated at the lower of cost (first-in, first-out method) or market. Property and Equipment: Property and equipment are stated at cost. The Company capitalizes expenditures that materially increase asset lives and charges ordinary repairs and maintenance to operations as incurred. Depreciation and amortization are provided using the straight-line method over the estimated useful lives of the assets, which are generally three to five years. Income Taxes: The Company accounts for income taxes using the liability method. Deferred tax assets and liabilities are determined based on differences between financial reporting and tax bases of assets and liabilities and are measured using enacted tax rates and laws expected to be in effect when the differences are expected to reverse. Valuation allowances are established when necessary to reduce the carrying amount of deferred tax assets to their net realizable value. Stock-Based Compensation: The Company accounts for its stock compensation arrangements under the provisions of APB 25, Accounting for Stock Issued to Employees, and intends to continue to do so. Use of Estimates: The preparation of financial statements in accordance with generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. 3. FAIR VALUE OF FINANCIAL INSTRUMENTS The Company's cash, accounts receivable, and long-term debt represent financial instruments as defined by Statement of Financial Accounting Standards No. 107, Disclosures About Fair Value of Financial Instruments. The carrying value of these financial instruments is a reasonable approximation of fair value. F-31 102 BIOTEK SOLUTIONS, INC. NOTES TO FINANCIAL STATEMENTS (CONTINUED) 4. INVENTORIES Inventories consist of the following:
JUNE 30, DECEMBER 31, 1995 1995 -------- ------------ (IN THOUSANDS) Raw materials and work-in-process...................... $100 $102 Finished goods......................................... 52 66 ---- ---- $152 $168 ==== ====
5. PROPERTY AND EQUIPMENT Property and equipment consist of the following:
JUNE 30, DECEMBER 31, 1995 1995 --------- ------------- (IN THOUSANDS) Machinery and equipment............................... $ 1,311 $ 1,312 Furniture and fixtures................................ 31 31 Leasehold improvements................................ 135 135 Other................................................. 22 18 ------ ------ 1,499 1,496 Less accumulated depreciation and amortization........ 559 701 ------ ------ $ 940 $ 795 ====== ======
6. OTHER ASSETS Other assets consist of the following:
JUNE 30, DECEMBER 31, 1995 1995 --------- ------------- (IN THOUSANDS) Patents, net.......................................... $ 148 $ 167 Loan origination fees, net............................ 417 282 Deposits and other.................................... 16 21 ---- ---- $ 581 $ 470 ==== ====
Patents are net of amortization of $14,000 and $19,000 at June 30, 1995 and December 31, 1995, respectively. Loan origination fees are net of amortization of $512,000 and $647,000 at June 30, 1995 and December 31, 1995, respectively. Loan origination fees were paid to a broker/dealer controlled by a member of the Company's Board of Directors in connection with private placement offerings. These fees include a commission of 10% of the funds raised from investors not identified by the Company and 5% for investors identified by the Company, as well as five-year warrants to buy common stock equal to 10% of common stock issued for investors not identified by the Company and 6% for investors identified by the Company. These fees are included in other assets in the accompanying balance sheets and are being amortized over the terms of the related notes payable. F-32 103 BIOTEK SOLUTIONS, INC. NOTES TO FINANCIAL STATEMENTS (CONTINUED) 7. ACCRUED EXPENSES Accrued expenses consist of the following:
JUNE 30, DECEMBER 31, 1995 1995 --------- ------------- (IN THOUSANDS) Advances from distributor............................. $ 1,402 $ 2,239 Legal fees and settlements............................ 868 1,124 Accrued interest...................................... 380 676 Deferred revenue...................................... 341 455 Reimbursement of start-up expenses to contract manufacturers....................................... 230 242 Due to officers....................................... 210 227 Other................................................. 269 265 ------ ------ $ 3,700 $ 5,228 ====== ======
8. LONG-TERM DEBT Long-term debt, consists of the following:
JUNE 30, DECEMBER 31, 1995 1995 --------- ------------- (IN THOUSANDS) Notes payable issued through private placements: 7.5% due July 31, 1995, extended (see below)........ $ 1,500 $ 1,500 7.5% due December 31, 1996.......................... 1,146 1,087 7.5% due March 31, 1996............................. 500 500 7.5% due June 30, 1996.............................. 600 600 8.25% due September 30, 1996........................ 5,869 5,869 Zero coupon, due September 30, 1997................. 1,113 1,334 Other................................................. 881 877 ------ ------ 11,609 11,767 Less: Original issue discount............................. 1,532 1,002 Current portion..................................... 1,106 8,685 ------ ------ $ 8,971 $ 2,080 ====== ======
Substantially all of the Company's financing has consisted of financing units. Each unit consists of a note payable with a fixed interest rate and a specified number of shares of the Company's common stock. The value of the common stock has been recorded as imputed interest on the notes payable, and is being amortized as additional interest expense over the life of the notes. This discount increases the interest rates on the notes from stated rates of between 7.5% and 8.25% to effective rates of between 7.8% and 31.6%. Annual maturities of the Company's long-term debt are $8,685,000 in 1996 and $2,080,000 in 1997. During the fiscal year ended June 30, 1995, investors holding notes with a face value of $966,000 and accrued interest of $180,000 due December 31, 1994 exchanged these notes for new notes with a face value of $1,146,000 due December 31, 1996 with interest payable quarterly at 7.5%. In accordance with the terms of the offering document, the Company extended the maturity of the notes originally due July 31, 1995 until October 31, 1995. Under the terms of the offering document, holders of F-33 104 BIOTEK SOLUTIONS, INC. NOTES TO FINANCIAL STATEMENTS (CONTINUED) these notes must proceed against the Company as a group (defined as holders of at least 50% of the total principal balance) to declare the notes in default. The Company has obtained waivers from holders of greater than 50% of the outstanding principal balance, deferring any action against the Company until March 31, 1996. Notes with a face value of $1,113,000 and $1,334,000 at June 30, 1995 and December 31, 1995 are convertible into the Company's common stock at a conversion rate of one share of stock per $1.00 of note principal. All notes call for quarterly payments of interest. The notes may be called prior to maturity at the option of the Company. The Company may extend the maturity of the notes by three months upon notice. The notes are automatically due in full upon liquidation of the Company, sale of the Company, default or an initial public offering in excess of $5,000,000. The notes are collateralized by substantially all of the Company's assets. In connection with the business combination transaction (see Note 12), Ventana Medical Systems, Inc. ("Ventana") replaced substantially all of the above notes with Ventana exchange notes ("Exchange Notes"). The Exchange Notes are payable at the earlier of 30 days after a successful public offering of Ventana stock or February 1998. The Exchange Notes bear interest at 7%, payable December 31, 1996 and 1997. The interest due December 31, 1996 is payable either in cash or Ventana common stock, at Ventana's option. If the notes are redeemed prior to December 31, 1996, no interest is payable. The Exchange Notes are convertible into Ventana common stock at a price of $5.00 per share for 30 days subsequent to the closing of the transaction. 9. STOCKHOLDERS' EQUITY (DEFICIT) In January 1994, the Board of Directors adopted the Amended and Restated 1991 Stock Incentive Plan (the Plan). The Plan provides for the granting of options to purchase common stock that are either intended to qualify as incentive common stock options or nonqualified options. All officers, directors, employees, consultants, advisers, independent contractors and agents are eligible to receive options under the Plan, except that only employees may receive incentive common stock options. The maximum number of common shares available for issuance under the Plan is 1,250,000. The exercise price of incentive common stock options granted under the Plan must be at least equal to the fair market value of the shares on the date of grant (110% of fair market value in the case of participants who own shares possessing more than 10% of the combined voting power of the Company) and may not have a term in excess of ten years from the date of grant (five years in the case of participants who own shares possessing more than 10% of the combined voting power of the Company). A summary of changes in the common shares under option follows:
SHARES PRICE UNDER OPTION RANGE ------------ ------------- Balance, July 1, 1994............................ 818,000 $.45 -- $3.00 Granted........................................ 8,000 2.50 Canceled....................................... (119,419) .45 -- 2.50 ------------ ------------- Balance, June 30, 1995........................... 706,581 .45 -- 3.00 Granted........................................ -- -- Canceled....................................... -- -- ------------ ------------- Balance, December 31, 1995....................... 706,581 $.45 -- $3.00 ========== ============
In January 1996, the Company's Board of Directors terminated the Plan pursuant to the Plan document. Upon termination, all options became fully vested. All options not exercised within 30 days of the termination are canceled. F-34 105 BIOTEK SOLUTIONS, INC. NOTES TO FINANCIAL STATEMENTS (CONTINUED) Warrants for the purchase of 1,248,917 shares of common stock with exercise prices between $.01-$3.33 were outstanding at December 31, 1995. All warrants will be canceled upon closing of the Ventana acquisition (see Note 12). 10. INCOME TAXES The Company's deferred tax assets consist of the following:
JUNE 30, 1995 DECEMBER 31, 1995 ------------------- ------------------- NON- NON- CURRENT CURRENT CURRENT CURRENT ------- ------- ------- ------- (IN THOUSANDS) Net operating loss carryforwards...... $ -- $ 3,954 $ -- $ 4,331 Capitalized research and development......................... -- 1,025 -- 1,133 Research and development credits...... -- 76 -- 113 Basis of fixed assets................. -- 82 -- 110 Reserves and allowances not currently deductible.......................... 355 -- 332 -- ----- ------- ----- ------- 355 5,137 332 5,687 Valuation allowance................... (355) (5,137) (332) (5,687) ----- ------- ----- ------- Net deferred tax assets............... $ -- $ -- $ -- $ -- ===== ======= ===== =======
Temporary differences between the federal net operating losses for financial reporting and income tax purposes primarily relate to the deferral of research and development expenses for tax purposes. At June 30, 1995 and December 31, 1995, the Company had net operating loss carryforwards for federal and state purposes of $9,884,000 and $10,828,000, respectively. These federal and state carryforwards will begin to expire in 2008, if not previously utilized. Utilization of the Company's net operating loss carryforwards will be subject to limitations due to the change in ownership provisions of the Internal Revenue Code as a result of the acquisition by Ventana (see Note 12). These carryforwards, therefore, may expire prior to being fully utilized. 11. COMMITMENTS AND CONTINGENCIES The Company leases its operating facility under an operating lease. The Company has the following future minimum annual lease payments as of December 31, 1995:
(IN THOUSANDS) -------------- 1996........................... $147 1997........................... 113 1998........................... 66 ---- $326 ====
Total rent expense related to these facility leases was approximately $195,000 for the year ended June 30, 1995 and $110,000 for the six-months ended December 31, 1995. A competitor has filed suit against the Company alleging infringement of certain patent rights. The Company is involved in various other litigation arising in the normal course of business. Management, in conjunction with outside counsel, periodically reviews such matters and makes any accruals deemed necessary. Management is of the opinion that the disposition of these claims will not have a material effect on the Company's financial statements. F-35 106 BIOTEK SOLUTIONS, INC. NOTES TO FINANCIAL STATEMENTS (CONTINUED) 12. SUBSEQUENT EVENT On February 20, 1996, the Company's stockholders approved the acquisition of all of the Company's outstanding common stock by Ventana for consideration of $18,763,000. The purchase price includes cash, issuance of Exchange Notes, and the assumption of liabilities. The Company does not anticipate any funds will remain for common stockholders once the Company's liabilities are settled. The Company will become a wholly owned subsidiary of Ventana, which will provide the financial resources for the Company to meet its operating needs. The Company incurred $1,395,000 in costs subsequent to year end related to the transaction, including the issuance of notes payable of $888,000 and the payment of cash of $328,000 paid to officers and directors of the Company. Subsequent to December 31, 1995, the Company renegotiated certain obligations with its vendors. Accounts payable, accrued expenses, and long-term debt with carrying values totaling $1,923,000 in the accompanying balance sheet were settled for $1,120,000. The resulting gain of $803,000 is not included in the accompanying statement of operations. F-36 107 REPORT OF INDEPENDENT PUBLIC ACCOUNTANTS To the Board of Directors of BioTek Solutions, Inc. We have audited the accompanying balance sheets of BIOTEK SOLUTIONS, INC.(a California corporation) as of June 30, 1993 and 1994 and the related statements of operations, shareholders' deficit and cash flows for the years then ended June 30, 1993 and 1994. These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on these financial statements based on our audits. We conducted our audits in accordance with generally accepted auditing standards. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion. In our opinion, the financial statements referred to above present fairly, in all material respects, the financial position of BioTek Solutions, Inc. as of June 30, 1993 and 1994, and the results of its operations and its cash flows for the years then ended in conformity with generally accepted accounting principles. ARTHUR ANDERSEN LLP Los Angeles, California February 2, 1996 (except with respect to the information in Note 8 as to which the date is February 20, 1996) F-37 108 BIOTEK SOLUTIONS, INC. BALANCE SHEETS AS OF JUNE 30, 1993 AND 1994 ASSETS
1993 1994 ---------- ---------- Current Assets: Cash.............................................................. $ 100,519 $ 261,611 Accounts receivable, net of allowance of $41,650 and $44,984 at June 30, 1993 and 1994, respectively........................... 246,115 421,269 Inventories....................................................... 332,038 530,926 Prepaid expenses.................................................. -- 26,466 ---------- ---------- Total current assets...................................... 678,672 1,240,272 ---------- ---------- Property, Equipment and Leasehold Improvements: Equipment......................................................... 370,700 1,071,004 Furniture and fixtures............................................ 10,293 31,095 Leasehold improvements............................................ 30,754 130,841 Vehicles.......................................................... 5,000 5,000 Computer hardware and software.................................... 55,776 184,988 ---------- ---------- 472,523 1,422,928 Less -- Accumulated depreciation and amortization................. 55,076 279,139 ---------- ---------- 417,447 1,143,789 ---------- ---------- Other Assets: Patents, net of amortization of $1,929 and $6,543 at June 30, 1993 and 1994, respectively......................................... 59,957 90,319 Private placement origination fee, net of amortization of $51,816 and $168,897 at June 30, 1993 and 1994, respectively........... 206,684 464,816 Deposits.......................................................... 670 18,577 ---------- ---------- 267,311 573,712 ---------- ---------- $1,363,430 $2,957,773 ========== ========== LIABILITIES AND STOCKHOLDERS' DEFICIT Current Liabilities: Accounts payable.................................................. $ 677,456 $1,862,903 Accrued liabilities............................................... 729,375 695,726 Other............................................................. 136,280 359,139 Restructuring reserve............................................. -- 611,441 Current portion of notes payable.................................. -- 979,000 Reimbursement of start-up expenses to contract manufacturer....... -- 662,000 ---------- ---------- Total current liabilities................................. 1,543,111 5,170,209 ---------- ---------- Notes Payable, net of current portion and original issue discount... 3,144,099 5,372,823 ---------- ---------- Commitments and Contingencies (Note 4) Stockholders' Deficit: Common stock, no par value Authorized -- 10,000,000 shares issued and outstanding 5,940,800 and 7,478,985 in 1993 and 1994 respectively.......... 743,646 2,335,031 Accumulated deficit............................................... (4,067,426) (9,920,290) ---------- ---------- (3,323,780) (7,585,259) ---------- ---------- $1,363,430 $2,957,773 ========== ==========
The accompanying notes are an integral part of these financial statements. F-38 109 BIOTEK SOLUTIONS, INC. STATEMENTS OF OPERATIONS FOR THE YEARS ENDED JUNE 30, 1993 AND 1994
1993 1994 ----------- ----------- Revenues............................................................ $ 1,549,655 $ 6,159,843 ----------- ----------- Cost and expenses: Cost of revenues.................................................. 1,410,693 4,103,279 Research and development.......................................... 1,370,376 861,310 Selling, general and administrative expenses...................... 1,764,228 5,222,464 Restructuring expense............................................. -- 877,004 ----------- ----------- 4,545,297 11,064,057 ----------- ----------- Loss from operations........................................... (2,995,642) (4,904,214) ----------- ----------- Interest expense (income), net: Interest expense.................................................. 255,406 953,691 Interest income................................................... (7,722) (5,841) ----------- ----------- 247,684 947,850 ----------- ----------- Loss before provision for state income taxes................... (3,243,326) (5,852,064) Provision for state income taxes.................................... 1,000 800 ----------- ----------- Net loss............................................................ $(3,244,326) $(5,852,864) =========== ===========
The accompanying notes are an integral part of these financial statements. F-39 110 BIOTEK SOLUTIONS, INC. STATEMENTS OF STOCKHOLDERS' DEFICIT FOR THE YEARS ENDED JUNE 30, 1993 AND 1994
COMMON STOCK -------------------------- SHARES ACCUMULATED OUTSTANDING AMOUNT DEFICIT ----------- ---------- ----------- Balance, June 30, 1992................................ 3,945,000 $ 54,568 $ (823,100) Issuance of Common Stock in connection with private placement........................................ 229,800 2,298 -- Issuance of Common Stock in settlement of lawsuits in connection with bridge loan................... 50,000 500 -- Issuance of Common Stock in connection with the first private placement with a related party..... 900,000 9,000 -- Issuance of Common Stock in connection with the second private placement with a related party.... 250,000 207,500 -- Issuance of Common Stock in settlement of lawsuit with former board member......................... 266,000 220,780 -- Issuance of Common Stock in connection with the third private placement with a related party..... 300,000 249,000 -- Net loss.............................................. -- (3,244,326) --------- ----------- ------------ Balance, June 30, 1993................................ 5,940,800 743,646 (4,067,426) Issuance of common stock upon the exercise of warrants......................................... 5,000 2,250 -- Issuance of common stock in connection with the fourth, fifth and sixth private placements with a related party.................................... 1,533,185 1,589,135 -- Net loss.............................................. -- -- (5,852,864) --------- ----------- ------------ Balance, June 30, 1994................................ 7,478,985 $2,335,031 $(9,920,290) ========= =========== ============
The accompanying notes are an integral part of these financial statements. F-40 111 BIOTEK SOLUTIONS, INC. STATEMENTS OF CASH FLOWS FOR THE YEARS ENDED JUNE 30, 1993 AND 1994
1993 1994 ----------- ----------- CASH FLOWS FROM OPERATING ACTIVITIES: Net loss........................................................ $(3,244,326) $(5,852,864) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation................................................. 51,626 228,677 Interest and amortization of loan fees....................... 94,993 552,912 Issuance of Common Stock for settlement of lawsuits.......... 221,280 -- Restructuring reserve........................................ -- 611,441 Reimbursement of start-up expenses to contract manufacturer................................................ -- 662,000 (Increase) decrease in: Accounts receivable.......................................... (245,115) (175,154) Inventories.................................................. (332,038) (198,888) Prepaid expenses............................................. 6,520 (26,466) Deposits..................................................... (48,989) (17,907) Patents...................................................... 2,660 (34,976) Increase (decrease) in: Accounts payable............................................. 659,940 1,185,447 Accrued liabilities.......................................... 706,427 (33,649) Other liabilities............................................ 91,280 222,859 ----------- ----------- Net cash used in operating activities................... (2,035,742) (2,876,568) ----------- ----------- CASH FLOWS FROM INVESTING ACTIVITIES: Purchase of property, equipment and leasehold improvements...... (376,149) (950,405) ----------- ----------- CASH FLOWS FROM FINANCING ACTIVITIES: Issuance of Common Stock........................................ -- 2,670 Issuance of notes payable....................................... 2,626,000 4,360,608 Loan fees paid in association with issuance of notes payable.... (258,500) (375,213) ----------- ----------- Net cash provided by financing activities............... 2,367,500 3,988,065 ----------- ----------- NET INCREASE (DECREASE) IN CASH................................... (44,391) 161,092 Cash, beginning of period......................................... 144,910 100,519 ----------- ----------- Cash, end of period............................................... $ 100,519 $ 261,611 =========== =========== Supplemental disclosures of cash flow information: Cash paid during the year for: Interest..................................................... $ 50,000 $ 272,211 =========== =========== Taxes........................................................ $ 1,000 $ 1,600 =========== ===========
The accompanying notes are an integral part of these financial statements. F-41 112 BIOTEK SOLUTIONS, INC. NOTES TO FINANCIAL STATEMENTS JUNE 30, 1994 1. SIGNIFICANT RISKS BUSINESS AND BASIS OF PRESENTATION BioTek Solutions, Inc. ("the Company") develops, manufactures, markets and supports proprietary computerized instruments that automate biopsy tests for the diagnosis of cancer, viruses and other conditions and diseases. These instruments use the Company's optimized chemical reagents and monoclonal antibodies. This system effectively replaces the labor-intensive, manually-performed sequences of the biopsy and surgical specimen preparation and allows the user to precisely and simultaneously perform up to five test routines with increased accuracy and significant cost reduction. The Company also provides extensive after-sale support and maintenance. The Company was formed in October 1990 and was a development stage company through June 30, 1992. The Company began selling products in the first quarter of fiscal 1993 and began volume sales in March 1993. The Company incurred net losses of $3,244,326 and $5,852,864 for the years ended June 30, 1993 and 1994, respectively. Continuing losses have adversely affected the liquidity of the Company. As of June 30, 1994, the Company had a working capital deficit of $3,929,937. The Company has relied upon private sales of equity and debt securities to obtain necessary working capital to support its activities. On February 20, 1996, the Company's stockholders approved the acquisition of the Company by Ventana Medical Systems, Inc. (Ventana)(see Note 8). RESTRUCTURING CHARGES During fiscal 1994, the Company recorded a $877,004 charge to income for the repositioning of the Company's operations. The repositioning was necessitated by plans of a new management team. The charge includes costs associated with reductions in work force, removal of former president and termination of various leases. The Company believes that the repositioning and resulting expense reductions will allow it to operate in a more efficient manner in the future. 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES REVENUE RECOGNITION Revenue is recognized upon shipment of product. Revenue for the years ended June 30, 1993 and 1994 were comprised of the following:
1993 1994 ---------- ---------- Instruments......................................... $ 938,896 $3,519,723 Chemistries, disposables, service and other......... 610,759 2,640,120 ---------- ---------- $1,549,655 $6,159,843 ========== ==========
In January 1993, the Company signed an exclusive distribution agreement with Curtin Matheson Scientific, Inc. (CMS). This gave CMS the exclusive rights to sell instruments and consumables in the United States. Total sales to CMS for the years ended June 30, 1993 and 1994 were $1,213,000 and $5,445,394, respectively. CREDIT RISK Virtually all of the Company's sales are made through two distributors. The Company has not experienced bad debts from these distributors in the past. The distribution agreement with CMS expires in F-42 113 BIOTEK SOLUTIONS, INC. NOTES TO FINANCIAL STATEMENTS (CONTINUED) April 1998, and the international distribution agreement expires in December 1999, if not renewed by the parties. USE OF ESTIMATES The preparation of financial statements in accordance with generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. INVENTORY Inventory consists of automated instruments, chemical reagents, and replacement parts for the automated instruments (see Note 4). As of June 30, 1993 and 1994, inventory consisted of:
1993 1994 -------- -------- Raw materials.......................................... $219,633 $ 36,078 Work in process........................................ 71,729 114,328 Finished goods......................................... 40,676 380,520 -------- -------- $332,038 $530,926 ======== ========
Inventory is stated at the lower of cost (first-in, first-out) or market. DEPRECIATION AND AMORTIZATION Depreciation and amortization is provided through the use of the straight-line method over the estimated useful lives of the assets as follows:
ASSET TYPE USEFUL LIFE --------------------------------------- ------------------------- Equipment.............................. 5 years Furniture & Fixtures................... 5 years Leasehold Improvements................. Lesser of the asset life or the life of the respective lease Vehicles............................... 5 years Computer Hardware...................... 5 years Computer Software...................... 3 years
The Company capitalizes expenditures that materially increase asset lives and charges ordinary repairs and maintenance to operations as incurred. When assets are sold or otherwise disposed of, the cost and related accumulated depreciation and amortization are removed from the accounts and any gain or loss is included in results of operations. CAPITALIZED PATENT COSTS The Company capitalizes costs of obtaining patent rights for certain products. Amortization of capitalized patent cost is provided on a straight-line basis over 17 years. F-43 114 BIOTEK SOLUTIONS, INC. NOTES TO FINANCIAL STATEMENTS (CONTINUED) INCOME TAXES No provision was made for federal income tax purposes since the Company has recorded a net operating loss from inception. The primary difference between book and tax loss is the capitalization of research and development costs for tax purposes. At June 30, 1994, the Company had net operating losses for federal and state purposes of $6,754,000. These federal and state carryforwards will begin to expire in 2006, if not previously utilized. Utilization of the Company's net operating losses will be subject to limitations due to the change in ownership provisions of the Internal Revenue Code as a result of the acquisition by Ventana (see Note 8). These carryforwards, therefore, may expire prior to being fully utilized. 3. CAPITAL TRANSACTIONS On September 20, 1993, the shareholders approved an increase in the number of authorized shares of common stock from 6,500,000 to 10,000,000. In November 1990, the Company issued 1,000,000 shares of Common Stock to each of its three founders in exchange for $45,118. In addition, two of the founders transferred all their rights, title and interest in certain technology and equipment which was valued at zero. In July 1992, the Company issued 25,000 shares to each of two investors and a $24,000 note due December 31, 1992 with no interest. The note and shares were issued as part of a settlement agreement and mutual release among the investors, the Company and an officer of the Company. Between January 1992 and September 1992, the Company sold $979,000 in aggregate principal amount of units in a private placement to various investors. Each unit consisted of 30,000 shares of Common Stock and a senior secured note in the principal amount of $25,000 with interest accruing at 7.5 percent until maturity on July 31, 1995. Danzi Capital Group (DANZI) served as private placement agent for the offering (see Note 6). The Common Stock was valued at $.01 per share. In September 1992, the Company sold $1,500,000 in aggregate principal amount of units in a private placement to various investors. Each unit consisted of 15,000 shares of Common Stock and a senior unsecured note in the principal amount of $25,000 with interest accruing at 7.5 percent until maturity on July 31, 1995. Danzi served as private placement agent for the offering (see Note 6). The Common stock was valued at $.01 per share. In March 1993, the Company issued 266,000 shares to two former board members. These shares were issued as part of settlement agreements and a mutual release among the former board members and the Company. In April 1993, the Company sold $500,000 in aggregate principal amount of units in a private placement to various investors. Each unit consisted of 12,500 shares of Common Stock and a senior unsecured note in the principal amount of $25,000 with interest accruing at 7.5 percent until maturity on March 31, 1996. Danzi served as private placement agent for the offering (see Note 6). The Common stock was valued at $.83 per share. In May 1993, the Company sold $600,000 in aggregate principal amount of units in a private placement to various investors. Each unit consisted of 12,500 shares of Common Stock and a senior unsecured note in the principal amount of $25,000 with interest accruing at 7.5 percent until maturity on June 30, 1996. Danzi served as private placement agent for the offering (see Note 6). The Common Stock was valued at $.83 per share. Between July 1993 to October 1993, the Company sold $2,250,000 in aggregate principal amount of units in a private placement to various investors. Each unit consisted of 10,000 shares of Common Stock and a senior unsecured note in the principal amount of $25,000 with interest accruing at 8.25 percent until maturity F-44 115 BIOTEK SOLUTIONS, INC. NOTES TO FINANCIAL STATEMENTS (CONTINUED) on September 30, 1996. Danzi served as private placement agent for the offering (see Note 6). The Common Stock was valued at $.83 per share. Between March 1994 to June 1994, the Company sold $2,110,608 in aggregate principal amount of units in a private placement to various investors. Each unit consisted of 7,500 shares of Common Stock and a senior unsecured note in the principal amount of $25,000 with interest accruing at 8.25 percent until maturity on September 30, 1996. Danzi served as private placement agent for the offering (see Note 6). The Common Stock was valued at $1.33 per share. The value of the common stock has been recorded as imputed interest on the notes payable, and is being amortized as additional interest expense over the life of the notes. This discount increases the interest rates on the notes from stated rates of between 7.5 percent and 8.25 percent to effective rates of between 7.8 percent and 31.6 percent. 4. COMMITMENTS AND CONTINGENCIES ROYALTIES In May 1993, the Company entered into a royalty agreement with a slide manufacturer that obligates the Company to pay a percentage of the sales of certain items to the manufacturer based on terms defined in the royalty agreement with a guaranteed minimum of $50,000 per year for 4 years beginning in fiscal 1994. There was royalty expense of $50,000 for the year ended June 30, 1994 and no royalty expense for the year ended June 30, 1993. LEASES The Company leased its office facility during 1992 under an operating lease on a month to month basis. The Company also has four sales offices that are rented on a month to month basis. Total rental expense related to these facility leases was approximately $106,000 and $140,175 for the years ended June 30, 1993 and 1994, respectively. The future minimum annual lease payments under a new 5 year office lease agreement signed subsequent to year end is as follows:
YEAR ENDED JUNE 30, - ------------------------------ 1995.................... $112,794 1996.................... 112,794 1997.................... 112,794 1998.................... 112,794 $451,176
DISTRIBUTOR LICENSING AGREEMENT In January 1993, the Company entered into a 5 year exclusive distribution agreement with CMS, a major distributor of medical products, to purchase and promote the Company's products. As of June 30, 1994, CMS had purchased 104 TechMate(TM) systems. CMS is required to purchase a total of 300 units by April 1995 in order to retain its exclusive distribution rights. CMS has not met this obligation; however no action has been taken. STOCK PURCHASE AGREEMENT On February 14, 1992, the Company entered into a buy/sell agreement (the "Buy-Sell Agreement") with the three founders of the Company. Under the agreement, if a founder should be terminated for cause or voluntarily resign without written approval of the board, then the other founders and the Company shall have the option, but not the obligation, at any time and from time to time to purchase all or any portion of the F-45 116 BIOTEK SOLUTIONS, INC. NOTES TO FINANCIAL STATEMENTS (CONTINUED) shares owned by such founder. If the termination is determined to be without cause, then such founder shall have the right to require the Company to purchase all or a portion of the shares owned by-the-founder subject to certain limitations as defined in the agreement. The purchase price will be at fair market value determined on a semi-annual basis by the founders. If the fair market value is not adjusted the last agreed upon rate will prevail. The last established fair market value as set by the founders was $0.80 per share. LITIGATION As of July 6, 1994, the former president of the Company was terminated. As a result of an arbitration ruling in July 1995, the Company has issued the former president a note for $760,000 bearing interest at 7.5 percent per year for the repurchase of his 950,000 shares. In March 1995, a competitor filed suit against the Company alleging infringement of certain patent rights. The Company is involved in various other actions arising in the normal course of business. Management, in conjunction with outside counsel, periodically reviews such matters and makes any accruals deemed necessary. Management is of the opinion that the disposition of these claims will not have a material effect on the Company's financial position or results of operations. 5. NOTES PAYABLE Notes payable, all issued in connection with private placements (see Notes 3 and 6), consisted of the following as of June 30, 1994: Secured Notes payable, collateralized by the assets of the Company, interest at 7.5 percent payable quarterly, due December 31, 1994, subsequently extended to December 31, 1996........................................................ $ 979,000 Secured Notes payable, collateralized by the assets of the Company, interest at 7.5 percent payable quarterly, due July 31, 1995, subsequently extended to October 31, 1996......... 1,500,000 Unsecured Notes payable, interest at 7.5 percent payable quarterly, due March 31, 1996............................... 500,000 Unsecured Notes payable, interest at 7.5 percent payable quarterly, due June 30, 1996................................ 600,000 Unsecured Notes payable, interest at 8.25 percent payable quarterly, due September 30, 1996........................... 4,360,608 ---------- 7,939,608 ---------- Less: Original issue discount........................................ 1,587,785 Current portion................................................ 979,000 ---------- $5,372,823 ==========
