-----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, RgCshA60lwoNyCFatJI+mYSA3eZHLWejJvfJvrq38uw0sIqlErK0V2rq8oGgsnmB RNdnxsOkzppJ3u8f3YjkCA== 0000950149-00-000466.txt : 20000309 0000950149-00-000466.hdr.sgml : 20000309 ACCESSION NUMBER: 0000950149-00-000466 CONFORMED SUBMISSION TYPE: 10-K PUBLIC DOCUMENT COUNT: 8 CONFORMED PERIOD OF REPORT: 19991231 FILED AS OF DATE: 20000308 FILER: COMPANY DATA: COMPANY CONFORMED NAME: AXYS PHARMECUETICALS INC CENTRAL INDEX KEY: 0000913056 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 222969941 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-K SEC ACT: SEC FILE NUMBER: 000-22788 FILM NUMBER: 563126 BUSINESS ADDRESS: STREET 1: 180 KIMBALL WAY CITY: SOUTH SAN FRANCISCO STATE: CA ZIP: 94080 BUSINESS PHONE: 6508291000 MAIL ADDRESS: STREET 1: 180 KIMBALL WAY CITY: SOUTH SAN FRANCISCO STATE: CA ZIP: 94080 FORMER COMPANY: FORMER CONFORMED NAME: ARRIS PHARMACEUTICAL CORP/DE/ DATE OF NAME CHANGE: 19931005 10-K 1 FORM 10-K 1 - -------------------------------------------------------------------------------- - -------------------------------------------------------------------------------- UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 ------------------------ FORM 10-K ------------------------ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 1999 COMMISSION FILE NO. 0-22788 AXYS PHARMACEUTICALS, INC. (EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER) DELAWARE 22-2969941 (STATE OF OTHER JURISDICTION OF (I.R.S. EMPLOYER INCORPORATION OR ORGANIZATION) IDENTIFICATION NO.)
180 KIMBALL WAY, SOUTH SAN FRANCISCO, CALIFORNIA 94080 (ADDRESS OF PRINCIPAL EXECUTIVE OFFICES, INCLUDING ZIP CODE) REGISTRANT'S TELEPHONE NUMBER, INCLUDING AREA CODE: (650) 829-1000 SECURITIES REGISTERED PURSUANT TO SECTION 12(B) OF THE ACT: NONE SECURITIES REGISTERED PURSUANT TO SECTION 12(G) OF THE ACT: COMMON STOCK $.001 PAR VALUE PREFERRED SHARE PURCHASE RIGHTS (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 past 90 days. Yes [X] No [ ] Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (Section 229.405 of this chapter) 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. [ ] The approximate aggregate market value of the voting stock held by nonaffiliates of the Registrant as of February 29, 2000, based upon the last trade price of the Common Stock reported on the Nasdaq National Market on such date, was $553,602,928.* The number of shares of Common Stock outstanding as of February 29, 2000 was 34,946,051. DOCUMENTS INCORPORATED BY REFERENCE Portions of the Registrant's Proxy Statement which will be filed with the Commission pursuant to Section 14a in connection with the 2000 annual meeting of stockholders are incorporated herein by reference in Part III of this report. * Excludes approximately 345,868 of the Registrant's outstanding Common Stock held by directors and officers of the Registrant at February 29, 2000. Exclusion of shares held by any person should not be construed to indicate that such person possesses the power, direct or indirect, to direct or cause the direction of the management or policies of the Registrant, or that such person is controlled by or under common control with the Registrant. - -------------------------------------------------------------------------------- - -------------------------------------------------------------------------------- 2 PART I. ITEM 1. BUSINESS INTRODUCTION This section discusses the business of Axys Pharmaceuticals, Inc. In this section we sometimes refer to Axys Pharmaceuticals, Inc. as Axys or our company. For further information you may contact our web-site at www.axyspharm.com. You should be aware that the following discussion of our company contains both historical information and forward-looking statements. Forward-looking statements are statements made about future events and include projections and other statements about what may or could happen in the future. You should be aware that forward-looking statements involve risks and uncertainties. Our actual results could differ significantly from those you might expect based on our forward-looking statements. There are a number of reasons that this might occur. To understand what those reasons are, you should review the sections below entitled "What Factors Could Cause Our Results to Differ Materially from Those You Might Expect?" and "What Other Matters Should Stockholders Consider with Respect to the Company?". You should also consider the additional risk factors described in the section entitled "Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations." OVERVIEW Axys is a biopharmaceutical company focused on the discovery, development and commercialization of therapeutic small molecules. We focus our own resources on discovering and developing therapeutics for the treatment of various types of cancer and we collaborate with large pharmaceutical companies in discovering therapeutics for chronic diseases for which there are large markets. We have three affiliated companies that were formed to provide capital to Axys for our drug discovery operations: - AXYS ADVANCED TECHNOLOGIES, INC. (AAT), which began operations in 1996, is a 100% owned subsidiary that markets combinatorial chemistry compounds, enabling technology and services. - PPGX, INC. (PPGx), a pharmacogenomics subsidiary founded in 1999, is 82% owned by Axys. - AKKADIX CORPORATION (Akkadix), previously called Xyris Corporation, an agricultural biotechnology company founded in 1998, is 38% owned by Axys. WHAT GIVES US AN EDGE IN DRUG DISCOVERY AND DEVELOPMENT? The entire drug discovery process runs from target identification and validation to lead identification to preclinical development to clinical development. The following sections describe each part of this process and the technologies that Axys employs in drug discovery. In recent years, the advent of new drug discovery technologies, including genomics, bioinformatics, computational sciences, structure-based drug design, combinatorial chemistry, high throughput screening and pharmacogenomics, has offered great potential for streamlining the lengthy and expensive process of drug discovery. We have assembled a premier platform for drug discovery by combining and integrating these new technologies with the traditional pharmaceutical sciences, including medicinal chemistry and pharmacology. Our capabilities in this area, which include assay development, compound screening, lead optimization, pharmacology and preclinical development, are instrumental in increasing the speed and efficiency of our drug candidate identification efforts. In addition, we have functional genomics capabilities, which we are using to select and validate targets for our cancer research. As a biopharmaceutical company, our core strengths lie in the portion of the drug discovery continuum spanning from selection of leads from hits in primary screens, lead optimization using structure-based drug design, combinatorial chemistry, to preclinical development and pharmacology. In this regard, we believe we 2 3 are unique among biotechnology companies in having an in-house medicinal chemistry group of the size and scope usually found in large pharmaceutical companies. TARGET IDENTIFICATION AND VALIDATION Target identification and validation is the process of identifying and validating those genetic-based targets that are the most promising for therapeutic intervention by small molecules. There are numerous potential targets, which may apply to all manner of diseases. As described below, we are currently focusing our target identification and validation efforts on discovering new biochemical pathways in cancer. The human genome is the collection of all the genetic information of a human being. Scientifically defined, the human genome consists of 23 pairs of chromosomes that contain the 100,000 or so genes that define every human's make-up. Genes are made up of DNA (deoxyribonucleic acid). In humans, a DNA molecule resembles a twisted ladder and consists of two strands -- a double helix -- whose carbohydrate-like sides are connected by pairs of nitrogen-containing chemicals called bases, which form the rungs of the ladder. The particular order of the bases is called the DNA sequence. In total, there are approximately 3 billion base pairs of DNA comprising all of the chromosomes in the human genome. Much effort has been devoted by various governments, research institutions and companies to mapping out the exact location of each gene on each chromosome in order to determine the complete DNA sequence of the 3 billion DNA bases. We believe that detailed knowledge of the human genome is or will be available in the near future, either through public databases or through commercially available databases. However, knowing the sequence of a gene is really only the beginning of the drug discovery process. The next step is the determination of the biological processes that the gene plays a role in. The term "functional genomics" refers to a variety of scientific disciplines that examine gene function and identify disease pathways resulting from a gene or genes that are not functioning properly. The job of determining the functions of a gene -- and its protein products -- requires testing in systems that approximate human systems, such as the C. elegans (nematode worm) system. Although we were a pioneer in genomics research using positional cloning techniques in many different disease areas, we concluded in 1999 that many of our genomics programs were too early stage and too far removed from product development to justify the sizeable investment that we were making. So, during the last half of 1999 we wound down our formerly partnered genomics research programs, transferred our last remaining partnered genomics research program to our partner (the Parke-Davis Pharmaceutical Research Division of the Warner-Lambert Company) and shut down our La Jolla research facility. We continue to utilize our genomics capabilities as part of our cancer research programs and moved them to our South San Francisco site in the fall of 1999. We have integrated these capabilities with our functional genomics capabilities to create a directed set of target identification and validation tools, which include bioinformatics, a sophisticated antisense knock-out technology, expression array technology and C. elegans nematode biology, all of which we use to discover new biochemical pathways in cancer. Axys makes use of both proprietary and licensed bioinformatics software to enable the discovery of new genes and the identification of known genes and species homologs in the our efforts in target identification and validation. When new gene sequences are identified, we are rapidly able to access both public and proprietary databases through these software tools. We have, in particular, developed a proprietary Target Validation System, which we refer to as TVS, which is used to collect all data gathered on particular genes, including sequence, and correlation to possible function. Where the function of a gene needs to be determined, especially in the case where it might play a pivotal role in a biochemical process, we can use antisense knock-out technology, either in well-characterized functional systems, such as the nematode worm, or in mammalian systems. For most applications of antisense as applied to specific new targets, we have licensed the technology from Atugen. We also employ sophisticated expression array technology, licensed from Molecular Dynamics-Amersham. Using this technology, very small arrays are built on glass slides to study the expression levels of thousands of genes at the same time. With the information generated from these arrays, we can compare differences in gene expression between normal and diseased or genetically manipulated cells. Finally, another technology we use is C. elegans, a microscopic multicellular round worm that is the most thoroughly 3 4 understood multicellular animal in terms of cellular development, anatomy and genetic content. C. elegans is useful as a research tool because as many as 70% of the currently known human disease genes possess a highly significant homolog (sister gene) in the nematode. In addition to nematodes, we also use other model systems such as fruit flies, yeast and mice to test the function of genes. By combining gene expression data and our antisense results with information about genetic relationships gained from model systems and our bioinformatics capabilities, we are better able to identify points in biological pathways that may be the best point of intervention a potential therapeutic. For a description of some of our more significant target validation and identification activities in cancer in 1999, see the section below entitled "What Does Axys' Non-Partnered Research and Development Franchise in Oncology Look Like?" Lead Identification Once a biological point of intervention or target, is identified and validated, we have the capability to rapidly identify chemical compounds that chemically regulate the protein product of the relevant gene called a lead. We have generated lead compounds for new biological targets at a rapid pace by making use of a broad range of technologies in dual discovery tracks: (1) structure-based drug design driven by X-ray crystallography and computational modeling and (2) high-throughput screening combined with chemical compound diversity. We use a broad range of scientific capabilities to study the basic structure of molecules (X-ray crystallography) and advanced chemistry that uses the knowledge gained from crystallography and structural biology. These technologies can speed research by enabling an understanding of the precise three-dimensional structure of a target associated with a disease. Then, we bring additional computational science capabilities into play. We have a rapid, flexible molecular docking model that can be used to find a natural or synthetic "inhibitor" that can bind to the molecule and change the way it will perform in the body. By using structure-based design, we have the ability to rapidly create lead compounds that are less likely to cause side effects, be toxic or result in lengthy delays in drug development due to failed safety studies. Our medicinal chemists also play an important role in our lead identification efforts. The chemists obtain iterative structural information from X-ray crystallography and molecular modeling, complemented by powerful computational resources and coupled with production-level protein expression and purification, all of which enables them to develop and refine target compound families. Our particular strength is in the determination of serine and cysteine protease protein structures, and the design of small molecules with potency and specificity among these closely related protein family members. Proteases are enzymes, which play a critical role in virtually every biological process. We believe the ability to develop inhibitors of proteases may give us important advantages in our drug discovery activities. Our combinatorial chemistry expertise compliments our structure-based design activities. Combinatorial chemistry capabilities are particularly useful where there is little known structural information. We have created compound diversity libraries through our AAT subsidiary, which has synthesized over 400,000 individual compounds to date, and is projected to have made a total of 700,000 such compounds, encompassing over 140 distinct sub-libraries, by year-end 2000. The medicinal and combinatorial chemists of AAT are able to generate a wide variety of diversity or lead optimization libraries, depending on our needs. Assays for high-throughput screening are adapted for automation and validated for screening against diverse chemical structures to provide data with a low false positive hit rate. Screening hits are rapidly confirmed or eliminated based on follow-up assays, and are qualified for further library expansion and medicinal chemistry based on novelty, potency and selectivity criteria. To screen these libraries we use automated robotics systems. These robots test the binding activity of thousands of compounds against a disease target, usually a protein. This binding activity is a measure of the compound's ability to inhibit or potentiate the activity of the protein. The primary role of the technology is to detect active compounds and supply directions for their optimization using other techniques. Given the variety and size of chemical libraries available today, and the need to compare the results from multiple screenings, data collection and management of information are critical elements of high throughput screening. We 4 5 maintain data bases of structures, assays performed, screening results and other similar information in relational data bases, which can be queried from any number of research parameters. OPTIMIZATION, PRECLINICAL DEVELOPMENT AND CLINICAL DEVELOPMENT Once a lead candidate has been identified, the most resource-intensive stage of the pharmaceutical discovery process begins. This is the process of identification of a preclinical candidate with the desired pharmaceutical product profile. It requires directed medicinal chemistry efforts coupled closely with pharmacokinetics, drug metabolism and efficacy studies in pharmacology. Our experience in six such programs partnered with major pharmaceutical companies during the last five years has resulted in an integration of effort by our medicinal chemists and our pharmacology group. We believe that we are unique among biotechnology companies in having an in-house medicinal chemistry group of the size and scope usually found in large pharmaceutical companies. We use our medicinal chemistry capabilities to improve the potency, selectivity (won't bind to wrong target), oral bioavailability (compound can be absorbed by the body when taken orally as a pill), metabolic stability (how rapidly the body breaks down the compound), and biological half-life (how long the effects of the drug will last) of a drug candidate. Among our own medicinal chemistry tools is our patented Delta Technology, which enhances the ability of lead compounds to act against some proteases implicated in a broad range of diseases. In December 1997, the United States Patent and Trademark Office issued us a patent providing us with broad protection of our Delta Technology. The patent and subsequent issued patents on the same subject, pertains to technology useful in research for the discovery of unique protease inhibitors. Delta Technology enables researchers to take a common element that is always in the blood -- zinc -- and use it to increase the binding potency of a drug candidate. Before qualifying for evaluation in human trials, chemical compounds must pass extensive safety and effectiveness tests. In such tests, we use cell-based and animal-based models of human disease to provide important information on how long the drug effects last or the duration of action of a potential drug, as well as how it is absorbed by the body or metabolized. On-site studies take advantage of advanced technologies, such as mass spectrometry (a sensitive analytical method to identify a compound and the products into which it is broken down), to evaluate hundreds of samples, indicating not only drug concentrations but also the pharmacodynamic (what the drug does to the body) and the pharmacokinetic (what the body does to the drug) characteristics of compounds nearing human clinical trials. In addition, we can use pharmacogenomics capabilities in our preclinical and clinical development efforts. Pharmacogenomics is the use of genetic and genomic information to predict the response of individual patients and patient populations to drugs. Through our PPGx subsidiary we have developed and are continuing to develop our bioinformatics platform and computer-based tools to link genetic data from drug development and medical practice with worldwide genomic databases. These tools allow us to better determine which patients will respond to the compounds being tested, as well as eliminate those who may be at risk of adverse reactions. We believe that pharmacogenomics will revolutionize clinical trials, improve the success rate of clinical development and reduce development time and cost. Finally, while some of our collaborative partners provide clinical development expertise, we also have an in-house clinical development group, with extensive prior experience in managing clinical trials, satisfying regulatory requirements, ensuring manufacturing quality control and quality assurance, this group is taking our products forward into human testing. 5 6 WHAT DOES AXYS' NON-PARTNERED RESEARCH AND DEVELOPMENT FRANCHISE IN ONCOLOGY LOOK LIKE? PROPRIETARY PIPELINE -- ONCOLOGY
SCREENING/ PROOF OF CONCEPT PRECLINICAL ---------- ----------- Urokinase -- Angiogenesis/metastasis.................................... X Axys Serine Protease (ASP) 05 -- Tumor suppressor protein............... X SERM-b -- Selective estrogen receptor modulators (Beta)................. X Cathepsin B -- Solid tumor metastasis....................... X Prostate Specific Antigen -- Prostate cancer................ X Urokinase receptor antagonists.............................. X Histone deactylase inhibitors............................... X Methionine aminopeptidase-2 inhibitors...................... X MT1-MMP inhibitors.......................................... X HIF1-a modulators........................................... X CAAX-2 protease inhibitors.................................. X
In early 1999 we implemented an initiative to focus our unpartnered resources on the development of small molecule therapeutics for the treatment of cancer. We believe that there is a significant market opportunity to meet current and future medical needs associated with many different types of cancer. One of the factors contributing to this growth is the aging of the world's population. As people live longer, cancer becomes more prevalent. Our decision to focus our resources on cancer therapeutics was also partly based on the improving regulatory environment for approval of cancer therapeutics. In recent years, the FDA has established a regulatory "fast track" for some cancer therapeutics approved reviews. In addition, surrogate markers such as tumor shrinkage have been increasingly accepted as research endpoints. The use of surrogate markers may substantially shorten the length of the necessary clinical research studies. Further, the company believes that protease inhibition may provide a treatment method for many cancers, resulting in orally delivered small molecule therapeutics. These include antiangiogenesis, hypoxia and metastasis inhibition. Angiogenesis is the process by which blood vessels are formed. Blood vessel formation and growth is necessary for tumor growth. Antiangiogenesis drugs are believed to be able to cut off blood vessel growth and thereby reduce the size of tumors and potentially interfere with their growth. Hypoxia is the deprivation of oxygen to tumor cells, which can lead to the inhibition of tumor cell proliferation. Metastasis is the process by which cancer spreads. Drugs which discourage metastasis are believed to be able to stop cancer from spreading throughout the body. We have had research programs underway that range from a preclinical program in antiangiogenesis to screening and proof-of-concept programs in solid tumor metastasis, prostate cancer and the insulin growth factor (IGF) pathway to cancer target identification and validation research programs. Urokinase. One of our most advanced oncology programs involves the development of inhibitors of the protease urokinase to interfere with angiogenesis and metastasis processes. Utilizing a broad range of scientific capabilities including crystallography and structural biology, our scientists have extensively analyzed urokinase to identify sites on the molecule best suited for drug interaction. Using our medicinal chemistry and structure-based drug design capabilities, a series of drug-like compounds have been screened to identify potential drugs and select a candidate for preclinical development. Our lead series of urokinase inhibition drug candidates have been shown in preclinical testing to be potent and specific which may reduce the chance of unwanted side effects. The results to date of our tests in animal models show that urokinase may be required for tumor metastasis, and preclinical studies have shown activity 6 7 of a urokinase inhibitor in animal models. We plan to select an IND candidate from the urokinase inhibition program in 2000. ASP05. Axys is also developing as a protein therapeutic Axys Serine Protease (ASP) 05, a proprietary tumor suppressor protein discovered in our protease targeted genomics program. ASP05 is currently being scaled in production and purification to be evaluated in in vivo xenograft tumor models. Pending successful outcome of these studies, ASP05 would advance into IND candidate status in 2000. SIGNAL SERM-b. Our first in-licensed program in oncology comes from Signal Pharmaceuticals. In October 1999 Signal granted us exclusive rights to their selective estrogen receptor-beta modulators (SERM-b) for the treatment of cancer. SERM-b compounds are small molecules that selectively modulate the activity of the newly discovered beta estrogen receptor found in tumors and certain hormonally sensitive tissues. Preclinical studies are expected to continue throughout 2000. Screening/Proof-of-Concept. Particular areas of emphasis in our early-stage research include hypoxia and angiogenesis. Biological targets identified in these pathways can be validated as small-molecule drug targets through additional molecular biology and eventual screening. In 1999, six oncology targets -- urokinase receptor antagonists, histone deactylase, methionine aminopeptidase-2, MT1-MMP, HIF1-a, and CAAX-2 protease -- were entered into high-throughput screening by this process. Two additional protease targets, prostate-specific antigen (PSA) and Cathepsin B, are being validated in vivo using antisense and chemical inhibitor approaches. In addition to these programs, we are continuing to actively seek to license potential cancer treatment compounds from other biotechnology or pharmaceutical companies with an emphasis on the pre-clinical and early stage clinical product opportunities. WHAT DRUG DISCOVERY PARTNERSHIPS WITH WORLD-CLASS PHARMACEUTICAL PARTNERS DO WE HAVE? PARTNERED PIPELINE (PRECLINICAL & CLINICAL)
PRECLINICAL CLINICAL ----------- -------- Bayer AG -- Asthma (Tryptase)............................................ X Bayer AG (option) -- IBD (Tryptase)...................................... X Merck & Co. -- Osteoporosis (Cathepsin K)................... X Aventis -- Inflammation (Cathepsin S)....................... X Seeking to repartner -- Thrombosis (Factor Xa/VIIa)......... X
Bayer AG (Tryptase Inhibitors/Asthma/Clinical Phase I in 1H 2000) In 1994 we entered into an agreement with Bayer AG for the research and development of tryptase inhibitors for the treatment of asthma. Tryptase is a serine protease that has been shown to regulate inflammation. Tryptase is released by mast cells as part of an immune response to allergens such as pollen, mold or grasses and contributes to several biological events which result in inflammation. Our tryptase inhibitors are designed to slow or halt the inflammatory process at an early stage, in an attempt to provide safe and effective therapies for the treatment of the underlying cause of disease, rather than the symptoms. The most significant indication for tryptase inhibitors is allergic asthma, as a replacement for inhaled steroid therapies. Asthma is characterized by generalized airway inflammation and tightness in the lungs (bronchoconstriction) which makes breathing difficult. Five percent of the United States population, or approximately 13 million people, are estimated to suffer from some form of asthma. The exact causes of asthma are not well understood, and current treatments for asthma include controlling inflammation through the use of inhaled 7 8 steroids, treating airway constriction through the use of bronchodilators and prevention of asthma attacks through the daily use of oral leukotriene inhibitors. In our collaboration with Bayer, we have established human proof-of-concept for tryptase as a drug target. This was achieved in previous Phase II clinical studies of APC 366, an inhaled peptide tryptase inhibitor, which showed that inhibiting tryptase resulted in improved breathing (reduction in late airway response) in asthmatics. Bayer is currently in development with a later generation compound, BAY 44-3428, a small molecule tryptase inhibitor with high oral bioavailability and circulating half-life. Bayer plans to commence Phase I clinical trials in the first half of 2000, with the goal of developing BAY 44-3428 as a once-a-day oral therapeutic for the prevention and chronic treatment of asthma. Bayer AG (Tryptase Inhibitors/Inflammatory Bowel Disease/Clinical Phase II) In July 1997, we modified our 1994 research and development agreement with Bayer to re-acquire the rights to develop tryptase inhibitors for the treatment of inflammatory bowel disease, and psoriasis which, like asthma, is another mast cell regulated inflammatory disease. Inflammatory bowel disease generally refers to two diseases: Ulcerative colitis and Crohn's disease. Over 500,000 people in the U.S. suffer from inflammatory bowel disease. Current therapies, which include the use of corticosteroids and immunosuppressants such as cyclosporine and methotrexate, expose patients to significant side effects. Phase II clinical trials are currently underway in the United States, under our sponsorship, for the treatment of ulcerative colitis with APC 2059, a second generation tryptase inhibitor administered by subcutaneous injection. Upon the conclusion of Phase II clinical studies for this indication, Bayer has the ability to reacquire from us the rights to further develop APC 2059 for this indication. If Bayer does decide to re-acquire this compound, Bayer would pay an option fee, which is equal to a multiple of development costs incurred to date, and would be obligated for additional milestone payments and royalties to Axys. In November 1999, Axys announced that the discontinuation of further development of topical cream-based formulation on APC 2059 for psoriasis based on an analysis of results during a planned interim evaluation of a phase II study. Merck (Cathepsin K Inhibitors/Osteoporosis/Preclinical) In November 1996 we entered into a research and development collaboration with Merck & Co. to develop small molecule inhibitors of cathepsin K for the treatment of osteoporosis. Osteoporosis is a disease of the bones that results in weakened bones which leads to pain, difficulty in moving, deformity and fractures. This condition mainly affects elderly women. Cathepsin K belongs to a class of enzymes called cysteine proteases. It is known to be secreted in excessive amounts by osteoclasts. In the healthy human body, osteoblast cells are responsible for bone-building while osteoclasts are responsible for bone degradation. By maintaining a careful balance in each type of cell's activity, normal bone remodeling and skeletal integrity is achieved. However, when the rate at which bone is destroyed by the osteoclasts exceeds the rate at which new bone is produced by osteoblasts, the result is excessive bone degradation (bone resorption) -- a condition that results in brittle bones and is characteristic of osteoporosis. In February 1997, we announced the first-ever solution of the three-dimensional crystal structure of cathepsin K. In December 1999, we announced the successful testing of a specific, selective cathepsin K inhibitor compound in an animal efficacy model, which triggered a milestone payment to us. In addition, although the research and development relationship was originally schedule to end after two years and had already been extended for one additional year, we agreed with Merck in December 1999 to extend this collaboration for another additional year until early November 2000. Axys and Merck are in the process of identifying a candidate for IND-enabling studies planned to commence in late 2000. 8 9 Aventis (Cathepsin S inhibitors/Inflammatory Diseases/Preclinical) In December 1998 we entered into a collaborative research and development agreement with Aventis, S.A. (successor to Rhone-Poulenc Rorer). The objective of the collaboration is the discovery and development of small molecule therapeutics that inhibit cathepsin S, a human cysteine protease associated with certain inflammatory diseases. The collaboration is for two years and may be extended by Aventis for two additional one-year periods. Cathepsin S is a cysteine protease found in antigen-presenting cells of the immune system. Unlike many other proteases, it is rarely found in other types of cells. Cathepsin S is believed to function in a pathway that regulates the body's ability to fight off these foreign antigens, leading to an inflammatory reaction. As a result, it may be possible to use inhibitors of cathepsin S to block the pathway and consequently protect the body from certain inflammatory diseases and perhaps autoimmune disorders. Our researchers were the first to solve the three-dimensional X-ray crystal structure of cathepsin S, as reported in June 1998 in Protein Science. Cathepsin S is associated with some inflammatory diseases, including arthritis, asthma, atherosclerosis and a variety of autoimmune diseases. Under the terms of the agreement, Aventis has exclusive development and marketing rights to cathepsin S protease inhibitors for respiratory diseases, atherosclerosis and related conditions and rheumatoid arthritis. Rheumatoid arthritis affects approximately 2.5 million Americans. Coronary heart disease is caused by the atherosclerotic narrowing of the coronary arteries and is the number one cause of death in United States with approximately 500,000 deaths occurring annually. Stroke is the third leading cause of death in the United States, with approximately 160,000 deaths occurring annually. In November 1999, we announced the successful testing of a potent, selective cathepsin S inhibitor compound in an animal efficacy model of asthma and received a milestone payment. In addition, current in vivo proof-of-concept studies are underway and planned for rheumatoid arthritis and atherosclerosis. Aventis is seeking to identify a candidate for IND-enabling studies scheduled to commence in late 2000. No Current Partner (Factors Xa & VIIa & Thrombin Inhibitors/Blood Clotting Disorders/Preclinical) In September 1995, we signed a collaboration agreement with the company that is now known as Pharmacia & Upjohn, Inc. to develop oral therapeutics for blood clotting disorders, such as deep vein thrombosis, stroke, and myocardial infarction. More specifically, we had been using our Delta technology and other technologies to discover inhibitors of Factors Xa and VIIa and thrombin, all of which are serine proteases. In July 1998 the research support for this collaboration ended and in February 1999 we formally agreed to end this collaboration. We are, however, continuing our research efforts and are actively seeking a new partner for this program. At the present time, we are continuing to work on the development of compounds, which could result in the nomination as a clinical candidate. Factor Xa, factor VIIa and thrombin are three enzymes involved in the blood clotting process. All three are serine proteases that have been acknowledged as targets for a host of disorders related to abnormal clotting. Annually, more than 2 million people are hospitalized in the United States for deep vein thrombosis, acute myocardial infarction and unstable angina. WHY AND HOW HAVE WE LEVERAGED OUR TECHNOLOGY PLATFORM? We will need additional capital in order to continue our research and development efforts. One way we hope to be able to raise additional capital is through creating separate companies using our technologies for purposes other than drug discovery. To accomplish this, we have created three businesses (combinatorial chemistry, agricultural biotechnology, and pharmacogenomics). At the same time, we are retaining the intellectual property and assets that these businesses also make use of for our own drug discovery and development purposes. In creating these businesses, as separate entities our business model contemplates that each business should have - access to and ownership (if necessary) of our relevant technologies, so that they can continue to pursue their respective businesses independently, 9 10 - independent management focused on their business, and - funding from third parties, as necessary, so that we do not have to divert our own capital from drug discovery. While the third parties who provide capital for these businesses acquire an equity ownership position in the businesses, we have retained a sizeable equity ownership position. Having set up these businesses, secured financing for them and provided additional business support as necessary, we have positioned ourselves to receive additional capital by selling some or all of our equity position in each of these businesses. This could happen in one or more of the following ways: - a sale of our equity interest in the business in the course of a public offering of securities for that business, - the sale of our equity interest in the business to a third party; or - a sale of the business to the third party who has provided it with funding or to some other company. While we believe that we will be successful in realizing meaningful value from these affiliated businesses, our ability to do so will depend on the success of these businesses in executing their business strategies. There can be no assurance that these affiliated businesses will be successful or that we will have the ability to sell all or a portion of our equity ownership in these businesses. In addition, there can be no assurance that the amount we may receive upon selling our equity ownership interest will provide significant funding so as to postpone for a meaningful time period the need to engage in other capital formation activities. HOW AND WHEN WERE THESE AFFILIATED BUSINESSES SET UP? The first affiliated business was established in 1997 and spun out as a subsidiary in 1999 was our combinatorial chemistry business, which is now called Axys Advanced Technologies, Inc. (AAT). Its web-site is located at www.axystech.com. It has its own management team and handles the research, development, sales, marketing and production of its products, including combinatorial chemistry libraries and related technology developed as part of our drug discovery efforts beginning in 1995. AAT is evaluated by Axys on a separate stand alone basis except for certain overhead allocations. In 1999, AAT produced positive cash flow. We have not needed to seek third party funding for AAT, and we are continuing to actively seek other ways in which AAT would help to fund our drug discovery business. AAT conceives, produces and sells large numbers of diverse combinatorial chemistry libraries of drug-like compounds, as well as more focused libraries based around a specific structure. In addition, AAT sells the protocols which provide the basis for making the libraries that are produced and which also provide the basis to make other similar drug-like compounds. The customers of AAT, including Axys, screen these drug-like compounds against biological targets of interest in an effort to identify lead compounds for their drug discovery programs. AAT also provides its enabling technology to certain customers. AAT's customers include major pharmaceutical companies such as Pharmacia & Upjohn, Parke-Davis, Aventis (formerly Rhone-Poulenc Rorer), Daiichi, Allergan, Searle and Bristol-Myers Squibb, as well as biotechnology companies such as Signal Pharmaceuticals, Protein Design Labs, Cephalon and Novalon. In most cases, these contracts provide for the sale of libraries of hundreds of thousands of non-exclusive or co-exclusive drug-like compounds over several years. In some cases the sale of these libraries is accompanied by the sale of the applicable protocols which describe how to remake the libraries. In addition, AAT also offers a program that provides access to its combinatorial chemistry software tools and that teaches a company how to establish its own combinatorial chemistry program. See Note 13 to "Notes to Consolidated Financial Statements" for Segment Information. The second affiliated business, now called Akkadix Corporation, was formed in 1998 to apply the genomics technologies acquired through the Sequana merger in 1998 to agricultural use. Its web-site is located at www.akkadix.com. Akkadix, formerly known as Xyris, is a global agricultural biotechnology company that uses gene discovery, functional genomics, bioinformatics, structural biology, combinatorial chemistry and robotic high-throughput screening to discover new products which impact our day-to-day lives in a number of 10 11 areas through improvements in agriculture. By virtue of two acquisitions during 1999, Akkadix has exclusive access to five different plant genes in selected crops, licensed from the Salk Institute, and numerous types of proprietary germplasm to provide a complete genetic research platform for the discovery of new agricultural products. Akkadix is run by Dr. Jerry Caulder, the former Chairman and CEO of Mycogen, a diversified agribusiness and biotechnology company acquired by Dow Chemical Company in 1998. During his 14 years at Mycogen, Dr. Caulder guided Mycogen from a start-up venture to a leadership position in the agbiotech market. Prior to joining Mycogen, he spent over 15 years with Monsanto Company, where he managed various aspects of both the international and domestic business of Monsanto Agricultural Products Company. A San Francisco-based merchant bank and advisory partnership has provided substantially all of the initial capital for the business in exchange for a minority ownership position. We currently own approximately 38% of the outstanding shares of Akkadix. The third affiliated business, called PPGx, Inc., was formed early 1999 to apply genomics technologies from Sequana to clinical trial design and monitoring. Its web-site is located at www.ppgx.com. PPGx provides a complete and integrated package of pharmacogenomics products and services to the pharmaceutical and biotechnology industries in drug development. Pharmacogenomics is the use of genetic and genomic information to predict the response of individual patients and patient population to drugs. PPGx offers high quality and secure DNA banking, high throughput genotyping, rapid genotyping assay development, polymorphism discovery and gene expression analysis, clinical trial design and analysis, a bioinformatics- suite of software products (known as GeneTrials LIMS Version 1.0) and consulting services to support pharmacogenomics. PPGx is being run by Dr. Joshua S. Baker, the former executive vice president of global operations for PPD Development, Inc., a leading global clinical research organization. PPGx has incorporated Axys' advanced technology platform, including Axys' genetic sequencing technology, proprietary bioinformatics software and databases into its product offering. PPD, Inc., a contract research organization, provides the sales and marketing support for PPGx. Axys currently owns more than a majority of the outstanding shares of PPGx. WHAT FACTORS COULD CAUSE OUR RESULTS TO DIFFER SIGNIFICANTLY FROM THOSE YOU MIGHT EXPECT? IF WE FAIL TO DISCOVER OR DEVELOP OR ARE DELAYED IN THE DEVELOPMENT OF PHARMACEUTICALS, OUR BUSINESS AND RESULTS OF OPERATIONS WILL BE ADVERSELY AFFECTED. All of our potential pharmaceutical products are in various stages of research and development and will require significant additional research and development efforts before we can sell them. These efforts include extensive preclinical and clinical testing and lengthy regulatory review and approval by the FDA. The development of our new pharmaceutical products is highly uncertain and subject to a number of significant risks. We do not expect any of our pharmaceuticals to be commercially available for a number of years. Pharmaceuticals that appear to be promising at early stages of development may not reach the market for a number of reasons, including the following: - We or our collaborators may not successfully complete any research and development efforts; - Any pharmaceuticals we develop may be found to be ineffective or to cause harmful side effects during preclinical testing or clinical trials; - We may fail to obtain required regulatory approvals for any products we develop; - We may be unable to manufacture enough of any potential products at an acceptable cost and with appropriate quality; - Our products may not be competitive with other existing or future products; - Proprietary rights of third parties may prevent us from commercializing our products. 