-----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, JoZ013c2GDe9ZP0X77P5g623b9Rue2kx1mSPks1WYJv//oJRpZbkEN8oAvJ/XTL1 h5GhSsO84K2a8xDJ9/ZeAQ== 0000936392-97-000450.txt : 19970401 0000936392-97-000450.hdr.sgml : 19970401 ACCESSION NUMBER: 0000936392-97-000450 CONFORMED SUBMISSION TYPE: 10-K405 PUBLIC DOCUMENT COUNT: 6 CONFORMED PERIOD OF REPORT: 19961231 FILED AS OF DATE: 19970331 SROS: NASD FILER: COMPANY DATA: COMPANY CONFORMED NAME: LA JOLLA PHARMACEUTICAL CO CENTRAL INDEX KEY: 0000920465 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 330361285 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-K405 SEC ACT: 1934 Act SEC FILE NUMBER: 000-24274 FILM NUMBER: 97570904 BUSINESS ADDRESS: STREET 1: 6455 NANCY RIDGE DR CITY: SAN DIEGO STATE: CA ZIP: 92121 BUSINESS PHONE: 6194526600 MAIL ADDRESS: STREET 1: 6455 NANCY RIDGE DR CITY: SAN DIEGO STATE: CA ZIP: 92121 10-K405 1 FORM 10-K405 1 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K [X] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 [NO FEE REQUIRED] For the fiscal year ended DECEMBER 31, 1996 [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 [NO FEE REQUIRED] For the transition period from _______________ to _______________ Commission file number 0-24274 LA JOLLA PHARMACEUTICAL COMPANY (Exact name of registrant as specified in its charter) DELAWARE 33-0361285 (State or other jurisdiction of incorporation of organization) (I.R.S. Employer Identification No.)
6455 NANCY RIDGE DRIVE, SAN DIEGO, CA 92121 Address of principal executive offices (619) 452-6600 Registrant's telephone number, including area code Securities registered pursuant to Section 12(b) of the Act: None Securities registered pursuant to Section 12(g) of the Act: Common Stock, par value $0.01 Warrants
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes [X] No [ ] Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of registrant's knowledge, in definitive proxy or information statements incorporated by reference in Part III of the Form 10-K or any amendment to this Form 10-K. [X] The aggregate market value of the voting stock held by non-affiliates of the Registrant, computed by reference to the closing price of such stock on the Nasdaq Stock Market on March 17, 1997, was $84,239,488. The number of shares of the Registrant's common stock, $.01 par value, outstanding at March 17, 1997 was 17,279,895. DOCUMENTS INCORPORATED BY REFERENCE Part III incorporates certain information by reference from the Registrant's definitive proxy statement for its annual meeting of stockholders to be held on May 13, 1997, which proxy statement will be filed on or about March 31, 1997. 1 2 FORWARD-LOOKING STATEMENTS This Report includes forward-looking statements, including without limitation those dealing with the Company's drug development plans and clinical trials, its relationship with Abbott Laboratories ("Abbott"), and other matters described in terms of the Company's plans and expectations. The forward-looking statements in this Report involve risks and uncertainties, and a number of factors, both foreseen and unforeseen, which could cause actual results to differ from the Company's current expectations. The Company's ongoing Phase II/III clinical trial of LJP 394, the Company's drug candidate for the treatment of lupus, could result in a finding that LJP 394 is not effective in producing a sustained reduction of dsDNA antibodies in large patient populations or does not provide a meaningful clinical benefit. The Company's other potential drug candidates are at earlier stages of development and involve comparable risks. Payments by Abbott to the Company are contingent upon progress of clinical trials and the Company's achievement of certain other milestones that might not be met. The relationship with Abbott could be terminated by either party for various reasons. Clinical trials could be delayed and could have negative or inconclusive results. Additional risk factors include the uncertainty of future revenue from product sales or other sources such as collaborative relationships, the uncertainty of future profitability, the Company's dependence on patents and other proprietary rights, the Company's limited manufacturing capabilities and the Company's lack of marketing experience. Readers are cautioned not to place undue reliance upon forward-looking statements, which speak only as of the date hereof, and the Company undertakes no obligation to update forward-looking statements to reflect events or circumstances occurring after the date hereof. Interested parties are urged to review the risks described below under the heading "Certain Risk Factors" and elsewhere in this Report and in other reports and registration statements of the Company filed with the SEC from time to time. PART I ITEM 1. BUSINESS OVERVIEW La Jolla Pharmaceutical Company is a biopharmaceutical company focused on the research and development of highly specific therapeutics for the treatment of certain life-threatening antibody-mediated diseases. These diseases, including autoimmune conditions such as lupus and antibody-mediated stroke, are caused by abnormal B cell production of antibodies that attack healthy tissues. Current therapies for these autoimmune disorders only address symptoms of the disease or nonspecifically suppress the normal operation of the immune system, which often results in severe, adverse side effects and hospitalization. The Company believes that its drug candidates, called Toleragens, will treat the underlying cause of many antibody-mediated diseases without these severe, adverse side effects. The Company is currently conducting a Phase II/III pivotal clinical trial initiated in December 1996 for its lupus drug candidate, LJP 394. 2 3 ANTIBODY-MEDIATED DISEASES The immune system is the major biological defense mechanism responsible for recognizing and fighting disease. The immune system identifies antigens, such as bacteria, viruses and other disease-causing substances, and seeks to rid the body of these antigens. There are two fundamental types of immune responses: cell-mediated and antibody-mediated. Cell-mediated immunity is primarily responsible for ridding the body of cells that have become infected. Antibody-mediated immunity is primarily responsible for eliminating circulating antigens. These immune responses are controlled by the activities of white blood cells called T cells and B cells. T cells provide cell-mediated immunity and regulate B cells. B cells produce antibodies that recognize and help to eliminate antigens. Each B cell produces antibodies against a specific structure on the antigen's surface called an epitope. The B cell is triggered to produce antibodies when the specific epitope is recognized by and binds to the antibody receptors on the surface of the B cell and only when the B cell receives an appropriate signal from a T cell. When an epitope binds to the B cell with no corresponding T cell signal, the B cell may become "tolerized" and cease to produce antibodies. A properly functioning immune system distinguishes between antigens and the body's healthy tissues. In a malfunctioning immune system, healthy tissue may trigger an immune response that causes B cells to produce disease-causing antibodies, resulting in antibody-mediated autoimmune disease. For example, B cells can produce disease-causing antibodies that are associated with the destruction of the kidneys in lupus and the wasting of muscles in myasthenia gravis. Other antibody-mediated disorders include antibody-mediated stroke, heart attacks, deep vein thrombosis, recurrent fetal loss, Rh hemolytic disease of the newborn and Graves' disease. Current therapies for antibody-mediated diseases have significant shortcomings, including severe side effects and a lack of specificity. Mild forms of antibody-mediated diseases are generally treated with drugs that address only the disease symptoms and fail to suppress disease progression because they do not control the production of disease-causing antibodies. Severe antibody-mediated diseases are generally treated with high levels of steroids and immunosuppressive therapy (primarily anti-cancer drugs) which broadly suppress the normal function of the entire immune system. These therapies can leave patients susceptible to potentially life-threatening infections that may require hospitalization. Repeated dosing with steroids may cause other serious conditions, including diabetes, hypertension, cataracts, osteoporosis and psychosis, that may limit the use of this therapy. The use of chemotherapy may lead to acute problems, including weight loss and nausea, and long-term adverse effects, including sterility and an increased risk of malignancies. LJP'S TOLERANCE TECHNOLOGY PROGRAM The Company's Tolerance Technology program focuses on the discovery and development of proprietary therapeutics, called Toleragens, which target and suppress the production of specific disease-causing antibodies without affecting the protective functions of the immune system. The Company believes that its Toleragens will treat the underlying causes of antibody-mediated diseases, and that its Tolerance Technology can be applied broadly wherever antibodies are involved in the disease process. 3 4 Toleragens are composed of disease-specific epitopes and a carrier platform, which are proprietary chemical structures developed and synthesized by the Company. To mimic the unique epitopes on an antigen's surface, LJP identifies and synthesizes epitopes specific to particular antibody-mediated diseases and attaches or conjugates these epitopes to the carrier platform, which serves as a vehicle for presenting the epitopes to the antibody receptors on the targeted B cell. When the epitope binds to the antibody receptors on the B cell in the absence of a T cell signal, the B cell may become tolerized and cease to produce disease-causing antibodies. The Company believes that the Toleragen carrier platform, or a modification thereof, can be used with epitopes specific to other diseases to create additional therapeutics targeted at different antibody-mediated diseases. The Company designs its Toleragens to bind selectively to disease-causing B cells without affecting the function of disease-fighting B cells. This process involves: (i) collecting and purifying the disease-causing antibodies from patients with the targeted disease; (ii) generating and selecting an epitope that strongly binds to the purified antibodies; (iii) modifying the epitope's structure to maximize its binding properties (optimization) and (iv) linking the optimized epitope to the carrier platform. The Company believes this process enables the Company to create Toleragens that will preferentially tolerize and shut down B cells that generate antibodies with the highest binding affinity, which are believed to be the most harmful. To achieve this process, the Company utilizes advanced technologies in order to identify suitable epitopes that will bind to targeted disease-causing B cells. These technologies include: Combinatorial Epitope Libraries. Since 1991, the Company has been developing epitope libraries to provide a large and diverse pool of epitope candidates for screening. Each library is a collection of billions of different epitopes that are created by introducing random sequences of DNA into bacterial viruses. These DNA sequences direct the viruses to express a wide variety of epitopes on their surfaces. LJP has used these libraries in the development of drug candidates for lupus, antibody-mediated stroke, heart attack, deep vein thrombosis, recurrent fetal loss, Rh hemolytic disease and myasthenia gravis. Molecular Modeling Capabilities. The Company uses nuclear magnetic resonance spectroscopy (NMR) and molecular modeling software to determine and analyze important three-dimensional structural features of epitopes and the related disease-causing antibodies. These capabilities permit further optimization of epitopes to increase their binding to targeted B cells. Disease-Specific Screening Methods and Assays. The Company clones and expresses receptors that are associated with the targeted disease to screen the disease-causing antibodies from patient blood. After screening, these antibodies are presented to the epitope libraries through a series of assays in order to identify suitable epitope candidates. Using these methods, the Company more rapidly and efficiently selects lead epitope candidates with the highest antibody binding affinity. Chemical Optimization Expertise. The Company optimizes each lead epitope candidate by changing its chemical structure. These changes to the molecule increase its binding affinity and stability. The Company then attaches multiple copies of the lead epitope to the carrier platform to create a Toleragen. The Company's carrier platform technology provides a stable presentation of multiple copies of the epitope in an optimal configuration that increases binding affinity and thus tolerization of B cells. 4 5 BUSINESS STRATEGY The Company's objective is to become the leading developer of highly specific therapeutics for the treatment of life-threatening antibody-mediated disorders such as lupus, antibody-mediated stroke, recurrent fetal loss, deep vein thrombosis, Rh hemolytic disease of the newborn, myasthenia gravis, heart attack and Graves' disease. The Company's strategy includes the following key elements: Complete Clinical Development of LJP 394. The Company's primary near-term goal is to complete development of LJP 394 to treat lupus. The Company initiated a pivotal Phase II/III clinical trial in December 1996 to evaluate the safety and efficacy of the drug in a larger population of patients. Apply Tolerance Technology to Life-threatening Antibody-mediated Diseases. The Company is focusing on chronic, life-threatening antibody-mediated diseases, such as lupus, for which there are no existing treatments or for which current therapeutics have significant limitations. The Company intends to use its Tolerance Technology to design therapeutics that specifically address other targeted antibody-mediated diseases without adversely affecting normal immune system function. Utilize Strategic Alliances to Develop and Commercialize Product Candidates. The Company has a strategic alliance with Abbott for the worldwide development and commercialization of LJP 394, and intends to seek appropriate collaborations with other pharmaceutical companies to provide support for its research programs and the clinical development and commercialization of other drug candidates. Exploit Proprietary Manufacturing Technology. Through the production of LJP 394 for clinical trials, the Company has developed proprietary synthesis and conjugation technologies that are being used in the development of its other Toleragen candidates. The Company intends to further develop these technologies in order to increase manufacturing efficiencies and to apply its know-how to the development and manufacture of other potential products. Expand Intellectual Property Leadership Position. The Company owns nine issued patents and has filed 37 patent applications covering the Company's Tolerance Technology and its lupus and antibody-mediated stroke drug candidates. The Company plans to broaden this position with further discoveries and patent filings. PRODUCTS UNDER DEVELOPMENT The Lupus Program Lupus is a life-threatening antibody-mediated disease in which disease-causing antibodies damage various tissues. According to recent information compiled by the Lupus Foundation of America and other sources and epidemiological studies conducted in the 1970s, the number of lupus patients in the United States is between 250,000 and 1,000,000, with 16,000 new cases diagnosed each year. Approximately nine out of 10 lupus patients are women, who usually develop the disease during their childbearing years. Lupus is characterized by a number of symptoms, including chronic kidney inflammation, which can lead to kidney failure, and serious episodes of cardiac and central nervous system inflammation, as well as arthritis and 5 6 rashes. Approximately 80% of patients will progress to more serious disease symptoms, and approximately 50% of lupus patients have renal involvement. Antibodies to double-stranded DNA ("dsDNA") can be detected in approximately 90% of untreated lupus patients, and are widely believed to cause kidney disease (nephritis), often resulting in morbidity and mortality in lupus patients. These antibodies are also associated with episodes of potentially life-threatening inflammation called flares, which may occur more than once per year and usually require intensive care hospitalization. Significant kidney destruction occurs during flares. Lupus nephritis can lead to deterioration of kidney function and end-stage kidney disease, requiring long-term renal dialysis or kidney transplantation. Current treatments for lupus patients with kidney disease and other serious symptoms usually include repeated administration of steroids, often at high levels that can have toxic effects when used as a chronic treatment regimen. Many patients with advanced disease are also treated with immunosuppressive therapy, including anti-cancer drugs, that have a general suppressive effect on the immune system and may be carcinogenic. This immunosuppressive treatment leaves the patient vulnerable to serious infection and is a significant cause of morbidity and mortality. The Company has designed LJP 394 to suppress the production of antibodies to dsDNA in lupus patients without suppressing the normal function of the immune system. The design of LJP 394 is based upon scientific evidence of the role of antibodies to dsDNA in lupus. A recent study indicated that a rise in the level of antibodies to dsDNA may be predictive of flares in lupus patients with renal involvement, and that suppressing antibodies to dsDNA by treating these patients with steroids that non-specifically lower antibody levels prevents relapses in a majority of patients. In a mouse model of lupus nephritis that generates elevated levels of antibodies to dsDNA, administration of LJP 394 reduced the production of antibodies to dsDNA, reduced the number of antibody forming cells, and reduced kidney disease while extending the life of the animals. The Company believes that its own and other studies provide evidence that inhibiting antibodies to dsDNA may provide an effective therapy for lupus nephritis. Certain studies of lupus patients indicate that antibodies to dsDNA with the highest binding affinity are associated with the most damage to the kidneys. The Company believes that its Tolerance Technology process preferentially targets these antibodies. Results of Clinical Trials Based on its preclinical findings, the Company filed an IND application for LJP 394 with the FDA in August 1994. In a double-blind, placebo-controlled Phase I clinical trial in December 1994, healthy volunteers received LJP 394 and displayed no significant drug-related adverse effects and no immune reaction to the drug. The Company's Phase II clinical trials included a single-dose trial, a repeat escalating-dose trial, and a dose-ranging trial. The single-dose clinical trial evaluated the safety of a single, 100 mg intravenous dose of LJP 394 in four female lupus patients by monitoring antibody levels, blood chemistry, vital signs and complement (inflammation-promoting proteins) levels for 28 days after dosing. LJP 394 was well tolerated by all four patients, with no drug-related adverse clinical symptoms and no clinically significant complement level changes. In addition, no clinically significant immune complex formation (inflammation-promoting accumulation of 6 7 antibodies and antigens) was observed, indicating the absence of an adverse immune response to LJP 394. A transient reduction in dsDNA antibody levels was also observed. These results were presented at the American College of Rheumatology Conference in October 1995. The repeat escalating-dose clinical trial involved two female patients, each receiving doses of 10, 10, 50, 50, 100 and 100 mg of LJP 394 at two-week intervals. After the 10-week dosing regimen, patients were followed for six weeks. LJP 394 was well tolerated with no drug-related adverse clinical symptoms, no clinically significant complement changes, and no significant immune complex formation. Six weeks after the last dose, the antibody levels in both patients remained suppressed below baseline levels. The dose-ranging trial evaluated 58 patients with mild lupus symptoms (53 females and five males). All patients were clinically stable and had dsDNA antibody levels exceeding those generally found in healthy individuals. The patients were organized into nine treatment groups at three dose levels (1 mg, 10 mg and 50 mg), and three frequencies (once per week, once every two weeks and once every four weeks). Patients were randomized to one of the nine treatment groups so that at each dose and frequency, four to seven patients received LJP 394 and one patient received a placebo. Patients in the weekly treatment groups showed a dose-response correlation between increasing doses of LJP 394 and reductions of levels of dsDNA antibodies. In patients treated weekly with 10 mg or 50 mg doses of LJP 394, antibodies to dsDNA were reduced by statistically significant levels and remained suppressed in certain patients for up to two months after the last dose. In the patient group treated weekly with 50 mg, the reductions in median levels of dsDNA antibodies were accompanied by increases in median levels of two important inflammation-related complement proteins, C3 and C4, which normally decrease during active lupus renal disease and increase with clinical improvement. These study data suggest that complement levels and antibody levels were normalizing in parallel. Throughout the dose-ranging trial, the drug was well tolerated with no clinically significant dose-related adverse reactions observed. Three patients who began the study experienced lupus flares, and three other patients were hospitalized as a result of transient adverse events that the treating clinicians believed were unrelated to the underlying disease or LJP 394. Two of the patients with flares withdrew from the study, as did four patients who experienced exacerbations of lupus and one patient with herpes rash. However, no relationship was observed between the development of an adverse event and the dose or frequency of administration of LJP 394. In December 1996, the Company initiated a pivotal, multicenter Phase II/III clinical trial of LJP 394 in an expanded population of approximately 300 lupus patients. The purpose of the trial is to evaluate the safety of the drug and its potential to prevent renal flares, reduce disease severity and the need for immunosuppressive steroids/chemotherapy drugs and hospitalization, and improve patients' quality of life. The trial is being conducted in collaboration with Abbott and is expected to take at least two years. This is a double-blind trial and the Company does not expect to announce interim results. The trial and the development of LJP 394 in general involve many risks and uncertainties, and there can be no assurance that any interim clinical results can be replicated in further clinical testing or that LJP 394 will be effective in inducing and sustaining antibody suppression, will prove to be clinically safe or effective, or will receive required regulatory approvals. If the Phase II/III trial produces negative or inconclusive results, 7 8 the Company's business and financial condition will be adversely affected and it may be difficult or impossible for the Company to survive. Antibody-Mediated Stroke and Recurrent Fetal Loss Researchers believe that anticardiolipin antibodies promote arterial and venous blood clots, which can cause a variety of life-threatening medical problems. For example, blood clots that lodge in the brain cause stroke and those that lodge in the legs cause deep vein thrombosis. There are at least six diseases associated with these antibodies: antibody-mediated stroke, heart attack, recurrent fetal loss, thrombocytopenia (platelet deficiencies), deep vein thrombosis, and complications following cardiovascular surgery. The Company's program to develop a Toleragen to treat anticardiolipin antibodies targets stroke, myocardial infarction, deep vein thrombosis, post operative complications, and recurrent fetal loss. These antibodies have been shown to promote the formation of blood clots leading to multiple, recurring, and potentially life threatening conditions. Stroke is a leading cause of death in the United States. In 1994, there were approximately two million stroke patients in the United States, approximately 500,000 new episodes occurred and approximately 150,000 people died from stroke. This debilitating condition results from acute neurological injury caused by the blockage or rupture of blood vessels in the brain. Many of the blockages are caused by thromboses (blood clots), which clinicians believe may be caused by a number of factors including a class of antibodies called anticardiolipin antibodies, which can be identified and measured by a clinical laboratory assay. It is estimated that 5 to 10% of the strokes in the United States (affecting 100,000 to 200,000 patients) are caused by these antibodies. Antibody-mediated stroke is thought to occur in younger individuals and with greater frequency than non-antibody-mediated stroke. The cost of treatment for a survivor of a serious stroke is approximately $30,000 per year for life, consisting of hospitalization and home nursing care costs. Anticardiolipin antibodies are also associated with recurrent fetal loss, a major cause of repeated miscarriage. Published clinical reports estimate that many women with elevated anticardiolipin antibody levels experience multiple miscarriages, delayed fetal development or premature childbirth. Elevated levels of anticardiolipin antibodies are also found in approximately 30% of patients with other clotting disorders, including myocardial infarction (heart attack), deep vein thrombosis, thrombocytopenia (platelet deficiency), cardiac valve lesion as well as in approximately 30% of lupus patients. In myocardial infarction, the relative risk of having an event or death is twice as high in people with high anticardiolipin antibodies and this risk is independent of other risk factors. In deep vein thrombosis, anticardiolipin antibody positive patients have recurring deep vein thromboses twice as often as anticardiolipin antibody-negative patients. Current treatments for antibody-mediated thrombosis involve the use of steroids and chronic, potentially life-long anticoagulant therapy with drugs such as heparin or warfarin to prevent the formation of blood clots. Patients must be carefully monitored to minimize serious bleeding episodes which can occur because of the therapy. If patients are removed from anticoagulant therapy, they are at an increased risk of stroke or another thrombotic episode. Warfarin is not recommended in the treatment of recurrent fetal loss because it is toxic to the developing fetus. 8 9 The Company believes that a Toleragen that binds to B cells producing anticardiolipin antibodies may suppress antibody production and prevent or reduce antibody-associated blood clots. To develop such a Toleragen, the Company established a supply of blood samples from representative stroke and recurrent fetal loss patients and purified antibodies from these samples. We have used these blood samples to identify several epitopes that react with a subset of patients and have built one Tolergen candidate. We continue our efforts to identify and optimize more broadly cross-reactive epitopes prior to developing a potential Toleragen candidate. Rh Hemolytic Disease of the Newborn Rh hemolytic disease of the newborn is a life-threatening fetal condition characterized by the hemolysis (destruction) of fetal red blood cells. This condition occurs in Rh incompatible pregnancies in which maternal antibodies to Rh cross the placenta, bind to fetal red blood cells and cause their destruction. Rh is a family of proteins on the surface of red blood cells. When the most common form of these proteins is present, the blood type is Rh(+), and when it is absent, the blood type is Rh(-). A pregnancy is "Rh incompatible" when the fetus is Rh(+) and the mother is Rh(-). Each year approximately 500,000 women in the United States have Rh incompatible pregnancies. Despite current treatments that attempt to control maternal immune systems with immunoglobulin, approximately 5,000 of these women each year begin producing antibodies against fetal red blood cells and therefore become part of the existing pool of patients who are at risk of developing Rh hemolytic disease in a subsequent pregnancy. Every year approximately 5,000 women from this pool of patients have pregnancies that result in severe cases of Rh hemolytic disease, which can result in loss of the fetus. This condition is treated by intrauterine fetal blood transfusions and associated amniocentesis procedures, which are usually repeated several times prior to birth, are risky to the fetus and mother, and can cost more than $30,000 during the course of a pregnancy. The Company believes that these women, as well as others who produce Rh antibodies and avoid pregnancy altogether, could be treated with an Rh Toleragen. The Company believes that a Toleragen that binds to the appropriate maternal B cells will suppress Rh antibody production, and that once the level of antibodies to Rh(+) red blood cells is reduced, the risk of life-threatening hemolysis will be eliminated. LJP has purified antibodies to Rh from blood samples taken from sensitized patients and has identified several epitopes bound by antibodies to Rh. The Company is currently using its epitope libraries to screen and further define these epitopes, with the expectation of using selected epitopes to synthesize lead Toleragens. Other Antibody-Mediated Diseases The Company believes its Tolerance Technology may be applicable to many diseases and conditions caused by the production of disease-causing antibodies, including myasthenia gravis and Graves' disease. Myasthenia gravis is a form of muscular paralysis in which neuromuscular receptors are attacked by antibodies, which can lead to a wasting of muscles, progressive loss of strength and life-threatening respiratory arrest. This disease affected an estimated 20,000 people in the United States in 1994. Graves' disease is caused by antibodies 9 10 that bind to the thyroid stimulating hormone receptor and stimulate excessive production of thyroid hormones, which results in hyperthyroidism (including potentially life-threatening increases in heart rate, blood pressure and body temperature). Graves' disease affected over one million people in the United States in 1987. The Company has cloned human receptors for acetylcholine (for myasthenia gravis) and thyroid stimulating hormone (for Graves' disease), which can be used to purify antibodies from the blood of patients in order to identify potential epitope candidates. COLLABORATIVE ARRANGEMENTS As part of its business strategy, the Company pursues collaborations with pharmaceutical companies in an effort to access their research, drug development, manufacturing, marketing and financial resources. In December 1996, the Company entered into a collaborative relationship with Abbott for worldwide development and commercialization of LJP 394. Under the terms of a license and supply agreement between Abbott and the Company, Abbott obtained the exclusive right to market and sell LJP 394 throughout the world, and the Company retained manufacturing rights and ownership of all of its patents relating to the drug. Abbott will pay escalating royalties to the Company on sales of LJP 394, with additional premiums payable if specified sales levels are achieved. Abbott will also purchase the drug in bulk form from the Company at prices calculated as a percentage of Abbott's net sales. Abbott will pay future clinical development costs and is responsible for obtaining worldwide regulatory approvals. Pending regulatory approval, Abbott and the Company will cooperate in development and clinical trials for the drug, and Abbott will pay development costs incurred by the Company in accordance with a development plan and budgets to be mutually agreed upon. Abbott will handle marketing activities throughout the world, with cooperation and assistance from the Company. The Company is obligated to develop appropriate manufacturing capabilities and conduct patent prosecution in the major markets of the world. Concurrently with the formation of the collaborative relationship, Abbott made an initial $4 million license payment to the Company and purchased 1,000,050 shares of LJP's common stock for gross proceeds of $4.0 million. Abbott is obligated to make milestone payments upon the attainment of various performance and regulatory objectives and the Company has the right to require Abbott to purchase up to $4.0 million in LJP common stock in each of calendar 1997 and 1998. Both Abbott and the Company have the right to terminate the agreement under certain circumstances. The Company intends to pursue collaborative arrangements with other pharmaceutical companies to assist in its research programs and the clinical development and commercialization of other drug candidates. There can be no assurance that the Company will be able to negotiate arrangements with any other collaborative partners on acceptable terms, if at all, and any additional collaborative relationships are likely to include contingencies comparable to those affecting the Abbott relationship. Once a collaborative relationship is established, there can be no assurance that the collaborative partner will continue funding any particular program or will not pursue alternative technologies or develop alternative drug candidates, either individually or in collaboration with others, including the Company's competitors, as a means for developing treatments for the diseases targeted by the Company. Furthermore, competing products, either developed by a collaborative partner or to which a collaborative partner has rights, may result in 10 11 the withdrawal of support by the collaborative partner with respect to all or a portion of the Company's technology. Failure to establish or maintain collaborative arrangements will require the Company to fund its own research and development activities, resulting in accelerated depletion of the Company's capital, and will require the Company to develop its own marketing capabilities for any drug candidate that may receive regulatory approval. The failure of any collaborative partner to continue funding any particular program of the Company or to commercialize successfully any product could delay or halt the development or commercialization of any products involved in such program. As a result, failure to establish or maintain collaborative arrangements could have a material adverse effect on the Company's business, financial condition and results of operations. MANUFACTURING The Company has constructed and is presently operating a pilot production plant for the manufacture of LJP 394 for clinical trials. Through internal development programs and external collaborations, the Company has made several improvements to the manufacturing process for LJP 394 that have reduced costs and increased capacity, and the Company believes sufficient capacity now exists to meet its anticipated research and clinical trial needs for LJP 394. The Company has developed proprietary synthesis and conjugation technologies that are being used in the development of its other Toleragen candidates. The Company intends to further develop these technologies in order to increase manufacturing efficiencies and apply its know-how to the development and manufacture of other potential products. However, the Company's current facilities are not yet adequate for commercial production. In order to meet its obligations to supply all LJP 394 in bulk form to Abbott for packaging and commercial resale, the Company will be required to invest substantial amounts of capital in the expansion of its facilities. The manufacture of the Company's potential products for clinical trials and the manufacture of any resulting products for commercial purposes is subject to cGMP as defined by the FDA. The Company has never operated an FDA-approved manufacturing facility, and there can be no assurance that it will obtain the necessary approvals. The Company has limited manufacturing experience, and no assurance can be given that it will be able to make the transition to commercial production successfully. The Company may enter into arrangements with contract manufacturers to expand its own production capacity in order to meet requirements for its products, or to attempt to improve manufacturing efficiency. If the Company chooses to contract for manufacturing services and encounters delays or difficulties in establishing relationships with manufacturers to produce, package and distribute its finished products, clinical trials, market introduction and subsequent sales of such products would be adversely affected. Moreover, contract manufacturers must operate in compliance with the FDA's cGMP requirements. The Company's potential dependence upon third parties for the manufacture of its products may adversely affect the Company's profit margins and its ability to develop and deliver such products on a timely and competitive basis. MARKETING AND SALES In order to commercialize any drug candidate approved by the FDA, the Company must either develop a marketing and sales force or enter into marketing arrangements with third parties. Such arrangements may be exclusive or nonexclusive and may provide for marketing 11 12 rights worldwide or in a specific market. Abbott has agreed to be responsible for worldwide marketing of LJP 394, but the Abbott agreement may terminate under certain circumstances and the Company has no arrangements with third parties for marketing of any other drug candidates. There can be no assurance that the Company will be able to enter into any additional marketing agreements on terms favorable to the Company, if at all, or that any such agreements that the Company may enter into will result in payments to the Company. Under the Abbott agreement and any co-promotion or other marketing and sales arrangements that may be entered into with other companies, any revenues to be received by the Company will be dependent on the efforts of others and there can be no assurance that such efforts will be successful. To the extent that the Company chooses to attempt to develop its own marketing and sales capability, it will compete with other companies that currently have experienced and well-funded marketing and sales operations. Furthermore, there can be no assurance that the Company or any collaborative partner will be able to establish sales and distribution capabilities without undue delays or expenditures or gain market acceptance for any of the Company's drug candidates. PATENTS AND PROPRIETARY TECHNOLOGIES The Company files patent applications in the United States and in foreign countries, as it deems appropriate, for protection of its proprietary technologies and drug candidates. The Company owns nine issued patents and has filed 37 patent applications covering its Tolerance Technology and its lupus and antibody-mediated stroke drug candidates. The Company's issued patents include four issued United States patents and one issued Australian patent concerning its lupus Toleragens (expiring in 2009, 2011, 2013, 2014 and 2011, respectively), one issued United States patent concerning its overall Tolerance Technology (expiring in 2010) and one United States patent (expiring in 2012) on linkage chemistries for its Toleragens. The Company has received Notices of Intent to grant a European patent (expiring in 2011) on its lupus Toleragens and a European patent (expiring in 2012) on its overall Tolerance Technology, and has also received a Notice of Allowance from the Japanese patent office (expiring in 2012) on its overall Tolerance Technology. The Company also has an option to obtain the exclusive license to several issued United States patents and related technology concerning compounds that may be used in the potential treatment of muscular dystrophies or myasthenia gravis. The Company's decision to exercise the option, which will require payment of a nonrefundable advance against future royalties of $100,000, will be made based upon the results of future studies of this technology. The Company's success will depend upon its ability to obtain patent protection for its therapeutic approaches and for any developed products, to preserve its trade secrets and to operate without infringing the proprietary rights of third parties. While the Company has received patents covering certain aspects of its technology, there can be no assurance that any additional patents will be issued, that the scope of any patent protection will be sufficient, or that any current or future issued patents will be held valid if subsequently challenged. There is a substantial backlog of biotechnology patent applications at the USPTO that may delay the review and issuance of any patents. The patent position of biotechnology firms generally is highly uncertain and involves complex legal and factual questions, and no consistent policy has emerged regarding the breadth of claims covered in biotechnology patents or protection afforded by such patents. To date, the Company has rights to certain United States and foreign issued patents and has filed or participated as a licensee in the filing of a number of patent applications in the United States relating to the Company's technology, as well as foreign 12 13 counterparts of certain of these applications in certain countries. The Company intends to continue to file applications as appropriate for patents covering both its products and processes. There can be no assurance that patents will issue from any of these applications, or that claims allowed under issued patents will be sufficient to protect the Company's technology. Patent applications in the United States are maintained in secrecy until a patent issues, and the Company cannot be certain that others have not filed patent applications for technology covered by the Company's pending applications or that the Company was the first to invent, or to file patent applications for, such technology. Competitors may have filed applications for, or may have received patents and may obtain additional patents and proprietary rights relating to, compounds or processes that block or compete with those of the Company. A number of pharmaceutical and biotechnology companies and research and academic institutions have filed or may file patent applications, and have received or may receive patents, in the fields being pursued by the Company. Certain of these applications or patents may be competitive with the Company's applications or conflict in certain respects with claims made under the Company's applications. In particular, the Company is aware of one currently pending United States patent application that, if allowed, may contain claims covering subject matter that may be competitive or conflicting with the Company's patents and patent applications. Any conflict between the Company's patents and patent applications and patents or patent applications of third parties could result in a significant reduction of the coverage of the Company's existing patents or any future patents that may be issued. In addition, to determine the priority of inventions, the Company may have to participate in interference proceedings declared by the USPTO or in opposition, nullity or other proceedings before foreign agencies with respect to any of its existing patents or patent applications or any future patents or applications, which could result in substantial cost to the Company. Further, the Company may have to participate at substantial cost in International Trade Commission proceedings to abate importation of goods which would compete unfairly with products of the Company. If patents containing competitive or conflicting claims are issued to other parties and such claims are ultimately determined to be valid, there can be no assurance that the Company would be able to obtain licenses to these patents at a reasonable cost, if at all, or be able to develop or obtain alternative technology. The Company also relies upon unpatented trade secrets and improvements, unpatented know-how and continuing technological innovation to develop and maintain its competitive position, which it seeks to protect, in part, by confidentiality agreements with its commercial partners, collaborators, employees and consultants. The Company also has invention or patent assignment agreements with its employees and certain consultants. There can be no assurance that relevant inventions will not be developed by a person not bound by an invention assignment agreement, or that binding agreements will not be breached, that the Company will have adequate remedies for any breach, or that the Company's trade secrets will not otherwise become known or be independently discovered by competitors. In addition, the Company could incur substantial costs in defending against suits brought against it by others for infringement of intellectual property rights or in prosecuting suits which the Company might bring against other parties to protect its intellectual property rights. COMPETITION The biotechnology and pharmaceutical industries are subject to rapid technological change. Competition from domestic and foreign biotechnology companies, large pharmaceutical 13 14 companies and other institutions is intense and expected to increase. A number of companies are pursuing the development of pharmaceuticals in the Company's targeted areas. [These include Genelabs Technologies, Inc., which is conducting Phase III clinical trials of a hormone for the treatment of lupus, and other competitors that are working on third-generation steroids.] Other companies are in earlier stages of developing other potential therapies for lupus. In addition, there are many academic institutions, both public and private, engaged in activities relating to research and development of therapeutics for autoimmune, inflammatory and other diseases. Most of these companies and institutions have substantially greater facilities, resources, research and development capabilities, regulatory compliance expertise, and manufacturing and marketing capabilities than the Company. In addition, other technologies may in the future be the basis of competitive products. There can be no assurance that the Company's competitors will not develop or obtain regulatory approval for products more rapidly than the Company, or develop and market technologies and products that are more effective than those being developed by the Company or that would render the Company's technology and proposed products obsolete or noncompetitive. The Company believes that its ability to compete successfully will depend upon its ability to attract and retain experienced scientists, develop patented or proprietary technologies and products, obtain regulatory approvals, manufacture and market products either alone or through third parties, and secure additional capital resources to fund anticipated net losses for at least the next several years. The Company expects that competition among products approved for marketing will be based in large part upon product safety, efficacy, reliability, availability, price and patent position. GOVERNMENT REGULATION The Company's research and development activities and the future manufacturing and marketing of any products developed by the Company are subject to significant regulation by numerous government authorities in the United States and other countries. In the United States, the Federal Food, Drug and Cosmetic Act and the Public Health Service Act govern the testing, manufacture, safety, efficacy, labeling, storage, record keeping, approval, advertising and promotion of any products the Company may develop. In addition to FDA regulations, the Company is subject to other federal, state and local regulations such as the Occupational Safety and Health Act and the Environmental Protection Act as well as regulations governing the handling, use and disposal of radioactive and other hazardous materials used by the Company in its research activities. Product development and approval within this regulatory framework takes a number of years and involves the expenditure of substantial resources. In addition, this regulatory framework is subject to changes that may affect approval, delay an application or require additional expenditures by the Company. The steps required before a pharmaceutical compound may be marketed in the United States include (i) preclinical laboratory and animal testing, (ii) submission to the FDA of an IND application, which must become effective before clinical trials may commence, (iii) adequate and well-controlled clinical trials to establish the safety and efficacy of the drug, (iv) submission to the FDA of an NDA 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, and approved by, the FDA. Drug 14 15 product manufacturing establishments located in California also must be licensed by the State of California in compliance with separate regulatory requirements. Preclinical testing includes laboratory evaluation of product chemistry and animal studies to assess the safety and efficacy of the product and its formulation. The results of preclinical testing are submitted to the FDA as part of an IND and, unless the FDA objects, the IND will become effective 30 days following its receipt by the FDA. Clinical trials involve administration of the drug to healthy volunteers or to patients diagnosed with the condition for which the drug is being tested under the supervision of a qualified clinical investigator. Clinical trials are conducted in accordance with protocols that detail the objectives of the study, the parameters to be used to monitor safety and the efficacy criteria to be evaluated. Each protocol is submitted to the FDA as part of the IND. Each clinical trial is conducted under the auspices of an independent Institutional Review Board (the "IRB"). The IRB will consider, among other matters, ethical factors, the safety of human subjects and the possible liability of the institution. Clinical trials are typically conducted in three sequential phases, but the phases may overlap. In Phase I, the initial introduction of the drug into healthy human subjects, the drug is tested for safety (adverse effects), dosage tolerance, metabolism, distribution, excretion and clinical pharmacology. Phase II involves trials in a limited patient population to (i) characterize the actions of the drug in targeted indications, (ii) determine drug tolerance and optimal dosage and (iii) identify possible adverse side effects and safety risks. When a compound is found to be effective and to have an acceptable safety profile in Phase II clinical trials, Phase III clinical trials are undertaken to further evaluate and confirm clinical efficacy and safety within an expanded patient population at multiple clinical trial sites. The FDA reviews both the clinical plans and the results of the trials and may discontinue the trials at any time if significant safety issues arise. The results of preclinical testing and clinical trials are submitted to the FDA in the form of an NDA or Product License Application for marketing approval. The testing and approval process is likely to require substantial time and effort and there can be no assurance that any approval will be granted on a timely basis, if at all. In addition, the Company will be required to obtain separate regulatory approval for each indicated use of a drug. The approval process is affected by a number of factors, including the severity of the disease, the availability of alternative treatments and the risks and benefits demonstrated in clinical trials. Additional preclinical testing or clinical trials may be requested during the FDA review period and may delay marketing approval. After FDA approval for the initial indications, further clinical trials may be necessary to gain approval for the use of the product for additional indications. The FDA mandates that adverse effects be reported to the FDA and may also require post-marketing testing to monitor for adverse effects, which can involve significant expense. Among the conditions for FDA approval is the requirement that the prospective manufacturer's quality control and manufacturing procedures conform to the FDA's cGMP requirements. Domestic manufacturing facilities are subject to biennial FDA inspections and foreign manufacturing facilities are subject to periodic inspections by the FDA or foreign regulatory authorities. 