In connection with the sale of the Company to Ventana (see Note 8), the outstanding notes were exchanged for Ventana notes which are interest free if paid by December 31, 1996 and ultimately due with interest at 7 percent on December 31, 1997. The entire amount is due 30 days after completion of an initial public offering. 6. RELATED PARTIES The Company has completed several private placement offerings in which Danzi was the placement agent. In connection with these offerings Danzi was paid a commission of 10 percent of the funds raised from F-46 117 BIOTEK SOLUTIONS, INC. NOTES TO FINANCIAL STATEMENTS (CONTINUED) investors not identified by the Company and 5 percent for investors identified by the Company, payable upon the closing of the transactions. As additional consideration, the Company granted Danzi five-year warrants to buy Common Stock equal to 10 percent of Common Stock issued to investors not identified by the Company and 6 percent for identified obtained by the Company. Total fees paid and warrants issued to Danzi during the years ended June 30, 1993 and 1994 were $258,500, and 140,300 warrants in 1993 and $427,000 and 126,171 warrants in 1994. The fees paid to Danzi have been capitalized and are being amortized over the life of the related notes payable. The warrants issued to Danzi are summarized as follows:
EXPIRATION DATE EXERCISE PRICE UNDERLYING SHARES ------------------------------------------------------- -------------- ----------------- Between October 1997 and May 1998...................... $ 1.00 140,300 Between July 1998 and June 1999........................ $ 1.00 126,171 ------- 266,471 =======
7. STOCK OPTIONS In November 1991, the Company adopted the Biotek Solutions, Inc. 1991 Stock Incentive Plan (the "Plan"). In January 1994, the Board of Directors adopted the Amended and Restated 1991 Stock Incentive Plan, subject to shareholder approval. The Plan provides for the granting of options to purchase Common Stock that are either intended to qualify as incentive Common Stock options or non-qualified options. All officers, directors, employees, consultants, advisers, independent contractors and agents are eligible to receive options under the Plan, except that employees may only receive incentive Common Stock options. The maximum number of shares available for issuance under the Plan is 1,250,000. The exercise price of incentive Common Stock options granted under the Plan must be at least equal to the fair market value of the shares on the date of grant (110 percent of fair market value in the case of participants who own shares possessing more than 10 percent of the combined voting power of the Company) and may not have a term in excess of 10 years from the date of grant (five years in the case of participants who are more than 10 percent Common Stockholders). A summary of changes in the shares under option follows:
SHARES PRICE RANGE -------- ----------- Balance, June 30, 1992...................................... 430,750 $ 0.45 Granted................................................... 303,000 0.45-- 0.83 Canceled.................................................. -- -- ------- ----------- Balance, June 30, 1993...................................... 733,750 0.45-- 0.83 Granted................................................... 176,750 0.83-- 3.00 Canceled.................................................. 92,500 0.83-- 2.50 ------- ----------- Balance, June 30, 1994...................................... 818,000 $0.45--$3.00 ======= ===========
At June 30, 1993 expiration dates for options outstanding ranged from fiscal 2002 to 2003. No amounts have been reflected in the Company's statements of operations with respect to these stock options. In January 1996, the Company's Board of Directors terminated the plan, pursuant to the plan document. Upon termination, all options became fully vested. All options not exercised within 30 days of the termination are canceled. F-47 118 BIOTEK SOLUTIONS, INC. NOTES TO FINANCIAL STATEMENTS (CONTINUED) 8. SUBSEQUENT EVENTS On February 20, 1996, the Company's stockholders approved the acquisition of the Company by Ventana. Under the terms of the acquisition agreement, Ventana will pay $4.5 million in cash and notes and assume $12.5 million of the Company's liabilities. Substantially all of the proceeds to the Company will be used to retire existing liabilities. The Company does not anticipate any funds will remain for common stockholders once the Company's liabilities are settled. Subsequent to December 31, 1995, the Company renegotiated certain obligations with its vendors. Accounts payable, accrued expenses, and long-term debt with carrying values totaling $1,923,000 in the accompanying balance sheet were settled for $1,120,000. The resulting gain of $803,000 is not included in the accompanying statements of operations. F-48 119 - ------------------------------------------------------ - ------------------------------------------------------ NO DEALER, SALESMAN OR OTHER PERSON HAS BEEN AUTHORIZED TO GIVE ANY INFORMATION OR TO MAKE ANY REPRESENTATION NOT CONTAINED IN THIS PROSPECTUS, AND, IF GIVEN OR MADE, SUCH INFORMATION OR REPRESENTATION MUST NOT BE RELIED UPON AS HAVING BEEN AUTHORIZED BY THE COMPANY, ANY SELLING STOCKHOLDER, ANY UNDERWRITER OR ANY OTHER PERSON. THIS PROSPECTUS DOES NOT CONSTITUTE AN OFFER TO SELL, OR A SOLICITATION OF AN OFFER TO BUY, ANY SECURITIES OTHER THAN THE SECURITIES TO WHICH IT RELATES OR AN OFFER TO SELL, OR A SOLICITATION OF AN OFFER TO BUY, TO ANY PERSON IN ANY JURISDICTION IN WHICH SUCH AN OFFER OR SOLICITATION IS NOT AUTHORIZED, OR IN WHICH THE PERSON MAKING SUCH OFFER OR SOLICITATION IS NOT QUALIFIED TO DO SO, OR TO ANY PERSON TO WHOM IT IS UNLAWFUL TO MAKE SUCH OFFER OR SOLICITATION. NEITHER THE DELIVERY OF THIS PROSPECTUS NOR ANY SALE MADE HEREUNDER SHALL, UNDER ANY CIRCUMSTANCES, CREATE ANY IMPLICATION THAT THERE HAS BEEN NO CHANGE IN THE AFFAIRS OF THE COMPANY SINCE THE DATE HEREOF OR THAT THE INFORMATION CONTAINED HEREIN IS CORRECT AS OF ANY TIME SUBSEQUENT TO THE DATE HEREOF. ------------------ TABLE OF CONTENTS
PAGE ---- Prospectus Summary...................... 3 Risk Factors............................ 6 The Company............................. 15 Use of Proceeds......................... 15 Dividend Policy......................... 15 Dilution................................ 16 Capitalization.......................... 17 Selected Consolidated Financial and Operating Data........................ 18 Management's Discussion and Analysis of Financial Condition and Results of Operations............................ 20 Business................................ 33 Management.............................. 50 Certain Transactions.................... 57 Principal and Selling Stockholders...... 60 Description of Capital Stock............ 64 Shares Eligible for Future Sale......... 65 Underwriting............................ 67 Legal Matters........................... 68 Experts................................. 68 Additional Information.................. 68 Index to Consolidated Financial Statements............................ F-1
------------------ UNTIL , 1996 (25 DAYS AFTER THE DATE OF THIS PROSPECTUS) ALL DEALERS EFFECTING TRANSACTIONS IN THE REGISTERED SECURITIES, WHETHER OR NOT PARTICIPATING IN THIS DISTRIBUTION, MAY BE REQUIRED TO DELIVER A PROSPECTUS. THIS IS IN ADDITION TO THE OBLIGATION OF DEALERS TO DELIVER A PROSPECTUS WHEN ACTING AS UNDERWRITERS AND WITH RESPECT TO THEIR UNSOLD ALLOTMENTS OR SUBSCRIPTIONS. - ------------------------------------------------------ - ------------------------------------------------------ - ------------------------------------------------------ - ------------------------------------------------------ SHARES LOGO VENTANA MEDICAL SYSTEMS, INC. COMMON STOCK ----------------------- PROSPECTUS ----------------------- BEAR, STEARNS & CO. INC. DILLON, READ & CO. INC. , 1996 - ------------------------------------------------------ - ------------------------------------------------------ 120 VENTANA MEDICAL SYSTEMS, INC. APPENDIX -- GRAPHIC IMAGES INSIDE FRONT COVER (1) [Image: The Ventana ES System, an automated diagnostic instrument used to perform standardized IHC testing in clinical and research laboratories.] (2) [Image: The Ventana gen II, an automated diagnostic used to perform ISH (in situ hybridization) testing in clinical and research laboratories.] BACK INSIDE COVER (3) [The BioTek TechMate 500 System, a semi-automated diagnostic instrument used to perform standardized IHC testing in clinical and research laboratories.] 121 PART II INFORMATION NOT REQUIRED IN PROSPECTUS ITEM 13. OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION The following table sets forth the costs and expenses, other than underwriting discounts and commissions, payable by the Registrant in connection with the sale of Common Stock being registered. All amounts are estimates except the SEC registration fee and the NASD filing fee. SEC registration fee.............................................. $ 19,035 NASD filing fee................................................... 6,020 Nasdaq National Market listing fee................................ 40,000 Printing and engraving costs...................................... 150,000 Legal fees and expenses........................................... 300,000 Accounting fees and expenses...................................... 200,000 Blue Sky fees and expenses........................................ 20,000 Transfer Agent and Registrar fees................................. 5,000 Directors and officers insurance coverage premiums................ 150,000 Miscellaneous expenses............................................ 34,945 -------- Total................................................... $925,000 ========
- --------------- * To be filed by amendment. ITEM 14. INDEMNIFICATION OF DIRECTORS AND OFFICERS Article 10 of the Registrant's Certificate of Incorporation provides for the indemnification of directors to the fullest extent permissible under Delaware law. Article VI of the Registrant's Bylaws provides for the indemnification of officers, directors, employees and agents of the corporation if such person acted in good faith and in a manner reasonably believed to be in and not opposed to the best interest of the corporation, and, with respect to any criminal action or proceeding the indemnified party had no reason to believe his conduct was unlawful. Section 145 of the Delaware General Corporation Law permits a corporation to include in its charter documents, and in agreements between the corporation and its directors and officers, provisions expanding the scope of indemnification beyond that specifically provided by the current law. The Registrant will enter into indemnification agreements with its directors and executive officers, and intends to enter into indemnification agreements with any new directors and executive officers in the future. ITEM 15. RECENT SALES OF UNREGISTERED SECURITIES Since January 1, 1993, the Registrant has issued and sold (without payment of any selling commission to any person) the following unregistered securities (all of which are presented without giving effect to the reverse stock split to be effected prior to the closing of the Offering): (1) From inception of the Company, the Registrant issued and sold 807,585 shares of Common Stock to employees, directors and consultants at prices ranging from $.09 to $.35, upon exercise of incentive stock options under the Registrant's 1988 Stock Option Plan, or as stock purchases in connection with their employment with or services to the Company. (2) From inception of the Company, the Registrant issued and sold 222,989 shares of preferred stock to employees at prices ranging from $.90 to $2.15 per share pursuant to the 1991 Employee Stock Purchase Plan in connection with their employment with the Company. II-1 122 (3) From March 25, 1993 to January 23, 1995, Registrant issued 4,747,119 shares of Series D Preferred Stock at a price of $2.15 per share and 124,270 warrants for the purchase of Series D Preferred Stock with an exercise price of $2.15 per share to a total of 38 investors. (4) In October 1994, Registrant issued to R. James Danehy, President, Chief Executive Officer and a director of the Company a stock option covering 800,000 shares of Common Stock at an exercise price of $0.31 per share. 219,891 shares subject to such option which had vested were cancelled by the Company in November 1995, and the Company allowed Mr. Danehy to purchase 219,891 shares of Common Stock at a purchase price of $0.31 per share through his self-directed IRA. (5) In August 1994 the Company provided to Mr. Danehy the opportunity to purchase $200,000 of Series D Preferred Stock at $2.15 per share and an additional share of Common Stock at $0.84 per share for each two shares of Series D Preferred Stock purchased. Pursuant to his right, Mr. Danehy purchased 93,023 shares of Series D Preferred Stock and 46,512 shares of Common Stock at $0.31 per share in January 1996. (6) In February 1996, the Company issued approximately $12 million in Exchange Notes in exchange for notes held by 199 holders of BioTek notes as consideration for the acquisition of BioTek Solutions, Inc. Such Exchange Notes were convertible into Common Stock at a conversion price of $5.00 per share. Between February 26, 1996 and May 14, 1996 the Company issued approximately $5.1 million of convertible subordinated debt together with warrants to purchase 2,378,898 shares of Series D Preferred Stock at an exercise price of $2.15 per share to 68 investors (i.e., certain current stockholders and officers and directors of the Company). (7) In January 1996, the Company issued 69,767 shares of Series D Preferred Stock to Bear, Stearns & Co. Inc. as partial consideration for services rendered in connection with the acquisition of BioTek. The sales of the above securities were deemed to be exempt from registration under the Securities Act in reliance on Section 4(2) of the Securities Act, or Regulation D promulgated thereunder, or Rule 701 promulgated under Section 3(b) of the Securities Act, as transactions by an issuer not involving a public offering or transactions pursuant to compensatory benefit plans and contracts relating to compensation as provided under such Rule 701. The recipients of securities in each such transaction represented their intention to acquire the securities for investment only and not with a view to or for sale in connection with any distribution thereof and appropriate legends were affixed to the share certificates and warrants issued in such transactions. All recipients had adequate access, through their relationships with the Company, to information about the Registrant. ITEM 16. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES (a) EXHIBITS
EXHIBIT NUMBER DESCRIPTION ----------- ------------------------------------------------------------------------- 1.1* Form of Underwriting Agreement.
3.1(i)(a)** Restated Certificate of Incorporation, as amended. 3.1(i)(b)* Form of Restated Certificate of Incorporation to be filed after the closing of the offering made under this Registration Statement. 3.1(ii)(a)** Bylaws. 3.1(ii)(b)* Form of Bylaws to be effective on or about the closing of the Offering made under this Registration Statement. 4.1* Specimen Common Stock Certificate. 5.1** Opinion of Wilson Sonsini Goodrich & Rosati, Professional Corporation. 10.1(a)+ DAKO Distribution Agreement dated September 27, 1994. 10.1(b)+ First Amendment to DAKO Distribution Agreement dated March 24, 1995. 10.1(c)+ Further amendments to First Amendment to DAKO Distribution Agreement dated March 24, 1995. 10.2(a)* Kollsman Secured Promissory Note dated December 4, 1994.
II-2 123
EXHIBIT NUMBER DESCRIPTION ----------- ------------------------------------------------------------------------- 10.2(b)* Development Secured Promissory Note dated March 24, 1995. 10.3+ Curtin Matheson Scientific, Inc. Distribution Agreement dated January 18, 1993. 10.4(a)** Restricted Stock Purchase Agreement with Jack W. Schuler dated April 19, 1996 -- Tranche 1 10.4(b)** Restricted Stock Purchase Agreement with Jack W. Schuler dated April 19, 1996 -- Tranche 2 10.4(c)** Restricted Stock Purchase Agreement with Jack W. Schuler dated April 19, 1996 -- Tranche 3 10.5(a)** Restricted Stock Purchase Agreement with John Patience dated April 19, 1996 -- Tranche 1 10.5(b)** Restricted Stock Purchase Agreement with John Patience dated April 19, 1996 -- Tranche 2 10.6* Form of Indemnification Agreement for directors and officers. 10.7(a)** 1988 Stock Option Plan and forms of agreements thereunder. 10.7(b)** 1996 Stock Option Plan and forms of agreements thereunder. 10.8(a)** 1991 Employee Stock Purchase Plan. 10.8(b)** 1996 Employee Stock Purchase Plan. 10.9** Questier Employment Agreement dated October 20, 1995. 10.10** Restated Investors Rights Agreement dated February 20, 1996. 10.11** Sublease of Premises between the Registrant and Jerry R. Jones & Associates, Inc., dated February 29, 1996, with attached Master Lease, dated October 26, 1988. 10.12** Master Lease Purchase Agreement between the Registrant and Copelco Leasing Corporation dated April 13, 1994. 10.13(a)** Agreement and Plan of Reorganization dated January 19, 1996. 10.13(b)** Agreement and Plan of Merger dated February 26, 1996. 10.13(c)** Escrow Agreement dated February 26, 1996. 10.14(a)** Form of Stock Purchase Warrant to Purchase shares of Series D Preferred Stock. 10.14(b)** Form of Preferred Stock Purchase Warrant. 10.14(c)** MBW and Marquette Warrants dated August 21, 1992. 10.14(d)** Schuler Warrant dated September 30, 1992. 10.15(a)** Form of Convertible Unsecured Promissory Note. 10.15(b)** Form of Convertible Unsecured Promissory Note. 10.17+ Novocastra Laboratories Ltd. Distribution Agreement dated August 19, 1992. 10.18+ LJL BioSystems, Inc. Techmate 250 Production Agreement dated May 1, 1996. 10.19* Form of Right of First Refusal. 10.20(a)* Silicon Valley Bank Loan and Security Agreement dated February 20, 1995. 10.20(b)* Amendment to Silicon Valley Bank Loan and Security Agreement dated March 28, 1996. 11.1** Statement regarding computation of Per Share Earnings. 21.1** Subsidiaries of the Registrant. 23.1** Consent of Ernst & Young LLP, Independent Auditors (see page II-7). 23.2** Consent of Ernst & Young LLP, Independent Auditors (see page II-8). 23.3** Consent of Arthur Andersen LLP, Independent Public Accountants (see page II-9). 23.4** Consent of Counsel (included in Exhibit 5.1). 24.1** Power of Attorney (see page II-4). 27.1** Financial Data Schedule.
- --------------- * To be filed by amendment. ** Previously Filed. + Confidential Treatment Requested. II-3 124 (b) FINANCIAL STATEMENT SCHEDULES No schedules have been filed herein because the information required to be set forth therein is not applicable or is shown in the financial statements or notes thereto. ITEM 17. UNDERTAKINGS The undersigned Registrant hereby undertakes to provide to the Underwriters at the closing specified in the Underwriting Agreement certificates in such denominations and registered in such names as required by the Underwriters to permit prompt delivery to each purchaser. Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to directors, officers and controlling persons of the Registrant pursuant to the foregoing provisions or otherwise, the Registrant has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the 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, the Registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue. The undersigned registrant hereby undertakes that: (1) For purposes of determining any liability under the Securities Act of 1933, 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 424(b)(1) or (4) or 497(h) under the Securities Act shall be deemed to be part of this Registration Statement as of the time it was declared effective. (2) For the purpose of determining any liability under the Securities Act of 1933, each post-effective amendment that contains a form of prospectus 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-4 125 SIGNATURES Pursuant to the requirements of the Securities Act of 1933, as amended, the Registrant has duly caused this Amendment to Registration Statement to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of Tucson, State of Arizona, on the 13th day of June, 1996. VENTANA MEDICAL SYSTEMS, INC. By: /s/ R. JAMES DANEHY ------------------------------------ R. James Danehy, President and Chief Executive Officer Pursuant to the requirements of the Securities Act of 1933, as amended, this Amendment to Registration Statement has been signed by the following persons in the capacities and on the dates indicated:
SIGNATURE TITLE DATE - ----------------------------------------------- ------------------------------ -------------- /s/ R. JAMES DANEHY President, Chief Executive June 13, 1996 - ----------------------------------------------- Officer and Director (R. James Danehy) (Principal Executive Officer) /s/ R. MICHAEL RODGERS* Vice President and Chief June 13, 1996 - ----------------------------------------------- Financial Officer (Principal (R. Michael Rodgers) Financial and Accounting Officer) /s/ REX J. BATES* Director June 13, 1996 - ----------------------------------------------- (Rex J. Bates) /s/ MICHAEL R. DANZI* Director June 13, 1996 - ----------------------------------------------- (Michael R. Danzi) /s/ EDWARD M. GILES* Director June 13, 1996 - ----------------------------------------------- (Edward M. Giles) /s/ THOMAS M. GROGAN, M.D.* Director June 13, 1996 - ----------------------------------------------- (Thomas M. Grogan, M.D.)
II-5 126
SIGNATURE TITLE DATE - ----------------------------------------------- ------------------------------ -------------- /s/ JOHN PATIENCE* Director June 13, 1996 - ----------------------------------------------- (John Patience) /s/ JACK W. SCHULER* Director June 13, 1996 - ----------------------------------------------- (Jack W. Schuler) /s/ C. ANTHONY STELLAR, M.D.* Director June 13, 1996 - ----------------------------------------------- (C. Anthony Stellar, M.D.) /s/ JAMES M. STRICKLAND* Director June 13, 1996 - ----------------------------------------------- (James M. Strickland) /s/ JAMES R. WEERSING* Director June 13, 1996 - ----------------------------------------------- (James R. Weersing) *By: /s/ R. JAMES DANEHY - ----------------------------------------------- (R. James Danehy) (Attorney in-fact)
II-6 127 EXHIBIT 23.1 CONSENT OF ERNST & YOUNG LLP, INDEPENDENT AUDITORS We consent to the reference to our firm under the caption "Experts" and to the use of our report dated February 28, 1996, except for Note 10, as to which the date is 1996, of Ventana Medical Systems, Inc. in the Registration Statement (Form S-1) and related Prospectus of Ventana Medical Systems, Inc., for the registration of 3,450,000 shares its common stock. Tucson, Arizona - -------------------------------------------------------------------------------- The foregoing consent is in the form that will be signed upon the completion of the restatement of capital accounts described in Note 10 to the consolidated financial statements. /s/ ERNST & YOUNG LLP Tucson, Arizona May 22, 1996 II-7 128 EXHIBIT 23.2 CONSENT OF ERNST & YOUNG LLP, INDEPENDENT AUDITORS We consent to the reference to our firm under the caption "Experts" and to the use of our report dated February 2, 1996, except for Note 10, as to which the date is February 20, 1996, of BioTek Solutions, Inc. in the Registration Statement (Form S-1) and related Prospectus of Ventana Medical Systems, Inc. for the registration of 3,450,000 shares of its common stock. ERNST & YOUNG LLP Tucson, Arizona May 22, 1996 II-8 129 EXHIBIT 23.3 CONSENT OF INDEPENDENT PUBLIC ACCOUNTANTS As independent public accountants, we hereby consent to the use of our report dated February 2, 1996 (except with respect to the information in Note 8 as to which the date is February 20, 1996) with respect to the financial statements of BioTek Solutions, Inc. (and to all references to our Firm included in or made a part of this Registration Statement (Form S-1). /s/ ARTHUR ANDERSEN LLP Arthur Andersen LLP Los Angeles, California May 22, 1996 II-9 130 INDEX TO EXHIBITS
EXHIBIT NUMBER DESCRIPTION ------------- ------------------------------------------------------------------------ 1.1* Form of Underwriting Agreement.
3.1(i)(a)** Restated Certificate of Incorporation, as amended. 3.1(i)(b)* Form of Restated Certificate of Incorporation to be filed after the closing of the offering made under this Registration Statement. 3.1(ii)(a)** Bylaws. 3.1(ii)(b)* Form of Bylaws to be effective on or about the closing of the Offering made under this Registration Statement. 4.1* Specimen Common Stock Certificate. 5.1** Opinion of Wilson Sonsini Goodrich & Rosati, Professional Corporation. 10.1(a)+ DAKO Distribution Agreement dated September 27, 1994. 10.1(b)+ First Amendment to DAKO Distribution Agreement dated March 24, 1995. 10.1(c)+ Further amendments to First Amendment to DAKO Distribution Agreement dated March 24, 1996. 10.2(a)* Kollsman Secured Promissory Note dated December 4, 1994. 10.2(b)* Development Secured Promissory Note dated March 24, 1995. 10.3+ Curtin Matheson Scientific, Inc. Distribution Agreement dated January 18, 1993. 10.4(a)** Restricted Stock Purchase Agreement with Jack W. Schuler dated April 19, 1996 -- Tranche 1 10.4(b)** Restricted Stock Purchase Agreement with Jack W. Schuler dated April 19, 1996 -- Tranche 2 10.4(c)** Restricted Stock Purchase Agreement with Jack W. Schuler dated April 19, 1996 -- Tranche 3 10.5(a)** Restricted Stock Purchase Agreement with John Patience dated April 19, 1996 -- Tranche 1 10.5(b)** Restricted Stock Purchase Agreement with John Patience dated April 19, 1996 -- Tranche 2 10.6* Form of Indemnification Agreement for directors and officers. 10.7(a)** 1988 Stock Option Plan and forms of agreements thereunder. 10.7(b)** 1996 Stock Option Plan and forms of agreements thereunder. 10.8(a)** 1991 Employee Stock Purchase Plan. 10.8(b)** 1996 Employee Stock Purchase Plan. 10.9** Questier Employment Agreement dated October 20, 1995. 10.10** Restated Investors Rights Agreement dated February 20, 1996. 10.11** Sublease of Premises between the Registrant and Jerry R. Jones & Associates, Inc., dated February 29, 1996, with attached Master Lease, dated October 26, 1988. 10.12** Master Lease Purchase Agreement between the Registrant and Copelco Leasing Corporation dated April 13, 1994. 10.13(a)** Agreement and Plan of Reorganization dated January 19, 1996. 10.13(b)** Agreement and Plan of Merger dated February 26, 1996. 10.13(c)** Escrow Agreement dated February 26, 1996. 10.14(a)** Form of Stock Purchase Warrant to Purchase shares of Series D Preferred Stock. 10.14(b)** Form of Preferred Stock Purchase Warrant. 10.14(c)** MBW and Marquette Warrants dated August 21, 1992. 10.14(d)** Schuler Warrant dated September 30, 1992.
131
EXHIBIT NUMBER DESCRIPTION ------------- ------------------------------------------------------------------------ 10.15(a)** Form of Convertible Unsecured Promissory Note. 10.15(b)** Form of Convertible Unsecured Promissory Note. 10.17+ Novocastra Laboratories Ltd. Distribution Agreement dated August 19, 1992. 10.18+ LJL BioSystems, Inc. Techmate 250 Production Agreement dated May 1, 1996. 10.19* Form of Right of First Refusal. 10.20(a)* Silicon Valley Bank Loan and Security Agreement dated February 20, 1995. 10.20(b)* Amendment to Silicon Valley Bank Loan and Security Agreement dated March 28, 1996. 11.1** Statement regarding computation of Per Share Earnings. 21.1** Subsidiaries of the Registrant. 23.1** Consent of Ernst & Young LLP, Independent Auditors (see page II-7). 23.2** Consent of Ernst & Young LLP, Independent Auditors (see page II-8). 23.3** Consent of Arthur Andersen LLP, Independent Public Accountants (see page II-9). 23.4** Consent of Counsel (included in Exhibit 5.1). 24.1** Power of Attorney (see page II-4). 27.1** Financial Data Schedule.
- --------------- * To be filed by amendment. ** Previously Filed. + Confidential Treatment Requested. EX-10.1(A) 2 DAKO DISTIBUTION AGREEMENT DATED SEPTEMBER 27,1994 1 EXHIBIT 10.1A DISTRIBUTION AGREEMENT This Agreement is made and entered into on this 27th day of September 1994, by and between BioTek Solutions Inc., 120B Cremona Drive, Santa Barbara, California 93117, U.S.A. a corporation organized under the laws of the State of California, hereinafter referred to as "BioTek" and DAKO A/S Productionsvej 42, 2600 Glostrup/Copenhagen, Denmark, a company organized under the laws of the Kingdom of Denmark, and its wholly or partially owned subsidiaries currently, or those interests acquired by DAKO or its subsidiaries in the future, hereinafter referred to as "DAKO." It replaces in its entirety the Distribution Agreement between the two parties, dated 1st April 1994. WHEREAS DAKO and BioTek desire to promote and sell under a dual label certain products (Schedules A and B) manufactured by or distributed for sale by BioTek; and WHEREAS BioTek and DAKO wish to promote and sell under a dual label certain reagents (Schedule C) manufactured by DAKO together with said products as an instrument system. WHEREAS the parties desire to enter into a distributorship agreement governing the terms of their relationship. NOW THEREFORE, in consideration of the respective covenants of the parties herein set forth, the parties hereto agree as follows: 2 1. PRODUCTS 1a. The Products covered by this Agreement include (i) the instruments described in Schedule A manufactured by or for BioTek, including components and base software, and parts necessary for the maintenance and repair thereof (hereinafter "Instruments"); (ii) accessories, components, buffers and supplies listed in Schedule B, manufactured by or for BioTek, (hereinafter "Accessories") and (iii) reagents listed in Schedule C, manufactured by DAKO (hereinafter "Reagents"). Schedule X contains certain accessories and components bought in by DAKO. Schedules A, B, C and X may be updated and amended from time to time by mutual consent of the parties. 1b. BioTek shall make available to DAKO on an exclusive basis any improved or updated versions and any similar or related Instruments and/or Accessories under the same terms and conditions as set forth herein. Said updated and improved Instruments and/or Accessories shall be included in Schedules A or B. DAKO shall make available to on an exclusive basis any improved or updated versions of Reagents for inclusion in Schedule C. Any and all changes in product specifications shall be mutually agreed by the parties to this Agreement. 1c. For any period during which this Agreement is exclusive (see sections 2a. and 2c below), BioTek shall offer to DAKO in writing the right to distribute, during the term of this Agreement and on the same terms and conditions (other than price) as set forth herein, any new products developed by or for BioTek, and DAKO shall have the option to accept distribution rights with respect to said new products in writing [*] of BioTek's written notice to DAKO of the availability -2- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 3 thereof. If DAKO decides not to exercise this option, BioTek may distribute, or enter into an agreement to distribute with a third party, any such new product on terms that will also be offered to DAKO. Such terms to third parties may change over time through volume discounts, price increases etc., at the sole discretion of BioTek. 1d. BioTek shall ensure that spare parts and accessories necessary for the operation and repair of any Instruments delivered to customers under this Agreement shall be available for purchase by DAKO or any DAKO customer, at their expense, including but not limited to parts, shipment and installation expenses, in such circumstances that said parts are not covered by warranties provided through DAKO (or BioTek as agreed), for the term of this Agreement. A spare parts list is attached to this Agreement (Schedule P). 1e. All products promoted and sold under this Agreement shall be promoted and sold under dual label, wherein both DAKO and BioTek labels and trademarks are of equal size and character (see Schedule D). Some components for Reagents as well as buffers required to optimize the use of instruments will be manufactured by BioTek (see Schedule B). Incorporation of components and inclusion of buffers into Reagents, and final manufacturing of Reagents and quality control will be carried out by DAKO. 1f. DAKO and BioTek have signed a Confidentiality Agreement and will treat all knowledge gained through collaboration on dual label products as trade secrets for the term of this Agreement or -3- 4 any extensions to this Agreement plus a five (5) year period following the termination of this Agreement for any reason. 2. GRANT OF DISTRIBUTORSHIP 2a. Upon the terms and subject to the conditions hereinafter set forth, BioTek hereby appoints DAKO and DAKO accepts the appointment as the exclusive distributor of Instruments and Accessories in the Territory as of the effective date of this Agreement. Except as otherwise provided in sections 3a. (ii) or 3a. (iii) below, BioTek reserves no right to distribute Instruments and Accessories in the Territory and DAKO shall have no rights under this Agreement to sell or distribute Instruments, Accessories or Reagents outside of the Territory unless mutually agreed upon by the parties. 2b. The Territory in which DAKO has the rights described in section 2a. hereof to distribute the Instruments and Accessories shall be Europe, the Middle East, India and Africa (hereinafter "Territory"). DAKO and BioTek will enter into good faith negotiations concerning (a) similar agreement(s) for Japan and South East Asia. 2c. With the exception of the conditions described in section 2d., for any period during which the arrangement between the parties for distribution of Instruments and Accessories is exclusive, DAKO shall not sell within the Territory any other automated immuno-histochemistry instrument which performs multiple functions, or any other stainer which is competitive with any current instruments -4- 5 included in Schedule A or newly-distributed instruments being made available for inclusion in Schedule A (see section 1.b), and shall not sell within the Territory any other accessories, components, buffers and supplies which are directly competitive with the Accessories described in Schedule B hereto unless otherwise mutually agreed. 2d. Notwithstanding section 2c., and limited to Italy, in the case of tenders for sale of reagents in which said tender requires DAKO to offer instruments for sale as an integral part of the tender, DAKO shall inform BioTek of such tender offers prior to submission whereupon BioTek may offer alternative sales or product options to DAKO to accommodate such tender requirements, and if this does not allow BioTek's instrument to be sold through such tenders, then DAKO shall be allowed to sell other automated immunohistochemistry instruments as part of such tenders. For the second and subsequent instruments sold to the same customer via such tenders the monthly royalty described in section 3g shall be [*] 2e. Unless otherwise specifically agreed to the contrary, during the term of the Agreement in which the arrangement between the parties for distribution of Instruments and Accessories is exclusive, BioTek shall not sell within the Territory any reagents which are specifically intended or designed for use with Instruments described in Schedule A and DAKO shall include in Schedule C any reagents which are specifically intended or designed for use with the Instruments described in Schedule A. DAKO shall, unless prohibited by customer demand, sell dual label Reagents for use on Instruments. -5- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 6 3. CONDUCT OF DAKO 3a. DAKO shall exclusively promote, distribute and sell Instruments, Accessories and Reagents during the term of this Agreement, within contract periods ("Contract Periods") as are set forth below: The first Contract Period shall commence on the date of installation at a customer location of the first Instrument in the Territory and last until 1st July 1995. Subsequent Contract Periods shall be twelve month periods beginning on the 1st July of each calendar year.