11 12 IF WE FAIL TO OBTAIN ADDITIONAL FINANCING TO FUND OUR OPERATIONS, WE WILL BE UNABLE TO COMPLETE OUR PRODUCT DEVELOPMENT EFFORTS. The development of our potential drugs will require substantially more money than we currently have. That means we will have to obtain commitments for substantial funds in order to conduct the costly and time-consuming research and preclinical and clinical testing activities necessary to develop our drugs. We cannot be certain that any financing will be available when needed. If we fail to secure additional financing, as we need it, we will have to delay or terminate our drug development programs. We plan to be able to meet some of our needs for money through the sale of our interests in our affiliated businesses and we are actively pursuing several alternatives. However, those businesses are still in relatively early stages of development. We cannot be certain that these businesses will prove to be financially successful or that we will be able to sell our interest in these businesses for a substantial amount of money or at all. Even if we are successful in obtaining financing from sale of our interests in these affiliated businesses, we believe we will still need to pursue other financing opportunities to fund our research and development. Our future financing needs will depend on many factors, including the following: - scientific progress in the research and development of drug development programs; - the size and complexity of these programs; - the timing, range and results of preclinical studies and clinical trials; - our ability to establish new and maintain existing collaborations; - our ability to achieve any milestones under such collaborations; and - the time and costs involved in getting regulatory approvals or in filing, enforcing or prosecuting patents. In February, 2000, we entered into definitive purchase agreements for the sale of an aggregate 3.5 million newly issued shares of Axys Pharmaceuticals, Inc. our common stock to selected institutional and other accredited investors for $31.5 million in gross proceeds. We intend to use net proceeds from this private placement for working capital and other general corporate purposes. We expect that existing cash and investments, revenues from existing collaborations, and the net proceeds from our recently completed private placement, together with debt financing which we believe is available to us, will enable us to maintain current and planned operations for 18-24 months. We continue to actively pursue a variety of financing alternatives. The drug development process is expensive and we are at an early stage of development. Therefore, we expect that we will need to continue to raise money for a number of years until we achieve substantial product or royalty revenues, if ever. We expect that we will seek additional funding through new collaborations, the extension of existing collaborations, through sale of our interests in our affiliated businesses, or through public or private equity or debt financings. We cannot be certain that additional funding will be available or that the terms will be acceptable. Existing stockholders will experience dilution of their investment if we raise additional funds by issuing equity. If adequate funds are not available, we may delay, reduce or eliminate any of our research or development programs. Furthermore, we may obtain funds through arrangements with collaborative partners or others that require us to give up rights to technologies or products that we would otherwise seek to develop or commercialize ourselves. IF WE CONTINUE TO INCUR OPERATING LOSSES FOR LONGER THAN EXPECTED, WE MAY BE UNABLE TO CONTINUE OPERATIONS AND OUR STOCK PRICE MAY DECLINE. We may never achieve and sustain profitability. We have experienced significant operating losses since the company started. We have not generated any pharmaceutical product sales revenue. For the year ended December 31, 1999, we generated a net loss of approximately $48 million, and as of December 31, 1999, we had an accumulated deficit of approximately $277 million. We expect that we will continue to incur significant operating losses over at least the next several years as our research and development efforts and preclinical and 12 13 clinical testing activities continue. Our future profitability depends on our ability to complete product development and obtain regulatory approval for our drug candidates. If we fail to become profitable or are unable to sustain profitability on a quarterly or annual basis, we may be unable to continue operations and our stock price may decline. IF WE FAIL TO MAINTAIN OUR EXISTING COLLABORATIVE RELATIONSHIPS AND ENTER INTO NEW COLLABORATIVE RELATIONSHIPS, DEVELOPMENT OF OUR PRODUCTS COULD BE DELAYED OR WE MAY NEED TO OBTAIN OTHER SOURCES OF REVENUE. Our strategy for the development, clinical testing, manufacturing and commercialization of most of our pharmaceuticals has included entering into collaborations with corporate partners. We rely to a large extent on the activities of our collaborators with respect to the development and commercialization of our pharmaceuticals. All of our collaboration agreements may be canceled under certain circumstances. In addition, the amount and timing of resources to be devoted to research, development, eventual clinical trials and commercialization activities by our collaborators are not within our control. We cannot guarantee that our partners will perform their obligations as expected. If any of our collaborators terminate or elect to cancel their agreements or otherwise fail to conduct their collaborative activities in a timely manner, the development or commercialization of pharmaceuticals may be delayed. For example, virtually all of our genomics collaborations have been cancelled or terminated over time. If in some cases we assume responsibilities for continuing unpartnered programs after cancellation of a collaboration, we may be required to devote additional resources to product development and commercialization or we may cancel certain development programs. A large portion of our revenues to date have resulted from these collaborations. The research funding phase of most of our collaborations will come to an end in the next few years unless continued or extended by agreement with our collaborators. If our collaborations are not extended or we do not enter into additional collaborative relationships, we will have to seek other sources of revenue, including additional financing and/or sell interests in our affiliated businesses. We cannot be certain that we will receive any additional revenue from these arrangements beyond the minimum contractual commitments of our partners. We have active pharmaceutical product research and development collaborations with several different partners, including Bayer, Merck, Aventis (formerly Rhone-Poulenc Rorer) and Signal Pharmaceuticals. IF WE FAIL TO SATISFY FDA SAFETY AND EFFICACY REQUIREMENTS IN OUR CLINICAL TRIALS FOR ANY PHARMACEUTICAL, WE WILL BE UNABLE TO COMPLETE THE DEVELOPMENT AND COMMERCIALIZATION OF THAT PHARMACEUTICAL PRODUCT. Either we or our collaborators must show through preclinical studies and clinical trials that each of our pharmaceuticals is safe and effective in humans for each indication before obtaining regulatory clearance from the FDA for the commercial sale of that pharmaceutical. If we fail to adequately show the safety and effectiveness of a pharmaceutical, regulatory approval could be delayed or denied. The results from preclinical studies and early clinical trials are often different than the results that are obtained in large-scale testing. We cannot be certain that we will show sufficient safety and effectiveness in our clinical trials that would allow us to obtain the needed regulatory approval. A number of companies in the pharmaceutical industry, including biotechnology companies, have suffered significant setbacks in advanced clinical trials, even after promising results in earlier trials. Any drug is likely to produce some level of toxicity or undesirable side effects in animals and in humans when administered at sufficiently high doses and/or for a long period of time. Unacceptable toxicities or side effects may occur in the course of toxicity studies or clinical trials. If we observe unacceptable toxicities or side effects, we, our collaborators or regulatory authorities may interrupt, limit, delay or halt the development of the drug. In addition, these unacceptable toxicities or side effects could prevent approval by the FDA or foreign regulatory authorities for any or all indications. We currently have one compound, APC 2059, in clinical trials for inflammatory bowel disease. We are performing clinical trials to determine the safety and effectiveness of APC 2059 for the treatment of inflammatory bowel disease. As these clinical trials are intended to establish proof-of-principle in humans, we cannot be certain that we will be able to complete the clinical trials successfully. Our collaboration partner Bayer is moving forward with clinical development of a compound developed in our collaboration with them 13 14 for the treatment of asthma that would be taken as a pill. Phase I clinical trials are being planned to commence in the first half of 2000 to establish the safety and effectiveness of that compound in the treatment of asthma. We cannot be certain that the clinical trials of this compound will be initiated or completed successfully. Finally, we cannot be certain that any other drug candidates which may enter clinical trials will successfully complete those trials or that we or our collaborators will be able to show the safety and effectiveness of these drug candidates. IF WE FAIL TO OBTAIN REGULATORY APPROVALS TO COMMERCIALLY MANUFACTURE OR SELL ANY OF OUR PHARMACEUTICALS, OR IF APPROVAL IS DELAYED, WE WILL BE UNABLE TO GENERATE REVENUE FROM THE SALE OF OUR PRODUCTS. We must obtain regulatory approval before marketing or selling our future drug products. In the United States, we must obtain FDA approval for each drug that we intend to commercialize. The FDA approval process is lengthy and expensive, and approval is never certain. Products distributed abroad are also subject to foreign government regulation. The process of obtaining FDA and other required regulatory approvals can vary a great deal based upon the type, complexity and novelty of the products involved. Delays or rejections may be encountered based upon additional government regulation from future legislation or administrative action or changes in FDA policy during the period of clinical trials and FDA regulatory review. Similar delays also may be encountered in foreign countries. None of our drug candidates has received regulatory approval. If we fail to obtain this approval, we will be unable to commercially manufacture and sell our drug products. We have several drugs in various stages of preclinical and clinical development. These products are not expected to be available for several more years. Because of the risks and uncertainties involved in development of drug products, our drug candidates could take significantly longer to gain approval than we expect or may never gain approval. If regulatory approval is delayed, our management's credibility, the value of our company and our operating results could be adversely affected. Even if regulatory approval of a product is granted, we cannot be certain that we will be able to obtain the labeling claims necessary or desirable for the successful promotion of those products. Even if we obtain regulatory approval, we may be required to continue clinical studies even after we have started selling a pharmaceutical. In addition, identification of certain side effects after a drug is on the market or the occurrence of manufacturing problems could cause subsequent withdrawal of approval, reformulation of the drug, additional preclinical testing or clinical trials and changes in labeling of the product. This could delay or prevent us from generating revenues from the sale of that drug or cause our revenues to decline. If regulatory approval is obtained, we will also be subject to ongoing existing and future FDA regulations and guidelines and continued regulatory review. In particular, we or any third party that we use to manufacturer the drug or our collaborators will be required to adhere to regulations setting forth current good manufacturing practices. The regulations require that we manufacture our products and maintain our records in a particular way with respect to manufacturing, testing and quality control activities. Furthermore, we or our third party manufacturers or our collaborators must pass a pre-approval inspection of its manufacturing facilities by the FDA before obtaining marketing approval. Failure to comply with the FDA or other relevant regulatory requirements may subject us to administrative or legally imposed restrictions. These include: warning letters, civil penalties, injunctions, product seizure or detention, product recalls, total or partial suspension of production and FDA refusal to approve pending New Drug Applications, called NDAs, or supplements to approved NDAs. IF WE ARE UNABLE TO EFFECTIVELY PROTECT OUR INTELLECTUAL PROPERTY, WE MAY NOT BE ABLE TO COMPETE EFFECTIVELY. Our success depends in large part on our ability to obtain patents, maintain trade secrets and operate without infringing the rights of others, both in the United States and in other countries. Patents may not issue from any of our pending or future applications. Patent applications in the United States are maintained in secrecy until the patent issues. As a result, we cannot be certain that others have not filed patent applications for technology covered by our pending patent applications or that we were the first to invent the technology. In addition, an issued patent may be challenged, invalidated or maneuvered around or it 14 15 may otherwise not be sufficient to protect our technology. The patent positions of biotechnology and pharmaceutical companies can be highly uncertain and involve complex legal and factual questions. As a result, it is difficult to predict the broadness of claims allowed in biotechnology and pharmaceutical patents or their enforceability. Our commercial success also depends, in part, on not infringing patents issued to others and not breaching the technology licenses upon which any of our potential products are based. Competitors may have filed applications for, or may have received patents and may obtain additional patents and rights relating to, genes, products or processes that block or compete with ours. A number of third parties have filed patent applications or received patents in the areas of our programs. Some of these applications or patents may limit or hinder our patent applications, or conflict in certain ways with claims made under our issued patents. Furthermore, in the past we have been, and we may from time to time in the future be, notified of claims that we are infringing patents or other intellectual property rights owned by third parties. We may have to participate in interference proceedings declared by the U.S. Patent and Trademark Office. These proceedings determine the priority of invention and the right to a patent for the technology in the U.S. In addition, lawsuits may be necessary to enforce any patents issued to us or to determine the scope and validity of the rights of third parties. Lawsuits and interference proceedings, even if they are successful, are expensive to pursue, and we could use a substantial amount of our limited financial resources in either case. An adverse outcome could subject us to significant liabilities to third parties and require us to license disputed rights from third parties or to cease using such technology. It is also unclear whether our trade secrets will provide useful protection. We protect our own technology and processes, in part, by confidentiality agreements with our employees, consultants and certain contractors. However, these agreements may be disregarded or breached, and we may not have adequate remedies for any breach. In addition, it is possible that our trade secrets will otherwise become known or be independently discovered by competitors. Disputes may arise in the future with regards to the ownership of rights to any technology developed with collaborators. These and other possible disagreements with collaborators could lead to delays in the achievement of milestones or receipt of royalty payments or in research, development and commercialization of our pharmaceuticals. In addition, these disputes could require or result in lawsuits or arbitration. Lawsuits and arbitration are time-consuming and expensive. Even if we win, the cost of these proceedings could adversely affect our business, financial condition and results of operations. Furthermore, these proceedings could adversely affect our stock price or our business reputation and may make the process of entering into additional collaborative relationships more difficult. BECAUSE WE DO NOT HAVE MANUFACTURING FACILITIES FOR OUR PROPOSED DRUG PRODUCTS OR COMMERCIAL MANUFACTURING EXPERIENCE, WE COULD EXPERIENCE MANUFACTURING DELAYS OR PROBLEMS THAT HURT OUR PRODUCT SALES. We have no manufacturing facilities for our proposed drug products, and our potential products have never been commercially manufactured. We must currently rely on our collaborators, such as Bayer, Merck, and Aventis, to manufacture products created by our collaborations. We believe that our collaborators or contract manufacturers or we will be able to manufacture our compounds at a cost and in quantities necessary to make them commercially acceptable. However, we cannot be certain that this will be the case. If we or our collaborators or third party manufacturers are unable to manufacture or contract with others for a sufficient supply of our compounds on acceptable terms, we may have to delay any of the following: - our preclinical and clinical testing schedule; - our submission of products for regulatory approval; or - the market introduction and subsequent sales of products. Any of these delays would adversely affect our financial condition and results of operations. In addition to us, our collaborators and contract manufacturers must adhere to current Good Manufacturing Practices regulations enforced by the FDA through its facilities inspection program. If these facilities 15 16 cannot pass a pre-approval plant inspection, FDA approval of our products will not be granted or will be delayed. With respect to our subsidiary, Axys Advanced Technologies, we are developing new manufacturing processes to meet the expanding demand for our combinatorial chemistry libraries. We have never had to manufacture the quantities of libraries we are committed to delivering during this year. We have experienced problems in manufacturing in the past that have delayed shipments of libraries and we may experience manufacturing problems in the future as we expand our manufacturing capabilities. Problems in manufacturing could delay shipments of combinatorial chemistry compounds and this would have a material adverse effect on our financial condition and results of operations. IF WE ARE UNABLE TO ESTABLISH MARKETING AND DISTRIBUTION CAPABILITIES OR ENTER INTO ARRANGEMENTS WITH THIRD PARTIES, OUR ABILITY TO GENERATE REVENUES WILL BE HARMED. We currently have no sales, marketing or distribution capability. We will rely on our collaborative relationships, such as those with Bayer, Merck and Aventis, to market some of our future drug products. In addition, we may enter into future collaborations in which we rely on our collaborator to market our drug products. Revenues received under existing and future collaborations will depend on the success of our collaborator in marketing our drugs. We cannot be certain that collaborators will devote sufficient resources to the marketing and sale of our drugs or that the efforts of our collaborators will be successful. We may also decide to market certain of our future pharmaceuticals by ourselves. To market any pharmaceuticals ourselves, we must develop a marketing and sales force with technical expertise and the necessary supporting distribution capability. If we are unable to develop a marketing and sales force, we may be unable to effectively sell any of our pharmaceuticals. We do not know whether we will desire to or be able to establish our own sales and distribution capabilities or whether we will be able to enter into the necessary supporting relationships with third parties. IF WE FAIL TO OBTAIN AN ADEQUATE LEVEL OF REIMBURSEMENT FOR OUR DRUGS, THERE MAY BE NO COMMERCIALLY VIABLE MARKET FOR OUR PRODUCTS. The business and financial condition of pharmaceutical and biotechnology companies will continue to be affected by the efforts of outside parties, such as government health administrators, private health insurance companies and HMOs seeking to contain or reduce the cost of health care. In some foreign markets, pricing or profitability of prescription pharmaceuticals is subject to governmental control. In the United States, there have been, and we expect that there will continue to be, a number of federal and state proposals to adopt similar governmental control. In addition, an increasing emphasis on managed care in the United States has and will continue to increase the pressure on price of prescription drugs. Third-party payors are increasingly challenging the price and cost-effectiveness of medical products and services. Significant uncertainty exists as to the reimbursement status of newly approved health care products. We cannot be certain that third parties will pay for the costs of our drugs. Even if we obtain third party reimbursement, we cannot be certain that reimbursement rates will allow us to profit from the sale of our drugs. In addition, the announcement of cost containment proposals or efforts could adversely affect our ability to raise capital and our stock price. In addition, if these proposals or efforts adversely affect other pharmaceutical companies that are prospective collaborators with Axys, our ability to establish or maintain strategic alliances may be adversely affected. IF PHYSICIANS, INSURERS AND PATIENTS DO NOT ACCEPT OUR PRODUCTS, WE MAY NOT ACHIEVE SUFFICIENT REVENUE FROM SALE OF THOSE PRODUCTS. Even if our pharmaceuticals are approved for sale, we are not certain that physicians, health insurance companies or patients will accept them. If the medical community and patients do not accept our products, sales of these products will be adversely affected. The degree of market acceptance will depend upon a number of factors, including obtaining regulatory approvals, demonstrating proof in the medical community of the 16 17 clinical effectiveness and safety of our product candidates and their potential advantages over existing treatment methods and reimbursement policies of government and third-party payors. IF WE FAIL TO COMPETE SUCCESSFULLY, OUR REVENUES AND OPERATING RESULTS WILL BE ADVERSELY AFFECTED. This is a highly competitive business and many of our competitors have substantially greater resources than we have. In addition, some of these companies have considerably more experience in preclinical testing, clinical trials and other regulatory approval procedures than we have. Our competitors (including our collaborators) may develop, manufacture and market products that are more effective or less expensive than ours. They may also receive regulatory approval for their drugs faster than we can obtain them, or may commercialize their drugs more quickly than we can. Many of our competitors have greater financial and management resources than we do, and many of them have significantly more experience in bringing drugs to market. If our competitors successfully commercialize drugs to treat the indications that we are working on before we do, or if their products are less expensive or more effective than ours, demand for our drugs may suffer and our revenues may be reduced. Additionally, certain colleges and universities, governmental agencies and other research organizations are conducting research in the same areas in which we are working. These institutions are becoming increasingly aware of the commercial value of their findings and are becoming more active in seeking patent protection and licensing arrangements to collect royalties for the use of technology that they have developed. These institutions also may market competitive commercial products on their own or through joint ventures. Currently, they compete with us in recruiting highly qualified scientific personnel. IF WE FAIL TO RECRUIT AND RETAIN PROFESSIONAL STAFF, OUR PRODUCT DEVELOPMENT PROGRAMS WILL BE DELAYED. We are highly dependent on the senior members of our scientific and management staff. Retaining and attracting qualified personnel, consultants and advisors is critical to our success. If we fail to recruit and retain qualified personnel, our product development efforts will be delayed. We face intense competition for qualified individuals from numerous pharmaceutical and biotechnology companies, universities and other research institutions. We are currently seeking to hire additional qualified scientific personnel to perform research and development. In addition, we expect that we will need to add management personnel and develop additional expertise by existing management personnel in order to expand product development and clinical testing. We cannot be certain that we will be able to attract and retain such individuals on acceptable terms or at all. In addition, our academic collaborators are not our employees. As a result, we have limited control over their activities and can expect that only limited amounts of their time will be dedicated to our activities. These academic collaborators may also have relationships with other commercial entities, some of whom may compete with Axys. OUR STOCK MAY BE VOLATILE AND YOUR INVESTMENT COULD SUFFER A DECLINE IN VALUE. Stock prices and trading volumes for biotechnology companies often fluctuate widely for reasons which may be unrelated to their businesses. Our stock price could decline as a result of many factors, including: - announcements of technological innovations or new products by Axys or other companies; - developments or disputes concerning patents or other rights; - publicity regarding actual or potential medical results from products under development by Axys or other companies; - regulatory developments in both the United States and foreign countries; - public concern regarding the safety of biopharmaceutical products; - any shortfall in our revenues or net income from that expected by securities analysts; - changes in analyst's estimates of our financial performance, the financial performance or our competitors or the financial performance of biotechnology companies in general; 17 18 - sales of large blocks of our common stock; or - conditions in the financial markets or economy in general or the biotechnology industry in particular. In the past, following large price declines in the public market price of a company's securities, securities litigation has often been initiated against that company. Litigation of this type could result in substantial costs and diversion of management's attention and resources. Any adverse determination in litigation could subject us to substantial liabilities. IF PRODUCT LIABILITY CLAIMS ARE BROUGHT AGAINST US, WE MAY INCUR SUBSTANTIAL LIABILITIES. We may be exposed to liability claims resulting from the use of our products in clinical trials, or the manufacturing, marketing and sale of any approved products. These claims may be made directly by consumers, pharmaceutical companies or others. We maintain product liability insurance coverage for claims arising from the use of our products which are still in the developmental phase. However, this insurance coverage is becoming increasingly expensive. We and our collaborative partners may not be able to obtain and maintain commercially reasonable product liability insurance. Furthermore, even if we maintain insurance, the amount may not be enough to protect us against losses due to a lawsuit. A successful product liability claim against Axys or series of claims in excess of our insurance could adversely affect our results of operations and our need for additional financing. ANTI-TAKEOVER PROVISIONS UNDER DELAWARE LAW AND IN OUR CHARTER DOCUMENTS AND OUR STOCKHOLDER RIGHTS PLAN COULD MAKE AN ACQUISITION OF AXYS MORE DIFFICULT. In 1998, we adopted a stockholder rights plan, which may have the effect of delaying or preventing an unsolicited takeover of the company. Our certificate of incorporation and bylaws state that any action taken by stockholders must be conducted at an annual or special meeting of stockholders and may not be conducted by written consent. Only the board of directors, the Chairman of the Board or the President may call special meetings of the stockholders. In addition, our board of directors has the authority to issue additional shares of preferred stock and to determine the rights of those shares without any further action by the stockholders. Those rights could be senior to those of the common stockholders. The issuance of preferred stock may make it more difficult for a third party to acquire Axys. These and other charter provisions may discourage certain types of transactions involving an actual or potential change in control of Axys. In fact, these provisions may discourage transactions in which the stockholders might otherwise receive a premium for their shares over then current prices, and may limit the stockholders' ability to approve transactions that they think are in their best interests. Delaware law also prohibits corporations from engaging in a business combination with any holders of 15% or more of their capital stock until the holder has held the stock for three years unless, among other things, the board approves the transaction. Also, under Delaware law, our board of directors may adopt additional anti-takeover measures in the future. WHAT OTHER MATTERS SHOULD STOCKHOLDERS CONSIDER WITH RESPECT TO AXYS? Patents And Proprietary Rights We hold a number of issued United States patents relating to compositions of matter, methods of treating disease, combinatorial chemistry and computational technologies. These patents expire at various dates starting in year 2013 up to the year 2016. In addition, we have filed and there are now pending patent applications relating to compositions of matter, methods of treating disease, combinatorial chemistry, assay techniques, computational technologies and novel technology for the discovery of novel protease inhibitors. We intend to file additional patent applications, when appropriate, relating to our technology and to specific products we develop. We strategically file selected patent applications to protect technology, inventions and improvements that are important to the development of our business. That is our policy, as well as our practice. We also rely upon 18 19 trade secrets, know-how, continuing technological innovations and licensing opportunities to develop and maintain our competitive position. The patent positions of pharmaceutical and biotechnology firms, including Axys, are uncertain and involve complex legal and factual questions. In addition, the scope of the claims in a patent application can be significantly modified before the issued patent is issued. As a result, we do not know whether any of our applications will result in the issuance of patents, or if any of our issued patents will provide significant protection. We also do not know whether any of our issued patents will be invalidated. Since patent applications in the United States are maintained in secrecy until patents issue, and since publication of discoveries in the scientific or patent literature often lag behind actual discoveries, we cannot even be certain that we were the first creator of inventions covered by our pending patent applications or that we were the first to file patent applications for such inventions. In addition, we may have to participate in interference proceedings declared by the United States Patent and Trademark Office (PTO) to determine priority of invention. These proceedings determine the priority of invention and the right to a patent for the technology in the U.S. Such proceedings could result in substantial costs to us, even if we win. There can be no assurance that our pending patent applications, if issued, or our existing patents, will not be invalidated. An adverse outcome could subject us to significant liabilities to third parties, require disputed rights to be licensed from third parties or require us to stop or modify our use of such technology. The development of therapeutic products for applications in the product fields we are pursuing is intensely competitive. A number of pharmaceutical companies, biotechnology companies, universities and research institutions have filed patent applications or received patents in the areas in which we are conducting research. In addition, patent applications filed by others relating to our potential products or technologies may currently be pending. Some of these applications or patents may limit or hinder our freedom to practice and could result in a significant reduction of the coverage of our patents, or potential patents. We are aware of pending patent applications that have been filed by other companies that may pertain to certain of our technologies. If patents are issued to these or other companies containing incompatible or conflicting claims, and such claims are ultimately determined to be valid, we may be required to obtain licenses to these patents or to develop or obtain alternative technology. Furthermore, we have in the past been, and may again be, notified of claims that we may be infringing patents or other intellectual property rights owned by third parties. We have obtained licenses under several patents held by third parties. If necessary or desirable, we may seek additional licenses under other patents or intellectual property rights. There can be no assurance, however, that we will be able to obtain a license we seek on reasonable terms or even at all. As an alternative, we could decide to resort to litigation to challenge a patent or patents. Such challenges can be extremely expensive and time consuming. Consequently, they can have a material adverse effect on our business, financial condition and results of operations. Much of the unpatentable know-how important to our technology and many of its processes depends upon the knowledge, experience and skills of key scientific and technical personnel. To protect our rights to this know-how and technology, all employees, consultants, advisors and collaborators are required to enter into confidentiality agreements with the company that prohibits the disclosure of confidential information to any third party and requires disclosure to the company of ideas, developments, discoveries and inventions made by these individuals. There can be no assurance that these agreements will effectively prevent disclosure of our confidential information or that these agreements will provide meaningful protection for our confidential information if there is unauthorized use or disclosure. Our business could be adversely affected by competitors who develop substantially equivalent technology. In connection with certain research, we entered into sponsored research agreements with various researchers and universities. Generally, under these agreements we fund the research of investigators in exchange for the right or an option to a license to any patentable inventions that may result in designated areas. We are obligated to make certain payments during the terms of certain of the agreements, to pay royalties on net sales of any licensed products and, in some cases, to negotiate in good faith the business terms 19 20 of any license executed upon exercise of licensing options. There can be no assurance that these agreements will not be breached or that we would have adequate remedies for any breach. Government Regulation The manufacturing and marketing of our proposed products and our research and development activities are subject to regulation for safety, effectiveness and quality by many governmental authorities in the United States and other countries. In the United States, drugs are subject to stringent regulation by the United States Food and Drug Administration (FDA). The Federal Food, Drug and Cosmetic Act and FDA regulations, as well as other federal and state laws and regulations, govern, the testing, manufacture, safety, effectiveness, package labeling, storage, record keeping, approval, advertising and promotion of our proposed products. Product development and approval takes a long time and involves the expenditure of a lot of money. If we fail to comply with certain regulatory requirements, we could be subject to sanctions, such as warning letters, penalties, criminal prosecution, injunctions, product seizure, product recalls, total or partial suspension of production, and FDA refusal to approve pending New Drug Applications (NDA) or costly supplements to approved applications. The steps required before a drug may be marketed in the United States include (i) preclinical laboratory tests, in vivo (animal model) preclinical studies and formulation studies, (ii) the submission to the FDA of an application for human clinical testing, known as an Investigational New Drug Application (IND), which must be accepted by the FDA before human clinical trials are started, (iii) adequate and well-controlled human clinical trials to establish the safety and effectiveness of the drug, (iv) the submission of an NDA to the FDA, and (v) FDA approval of the NDA prior to any commercial sale or shipment of the drug. In addition to obtaining FDA approval for each product, each domestic drug manufacturing establishment must be registered with the FDA. Domestic drug manufacturing establishments are subject to inspections twice a year by the FDA and must comply with Good Manufacturing Practices. To supply products for use in the United States, foreign manufacturers must comply with Good Manufacturing Practices and are subject to periodic inspection by the FDA or by corresponding regulatory agencies in their country. Drug product manufacturers located in California also must be licensed by the State of California. Preclinical tests include laboratory evaluation of what is in the product and how it was made, as well as animal studies to assess the potential safety and effectiveness of the product. Preclinical safety tests must be conducted by laboratories that comply with FDA regulations regarding Good Laboratory Practices. The results of the preclinical tests are submitted to the FDA as part of an IND and reviewed by the FDA prior to the start of human clinical trials. Unless the FDA objects, the IND will become effective 30 days following its receipt by the FDA. There can be no assurance that submission of an IND will result in FDA authorization to start clinical trials. Clinical trials involve the giving the investigational new drug to healthy volunteers and to patients, under the supervision of qualified investigators. Clinical trials are conducted in agreement with Good Clinical Practices under instructions that detail the objectives of the study, the limits to be used to monitor safety and the effectiveness criteria to be evaluated. Instructions must be submitted to the FDA as part of the IND. Further, each clinical study must be conducted under the power of an independent Institutional Review Board ("IRB") at the site where the study will be conducted. The IRB will consider, among other things, ethical factors, the safety of human subjects and the possible liability of the site. Clinical trials are typically conducted in three phases that go in order, but the phases may overlap. In Phase I, in which we usually give the drug to healthy subjects, the drug is tested to determine its metabolism (how the drug is absorbed by the body), pharmacokinetics (what the body does to the drug) and pharmacological actions (biological effects) in humans, the side effects associated with increasing doses and early evidence of how effective the drug is, if possible. Phase II involves studies in a limited patient population to (i) determine the effectiveness of the drug for specific, targeted indications, (ii) determine what amount of the drug works best and how much of the drug can be tolerated, and (iii) identify possible adverse effects and safety risks. If a compound is found to be effective and to have an acceptable safety profile in Phase II evaluations, Phase III trials further evaluate the effectiveness of the drug and further test for safety in a larger group of people at many different locations. 20 21 There can be no assurance that Phase I, Phase II or Phase III testing will be completed successfully within any specific time period, if at all, for any of our proposed products. Furthermore, the FDA or we may suspend or cancel clinical trials at any time if it is felt that the patients are being exposed to an unacceptable health risk or the FDA finds errors or incorrect information in the IND or due to the conduct of the investigation. Further, FDA regulations state that sponsors of clinical investigations must meet numerous regulatory requirements, including, selection of qualified investigators, proper monitoring of the investigations, recordkeeping and record retention, and ensuring that FDA and all investigators are promptly informed of significant new adverse effects or risks with respect to the drug. The results of the drug development, preclinical studies and clinical studies are submitted to the FDA in the form of an NDA, which, if accepted, would clear the way for marketing and commercial shipment of the drug. There can be no assurance that any approval will be granted by the FDA at all or, if granted, will be granted on a timely basis. The FDA may deny an NDA if certain regulatory criteria are not satisfied, may require additional testing or information, or may require post-marketing testing and surveillance to monitor the safety of our products if the FDA does not view the NDA as containing enough evidence of the safety and effectiveness of the drug. Even if the company submits additional data, the FDA may still decide that the application does not satisfy its regulatory criteria for approval. In addition, even if regulatory clearance of a drug is granted, such approval may limit the uses for which it may be marketed. Finally, product approvals may be taken away if regulatory standards are not maintained or if problems occur following initial marketing. Among the typical conditions for NDA approval is the requirement that the proposed manufacturer's quality control and manufacturing procedures conform to Good Manufacturing Practices, which must be followed at all times. To comply with these standards, we will have to spend a large amount of time, money and effort in the area of production and quality control to ensure full technical compliance. In addition to regulations enforced by the FDA, we will also be subject to regulation under the Occupational Safety and Health Act, the Environmental Protection Act, the Toxic Substances Control Act, the Resource Conservation and Recovery Act and other present and potential future federal, state or local regulations. Our research and development involves the controlled use of hazardous materials, chemicals and various radioactive compounds, all of which are regulated. Although we believe that our safety procedures for handling and disposing of these materials comply with the standards set by state and federal regulations, the risk of accidental contamination or injury from these materials is possible. In the event of an accident, the company could be held sued for any damages that result and any such lawsuit could exceed the insurance and resources of the company. For clinical investigation and marketing outside the United States, we are also subject to foreign regulatory requirements governing human clinical trials and marketing approval for drugs. These requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement vary widely for European countries both within, and outside, the European Union (EU). We plan to comply with the European regulatory process by identifying and using clinical investigators in the member states of the EU and other European countries to conduct clinical studies. Further, we intend to design our studies to meet FDA, EU and other European countries' standards. Within the EU, while marketing authorizations must be supported by clinical trial data of a type and to the extent set out by EU directives and guidelines, the approval process for the commencement of clinical trials is not currently harmonized by EU law and varies from country to country. As far as possible, we intend to design our studies so as to develop a regulatory package sufficient for multi-country approval in our European target markets, without the need to duplicate studies for individual country approvals. Outside the United States, our ability to market a product is based upon receiving a marketing authorization from the appropriate regulatory authority. Currently, foreign marketing authorizations are applied for at a national level, although within the EU certain registration procedures are available to companies wishing to market the product in more than one EU member state. If the regulatory authority is satisfied that enough evidence of safety, quality and effectiveness has been presented, a marketing authorization will be granted. The system for obtaining marketing authorizations within the EU changed on January 1, 1995. The current EU registration system is a dual one in which certain products, such as biotechnology and 21 22 high technology products and those containing new active substances, will have access to a central regulatory system that provides registration throughout the entire EU. Other products will be registered by national authorities in individual EU member states, operating on a principle of mutual recognition. This foreign regulatory approval process includes all of the same risks involved in the FDA approval process described above. Employees As of December 31, 1999, we employed 298 individuals, of whom 102 hold Ph.D. or M.D. degrees and 132 hold other advanced degrees. Approximately 251 of our employees are involved in research and development activities, including a variety of disciplines within the areas of molecular biology and other biological sciences, medicinal chemistry, genomics and genetics, bioinformatics, computer sciences pharmacology, safety assessment and clinical development. Approximately 47 of our employees are employed in finance, corporate development and general administrative activities. None of our employees are covered by collective bargaining agreements, and our management considers relations with its employees to be good. We also enters into part-time consulting arrangements with experienced, professional scientists and managers to supplement our work force.
R&D G&A TOTAL --- --- ----- Drug Discovery.......................................... 155 33 188 AAT..................................................... 57 6 63 PPGx.................................................... 39 8 47 --- -- --- Total......................................... 251 47 298 === == ===
ITEM 2. PROPERTIES We currently lease approximately 230,000 square feet and occupy approximately 151,000 square feet of laboratory, support and administrative space in South San Francisco and La Jolla, California, of which AAT occupies approximately 29,000 square feet in South San Francisco. Leases expire on these facilities on December 31, 2001 with respect to approximately 60,056 square feet, November 30, 2002 with respect to the approximately 13,600 square feet, November 30, 2003 with regard to 52,200 square feet, July 31, 2005 with respect to 32,700 square feet and August 4, 2006 for the remainder of the our facilities. Most of these leases have additional options for extensions. In addition in 1999, the Company entered into a lease for an adjacent warehouse building through May 2006 which is convertible into a ground lease for 25 years with options to extend for two additional 10-year periods. We are considering whether to convert this lease into a ground lease and building a new medicinal chemistry building on the property. We are subleasing approximately 80,000 square feet under four sublease agreements, with the leases and subleases expiring through July 31, 2005. Our existing and planned facilities are believed to be adequate to meet our present requirements, and we currently believes that suitable additional space will be available to us, when needed, on commercially reasonable terms. ITEM 3. LEGAL PROCEEDINGS From time to time we are subject to legal proceedings or claims arising in the ordinary course of its business. While the outcome of any such proceedings or claims cannot be predicted with certainty, our management does not believe that the outcome of any of these legal matters will have a material adverse effect on our consolidated results of operations or consolidated financial position. ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS During the fourth quarter of 1999, no matters were submitted to a vote of the stockholders. 22 23 EXECUTIVE OFFICERS OF THE REGISTRANT Listed below is biographical information on executive officers of Axys as of February 18, 2000.
NAME AGE POSITION WITH AXYS ---- --- ------------------ John P. Walker.................... 51 Chairman, Chief Executive Officer and Director Michael C. Venuti, Ph.D........... 46 Senior Vice President, Preclinical Development, Chief Technical Officer Daniel F. Hoth, M.D............... 54 Senior Vice President, Chief Medical Officer Kathleen Stafford................. 42 Senior Vice President, Chief Financial Officer William J. Newell, J.D............ 42 Senior Vice President, Corporate and Business Development, General Counsel and Secretary
JOHN P. WALKER Mr. Walker has been Chief Executive Officer and a director of Axys since 1993 and was appointed Chairman of the Board in January 1998. From 1993 to January 1998, he was also President of the company. Prior to joining Axys, Mr. Walker was the Chairman and Chief Executive Officer of Vitaphore Corporation, a medical device company which was sold to Union Carbide in 1990, and for a period of 15 years was an executive with American Hospital Supply Corporation, most recently having served as President of the Hospital Company. Mr. Walker also serves as Chairman of Signal Pharmaceuticals, Inc. and Microcide Corporation and is on the board of directors of Geron Corporation and the Biotechnology Industry Organization. Mr. Walker received a B.A. degree from the State University of New York at Buffalo and conducted graduate business studies at Northwestern University Institute of Management. MICHAEL C. VENUTI, PH.D. Dr. Venuti has been Axys' Senior Vice President, Research and Preclinical Development since November 1998, and had previously served as Senior Vice President, Research, South San Francisco, Vice President, Research and Chief Technical Officer since January 1998, February 1997 and July 1996, respectively. Dr. Venuti joined Axys in November 1994 as Director of Chemistry and was promoted to Vice President of Chemistry in July 1995, where he served until February 1997. From 1993 until he joined Axys, he was at Parnassus Pharmaceuticals, a start-up biotechnology company where he was Vice President, Chief Scientific Officer and a founder. From 1988 to 1993, Dr. Venuti was at Genentech, Inc., a biotechnology company, where he was Director of Bioorganic Chemistry, a program that he helped establish. From 1979 to 1988, Dr. Venuti was employed at Syntex as a chemistry group leader. Dr. Venuti received an A.B. in chemistry from Dartmouth College, a Ph.D. in organic chemistry from the Massachusetts Institute of Technology and was a postdoctoral fellow at the Syntex Institute of Organic Chemistry. DANIEL F. HOTH, M.D. Dr. Hoth joined Axys in June 1999 as Senior Vice President and Chief Medical Officer. Prior to joining Axys, Dr. Hoth was principal of an independent consulting practice to pharmaceutical and life science firms, and the National Institute of Health. Previously, from 1993 to 1997, Dr. Hoth served as Senior Vice President and Chief Medical Officer at Cell Genesys, where he was responsible for trials of gene therapy in cancer and HIV. From 1987 to 1993, he was Director, Division of Acquired Immunodeficiency Syndrome at the National Institute of Health (NIH), heading all activities under the NIAID's AIDS program. Dr. Hoth's tenure at the National Cancer Institute (1980 to 1987) included Chief of the Investigational Drug Branch, as well as the head of the Cancer Therapy Evaluation Program. Dr. Hoth also served as an instructor and Assistant Professor of Medicine at Georgetown University School of Medicine. He received his medical degree at Georgetown University School of Medicine, and completed his fellowship in medical oncology at Georgetown University Hospital. 23 24 KATHLEEN STAFFORD Kathleen Stafford joined Axys as Senior Vice President and Chief Financial Officer in September 1999. Prior to joining the company, Ms. Stafford was a consultant to various companies in the biotechnology industry. From early 1995 to the end of 1997, she was the Vice President and Chief Financial Officer of CV Therapeutics. From early 1994 to late 1994 Ms. Stafford was Chief Financial Officer of Onyx Pharmaceuticals. Ms. Stafford was Treasurer of Amgen from 1989 to early 1994. She received her M.B.A. degree from Virginia Polytechnic Institute, and her B.S. degree in combined science from Santa Clara University. She is a director of the Children's Hospital Oakland Research Institute. WILLIAM J. NEWELL, J.D. Mr. Newell is Senior Vice President, Corporate and Business Development, General Counsel and Secretary. He originally joined Axys as Vice President and General Counsel in July 1998. From October 1983 to July 1998, Mr. Newell practiced at the firm of McCutchen, Doyle, Brown & Emerson, LLP (Palo Alto Office) where he had been a partner since 1990. He received his J.D. from the University of Michigan Law School and holds an A.B. from Dartmouth College. PART II. ITEM 5. MARKET FOR REGISTRANT'S COMMON STOCK AND RELATED STOCKHOLDER MATTERS Axys' Common Stock began trading on the Nasdaq National Market on November 19, 1993. Prior to that date, there was no public market for the Company's Common Stock. The company's current ticker symbol is "AXPH". The following table sets forth, for the periods indicated, the high and low sales prices of the Common Stock reported on the Nasdaq National Market. These over-the-counter quotations reflect inter-dealer prices, without retail markup, markdown or commission, and may not necessarily represent the sales prices in actual transactions.
HIGH LOW ------ ----- 1998 First Quarter............................................... $10.75 $7.66 Second Quarter.............................................. 8.75 6.50 Third Quarter............................................... 7.75 3.38 Fourth Quarter.............................................. 7.06 3.69 1999 First Quarter............................................... $ 8.13 $3.75 Second Quarter.............................................. 4.50 3.00 Third Quarter............................................... 4.97 3.56 Fourth Quarter.............................................. 4.96 2.69
On February 29, 2000, the last sale price reported on the Nasdaq National Market for the Company's Common Stock was $16.00 per share. HOLDERS As of February 29, 2000 there were approximately 565 stockholders of record of the Company's Common Stock. DIVIDENDS The Company has not paid dividends on its Common Stock and currently does not plan to pay any cash dividends in the foreseeable future. 24 25 RECENT SALES OF UNREGISTERED SECURITIES On October 6, 1999 Axys issued 231 shares of Common Stock, valued at $822.36 to Kleiner Perkins Caufield Byers VI, in connection with the net issuance exercise of a warrant. In July 1999 Axys issued a warrant to purchase 50,000 shares of Common Stock at $4.06 per share to Reedland Capital. The warrant expires July 30, 2004. The issuance and sale of such shares was intended to be exempt from registration and prospectus delivery requirements under the Securities Act of 1933, as amended (the "Securities Act"), by virtue of Section 4(2) thereof due to, among other things, (i) the limited number of persons to whom the shares were issued, (ii) the distribution of disclosure documents to the investor, (iii) the fact that such person represented and warranted to the Company, among other things, that such person was acquiring the shares for investment only and not with a view to the resale or distribution thereof, and (iv) the fact that certificates representing the shares were issued with a legend to the effect that such shares had not been registered under the Securities Act or any state securities laws and could not be sold or transferred in the absence of such registration or an exemption therefrom. 25 26 ITEM 6. SELECTED FINANCIAL DATA AXYS PHARMACEUTICALS, INC. The data should be read in conjunction with "Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations" and "Item 8. Financial Statements and Supplementary Data" which is included elsewhere in this Annual Report on Form 10-K.
