-----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, EF7C7t04QZ0o2URsn3DOBFgC0F7pKcHLG7UMZyL7t8SJCWXG/muDojdlnSbknWtt GjqGYZi35PiiXRHx2xoUYw== 0001012870-98-000837.txt : 19980401 0001012870-98-000837.hdr.sgml : 19980401 ACCESSION NUMBER: 0001012870-98-000837 CONFORMED SUBMISSION TYPE: 10-K405 PUBLIC DOCUMENT COUNT: 7 CONFORMED PERIOD OF REPORT: 19971231 FILED AS OF DATE: 19980331 SROS: NASD FILER: COMPANY DATA: COMPANY CONFORMED NAME: APPLIED IMAGING CORP CENTRAL INDEX KEY: 0000816066 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 770120490 STATE OF INCORPORATION: CA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-K405 SEC ACT: SEC FILE NUMBER: 000-21371 FILM NUMBER: 98582870 BUSINESS ADDRESS: STREET 1: 2380 WALSH AVE BLDG B CITY: SANTA CLARA STATE: CA ZIP: 95051 BUSINESS PHONE: 4085620250 MAIL ADDRESS: STREET 1: 2380 WALSH AVE STREET 2: BUILDING B CITY: SANTA CLARA STATE: CA ZIP: 95051 10-K405 1 FORM 10-K405 FOR FISCAL YEAR ENDED 12/31/1997 ================================================================================ UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 --------------- FORM 10-K [X] Annual Report Pursuant to Section 13 or 15 (d) of the Securities Exchange Act of 1934 For the Fiscal Year Ended December 31, 1997 or [_] Transition Report Pursuant to Section 13 or 15 (d) of the Securities Exchange Act of 1934 Commission File Number: 0-21371 APPLIED IMAGING CORP. (Exact name of registrant as specified in its charter) DELAWARE 77-012490 (State or other jurisdiction of (I.R.S. Employer incorporation or organization) (Identification No.) 2380 WALSH AVENUE, Building B, Santa Clara, California 95051 (Address of principal executive offices) (Zip Code) Registrant's telephone number, including area code: (408) 562-0250 Securities registered pursuant to Section 12 (b) of the Act: TITLE OF NAME OF EACH EXCHANGE EACH CLASS ON WHICH REGISTERED --------------- ------------------ None N/A Securities registered pursuant to Section 12 (g) of the Act: COMMON STOCK, $0.001 PAR VALUE (Title of Class) Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports) and (2) has been subject to such filing requirements for the 90 days. Yes [X] No [_] Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of registrant's knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. [X] The aggregate market value of voting stock held by non-affiliates of the registrant, based upon the closing sale price of the Common Stock on March 12, 1998, as reported on the Nasdaq National Market, was approximately $23,487,715. The number of shares of Common Stock outstanding as of March 12, 1998: 7,668,206 shares. DOCUMENTS INCORPORATED BY REFERENCE Part III of this Form 10-K incorporates information by reference from the Registrant's definitive proxy statement to be filed with the Securities and Exchange Commission within 120 days after the close of the fiscal year. ================================================================================ PART I ITEM 1. BUSINESS This Report on Form 10-K contains certain forward looking statements regarding future events with respect to Applied Imaging Corp. Actual events or results may differ materially as a result of the factors described herein and in the documents incorporated herein by reference, including, in particular, those factors described under ''Additional Risk Factors.'' THE COMPANY Applied Imaging Corp (''Applied Imaging'' or the ''Company'') was incorporated in California in July 1986, and reincorporated in Delaware in October 1996. Applied Imaging designs, develops, manufactures and markets automated clinical analysis systems used by cytogenetic laboratories for prenatal and other genetic testing applications. The Company's cytogenetic instrumentation and reagent business, which has sold systems to over 600 sites in more than 35 countries since its inception, markets computer-based microscopic image analysis systems that enable laboratories to automate the analysis of chromosomal abnormalities associated with conditions such as Down Syndrome. The Company is also developing a proprietary genetic screening technology designed to facilitate prenatal screening for genetic abnormalities by isolating ''fetal blood cells'' from a routine maternal blood sample. This new technology is designed to improve current prenatal testing methods by providing a timely and cost-effective screening procedure without the risks of miscarriage or fetal damage associated with invasive prenatal tests such as amniocentesis or chorionic villus sampling. The Company also markets specialized imaging systems used in basic research and pharmaceutical discovery for the real-time analysis of changes in intracellular ion concentrations, a key method for determining the function of biologically- active compounds. Applied Imaging is a leading provider of automated chromosomal image analysis systems to clinical and research laboratories worldwide. The Company's CytoVision karyotyping systems are widely accepted because of their ability to analyze standard human chromosome preparations using powerful software classification algorithms along with a specialized cytogenetic user interface. The CytoVision systems also incorporate the capability to analyze and record images derived from advanced genetic research assays employing fluorescent in situ hybridization (''FISH'') or comparative genomic hybridization (''CGH'') methods. The Company recently announced its first proprietary assay for color chromosome analysis (called RxFISH(TM)), a rapidly developing area of research interest. Based upon a novel method developed by scientists at The University of Cambridge, the Company's RxFISH(TM) assay develops a unique fluorescent color banding pattern for human chromosomes that is then analyzed by the CytoVision software. The future development of specialized reagent products that can be optimized for use on the Company's installed base of over 1100 chromosome analysis workstations worldwide is a key aspect of the Company's business strategy. The Company's prenatal genetic screening development program is focused on the isolation of specific fetal cells from a blood sample taken from the expectant mother using normal venipuncture techniques. This allows prenatal genetic testing to be performed without the need to obtain a fetal tissue sample by an invasive procedure, such as amniocentesis, which can pose a physical risk to the fetus. The Company's proprietary screening technology incorporates (i) a patented hematological procedure to enrich the concentration of fetal blood cells found in maternal blood, (ii) a fetal hemoglobin test kit, (iii) automated image analysis instrumentation to identify fetal blood cells and (iv) third- party DNA probes to identify certain chromosomal abnormalities present in these fetal blood cells. This prenatal screening system is expected to be both safe and accurate because it evaluates actual fetal cells while posing no direct risk to the fetus. The Company's prenatal screening products are currently in preclinical evaluation. In late 1996 and early 1997, the Company submitted three medical device applications to the United States Food and Drug Administration (''FDA'') under section 510(k) of the Federal Food, Drug and Cosmetic Act (''510(k) ''). The first submission was for the Company's ENRICH Kit, a product that enriches the concentration of certain types of cells from whole blood based on the Company's patented hematological techniques. The Company received notification in December of 1997 from the FDA that it may market the ENRICH Kit for these purposes. The second submission was for the automated image analysis instrument which is able to automatically detect and locate nucleated red blood cells on a microscope slide. The instrument presents these cells for operator review and further 1 testing and analysis. The third submission covers the reagents used to identify cells containing fetal hemoglobin so that they may be further characterized. The Company anticipates that sales of its prenatal screening products, if approved by the FDA, will include its proprietary consumable ENRICH Kit, the reagents used to identify fetal hemoglobins and the imaging instrumentation used to analyze the fetal cells. The Company believes that it can utilize its existing infrastructure, worldwide distribution capabilities and extensive cytogenetic laboratory relationships to support the introduction of these prenatal screening products. Furthermore, the Company believes that its new cell enrichment, identification and image analysis products may have clinical utility for cancer testing and the prenatal diagnosis of single gene disorders. GENETIC DISORDERS All genetic information in an organism is contained in its chromosomes, made up of strands of DNA and associated protein molecules. DNA is comprised of paired nucleotide bases and genetic information is encoded by the specific order of the nucleotide bases within units called genes. Genes are organized linearly along the chromosomes and carry the required information for the synthesis of the proteins that provide the structural components of cells and tissues, as well as the enzymes needed for the basic biochemical and physiological functions of the cells. Chromosomal Disorders The nuclei of normal human cells (except sperm and egg cells) contain two sets of 23 different chromosomes, one set provided by each parent. Sperm and egg cells are formed in a special cell division process called meiosis, and they each contain only one set of the 23 individual chromosomes. When these cells unite during fertilization, each contributes its set of 23 chromosomes to the genetic information for a new human fetus, and the fertilized egg then has the two sets of 23 chromosomes. Chromosomal disorders may occur when genes or portions of genes move between chromosomes (chromosomal translocations), when portions of chromosomes and the genes they contain are missing, or when an abnormal number of chromosomes are present in the cell. Certain chromosomal disorders are thought to occur during meiosis when the division of the chromosomes to form the egg cell or the sperm cell takes place. During this process the chromosomes may not divide properly resulting in an extra chromosome being present in the cell, an extra piece of genetic material being attached to a chromosome, or a piece of chromosome being broken. Chromosomes can be seen under a microscope and, when stained with certain dyes, reveal light and dark bands reflecting regional variations in the DNA of the cell. Differences in size and banding pattern allow the chromosomes to be distinguished from each other or may identify a chromosomal disorder. The most common chromosomal disorder, Down Syndrome, also known as trisomy 21, occurs when there are three copies of chromosome 21 in the human cell. Syndromes caused by the most common chromosomal abnormalities may result in mental retardation, impaired physical development and abnormal sexual development. There are approximately four million births in the United States annually. Of these, approximately 90% are to women under the age of 35. The Company estimates that there are approximately 11 million births in industrialized countries where prenatal screening and diagnostic testing is routine. Approximately 2% of newborns have birth defects, approximately 12% of which are caused by chromosomal genetic disorders. The risk of bearing a child with a chromosomal abnormality increases with maternal age and more than doubles from one in 526 births for mothers of age 20 to more than one in 192 births for mothers of age 35. Single Gene Disorders In addition to chromosomal disorders caused by an abnormal number of chromosomes, single gene disorders may occur when the DNA sequences of individual genes are altered, resulting in the disruption of the normal balance or function of essential human proteins. Single gene disorders are responsible for many inherited diseases such as cystic fibrosis, sickle cell anemia and Tay- Sachs disease. 2 Cancer Cytogenetics Chromosomal analysis is also performed for clinical research purposes for the precise characterization of certain types of cancers. Cancerous cells frequently demonstrate complex chromosomal abnormalities. The patterns of these chromosomal abnormalities may be associated with certain well-defined cancers. The chromosomal analysis of leukemia and lymphomas, for example, may provide researchers with supplementary information useful in the staging or classification of the disease and may also provide useful prognostic indicators. Similarly, advanced chromosomal analysis may allow a researcher to assess the sources of new disease in a patient to determine if this is a recurrence of a previous cancer or an entirely different neoplasm. PRENATAL TESTING Prenatal testing is the process of detecting certain types of chromosomal disorders in a fetus at an early stage of pregnancy. Prenatal testing is currently performed either invasively, by extracting fetal cells and inspecting the chromosomes within such cells to diagnose specific disorders or non- invasively, by an analysis of a maternal blood sample. The invasive diagnostic procedures yield accurate results on a broad range of chromosomal disorders because actual fetal cells are obtained and analyzed. However, these procedures involve the risk of spontaneous miscarriage and other complications. Due to the risk of spontaneous miscarriage, invasive diagnostic procedures are usually recommended only to those women who are age 35 or older (at which ages the risk of having a child with a chromosomal disorder is greater than the risk of spontaneous miscarriage due to the procedure) or who have another specific risk factor for fetal abnormalities. Those women younger than 35 are typically screened initially using non- invasive techniques. For this group, an invasive diagnostic procedure is generally recommended only to confirm the result of a non-invasive blood test if such test indicates a heightened risk of a chromosomal disorder. The blood test presents no risk to the fetus, but is less accurate since it does not diagnose chromosomal genetic disorders by direct analysis of fetal cells. These non- invasive tests are known to produce relatively high levels of false negative and false positive test results. A false negative test result is seen as a failure to identify a chromosomal disorder when it is actually present, while a false positive test result occurs when a test result indicates the presence of a chromosomal disorder that is actually not present. Women under the age of 35 have a lower statistical risk of giving birth to an infant with a chromosomal disorder than do women age 35 or older. However, because the majority of all births are among women under the age of 35, the total number of newborns with chromosomal disorders born to women in this age group is much higher than that among women age 35 and older. Consequently, women younger than 35 bear over 75% of all infants with Down Syndrome. Invasive Diagnostic Procedures Amniocentesis. Amniocentesis, usually performed between the 14th and 20th ------------- weeks of pregnancy, is the most common procedure used to obtain fetal cell samples for prenatal genetic testing. In an amniocentesis procedure a small amount of amniotic fluid is withdrawn from the amniotic sac via a long needle inserted through the mother's abdominal wall. During the procedure, the physician typically uses ultrasound to guide the needle in order to minimize potential harm to the unborn child. Once the amniotic sample is extracted, it is forwarded to a cytogenetic laboratory, where the cells are cultured and deposited on a microscope slide. The slide is then examined under a microscope in order to locate and analyze a number of fetal cells in metaphase (undergoing cell division). During metaphase, a cell's chromosomes are individually visible under the microscope. Chromosome analysis without the advantage of an automated imaging system is both tedious and time consuming. Typically, a laboratory technologist scans the slide manually to locate cells in metaphase. Once metaphase cells are found, they are photographed using a camera attached to the microscope. This photograph is then printed and each photographed chromosome is manually cut out of the photograph, arranged in order and pasted on a sheet to show the two sets of 23 chromosomes present in the cell. This visual presentation of the chromosomes is called a karyotype. Alternatively, laboratories may eliminate many of these steps by using an automated image 3 analysis system to scan the slides for cells in metaphase, to automatically classify the chromosomes, to present them on a video display for review and acceptance and to print final karyotype copies. Once the karyotype is completed it is then visually analyzed by a trained geneticist or genetic counselor to determine if any chromosomal abnormalities are present. The processing and analysis of prenatal genetic samples obtained by amniocentesis generally requires seven to 14 days. A significant portion of this time is required to culture the fetal cells for use in the visual karyotype. In the United States, amniocentesis generally costs more than $1,000 for the procedure itself, tissue culture and karyotypic assessment. With an estimated fetal loss rate of approximately 0.5% (one in every 200 procedures) one normal fetus will be lost by spontaneous miscarriage resulting from amniocentesis for every one or two fetuses with chromosomal disorders detected by this procedure for women at age 35. Amniocentesis is the most common and accurate of all prenatal screening procedures. All principal chromosomal disorders can be detected and the Down Syndrome detection rate is greater than 99%. Chorionic Villus Sampling (CVS). CVS, typically performed between the 9th ------------------------------- and 11th weeks of pregnancy, involves the extraction of placental tissue samples, generally through the pregnant woman's cervix. The tissue, which is genetically representative of the fetus, is analyzed in the same manner as the fetal cells obtained by amniocentesis to determine if chromosomal disorders are present. CVS is an alternative to amniocentesis and can be performed earlier in the pregnancy, but poses a risk of miscarriage that is one in every 100 CVS procedures, double that of amniocentesis. CVS is generally as accurate as amniocentesis for detecting chromosomal abnormalities. With an estimated fetal loss rate of approximately 1% (one in every 100 procedures), two normal fetuses will be lost by spontaneous miscarriage resulting from CVS for every one or two fetuses with chromosomal disorders detected by this procedure for women at age 35. Due to its higher associated risk and procedural complexity CVS is used less frequently than amniocentesis for prenatal diagnostic purposes. Non-invasive Screening Procedures In the United States, approximately 2,000,000 pregnant women under the age of 35 are screened each year for chromosomal disorders and other birth defects. Of those screened, a majority are tested using the non-invasive serum tests described below. Alpha-Fetoprotein Test. A common serum prenatal screening test for certain ---------------------- chromosomal disorders involves the analysis of alpha-fetoprotein (''AFP'') in the maternal blood. This test is performed on a standard blood sample taken from the mother that is tested for levels of serum AFP. Down Syndrome and other similar chromosomal disorders are associated with low levels of AFP. Although this serum test is relatively accurate in detecting open neural tube defects (such as spina bifida), studies indicate that the AFP test can detect only 20- 30% of fetuses with Down Syndrome. Triple Test. In recent years, the accuracy of the AFP test has been improved ----------- by combining it with additional blood chemistry tests. This combination is commonly referred to as ''triple marker screening'' or the ''triple test.'' This test identifies Down Syndrome in 60% of the pregnancies where Down Syndrome is present. In 40% of the cases where Down Syndrome is present, this test inaccurately concludes that Down Syndrome is not present (a false negative result). In approximately 5% of the cases, the triple test suggests the presence of a chromosomal disorder where it is not present (a false positive result). Women whose triple test screening results indicate a heightened risk of chromosomal disorder are usually recommended to have an amniocentesis procedure to confirm these results. Due to the high false positive rate associated with the triple test, clinically unnecessary amniocentesis procedures are performed in many cases where no chromosomal disorder exists. Assuming two million serum screening tests per year and a 5% false positive rate, as many as 100,000 unnecessary amniocentesis procedures may be performed on women with healthy fetuses each year in the U.S. In addition, assuming an average cost of $1,000 per amniocentesis, the unnecessary cost to the health care system associated with these false positive triple test results could be as high as $100 million per year. With an estimated fetal loss rate of 0.5%, approximately 500 normal fetuses may be lost each year as a direct result of such unnecessary amniocentesis procedures. 4 Summary The most accurate prenatal testing involves direct analysis of fetal cells, which contain the chromosomes of the fetus. The only routinely available procedures to extract fetal cells in order to examine the fetal chromosomes are invasive and pose risks of injury to the fetus and/or spontaneous miscarriage. The non-invasive serum screening procedures, which do not pose such risks, are much less accurate because they do not allow for the direct examination of fetal chromosomes. The Company believes that there is a significant need for a prenatal testing procedure which would allow direct analysis of the fetal cells without the risks associated with the currently available invasive procedures. Fetal blood cells exist in minute quantities in samples of maternal blood. In contrast to adult red blood cells, many of these fetal red blood cells are nucleated. That is, they contain a nucleus with fetal chromosomes. A number of companies and research groups are attempting to isolate these fetal blood cells for testing through a variety of methods, including immunologically-based separation techniques using monoclonal antibodies, flow cytometry, or magnetic separation techniques. Although the feasibility of genetic analysis of fetal blood cells isolated from maternal blood has been demonstrated, obtaining a sufficient number of fetal blood cells for analysis has been difficult and must be adapted further for routine clinical applications. APPLIED IMAGING'S PRENATAL SCREENING PRODUCTS The Company is developing a prenatal screening test to detect chromosomal abnormalities by identifying fetal blood cells from a routine maternal blood sample. The Company's proprietary screening technology incorporates: (i) a patented hematologically-based procedure to enrich the concentration of fetal blood cells utilizing the Company's consumable enrichment kit, (ii) a fetal hemoglobin identification kit, (iii) automated image analysis instrumentation to identify the fetal blood cells and (iv) the use of third-party DNA probes to identify certain chromosomal disorders present in fetal blood cells. This new approach is designed to improve current prenatal screening procedures by providing an accurate, timely and cost-effective technique without the risks of miscarriage or fetal damage associated with invasive prenatal screening techniques. In contrast to immunologically based procedures to isolate fetal blood cells from maternal blood, the Company is developing a hematologically based procedure for enriching the concentration of fetal blood cells from maternal blood samples. The Company's enrichment process is designed to increase the concentration of fetal blood cells in a maternal sample approximately 10,000 times. The fetal cell enriched sample is then harvested and deposited on a microscope slide. The fetal hemoglobin in the cell is stained using the identification kit to facilitate examination through image analysis. The Company has developed a semi-automated product to automatically identify fetal cells on the slide based on adaptations of the image analysis, pattern recognition, and slide-scanning technologies incorporated in the Company's current cytogenetic products. Once fetal cells are located by the automated scanning system, fluorescent DNA probes are added that specifically bind to certain DNA sequences within the fetal cells indicating the presence or absence of chromosomal disorders. DNA probes can be designed to locate specific chromosomal changes, additions, or deletions that result in genetic disorders. The results of the DNA probe analysis are captured and processed using the Company's automated visualization technology for the detection, analysis, and documentation of the DNA probe results. 5 Clinical/Regulatory Matters The Company believes that a key aspect of its prenatal screening products is the ability to enrich and identify fetal blood cells so that they can be directly analyzed using available DNA probe technology. In December 1996, the Company submitted two 510(k) medical device applications to the FDA. The first submission is for a product that isolates mononuclear cells with the use of a gel gradient separation medium. The product is based on the Company's patented hematological techniques. The Company received notification from the FDA on December 15, 1997 that this product may be marketed in the US and, as labeled, is exempt from further 510(k) premarket notification regulatory requirements. The second submission is for an automated image analysis instrument, which is a general laboratory tool able to automatically detect and locate nucleated red blood cells on a microscope slide. The instrument presents these cells for operator review, further analysis, and eventual use in a diagnostic or screening procedure. The FDA review of this submission is ongoing. In June of 1997, the Company submitted an additional 510(k) notification for the fetal hemoglobin identification kit. The FDA review of this submission is also ongoing. The DNA probe components of the Company's products will require either FDA clearance of a 510(k) with a tier III level of review or FDA approval of a PMA. The Company plans to market its prenatal screening products internationally upon receipt of required regulatory clearances or approvals. Commercialization Strategy The Company's prenatal screening techniques under development are currently expected to be introduced first in Europe and subsequently in the United States and the Pacific Rim, subject to receipt of required clearances or approvals in such jurisdictions. The technology is being designed to initially screen for chromosomal abnormalities resulting in conditions such as Down Syndrome and certain sex chromosome abnormalities such as Turner Syndrome, Klinefelter Syndrome, Triple X Syndrome and certain other conditions. These abnormalities account for a vast majority of the incidence of all birth defects which result from chromosome- based genetic disorders. The proprietary prenatal screening products under development will consist of: (i) a prepackaged kit to enrich the concentration of nucleated fetal red blood cells in the maternal blood sample; (ii) a reagent kit to identify the hemoglobins in fetal cells; (iii) the Company's instrumentation to automate the identification of fetal blood cells and the acquisition and presentation of the DNA probe analysis; and (iv) may or may not include a DNA probe kit that is comprised of DNA probes available from third parties. FUTURE APPLICATIONS OF THE PRENATAL SCREENING PRODUCTS The Company's prenatal screening products are being designed to accommodate various chromosome-specific DNA probes, which are currently commercially available. The Company believes that its fetal cell identification and enrichment technology developed for prenatal screening could have future applications for cancer diagnosis and monitoring via the isolation of tumor cells from bone marrow or peripheral blood and the genetic analysis of such cells. The Company is also developing proprietary uses for its fetal cell isolation method that may facilitate the early detection of single gene disorders such as cystic fibrosis, hemophilia, thalassemia, sickle-cell anemia and Tay-Sachs. If additional funding is obtained, the Company intends to pursue these potential additional applications to leverage its proprietary technology. Because evaluations of future applications are at an early stage, no assurance can be given when, if ever, the Company's fetal cell identification and enrichment technology may facilitate the early detection of single gene disorders or cancers. CURRENT CYTOGENETIC PRODUCTS In the United States, approximately 500,000 total cytogenetic test procedures are performed annually. Cytogenetic testing includes prenatal screening for genetic disorders using amniotic fluid obtained through amniocentesis or fetal tissue samples obtained through CVS. Other cytogenetic testing includes tests for the diagnosis and prognosis of cancerous conditions using bone marrow, blood and tumor samples. The Company currently manufactures, markets and sells its CytoVision family of automated instruments for cytogenetic 6 applications. The Company's primary cytogenetic products are described below. The Company has sold systems to over 600 sites worldwide in more than 35 countries. The Company's primary cytogenetic products currently sell for prices ranging from $30,000 to $125,000, depending upon the instrument's capabilities and final configurations. CytoVision Ultima The CytoVision Ultima is the Company's most comprehensive system for automated chromosome analysis. The Ultima integrates many of the key features of the Company's earlier products into one system capable of automated microscope slide scanning, advanced chromosome analysis, fluorescent image processing and comparative genomic hybridization (CGH) measurements. The Ultima allows laboratories to automatically scan slides in either brightfield or fluorescent modes to locate metaphase cells for chromosome analysis. This eliminates one of the most tedious and time-consuming aspects of cytogenetic analysis: that of manual slide scanning. The system accomplishes this in the background while simultaneously allowing the technologist to process and analyze images previously identified. The Company believes that no other commercially available system for cytogenetic analysis incorporates this same range of features in one integrated package. CytoVision Ultra The CytoVision Ultra is a flexible chromosome analysis system that allows laboratories to customize their imaging system in whatever configuration best suits their particular workflow requirements. The Ultra can be designed around the base Karyotyper system to include satellite workstations, laboratory director review stations, fluorescent DNA probe analysis modules and a variety of peripheral equipment, including high-resolution laser and color printers. The Karyotyper itself consists of computerized image capture and analysis system incorporating pattern recognition and automated chromosome classification algorithms. The system provides automated karyotyping capabilities, automatic separation of touching or overlapping chromosomes (a common occurrence), a variety of user-defined image enhancement features, report annotation capabilities and full screen display options. This system entirely replaces the manual processing of photographic images that previously included photographing individual cells in metaphase, photographic development, the manual "cut-and- paste" of each chromosome, identifying the individual chromosomes, arranging them in order and preparation of the final karyotype report. This manual process may take 30 minutes to one hour of a technologist's time to process an individual sample. The comparable CytoVision process requires only 10 minutes or less of the same technologist's time. The DNA probe analysis module for the CytoVision Ultra utilizes the same imaging equipment to detect and analyze DNA probes that have been applied to cell nuclei. CytoVision systems equipped with the DNA probe analysis option enhance images of often-faint fluorescent DNA probes and provide the operator with a range of optimized analytical tools. The system may also be upgraded to detect genetic amplifications and deletions in tumor cells utilizing a research technique known as comparative genomic hybridization (CGH). CytoVision RxFISH and RxFISH DNA Probe Reagents The newest system offered by the Company consists of a specialized fluorescent image analysis option for the CytoVision Ultra that allows laboratories to process color banded chromosome images developed using the Company's RxFISH research reagent system. This system takes advantage of a novel DNA probe technique for identifying each human chromosome with a unique color bar code that allows the Company's proprietary image analysis software to rapidly and accurately identify specific chromosomes, even in cases containing complex or cryptic rearrangements. The RxFISH system will be packaged with the CytoVision Ultra's DNA probe and CGH analysis modules to create an image analysis system well suited for use in those laboratories specializing in cancer cytogenetics research studies. 