CONTRACT PERIOD NUMBER OF INSTRUMENTS PER CONTRACT PERIOD CUMULATIVE Until July 1, 1995 [*] Year 2 [*] [*] Year 3 [*] [*]
(i) The foregoing shall constitute volume targets under which the continuation of this Agreement shall be determined. DAKO shall be considered to have achieved such target if the sum of total of Instruments placed within the Territory plus firm orders to deliver, equals or exceeds the cumulative number of Instruments given above at the end of a Contract Period. (ii) Should DAKO not achieve a cumulative target, BioTek shall have the option, within thirty (30) days thereof, as its sole and exclusive remedy for failure to achieve the target, give DAKO thirty (30) days written notice of its intention to sell the Instruments and Accessories in the Territory, either directly or through third parties, as long as sales price is not less that the Transfer Prices shown in Schedules A and B. If BioTek exercises such option, DAKO may; continue to distribute -6- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 7 Instruments and Accessories on a non-exclusive basis; or DAKO may place firm Purchase Orders to make up the shortfall in sales of Instruments so long as delivery for such Instruments is within ninety (90) days; or, DAKO may elect to terminate the Agreement by providing thirty (30) days prior written notice to BioTek within thirty (30) days of receipt of said notice. Such termination shall be without liability to either party, except for such other liabilities as may otherwise specifically be set forth in this Agreement or under Law. (iii) Should DAKO not achieve a cumulative target, DAKO shall have the option, within thirty (30) day thereof, to give BioTek thirty (30) days written notice of its intention to continue to distribute Instruments and Accessories on a non-exclusive basis, or DAKO may elect to terminate the Agreement by giving ninety (90) days written notice to BioTek. Such termination shall be without liability to either party, except for such other liabilities as may otherwise specifically be set forth in this Agreement or under Law. (iv) Notwithstanding the foregoing, if DAKO is not able to achieve the target in any Contract Period due to an act or omission of BioTek or due to any event(s) which are beyond its reasonable control (e.g. section 11), such inability shall not constitute grounds for BioTek to exercise the option to sell Instruments and Accessories in the Territory, as aforesaid in section (ii). In the event that DAKO is unable to achieve the target for any Contract Period due to failure of BioTek to deliver the quantities of Instruments required to achieve the target, the target shall be deemed to have been met for that Contract Period and the cumulative numbers for subsequent Contract Periods shall be adjusted downwards by the difference between the target and the numbers of Instruments delivered. -7- 8 (v) Notwithstanding the foregoing, if at any time after 1st January 1996, a technological development occurs which substantially reduces the market for Instruments, DAKO shall have the option to [*] notice to BioTek of its intention to continue to distribute Instruments and Accessories on a non-exclusive basis for a period of [*] and may thereafter terminate this Agreement. Such notice shall be accompanied by evidence of substantial fall in Instrument placements. In these circumstances, BioTek reserves the right to give similar notice as to non-exclusivity and/or termination should such technological changes adversely effect the on-going business of BioTek as deemed solely by BioTek. 3b. DAKO shall order Instruments and Accessories hereunder by submitting firm purchase orders to BioTek. Such firm purchase orders shall be given on DAKO's purchase order form and shall be acknowledged by BioTek by facsimile within two (2) working days. 3c. In conjunction with this Agreement, DAKO has issued to BioTek firm purchase orders [*] which shall be delivered by BioTek in accordance with the provisions of section 4a. of this Agreement. 3d. DAKO may return for full credit or replacement, any Instrument or Accessory for which DAKO is required to give a customer credit or replacement Instruments or Accessories due to a defect or deficiency in the Instrument or Accessory, provided that DAKO first gives BioTek the option of repairing such Instrument on site, either through its own personnel or through the direction of DAKO personnel or contractors, with on site time and parts expenses assumed by BioTek and only -8- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 9 then, if DAKO obtains from BioTek a returned goods authorization, which shall not be unreasonably withheld or delayed by BioTek. 3e. DAKO agrees to mark Reagents (Schedule C) at the lowest saleable unit and on all packaging and inserts with BioTek's trademarks in a form and size to be mutually agreed by both parties. Such marking shall be fully described in Schedule D which schedule shall be updated from time to time. 3f. DAKO agrees to bar-code Reagents at the lowest saleable unit using symbology 3 to 9 in accordance with Health Industry Bar Code ("HIBC"). 3g. DAKO shall pay to BioTek a royalty based on TechMate 500 and TechMate 1000 Instruments that are sold and delivered to DAKO or delivered to DAKO's customers based on DAKO's drop shipment directions. Such royalty shall be paid to BioTek by DAKO for each Instrument installed by DAKO [*]. However, if DAKO requests by the [*] a next generation instrument and if BioTek by the [*] cannot demonstrate a capability to deliver such an instrument by the [*], such royalty shall be paid to BioTek by DAKO for a period of [*]. Such royalties per Instrument purchased shall be paid on a monthly basis on the first day of each calendar month, starting on the first installation date of the instrument as follows: -9- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 10
$ per month per instrument Installation to end of the calendar month (installation month) [*] First and second calendar months [*] Third and fourth calendar months [*] Fifth, sixth, seventh and eighth calendar months [*] Ninth, tenth, eleventh and twelfth calendar months [*] Thereafter [*]
Notwithstanding the above, such royalty shall not be paid for Instruments sold to Pharmaceutical companies that purchase limited amounts of dual-labeled Reagents from DAKO, but DAKO shall pay instead a [*]. In relation to the payment of these royalty fees, BioTek reserves the right and DAKO grants the right to BioTek to audit the accounts of DAKO quarterly, at BioTek's expense. 3h. DAKO shall maintain in its inventory at least such number of Instruments as may be equal to the monthly average number of Instruments installed during the [*]. DAKO will not be charged monthly royalty fees (according to section 3g) on these inventory Instruments, during the first Contract Period, until such time as they are placed at customer sites. 3i. DAKO shall at its own cost and expense provide appropriate personnel, Instruments, Accessories and Reagents to prospective customers identified by DAKO for conducting performance studies and product evaluations as may be reasonably requested by qualified prospective customers. -10- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 11 3j. DAKO will maintain at its own cost and expense, technical and sales support in the form of full-time sales personnel and other dedicated applications specialists as required at DAKO locations, for example in Milan and Paris. [*] 3k. DAKO shall establish at two separate locations, stocks of materials and Reagents (hereinafter "Reagent Stock") as a buffer against changes in supply conditions of Reagents. Each Reagent Stock shall contain materials and finished Reagent products equivalent to the requirement [*] operation of the existing placements of Instruments. 3l. If DAKO for some reason is unable to continue production and maintain Reagent Stock levels, DAKO shall inform BioTek and promptly enter into agreement with an alternative supplier (with first option to supply offered to BioTek) to obtain the necessary materials and products to maintain such Reagent Stocks. Should DAKO not be able to ensure such supply, BioTek shall have -11- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 12 the option to supply directly or indirectly such Reagent materials and products at the prices currently in effect with customers at the time DAKO ceases supply and until DAKO can resume such supply, and negotiate on a good faith basis with DAKO for payment for such supplies. 3m. BioTek will provide [*] TechMate 500 Instruments for DAKO to place into prestigious, reference laboratories where DAKO and BioTek both agree there is potential to generate significant other placements. [*] DAKO shall purchase said Instruments according to section 3b, BioTek agrees to provide these [ * ] at a billed rate of [ * ]. 3n. DAKO will provide BioTek with rolling forecasts of monthly Instrument requirements for twelve month intervals. These forecasts will be provided quarterly. The first forecast will be provided for the interval starting 1st January 1995. These forecasts shall be planning purposes only and shall not constitute a purchase order. Further DAKO will provide quarterly rolling forecasts for each quarter, based on the last two months of the preceding quarter actual orders plus twenty five percent (25%). Such quarterly forecasts will be provided 45 days in advance of the start of a quarter. DAKO will issue firm Purchase Orders at least once a month based on the above quarterly rolling forecasts. -12- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 13 3o. DAKO together with BioTek will make a weekly update of a Distribution Plan that details instruments ordered, agreed delivery and installation dates and the locations in which the Instruments shall be installed. 4. CONDUCT OF BIOTEK 4a. BioTek shall ship promptly, but in any event [*] from receipt of order, DAKO's orders for Instruments and Accessories. All orders shall be shipped f.c.a. Boston Airport (or f.o.b. Port of Boston, or such location(s) as appropriate) at which point title and risk of loss shall pass from BioTek to DAKO, freight and insurance prepaid to such location(s) as DAKO may designate. BioTek shall cooperate with DAKO in limiting drop shipments of Instruments and Accessories to DAKO to an absolute minimum. 4b. In addition to the shipments mentioned above in section 4a., BioTek shall ship to DAKO in Copenhagen by December 31, 1994, [*]. 4c. BioTek shall give [*] prior written notice of increase in price of any Instrument or Accessory and honour DAKO's purchase orders at the prices in effect immediately prior to the effective date of any price increase. -13- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 14 4d. BioTek shall notify DAKO immediately in writing should BioTek become aware of any defect or condition which renders any Instrument or Accessory in violation of any statute or regulation, or which in any way alters the specifications or quality of the Instrument or Accessory. 4e. BioTek shall execute and abide by the terms of DAKO's Continuing Guaranty (see Schedule E) incorporated herein by reference, with respect to Instruments and Accessories and DAKO shall abide by the its General Terms and Conditions of Sale with respect to Reagents. The terms and conditions of the Continuing Guaranty and the General Terms and Conditions of Sale shall survive the termination of this Agreement. 4f. BioTek shall provide DAKO with a Certificate of Insurance which meets the requirements of section D of the Continuing Guaranty on or prior to execution of this Agreement. BioTek shall provide DAKO with renewal insurance certificates in the form mandated by section D of the Continuing Guaranty during the term of this Agreement, without demand therefore by DAKO. Notwithstanding any provision of the Continuing Guaranty to the contrary, the amount of the insurance required of BioTek pursuant to the Continuing Guaranty during the first Contract Period shall be [*]; for the next subsequent Contract Period [*]; for all subsequent Contract Periods of the term of this Agreement [*]. 4g. BioTek shall provide to DAKO's Sales personnel, at Santa Barbara or at a location chosen by BioTek, training in the use, technical properties, sale competitive features and benefits of Instruments and Accessories as may be reasonably requested from time to time by DAKO. For purposes of such -14- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 15 training, [*]. 4g.(i) BioTek will provide Instrument and Accessory sales materials that will be revised only to reflect necessary changes in language. It is clearly understood by the parties that BioTek's Agreement must be confirmed in writing before any changes are made to BioTek marketing materials or before the size, graphic design, legend(s) trademark or logo of BioTek is altered, redesigned or used in any way. In general, literature will be under DAKO's corporate identity and conform with DAKO's current offerings, but will include the BioTek name and trademark in similar size and character in all dual labeling (see Schedule D). 4h. BioTek shall provide technical support to DAKO's sales personnel at sites to be determined by BioTek, and promptly provide to DAKO such additional types and quantities of technical information developed or acquired by BioTek from time to time as may reasonably be expected to be of assistance to DAKO in fulfilling its obligations hereunder. In particular BioTek shall provide technical training for DAKO's and DAKO Service Partner's field service engineers in the installation and repair of TechMate instruments. 4i. BioTek shall supply at its expense reasonable quantities of such instruction and training manuals and point of sale literature as may from time to time be requested by DAKO for use in -15- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 16 connection with the distribution and sale of Instruments in the Territory. Subject to DAKO's prior written approval, the DAKO name will be incorporated into BioTek's advertising literature for Instruments and Accessories intended for distribution by DAKO. If requested to do so by DAKO, BioTek shall furnish DAKO with suitable copy and photographs for use by DAKO in cataloguing the Instrument and Accessories. 4j. Any Instrument or Accessories owned by DAKO and rendered unsaleable due to change in any product specification, discontinuation or elimination by BioTek of any product from its product offering, release by BioTek of any improved or updated version of any Instrument or Accessory, shall be repurchased from DAKO by BioTek [*] following DAKO's written request therefore, at the price paid for such product by DAKO. BioTek shall additionally pay for return freight and related transportation and insurance charges for all such products. 4k. BioTek agrees to mark Instruments and Accessories (Schedules A and B) at the lowest saleable unit and on all packaging and inserts with DAKO's trademarks in a form and size to be mutually agreed by both parties. Such marking shall be fully described in Schedule D which schedule shall be updated from time to time. 4l. BioTek agrees to bar-code Accessories at the lowest saleable unit using symbology 3 to 9 in accordance with Health Industry Bar Code ("HIBC"). -16- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 17 4m. BioTek shall notify DAKO (and DAKO shall notify BioTek) in writing of any special requirements determined for the storage and handling of Instruments or Accessories and any laws, regulations, orders, ordinances and requirements of all local state and country governments and agencies having jurisdictions over these products. 4n. BioTek shall supply DAKO qualified leads which may come to its attention for sales or placements of Instruments in the Territory. 4o. Upon execution of this Agreement, BioTek shall provide DAKO with all necessary and appropriate information concerning all of BioTek's existing or prospective customers in the Territory, which customers shall thereafter be the customers of DAKO. BioTek shall cooperate with DAKO in notifying said customers of the appointment of DAKO as BioTek's exclusive distributor of Instruments and Accessories in the Territory and with the orderly transition of such customer accounts to DAKO. Additionally, DAKO and BioTek agree to formulate and release press and other public statements that serve to promote the announcement of their relationship and any other noteworthy events that may serve the mutual benefit of the parties. Content and copy will be mutually agreed upon by the parties. 4p. Each quarter during the first Contract Period and semi-annually thereafter, BioTek's Executive Management shall meet with DAKO's Executive Management for general business review discussions on site at BioTek or at DAKO A/S or at a DAKO subsidiary site, and mutually agreed in advance of such meetings. -17- 18 4q. BioTek shall supply and DAKO shall purchase and wharehouse, [*], stocks of materials and Accessories as a buffer against changes in supply conditions of Accessories (hereinafter "Accessory Stock"). Each Accessory Stock shall contain materials and finished Accessory products equivalent to the requirement for [*] of operation of the existing placements of Instruments. 4r. If BioTek for some reason is unable to continue production and otherwise maintain the Accessory Stock levels mentioned in section 4q. above, BioTek shall inform DAKO and promptly enter into agreement with an alternative supplier (with first option to supply offered to DAKO) to obtain the necessary materials and products to maintain such Accessory Stocks. Should BioTek not be able to ensure such supply, DAKO shall have the option to supply directly or indirectly such accessory materials and products at the prices currently in effect with customers at the time DAKO ceases supply and until DAKO can resume such supply, and negotiate on a good faith basis with BioTek for payment for such supplies. 4s. BioTek hereby confers a non-exclusive license upon DAKO under all its patents and copyrights to make, use and sell Dual Label reagents in accordance with the terms and conditions of this Distribution Agreement. BioTek shall forward to DAKO a License Agreement document in accordance with this section. In case this Distribution Agreement is terminated, the License Agreement shall survive the Distribution Agreement for a period of six months of the period necessary in order to allow DAKO to continue to supply customers in an interim period. Said License Agreement is attached as Schedule L. -18- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 19 5. PRICE AND PAYMENT TERMS 5a. BioTek shall supply and ship Instruments and Accessories to DAKO at the prices and subject to the discounts shown in Schedules A and B hereto for the duration of the first contract Period. Thereafter BioTek shall supply and ship Instruments to DAKO at prices that will be reduced by BioTek on a pro rata basis of that percentage cost change from BioTek's Instrument manufacturer to BioTek. 5b. (Deleted) 5c. BioTek agrees to negotiate with DAKO any special discounted transfer pricing: (i) on any large quantity order for instruments and/or Accessories which may be requested by any DAKO customer, (ii) where required to meet competition. In such cases of discounted transfer pricing, BioTek shall pre-approve in writing (in such format as the parties may mutually agree) any reduction in the attached schedules A or B discounted transfer prices as may be required. Notice of acceptance or rejection of each such request for pre-approval shall be communicated by BioTek to DAKO promptly following DAKO's request therefore. 5d. Payment for delivered Instruments and Accessories shall be made within current month plus [*] from the date of delivery by BioTek during the first Contract Period and within current month plus [*] from the date of delivery in all subsequent Contract Periods. -19- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 20 5e. DAKO shall be entitled to resell Instruments and Accessories intended for resale on such terms as it may, at its sole discretion, determine, including without limitation, price, returns, credit and discounts. 5f. DAKO shall exclusively promote all products listed in Schedule B including slides, pads and software. DAKO will include such products in reagent rental and reagent contracts, and will offer these products on substantially the same terms and conditions as products manufactured by DAKO. 5g. All sums due under this Agreement shall be made in United States Dollars by wire transfer and BioTek shall pay any transfer fee. 6. TERM AND TERMINATION 6a. The initial term of this Agreement shall be for a period of five (5) years starting from 27th September 1994. After said initial term, this Agreement shall terminate, unless renewed by mutual Agreement between DAKO and BioTek for additional and successive terms of [*] 6b. This Agreement shall terminate immediately upon written notice by the non-breaching party if either party (i) commits or suffers an act of bankruptcy or insolvency or, except as otherwise provided in this Agreement, (ii) fails to cure any material breach in the provisions of this Agreement within [*] after receipt of written notice of such breach. -20- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 21 6c. On the termination or non-renewal of this Agreement, howsoever arising, BioTek shall continue to honour DAKO's purchase orders for Instruments and Accessories up to the effective date of termination or non-renewal. 6d. The rights and duties of each party under this Agreement and the schedules hereto in respect of performance prior to termination or non-renewal shall survive and be enforceable in accordance with the terms of this Agreement. 6e. Upon termination or non-renewal of this Agreement BioTek shall repurchase from DAKO at DAKO's request, and at DAKO's cost therefor, such unsold Instruments and Accessories as are then owned by DAKO. Delivery of Instruments and Accessories repurchased from DAKO hereunder shall be f.c.a. DAKO's premises. 7. RIGHT OF FIRST REFUSAL 7a. If BioTek negotiates a transaction which would result in the sale by BioTek of all or substantially all of its business or its stock or assets, BioTek shall give written notice of such intention to DAKO, which shall have the option, first, after Curtin Matheson Scientific Inc., USA ("CMS") to enter into good faith negotiations for the purchase of BioTek. If CMS and BioTek are unable in good faith to agree on terms for sale [*] after the notice given by BioTek of such sale, or if CMS declines to purchase before terms are agreed, DAKO shall have the right to negotiate in good faith with BioTek to try to agree upon mutually satisfactory terms for said sale. If DAKO -21- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 22 and BioTek are unable in good faith to agree on mutually satisfactory terms for the proposed sale within a period of [*] of negotiation or if prior to expiration of said [*] period DAKO declines to purchase, then BioTek shall have the right to enter into such a transaction with any third party upon such terms and conditions as may be agreed by BioTek and any such third party. If CMS or such third party purchase all or substantially all of the business, stocks or assets of BioTek, the purchaser shall assume all of the rights and obligations of this Agreement with respect to the parties to this Agreement. 8. WARRANTIES 8a. In addition to the warranties set forth in this Agreement and in the Continuing Guaranties which are attached hereto as Schedule E, BioTek and DAKO warrant that each of the products will conform to specifications set forth in the product literature prepared respectively by or on behalf of BioTek or DAKO and that said products will comply and be manufactured, packaged, sterilized (if applicable), labeled and shipped in compliance with all applicable Federal, state and local laws, orders, regulations and standards. In particular BioTek shall ensure that Instruments conform to EU instrument specifications and shall issue any necessary certification to this effect. 8b. BioTek represents and warrants that Instruments and Accessories supplied to DAKO under this Agreement shall not infringe upon the patients or proprietary rights of any third party. To the extent that any third party owns any patents or proprietary rights relating to Instruments or Accessories or to their manufacture, BioTek represents and warrants that it has obtained valid license -22- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 23 rights from such third party to manufacture and sell Instruments and/or Accessories. Similarly DAKO warrants that Reagents manufactured by DAKO under this Agreement shall not infringe upon the patents or proprietary rights of BioTek or any third party. To the extent that any third party owns any patents or proprietary rights relating to Reagents or to their manufacture, DAKO represents and warrants that it has obtained valid license rights from such third party to manufacture and sell Reagents. 8c. BioTek shall extend to DAKO customers its Suppliers' Warranties for Instruments and Accessories which are set forth in Schedule F. BioTek shall not modify any product Warranty without notifying DAKO with at least [*] notice. BioTek warrants and represents that the products will perform in accordance with, and that BioTek shall strictly comply with, the terms of BioTek's product Warranties. DAKO's warranty for Reagents is included under the General Terms and Conditions of Sale (Schedule E). 9. TRADEMARKS 9a. BioTek hereby grants to DAKO the royalty-free right to use the trademarks: BioTek; TechMate; and ChemMate (see also Schedule D), on dual-labeled Reagents during the term of this Agreement within the Territory, it being expressly understood that DAKO shall discontinue the use of such trademarks upon termination of this Agreement (except in connection with the distribution and sale of DAKO's remaining inventory of Reagents or of Instruments or of Accessories in the event that -23- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 24 DAKO does not elect to exercise its rights under section 6e hereof) and disclaim any rights in the trademarks other than the said licence. 9b. DAKO hereby grants to BioTek the royalty-free right to use DAKO's trademarks on Instruments and Accessories within the Territory and during the term of this Agreement, it being expressly understood that BioTek shall discontinue the use of such trademarks upon termination of this Agreement and disclaim any rights in the trademarks other than the said licence. 9c. BioTek recognizes that DAKO is the owner of the trademarks and tradenames denoting DAKO or DAKO products which DAKO may elect to use in the promotion and sale of Instruments and Accessories and that BioTek has no right or interest in such trademarks or tradenames. Similarly, DAKO recognizes that BioTek is the owner of the trademarks and tradenames denoting BioTek or BioTek products which BioTek may elect to use in the promotion and sale of products and that DAKO has no right or interest in such trademarks or tradenames. 10. CONFIDENTIALITY 10a. Each party acknowledges the confidential nature of information that may be disclosed hereunder (including but not limited to names of customers and other marketing-related information) and agrees to retain such information in confidence. This provision shall survive the termination of this Agreement for a period of three (3) years. Confidential information (especially technical -24- 25 information) may also be the subject of separate confidentiality agreements which the parties enter into. 11. FORCE MAJEURE 11a. The obligations of either party to perform under this Agreement shall be excused during each period of delay caused by such matters as strikes, shortages of power or raw material, government orders or acts of God, which are reasonably beyond the control of the party obligated to perform. The affected party shall make best efforts to remedy the effects of such Force Majeure. Any Force Majeure event shall not excuse performance by the party, but shall delay performance, unless such Force Majeure continues for a period in excess of [*]. In such event, the party seeking performance may cancel its obligations hereunder. 12. NOTICES 12a. Any notice required by this Agreement shall be deemed sufficient if sent by certified mail, postage prepaid, to the party to be notified at the address set forth in the initial section of this Agreement until notice of a different address is supplied and if receipt is acknowledged by the receiving party. -25- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 26 12b. The parties to this Agreement shall give notification of any technical problems or delays, or of any production difficulties of significance. Such notice shall be given by facsimile with documentation and estimates of expected recovery time. 13. ENTIRE AGREEMENT 13a. This Agreement including the Schedules hereto, constitutes the entire Agreement between the parties relating to the subject matter hereof and supersedes all prior agreements and understandings, whether written or oral, between the parties with respect to such subject matter. In ordering and delivery of products, the parties may employ their standard forms, but nothing in these forms shall be construed to modify or amend the terms of this Agreement. 14. APPLICABLE LAW 14a. This Agreement shall be governed by the laws of the State of California. In the event of a dispute arising in any manner out of or in relation to this Agreement, the parties shall attempt in good faith to amicably resolve such dispute. Any disputes which cannot be amicably resolved shall be referred by one party for resolution by arbitration according to the rules of the International Chamber of Commerce. The language of arbitration shall be English and arbitration shall take place at a place determined by the non-referring party. -26- 27 15. ASSIGNMENT AND SUCCESSION 15a. This Agreement shall not be assigned or transferred by BioTek either voluntarily or by operation by law without the prior written consent of DAKO. 15b. This Agreement shall inure to the benefit of and be binding upon the parties hereto and their permitted successors and assigns. 16. AMENDMENTS 16a. No amendment or modification of the terms of this Agreement shall be binding on either party, unless reduced to writing and signed by an authorized officer of the party to be bound. 16b. BioTek and DAKO will enter into a Development Agreement that will set forth the terms and conditions under which the work by developing new Reagents and Accessories shall be defined. Said Agreement will become an integral part of the present Agreement when it is agreed in writing by both BioTek and DAKO. DAKO will facilitate a meeting of representatives of BioTek, DAKO and appropriate DAKO subsidiaries to discuss, develop and execute said Development Agreement. -27- 28 17. EXISTING OBLIGATIONS 17a. Each party represents and warrants that the terms of this Agreement do not violate any existing obligations or contracts of such party. Each party shall defend, indemnify and hold harmless the other party from and against any and all claims, demands, liabilities and causes of action which are hereafter made or brought against such other party which allege any such violation. 18. RELATIONSHIP OF THE PARTIES 18a. Nothing herein contained shall be deemed to be or construed as constituting either party as the agent or partner of the other. 19. COUNTERPARTS 19a. This Agreement may be executed in one or more counterparts, each of which shall be deemed an original for all purposes. -28- 29 IN WITNESS WHEREOF, the parties have by their duly authorized officers, executed this Agreement on the dates set forth below. FOR BIOTEK SOLUTIONS INC. /s/ Michael C. Miller - ------------------------- Michael C. Miller President and CEO FOR DAKO A/S /s/ Torben Jorgensen /s/ John F. Place - ------------------------- ---------------------------- Torben Jorgensen John F. Place MA Managing Director Business Development Manager -29- 30 SCHEDULE A: INSTRUMENTS TECHMATE 500 includes 386SX PC computer (486 Diamond Flower DFI) with colour monitor and mouse, BioTek basic system software, 3 slide holders, uninterruptable power supply and multiplug panel, free Warranty service (including parts and cure of any manufacturing defect) for a period of one year from the date of installation, user manual, service manual. TRANSFER PRICE [*] (See also section 6a) TECHMATE 1000 includes 386SX PC computer (486 Diamond Flower DFI) with colour monitor and mouse, BioTek basic system software, 3 slide holders, uninterruptable power supply and multiplug panel, free Warranty service (including parts and cure of any manufacturing defect) for a period of one year from the date of installation, user manual, service manual. TRANSFER PRICE [*] (See also section 5a) -30- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 31 Hybridization Oven (available on or after 1st July 1995)
TRANSFER PRICE 75/100um Slides (per 72) [*] 130/150um Slides (per 72) [*] Pads (per 50) [*] Software upgrade (per year) [*] Hematoxylin (350 ml) [*] Chromgens: Alkaline phosphaltase [*] DAB [*]
Reagent trays shall be provided in reasonable quantities by BioTek at no charge to DAKO. The following buffers shall be provided in bulk, in reasonable quantities sufficient for DAKO to prepare the kits and Reagents, at no charge to DAKO. Buffers SDK 1, 2 and 3 Water wash Microwaving buffer MWB101 Hydrogen peroxide blocking reagent -31- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. EX-10.1(B) 3 1ST AMENDMENT TO DAKO DISTRIBUTION AGRREMENT 1 EXHIBIT 10.1B FIRST AMENDMENT TO DISTRIBUTION AGREEMENT THIS FIRST AMENDMENT TO DISTRIBUTION AGREEMENT (this"Amendment") is between BIOTEK SOLUTIONS, INC., a California corporation ("BioTek"), and DAKO A/S, a Danish corporation ("DAKO"). RECITALS: A. BioTek and DAKO are the parties to that certain Distribution Agreement dated September right to distribute in specified territories BioTek's TechMate 500 and TechMate 1000 products and the related Accessories; B. BioTek is now developing for sale a compact, competitive and cost-effective new generation of TechMate Instrument (the "New TechMate") to be marketed to customers not wishing to make a more substantial capital investment or who lack the slide volumes to justify purchase of the TechMate 500 or the TechMate 1000; C. Paragraph 1c of the Agreement provides that during the period in which the Agreement is exclusive BioTek shall offer to DAKO in writing the right to distribute new products developed by BioTek, such as the New TechMate, on the same terms and conditions (other than price) governing the sale of the TechMate 500 and TechMate 1000; D. BioTek has requested that DAKO fund the development of the New TechMate; E. BioTek has therefore offered to DAKO the right to distribute the New TechMate under the Agreement; F. The parties by this Amendment desire to include the New TechMate as one of the "Instruments" covered by the Agreement, subject to the modifications set forth in this Amendment; and G. The parties desire to make a number of changes in the Agreement. NOW, THEREFORE, the parties hereto agree as follows: 2 SECTION 1 AMENDMENT The Agreement is hereby amended as set forth on Exhibit A hereto (which Exhibit is incorporated herein by this reference) and as follows: 1.1 Additions to Territory. Subsection 2b is hereby amended by deleting the second sentence and by replacing it with the following: "BioTek hereby grants to DAKO an option to include the following countries and/or regions in the Territory: Canada, South America, Australia, New Zealand, Japan, Southeast Asia, Central America and Mexico (each, an "Option Area") on the following terms: (i) The royalty payable with respect to Instruments sold within any such Option Area shall be that standard royalty set forth at Schedule G hereto and in 3g(i) below (for the TechMate 500 and the TechMate 1 000) and that royalty set forth in 3g (ii) below (for the New TechMate) or any such royalty as hereafter may be agreed to by the parties hereto in writing. (ii) The term of this option shall coincide with the term of this Agreement. (iii) In the event that, prior to any exercise by DAKO of this option respecting any of the above Option Areas, BioTek desires to enter into an agreement to distribute the Instruments in such Option Area with a third party, BioTek shall give to DAKO written notice of such intent. DAKO shall thereafter have 30 days to determine whether it wishes to exercise its option relating to such Option Area. If DAKO declines to exercise its option, BioTek shall have a period of 90 days after the end of such 30-day period during which to enter into a written distribution agreement with a third party respecting such Option Area. If BioTek enters into such distribution agreement, DAKO's option hereunder with respect to such Option Area will terminate. If BioTek does not enter into a written contract before the expiration of such 90-day period, DAKO"s option for such Option Area will be restored." 1.2 Royalties Per Instrument. Subsection 3g is hereby amended and restated in its entirety to read as follows: "3g. (i) TechMate 500 and 1000. DAKO shall pay to BioTek the royalties set forth in Schedule G hereto with respect to TechMate 500 and TechMate 1000 Instruments that are sold and delivered to DAKO or delivered to DAKO's customers based on DAKO's drop shipment directions. Such royalty shall be paid to BioTek by DAKO for each Instrument installed by DAKO [*]. However, if DAKO -2- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 3 requests by the end of [*] a next generation instrument and if BioTek by the end [*] cannot demonstrate a capability to deliver such an instrument by the end of year five, such royalty shall be paid to BioTek by DAKO for a period of [*] only. Such royalties per Instrument purchased shall be paid on a monthly basis on the first day of each calendar month, starting on the first installation date of the Instrument. Notwithstanding the above: (1) The royalty payable during the ninth, tenth, eleventh and twelfth months and thereafter will increase only to a maximum of [*] for a maximum of [*] solely for DAKO's European distributors in the following countries: Spain, Holland, Belgium, Austria, Norway, Finland and Slovenia. (2) Such royalty shall not be paid for Instruments sold to pharmaceutical companies that purchase limited amounts of dual-labeled Reagents from DAKO, but DAKO shall pay instead a quarterly fee equal to [*] sold by DAKO for use on such Instruments. (3) Any Instrument installed after September 27, 1997 in any country in a hospital which already has one royalty-bearing Instrument installed, shall be [*]. However, if the volume of Reagents sold by DAKO for use in the Instruments installed in such hospital in any [*] exceeds [*] the average volume sold to hospitals with only one Instrument during that period, then DAKO shall, with effect from the end of that [*] pay royalties for [*] with such payments being made retroactive to the date of installation of the second Instrument. (4) If DAKO's total volume of Reagents sold to a particular customer for use in an Instrument over [*] is reduced by more than [*] compared to the [*], then the royalty payable by DAKO with respect to such Instrument for the rest of the royalty period shall, commencing with the month following such calculation, be calculated instead at [*] by DAKO in each month (converted into US$ according to the exchange rate in effect at the end of such month). The relevant 12-month periods shall be the [*] installation and each subsequent 12-month period. (5) DAKO agrees that, with respect Instruments sold in Sweden, The United Kingdom a France, in recognition of the royalty reduction to maximum of [*] in such countries as stated Schedule G, there may be an increase in the royalty paid to BioTek by DAKO, calculated [*] of use -3- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 4 of an Instrument by any customer in the three aforementioned countries if there is a sufficient increase in Reagent purchases by any one customer in any of such countries as determined by the following formula: Reagent sales for months [*] in excess of Reagent sales for months [*] (inclusive), reflected as a percentage increase, will be adjusted by [*] points from any such percentage. Such reduced percentage (if positive) will be the percentage increase in royalty, retroactive to [*] of customer use and will create the new royalty to apply from and after such [*]. This adjustment will be made again [*] of the royalty period, and any increase adjusted retroactively, if applicable, for the prior [*]. The base period, for purposes of calculating the royalty adjustment at months [*], will also be the months [*]. (ii) New TechMate. DAKO shall pay to BioTek a royalty based on the New TechMate Instruments that are sold and delivered to DAKO or delivered to DAKO's customers based on DAKO's drop shipment directions. Such royalty shall be paid to BioTek by DAKO for each Instrument installed by DAKO for [*]. Such royalties per Instrument purchased shall be paid on a monthly basis on the first day of each calendar month, starting on the first installation date of the Instrument as follows:
$ per mont per instrument ---------- Installation to end of the calendar month [*] (installation month) First and second calendar months [*] Third and fourth calendar months [*] Fifth and sixth calendar months [*] Seventh, eighth and ninth calendar months [*] Tenth, eleventh and twelfth calendar [*] months
Thereafter, the royalty figure shall increase [*] by an amount equal to [*] per annum, with the first increase commencing on the first anniversary of the first shipment of the New TechMate. (For example, on such first anniversary, the royalty for each installed Instrument shall increase to [*].) -4- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 5 Notwithstanding the above, such royalty shall not be paid for Instruments sold to pharmaceutical companies that purchase limited amounts of dual-labeled Reagents from DAKO, but DAKO shall pay instead a quarterly fee [*] after the end of each quarter equal to [*] sold by DAKO for use on such Instruments. (iii) Deinstalled Instruments. In the event that an Instrument is returned by a customer of DAKO or is otherwise removed from service, such Instrument shall not be counted for purposes of calculating the above royalties until the shorter of (x) such time as such Instrument is reinstalled, or (y) [*], at which time the royalty payable with respect to such Instrument will recommence pursuant to the applicable royalty schedule." 1.3 Free and Discounted Units. Section 4(c) of the Agreement is hereby amended and restated in its entirety to read as follows: "4c. BioTek shall ship to DAKO, as soon as they. are available, [*] for use as demonstration units, and, upon request by DAKO, [*] discount from the transfer price set forth in Schedule A (before any recoupment hereunder). If any of such [*] are sold by DAKO to customers, such sale shall be subject to the terms and conditions of this Agreement, including, without limitation, the payment of the standard royalty set forth at Schedule G hereto and at 3g(ii) of this Agreement." Section 5(d) of the Agreement is hereby amended and restated in its entirety to read as follows: "5d. Until the start of the second Contract Period, that is, through July, 1995, payment for shipped Instruments and Accessories shall be received by BioTek, via wire transfer, on the fifth (5th) and the twentieth (20th) of each month for those invoices outstanding, so long as such invoices have been received in hard copy form by DAKO, with accompanying documentation of direct shipments to DAKO or drop shipments directly to DAKO customers. BioTek may submit such invoices to DAKO at time of shipment, with confirmation. Beginning August 1, 1995 and thereafter, payment shall be made by the fifth (5th) of each month on the remaining terms as described above. In the event that the fifth (5th) or the twentieth (20th) day of a particular month is not a business day, any payments due pursuant to this Section 5d shall be made on the next day which is a business day." 1.4 Extension of Term. Subsection 6a of the Agreement is amended to read in its entirety as follows: "6a. (i) Term. The initial term of this Agreement shall be for a period starting on September 27, 1994 and ending on December 31, 1999 (the "Initial Term"). After such Initial Term, the term of this Agreement shall automatically be extended for an additional one (1) year period (the "Second Term") unless DAKO -5- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 6 gives BioTek written notice that it desires to terminate this Agreement at the end of the Initial Term, which notice must be delivered on or before the end of the 4th year of the Initial Term. Either party can terminate this Agreement (effective after the Second Term) by [*] notice to the other party of its intention to terminate this Agreement. Any termination may be either: (x) in its entirety or (y) only with respect to the exclusive nature of the rights and obligations of the parties hereunder such that this Agreement becomes a non-exclusive distribution agreement. (ii) Repayment on Termination. ln the event that the full amounts of the Kollsman Prepayment (defined below) and the Development Prepayment (defined below) have not been recouped by DAKO pursuant to the terms of Sections 20b and 21e below, then: (x) If such termination is made by BioTek, any and all unrecouped amounts shall be immediately due and payable in accordance with the terms of the Kolisman Note and the Development Note, respectively; and (y) if such termination is made by DAKO (other than due to a material breach by BioTek in its obligations hereunder, in which case such termination shall be treated as a termination by BioTek pursuant to (x) above), any and all unrecouped amounts shall be payable [*] in accordance with the terms of the Kollsman Note and the Development Note, respectively (unless such quarterly installments had otherwise already commenced in accordance with the terms of this Agreement, in which case such quarterly installments shall continue as if there had been no termination.)" 1.5 Warranties. Section 8 of the Agreement is hereby amended to include the following subsections at the end thereof: "8d. Indemnification. BioTek will indemnify and defend DAKO against, and hold DAKO harmless from, any loss, cost, liability or expense (including court costs and reasonable fees of attorneys and other professionals) arising out of or resulting from any breach or claimed breach of the above warranties and representations and from any claim that DAKO's exercise of the rights granted to it herein, anywhere in the Territories or agreed upon Option Areas, infringes any intellectual property and/or proprietary right of any third party. In the event of any such claim, DAKO agrees promptly to notify BioTek of the claim and to permit BioTek, at BioTek's expense, to defend such claim with counsel of BioTek's choosing reasonably acceptable to DAKO. Notwithstanding the above, BioTek shall have no liability for any claim of infringement based upon use or combination by DAKO of the Intellectual Property Rights with other intellectual property not provided by BioTek, if such infringement would have been avoided but for such use or combination. 8e. Perfection. If the exercise by DAKO of any rights granted to DAKO herein is enjoined, at DAKO's request and option, and without prejudice to DAKO's other rights and remedies, BioTek at its expense will: (i) procure from the person or persons -6- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 7 claiming infringement a license for DAKO and its licensees and sublicensees to continue to exercise all rights granted under this Agreement with respect to the Intellectual Property Rights, or (ii) modify the allegedly infringing item to avoid the infringement, if that can be done promptly and without materially impairing performance or compliance with the specification for the involved item or otherwise impairing DAKO's rights and benefits under this Distribution Agreement. 8f. New TechMate. NOTWITHSTANDING THE ABOVE WARRANTIES MADE BY BIOTEK, BIOTEK MAKES NO WARRANTY, EXPRESS OR IMPLIED, WITH RESPECT TO THE SUCCESS OF THE RESEARCH AND DEVELOPMENT EFFORT FOR THE NEW TECHMATE AND EXPRESSLY DISCLAIMS ANY WARRANTY OF MERCHANTABILITY, DESCRIPTION OR FITNESS FOR ANY PARTICULAR PURPOSE OR FUNCTION. 8g. Rights. DAKO expressly acknowledges that performance of this Agreement by BioTek, as it relates solely to the development of the New TechMate, may result in the development of new proprietary concepts, methods, patents, techniques, processes and ideas. The parties agree that the foregoing and any other item developed hereunder shall belong solely and exclusively to BioTek without regard to the origin thereof, subject, however, to the special licenses in DAKO's favor as described at Subsection 21(h) and Section 22 of this Agreement, as amended. BioTek acknowledges that, as the owner of the proprietary rights described above, it is solely responsible for paying for all of the legal expenses necessary to file and finalize any patents or trademarks. During the term of this Agreement any patent developed as a byproduct of the development described in this Agreement will be made available by BioTek to DAKO under an irrevocable license in accordance with the circumstances described in this Agreement, as amended. BioTek will have the first option to patent any research developed under this Agreement. If BioTek elects not to patent any such patentable research, then it will so notify DAKO in writing, signed by the president of BioTek, and DAKO will have the right after receipt of such written notice to patent such research." 1.6 Notice. Section 12 of the Agreement is hereby amended in its entirety read as follows: "12. Notices. All notices, requests, demands, and other communications required to or permitted to be given under this Agreement shall be in writing and shall be conclusively deemed to have been duly given (1) when hand delivered to the other party; or (2) when received when sent by telex or facsimile at the address and number set forth below (provided, however, that notices given by facsimile shall not be effective unless either (a) a duplicate copy of such facsimile notice is promptly given by depositing same in a United States or Denmark post office (as applicable) using certified or registered mail and addressed to the parties as set forth below, or lb) the receiving party delivers a written confirmation of receipt for such notice either by facsimile or any other method permitted -7- 8 under this paragraph; additionally, any notice given by telex or facsimile shall be deemed received on the next business day if such notice is received after 5:00 p.m. (recipient's time) or on a nonbusiness day); or (3) fourteen (1 4) business days after the same have been deposited in a United States or Denmark post office (as applicable) with registered or certified mail return receipt requested postage prepaid and addressed to the parties as set forth below; or (4) the two business days after same have been deposited with a national overnight delivery service reasonably approved by the parties (Federal Express and DHL WORLDWIDE Express being deemed approved by the parties), postage prepaid, addressed to the parties as set forth below with two business days delivery guaranteed, provided that the sending party receives a confirmation of delivery from the delivery service provider. To: Mr. Torben Jorgensen To: Mr. Michael Miller Managing Director BioTek Solution, Inc. DAKO A/S 120 B Cremona Drive Produktionsvei 42 Santa Barbara, CA 93117 DK-2600 Glostrup Tel: 805/562-3888 Denmark Fax: 805/562-3890 Tel: 4544920044 Fax: 4542841822 with a copy to with a copy to Per Carsten Pedersen Joseph L. Cole Pedersen & Jantzen Seed, Mackall & Cole Nyropsgade 45 1332 Anacapa Street DK-1 602 Copenhagen V Santa Barbara, California 93101 Denmark Tel: 805/963-0669 Tel: 4533129512 Fax: 805/962-1404 Fax: 4533129515 Each party shall make an ordinary, good faith effort to ensure that it will accept or receive notices that are given in accordance with this Section, and that any person to be given notice actually receives such notice. A party may change or supplement the addresses given above, or designate additional addresses, for purposes of this Section by giving the other party written notice of the new address in the manner set forth above." 1.7 Independent Contractors. Section 18 of the Agreement is hereby amended in its entirety to read as follows: "18a. Each party acknowledges that the relationship between the parties pursuant to this Agreement is that of independent contractors. No provision of this Agreement shall be construed to (i) constitute the parties as partners, joint venturers or -8- 9 participants in a joint undertaking, or (ii) give either party the power to direct and/or control the day-to-day activities of the other." 1.8 Kollsman and Development Funding. The Agreement is hereby amended by inserting the following Sections after Section 19: "20. Kollsman Prepayment. 20a. Transfer of Prepayments. DAKO has transferred funds to Kollsman totaling [*] for DAKO's purchases of TechMates 500 and 1000 under this Agreement (the "Kollsman Prepayment"). Any outstanding balance of the Kollsman Prepayment shall bear interest [*] per annum calculated and paid quarterly in arrears from the date of disbursement by DAKO to Kollsman in accordance with the terms of the Kollsman Note (as defined below). 20b. Recoupment of Kollsman Prepayment. DAKO shall recoup the Kollsman Prepayment by receiving the following credits with respect to each TechMate 500 and/or TechMate 1000 sold and delivered to DAKO or a customer of DAKO, until such time as all of the Kollsman Prepayment has been recouped: (i) Respecting the [*] shipped before [*]; (ii) Respecting each TechMate 500 or 1000 ordered thereafter, [*]; provided, however, that in the event of a Milestone Default (as defined in Subsection 21d(i) below) with respect to the last Milestone, the amount of such credit shall thereafter [*]; and (iii) The obligation of BioTek to repay the Kollsman Prepayment shall be evidenced by a promissory note substantially in the form of Exhibit B hereto (the "Kollsman Note"). 21. New TechMate Development. 21a. BioTek hereby agrees to develop the New TechMate so that it is ready for sale in accordance with the development milestones (inclusive of timetable), budgets and benchmarks set forth at Schedule H (collectively, the "Milestones"). A description of the New TechMate development project is attached hereto as Schedule 1. 21b. Development Committee. BioTek agrees to establish a Development Committee to oversee development of the New TechMate. The Development Committee shall be chaired either by Mr. Robert Case or a designated Chairman appointed by BioTek. In addition to such chairperson, the Development Committee will consist of two representatives named by BioTek, two representatives named by DAKO, and a maximum of four other representatives to be -9- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 10 appointed by Mr. Case or such other Chairman, for a maximum committee of nine representatives. Case & Associates or such other chairman (or his or her affiliate) shall be a party to a Project Management Agreement with BioTek, a copy of which shall be provided to DAKO within. 10 days after execution thereof. 21c. Development Funding. DAKO hereby agrees to provide [*] ("Development Prepayment") to BioTek in order to fund the development of the New TechMate in accordance with the following provisions: (i) Release of Development Funds. The first installment of the Development Prepayment will be paid by DAKO within five (5) business days after the Effective Date (defined below) and will equal the amount budgeted for the first Milestone as indicated on Schedule H. Thereafter, within seven business days from having received the notice described below that a Milestone has been completed, DAKO shall pay the next installment of the Development Prepayment to BioTek in an amount equal to the budgeted amount for the subsequent Milestone as indicated in Schedule H. The Chairman of the Development Committee shall notify DAKO in writing of the satisfaction of each Milestone. Reasonable additional documentation respecting the accomplishment of such Milestone shall accompany such notice. The intent of this Agreement is that BioTek shall be paid only for its actual costs in reaching each Milestone, excluding any markup for profit. While installments of the Development Prepayment will be paid in the amount of the budgeted amounts described at Schedule H, [*] after the end of each calendar quarter BioTek shall provide DAKO with the actual costs for any Milestones achieved and paid for in the preceding quarter. If the paid installments exceed the actual costs so reported, then the next Milestone payment shall be reduced by any such excess amount. If actual costs exceed the paid budgeted amount, DAKO shall after written submission by BioTek of evidence of such actual costs, increase the next Milestone payment by the amount of such excess amount: provided however, that if such excess amount applied on an aggregate basis after taking into account any shortfalls or overpayments from all earlier Milestones is [*] of the amount budgeted in the aggregate to such Milestone, then the next Milestone payment shall be increased by [*] of such aggregate excess amount and BioTek shall be responsible for funding the balance of such excess. DAKO shall otherwise have exclusive control over any disbursements. DAKO's total funding to this subsection (i) [*]. (ii) Additional Prepayments. The parties acknowledge that the expenses of developing the New TechMate [*] amount described above, due to the uncertainties inherent in the research and development process. If the costs of development of the New TechMate in fact [*], the parties each agree to extend matching funds up to a maximum of -10- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 11 [*], with the disbursements by DAKO continuing to benefit from the controls available to it under subsection (i) above. The obligation of BioTek to repay any such increase in additional disbursed funds shall be evidenced by the Development Note. Any development funds in [*] would be extended solely by BioTek. (Furthermore, reference is made to Subsection 2ld(ii) below.) (iii) No Further Obligation. Nothing herein contained shall be deemed to create an obligation on the part of DAKO to pay any amount over the amounts described in Subsections (i) and (ii) above. (Furthermore, reference is made to Subsection 2ld(ii) below.) 21d. Termination of Funding. (i) Failure to Achieve Milestones. DAKO shall have the right to discontinue funding the development of the New TechMate prior to the completion of such development in the event that: (x) [*] late in completing any one of the Milestones; (y) after such 60-day period DAKO delivers to BioTek written notice of such lateness (the "Failure Notice"); and (z) BioTek fails to complete such Milestone [*] receipt of the Failure Notice (such events collectively shall constitute a "Milestone Default"). In the event of a Milestone Default, DAKO [*] determine if: (1) it wishes to exercise the Development License (defined below); or (2) it wishes to trigger the repayment of the Development Note (defined below) in twelve equal quarterly installments in accordance with the terms of the Development Note. On or before the end of [*] DAKO shall provide notice to BioTek of which of either "1" or "2" above DAKO has chosen. If DAKO chooses option "1" above, any amounts that it spends thereafter on development of the New TechMate shall not be added to the principal amount of the Development Note, but shall count nonetheless as Development Prepayments for purposes of recoupment only pursuant to subsection 2le below. If DAKO chooses option "2" above: (A) DAKO shall have no right to distribute the New TechMate under this Distribution Agreement and shall have no ownership interest in the New TechMate, including without limitation any intellectual property rights relating thereto; (B) BioTek shall retain all right, title and interest in and to all work in process and intellectual property and all other rights respecting the New TechMate and any related technology; and (C) BioTek's sole obligation to DAKO respecting the Development Prepayments made up to such date shall be represented by the Development Note and related security documents. (ii) Discontinuance At Will. DAKO shall have the right at any time in its sole discretion to discontinue funding the development of the New TechMate prior to its completion [*] after delivery of written notice (the -11- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 12 "Discontinuance Notice") to BioTek to that effect. If such discontinuance is for any reason other than BioTek's failure to meet Milestones as described in (i) above, DAKO agrees to meet with BioTek to discuss the reasons for such discontinuance in order to attempt to resolve the issues involved in DAKO's decision to discontinue. If the parties determine that they are unable to resolve the issues, DAKO shall send BioTek written notice (the "Termination Notice") that DAKO has permanently terminated funding the development of the New TechMate. If DAKO decides in any event to disengage from any further development or otherwise stops its funding (other than for the failure to meet Milestones as described in (i) above): (1) DAKO shall have no right to distribute the New TechMate under this Distribution Agreement and shall have no ownership interest in the New TechMate, including without limitation any intellectual property rights relating thereto; (2) BioTek shall retain all right, title and interest in and to all work in process and intellectual property and all other rights respecting the New TechMate and any related technology; and (3) BioTek shall have no obligation to DAKO respecting the Development Prepayments made up to such date, including without limitation, any obligation to repay the Development Note. This means, without limitation, that any discounts, rebates or other recoupment described in this Agreement shall not apply, except for recoupment obligations under the Kollsman Note as provided herein. This also means without limitation in such event that: (1) DAKO waives and holds BioTek harmless from any and all amounts which may be due under the Development Note, and, upon written demand by BioTek, DAKO shall return to BioTek the signed original of such Development Note; and (2) DAKO shall pay all amounts necessary to satisfy any prospective contracts or commitments to any third parties for goods or services entered into by BioTek under the Milestones before the date of the Discontinuance Notice (the "Commitments") [*] written demand and submission of satisfactory evidence to DAKO of such Commitments, provided, however, that DAKO's obligation hereunder to pay such Commitments [*]. 21e. Recoupment of Development Prepayment. (i) DAKO shall recoup the Development Prepayment as follows: A. By receiving a discount on each New TechMate sold and delivered to DAKO or to a customer of DAKO [*] of BioTek's markup over its per unit cost (or "margin") for the New TechMate (which unit cost for the purposes hereof [*]; B. After the Kollsman Prepayment has been fully recouped, by receiving a discount on each TechMate 500 and TechMate 1000 sold and delivered to DAKO or to a customer of DAKO, the recoupment amount then in effect pursuant to subsection 20b above; -12- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 13 C. By receiving a payment from BioTek with respect to each New TechMate sold by BioTek to any other party for resale, and/or use in any territory other than the United States, in an amount equal to the discount in effect under (A) above, which payment BioTek shall send to DAKO quarterly; and D. By receiving from BioTek $250 per New TechMate sold in the United States, with such payment occurring on a quarterly basis, until such time as recoupment of the Development Prepayment is satisfied. (ii) The obligation of BioTek to repay the Development Prepayment shall be evidenced by a promissory note substantially in the form of Exhibit C hereto (the "Development Note"). 21f. Failure of Adequate Sales. Notwithstanding the above, other than as may be permitted in this Agreement, if, following the full market release of the New TechMate, DAKO fails to [*] after such full market release (the "Fifteen Month Period"), then, upon written notice by DAKO to BioTek (a "Sales Failure Notice"), the amounts due under the Development Note shall thereafter become immediately payable in twelve quarterly payments in accordance with the provisions of the Development Note and DAKO shall have only non-exclusive rights hereunder to distribute the New TechMate in the Territory, unless, however, before the end of the Fifteen Month Period BioTek notifies DAKO of its election to cure such sales deficiency during the additional six month period described below. If BioTek makes such written election to attempt such cure, the issuance of the Sales Failure Notice shall be stayed until the end of the six month cure period described below. If DAKO fails to [*], then, after the written notice by BioTek to DAKO, BioTek shall have the right, but not the obligation, to satisfy this threshold by BioTek's sales personnel or agents achieving the remaining New TechMate installations in the Territories over the course of the next six (6) months following the Fifteen Month Period as may be necessary to satisfy [*]. If BioTek successfully sells the remaining number of New TechMates necessary to achieve the [*], then there shall be no "Failure Notice" issued by DAKO to BioTek. DAKO will retain its rights to exclusive distribution in the Territories under these circumstances. If BioTek in such circumstances does not successfully sell the remaining number of New TechMates necessary to achieve [*], then the Failure Notice will issue at the end of such six month period. It is expressly agreed that BioTek cannot use New TechMate's which have been installed by it but not sold by it in order to meet [*]. Accordingly, the threshold will only be met by adding New TechMates sold by BioTek in the Territories to New TechMates installed by DAKO. Furthermore, BioTek shall refrain from, directly or indirectly, selling reagents for use in the New TechMates sold in the Territories [*]. In the event that DAKO -13- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 14 sells reagents for such New TechMates, then DAKO shall pay royalties to BioTek as if such New TechMates had been sold by DAKO. Notwithstanding the foregoing provisions of this subparagraph, BioTek will have also satisfied such contemplated adequate sales threshold if BioTek demonstrates sales and market appeal by selling [*]. If BioTek does so, DAKO shall have no right to issue a "Sales Failure Notice" to BioTek. There is no default or failure under this Section if BioTek fails to install the New TechMate in the United States. Additionally, DAKO agrees that in its efforts to install the aforementioned [*], DAKO will not add a mark-up [*] the New TechMate Instrument transfer price. Should BioTek undertake sales of New TechMate Instruments under the six month provision mentioned above, BioTek will adhere to the same [*] on the New TechMate transfer price to DAKO in its efforts to achieve the [*]. 21g. Failure to Deliver. In the event that BioTek breaches its obligations under Section 4a hereof to ship Instruments and Accessories [*] of an order from DAKO, and if such breach is not cured by BioTek [*] by BioTek of written notice thereof from DAKO (the "Delivery Failure"), DAKO shall have the right to either (x) use the license granted under Subsection 22 below or (y) trigger the repayment of the Notes [*] in accordance with their respective terms. DAKO shall send written notice to BioTek of which of the above options it has elected on or before [*] after such Delivery Failure. BioTek agrees to maintain inventory access, either work in progress or finished Instruments, that may be shipped to DAKO within five (5) working days, equal to the monthly average number of Instruments installed by DAKO during the previous three calendar months and DAKO agrees to maintain the number of Instruments in inventory as provided at paragraph 3H of this Distribution Agreement. 21h. License to Develop New TechMate. (i) Grant of License. BioTek hereby grants to DAKO an exclusive license, and/or sublicense, as the case may be, under BioTek's Intellectual Property Rights as set forth at Schedule J hereto (the "Intellectual Property Rights") to complete the development of the New TechMate. Such license shall be in addition to, and not in lieu of, any other license granted under this Distribution Agreement. (ii) Term. The term of the license granted by this Subsection 21h shall commence automatically upon a Milestone Default. -14- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 15 (ii) Consultants. In the event that the license granted by this Section is exercised by DAKO, BioTek (if it is still operating) hereby agrees that it will use its best efforts to make available the employees (the "Consultants") listed on Schedule K hereto (or any subsequent schedule which is placed in escrow pursuant to the Escrow Agreement) to act as consultants to DAKO until such time as the development of the New TechMate is completed and DAKO agrees to reimburse BioTek for the allocable salary of each such consultant. BioTek considers the Consultants to include all of the employees and/or consultants which are integral to the development of the New TechMate. (iv) Assignment of Confidentiality Agreements. BioTek hereby assigns to DAKO, which assignment shall become effective upon the commencement of the term of the license granted by this Section, all of its right, title and interest in to and under each of the confidentiality agreements between it and each of the Consultants. 22. License to Manufacture the Instruments. 22a. Grant of License. BioTek hereby grants DAKO a non-exclusive, irrevocable, fully-paid license and/or sublicense, as the case may be, under the Intellectual Property Rights to manufacture, or cause the manufacture of, each of the TechMate 500, the TechMate 1000 and the New TechMate. Such license shall be in addition to, and not in lieu of, any other license granted under this Distribution Agreement. 22b. Term. The term of the license granted by this Section 22 shall automatically commence (i) with respect to the TechMate 500 and the TechMate 1000, upon a Delivery Failure of such Instruments; and (ii) with respect to the New TechMate, on the earlier of (x) the effectiveness of the license to develop the New TechMate granted under subsection 21 h or (y) a Delivery Failure of such Instruments. 22c. Instrument Prices. If DAKO utilizes the license granted by this subsection, DAKO shall pay to BioTek or its successors the full transfer price in effect at such time that DAKO begins using such license otherwise payable for each such Instrument hereunder, less the amount which DAKO must pay to any manufacturer with respect to such Instrument. The amount which must be paid to the manufacturer would be tendered directly by DAKO to such manufacturer; provided, however, that (i) if there is a cost reduction in the manufacturing price during any period when DAKO is contracting directly with the manufacturer, the benefits of any reduction in manufacturing cost shall be shared by BioTek and DAKO equally, or (ii) if there is a cost increase in the manufacturing price during any period when DAKO is contracting directly with the manufacturer, if BioTek shall locate a bone fide manufacturer on at least the same quality level as Kollsman Manufacturing and its sub-suppliers in either the United States or Europe which is willing to manufacture the Instrument for a lower price, then DAKO shall only be able to decrease the transfer price by such lower amounts. -15- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 16 22d. Royalties. For the TechMate 500 and the TechMate 1000, in the event of the circumstances described in this Subsection, the royalties described in this Agreement [*] of the amounts that would otherwise be due. For the New TechMate, in such circumstances, the royalties described in this Agreement will be [*] of the amounts that would otherwise be due as set forth above. In all other respects, except for the respective reductions set forth above in this Subsection, all such royalties will be due and payable as provided in this Agreement. 22e. Assignment. BioTek hereby assigns to DAKO, which assignment shall become effective upon the commencement of the term of the license granted by this Section, all of its right (but no obligations), title and interest in, to and under any oral or written agreements entered into by and between BioTek and any of its manufacturers and/or subsuppliers. BioTek's current subsuppliers are listed in Schedule M hereto. In connection with the licenses granted pursuant to Sections 21h and 22 hereof, BioTek is concurrently herewith delivering the written Agreement of Erie Scientific substantially in the form of Exhibit D hereto (the "Erie Agreement"). 22f. Escrow of Technical Materials. In order to facilitate the utilization of the licenses granted pursuant to Sections 21h and 22 hereof, BioTek is concurrently herewith placing in escrow for DAKO with an escrow selected by the parties (the "Escrow") copies of all Intellectual Property Rights and related technical materials necessary to produce the Instruments and finalize the development of the New TechMate and a list of BioTek's current subsuppliers (the "Technical Materials") and is delivering herewith an executed Escrow Agreement, which agreement will be in substantially the form attached hereto as Exhibit E. BioTek agrees to update the Technical Materials one time per each fiscal quarter until such time as such Technical Materials are released from such Escrow. 23. Grant of Security Interest. 23a. As security for the payment of the Development Note and the Kollsman Note (collectively, the "Notes"), BioTek hereby grants to DAKO a security interest in the assets described in Schedule L hereto (the "Collateral"). 23b. DAKO agrees to subordinate the security interest hereby created to any line of credit extended to BioTek for working capital purposes by any bank or commercial finance lender licensed by the State of California (the "Line of Credit"), provided, however, that such subordination shall be subject to the following terms and conditions: (i) The total principal amount of such Line of Credit [*]; (ii) [*] in the aggregate amount of such Line of Credit, the amount of each recoupment amount which otherwise must be paid -16- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 17 by BioTek to DAKO hereunder respecting the Development Prepayment and/or the Kollsman Prepayment shall be increased as follows:
Additional Recoupment Line of Credit Amount Amount --------------------- --------------------- $0 - $50,000 [*] $50,001 - $100,000 [*] $100,001 - $150,000 [*] $150,001 - $200,000 [*] $200,001 - $250,000 [*] $250,001 - $300,000 [*] $300,001 - $350,000 [*] $350,001 - $400,000 [*] $400,001 - $450,000 [*] $450,001 - $500,000 [*]
Once any such incremental recoupment amount is triggered as set forth above, it shall not be reduced in any, manner, until all amounts are paid under the Kollsman Note and/or the Development Note, as provided in this Agreement, except that if at any time such aggregate Line of Credit amount is reduced to zero, then the Additional Recoupment Amount shall simultaneously be reduced to zero. 23c. So long as BioTek is not in default under the Notes or this Agreement and no event has occurred which with the giving of notice or the lapse of time, or both, would constitute a default by BioTek under the Notes or this Agreement, BioTek shall have the right to sell, license, lease, or otherwise dispose of the Collateral, provided such sale, license, lease or other disposal is (i) done in the ordinary course of business of BioTek consistent with past practice, and (ii) does not in any way impair or infringe the rights of DAKO under the licenses granted pursuant to Section 21 h and 22 hereof. 23d. The security interest granted hereby to DAKO shall be automatically released and/or terminated by DAKO upon the payment in full by BioTek of the principal amount of each of the Notes and all accrued interest thereon. Upon the release of the security interest granted hereby, DAKO, on the written request of BioTek, will execute and deliver such proper instruments of release and satisfaction as may reasonably be requested to evidence such release, and any such instrument, when duly executed by and -17- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 18 duly recorded in the places where the financing statements are recorded, shall conclusively evidence the release of the security interest granted herein. 23e. Concurrently with the delivery of the Notes, BioTek will execute, file and/or record in the appropriate jurisdiction a UCC-1 Financing Statement covering the Collateral and naming the DAKO as secured party. BioTek will give, execute, file and/or record any further notice, financing statement, instrument, document or agreement that DAKO may reasonably consider necessary or desirable to create, preserve, continue, perfect or validate the security interest granted hereby or which DAKO may reasonably consider necessary or desirable to exercise or enforce its rights hereunder with respect to such security interest including, but not limited to, any necessary filings with the U.S. Patent and Trademark Office and the U.S. Copyright Office, provided, however, DAKO acknowledges that its security interest shall remain subordinate to those of BioTek's present Senior Secured Note Holders. 24. Audit Rights. Solely for purposes of ensuring compliance with the terms of this Agreement, each of the parties hereto grants the other party the right to have an independent auditor audit its books and ledgers subject to the following terms: (i) each audit will be at the electing party's own expense; (ii) such audit will be conducted at the non-electing party's premises by no more than two individuals of such of such independent auditor; (iii) the electing party shall give the other party at least 30 business days notice of its intent to have such audit conducted; and (iv) such audits may not be conducted more frequently than one time per fiscal quarter. 25. Representations and Warranties. 25a. Title. BioTek owns all right, title and interest in and to the Intellectual Property Rights. 25b. Licenses. Except for the cross-licenses granted to Fisher Scientific Company, the licenses granted to purchasers of the Instruments, and those licenses granted to DAKO hereunder, BioTek has not granted any rights, licenses or interest whatsoever in, under or to the Intellectual Property Rights. 25c. Secured Interests. Except for the security interests of the holders of BioTek's senior secured notes, the Intellectual Property Rights are free and clear of all liens, encumbrances, security interests and restrictions on transfer. 25d. Authority. BioTek has all necessary right, power and authority to enter into this Amendment and to grant the licenses with respect to the Intellectual Property Rights as contemplated by the Agreement. To the extent required, BioTek has obtained all necessary consents of shareholders or creditors in connection with such grant. -18- 19 25e. No Infringement. To the best of BioTek's knowledge, the Instruments do not infringe any patent, copyright, trademark, trade secret or other proprietary or contractual rights of any third party. 25f. Manufacture. To the best of BioTek's knowledge, the Intellectual Property Rights are sufficient to permit DAKO to manufacture and/or develop the Instruments as contemplated by Subsection 21 h and Section 22 hereof, in conjunction with the rights granted under the Erie Agreement; the Technical Materials held in the Escrow include all materials (including, but not limited, to source code) necessary for DAKO to complete the development of the New TechMate and arrange for the 25g. No Litigation. To the best of BioTek's knowledge, there are no actions, suits, investigations, claims or proceedings pending or threatened against BioTek or in any way relating to the Intellectual Property Rights. 25h. No Formal Contracts. BioTek currently has no formal written agreements with Kollsman Manufacturing or any of its other subsuppliers or subcontractors. 1.9 Schedules. (a) Schedule A is hereby amended by adding the following provisions to the end of such schedule: "New TechMate Transfer Price (1) The transfer price of the New TechMate shall be BioTek's unit [*]; provided, however, that in no event shall the transfer price be more [*]. (2) Notwithstanding the above, after the [*] following the market introduction for sales of the New TechMate, and so long as there is an outstanding balance on the Notes, and if the cost of manufacturing of the New TechMate increases compared to the cost price currently in effect at the [*] period and/or the cost of any improvements or enhancements to the New TechMate cause such increase in cost then the transfer price to DAKO shall be calculated as follows; provided, however, that in no event shall the transfer price be more than [*]: (i) Cost price up to [*] + (ii) [*] -19- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 20 + (iii) Cost price in [*], however, limited to increase in cost after the twelve months (see above). (3) Notwithstanding the above, in case DAKO wants any improvements or enhancements to the New TechMate, then the net additional cost price plus the [*] of such improvement and/or enhancement shall be added to the transfer price as calculated in accordance with (1) plus (2) above. (4) Notwithstanding the above, if at any time during the term of this Agreement BioTek shall sell the New TechMate (also if improved or enhanced) at a transfer price which is less than that currently in effect with respect to purchases by DAKO, BioTek hereby agrees that DAKO shall thereafter be entitled to such lower transfer price with respect to future purchases of the New TechMate." (a) Schedule B is hereby amended by substituting the sentence: "DAKO agrees to [*] per reagent tray for each tray provided by BioTek to DAKO" for the pre-existing sentence: "Reagent trays shall be provided in reasonable quantities by BioTek at no charge to DAKO." SECTION 2 EFFECTIVENESS OF AMENDMENT 2.1 Effective Date. This Amendment shall only become effective, and the parties obligations hereunder shall only arise upon the satisfactory completion of each and every one of the following conditions precedent: (a) BioTek shall have executed and delivered the Notes. (b) The parties shall have executed and delivered the Erie Agreement. (c) The parties and the Escrow Agent shall have executed and delivered the Escrow Agreement referred to herein and shall have placed the Technical Materials in trust with the Escrow Agent pursuant thereto. (d) BioTek shall have executed and delivered to DAKO the UCC-1 Financing Statement referred to in this Amendment and shall have made the appropriate filing with the U.S. Patent and Trademark Office and the U.S. Copyright Office. (e) Page Erickson and Steven Bernstein shall each have executed and delivered a certificate in substantially the form of Exhibit F hereto. -20- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 21 (f) The Certificate of Insurance described in Subsection 4f of the Agreement shall have been delivered. (g) BioTek's patent counsel shall have delivered patent information and assurances in form and substance reasonably satisfactory to DAKO's legal counsel. (h) BioTek shall deliver a Good Standing Certificate issued by the Secretary of State of the State of California certifying that BioTek was duly incorporated in the State of California and that it is in good standing in such State as of a date which is no later than two (2) days prior to the Effective Date together with a Certificate of the Franchise Tax Board of the State of California certifying that BioTek is in good standing with such agency as of a date which is no later than two (2) days prior to the Effective Date. (i) BioTek shall have delivered a copy of the form of Confidentiality Agreement which it utilizes for its employees and consultants. SECTION 3 MISCELLANEOUS 3.1 Capitalized Terms. All capitalized terms not otherwise defined herein shall be defined with reference to the original Agreement dated September 27, 1 994. 3.2 Counterparts. This Amendment may be executed in one or more counterparts, each of which shall be deemed an original for all purposes. 3.3 Full Force and Effect. Other than as expressly modified hereby, the Agreement remains unchanged and in full force and effect. 3.4 Severability. If any provision of this Agreement as amended hereby is held to be unenforceable, the remaining provisions shall, to the extent practicable, continue in full force and effect. The waiver of any breach or default shall not constitute a waiver of any other right hereunder or any subsequent breach or default. 3.5 Further Assurances. The parties agree to execute and deliver such further documents and instruments and shall take such other actions as may be reasonably required or appropriate to carry out the intent and purpose of this Amendment. -21- 22 IN WITNESS WHEREOF, the parties hereto have executed this First Amendment, effective as of the date upon which the last party to execute this document affixes his signature hereto. "BioTek" BioTek Solutions, Inc. a California corporation By: - --------------------------- -------------------------------------- Date Michael C. Miller, CEO (Signatures continue on following page.) -22- 23 "DAKO" DAKO A/S By: - --------------------------- -------------------------------------- Torben Jorgensen Managing Director By: - --------------------------- -------------------------------------- John F. Place MA Bus. Development Manager -23- 24 Schedule List Schedule G Royalties Schedule H Milestones Schedule I Description of New TechMate Project Schedule J Intellectual Property Rights Schedule K Consultants Schedule L Collateral Schedule M Subsuppliers Exhibit List Exhibit A Additional Amendments Exhibit B Kollsman Note Exhibit C Development Note Exhibit D Erie Agreement Exhibit E Escrow Agreement Exhibit F Scientist's Certificate -24- 25 Schedule G Royalties -25- 26 Schedule G TechMate 500 and TechMate 1000 Royalty Schedule
$ per month per Standard Royalty: instrument ------------------------------------ --------------- Installation to end of the calendar [*] month (installation month) First and second calendar months [*] Third and fourth calendar months [*] Fifth, sixth, seventh and eighth [*] calendar months Ninth, tenth, eleventh and twelfth [*] calendar months Thereafter [*]
Notwithstanding the terms of the above table of royalties, the following royalty terms shall apply for the following countries:
- ------------------------------------------------------------------------------------- UK FRANCE ITALY SWITZERLAND GERMANY SWEDEN - ------------------------------------------------------------------------------------- Installation month [*] [*] [*] [*] - ------------------------------------------------------------------------------------- First calendar month [*] [*] [*] [*] - ------------------------------------------------------------------------------------- 2, 3, 4 calendar month [*] [*] [*] [*] - ------------------------------------------------------------------------------------- 5, 6 calendar month [*] [*] [*] [*] - ------------------------------------------------------------------------------------- Thereafter [*] [*] [*] [*] - -------------------------------------------------------------------------------------
-26- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 27 Schedule H Milestones -27- 28 BioTek Solutions New System Development Plan The following is a description of the milestones as indicated in the New System Development Plan. The Milestone #'s correspond to the line item numbers in the Development Plan Outline.
Completion Milestone Activity Description Deliverables Date Funding Date/Budget - --------- ------------ -------------------------------------------- ----------------------------- ---------- ------------------- 1 (31-50) 2.1-3.6 System Design and Specification A. System Level Specification [*] [*] B. CAD 3-D System Model System level design and specification of all primary subsystems and industrial design of housing User Evaluation of system design via a working model. 2 (53-68) 4.1-4.9 Detailed Subsystem Design A. Detailed CAD part drawings [*] [*] B. Prelim. Assembly Drawings Detailed design, specification and C. Engineering BOM documentation of mechanical, electrical and D. Purchased Component Specs. electronic subsystems and components. E. Test Procedure Doc. Sourcing of purchased components. F. Hazard Analysis Preliminary software testing and hazard analysis. 3 (71-81) 4.10-4.13, & Evaluation Prototypes/Launch A. (3) Facsimile Prototypes [*] [*] 10.0 B. Performance est Results Production of prototype patterns and molds C. Product launch for facsimile molded plastic parts. Purchase D. Market Acclaim of components. Assembly and testing of (3) evaluation prototypes Clinical performance evaluation of prototype units against TechMate 500. 4 (84) 4.14 Production tooling Hard tooling for production units A. Hard Tooling [*] [*] B. Sample Parts
-28- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 29
Completion Milestone Activity Description Deliverables Date Funding Date/Budget - --------- -------- ---------------------------------- --------------------------- ---------- ------------------- 5 (115-120) 9 Pilot Production A. (15) Pilot Units [*] [*] B. Production Documentation Update to production documentation C. V&V Test Results D. Final Cost Roll-up Pilot unit fabrication and testing Pilot unit V&V testing Product launch. 6 (124-126) 11 Release to Production A. Documentation Transfer [*] [*] Transfer of final documentation to production vendors.
-29- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 30 Exhibit A Additional Amendments -30- EX-10.1(C) 4 FURTHER AMENDMENTS TO 1ST AMENDMENT TO DAKO 1 EXHIBIT 10.1C EXHIBIT 'A' NOW, THEREFORE, in consideration of the respective covenants of the parties herein set forth, the parties hereto agree as follows: 1. PRODUCTS 1a. The Products covered by this Agreement include (i) the instruments described in Schedule A manufactured by or for BioTek, including components and base software, and parts necessary for the maintenance and repair thereof (hereinafter "Instruments") (BioTek) accessories, components, buffers and supplies listed in Schedule B, manufactured by or for BioTek, (hereinafter "Accessories") and (iii) reagents listed in Schedule C, developed and/or in a formulation specifically intended or designed for use on instruments and manufactured by DAKO (hereinafter "Reagents"). Other reagents manufactured and sold by or for DAKO but not developed and/or in a formulation specifically intended or designed for use on instruments, may be used on instruments, and therefore may be used in payment calculations. Schedules A, B, and C may be updated and amended from time to time by mutual consent of the parties. 1b. BioTek shall make available to DAKO on an exclusive basis any improved or updated versions and any similar or related Instruments and/or Accessories under the same terms and conditions as set forth herein. Said updated and improved Instruments and/or Accessories shall be 2 included in Schedules A or B. DAKO shall include any improved or updated versions of Reagents in Schedule C. Any and all changes in product specifications shall be mutually agreed by the parties to this Agreement. 1c. For any period during which this Agreement is exclusive BioTek shall offer to DAKO in writing the right to distribute, during the term of this Agreement and on the same terms and conditions (other than price) as set forth herein, any new products developed by or for BioTek, and DAKO shall have the option to accept distribution rights with respect to said new products in writing [*] of BioTek's written notice to DAKO of the availability thereof. If DAKO decides not to exercise this option, BioTek may distribute, or enter into an Agreement to distribute with a third party, any such new product on terms that will also be offered to DAKO. Such terms to third parties may change over time through volume discounts, price increases etc., at the sole discretion of BioTek. 1d. BioTek shall ensure that spare parts and accessories necessary for the operation and repair of any Instruments delivered to customers under this Agreement shall be available for purchase by DAKO or any DAKO customer, at their expense, including but not limited to parts, shipment and installation expenses, in such circumstances that said parts are not covered by warranties provided through DAKO (or BioTek as agreed), for the term of this Agreement. A spare parts list is attached to this Agreement (Schedule P). -2- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 3 1e. All products promoted and sold under this Agreement shall be promoted and sold under dual label, wherein both DAKO and BioTek labels and trademarks are of equal size and character (see Schedule D). Some components for Reagents as well as buffers required to optimize the use of instruments will be manufactured by BioTek (see Schedule B). Incorporation of components and inclusion of buffers into Reagents, and final manufacturing of Reagents and quality control will be carried out by DAKO. 1f. DAKO and BioTek have signed a Confidentiality Agreement and will treat all knowledge gained through collaboration on dual label products as trade secrets for the term of this Agreement or any extensions to this Agreement plus a five (5) year period following the termination of this Agreement for any reason. 2. GRANT OF DISTRIBUTORSHIP 2a. Upon the terms and subject to the conditions hereinafter set forth, BioTek hereby appoints DAKO and DAKO accepts the appointment as the exclusive distributor of Instruments and Accessories in the Territory as of the effective date of this Agreement. Except as otherwise provided in sections 3a. (BioTek) or 3a (iii) below, BioTek reserves no right to distribute Instruments and Accessories in the Territory and DAKO shall have no rights under this Agreement to sell or distribute Instruments, Accessories or Reagents outside of the Territory unless mutually agreed upon by the parties. -3- 4 2b. The Territory in which DAKO has the rights described in section 2a. hereof to distribute the Instruments and Accessories shall be Europe, the Middle East, India and Africa (hereinafter "Territory"). DAKO and BioTek will enter into good faith negotiations concerning (a) similar Agreement(s) for Japan and South East Asia. 2c. With the exception of the conditions described in section 2d., for any period during which the arrangement between the parties for distribution of Instruments and Accessories is exclusive, DAKO shall not sell within the Territory any other automated immuno-histochemistry instrument which performs multiple functions, or any other stainer which is competitive being made available for inclusion in Schedule A (see section 1.b), and shall not sell within the Territory any other accessories, components, buffers and supplies which are directly competitive with the Accessories described in Schedule B hereto unless otherwise mutually agreed. 2d. Notwithstanding section 2c., and limited to Italy, in the case of tenders for sale of reagents in which said tender requires DAKO to offer instruments for sale as an integral part of the tender, DAKO shall inform BioTek of such tender offers prior to submission whereupon BioTek may offer alternative sales or product options to DAKO to accommodate such tender requirements, and if this does not allow BioTek's instrument to be sold through such tenders, then DAKO shall be allowed to sell other automated immunohistochemistry instruments as part of such tenders. -4- 5 2e. Unless otherwise specifically agreed to the contrary, during the term of the Agreement in which the arrangement between the parties for distribution of Instruments and Accessories is exclusive, BioTek shall not sell within the Territory any reagents which are specifically intended or designed for use with Instruments described in Schedule A and DAKO shall include in Schedule C any reagents which are specifically intended or designed for use with the Instruments described in Schedule A. DAKO , sell dual label Reagents for use on Instruments. 3. CONDUCT OF DAKO 3a. DAKO shall exclusively promote, distribute and sell Instruments and Accessories during the term of this Agreement, within contract periods ("Contract Periods") as are set forth below: The first Contract Period shall commence on the date of installation at a customer location of the first Instrument in the Territory and last until 30th June 1995. Subsequent Contract Periods shall be twelve month periods beginning on the 1st July of each calendar year.
CONTRACT PERIOD NUMBER OF INSTRUMENTS PER CONTRACT PERIOD CUMULATIVE Until July 1, 1995 [*] Year 2 [*] [*] Year 3 [*] [*]
-5- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 6 (i) The foregoing shall constitute volume targets under which the continuation of this Agreement shall be determined. DAKO shall be considered to have achieved such target if the sum of total of Instruments placed within the Territory plus firm orders to deliver, equals or exceeds the cumulative number of Instruments given above at the end of a Contract Period. (ii) Should DAKO not achieve a cumulative target, BioTek shall have the option, within thirty (30) days thereof, as its sole and exclusive remedy for failure to achieve the target, give DAKO thirty (30) days written notice of its intention to sell the Instruments and Accessories in the Territory, either directly or through third parties, as long as sales price is not less that the Transfer Prices shown in Schedules A and B. If BioTek exercises such option, DAKO may; continue to distribute Instruments and Accessories on a non-exclusive basis; or DAKO may place guaranteed Purchase Orders to make up the shortfall in sales of Instruments so long as delivery for such Instruments is within ninety (90) days; in which case BioTek shall withdraw said notice; or, DAKO may elect to terminate the Agreement by providing thirty (30) days prior written notice to BioTek within thirty (30) days of receipt of said notice. Such termination shall be without liability to either party, except for such other liabilities as may otherwise specifically be set forth in this Agreement or under Law. (iii) Should DAKO not achieve a cumulative target, DAKO shall have the option, within thirty (30) day thereof, to give BioTek thirty (30) days written notice of its intention to continue to distribute Instruments and Accessories on a non-exclusive basis, or DAKO may elect to terminate the Agreement by giving ninety (90) days written notice to BioTek. Such termination shall be without -6- 7 liability to either party, except for such other liabilities as may otherwise specifically be set forth in this Agreement or under Law. (iv) Notwithstanding the foregoing, if DAKO is not able to achieve the target in any Contract Period due to an act or omission of BioTek or due to any event(s) which are beyond its reasonable control (e.g. section 11), such inability shall not constitute grounds for BioTek to exercise the option to sell Instruments and Accessories in the Territory, as aforesaid in section (BioTek). In the event that DAKO is unable to achieve the target for any Contract Period due to failure of BioTek to deliver the quantities of Instruments required to achieve the target, the target shall be deemed to have been met for that Contract Period and the cumulative numbers for subsequent Contract Periods shall be adjusted downwards by the difference between the target and the numbers of Instruments delivered. (v) Notwithstanding the foregoing, if at any time after 1st January 1996, a technological development occurs which substantially reduces the market for Instruments, DAKO shall have the option to give [*] notice to BioTek of its intention to continue to distribute Instruments and Accessories on a non-exclusive basis for a [*] and may thereafter terminate this Agreement. Such notice shall be accompanied by evidence of substantial fall in Instrument placements. In these circumstances, BioTek reserves the right to give similar notice as to non-exclusivity and/or termination should such technological changes adversely effect the on-going business of BioTek as deemed solely by BioTek. -7- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 8 3b. DAKO shall order Instruments and Accessories hereunder by submitting firm purchase orders to BioTek. Such firm purchase orders shall be given on DAKO's purchase order form and shall be acknowledged by BioTek by facsimile within two (2) working days. 3c. In conjunction with this Agreement, DAKO has issued to BioTek firm purchase orders for [*], which shall be delivered by BioTek in accordance with the provisions of section 4a. of this Agreement. 3d. DAKO may return for full credit or replacement, any Instrument or Accessory for which DAKO is required to give a customer credit or replacement Instruments or Accessories due to a defect or deficiency in the Instrument or Accessory, provided that DAKO first gives BioTek the option of repairing such Instrument on site, either through its own personnel or through the direction of DAKO personnel or contractors, with on site time and parts expenses assumed by BioTek and only then, if DAKO obtains from BioTek a returned goods authorization, which shall not be unreasonably withheld or delayed by BioTek. 3e. DAKO agrees to mark Reagents (Schedule C) at the lowest saleable unit and on all packaging and inserts with BioTek's trademarks in a firm and size to be mutually agreed by both parties. Such marking shall be fully described in Schedule D which schedule shall be updated from time to time. 3f. DAKO agrees to bar-code Reagents at the lowest saleable unit using symbology 3 to 9 in accordance with Health Industry Bar Code ("HIBC"). -8- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 9 3g. DAKO shall pay to BioTek a royalty based on TechMate 500 and TechMate 1000 Instruments that are sold and delivered to DAKO or delivered to DAKO's customers based on DAKO's drop shipment directions. Such royalty shall be paid to BioTek by DAKO for each Instrument installed by DAKO [*]. However, if DAKO requests by [*] next generation instrument and if BioTek by [*] cannot demonstrate a capability to deliver such an instrument by the [*], such royalty shall be paid to BioTek by DAKO for a period [*]. Such royalties per Instrument purchased shall be paid on a monthly basis on the first day of each calendar month, starting on the first installation date of the instrument as follows:
$ per month per instrument Installation to end of the calendar month (installation month) [*] First and second calendar months [*] Third and fourth calendar months [*] Fifth, sixth, seventh and eighth calendar months [*] Ninth, tenth, eleventh and twelfth calendar months [*] Thereafter [*]
Notwithstanding the above, such royalty shall not be paid for Instruments sold to Pharmaceutical companies that purchase limited amounts of dual-labeled Reagents from DAKO, but DAKO shall pay instead a [*] sold by DAKO for use on such Instruments. -9- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 10 In relation to the payment of these royalty fees, BioTek reserves the right and DAKO grants the right to BioTek to appoint an independent auditor to audit the accounts of DAKO quarterly, at BioTek's expense. 3h. DAKO shall maintain in its inventory at least such number of Instruments as may be equal to the monthly average number of Instruments installed during the [*]. DAKO will not be charged monthly royalty fees (according to section 3g) on these inventory Instruments until such time as they leave inventory and are installed at customer sites. 3i. DAKO shall at its own cost and expense provide appropriate personnel, Instruments, Accessories and Reagents to prospective customers identified by DAKO for conducting performance studies and product evaluations as may be reasonably requested by qualified prospective customers. 3j. DAKO will maintain at its own cost and expense, technical and sales support in the form of full-time sales personnel and other dedicated applications specialists as required at DAKO locations, for example in Milan and Paris. [*] -10- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 11 [*] 3k. DAKO shall establish at two separate locations, stocks of materials and Reagents (hereinafter "Reagent Stock") as a buffer against changes in supply conditions of Reagents. Each Reagent Stock shall contain materials and finished Reagent products equivalent to the requirements for at least placements of Instruments. 3l. If DAKO for some reason is unable to continue production and maintain Reagent Stock levels, DAKO shall inform BioTek and promptly enter into agreement with an alternative supplier (with first option to supply offered to BioTek) to obtain the necessary materials and products to maintain such Reagent Stocks. Should DAKO not be able to ensure such supply, BioTek shall have the option to supply directly or indirectly such Reagent materials and products at the prices currently in effect with customers at the time DAKO ceases supply and until DAKO can resume such supply, and negotiate on a good faith basis with DAKO for payment for such supplies. 3m. BioTek will provide [*] for DAKO to place into prestigious, reference laboratories where DAKO and BioTek both agree there is a potential to generate significant other placements. These laboratories are [*] -11- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 12 [*] DAKO shall purchase said Instruments according to section 3b, BioTek agrees to provide these [*] at a billed rate of [*] 3n. DAKO will provide BioTek with rolling forecasts of monthly Instrument requirements for twelve month intervals. These forecasts will be provided quarterly. The first forecast will be provided for the interval starting 1st January 1995. These forecasts shall be planning purposes only and shall not constitute a purchase order. Further DAKO will provide quarterly rolling forecasts for each quarter, based on the last two months of the preceding quarter actual orders plus twenty five percent (25%). Such quarterly forecasts will be provided 45 days in advance of the start of a quarter. DAKO will issue firm Purchase Orders at least once a month based on the above quarterly rolling forecasts. DAKO will provide by the end of each quarter rolling forecasts by quarter of the forecasted requirement of instruments for the next four quarters. Once introduced the forecasted number of instruments for a particular quarter may be changed with each new quarterly forecast by maximum 20%. The number of instruments forecasted for the quarter immediately following the date of the forecast shall be ordered by DAKO in the form of a firm Purchase Order 3o. BioTek together with DAKO shall make a weekly update of a Distribution Plan that details -12- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 13 for each instrument ordered; destination, requested ship date, projected installation date, and firm ship date. 4. CONDUCT OF BIOTEK 4a. BioTek shall ship promptly, but in any event [*] from confirmation of order, DAKO's orders for Instruments and Accessories. All orders shall be shipped f.c.a. Boston Airport (or f.o.b. Port of Boston, or such location(s) as appropriate) at which point title and risk of loss shall pass from BioTek to DAKO, freight and insurance prepaid to such location(s) as DAKO may designate. BioTek shall cooperate with DAKO in limiting drop shipments of Instruments and Accessories to DAKO to an absolute minimum. 4b. In addition to the shipments mentioned above in section 4a., BioTek shall ship to DAKO in Copenhagen by December 31, 1994, [*] 4c. [ * ] 4d. BioTek shall notify DAKO immediately in writing should BioTek become aware of any defect or condition which renders any Instrument or Accessory in violation of any statute or regulation, or which in any way alters the specifications or quality of the Instrument or Accessory. -13- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 14 4e. BioTek shall execute and abide by the terms of BioTek's Continuing Guaranty (see Schedule E) incorporated herein by reference, with respect to Instruments and Accessories and DAKO shall abide by the its General Terms and Conditions of with respect to Reagents. The terms and conditions of the Continuing Guaranty and the General Terms and Conditions of Sale shall survive the termination of this Agreement. 4f. BioTek shall provide DAKO with a Certificate of Insurance which meets the requirements of section D of the Continuing Guaranty on or prior to execution of this Agreement. BioTek shall provide DAKO with renewal insurance certificates in the form mandated by section D of the Continuing Guaranty during the term of this Agreement, without demand therefore by DAKO. Notwithstanding any provision of the Continuing Guaranty to the contrary, the amount of the insurance required of BioTek pursuant to the Continuing Guaranty during the first Contract Period shall [*]; for the next subsequent Contract Period [*]; for all subsequent Contract Periods of the term of this Agreement [*]. 4g. BioTek shall provide to DAKO's Sales personnel, at Santa Barbara or at a location chosen by BioTek, training in the use, technical properties, sale competitive features and benefits of Instruments and Accessories as may be reasonably requested from time to time by DAKO. For purposes of such training, [*] -14- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 15 4g.(i) BioTek will provide Instrument and Accessory sales materials that will be revised only to reflect necessary changes in language. It is clearly understood by the parties that BioTek's Agreement must be confirmed in writing before any changes are made to BioTek marketing materials or before the size, graphic design, legend(s) trademark or logo of BioTek is altered, redesigned or used in any way. In general, literature will be under DAKO's corporate identity and conform with DAKO's current offerings, but will include the BioTek name and trademark in similar size and character in all dual labeling (see Schedule D). 4h. BioTek shall provide technical support to DAKO's sales personnel at sites to be determined by BioTek, and promptly provide to DAKO such additional types and quantities of technical information developed or acquired by BioTek from time to time as may reasonably be expected to be of assistance to DAKO in fulfilling its obligations hereunder. In particular BioTek shall provide technical training for DAKO's and DAKO Service Partner's field service engineers in the installation and repair of TechMate instruments. 4i. BioTek shall supply at its expense reasonable quantities of such instruction and training manuals and point of sale literature as may from time to time be requested by DAKO for use in connection with the distribution and sale of Instruments in the Territory. Subject to DAKO's prior written approval, the DAKO name will be incorporated into BioTek's advertising literature for Instruments and Accessories intended for distribution by DAKO. If requested to do so by DAKO, BioTek shall furnish DAKO with suitable copy and photographs for use by DAKO in cataloguing the Instrument and Accessories. -15- 16 4j. Any Instrument or Accessories owned by DAKO and rendered unsaleable due to change in any product specification, discontinuation or elimination by BioTek of any product from its product offering, release by BioTek of any improved or updated version of any Instrument or Accessory, shall be repurchased from DAKO by BioTek [*] following DAKO's written request therefore, at the price paid for such product by DAKO. BioTek shall additionally pay for return freight and related transportation and insurance charges for all such products. 