YEAR ENDED DECEMBER 31, ---------------------------------------------------------- 1995(1) 1996 1997 1998(2) 1999 -------- -------- -------- --------- --------- (IN THOUSANDS, EXCEPT PER SHARE AMOUNTS) CONSOLIDATED STATEMENTS OF OPERATIONS: Revenues.......................... $ 16,727 $ 21,560 $ 24,814 $ 47,422 $ 38,257 Operating costs and expenses: Cost of goods sold.............. -- -- 1,010 2,058 2,698 Research and development........ 14,689 24,319 30,040 62,176 65,504 General and administrative...... 4,247 5,409 7,153 14,460 14,093 Restructuring charge............ -- -- -- -- 5,175 Acquired in-process research and development.................. 22,514 230 -- 124,888 -- -------- -------- -------- --------- --------- Total operating costs and expenses........................ 41,450 29,958 38,203 203,582 87,470 -------- -------- -------- --------- --------- Operating loss.................... (24,723) (8,398) (13,389) (156,160) (49,213) Interest income (expense), net.... 990 2,470 2,422 2,317 260 Equity interest in loss of joint venture......................... -- -- -- (2,393) (836) Minority interest................. -- -- -- 112 1,879 Other income/expense, net......... -- -- -- -- (853) -------- -------- -------- --------- --------- Net loss.......................... $(23,733) $ (5,928) $(10,967) $(156,124) $ (48,763) ======== ======== ======== ========= ========= Net loss per share, basic and diluted......................... $ (2.71) $ (0.45) $ (0.73) $ (5.25) $ (1.60) Weighted average number of shares used in computing basic and diluted net loss per share...... 8,745 13,177 15,025 29,758 30,385
DECEMBER 31, ---------------------------------------------------------- 1995(1) 1996 1997 1998 1999 -------- -------- -------- --------- --------- (IN THOUSANDS) CONSOLIDATED BALANCE SHEET DATA: Cash, cash equivalents and marketable investments.......... $ 31,105 $ 66,720 $ 53,408 $ 72,717 $ 26,657 Total assets...................... 40,293 80,832 73,584 107,262 55,734 Long-term obligations............. 16,490 10,676 15,331 16,816 57 Accumulated deficit............... (56,876) (62,804) (73,771) (229,895) (277,211) Total stockholders' equity........ 7,278 52,900 43,890 60,512 14,047
- --------------- (1) Includes the results of operations of Khepri Pharmaceuticals, Inc. from December 22, 1995 through December 31, 1995, including a one-time charge for acquired in-process research and development. Excluding such one-time charge, net loss and net loss per share would have been $1,219,000 and $0.14 per share, respectively. (2) Includes the results of operations of Sequana Therapeutics, Inc. from January 8, 1998 through December 31, 1998, including a one-time charge for acquired in-process research and development. Excluding such one-time charge, net loss and net loss per share would have been $31,236,000 and $1.05 per share, respectively. 26 27 ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS The following discussion contains both historical information and forward-looking statements that involve risks and uncertainties. Forward-looking statements include projections and other statements of events that may occur at some point in the future. The company's actual results could differ significantly from those described in the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in this section as well as under "Item 1. Business," including, "What Factors Could Cause Our Results To Differ Significantly From Those You Might Expect?" and "What Other Matters Should Stockholders Consider with Respect to the Company?" OVERVIEW We are an early-stage biopharmaceutical company focused on the discovery, development and commercialization of small molecules. We invest our own resources on discovering and developing therapeutics for the treatment of various types of cancer and we collaborate with large pharmaceutical companies in discovering therapeutics for chronic diseases for which there are large markets. We have three affiliated companies that were formed to provide capital to Axys for our drug discovery operations: - Axys Advanced Technologies (AAT), which began operations in 1996 and set up as a wholly owned subsidiary in 1999 is a 100% owned subsidiary that markets combinatorial chemistry compounds, enabling technology and services. It has been profitable since inception. Financial results of AAT are 100% consolidated into Axys' financial results. - Akkadix Corporation (Akkadix), an agricultural biotechnology company founded in 1998 is 38% owned by Axys. It has incurred losses since inception. Akkadix is separately managed and is funded by third parties. Akkadix financial results were consolidated into Axys financial results though August 1999. In September 1999 Axys' ownership in Akkadix reduced to below 50%. As a result, Akkadix is now accounted for under the equity method. - PPGx, Inc. (PPGx), a pharmacogenomics subsidiary founded in 1999, is 82% owned by Axys and 17.5% owned by PPD, Inc. Financial results of PPGx are consolidated into Axys' financial results. It has incurred losses since inception, is separately managed and is funded by third parties. To date, we have not generated any product revenue in its drug discovery programs and do not expect to generate such revenues for at least several years. As of December 31, 1999, we had an accumulated deficit of $277 million. We expect our sources of revenue, if any, for the next several years to consist of payments under corporate partnerships, interest income and sales made by our AAT subsidiary. The process of developing our products will require significant additional research and development, preclinical testing and clinical trials, as well as regulatory approval. These activities, together with our general and administrative expenses are expected to result in significant operating losses for the foreseeable future. Axys will not receive product revenue or royalties in our drug discovery programs unless our collaborative partners complete clinical trials and successfully commercialize one or more of our products. In addition, there can be no assurance that AAT will remain profitable, or that Akkadix or PPGx will ever provide funding for our drug discovery operations. We are subject to risks common to early-stage drug discovery and development companies, including risks inherent in our research and development efforts and clinical trials, reliance on collaborative partners, enforcement of patent and proprietary rights, the need for future capital, potential competition and uncertainty of regulatory approval. In order for a product to be commercialized, it will be necessary for us, and in some programs, our collaborators, to conduct preclinical tests and clinical trials to demonstrate efficacy and safety of our product candidates, obtain regulatory clearances and enter into manufacturing, distribution and marketing arrangements as well as obtain market acceptance. There can be no assurance that we will generate revenues or achieve and sustain profitability in the future. 27 28 RESULTS OF OPERATIONS YEARS ENDED DECEMBER 31, 1999 AND 1998 1999 Events Which Affected the Company's Operations: In December 1999 we completed the closing of our La Jolla, CA operations and relocated our oncology genomics activities to our South San Francisco headquarters. As a result of this action, a one-time restructure charge of $5.2 million was taken in 1999. In September 1999, Akkadix Corporation ("Akkadix"), (formerly known as Xyris Corporation) completed its acquisition of Global Agro, Inc. ("Global"). As a result of this acquisition, the company's interest in Akkadix fell below 50% and Akkadix will now be accounted for under the equity method. In February 1999, we formed a majority owned subsidiary, PPGx, Inc. ("PPGx") which is engaged in the business of providing pharmacogenomic (the science of how genetic variations among individuals affects drug safety and efficacy) products and services to the pharmaceutical industry. In connection with the formation of PPGx, Axys contributed certain assets and technology in exchange for an 82% ownership interest in PPGx. PPD, Inc. ("PPD"), Axys' partner in PPGx, contributed certain assets, technology, cash and loan guarantees in exchange for an 18% ownership interest in PPGx and the exclusive, worldwide right to market the pharmacogenomic products and services of PPGx. Our collaborative research programs generally contain one or more of the following sources of revenue to us: - Research Support: Payments that are generally based on the number of researchers Axys is committing to a particular program. These revenues are recorded when earned through the performance of the required research by Axys. - License Fees: Payments that are generally received when the collaboration agreement is signed. These revenues are amortized over the term of the agreement. - Commitment Fees: Payments that are generally received in conjunction with our commitment to perform certain funded research. These revenues are recorded over the course of the research efforts. - Milestone Payments: Payments that are based on our or our partner achieving certain technical or regulatory milestones in the collaboration. These revenues are recorded upon the achievement of mutually agreed upon milestones. - Premiums paid on Equity Investments: Premiums paid in excess of the fair market value of the Company's stock is recognized as revenue over the research period. Our sales of chemical compound libraries contain one or more of the following sources of revenue to us: - Product Sales: As chemical compound libraries are shipped to customers of AAT, we record revenue based on the contracted price per compound. - License Fees: Payments that are generally received when compound supply or technology license agreements are signed. These revenues are recognized over the term of the agreement. - Commitment Fees: Payments that are received in conjunction with AAT's commitment to perform certain obligations under compound supply or technology license agreements. These revenues are recorded over the course of the relevant agreement, as performance obligations are completed. - Protocol Fees: Payments that are received in exchange for technology know-how. These revenues are recorded as protocols are delivered. We have not been profitable since inception and expects to incur substantial losses for at least the next several years, primarily due to the cost of its research and development programs, including preclinical studies and human clinical trials. We expect that losses will fluctuate from quarter to quarter, that such fluctuations may be substantial, and that results from prior quarters may not be indicative of future operating results. As of 28 29 December 31, 1999, our accumulated deficit was approximately $277 million. Included in our accumulated deficit at December 31, 1999 was approximately $147 million of acquired in-process research and development from the acquisition of Khepri Pharmaceuticals, Inc. in 1995 and the acquisition of Sequana in January 1998. REVENUES Collaboration and licensing revenues Our collaboration and licensing revenues decreased to $25.3 million for the year ended December 31, 1999, from $38.9 million in 1998. Collaboration and licensing revenues (which generally consist of research support and license fees), for the year ended December 31, 1999 were attributable to the collaborative research agreements with: (i) Parke-Davis for the gene identification program in schizophrenia and bipolar disorder; (ii) Aventis for the development of small molecule therapeutics that inhibit cathepsin S, associated with certain inflammatory diseases, (iii) Bristol-Myers Squibb for the development of small molecule inhibitors of proteases involved in hepatitis C virus infection; and (iv) Merck for the development of small molecule inhibitors of proteases involved in osteoporosis. 1999 revenues decreased when compared to 1998 due to lower revenues recognized under the following agreements: (i) the end of research support in June 1999 under the Boehringer Ingelheim International GmbH agreement for the gene identification program in asthma; (ii) the winding-down of the Parke-Davis gene identification program for schizophrenia and bipolar disorder; and (iii) the end of research funding in mid 1998 of the Pharmacia & Upjohn agreement for the development of inhibitors of Factor Xa. As Axys has shifted its focus to proprietary oncology programs, collaboration and licensing revenues are expected to continue to decline. Product revenues Our product revenues increased to $12.9 million for the year ended December 31, 1999, from $8.5 million in 1998. The increase was primarily due to the overall increase in compound libraries shipped in 1999, when compared to 1998, in accordance with the terms of the combinatorial chemistry agreements with Pharmacia & Upjohn, Parke-Davis, Aventis, Daiichi, Allergan, as well as with other smaller biotechnology companies. PPGx accounted for approximately $890,000 of product revenue in 1999. Cost of Goods Sold Our cost of goods sold increased to $2.7 million for the year ended December 31, 1999 from $2.1 million in 1998. The increase was primarily due to more compound libraries shipped in 1999 than 1998 under the combinatorial chemistry agreements. Cost of goods has a direct relationship to product revenues. Research and Development Our research and development expenses increased to $65.5 million for the year ended December 31, 1999, from $62.2 million in 1998. The increase was primarily due to research and development expenses related to Axys' affiliates PPGx and Akkadix, which are not funded by Axys, as indicated in the table below. Another contributing factor to the increase was the reduction of approximately 36 individuals in the first quarter of 1999, with an associated severance cost of approximately $413,000. Akkadix' activities are reflected in the consolidated results of the company through the date of its merger with Global Agro, which means through the first eight months of 1999.
OTHER DRUG AFFILIATED DISCOVERY AAT BUSINESSES TOTAL --------- ----- ---------- ----- Year ended 1999................................ $54.1 $ 5.1 $ 6.3 $65.5 Year ended 1998................................ 57.3 4.9 0.0 62.2 ----- ----- ----- ----- (Increase)/Decrease............................ $ 3.2 $(0.2) $(6.3) $(3.3) ===== ===== ===== =====
29 30 When we acquired Sequana in January 1998, Sequana had the following research programs in progress: Asthma, partnered with Boehringer Ingelheim Int'l GmbH; Osteoporosis, partnered with Corange International Ltd.; Non-Insulin Dependent Diabetes Mellitus (NIDDM), partnered with Glaxo Wellcome, Inc.; Schizophrenia/Bipolar, partnered with Parke-Davis Pharmaceutical Research division of Warner-Lambert Company; Obesity, Alzheimer's and Pharmacogenomics. As of December 31, 1999 the Schizophrenia/Bipolar program was transferred to Parke-Davis and the Pharmacogenomics program was spun off into the PPGx subsidiary with PPD. All other programs have ended. GENERAL AND ADMINISTRATIVE Our general and administrative expenses decreased to $14.1 million for the year ended December 31, 1999, from $14.5 million in 1998. Decreases were primarily due to lower expenses as a result of the winding down of activities in our La Jolla operation. These decreases were offset by the addition of administrative expenses of our newly formed affiliates, PPGx and Akkadix, not funded by Axys.
OTHER DRUG AFFILIATED DISCOVERY AAT BUSINESSES TOTAL --------- ----- ---------- ----- Year ended 1999................................ $10.1 $ 1.5 $ 2.5 $14.1 Year ended 1998................................ 13.1 0.8 0.6 14.5 ----- ----- ----- ----- (Increase)/Decrease............................ $ 3.0 $(0.7) $(1.9) $ 0.4 ===== ===== ===== =====
Interest Income and Interest Expense Interest income decreased to $2.3 million for the year ended December 31, 1999, from $4.7 million in 1998. The decrease was primarily due to the decrease in average cash and investment balances between the periods. Interest expense decreased to $2.1 million for the year ended December 31, 1999, from $2.4 in 1998. The decrease was primarily due to the lower debt balances from our lines of credit and existing leasing arrangements. Equity Interest in Loss of Joint Venture Equity interest in loss of joint venture decreased to $0.8 million for the year ended December 31, 1999 as compared to $2.4 million in 1998 and was due to the decrease in the loss for Genos. This amount represents Axys' 50% portion of Genos' loss for 1999 based on our 50% ownership of Genos. The decrease is primarily due to the winding down of operations of Genos since May 1999. In the third quarter of 1999, we wrote off the balance of the investment in Genos. Minority Interest Minority interest represents another investor's share of a subsidiary's operating income (loss), where the company owns 51% to 99% of that subsidiary. Minority interest increased to $1.9 million for the year ended December 1999, from $112,000 in 1998. This amount is the result of the formation of the Company's majority owned subsidiary, PPGx, in 1999 and Akkadix, in 1998. Since we report all of PPGx's expenses as our expenses (see "General and Administrative" above), this one line allocates a portion of PPGx's loss to the minority shareholders, and reduces our operating loss. Restructuring Charge In December 1999, we completed the closing of our La Jolla, CA operations and relocated our oncology genomics activities to its South San Francisco headquarters. As a result of this action, a one-time charge of $7.0 million was taken during the third quarter, of which $2.2 million related to severance and other employee-related costs, $1.7 million related to facilities costs, $1.8 million related to the disposal of assets, and $1.3 in other costs associated with the restructuring. In the fourth quarter the restructure charge was reduced by $1.8 million, to $5.2 million due to a change in estimates resulting from the additional subleases of the La Jolla facility we leased, and for better than expected proceeds from the disposal of equipment and other assets 30 31 associated with closing down the La Jolla facility. The facilities costs included lease payments on facilities vacated in La Jolla net of proceeds from existing subleases. As a result of closing the facility, we eliminated 120 positions of which 93 are included in the severance calculation and 27 positions were eliminated through attrition and cancellation of open requisitions. At December 31, 1999, the only remaining accrual relating to the restructuring was approximately $1.9 million which will be utilized through December 31, 2001. Other Income/Expense Other Income and Expense represents primarily the write-off of Axys' 50% interest in Genos, a joint venture with Memorial Sloan Kettering Cancer Center, totaling $1.1 million. YEARS ENDED DECEMBER 31, 1998 AND 1997 1998 Events Which Affected The Company's Operations: On January 8, 1998 we completed the acquisition of Sequana Therapeutics, Inc. ("Sequana"), a genomics company of approximately 200 employees based in La Jolla, California. We acquired all of the outstanding stock of Sequana in exchange for Axys common stock. In general, Sequana was a company of similar size and complexity to Axys. Sequana's revenues were primarily derived from collaborative research agreements with most of the same components as those described above for Axys. Consequently, in comparing the operating results of the company for the periods ended December 31, 1998 and 1997, Sequana contributed in large part to the doubling of all of the line items on the Statement of Operations, except "Product Revenues" and "Cost of Goods Sold," which were applicable to of Axys alone. REVENUES Collaboration and licensing revenues Our collaboration and licensing revenues increased to $38.9 million for the year ended December 31, 1998, from $22.5 million in 1997, primarily due to the acquisition Sequana. If the acquisition had occurred prior to 1997, revenues on a pro forma basis for 1997 would have been $42.1 million, and would have therefore been $3.2 million lower in 1998. Collaboration and licensing revenues for the year ended December 31, 1998 were attributable to the material collaborative research agreements with: (i) Parke-Davis for the gene identification program in schizophrenia and bipolar disorder, and includes research funding; (ii) Boehringer Ingelheim for the gene identification program in asthma, and include research funding; (iii) Bristol-Myers Squibb for the development of small molecule inhibitors of proteases involved in hepatitis C virus infection and include research funding, as well as a licensing fee; (iv) Merck for the development of small molecule inhibitors of proteases involved in osteoporosis, and include research funding and the amortization of an up-front licensing fee; and (v) Aventis for the development of small molecule therapeutics that inhibit cathepsin S, associated with certain inflammatory diseases, and include a licensing fee. Although some of these agreements were new, 1998 revenues decreased when compared to 1997 on a pro forma basis because of lower revenues recognized under the following agreements: (i) the end of research funding in July 1998 of the Pharmacia & Upjohn agreement for the development of inhibitors of Factor Xa; (ii) the end of the research phase in November 1997 of the Bayer agreement to develop inhibitors of the regulatory enzymes tryptase and chymase for the treatment of asthma; (iii) the termination of the Glaxo agreement for the genomics work in the area of type II diabetes and related conditions; and (iv) the end of the research phase of the SmithKline Beechum agreement in December 1997 for the inhibition of intracellular viral proteases. Product revenues Our product revenues increased to $8.5 million for the year ended December 31, 1998, from $2.3 million in 1997. The increase was primarily due to the overall increase in compound libraries shipped in 1998, when compared to 1997, in accordance with the terms of the combinatorial chemistry agreements with Pharmacia & Upjohn, Parke-Davis and Rhone-Poulenc Rorer. 31 32 Cost of Goods Sold Our cost of goods sold increased to $2.1 million for the year ended December 31, 1998 from $1.0 million in 1997. The increase was primarily due to more compound libraries being shipped in 1998 than 1997 under the three agreements discussed above. Research and Development Our research and development expenses increased to $62.2 million for the year ended December 31, 1998, from $30.0 million in 1997, primarily due to the acquisition of Sequana and additional costs associated with the clinical trials of APC-366, prior to the termination of that program. If the acquisition of Sequana had occurred prior to 1997, research and development expenses would have been $59.9 million in 1997 on a pro forma basis. The increase on a pro forma basis to $62.2 million in 1998 from $59.9 million in 1997 was due to the increase in clinical trial costs discussed above, as well as the expanded research efforts in drug discovery. General and Administrative Our general and administrative expenses increased to $14.5 million for the year ended December 31, 1998, from $7.2 million in 1997, primarily due to the Sequana acquisition and the planning of our strategic initiative in oncology. Additionally, general and administrative expenses for 1998 included all of the expenses of our subsidiary, Xyris, due to our 82% ownership at December 31, 1998. Further expansions in general and administrative expenses took place in legal, finance and business development to support our expanded research and development efforts. These increases for 1998 were offset in part by the elimination of approximately $3.0 million of outside service costs, executive management, and other administrative expense from the combining of Arris (as the company was previously known) and Sequana. If the acquisition of Sequana had occurred prior to 1997, pro forma basis general and administrative expenses would have been $12.5 million in 1997. The increase, on a pro forma basis to $14.5 million in 1998 from $12.5 million in 1997 was primarily due to one-time charges related to the integration of Sequana, as well as the other administrative costs discussed above. Acquired In-Process Research and Development Acquired in-process research and development (IPR&D) expense increased to $124.9 million for the year ended December 31, 1998 due to our acquisition of Sequana Therapeutics on January 8, 1998. That acquisition was accounted for using the purchase method of accounting and the $174.1 million purchase price was allocated to the various tangible and intangible assets acquired based on their respective estimated fair values. As a result, $124.9 million was allocated to acquired IPR&D. The $124.9 million was expensed as a non-recurring charge on the acquisition date because the acquired in-process technology had not yet reached technological feasibility, had no future alternative uses, and all programs were still in the research phase. The value of Sequana's projects was determined after estimating the net cash flows from such projects, and discounting the net cash flows back to their present value. The net cash flows were based on the Company's estimate of revenue, research and development costs, general and administrative costs and income taxes. When we acquired Sequana in January 1998, Sequana had the following research programs in progress: Asthma, partnered with Boehringer Ingelheim Int'l GmbH; Osteoporosis, partnered with Corange International Ltd.; Non-Insulin Dependant Diabetes Mellitus (NIDDM), partnered with Glaxo Wellcome, Inc.; Schizophrenia/Bipolar, partnered with Parke-Davis Pharmaceutical Research division of Warner-Lambert Company; Obesity, Alzheimer's and Pharmacogenomics. As of December 31, 1999 the Schizophrenia/ Bipolar program was transferred to Parke-Davis and the Pharmacogenomics program was spun off into the PPGx subsidiary with PPD. All other programs have ended. 32 33 Interest Income and Interest Expense Interest income increased to $4.7 million for the year ended December 31, 1998, from $3.4 million in 1997. The increase was primarily due to the increase in average cash and investment balances between the periods, as a result of the acquisition of Sequana. Interest expense increased to $2.4 million for the year ended December 31, 1998, from $1.0 in 1997. The increase was primarily due to the higher debt balances from our two lines of credit and existing leasing arrangements following the acquisition of Sequana. We have generally used drawdowns from its lending arrangements for capital equipment leasehold improvements. Equity Interest in Loss of Joint Venture Equity interest in loss of joint venture increased to $2.4 million for the year ended December 31, 1998, and was due to the increase in the loss for Genos, which was acquired as part of our acquisition of Sequana. This amount represents our 50% portion of Genos' loss for 1998 based on our percentage ownership. Minority Interest Minority interest represents another investor's share of a subsidiary's operating income (loss), where we own 51% to 99% of that subsidiary. Minority interest increased to $112,000 for the year ended December 1998, from none in 1997. This amount is the result of the formation of our majority owned subsidiary, Xyris. Since we report all of Xyris' expenses as our expenses (see "General and Administrative" above), this one line allocates a portion of Xyris' loss to the minority shareholders, and reduces our operating loss. Recent accounting pronouncements In December 1999 the SEC issued Staff Accounting Bulletin No. 101, "Revenue Recognition in Financial Statements." SAB 101 requires that license and other up-front fees from research collaborators be recognized over the term of the agreement unless the fee is in exchange for products delivered or services performed that represent the culmination of a separate earnings process. The effect of this change in accounting principle will not have a material effect on our operating results or financial position. In June 1998, the Financial Accounting Standards Board issued Statement of Financial Accounting Standards No. 133, "Accounting for derivative Financial Instruments and for Hedging Activities" ("SFAS 133") which provides a comprehensive and consistent standard for the recognition and measurement of derivatives and hedging activities. SFAS 133 is effective for fiscal years beginning after June 15, 1999 and is not anticipated to have an impact on our results of operations of financial condition when adopted as we hold no derivative financial instruments and does not currently engage in hedging activities. LIQUIDITY AND CAPITAL RESOURCES We have financed our operations since inception primarily through private and public offerings of capital stock, through corporate collaborative research agreements, and sales of combinatorial chemistry compounds. As of December 31, 1999, we had realized approximately $183 million in net proceeds from offerings of our capital stock. In addition, we have realized approximately $199 million since inception from our collaborative research agreements and the sale of compound libraries. Our principal sources of liquidity are our cash and investments, which totaled $26.7 million as of December 31, 1999. We have a $30 million line of credit under which we had borrowed a total of $17 million as of December 31, 1999. The line is available through July, 2002. PPGx has an $8 million line of credit that is guaranteed by PPD, under which it had borrowed $6 million as of December 31, 1999. This line is available through June, 2000. Our cash and investments at December 31, 1999 include the cash and investments from our wholly-owned and majority-owned subsidiaries. Our investments also serve as security for our borrowings under our line of credit. Net cash used in operating activities during year ended December 31, 1999 was $39.3 million compared to $27.2 million in the same period in 1998. The increase was primarily due to lower revenues and the costs associated with the wind down of operations in La Jolla for the year ended December 31, 1999. Cash used in 33 34 operating activities is expected to fluctuate from quarter to quarter depending in part upon the timing and amounts, if any, of cash received from existing and any new collaboration agreements or the sale of combinatorial chemistry compound libraries. We also spent approximately $8.9 million for the purchase of property, plant and equipment during the year ended December 31, 1999. We expect to acquire or lease additional equipment in connection with our future research and development activities, although the magnitude of such purchases or leases is not presently known. There were no material commitments for capital expenditures outstanding at December 31, 1999. Our AAT subsidiary currently has approximately $27.7 million of backlog from committed contracts for the sale of combinatorial chemistry libraries as of December 31, 1999. Our material commitments at December 31, 1999 included our obligations to perform research under our collaboration agreements with Merck and Aventis (for which we are fully funded from our partner), our obligations to develop, produce and deliver combinatorial compounds and transfer related technology under AAT's combinatorial chemistry agreements with Parke-Davis, Daiichi and Allergan (for which we receive payments in excess of our costs), our obligations to pay for research at Signal Pharmaceuticals and our obligations under our line of credit. We believe that our existing cash and investments (including the proceeds of the $31.5 million stock issuance described below) will be more than sufficient for us to fulfill our commitments to Signal Pharmaceuticals for research support of approximately $1.5 million in 2000 and the lender under our line of credit, which had a $17 million balance outstanding at December 31, 1999. See also Note 10 to the company's financial statements for all of the company's commitments under Capital and Operating leases. In February, 2000, we entered into definitive purchase agreements for the sale of an aggregate 3.5 million newly issued shares of Axys Pharmaceuticals, Inc. common stock to selected institutional and other accredited investors for $31.5 million in gross proceeds. We intend to use net proceeds from this private placement for working capital and other general corporate purposes. We expect that existing cash and investments, revenues from existing collaborations, and the net proceeds from our recently completed private placement, together with debt financing which we believe is available to us, will enable us to maintain current and planned operations for 18-24 months. We continue to actively pursue a variety of financing alternatives. The drug development process is expensive and we are at an early stage of development. Therefore, we expect we will continue to need to raise money in the future until we achieve substantial product or royalty revenues, if ever. We expect that we will continue to seek additional funding from time to time through one or more of the following: new collaborations, the extension of existing collaborations, the sale of our interests in our affiliated businesses, or through public or private equity or debt financings. Furthermore, we may obtain funds through arrangements with collaborative partners or others that require us to give up rights to technologies or products that we would otherwise seek to develop or commercialize ourselves. We cannot be certain that additional funding will be available or that, if available, the terms will be acceptable. Existing stockholders will experience dilution of their investment if additional funds are raised through private or public stock sales. If adequate funds are not available, we may delay, reduce or eliminate any of our research or development programs. IMPACT OF THE YEAR 2000 In prior years, we discussed the nature and progress of our plans to become Year 2000 ready. In late 1999, we completed our remediation and testing of systems. As a result of those planning and implementation efforts, we experienced no significant disruptions in mission critical information technology and non-information technology systems and believe those systems successfully responded to the Year 2000 date change. We are not aware of any material problems resulting from Year 2000 issues, either with our products, our internal systems, or the products and services of third parties. We expensed approximately $119,000 during 1999 and $0 in 1998 in connection with remediating our systems. During 2000, we expect to remediate 34 35 certain non-critical systems at an estimated cost of $40,000 that will be funded through operating cash flows. Any remaining expense relates to other remediation efforts and will be charged to expense as incurred. We will continue to monitor our mission critical computer applications and those of our suppliers and vendors throughout the year 2000 to ensure that any latent Year 2000 matters that may arise are addressed promptly. ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK Due to the composition of our interest earning assets (88% mature within one year) and interest bearing liabilities, we believe that the market risk is not significant. ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA AXYS PHARMACEUTICALS, INC. INDEX TO FINANCIAL STATEMENTS YEARS ENDED DECEMBER 31, 1999, 1998 AND 1997 WITH REPORT OF INDEPENDENT AUDITORS
PAGE ---- Report of Ernst & Young LLP, Independent Auditors........... 36 Consolidated Balance Sheets................................. 37 Consolidated Statements of Operations....................... 38 Consolidated Statement of Stockholders' Equity.............. 39 Consolidated Statements of Cash Flows....................... 40 Notes to Consolidated Financial Statements.................. 41
35 36 REPORT OF ERNST & YOUNG LLP, INDEPENDENT AUDITORS Board of Directors and Stockholders Axys Pharmaceuticals, Inc. We have audited the accompanying consolidated balance sheets of Axys Pharmaceuticals, Inc. (formerly Arris Pharmaceutical Corporation) as of December 31, 1999 and 1998, and the related consolidated statements of operations, stockholders' equity and cash flows for each of the three years in the period ended December 31, 1999. These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on these financial statements based on our audits. We conducted our audits in accordance with auditing standards generally accepted in the United States. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion. In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the consolidated financial position of Axys Pharmaceuticals, Inc. at December 31, 1999 and 1998, and the consolidated results of its operations and its cash flows for each of the three years in the period ended December 31, 1999, in conformity with accounting principles generally accepted in the United States. ERNST & YOUNG LLP Palo Alto, California February 18, 2000 36 37 AXYS PHARMACEUTICALS, INC. CONSOLIDATED BALANCE SHEETS (IN THOUSANDS, EXCEPT SHARE AND PER SHARE AMOUNTS) ASSETS
DECEMBER 31, ---------------------- 1999 1998 --------- --------- Current assets: Cash and cash equivalents................................. $ 23,577 $ 36,261 Short-term marketable investments......................... 3,080 23,999 Accounts receivable, trade................................ 4,786 2,140 Inventories............................................... 2,258 435 Prepaid expenses and other current assets................. 1,524 4,513 --------- --------- Total current assets.............................. 35,225 67,348 Marketable investments...................................... -- 12,457 Property and equipment, net................................. 18,873 21,510 Investment in joint venture................................. -- 1,908 Note receivable from officer................................ 715 821 Intangible assets, net...................................... -- 2,200 Other assets................................................ 921 1,018 --------- --------- $ 55,734 $ 107,262 ========= ========= LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable.......................................... $ 4,563 $ 3,788 Accrued compensation...................................... 2,980 4,232 Other accrued liabilities................................. 5,284 2,956 Deferred revenue.......................................... 2,083 8,698 Current portion of capital lease and debt obligations..... 23,646 9,872 --------- --------- Total current liabilities......................... 38,556 29,546 Capital lease and debt obligations, noncurrent.............. 57 16,816 Minority interest........................................... 3,074 388 Commitments Stockholders' equity: Preferred stock, $0.001 par value, 10,000,000 shares authorized, none issued or outstanding................. -- -- Common stock, $0.001 par value, 50,000,000 shares authorized, 30,471,281 and 30,234,150 shares issued and outstanding at December 31, 1999 and 1998, respectively........................................... 291,328 290,291 Accumulated other comprehensive income (loss)............... (70) 116 Accumulated deficit......................................... (277,211) (229,895) --------- --------- Total stockholders' equity........................ 14,047 60,512 --------- --------- $ 55,734 $ 107,262 ========= =========
See accompanying notes. 37 38 AXYS PHARMACEUTICALS, INC. CONSOLIDATED STATEMENTS OF OPERATIONS (IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)
YEAR ENDED DECEMBER 31, --------------------------------- 1999 1998 1997(1) -------- --------- -------- Revenues: Collaboration and licensing revenues.................... $ 25,329 $ 38,910 $ 22,499 Product revenues........................................ 12,928 8,512 2,315 -------- --------- -------- Total revenues.................................. 38,257 47,422 24,814 Operating costs and expenses: Cost of goods sold...................................... 2,698 2,058 1,010 Research and development................................ 65,504 62,176 30,040 General and administrative.............................. 14,093 14,460 7,153 Restructuring charge.................................... 5,175 -- -- Acquired in-process research and development............ -- 124,888 -- -------- --------- -------- Total operating costs and expenses.............. 87,470 203,582 38,203 -------- --------- -------- Operating loss............................................ (49,213) (156,160) (13,389) Interest income........................................... 2,346 4,720 3,436 Interest expense.......................................... (2,086) (2,403) (1,014) Equity interest in loss of joint venture.................. (836) (2,393) -- Minority interest......................................... 1,879 112 -- Other income/(expense).................................... (853) -- -- -------- --------- -------- Net loss.................................................. $(48,763) $(156,124) $(10,967) ======== ========= ======== Basic and diluted net loss per share...................... $ (1.60) $ (5.25) $ (0.73) ======== ========= ======== Shares used in computing basic and diluted net loss per share................................................... 30,385 29,758 15,025 ======== ========= ========
- --------------- (1) Represents the results of Arris Pharmaceutical Corporation only. See accompanying notes. 38 39 AXYS PHARMACEUTICALS, INC. CONSOLIDATED STATEMENT OF STOCKHOLDERS' EQUITY (IN THOUSANDS, EXCEPT SHARE AND PER SHARE AMOUNTS)
ACCUMULATED NOTE OTHER COMMON STOCK RECEIVABLE COMPREHENSIVE TOTAL --------------------- FROM INCOME ACCUMULATED STOCKHOLDERS' SHARES AMOUNT OFFICER (LOSS) DEFICIT EQUITY ---------- -------- ---------- ------------- ----------- ------------- Balances at December 31, 1996.................. 14,831,975 $115,904 $(200) $ -- $ (62,804) $ 52,900 Exercise of options and a warrant to purchase common stock................................. 313,000 1,327 -- -- -- 1,327 Issuance of common stock in connection with the ESPP......................................... 58,114 555 -- -- -- 555 Forgiveness of note receivable................. -- -- 75 -- -- 75 Net loss and comprehensive loss................ -- -- -- -- (10,967) (10,967) ---------- -------- ----- ----- --------- --------- Balances at December 31, 1997.................. 15,203,089 117,786 (125) -- (73,771) 43,890 Exercise of options and warrants to purchase common stock................................. 91,649 621 -- -- -- 621 Issuance of common stock for cash.............. 132,254 1,063 -- -- -- 1,063 Issuance of common stock in connection with the ESPP......................................... 189,145 1,091 -- -- -- 1,091 Issuance of common stock in connection with the acquisition of Sequana Therapeutics, Inc..... 14,618,013 169,730 -- -- -- 169,730 Forgiveness of note receivable................. -- -- 125 -- -- 125 Net loss....................................... -- -- -- -- (156,124) (156,124) Unrealized gain on securities.................. -- -- -- 116 -- 116 --------- Comprehensive loss............................. (156,008) ---------- -------- ----- ----- --------- --------- Balance at December 31, 1998................... 30,234,150 290,291 -- 116 (229,895) 60,512 Exercise of options and warrants to purchase common stock................................. 34,874 132 -- -- -- 132 Issuance of common stock in connection with the ESPP......................................... 202,257 905 -- -- -- 905 Deconsolidation of Akkadix Corporation......... -- -- -- -- 1,447 1,447 Net loss....................................... -- -- -- -- (48,763) (48,763) Unrealized loss on securities.................. -- -- -- (186) -- (186) --------- Comprehensive loss............................. (48,949) ---------- -------- ----- ----- --------- --------- Balance at December 31, 1999................... 30,471,281 $291,328 $ -- $ (70) $(277,211) $ 14,047 ========== ======== ===== ===== ========= =========
See accompanying notes. 39 40 AXYS PHARMACEUTICALS, INC. CONSOLIDATED STATEMENTS OF CASH FLOWS INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
YEAR ENDED DECEMBER 31, --------------------------------- 1999 1998 1997(1) -------- --------- -------- (IN THOUSANDS) Cash flows from operating activities Net loss.................................................. $(48,763) $(156,124) $(10,967) Adjustments to reconcile net loss to net cash used in operating activities: Non-cash restructure charge............................. 1,598 -- Depreciation and amortization........................... 11,135 10,156 4,183 (Gain)loss on disposal of fixed assets.................. (176) 44 -- Equity interest in loss of joint venture................ 836 2,393 -- Acquired in-process research and development............ -- 124,888 -- Forgiveness of note receivable from officer............. 160 155 75 Minority interest....................................... 1,879 388 -- Changes in assets and liabilities: Accounts receivable................................... (2,646) (839) (1,301) Inventories........................................... (1,823) (435) -- Prepaid expenses and other current assets............. 3,254 636 (585) Other assets.......................................... 43 (2,469) (345) Accounts payable...................................... 775 (5,818) 183 Accrued compensation.................................. (1,252) 2,440 313 Other accrued liabilities............................. 2,328 808 578 Deferred revenue...................................... (6,615) (3,382) (6,620) -------- --------- -------- Net cash and cash equivalents used in operating activities................................................ (39,267) (27,159) (14,486) Cash flows from investing activities Available for-sale-securities: Purchases............................................... (77,003) (56,065) (22,092) Maturities.............................................. 110,193 92,105 3,249 Held-to-maturity securities: Purchases............................................... -- -- (9,683) Maturities.............................................. -- -- 46,704 Sale of restricted cash and investments..................... -- -- 7,250 Acquisition, net of cash received........................... -- 13,270 -- Investment in joint venture................................. (25) (2,000) -- Change in investment in consolidated subsidiaries and affiliates................................................ 3,351 -- -- Proceeds from sale of property and equipment................ 877 119 -- Expenditures for property and equipment..................... (8,862) (8,263) (6,297) -------- --------- -------- Net cash and cash equivalents provided by investing activities................................................ 28,531 39,166 19,131 Cash flows from financing activities Net proceeds from issuance of common stock................ 1,037 2,775 1,882 Proceeds from issuance of note payable and capital lease obligations............................................. 53,292 6,174 19,115 Principal payments on note payable and capital lease obligations............................................. (56,277) (7,633) (13,526) -------- --------- -------- Net cash and cash equivalents (used by) provided by financing activities...................................... (1,948) 1,316 7,471 -------- --------- -------- Net (decrease) increase in cash and cash equivalents........ (12,684) 13,323 12,116 Cash and cash equivalents, beginning of year................ 36,261 22,938 10,822 -------- --------- -------- Cash and cash equivalents, end of year...................... $ 23,577 $ 36,261 $ 22,938 ======== ========= ======== Supplemental disclosure of cash flows information: Cash paid during the year for interest.................... $ 2,130 $ 2,284 $ 826 ======== ========= ======== Supplemental schedule of noncash investing and financing activities: Issuance of common stock and value of options and warrants issued in acquisitions.................................. $ -- $ 169,730 $ -- ======== ========= ======== Noncash acquisition of equipment under capital lease...... $ -- $ -- $ 1,719 ======== ========= ========