15 16 The Company is also subject to numerous and varying foreign regulatory requirements governing the design and conduct of clinical trials and marketing approval for pharmaceutical products to be marketed outside of the United States. The approval procedure varies among countries and can involve additional testing, and the time required to obtain approval may differ from that required to obtain FDA approval. The foreign regulatory approval process includes all of the risks associated with obtaining FDA approval, and approval by the FDA does not ensure approval by the health authorities of any other country. EMPLOYEES The Company has 84 full-time employees (including 18 Ph.D.s and M.D.s.), 69 of whom are involved full-time in research, development and manufacturing scale-up activities. All of the Company's management have had prior experience with pharmaceutical, biotechnology or medical product companies. The Company believes that it has been successful in attracting skilled and experienced scientific personnel, but competition for such personnel is intense and there can be no assurance that the Company will be able to attract and retain the individuals needed. None of the Company's employees are covered by collective bargaining agreements, and management considers relations with the Company's employees to be good. LEGAL PROCEEDINGS The Company is not a party to any legal proceedings. CERTAIN RISK FACTORS The Company's business is subject to a number of risks, including but not limited to the following. Additional risks related to the Company are described in the preceding sections of this Report and in the section entitled "Management's Discussion and Analysis of Financial Condition and Results of Operations." UNCERTAINTIES RELATED TO CLINICAL TRIALS The Company must demonstrate that LJP 394, the Company's only drug candidate in clinical trials, is safe and effective for use in each target indication prior to applying for any regulatory approvals in any market. The results from preclinical testing and clinical trials of LJP 394 conducted to date may not be indicative of results that may be obtained in further clinical trials. A number of companies in the biopharmaceutical industry have suffered significant setbacks in advanced clinical trials, even after promising results in earlier trials. The rate of completion of the Company's clinical trials may be delayed by many factors, including slower than anticipated patient enrollment, a slower timetable as determined by the Company or a collaborative partner, or any other adverse event. During the course of clinical trials, patients can die or suffer other adverse medical effects for reasons that may not be related to the pharmaceutical agent being tested but which can nevertheless affect clinical trial results. There can be no assurance that the Company will be permitted by regulatory authorities in the U.S. or any other country to undertake additional clinical trials of LJP 394 or to initiate clinical trials of any other drug candidates, or that any clinical trials undertaken by the Company will be completed successfully within any particular time period, if at all. Any delays in, or termination of, the Company's clinical trial efforts would have a material adverse effect on the Company's 16 17 business, financial condition and results of operations. There also can be no assurance that LJP 394 or any other drug candidate of the Company will prove to be safe or effective in clinical trials, that LJP 394 or any other drug candidate of the Company will receive regulatory approval in any market for any indication, or that any clinical trials undertaken by the Company will result in marketable products. If LJP 394 is not shown to be safe and effective in clinical trials, the resulting delays in developing any other drug candidate and conducting related preclinical testing and clinical trials, as well as the need for additional financing, would have a material adverse effect on the Company's business, financial condition and results of operations. See "Business -- Products Under Development -- Results of Clinical Trials." EARLY STAGE OF PRODUCT DEVELOPMENT; TECHNOLOGICAL UNCERTAINTIES All of the Company's product development efforts are based upon unproven technologies and therapeutic approaches that have not been widely tested or used. To date, the Company's Tolerance Technology has been used only in the preclinical tests and clinical trials of LJP 394 conducted by the Company. Application of Tolerance Technology to antibody-mediated diseases other than lupus is in earlier discovery or preclinical research stages. LJP 394 and any other potential drug candidates of the Company will require significant additional research and development and are subject to significant risks. Potential products that appear to be promising at early stages of development may be ineffective or cause harmful side effects during preclinical testing or clinical trials, fail to receive necessary regulatory approvals, be difficult to manufacture, be uneconomical to produce (particularly if high doses are required), fail to achieve market acceptance or be precluded from commercialization by proprietary rights of third parties. There can be no assurance that the Company's product development efforts with respect to LJP 394 or any other drug candidate will be successfully completed, that required regulatory approvals will be obtained or that any product, if introduced, will be successfully marketed or achieve commercial acceptance. The mechanism of action utilized by LJP 394 is unproven in humans, and to date, no therapeutic products have been developed that target the activity of specific B cells. There can be no assurance that LJP 394 will reliably induce or sustain suppression of disease-causing antibodies, or that LJP 394 will prove to be safe or effective. Furthermore, clinical trials of LJP 394 may be viewed as a test of the Company's entire Tolerance Technology approach. If these clinical trials encounter problems or are otherwise unsuccessful, the applicability of the Company's Tolerance Technology to other antibody-mediated diseases will be highly uncertain. Therefore, there is significant risk that the Company's therapeutic approaches will not prove to be successful, and there can be no assurance that the Company's drug discovery technologies will result in any commercially successful products. See "Business -- Products Under Development." UNCERTAINTY OF COLLABORATIVE ARRANGEMENTS As part of its business strategy, the Company pursues collaborations with pharmaceutical companies in an effort to access their research, drug development, manufacturing, marketing and financial resources. In December 1996 the Company entered into a collaborative agreement with Abbott pursuant to which Abbott obtained the exclusive right to market and sell LJP 394 throughout the world in exchange for royalties on sales, development financing, and certain milestone payments. Abbott's obligations to make payments to the Company and to conduct development activities are contingent upon the progress of clinical trials and the 17 18 attainment of certain milestones related to regulatory approvals and sales levels. There can be no assurance that these contingencies will be met. Furthermore, Abbott has the right to terminate the relationship at any time based on documented safety or efficacy issues, and without cause within 90 days of receipt of the results of the pending Phase II/III clinical trial that was initiated in December 1996 and is expected to be completed some time in 1999. The Company intends to pursue collaborative arrangements with other pharmaceutical companies to assist in its research programs and the clinical development and commercialization of its other drug candidates. There can be no assurance that the Company will be able to negotiate arrangements with any other collaborative partners on acceptable terms, if at all, and any additional collaborative relationships are likely to include contingencies comparable to those affecting the Abbott arrangement. Once a collaborative arrangement is established, there can be no assurance that the collaborative partner will continue funding any particular program or will not pursue alternative technologies or develop alternative drug candidates, either individually or in collaboration with others, including the Company's competitors, as a means for developing treatments for the diseases targeted by the Company. Furthermore, competing products, either developed by a collaborative partner or to which a collaborative partner has rights, may result in the withdrawal of support by the collaborative partner with respect to all or a portion of the Company's technology. Failure to establish or maintain collaborative arrangements will require the Company to fund its own research and development activities, resulting in accelerated depletion of the Company's capital, and will require the Company to develop its own marketing capabilities for any drug candidate that may receive regulatory approval. The failure of any collaborative partner to continue funding any particular program of the Company or to commercialize successfully any product could delay or halt the development or commercialization of any products involved in such program. As a result, failure to establish or maintain collaborative arrangements would have a material adverse effect on the Company's business, financial condition and results of operations. See "Management's Discussion and Analysis of Financial Condition and Results of Operations" and "Business -- Collaborative Arrangements." NEED FOR ADDITIONAL FUNDING; UNCERTAIN ACCESS TO CAPITAL The Company's operations to date have consumed substantial capital resources, and LJP will continue to require substantial and increasing amounts of capital to support research, product development, preclinical testing and clinical trials of its drug candidates, to establish commercial-scale manufacturing capabilities, and to market its potential products. The Company's future capital requirements will depend on many factors, including continued scientific progress in its research and development programs, the size and complexity of these programs, the scope and results of preclinical testing and clinical trials, the time and costs involved in applying for regulatory approvals, the costs involved in preparing, filing, prosecuting, maintaining and enforcing patent claims, competing technological and market developments, the ability of the Company to establish and maintain collaborative research and development arrangements and the cost of manufacturing scale-up and effective commercialization activities and arrangements. The Company expects financing provided by Abbott for development, commercialization and marketing of LJP 394 to reduce the Company's rate of consumption of its own funds in the short term. However, Abbott's financing is subject to various conditions and may be unavailable if conditions and milestones are not met or if Abbott decides not to pursue development of LJP 394 after the results of the pending Phase II/III 18 19 clinical trial are reviewed. In addition, initiation and progress of additional drug development programs is expected to result in increased expenditures of the Company's funds. Accordingly, the Company expects to incur significant losses each year for at least the next several years as its clinical trial, research, development and manufacturing scale-up activities increase, and losses may exceed those experienced in prior years if the scope of the Company's programs reaches expected levels, if Abbott does not provide all financing currently anticipated for development of LJP 394, or if the Company is not successful in establishing additional collaborative relationships to help finance other drug discovery programs. The Company expects its existing capital resources, together with anticipated financing from Abbott, to be sufficient to fund the Company's activities, as currently planned, through 1998. However, the amounts expended by the Company for various purposes may vary significantly and Abbott's financial support for development of LJP 394 may terminate under certain circumstances. It is therefore possible that the Company's cash requirements will exceed current projections and that the Company will therefore need additional financing sooner than currently expected. There can be no assurance that the Company will have adequate resources to support its existing or future business activities. The Company actively seeks additional funding, including through collaborative arrangements and public and private financings. The Company's choice of financing alternatives may vary from time to time depending upon various factors, including the market price of the Company's securities, conditions in the financial markets, and the interest of other entities in strategic transactions with the Company. There can be no assurance that additional financing will be available on acceptable terms, if at all, whether through collaborative arrangement, issuance of securities, or otherwise. If adequate funds are not available, the Company may be required to delay, scale back or eliminate one or more of its research and development programs or obtain funds through arrangements with collaborative partners or others that may require the Company to relinquish rights to certain of its technologies or potential products, which could have a material adverse effect on the Company's business, financial condition and results of operations. See "Management's Discussion and Analysis of Financial Condition and Results of Operations." HISTORY OF OPERATING LOSSES; UNCERTAINTY OF FUTURE PROFITABILITY The Company has incurred operating losses each year since its inception in 1989 and had an accumulated deficit of approximately $48.4 million as of December 31, 1996. The continued development of the Company's products will require the commitment of substantial resources to conduct expanded research and preclinical and clinical development programs, to enhance manufacturing capabilities, and to establish additional quality control, regulatory, administrative and marketing and sales capabilities. The Company expects to incur significant losses each year for at least the next several years as its research, development, clinical trial and manufacturing scale-up activities increase, and losses may exceed those experienced in prior years if the scope of the Company's programs reaches expected levels, if Abbott does not provide all financing currently anticipated for development of LJP 394, or if the Company is not successful in establishing additional collaborative relationships to help finance other drug discovery programs. To achieve profitability the Company must, among other things, complete development of its products, obtain regulatory approvals and establish commercial manufacturing and marketing capabilities. The amount of net losses and the time required by the Company to reach sustained profitability are highly uncertain, and the Company does not expect to generate revenues from the sale of products, if any, for at least several years. There can be no assurance that the 19 20 Company will obtain required regulatory approvals, or successfully develop, manufacture, commercialize and market products or that the Company will ever achieve product revenues or profitability. See "Management's Discussion and Analysis of Financial Condition and Results of Operations." GOVERNMENT REGULATION; NO ASSURANCE OF REGULATORY APPROVAL Prior to marketing, any potential product developed by the Company must undergo an extensive regulatory approval process that includes preclinical testing and clinical trials and may include post-marketing surveillance of each compound to establish its safety and efficacy. This regulatory process can take many years and require the expenditure of substantial resources. Data obtained from the Company's preclinical and clinical activities are susceptible to varying interpretations which could delay, limit or prevent regulatory approval. In addition, delays or rejections may be encountered based upon changes in policies of the United States Food and Drug Administration ("FDA") for drug approval during the period of product development and FDA regulatory review of each submitted new drug application ("NDA"). Similar delays may also be encountered in foreign countries. Regulatory approval for a drug may entail limitations on its indicated uses. In addition, the Company will be required to obtain separate regulatory approval for each indicated use of a drug. Even if regulatory approval is obtained, a marketed drug and its manufacturer are subject to continuing review, and discovery of previously unknown problems with a product or manufacturer may have adverse effects on the Company's business, financial condition and results of operations, including withdrawal of the product from the market. Violations of regulatory requirements at any stage, including preclinical testing and clinical trials, the approval process or post-approval surveillance, may result in various adverse consequences including the FDA's delay in approving or its refusal to approve a product, withdrawal of an approved product from the market and the imposition of criminal penalties against the manufacturer and NDA holder. The Company has not submitted any Investigational New Drug ("IND") application for any drug candidate other than LJP 394, and none of the Company's drug candidates has been approved for commercialization in the United States or elsewhere. There can be no assurance that regulatory approval will be obtained for any drugs developed by the Company. Failure to obtain requisite government approvals or approvals of the scope requested would delay or preclude the Company or any licensees or marketing partners from marketing the Company's potential products or limit the commercial use of such products and will have a material adverse effect on the Company's business, financial condition and results of operations. The Company is also subject to numerous and varying foreign regulatory requirements governing the design and conduct of clinical trials and marketing approval for pharmaceutical products to be marketed outside of the United States. The regulatory procedures vary among countries and can involve additional testing, and the time required to obtain approval may differ from that required to obtain FDA approval. The foreign regulatory approval process includes all of the risks associated with obtaining FDA approval, and if approval by the FDA were granted, such approval does not ensure approval by the health authorities of any other country. See "Business -- Government Regulation." PATENTS AND PROPRIETARY TECHNOLOGY The Company's success will depend heavily upon its ability to obtain patent protection for its therapeutic approach and for any developed products, to preserve its trade secrets and to operate without infringing the proprietary rights of third parties. While the Company has received nine United States patents and one Australian patent covering certain aspects of its 20 21 technology, there can be no assurance that any additional patents will be issued, or that the scope of any patent protection will be sufficient, or that any current or future issued patent will be held valid if subsequently challenged. There is a substantial backlog of biotechnology patent applications at the United States Patent and Trademark Office ("USPTO") that may delay the review and issuance of any patents. The patent position of biotechnology firms generally is highly uncertain and involves complex legal and factual questions, and no consistent policy has emerged regarding the breadth of claims covered in biotechnology patents or protection afforded by such patents. To date, the Company has rights to certain United States and foreign issued patents and has filed or participated as a licensee in the filing of a number of patent applications in the United States relating to the Company's technology, as well as foreign counterparts of certain of these applications in certain countries. The Company intends to continue to file applications as appropriate for patents covering both its products and processes. There can be no assurance that patents will issue from any of these applications, or that claims allowed under issued patents will be sufficient to protect the Company's technology. Patent applications in the United States are maintained in secrecy until a patent issues, and the Company cannot be certain that others have not filed patent applications for technology covered by the Company's pending applications or that the Company was the first to invent, or to file patent applications for, such technology. Competitors may have filed applications for, or may have received patents and may obtain additional patents and proprietary rights relating to, compounds or processes that block or compete with those of the Company. A number of pharmaceutical and biotechnology companies and research and academic institutions have filed or may file patent applications, and have received or may receive patents, in the fields being pursued by the Company. Certain of these applications or patents may be competitive with the Company's applications or conflict in certain respects with claims made under the Company's applications. In particular, the Company is aware of one currently pending United States patent application that, if allowed, may contain claims covering subject matter that may be competitive or conflicting with certain of the Company's patents and patent applications. Any conflict between the Company's patents and patent applications, and patents or patent applications of third parties, could result in a significant reduction of the coverage of the Company's existing patents or any future patents that may be issued. In addition, to determine the priority of inventions, the Company may have to participate in interference proceedings declared by the USPTO or in opposition, nullity or other proceedings before foreign agencies with respect to any of its existing patents or patent applications or any future patents or applications, which could result in substantial cost to the Company. Further, the Company may have to participate at substantial cost in International Trade Commission proceedings to abate importation of goods which would compete unfairly with products of the Company. If patents containing competitive or conflicting claims are issued to other parties and such claims are ultimately determined to be valid, there can be no assurance that the Company would be able to obtain licenses to these patents at a reasonable cost, if at all, or be able to develop or obtain alternative technology. The Company also relies upon unpatented trade secrets and improvements, unpatented know-how and continuing technological innovation to develop and maintain its competitive position, which it seeks to protect, in part, by confidentiality agreements with its commercial partners, collaborators, employees and consultants. The Company also has invention or patent assignment agreements with its employees and certain consultants. There can be no assurance that relevant inventions will not be developed by a person not bound by an invention assignment agreement, or that binding agreements will not be breached, that the Company will have 21 22 adequate remedies for any breach, or that the Company's trade secrets will not otherwise become known or be independently discovered by competitors. In addition, the Company could incur substantial costs in defending against suits brought against it by others for infringement of intellectual property rights or in prosecuting suits which the Company might bring against other parties to protect its intellectual property rights. See "Business -- Patents and Proprietary Technologies." COMPETITION AND TECHNOLOGICAL CHANGE The biotechnology and pharmaceutical industries are subject to rapid technological change. Competition from domestic and foreign biotechnology companies, large pharmaceutical companies and other institutions is intense and expected to increase. A number of companies are pursuing the development of pharmaceuticals in the Company's targeted areas. [These include Genelabs Technologies, Inc., which is conducting Phase III clinical trials of a hormone for the treatment of lupus, and other competitors that are working on third-generation steroids.] Many other companies are in earlier stages of developing other potential therapies for lupus. In addition, there are many academic institutions, both public and private, engaged in activities relating to research and development of therapeutics for autoimmune, inflammatory and other diseases. Most of these companies and institutions have substantially greater facilities, resources, research and development capabilities, regulatory compliance expertise, and manufacturing and marketing capabilities than the Company. In addition, other technologies may in the future be the basis of competitive products. There can be no assurance that the Company's competitors will not develop or obtain regulatory approval for products more rapidly than the Company, or develop and market technologies and products that are more effective than those being developed by the Company or that would render the Company's technology and proposed products obsolete or noncompetitive. See "Business -- Competition." LIMITED MANUFACTURING CAPABILITIES The manufacture of the Company's potential products for clinical trials and the manufacture of any approved products for commercial purposes is subject to current Good Manufacturing Practices ("cGMP") as defined by the FDA. While the Company is producing limited quantities of LJP 394 for clinical trials, its current facilities are not adequate for commercial production of its potential products. Pursuant to its agreement with Abbott, the Company is responsible for manufacturing LJP 394 and selling it in bulk form to Abbott for packaging and commercial resale. Substantial capital investment in the expansion and build-out of the Company's manufacturing facilities will be required to enable manufacture of any products in commercial quantities. The Company has never operated an FDA-approved manufacturing facility, and there can be no assurance that it will obtain necessary approvals. The Company has limited manufacturing experience, and no assurance can be given that it will be able to make the transition to commercial production successfully. The Company may enter into arrangements with contract manufacturing companies to expand its own production capacity in order to meet requirements for its products, or to attempt to improve manufacturing efficiency. If the Company chooses to contract for manufacturing services and encounters delays or difficulties in establishing relationships with manufacturers to produce, package and distribute its finished products, clinical trials, market introduction and subsequent sales of such products would be adversely affected. Moreover, contract manufacturers must operate in compliance with the FDA's cGMP requirements. The Company's potential dependence upon third parties for the 22 23 manufacture of its products may adversely affect the Company's profit margins and its ability to develop and deliver such products on a timely and competitive basis. See "Business -- Manufacturing." LACK OF MARKETING EXPERIENCE In order to commercialize any drug candidate approved by the FDA, the Company must either develop a marketing and sales force or enter into marketing arrangements with third parties. Abbott has agreed to be responsible for worldwide marketing of LJP 394, but the Abbott agreement may terminate under certain circumstances, and the Company has no arrangements with third parties for marketing of any of its other drug candidates. There can be no assurance that the Company will be able to enter into any additional marketing agreements on terms favorable to the Company, if at all, or that any such agreements that the Company may enter into will result in payments to the Company. Under the Abbott agreement and any co-promotion or other marketing and sales arrangements that may be entered into with other companies, any revenues to be received by the Company will be dependent on the efforts of others and there can be no assurance that such efforts will be successful. To the extent that the Company chooses to attempt to develop its own marketing and sales capabilities, it will compete with other companies that currently have experienced and well-funded marketing and sales operations. Furthermore, there can be no assurance that the Company or any collaborative partner will be able to establish sales and distribution capabilities without undue delays or expenditures or gain market acceptance for any of the Company's drug candidates. See "Business -- Marketing and Sales." UNCERTAINTIES RELATED TO PHARMACEUTICAL PRICING AND REIMBURSEMENT The continuing efforts of government and third-party payors to contain or reduce the costs of health care through various means may have a material adverse effect on the Company's business, financial condition and results of operations. For example, in certain foreign markets, pricing and/or profitability of prescription pharmaceuticals are subject to government control. In the United States, the Company expects that there will continue to be a number of federal and state proposals to implement similar government control. In addition, increasing emphasis on managed care in the United States will continue to put pressure on pharmaceutical pricing. Cost control initiatives could decrease the price that the Company receives for any products it may develop and sell in the future and have a material adverse effect on the Company's business, financial condition and results of operations. Further, to the extent that cost control initiatives have a material adverse effect on the Company's commercial partners, the Company's ability to commercialize its products may be adversely affected. The Company's ability to commercialize pharmaceutical products may depend in part on the extent to which reimbursement for the products will be available from government health administration authorities, private health insurers and other third-party payors. Significant uncertainty exists as to the reimbursement status of newly approved health care products, and third-party payors, including Medicare, are increasingly challenging the prices charged for medical products and services. There can be no assurance that any third-party insurance coverage will be available to patients for any products developed by the Company. Government and other third-party payors are increasingly attempting to contain health care costs by limiting both coverage and the level of reimbursement for new therapeutic products and by refusing in some cases to provide coverage for uses of approved products for disease indications for which 23 24 the FDA has not granted labeling approval. If adequate coverage and reimbursement levels are not provided by government and other third-party payors for the Company's products, the market acceptance of these products would be adversely affected. POTENTIAL PRODUCT LIABILITY; UNCERTAINTIES RELATED TO INSURANCE The Company has not received marketing approval from the FDA for any of its drug candidates and currently uses LJP 394 only in clinical trials. The use of LJP 394 or any of the Company's other potential products in such clinical trials and the sale of any approved products may expose the Company to liability claims resulting from the use of products or product candidates and associated negative publicity. These claims might be made directly by consumers, pharmaceutical companies or others. The Company maintains product liability insurance coverage for claims arising from the use of its products in clinical trials in the amount of $3.0 million. However, coverage is becoming increasingly expensive, and there can be no assurance that the Company will be able to maintain insurance or, if maintained, that insurance can be acquired at a reasonable cost or in sufficient amounts to protect the Company against losses due to liability that could have a material adverse effect on the Company's business, financial conditions and results of operations. There can be no assurance that the Company will be able to obtain product liability insurance on commercially reasonable terms for any product approved for marketing in the future or that insurance coverage and the resources of the Company would be sufficient to satisfy any liability resulting from product liability claims. A successful product liability claim or series of claims brought against the Company could have a material adverse effect on its business, financial condition and results of operations. DEPENDENCE UPON KEY EMPLOYEES AND CONSULTANTS The Company is highly dependent upon the principal members of its scientific and management staff, the loss of whose services would delay the achievement of its research and development objectives. The Company's anticipated growth and expansion into areas and activities requiring additional expertise, such as clinical trials, government approvals, manufacturing, and marketing, are expected to place increased demands on the Company's resources and require the addition of new management personnel as well as the development of additional expertise by existing management personnel. Retaining the Company's current key employees and recruiting additional qualified scientific personnel to perform research and development work in the future will also be critical to the Company's success. Because competition for experienced scientists among numerous pharmaceutical and biotechnology companies and research and academic institutions is intense, there can be no assurance that the Company will be able to attract and retain such personnel. In addition, the Company relies upon consultants and advisors to assist the Company in formulating its research and development, clinical, regulatory and manufacturing strategies. All of the Company's consultants and advisors are employed outside the Company and may have commitments or consulting or advisory contracts with other entities that may affect their ability to contribute to the Company. ENVIRONMENTAL MATTERS AND HAZARDOUS MATERIALS Due to the nature of its manufacturing processes, the Company is subject to stringent federal, state and local laws, rules, regulations and policies governing the use, generation, 24 25 manufacture, storage, air emission, effluent discharge, handling and disposal of certain materials and wastes. There can be no assurance that the Company will not be required to incur significant costs to comply with environmental regulations as manufacturing is increased to commercial volumes, or that the operations, business or assets of the Company will not be materially and adversely affected by current or future environmental laws, rules, regulations and policies or by any releases or discharges of hazardous material. In its research activities, the Company utilizes radioactive and other materials that could be hazardous to human health, safety or the environment. These materials and various wastes resulting from their use are stored at the Company's facility pending ultimate use and disposal. The risk of accidental injury or contamination from these materials cannot be eliminated. In the event of such an accident, the Company could be held liable for any resulting damages, and any such liability could exceed the Company's resources. VOLATILITY OF COMMON STOCK PRICE The market prices for securities of biotechnology and pharmaceutical companies, including the Company, have historically been highly volatile, and the market has from time to time experienced significant price and volume fluctuations that are unrelated to the operating performance of particular companies. Factors such as fluctuations in the Company's operating results, announcements of technological innovations or new therapeutic products by the Company or others, clinical trial results, developments concerning agreements with collaborators, government regulation, developments in patent or other proprietary rights, public concern as to the safety of drugs discovered or developed by the Company or others, future sales of substantial amounts of Common Stock by existing stockholders, comments by securities analysts and general market conditions can have an adverse effect on the market price of the Common Stock. The realization of any of the risks described in these "Risk Factors" could have an adverse effect on market price of the Company's Common Stock. See "Market for Registrant's Common Equity and Related Stockholder Matters." POTENTIAL ADVERSE EFFECTS OF SHARES ELIGIBLE FOR FUTURE SALE Sales of the Company's Common Stock in the public market, or the perception that such sales could occur, could adversely affect the prevailing market price of the Company's securities and impair the Company's ability to complete equity financings. The Company has outstanding approximately 8,902,000 shares of Common Stock that have been issued in registered public offerings, pursuant to the Company's Employee Stock Purchase Plan or upon exercise of stock options and are freely tradable in the public markets, and approximately 5,310,000 shares of Common Stock currently eligible for resale in the public market pursuant to Rule 144 under the Securities Act of 1933, as amended (the "Securities Act"). An additional 2,000,000 shares issued to an overseas investor pursuant to Regulation S under the Securities Act may also be resold. An additional 1,000,050 shares issued to Abbott may also be resold after a specified period. In addition, an aggregate of 4,170,853 shares of Common Stock are issuable upon exercise of warrants and stock options outstanding as of December 31, 1996, as follows: (i) 1,494,550 shares issuable upon exercise of the Company's publicly traded Redeemable Common Stock Purchase Warrants at an exercise price of $6.00 per share; (ii) 961,219 shares issuable upon exercise of various privately held warrants and options at a weighted average exercise price of $6.54 per share, and (iii) 1,715,084 shares issuable upon exercise of stock options outstanding under the Company's various stock option plans at a 25 26 weighted average exercise price of $3.00 per share. The Company has in effect or intends to file registration statements under the Securities Act registering approximately 2,454,000 shares of Common Stock reserved under its employee stock option and purchase plans, up to 1,494,550 shares of Common Stock reserved for issuance upon exercise of the Company's publicly traded Redeemable Common Stock Purchase Warrants, and resale of approximately 701,219 shares of Common Stock issuable upon exercise of privately held warrants. Approximately 931,465 shares of Common Stock issuable upon future exercise of outstanding stock options will be available for public resale under Rule 144 pursuant to Rule 701 under the Securities Act. The Company is unable to estimate the number of shares of Common Stock that may actually be resold in the public market because this will depend upon the market price for the Common Stock, the individual circumstances of the sellers and other factors. The Company has a number of institutional stockholders that own significant blocks of the Company's Common Stock. If such stockholders sell large portions of their holdings in a relatively short time, for liquidity or other reasons, the prevailing market price of the Company's Common Stock could be negatively affected. ANTI-TAKEOVER PROVISIONS; POSSIBLE ISSUANCES OF PREFERRED STOCK Certain provisions of the Delaware General Corporation Law may have the effect of deterring hostile takeovers or delaying or preventing changes in the control or management of the Company, including transactions in which stockholders might otherwise receive a premium for their shares over then-current market prices. The Company may also issue shares of Preferred Stock without stockholder approval and upon such terms as the Company's Board of Directors may determine. The issuance of Preferred Stock could have the effect of making it more difficult for a third party to acquire a majority of the Company's outstanding stock, and the holders of such Preferred Stock could have voting, dividend, liquidation and other rights superior to those of holders of the Common Stock. ABSENCE OF DIVIDENDS The Company has not paid any cash dividends since its inception and does not anticipate paying any cash dividends in the foreseeable future. ITEM 2. PROPERTIES The Company leases two adjacent buildings in San Diego, California for a total of approximately 54,000 square-feet. Each building is subject to a lease, one that expires in 2001 and one that expires in 2004. Each lease includes an option exercisable by the Company to extend the term of the agreement for an additional five years and are subject to escalation clauses that provide for annual rent increases based on the consumer price index. The Company believes that these facilities will be adequate to meet its needs for the near term. Over the longer term, management believes additional space can be secured at commercially reasonable rates. ITEM 3. LEGAL PROCEEDINGS The Company is not a party to any legal proceedings. 26 27 ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS No matters were submitted to a vote of the Company's security holders during the fourth quarter of the year ended December 31, 1996. EXECUTIVE OFFICERS OF THE REGISTRANT The executive officers and key employees of the Company and their ages are set forth below. Steven B. Engle 42 Chairman of the Board, Chief Executive Officer, and Assistant Secretary Stephen M. Coutts, Ph.D. 56 Executive Vice President of Research and Development Peter G. Ulrich 44 Senior Vice President of Corporate Development and Marketing Bonnie Hepburn, M.D. 56 Vice President of Clinical Development Mark T. Edgar, Ph.D. 46 Vice President of Operations Wood C. Erwin, CPA 46 Vice President of Finance, Chief Financial Officer and Secretary Andrew Wiseman, Ph.D. 48 Director of Business Development
STEVEN B. ENGLE, Chairman of the Board and Chief Executive Officer, joined the Company as Executive Vice President and Chief Operating Officer in 1993, became President and a Director in 1994, Chief Executive Officer in 1995 and Chairman of the Board in 1997. From 1991 to 1993, Mr. Engle served as Vice President of Marketing, Acting Vice President of Manufacturing and Acting Chief Executive Officer for Cygnus Inc., a publicly held company that develops drug delivery systems. From 1987 to 1991, he was Chief Executive Officer of Quantum Management Company, a management consulting firm serving the pharmaceutical and biotechnology industry. From 1984 to 1987, he was Vice President of Marketing and Divisional General Manager for Micro Power Systems Inc., a privately held company that manufactures high technology products including medical devices. He holds an MSEE and a BSEE in Biomedical Engineering from the University of Texas. STEPHEN M. COUTTS, Ph.D., has served as the Executive Vice President of Research and Development of the Company since its formation in May 1989. From 1987 until 1989, Dr. Coutts was Vice President of Therapeutics Research & Development for Quidel Corporation, a publicly held company that markets human diagnostic kits. From 1986 to 1987 he served as Executive Director of Scientific Research of the Purdue Frederick Company, a pharmaceutical company, and from 1976 to 1986 he held various positions with the Revlon Health Care Group, including Director of Revlon's Department of Immunobiology. From 1968 to 1976, Dr. Coutts 27 28 held academic research and teaching positions at The Institute for Molecular Biology (Braunschweig, Germany) and Princeton University. Dr. Coutts holds an MBA from New York University and a Ph.D. in Biochemistry from Harvard University. PETER G. ULRICH joined the Company in December 1995 as Senior Vice President of Corporate Development and Marketing. Mr. Ulrich has served as President and Chief Executive Officer of three biotechnology companies: MedClone, Inc., a biotechnology company developing therapuetics for autoimmune diseases from 1991 to 1994, LipoGen, Inc. from 1988 to 1990, and BIOTX from 1985 to 1988. From 1982 to 1985, he was the Vice President of Marketing at Analytical Luminescence Laboratory, and from 1974 to 1982 he held various positions with Baxter Travenol Laboratories, including International Marketing Manager and National Sales Manager. Before joining the Company, Mr. Ulrich served for one year as Assistant Vice President of Technology Development for the University of Alabama at Birmingham. Mr. Ulrich holds a B.A. from the University of Texas at Austin and a Masters Degree in International Business Administration from the University of Dallas. BONNIE HEPBURN, M.D, a practicing rheumatologist, joined the Company in April 1996 as Vice President of Clinical Development. Prior to joining the Company, from 1994 to 1995, Dr. Hepburn served as Director of Immunology Clinical Research for Centocor. From 1987 to 1994, Dr. Hepburn held several positions with Ciba-Geigy Ltd., including Head of Inflammation/Bone/Allergy Clinical Research, Executive Director of Anti-Inflammatory/Pulmonary Clinical Research, and Director of Regulatory Affairs. She served as a member and chairman on the FDA Arthritis Advisory Committee from 1980 to 1983 and also on the Committee for Revision of FDA Antirheumatic Drug Guidelines. Since 1975, Dr. Hepburn has held a faculty position at UMDNJ-Robert Wood Johnson Medical School (formerly Rutgers Medical School). Dr. Hepburn received her B.A. from Wellesley College and her M.D. from the University of Pennsylvania School of Medicine, and completed her medical residency and fellowship in rheumatology at the Mayo Clinic. MARK T. EDGAR, Ph.D. Vice President of Operations, joined the Company in May 1995 as Vice President of Manufacturing. Prior to joining the Company, Dr. Edgar was with Syntex Corp. for 15 years, during which time he served in a variety of capacities, including as Vice President and Director of the CNTF Program Management Team at Syntex Development Research from 1993 to 1995; Director of Operations at Syntex Bahamas Chemical from 1990 to 1993; and Director of Manufacturing Engineering and Materials at Syntex Laboratories, Inc. from 1987 to 1990. Dr. Edgar holds a Ph.D. in organic chemistry from Arizona State University and an MBA from the University of Colorado. WOOD C. ERWIN joined the Company as Vice President of Finance and Chief Financial Officer in January 1996. Before joining the Company, Mr. Erwin served during 1995 as Vice President of Finance and Chief Financial Officer of Resource Optimization, Inc., a software company. From 1992 to 1995 he served as Chief Financial Officer of MedClone, Inc., a biotechnology company developing therapeutics for autoimmune diseases. From 1991 to 1992, Mr. Erwin served as Vice President of Finance and Chief Financial Officer of Med Images, Inc., a provider of computerized services to hospitals; and from 1986 to 1991 as Chief Financial Officer and Director of Operations of LipoGen, Inc., a biotechnology company. Mr. Erwin was also the Controller of Plasti-Line, Inc., a publicly traded manufacturer of illuminated signs; Vice President of Finance of Kusan, Inc., a subsidiary of Bethlehem Steel Corp.; and Cost 28 29 Analyst for Oscar Meyer Company. Mr. Erwin holds BS and MBA degrees from the University of Tennessee and is a Certified Public Accountant and Certified Management Accountant. ANDREW WISEMAN, Ph.D., has served as the Director of Business Development for the Company since its formation in May 1989. From 1983 to 1989, Dr. Wiseman held several positions with Quidel Corporation, including Senior Research Scientist, Project Manager in Diagnostic Research and Development and Manager of Business Development. Dr. Wiseman was an Associate Member (Professor) at the Medical Biology Institute and an Assistant Member at the Scripps Clinic and Research Foundation and holds a Ph.D. in Genetics from Duke University. 29 30 PART II ITEM 5. MARKET FOR REGISTRANT'S COMMON EQUITY AND RELATED STOCKHOLDER MATTERS. The Company's Common Stock trades on the Nasdaq National Market under the symbol "LJPC". Set forth below are the high and low sales prices for the Company's Common Stock for each full quarterly period within the two most recent fiscal years.
High Low ---- --- Year Ended December 31, 1996 First Quarter 9-3/8 4-7/8 Second Quarter 8-7/8 5-1/8 Third Quarter 6-7/16 3-7/8 Fourth Quarter 6-5/16 3-1/2 Year Ended December 31, 1995 First Quarter 3-5/8 1-3/4 Second Quarter 4 2-3/4 Third Quarter 5-5/8 3-11/16 Fourth Quarter 5 3-3/4
The Company has not paid dividends on its Common Stock and does not anticipate paying dividends in the foreseeable future. The approximate number of holders of record the Company's Common Stock as of March 17, 1997, was 288. In December 1996, the Company sold 1,000,050 shares of its Common Stock to Abbott for an aggregate price of $4.0 million. The sale was a privately negotiated sale to a single buyer and was exempt from registration under Section 4(2) of the Securities Act of 1933, as amended, and there were no underwriters involved. 30 31 ITEM 6. SELECTED FINANCIAL DATA. The following Selected Financial Data should be read in conjunction with "Management's Discussion and Analysis of Financial Condition and Results of Operations" included in Item 7 below and the financial statements of the Company and related notes thereto beginning at page F-1 of this Report.