7 All of the products in the CytoVision family are compatible and can be integrated into a network with common data management protocols. In addition to its analysis systems, the Company also sells a number of peripherals including a range of high quality printers and image capture workstations. A typical installation will include a number of interconnected CytoVision systems and components. SALES, DISTRIBUTION AND MARKETING The Company currently sells its cytogenetic products to government and private clinical cytogenetic laboratories, hospital laboratories, research institutions, universities and pharmaceutical companies. The Company has sold such systems to over 600 customers in more than 35 countries. These customers utilize the Company's cytogenetic products for prenatal genetic screening as well as for certain cancer research studies. If regulatory clearance or approval is received, the Company initially plans to sell and distribute its prenatal screening products directly and through its established worldwide network of distributors and agents through which it sells and distributes its current products. In North America, the Company sells its cytogenetic products directly to its customers. The North American sales team is comprised of eight sales and application support specialists. Outside of North America, the Company sells its products either directly through local agents who are remunerated on a commission basis or through independent distributors. The Company manages its international sales and distribution activities from Applied Imaging International Ltd., the Company's wholly owned subsidiary located in the United Kingdom. The international sales team is comprised of eight sales and application support individuals, based in the United Kingdom and France. The Applied Imaging International Ltd. sales team supports all distributors and agents upon request. The Company's distributors are located in Australia, Hong Kong, Japan, Italy and South Korea. In addition, the Company has agents selling its cytogenetic products in a number of other countries primarily within Europe, the Middle East and the Pacific Rim. Because the Company's products are technically sophisticated, the Company's sales staff is supported by scientifically qualified and highly trained product specialists. The Company offers an annual maintenance program to its customers through its own support organization. The Company's marketing activities include telemarketing, product advertising and participation in trade shows and product seminars. MANUFACTURING The Company assembles and tests components and subassemblies made by outside vendors to the Company's specifications and manufactures only when it believes significant value can be added. The Company's current products are assembled from a combination of (i) commodity technology components such as computers and monitors, (ii) custom subassemblies, such as automated filter wheels, and (iii) operating systems and application software. Any disruption or delay in the supply of components or custom subassemblies will have a material adverse effect on the Company. While the Company typically uses components and subassemblies that are available from alternate sources, any unanticipated interruption of the supply of these components or subassemblies could require the Company to redesign its products. The Company orders components and subassemblies to forecast and assembles specific configurations on receipt of firm orders. The Company's research, investigational and clinical products are subject to regulation by the FDA and all products are subject to regulation by the U.S. Department of Commerce export controls, primarily as they relate to the associated computers and peripherals. The Company has experienced no material difficulties in obtaining necessary export licenses to date. The Company plans to initially subcontract third parties to manufacture the consumable enrichment kit component of its fetal cell screening technology under development and may ultimately manufacture such components on its own. For clinical trials, the Company will purchase the consumable enrichment kit from a third party contracted to manufacture the kit. The Company has no experience manufacturing such components. The Company may encounter difficulties in scaling up production of the consumable component of its fetal cell screening 8 technology under development or in hiring and training additional personnel to manufacture its consumable enrichment kit products in commercial quantities. Under current law, if the Company manufactures finished devices in the United States, it will be required to comply with the FDA's and the State of California's current GMP regulations. In addition, the FDA and/or the California authorities will inspect the Company's manufacturing facilities on a regular basis to determine such compliance. Failure to comply with applicable FDA or other regulatory requirements can result in fines, injunctions, civil penalties, recalls or seizures of products, total or partial suspensions of production and criminal prosecutions. RESEARCH AND DEVELOPMENT The Company's research and development efforts include various research, product development, clinical evaluation and testing, quality assurance, regulatory and process development activities. The current focus of the Company's research and development efforts is the completion of the development of the Company's prenatal screening products and particularly the initiation of clinical trials. In addition, the Company is analyzing different methods for facilitating image analysis of fetal cell enriched samples. The Company's future research and development efforts are expected to include development of additional applications of the Company's current cytogenetic products and additional applications of the fetal cell screening technology under development. These potential additional applications may include the use of technology developed for fetal cell analysis for the characterization and monitoring of certain cancers and the diagnosis of certain single gene disorders. Development of these applications would require substantial additional funds and will be subject to technological, clinical, regulatory and other risks associated with new medical technologies. There can be no assurance that the Company will develop its prenatal screening products or any other future applications of such technology. Research and development expenses were approximately $7.4 million, $3.7 million and $2.9 million in 1997, 1996, and 1995, respectively. PATENTS AND PROPRIETARY RIGHTS The Company actively seeks, when appropriate, protection for its products and proprietary information by means of United States and foreign patents and trademarks. The Company has one issued United States patent relating to its CytoVision System and has corresponding issued patents in certain European countries. In addition, the Company has three United States patents concerning its technology for enriching the concentration of fetal nucleated red blood cells from maternal blood samples. Corresponding applications were filed through the Patent Cooperation Treaty and preserve for the Company the right to file applications in various countries. The Company relies upon trade secrets, know-how and contractual arrangements to protect certain of its proprietary information and products. The fields of life science instrumentation and genetic screening processes are covered by many issued patents and patent applications. The Company is not currently aware of any patents which it may be infringing; however, patent applications in the United States remain confidential until a patent is issued, and, therefore, the Company's products could infringe patents to be issued in the future. If the Company's technology is determined to use products, processes or other subject matter that is claimed under other existing U.S. or foreign patents, or if other patents claiming subject matter utilized by the Company are issued, such companies may bring infringement actions against the Company. The Company may be required to obtain licenses to patents or proprietary rights of others. There can be no assurance that any such license would be made available or, if available, would be available on commercially acceptable terms. Failure to obtain a required license could prevent the Company from commercializing its products resulting in a material adverse affect on the Company's business, financial condition and results of operations. The Company generally enters into confidentiality agreements with its employees and consultants designed to both protect the Company's confidential information and prevent the disclosure of confidential information of prior employers and other parties. There can, however, be no assurance that the Company's trade secrets or proprietary technology will not become known or be independently developed by competitors in such a manner that the 9 Company has no practical recourse. Certain employees of and consultants to the Company are subject to the terms of confidentiality agreements with respect to proprietary information of their former employers. The failure of these persons to comply with the terms of their agreements could result in assertion of claims against the Company and such persons which, if successful, might restrict their roles within the Company. In 1996, the Company entered into a collaborative research agreement with Leiden University (''Leiden'') in the field of enrichment, isolation and analysis of fetal cells derived from maternal blood. Under the terms of the agreement, the Company has sole ownership of any jointly developed inventions and has an exclusive license to any issued patents owned solely by Leiden. The royalty rate for the exclusive license shall not be more than 5% of associated sales. In 1996, the Company entered into an agreement to acquire an invention for the use of certain antibodies in the identification of fetal cells from maternal blood. The agreement provides for the Company to pay certain expenses associated with obtaining a U.S. patent for the invention and a royalty of not more than 2% of net sales. In October, 1997, the Company entered into an exclusive worldwide licensing agreement with the University of Cambridge for the commercialization of DNA- probe technology recently developed by Cambridge researchers. The technology, known as Cross Species Color Banding, will be utilized by the Company in an effort to develop a range of research test reagents to detect and analyze chromosomal aberrations in various species. The Company expects to develop an initial test kit for color banding analysis of human chromosomes that will be made available for research use. The Company also relies upon trademarks to protect certain of its products, and holds a United States trademark registration for the mark ''CYTOSCAN.'' Registration for this mark and the mark ''CYTOVISION'' are held by the Company in certain foreign jurisdictions. The Company also has certain other trademark rights in the United States and other foreign countries. It is possible that third parties may allege superior rights to one or more of the Company's trademarks, or close variations, for those countries in which the Company is presently conducting business or may do so in the future. The Company's rights to use and register its marks in a given jurisdiction may depend on its rights relative to a third party's rights as governed by the laws of the pertinent country. Factors utilized to determine the relevant rights between parties include priority of the use or registration of the mark, how close the respective marks are in appearance, sound and/or meaning, as well as the goods to which they are applied. It is possible that the Company could be prevented from using or registering its trademarks in certain countries due to a superior third party right. COMPETITION The market for the Company's current cytogenetic products is highly competitive. The Company believes that its primary competitors in this market include Perceptive Scientific Instruments, Inc. (a subsidiary of International Remote Imaging Systems, Inc.), and Vysis Inc. The principal competitive factors in this market are product features offered, ease of use, clarity of output, customer service capabilities, price and installed base. The Company believes it competes favorably with regard to these factors. With respect to its prenatal screening products under development, the Company is aware of other companies that are in the process of developing genetic screening products based on competing technologies designed to specifically isolate fetal blood cells in maternal blood samples. Certain of these companies have greater research and development, marketing and financial resources than the Company. These companies include Genzyme Inc. and Bioseparations Inc. Genzyme, through its Integrated Genetics subsidiary, specializes in providing genetic testing services and Bioseparations is a research-stage company focusing on fetal cell isolation methods. The medical diagnostic and biotechnology industries are subject to intense competition. The Company's fetal cell screening technology, if commercially marketed, will also be subject to intense competition from existing procedures such as the triple test. There can be no assurance that the Company's fetal cell screening technology under development will replace any existing procedures. The Company expects the principal competitive factors in the fetal cell screening market to be risk to the fetus, reliability, accuracy, range of disorders detected, cost savings to health care systems and payers and the price of testing. 10 Certain of the Company's competitors have greater financial and technical resources and production and marketing capabilities than the Company. There can be no assurance that these competitors will not succeed in developing technologies and products that are more effective, easier to use or less expensive than those which are currently offered or being developed by the Company or that would render the Company's technology and products obsolete and noncompetitive. In addition, some of the Company's competitors have significantly greater experience than the Company in conducting clinical investigations of new diagnostic products and in obtaining FDA and other regulatory clearances and approvals of products. Accordingly, the Company's competitors may succeed in developing and obtaining regulatory approvals for such products more rapidly than the Company. GOVERNMENT REGULATION The testing, manufacturing, labeling, distribution, sales, and marketing of the Company's products are subject to government regulation in the United States and in other countries. The Company believes that its future success will be significantly dependent upon commercial sales of its prenatal screening products under development. The Company will not be able to market these products for commercial use in the United States until the Company obtains clearance or approval from the FDA and will not be able to market such products overseas until it meets the safety and quality regulations of each foreign jurisdiction in which the Company seeks to sell such products. In the United States, the Company's products are also subject to regulation by state authorities. The State of California's requirements in this area require registration with the state and compliance with state GMP regulations. Noncompliance with applicable FDA requirements can result in, among other things, fines, injunctions, civil penalties, recall or seizure of products, total or partial suspension of production, distribution, sales, and marketing, refusal of the government to grant approval of a pre-market approval application (''PMA'') or clearance of a 510(k), withdrawal of marketing approvals or clearances, a recommendation by the FDA that the manufacturer or distributor not be permitted to enter into government contracts, and criminal prosecution. In certain circumstances, the FDA also has the authority to order the manufacturer or distributor of a device to repair, replace or refund the cost of the device. Failure to comply with regulatory requirements in the United States or abroad could have a material adverse effect on the Company's business, financial condition, and results of operations. Before a new medical device can be introduced into the market, the manufacturer must obtain FDA clearance of a 510(k) or approval of a PMA, unless the device is exempt from the requirement of such clearance or approval. A 510(k) clearance will be granted if the submitted information establishes that the device is substantially equivalent to a legally marketed Class I or II medical device or to a legally marketed Class III device that does not itself require an approved PMA prior to marketing (''predicate device''). A 510(k) must contain information to support a claim of substantial equivalence, which may include laboratory test results or the results of clinical studies of the device in humans. Commercial distribution of a device for which a 510(k) is required may begin only after the FDA issues a finding that the device is ''substantially equivalent'' to a predicate device. A 510(k) for a device incorporating new technology may be given a tier III level of review, which requires the submission of data from human clinical trials. The FDA is required to review 510(k) submissions within 90 days, but it generally takes from five to twelve months from the date of submission to obtain 510(k) clearance from the FDA; it may take longer and 510(k) clearance may never be obtained. The FDA may determine that a device is not ''substantially equivalent'' to a predicate device, or that additional information is needed before a substantial equivalence determination can be made. If a device is not found by the FDA to be substantially equivalent to a predicate device, the Company may be required to submit a PMA application. A PMA must be supported by valid scientific evidence that typically includes data from preclinical testing and human clinical trials to demonstrate the safety and effectiveness of the device. Upon submission of a PMA, the FDA makes a threshold determination regarding whether the application is sufficiently complete to permit filing for a substantive review. An FDA review of a PMA generally takes one to two years from the date the PMA is accepted for filing, but may take significantly longer if the FDA requires the Company to file any major amendment to the PMA. The review time is often significantly extended by the FDA's asking for additional information. An Advisory Panel, primarily composed of clinicians, is convened to review and evaluate the application and provide recommendations to the FDA regarding whether the PMA should be approved. The FDA is not bound by the recommendations of the Advisory Panel. The FDA also conducts an inspection of the manufacturer's facilities to ensure that the facilities are in compliance with GMP requirements. 11 The Company submitted a protocol for clinical trials of the DNA probe product to the FDA in November of 1996. The Company intends to initiate a multisite, United States and international, clinical trial of the DNA probe component of its prenatal testing technology to detect chromosomal disorders in isolated fetal cells. There can be no assurance regarding the timing or nature of the FDA response regarding the DNA probe related protocol or the timing for the commencement of clinical trials. There can be no assurance that 510(k) clearance for any of the prenatal screening products under development or any other future product or modification of an existing product will be granted or that the clearance process will not be unduly lengthy and subjected to a thorough FDA review. The FDA has stated that the DNA probe product will require at least a 510(k) tier III level of review. Further, in its draft guidance for in vitro diagnostic devices utilizing cytogenetic in situ hybridization technology for the detection of genetic mutations, the FDA states that when such devices are intended for use as a ''stand-alone'' for test reporting based on interphase analysis, they will require a PMA that must be reviewed and approved by the FDA prior to sales, distribution and marketing of these products in the United States. The PMA process is typically more complex, expensive and time consuming than the 510(k) process. While the Company has made determinations regarding the appropriate form of approval, if any, required for its products, there can be no assurance that such determinations are correct, that the FDA will concur with such determinations or that such determinations may not be altered due to new interpretations or new data that may become available or changes in the FDA's policies. Export sales of investigational devices that are subject to PMA or investigational device exemption application requirements and have not received FDA marketing approval generally may be subject to FDA export permit requirements depending upon, among other things, the purpose of the export (investigational or commercial), the country to which the device is intended for export, and on whether the device has valid marketing authorization in a country listed in the FDA Export Reform and Enhancement Act of 1996. In order to obtain such a permit, when one is required, the Company must provide the FDA with documentation from the medical device regulatory authority of the country in which the purchaser is located, stating that the device has the approval of the country. In addition, the FDA must find that exportation of the device is not contrary to the public health and safety of the country in order for the Company to obtain the permit. In addition to domestic regulation of medical devices, the Company's current products and its products under development are subject to corresponding regulations governing safety processes, manufacturing processes and quality in foreign jurisdictions in which it operates or such products are sold. The sale of the fetal cell screening products under development may be materially affected by the policies of regulatory bodies or the domestic politics of the countries involved. There can be no assurance that an early prenatal screening test for genetic disorders will not be prohibited or restricted in some jurisdictions. In addition, FDA export permits may be required for shipment of the Company's fetal cell screening products under development to certain foreign countries. Failure to comply with applicable regulatory requirements can, among other consequences, result in fines, injunctions, civil penalties, suspensions or loss of regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution. In addition, future governmental regulations may be established that could prevent or delay regulatory approval of the Company's products. The regulation of medical devices in a number of such jurisdictions continues to develop and there can be no assurance that new laws or regulations will not have a material adverse effect on the Company's business. The European Community and its member countries currently are imposing more substantial regulation on in vitro diagnostic devices and equipment-like medical devices, and such regulation may affect the Company's current products and products under development. Delays in receipt of clearances or approvals to market its products, failure to receive these clearances or approvals, the loss of previously received clearances or approvals or the determination that 510(k) clearance, pre-market approval or other approval is required for a product being marketed without such clearance or approval could have a material adverse effect on the Company's business, financial condition and results of operations. In addition, laboratories who purchase the Company's current products and/or the prenatal screening products under development could be subject to the Clinical Laboratory Improvement Amendments of 1988 (''CLIA''), which are intended to ensure the quality and reliability of medical testing conducted in laboratories in the United States. The Company's products should comply with CLIA regulations or the Company's ability to market its products could be negatively affected. 12 Marketed devices are subject to pervasive and continuing regulatory oversight by the FDA and other agencies, including record-keeping requirements and reporting of adverse experiences with the use of the device. Device manufacturers are required to register their establishments and list their devices with the FDA and certain state agencies. The Federal Food, Drug and Cosmetic Act and certain state laws require that medical devices be manufactured in accordance with GMP regulations. Manufacturing facilities are subject to periodic inspection by the FDA and certain state agencies on a periodic basis to monitor compliance with GMP and other requirements. If violations of the applicable regulations are noted during such inspections of manufacturing facilities, the Company can be prohibited from conducting further manufacturing, distribution and sale of the devices until the violations are cured. The Company is also subject to other federal, state, local and foreign laws, regulations and recommendations relating to safe working conditions and good laboratory practices. The extent of government regulation that might result from any future legislation or administrative action cannot be accurately predicted. Failure to comply with any federal or state regulatory requirements could have a material adverse effect on the Company's business, financial condition and results of operations. THIRD-PARTY REIMBURSEMENT AND HEALTH CARE REFORM In the United States, the Company's products are purchased primarily by medical institutions which then bill various third-party payors, such as Medicare, Medicaid, other government programs and private insurance plans ("Third-Party Payors") for the health care services provided to their patients. Third-Party Payors may deny reimbursement if they determine that the device used in a treatment was unnecessary, inappropriate, experimental or investigational, used for a non-approved indication, or not cost-effective and typically do not reimburse for devices used for research and investigational purposes. Accordingly, physicians must determine that the new clinical benefits of genetic screening procedures justify the additional cost. The market for the Company's current cytogenetic products could be adversely affected by changes in governmental and private third-party payors' policies and the market for the Company's fetal cell screening technology under development could be materially adversely effected by the failure of governmental and Third-Party Payors adopting policies to reimburse health care providers for the use of the Company's fetal cell screening technology under development. The unavailability of third-party coverage or the inadequacy of the reimbursement for medical procedures using the Company's products would adversely affect the Company's business, financial condition and results of operations. In both the United States and internationally, Third-Party Payors are increasingly challenging the prices charged for medical products and services. There can be no assurance that reimbursement for the procedures using the Company's products will be available or, if currently available, will continue to be available, or that future reimbursement policies of payors will not adversely affect the Company's ability to sell its products on a profitable basis. In addition, there can be no assurance that third-party reimbursement will be available for diagnostic procedures based on the Company's prenatal screening products under development. The levels of revenues and profitability of medical device companies may be affected by the continuing efforts of governmental and Third-Party Payors to contain or reduce the costs of health care through various means. In the United States, there have been, and the Company expects that there will continue to be, a number of federal and state proposals to implement government regulation of health care costs. It is uncertain what legislative proposals will be adopted or what actions federal, state or private payers for health care goods and services may take in response to any health care reform proposals or legislation. The Company cannot predict the effect health care reforms may have on its business, and no assurance can be given that any such reforms will not have a material adverse effect on the Company's business, financial condition and results of operations. Further, to the extent that such proposals or reforms have a material adverse effect on the business, financial condition and profitability of the clinical and research laboratories, hospitals and other institutions that comprise the Company's customer base, the Company's business, financial condition and results of operations could be adversely affected. 13 PRODUCT LIABILITY AND INSURANCE The Company's business may involve the risk of product liability claims, including those relating to inaccurate results from its screening products. Although the Company has not experienced any product liability claims to date, any such claims could have a material adverse impact on the Company. The Company maintains product liability insurance at coverage levels which it deems commercially reasonable; however, there can be no assurance that product liability or other claims will not exceed such insurance coverage limits or that such insurance will continue to be available on commercially acceptable terms, or at all. The Company intends to evaluate, depending on the circumstances that exist at the time, whether or not to obtain any additional product liability insurance coverage prior to the time that the Company engages in any extensive marketing of its fetal cell screening technology under development. Even if the Company obtains additional product liability insurance, there can be no assurance that it would prove adequate or that a product liability claim, insured or uninsured, would not have a material adverse effect on the Company's business, financial condition and results of operations. Even if a product liability claim is not successful, the time and expense of defending against such a claim may adversely affect the Company's business, financial condition and results of operations. EMPLOYEES As of December 31, 1997, the Company had 107 employees, of whom 46 were involved in research and development, 9 in manufacturing and manufacturing engineering, 37 in sales, marketing and customer service and 15 in finance and administration. As of December 31, 1997, 43 of the employees were based in the United Kingdom, 61 in the United States, 1 in Israel, and 2 in France. A total of 12 employees hold Ph.Ds, and 2 employees are M.D.'s. The Company's employees include a number of professional cytogeneticists who support and sell its product range. The Company believes its relationship with its employees to be good. ADDITIONAL RISK FACTORS PRENATAL SCREENING PRODUCTS IN EARLY STAGE OF DEVELOPMENT; NO ASSURANCE OF SUCCESSFUL DEVELOPMENT OR COMMERCIALIZATION The Company's prenatal screening products are in an early stage of development and testing. The isolation, identification, enrichment and analysis of fetal cells from a maternal blood sample is difficult and poses a significant technical challenge due to their rarity in maternal blood. The Company has not yet determined how many fetal cells, if any, can be routinely obtained using its process. In addition, fetal cells that circulate in maternal blood are not yet completely understood in terms of their variety and characteristics, such as longevity in maternal blood and fragility when exposed to various processes to enrich their concentration in a maternal blood sample. The Company has, and continues to, refine its processes and test reformulated enrichment media to determine if concentrations of fetal cells can be increased, but there can be no assurance that these efforts will prove successful. In addition, there can be no assurance that the Company's prenatal screening products will be able to detect fetal cells in amounts sufficient to allow for the detection and analysis of chromosomal abnormalities. There can be no assurance that the Company's prenatal screening products will be able to effectively and accurately detect Down Syndrome or other chromosomal abnormalities. The development and potential commercialization of the Company's prenatal screening products will require significant research and development, substantial investment and clinical testing and regulatory clearances or approvals. The Company plans to continue to conduct preclinical testing in order to analyze the feasibility of its prenatal screening products. Such efforts may disclose significant technical obstacles that need to be overcome prior to pursuing clinical trials and seeking necessary regulatory approvals. Such obstacles could have the effect of delaying or preventing the successful development of the Company's prenatal screening products. There can be no assurance that the Company will be able to develop this technology into reliable and effective prenatal screening products, that required regulatory clearances or approvals for commercialization will be obtained in a timely manner, or at all, or that the Company's prenatal screening products or other products under development, if introduced commercially, will be successful. If the Company is unable to successfully develop and market its prenatal screening products, the Company's business, financial condition and results of operations would be materially and adversely affected. 14 LACK OF CLINICAL DATA The Company has conducted no clinical trials of its prenatal screening products pursuant to FDA reviewed protocols. There can be no assurance that the Company will commence such clinical testing, or once commenced, that such testing can be completed successfully within the Company's expected time frame and budget, if at all, or that the Company's products will prove to be reliable and effective in clinical trials. If clinical trials are initiated, such trials may disclose significant technical obstacles having the effect of delaying or preventing the development, testing, regulatory approval and commercialization of the Company's prenatal screening products. There can be no assurance that the results of such clinical trials will be consistent with the Company's limited preclinical results to date or would be sufficient to obtain regulatory clearance or approval or clinical acceptance. If the Company is unable to initiate and conclude successfully clinical trials of its prenatal screening products, the Company's business, financial condition and results of operations would be materially and adversely affected. NO ASSURANCE OF CLINICAL ACCEPTANCE The isolation of fetal cells from maternal blood is a new and novel development. The clinical acceptance of the Company's prenatal screening products will depend upon its acceptance by the medical community and third- party payors as clinically useful, reliable, accurate, and cost-effective compared to existing and future procedures. Clinical acceptance will depend on numerous factors, including the establishment of the product's ability to isolate sufficient numbers of fetal cells during the early stages of pregnancy, to adequately enrich the concentration of nucleated fetal cells, and to reliably analyze and detect the presence of chromosomal abnormalities. Clinical acceptance will also depend on the receipt of regulatory clearances in the United States and internationally, the availability of third-party reimbursement and the Company's ability to adequately train laboratory technicians and cytogeneticists on how to use the prenatal screening products. In addition, there can be no assurance that the Company's prenatal screening products will be a preferable alternative to existing procedures such as the maternal AFP test or the triple test which detect neural tube defects in addition to chromosomal abnormalities, or that the prenatal screening products will not be rendered obsolete or noncompetitive by products under development by other companies. The Company's products are intended to initially screen for Down Syndrome and may not compete favorably with widely accepted methodologies such as amniocentesis or CVS that are highly accurate and diagnose a broader range of abnormalities from one sample of fetal cells. Patient acceptance of the Company's prenatal testing products will depend in part upon physician recommendations as well as other factors, including the effectiveness and reliability of the procedure as compared to amniocentesis, CVS and serum marker procedures. Even if the Company's prenatal screening products are clinically adopted, physicians may elect not to recommend the procedure unless acceptable reimbursement from health care payors is available. There can be no assurance that the Company's prenatal screening products under development will be accepted by the medical community or that market demand for such products will be sufficient to allow the Company to achieve profitable operations. Failure of the Company's prenatal screening procedure, for whatever reason, to achieve significant clinical adoption or failure of the Company's products to achieve any significant market acceptance would have a material adverse effect on the Company's business, financial condition and results of operations. ACCUMULATED DEFICIT; FUTURE LOSSES From its inception in July 1986 through the end of 1997, the Company has generated an accumulated deficit of approximately $19.5 million. The Company expects its operating losses to continue to increase as it continues its efforts to develop and test its prenatal screening products. There can be no assurance that its prenatal screening products under development will be commercially marketed or, if commercially marketed, that the Company will ever receive sufficient revenue to achieve profitability and failure to do so would have a material adverse effect on the Company's business, financial condition and results of operations. 15 QUARTERLY FLUCTUATIONS The Company has experienced and expects to continue to experience significant fluctuations in its quarterly operating results. Factors which may have an influence on the Company's operating results in a particular quarter include (i) demand for the Company's products, new product introductions by the Company or its competitors or transitions to new products; (ii) the results of preclinical or planned clinical trials and, if ever received, the timing of regulatory and third-party reimbursement approvals; (iii) the timing of orders and shipments; (iv) the mix of sales between distributors and the Company's direct sales force; (iv) competition, including pricing pressures; (v) the timing and amount of research and development expenses, including clinical trial-related expenditures; (vi) seasonal factors; (vii) foreign currency fluctuation; and (viii) the delay between incurrence of expenses to develop new products, including related marketing and service capabilities, and realization of benefits from such efforts. The Company typically has experienced increased sales in its first and fourth quarter. The Company believes this pattern of fluctuating revenues reflects the budgetary spending practices of the Company's customer base which consists primarily of public and private cytogenetic laboratories, research organizations and hospitals operating on annual budgets. There can be no assurance that this trend will continue. In addition, currency devaluations and slower economic growth in Asia are expected to decrease demand for the Company's products in Asian markets. Due to all the foregoing factors, it is likely that in some future quarter the Company's operating results will be below the expectations of public market analysts and investors. In such event, the price of the Company's Common Stock would likely be materially adversely affected. ADDITIONAL CAPITAL REQUIREMENTS; NO ASSURANCE FUTURE CAPITAL WILL BE AVAILABLE The Company has expended and will continue to expend substantial funds for research and development, preclinical testing, planned clinical investigations, capital expenditures, and manufacturing and marketing of its products. The timing and amount of spending of such capital resources cannot be accurately determined at this time and will depend upon several factors, including the progress of its research and development efforts and planned clinical investigations, competing technological and market developments, commercialization of products currently under development, and market acceptance and demand for the Company's products. To the extent required, the Company may seek to obtain additional funds through equity or debt financing, collaborative or other arrangements with other companies and from other sources. If additional funds are raised by issuing equity securities, further dilution to stockholders could occur. There can be no assurance that additional financing will be available when needed or on terms acceptable to the Company. If adequate funds are not available, the Company could be required to delay development or commercialization of certain of its products, to license to third parties the rights to commercialize certain products or technologies that the Company would otherwise seek to commercialize for itself, or to reduce the marketing, customer support or other resources devoted to certain of its products each of which could have a material adverse effect on the Company's business, financial condition and results of operations. DEPENDENCE ON PRENATAL SCREENING PRODUCTS; RAPID TECHNOLOGICAL CHANGE AND RISK OF TECHNOLOGICAL OBSOLESCENCE The Company is dependent on the successful development and commercialization of the Company's prenatal screening products. Unfavorable preclinical or clinical results, failure to obtain regulatory clearances or approvals in a timely manner, or at all, or failure to gain widespread market acceptance for the products would have a material adverse effect on the Company's business, financial condition and results of operations. The medical device industry, particularly the prenatal testing, diagnostic, and screening markets, is characterized by rapid and significant technological change. The sale of the Company's current products is largely dependent upon the continued use of prenatal testing methodologies that require the location of fetal cells in metaphase and the karyotyping of chromosomes identified in the metaphase cells. In addition, the Company's current products require a testing laboratory to make a large one-time investment, and the availability of less expensive automated cytogenetic equipment could have a material adverse effect on the Company's business financial condition, and results of operations. The Company's future success will depend in large part on the Company's ability to continue to respond to such changes. There can be no assurance that the Company will be able to respond to such changes or that new or improved competing products will not be developed that render the 16 Company's products obsolete. Product research and development will require substantial expenditures and will be subject to inherent risks, and there can be no assurance that the Company will be successful in developing products that have the characteristics necessary to screen or diagnose particular indications or that any new product introduced will receive regulatory clearance or approval or will be successfully commercialized. UNCERTAINTY OF FDA OR OTHER REGULATORY CLEARANCES OR APPROVALS The testing, manufacturing, labeling, distribution, sale, and marketing, of the Company's products are subject to government regulation in the United States and other countries. The Company's future success will be significantly dependent upon commercial sales of its prenatal screening products under development. The Company will not be able to market these prenatal screening products for commercial use in the United States until the Company obtains clearance or approval from the United States Food and Drug Administration (''FDA'') for each device and will not be able to market such products overseas until it meets the safety and quality regulations of each foreign jurisdiction in which the Company seeks to sell such products. Noncompliance with applicable FDA requirements can result in severe administrative, civil and criminal sanctions. The Company's Cytoscan products were marketed until 1994 in the United States pursuant to pre-market notifications to the FDA under Section 510(k) of the Federal Food, Drug and Cosmetic Act (''510(k)''). A 510(k) pre-market notification must be supported by appropriate data establishing, to the satisfaction of the FDA, that a newly developed device is ''substantially equivalent'' to a legally marketed device that does not itself require FDA approval of a PMA. The Company's CytoVision product is the current model of the Cytoscan product, marketed pursuant to the original 510(k) filing. The Company has applied for three separate 510(k) clearances for the enrichment product, automated scanning product and the Fetal Hemoglobin Identification Kit. The Company has been notified by the FDA that the enrichment product may be marketed in the U.S. The DNA probe product will require either FDA clearance of a 510(k) with a tier III level of review or a PMA. The Company submitted a protocol for clinical trials of the DNA probe product to the FDA in November of 1996. The Company intends to initiate a multisite, U.S. and international, clinical trial of the DNA probe product to detect chromosomal disorders in isolated fetal cells during 1998, based upon the review of the protocol by the FDA. There can be no assurance regarding the timing or nature of the FDA response regarding the DNA probe related protocol or the timing for the commencement of clinical trials. There can be no assurance that 510(k) clearance for any of the Company's products under development or any other future product or modification of an existing product will be granted or that the clearance process will not be unduly lengthy and subjected to a thorough FDA review. The FDA has stated that the DNA probe product will require at least a 510(k) tier III level of review. Further, in its draft guidance for in vitro diagnostic devices utilizing cytogenetic in situ hybridization technology for the detection of genetic mutations, the FDA states that when such devices are intended for use as a ''stand-alone'' for test reporting based on interphase analysis, they will require a PMA that must be reviewed and approved by the FDA prior to sales, distribution and marketing of these products in the United States. The regulation of medical devices continues to develop and there can be no assurance that new laws or regulations will not have a material adverse effect on the Company's business, financial condition and results of operations. Delays in receipt of clearance or approvals to market its products, failure to receive these clearances or approvals, the loss of previously received clearances or approvals, the determination that 510(k) clearance, pre-market approval or other approval is required for a product being marketed without such clearance or approval, or failure to comply with existing or future regulatory requirements could have a material adverse effect on the Company's business, financial condition and results of operations. 