- --------------- (1) Represents the results of Arris Pharmaceutical Corporation only. See accompanying notes. 40 41 AXYS PHARMACEUTICALS, INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS 1. ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Organization Axys Pharmaceuticals, Inc., a Delaware corporation ("Axys" or the "Company"), formerly known as Arris Pharmaceutical Corporation ("Arris"), is an early-stage biopharmaceutical company focused on the discovery, development and commercialization of small molecules. The Company focuses its own resources on discovering and developing therapeutics for the treatment of various types of cancer and collaborates with large pharmaceutical companies in discovering therapeutics for chronic diseases for which there are large markets. The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries, Axys Advanced Technologies, Inc., Arris Pharmaceuticals Canada, Inc., and Sequana Therapeutics, Inc. ("Sequana") (See "Acquisition of Sequana", Note 3), and includes the accounts of PPGx, Inc., a majority owned subsidiary of the Company (See "Formation of PPGx, Inc.", Note 6). All significant intercompany accounts and transactions have been eliminated. The Company owns approximately 38% of Akkadix Corporation ("Akkadix"), formerly known as Xyris Corporation (See "Formation of Akkadix Corporation", Note 5). The Company owns 50% of Genos, a joint venture with Memorial Sloan-Kettering Cancer Center ("MSKCC"). These investments are accounted for under the equity method. 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 amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates, and such differences could be material. Cash and Cash Equivalents and Investments The Company considers all highly liquid investments with maturities of three months or less at the date of purchase to be cash equivalents. Investments with maturities greater than three months and less than one year are classified as short-term investments. Management determines the appropriate classification of debt securities at the time of purchase and reevaluates such designation as of each balance sheet date. The Company currently considers all its investment securities as available-for-sale. Available-for-sale securities are reported at estimated fair market value with the related unrealized gains and losses included in stockholders' equity. Realized gains and losses, and declines in value judged to be other than temporary are included in interest income and expense. Realized gains and losses have been immaterial. The cost of securities sold is based on the specific identification method. Inventories Inventories are stated at the lower of cost (first-in, first-out) or market. At December 31, 1999, inventories consisted of the following (in thousands): Raw materials............................... $ 156 Finished goods.............................. 2,102 ------ Total....................................... $2,258 ======
41 42 AXYS PHARMACEUTICALS, INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) Depreciation and Amortization Depreciation is provided using the straight-line method over the estimated useful lives of the respective assets. Machinery and equipment has estimated useful lives ranging from 3 to 5 years and furniture and office equipment has a useful life of 5 years. Purchased computer software is amortized over 3 years. Leasehold improvements are amortized over the term of the lease or economic useful life, whichever is shorter. Revenue Recognition The Company recognizes revenues from its collaborative research programs, as well as from product sales. The company's collaborative research programs generally contain one or more of the following sources of revenue: - Research Support: Payments that are generally based on the number of researchers Axys is committing to a particular program. These revenues are recorded when earned through the performance of the required research by Axys. - License Fees: Payments that are generally received when the collaboration agreement is signed. These revenues are amortized over the term of the agreement. - Commitment Fees: Payments that are generally received in conjunction with our commitment to perform certain funded research. These revenues are recorded over the course of the research efforts. - Milestone Payments: Payments that are based on our or our partner achieving certain technical or regulatory milestones in the collaboration. These revenues are recorded upon the achievement of mutually agreed upon milestones. - Premiums paid on Equity Investments: Premiums paid in excess of the fair market value of the Company's stock is recognized as revenue over the research period. Our sales of chemical compound libraries contain one or more of the following sources of revenue: - Product Sales: As chemical compound libraries are shipped to customers of AAT, we record revenue based on the contracted price per compound. - License Fees: Payments that are generally received when compound supply or technology license agreements are signed. These revenues are recognized over the term of the agreement. - Commitment Fees: Payments that are received in conjunction with AAT's commitment to perform certain obligations under compound supply or technology license agreements. These revenues are recorded over the course of the relevant agreement, as performance obligations are completed. - Protocol Fees: Payments that are received in exchange for technology know-how. These revenues are recorded as protocols are delivered. Research and Development Research and development expenses consist of costs incurred for independent and collaborative research and development. These costs include direct costs and research-related overhead expenses. Research and development expenses under the collaborative research agreements approximate the research support revenue recognized under the agreements of $16,649,000, $24,804,000, and $13,622,000, in 1999, 1998 and 1997 respectively. 42 43 AXYS PHARMACEUTICALS, INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) Stock-Based Compensation As permitted by Statement of Financial Accounting Standards No. 123, "Accounting for Stock-Based Compensation" ("FAS 123"), the Company has elected to continue to follow Accounting Principles Board Opinion No. 25 "Accounting for Stock Issued to Employees" ("APB 25") and related interpretations in accounting for its employee stock option and purchase plans. See Note 9 for pro forma disclosures required by FAS 123. Net Loss Per Share Basic earnings per share is computed based on the weighted average number of shares of the Company's common stock outstanding. In addition, there were other dilutive securities in the form of options and warrants to purchase 4,876,824, 5,050,026 and 2,168,860 shares of common stock outstanding at December 31, 1999, 1998, and 1997, respectively. These shares, which would normally be included in the computation of dilutive earnings per share, were not included in that computation because the effect would be antidilutive. Comprehensive Income As of January 1, 1998, the Company adopted the Statement of Financial Accounting Standards No. 130 (FAS 130), "Reporting Comprehensive Income." Comprehensive loss is comprised of reported net loss and unrealized holding gains and losses on available-for-sale securities. Comprehensive loss has been shown in the Consolidated Statements of Stockholders' Equity. Segment Information As of January 1, 1998, the Company adopted Statement of Financial Accounting Standards No. 131, "Disclosures about Segments of an Enterprise and Related Information" (FAS 131). FAS 131 superseded FASB Statement No. 14, "Financial Reporting for Segments of a Business Enterprise." FAS 131 establishes standards for the way that public business enterprises report information about operating segments in annual financial statements and requires that those enterprises report selected information about operating segments in interim financial reports. FAS 131 also establishes standards for related disclosures about products and services, geographical areas, and major customers. The adoption of FAS 131 did not affect results of operations or financial position, but did affect the disclosure of segment information (see "Segment Information", Note 13). Recent accounting pronouncements In June 1998, the Financial Accounting Standards Board issued Statement of Financial Accounting Standards No. 133, "Accounting for derivative Financial Instruments and for Hedging Activities" ("SFAS 133") which provides a comprehensive and consistent standard for the recognition and measurement of derivatives and hedging activities. SFAS 133 is effective for fiscal years beginning after June 15, 1999 and is not anticipated to have an impact on the Company's results of operations of financial condition when adopted as the Company holds no derivative financial instruments and does not currently engage in hedging activities. In December 1999 the SEC issued Staff Accounting Bulletin No. 101, "Revenue Recognition in Financial Statements." SAB 101 requires that license and other up-front fees from research collaborators be recognized over the term of the agreement unless the fee is in exchange for products delivered or services performed that represent the culmination of a separate earnings process. The effect of this change in accounting principle will not have a material effect on the Company's prior period results. Reclassifications Certain prior year amounts have been reclassified to conform to the 1999 presentation. 43 44 AXYS PHARMACEUTICALS, INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) 2. RESTRUCTURING CHARGE In December 1999, the Company completed the closing of its San Diego, CA operations and relocated its oncology genomics activities to its South San Francisco headquarters. As a result of this action, a one-time charge of $7.0 million was taken during the third quarter, of which $2.2 million related to severance and other employee-related costs, $1.7 million related to facilities costs, $1.8 million related to the disposal of assets, and $1.3 in other costs associated with the restructuring. In the fourth quarter of 1999 the restructure charge was reduced by $1.8 million to $5.2 million due to a change in estimates resulting from the additional subleases of the San Diego facility leased by the Company, and for better than expected proceeds from the disposal of equipment and other assets associated with closing down the San Diego facility. The facilities costs included lease payments on facilities vacated in San Diego net of proceeds from existing subleases. As a result of closing the facility, the Company eliminated 120 positions of which 93 are included in the severance calculation and 27 positions were eliminated through attrition and cancellation of open requisitions. The following table summarizes the Company's 1999 restructuring charge activity for the twelve months ended December 31, 1999 (in thousands):
Q3, 1999 Q4, 1999 Q4 RESERVE CASH/ RESTRUCTURE CHANGE IN PAYMENT/ BALANCE DESCRIPTION NON/CASH CHARGE ESTIMATE WRITE-OFF AT 12/31/99 ----------- -------- ----------- --------- --------- ----------- Severance and benefits..................... Cash $(2,210) $ -- $1,115 $(1,095) Facilities................................. Cash (1,664) 511 405 (748) Contractual Research Commitments........... Cash (214) -- 133 (81) ------- ------ ------ ------- Subtotal -- Cash........................... (4,088) 511 1,653 (1,924) ------- ------ ------ ------- Work-force in Place and Other.............. Non-Cash (1,110) -- 1,110 -- Equipment disposal......................... Non-Cash (1,810) 1,322 488 -- ------- ------ ------ ------- Subtotal -- Non-Cash....................... (2,920) 1,322 1,598 -- ------- ------ ------ ------- Total............................ $(7,008) $1,833 $3,251 $(1,924) ======= ====== ====== =======
The Company anticipates that the remaining accruals for severance and benefits will be utilized by December 31, 2000 and the remaining accruals for committed payments will be utilized by March 31, 2000. The Company anticipates that the remaining accruals for facilities will be utilized over the period through lease termination on December 31, 2001. 3. ACQUISITION OF SEQUANA On January 8, 1998, the Company acquired all of the outstanding capital stock of Sequana, a genomics company that used industrial-scale gene discovery technology and functional genomics to discover and characterize genes that cause certain common diseases. The Company issued shares of Axys Common Stock in exchange for all the outstanding common stock of Sequana, on the basis of 1.35 shares of Axys' common stock for one share of Sequana common stock. The purchase price of $174,070,000 consisted of (i) the issuance of 14,618,013 shares of Company common stock valued at $168,107,000, in exchange for all outstanding Sequana capital stock, (ii) the issuance of Company warrants valued at $1,623,000 in exchange for all of the outstanding Sequana warrants, and (iii) transaction costs totaling $4,340,000. The allocation of the purchase price was determined as follows: Net tangible assets acquired................................ $ 45,882,000 Assembled workforce of Sequana.............................. 3,300,000 Acquired in-process research and development................ 124,888,000 ------------ Total............................................. $174,070,000 ============
44 45 AXYS PHARMACEUTICALS, INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) The acquisition has been accounted for as a purchase and accordingly, the original purchase price was allocated to acquired assets and assumed liabilities based upon their estimated fair values at the date of acquisition, and to the estimated fair value of in-process research and development ("IPR&D") was charged as an expense in the Axys consolidated financial statements as such acquired IPR&D had not reached technological feasibility. Intangible assets were being amortized on a straight-line basis over 36 months. The September 30, 1999 unamortized balance of $1.3 million for the assembled work force was written off in connection with the Company's third-quarter restructuring. The value allocated to purchased IPR&D was determined by estimating the costs to develop the purchased in-process technology into viable products, estimating the resulting net cash flows from such projects, and discounting the net cash flows back to their present value. The discount rate included a factor that takes into account the Company's weighted average cost of capital and the uncertainty surrounding the successful development of the purchased in-process technology. The acquired in-process research and development projects in the Sequana acquisition consisted of eight significant research and development projects. As of December 31, 1999, the schizophrenia/bipolar program was transferred to Parke-Davis and the pharmacogenomics program was spun off into the PPGx subsidiary. All other programs have been terminated. The operating results of Sequana from January 1, 1998 to December 31, 1998 have been included in the Company's consolidated results of operations. The operating results of Sequana from January 1, 1998 to January 8, 1998 (date of acquisition) are considered immaterial. The following unaudited pro forma financial summary is presented as if the operations of the Company and Sequana were combined as of January 1, 1997. The unaudited pro forma combined results are not necessarily indicative of the actual results that would have occurred had the acquisition been consummated at that date, or of the future operations of the combined entities. Nonrecurring charges, such as the acquired in-process research and development charge of $124.9 million are not reflected in the following pro forma financial summary. PRO FORMA FINANCIAL SUMMARY FOR THE YEAR ENDED DECEMBER 31, 1997 (UNAUDITED)
(IN THOUSANDS, EXCEPT PER SHARE AMOUNT) ------------------------- Contract Revenues....................................... $ 44,399 Net Loss................................................ $(26,108) Basic and diluted net loss per share.................... $ (0.89)
4. INVESTMENT IN JOINT VENTURE In January 1997, Sequana formed Genos with Memorial Sloan-Kettering Cancer Center to focus on research and identification of genes and related genetic information of values in the prognosis, diagnosis and positive treatment of certain common cancers. As of December 31, 1998 Sequana had invested $5.2 million and licensed certain of its technology to Genos and has contracted with Genos to conduct research and provide certain other services to the joint venture. Payments to date for such research and services have not been material. In May 1999, the Board of Directors of Genos decided to suspend its research activities and wind up its affairs. The Company is receiving back rights to use its technology in the identification of programs in oncology from Genos. As a result of winding up of Genos, the Company has taken a one-time charge of $1.1 million in the third quarter of 1999, representing the total carrying value of the investment in Genos, which is included in other expense in the consolidated statement of operations. 45 46 AXYS PHARMACEUTICALS, INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) In connection with the formation of Genos, Sequana issued a warrant to MSKCC to purchase 350,000 shares of Sequana's common stock. That warrant was assumed by the Company as part of the acquisition of Sequana on January 8, 1998, and was converted to a warrant to purchase an aggregate of 472,500 shares of Axys common stock at a price of $12.87 per share and expires in September 2000. 5. FORMATION OF AKKADIX CORPORATION In May 1998, the Company formed a majority owned subsidiary, Akkadix Corporation ("Akkadix", formerly known as Xyris Corporation), which was established to leverage Axys' existing pharmaceutical technology in the agricultural biotechnology market. In connection with the formation of Akkadix, the Company granted Akkadix the right, for a limited period, to negotiate an exclusive license in the field of agriculture to all Axys technology in exchange for an 82% ownership interest. A third party contributed $500,000 cash in exchange for a 15% ownership interest in Akkadix. Under the terms of the financing, the Company granted the third party the right (the "Put Option") to require the Company to purchase all of the third party's interest in Xyris in exchange for that number of shares of the Company whose market value equals $500,000 at the date of the exercise of the Put Option. In February 1999, Akkadix executed an exclusive license to the Company's technology in the field of agriculture (the "Technology License"). The Company received additional shares of Akkadix in exchange for the Technology License. Also in February 1999, Akkadix closed a financing in which it raised $4.5 million from a third party. During the second quarter of 1999, Akkadix completed subsequent financing in which it raised $5 million from other third parties. Under the terms of these financings, and a prior $500,000 financing, the Company has granted the third parties the right (the "Put Option") to require the Company to purchase all of the their interests in Akkadix in exchange for that number of shares of the Company whose market value equals $10 million at the date of the exercise of the Put Option. The Put Option may be exercised at any time through February 2, 2001. On September 9, 1999 Akkadix completed its acquisition of Global Agro, Inc. ("Global"), a privately held California corporation. Under the terms of the merger, all outstanding shares of Global stock were converted into Series B preferred stock of Akkadix. On November 1, 1999 Akkadix exchanged 100,000 shares of Series C preferred stock for all of the net assets of Maize Genetic Resources, Inc. ("Maize"), a privately held foundation seed corn company. Both acquisitions were accounted for as a purchase. The net effect of issuance of shares in connection with the financings and acquisitions by Akkadix of other companies has changed the Company's ownership in Akkadix from 82% at December 31, 1998, to 52% at June 30, 1999, to 39.3% at September 30, 1999 and finally to 38.3% at December 31, 1999. Therefore, Akkadix' balance sheet is no longer consolidated into the Company's balance sheet from and after September 9, 1999 when the Company's ownership fell below 50%. Akkadix's results of operations are included with the Company's results of operations through the date of merger between Akkadix and Global. Subsequent to the acquisition of Global, the Company deconsolidated the effects of Akkadix from the Balance Sheet through the Statement of Stockholders Equity and accounted for its investment in Akkadix using the equity method of accounting. 6. FORMATION OF PPGX, INC. In February 1999, the Company announced the formation of a majority-owned subsidiary, PPGx, Inc. ("PPGx"), which is engaged in the business of providing pharmacogenomic (the science of how genetic variations among individuals affects drug safety and efficacy) products and services to the pharmaceutical and biotechnology industries. In connection with the formation of PPGx, Axys contributed certain fixed assets, which were recorded at the Company's net book value, and technology in exchange for an 82% ownership 46 47 AXYS PHARMACEUTICALS, INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) interest in PPGx. PPD, Inc. ("PPD"), Axys' partner in PPGx, contributed certain assets, technology, cash and loan guarantees in exchange for an 18% ownership interest in PPGx and the exclusive, worldwide right to market the pharmacogenomic products and services of PPGx. Under the terms of a shareholder agreement between the Company and PPD, PPD has the option (the "PPD Option") to purchase 32% of PPGx from the Company at various escalating prices until February 1, 2002. Under certain circumstances, the Company has the option to put (the "Axys Put") 32% of PPGx to PPD. Upon exercise of the PPD Option or the Axys Put, the Company and PPD would have equal ownership positions in PPGx. At such time as either the PPD Option or the Axys Put is exercised, the Company would also become a co-guarantor of a certain PPGx line of credit to the extent any borrowings are outstanding at that time. Additionally, at any time after the fifth anniversary of the formation of PPGx, the Company and, provided either the PPD Option or the Axys Put have been exercised, PPD have the right to buy all of the outstanding equity interests in PPGx at fair market value in accordance with the terms of buy-sell provisions of the shareholder agreement. 7. FAIR VALUE OF FINANCIAL INSTRUMENTS Cash equivalents and marketable investments: The following is a summary of available-for-sale securities at December 31, 1999 and 1998:
GROSS GROSS ESTIMATED UNREALIZED UNREALIZED FAIR COST GAINS LOSSES VALUE ------- ---------- ---------- --------- AT DECEMBER 31, 1999: Commercial paper of U.S. corporations.......... $ 3,317 $ -- $-- $ 3,317 U.S. treasury securities....................... 5,000 -- -- 5,000 Certificates of deposit........................ 28 -- -- 28 Securities of foreign corporations............. 2,148 -- 56 2,092 U.S. agency securities......................... 10,952 -- 14 10,938 ------- ---- --- ------- $21,445 $ -- $70 $21,375 ======= ==== === ======= AT DECEMBER 31, 1998: Commercial paper of U.S. corporations.......... $23,572 $ 35 $-- $23,607 U.S. treasury securities....................... 500 1 -- 501 Certificates of deposit........................ 4,003 9 -- 4,012 Securities of foreign corporations............. 3,431 13 -- 3,444 U.S. agency securities......................... 7,801 24 -- 7,825 Municipal obligations.......................... 4,001 34 -- 4,035 ------- ---- --- ------- $43,308 $116 $-- $43,424 ======= ==== === ======= Balance sheet classification: AT DECEMBER 31, 1999: Cash equivalents............................... $18,295 $ -- $-- $18,295 Short-term marketable investments.............. 3,150 -- 70 3,080 ------- ---- --- ------- $21,445 $ -- $70 $21,375 ======= ==== === ======= AT DECEMBER 31, 1998: Cash equivalents............................... $ 6,967 $ 1 $-- $ 6,968 Short-term marketable investments.............. 23,928 71 -- 23,999 Marketable investments......................... 12,413 44 -- 12,457 ------- ---- --- ------- $43,308 $116 $-- $43,424 ======= ==== === =======
47 48 AXYS PHARMACEUTICALS, INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) Estimated fair value of other financial instruments: The carrying value of the notes payable approximate their estimated fair value. The fair value of the notes payable was estimated based on current interest rates available to the Company for debt instruments with similar terms, degree of risk and remaining maturities. The carrying values of all other financial instruments approximate their estimated fair values, any realized gains and losses recognized have been immaterial. 8. PROPERTY AND EQUIPMENT Property and equipment is recorded at cost and consists of the following:
DECEMBER 31, ------------------ 1999 1998 ------- ------- (IN THOUSANDS) Machinery and equipment.................................. $29,119 $33,039 Purchased software....................................... 1,946 1,748 Furniture and office equipment........................... 2,702 2,220 Leasehold improvements................................... 14,614 12,420 Construction in progress................................. 227 262 ------- ------- 48,608 49,689 Less accumulated depreciation and amortization........... 29,735 28,179 ------- ------- $78,343 $77,868 ======= =======
Property and equipment includes approximately $14,168,000 and $15,011,000 recorded under capital leases at December 31, 1999 and 1998, respectively. Amortization is included with depreciation expense. Accumulated amortization of equipment under capital leases was approximately $13,891,000 and $12,886,000 at December 31, 1999 and 1998, respectively. 9. STOCKHOLDERS' EQUITY Common Stock At December 31, 1999 common stock was reserved for issuance as follows (in thousands): Stock options (including the Stock Bonus Plan).............. 5,234 Warrants.................................................... 678 Employee stock purchase plan................................ 559 ----- 6,471 =====
Stock Options The Company has various equity incentive plans under which it issues stock options to employees, consultants and members of the Board of Directors. The Company's plans include the 1997 Equity Incentive Plan under which incentive stock options or non-qualified stock options may be granted, or restricted stock may be issued, at the discretion of the Board of Directors to employees, directors and consultants to purchase the Company's common stock; the 1997 Non-Officer Equity Incentive Plan, under which non-officer employees and consultants may be granted non-qualified stock options to purchase the Company's common stock; the 1989 Stock Option Plan, under which directors, officers, employees, and consultants may be issued restricted stock, or granted incentive stock options or nonqualified stock options to purchase the Company's common stock, at the discretion of the Board of Directors; and the 1994 Non-Employee Directors' Stock Option Plan, whereby nonqualified stock options are automatically granted to non-employee directors to 48 49 AXYS PHARMACEUTICALS, INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) purchase the Company's Common stock. The 1989 Stock Option Plan expired in 1999, reducing by approximately 700,000 shares the number of shares available to be granted under all of the Company's plans. All options granted under these Plans become exercisable pursuant to the applicable terms of the grant. For stock options granted through December 31, 1997, the exercise price of the options was computed at the average market value of the Company's common stock for the 15 days preceding the grant date. For options granted after December 31, 1997, the exercise price is equal to the market value of the Company's common stock on the date of grant. Generally options vest ratably over four years and expire ten years from the date of grant. In October 1998, the Company offered its employees the right to exchange their then outstanding options to purchase shares of common stock with exercise prices ranging from $4.31 to $15.59, for new options to purchase shares with exercise prices of $4.00 per share for non-officer employees and $5.00 per share for executive officer employees. Under this program, options to purchase 3,643,387 shares were exchanged resulting in a decrease in aggregate purchase price from $34,254,046 to $15,560,548. All new options had an additional year of vesting added to the original vesting term. Transactions under all of the above equity incentive plans are as follows:
OUTSTANDING STOCK OPTIONS ------------------------------ WEIGHTED SHARES NUMBER OF AVERAGE AVAILABLE SHARES EXERCISE PRICE ---------- ---------- ---------------- Balances at December 31, 1996...................... 147,196 1,764,356 $ 9.10 ---------- ---------- ------ Shares reserved.................................. 1,750,000 -- -- Options granted.................................. (646,744) 646,744 $12.93 Options exercised................................ -- (281,694) $ 2.91 Options canceled................................. 129,782 (129,782) $11.26 ---------- ---------- Balances at December 31, 1997...................... 1,380,234 1,999,624 $11.06 ---------- ---------- ------ Shares reserved.................................. 2,850,000 -- Options granted.................................. (7,080,180) 7,080,180 $ 5.86 Options exercised................................ -- (226,193) $ 3.23 Options canceled................................. 4,433,158 (4,433,158) $ 9.28 ---------- ---------- Balances at December 31, 1998...................... 1,583,212 4,420,453 $ 4.80 ---------- ---------- ------ Shares reserved.................................. -- -- Options granted.................................. (1,699,539) 1,699,539 $ 4.31 Options exercised................................ -- (34,643) $ 3.38 Options canceled................................. 1,886,403 (1,886,403) $ 4.57 Shares expired................................... (735,135) -- -- ---------- ---------- ------ Balances at December 31, 1999...................... 1,034,941 4,198,946 $ 4.72 ========== ========== ======
The weighted average fair value of stock options outstanding under the plans were $4.72, $4.80 and $11.06 in 1999, 1998, and 1997, respectively. 49 50 AXYS PHARMACEUTICALS, INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) Options outstanding and exercisable by price range at December 31, 1999:
OPTIONS OUTSTANDING ---------------------------------------- OPTIONS EXERCISABLE WEIGHTED -------------------------- OPTIONS AVERAGE OPTIONS OUTSTANDING AT REMAINING WEIGHTED EXERCISABLE AT WEIGHTED DECEMBER 31, CONTRACTUAL AVERAGE DECEMBER 31, AVERAGE RANGE OF 1999 LIFE EXERCISE 1999 EXERCISE EXERCISE PRICES (SHARES) (IN YEARS) PRICE (SHARES) PRICE - ---------------- -------------- ----------- --------- -------------- --------- $0.35 - $ 3.94 714,387 9.02 $ 3.45 146,415 $ 2.65 $3.96 - $ 4.00 1,544,577 3.89 $ 4.00 777,587 $ 3.99 $4.06 - $ 5.00 1,314,456 6.36 $ 4.78 678,999 $ 4.89 $5.09 - $ 8.13 420,396 8.06 $ 6.09 191,315 $ 6.07 $8.38 - $15.36 205,130 7.40 $11.43 111,368 $11.88 --------- --------- 4,198,946 6.12 $ 4.72 1,905,684 $ 4.88 ========= =========
Warrants As of December 31, 1999, the Company had issued and outstanding warrants to purchase a total of 677,878 shares of the Company's common stock at prices ranging from $4.06 to $13.46 per share. These warrants expire at various dates from 2000 through 2005. Employee Stock Purchase Plan In October 1993, the Company adopted the 1993 Employee Stock Purchase Plan (the "Purchase Plan") under which employees who meet certain minimum employment criteria are eligible to participate. Eligible employees may purchase common stock of the Company at a purchase price of 85% of the lower of the fair market value of the stock at the offering commencement date or purchase date, within a two-year offering period. In 1999, the Board of Directors and, the Company's stockholders approved an additional 500,000 shares to be reserved under the Purchase Plan. Under the Purchase Plan, 202,257 shares were issued in 1999. Shareholders Rights Plan On October 8, 1998, the Board of Directors adopted a Preferred Share Purchase Rights Plan (the "Plan") designed to enable all stockholders to realize the full value of their investment and to provide for fair and equal treatment for all stockholders in the event an unsolicited attempt were made to acquire the Company. In connection with the Plan, the Board declared a dividend of one preferred share purchase right (a "Right") for each share of common stock of the Company outstanding on October 28, 1998 and further directed the issuance of one such right with respect to each share of the Company's common stock that is issued after October 28, 1998. If a person, entity or group of affiliated or associated persons acquires beneficial ownership of 15% or more of the Company's common stock, or announces a tender offer for 15% or more of the Company's common stock, the rights will be distributed. Each Right entitles the registered holder to purchase from the Company one one-hundredth of a share of Series A Junior Participating Preferred Stock, at a price of $35.00 per one one-hundredth of a Preferred Share subject to adjustment. The Rights are redeemable prior to any person's acquisition of more than 15% of the Company's common stock and will expire on October 7, 2008. Stock-Based Compensation The Company has elected to follow APB 25 and related interpretations in accounting for its stock-based compensation plans because, as discussed below, the alternative fair value accounting provided for under SFAS 123 requires use of option valuation models that were not developed for use in valuing employee stock 50 51 AXYS PHARMACEUTICALS, INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) options and employee stock-based awards. Compensation expense under APB 25 with respect to such awards has been immaterial. Pro Forma Disclosures Pro forma information regarding net loss and net loss per share is required by FAS 123, and has been determined as if the Company had accounted for its stock-based awards granted subsequent to December 31, 1994 under the fair value method of FAS 123. The fair value for these stock-based awards was estimated at the date of grant using a Black-Scholes option-pricing model. The Black-Scholes option valuation model was developed for use in estimating the fair value of traded options, which have no vesting restrictions and are fully transferable. In addition, option valuation models require the input of highly subjective assumptions including the expected stock price volatility. Because the Company's stock-based awards have characteristics significantly different from those of traded options, and because changes in the subjective input assumptions can materially affect the fair value estimate, in management's opinion, the existing models do not necessarily provide a reliable single measure of the fair value of the Company's stock-based awards to its employees. The fair value of the Company's stock-based awards to employees was estimated assuming no expected dividends and the following weighted-average assumptions:
EMPLOYEE STOCK OPTIONS PURCHASE PLAN -------------------- -------------------- 1999 1998 1997 1999 1998 1997 ---- ---- ---- ---- ---- ---- Expected life (years)............................ 3.0 3.0 3.0 0.5 0.5 0.5 Expected volatility.............................. 0.65 0.59 0.58 0.92 0.65 0.54 Risk-Free interest rate.......................... 5.58% 5.13% 6.23% 4.81% 5.17% 5.67%
For purposes of pro forma disclosures, the estimated fair value of the stock-based awards are amortized to pro forma net loss over the option's vesting period and the purchase plan's six-month purchase period. The Company's as reported and pro forma information follows (in thousands, except for net loss per share information):
YEAR ENDED DECEMBER --------------------------------- 1999 1998 1997 -------- --------- -------- Net loss As reported............................................. $(48,763) $(156,124) $(10,967) Pro forma............................................... $(52,757) $(163,470) $(14,418) Net loss per share -- basic and diluted As reported............................................. $ (1.60) $ (5.25) $ (0.73) Pro forma............................................... $ (1.74) $ (5.49) $ (0.96)
For pro forma purposes in accordance with FAS 123, the repricing of employee stock options during 1998 is treated as a modification of the stock-based award, with the original options being repurchased and new options granted. Any additional compensation arising from the modification is recognized over the remaining vesting period of the new grant. 10. COMMITMENTS Leases The Company leases office and laboratory facilities and equipment. Rent expense, net of sublease income of $1,385,000 in 1999 ($780,000 in 1998 and $597,000 in 1997), for the years ended December 31, 1999, 1998, and 1997 was approximately $2,168,000 $3,293,000, and $1,622,000, respectively. 51 52 AXYS PHARMACEUTICALS, INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) Future minimum lease payments under non-cancelable leases, net of non-cancelable sublease income of $1,882,000, $1,497,000 $816,000, $911,000, $930,000, and $549,000 for 2000, 2001, 2002, 2003, 2004 and thereafter, respectively, are as follows:
CAPITAL OPERATING LEASES LEASES ------- --------- (IN THOUSANDS) 2000...................................................... $ 548 $1,685 2001...................................................... -- 1,915 2002...................................................... -- 881 2003...................................................... -- 733 2004...................................................... -- 93 Thereafter................................................ -- 308 ----- ------ Total minimum lease payments................................ 548 $5,615 ====== Less amount representing interest........................... (15) ----- Present value of future lease payments...................... 533 Less current portion........................................ (533) ----- Non-current portion of capital lease obligations............ $ -- =====
Lines of Credit and Note Payable In July 1999, the Company refinanced its two lines of credit, one with Sumitomo Bank, Limited ("Sumitomo") and one with Sumitomo and Silicon Valley Bank, jointly for a new $30 million revolving line of credit with Foothill Capital Corporation. The initial draw down on this line of credit repaid the previous notes with Sumitomo and Silicon Valley Bank. The balance outstanding at December 31, 1999 was $17 million. The new line is subject to the terms of a security agreement, and is fully secured by the Company's marketable investments. Interest is due on the line monthly and is computed at the reference rate for Wells Fargo Bank, which approximates 8.50% at December 31, 1999. The line is available through July 2002. PPGx, Inc. has an $8 million revolving line of credit, which is guaranteed by PPD, Inc. Interest is accrued monthly and is computed at the LIBOR rate, which approximates 6.8% at December 31, 1999. The amount outstanding on this line as of December 31, 1999 was $6 million. The balance of any unpaid principal and interest is due June 30, 2000. In February 1997, the Company entered into a lending arrangement with one of its facility lessors for tenant improvements. The loan amount was $350,000, with interest accruing at 9% per annum. Principal and interest are due monthly through July 1, 2001. Principal maturities of the lines of credit and note payable at December 31, 1999 are as follows:
(IN THOUSANDS) 2000................................... $23,113 2001................................... 57 ------- $23,170 =======
11. RELATED PARTY TRANSACTIONS In February 1999, the Company entered into an employment agreement with its Chief Executive Officer that extends through January 31, 2003. The agreement provided for compensation and bonus provisions in exchange for continued service and an agreement not to compete. In addition, the agreement provides for 52 53 AXYS PHARMACEUTICALS, INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) forgiveness of a note receivable, totaling $560,000. In addition, the agreement provides for the forgiveness of accrued interest and a partial tax gross-up. The principal portion of the notes forgiven pursuant to the employment agreement and a predecessor employment agreement in 1999, 1998 and 1997 was $160,000, $155,000 and $75,000, respectively. In December 1999, the Company entered into employment agreements with its Sr. Vice President of Research and Preclinical Development and its Sr. Vice President, Corporate and Business Development and General Counsel. These agreements provide for compensation, bonus and stock acceleration in the event of a change in control in exchange for continued service. 12. EMPLOYEE BENEFIT PLAN The Company maintains a 401(K) retirement savings plan for all of its eligible employees. Each participant in the plan may elect to contribute 1% to 20% of his or her annual salary to the plan, subject to statutory limitations. The Company matches 50% of the first 6% of the salary contributed by the employee. The Company's match is done with the Company's stock. The expense charged to operations under this plan for fiscal 1999, 1998 and 1997 was $458,253, $295,180 and $276,000, respectively. 13. SEGMENT INFORMATION The Company operates three segments: (i) drug discovery, through collaborative research agreements and unpartnered programs in oncology, (ii) combinatorial chemistry through it's wholly owned subsidiary, Axys Advanced Technologies (AAT) through the sale of chemical compound libraries, and (iii) other affiliated businesses, which includes PPGx, engaged in pharmacogenomics, and Akkadix which is engaged in agricultural biotechnology. The Company's reportable segments are strategic business units that offer different products and services. They are each managed separately because they perform different services utilizing different and distinct operations. Our other affiliated businesses are self funded. Information as to the operations of drug discovery, AAT, and other affiliated businesses is set forth below based on the nature of the products and services offered. The Company evaluates performance based on several factors, of which the primary financial measure is business segment net income or loss. Revenues for AAT include product sales and license, commitment and protocol fees associated with the respective agreements. Net income for AAT does not include corporate overhead allocations, except for a facilities 53 54 AXYS PHARMACEUTICALS, INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) charge and information systems charge in 1999 and a facilities charge in 1998. The accounting policies of the business segments are the same as those described in the summary of accounting policies (Note 1).
YEAR ENDED DECEMBER 31, --------------------------------- 1999 1998 1997 -------- --------- -------- (IN THOUSANDS) Revenues: Drug discovery.................................. $ 24,084 $ 35,760 $ 20,499 AAT............................................. 13,287 11,662 4,315 Other affiliated businesses..................... 886 -- -- -------- --------- -------- Total consolidated................................ $ 38,257 $ 47,422 $ 24,814 ======== ========= ======== Net income (loss): Drug discovery(1)............................... $(44,899) $(152,846) $(11,294) AAT............................................. 4,007 4,172 327 Other affiliated businesses....................... (7,871) (7,450) -- -------- --------- -------- Total consolidated................................ $(48,763) $(156,124) $(10,967) ======== ========= ======== Assets: Drug discovery.................................. $ 40,916 $ 101,888 $ 70,367 AAT............................................. 9,337 5,137 3,217 Other affiliated businesses....................... 5,481 237 0 -------- --------- -------- Total consolidated................................ $ 55,734 $ 107,262 $ 73,584 ======== ========= ========
- --------------- (1) Includes one-time charges of $6.2 million for restructure costs associated with the winding up of operations at the San Diego facility, and the write-off of Genos in 1999, and $125 million and $0.2 million in acquired in-process research and development recorded in 1998 and 1997, respectively, related to certain acquisitions during those years. Other affiliated businesses represent the results of Akkadix's principal activities, which commenced in 1998 and are included through August 1999, and the results of PPGx's principal activities, which commenced in 1999. 14. INCOME TAXES As of December 31, 1999, the Company had federal and state net operating loss carryforwards of approximately $114,500,000 and $11,100,000, respectively. The Company also had federal and California research and other tax credit carryforwards of approximately $5,800,000 and $2,800,000, respectively. The federal net operating loss and credit carryforwards will expire at various dates beginning in the year 2004 through 2019, if not utilized. The state of California net operating losses will expire at various dates beginning in 2000 through 2004, if not utilized. The utilization of the net operating losses and credits may be subject to a substantial annual limitation due to the "change in ownership" provisions of the Internal Revenue Code of 1986 and similar state provisions. The annual limitation may result in the expiration of net operating losses and credits before utilization. 54 55 AXYS PHARMACEUTICALS, INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) Significant components of the Company's deferred tax assets for federal and state income taxes as of December 31 are as follows:
1999 1998 ------------ ------------ Deferred tax assets: Net operating loss carryforwards...................... $ 39,600,000 $ 26,100,000 Research and other credit............................. 8,600,000 7,200,000 Capitalized research expenses......................... 26,500,000 24,400,000 Fixed asset depreciation.............................. 3,200,000 2,600,000 Other................................................. 4,500,000 2,400,000 ------------ ------------ Total deferred tax assets............................... 82,400,000 62,700,000 Valuation allowance..................................... (82,400,000) (62,700,000) ------------ ------------ Net deferred tax........................................ $ -- $ -- ============ ============
The net valuation allowance increased by approximately $33,100,000 and $4,700,000 during the years ended December 31, 1998 and 1997, respectively. Approximately $1,500,000 of the valuation allowance for deferred tax assets relates to benefits of stock options deductions which, when recognized, will be allocated directly to contributed capital. 15. REVENUES FROM SIGNIFICANT PARTNERS AND CUSTOMERS Major customers, responsible for 10% or more of revenues include drug discovery partners and pharmaceutical and biotechnology companies, which purchase AAT compound libraries. The percentages of sales of each of these major customers to total revenue for the years ended December 31 were as follows:
1999 1998 1997 ---- ---- ---- Customer A.................................................. 31% 14% -- Customer B.................................................. 14% 4% -- Customer C.................................................. 13% 10% -- All Others.................................................. 42% 42% 100% --- --- --- Total............................................. 100% 100% 100% === === ===
16. SUBSEQUENT EVENTS In February 2000 the Company entered into a definitive purchase agreement for the sale of 3.5 million newly issued shares of Axys Pharmaceuticals, Inc. common stock to selected institutional and other accredited investors for approximately $31.5 million in gross proceeds. 55 56 PART III. ITEM 10. DIRECTORS AND EXECUTIVE OFFICERS OF THE REGISTRANT The information required by this item is incorporated by reference from the information under the captions "Proposals to be Voted Upon", "Nominees for Directors" and "Compliance with the Reporting Requirements of Section 16" contained in our definitive proxy statement to be filed no later than April 30, 1999 in connection with the solicitation of proxies for our annual meeting of stockholders to be held May 26, 1999 (the "Proxy Statement"). In addition, the information contained in Part I of this Form 10-K under the caption "Executive Officers of the Registrant" is incorporated herein by reference. ITEM 11. EXECUTIVE COMPENSATION The information required by this item is incorporated by reference from the information under the captions "Compensation of Executive Officers," "Compensation of Non-Employee Directors" and "Employment Agreements and Change-in-Control Arrangements" contained in the Proxy Statement. ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT The information required by this item is incorporated by reference from the information under the caption "Axys Stock Ownership of Beneficial Owners, Directors and Management" contained in the Proxy Statement. ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS The information required by this item is incorporated by reference from the information under the caption "Relationships and Transactions You Should Know About" contained in the Proxy Statement. PART IV. ITEM 14. EXHIBITS, FINANCIAL STATEMENT SCHEDULES AND REPORTS ON FORM 8-K (a)(1) INDEX TO FINANCIAL STATEMENTS The Financial Statements required by this item are submitted in Part II, Item 8 of this report. (2) INDEX TO FINANCIAL STATEMENTS SCHEDULES All schedules are omitted because they are not applicable or the required information is shown in the Financial Statements or in the notes thereto. (3) EXHIBITS
EXHIBIT NUMBER DESCRIPTION OF DOCUMENT - ------- ----------------------- 3.1 Amended and Restated Certificate of Incorporation. Incorporated by reference to Ex. 3.1 filed on Form 10-K filed on March 31, 1998. 3.2 Amended and Restated Bylaws.(1) 3.3 Registrant's Certificate of Designation of Series A Junior Participating Preferred Stock incorporated by reference to Exhibit 99.3 filed on Form 8-K dated October 8, 1998. 4.1 Rights Agreement dated as of October 8, 1998, among the Registrant and ChaseMellon Shareholders Services, LLC, incorporated by reference to Exhibit 99.2 filed on Form 8-K dated October 8, 1998. 4.2 Form of Rights Certificate, incorporated by reference to Exhibit 99.4 filed on Form 8-K dated October 8, 1998.