Years Ended December 31, ------------------------ 1992 1993 1994 1995 1996 ---- ---- ---- ---- ---- (In thousands, except per share data) STATEMENT OF OPERATIONS DATA: Revenue from collaborative agreements $ - $ - $ - $ 3,000 $ 4,000 Expenses: Research and development 4,425 6,737 8,499 9,804 11,663 General and administrative 1,052 1,386 2,049 2,390 2,920 -------- -------- -------- -------- -------- Loss from operations (5,477) (8,123) (10,548) (9,194) (10,583) Interest expense -- (145) (364) (301) (183) Interest income 705 321 599 941 1,170 -------- -------- -------- -------- -------- Net loss $ (4,772) $ (7,947) $(10,313) $ (8,554) $ (9,596) ======== ======== ======== ======== ======== Net loss per share $ (.96) $ (1.58) $ (1.44) $ (.79) $ (.63) ======== ======== ======== ======== ======== Shares used in computing net loss per share (1) 4,949 5,016 7,137 10,883 15,150 ======== ======== ======== ======== ======== BALANCE SHEET DATA: Working capital $ 13,237 $ 6,314 $ 12,643 $ 21,949 $ 25,886 Total assets $ 15,269 $ 10,102 $ 17,094 $ 26,375 $ 31,687 Noncurrent portion of obligations under capital leases $ -- $ 1,595 $ 1,628 $ 892 $ 168 Stockholders' equity $ 14,855 $ 6,938 $ 13,810 $ 23,568 $ 27,938
(1) See Note 1 of Notes to Financial Statements for an explanation of the computation of per share data. 31 32 ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS. Since its inception in May 1989, the Company has devoted substantially all of its resources to the research and development of technology and potential drugs to treat antibody-mediated diseases. The Company has never generated any revenue from product sales and has relied upon private and public investors, equipment lease financings, revenues from collaborative agreements, and interest income on invested cash balances for its working capital. The Company has been unprofitable since inception and expects to incur substantial additional operating losses for at least the next several years as it increases expenditures on research and development and allocates significant and increasing resources to its clinical trials, manufacturing and marketing activities. The Company's activities to date are not as broad in depth or scope as the activities it must undertake in the future, and the Company's historical operations and the financial information included in this Report are not indicative of its future operating results or financial condition. The Company expects that losses will fluctuate from quarter to quarter as a result of differences in the timing of expenses incurred and potential revenues from collaborative arrangements. Some of these fluctuations may be significant. The Company's research and development expenses are expected to increase significantly in the future as the Company increases its development efforts. As of December 31, 1996, the Company's accumulated deficit was approximately $48.4 million. The Company's business is subject to significant risks including, but not limited to, the risks inherent in its research and development efforts, including clinical trials, uncertainties associated with both obtaining and enforcing its patents and with the patent rights of others, the lengthy, expensive and uncertain process of seeking regulatory approvals, uncertainties regarding government reforms and of product pricing and reimbursement levels, technological change and competition, manufacturing uncertainties and dependence on its collaborative relationship with Abbott. Even if the Company's product candidates appear promising at an early stage of development, they may not reach the market for numerous reasons. Such reasons include the possibilities that the products will be ineffective or unsafe during clinical trials, will fail to receive necessary regulatory approvals, will be difficult to manufacture on a large scale, will be uneconomical to market or will be precluded from commercialization by proprietary rights of third parties. RESULTS OF OPERATIONS YEARS ENDED DECEMBER 31, 1996, 1995, AND 1994 Revenue. The Company had revenue of $4.0 million and $3.0 million in the years ended December 31, 1996 and 1995, respectively, and no revenue in the year ended December 31, 1994 (or at any other time since inception). In December 1996 the Company entered into a collaborative agreement with Abbott for the worldwide development and commercialization of LJP 394, the Company's lupus drug candidate. Revenue in 1996 is attributable solely to an up front license fee upon the signing of its collaborative agreement with Abbott. Revenue in 1995 was attributable solely to a one-time initial license fee under a prior collaborative agreement which was terminated in May 1996. The collaborative agreement with Abbott obligates Abbott to make further development funding and milestone payments, but both Abbott and the Company 32 33 have the right to terminate the agreement under certain circumstances. Accordingly, there is no assurance that the Company will realize any further revenue from this arrangement or any other collaborative arrangement. Research and Development Expenses. The Company's research and development expenses increased to $11.7 million for the year ended December 31, 1996 from $9.8 million in 1995 and $8.5 million in 1994. Several factors contributed to this increase, including additions to research and development personnel, expansion of the Company's research and development programs, manufacturing scale-up activities, conduct of the Company's toxicology and clinical programs including Phase II/III clinical trials of LJP 394, and increased facilities expenditures. The Company's research and development expenses are expected to increase significantly in the future as the organization grows, efforts to develop additional drug candidates are intensified and potential products progress into and through clinical trials. General and Administrative Expenses. The Company's general and administrative expenses increased to $2.9 million for the year ended December 31, 1996 from $2.4 million in 1995 and $2.0 million in 1994. Several factors contributed to this increase, including increased personnel to support increased research and development and clinical activities, increased facilities expenditures and expanded business development activities. The Company expects general and administrative expenses to increase at a greater rate in the future because, among other reasons, the Company has leased additional space to house expanded research and development and manufacturing activities. Interest Income and Expense. The Company's interest income increased to $1.2 million for the year ended December 31, 1996 from $941,000 in 1995 and $599,000 in 1994. The increase in interest income in 1996 as compared to 1995 was due to the investment of the proceeds from the Company's additional public offering in July and August 1996. The increase in interest income in 1995 as compared to 1994 was due to the investment of the proceeds from the Company's public offering in June 1995, its sale of stock to a private investor in October 1995, and an initial payment from a former collaborative agreement in September 1995. Interest expense decreased to $183,000 for the year ended December 31, 1996 from $301,000 in 1995 and $364,000 in 1994. The decrease in interest expense was the result of decreases in the Company's capital lease obligations. Net Operating Loss Carryforwards. At December 31, 1996, the Company had available net operating loss carryforwards and research credit carryforwards of approximately $45.0 million and $2.3 million, respectively, for federal income tax purposes, which will begin to expire in 2004 unless previously utilized. Because of "change in ownership" provisions of the Tax Reform Act of 1986, the Company's net operating loss and tax credit carryforwards will be subject to an annual limitation regarding utilization against taxable income in future periods. The Company believes that such limitation will not have a material impact on the benefits that may arise out of its net operating loss and tax credit carryforwards, but there can be no assurance that additional limitations arising from any future changes in ownership will not have a material impact on the Company. For more information concerning the provision for income taxes, see Note 7 of the Notes to Financial Statements. 33 34 LIQUIDITY AND CAPITAL RESOURCES From inception through December 31, 1996, the Company had incurred a cumulative net loss of approximately $48.4 million, and financed its operations through private and public offerings of its securities, capital and operating lease transactions, the payment from its previous collaborative partner, and interest income on its invested cash balances. As of December 31, 1996, the Company had raised $75.6 million in net proceeds since inception from sales of equity securities. At December 31, 1996, the Company had $24.2 million in cash, cash equivalents and short-term investments, as compared to $23.7 million at December 31, 1995. The Company's working capital at December 31, 1996 was $25.9 million, as compared to $21.9 million at December 31, 1995. The increases in cash, cash equivalents and short-term investments and in working capital resulted from the completion of its follow-on public offering in July and August 1996 and its sale of stock to Abbott in December 1996, partially offset by the continued use of the Company's cash toward expenses of ongoing research and development and clinical programs and related general and administrative expenses. The Company invests its cash in corporate and U.S. Government backed debt instruments. As of December 31, 1996, the Company had acquired an aggregate of $4.5 million in property and equipment, of which approximately $3.2 million had been acquired through capital lease obligations. In addition, the Company leases its office and laboratory facilities and certain equipment under operating leases. The Company has no material commitments for the acquisition of property and equipment but anticipates increasing investment in property and equipment in connection with the enhancement of its manufacturing capabilities. The Company intends to use its financial resources to fund clinical trials, research and development, manufacturing scale-up, and for working capital and other general corporate purposes. Anticipated near-term expenses include costs of additional clinical trials for LJP 394, the production of LJP 394 for clinical and toxicology studies, and the expansion of manufacturing and research activities. The amounts actually expended for each purpose may vary significantly depending upon numerous factors, including the results of clinical studies, the timing of regulatory applications and approvals, and technological advances. Expenditures will also depend upon the establishment and progress of collaborative arrangements, contract research and the availability of other financings. There can be no assurance that these funds will be available on acceptable terms, if at all. The Company anticipates that its existing capital and interest earned thereon will be sufficient to fund the Company's operations as currently planned through 1998. The Company's future capital requirements will depend on many factors, including continued scientific progress in its research and development programs, the size and complexity of these programs, the scope and results of clinical trials, the time and costs involved in applying for regulatory approvals, the costs involved in preparing, filing, prosecuting, maintaining and enforcing patent claims, competing technological and market developments, the ability of the Company to maintain its collaborative arrangement with Abbott and to establish and maintain additional collaborative relationships and the cost of manufacturing scale-up and effective commercialization activities and arrangements. The Company expects to incur significant losses each year for at least the 34 35 next several years as it expands its current research and development programs and invests increasing amounts of capital in clinical trials, manufacturing scale-up, and administration of a more complex organization. It is possible that the Company's cash requirements will exceed current projections and that the Company will therefore need additional financing sooner than currently expected. The Company has no current means of generating cash flow from operations, and its lead drug candidate, LJP 394, will not generate revenues, if at all, until it has been proven safe and effective, has received regulatory approval, and has been successfully commercialized, a process that is expected to take at least the next several years. The Company's other drug candidates are much less developed than LJP 394. There can be no assurance that the Company's product development efforts with respect to LJP 394 or any other drug candidate will be successfully completed, that required regulatory approvals will be obtained, or that any product, if introduced, will be successfully marketed or achieve commercial acceptance. Accordingly, the Company must continue to rely upon outside sources of financing to meet its capital needs for the foreseeable future. Abbott's funding of the development costs for LJP 394 and milestone payments are expected to enhance the Company's short-term liquidity by minimizing the expenditure of the Company's own funds on further development of LJP 394. However, the Company anticipates increasing expenditures on manufacturing activities and the development of other drug candidates, and in the long run, the Company's consumption of cash will necessitate additional sources of financing. Furthermore, the Company has no internal sources of liquidity, and termination of the Abbott arrangement would have a serious adverse effect on the Company's ability to generate sufficient cash to meet its needs. The Company will continue to seek capital through any appropriate means, including issuance of its securities and establishment of additional collaborative arrangements. However, there can be no assurance that additional financing will be available on acceptable terms, and the Company's negotiating position in its capital-raising efforts may worsen as it continues to use its existing resources. Financing through collaborative arrangements is uncertain because payments under the Company's collaborative agreement with Abbott are subject to certain termination rights, including related to progress in clinical trials for LJP 394, and there is no assurance that the Company will be able to enter into further collaborative relationships. ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA. The financial statements and supplementary data required by this item are at the end of this Report beginning on page F-1. ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE. None. 35 36 PART III ITEM 10. DIRECTORS AND EXECUTIVE OFFICERS OF THE REGISTRANT. Information concerning the Company's executive officers is included under the caption "Executive Officers" following Part I, Item 4 of this Report. Other information for Item 10 is incorporated by reference from the portions of the Registrant's definitive proxy statement for its annual meeting of stockholders to be held on May 13, 1997 entitled "Proposal 1 - Election of Directors" and "Section 16(a) Beneficial Ownership Reporting Compliance". ITEM 11. EXECUTIVE COMPENSATION. Information for Item 11 is incorporated by reference from the portions of the Registrant's definitive proxy statement for its annual meeting of stockholders to be held on May 13, 1997 entitled "Executive Compensation and Other Information," "Report of the Compensation Committee on Executive Compensation," "Compensation Committee Interlocks and Insider Participation," and "Stock Performance Graph." ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT. Information for Item 12 is incorporated by reference from the portion of the Registrant's definitive proxy statement for its annual meeting of stockholders to be held on May 13, 1997 entitled "Security Ownership of Certain Beneficial Owners and Management." ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS. No disclosures are required. 36 37 PART IV ITEM 14. EXHIBITS, FINANCIAL STATEMENT SCHEDULES, AND REPORTS ON FORM 8-K. (a) Documents filed as part of this Report: 1. Financial Statements. The following financial statements of La Jolla Pharmaceutical Company are included in Item 8: Report of Ernst & Young LLP, Independent Auditors................................................ F-1 Balance Sheets at December 31, 1996 and 1995.....................................................F-2 Statements of Operations for the fiscal years ended December 31, 1996, 1995 and 1994.........................F-3 Statements of Stockholders' Equity for the fiscal years ended December 31, 1996, 1995 and 1994...................F-4 Statements of Cash Flows for the fiscal years ended December 31, 1996, 1995 and 1994.........................F-5 Notes to Financial Statements............................F-6 2. Financial Statement Schedules. No financial statement schedules are required. 37 38 3. Exhibits. Exhibit Number Description - ------ ----------- 3.1 Intentionally omitted 3.2 Bylaws of the Company (1) 3.3 Restated Certificate of Incorporation of the Company (3) 10.1 Intentionally omitted 10.2 Stock Option Agreement dated February 4, 1993 entitling Joseph Stemler to purchase 35,000 shares of Common Stock (1) * 10.3 Letter regarding terms of employment and potential severance of Stephen M. Coutts (1) * 10.4 Intentionally omitted 10.5 Intentionally omitted 10.6 Steven B. Engle Employment Agreement (1) * 10.7 Form of Directors and Officers Indemnification Agreement (1) 10.8 Intentionally omitted 10.9 Exclusive License Agreement dated September 1, 1991 regarding PLA2 inhibition technology between the Company and the Regents of the University of California (1) 10.10 Option and Collaborative Research Agreement dated June 10, 1991 regarding certain compounds for potential treatment of muscular dystrophies or myasthenia gravis between the Company and CepTor Corporation (1) 10.11 Consulting Agreement dated September 1, 1991 between the Company and Dr. Edward A. Dennis (1) 10.12 Agreement dated September 1, 1991 regarding stock purchase between the Company and Dr. Edward A. Dennis (1) 10.13 Form of Employee Invention and Confidential Information Agreement (1) 10.14 Industrial Real Estate Lease (1) 10.15 Intentionally omitted 10.16 Master Lease Agreement dated June 22, 1993 with Aberlyn Capital Management Limited Partnership ("ACM") and related Agreements to Issue Warrant with Warrants issued to ACM and Aberlyn Holding Company, Inc. (1) 10.17 La Jolla Pharmaceutical Company 1989 Incentive Stock Option Plan and 1989 Nonstatutory Stock Option Plan (1) * 10.18 Form of Stock Option Agreement under the 1989 Nonstatutory Stock Option Plan (1) 10.19 La Jolla Pharmaceutical Company 1994 Incentive Stock Option Plan (1) * 10.20 Intentionally omitted 10.21 Letter Agreement dated June 7, 1993 between the Company and Vector Securities International regarding Vector's engagement as financial advisor to the Company with respect to potential corporate strategic alliances (1) 38 39 10.22 Letter Agreement dated December 23, 1993 between the Company and Aberlyn Holding Company, Inc. regarding Aberlyn's engagement as financial and investment banking advisor to the Company with respect to potential strategic alliances with Korean pharmaceutical companies (1) 10.23 Intentionally omitted 10.24 Intentionally omitted 10.25 Second Amendment to Lease dated June 30, 1994 by and between the Company and BRE Properties, Inc. (2) 10.26 Intentionally omitted 10.27 Third Amendment to Lease dated January 26, 1995 by and between the Company and BRE Properties, Inc. (4) 10.28 Intentionally omitted 10.29 Master Lease Agreement dated September 13, 1995 by and between the Company and Comdisco Electronics Group (5) 10.30 Intentionally omitted 10.31 Agreement dated September 22, 1995 between the Company and Joseph Stemler regarding option vesting *(6) 10.32 Consulting Agreement dated January 1, 1996 between the Company and Joseph Stemler*(6) 10.33 Building Lease Agreement effective November 1, 1996 by and between the Company and WCB II-S BRD Limited Partnership (7) 10.34 Master Lease Agreement dated December 20, 1996 by and between the Company and Transamerica Business Credit Corporation 10.35 License and Supply Agreement dated December 23, 1996 by and between the Company and Abbott Laboratories (8) 10.36 Stock Purchase Agreement dated December 23, 1996 by and between the Company and Abbott Laboratories 23.1 Consent of Ernst & Young LLP, Independent Auditors 27 Financial Data Schedule __________________ * This exhibit is a management contract or compensatory plan or arrangement. (1) Previously filed with the Company's Registration Statement on Form S-1 (No. 33-76480) as declared effective by the Securities and Exchange Commission on June 3, 1994. (2) Previously filed with the Company's quarterly report on Form 10-Q for the quarter ended June 30, 1994 and incorporated by reference herein. (3) Previously filed with the Company's annual report on Form 10-K for the fiscal year ended December 31, 1994 and incorporated by reference herein. (4) Previously filed with the Company's quarterly report on Form 10-Q for the quarter ended March 31, 1995 and incorporated by reference herein. (5) Previously filed with the Company's quarterly report on Form 10-Q for the quarter ended September 30, 1995 and incorporated by reference herein. (6) Previously filed with the Company's annual report on Form 10-K for the fiscal year ended December 31, 1995 and incorporated by reference herein. 39 40 (7) Previously filed with the Company's quarterly report on Form 10-Q for the quarter ended September 30, 1996 and incorporated by reference herein. (8) Portions of the Exhibit 10.35 have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934. (b) Reports on Form 8-K: The Company did not file any reports on Form 8-K during the three months ended December 31, 1996. 40 41 Report of Ernst & Young LLP, Independent Auditors The Board of Directors and Stockholders La Jolla Pharmaceutical Company We have audited the accompanying balance sheets of La Jolla Pharmaceutical Company as of December 31, 1996 and 1995, and the related statements of operations, stockholders' equity and cash flows for each of the three years in the period ended December 31, 1996. These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on these financial statements based on our audits. We conducted our audits in accordance with generally accepted auditing standards. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion. In our opinion, the financial statements referred to above present fairly, in all material respects, the financial position of La Jolla Pharmaceutical Company at December 31, 1996 and 1995, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 1996, in conformity with generally accepted accounting principles. ERNST & YOUNG LLP San Diego, California January 30, 1997 F-1 42 La Jolla Pharmaceutical Company Balance Sheets (In thousands, except share and per share data)
DECEMBER 31, 1996 1995 ---------------------------- ASSETS Current assets: Cash and cash equivalents $ 6,613 $ 19,804 Short-term investments 17,621 3,847 Receivable 4,000 -- Other current assets 1,233 213 ---------------------------- Total current assets 29,467 23,864 Property and equipment, net 1,361 1,925 Patent costs and other assets, net 859 586 ---------------------------- $ 31,687 $ 26,375 ============================ LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $ 1,539 $ 333 Accrued expenses 1,106 493 Accrued payroll and related expenses 294 310 Current portion of obligations under capital leases 642 779 ---------------------------- Total current liabilities 3,581 1,915 Noncurrent portion of obligations under capital leases 168 892 Commitments Stockholders' equity: Common stock, $.01 par value; 32,000,000 shares authorized, 17,279,195 and 14,046,712 shares issued and outstanding at December 31, 1996 and 1995, respectively 173 140 Additional paid-in capital 76,307 62,647 Note receivable from stockholder -- (14) Deferred compensation (169) (428) Accumulated deficit (48,373) (38,777) ---------------------------- Total stockholders' equity 27,938 23,568 ---------------------------- $ 31,687 $ 26,375 ============================
See accompanying notes. F-2 43 La Jolla Pharmaceutical Company Statements of Operations (In thousands, except per share data)
YEARS ENDED DECEMBER 31, 1996 1995 1994 ------------------------------------------------------ Revenue from collaborative agreements $ 4,000 $ 3,000 $ - Expenses: Research and development 11,663 9,804 8,499 General and administrative 2,920 2,390 2,049 ------------------------------------------------------ Total expenses 14,583 12,194 10,548 ------------------------------------------------------ Loss from operations (10,583) (9,194) (10,548) Interest expense (183) (301) (364) Interest income 1,170 941 599 ------------------------------------------------------ Net loss $ (9,596) $ (8,554) $ (10,313) ====================================================== Net loss per share $ (.63) $ (.79) $ (1.44) ====================================================== Shares used in computing net loss per share 15,150 10,883 7,137 ======================================================
See accompanying notes. F-3 44 La Jolla Pharmaceutical Company Statements of Stockholders' Equity For the years ended December 31, 1994, 1995 and 1996 (In thousands)
CONVERTIBLE PREFERRED STOCK COMMON STOCK ADDITIONAL ----------------------------------------------------- PAID-IN SHARES AMOUNT SHARES AMOUNT CAPITAL ------------------------------------------------------------------- Balance at December 31, 1993 39,411 $ 394 787 $ 8 $ 26,784 Issuance of common stock upon initial public offering, net of issuance costs - - 2,990 30 12,672 Conversion of preferred stock to common stock (39,411) (394) 3,941 39 355 Conversion of bridge notes and accrued interest to common stock - - 833 8 4,159 Exercise of stock options - - 65 1 64 Payment on note receivable - - - - - Deferred compensation related to grant of stock options - - - - 656 Amortization of deferred compensation - - - - - Net loss - - - - - ------------------------------------------------------------------- Balance at December 31, 1994 - - 8,616 86 44,690 Issuance of common stock upon secondary public offering, net of issuance costs - - 3,400 34 9,852 Issuance of common stock - - 2,000 20 8,120 Exercise of stock options - - 31 - 30 Payment on note receivable - - - - - Amortization of deferred compensation - - - - - Adjustment to deferred compensation for terminations - - - - (45) Net loss - - - - - ------------------------------------------------------------------- Balance at December 31, 1995 - - 14,047 140 62,647 Issuance of common stock upon additional public offering, net of issuance costs - - 2,140 21 9,753 Issuance of common stock - - 1,000 10 3,790 Issuance of common stock under Employee Stock Purchase Plan - - 27 1 97 Exercise of stock options and warrants - - 65 1 85 Payment on note receivable - - - - - Amortization of deferred compensation - - - - - Adjustment to deferred compensation for terminations - - - - (65) Net loss - - - - - ==================================================== ============== Balance at December 31, 1996 - $ - 17,279 $ 173 $ 76,307 ==================================================== ==============
NOTE RECEIVABLE TOTAL FROM DEFERRED ACCUMULATED STOCKHOLDERS' STOCKHOLDER COMPENSATION DEFICIT EQUITY ------------------------------------------------------------------- Balance at December 31, 1993 $ (39) $ (299) $ (19,910) $ 6,938 Issuance of common stock upon initial public offering, net of issuance costs - - - 12,702 Conversion of preferred stock to common stock - - - - Conversion of bridge notes and accrued interest to common stock - - - 4,167 Exercise of stock options - - - 65 Payment on note receivable 12 - - 12 Deferred compensation related to grant of stock options - (656) - - Amortization of deferred compensation - 239 - 239 Net loss - - (10,313) (10,313) ------------------------------------------------------------------- Balance at December 31, 1994 (27) (716) (30,223) 13,810 Issuance of common stock upon secondary public offering, net of issuance costs - - - 9,886 Issuance of common stock - - - 8,140 Exercise of stock options - - - 30 Payment on note receivable 13 - - 13 Amortization of deferred compensation - 243 - 243 Adjustment to deferred compensation for terminations - 45 - - Net loss - - (8,554) (8,554) ------------------------------------------------------------------- Balance at December 31, 1995 (14) (428) (38,777) 23,568 Issuance of common stock upon additional public offering, net of issuance costs - - - 9,774 Issuance of common stock - - - 3,800 Issuance of common stock under Employee Stock Purchase Plan - - - 98 Exercise of stock options and warrants - - - 86 Payment on note receivable 14 - - 14 Amortization of deferred compensation - 194 - 194 Adjustment to deferred compensation for terminations - 65 - - Net loss - - (9,596) (9,596) =================================================================== Balance at December 31, 1996 $ - $ (169) $ (48,373) $ 27,938 ===================================================================
See accompanying notes. F-4 45 La Jolla Pharmaceutical Company Statements of Cash Flows (In thousands)
YEARS ENDED DECEMBER 31, 1996 1995 1994 ---------------------------------------------- OPERATING ACTIVITIES Net loss $ (9,596) $ (8,554) $ (10,313) Adjustments to reconcile net loss to net cash used for operating activities: Write-off of patent costs 89 - - Depreciation and amortization 754 784 683 Deferred compensation amortization 194 243 239 Common stock issued for interest - - 11 Changes in operating assets and liabilities: Receivable (4,000) - - Other current assets (1,020) 89 (148) Accounts payable and accrued expenses 1,819 3 (147) Accrued payroll and related expenses (16) 145 28 ---------------------------------------------- Net cash used for operating activities (11,776) (7,290) (9,647) INVESTING ACTIVITIES Increase in short-term investments (13,774) (1,304) (2,543) Additions to property and equipment (161) (248) (288) Increase in patent costs and other assets (391) (83) (120) ---------------------------------------------- Net cash used for investing activities (14,326) (1,635) (2,951) FINANCING ACTIVITIES Payment on note receivable from stockholder 14 13 12 Net proceeds from issuance of common stock 13,758 18,056 12,767 Proceeds from bridge notes - - 4,156 Payments on obligations under capital leases (861) (757) (619) ---------------------------------------------- Net cash provided by financing activities 12,911 17,312 16,316 ---------------------------------------------- (Decrease) increase in cash and cash equivalents (13,191) 8,387 3,718 Cash and cash equivalents at beginning of period 19,804 11,417 7,699 ---------------------------------------------- Cash and cash equivalents at end of period $ 6,613 $ 19,804 $ 11,417 ============================================== SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION: Interest paid $ 183 $ 301 $ 353 ============================================== SUPPLEMENTAL SCHEDULE OF NONCASH FINANCING ACTIVITIES: Capital lease obligations incurred for property and equipment $ -- $ 132 $ 858 ============================================== Adjustment to deferred compensation for terminations $ 65 $ 45 $ -- ==============================================
See accompanying notes. F-5 46 La Jolla Pharmaceutical Company Notes to Financial Statements 1. ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES ORGANIZATION AND BUSINESS ACTIVITY La Jolla Pharmaceutical Company (the "Company") is a biopharmaceutical company focused on the research and development of highly specific therapeutics for the treatment of certain life-threatening antibody-mediated diseases. These diseases, including autoimmune conditions such as systemic lupus erythematosus ("lupus") and antibody-mediated stroke, are caused by abnormal B cell production of antibodies that attack healthy tissues. In the fourth quarter of 1996, the Company initiated a Phase II/III clinical trial for its lupus drug candidate, LJP 394. The Company was classified as a development stage company through the fourth quarter of 1996. All of the Company's revenues to date have been derived from its recent collaborative agreement with Abbott Laboratories ("Abbott") in December 1996 and its former collaborative agreement with Leo Pharmaceutical Products Ltd., a Danish company ("Leo Pharmaceutical"). (See Note 2.) As part of its planned business operations, the Company pursues collaborations with pharmaceutical companies in an effort to access their research, drug development, manufacturing and financial resources. Prior to generating product revenues, the Company must complete the development of its products, including several years of clinical testing, and receive regulatory approvals prior to selling these products commercially. There can be no assurance that the Company's product development efforts with respect to LJP 394 or any other drug candidate will be successfully completed, that required regulatory approvals will be obtained, or that any product, if introduced, will be successfully marketed or achieve commercial acceptance. In addition, there can be no assurance that the Company can successfully manufacture and market any such products at prices that would permit the Company to operate profitably. The Company actively seeks additional financing to fund its research and development efforts and commercialize its technologies. There is no assurance such financing will be available to the Company when required or that such financing would be available under favorable terms. The Company believes that patents and other proprietary rights are important to its business. The Company's policy is to file patent applications to protect technology, inventions and improvements to its inventions that are considered important to the development of its business. The patent positions of biotechnology firms, including the Company, are uncertain and involve complex legal and factual questions for which important legal principles are largely unresolved. There can be no assurance that any additional patents will be issued, or that the scope of any patent protection will be sufficient, or that any current or future issued patent will be held valid if subsequently challenged. F-6 47 La Jolla Pharmaceutical Company Notes to Financial Statements 1. ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (CONTINUED) 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 disclosures made in the accompanying notes to the financial statements. Actual results could differ from those estimates. RECLASSIFICATION Certain amounts in the 1995 and 1994 financial statements have been reclassified to conform with December 31, 1996 presentation. REVENUE RECOGNITION Revenue from collaborative agreements is recorded when earned as defined under the terms of the agreements. NET LOSS PER SHARE Net loss per share is computed using the weighted average number of common shares outstanding during the periods, as adjusted for the effects of certain rules of the Securities and Exchange Commission for the periods prior to the Company's initial public offering in June 1994. In addition, the calculation of the shares used in computing net loss per share includes shares of convertible preferred stock that converted into common stock in conjunction with the Company's initial public offering as if they had converted into common stock as of the original dates of issuance. CASH, CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS Cash and cash equivalents consist of cash and highly liquid investments which include debt securities with remaining maturities when acquired of three months or less and are stated at market. Short-term investments mainly consist of debt securities with maturities greater than three months. Management has classified the Company's cash equivalents and short-term investments as available-for-sale securities in the accompanying financial statements. Available-for-sale securities are carried at fair value, with unrealized gains and losses reported in a separate component of stockholders' equity. Realized gains and losses and declines in value judged to be other-than-temporary on available-for-sale securities are included in investment income. The cost of securities sold is based on the specific identification method. Interest and dividends on securities classified as available-for-sale are included in investment income. F-7 48 La Jolla Pharmaceutical Company Notes to Financial Statements 1. ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (CONTINUED) CONCENTRATION OF CREDIT RISK Cash, cash equivalents and short-term investments are financial instruments which potentially subject the Company to concentrations of credit risk. The Company deposits its cash in financial institutions. At times, such deposits may be in excess of insured limits. The Company invests its excess cash in U.S. Government securities and debt instruments of financial institutions and corporations with strong credit ratings. The Company has established guidelines relative to diversification of its cash investments and their maturities in an effort to maintain safety and liquidity. These guidelines are periodically reviewed and modified to take advantage of trends in yields and interest rates. To date, the Company has not experienced any losses on its cash, cash equivalents and short-term investments. PROPERTY AND EQUIPMENT Property and equipment is stated at cost and depreciated using the straight-line method over the estimated useful lives of the assets (primarily five years). Leasehold improvements are stated at cost and amortized on a straight-line basis over the shorter of the estimated useful life or the lease term. Equipment under capital leases is amortized over the shorter of the estimated useful life of the assets or the lease term and such amortization is included in depreciation in the accompanying financial statements. Property and equipment is comprised of the following (in thousands):
DECEMBER 31, 1996 1995 ------------------------------------ Laboratory equipment $ 3,384 $ 3,450 Computer equipment 511 389 Furniture and fixtures 597 547 Leasehold improvements 55 - ------------------------------------ 4,547 4,386 Less: accumulated depreciation and amortization (3,186) (2,461) ------------------------------------ $ 1,361 $ 1,925 ====================================
F-8 49 La Jolla Pharmaceutical Company Notes to Financial Statements 1. ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (CONTINUED) IMPAIRMENT OF LONG-LIVED ASSETS Effective January 1, 1996, the Company adopted SFAS No. 121 "Accounting for the Impairment of Long-Lived Assets and for Long-Lived Assets to be Disposed Of" ("SFAS 121"), which requires impairment losses to be recorded on long-lived assets used in operations when indicators of impairment are present and the estimated undiscounted cash flows to be generated by those assets are less than the assets' carrying amount. SFAS 121 also addresses the accounting for long-lived assets that are expected to be disposed of. The adoption of the SFAS 121 had no material effect on the Company's financial position or results of operations. PATENTS The Company has filed several patent applications in the United States Patent and Trademark Office and in foreign countries. Legal costs and expenses incurred in connection with pending patent applications have been deferred. Costs related to successful patent applications are amortized using the straight-line method over the lesser of the remaining useful life of the related technology or the remaining patent life, commencing on the date the patent is issued. Accumulated amortization at December 31, 1996 and 1995 was $49,000 and $75,000, respectively. Deferred costs related to patent applications are charged to operations at the time a determination is made not to pursue such applications. STOCK OPTIONS Effective January 1, 1996, the Company adopted SFAS No. 123, "Accounting and Disclosure of Stock-Based Compensation" ("SFAS 123"). As allowed under SFAS 123, the Company has elected to continue to account for stock option grants in accordance with Accounting Principles Board Opinion No. 25, "Accounting for Stock Issued to Employees" ("APB 25") and related interpretations. The Company generally grants stock options for a fixed number of shares to employees with an exercise price equal to the fair value of the shares at the date of grant and, under APB 25, recognizes no compensation expense for such stock option grants. The adoption of SFAS 123 had no material effect on the financial statements. F-9 50 La Jolla Pharmaceutical Company Notes to Financial Statements 2. COLLABORATIVE AGREEMENTS In December 1996, the Company entered into a collaborative agreement with Abbott, a diversified healthcare company. Under this agreement, in exchange for an exclusive, worldwide license to market and sell LJP 394, Abbott agreed to pay an initial license fee of $4,000,000 upon signing, and agreed to fund the development of the Company's lupus drug candidate, LJP 394, and to make certain payments to the Company upon the attainment of specific milestones. In addition, Abbott has agreed to make royalty and sales incentive payments to the Company on sales of LJP 394 while the Company retains worldwide manufacturing rights and ownership rights of all of its patents relating to the drug. Abbott also purchased common stock of the Company for an aggregate purchase price of $4,000,000 in December 1996, and the Company has the right to require Abbott to purchase up to $8,000,000 of additional shares of the Company's common stock over the next two years (up to $4,000,000 each year). Both Abbott and the Company have the right to terminate the agreement under certain circumstances. In May 1996, the Company terminated its agreement with Leo Pharmaceutical which was signed in September 1995. Under the original agreement, the Company had granted to Leo the exclusive rights to distribute LJP 394 in Europe and the Middle East. The Company terminated the relationship with Leo Pharmaceutical because the Company and Leo Pharmaceutical could not reach agreement regarding the timing and allocation of resources with respect to further clinical trials of LJP 394. Under the termination provisions of the original agreement, the Company retained the $3,000,000 payment previously received from Leo Pharmaceutical, and neither the Company nor Leo Pharmaceutical has any further obligations. 3. CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS The following is a summary of the estimated fair value of available-for-sale securities (in thousands):
DECEMBER 31, 1996 1995 ------------------------------------ Money market accounts $ 460 $ 13,400 U.S. corporate debt securities 10,901 9,805 Government asset backed securities 10,999 - U.S. Treasury securities and obligations of the U.S. government agencies 249 - ------------------------------------ $ 22,609 $ 23,205 ====================================
F-10 51 La Jolla Pharmaceutical Company Notes to Financial Statements 3. CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS (CONTINUED) As of December 31, 1996 and 1995, the difference between cost and estimated fair value of available-for-sale securities was not significant. Included in cash and cash equivalents at December 31, 1996 and 1995 were $4,988,000 and $19,358,000, respectively, of securities classified as available-for-sale. As of December 31, 1996, available-for-sale securities of $20,596,000 are due in one year or less and $2,013,000 are due after one year through two years. 4. COMMITMENTS LEASES In July 1992, the Company entered into a non-cancellable operating lease for the rental of its office and research and development facilities which expires in July 2004. The lease is subject to an escalation clause that provides for annual increases based on the consumer price index (CPI). The lease also contains an option to extend the lease term for an additional five years and a one-time cancellation option effective any time after August 1, 1998 with the payment of certain penalties. The lease also contains a construction allowance in the amount of $1,434,000 for approved tenant improvements to the facility. In June 1993, the Company entered into an equipment lease financing facility to finance up to $4,000,000 of equipment which was available until March 1995. As of December 31, 1996, the total amount of equipment financed under this capital lease was $3,188,000. In September 1995, the Company entered into an equipment lease financing facility to finance up to $1,500,000 of equipment which was available until December 1996. As of December 31, 1996, the total amount of equipment financed under this operating lease was $954,000. In October 1996, the Company entered into a non-cancellable operating lease for the rental of office and research and development facilities which expires in October 2001. The lease contains a provision for scheduled annual rent increases and an option to extend the lease term for an additional five years. The lease also contains a construction allowance in the amount of $168,000 for approved tenant improvements to the facility. In December 1996, the Company entered into an equipment and leasehold improvement lease financing facility to finance up to $4,000,000 of equipment and $1,000,000 of leasehold improvements which is available until December 1997. As of December 31, 1996, the total amount of equipment financed under this operating lease was $390,000. F-11 52 La Jolla Pharmaceutical Company Notes to Financial Statements 4. COMMITMENTS (CONTINUED) Annual future minimum lease payments as of December 31, 1996, which include $994,000 for the effect of exercising the facility operating lease cancellation option, are as follows (in thousands):
OPERATING CAPITAL LEASES LEASES ------------------------------------ 1997 $ 1,247 $ 696 1998 1,826 168 1999 324 9 2000 269 -- 2001 134 -- ------------------------------------ Total $ 3,800 873 ================== Less amount representing interest (63) ------------------- Present value of net minimum lease payments 810 Less current portion (642) ------------------- Noncurrent portion of capital lease obligations $ 168 ===================
Rent expense under all operating leases totaled $952,000, $545,000, and $485,000 for the years ended December 31, 1996, 1995 and 1994, respectively. Equipment under capital leases totaled $1,201,000 and $1,859,000 (net of accumulated amortization of $2,021,000 and $1,363,000) at December 31, 1996 and 1995, respectively. LICENSE AGREEMENT In September 1991, the Company entered into an exclusive license agreement for certain technology related to its inflammation program with The Regents of the University of California. Under the agreement, the Company is required to pay royalties on the sale of approved drugs employing the technology subject to a minimum annual royalty. To retain its exclusive license rights, the Company must meet and satisfy certain development milestones in addition to its royalty and other obligations under this agreement. The Company has the right to terminate the agreement at any time and failure to meet the above conditions could result in termination of the license. PURCHASE AGREEMENT In June 1994, the Company purchased certain scientific equipment. In connection with the purchase agreement, the Company may be required to make annual payments of $200,000 for a period of up to ten years, in the event that the equipment is used to produce materials for sale. F-12 53 La Jolla Pharmaceutical Company Notes to Financial Statements 5. STOCKHOLDERS' EQUITY PREFERRED STOCK As of December 31, 1996, the Company is authorized to issue 8,000,000 shares of preferred stock, in one or more series. PUBLIC OFFERINGS In June 1994, the Company completed an initial public offering of 2,990,000 Units (the "IPO") at a price of $5.00 per Unit. Each Unit consisted of one share of common stock and one redeemable warrant to purchase one-half of one share of common stock. The Company received net proceeds from the IPO of $12,702,000. Upon the closing of the IPO, all outstanding shares of preferred stock automatically converted into an aggregate of 3,941,063 shares of common stock and shareholder bridge notes and accrued interest totaling $4,167,000 converted into 833,517 Units. In connection with the IPO, the Underwriter was granted the option to purchase up to 260,000 additional Units at $8.00 per Unit. The purchase option expires on June 3, 1999. In June 1995, the Company completed a secondary public offering of 3,400,000 shares of common stock for net cash proceeds of $9,886,000. In October 1995, the Company issued 2,000,000 shares of common stock to an institutional investor for cash proceeds of $8,140,000. In July and August 1996, the Company completed an additional public offering of 2,140,000 shares of common stock for net cash proceeds of $9,774,000. In December 1996, the Company issued 1,000,050 shares of common stock to Abbott for total proceeds of $4,000,000. (See Note 2.) STOCKHOLDER BRIDGE NOTES In May 1994, the Company issued $4,156,000 of 8% bridge notes to existing stockholders. The terms of the bridge notes required the automatic conversion of the principal and accrued interest to Units at the price paid in the IPO. In addition, the notes provided for the granting of additional warrants to the holders equal to 20% of the Units into which the debt was converted. Those additional warrants permit the holders to purchase 166,697 shares of common stock at $5.00 per share through June 1999. At December 31, 1996, warrants to purchase 154,460 shares of common stock were outstanding. F-13 54 La Jolla Pharmaceutical Company Notes to Financial Statements 5. STOCKHOLDERS' EQUITY (CONTINUED) WARRANTS In connection with the IPO and the conversion of bridge notes, the Company issued 3,823,517 redeemable warrants. The redeemable warrant holders are entitled to purchase one-half of one share of common stock for each warrant at an exercise price of $3.00 per one-half share, subject to adjustment. The warrants are exercisable beginning June 3, 1995 until June 3, 1999. The Company is entitled to redeem the warrants on not less than 30 days written notice at $0.05 per warrant if the average closing bid price of the common stock exceeds 150% of the then-effective warrant exercise price for one share of common stock, over a period of 20 consecutive trading days, ending within 15 days of the date of notice of redemption. At December 31, 1996, 3,822,617 redeemable warrants were outstanding. In connection with capital lease agreements entered into during 1993 and 1994, the Company issued warrants to purchase 20,690 shares of the Company's common stock at $8.43 per share and 20,000 shares of the Company's common stock at $5.00 per share, respectively. These warrants expired on June 10 and June 3, 1996, respectively. As of December 31, 1996, 4,237,077 warrants were outstanding and 2,195,769 shares of common stock are reserved for issuance upon exercise of warrants. STOCK OPTION PLANS In May 1989, the Company adopted the 1989 Stock Option Plan and the 1989 Nonstatutory Stock Option Plan (the "1989 Plan"), under which 904,000 shares of common stock are reserved for issuance upon exercise of options granted by the Company. In June 1994, the Company adopted the 1994 Stock Incentive Plan (the "1994 Plan"), under which 1,250,000 shares of common stock are reserved for issuance upon exercise of options granted by the Company. The 1994 Plan provides for the grant of incentive and non-qualified stock options, as well as other stock based awards, to employees, consultants and advisors of the Company with various vesting periods as determined by the compensation committee, as well as automatic fixed grants to non-employee directors of the Company. F-14 55 La Jolla Pharmaceutical Company Notes to Financial Statements 5. STOCKHOLDERS' EQUITY (CONTINUED) A summary of the Company's stock option activity, and related data follows:
OUTSTANDING OPTIONS -------------------------------------- OPTIONS AVAILABLE NUMBER OF PRICE PER FOR GRANT SHARES SHARE ------------------------------------------------------- Balance at December 31, 1993 187,933 753,011 $1.00 Additional shares authorized 750,000 Granted (566,280) 566,280 $1.00-$5.25 Exercised (65,055) $1.00-$5.25 Cancelled 53,362 (53,362) $1.00-$2.00 ------------------------------------------------------- Balance at December 31, 1994 425,015 1,200,874 $1.00-$5.25 Granted (336,195) 336,195 $2.25-$4.31 Exercised (30,541) $1.00 Cancelled 44,490 (44,490) $1.00-$4.13 ------------------------------------------------------- Balance at December 31, 1995 133,310 1,462,038 $1.00-$5.25 Additional shares authorized 500,000 Granted (426,750) 426,750 $3.75-$8.31 Exercised (52,722) $1.00-$5.03 Cancelled 120,982 (120,982) $1.00-$7.88 ======================================================= Balance at December 31, 1996 327,542 1,715,084 $1.00-$8.31 =======================================================
YEARS ENDED DECEMBER 31, 1996 1995 ------------------------------------ ---------------------------------- WEIGHTED- WEIGHTED- AVERAGE AVERAGE OPTIONS EXERCISE PRICE OPTIONS EXERCISE PRICE ---------------- ------------------- -------------- ------------------- Outstanding - beginning of year 1,462,038 $2.40 1,200,874 $1.92 Granted 426,750 4.91 336,195 3.94 Exercised (52,722) 1.58 (30,541) 1.00 Forfeited (120,982) 2.98 (44,490) 2.26 -------------- ----------- Outstanding -end of year 1,715,084 $3.00 1,462,038 $2.40 ============== =========== Exercisable at end of year 931,465 720,588 Weighted-average fair value of options granted during the year $3.08 $2.48
F-15 56 La Jolla Pharmaceutical Company Notes to Financial Statements 5. STOCKHOLDERS' EQUITY (CONTINUED) Exercise prices and weighted-average remaining contractual lives for the options outstanding as of December 31, 1996 follows:
WEIGHTED-AVERAGE OPTIONS RANGE OF EXERCISE REMAINING WEIGHTED-AVERAGE OUTSTANDING PRICES CONTRACTUAL LIFE EXERCISE PRICE - ----------------------- -------------------------- -------------------------- ------------------------------ 712,385 $1.00 5.37 $1.00 430,230 $2.00 - $4.25 8.87 3.46 495,669 $4.31 - $5.25 8.59 4.79 76,800 $6.75 - $8.31 9.15 7.44 - ----------------------- 1,715,084 $1.00 - $8.31 7.35 $3.00 =======================
For certain options granted, the Company recognizes as compensation expense the excess of the deemed value for accounting purposes of the common stock issuable upon exercise over the aggregate exercise price of such options. Compensation expense is amortized ratably over the vesting period of each option. EMPLOYEE STOCK PURCHASE PLAN Effective August 1, 1995, the Company adopted the 1995 Employee Stock Purchase Plan (the "Purchase Plan") which was amended in July 1996. Under the amended Purchase Plan, a total of 300,000 shares of common stock are reserved for sale to full-time employees with six months of service. Employees may purchase common stock under the Purchase Plan every six months (up to but not exceeding 10% of each employee's earnings) over the offering period at 85% of the fair market value of the common stock at certain specified dates. The offering period may not exceed 24 months. For the year ended December 31, 1996, 27,658 shares of common stock had been issued under the Purchase Plan and 272,342 shares of common stock are available for issuance. STOCK-BASED COMPENSATION Pro forma information regarding net income and earnings per share is required by SFAS 123, which also requires that the information be determined as if the Company has accounted for its employee stock options granted after December 31, 1994 under the fair value method of that statement. The fair value for these options was estimated at the date of grant using a Black-Scholes option pricing model with the following weighted-average assumptions for both 1996 and 1995: risk-free interest rate of 6%; dividend yield of 0%; volatility factor of the expected market price of the Company's common stock of .70 ; and a weighted-average expected life of the option of five years. F-16 57 La Jolla Pharmaceutical Company Notes to Financial Statements 5. STOCKHOLDERS' EQUITY (CONTINUED) 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 employee stock options 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 its employee stock options. For purposes of pro forma disclosures, the estimated fair value of the options is amortized to expense over the options' vesting period. The Company's pro forma information follows (in thousands except for earnings per share information): YEARS ENDED DECEMBER 31, 1996 1995 -------------------- ---------------------- Pro forma net loss $ (9,970) $ (8,613) ==================== ====================== Pro forma net loss per share $ (.66) $ (.79) ==================== ====================== Because SFAS 123 is applicable only to options granted subsequent to December 31, 1994, its pro forma effect will not be fully recognized until 1997. 6. 401(k) PLAN The Company has established a 401(k) defined contribution retirement plan (the "401(k) Plan"), which was amended in July 1996, to cover all employees with one year of service. The Plan provides for voluntary employee contributions up to 20% of annual compensation (as defined). The Company does not match employee contributions or otherwise contribute to the Plan. 7. INCOME TAXES At December 31, 1996, the Company had federal and California income tax net operating loss carryforwards of approximately $44,997,000 and $3,709,000, respectively. The difference between the federal and California tax loss carryforwards is primarily attributable to the capitalization of research and development expenses for California income tax purposes and the 50% percent limitation on California loss carryforwards. The Company also had federal and California research tax credit carryforwards of $2,282,000 and $979,000, respectively. The federal net operating loss and tax credit carryforwards will begin to expire in 2004 unless previously utilized, while the California net operating loss carryforwards will begin to expire in 1997. F-17 58 La Jolla Pharmaceutical Company Notes to Financial Statements 7. INCOME TAXES (CONTINUED) In accordance with certain provisions of the Internal Revenue Code, a change in ownership of greater than 50% within a three-year period will place an annual limitation on the Company's ability to utilize its existing net operating loss and tax credit carryforwards. Due to the completion of the initial public offering in June 1994, the Company is subject to these annual limitations. However, the annual limitations are not expected to have a material effect on the Company's ability to utilize its net operating loss and tax credit carryforwards. Significant components of the Company's deferred tax assets are shown below (in thousands):
DECEMBER 31, 1996 1995 ------------------------------------ Deferred tax assets: Net operating loss carryforwards $ 16,000 $ 13,000 Research and development credits 3,000 3,000 Capitalized research and development 2,000 2,000 ------------------------------------ Total deferred tax assets 21,000 18,000 Valuation allowance for deferred tax assets (21,000) (18,000) ------------------------------------ Net deferred tax assets $ - $ - ====================================
A valuation allowance of $21,000,000 has been recognized to offset the deferred tax assets as realization of such assets is uncertain. F-18 59 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. LA JOLLA PHARMACEUTICAL COMPANY By: /s/ Steven B. Engle ____________________________________ Name: Steven B. Engle Title: Chairman of the Board and Chief Executive Officer March 27, 1997 Pursuant to the requirements of the Securities Exchange Act of 1934, this Report has been signed below by the following persons on behalf of the Registrant and in the capacities and on the dates indicated.
Signature Title Date --------- ----- ---- PRINCIPAL EXECUTIVE OFFICER AND DIRECTOR: /s/Steven B. Engle Chairman of the Board and March 27, 1997 ______________________________ Chief Executive Officer Steven B. Engle PRINCIPAL FINANCIAL AND ACCOUNTING OFFICER: /s/Wood C. Erwin Chief Financial Officer and March 27, 1997 ______________________________ Secretary Wood C. Erwin /s/Joseph Stemler Former Chairman of the Board March 27, 1997 ______________________________ and Director Joseph Stemler /s/Thomas H. Adams Director March 27, 1997 ______________________________ Thomas H. Adams, Ph.D. /s/William E. Engbers Director March 27, 1997 ______________________________ William E. Engbers /s/Robert A. Fildes Director March 27, 1997 ______________________________ Robert A. Fildes, Ph.D. /s/W. Leigh Thompson Director March 27, 1997 ______________________________ W. Leigh Thompson, M.D., Ph.D.