17 NEED TO COMPLY WITH INTERNATIONAL GOVERNMENT REGULATION The regulatory review process varies from country to country. Currently, the Company's products are subject to pre-market approval in several of the countries that are members of the European Union (''EU'') and subject to other regulatory requirements in those and other countries. In addition, the regulation of in vitro diagnostic devices (''IVDs'') and other medical devices continues to change. The Company may rely, in some circumstances, on its international distributors for compliance with regulatory requirements in those countries where the Company intends to use distributors. Any enforcement action by regulatory authorities with respect to regulatory noncompliance may have a material adverse effect on the Company's business, financial condition and results of operations. The time required to obtain approval for sale in foreign countries may be longer or shorter than that required for FDA clearance and the requirements may differ. In addition, there may be foreign regulatory barriers other than approval for sale. The Company plans to bring its instruments, when required, into compliance with the European Parliament's Electromagnetic Compatibility Directive (89/336/EEC) (the ''ECD'') and to be entitled to apply the CE mark, with respect to the ECD, to its instruments. The European Parliament has made a distinction between Medical Devices (''MDs'') and IVDs. The Company's instruments are not now subject to the requirements or advantages of the Medical Device Directive (93/42/EEC). There can be no assurance, however, that some or all of the Company's products will not be redefined as M.D.'s and made subject to this Directive by the EU or its member states, which may have a material adverse effect on the Company's business, financial condition, and results of operations. There can be no assurance, moreover, that member states, or any other European country, will not adopt other statutes or regulations that require approval to sale the Company products, or that will otherwise have a material adverse effect on the Company's business, financial condition, or results of operations. DEPENDENCE UPON PATENTS AND PROPRIETARY TECHNOLOGY; RISK OF INFRINGEMENT The Company relies on trade secret protection and on its unpatented proprietary know-how in the development and manufacturing of its products. There can be no assurance that the Company's trade secrets or proprietary technology will not become known or be independently developed by competitors in such a manner that the Company has no practical recourse. Nor can there be any assurance that others will not develop or acquire equivalent expertise or develop products that render the Company's current or future products noncompetitive or obsolete. There can be no assurance that the claims allowed under its patents will be sufficiently broad to protect what the Company believes to be its proprietary rights. In addition, there can be no assurance that issued patents will not be disallowed or circumvented by competitors, or that the rights granted thereunder will provide competitive advantages to the Company. Companies have filed applications for, or have been issued patents relating to, products or processes that may be competitive with certain of the Company's products or processes. The Company is unable to predict how the courts would resolve issues relating to the validity and scope of such patents. The validity and breadth of claims in medical technology patents involve complex legal and factual questions and, therefore, may be highly uncertain. No assurance can be given that any issued patent or patents based on pending patent applications or any future patent application will exclude competitors, that any of the Company's patents in which it has licensed rights will be held valid if subsequently challenged or that others will not claim rights in or ownership of the patents and other proprietary rights held or licensed by the Company. Furthermore, no assurance can be given that others have not developed or will not develop similar products, duplicate any of the Company's products or design around any patents issued to or licensed by the Company or that may be issued in the future to the Company. Since patent applications in the United States are maintained in secrecy until patents issue, the Company also cannot be certain that others did not first file applications for inventions covered by the Company's pending patent applications, nor can the Company be certain that it will not infringe any patents that may issue to others on such applications. 18 In addition, patent applications in foreign countries are maintained in secrecy for a period after filing. Publication of discoveries in the scientific or patent literature tends to lag behind actual discoveries and the filing of related patent applications. The Company has not conducted an extensive search of patents issued to other companies, research or academic institutions, or others, and no assurances can be given that such patents do not exist, have not been filed, or could not be filed or issued, which contain claims relating to the Company's technology, products or processes. Patents issued and patent applications filed in the United States or internationally relating to medical devices are numerous and there can be no assurance that current and potential competitors and other third parties have not filed or in the future will not file applications for, or have not received or in the future will not receive, patents or obtain additional proprietary rights relating to products or processes used or proposed to be used by the Company. There are pending applications, which if issued with claims in their present form, might provide proprietary rights to third parties relating to products or processes used or proposed to be used by the Company. The Company may be required to obtain licenses to patents or proprietary rights of others. The medical device industry in general, and the industry segment that includes products for prenatal diagnostic screening in particular, have been characterized by substantial competition. Litigation regarding patent and other intellectual property rights, whether with or without merit, could be time consuming and expensive to respond to and could divert the Company's technical and management personnel. The Company may be involved in litigation to defend against claims of infringement by the Company, to enforce patents issued to the Company, or to protect trade secrets of the Company. If any relevant claims of third-party patents are held as infringed and not invalid in any litigation or administrative proceeding, 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 such patent, or to redesign its products or processes to avoid infringement. In addition, in the event of any possible infringement, there can be no assurance that the Company would be successful in any attempt to redesign its products or processes to avoid such infringement. Accordingly, an adverse determination in a judicial or administrative proceeding or failure to obtain necessary licenses could prevent the Company from manufacturing and selling its products, which would have a material adverse effect on the Company's business, financial condition and results of operations. Costly and time-consuming litigation brought by the Company may be necessary to enforce patents issued to the Company, to protect trade secrets or know-how owned by the Company, or to determine the enforceability, scope and validity of the proprietary rights of others. LIMITED MANUFACTURING EXPERIENCE; NO MANUFACTURING EXPERIENCE FOR THE CONSUMABLE ENRICHMENT KIT To date, the Company's manufacturing activities have consisted primarily of the assembly and testing of its cytogenetic products. If the Company obtains necessary regulatory clearances, registrations and approvals for its prenatal screening products and such technology is successfully introduced, the Company will be required to increase its manufacturing capacity. The Company has no experience in manufacturing the consumable enrichment kit or fetal hemoglobin identification kit portions of its prenatal screening products. Manufacturers often encounter difficulties in commencing and increasing production, including problems involving production yields, adequate supplies of components, quality control and assurance (including failure to comply with the FDA's and State of California's GMP regulations, international quality standards and other regulatory requirements) and shortages of qualified personnel. Difficulties experienced by the Company in manufacturing could have a material adverse effect on its business, financial condition and results of operations. There can be no assurance that the Company will be successful in commencing manufacture of the prenatal screening products in commercial quantities, increasing manufacturing capacity or that it will not experience manufacturing difficulties or product recalls in the future. NEED TO MANAGE GROWTH Significant future growth in the Company's sales and expansion in the scope of its operations, should they occur, may place considerable strain on the Company's management, financial, manufacturing and other capabilities, procedures and controls. There can be no assurance that any existing or additional capabilities, procedures or controls will be adequate to support the Company's operations or that its capabilities, procedures or controls will be designed, implemented or improved in a timely and cost-effective manner. Failure to implement, improve and 19 expand such capabilities, procedures and controls in an efficient manner at an appropriate pace could have a material adverse effect on the Company's business, financial condition and results of operations. SINGLE SOURCE COMPONENTS; DEPENDENCE ON KEY DISTRIBUTORS Certain components of the Company's prenatal screening products under development are expected to be in consumable enrichment kit form. The Company intends to initially subcontract the manufacture of such consumable enrichment kits; however, given the stage of the product's development, neither internal nor third party manufacturing processes have been established. The Company currently relies on a sole supplier for a certain component of its consumable enrichment kit. There can be no assurance that reliable, high volume commercial supplies of such component can be established at commercially reasonable costs or that a new supplier could be qualified in a timely manner if the supply of such component were interrupted. There can be no assurance that reliable high volume manufacturing of such gradients can be established at commercially reasonable costs or that a new supplier could be qualified in a timely manner if the supply of such gradients were interrupted. In addition, the Company proposes to use DNA probes in a prenatal screening kit under development, which are currently provided by a limited number of vendors. The Company purchases certain types of DNA probes from a particular supplier subject to such supplier meeting various performance standards. Such probes require FDA clearance or approval for marketing for clinical diagnostic procedures in the United States and may require FDA approval for export. The DNA probe market is characterized by extensive patent litigation and any court order with respect to infringement of intellectual property could adversely affect the supply of available and cost-effective DNA probes. While the Company believes that other sources for such DNA probes are available, if there were to be interruptions in obtaining supplies from its present source, the Company would have to qualify new sources of approved supply. Outside of North America and the United Kingdom, the Company relies substantially on independent distributors and sales agents to market and sell its products. There can be no assurance that distributors and agents will devote adequate resources to support sales of the Company's products. Moreover, agreements with a number of its distributors require that the Company indemnify such distributors against costs, expenses and liabilities relating to litigation regarding the Company's products and, despite these obligations of the Company, distributors may decide to reduce or end their selling efforts until an infringement dispute is resolved or settled. RELIANCE ON INTERNATIONAL SALES AND OPERATIONS The Company has significant international operations based in the United Kingdom employing at December 31, 1997, approximately 43 employees. In 1997, 1996, and 1995, approximately 59%, 60% and 61% respectively, of the Company's total revenues were derived from customers and distributors outside of the United States and Canada. Until such time, if ever, as the FDA clears or approves the Company's fetal cell screening technology for marketing in the United States, the Company expects that international sales of cytogenetic products will continue to account for a significant portion of its revenues. Changes in overseas economic conditions, currency exchange rates, foreign tax laws, or tariffs or other trade regulations could have a material adverse effect on the Company's business, financial condition and results of operations. The international nature of the Company's business subjects it and its representatives, agents and distributors to laws and regulations of the foreign jurisdictions in which it operates or in which its products are sold. The regulation of medical devices in a number of such jurisdictions, particularly in the European Community, continues to develop and there can be no assurance that new laws or regulations will not have a material adverse effect on the Company's business. The laws of certain foreign countries may not protect the Company's intellectual property rights to the same extent, as do the laws of the United States. Currently, most of the Company's international sales are denominated in U.S. dollars or the U.K. pound sterling. The Company has significant operations in the U.K., and therefore, incurs significant operating expenses denominated in U.K. pounds. Accordingly, the Company has not historically attempted to reduce the risk of currency fluctuations by hedging, as changes in exchange rates between the U.S. dollar and the U.K. pound sterling immaterially affect the Company's results of operations. However, there can be no assurance that the Company will 20 not be disadvantaged with respect to its competitors operating in a foreign country by foreign currency exchange rate fluctuations that make the Company's products more expensive relative to those of local competitors. INTERNATIONAL AVAILABILITY OF THIRD-PARTY REIMBURSEMENT; HEALTH CARE REFORM AND RELATED MATTERS In the United States, hospitals, physicians and other health care providers that purchase medical devices generally rely on Third-Party Payors, and other sources of reimbursement for health care costs to reimburse all or part of the cost of the procedure in which the medical device is being used. Certain Third- Party Payors are moving toward a managed care system in which they contract to provide comprehensive health care for a fixed cost per person. The fixed cost per person established by these Third-Party Payors may be independent of the hospital's cost incurred for the specific case and the specific devices used. Medicare and other Third-Party Payors are increasingly scrutinizing whether to cover new products and the level of reimbursement for covered products. Because the Company's fetal cell screening technology is currently under development and has not received FDA clearance or approval, uncertainty exists regarding the availability of third-party reimbursement for procedures that would use the Company's fetal cell screening technology. Failure by physicians, hospitals and other potential users of the Company's products or products currently under development to obtain sufficient reimbursement from Third-Party Payors for the procedures in which the Company's products or products currently under the development are intended to be used could have a material adverse effect on the Company's business, financial condition and results of operations. Third-Party Payors that do not use prospectively fixed payments increasingly use other cost-containment processes that may pose administrative hurdles to the use of the Company's products and products currently under development. In addition, Third-Party Payors may deny reimbursement if they determine that the device used in a treatment is unnecessary, inappropriate, experimental, used for a non-approved indication or is not cost-effective. Potential purchasers must determine that the clinical benefits of the Company's products justify the additional cost or the additional effort required to obtain prior authorization or coverage and the uncertainty of actually obtaining such authorization or coverage. If the Company obtains the necessary foreign regulatory registrations or approvals, market acceptance of the Company's products and products currently under development in international markets would be dependent, in part, upon the availability of reimbursement within prevailing health care payment systems. Reimbursement and health care payment systems in international markets vary significantly by country, and include both government-sponsored health care and private insurance. There can be no assurance that any international reimbursement approvals will be obtained in a timely manner, if at all. Failure to receive international reimbursement approvals could have a material adverse effect on market acceptance of the Company's products in the international markets in which such approvals are sought. The Company believes that in the future, reimbursement will be subject to increased restrictions both in the United States and in international markets. The Company believes that the overall escalating cost of medical products and services will continue to lead to increased pressures on the health care industry, both foreign and domestic, to reduce the cost of products and services, including the Company's products and products currently under development. There can be no assurance in either United States or international markets that third-party reimbursement and coverage will be available or adequate, that future legislation, regulation or reimbursement policies of Third-Party Payors will not otherwise adversely affect the demand for the Company's products or products currently under development or its ability to sell its products on a profitable basis. The unavailability of Third-Party Payor coverage or the inadequacy of reimbursement could have a material adverse effect on the Company's business, financial condition and results of operations. In addition, fundamental reforms in the health care industry in the United States and Europe continue to be considered, and there can be no assurance that such reform will not materially adversely affect the Company's business, financial condition and results of operations. 21 DEPENDENCE UPON KEY PERSONNEL The Company's future success depends in significant part upon the continued service of certain key scientific, technical and management personnel, and its continuing ability to attract and retain highly qualified scientific, technical and managerial personnel. Competition for such personnel is intense and there can be no assurance that the Company can retain its key scientific, technical and managerial personnel or that it can attract, assimilate or retain other highly qualified scientific, technical and managerial personnel in the future. The loss of key personnel especially if without advanced notice, or the inability to hire or retain qualified personnel could have a material adverse effect upon the Company's business, results of operations and financial condition. RISK OF SOFTWARE DEFECTS The Company's cytogenetic and prenatal screening products currently under development involve a software component that facilitates the detection of chromosomal and genetic abnormalities through the interaction of certain imaging algorithms with the genetic sample under examination. The software, including any new versions that may be released, may contain undetected errors or failures. There can be no assurance that, despite testing by the Company and current and potential customers, errors will not be found in the software components of the Company's cytogenetic or prenatal screening products, resulting in loss or delay in market acceptance, which could have a material adverse effect on the Company's business, financial condition and results of operations. PRODUCT LIABILITY RISK; POSSIBLE INSUFFICIENCY OF INSURANCE The manufacture and sale of the Company's products involves the risk of product liability claims. There can be no assurance that the coverage limits of the Company's insurance policies will be adequate. The Company intends to evaluate its coverage on a regular basis and in connection with the introduction of products currently under development. Such insurance is expensive and may not be available on acceptable terms, in sufficient amount of coverage, or at all. A successful claim brought against the Company in excess of its insurance coverage would have a material adverse effect on the Company's business, results of operations and financial condition. POSSIBLE VOLATILITY OF STOCK The market prices for securities of medical diagnostic instrument companies have historically been highly volatile. Announcements of technological innovations or new products by the Company or its competitors, developments concerning proprietary rights, including patents and litigation matters, publicity regarding actual or potential results with respect to products under development by the Company or others, regulatory developments in both the United States and foreign countries and public concern as to the safety of new technologies, changes in financial estimates by securities analysts or failure of the Company to meet such estimates and other factors, may have a significant impact on the market price of the Common Stock. In addition, the Company believes that fluctuations in its operating results may cause the market price of its Common Stock to fluctuate, perhaps substantially. 22 ANTI-TAKEOVER EFFECT OF DELAWARE LAW AND CERTAIN CHARTER AND BYLAWS PROVISIONS Certain provisions of the Company's Restated Certificate of Incorporation and Bylaws may have the effect of making it more difficult for a third party to acquire, or discouraging a third party from attempting to acquire, control of the Company. Such provisions could limit the price that certain investors might be willing to pay in the future for shares of the Company's Common Stock. Certain of these provisions provide for the elimination of the right of stockholders to act by written consent without a meeting and specify procedures for director nominations by stockholders and submission of other proposals for consideration at stockholder meetings. In addition, the Company's Board of Directors has the authority to issue up to 6,000,000 shares of Preferred Stock and to determine the price, rights, preferences, privileges and restrictions of those shares without any further vote or action by the stockholders. The rights of the holders of Common Stock will be subject to, and may be adversely affected by, the rights of the holders of any Preferred Stock that may be issued in the future. The issuance of Preferred Stock, while providing desirable flexibility in connection with possible acquisitions and other corporate purposes, could have the effect of making it more difficult for a third party to acquire a majority of the outstanding voting stock of the Company. The Company has no present plans to issue shares of Preferred Stock. Certain provisions of Delaware law applicable to the Company could also delay or make more difficult a merger, tender offer or proxy contest involving the Company, including Section 203 of the Delaware General Corporation Law, which prohibits a Delaware corporation from engaging in any business combination with any interested stockholder for a period of three years unless certain conditions are met. The inability of stockholders to act by written consent without a meeting, the procedures required for director nominations and stockholder proposals and Delaware law could have the effect of delaying, deferring or preventing a change in control of the Company, including without limitation, discouraging a proxy contest or making more difficult the acquisition of a substantial block of the Company's Common Stock. These provisions could also limit the price that investors might be willing to pay in the future for shares of the Company's Common Stock. 23 ITEM 2. PROPERTIES In the United States, Applied Imaging leases an approximately 14,000 square foot facility in Santa Clara, California, under a lease which terminates in November 30, 1998. The Company is currently reviewing its options which may include renewing its existing lease or moving to a new facility. The Company also leases an approximately 2,700 square foot facility in Pittsburgh, Pennsylvania, under a lease that terminates in July 1999. In the United Kingdom, Applied Imaging International Ltd. (''AII'') leases an approximately 10,000 square foot facility in Sunderland, which lease terminates in June 1998. AII has recently negotiated a new 10 year lease for a 12,000 foot facility in Newcastle and expects to take occupancy in June 1998. The Company believes that its facilities are adequate to meet its requirements through 1998. ITEM 3. LEGAL PROCEEDINGS The Company is not party to any legal proceedings. ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS Not applicable. 24 PART II Item 5. MARKET FOR REGISTRANT'S COMMON EQUITY AND RELATED STOCKHOLDER MATTERS The Company's Common Stock is traded on the Nasdaq National Market under the symbol "AICX." The following table sets forth the range of the high and low sale prices by quarter as reported on the Nasdaq National Market from November 1996, when the Company's Common Stock commenced trading. HIGH LOW ------ ------- 1996 Fourth Quarter 9 1/4 6 1/4 1997 First Quarter 9 1/4 5 Second Quarter 6 7/8 3 3/8 Third Quarter 6 7/8 4 1/8 Fourth Quarter 6 1/8 1 13/16 As of March 12, 1998, the number of common stockholders of record was 165. The Company currently intends to retain any earnings for use in its business and does not anticipate paying any cash dividends in the foreseeable future. On November 7, 1996, the Company commenced and completed its initial public offering (the "IPO") of 1,650,000 shares of its Common Stock, $0.001 par value per share, at a public offering price of $7.00 per share pursuant to a registration statement on Form S-1 (file no. 333-06703) filed with the Securities and Exchange Commission. All of the shares registered were sold. Montgomery Securities, Dillon, Read & Co. Inc. and Vector Securities International, Inc., were the managing underwriters of the IPO. Aggregate gross proceeds to the Company from the IPO (prior to deduction of underwriting discounts and commissions and expenses of the offering) were $11,550,000. There were no selling stockholders in the IPO. The Company paid underwriting discounts and commissions of $808,500 and other expenses of approximately $1,020,500 in connection with the IPO. The total expenses paid by the Company in the IPO were approximately $1,829,000, and the net proceeds to the Company in the IPO were approximately $9,721,000. From November 7, 1996, the effective date of the Registration Statement, to December 31, 1997, the approximate amount of net proceeds used were $7,200,000 for the development and commercialization of the Company's prenatal screening system; including costs related to clinical trials and regulatory approval, $258,000 for repayment of the Company's bank line of credit due in November 1996, and $909,000 for working capital and general corporate purposes. 25 ITEM 6. SELECTED FINANCIAL DATA
YEAR ENDED DECEMBER 31, ----------------------------------------------------------------- 1997 1996 1995 1994 1993 -------------- -------------- ----------- --------- --------- (IN THOUSANDS, EXCEPT PER SHARE DATA) Statement of Operations Data: Revenues: Product sales............................................. $ 10,457 $ 9,259 $ 8,106 $ 7,021 $ 6,189 Software maintenance and service.......................... 2,677 2,663 2,692 2,550 2,499 ---------- ---------- ---------- -------- -------- Total revenues........................................... 13,134 11,922 10,798 9,571 8,681 Cost of revenues........................................... 6,284 5,974 5,484 5,350 4,965 ---------- ---------- ---------- -------- -------- Gross profit............................................. 6,850 5,948 5,314 4,221 3,716 Operating Expenses: Research and development.................................. 7,381 3,667 2,919 2,821 1,756 Sales and marketing....................................... 3,740 3,088 2,918 2,524 2,543 General and administrative................................ 3,639 2,088 2,094 1,898 1,229 ---------- ---------- ---------- -------- -------- Total operating expenses................................. 14,760 8,843 7,931 7,243 5,528 ---------- ---------- ---------- -------- -------- Operating loss........................................... (7,910) (2,895) (2,617) (3,022) (1,812) Other income, net.......................................... 398 14 71 52 39 ---------- ---------- ---------- -------- -------- Net loss................................................... $ (7,512) $ (2,881) $ (2,546) $ (2,970) $ (1,773) ========== ========== ========== ======== ======== Net loss per share Basic and diluted $(1.03) $(1.43) $(2.46) $(3.07) $(1.88) ========== ========== ========== ======== ======== Shares used to calculate Basic and diluted net loss per share 7,324,194 2,020,369 1,033,020 967,686 941,764 ========== ========== ========== ======== ========
DECEMBER 31, -------------------------------------------------- 1997 1996 1995 1994 1993 --------- --------- -------- -------- -------- (IN THOUSANDS) Balance Sheet Data: Cash, cash equivalents and short-term investments............ $ 8,378 $ 12,318 $ 5,156 $ 2,503 $ 4,461 Working capital.............................................. 7,171 10,700 3,249 1,712 4,756 Total assets................................................. 14,714 16,473 9,373 7,441 9,666 Non-current portion of long-term debt and capital lease obligations 89 229 231 336 173 Accumulated deficit.......................................... (19,533) (12,021) (9,140) (6,594) (3,625) Total stockholders' equity(1)................................ 8,943 12,005 4,714 2,811 5,813