56 57
EXHIBIT NUMBER DESCRIPTION OF DOCUMENT - ------- ----------------------- 10.1 Registration Rights Agreement, among the Registrant and the other parties therein, dated January 7, 1998. 10.2 1989 Stock Plan, as amended.(2) 10.3 Form of Employee Stock Purchase Plan and Form of Offering Document.(2)(12) 10.4+ 1997 Equity Incentive Plan. Incorporated by reference to Exhibit 10.4 filed on Form 10-Q filed on August 15, 1998. 10.6 Standard Industrial Lease between the Registrant and Shelton Properties, Inc., dated October 15, 1992, with related addenda and amendment.(1) 10.7 Third Amendment to Lease between Registrant and Shelton Properties, Inc., dated March 29, 1994.(4) 10.8 Master Equipment Lease Agreement between the Registrant and Phoenix Leasing Incorporated, dated as of April 12, 1993, with related amendments.(1) 10.11** Research and License Agreement between the Registrant and Amgen Inc., dated May 28, 1993.(1) 10.14 Consent and Waiver between the Registrant, Amgen Inc., and the Whitehead Institute for Biomedical Research, dated May 28, 1993.(1) 10.15** Collaboration Agreement between the Registrant and Pharmacia AB, dated March 29, 1993.(1) 10.16** Project Agreement between the Registrant and Pharmacia AB, dated March 29, 1993.(1) 10.17 Form of Restricted Stock Purchase Agreement.(1)(2) 10.18+ Form of Indemnity Agreement entered into between the Registrant and its officers and directors.(1)(2) 10.19 Stock Bonus Grant Plan.(2)(3) 10.20 Financing Agreement between Hambrecht and Quist Guaranty Finance, L.P., dated March 29, 1994, including Security Agreement and Warrant Purchase Agreement of even date.(4) 10.22+ 1994 Non-Employee Directors' Stock Option Plan, as amended on January 7, 1998. Incorporated by reference to Exhibit 10.22 filed on Form 10-K filed on March 31, 1998. 10.23 Fourth Amendment to Lease dated October 15, 1992 between the Registrant and Shelton Properties, Inc., dated October 1, 1994.(5) 10.24** Collaborative Research and License Agreement between the Registrant and Bayer AG, dated November 28, 1994.(6) 10.25** Research Agreement between the Registrant and Pharmacia AB, dated December 21, 1994.(5) 10.26 Form of Fifth Amendment to Lease dated October 15, 1992 between the Registrant and Shelton Properties, Inc. dated August 28, 1996.(6) 10.27 Master Equipment Lease Agreement between the Registrant and GE Capital, dated August 18, 1995.(6) 10.28** Collaborative Research and License Agreement between the Registrant and Pharmacia AB, dated August 29, 1995.(6) 10.33 Amendment to Agreement dated March 29, 1993 between the Registrant and Kabi Pharmacia AB, dated January 31, 1996.(9) 10.34 First Amendment to Research and License Agreement, dated May 28, 1993, between Registrant and Amgen, Inc., dated February 2, 1996.(9) 10.35 Research Agreement between the Registrant and Pharmacia & Upjohn, Inc., a Delaware corporation, dated February 29, 1996.(9)
57 58
EXHIBIT NUMBER DESCRIPTION OF DOCUMENT - ------- ----------------------- 10.36 Form of Sixth Amendment to Lease dated October 15, 1992 between the Registrant and Shelton Properties, Inc., dated March 29, 1996.(9) 10.37 Financing Agreement between Hambrecht and Quist Guaranty Finance, LLC, dated March 29, 1996, including Security Agreement and Warrant Purchase Agreement of even date.(9) 10.39 Standard Industrial Lease between the Registrant and The Equitable Life Assurance Society of the United States, dated August 5, 1996.(10) 10.42** Research Collaboration and License Agreement between Merck & Co., Inc. and the Registrant, dated November 6, 1996.(7) 10.44 Collaborative Research and License Agreement between SmithKline Beecham Corporation and the Registrant, dated June 27, 1996.(11) 10.52 Expansion Lease by and between Health Science Properties, Inc. and Sequana dated as of November 20, 1995.(15) 10.53** Collaborative Research Agreement dated as of June 30, 1995 by and between Sequana and Corange International, Ltd.(14) 10.54** Collaborative Research Agreement dated as of June 12, 1995 by and between Sequana and Boehringer Ingelheim International GmbH.(14) 10.55+ Form of Indemnification Agreement between the Registrant and its officers and directors.(14) 10.59 Merger Agreement and Plan of Reorganization Agreement between Sequana, Sequana Merger Sub, Inc., NemaPharm, Inc. and the Shareholders of NemaPharm, Inc., dated July 19, 1996.(17) 10.61** Joint Venture Agreement among Sequana Therapeutics, Inc., Memorial Sloan-Kettering Cancer Center and Genos Biosciences, Inc., dated January 29, 1997.(19) 10.62* Amendment to Collaborative Research Agreement of June 12, 1995 between Sequana and Boehringer Ingelheim International GmbH, dated June 19, 1997.(20) 10.63 Second Amendment to Expansion Lease by and between Sequana and Alexandria Real Estate Equities, Inc., dated as of May 20, 1997.(20) 10.64 Agreement and Plan of Merger and Reorganization dated November 2, 1997, by and among the Registrant, Beagle Acquisition Sub, Inc., a California corporation and wholly owned subsidiary of the Registrant and Sequana.(21) 10.67* Collaboration Agreement dated as of October 1997 by and between the Registrant and Bristol-Myers Squibb Company. Incorporated by reference to Exhibit 10-67 filed on Form 10-K filed on March 31, 1998. 10.68* Collaboration Agreement dated as of October 31, 1997 by and between Sequana and Warner-Lambert Company. Incorporated by reference to Exhibit 10-68 filed on Form 10-K filed on March 31, 1998. 10.71 $750,000 Promissory Note, dated September 2, 1997, issued by John P. Walker, to the Registrant. Incorporated by reference to Exhibit 10-71 filed on Form 10-K filed on March 31, 1998. 10.72 Employment Agreement, dated August 29, 1997, by and between John Walker and the Registrant. Incorporated by reference to Exhibit 10-72 filed on Form 10-K filed on March 31, 1998. 10.78 1997 Equity Incentive Plan, dated January 7, 1998.(22) 10.83 Amendment to the Collaborative Research Agreement between Sequana and Corange International Ltd., effective June 30, 1995, dated January 9, 1998.(24)
58 59
EXHIBIT NUMBER DESCRIPTION OF DOCUMENT - ------- ----------------------- 10.84* Amendment No. 2 to the Collaborative Research Agreement between Sequana and Corange International Ltd., dated June 30, 1995, effective February 23, 1998.(24) 10.86 Lease Agreement between Sequana and ARE-John Hopkins Court, LLC, dated as of January 7, 1998.(24) 10.87* Termination of Collaborative Research Agreement between Sequana and Glaxo Wellcome, Inc., effective February 1, 1998.(25) 10.88* Combinatorial Chemistry Agreement between the Registrant and Warner-Lambert Company, dated May 15, 1998.(25) 10.89* Collaboration Agreement by and among the Registrant and its subsidiaries, NemaPharm, Inc. and Sequana, and Roche Bioscience, dated June 1, 1998.(25) 10.90* Amendment dated September 21, 1998 to the Collaboration Agreement between Warner-Lambert Company and Sequana, dated October 31, 1997.(26) 10.91 1997 Non-Officer Equity Incentive Plan.(26) 10.93* Second Amendment to the Research Collaboration and License Agreement between Arris Pharmaceutical Corp. and Merck and Co., Inc., dated November 5, 1998. 10.94* Collaborative Research and License Agreement between the Registrant and Rhone-Poulenc Rorer Pharmaceuticals, Inc., dated December 11, 1998. 10.95* Combinatorial Chemistry Agreement between the Registrant and Rhone-Poulenc Rorer Pharmaceuticals, Inc., dated December 22, 1998. 10.96 Agreement, dated June 11, 1998, by and between William Newell and the Registrant. 10.97 Employment Agreement, dated February 26, 1999, between the John Walker and the Registrant.(27) 10.98 Series A Preferred Stock Purchase Agreement, dated February 2, 1999 by and among Xyris Corporation, Bay City Capital Fund I and the Registrant.(27) 10.99 Third Amendment to Expansion Lease, dated August 24, 1998 between the Registrant and ARE-11099 North Torrey Pines, LLC.(27) 10.100 Fourth Amendment to Expansion Lease, dated March 31, 1999 between the Registrant and ARE-11099 North Torrey Pines, LLC.(27) 10.101 First Amendment to the Research Agreement, dated February 28, 1999 between the Registrant and Pharmacia & Upjohn, Inc.(27) 10.102 Seventh Amendment to Standard Industrial Lease Multi-tenant, dated February 13, 1998, between Shelton Corporation and the Registrant.(27) 10.103 Eighth Amendment to Standard Industrial Lease Multi-tenant, dated November 18, 1998 between Shelton International Holdings, Inc. and the Registrant.(27) 10.104 Ninth Amendment to Standard Industrial Lease Multi-tenant, dated November 18, 1998 between Shelton International Holdings, Inc. and the Registrant.(27) 10.105* Termination of Collaborative Research Agreement, dated February 13, 1999 between Corange International, Ltd. and the Registrant.(27) 10.106* Termination Agreement dated February 5, 1999 between Pharmacia and Upjohn AB and the Registrant.(27) 10.107* Combinatorial Chemistry Agreement between Axys Advanced Technologies, Inc. and Daiichi Pharmaceutical Co., Ltd., signed June 30, 1999.(28) 10.108* Amendment to the Collaboration Agreement between the Sequana and Boehringer Ingelheim GmH, dated June 14, 1999.(28)
59 60
EXHIBIT NUMBER DESCRIPTION OF DOCUMENT - ------- ----------------------- 10.109 Series A Preferred Stock Purchase Agreement dated May 14, 1999, by and among Xyris Corporation, The North American Nutrition & Agribusiness Fund and the Registrant.(28) 10.110 Series A Preferred Stock Purchase Agreement dated May 14, 1999, by and among Xyris Corporation and Missouri Soybean Merchandise Council and the Registrant.(28) 10.111 Fourth Amendment to Expansion Lease between Sequana and ARE -- 11099 North Torrey Pines, LLC, dated March 31, 1999.(28) 10.112* First Amendment to Lease between ARE-JOHN HOPKINS COURT LLC and Sequana, dated December 1, 1998.(28) 10.113** Combinatorial Chemistry Agreement between Axys Advanced Technologies, Inc. and Allergan, Inc., dated September 27, 1999.(29) 10.114** Loan Agreement by and between Axys Pharmaceuticals, Inc. and Foothill Capital Corporation, dated July 26, 1999.(29) 10.115 Warrant to Purchase Common Stock, issued to Reedland Capital Partners, dated July 30, 1999.(29) 10.116 Registration Rights Agreement by and among the Registrant and Reedland Capital Partners, dated July 30, 1999.(29) 10.117 Fifth Amendment to Expansion Lease by and between the Registrant and Alexandria Real Estate Equities, dated October 1999.(29) 10.118* Termination of Collaborative Research and License Agreement between Registrant and Bristol-Myers Squibb Pharmaceutical Research Institute dated December 31, 1999. 10.119* Research Collaboration License Agreement between the Registrant and Merck & Co., Inc. dated November 18, 1999. 10.120* Amendment to the Collaboration Agreement between the Registrant and Warner-Lambert Company dated October 1, 1999. 10.121 Employment Agreement, dated December 14, 1999 between William J. Newell and the Registrant. 10.122 Employment Agreement, dated December 14, 1999 between Michael C. Venuti and the Registrant. 21 Subsidiaries of the Registrant. 23.1 Consent of Ernst & Young LLP. 24.1 Power of Attorney (incorporated in the signature page of this Form 10-K). 27 Financial Data Schedule.
- --------------- + Compensatory Benefit Plan or management contract. * Confidential treatment has been requested with respect to certain portions of this exhibit. ** Confidential treatment has been granted with respect to certain portions of this exhibit. (1) Incorporated herein by reference to the Registration Statement on Form S-1 filed October 5, 1993, as amended thereto (file number 33-69972). (2) Compensation plan. (3) Incorporated herein by reference to the Registration Statement on Form S-8 filed January 31, 1994 (file number 33-69972). (4) Incorporated herein by reference to the Registrant's Report on Form 10-Q for the quarter ended March 31, 1994. (5) Incorporated herein by reference to the Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 1994. 60 61 (6) Incorporated herein by reference to the Registrant's Report on Form 10-Q for the quarter ended September 30, 1995. (7) Incorporated herein by reference to the Registrant's Registration Report on Form 10-K for the fiscal year ended December 31, 1996 (8) Incorporated herein by reference to the Registrant's Current Report on Form 8-K, filed November 13, 1995. (9) Incorporated herein by reference to the Registration Report on Form 10-Q for the quarter ended March 31, 1996. (10) Incorporated herein by reference to the Registration Report on Form 10-Q for the quarter ended September 30, 1996. (11) Incorporated herein by reference to the Registration Statement filed on Form S-3/A filed September 19, 1996 (file number 333-09307). (12) Incorporated by reference to the Registration Statement on Form S-8 filed July 29, 1996 (file number 333-09095). (13) Incorporated by reference to exhibit 10.47 to the Registrant's Report on Form 10-Q for the quarter ended October 31, 1997. (14) Incorporated by reference to exhibits filed with Sequana's Registration Statement on Form S-1, filed June 14, 1995 as amended (Reg. No. 33-93460). (15) Incorporated by reference to exhibits filed with Sequana's Registration Statement on Form S-1, filed February 12, 1996 as amended (Reg. No. 333-01226). (16) Incorporated by reference to exhibit 10.14 to Sequana's Report on Form 10-Q for the quarter ended June 30, 1996. (17) Incorporated by reference to exhibit 10.15 to Sequana's Report on Form 10-Q for the quarter ended September 30, 1996. (18) Incorporated by reference to exhibit 10.16 filed with Sequana's Report on Form 10-K, as amended, for the fiscal year ended December 31, 1996. (19) Incorporated by reference to exhibit 10.17 to Sequana's Report on Form 10-Q for the quarter ended March 31, 1997. (20) Incorporated by reference to exhibit 10.18 to Sequana's Report on Form 10-Q for the quarter ended June 30, 1997. (21) Incorporated by reference to exhibit 4.1 to the Schedule 13D filed by the Registrant on November 12, 1997. (22) Incorporated by reference to Appendix E to the Registrants Registration Statement on Form S-4, filed November 27, 1997. (23) Incorporated herein by reference to the Registrant's Registration Report on Form 10-K for the fiscal year ended December 31, 1997. (24) Incorporated herein by reference to the Registrant's Registration Report on Form 10-Q for the quarter ended March 31, 1998. (25) Incorporated herein by reference to the Registrant's Registration Report on Form 10-Q for the quarter ended June 30, 1998. (26) Incorporated herein by reference to the Registrant's Registration Report on Form 10-Q for the quarter ended September 30, 1998. (27) Incorporated herein by reference to the Registrant's Registration Report on Form 10-Q for the quarter ended March 31, 1999. (28) Incorporated herein by reference to the Registrant's Registration Report on Form 10-Q for the quarter ended June 30, 1999. 61 62 (29) Incorporated herein by reference to the Registrant's Registration Report on Form 10-Q for the quarter ended September 30, 1999. (b) REPORTS ON FORM 8-K None (c) See Exhibits listed under Item 14(a)(3). (d) All schedules are omitted because they are not applicable or the required information is shown in the Financial Statements or in the noted thereto. 62 63 SIGNATURES Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized on the 24th day of February, 2000. AXYS PHARMACEUTICALS, INC. BY: /s/ JOHN P. WALKER ------------------------------------ John P. Walker Chairman and Chief Executive Officer POWER OF ATTORNEY KNOW ALL MEN BY THESE PRESENTS, that each person whose signature appears on the following page constitutes and appoints John P. Walker and Kathleen Stafford, or any of them, his attorneys-in-fact, each with the power of substitution, for him 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 the said attorney-in-fact, or his substitute or substitutes, may do or cause to be done by virtue hereof. 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 indicated on the dates indicated.
SIGNATURE TITLE DATE --------- ----- ---- /s/ JOHN P. WALKER Chief Executive Officer February 24, 2000 - ----------------------------------------------------- and Director John P. Walker (Principal executive officer) /s/ KATHLEEN STAFFORD Senior Vice President and February 24, 2000 - ----------------------------------------------------- Chief Financial Officer Kathleen Stafford (Principal financial and accounting officer) /s/ ANN M. ARVIN, M.D. Director March 6, 2000 - ----------------------------------------------------- Ann M. Arvin, M.D. /s/ VAUGHN M. KAILIAN Director February 24, 2000 - ----------------------------------------------------- Vaughn M. Kailian /s/ DONALD KENNEDY, PH.D. Director February 24, 2000 - ----------------------------------------------------- Donald Kennedy, Ph.D. Director February , 2000 - ----------------------------------------------------- Irwin Lerner /s/ ALAN C. MENDELSON Director February 24, 2000 - ----------------------------------------------------- Alan C. Mendelson /s/ J. LEIGHTON READ, M.D. Director February 24, 2000 - ----------------------------------------------------- J. Leighton Read, M.D.
63
EX-10.118 2 TERMINATION AGREEMENT 1 CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. EXHIBIT 10.118 TERMINATION AGREEMENT THIS TERMINATION AGREEMENT (the "Agreement") is made and entered into effective as of December 31, 1999 (the "Effective Date"), by and between AXYS PHARMACEUTICALS, INC. ("AXYS"), a Delaware corporation, formerly known as Arris Pharmaceutical Corporation, having a place of business at 180 Kimball Way, South San Francisco, CA 94080, and BRISTOL-MYERS SQUIBB COMPANY ("BMS"), a Delaware corporation having a place of business at Route 206 and Province Line Road, Princeton, NJ 08543-4000. Axys and BMS may be referred to herein individually as a "Party" or, collectively, as the "Parties." RECITALS A. The Parties are parties to that certain Collaborative Research and License Agreement entered into by Arris Pharmaceutical Corporation and BMS dated October 24, 1997 (the "Collaboration Agreement"), and they now wish to terminate the Collaboration Agreement as provided in this Agreement. B. Concurrent with the execution of this Agreement, and in partial consideration for terminating the Collaboration Agreement pursuant to the terms of this Agreement and the surviving rights and obligations set forth under the Collaboration Agreement, BMS and Axys Advanced Technologies, Inc.(a subsidiary of Axys) are entering into a Combinatorial Chemistry Agreement (the "Combinatorial Chemistry Agreement"). NOW THEREFORE, the Parties agree as follows: 1. DEFINITIONS. Any capitalized terms used in this Agreement not defined herein shall have the meanings as defined in the Collaboration Agreement. 2. TERMINATION OF AGREEMENT. The Parties agree that Collaboration Agreement is hereby terminated, and that such termination shall be deemed to be a termination by BMS pursuant to the provisions of Section 10.3(i) of the Collaboration Agreement. All the consequences, rights and obligations of the Parties under the Collaboration Agreement based on a termination pursuant to the provisions of Section 10.3(i) of the Collaboration Agreement shall apply, except as otherwise provided in this Agreement. BMS is hereby deemed automatically to have granted to Axys as of the Effective Date all the rights that are to be granted to Axys under Sections 10.5(b) and 10.5(d) of the Collaboration Agreement. 3. TERMINATION OF OBLIGATIONS. The Parties agree that any and all of the following obligations are deemed to have terminated and ceased as of [ * ]: (a) all the Parties' obligations to conduct any further Research work under the Collaboration Agreement; and (b) BMS's obligation to fund the Research pursuant to Section 2.5 of the Collaboration Agreement. Further, 1. 2 the Parties agree that, notwithstanding the provisions of Sections 2.9 and 10.3(i) of the Collaboration Agreement, [ * ] shall have no obligation to [ * ], and any such obligations is hereby waived and terminated. 4. MISCELLANEOUS PROVISIONS. (a) ASSIGNMENTS. Except as expressly provided herein, neither this Agreement nor any interest hereunder nor any surviving right or obligation under the Collaboration Agreement shall be assignable by a Party without the prior written consent of the other; provided, however, that a Party may assign this Agreement and any surviving rights and obligations under the Collaboration Agreement to any Affiliate or to any successor in interest by way of merger, acquisition or sale of all or substantially all of its assets in a manner such that the assignee shall be liable and responsible for the performance and observance of all such Party's duties and obligations hereunder and thereunder. This Agreement and any surviving rights and obligations under the Collaboration Agreement and the Collaboration Agreement shall be binding upon the successors and permitted assigns of the Parties. Any assignment not in accordance with this Section 4(a) shall be void. (b) ENTIRE AGREEMENT OF THE PARTIES; AMENDMENTS. This Agreement, the surviving provisions of the Collaboration Agreement, and the Combinatorial Chemistry Agreement constitute and contain the entire understanding and agreement of the Parties respecting the subject matter hereof and cancel and supersede any and all prior negotiations, correspondence, understandings and agreements between the Parties, whether oral or written, regarding such subject matter. No waiver, modification or amendment of any provision of this Agreement, the surviving provisions of the Collaboration Agreement, and the Combinatorial Chemistry Agreement shall be valid or effective unless made in writing and signed by a duly authorized officer of each Party. (c) APPLICABLE LAW. This Agreement shall be governed by and interpreted in accordance with the laws of the State of New York, USA, applicable to contracts entered into and to be performed wholly within the State of New York, excluding conflict of laws principles. (d) WAIVER. A waiver by either Party of any of the terms and conditions of this Agreement or the surviving provisions of the Collaboration Agreement in any instance shall not be deemed or construed to be a waiver of such term or condition for the future or of any subsequent breach hereof. All rights, remedies, undertakings, obligations and agreements contained in this Agreement the surviving provisions of the Collaboration Agreement shall be cumulative and none of them shall be in limitation of any other remedy, right, undertaking, obligation or agreement of either Party. (e) COUNTERPARTS. This Agreement may be executed simultaneously in any number of counterparts, any one of which need not contain the signature of more than one Party but all such counterparts taken together shall constitute one and the same agreement. [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 2. 3 IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their respective duly authorized officers as of the day and year first above written, each copy of which shall for all purposes be deemed to be an original. AXYS PHARMACEUTICALS, INC. BRISTOL-MYERS SQUIBB COMPANY By: /s/ John P. Walker By /s/ William H. Koster, Ph.D. --------------------------------- ---------------------------------- Name: John P. Walker Name: William H. Koster, Ph.D. ------------------------------- -------------------------------- Title: Chairman Title: Senior Vice President, Applied ------------------------------ Discovery & Exploratory Development Date: 1/14/00 Date: ------------------------------- -------------------------------- [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 3. EX-10.119 3 THIRD AMENDMENT TO AGREEMENT 1 CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. EXHIBIT 10.119 THIRD AMENDMENT TO AGREEMENT This is the third amendment to the Research Collaboration and License Agreement between MERCK & CO., INC., a corporation organized and existing under the laws of New Jersey ("MERCK") and ARRIS PHARMACEUTICAL CORPORATION, a corporation organized and existing under the laws of Delaware, now known as Axys Pharmaceuticals, Inc. ("Axys") made as of November 6, 1996 (the "Agreement"). The purpose of this third amendment is to extend the Research Program Term through November 5, 2000, and to increase the number of FTEs for the period September 1, 1999 through November 5, 2000. 1. In accordance with the provisions of Section 2.8 and Section 5.2(d) of the Agreement and subject to MERCK's right to terminate the Research Program and the Agreement in accordance with Section 8.2, the Research Program Term is extended through November 5, 2000, and the parties agree that [ * ] FTEs will be required during the period September 1, 1999 through November 5, 2000. The FTEs for the period September 1, 1999 through November 5, 1999 shall be payable at an annual rate of [ * ] per FTE. The FTEs for the period November 6, 1999 through November 5, 2000 shall be payable at an annual rate of [ * ] per FTE. 2. Attachment 2.1 setting forth the Research Program is hereby amended to include the additional research work set forth on the attachment to this third amendment. 3. Capitalized terms used and not otherwise defined herein shall have the respective meanings set forth in the Agreement. The Agreement, together with the first amendment dated February 9, 1998, the second amendment dated November 5, 1998 and this third amendment contain the entire understanding of the parties with respect to their subject matter. All express or implied agreements and understandings, either oral or written, heretofore made are expressly merged in and made a part of the Agreement as amended by the first, second and third amendments. All other terms and conditions of the Agreement, as amended, continue in full force and effect. The Agreement and its amendments may be amended, or any term thereof modified, only by a written instrument duly executed by both parties hereto. IN WITNESS WHEREOF, the parties have entered into this Amendment as of 18 November, 1999. MERCK & CO., INC. AXYS PHARMACEUTICAL, INC. BY: /s/ Roger M. Perlmutter, M.D., Ph.D. BY: /s/ John P. Walker ------------------------------------ ------------------------- Roger M. Perlmutter, M.D., Ph.D. John P. Walker Executive Vice President Chairman Worldwide Basic Research Chief Executive Officer And Preclinical Development [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 1. 2 Attachment 2.1 Research Program ATTACHMENT 2.1 RESEARCH PROGRAM The work outlined below, initiated [ * ], will be completed by [ * ]. 1. [ * ] [ * ] 2. [ * ] [ * ] 3. [ * ] [ * ] 4. [ * ] [ * ] 5. [ * ] [ * ] 6. [ * ] [ * ] 7. [ * ] a. [ * ] b. [ * ] c. [ * ] d. [ * ] [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 1. 3 Attachment 2.1 Research Program APPENDIX A [ * ] [ * ] [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 2. 4 Attachment 2.1 Research Program APPENDIX B [ * ] [ * ] [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 3. 5 Attachment 2.1 Research Program APPENDIX C [ * ] [ * ] [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 4. 6 Attachment 2.1 Research Program APPENDIX D [ * ] [ * ] [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 5. EX-10.120 4 AMENDMENT TO THE COLLABORATION AGREEMENT 1 CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. EXHIBIT 10.120 AMENDMENT TO THE COLLABORATION AGREEMENT WARNER-LAMBERT COMPANY AND SEQUANA THERAPEUTICS, INC. OCTOBER 1, 1999 2 AMENDMENT TO THE COLLABORATION AGREEMENT This AMENDMENT TO THE COLLABORATION AGREEMENT (the "Agreement"), effective as of October 1, 1999 (the "Effective Date"), is made by and between WARNER-LAMBERT COMPANY, a Delaware corporation, with a principal place of business at 201 Tabor Road, Morris Plains, New Jersey 07950 ("Warner"), and SEQUANA THERAPEUTICS, INC., a California corporation and a wholly-owned subsidiary of Axys Pharmaceuticals, Inc. ("Axys"), with a principal place of business at 11099 N. Torrey Pines Road, La Jolla, California 92037 ("Sequana"). Sequana and Warner may be referred to herein individually as a "Party" and collectively as the "Parties." BACKGROUND WHEREAS, Sequana and Warner are parties to that certain Collaboration Agreement by and between Sequana and Warner dated October 31, 1997; and WHEREAS, the Parties wish to amend and restate the Collaboration Agreement by, and subject to the terms and conditions of, this Agreement; NOW, THEREFORE, in consideration of the foregoing premises and the mutual promises contained herein, Sequana and Warner hereby agree as follows: 1. DEFINITIONS As used in this Agreement, the following capitalized terms shall have the meanings set forth below. 1.1 "AFFILIATE" means, with respect to a Party, any corporation, association or other entity that directly or indirectly controls, is controlled by or is under common control with such Party. As used in this definition of "Affiliate," the term "control" means direct or indirect beneficial ownership of more than fifty percent (50%) of the voting or income interest in the applicable corporation or other business entity. 1.2 "AGENCY" means the U.S. Food and Drug Administration or any successor entity (the "FDA"), and agencies of other governments of other countries having similar jurisdiction over the development, manufacturing and marketing of pharmaceuticals. 1.3 "ANTISENSE" means a nucleic acid, or a functional analog, derivative or homologue thereof, that (a) is complementary to a segment of DNA of a target Gene or such target Gene's cognate RNA, and (b) upon delivery by any means, alters the transcription, processing, elaboration, RNA expression, or protein production of or by such target Gene. 1.4 "AREA" means either of Bipolar Disorder or Schizophrenia. 1.5 "ARRAY WORK" means all data generated by Sequana resulting from Sequana's use of microarray technology to identify disease and treatment genes (or ESTs) differentially expressed in [ * ], or disease and treatment genes (or ESTs) differentially expressed in [ * ]. [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 1. 3 1.6 "BACKGROUND TECHNOLOGY" shall mean all proprietary inventions, methods, ideas, know-how, data, software, protocols, techniques and information (a) that (i) Sequana Controlled on the Collaboration Effective Date or (ii) Sequana developed prior to the Sequana Research Termination Date independently and outside the scope of this Agreement, and in either case had the right to contribute to the Research Program; and (b) that is necessary for the research, design, development, testing, use, manufacture or sale of Collaboration Products, including, without limitation, all United States and foreign patents and patent applications relating thereto (including, without limitation, all reissues, extensions, substitutions, confirmations, registrations, revalidations, additions, continuations, continuations-in-part, and divisions thereof). 1.7 "BIOINFORMATIONAL DATABASE" means the relational database of all genetic and sample information generated pursuant to the Research Program, and the related genotype sample files. 1.8 "BIPOLAR DISORDER" means bipolar affective disorder, bipolar I disorder, bipolar II disorder and schizoaffective disorder (bipolar subtype). 1.9 "COLLABORATION AGREEMENT" means that certain Collaboration Agreement entered into by and between Sequana and Warner effective as of October 31, 1997. 1.10 "COLLABORATION ASSETS" means the items described in Schedule 1.10. 1.11 "COLLABORATION EFFECTIVE DATE" means October 31, 1997. 1.12 "COLLABORATION PRODUCT" means any of the following if developed by Warner or its Affiliates or Sublicensees: (a) a therapeutic human product, an active ingredient of which is a Compound; (b) a therapeutic product that is a Protein, Gene Therapy, Antisense or Vaccine product that is based upon, derived from or active against a Disease Gene or Disease Gene Product; or (c) a diagnostic, prognostic or pharmacogenetic product in the form of a device, compound, kit or service developed based upon or derived from research involving (in whole or in part) the Current Linkages or the Array Work and conducted prior to [ * ]. 1.13 "COLLABORATION TECHNOLOGY" means all Know-How and Patent Rights conceived of, reduced to practice or otherwise developed solely by a Party or jointly by the Parties pursuant to and during the course of the Research Program, but specifically excluding all Background Technology. 1.14 "COMPOUND" means any molecule with a molecular weight of [ * ] that is identified by Warner or its Affiliates or Sublicensees through application of an assay or animal model developed based on a Disease Gene or Disease Gene Product. 1.15 "CONFIDENTIAL INFORMATION" shall have the meaning ascribed in Section 9.1. 1.16 "CONTINUED RESEARCH PROGRAM" means any program of research and development in the Field conducted by Warner and its Affiliates and Sublicensees after the Effective Date. [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 2. 4 1.17 "CONTROL" or "CONTROLLED" means, with respect to any material, Know-How or intellectual property right, that the Party owns or has a license to such material, Know-How or intellectual property right and has the ability to grant the access, the license, the sublicense or the assignment to such material, Know-How or intellectual property right to the other Party, as provided for herein without violating an agreement with, or infringing any rights of, a Third Party as of the time the Party would be first required hereunder to make such assignment or grant such access, license or sublicense to the other Party. 1.18 "CURRENT LINKAGES" means those candidate linkage sites identified through the Research Program and existing on the Effective Date, [ * ]. 1.19 "DISEASE GENE" means (a) a Gene identified by a Schizophrenia or Bipolar Disorder disease associated haplotype that is sufficiently small to define a single gene product, or (b) a Gene with a mutation which is shown to be genetically associated with Schizophrenia or Bipolar Disorder and is consistent with a Schizophrenia or Bipolar Disorder related biological function, in each case only if identified from the Current Linkages, or identified by Warner (or its Affiliates or Sublicensees) through Warner's (or its Affiliates' or Sublicensees') use of the Array Work, prior to [ * ]. Notwithstanding the foregoing, a Gene, which would otherwise be deemed a Disease Gene under the preceding sentence, shall not be deemed a Disease Gene if at its time of identification by Warner, its Affiliates or its Sublicensees, (i) the sequence of such Gene and its association with Schizophrenia or Bipolar Disorder is in the public domain, or (ii) such Gene already has been publicly proposed by a Third Party to be a target for a disease in the Area. 1.20 "DISEASE GENE MILESTONE" means the milestone described in Section 5.3(b)(i). 1.21 "DISEASE GENE PRODUCT" means any protein product, or fragment thereof, of a Disease Gene, identified at any time during the term of this Agreement. 1.22 "FIELD" means research and drug discovery aimed at identifying human Genes and Gene sequence information for the purpose of discovering compounds, and the development and commercialization of such compounds useful for the treatment of Schizophrenia or Bipolar Disease. 1.23 "FULL TIME EQUIVALENT" or "FTE" means a full-time employee or the equivalent thereof. 1.24 "GENE" means a gene, including without limitation all its regulatory sequences, and any and all variants thereof, including without limitation "splice variants," polymorphisms, alleles and mutations of such gene. 1.25 "GENE THERAPY" means the introduction of a Gene into a person for therapeutic purposes by (a) in vivo introduction for incorporation into cells of such person, or (b) ex vivo introduction into cells for transfer into a person. [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 3. 5 1.26 "IBD TECHNOLOGY" means the technology described in Schedule 1.26 hereto, to the extent that such technology is Controlled by Sequana at the time of Warner's exercise of the IBD Option as described in Section 4.5. 1.27 "IND" means an Investigational New Drug application, as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding foreign application, registration or certification. 1.28 "KNOW-HOW" means all ideas, inventions, data, instructions, processes, formulas, expert opinions and information, including, without limitation, biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical, clinical, safety, manufacturing and quality control data and information, in each case, which are necessary or useful for and are specific to the research, design, development, testing, use, manufacture or sale of Collaboration Products. "Know-How" does not include any inventions included in the Patent Rights. 1.29 "NET SALES" means the gross amount invoiced by Warner or Sequana, or their Affiliates or Sublicensees, as the case may be, for sales to Third Parties (other than Sublicensees) in arm's length transactions of the applicable Collaboration Products and any and all services provided in connection with sales of such Collaboration Products [ * ]. A "sale" shall include any transfer or other disposition for consideration, and Net Sales shall include the fair market value of all other consideration received by the selling Party or its Affiliates or permitted Sublicensees in respect of any grant of rights to make, use, sell or otherwise distribute Collaboration Products, whether such consideration is in cash, payment in kind, exchange or another form. In the case of discounts on "bundles" of products or services which include Collaboration Products, the selling Party may, [ * ] The selling party shall provide the other party documentation, reasonably acceptable to the other party, establishing such average discount with respect to each "bundle." [ * ] 1.30 "NEW DRUG APPLICATION" or "NDA" means a New Drug Application, as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, and any corresponding foreign application, registration or certification. 1.31 "PATENT RIGHTS" means all United States and foreign patents (including all reissues, extensions, substitutions, confirmations, re-registrations, re-examinations, revalidations and patents of addition) and patent applications (including, without limitation, all continuations, continuations-in-part and divisions thereof) in each case, claiming an invention which is necessary or useful for the design, development, testing, use, manufacture or sale of Collaboration Products. 1.32 "PROTEIN" means any of a class of compounds, other than a Compound, composed of a variety of amino acids joined by peptide linkages, including aggregates, hybrids, fragments and analogs thereof, as well as naturally post-translationally modified variants thereof (i.e., glycosylated proteins) and chemically modified versions thereof (e.g., pegylated or liposomally encapsulated proteins). [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 4. 6 1.33 "RESEARCH PROGRAM" shall have the meaning set forth in the Collaboration Agreement. 1.34 "SCHIZOPHRENIA" means schizophrenia, schizoaffective disorder (depressive subtype) and schizophrenic spectrum disorders (schizophreniform disorder, schizotypal disorders and NOS psychotic disorder). 1.35 "SEQUANA COLLABORATION TECHNOLOGY" means all Collaboration Technology that is Controlled by Sequana as of the Effective Date, specifically including the Collaboration Assets, but specifically excluding any Sequana Software. 1.36 "SEQUANA RESEARCH TERMINATION DATE" means the Effective Date or September 30, 1999, whichever is earlier. 1.37 "SEQUANA SOFTWARE" means the Software described in Schedule 1.37. 1.38 "SOFTWARE" means computer code (in source or object form) that is Controlled by Sequana and that, when executed by a digital computer, provides said computer with the capability of manipulating numbers, text and/or graphics in a manner defined by said computer code. 1.39 "SUBLICENSEE" means a Third Party to whom Warner has granted a license or sublicense under the Collaboration Technology to make, have made, import, use, sell, offer for sale or otherwise exploit a Collaboration Product in the Territory. As used in this Agreement, "Sublicensee" shall also include a Third Party to whom Warner has granted the right to distribute the Collaboration Product in the Territory. 1.40 "THIRD PARTY" means any party other than Warner or Sequana or their respective Affiliates. 1.41 "TVS SOFTWARE" means the Target Validation System software described in Schedule 1.37 and all data embedded therein. 1.42 "VACCINE" means a prophylactic or therapeutic agent that acts by inducing a humoral and/or cell-mediated immune response directed against an antigen. 1.43 "VALID CLAIM" means a claim of a pending patent application within the Patent Rights (provided such application has not been pending for more than [ * ] years from the date it was first filed with the governmental agency with jurisdiction over patent applications) or an issued and unexpired patent included within the Patent Rights which has not been held unenforceable or invalid by a court or other governmental agency of competent jurisdiction, and which has not been disclaimed or admitted to be invalid or unenforceable through reissue or otherwise. [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 5. 7 2. AMENDMENT OF THE COLLABORATION AGREEMENT The Parties agree that the Collaboration Agreement is hereby amended in its entirety and restated by this Agreement as of and for the period following the Sequana Research Termination Date, except as otherwise expressly and specifically provided herein. 3. RESEARCH PROGRAM 3.1 TERMINATION OF CURRENT SEQUANA RESEARCH PROGRAM. (a) The Parties hereby agree that Sequana's participation in the Research Program shall end as of the Sequana Research Termination Date, and Warner thereafter shall be entitled to conduct the Continued Research Program, in its sole discretion, subject to the terms set forth herein. (b) Warner shall incur no further financial obligation under Section 5.3 of the Collaboration Agreement after the Sequana Research Termination Date; provided, however, that (i) Warner shall make all payments due to Sequana under Section 5.3 of the Collaboration Agreement through the Sequana Research Termination Date, and (ii) Warner shall pay Sequana for the FTEs used to transfer the Collaboration Assets to Warner as further described in Sections 3.3 and 5.2 of this Agreement. 3.2 CONTINUED RESEARCH PROGRAM. (a) Warner's conduct of the Continued Research Program may, in Warner's sole discretion, include all research and development of the Current Linkages and Array Work by Warner, its Affiliates or its Sublicensees following the Sequana Research Termination Date. Warner shall have no obligation to conduct the Continued Research Program. Neither Party makes any warranty that the Continued Research Program shall achieve any research objectives. (b) After the Sequana Research Termination Date, Warner shall be [ * ] for [ * ] in conducting the Continued Research Program, including, without limitation, the acquisition of any technology or intellectual property rights, in each case, which Warner deems, in its sole discretion, to be necessary or useful for the conduct of the Continued Research Program. It is understood and agreed that Sequana shall [ * ] any activities under the Continued Research Program and shall incur [ * ] with respect thereto, other than [ * ] pursuant hereto. (c) If Warner hires or retains any individual or entity who was employed or retained by (i) Axys or Sequana or (ii) any vendor, contractor, consultant or similar entity retained by Axys or Sequana, which individual or entity performed activities related to the Research Program, Axys and Sequana hereby waive [ * ] applicable to such entity or individual, but only to the extent such restrictions would prevent such entity or individual from [ * ], including [ * ]. [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 6. 8 3.3 TRANSFER OF COLLABORATION ASSETS. Sequana agrees to transfer to Warner all the Collaboration Assets, subject to the terms of this Section 3.3. The Collaboration Assets are transferred by Sequana and accepted by Warner "as is." (a) Sequana shall use [ * ] efforts to transfer to Warner all the Collaboration Assets, other than the [ * ], by [ * ], but Sequana shall transfer such Collaboration Assets to Warner (other than the [ * ]) by a date that is in no event later than [ * ], except that the [ * ] shall be delivered no later than [ * ]. Sequana shall target the transfer of the [ * ] to Warner by [ * ]. (b) Sequana shall use [ * ] efforts to complete the transfer of the [ * ] as soon as is reasonably possible following the Effective Date. (c) Warner shall pay for [ * ] paid to Third Parties for transferring the Collaboration Assets to a Warner-designated location. Sequana shall provide the FTEs designated on Schedule 3.3 in order to effect such transfer, [ * ] in accordance with Section 5.2. 3.4 PATIENT SAMPLE COLLECTION AND OTHER THIRD PARTY COSTS. Sequana will transfer to Warner all patient sample collections that are in its Control and that [ * ], and shall transfer to Warner all other patient sample collections that [ * ] other than the patient sample collection [ * ], as to which Sequana will use [ * ] efforts to transfer such collection to Warner. Sequana will assign to Warner as soon as practicable all right, title and interest in all outstanding Third Party contracts covering the collection of such samples (each such contract, a "Collection Contract"); provided however that Warner acknowledges that the transfer of those samples that are not in Sequana's Control and the assignment hereunder of one or more Collection Contracts may require the consent of Third Parties, and that Sequana may not be able to obtain such consent; and provided further that Sequana shall not be required to make any payments to transfer such samples or assign any Collection Contract to Warner. Notwithstanding the foregoing, Sequana shall make all payments to such Third Parties which are due and owing under such contracts and for which Sequana has been paid by Warner. At Warner's written request, Sequana shall [ * ]. Warner's obligations under Section 2.2.2 of the Collaboration Agreement will continue in full force and effect with respect to each Collection Contract until such time as the assignment of such contract to Warner becomes effective. Following assignment of each Collection Contract, Warner shall be directly responsible for all payments due to a Third Party under such contract. In the event Warner notifies Sequana in writing that it does not desire to assume any particular Collection Contract prior to the assignment thereof to Warner, Sequana will retain the applicable patient samples and terminate such contract; provided that Warner shall be responsible for and reimburse Sequana for [ * ]. 