41 60 La Jolla Pharmaceutical Company Exhibit Index Exhibit Number Description - -------------- -------------------------------------------------------------- 10.34 Master Lease Agreement dated December 20, 1996 by and between the Company and Transamerica Business Credit Corporation 10.35 License and Supply Agreement dated December 23, 1996 by and between the Company and Abbott Laboratories 10.36 Stock Purchase Agreement dated December 23, 1996 by and between the Company and Abbott Laboratories 23.1 Consent of Ernst & Young LLP, Independent Auditors 27 Financial Data Schedule 42
EX-10.34 2 EXHIBIT 10.34 1 EXHIBIT 10.34 MASTER LEASE AGREEMENT Lessor: TRANSAMERICA BUSINESS CREDIT CORPORATION RIVERWAY II WEST OFFICE TOWER WEST HIGGINS ROAD Lessee: LA JOLLA PHARMACEUTICAL COMPANY 6455 NANCY RIDGE DRIVE SAN DIEGO, CALIFORNIA 92121 The lessor pursuant to this Master Lease Agreement ("Agreement") dated December 20, 1996 is Transamerica Business Credit Corporation ("Lessor"). All equipment, together with all present and future additions, parts, accessories, attachments, substitutions, repairs, improvements and replacements thereof or thereto, which are the subject of a Lease (as defined in the next sentence) shall be referred to as "Equipment." Simultaneously with the execution and delivery of this Agreement, the parties are entering into one or more Lease Schedules (each, a "Schedule") which refer to and incorporate by reference this Agreement, each of which constitutes a lease (each, a "Lease") for the Equipment specified therein. Additional details pertaining to each Lease are specified in the applicable Schedule. Each Schedule that the parties hereafter enter into shall constitute a Lease. Lessor has no obligation to enter into any additional leases with, or extend any future financing to, Lessee. 1. LEASE. Subject to and upon all of the terms and conditions of this Agreement and each Schedule, Lessor hereby agrees to lease to Lessee and Lessee hereby agrees to lease from Lessor the Equipment for the Term (as defined in Paragraph 2 below) thereof. 2. TERM. Each Lease shall be effective and the term of each Lease ("Term") shall commence on the commencement date specified in the applicable Schedule, as the same may be adjusted, in the sole discretion of Lessor pursuant to an Adjustment Letter (the "Adjustment Letter") (but in no event shall any Lease have a commencement date of later than December 30, 1997) and, unless sooner terminated (as hereinafter provided), shall expire at the end of the term specified in such Schedule; provided, however, that obligations due to be performed by the Lessee during the Term shall continue until they have been performed in full. Schedules will only be executed after the delivery of the Equipment to Lessee or upon completion of deliveries of items of such Equipment with aggregate cost of not less than $50,000.00. 3. RENT. Lessee shall pay as rent to Lessor, for use of the Equipment during the Term or Renewal Term (as defined in Paragraph 8), rental payments equal to the sum of all rental payments including without limitation, security deposits, advance rents and interim rents payable in the amounts and on the dates specified in the applicable Schedule ("Rent"). If any Rent or other amount payable by Lessee is not paid within three days after the day on which it becomes payable, Lessee will pay on demand, as a late charge, an amount equal to 5% of such unpaid Rent or other amount but only to the extent permitted by applicable law. All payments provided for herein shall be payable to Lessor at its address specified above, or at any other place designated by Lessor. 4. LEASE NOT CANCELABLE; LESSEE'S OBLIGATIONS ABSOLUTE. No Lease may be canceled or terminated except as expressly provided herein. Lessee's obligation to pay all Rent due or to become due hereunder shall be absolute and unconditional and shall not be subject to any delay, reduction, set-off, defense, counterclaim or recoupment for any reason whatsoever, including any failure of the Equipment or any representations by the manufacturer or the vendor thereof. If the Equipment is unsatisfactory for any reason, Lessee shall make any claim solely against the manufacturer or the vendor thereof and shall, nevertheless, pay Lessor all Rent payable hereunder. 2 5. SELECTION AND USE OF EQUIPMENT. Lessee agrees that it shall be responsible for the selection, use of, and results obtained from, the Equipment and any other associated equipment or services. 6. WARRANTIES. LESSOR MAKES NO REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, AS TO ANY MATTER WHATSOEVER, INCLUDING, WITHOUT LIMITATION, THE DESIGN OR CONDITION OF THE EQUIPMENT OR ITS MERCHANTABILITY, SUITABILITY, QUALITY OR FITNESS FOR A PARTICULAR PURPOSE, AND HEREBY DISCLAIMS ANY SUCH WARRANTY. LESSEE SPECIFICALLY WAIVES ALL RIGHTS TO MAKE A CLAIM AGAINST LESSOR FOR BREACH OF ANY WARRANTY WHATSOEVER. LESSEE LEASES THE EQUIPMENT "AS IS." IN NO EVENT SHALL LESSOR HAVE ANY LIABILITY FOR, NOR SHALL LESSEE HAVE ANY REMEDY AGAINST LESSOR FOR, ANY LIABILITY, CLAIM, LOSS, DAMAGE OR EXPENSE CAUSED DIRECTLY OR INDIRECTLY BY THE EQUIPMENT OR ANY DEFICIENCY OR DEFECT THEREOF OR THE OPERATION, MAINTENANCE OR REPAIR THEREOF OR ANY CONSEQUENTIAL DAMAGES AS THAT TERM IS USED IN SECTION 2-719(3) OF THE MODEL UNIFORM COMMERCIAL CODE OR SIMILAR STATUTE ("UCC"). Lessor grants to Lessee, for the sole purpose of prosecuting a claim, the benefits of any and all warranties made available by the manufacturer or the vendor of the Equipment to the extent assignable. 7. DELIVERY. Lessor hereby appoints Lessee as Lessor's agent for the sole and limited purpose of accepting delivery of the Equipment from each vendor thereof. Lessee shall pay any and all delivery and installation charges. Lessor shall not be liable to Lessee for any delay in, or failure of, delivery of the Equipment. 8. RENEWAL. So long as no Event of Default or event, which with the giving of notice, the passage of time, or both, would constitute an Event of Default, shall have occurred and be continuing, or the Lessee shall not have exercised its purchase option under Paragraph 9 hereof, the Lease will automatically renew for a term of twelve months (the "Renewal Term") on the terms and conditions set forth in the applicable Schedule, provided, however, that obligations due to be performed by the Lessee during the Renewal Term shall continue until they have been performed in full. The monthly rental payments for the Renewal Term shall be equal to 1.25% of the equipment cost plus any monthly sales or use tax. 9. PURCHASE OPTION. So long as no Event of Default or event which, with the giving of notice, the passage of time, or both, would constitute an Event of Default, shall have occurred and be continuing, Lessee may, upon written notice to Lessor received at least one hundred eighty days before the expiration of a Term, purchase all, but not less than all, the Equipment covered by the applicable Lease on the date specified therefor in the applicable Schedule ("Purchase Date"). The purchase price for such Equipment shall be its fair market value on an "In-place, In-use" basis, as mutually agreed by Lessor and Lessee, or, if they cannot agree, as determined by an independent appraiser selected by Lessor and approved by Lessee, which approval will not be unreasonably delayed or withheld. Lessee shall pay the cost of any such appraisal. Notwithstanding the generality of the foregoing, Lessor and Lessee agree that on the Purchase Date, the fair market value of the Equipment shall not be less than 12.5% of equipment cost. So long as no Event of Default or event which, with the giving of notice, the passage of time, or both, would constitute an Event of Default, shall have occurred and be continuing, Lessee may, upon written notice to Lessor received at least one hundred eighty days prior to the expiration of the Renewal Term, purchase all, but not less than all, the Equipment covered by the applicable Schedule by the date specified therein (the "Second Purchase Date") at a purchase price equal to its then fair market value on an "In-place, In-use" basis. On the Purchase Date or the Second Purchase Date, as the case may be, for any Equipment, Lessee shall pay to Lessor the applicable purchase price, together with all sales and other taxes applicable to the transfer of such Equipment and any other amount payable hereunder, in immediately available funds, whereupon Lessor shall transfer to Lessee, without recourse or warranty of any kind, express or implied, all of the Lessor's right, title and interest in and to such Equipment on an "As is, Where is" basis. 10. OWNERSHIP; INSPECTION; MARKING; FINANCING STATEMENTS. Lessee shall affix to the Equipment any labels supplied by Lessor indicating ownership of such Equipment. The Equipment is and shall be the sole property of Lessor. Lessee shall have no right, title or interest therein, except as lessee under a Lease. The Equipment is and shall at all times be and remain personal property and 2 3 shall not become a fixture, other than Equipment consisting of tenant improvements. Lessee shall obtain and record such instruments and take such steps as may be necessary to prevent any Person from acquiring any rights in the Equipment, other than Equipment consisting of tenant improvements, by reason of the Equipment being claimed or deemed to be real property. Upon request by Lessor, Lessee shall obtain and deliver to Lessor valid and effective waivers, in recordable form, by the owners, landlords and mortgagees of the real property upon which the Equipment is located or certificates of Lessee that it is the owner of such real property or that such real property is neither leased nor mortgaged. Lessee shall make the Equipment and its maintenance records available for inspection by Lessor at reasonable times and upon reasonable notice. Lessee shall execute and deliver to Lessor for filing any UCC financing statements or similar documents Lessor may request. 11. EQUIPMENT USE. Lessee agrees that the Equipment will be operated by competent, qualified personnel in connection with Lessee's business for the purpose for which the Equipment was designed and in accordance with applicable operating instructions, laws and government regulations, and that Lessee shall use every reasonable precaution to prevent loss or damage to the Equipment from fire and other hazards. Lessee shall procure and maintain in effect all orders, licenses, certificates, permits, approvals and consents required by federal, state or local laws or by any governmental body, agency or authority in connection with the delivery, installation, use and operation of the Equipment. 12. MAINTENANCE. Lessee, at its sole cost and expense, shall keep the Equipment in a suitable environment as specified by the manufacturer's guidelines or the equivalent and meet all recertification requirements, and shall maintain the Equipment in its original condition and working order, ordinary wear and tear excepted. At the request of Lessor, Lessee shall furnish all proof of maintenance. 13. ALTERATION; MODIFICATIONS; PARTS. Lessee may alter or modify the Equipment only with the prior written consent of Lessor. Any alteration shall be removed and the Equipment restored to its normal, unaltered condition at Lessee's expense (without damaging the Equipment's originally intended function or its value) prior to its return to Lessor. Any part installed in connection with warranty or maintenance service or which cannot be removed in accordance with the preceding sentence shall be the property of Lessor. 14. RETURN OF EQUIPMENT. Except for Equipment that has suffered a Casualty Loss (as defined in Paragraph 15 below) and is not required to be repaired pursuant to Paragraph 15 below or Equipment purchased by Lessee pursuant to Paragraph 9 above, upon expiration or termination of the Term or the Renewal Term of a Lease, or upon demand by Lessor pursuant to Paragraph 22 below, Lessee shall contact Lessor for shipping instructions and, at Lessee's own risk, immediately return the Equipment, freight prepaid, to a location in the continental United States specified by Lessor. At the time of such return to Lessor, the Equipment shall (i) be in the operating order, repair and condition as required by or specified in the original specifications and warranties of each manufacturer and vendor thereof, ordinary wear and tear excepted, and meet all recertification requirements and (ii) be capable of being immediately assembled and operated by a third party purchaser or third party lessee without further repair, replacement, alterations or improvements, and in accordance and compliance with any and all statutes, laws, ordinances, rules and regulations of any governmental authority or any political subdivision thereof applicable to the use and operation of the Equipment. Except as otherwise provided under Paragraph 9 hereof, at least one hundred eighty days before the expiration of the Renewal Term, Lessee shall give Lessor notice of its intent to return the Equipment at the end of such Renewal Term. During the one hundred eighty-day period prior to the end of a Term or the Renewal Term, Lessor and its prospective purchasers or lessees shall have the right of access to the premises on which the Equipment is located to inspect the Equipment, and Lessee shall cooperate in all other respects with Lessor's remarketing of the Equipment. The provisions of this Paragraph 14 are of the essence of the Lease, and upon application to any court of equity having jurisdiction in the premises, Lessor shall be entitled to a decree against Lessee requiring specific performance of the covenants of Lessee set forth in this Paragraph 14. If Lessee fails to return Equipment when required, the terms and conditions of the Lease shall continue to be applicable and Lessee shall continue to pay Rent until the Equipment is received by Lessor. 15. CASUALTY INSURANCE; LOSS OR DAMAGE. Lessee will maintain, at its own expense, liability and property damage insurance relating the Equipment, insuring against such risks as are customarily insured against on the type of equipment leased hereunder by businesses in which Lessee is engaged in such amounts, in such form, and with insurers satisfactory to Lessor; provided, however, that the 3 4 amount of insurance against damage or loss shall not be less than the greater of (a) the replacement value of the Equipment and (b) the stipulated loss value of the Equipment specified in the applicable Schedule ("Stipulated Loss Value"). Each liability insurance policy shall provide coverage (including contractual and personal injury coverage) of not less than $1,000,000 for each occurrence, name Lessor as an additional insured and be primary as respects of any other insurance. Each property damage policy shall name Lessor as sole loss payee and all policies shall contain a clause requiring the insurer to give Lessor at least thirty days prior written notice of any alteration in the terms or cancellation of the policy. Lessee shall furnish a copy of each insurance policy (with endorsements) or other evidence satisfactory to Lessor that the required insurance coverage is in effect; provided, however, Lessor shall have no duty to ascertain the existence of or to examine the insurance policies to advise Lessee if the insurance coverage does not comply with the requirements of this Paragraph. If Lessee fails to insure the Equipment as required, Lessor shall have the right but not the obligation to obtain such insurance, and the cost of the insurance shall be for the account of Lessee due as part of the next due Rent. Lessee consents to Lessor's release, upon its failure to obtain appropriate insurance coverage, of any and all information necessary to obtain insurance with respect to the Equipment or Lessor's interest therein. Until the Equipment is returned to and received by Lessor as provided in Paragraph 14 above, Lessee shall bear the entire risk of theft or destruction of, or damage to, the Equipment including, without limitation, any condemnation, seizure or requisition of title or use ("Casualty Loss"). No Casualty Loss shall relieve Lessee from its obligations to pay Rent except as provided in clause (b) below. When any Casualty Loss occurs, Lessee shall immediately notify Lessor and, at the option of Lessor, shall promptly (a) place such Equipment in good repair and working order; or (b) pay Lessor an amount equal to the Stipulated Loss Value of such Equipment and all other amounts (excluding Rent) payable by Lessee hereunder, together with a late charge on such amounts at a rate per annum equal to the rate imputed in the Rent payments hereunder (as reasonably determined by Lessor) from the date of the Casualty Loss through the date of payment of such amounts, whereupon Lessor shall transfer to Lessee, without recourse or warranty (express or implied), all of Lessor's interest, if any, in and to such Equipment on an "AS IS, WHERE IS" basis. The proceeds of any insurance payable with respect to the Equipment shall be applied, at the option of Lessor, either towards (i) repair of the Equipment or (ii) payment of any of Lessee's obligations hereunder. Lessee hereby appoints Lessor as Lessee's attorney-in-fact to make claim for, receive payment of, and execute and endorse all documents, checks or drafts issued with respect to any Casualty Loss under any insurance policy relating to the Equipment. 16. TAXES. Lessee shall pay when due, and indemnify and hold Lessor harmless from, all sales, use, excise and other taxes, charges, and fees (including, without limitation, income, franchise, business and occupation, gross receipts, sales, use, licensing, registration, titling, personal property, stamp and interest equalization taxes, levies, imposts, duties, charges or withholdings of any nature), and any fines, penalties or interest thereon, imposed or levied by any governmental body, agency or tax authority upon or in connection with the Equipment, its purchase, ownership, delivery, leasing, possession, use or relocation of the Equipment or otherwise in connection with the transactions contemplated by each Lease or the Rent thereunder, excluding taxes on or measured by the net income of Lessor. Upon request, Lessee will provide proof of payment. Unless Lessor elects otherwise, Lessor will pay all property taxes on the Equipment for which Lessee shall reimburse Lessor promptly upon request. Lessee shall timely prepare and file all reports and returns which are required to be made with respect to any obligation of Lessee under this Paragraph 16. Lessee shall, to the extent permitted by law, cause all billings of such fees, taxes, levies, imposts, duties, withholdings and governmental charges to be made to Lessor in care of Lessee. Upon request, Lessee will provide Lessor with copies of all such billings. 17. LESSOR'S PAYMENT. If Lessee fails to perform its obligations under Paragraph 15 or 16 above, or Paragraph 23 below, Lessor shall have the right to substitute performance, in which case, Lessee shall immediately reimburse Lessor therefor. 18. GENERAL INDEMNITY. Each Lease is a net lease. Therefore, Lessee shall indemnify Lessor and its successors and assigns against, and hold Lessor and its successors and assigns harmless from, any and all claims, actions, damages, obligations, liabilities and all costs and expenses, including, without limitation, legal fees, incurred by Lessor or its successors and assigns arising out of each Lease including, without limitation, the purchase, ownership, delivery, lease, possession, maintenance, condition, use or return of the Equipment, or arising by operation of law. Lessee agrees that upon written 4 5 notice by Lessor of the assertion of any claim, action, damage, obligation, liability or lien, Lessee shall assume full responsibility for the defense thereof. Any payment pursuant to this Paragraph (except for any payment of Rent) shall be of such amount as shall be necessary so that, after payment of any taxes required to be paid thereon by Lessor, including taxes on or measured by the net income of Lessor, the balance will equal the amount due hereunder. The provisions of this Paragraph with regard to matters arising during a Lease shall survive the expiration or termination of such Lease. 19. ASSIGNMENT BY LESSEE. Lessee shall not, without the prior written consent of Lessor, (a) assign, transfer, pledge or otherwise dispose of any Lease or Equipment, or any interest therein; (b) sublease or lend any Equipment or permit it to be used by anyone other than Lessee and its employees; or (c) move any Equipment from the location specified for it in the applicable Schedule, except that Lessee may move Equipment to another location within the United States provided that Lessee has delivered to Lessor (A) prior written notice thereof and (B) duly executed financing statements and other agreements and instruments (all in form and substance satisfactory to Lessor) necessary or, in the opinion of the Lessor, desirable to protect Lessor's interest in such Equipment. Notwithstanding anything to the contrary in the immediately preceding sentence, Lessee may keep any Equipment consisting of motor vehicles or rolling stock at any location in the United States. 20. ASSIGNMENT BY LESSOR. Lessor may assign its interest or grant a security interest in any Lease and the Equipment individually or together, in whole or in part. If Lessee is given written notice of any such assignment, it shall immediately make all payments of Rent and other amounts hereunder directly to such assignee. Each such assignee shall have all of the rights of Lessor under each Lease assigned to it. Lessee shall not assert against any such assignee any set-off, defense or counterclaim that Lessee may have against Lessor or any other person. 21. DEFAULT; NO WAIVER. Lessee or any guarantor of any or all of the obligations of Lessee hereunder (together with Lessee, the "Lease Parties") shall be in default under each Lease upon the occurrence of any of the following events (each, an "Event of Default"): (a) Lessee fails to pay when due any amount required to be paid by Lessee under or in connection with any Lease; (b) any of the Lease Parties fails to perform any other provisions under or in connection with a Lease or violates any of the covenants or agreements of such Lease Party under or in connection with a Lease; (c) any representation made or financial information delivered or furnished by any of the Lease Parties under or in connection with a Lease shall prove to have been inaccurate in any material respect when made; (d) any of the Lease Parties makes an assignment for the benefit of creditors, whether voluntary or involuntary, or consents to the appointment of a trustee or receiver, or if either shall be appointed for any of the Lease Parties or for a substantial part of its property without its consent and, in the case of any such involuntary proceeding, such proceeding remains undismissed or unstayed for forty-five days following the commencement thereof; (e) any petition or proceeding is filed by or against any of the Lease Parties under any Federal or State bankruptcy or insolvency code or similar law and, in the case of any such involuntary petition or proceeding, such petition or proceeding remains undismissed or unstayed for forty-five days following the filing or commencement thereof, or any of the Lease Parties takes any action authorizing any such petition or proceeding; (f) any of the Lease Parties fails to pay when due any indebtedness for borrowed money or under conditional sales or installment sales contracts or similar agreements, leases or obligations evidenced by bonds, debentures, notes or other similar agreements or instruments to any creditor (including Lessor under any other agreement) after any and all applicable cure periods therefor shall have elapsed; (g) any judgment shall be rendered against any of the Lease Parties which shall remain unpaid or unstayed for a period of sixty days; (h) any of the Lease Parties shall dissolve, liquidate, wind up or cease its business, sell or otherwise dispose of all or substantially all of its assets make any material change in its capital structure or lines of business, amend or modify its name, merge or consolidate with any other entity, suffer any loss or suspension of any license, permit or other right or asset necessary to the profitable conduct of its business, fail to pay its debts as they mature, or call a meeting for purposes of compromising its debts; (i) any of the Lease Parties shall deny or disaffirm its obligations hereunder or under any of the documents delivered in connection herewith; (j) there is a change in the ownership of any equity or ownership interest of any of the Lease Parties or any such interest becomes subject to any contractual, judicial or statutory lien, charge, security interest or encumbrance; or (k) Lessor, in its reasonable judgment, shall deem itself insecure. 5 6 22. REMEDIES. Upon the occurrence and continuation of an Event of Default, Lessor shall have the right, in its sole discretion, to exercise any one or more of the following remedies: (a) terminate each Lease; (b) declare any and all Rent and other amounts then due and any and all Rent and other amounts to become due under each Lease immediately due and payable; (c) take possession of any or all items of Equipment, wherever located, without demand, notice, court order or other process of law, and without liability for entry to Lessee's premises, for damage to Lessee's property or otherwise; (d) demand that Lessee return any or all Equipment to Lessor in accordance with Paragraph 14 above, and, for each day that Lessee shall fail to return any item of Equipment, Lessor may demand an amount equal to the Rent payable for such Equipment in accordance with Paragraph 14 above; (e) lease, sell or otherwise dispose of the Equipment in a commercially reasonable manner, with or without notice and on public or private bid; (f) recover the following amounts from the Lessee (as damages, including reimbursement of costs and expenses, liquidated for all purposes and not as a penalty): (i) all costs and expenses of Lessor reimbursable to it hereunder, including, without limitation, expenses of disposition of the Equipment, legal fees and all other amounts specified in Paragraph 23 below; (ii) an amount equal to the sum of (A) any accrued and unpaid Rent through the later of (1) the date of the applicable default or (2) the date that Lessor has obtained possession of the Equipment or such other date as Lessee has made an effective tender of possession of the Equipment to Lessor (the "Default Date") and (B) if Lessor resells or re-lets the Equipment, Rent at the periodic rate provided for in each Lease for the additional period that it takes Lessor to resell or re-let all of the Equipment; (iii) the present value of all future Rent reserved in the Leases and contracted to be paid over the unexpired Term of the Leases discounted at five percent simple interest per annum; (iv) the residual value of the Equipment as of the expiration of the Term of the applicable Lease, which the parties agree to be twenty-five percent (25%) of the original cost of the Equipment; and (v) any indebtedness for Lessee's indemnity under Paragraph 18 above, plus a late charge at the rate specified in Paragraph 3 above, less the amount received by Lessor, if any, upon sale or re-let of the Equipment; and (g) exercise any other right or remedy to recover damages or enforce the terms of the Leases. Lessor may pursue any other rights or remedies available at law or in equity, including, without limitation, rights or remedies seeking damages, specific performance and injunctive relief. Any failure of Lessor to require strict performance by Lessee, or any waiver by Lessor of any provision hereunder or under any Schedule, shall not be construed as a consent or waiver of any other breach of the same or of any other provision. Any amendment or waiver of any provision hereof or under any Schedule or consent to any departure by Lessee herefrom or therefrom shall be in writing and signed by Lessor. No right or remedy is exclusive of any other provided herein or permitted by law or equity. All such rights and remedies shall be cumulative and may be enforced concurrently or individually from time to time. 23. LESSOR'S EXPENSE. Lessee shall pay Lessor on demand all fees and expenses in protecting and enforcing Lessor's rights and interests in each Lease and the Equipment, including, without limitation, legal, collection and remarketing fees and expenses incurred by Lessor in enforcing the terms, conditions or provisions of each Lease upon the occurrence and continuation of an Event of Default. 24. LESSEE'S WAIVERS. To the extent permitted by applicable law, Lessee hereby waives any and all rights and remedies conferred upon a lessee by Sections 2A-508 through 2A-522 of the UCC. To the extent permitted by applicable law, Lessee also hereby waives any rights now or hereafter conferred by statute or otherwise which may require Lessor to sell, lease or otherwise use any Equipment in mitigation of Lessor's damages as set forth in Paragraph 22 above or which may otherwise limit or modify any of Lessor's rights or remedies under Paragraph 22. Any action by Lessee against Lessor for any default by Lessor under any Lease shall be commenced within one year after any such cause of action accrues. 25. NOTICES; ADMINISTRATION. Except as otherwise provided herein, all notices, approvals, consents, correspondence or other communications required or desired to be given hereunder shall be given in writing and shall be delivered by overnight courier, hand delivery or certified or registered mail, postage prepaid, if to Lessor, then to Technology Finance Division, 406 Farmington Avenue, Farmington, Connecticut 06032, Attention: Assistant Vice President, Lease Administration, with a copy to Lessor at Riverway II, West Office Tower, 9399 West Higgins Road, Rosemont, Illinois 60018, Attention: Legal Department, if to Lessee, then to La Jolla Pharmaceutical Company, 6455 Nancy Ridge Drive, San Diego, California 92121, Attention: Vice President and Chief Financial Officer or such other address as shall be 6 7 designated by Lessee or Lessor to the other party. All such notices and correspondence shall be effective when received. 26. REPRESENTATIONS. Lessee represents and warrants to Lessor that (a) Lessee is duly organized, validly existing and in good standing under the laws of the State of its incorporation; (b) the execution, delivery and performance by Lessee of this Agreement are within Lessee's powers, have been duly authorized by all necessary action, and do not contravene (i) Lessee's organizational documents or (ii) any law or contractual restriction binding on or affecting Lessee; (c) no authorization or approval or other action by, and no notice to or filing with, any governmental authority or regulatory body is required for the due execution, delivery and performance by Lessee of this Agreement; and (d) each Lease constitutes the legal, valid and binding obligations of Lessee enforceable against Lessee in accordance with its terms. 27. FURTHER ASSURANCES. Lessee, upon the request of Lessor, will execute, acknowledge, record or file, as the case may be, such further documents and do such further acts as may be reasonably necessary, desirable or proper to carry out more effectively the purposes of this Agreement. Lessee hereby appoints Lessor as its attorney-in-fact to execute on behalf of Lessee and authorizes Lessor to file without Lessee's signature any UCC financing statements and amendments Lessor deems advisable. 28. FINANCIAL STATEMENTS. Lessee shall deliver to Lessor; (a) as soon as available, but not later than 120 days after the end of each fiscal year of Lessee and its consolidated subsidiaries, the consolidated balance sheet, income statement and statements of cash flows and shareholders equity for Lessee and its consolidated subsidiaries (the "Financial Statements") for such year, reported on by independent certified public accountants without an adverse qualification; and (b) as soon as available, but not later than 60 days after the end of each of the first three fiscal quarters in any fiscal year of Lessee and its consolidated subsidiaries, the Financial Statements for such fiscal quarter, together with a certification duly executed by a responsible officer of Lessee that such Financial Statements have been prepared in accordance with generally accepted accounting principles and are fairly stated in all material respects (subject to normal year-end audit adjustments). 29. CONSENT TO JURISDICTION. Lessee irrevocably submits to the jurisdiction of any Illinois state or federal court sitting in Illinois for any action or proceeding arising out of or relating to this Agreement or the transactions contemplated hereby, and Lessee irrevocably agrees that all claims in respect of any such action or proceeding may be heard and determined in such Illinois state or federal court. 30. WAIVER OF JURY TRIAL. LESSEE AND LESSOR IRREVOCABLY WAIVE ALL RIGHT TO TRIAL BY JURY IN ANY ACTION, PROCEEDING OR COUNTERCLAIM ARISING OUT OF OR RELATING TO THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED HEREBY. 31. FINANCE LEASE. Lessee and Lessor agree that each Lease is a "Finance Lease" as defined by Section 2A-103(g) of the UCC. Lessee acknowledges that Lessee has reviewed and approved each written Supply Contract (as defined by UCC 2A-103(y)) covering Equipment purchased from each "Supplier" (as defined by UCC 2A-103(x)) thereof. 32. NO AGENCY. Lessee acknowledges and agrees that neither the manufacturer or supplier, nor any salesman, representative or other agent of the manufacturer or supplier, is an agent of Lessor. No salesman, representative or agent of the manufacturer or supplier is authorized to waive or alter any term or condition of this Agreement or any Schedule and no representation as to the Equipment or any other matter by the manufacturer or supplier shall in any way affect Lessee's duty to pay Rent and perform its other obligations as set forth in this Agreement or any Schedule. 33. SPECIAL TAX INDEMNIFICATION. Lessee acknowledges that Lessor, in determining the Rent due hereunder, has assumed that certain tax benefits as are provided to an owner of property under the Internal Revenue Code of 1986, as amended (the "Code"), and under applicable state tax law, including, without limitation, depreciation deductions under Section 168(b) of the Code, and deductions under Section 163 of the Code in an amount at least equal to the amount of interest paid or accrued by Lessor with respect to any indebtedness incurred by Lessor in financing its purchase of the Equipment, are available to 7 8 Lessor as a result of the lease of the Equipment. In the event Lessor is unable to obtain such tax benefits for any reason, is required to include in income any amount other than the Rent or is required to recognize income in respect of the Rent earlier than anticipated pursuant to this Agreement, Lessee shall pay Lessor additional rent ("Additional Rent") in a lump sum in an amount needed to provide Lessor with the same after-tax yield and after-tax cash flow as would have been realized by Lessor had Lessor (i) been able to obtain such tax benefits, (ii) not been required to include any amount in income other than the Rent and (iii) not been required to recognize income in respect of the Rent earlier than anticipated pursuant to this Agreement. The Additional Rent shall be computed by Lessor, which computation shall be binding on Lessee. The Additional Rent shall be due immediately upon written notice by Lessor to Lessee of Lessor's inability to obtain tax benefits, the inclusion of any amount in income other than the rent or the recognition of income in respect of the Rent earlier than anticipated pursuant to the Agreement. The provisions of this Paragraph 33 shall survive the termination of this Agreement. 34. GOVERNING LAW; SEVERABILITY. EACH LEASE SHALL BE GOVERNED BY THE LAWS OF THE STATE OF ILLINOIS. IF ANY PROVISION SHALL BE HELD TO BE INVALID OR UNENFORCEABLE, THE VALIDITY AND ENFORCEABILITY OF THE REMAINING PROVISIONS SHALL NOT IN ANY WAY BE AFFECTED OR IMPAIRED. LESSEE ACKNOWLEDGES THAT LESSEE HAS READ THIS AGREEMENT AND THE SCHEDULE HERETO, UNDERSTANDS THEM, AND AGREES TO BE BOUND BY THEIR TERMS AND CONDITIONS. FURTHER, LESSEE AND LESSOR AGREE THAT THIS AGREEMENT AND THE SCHEDULES DELIVERED IN CONNECTION HEREWITH FROM TIME TO TIME ARE THE COMPLETE AND EXCLUSIVE STATEMENT OF THE AGREEMENT BETWEEN THE PARTIES, SUPERSEDING ALL PROPOSALS OR PRIOR AGREEMENTS, ORAL OR WRITTEN, AND ALL OTHER COMMUNICATIONS BETWEEN THE PARTIES RELATING TO THE SUBJECT MATTER HEREOF. IN WITNESS WHEREOF, the parties hereto have executed or caused this Master Lease Agreement to be duly executed by their duly authorized officers as of this 20th day of December, 1996. LA JOLLA PHARMACEUTICAL COMPANY By /s/ Wood C. Erwin ---------------------------------- Title: Vice President and Chief Financial Officer FED ID NO. 330-36-128 ---------- TRANSAMERICA BUSINESS CREDIT CORPORATION By /s/ Gary P. Moro ---------------------------------- Title: Vice President 8 EX-10.35 3 EXHIBIT 10.35 1 EXHIBIT 10.35 *** DESIGNATED PORTIONS OF THIS EXHIBIT 10.35 HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES AND EXCHANGE ACT OF 1934. LICENSE AND SUPPLY AGREEMENT This License and Supply Agreement ("Agreement") is made and entered into as of the 23rd day of December, 1996 ("Effective Date") by and between LA JOLLA PHARMACEUTICAL COMPANY, a corporation organized and existing under the laws of the State of Delaware and having its principal office at 6455 Nancy Ridge Drive, San Diego, California, USA 92121 ("LJP"), and ABBOTT LABORATORIES, a corporation organized and existing under the laws of the State of Illinois, and having its principal office at 100 Abbott Park Road, Abbott Park, Illinois, USA 60064-3500 ("Abbott"). WHEREAS, LJP has expertise regarding research and development and has developed a novel and patented technology for the treatment of Systemic Lupus Erythematosus ("SLE"); WHEREAS, Abbott has expertise regarding research and development, clinical development, marketing and sale of pharmaceutical products; WHEREAS, LJP has identified a candidate compound (LJP 394) currently in Phase II/III clinical trials and suitable for further development as a drug for the treatment of SLE; and WHEREAS, Abbott and LJP are interested in collaborating in the development and marketing of LJP 394 and/or related compounds thereof; NOW, THEREFORE, for and in consideration of the mutual covenants contained herein, the parties hereto agree as follows: 1 2 ARTICLE I DEFINITIONS For purposes of this Agreement, the following terms shall be defined as set forth below. Additional terms used in specific Sections of this Agreement shall be defined in such Sections . 1.1 "ABBOTT REGULATORY KNOW-HOW" shall mean all Abbott owned or controlled present and future non-patented and unpublished regulatory documentation, information and data, as well as the organization and compilation of the data, including but not limited to all the data and information contained in governmental registrations required for marketing Product. 1.2 "ABBOTT TRADEMARKS" shall mean the trademarks Abbott selects for and applies to the Product in the Territory in accordance with Section 9.1 of this Agreement. 1.3 "AFFILIATE" shall mean any business entity controlled by a Party (as defined below), or which controls a Party, or which is under common control with a Party. "Control" herein means the direct or indirect ownership of more than fifty percent (50%) of the authorized issued voting shares in such entity, or such other relationship as results in effective control over the management, business and affairs of such entity or Party, as the case may be. A business entity shall be deemed an Affiliate of a Party only so long as such control relationship exists. For purposes of this Agreement, Abbott Affiliates shall also include the following entities: ***. For purposes of this Agreement, Abbott Affiliates shall exclude TAP Holdings, Inc., and TAP Pharmaceuticals, Inc. 1.4 "ANNUAL NET SALES" shall mean Net Sales (as defined below) recorded in any calendar year. 1.5 "BACK-UP COMPOUNDS" shall mean compounds other than LJP 394 that ***. 2 3 1.6 "CALENDAR QUARTER" shall mean each of the three (3) month periods beginning on January 1, April 1, July 1 and October 1 of each year during the Term (as defined below). 1.7 "COMBINATION PRODUCT" shall mean a pharmaceutical product containing the Product (as defined below) and at least one (1) other therapeutically active ingredient. 1.8 "COMMERCIALLY REASONABLE EFFORTS" shall mean a level of effort by a Party equivalent to the degree of the effort the Party uses to develop (for purposes of Section 6.1), file and obtain Regulatory Approvals (for purposes of Section 6.1(A and C)), launch (for purposes of Section 7.1), market (for purposes of Section 7.2), obtain patent extension for (for purposes of Section 11.1), prevent unauthorized export or sale of (for purposes of Section 20.1 (D)), or manufacture and supply (for purposes of Sections 1.2, 4.2 (D) and 5 of the Supply Agreement), as applicable, products having a comparable proprietary position and market potential as the Product in the applicable countries during the same time period. 1.9 "COMPETING PRODUCT" shall mean ***. 3 4 1.10 "COMPETITION" shall mean the presence on the market in a given country where no Valid Claims exist of a product chemically similar or functionally equivalent to the Product marketed and sold by one or more third parties. 1.11 "DEVELOPMENT PLAN" shall mean the Product Development Plan pursuant to Section 6.3 (A) as the same may be modified from time to time pursuant to Section 6.3 (B). The plan will include all development activities including, but not limited to, ***. 1.12 "EFFECTIVE DATE" shall mean the date set forth on the first page of this Agreement. 1.13 "EMEA" shall mean European Medicines Evaluation Agency or any successor agency thereto. 1.14 "FULLY-BURDENED DEVELOPMENT COST" shall have the meaning set forth in Appendix B attached hereto and made a part hereof. 1.15 "FULLY-BURDENED MANUFACTURING COST" shall have the meaning set forth in Appendix C attached hereto and made a part hereof. 1.16 "INITIAL COMMERCIAL SALE" shall mean the first commercial sale by Abbott, or any Abbott Affiliate of Product to any third party customer. 1.17 "INTERIM PRODUCT" shall mean the Substance formulated, filled and packaged for development studies by LJP or its approved subcontractors. 4 5 1.18 "LJP COMPOSITION PATENTS" shall mean (A) the LJP Patents (as defined below) identified as LJP Composition Patents in Part I of Appendix D attached hereto and made a part hereof (including any divisions, continuations, continuations-in-part, reexaminations, reissues, additions, renewals and extensions thereof), (B) any LJP Patents issued at any time during the Term from LJP Patent Applications (as defined below) identified as LJP Compositions Patent Applications in Part II of Appendix D (including any divisions, continuations, continuations-in-part, reexaminations, reissues, additions, renewals and extensions thereof) and (C) any composition of matter patents of LJP and its Affiliates in the Territory issued at any time during the Term that claim the priority of a United States LJP Composition Patent (including any divisions, continuations, continuations-in-part, reexaminations, reissues, additions, renewals and extensions thereof). 1.19 "LJP MANUFACTURING KNOW-HOW" shall mean all non-patented and unpublished documentation, information, and data relating to the formulation, manufacture and/or quality control of the Substance or the Interim Product owned or controlled by LJP and its Affiliates which LJP is not prohibited from disclosing as of the Effective Date or at any time during the Term. 1.20 "LJP NON-MANUFACTURING KNOW-HOW" shall mean any non-patented and unpublished nonclinical, preclinical and clinical documentation, information and data relating to the Substance or the Interim Product owned or controlled by LJP and its Affiliates, which LJP is not prohibited from disclosing as of the Effective Date or at anytime during the Term, including but not limited to, documentation, information and data pertaining to development, Regulatory Approval, quality control, quality assurance, formulation, marketing or sales of the Substance, Interim Product or Product. 1.21 "LJP PATENTS" shall mean the LJP patents identified in Part I of Appendix D attached hereto and made a part hereof and all other issued patents of LJP and its Affiliates in the Territory as of the Effective Date and other patents of LJP and its Affiliates in the Territory issued at any time during the Term that in each case would be infringed by the use, manufacture, having manufactured, importation, offer for sale or sale or development of the Substance or Product in the Territory (including any divisions, continuations, continuations-in-part, reexaminations, reissues, additions, renewals and extensions thereof). It is understood and agreed that where an LJP patent as described above contains multiple claims, such patent shall be considered an LJP Patent only with respect to the claims that would be 5 6 infringed by the use, manufacture, having manufactured, importation, offer for sale, sale or development of the Substance (including as an element of the Product) in the Territory , and LJP shall retain all right, title and interest in and to the remaining claims of any such patent, free and clear of any rights on the part of Abbott. LJP Patents in existence as of the Effective Date are set forth in Part I of Appendix D and such Appendix shall be amended by LJP from time to time during the Term to include future LJP Patents issuing from LJP Patent Applications. 1.22 "LJP PATENT APPLICATIONS" shall mean the LJP patent applications identified in Part II of Appendix D and all other patent applications of LJP and its Affiliates in the Territory as of the Effective Date and other patent applications of LJP and its Affiliates in the Territory filed at any time during the Term that could issue patents that, in each case would be infringed by the use, manufacture, having manufactured, importation, offer for sale, sale or development of the Substance or Product in the Territory including any divisions, continuations, continuations-in-part, reexaminations, reissues, additions, renewals and extensions thereof. LJP Patent Applications in existence as of the Effective Date are set forth in Part II of Appendix D, and such Appendix shall be amended by LJP from time to time during the Term to include future LJP Patent Applications. It is understood and agreed that where an LJP patent or patent application as describe above contains multiple claims, such patent or patent application shall be considered an LJP Patent or LJP Patent Application only with respect to the claims that would be infringed by the use, manufacture, having 6 7 manufactured, importation, offer for sale, sale or development of the Substance (including as an element of the Product) in the Territory, and LJP shall retain all right, title and interest in and to the remaining claims of any such patent or patent application, free and clear of any rights on the part of Abbott. 1.23 "LJP PATENT RIGHTS" shall mean LJP Patents and LJP Patent Applications. 1.24 "MAJOR COUNTRIES" shall mean the following countries individually or collectively, as applicable: France, Germany, Spain, the United Kingdom, Italy. 1.25 "MANUFACTURING SCALE-UP" shall mean: the definition as provided in Appendix, B. 1.26 "MANUFACTURING PLAN" shall mean the manufacturing plan as defined in Section 3 of the Supply Agreement, Appendix G. 1.27 "NET SALES" shall mean (A) With respect to the Product sold alone, the gross sales of the Product in the Territory by Abbott, and its Affiliates to unrelated third party customers (as defined below) to any national or local governments, hospitals, drug wholesalers, pharmacies, and other third party customers (such as distributors, agents, or Unaffiliated Sublicensees, surgicenters and other institutions, the primary business of which is providing medical care), which are not (except as otherwise provided in Section 4.5) Abbott Affiliates, less the following deductions ("Deductions"): ***. 7 8 (B) With respect to a Combination Product, the gross sales of such Combination Product in the Territory by Abbott and its Affiliates to unrelated third party customers except as otherwise provided in Section 4.5 less the Deductions referenced in (A) above, multiplied by a fraction ***. The royalty paid to LJP on the Combination Product will not be less than the royalty paid to LJP on the Product sold alone. *** Notwithstanding the foregoing, in no event shall the amount computed in accordance with the first sentence of this clause (B) be less than ***. 8 9 (C) With respect to the product when it is sold in a Premium Delivery System (as defined below), an amount equal to ***. As used herein, "Premium Delivery System" means a drug delivery system which comprises *** An example calculation is provided in Appendix I. 1.28 "PARTY" (and "PARTIES") shall mean either LJP or Abbott (or both), as the context requires. 1.29 "PRODUCT(S)" shall mean formulated, filled and packaged pharmaceutical compositions and dosage units and the like containing the Substance. 1.30 "REGULATORY APPROVAL" shall mean all governmental approvals required to market and sell the Product in any given country in the Territory, including but not 9 10 limited to, product registrations, medical approvals, and price and marketing approvals. Such approvals must be based upon (i) LJP or any LJP Affiliates or approved subcontractors as an approved manufacturer of the Substance at LJP's or any LJP Affiliates' or approved subcontractor's manufacturing facilities and (ii) to the extent required by applicable laws and regulations such approvals must be based upon approval of Abbott with respect to Abbott's finished Product filling, packaging and labeling facilities pursuant to the Supply Agreement, Appendix G. 1.31 "RENAL CARE" shall mean the field of care covering products ***. 1.32 "SPECIFICATIONS" shall mean the quality and other specifications for the Substance and the Interim Product to be manufactured by LJP or its Affiliates or approved subcontractors for supply to Abbott, its Affiliates and Unaffiliated Sublicensees, which Specifications shall comply with applicable regulatory requirements and shall be based upon LJP's current specifications for the Substance and the Interim Product included with LJP's U.S. IND (as defined below). A copy of such current specifications is set forth in Appendix E attached hereto and made a part hereof. Such Specifications shall be agreed upon by the Parties in writing as soon as practicable after the Effective Date, but in no event later than six (6) months thereafter, and may be amended from time to time during the Term by written agreement of the Parties. 1.33 "STOCK PURCHASE AGREEMENT" shall mean that certain Stock Purchase Agreement between the Parties bearing even date herewith under which Abbott shall purchase certain LJP common stock as described therein. 10 11 1.34 "SUBSTANCE" shall mean LJP 394 as defined in Appendix A to this Agreement, in bulk drug form. 1.35 "TERM" shall mean the period commencing on the Effective Date and continuing until ***. 1.36 "TERRITORY" shall mean all countries, territories and other areas of the world. 1.37 "UNAFFILIATED SUBLICENSEE" shall mean any sublicensee of Abbott under this Agreement other than an Abbott Affiliate. 1.38 "U.S. FDA" shall mean the United States Food and Drug Administration and any successor regulatory agency. 1.39 "U.S. FD&C ACT" shall mean the United States Food, Drug and Cosmetic Act, including any amendments thereto and all regulations promulgated thereunder. 