4k. BioTek agrees to mark Instruments and Accessories (Schedules A and B) at the lowest saleable unit and on all packaging and inserts with DAKO's trademarks in a form and size to be mutually agreed by both parties. 4l. BioTek agrees to bar-code Accessories at the lowest saleable unit using symbology 3 to 9 in accordance with Health Bar Code ("HIBC"). 4m. BioTek shall notify DAKO (and DAKO shall notify BioTek) in writing of any special requirements determined for the storage and handling of Instruments or Accessories and any laws, regulations, orders, ordinances and requirements of all local state and country governments and agencies having jurisdictions over these products. 4n. BioTek shall supply DAKO qualified leads which may come to its attention for sales or placements of Instruments in the Territory. -16- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 17 4o. Upon execution of this Agreement, BioTek shall provide DAKO with all necessary and appropriate information concerning all of BioTek's existing or prospective customers in the Territory, which customers shall thereafter be the customers of DAKO. BioTek shall cooperate with DAKO in notifying said customers of the appointment of DAKO as BioTek's exclusive distributor of Instruments and Accessories in the Territory and with the orderly transition of such customer accounts to DAKO. Additionally, DAKO and BioTek agree to formulate and release press and other public statements that serve to promote the announcement of their relationship and any other noteworthy events that may serve the mutual benefit of the parties. Content and copy will be mutually agreed upon by the parties. 4p. Each quarter during the first Contract Period and semi-annually thereafter, BioTek's Executive Management shall meet with DAKO's Executive Management for general business review discussions on site at BioTek or at DAKO A/S or at a DAKO subsidiary site, and mutually agreed in advance of such meetings. 4q. BioTek shall maintain adequate inventories so as to supply to DAKO, stocks of materials and Accessories as a buffer against changes in supply conditions of Accessories (hereinafter "Accessory Stock"). Each Accessory Stock shall contain materials and finished Accessory products equivalent to the requirement for [*] of operation of the existing placements of Instruments. 4r. If BioTek for some reason is unable to continue production and otherwise maintain the Accessory Stock levels mentioned in section 4q. above, BioTek shall inform DAKO and promptly -17- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 18 enter into agreement with an alternative supplier (with first option to supply offered to DAKO) to obtain the necessary materials and products to maintain such Accessory Stocks. Should BioTek not be able to ensure such supply, DAKO shall have the option to supply directly or indirectly such accessories at the prices currently in effect with customers at the time BioTek ceases supply and until BioTek can resume such supply, and negotiate on a good faith basis with BioTek for payment for such supplies. 5. PRICE AND PAYMENT TERMS 5a. BioTek shall supply and ship Instruments to DAKO at the prices shown in Schedules A hereto for the duration of the Agreement 5b. BioTek shall give at least thirty (30) days prior written notice of increase in price of any accessory and honour DAKO's purchase orders at the prices at the time the purchase is made, notwithstanding during the delivery dates. The transfer prices given in Schedule B shall only be changed as a result of a change in the cost to BioTek. BioTek shall not add to such cost to BioTek a margin greater than 20% (twenty per cent) of such cost. -18- 19 relation to any such changes in price, DAKO reserves the right and BioTek grants the right to DAKO to appoint an independent auditor to audit the accounts of BioTek at DAKO's expense. 5c. BioTek agrees to negotiate with DAKO any special discounted transfer pricing: (i) on any large quantity order for instruments and/or Accessories which may be requested by any DAKO customer, (BioTek) where required to meet competition. In such cases of discounted transfer pricing, BioTek shall pre-approve in writing (in such format as the parties may mutually agree) any reduction in the attached schedules A or B discounted transfer prices as may be required. Notice of acceptance or rejection of each such request for pre-approval shall be communicated by BioTek to DAKO promptly following DAKO's request therefore. 5d. Payment for delivered Instruments and Accessories shall be made within current month plus [*] the date of delivery by BioTek during the first Contract Period and within current month plus [*] from the date of delivery in all subsequent Contract Periods. 5e. DAKO shall be entitled to resell Instruments and Accessories intended for resale on such terms as it may, at its sole discretion, determine, including without limitation, price, returns, credit and discounts. 5f. DAKO shall exclusively promote all products listed in Schedule B including slides, pads and software. DAKO will include such products in reagent rental and reagent contracts, and will offer these products on substantially the same terms and conditions as products manufactured by DAKO. -19- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 20 5g. All sums due under this Agreement shall be made in United States Dollars by wire transfer and BioTek shall pay any transfer fee. 6. TERM AND TERMINATION 6a. The initial term of this Agreement shall be for a period of five (5) years starting from 27th September 1994. After said initial term, this Agreement shall terminate, unless renewed by mutual Agreement between DAKO and BioTek for additional and successive terms [*]. 6b. This Agreement shall terminate immediately upon written notice by the non-breaching party if either party (i) commits or suffers an act of bankruptcy or insolvency or, except as otherwise provided in this Agreement, (BioTek) fails to cure any material breach in the provisions of this Agreement [*] after receipt of written notice of such breach. 6c. On the termination or non-renewal of this Agreement, howsoever arising, BioTek shall continue to honour DAKO's purchase orders for Instruments and Accessories up to the effective date of termination or non-renewal. 6d. The rights and duties of each party under this Agreement and the schedules hereto in respect of performance prior to termination or non-renewal shall survive and be enforceable in accordance with the terms of this Agreement. -20- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 21 6e. Upon termination or non-renewal of this Agreement BioTek shall repurchase from DAKO at DAKO's request, and at DAKO's cost therefor, such unsold Instruments and Accessories as are then owned by DAKO. Delivery of Instruments and Accessories repurchased from DAKO hereunder shall be f.c.a. DAKO's premises. 7. RIGHT OF FIRST REFUSAL 7a. If BioTek negotiates a transaction which would result in the sale by BioTek of all or substantially all of its business or its stock or assets, BioTek shall give written notice of such intention to DAKO, which shall have the option, first, after Curtin Matheson Scientific Inc., USA ("CMS") to enter into good faith negotiations for the purchase of BioTek. If CMS and BioTek are unable in good faith to agree on terms for sale [*] the notice given by BioTek of such sale, or if CMS declines to purchase before terms are agreed, DAKO shall have the right to negotiate in good faith with BioTek to try to agree upon mutually satisfactory terms for said sale. If DAKO and BioTek are unable in good faith to agree on mutually satisfactory terms for the proposed sale within a period of [*] of negotiation or if prior to expiration of said [*] period DAKO declines to purchase, then BioTek shall have the right to enter into such a transaction with any third party upon such terms and conditions as may be agreed by BioTek and any such third party. If CMS or such third party purchase all or substantially all of the business, stocks or assets of BioTek, the purchaser shall assume all of the rights and obligations of this Agreement with respect to the parties to this Agreement. -21- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 22 8. WARRANTIES 8a. In addition to the warranties set forth in this Agreement and in the Continuing Guaranties which are attached hereto as Schedule E, BioTek and DAKO warrant that each of the products will conform to specifications set forth in the product literature prepared respectively by or on behalf of BioTek or DAKO and that said products will comply and be manufactured, packaged, sterilized (if applicable), labeled and shipped in compliance with all applicable Federal, state and local laws, orders, regulations and standards. In particular BioTek shall ensure that Instruments conform to EU instrument specifications and shall issue any necessary certification to this effect. 8b. BioTek represents and warrants that Instruments and Accessories supplied to DAKO under this Agreement shall not infringe upon the patients or proprietary rights of any third party. To the extent that any third party owns any patents or proprietary rights relating to Instruments or Accessories or to their manufacture, BioTek represents and warrants that it has obtained valid license rights from such third party to manufacture and sell Instruments and/or Accessories. Similarly DAKO warrants that Reagents manufactured by DAKO under this Agreement shall not infringe upon the patents or proprietary rights of BioTek or any third party. To the extent that any third party owns any patents or proprietary rights relating to Reagents or to their manufacture, DAKO represents and warrants that it has obtained valid license rights from such third party to manufacture and sell Reagents. -22- 23 8c. BioTek shall extend to DAKO customers its Suppliers' Warranties for Instruments and Accessories which are set forth in Schedule F. BioTek shall not modify any product Warranty without notifying DAKO with at [*]. BioTek warrants and represents that the products will perform in accordance with, and that BioTek shall strictly comply with, the terms of BioTek's product Warranties. DAKO's warranty for Reagents is included under the General Terms and Conditions of Sale (Schedule E). 9. TRADEMARKS 9a. BioTek hereby grants to DAKO the royalty-free right to use the trademarks: BioTek; TechMate; and ChemMate (see also Schedule D), on dual-labeled Reagents during the term of this Agreement within the Territory, it being expressly understood that DAKO shall discontinue the use of such trademarks upon termination of this Agreement (except in connection with the distribution and sale of DAKO's remaining inventory of Reagents or of Instruments or of Accessories in the event that DAKO does not elect to exercise its rights under section 6e hereof) and disclaim any rights in the trademarks other than the said licence. 9b. DAKO hereby grants to BioTek the royalty-free right to use DAKO's trademarks on Instruments and Accessories within the Territory and during the term of this Agreement, it being expressly understood that BioTek shall discontinue the use of such trademarks upon termination of this Agreement and disclaim any rights in the trademarks other than the said licence. -23- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 24 9c. BioTek recognizes that DAKO is the owner of the trademarks and tradenames denoting DAKO or DAKO products which DAKO may elect to use in the promotion and sale of Instruments and Accessories and that BioTek has no right or interest in such trademarks or tradenames. Similarly, DAKO recognizes that BioTek is the owner of the trademarks and tradenames denoting BioTek or BioTek products which BioTek may elect to use in the promotion and sale of products and that DAKO has no right or interest in such trademarks or tradenames. 10. CONFIDENTIALITY 10a. Each party acknowledges the confidential nature of information that may be disclosed hereunder (including but not limited to names of customers and other marketing-related information) and agrees to retain such information in confidence. This provision shall survive the termination of this Agreement for a period of three (3) years. Confidential information (especially technical information) may also be the subject of separate confidentiality agreements which the parties enter into. 11. FORCE MAJEURE 11a. The obligations of either party to perform under this Agreement shall be excused during each period of delay caused by such matters as strikes, shortages of power of raw material, government orders or acts of God, which are reasonably beyond the control of the party obligated to perform. The affected party shall make best efforts to remedy the effects of such Force Majeure. Any Force -24- 25 Majeure event shall not excuse performance by the party, but shall delay performance, unless such Force Majeure continues for a period in excess [*]. In such event, the party seeking performance may cancel its obligations hereunder. 12. NOTICES 12a. Any notice required by this Agreement shall be deemed sufficient if sent by certified mail, postage prepaid, to the party to be notified at the address set forth in the initial section of this Agreement until notice of a different address is supplied and if receipt is acknowledged by the receiving party. 12b. The parties to this Agreement shall give notification of any technical problems or delays, or of any production difficulties of significance. Such notice shall be given by facsimile with documentation and estimates of expected recovery time. 13. ENTIRE AGREEMENT 13a. This Agreement including the Schedules hereto, constitutes the entire Agreement between the parties relating to the subject matter hereof and supersedes all prior agreements and understandings, whether written or oral, between the parties with respect to such subject matter. In ordering and delivery of products, the parties may employ their standard forms, but nothing in these forms shall be construed to modify or amend the terms of this Agreement. -25- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 26 14. APPLICABLE LAW 14a. This Agreement shall be governed by the laws of the State of California. In the event of a dispute arising in any manner out of or in relation to this Agreement, the parties shall attempt in good faith to amicably resolve such dispute. Any disputes which cannot be amicably resolved shall be referred by one party for resolution by arbitration according to the rules of the International Chamber of Commerce. The language of arbitration shall e English and arbitration shall take place at a place determined by the non-referring party. 15. ASSIGNMENT AND SUCCESSION 15a. Except as provided in section 7a, This Agreement shall not be assigned or transferred by BioTek either voluntarily or by operation by law without the prior written consent of DAKO. 15b. This Agreement shall inure to the benefit of and be binding upon the parties hereto and their permitted successors and assigns. 16. AMENDMENTS 16a. No amendment or modification of the terms of this Agreement shall be binding on either party, unless reduced to writing and signed by an authorized officer of the party to be bound. -26- 27 16b. BioTek and DAKO will enter into a Development Agreement that will set forth the terms and conditions under which the work by developing new Reagents and Accessories shall be defined. Said Agreement will become an integral part of the present Agreement when it is agreed in writing by both BioTek and DAKO. DAKO will facilitate a meeting of representatives of BioTek, DAKO and appropriate DAKO subsidiaries to discuss, develop and execute said Development Agreement. 17. EXISTING OBLIGATIONS 17a. Each party represents and warrants that the terms of this Agreement do not violate any existing obligations or contracts of such party. Each party shall defend, indemnify and hold harmless the other party from and against any and all claims, demands, liabilities and causes of action which are hereafter made or brought against such other party which allege any such violation. 18. RELATIONSHIP OF THE PARTIES 18a. Nothing herein contained shall be deemed to be or construed as constituting either party as the agent or partner of the other. 19. COUNTERPARTS 19a. This Agreement may be executed in one or more counterparts, each of which shall be deemed an original for all purposes. -27- 28 IN WITNESS WHEREOF, the parties have by their duly authorized officers, executed this Agreement on the dates set forth below. FOR BIOTEK SOLUTIONS INC. - ----------------------------- Michael C. Miller President and CEO FOR DAKO A/S - ----------------------------- ---------------------------- Torben Jorgensen John F. Place MA Managing Director Business Development Manager -28- 29 SCHEDULE A: INSTRUMENTS TECHMATE 500 includes 386SX PC computer (486 Diamond Flower DFI) with colour monitor and mouse, BioTek basis system software, 3 slide holders, uninterruptable power supply and multiplug panel, free Warranty service (including parts and cure of any manufacturing defect) for a period of one year from the date of installation, user manual, service manual. TRANSFER PRICE [*] (See also section 6a) TECHMATE 1000 includes 386SX PC computer (486 Diamond Flower DFI) with colour monitor and mouse, BioTek basic system software, 3 slide holders, uninterrutpable power supply and multiplug panel, free Warranty service (including parts and cure of any manufacturing defect) for a period of one year from the date of installation, user manual, service manual. TRANSFER PRICE [*] (See also section 5a) -29- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 30 Hybridization Oven (available on or after 1st July 1995) Schedule B: ACCESSORIES (Updated December 1994)
TRANSFER PRICE 75/100um Slides (per 72) [*] 130/150um Slides (per 72) [*] Pads (per 50) [*] Software upgrade per year [*] Hematoxylin (350 ml) [*] Chromgens: Alkaline phosphaltase [*] DAB [*]
Reagent trays The following buffers shall be provided in bulk, in reasonable quantities sufficient for DAKO to prepare the kits and Reagents, at no charge to DAKO: Buffers SDK 1, 2 and 3 Water wash Microwaving buffer MWB101 Hydrogen peroxide blocking reagent -30- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. EX-10.3 5 CURIN MATHESON SCIENTIFIC DISTRIBUTION AGREEMENT 1 EXHIBIT 10.3 CURTIN MATHESON SCIENTIFIC, INC. DISTRIBUTION AGREEMENT THIS AGREEMENT, made and entered into on this 18th day of January, 1993 in Houston, Texas, by and between BioTek Solutions, Inc., 120 B Cremona Drive, Santa Barbara, California 93117, a corporation organized under the laws of the state of California, hereinafter referred to as "Supplier", and Curtin Matheson Scientific, Inc., 9999 Veterans Memorial Drive, Houston, Texas 77038, a corporation organized under the laws of the state of Delaware, hereinafter referred to as "CMS". WITNESSETH WHEREAS, Supplier desires to sell and/or market its products, and CMS desires to purchase and promote Supplier's products for resale to customers; and WHEREAS, the parties desire to enter into a distributorship agreement governing the terms of their relationship. NOW, THEREFORE, in consideration of the respective covenants of the parties herein set forth, the parties hereto agree as follows: 1. Products. a. The Products covered by this Agreement include that certain instrument described in Schedule A, manufactured by or for the Supplier, including accessories and parts and components necessary for the maintenance and repair thereof (hereinafter the "Instrument") and those reagents, controls, primary antibodies and accessories manufactured or produced by or for the Supplier as described at Schedule B (hereinafter collectively referred to as the "Reagents"). Schedules A and B may be amended from time to time by mutual consent of the parties. b. Supplier shall make available to CMS any improved or updated versions and any similar or related Products under the same terms and conditions as set forth herein. c. For any period during which the arrangement between the parties for distribution of the Products, as hereinafter defined, is exclusive, Supplier shall offer to CMS in writing the right to distribute any new products developed by Supplier during the term of this Agreement on the same terms and conditions (other than price) as set forth herein, and CMS shall accept distribution rights with respect to new products, if at all, in writing, within sixty (60) days of Supplier's written notice to CMS of the availability thereof; in the event CMS elects not to exercise such right within such period, Supplier may distribute any new products described in Supplier's notice to third parties on terms no more favorable than those offered to CMS. d. The Instrument set forth on Schedule A and any improved or updated versions thereof, the Reagents set forth on Schedule B and any improved or updated versions thereof and any 2 additional products accepted for distribution under Sections 1.b. and l.c. shall hereinafter collectively be referred to as the "Products". e. Supplier represents and warrants that all Reagents with a limited shelf life are reflected on Schedule B with the useful life of each Reagent stated in months from the date of manufacture. f. Supplier shall ensure that spare parts necessary for the operation and repair of any Instrument furnished hereunder shall be available for purchase by CMS's customers for a period of five (5) years after date of delivery of the Instrument in question to CMS's customers. g. Supplier agrees to and shall provide required Material Safety Data Sheets for any Reagent containing hazardous chemicals as required by Federal, state or local law. 2. Grant of distributorship. a. Upon the terms and subject to the conditions hereinafter set forth, Supplier hereby appoints CMS and CMS accepts the appointment as the exclusive distributor of the Products in the Territory during the term of this Agreement. Except as otherwise provided in Section 3.a.(ii), Supplier reserves no right to sell and distribute Products in the Territory, and CMS shall have no right to sell or distribute Products outside of the Territory. b. The Territory in which CMS has the rights described in Section 2.a. hereof to distribute the Products shall be the fifty (50) United States of America its territories and possessions. c. For any period during which the arrangement between the parties for distribution of Products is exclusive, CMS shall not sell any automated immunohistochemistry instrument which performs multiple functions and which is directly competitive with the instrument described on Schedule A hereto or any reagents or controls which are intended for use in connection therewith. 3. Conduct of CMS. a. CMS shall make good faith commercial efforts to promote, distribute and sell the Products during the term. Specifically, CMS shall make good faith commercial efforts to purchase from Supplier such number of Instruments within such contract periods (the "Contract Period(s)") as are set forth below:
Contract Period (in months from date of Estimated number of Instruments to be execution of this Agreement) (any purchased by CMS from Supplier partial calendar month shall be month 1) - ----------------------------------------------------------------------------------- 1 through 15 [*] - ----------------------------------------------------------------------------------- 16 through 27 [*] - -----------------------------------------------------------------------------------
-2- 3 28 through 39 [*] - ----------------------------------------------------------------------------------- 40 through 51 [*] - ----------------------------------------------------------------------------------- 52 through 63 [*] - -----------------------------------------------------------------------------------
(i) The foregoing shall constitute non-binding targets. CMS will be considered to have achieved each such target if it purchases from Supplier [*] in each of the respective Contract Periods. For purposes of this Section 3.a.(i), an Instrument shall be deemed purchased when a firm purchase order has been received by Supplier from CMS. (ii) Should CMS fail to purchase [*] of the term of this Agreement, Supplier may, within thirty (30) days thereof, as its sole and exclusive remedy for CMS's failure to purchase the targeted number of Instruments, give CMS sixty (60) days prior written notice of its intention to sell the Products in the Territory, either directly or through third parties provided that the terms of sale are no more favorable than those available to CMS. If Supplier exercises such option within the period of time set forth above, CMS may either continue to distribute the Products on a non-exclusive basis or may elect to terminate the Agreement by providing thirty (30) days prior written notice to Supplier within thirty (30) days of receipt of Supplier's notice to CMS. Such termination shall be without liability to either party, except for such other liabilities as may otherwise specifically be set forth in this Agreement or under law. (iii) Notwithstanding the foregoing, if CMS is unable to purchase the required number of Instruments in any Contract Period due to an act or omission of Supplier or due to any event or events which are beyond its reasonable control (as per paragraph 11), such failure shall not constitute grounds for Supplier to sell the Products in the Territory, as aforesaid. In the event that CMS is unable to meet its targeted Instrument purchases for any Contract Period due to the failure of Supplier to deliver the quantities of the Instruments required to meet such targeted levels after Supplier's receipt of firm purchase orders, CMS's obligation to meet such minimum will be deemed to have been met. In the event that CMS is unable to meet its targeted Instrument purchases [*] Contract Periods due to Supplier's failure to deliver the quantities of Instruments required to meet such targets, Supplier agrees to enter into good faith negotiations to establish new targeted Instrument purchase requirements that Supplier has the ability to supply. (iv) In the event Supplier and CMS are unable to agree on new targeted Instrument purchases, the new levels will be the number of Instruments that supplier was actually able to supply during the prior Contract Period plus [*]. If Supplier is unable to sell to CMS sufficient Instruments to permit CMS to meet the targeted Instrument purchases for [*] Contract Periods, then CMS may terminate this Agreement by giving Supplier written notice of such termination effective thirty (30) days after the date notice is delivered or mailed in accordance with Section 12. Such termination shall be without liability to either party, except for such other liabilities as may otherwise specifically be set forth in this Agreement. b. At Supplier's request, CMS shall submit to Supplier such reports as are customarily provided to suppliers similarly situated with Supplier at CMS's standard charge for such reports then in effect. -3- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 4 c. CMS shall make purchases of Products hereunder by submitting firm purchase orders to Supplier. d. Upon execution of this Agreement, CMS shall issue to Supplier a purchase order for thirty-five (35) Instruments, which shall be delivered by Supplier in accordance with the provisions of Section 4.a. of this Agreement. Within a reasonable time following the execution of this Agreement, CMS shall issue purchase order(s) for such quantities of Reagents as may be recommended by Supplier in order to fill orders from all former customers of Supplier (referred to in Section 4.r of this Agreement) in a timely fashion. e. CMS shall provide to Supplier qualified leads for sales or placements of the instruments in the Territory in an electronic mail format which is mutually acceptable to the parties. To that end, CMS will make available to Supplier CMS's standard software to enable Supplier to communicate only with designated CMS employees via electronic mail and by which CMS employees can communicate qualified leads to Supplier. Supplier's right to use CMS's software shall terminate upon the expiration or termination of this Agreement, howsoever arising. Supplier shall not assign, transfer, copy, duplicate or make any use of CMS's software except as specifically set forth in this Agreement. f. CMS may return, for full credit or replacement, any Product for which CMS is required to give a customer credit or replacement Product due to a defect or deficiency in the Product, provided that CMS first obtains from Supplier a returned goods authorization which shall not be unreasonably withheld or delayed by Supplier. g. CMS shall provide to Supplier in writing, after site visits to the accounts, account profile information on five hundred (500) accounts selected by CMS and Supplier within [*] of the execution date of this Agreement, to include such information as the parties may mutually agree. h. During each Contract Period, CMS shall disburse [*] for purposes of Product promotion and training which shall include, at CMS's discretion, out-of-pocket costs for attendance at appropriate trade shows and conventions, out-of-pocket costs (other than those of Supplier) incurred at Product training sessions, seminars and workshops and in connection with the preparation of miscellaneous Product literature, which literature shall be reviewed and approved, in advance, by Supplier. 4. Conduct of Supplier. a. Supplier shall ship promptly, but in any event not later than thirty (30) days from receipt of order, CMS's orders for Reagents. Supplier shall ship promptly, but in any event not later than sixty (60) days from receipt of order, CMS's orders for Instruments; provided, however, that with respect to CMS's initial order for Instruments, Supplier shall ship ten (10) Instruments within thirty (30) days from receipt of CMS's initial order, ten (10) Instruments within sixty (60) days of receipt of CMS's initial order and fifteen (15) Instruments within ninety (90) days of receipt of CMS's initial order. Time is of the essence with respect to Supplier's shipments of Products. All orders shall be shipped f.o.b. Santa -4- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 5 Barbara, California, at which point title and risk of loss shall pass from Supplier to CMS, freight and insurance prepaid, to such CMS location(s) as CMS may designate. Supplier shall cooperate with CMS in arranging for drop shipments of Product to customers on a case by case basis. b. Supplier shall give at least ninety (90) days' prior written notice of increase of price of any Product and honor CMS's existing purchase orders at the prices in effect immediately prior to the effective date of each price increase. Price increases shall be effective only on the first day of any calendar quarter immediately following the expiration of the notice period. c. Supplier shall notify CMS immediately in writing should Supplier become aware of any defect or condition which renders any of the Products in violation of any statute or regulation, or which in any way alters the specifications or quality of the Products. d. Supplier shall ship Reagents so that [*] the shelf life described in Schedule B will be remaining at the time of receipt at CMS's facility, or at CMS's customer's facility, if drop-shipped. If requested to do so by CMS, Supplier shall take back for full invoice credit plus shipping charges any dated Reagents shipped contrary to this provision. e. Supplier shall execute and abide by the terms of CMS's Continuing Guaranty, a copy of which is attached hereto as Schedule C and incorporated herein by reference, as modified herein. The terms and provisions of the Continuing Guaranty shall survive the termination of this Agreement. f. Supplier shall provide CMS with a Certificate of Insurance which meets the requirements of Section D of the Continuing Guaranty on or prior to execution of this Agreement. Supplier shall provide CMS with renewal insurance certificates in the form mandated by Section D of the Continuing Guaranty during the term of this Agreement, without demand therefor by CMS. Notwithstanding any provision of the Continuing Guaranty to the contrary, the amount of insurance required of Supplier pursuant to the Continuing Guaranty during the first Contract Period shall be [*]; for the next subsequent Contract Period, [*]; for all subsequent Contract Periods of the term of this Agreement, [*]. g. Supplier shall provide to CMS's sales personnel training in the use, technical properties, sale, competitive features and benefits of the Products as may be reasonably requested from time to time by CMS. For purposes of such training, Supplier shall make available at Supplier's expense, all necessary, qualified instructors, appropriate types and quantities of training materials and Products. CMS shall provide transportation and lodging expenses for CMS personnel for the training of CMS sales personnel by Supplier. (i) Within one-hundred twenty (120) days following the execution of this Agreement, Supplier shall provide and CMS shall organize such training in such format as may be agreed upon between the parties in advance, to CMS sales personnel at no fewer than five (5) CMS branch locations. (ii) Additionally, at Supplier's expense, Supplier shall provide to CMS's sales personnel at CMS's National Sales Meeting in Phoenix, Arizona on February 14, 1993, a qualified instructor, a video presentation concerning Supplier's Products and organization and appropriate types and quantities of training materials, including, Product literature, Product competitive matrices, cost-per-test data, and introductory sales training manual materials as may be agreed between the parties. Supplier will make -5- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 6 the presentation as outlined in CMS's December 4, 1992 "kickoff" memorandum to Supplier. Supplier shall provide CMS with adequate opportunity to review and approve all such written and videotaped materials in advance. CMS's approval shall not be unreasonably withheld or delayed. (iii) Supplier shall provide and CMS shall organize no fewer than [*] per Contract Period on the topic of immunohistochemical methods to CMS customers, prospective customers and user-groups at such locations as the parties mutually determine, in their reasonable business judgment, may potentially offer the most beneficial commercial opportunities. CMS shall within [*] after the execution of this Agreement purchase [*] demonstration instruments (the "Demonstration Units") at CMS's demonstration laboratories. Supplier shall sell Demonstration Units to CMS at a cost of [*] and shall install, maintain and provide upgrades for same sufficient to insure that the instruments function at a level which is at least equal at all times to the most advanced model available for purchase by CMS from Supplier. h. Supplier shall provide technical support to CMS's sales personnel and promptly provide to CMS such additional types and quantities of technical information developed or acquired by Supplier from time to time as may reasonably be expected to be of assistance to CMS in fulfilling its obligations hereunder. Supplier will provide at its own expense a toll-free long distance telephone service for customer and CMS sales personnel support. Supplier has represented to CMS that on or before July 1, 1993, Supplier shall have established at least [*] regional technical centers for the western, mid-western, eastern and southern regions, respectively, with each such center to be staffed by Supplier with a qualified general manager and staff scientist. Supplier's regional technical centers shall provide all reasonable assistance to purchasers of the Products and to CMS sales personnel with all technical aspects of the Products and with Instrument installation, care and use. CMS is entering into this Agreement in reliance on such representation. i. Supplier shall provide, at its expense, reasonable quantities of such instruction and training manuals and point of sale literature as may from time to time be requested by CMS for use in connection with the distribution and sale of the Products. Subject to CMS's prior written approval, the CMS name will be incorporated in Supplier's advertising literature for the Products intended for distribution by CMS sales representatives. If requested to do so by CMS, Supplier shall furnish CMS with suitable copy and photographs for use by CMS in cataloging the Products. j. Supplier shall be responsible for the appointment of qualified service representatives and shall bear all costs associated with the service and repair of the Instruments, and shall ensure that authorized Instrument service representatives will be available on-site at the customer's facility within 48 hours or within industry standard, whichever is shorter, following request for any Instrument repair which cannot be resolved through the exchange of parts via mail between the customer and Supplier. k. Any Products owned by CMS and rendered unsalable, in CMS's reasonable opinion, due to a change in any Product specification, discontinuation or elimination by Supplier of any Product from its product offering, release by Supplier of any improved or updated version of any Product, shall be repurchased from CMS by Supplier within thirty (30) days following CMS's request -6- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 7 therefor at the price paid for such Product(s) by CMS. Supplier shall additionally pay for return freight and related transportation and insurance charges for all such Products. l. (i) For each calendar quarter following the execution hereof, CMS shall carry in stock an average inventory of Reagents to provide adequate and timely service to CMS's customers at [*] service level as reflected on CMS's Key Supplier (SA385) Report. CMS shall review its inventory at least once in each calendar quarter and identify those Reagents which it considers, in its absolute discretion, to be slow-moving. CMS shall notify the Supplier in writing, describing such Reagents, and Supplier shall, exchange all such Reagents for Reagents which are selected by CMS and Supplier shall pay all associated freight therefor. (ii) CMS shall maintain in its inventory at least such number of Instruments as may be equal to the average number of Instruments installed by Supplier during the previous [*]. m. Supplier shall, at its sole cost and expense, provide appropriate personnel, Instruments and Reagents to qualified prospective customers identified by CMS and for conducting parallel performance studies and Product evaluations as may be reasonably requested by qualified prospective customers. Qualification of customers shall be as mutually agreed by the parties. CMS will assist Supplier in conducting the customer evaluations. Supplier reserves the right to affix a marking to such Instruments indicating that such Products are "For Demonstration Purposes Only." Such marking shall not be removed or obliterated by CMS. n. Supplier agrees to bar code the Reagents at the lowest saleable unit using symbology 3 of 9 in accordance with Health industry Bar Code ("HIBC"). Additionally, where applicable, Reagents will be bar coded to include standard unit, alternate unit, lot number and expiration date. o. Supplier shall notify CMS in writing of any special requirements for the storage and handling of the Products and any laws, rules, regulations, orders, ordinances and requirements of all local, state and federal governments and agencies having jurisdiction over the Products, including, but not limited to the requirements of the Food and Drug Administration which may impact CMS's obligations with respect to the distribution and sale of the Products. p. Supplier shall provide to CMS qualified leads which may come to its attention for sales or placements of the Instruments in the Territory in a format which is mutually acceptable to the parties. q. Supplier shall provide CMS with special pricing: (i) on any large quantity order for Products which may be requested by any CMS customer; (ii) in connection with customer leasing deals; (iii) in connection with Reagent rental deals and (iv) and where required to meet competition. With respect to Product sales which arise pursuant to the provisions of Sections 4 (i), (ii), (iii) and (iv), Supplier guarantees to CMS a gross profit on each Instrument [*] and a gross profit on each Reagent [*], which shall be debited from payments otherwise due from CMS to Supplier, except that Supplier shall pre-approve in writing (in such format as the parties may mutually agree) any reduction in the attached Schedules A or B prices as may be required to guarantee -7- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 8 CMS such gross profit percentages. Notice of the acceptance or rejection of each such request for pre- approval shall be communicated by Supplier to CMS promptly following CMS's request therefor. r. Upon execution of this Agreement, Supplier shall provide CMS with all necessary and appropriate information concerning all of Supplier's existing customers for the Products in the Territory which customers shall thereafter be the customers of CMS. Supplier shall cooperate with CMS in notifying each of the former customers of Supplier of the appointment of CMS as Supplier's exclusive distributor of the Products in the Territory and with the orderly transition of such customer accounts to CMS. s. For each month of the first Contract Period, Supplier shall make available appropriate employees to meet with CMS for the purpose of general business review discussions either via telephone conference or personal meetings, as the parties may subsequently agree. 