3.5 RECORDS. In accordance with its normal record keeping practices, Warner shall maintain records of its research and development activities relating to Collaboration Products. 3.6 REPORTS. Until the first commercial sale of a Collaboration Product, Warner shall, periodically and not less often than semi-annually during the term of this Agreement, prepare and provide to Sequana, a written statement, signed by the program director for the Continued Research Program or his superior, describing whether any milestones for which [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 7. 9 Sequana is entitled to payment hereunder were achieved, or whether any Collaboration Products have begun development, since the last written report and whether Warner is continuing any research or development efforts under the Continued Research Program. Upon the written request of Sequana from time to time (but not more frequently than once every six months), a financial or other officer of Warner shall certify in writing whether any milestones or other payments are due and owing from Warner hereunder, together with a description, if applicable, in reasonable detail of any such milestones or other payments. 4. TECHNOLOGY TRANSFER 4.1 ASSIGNMENT OF SEQUANA COLLABORATION TECHNOLOGY. (a) Sequana hereby assigns to Warner all of Sequana's right, title and interest to the Sequana Collaboration Technology and intellectual property rights therein. Sequana shall, as reasonably requested by Warner, take all necessary steps to perfect Warner's title to the Sequana Collaboration Technology, at Warner's expense. (b) Sequana shall deliver to Warner, at the time Sequana delivers the Collaboration Assets hereunder, all documents and other materials in Sequana's possession and Control that materially embody the Collaboration Technology. If Warner identifies any documents or other materials embodying the Sequana Collaboration Technology that it reasonably believes may be in Sequana's possession and Control, and requests such documents or materials from Sequana in writing by [ * ], then Sequana shall promptly search for such documents or materials, and may cure any breach of this Section 4.1(b) by delivering to Warner such documents or materials as it may locate as soon as is reasonably practicable. Sequana shall deliver the originals of such documents or materials, if so requested by Warner, to the extent that such originals are reasonably available. If Warner has not identified any documents or other materials embodying the Sequana Collaboration Technology that it reasonably believes may be in Sequana's possession and Control and requested such documents or materials from Sequana in writing by [ * ], then Sequana shall be deemed to have fully delivered all such documents and materials hereunder and shall have no further obligations under this subsection (b). 4.2 LICENSING OF BACKGROUND TECHNOLOGY. Subject to the terms and conditions of this Agreement, Sequana hereby grants to Warner an exclusive (even as to Sequana), worldwide license under Sequana's interest in the Background Technology that was licensed to Warner under the Collaboration Agreement as of the Effective Date, with the right to sublicense, to the extent necessary for Warner (a) to conduct the Continued Research Program, (b) make, have made, use and import Compounds and (c) to make, have made, use, import, offer for sale and sell Collaboration Products. 4.3 SEQUANA SOFTWARE. (a) LICENSE. Subject to the terms and conditions of this Agreement, Sequana hereby grants to Warner a non-exclusive, nontransferable, worldwide, royalty-free license, without the right to sublicense except to its Affiliates and collaborative partners, to the Sequana Software, to use and duplicate and to make derivative works of the Sequana Software, in each case, solely to conduct internal research pursuant to the Continued Research Program. Sequana [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 8. 10 shall provide Warner with a copy of all such Software, in object code or, to the extent available, source code format as requested by Warner. (b) TVS SOFTWARE. Sequana shall provide Warner with such documentation, if any, relating to the TVS Software that is in Sequana's possession as of the Effective Date solely for use pursuant to subsection (a) above. In the event that during the [ * ] period following the Effective Date, Sequana makes any upgrades or bug fixes to its internal version of the TVS Software, then Sequana shall provide to Warner, without additional charge, such bug fixes or upgrades to the TVS Software in the form in which such upgrades are developed; it being understood that Sequana shall have no obligation to develop or make any such upgrades or bug fixes or any other changes to such TVS Software or any other Software existing as of the Effective Date. The TVS Software shall be available to Warner in object and/or source code form and shall include any source code for tools developed for the transfer of the data to and from TVS, as requested by Warner. Sequana shall be responsible for transferring all Research Program data, from the instance of the TVS Software used in [ * ] to the instance of the TVS Software which is [ * ]. 4.4 NO IMPLIED LICENSES, RESERVATION OF RIGHTS. No rights or licenses with respect to any intellectual property owned by Sequana or Warner are granted or shall be deemed granted hereunder or in connection herewith, other than those rights expressly granted in Sections 4.1, 4.2 and 4.3. Sequana hereby reserves all rights to such intellectual property, other than as expressly set forth in Sections 4.1, 4.2 and 4.3 above, including without limitation the right to freely use, assign, transfer, grant licenses thereunder and otherwise dispose of such intellectual property for any purpose consistent with the terms of this Agreement. 4.5 IBD OPTION. (a) Sequana hereby grants to Warner an exclusive, non-transferable option to acquire [ * ] (the "IBD Option"), subject to the terms and conditions of this Section 4.5. (b) The IBD Option may be exercised by Warner at any time during the period from the Effective Date through [ * ] by providing Sequana with written notice that Warner is exercising the IBD Option. If Warner exercises the IBD Option as described in this subsection (b), then as soon as reasonably possible following such exercise date: (i) The Parties shall agree upon a reasonable mechanism and schedule for the [ * ] in light of Sequana's need to obtain the consents and cooperation of certain Third Parties in connection with [ * ]; and (ii) Sequana shall use [ * ] efforts to obtain such consents and cooperation from third parties necessary to [ * ], and shall [ * ]. Upon [ * ] as described in subsections (i) and (ii) above, Warner shall pay Sequana an exercise fee of [ * ] in exchange for such [ * ], and Sequana shall be deemed to have [ * ]. In the event Warner refuses to pay Sequana the exercise fee (in whole or in part) because [ * ] in Warner's reasonable judgment, Warner shall provide Sequana, upon its written request, with a listing (in reasonable detail) of the [ * ], and the Parties shall work cooperatively to [ * ]. [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 9. 11 In the event that Warner elects to [ * ], and Sequana shall have no further obligations to Warner under this Section 4.5. (c) In the event that Warner does not exercise the IBD option as described in subsection (b) above by [ * ], the IBD option shall expire, and Sequana thereafter shall have no further obligations to Warner under this Section 4.4. (d) Sequana covenants that, after the Effective Date and prior to [ * ], it shall not [ * ]. Sequana further represents and warrants that [ * ]. 5. CONSIDERATION 5.1 TECHNOLOGY TRANSFER FEE. In partial consideration for the rights granted and materials transferred to Warner herein, Warner shall pay to Sequana a non-creditable, non-refundable technology transfer fee of [ * ]. Such amount shall be paid to Sequana [ * ]. The first such payment shall be paid [ * ], and the second such payment shall be paid [ * ]. 5.2 FTE-BASED PAYMENTS. (a) With respect to the transfer of the Collaboration Assets other than the Bioinformational Database, Warner shall pay Sequana [ * ] as reimbursement for the work of the [ * ] FTEs described in Schedule 3.3 through [ * ], subject to subsection (c) below. Such amount shall be Warner's sole payment obligation with respect to the FTEs used to transfer such Collaboration Assets, regardless of whether such FTEs continue to work to transfer such Collaboration Assets beyond [ * ], except as provided in Section 5.2(b). (b) With respect to the pre-transfer preparation and transfer of the Bioinformational Database and the TVS Software, Warner shall pay to Sequana a monthly fee of [ * ] per FTE used for such work after [ * ] and prior to [ * ], and Warner shall promptly reimburse Sequana for all consultants used in such work; provided that no consultant time after [ * ] shall be paid for by Warner unless otherwise agreed by the Parties. Sequana shall use no less than [ * ] and no more than [ * ] FTEs and/or individual consultants at a time to effect such transfer unless otherwise agreed in writing by Warner. Promptly after each of [ * ], Sequana shall provide Warner with time documentation comparable to that provided in the Research Program with respect to all such FTEs being paid for by Warner and shall provide Warner with copies of the bills it receives from the consultants it uses to effectuate such transfer. (c) If, during a particular month, a FTE ceases its activities with respect any of the foregoing services, or a FTE is removed from the performance of such services, then Warner shall only be responsible for the pro rata portion of such monthly fee for such FTE with respect to such month. Sequana shall invoice Warner monthly with respect to such FTE costs, providing reasonable detail, and Warner shall pay such invoices within [ * ] of receipt. 5.3 MILESTONES. (a) GENERAL. The Parties jointly shall be responsible for determining in good faith when and if each of the milestone events described in subsections (b) and (c) below has [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 10. 12 occurred. In the event the Parties cannot agree whether a milestone event has occurred after a period of thirty (30) days, the decision will be referred to the Chief Executive Officer of Sequana and Warner's President of its Parke-Davis Pharmaceutical Research Division for good faith resolution for a period of thirty (30) days. In the event that such individuals are unable to resolve such dispute during such 30 day period, subject to Section 13.1, either Party may thereafter pursue any remedies it may have at law or in equity. (b) [ * ]. (i) Within thirty (30) days of each and every occurrence of the milestone event set forth below (the "[ * ]"), Warner will pay to Sequana the indicated non-refundable, non-creditable milestone payment: Milestone Amount --------- ------ [ * ] [ * ] (c) [ * ]. If any Disease Gene is identified prior to [ * ], then within thirty (30) days following the occurrence of the relevant events specified below, Warner shall pay to Sequana for a Collaboration Product which is [ * ], the indicated non-refundable, non-creditable milestone amounts: Milestones Amount ---------- ------ [ * ]. [ * ] [ * ]. [ * ] [ * ]. [ * ] [ * ]. [ * ] [ * ]. [ * ] In no event shall any of the milestone payments set forth in this subsection (c) be paid more than [ * ] with respect to each of Schizophrenia and Bipolar Disorder. The payment due under this subsection (c) shall be made with respect to each applicable Collaboration Product; provided, however, that [ * ]. 5.4 ROYALTIES. (a) COLLABORATION PRODUCT ROYALTIES. In consideration of the rights granted hereunder, Warner shall pay the following royalties to Sequana with respect to annual aggregate Net Sales of Collaboration Products, on a Collaboration Product-by-Collaboration Product basis: [ * ] [ * ] [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 11. 13 (b) COMPUTATION OF ROYALTIES. All sales of Collaboration Products between Warner and any of its Affiliates and Sublicensees shall be disregarded for purposes of computing Net Sales and royalties under this Section 5.4, and in such instances royalties shall be payable only upon sales to unlicensed Third Parties. Nothing herein contained shall obligate Warner to pay Sequana more than one royalty payment on any unit of a Collaboration Product. (c) ROYALTY TERM. The obligation of Warner to pay royalties under this Section 5.4 shall continue for each Collaboration Product on a product-by-product and country-by-country basis, until such time as there are no Valid Claims in such country covering such Collaboration Product. 5.5 THIRD PARTY ROYALTIES. [ * ] shall be responsible for the payment of any royalties, license fees and milestone and other payments due to any other Third Party(ies) under licenses or similar agreements entered into by [ * ], which are necessary or useful for the manufacture, use, import, or sale of Collaboration Products. 5.6 WITHHOLDING TAXES. Any income or other tax that Warner, its Affiliates or Sublicensees is required to withhold and pay on behalf of Sequana with respect to the royalties payable under this Agreement shall be deducted from and offset against said royalties prior to remittance to Sequana; provided, however, that in regard to any tax so deducted, Warner shall give or cause to be given to Sequana such assistance as may reasonably be necessary to enable Sequana to claim exemption therefrom or credit therefor, and in each case shall furnish Sequana proper evidence of the taxes paid on its behalf. 6. BOOKS AND RECORDS 6.1 ROYALTY REPORTS AND PAYMENTS. The royalties due under Section 5.4 shall be paid quarterly, within sixty (60) days after the close of each calendar quarter, or earlier, if practical, immediately following each quarterly period in which such royalties are earned. With each such quarterly payment, Warner shall furnish Sequana a royalty statement setting forth, on a country-by-country and Collaboration Product-by-Collaboration Product basis, the total number of units of each royalty bearing Collaboration Product sold hereunder for the quarterly period for which the royalties are due. Simultaneously with the delivery of each such report, Warner shall pay to Sequana the total royalties, if any, due to Sequana for the period of such report. If no royalties are due, Warner shall so report. In addition, at Sequana's request, but no more often than once in any twelve (12) month period, Warner shall report to Sequana on a country-by-country and Collaboration Product-by-Collaboration Product basis the amounts of any deductions and/or adjustments to Net Sales taken by Warner pursuant to Section 1.30 with respect to Net Sales in the preceding four (4) calendar quarters. 6.2 PAYMENT METHOD; LATE PAYMENTS. All amounts due Sequana hereunder shall be paid in U.S. dollars by wire transfer in immediately available funds to a bank account designated by Sequana. Any payments or portions thereof due hereunder which are not paid on the date such payments are due under this Agreement shall bear interest at a rate equal to the lesser of prime rate as reported by the Citibank (or its successor in interest), New York, New York, plus two percent (2%), or the maximum rate permitted by law, calculated on the number of days such [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 12. 14 payment is delinquent, compounded monthly. This Section 6.2 shall in no way limit any other remedies, in law or equity, available to Sequana. 6.3 CURRENCY CONVERSION. Royalties earned shall first be determined in the currency of the country in which they are earned and then converted to its equivalent in United States currency. The buying rates of exchange for converting the currencies involved into the currency of the United States quoted by Citibank (or its successor in interest) New York, New York at the close of business on the last business day of the quarterly period in which the royalties were earned shall be used to determine any such conversion. 6.4 RESTRICTIONS ON PAYMENTS. The obligation to pay royalties under this Agreement shall be waived and excused to the extent that statutes, laws, codes or government regulations in a particular country prevent such royalty payments; provided, however, in such event, if legally permissible, Warner shall pay the royalties owed to Sequana by depositing such amounts in a bank account in such country that has been designated by Sequana and promptly report such payment to Sequana. 6.5 RECORDS; INSPECTION. Warner and its Affiliates shall keep (and cause its Sublicensees to keep) complete, true and accurate books of account and records for the purpose of determining the royalty amounts payable under Section 5.4. Such books and records shall be kept reasonably accessible for at least three (3) years following the end of the calendar quarter to which they pertain. Such records will be open for inspection during such three (3) year period by a representative or agent of Sequana reasonably acceptable to Warner, which approval shall not be unreasonably withheld for the purpose of verifying the royalty statements. Such inspections may be made no more than once each calendar year, at reasonable times mutually agreed by Warner and Sequana. Sequana's representative or agent will be obliged to execute a reasonable confidentiality agreement prior to commencing any such inspection and may only disclose to Sequana the amount of any variance or error. Sequana shall bear the costs and expenses of inspections conducted under this Section 6.5, unless a variation or error producing an underpayment in royalties payable exceeding [ * ] of the amount payable for any inspection period is established in the course of any such inspection, whereupon all costs relating to the inspection and any unpaid amounts that are discovered will be paid by Warner, together with interest on such unpaid amounts at the rate specified in Section 6.2 above. 7. COMMERCIALIZATION 7.1 PRODUCT DEVELOPMENT. Warner shall be responsible for all costs of conducting and shall have the sole and exclusive right to conduct, in its sole discretion, such development of Collaboration Product(s) as Warner may choose to do, including, without limitation, conducting clinical trials, under its own IND, and paying for all expenses incurred by it in conducting clinical trials for such Collaboration Products. In addition, Warner shall be responsible, at its sole expense, for all commercialization of and shall have the sole and exclusive right to conduct, in its sole discretion, commercialization of such Collaboration Products throughout the world as Warner may choose to do. [ * ] [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 13. 15 8. REPRESENTATIONS AND WARRANTIES 8.1 LEGAL AUTHORITY. Each Party represents and warrants to the other that it has the legal power, authority and right to enter into this Agreement and to perform its respective obligations set forth herein. 8.2 NO CONFLICTS. Each Party represents and warrants that as of the Effective Date it is not a party to any agreement or arrangement with any Third Party or under any obligation or restriction, including pursuant to its Certificate of Incorporation or Bylaws, which in any way limits or conflicts with its ability to fulfill any of its obligations under this Agreement, and shall not enter into any such agreement during the term of this Agreement. 8.3 SEQUANA REPRESENTATIONS. Sequana represents and warrants to Warner as follows: (a) From the Collaboration Effective Date, Sequana [ * ]; and (b) As of the Effective Date, Sequana Controls the Sequana Software. 8.4 DISCLAIMER OF WARRANTIES. Sequana and Warner each specifically disclaim that the research and development of Collaboration Products will be successful, in whole or part. SEQUANA AND WARNER EXPRESSLY DISCLAIM ANY WARRANTIES OR CONDITIONS, EXPRESS, IMPLIED, STATUTORY OR OTHERWISE, WITH RESPECT TO THE BACKGROUND TECHNOLOGY, COLLABORATION TECHNOLOGY OR COLLABORATION COMPOUNDS INCLUDING, WITHOUT LIMITATION, ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, VALIDITY OF ANY BACKGROUND TECHNOLOGY, COLLABORATION TECHNOLOGY, PATENTED OR UNPATENTED, OR NON-INFRINGEMENT OF THE INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES. 9. CONFIDENTIALITY 9.1 CONFIDENTIAL INFORMATION. Except as expressly provided herein, the Parties agree that the receiving Party shall keep completely confidential and shall not publish or otherwise disclose and shall not use for any purpose except for the purposes contemplated by this Agreement: (a) in the case where Warner is the receiving Party, any Sequana Background Technology, or any other data, samples, technical and economic information (including the economic terms hereof), commercialization, clinical and research strategies and know-how and other information provided to Warner by Sequana (Sequana in such case to be the "Disclosing Party") in connection with either this Agreement or the Collaboration Agreement, other than the Collaboration Technology and the IBD Technology transferred to Warner pursuant hereto; and (b) in the case where Sequana is the receiving party, any Collaboration Technology and all other data, results and information developed pursuant to the Research Program or the Continued Research Program and solely owned by Warner, and any other data, samples, technical and economic information (including the economic terms hereof), commercialization, clinical and research strategies and know-how and other information provided to Sequana by Warner (Warner in such case to be the "Disclosing Party") in connection with either this Agreement or [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 14. 16 the Collaboration Agreement ((a) and (b) collectively, the "Confidential Information"). Notwithstanding the preceding sentence, the Parties agree that all confidential or proprietary information pertaining to the Research Program and assigned to Warner hereunder shall be deemed to be Warner's Confidential Information for purposes of this Agreement. "Confidential Information" shall not include: (i) information that is or becomes part of the public domain through no wrongful act of the non-Disclosing Party or its Affiliates; and (ii) information that is obtained after the date hereof by the non-Disclosing Party or one of its Affiliates from any Third Party which is lawfully in possession of such Confidential Information and not in violation of any contractual or legal obligation to the Disclosing Party with respect to such Confidential Information; (iii) information that is known to the non-Disclosing Party or one or more of its Affiliates prior to disclosure by the Disclosing Party, as evidenced by the non-Disclosing Party's written records; and (iv) information that is necessary to be disclosed to any governmental authorities or pursuant to any regulatory filings, but only to the limited extent and for the sole purpose of such legally required disclosure, and provided that (A) the non-Disclosing Party notifies the Disclosing Party reasonably in advance so that the Disclosing Party may seek a protective order for such Confidential Information, and (B) the non-Disclosing Party cooperates fully with the Disclosing Party in such efforts; or (v) information which has been independently developed by the non-Disclosing Party without the aid or use of any Confidential Information. 9.2 PERMITTED DISCLOSURES. Confidential Information may be disclosed to employees, agents, consultants, sublicensees or suppliers of the non-Disclosing Party or its Affiliates, but only to the extent reasonably required to accomplish the purposes of this Agreement and only if the non-Disclosing Party obtains prior written agreement from its employees, agents, consultants, sublicensees or suppliers to whom disclosure is to be made to hold in confidence and not make use of such information for any purpose other than those permitted by this Agreement. Each Party will use at least the same standard of care as it uses to protect proprietary or confidential information of its own to ensure that such employees, agents, consultants, sublicensees or suppliers do not disclose or make any unauthorized use of the Confidential Information. Notwithstanding any other provision of this Agreement, each Party may disclose the terms of this Agreement to prospective lenders, investment bankers and other financial institutions of its choice solely for purposes of financing the business operations of such Party either (a) upon the written consent of the other Party or (b) if the disclosing Party obtains a signed confidentiality agreement with such entity or financial institution with respect to such information, upon terms substantially similar to those contained in this Article 9. 9.3 PUBLICITY. All publicity, press releases and other announcements relating to this Agreement or the modifications to the Collaboration Agreement contemplated hereby shall be reviewed in advance by, and shall be subject to the approval of, both Parties; provided, however, [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 15. 17 that either Party may (a) publicize the existence and general subject matter of this Agreement without the other Party's approval, and (b) disclose the terms of this Agreement only to the extent required to comply with applicable securities laws, and in the case of (b), the non-Disclosing Party shall have the right to review and comment on such disclosure prior to its submission, where practicable. Once a particular disclosure described in (a) has been approved for disclosure, either Party may make disclosures which do not differ materially therefrom without any need for further consents. Notwithstanding the foregoing, Warner shall have an unrestricted right to publish any information regarding the status or results of the Continued Research Program or other activities regarding development and/or commercialization of any and all Collaboration Products, provided that Warner shall not disclose any of Sequana's Confidential Information. 9.4 TERM OF CONFIDENTIALITY. All obligations of confidentiality and non-use imposed upon the Parties under this Agreement shall continue indefinitely until such time as the information that is subject to such obligations no longer comprises Confidential Information under one of the exceptions set forth in Section 9.1. 10. RELEASE OF CLAIMS 10.1 MUTUAL RELEASE. (a) Effective upon the Sequana Research Termination Date, Warner hereby forever generally and completely releases and discharges Sequana and its servants, agents, directors, officers and employees, of and from any and all claims and demands of every kind and nature, in law, equity or otherwise, known and unknown, suspected and unsuspected, disclosed and undisclosed, and in particular, of and from all claims and demands of every kind and nature, known and unknown, suspected and unsuspected, disclosed and undisclosed, for damages actual and consequential, past, present and future, arising out of or in any way related to the Parties' respective obligations, activities and/or dealings with one another pursuant to the Collaboration Agreement prior to such date, but excluding from the foregoing (i) any claims or demands arising out of or in any way related to claims for breach of those provisions of the Collaboration Agreement relating to (1) obligations of confidentiality, (2) limitations on use of the Background Technology (as defined in the Collaboration Agreement) or of the Collaboration Technology (as defined in the Collaboration Agreement) or (3) the provisions contained in Sections 2.6 and 4.6, the second sentence of Section 15.7 or the second sentence of Section 15.12 of the Collaboration Agreement; or (ii) claims asserted by Third Parties, including claims by Warner arising out of claims asserted by Third Parties. (b) Effective upon the Sequana Research Termination Date, Sequana hereby forever generally and completely releases and discharges Warner and its servants, agents, directors, officers and employees, of and from any and all claims and demands of every kind and nature, in law, equity or otherwise, known and unknown, suspected and unsuspected, disclosed and undisclosed, and in particular of and from all claims and demands of every kind and nature, known and unknown, suspected and unsuspected, disclosed and undisclosed, for damages actual and consequential, past, present and future, arising out of or in any way related to the Parties' respective obligations, activities and/or dealings with one another pursuant to the Collaboration Agreement prior to such date, but excluding from the foregoing any claims or demands arising [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 16. 18 out of or in any way related to: (i) any claims or demands arising out of or in any way related to claims for breach of those provisions of the Collaboration Agreement relating to (1) obligations of confidentiality, (2) limitations on use of the Background Technology (as defined in the Collaboration Agreement) or of the Collaboration Technology (as defined in the Collaboration Agreement) or (3) the provisions contained in Sections 2.6 and 4.6, the second sentence of Section 15.7 or the second sentence of Section 15.12 of the Collaboration Agreement; (ii) any claims asserted by Third Parties, including claims by Sequana arising out of claims asserted by Third Parties; (iii) all payments due to Sequana under Section 5.3 of the Collaboration Agreement up to and including the Sequana Research Termination Date; and (iv) all patient sample collection reimbursement payments due to Sequana pursuant to Section 2.2.2 of the Collaboration Agreement prior to the effective date that each applicable patient sample collection agreement is assigned to Warner pursuant to Section 3.4 of this Agreement. (c) It is understood and agreed that the release set forth in subsection (a) above, in the case of Warner, and subsection (b) above, in the case of Sequana, is a full, complete and final general release of any and all claims described as aforesaid, and each Party agrees that such release shall apply to all unknown, unanticipated, unsuspected and undisclosed claims, demands, liabilities, actions or causes of action, in law, equity or otherwise, as well as those which are now known, anticipated, suspected or disclosed. (d) Each Party has been fully advised by its respective attorney of the contents of section 1542 of the Civil Code of the State of California, and that section and the benefits thereof, and of any equivalent law or rule in any other applicable jurisdiction, are hereby expressly waived. Section 1542 reads as follows: "Section 1542. (General Release - Claims Extinguished.) A general release does not extend to claims which the creditor does not know or suspect to exist in his favor at the time of executing the release, which if known by him must have materially affected his settlement with the debtor." 10.2 PERIOD OF EFFECTIVENESS. For the avoidance of doubt, the Parties acknowledge and agree that the releases set forth in Section 10.1 above are effective only as to claims, demands, liabilities, actions or causes of action, in law, equity or otherwise, whenever made, arising out of or related to the activities of the Parties pursuant to the Collaboration Agreement prior to the Sequana Research Termination Date, and shall be of no force and effect with respect to any other claims, demands, liabilities, actions or causes of action, in law, equity or otherwise, including without limitation those arising out of or in any way related to this Agreement. 11. INDEMNIFICATION 11.1 WARNER. Warner hereby agrees to defend, indemnify and hold harmless Sequana and its Affiliates and their respective employees, agents, officers, directors and permitted assigns (each a "Sequana Indemnitee") from and against any claims by a Third Party resulting in any liabilities, damages, settlements, claims, actions, suits, penalties, fines, costs or expenses incurred (including, without limitation, reasonable attorneys' fees and other expenses of litigation) (any of the foregoing, a "Claim") arising out of or resulting from (a) negligence or willful misconduct by Warner; (b) a breach of any of the representations or warranties of Warner [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 17. 19 under this Agreement; or (c) the research and development, manufacture, use, promotion, marketing, sale or other distribution of any Collaboration Product, or any use or disposition of the Collaboration Technology, by Warner or its Affiliates or Sublicensees, except, in each case, to the extent that such Claim arises out of or results from the negligence or willful misconduct of any Sequana Indemnitee. 11.2 SEQUANA. Sequana agrees to defend, indemnify and hold harmless Warner and its Affiliates and their respective employees, agents, officers, directors and permitted assigns (each a "Warner Indemnitee") from and against any claims by a Third Party resulting in any liabilities, damages, settlements, claims, actions, suits, penalties, fines, costs or expenses incurred (including, without limitation, reasonable attorneys' fees and other expenses of litigation) (any of the foregoing, a "Claim") arising out of or resulting from (a) the negligence or willful misconduct of Sequana, or (b) a breach of any of the representations or warranties of Sequana under this Agreement, (c) Sequana's conduct of the Research Program prior to the Sequana Research Termination Date, except, in each case, to the extent that such Claim arises out of or results from the negligence or willful misconduct of any Warner Indemnitee. 11.3 PROCEDURE. A Party or person (the "Indemnitee") that intends to claim indemnification under this Article 11 shall promptly notify the other Party (the "Indemnitor") in writing of any loss, claim, damage, liability or action in respect of which the Indemnitee or any of its Affiliates, or their directors, officers, employees, agents or counsel intend to claim such indemnification, and the Indemnitor shall have the right to participate in, and, to the extent the Indemnitor so desires, to assume sole control over the defense and settlement thereof with counsel chosen by Indemnitor, with consent of Indemnitee, which consent shall not be unreasonably withheld. The failure to deliver written notice to the Indemnitor within a reasonable time after the commencement of any such action, if prejudicial to its ability to defend such action, shall relieve such Indemnitor of any liability to the Indemnitee under this Article 11. At the Indemnitor's request, the Indemnitee under this Article 11, and its employees and agents, shall cooperate fully with the Indemnitor and its legal representatives in the investigation and defense of any action, claim or liability covered by this indemnification and provide full information with respect thereto. 12. TERM AND TERMINATION 12.1 TERM. This Agreement shall be effective as of the Effective Date and, unless otherwise terminated earlier pursuant to the other provisions of this Article 12, shall continue in full force and effect on a Collaboration Product-by-Collaboration Product and country-by-country basis until the date that neither Warner nor its Affiliates or Sublicensees has any remaining royalty obligations to Sequana in such country under this Agreement. 12.2 TERMINATION FOR CAUSE. Either Party may terminate this Agreement in the event the other Party has materially breached or defaulted in the performance of any of its obligations hereunder, and such default has continued for sixty (60) days after written notice thereof was provided to the breaching Party by the nonbreaching Party, or if a cure of such default cannot reasonably be effected within such sixty (60) day period, the defaulting Party has failed to deliver within such period a plan for curing such breach or default which is reasonably sufficient to effect a cure. Any termination shall become effective at the end of such sixty (60) day period [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 18. 20 unless the breaching Party has cured any such breach or default prior to the expiration of the sixty (60) day period, or has delivered to the other Party a plan for curing such breach which is reasonably acceptable to the other Party. Notwithstanding the above, in the case of a failure to pay any amount due hereunder, the period for cure of any such default following notice thereof shall be ten (10) days and, unless payment is made within such ten day period, the termination shall become effective at the end of such period. 12.3 EFFECT OF TERMINATION. (a) ACCRUED RIGHTS AND OBLIGATIONS. Termination of this Agreement for any reason shall not release any Party hereto from any liability which, at the time of such termination, has already accrued to the other Party or which is attributable to a period prior to such termination, nor preclude either Party from pursuing any rights and remedies it may have hereunder or at law or in equity which accrued or are based upon any event occurring prior to such termination. (b) RETURN OF CONFIDENTIAL INFORMATION. Upon any termination of this Agreement, Warner and Sequana shall promptly return to the other Party all Confidential Information received from the other Party (except one copy of which may be retained by legal counsel solely for purposes of monitoring compliance with the provisions of Article 9 and archival purposes). (c) LICENSES. In the event of any termination of this Agreement by Sequana pursuant to Section 12.2, the licenses granted Warner in Article 4 shall terminate concurrently. 12.4 SURVIVAL. Sections 6.5, 12.3 and 12.4 and Articles 7, 8, 9, 10, 11, 13 and 14 shall survive the expiration or termination of this Agreement for any reason. 13. DISPUTE RESOLUTION 13.1 MEDIATION. If a dispute arises out of or relates to this Agreement, or the breach thereof, and if said dispute cannot be settled through negotiation, the Parties agree first to try in good faith to settle the dispute by mediation under the Commercial Mediation Rules of the American Arbitration Association, before resorting to arbitration, litigation, or some other dispute resolution procedure. 13.2 VENUE. The exclusive venue of any dispute arising out of or in connection with the performance of or any breach of this Agreement, shall be the state courts or U.S. District Court located in or for Sequana's principal place of business, and the Parties hereby irrevocably consent to the personal jurisdiction of such courts. 14. MISCELLANEOUS 14.1 GOVERNING LAW. This Agreement and any dispute arising from the performance or any breach hereof shall be governed by and construed in accordance with the laws of the State of New York, as such laws are applied to agreements entered into between residents of, and to be performed entirely within, the State of New York. [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 19. 21 14.2 WAIVER. No failure on the part of Sequana or Warner to exercise and no delay in exercising any right under this Agreement, or provided by statute or at law or in equity or otherwise, shall impair, prejudice or constitute a waiver of any such right, nor shall any partial exercise of any such right preclude any other or further exercise thereof or the exercise of any other right. 14.3 ASSIGNMENT. This Agreement may not be assigned by either Party to any Third Party hereto without the written consent of the other Party hereto; except either Party may assign this Agreement, without such consent, to (a) an Affiliate of such Party; or (b) an entity that acquires all or substantially all of the business or assets of such Party (or with respect to Warner, all of Warner's pharmaceutical research and development business or assets) to which this Agreement pertains, whether by merger, reorganization, acquisition, sale, or otherwise. The terms and conditions of this Agreement shall be binding on and inure to the benefit of the permitted successors and assigns of the Parties. Any assignment not in conformance with this Section 14.3 shall be null, void and of no legal effect. 14.4 NOTICES. All notices, requests and other communications hereunder shall be in writing and shall be personally delivered or sent by nationally recognized overnight express delivery service, registered or certified mail, return receipt requested, postage prepaid, in each case to the respective address specified below, or such other address as may be specified in writing to the other Parties hereto: Warner: Warner-Lambert Company 2800 Plymouth Road Ann Arbor, Michigan 48105 Attn: President Parke-Davis Pharmaceutical Research with a copy to: Warner-Lambert Company 201 Tabor Road Morris Plains, New Jersey 07950 Attn: Vice President, General Counsel Sequana: Axys Pharmaceuticals, Inc. 180 Kimball Way South San Francisco, Ca 94086 Attn: Chief Executive Officer with a copy to: Legal Department 14.5 FORCE MAJEURE. Neither Party shall be liable to the other for failure or delay in the performance of any of its obligations under this Agreement for the time and to the extent such failure or delay is caused by earthquake, riot, civil commotion, war, hostilities between nations, governmental law, order or regulation, embargo, action by the government or any agency thereof, act of God, storm, fire, accident, labor dispute or strike, sabotage, explosion or [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 20. 22 other similar or different contingencies, in each case, beyond the reasonable control of the respective Party. The Party affected by force majeure shall provide the other Party with full particulars thereof as soon as it becomes aware of the same (including its best estimate of the likely extent and duration of the interference with its activities), and will use its best endeavors to overcome the difficulties created thereby and to resume performance of its obligations as soon as practicable. If the performance of any obligation under this Agreement is delayed owing to a force majeure for any continuous period of more than six (6) months, the Parties hereto shall consult with respect to an equitable solution, including the possible termination of this Agreement. 14.6 INDEPENDENT CONTRACTORS. It is understood that both Parties hereto are independent contractors and are engaged in the operation of their own respective businesses, and neither Party hereto is to be considered the agent or partner of the other Party for any purpose whatsoever. Neither Party has any authority to enter into any contracts or assume any obligations for the other Party or make any warranties or representations on behalf of the other Party. Sequana acknowledges that neither it nor any of its employees are employees of Warner or members of any of its benefit plans and that neither it nor any of its employees are eligible to participate in any such benefit plans even if it is later determined that its or any of its employees' status during the period of this Agreement was that of an employee of Warner. In addition, Sequana waives any claim that it may have under the terms of any such benefit plans or under any law for participation in or benefits under any of Warner's benefit plans. 14.7 ADVICE OF COUNSEL. Sequana and Warner have each consulted counsel of their choice regarding this Agreement, and each acknowledges and agrees that this Agreement shall not be deemed to have been drafted by one Party or another and will be construed accordingly. 14.8 SEVERABILITY. In the event that any provisions of this Agreement are determined to be invalid or unenforceable by a court of competent jurisdiction, the remainder of the Agreement shall remain in full force and effect without said provision. The Parties shall in good faith negotiate a substitute clause for any provision declared invalid or unenforceable, which shall most nearly approximate the intent of the Parties in entering this Agreement. 14.9 COMPLIANCE WITH LAWS. Each Party shall furnish to the other Party any information requested or required by that Party during the term of this Agreement to enable that Party to comply with the requirements of any U.S. or foreign federal, state and/or government agency. Each Party shall comply with all applicable U.S., foreign, state, regional and local laws, rules and regulations relating to its activities to be performed pursuant to this Agreement, including without limitation, the United States Foreign Corrupt Practices Act, United States export regulations and such other United States and foreign laws and regulations as may be applicable, and shall obtain all necessary approvals, consents and permits required by the applicable agencies of the government of the United States and foreign jurisdictions. 14.10 NO IMPLIED LICENSES OR WARRANTIES. No right or license under any patent application, issued patent, know-how or other proprietary information is granted or shall be granted by implication. All such rights or licenses are or shall be granted only as expressly provided in the terms of this Agreement. [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 21. 23 14.11 ENTIRE AGREEMENT. This Agreement together with the attached Schedules entered by the Parties of even date herewith, constitute the entire agreement, both written or oral, with respect to the subject matter hereof, and supersede all prior or contemporaneous understandings or agreements, whether written or oral, between Warner and Sequana with respect to such subject matter. 14.12 HEADINGS. The captions to the several Sections and Articles hereof are not a part of this Agreement, but are included merely for convenience of reference only and shall not affect its meaning or interpretation. 14.13 COUNTERPARTS. This Agreement may be executed in two or more counterparts, each of which shall be deemed an original and which together shall constitute one instrument. [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 22. 