1.40 "U.S. IND" shall mean an Investigational New Drug Application filed with the U.S. FDA. 1.41 "U.S. NDA" shall mean a New Drug Application filed with the U.S. FDA. 1.42 "VALID CLAIM" shall mean one (1) or more claims of an issued and unexpired LJP Patent which neither has been held unenforceable, unpatentable or invalid by a decision of a court or governmental agency of competent jurisdiction, unappealable or unappealed within the time allowed for appeal, nor has been admitted 11 12 by the holder of the LJP Patent to be invalid or unenforceable through reissue, disclaimer, abandonment or otherwise. ARTICLE II GRANT AND SCOPE OF RIGHTS GRANTED 2.1 License Rights Granted - LJP hereby grants to Abbott and Abbott Affiliates an exclusive license under LJP Patent Rights and LJP Non Manufacturing Know-How to use, import, offer for sale, and sell the Product in the Territory, which license shall be exclusive even as to LJP and its Affiliates, except as provided in Section 2.2. LJP also hereby grants to Abbott and Abbott Affiliates a non-exclusive, limited license under LJP Patent Rights and LJP Manufacturing Know-How to make and have made the Substance and Product in the Territory, solely in accordance with Article XIV, and Appendix G (Supply Agreement). 2.2 Manufacturing and Use Rights Reserved - Except as otherwise provided in Article XIV and Appendix G (Supply Agreement), LJP retains the exclusive right to manufacture or have manufactured the Substance, provided that Abbott and its Affiliates shall have the right during the Term to use Substance supplied by LJP hereunder ***. Notwithstanding Section 2.1, LJP retains the right to use, but not market or sell the Substance, the Interim Product and the Product and practice the LJP Patents to develop any product or to develop any product or compound, including (without limitation) any Back-Up Compounds subject to Sections 2.5 and 12.1. 2.3 Use of LJP Non-Manufacturing Know-How and LJP Manufacturing Know-How - Under the license granted pursuant to Section 2.1, Abbott shall have the right to use and reference LJP Non-Manufacturing Know-How provided to Abbott by LJP in 12 13 support of ***. Under the license granted pursuant to Section 2.1, Abbott may use LJP Manufacturing Know-How only upon receipt thereof in accordance with Article XIV below and solely for the manufacture of the Substance and the Product only to the extent authorized under Article XIV. Abbott shall limit access to LJP Non-Manufacturing Know-How and LJP Manufacturing Know-How to those Abbott personnel with a need to know at the time of disclosure to such personnel, and such access shall be limited to the duration of such need to know. Subject to the license rights granted hereunder, LJP retains all ownership rights to all LJP Patent Rights, LJP Non-Manufacturing Know-How and LJP Manufacturing Know-How. 2.4 Sub-licensing - Abbott shall have the right to sublicense its rights under this Agreement to Unaffiliated Sublicensees, provided that Abbott has obtained LJP's prior written consent on a case-by-case basis, which consent shall not be unreasonably withheld, and that such sub-licensing of Abbott's rights shall not relieve Abbott of any obligations hereunder, including obligations hereunder relating to the activities of its Unaffiliated Sublicensees. 2.5 Back up Compounds - During the Term, Abbott shall also have the right to exclusively license from LJP and develop with LJP, Back up Compounds ***. LJP shall give Abbott prompt written notice of any such Back up Compounds when nominated for preclinical development. Abbott shall have *** from receipt of such notice to give LJP written notice of Abbott's intention to negotiate with LJP for rights to such Back up Compound. 2.6 Other Compounds - During the Term, Abbott shall also have the right of first negotiation to exclusively license compounds ***. 13 14 LJP shall give Abbott prompt written notice of any such compounds when nominated for preclinical development. *** 2.7 No Implied Licenses - Any rights not expressly granted by either Party to the other Party in this Agreement are expressly reserved by the Party owning or controlling such rights and, accordingly, no licenses other than those specified herein shall be deemed granted by this Agreement by implication, estoppel or otherwise. 2.8 Affiliate Performance: Abbott hereby guarantees the performance of its Affiliates of all Abbott obligations under this Agreement. ARTICLE III MILESTONE PAYMENTS 3.1 Payments - In consideration of LJP's entering into this Agreement and the rights and licenses granted to Abbott hereunder, during the Term Abbott shall pay LJP milestone payments according to the following payment schedule, consisting of the following milestone payments: (1) Effective Date - Within ten (10) business days after the Effective Date, Abbott shall pay LJP Four Million Dollars ($4,000,000). 14 15 (2) *** (3) *** (4) *** (5) *** 15 16 (a) *** (b) *** (c) *** 3.2 No Refundability - All milestone payments which Abbott is required to make to LJP pursuant to Section 3.1 shall become payable upon the occurrence of the applicable event, and shall be non-refundable once paid. However, if this Agreement is terminated for any reason prior to a given milestone payment becoming due or if the events specified for a given milestone payment do not occur, then Abbott shall have no obligation to make such milestone payment. ARTICLE IV ROYALTY RATES AND INCENTIVE PAYMENTS 4.1 Royalty Rates - in further consideration of the rights and licenses granted to Abbott hereunder, Abbott shall pay LJP royalties at the rates set forth below: 16 17 (A) The royalties shall apply on a country-by-country basis (i) *** from Initial Commercial Sale in a Major Country or the United States or (ii) ***, or (iii) ***. (B) Countries without Competition - Abbott shall pay LJP an annual royalty ("Full Royalty") calculated on the total worldwide aggregate Annual Net Sales in the Territory excluding Net Sales in any country in which royalties are no longer payable pursuant to Section 4.1 (A) during the time in which no Competition exists in a particular country as follows: (1) on the portion less than *** (2) on the portion between *** (3) on the portion between ***; and (4) on the portion greater than ***. (C) Countries With Competition - In countries where Competition exists, the "Full Royalty" shall be reduced, but only for so long as such Competition exists, in a manner reflective of ***. Royalties shall be payable at the Full Royalty rate until *** 17 18 Any adjustments to the Full Royalty rate based on the existence of Competition shall be calculated in accordance with the following formula: (1) where Abbott's market share is *** than Abbott's market share prior to the existence of Competition, the royalty shall be *** of the applicable Full Royalty 18 19 (2) where Abbott's market share is *** of Abbott's market share prior to the existence of Competition, the royalty shall be *** of the applicable Full Royalty; (3) where Abbott's market share is *** of Abbott's market share prior to the existence of Competition, the reduced royalty shall be *** of the applicable Full Royalty; (4) where Abbott's market share is *** of Abbott's market share prior to the existence of Competition, the royalty shall be *** of the applicable Full Royalty, and (5) where Abbott's market share is less than *** of Abbott's market share prior to the existence of Competition, the reduced royalty shall be *** of the applicable Full Royalty. *** Total worldwide aggregate Annual Net Sales figure shall determine the applicable Full Royalty rate. The applicable Full Royalty rate shall then be applied to Annual Net Sales in a particular country on a country-by-country basis in accordance with the level of patent protection and Competition set forth above. (D) Royalty Calculation Example for Countries without Competition For illustration purposes, in a calendar year when Annual Net Sales in the entire Territory are ***, the aggregate total royalty to LJP for countries without Competition would be ***, calculated as follows: 19 20 *** x *** = *** *** x *** = *** *** x *** = *** *** x *** = *** --- --- *** *** (E) Royalty Calculation Example for Countries with Competition For illustration purposes, in a calendar year when Annual Net Sales in the entire Territory are ***, the aggregate total royalty to LJP for countries without Competition would be ***, calculated as follows: *** x *** = *** *** x *** = *** *** x *** = *** *** x *** = *** --- --- *** *** Average Royalty Rate *** Royalty adjustments shall be made by Abbott on a country-by-country basis using the average royalty rate reduced by the Abbott's local market share as follows: 20 21 Sales in Countries with Competition *** Applicable Full Royalty Rate *** Royalty Due Before Adjustments *** Market Share Adjustment Royalty Due *** *** *** 4.2 Incentive Payments - (A) Incentive Payments Schedule - Abbott also shall pay LJP the following one time only sales incentive payments for the first year during the Term in which total worldwide aggregate Annual Net Sales achieve each of the following milestone levels: MILESTONE LEVEL INCENTIVE PAYMENT Upon reaching Annual Net *** Sales levels of *** Upon reaching Annual Net *** Sales levels of *** Upon reaching Annual Net *** Sales levels of *** 21 22 Upon reaching Annual Net *** Sales levels of *** Upon reaching Annual Net *** Sales levels of *** TOTAL *** Abbott shall make incentive payments within thirty (30) days of the end of the Calendar Quarter in which the applicable milestone level is achieved. (B) Incentive Payments Example For illustration purposes, one time incentive payments shall be paid for the calendar year in which the total worldwide aggregate Annual Net Sales achieve the designated milestone levels as shown below:
Year Yr. 1 Yr.2 Yr. 3 Yr. 4 Yr. 5 Yr. 6 Yr. 7 ----- ---- ----- ----- ----- ----- ----- Annual Net Sales ($MM) *** *** *** *** *** *** *** One Time Incentive Payments ($MM) *** *** *** *** *** *** ***
4.3 Royalty Reports and Payments - Commencing with the first Calendar Quarter in which Abbott, and its Affiliates make the Initial Commercial Sale, Abbott shall provide LJP with a written report of Net Sales on a country-by-country basis within *** after the last day of March, June, September and December for royalties accruing on Net Sales in the United States during the *** preceding calendar months and within *** after the last day of February, May, August and 22 23 November for royalties accruing on Net Sales in the Territory outside of the United States during the *** preceding calendar months. Concurrently with the submission of each such written report, Abbott shall pay or cause to be paid to LJP the total amount of royalties shown to be due thereon. In addition, Abbott shall provide LJP with a total worldwide monthly preliminary sales estimate for Product within *** after the last day of each ***. 4.4 Currency- Abbott shall make all royalty and cost of goods payments to LJP pursuant to Section 4.3 and all other payments due hereunder in U.S. Dollars. Royalty and cost of goods and other payments earned shall be first determined by Abbott in the currency of the country where the Net Sales were made and then converted by Abbott directly to its equivalent in U.S. Dollars. The rates of exchange for converting the currencies involved to U.S. Dollars as quoted by the Wall Street Journal (Midwest Edition) as Foreign Exchange Rates quoted in New York as market rate (bid) on the last business day of the quarterly period in which the royalty and cost of goods payments were earned shall be used by Abbott to determine such conversion rates. 4.5 No Royalties Payable Between Affiliates - No royalties shall be payable to LJP on sales between Abbott and its Affiliates or between Abbott Affiliates unless the purchaser is the end user of the Product, in which case royalties shall be payable as provided above. 4.6 No Multiple Royalties - No multiple royalties shall be payable because the Product, its manufacture, use, import, offer for sale or sale is or shall be covered by multiple LJP Patents. ARTICLE V PAYMENT, RECORD KEEPING AND AUDIT RIGHTS 5.1 Method of Payment - All payments by either Party to the other Party hereunder (including, but not limited to, Abbott's milestone and incentive payments 23 24 under Sections 3.1 and 4.2 and royalty and costs of goods payments under Section 4.1 and Sections 6.2, 6.3, and 6.4 of Appendix G.) shall be made in U.S. Dollars and without deduction of any withholdings for any purposes other than taxes, if applicable, to the extent required by law. In the event of any tax withholding, the paying Party will provide the receiving Party with any relevant certificates or documents required for national, state or local tax credit and reporting purposes. Payments hereunder shall not be creditable against any other amounts payable by the other Party under this Agreement. Payments to LJP shall be made by wire transfer to LJP's bank as follows: *** Abbott shall provide LJP with appropriate wire transfer instructions for payments to Abbott. Either Party may change wire instructions for payments to that Party upon written notice to the other Party. 5.2 Record Keeping and Audit Rights - Each Party shall keep or cause to be kept accurate records relating to Net Sales, royalties, Fully Burdened Development Costs, Fully-Burdened Manufacturing Costs, and any other costs and expenses subject to payment or reimbursement by either Party to the other Party in sufficient detail to enable the amounts payable hereunder to be determined. Upon the written request of either Party (but not more frequently than once in any calendar year), the requesting Party may retain a nationally-recognized, independent certified public accountant, 24 25 subject to written approval by the other Party (which approval shall not be unreasonably withheld), to review such records to verify the accuracy of the payments made or payable hereunder. Such accountant shall be required to execute a confidentiality agreement in a form reasonably acceptable to the audited Party and shall report to the auditing Party only the amount of any underpayment or overcharge. Within *** after completion of such review, the Parties shall reconcile any underpayment or overcharge. The auditing Party shall pay the cost of any review of records conducted at its request under this Section . However, if the review establishes underpayment or overcharge by the audited Party of over *** during the period of the review, the audited Party shall promptly reimburse the auditing Party for the fees and expenses of the accountant. Such audit rights shall survive termination or expiration of this Agreement, but may be exercised by the Parties only with respect to records for the current calendar year and the preceding ***. ARTICLE VI PRODUCT DEVELOPMENT AND REGISTRATIONS 6.1 Development and Registration Activities (A) Abbott Activities - In accordance with the Development Plan, Abbott shall undertake development and registration activities for the Product in the Territory, including but not limited to conducting or having conducted, and completing or having completed, all clinical studies and other activities required for Regulatory Approvals under the Development Plan. Abbott shall use Commercially Reasonable Efforts to pursue such development and registration activities under the Development Plan with the objective of filing applications for Regulatory Approval throughout the Territory. Abbott's Regulatory Approvals in the Territory shall be owned solely by Abbott. 25 26 (B) LJP Access to Data - Abbott shall provide LJP, within a reasonable time, with access to information and data reasonably requested by LJP relating to Abbott's development and registration activities, including but not limited to, medical and statistical study reports for individual studies, clinical data summaries, and expert reports, but excluding Product registration packages and registrations. (C) LJP Activities - Pursuant to the Development Plan, LJP shall use Commercially Reasonable Efforts to assist Abbott in performing development and registration activities for the Product in the Territory. (D) Health registrations - Abbott shall use Commercially Reasonable Efforts to obtain all necessary Regulatory Approvals in the Territory taking into account the relative importance of the individual markets on a per country basis. Abbott and LJP shall keep each other informed concerning regulatory filings for the Product. The parties agree that they will work together to minimize regulatory issues that may become problems for one another. Abbott and LJP also agree to keep one another fully informed of changes in the manufacture of Substance or Products that may create regulatory issues for one another and will work with one anther to minimize these issues. Abbott further agrees to use its Commercially Reasonable Efforts to file for all Regulatory Approvals in the United States and Major Countries for Products within *** from the Effective Date. (E) Decision on United States/European Clinical Trials - Within *** of the availability of the final Abbott approved scientific report from the 90-05 study, and any other United States or European major clinical study, Abbott will inform LJP whether it has decided to file for Regulatory Approval, initiate additional studies or terminate the Agreement pursuant to Section 19.4(C) or take other action after review with LJP, provided that any other actions shall be mutually agreed upon. 26 27 6.2 Development Costs - Commencing as of January 1, 1997 and continuing for the remainder of the Term, Abbott shall bear the costs and expenses related to clinical development for the Product, including toxicology, carcinogenicity, process development, registration and regulatory activities, including costs of filing, obtaining and maintaining all Regulatory Approvals throughout the Territory, including existing obligations, such as the LJP 90-05 Study. Abbott will transfer funds to LJP at LJP's Fully Burdened Development Cost as defined in Appendix B, and excluding the activities being directly funded by Abbott. Abbott will transfer these funds, as needed, at least *** in advance, on a monthly rolling basis for each subsequent time period based on the approved budget, except for the first payment, which shall be due on *** upon completion of the Development Plan for the first Calendar Quarter. LJP shall bear the cost of providing manufacturing capacity and Manufacturing Scale Up subject to Appendix B and the Supply Agreement, Appendix G. 6.3 Development Plan (A) Completion of Development Plan - The Parties shall in good faith agree upon and complete the Development Plan within *** days after the Effective Date. The Development Plan shall cover the detailed plans for various studies including costs, timing, data management, adverse event reporting, etc., as well as include language concerning diligence, delays and remedies for potential problems. *** 27 28 (B) Changes - The Parties recognize that LJP has developed a level of clinical development capability, expertise and staffing and that it is LJP's intention to maintain a clinical development team and it is Abbott's intention to access the capabilities of this team in support of development of the Product. Abbott may make any changes to the Development Plan as Abbott deems necessary or appropriate, provided that Abbott will not, if at all practical, adversely impact LJP clinical development capability and shall give due consideration to the intentions of the Parties under the preceding sentence and that LJP has been given a reasonable opportunity to review and consult with Abbott as to any such changes. 6.4 Executive Committee and Development Team (A) Within *** of the Effective Date, the Parties shall form an executive committee ("Committee"), which shall be primarily responsible to ***. The Committee shall consist of *** members from Abbott and *** members from LJP. Each Party shall notify the other Party in writing of its designated members and any replacements. (B) The Parties shall also appoint a project team ("Development Team") to ***. The Development Team shall report to the Committee on the progress of the Development Plan on a *** basis. (C) The Parties shall also designate a key contact person at each company who will be responsible for managing all communications between the Parties. 6.5 Development Team Responsibilities (A) As part of its responsibilities, the Development Team shall 28 29 (1) ***; (2) ***; (3) ***; (4) ***. The Party hosting each meeting of the Development Team promptly shall prepare, and deliver to the other Party within *** after the date of such meeting, minutes of such meeting setting forth all decisions of the Development Team relating to the Development Plan in a form and content reasonably acceptable to the other Party. (B) The Development Team shall meet at least once every *** during the term of the development of the Product(s), at such times and places as agreed to by LJP and Abbott, alternating between San Diego and Abbott Park, or such other locations as the parties shall agree. Meetings of the Development Team may be attended by such other directors, officers, employees, consultants and other agents of LJP and Abbott as the Parties from time to time reasonably agree. 6.6 Research and Development Budget (A) The Development Team shall be responsible for reviewing and proposing timelines for research and development activities as well as an annual research and development budget ("Annual R&D Budget"). The Parties shall prepare general timelines and detailed budget estimates for all research and development activities as part of the Development Plan. In addition, the Development Plan shall also contain the agreed upon Annual R&D Budget for 1997. Within *** of the 29 30 Effective Date, the Development Team will prepare a detailed budget for 1997 ***. (B) For 1998 and every year of the Development Plan thereafter, the Development Team shall propose an Annual R&D Budget to the Committee for approval by *** of the preceding year. On or before *** of the preceding year, the Committee shall review the Development Team's proposed Annual R&D Budget and submit it, together with any recommended changes for Abbott's final review and approval. (C) The Development Team may propose adjustments to the Annual R&D Budget up to two (2) times per year, using the same mechanism referenced above in (B) for the initial Annual R&D Budget, in accordance with the following time frames:
Development Team Committee Review Proposes and Proposes Abbott Approves ---------------- ---------------- --------------- 1. *** *** *** 2. *** *** ***
(D) Subject to Abbott's obligations under Sections 6.1A Abbott shall have the ultimate right to approve the Annual R&D Budget (and any adjustments thereto) for each year during the Development Plan. 6.7 LJP Documentation and Data (A) LJP Non-Manufacturing Know-How - As soon as practicable after the Effective Date, but in no event later than *** thereafter, LJP shall provide Abbott with the LJP Non-Manufacturing Know-How, primarily the data included in LJP's United States IND, and all other documentation, information and data listed 30 31 or referenced in the Development Plan, but not LJP Manufacturing Know-How and Abbott shall be authorized to use and reference the same solely as provided in Section 2.3 above. Any Product Drug Master Files ("DMFs") compiled or owned by LJP shall remain the property of LJP, but LJP shall provide appropriate authorization letters to relevant regulatory bodies in the Territory within *** after the Effective Date to enable Abbott to reference such DMFs for purposes of Abbott's applications for Regulatory Approval and regulatory compliance activities in the Territory. At Abbott's option, LJP shall also take all actions necessary or appropriate to transfer the sponsor obligation for the U.S. IND and equivalent regulatory filings for the Product in the Territory to Abbott within *** after the Effective Date. Abbott agrees not to access the proprietary information in the CMC section of the existing or previous INDs, except as provided in Article XIV but will be able to access the non-proprietary CMC sections which LJP shall supply to Abbott. If Abbott requests LJP to transfer the sponsor obligation to Abbott, LJP shall create a DMF for the proprietary section information and file the DMF and provide Abbott the DMF's reference number. At Abbott's option, Abbott may require LJP to support the U.S. IND and file the U.S. NDA with the FDA. Abbott shall still maintain all responsibility and control of this NDA filing, subject to Sections 6.1A and 6.1D. (B) Abbott Access to Data - During the Term, LJP shall provide Abbott, within a reasonable time, with access to all clinical documentation, information and data resulting from LJP's Product research and development activities in the Territory which Abbott requires for regulatory filings in the Territory or which Abbott may reasonably request, including but not limited to, case report forms, monitoring documents, patient informed consents, institutional review board approvals, medical and statistical study reports for individual studies, clinical data summaries, and expert reports. Upon Abbott's request, LJP shall provide Abbott with copies of such documentation and data. 31 32 (C) Information and Documentation for LJP Patent Extensions - Abbott shall notify and provide to LJP, within *** after each Regulatory Approval in the Territory has been received in writing by Abbott, written confirmation of such Regulatory Approval to enable LJP to fulfill its obligations with respect to seeking LJP Patent extensions pursuant to Section 11.1. Abbott, shall also provide to LJP any other documentation required by the relevant patent authorities, as requested by LJP, as soon as practical. ARTICLE VII PRODUCT MARKETING AND SALES ACTIVITIES 7.1 Product Launch - Abbott shall use Commercially Reasonable Efforts to launch the Product or cause the Product to be launched as soon as practical in every country of the Territory where Abbott or its Affiliates or Unaffiliated Sublicensees have obtained Regulatory Approval. Notwithstanding the foregoing, Abbott may, acting in good faith in the exercise of its reasonable business judgment, determine either to delay the launch of the Product or not to launch the Product in any given country of the Territory, which decision shall not be deemed a failure by Abbott to use Commercially Reasonable Efforts in such country and also shall not be deemed an abandonment of Abbott's rights in such country. If Abbott or its Affiliates or Unaffiliated Sublicensees delay the launch of the Product in any country for more than *** after Abbott or its Affiliates or Unaffiliated Sublicensees have obtained Regulatory Approval in such country, LJP may commence dispute resolution proceedings against Abbott pursuant to Article XXIV and Abbott shall have the burden of proving that such delay was attributable to bona fide business reasons affecting the Product. 7.2 Abbott Sales and Marketing Activities - During the period commencing with Regulatory Approval in each country of the Territory on a country-by-country basis and for the remainder of the Term, Abbott shall use Commercially Reasonable Efforts to promote, market and sell the Product in the Territory. 32 33 7.3 Marketing Costs and Expenses - Except as provided in Section 7.4 and as otherwise agreed in writing by the Parties, Abbott shall bear all costs and expenses related to sales and marketing activities for the Product under this Agreement. 7.4 Cooperative Marketing Activities (A) LJP, at its option and its own expense, may hire marketing support specialists to assist Abbott in educating the rheumatologists, in their offices in the U.S. All activities will be coordinated with Abbott and agreed by the Parties in writing. All educational and promotional material must have Abbott medical, regulatory, and commercial approval and comply with all regulatory filings, approvals and requirements. (B) Abbott will be solely responsible for calls on nephrologists, managed care, integrated systems, family practitioners, and the acute hospital setting. 7.5 Marketing Review Meetings - At least once each *** after Abbott's first Regulatory Approval, for a period of *** thereafter, and at least once each *** after such *** period, representatives of the Parties shall review Abbott sales and marketing activities and LJP cooperative activities. 7.6 Export Control Laws - Abbott shall comply with all applicable export laws and restrictions and regulations of the Department of Commerce or other United States or foreign agency or authority, shall not export, or allow the export or re-export of any Confidential Information or Products or any direct product thereof in violations of any such restrictions, laws or regulations or, without obtaining all necessary approvals and authorizations if any, to Afghanistan, the People's Republic of China or any Group Q, S, W, Y or Z country specified in the then current Supplement No. 1 to Section 770 of the U.S. Export Administration Regulations or any successor supplement or regulations); 33 34 Abbott shall obtain and bear all expenses relating to any necessary licenses and/or exemptions with respect to the export from the U.S. of all material or items deliverable by LJP to any location and shall at LJP's request demonstrate to LJP compliance with all applicable laws and regulations prior to delivery thereof by LJP. 7.7 Abbott Product Claims - Abbott shall only make claims, representations or warranties directly or indirectly to any third party about the Product that are consistent with the Product's Regulatory Approvals and other scientific literature. 7.8 Sample Distribution - Abbott shall be solely responsible for complying with all laws and regulations related to the distribution of samples of Products in any part of the Territory. Any fines and/or penalties for failure by Abbott to comply with any requirement or regulation shall be the sole responsibility of Abbott ARTICLE VIII CONFIDENTIALITY AND PUBLICITY 8.1 Confidentiality Obligation - Each Party shall hold the other Party's Confidential Information (as defined below) of which it becomes informed in connection with this Agreement in strictest confidence and shall not disclose such Confidential Information to third parties or otherwise use it, except to the extent such use or disclosure is expressly permitted by the terms of this Agreement or is reasonably necessary for the performance of this Agreement. 8.2 Permitted Disclosures - Permitted disclosures of Confidential Information hereunder include, but are not limited to: (A) disclosures to regulatory agencies to the extent required for Regulatory Approval, including but not limited to, Abbott Product registrations and applications in the Territory and (B) disclosures to the Parties' Affiliates, employees, agents and independent approved subcontractors (including clinical investigators, consultants and contract research organizations) who have a bonafide "need to know," and Unaffiliated Sublicensees (in the case of Abbott), 34 35 provided that for disclosures to parties other than Affiliates the disclosing Party shall obligate the recipients to maintain the confidentiality of Confidential Information under terms substantially similar to those contained in this Article VIII. 8.3 Confidential Information - "Confidential Information" includes, but is not limited to, any information relating to the terms of this Agreement, the Product, LJP Non-Manufacturing Know-How, LJP Manufacturing Know-How, the Development Plan, Abbott Regulatory Know-How, clinical and non-clinical studies involving the Product, and all sales and marketing plans for the Product, as well as information concerning all other products and the business affairs, manufacturing processes and other activities of the disclosing Party that are designated as confidential in writing or orally disclosed, provided such oral disclosure is confirmed as confidential in writing within thirty (30) days thereafter. However, Confidential Information shall not include any information: (A) Publicly Available Information - Which at the time of disclosure is or later comes into public domain by publication or otherwise through no fault of the receiving Party; (B) Previously Known Information - Which can be demonstrated by documentation or other competent proof to have been in the receiving Party's possession prior to disclosure hereunder; (C) Subsequently Received Information - Which is subsequently received by the receiving Party from a third party who is not bound by any confidentiality undertaking to the disclosing Party or to any of its Affiliates with respect to said information; (D) Independently Developed Information - Which can be demonstrated by documentation or other competent proof to have been independently 35 36 developed by or for the receiving Party without reference to the disclosing Party's Confidential Information, or (E) Legally Required Disclosures of Information - Which is legally required to be disclosed pursuant to any statute or regulation or any judicial or administrative order. 8.4 Duration of Confidentiality Obligation - The confidentiality obligations of the Parties hereunder shall remain in effect during the Term and for *** thereafter. 8.5 Publicity and Announcements - It is recognized by the Parties that LJP may under certain circumstances need to disclose development and commercialization activities and Abbott will not unreasonably withhold its approval and support of the LJP development and commercial activities necessary to generate and disclose this information. Unless agreed upon in writing by the Parties, neither Party shall originate any publicity, news release or other public announcement, written or oral, whether to the public press, stockholders or otherwise, relating to this Agreement, any amendment hereto, performance by the Parties hereunder, or the Product, except where a Party believes in good faith that disclosure is required or advisable under applicable laws or regulations in which event such Party shall give the other Party *** to review the form and content of any written announcement before such legally required or advisable disclosure is made. Except for customary discussions with current or prospective investors and analysts, or at securities, industry, scientific, or similar 36 37 conferences or as required or advisable under applicable laws or regulations, each Party shall give the other Party a reasonable opportunity (not to exceed ***) to review the content of any oral announcement before it is made. Notwithstanding the foregoing, however, where urgent, unusual and rare circumstances required immediate disclosure in the opinion of the Parties' counsel, the Parties shall use their best efforts to provide advanced notice to each other, but the *** notice requirement shall not apply. 8.6 Scientific Media Plan and Publication - Abbott shall develop a media strategy for the Product and shall consult with LJP for its input. The objective of the media strategy shall be to detail the publication of the Product's clinical data and to present the clinical data at the appropriate marketing meetings/targets. The media strategy shall focus on primary presentations and journal submissions of the clinical and preclinical studies of the Product to be submitted as part of the U.S. NDA. Specific end point for media targets shall be defined so that abstract and manuscript concepts may be developed and authors determined. LJP and Abbott employees may be considered as authors in addition to investigators and outside experts. Abbott shall have the responsibility to maintain and update the media strategy. Abbott shall consult with LJP, but Abbott shall have the final responsibility, except in the 90 - 05 study, where the authorship mechanism has already been defined, to assign authors, draft publications, and submit to journals. Following the Effective Date, LJP shall not submit scientific publications on the Substance or the Product without Abbott's prior written approval within ***, which approval shall not be unreasonably withheld. 37 38 ARTICLE IX TRADEMARKS 9.1 Abbott Trademarks - Abbott and its Affiliates shall market and sell the Product in the Territory under Abbott Trademarks to be selected and owned by Abbott and its Affiliates. Abbott and its Affiliates shall, at its expense, file applications for registration, prosecute and maintain the Abbott Trademarks. 9.2 Use of LJP Trademarks and LJP Tradedress - At each Party's option, the Products may bear the tradedresses of Abbott and LJP wherever possible. The name of LJP as manufacturer will appear on the Product's package label and insert. LJP's name as a manufacturer will appear on certain promotion materials, except where prohibited by law or regulation. Abbott shall have a royalty free license to use those LJP technology related trademarks that LJP uses or intends to use with products. If Abbott abandons a market, or the Agreement is terminated in its entirety or in any country, except by Abbott under Section 19.2 for breach by LJP, LJP shall have the option to obtain a royalty bearing license on the Abbott Trademark, for use exclusively with the Product upon reasonable terms to be negotiated and if LJP so elects, then LJP shall pay the applicable maintenance fees and enforcement costs. 38 39 9.3 No Inconsistent Actions - Neither Party shall take any actions inconsistent with the other Party's ownership of such other Party's trademarks, trade names, logos or the like, including (without limitation) by registering or attempting to register the same. Neither Party shall use any trademarks, trade names, logos or the like that are confusingly similar to the trademarks, trade names, logos or the like of the other Party for any Product. Each Party shall obtain the prior written consent of the other Party, not to be unreasonably withheld or delayed, to such Party's manner of using the other Party's trademarks, trade names, logos and the like. ARTICLE X PATENT OWNERSHIP, KNOW-HOW AND WARRANTIES 10.1 LJP Patent Rights Ownership - Subject to the license rights granted to Abbott hereunder, LJP retains all ownership of all LJP Patent Rights and shall be responsible for filing, prosecuting, maintaining and defending LJP Patent Rights pursuant to Article XI. 10.2 Ownership of Joint Inventions - For all inventions (if any), made jointly by the Parties according to the named inventors therefor, which inventions arise from the performance of this Agreement, the Parties shall apply for patent protection therefor upon the written request of either Party. Patent protection for such invention(s) shall be applied for jointly in the name of the Parties as co-assignees and co-owners of such invention(s) and all patent application preparation, filing, maintenance and prosecution responsibilities and costs thereof in the Territory shall be shared equally by the Parties. If one of the Parties does not wish to share equally in the patent application and related costs and expenses in any country of the Territory, then the other Party may seek, obtain and maintain such patent(s) solely in its own name and at its sole expense and shall have sole and exclusive rights to use the inventions covered by such patent(s) without payment of any royalties or compensation to the non-paying Party. Without limiting the generality of the foregoing, in the event that either party does not wish to 39 40 share in such cost and expenses, then notwithstanding anything to the contrary contained in this Agreement, such party shall have no license or other rights in respect of such patent(s). Joint Inventions pursuant to this Section shall not be included within LJP Patent Rights. 10.3 LJP Patent Warranties - LJP warrants and represents that: (A) Appendix D sets forth all of the LJP Patent Rights as of the Effective Date; (B) LJP has not granted any licenses or other rights to any third party inconsistent with the licenses and other rights granted to Abbott hereunder; and (C) to the best of LJP's knowledge, LJP is not aware of any prior art which would cause LJP Patent Rights to be invalid and unenforceable, (D) to the best of LJP's knowledge there are no existing valid third party patents or other proprietary rights in the Territory that might be infringed by the manufacture, marketing, sale or use of the Product (excluding any aspects thereof other than Substance) in the Territory by Abbott, its Affiliates and Unaffiliated Sublicensees or by the manufacture of the Substance in the Territory by LJP and its Affiliates and approved subcontractors. 10.4 Know-How - LJP warrants and represents that as of the Effective Date, it is not subject to any legal or contractual obligations that would prohibit it from licensing or disclosing to Abbott any LJP Non-Manufacturing Know-How or LJP Manufacturing Know-How in accordance with the terms of this Agreement. 10.5 Abbott Intellectual Property - Except as expressly stated in Article IX, Section 10.2 and section 20.1 (C), Abbott Trademarks, Abbott Regulatory Know-How and all other Abbott owned or controlled trademarks, copyrights and patents shall remain the sole and exclusive property of Abbott and LJP shall acquire no rights thereto. 40 41 ARTICLE XI PATENT PROSECUTION AND INFRINGEMENT 11.1 Patent Filing and Prosecution - During the Term, except as otherwise provided in Section 10.2, LJP shall, at its sole expense, file, prosecute, maintain and defend LJP Patent Rights in the countries listed in Appendix D and LJP shall control all LJP Patent Rights filings and actions. LJP shall file and prosecute to obtain extensions of all LJP Patents included in LJP Patent Rights in any countries in which such extensions are available. Notwithstanding the foregoing, LJP shall not be required to file, maintain or defend any LJP Patent Rights or to obtain any LJP Patent extensions where LJP does not believe that such activities are commercially justified, except that LJP shall not, without Abbott's prior written consent, abandon (i) any currently issued LJP Patents, or (ii) any LJP Patent Applications or (iii) petitions for extensions of LJP Patent Rights. In the event that LJP determines that any of the foregoing activities are not commercially justified, LJP shall promptly notify Abbott, and Abbott shall have the right, at its sole expense, to undertake such activities. LJP shall assist Abbott, as reasonably requested by Abbott and at Abbott's expense, in the event Abbott determines to undertake such activities. 11.2 Notification of Infringement - The Parties shall promptly inform each other of any information that comes to their attention involving actual or apparent infringements or misappropriations of LJP Patent Rights, LJP Manufacturing Know-How, LJP Non-Manufacturing Know-How, Abbott Regulatory Know-How or Abbott Trademarks by any third party, or claims of alleged infringement made by any third party in the Territory against LJP, LJP Affiliates, Abbott, Abbott Affiliates, or any Unaffiliated Sublicensees resulting from the manufacture, import, offer for sale, sale or use of the Substance or the Product. 11.3 Infringement of Third Party Rights - LJP shall direct or defend in its own name and at its own expense any legal or other action or proceeding, including any 41 42 settlement or negotiation, with respect to any alleged infringement of a third party patent or other proprietary right as a result of Abbott, its Affiliates or Unaffiliated Sublicensees making, having made, using or selling the Product in the Territory (but only to the extent relating to the Substance) or LJP or its Affiliates or approved subcontractors manufacturing the Substance. Notwithstanding the foregoing, LJP may elect, following consultations with Abbott, not to defend any such action based on an analysis of the market potential in the affected country. During the pendency of any such proceeding or any appeal thereof, *** of royalties payable under Section 4.1 in the country in which such proceeding is pending shall be paid by Abbott into an interest-bearing escrow account pending the outcome of such proceeding. Upon a favorable final resolution of such proceeding or any appeal thereof, Abbott shall resume paying LJP full royalties in such country, and all funds in such escrow account shall be paid to LJP. Upon an unfavorable final resolution of such proceeding or any appeal thereof or if LJP fails to defend such action, the funds in such escrow account shall be applied toward the damage award in such action, if any, and the balance, if any, paid to LJP. 11.4 Termination for Infringement - Should Abbott be prevented by reason of a non-appealable judgment of a court of competent jurisdiction against it from making pursuant to Section 14.1 using or selling the Product in the United States or any Major Country, then, as to that part of the Territory so affected, Abbott may terminate this Agreement upon written notice to LJP, and the Parties shall make a final transition accounting and settlement for outstanding bona fide costs, payments and expenses to which each Party is entitled hereunder. 11.5 Third- Party Infringement of LJP Patents (A) LJP Enforcement - LJP shall, at its own expense, have the first right to commence appropriate measures to enforce LJP Patents against third party infringements after LJP becomes aware of such infringement including, but not limited to, 42 43 notifying the infringing third party of such infringement and demanding that such third party cease and desist from such infringement within the following time frames: (i) with respect to LJP Composition Patents, *** (ii) all other LJP Patents, *** in any of the countries listed in Appendix H. If such infringement does not cease, LJP shall commence a legal proceeding to enforce LJP Patents against third party infringements within *** of the date LJP becomes aware of such infringement. Upon LJP's request, Abbott shall provide reasonable assistance in pursuing infringers. LJP shall, at its own expense, use Commercially Reasonable Efforts to enforce its patents against unlicensed third parties selling Competing Products not encompassed by the LJP Patent Rights granted to Abbott. If LJP elects not to enforce such patents, Abbott shall have the option to commence legal proceedings pursuant to Section 11.5(B). (B) Abbott Enforcement - If within *** of the date LJP becomes aware of any alleged third party infringement, either directly or by notice from Abbott, LJP fails to commence a legal proceeding pursuant to Section 11.5A, or if at any time LJP discontinues such proceeding, Abbott may, at its option, commence, continue or intervene, as the case may be, in such proceeding. Abbott's commencement, continuation or intervention in such proceeding shall be at Abbott's own expense, provided that Abbott shall be entitled to retain all recoveries in such proceeding or any appeal thereof. Such commencement, continuation or intervention by Abbott shall not relieve LJP of its obligations under Section 11.5(A) provided that in any dispute resolution proceeding brought by Abbott against LJP for a breach of 43 44 Section 11.5(A) Abbott shall not be entitled to recover the costs of such commencement, continuation or intervention. (C) Notwithstanding (A) and (B) above, where statutory notice provisions apply, LJP shall have *** after LJP becomes aware of third party infringement to commence appropriate measures to enforce the Patents against third party infringement. After ***, provided LJP has not commenced legal actions, Abbott may at its option take action under 11.5 (B). 11.6 Allocation of Recoveries - In any action brought by or against a third party infringer, any monetary damages or compensation recoveries obtained in LJP's and/or Abbott's favor in connection with such actions shall be allocated as follows: (A) first, the prosecuting Party or Parties shall recover reasonable attorneys' fees and expenses and (B) the remainder shall be allocated between Abbott and LJP so as to fairly reflect (i) Abbott's lost profits and other damages, and (ii) the amounts that LJP would have been paid hereunder had Abbott made the lost sales for which Abbott is being compensated through such damage award. 11.7 Mutual Cooperation - In the event of any patent infringement litigation in the Territory involving the Product and any LJP Patent Rights, the non-prosecuting or non-defending Party shall render such reasonable assistance as may be requested by the prosecuting or defending Party in connection with such infringement actions. If one party requests the other Party's reasonable assistance in connection with such infringement claims or actions, the requesting Party shall reimburse the other Party for such direct, documented out-of-pocket expenses as are reasonably incurred during the course of its providing such requested assistance. Before incurring such expenses, the Parties shall in good faith agree in writing on the nature and extent of assistance to be 44 45 rendered, and an estimate of the total expenses, which expenses shall be monitored periodically. ARTICLE XII COMPETING PRODUCTS 12.1 Obligations With Respect to Competing Products - For a period from the Effective Date until (a) *** after the first Regulatory Approval in any country in the Territory, or (b) expiration or Termination of the Agreement, whichever is sooner, each Party and its Affiliates shall not ***. ARTICLE XIII PRODUCT WARRANTIES AND INDEMNIFICATION 13.1 Warranties and Limitations (A) LJP Warranties - LJP warrants and represents that the Substance and Interim Product manufactured by LJP, its Affiliates or approved subcontractors and delivered to Abbott, its Affiliates or Unaffiliated Sublicensees hereunder shall (i) from the date of shipment until the end of the specified shelf life conform to the Specifications and all applicable laws and regulations relating to the manufacture of the Substance and Interim Product, including, but not limited to, applicable supranational, national and local laws in the country where manufacturing occurs and U.S. FDA Good Manufacturing Practices and equivalent Good Manufacturing Practices in Europe and Japan to the extent applicable to LJP, its Affiliates or approved subcontractors as the 45 46 manufacturer(s) of the Substance and Interim Product and (ii) be transferred free and clear of any security interests, liens and encumbrances. (B) Limitations - Except as otherwise expressly stated herein, no warranties or representations, express or implied, including the warranties of fitness for a particular purpose and merchantability, regarding the Product, the Substance and Interim Product, or any other matters are made or shall be deemed to have been made by LJP. Subject to LJP's warranty and indemnification obligations hereunder for the Substance and Interim Product, LJP shall have no responsibility or liability for Product used, supplied, marketed, or sold by Abbott, its Affiliates or Unaffiliated Sublicensees after the Substance has been incorporated into Product by Abbott, its Affiliates or Unaffiliated Sublicensees. 13.2 Reciprocal Indemnification Provisions (A) LJP Indemnification - LJP shall defend, indemnify and hold Abbott, its Affiliates, and Unaffiliated Sublicensees, and the officers, directors, employees and agents of each, harmless from and against any and all liabilities, damages, claims, demands, costs, or expenses (including reasonable attorneys' fees) claimed by any third party for any property or other economic loss or damage or injury or death suffered by it to the extent the same is determined to have been caused by the negligence, fault, willful wrongdoing or any other act or omission or breach of this Agreement relating to LJP's, its Affiliates' or approved subcontractors' manufacture of the Substance and Interim Product supplied to Abbott, its Affiliates and Unaffiliated Sublicensees, subject to the conditions of indemnification set forth in Section 13.3. (B) Abbott Indemnification - Abbott shall defend, indemnify and hold LJP, its Affiliates and approved subcontractors, and the officers, directors, employees and agents of each, harmless from and against any and all liabilities, damages, claims, demands, or costs, or expenses (including reasonable attorneys' fees) claimed by any 46 47 third party for any property or other economic loss or damage, injury or death suffered by it to the extent the same is determined to have been caused by the negligence, fault, willful wrongdoing or any other act or omission, or breach of this Agreement relating to Abbott's, its Affiliates' or Unaffiliated Sublicensees' manufacture, development, registration, marketing or sale activities involving the Product, subject to the conditions of indemnification set forth in Section 13.3. 