___________ (1) No cash dividends have been declared with respect to the Company's Common and Preferred Stock. 26 ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS The information set forth in this Item 7 below contains forward-looking statements, (designated by an *), and the Company's actual results could differ materially from those anticipated in these forward-looking statements as a result of certain factors, including those set forth below under "Factors That May Affect Future Results," and those set forth under Item One on this document, including "Additional Risk Factors". OVERVIEW Since its inception in 1986, the Company has principally been engaged in the design, development, manufacture and marketing of automated clinical analysis systems used by cytogenetic laboratories for prenatal and other genetic screening. The Company's cytogenetic instrumentation products include systems that enable laboratories to automate aspects of the detection of chromosomal abnormalities associated with conditions such as Down Syndrome. The Company sells its cytogenetic systems to government and private clinical cytogenetic laboratories, research institutions, universities and pharmaceutical companies, and has sold such systems to approximately 600 sites in over 35 countries. In 1993, the Company established a research project to develop proprietary prenatal screening products to detect chromosomal genetic disorders through the enrichment and analysis of fetal blood cells from a routine maternal blood sample. Since that time, the Company has devoted substantial resources to the development of these prenatal screening products. The Company's prenatal screening products, which the Company is developing, incorporate (i) a patented hematologically-based procedure to enrich and separate the fetal blood cells, (ii) a fetal hemoglobin test kit, (iii) automated image analysis instrumentation to identify the fetal cells and (iv) the use of third-party DNA probes to identify certain chromosomal disorders present in fetal cells. The prenatal screening products under development are currently in preclinical evaluations, and the Company intends to continue preclinical and clinical evaluations of the products to establish them as a broadly applicable prenatal screening procedure. The Company anticipates that sales of the products, if cleared or approved by the FDA, will include a consumable enrichment kit used to separate fetal blood cells from maternal blood, a consumable hemoglobin identification kit and imaging instrumentation used to analyze these cells. The implementation of the Company's strategy is dependent upon the successful development and commercialization of the Company's prenatal screening products. The operating results of the Company have fluctuated significantly in the past on an annual and quarterly basis. The Company expects that its operating results will fluctuate significantly from quarter to quarter and year to year in the future and will depend on a number of factors, some of which may affect future sales of the Company's cytogenetic products. These factors include, but are not limited to, demand for the Company's products, timing of orders and shipments, competition and its related pricing pressures, and seasonal factors, many of which are outside the Company's control. If FDA clearance or approval is received, the Company intends to increase the amount of expenditures for research and development and sales and marketing activities, principally for the commercial launch of its prenatal screening system. If additional funding is obtained, the Company intends to increase its research and development expenses related to follow-on products and additional applications of its prenatal screening technology. The Company also intends to increase the amount of expenditures related to marketing and administrative activities. The Company markets its products worldwide from its operations in the United States and the United Kingdom and performs research and development in the United States and Israel. Sales from the United States are primarily to customers within the United States. Revenues in the United Kingdom result from drop shipments of products from the United States directly to customers and from direct shipments from the United Kingdom. RESULTS OF OPERATIONS Revenues. Revenues increased to $13.1 million in 1997 from $11.9 million in -------- 1996, and from $10.8 million in 1995, or annual increases of 10% for 1997 and 1996. The 1997 and 1996 increases in revenues were primarily attributable to continued demand by cytogenetic laboratories to automate aspects of otherwise labor-intensive analyses, to increase capacity of existing systems, or to replace older generation systems with the Company's 27 CytoVision products. Software and service contract revenues have remained relatively flat at $2.7 million for 1997, 1996 and 1995, and as a percentage of total revenues, decreased to 20% in 1997 from 22% in 1996 and from 25% in 1995. Software and service contract pricing is derived from product pricing, and with unit selling prices of the Company's CytoVision products, sold since 1994, significantly lower than earlier generation products, software and service contract pricing has decreased accordingly. For 1997, 1996 and 1995, revenues derived outside of North America have remained relatively consistent at approximately 59%, 60% and 61% of total revenues, respectively. Cost of Revenues. Cost of revenues increased to $6.3 million in 1997, from ---------------- $6.0 million in 1996 and from $5.5 million in 1995, or 48%, 50% and 51% as a percentage of total revenues, respectively. This decrease in cost of revenues as a percentage of total revenues from year to year was attributable to increased product shipment volume and engineering design changes to reduce direct material and production costs. The decrease in cost of software maintenance and service is primarily due to lower staffing and material costs as a result of improved components which reduced the number of service calls. Research and Development Expenses. Research and development expenses --------------------------------- increased to approximately $7.4 million in 1997 from $3.7 million in 1996 and from $2.9 million in 1995. These year to year increases were due to increasing expenditures on the development of the prenatal screening products. Sales and Marketing Expenses. Sales and marketing expenses increased to $3.7 ---------------------------- million in 1997 from $3.1 million in 1996 and from $2.9 million in 1995. In 1997, 1996 and 1995, sales and marketing expenses as a percentage of total revenues remained relatively consistent ranging from 26% to 28%. The increase in 1997 is primarily attributable to additional marketing and sales management personnel and the associated recruitment and relocation costs. General and Administrative Expenses. General and administrative expenses in ----------------------------------- 1997 amounted to $3.6 million, increasing $1.5 million over 1996 and 1995. The increase is primarily due to increased administrative and management staff and associated costs related to public company reporting requirements and management infrastructure changes in anticipation of future growth. In addition, the Company incurred a charge of $480,000 in 1997 associated with executive management changes. In 1997, 1996 and 1995 general and administrative expenses were 28%, 18% and 19% of total revenues, respectively. FACTORS THAT MAY AFFECT FUTURE RESULTS The Company's operating results may vary significantly depending on certain factors, including the effect of delays in its research and development program, adverse results in its clinical studies, delay in the introduction or shipment of new products, increased competition, adverse changes in the economic conditions in any of the several countries in which the Company does business, a slower growth rate in the Company's target markets, order deferrals in anticipation of new product releases, lack of market acceptance of new products, the uncertainty of FDA or other domestic and international regulatory clearances or approvals. For example, the Company expects a decline in 1998 first quarter revenues primarily as a result of the currency issues involving Southeast Asia and certain other Asian countries. * Due to the factors noted above, as well as the size of the Company's initial public offering completed in November, 1996, the Company's future earnings and stock price may be subject to significant volatility, particularly on a quarterly basis. Any shortfall in revenues or earnings from levels expected by security analysts could have an immediate and significant adverse effect on the trading price of the Company's common stock. LIQUIDITY AND CAPITAL RESOURCES Since its inception in July 1986 through December 1997, the Company has generated an accumulated deficit of approximately $19.5 million. As of December 31, 1997, the Company had cash, cash equivalents and short-term investments of $8.4 million and working capital of $7.2 million, compared to $12.3 million and $10.7 million, respectively, at December 31, 1996. For the year ended December 31, 1997, cash used by operations totaled $7.2 28 million, compared to $1.8 million for the corresponding prior year. The increase in cash used by operations was primarily attributable to increased operating expenses associated with the Company's fetal cell screening program, increased general and administrative expenses to support future growth, public company reporting and compliance requirements, and a $1.9 million increase in accounts receivable. In addition, the Company consumed $1.1 million in 1997 for purchases of capital equipment compared to $0.5 million for the comparable prior year. Cash consumption from operations and property and equipment purchases was partially offset by cash generated from financing activities which were primarily the result of a private equity placement in May 1997 that netted $3.9 million. The Company expects negative cash flow from operations to continue into at least 1999, as it continues the development of its fetal cell technology, conducts clinical trials required for FDA clearance of the DNA probe portion of that technology, expands its marketing, sales and customer support capabilities, and adds administrative infrastructure. * The Company currently estimates that its capital resources will enable it to sustain through 1998*. There can be no assurance, however, that the Company will not be required to seek capital at an earlier date. The timing and amount of spending of such capital resources cannot be accurately determined at this time and will depend on several factors, including but not limited to, the progress of its research and development efforts and clinical investigation, the timing of regulatory approvals or clearances, competing technological and market developments, commercialization of products currently under development, and market acceptance and demand for the Company's products. In addition, as opportunities arise, proceeds may also be used to acquire businesses, technologies or products that complement any such acquisitions. * The Company may seek to obtain additional funds through equity or debt financing, collaborative or other arrangements with other companies, and from other sources. * No assurance can be given that additional financing will be available when needed or on terms acceptable to the Company. If adequate funds are not available, the Company could be required to delay development or commercialization of certain products, to license to third parties the rights to commercialize certain products or technologies that the Company would otherwise seek to commercialize itself, or to reduce the marketing, customer support, or other resources devoted to certain products. * Year 2000 Compliance The Company is aware of the issues associated with the programming code in existing computer systems as the year 2000 approaches. The "year 2000 problem" is pervasive and complex as virtually every computer operation will be affected in some way by the rollover of the two-digit year value to 00. The issue is whether computer systems will properly recognize date sensitive information when the year changes to 2000. Systems that do not properly recognize such information could generate erroneous data or cause a system to fail. Management is in the process of working with its software vendors to assure that the Company is prepared for the year 2000*. Management does not anticipate that the Company will incur significant operating expenses or be required to invest heavily in computer systems improvements to be year 2000 compliant*. However, significant uncertainty exists concerning the potential costs and effects associated with any year 2000 compliance. The Company will implement an upgrade to its management information system that the Company believes is year 2000 compliant*. Any year 2000 compliance problem of either the company or its suppliers or partners or customers, could materially adversely affect the Company's business, results of operation, financial condition and prospects*. New Accounting Pronouncements On February 3, 1998, the Securities and Exchange Commission (''SEC'') issued Staff Accounting Bulletin (''SAB'') No. 98. SAB No. 98 requires certain stock options and warrants issued for nominal consideration to be treated as outstanding for all reporting periods in the same manner as shares issued in a stock split or a recapitalization effected contemporaneously with the initial public offering. The Company originally included shares issued to employees at less than fair market value as nominal issuances in the earnings per share (''EPS'') calculation, as presented in the Company's press release on February 10, 1998. Subsequently, the SEC indicated that nominal shares generally do not include options issued to employees for services rendered. The Company recomputed EPS in accordance with the most recent guidance provided by the SEC with respect to SAB No. 98. 29 In October 1997, the American Institute of Certified Public Accounts issued Statement of Position (''SOP'') No. 97-2, "Software Revenue Recognition," which supersedes SOP No. 91-1. The Company will be required to adopt SOP 97-2 prospectively for software transactions entered into beginning January 1, 1998. SOP No. 97-2 generally requires revenue earned on software arrangements involving multiple elements such as software products, upgrades, enhancements, post-contract customer support, installation, and training to be allocated to each element based on the relative fair values of the elements. The fair value of an element must be based on evidence that is specific to the vendor. If a vendor does not have evidence of the fair value for all elements in a multiple- element arrangement, all revenue from the arrangement is deferred until such evidence exists or until all elements are delivered. The Company's management anticipates that the adoption of SOP No. 97-2 will not have a material effect on the Company's operating results. In June 1997, the FASB issued SFAS 130, "Reporting Comprehensive Income". This Statement establishes standards for reporting and displaying comprehensive income and its components in the financial statements. It requires that a company classify items of other comprehensive income, as defined by accounting standards, by their nature (e.g. unrealized gains or losses on securities) in a financial statement, but does not require a specific format for that statement. The Company is in the process of determining its preferred format. The accumulated balance of other comprehensive income is to be displayed separately from retained earnings and additional paid-in capital in the equity section of the balance sheet. This Statement is effective with fiscal 1998 financial statements. Reclassification of financial statements for earlier periods provided for comparative purposes is required. In June 1997, the FASB issued SFAS 131, "Disclosures about Segments of an Enterprise and Related Information". The Statement requires that a public business enterprise report financial and descriptive information about its reportable operating segments on the basis that is used internally for evaluating segment performance and deciding how to allocate resources to segments. This statement is effective with fiscal 1998 financial statements. The Company is currently evaluating the implications of this statement. 30 ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA REPORT OF INDEPENDENT CERTIFIED PUBLIC ACCOUNTANTS The Board of Directors Applied Imaging Corp.: We have audited the accompanying consolidated balance sheets of Applied Imaging Corp. and subsidiaries as of December 31, 1997 and 1996, and the related consolidated statements of operations, stockholders' equity, and cash flows for each of the years in the three-year period ended December 31, 1997. These consolidated financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on these consolidated financial statements to 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 financial position of Applied Imaging Corp. and subsidiaries as of December 31, 1997 and 1996, and the results of their operations and their cash flows for each of the years in the three-year period ended December 31, 1997, in conformity with generally accepted accounting principles. KPMG Peat Marwick LLP Mountain View, California February 6, 1998 31 APPLIED IMAGING CORP. AND SUBSIDIARIES Consolidated Balance Sheets
1997 1996 ----------- ----------- Assets Current assets: Cash and cash equivalents.......................................... $ 2,918,000 $12,318,000 Short-term investments............................................. 5,460,000 -- Trade accounts receivable (less allowance for doubtful accounts of $ 191,000 and $228,000).............................. 3,358,000 1,454,000 Inventories........................................................ 849,000 831,000 Prepaid expenses and other assets.................................. 268,000 336,000 ----------- ----------- Total current assets................................................. 12,853,000 14,939,000 Property and equipment............................................... 1,793,000 1,234,000 Other assets......................................................... 68,000 300,000 ----------- ----------- $14,714,000 $16,473,000 =========== =========== Liabilities and Stockholders' Equity Current liabilities: Current portion of bank debt....................................... $ 299,000 $ 33,000 Current portion of capital lease obligation........................ 34,000 -- Accounts payable................................................... 1,754,000 1,679,000 Accrued expenses................................................... 2,434,000 1,304,000 Deferred revenue................................................... 1,161,000 1,223,000 --------- --------- Total current liabilities........................................ 5,682,000 4,239,000 Bank debt, less current portion...................................... -- 229,000 Capital lease obligation, less current portion....................... 89,000 -- Commitments Stockholders' equity: Common stock; $0.001 par value; 20,000,000 shares authorized; 7,667,956 and 6,823,835 shares issued and outstanding............ 8,000 7,000 Additional paid-in capital......................................... 29,636,000 25,569,000 Accumulated deficit................................................ (19,533,000) (12,021,000) Deferred stock compensation........................................ (801,000) (1,183,000) Cumulative translation adjustment.................................. (367,000) (367,000) ------------ ------------ Total stockholders' equity....................................... 8,943,000 12,005,000 $ 14,714,000 $ 16,473,000 ============ ============
See accompanying notes to consolidated financial statements. 32 APPLIED IMAGING CORP. AND SUBSIDIARIES Consolidated Statements of Operations
December 31, ------------------------------------------------------ 1997 1996 1995 ---------------- ----------------- ----------------- Revenues: Product sales.................................................. $10,457,000 $ 9,259,000 $ 8,106,000 Software maintenance and service............................... 2,677,000 2,663,000 2,692,000 ----------- ----------- ----------- Total revenues................................................ 13,134,000 11,922,000 10,798,000 ----------- ----------- ----------- Cost of revenues: Product sales.................................................. 5,188,000 4,501,000 4,171,000 Software maintenance and service............................... 1,096,000 1,473,000 1,313,000 ----------- ----------- ----------- Total cost of revenues........................................ 6,284,000 5,974,000 5,484,000 ----------- ----------- ----------- Gross profit.................................................. 6,850,000 5,948,000 5,314,000 ----------- ----------- ----------- Operating expenses: Research and development....................................... 7,381,000 3,667,000 2,919,000 Sales and marketing............................................ 3,740,000 3,088,000 2,918,000 General and administrative..................................... 3,639,000 2,088,000 2,094,000 ----------- ----------- ----------- Total operating expenses...................................... 14,760,000 8,843,000 7,931,000 ----------- ----------- ----------- Operating loss................................................ (7,910,000) (2,895,000) (2,617,000) Other income, net................................................ 398,000 14,000 71,000 ----------- ----------- ----------- Net loss...................................................... $(7,512,000) $(2,881,000) $(2,546,000) =========== =========== =========== Net loss per share-Basic and diluted............................. $(1.03) $(1.43) $(2.46) =========== =========== =========== Shares used to calculate Basic and diluted net loss per share.... 7,324,194 2,020,369 1,033,020 =========== =========== ===========
See accompanying notes to consolidated financial statements. 33 APPLIED IMAGING CORP. AND SUBSIDIARIES Consolidated Statements of Stockholders' Equity
PREFERRED STOCK COMMON STOCK ADDITIONAL DEFERRED ------------------------ ---------------- PAID-IN ACCUMULATED STOCK SHARES AMOUNT SHARES AMOUNT CAPITAL DEFICIT COMPENSATION ----------- ----------- ------- ------- ---------- ----------- ------------ Balances as of December 31, 1994....................... 2,812,962 $ 3,000 973,510 $ 1,000 $ 9,768,000 $ (6,594,000) -- Exercise of common stock options................... -- -- 94,275 -- 44,000 -- -- Compensation expense related to employee stock options............. -- -- -- -- 59,000 -- -- Issuances of Series J preferred stock, net of $356,000 offering costs... 1,106,217 1,000 -- -- 4,345,000 -- -- Net loss................... -- -- -- -- -- (2,546,000) -- ---------- ---------- --------- ------- ----------- ------------ ------------ Balances as of December 31, 1995....................... 3,919,179 4,000 1,067,785 1,000 14,216,000 (9,140,000) -- Exercise of common stock options................... -- -- 89,250 -- 161,000 -- -- Initial public offering (IPO) of common stock, net of $1,829,000 offering costs............ -- -- 1,650,000 2,000 9,719,000 -- -- Preferred stock converted to common stock in connection with IPO....... (3,919,179) (4,000) 3,960,017 4,000 -- -- -- Net exercise of 110,416 Series F preferred stock warrants in connection with IPO.................. -- -- 56,783 -- -- -- -- Deferred employee stock option compensation....... -- -- -- -- 1,473,000 -- (1,473,000) Amortization of deferred stock compensation........ -- -- -- -- -- -- 290,000 Net loss................... -- -- -- -- -- (2,881,000) -- ---------- ---------- --------- ------- ----------- ------------ ------------ Balances as of December 31, 1996...................... -- -- 6,823,835 7,000 25,569,000 (12,021,000) (1,183,000) Exercise of common stock... options................... -- -- 34,003 -- 72,000 -- -- Private placement of common stock net of $59,000 offering costs.................... -- -- 796,020 1,000 3,940,000 -- -- Stock issued in connection with employee stock purchase plan..................... -- -- -- 14,098 -- 55,000 -- Amortization of deferred stock compensation........ -- -- -- -- -- -- 382,000 Net Loss................... -- -- -- -- -- (7,512,000) -- Balances as of December 31, 1997....................... -- -- 7,667,956 $ 8,000 $29,636,000 $(19,533,000) $ (801,000) ========== ========== ========= ======= =========== ============ ============
CUMULATIVE TOTAL TRANSLATION STOCKHOLDERS' ADJUSTMENT EQUITY ------------ -------------- Balances as of December 31, 1994....................... $(367,000) $ 2,811,000 Exercise of common stock options................... -- 44,000 Compensation expense related to employee stock options............. -- 59,000 Issuances of Series J preferred stock, net of $356,000 offering costs... -- 4,346,000 Net loss................... -- (2,546,000) ----------- ----------- Balances as of December 31, 1995....................... (367,000) 4,714,000 Exercise of common stock options................... -- 161,000 Initial public offering (IPO) of common stock, net of $1,829,000 offering costs............ -- 9,721,000 Preferred stock converted to common stock in connection with IPO....... -- -- Net exercise of 110,416 Series F preferred stock warrants in connection with IPO.................. -- -- Deferred employee stock option compensation....... -- -- Amortization of deferred stock compensation........ -- 290,000 Net loss................... -- (2,881,000) ----------- ----------- Balances as of December 31, 1996...................... (367,000) 12,005,000 Exercise of common stock... options................... -- 72,000 Private placement of common stock net of $59,000 offering costs.... -- 3,941,000 Stock issued in connection with employee stock purchase plan..................... -- 55,000 Amortization of deferred stock compensation........ -- 382,000 Net Loss................... -- (7,512,000) Balances as of December 31, 1997....................... $(367,000) $ 8,943,000 =========== ===========
See accompanying notes to consolidated financial statements. 34 APPLIED IMAGING CORP. AND SUBSIDIARIES Consolidated Statements of Cash Flows
December 31, ----------------------------------------------------- 1997 1996 1995 ---------------- ----------------- ----------------- Cash flows from operating activities: Net loss....................................................... $(7,512,000) $(2,881,000) $(2,546,000) Adjustments to reconcile net loss to net cash used for operating activities: Depreciation and amortization................................. 695,000 583,000 556,000 Unrealized exchange (gain) loss............................... -- 33,000 (17,000) Compensation expense related to employee stock options........ 382,000 290,000 153,000 Loss on sale of other assets.................................. 29,000 -- -- Changes in operating assets and liabilities: Trade accounts receivable................................... (1,904,000) 47,000 439,000 Inventories................................................. (18,000) 49,000 253,000 Prepaid expenses and other assets........................... 68,000 (196,000) 290,000 Accounts payable............................................ 75,000 538,000 (309,000) Accrued expenses............................................ 1,130,000 (126,000) 497,000 Deferred revenue............................................ (62,000) (163,000) 91,000 ----------- ----------- ----------- Net cash used for operating activities...................... (7,117,000) (1,826,000) (593,000) Cash flows from investing activities: Purchase of short-term investments............................. (7,456,000) -- (2,997,000) Proceeds from sales and maturities of investments.............. 1,996,000 2,997,000 -- Purchase of equipment.......................................... (1,119,000) (498,000) (808,000) Other assets................................................... 203,000 71,000 9,000 ----------- ----------- ----------- Net cash provided by (used for) investing activities........ (6,376,000) 2,570,000 (3,796,000) ----------- ----------- ----------- Cash flows from financing activities: Proceeds from issuance of preferred stock...................... -- -- 4,346,000 Net proceeds from issuance of common stock..................... 4,068,000 9,882,000 44,000 Bank loan proceeds/(payments) - net............................ 38,000 (467,000) (345,000) Capital lease payments......................................... (13,000) -- -- ----------- ----------- ----------- Net cash provided by financing activities................... 4,093,000 9,415,000 4,045,000 ----------- ----------- ----------- Net increase (decrease) in cash and cash equivalents............. (9,400,000) 10,159,000 (344,000) Cash and cash equivalents at beginning of year................... 12,318,000 2,159,000 2,503,000 ----------- ----------- ----------- Cash and cash equivalents at end of year......................... $ 2,918,000 $12,318,000 $ 2,159,000 =========== =========== =========== Supplemental disclosure of cash paid for interest................ $ 39,000 $ 86,000 $ 110,000 =========== =========== =========== Supplemental disclosure of non-cash investing and financing activities: Equipment acquired through capital leases................. $ 135,000 -- -- =========== =========== =========== Deferred compensation relating to employee stock options.. -- $ 1,473,000 -- =========== =========== =========== Conversion of preferred stock and preferred stock warrants into common stock........................................... -- $ 4,000 -- =========== =========== ===========
See accompanying notes to consolidated financial statements. 35 APPLIED IMAGING CORP. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (1) Summary of the Company and Significant Accounting Policies The Company Applied Imaging Corp. (the Company) was incorporated in 1986 to develop, manufacture, and market automated clinical analysis systems used by cytogenetic laboratories in prenatal genetic screening. The Company sells its products to government and private clinical cytogenetic laboratories, research institutions, universities, and pharmaceutical companies located primarily in the United States, Canada, Europe, and the Pacific Rim. The Company is currently devoting significant resources to the development of a new prenatal screening designed to enable the detection of prenatal chromosomal disorders through the analysis of fetal blood cells drawn from maternal blood. There have been no revenues earned in relation to this new prenatal screening system. Principles of Consolidation The accompanying consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries, Applied Imaging International, Limited (United Kingdom) and Applied Imaging, Limited (Israel). All significant intercompany accounts and transactions have been eliminated in consolidation. Foreign Exchange The Company accounts for its foreign operations in accordance with Statement of Financial Accounting Standards (SFAS) No. 52, Foreign Currency Translation. Prior to April 1994, the functional currency for Applied Imaging International, Limited was the British pound and, accordingly, translation adjustments resulting from the conversion of the subsidiary's financial statements into U.S. dollars were accumulated and reported as a separate component of stockholders' equity. Beginning in April 1994, certain operational and organizational changes within the Company caused the functional currency for the Company's subsidiary to become the U.S. dollar. Therefore, monetary assets and liabilities of the subsidiary are remeasured at year-end exchange rates while nonmonetary items are remeasured at historical rates. Revenue and expense accounts related to monetary assets and liabilities are remeasured at the average rates in effect during the year. Revenue and expenses related to non-monetary assets and liabilities are translated at historical rates. Translation adjustments resulting from the conversion of the subsidiary's financial statements into U.S. dollars are currently recognized in the consolidated statement of operations in the year of occurrence. The functional currency of Applied Imaging, Limited is also the U.S. dollar. Use of Estimates The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the 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. Initial Public Offering The Company completed its initial public offering on November 7, 1996, whereby 1,650,000 shares of common stock were issued for approximately $9,721,000 in proceeds, net of underwriters' discounts and issuance costs of $1,829,000. Amounts included in the accompanying balance sheet as of December 31, 1997 and 1996, reflect the conversion of all outstanding shares of preferred stock into 3,960,017 shares of common stock and the net exercise of the Series F warrants into 56,783 shares of common stock. 36 APPLIED IMAGING CORP. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS--(Continued) Revenue Recognition The Company recognizes revenue on product sales upon shipment and concurrently accrues for expected hardware warranty expenses, and product returns. Revenue on renewed maintenance contracts, including amounts attributable to software maintenance bundled in original product sale agreements, is deferred and recognized ratably over the period of the contract, generally one year. Research and Development Expenditures Research and development expenditures are charged to expense as incurred. Earnings (loss) per Share The company has reported losses per share in accordance with the Financial Accounting Standards Board (FASB) Statement of Financial Accounting Standards No. 128 ''Earnings Per Share.'' SFAS No. 128 which requires the presentation of basic earnings per share (''EPS'') and, for companies with complex capital structures (or potentially dilutive securities, such as convertible debt, options and warrants), diluted EPS. There were no reconciling items of the numerators and denominators of the basic and diluted EPS computation. Securities excluded from the computation of EPS because their effect on EPS was antidilutive, but could dilute basic EPS in future periods are as follows:
1997 1996 1995 ------------------ ------------------ ------------------ Options 1,199,272 481,250 356,250 Warrants 681,744 508,734 565,517 Preferred Stock -- -- 3,960,017 --------- ------- --------- Total 1,881,016 989,984 4,881,784 ========= ======= =========
Cash Equivalents and Short-Term Investments All investments with original maturities of three months or less are considered by the Company to be cash equivalents. Inventories Inventories are stated at the lower of cost (first in, first out) or market. Property and Equipment Property and equipment are stated at cost less accumulated depreciation. Depreciation is provided using the straight-line method over the estimated useful lives of the respective assets, generally three to five years. Recoverability of property and equipment is measured by comparison of its carrying amount to future net cash flows the property and equipment are expected to generate. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the property and equipment exceeds its fair market value. To date, the company has made no adjustments to the carrying values of its long-lived assets. 37 APPLIED IMAGING CORP. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS--(Continued) Short-Term Investments Short-term investments consist of investments acquired with maturities exceeding three months. While the Company's intent is to hold debt securities to maturity, consistent with Statement of Financial Accounting Standards (SFAS) No. 115, "Accounting for Certain Investments in Debt and Equity Securities," the Company has classified all securities as available-for-sale, as the sale of such securities may be required prior to maturity to implement management strategies. Such securities are reported at fair value with unrealized gains or losses excluded from earnings and reported as a separate component of shareholder's equity, net of applicable taxes. The cost and estimated fair value of available-for-sale securities as of December 31, 1997, by contractual maturity consisted of the following:
DUE IN ONE YEAR OR LESS DUE IN MORE THAN ONE YEAR ----------------------- ------------------------- Certificate of deposits $1,000 $2,269 Bonds $2,191 $ -- ------ --------- $3,191 $2,269 ====== ======
Capitalized Software Costs Computer software development costs incurred subsequent to the determination of product technological feasibility are capitalized in accordance with the provisions of SFAS No. 86, Accounting for the Cost of Computer Software to be Sold, Leased or Otherwise Marketed. Amortization of these capitalized costs is provided using the greater of the ratio of revenues generated in the period over total future revenues of the product, or the straight-line method over the estimated market life of the related products, generally three years, commencing when the product becomes generally available to customers. For the years ended December 31, 1997, 1996 and 1995, software development costs incurred subsequent to the establishment of technological feasibility have not been material. The net book value of capitalized costs is not significant and is included in other assets in the consolidated balance sheets. Stock Based Compensation The Company uses the intrinsic value method to account for stock-based compensation. Income Taxes The Company accounts for income taxes in accordance with SFAS No. 109, Accounting for Income Taxes, which prescribes an asset and liability approach that results in the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the Company's consolidated financial statements or tax returns. Valuation allowances are provided when necessary to reduce deferred tax assets to the amount expected to be realized. In estimating future tax consequences, SFAS No. 109 generally considers all expected future events other than enactment of changes in tax laws or rates. 38 APPLIED IMAGING CORP. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS--(Continued) Fair Value of Financial Instruments Financial instruments consist principally of cash equivalents, short-term investments, trade receivables, notes receivable, accounts payable, and bank debt. The carrying amounts of these financial instruments approximate fair value. Financial instruments that potentially subject the Company to concentrations of credit risk are cash equivalents and short-term investments which the Company places with high-credit qualified financial institutions and, by policy, limits the amount of credit exposure to any one financial institution. The Company sells its products to government and private clinical cytogenetic laboratories, research institutions, universities, and pharmaceutical companies located primarily in the United States, Canada, Europe, and the Pacific Rim. The Company's credit risk is concentrated primarily in the United States and Europe. The Company does not have a significant concentration of credit risk with any single customer. The Company performs on-going credit evaluations of its customer's financial condition and, generally requires no collateral from its customers. The Company maintains an allowance for doubtful accounts to cover potential credit losses. (2) INVENTORIES A summary of inventories follows: December 31, ----------------------- 1997 1996 -------- -------- Raw materials.......................... $721,000 $759,000 Work in process........................ 85,000 46,000 Finished goods......................... 43,000 26,000 -------- -------- $849,000 $831,000 ======== ======== (3) PROPERTY AND EQUIPMENT A summary of property and equipment follows: December 31, ----------------------- 1997 1996 -------- -------- Equipment................................. $2,793,000 $2,187,000 Demonstration equipment................... 1,275,000 875,000 Furniture and fixtures.................... 489,000 242,000 ---------- ---------- 4,557,000 3,304,000 Less accumulated depreciation............. 2,764,000 2,070,000 ---------- ---------- $1,793,000 $1,234,000 ========== ========== (4) ACCRUED EXPENSES A summary of accrued expenses follows: December 31, ----------------------- 1997 1996 -------- -------- Compensation and related costs............. $ 649,000 $ 625,000 Severance.................................. 480,000 -- Other...................................... 1,305,000 679,000 ---------- ---------- $2,434,000 $1,304,000 ========== ========== 39 APPLIED IMAGING CORP. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS--(Continued) (5) BANK DEBT A summary of bank debt follows:
DECEMBER 31, ---------------------- 1997 1996 --------- -------- Applied Imaging International, Limited: Bank note payable in monthly installments through June 2004; bearing interest at the bank's base rate plus 3% (9.00% as of December 31, 1996)............. $ -- $262,000 --------- -------- -- 262,000 Less current portion........................................ -- 33,000 --------- -------- $ -- $229,000 ========= ========
The bank note relating to Applied Imaging International, Limited is denominated in British pounds and relates to the purchase of real property from a related party in March 1994. The real property is recorded at cost, which approximates market value, and is included in other assets in the accompanying 1996 consolidated balance sheet. Such real property was sold in 1997. Applied Imaging International, Limited has a (Pounds)500,000 unsecured line of credit with an international bank which is guaranteed by the Company. The line of credit is available until April 15, 1998, and bears interest at 3% above the bank's base rate, which was 7.25% as of December 31, 1997. As of December 31, 1997 amounts outstanding under this facility amounted to $299,000. (6) STOCKHOLDERS' EQUITY Common Stock The Company is authorized to issue 20,000,000 shares of common stock. As of December 31, 1997, there were warrants outstanding to purchase 173,010 shares of common stock at $5.78 per share, 368,734 shares at $5.25 per share and 140,000 shares at $4.25 per share. These warrants expire in 2000, 1998 and 2000, respectively. As of December 31, 1997, 1,378,985 shares of common stock were reserved for issuance under the Company's 1988 Amended and Restated Incentive Stock Option Plan (the 1988 Option Plan). Under the 1988 Option Plan, stock options may be granted to Board members, officers, key employees, and consultants at the fair market value of the common stock at the date of the grant, as determined by the Board. Options are exercisable over 5 to 10 years from the date of grant, and typically vest ratably over 4 years. In 1994, the Company enacted a Directors Option Plan designed to encourage participation on the Company's Board. Under this plan, 5,000 shares per year are automatically granted to non-employee directors. The terms of the plan allow the granting of stock options upon initial election to the Board and for each subsequent term on the Board. As of December 31, 1997 there were 120,000 shares reserved for issuance under this plan and a total of 30,000 options have been granted. 40 APPLIED IMAGING CORP. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS--(Continued) Accounting for Stock-Based Compensation As of December 31, 1997, there were 209,713 options available for grant under the 1988 Option Plan. In 1996, the Company recorded a deferred charge of $1,473,000, representing the difference between the exercise price and the deemed fair value of the Company's common stock for 246,750 shares subject to common stock options granted in the 12-month period preceding the IPO. The deferred stock compensation is being amortized to compensation expense over the period during which the options become exercisable, generally four years. The Company has adopted the pro forma disclosure provisions of SFAS No. 123. Had compensation cost for the Company's stock-based compensation plans been determined in a manner consistent with the fair value approach described in SFAS No. 123 ''Accounting for Stock-Based Compensation'', the Company's net loss and pro forma net loss per share as reported would have been increased to the pro forma amounts indicated below.