24 IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be duly executed by their authorized representatives as of the Effective Date. WARNER-LAMBERT COMPANY SEQUANA THERAPEUTICS, INC. By: /s/ Peter B. Corr By:/s/ Daniel H. Petree ------------------------------------ ------------------------------ Name: Peter B. Corr Name: Daniel H. Petree ---------------------------------- ---------------------------- Title: President, R&D Corporate V.P. Title: President & CEO --------------------------------- -------------------------- [ * ] [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 25 SCHEDULE 1.10 COLLABORATION ASSETS 1. [ * ] 2. [ * ] 3. [ * ] 4. [ * ] [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 26 SCHEDULE 1.11(a) EQUIPMENT 1. [ * ] 2. [ * ] 3. [ * ] 4. [ * ] 5. [ * ] [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 27 [ * ] [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 28 SCHEDULE 1.26 IBD TECHNOLOGY 1. [ * ] 2. [ * ] [ * ] [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 29 SCHEDULE 1.37 SEQUANA SOFTWARE Software includes: the applications, source code (except as noted) and code libraries used to analyze data from the Research Program, all applicable documentation (as available), training materials (as available), and where possible Y2K compliance / testing information, as specifically described below. For Perl applications and apple scripts there is no object code. "*" designates that the source code is unavailable. [ * ] [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. B-2. 30 SCHEDULE 3.3 FTEs [ * ] [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. B-3. EX-10.121 5 EXECUTIVE EMPLOYMENT AGREEMENT 1 EXHIBIT 10.121 EXECUTIVE EMPLOYMENT AGREEMENT This Executive Employment Agreement ("Agreement") is entered into as of the 14th day of December, 1999 (the "Effective Date"), by and between William J. Newell ("Executive") and Axys Pharmaceuticals, Inc. (the "Company"). WHEREAS, the Company desires to continue to employ Executive to provide personal services to the Company, and wishes to provide Executive with certain compensation and benefits in return for Executive's services; and WHEREAS, Executive wishes to continue to be employed by the Company and provide personal services to the Company in return for certain compensation and benefits; NOW, THEREFORE, in consideration of the mutual promises and covenants contained herein, it is hereby agreed by and between the parties hereto as follows: ARTICLE I DEFINITIONS For purposes of the Agreement, the following terms are defined as follows: 1.1 "BOARD" means the Board of Directors of the Company. 1.2 "CAUSE" means: (a) Executive's intentional action or intentional failure to act that was performed in bad faith and to the material detriment of the business of the Company; (b) Executive's intentional refusal or intentional failure to act in accordance with any lawful and proper direction or order of the Board or the appropriate individual to whom Executive reports; (c) Executive's willful and habitual neglect of Executive's duties of employment; (d) Executive's violation of any noncompetition or noninterference agreement that Executive has entered into with the Company; or (e) Executive's conviction of a felony crime involving moral turpitude; provided, however, that if any of the foregoing events under clauses (a), (b), (c) or (d) above is capable of being cured, the Company shall provide written notice to Executive describing the nature of such event and Executive shall thereafter have ten (10) business days to cure such event. 1. 2 1.3 "CHANGE IN CONTROL" means the occurrence of any of the following events: (a) a dissolution, liquidation or sale of all or substantially all of the assets of the Company; (b) a merger or consolidation in which the Company is not the surviving corporation; (c) a reverse merger in which the Company is the surviving corporation but shares outstanding immediately preceding the merger are converted by virtue of the merger into other property, whether in the form of securities, cash or otherwise; or (d) the acquisition by any person, entity or group within the meaning of Section 13(d) or 14(d) of the Exchange Act, or any comparable successor provisions (excluding any employee benefit plan, or related trust, sponsored or maintained by the Company or any Affiliate of the Company) of the beneficial ownership (within the meaning of Rule 13d-3 promulgated under the Exchange Act, or comparable successor rule) of securities of the Company representing at least fifty percent (50%) of the combined voting power entitled to vote in the election of directors. 1.4 "COMPANY" means Axys Pharmaceuticals, Inc. or, following a Change in Control, the surviving entity resulting from such transaction. 1.5 "COVERED TERMINATION" means (i) an Involuntary Termination Without Cause that occurs at any time, without regard to a Change in Control, or (ii) a voluntary termination for Good Reason that occurs on or after the effective date of a Change in Control. 1.6 "EXCHANGE ACT" means the Securities Exchange Act of 1934, as amended. 1.7 "GOOD REASON" means that any of the following are undertaken without Executive's express written consent: (a) the assignment to Executive of any duties or responsibilities that results in any diminution or adverse change of Executive's position, status, circumstances of employment or scope of responsibilities; (b) a reduction by the Company in Executive's annual base salary as in effect on the effective date of the Change in Control; (c) the taking of any action by the Company that would adversely affect Executive's participation in, or reduce Executive's benefits under, the Company's benefit plans (including equity benefits) as of the effective date of the Change in Control, except to the extent the benefits of all other executives of the Company are similarly reduced; (d) a relocation of Executive's principal office to a location more than forty (40) miles from the location at which Executive was performing Executive's duties as 2. 3 of the effective date of the Change in Control, except for required travel by Executive on the Company's business; (e) any material breach by the Company of any provision of this Agreement; or (f) any failure by the Company to obtain the assumption of this Agreement by any successor or assign of the Company. 1.8 "INVOLUNTARY TERMINATION WITHOUT CAUSE" means Executive's dismissal or discharge other than for Cause. The termination of Executive's employment as a result of Executive's death or disability will not be deemed to be an Involuntary Termination Without Cause. ARTICLE II EMPLOYMENT BY THE COMPANY 2.1 POSITION AND DUTIES. Subject to terms set forth herein, the Company agrees to continue to employ Executive in the position of Senior Vice President, Corporate and Business Development and General Counsel and Executive hereby accepts such continued employment. Executive shall serve in an executive capacity and shall perform such duties as are customarily associated with the position of Senior Vice President, Corporate and Business Development and General Counsel and such other duties as are assigned to Executive by the Company's Chief Executive Officer. Executive will report to the Chief Executive Officer. During the term of Executive's employment with the Company, Executive will devote Executive's best efforts and substantially all of Executive's business time and attention (except for vacation periods as set forth herein and reasonable periods of illness or other incapacities permitted by the Company's general employment policies or as otherwise set forth in this Agreement) to the business of the Company. 2.2 EMPLOYMENT AT WILL. Both the Company and Executive shall have the right to terminate Executive's employment with the Company at any time, with or without Cause, and without prior notice. If Executive's employment with the Company is terminated, Executive will be eligible to receive severance benefits to the extent provided in this Agreement. 2.3 EMPLOYMENT POLICIES. The employment relationship between the parties shall also be governed by the general employment policies and practices of the Company, including those relating to protection of confidential information and assignment of inventions, except that when the terms of this Agreement differ from or are in conflict with the Company's general employment policies or practices, this Agreement shall control. 3. 4 ARTICLE III COMPENSATION 3.1 BASE SALARY. Executive shall receive for services to be rendered hereunder an annual base salary of $243,000.00, payable on the regular payroll dates of the Company, subject to increase in the sole discretion of the Board of Directors. 3.2 BONUS. Executive shall be eligible for a discretionary bonus, in an amount to be determined solely by the Company, in its discretion. 3.3 STANDARD COMPANY BENEFITS. Executive shall be entitled to all rights and benefits for which Executive is eligible under the terms and conditions of the standard Company benefits and compensation practices that may be in effect from time to time and are provided by the Company to its executive employees generally. 3.4 COMPENSATORY STOCK AWARD. At the Board's meeting on the date hereof, the Board granted Executive an option to acquire seventy-five thousand (75,000) shares of the common stock of the Company (the "Option"). The Option has been granted pursuant to the Company's 1997 Equity Incentive Plan. The Option is an incentive stock option for purposes of Section 422 of the Internal Revenue Code of 1986, as amended (the "Code"), to the extent permitted under the Code. The exercise price per share of the Option will be equal to one hundred percent (100%) of the fair market value of the Company's common stock, as determined pursuant to the Company's 1997 Equity Incentive Plan, on the date of grant. Subject to Executive's continued employment by the Company, the Option vests as to one-forty-eighth (1/48) of the shares of common stock subject to the Option each calendar month for forty-eight (48) months, counted from the Option's date of grant. In all other respects, the Option is to be governed by the terms of the Plan, including the option agreement and grant notice thereunder. ARTICLE IV SEVERANCE AND CHANGE IN CONTROL BENEFITS 4.1 SEVERANCE BENEFITS. If Executive's employment terminates due to a Covered Termination after the date of execution of this Agreement, Executive shall receive any annual base salary and bonus compensation that has accrued but is unpaid as of the date of such Covered Termination. Within thirty (30) days following the date on which the Release described in Section 4.4 below becomes effective in accordance with its terms, Executive shall also receive a lump sum payment equal to one hundred percent (100%) of Executive's annual base salary as in effect during the last regularly scheduled payroll period immediately preceding the Covered Termination, all of the foregoing subject to applicable tax withholding. In addition, following a Covered Termination, Executive and Executive's covered dependents shall be eligible to continue their health care benefit coverage as permitted by COBRA (Internal Revenue Code Section 4980B) at the same cost to Executive as in effect immediately prior to the Covered Termination for the one (l)-year period following the Covered Termination. Executive shall be entitled to maintain 4. 5 coverage for Executive and Executive's eligible dependents at Executive's own expense for the balance of the period that Executive is entitled to coverage under COBRA. 4.2 ACCELERATION OF VESTING OF OUTSTANDING OPTIONS. (a) If Executive's employment with the Company terminates due to a Covered Termination within thirteen (13) months following the effective date of a Change in Control, then the Option to purchase the Company's common stock granted to Executive pursuant to Section 3.3 above shall become immediately fully vested and exercisable as of the date of such Covered Termination. (b) Notwithstanding (a) above, if Executive's employment terminates in connection with a Change in Control that is a transaction that is accounted for as a pooling of interests for financial accounting purposes, then no portion of Executive's Option shall accelerate unless the Company receives reasonable assurances from its independent public accountants (and from the acquiring party's independent public accountants) that in their good faith judgment such acceleration will not affect the pooling of interests accounting treatment of such Change in Control transaction. 4.3 PARACHUTE PAYMENTS. If any payment or benefit Executive would receive in connection with a Change in Control from the Company or otherwise ("Payment") would (i) constitute a "parachute payment" within the meaning of Section 280G of the Internal Revenue Code of 1986, as amended (the "Code"), and (ii) but for this sentence, be subject to the excise tax imposed by Section 4999 of the Code (the "Excise Tax"), then such Payment shall be reduced to the Reduced Amount. The "Reduced Amount" shall be either (x) the largest portion of the Payment that would result in no portion of the Payment being subject to the Excise Tax or (y) the largest portion, up to and including the total, of the Payment, whichever amount, after taking into account all applicable federal, state and local employment taxes, income taxes, and the Excise Tax (all computed at the highest applicable marginal rate), results in Executive's receipt, on an after-tax basis, of the greater amount of the Payment notwithstanding that all or some portion of the Payment may be subject to the Excise Tax. If a reduction in payments or benefits constituting "parachute payments" is necessary so that the Payment equals the Reduced Amount, reduction shall occur in the following order unless Executive elects in writing a different order (provided, however, that such election shall be subject to Company approval if made on or after the effective date of the Change in Control): reduction of cash payments; cancellation of accelerated vesting of stock awards; reduction of employee benefits. In the event that acceleration of vesting of stock award compensation is to be reduced, such acceleration of vesting shall be cancelled in the reverse order of the date of grant of Executive's stock awards unless Executive elects in writing a different order for cancellation. The accounting firm engaged by the Company for general audit purposes as of the day prior to the effective date of the Change in Control shall perform the foregoing calculations. If the accounting firm so engaged by the Company is serving as accountant or auditor for the individual, entity or group effecting the Change in Control, the Company shall appoint a nationally recognized accounting firm to make the determinations required 5. 6 hereunder. The Company shall bear all expenses with respect to the determinations by such accounting firm required to be made hereunder. The accounting firm engaged to make the determinations hereunder shall provide its calculations, together with detailed supporting documentation, to the Company and Executive within fifteen (15) calendar days after the date on which Executive's right to a Payment is triggered (if requested at that time by the Company or Executive) or such other time as requested by the Company or Executive. If the accounting firm determines that no Excise Tax is payable with respect to a Payment, either before or after the application of the Reduced Amount, it shall furnish the Company and Executive with an opinion reasonably acceptable to Executive that no Excise Tax will be imposed with respect to such Payment. Any good faith determinations of the accounting firm made hereunder shall be final, binding and conclusive upon the Company and Executive. 4.4 RELEASE. Upon the occurrence of a Covered Termination, and prior to the receipt of any benefits under Section 4.1 (except pursuant to the first sentence thereof) and Section 4.2 on account of the occurrence of such Covered Termination, Executive shall execute a Release (the "Release") in the form attached hereto as Exhibit A or Exhibit B, as appropriate. Such Release shall specifically relate to all of Executive's rights and claims in existence at the time of such execution and shall confirm Executive's obligations under the Company's standard form of proprietary information agreement. It is understood that Executive has a certain period to consider whether to execute such Release, and Executive may revoke such Release within seven (7) business days after execution. In the event Executive does not execute such Release within the applicable period, or if Executive revokes such Release within the subsequent seven (7) business day period, none of the aforesaid benefits shall be payable under this Agreement and this Agreement shall be null and void. 4.5 MITIGATION. Executive shall not be required to mitigate damages or the amount of any payment provided under this Agreement by seeking other employment or otherwise, nor shall the amount of any payment provided for under this Agreement be reduced by any compensation earned by Executive as a result of employment by another employer or by any retirement benefits received by Executive after the date of the Covered Termination, or otherwise. ARTICLE V PROPRIETARY INFORMATION OBLIGATIONS 5.1 AGREEMENT. Executive agrees to execute and abide by the Proprietary Information and Inventions Agreement attached hereto as Exhibit C. 5.2 REMEDIES. Executive's duties under the Proprietary Information and Inventions Agreement shall survive termination of Executive's employment with the Company and the termination of this Agreement. Executive acknowledges that a remedy at law for any breach or threatened breach by Executive of the provisions of the Proprietary Information and Inventions Agreement would be inadequate, and Executive therefore agrees that the 6. 7 Company shall be entitled to injunctive relief in case of any such breach or threatened breach. ARTICLE VI OUTSIDE ACTIVITIES 6.1 Except with the prior written consent of the Board, Executive shall not during the term of this Agreement undertake or engage in any other employment, occupation or business enterprise, other than ones in which Executive is a passive investor. Executive may engage in civic and not-for-profit activities so long as such activities do not materially interfere with the performance of Executive's duties hereunder. 6.2 During the term of Executive's employment by the Company, except on behalf of the Company, Executive shall not directly or indirectly, whether as an officer, director, stockholder, partner, proprietor, associate, representative, consultant, or in any capacity whatsoever engage in, become financially interested in, be employed by or have any business connection with any other person, corporation, firm, partnership or other entity whatsoever which were known by Executive to compete directly with the Company, throughout the world, in any line of business engaged in (or planned to be engaged in) by the Company; provided, however, that anything above to the contrary notwithstanding, Executive may own, as a passive investor, securities of any competitor corporation, so long as Executive's direct holdings in any one such corporation shall not in the aggregate constitute more than 1% of the voting stock of such corporation. ARTICLE VII NONINTERFERENCE While employed by the Company, and for one (1) year immediately following the date on which Executive terminates employment or otherwise ceases providing services to the Company, Executive agrees not to interfere with the business of the Company by soliciting or attempting to solicit any employee of the Company to terminate such employee's employment in order to become an employee, consultant or independent contractor to or for any competitor of the Company. Executive's duties under this Article 7 shall survive termination of Executive's employment with the Company and the termination of this Agreement. ARTICLE VIII GENERAL PROVISIONS 8.1 NOTICES. Any notices provided hereunder must be in writing and shall be deemed effective upon the earlier of personal delivery (including personal delivery by telex) or the third day after mailing by first class mail, to the Company at its primary office location and to Executive at Executive's address as listed on the Company payroll. 7. 8 8.2 SEVERABILITY. Whenever possible, each provision of this Agreement will be interpreted in such manner as to be effective and valid under applicable law, but if any provision of this Agreement is held to be invalid, illegal or unenforceable in any respect under any applicable law or rule in any jurisdiction, such invalidity, illegality or unenforceability will not affect any other provision or any other jurisdiction, but this Agreement will be reformed, construed and enforced in such jurisdiction as if such invalid, illegal or unenforceable provisions had never been contained herein. 8.3 WAIVER. If either party should waive any breach of any provisions of this Agreement, they shall not thereby be deemed to have waived any preceding or succeeding breach of the same or any other provision of this Agreement. 8.4 COMPLETE AGREEMENT. This Agreement and its Exhibit A, Exhibit B and Exhibit C constitute the entire agreement between Executive and the Company and are the complete, final, and exclusive embodiment of their agreement with regard to this subject matter; provided, however, that this Agreement shall not supersede the letter agreement entered into between Executive and the Company on June 11, 1998, and in the event of any inconsistency between the terms of this Agreement and those of said side letter agreement, the terms of the latter shall control. They are entered into without reliance on any promise or representation other than those expressly contained herein or therein, and they cannot be modified or amended except in a writing signed by an officer of the Company. 8.5 COUNTERPARTS. This Agreement may be executed in separate counterparts, any one of which need not contain signatures of more than one party, but all of which taken together will constitute one and the same Agreement. 8.6 HEADINGS. The headings of the sections hereof are inserted for convenience only and shall not be deemed to constitute a part hereof nor to affect the meaning thereof. 8.7 SUCCESSORS AND ASSIGNS. This Agreement is intended to bind and inure to the benefit of and be enforceable by Executive and the Company, and their respective successors, assigns, heirs, executors and administrators, except that Executive may not assign any of Executive's duties hereunder and Executive may not assign any of Executive's rights hereunder, without the written consent of the Company, which shall not be withheld unreasonably. 8.8 ARBITRATION. Unless otherwise prohibited by law or specified below, all disputes, claims and causes of action, in law or equity, arising from or relating to this Agreement or its enforcement, performance, breach, or interpretation shall be resolved solely and exclusively by final and binding arbitration held in San Francisco County, California through Judicial Arbitration & Mediation Services/Endispute ("JAMS") under the then existing JAMS arbitration rules. However, nothing in this section is intended to prevent either party from obtaining injunctive relief in court to prevent irreparable harm pending the conclusion of any such arbitration. Each party in any such arbitration shall be responsible for its own attorneys' fees, costs and necessary disbursement; provided, however, that if one party refuses to arbitrate and the other party seeks to compel arbitration by court order, if such other party prevails, it shall be entitled to recover 8. 9 reasonable attorneys' fees, costs and necessary disbursements. Pursuant to California Civil Code Section 1717, each party warrants that it was represented by counsel in the negotiation and execution of this Agreement, including the attorneys' fees provision herein. 8.9 ATTORNEYS' FEES. If either party hereto brings any action to enforce rights hereunder, each party in any such action shall be responsible for its own attorneys' fees and costs incurred in connection with such action. 8.10 CHOICE OF LAW. All questions concerning the construction, validity and interpretation of this Agreement will be governed by the law of the State of California. IN WITNESS WHEREOF, the parties have executed this Agreement on the day and year first above written. AXYS PHARMACEUTICALS, INC. By: /s/ John P. Walker -------------------------------- Date: 12/14/99 ------------------------------ Accepted and agreed this 14th day of December, 1999 /s/ William J. Newell - ---------------------------- WILLIAM J. NEWELL Exhibit A: Release (Individual Termination) Exhibit B: Release (Group Termination) Exhibit C: Proprietary Information and Inventions Agreement 9. 10 EXHIBIT A RELEASE (INDIVIDUAL TERMINATION) Certain capitalized terms used in this Release are defined in the Executive Employment Agreement (the "Agreement") which I have executed and of which this Release is a part. I hereby confirm my obligations under the Company's proprietary information and inventions agreement. I acknowledge that I have read and understand Section 1542 of the California Civil Code which reads as follows: "A GENERAL RELEASE DOES NOT EXTEND TO CLAIMS WHICH THE CREDITOR DOES NOT KNOW OR SUSPECT TO EXIST IN HIS FAVOR AT THE TIME OF EXECUTING THE RELEASE, WHICH IF KNOWN BY HIM MUST HAVE MATERIALLY AFFECTED HIS SETTLEMENT WITH THE DEBTOR." I hereby expressly waive and relinquish all rights and benefits under that section and any law of any jurisdiction of similar effect with respect to my release of any claims I may have against the Company. Except as otherwise set forth in this Release, in consideration of benefits I will receive under the Agreement, I hereby release, acquit and forever discharge the Company, its parents and subsidiaries, and their officers, directors, agents, servants, employees, shareholders, successors, assigns and affiliates, of and from any and all claims, liabilities, demands, causes of action, costs, expenses, attorneys' fees, damages, indemnities and obligations of every kind and nature, in law, equity, or otherwise, known and unknown, suspected and unsuspected, disclosed and undisclosed (other than any claim for indemnification I may have as a result of any third party action against me based on my employment with the Company), arising out of or in any way related to agreements, events, acts or conduct at any time prior to and including the date I execute this Release, including, but not limited to: all such claims and demands directly or indirectly arising out of or in any way connected with my employment with the Company or the termination of that employment, including but not limited to, claims of intentional and negligent infliction of emotional distress, any and all tort claims for personal injury, claims or demands related to salary, bonuses, commissions, stock, stock options, or any other ownership interests in the Company, vacation pay, fringe benefits, expense reimbursements, severance pay, or any other form of compensation; claims pursuant to any federal, state or local law or cause of action including, but not limited to, the federal Civil Rights Act of 1964, as amended; the federal Age Discrimination in Employment Act of 1967, as amended ("ADEA"); the federal Employee Retirement Income Security Act of 1974, as amended; the federal Americans with Disabilities Act of 1990; the California Fair Employment and Housing Act, as amended; tort law; contract law; statutory law; common law; wrongful discharge; discrimination; fraud; defamation; emotional distress; and breach of the implied covenant of good faith and fair dealing; provided, however, that nothing in this paragraph shall be construed in any way to release the Company from its obligation to indemnify me pursuant to the Company's indemnification obligation pursuant to agreement or applicable law. I acknowledge that I am knowingly and voluntarily waiving and releasing any rights I may have under ADEA. I also acknowledge that the consideration given under the Agreement 1. 11 for the waiver and release in the preceding paragraph hereof is in addition to anything of value to which I was already entitled. I further acknowledge that I have been advised by this writing, as required by the ADEA, that: (A) my waiver and release do not apply to any rights or claims that may arise on or after the date I execute this Release; (B) I have the right to consult with an attorney prior to executing this Release; (C) I have twenty-one (21) days to consider this Release (although I may choose to voluntarily execute this Release earlier); (D) I have seven (7) days following the execution of this Release by the parties to revoke the Release; and (E) this Release shall not be effective until the date upon which the revocation period has expired, which shall be the eighth (8th) day after this Release is executed by me. WILLIAM J. NEWELL ------------------------------------- Date: -------------------------------- 2. 12 EXHIBIT B RELEASE (GROUP TERMINATION) Certain capitalized terms used in this Release are defined in the Executive Employment Agreement (the "Agreement") which I have executed and of which this Release is a part. I hereby confirm my obligations under the Company's proprietary information and inventions agreement. I acknowledge that I have read and understand Section 1542 of the California Civil Code which reads as follows: "A GENERAL RELEASE DOES NOT EXTEND TO CLAIMS WHICH THE CREDITOR DOES NOT KNOW OR SUSPECT TO EXIST IN HIS FAVOR AT THE TIME OF EXECUTING THE RELEASE, WHICH IF KNOWN BY HIM MUST HAVE MATERIALLY AFFECTED HIS SETTLEMENT WITH THE DEBTOR." I hereby expressly waive and relinquish all rights and benefits under that section and any law of any jurisdiction of similar effect with respect to my release of any claims I may have against the Company. Except as otherwise set forth in this Release, in consideration of benefits I will receive under the Agreement, I hereby release, acquit and forever discharge the Company, its parents and subsidiaries, and their officers, directors, agents, servants, employees, shareholders, successors, assigns and affiliates, of and from any and all claims, liabilities, demands, causes of action, costs, expenses, attorneys' fees, damages, indemnities and obligations of every kind and nature, in law, equity, or otherwise, known and unknown, suspected and unsuspected, disclosed and undisclosed (other than any claim for indemnification I may have as a result of any third party action against me based on my employment with the Company), arising out of or in any way related to agreements, events, acts or conduct at any time prior to and including the date I execute this Release, including, but not limited to: all such claims and demands directly or indirectly arising out of or in any way connected with my employment with the Company or the termination of that employment, including but not limited to, claims of intentional and negligent infliction of emotional distress, any and all tort claims for personal injury, claims or demands related to salary, bonuses, commissions, stock, stock options, or any other ownership interests in the Company, vacation pay, fringe benefits, expense reimbursements, severance pay, or any other form of compensation; claims pursuant to any federal, state or local law or cause of action including, but not limited to, the federal Civil Rights Act of 1964, as amended; the federal Age Discrimination in Employment Act of 1967, as amended ("ADEA"); the federal Employee Retirement Income Security Act of 1974, as amended; the federal Americans with Disabilities Act of 1990; the California Fair Employment and Housing Act, as amended; tort law; contract law; statutory law; common law; wrongful discharge; discrimination; fraud; defamation; emotional distress; and breach of the implied covenant of good faith and fair dealing; provided, however, that nothing in this paragraph shall be construed in any way to release the Company from its obligation to indemnify me pursuant to the Company's indemnification obligation pursuant to agreement or applicable law. I acknowledge that I am knowingly and voluntarily waiving and releasing any rights I may have under ADEA. I also acknowledge that the consideration given under the Agreement 1. 13 for the waiver and release in the preceding paragraph hereof is in addition to anything of value to which I was already entitled. I further acknowledge that I have been advised by this writing, as required by the ADEA, that: (A) my waiver and release do not apply to any rights or claims that may arise on or after the date I execute this Release; (B) I have the right to consult with an attorney prior to executing this Release; (C) I have forty-five (45) days to consider this Release (although I may choose to voluntarily execute this Release earlier); (D) I have seven (7) days following the execution of this Release by the parties to revoke the Release; (E) this Release shall not be effective until the date upon which the revocation period has expired, which shall be the eighth day (8th) after this Release is executed by me; and (F) I have received with this Release a detailed list of the job titles and ages of all employees who were terminated in this group termination and the ages of all employees of the Company in the same job classification or organizational unit who were not terminated. WILLIAM J. NEWELL ------------------------------------- Date: -------------------------------- 2. 14 EXHIBIT C PROPRIETARY INFORMATION AND INVENTIONS AGREEMENT 15 ARRIS PHARMACEUTICAL CORPORATION EMPLOYMENT, CONFIDENTIAL INFORMATION AND INVENTION ASSIGNMENT AGREEMENT As a condition of my employment with ARRIS Pharmaceutical Corporation ("ARRIS"), and in consideration of my employment with ARRIS and my receipt of the compensation now and hereafter paid to me by ARRIS, I agree to the following: 1. AT-WILL EMPLOYMENT. I understand and acknowledge that my employment with ARRIS is for an unspecified duration and constitutes "at-will" employment. I acknowledge that this employment relationship may be terminated at any time, with or without cause, at the option of either ARRIS or myself, with or without notice. 2. CONFIDENTIAL INFORMATION. (a) ARRIS AND THIRD PARTY INFORMATION. I agree at all times during the term of my employment and thereafter, to hold in strictest confidence, and not to use, except for the benefit of ARRIS, or to disclose to any person, firm or corporation without written authorization of an officer of ARRIS, any Confidential Information of ARRIS. I understand that "Confidential Information" means any ARRIS proprietary information, technical data, trade secrets or know-how, including, but not limited to, research and product plans, products, services, customer lists and customers (including, but not limited to, customers of ARRIS on whom I called or with whom I became acquainted during the term of my employment), markets, developments, inventions, processes, formulas, technology, marketing, finances or other business information disclosed to me by ARRIS either directly or indirectly in writing, orally or otherwise. I recognize that ARRIS has received and in the future will receive from third parties their confidential or proprietary information subject to a duty on ARRIS's part to maintain the confidentiality of such information and to use it only for certain limited purposes, and I understand that such information is also Confidential Information. I further understand that Confidential Information does not include any of the foregoing items that has become publicly known and made generally available through no wrongful act of mine or of others who were under confidentiality obligations as to the item or items involved. (b) FORMER EMPLOYER INFORMATION. I agree that I will not, during my employment with ARRIS, improperly use or disclose any proprietary information or trade secrets of any former or concurrent employer or other person or entity and that I will not bring onto the premises of ARRIS any unpublished document or proprietary information belonging to any such employer, person or entity unless consented to in writing by such employer, person or entity. 1. 16 3. INVENTIONS. (a) INVENTIONS RETAINED AND LICENSED. I have attached hereto, as Exhibit A, a list describing all inventions, original works of authorship, developments, improvements, and trade secrets that were made by me prior to my employment with ARRIS (collectively referred to as "Prior Inventions"), that belong to me, that relate to ARRIS's proposed business, products or research and development, and that are not assigned to ARRIS hereunder; or, if no such list is attached, I represent that there are no such Prior Inventions. If in the course of my employment with ARRIS, I incorporate into a ARRIS product, process or machine a Prior Invention owned by me or in which I have an interest, ARRIS is hereby granted and will have a non-exclusive, royalty-free, irrevocable, perpetual, worldwide license, with the right to grant sublicenses, to make, have made, modify, use, and sell such Prior Invention as part of or in connection with such product, process or machine. (b) ASSIGNMENT OF INVENTIONS. I agree that I will promptly make full written disclosure to ARRIS, and will hold in trust for the sole right and benefit of ARRIS, and hereby assign to ARRIS, or its designee, all my right, title, and interest in and to any and all inventions, original works of authorship, developments, concepts, improvements or trade secrets, whether or not patentable or registrable under patent, copyright or similar laws, that I may solely or jointly conceive or develop or reduce to practice, or cause to be conceived or developed or reduced to practice, during the period of time I am in the employ of ARRIS (collectively referred to as "Inventions"), except as provided in Section 3(e) below. I further acknowledge that all original works of authorship that are made by me (solely or jointly with others) within the scope of and during the period of my employment with ARRIS and that are protectable by copyright are works made for hire," as that term is defined in the United States Copyright Act. (c) MAINTENANCE OF RECORDS. I agree to keep and maintain adequate and current written records of all inventions made by me (solely or jointly with others) during the term of my employment with ARRIS. The records will be in the form of notes, sketches, drawings, and any other format that may be specified by ARRIS. The records will be available to and remain the sole property of ARRIS at all times. (d) PATENT AND COPYRIGHT REGISTRATIONS. I agree to assist ARRIS's, or its designee, at ARRIS's expense, in every way to secure ARRIS' rights in the Inventions and any copyrights, patents, mask work rights or other intellectual property rights relating thereto in any and all countries, including disclosing to ARRIS all pertinent information and data with respect thereto, and executing all applications, specifications, oaths, assignments and all other instruments that ARRIS shall deem necessary in order to apply for and obtain such rights and in order to assign and convey to ARRIS, its successors, assigns and nominees the sole and exclusive rights, title and interest in and to such Inventions, and any copyrights, patents, mask work rights or other intellectual property rights relating thereto. I further agree that my obligation to execute or cause to be executed, when it is in my power to do so, any such instrument or papers will continue after the termination of this Agreement. If ARRIS is unable because of my 2 17 mental of physical incapacity or for any other reason to secure my signature to apply for or to pursue any application for any United States or foreign patents or copyright registrations covering Inventions or original works of authorship assigned to ARRIS as above, then I hereby irrevocably designate and appoint ARRIS and its duly authorized officers and agents as my agent and attorney in fact, to act for and in my behalf and stead to execute and file any such applications and to do all other lawfully permitted acts to further the prosecution and issuance of letters patent or copyright registrations thereon with the same legal force and effect as if executed by me. (e) EXCEPTION TO ASSIGNMENTS. I understand that the provisions of this Agreement requiring assignment of Inventions to ARRIS do not apply to any invention that qualifies fully under the provisions of California Labor Code Section 2870 (attached hereto as Exhibit B). I will advise ARRIS promptly in writing of any inventions that I believe meet the criteria in California Labor Code Section 2870 and that are not otherwise disclosed in Exhibit A. 4. CONFLICTING EMPLOYMENT. I agree that, during the term of my employment with ARRIS, I will not engage in any other employment, occupation, consulting or other business activity directly related to the business in which ARRIS is now involved or becomes involved during the term of my employment, nor will I engage in any other activities that conflict with my obligations to ARRIS. 5. RETURNING ARRIS DOCUMENTS. I agree that, at the time of leaving the employ of ARRIS, I will deliver to ARRIS (and will not keep in my possession, recreate or deliver to anyone else) any and all documents or property, or reproductions of any such documents or property, developed by me pursuant to my employment with ARRIS or otherwise belonging to ARRIS, its successors or assigns. 6. SOLICITATION OF EMPLOYEES. I agree that for a period of twelve (12) months immediately following the termination of my relationship with ARRIS for any reason, whether with or without cause, I will not either directly or indirectly solicit, induce, recruit or encourage any of ARRIS's employees to leave their employment, or take away such employees, or attempt to solicit, induce, recruit, encourage or take away employees of the ARRIS, either for myself or for any other person or entity. 7. REPRESENTATIONS. I agree to execute any proper oath or verify any proper document requested by ARRIS to carry out the terms of this Agreement. I represent that my performance of all the terms of this Agreement will not breach any agreement to keep in confidence proprietary information acquired by me in confidence or in trust prior to my employment by ARRIS. I have not entered into, and I agree I will not enter into, any oral or written agreement in conflict with the terms of this Agreement. 3 18 8. ARBITRATION AND EQUITABLE RELIEF. (a) ARBITRATION. Except as provided in Section 8(b) below, I agree that any dispute or controversy arising out of or relating to any interpretation, construction, performance or breach of this Agreement, will be settled by arbitration to be held in San Mateo County, California, in accordance with the rules then in effect of the American Arbitration Association. The arbitrator may grant injunctions or other relief in such dispute or controversy. The decision of the arbitrator will be final, conclusive and binding on the parties to the arbitration. Judgment may be entered on the arbitrator's decision in any court having jurisdiction. ARRIS and I will each pay one-half of the costs and expenses of such arbitration, and each of us will separately pay our counsel fees and expenses. (b) EQUITABLE REMEDIES. I agree that it would be impossible or inadequate to measure and calculate ARRIS's damages for any breach of the covenants set forth in Sections 2,3, and 5 herein. Accordingly, I agree that if I breach my obligations under any of such Sections, ARRIS will have, in addition to any other right or remedy available, the right to obtain injunction from a court of competent jurisdiction restraining such breach or threatened breach and to specific performance of any such provision of this Agreement. I further agree that no bond or other security will be required in obtaining such equitable relief and I hereby consent to the issuance of such injunction and to the ordering of specific performance. I hereby further consent to the personal jurisdiction of the state and federal courts located in California for any lawsuit filed there against me by ARRIS arising from or relating to this Agreement. 9. GENERAL PROVISIONS (a) GOVERNING LAW. This agreement will be governed by the laws of the State of California without reference to conflicts of laws principles. (b) ENTIRE AGREEMENT. This Agreement sets forth the entire agreement and understanding between ARRIS and me relating to the subject matter hereof and merges all prior discussions between us. No modification of or amendment to this Agreement, or any waiver of any rights under this Agreement, will be effective unless in writing signed by the party to be charged. Any subsequent change or changes in my duties, salary or compensation will not affect the validity or scope of this Agreement. 4 19 (c) SEVERABILITY. If one or more of the provisions in this Agreement are deemed void by law, then the remaining provisions will continue in full force and effect. (d) SUCCESSORS AND ASSIGNS. This Agreement will be binding upon my heirs, executors, administrators and other legal representatives and will be for the benefit of ARRIS, its successors, and its assigns. Date: 7/20/98 Signature: /s/ William J. Newell ---------------------------- ------------------------- William J. Newell ----------------------------------- Name of Employee (typed or printed) ARRIS Pharmaceuticals, Inc. Name: /s/ Linda Ballenger ----------------------------------- Print Name: Linda Ballenger ----------------------------- Title: Comp. & Benefits Manager ---------------------------------- 5 20 EXHIBIT A LIST OF PRIOR INVENTIONS AND ORIGINAL WORKS OF AUTHORSHIP IDENTIFYING # OR Title __________________________________ Date _______________ Brief Description X No inventions or improvements - --- _____ Additional sheets attached Signature of Employee /s/ William J. Newell ----------------------- Print Name of Employee William J. Newell Date 7/20/98 Signature of Supervisor /s/ John P. Walker --------------------- Print Name of Supervisor John P. Walker Date 7/20/98 6 21 EXHIBIT B CALIFORNIA LABOR CODE SECTION 2870 EMPLOYMENT AGREEMENTS; ASSIGNMENT OF RIGHTS " (a) ANY PROVISION IN AN EMPLOYMENT AGREEMENT WHICH PROVIDES THAT AN EMPLOYEE SHALL ASSIGN, OR OFFER TO ASSIGN, ANY OF HIS OR HER RIGHTS IN AN INVENTION TO HIS OR HER EMPLOYER SHALL NOT APPLY TO AN INVENTION THAT THE EMPLOYEE DEVELOPED ENTIRELY ON HIS OR HER OWN TIME WITHOUT USING THE EMPLOYER'S EQUIPMENT, SUPPLIES, FACILITIES, OR TRADE SECRET INFORMATION EXCEPT FOR THOSE INVENTIONS THAT EITHER: (1) RELATE AT THE TIME OF CONCEPTION OR REDUCTION TO PRACTICE OF THE INVENTION TO THE EMPLOYER'S BUSINESS, OR ACTUAL OR DEMONSTRABLY ANTICIPATED RESEARCH OR DEVELOPMENT OF THE EMPLOYER. (2) RESULT FROM ANY WORK PERFORMED BY THE EMPLOYEE FOR THE EMPLOYER. (3) TO THE EXTENT A PROVISION IN AN EMPLOYEE AGREEMENT PURPORTS TO REQUIRE AN EMPLOYEE TO ASSIGN AN INVENTION OTHERWISE EXCLUDED FROM BEING REQUIRED TO BE ASSIGNED UNDER SUBDIVISION (a), THE PROVISION IS AGAINST THE PUBLIC POLICY OF THIS STATE AND IS UNENFORCEABLE." 