13.3 Conditions of Indemnification - With respect to any indemnification obligations of either Party to the other Party under this Agreement, including but not limited to the indemnification obligations of the Parties under Sections 13.2(A) and 13.2(B), the following conditions must be met for such indemnification obligations to become applicable: (A) the indemnified Party shall notify the indemnifying Party promptly in writing of any claim which may give rise to an obligation on the part of the indemnifying Party hereunder; (B) the indemnifying Party shall be allowed to timely undertake the sole control of the defense of any such action and claim, including all negotiations for the settlement, or compromise of such claim or action at its sole expense; and (C) the indemnified Party shall render reasonable assistance, information, co-operation and authority to permit the indemnifying Party to defend such action, it being agreed that any out-of-pocket expenses or other expenses incurred by the indemnified Party in rendering the same shall be borne or reimbursed promptly by the indemnifying Party. ARTICLE XIV STANDBY MANUFACTURING RIGHTS 14.1 Inability to Manufacture - LJP shall promptly notify Abbott in writing of any circumstances rendering it unable to manufacture or supply the Substance and the Interim Product for more than *** pursuant to its obligation under the Supply Agreement, Appendix G, and the estimated duration of such circumstances. If LJP is unable to supply the Substance and the Interim Product pursuant to its obligations 47 48 under the Supply Agreement, Appendix G, *** or more consecutive days for any reason (including but not limited to a Force Majeure event), representatives of the Parties shall meet to review the reasons for the inability to supply and discuss whether LJP, Abbott or a third party would be in the better position to resume or commence (as applicable) manufacture of the Substance and Interim Product as expeditiously as possible. If LJP (A) does not inform Abbott that LJP believes it (or its approved subcontractor) is in the better position to do so, with reasonable technical assistance from Abbott, or (B) LJP cannot demonstrate to Abbott's reasonable satisfaction that LJP (or its approved subcontractor) is in a better position to do so, with reasonable technical assistance from Abbott, then Abbott may, at its option and expense, elect to manufacture or have a third party manufacture subject to the limitations of this paragraph. Within *** after the Effective Date, and with updates as appropriate thereafter, LJP will place all regulatory filing documentation including the drug master file for Substance and Interim Product and all LJP Manufacturing Know-How documentation necessary for Abbott to manufacture the Substance and the Interim Product with an independent third party escrow agent for Abbott's use under this standby right. To the extent necessary to implement such standby manufacturing rights, LJP hereby grants Abbott a contingent non-exclusive license under LJP's Patent Rights and LJP Manufacturing Know-How to make, have made, use, import, the Substance and Interim Product in the Territory, which license shall become effective only under the circumstances specified in this Section 14, and LJP shall provide Abbott with such manufacturing assistance and documentation as Abbott may require in connection therewith. To the extent that Abbott's use of LJP's Manufacturing Know-How results in a liability for LJP to pay royalties to a third party, Abbott shall bear the expense of such royalties for the duration of Abbott's use of LJP's Manufacturing Know- 48 49 How. Abbott's exercise of this right will not supersede LJP's obligation to manufacture all of Abbott's requirements for Substance and the Interim Product. LJP shall notify Abbott when it can manufacture all of Abbott's requirements for Substance and the Interim Product, and then Abbott shall cease to manufacture or have manufactured within a reasonable time period, except where Abbott has incurred a substantial and irrevocable investment in facilities and equipment that is not reimbursed by LJP. LJP will also provide Abbott, at its expense, reasonable manufacturing support during the time when Abbott is exercising these standby manufacturing rights. 14.2 Mutual Agreement - In addition, LJP may, at any time, grant Abbott the option to exercise standby manufacturing rights for the Substance and the Interim Product upon such terms as shall be agreed upon in writing by the Parties, provided that such grant to Abbott shall not relieve LJP of its supply obligations under the Supply Agreement, Appendix G. ARTICLE XV MANUFACTURING INSPECTIONS AND CHANGES 15.1 Inspections - Each Party reserves the right to inspect the other Party's manufacturing facilities for the Substance, Interim Product and Product and related books and records at any time upon reasonable prior notice to the extent necessary or appropriate to ensure the other Party's compliance with the terms of this Agreement relating to the manufacture of Substance Interim Product and Product and prior to any Regulatory Approval and prior to LJP's commencement of manufacturing operations. The books and records subject to inspection include, but are not limited to, batch records, manufacturing procedures and guidelines, and all quality assurance/quality control documentation. Each party shall furnish to the other copies of all reports prepared concerning these inspections or audits. The foregoing books and records, and all information and data contained therein, shall be deemed LJP Confidential Information or Abbott Confidential Information hereunder, as applicable, and shall not 49 50 be used for any purpose other than as provided in the Section 15.1 or as otherwise expressly authorized in this Agreement. 15.2 Regulatory Inspections - LJP shall allow representatives of the U.S. FDA and any other regulatory agency or authority with jurisdiction over the manufacture of Substance or Interim Product to tour and inspect all facilities utilized by LJP in the manufacture, testing, packaging, storage, and shipment of the Substance Product or Interim Product sold under this Agreement, upon prior reasonable notice, and shall cooperate with such representatives in every reasonable manner. LJP shall notify Abbott promptly whenever LJP receives notice of a pending inspection of its manufacturing facilities by any regulatory agency. LJP shall also provide Abbott with a copy of any U.S. FDA Form 483 notices of adverse findings, regulatory letters or similar notifications it receives from any other governmental authority setting forth adverse findings or non-compliance with any applicable laws, regulations or standards relating to the items supplied by it hereunder within *** of its own receipt thereof. LJP shall also provide Abbott with a copy of LJP's proposed written response to such governmental authority before submission and shall incorporate any changes thereto which Abbott may reasonably and timely request. 15.3 Manufacturing Changes (A) Required Manufacturing Changes - Such changes that are required to comply with applicable laws and regulations shall be deemed "Required Manufacturing Changes." LJP shall implement Required Manufacturing Changes as soon as practicable in a reasonable time period, after receipt of Abbott's request or within the time frame required by the U.S. FDA or any corresponding regulatory authority in the Territory. If LJP does not implement Required Manufacturing Changes 50 51 within the time frame referenced in the preceding sentence or notify Abbott in writing that LJP disputes whether Abbott's requested changes are Required Manufacturing Changes, then Abbott shall have the option to exercise standby manufacturing rights for the Substance and the Product pursuant to Section 14.1 until such time as LJP implements such Required Manufacturing Changes except where Abbott shall incur a substantial and irrevocable investment in facilities and equipment which is not reimbursed by LJP. If LJP notifies Abbott in writing that LJP disputes whether Abbott's requested changes are Required Manufacturing Changes, then LJP shall implement such changes at Abbott's expense such changes at Abbott's expense and the Parties shall resolve such dispute by reference to a mutually agreed upon independent third party regulatory expert as soon as possible for a binding determination of whether the requested changes are Required Manufacturing Changes. If such independent third party regulatory expert determines that Abbott's requested changes are Required Manufacturing Changes, LJP shall repay Abbott for such changes as soon as possible. (B) Abbott-Initiated Manufacturing Changes - Abbott may, from time to time during the Term, make a written request for changes in LJP's manufacturing operations for the Substance or Interim Product that are not Required Manufacturing Changes, but that are intended to promote quality control/quality assurance and/or achieve greater efficiency or cost savings in the manufacturing process ("Other Manufacturing Changes"). These Other Manufacturing Changes are at Abbott's own expense except to the extent of manufacturing changes necessary to meet LJP's obligations under the Supply Agreement, Appendix G, Section 6.3 A. LJP shall give due consideration to making Other Manufacturing Changes. LJP shall have *** from receipt of Abbott's written request for Other Manufacturing Changes to provide Abbott a written response to such request indicating whether LJP shall comply with such request. 51 52 (C) LJP-Initiated Manufacturing Changes - During the Term, LJP shall not make any changes to its manufacturing operations for the Substance and Interim Product that could reasonably be expected to prevent LJP from complying with its regulatory obligations hereunder without the prior written consent of Abbott, which consent shall not be unreasonably withheld. Abbott shall provide, at LJP's request, reasonable regulatory assistance to implement such changes and the parties shall use their best efforts to effectively manage the frequency of these changes. ARTICLE XVI PRODUCT RECALLS 16.1 Recall Notification and Implementation - Each Party shall promptly notify the other Party in writing of any facts relating to the advisability of the recall, destruction or withholding from the market of the Product anywhere in the world (collectively, "Recall"). If at any time (A) any governmental or regulatory authority in the Territory issues a request, directive or order for a Recall; (B) a court of competent jurisdiction orders a Recall in the Territory; or (C) Abbott determines, following consultation with LJP (except in emergency situations in which there is insufficient time for such consultation), that a Recall in the Territory is necessary or advisable, Abbott shall take all appropriate corrective actions to effect the Recall and LJP shall provide Abbott with such cooperation in connection with the Recall as Abbott may reasonably request. 16.2 Recall Costs and Expenses - Each Party shall bear the costs and expenses of any Recall in the Territory to the extent such Recall is the result of any fault attributable to that Party or its Affiliates. 16.3 Records of Sales - Both Parties shall keep for *** after termination of this Agreement records of their respective sales and customers and batch reports of 52 53 Products sufficient to adequately administer a recall of any Product and to fully cooperate in any decision to recall, retrieve and/or replace any Product. ARTICLE XVII ADVERSE DRUG EXPERIENCES During the Term, each Party shall promptly inform the other Party of any information it obtains or develops regarding the safety of the Product anywhere in the world and shall promptly report to the other Party any information regarding serious adverse reactions or side effects related to the use of the Product. The responsibility for determining the Party informing the appropriate regulatory authority will be defined in the Developmental Plan. To allow the Parties to comply with the adverse drug experience reporting requirements for the Product to the U.S. FDA and its counterpart regulatory agencies around the world, each Party shall notify the other Party in writing of any "adverse drug experience" that is considered "serious" and adverse as defined in U.S. FDA regulations (21 CFR 314.80) or the comparable regulations of other regulatory agencies, regardless of source, so that the other Party will receive such notice within *** of a Party's first having "obtained or otherwise received" such "adverse drug experience" from "any source", or in a time period for expedited reporting as agreed to by the appropriate regulatory authority as those terms are defined in U.S. FDA regulations (21 CFR 314.80) and other equivalent country regulations. Such information shall be communicated by the Parties to each other at the following addresses: To Abbott: Abbott Laboratories Attn: Manager, Medical Product Complaints Dept. 98Q, Bldg. AP30 200 Abbott Park Road Abbott Park, Illinois, USA 60064-3500 Telephone: (847) *** Facsimile: (847) *** To LJP: La Jolla Pharmaceutical Company Attn: Vice President, Clinical Development 53 54 6455 Nancy Ridge Drive, San Diego, California, USA 92121 Telephone: (619) *** Facsimile: (619) *** Each Party shall provide the other with copies of all adverse drug experience reports on the Product filed with the U.S. FDA or other regulatory agencies in the Territory. ARTICLE XVIII REPRESENTATIONS, WARRANTIES AND COVENANTS 18.1 Mutual Representations and Warranties Each Party hereby represents and warrants to the other Party as follows: (A) Corporate Status - It is a corporation duly organized and validly existing under the laws of its state or other jurisdiction of incorporation or formation; (B) Authority - It has the power and authority to execute and deliver this Agreement, and to perform its obligations hereunder; (C) No Conflicts - The execution, delivery and performance by it of this Agreement and its compliance with the terms and provisions hereof does not and will not conflict with or result in a breach of any of the terms and provisions of or constitute a default under (i) any loan agreement, guaranty, financing agreement, agreement affecting a product or other agreement or instrument binding or affecting it or its property; (ii) the provisions of its charter documents or by-laws; or (iii) any order, writ, injunction or decree of any court or governmental authority entered against it or by which any of its property is bound; (D) No Approvals - Except for the regulatory filings and approvals for the Product referenced herein, no authorization, consent or approval of any 54 55 governmental authority or third party is required on the part of such Party for the execution, delivery or performance by it of this Agreement, and the execution, delivery or performance of this Agreement on the part of such Party will not violate any law, rule or regulation applicable to such Party; (E) Enforceability - This Agreement has been duly authorized, executed and delivered on the part of such Party and constitutes its legal, valid and binding obligation enforceable against it in accordance with its terms subject, as to enforcement, to bankruptcy, insolvency, reorganization and other laws of general applicability relating to or affecting creditors' rights and to the availability of particular remedies under general equity principles; and (F) Compliance With Laws - It shall comply with all applicable laws and regulations relating to its activities under this Agreement. 18.2 Each Party covenants: (A) To keep the other Party informed as to any material problems discovered by that Party relating to the Substance, the Interim Product or the Product and any resolutions implemented for such problems; and (B) To promptly notify the other Party of any actual or potential government action relating to the Substance, the Interim Product or the Product and to discuss with the other Party the appropriate response to such action. ARTICLE XIX TERM AND EARLY TERMINATION RIGHTS 19.1 Term - The Term shall be as stated in Section 1.35 19.2 Termination for Cause - Either Party shall have the right, without prejudice to any other rights or remedies available to it, to terminate this Agreement for cause by written notice to the other Party in any of the following events: 55 56 (A) Bankruptcy - If the other Party is unable to fulfill its obligations and becomes insolvent, is adjudged bankrupt, applies for judicial or extra-judicial settlement with its creditors, makes an assignment for the benefit of its creditors, voluntarily files for bankruptcy or has a receiver or trustee (or the like) in bankruptcy appointed by reason of its insolvency, or in the event an involuntary bankruptcy action is filed against the other Party and not dismissed within ninety (90) days, or if the other Party becomes the subject of liquidation or dissolution proceedings, which proceedings are not dismissed within ninety (90) days, or otherwise discontinues business. (B) Material Breach - If the other Party commits a Material Breach of this Agreement (as defined in Section 24.2 (C) ) and the Party alleged to be in breach fails to either (i) cure such breach within *** after receipt of written notice from the Party asserting the breach, or (ii) commence dispute resolution proceedings under Article XXIV contesting whether a breach has occurred and/or whether such breach is a Material Breach within *** after receipt of written notice from the Party asserting the breach. 19.3 Termination by Mutual Agreement - This Agreement may be terminated at any time by written agreement of the Parties. 19.4 Termination by Abbott (A) FDA or other Regulatory Authority Decision - If at any time during the Term, the U.S. FDA or other Major Country Regulatory Authority reaches a final decision, not subject to further action or discussion within the U.S. FDA, or other Major 56 57 Country Regulatory Authority that there can be no further testing or use of the Substance, Interim Product, or Product in humans, then Abbott shall have the right at any time within *** following such decision, to terminate this Agreement at Abbott's option either in its entirety or on a country by country basis, upon *** prior written notice to LJP. (B) Safety or Efficacy - In addition, if at any time during the Term, but in no event prior to the first anniversary of the Effective Date (i) Abbott decides not to file an application for Regulatory Approval in the United States or a Major Country or decides to withdraw such applications previously filed in the United States or in a Major Country in each case due to documented adverse reactions or other safety issues based on a scientifically documented test with the Product or the Product's lack of efficacy or limited efficacy (collectively, "Safety or Efficacy Issues") or (ii) Abbott's application for Regulatory Approval in the United States or a Major Country is rejected due to Safety or Efficacy Issues or (iii) Abbott's application(s) for Regulatory Approval in the United States or a Major Country is subsequently withdrawn because of Safety or Efficacy Issues or (iv) the Product is withdrawn or recalled from the market in the United States or a Major Country because of Safety or Efficacy Issues, then Abbott may, at its option, terminate this Agreement with respect only to the affected country upon sixty (60) days prior written notice to LJP. If Abbott does so, Abbott's termination notice shall specify the country or countries of the Territory affected. (C) Without Cause - Within *** of the availability of the final Abbott approved scientific report of the 90 - 05 Study, Abbott shall have the right to terminate this Agreement without cause upon *** prior written notice to LJP. 57 58 ARTICLE XX CONSEQUENCES OF TERMINATION 20.1 Effect of Termination (A) Termination or expiration of this Agreement in its entirety or on a country-by-country basis through any means and for any reason shall not relieve the Parties of any obligations, including without limitation all payment obligations accruing prior to termination or expiration, including, but not limited to, milestone and incentive payments, Abbott purchase of Substance and Interim Product which have been properly ordered, funding of all approved ongoing development expenses which cannot be canceled, and royalties accrued and unpaid at the effective date of such termination, and shall be without prejudice to the rights and remedies of either Party with respect to any prior breach of any of the provisions of this Agreement. (B) In case of termination of this Agreement, Abbott shall retain no rights whatsoever to Products, Substance, LJP Patent Rights, LJP Manufacturing Know-How and LJP Non-Manufacturing Know-How, LJP Inventions or LJP Confidential Information relating thereto (C) If this Agreement is terminated, for any reason other than by Abbott pursuant to Section 19.2, (i) the parties shall work together to stop or transfer to LJP, at LJP's option, in an efficient and effective manner, all recently started or ongoing joint programs and not to initiate any new joint programs; (ii) Abbott will fully cooperate with LJP in the rapid transfer of all available Confidential Information to LJP, as well as all appropriate information concerning ongoing clinical studies, regulatory and marketing matters, etc; (iii) the parties will agree on appropriate terms of a non-exclusive license with a reasonable royalty which shall enable LJP to exploit any Inventions in relation to Substance or Products made by Abbott hereunder; and (iv) Abbott will also transfer to LJP the ownership and title and all documentation related to all pending and approved 58 59 regulatory filings, registration documents, information, and data for Products in the Territory. If Abbott chooses to terminate this Agreement, LJP will have the right to review and preapprove within *** the text and timing of all announcements related to termination, provided that such approval shall not be unreasonably withheld. (D) In the event of a termination of this Agreement as to a particular country, and not as a whole, the reciprocal non-competition obligations of the Parties under Section 12.1 shall no longer apply to that country, provided that each party shall use Commercially Reasonable Efforts, consistent with any applicable laws or regulations, to ensure that Competing Products are not developed, marketed or sold in that country for export, to or sale in another country to which the reciprocal non-competition obligations of the Parties under Section 12.1 remain applicable. (E) The Party's respective indemnification obligations hereunder shall survive any expiration or termination of this Agreement. The limitation of damages set forth in Article 25 hereof shall survive expiration or termination of this Agreement. 20.2 License Rights - If Abbott terminates this Agreement pursuant to Section 19.4 or if LJP terminates this Agreement pursuant to Section 19.2, Abbott's license rights in LJP Patent Rights and LJP Manufacturing Know How and LJP Non-Manufacturing Know How hereunder shall terminate. 20.3 Fully Paid-Up License - Except as otherwise provided in Section 4.1 or 20.2, upon expiration of the Term of this Agreement, Abbott's license rights in LJP Patent Rights and LJP Non-Manufacturing Know-How hereunder shall become nonexclusive, fully paid-up and irrevocable. 20.4 Mutual Agreement - If the Parties terminate this Agreement by mutual written agreement pursuant to Section 19.3, the Parties shall specify the consequences of such termination in such written agreement. 59 60 ARTICLE XXI NOTICES 21.1 Manner of Giving Notices - All notices required or permitted in connection with this Agreement shall be writing and may be given by personal delivery, prepaid registered or certified mail, telegram, telex or telecopier, addressed to the Party to receive the same at its address set forth below, or to such other address as it shall later designate by like notice to the other Party. Notice of termination of this Agreement if given by telex, telegram or telecopier, shall be confirmed by prepaid registered or certified mail dated and posted within twenty-four (24) hours. The effective date of receipt of any notice if served by telegram, telex or telecopier shall be deemed the first business day in the city of destination following the dispatch thereof and if given by mail only, it shall, unless earlier received, be deemed effective not later than five (5) days after the date of posting. Notice by personal delivery shall be effective as of the date of such delivery. 21.2 Addresses for Notices Notices to LJP shall be sent to: La Jolla Pharmaceutical Company Attn: President and CEO 6455 Nancy Ridge Drive San Diego, California, USA 92121 Facsimile: (619) *** With a copy to: Morrison & Foerster, LLP 755 Page Mill Road Palo Alto, California, USA 94304 60 61 Attn: Thomas E. Ciotti, Esq. Facsimile: (415) *** Notices to Abbott shall be sent to: Abbott Laboratories Hospital Products Division Attn: President Dept. 0960, Bldg. AP30 200 Abbott Park Road Abbott Park, Illinois, USA 60064-3500 Facsimile: (847) *** and Abbott Laboratories Abbott International Attn: President Dept. 06WP, Bldg. AP30 200 Abbott Park Road Abbott Park, Illinois, USA 60064-3500 Facsimile: (847) *** With a copy to: Abbott Laboratories General Counsel Dept. 364, Bldg. AP6C 100 Abbott Park Road Abbott Park, Illinois, USA 60064-3500 Facsimile: (847) *** 21.3 Notification - Abbott shall also be responsible for notifying, reporting or registering this Agreement or the business relationship created hereby with any government authorities in the Territory to the extent legally required. LJP shall provide Abbott with such assistance as Abbott may reasonably request in connection therewith. ARTICLE XXII INTEGRATION This Agreement and the Stock Purchase Agreement represent the entire Agreement between the Parties relating to the subject matter hereof and supersedes all 61 62 prior understandings, and agreements between the Parties, whether written or oral, including, but not limited to the confidentiality agreements between the Parties dated November 20, 1995 and January 25, 1996. No supplement, modification or amendment of this Agreement shall be binding unless executed by the Parties in writing and signed by the duly authorized representatives of both Parties. ARTICLE XXIII ASSIGNMENT Neither Party may assign this Agreement or any of its rights hereunder, nor delegate any of its duties or obligations hereunder, to any third party without the prior written consent of the other Party, except (i) to an Affiliate, or (ii), in connection with the acquisition of either Party, whether by merger, consolidation, or sale of all or substantially all of its assets. It shall be a condition to the effectiveness of any permitted assignment that the assignee agree in writing to be bound by all terms and conditions of this Agreement and to assume all of the assignor's obligations hereunder. In the case of an assignment to an Affiliate, the assignor shall remain liable for all of its obligations hereunder. Any attempted assignment in violation of the foregoing shall be null and void. In the event that LJP decides to sell or otherwise dispose of its manufacturing operations relating to the supply of the Substance, including, but not limited to in connection with an acquisition of LJP as a whole, LJP shall provide Abbott with notice thereof and an opportunity to make an offer to acquire such operations, subject in each case to any legal or contractual restrictions on LJP's ability to provide such notice and opportunity. ARTICLE XXIV GOVERNING LAW AND DISPUTE RESOLUTION 24.1 Governing Law - This Agreement, including the validity, construction, interpretation and performance thereof, shall be governed entirely by the laws of the State of California, USA, without regard to its conflict of laws provisions. It is the 62 63 specific intent and agreement of the Parties that the United Nations Convention on the International Sale of Goods shall not apply to this Agreement. 24.2 Dispute Resolution - All disputes arising out of or in connection with this Agreement, except those involving actions commenced by or involving third parties and affecting or involving only one of the Parties or involving a breach of Section 8.1, 8.2 and 8.3, shall be resolved with the following mechanism: (A) Attempted Amicable Resolution - The Parties shall promptly give each other written notice of any disputes requiring resolution hereunder, which written notice shall specify the Section (s) of this Agreement the other Party is alleged to have breached and shall briefly state the initiating Party's claims, and the Parties shall use reasonable efforts to resolve any such disputes in an amicable manner. Any disputes arising in connection with this Agreement which cannot be resolved in an amicable manner by representatives of the Parties shall be referred, not later than thirty (30) days after initiation of dispute resolution proceedings under this Section 24.2, to the following corporate officers of the Parties for resolution: For Abbott: President of the Hospital Products Division or Abbott International President as determined by Abbott (or his or her designee) 63 64 For LJP: President and CEO of LJP (or his or her designee) Such officers (or their designees) shall attempt to resolve the dispute and shall communicate with each other by facsimile or telephone or in personal meetings in an effort to resolve the dispute. (B) Alternative Dispute Resolution - Any disputes arising in connection with this Agreement which cannot be resolved by the Parties within twenty eight (28) days after initiation of dispute resolution proceedings under Section 24.2 shall be finally settled by binding Alternative Dispute Resolution in accordance with the procedure set forth in Appendix F. Judgment upon any award rendered by the neutral in such proceedings may be issued and enforced by any court having competent jurisdiction. (C) ADR Ruling - The neutral in any ADR proceeding under Section 24.2 shall determine and advise the Parties in writing: (i) whether either Party has committed a breach of any of its obligations under this Agreement; and (ii) if either Party has committed a breach; (a) whether such breach is a Material Breach or a breach other than a Material Breach; and (b) the appropriate remedy for any such breach pursuant to Section 24.2 D. As used herein, "Material Breach" by Abbott shall mean (i) a failure by Abbott to pay any milestone or incentive payments pursuant to Section 3.1 or 4.2 or any royalty payments pursuant to Section 4.1 or any other amount owing to LJP hereunder within *** of written notice of breach from LJP, or (ii) a failure by Abbott to purchase LJP 64 65 common stock required to be purchased under the Stock Purchase Agreement within *** of Abbott's receipt of written notice of breach from LJP, or (iii) any breach by Abbott of its non-competition obligations under Section 12.1 that is not remedied within *** of Abbott's receipt of written notice of breach from LJP. As used herein, "Material Breach" by LJP shall mean (i) a failure by LJP to pay any amount owing to Abbott that is not remedied within *** of LJP's receipt of written notice of breach from Abbott, or (ii) any breach by LJP of its non-competition obligations under Section 12.1 that is not remedied within *** of LJP's receipt of written notice of breach from Abbott. If either Party is alleged to have committed a Material Breach as defined above and disputes in good faith whether a Material Breach has occurred, the affected Party may initiate an ADR proceeding hereunder within the above *** notice period without having this Agreement terminated, provided the affected Party complies with the ruling of the ADR neutral with respect to the alleged Material Breach. (D) Remedies - The neutral in any ADR proceeding under Section 24.2 shall have the authority to award the non-breaching Party the following relief (except as otherwise provided in Section 24.2F): (i) for a Material Breach, an order to pay the amount due, an award of damages, if any, and equitable relief, if appropriate, and termination of this Agreement; and (ii) for a breach other than a Material Breach, an award of damages and/or equitable relief. (E) Dispute Resolution for Sections 7.1 and 7.2 - LJP shall be entitled to commence dispute resolution proceedings pursuant to Section 24.2 to challenge 65 66 Abbott's compliance with its Commercially Reasonable Efforts obligations in the United States or any Major Country pursuant to Sections 7.1 and 7.2, not more than once every *** for each respective country. The determination of whether Abbott has used its Commercially Reasonable Efforts in each respective country shall be based on the totality of circumstances. If LJP successfully establishes that Abbott has failed to use its Commercially Reasonable Efforts, in any given country (i) for *** such violations, the ADR neutral shall have the authority to award damages or equitable relief to LJP (but not termination of Abbott's license rights in such country) and (ii) for *** violations in the same country, the ADR neutral shall have the authority to award, in the ADR neutral's discretion, damages, equitable relief and/or termination of Abbott's license rights in the country where such breach occurs. (F) Breach of Confidentiality Obligation - For an alleged breach of Sections 8.1, 8.2 or 8.3, either Party may, at its option, initiate judicial proceedings to seek injunctive relief against the breaching Party, but not any other type of relief, provided that the injured Party may also seek money damages in an ADR proceeding. 24.3 Effect of Commencing Dispute Resolution - If either Party in good faith commences dispute resolution proceedings under Section 24.2, (A) any applicable notice periods or cure periods hereunder shall be temporarily suspended pending the outcome of such dispute resolution proceedings and (B) the initiating Party may, at its option, pay any amounts payable to the other Party that are in dispute into an interest-bearing escrow account pending the outcome of such dispute resolution proceedings. 66 67 ARTICLE XXV LIMITATION OF DAMAGES In no event shall either Party be liable to the other Party for any indirect, incidental or consequential damages in connection with the performance of this Agreement or any breach of this Agreement. ARTICLE XXVI FORCE MAJEURE Neither Party shall be held in breach of this Agreement for failure to perform any of its obligations hereunder (other than the payment of amounts due hereunder) to the extent and for the time period such performance is prevented in whole or in part by reason of any Force Majeure event, including but not limited to industrial disputes, strikes, lockouts, riots, mobs, fires, floods, and other natural disasters and Acts of God, wars declared or undeclared, civil strife, embargo, delays in delivery or defects or shortages of raw materials from suppliers, loss or breakdown of any production equipment, losses or shortage of power, damage to or loss of goods in transit, currency restrictions, or events caused by reason of laws, regulations or orders by any government, governmental agency or instrumentality or by any other supervening unforeseeable circumstances whatsoever beyond the control of the Party so affected. The Party so affected shall (A) give prompt written notice to the other Party of the nature and date of commencement of the Force Majeure event and its expected duration and (B) use its reasonable efforts to avoid or remove the Force Majeure event as soon as possible to the extent it is so able to do. ARTICLE XXVII RELATIONSHIP OF PARTIES The relationship of the Parties under this Agreement is that of independent contractors. Nothing contained in this Agreement shall be construed so as to constitute 67 68 the Parties as partners, joint venturers or agents of the other. Neither Party has any express or implied right or authority under this Agreement to assume or create any obligations or make any warranties and representations on behalf of or in the name of the other Party, or to bind the other Party to any contract, agreement or undertaking with any third party, and no conduct of the Parties pursuant to the terms of this Agreement shall be deemed to establish such right or authority. Neither Party shall make any representation to third parties that the relationship created hereby constitutes a partnership, joint venture or agency relationship. ARTICLE XXVIII SEVERABILITY OF CLAUSES In case one or more of the provisions contained in this Agreement shall, for any reason, be held invalid, illegal or unenforceable in any respect, such invalidity, illegality or unenforceability shall not affect any other provisions of this Agreement, but this Agreement shall be construed by limiting such invalid, illegal or unenforceable provision, if such is not possible, by deleting such provision from this Agreement. ARTICLE XXIX NON-WAIVER The failure by either Party at any time to enforce any of the terms or provisions or conditions of this Agreement or exercise any right hereunder shall not constitute a waiver of the same or affect that Party's rights thereafter to enforce or exercise the same. No waiver of any of the provisions of this Agreement shall be deemed binding unless executed in writing by the Party to be bound by it. ARTICLE XXX HEADINGS The headings in this Agreement are for convenience of reference only and shall not be used in the interpretation of any provisions hereof. 68 69 ARTICLE XXXI EXECUTION This Agreement shall be executed by the Parties in two (2) original counterparts, one (1) original counterpart being retained by each Party and either of which shall be deemed sufficient to prove the existence and terms and conditions hereof. This Agreement may be executed by the Parties by the exchange of facsimile signature pages, with signed original counterparts of the Agreement to be exchanged by the Parties promptly thereafter. IN WITNESS WHEREOF, the Parties' duly authorized representatives hereto have executed this Agreement as of the Effective Date. LA JOLLA PHARMACEUTICAL ABBOTT LABORATORIES COMPANY By: /s/ Steven B. Engle By: /s/ Robert L. Parkinson, Jr. --------------------------- ---------------------------------- Title: President & CEO Title: Senior Vice President, International Operations Date: 12/23/96 Date: 12/23/96 69 70 APPENDIX A DEFINITION OF SUBSTANCE *** 70 71 APPENDIX B FULLY BURDENED DEVELOPMENT COST *** 71 72 *** 72 73 *** 73 74 *** 74 75 *** 75 76 *** 76 77 APPENDIX C FULLY BURDENED MANUFACTURING COST Definitions *** 77 78 *** 78 79 *** 79 80 *** 80 81 APPENDIX D PART I LJP PATENTS *** 81 82 *** 82 83 APPENDIX D PART II LJP PATENT APPLICATIONS *** 83 84 APPENDIX D PART II (CONT'D) LJP PATENT APPLICATIONS *** 84 85 APPENDIX E SPECIFICATIONS 1.0 SPECIFICATIONS FOR INTERIM PRODUCT Test Specification *** *** 2.0 SPECIFICATIONS FOR SUBSTANCE Test Specification *** *** 85 86 *** *** 86 87 APPENDIX F ALTERNATIVE DISPUTE RESOLUTION The parties recognize that a bona fide dispute as to certain matters may arise from time to time during the term of this Agreement which relates to either party's rights and/or obligations. To have such a dispute resolved by the Alternative Dispute ("ADR") provision, a party first must send written notice of the dispute to the other party for attempted resolution by good faith negotiations between their respective presidents (or their equivalents) of the affected subsidiaries, divisions, or business units within twenty-eight (28) days after such notice is received (all references to "days" in this ADR provision are to calendar days). If the matter has not been resolved within twenty-eight (28) days of the notice of dispute, or if the parties fail to meet within such twenty-eight (28) days, either party may initiate an ADR proceeding as provided herein. The parties shall have the right to be represented by counsel in such a proceeding. 1. To begin an ADR proceeding, a party shall provide written notice to the other party of the issues to be resolved by ADR. Within fourteen (14) days after its receipt of such notice, the other party may, by written notice to the party initiating the ADR, add additional issues to be resolved within the same ADR. 2. Within twenty-one (21) days following receipt of the original ADR notice, the parties shall select a mutually acceptable neutral to preside in the resolution of any disputes in this ADR proceeding. If the parties are unable to agree on a mutually acceptable neutral within such period, either party may request the President of the CPR Institute for Dispute Resolution ("CPR"), 366 Madison Avenue, 14th Floor, New York, New York 10017, to select a neutral pursuant to the following procedures: (a) The CPR shall submit to the parties a list of not less than five (5) candidates within fourteen (14) days after receipt of the request, along with a Curriculum Vitae for each candidate. No candidate shall be an employee, director, or shareholder of either party or any of their subsidiaries or affiliates. (b) Such list shall include a statement of disclosure by each candidate of any circumstances likely to affect his or her impartiality. (c) Each party shall number the candidates in order of preference (with the number one (1) signifying the greatest preference) and shall deliver the list to the CPR within seven (7) days following receipt of 87 88 the list of candidates. If a party believes a conflict of interest 18 exists regarding any of the candidates, that party shall provide a written explanation of the conflict to the CPR along with its list showing its order of preference for the candidates. Any party failing to return a list of preferences on time shall be deemed to have no order of preference. (d) If the parties collectively have identified fewer than three (3) candidates deemed to have conflicts, the CPR immediately shall designate as the neutral the candidate for whom the parties collectively have indicated the greatest preference. If a tie should result between two candidates, the CPR may designate either candidate. If the parties collectively have identified three (3) or more candidates deemed to have conflicts, the CPR shall review the explanations regarding conflicts and, in its sole discretion, may either (i) immediate designate as the neutral the candidate for whom the parties collectively have indicated the greatest preference, or (ii) issue a new list of not less than five (5) candidates, in which case the procedures set forth in subparagraphs 2(a) - 2(d) shall be repeated. 3. No earlier than twenty-eight (28) days or later than fifty-six (56) days after selection, the neutral shall hold a hearing to resolve each of the issues identified by the parties. The ADR proceeding shall take place at a location agreed upon by the parties. If the parties cannot agree, the neutral shall designate a location other than the principal place of business of either party or any of their subsidiaries or affiliates. Each party to the proceeding shall be entitled to make one document request to the other party, subject to the right of the neutral to rule on any objections to such request, which shall not be subject to appeal. 4. At least seven (7) days prior to the hearing, each party shall submit the following to the other party and the neutral: (a) a copy of all exhibits on which such party intends to rely in any oral or written presentation to the neutral; (b) a list of any witnesses such party intends to call at the hearing, and a short summary of the anticipated testimony of each witness; (c) a proposed ruling on each issue to be resolved, together with a request for a specific damage award or other remedy for each issue. The proposed rulings and remedies shall not contain any recitation of the facts or any recitation of the facts or any legal arguments and shall not exceed one (1) page per issue. 88 89 (d) a brief in support of such party's proposed rulings and remedies, provided that the brief shall not exceed twenty (20) pages. This page limitation shall apply regardless of the number of issues raised in the ADR proceeding. 5. The hearing shall be conducted on two (2) consecutive days and shall be governed by the following rules: (a) Each party shall be entitled to five (5) hours of hearing time to present its case. The neutral shall determine whether each party has had the five (5) hours to which it is entitled. (b) Each party shall be entitled, but not required, to make an opening statement, to present regular and rebuttal testimony, documents or other evidence, to cross-examine witnesses, and to make a closing argument. Cross-examination of witnesses shall occur immediately after their direct testimony, and cross-examination time shall be charged against the party conducting the cross-examination. (c) The party initiating the ADR shall begin the hearing and, if it chooses to make an opening statement, shall address not only issues it raised but also any issues raised by the responding party. The responding party, if it chooses to make an opening statement, also shall address all issues raised in the ADR. Thereafter, the presentation of regular and rebuttal testimony and documents, other evidence, and closing arguments shall proceed in the same sequence. (d) Except when testifying, witnesses shall be excluded from the hearing until closing arguments. (e) Settlement negotiations, including any statements made therein, shall not be admissible under any circumstances. Affidavits prepared for purposes of the ADR hearing also shall not be admissible. As to all other matters, the neutral shall have sole discretion regarding the admissibility of any evidence. 6. Within seven (7) days following completion of the hearing, each party may submit to the other party and the neutral a post-hearing brief support of its proposed rulings and remedies, provided that such brief shall not contain or discuss any new evidence and shall not exceed ten (10) pages. This page limitation shall apply regardless of the number of issues raised in the ADR proceeding. 89 90 7. The neutral shall rule on each disputed issue within fourteen (14) days following completion of the hearing. Such ruling shall adopt in its entirety the proposed ruling and remedy of one of the parties on each disputed issue but may adopt one party's proposed rulings and remedies on some issues and the other party's proposed rulings and remedies on other issues. The neutral shall not issue any written opinion or otherwise explain the basis of the ruling. 8. The neutral shall be paid a reasonable fee plus expenses. These fees and expenses, along with the reasonable legal fees and expenses of the prevailing party (including all expert witness fees and expenses), the fees and expenses of a court reporter, and any expenses for a hearing room, shall be paid as follows: (a) If the neutral rules in favor of the one party on all disputed issues in the ADR, the losing party shall pay 100% of such fees and expenses. (b) If the neutral rules in favor of one party on some issues and the other party on other issues, the neutral shall issue with the rulings a written determination as to how such fees and expenses shall be allocated between the parties. The neutral shall allocate fees and expenses in a way that bears a reasonable relationship to the outcome of the ADR, with the party prevailing on more issues, or on issues of greater value or gravity, recovering a relatively larger share of its legal fees and expenses. 1. The rulings of the neutral and the allocation of fees and expenses shall be binding, non-reviewable, and non-appealable, and may be entered as a final judgment in any court having jurisdiction. 2. Except as provided in paragraph 9 or as required by law, the existence of the dispute, any settlement negotiations, the ADR hearing, any submissions (including exhibits, testimony, proposed rulings, and briefs), and the rulings shall be deemed Confidential Information. The neutral shall have the authority to impose sanctions for unauthorized disclosure of Confidential information. 90 91 APPENDIX G SUPPLY AGREEMENT 1. LJP Supply Obligations 1.1 Substance and Interim Product Supply - Subject to the terms and conditions of this Supply Agreement prior to Initial Commercial Sales of Product, LJP shall supply Abbott, its Affiliates and Unaffiliated Sublicensees with their requirements of Interim Product. Subject to the terms and conditions of this Supply Agreement during the Term, LJP shall supply Abbott, its Affiliates and Unaffiliated Sublicensees with their requirements of Substance. 1.2 Delivery - LJP shall supply the Substance and the Interim Product to Abbott only against receipt of Abbott's written purchase orders. Except as otherwise provided herein or as otherwise expressly agreed in writing by the Parties, delivery shall be within *** from receipt and acceptance of Abbott's purchase order or later as specified in the written purchase order from Abbott. LJP shall accept and confirm in writing the delivery dates within *** after receipt of Abbott's purchase orders and, subject to the provisions of Section 5.1, LJP shall use Commercially Reasonable Efforts to fill such orders on the requested delivery dates, but shall in any event fill such orders to the extent consistent with the forecast described below within *** from receipt and acceptance of Abbott's purchase order, unless the Abbott written purchase order requests delivery for a later date. LJP shall deliver the Substance and the Interim Product F.O.B. plant to a carrier designated by Abbott. Abbott shall pay shipping costs and shall assume title to and risk of loss for the Substance and the Interim Product purchased hereunder upon delivery to Abbott's designated carrier. 91 92 1.3 Acknowledgment - Within *** after receipt of any Purchase Order from Abbott, LJP shall respond in writing confirming Abbott's Purchase Order (an "Acknowledgment"), provided that such Purchase Order is consistent with the terms of this Agreement. LJP's failure to acknowledge a written purchase order within *** of receipt shall be deemed to be acceptance of such Purchase Order in its entirety, subject to all conditions in this Agreement. Purchase Orders may be made in any form including computer-generated reports and telefaxes. Abbott shall use Commercially Reasonable Efforts to schedule orders to avoid creating over or under capacity problems for LJP. 1.4 Shipping Instructions - Abbott shall provide LJP with appropriate instructions for each shipment of the Substance and the Interim Product hereunder designating the desired carrier, destination and method of transport. If LJP becomes aware that the designated carrier is unable to accept the desired shipment within the requested delivery period, LJP shall promptly notify Abbott and Abbott shall promptly designate another carrier or carriers. 2. LJP Affiliates and Approved Subcontractors - LJP may satisfy its supply obligations under this Agreement either directly or through any LJP Affiliate, provided that each manufacturing site utilized by such LJP Affiliate has received all required regulatory approvals and that LJP guarantees the performance of such Affiliate, and such supply by LJP or by LJP Affiliates shall not be deemed an infringement of Abbott's exclusive rights hereunder. LJP may not subcontract its supply obligations under this Agreement to any party other than an LJP Affiliate without Abbott's prior written consent, not to be unreasonably withheld. 