YEAR ENDED DECEMBER 31, ------------------------------ 1997 1996 1995 --------- -------- --------- Net loss: As reported.......... $(7,512) $(2,881) $(2,546) Pro forma............ $(8,218) $(2,965) $(2,558) Net loss per share: As reported: Basic and diluted.. $ (1.03) $ (1.43) $ (2.46) Pro forma: Basic and diluted.. $ (1.12) $ (1.47) $ (2.48)
Pro forma net loss reflects only options granted in 1997, 1996 and 1995. Therefore, the full impact of calculating compensation cost for stock options under SFAS No. 123 is not in the pro forma net loss amounts presented above because compensation cost is reflected over the period equivalent to the options' vesting period of 4 years and compensation cost for options granted prior to January 1, 1995 is not considered. On February 2, 1998, the Company's board of directors approved an amendment to reprice options outstanding under the Company's 1988 Stock Option Plan with exercise prices over $3.00 per share. On February 2, 1998, holders of such options were offered the choice of retaining their existing options without amendment or accepting the amendment of their stock options. The exercise price of the amended options is $2.44 per share, which equals the fair market value of the Company's common stock on February 2, 1998. Vesting of the amended options occurs over four years and begins on February 2, 1998. Holders of the options had until March 30, 1998 to make an irrevocable decision to either retain their existing options without amendment or accept the amendment to their options. The amendment of the options is treated for accounting purposes as if the Company cancelled the existing options and issued on February 2, 1998 new options with the lower exercise price and new vesting schedule. The fair value of each option is estimated on the date of grant using the fair value method with the following weighted-average assumptions: volatility of 60%, no dividends, an expected life of three years, and risk-free interest rates of 6.16% for the year ended December 31, 1997, 5.71% for the year ended December 31, 1996, and 6.63% for the year ended December 31, 1995. 41 APPLIED IMAGING CORP. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS--(Continued) A summary of the status of the Company's fixed stock option activity for the years ended December 31, 1997, 1996 and 1995, is as follows:
WEIGHTED- WEIGHTED AVERAGE AVERAGE EXERCISE FAIR SHARES PRICE VALUE ---------- --------- -------- Outstanding at December 31, 1994.................... 396,550 $1.86 Granted--Exercise price equals market value......... 58,500 1.98 $0.95 Granted--Exercise price less than market value...... 8,000 1.98 7.53 Canceled............................................ (12,525) 2.27 Exercised........................................... (94,275) 0.47 --------- Outstanding at December 31, 1995.................... 356,250 2.24 Granted--Exercise price equals market value......... 238,750 2.66 7.38 Granted--Exercise prices less than market value..... 53,750 2.66 2.90 Canceled............................................ (78,250) 2.80 Exercised........................................... (89,250) 1.80 --------- Outstanding at December 31, 1996.................... 481,250 2.48 Granted--Exercise price equals market value......... 443,750 5.67 2.93 Granted--Exercise prices greater than market value.. 269,400 3.87 1.88 Granted--Exercise prices less than market value..... 60,250 4.05 $2.15 Canceled............................................ (21,375) 3.90 Exercised........................................... (34,003) 2.15 --------- Outstanding at December 31, 1997.................... 1,199,272 $4.04
The following table summarizes information about fixed stock options outstanding as of December 31, 1997:
OPTIONS OUTSTANDING OPTIONS EXERCISABLE ------------------------------------------ ------------------- WEIGHTED AVERAGE WEIGHTED WEIGHTED RANGE OF REMAINING AVERAGE AVERAGE EXERCISE NUMBER CONTRACTUAL EXERCISE EXERCISE PRICES OUTSTANDING LIFE PRICE NUMBER PRICE - --------------------- ----------- ------------------- -------- -------- --------- From $1.80 to $2.75 487,022 8.32 years $2.11 143,688 $1.80 From $2.80 to $5.63 580,750 9.07 years 5.15 49,125 2.95 From $6.13 to $7.00 131,500 9.28 years 6.26 3,501 7.00 --------- ------------------- ----- ------- ----- 1,199,272 8.79 years $4.04 196,314 $2.18
On June 19, 1996, the Board adopted, effective upon the closing of the IPO, the Company's Employee Stock Purchase Plan (the Plan) whereby eligible employees may purchase common stock through payroll deductions of up to 10% of compensation, at a per share price of 85% of the fair market value of the Company's common stock on the enrollment date or the exercise date six months later, whichever is lower. As of December 31, 1997 there were 185,902 shares reserved for issuance under the Plan. (7) INCOME TAXES The Company has not recorded an income tax benefit in 1997, 1996, and 1995 due to the recording of a valuation allowance as an offset to net deferred tax assets. A valuation allowance is provided due to uncertainties relating to the realization of deferred tax assets. 42 APPLIED IMAGING CORP. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS--(Continued) The tax effects of temporary differences that give rise to significant portions of deferred tax assets are presented below:
December 31, ---------------------------------- 1997 1996 1995 ---------- ---------- ---------- Deferred tax assets: Accounts receivable, principally due to the allowance for doubtful accounts.............................................................. $ 43,000 $ 43,000 $ 24,000 Inventories, principally due to the allowance for obsolete inventory, and additional costs inventoried for tax purposes..................... 146,000 131,000 96,000 Tangible and intangible assets, principally due to differences in depreciation and amortization......................................... -- -- 45,000 Revenue deferred for financial statement purposes, not for tax reporting purposes.................................................... -- 220,000 241,000 Deferred compensation not currently deductible......................... 122,000 101,000 -- Accrued expenses, not currently deductible............................. 415,000 90,000 75,000 Net operating loss carryforwards....................................... 6,109,000 4,055,000 3,081,000 Business credit carryforwards.......................................... 540,000 386,000 282,000 ---------- ---------- ---------- Total gross deferred tax assets........................................ 7,375,000 5,026,000 3,844,000 Less valuation allowance............................................... 7,368,000 4,967,000 3,844,000 ---------- ---------- ---------- Net deferred tax assets................................................ $ 7,000 $ 59,000 $ -- Deferred tax liabilities: Tangible and intangible assets, principally due to differences in depreciation and amortization.......................... 7,000 59,000 -- ---------- ---------- ---------- Total gross deferred tax liability..................................... 7,000 59,000 -- ---------- ---------- ---------- Net deferred tax assets................................................ $ -- $ -- $ -- ========== ========== ==========
As of December 31, 1997, the Company had net operating loss carryforwards for U.S. federal, U.K., and California state tax return purposes of approximately $15,693,000, $1,808,000, and $3,034,000, respectively. The federal and California net operating loss carryforwards expire in the years 2012 and 2002, respectively. The Company's U.K. net operating loss carryforward is available indefinitely to offset its U.K. trading profits arising from distribution operations. The difference between the tax loss carryforwards and the accumulated deficit primarily relates to timing differences in the recognition of deferred revenue, accrued compensation, and certain reserves. The Internal Revenue Code of 1986 and the California Conformity Act of 1987 substantially restrict the ability of a corporation to utilize existing net operating losses and credits in the event of an "ownership change". The several issuances of preferred stock and the initial public offering have resulted in multiple ownership changes since inception of the Company. Approximately $10,300,000 of the federal net operating loss carryforward will be subject to an annual limitation in the aggregate of $800,000. Any unused annual limitation can be carried over and added to the succeeding year's annual limitation within the allowable carryforward period. 43 APPLIED IMAGING CORP. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS--(Continued) (8) COMMITMENTS The Company has various noncancelable operating leases for equipment, vehicles, and facilities expiring through 2005. The facility leases generally contain renewal options for periods ranging from two to three years and require the Company to pay all executory costs such as maintenance, property taxes, and insurance. Rent expense under operating leases aggregated $351,000, $264,000, and $326,000 during 1997, 1996 and 1995, respectively. The Company's primary lease commitments are for its facilities in the United Kingdom, which aggregate approximately (Pounds)114,000 per year through 2002, with a five-year renewal option held by the Company, and for its facilities in the United States, which aggregate approximately $248,000 and $26,000 for 1998 and 1999, respectively. The Company has a capital lease commitment of $151,000, including interest of $28,000 at 10%, which calls for annual payments of $34,000 through the year 2001 and a payment of $15,000 in 2002. In October 1997, the Company entered into an exclusive worldwide licensing agreement with the University of Cambridge for the commercialization of DNA- probe technology recently developed by the Cambridge researchers. The agreement requires minimum annual royalty payments of $30,000 and the payment for specific research related projects. The agreement will remain in full force and effect until the expiration of the last patent right or ten years whichever is the later (9) EMPLOYEE BENEFIT PLANS In January, 1994, the Company implemented a retirement savings and investment plan that is intended to qualify under Section 401(k) of the Internal Revenue Code (the 401(k) Plan) covering all of the Company's United States-based employees. An employee may elect to defer, in the form of contributions to the 401(k) Plan on his or her behalf, up to 15% of the total compensation that would otherwise be paid to the employee, not to exceed the amount allowed by applicable Internal Revenue Service guidelines. The Company matches 100% of the amounts deferred by the employee participants up to 3% of such employee's total compensation and such matching amounts vest over a three-year period from the initial participation date. Contributions by employees or by the Company to the 401(k) Plan, and income earned on plan contributions, are not taxable to employees until withdrawn from the 401(k) Plan. Contributions by the Company are deductible by the Company when made. The Company contributed $85,000, $69,000 and $51,000 in 1997, 1996 and 1995, respectively. The Company's United Kingdom-based employees are covered by retirement savings plans (the International Retirement Plans). Under such plans, an employee may elect to make contributions of 3.5% of such employee's earnings. Amounts contributed by the Company range 5.5% to 10.5% of such employee's earnings. During 1997, 1996 and 1995, respectively, the Company made contributions to the Internal Retirement Plans totaling $60,000, $47,000 and $43,000, respectively. Contributions by employees or by the Company to the International Retirement Plans, and income earned on plan contributions, are not taxable to employees until withdrawn from such plans. Contributions by the Company are deductible by the Company when made. 44 APPLIED IMAGING CORP. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS--(Continued) (10) Other Income, Net The components of other income, net are as follows:
December 31, ---------------------------------- 1997 1996 1995 ---------- ---------- ---------- Interest income.................. $ 595,000 $ 208,000 $ 143,000 Interest expense................. (49,000) (86,000) (110,000) Gain (loss) on foreign exchange.. (163,000) (112,000) 34,000 Miscellaneous income............. 15,000 4,000 4,000 --------- --------- --------- $ 398,000 $ 14,000 $ 71,000 ========= ========= =========
(11) Foreign Operations The Company markets its products worldwide from its operations in the United States and the United Kingdom and performs research and development in the United States and Israel. Sales from the United States are primarily to customers within the United States. Revenues in the United Kingdom resulted from drop shipments of product from the United States directly to customers and from direct shipments from the United Kingdom. Selected financial data by primary geographic area for the years ended December 31, 1997, 1996, and 1995 follow. In 1995 and 1996, operating losses incurred by Israel are offset by funding received in connection with the grant discussed at Note 12.
Year Ended December 31, ---------------------------------------- 1997 1996 1995 ------------ ------------- ----------- Sales to unaffiliated customers: United States................... $ 5,328,000 $ 4,797,000 $ 4,254,000 United Kingdom.................. 7,806,000 7,125,000 6,544,000 ----------- ----------- ----------- Total........................ $13,134,000 $11,922,000 $10,798,000 =========== =========== =========== Operating loss: United States................... $ 6,856,000 $ 2,794,000 $ 2,548,000 United Kingdom.................. 546,000 31,000 69,000 Israel.......................... 508,000 70,000 -- ----------- ----------- ----------- Total........................ $ 7,910,000 $ 2,895,000 $ 2,617,000 =========== =========== =========== December 31, ---------------------------------------- 1997 1996 1995 ----------- ----------- ----------- Total assets: United States................... $11,051,000 $13,032,000 $ 6,473,000 United Kingdom.................. 3,438,000 3,046,000 2,755,000 Israel.......................... 225,000 395,000 145,000 ----------- ----------- ----------- Total........................ $14,714,000 $16,473,000 $ 9,373,000 =========== =========== =========== Net assets: United States................... $ 8,414,000 $11,393,000 $ 4,183,000 United Kingdom.................. 1,073,000 736,000 491,000 Israel.......................... (544,000) (124,000) 40,000 ----------- ----------- ----------- Total........................ $ 8,943,000 $12,005,000 $ 4,714,000 =========== =========== ===========
Substantially all of the sales within the U.K. are denominated in British pounds. The Company generally does not enter into any arrangements to hedge the effect of foreign currency changes on its foreign currency denominated assets and liabilities. 45 APPLIED IMAGING CORP. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS--(Continued) (12) Research and Development Arrangement During 1995, the Company was awarded a grant by the Israel-United States Binational Industrial Research and Development (BIRD) Foundation. With the funding received from the grant, the Company began research operations in its Israel subsidiary relating to its fetal cell program. All funds received by the Company in advance of performing the related research and development are recorded as a deferred credit in the accompanying consolidated balance sheets and, as expenses are incurred, the deferred credit is depleted. Over the life of the grant, the Company could receive up to $543,000 in matching funds. These funds, as well as any accrued interest, will be required to be paid back to the BIRD Foundation if future revenues are realized from the related research and development activities, at the rate of 2 1/2 % of such future revenues generated in the first year such revenues occur, and 5% of revenues in succeeding years, over a six-year period, up to a maximum of 150% of the funds received. As of December 31, 1997, the Company has received a total of $492,000 in funding and no further funding is expected. The Company has recognized credits to its expenses of approximately $34,000 during 1997, $361,000 during 1996 and $97,000 during 1995. (13) PRIVATE PLACEMENT TRANSACTION On May 22, 1997, the Company consummated a private sale of 796,020 shares of its Common Stock to certain partnerships affiliated with New Enterprise Associates, a principal owner of the Company at $5.025 per share. The price per share was calculated as the average of the closing prices of the Company's Common Stock as reported on the Nasdaq National Market System for the previous five trading days prior to the day of the transaction closing date. Thomas C. McConnell, a director of the company, is an affiliate of New Enterprise Associates. In connection with this transaction, the Company also issued warrants, which may be exercised within a three-year period ending May 21, 2000 to acquire an aggregate of 173,010 shares of the Company's Common Stock at a purchase price of $5.78 per share. The Company allocated a portion of the proceeds to the warrants based on the fair value using the Black-Scholes model and such amount is included within common stock. ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE None. 46 PART III Certain information required by Part III is omitted from this Report on Form 10-K in that the Registrant will file a definitive proxy statement within 120 days after the end of its fiscal year pursuant to Regulation 14A with respect to the 1998 Annual Meeting of Stockholders (the ''Proxy Statement'') and certain information included therein is incorporated herein by reference. ITEM 10. DIRECTORS AND EXECUTIVE OFFICERS OF THE REGISTRANT Certain of the information required by this item relating to directors is incorporated by reference to the information under the caption ''Proposal No. 1 - -- Election of Directors'' in the Proxy Statement. The executive officers of the Registrant, who are elected by the board of directors, are as follows: NAME Age POSITION - ------------------------------ ----- ------------------------------------ Jack Goldstein, Ph.D. 50 Chief Executive Officer and President Abraham I. Coriat (1)......... 49 Chairman of the Board of Directors Michael W. Burgett, Ph.D...... 52 Executive Vice President Leslie G. Grant, Ph.D......... 45 Executive Vice President Neil E. Woodruff (2).......... 51 Chief Financial Officer and Secretary Carl Hull..................... 40 Vice President Worldwide Marketing (1) Mr. Coriat resigned as Chief Executive Officer in April 1997 and was replaced by Dr. Goldstein. Mr. Coriat resigned as Chairman of the Board and as a Director in February 1998. (2) Mr. Woodruff resigned as Chief Financial Officer and Secretary in February 1998. Jack Goldstein, Ph.D. joined the Company as Chief Executive Officer and President in April 1997. Dr. Goldstein has 23 years of management experience at leading healthcare companies. From 1986 to 1997, Dr. Goldstein worked for Johnson & Johnson in various executive management positions including President of Ortho Diagnostic Systems and Executive Vice President of Professional Diagnostics at Johnson & Johnson World Headquarters. Prior to his tenure at Johnson & Johnson, Dr. Goldstein served in management positions at Baxter Healthcare Corporation and American Home Products Corporation. Dr. Goldstein holds a B.A. degree in Biology from Rider University, an M.S. in Immunology and a Ph.D. in Microbiology from St. John's University. Abraham I. Coriat the founder of the Company, has been with the Company since 1986. He served as Chief Executive Officer until April 1997, and Chairman of the Board until his resignation in February 1998. From 1981 to 1986, he served as Business Area Manager and Engineering Manager for International Imaging Systems in their medical and industrial imaging divisions. Mr. Coriat has 23 years of experience in the imaging and medical industry, including various senior engineering positions in England, Belgium and Italy. He holds an Electrical Engineering degree from INSA (Institut National de Sciences Appliquees), France. Michael W. Burgett Ph.D., joined the Company as President of the Genetic Diagnostics Division in February 1996. In 1997 he became an Executive Vice President of the Company. Dr. Burgett has 23 years of experience in the medical diagnostics industry, including 14 years in senior management positions. From 1987 to 1996, Dr. Burgett held various general management, operations and product development positions with Ortho Diagnostic System Inc., a Johnson & Johnson Company, most recently acting as Vice President and General Manager of their blood bank business. Prior to that, Dr. Burgett held various research and development and program management positions with SmithKline Beckman, Inc., International Diagnostics Technology, Inc., and BioRad Laboratories, Inc. Dr. Burgett holds a B.A. and an M.A. in Biology from San Francisco State University and a Ph.D. in Chemistry from the University of Texas at Austin. 47 Leslie G. Grant Ph.D., has been President and Chief Operating Officer of the Company's Cytogenetics Division since February 1992. In 1997 he became and Executive Vice President of the Company. He joined the Company in October 1991 as Managing Director of Applied Imaging International Ltd. From 1980 to 1991, Dr. Grant held various general management and senior engineering positions with GEC-Marconi. Dr. Grant has 20 years experience in the instrumentation and medical industry, including 11 years in senior management positions. Dr. Grant holds a B.S. in Mathematics and a Ph.D. in Mathematics and Electronic Engineering from the University of Hull, United Kingdom. Neil E. Woodruff served as Chief Financial Officer of the Company from April 1990 until his resignation in February 1998, and Secretary from 1993 until February 1998. Mr. Woodruff has 25 years experience in finance and the high technology industry. From 1983 to 1990, Mr. Woodruff held various financial and general management positions with General Signal Corp. Prior to that, Mr. Woodruff held various finance posts with Epitaxy, Inc., National Semiconductor and General Instrument Corp. Mr. Woodruff holds a B.S. in Finance from the University of Santa Clara. Mr. Woodruff resigned from the Company in February 1998. Carl Hull joined the Company as Vice President of Worldwide Marketing in August 1997. Prior to joining the Company, Mr. Hull served as Vice President of Marketing and Business Development for Ventana Medical Systems. From 1982 to 1996, he served in various marketing and sales management positions at Abbott Laboratories, including Vice President and General Manager of Abbott Laboratories, Puerto Rico. He also served as Marketing Manager Far-East, Marketing manager for Hematology Products, District Sales Manager as well as Product Manager for several diagnostic product lines. Mr. Hull received his MBA from University of Chicago and a B.A. in Political Science and International Relations at Johns Hopkins University. 48 ITEM 11. EXECUTIVE COMPENSATION The information required by this item is incorporated by reference to the information under the caption ''Executive Compensation'' in the Proxy Statement. ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT The information required by this item is incorporated by reference to the information under the caption ''Record Date and Stock Ownership'' in the Proxy Statement. ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS The information required by this item is incorporated by reference to the information under the caption ''Certain Transactions'' in the Proxy Statement. 49 PART IV Item 14. EXHIBITS, FINANCIAL STATEMENT SCHEDULES, AND REPORTS ON FORM 8-K (a) 1. Financial Statements The following Financial Statements of Applied Imaging Corp. and Report of KPMG Peat Marwick LLP, have been provided as Item 8, above: Report of KPMG Peat Marwick LLP, Certified Public Accountants Consolidated Balance Sheets, 1997 and 1996 Consolidated Statements of Operations, Years Ended December 31, 1997, 1996 and 1995 Consolidated Statements of Stockholders' Equity, Years Ended December 31, 1997, 1996 and 1995 Consolidated Statements of Cash Flows, Years Ended December 31, 1997, 1996 and 1995 Notes to Consolidated Financial Statements 2. FINANCIAL STATEMENT SCHEDULES The financial statement schedule entitled ''Valuation and Qualifying Accounts'' is included at page 54 of this Form 10-K. All other schedules are omitted because they are not applicable or the required information is shown in the Financial Statements or the notes thereto. 3. EXHIBITS Refer to (c) below. (b) REPORTS ON FORM 8-K The Company was not required to and did not file any reports on Form 8-K during the three months ended December 31, 1997. (c) EXHIBITS
EXHIBIT NO. Description - ---------------- ----------------------------------------------------------------------------------------------- 3.1(1) Restated Certificate of Incorporation of the Registrant. 3.2 Bylaws of the Registrant, as amended. 4.1(1) Specimen Common Stock Certificate. 10.1(1) Form of Indemnification Agreement for directors and officers. 10.2(1) Amended and Restated 1988 Incentive Stock Option Plan and form of agreement thereunder. 10.3(1) 1994 Director Option Plan and form of subsequent agreement thereunder. 10.4(1) Employee Stock Purchase Plan. 10.5(1) Amended and Restated Registration Rights Agreements. 10.6(1) License Agreement dated December 1, 1993 between the Registrant and Chronomed, Inc. 10.7(1) Assignment dated December 1, 1993 by and between the Registrant and Alex Saunders, M.D. 10.8(1) Lease dated February 15, 1994 for the Registrant's headquarters in Santa Clara, CA. 10.9(a)(1) Lease for Site No. BT. 2003/1A, Hylton Park, Sunderland, England, between English Industrial Estates Corporation and Applied Imaging International Ltd., dated June 12, 1992. 10.9(b)(1) Lease for Site No. BT.2003/3A, Hylton Park, Sunderland, England, between English Industrial Estates Corporation and Applied Imaging International Ltd., dated June 12, 1992.
50
EXHIBIT NO. Description - ------------- -------------------------------------------------------------------------------------------------- 10.9(c)(1) Underlease for Site No. BT.2003/1A between Applied Imaging International Ltd. And RTC North Limited, dated February 14, 1996. 10.9(d)(1) Supplement to Underlease for Site No. BT.2003/1A between Applied Imaging International Ltd. And RTC North Limited, dated February 14, 1996. 10.10(1) Employment Letter Agreement dated August 12, 1991 between the Registrant and Leslie G. Grant. 10.11(1) Amendment to Employment Letter Agreement between the Registrant and Leslie G. Grant, dated February 12, 1996. 10.12(1) Employment Letter Agreement dated January 12, 1996 between the Registrant and Michael W. Burgett, Ph.D., and supplement thereto, dated January 20, 1996. 10.13(1) Know-How License Agreement dated November 1989 between Medical Research Council and Shandon Scientific Limited (assigned to the Registrant in November 1989), as amended, July 5, 1994. 10.14(1) Cooperative Research and Development Agreement, dated June 10, 1995 between Registrant and the National Institute of Health. 10.15(1) Supply & Distribution Agreement dated March 3, 1994 between Cytocell Ltd. And Registrant. 10.16(1) Research Purchase Agreement dated March 26, 1996 between Pharmacia Biotech AB and Registrant. 10.17(1) Development Agreement dated February 5, 1996 between Em Industries and Registrant. 10.18(1) Security and Loan Agreement dated September 5, 1995 between Registrant and Imperial Bank. 10.19(1) Extension to Security and Loan Agreement dated September 16, 1996 between Registrant and Imperial. 10.20(1) Agreement dated October 3, 1996 between Mitchell S. Golbus and the Registrant. 10.21(2) License Agreement dated October 24, 1997 between Cambridge University and the Registrant. 10.22 Employment Letter Agreement dated July 21, 1997 between the Company and Carl Hull. 10.23 Employment Letter Agreement dated April 2, 1997 between the Company and Jack Goldstein, Ph.D. and amendment dated April 4, 1997. 21.1(1) List of Subsidiaries of the Registrant. 23.1 Consent of KPMG Peat Marwick LLP. 24.1 Power of Attorney (included at page 52 below). 27.1 Financial Data Schedule.
- -------------- (1) Filed as an Exhibit to the Company's Registration Statement on Form S-1 (File No. 333-06703) and incorporated herein by reference. (2) Confidential Treatment requested for portions of this exhibit. 51 SIGNATURES Pursuant to the requirements of the Securities Act, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. Applied Imaging Corp. Date: March 31, 1998 By: /s/ Jack Goldstein ----------------------- JACK GOLDSTEIN Chief Executive Officer POWER OF ATTORNEY KNOW ALL MEN AND WOMEN BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Jack Goldstein his or her attorney-in- fact, with the power of substitution, for him or her in any and all capacities, to sign any amendments to this Report on Form 10-K, and to file the same, with exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, hereby ratifying and confirming all that said attorneys-in-fact, or his or her substitute or substitutes, may do or cause to be done by virtue thereof. Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Registrant and in the capacities and on the date indicated.
Signatures TITLE DATE - --------------------------------------- ------------------------------- ------------------ /S/ Jack Goldstein Chief Executive Officer and March 31, 1998 - ---------------------------------- Director (Principal (JACK GOLDSTEIN) Executive Officer) /S/ Michael J. Braden Corporate Controller March 31, 1998 - ---------------------------------- (Principal (MICHAEL J. BRADEN) Accounting Officer) /s/ John F. Blakemore, Jr. Director March 31, 1998 - ---------------------------------- (JOHN F. BLAKEMORE, JR.) Director - ---------------------------------- (GILBERT J.R. MCCABE)
52
Signatures TITLE DATE - --------------------------------------- ------------------------------- ------------------ /s/ Thomas C. McConnell Director March 31, 1998 - ---------------------------------- (THOMAS C. MCCONNELL) /s/ Andre F. Marion Director March 31, 1998 - ---------------------------------- (ANDRE F. MARION) /s/ Robert C. Miller Director March 31, 1998 - ---------------------------------- (ROBERT C. MILLER) Director - ---------------------------------- (G. KIRK RAAB)
53 APPLIED IMAGING CORP. SCHEDULE II-VALUATION AND QUALIFYING ACCOUNTS (IN THOUSANDS)
BALANCE AT CHARGED TO BALANCE AT BEGINNING OF COSTS AND DEDUCTIONS/ END OF YEAR EXPENSES RECOVERIES YEAR -------------- -------------- -------------- -------------- Allowance for doubtful accounts Year ended December 31, 1997 $228 $10 $47 $191 Year ended December 31, 1996 $166 $76 $14 $228
54 EXHIBIT INDEX
Exhibit No. DESCRIPTION - ------------ -------------------------------------------------------------------------------------------------- 3.2 Bylaws of the Registrant, as amended. 10.21 License Agreement dated October 24, 1997 between Cambridge University and the Registrant. 10.22 Employment Letter Agreement dated July 21, 1997 between the Company and Carl Hull. 10.23 Employment Letter Agreement dated April 2, 1997 between the Company and Jack Goldstein, Ph.D. and amendment dated April 4, 1997. 24.1 Power of Attorney, included at page 52, above. 27.1 Financial Data Schedule.