5. Price and Payment Terms. a. Supplier shall supply and ship Products at the prices and subject to the discounts shown on Schedules A and B hereto for the duration of the first Contract Period. Thereafter, such prices may be reduced by Supplier, but may be increased only according to the terms and provisions of this Agreement and such discounts shall not be decreased. b. Supplier represents and warrants that the price and terms pursuant to which the Products are and will be sold to CMS pursuant to this Agreement shall be no less favorable than those made available to the Supplier's most favored distributors, if any. c. CMS shall pay for Product orders within thirty (30) days from the date of delivery by Supplier during the first Contract Period and within forty-five (45) days from the date of delivery in all subsequent Contract Periods; provided, however, that CMS shall not be in breach of this Agreement unless payment is received by Supplier greater than fourteen (14) days overdue. Notwithstanding any provision set forth in this Agreement to the contrary, CMS shall pay for its initial order for the first thirty-five (35) Instruments described in Section 3.d. hereof at the time the purchase order is issued to Supplier. d. CMS shall be entitled to resell Products on such terms as it may, in its sole discretion, determine, including, without limitation, price, returns, credit and discounts. 6. Term and Termination. a. The initial term of this Agreement shall be for a period of five (5) years, plus an initial ninety (90) day launch period from the date this Agreement is executed on behalf of CMS, and, unless notice shall be given by one party to the other within ninety (90) days of such anniversary date (which shall be calculated from the ninety-first (91st) day following the execution date hereof) and thereafter subsequent annual anniversary dates, shall be automatically renewed for additional and successive terms of one (1) year each. -8- 9 b. This Agreement shall terminate immediately upon written notice by the non-breaching party if either party (i) commits or suffers an act of bankruptcy or insolvency or, except as otherwise provided in this Agreement, (ii) fails to cure any material breach in the provisions of this Agreement within thirty (30) days after receipt of written notice of such breach, except that any breach including the payment of money must be cured within fourteen (14) days after the due date of any such payment, unless such payment of money is then being disputed in good faith. c. On the termination or non-renewal of this Agreement, howsoever arising, Supplier shall continue to honor CMS's purchase orders for Products up to the effective date of termination or non-renewal. d. The rights and duties of each party under this Agreement and the Schedules hereto in respect of performance prior to termination or non-renewal shall survive and be enforceable in accordance with the terms of this Agreement. e. Upon termination or non-renewal of this Agreement Supplier shall repurchase from CMS, at CMS's request, and at CMS's cost therefor, such Products as are then owned by CMS. Delivery of Products repurchased from CMS hereunder shall be f.o.b. CMS's premises. 7. Right of First Refusal If Supplier desires to enter into a transaction resulting in the sale by Supplier of all or substantially all of its stock or assets, Supplier shall first give written notice of such intention to CMS, which shall have the option to purchase such interest at a price and on such terms and conditions as may be mutually worked out between the parties in good faith. If the parties are unable in good faith to agree on mutually satisfactory terms for the proposed sale within [*] after the receipt by CMS of such notice or, if prior to the expiration of [*] period CMS declines to purchase, then Supplier shall have the right to enter into such a transaction with any third party upon such terms and conditions as may be agreed by Supplier and any such third party. 8. Warranties. a. In addition to the warranties of Supplier set forth in this Agreement and in the Continuing Guaranty which is attached hereto as Schedule C, Supplier warrants that each of the Products will conform to specifications set forth in Product literature prepared by or on behalf of Supplier and that the Products will comply and be manufactured, assembled, packaged, sterilized (if applicable), labeled and shipped in compliance with all applicable Federal, state and local laws, orders, regulations and standards. b. Supplier and CMS shall extend to customers Supplier's Warranties for the Instruments and Reagents which are set forth on Schedule D. Supplier shall not modify any Product Warranty without CMS's prior written consent, which consent shall not be unreasonably withheld or delayed. Supplier warrants and represents that the Products will perform in accordance with, and that Supplier shall strictly comply with, the terms of Supplier's Product Warranties. -9- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 10 9. Trademarks. a. Supplier hereby grants to CMS the royalty-free right to use the Supplier's trademarks on the Products during the term of this Agreement, it being expressly understood that CMS shall discontinue the use of such trademarks upon the termination of this Agreement (except in connection with the distribution and sale of CMS's remaining inventory of Products in the event that CMS does not elect to exercise its rights under Section 6.e. hereof) and disclaims any rights in the trademark other than the said license. b. Supplier recognizes that CMS is the owner of the trademarks and tradenames denoting CMS or CMS products which it may elect to use in the promotion and sale of the Products and that Supplier has no right or interest in such trademarks or tradenames. 10. Confidentiality. Each party acknowledges the confidential nature of information that may be disclosed hereunder (including, but not limited to, the names of CMS's customers) and agrees to retain such information in confidence. This provision shall survive the termination of this Agreement for a period of two (2) years. 11. Force Majeure. The obligations of either party to perform under this Agreement shall be excused during each period of delay caused by such matters as strikes, shortages of power or raw material, government orders or acts of God, which are reasonably beyond the control of the party obligated to perform. The affected party shall make best efforts to remedy the effects of such force majeure. Any force majeure event shall not excuse performance by the party but shall delay performance, unless such force majeure continues for a period in excess of ninety (90) days. In such event, the party seeking performance may cancel its obligations hereunder. 12. Notices. Any notice required by this Agreement shall be deemed sufficient if sent by facsimile or three (3) days after being sent by certified mail, postage prepaid, to the party to be notified at the address set forth in the initial section of this Agreement until notice of a different address is supplied. 13. Entire Agreement. This Agreement, including the Schedules hereto, constitutes the entire Agreement between the parties relating to the subject matter hereof and supersedes all prior agreements and understandings, whether written or oral, between the parties with respect to such subject matter. In ordering and delivery of the Products, the parties may employ their standard forms, but nothing in those forms shall be construed to modify or amend the terms of this Agreement. 14. Applicable Law. This Agreement shall be governed by the laws of the state of Texas (excluding its conflict of laws principles) where jurisdiction and venue shall lie. 15. Assignments. This Agreement shall not be assigned or transferred by Supplier either voluntarily or by operation by law without the prior written consent of CMS. -10- 11 16. Amendment. No amendment or modification of the terms of this Agreement shall be binding on either party unless reduced to writing and signed by an authorized officer of the party to be bound. 17. Existing Obligations. Each party represents and warrants that the terms of this Agreement do not violate any existing obligations or contracts of such party. Each party shall defend, indemnify and hold harmless the other party from and against any and all claims, demands, liabilities and causes of action which are hereafter made or brought against such other party which allege any such violation. 18. Relationship of the Parties. Nothing herein contained shall be deemed to be or be construed as constituting either party as the agent or partner of the other. 19. Successors and Permitted Assigns. This Agreement shall inure to the benefit of and be binding upon the parties hereto and their permitted successors and assigns. 20. Counterparts. This Agreement may be executed in one or more counterparts, each of which shall be deemed an original for all purposes. 21. Attorneys' Fees. If any action is commenced to enforce any of the terms of this Agreement, the prevailing party will have the right to recover its reasonable attorneys' fees and costs of suit. -11- 12 IN WITNESS WHEREOF, the parties have, by their duly authorized officers, executed this Agreement on the dates set forth below. BIOTEK SOLUTIONS, INC. By: /s/ ELLIOT FRIEDMAN ------------------------------- Elliot Friedman, President Date: 1-14-93 ------------------------------- CURTIN MATHESON SCIENTIFIC, INC. By: /s/ JOHN M. DANIELS ------------------------------- John M. Daniels, Vice President Clinical Marketing Date: 1-18-93 ------------------------------- -12- 13 [ * ] TM -- 1000 Techmate 1000
APPROVAL % OFF LEVEL LIST PRICE GP% GGP% - ------------------ ------ ----- ---- ---- [*] [*] [*] [*] CMS REPS [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] - -------------------------------------------------------------------------- [*] [*] [*] [*] [*] [*] [*] [*] BIOTEK GM [*] [*] [*] [*] CMS REGION MGR [*] [*] [*] [*] CMS AREA VP [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*]
BELOW [*] WILL BE HANDLED ON A CASE BY CASE BASIS * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 14 SDK601 STANDARD SECONDARY DETECTION KIT (USE FOR ALL REAGENTS/DISPOSALS)
% OFF APPROVAL LEVEL LIST PRICE GP% GGP% - --------------------- ----- ----- ---- ----- [*] [*] [*] [*] CMS REPS [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] - ------------------------------------------------------------------------------- [*] [*] [*] [*] BIOTEK GM [*] [*] [*] [*] CMS REG MGR [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] - ------------------------------------------------------------------------------- [*] [*] [*] [*] BIOTEK GM [*] [*] [*] [*] CMS AREA VP [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] - ------------------------------------------------------------------------------- [*] [*] [*] [*] ELLIOT FREIDMAN [*] [*] [*] [*] CMS VP SALES [*] [*] [*] [*] CMS VP MKTNG [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*]
* Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 15
CATALOGUE SUGGESTED NUMBER DESCRIPTION CMS COST LIST - --------- ------------------------------- -------- --------- TM1000 TechMate 1000 Immunostainer (1) [*] [*]
(1) see attached technical specification sheet * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 16
CATALOGUE SUGGESTED NUMBER DESCRIPTION CMS COST LIST - --------- ---------------------------------------------- -------- --------- REAGANTS SDK601 Standard Secondary Detection Kit (600 tests) $ [*] $ [*] SDK602 Overnight Secondary Detection Kit (600 tests) $ [*] $ [*] SDK603 ER/PR Secondary Detection Kit (600 tests) $ [*] $ [*] ADB250 Antibody Dilution Buffer (250 ML) $ [*] $ [*] IPE100 IPENZ Enzyme Kit (3 Bottle Set) $ [*] $ [*] NEG025 Negative Control (25 ML Bottle) $ [*] $ [*] PAB101 Actin (Pan Muscle) $ [*] $ [*] PAB102 Actin (Smooth Muscle) $ [*] $ [*] PAB103 Chromogranin $ [*] $ [*] PAB104 Collagen Type IV $ [*] $ [*] PAB105 Desmin $ [*] $ [*] PAB106 Epithelial Membrane AG $ [*] $ [*] PAB107 Factor Viii Related AG $ [*] $ [*] PAB108 GFAP $ [*] $ [*] PAB109 HMB 45 $ [*] $ [*] PAB110 Kappa Light Chain $ [*] $ [*]
* Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 17 PAB111 Keratin (Pan) $ [*] $ [*] PAB112 L-26 (CD20) $ [*] $ [*] PAB113 Lambda Light Chain $ [*] $ [*] PAB114 LCA (CD45) $ [*] $ [*] PAB115 Leu7 $ [*] $ [*] PAB116 Leu M1 (CD15) $ [*] $ [*] PAB117 Lysozme $ [*] $ [*] PAB118 Neurofilaments $ [*] $ [*] PAB119 Neuron Specific Enolase $ [*] $ [*] PAB120 Prostatic acid Phosphatase $ [*] $ [*] PAB121 Proliferating Cell Nuclear AG $ [*] $ [*] PAB122 S-100 $ [*] $ [*] PAB123 UCHL-1 $ [*] $ [*] PAB124 Vimentin $ [*] $ [*]
-2- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 18 DISPOSABLES RWP101 Reagent Wicking Pads (Box of 50) $ [*] $ [*] CTL100 Control Checkerboard Slides (Box of 100) $ [*] $ [*] POP075 Probe On Plus Slides (Case of 1440) $ [*] $ [*] POP130 Double Thick Probe On Slides (Gross) $ [*] $ [*]
(1) Shelf life of all reagents guaranteed for one year from date of delivery at CMS when stored according to instructions. -3- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 19 Curtin Matheson Scientific, Inc. CONTINUING GUARANTY A. BIOTEK SOLUTIONS, INC. referred to as ("Seller"), having its principal office and place of business at 120 B Cremona Dr., Santa Barbara, CA 93117, hereby guarantees that all Products (including their packaging, labeling and shipping) comprising each shipment or other delivery hereinafter made by Seller (hereinafter referred to as "Products") to or on the order of Curtin Matheson Scientific, Inc., a Delaware corporation, having its principal place of business at 9999 Veterans Memorial Drive, Houston, Texas 77032, or to any of its branches, divisions, subsidiaries or its affiliate, Matheson Science, Inc., or any of their customers (hereinafter collectively referred to as "CMS"), are, as of the date of such shipment or delivery, in compliance with applicable federal, state and local laws, and any regulations, rules, declarations, interpretations and orders issued thereunder, and conform to representations and warranties made by Seller in its advertising, product labeling and literature. B. Further, with respect to any Product that is privately labeled for CMS, Seller agrees to make no change in such Products or the CMS artwork on the labeling or packaging relating thereto without first obtaining the written consent of CMS. Seller recognizes that CMS is the owner of the trademarks and trade names connoting CMS which it may elect to use in the promotion and sale of such private label Products and that Seller has no right or interest in such trademarks or trade names. Seller shall periodically analyze and review packaging and labeling for any Products which are private labels for CMS to ensure conformity with the provisions of paragraph A hereof and the adequacy of Product warnings and instructions. C. Seller hereby agrees that it will reimburse CMS for all reasonable out-of-pocket costs and expenses incurred in connection with any product corrective action or recall relating to the Products which is requested by Seller or required by any governmental entity. D. Seller agrees to procure and maintain on an occurrence form basis product liability insurance with respect to the Products and contractual liability coverage relating to this Guaranty, with Insurer(s) having Best's rating(s) of 8 or better, naming CMS as an additional Insured (Broad Form Vendors Endorsement), with minimum limits in each case of $1,000,000. Seller shall promptly furnish to CMS a certificate of insurance and renewal certificates of insurance evidencing the foregoing coverages and limits. The insurance shall not be canceled, reduced or otherwise changed without providing CMS with at least ten (10) days prior written notice. E. Seller agrees to and shall indemnify and hold harmless CMS (and with respect to Subparagraph E.(i) below, CMS customers) from any and all claims, actions, costs, expenses and damages, including attorneys fees and expenses arising out of: (i) any actual or alleged patent, trademark or copyright infringement in the design, composition, use, sale, advertising or packaging of the Products; (ii) any breach of the representations or warranties set forth in this Guaranty, (iii) the sale or use of the Products where such liability results from the act of omission of Seller (whether for breach of warranty, strict liability in tort, negligence or otherwise). F. Seller agrees to and shall provide to CMS Material Safety Data Sheets and other information concerning any Product as required by then applicable federal, state or local law. G. Seller agrees to and shall accept, at its facility, all of CMS's unsold or expired Products containing hazardous chemicals, materials or substances for disposal, recycling or use. CMS shall be responsible for packing and transportation costs to Seller. Seller shall be responsible for all other costs, including, without limitation, any costs associated with Seller's disposal, recycling or use. H. The representations and obligations set forth herein shall be continuing and shall be binding upon the Seller and his or its heirs, executors, administrators, successors and/or assigns, whichever the case may be, and shall inure to the benefit of CMS, its successors and assigns and to the benefit of its officers, directors, agents and employees and their heirs, executors, administrators and assigns. I. The agreements and obligations of Seller set forth in this Guaranty are in consideration of purchases made by CMS from Seller and said obligations are in addition to (and supersede to the extent of any conflict) any obligations of Seller to CMS or CMS to Seller. The obligations of Seller under this Guaranty shall survive and be enforceable in accordance with its terms. SELLER BIOTEK SOLUTIONS, INC. - -------------------------------------------------------------------------------- Full Corporate Name or Name Under Which Seller's Business is Conducted /s/ ELLIOT P. FRIEDMAN - -------------------------------------------------------------------------------- Signature of Authorized Representative PRESIDENT - -------------------------------------------------------------------------------- Title ELLIOT D. FRIEDMAN - -------------------------------------------------------------------------------- Printed Name January 9, 1993 - -------------------------------------------------------------------------------- Date CURTIN MATHESON SCIENTIFIC, INC. - -------------------------------------------------------------------------------- - -------------------------------------------------------------------------------- Title 20 ADDENDUM AND ADVANCE REPAYMENT AGREEMENT This Addendum and Advance Repayment Agreement (the "Addendum"), made and entered into by and between Curtin Matheson Scientific, Inc., a Delaware corporation ("CMS") and BioTek Solutions, Inc., a California corporation ("BioTek"), hereby recites: WHEREAS, the parties to this Addendum executed that certain Distribution Agreement dated January 18, 1993, as amended (the "Agreement"); and WHEREAS, the parties to this Addendum believe that it is in their best interests to modify and amend the Agreement; and WHEREAS, on November 3, 1994, CMS made a business advance to BioTek of the sum of [*], which Biotek promised to pay to CMS by or before December 31, 1994 (the "Advance"); and WHEREAS, to date, BioTek has failed and/or refused to repay the Advance; and WHEREAS, the parties to this Addendum desire to make provision for the repayment of the Advance. NOW, THEREFORE, for and in consideration of the premises and the mutual promises, covenants and agreements herein contained, the parties to this Addendum agree as follows: 1. Modification to Inventory Provision of Agreement. Paragraph 4(I)(ii) of the Agreement shall be deleted and the following shall be inserted in its stead: Notwithstanding any provision set forth in the Agreement or in this Addendum to the contrary, CMS shall be required to maintain in its inventory such number of Instruments as it may deem appropriate to conduct business as contemplated by the Agreement, as modified by this Addendum, but in any event not less than [*] Instruments to be used for demonstration and/or evaluation purposes. From the date of execution of this Addendum through April 30, 1995, the maximum number of Instruments which CMS shall be obligated to carry as its inventory investment in BioTek Instruments for each calendar month shall be a number equal to [*] the average number of Instruments billed (for final sale) by CMS to its customers during the immediately preceding three calendar months. For the period beginning May 1, 1995 and thereafter during the term of the Agreement, the maximum number Instruments which CMS shall be obligated to carry as its inventory investment in BioTek Instruments for each calendar month shall be a number equal to [*] the * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 21 average number of Instruments billed (for final sale) by CMS to its customers during the immediately preceding three calendar months. With respect to any number of Instruments which CMS may have in its inventory (including new, demonstration and evaluation units) in any calendar month in excess of the product of the applicable formula described above, beginning with CMS's second scheduled payment to BioTek in February, 1995, CMS shall be entitled to deduct from amounts otherwise payable to BioTek amounts equal to the number of excess Instruments multiplied by the then-current cost of each. Notwithstanding any provision set forth herein to the contrary, to the extent that CMS's anticipated second February 1995 payment to BioTek for Instruments and Reagents is insufficient to provide for such excess and/or in the event that any unrecovered excess remains upon termination or non-renewal of the Agreement, BioTek agrees to make immediate payment of the net difference to CMS. Example: Assume that CMS billed (for final sale) to customers 8 Instruments in October, 9 Instruments in November and 11 Instruments in December, for a average (rounded) of 9 units per calendar month during the period. Applying the formula, that number would be multiplied by three, for [*]. If on the next succeeding payment date, CMS's records reflected that it had a total of 35 Instruments (including new, demonstration and evaluation units) in its inventory, CMS would be obligated to carry as its inventory investment [*], and CMS would be permitted to deduct from payments otherwise due to BioTek an amount equal to the cost associated with [*] Instruments, as further described above. In any calendar month in which the actual total number of Instruments which CMS has in its inventory (including new, demonstration and evaluation units) is less than the product of the applicable formula described above, Supplier shall, at its expense, drop ship any Instruments ordered by CMS during the subject calendar month directly to CMS's customers in accordance with CMS's directions. For purposes of this Addendum, the calculation of the total actual Instruments in CMS's inventory for each calendar month shall be made on each payment date and the determination of CMS with respect to such calculations shall be final. 2. Modification to Payment Terms of Agreement. Paragraph 5(c) of the Agreement shall be deleted and the following shall be inserted in its stead: Except as otherwise set forth in this Addendum, for Instruments and Reagents billed to CMS from BioTek from the date of execution of this Agreement through June 30, 1995, CMS will pay BioTek (net of deductions described above) within fifteen (15) days from the date of invoice. For Instruments and Reagents billed to CMS from BioTek on and after July 1, 1995, CMS will pay BioTek (net of deductions described above) within forty-five (45) days from the date of invoice; -2- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 22 provided, however, that CMS shall not be in breach of this Agreement unless payment is received by BioTek greater than fourteen (14) days overdue. 3. BioTek's Advance Repayment Obligations. BioTek promises to pay to the order to CMS the principal [*] with interest on the unpaid principal from January 1, 1995 until maturity at a rate equal to "prime" plus [*]. "Prime" shall mean the prime lending rate established from time to time by Texas Commerce Bank of Houston, Texas, adjusted monthly as of the fifteenth day of each month during which this obligation shall be outstanding and not yet due. Overdue principal and (to the extent permitted by law) overdue interest shall bear interest payable at the highest rate permissible by applicable law. Principal and accrued interest thereon will be payable in installments as follows: a. Interest accrued on the principal outstanding from January 1, 1995 to the date of this Agreement plus [*] shall be payable upon execution of this Agreement and shall be paid by BioTek to CMS through a credit against invoices from BioTek to CMS for Instruments and Reagents purchased by CMS under the Agreement; and b. [*] hereunder shall be due and payable on each of February 1, 1995 and March 1, 1995. Such amount may be paid by BioTek to CMS through a credit against invoices from BioTek to CMS for Instruments and Reagents purchased by CMS under the Agreement, if then available; provided that the payment described above shall be due and payable on each of February 1, 1995 and March 1, 1995 in any event, in coin or currency of the United States. c. BioTek agrees that this Advance repayment obligation shall be governed by and construed in accordance with the laws of the State of Texas (without regard to the conflicts of law principles thereof). d. Payment will be made by BioTek to CMS at 9999 Veterans Memorial Drive, Houston, Texas 77038 or such other place as CMS may require. BioTek may prepay the foregoing obligation, without penalty, in whole or in part, with accrued interest to the date of such prepayment or the amount prepaid. 4. Miscellaneous. a. The Agreement and this Addendum shall be binding up and inure to the benefit of the parties and their respective successors and/or assigns. b. The agreements and obligations of this Addendum are in addition to and shall supersede to the extent of any conflict, any provision in the Agreement. -3- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 23 c. This Addendum shall be effective as of the date executed by CMS and, except with respect to BioTek's Advance repayment obligations, shall terminate or expire concurrently with the Agreement. IN WITNESS WHEREOF, the parties hereto have set their hands as of the dates shown below. CURTIN MATHESON SCIENTIFIC, INC. BIOTEK SOLUTIONS, INC. By: /s/ J C LEWIS By: /s/ MICHAEL C. MILLER ------------------------------- ------------------------------- Title: VP-Controller Title: President & CEO ---------------------------- ---------------------------- Date: 1-12-95 Date: 1-12-95 ----------------------------- ----------------------------- -4- EX-10.17 6 NOVOCASTRA LABS LTD DISTRIBUTION AGREEMENT 1 EXHIBIT 10.17 DISTRIBUTION AGREEMENT AGREEMENT entered into this 19th day of August, 1992, (the "Agreement"), between Novocastra Laboratories Ltd., a United Kingdom corporation ("Supplier"), and Ventana Medical Systems, Inc., a California, U.S.A. corporation ("Distributor"). WITNESSETH: WHEREAS, Supplier makes and sells certain monoclonal antibodies, and related products for clinical use and research use which Supplier desires to have distributed by Distributor within a certain market and under Distributor's own trademark and tradename. WHEREAS, Distributor has developed an apparatus that will automate the immunohistochemical staining process used for research and desires to use certain of Supplier's monoclonal antibodies with apparatus. WHEREAS, Distributor has the necessary technical expertise, sales organization and marketing expertise to distribute said apparatus and monoclonal antibodies; and WHEREAS, Supplier and Distributor are desirous of entering into an arrangement for Distributor to market and distribute such products on the terms and conditions set forth herein. NOW, THEREFORE, in consideration of the premises and mutual covenants and agreements, as herein contained, the parties agree as follows: 1. Appointment. Supplier hereby appoints Distributor as the distributor of monoclonal antibodies and supplies as listed in Exhibit A attached hereto, hereinafter referred to as ("Product(s)"). Distributor shall buy Products from Supplier in concentrated format. The Distributor shall purchase from the Supplier the concentrated monoclonal antibodies on a weight basis. The basis shall be: dollars per milligram of active antibody protein, as stated in the attached Exhibit A. Distributor shall repackage Products and sell same under its own trademark and trade name. Distributor shall be allowed to sell Products to customers throughout the world (the "Territory") for use with its own Automated Immunohistochemistry System only, (the "Market"). The distribution rights granted Distributor by Supplier herein are exclusive within the Market. Distributor acknkowledges that it has no authority whatsoever to sell Product outside of the Market. In addition, Distributor further acknowledges that customers in the Market defined in this Agreement will use Products for research use only, or investigational use only or for use as an in vitro diagnostic and distributor will take all actions necessary to label Products in compliance with applicable law and regulation as promulgated by the United States Food and Drug Administration, ("FDA"), as may be amended from time to time. Distributor acknowledges that it does not have authority to sell Products for non-automated Immunohistochemical applications. The Distributor has the right to pursue and obtain FDA In Vitro Diagnostic use labeling at the Distributor's cost. The Supplier will assist the Distributor with any available data which would be useful for FDA approval. The supplier will verify in writing that they have the cell lines producing the monoclonal antibodies in their possession and directly produce the antibodies. The Supplier will make reasonable efforts to meet the US FDA guidelines for GMP (Good Manufacturing Practices). The Distributor will assist the Supplier in this effort. 2 2. Distributor Responsibilities. During the term of this Agreement, Distributor shall: a. Use its best efforts at all times to promote and increase sale of Products within the Territory for the Market through, among other means, advertising, demonstrations, sales promotion programs, and attendance at exhibitions, trade shows and congresses; b. Maintain all times inventories or products at levels adequate to service customer demand in the Territory for the Market; c. Maintain a qualified sales organization which actively and effectively solicits orders for Products; d. Inform Supplier promptly of any facts which may come to its attention or opinions likely to be relevant in relation to the manufacture, sale, use, titration or development of Products within or without the Market; e. Refer promptly to Supplier all inquiries for Products from customers outside the Market; f. Comply with all regulations and laws applicable to a distributor or Products; g. Sell products only under its own trademarks and trade names. 3. Supplier Responsibilities. During the term of this Agreement, Supplier shall: a. Fill Distributor orders for Products as soon as commercially practicable, or within sixty (60) days, after receipt thereof; b. Absent special circumstances, notify Distributor of changes to Products specifications at least sixty (60) days prior to such change; c. Provide Distributor with current technical information to aid in Distributor's sales activity; d. Handle any recall, whether required by a government agency or Supplier. 4. Filling of Orders. Distributor will accept an annual purchase order of Products. Products will be shipped and invoiced pursuant to such purchase order on a quarterly basis. Distributor shall submit the first annual purchase order within fifteen (15) days from the execution of this Agreement by both Parties. Subsequent purchase orders shall be submitted every twelve (12) months after the first purchase order for as long as this Agreement remains in effect. The Supplier will accept changes to the annual purchase order on a quarterly basis with the changes being made within ninety (90) days of the receipt of the change request. 5. Purchase Price. (a) Each Product subject to this Agreement shall be sold by Supplier to Distributor at the price specified in Exhibit A and be priced in U.S. dollars. Supplier may change prices for Products sold hereunder at the beginning of each agreement year upon ninety (90) days written notice. The -2- 3 Supplier will limit any annual price increase to no more than ten (10%) percent per year. The parties may agree from time to time to accelerate implementation of price changes of Supplier's to Distributor in the case of rapidly changing market conditions which cause the Supplier to have its cost dramatically increased. The parties may agree from time to time to accelerate implementation of price changes of Supplier's prices to Distributor in the case of rapidly changing market conditions. Distributor shall be entitled to resell in the Territory and within the Market on a exclusive basis Product on such terms as it may, in its sole discretion determine, including without limitation, price, returns, credits and discounts. 