3. LJP Manufacturing Capabilities: Manufacturing Plan - LJP shall be responsible for developing capabilities to manufacture Substance and the Interim 92 93 Product, filing manufacturing-related regulatory documents (e.g., drug master file), Manufacturing Scale Up and the capital investment in a commercial manufacturing facility based on progress under the Development Plan, clinical testing results, and Abbott's market forecasts. Abbott and LJP shall jointly develop a manufacturing plan for the Substance and the Product ("Manufacturing Plan") which shall contain equipment throughput, yield and capacity assumptions, capital requirements and timing associated with manufacturing. Abbott and LJP shall update the Manufacturing Plan at least semi-annually and upon reviewing the dose maintenance results. 4. Forecasts and Ordering 4.1 Intent - LJP will attempt to meet all of Abbott's requirements for Substance. Abbott and LJP recognize that it is difficult to accurately forecast new product material requirements, especially during the launch of a new product. Nonetheless, the parties understand that this Appendix is designed to permit LJP to plan the size of its manufacturing facility, and its production schedules to meet Abbott's needs in an uncertain situation. The parties agree to cooperate closely in order to assure an efficient and effective process. LJP will, with the assistance of Abbott, identify and qualify back-up vendors in the DMF and U.S. NDA and other equivalent regulatory filings as deemed necessary by the parties. It is recognized that LJP may have certain limitations during manufacturing start-up including a manufacturing learning curve, staffing, and raw material lead times. Abbott shall provide purchase orders and forecasts to LJP with sufficient notice and in sufficient quantities to allow LJP to meet its obligation to supply Substance. 4.2 Forecasts and Ordering - All forecasts will be reasonable and made in good faith with the understanding that LJP will rely on these forecasts for planning its 93 94 production infrastructure. With respect to the development and sale of Product in the Territory, Abbott shall deliver to LJP: (A) Preliminary Forecast - For clinical and manufacturing development planning purposes, and within *** of the Effective Date, a preliminary marketing forecast of Substance from Abbott. This forecast will be updated *** by Abbott until Abbott receives its initial Regulatory Approval. (B) Long Term Forecast - For long-term marketing and plant capacity planning purposes, within *** of the Effective Date a *** sales forecast for the Territory. This forecast will include a detailed projection of the quantities needed for launch and will be updated every *** by Abbott until *** years after the Initial Commercial Sale of the product, after which Abbott shall *** update such forecast. (C) Delivery Forecast - A *** rolling delivery forecast for the Territory. This Delivery forecast will be updated every *** by Abbott and used to determine orders for Substance as provided in Section 5 below. If a required forecast or order for any *** is not submitted for Substance within the required time frame, the immediately preceding forecast or order for that *** shall become the new forecast or order. (D) Orders Exceeding Forecast - Subject to the lead times associated with plant construction, equipment deliveries and other required deliveries, if orders exceed the forecast in Section 4.2 (B), then LJP is not obligated to supply Substance in excess of LJP's capacity. However, LJP will use Commercially Reasonable Efforts in cooperation with Abbott, to supply Abbott with Substance, in excess of the forecasted amounts. 94 95 (E) Manufacturing Plan - Based on the Manufacturing Plan, the parties will determine the timing, size and capacity of LJP's existing and future facilities as well as LJP approved subcontractors. The orders specified in the following sections shall conform to the plant capacities and timing of the Manufacturing Plan. Commencing not later than *** prior to Abbott's first commercial delivery date of the Substance from LJP for Abbott's Product launch anywhere in the Territory, Abbott will provide the *** , a firm purchase order for next *** and a *** forecast which is updated ***. Following the initial forecasts, an additional firm purchase order for at least *** (*** in the future) as well as an updated *** rolling forecast will be provided by Abbott. LJP shall not have to deliver an amount of Substance in excess of the forecast except when sufficient raw materials and manufacturing capacity are available. LJP will supply Abbott with forecasts for raw ingredients necessary to meet the *** forecast. During the first *** following Initial Commercial Sale, Abbott will purchase these specified raw ingredients and place them on consignment at LJP. LJP shall manufacture Substance for Abbott from raw ingredients supplied and paid for by Abbott. Such material supplied by Abbott shall be utilized by LJP solely for the purpose of formulating Abbott's requirements of the Substance. The raw materials shall be delivered F.O.B. LJP's plant pursuant to no cost purchase orders issued by LJP to Abbott. LJP shall render quarterly reports to Abbott accounting for the disposition of the raw materials supplied hereunder. LJP shall, for a period of *** after delivery, maintain accurate books and records showing raw ingredients in inventory, in process and shipments to Abbott. Abbott shall be permitted to conduct a physical inventory of the consigned inventory ***. LJP will deduct the cost of Abbott's supplied raw ingredients used to manufacture Substance from the price of Substance specified in Section 6 of this Supply Agreement. 95 96 LJP shall have the risk of loss or damage to the raw materials supplied hereunder from the time it is delivered to LJP and until the Substance is delivered to Abbott. LJP shall procure and maintain sufficient insurance to cover the cost of replacing consigned Inventory. 5. Supply - Subject to the terms and conditions of this Agreement, LJP shall use Commercially Reasonable Efforts to fill (by full or partial shipment) Abbott's orders for Substance for the Territory. 5.1 Purchase Orders - During the Term of this Agreement, Abbott may order Substance in amounts specified in Section 4.2(E) from LJP by submitting written Purchase Orders to LJP specifying the amount of Substance ordered, the location for delivery of such Substance (the "Delivery Location") and the required date(s) of delivery (the "Delivery Date"). A purchase order must be approved and signed by a representative of Abbott. LJP agrees to manufacture and sell to Abbott all Substance properly ordered and to deliver all such Substance to Abbott at the Delivery Location by the Delivery Date. LJP shall not be required to accept any purchase orders that are inconsistent with the terms of this Supply Agreement. Notification of non-acceptance of purchase orders must be provided to Abbott within *** after receipt of the Abbott purchase order. Each Purchase Order shall be governed by and subject to all the terms and conditions of this Agreement. LJP agrees to accept all properly placed Purchase Orders from Abbott for Substance. 6. Prices and Payment 6.1 Price of Substance and Interim Product for Development The price of the Substance or Interim Product sold by LJP to Abbott shall be ***. 96 97 6.2 Price of Substance for Product For Sale prior to Initial Commercial Sale - Prior to launch, the price of Substance shall be LJP's Fully Burdened Manufacturing Cost as specified in Appendix C, which will then be adjusted as specified in Section 8 of this Supply Agreement, Appendix G. 6.3 Price of Substance For Commercial Sale After Initial Commercial Sale - After the Initial Commercial Sale, the price of Substance sold for commercial sale anywhere in the Territory to Abbott by LJP shall be ***. (A) *** 97 98 (B) *** 6.4 *** (A) ***; or (B) ***. 7. Payments - Payments for Substance shipped to Abbott will be due within *** of invoice as described in Section 5.1 of the Agreement, which LJP shall issue when or after it ships Substance to Abbott. 8. Unit Net Sales Price - Abbott will provide good faith reasonable estimates of unit Net Sales price for Product at ***. Bona fide sample units and clinical trial units of Product will not be included in any calculations of average per unit Net Sales prices. Within *** of the end of each *** as specified in Section 4.3 of the Agreement for the reporting of royalties, Abbott shall provide a revised estimated unit Net Sales price for Products based on the ***. All such average unit Net Sales 98 99 prices will be based on ***. Accounts will be reconciled promptly within *** of the end of each *** during the first *** and then at the end of each *** thereafter to reflect actual Net Sales or costs and balancing payments which include ***. 9. Shipments 9.1. Delivery Location - LJP shall ship all Substance F.O.B. Plant to the Delivery Location specified in the Purchase Order or, unless the Substance has already been shipped, to such other location as may be requested by Abbott in writing not less than *** prior to the scheduled Delivery Date. Partial delivery of Substance shall not be permitted unless specifically authorized in writing by Abbott and LJP. 9.2. Other Delivery Costs - The price and payments for the Substance shall be exclusive of all insurance, shipping, import duties and taxes, inventory storage, disposal of returns, withholding and the like. These costs shall be added to the invoice and paid by Abbott. 9.3 Title and Risk of Loss - Title and risk of loss of Product sold under this Agreement shall pass to Abbott upon delivery of the same at the LJP shipping site to the carrier designated by Abbott, or, if no carrier is chosen by Abbott, upon delivery by LJP to a carrier chosen by LJP in a commercially reasonable manner. Thereafter, in addition to assuming all risk of loss, Abbott shall be responsible for compliance with all 99 100 governmental regulations and ordinances with regard to storage or placement of Products. LJP warrants that, upon delivery and acceptance of any Substance, title will pass to Abbott free and clear of all liens, claims, security interests or encumbrances and that no Substance purchased hereunder shall be subject to any agreement under which any interest therein or encumbrance thereon is retained by any third party. 10. Delivery - Substance delivered to Abbott pursuant to the terms hereof shall be deemed accepted by Abbott upon the earlier of (i) receipt by LJP of a written notice of acceptance from Abbott or (ii) expiration of the Inspection Period (as defined below) without rejection by Abbott of any such Substance. Abbott shall have the right to inspect the Substance at the Delivery Location within *** after delivery to the Abbott U.S. plants and *** after receipt at Abbott International plants before accepting such Substance (the "Inspection Period"). If any Substance is found to be defective in material or workmanship, or otherwise not in conformity with the mutually agreed upon requirements of the applicable Purchase Order, Abbott, in addition to any other rights it may have under warranty or otherwise, shall have the right to reject and return any or all such Substance on a carrier selected by LJP at LJP's expense and risk. 11. Certificate of Analysis - LJP shall furnish Abbott with one or more certificates of analysis, in the form required by law in each country of the Territory where the Product is marketed, for each batch of the Substance or the Interim Product supplied hereunder with shipment of each such batch. 12. Product Inspections 12.1 Abbott Inspection and Analysis - Abbott and LJP shall agree on validated test methods and shall work together to confirm the performance of these methods. Abbott shall inspect and analyze a representative sample of the Substance 100 101 from batches supplied by LJP promptly after receipt. If, after inspection, Abbott reasonably believes the shipment does not meet the Specifications, Abbott shall notify LJP in writing within *** after Abbott's receipt of such Substance. If Abbott does not so notify LJP, Abbott shall be deemed to have waived all claims against LJP for said quantity delivered, except for any latent deviations from the Specifications that could not have been reasonably discovered upon such inspection. Any claims by Abbott regarding Substance delivered shall specify in reasonable detail the nature and basis for the claim and cite relevant LJP lot numbers or other information to enable specific identification of the Substance involved. After stability data has been developed for the Substance, the Parties will agree on an acceptable expiration dating for Substance shipped to Abbott from LJP. 12.2 LJP Response - LJP shall respond to all claims made by Abbott on a case-by-case basis during which time LJP shall have the right to first inspect any Substance involved before being required to take any action with respect thereto. LJP shall review any such claim of nonconformity made by Abbott within *** of receipt and conduct any required testing of the Substance involved as soon as possible, but in no event later than *** after receipt thereof or earlier if the U.S. FDA or any corresponding regulatory authority in the Territory requires an earlier response from LJP. If such review and testing by LJP (or testing by an independent laboratory as set forth below) confirms that a claimed quantity does not meet the Specifications, then, at LJP's expense, Abbott shall dispose of or return such quantity involved as LJP shall direct in writing and LJP shall replace such quantity with conforming Substance as soon as possible, using Commercially Reasonable Efforts which shall be Abbott's sole and exclusive remedy for such non-conformity. If the Parties fail to agree as to whether a delivered quantity meets the Specifications, then the Parties shall have the batch in dispute analyzed by a mutually agreed upon 101 102 independent testing laboratory. Such laboratory's determination shall be deemed final as to any dispute over the Specifications and the non-prevailing Party shall bear the costs of such independent laboratory's testing. 13. Product Storage - Each Party shall properly store the Substance under conditions that will not adversely affect the quality or normal shelf life thereof. 14. Abbott Obligations - Abbott shall formulate fill, package Substance into Product to current Good Manufacturing Practices (CGMP) or equivalent standards. Abbott shall maintain *** of Substance and Product inventory. 15. Abbott's Labeling Obligation - Abbott shall be responsible for all labeling, inserts, promotional materials and any other materials which accompany, are distributed with, used or referred to in any way by Abbott, its Affiliates or Unaffiliated Sublicenses in connection with the Product. Such materials shall conform to all legal requirements in each country of the Territory in which the Product is sold. 102 103 APPENDIX H CORE COUNTRIES *** 103 104 APPENDIX I ROYALTY CALCULATION ASSOCIATED WITH PREMIUM DELIVERY SYSTEM EXAMPLE Basic Product Basic Product Selling Price *** Royalty Rate *** Royalty paid on sale *** Premium Delivery System Calculation Example 1 Basic Product Selling Price *** Premium System Selling Price *** Contribution of Basic Product *** Calculation of Basic Product Contribution *** Royalty calculation *** Premium Delivery System Calculation Example 2 Basic Product Selling Price *** Premium System Selling Price *** Contribution of Basic Product *** Calculation of Basic Product Contribution *** Royalty calculation *** 104
EX-10.36 4 EXHIBIT 10.36 1 EXHIBIT 10.36 STOCK PURCHASE AGREEMENT This Stock Purchase Agreement (this "AGREEMENT") is made and entered into as of December 23, 1996 by and between La Jolla Pharmaceutical Company, a Delaware corporation (the "COMPANY"), and Abbott Laboratories, an Illinois corporation (the "PURCHASER"). A. The Company and the Purchaser are parties to that certain License and Supply Agreement of even date herewith (the "LICENSE AGREEMENT") pursuant to which the Company and the Purchaser will cooperate in the development and marketing of LJP 394, the Company's drug candidate for lupus erythematosus. B. The purchase by the Purchaser of capital stock from the Company as described herein is an essential inducement to the Company to enter into the License Agreement. NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants hereinafter set forth, the Company and the Purchaser hereby agree as follows: 1. DEFINITIONS. Capitalized terms used herein and not otherwise defined shall have the meanings set forth below: "ADDITIONAL INVESTMENT RIGHT" has the meaning set forth in Section 2(b)(i). "ADDITIONAL SHARES" has the meaning set forth in Section 2(b)(i). "AFFILIATE" of a party means any person or entity controlling, controlled by, or under common control with such party, whether directly or indirectly through one or more intermediaries. For purposes of this definition, "control" (including, with correlative meanings, the terms "controlling," "controlled by" and "under common control with"), as used with respect to any person, shall mean the possession, directly or indirectly, of the power to direct or cause the direction of the management or policies of such person, whether through the ownership of voting securities, by agreement or otherwise. "BENEFICIAL OWNERSHIP" shall have the meaning provided in Rule 13d-3 under the Exchange Act. "BOARD" means the board of directors of the Company. "BUSINESS DAY" means any day other than a Saturday, Sunday, or other day on which commercial banking institutions in California or Illinois are authorized or obligated by law to be closed. "COMMON STOCK" means the Company's common stock, par value $.01 per share. 2 "EQUITY SECURITY" means any Voting Stock and any options, warrants, convertible securities, or other rights to acquire Voting Stock, but excluding any rights issued by the Company under any stockholder rights plan that may be implemented by the Company and securities issuable upon exercise of such rights. "EXCHANGE ACT" means the Securities Exchange Act of 1934, as amended. "FAIR MARKET VALUE" of the Common Stock as of any date of determination means the arithmetic mean of the reported last sale price of the Common Stock regular way on each of the 20 trading days immediately preceding such date of determination or, if no such sale takes place on any of such days, the average of the reported closing bid and asked prices regular way, in each case on the principal national securities exchange on which the Common Stock is listed or admitted to trading, or, if the Common Stock is not listed or admitted to trading on any national securities exchange, the closing sales prices, or, if there are no closing sales prices on any such days, the average of the closing bid and asked prices, in the Nasdaq Stock Market or other over-the-counter market as reported by the National Association of Securities Dealers Automated Quotation System, or, if not so reported, the fair market value of the Common Stock as estimated by a nationally recognized investment banking firm selected by Purchaser and acceptable to the Company in the exercise of its reasonable discretion, which estimate shall be prepared at the expense of the Company. "GOVERNMENTAL AUTHORITY" means any governmental, quasi-governmental, judicial, or regulatory agency or entity or subdivision thereof with jurisdiction over the Company or the Purchaser or any of their subsidiaries or any of the transactions contemplated by this Agreement. "INITIAL SHARES" has the meaning set forth in Section 2(a). "MATERIAL ADVERSE EFFECT" means a material adverse effect on the business, assets, results of operations, properties, or financial or operating condition of the Company, or the ability of the Company to perform its obligations under this Agreement or the License Agreement or consummate the transactions contemplated hereby. "PURCHASER INTEREST" means, as of any date, the percentage of the Total Voting Power Beneficially Owned by the Purchaser on such date. "REGISTRATION STATEMENT" means the Company's registration statement on Form S-3, Registration No. 333-04943, including all exhibits thereto and the final prospectus included therein. "SEC" means the Securities and Exchange Commission. "SEC REPORTS" means the Company's Annual Report on Form 10-K for the year ended December 31, 1995 and quarterly reports on Form 10-Q for the quarters ended March 31, 1996, June 30, 1996 and September 30, 1996, each as filed with the SEC and including all exhibits thereto. 2 3 "SECURITIES ACT" means the Securities Act of 1933, as amended. "SHARES" means the Initial Shares and any and all Additional Shares purchased pursuant to this Agreement. "STANDSTILL PERIOD" means the period beginning on the date of this Agreement and ending on the third anniversary of the date of this Agreement. "TOTAL VOTING POWER" means, at any date, the total number of votes that may be cast in the election of directors of the Company at any meeting of stockholders of the Company held on such date assuming all shares of Voting Stock were present and voted at such meeting, other than votes that may be cast only by one class or series of stock (other than Common Stock) or upon the happening of a contingency. "VOTING STOCK" means Common Stock and all other securities of the Company, if any, entitled to vote generally in the election of the Board. 2. SALE AND PURCHASE OF STOCK. (a) Initial Purchase. (i) Subject to Section 2(d), the Company shall sell and issue to the Purchaser, and the Purchaser shall purchase from the Company, One Million Fifty (1,000,050) shares of Common Stock (the "INITIAL SHARES") for an aggregate purchase price of Four Million Dollars ($4,000,000) (the "INITIAL PURCHASE PRICE"). The closing of the issuance and sale to the Purchaser of the Initial Shares (the "INITIAL CLOSING") shall occur at the Company's headquarters, or such other place as the parties may mutually agree, five Business Days after the execution and delivery of this Agreement by the Purchaser and the Company, or, if all of the conditions set forth in Section 2(d) have not been satisfied or waived as of that date, on the first Business Day thereafter that all of the conditions set forth in Section 2(d) have been satisfied or waived (the "INITIAL CLOSING DATE"). At the Initial Closing, the Purchaser shall deliver the Initial Purchase Price to the Company by wire transfer to the account specified on Schedule 1, and in exchange therefor the Company shall issue the Initial Shares to the Purchaser and deliver to the Purchaser's representative present at the Initial Closing or mail to the Purchaser, at the Purchaser's discretion, a valid stock certificate registered in the name of the Purchaser representing the Initial Shares. If the Purchaser elects to have the stock certificate mailed, the Company shall telecopy to the Purchaser a copy of such certificate concurrently with the Purchaser's delivery of the Initial Purchase Price. 3 4 (b) Additional Purchases. (i) Subject to the limitations set forth in Section 2(b)(ii), the Company shall have the right (the "ADDITIONAL INVESTMENT RIGHT") to require the Purchaser to purchase additional shares of Common Stock ("ADDITIONAL SHARES") during the 1997 and 1998 calendar years (the "EXERCISE PERIOD"). The Company, acting in its sole discretion, may exercise the Additional Investment Right at any time and from time to time during the Exercise Period by delivering a written notice (an "EXERCISE NOTICE") to the Purchaser stating the total consideration to be paid by the Purchaser for the Additional Shares being sold pursuant to such exercise of the Additional Investment Right (an "ADDITIONAL PURCHASE PRICE") and the date (which shall be a Business Day not fewer than five Business Days or more than ten Business Days after the Purchaser's receipt of the Exercise Notice) on which the purchase and sale of the Additional Shares subject to that notice is expected to take place. Each closing of the issuance and sale to the Purchaser of Additional Shares (each an "ADDITIONAL CLOSING") shall occur at the Company's headquarters, or such other place as the parties may mutually agree, on the date specified in the applicable Exercise Notice, or, if all of the conditions set forth in Section 2(e) have not been satisfied or waived as of that date, on the first Business Day thereafter that all of the conditions set forth in Section 2(e) have been satisfied or waived (each an "ADDITIONAL CLOSING DATE"). At each Additional Closing, the Purchaser shall deliver the Additional Purchase Price specified in the applicable Exercise Notice to the Company by wire transfer to the account specified in Schedule 1, and in exchange therefor the Company shall issue to the Company that number of Additional Shares as is determined by dividing the Additional Exercise Price delivered by the Fair Market Value of the Common Stock on such Additional Closing Date, and deliver to the Purchaser's representative present at the Additional Closing or mail to the Purchaser, at the Purchaser's discretion, a valid stock certificate registered in the name of the Purchaser representing such Additional Shares. If the Purchaser elects to have the stock certificate mailed, the Company shall telecopy to the Purchaser a copy of such certificate concurrently with the Purchaser's delivery of the Additional Purchase Price. (ii) Notwithstanding anything herein to the contrary, each exercise of the Additional Investment Right is subject to the following limitations: (A) The Purchaser shall not be obligated to pay more than Four Million Dollars ($4,000,000) in aggregate Additional Purchase Price in any calendar year, except as set forth in Section 2(b)(ii)(C) and except that if any Exercise Notice delivered after October 1, 1997 and before January 1, 1998 does not result in payment by Abbott of the Additional Purchase Price specified therein because the condition to Abbott's purchase obligation set forth in Section 2(e)(i)(E) is not satisfied or waived, then the amount of such unpaid Additional Purchase Price (the "UNPAID PRICE") shall be added to the maximum aggregate Additional Purchase Price that the Purchaser may (subject to satisfaction of the applicable conditions herein, including the condition in Section 2(e)(i)(E)) be obligated to pay in the calendar year of 1998, but only if the Company delivers before March 31, 1998 an Exercise Notice or Exercise Notices specifying, in the aggregate, an Additional Purchase Price at least equal to the Unpaid Price. 4 5 (B) In any calendar year that the Company exercises the Additional Investment Right, the aggregate Additional Purchase Price specified in any Exercise Notice delivered in that year must be at least Two Million Dollars ($2,000,000). (C) In no event shall the Purchaser be required to purchase pursuant to this Section 2(b) a number of Shares that, together with the Shares then owned by the Purchaser, would exceed 19% of the then outstanding shares of Common Stock of the Company (giving effect to the issuance to Purchaser), and the number of Additional Shares to be purchased on any Additional Closing Date shall, at the Purchaser's option, be reduced by such excess number of shares, provided that the Fair Market Value of the Shares not sold to the Purchaser in 1997 as a result of any such reduction shall be added to the maximum aggregate Additional Purchase Price that the Purchaser may (subject to satisfaction of the applicable conditions herein, including the condition in Section 2(b)(ii)(C)) be obligated to pay in 1998. (c) Company Discretion. The Purchaser acknowledges that exercise of the Additional Investment Right is within the Company's sole discretion, and that the Purchaser may be required to purchase Additional Shares at times when the Fair Market Value thereof is relatively high. The Purchaser has no right to purchase Additional Shares at any particular price other than as set forth in Section 2(e)(i)(E). (d) Conditions to the Purchase and Sale of the Initial Shares. (i) Conditions to the Purchaser's Obligation. The obligation of the Purchaser to purchase and pay for the Initial Shares shall be subject to the satisfaction (or waiver in writing by the Purchaser) on or prior to the Initial Closing Date of the following conditions. (A) The representations and warranties contained in Section 3 shall be true and correct in all material respects as of the Initial Closing Date, and the covenants and agreements contained herein to be performed by the Company on or prior to the Initial Closing Date shall have been performed in all material respects on or prior to the Initial Closing Date. (B) The Company shall have entered into, or be entering into concurrently herewith, the License Agreement. (C) The Company shall have delivered to the Purchaser the following documents: (1) a certificate signed by the Company's Chief Executive Officer, dated the Initial Closing Date, certifying that the conditions specified in Section 2(d)(i)(A) have been satisfied; (2) certified copies of resolutions duly adopted by the Company's Board of Directors authorizing the execution, delivery and performance of this 5 6 Agreement, the License Agreement, and the other transactions contemplated hereby and thereby; (3) certified copies of the Certificate of Incorporation and By-laws of the Company, each as in effect on the Initial Closing Date; (4) copies of any third party and governmental consents, approvals and filings required in connection with the consummation of the transactions contemplated hereby. (D) The purchase of the Initial Shares by the Purchaser hereunder, and the performance of the transactions contemplated hereby and by the License Agreement, shall not be prohibited by any applicable law, administrative or governmental rule or regulation or order of a court of competent jurisdiction; and no action, suit or proceeding shall exist or be threatened that would prevent, restrain or condition in any material respect the consummation of the transactions contemplated hereby or by the License Agreement. (E) All material consents and approvals of, or filings with, any third party or Governmental Authority required in connection with the execution and delivery of this Agreement and the License Agreement and the consummation of the transactions contemplated hereby and thereby shall have been obtained. (ii) Conditions to the Company's Obligation. The obligation of the Company to issue and sell the Initial Shares shall be subject to the satisfaction (or waiver in writing by the Company) on or prior to the Initial Closing Date of the following conditions: (A) The representations and warranties contained in Section 4 shall be true and correct in all material respects as of the Initial Closing Date, and the covenants and agreements contained herein to be performed by the Purchaser on or prior to the Initial Closing Date shall have been performed in all material respects on or prior to the Initial Closing Date. (B) The issuance and sale of the Initial Shares by the Company hereunder, and the performance of the transactions contemplated hereby and by the License Agreement, shall not be prohibited by any applicable law, administrative or governmental rule or regulation or order of a court of competent jurisdiction; and no action, suit or proceeding shall exist or be threatened that would prevent, restrain or condition in any material respect the consummation of the transactions contemplated hereby or by the License Agreement. (C) All material consents and approvals of, or filings with, any third party or Governmental Authority required in connection with the execution and delivery of this Agreement and the License Agreement and the consummation of the transactions contemplated hereby and thereby shall have been obtained 6 7 (D) The Purchaser shall have entered into, or be entering into concurrently herewith, the License Agreement. (e) Conditions to the Purchase and Sale of the Additional Shares. (i) Conditions to the Purchaser's Obligation. The obligation of the Purchaser to purchase and pay for the Additional Shares shall be subject to the satisfaction (or waiver in writing by the Purchaser) on or prior to the applicable Additional Closing Date of the following conditions: (A) The purchase of the Additional Shares by the Purchaser hereunder shall not be prohibited by any applicable law, administrative or governmental rule or regulation or order of a court of competent jurisdiction; and no action, suit or proceeding shall exist or be threatened that would prevent, restrain or condition in any material respect the consummation of such purchase. (B) All material consents and approvals of, or filings with, any third party or Governmental Authority required in connection with the purchase of the Additional Shares shall have been obtained. (C) On and prior to the Additional Closing Date, the License Agreement shall remain in full force and effect and no notice of termination of the License Agreement shall have been delivered by the Purchaser or the Company (and not cured or withdrawn) in accordance with the terms of the License Agreement. (D) The Company shall have delivered to the Purchaser a certificate signed by each of the Company's President and Chief Financial Officer, dated the date of the Exercise Notice, certifying, as of the date of the Exercise Notice, that each such officer knows of no event, condition or pending announcement that (1) has not been publicly disclosed, (2) is specifically applicable to the Company (as opposed to events, conditions or announcements likely to affect generally the market or companies similar to the Company), and (3) would reasonably be expected to have a material adverse effect on the Fair Market Value of the Common Stock. (E) The Fair Market Value of the Common Stock as of the applicable Additional Closing Date shall be at least $2.00 per share, provided that this condition shall not be applicable if the fact that the Fair Market Value of the Common Stock is less than $2.00 per share is attributable to (1) factors having an adverse effect on the public securities markets generally, (2) factors having an adverse effect on biotechnology or pharmaceutical stocks generally or stocks of biotechnology companies similar to the Company in terms of market capitalization, product mix or development stage or pipeline, or financial condition, or (3) any action or inaction of the Purchaser or any transaction between the Purchaser and any third party. (ii) Conditions to the Company's Obligation. The obligation of the Company to issue and sell the Additional Shares shall be subject to the satisfaction (or waiver 7 8 in writing by the Company) on or prior to the applicable Additional Closing Date of the following conditions: (A) The representations and warranties contained in Section 4 shall be true and correct in all material respects as of the Additional Closing Date, and the covenants and agreements contained herein to be performed by the Purchaser on or prior to the Additional Closing Date shall have been performed in all material aspects on or prior to the Additional Closing Date. (B) The issuance and sale of the Additional Shares by the Company hereunder shall not be prohibited by any applicable law, administrative or governmental rule or regulation or order of a court of competent jurisdiction; and no action, suit or proceeding shall exist or be threatened that would prevent, restrain or condition in any material respect the consummation of such issuance and sale. (C) All material consents and approvals of, or filings with, any third party or Governmental Authority required in connection with the issuance and sale of the Additional Shares shall have been obtained. (D) On and prior to the Additional Closing Date, the License Agreement shall remain in full force and effect and no notice of termination of the License Agreement shall have been delivered by the Purchaser or the Company (and not cured or withdrawn) in accordance with the terms of the License Agreement. 3. REPRESENTATIONS AND WARRANTIES OF THE COMPANY. The Company represents and warrants to the Purchaser as follows: (a) Organization and Standing: Articles and Bylaws. The Company (i) is a corporation duly incorporated, validly existing, and in good standing under the laws of Delaware, (ii) is qualified, licensed or domesticated as a foreign corporation in all jurisdictions where such qualification, license or domestication is required to own and operate its properties and conduct its business in the manner and at the places presently conducted; (iii) holds all franchises, grants, licenses, certificates, permits, consents and orders, all of which are valid and in full force and effect, from all state, federal and other domestic and foreign regulatory authorities necessary to own and operate its properties and to conduct its business in the manner and at the places presently conducted; and (iv) has full corporate power and authority to own, lease and operate its properties and assets and to carry on its business as presently conducted and as proposed to be conducted, except where the failure to be so qualified, licensed or domesticated, or to hold such franchises, grants, licenses, certificates, permits, consents and orders or to have such power and authority would not reasonably be expected to have a Material Adverse Effect. (b) Authorization. The Board has approved this Agreement and the License Agreement and the transactions contemplated hereby and thereby, and the Company has all requisite corporate power and authority to execute, enter into and carry out the terms and conditions of this Agreement and the License Agreement and to perform its obligations 8 9 hereunder and thereunder. This Agreement and the License Agreement have been duly executed and delivered by the Company and (assuming this Agreement and the License Agreement, as the case may be, constitute legal, valid, and binding obligations of the Purchaser) constitute legal, valid and binding obligations of the Company, enforceable in accordance with their respective terms, except that the enforceability of this Agreement and the License Agreement may be subject to bankruptcy, insolvency, reorganization, moratorium or other similar laws now or hereafter in effect relating to creditors' rights generally, and except that the remedy of specific performance and injunctive and other forms of equitable relief may be subject to equitable defenses and to the discretion of the court before which any proceeding therefor may be brought. (c) Capital Stock. The authorized, issued and outstanding capital stock of the Company consists solely of 32,000,000 shares of Common Stock and 8,000,000 shares of undesignated preferred stock, par value $0.01 per share, of which approximately 16,262,491 shares of Common Stock and no shares of preferred stock were issued and outstanding as of the date hereof. In addition, approximately 4,022,476 shares of Common Stock were reserved for issuance upon exercise of options and warrants outstanding as of the date hereof. All of the issued and outstanding securities of the Company have been duly authorized and validly issued, are fully paid and nonassessable, and were issued in compliance with all applicable state and federal laws regulating the offer, sale or issuance of securities (assuming, in the case of issuances not effected pursuant to an effective registration statement under the Securities Act, compliance with all such laws by the persons to whom such securities were issued or sold and by any transferee of such persons). No person or entity has or will have any right of first refusal or any preemptive rights in connection with the issuance of the Shares. The Shares have been duly authorized and, when delivered pursuant to this Agreement will be duly and validly issued and outstanding, fully paid and nonassessable, and free of any liens or restrictions (unless created by the Purchaser or any of its Affiliates), other than restrictions under applicable securities laws. Since the date of the final prospectus included in the Registration Statement, the Company has not granted any (i) shares of capital stock or Voting Stock of the Company, or (ii) securities of the Company convertible into or exchangeable for shares of capital stock or Voting Stock of the Company, other than options issued pursuant to the Company's 1994 Stock Incentive Plan with exercise prices equal to the fair market value of the Common Stock on the date of grant, and shares of Common Stock issued pursuant to the exercise of outstanding warrants or options. The Company does not own shares of capital stock or other equity interests in any other entity. There are no outstanding obligations of the Company or any of its subsidiaries to repurchase, redeem or otherwise acquire any securities. (d) No Violation. Neither the execution and delivery of this Agreement and the License Agreement nor the consummation and performance of the transactions contemplated hereby and thereby will (i) conflict with or result in a breach of the terms, conditions or provisions of, (ii) constitute a default under, (iii) result in the creation of any lien, claim or encumbrance upon the Company's capital stock or assets pursuant to, (iv) give any third party the right to accelerate any obligation under, (v) result in a violation of, or (vi) require any authorization, consent, approval, exemption or other action by or notice to any Governmental Authority pursuant to, the Certificate of Incorporation or By-Laws of the 9 10 Company, or any law, statute, rule or regulation to which the Company or any of its properties or assets are subject, or any agreement, instrument, order, judgment or decree to which the Company or any of its properties or assets are subject except where the event or circumstance described above would not have a Material Adverse Effect. (e) Reports and Financial Statements. The Company has furnished the Purchaser with copies of its Certificate of Incorporation, as amended to date, its Bylaws, as currently in effect, the Registration Statement, and the SEC Reports. The documents so furnished are true, correct and complete copies of the original documents. The Registration Statement and the SEC Reports, when filed with the Securities and Exchange Commission, complied in all material respects with all applicable federal securities laws and regulations. None of the SEC Reports or the Registration Statement, including, without limitation, any financial statements or schedules included or incorporated by reference therein, contained when filed any untrue statement of a material fact, or omitted when filed to state a material fact required to be stated or incorporated by reference therein or necessary in order to make the statements therein, in light of the circumstances under which made, not misleading. The audited financial statements of the Company included in the Registration Statement and the SEC Reports and the unaudited financial statements of the Company included in its quarterly reports on Form 10-Q for the quarters ended March 31, 1996, June 30, 1996 and September 30, 1996 fairly present, in conformity with generally accepted accounting principles applied on a consistent basis (except as may be indicated in the notes thereto), the financial position of the Company as of the dates thereof and the results of operations and changes in financial position of the Company for the periods then ended (subject, in the case of unaudited financial statements, to normal year-end audit adjustments). Except as set forth in the financial statements (and the footnotes thereto) included in the SEC Reports, there are no material liabilities, debts, claims or obligations, whether accrued, absolute, contingent or otherwise, of or affecting the Company or any of its properties or assets. (f) Absence of Changes. Since September 30, 1996, (i) the Company has not entered into any transaction that was not in the ordinary course of its business; and (ii) there has been no Material Adverse Effect. (g) Litigation. There is no litigation, claim, action, proceeding or investigation pending against the Company or, to the knowledge of the Company, any basis therefor or threat thereof. (h) Tax Matters. The Company has (i) timely filed all tax returns that are required to have been filed by it with all appropriate federal, state, county and local governmental agencies (and all such returns are true and correct in all material respects) and (ii) timely paid all taxes owed by it or which it is obligated to withhold from amounts owing to any employee (including, but not limited to, social security taxes), creditor or third party. (i) Offering. Subject to the accuracy of the Purchaser's representations in Section 4, the offer, issuance and sale of the Shares constitute transactions exempt from the registration and prospectus delivery requirements of Section 5 of the Securities Act and the 10 11 Company has obtained (or is exempt from the requirement to obtain) all qualifications, permits, and other consents required by all applicable U.S. state laws governing the offer, sale or issuance of securities. (j) Compliance with Laws. The Company is not in violation of any applicable law or any regulation or requirement (including, but not limited to, any law, regulation or requirement governing the quality of the environment), the violation of which might have a Material Adverse Effect, and the Company has not received notice of any such violation. (k) Environmental Matters. The Company has obtained all Environmental Permits and is in compliance with all Environmental Laws and Environmental Permits, except where failure to have obtained such permits or to have so complied would not result in any Material Adverse Effect. There is no civil, criminal or administrative claim, suit, proceeding or investigation pending or, to the best knowledge of the Company, threatened against the Company relating in any way to any Environmental Laws or Environmental Permits and the Company knows of no fact or circumstance (including, without limitation, any notice of potential liability) that would give rise to any such claim, suit, proceeding or investigation. "Environmental Laws" mean all laws applicable to the Company relating to pollution or protection of the environment or human safety including, without limitation, laws relating to emissions, discharges, releases of pollutants, contaminants, chemicals, or industrial, toxic or hazardous substances or wastes or otherwise regulated substances or wastes into the environment (including, without limitation, ambient air, surface water, ground water or land), or otherwise relating to the manufacture, processing, distribution, use, treatment, storage, disposal, transport or handling of pollutants, contaminants, chemicals or industrial, toxic, hazardous or other regulated substances or wastes. "Environmental Permits" mean all permits, licenses and authorizations required for the operation of the business of the Company under applicable Environmental Laws. (l) Patents, Copyrights and Trademarks. To the Company's knowledge after due investigation, (i) the Company owns or is licensed under all patents, patent applications, licenses, trademarks, trade names, brand names, inventions and copyrights necessary for the operation of its business as now conducted and as proposed to be conducted, with no infringement of or conflict with the rights of others, except where the failure so to own or be licensed would not have a Material Adverse Effect; and (ii) there have been no claims made against the Company for the assertion of the invalidity, abuse, misuse or unenforceability of any of its patent, trademark, copyright, trade secret or other proprietary rights and to the Company's knowledge there are no grounds for the same. (m) Disclosure. This Agreement does not contain any untrue statement of any material fact or omit to state a material fact necessary in order to make the statements contained herein, in light of the circumstances under which they were made, not misleading. 11 12 4. REPRESENTATIONS AND WARRANTIES OF THE PURCHASER. The Purchaser represents and warrants to the Company and its officers, directors and agents as follows: (a) Organization, Good Standing, and Qualification. The Purchaser is a corporation duly incorporated, validly existing, and in good standing under the laws of Illinois, and has all necessary power and authority under applicable law to own its property and to conduct its business as now owned and conducted. (b) Authority. The Purchaser has all requisite corporate power and authority to execute, enter into and carry out the terms and conditions of this Agreement and the License Agreement, and to perform its obligations hereunder and thereunder. This Agreement and the License Agreement have been duly executed and delivered by the Purchaser and (assuming this Agreement and the License Agreement, as the case may be, constitute the legal, valid, and binding obligations of the Company) constitute the legal, valid and binding obligations of the Purchaser, enforceable in accordance with their respective terms, except that the enforceability of this Agreement and the License Agreement may be subject to bankruptcy, insolvency, reorganization, moratorium or other similar laws now or hereafter in effect relating to creditors' rights generally, and except that the remedy of specific performance and injunctive and other forms of equitable relief may be subject to equitable defenses and to the discretion of the court before which any proceeding therefor may be brought. (c) No Violation. Neither the execution and delivery of this Agreement and the License Agreement nor the consummation of the transactions contemplated hereby and thereby will conflict with or result in the material breach of any term or provision of, or constitute a default under, any charter provision, bylaw, material contract, order, law or regulation to which the Purchaser or any of its Affiliates is a party or by which the Purchaser or any of its Affiliates or any of their respective material assets or properties is in any way bound or obligated. (d) Governmental Consents. No consent, approval, order or authorization of, or registration, qualification, designation, declaration or filing with, any Governmental Authority having jurisdiction over the business of the Purchaser or any of its Affiliates is required in connection with the transactions contemplated by this Agreement or the License Agreement, except where failure to obtain such would not have a Material Adverse Effect. (e) Brokers. No finder, broker, agent, financial advisor, or other intermediary has acted on behalf of the Purchaser or any of its Affiliates in connection with any of the transactions contemplated by this Agreement or the License Agreement or is entitled to any payment in connection herewith or therewith. (f) Ownership of Voting Stock. Neither the Purchaser nor any person with whom the Purchaser is acting as a partnership, limited partnership, syndicate or other group (within the meaning of Section 13(d)(3) of the Exchange Act) for the purpose of acquiring, holding or disposing of securities issued by the Company Beneficially Owns (directly or indirectly) any Common Stock as of the date of this Agreement other than the Shares being purchased by the Purchaser hereunder. 