7 EX-10.122 6 EXECUTIVE EMPLOYMENT AGREEMENT 1 EXHIBIT 10.122 EXECUTIVE EMPLOYMENT AGREEMENT This Executive Employment Agreement ("Agreement") is entered into as of the 14th day of December, 1999 (the "Effective Date"), by and between Michael C. Venuti, Ph.D. ("Executive") and Axys Pharmaceuticals, Inc. (the "Company"). WHEREAS, the Company desires to continue to employ Executive to provide personal services to the Company, and wishes to provide Executive with certain compensation and benefits in return for Executive's services; and WHEREAS, Executive wishes to continue to be employed by the Company and provide personal services to the Company in return for certain compensation and benefits; NOW, THEREFORE, in consideration of the mutual promises and covenants contained herein, it is hereby agreed by and between the parties hereto as follows: ARTICLE I DEFINITIONS For purposes of the Agreement, the following terms are defined as follows: 1.1 "BOARD" means the Board of Directors of the Company. 1.2 "CAUSE" means: (a) Executive's intentional action or intentional failure to act that was performed in bad faith and to the material detriment of the business of the Company; (b) Executive's intentional refusal or intentional failure to act in accordance with any lawful and proper direction or order of the Board or the appropriate individual to whom Executive reports; (c) Executive's willful and habitual neglect of Executive's duties of employment; (d) Executive's violation of any noncompetition or noninterference agreement that Executive has entered into with the Company; or (e) Executive's conviction of a felony crime involving moral turpitude; provided, however, that if any of the foregoing events under clauses (a), (b), (c) or (d) above is capable of being cured, the Company shall provide written notice to Executive describing the nature of such event and Executive shall thereafter have ten (10) business days to cure such event. 1. 2 1.3 "CHANGE IN CONTROL" means the occurrence of any of the following events: (a) a dissolution, liquidation or sale of all or substantially all of the assets of the Company; (b) a merger or consolidation in which the Company is not the surviving corporation; (c) a reverse merger in which the Company is the surviving corporation but shares outstanding immediately preceding the merger are converted by virtue of the merger into other property, whether in the form of securities, cash or otherwise; or (d) the acquisition by any person, entity or group within the meaning of Section 13(d) or 14(d) of the Exchange Act, or any comparable successor provisions (excluding any employee benefit plan, or related trust, sponsored or maintained by the Company or any Affiliate of the Company) of the beneficial ownership (within the meaning of Rule 13d-3 promulgated under the Exchange Act, or comparable successor rule) of securities of the Company representing at least fifty percent (50%) of the combined voting power entitled to vote in the election of directors. 1.4 "COMPANY" means Axys Pharmaceuticals, Inc. or, following a Change in Control, the surviving entity resulting from such transaction. 1.5 "COVERED TERMINATION" means (i) an Involuntary Termination Without Cause that occurs at any time, without regard to a Change in Control, or (ii) a voluntary termination for Good Reason that occurs on or after the effective date of a Change in Control. 1.6 "EXCHANGE ACT" means the Securities Exchange Act of 1934, as amended. 1.7 "GOOD REASON" means that any of the following are undertaken without Executive's express written consent: (a) the assignment to Executive of any duties or responsibilities that results in any diminution or adverse change of Executive's position, status, circumstances of employment or scope of responsibilities; (b) a reduction by the Company in Executive's annual base salary as in effect on the effective date of the Change in Control; (c) the taking of any action by the Company that would adversely affect Executive's participation in, or reduce Executive's benefits under, the Company's benefit plans (including equity benefits) as of the effective date of the Change in Control, except to the extent the benefits of all other executives of the Company are similarly reduced; (d) a relocation of Executive's principal office to a location more than forty (40) miles from the location at which Executive was performing Executive's duties as 2. 3 of the effective date of the Change in Control, except for required travel by Executive on the Company's business; (e) any material breach by the Company of any provision of this Agreement; or (f) any failure by the Company to obtain the assumption of this Agreement by any successor or assign of the Company. 1.8 "INVOLUNTARY TERMINATION WITHOUT CAUSE" means Executive's dismissal or discharge other than for Cause. The termination of Executive's employment as a result of Executive's death or disability will not be deemed to be an Involuntary Termination Without Cause. ARTICLE II EMPLOYMENT BY THE COMPANY 2.1 POSITION AND DUTIES. Subject to terms set forth herein, the Company agrees to continue to employ Executive in the position of Senior Vice President, Research and Preclinical Development and Chief Technical Officer and Executive hereby accepts such continued employment. Executive shall serve in an executive capacity and shall perform such duties as are customarily associated with the position of Senior Vice President, Research and Preclinical Development and Chief Technical Officer and such other duties as are assigned to Executive by the Company's Chief Executive Officer. Executive will report to the Chief Executive Officer. During the term of Executive's employment with the Company, Executive will devote Executive's best efforts and substantially all of Executive's business time and attention (except for vacation periods as set forth herein and reasonable periods of illness or other incapacities permitted by the Company's general employment policies or as otherwise set forth in this Agreement) to the business of the Company. 2.2 EMPLOYMENT AT WILL. Both the Company and Executive shall have the right to terminate Executive's employment with the Company at any time, with or without Cause, and without prior notice. If Executive's employment with the Company is terminated, Executive will be eligible to receive severance benefits to the extent provided in this Agreement. 2.3 EMPLOYMENT POLICIES. The employment relationship between the parties shall also be governed by the general employment policies and practices of the Company, including those relating to protection of confidential information and assignment of inventions, except that when the terms of this Agreement differ from or are in conflict with the Company's general employment policies or practices, this Agreement shall control. 3. 4 ARTICLE III COMPENSATION 3.1 BASE SALARY. Executive shall receive for services to be rendered hereunder an annual base salary of $250,000.00, payable on the regular payroll dates of the Company, subject to increase in the sole discretion of the Board of Directors. 3.2 BONUS. Executive shall be eligible for a discretionary bonus, in an amount to be determined solely by the Company, in its discretion. 3.3 STANDARD COMPANY BENEFITS. Executive shall be entitled to all rights and benefits for which Executive is eligible under the terms and conditions of the standard Company benefits and compensation practices that may be in effect from time to time and are provided by the Company to its executive employees generally. 3.4 COMPENSATORY STOCK AWARD. At the Board's meeting on the date hereof, the Board granted Executive an option to acquire seventy-five thousand (75,000) shares of the common stock of the Company (the "Option"). The Option has been granted pursuant to the Company's 1997 Equity Incentive Plan. The Option is an incentive stock option for purposes of Section 422 of the Internal Revenue Code of 1986, as amended (the "Code"), to the extent permitted under the Code. The exercise price per share of the Option will be equal to one hundred percent (100%) of the fair market value of the Company's common stock, as determined pursuant to the Company's 1997 Equity Incentive Plan, on the date of grant. Subject to Executive's continued employment by the Company, the Option vests as to one-forty-eighth (1/48) of the shares of common stock subject to the Option each calendar month for forty-eight (48) months, counted from the Option's date of grant. In all other respects, the Option is to be governed by the terms of the Plan, including the option agreement and grant notice thereunder. ARTICLE IV SEVERANCE AND CHANGE IN CONTROL BENEFITS 4.1 SEVERANCE BENEFITS. If Executive's employment terminates due to a Covered Termination after the date of execution of this Agreement, Executive shall receive any annual base salary and bonus compensation that has accrued but is unpaid as of the date of such Covered Termination. Within thirty (30) days following the date on which the Release described in Section 4.4 below becomes effective in accordance with its terms, Executive shall also receive a lump sum payment equal to one hundred percent (100%) of Executive's annual base salary as in effect during the last regularly scheduled payroll period immediately preceding the Covered Termination, all of the foregoing subject to applicable tax withholding. In addition, following a Covered Termination, Executive and Executive's covered dependents shall be eligible to continue their health care benefit coverage as permitted by COBRA (Internal Revenue Code Section 4980B) at the same cost to Executive as in effect immediately prior to the Covered Termination for the one (l)-year period following the Covered Termination. Executive shall be entitled to maintain 4. 5 coverage for Executive and Executive's eligible dependents at Executive's own expense for the balance of the period that Executive is entitled to coverage under COBRA. 4.2 ACCELERATION OF VESTING OF OUTSTANDING OPTIONS. (a) If Executive's employment with the Company terminates due to a Covered Termination within thirteen (13) months following the effective date of a Change in Control, then the Option to purchase the Company's common stock granted to Executive pursuant to Section 3.3 above shall become immediately fully vested and exercisable as of the date of such Covered Termination. (b) Notwithstanding (a) above, if Executive's employment terminates in connection with a Change in Control that is a transaction that is accounted for as a pooling of interests for financial accounting purposes, then no portion of Executive's Option shall accelerate unless the Company receives reasonable assurances from its independent public accountants (and from the acquiring party's independent public accountants) that in their good faith judgment such acceleration will not affect the pooling of interests accounting treatment of such Change in Control transaction. 4.3 PARACHUTE PAYMENTS. If any payment or benefit Executive would receive in connection with a Change in Control from the Company or otherwise ("Payment") would (i) constitute a "parachute payment" within the meaning of Section 280G of the Internal Revenue Code of 1986, as amended (the "Code"), and (ii) but for this sentence, be subject to the excise tax imposed by Section 4999 of the Code (the "Excise Tax"), then such Payment shall be reduced to the Reduced Amount. The "Reduced Amount" shall be either (x) the largest portion of the Payment that would result in no portion of the Payment being subject to the Excise Tax or (y) the largest portion, up to and including the total, of the Payment, whichever amount, after taking into account all applicable federal, state and local employment taxes, income taxes, and the Excise Tax (all computed at the highest applicable marginal rate), results in Executive's receipt, on an after-tax basis, of the greater amount of the Payment notwithstanding that all or some portion of the Payment may be subject to the Excise Tax. If a reduction in payments or benefits constituting "parachute payments" is necessary so that the Payment equals the Reduced Amount, reduction shall occur in the following order unless Executive elects in writing a different order (provided, however, that such election shall be subject to Company approval if made on or after the effective date of the Change in Control): reduction of cash payments; cancellation of accelerated vesting of stock awards; reduction of employee benefits. In the event that acceleration of vesting of stock award compensation is to be reduced, such acceleration of vesting shall be cancelled in the reverse order of the date of grant of Executive's stock awards unless Executive elects in writing a different order for cancellation. The accounting firm engaged by the Company for general audit purposes as of the day prior to the effective date of the Change in Control shall perform the foregoing calculations. If the accounting firm so engaged by the Company is serving as accountant or auditor for the individual, entity or group effecting the Change in Control, the Company shall appoint a nationally recognized accounting firm to make the determinations required 5. 6 hereunder. The Company shall bear all expenses with respect to the determinations by such accounting firm required to be made hereunder. The accounting firm engaged to make the determinations hereunder shall provide its calculations, together with detailed supporting documentation, to the Company and Executive within fifteen (15) calendar days after the date on which Executive's right to a Payment is triggered (if requested at that time by the Company or Executive) or such other time as requested by the Company or Executive. If the accounting firm determines that no Excise Tax is payable with respect to a Payment, either before or after the application of the Reduced Amount, it shall furnish the Company and Executive with an opinion reasonably acceptable to Executive that no Excise Tax will be imposed with respect to such Payment. Any good faith determinations of the accounting firm made hereunder shall be final, binding and conclusive upon the Company and Executive. 4.4 RELEASE. Upon the occurrence of a Covered Termination, and prior to the receipt of any benefits under Section 4.1 (except pursuant to the first sentence thereof) and Section 4.2 on account of the occurrence of such Covered Termination, Executive shall execute a Release (the "Release") in the form attached hereto as Exhibit A or Exhibit B, as appropriate. Such Release shall specifically relate to all of Executive's rights and claims in existence at the time of such execution and shall confirm Executive's obligations under the Company's standard form of proprietary information agreement. It is understood that Executive has a certain period to consider whether to execute such Release, and Executive may revoke such Release within seven (7) business days after execution. In the event Executive does not execute such Release within the applicable period, or if Executive revokes such Release within the subsequent seven (7) business day period, none of the aforesaid benefits shall be payable under this Agreement and this Agreement shall be null and void. 4.5 MITIGATION. Executive shall not be required to mitigate damages or the amount of any payment provided under this Agreement by seeking other employment or otherwise, nor shall the amount of any payment provided for under this Agreement be reduced by any compensation earned by Executive as a result of employment by another employer or by any retirement benefits received by Executive after the date of the Covered Termination, or otherwise. ARTICLE V PROPRIETARY INFORMATION OBLIGATIONS 5.1 AGREEMENT. Executive agrees to execute and abide by the Proprietary Information and Inventions Agreement attached hereto as Exhibit C. 5.2 REMEDIES. Executive's duties under the Proprietary Information and Inventions Agreement shall survive termination of Executive's employment with the Company and the termination of this Agreement. Executive acknowledges that a remedy at law for any breach or threatened breach by Executive of the provisions of the Proprietary Information and Inventions Agreement would be inadequate, and Executive therefore agrees that the 6. 7 Company shall be entitled to injunctive relief in case of any such breach or threatened breach. ARTICLE VI OUTSIDE ACTIVITIES 6.1 Except with the prior written consent of the Board, Executive shall not during the term of this Agreement undertake or engage in any other employment, occupation or business enterprise, other than ones in which Executive is a passive investor. Executive may engage in civic and not-for-profit activities so long as such activities do not materially interfere with the performance of Executive's duties hereunder. 6.2 During the term of Executive's employment by the Company, except on behalf of the Company, Executive shall not directly or indirectly, whether as an officer, director, stockholder, partner, proprietor, associate, representative, consultant, or in any capacity whatsoever engage in, become financially interested in, be employed by or have any business connection with any other person, corporation, firm, partnership or other entity whatsoever which were known by Executive to compete directly with the Company, throughout the world, in any line of business engaged in (or planned to be engaged in) by the Company; provided, however, that anything above to the contrary notwithstanding, Executive may own, as a passive investor, securities of any competitor corporation, so long as Executive's direct holdings in any one such corporation shall not in the aggregate constitute more than 1% of the voting stock of such corporation. ARTICLE VII NONINTERFERENCE While employed by the Company, and for one (1) year immediately following the date on which Executive terminates employment or otherwise ceases providing services to the Company, Executive agrees not to interfere with the business of the Company by soliciting or attempting to solicit any employee of the Company to terminate such employee's employment in order to become an employee, consultant or independent contractor to or for any competitor of the Company. Executive's duties under this Article 7 shall survive termination of Executive's employment with the Company and the termination of this Agreement. ARTICLE VIII GENERAL PROVISIONS 8.1 NOTICES. Any notices provided hereunder must be in writing and shall be deemed effective upon the earlier of personal delivery (including personal delivery by telex) or the third day after mailing by first class mail, to the Company at its primary office location and to Executive at Executive's address as listed on the Company payroll. 7. 8 8.2 SEVERABILITY. Whenever possible, each provision of this Agreement will be interpreted in such manner as to be effective and valid under applicable law, but if any provision of this Agreement is held to be invalid, illegal or unenforceable in any respect under any applicable law or rule in any jurisdiction, such invalidity, illegality or unenforceability will not affect any other provision or any other jurisdiction, but this Agreement will be reformed, construed and enforced in such jurisdiction as if such invalid, illegal or unenforceable provisions had never been contained herein. 8.3 WAIVER. If either party should waive any breach of any provisions of this Agreement, they shall not thereby be deemed to have waived any preceding or succeeding breach of the same or any other provision of this Agreement. 8.4 COMPLETE AGREEMENT. This Agreement and its Exhibit A, Exhibit B and Exhibit C constitute the entire agreement between Executive and the Company and are the complete, final, and exclusive embodiment of their agreement with regard to this subject matter. They are entered into without reliance on any promise or representation other than those expressly contained herein or therein, and they cannot be modified or amended except in a writing signed by an officer of the Company. 8.5 COUNTERPARTS. This Agreement may be executed in separate counterparts, any one of which need not contain signatures of more than one party, but all of which taken together will constitute one and the same Agreement. 8.6 HEADINGS. The headings of the sections hereof are inserted for convenience only and shall not be deemed to constitute a part hereof nor to affect the meaning thereof. 8.7 SUCCESSORS AND ASSIGNS. This Agreement is intended to bind and inure to the benefit of and be enforceable by Executive and the Company, and their respective successors, assigns, heirs, executors and administrators, except that Executive may not assign any of Executive's duties hereunder and Executive may not assign any of Executive's rights hereunder, without the written consent of the Company, which shall not be withheld unreasonably. 8.8 ARBITRATION. Unless otherwise prohibited by law or specified below, all disputes, claims and causes of action, in law or equity, arising from or relating to this Agreement or its enforcement, performance, breach, or interpretation shall be resolved solely and exclusively by final and binding arbitration held in San Francisco County, California through Judicial Arbitration & Mediation Services/Endispute ("JAMS") under the then existing JAMS arbitration rules. However, nothing in this section is intended to prevent either party from obtaining injunctive relief in court to prevent irreparable harm pending the conclusion of any such arbitration. Each party in any such arbitration shall be responsible for its own attorneys' fees, costs and necessary disbursement; provided, however, that if one party refuses to arbitrate and the other party seeks to compel arbitration by court order, if such other party prevails, it shall be entitled to recover reasonable attorneys' fees, costs and necessary disbursements. Pursuant to California Civil Code Section 1717, each party warrants that it was represented by counsel in the 8. 9 negotiation and execution of this Agreement, including the attorneys' fees provision herein. 8.9 ATTORNEYS' FEES. If either party hereto brings any action to enforce rights hereunder, each party in any such action shall be responsible for its own attorneys' fees and costs incurred in connection with such action. 8.10 CHOICE OF LAW. All questions concerning the construction, validity and interpretation of this Agreement will be governed by the law of the State of California. IN WITNESS WHEREOF, the parties have executed this Agreement on the day and year first above written. AXYS PHARMACEUTICALS, INC. By: /s/ John P. Walker --------------------------------- Date: 12/14/99 ------------------------------- Accepted and agreed this 14th day of December, 1999 /s/ Michael C. Venuti - ---------------------------- MICHAEL C. VENUTI, PH.D. Exhibit A: Release (Individual Termination) Exhibit B: Release (Group Termination) Exhibit C: Proprietary Information and Inventions Agreement 9. 10 EXHIBIT A RELEASE (INDIVIDUAL TERMINATION) Certain capitalized terms used in this Release are defined in the Executive Employment Agreement (the "Agreement") which I have executed and of which this Release is a part. I hereby confirm my obligations under the Company's proprietary information and inventions agreement. I acknowledge that I have read and understand Section 1542 of the California Civil Code which reads as follows: "A GENERAL RELEASE DOES NOT EXTEND TO CLAIMS WHICH THE CREDITOR DOES NOT KNOW OR SUSPECT TO EXIST IN HIS FAVOR AT THE TIME OF EXECUTING THE RELEASE, WHICH IF KNOWN BY HIM MUST HAVE MATERIALLY AFFECTED HIS SETTLEMENT WITH THE DEBTOR." I hereby expressly waive and relinquish all rights and benefits under that section and any law of any jurisdiction of similar effect with respect to my release of any claims I may have against the Company. Except as otherwise set forth in this Release, in consideration of benefits I will receive under the Agreement, I hereby release, acquit and forever discharge the Company, its parents and subsidiaries, and their officers, directors, agents, servants, employees, shareholders, successors, assigns and affiliates, of and from any and all claims, liabilities, demands, causes of action, costs, expenses, attorneys' fees, damages, indemnities and obligations of every kind and nature, in law, equity, or otherwise, known and unknown, suspected and unsuspected, disclosed and undisclosed (other than any claim for indemnification I may have as a result of any third party action against me based on my employment with the Company), arising out of or in any way related to agreements, events, acts or conduct at any time prior to and including the date I execute this Release, including, but not limited to: all such claims and demands directly or indirectly arising out of or in any way connected with my employment with the Company or the termination of that employment, including but not limited to, claims of intentional and negligent infliction of emotional distress, any and all tort claims for personal injury, claims or demands related to salary, bonuses, commissions, stock, stock options, or any other ownership interests in the Company, vacation pay, fringe benefits, expense reimbursements, severance pay, or any other form of compensation; claims pursuant to any federal, state or local law or cause of action including, but not limited to, the federal Civil Rights Act of 1964, as amended; the federal Age Discrimination in Employment Act of 1967, as amended ("ADEA"); the federal Employee Retirement Income Security Act of 1974, as amended; the federal Americans with Disabilities Act of 1990; the California Fair Employment and Housing Act, as amended; tort law; contract law; statutory law; common law; wrongful discharge; discrimination; fraud; defamation; emotional distress; and breach of the implied covenant of good faith and fair dealing; provided, however, that nothing in this paragraph shall be construed in any way to release the Company from its obligation to indemnify me pursuant to the Company's indemnification obligation pursuant to agreement or applicable law. I acknowledge that I am knowingly and voluntarily waiving and releasing any rights I may have under ADEA. I also acknowledge that the consideration given under the Agreement 1. 11 for the waiver and release in the preceding paragraph hereof is in addition to anything of value to which I was already entitled. I further acknowledge that I have been advised by this writing, as required by the ADEA, that: (A) my waiver and release do not apply to any rights or claims that may arise on or after the date I execute this Release; (B) I have the right to consult with an attorney prior to executing this Release; (C) I have twenty-one (21) days to consider this Release (although I may choose to voluntarily execute this Release earlier); (D) I have seven (7) days following the execution of this Release by the parties to revoke the Release; and (E) this Release shall not be effective until the date upon which the revocation period has expired, which shall be the eighth (8th) day after this Release is executed by me. MICHAEL C. VENUTI, PH.D. ---------------------------------- Date: ----------------------------- 2. 12 EXHIBIT B RELEASE (GROUP TERMINATION) Certain capitalized terms used in this Release are defined in the Executive Employment Agreement (the "Agreement") which I have executed and of which this Release is a part. I hereby confirm my obligations under the Company's proprietary information and inventions agreement. I acknowledge that I have read and understand Section 1542 of the California Civil Code which reads as follows: "A GENERAL RELEASE DOES NOT EXTEND TO CLAIMS WHICH THE CREDITOR DOES NOT KNOW OR SUSPECT TO EXIST IN HIS FAVOR AT THE TIME OF EXECUTING THE RELEASE, WHICH IF KNOWN BY HIM MUST HAVE MATERIALLY AFFECTED HIS SETTLEMENT WITH THE DEBTOR." I hereby expressly waive and relinquish all rights and benefits under that section and any law of any jurisdiction of similar effect with respect to my release of any claims I may have against the Company. Except as otherwise set forth in this Release, in consideration of benefits I will receive under the Agreement, I hereby release, acquit and forever discharge the Company, its parents and subsidiaries, and their officers, directors, agents, servants, employees, shareholders, successors, assigns and affiliates, of and from any and all claims, liabilities, demands, causes of action, costs, expenses, attorneys' fees, damages, indemnities and obligations of every kind and nature, in law, equity, or otherwise, known and unknown, suspected and unsuspected, disclosed and undisclosed (other than any claim for indemnification I may have as a result of any third party action against me based on my employment with the Company), arising out of or in any way related to agreements, events, acts or conduct at any time prior to and including the date I execute this Release, including, but not limited to: all such claims and demands directly or indirectly arising out of or in any way connected with my employment with the Company or the termination of that employment, including but not limited to, claims of intentional and negligent infliction of emotional distress, any and all tort claims for personal injury, claims or demands related to salary, bonuses, commissions, stock, stock options, or any other ownership interests in the Company, vacation pay, fringe benefits, expense reimbursements, severance pay, or any other form of compensation; claims pursuant to any federal, state or local law or cause of action including, but not limited to, the federal Civil Rights Act of 1964, as amended; the federal Age Discrimination in Employment Act of 1967, as amended ("ADEA"); the federal Employee Retirement Income Security Act of 1974, as amended; the federal Americans with Disabilities Act of 1990; the California Fair Employment and Housing Act, as amended; tort law; contract law; statutory law; common law; wrongful discharge; discrimination; fraud; defamation; emotional distress; and breach of the implied covenant of good faith and fair dealing; provided, however, that nothing in this paragraph shall be construed in any way to release the Company from its obligation to indemnify me pursuant to the Company's indemnification obligation pursuant to agreement or applicable law. I acknowledge that I am knowingly and voluntarily waiving and releasing any rights I may have under ADEA. I also acknowledge that the consideration given under the Agreement 1. 13 for the waiver and release in the preceding paragraph hereof is in addition to anything of value to which I was already entitled. I further acknowledge that I have been advised by this writing, as required by the ADEA, that: (A) my waiver and release do not apply to any rights or claims that may arise on or after the date I execute this Release; (B) I have the right to consult with an attorney prior to executing this Release; (C) I have forty-five (45) days to consider this Release (although I may choose to voluntarily execute this Release earlier); (D) I have seven (7) days following the execution of this Release by the parties to revoke the Release; (E) this Release shall not be effective until the date upon which the revocation period has expired, which shall be the eighth day (8th) after this Release is executed by me; and (F) I have received with this Release a detailed list of the job titles and ages of all employees who were terminated in this group termination and the ages of all employees of the Company in the same job classification or organizational unit who were not terminated. MICHAEL C. VENUTI, PH.D. ---------------------------------- Date: ----------------------------- 2. 14 EXHIBIT C PROPRIETARY INFORMATION AND INVENTIONS AGREEMENT 15 ARRIS PHARMACEUTICAL CORPORATION EMPLOYMENT, CONFIDENTIAL INFORMATION AND INVENTION ASSIGNMENT AGREEMENT As a condition of my employment with ARRIS Pharmaceutical Corporation ("ARRIS"), and in consideration of my employment with ARRIS and my receipt of the compensation now and hereafter paid to me by ARRIS, I agree to the following: 1. AT-WILL EMPLOYMENT. I understand and acknowledge that my employment with ARRIS is for an unspecified duration and constitutes "at-will" employment. I acknowledge that this employment relationship may be terminated at any time, with or without cause, at the option of either ARRIS or myself, with or without notice. 2. CONFIDENTIAL INFORMATION. (a) ARRIS AND THIRD PARTY INFORMATION. I agree at all times during the term of my employment and thereafter, to hold in strictest confidence, and not to use, except for the benefit of ARRIS, or to disclose to any person, firm or corporation without written authorization of an officer of ARRIS, any Confidential Information of ARRIS. I understand that "Confidential Information" means any ARRIS proprietary information, technical data, trade secrets or know-how, including, but not limited to, research and product plans, products, services, customer lists and customers (including, but not limited to, customers of ARRIS on whom I called or with whom I became acquainted during the term of my employment), markets, developments, inventions, processes, formulas, technology, marketing, finances or other business information disclosed to me by ARRIS either directly or indirectly in writing, orally or otherwise. I recognize that ARRIS has received and in the future will receive from third parties their confidential or proprietary information subject to a duty on ARRIS's part to maintain the confidentiality of such information and to use it only for certain limited purposes, and I understand that such information is also Confidential Information. I further understand that Confidential Information does not include any of the foregoing items that has become publicly known and made generally available through no wrongful act of mine or of others who were under confidentiality obligations as to the item or items involved. (b) FORMER EMPLOYER INFORMATION. I agree that I will not, during my employment with ARRIS, improperly use or disclose any proprietary information or trade secrets of any former or concurrent employer or other person or entity and that I will not bring onto the premises of ARRIS any unpublished document or proprietary information belonging to any such employer, person or entity unless consented to in writing by such employer, person or entity. 1 16 3. INVENTIONS. (a) INVENTIONS RETAINED AND LICENSED. I have attached hereto, as Exhibit A, a list describing all inventions, original works of authorship, developments, improvements, and trade secrets that were made by me prior to my employment with ARRIS (collectively referred to as "Prior Inventions"), that belong to me, that relate to ARRIS's proposed business, products or research and development, and that are not assigned to ARRIS hereunder; or, if no such list is attached, I represent that there are no such Prior Inventions. If in the course of my employment with ARRIS, I incorporate into a ARRIS product, process or machine a Prior Invention owned by me or in which I have an interest, ARRIS is hereby granted and will have a non-exclusive, royalty-free, irrevocable, perpetual, worldwide license, with the right to grant sublicenses, to make, have made, modify, use, and sell such Prior Invention as part of or in connection with such product, process or machine. (b) ASSIGNMENT OF INVENTIONS. I agree that I will promptly make full written disclosure to ARRIS, and will hold in trust for the sole right and benefit of ARRIS, and hereby assign to ARRIS, or its designee, all my right, title, and interest in and to any and all inventions, original works of authorship, developments, concepts, improvements or trade secrets, whether or not patentable or registrable under patent, copyright or similar laws, that I may solely or jointly conceive or develop or reduce to practice, or cause to be conceived or developed or reduced to practice, during the period of time I am in the employ of ARRIS (collectively referred to as "Inventions"), except as provided in Section 3(e) below. I further acknowledge that all original works of authorship that are made by me (solely or jointly with others) within the scope of and during the period of my employment with ARRIS and that are protectable by copyright are works made for hire," as that term is defined in the United States Copyright Act. (c) MAINTENANCE OF RECORDS. I agree to keep and maintain adequate and current written records of all inventions made by me (solely or jointly with others) during the term of my employment with ARRIS. The records will be in the form of notes, sketches, drawings, and any other format that may be specified by ARRIS. The records will be available to and remain the sole property of ARRIS at all times. (d) PATENT AND COPYRIGHT REGISTRATIONS. I agree to assist ARRIS's, or its designee, at ARRIS's expense, in every way to secure ARRIS' rights in the Inventions and any copyrights, patents, mask work rights or other intellectual property rights relating thereto in any and all countries, including disclosing to ARRIS all pertinent information and data with respect thereto, and executing all applications, specifications, oaths, assignments and all other instruments that ARRIS shall deem necessary in order to apply for and obtain such rights and in order to assign and convey to ARRIS, its successors, assigns and nominees the sole and exclusive rights, title and interest in and to such Inventions, and any copyrights, patents, mask work rights or other intellectual property rights relating thereto. I further agree that my obligation to execute or cause to be executed, when it is in my power to do so, any such instrument or papers will continue after the termination of this Agreement. If ARRIS is unable because of my 2 17 mental of physical incapacity or for any other reason to secure my signature to apply for or to pursue any application for any United States or foreign patents or copyright registrations covering Inventions or original works of authorship assigned to ARRIS as above, then I hereby irrevocably designate and appoint ARRIS and its duly authorized officers and agents as my agent and attorney in fact, to act for and in my behalf and stead to execute and file any such applications and to do all other lawfully permitted acts to further the prosecution and issuance of letters patent or copyright registrations thereon with the same legal force and effect as if executed by me. (e) EXCEPTION TO ASSIGNMENTS. I understand that the provisions of this Agreement requiring assignment of Inventions to ARRIS do not apply to any invention that qualifies fully under the provisions of California Labor Code Section 2870 (attached hereto as Exhibit B). I will advise ARRIS promptly in writing of any inventions that I believe meet the criteria in California Labor Code Section 2870 and that are not otherwise disclosed in Exhibit A. 4. CONFLICTING EMPLOYMENT. I agree that, during the term of my employment with ARRIS, I will not engage in any other employment, occupation, consulting or other business activity directly related to the business in which ARRIS is now involved or becomes involved during the term of my employment, nor will I engage in any other activities that conflict with my obligations to ARRIS. 5. RETURNING ARRIS DOCUMENTS. I agree that, at the time of leaving the employ of ARRIS, I will deliver to ARRIS (and will not keep in my possession, recreate or deliver to anyone else) any and all documents or property, or reproductions of any such documents or property, developed by me pursuant to my employment with ARRIS or otherwise belonging to ARRIS, its successors or assigns. 6. SOLICITATION OF EMPLOYEES. I agree that for a period of twelve (12) months immediately following the termination of my relationship with ARRIS for any reason, whether with or without cause, I will not either directly or indirectly solicit, induce, recruit or encourage any of ARRIS's employees to leave their employment, or take away such employees, or attempt to solicit, induce, recruit, encourage or take away employees of the ARRIS, either for myself or for any other person or entity. 7. REPRESENTATIONS. I agree to execute any proper oath or verify any proper document requested by ARRIS to carry out the terms of this Agreement. I represent that my performance of all the terms of this Agreement will not breach any agreement to keep in confidence proprietary information acquired by me in confidence or in trust prior to my employment by ARRIS. I have not entered into, and I agree I will not enter into, any oral or written agreement in conflict with the terms of this Agreement. 3 18 8. ARBITRATION AND EQUITABLE RELIEF. (a) ARBITRATION. Except as provided in Section 8(b) below, I agree that any dispute or controversy arising out of or relating to any interpretation, construction, performance or breach of this Agreement, will be settled by arbitration to be held in San Mateo County, California, in accordance with the rules then in effect of the American Arbitration Association. The arbitrator may grant injunctions or other relief in such dispute or controversy. The decision of the arbitrator will be final, conclusive and binding on the parties to the arbitration. Judgment may be entered on the arbitrator's decision in any court having jurisdiction. ARRIS and I will each pay one-half of the costs and expenses of such arbitration, and each of us will separately pay our counsel fees and expenses. (b) EQUITABLE REMEDIES. I agree that it would be impossible or inadequate to measure and calculate ARRIS's damages for any breach of the covenants set forth in Sections 2,3, and 5 herein. Accordingly, I agree that if I breach my obligations under any of such Sections, ARRIS will have, in addition to any other right or remedy available, the right to obtain injunction from a court of competent jurisdiction restraining such breach or threatened breach and to specific performance of any such provision of this Agreement. I further agree that no bond or other security will be required in obtaining such equitable relief and I hereby consent to the issuance of such injunction and to the ordering of specific performance. I hereby further consent to the personal jurisdiction of the state and federal courts located in California for any lawsuit filed there against me by ARRIS arising from or relating to this Agreement. 9. GENERAL PROVISIONS (a) GOVERNING LAW. This agreement will be governed by the laws of the State of California without reference to conflicts of laws principles. (b) ENTIRE AGREEMENT. This Agreement sets forth the entire agreement and understanding between ARRIS and me relating to the subject matter hereof and merges all prior discussions between us. No modification of or amendment to this Agreement, or any waiver of any rights under this Agreement, will be effective unless in writing signed by the party to be charged. Any subsequent change or changes in my duties, salary or compensation will not affect the validity or scope of this Agreement. 4 19 (c) SEVERABILITY. If one or more of the provisions in this Agreement are deemed void by law, then the remaining provisions will continue in full force and effect. (d) SUCCESSORS AND ASSIGNS. This Agreement will be binding upon my heirs, executors, administrators and other legal representatives and will be for the benefit of ARRIS, its successors, and its assigns. Date: 11/4/94 Signature: /s/ Michael C. Venuti ------------------------------ ------------------------ Michael C. Venuti -------------------------------- Name of Employee (typed or printed) ARRIS Pharmaceuticals, Inc. Name: /s/ Linda Ballenger ------------------------------- Print Name: Linda Ballenger ------------------------- Title: Comp. & Benefits Manager ----------------------------- 5 20 EXHIBIT A LIST OF PRIOR INVENTIONS AND ORIGINAL WORKS OF AUTHORSHIP Identifying # or Title __________________________________ Date _______________ Brief Description X No inventions or improvements _____ Additional sheets attached Signature of Employee /s/ Michael C. Venuti ---------------------- Print Name of Employee Michael C. Venuti ---------------------- Date 11/4/94 ------- Signature of Supervisor Heinz Gschwend ------------------ Print Name of Supervisor Heinz Gschwend ------------------ Date 11/9/94 ------- 6 21 EXHIBIT B CALIFORNIA LABOR CODE SECTION 2870 EMPLOYMENT AGREEMENTS; ASSIGNMENT OF RIGHTS "(a) Any provision in an employment agreement which provides that an employee shall assign, or offer to assign, any of his or her rights in an invention to his or her employer shall not apply to an invention that the employee developed entirely on his or her own time without using the employer's equipment, supplies, facilities, or trade secret information except for those inventions that either: (1) Relate at the time of conception or reduction to practice of the invention to the employer's business, or actual or demonstrably anticipated research or development of the employer. (2) Result from any work performed by the employee for the employer. (3) To the extent a provision in an employee agreement purports to require an employee to assign an invention otherwise excluded from being required to be assigned under subdivision (a), the provision is against the public policy of this state and is unenforceable." 7 EX-23.1 7 CONSENT OF ERNST & YOUNG 1 Exhibit 23.1 Consent of Ernst & Young LLP, Independent Auditors We consent to the incorporation by reference in the Registration Statements (Form S-8 Nos. 33-74720, 33-80852, 333-09095, 333-44667, 333-44669, 333-36639, 33-92900, 333-00500, 333-36645 and 333-84199) pertaining to the 1989 Stock Plan, 1993 Employee Stock Purchase Plan, 1993 Employee Stock Bonus Plan, 1994 Non-Employee Directors' Stock Option Plan, 1997 Equity Incentive Plan and 1997 Non-Officer Equity Incentive Plan of Axys Pharmaceuticals, Inc. of our report dated February 18, 2000 with respect to the consolidated financial statements of Axys Pharmaceuticals, Inc. included in the Annual Report (Form 10-K) for the year ended December 31, 1999. ERNST & YOUNG LLP Palo Alto, California March 7, 2000 EX-27 8 FINANCIAL DATA SCHEDULE
5 This schedule contains summary financial information extracted from the consolidated balance sheets, statements of operations and statements of cash flows included in the Company's Form 10-K for the year ended December 31, 1999, and is qualified in its entirety by reference to such financial statements and notes thereto. 1,000 12-MOS DEC-31-1999 JAN-01-1999 DEC-31-1999 23,577 3,080 4,786 0 2,258 35,225 48,608 (29,735) 55,734 38,556 0 0 0 291,328 14,047 55,734 12,928 38,257 2,698 0 84,772 0 2,086 (49,763) 0 (49,763) 0 0 0 (49,763) (1.60) (1.60)
-----END PRIVACY-ENHANCED MESSAGE-----