6. Term. (a) This Agreement shall become effective on the date this Agreement is signed by both parties, and hereinafter referred to as "Effective Date". This Agreement shall terminate sixty (60) months of Effective Date. Each twelve month period of this Agreement shall be referred to as an "Agreement Year". (b) This Agreement will also terminate in the event either party is in default under this Agreement and such defaulting party fails to cure such default, where cure is possible, within sixty (60) days of its receipt of written notice specifying the reasons for default. (c) In the event that Distributor demonstrates aggressive performance in the marketing and sale of Products, the Parties will negotiate in good faith to extend this Agreement for an Additional sixty (60) months on terms and conditions similar to those contained in this Agreement. (d) In the event of contract termination, Supplier will buy back any Products shipped within the previous ninety (90) days from termination date, provided such Product has been stored properly and the remaining shelf life of such Product is at last ninety (90) days. 7. Agency. This Agreement shall not constitute either party as the agent or legal representative of the other party for any purpose whatsoever. Distributor is not granted any right or authority to create any obligation or responsibility, express or implied in the name of Supplier in any manner whatsoever. 8. Warranty . (a) Supplier hereby warrants that the Products sold and delivered hereunder will perform according to Supplier's published specifications for each particular Product, within the shelf life period indicated for such Product ("Warranty Period"). Distributor shall notify Supplier of any defective Product discovered within the Warranty Period specified herein. Supplier will promptly replace any such defective Product conditional upon the return of the defective Product to Supplier upon request. All shipping costs associated with any such replacement or return of defective Products shall be at Supplier's expense. Supplier shall not be required to replace Products which have been damaged as a result of negligence, overheating, freezing, mishandling, or incorrect titration resulting from any party other than Supplier or its agents. (b) WARRANTY DISCLAIMER. THE WARRANTY SET FORTH IN PARAGRAPH 8(a) ABOVE IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING BUT NOT LIMITED TO ANY IMPLIED WARRANTY OF MERCHANTABILITY OR -3- 4 FITNESS FOR A PARTICULAR PURPOSE. IN NO EVENT SHALL SUPPLIER BE LIABLE UNDER ANY PROVISION OF THIS AGREEMENT FOR ANY PROVISION OF THIS AGREEMENT FOR ANY INCIDENTAL OR CONSEQUENTIAL DAMAGES WITH RESPECT TO THE PRODUCTS PURCHASED OR SUPPLIED HEREUNDER. 9. Quality Assurance/Quality Control. Products sold by Supplier to Distributor pursuant to this Agreement will have undergone the same quality assurance/quality control procedures that Supplier undertakes for Products sold in other markets. In addition, Distributor will perform its own quality control procedure on Products. Such quality control procedures shall be of the same format and depth as applied to Supplier manufactured products. At the time Supplier and Distributor agree to the distribution of an antibody, both supplier and Distributor will make available to each other their quality control procedures and specifications for that particular antibody. Any future changes to the specifications or testing procedures will be communicated to the other party thirty (30) days in advance of implementing a change. 10. Payment by Distributor. Distributor shall pay Supplier for Products purchased pursuant to this Agreement on net thirty (30) day terms. Shipments by Supplier to Distributor's facilities are F.O.B. shipping point, and cost of shipping shall be added to the invoice for Products so shipped. Title shall pass to the Distributor at the time and place of shipment. Payment will be made in U.S. dollars. 11. Indemnity. (a) Supplier shall, at its sole cost and expense, protect, defend and indemnity Distributor and hold it harmless from and against any and all claims, lawsuits, losses, liabilities and damages of any nature (including all costs associated with the defense thereof) arising out of or relating to any patent infringement of a Product subject to this Agreement. With regard to claims of patent infringement resulting sale of Product, Distributor agrees to promptly notify Supplier in writing of the receipt of a Notice of Infringement, or threat thereof. In addition, Distributor shall cooperate with Supplier in all necessary and reasonable ways in the defense of any such suit or proceeding. Supplier shall have the full control of any suit proceeding against Distributor. (b) Distributor shall, at its sole cost and expense protect, defend and indemnify Supplier and hold it harmless from and against any and all claims, lawsuits, losses, liabilities and damages of any nature (including all costs associated with the defense thereof) arising out of or relating to any product liability claim or any other claim relating to a defect of a Product subject to this Agreement which is caused by Distributor's negligence or willful acts. (c) The Distributor and Supplier each agree to give the other prompt notice of the bringing of any action against either or upon obtaining knowledge of any threatened action which either is based on a claim of product liability or defect in a Product subject to this Agreement or of an event which would make it difficult or impossible for one or the other party to perform hereunder. Each party agrees to keep the other informed as to the progress of any such action or threatened action and to cooperate in its defense. 12. Confidentiality. Each of Distributor and Supplier agree to treat as confidential information and to hold in confidence and all information and data pertaining to and/or relating to trade secrets or other information designated in writing as confidential information which is divulged to it by the other, except if it (a) was known to the industry or the public at the time of disclosure to the receiving party or subsequently -4- 5 becomes known to the industry or the public through no fault of the receiving party, or (b) was rightfully obtained by receiving party from a third party who is, at the time such information is divulged to receiving party, under no obligation to disclosing party to hold the same in confidence. In any such instance, only the portion of the information which falls within subsections (a) and (b) above shall be free from the restrictions of confidentiality. 13. Binding Effect. This Agreement shall be binding upon and inure to the benefit of the parties thereto and their respective successors and permitted assigns, but neither this Agreement nor any of the rights, interest or obligations hereunder shall be assigned by either party without the prior written consent of the other. Each party acknowledges that certain Products to be distributed pursuant to this Agreement may from time to time be manufactured and/or offered for sale by subsidiaries or other entitles controlling, controlled by or under common control of Supplier or Distributor. Supplier and Distributor covenant and agree that they will take all such action as may be necessary to cause such persons other than themselves (including parents, subsidiaries, affiliate companies or entities) to comply with the terms of this Agreement as if such other person were substituted as a party hereto. 14. Force Majeure. In the event that any party is prevented, interrupted or delayed in the performance of its obligations hereunder by riots, wars, acts of war, acts of God, fires, floods, accidents, strikes, labor disputes, embargoes, governmental orders or regulations, delays of carriers, lack of transportation facilities, inability to obtain raw materials, curtailment of or failure in obtaining fuel or electrical power, or by any similar occurrence beyond the reasonable control of such party, the said party shall be excused from the performance of its obligations hereunder but only while and to the extent that it is actually so prevented, interrupted and/or delayed. 15. Modification-Waiver. No cancellation, modification amendment, deletion or other change in this Agreement or any provision hereof, or waiver of any right or remedy herein provided, shall be effective for any purpose unless specifically set forth in writing signed by the party to be bound thereby. No waiver of any right in respect of any occurrence or event on one occasion shall be deemed a waiver of such right or remedy in respect of such occurrence or event on any other occasion. 16. Entire Agreement. This Agreement supersedes all other agreements, oral or written, heretofore made with respect to the subject matter hereof and the transactions contemplated hereby and contains the entire agreement of the parties with respect thereto. 17. Controlling Law. All questions concerning the validity and operation of this Agreement and the performance of the obligations imposed upon the parties hereunder will be governed by the laws of the State of Arizona. 18. Notices. All notices, elections and communications required or permitted to be given under this Agreement shall be in writing and will be deemed given five (5) days after deposit in the U.S. mail, as registered or certified mail, return receipt requested, postage prepaid and addressed to the party or by personal delivery at the following address: -5- 6 To Supplier: Novocastra Laboratories Ltd. 24 Claremont Place Newcastle Upon Tyne, NE2 4AA United Kingdom Attn: President To Distributor: Ventana Medical Systems, Inc. 3865 North Business Center Drive Tucson, Arizona 85705 Attn: President 19. Counterparts. This Agreement may be executed in several counterparts, each of which shall be deemed an original hereof. 20. Arbitration. Any controversy, dispute, or questions arising out of or in connection with this Agreement or the underlying relationship of the parties, or the interpretation, performance or non-performance of this Agreement of any breach hereof, shall be determined by arbitration held in Tucson, Arizona, in accordance with the then existing rules of the American Arbitration Association. Any decision or award of such arbitration shall be final, conclusive and binding on the parties hereto. Nothing contained herein shall in any way deprive either party of its right to obtain injunctions or other equitable relief, including preliminary relief pending arbitration. All costs and expenses (including counsel and expert witness fees) associated with any such arbitration shall be paid by the party adjudged by the Arbitrator to be responsible for the costs. Any award rendered by an Arbitrator shall be enforceable in any court of competent jurisdiction. 21. Headings. The Section headings used in this Agreement are for convenience of reference only and shall not affect the construction of this Agreement. IN WITNESS WHEREOF, the parties have executed and delivered this Distribution Agreement as of the day and year first above written. NOVOCASTRA LABORATORIES LTD. By /s/C.H.W. HORNE ------------------------------- Title Managing Director 19/8/92 ---------------------------- VENTANA MEDICAL SYSTEMS, INC. By /s/VICTORIA BANNISTER ------------------------------- Title President 8/11/92 ---------------------------- -6- 7 AGREEMENT made the 9th day of July 1993 BETWEEN NOVOCASTRA LABORATORIES 24 CLAREMONT PLACE, NEWCASTLE UPON TYNE and VENTANA MEDICAL SYSTEMS INC. 3865 NORTH BUSINESS CENTER DRIVE TUCSON, ARIZONA USA whereby it is agreed that (1) VENTANA will grant to NOVOCASTRA the right to market in respect of monoclonal antibody to Leucocyte Common Antigen ( [*] ) for use in the manual immunohistochemistry market. (2) VENTANA retains all rights to the [*] but agrees to license NOVOCASTRA exclusively for use in the manual immunohistochemistry market. These rights shall not be transferable. (3) Payment to VENTANA by NOVOCASTRA will be made as a royalty on the value of sales calculated as the amount paid to NOVOCASTRA by companies, research institutions, hospitals, individuals or any person or persons. (4) The royalty will be set at [*] of the amount paid to NOVOCASTRA [*] value added tax and [*] carriage or other cost associated with delivery. (5) NOVOCASTRA will supply on request details of their accounts relating to [*] and [*] at any time on request to VENTANA or their authorized representative. (6) Royalties will be paid by NOVOCASTRA to VENTANA twice yearly. (7) VENTANA and NOVOCASTRA will at all times keep all information relating to this contract strictly confidential and will impose the same obligation of confidentiality on their employees. (8) NOVOCASTRA will undertake to retain the cell lines in their sole possession and will under no circumstances, distribute the cells to any other person, hospital, research institution or company. (9) NOVOCASTRA will also supply at intervals designated by VENTANA [*]. (10) The agreement will commence on the date of signing by authorized representatives of NOVOCASTRA and VENTANA and remain in effect for 10 years from that date. * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 8 (11) In the event of any change in the corporate structure of shareholding of NOVOCASTRA, for example, partial or complete take-over by another company, then VENTANA will be informed in writing and will have the right to void this agreement with return or destruction of the cell lines, [*] at their discretion. (12) In the event that NOVOCASTRA no longer wish to pursue initiation of marketing, or continue marketing of the [*] then all rights concerning the antibodies will refer to VENTANA and VENTANA will have the right to approach any other company regarding exploitation of the antibodies. (13) VENTANA agrees that during the term of this agreement, licensing will not be granted to any other party at a lower royalty rate than applies to this agreement. (14) Any of the provisions of this Agreement may be varied by agreement in writing between both parties. (15) The intellectual property rights regarding the monoclonal antibodies which are subject to this agreement rest with the originator. As witness the hands of the duly authorized representatives of the parties hereto the day and year first written above. Professor C.H. W. Horne Victoria Bannister, President for: /s/C.H.W. HORNE for: /s/VICTORIA BANNISTER ------------------ ------------------------ NOVOCASTRA LABORATORIES VENTANA MEDICAL SYSTEMS, INC. -2- * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. EX-10.18 7 LJL BIOSYSTEMS TECHMATE 250 PRODUCTION AGREEMENT 1 Exhibit 10.18 BioTek Solutions, Inc. 3865 North Business Center Drive Tucson, AZ 85705 May 1, 1996 Lev J. Leytes President and CEO LJL BioSystems, Inc. 404 Tasman Dr. Sunnyvale, CA 94089 RE: TECHMATE 250/HORIZON Dear Lev: This letter outlines the basis on which BioTek Solutions, Inc. (together with its successor and assigns, "BioTek") will work with LJL in moving the Techmate 250 into volume production. It is intended to replace any prior agreements between the parties. However, in addition to this letter, the paragraphs set forth on attached Exhibit 1 are incorporated herein by reference and made a part hereof. Topics covered include (1) accounting for previous transactions, (2) the basis on which the first 100 Techmate 250 units will be procured, (3) payment terms for those 100 units, (4) engineering changes, (5) pricing for subsequent orders of 100 or 200 Techmate 250 units, (6) manufacturing exclusivity for LJL, and (7) restrictions on LJL. Accounting for Prior Transactions We accept the accounting attached to your March 20, 1996 letter which shows BioTek [*] (the "Settlement Amount") to LJL and LJL [*] in Techmate 250 parts on BioTek's behalf, specifically as follows: Unpaid Phase IV - prior to manufacture $ [*] Unpaid Phase IV - manufacturing transfer $ [*] Parts procured $ [*] Payment already received on first order $ [*] ---------- Total amount due $ [*] =========== This amount will be paid when we issue our purchase order for the first 100 Techmate 250 units. [*] We agree that our auditors (Ernst & Young, Tucson) will talk with your auditors (Price Waterhouse, San Jose) to confirm that LJL has made [*] to LJL vendors for Techmate 250 parts inventory valued by LJL at [*]. LJL will pay the outstanding amounts owed to such vendors for such parts promptly after receiving the invoices for such parts and after the [*] balance referred to above is paid by BioTek to LJL. At the time this letter is executed by the parties, LJL will supply to BioTek a true and correct list of such parts. * CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. 2 Lev. J. Leytes LJL BioSystems, Inc. May 1, 1996 Page 2 Order for the First 100 Units This letter agreement will become effective upon LJL's acceptance in writing of the following items: (1) payment in full of the Settlement Amount; (2) the letter of credit as specified in the Payment Terms section of this letter, and (3) BioTek's [*] Techmate 250's to be manufactured on the following terms and conditions (the "Initial Order"): Construction. The construction of the units will be similar to the [*] recently delivered by LJL to BioTek; i.e., resin cast skins with no clear plastic cover. The units will pass the CE tests listed in Attachment A to this letter and will be manufactured in accordance with Good Manufacturing Practices for medical products as prescribed from time to time by the United States Food and Drug Administration. Pricing. The purchase price for the units will be [*] per unit, less a credit of $380.34 per unit for parts already procured and paid for by BioTek [*]. Shipments. Shipments of the units will commence [*] after we issue a purchase order. The shipping rate for the [*]. Delivery schedule will provide for delivery of all units [*] after receipt of Initial Order. We will advise LJL of the monthly shipping rate for the [*] at the time of the first shipment and provide a firm forecast [*] thereafter. The shipping rate will not fall below [*]. Cover Option. BioTek will have the option of adding a clear plastic injection molded cover, or an opaque cover using an alternative fabrication technology, at anytime. If BioTek, elects to proceed with a clear plastic cover, at the option of BioTek, either LJL and BioTek will work together, or BioTek will work alone, to procure the tool necessary to produce that cover. That tool which the parties estimate will cost an estimated [*] (including applicable LJL fees), will be paid for by BioTek and will be the sole property of BioTek. LJL will add the cover to instruments assembled after the cover becomes available and will charge BioTek for this addition based on reasonable agreed upon pricing. If BioTek elects to add a cover using a different fabrication technology, the parties will work together, in good faith, to procure parts on a cost effective basis. Spare Parts. BioTek, will place an order for spare parts on LJL within 30 days of issuing a purchase order. LJL will supply parts already in inventory and paid for by BioTek without additional charge. Other spare parts will be supplied by LJL to BioTek at LJL's normal parts rates. LJL will cooperate with BioTek in identifying the spare parts necessary. BioTek acknowledges that LJL will start ordering production parts within 24 hours after the receipt of the BioTek's purchase order for the [*] Techmate 250, and that any spare parts which are ordered separate from an order for Techmate 250's, may have to be processed individually, at additional cost to BioTek. LJL will work together with BioTek, however, to minimize the cost of parts orders processed individually. * CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. 3 Lev. J. Leytes LJL BioSystems, Inc. May 1, 1996 Page 3 Software Provided this letter becomes effective, BioTek will have an option to acquire a non-exclusive license to modify (as set forth under Engineering Changes), use in the Techmate 250, reproduce and sublicense to purchasers of the Techmate 250 the then current version of the software code for the Techmate 250, for a [*]. BioTek can exercise this option by sending a written request to LJL and [*]. LJL shall ship the then current version of the software code for the Techmate 250, together with the source code therefor and then current relevant documentation within 15 business days of receiving of BioTek's such request and payment. All materials hereunder will be supplied on an "as is" basis and the form then existing at LJL. Any subsequent software engineering support may be requested by BioTek, and may be provided by LJL upon mutually agreed upon terms. Payment Terms for the Initial Order [*] payable under the Initial Order ([*] calculated by dividing the total purchase order price [*]) will be paid by BioTek over the first 5 months after the issuance of the Initial Order as follows: (1) The amount of [*] from the prior transactions will be paid by BioTek at the time the Initial Order is delivered to LJL; and (2) The amount of [*] in the amount of [*], payable on the 30th, 60th, 90th, 120th, and 150th days after the initial payment under the previous paragraph. Prior to LJL's acceptance of the Initial Order, BioTek will deliver to LJL an irrevocable letter of credit in the form attached hereto as Exhibit 2 issued by Silicon Valley Bank for the benefit of LJL in the amount of [*] to secure the payments referred to in subparagraph (2), above. These progress payments will be credited against invoices on a pro rata basis [*]. Payments for shipped units will be due net 15 days after invoice therefor to BioTek; however, if any of the payments are not received when due, and such failure shall continue for 15 days after written notice to BioTek, at the option of LJL. LJL may require that shipments thereafter be made on a pre-paid basis only. If any invoice is past due for more than 180 days, LJL shall be free to sell to any third party the parts and/or units for which LJL has made non-cancelable purchasing commitments to LJL vendors or that are in LJL's inventory, without notice and without any further obligation to BioTek, and LJL shall have a royalty-free non-exclusive license with the right to grant sublicenses, to use, sell and incorporate into such parts and/or units the BioTek's patented capillary gap technology. This royalty-free license as described above shall extend only to those instruments and/or parts that are either in LJL inventory or for which LJL has made non-cancelable purchasing commitments at the time of BioTek's payment default. Interest on all invoices that are more than [*]. Engineering Changes LJL acknowledges that market considerations may require (a) design changes to the Techmate 250 and/or (b) a shift to an alternative fabrication technology for the skins. LJL further acknowledges that BioTek has significant in-house capability to make engineering changes. Accordingly, LJL agrees that it will: * CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. 4 Lev. J. Leytes LJL BioSystems, Inc. May 1, 1996 Page 4 (1) Work with BioTek, in good faith, to investigate and develop cost estimates for engineer changes. Upon BioTek's written request, LJL will provide BioTek with an investigative quote (an "Investigative Quote") prior to any such work and will only perform such work after BioTek's written approval of the Investigative Quote; and (2) Permit BioTek to make software changes if BioTek determines it is more cost effective to use its own engineering resources rather than LJL'S. In the event BioTek chooses to make any software changes using its own engineering resources, BioTek will then become fully responsible for all regulatory compliance, validation, maintenance and revision control of all Techmate 250 software and for supplying to LJL the latest such revisions to be installed on the Techmate 250 units shipped by LJL. All units supplied by LJL after BioTek makes any such changes shall be supplied on "as is" basis with respect to the software components of such units. BioTek recognizes that any engineering changes it makes may require manufacturing engineering changes. LJL will be responsible for manufacturing engineering changes, but BioTek will be responsible for the cost of such changes at LJL normal rates. Such costs will be reasonable. There will be no changes of any kind unless both parties agree, in writing, on the impact of such changes on budgets for non-recurring engineering costs connected therewith, and for implementing ECN documentation, manufacturing unit costs, inventory scrap and rework costs, shipment schedules and any other implications of such changes. Subsequent Orders Orders will be in [*]. Prices for subsequent orders, provided the same construction methods are used as were employed in the production of the units covered by the Initial Order, without cover, will be as follows: (1) The purchase price per unit for [*]. (2) The purchase price per unit for [*]. This ceiling price may be adjusted upwards at the time each new order is placed based on changes in the Bay Area Cost of Living Index (or other mutually agreed upon published index) since the date of the last order. [*] Notwithstanding the foregoing to the contrary, if a purchase order for Techmate 250 units (a "Additional Cost Order") is placed after the 130th day prior to the last scheduled shipment date under the next prior purchase order for Techmate 250 units, in addition to the foregoing per unit price as part of the pricing for the units supplied under such Additional Cost Order. BioTek will pay LJL for the reasonable set-up costs, if any, incurred by LJL as a result of restarting production of Techmate 250 units. These price ceilings may be moved up or down based on engineering and production changes mutually agreed to by the parties. Payment terms of [*], or multiples thereof, shall be no less favorable to LJL than the Payment Terms for the Initial order. Manufacturing Exclusivity LJL shall continue to have exclusive manufacturing rights for the Techmate 250 for so long as (1) it accepts orders for Techmate 250 units in [*], or multiples thereof, at or below the then applicable price ceiling as described * CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. 5 Lev. J. Leytes LJL BioSystems, Inc. May 1, 1996 Page 5 in the preceding section, (2) it meets the delivery schedules mutually agreed to at the time each order is placed, and (3) the units produced by LJL routinely meet the final test specifications mutually agreed to by the parties. If at any time LJL, through a writing signed by its President, requires BioTek to place an order for Techmate 250 units in quantities of [*], or multiples thereof, or at the price above the then applicable price ceiling as described in the preceding section. LJL's manufacturing exclusivity shall terminate immediately upon receipt by BioTek of LJL's written notification. If LJL does not send to BioTek a notice rejecting any BioTek's purchase order within 15 business days of receipt of such order at LJL such purchase order shall be deemed accepted by LJL, provided the order confirms to all the terms of this letter agreement. Notwithstanding anything to the contrary contained herein, LJL shall be entitled to reject any purchase order whose payment terms are less favorable to LJL than the Payment Terms for the Initial Order without losing LJL's manufacturing exclusivity. If at any time LJL shall fail to comply with the requirements under clauses (2) or (3) above, and such failure shall continue for a period of 180 days after LJL is notified in writing by BioTek of such failure. LJL's exclusivity will terminate immediately after expiration of the above 180 days period. If LJL loses its exclusive manufacturing right, BioTek can either manufacture the instrument itself or move production to a third party. If there is a dispute over the loss of manufacturing rights. the parties agree to have the dispute resolved by an independent arbitrator according to the rules of American Arbitration Association. Restriction on LJL LJL hereby agrees that it will not, at any time during the Restrictive Period (as defined below), manufacture or sell to any party other than BioTek, or an affiliate thereof, immunohistochemistry automated tissue microscope slide stainers, whether or nor similar in design. construction, appearance, specifications, application or performance to the Techmate 250. For purposes hereof, the "Restrictive Period" means the period commencing on the date this letter agreement becomes effective and ending when 12 consecutive calendar months have passed during which BioTek [*] 250 units from LJL (other than as a result of LJL's failure to meet BioTek's purchase orders to LJL), if as of the end of that 12-month period a non-cancelable [*] or more Techmate 250 units calling for delivery over the next 12 months has not then been accepted by LJL. Notwithstanding the foregoing, nothing contained herein shall restrict LJL in any way from incorporating the technology embodied in the Techmate 250 into products other than immunohistochemistry automated tissue microscope slide stainers, including but not limited to nucleic acid - based hybridization slide processors of any kind, and from developing, using, making, having made and selling such products. Nothing contained herein shall be construed to have granted LJL a license under any of BioTek's issued patents, except as contained in the section above titled Payment Terms for the Initial Order. Confidentiality The parties hereto acknowledge that in connection with the supply agreement described in this letter, the parties may furnish to each other in the future, information which is Confidential Information (as defined below). Each party hereby agrees that for a period of three (3) years from the date this letter agreement becomes effective, it will keep confidential, and will cause its employees and agents to keep confidential, all of the Confidential Information of the other party. For purposes hereof, "Confidential Information" of a party means any and all information of that party concerning the Techmate 250 or its business which that party or any of its employees, agents or representatives may furnish to the other party or any of its agents or representatives after the date this letter agreement becomes effective, whether in written or oral form, provided that such information, if oral, is summarized by the disclosing party in writing, marked as Confidential and delivered to the receiving party within ten (10) business days following such oral disclosure, and if written, is marked as Confidential at the time it is disclosed. The term "Confidential Information" of a party does not include, however, information which: (i) becomes generally available to the public other than as a result of a disclosure by the other party, (ii) was rightfully available to the other party on a non-confidential basis prior to disclosure by the party which owns the information or its * CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. 6 Lev. J. Leytes LJL BioSystems, Inc. May 1, 1996 Page 6 employees or agents, or (iii) becomes rightfully available to the other party from a source other than the party which owns the information or its employees or agents. Please indicate LJL's acceptance of this letter agreement by signing and returning the attached copy to me. The term of this letter will be reflected in a manufacturing and supply agreement to be subsequently negotiated and signed by the parties. Until a manufacturing and supply agreement is signed, this letter agreement together with the Attachments and Exhibits hereto, reflects the agreement between the parties. Sincerely. BIOTEK SOLUTIONS, INC. By: /s/ JOHN PATIENCE ------------------------------------ John Patience, as authorized agent Agreed to by LJL BioSystems, Inc. as of this 1st day of May, 1996 By: /s/ LEV J. LEYTES ------------------------- Lev J. Leytes, President 7 MANUFACTURING AND SUPPLY AGREEMENT TERM SHEET 1. FINAL TEST SPECIFICATIONS. 1.1 BioTek has approved the specifications and the Phase III prototype units and has authorized manufacturing. 1.2 Final Test Specifications shall be mutually agreed on based on the test results achieved by the first 10 Pilot Units. In the event that the Pilot Units' performance is substantially equivalent to the Phase III prototypes, all costs associated with requests to modify the Pilot Units or the product design, based on the Pilot Units' testing, shall be borne by BioTek. 1.3 Any subsequent changes in final specifications will be handled by LJL on time and material basis, in a two-step process: investigational quote, then execution quote will be done upon BioTek's approval (follow the LJL Standard Manufacturing and Supply Agreement). 2. DELIVERY AND ACCEPTANCE 2.1 All LJL Products ordered under this Agreement will be shipped F.O.B. Sunnyvale. LJL shall deliver the units to BioTek at the address specified in each order. 2.2 Drop shipment arrangements may be agreed for an additional charge. 2.3 LJL will bill BioTek for shipping, handling. insurance, duties and customs charges incurred in shipping products. 2.4 BioTek shall have the right to inspect and accept or reject any units tendered for delivery within 60 days of delivery if units do not meet Final Test Specifications at initial out of box power-up and fail to be put in service. LJL shall respond (i) with replacement units or replacements parts, at BioTek's sole discretion, within 30 days or (ii) with written notification, if LJL disputes the nonconformance. Disputes unresolved after 30 days will be resolved by an independent testing organization. 3. WARRANTY 3.1 LJL warrants that each unit after the initial shipment of 10 pilot units supplied by LJL to BioTek shall conform to the Final Test Specifications prior to shipment. 8 3.2 Inclusion of warranty can be negotiated on future orders for a corresponding increase in transfer price. 4. RIGHT OF ACCESS. 4.1 BioTek shall have the right, upon reasonable notice and during regular business hours, to observe any manufacturing activity hereunder in progress at LJL's facility. 5. REGULATORY REQUIREMENTS. 5.1 LJL will cooperate with BioTek at BioTek's expense to obtain any applicable regulatory or safety certifications. 6. SERVICE CONTRACTS. 6.1 Service at LJL factory available on time and materials basis. 6.2 Parts for servicing can be made available for purchase. Purchase of service spares is recommended at the time manufacturing orders are placed as some parts have long lead times and including with production volume order will result in lower parts prices (as compared to ordering in low volume separate from a manufacturing order). 6.3 Service contracts can be offered at negotiated price. 6.4 Service training, manuals and documentation can be developed on a project basis with an approved order, budget and down payment 7. CHANGE ORDERS. 7.1 LJL will manufacture the product to meet the Final Test Specifications (subject to section 2). However, the ability of product to perform required functions is the result of BioTek specifications, and accordingly is the responsibility of BioTek and not LJL. 8. PUBLICITY. 8.1 A nameplate with LJL's logo and the words "Manufactured by LJL BioSystems, Inc." will be put on the front of each instrument at the time of manufacture at a mutually agreed, appropriate place and size. 9. GOVERNING LAWS. 9.1 State of California, in the county of residence of party not initiating the action. -2- 9 10. GENERAL. 10.1 None of the provisions may be waived, varied or extended except expressly in writing, and signed by all parties, LJL and BioTek. 10.2 Units being returned to LJL by BioTek must be decontaminated at the expense of BioTek, and certified as such. 11. SALES TAXES. 11.1 BioTek is responsible for all applicable sales taxes. LJL will collect and remit California sales tax, unless a resale card is on file prior to shipment. Sales tax in any other areas will be the responsibility of BioTek to report and pay directly. 11.2 BioTek agrees to pay in a timely manner, any additional California sales and use tax that may be billed at a later date by the State of California. BioTek also agrees to pay all interest charges and penalties. If BioTek and LJL agree that LJL should defend against or appeal such additional state sales and use taxes, BioTek agrees to pay all LJL's expenses associated with such defense or appeal. 12. INDEMNIFICATION. 12.1 Mutual hold harmless clauses for actions of each company's employees or consultants. 12.2 No consequential damages liability. -3- 10 Report No.: 51213-LJL089-CE Attachment A Generic Standard: EN 50081-1:1992 Test Standard: EN 55022:1991 (Class A) Radiated Emissions Results Modifications PASSED None Line Conducted Emissions Results Modifications PASSED None Generic Standard: EN 50082-1:1992 Test Standard IEC 801-2:1984, IEC 801-2:1993 Electrostatic Discharge Results Modifications PASSED -4kV contact, 8kV air discharge None Generic Standard: EN 50082-1:1992 Test Standard: IEC 801-3:1984, pr(pound)N 50140:1993 Radiated RF Immunity Results Modifications PASSED - 3V/M None Generic Standard: EN 50082-1:1992 Test Standard: IEC 801-4:1988, IEC 1000-4-4:1995 Electrical Fast Transient (EFT) Burst Immunity Results Modifications PASSED - 2kV mains None
TABLE 1.3-1: Results Summary/Modification List -4- -----END PRIVACY-ENHANCED MESSAGE-----