55
EX-3.2 2 BYLAWS OF THE REGISTRANT, AS AMENDED. Exhibit 3.2 BYLAWS OF APPLIED IMAGING CORP. (a Delaware corporation) BYLAWS OF APPLIED IMAGING CORP. (a Delaware corporation) TABLE OF CONTENTS
Page ARTICLE I - CORPORATE OFFICES............................................... 1 1.1 REGISTERED OFFICE............................................. 1 1.2 OTHER OFFICES................................................. 1 ARTICLE II - MEETINGS OF STOCKHOLDERS....................................... 1 2.1 PLACE OF MEETINGS............................................. 1 2.2 ANNUAL MEETING................................................ 1 2.3 SPECIAL MEETING............................................... 1 2.4 NOTICE OF STOCKHOLDERS' MEETINGS.............................. 2 2.5 ADVANCE NOTICE OF STOCKHOLDER NOMINEES AND STOCKHOLDER BUSINESS........................................ 2 2.6 MANNER OF GIVING NOTICE; AFFIDAVIT OF NOTICE.................. 3 2.7 QUORUM........................................................ 4 2.8 ADJOURNED MEETING; NOTICE..................................... 4 2.9 VOTING........................................................ 4 2.10 RECORD DATE FOR STOCKHOLDER NOTICE; VOTING.................... 5 2.11 PROXIES....................................................... 5 2.12 ORGANIZATION.................................................. 6 2.13 LIST OF STOCKHOLDERS ENTITLED TO VOTE......................... 6 2.14 WAIVER OF NOTICE.............................................. 6 ARTICLE III - DIRECTORS..................................................... 7 3.1 POWERS........................................................ 7 3.2 NUMBER OF DIRECTORS........................................... 7 3.3 ELECTION AND TERM OF OFFICE OF DIRECTORS...................... 7 3.4 RESIGNATION AND VACANCIES..................................... 7 3.5 REMOVAL OF DIRECTORS.......................................... 8 3.6 PLACE OF MEETINGS; MEETINGS BY TELEPHONE...................... 9 3.7 REGULAR MEETINGS.............................................. 9 3.8 SPECIAL MEETINGS; NOTICE...................................... 9
-i- TABLE OF CONTENTS (Continued)
Page ---- 3.9 QUORUM....................................................... 9 3.10 WAIVER OF NOTICE............................................. 10 3.11 ADJOURNMENT.................................................. 10 3.12 NOTICE OF ADJOURNMENT........................................ 10 3.13 BOARD ACTION BY WRITTEN CONSENT WITHOUT A MEETING............ 10 3.14 FEES AND COMPENSATION OF DIRECTORS........................... 10 3.15 APPROVAL OF LOANS TO OFFICERS................................ 11 ARTICLE IV - COMMITTEES.................................................... 11 4.1 COMMITTEES OF DIRECTORS...................................... 11 4.2 MEETINGS AND ACTION OF COMMITTEES............................ 12 4.3 COMMITTEE MINUTES............................................ 12 ARTICLE V - OFFICERS....................................................... 12 5.1 OFFICERS..................................................... 12 5.2 ELECTION OF OFFICERS......................................... 12 5.3 SUBORDINATE OFFICERS......................................... 13 5.4 REMOVAL AND RESIGNATION OF OFFICERS.......................... 13 5.5 VACANCIES IN OFFICES......................................... 13 5.6 CHAIRMAN OF THE BOARD........................................ 13 5.7 PRESIDENT.................................................... 13 5.8 VICE PRESIDENTS.............................................. 14 5.9 SECRETARY.................................................... 14 5.10 CHIEF FINANCIAL OFFICER...................................... 14 5.11 ASSISTANT SECRETARY.......................................... 15 5.12 ADMINISTRATIVE OFFICERS...................................... 15 5.13 AUTHORITY AND DUTIES OF OFFICERS............................. 15 ARTICLE VI - INDEMNIFICATION OF DIRECTORS, OFFICERS, EMPLOYEES AND OTHER AGENTS................................................. 16 6.1 INDEMNIFICATION OF DIRECTORS AND OFFICERS.................... 16 6.2 INDEMNIFICATION OF OTHERS.................................... 17 6.3 INSURANCE.................................................... 17
-ii- TABLE OF CONTENTS (Continued)
Page ---- ARTICLE VII - RECORDS AND REPORTS.......................................... 17 7.1 MAINTENANCE AND INSPECTION OF RECORDS........................ 17 7.2 INSPECTION BY DIRECTORS...................................... 18 7.3 ANNUAL STATEMENT TO STOCKHOLDERS............................. 18 7.4 REPRESENTATION OF SHARES OF OTHER CORPORATIONS............... 18 7.5 CERTIFICATION AND INSPECTION OF BYLAWS....................... 18 ARTICLE VIII - GENERAL MATTERS............................................. 18 8.1 RECORD DATE FOR PURPOSES OTHER THAN NOTICE AND VOTING..................................................... 18 8.2 CHECKS; DRAFTS; EVIDENCES OF INDEBTEDNESS.................... 19 8.3 CORPORATE CONTRACTS AND INSTRUMENTS: HOW EXECUTED........... 19 8.4 STOCK CERTIFICATES; TRANSFER; PARTLY PAID SHARES............. 19 8.5 SPECIAL DESIGNATION ON CERTIFICATES.......................... 20 8.6 LOST CERTIFICATES............................................ 20 8.7 TRANSFER AGENTS AND REGISTRARS............................... 21 8.8 CONSTRUCTION; DEFINITIONS.................................... 21 ARTICLE IX - AMENDMENTS.................................................... 21
-iii- BYLAWS ------ OF -- APPLIED IMAGING CORP. --------------------- (a Delaware corporation) ARTICLE I CORPORATE OFFICES ----------------- 1.1 REGISTERED OFFICE ----------------- The registered office of the corporation shall be fixed in the certificate of incorporation of the corporation. 1.2 OTHER OFFICES ------------- The board of directors may at any time establish branch or subordinate offices at any place or places where the corporation is qualified to do business. ARTICLE II MEETINGS OF STOCKHOLDERS ------------------------ 2.1 PLACE OF MEETINGS ----------------- Meetings of stockholders shall be held at any place within or outside the State of Delaware designated by the board of directors. In the absence of any such designation, stockholders' meetings shall be held at the principal executive office of the corporation. 2.2 ANNUAL MEETING -------------- The annual meeting of stockholders shall be held each year on a date and at a time designated by the board of directors. In the absence of such designation, the annual meeting of stockholders shall be held on the second Tuesday of May in each year at 10:00 a.m. However, if such day falls on a legal holiday, then the meeting shall be held at the same time and place on the next succeeding full business day. At the meeting, directors shall be elected, and any other proper business may be transacted. 2.3 SPECIAL MEETING --------------- A special meeting of the stockholders may be called at any time by the board of directors, or by the chairman of the board, or by the president, or by one or more stockholders holding shares in the aggregate entitled to cast not less than ten percent (10%) of the votes at that meeting. No other person or persons are permitted to call a special meeting. If a special meeting is called by any person or persons other than the board of directors, then the request shall be in writing, specifying the time of such meeting and the general nature of the business proposed to be transacted, and shall be delivered personally or sent by registered mail or by telegraphic or other facsimile transmission to the chairman of the board, the president, or the secretary of the corporation. The officer receiving the request shall cause notice to be promptly given to the stockholders entitled to vote, in accordance with the provisions of Sections 2.4 and 2.6 of these bylaws, that a meeting will be held at the time requested by the person or persons calling the meeting, so long as that time is not less than thirty-five (35) nor more than sixty (60) days after the receipt of the request. If the notice is not given within twenty (20) days after receipt of the request, then the person or persons requesting the meeting may give the notice. Nothing contained in this paragraph of this Section 2.3 shall be construed as limiting, fixing or affecting the time when a meeting of stockholders called by action of the board of directors may be held. 2.4 NOTICE OF STOCKHOLDERS' MEETINGS -------------------------------- All notices of meetings of stockholders shall be sent or otherwise given in accordance with Section 2.6 of these bylaws not less than ten (10) nor more than sixty (60) days before the date of the meeting. The notice shall specify the place, date and hour of the meeting and (i) in the case of a special meeting, the purpose or purposes for which the meeting is called (no business other than that specified in the notice may be transacted) or (ii) in the case of the annual meeting, those matters which the board of directors, at the time of giving the notice, intends to present for action by the stockholders (but any proper matter may be presented at the meeting for such action). The notice of any meeting at which directors are to be elected shall include the name of any nominee or nominees who, at the time of the notice, the board intends to present for election. 2.5 ADVANCE NOTICE OF STOCKHOLDER NOMINEES AND STOCKHOLDER BUSINESS --------------------------------------------------------------- Subject to the rights of holders of any class or series of stock having a preference over the Common Stock as to dividends or upon liquidation, (a) nominations for the election of directors, and (b) business proposed to be brought before any stockholder meeting may be made by the board of directors or proxy committee appointed by the board of directors or by any stockholder entitled to vote in the election of directors generally if such nomination or business proposed is otherwise proper business before such meeting. However, any such stockholder may nominate one or more persons for election as directors at a meeting or propose business to be brought before a meeting, or both, only if such stockholder has given timely notice in proper written form of their intent to make such nomination or nominations or to propose such business. To be timely, such stockholder's notice -2- must be delivered to or mailed and received at the principal executive offices of the corporation not less than one hundred twenty (120) calendar days in advance of the date specified in the corporation's proxy statement released to stockholders in connection with the previous year's annual meeting of stockholders; provided, however, that in the event that no annual meeting was held in the previous year or the date of the annual meeting has been changed by more than thirty (30) days from the date contemplated at the time of the previous year's proxy statement, notice by the stockholder to be timely must be so received a reasonable time before the solicitation is made. To be in proper form, a stockholder's notice to the secretary shall set forth: (i) the name and address of the stockholder who intends to make the nominations or propose the business and, as the case may be, of the person or persons to be nominated or of the business to be proposed; (ii) a representation that the stockholder is a holder of record of stock of the corporation entitled to vote at such meeting and, if applicable, intends to appear in person or by proxy at the meeting to nominate the person or persons specified in the notice; (iii) if applicable, a description of all arrangements or understandings between the stockholder and each nominee and any other person or persons (naming such person or persons) pursuant to which the nomination or nominations are to be made by the stockholder; (iv) such other information regarding each nominee or each matter of business to be proposed by such stockholder as would be required to be included in a proxy statement filed pursuant to the proxy rules of the Securities and Exchange Commission had the nominee been nominated, or intended to be nominated, or the matter been proposed, or intended to be proposed by the board of directors; and (v) if applicable, the consent of each nominee to serve as director of the corporation if so elected. The chairman of the meeting shall refuse to acknowledge the nomination of any person or the proposal of any business not made in compliance with the foregoing procedure. 2.6 MANNER OF GIVING NOTICE; AFFIDAVIT OF NOTICE -------------------------------------------- Written notice of any meeting of stockholders shall be given either personally or by first-class mail or by telegraphic or other written communication. Notices not personally delivered shall be sent charges prepaid and shall be addressed to the stockholder at the address of that stockholder appearing on the books of the corporation or given by the stockholder to the corporation for the purpose of notice. Notice shall be deemed to have been given at the time when delivered personally or deposited in the mail or sent by telegram or other means of written communication. -3- An affidavit of the mailing or other means of giving any notice of any stockholders' meeting, executed by the secretary, assistant secretary or any transfer agent of the corporation giving the notice, shall be prima facie evidence of the giving of such notice. 2.7 QUORUM ------ The holders of a majority in voting power of the stock issued and outstanding and entitled to vote thereat, present in person or represented by proxy, shall constitute a quorum at all meetings of the stockholders for the transaction of business except as otherwise provided by statute or by the certificate of incorporation. If, however, such quorum is not present or represented at any meeting of the stockholders, then either (i) the chairman of the meeting or (ii) the stockholders entitled to vote thereat, present in person or represented by proxy, shall have power to adjourn the meeting in accordance with Section 2.7 of these bylaws. When a quorum is present at any meeting, the vote of the holders of a majority of the stock having voting power present in person or represented by proxy shall decide any question brought before such meeting, unless the question is one upon which, by express provision of the laws of the State of Delaware or of the certificate of incorporation or these bylaws, a different vote is required, in which case such express provision shall govern and control the decision of the question. If a quorum be initially present, the stockholders may continue to transact business until adjournment, notwithstanding the withdrawal of enough stockholders to leave less than a quorum, if any action taken is approved by a majority of the stockholders initially constituting the quorum. 2.8 ADJOURNED MEETING; NOTICE ------------------------- When a meeting is adjourned to another time and place, unless these bylaws otherwise require, notice need not be given of the adjourned meeting if the time and place thereof are announced at the meeting at which the adjournment is taken. At the adjourned meeting the corporation may transact any business that might have been transacted at the original meeting. If the adjournment is for more than thirty (30) days, or if after the adjournment a new record date is fixed for the adjourned meeting, a notice of the adjourned meeting shall be given to each stockholder of record entitled to vote at the meeting. 2.9 VOTING ------ The stockholders entitled to vote at any meeting of stockholders shall be determined in accordance with the provisions of Section 2.11 of these bylaws, subject to the provisions of Sections 217 and 218 of the General Corporation Law of Delaware (relating to voting rights of fiduciaries, pledgors and joint owners, and to voting trusts and other voting agreements). Except as may be otherwise provided in the certificate of incorporation or these bylaws, each stockholder shall be entitled to one vote for each share of capital stock held by such stockholder and stockholders shall not be entitled to cumulate their votes in the election of directors or with respect to any matter submitted to a vote of the stockholders. -4- Notwithstanding the foregoing, if the stockholders of the corporation are entitled, pursuant to Sections 2115 and 301.5 of the California Corporations Code, to cumulate their votes in the election of directors, each such stockholder shall be entitled to cumulate votes (i.e., cast for any candidate a number of votes greater than the number of votes that such stockholder normally is entitled to cast) only if the candidates' names have been properly placed in nomination (in accordance with these bylaws) prior to commencement of the voting, and the stockholder requesting cumulative voting has given notice prior to commencement of the voting of the stockholder's intention to cumulate votes. If cumulative voting is properly requested, each holder of stock, or of any class or classes or of a series or series thereof, who elects to cumulate votes shall be entitled to as many votes as equals the number of votes that (absent this provision as to cumulative voting) he or she would be entitled to cast for the election of directors with respect to his or her shares of stock multiplied by the number of directors to be elected by him, and he or she may cast all of such votes for a single director or may distribute them among the number to be voted for, or for any two or more of them, as he or she may see fit. 2.10 RECORD DATE FOR STOCKHOLDER NOTICE; VOTING ------------------------------------------ For purposes of determining the stockholders entitled to notice of any meeting or to vote thereat, the board of directors may fix, in advance, a record date, which shall not precede the date upon which the resolution fixing the record date is adopted by the board of directors and which shall not be more than sixty (60) days nor less than ten (10) days before the date of any such meeting, and in such event only stockholders of record on the date so fixed are entitled to notice and to vote, notwithstanding any transfer of any shares on the books of the corporation after the record date. If the board of directors does not so fix a record date, the record date for determining stockholders entitled to notice of or to vote at a meeting of stockholders shall be at the close of business on the business day next preceding the day on which notice is given, or, if notice is waived, at the close of business on the business day next preceding the day on which the meeting is held. A determination of stockholders of record entitled to notice of or to vote at a meeting of stockholders shall apply to any adjournment of the meeting unless the board of directors fixes a new record date for the adjourned meeting, but the board of directors shall fix a new record date if the meeting is adjourned for more than thirty (30) days from the date set for the original meeting. The record date for any other purpose shall be as provided in Section 8.1 of these bylaws. 2.11 PROXIES ------- Every person entitled to vote for directors, or on any other matter, shall have the right to do so either in person or by one or more agents authorized by a written proxy signed by the person and filed with the secretary of the corporation, but no such proxy shall be voted or acted upon after three (3) years from its date, unless the proxy provides for a longer period. A proxy shall be deemed signed if the stockholder's name is placed on the proxy (whether by manual signature, typewriting, telegraphic transmission, telefacsimile or otherwise) by the stockholder or the stockholder's attorney-in-fact. The -5- revocability of a proxy that states on its face that it is irrevocable shall be governed by the provisions of Section 212(e) of the General Corporation Law of Delaware. 2.12 ORGANIZATION ------------ The president, or in the absence of the president, the chairman of the board, or, in the absence of the president and the chairman of the board, one of the corporation's vice presidents, shall call the meeting of the stockholders to order, and shall act as chairman of the meeting. In the absence of the president, the chairman of the board, and all of the vice presidents, the stockholders shall appoint a chairman for such meeting. The chairman of any meeting of stockholders shall determine the order of business and the procedures at the meeting, including such matters as the regulation of the manner of voting and the conduct of business. The secretary of the corporation shall act as secretary of all meetings of the stockholders, but in the absence of the secretary at any meeting of the stockholders, the chairman of the meeting may appoint any person to act as secretary of the meeting. 2.13 LIST OF STOCKHOLDERS ENTITLED TO VOTE ------------------------------------- The officer who has charge of the stock ledger of the corporation shall prepare and make, at least ten (10) days before every meeting of stockholders, a complete list of the stockholders entitled to vote at the meeting, arranged in alphabetical order, and showing the address of each stockholder and the number of shares registered in the name of each stockholder. Such list shall be open to the examination of any stockholder, for any purpose germane to the meeting, during ordinary business hours, for a period of at least ten (10) days prior to the meeting, either at a place within the city where the meeting is to be held, which place shall be specified in the notice of the meeting, or, if not so specified, at the place where the meeting is to be held. The list shall also be produced and kept at the time and place of the meeting during the whole time thereof, and may be inspected by any stockholder who is present. 2.14 WAIVER OF NOTICE ---------------- Whenever notice is required to be given under any provision of the General Corporation Law of Delaware or of the certificate of incorporation or these bylaws, a written waiver thereof, signed by the person entitled to notice, whether before or after the time stated therein, shall be deemed equivalent to notice. Attendance of a person at a meeting shall constitute a waiver of notice of such meeting, except when the person attends a meeting for the express purpose of objecting, at the beginning of the meeting, to the transaction of any business because the meeting is not lawfully called or convened. Neither the business to be transacted at, nor the purpose of, any regular or special meeting of the stockholders need be specified in any written waiver of notice unless so required by the certificate of incorporation or these bylaws. -6- ARTICLE III DIRECTORS --------- 3.1 POWERS ------ Subject to the provisions of the General Corporation Law of Delaware and to any limitations in the certificate of incorporation or these bylaws relating to action required to be approved by the stockholders or by the outstanding shares, the business and affairs of the corporation shall be managed and all corporate powers shall be exercised by or under the direction of the board of directors. 3.2 NUMBER OF DIRECTORS ------------------- The board of directors shall not be less than five (5) nor more than nine(9) members. The exact number of directors shall be eight (8) until changed, within the limits specified above by a bylaw amending this Section 3.2 duly adopted by the board of directors or the stockholders. The indefinite number of directors may be changed, or a definite number may be fixed without provision for an indefinite number, by an amendment to this bylaw, duly adopted by the board of directors or by the stockholders, or by a duly adopted amendment to the certificate of incorporation. No reduction of the authorized number of directors shall have the effect of removing any director before that director's term of office expires. Upon the closing of the first sale of the corporation's common stock pursuant to a firmly underwritten registered public offering (the "IPO"), the directors shall be divided into three classes, with the term of office of the first class, which class shall initially consist of three directors, to expire at the first annual meeting of stockholders held after the IPO; the term of office of the second class, which class shall initially consist of three directors, to expire at the second annual meeting of stockholders held after the IPO; the term of office of the third class, which class shall initially consist of two directors, to expire at the third annual meeting of stockholders held after the IPO; and thereafter for each such term to expire at each third succeeding annual meeting of stockholders held after such election. 3.3 ELECTION AND TERM OF OFFICE OF DIRECTORS ---------------------------------------- Except as provided in Section 3.4 of these bylaws, directors shall be elected at each annual meeting of stockholders to hold office until the next annual meeting. Each director, including a director elected or appointed to fill a vacancy, shall hold office until the expiration of the term for which elected and until a successor has been elected and qualified. 3.4 RESIGNATION AND VACANCIES ------------------------- Any director may resign effective on giving written notice to the chairman of the board, the president, the secretary or the board of directors, unless the notice specifies a later time for that resignation to become effective. If the resignation of a director is effective at a future time, the board of directors may elect a successor to take office when the resignation becomes effective. -7- Vacancies in the board of directors may be filled by a majority of the remaining directors, even if less than a quorum, or by a sole remaining director; however, a vacancy created by the removal of a director by the vote of the stockholders or by court order may be filled only by the affirmative vote of a majority of the shares represented and voting at a duly held meeting at which a quorum is present (which shares voting affirmatively also constitute a majority of the required quorum). Each director so elected shall hold office until the next election of the class for which such director shall have been chosen and until a successor has been elected and qualified. Unless otherwise provided in the certificate of incorporation or these bylaws: (i) Vacancies and newly created directorships resulting from any increase in the authorized number of directors elected by all of the stockholders having the right to vote as a single class may be filled by a majority of the directors then in office, although less than a quorum, or by a sole remaining director. (ii) Whenever the holders of any class or classes of stock or series thereof are entitled to elect one or more directors by the provisions of the certificate of incorporation, vacancies and newly created directorships of such class or classes or series may be filled by a majority of the directors elected by such class or classes or series thereof then in office, or by a sole remaining director so elected. If at any time, by reason of death or resignation or other cause, the corporation should have no directors in office, then any officer or any stockholder or an executor, administrator, trustee or guardian of a stockholder, or other fiduciary entrusted with like responsibility for the person or estate of a stockholder, may call a special meeting of stockholders in accordance with the provisions of the certificate of incorporation or these bylaws, or may apply to the Court of Chancery for a decree summarily ordering an election as provided in Section 211 of the General Corporation Law of Delaware. If, at the time of filling any vacancy or any newly created directorship, the directors then in office constitute less than a majority of the whole board (as constituted immediately prior to any such increase), then the Court of Chancery may, upon application of any stockholder or stockholders holding at least ten (10) percent of the total number of the shares at the time outstanding having the right to vote for such directors, summarily order an election to be held to fill any such vacancies or newly created directorships, or to replace the directors chosen by the directors then in office as aforesaid, which election shall be governed by the provisions of Section 211 of the General Corporation Law of Delaware as far as applicable. 3.5 REMOVAL OF DIRECTORS -------------------- Unless otherwise restricted by statute, by the certificate of incorporation or by these bylaws, any director or the entire board of directors may be removed, with or without cause, by the holders of a majority of the shares then entitled to vote at an election of directors; provided, however, that, if and so long as stockholders of the corporation are entitled to cumulative voting, if less than the entire board is to be removed, no director may be removed without cause if the votes cast against his removal would be sufficient to elect him if then cumulatively voted at an election of the entire board of directors. -8- 3.6 PLACE OF MEETINGS; MEETINGS BY TELEPHONE ---------------------------------------- Regular meetings of the board of directors may be held at any place within or outside the State of Delaware that has been designated from time to time by resolution of the board. In the absence of such a designation, regular meetings shall be held at the principal executive office of the corporation. Special meetings of the board may be held at any place within or outside the State of Delaware that has been designated in the notice of the meeting or, if not stated in the notice or if there is no notice, at the principal executive office of the corporation. Any meeting of the board, regular or special, may be held by conference telephone or similar communication equipment, so long as all directors participating in the meeting can hear one another; and all such participating directors shall be deemed to be present in person at the meeting. 3.7 REGULAR MEETINGS ---------------- Regular meetings of the board of directors may be held without notice at such time as shall from time to time be determined by the board of directors. If any regular meeting day shall fall on a legal holiday, then the meeting shall be held at the same time and place on the next succeeding full business day. 3.8 SPECIAL MEETINGS; NOTICE ------------------------ Special meetings of the board of directors for any purpose or purposes may be called at any time by the chairman of the board, the president, any vice president, the secretary or any two directors. Notice of the time and place of special meetings shall be delivered personally or by telephone to each director or sent by first-class mail, telecopy or telegram, charges prepaid, addressed to each director at that director's address as it is shown on the records of the corporation. If the notice is mailed, it shall be deposited in the United States mail at least four (4) days before the time of the holding of the meeting. If the notice is delivered personally or by telephone, telecopy or telegram, it shall be delivered personally or by telephone or to the telegraph company at least forty- eight (48) hours before the time of the holding of the meeting. Any oral notice given personally or by telephone may be communicated either to the director or to a person at the office of the director who the person giving the notice has reason to believe will promptly communicate it to the director. The notice need not specify the purpose or the place of the meeting, if the meeting is to be held at the principal executive office of the corporation. 3.9 QUORUM ------ A majority of the authorized number of directors shall constitute a quorum for the transaction of business, except to adjourn as provided in Section 3.12 of these bylaws. Every act or decision done or made by a majority of the directors present at a duly held meeting at which a quorum is present shall be regarded as the act of the board of directors, subject to the provisions of the certificate of incorporation and applicable law. -9- A meeting at which a quorum is initially present may continue to transact business notwithstanding the withdrawal of directors, if any action taken is approved by at least a majority of the quorum for that meeting. 3.10 WAIVER OF NOTICE ---------------- Notice of a meeting need not be given to any director (i) who signs a waiver of notice, whether before or after the meeting, or (ii) who attends the meeting other than for the express purposed of objecting at the beginning of the meeting to the transaction of any business because the meeting is not lawfully called or convened. All such waivers shall be filed with the corporate records or made part of the minutes of the meeting. A waiver of notice need not specify the purpose of any regular or special meeting of the board of directors. 3.11 ADJOURNMENT ----------- A majority of the directors present, whether or not constituting a quorum, may adjourn any meeting of the board to another time and place. 3.12 NOTICE OF ADJOURNMENT --------------------- Notice of the time and place of holding an adjourned meeting of the board need not be given unless the meeting is adjourned for more than twenty-four (24) hours. If the meeting is adjourned for more than twenty-four (24) hours, then notice of the time and place of the adjourned meeting shall be given before the adjourned meeting takes place, in the manner specified in Section 3.9 of these bylaws, to the directors who were not present at the time of the adjournment. 3.13 BOARD ACTION BY WRITTEN CONSENT WITHOUT A MEETING ------------------------------------------------- Any action required or permitted to be taken by the board of directors may be taken without a meeting, provided that all members of the board individually or collectively consent in writing to that action. Such action by written consent shall have the same force and effect as a unanimous vote of the board of directors. Such written consent and any counterparts thereof shall be filed with the minutes of the proceedings of the board of directors. 3.14 FEES AND COMPENSATION OF DIRECTORS ---------------------------------- Directors and members of committees may receive such compensation, if any, for their services and such reimbursement of expenses as may be fixed or determined by resolution of the board of directors. This Section 3.15 shall not be construed to preclude any director from serving the corporation in any other capacity as an officer, agent, employee or otherwise and receiving compensation for those services. -10- 3.15 APPROVAL OF LOANS TO OFFICERS ----------------------------- The corporation may lend money to, or guarantee any obligation of, or otherwise assist any officer or other employee of the corporation or any of its subsidiaries, including any officer or employee who is a director of the corporation or any of its subsidiaries, whenever, in the judgment of the directors, such loan, guaranty or assistance may reasonably be expected to benefit the corporation. The loan, guaranty or other assistance may be with or without interest and may be unsecured, or secured in such manner as the board of directors shall approve, including, without limitation, a pledge of shares of stock of the corporation. Nothing contained in this section shall be deemed to deny, limit or restrict the powers of guaranty or warranty of the corporation at common law or under any statute. ARTICLE IV COMMITTEES ---------- 4.1 COMMITTEES OF DIRECTORS ----------------------- The board of directors may, by resolution adopted by a majority of the authorized number of directors, designate one (1) or more committees, each consisting of two or more directors, to serve at the pleasure of the board. The board may designate one (1) or more directors as alternate members of any committee, who may replace any absent or disqualified member at any meeting of the committee. The appointment of members or alternate members of a committee requires the vote of a majority of the authorized number of directors. Any committee, to the extent provided in the resolution of the board, shall have and may exercise all the powers and authority of the board, but no such committee shall have the power or authority to (i) amend the certificate of incorporation (except that a committee may, to the extent authorized in the resolution or resolutions providing for the issuance of shares of stock adopted by the board of directors as provided in Section 151(a) of the General Corporation Law of Delaware, fix the designations and any of the preferences or rights of such shares relating to dividends, redemption, dissolution, any distribution of assets of the corporation or the conversion into, or the exchange of such shares for, shares of any other class or classes or any other series of the same or any other class or classes of stock of the corporation), (ii) adopt an agreement of merger or consolidation under Sections 251 or 252 of the General Corporation Law of Delaware, (iii) recommend to the stockholders the sale, lease or exchange of all or substantially all of the corporation's property and assets, (iv) recommend to the stockholders a dissolution of the corporation or a revocation of a dissolution or (v) amend the bylaws of the corporation; and, unless the board resolution establishing the committee, the bylaws or the certificate of incorporation expressly so provide, no such committee shall have the power or authority to declare a dividend, to authorize the issuance of stock, or to adopt a certificate of ownership and merger pursuant to Section 253 of the General Corporation Law of Delaware. -11- 4.2 MEETINGS AND ACTION OF COMMITTEES --------------------------------- Meetings and actions of committees shall be governed by, and held and taken in accordance with, the following provisions of Article III of these bylaws: Section 3.6 (place of meetings; meetings by telephone), Section 3.8 (regular meetings), Section 3.9 (special meetings; notice), Section 3.10 (quorum), Section 3.11 (waiver of notice), Section 3.12 (adjournment), Section 3.13 (notice of adjournment) and Section 3.14 (board action by written consent without meeting), with such changes in the context of those bylaws as are necessary to substitute the committee and its members for the board of directors and its members; provided, however, that the time of regular meetings of committees may be determined either by resolution of the board of directors or by resolution of the committee, that special meetings of committees may also be called by resolution of the board of directors, and that notice of special meetings of committees shall also be given to all alternate members, who shall have the right to attend all meetings of the committee. The board of directors may adopt rules for the government of any committee not inconsistent with the provisions of these bylaws. 