12 13 (g) Securities Matters. (i) The Purchaser acknowledges that an investment in the Company involves an extremely high degree of risk and that the Purchaser may lose its entire investment in the Shares. (ii) The Purchaser is acquiring the Shares without having been furnished any offering literature or prospectus specifically prepared in connection with the offer and sale of the Shares pursuant hereto. The Purchaser has received the SEC Reports and the Registration Statement and all additional information requested from the Company and acknowledges that the Company has made available to it or its advisors the opportunity to obtain additional information to evaluate the merits and risks of the purchase of the Shares. The Purchaser has had an opportunity to discuss the Company's business, management and financial affairs with the Company's management and to conduct such investigations and inquiries as the Purchaser deems appropriate for purposes of investment in the Shares pursuant to this Agreement. The Purchaser has read and understands the SEC Reports and the prospectus contained in the Registration Statement, including without limitation the "Risk Factors" section thereof, and acknowledges that the disclosures included therein constitute risks to the Purchaser in connection with the purchase of the Shares. The Purchaser has also read and understands the section of the prospectus contained in the Registration Statement entitled "Description of the Company's Securities" and understands the Company's capital structure and the substantial dilution to the Purchaser's interest in the Company that can occur upon the exercise of warrants and stock options. Without limiting the foregoing, the Purchaser acknowledges its understanding that (A) the Company will need substantial additional capital, which may be raised through sale of additional securities, thereby further diluting the Purchaser's interest in the Company, (B) the Company's drug candidate for the treatment of lupus erythematosus, LJP 394, may not prove effective in producing a sustained reduction of antibodies to double-stranded DNA and may not provide a meaningful clinical benefit, and (C) the Company's other drug candidates are at earlier stages of development and involve comparable risks. (iii) The Purchaser understands that (A) the Shares are neither registered under the Securities Act nor under the securities laws of any state or foreign country, (B) the certificates evidencing the Shares will bear a legend to the effect set forth in Section 5(b) (relating to restrictions on transfer), and (C) appropriate stop transfer instructions against the Shares will be placed with the Company's transfer agent. (iv) The Purchaser has expertise in evaluating and investing in companies like the Company and is able to assess the relative merits and risks of an investment in the Company and to sustain a total loss on such investment. (v) The Purchaser understands that, in addition to the contractual restrictions on transfer set forth in this Agreement, the Shares cannot be offered, sold or transferred unless the Shares are registered under the Securities Act or an exemption from the registration requirements of the Securities Act is available, or such registration requirements 13 14 are inapplicable, as reflected in an opinion of counsel to the Purchaser in form and substance reasonably satisfactory to the Company, in which case the Company agrees to cooperate reasonably with the Purchaser, including but not limited to, executing, acknowledging or delivering any documents which in the opinion of the Purchaser or its counsel may be reasonably necessary, appropriate or desirable in order to render such an opinion. (vi) The Purchaser is purchasing the Shares for its own account, for investment, not as a nominee or agent, and not with a view to their sale or distribution. 5. COVENANTS. (a) SEC Reports and Other Information. As soon as available (but in any event within five days after filing with the SEC or release), the Company shall deliver to the Purchaser copies of (i) all registration statements and all special or periodic reports relating to the Company that the Company files with the SEC or with any regional or national securities exchange or quotation system and (ii) all press releases. (b) Restrictions on Transfer. (i) During the Standstill Period, the Purchaser shall not offer, sell or transfer any Shares or any interest therein except as follows (provided that all such sales or transfers made during the Standstill Period, other than pursuant to Section 5(b)(i)(B) or (D), shall be subject to the Company's right of first refusal set forth in Section 5(c)): (A) to any person, entity or group approved in writing by the Company; (B) to any Affiliate of the Purchaser, if such Affiliate agrees in writing to hold such Shares subject to all the provisions of this Agreement and agrees to transfer such Shares to the Purchaser if it ceases to be an Affiliate of the Purchaser; (C) in response to an offer to purchase or exchange for cash or other consideration any Voting Stock that is made by or on behalf of the Company or by another person or group not opposed by the Board within the time the Board is required, pursuant to applicable rules under the Exchange Act, to advise the Company's stockholders of the Board's position on such offer; (D) pursuant to a bona fide pledge of such Shares to an institutional lender to secure a loan, guaranty or other financial support, provided that such lender agrees in writing to hold such Shares subject to all provisions of this Agreement; or (E) in the event of a merger or consolidation of the Company in which the holders of Voting Stock prior to the merger or consolidation cease to hold at least a majority of the Voting Stock of the surviving entity, or pursuant to a plan of liquidation of the Company. 14 15 (ii) After the Standstill Period and before the fifth anniversary of the date of this Agreement, the Purchaser shall not, directly or indirectly, sell or transfer any Shares except as allowed during the Standstill Period and as follows (provided that all such sales or transfers shall be subject to the Company's right of first refusal set forth in Section 5(c)): (A) pursuant to a bona fide public offering registered under the Securities Act, including an offering made through an underwriter or broker that takes the Shares for its own account with a view to the public distribution thereof, if the Purchaser takes and requires the underwriter or broker to take reasonable precautions to insure that such offering will not result in a sale of Beneficial Ownership of Voting Stock with aggregate voting power of five percent (5%) or more of the Total Voting Power then in effect to any single person or group; (B) into the public market pursuant to SEC Rule 144 under the Securities Act, if the Purchaser takes reasonable precautions to insure that such offering will not result in a sale by it or any underwriter, broker, or other person or entity acting on its behalf of Beneficial Ownership of Voting Stock with aggregate voting power of five percent (5%) or more of the Total Voting Power then in effect to any single person or group; or (C) in transactions not otherwise described herein if such transactions do not result, to Purchaser's knowledge, in any single person or group having Beneficial Ownership of Voting Stock with aggregate voting power of five percent (5%) or more of the Total Voting Power then in effect or increasing its Beneficial Ownership of Voting Stock by such amount. (iii) No transfer by the Purchaser of any Shares that is otherwise permissible hereunder shall be made unless (A) the Shares are registered under the Securities Act, (B) such transfer complies with the provisions of Rule 144 under the Securities Act or (C) an exemption from the registration requirements of the Securities Act is available and the Purchaser has provided to the Company (at the Purchaser's expense) an opinion of counsel to the Purchaser in form and substance reasonably satisfactory to the Company that such an exemption is available. The certificate or certificates evidencing the Shares will bear the restrictive legend set forth below. The legend imprinted on the certificates shall be removed and the Company shall issue a new certificate without such legend to the holder of such security if such security is registered under the Securities Act, the conditions for a permissible sale or transfer under Rule 144 have been complied with or in the opinion of counsel to the Purchaser reasonably satisfactory to the Company such legend is no longer required under the Securities Act. THE SECURITIES EVIDENCED BY THIS CERTIFICATE HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933 (THE "ACT") AND THE TRANSFER OF THE SECURITIES REPRESENTED BY THIS CERTIFICATE IS SUBJECT TO CERTAIN CONDITIONS SPECIFIED IN THE STOCK PURCHASE AGREEMENT, DATED AS OF DECEMBER 23, 1996, BETWEEN THE ISSUER (THE 15 16 "COMPANY") AND ABBOTT LABORATORIES, AND THE COMPANY RESERVES THE RIGHT TO REFUSE THE TRANSFER OF SUCH SECURITIES UNTIL SUCH CONDITIONS HAVE BEEN FULFILLED WITH RESPECT TO SUCH TRANSFER. A COPY OF SUCH CONDITIONS SHALL BE FURNISHED BY THE COMPANY TO THE HOLDER HEREOF UPON WRITTEN REQUEST AND WITHOUT CHARGE. (iv) The Company may give stop transfer and other instructions to its transfer agent to effect the provisions of this Section 5(b). (c) Company Right of First Refusal. If the Purchaser proposes to transfer any Shares at any time and from time to time before the fifth anniversary of the date of this Agreement, the Purchaser shall first give the Company written notice of its intention, describing the price and general terms of the proposed transfer and the identity of the proposed transferee, if known. The Company or its designee shall have fifteen (15) Business Days from the date of receipt of any such notice to agree to purchase all of the Shares proposed to be transferred for the price per Share and upon the general terms specified in the notice by giving written notice to the Purchaser. If the Purchaser proposes any transfer of Shares for consideration other than cash, the Company may exercise its right of first refusal and purchase such Shares for cash in an amount equal to the fair market value of the proposed non-cash consideration. If the Company does not exercise its right of first refusal, the Purchaser may transfer any Shares not purchased by the Company at the price and upon the general terms described in the notice provided to the Company, provided that if the Purchaser has not transferred such Shares within 120 days after the Company received notice of the Purchaser's intention to transfer Shares, or entered into a binding agreement within such 120-day period to transfer such Shares and transferred such Shares within 120 days of entering into such agreement, the Purchaser shall not thereafter transfer any Shares without first offering such Shares to the Company in the manner provided above. (d) Proxy Solicitations. Prior to the end of the Standstill Period, neither the Purchaser nor its Affiliates shall, directly or indirectly, (i) solicit, initiate or participate in any "solicitation" of "proxies" or become a "participant" in any "election contest" (as such terms are defined or used in Regulation 14A under the Exchange Act); call, or in any way participate in a call for, any special meeting of stockholders of the Company (or take any action with respect to acting by written consent of the Company's stockholders); request, or take any action to obtain or retain any list of holders of any securities of the Company; or initiate or propose any stockholder proposal or participate in the making of, or solicit stockholders for the approval of, one or more stockholder proposals; (ii) deposit any Voting Stock in a voting trust or subject them to any voting agreement or arrangements; (iii) form, join or in any way participate in a "group" (within the meaning of Section 13(d)(3) of Exchange Act) with respect to any Voting Stock (or any securities the ownership of which would make the owner thereof a Beneficial Owner of Voting Stock); (iv) otherwise act to control or influence the Company or its management, Board, policies or affairs in a manner not specifically contemplated by this Agreement or the License Agreement, including, without limitation, (A) soliciting or 16 17 proposing (other than on a non-public basis directly to the Company) to effect or negotiate any form of business combination, restructuring, recapitalization or other extraordinary transaction involving, or any change in control of, the Company, its Affiliates or any of their respective securities or assets, or (B) seeking Board representation or the removal of any of the Company's directors or a change in the composition or size of the Board; (v) disclose (other than non-public disclosure to the Company) any intent, purpose, plan or proposal with respect to this Agreement, the Company or its Affiliates or the Board, management, policies, affairs, securities or assets of the Company or its Affiliates that is inconsistent with this Agreement, including any intent, purpose, plan or proposal that is conditioned on, or would require the Company or any of its Affiliates to make any public disclosure relating to, any such intent, purpose, plan, proposal or condition; or (vi) assist, advise, encourage or act in concert with any person with respect to, or seek to do, any of the foregoing. Notwithstanding anything in the foregoing to the contrary, however, nothing in this Section 5(d) shall prohibit the Purchaser from engaging in any of the activities set forth in Section 5(d) in response and opposition to activities of the kind described in Section 5(d) initiated by any third party, provided that Purchaser shall not engage in any of the activities described in this Section 5(d) beyond the time such third party ceases such activities. (e) Covenants to Bind Purchasers. Until the fifth anniversary of the date of this Agreement, the Purchaser shall cause any acquiror or acquirors (including without limitation Affiliates) to whom or which the Purchaser transfers any Shares in any transaction or series of related transactions not made through The Nasdaq National Market (or such stock exchange as may be the primary exchange upon which the Company's common stock may trade from time to time) of any interest in Voting Stock with aggregate voting power of three percent (3%) or more of the Total Voting Power then in effect to agree to be bound by subsections (b), (c), and (d) of this Section 5, and the legend required by Section 5(b)(iii) shall not be removed from such shares. (f) Nasdaq Listing. The Company shall use its best efforts to keep effective the registration of the Common Stock under the Exchange Act with the SEC and maintain the listing or inclusion for quotation on the Nasdaq Stock Market of the Common Stock, and shall use its best efforts to file timely such information, documents and reports as the SEC or such other Governmental Authority may require or prescribe that the Company file in connection therewith. The Company will, at the request of the Purchaser or any of its Affiliates, advise in writing as to whether all reports required to be filed under the Exchange Act have been timely filed, and will file any other information which may be reasonably required in order to comply with Rule 144 under the Securities Act, or any other comparable rule or Securities Act exemption, as then in effect. (g) Public Announcements. Neither the Purchaser nor the Company shall issue any press release or other public statement with respect to the transactions contemplated by this Agreement without the prior written consent of the other, except as may be required by applicable law or by obligations pursuant to any listing agreement with a securities exchange or quotation system upon which the Purchaser's or the Company's securities are traded, provided that if either party believes that any press release or other public statement is so 17 18 required, such party shall promptly notify and consult with the other party with respect thereto. Without limitation of the foregoing, the Company shall not publicly announce any exercise of the Additional Investment Right until after the Additional Closing of the purchase and sale of the Additional Shares for which the Additional Investment Right was exercised. (h) Purchaser Right of First Refusal. If the Company proposes to issue or sell, at any time and from time to time before the fifth anniversary of the date of this Agreement, to any Designated Investor (as defined below), shares of Common Stock with aggregate voting power of 5% or more of the Total Voting Power (giving effect to such issuance or sale to such Designated Investor), the Company shall first give the Purchaser written notice of its intention, describing the price per share and general terms of the proposed transfer and the identity of the proposed transferee. The Purchaser or its designee shall have 15 Business Days from the date of receipt of any such notice to agree to purchase all of the shares of Common Stock proposed to be issued or sold for the price per share and upon the general terms specified in the notice by giving written notice to the Company. If the Company proposes any issuance or sale of shares of Common Stock for consideration other than cash, the Purchaser may exercise its right of first refusal and purchase such shares for cash in an amount equal to the fair market value of the proposed non-cash consideration. If the Purchaser does not exercise its right of first refusal, the Company may issue and sell the shares of Common Stock not purchased by the Purchaser at the price and upon the general terms described in the notice provided to the Purchaser, provided that if the Company has not transferred such shares within 120 days after the Purchaser received notice of the Company's intention to sell shares, or entered into a binding agreement within such 120-day period to issue and sell such shares and issued and sold such shares within 120 days after entering into such agreement, the Company shall not thereafter issue and sell any shares without first offering such shares to the Purchaser in the manner provided above. For purposes hereof, "DESIGNATED INVESTOR" means a pharmaceutical manufacturing or distribution company with operations in the field of care covering products specifically used to treat end-stage renal dialysis patients and patients with impaired renal function, such as polycystic disease, anemia, acute renal failure or glomerulonephritis, but not including renal transplantation ("RENAL CARE"). Notwithstanding the foregoing, however, the Purchaser's rights under this Section 5(h) shall not apply in the case of a sale of stock by the Company as part of a collaborative relationship involving research, development, manufacturing or marketing activities (a "PROPOSED COLLABORATION") unless the primary focus of the Proposed Collaboration is Renal Care, in which case the Purchaser's rights under this Section 5(h) will apply only if the Purchaser, through exercise of its right of first negotiation under Section 2.5 or Section 2.6 of the License Agreement, enters into a collaborative agreement with the Company with respect to the Proposed Collaboration, in which case the Purchaser shall have the right pursuant to this Section 5(h) to purchase any stock proposed to be sold as part of that Proposed Collaboration. 18 19 6. REGISTRATION RIGHTS. (a) Demand Registration Rights. (i) Demand; Obligations of the Company. At any time and from time to time after the third anniversary of the date of this Agreement, the Purchaser may request registration of all or any part of the Registrable Securities (a "DEMAND REGISTRATION"), and the Company will use its reasonable best efforts to effect the registration of such Registrable Securities under the Securities Act (including, if so requested by the Purchaser, Rule 415 thereunder), all in accordance with the following provisions. "REGISTRABLE SECURITIES" shall mean those shares of the Company's Common Stock acquired or acquirable by the Purchaser pursuant to this Agreement, any additional shares of Common Stock or other securities which subsequently may be issued with respect to such stock as a result of a stock split or dividend or any sale, transfer, assignment or other transaction involving such Common Stock or securities and any securities into which such Common Stock or securities may thereafter be exchanged or converted as a result of merger, consolidation, recapitalization or otherwise. (ii) Company's Ability to Postpone. The Company shall have the ability to postpone the filing of a registration statement under this Section 6(a) for a reasonable period of time (not exceeding 60 days) if the Company furnishes the Purchaser with a certificate signed by the President of the Company stating that the Company's board of directors has determined in good faith that effecting the registration at such time would adversely affect a material financing, acquisition, disposition of assets of stock, merger or other comparable transaction or would require the Company to make public disclosure of information the public disclosure of which could have a Material Adverse Effect. (iii) Number of Demand Registrations. If no Additional Shares have been issued, the Purchaser shall be entitled to an aggregate of two Demand Registrations. If any Additional Shares have been issued, the Purchaser shall be entitled to an aggregate of three Demand Registrations. (b) Demand Registration Procedures. If and whenever the Company is required under Section 6(a) to use its reasonable best efforts to effect the registration of any of the Registrable Securities under the Securities Act, the Company will (except as otherwise provided in this Agreement), as expeditiously as practicable: (i) prepare and file with the SEC a registration statement with respect to such Registrable Securities and use its reasonable best efforts to cause such registration statement to become effective and remain effective for the lesser of nine months or as long as shall be necessary to complete the distribution of the Registrable Securities so registered; (ii) prepare and file with the SEC such amendments and supplements to such registration statement and the prospectus used in connection therewith as may be necessary to keep such registration statement effective for the lesser of nine months or as long 19 20 as shall be necessary to complete the distribution of the Registrable Securities so registered and to comply with the provisions of the Securities Act with respect to the sale or other disposition of all Registrable Securities covered by such registration statement whenever the Purchaser shall desire to sell or otherwise dispose of the same; (iii) furnish to the Purchaser such numbers of copies of a prospectus, including a preliminary prospectus and any amendment or supplement to any prospectus, in conformity with the requirements of the Securities Act, and such other documents, as the Purchaser may reasonably request in order to facilitate the public sale or other disposition of the Registrable Securities owned by the Purchaser; (iv) use its reasonable best efforts to register and qualify the Registrable Securities covered by such registration statement under such other securities or blue sky laws of such jurisdictions as the Purchaser shall reasonably request, and do any and all other acts and things reasonably requested by the Purchaser to assist such holder to consummate the public sale or other disposition in such jurisdictions of the Registrable Securities, except that the Company shall not for any such purpose be required to qualify to do business as a foreign corporation in any jurisdiction wherein it is not so qualified or to file therein any general consent to service of process; (v) otherwise use its reasonable best efforts to comply with all applicable rules and regulations of the SEC, and make available to its security holders, as soon as reasonably practicable, an earnings statement covering the period of at least twelve months, beginning with the first fiscal quarter beginning after the effective date of the registration statement, which earnings statement shall satisfy the provisions of Section 11(a) of the Securities Act and Rule 158 thereunder with respect to the offer and sale of the Registrable Securities; (vi) use its reasonable best efforts to list such Registrable Securities on any securities exchange (or obtain approval for trading on the Nasdaq Stock Market) on which any securities of the same class of the Company are then listed (or approved for listing), if the listing (or approval for listing) of such Registrable Securities is then permitted under the rules of such exchange (or the Nasdaq Stock Market); (vii) if so requested by the Purchaser in connection with an underwritten offering, enter into and perform its obligations under an underwriting agreement, in usual and customary form, with the managing underwriter or underwriters, including, without limitation, to enter into customary representations, warranties, covenants and indemnification and contribution provisions and deliver an opinion of counsel to the Company and a "comfort letter" from the independent public accountants to the Company in the usual and customary form respecting such underwritten offering; (viii) notify the Purchaser promptly (i) when a prospectus or any prospectus supplement or post-effective amendment with respect to the registration of such Registrable Securities, or any report incorporated by reference therein, has been filed, (ii) of any request by the SEC for an amendment or supplement to a registration statement or the 20 21 prospectus used in connection therewith with respect to the Registrable Securities, or any report incorporated by reference therein, (iii) of the issuance by the SEC of any stop order suspending the effectiveness of a registration statement relating to the Registrable Securities or the initiation of any proceedings for that purpose, and (iv) of the receipt by the Company of any notification with respect to the suspension of the qualification of any of the Registrable Securities covered by such registration statement for sale in any jurisdiction or the initiation or threatening of any proceeding for that purpose; (ix) in the event of the issuance of a stop order suspending the effectiveness of a registration statement with respect to the Registrable Securities or the suspension of the qualification of any of the Registrable Securities covered by such registration statement for sale in any jurisdiction, use its reasonable best efforts to obtain the withdrawal of such stop order or the lifting of such suspension at the earliest possible moment; and (x) notify the Purchaser, at any time when a prospectus relating to the Registrable Securities covered by such registration statement is required to be delivered under the Securities Act, of the happening of any event of which it has knowledge as a result of which the prospectus included in such registration statement, as then in effect, contains an untrue statement of a material fact or omits to state a material fact required to be stated therein or necessary to make the statements therein not misleading in the light of the circumstances then existing and promptly prepare and furnish to the Purchaser (and the underwriters, if any) a reasonable number of copies of a supplement to or an amendment of the prospectus as may be necessary so that, as thereafter delivered to the purchasers of the Registrable Securities, the prospectus shall not contain an untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary to make the statements therein not misleading in the light of the circumstances then existing. (c) Incidental Registration Rights. (i) If the Company proposes to register any of its securities under the Securities Act (other than on Form S-4, Form S-8 or any successor forms thereto), whether in connection with a primary or secondary offering (a "PROPOSED OFFERING"), the Company shall give written notice to the Purchaser at least 30 days prior to the initial filing of the registration statement with the SEC pertaining to such Proposed Offering informing the Purchaser of its intent to file such registration statement and of the Purchaser's rights under this Section 6(c). Upon the written request of the Purchaser made within 15 days after any such notice is received by the Purchaser (which request shall specify the Registrable Securities intended to be disposed of by the Purchaser), the Company shall use its reasonable best efforts to effect the registration (an "INCIDENTAL REGISTRATION") under the Securities Act of all the Registrable Securities which the Company has been so requested to register by the Purchaser. The registration rights granted pursuant to this Section 6(c) shall be in addition to the registration rights granted pursuant to the other provisions of this Agreement. The Company further agrees, if necessary, to supplement or amend the Incidental Registration statement, if required by the rules, regulations or instructions applicable to the registration form used by the Company for such Incidental Registration statement or by the Securities Act or by any other 21 22 rules and regulations thereunder for registration. The Purchaser shall be permitted to withdraw all of the Registrable Securities from an Incidental Registration statement at any time prior to the effective date of the Incidental Registration statement; provided, however, that any withdrawal shall be irrevocable with respect to such Incidental Registration statement. Any request by the Purchaser to include Registrable Securities pursuant to this Section 6(c) shall not be deemed a Demand Registration. (ii) If the managing underwriter or underwriters of a Proposed Offering delivers a written opinion to the Purchaser that the success of the Proposed Offering would be materially and adversely affected by inclusion of any or all of the Registrable Securities requested to be included, then the amount of Registrable Securities included in the Incidental Registration may in the Company's discretion be reduced to the extent (including reduction to zero) recommended by such underwriter or underwriters. Notwithstanding the foregoing, however, if securities are being offered for the account of persons other than the Company or the Purchaser, then, with respect to the Registrable Securities to be offered for the account of the Purchaser, the proportion by which the amount of such Registrable Securities intended to be offered by the Purchaser is reduced shall not exceed the proportion by which the amount of such class of securities intended to be offered by such other persons is reduced. (iii) If at any time after giving written notice of its intent to register any securities and prior to the effective date of the Incidental Registration statement filed in connection with such registration, the Company shall determine for any reason not to register any such securities or to delay registration of all such securities, the Company may, at its election, give written notice of such determination to the Purchaser and, thereupon, (A) in the case of a determination not to register, the Company shall be relieved of its obligation to register any Registrable Securities in connection with such registration, and (B) in the case of a determination to delay registering, the Company shall be permitted to delay registering any Registrable Securities for the same period as the delay in registering such other securities. (d) Expenses. (i) All expenses incurred in a Demand Registration or an Incidental Registration (or any attempted Demand Registration or Incidental Registration which does not become effective) of Registrable Securities under this Agreement shall be paid by the Company, except as set forth in Section 6(d)(iii). (ii) The expenses to be paid in connection with a registration under Sections 6(a), 6(b) and 6(c) shall include all out-of-pocket expenses, including, without limitation, printing and photocopying expenses, fees and disbursements of counsel for the Company, accountants' fees and expenses, including expenses of any special audits to which the Company shall agree or which shall be necessary to comply with governmental requirements in connection with any such registration, as applicable, all registration and filing fees under federal and state securities laws, fees and expenses (including fees and disbursements of counsel for the Company) of complying with the securities or blue sky laws 22 23 of any jurisdictions and listing or qualification fees or other expenses (including fees and disbursements of counsel for the Company) of complying with the listing, qualification or other rules of any national securities exchange or any other self regulatory organization. (iii) Notwithstanding the foregoing provisions of this Section 6(d), the Purchaser shall pay fees and disbursements of its own counsel and all underwriting discounts and commissions and transfer taxes, if any, relating to the sale or disposition of securities by the Purchaser pursuant to a Demand Registration or an Incidental Registration. (e) Indemnification. If any Registrable Securities are included in a registration statement pursuant to a request under this Section 6: (i) Indemnity by Company. Without limitation of any other indemnity provided to the Purchaser, to the extent permitted by law, the Company shall indemnify and hold harmless the Purchaser, the officers and directors of the Purchaser, each underwriter (as defined in the Securities Act) for the Purchaser, and each person, if any, who controls (within the meaning of the Securities Act or Exchange Act) the Purchaser or any such underwriter, against any losses, claims, damages, liabilities and expenses (joint or several) to which they may become subject under the Securities Act, the Exchange Act or other federal or state law, insofar as such losses, claims, damages, liabilities and expenses (or actions in respect thereof) arise out of or are based upon any of the following statements, omissions or violations (collectively, a "Violation"): (A) any untrue statement or alleged untrue statement of a material fact contained in such registration statements (including any preliminary prospectus or final prospectus contained therein or any amendments or supplements thereto); (B) the omission or alleged omission to state therein a material fact required to be stated therein, or necessary to make the statements therein, in light of the circumstances under which they were made, not misleading; or (C) any violation or alleged violation by the Company of the Securities Act, the Exchange Act, any state blue sky or securities law or any rule or regulation promulgated under the Securities Act, the Exchange Act or any state blue sky or securities law, and the company shall reimburse the Purchaser, each officer or director of the Purchaser, each such underwriter for the Purchaser, and each person, if any, who controls (within the meaning of the Securities Act or Exchange Act) the Purchaser or any such underwriter for any expenses incurred by them (including reasonable fees and disbursements of counsel) in connection with investigating or defending any such loss, claim, damage, liability, expense or action; provided, however, that the Company shall not be liable to the Purchaser, the officers or directors of the Purchaser, any such underwriter for the Purchaser, or any person who controls (within the meaning of the Securities Act or Exchange Act) the Purchaser or any such underwriter, in any such case for any such loss, claim, damage, liability, expense or action to the extent that it arises out of or is based upon a Violation which occurs in reliance upon and in conformity with written information furnished expressly for use in connection with such registration by the Purchaser, any officer or director of the Purchaser, any underwriter for the Purchaser or any controlling person of the Purchaser or any such underwriter. 23 24 (ii) Indemnity by the Purchaser. In connection with any registration statement, as applicable, in which the Purchaser is participating, the Purchaser shall furnish to the Company in writing such information as the Company reasonably requests for use in connection with any such registration statement or prospectus, and, to the extent permitted by law, shall indemnify the Company, its directors and officers and each person, if any, who controls the Company (within the meaning of the Securities Act or Exchange Act) against any losses, claims, damages, liabilities and expenses resulting from any Violation, but only to the extent that such Violation is contained in or results from any information so furnished in writing by the Purchaser. (iii) Notice; Right to Defend. Promptly after receipt by an indemnified party under this Section 6(e) of notice of the commencement of any action (including any governmental action), such indemnified party shall, if a claim in respect thereof is to be made against any indemnifying party under this Section 6(e), deliver to the indemnifying party a written notice of the commencement thereof and the indemnifying party shall have the right to participate in, and, if the indemnifying party agrees in writing that it will be responsible for any costs, expenses, judgments, damages and losses incurred by the indemnified party with respect to such claim, jointly with any other indemnifying party similarly noticed, to assume the defense thereof with counsel mutually satisfactory to the parties; provided, however, that an indemnified party shall have the right to retain its own counsel, with the fees and expenses to be paid by the indemnifying party, if the indemnified party reasonably believes that representation of such indemnified party by the counsel retained by the indemnifying party would be inappropriate due to actual or potential differing interests between such indemnified party and any other party represented by such counsel in such proceeding. The failure to deliver written notice to the indemnifying party within a reasonable time of the commencement of any such action shall relieve such indemnifying party of any liability to the indemnified party under this Section 6(e) only if and to the extent that such failure is prejudicial to its ability to defend such action, and the omission so to deliver written notice to the indemnifying party shall not relieve it of any liability that it may have to any indemnified party other than under this Section 6(e). (iv) Contribution. If the indemnification provided for in this Section 6(e) is held by a court of competent jurisdiction to be unavailable to an indemnified party with respect to any loss, liability, claim, damage or expense referred to therein, then the indemnifying party, in lieu of indemnifying such indemnified party thereunder, shall contribute to the amount paid or payable by such indemnified party as a result of such loss, liability, claim, damage or expense in such proportion as is appropriate to reflect the relative fault of the indemnifying party on the one hand and of the indemnified party on the other hand in connection with the statements or omissions or Violations which resulted in such loss, liability, claim, damage or expense as well as any other relevant equitable considerations. The relative fault of the indemnifying party and the indemnified party shall be determined by reference to, among other things, whether the untrue or alleged untrue statement of a material fact or the omission or alleged omission to state a material fact relates to information supplied by the indemnifying party or by the indemnified party and the parties' relative intent, knowledge, access to information and opportunity to correct or prevent such statement or omission. 24 25 Notwithstanding the foregoing, the amount the Purchaser shall be obligated to contribute pursuant to this Section 6(e)(iv) shall be limited to an amount equal to the proceeds to the Purchaser of the Common Stock sold pursuant to the registration statement, which gives rise to such obligation to contribute (less the aggregate amount of any damages which the Purchaser has otherwise been required to pay in respect of such loss, claim, damage, liability or action or any substantially similar loss, claim, damage, liability or action arising from the sale of such Common Stock). (v) Survival of Indemnity. The indemnification provided by this Section 6(e) shall be a continuing right to indemnification and shall survive the registration and sale of any securities by any person entitled to indemnification hereunder and the expiration or termination of this Agreement. (f) Rule 144. In order to permit the Purchaser to sell the Common Stock it holds, if it so desires, from time to time pursuant to Rule 144 promulgated by the SEC or any successor to such rule or any other rule or regulation of the SEC that may at any time permit the Purchaser to sell its Common Stock to the public without registration (the "RESALE RULES"), the Company shall: (i) comply with all rules and regulations of the SEC applicable in connection with use of the Resale Rules; (ii) make and keep adequate and current public information available (within the meaning of the Resale Rules) at all times; (iii) file with the SEC in a timely manner all reports and other documents required of the Company under the Securities Act and the Exchange Act; (iv) furnish to the Purchaser so long as it owns any Common Stock, forthwith upon request, (A) a written statement by the Company that it has complied with the reporting requirements of the Resale Rules, the Securities Act and the Exchange Act, (B) a copy of the most recent annual or quarterly report of the Company and any other reports and documents so filed by the Company, and (C) such other information as may be reasonably requested in availing the Purchaser of any rule or regulation of the SEC which permits the selling of any such Common Stock without registration; and (v) take any action (including cooperating with the Purchaser to cause the transfer agent to remove any restrictive legend on certificates evidencing shares of Common Stock) as shall be reasonably requested by the Purchaser or which shall otherwise facilitate the sale of Common Stock from time to time by the Purchaser pursuant to the Resale Rules. 25 26 7. TERMINATION. (a) Termination Events. The Purchaser or the Company may terminate this Agreement without liability: (i) to the extent that performance thereof is prohibited, enjoined or otherwise materially restrained by any final, non-appealable judgment, ruling, order or decree of any Governmental Authority, provided that the party seeking to terminate its obligations hereunder pursuant to this Section 7(a)(i) shall have used its best efforts to avoid and remove such prohibition, injunction, or restraint; or (ii) if the terminating party shall not have committed a material uncured breach of any of its representations, warranties or covenants hereunder and the other party shall have breached any of its representations, warranties or covenants hereunder in any material respect, which breach in the case of a covenant is not cured within thirty (30) days after the breaching party has received notice of the terminating party's intent to terminate this Agreement pursuant to this Section 7(a)(ii). (b) Effect of Termination. In the event of termination of this Agreement pursuant to Section 7(a), neither the Purchaser nor the Company shall have any obligation to perform hereunder from and after the date of such termination, except that (i) Sections 8(a) and 8(b) shall survive such termination and continue in effect, (ii) Section 5 shall survive such termination and continue in effect if the termination is for any reason other than a material breach by the Company, and (iii) no termination hereof shall relieve the Purchaser or the Company from liability for any breach of this Agreement. 8. MISCELLANEOUS PROVISIONS. (a) Survival of Representations and Warranties. Regardless of any party's investigations prior to the date hereof, the representations and warranties contained herein shall survive the execution and delivery hereof and the purchase and sale of the Shares and shall terminate and expire on the first anniversary of the date of this Agreement, unless on or before such first anniversary, either party has notified the other party in writing of a claim with respect to such representation or warranty in which case such representation or warranty shall survive until termination or resolution of such claim, and provided that notwithstanding the foregoing, the representations and warranties of the Purchaser set forth in Section 4(g) shall be deemed to be made by the Purchaser at the time of and in connection with each acquisition of Shares hereunder. (b) Governing Law; Consent to Jurisdiction. This Agreement shall be governed by and construed under and enforced in accordance with the laws of the State of California without regard to its conflicts-of-laws principles. (c) Expenses. Except as set forth in Section 6(d), each of the parties shall pay its own expenses incurred in connection with the negotiation and preparation of this Agreement and the License Agreement, the performance of its covenants herein, and the effectuation of 26 27 the transactions contemplated hereby including, without limitation, all fees and disbursements of its respective legal counsel, advisors, and accountants. Each party to this Agreement shall indemnify and hold harmless the other against any claim for fees or commissions of brokers, finders, agents, or bankers retained or purportedly retained by the indemnifying party in connection with the transactions contemplated by this Agreement and the License Agreement. (d) Notices. In case of any event or circumstance giving rise to an obligation of the Purchaser or the Company to provide notice hereunder, such notice shall be delivered within the time specifically set forth herein or therein, as the case may be, or, if no such time is specified, then as promptly as practicable after becoming aware of such event or circumstance. Any notice required or permitted to be given under this Agreement shall be written, and may be given by personal delivery, by cable, telecopy, telex or telegram (with a confirmation copy mailed as follows), by a reputable commercial delivery service, or by registered or certified mail, first-class postage prepaid, return receipt requested. Notice shall be deemed given upon actual receipt. Mailed notices shall be addressed as follows, but each party may change address by written notice in accordance with this paragraph. To the Company: La Jolla Pharmaceutical Company 6455 Nancy Ridge Drive San Diego, California 92121 Attention: Chief Executive Officer Facsimile: (619) 452-6893 with a copy to: Gibson, Dunn & Crutcher LLP 4 Park Plaza, Suite 1800 Irvine, CA 92614 Facsimile: (714) 451-4220 Attention: Brian W. Copple, Esq. To the Purchaser: Abbott Laboratories Hospital Products Division Attn: President Dept. 0960, Bldg. AP30 200 Abbott Park Road Abbott Park, Illinois 60064-3500 Facsimile: (847) 937-2927 and 27 28 Abbott Laboratories Abbott International Attn: President Dept. 06WP, Bldg. AP30 200 Abbott Park Road Abbott Park, Illinois 60064-3500 Facsimile: (847) 938-8325 with a copy to: Abbott Laboratories General Counsel Dept. 364, Bldg AP6C 100 Abbott Park Road Abbott Park, Illinois 60064-3500 Facsimile: (847) 938-1206 (e) Waiver. Each party hereto may in its sole discretion (i) extend the time for the performance of any of the obligations or other acts of the other party hereunder, (ii) waive any inaccuracies in the representations and warranties of the other party contained herein or in any document, certificate or writing delivered pursuant hereto or thereto or (iii) waive compliance by the other party with any of the agreements contained herein. No term or provision hereof shall be deemed waived and no breach hereof or thereof excused unless such waiver or consent shall be in writing and signed by the party claimed to have waived or consented. No waiver hereunder shall apply or be construed to apply beyond its expressly stated terms. No failure to exercise and no delay in exercising any right, remedy, power or privilege hereunder shall operate as a waiver thereof, and no single or partial exercise of any right, remedy, power or privilege hereunder shall preclude any other or further exercise thereof or the exercise of any other right, remedy, power or privilege. No failure to insist upon strict performance of any term or provision of this Agreement, or to exercise any right hereunder, shall be construed as a waiver or as a relinquishment of such term, provision, or right. (f) Entire Agreement. This Agreement and the License Agreement constitute the entire agreement between the Purchaser and the Company with respect to the subject matter hereof and thereof and the transactions contemplated hereby and thereby and supersede all prior or contemporaneous, written or oral agreements or understandings with respect thereto. The parties acknowledge that their agreements hereunder were not procured through representations or agreements not set forth herein or therein. (g) Amendment. This Agreement may be amended only to the extent permissible under applicable law and only by a written instrument executed and delivered by a duly authorized officer of each of the parties hereto. (h) Severability. The provisions set forth in this Agreement are severable. If any provision of this Agreement is held invalid or unenforceable in any jurisdiction, the 28 29 remainder of this Agreement and the application of such provision to other persons or circumstances, shall not be affected thereby, and shall remain valid and enforceable in such jurisdiction, and any such invalidity or unenforceability in any jurisdiction shall not invalidate or render unenforceable such provision in any other jurisdiction. (i) Successors and Assigns. This Agreement shall be binding upon and inure to the benefit of the parties hereto and their successors and assigns, provided that neither party may assign this Agreement without the written consent of the other party; provided, however, that (i) either party hereto may assign this Agreement to any person or entity with or into which such party may merge or consolidate or to whom all or substantially all of its assets or businesses may be sold and (ii) the Purchaser may assign its rights under this Agreement to any subsidiary of the Purchaser if the Purchaser remains responsible for the subsidiary's performance and liable for its breaches of this Agreement. (j) Fair Construction. This Agreement shall be deemed the joint work product of the parties hereto without regard to the identity of the draftsperson, and any rule of construction that a document shall be interpreted or construed against the drafting party shall not be applicable. (k) Headings; References. Headings used in this Agreement are inserted as a matter of convenience and for reference, do not constitute a part of this Agreement for any other purpose, and shall not affect the interpretation or enforcement hereof. References herein to Sections and Schedules are, unless otherwise designated, references to the specified Section or Schedule hereof or hereto. (l) Counterparts. This Agreement may be executed in counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. IN WITNESS WHEREOF, the parties hereto have executed and delivered this Agreement as of the date first above written. LA JOLLA PHARMACEUTICAL COMPANY ABBOTT LABORATORIES By: /s/ Steven B. Engle By: /s/ Robert L. Parkinson, Jr. --------------------- ----------------------------- Name: Steven B. Engle Name: Robert L. Parkinson, Jr. Title: President & Chief Executive Officer Title: Senior Vice-President, International Operations 29 EX-23.1 5 EXHIBIT 23.1 1 EXHIBIT 23.1 CONSENT OF ERNST & YOUNG LLP, INDEPENDENT AUDITORS We consent to the incorporation by reference in (i) the Registration Statement (Form S-8 No. 33-82664) pertaining to the 1994 Stock Incentive Plan, (ii) the Registration Statement (Form S-8 No. 33-94830) pertaining to the 1995 Employee Stock Purchase Plan, and (iii) the Registration Statement (Form S-8 No. 333-14285) pertaining to the 1994 Stock Incentive Plan of La Jolla Pharmaceutical Company of our report dated January 30, 1997 with respect to the financial statements of La Jolla Pharmaceutical Company included in this Annual Report (Form 10-K) for the year ended December 31, 1996. ERNST & YOUNG LLP San Diego, California March 27, 1997 EX-27 6 FINANCIAL DATA SCHEDULE
5 1,000 YEAR DEC-31-1996 JAN-01-1996 DEC-31-1996 6,613 17,621 4,000 0 0 1,233 4,547 3,186 31,687 3,581 168 0 0 173 27,765 31,687 0 4,000 0 0 14,583 0 183 (9,596) 0 (9,596) 0 0 0 (9,596) (.63) (.63)
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