4.3 COMMITTEE MINUTES ----------------- Each committee shall keep regular minutes of its meetings and report the same to the board of directors when required. ARTICLE V OFFICERS -------- 5.1 OFFICERS -------- The Corporate Officers of the corporation shall be a president, a secretary and a chief financial officer. The corporation may also have, at the discretion of the board of directors, a chairman of the board, one or more vice presidents (however denominated), one or more assistant secretaries, a treasurer and one or more assistant treasurers, and such other officers as may be appointed in accordance with the provisions of Section 5.3 of these bylaws. Any number of offices may be held by the same person. In addition to the Corporate Officers of the Company described above, there may also be such Administrative Officers of the corporation as may be designated and appointed from time to time by the president of the corporation in accordance with the provisions of Section 5.12 of these bylaws. 5.2 ELECTION OF OFFICERS -------------------- The Corporate Officers of the corporation, except such officers as may be appointed in accordance with the provisions of Section 5.3 or Section 5.5 of these bylaws, shall be chosen by the board of directors, subject to the rights, if any, of an officer under any contract of employment, and shall hold their respective offices for such terms as the board of directors may from time to time determine. -12- 5.3 SUBORDINATE OFFICERS -------------------- The board of directors may appoint, or may empower the president to appoint, such other Corporate Officers as the business of the corporation may require, each of whom shall hold office for such period, have such power and authority, and perform such duties as are provided in these bylaws or as the board of directors may from time to time determine. The president may from time to time designate and appoint Administrative Officers of the corporation in accordance with the provisions of Section 5.12 of these bylaws. 5.4 REMOVAL AND RESIGNATION OF OFFICERS ----------------------------------- Subject to the rights, if any, of a Corporate Officer under any contract of employment, any Corporate Officer may be removed, either with or without cause, by the board of directors at any regular or special meeting of the board or, except in case of a Corporate Officer chosen by the board of directors, by any Corporate Officer upon whom such power of removal may be conferred by the board of directors. Any Corporate Officer may resign at any time by giving written notice to the corporation. Any resignation shall take effect at the date of the receipt of that notice or at any later time specified in that notice; and, unless otherwise specified in that notice, the acceptance of the resignation shall not be necessary to make it effective. Any resignation is without prejudice to the rights, if any, of the corporation under any contract to which the Corporate Officer is a party. Any Administrative Officer designated and appointed by the president may be removed, either with or without cause, at any time by the president. Any Administrative Officer may resign at any time by giving written notice to the president or to the secretary of the corporation. 5.5 VACANCIES IN OFFICES -------------------- A vacancy in any office because of death, resignation, removal, disqualification or any other cause shall be filled in the manner prescribed in these bylaws for regular appointments to that office. 5.6 CHAIRMAN OF THE BOARD --------------------- The chairman of the board, if such an officer be elected, shall, if present, preside at meetings of the board of directors and exercise such other powers and perform such other duties as may from time to time be assigned to him by the board of directors or as may be prescribed by these bylaws. If there is no president, then the chairman of the board shall also be the chief executive officer of the corporation and shall have the powers and duties prescribed in Section 5.7 of these bylaws. 5.7 PRESIDENT --------- Subject to such supervisory powers, if any, as may be given by the board of directors to the chairman of the board, if there be such an officer, the president shall be the chief executive officer of the -13- corporation and shall, subject to the control of the board of directors, have general supervision, direction and control of the business and the officers of the corporation. He or she shall preside at all meetings of the stockholders and, in the absence or nonexistence of a chairman of the board, at all meetings of the board of directors. He or she shall have the general powers and duties of management usually vested in the office of president of a corporation, and shall have such other powers and perform such other duties as may be prescribed by the board of directors or these bylaws. 5.8 VICE PRESIDENTS --------------- In the absence or disability of the president, and if there is no chairman of the board, the vice presidents, if any, in order of their rank as fixed by the board of directors or, if not ranked, a vice president designated by the board of directors, shall perform all the duties of the president and when so acting shall have all the powers of, and be subject to all the restrictions upon, the president. The vice presidents shall have such other powers and perform such other duties as from time to time may be prescribed for them respectively by the board of directors, these bylaws, the president or the chairman of the board. 5.9 SECRETARY --------- The secretary shall keep or cause to be kept, at the principal executive office of the corporation or such other place as the board of directors may direct, a book of minutes of all meetings and actions of the board of directors, committees of directors and stockholders. The minutes shall show the time and place of each meeting, whether regular or special (and, if special, how authorized and the notice given), the names of those present at directors' meetings or committee meetings, the number of shares present or represented at stockholders' meetings and the proceedings thereof. The secretary shall keep, or cause to be kept, at the principal executive office of the corporation or at the office of the corporation's transfer agent or registrar, as determined by resolution of the board of directors, a share register or a duplicate share register, showing the names of all stockholders and their addresses, the number and classes of shares held by each, the number and date of certificates evidencing such shares and the number and date of cancellation of every certificate surrendered for cancellation. The secretary shall give, or cause to be given, notice of all meetings of the stockholders and of the board of directors required to be given by law or by these bylaws. He or she shall keep the seal of the corporation, if one be adopted, in safe custody and shall have such other powers and perform such other duties as may be prescribed by the board of directors or by these bylaws. 5.10 CHIEF FINANCIAL OFFICER ----------------------- The chief financial officer shall keep and maintain, or cause to be kept and maintained, adequate and correct books and records of accounts of the properties and business transactions of the corporation, including accounts of its assets, liabilities, receipts, disbursements, gains, losses, capital, retained earnings and shares. The books of account shall at all reasonable times be open to inspection by any director for a purpose reasonably related to his position as a director. -14- The chief financial officer shall deposit all money and other valuables in the name and to the credit of the corporation with such depositaries as may be designated by the board of directors. He or she shall disburse the funds of the corporation as may be ordered by the board of directors, shall render to the president and directors, whenever they request it, an account of all of his or her transactions as chief financial officer and of the financial condition of the corporation, and shall have such other powers and perform such other duties as may be prescribed by the board of directors or these bylaws. 5.11 ASSISTANT SECRETARY ------------------- The assistant secretary, if any, or, if there is more than one, the assistant secretaries in the order determined by the board of directors (or if there be no such determination, then in the order of their election) shall, in the absence of the secretary or in the event of his or her inability or refusal to act, perform the duties and exercise the powers of the secretary and shall perform such other duties and have such other powers as the board of directors may from time to time prescribe. 5.12 ADMINISTRATIVE OFFICERS ----------------------- In addition to the Corporate Officers of the corporation as provided in Section 5.1 of these bylaws and such subordinate Corporate Officers as may be appointed in accordance with Section 5.3 of these bylaws, there may also be such Administrative Officers of the corporation as may be designated and appointed from time to time by the president of the corporation. Administrative Officers shall perform such duties and have such powers as from time to time may be determined by the president or the board of directors in order to assist the Corporate Officers in the furtherance of their duties. In the performance of such duties and the exercise of such powers, however, such Administrative Officers shall have limited authority to act on behalf of the corporation as the board of directors shall establish, including but not limited to limitations on the dollar amount and on the scope of agreements or commitments that may be made by such Administrative Officers on behalf of the corporation, which limitations may not be exceeded by such individuals or altered by the president without further approval by the board of directors. 5.13 AUTHORITY AND DUTIES OF OFFICERS -------------------------------- In addition to the foregoing powers, authority and duties, all officers of the corporation shall respectively have such authority and powers and perform such duties in the management of the business of the corporation as may be designated from time to time by the board of directors. -15- ARTICLE VI INDEMNIFICATION OF DIRECTORS, OFFICERS, EMPLOYEES ------------------------------------------------- AND OTHER AGENTS ---------------- 6.1 INDEMNIFICATION OF DIRECTORS AND OFFICERS ----------------------------------------- The corporation shall, to the maximum extent and in the manner permitted by the General Corporation Law of Delaware as the same now exists or may hereafter be amended, indemnify any person against expenses (including attorneys' fees), judgments, fines, and amounts paid in settlement actually and reasonably incurred in connection with any threatened, pending or completed action, suit, or proceeding in which such person was or is a party or is threatened to be made a party by reason of the fact that such person is or was a director or officer of the corporation. For purposes of this Section 6.1, a "director" or "officer" of the corporation shall mean any person (i) who is or was a director or officer of the corporation, (ii) who is or was serving at the request of the corporation as a director or officer of another corporation, partnership, joint venture, trust or other enterprise, or (iii) who was a director or officer of a corporation which was a predecessor corporation of the corporation or of another enterprise at the request of such predecessor corporation. The corporation shall be required to indemnify a director or officer in connection with an action, suit, or proceeding (or part thereof) initiated by such director or officer only if the initiation of such action, suit, or proceeding (or part thereof) by the director or officer was authorized by the Board of Directors of the corporation. The corporation shall pay the expenses (including attorney's fees) incurred by a director or officer of the corporation entitled to indemnification hereunder in defending any action, suit or proceeding referred to in this Section 6.1 in advance of its final disposition; provided, however, that payment of expenses incurred by a director or officer of the corporation in advance of the final disposition of such action, suit or proceeding shall be made only upon receipt of an undertaking by the director or officer to repay all amounts advanced if it should ultimately be determined that the director of officer is not entitled to be indemnified under this Section 6.1 or otherwise. The rights conferred on any person by this Article shall not be exclusive of any other rights which such person may have or hereafter acquire under any statute, provision of the corporation's Certificate of Incorporation, these bylaws, agreement, vote of the stockholders or disinterested directors or otherwise. Any repeal or modification of the foregoing provisions of this Article shall not adversely affect any right or protection hereunder of any person in respect of any act or omission occurring prior to the time of such repeal or modification. -16- 6.2 INDEMNIFICATION OF OTHERS ------------------------- The corporation shall have the power, to the maximum extent and in the manner permitted by the General Corporation Law of Delaware as the same now exists or may hereafter be amended, to indemnify any person (other than directors and officers) against expenses (including attorneys' fees), judgments, fines, and amounts paid in settlement actually and reasonably incurred in connection with any threatened, pending or completed action, suit, or proceeding, in which such person was or is a party or is threatened to be made a party by reason of the fact that such person is or was an employee or agent of the corporation. For purposes of this Section 6.2, an "employee" or "agent" of the corporation (other than a director or officer) shall mean any person (i) who is or was an employee or agent of the corporation, (ii) who is or was serving at the request of the corporation as an employee or agent of another corporation, partnership, joint venture, trust or other enterprise, or (iii) who was an employee or agent of a corporation which was a predecessor corporation of the corporation or of another enterprise at the request of such predecessor corporation. 6.3 INSURANCE --------- The corporation may purchase and maintain insurance on behalf of any person who is or was a director, officer, employee or agent of the corporation, or is or was serving at the request of the corporation as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise against any liability asserted against him or her and incurred by him or her in any such capacity, or arising out of his or her status as such, whether or not the corporation would have the power to indemnify him or her against such liability under the provisions of the General Corporation Law of Delaware. ARTICLE VII RECORDS AND REPORTS ------------------- 7.1 MAINTENANCE AND INSPECTION OF RECORDS ------------------------------------- The corporation shall, either at its principal executive office or at such place or places as designated by the board of directors, keep a record of its stockholders listing their names and addresses and the number and class of shares held by each stockholder, a copy of these bylaws as amended to date, accounting books and other records of its business and properties. Any stockholder of record, in person or by attorney or other agent, shall, upon written demand under oath stating the purpose thereof, have the right during the usual hours for business to inspect for any proper purpose the corporation's stock ledger, a list of its stockholders, and its other books and records and to make copies or extracts therefrom. A proper purpose shall mean a purpose reasonably related to such person's interest as a stockholder. In every instance where an attorney or other agent is the person who seeks the right to inspection, the demand under oath shall be accompanied by a power of attorney or such other writing that authorizes the attorney or other agent to so act on behalf of the -17- stockholder. The demand under oath shall be directed to the corporation at its registered office in Delaware or at its principal place of business. 7.2 INSPECTION BY DIRECTORS ----------------------- Any director shall have the right to examine (and to make copies of) the corporation's stock ledger, a list of its stockholders and its other books and records for a purpose reasonably related to his or her position as a director. 7.3 ANNUAL STATEMENT TO STOCKHOLDERS -------------------------------- The board of directors shall present at each annual meeting, and at any special meeting of the stockholders when called for by vote of the stockholders, a full and clear statement of the business and condition of the corporation. 7.4 REPRESENTATION OF SHARES OF OTHER CORPORATIONS ---------------------------------------------- The chairman of the board, if any, the president, any vice president, the chief financial officer, the secretary or any assistant secretary of this corporation, or any other person authorized by the board of directors or the president or a vice president, is authorized to vote, represent and exercise on behalf of this corporation all rights incident to any and all shares of the stock of any other corporation or corporations standing in the name of this corporation. The authority herein granted may be exercised either by such person directly or by any other person authorized to do so by proxy or power of attorney duly executed by such person having the authority. 7.5 CERTIFICATION AND INSPECTION OF BYLAWS -------------------------------------- The original or a copy of these bylaws, as amended or otherwise altered to date, certified by the secretary, shall be kept at the corporation's principal executive office and shall be open to inspection by the stockholders of the corporation, at all reasonable times during office hours. ARTICLE VIII GENERAL MATTERS --------------- 8.1 RECORD DATE FOR PURPOSES OTHER THAN NOTICE AND VOTING ----------------------------------------------------- For purposes of determining the stockholders entitled to receive payment of any dividend or other distribution or allotment of any rights or the stockholders entitled to exercise any rights in respect of any change, conversion or exchange of stock, or for the purpose of any other lawful action, the board of directors may fix, in advance, a record date, which shall not precede the date upon which the resolution fixing the record date is adopted and which shall not be more than sixty (60) days before any such action. In that case, only stockholders of record at the close of business on the date so fixed are entitled to -18- receive the dividend, distribution or allotment of rights, or to exercise such rights, as the case may be, notwithstanding any transfer of any shares on the books of the corporation after the record date so fixed, except as otherwise provided by law. If the board of directors does not so fix a record date, then the record date for determining stockholders for any such purpose shall be at the close of business on the day on which the board of directors adopts the applicable resolution. 8.2 CHECKS; DRAFTS; EVIDENCES OF INDEBTEDNESS ----------------------------------------- From time to time, the board of directors shall determine by resolution which person or persons may sign or endorse all checks, drafts, other orders for payment of money, notes or other evidences of indebtedness that are issued in the name of or payable to the corporation, and only the persons so authorized shall sign or endorse those instruments. 8.3 CORPORATE CONTRACTS AND INSTRUMENTS: HOW EXECUTED -------------------------------------------------- The board of directors, except as otherwise provided in these bylaws, may authorize and empower any officer or officers, or agent or agents, to enter into any contract or execute any instrument in the name of and on behalf of the corporation; such power and authority may be general or confined to specific instances. Unless so authorized or ratified by the board of directors or within the agency power of an officer, no officer, agent or employee shall have any power or authority to bind the corporation by any contract or engagement or to pledge its credit or to render it liable for any purpose or for any amount. 8.4 STOCK CERTIFICATES; TRANSFER; PARTLY PAID SHARES ------------------------------------------------ The shares of the corporation shall be represented by certificates, provided that the board of directors of the corporation may provide by resolution or resolutions that some or all of any or all classes or series of its stock shall be uncertificated shares. Any such resolution shall not apply to shares represented by a certificate until such certificate is surrendered to the corporation. Notwithstanding the adoption of such a resolution by the board of directors, every holder of stock represented by certificates and, upon request, every holder of uncertificated shares, shall be entitled to have a certificate signed by, or in the name of the corporation by, the chairman or vice-chairman of the board of directors, or the president or vice-president, and by the treasurer or an assistant treasurer, or the secretary or an assistant secretary of such corporation representing the number of shares registered in certificate form. Any or all of the signatures on the certificate may be a facsimile. In case any officer, transfer agent or registrar who has signed or whose facsimile signature has been placed upon a certificate has ceased to be such officer, transfer agent or registrar before such certificate is issued, it may be issued by the corporation with the same effect as if he or she were such officer, transfer agent or registrar at the date of issue. Certificates for shares shall be of such form and device as the board of directors may designate and shall state the name of the record holder of the shares represented thereby; its number; date of issuance; the number of shares for which it is issued; a summary statement or reference to the powers, -19- designations, preferences or other special rights of such stock and the qualifications, limitations or restrictions of such preferences and/or rights, if any; a statement or summary of liens, if any; a conspicuous notice of restrictions upon transfer or registration of transfer, if any; a statement as to any applicable voting trust agreement; if the shares be assessable, or, if assessments are collectible by personal action, a plain statement of such facts. Upon surrender to the secretary or transfer agent of the corporation of a certificate for shares duly endorsed or accompanied by proper evidence of succession, assignment or authority to transfer, it shall be the duty of the corporation to issue a new certificate to the person entitled thereto, cancel the old certificate and record the transaction upon its books. The corporation may issue the whole or any part of its shares as partly paid and subject to call for the remainder of the consideration to be paid therefor. Upon the face or back of each stock certificate issued to represent any such partly paid shares, or upon the books and records of the corporation in the case of uncertificated partly paid shares, the total amount of the consideration to be paid therefor and the amount paid thereon shall be stated. Upon the declaration of any dividend on fully paid shares, the corporation shall declare a dividend upon partly paid shares of the same class, but only upon the basis of the percentage of the consideration actually paid thereon. 8.5 SPECIAL DESIGNATION ON CERTIFICATES ----------------------------------- If the corporation is authorized to issue more than one class of stock or more than one series of any class, then the powers, the designations, the preferences and the relative, participating, optional or other special rights of each class of stock or series thereof and the qualifications, limitations or restrictions of such preferences and/or rights shall be set forth in full or summarized on the face or back of the certificate that the corporation shall issue to represent such class or series of stock; provided, however, that, except as otherwise provided in Section 202 of the General Corporation Law of Delaware, in lieu of the foregoing requirements there may be set forth on the face or back of the certificate that the corporation shall issue to represent such class or series of stock a statement that the corporation will furnish without charge to each stockholder who so requests the powers, the designations, the preferences and the relative, participating, optional or other special rights of each class of stock or series thereof and the qualifications, limitations or restrictions of such preferences and/or rights. 8.6 LOST CERTIFICATES ----------------- Except as provided in this Section 8.6, no new certificates for shares shall be issued to replace a previously issued certificate unless the latter is surrendered to the corporation and cancelled at the same time. The board of directors may, in case any share certificate or certificate for any other security is lost, stolen or destroyed, authorize the issuance of replacement certificates on such terms and conditions as the board may require; the board may require indemnification of the corporation secured by a bond or other adequate security sufficient to protect the corporation against any claim that may be made against it, including any expense or liability, on account of the alleged loss, theft or destruction of the certificate or the issuance of the replacement certificate. -20- 8.7 TRANSFER AGENTS AND REGISTRARS ------------------------------ The board of directors may appoint one or more transfer agents or transfer clerks, and one or more registrars, each of which shall be an incorporated bank or trust company -- either domestic or foreign, who shall be appointed at such times and places as the requirements of the corporation may necessitate and the board of directors may designate. 8.8 CONSTRUCTION; DEFINITIONS ------------------------- Unless the context requires otherwise, the general provisions, rules of construction and definitions in the General Corporation Law of Delaware shall govern the construction of these bylaws. Without limiting the generality of this provision, as used in these bylaws, the singular number includes the plural, the plural number includes the singular, and the term "person" includes both an entity and a natural person. ARTICLE IX AMENDMENTS ---------- The original or other bylaws of the corporation may be adopted, amended or repealed by the stockholders entitled to vote or by the board of directors of the corporation. The fact that such power has been so conferred upon the directors shall not divest the stockholders of the power, nor limit their power to adopt, amend or repeal bylaws. Whenever an amendment or new bylaw is adopted, it shall be copied in the book of bylaws with the original bylaws, in the appropriate place. If any bylaw is repealed, the fact of repeal with the date of the meeting at which the repeal was enacted or the filing of the operative written consent(s) shall be stated in said book. -21- CERTIFICATE OF ADOPTION OF BYLAWS OF APPLIED IMAGING CORP. ADOPTION BY INCORPORATOR ------------------------ The undersigned person appointed in the Certificate of Incorporation to act as the Incorporator of Applied Imaging Corp. hereby adopts the foregoing bylaws, comprising twenty-one (21) pages, as the Bylaws of the corporation. Effective as of August 30, 1996. /s/ Jason M. Brady --------------------------------- Jason M. Brady Incorporator Certificate by Secretary of Adoption by Incorporator ---------------------------------------------------- The undersigned hereby certifies that he is the duly elected, qualified, and acting Secretary of Applied Imaging Corp. and that the foregoing Bylaws, comprising twenty-one (21) pages, were adopted as the Bylaws of the corporation effective as of August 30, 1996, by the person appointed in the Certificate of Incorporation to act as the Incorporator of the corporation. IN WITNESS WHEREOF, the undersigned has hereunto set his hand and affixed the corporate seal this 30th day of August 1996. /s/ Neil E. Woodruff -------------------------------- Neil E. Woodruff Secretary -22-
EX-10.21 3 LICENSE AGREEMENT Exh. 10.21 PATENT LICENSE AND MATERIAL TRANSFER AGREEMENT This Agreement is made by and between Cambridge University Technical Services Ltd at The Old Schools, Trinity Lane, Cambridge, Great Britain CB2 TS, hereinafter referred to as "University", and Applied Imaging Corporation, a Delaware corporation, having its office and principal place of business at 2380 Walsh Avenue, Building B, Santa Clara, California 95051 United States of America, hereinafter referred to as "Licensee". Witnesseth: Whereas, University owns certain Patent Rights related to the Licensed Subject Matter listed in Attachment A; Whereas, University also owns Technology and Tangible Technical Materials related to the Licensed Subject Matter, namely Assays to Detect and Analyze Chromosomal Aberrations in various species using labeled DNA from a related species as a set of probes, covered by British Patent Application No. 9704054.7. Whereas, University wishes to have the technical information covered by the Patent Rights and/or included in the Technology and Tangible Technical Materials developed and used; Whereas, Licensee wishes to obtain an exclusive license under such Patent Rights, Technology, and Tangible Technical Materials to practice such invention; and Whereas, Licensee wishes University to produce and supply Tangible Technical Materials to Licensee. [ * ] = 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. Page 2 of 22 Now, therefore, in consideration of the mutual covenants and premises herein contained, the parties hereto agree as follows: 1. EFFECTIVE DATE This Agreement shall be effective as of the date of execution (Effective Date). 2. DEFINITIONS As used in this Agreement, the following terms shall have the meanings indicated. 2.1 Licensed Subject Matter shall mean Licensed Patent Product, Patent Rights, Technology, and Tangible Technical Materials in the field of in vitro diagnostic assays, using labeled nucleic acid probes. 2.2 Patent Rights shall mean those worldwide prospective or existing patent applications and/or worldwide prospective or existing letters patents, including any division, continuation, continuation-in-part, provisional, reissue, or extension thereof, or substitute therefor of the current patent applications listed in Attachment A, which are owned, assigned, or by right of contact or law assignable to University. Attachment A shall be amended from time to time to include any additional patents or patent applications not previously listed. 2.3 Technology shall mean, any existing or future invention, discovery, know-how, process, procedure, method, protocol, formula, technique, software, design, drawing, data or other valuable technical information of University's relating to Patent Rights and Tangible Technical Materials in the field of in vitro diagnostic assays, using labeled nucleic acid probes. Page 3 of 22 2.4 Tangible Technical Materials shall mean University's existing or future labeled DNA probes from one vertebrate species which are used to detect chromosomal aberrations in another vertebrate species as described in the Patent Rights. 2.5 Affiliate shall mean, with respect to either party, any corporation, university, or other business or legal entity either directly or indirectly controlling, controlled by, or under common control with such party. Control shall mean possession of the power to direct or cause the direction of the management and policies of any entity, whether through ownership of voting stock, by contract, or otherwise. In the case of a corporation, control shall mean the direct or indirect ownership of equal to or more than fifty percent (50%) of the outstanding voting stock. 2.6 Licensed Patent Product shall mean all current and future products the manufacture, use, importation, offer to sell, or sale of which is covered by one or more claims of the Patent Rights, so long as the related patent claims have not been held invalid or unenforceable by a court or other body of competent jurisdiction from which no appeal has been or may be taken. 2.7 Net Sales shall mean the actual gross invoice price of Licensed Patent Product sold by Licensee, its Affiliates and sublicensees to third party customers less, to the extent included therein, the total of (i) ordinary and customary trade discounts; (ii) sales and excise taxes, and other similar taxes, such as Value Added Taxes (VAT), customs duty and compulsory payments to governmental authorities actually paid or deducted and related to the sale; and (iii) credits given to customers for rejects or returns of License Patent Product. 2.8 For Licensed Patent Products sold in combination with other products, "Combination Product", Net Sales of the License Patent Product shall be calculated by multiplying Net Sales of the Combination Product by the fraction A/(B) wherein A is the sales price of the Licensed Patent Product when sold separately and B is the total sales price of the Combination Product. If the Licensed Patent Product is not sold separately, then cost of Page 4 of 22 production for each component shall be substituted for sales price in the above formula. 2.9 One "test" is sufficient to do one (1) in situ hybridization on a 22 mm x 22 mm cover slip. 3. GRANT 3.1 University hereby grants to Licensee and its Affiliates a worldwide exclusive license under its Patent Rights, Technology, and Tangible Technical Materials to make, have made, import, use, offer to sell, or sell Licensed Subject Matter during the Term of this Agreement. University shall transfer Technology and Tangible Technical Materials to Licensee upon the Effective Date of this Agreement. 3.2 Licensee shall have the right to grant sublicenses consistent with this Agreement, provided that Licensee shall be responsible for the operations of its sublicensees relevant to this Agreement as if such operations were carried out by Licensee, including payment of royalties, whether or not paid to Licensee by the sublicensee. 3.3 Licensee shall have the Right to enter into crosslicense agreements with third parties in which Licensee grants the third party a sublicense consistent with this agreement. 3.4 University and the University of Cambridge reserve the right to practice and use Patent Rights, Technology, and/or other Tangible Technical Materials for their own non-commercial research purposes, but for no other use. Page 5 of 22 4. COMPENSATION 4.1 Within thirty (30) days of the execution of this Agreement, Licensee shall pay University [ * ] of which having already been paid by Licensee to University. 4.2 Licensee shall pay a royalty of [ * ] of Net Sales of Licensed Patent Products sold in any country in which a patent has been issued or granted within the Patent Rights, wherein a claim or claims of the issued patent covers the manufacture, use, import, or sale of Licensed Patent Products. 4.3 Licensee shall pay a royalty of [ * ] of Net Sales of Licensed Patent Products sold in any country in which a patent application is pending, wherein a pending claim or claims of the application covers the manufacture, use, import, or sale of Licensed Products. 4.4 Licensee shall pay a minimum annual royalty of [ * ]. The minimum annual royalty shall be paid in annual installments beginning on January 1, 1998, and payable thereafter on each anniversary thereof during the term of this Agreement. This minimum annual royalty shall be non-refundable but shall be creditable against earned royalties in any calendar year until the entire credit is exhausted. 4.5 Licensee shall pay a royalty of [ * ] of Net Sales of Licensed Patent Products sold in any country wherein no patent has issued or is pending until a competitive product is sold by a third party. Licensee shall notify University of the sale of the third-party competitive product and all royalty payments due in that country under this Section 4.5 shall immediately cease. 4.6 No royalties shall be paid on the sale of a Licensed Patent Product in a country after the Patent Rights covering such Licensed Patent Product have expired. Upon Licensee's [ * ] = 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. Page 6 of 22 final royalty payment due in a country, Licensee shall be deemed to have a full paid-up irrevocable license. 4.7 No royalties shall be due upon the sales of Licensed Patent Products to and between Licensee and/or it Affiliates, or between Licensee, its Affiliates, and/or sublicensees. 4.8 If more than one royalty or royalty rate should be applicable to any transaction, only a single royalty shall be due and that royalty shall be computed at the highest applicable royalty rate. Only a single royalty shall be paid on sales of Licensed Patent Products no matter how many patent claims or Patent Rights cover such Licensed Patent Products. 4.9 Licensee shall pay to University the royalties set forth in this Agreement within sixty (60) days after the end of each calendar quarter, along with a report identifying the Licensed Patent Products, the Net Sales, and the computation of the royalties payable to University. If no royalties are due, it shall be so reported. 4.10 Royalties due on Net Sales of Licensed Patent Products shall be in US Dollars, and, unless otherwise agreed in writing, shall be made by wire transfer to such United Kingdom bank as University shall designate in writing. The payment shall be made without set-off, and free and clear of, and without any deduction or withholding for, or on account of, any taxes, duties, levies, imposts, fees or charges. Royalties due on Net Sales of Licensed Patent Products made in currency other than US Dollars shall first be calculated in the foreign currency and then converted to US Dollars on the basis of the rate of exchange in effect on the last business day of the quarterly period for which royalties are due as published in The Wall Street Journal. if no rate is published therein, the conversion shall be based upon that prevailing at Chase Manhattan Bank. If restrictions on the transfer of currency exist in any country such as to prevent Licensee from making payments in US Dollars, Licensee shall make the royalty payment due upon Net Sales in such country in local currency and shall deposit such payments in a local bank or other depository designated by University in writing. Page 7 of 22 4.11 During the Term of this Agreement and for three (3) years thereafter, Licensee shall keep complete and accurate records of its and its sublicensee's Net Sales of Licensed Patent Products under the license granted in this Agreement in sufficient detail to enable the royalties to be determined. Upon thirty (30)-days' written notice, Licensee shall permit University, or its representatives, at University's expense, to examine Licensee's books, ledgers, and records covering Net Sales of Licensed Patent Products during regular business hours for the purpose of verifying, and to the extent necessary to verify, any report required under this Agreement. Such examination shall be limited to a period of time no more than three (3) fiscal years immediately preceding the request for examination. Information received by the University or its representatives shall be considered Licensee's Confidential Information and subject to the Confidentiality Section below. 4.12 If a third party obtains, by order, decree or grant from a governmental authority in any country, a compulsory license authorizing such third party to make, have made, use, import, or sell Licensed Subject Matter, Licensee's obligations to pay royalties with respect to Net Sales of Licensed Patent Products in that country shall be equal to and no more than the royalty rate payable to Licensee or Licensor by said third party, during the effective period of such compulsory license. 5. CONFIDENTIALITY 5.1 Except as is necessary in Licensee's discretion for the development and/or commercialization of the Licensed Subject Matter, Licensee shall not disclose information regarding the format of any Tangible Technical Materials nor convey them nor disclose Technology to third parties without the express written consent of University during the Term of this Agreement and for a period of three (3) years thereafter, except to the extent that such Tangible Technical Materials or Technology: Page 8 of 22 (a) is part of the public domain at the time of its disclosure to Licensee or later becomes part of the public domain through no fault of Licensee; (b) was in the possession of Licensee prior to receipt from University; (c) is received from a third party having no obligations of confidentiality to University; or (d) is necessary to enforce, or resolve a dispute under, this Agreement; or is advisable or necessary to comply with any applicable local, state, federal, or international regulation or law. 5.2 University shall not disclose information concerning Licensee's business or products relating to the Licensed Subject Matter (Licensee's Confidential Information) during the Term of this Agreement and for a period of three (3) years thereafter, except to the extent that such Licensee's Confidential Information: (a) is part of the public domain at the time of its disclosure to University or later becomes part of the public domain through no fault of University; (b) was in the possession of University prior to receipt from Licensee; (c) is received from a third party having no obligations of confidentiality to Licensee; or (d) is necessary to enforce, or resolve a dispute under, this Agreement; or is advisable or necessary to comply with any applicable local, state, federal, or international regulation or law. 5.3 These confidentiality provisions shall survive termination or expiration of this Agreement. Page 9 of 22 6. PRODUCT DEVELOPMENT 6.1 Licensee shall be free to establish any technical, pre-clinical, and/or clinical program, at its expense, for the purposes of developing and/or marketing Licensed Subject Matter. Licensee shall own all resulting data and all rights arising therefrom. 6.2 University shall supply such assistance, consultation, documents or information within its possession relating to the Licensed Subject Matter upon written request of Licensee, and at no cost to Licensee. 7. DILIGENCE 7.1 Licensee agrees to use all reasonable efforts and diligence to proceed with the development, manufacture, and/or sale of Licensed Patent Products. 8. PATENTS 8.1 Licensee shall take all reasonable and necessary steps, and pay all necessary expenses, to obtain and maintain worldwide patent protection for Patent Rights. The filing, prosecution, and maintenance of Patent Rights shall be the primary responsibility of Licensee; provided however, that University shall have the right to review and comment on the prosecution patent counsel, and strategy concerning Patent Rights, which review and comment Licensee shall consider. The parties shall discuss the country list for the filing of any additional patent applications within Patent Rights. 8.2 Licensee shall not finally abandon any Patent Rights without the written consent of University, which consent shall not be unreasonably withheld. University shall have the right, Page 10 of 22 but not the obligation, to assume prosecution of any Patent Right which Licensee intends to abandon or fail to maintain. 8.3 University and Licensee agree, at Licensee's cost, to cooperate fully with the other in the preparation and prosecution of Patent Rights. 8.4 Licensee agrees to mark the Licensed Patent Products with the proper legend concerning patent coverage, in accordance with the laws of each respective country. 9. SUPPLY OF TANGIBLE TECHNICAL MATERIALS 9.1 University shall make best efforts to procure the supply to Licensee [ * ] initial prototype tests containing Tangible Technical Materials for Licensee's evaluation. Licensee shall pay University [ * ] for each prototype test supplied and no additional royalty or payment shall be owed by Licensee for these prototype tests. University shall make best efforts to ship these prototype tests within thirty (30) days of the Effective Date of this Agreement and Licensee shall have thirty (30) days in which to accept or reject the prototype tests. If Licensee rejects any or all of the prototype tests, University agrees to make best efforts to replace them within thirty (30) days. For those prototype tests accepted by Licensee, Licensee shall pay the designated amount per prototype test within thirty (30) days. 9.2 The prototype tests shall be evaluated by Licensee at its sole discretion and based upon acceptance criteria set solely by Licensee. [ * ] = 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. Page 11 of 22 9.3 Licensee shall bear full responsibility to obtain and pay for all licenses and/or clearances related to the manufacture, use, export, and/or sale of the prototype tests, including the Tangible Technical Materials and other prototype test components. 9.4 Full title to the prototype tests and risk of loss shall pass to Licensee at the point of receipt (FOB receiving point). Licensee shall have no further obligation to University except as noted above. University shall be responsible for any loss, or damage to, the prototype tests which occurs in transit. Also, University shall pay all freight and handling charges, as well as any other charges or non-VAT taxes relating to the supply and shipment of the prototype tests. 9.5 University shall make best efforts to fully and adequately inform Licensee, in writing, prior to the shipment of any and all safety, health, and environmental hazards associated with the manufacture, receipt, use, and/or storage of the prototype tests. University also shall make best efforts to fully and adequately inform Licensee, in writing, of the prototype test's contents as well as the proper storage, handling, and use procedures for the prototype tests and shall render reasonable technical assistance as requested by Licensee, at no cost to Licensee. 9.6 For commercial tests subsequently supplied by the University to Licensee, at Licensee's written request, Licensee shall pay [ * ] for each commercial test supplied in addition to the royalty owed by Licensee for these commercial tests. It is understood that Licensee shall not be obligated to order any commercial tests. Licensee reserves the right to obtain probes from another supplier; however, University shall be Licensee's exclusive source of sorted chromosomes unless it is unable to supply the chromosomes [ * ] of when Licensee places the order for such chromosomes. In the event University is unable to supply the chromosomes [ * ], Licensee reserves the right to obtain the chromosomes from another supplier. The price for the sorted chromosomes shall be negotiated in good faith between the parties, but it is the intent of the parties that such price be a commercially-competitive price. [ * ] = 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. Page 12 of 22 9.7 University shall make best efforts to ensure that the Tangible Materials are produced in circumstances where that degree of skill, diligence, prudence, documentation, and foresight, which would be reasonably expected from a skilled or experienced person engaged in the same type of undertaking under the same or similar circumstances, are exercised. After providing reasonable notice, Licensee shall have the right, but not the obligation to, inspect University's quality control procedures and to coordinate with University in setting such procedures. 10. PATENT INFRINGEMENT 10.1 If any patent infringement action is brought by a third party against Licensee, its Affiliates, and/or its sublicensees because of actual or anticipated manufacture, use, offer to sell, or sale of the Licensed Subject Matter, Licensee shall promptly notify University and send University copies of all relevant court documents. Licensee, at its own expense, shall promptly defend against such infringement unless the third party infringement action is due to the actual or anticipated manufacture, use, import, or sale of Technology and/ or Tangible Technical Materials by the University; in which case, University, at its own expense, shall promptly defend against such infringement action, once notified by Licensee. Licensee shall cooperate with University in the litigation, at University's expense. University cannot settle the patent infringement action without the express written consent of Licensee, which consent shall not be unreasonably withheld. Any recovery shall be received by University, unless Licensee defends such infringement. In all other cases, Licensee shall have the right to settle and compromise the patent infringement action, including the right to cross-license, and Licensee shall receive all recoveries. However, Licensee cannot settle the patent infringement action without the express written consent of University, which consent shall not be unreasonably withheld. 10.2 If University, when obligated to defend as stated above, fails to defend such infringement action after being notified by Licensee within ninety (90) days, Licensee shall have the right, but not the obligation, to defend the infringement action in its name or in the name of Page 13 of 22 University as it deems necessary or appropriate, at Licensee's expense. Alternatively, if University fails to institute such infringement action, Licensee may consider this failure a breach of a material obligation of this Agreement and may terminate. If Licensee does undertake such a defense, University shall cooperate with Licensee in the litigation, at Licensee's expense. Any reasonable costs and expenses incurred by Licensee, including settlement costs, damages assessed against Licensee and reasonable outside attorney fees, shall be offset against royalty payments to University. Licensee shall have the right to settle the infringement action, including the right to enter into a cross license with the third party. Licensee shall notify University of its intent to settle in advance and Licensee shall consider all reasonable requests of the University related to the settlement. Licensee also shall receive all recoveries. Licensee shall also have the right to suspend royalty payments to University only in the country in which the litigation occurs during the pendency of the infringement suit. In the event judgment is rendered in favor of Licensee as to the non-infringement and/or invalidity of the third party patent, Licensee shall pay royalties for the suspended period within ninety (90) days of the judgment. 10.3 If Licensee is required in a country by final court order from which no appeal can be taken, to make changes in the Licensed Subject Matter or to obtain and pay a royalty under a license to a third party under any patent in order to make, have made, use or sell the Licensed Subject Matter in that country, Licensee's obligations in the country to pay royalties to University shall be reduced by the amount of the cost to Licensee for the changes and/or additional royalties payable to the third party. However, in no event will the royalty due to University be reduced below [ * ]. 10.4 If, during the Term of this Agreement, either party becomes aware of any third party infringement or threatened infringement of any Patent Rights, the party having such knowledge shall promptly notify the other party. Licensee shall the obligation to bring suit in its name, or in the name of University, if necessary, at Licensee's own expense, to restrain such infringement and to recover profits and damages. University agrees to being joined as a party plaintiff and to cooperation in the litigation as is reasonably necessary, at Licensee's expense. [ * ] = 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. Page 14 of 22 Licensee shall have the right to settle such action with University's prior written consent, which shall not be unreasonably withheld. Licensee shall receive all recoveries, unless University institutes the action as provided below. However, Licensee shall have the right to suspend royalty payments to University only in the country in which the litigation occurs during the pendency of the infringement suit. In the event judgment is rendered in favor of University and Licensee as to infringement and/or validity of Patent Rights, Licensee shall pay royalties for the suspended period within ninety (90) days of the judgment. 10.5 If Licensee fails to institute such infringement action within ninety (90) days of notification, University shall have the right, but not the obligation, to take action in its own name or in the name of Licensee as it deems necessary or appropriate, at University's expense. Licensee shall cooperate with University as is reasonably necessary in any such action brought by University. If University brings legal action, University shall have the right to settle such action with Licensee's prior written consent, which shall not be unreasonably withheld, and University shall receive all recoveries. In the event a court of competent jurisdiction determines that one or more claims of Patent Rights are invalid or unenforceable, no further royalty payments shall be due University by Licensee for the affected Licensed Patent Products, unless the affected Licensed Patent Products are still encompassed by a valid claim or claims of Patent Rights. 11. WARRANTIES 11.1 University represents and warrants, subject to the statement below, that it is the owner of the entire right, title and interest in and to Licensed Subject Matter, all of which is and shall be unencumbered by any liens, security interests, or other rights or claims of any third party, and no other person or entity has or shall have any claim of ownership. However, Licensee acknowledges that the University has received a written assignment from the inventors of the Patent Rights in which the inventors assigned their rights to the best of their knowledge Page 15 of 22 and Licensee acknowledges that the University has title through this assignment. In the event the inventors have breached their assignment obligation, University shall not be held in breach of this Section 11.1. 11.2 University also represents and warrants that it has sole responsibility to render appropriate payments to the inventors of the Patent Rights and the inventors' sources of funding , and to resolve disputes between it, the inventors of the Patent Rights and/or the inventors' sources of funding, concerning the allocation of the payments made by Licensee to University under this Agreement. 11.3 University represents and warrants that has the right to grant licenses under such Licensed Subject Matter, and that it has not granted licenses thereunder to any other person or entity. 11.4 University represents and warrants that to the best of its knowledge making, having made, using, selling, offering for sale, or importing the Licensed Subject Matter do not infringe any patent, trademark, or any other rights of any third party. 11.5 University represents and warrants that this Agreement has been duly executed and delivered, and is a legal, valid, and binding obligation enforceable against University in accordance with its terms. 11.6 University represents and warrants that it knows of no fact which does or could materially adversely affect the rights granted to Licensee under this Agreement. 11.7 University represents and warrants that the execution, delivery, and performance of this Agreement do not conflict with, violate, or breach any agreement to which University is a party, or University's charter or bylaws. Page 16 of 22 11.8 Except as expressly set forth in this Agreement, UNIVERSITY MAKES NO REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED. THERE ARE NO EXPRESS OR IMPLIED WARRANTIES OF MERCHANTIBILITY, QUALITY, OR FITNESS FOR A PARTICULAR PURPOSE. 11.9 Licensee represents and warrants that it is a corporation duly organized, existing, and in good standing under the laws of the State of Delaware, United States of America, with full right, power, and authority to enter into and perform this Agreement and to grant all of the rights, powers, and authorities granted herein. 11.10 Licensee represents and warrants that this Agreement has been duly executed and delivered, and is a legal, valid, and binding obligation enforceable against Licensee in accordance with its terms. 11.11 Licensee represents and warrants that the execution, delivery, and performance of this Agreement do not conflict with, violate, or breach any agreement to which Licensee is a party, or Licensee's articles of incorporation or bylaws. 12. INDEMNIFICATION 12.1 University shall be responsible for, and shall defend, indemnify and hold Licensee, its managers, directors, officers, employees, and agents (Licensee Indemnified Parties) harmless against any and all liability, loss, damage, claim or expense, including attorney's fees (Licensee Indemnified Losses) arising out of or in connection with this Agreement, including Licensee Indemnified Losses related to any third party infringement action due to the actual or anticipated manufacture, use, import, or sale of Technology or Tangible Technical Materials; including Licensee Indemnified Losses related to the negligence or willful misconduct of University; or including Licensee Indemnified Losses relating to any breach or default of an obligation, Page 17 of 22 representation, or warranty provided in this Agreement; provided, that Licensee shall give University prompt notice of any such claim or lawsuit. The indemnification rights of Licensee contained herein are in addition to all other rights Licensee may have at law, in equity, or otherwise. Any claims brought against University under this Section 12.1 shall be brought in an English court. 12.2 Licensee shall be responsible for, and shall defend, indemnify and hold University, its managers, directors, officers, employees, and agents (University Indemnified Parties) harmless against any and all liability, loss, damage, claim or expense, including attorney's fees (University Indemnified Losses) arising out of or in connection with this Agreement, including University Indemnified Losses related to the negligence or willful misconduct of Licensee; or including University Indemnified Losses relating to a breach or default by Licensee or sublicensee of an obligation, representation, or warranty provided in this Agreement; provided, however, that University shall give Licensee prompt notice of any such claim or lawsuit. The indemnification rights of University contained herein are in addition to all other rights which University may have at law, in equity, or otherwise. 12.3 The indemnification rights of Licensee and University shall survive termination or expiration of this Agreement. 13. TERM AND TERMINATION 13.1 This Agreement shall be effective as of the date of execution and its Term shall continue in full force and effect until the expiration of the last to expire Patent Rights, or ten (10) years, whichever is later. The provisions of Sections 5, 10, 11, 12, and 13 hereof shall survive the expiration or termination of this Agreement, except as otherwise provided herein. 13.2 If either party breaches or defaults in the performance or observance of any of the Page 18 of 22 material provisions of this Agreement, and such breach or default is not cured within ninety (90) days after the giving of notice by the other party specifying the breach or default, the non-defaulting party shall have the right to terminate this Agreement, effective upon the expiration of the ninety (90)-days, without further notice to the breaching or defaulting party. If termination is by Licensee because of University's breach or default, the rights and licenses granted by University to Licensee shall be deemed to be fully paid-up, exclusive, worldwide, and irrevocable. 13.3 Licensee may terminate this Agreement, in its entirety, at any time upon ninety (90)-days' written notice to University. Licensee may terminate this Agreement, in part, as to any specific Licensed Patent Product or any specific Patent Right, with immediate effect, upon written notice to University. 13.4 Except as otherwise provided in this Agreement, upon termination of this Agreement, all rights and licenses shall terminate and revert to University and Licensee shall not thereafter make, use, or sell any Licensed Subject Matter. 13.5 Termination of this Agreement in whole or in part for any reason shall not relieve University or Licensee of their respective continuing obligations under this Agreement. Termination of this Agreement for any reason shall be without prejudice to and shall not affect the right of either party to recover any and all damages to which it may be entitled, or exercise any other remedies which it may otherwise have. 13.6 Licensee may, after the effective date of any termination, sell all Licensed Patent Products in its inventory at the date of termination, provided that Licensee pays earned royalties thereon. 14. MISCELLANEOUS Page 19 of 22 14.1 This Agreement sets forth the entire agreement and understanding between the parties and supersedes all previous agreements, promises, representations, understandings, and negotiations, whether written or oral, between the parties with respect to the subject matter herein. None of the terms of this Agreement shall be amended or modified except in writing. 14.2 Neither party shall assign any right or obligation hereunder without the written consent of the other party, except if such assignment arises under a transaction in which the assigning party is selling its entire business or a line of business to which this Agreement relates, or the assigning party is being acquired or merged with a third party. This Agreement shall be binding upon, and inure to the benefit of, the parties' respective successors and assigns. 14.3 Either party may terminate this Agreement if, at any time, the other party shall file in any court or agency pursuant to any statute or any individual state or country, a petition in bankruptcy, insolvency, or for reorganization or for any agreement among creditors or for the appointment of a receiver or trustee of the party or of its assets, or if the other party proposes a written agreement of composition or extension of its debts, or if the other party is served with an involuntary petition against it filed in any insolvency proceeding, and such petition is not dismissed within ninety (90) days after the filing thereof, or if the other party shall propose or be a party to any dissolution or liquidation or if the other party makes an assignment for the benefit of creditors. 14.4 In the event any one or more of the provisions of this Agreement should for any reason be held by any court or authority having jurisdiction over this Agreement, or any of the parties hereto, to be invalid, illegal, or unenforceable, such provision or provisions shall be validly reformed to as nearly approximate the intent of the parties as possible and if unreformable, the provision or provisions will be excised from this Agreement. The other provisions of this Agreement shall remain in full force and effect. 14.5 Each party agrees to execute, acknowledge and deliver such further instruments Page 20 of 22 and to do all such other acts as may be necessary or appropriate to effect the purpose and intent of this Agreement. 14.6 A waiver by either party of any term or condition of this Agreement shall not be deemed or construed to be a waiver of such term or condition for any similar future instance or of any subsequent breach. 14.7 Each party shall comply with all applicable laws, rules, ordinances, guidelines, consent decrees, and regulations of any pertinent national, state, or other governmental authority. 14.8 No party shall be liable for failure to perform or delay in performing obligations set forth in this Agreement, and no party shall be deemed in breach or default of its obligations, if, to the extent and for so long as, such failure, delay, breach or default is due to natural disasters, strikes, riots, incendiaries, war, interference by civil or military authorities, compliance with governmental laws, rules, regulations, or uncontrollable delays in transit or delivery. Any party desiring to invoke the protection of this paragraph shall promptly notify the other party. 14.9 This Agreement shall be governed by, and interpreted in accordance with, English Law and the Parties submit to the non-exclusive jurisdiction of the English Courts. 14.10 In the event that the Parties cannot amicably resolve any dispute that arises under this Agreement, the matter shall be referred to a single arbitrator, to be agreed to by the parties, but in the default of such agreement, nominated by the then President of the Law Society of England. The arbitrator's decisions shall be final and binding upon the Parties. 14.11 Any notice, consent or approval permitted or required under this Agreement shall be in writing sent by overnight courier or by facsimile (confirmed by mail) and addressed as follows: University: Page 21 of 22 Cambridge University Technical Services Ltd. 20 Trumpington Street, Cambridge, Great Britain CB2 1QA Attention: Director Licensee: 2380 Walsh Avenue, Building B Santa Clara, California 95051, United States of America Attention: Chief Executive Officer All notices shall be deemed to be effective on the date of deposit with the courier service or on the date of the facsimile. If a party changes its address, prompt written notice of such change shall be given to the other party. 14.12 The relationship hereby established between University and Licensee is solely that of independent contractors. This Agreement shall not create any agency, partnership, joint venture, or employer/employee relationship, and nothing herein shall be construed to authorize either party to act for, represent, or bind the other party, except as expressed provided. 14.13 Nothing contained within this Agreement shall be construed to allow either party to utilize the name of the other, except with the prior written consent of the pertinent party, which consent shall not be unreasonably withheld. Licensee shall have the right, however, to use the name of University in materials associated with investors or potential investors, or associated with stock offerings and stock sales, and the like, without the written consent of University. 14.14 The captions or headings of this Agreement are for convenience only and are to be of no force or effect in construing and interpreting the provisions of this Agreement. Page 22 of 22 In witness thereof, the parties have caused this Agreement to be executed by their duly authorized representatives. FOR UNIVERSITY: Signature: /s/ R. C. Jennings _________________________________________ Typed Name: Dr. R. C. Jennings _________________________________________ Title: Director _________________________________________ Date: 14.10.97 _________________________________________ FOR LICENSEE: Signature: /s/ L.G. Grant _________________________________________ Typed Name: Dr. L.G. Grant _________________________________________ Title: President, Cytogenetics _________________________________________ Date: 24th Oct. 97. _________________________________________ ATTACHMENT A: CURRENT PATENT RIGHTS UK Patent Application Number 9704054.7 entitled "Chromosome-specific Paint Probes" (Priority Date: 27 February 1997). EX-10.22 4 EMPLOYMENT LETTER AGREEMENT [APPLIED IMAGING LETTERHEAD] EXHIBIT 10.22 July 21, 1997 Mr. Carl Hull P.O. Box 64086 Tucson, AZ 85728 Dear Carl, I am pleased to offer you the position of Vice President of World Wide Marketing, reporting to me. Your annual salary will be $135,000. In addition, you will be recommended for participation in the Company's Incentive Stock Option Plan at a level of 60,000 shares (subject to board approval). In line with our ISO program, the price of the shares will be the closing market price on the last trading day preceding your date of hire. You will vest 25% of your total holdings at the anniversary of your grant date. Accordingly, it will take four years to become fully vested. Should Applied Imaging be sold within the first eighteen months of your employment, one-half (or 30,000 shares) of your initial option award of 60,000 shares will become immediately vested. Should Applied Imaging be sold after that eighteen month period, but prior to the end of your fourth year of employment, all of the then-unvested portion of your initial option award of 60,000 shares will become immediately vested. In addition to your salary, you will be eligible to receive a cash bonus of up to 30% of your annual salary, based on your achievement of mutually agreed objectives. As a Company employee, you are also eligible to receive certain employee benefits, which presently include 10 days per year vacation time and 10 days per year sick leave. Applied Imaging will provide medical, dental, and life insurance for you at a minimal cost. Medical and dental insurance is also available for your dependents. Coverage beings 30 days after your date of hire. Applied Imaging also offers a 401(k) plan, matching the first 3% of the employee contribution and an employee stock purchase plan. Please be advised that employment at Applied Imaging is at-will and may be terminated with our without cause and with or without notice at any time by the employee or the Company. It is mutually understood and agreed that, should your employment be terminated by Applied Imaging, other than for "cause", you shall be entitled to receive a severance payment equal to six times your monthly base salary then in effect. It is Corporate policy that a pre-employment drug screen is required. To assist you in your permanent relocation, Applied Imaging will reimburse any reasonable expenses associated with the movement of your personal property to California, up to three house hunting trips, lease breaking expense incurred with your current rental property and up to three months temporary living expenses. In addition, the Company will provide you with a low interest loan for up to $50,000 (to be utilized as a down payment for a permanent residence in California), to be paid back over a five year period or sooner in the event of termination, under the terms and conditions set forth in Appendix 1, attached. We look forward to you joining Applied Imaging on August 4, 1997. To confirm your acceptance of this offer, please sign below and return one copy of this letter to me by July 25, 1997. Sincerely, /s/ Jack Goldstein Jack Goldstein President and CEO JG/dx attachment /s/ Carl Hull 7-22-97 - ------------- -------- Carl Hull Date EX-10.23 5 EMPLOYMENT LETTER AGREEMENT [APPLIED IMAGING LETTERHEAD] EXHIBIT 10.23 April 2, 1997 Jack Goldstein, Ph.D. 2 Glennon Farm Lane Lebanon, NJ 08833 Dear Jack, On behalf of the board of Applied Imaging, I am pleased to offer you the position of Chief Executive Officer of Applied Imaging, reporting to the Board of Directors. We have all enjoyed getting to know you, and are unanimous in our enthusiastic support of your candidacy. We are convinced that you are well qualified to lead Applied Imaging in its growth, and to make a crucial contribution to the success of the Company. Your annual salary will be $255,000. In addition you will be awarded 280,000 shares of common stock under the Company's Incentive Stock Option plan. The Company has approximately seven million outstanding shares. In line with our ISO program, the price of the shares will be determined by the market value of the shares at your starting date. You will vest 25% of your total holdings at the anniversary of your grant date. Accordingly, it will take four years to become fully vested. In addition to your salary, you will be eligible to receive a cash bonus of up to 30% of your annual salary, based on your achievement of mutually agreed objectives set by the Board of Directors. An additional 20,000 shares will be issued to you under the ISO program at the completion of one year of employment, if the board deems your performance outstanding. Our health insurance plan provides for dependent coverage until the dependent's twenty third birthday. The plan is largely company-sponsored, and depending on which HMO/PPO you select, the employee premium contribution can vary from zero to $50 per month. We also have a dental plan that is company-sponsored. You will be eligible for term life insurance coverage for two times your annual salary at no cost to you; our Long Term Disability program is a standard plan; however, we offer an LTD supplement for Corporate officers which mitigates 'loss of income' under the basic plan. In addition, Applied Imaging offers a 401 (k) retirement program wherein the Company matches your voluntary contribution up to 3% of your salary, 1997's maximum allowable voluntary contribution (as established by the federal government) is $9,500. To assist you in your permanent relocation, including the sale of your current residence and the purchase of a new home in California, Applied Imaging will reimburse your reasonable documented expenses, related to these transactions. In addition the company will reimburse you for reasonable documented expenses associated with the movement of your personal property to California and house hunting trips. Applied Imaging will also reimburse you for up to six month of temporary housing costs. Finally, the company will gross up tax liabilities which are incurred by you as a result of these relocation expenses. We look forward to you joining Applied Imaging full time during the next 45 days. To confirm your acceptance of this offer, please sign below and return one copy of this letter to me by Friday, April 11, 1997. Jack, on a personal basis, I am looking forward to working with you. I firmly believe that this is an exciting and challenging opportunity in which you can make a significant contribution. We all look forward to welcoming you aboard. Regards, /s/ Abe Coriat Abe Coriat Chairman of the Board AC/dx /s/ Jack Goldstein 4/5/97 - ------------------ ------ Jack Goldstein, Ph.D. Date [Applied Imaging Letterhead] April 4, 1997 Jack Goldstein, Ph.D. 2 Glennon Farm Lane Lebanon, NJ 08833 Dear Jack, Per my discussions with John Archer, the following is an addendum to my offer letter dated April 2nd. 1. In the event of the company terminating your employment for a reason other than cause, the company will continue paying your salary for a period of 12 months after your termination date. 2. I understand that it is your intention to start looking for a house to purchase, and to sell your current house, as soon as you begin your employment with Applied Imaging. In addition to the six months mentioned in the offer letter, the company will grant you up to two three-months extensions to cover reasonable temporary housing cost on an as needed basis, should it be required. 3. In the event of change in control due to a merger or acquisition of the company, the vesting of your shares will be accelerated, but only if the acceleration provision will not preclude the structuring of the proposed merger or acquisition as a pooling of interests, if this is the structure approved by the Board of Directors. 4. The price of your shares will be determined by the market value of the shares at your starting date. We will announce your ernployment with Applied Imaging after your starting date. 5. I understand that you intend to take vacations with your wife between July 2nd and July 11th. July 4th is independence day, as part of your vacations you could also celebrate your independence from J&J!! May I say again how much we all welcome you to Applied Imaging -- and we look forward to you joining us soon. Regards, /s/ Abe Coriat /s/ Jack Goldstein, PhD Abe Coriat 4/5/97 Chariman of the Board EX-23.1 6 CONSENT OF KPMG PEAT MARWICK LLP EXHIBIT 23.1 CONSENT OF INDEPENDENT AUDITORS The Board of Directors Applied Imaging Corp.: We consent to incorporation by reference in the registration statement (No. 333-26127) on Form S-8 of Applied Imaging Corp. of our report dated February 6, 1998, relating to the consolidated balance sheets of Applied Imaging Corp. as of December 31, 1997 and 1996, and the related consolidated statements of operations, stockholders' equity, and cash flows for each of the years in the three-year period ended December 31, 1997, and the related financial statement schedule, which report appears in the December 31, 1997, annual report on Form 10-K of Applied Imaging Corp. KPMG Peat Marwick LLP Mountain View, California March 27, 1998 EX-27.1 7 FINANCIAL DATA SCHEDULE
5 12-MOS 12-MOS DEC-31-1996 DEC-31-1997 JAN-01-1996 JAN-01-1997 DEC-31-1996 DEC-31-1997 12,318 2,918 0 5,460 1,682 3,549 (228) (191) 831 849 14,939 12,853 3,304 4,557 (2,070) (2,764) 16,473 14,714 4,239 5,682 0 0 0 0 0 0 25,576 29,644 (13,571) (20,701) 16,473 14,714 9,259 10,457 11,922 13,134 4,501 5,188 5,974 6,284 8,843 14,760 62 (37) 86 39 (2,895) (7,910) 4 34 (2,881) (7,512) 0 0 0 0 0 0 (2,881) (7,512) (1.43) (1.03) (1.43) (1.03)
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